Oct-Dec, 2011 - Indian Journal of Pharmacy Practice

Indian Journal of Pharmacy PracticeijoppThe Official Publication of APTIEDITOR - IN - CHIEFDr. Shobha Rani R. HiremathShobha24@yahoo.comASSOCIATE EDITORSDr. G. ParthasarathiPartha18@airtelmail.inDr. Pramil Tiwariptiwari@niper.ac.inASSISTANT EDITORSMr. Ramjan Shaikramjanshaik@gmail.comMrs. Mahvash Irammahvashiram@gmail.comEditorial Board MembersDr. Anil Kumar, ChattisgarhDr. Atmaram P. Pawar, PuneDr. Claire Anderson, Nottingham, UKDr. Dhanalakshmi Iyer, MumbaiProf. Ganachari M S, BelgaumDr. Geeta.S, BangaloreDr. Hukkeri V.I, Ratnagiri (Dist)Dr. Krathish Bopanna, BangaloreProf. Mahendra Setty C.R, BangaloreDr. Miglani B D, New DelhiDr. Mohanta G.P., Annamalai NagarDr. Nagavi B.G, Ras Al-Khaimah, UAEDr. Nalini Pais, BangaloreDr. Rajendran S.D, HyderabadDr. Ramananda S.Nadig, BangaloreDr. Revikumar K G, CochinDr. Sampada Patawardhan, MumbaiDr. Sriram. S, CoimbatoreDr. Sreekant Murthy, Philadelphia, USADr. Sunitha C. Srinivas, Grahamstown, RSADr. Suresh B, MysoreDr. Tipnis H.P, MumbaiDisclaimer: The editor-in-chief does not claim any responsibility,liability for statements made and opinions expressed by authorsEDITORIAL OFFICEINDIAN JOURNAL OF PHARMACY PRACTICEAn Official Publication of Association of Pharmaceutical Teachers of IndiaH.Q.: Al-Ameen College of Pharmacy,Opp. Lalbagh Main Gate, Hosur Road, Bangalore 560 027, INDIAMobile: +91 9845399431 | +91 9845659585 | +91 9900434646+91 9916069842 | Ph: +91 80 22234619; Fax: +91 80 22225834Printed and Published by: Prof. B.G. Shivananda, Secretary, on behalf of Association of Pharmaceutical Teachers of IndiaPrinted at : Graphic Point, #55/44, 4th ‘B’ Cross, K.S. Garden, lalbagh Road, Bangalore - 560 027. Ph: 080-2227310www.ijopp.org | ijopp@rediffmail.com

Indian Journal of Pharmacy PracticeijoppEditorialReview ArticlesCombating Antimicrobial Resistance: 2011 is the year of “No action today, No cure tomorrow”Daxesh M. P, Ganachari M. S, Sunitha C.S .............................................................................................................................2 - 8India's Progress towards the health related Millennium Development Goals - Child MortalityPatel I,Chang J, Srivastava J , Patel I, Balkrishnan R ........................................................................................................ 9 - 13Poison Information Center-An Overview of its Significance, Organization and FunctioningShobha C, Ramesh M, Parthasarathi G.................................................................................................................................14-20ContentsHealth Related Quality of Life InstrumentsMuragundi P.M, Anil T.M, Ranjan S.K, Udupa N, Anantha N.N ......................................................................................... 21 - 28Research ArticlesScenario of Pharmacovigilance and ADR Reporting among Pharmacists in DelhiAmrita P, Roomi M.T ............................................................................................................................................................29 - 38Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with AsthmaRamesh A, Satyanarayana V, Rajani M, Rajani V .............................................................................................................. 39 - 48Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyDinesh K.U , Mohamed Izham M.I,Alurkar V.M, Pranaya M ............................................................................................... 49 - 61A Retrospective Study of Nosocomial infections in Patients Admitted in M.I.C.UPratham R, Manmohan S, Vipin R ...................................................................................................................................... 62 - 65Impact of Clinical Pharmacists Counseling on Quality of Life in patients with Congestive Cardiac Failure.Anoop P, Radhika N, Selvamuthu K.S, Saravanakumar R.T, Madhusudhan S, Mohanta G.P ....................................... 66 -72Respiratory Tract Problems associated with allergies in Punjab region, India- A survey reportSingh B, Mallik S, Kumar N, Ali M ,Mehra R.K , Kumar P ................................................................................................... 73 - 76Study of Prescribing Pattern for Evaluation of Rational Drug Therapy in WarangalPavani V, Mihir Y.P, Shravani K, Prabhakar R.V ................................................................................................................. 77 - 79Evaluation of the Impact of a Training Module on Patient Counseling for Practising Community PharmacistsRamanath K.V, Nagavi B.G .................................................................................................................................................80 - 84Instructions to Authors

Dear ReadersIndian Journal of Pharmacy PracticeijoppEditorialAt the outset, Heartiest congratulations from the editorial board to Prof. Ganachari, Dr. Mahendra Kumar BJ, Mrs. Shashikala C W & Mr. Fibin M and Dr. Mahendra Kumar B J & Mr. Annfasoddin K for havingbagged the Best Paper award for the articles published in ijopp during the year 2010-2011 in the areas ofClinical Pharmacy (Title: Assessment of Drug Therapy Interventions by Clinical Pharmacist in a TertiaryCare Hospital)and Community Pharmacy (Title: Assessment of medication adherence and knowledge inHIV/AIDS patients in a selected Community Pharmacy) respectively.Some of the problems in drug therapy are inter-individual variations in plasma drug concentration/response and adverse drug reactions. Thus, the concept of drug treatment is changing from 'right drug forthe right person' to 'right dose for the right person'. In other words Individualization of drug therapy is invogue and Clinical Pharmacokinetics is an effective tool to achieve this.When a patient fails to respond to a usual therapeutic dose, measurement of plasma drug concentrationshelps to distinguish between a non-compliant patient and a non-responding patient. Similarly, when thereare adverse drug reactions, measuring the plasma concentration helps to assess whether they are due todrug levels above the toxic range. Then the dosage regimen can be adjusted using the pharmacokineticprinciples.More and more clinicians are now showing interest in this area and seeking clinical pharmacist's expertisein dosage adjustment. So, it is the need of the day for us to strengthen our skills and knowledge inpharmacokinetics.In light of the above, I invite good research articles where dosage adjustment and individualization of thedrug therapy has been carried out with the intervention of the clinical pharmacist.Some of you may have attended the pre-conference workshop on “The Basic Concepts of Scientific Researchand Scientific Communication” and the 63rd Indian Pharmaceutical Congress which were held at nammaBengaluru during December 2011. Hope you had good learning experience and fruitful collaborations.Wishing all our readers a Happy and Prosperous New Year 2012....Dr. Shobha Rani R HiremathEditor-in-Chiefijoppwww.ijopp.org | ijopp@rediffmail.com

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaCombating Antimicrobial Resistance: 2011 is the year of “No action today, No curetomorrow”1 1 2Daxesh M.P , Ganachari M.S , Sunitha C.S*1Department of Pharmacy Practice, KLE University College of Pharmacy, Belgaum, Karnataka2Pharmacy Practice and Administration, Faculty of Pharmacy, Rhodes University, Grahamstown, South AfricaA B S T R A C TSubmitted: 10/10/2011Accepted:9/11/2011The Antibiotic era, which started in the 1940s, changed human demography and the profile of infectious diseases in the world. Despite theadvantages antibiotics had in improving public health across countries, continued irrational use of antimicrobials has resulted in increasinginstances of antimicrobial resistance (AMR). AMR is emerging as a global public health problem resulting in increasing morbidity, mortality andfinancial costs to treat resistant infections. AMR is causing an increased burden on the financial stability of health care systems globally, but hasthe greatest negative impact on developing countries which continue to struggle with weak infrastructures and limited resources – both humanand financial. AMR reduces the effectiveness of available, cost-effective treatments because patients remain infectious for longer and spreadresistant microorganisms to others. Developing countries, societies, families and individual patients continue to bear longer duration of illnessand treatment which increases health-care costs and their financial burden. Due to the increased incidence of resistant microorganisms in bothhospitals and community settings, the antimicrobial resistance crisis is increasing at an alarming rate and is expected to increase at a similar orhigher rate in future as antimicrobial agents continue to become ineffective. Other than irrational use of antibiotics in humans, indiscriminatemisuse of antibiotics in agriculture and animal husbandry is fuelling increased AMR. This critical juncture necessitates professionalism andaccountability towards public health from pharmacists, who can play a crucial role in promoting rational use of antimicrobials and monitoring ofAMR.Keywords: Antimicrobial Resistance, World Health Day, Global Problem, Role of Pharmacist, Cost and consequences, AMR ChallengesAntimicrobials and AMR ChallengesPeople live longer and healthier lives today because ofpowerful and effective medicines such as antimicrobialswhich are available to treat infectious diseases. Prematuredeath from various infectious diseases occurred until the1discovery and availability of antimicrobials in the 1940s.However, the introduction of every antimicrobial agent intoclinical practice has been followed by the detection of strainsof microorganisms that are resistant, i.e. able to multiply inthe presence of drug concentrations higher than the2concentrations in humans receiving therapeutic doses.Antimicrobial resistance (AMR) is the resistance of amicroorganism to an antimicrobial medicine to which it waspreviously sensitive. Resistant organisms (such as bacteria,viruses and some parasites) are able to withstand attack byantimicrobial medicines, such as antibiotics, antivirals, andantimalarials, so that standard treatments become ineffective,Address for Correspondence:Sunitha C S, Pharmacy Practice and Administration, Faculty of Pharmacy,Rhodes University, Grahamstown, South AfricaE-mail: s.srinivas@ru.ac.zaand infections persist and may spread to other people. AMR isa consequence of continued misuse and irrational use ofantimicrobial medicines, allowing microorganisms to mutate3or acquire a resistant gene.Some microorganisms, such as Multidrug-Resistant TB(MDR-TB), Extensively Drug Resistant TB (XDR-TB),Methicillin resistant Staphylococcus aureus, Vancomycinresistant enterococci, Streptococcus pneumoniae and otherpathogens, have developed resistance to clinically usefulantibacterial agents in both developed and developing14countries. AMR is emerging as a global public health15problem with a resulting increase in morbidity and mortality.The 60th World Health Assembly (WHA) in April 2007highlighted the serious problem of the continued overuse andinappropriate use of antibiotics worldwide based on 79216surveys in low and middle income countries. The morbidity,mortality and financial cost of antimicrobial infections posean increasing burden on the financial stability of local,regional and national health care systems globally but havethe greatest impact on developing countries with limitedresources.14, 17Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 2

Daxesh M P - Combating Antimicrobial Resistance: 2011 is the year of “No action today, No cure tomorrowFig. 1: Key facts and figures highlighting the development ofantibiotics and Essential medicines conceptInitial Discovery of Antibiotics and Development of their4ResistanceDiscovery of Antibiotics Clinical Use Resistance IdentifiedPenicillin – 1940 1943 1940Streptomycin – 1944 1947 1947, 1956Tetracycline – 1948 1952 1956Erythromycin – 1952 1955 1956Gentamycin – 1963 1967 1970AMR became an important issue in the 1960s when5resistance plasmid and transmissibility were detected• WHO published the First Model Essential Medicine List in61977• WHO revises its Model Essential Medicine List every 27years8• WHO recognized global AMR threat in 1998• WHO developed the Global Strategy for the containment of2Antimicrobial Resistance in 2001• WHO and member states are observing 2011 as the year ofAntimicrobial resistance : No action today, No cure tomorrow1to building momentum for rational use of antibioticsIndiaŸ First Comprehensive DrugPolicy – 1978[9]Ÿ National Drug Policy –1986[10]Ÿ First Essential MedicineList – 1996[11]Ÿ N a t i o n a l E s s e n t i a lMedicine List – 2011[11]South AfricaŸ First National Drug Policy– 1996[12]Ÿ First Standard TreatmentGuidelines and EssentialMedicine List – 1996[13]Ÿ Standard TreatmentGuidelines and EssentialMedicine List – 2008[13]Some microorganisms, such as Multidrug-Resistant TB(MDR-TB) , Extensively Drug Resistant TB (XDR-TB),Methicillin resistant Staphylococcus aureus, Vancomycinresistant enterococci, Streptococcus pneumoniae and otherpathogens, have developed resistance to clinically usefulantibacterial agents in both developed and developing14countries. AMR is emerging as a global public health15problem with a resulting increase in morbidity and mortality.The 60th World Health Assembly (WHA) in April 2007highlighted the serious problem of the continued overuse andinappropriate use of antibiotics worldwide based on 79216surveys in low and middle income countries. The morbidity,mortality and financial cost of antimicrobial infections posean increasing burden on the financial stability of local,regional and national health care systems globally but havethe greatest impact on developing countries with limited14, 17resources.Health Care Cost of AMRAMR reduces the effectiveness of treatment because patientsremain infectious for longer, thus potentially spreading1resistant microorganisms to others. The application ofeconomics to the problem of antimicrobial resistance extendsbeyond the important point that treatment costs are higher for18, 19, 20infections caused by resistant organisms. The longerduration of illness and treatment, often in hospitals, increaseshealth-care costs as well as the financial burden to families1and societies. The World Health Organization (WHO)estimates that up to 40% of health care costs are related to21procurement of medicines.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 3

Daxesh M P - Combating Antimicrobial Resistance: 2011 is the year of “No action today, No cure tomorrow22Ÿ Infections from resistant bacteria are a serious problem in health care settings, causing life-threatening infections.Ÿ About 440 000 new cases of multidrug-resistant tuberculosis (MDR-TB) emerge annually, causing at least 150 000 deaths1worldwide. XDR-TB has been reported in 64 countries to date. According to a study, the costs of first line and second line23medicines for the treatment of tuberculosis are US$20/course and US$3 500/course respectively and the average cost to treat24MDR-TB is $17 000.Ÿ Every year in the European Union alone, an estimated 25 000 patients die because of a serious resistant bacterial infection22acquired in hospitals. The costs associated with AMR among outpatients in the USA have been estimated to be between23,25US$400 million and US$18.6 billion and the corresponding costs among inpatients are likely to be several times higher. TheCanadian Committee on Antibiotic Resistance developed a model that suggested resistant infections add $14 to $26 million indirect hospitalization costs to health care cost in Canada – about $9 to $14 million more than those infections would have cost,had they been drug susceptible. Additional containment measures, such as patient screening and infection control, added23, 26another $26 million.Ÿ Primary resistance to at least one antiretroviral medicine is 0-25% for the treatment of HIV infection in recent years; surveys are1, 23under way to detect and monitor resistance. The first line and second line treatment costs to treat HIV/AIDS are estimated at23US$482/patient/year and US$6 700/patient/year respectively.Ÿ AMR has become a serious problem, with 5-98% penicillin resistance and 1-50% of fluoroquinolone resistance for the treatment1, 23of gonorrhoea, and is increasing worldwide. Untreatable gonococcal infections would result in increased rates of illness and1death. A Zimbabwean study reported that 90% of gonococci isolates were resistant to trimethoprim+sulphamethoxazole and23, 2716% were resistant to tetracycline.1Ÿ New resistance mechanisms such as the beta-lactamase NDM-1 have emerged among several gram-negative bacilli. A study in28ŸFig. 2: Facts and Figure on AMRIndia, Pakistan and UK found many isolates with NDM-1. This can render powerful antibiotics, which are often the last defence1against multi-resistant strains of bacteria, ineffective.23Chloroquine resistant malaria has affected 81 countries out of 92 countries worldwide. First line treatments are affordable at23, 29approximately US$0.10-0.20/adult course and Second line treatments cost approximately US$1.20-3.50/adult course.Ÿ ·The treatment of pneumonia and bacterial meningitis has been affected due to 0-70% penicillin resistance, 6-43% ampicillin23resistance and 11-72% Macrolide resistance in Streptococcus pneumoniae.Ÿ About 0-70% of hospital-acquired infections are caused by highly resistant bacteria such as methicillin-resistant Staphylococcus1aureus (MRSA) and vancomycin-resistant enterococci. Studies have reported that the total cost of treating MRSA compared to30MSSA is up to three times more expensive.If AMR continues unchecked, many infectious diseases will become uncontrollable and could easily derail progress towards the1health-related United Nations Millennium Development Goals for 2015 and other development goals thereafter.AMR in Hospital and CommunityAntibiotic resistance has a negative impact on the outcome oftherapy and is associated with the increased risk of cross18, 31infections in the hospital and communities wheretransmission of bacteria is greatly amplified within a highlysusceptible population in a confined space. The elderly, veryyoung and chronically ill people are at greater risk of14developing drug resistance infections. With increasingantibiotic use in the community, the greatest concentration ofuse per patient is in hospitals, and hospital pathogens tend tobe the most resistant. Mortality rates and duration of hospitalstay are twice as high for patients infected with resistantbacteria as for those infected with susceptible strains of the31same species. The increase in the incidence of resistantorganisms in both hospitals and community settings is one ofthe reasons for the increase in the antimicrobial resistance32crisis.Consequences of AMRAntimicrobial resistance has been increasing at an alarmingmode in recent years and is expected to increase at a similar orgreater rate in future as antimicrobial agents continue to losetheir effectiveness. Resistant bacteria do not respect nationalor international borders; the development of resistance in themost remote locations can have an impact throughout theworld in a very short time.14 The tendency for antibiotic use topromote the emergence of resistant microorganisms is calledantibiotic pressure, and there are many reports of resistancerising during increased antibiotic use and falling after a31reduction in use.Antimicrobial resistance has struck at the core of infectious33, 34, 35disease control worldwide. Antimicrobial resistance isof particular concern in countries where prescription ofantimicrobial agents is unregulated and where antibiotics areIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 4

Daxesh M P - Combating Antimicrobial Resistance: 2011 is the year of “No action today, No cure tomorrowwidely available Over the Counter. The increased use ofantibiotics in the agriculture and food industries is alsoconsistent with the rise in antimicrobial resistance among33human and animal pathogens. WHO recognizes that the paceof development of new antimicrobial agents has sloweddramatically, that effective vaccines for many importantpathogens will not be available in the near future; and thatfunding for laboratories engaged in basic research inantimicrobial resistance, preventive and therapeuticmodalities, is inadequate.Accumulate the evidence for36action in curbing AMRSurveillance of antimicrobial36resistance and use14Fig 3: Monitoring and Evaluation of AMR – Call for Action:Build alliances and partnershipsto increase access to37antimicrobialsPromote the concept of essentialmedicines and make effectivemedicines available, affordableand accessible, especially to the37poor people36Rational drug use and regulations – eg: To develop measures toencourage appropriate and cost-effective use of antimicrobials; Toprohibit the dispensing of antimicrobials without the prescription ofa qualified healthcare professional; To strengthen legislation toprevent the manufacture, sale and distribution of counterfeitantimicrobials and the sale of antimicrobials on the informal8market36Animal husbandry regulations– eg To reduce the use of37Antimicrobials in LivestockInfection prevention and control36in health-care facilities – Eg:To improve practices to preventthe spread of infection andthereby the spread of resistant8pathogensIncrease research for new37medicines and vaccinesMake effective medicines37available to poor peopleCommitment towards acomprehensive, financednational plan with accountabilityand civil society engagementIncrease resources to curbantibiotic resistance in the4developing worldWHO Resolution and Action Strategies on AMRThe WHO Global Strategy noted that the 1998 WHAResolution had urged Member States to take action andcommit to reducing AMR.[39] In 2001, WHO published theWHO Global Strategy on Containment of AntimicrobialResistance together with a series of recommendations aimedat enabling countries to define and implement nationalpolicies in response to antimicrobial resistance.[2, 38] The2005 WHA Resolution cautioned about the slow progress inaddressing AMR and called for the rational use ofantimicrobial agents by providers and consumers.[38] On 738April 2011, World Health Day, the WHO called for action tohalt the spread of AMR by introducing a six-point policypackage to policy-makers and planners, the public andpatients, practitioners and prescribers, pharmacists anddispensers, and the pharmaceutical industry worldwide.[33,34, 35] Governments have a critical role to play in theprovision of public goods such as information, surveillance,analysis of cost effectiveness and cross-sectoralcoordination.[2] At the same time, these critical challengesopen doors for health care professionals, especiallypharmacists, to proactively adopt strategies in promoting therational use of antibiotics. Professionalism and workingtowards public health requires pharmacists to demonstratetheir role as concerned health care professionals who promoterational use of medicines, including antibiotics.Fig 4: The Role of Pharmacists in Monitoring of AMRTo increase awareness of theAMR problem among the4, 37general publicTo promote rational use ofantimicrobials among health2care workersTo dispense antimicrobialsbased only on valid2prescriptionsTo prevent misuse ofantimicrobials in the hospital as2well as communityTo educate patients and thegeneral community on theappropriate use of2antimicrobialsTo participate in the infectioncontrol programme in hospitalsAmong the interventions mentioned in the WHO Globalstrategy for the containment of AMR, patients prescribed withantimicrobials were identified as the primary interventiongroup for education on appropriate use of antimicrobialsbecause in most developing countries antimicrobials arefreely available without a prescription. Management Sciencefor Health (MSH) in collaboration with United States AgencyInternational Development (USAID) has developed apopulation-based AMR module to quantify knowledge andbehaviour of communities regarding antimicrobial drugs and40AMR.In 1993, the WHO Action Programme on Essential Drugs(WHO/DAP) published the manual How to Investigate DrugUse in Health Facilities in response to increased awareness ofproblems impeding the rational use of medicines (WHO1993). This manual presented 12 indicators for assessingmedicine use in outpatient health facilities, and one of theseindicators records the number of antibiotics prescribed to[41]patients. In 2001, MSH and USAID published the manualHow to Investigate Antimicrobial Use in Hospitals: Selected2Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 5

Daxesh M P - Combating Antimicrobial Resistance: 2011 is the year of “No action today, No cure tomorrowIndicators to field test various objectives such asantimicrobial prescribing practices, comparativeperformance between hospitals or prescribers, monitoringperformance and orienting supervision, and assessing32changes resulting from interventions. Field Trials of hospitalantimicrobial indicators were done in six hospitals in Uganda42and Ghana. A baseline survey on antimicrobial drug use,AMR and its containment has been done in Ethiopia with thesupport of the Drug Administration and Control Authority ofEthiopia in collaboration with Management Sciences for[43]Health. Developing countries such as India and SouthAfrica have to conduct more operational research in thesecritical areas of AMR in order to combat the growing menaceto public health because effective antibiotics are becominguseless due to increased misuse.REFERENCES1. World Health Day 2011. COMBAT ANTIMICROBIALRESISTANCE. No Action Today, No Cure Tomorrow. Availablefrom: www.who.int/world-health-day/2011 Accessed on 18September 2011.2. WHO global strategy for containment of antimicrobialr e s i s t a n c e . 2 0 0 1 A v a i l a b l e f r o m :h t t p : / / w w w . w h o . i n t / d r u g r e s i s t a n c e/WHO_Global_Strategy_English.pdf Accessed on 10September 2011.3. Antimicrobial resistance [online]. Available from:http://www.who.int/ mediacentre/factsheets/fs194/en/Accessed on 12 September 2011.4.. Avorn JL, Barrett JF, Davey PG, et al. AntimicrobialResistance: synthesis of Recommendations of Expert PolicyG r o u p s . 2 0 0 1 . A v a i l a b l e f r o m :http://whqlibdoc.who.int/hq/2001/WHO_CDS_CSR_DRS_2001.10.pdf Accessed on 11 September 2011.5. WHO workshop on containment of antimicrobial resistance inE u r o p e 2 0 0 4 . A v a i l a b l e f r o m :http://www.who.int/drugresistance/infosharing/AMR_WS_WERNIGERODE_REPORT_EURO.pdf Accessed on 15September 2011.6.Ham Rianne van den, Bero L, Laing R. Selection of EssentialMedicines, The World Medicines Situation 2011. Availablefrom: http://apps.who.int/medicinedocs/documents/s18770en/s18770en.pdfAccessed on 9 September 2011.7. WHO. Essential Medicines (Online) Available from:http://www.who.int/mediacentre/factsheets/fs325/en/index.html Accessed on 27 September 2011.8. Fifty-First World Health Assembly. Emerging and othercommunicable diseases: Antimicrobial Resistance. WorldHealth Organization, Geneva 1998 May. Available from:http://apps.who.int/medicinedocs/documents/s16334e/s16334e.pdf Accessed on 2 August 2011.9. National Pharmaceutical Policy, 2006. Available from:http://www.drugscontrol.org/draftNPP2006.pdf Accessed on18 September 2011.10. National Drug Policy for India, 1986. Available from:http://nppaindia.nic.in/drug_pol86/txt1.html Accessed on 29August 2011.11. National List of Essential Medicines of India 2011. Availablefrom: http://cdsco.nic.in/National%20List%20of%20Essential%20Medicine-%20final%20copy.pdf Accessed on27 August 2011.12. National Drug Policy for South Africa 1996. Available from:http://apps.who.int/medicinedocs/documents/s17744en/s17744en.pdf Accessed on 18 August 2011.13. Standard Treatment Guidelines and Essential Medicines List2008, Essential Drug Programme, South Africa. Availablefrom: http://www.kznhealth.gov.za/edlphc2008.pdf Accessedon 9 August 2011.14. WHO Scientific working group on monitoring andmanagement of bacterial resistance to antimicrobial agents1994, Geneva.15. Xiao Y-Hong, Giske CG, Wei Ze-Qing, Shen P, Heddini A, Li L-Juan. Epidemiology and characteristics of antimicrobialresistance in China [Internet]. Drug Resistance Updates.2011: 1-15. Accessed on 3 August 2011.16. Sixtieth World Health Assembly. Progress reports on technicaland health matters. World Health Organization. 2007 April 5.Available from: http://apps.who.int/gb/ebwha/pdf_files/WHA60/A60_28-en.pdf Accessed on 2 August 2011.17. Diazgranados CA, Cardo DM, McGowan JE. Antimicrobialresistance: international control strategies, with a focus onlimited-resource settings. [Internet]. International journal ofantimicrobial agents. 2008 July 32(1): 1-9. Available from:http://www.ncbi.nlm.nih.gov/pubmed/18550343 Accessed on2 August 2011.18. Eggleston K, Zhang R, Zeckhauser RJ. The Global Challengeof Antimicrobial Resistance: Insights from Economic Analysis.International Journal of Environmental Research and PublicHealth. 2010 August 9: 3141-3149.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 6

Daxesh M P - Combating Antimicrobial Resistance: 2011 is the year of “No action today, No cure tomorrow19. Cosgrove SE. The Relationship between AntimicrobialResistance and Patient Outcomes: Mortality, Length ofHospital Stay, and Health Care Costs. Clinical InfectiousDiseases. 2006; 21287(Suppl 2):82-89.20. Coast J, Smith RD, Millar MR. An Economic Perspective onPolicy to Reduce Antimicrobial Resistance. Social Scienceand Medicine. 1998; 46(1): 29-38.21. Kunin CM, Lipton HL, Tupasi T, Sacks T, Scheckler E W,Jivani A, et al. Social, Behavioural, and Practical FactorsAffecting Antibiotic Use Worldwide : Report of Task Force 4.Reviews of Infectious Diseases. 1987 May-June; 9(3): S270-S285. Available from: http://www.jstor.org/stable/4454153Accessed on 25 August 2011.22. WHO European Region (Online) Available from:h t t p : / / w w w. e u r o . w h o . i n t / e n / w h a t - w e - d o / h e a l t h -topics/disease-prevention/antimicrobial-resistance/antibioticresistanceAccessed on 25 August 2011.23. Nelson N, Joshi M, Kirika R. Antimicrobial Resistance: TheNeed for Action in the East, Central and Southern AfricaR e g i o n . 2 0 0 9 . A v a i l a b l e f r o m :http://pdf.usaid.gov/pdf_docs/PNADP643.pdf Accessed on25 August 2011.24. Bartlett JG. The Potential Disaster of Extensively DrugResistance Tuberculosis. Centre for Biosecurity of UPMCClinicians Biosecurity News Analysis of Advances andChallenges in Clinical Biosecurity. 2006 November. Availablef r o m : h t t p : / / w w w . u p m c -cbn.org/report_archive/2006/cbnreport_111006.htmlAccessed on 27 August 2011.25. Okeke IN, Laxminarayan R, Bhutta ZA, Duse AG, Jenkins P,O'Brien TF, et al. Antimicrobial resistance in developingcountries. Part I: recent trends and current status. [Internet].The Lancet infectious diseases. 2005 Aug; 5(8):481-93.Available from: http://www.ncbi.nlm.nih.gov/pubmed/16048717 Accessed on 29 August 2011.26. Canadian Committee on Antibiotic Resistance. Antimicrobialresistance: A Deadly Burden No Country Can Afford to Ignore.Canada Communicable Disease Report. 2003 September;29(18). Accessed on 1 October 2011.27. Mason PR, Gwanzura L, Latif AS, Marowa E, et al.Antimicrobial resistance in gonococci isolated from patientsand from commercial sex workers in Harare, Zimbabwe.International Journal of Antimicrobial Agents. 1998 9; 175-179. Accessed on 1 October 2011.28. Kumarasamy KK, Toleman MA, Walsh TR, Bagaria J, Butt F,Balakrishnan R, et al. Emergence of a new antibioticresistance mechanism in India, Pakistan, and the UK: amolecular, biological, and epidemiological study [Internet].The Lancet Infectious Diseases. 2010 Aug; 597-602. [cited 11A u g 2 0 1 0 ] A v a i l a b l e f r o m :http://linkinghub.elsevier.com/retrieve/pii/S1473309910701432 Accessed on 3 March 2011.29. Yeung S. et al. Antimalarials Drug Resistance, ArtemisininbasedCombination Therapy, and the Contribution ofModeling to Elucidating Policy Choices. The American Societyof Tropical Medicine and Hygiene. 2004; 71 (Suppl. 2): 179-186.30. Dancer SJ 2005. “The Real Cost of MRSA”. In AntibioticPolicies: Theory and Practice. Ed. Gould and van der Meer.Kluwer Academic/Plenum Publishers, New York. Quoted inNelson N, Joshi M, Kirika R. 2009. Antimicrobial Resistance:The Need for Action in the East, Central and Southern AfricaRegion.31. French GL. The continuing crisis in antibiotic resistance[Internet]. International Journal of Antimicrobial Agents. 2010;36S3-S7. Available from: http://dx.doi.org/10.1016/S0924-8579(10)70003-0 Accessed on 4 August 2011.32. World Health Organization (WHO) 2008. How to InvestigateAntimicrobial Use in Hospitals: Selected Indicators. Publishedfor the U.S. Agency for International Development. Availablef r o m : h t t p : / / w w w . m s h . o r g / p r o j e c t s / s p s / S P S -Documents/upload/Indicator-based-Study-on-Hospital-Antimicrobial Use_Manual_Final.pdf Accessed on 4 August2011.33. Hsueh Po-Ren. World Health Day 2011 — AntimicrobialResistance: No Action Today, No Cure Tomorrow [Internet].Journal of the Formosan Medical Association. 2011;1 1 0 ( 4 ) : 2 1 3 - 2 1 4 . A v a i l a b l e f r o m :http://www.sciencedirect.com/science/article/pii/S0929664611600326 Accessed on 4 August 2011.34. WHO. Antimicrobial resistance and its global spread, 2011.Available at: http://www.who.int/world-health-day/en/index.html Accessed on 2 August 2011.35. WHO. WHO urges countries to take measures to combata n t i m i c r o b i a l r e s i s t a n c e , 2 0 1 0 . A v a i l a b l e a t :http://www.who.int/mediacentre/news/releases/2010/amr_20100820/en/ Accessed on 2 August 2011.36. WHO. Combating Antimicrobial Resistance: Experiencesfrom the Field. 2011. Available from: http://www.who.int/worldhealth-day/2011/tested_interventions.pdfAccessed on 4August 2011.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 7

Daxesh M P - Combating Antimicrobial Resistance: 2011 is the year of “No action today, No cure tomorrow37. WHO. Overcoming Antimicrobial Resistance – World HealthReport on Infectious Diseases 2000. Available from:h t t p : / / w w w . w h o . i n t / i n f e c t i o u s - d i s e a s e -report/2000/other_versions/index-rpt2000_text.htmlAccessed on 4 August 2011.38. Leung E, Weil DE, Raviglione M, Nakatani H. The WHO policypackage to combat antimicrobial resistance. Bull World HealthOrgan 2011; 89:390-392.39. WHO. Community-Based Surveillance of Antimicrobial Useand Resistance in Resource-Constrained Settings: Report onFive Pilot Projects. 2009 March. Available from:http://apps.who.int/medicinedocs/documents/s16168e/s16168e.pdf Accessed on 2 March 2011.40. Antimicrobial Resistance Module for Population-BasedSurveys 2008. Published for United States AgencyInternational Development, Management Science for Healtha n d M a c r o I n t e r n a t i o n a l . A v a i l a b l e f r o m :http://www.measuredhs.com/What-We-Do/Survey-Types/upload/AMR_Mod_8_5_8_FINAL.pdf Accessed on 4August 2011.41. WHO, How to investigate drug use in health facilities: Selectedd r u g u s e i n d i c a t o r s . 1 9 9 3 . A v a i l a b l e f r o m :http://apps.who.int/medicinedocs/pdf/s2289e/s2289e.pdfAccessed on 4 August 2011.42. How to investigate antimicrobial drug use in the hospital:selected indicators. Workshop on Local and Regional actionsto Address Antimicrobial Resistance. 2008.43. Antimicrobials Use, Resistance and Containment BaselineSurvey Syntheses of Findings. 2009. Published for Drugadministration and control authority of Ethiopia, USAID, andMSH.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 8

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaIndia's Progress towards the health related Millennium Development Goals - ChildMortality1,2,6 1,2,6 3 4 1,2,5,6Patel I , Chang J* , Srivastava J , Patel I , Balkrishnan R1Clinical, Social and Administrative Sciences, College of Pharmacy, University of Michigan at Ann Arbor, 428 Church Street, Ann Arbor, MI48109-1065, USA2Center for Medication Use, Policy, and Economics, The University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA3E.W. Scripps School of Journalism, Ohio University, 220 Scripps Hall, Athens,OH, 45701-2979, USA4Patel Hospital, Somnath Park, Panchavati, Nasik, Maharashtra 422003, India5Department of Health Management and Policy, The University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA6Center for Global Health, The University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USAA B S T R A C TSubmitted: 16/9/2011Accepted: 2 /11/2011India has seen unprecedented growth in its economy in the past ten years. At the same time, India now carries 1/6th of the world's population andcarries a large portion of the world's poor. The Millennium Development Goals (MDGs) put forth by the United Nations contains severalambitious health goals. With India's current population and health status, it plays an important role in meeting the overall MDGs. This reportintroduces child mortality as the 4th health related MDG, discusses India's past efforts to combat child mortality, the current trends in child health,and recommendations to accelerate progress towards reducing child mortality.Keywords: child mortality, WHO, India, global health, MDGsIntroductionHealth related MDGs:United Nation's millennium development goals (MDG) aimat taking steps to accelerate human development across theglobe. They propose a multidimensional approach focusingon various aspects of development involving economic,social, and environmental factors. These goals were proposedin year 2000, and the targets were set for fifteen year duration,i.e. from 2000 to 2015 1. At the end of around two-third of thatduration, we evaluate the progress made towards healthrelated MDGs in India. India, a developing country with thesecond largest population in the world, has recently seensignificant economic growth and social changes and may, insome ways, be considered a case for evaluating MDGs in fastchanging, multidimensional environments.The health related MDGs are the fourth, fifth, and sixth goalswhich focus on addressing some of the most challenginghealth problems across the world. MDG 4 focuses oncontrolling child mortality rates, MDG 5 focuses on reducingAddress for Correspondence:Chang J, The University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USAE-mail: jochang@umich.edumaternal mortality rates, and MDG 6 aims at controllingincidence and spread of life threatening diseases likeHIV/AIDS, Malaria, and tuberculosis (TB) 2. These healthissues pose different challenges due to the nature of problem.In many cases, other social and economic factors may alsoplay a big role and may make the solution more complex at allstages of MDG initiatives. Due to these complexities, MDGsmake an effort to consider each problem as a unique case withmultifaceted solutions. This essentially implies that owing tothe nature of the problem, the indicators of progress madetowards each goal may be different.In the following sections we review the progress made byIndia towards attainment of the 4th MDG. We first present anoverview of challenges and measures, followed by anevaluation of initiatives and interventions in the past andpresent, followed by a discussion of donor roles and ourrecommendations. A section on donor roles have been addedto discussion of the MDG due to the global nature of MDGattainment efforts. Donor role also gains importance in case ofdeveloping nations because in many cases external financialassistance is required to implement such large scale effortsand unavailability of such resources may prove to be aterminal bottleneck in implementation of initiatives towardsattainment of MDG.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 9

J. Chang - India's Progress towards the health related Millennium Development Goals - Child MortalityChild MortalityMDG 4 aims to reduce the under-five mortality rate (U5MR)by two thirds by 2015. The U5MR is the probability of a childborn in a specific year dying before reaching the age of fiveand Goal 4 aims at reducing it from 125 deaths per thousandlive births in 1988-92 to 42 in 2015 3,4,5,6 . Though Indiamanaged to bring the U5MR down to 74.6 per thousand livebirths in 2005-06, estimates suggest that by 2015, India mightreach U5MR of 70 per thousand, falling considerably short ofthe MDG 4 target of 42 per thousand live births 2. Similarly,considering Infant Mortality Rate (IMR), the number ofinfant deaths in less than a year after birth, trends suggests thatIndia will be able to attain IMR level of about 46 per thousandby 2015, falling short off the target IMR of 26.7 per thousand7. In the following sections, an overview of measures takentowards attaining MDG 4 has been presented which isfollowed by a discussion of major challenges towardsattainment of MDG 4 and recommendations for possiblesolutions.Past measures:India was the first country in the world to launch a FamilyPlanning Program in 1951. Over time the program evolvedinto Reproductive and Child Health program whichcommenced in October 1997. The goals of the Reproductiveand Child Health program were to stabilize the population,reduce maternal and child mortality and morbidity andimprove their nutritional status. To this end, the programoffered several interventions to improve children healthwhich included a Universal Immunization Program, EssentialNewborn Care and Integrated Management of Neonatal andChildhood Illnesses (IMNCI) program. Due to theseinterventions, decline in the under-five mortality rate hastaken place throughout India and a more noticeable decline isseen in rural areas compared to urban areas. This trendimplies that the government's Universal Immunization andIMNCI programs are being successfully implementedthroughout the rural parts of India.Fig.1: Trend in Measles immunization in 1 year old children8(1990-2008)Present measures:9One-fifth of the world's children live in India. Therefore thecountry's ability to achieve goal 4 is very important to thegrowth and stabilization of the world's children population.There are three indicators measured in order to determine thereduction in under-five mortality rate: under-five mortalityrate, infant mortality rate, and proportion of 1 year oldchildren immunized against measles.In order to successfully reach this goal, the Indian governmentsigned a five-year action plan with UNICEF to promote thesurvival and well-being of its children. In August 2008,India's Minister of State for Woman and Child Developmentand UNICEF India launched the GOI-UNICEF Program ofCo-operation 2008-2012. The joint initiative is designed tohelp India achieve its national development goals while10ensuring that no child is left behind as India moves forward .The joint plan focuses on the reduction of India's infantmortality and maternal mortality rates (IMR and MMR),fighting malnutrition, tackling HIV, providing qualityeducation, ensuring safe water and environmental sanitationand providing child protection. This partnership seeks topromote the well-being and survival of India's children.Fig. 2: IMR and U5MR over the last 2 decades8(1990, 1995, 2000, 2005, 2008)The program wants to further reduce IMR from 58 to 28 per1,000 live births, and MMR from 301 to 100 per 100,000 livebirths within five years. The main interventions will focus onimproving access to immunizations, child survival andmaternal care and strengthening the current health care11infrastructure.In addition to this initiative, there are other initiativesunderway in India which seeks to help the country reach itsMDG-4 by 2015. The Child Environment program aims toimprove the availability of clean or safe water availability, itsmanagement, conservation and equitable allocation, as wellas access to sanitation and adoption of critical hygienepractices. Through this program the India's government hopesto create sustainable access to safe water and basic sanitationservices. The Children and AIDS program aims to decreaseIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 10

J. Chang - India's Progress towards the health related Millennium Development Goals - Child Mortalitythe rate of new infections and mitigate the impact of HIV andAIDS among children 0-18 years old. This program providesa comprehensive package of services to prevent mother-tochildtransmission of HIV to most HIV-positive pregnantwomen, appropriate care and treatment to HIV-positiveinfants. Additionally, the Social Policy, Planning, Monitoringand Evaluation program is working to improve data collectionand analysis systems in order to disseminate information tosupport evidence-based program planning and advocacy.Furthermore, the Advocacy and Partnerships program isbuilding a voice for children through parliament, civil societyorganizations, media, celebrities and sports endorsements12,13and campaigns to ensure children's rights.Another program implemented in India is the ChildDevelopment and Nutrition program which focus onimproving the nutritional status of the mother and child, bypromoting breastfeeding, appropriate complementary foodsand feeding practices, micronutrient nutrition the control ofanemia and the care of children with severe malnutrition.Anticipated results include the reduction in the level ofmalnutrition, significant reduction in micronutrientdeficiencies and prevention of malnutrition in children belowthree years. Malnutrition accounts for nearly 50% of childdeaths in India. Effective measures such as exclusivebreastfeeding for the first six months of life can significantly14decrease the IMR for India .Fig. 3: Prevalence and severity of underweight children in8India (1993, 1999, 2005)Donor role:More support is needed to scale up the country's responses tothe preventable burden of child mortality. Bilateralarrangements between nations have enormous power togalvanize policy and action. These partnerships should notdepend on money alone and can be sustained by mutual trustand respect between nation-states. Multilateral institutions,meanwhile, set norms and standards, support developmentand humanitarian efforts, and act as neutral evaluators of datacollection and presentation. They act as a moral compassagainst which national policies can be measured. Academiaalso has a part to play—and a neglected part at that—inensuring the independent validity and robustness of countrydata. As experts sitting outside formal intergovernmentalnetworks, scientists have autonomy of analysis andinterpretation that enables them to create and implement aproper accountability mechanism for policymakers 15,16.The collective work of multilateral agencies, individualnation-states, and transnational expert alliances will beessential in creating the conditions for a decade of globalaction on child health.Major Challenges and Recommendations:Targeted interventions: The lack of progress towardsattainment of MDG 4 may be contributed to various factorsbut most clearly visible among them are the U5MR disparitiesacross states, urban/rural populations, maternal education,wealth, religion, caste, and tribe 2, 17. Though some smallerstates in India have showed remarkable progress, most of thebig states are far behind. For example, the U5MR for state ofKerala is 14 deaths per thousand live births whereas for largerstates like Madhya Pradesh and Uttar Pradesh, the U5MR is92 and 91 per thousand live births respectively. The U5MRamong the poorest (101/thousand live births) is around threetimes than the U5MR among the richest (34/thousand livebirths), the U5MR among schedule caste and schedule tribepopulations is the lowest among all caste/tribe basedcategories, and U5MR for children born to uneducatedmothers (95/thousand live births) is more than three timesthan U5MR for children born to highly educated mothers withmore than 12 years of education (30/thousand live births).These indicate towards various geographical andsocioeconomic factors creating a divide among Indianpopulation where one section of population is already wellahead of the U5MR goals set for 2015, whereas the othersection is abysmally behind 17. One of the keyrecommendations in such situations would be to prioritize theefforts and interventions by targeting populations with thehighest U5MR rates.Modify strategies to address neonatal conditions: Some of themajor factors responsible for child deaths are pneumonia,measles, diarrhoea, malaria, and neonatal conditions 17.Under five and infant mortality due to pneumonia, measles,diarrhea and malaria have been reduced through interventionssuch as immunization and oral dehydration therapy whichhave helped in saving the lives of millions of children 18 .However, a lot more can be done to address child mortalitydue to neonatal conditions. According to a study byHouweling et al. (2010) 19, 21% of under five deaths in theworld occur in India out of which, 54% are due to neonatalconditions. Neonatal mortality requires a different set ofinterventions that address the intra-partum period andIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 11

J. Chang - India's Progress towards the health related Millennium Development Goals - Child Mortalityimmediate post–partum period, not addressed by traditionalchild-health programs. As newborn health is inseparable frommaternal health, it is important to recognize that maternalhealth problems not only cause maternal morbidity and deathbut may also lead to fetal compromise, birth asphyxia andneonatal morbidity and mortality 20. Solving the problems ofnewborns will be impossible without thinking about thecontinuum of care from mother to child 21 22. The newstrategy of viewing child health holistically through theIntegrated Management of Neonatal and Childhood Illnesses(IMNCI) is a step in the right direction. It aims to develop aholistic approach towards development and execution ofpreventive and curistic interventions at three level 23,24,25.These three levels are health worker, health service, andcommunity. At the level of the health worker, IMNCI focuseson developing better case management skills, at the level ofhealth services, it focuses on improvement of the overallsystem, and at the community level, it aims to improve thepractices among communities and families to addressneonatal care and related conditions. Due to the highinfluence social factors like normative beliefs, stigmas, andextra medical practices hold in Indian health environments,IMNCI might be a more effective solution due to its emphasison community level engagement.CONCLUSIONIn the past 15 years, India has encountered multiple hurdles toachieving the health-related MDGs. Structural and culturalissues including inefficient and inadequate health systems,inadequate social support, and a general lack of healthawareness remain prevalent. Government action andcommunity involvement must play integral roles in rampingup efforts to meet the MDGs. Given India's disproportionateburden of MDG-related health issues, it carries a largeresponsibility to tackle these problems quickly andeffectively. Government leaders, donors, and communityleaders must recognize these facts and cooperate to findsustainable solutions.REFERENCES:1. Central Statistical Organization (2005). MillenniumDevelopment Goals - India Country Report 2005.Government of India. Available at: http://www.mospi.nic.in[accessed 18th March 2011.2. Central Statistical Organization (2009). MillenniumDevelopment Goals- India Country Report 2009. Mid-TermStatistical Appraisal. Government of India. Available at:http://www.mospi.nic.in [accessed 20thApril 2011]3. United Nations (2008) The Millennium Development GoalsReport, 2008 United Nations Department of Economic andSocial Affairs. New York, 2008s.4. Wada Na Todo Abhiyan (2007). Measuring India's Progress onthe Millennium Development Goals. 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Agarwal SP (2005) Towards achieving millenniumdevelopment goals in the health sector in India. Journal, IndianAcademy of Clinical Medicine 6(4), 268 -274.10. UNICEF (2008). Tracking progress in maternal, newborn &child survival: the 2008 report. New York. Available at:http://www.who.int/pmnch/Countdownto2015FINALREPORT- apr7.pdf. [accessed on20th April 2011].11. UNICEF (2009) Maternal and Perinatal Deaths Inquiry andResponses. India Country Office, New Delhi. Available at:h t t p : / / w w w . u n i c e f . o r g / i n d i a / M A P E D I R -Maternal_and_Perinatal_Death _Inquiry_and_Response-India.pdf. [accessed on 20th April 2011]12. MOHFW (2006) Child Health Programme in India - Majormilestones in Child Health. Ministry of Health & Family Welfare(MOHFW). Government of India. Available at:http://mohfw.nic.in/dofwwebsite/childhealthrti.pdf. [accessedon 20th April 2011].13. MOHFW (2006) Family Welfare Statistics in India - 2006.National Rural Health Mission. Ministry of Health and FamilyW e l f a r e , G o v e r n m e n t o f I n d i a . A v a i l a b l e a t :h t t p : / / m o h f w. n i c . i n / d o f w % 2 0 w e b s i t e / f w s i i % 2 0 -%202006/book.htm [accessed on 20th April 2010].14. Murray CJ and Lopez AD (1996) The global burden of disease:A comprehensive assessment of mortality and disability fromdiseases injures and risk factors in 1990 and projected to2020. WHO: GenevaIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 12

J. Chang - India's Progress towards the health related Millennium Development Goals - Child Mortality15. WHO (2003) Department of Child and Adolescent Health andDevelopment (CAH), Ministry of Health & Family Welfare(MOHFW). Government of India. Student's handbook forIntegrated management of neonatal and childhood illness.Available at: http://www.whoindia.org/LinkFiles/Child_&_Adolescent_Health_IMNCI__Student_Manual___June_03__%282%29.pdf [accessed on 20th April 2011].16. WHO (2008). Child and Adolescent Health and DevelopmentProgress Report 2006-2007. WHO: Geneva. Available at:http://whqlibdoc.who.int/publications/2008/9789241596497_eng.pdf [accessed on 10th May 2011].17. Wada Na Todo Abhiyan (2010). Millennium DevelopmentGoals in India,2010- A Civic Society Report. Available at:http://asiapacific.endpoverty2015.org/files/mdgs-reportfinaal.pdf.[accessed on 10th May 2011]. 18. Bhargava SK(2004) The challenge of neonatal mortality in India. IndianPediatrics; 41,657-66219. Houweling T, Tripathy P and Nair N, et.al. (2010) Cause-ofdeathdata to support MDG 4 progress . The Lancet376(9743), 770 – 771.20. World Bank (1993). World development report 1993: Investingin Health. Oxford University Press: New York. Available at:http://files.dcp2.org/pdf/WorldDevelopmentReport1993.pdf.[accessed10th May 2011].21. Black RE, Cousens S and Johnson HL, et al.(2010) Global,regional, and national causes of child mortality in 2008: asystematic analysis. Lancet 375,1969-1987.22. Lahariya C (2009) Cash incentives for Institutional delivery:Linking with antenatal and post natal care may ensurecontinuum of care in India. Indian Journal of CommunityMedicine 34,15-18.23. Ingle GK and Malhotra C (2007) Integrated management ofneonatal and childhood illness: An overview. Indian Journal ofCommunity Medicine 32,108-110.24. Chaturvedi SK and Chaturvedi K (2006). Adaptation of theIntegrated Management of Newborn and Childhood Illness( I M N C I ) S t r a t e g y f o r I n d i a . A v a i l a b l e a t :http://www.publichealth.pitt.edu/supercourse/SupercoursePPT/20011-21001/20421.ppt. [accessed on10th May 2011].25. WHO (1997). Division of Child Health and Development.Improving Child health, the integrated approach. Available at:http://whqlibdoc.who.int/hq/1997/WHO_CHD_97.12_Rev.2.pdf [accessed on 21st April 2011].Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 13

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaPoison Information Center-An Overview of its Significance, Organization and FunctioningShobha C*, Ramesh M, Parthasarathi G.Department of Pharmacy Practice, JSS College of Pharmacy, JSS University, SS Nagar, Mysore-15A B S T R A C TSubmitted: 2/10/2011Accepted: 6/11/2011Poisoning is a significant global public health problem. According to world health organization (WHO), in the year 2004, it is estimated that346,000 people died worldwide from unintentional poisoning. Nearly a million people die each year as a result of suicide, and chemicals accountfor a significant number of these deaths. It is estimated that deliberate ingestion of pesticides causes 370,000 deaths each year. In India, thereare higher incidences of poisoning and is also one of the major causes of death. In developing countries, pesticides are frequently used forsuicidal poisoning. Increased mortality and morbidity could have been due to lack of access to information to the physician treating the poisonedpatients and awareness about the prevention, first aid measures and management of different poisoning cases. Poison information center (PIC)can play a vital role in the prevention and management of poisoning cases through provision of information to general public and also tohealthcare professionals. Poison information center or poison control center (PCC) is a specialised unit that provides information on poisoningmanagement and immediate information on early diagnosis, treatment, management, prevention and hazards management of poisoningthrough well trained poison information specialist. Poison information services (PISs) helps in reducing the poisoning treatment cost to thepatients and to public health care facility by preventing the unnecessary visits to the healthcare facilityand prolonged hospitalization. Since therehas been a limited number of PIC to provide the vital service of poison management in India, there is a need for establishing several such centerswith well equipped and well trained personnel is helpful.Keywords: Poison information center, Poison control center, Incidence, India, Poison information servicesINTRODUCTIONPoison information center (PIC) or poison control center(PCC) is a specialised unit that provides information onpoisoning management and immediate information on earlydiagnosis, treatment, management, prevention and hazardsmanagement of poisoning through well trained poison1information specialist. Poison information (PI) is aspecialized area of drug information which refers to theinformation about the toxic effects of chemicals, hazardousmaterial spills, house hold products, over dose of therapeuticmedicines, plants including mushroom, animal toxins bybites of snake, spider and other venomous creatures and2stings.PIC provides poison information services for the effectivemanagement of poisoning cases. Poison information services(PISs) mainly deals with a timely provision of poisoningmanagement information appropriate to the needs of the1,3enquirer. Poison information service also deals with the riskassessment, diagnosis, management and prevention ofAddress for Correspondence:Shobha Churi, Assistant Professor, Department of Pharmacy Practice, JSSCollege of Pharmacy, JSS University, SS Nagar Mysore-15E-mail: shobha912@yahoo.comexposure to any poison, in patients of any age irrespective oftype (intentional or accidental) and route of exposure. Theprimary aim of PIC is to reduce the morbidity and mortalitydue to poisoning and improve the patients' health related2,4quality of life. PISs helps in reducing the poisoningtreatment cost to the patients and to public health care facilityby preventing the unnecessary visits to the healthcare facility,5hospital admission and prolonged hospitalization.PIC functions 24 hours a day round the year with an objectiveof continually improving the outcome of the affected peopleby providing a timely, safe information service appropriate tothe needs of the enquirer related to poisoning, suspected6poisoning and prevention of poisoning. Poison informationcenter aims to prevent unnecessary visits to doctors andhospitals and to ensure that patients, who are poisoned,receive the most effective treatment promptly. The size of thePIC may vary based on call volumes and ideally be locatedadjacent to emergency department. PIC may operate locallyproviding the services to populations of specific geographicallocation or may extend its service to regional / national level.Need for Poison Information CenterPoisoning is a significant global public health problem.According to world health organization (WHO) data, in theIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 14

Shobha C - Poison Information Center-An Overview of its Significance, Organization and Functioningyear 2004 an estimated 346,000 people died worldwide fromunintentional poisoning. Of these deaths, 91% occurred in7low- and middle-income countries . Nearly a million peopledie each year as a result of suicide, and chemicals account fora significant number of these deaths. It is estimated thatdeliberate ingestion of pesticides causes 370,000 deaths each7year. In developing countries, pesticides are frequently usedfor suicidal poisoning. Snake bite is a largely unrecognizedpublic health problem and it has been estimated that about 2.5million people are envenomed every year. Snake bite was thecause for at least 100,000 deaths and around three times as7many amputations and other permanent disabilities.The incidences of poisoning are high and it is one of the major8causes of death in India. Poisoning cases are treated atdifferent levels of health care facility including governmentand private settings. However, owing to lack of poisoninformation services, management of acute poisoning cases isa difficult task to physicians working in emergency9departments of Indian hospitals. Increased mortality andmorbidity could be due to lack of access to information to thephysician treating the poisoned patients and awareness aboutthe prevention, first aid measures and management ofdifferent poisoning cases. Poison information centers (PIC)can play a vital role in the prevention and management ofpoisoning cases through provision of information to general9-11public and also to healthcare professionals. Also there is aincrease in the number of chemicals, household products andmedicines of different brands in the market day by day.Consequently increase of the misuse of these products,leading to increased intentional and unintentional poisoning.The impact of poison information center and its services onquality of health care is very significant and hence there is anincreased need of the PIC to control the morbidity and2mortality due to poisoning.Evolution of Poison Information CenterIncreased number of medicines and chemicals were availablein the market after second world war. Consequent to thishigher incidence of intentional and unintentional poisoningwere observed. But health care professionals were havinglittle knowledge about the ingredients present in the newproducts. In view of the increasing incidence of poisoning andlack of awareness in public about effect of poisoning, thepoison information services were started in 1949 in12,6Netherlands and latter in London. In USA in 1930'spharmacist Louis Gdalman started a poison information6service at St Luke's hospital. Because of Gdalman'sspecialisation in pharmacy and chemistry, physicians all overthe country used to call him for assistance. In late 1940's hestarted recording information on small cards and laterdeveloped a data collection form. In 1950's he established anextensive library on the management of acute and chronicpoisoning and in 1953 the poison information centre atPresbyterian -St Luke's hospital, Chicago was formally6recognised. Subsequently similar centers started6functioning in different parts of the world. All the centers areproviding / have provided invaluable service by creatingpublic awareness on poisoning and providing toxicologicaldiagnostic and therapeutic assistance to health careprofessionals.Poison Information Centers in IndiaIn India, there are only four WHO recognised centersestablished till date. In addition there are few other centersthat offer the poison information through clinical pharmacyservice. First National Poison Information Center wasestablished in February 1995 at the All India Institute of1Medical Sciences (AIIMS), New Delhi. The other centerswere subsequently established at the National Institute ofOccupational Health, Ahmedabad, Government GeneralHospital, Chennai and Amrita Institute of Medical Sciencesand Research, Cochin. Considering the incidence rate ofpoisoning cases in India, these centers may not be able to meetthe demand for poison information. Hence there is a need forwell equipped poison information centers with well trainedpersonnel.Significance of Poison Information CenterThe ultimate motive of PIC is to prevent poisoning deaths dueto accidental, intentional ingestion of poison in general9public. Poison information center aims to assist generalpublic and healthcare professionals with poison preventionand management (identification / assessing / availability ofantidote and management) by providing immediate poison9,2information. Poison information center conductseducational programs to healthcare professionals and publichighlighting the services of poison information centerespecially the identification of poisoning substance, first aid2measures, management and prevention of poisoning cases.It can involve in developing strategy and responding tochemical disasters in association with other responsibleorganisations. There are benefits to the public and healthcareprofessionals by the services provided by the PIC. It ensuresthe health care benefits by reducing morbidity and mortalityfrom poisoning and cost effective benefit by avoidingunnecessary visits to hospital in mild or less severepoisonings. Healthcare professionals get up-to-date andrelevant information about poisoning management. The rolesof PIC are given in Table1.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 15

Shobha C - Poison Information Center-An Overview of its Significance, Organization and FunctioningOrganisation of Poison Information CenterThe organisation pattern of PIC should be based onanticipated 'ideal human exposure call volume'. Majority ofPICs are situated in the hospital and connected to the public13health service of the country at national or regional level.Networking with all other existing PICs that are integratedwith regional PICs and national PIC in for better utilization ofavailable resources and developing national database on13,14poisoning. It is also important to have analyticallaboratories to provide analytical services for themanagement of poisoned patients. Financial support is alsoessential to operate PIC effectively. The government shouldcommit its resources and offer for financial support to PICs,as it is concerned with public health. The centre can alsoremain independent and autonomous by generating its ownrevenue.Staff:Table 1: Roles of poison information centerRoles of poison information centerProvision of poison information servicesManagement of poisoning casesToxicological analytical servicesToxicovigilanceConducting education and training of healthcare professionalsConducting education and awareness program for publicregarding prevention of accidental poisoningDevelopment of treatment protocols for poison managementThe PIC is usually staffed by a physician (Medical director), apharmacist (Technical director), an administrator, at least onemedical toxicologist, adequate number of poison informationspecialists and a secretary. Poison information specialist maybe a pharmacist/nurse/medical scientist. The poisoninformation specialist must be health care professionals inorder to interact freely with physicians while providingconsultative services and interpret basic toxicologyinformation. Pharmacist's educational, and backgroundknowledge about pharmacology, drug products,pharmacokinetics, drug interactions, adverse drug reactions,therapeutic drug use and clinical experience place them in aunique position to contribute in poison information services.The integration of knowledge with the skills of informationretrieval, drug information evaluation, patient history takingand communication skills has been a strong asset topharmacist to perform as poison information specialist.The responsibility of medical and technical directors is topromote research, raise funds, and undertake the furtherdevelopment of the information service. The medicalfunctions of the centre must be the responsibility of a medicaltoxicologist. The poison information specialists should betrained properly to carry out the basic functions of the centre.Responsibilities of the poison information specialist include;the provision of poison information, preparation of standardprotocols, maintain accurate record of all queries, participatein continuing education, update and maintain informationresources and to carry out research activities.It is also desirable to have an administrative director, who isresponsible for the financial, administrative, and other nonmedicalaspects of the centre. In addition, it is better to havepart-time medical toxicologists, poison informationspecialists, and administrative and support staff for smoothand round the clock functioning of the centre. Poisoninformation center also needs advisors in various medical andnon medical fields like botany, zoology, mycology, statisticsand other areas of information management.Location:The feasible location for PIC is within the hospital or a placeclosely associated with the hospital, which has emergency13and intensive care services . Such a setup will provide readyaccess to a network of medical disciplines that will supportand enhance the work of the centre.Facilities and equipment:PIC should be placed in a spacious room with minimum of200 sq ft or working area with basic furniture for staff. Thelibrary should be well equipped with book shelves and filingcabinets for storage of case records and documentation filesfor systemic collection and easy retrieval of the data. Alockable cabinet should also be available to store confidentialdata. Poison information center should be equipped properlywith equipments for communication and to carry out the13functions of centre effectively. Minimum two telephoneswith toll free number are to be reserved to receive the queries.It is essential to have fast and reliable communicationequipment facility such as fax and e-mail. The PIC should tobe equipped adequately with computer, printer andphotocopying machine. For toxicological screening servicesPIC should have laboratory which carries out toxicologicalanalysis.Information resources:Poison information resources are of different types including15primary, secondary, tertiary resources. It is essential to haveall type of resources to provide information. Poisoninformation specialist should have searching and evaluationskills in all type of resources to provide correct and relevantinformation. In tertiary resources the standard textbooks ofIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 16

Shobha C - Poison Information Center-An Overview of its Significance, Organization and Functioningmedicine (general and pediatric), chemistry, pharmacology,analytical toxicology and animal and plant toxins of theregion and standard medical dictionaries are essential. List ofthe medicines, agricultural and other chemical products andtheir ingredients available in the local market and also thelocal pharmacopoeia should also be present. Secondarysources such as Poisindex, Hypertox, Intox and Toxinz aremust for the retrieval of quick and updated information. Manyof the countries have their own databases for the productsavailable in their region. However, the countries which do nothave such databases can select the specific and relevantdatabase which fulfills their needs. Many databases areavailable both on line and on compact disc format (CD-ROM). Primary resources include journals of medicine andtoxicology, for the updated and recent advances in a particulararea. Apart from these resources it is important to developeducational material such as posters on the safe use ofpesticides and chemicals, booklets and leaflets on safe storageof medicines and house hold products at home, and thetreatment protocols of the most common type of poisoning for16clinicians. The list of tertiary, secondary and primaryresources are given in Table 2, 3 and 4 respectively.Table 2: Minimum tertiary poison information resources requiredSl.No Title1 Lindsay Murray, Frank Dary,Mark Little, MikesCadogan, editors. Toxicology handbook. Australia:Churchils Livingstone,Elsevier;20072 Richard C drat, Katherine, M.Hurlbut, Edwin, K, Kuffur,Luke yip.The 5 minute toxicology consult.,currentedition. Philidelphia:Lippincott Williams and wilkins.3 Timothy B,Erickson,William R.Athrens,Steven.E.AK,cart K.Baun,Louis J.Ling. editors.Pediatric toxicology diagnosis and management of thepoisoned child. USA. Mcgraw-Hill; 2005.4 Kent R.Olson,editor.Poisoning and drug overdose.Mcgraw –Hill companies.2004.5 Oserhoudt, perrone, Derros,Henvetic,editor.Toxicologypearls: Philidelphia. Hanley & Belfus.20046 Ellenhorn MJ,Schonwald S, Ordog G,WasserbergJ,editors.Elenhorns medical toxicology diagnosis andtreatment of human poisoning currentedition,Baltimore:Williams and Wilkins;20067 Baselt RC, Cravey RH. Disposition of toxic drugs andchemicals in man, 4th ed. Foster City, CA, ChemicalToxicology Institute, 1995.8 Indian pharmacopoeia9 United states of pharmacopoeia10 British national formularyTable 3: Minimum secondary poison information resources requiredSl.No Title1 Poisindex2 Hypertox3 Toxbase4 Intox5 ToxinzTable 4: Minimum primary poison information resources requiredSl.No Title1 On-line journal scanning services, eg AMEDEO,Current Awareness in Clinical Toxicology2 Clinical toxicology3 Indian Journal of Toxicology4 Indian Journal of Environment & toxicologyFunctioning of Poison Information CenterLegal and ethical prerequisites:Poison information center should be officially recognised bygovernment authorities and ideally by WHO. To carry out thefunctions effectively, the centre should have independentstatus, stability and neutrality. A centre may also have agoverning body to provide policy guidance and assist in fundraising. However the governing body should not involve itselfin the daily activities of the centre. According to legalrequirement, the centre should maintain confidentiality of thedata it handles. Usually the centre should provide theinformation free of cost to enquirers.Policies and procedures:For the effective functioning of the center, it should have welldefined and need based policies and procedures. The policiesand procedures may vary from one center to anotherdepending on scope of service, financial support and center'srequirements. Considering all factors PIC should developpolicies for personnel, method of operation, documentationof service and quality assurance program, staff training,14,15confidentiality, ethical and legal aspects. Policiespertaining to personnel should indicate the mode ofrecruitment of personnel, qualifications and training requiredif any, position of staff with distinct responsibilities. Methodof operation should majorly comprise of handling ofpoisoning cases starting from receipt of query till thedocumentation. A detailed policies and procedures are to beestablished with respect to quality assurance program andquality improvement strategies. Similarly the guidelines forstaff training and confidentiality are crucial.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 17

Shobha C - Poison Information Center-An Overview of its Significance, Organization and FunctioningTraining of staff:Adequate training to PIC staff is essential especially for14,15newly recruited and inexperienced staff. PIC shoulddevelop and implement need based staff training manual. Thiswould enable the PIC to train the new and inexperienced staffof PIC in various areas and ensure that the uniformity in stafftraining is maintained. Training components may includeupdation of knowledge in clinical toxicology, communicationskills, handling of databases, retrieval of information,interpretation & analytical skills, handling of equipmentssuch as computers, telephones and other instruments.Handling of poison information query:The ultimate responsibility of the poison informationspecialist is handling the poison information query. To handlethe query, poison information specialist should have goodskills in communicating clearly and concisely to presentexplanatory or interpretive information. It is necessary toestablish and maintain effective working relationships withother employees of organisations and public in emergencyand other situations. Poison information specialist shouldadopt the skill of reacting calmly and effectively inemergency and stressful situation.Identifying those exposures that are potentially serious andrequire immediate medical assessment and those thatrepresent a minimal risk of toxicity can greatly aid in effectivemanagement of poisoning. By identifying exposures thatrepresent a minimal risk of toxicity, unnecessarypresentations to doctors and hospital emergency departmentscan be avoided. Poison information specialist must assesseach call carefully by listening to the caller and asking openendedquestions. Often the information provided by the calleris insufficient to give an accurate answer; in such cases furthertargeted questions should be asked. The poison informationspecialist taking the call must make a decision based on theinformation given by the caller, an assessment of thereliability of the history, their own clinical judgment and theinformation retrieved from the available sources. If anycomplicated query for which information is not available orthe enquirer is not satisfied with the information provided,then poison information specialist should contact/transfer thecall either to the manager/ director or consultant clinicaltoxicologist and seek their expert advice. Following are thesteps to approach poison information query.Step 1: Receive and obtain requester's demographics:Receive and accept the query related to the service either overphone or in person. Establish the identity of the enquirer bygathering contact details. Also obtain all required informationfrom requester that will help to reply the query. If the enquireris a healthcare professional, the position and anticipatedknowledge of the enquirer should be determined. In caseswhere it takes time to obtain information, ask the enquirer tocall back or note their contact number. Query related topotentially serious poisoning cases need to be answeredimmediately and for a query with minimal toxicityappropriate deadline for a response should be established.Step 2: Collect background information:It is important to collect all the required backgroundinformation to provide appropriate information. Obtainingrelevant information often requires targeted questioning, andadditional care is necessary to accurately identify thepoisoning substance. However, all critical information shouldbe obtained in short time to maximize the patient outcome asotherwise it may be counter productive. Basic informationthat required to be obtained include age and/or weight ofvictim, substance/ product name, route of contact (ingestion,inhaled, dermal, ocular), quantity and/or strength involved,time since exposure, patient's condition (signs, symptomsetc.), treatment received and health status of patient includingmedication history, allergies, relevant pre-existingconditions.Step 3: Assessment of the condition:Appropriate background information allows in understandingthe actual query to be responded. Firstly, the urgency of thesituation is to be assessed in terms of whether the condition isan emergency, serious, not serious or no problem. Assess thelikelihood of toxicity associated with the exposed toxinsbased on the nature of substance, type of exposure andquantity consumed. Assessment of signs and symptoms oftoxicity and analytical testing of compound may greatly aid indetermining the appropriate patient management whetherfirst aid, observation, medical treatment, home treatment orno treatment required for that particular condition.Step 4: Develop and conduct a search strategySelect and prioritise the information resources based onprobability of locating the desired information. It is ideal tolocate the information based on the probable efficiency ofinformation sources in the literature hierarchy. Although inmany instances the information can be provided with the useof tertiary resource, it is worthwhile to consider the otherinformation sources as appropriate. Searching informationfrom databases like Poisindex, Hypertox and Intox mayenable the poison information specialist in retrieving thecomprehensive information in short time. In addition, use ofdeveloped poison management protocols may serve as aready reference especially in emergency situation. Theinformation resources used should be documented on thebasis of its usefulness in responding to a query.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 18

Shobha C - Poison Information Center-An Overview of its Significance, Organization and FunctioningStep 5: Evaluate and provide the information:The retrieved information should thoroughly and critically beevaluated. Comprehensive information has to be generated toensure the recommended line of management is based on allof the current evidence available. Response should begenerated only after critically evaluating all the informationavailable. However, the consistency of information amongthe resources used should be ensured. Interpretation ofinformation available in various resources should be patientspecific and is made considering all other factors. In case oflack of information or conflict of information in the availablesources, a decision may be taken based on professionalknowledge and previous experience. Information may beprovided either verbally/written/printed form/through fax ore-mail as appropriate. However, timely or immediate deliveryof response is critical. In cases where more time is required toevaluate and formulate the response, minimum vitalinformation is to be provided at the earliest possible time.Step 6: Conduct follow-up:Follow up of case is vital so as to assess the patient outcomeand also to ensure whether provision of any additionalinformation is useful in the management of poisoning.Personal visit may be more useful and is possible only whenthe victim is admitted to the hospital where poisoninformation center exist. In other cases the follow up can bemade through other modes including telephone enquiry and e-mail.Step 7: Document:Document the details of enquirer, query and response in atleast any one modes of documentation (paper, computer, logbook etc) is essential for several reasons. It not only helps inthe future reference for similar repetitive query, but alsojustifies the professional value and acts as protective measureagainst legal liability.Step 8: Maintain confidentiality:All issues relating to query is to be kept confidential by thecenter for the socio-legal reasons. The details of the enquirershould not be disclosed to any one including family membersand health care professionals without the consent of theenquirer.Quality assurance:Quality assurance programmes are essential for the PIC. Aformalized quality assurance programme has to be developedand implemented continually in PIC for the services provided6. The aim of implementing the quality assurance program isto improve the quality of service provided and therebyimprove the patient health outcomes. The quality assuranceprogramme should include performance indicators andevaluation methods for monitoring the quality,appropriateness, timeliness of management or treatmentrecommendation and effectiveness of service. In addition tothese, it also helps in resolving identified problems toimprove patient care in a timely manner. Governing body ofthe PIC should conduct meetings at regular intervals todiscuss and take decision on corrective actions and qualityimprovement strategies regarding complicated enquires/cases, any complaints to PIC, statistics of hospitalised poisoncases, review of management protocols, educationalactivities and prevention of poison cases. As part of qualityimprovement programs, expert opinions from consultantclinical toxicologist may be obtained especially for the callsthat have been referred to clinical toxicologist.CONCLUSIONPIC helps in decreasing the incidences of morbidity andmortality due to poisoning and also reducing the costassociated with management of poisoning. In India, there is aneed for centralized database and expert advice ontoxicological service for assisting the physicians andeducating the public in the prevention and management ofpoisoning cases. This can be achieved by establishment ofseveral regional PICs all over India and the networkingsystem between regional PICs and national poisoninformation center. Since only a few regional PICs exists inIndia there is a need for more number of PICs to provide thevital poison information services for management ofpoisoning.REFERENCES1. Lall S B, Peshin S S. Role and functions of poison informationcentre. Indian J Peadiatr 1997;64:443-9.2. Kranzalok E P. International poison information centre datacollection capabilities. Vet Human Toxcol 1995 Jun;37(3):246-8.3. Laborde A. New roles of poison control centres in thedeveloping countries. Toxicology 2004;198:273-7.4. Sam K G, Rajan M S V, Saghir Z, Kumar P, Rao P. Evaluation ofpoison information services of a clinical pharmacy departmentin a south Indian tertiary care hospital. JCDR 2009 Feb;3:1313-8.5. Ponampalam R, Loh C S. Cost benefits of the Drug and PoisonInformation Centre in preventing unnecessary hospitalisation:the Singapore experience. Hong Kong j.emerg.md 2010;17:45-53.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 19

Shobha C - Poison Information Center-An Overview of its Significance, Organization and Functioning6. Ponampalan R, Anatharaman V. The need for drug and poisoninformation –The Singapore physicians' perspective.Singapore Med J 2003;44(5):231-42.7. World Health Organization. Poisoning prevention andm a n a g e m e n t [ O n l i n e ] . A v a i l a b l e f r o m : U R L :http://www.who.int/ipcs/poisons/en/8. Batra A K, Keoliya A N, Jadhav G U. Poisoning: An unnaturalcause of morbidity and mortality in rural India. JAPI 2003Oct;51:955-959.9. Aggarwal P. Need for poison information services in India. NatlMed J India 1995;8 (1):47-49.10. Raymond W, Roberts, Russell W L. A Pharmacist basedtoxicology service. Ann Pharmacother 2007 Oct;41:1719-24.11. Peter A C. Pharmacist as clinical toxicologist: reflection onevolution, challenges and opportunities. Ann Pharmacother2007;41:1708-11.12. Anthony M B , Natalie M B. The nations first control centre:Taking a stand against accidental childhood poisoning inChicago. Vet Human Toxicol 1997;39(2):115-19.13. Krenzelok E P. A hospital based poison information center.PHARM INT 1981;2(11):260-65.14. Tong T G, Becker C E, Foliart D, Morse L. A model poisoncontrol system. West J Med 1982;137:346-50.15. Persson H, Tempowski J. Developing and maintaining quality inpoison information centers. Toxicology 2004;198:263-6.16. Kearney T E, Hiatt P H, Olson K R. Alternative models fortelephone response to pediatric poisoning. Prehosp EmergCare 2007 Sept;11(3):284-92.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 20

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaHealth Related Quality of Life Instruments1 1 2 1 1Muragundi P.M , Anil T.M , Ranjan S.K , Udupa N , Anantha N.N*1Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576104 Karnataka, India2Department of Cardiology, Kasturba Medical College, Manipal University, Manipal-576104 Karnataka, IndiaA B S T R A C TSubmitted: 3/10/2011Accepted: 10/11/2011The current availability of plethora of measurement tools in the area of outcome research often daunts a new comer. The instruments areclassified as disease specific and generic. There is always a need to select at least one from each category as these scales are oftencomplimentary in disclosure. The generic scales aim at assessing the fundamental status of quality of life, whereas disease specific instrumentsaim at assessing the degree of illness along with improvement due to treatments. Health related quality of life instruments gather and provideinformation from the patients about their experiences with the disease and its treatment. Because of the unique perspective offered by healthrelated quality of life instruments, direct measurement of health from the patient's perspective is popular and has replaced more objectivemeasures as the primary outcome of interest for a broad spectrum of clinical conditions. For the purpose of evaluating and conducting studiesthat include patient-reported outcomes, it is important to understand the fundamentals of reliability, validity, and responsiveness of the outcomemeasure being used. There is no single measure of health related quality of life that is found to be appropriate for use in all circumstances but it ispossible that any measure of health related quality of life can be designed to obtain self-reported information. There is no doubt that thisinformation is important for pharmacists in pharmacoeconomics and outcomes research.Keywords: health related quality of life, generic, disease specific, questionnaireINTRODUCTIONHealth care services which are administered by professionalsbut received by patients create different perception amonghealth care providers and patients. For the doctors who areproviders of health care are almost satisfied with clinicaloutcomes. On the contrary, the patients are more satisfiedwith the treatments if the treatments makes a difference forthem as for as the quality of life gets changed. They alsowould appreciate the treatments if they are economicallyaffordable. Traditionally health care was always valued fromclinical point of view, and patient choices were of secondaryimportance. Although this approach forms the base fortraditional assessments, it does not include all the aspects thatare important indicators of health. Measurements are veryimportant in all activities so as to differentiate and rank amongthemselves.A broad definition of health proposed by WHO implicateshealth as a state of complete physical, mental and social well-1being and not merely the absence of disease or infirmity.Address for Correspondence:Anantha Naik N, Professor, Department of Pharmacy Management, ManipalCollege of Pharmaceutical Sciences, Manipal University, Manipal-576104Karnataka, India.E-mail: anantha1232000@gmail.comHence patients' perception about health and its directmeasurement has become vital among researchers measuringoutcomes in clinical research. Measuring patients' perceptionand the extent to which they can actually function in theirdaily activities are very important when the main objective oftreatment is to improve how the patient is feels. Even whenthe aim of treatment is to lower the incidence of apparentlydirect outcomes like stroke or myocardial infarction,collecting the change in patients' function and perception willprovide valuable additional information if change in theadverse morbid outcome varies in severity (pain inosteoarthritis).The technique used to incorporate effects of treatments anddiseases from patients view point is to use Health RelatedQuality of Life (HRQoL) measures. HRQoL is a broadtheoretical construct developed to explain and organisemeasures concerned with the evaluation of health status,values and perceived levels of satisfaction and general wellbeingwith respect to either specific health condition or life as2a whole from individual's perspective. Since many domainsof HRQoL cannot be observed directly, HRQoL instrumentsare developed.HRQoL instruments measure the broad perception of health(physical, mental, and social well-being) known as domains,Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 21

Anantha Naik N -Health Related Quality of Life Instrumentsby explaining the extent of difficulty with activities of dailyliving (including work, recreation, and householdmanagement) and how these difficulties affect relationshipswith family, friends, and social groups. When measuringHRQL it is important that the instrument selected measuresthe health dimensions relevant to that particular set ofpatients. For instance, an instrument intended for use withpatients after myocardial infarction (MI) should take intoaccount the individual's responses to living with the disease,in terms of recreational, occupational, social, personal andsexual relationships, as well as the acute and chronic physicalconsequences of the disease. This is because when someone isill almost all aspects of his or her life may be affected.HRQoL instruments often contain questions that measurebody function (e.g., pain, depression, anxiety) and limitationswith participation in the activities. HRQoL instruments aredeveloped and evaluated according to psychometricprinciples of test theory. This theory proposes that HRQoLvalue can be measured indirectly by asking a series ofquestions. The answers to these questions are then assignednumerical values and these numerical values are combined toyield 'scale scores'. These scale scores are further combined toyield domain scores or summary scores that are eitherstatistically computed or preference based.R O L E O F H R Q o L I N S T R U M E N T S I NPHARMACOECONOMIC EVALUATIONSScarce availability of resources in society compels decisionmakersto balance the benefits and risks of treatment whenthey make decisions for patients. One must also take intoaccount that benefits gained are worth the resources that mustbe spent in providing them. When the resources of family arelimited it has to forgo other benefit, which necessitate theneed for economic analysis to aid informed decision making.The HRQoL instruments can be used to study benefit gainedor perceived by the patients against the resources consumed,thus helping in economic evaluation.The HRQoL instrument chosen will gives us values or utilitieswhich can be understood by the type of question in theinstrument. If questions are asked about certain outcomes itgives us values and if uncertain outcomes it gives us utilities.MEASUREMENT OF HEALTH STATUSPatient preferences for alternative health states can bemeasured either by Time Trade-Off Method or StandardGamble Method. The Time Trade-Off measures values whereas Standard Gamble measures utilities.31. Time Trade-Off Method :In Time Trade-Off patients are asked to imagine living theirlife in present state and to contrast alternative life in perfecthealth for exchange of shorter life period. Patients are posedwith alternative years of life in present status against the yearsof life in perfect health state. Further the Quality AdjustedLife Years (QALYs) is calculated as followsNo. of Years Remaining – No. of Years SacrificedQALYs= ____________________________________________No. of Years RemainingSo, for example, if an individual with 30 years of liferemaining with hip fracture due to osteoarthritis is ready totrade off 15 years to achieve rest of 15 years in full health, theQALYs of 1 year with hip fracture due to arthritis would be0.5.42. Standard Gamble Method :Standard Gamble method measures utility and is based on theUtility Theory, first proposed by Neumann and Morgenstern.The Utility Theory describes how a rational individual makesdecisions when facing uncertainty. Here, patients were askedto imagine about an intervention that would result into perfecthealth but with associated risk of death. Further patients areasked to indicate the highest probability of death risk they arewilling to accept against choosing to remain in their presenthealth condition. If the perceived value of the current healthcondition is low, patient is ready to accept larger probabilityof death risk. Patients are asked to place the utility of presenthealth between death (value 0) and full health (value 1).For example, if a woman suffering from breast cancer isimpassive between her current health state and is willing togamble when the probability of dying is 50%. This wouldmean that the utility the individual places on a year in thathealth state is 0.5, against a year in perfect health, whichwould be worth 1.0.Visual Analogue Scale (VAS) is another commonly usedvalue based measure. VAS allows patients to rate their health5status 0 meaning worst and 100 meaning best.Preference and perception measuring for health states byeither Standard Gamble or Time Trade-Off can be timeconsuming and complex. Hence recently developed prescoredmulti-attribute health status classification system isgaining more popularity among researchers. In theseinstruments, patients were asked to rate their ability tofunction in physical, emotional, and social aspects of life.Here patients report their health state rather than theirpreference for different health states. Some commonly usedinstruments under this category are European Quality of LifeIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 22

Anantha Naik N -Health Related Quality of Life Fig. Instruments 1: Process of HRQoL instrument selectionScale (EQ-5D), Short Form 36 (SF-36), Short Form 6D (SF6D), Health Utilities Index (HUI) and Well-Being Scale.CHOOSING THE RIGHT HRQoL INSTRUMENTSTo provide an assessment of patients HRQoL, researchers caneither select tools that focus on general health status usinggeneric instruments, or they can choose instruments thatfocus on specific aspect of disease under study using diseasespecificmeasures. The choice of right HRQoL instrumentdepends on the objectives of the researcher or decision maker,which may be1. To record treatment outcome2. To differentiate between patients with different diseaseseverity3. To record change in quality of life over a period of treatmentOnce the objectives of assessments are made clear, researchershould look into various aspects like whether the instrumentrequired is disease specific or generic. The various stepsinvolved in selection process of HRQoL instrument areshown in Fig. 1A disease-specific measure is designed to question specificaspects of health that are affected by the disease of interest(deep vein thrombosis). In contrast, a generic instrumentmeasures general health status, including physical symptoms,function, and emotional dimensions of health relevant to all6health states, is including healthy individuals.Disease-specific instruments are more responsive to small but7important changes in health than are generic measures.Because the items on a disease-specific HRQoL instrumentare so focused on a particular disease, conversely, they cannotbe used to compare the impact of one disease with another. Insome cases, disease-specific measures are so specific thatcomparisons between different populations within the samedisease are not possible (e.g., paediatric versus adultpopulations in asthma). On the other hand, generic HRQoLinstruments are useful when measuring the impact of aspecific illness or injury across different diseases, severities,and interventions. For comprehensive picture of a patients'HRQoL, it is often desirable to include combination of both,the generic health and disease-specific instruments.Table 1: List of generic instruments used with permissionSl No Full Name Abbreviated Name123457615-dimensional health-realted quality of life measurehttp://www.15d-instrument.net/15dAffect Balance Scalehttp://www.healthscotland.com/uploads/documents/7568- MHI_Appendix_E_A-E.pdfBrief Hospice InventoryHong G, Perry GF, Mendoza TR, Charles SC. A Preliminary Study of the Utility of the BriefHospice Inventory. Journal of Pain and Symptom Management. 2001 August; 22(2): 637-648.Centers for Disease Control and Prevention Health-Related Quality of Life Measurehttp://www.cdc.gov/hrqol/hrqol14_measure.htmChild Health and Illness Profilehttp://www.childhealthprofile.org/COOP/WONCA Chartshttp://www.rug.nl/gradschoolshare/research_tools/assessment_tools/Coopwonca_handleiding.pdfCOPEhttp://www.psy.miami.edu/faculty/ccarver/sclCOPEF.html15DABSBHICDC HRQOL-14CHIPCOOP-C orCOOP/WON CACOPEIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 23

Anantha Naik N -Health Related Quality of Life InstrumentsSl No Full Name Abbreviated Name89101112131415Client Satisfaction Questionnairehttp://web.mac.com/dr.ben.wright/iWeb/Newham%20Pilot/Questionnaires_file s/10-4%20Satisfaction%20and%20Choice.pdfDuke Health Profilehttp://healthmeasures.mc.duke.edu/Duke Severity of Illness Checklisthttp://healthmeasures.mc.duke.edu/EuroqolEQ-5Dhttp://www.euroqol.org/Family System Testhttp://www.aerc.org.uk/documents/pdfs/FAST_Manual_AERC_VERSION.pdfFunctional Limitations Profilehttp://www.csp.org.uk/outcome-measures/functional-limitations-profile-uk- nameFunctional Status QuestionnaireJournal of General Internal Medicine Volume 1, Number 3, 143-149Groningen Activity Restriction Scalehttps://www.cebp.nl/vault_public/filesystem/?ID=1343CSQDUKEDUSOIEQ-5DFASTFLPFSQGARS16Glasgow Health Status Questionnaireswww.ihr.mrc.ac.uk/app/webroot/.../questionnaires/GHSQManual.doc17Global Quality of Life Scalehttp://www.psy.plym.ac.uk/research/mhyland/default.aspx#QuestionnairesGHSQGQOL18192021222324252627282930Grogono Health Indexhttp://www.grogono.com/health/grogindex.phpHealth and Activity Limitation Indexhttp://www.healthmeasurement.org/Measures.htmlHealth Assessment Questionnairehttp://www.chcr.brown.edu/pcoc/Functi.htmHealth and Labour Questionnairehttp://repub.eur.nl/res/pub/1313/Instrumental Activities of Daily LivingLawton, M.P., and Brody, E.M. “ Assessment of older people: Self-maintaining and instrumentalactivities of daily living. ” Gerontologist 9:179-186, (1969).Illness Behavior QuestionnairePilowsky I, Spence N, Cobb J, Katsikitis M. The Illness Behavior Questionnaire as an aid toclinical assessment. Gen Hosp Psychiatry. 1984 Apr; 6(2):123-30.KIDSCREENhttp://www.mentalhealthpromotion.net/?i=promenpol.en.toolkit.746London Handicap Scalehttps://www.cebp.nl/?NODE=77&SUBNODE=1135Modified Barthel Indexhttp://www.health.gov.au/internet/main/publishing.nsf/Content/ageing- transitionclaimadvance.htm~ageing-transition-claimadvance03.htmMultidimensional Caregiver Strain Indexhttp://www.parkinson.org/NPF-Publication-Library/Checklists/The- Multidimensional-Caregiver-Strain-IndexMultidimensional Health Locus of Control Scaleshttp://www.vanderbilt.edu/nursing/kwallston/mhlcscales.htmMOS Social Support Surveyhttp://www.rand.org/health/surveys_tools/mos/mos_socialsupport.htmlMultidimensional Task Ability Profilehttp://www.mtapsystems.com/PDF/MTAP_2_1_a3%20item.pdfGrogono Health IndexHALexHAQHLQIADLIBQKIDSCREENLHSMBIMCSIMHLCMOS-SSSMTAPIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 24

Anantha Naik N -Health Related Quality of Life InstrumentsSl No Full Name Abbreviated Name313233343536373839404142434445464748495051Nottingham Health Profilehttps://www.cebp.nl/media/m83.pdfOlder Americans Resources and Services Multidimensional Functional AssessmentQuestionnairehttp://www.dementia-assessment.com.au/symptoms/Pediatric Quality of Life Inventoryhttp://www.mapi- trust.org/services/questionnairelicensing/cataloguequestionnaires/84-pedsqlMorale Scale Philadelphia Geriatric Center Morale Scalehttps://www.cebp.nl/vault_public/filesystem/?ID=1460Patient Generated IndexCamilleri-Brennan J, Ruta DA, Steele RJ. Patient generated index: new instrument for measuringquality of life in patients with rectal cancer. World J Surg. 2002 Nov; 26(11):1354-9.Palliative Care Outcome Scalehttp://pos-pal.org/Perceived Quality of Life scalehttp://qol.thoracic.org/sections/instruments/pt/pages/perceive.htmlPhysical Self-Maintenance Scalehttps://www.cebp.nl/?NODE=77&SUBNODE=1139Spitzer's Quality of Life Indexhttp://www.rtog.org/Researchers/QOLPROMaterials/Library.aspxFerrans and Powers Quality of Life Indexhttp://www.uic.edu/orgs/qli/questionaires/questionnairehome.htmFlanagan's Quality of Life Scalehttp://qol.thoracic.org/sections/instruments/fj/pages/flan.htmlQuality of End-of-life care and Satisfaction with Treatment scaleDaniel PS, Jessica MM. Patients ’ Ratings of Quality and Satisfaction With Care at the End ofLife. Arch Intern Med. 2002;162:2098-2104Quebec User Evaluation of Satisfaction with assistive Technologyhttp://www.scireproject.com/outcome-measures/quebec-user-evaluation-of- satisfaction-assistivetechnology-quest-20Quality of Well Being scalehttp://www.healthmeasurement.org/Measures.htmlQuality of Well-Being scale Self-Administeredhttp://www.healthmeasurement.org/Measures.htmlSatisfaction profileBertaccini A, Martinelli A, Ceccarelli R, et al. Development and validation of the BSP-BPH(Bononian Satisfaction Profile--Benign Prostatic Hyperplasia) a "disease-specific" questionnairefor the evaluation of health related quality of life in patients with benign prostatic hyperplasia. ArchItal Urol Androl. 2004 Sep; 76(3):103-9.Santa Clara Strength of Religious Faith Questionnairehttp://www.scu.edu/cas/psychology/faculty/upload/Strength-of-Religious- Faith-Questionnaire.pdfSchedule for the Evaluation of Individual Quality of Lifehttp://epubs.rcsi.ie/cgi/viewcontent.cgi?article=1042&context=psycholrepSilver Lining Questionnairehttp://www.psy.plym.ac.uk/research/mhyland/default.aspx#QuestionnairesSubjective Quality of Life Profilehttp://parqol.com/page.cfm?id=55Service Satisfaction ScaleGreenfield TK, Attkisson CC. Steps toward a multifactorial satisfaction scale for primary care andmental health services. Evaluation and Program Plannina, 1989; 12, 271-278.NHPOARSPedsQLTMPGCPGIPOSPQoLPSMSSQLIQLIQOLSQUESTQUEST 2.0QWBQWB-SASAT-PSCSORFSEIQoLSLQSQLPSSS-30 / SSS- 15 /SSSRESIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 25

Anantha Naik N -Health Related Quality of Life InstrumentsSl No Full Name Abbreviated Name52535455Support Team Assessment Schedulehttp://www.csi.kcl.ac.uk/stastool.htmlSwedish Health-Related Quality of Life SurveyBrorsson B, Ifver J, Hays RD. The Swedish Health-Related Quality of Life Survey (SWED-QUAL),Quality of Life Research, 1993 Feb; 2(1):33-45.Treatment Satisfaction Questionnaire for Medicationhttp://www.quintiles.com/clinical-services/tsqm/WHO (Five) Well-Being Indexhttp://www.who-5.org/STASSWED- QUALTSQMWHO-556World Health Organization Quality of Life assessment instrumentWHOQOL- 100 &http://www.who.int/substance_abuse/research_tools/en/WHOQOL- BREF5758Work Limitations Questionnairehttp://160.109.101.132/icrhps/resprog/thi/wlq.aspYouth Quality of Life Instrumenthttp://depts.washington.edu/yqol/YQOLWLQYQOLTM59Zung Self-rating Anxiety Scalehttp://www.psychresidentonline.com/zung%20anxiety.pdfZungSASSome of the generic HRQoL instruments which are availablefor free or upon request with the author of the instrument arelisted in Table 1 with sources of availability. The Table 2 givesthe list of instruments available on upon payment. Theinstruments commonly used are compiled and listed here andit is not an exhaustive but a sample which are usually used.The examples of disease specific include Adult and DiabetesDependent Quality of Life questionnaire, Seattle AnginaQuestionnaire, Minnesota living with heart failure, AnginaPectoris Quality of Life Questionnaire etc.,Table 2: List of Paid Generic instrumentsSl No Full Name Abbreviated Name12345678910Assistive Technology Device Predisposition Assessmenthttp://truddentechnology.hcpss.wikispaces.net/file/view/Predictors+of.pdfChild Health Questionnairewww.healthact.comHealth and Daily Living Formhttp://www.mindgarden.com/products/hdlfs.htmHealth Status Questionnaire 2.0http://psychcorp.pearsonassessments.com/HAIWEB/Cultures/enus/Productdetail.htm?Pid=PAg124&Mode=summaryHealth Utilities Indexhttp://www.healthutilities.com/McMaster Health Index Questionnairehttp://apntoolkit.mcmaster.ca/index.php?option=com_content&view=article&i d=194:mcmasterhealth-index-questionnaire&catid=44:quality-of-life&Itemid=62Psychological General Well-Being Indexhttp://www.mapi-trust.org/services/questionnairelicensing/cataloguequestionnaires/85-pgwbiPsychosocial Impact of Assistive Device Scalehttp://www.piads.net/9/index1.2.htmlQuality of Life Questionnaire-Evans Copehttp://www.mhs.com/product.aspx?gr=cli&prod=qlq&id=overview#scalesQuality of Dying and Deathhttp://depts.washington.edu/eolcare/instruments/ATD-PACHQHDLFHSQHUIMHIQPGWBIPIADSQLQ-EQODDIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 26

Anantha Naik N -Health Related Quality of Life InstrumentsSl No Full Name Abbreviated Name11Quality Of Life Indexhttp://psychcorp.pearsonassessments.com/HAIWEB/Cultures/en-QOLIus/Productdetail.htm?Pid=PAg511Social Adjustment Scale - Self Report12 http://cognitivecentre.com/social-adjustment-scaleself-report/index.htmlSAS-SRHealth Survey and SF-12v2 Health Survey SF-36 / SF-36v2 SF-3613Health Survey and SF-36v2TM Health SurveySF-12 / SF- 12v2 SF-12www.qualitymetric.com/ SF 36 / SF 36v21415Sickness Impact Profilehttp://www.mapi- trust.org/services/questionnairelicensing/cataloguequestionnaires/118-sipWays of Coping Questionnairehttp://www.mindgarden.com/products/wayss.htmSIPWAYSThe desirable instrument should be having the proof ofA) Reliability (consistency in ratings),B) Validity (representation of theoretical constructs) andC) Responsiveness (detect even small changes)A) Reliability:Reliability quests the consistency of the instrument, does theinstrument produce same score on repeated administrations?Thus confirming the extent to which the instrument is devoidof error. Reliability quests the discrimination power of theinstrument between individuals in a given populationconsistently when respondents are in stable health. Reliabilitywill appear greater when measured in a heterogeneous groupwith higher variability in scores between patients (includespatients with no pain to those with severe pain) than in ahomogeneous group of patients.There are three types of reliability measurements, they area. Test-retest reliabilityb. Internal consistency reliabilityc. Inter-rater reliability8Test-retest reliability evaluates the similarity between healthstatus scores over time when no changes in health haveoccurred. That means if the same person completes HRQoLinstrument and then retakes the same survey after someperiod, if the persons health status has not changed, his or herscores from both attempts should be similar or consistent. It isnormally determined using Cohen's Kappa or Pearson's orSpearman's correlation coefficient. Normally, levels in excessof 0.6 indicate adequate test-retest reliability.Internal consistency is an estimate of homogeneity of itemsmeasuring a specific health domain and is normally measuredusing Cronbach's alpha coefficient. The closer the coefficientis to 1, the greater the homogeneity between the items and,therefore, the greater the confidence. For example considerasking two questions from vitality domain of SF-36 HRQoLinstrument to the person, did you feel full of pep? and did youhave a lot of energy? The questions should produce similaranswer from the person. Internal consistency measure haslimitations as it relates only to the correlation between itemson a single administration, and does not assess the extent ofvariability on repeated administration of a measure.Inter-rater reliability assesses the agreement betweendifferent scores collected by administering the sameinstrument in a group of healthy people.It should be noted that if an instrument is tested and found tobe reliable yet not precise (invalid), meaning the instrumentcan be reliably incorrect. If the instrument in questionconsistently produces incorrect answer, it is reliable but notvalid.9B) Validity :Validity measurements are essential to confirm that the scoresproduced by the instrument truly represent the basicconstructs of HRQoL instrument. In other words, validityassessment of an instrument evaluates whether instrument inquestion measures what is intended. For an instrument to bevalid it must first be reliable otherwise it cannot confirm to theview that the instrument produces results which actuallymeasures basic constructs on readministration. Theassessment of validity of an instrument is easy than thevalidity.There are three types of validity measurements, they area. Content validityb. Construct validityc. Criterion validityd. Discriminant validityContent validity evaluates whether the HRQoL instrumentcontain all facets of relevant variable of interest. ContentIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 27

Anantha Naik N -Health Related Quality of Life Instrumentsvalidation requires standard variables against which theinstrument in question needs to be validated. These standardvariables can be based upon well accepted theoreticaldefinitions of constructs, on existing accepted standards orfrom the experiences of patients affected, health-careproviders or decision makers. Face validity explains whetherthe contents look complete and valid to the examiners whotake it, the administrative personnel who decide on its use,and patients. Content validity always require more stricterstatistical tests than face validity, which only requires anintuitive judgement by the examiner.Construct validity measures the extent to which theinstrument in question actually relates itself to differentmeasures of constructs it should theoretically. Two basic typeof construct validity are convergent and discriminant validity.Convergent validity measures extents to which theinterpretations of scores are similar to the interpretations ofanother instrument measuring similar constructstheoretically.Criterion validity evaluates that HRQoL scores are explicitlyrelated to one or more external outcome criteria. For examplehigher HRQoL scores indicate pharmaceutical therapyadherence hence low morbidity and lower HRQoL scoresmay correlate to non-adherence to pharmaceutical therapyhence high morbidity.Discriminant validity evaluates extent to which differentmeasures and their basic construct can be differentiated fromother theoretically similar constructs.When sufficient evidence is collected to indicate that aninstrument reveals the health concepts, one can conclude thatthe HRQoL instrument is validated. It also mean that theprocess of validation continues till new meaning andinterpretation is given to instrument scores.C) Responsiveness:Responsiveness of an instrument used to measure HRQoL isthe ability of that instrument to identify or detect changes inthe health status of given group of patients. Sometimessensitivity to change and responsiveness are usedinterchangeably, but there are some important differences.Sensitivity to change refers to the ability of an instrument tomeasure true change in the health state being measuredregardless of whether it is relevant or meaningful to thepatient or researcher. In contrast, responsiveness refers to theability of the HRQoL instrument to detect change which isimportant to the patient in the health state being measured10even if that difference is small.Interrelated with the measurement of responsiveness thequest what change in score is clinical difference, which isoften referred as minimally important difference (MID).Hence MID refers to the smallest difference in score in theoutcome of interest that informed patients or informedproxies perceive as important and that would lead the patient11or researcher to consider a change as relevant.REFERENCES1. World Health Organization. 2006. Constitution of the WorldHealth Organization - Basic Documents, Forty-fifth edition,Supplement, October 2006.2. Berger ML, Bingefors K, Hedblom EC,Pashos CL, TorranceGW. Health Care Cost, Quality and Outcomes: ISPOR Book ofTerms. Lawrenceville, NJ: ISPOR; 2003. p. 129-31.3. Torrance GW, Thomas WH, Sackett DL. A utility maximizationmodel for evaluation of health care programs. Health Serv Res.1972;7(2):118–33.4. Von Neumann J, Morgenstern O. Theory of Games andEconomic Behaviour. Princeton, NJ: Princeton UniversityPress. 19445. Schunemann HJ, Griffith L, Stubbing D, Goldstein R, GuyattGH. A clinical trial to evaluate the measurement properties of 2direct preference instruments administered with and withouthypothetical marker states. Med Decision Making. 2003;23(2):140–9.6. Jackowski D, Guyatt G. A guide to health measurement. ClinOrtho Related Res. 2003; 413:80–9.7. Wiebe S, Guyatt G, Weaver B, Matijevic S, Sidwell C.Comparative responsiveness of generic and specific quality-oflifeinstruments. J Clin Epidemiol. 2003; 56 (1):52–60.8. Rascati KL. Essentials of pharmacoeconomics. WoltersKluwer, Baltimore: 2009. p. 117-8.9. Bryant D, Guyott G, Arnold RJ. Patient reported outcomes. In:Arnold RJ editor. Pharmacoeconomics from theory to practice.Florida: CRC Press; 2010. p. 150-1.10. Kirshner B, Guyatt G. A methodological framework forassessing health indices. J Chronic Dis. 1985; 38(1):27–36.11. Schunemann HJ, Guyatt GH. Commentary––goodbye M(C)ID!Hello MID, where do you come from? comment. Health ServRes. 2005; 40(2):593–7.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 28

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaScenario of Pharmacovigilance and ADR Reporting among Pharmacists in DelhiAmrita P*, Roomi M.TDelhi Institute of Pharmaceutical Sciences and Research,Pushp Vihar sector III, M.B. Road, New Delhi, 110017A B S T R A C TSubmitted: 18/10/2011Accepted: 9/11/2011Adverse drug reactions enhance suffering of patients and increase morbidity and mortality. The aim of our study was to evaluate the awarenessof pharmacists working in Delhi regarding pharmacovigilance, adverse drug reaction (ADR) and it's reporting. A questionnaire containing 27questions was prepared and distributed to 230 pharmacists. Response rate of this survey was 64.35%. Out of these, 31.76% were hospitalpharmacists, 26.35% were community pharmacists and 41.89% were medical representatives. Only 40.54% of pharmacists were found toknow the broad meaning of pharmacovigilance. The correct meaning of the term 'adverse drug reaction' was known to 27.70% pharmacists.Majority of pharmacists (77.03%) did not report the ADRs noticed by them. Only 4.05% pharmacists had tentative information that reporting canbe done at national monitoring center and/or regional monitoring centers. Further, only 3.38% pharmacists knew All India Institute of MedicalSciences/Lady Hardinge Medical College as the ADR monitoring centers of Delhi. Out of these, only 0.68% Pharmacists had the phone numberand/or address of these centers. It indicates that the ADR reporting is done by pharmacists at places other than official monitoring centers.Pharmacists reported ADRs to physicians, manufacturing industry, product management team and chief pharmacist. Pharmacists in Delhi havepoor basic knowledge of pharmacovigilance, ADR and its reporting. Pharmacist's participation in ADR reporting is negligibly low. Education andtraining of pharmacists is essential to improve the ADR reporting. Pharmacist's active participation along with other healthcare providers wouldincrease the ADR reporting rate. Pharmacovigilance should be included in the pharmacy curriculum.Keywords: Adverse drug reaction, ADR reporting, Pharmacovigilance, Pharmacist.INTRODUCTIONIn 1960, use of Thalidomide for prevention of morningsickness by pregnant women gave excellent results but thedisaster struck when phocomelic babies were born. Thisforced the healthcare professionals to become aware aboutthe adverse drug reactions, its implications on patient safetyand cost of treatment. Adverse drug reaction is a response to amedicine which is noxious and unintended and which occursat a dose used in humans for prophylaxis, diagnosis, therapy1or modification of physiological functions. ADRs add to thesuffering of patients and increase morbidity and mortalitybesides being a financial burden on society. It has beenestimated that ADRs cause up to 7% of all hospitaladmissions in the UK and 13% of all admissions to internal2medicine clinics in Sweden. In New Zealand, 12.9% of all3hospital admissions are due to adverse drug events. Fataladverse drug reactions rank among the most common causes4of death in the United States. ADRs have been estimated toAddress for Correspondence:Amrita Parle, Delhi Institute of Pharmaceutical Sciences and Research,PushpVihar sector III, M.B. Road, New Delhi, 110017E-mail: amrita.parle@gmail.com,account for up to 1,06,000 deaths annually in the United4,5States. The study of Bord et al indicated that, in patients whoexperience ADRs, death rates were 19.18% higher and the6length of hospital stay is 8.25% higher.India has become a destination for conducting clinical trials.During clinical trials, medicines are generally studied in acontrolled environment, for a relatively small number ofpatients, and usually for a limited duration. These trialssometimes exclude the elderly, the very young, and patientswith co-morbidities. Often patients on multiple drug therapyand patients with decreased renal and hepatic function areexcluded. For these patient populations, any vulnerability toADRs may be missed. Adverse reactions may occur at such alow frequency that they are not being detected in the smallnumbers of patients included in clinical trials. Furthermore, itis extremely difficult to predict how practitioners willactually use medications in practice. Once the drug iscommercially available, the exclusion criteria applied inclinical trials, no longer exist. Thus, exposure to the drug maylast longer, as therapy may continue long term, increasing thepossibility of previously undetected problems to arise and beidentified. Additionally, widespread use of medicines in thegeneral population can increase the chances for uncoveringIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 29

Amrita P - Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in Delhiadverse reactions occurring at low frequency and thus notpreviously detected during the marketing approval process.Pharmacovigilance is the science and activities relating to thedetection, assessment, understanding and prevention of7adverse effects or any other possible drug related problem.Spontaneous reporting of ADRs remains the keystone ofpharmacovigilance. To improve the pharmacovigilanceactivities in India, the Ministry of Health and Family Welfarehad initiated the National Pharmacovigilance Program (NPP)8,9on 1 January 2005 which was further revived in July 2010. Itis coordinated by the Central Drugs Standard ControlOrganization (CDSCO) in New Delhi. The program isenvisaged to be rolled out in three phases:Ÿ Phase I plans to include 40 ADR monitoring centers(AMCs).Ÿ Phase II plans to include 140 MCI recognized medicalcolleges by end of 2011.Ÿ Phase III would ultimately cover the total healthcaresystem by 2013.ADR reports will be collected at the AMCs which will then bedispatched to the coordinating centre as per the standardoperating procedures. Once the reports are received, they arestudied and evaluated, the data generated can help to estimaterisk patterns such as identifying populations at risk ofdeveloping an ADR and investigating the preventability ofthese ADRs. Pharmacovigilance program disseminates theinformation generated from these reports to regulatoryauthorities to update drug labeling and, on occasions, to reevaluatethe approval or marketing decision. Thus effectivesurveillance is essential in every country for monitoring theoccurrence of ADRs, as the data derived from within thecountry may encourage national regulatory decision making.These programs may contribute to decrease morbidity,mortality, length-of- hospital stay, healthcare costs, andliability associated with ADRs. However ADR monitoring10and reporting activity is in its infancy in India. ADRreporting rate in India is just 1% as compared to world rate of115%. Many studies have shown that active involvement ofpharmacists is critical for success of pharmacovigilance12,13system. In addition to their responsibilities regarding drugdispensing and compliance, pharmacists can have asubstantial role in ADR monitoring. The variouspharmaceutical disciplines like pharmacology, clinicalpharmacy, greatly enhance our understanding of the nature ofADR. If those involved in pharmaceutical disciplines can riseto this challenge, they will significantly help deepen ourinsights into ADR and its reporting. As per van Grootheest Ket al, major improvements can be made and the extent ofunderreporting of ADR can be considerably reduced byactively involving pharmacists in the surveillance of drugsafety within the context of the pharmaceutical care that they14provide. In Canada or the US the majority of the ADR15reports come from pharmacists.In the light of above reports, present study was undertaken toascertain the awareness of pharmacists of Delhi, Capital ofIndia, about the pharmacovigilance and ADR reporting.The primary objectives of our study were:-1. To evaluate pharmacists knowledge aboutpharmacovigilance and ADR reporting system.2. To assess the attitude of the pharmacists towardsspontaneous reporting of ADR.3. To assess the participation of pharmacists in ADRreporting.4. To identify the reasons for under-reporting.5. To suggest methods for the improvement in the currentspontaneous ADR reporting system.MATERIALS AND METHODSResearch Design: This was a cross sectional study involvingpharmacists who were surveyed with a questionnaire. Thestudy was conducted over a period of 8 months from Dec2009 to July 2010. The study was conducted in Delhi, theNational capital of India. Entire area of Delhi was coveredwhich included North, East, West, South and Central zones ofDelhi. Our volunteers personally visited the pharmacists,gave the questionnaire and collected the completedquestionnaire on same day.Material used: A questionnaire containing 27 questions wasprepared. First five questions were designed to generatedemographic information about the name, qualification, post,sector and experience. The remaining questions weredesigned to evaluate knowledge (9 questions), to judge skills(7 questions) and to assess their attitude (6 questions) aboutpharmacovigilance and ADR reporting.The knowledge oriented questions revealed informationabout their understanding of pharmacovigilance, ADR,expected therapeutic effects, possible side effects, phonenumber and address of pharmacovigilance centers in Delhi,pharmacogenomics and pharmacoeconomics. Further theywere asked to choose the place of ADR reporting, from givenmultiple choice of - hospital pharmacy, physician,manufacturing industry, regional monitoring centre andnational monitoring centre.Questions on skills covered various activities or inputs givenby pharmacists to strengthen pharmacovigilance and ADRIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 30

Amrita P - Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in Delhireporting, like – informing patients about possible sideeffects, noticing ADRs in patients, getting feedback ofdiscomfort experienced by patient after drug treatment,reporting/non-reporting of observed ADR, existence of setprocedure of reporting ADR in their organization.Questions on attitude regarding pharmacovigilance helped toknow their opinion on essentiality of ADR monitoring andcontinuing education programs and possible reasons for nonreportingof an encountered ADR viz. ADR is well known,not sure about the drug causing ADR. Their perceptionregarding inclusion of pharmacovigilance in pharmacycurriculum was probed.Subjects: The study included those pharmacists who havedirect contact either with patients or the physicians viz.community pharmacists (C.P), hospital pharmacists (H.P)and the medical representatives (M.R). The questionnairewas distributed to 230 pharmacists. Out of these, 148pharmacists responded by returning the duly completedquestionnaire. The community pharmacists were from thevarious medical shops of Delhi. The hospital pharmacistswere working in following government or private sectorhospitals/dispensaries.Govt. sector hospitals:1. All India Institute of Medical Sciences and Research(10.64%).2. Guru Gobind Singh Govt. Hospital (10.64%).3. Safdarjung Hospital (12.77%).4. Lady Hardinge Medical College and Hospital (10.64%).5. Charak Palika Hospital (10.64%).6.Primary Health Centre, Mehrauli (2.13%).7. Pt. Madan Mohan Malaviya Hospital (8.51%).8.Kalavati Saran Children's Hospital (10.64%).Private sector hospitals:1.G.M Modi hospital (2.13%).2. Sitaram Bhartia hospital (6.38%).3. Rockland hospital (2.13%).4. Batra Hospital and Medical Research Centre (2.13%)Dispensaries:1. Delhi Govt. Dispensary, Ber Sarai (4.26%).2. C.G.H.S Dispensary, R. K. Puram (6.38%).The medical representatives were serving in followingpharmaceutical organizations:- Astra Zeneca, SolvateLaboratories, Glenmark Pharmaceuticals, Biomate India,Novo Nordisk, Sun Pharma, Ipca Laboratories, Wockhardt,Lupin Pharmaceuticals, Eli Lilly, Orange Laboratories,Torrent Pharmaceuticals, Dr. Reddy's Laboratories,Zuventus, Mohrish Pharmaceuticals, Universal Medicare,Franco-Indian Pharmaceuticals, Alkem Laboratories, PfizerIndia, Glaxosmithkline Pharmaceuticals, AimilPharmaceuticals, Cipla Pharmaceuticals, Apex laboratories,Intas Pharmaceuticals, Mark Medicines, Aventis Pharma,Jagsonpal Pharmaceuticals, Ranbaxy Laboratories, Unichemlaboratories, Perron Pharmaceuticals, WingsPharmaceuticals, Samarth Life Sciences and PiramalHealthcare.RESULT AND DISCUSSIONOut of 230 questionnaires that were distributed, 148 werefilled, giving a response rate of 64.35%. Table 1 describes thedemographic distribution of the pharmacists. Profession wiseclassification shows that 31.76% were hospital pharmacists,26.35% were community pharmacists and 41.89% weremedical representatives (Fig 1).Fig. 1: Profession wise participation of pharmacistsKnowledge of pharmacists:Out of the total (148) pharmacists, 60 (40.54%) reported thatthey are aware of the term pharmacovigilance but only 41(27.70%) pharmacists knew the term ADR indicating that outof 60 pharmacists who said they knew the termpharmacovigilance, 19 pharmacists have possibly faked thatthey had knowledge of pharmacovigilance. Fifty nine(39.86%) pharmacists did not know the termpharmacovigilance and 29 (19.59%) pharmacists did notrespond indicating that total 59+29+19 =107 (72.30%)pharmacists did not know the term pharmacovigilance. Fortynine (33.11%) pharmacists did not understand the meaning ofADR and 58 (39.19%) pharmacists did not respond. ThusIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 31

Amrita P - Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in DelhiTable 1: Demographics of Total Pharmacists (148)Qualification Sex Sector ExperiencePharm. Others Male Female Govt. Pvt. 0-5 5-10 10-15 15-20 ≥ 20years years years years yearsNo. 96 52 137 11 41 107 63 29 15 18 23% 64.86 35.14 92.57 7.43 27.70 72.30 42.57 19.59 10.14 12.16 15.54total 49+58=107 (72.30 %) pharmacists did not understandthe meaning of ADR. Effectively only 27.70% pharmacistswere aware of the term pharmacovigilance and ADR. TokluHZ et al in his study conducted in Turkey found that only17.2% of the pharmacists had any knowledge about16pharmacovigilance.One hundred fifteen (77.70%) pharmacists knew about thetherapeutic effects of the prescribed drugs, 5 (3.38%) did notknow about the therapeutic effects of prescribed drugs while28 (18.92%) did not respond indicating that 33 (22.30%)pharmacists did not know even the expected therapeuticeffects. One hundred thirteen (76.35%) pharmacists knewabout the possible side effects of the prescribed drugs,8(5.40%) did not know while 27 (18.24%) did not respond.There is a discrepancy in the response of the pharmacist. Asstated above 107 (72.30%) pharmacists did not understandthe term ADR but 113 (76.35%) pharmacists reported thatthey know the possible side effects of prescribed drugs. Thisis possibly because the pharmacists were more apt to the termside effect and did not know the meaning of adverse drugreaction. They did not understand that- A side effect is usuallya predictable or dose-dependent effect of a drug that is not theprincipal effect for which the drug was chosen; the side effect17can be desirable, undesirable or inconsequential while theadverse effect is always undesirable. This indicates thatpharmacists lack correct knowledge of ADR and side effect.Only 6 (4.05%) pharmacists had faint idea that reporting canbe done at National Monitoring Center (NMC) and/orRegional monitoring centers (RMC) because NMC and RMCwere one of the many options chosen by them for place ofADR reporting. Five (3.38%) pharmacists knew themonitoring centers of Delhi as All India Institute of MedicalSciences (AIIMS) and Lady Hardinge Medical College(LHMC). Out of these, only 1 (0.68%) pharmacist had thephone number and/or address of these centers. It indicatesthat pharmacists report ADR at places other than NMC andRMC. Pharmacists said that they report ADRs to Physician,Manufacturing Industry, Department in-charge, ProductManagement Team, Chief Pharmacist and purchasingdepartment of hospital. Nine (6.08%) pharmacists felt thatthey did not report ADR because they did not know where toreport. This indirectly indicates that 139 pharmacists knewwhere to report ADR but this is contradictory to the fact thatonly one pharmacist had phone number and address ofreporting centers. Thus we can say that pharmacists wereignorant about the existence of NMC/RMC as well as theguidelines of NPP that ADRs should be reported in the ADRreporting form and sent to the monitoring centers. Only 6( 4 . 0 5 % ) p h a r m a c i s t s k n e w a b o u t t h e t e r mpharmacoeconomics while 142 (95.95%) pharmacists werenot aware about pharmacoeconomics. Thus pharmacists arenot contributing in reducing the cost of treatment bysuggesting efficacious as well as cheaper alternativebrand/generic products of the prescribed drugs. Only 4(2.70%) pharmacists knew the term pharmacogenomicswhile 144 (97.30%) pharmacists were not aware about themeaning of this term. Thus we can conclude that thek n o w l e d g e l e v e l o f p h a r m a c i s t s r e g a r d i n gpharmacovigilance and related activities is low. Similarpattern was noticed by Vessal G in Iran. He states that Iranianpharmacists have little knowledge regarding the operation,purposes, and usefulness of ADR spontaneous reporting18system.Intra-Profession response for knowledge:The response of the pharmacists was further classified as pertheir profession as hospital pharmacist, communitypharmacist or medical representative. For intra-professionalcomparison, the percentage is calculated by taking 47 as adenominator for hospital pharmacists, 39 as a denominatorfor community pharmacists and 62 as a denominator formedical representatives. Figure 2 gives the comparisonbetween knowledge level of hospital pharmacists,community pharmacists and medical representativesregarding pharmacovigilance. The hospital pharmacists weremore aware about the pharmacovigilance (48.93%), ADR(31.91%), expected therapeutic effects of drugs (87.23%),possible side effects of prescribed drugs (87.23%) andpharmacoeconomics (8.51%) than community pharmacistsand medical representatives. It was further found that medicalrepresentatives had least awareness regardingpharmacovigilance (35.48%), ADR (25.81%), possible sideeffects (67.74%) and expected therapeutic effects (69.36%).Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 32

Amrita P - Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in DelhiFig. 3: Intra-profession correlation regardingPharmacovigilance skillsJ- Inform patients about therapeutic effects, K- Inform patientsabout side effects, L- Do patient inform you about side effects,M- Do you report ADR, N- Have set procedure of reporting ADRin their organization, O- Have ADR reporting form.interaction between hospital pharmacists and patients wasfound to be best among the three. This is indicated from theresponse that, 57.44 % of hospital pharmacists, 46.15% ofcommunity pharmacists and 33.87% of medicalrepresentatives were informed by the patients/physicianabout the side effects experienced by patients. Involvement ofhospital pharmacists (44.68%) in reporting ADR was greaterthan the medical representatives (14.51%) and communitypharmacists (10.25%). The study of van Grootheest AC et al,reported that contribution of hospital pharmacists to ADR22reporting in Canada and United States is by far the largest. Incontrary the study of Su C et al showed that hospitalpharmacists in a northern region of China had a reasonableknowledge of and positive attitudes towardspharmacovigilance, however the majority of pharmacists had23never reported an ADR in their career.In our study involvement of community pharmacists in ADRreporting is lowest. This may be due to sub-optimal level ofknowledge about the drugs, lack of confidence and inaptprofessional approach. Our community pharmacists restrictthemselves to mere dispensing of marketed preparations.Contrary to our observation, van Grootheest AC et al reportedthat in Netherlands, community pharmacists play asignificant role in ADR reporting. They contributesubstantially, both in numbers and in quality of ADR reports.In Netherlands the contribution of community pharmacists to24professional ADR reports is 40.02%. In Japan and Spain39% and 25.9% professional ADR reports originate from22community pharmacists.Hospital pharmacists (19.14%) and medical representatives(16.12%) reported that they have set channel for reportingADR, while 97.44% of community pharmacists said they donot have any channel for reporting ADR. Establishing achannel for reporting ADR and informing about the same tothe practicing pharmacists, would promote the reporting bypharmacists. Though 44.68% of hospital pharmacists,14.51% of medical representatives and 10.25% ofcommunity pharmacists reported observed ADRs, only2.56% of community pharmacists, 2.12% of hospitalpharmacists and 3.22% of medical representatives had ADRreporting form. From this data, it is once again very clear thathospital pharmacists, community pharmacists and medicalrepresentatives report the ADR verbally to chief pharmacist,physician, purchasing department of hospital, manufacturingindustry, department in-charge, product management teamand not to the NMC, RMC or peripheral monitoring center.This kind of reporting is not of much help in ensuring patientsafety.In a Malaysian study, community pharmacists claimed tohave some knowledge of a reporting system but the actualreporting was insignificant. Further all of them agreed that it25was part of their professional obligation to report an ADR.Survey by Toklu Hz et al shows that Turkish communitypharmacists have poor knowledge about pharmacovigilance16with just 7% ADR reporting by them.Attitude of pharmacists:One hundred sixteen (78.38%) pharmacists felt that the ADRmonitoring is essential. Four (2.70%) pharmacists felt ADRmonitoring is not essential while 28 (18.92%) pharmacistsdid not respond. It may be possible that these pharmacists didnot understand the meaning of ADR monitoring. The studyof Granas AG et al conducted in Norway also shows that26pharmacists had positive attitudes towards ADR monitoringwhile study of Vessal G et al conducted in Iran shows thatmore than half of the responding pharmacists felt that ADRreporting should be voluntary, while 26% felt it to be a18professional obligationNineteen (12.84%) pharmacists felt that there is no need toreport the ADR as it is well known. But as per the CDSCOGuidelines even the minor ADRs should be reported as it may27throw light on prescribing patterns. Ninety five (64.19%)pharmacists felt that pharmacists are not trained enough fordetecting and reporting ADR. Out of 148 participatingpharmacists only 56 (37.84%) pharmacists said they undergocontinuing education program. One hundred eleven (75%)pharmacists were of the opinion that education and training inpharmacovigilance would play a pivotal role in improvingADR reporting. The study of Sweis et al and Green et alconducted in UK and study of I. Ribeiro Vaz et al in PortugalIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 34

Amrita P - Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in Delhiconfirm that education and/or training improves ADR28,29,30reporting.Eighty seven (58.78%) pharmacists exhibited the need thatp h a r m a c o v i g i l a n c e , p h a r m a c o e c o n o m i c s a n dpharmacogenomics should be included in the curriculum ofDiploma and Degree in pharmacy.Intra-Profession response for Attitude:The response of the pharmacists for attitude related questionswas further classified as per their profession as hospitalpharmacist, community pharmacist or medicalrepresentative. Figure 4 gives the comparison betweenattitude of hospital pharmacists, community pharmacists andmedical representatives regarding pharmacovigilance. FromFig 4 it is clear that among the three, hospital pharmacist'sresponse for essentiality of ADR monitoring, was highest,that is 87.23% while, medical representatives had leastawareness regarding importance of ADR reporting (72.58%).In our study, 76.92% community pharmacists felt that ADRmonitoring is essential. However, in Malaysia, study of TingKN et al showed that all participating communitypharmacists considered ADR reporting as crucial part of their25professional obligation.Though the hospital pharmacists had better knowledge andskill, the feeling that they lack education and training forreporting ADR, was maximum in them followed bycommunity pharmacists (61.53%) and then medicalrepresentatives (59.67%). The need of education and trainingin ADR reporting was vehemently expressed by hospitalpharmacists (85.11%) which was trailed by communityFig. 4: Intra-profession correlation regarding attitudetowards Pharmacovigilancepharmacists (71.79%) and medical representatives (69.35%).The participation of hospital pharmacists, communitypharmacists and medical representatives in continuingeducation programs was 25.53%, 43.58%, 43.54%respectively. In India, medical representatives are made toundergo induction training by pharmaceutical industriesbefore commencement of the field job. Pharmacovigilanceand ADR reporting should be included in induction trainingsfor not only medical representatives but also for hospitalpharmacists. Before granting approval for opening a medicalstore induction training should be made mandatory forcommunity pharmacists. As per the study of Davis et alcontinuing stimulation and education of hospital pharmacists31is necessary to improve ADR reporting.Hospital pharmacists (80.85%) were more inclined forinclusion of pharmacovigilance in pharmacy curriculum thancommunity pharmacists (61.53%) and medicalrepresentatives (40.32%). Mainly, hospital pharmacists wereof the opinion that underreporting was due to the uncertaintyof drug causing it (19.14%). The feeling that, untowardsymptoms experienced by the patient (ADR) are well knownwas more prominent in community pharmacists (20.51%)than hospital pharmacists (12.76%) and medicalrepresentatives (8.06%). The study of Irujo M et al conductedin Spain shows that one of the major reason for not reportingADR by community pharmacists was the feeling that ADR is32well known.Overall the attitude of hospital pharmacists was positive forpharmacovigilance related activities.Knowledge, attitude and skills of pharmacists withreference to demographic indicators:Table 1, 2, 3 and 4 gives demographic data of totalpharmacists, hospital pharmacists, community pharmacistsand medical representatives respectively.Qualification:P- Essentiality of ADR monitoring, Q- Lack training for reportingADR, R- Essentiality of education and training for increasingADR reporting, S- Underwent continuing education program, T-Should pharmacovigilance be part of pharmacy curriculum, U-Underreporting due to uncertainty of drug causing it, V-Underreporting due to feeling that ADR is well knownA startling fact came forward after analyzing the qualificationof the pharmacists that out of 148 practicing pharmacists, 52(35.14%) did not have any pharmacy qualification. Thoughpharmacy qualification is essential for practicing communitypharmacy or for opening chemist shop/medical shop, it wasobserved that pharmacists are not available in the shop. In thisstudy, 30.77% community pharmacists lacked pharmacyqualification. This shows the gap in the drug regulatorypolicy and its actual implementation. Among thepharmacists, the knowledge of medical representativesregarding pharmacovigilance was least which can beattributed to the fact that 64.52% of them were devoid ofIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 35

Amrita P - Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in DelhiTable 2: Demographics of Hospital Pharmacists (47)Qualification Sex Sector ExperiencePharm. Others Male Female Govt. Pvt. 0-5 5-10 10-15 15-20 ≥ 20years years years years yearsNo. 47 0 38 9 41 6 3 11 2 13 18% 100 0 80.85 19.15 87.23 12.77 6.38 23.40 4.26 27.66 38.30Table 3: Demographics of Community Pharmacists (39)Qualification Sex Sector ExperiencePharm. Others Male Female Govt. Pvt. 0-5 5-10 10-15 15-20 ≥ 20years years years years yearsNo. 27 12 38 1 0 39 5 14 12 4 4% 69.23 30.77 97.44 2.56 0 100 12.82 35.90 30.77 10.26 10.26Table 4: Demographics of Medical Representatives (62)Qualification Sex Sector ExperiencePharm. Others Male Female Govt. Pvt. 0-5 5-10 10-15 15-20 ≥ 20years years years years yearsNo. 22 40 61 1 0 62 55 4 1 1 1% 35.48 64.52 98.39 1.61 0 100 88.71 6.45 1.61 1.61 1.61pharmacy qualification. Pharmacy qualification should bemade mandatory for the medical representatives. All hospitalpharmacists (100%) had pharmacy qualification.Gender:Out of the total 148 pharmacists, only 11 (7.43%) werefemales. Further study shows that out of 39 communitypharmacists only 1 (2.56%) was female, out of 62 medicalrepresentatives only 1 (1.61%) was female while out of 47hospital pharmacists, 9 (19.15%) were females. Thus we cansay that males predominate as community pharmacists,hospital pharmacists, and medical representatives overfemales. There was no gender wise difference in theknowledge, attitude and skills of pharmacists regardingpharmacovigilance, ADR reporting and monitoring.Sector:It was observed that out of 148 pharmacists, 41 (27.70%)pharmacists were working in the government sector and all ofthem were hospital pharmacists. There are no medical shopsrun by the government sector and thus all the communitypharmacists (39, 100%) belong to private sector. Similarly allthe medical representatives belong to private sector. Theknowledge, attitude and skills of the pharmacists working ingovernment sector were superior to the pharmacists workingin the private sector.Experience:There was no significant difference in the response ofpharmacists with different levels of experience. Experiencedid not have any correlation with the level of knowledge,skill, attitude of pharmacists about pharmacovigilance andADR reporting.Summary of results:In nutshell, hospital pharmacists were more aware about thepharmacovigilance (48.93%), ADR (31.91%), expectedtherapeutic effects of drugs (87.93%), possible side effects ofprescribed drugs (74.46%) and also they were involved morein informing patients about the expected therapeutic effects(82.97%), possible side effects of drugs (74.46%) and inreporting ADR. It is interesting to note that knowledge, skilland attitude of hospital pharmacists about pharmacovigilanceand ADR reporting was highest. This may be due to theirpharmacy education and constant contact with healthcareprofessionals and patients in the hospital setting. In addition,all of them cleared the stringent selection proceduresensuring good knowledge base while entering governmentsector.The overall reporting by pharmacists of Delhi to ADRmonitoring centers is abysmal.Main reasons of underreporting:Main reasons for negligible reporting of ADR by pharmacistsare summarized in Figure 5.These are-Ÿ Pharmacists lack of knowledge regardingpharmacovigilance (59.46%).Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 36

Amrita P - Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in DelhiFig. 5: Main reasons for under-reportinga- Not aware about pharmacovigilance, b- Not aware ofmeaning of ADR, c- Not aware of correct reporting centers, d-Did not have phone no. and address of pharmacovigilancecenters in Delhi, e- Not trained enough for reporting fordetecting and reporting ADR, f- Did not have ADR reportingformŸ They are unaware of the meaning of ADR (72.30 %).Ÿ They are ignorant about the reporting centers in India(95.95%).Ÿ Pharmacists did not have the phone number and addressof pharmacovigilance centers in Delhi (99.32%).Ÿ Pharmacists are not trained enough for detecting andreporting ADR (64.12%).Ÿ Pharmacists did not have the ADR reporting form(97.30%).Suggestions for improving ADR reporting by pharmacists:1) Conducting regular workshops for pharmacists forimparting training regarding pharmacovigilance, ADR, ADRreporting forms, reporting centers, procedure of reporting andbenefits of reporting.2) Periodical meetings of experts from NPP with pharmaciststo motivate pharmacists for ADR reporting.3) Easy availability of ADR reporting forms to pharmacists.4) Each hospital should build local pharmacovigilance unitfor disbursement and collection of ADR reporting forms.5) The NPP should periodically collect ADR forms fromhospitals by sending representatives.6) Facilitate ADR reporting by e-mail, fax and phone.7) Incorporation of pharmacovigilance in the syllabus.8) Incentive for each ADR reported.9) Felicitation for maximum/active ADR reporting.10) Assurance of non involvement in legal matters, if theyarise.11) Introduction of ADR drop boxes at strategic sites.12) The regulatory authorities should make it mandatory thatall medical representatives should have pharmacyqualification and should ensure that only qualifiedpharmacists are engaged in practicing pharmacy in medicalshops.13) Medical representatives may be made to act as a key-linkbetween physician, manufacturing industry and ADRmonitoring centers.1 4 ) S e n d i n g n e w s l e t t e r s , l e a f l e t s c o v e r i n gpharmacovigilance activities.15) Positively changing the mindset so that ADR reportingbecomes an accepted and understood routine.CONCLUSIONPharmacists in Delhi have very little basic knowledge ofpharmacovigilance, ADR and its reporting. The overallreporting by pharmacists of Delhi to National ADRmonitoring centers is abysmal. Education and training ofpharmacists is vital to improve the current ADR reportingsystem. Pharmacovigilance should be included in pharmacycurriculum. Pharmacists active participation in spontaneousreporting would go a long way in ensuring patient safety.ACKNOWLEDGEMENTThe authors wish to thank all the pharmacists whoparticipated in the study.REFERENCES1. Safety of medicines: A guide to detecting and reportingadverse drug reactions. Geneva:World Health Organization;2002.2. Severino G, Del Zompo M. Adverse drug reactions: Role ofpharmacogenomics. Pharm Res. 2004;49(4):363–373.3. Chamberlin N. The folly of rewarding silence while hoping foropen reporting of adverse medical events – how to realign therewards. N Z Med J. 2008;121(1282):58–66.4. Lazarou J, Pomeranz BH, Corey PH. Incidence of adversedrug reactions in hospitalized patients: a meta-analysis ofprospective studies. JAMA 1998;279(15):1200–5.5. Bates D: Drugs and adverse drug reactions. How worriedshould we be? JAMA. 1998;279(15):1216-7.6. Bord CA, Rachl CL. Adverse drug reactions in United Stateshospitals. Pharmacotherapy. 2006;26(5):601–8.7. World Health Organization (WHO) (A). The importance onPharmacovigilance Safety Monitoring on Medicinal Products.Geneva (Switzerland): Office of Publications, World HealthOrganization; 2002:7-7.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 37

Amrita P - Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in Delhi8. Biswas P, Biswas AK. Setting standards for proactivepharmacovigilance in India: The way forward. Indian JPharmacol 2007;39:124-8.9. Gupta YK. Ensuring Patient Safety - Launching the NewPharmacovigilance Programme of India. Pharma Times2010;42(08):21-6.10. Jose J, Rao PG. Pattern of adverse drug reactions notified byspontaneous reporting in an Indian tertiary care teachinghospital. Pharmacol Res. 2006;54(3):226-33.11. Prakash S. Pharmacovigilance in India. Indian J Pharmacol.2007;39:123.12. Terceros Y, Chahine-Chakhtoura C, Malinowski JE et al.Impact of a pharmacy resident on hospital length of stay anddrug-related costs. Ann Pharmacother. 2007;41(5):742-8.13. Phansalkar S, Hoffman JM, Nebeker JR et al. Pharmacistsversus non-pharmacists in adverse drug event detection: ameta-analysis and systematic review. Am J Health SystPharm. 2007;64(8):842-9.14. Grootheest VK, Olsson S, Couper M et al. Pharmacists' role inreporting adverse drug reactions in an internationalperspective. Pharmacoepidemiol Drug Saf. 2004;13:457-464.15. The Learning Centre. Continuing pharmacy education;fall1999. Canada: University of British Columbia; 1999.16. Toklu HZ , Uysal MK. The knowledge and attitude of theTurkish community pharmacists toward pharmacovigilance inthe Kadikoy district of Istanbul. Pharm World Sci.2008;30(5):556-62.17. Rehan HS, Deepti C, Kakkar AK. Physician's guide topharmacovigilance: Terminology and causality assessment.Eur J Intern Med. 2009;20:3-8.18. Vessal G, Mardani Z, Mollai M. Knowledge, attitudes, andperceptions of pharmacists to adverse drug reaction reportingin Iran. Pharm World Sci. 2009;31(2):183-7.19. Oreagba IA, Ogunleye OJ, Olayemi SO. The knowledge,perceptions and practice of pharmacovigilance amongstcommunity pharmacists in Lagos state, south west Nigeria.Pharmacoepidemiol Drug Saf. 2011;20(1):30-5.20. Olsson S. National Pharmacovigilance Systems: CountryProfiles and Overview. 2nd ed.Uppsala: Uppsala MonitoringCentre; 1999.21. Zolezzi M, Parsotam N. Adverse drug reaction reporting inNew Zealand: Implications for pharmacists. Ther Clin RiskManag. 2005;1(3):181–188.22. Grootheest VAC, Berg VLTW. The role of hospital andcommunity pharmacists in pharmacovigilance. Res SocialAdm Pharm 2005;1:126-33.23. Su C, Ji H, Su Y. Hospital pharmacists' knowledge andopinions regarding adverse drug reaction reporting inNorthern China. Pharmacoepidemiol Drug Saf.2010;19(3):217-22.24. Grootheest VAC, Puijenbroek VEP, Berg VLTW. Contributionof pharmacists to the reporting of adverse drug reactions.Pharmacoepidemiol Drug Saf. 2002;11:205–210.25. Ting KN, Stratton-Powell DM, Anderson C. Communitypharmacists' views on adverse drug reactions reporting inMalaysia: a pilot study. Pharm World Sci. 2010;32(3):339-42.26. Granas AG, Buajordet M, Stenberg-Nilsen H et al.Pharmacists' attitudes towards the reporting of suspectedadverse drug reactions in Norway. Pharmacoepidemiol DrugSaf. 2007;16(4):429-34.27. Protocol for National Pharmacovigilance Program. CDSCO,Ministry of Health and Family Welfare, Government of India.November 2004.28. Sweis D, Wong ICK. A survey on factors that could affectadverse drug reaction reporting according to hospitalpharmacists in Great Britain. Drug Saf. 2000;23:165–72.29. Green CF, Mottram DR, Rowe PH et al. Attitudes andknowledge of hospital pharmacist to adverse drug reactionreporting. Br J Clin Pharmacol. 2001;51:81–6.30. Ribeiro-Vaz I, Herdeiro MT, Polónia J et al. Strategies toincrease the sensitivity of pharmacovigilance in Portugal. RevSaude Publica. 2011;45(1):129-35.31. Davis S, Coulson RA, Wood SM. Adverse drug reactionreporting by hospital pharmacists:the first year. Pharm J.1999;262:366–7.32. Irujo M, Beitia G, Bes-Rastrollo M et al. Factors that influenceunder-reporting of suspected adverse drug reactions amongcommunity pharmacists in a Spanish region. Drug Saf.2007;30(11):1073-82.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 38

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaEvaluation of the Impact of a Therapeutic Management and Effect of PharmacistIntervention on Children with Asthma2 1 1 3Ramesh A , Satyanarayana V* , Rajani M , Rajani V1Department of Pharmacy Practice, Sri Venkateshwara College of Pharmacy, Hyderabad, A.P, India.2Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Andhra Pradesh3Vel's College of Pharmacy, Chennai, T.NA B S T R A C TSubmitted: 16/10/2011Accepted: 9/11/2011Asthma is an inflammatory airways disease caused by a complex interaction between host susceptibility (genetics) and diverse environmental1factors. It is apparent from ongoing research that no single susceptibility gene confers a major risk for this disease . In a large number of cases, itcan be well managed. In addition to accurate diagnosis, appropriate therapy and control of environment factors, a good educational program isrequired which has not yet received due attention. Prompted by the fact that a large number of asthmatic children and their parents lack sufficient2knowledge about asthma . The aim of the present study was carried out to evaluate the impact of a therapeutic management and effect ofststpharmacist intervention on children with asthma. The study was conducted for a period of 6 months from 1 November 2010 to 31 April 2011.This study was conducted in the Gandhi general hospital, Hyderabad, Pediatric unit has five units distributed into two wards, each unitconsisting of 30 beds total of 150 beds, providing specialized health care service to all strata of people in A.P,India. This was a prospective andobservational study and was approved by IRB. A total of 100 patients were enrolled in the present study during the study period. Out of the 60(60%) were males and 40 (40%) were female patients. Total distribution of patients with respect to age group showed that highest number ofpatients was found in the age group of 1-3 years (40%) and least was found between 11-12 years age group (2%). During pre-intervention periodnumber of irrational prescribing reported was 161, but after intervention it was significantly reduced to 93.Keywords: Children, Asthma, Intervention, Pharmacotherapy.INTRODUCTIONAsthma is a chronic inflammatory disorder of the airways.Chronically inflamed airways are hyperresponsive, theybecome obstructed and limit the airflow (bybronchoconstriction, mucus plugs, and increasedinflammation) when airways are exposed to various risk3factors . With approximately 300 million persons currentlysuffering from asthma worldwide, this condition is one of the4, 5most common chronic diseases, especially in childhood .Asthma can be effectively treated and most patients canachieve good control of their disease. When asthma is undercontrol children can: avoid troublesome symptoms night andday, use little or no reliever medication, have productive,physically active lives, have normal lung function and avoidserious attacks. Asthma causes recurring episodes ofAddress for Correspondence:Satyanarayana V, Department of Pharmacy Practice, Sri VenkateshwaraCollege Of Pharmacy, Hyderabad, A.P, India.E-mail: rajanisvcp@gmail.comwheezing, breathlessness, chest tightness and coughing,particularly at night or in the early morning. Asthma attacks(or exacerbations) are episodic, but airway inflammation is6chronically present .Asthma is a major cause of chronic morbidity and mortalitythroughout the world and there is evidence that its prevalencehas increased considerably over the past 20 years, especiallyin children. The prevalence of asthma symptoms in childrenvaries from 1 to more than 30 % in different populations and isincreasing in most countries, especially among young7children . Mean worldwide current wheeze prevalence ratesin the last 12 months range from 11.6% in 6-7 years agechildren to 13.7% in 13-14 years olds, according to Phase III8of the international study of asthma and allergies in children .In a large number of cases, it can be well managed. In additionto accurate of environmental factors, a good educationalprogram is required, which has not yet received due attention.Prompted by the fact that a large number of asthmatic children2and their parents lack sufficient knowledge about asthma .Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 39

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with AsthmaCurrently, asthma affects approximately 15 millionindividuals in the United States. On an annual basis, 5,000deaths, 500,000 hospitalizations, and 2 million emergency9, 10, 11department visits are attributed to asthma . Asthmacontinues to be under – diagnosed and under – treated, itsappropriate management requires correct diagnosis,assessment of severity, proper management includingappropriate follow-up, and specialty referral whereappropriate. The guidelines for treatment of asthmarecommend greater involvement of the patients in the12, 13management of their diseases .According to the National Heart, Lung and Blood Institutes(NHLBI) current guidelines, asthma treatment entails amultilevel intervention including appropriatepharmacological therapy, patient education, control ofasthma triggers, and monitoring of asthma severity with13objective measures of lung function . Collaborativeapproach between patient and pharmacist may improvepatient medication adherence behavior and therapeuticoutcomes. Role of pharmacist as asthma educator isappreciated worldwide in reducing the risk factors and14improving patient knowledge . The role of pharmacist inpatient education and evaluation of therapy is taking no morerelevance every day. Their knowledge of drug therapy makesthem the appropriate professional to instruct and educate thepatient on the correct use of medications. For many years,pharmacists have been taking an active role not only in theeducation of the patient, but also in the monitoring andevaluation of therapy, and detecting potential problems (adverse – reactions and interactions, therapy failures, nonadherenceto treatment, duplication of therapy, etc.) that15, 16, 17directly affect the quality of life of the patients .Pharmaceutical care practice is intended to meet a need in thehealth care system that has arisen due to the increase incomplexity of drug therapy and the significant level of drug –18related morbidity and mortality associated with drug use .Therefore, the introduction of pharmaceutical care is requiredin developing countries to aid in the resolution of medication– related problems. The existence of variations inpharmaceutical care models and practices among countries19were also reported .Medicine use is rational (appropriate, proper, correct) whenpatients receive the appropriate medicines, in doses that meettheir own individual requirements, for an adequate period of20time, and at the lowest cost both to them and the community .Irrational (inappropriate, improper, incorrect) use ofmedicines is when one or more of these conditions are notmet. Worldwide, it is estimated that over half of all medicines21, 22are prescribed, dispensed or sold inappropriately .Moreover, it has been estimated that half of all patients fail to23take their medication as prescribed or dispensed . Irrationaluse may take many different forms, for example,polypharmacy, over-use of antibiotics and injections, failureto prescribe in accordance with clinical guidelines andinappropriate self-medication. However, despite the globalproblem of inappropriate use, few countries are monitoringmedicines use or taking sufficient action to correct the24situation . Thus the purpose of the study is to conduct adetailed prospective study about to evaluate the impact of atherapeutic management and effect of pharmacistintervention on children with asthma. The present study wasconducted with the following objectives:-1. To study the current line of therapeutic managementfollowed in the department of pediatrics in the Gandhigeneral hospital, Hyderabad, Pediatric unit has five unitsdistributed into two wards, each unit consisting of 30beds total of 150 beds, providing specialized health careservice to all strata of people in A.P.2. To compare this with standard treatment guidelines.3. To find the impact of counseling in patients withbronchial asthma and their parents.4. To educate the patient and parents regarding the healthcondition and importance of life style modification.5. To promote rational use of drugs.MATERIAL AND METHODSStudy Design: This study was a prospective, observational,interventional study consisting of 100 patients with bronchialasthma. Following prescription analysis patients areevaluated about therapeutic management of asthma inchildren's.Study Site: This study was conducted in the Gandhi Hospital,paediatric unit has five units distributed in two wards, eachunit consisting of 30 beds total of 150 beds, providingspecialized health care service to all strata of people in anAndhra Pradesh.Duration: This study was conducted for a period of 6 monthsststfrom 1 November 2010 to 31 April 2011Study Criteria:Ø Inclusion Criteria:· Patients with history of bronchial asthma in the age groupof 1 to 12 yrs.· Patients and their parents willing to give their informedconsent to participate in the studyIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 40

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with AsthmaØ Exclusion Criteria· Patients associated with another diseases like cardiacproblem, liver diseases, Central nervous system diseases.Intervention study: The present study was mainly dividedinto two parts for pointing out the deviations from standardtreatment guidelines for promoting rational use of drugs in thepediatric units of Gandhi hospital.1. Pre-intervention data.2. Pot-intervention data.ANOVA test was carried out 50 case sheets were randomlycollected to generate pre intervention data for planning anintervention data. For post intervention data 50 case sheetswere collected and analyzed.The following method is followed for intervention.1. Review of medication orders everyday in pediatricwards.2. Comparison of medication orders with standardtreatment guidelines.3. Detection and verification of medication errors byreferring unbiased reference resources ( Micheal T.Respp et al., 1992; De varies et al., 1994; Michael R.Cohen, 1999; Dinesh K. Mehta, 2001; AFHS DrugInformation, 2001; Government of India, 2002;Sangeetha Sharma et al., 2005.4. Critical examination of medication order for examining– excessive use of drugs, over use of antibiotics andexcessive injection practice.5. Assurance of the revised medication order inconsultation with prescriber.6. Documentation of findings.The case records of patients were examined for details ofprescription, to fill the data collection form. The doctors onduty/ concerned pediatrician were consulted for clarificationwhenever required.The study procedure:Ø Patient enrollment: The patient who has been diagnosedas bronchial asthmatic was sent to the clinical pharmacist bythe doctors. About 100 patients , who are satisfying studycriteria were included in the study to assess patientknowledge.Ø Collection of data: Patient data collection form includeddemographic details, co- morbid condition, past medical andpast medication history, family history, life style, laboratorydetail etc.Measuring knowledge, attitude and practice onmanagement of bronchial asthma:Patient knowledge about bronchial asthma was assessed byusing patient knowledge attitude and practice questionnaire.This questionnaire assesses the patient basic knowledgeabout bronchial asthma, its risk factors, completion andlifestyle modification necessary in bronchial asthma patient.All the questions were closed ended questions. Thisquestionnaire contains 15 scored questionnaire andmaximum score was 15 higher score indicate a greaterknowledge.An intervention based randomized study was designed toevaluate the effect of patient counseling in the studypopulation.All the bronchial asthma patient who were meeting inclusioncriteria and admitted in inpatient ward were included in thestudy after getting consent from patient and by standers.Patients were randomized as control and study group. Total ofabout 100 completed the study, out of that 50 were in studygroup and 48 in the control group. Two patients in the controlgroup didn't complete the study because patients wereimmediately shifted from the hospital. The base lineknowledge was measured using patient knowledge, attitudeand practice assessment questionnaire. The study group wasprovided with written and verbal information about bronchialasthma and its management by clinical pharmacist aftertaking baseline knowledge. On an average 30-45 minutes wasspend with each patient depending on their education leveland understanding capability. To the control group noinformation was provided by the clinical pharmacist.On the day of discharge the same knowledge attitude andpractice assessment questionnaire was administered againand patient knowledge was assessed about bronchial asthmain both groups. The base line and final knowledge aboutbronchial asthma was compared in both control and studygroup.Statistics:Ø Statistical Methods:Student test (paired) has been used tofind the significance of total answers (correct) between beforeand after intervention. Effect size due to cohen (d) has beenused to find the effect of intervention. Difference ofpercentage (Before-After) are computed using on-line javascripttests on difference (Before-After test on proportion).Ø Effect Size:No effectMild effectd

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with AsthmaModerate effectLarge effectVery Large effect0.50

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with Asthmathe mild intermittent category, 24% were in mild persistentand 10% were in moderate persistent category. Severepersistent cases had not been reported during the study period(Figure 2). Among infants, 20% have wheezing with onlyupper respiratory tract infections (URTIs), and 60% no longerhave wheezing by age 6 years. As Martinez et al have pointedout; however, many of these children are "transient wheezes"whose symptoms subside during the preschool or early school30, 31years . They tend to have no allergies, although their lungfunction is often abnormal. These findings have led to the ideathat they have small lungs.Fig. 2: Saverity of AsthmaSeverity of asthma is categorized based on the NAEPP(National Asthma Education and Prevention Programme) guidelinesIn the present study 50 prescriptions are analyzed before theintervention, and based in the data collected in the preintervention period an intervention strategy was designed inconsultation with clinical staff of the department. As a part ofintervention strategy interpersonal communication wasimproved, the seminars are arranged to detail on drug useproblems based on the pre intervention data. The clinical staffis impressed upon the need of improving where evernecessary to promote rational drug use and minimize drug useproblems. In post intervention period again 50 prescriptionsare examined and the full data are analyzed statistically.Number of drugs prescribed in the pre intervention study was330 and 283 in the post intervention study. Finding of theresult indicates there is no significant reduction in the numberof drugs prescribed. It has reported that average number ofdrugs prescribed per prescriptions is 6 in both pre interventionand post intervention studies. During pre intervention periodnumber of drugs prescribed in generics is 220 where as in postintervention period it is 227. However there is no significantin post intervention period. During pre intervention periodnumber of tablets prescribed is 110 reduced to 74 in postintervention period. (Table No 3 & Figure 3).We have observed that there is no significant improvement inthe number of nebulizers, cough syrups and oxygenTable 3: Prescription Analysis (I) by pre-intervention andpost-intervention dataPrescriptions Analysis Pre Postintervention interventionTotal number of prescriptions 50 50analysedTotal number of drugs prescribed 330 283Average number of drugs per 6 6prescriptionsNumber of drugs prescribed bed in 220 227genericsPercentage of drugs prescribed in 440 454genericsNumber of antibiotics prescribed 100 92Percentage of antibiotics prescribed 200 193Number of injections prescribed 110 74Percentage of tablet to prescribed 220 148Number of neublization prescribed 100 100Percentage of neublization prescribed 100 100Number of cough syrups prescribed 22 19Percentage of cough syrups prescribed 44 38Number of O2inhalation prescribed 50 50Percentage of O inhalation prescribed 100 1002Number of irrational prescribed 161 93Fig. 3: Prescription Analysis (I) by pre-intervention andpost-intervention dataprescribed between pre intervention and post interventionstudies. During pre intervention period number of irrationalprescribing reported was 161, but after intervention it wassignificantly reduced to 93. (Table No 4 & Figure 4).Naeti Suksomboon et al concluded that there was a significantdecreased in the number of drug related problems in the activeIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 43

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with AsthmaTable 4: Prescription Analysis (II) by pre-intervention and post-intervention dataArea of Pre- Post- F-test t-test ResultIntervention Intervention Intervention (p>0.05) (95%(n=50) (n=50) C.I)Number of drugs 330 283 0.5775 1.12 to1.37 NSNumber of drugs prescribed in generics 220 227 0.4421 1.21 to 1.55 NSNumber of antibiotics 100 92 0.3021 1.38 to 1.44 NSNumber of Tablets 110 74 0.0274 1.22 to 1.66 NSNumber of Nebulizations 100 100 0.5141 1.11 to o.99 NSNumber of Cough syrups 22 19 0.2412 0.21 to 0.14 NSNumber of Oxygen inhalations 50 50 0.2141 0.12 to 0.11 NSNumber of Irrational prescribing 161 93 9.22 0.87 to 0.66 SANOVA: Degree of freedom =49; Table value of F-test=3.76 at 95% confidence limits, N/S =Not Significant;S=Significant. No. of irrational prescribed – is determined based on WHOFig. 3: Prescription Analysis (iI) by pre-intervention andpost-intervention datagroup compared to the control group. The data suggest thathaving pharmacists provide pharmaceutical care for pediatric32patients with asthma results in a favorable outcome .Lincy SL described that pediatric pharmaceutical care is still anew concept in the pharmacy profession. In an effort to rectifythis situation metered-dose inhaler technique, to determinefrequency of MDI assessment and teaching behavior and toassess the effect of asthma pharmaceutical care educational33programmers .D Barbanel et al; 2003, was undertaken a randomizedcontrolled study to determine whether a communitypharmacist could improve asthma control using selfmanagementadvice for individuals recruited during34attendance at a community pharmacy .Koffi N. et.at, conducted study to assess the role ofpharmacists in management of asthma in Africa. Thisquestionnaire survey was conducted. Participation rate was88.69%. In case of acute episodes, care is provided by thepharmacists in 59.80% of the cases. Aerosol devices are mostwidely used. For chronic care corticosteroids are widely35delivered .Christine et at; 2005 conducted a study to measure the effectof an asthma intervention on the functional status andmorbidity of children with undiagnosed asthma by using datafrom a randomized trial to compare outcomes at baseline andfollow-up for children with undiagnosed and diagnosedasthma. They studied 510 symptomatic children withdiagnosed asthma (diagnosed) and 299 children withsymptoms but no diagnosis (undiagnosed). Children withundiagnosed asthma were generally Nona topic, althoughsome had symptoms at a level comparable to children with adiagnosis. The intervention successfully improved functional36status as well as for children with diagnosed asthma . In mostof those studies, compared with usual care, school-basedasthma education improved knowledge of asthma (7 of 10studies), self-efficacy (6 of 8 studies), and self-managementbehaviors (7 of 8 studies). Fewer studies reported favorableeffects on quality of life (4 of 8 studies), days of symptoms (5of 11 studies), nights with symptoms (2 of 4 studies), and37school absences (5 of 17 studies) .Inferences from the patient knowledge, attitude andpractice questionnaire (Study group and Control Group)In our study it was observed that the active involvement ofpharmacist in healthcare team can improve patient'sknowledge, attitude and practice on management of bronchialasthma. For that we conducted an intervention based study,revealed that patients in study group improve their knowledgesignificantly after single education meeting with pharmacist.It was found that the mean knowledge score increased from7.47 to 21.87 in study group after the intervention (i.eCounseling by clinical pharmacist). Out of 15 questions 7individual questions improved significantly in study group.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 44

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with AsthmaStudy GroupOut of 50 patients, 24% were aware of the fact that they arehaving bronchial asthma. 25% were unaware about theirdisease and are of opinion that they are having some problemslike allergy, oesinophilia or bronchitis occurring occasionallyor regularly. After counseling 52% could name their disease.Before counseling 4% of the patients were properly awarethat asthma is a disease of the airways in the lungs. Aftercounseling 12% of the patients could answer correctly.Before counseling 28% of the patients were aware of the factthat the asthma attack is occurring after exposure to asthmatrigger factors like smoke, dust and cold items. Aftercounseling 62% of the patients had the opinion that apart fromtaking medicines, controlling of asthma trigger is alsoimportant for proper maintenance of therapy. So as a patientcounselor I could advice about the importance of avoidingasthma triggers.Before counseling 36% of the patients were known about thesymptoms of asthma such as cough and breathlessness. Aftercounseling 72% of the patients could answer all the symptomsof asthma attack. Before counseling none of the patients wereknown about the drugs to be avoided in asthma. Aftercounseling with the help of patient information leaflets 12 %of the patients could answer the medications to be avoided inasthma. Out of 50% patients 4% told they prefer aerosoltherapy. None of the patients prefer administering injections.Most of the patients were willing to take oral medicationrather than any other medications. In that maximum patientslike to take syrups and tablets. When patients were educatedabout the proper use of aerosol therapy and its advantage withlesser adverse effects, 30% of patients were willing to takeaerosol therapy rather than any other formulation. Beforeintervention 32% of the patients were aware about the fooditems to be avoided in asthma. After counseling 80% of thepatients could answer about the food items to be avoided inasthma. Before counseling 12 % patients were aware aboutthe importance of taking regular treatment of bronchialasthma. After counseling 78% was aware about importance oftaking regular treatment of bronchial asthma. Beforecounseling 100% of the patients were failed to identify thedrug properly. After counseling 14% of the patients wereproperly aware about the use of the drugs that have beenprescribed to them and remaining had some confusion withthe medications. Before counseling 100% of the patients hadan opinion that they will take the medication as per theprescription and if they cured, then no need of administeringthe same drugs. But after counseling 40% of the patients werechanged their opinion and decided to take treatment as perdoctor's and pharmacist's advice. Before counseling 12% ofthe patients were aware about the proper use of inhalertechniques. They got this knowledge from counseling 48% ofthe patients got idea regarding proper inhalation techniques.6% were aware about the management of severe or acuteasthma. They got this knowledge from doctors, pharmacists,nurses or might have used earlier. After counseling 24% gotthe proper ides regarding severe or acute asthmamanagement. Before intervention 6% of patients reportedthey experienced taste disturbances and tremor. Beforecounseling 44% of patients told they are satisfied to someextent. After counseling 88% of patients were completelysatisfied with the medication and 12% of the patients are not atall satisfied with the prescribed medication.In the study group out of 15 questions 7 questions showedsignificant improvement. The total effect was very large witheffect size (d) = 4.12 and P> 0.001. It was found that the meanknowledge increase from 7.47 to 21.87 in study group.(Table5).Control GroupEven though some questions showed improvement becauseof hospital stay, there is no significant improvement in controlgroup. It found that the mean knowledge score increase from7.87 to 8.8 in control group. It was found that intervention is3.25 times more effective in study group when compared tocontrol group. (Table 6)CONCLUSIONPresent study was done in pediatric division Gandhi Collegeand hospital, 1200 bedded multispecialty tertiary careteaching hospital.Findings of the project indicate a significant reduction inirrational prescribing which includes overdose, wrongduration, wrong frequency and multiple prescribing.However, though there was a reduction in number ofantibiotics, tablets, cough syrups and increase in genericprescribing in post intervention period, the data are notstatistically significant.Standard treatment guidelines for bronchial asthma weresupplied to all the doctors of paediatric division. A suggestionwas made to study the drug use problems in more detail andeducational, managerial, and legal investigation can beplanned to decrease drug use problems and promote rationaluses drugs.Besides assuring safe medication, the study has createdawareness among the medical practitioners on the necessityof clinical pharmacist in institutional healthcare setup toprevent irrational prescribing and to promote rational use ofdrugs.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 45

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with AsthmaTable 5: Intervention study (Study Group) - Knowledge, attitude and practice assessment in study group before and after intervention.(Assessed Based on Correct Answers)Questions (n=50)Before After % P-ValueIntervention Intervention DifferenceNo % No %Can you name the disease you are suffering from? 12 24 26 52 28 0.001**Do you know which part of your body is affected? 2 4 6 12 8 0.1321Do you know what are the causative/ worsening 14 28 31 62 34 0.0039**factors of asthma are?Do you know what the symptoms of asthma are? 18 36 36 72 36 0.000**Do you know how important to avoid allergens? 8 16 17 34 18 0.2124Do you know which dosage form is good for you? 2 4 15 30 26 0.1141Can you list out the drugs are to be avoided in 0 0 6 12 12 0.1321asthma patients?Do you know about that food items to be avoided 16 32 40 80 48 0.0036**in asthma?Do you know how to manage during a severe or 3 6 12 24 18 0.0914acute asthma attack?Do you know the importance of taking regular 6 12 39 78 66 0.005*treatment for asthma?Can you identify the drugs you are taking? 0 0 7 14 14 0.0042**Do you know how long the medication for 0 0 20 40 40 0.0214*asthma should be taken?Do you know how to use an inhaler? 6 12 24 48 36 0.1414Do you know about the side effects of the 3 6 5 10 4 0.2141drugs you are taking?Are you satisfied with the way of your medication controls 22 44 44 88 44 0.1211your symptoms such as cough or shortness breath?Total corrected answers (Mean ± SD) 7.47 ± 4.21 21.87 ± 13.62 28.80 P

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with AsthmaTable 6: Intervention study (Control Group) - Knowledge, attitude and practice assessment in study group beforeand after intervention. (Assessed Based on Correct Answers)Questions (n=48)Before After % P-ValueIntervention Intervention DifferenceNo % No %Can you name the disease you are suffering from? 13 27.08 14 29.16 2.08 0.083Do you know which part of your body is affected? 0 0 2 4.16 4016 0.532Do you know what are the causative/ worsening factors 12 25 16 33.33 8.33 0.083of asthma are?Do you know what the symptoms of asthma are? 19 39.58 22 45.83 6.25 0.193Do you know how important to avoid allergens? 7 14.58 8 16.66 2.08 0.334Do you know which dosage form is good for you? 3 6.25 3 6.25 0 0.137Can you list out the drugs are to be avoided in asthma 1 2.08 1 2.08 0 0.095patients?Do you know about that food items to be avoided 6 12.5 6 12.5 0 0.168in asthma?Do you know how to manage during a severe or acute 12 25 14 29.16 4.16 0.083asthma attack?Do you know the importance of taking regular 6 12.5 8 16.66 4.16 0.334treatment for asthma?Can you identify the drugs you are taking? 2 4.16 3 6.25 2.09 0.074Do you know how long the medication for asthma 1 2.08 3 6.25 4.17 0.702should be taken?Do you know how to use an inhaler? 6 12.5 7 14.58 2.08 0.064Do you know about the side effects of the drugs 3 6.25 4 8.33 2.08 0.839you are taking?15. Are you satisfied with the way of your medication 22 45.83 23 47.91 2.08 0.132controls your symptoms such as cough or shortness breath?Total corrected answers (Mean ± SD) 7.87 ± 3.906 8.8 ± 5.829 0.948 P>0.001Statistical Methods: Paired ‘ t ’ and paired proportion test. Effect size: (d) Mild Effect (0.45)REFERENCES1. Howard T.D, Meyers D.A, and Bleecker E.R . Mappingsusceptibility genes for allergic disease. Chest 2003; 123(3):S363-68.2. Biserka cical, Eva Verona, et al. An individualized approach inthe education of asthmatic children. Acta Clin Crot, 2008;Vol.47(4): 231-38.3. Asher MI, Keil U , Anderson HR, Beasley R, et al. Internationalstudy of asthma and allergies in childhood (ISAAC): rationaleand methods. Eur Respir Jour. 1995; 8(3):483-91.4. Masoli Moosapet, Fabian D, Holt S, Beasley R. The globalburden of asthma: executive summary of the GINADissemination committee report I. Allergy 2004; 59:469-78.5. Marijke M, Tibosch, Christianne Moosapet, Verhoak, et al.Psychological characteristics associated with the onset andcourse of asthma in children and adolescents: A systematicreview of longitudinal effects. Pt. education and counseling2011; 88:11- 19.6. Global initiative for asthma. Global strategy for asthmamanagement and prevention, revised 2006. Available fromhttp:// www.ginasthma.com/GuidelinesResources.asp.7. Stewart AW, et al; ISAAC steering committee. Internationalstudy for asthma and allergy in childhood. The relationship ofper capita gross national product to the prevalence ofsymptoms of asthma and other atopic diseases in children(ISAAC). Int J Epidemiol, 2001; 30(1):173-179.8. Pearce N, et al. Worldwide trends in the prevalence of asthmasymptoms: Phase III of the international study of asthma andallergies in childhood (ISAAC). Thorax 2007; 62: 758-66.9. Mannino DM, Homa DM, et al. Surveillance for asthma – Unitedstates, 1980- 1999, MMWR 2002; 51:1-13.10. American Lung Association. Trends in asthma morbidity andmortality. Available:.11. Hall MJ, Owings MF. 2000 National Hospital Discharge Survey.Advance data from Vital and Health Statistics, No-329.Hyattsville MD, National Center for Health Statistics, 2002.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 47

Satyanarayana V - Evaluation of the Impact of a Therapeutic Management and Effect of Pharmacist Intervention on Children with Asthma12. Elkhansa Abdelhamid, et al. Evaluation of a hospital pharmacybasedpharmaceutical care services for asthma patients.Pharmacy Practice (Internet) 2008; 6(1).13. National Asthma education and prevention program.Guidelines for the diagnosis and management of asthma,expert panel Report II (Publ no. 97-405). Bethesda, Maryland:National Institutes of Health, National Heart, Lung, and BloodInstitute, 1997.14. V. Ramanarayana Reddy, et al. A Clinical study on therapeuticmanagement and impact of patient counseling on asthmapatients. Int J Res Pharm Sci, 2011; 2(1):8 -11.15. Pauley TR, Magee MJ, et al. Pharmacist managed, physiciandirected asthma management program reduces emergencydepartment visits. Ann Pharmacother 1995; 29:5–9.16. Hunter KA, et al . Pharmacist provided education andcounseling for management of pediatric asthma. Patient EducCouns 1994; 24: 127-34.17. Botha JH, Tyrmes I, et al. Pharmacokinetics consultationprogram in a pediatric asthma clinic. Am J Hosp Pharm, 1992;49:1936- 40.18. Berenguer B, La Cassa C, et al. Pharmaceutical Care: Past,Present and Future. Curr Pharm Des 2004; 10(31): 3931–46.19. Farris KB, Fernandez L limos F, et al. Pharmaceutical care incommunity pharmacies: Practice and research from around theworld. Ann Pharmacother, 2005; 39:539-41.20. The rational use of drugs. Report of the Conference of Experts.Geneva, World Health Organization, 1985.21. Promoting rational use of medicines: Core components. WHOPolicy Perspectives on Medicines, No.5. Geneva, World HealthO r g a n i z a t i o n , 2 0 0 2 . A v a i l a b l e a t :http://apps.who.int/medicinedocs/pdf/h3011e/h3011e.pdf22. Medicines use in primary care in developing and transitionalcountries: Fact book summarizing results from studies reportedbetween 1990 and 2006. Geneva, World Health Organization,2009. Available at: http://www.who.int/medicines/publications/primary_care_8April09.pdf23. Sabaté E. Adherence to long-term therapies. Evidence foraction. Geneva, World Health Organization, 2003.24. Using indicators to measure country pharmaceutical situations:Fact book on WHO Level I and Level II monitoring indicators.Geneva, World Health Organization, 2006. Available at:http://apps.who.int/medicinedocs/index/assoc/s14101e/s14101e.pdf.25. The society of hospital pharmacist of Australia, SHPA standardsof practice for clinical pharmacy 1996, 2-14.26. Strand L.M, Morley P.C, Cipolle R.T, Ramsey R, Lamsam G.D.Drug – related problems: their structure and function. DICP1990; 24(11):1093-7.27. Global strategy for asthma management and prevention.Global initiative for asthma (GINA) 2006. Available athttp://ginasthma.org.28. Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status ofchildhood asthma in the United States, 1980-2007. Pediatrics.Mar 2009;123 Suppl 3:S131-45.29. Farah CS, Kermode JA, Downie SR, et al. Obesity is adeterminant of asthma control independent of inflammation andlung mechanics. Chest. Sep 2011; 140(3):659-66.30. Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M,Morgan WJ. Asthma and wheezing in the first six years of life.The Group Health Medical Associates. N Engl J Med. Jan 191995;332(3):133-8.31. Castro-Rodríguez JA, Holberg CJ, Wright AL, Martinez FD. Aclinical index to define risk of asthma in young children withrecurrent wheezing. Am J Respir Crit Care Med. Oct2000;162(4 Pt 1):1403-632. Naeti Suksomboom, Watinee Petchudomsinsuk et al, Impact ofPharmacist Intervention in Pediatric Asthma Patients: ARandomized Controlled Trial 2003: 30(2).33. Lincy SL. Paeditrics pharmaceutical care as a new concept inthe pharmacy profession www.lip.org.34. Barbanel .d, Eldridge .s et al , can self management programmedelivered by a community pharmacist improve asthma control .Throx 2003; 58:851-54.35. Koffi N, Thomas Rock et al. Role of pharmacist in managementof asthma in Africa. Parmaceutical journal 1995; 242.36. Christine C, Joseph M et al Effect of asthma intervention onchildren with undiagnosed asthma. J .Paediatrics 2005;146:96-104.37. Coffman JM, Cabana MD, Yelin EH. Do school-based asthmaeducation programs improve self-management and healthoutcomes?. Pediatrics. Aug 2009; 124(2):729-42. .Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 48

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaEvaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients inNepal: A Preliminary Study1, 2 3 4 5Dinesh K.U* , Mohamed Izham M.I ,Alurkar V.M , Pranaya M1 2Department of Hospital and Clinical Pharmacy, Department of Pharmacology, Manipal Teaching Hospital / Manipal College of MedicalSciences, Pokhara, Nepal3College of Pharmacy, Qatar University, Doha, Qatar,4Department of Medicine, Manipal College of Medical Sciences/Manipal Teaching Hospital, Pokhara, Nepal5Department of Pharmacology, College of Medical Sciences, Chitwan, Bharatpur, NepalA B S T R A C TSubmitted: 2/11/2011Accepted: 19/11/20114Diabetes is a chronic disease condition characterized by hyperglycemia, which if uncontrolled leads to various short terms and long termcomplications. The prevalence rate of diabetes is high in Nepal and is expected to rise. This rise is due to low literacy rate, lack of publicawareness, lack of advanced healthcare facilities and sedentary life style. The contribution of pharmacists in diabetes management is so far notdocumented in Nepal. The aim of this preliminary study was to assess the knowledge, attitude and practice of diabetics, drug prescribingpattern, and the impact of pharmaceutical care program on glycemic control, direct cost involvement and patient satisfaction. The study wasprospective and interventional, in which newly diagnosed diabetes patients were enrolled. They were evaluated for their diabetes Knowledge,Attitude and Practice (KAP), and satisfaction level by administering the KAP and satisfaction questionnaires at baseline and after two monthspost intervention. The enrolled patients were divided in three groups, control group (n=10), test group-1 (n=11) and test group-2 (n=10). Thecontrol group patients went through their normal care . Both the intervention groups (test group-1 and test group-2) received pharmaceuticalcare emphasized on education and counseling about diabetes, importance of medication used and were provided with diabetes booklet, dietchart, medication calendar, while demonstration of diabetic kit was specially to test group-2 patients only. Total 31 patients were enrolled [maleswere 22 (70.96%)]. Large number of patients were in the age group of 51-60 years (n=11, 35.48%). Commonly prescribed drug class wasantidiabetics (n=36, 48%). Biguanides were commonly prescribed drug category accounting for 17 (47.22%) of the total antidiabetics.Significant improvement in blood glucose level was observed in test group patients in terms of knowledge (score of 7.112.32), attitude (score of14.77±3.23) and practice (score of 9±1.65 check decimal point) after intervention. The overall improvement in KAP scores were foundinsignificant in all the three group patients (P=0.012). Direct cost reduction was noted in all the three groups during their two months studyperiod. The satisfaction level was found significantly higher (P=0.008) in test group-2 patient among the three groups. Present study has showna positive impact of pharmaceutical care program among diabetics in terms of their KAP improvement. Improvement in the glycemic control andreduction in the prescription cost and economical burden was found after such program which increased the overall patients' satisfaction.Keywords: Diabetes mellitus, Direct cost, Drug prescribing pattern, KAP, Nepal, Pharmaceutical care, Satisfaction.INTRODUCTIONDiabetes is a chronic disease condition characterized by1hyperglycemia. In diabetes there is an increased insulindemand and reduction of insulin secretion in the body. Thisleads to abnormal carbohydrate, protein and lipid2metabolism. It is one of the most common chronic diseaseAddress for Correspondence:Dinesh K Upadhyay, Assistant Professor, Department of Pharmacology /Hospital and Clinical Pharmacy, Manipal College of Medical Sciences/ ManipalTeaching Hospital, Pokhara, Nepal.E-mail: dinesh17dec@rediffmail.com3condition seen in primary care. Diabetes causes disability,premature mortality, loss of productivity and increaseddemand of healthcare facilities. The prevalence rates ofdiabetes type-2 is rising much higher than type-1 and have4affected 6% of people between the age group of 20-79 years.Diabetes if uncontrolled can lead to microvascular andmacrovascular complications which can affect the patients'5, 6quality of life and lead to morbidity and mortalityThe management of type-1 depends upon insulin therapy andtype-2 diabetes is treated by oral hypoglycemic agents7(OHAs). The treatment of long term complications likeIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 49

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary Study2hypertension, hyperlipidemia and ischemic heart disease indiabetics also required to prescribe large number of drugs forthese patients life long. The long term complications can becontrolled only if the patient maintains their tight glycemic8control by following advice provided by healthcareprofessionals. Pharmacist can play an important role in9patient counseling and education program of diabetics. Thepatients' satisfaction can be increased only if their healthrelated problems can be minimized by providing proper careto them by healthcare professionals.Diabetes increase the economy burden and reduces patients'10productivity. Disease awareness in a population is the cornerstone to formulate the strategy to decrease the prevalence rateof diabetes. Organizing counseling and educational programis the first step to increase the awareness and alertness in thepatients for the disease and reduce the risk of long termcomplications. This may lead to less prescription cost andreduces the economy burden to the patient.A large number of research have been done in counseling and11,12education of diabetics. Proper counseling and educationcan improve patients knowledge about diabetes and increase13attitude and practice. Knowledge and information can helppeople to assess their risk of diabetes and inspire them to take14charge of their disease. A study from Kenya had identified aserious deficiency of knowledge about diabetes among the15diabetes patients. Another study from Nepal stated thatproper knowledge and care management program canimprove the patient outcomes and prevent the early stage of16complications. A study done from India stated that propercounseling and education improves patient's perceptions,17attitudes and practices regarding diabetes.Nepal is a developing country in South Asia with a significantburden of diabetes. It is estimated that the diabetes burden in18Nepal will be increased up to 6,38,000 by the year 2025. Thestrong reason behind increased percentage of diabetes inNepal is low literacy rate, lack of public awareness, lack ofalertness and understanding for diabetes, lack of advancedhealthcare facilities, low socioeconomic status and sedentary5life style. These factors may increase the diabetes incidencein the country which may lead prescription overload and19irrational drug prescribing.Hence, this preliminary study was conducted to identify theimpact of pharmaceutical care program among diabetics andits effect on KAP outcomes, patients' glycemic control, drugprescribing pattern, and effect on patients' economy burdenand satisfaction.OBJECTIVES:The present study was carried out with the followingobjectives:1. To study the demographic details of newly diagnoseddiabetes patients enrolled in study.2. To evaluate the patients' knowledge, attitude and practiceabout diabetes.3. To study the pattern of drug prescribing among diabeticpatients.4. To study the impact of pharmaceutical care program onglycemic control of the study subjects.5. To study the direct cost incurred by diabetics in diabetesmanagement.6. To evaluate the patient satisfaction on the pharmaceuticalcare provided to them.METHODOLOGYStudy design: This study was a prospective, interventional,follow up study where the newly diagnosed diabetic patientsstwere enrolled in the study during their 1 day of hospital visitto the Medicine Department. The patients were divided intothree groups [Control group (CG), Test group-1(TG-1) andTest group-2 (TG-2)] on the basis of 1 to 1 enrollment method.The control group patients were on the normal care, while thetest group-1 and test group-2 patients were on pharmaceuticalcare apart from normal care given by the clinicians. Eachpatient was followed for two months during their treatmentschedule.Consent form: This form was prepared to get the writtenconsent from patients before enrolling them in the study. Thisform was prepared in English and translated into local Nepalilanguage.Study site: The study was carried out in medicationcounseling center (for out patients) and at the bed side forhospitalized patients in medicine ward, Manipal TeachingHospital (MTH), Phulbari, Pokhara, Nepal. MTH is an 825bedded multidisciplinary private tertiary care teachinghospital of Manipal College of Medical Sciences located inwestern region of Nepal with average bed occupancy of about250 patients and an average out patient flow of about 450 perday. The hospital consists of both clinical and non-clinicalspecialty departments. Manipal College of Medical Sciencesthhas been included in the 7 WHO lists of hospitals in thedeveloping world. The hospital provides healthcare service topatients of western and mid western region of Nepal.Study duration: This preliminary study was carried out forthe duration of six months from February 2009 to July 2009 atManipal Teaching Hospital.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 50

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyStudy sample: Total 31 patients were enrolled during thestudy period. They were divided into three groups (controlgroup=10, test group-1=11 and test group-2=10) on the basisof 1 to 1 enrollment method.Inclusion and exclusion criteria: Newly diagnosed diabetespatients at MTH and visited to the medicine department of thehospital during the study period were included in the study.Both out patients and in-patient were included in the study.Only new diabetic cases were enrolled in the study to validatethe methodology. Pregnant, mentally incompetent andimmunocompromised patients were excluded in the study.The patients who were not interested in taking part in thestudy were also excluded.STUDY TOOLS:I) Sociodemography form: The aim for preparing this formwas to have patient sociodemography in details like name,age, gender etc. This form was first prepared in English andtranslated into local Nepali language.ii) Lab investigation documentation form: This form wasprepared to have all the clinical investigation details of thediabetes patients done on their first day visit to hospital andduring their follow ups.iii) Direct cost documentation form: This form wasprepared to have all details about patients' expenses for theirdisease management during the study period.iv) Prescribed medication documentation form: This formwas prepared to have all the details about medicationprescribed by clinician to diabetes patients during the studyperiod.v) Knowledge, Attitude and Practice (KAP)questionnaire: The KAP questionnaire consisted of 30questions (knowledge-18, attitude-5 and practice-7 relatedquestions). This questionnaire were prepared first in Englishand then translated into local language by the professionalexperts. The validation of the questionnaire was done byevaluating the questions by asking them to the diabeticpatients. KAP scores were obtained through SPSS-16 andCronbach's α was determined. The Cronbach's α forknowledge, attitude and practice was 0.88, 0.64 and 0.85,respectively. The face and content validity was also done bysending the questionnaire to the experts.vii) Patient satisfaction questionnaire: The satisfactionquestionnaire consisted of 16 questions. These questionswere first prepared in English and then were translated intothe local language by professional experts. Thesequestionnaires were evaluated by the patient to know theirunderstanding about the questionnaires and scoring was doneby 5 point Likert scale.viii) Diabetes information booklet: A diabetes informationbooklet was prepared in local Nepali language. This bookletcontains primary information about diabetes, itscomplications, precautions to be taken for diabetesmanagement and medication used for diabetes treatment.Some of the information given in diabetes booklet was alsopresented in pictorial form.ix) Diabetes complication chart: This chart was prepared tomake the patients aware about long term and short termdiabetes complication which they may get any time in theirlife if they do not control their diabetes. This chart consisted ofdifferent diabetes complications in pictorial form.x) Dietary chart: This dietary chart was prepared fordiabetics. This chart was having the information about totaldietary management like what to take and what not to take bythe diabetics. The food items were presented in the pictorialform and food plates were well defined in the chart.xi) Medication calendar: Medication calendar was preparedand used in the study to make the patient well aware about themedication consumption like when to take, how to take, howmuch to take and how long to take.xii) Diabetic kit: This kit was made especially for test group-2 patient to educate them about the pattern of blood flow indiabetics and non-diabetics. Diabetic kit consisted of twoglass tubes, one tube shown normal pattern of blood flow innon-diabetics and second tube shown pattern of blood flow(effect of more sugar in blood) in diabetics. Apart from this,the kit had a provision to explain about food (fatty and nonfatty)circulation in body and fate of sugar and fat in body byusing human circulatory system chart and using the differentsynthetic balls of different smaller shapes, sizes and colour.Scoring method for KAP questions: KAP questionnairesconsist of total 18 knowledge questions, 5 attitude questionsand 7 practice questions. The patients were scored for theirknowledge, attitude and practice. In case of knowledgequestion, each correct answer was scored as one (1) and aszero (0) for incorrect answer. In case of attitude questions,they are scored on the basis of 5 point Likert scale (stronglydisagree=1, disagree=2, undecided=3, agree=4 and stronglyagree=5). The practice questions are scored on the basis of 3point Likert scale (never=0, occasional=1 and frequent=2).The maximum possible scores for knowledge, attitude andpractice question are 18, 05 and 02, respectively.Scoring method of satisfaction questions: Patientsatisfaction questionnaires consist of total 16 questions.These questions were scored on the basis of 5 point Likertscale (very dissatisfied=1, slightly dissatisfied=2, neithersatisfied nor dissatisfied=3, slightly satisfied=4 and verysatisfied=5)Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 51

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyOPERATIONAL MODALITY:Newly diagnosed diabetes patient who visited to medicinedepartment of the hospital during the study period wereenrolled in the study after getting their written consent. Total31 patients were enrolled in the study. They were divided intothree groups [control group (CG), test group-1 (TG-1) and testgroup-2 (TG-2)] on the basis of 1 to 1 enrollment method. Oneto one enrollment method is, the first patient who visited themedication counseling center was enrolled first in CGfollowed by TG-1 and TG-2. The patient demographic detailswere documented in socio-demography form. All three grouppatients were evaluated for KAP and satisfactionquestionnaire at the time of their enrollment (baseline) in thestudy.The patients enrolled in control group (CG) were kept onnormal care given by the doctor through out the study. Patientenrolled in test group-1 and test group-2 was providedpharmaceutical care. The patient enrolled in test group-1 (TG-1) were received the special counseling and education aboutdiabetes management, medication use, life style and dietarymodification and different exercises by providing themdietary chart, diabetes information booklet to make themunderstand about disease and medication calendar to increasethe patient compliance to the drugs. Patients of this groupwere also exposed to diabetes provided long termcomplication chart to aware about diabetes complication. TG-2 patient were provided all the information like TG-1 but theyalso received the extra demonstration of diabetes kit speciallymade for them. After the completion of two months from thedate of patient's enrollment, all the three groups wereevaluated for KAP and satisfaction level. The flow chart of thestudy is given in figure 1.All 31 patients enrolled in the study had undergone theirfasting blood sugar (FBS) and post prandial sugar (PPBS)check up at their first day visit (baseline) to hospital. Randomblood sugar (RBS) and glycated haemoglobin (HbA1c) wasnot taken into the consideration in the study because it was notdone uniformly in all patients. Same patients were againundergone their blood sugar check up after completion oftheir two months follow up.The total cost incurred by all three groups of patients fromtheir enrollment in the study till completion was alsocalculated. The direct cost analysis was done on the basis ofdifferent parameters like travel cost, food, hospitalregistration cost, hospitalization cost, investigation cost,medication cost. The cost calculation was done from patientperspective since the patient pay for it.Data analysis: The data collected was entered in SPSSversion16 and Microsoft excel sheet. The descriptive analysiswas done to analyze the parameter as per the objectives. Theimprovement in the KAP scores were compared usingWilcoxon signed rank test.Fig.1: The flow chart of operational modalitystPatient enrollment in study at their 1 day visit to hospital(n=31)(n=10)Control GroupBaseline(n=11)Test Group-1Baseline(n=10)Test Group-2BaselineDemography details and evaluationof KAP and satisfaction questionsDemography details and evaluationof KAP and satisfaction questionsDemography details and evaluationof KAP and satisfaction questionsNormal care with medicationduring study periodPharmaceutical care apart from normal care likei. more emphasize on education and counselingabout diabetes and importance of medication usedii.Provided diabetes booklet, diet chart, medicationcalendarPharmaceutical care likeTG-1 but also demonstrationof diabetic kit through outstudy period for two monthsAfter completion of two monthsEvaluation of KAP and satisfactionby KAP and satisfaction questionsAfter completion of two monthsEvaluation of KAP and satisfactionby KAP and satisfaction questionsAfter completion of two monthsEvaluation of KAP and satisfactionby KAP and satisfaction questionsIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 52

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyRESULTDemography details of respondent: Altogether 31 patientswere enrolled in the study. The large number of patients werein the age group of 51-60 years [11 (35.48%)]. The mean ±SDage of the patient in control group, test group-1 and test group-2 was 59.3±17.13, 51.27±13.92 and 51.70±13.91respectively. Males were 22 (70.96%). There were 20(64.51%) overweight patients. Total 28 (90.32%) patientswere non-vegetarian, 17 (54.83%) were non-alcoholic and18(58.06%) were smoker. The detail demography of thepatients is mentioned in Table 1.Table 1: Demography details of the respondentsAge intervals (yrs) Control group Test group-1 Test group-2(n=10) (n=1) (n=10)Age (yrs)0-20 0 0 121-30 1 0 031-40 1 4 141-50 0 0 151-60 1 4 661-70 4 3 171-80 3 0 0GenderMale 6 9 7Female 4 2 3Educational qualificationPrimary 6 7 5Secondary 0 1 3Tertiary 1 1 1Never 3 2 1BMI (kg/m2)

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyAlcohol intakeEveryday 1 3 0Occasional 0 1 1Former 3 3 2Never 6 4 7Smoking StatusEveryday 0 1 0Occasional 0 1 1Former 6 3 1Never 4 6 8Monthly Income (Nrs.)0-10000 6 7 410001-20000 2 1 420001-30000 1 2 130001-40000 0 1 140001-50000 1 0 0Family typeJoint 7 6 7Separate 3 5 3Family history of diseaseFather 0 1 1Mother 0 0 1Both 0 0 0BMI= Body Mass Index, NRs = Nepali rupeesDiabetic history: Two (6.45%) had their father alone while 1(3.22%) had their mother alone suffered from diabetes. Thefamily history of 28 (90.32%) patients was unknown.Therapeutic category of medication prescribed:Altogether 75 drugs were prescribed in the study population.Antidiabetics were the commonest class of drugs prescribedaccounting for 36 (48%) of the total drugs followed bycardiovascular drugs 22 (29.33%). Other medicines were17(22.66%) in number which included diuretics, vitaminsupplements, proton pump inhibitors and antimicrobials.Utilization of antidiabetics in study population: Out of 36antidiabetics prescribed, 17 (47.22%) drugs were foundcommonly prescribed from the class of biguanides followedby sulfonylureas 12 (33.33%), Insulin preparation 5(13.88%), Thiazolidinedione group of drugs 1(2.77%) andalpha glucosidase inhibitors 1(2.77%). Insulin was used in 2(12.5%) patients of CG, 1(14.28%) of TG-1 and 2(15.38%) ofTG-2 patients. Biguanides was used in 7 (43.75%) patients ofCG, 4 (57.14%) of TG-1 and 6(46.15%) of TG-2 patients.Sulfonylurea class of drugs was used in 6 (37.5%) patients ofCG followed by 2 (28.57%) of TG-1 and 4 (30.76%) of TG-2patients. Only one patient of TG-2 group and one patient ofCG were prescribed thiazolidinedione and alpha glucosidaseinhibitor class of drugs , respectively.Comparison of blood glucose pattern: All three grouppatients were evaluated for their blood sugar level at baselineand after intervention and median interquartile range wasobtained and compared for any significant effect. It was foundthat the patients of TG-2 shown the significant improvementin terms of their blood glucose level [FBS (P value= 0.008)PPBG (P value= 0.008)] as compared to TG-1 [FBS (P value=0.025) PPBG (P value= 0.050)].This significant improvementin test group-2 patients might be due to demonstration ofdiabetic kit to TG-2 subjects which made them more clearabout the fate of fatty and sugary substances once they areconsumed in the body. The median for all three groups arementioned in Table 2.Response to knowledge questions: The response of thepatients regarding the knowledge questions at baseline andafter intervention was done. The number of patientsresponding correctly to the knowledge questions ismentioned in Table 3.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 54

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyGroupsCG(n=10)TG-1(n=11)TG-2(n=10)stBaseline (1 day of visit to thehospital) Median(interquartile range)RBSFBSPPBS339 (204-438)208 (148-287)348 (322-386)GroupsCG(n=8)Intervention (2 months from the dateof enrollment)Median (interquartile range)-P value90.5 (79-103)CG pre FBS Vs CG postFBS 0.012180 (138-211) CG pre PPBS Vs CG postPPBS 0.012HbA1c - - -RBS397 (209-423)--FBS135 (122-260)98.5 (84-108)TG-1 pre FBS Vs postTG-1FBS 0.025PPBS 249 (155-379) (n=8)130 (103-140) TG-1 pre PPBS Vs postPPBS 0.050HbA1c - - -RBSTable 2: Comparison of blood glucose level of all three groups360 (210-388)FBS244 (159-360)104 (93-114)TG-2 pre FBS Vs postTG-2FBS 0.008PPBS 379 (235-416) (n=9)118 (104-188) TG-2 pre PPBS Vs postPPBS 0.008HbA1c 9.2 (8.8-10) - ----Table 3: Number of patient responding correctly to the Knowledge questionsControl group Test group-1 Test group-2Questions Baseline 2 months Baseline 2 months Baseline 2 months(n=10) (n=8) (n=11) (n=8) (n=10) (n=9)n (%) n (%) n (%) n (%) n (%) n (%)1 2 (20) 6 (75) 5 (45.455) 8 (100) 8 (80) 9 (100)2 0 0 1 (9.09) 1 (12.5) 1 (10) 2 (22.22)3 0 0 2 (18.18) 2 (25) 1 (10) 7 (77.78)4 1 (10) 3 (37.5) 4 (36.36) 8 (100) 3 (30) 8 (88.89)5 3 (30) 5 (62.5) 6 (54.55) 8 (100) 7 (70) 9 (100)6 0 2 (25) 4 (36.36) 8 (100) 6 (60) 7 (77.78)7 5 (50) 7 (87.5) 9 (81.82) 8 (100) 6 (60) 9 (100)8 2 (20) 5 (62.5) 8 (72.73) 8 (100) 8 (80) 9 (100)9 2 (20) 3 (37.5) 7 (63.64) 8 (100) 8 (80) 8 (88.89)10 0 0 1 (9.09) 2 (25) 2 (20) 1 (11.11)11 1 (10) 3 (37.5) 4 (36.36) 8 (100) 7 (70) 8 (88.89)12 2 (20) 0 2 (18.18) 4 (50) 4 (40) 7 (77.78)13 0 2 (25) 4 (36.36) 7 (87.5) 4 (40) 6 (66.67)14 4 (40) 4 (50) 6 (54.55) 8 (100) 9 (90) 8 (88.89)15 7 (70) 7 (87.5) 8 (72.73) 8 (100) 10 (100) 9 (100)16 3 (30) 2 (25) 3 (27.27) 7 (87.5) 5 (50) 8 (88.89)17 1 (10) 1 (12.5) 2 (18.18) 7 (87.5) 5 (50) 5 (55.56)18 0 2 (25) 4 (36.36) 8 (100) 6 (50) 8 (88.89)Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 55

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyResponse to attitude questions: The response of the patientsregarding the attitude related questions at baseline and afterintervention was done. The number of patient responding tothe attitude questions are mentioned in Table 4.Response to practice questions: The response of the patientsregarding the attitude related questions at baseline and afterintervention was done. The number of patient responding tothe practice questions are mentioned in Table 5.Table 4: Response of the study subject to the attitude questionsStatements Scale Baseline 2 months Baseline 2 months Baseline 2 months(n=10) (n=8) (n=11) (n=8) (n=10) (n=9)n (%) n (%) n (%) n (%) n (%) n (%)19 SD 1 (10) 0 0 1 (12.50) 1 (10) 0D 0 0 0 0 0 0UD 3 (30) 0 0 0 1 (10) 0A 4 (40) 3 (37.5) 5 (45.45) 0 0 1 (11.11)SA 2 (20) 5 (62.5) 6 (54.55) 7 (87.50) 8 (80) 8 (88.89)20 SD 4 (40) 4 (50) 4 (36.36) 5 (62.50) 2 (20) 4 (44.44)D 3 (30) 1 (12.5) 3 (27.27) 1 (12.50) 6 (60) 3 (33.33)UD 2 (20) 2 (25) 3 (27.27) 0 1 (10) 0A 1 (10) 0 0 0 0 1 (11.11)SA 0 1 (12.5) 1 (9.09) 2 (25) 1 (10) 1 (11.11)21 SD 4 (40) 4 (50) 3 (27.27) 7 (87.50) 7 (70) 6 (66.67)D 0 1 (12.5) 6 (54.55) 0 2 (20) 2 (22.22)UD 2 (20) 1 (12.5) 1 (9.09) 0 0 0A 4 (40) 2 (25) 1 (9.09) 0 1 (10) 1 (11.11)SA 0 0 0 1 (12.50) 0 022 SD 1 (10) 2 (25) 2 (18.18) 4 (50.00) 5 (50) 3 (33.33)D 3 (30) 2 (25) 4 (36.36) 0 2 (20) 0UD 2 (20) 1 (12.5) 4 (36.36) 0 1 (10) 1 (11.11)A 2 (20) 2 (25) 1 (9.09) 1 (12.50) 2 (20) 2 (22.22)SA 2 (20) 1 (12.5) 0 3 (37.50) 0 3 (33.33)23 SD 1 (10) 1 (12.5) 0 3 (37.50) 2 (20) 1 (11.11)D 0 0 1 (9.09) 0 2 (20) 2 (22.22)UD 6 (60) 5 (62.5) 5 (45.45) 3 (37.50) 3 (30) 3 (33.33)A 2 (20) 0 4 (36.36) 0 2 (20) 2 (22.22)SA 1 (10) 2 (25) 1 (9.09) 2 (25.00) 1 (10) 1 (11.11)SD = strongly disagree, D = disagree, UD = undecided, A = agree, SA= strongly agreeIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 56

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyTable 5. Response of the study subject to the practice questionsStatements Scale Baseline 2 months Baseline 2 months Baseline 2 months(n=10) (n=8) (n=11) (n=8) (n=10) (n=9)n (%) n (%) n (%) n (%) n (%) n (%)24 Never 10 (100) 8 (100) 11 (100) 6 (75.00) 9 (90) 5 (55.56)Occasional 0 0 0 2 (25.00) 1 (10) 2 (22.22)Frequent 0 0 0 0 0 2(22.22)25 Never 10 (100) 3 (37.50) 10 (90.91) 0 9 (90) 0Occasional 0 4 (50.00) 1 (9.09) 0 1 (10) 1 (11.11)Frequent 0 1 (12.50) 0 8 (100) 0 8 (88.89)26 Never 10 (100) 5 (62.50) 11(100) 0 9 (90) 0Occasional 0 1 (12.50) 0 0 0 0Frequent 0 2 (25.00) 0 8 (100) 1 (10) 9 (100)27 Never 8 (80) 1 (12.50) 10 (90.91) 0 7 (70) 1 (11.11)Occasional 2 (20) 3 (37.50) 1 (9.09) 0 2 (20) 0Frequent 0 4 (50.00) 0 8 (100) 1 (10) 8 (88.89)28 Never 6 (60) 8 (100) 11 (100) 8 (100) 10 (100) 8 (88.89)Occasional 4 (40) 0 0 0 0 1 (11.11)Frequent 0 0 0 0 0 029 Never 9 (90) 7 (87.50) 8 (72.73) 4 (50.00) 6 (60) 5 (55.56)Occasional 1 (10) 1 (12.50) 3 (27.27) 3 (37.50) 3 (30) 3 (33.33)Frequent 0 0 0 1 (12.50) 1 (10) 1 (11.11)30 Never 4 (40) 0 4 (36.36) 0 3 (30) 0Occasional 6 (60) 4 (50.00) 7 (63.64) 0 6 (60) 0Frequent 0 4 (50.00) 0 8 (100) 1 (10) 9 (100)Comparison of KAP scores: The knowledge, attitude andpractice (KAP) scores were compared among CG, TG-1 &TG-2 group patients at baseline and after intervention. Testgroup-2 patients were found to have better knowledge(scores: 131), attitude (scores: 133) and practice (scores: 81)towards diabetes as compare to TG-1 [(K scores: 118), (Ascores: 110), (P scores: 71)] and CG [(K scores: 52), (Ascores: 119), (P scores: 35)] patients after intervention.Mean ± SD scores of knowledge (K), attitude (A) andpractice (P): The mean knowledge score of the test group-2patients after the intervention was 7.112.3, this wassignificantly higher than the knowledge score at baseline(5.55±2.6) and the P value was 0.004. There was also a slightimprovement in attitude (14.77±3.2) and practice score(9±1.6) after the intervention in test group-2 patient ascompared to test group-1 patient. No significant improvementwas found in knowledge scores between TG-2 and TG-1group (6.55±2.4, P=0.001) patients after intervention. Theoverall improvement in KAP scores was found insignificantin three group patients because there was no difference in theirP value (P=0.012). The details of mean sd and p value forKAP scores are mentioned in Table 6.Direct cost analysis: Significant cost reduction was found inall three group patients during their two months study period.It might be due to reduction in frequency of theirhospitalization and prescription drugs. The medianinterquartile range for direct cost incurred by test group-2, testgroup-1 and control group patients after intervention was[618(311-836)], [312(208-403)] and CG [904(491-2046)].The details of the direct cost incurred by the diabetics arementioned in table 7.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 57

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyTable 6: Mean KAP scores of the patientsControl group Test group-1 Test group-2Baseline (n=10) (n=11) (n=10)(Pre) K A P K A P K A P(Mean ±SD) 1.83±1.9 14.5 ±2.6 1.30 ± 0.4 4.44 ± 2.4 14.54 ± 2.0 1.09 ± 1.0 5.55 ± 2.6 12.9 ± 3.0 2.10 ± 2.8Intervention (n=8) (n=8) (n=9)Post(Mean ±SD) 2.88 ±2.3 14.8 ±4.5 4.37± 2.4 6.55 ± 2.4 13.75 ± 3.9 8.87± 1.1 7.11 ± 2.3 14.77 ± 3.2 9.00 ± 1.6P-values CG pre CG pre CG pre TG-1 pre TG-1 pre TG-1 pre TG-2 pre TG-2 pre TG-2 preVs Vs Vs Vs Vs Vs Vs Vs VsCG post CG post CG post TG-1 post TG-1 post TG-1 post TG-2 post TG-2 post TG-2 post0.120 0.940 0.018 0.001 0.610 0.008 0.004 0.176 0.007Overall Mean ± SD scores of the patients for KAP(Mean ±SD) 19.1 ± 4.2 22.90 ± 3.5 25 ± 7.6(Baseline)(Mean ±SD) 24.5 ± 5.2 38.62 ± 4.9 38.33 ± 4.5InterventionP Values CG pre Vs CG post TG-1 pre Vs TG-1 post TG-2 pre Vs TG-2 post0.012 0.012 0.012K= Knowledge, A= Attitude, P= PracticeGroupsCG (n=10)TG-1 (n=11)ParametersTransportFood on way to the hospitalHospital RegistrationHospital ChargesInvestigation chargesDietary CostMedicines CostADDAntiHTN drugOthersTransportFood on way to the hospitalHospital RegistrationHospital ChargesInvestigation chargesDietary CostMedicines CostADDAntiHTNOthersCost(NRs)500930220298341953796-407799434481488100220200025721098156220343Table 7: Direct cost incurred analysisstBaseline(expenses on 1 Costday visit to hospital) (NRs)Median (interquartilerange)2132 (920-4365)363 (201-623)GroupsCG (n=8)TG-1 (n=8)283001600148425-3358167280555501000289445-89570451Expenses during twomonths study periodMedian (interquartilerange)Difference in cost(NRs) (Less) /Excess904 (491-2046) (1228.00)312 (208-403)(51.00)Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 58

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyGroupsTG-2 (n=10)ParametersTransportFood on way to the hospitalHospital RegistrationHospital ChargesInvestigation chargesDietary CostMedicines CostADDAntiHTNOthersCost(NRs)13731420014413154151522035522535stBaseline(expenses on 1day visit to hospital)Median (interquartilerange)711 (443-1362)GroupsTG-2 (n=9)Cost(NRs)119501800157560-17141540317Expenses during twomonths study periodMedian (interquartilerange)1 USD = 72.64 NRs. ADD= Antidiabetic drugs, AntiHTN= AntihypertensiveDifference in cost(NRs) (Less) /Excess618(311-836) (93.00)Comparison of satisfaction scores and Mean scores of thepatients: The satisfaction level for all three groups of patientswas evaluated at baseline and after intervention. The meansatisfaction score of the test group-2 patients after theintervention was 76.66 ± 1.9, this was significantly higher(P=0.008) than the satisfaction score at baseline (44.60 ± 3.8).There was significant improvement in satisfaction level oftest group-1 patient after the intervention (P=0.012) but notmuch significant as compare to test group-2 patients. Thedetails of the satisfaction score and mean scores of diabeticsare mentioned in table 8.DISCUSSION: Diabetes is a chronic disease conditionwhich requires lifelong treatment. Although lifestylemodifications play an important role in diabetes management.Obesity is a major risk factor responsible for causing20diabetes in worldwide population. The present study found alarge number of respondent were overweight [20(64.51%)]2whose BMI was greater than 25 kg/m . This is in concurrencewith the previous study in Malaysia where most of the2 20respondent (67%) were overweight (BMI > 25 kg/m ).Obesity is one of the leading factors to cause diabetes andcardiovascular problems in large population. The reasonbehind the obesity might be high calorie intake, sedentary lifestyle and lack of physical exercise.The present study also focused on pre and post interventionalKAP scores and effect of counseling and education on KAPscores improvement in all three groups. This study found thatthere was improvement in KAP scores of TG-1 and TG-2group patient. There was also a slight improvement in KAP ofCG patient during the study period. But there was nostatistical significant improvement in KAP of all three groups.A study from Glasgow, United Kingdom where they found theimprovement of KAP scores in control and test group subjectbut there was no significant difference in the amount of21change in KAP. Another study from Turkey on healtheducation program for type-2 diabetes mellitus patient andfound that there was significant improvement in knowledge22scores of diabetics after the educational intervention.In this study, the antidiabetic drugs were the commonest classof drugs accounted for 36 (48%) of the total drugs followed bycardiovascular drugs [22 (29.33%)]. Among the antidiabetics,biaguanides accounted for 17(47.22%) followed byGroupsCG(n=10)TG-1(n=11)TG-2(n=10)Total Satisfactionscores (Baseline)Table 8: Mean satisfaction scores of the patientsMean ± SD(Baseline)Groups439 43.90 ± 5.7 CG(n=8)Total Satisfactionscores afterinterventionMean ± SDInterventionP value429 53.62 ± 7.7 CG pre Vs CGpost 0.051496 45.09 ± 8.2 TG-1629 78.62 ± 2.1 TG-1 pre Vs TG-1(n=8)post 0.012446 44.60 ± 3.8 TG-2690 76.66 ± 1.9 TG-2 pre Vs TG-2(n=9)post 0.008Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 59

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary Studysulfonylureas 12 (33.33%) and Insulin 5(13.88%). A studyfrom South Africa, Nepal and India and they also had the23,24,19similar type of finding. The choice of antidiabeticdepends on the type of patients, their concurrent illness, costfactors, as well as the availability of medicines. In general,biaguanides is considered as a safer drug in terms ofhypoglycemia and hence to be preferred drug specially inobese patients.In the present study, there was an encouraging result found onimprovement in fasting and post prandial glucose level indiabetics. The satisfactory glycemic control was found in TG-2 patients. This improvement in glycemic control in TG-2patients might be due to an effective demonstration ofdiabetic kit apart from other educational intervention. A studyfrom Thailand about effect of counseling on glycemic controlfor six months duration and found that there was significantimprovement in glycemic control between the control and test25group subjects. A study from South India also stressed thateffective counseling and education program can improve the26glycemic level significantly in diabetics.Awareness about diabetes by counseling and educationalprogram in diabetics makes them more focus and alert to theirdisease management which brings down their economyburden significantly. In present study, it was found that directcost incurred by diabetics in all three groups during the studyperiod was more at initial stage (baseline) and reducedsignificantly after 2 months intervention. More cost initiallywas due to more prescribing of antidiabetic andcardiovascular drugs, unawareness of disease andhospitalization due to serious problem. But significantreduction in expenses in diabetics came down afterintervention in TG-2 and TG-1 patients but more reductionwas found in control group patients, it might be due toreduction in frequency of hospitalization which was foundmore initially in CG patients. A study from Denmark on costof diabetes and diabetes care also found the significant cost27incurred by diabetics in disease management.Improvement in health related problems in diabetics makesthem more satisfied to the services provided to them for theirdisease management. Present study also focused on patientsatisfaction level to pharmaceutical care program at baselineand after intervention. Significant improvement insatisfaction level was found in patients to pharmaceutical careservices provided to them. The level was more in TG-2 ascompare to TG-1 patient. A slight increase in satisfaction levelin control group patients was also seen due to informationreceived by drug prescriber about antidiabetic drugs use fortheir normal care. A study also had the similar concurrence inpatient satisfaction level due to the effect of pharmaceutical28care program.STUDY LIMITATIONS AND STRENGTHSThis study was conducted with very less number of diabetespatients within less time period. Therefore, it can not begeneralized to overall diabetic population.Moreover, thestudy enrolled the patients (total 31 patients) only from onehospital from one development region of Nepal and hence cannot be generalized to the diabetic population of Nepal. It wasalso seen from the study that few patients did not come back ordelayed their follow up in the hospital due to their financialconstraint. This was the first preliminary interventional studyconducted in Nepal in the area of diabetes awareness. Thisstudy provided the primary information about the level ofawareness about diabetes in Nepali population. This studycould be a corner stone for further study in the same area inlarge number population for longer duration.CONCLUSIONThis study identified the impact of pharmaceutical careprogram in improvement of knowledge, attitude and practiceabout diabetes in diabetics. Significant improvement wasfound in TG-1 patients and TG-2 patients in terms of theirknowledge improvement after the intervention. TG-2 patientalso shown significant improvement in their attitude andpractice as compare to TG-1 patients. The study wassuccessful in finding the prescribing pattern of antidiabeticsin a Nepalese teaching Hospital. Incidence of polypharmacyin diabetes patients was found to be high. Demonstration ofdiabetic kit combined with counseling and education programhad shown the significant effect in glycemic control of TG-2patient as compare to TG-1 patients. The present studyhighlighted the impact of pharmaceutical care program inreduction of economy burden to patients. Patient satisfactionlevel can be increased by providing proper healthcare servicesand improvement in their health related problems. Significantimprovement in satisfaction level was found in TG-2 and TG-1 patients after proper pharmaceutical care provided to them.ACKNOWLEDGMENTSThe author acknowledge to Mr.Tek Bahadur B.K whoassisted in data collection and compilation. Mr. Tek BahadurB.K is attached with Manipal Teaching Hospital where heworks as pharmacist in department of Hospital and ClinicalPharmacy, Pokhara, Nepal. We would also like to thank toDean, Manipal College of Medical Sciences who had giventhe permission to conduct the study in Manipal TeachingHospital. Authors wish to thank all the patients for theirparticipation and co-operation in the study.Conflict of interest: Authors would like to declare of noconflict of interest associated with this study.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 60

Dinesh KU - Evaluation of the Impact of a Pharmaceutical Care Program for Diabetes Patients in Nepal: A Preliminary StudyREFERNECES:1.Mehta RS, Karki P, Sharma SK. Risk factors, associated healthproblems, reasons for admission and knowledge profile ofdiabetes patients admitted in BPKIHS. Kath Univ Med J(KUMJ) 2006; 4 (1): 11-132. Triplitt CL, Reasner CA, Isley WL. Pharmacotherapy: athpathological approach. 6 ed. New York: McGraw Hill Inc,2005:1333.3. Khunti K, Ganguli S, Lowy A. Inequilities in provision ofsystematic care for patient with diabetes. Fam Pract 2001; 18:27-32.4. Mayor S. Diabetes affecting nearly 250 million adults in theworld. Br Med J 2006; 333:1191.5 Upadhyay DK, Palaian S, Shankar PR, Mishra P. Knowledge,attititude and practice about diabetes among diabetes patientsin Western Nepal. Rawal Medical Journal (RMJ) 2008; 33 (1).6. Adibah H, Idris MN Osman ali. Perception and behaviour ofdiabetic patients on blood glucose maintenance. Int J Diab DevCountries 1998; 18: 71-74.7. Cantrill JA, Wood J. Clinical Pharmacology and Therapeutic.rd3 ed. New York: Churchill Livingstone 2003: 657-677.8. UK Prospective Diabetes Study (UKPDS) Group. Intensiveblood glucose control with sulfonylureas or insulin comparedwith conventional treatment and risk of complications inpatients with type 2 diabetes. Lancet 1998; 352: 837-53.9. Anupa KC, Durga B, Subish P, Mishra P. Patientcounseling by pharmacists- a novel approach to enhancepatient compliance. J Nep Pharm Assoc 2005; 23:17-22.10. International Diabetes Federation. Diabetes Atlas. 4thEdition.Brussels, Belgium11. Tan AS, Young LS, Wan S, Wong ML. Patient education in themanagement of diabetes mellitus. Singapore Med. J. 1997;38(4): 156-60.12. Baradaran H, Knill-Jones RP, Wallia S, Rodgers A. A controlledtrial of the effectiveness of a diabetes education programme ina multi-ethnic community in Glasgow. BMC Public Health2006; 6:13413. Palaian S, Acharya LD, Rao PGM, Shankar PR, Nair NM, NairNP. Knowledge, attitude and practice outcomes: Evaluatingthe impact of counseling in hospitalized diabetic patients inIndia. P & T 2006; 31:383-400.14. Moodley L, Rambiritch V. An assessment of the level ofknowledge about diabetes mellitus among diabetic patients ina primary healthcare setting. South Africa Family Practice.2007; 49(10):16a-16d15. William KM, Zachary MN, Eva WN, Eva WM. Knowledge,attitude and practices related to diabetes among communitymembers in four provinces in Kenya: a cross-sectional study.The Pan African Medical Journal. 2010; 7:2.16. Shrestha L, Nagra JS. Knowledge, attitude and practice (KAP)study on diabetes mellitus among Nepalese diabetic patients.Nepal Med Coll J. 2005; 7(1):51-3.17. Kapur A, Shishoo S, Ahuja MMS, Sen V, Mankame K. DiabetesCare in India - Patient's Perceptions, Attitudes and Practices.Int j Diab Dev Countries.1997; 1718. Karki P, Baral N, Lamsal M et al. Prevalence of NIDDM in urbanareas of Eastern Nepal: A hospital based study. S East Asia JTrop Med Public Health 2000; 31:163-166.19. Upadhyay DK, Palaian S, Shankar PR, Mishara P, Sah AK.Prescribing pattern in diabetic outpatients in a tertiary careteaching hospital in Nepal. Journal of Clinical and DiagnosticResearch.2007; 3:248-255.20. Ambigapathy R, Ambigapathy S, Ling HM. A Knowledge,attitude and practice (KAP) study of diabetes mellitus amongpatients attending Klinik Kesihatan Seri Manjung. NCDMalaysia 2003; 2(2)21. Hamid RB, Knill-jones RP, Wallia S, Rodgers A. A controlledtrial of the effectiveness of a diabetes education program in amulti-ethnic community in Glasgow. BMC Public health 2006;6:134.22. Atak N, Arslan U. A pilot project to develop and assess a healtheducation program for type 2 diabetes mellitus patients. HealthEducation Journal 2005; 64 (4): 339-346.23. Truter L. An investigation into antidiabetic medicationprescribing in South Africa. J Clin Pharm Ther. 1998 Dec;23(6):417-22.24. Vengurlekar S, Shukla P, Patidar P, Bafna R, and Jain S.Prescribing Pattern of Antidiabetic Drugs in Indore CityHospital. Indian J Pharm Sci. 2008; 70(5): 637–640.25. Suppapitiporn S, Chindavijak B, Onsanit S. Effect of diabetesdrug counseling by pharmacist, diabetic disease booklet andspecial medication containers on glycemic control of type 2diabetes mellitus: a randomized controlled trial. J Med AssocThai. 2005; 88 (4):S134-41.26. Malathy R, Narmadha MP, Ramesh S, Alvin JM, Dinesh BN.Effect of a diabetes counseling programme on knowledge,attitude and practice among diabetic patients in Erode districtof South India. J Young Pharmacists 2011;3:65-7227. Bjork S. The cost of diabetes and diabetes care. DiabetesResearch and Clinical Practice 2001; 54 (1) S13–S18.28. Correr CJ. Effect of a Pharmaceutical Care Program on qualityof life and satisfaction with pharmacy services in patients withtype 2 diabetes mellitus. Brazilian Journal of PharmaceuticalSciences 2009; 45(4).Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 61

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaA Retrospective Study of Nosocomial infections in Patients Admitted in M.I.C.U1 1 2Pratham R* , Manmohan S , Vipin R1School of Pharmaceutical Sciences, Jaipur National University, Jaipur -302025, (Rajasthan.), India2Nariender Mohan Hospital and Heart Center, Ghaziabad, (Uttar Pradesh), IndiaA B S T R A C TSubmitted: 22/10/2011Accepted: 3/11/2011In present study, the current status of nosocomial infection, rate of infection and distribution of infection was analysed in patients admitted inMICU of a multispecialty hospital. Clinical data were collected from patients that presented with symptoms of nosocomial infection in MICU. Weexamined of 128 patients who were admitted in Nariender mohan hospital, Ghaziabad from August 2010 to May 2011. The research approachadopted in the study was a retrospective method. Incidence of nosocomial infections in MICU patients was 10.93% (14/128 patients). Urinarytract infection (42.85%) was the most frequent; followed by Lower respiratory infection (14.28%), surgical site infection (14.28%),Gastroenteritis (14.28%), Blood stream infection and Meningitis (7.14%). The nosocomial infection was seen more in the 40 to 60 year of age.The male was more prone to nosocomial infections than the female. Nosocomial infections are common in geriatric patients in the MICU setting.More studies are needed to be carried out in Indian population to plan long term strategies for prevention and management of nosocomialinfections.INTRODUCTIONInfections acquired during hospital stay are generally callednosocomial infections. Formerly, they were defined as1infections arising after 48 hours of hospital admission .National Nosocomial Infections Surveillance system definesa nosocomial infection as a localized or systemic conditionthat results from adverse reaction to the presence of aninfectious agent(s) or its toxin(s) that was not present or1incubating at the time of admission to the hospital . Asincubation period varies with the type of pathogen andpatients underlying condition, each infection must beassessed individually. As incubation period varies withsituations in which an infection is considered to be1,2nosocomial ;(I) Infection that is acquired in the hospital, but does notbecome evident until hospital discharge.(ii) Infection in a neonate that results from passage throughbirth canal.The elderly have defective host defenses that compromisetheir ability to ward off infectious agents. Factors whichinfluence immune competence are immune senescence,changes in non adaptive immunity, chronic diseases,medications, malnutrition and functional impairments. T-Address for Correspondence:Pratham R, School of Pharmaceutical Sciences, Jaipur National University,Jaipur -302025, (Rajasthan.), IndiaE-mail: prathamsrathore@gmail.comlymphocyte production and proliferation decline with age,which results in decreased cell-mediated immunity anddecreased antibody production to new antigens. Thinning ofskin, enlarged prostate, diminished cough reflex and otheranatomic or physiologic accompaniments of aging arechanges in non adaptive immunity that render the elderlymore vulnerable to infection. Chronic diseases such as cancer,malnutrition, atherosclerosis, diabetes mellitus, and dementia2predispose to certain types of infections .In addition to these, functional impairments (like immobility,incontinence, dysphasia) associated with aging necessitatethe use of urinary catheters, feeding tubes, and other invasive3devices enhancing susceptibility to nosocomial infections .There is an urgent need to focus our attention to problems ofgeriatric patients, specifically infections among MedicalIntensive Care Unit (MICU) admissions. According to4, 5, 6published literature the most prevalent nosocomialinfections among patients in the Intensive Care Unit (ICU) areurinary tract infection, pneumonia, bloodstream infections,skin and soft tissue infections, gastro-enteritis, hepatitis andcentral nervous system infections like meningitis.Billions of dollars are used annually in the developedcountries alone for the control of just these hospital acquiredinfections alone which reflect another aspect of the magnitudeof the problem. The magnitude of the problems of thenosocomial infections in other countries is even more seriousand in a developing country like India, one could one assume(since there is no established recognized statistics) theIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 62

Pratham R - A Retrospective Study of Nosocomial infections in Patients Admitted in M.I.C.Upathetic picture in terms of morbidity, mortality as well as theinvisible but very valuable economic loss. The otherfrustrating fact regarding the natural history of Nosocomial orHospital Acquired Infections is that they can not be eradicatedentirely; but many of them can be prevented by proper controlmeasures. In places where control programmes can beimplemented, there had been a proven reduction of morbidityand mortality. Furthermore, the money that can be saved byreduction of nosocomial infections is much more used forinfection control.MATERIAL AND METHODSThe study was a retrospective analytical study. Themethodology involved collection of data ofnosocomial infections from patient records, analysis ofinfections, their causes and distribution pattern of pathogens.To carry out this work, a total of 128 records of patientsadmitted to multidisciplinary MICU during December 2010to May 2011 at Nareiender mohan Hospital, Ghaziabad wereconsidered and out of these 14 belonged to medical [nonsurgical] cases. Detailed history and physical examination7notes were reviewed in all patients. A diagnostic criterion fornosocomial infection is given in table 1.7Table 1: Diagnostic criteria for nosocomial infectionsNosocomial Clinical features Laboratory featuresInfectionUrinary tractinfectionPneumoniaBlood streamInfections.Skin and softtissueInfections1. Fever2. Lower abdominalpain Change in urinecharacteristics1. Fever2. Pleuritic chest pain3. Decreased intensityof breath sounds4. Presence orincrease in ralesUnexplained fever withchills and rigor Pain,tenderness or purulentdrainage at the site ofinsertion of IV accessor CVP Catheter1. Pain, swelling,tenderness orinflammation andwarmth of skin2. Purulent drainagefrom skin3. Fever1. Leukocytosis2. Positive urine culture5(10 CFU of a singleorganism per ml ofurine)1. Leukocytosis2. Sputum for Gramstain3. Positive sputumculture4. Positive chest x-ray1. Leukocytosis2. Positive bloodculture3. Positive CVPcatheter culture(after catheterremoval)1. Smear for Gramstain2. Positive swabculture3. LeukocytosisNosocomial Clinical features Laboratory featuresInfectionGastroenteritisMeningitisRESULT1. Increased frequencyof stools2. Change inconsistency of stools3. Fever4. Dehydration1. Fever2. Altered sensorium3. Headache4. Neck stiffness5. Vomiting .1. Leukocytosis2. Positive stool culture1. Leukocytosis2. CSF- cell count, celltype, culture, sugar,proteinThe present study was conducted on 128 patients admitted inhospital MICU. Fourteen of 128 patients (10.93%) admittedto the MICU suffered from nosocomial infection, there were11 males and 3 females. The mean duration of stay of thepatients in the hospital was 14.4 days. Table 2 gives thedistribution of the nosocomial infections in these patients.Table 2: Distribution of nosocomial infectionsAmong Nosocomial Positive PatientsNosocomial infections No. of patients PercentageUrinary tract infection 6 42.85%Pneumonia 2 14.28%Soft tissue infections 2 14.28%Gastroenteritis 2 14.28%Blood stream infections 1 7.14%Meningitis 1 7.14%In our study, we observed that the distribution of nosocomialinfections in MICU patients were UTI (42.85%), LRTI(14.28%), SSI (14.28%), GI (14.28%), BSI(7.14%) andmeningitis (7.14%).The distribution of pathogens in nosocomial infection wasdescribed in table 3. According to study the commonpathogens for nosocomial infection was PseudomonasAeruginosa (urinary tract infection), E.coli (urinary tract andgastroenteritis), Staphylococcus Aureus (urinary tract andblood stream infection) and staphylococcus epidermidis(surgical site infection).Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 63

Pratham R - A Retrospective Study of Nosocomial infections in Patients Admitted in M.I.C.UOrganismsIsolatedPseudo.AeruginosaUrinary TractInfections2(33.3%)PneumoniaSkin &Softtissue infectionDiseaseGastroenteritisE.coli 2(33.3%) 2(100%)Gram -ve aerobes 1(50%)Candida albicans 1(16.6%)Table 3: Pathogens isolated in various nosocomial infectionsBlood streaminfectionsCoagulase -I'veStaph.Staph. Aureus 1(16.6%) 1(100%)Staph. Epidermidis 1(50%)MeningitisUnidentified 1(50%) 1(50%) 1(100%)Total 6 (100%) 2(100%) 2(100%) 2(100%) 1(100%) 1(100%)Table 4: Device related Nosocomial infectionsType of Nosocomial Type of Device used Infection with device Infection withoutInfection (n)deviceUrinary tract infection (06) Catheter 04 (66.6%) 02 (33.3%)Pneumonia (02) Ventilator support 01 (50%) 01 (50%)Blood stream infections (01) CVP catheter 01 (100%)Others (05) - - 05Total (14) 06 (43.85%) 08(57.14%)In our study, we have isolated the pathogens of the variousnosocomial infections of our target group and found that mostof the nosocomial infections were device related which areshown in Table 4. Urinary tract infection was related tourinary catheter; pneumonia was related to ventilator andblood stream infections were related to CVP catheter.DISCUSSIONThe incidence of nosocomial infections in our study was810.93 % compared to 33.5% by Beaujean et al & 16.02% inthe hospital record of N.M hospital and heart centre.However, our study population consisting of 14 patients outof 128 MICU admissions is a relatively small sample size.The general distribution pattern of the nosocomial infectionsthat emerged in our study showed urinary tract infection(42.85%) to be the most common, followed by pneumonia(14.28%), skin and soft tissue infections (14.28%),gastroenteritis (14.28%), bloodstream infections (7.14%),meningitis (7.14%). In a similar study done by Richards et9al , the distribution was found to be urinary tract infections(31%), pneumonia (27%), bloodstream infection (19%) and10remaining others to be 23 %. Lee et al reported their findingsas UTI (47%), pneumonia (26%) and skin infections (14%).Our study population of 14 patients included 11 male and 03female patients. Similarly with respect to the role played byinvasive devices in contributing to nosocomial infections, ourstudy showed that 66.6% of urinary tract infection, 50% ofpneumonia and 100 % of bloodstream infections could beattributed to the use of invasive devices. According to9Richards et al these are 95%, 86% and 87% respectively, afinding very similar to our study.The pathogen distribution ofnosocomial infections in our study does not differsignificantly with the findings of Richards et al. However, wefound that Pseudomonas aeruginosa to be the predominantcause of nosocomial UTI in contrast to Candida albicans9,11reported by Richards et al . This could be explained bydifferences in geographic locations, nutritional status andhealth care systems.Nosocomial infections add to functional disability, emotionalstress and may, in some cases, lead to disabling conditionsthat reduce the quality of life. In addition, nosocomialinfections have now become one of the leading causes of12death . The impact of nosocomial infections takes on evenIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 64

Pratham R - A Retrospective Study of Nosocomial infections in Patients Admitted in M.I.C.Umore significance in resource-poor countries, especiallythose affected most by HIV/AIDS, because recent findingsstrongly suggest that unsafe medical care may be an important13factor in transmitting HIV . During the past 10–20 years littleprogress has been made in addressing the basic problemsresponsible for the increasing rates of nosocomial infectionsin many countries, and in some countries, conditions areactually worsening. Nosocomial infections increase the costof healthcare in the countries least able to afford them throughincreased: length of hospitalization; treatment with expensivemedications (e.g., antiretroviral drugs for HIV/AIDS andantibiotics); and use of other services (e.g., laboratory tests,X-rays and transfusions).As a consequence, in resource poor countries, efforts toprevent nosocomial infections must assume even greaterimportance if progress is to be made in improving the qualityof patient care in hospitals and other healthcare facilities.Most of these infections can be prevented with readilyavailable, relatively inexpensive strategies by adhering torecommended infection prevention practices, especially handhygiene and wearing gloves; paying attention to wellestablishedprocesses for decontamination and cleaning ofsoiled instruments and other items, followed by eithersterilization or high-level disinfection; and improving safetyin operating rooms and other high-risk areas where the mostserious and frequent injuries and exposures to infectiousagents occur.CONCLUSIONIn study, the geriatric population is highly vulnerable tonosocomial infections. Geriatric patients have defective hostdefenses that compromise their ability to ward off infectiousagents. Our findings are similar to observations made in otherstudies in literature. Urinary tract infections and pneumoniasare the common nosocomial infections. Our study alsoreveals that the incidence of infections increases with use ofinvasive devices. Early recognition of infections restrictedand short term use of invasive devices can therefore,contributes significantly towards decreasing the incidence ofnosocomial infections in geriatric patients. We suggest thatsystematic and standardized large scale studies be carried outon elderly population for prevention and management ofnosocomial infections. Early recognition of infections,restricted and short term use of invasive devices can therefore,contribute significantly towards decreasing the incidence ofnosocomial infections in elderly.ACKNOWLEDGEMENTSWe thank the research and ethical committee of N.M hospitaland heart center (Ghaziabad) for approving our study.REFERENCES1. Garner J.S, Jarvis W.R, Emory T.G, Horan T.C, Hughes J.M.CDC definitions for nosocomial infections. American Journal ofInfection Control 1988; 16: 28-40.2. Strausbaugh L.J. Emerging Health Care associated infectionsin the geriatric population. Emerging Infectious Diseases2001; 7(2): 268-271.3. Taylor M.E, Oppenheim B.A. Hospital acquired infection inelderly patients. Journal of Hospital Infection 1998; 38: 245-260.4. Crossley K.B, Peterson P.K. Infection in elderly, principles andthpractice of infectious diseases. 5 edition Philadelphia, 2000;3164-3169.5. Emori T.G, Bannerjee S.N, Culver D.H. Nosocomial infectionsin elderly patients in United States. American Journal ofMedicine 1991; 91 (3): 289-293.6. Richards M.J, Edwards J.R, Culver D.H. Nosocomialinfections in combined medical surgical intensive care units inU S. Infection Control Hospital Epidemiology 2000; 21: 510-515.7. Mukherjee T, Pramod K, Srinivasan G, Rao M.Y. Nosocomialinfections in geriatric patients admitted in ICU. Journal of TheIndian Academy of Geriatric 2005, 2: 61-64.8. Beaujean D.J, Blok H.E, Grauls C.M. Surveillance ofnosocomial infection in geriatric patients. Journal of HospitalInfection 1997; 36: 275-284.9. Richards MJ, Edwards JR, Culver DH, Gaynes RP.Nosocomial infections in medical intensive care units in UnitedStates. National nosocomial infection surveillance system.Critical Care Medicine 1999; 27: 887-892.10. Lee Y.L, Thrupp L.D, Friis R.H, Fine M, Maleki P, Cesario T.C.Nosocomial Infection and antibiotic utilization in geriatricpatients-a pilot prospective surveillance program in nursingfacilities. Gerontology 1992; 38: 223-232.11. Lee Y.L, Thrupp L.D, Friis R.H, Fine M, Maleki P, Cesario T.C.Nosocomial Infection and antibiotic utilization in geriatricpatients-a pilot prospective surveillance program in nursingfacilities. Gerontology 1992; 38: 223-232.12. Ponce-de-Leon S. The needs of developing countries and theresources required. J Hosp Infect 1991; 18: 376–381.13. Gisselquist D. HIV infections in sub-Saharan Africa notexplained by sexual or vertical transmission. Int J STD AIDS2002; 13(10): 657–666.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 65

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaImpact of Clinical Pharmacists Counseling on Quality of Life in patients withCongestive Cardiac Failure.1 1 2 1 1 1Anoop P* , Radhika N , Selvamuthu K.S , Saravanakumar R.T , Madhusudhan S , Mohanta G.P .1Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamilnadu.608002.2Associate Professor of Medicine, RMMC&H, Annamalai Nagar,Tamilnadu.608002A B S T R A C TSubmitted: 14/10/2011Accepted: 21/11/2011Quality of life is defined as “an individual perception of their position in life in the context of the culture and value systems in which they live and inrelation to their goals, expectations, standards and concerns.” Quality of life is a measure of a person's physical and psychological contentment.The study was conducted in order to study the impact of clinical pharmacist's counseling on Qol in patients with heart failure using Kansas CityCardiomyopathy Questionnaire (K.C.C.Q). The study was conducted on 70 patients and the influence of various intra and inter patientelements like age, gender, ejection fraction, duration of the disease on the questionnaire were studied. Compliance was assessed by pill countmethod. Subsequently the patients were counseled and followed for a period of time. A significant difference in QoL score and compliance wasachieved compared to that of the baseline. By the end of the study more patients were found to be compliant. In conclusion, Patient counselingaided the patients in better understanding of the disease and its control which ultimately improved their health related Quality of life.Keywords: Congestive cardiac failure, pharmacist impact, QoL, K.C.C.QINTRODUCTIONThe concept of quality of life is not yet defined in a uniformway, lacks clarity and even creates confusion. It seems that inmedicine, the term has become a bandwagon concept for allthose human needs which are often neglected in a health carefield increasingly dominated by technology. It is justifiable tosay that it is a term describing a field of interest rather than a[1]single variable . HRQL measures the illness experience asopposed to the disease; it defines the patient reality, his or herpoint of view as opposed to the reality defined by professional[2]medical knowledge . According to WHO, QoL is defined as“an individual perception of their position in life in thecontext of the culture and value systems in which they live andin relation to their goals, expectations, standards and[3]concerns” . QoL assessment could be a useful tool formonitoring the progress of patients receiving drug therapy.Improvement in QoL may be the main goal of treatment inpatients with some diseases like Rheumatoid Arthritis, CCFetc. In these diseases, the therapeutic goal is to avoidimpairment in QoL caused by the adverse effects of the drugs[4]and distress which results in Non-Compliance .Congestive Cardiac Failure (CCF) is a condition progressingto early death and affecting Quality of Life in the form ofAddress for Correspondence:Anoop P, Apt# A4, Jawahar Apts, OP Main Road, Chidambaram - 608002Tamilnadu.E-mail: anoopparchuri@yahoo.co.in[5, 6, 7, 8]fatigue, breathlessness and oedema . Congestive heartfailure is a global burden disease, commonly more prevalentin developed and developing countries and the prevalenceranging from 0.3% to 2% in the population at large, 3-5% inthe population are 65 years old, between 8% and 16% of thoseaged over 75 years. The prevalence of CCF in India was 18.8million per year (1.76%) of the total population and the[9]incidence was 1.57 million per year (0.15%).[10, 11]Measuring of the Quality of LifeOne goal of the measurement of quality of life is to haveobjective evaluations of how and how much the diseaseinfluences patient's life and how patients cope with it. Theseevaluations may be useful as a baseline outcome measuresand should provide framework to determine the impact of any[12, 13, 14, 15]change on patient's quality of life .Some examples of specific instruments to measure quality oflife in heart failure patients are: 1. The Chronic Heart FailureQuestionnaire; 2. The Minnesota Living with Heart FailureQuestionnaire; 3. The Yale Scale; 4. The Quality of LifeQuestionnaire in Severe Heart Failure and 5. The Kansas CityCardiomyopathy Questionnaire.[16, 17, 18]Limitations of Quality of LifeQuality-of-life instruments have always been seen as long,time consuming and unresponsive assessment tools; but,since the introduction and availability of shorter, easiermethods to understand and administer tools, there has been anIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 66

Anoop P -Impact of Clinical Pharmacists Counseling on Quality of Life in patients with Congestive Cardiac Failure.18]increase in their use in clinical trials [ . Their validity may besuspected if they do not measure components of quality of lifethat are important to the patient. Many instruments are notderived from patient populations but from an expert medicalviewpoint. Quality-of-life measures usually comprise anumber of items to which patients respond. To maximise therelevance of these items, they should be derived, whereverpossible, from a patient population. Many scales, e.g., thegeneric and disease-specific measures already described,were not derived from a patient's perspective. Instead, theyrely on the perspective of professionals, and it may be the casethat medical professionals may have a different view of theaspects of function that are important to quality of life.Role of Pharmacists and PatientThe pharmacist's role is to verify whether the patients havesufficient understanding, knowledge and skill to follow theirpharmaco-therapeutic regimens and monitoring plans.Pharmacists should also seek ways to motivate patients tolearn about their treatment and to be active partners in theircare. Patient's role is to adhere to their dosage regimens,monitor for drug effects, and report their experiences topharmacists or other members of their health care teams.Optimally, the patient role should include seekinginformation and presenting concern that may make adherencedifficult. Depending on the health system's policies andprocedures, the use of protocols or clinical care plans, and itscredential in providers, Pharmacists may also have diseasemanagement roles and responsibilities for specifiedcategories of patients. This expands pharmacists and thecontent of education and counselling sessions.Kansas City Cardiomyopathy Questionnaire (K.C.C.Q)[19]The Kansas City Cardiomyopathy Questionnaire is theleading health-related quality-of-life measure for patientswith congestive heart failure.The Kansas City Cardiomyopathy Questionnaire is a 23-item,self-administered instrument that quantifies physicalfunction, symptoms (frequency, severity and recent change),social function, self-efficacy and knowledge, and quality oflife. In the KCCQ, an overall summary score can be derivedfrom the physical function, symptom (frequency andseverity), and social function and quality of life domains. Foreach domain, the validity, reproducibility, responsiveness andinterpretability have been independently established. Scoresare transformed to a range of 0-100, in which higher scoresreflect better health status. For brevity, only the performancecharacteristics of the overall summary score are presented inthis discussion. KCCQ has advantage over the otherquestionnaires in not only capturing the physical limitations,but also independently quantifies symptoms (frequency,severity and stability), social limitations, patients' sense ofself-efficacy and QoL and is also most sensitive to any clinicalchange.[20-23]Patient counsellingCounselling is both an art and science, science because of itsunderlying principles and art because of the blend of thecounsellor's personality, technique and skills. Counselling isabout helping people and as people and treatment aredifferent, likewise there can be no universal or predeterminedmethods of counselling. It helps the patient to take themedication in a manner that is most likely to achieve thedesired therapeutic response.Appropriate advising and counselling by the pharmacist willmake the patient understand better about their medicationswhich have become potent and toxic with the advancement ofscience. This will in turn increase patient compliance, whichcan otherwise result in inappropriate or inadequate use ofdrugs.The objective of the counselling is to provide directions,instructions, advices about the drug as per prescription andimply a positive behaviour in which the patient is motivated toadhere to the prescribed treatment. Moreover, as per the newcode of ethics it become the responsibility of the pharmacistto counsel the patient before dispensing of drugs in manycountries.[24]Patient compliancePatient compliance or adherence may be defined as the extentto which a patient takes or uses medication in accordance withthe medical or health advice given. Patients on short termmedication tend to show greater compliance than thosepatients with long term therapy.The objective of the study is toŸ To educate the patient about the disease and the drug.Ÿ To assess the medication compliance by self-assessmentmethod.Ÿ To assess and improve the quality of life in patients withCongestive Cardiac Failure using Kansas CityCardiomyopathy Questionnaire.METHODOLOGYThis prospective observational study was conducted at RajahMuthaiah Medical College and hospital, Annamalai nagar.Tamilnadu. The study was carried out during November2010-April 2011. The patient enrolment in the study wasbased on the inclusion criteria followed by their signedconsent.Quality of LifeThe QoL is measured by using Kansas City CardiomyopathyIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 67

Anoop P -Impact of Clinical Pharmacists Counseling on Quality of Life in patients with Congestive Cardiac Failure.Questionnaire (K.C.C.Q). In the KCCQ, an overall summaryscore can be derived from the physical function, symptom(frequency and severity), and social function and quality oflife domains. For each domain, the validity, reproducibility,responsiveness and interpretability have been independentlyestablished. Scores are transformed to a range of 0-100, inwhich higher scores reflect better health status. Thequestionnaire focuses on the following clinically relevantdomaines:Physical limitations (question 1), symptoms frequency[questions 3, 5, 7 and 9], severity [questions 4, 6 and 8] andchange over time [question 2], self-efficacy and knowledge(questions 11, 12), social interference (question 16) and QoL(questions 13–15).[24]Compliance assessment (pill count)Compliance assessment contains a formula to calculatecompliance by pill count method.Total no of tablets taken ×100Compliance = -----------------------------------------------------Total no of tablets to be takenPill count method – When compliance score was analysedindividually considering different range of scores, a clearpicture of compliance pattern has emerged.Self-assessment form contains a grading scale of compliance.With this form patients will grade their compliance accordingto their perceptions: 1. Almost followed prescribed regimen,2. Sometimes follow prescribed regimen, 3. Compliant half ofthe time, 4. Compliant most of the time, 5. Compliant all thetime. It also contains factors which effect patient compliancelike Forget fullness, Confusion, Apathy, Health beliefs,Dissatisfaction, Cost of medication and others.Patient counsellingPatients in the study group were counselled. The session last5-10 min. counselling was given bilingually (both in Tamil &English). Information was tailored according to theunderstandings of the patients. Follow up of patient wascarried out during their successive monthly appointments.The patients were followed at a period of 30 d, 60 d, and 90 dintervals.In this study 78 patients were enrolled and complete data wereavailable for 70 patients, the remaining 8 could not befollowed within the study period.RESULTSA total of 78 patients were enrolled in the study. Among these78 patients, complete data was available for only 70 patientsfor analysis for QoL, and compliance. Remaining 8 patientscould not be followed up due to various reasons. Statisticalanalysis was done by using Paired Students “T” test inMicrosoft Excel 2010.Baseline Characters of Patients in the StudyOut of 70 patients included in the study 42 (60%) patientswere males and 28 (40%) patients were females. (Table No.1)Out of 70 patients included in the study 8(11.42%) patientshad an age ≤ 45, 15 (21.42%) patients were in the age 46-55,Table 1: Baseline Characteristics of the Patient.FACTORS NO OF PATIENTS (70)GENDERMale 42(60%)Female 28(40%)AGE≤45 8(11.42%)46-55 15(21.42%)56-65 19(27.14%)≥66 28(40%)EJECTION FRACTION≤20 0(0%)21-30 2(2.85%)31-40 17(24.28%)≥41 51(72.85%)NYHACGRADE I 28(40%)GRADE II 28(40%)GRADE III 14(20%)NUMBER OF DRUGS PRESCRIBED≤2 2(2.85%)3 20(28.57%)≥4 48(68.57%)DURATION OF THE DISEASE0.5-3 YEARS 36(51.42%)4-6 YEARS 26(37.14%)≥7 YEARS 8(11.42%)and19 (27.14%) patients were in the age 56-65 and 28(40%)patients were >66. (Table No.1)Out of 70 patients included in the study, the patients withejection fraction ≤ 20 were 0, 21-30 were 2 (2.85%), 31-40were 17 (24.28%) and ≥41 were 51 (72.85%). (Table No.1)Out of 70 patients included in the study 28 (40%) patientsbelonged to NYHA classification I, 28 (40%) patientsbelonged to NYHA classification II and 14 (20%) patientsbelonged to NYHA classification III. (Table No.1)Out of 70 patients included in the study 2 (2.85%) patientsIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 68

Anoop P -Impact of Clinical Pharmacists Counseling on Quality of Life in patients with Congestive Cardiac Failure.were taking ≤ 2 drugs. 20(28.57%) patients were taking 3drugs and 48(68.57%) patients were taking≥4 drugs (TableNo.1)Out of 70 patients included in the study, the patients withduration of disease 0.5-3 years were 36(51.42%), 4-6 yearswere 26(37.14%), and ≥ 7 years were 8(11.42%). (TableNo.1)Other than congestive cardiac failure, 10(14.2%) patients hadCOPD, 35(50%) had Hypertension, 15(21.4%) had diabetesmellitus, 5(7.14%) had hyperlipidemia, and 5(7.14%)patients had other co-morbidities. (Fig. 1).Impact of counseling on Quality Of Life (Table No.2)Mean scores for QoL at end of the study of was 80.12 ± 10.93as compared to 43.628 ± 10.36 that of the baseline.Impact of counseling on Age (Table No.3)For age group ≤ 45 years the baseline QoL was 51.12 ± 10.55and the final score was 82.37 ± 11.14.For age group 46-55 years the baseline QoL was 42.6 ± 10.53and the final score was 81.73 ± 10.97.For age group 56-65 years the baseline QoL was 42.58 ±10.20 and the final score was 81.05 ± 11.15.For age group ≥ 66 years the baseline QoL was 41.85 ± 10.36and the final score was 78 ± 10.88.Impact of counseling on Gender (Fig.2)Fig.1For males' baseline QoL was 42.7 ± 10.9 and the final scorewas 80.45 ± 10.88.For females' baseline QoL is 43.9 ± 10.5 and the final scorewas 79.64 ± 10.70.Medication complianceFig.2Table 3: Impact of counseling on ageAge BASELINE FOLLOW FOLLOW FOLLOWUp1 Up2 UP 3≤45 51.12±10.55 63.12± 10.83 72±11.26 82.37±11.1446-55 42.6±10.53 61.26±10.56 71.93±6.08 81.73±10.9756-65 42.58±10.20 58.05±10.49 69.94±11.10 81.05±11.15≥66 41.85±10.36 56.64±10.40 67.67±10.86 78±10.88Out of the 70 patients included in the study, 46 (65.7%) werecompliant with prescribed regimen all the time and 24(34.2%) were compliant most of the time (Fig. 3).No one scored below 60% or below as the compliance score,10(14.28%) patients scored in the range of 61-90% and26(37.14%) scored≥ 90% (Table No.4).Fig.3Table 2: Impact of counseling on mean scores of QoLNo of BASELINE FOLLOW FOLLOW FOLLOWPATIENTS Up1 Up2 UP 370 43.628±10.36 58.757±10.48 69.7±10.94 80.12±10.93The values are expressed as Mean ± SD. n=70Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 69

Anoop P -Impact of Clinical Pharmacists Counseling on Quality of Life in patients with Congestive Cardiac Failure.The reasons cited for non-compliance by the patients are:5(9.8%) forgetfulness, 5 (9.8%) confusion, 1 (1.9%) apathy,2(3.9%) could not afford the cost of the medication and 3(5.8%) others as their reasons for non-adherence (Fig.4).Table 4: Compliance score distributionSCORE FOLLOW UP 1 FOLLOW UP 3(2-weeks)(6- weeks)≤60 --------- --------61-90 4(5.71%) 10(14.28%)≥90 9(12.8%) 26(37.14%)DISCUSSIONFig.4Patient counseling is an integral part of Clinical Pharmacyactivities, since it provides an opportunity for Pharmacist tointeract with patient and establish a continuing relationshipwith patients.An attempt has been made to carry out the work to the best ofthe ability of the department and persons involved. The resultswere classified under following broad categories:1. Baseline characteristics.2. Quality of life.3. Medication Compliance.Baseline characteristicsOut of the 70 patients enrolled in the study, males exceededfemales in number. The number of patients in the age group of56-65 and 46-55 were almost equal. The number of patients inage group ≥66 dominated the study because this age group ismost affected by the disease condition which are focused inthis study and actively utilizing the health care system.The numbers of patients taking more than 4 drugs weredominant over the number of patients taking ≤ 2 and 3groups. Most of the patients were on 4 drug therapy. Patientswith duration of disease of 3 years and less dominated othergroups of 4-6years and 6 years or above. Newly diagnosedpatients tend to remain with the healthcare system and as thetime progresses dropout increases due to increaseddependency on others, this resulted in more number ofpatients in 3year group.Patients with Ejection fraction of ≥41 dominated others.The number of patients in NYHA class 1 and class 2 are equaland are more in number compared to class3 and class 4.Quality of lifeQuality of life can be influenced by various factors such asgender, age, number of drugs consumed, and duration ofdisease. While studying the effect of Quality of life each of thementioned factors was taken into consideration and itsinfluence was analyzed separately.In a study conducted by Gabriel. E soto et al 2004 and Green.[19]et al 2000 , QOL was measured by the Kansas CityCardiomyopathy Questionnaire (KCCQ). The KCCQ scorewas compared between baseline and final follow-up. TheKCCQ had a significant reduction with basal condition fromthe first evaluation. Similarly in our study the mean score inthe first, second and third follow up were significantcompared to baseline (P

Anoop P -Impact of Clinical Pharmacists Counseling on Quality of Life in patients with Congestive Cardiac Failure.patients rated themselves as always complaint. Thecompliance score calculated by Pill-count method showedthat none of the patients scores were

Anoop P -Impact of Clinical Pharmacists Counseling on Quality of Life in patients with Congestive Cardiac Failure.19. C. Patrick Green, MD, Charles B. Porter, MD, FACC.Development and Evaluation of the Kansas CityCardiomyopathy Questionnaire: A New Health Status Measurefor Heart Failure. JAAC 2000; 35.20. Ramesh. A, Parthasarathi.G, Karin, Hansen N. A text book ofclinical pharmacy practice.New York: Orient longman; 2004: 43-53.21. Johnstone.JM, Vienet. MD. Practice standards and definitions.Melbourne: The society of hospital pharmacist of Australia;1996.th22 Remington The science and practice of pharmacy. 19 edition(vol-2). Pennsylvania: Mack publishing company; 2002.23. Lewis.R. k, Lasack.NL, Lambart.BL, Connar.SE. Patientcounseling: A focus on maintenance therapy.54. Americanjournal of health system pharmacists; 1997: 2084-2098.24..Vitalina Rhozenfeld, Jean Marie Pflomm, Kulvinder. K. Singh,Michellak. K et al. Assessing the impact of consultation with amedication event monitoring system. Hospital pharmacy 1999;34:539-549.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 72

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaRespiratory Tract Problems associated with allergies in Punjab region, India-A survey report1 2 2 2 2 2Singh B * , Mallik S , Kumar N , Ali M ,Mehra R.K , Kumar P1Lovely Professional University, Phagwara, Punjab-1444022Translam Institute of Pharmaceutical Education and Research, Meerut, UP-250001A B S T R A C TSubmitted: 2/11/2011Accepted: 21/11/2011Present study was carried out to investigate the factors which are responsible for respiratory tract problems oftenly associated with symptomaticallergy. The survey was based on the questionnaire method; it was carried on 126 respondents in LPU (Punjab). Results showed that majority ofpatients were males (58%), female (42%), and were in the age group between 21-30 years (48%). Allergens (smoke/dust 38%, humidity 13%,perfume 16%, powder 15%, food article 2%, poullants 10%, temperature 6%) which led to respiratory tract problem were found more in urbanarea (63%), as compared to rural area (37%). 58% individuals took self medication and 42% got the treatment from registered medicalpractitioner. The present study states that presence of allergens and location are the major factors which are responsible for respiratory tractproblems.Keywords: Respiratory tract problems, allergens, smoking, self medicationINTRODUCTIONRespiratory illnesses caused by respiratory infections arecontagious diseases. As early as in 1927, a highly significantcorrelation between overcrowded houses and pneumoniamortality in England and Wales was observed. There is astrong correlation between person per room and number ofchildren per family and mortality from broncho pneumonia inchildren. Pneumonia epidemics have also been observed incrowded living conditions in South African mining camps,1and during the construction of the Panama Canal.In both children and adults, upper respiratory illness is mainlycaused by viral agents especially the rhinoviruses, coronaviruses, influenza and par influenza virus, adenovirus andrespiratory syncytial virus. Viral infection often leads tobacterial infection such as pneumonia in the developingcountries. On the other hand, respiratory syncytial virus, parinfluenza viruses type I, II and III, influenza virus type A andB, adenoviruses and enteroviruses mainly cause lower2respiratory illness in children.Malnutrition is generally regarded as a risk factor forrespiratory infection. However, malnutrition is closelycorrelated with crowding, poverty, poor education and poor3housing in developing countries.Asthma is a chronic respiratory disease characterized by theAddress for Correspondence:B. Singh, Lovely Professional University, Phagwara, Punjab-144402E-mail: santanu.mallik@gmail.cominflammation of the airways and variable airflow4obstruction. Self-medication and improper prescriptionstatus is a major era in developing countries in the health,because most of the people are economically deprived. Selfmedicationis where an individual treat their ailments andconditions with medicines which are approved and available5without prescription. It causes many complications. Apartfrom this another major problem is improper prescriptionstatus. These changes lead to failure of therapy and resistance.Respiratory infection is also one of the major problems in the6world.Some studies have observed a relationship between acutelower respiratory tract infection in the first two years of lifeand chronic respiratory disease in later life. For example,acute lower respiratory infection in childhood has been7related to chronic cough in young adults , adult mortality is8due to bronchitis, reduced lung function and increased9bronchial reactivity.Early cross sectional studies reported relations between10anxiety and upper respiratory illness , and between lifechanges, maladaptive coping, social isolation, unresolved11role crises with respiratory infections.Previously studied survey reports prove that most of thepersons used self-medication mainly for the treatment ofrespiratory tract infection illness such as common cold,.12cough, and feverOne study shows that low socioeconomic status is a risk factorfor a broad array of adverse COPD health outcomes.Clinicians and disease management programs shouldIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 73

Singh B -Respiratory Tract Problems associated with allergies in Punjab region, India-A survey reportconsider SES as a key patient-level marker of risk for poor13outcomes.In India, there have been only a few population-based studies14,15 16on the prevalence of COPD some hospital based studies17and some in specific population groups such as workers or18patients attendants. Only few of these studies have usedstandardized questionnaires, operational definitions ofchronic bronchitis and asthma. Few studies with regard to therisk factors associated with chronic respiratory disease inurban areas have been conducted. Questionnaires are the mostcommonly used subjective instrument of measurement inrespiratory epidemiology. They represent a convenient tool ofinvestigating large sample population owing to low cost, easyto use by the investigator, and good compliance of the19subjects.MATERIAL AND METHODSThe survey report is based on the questionnaire method,where patients suffering from respiratory problems wereincluded in the study. It was carried out after obtainingapproval from Dean, LFAMS, Lovely ProfessionalUniversity, Phagwara, in the state of Punjab, India.ObjectivesŸ Assessment of respiratory health by questionnaire surveyŸ Assessment of behavioural characteristicsStudy SampleThe number of individuals in the age group 10-40 year was200, the total number of individuals who were actuallyscreened were 126. The rest of 74 individuals could not bescreened because of their non- availability.Study PeriodthPeriod of study was four month from 15 February, 2009 toth14 June, 2009. The population under study was also verifiedduring this period. All the collected data were analysedtabulated and subjected to statistical analysis.Planning and procedure followed for the studyIndividuals were randomly selected within the universitycampus. We developed a questionnaire asking whether theywere suffering from RTP or not, symptoms associated withRTP, smoking history, exercise and details of medicationhistory were noted.RESULTS AND DISCUSSIONIncidence of Respiratory tract problem according togenderTable 1 shows, Incidence of the Respiratory disease accordingto gender where 73 (58%) were male as compared to 53 (42%)were female. Most studies from India and other countrieshave observed a male preponderance for the occurrence ofCOPD. The difference is attributed to the differential rates ofsmoking and occupational exposure between the two20genders. The ratio of incidences has been representedgraphically in Graph 1.Table 1: Incidence of RTP according to genderMale (%) Female (%)58 42Fig. 1: Incidence of Respiratory problem according to genderDistribution of Respiratory tract problem according toageTable II shows the distribution of the Respiratory individualaccording to the age. In the present study respiratory problemis more in the age group 21-30 year is 48%. Some studies haveobserved a relationship between acute lower respiratory tractinfection in the first two years of life and chronic respiratorydisease in later life. For example, acute lower respiratoryinfection in childhood has been related to chronic cough in21 22young adults , adult mortality from bronchitis , reduced lungfunction and increased bronchial reactivity. The ratio ofincidences has been represented graphically in Graph 2.Table 2: Distribution of Respiratory problem according to ageGroup Age (in year) Distribution of candidateswith RTP (%)G1 10-20 20G2 21-30 48G3 31-40 32Fig. 2: Distribution of Respiratory tract problem according to ageIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 74

Singh B -Respiratory Tract Problems associated with allergies in Punjab region, India-A survey reportIncidences of causative allergen of RTP in male andfemaleTable III show the various type of allergen which areresponsible for the respiratory tract problem. Smoke/dustconstitute 38%, humidity 17%, perfume 20%, powder 19%,food article 2%, poullants 12% and temperature 8% of allthese allergen is responsible for the respiratory tract problemin the present study. Allergic diseases result from a complexinteraction between genes, allergens and co-factors whichvary between regions. The role of allergens in thedevelopment of asthma is well established. The ratio ofincidences has been represented graphically in Graph 3.Table 3: Incidence of causative allergen of RTP in male and femaleAllergens Subject (%)Smoke/dust 38Humidity 13Perfume 16Powders 15food article 02Poullants 10Temperature 06Fig. 3: Incidences of causative allergen of RTP in male and femaleTable 4: Incidence of medication trend in both male andfemale suffering from RTPSelf medication (%) Registered Medical Practitioner (%)58 42Fig. 4: Incidence of medication trend in both male andfemale suffering from RTPIncidence of RTP in both male and female according tolocationTable V show the distribution of respiratory tract problem ismore in urban 79% and 47% in rural area. Air pollution isconsidered as the most important contributing factor forrespiratory illnesses in urban area. The ratio of incidences hasbeen represented graphically in Graph 5.Table 5: Incidence of RTP in both male and femaleaccording to locationUrban (%) Rural (%)63 37Fig. 5: Incidence of Respiratory problem according to genderIncidence of medication trend in both male and femalesuffering from RTPTable IV shows that self medication is more commonly usedin the respiratory tract problem 58% as compared toregistered medical practitioner 42%. It was reported invarious survey, most of the individuals used self-medicationmainly for the treatment of respiratory tract infection illnesssuch as common cold, cough and fever. The ratio ofincidences has been represented graphically in Graph 4.CONCLUSIONThis study shows a very clear picture that respiratory tractallergies are more common today, where environmentalpollution has a great role to play. Teenagers are often thesuffers from such problems due to smoking habits mainly,followed by perfume and humidity. No doubt people areIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 75

Singh B -Respiratory Tract Problems associated with allergies in Punjab region, India-A survey reportgetting more health conscious day by day but still a majorportion of people believe in self medication. 'The moremodern, the more pollution'- the proverb is true as two third ofthe study subject belongs to urban area.REFERENCES1. Finland M. Pneumococcal infections. In: Evans AS, FeldmanHA, eds. Bacterial infections in humans. Epidemiology andcontrol. New York, Plenum1982; 142:68-85.2. Graham MH. Psychological factors in the epidemiology ofacute respiratory infection. MD thesis. Adelaide, SouthAustralia, University of Adelaide 1987; 12:130-9.3. James JW. Longitudinal study of the morbidity of diarrheal andrespiratory infections in malnourished children. Am J Clin Nutr1972; 25: 690-69.4. Holgate ST. Genetic and environmental interaction in allergyand asthma. J Allergy Clin Immunol 1999; 104: 1139-1146.5. Durgawale PM. Practice of self medication among slumdwellers. Ind J pub Health 1998; 42: 53-55.6. Macfarlane JT, Colville A, Guion A. Macfarlane, R.M., Rose,D.H., Prospective study on aetiology and outcome of adultlower respiratory tract infection in the community. Lancet 1993;341: 511- 514.7. Colley JRT, Reid DD. Urban and social origins of childhoodbronchitis in England and Wales. BMJ 1970; 2: 213-217.8. Barker DJP, Osmond C. Childhood respiratory infection andadult chronic bronchitis in England and Wales. BMJ 1986;293:1271-1275.9. Mok JYQ, Simpson, H. Outcome for acute bronchitis,bronchiolitis and pneumonia in infancy. Arch Dis Child 1984;59: 306-309.10. Belfer ML, Shader RI, Di Mascio A, Harmatz, JS, Nahum JP.Stress and bronchitis. BMJ 1968; 3: 805-806.11. Jacobs MA, Spilken AZ, Norman MM, Anderson LS. Life stressand respiratory illness. Psychosom Med 1970; 32: 233-242.12. Phalke VD, Phalke DB, Durgawale PM. Self medicationpractices in rural maharashtra. Ind J Com Med 2006; 31:21-26.13. Eisner MD, Blanc PD, Omachi TA, Yelin EH, Sidney S, Katz PP,Ackerson L M G, Tolstykh I, C Iribarren. Socio-economic status,race and COPD health outcomes. J Epidemiol 2011; 65:26-34.14.15.16.17.18.Radha TG, Gupta CK, Singh A, Mathur N. Chronic bronchitisinan urban locality of New Delhi-an epidemiological survey. Ind JMed Res 1977; 66:273-85.Akhtar MA, Latif PA. Prevalence of chronic bronchitis in urbanpopulation of Kashmir. J Indian Med Assoc 1999; 97:365-9.Wig KL, Guleria JS, Bhasin RC, Holmes E Jr, Vasudeva YL,Singh H. Certain clinical and epidemiological patterns ofchronic obstructive lung disease as seen in Northern India. IndJ Chest Dis 1964; 6:183-94.Rastogi SK, Gupta BN, Mathur N, Husain T, Mahendra PN,Pangtey BS. A survey of chronic bronchitis among brasswareworkers. Ann Occup Hyg 1992; 36:283-93.Malik SK. Chronic bronchitis in North India. Chestm1977;72:800.19. Liard R, Neukirch F. Questionnaires: a major instrument forrespiratory epidemiology. Eur Respir Mon 2000; 15: 154-166.20. Chhabra P, Sharma G, Kannan AT. Prevalence of RespiratoryDisease and Associated Factors in an Urban Area of Delhi. IndJ Com Med 2008; 33(4):87-96.21. Colley JRT, Douglas JWB, Reid DD. Respiratory disease inyoung adults: influence of early childhood lower respiratorytract illness, social class, air pollution and smoking. BMJ 1973;3: 195-198.22. Barker DJP, Osmond C. Childhood respiratory infection andadult chronic bronchitis in England and Wales. BMJ 1986; 293:1271-1275.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 76

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaStudy of Prescribing Pattern for Evaluation of Rational Drug Therapy in WarangalPavani V, Mihir. Y. P*, Shravani K, Prabhakar R VSt. Peters Institute of Pharamceutical Sciences, Vidyanagar, Hanamkonda, Warangal, Andhra Pradesh-506001, IndiaA B S T R A C TSubmitted: 3/11/2011Accepted: 15/11/2011The present study of prescribing pattern for evaluation of rational drug therapy was carried out in Warangal city for a period of six months. Twohundred and fifty prescriptions written by qualified medical graduate and postgraduate doctors were collected and studied for theirappropriateness and rationality. The doctor's identity, patient's name, age and address, superscription, route of administration and duration oftherapy were mentioned in 100%, 100%, 15%, 0%, 35%, 24% and 100% of prescriptions respectively. Drug use has been found to beinappropriate in 20% of the drugs and large numbers of prescriptions do not confirm to the ideal pattern.Keywords: Prescription format, Prescribing patterns, Rational drug therapyINTRODUCTIONRational drug prescribing can be defined as appropriate drugstaken in the right dose, at correct time intervals and for1sufficient duration. Inappropriate prescribing leads toineffective, unsafe treatment, exacerbation or prolongation ofillness, distress and harm to the patient and higher costs of2treatment. Irrational prescription of drugs is of common3occurrence in clinical practice, important reasons being lackof knowledge about drugs, unethical drug promotions andirrational prescribing habits of clinicians. Monitoring ofprescriptions and drug utilization studies can identify theproblems and provide feedback to prescribers so as to create4awareness about irrational use of drugs. Variations in types ofdrugs used and in the way they are used is considerable evenwhen comparing small adjacent areas and in comparing5physician working within same area. The present study wasundertaken to identify inappropriate drug use in Warangal andsuggest remedial measures to make drug therapy morerational.MATERIALS AND METHODSThe methodology used in the present study was retrospective,and the study was carried out for a period of six months (FromFebruary 2011 to July 2011). About two hundred and fiftyprescriptions written by qualified medical graduate andpostgraduate doctors were collected. Patients visiting outpatientdepartments of MGM Hospital in Warangal city orpharmacies around MGM Hospital, Warangal, AndhraPradesh were approached and requested to have theirAddress for Correspondence:Mihir Y.P, St. Peters Institute of Pharamceutical Sciences, Vidyanagar,Hanamkonda, Warangal, Andhra Pradesh-506001, IndiaE-mail: mihirparmar4uonly@yahoo.comprescriptions xeroxed. Those patients, who agreed to therequest, were also interviewed to have information about.Ÿ Patients demographic data - age, sex, address anddiagnosis.Ÿ Chief complaints for which medical advice was sought.Ÿ Brief medical history.Ÿ Drug history i.e. dose, dosage, amount of drug used or useof other corrective measuresŸ Any other remarks.The collected prescriptions were evaluated for(I) Adherence to prescription format.(II) Rationality of prescription.(I) Adherence of prescription formatFor studying adherence to prescription format followingfeatures of prescription were analyzed:-(a) Identification of patient: whether name, age, sex andaddress of the patient were mentioned or not.(b) Superscription denoted by 'Rx'. Prescriptions wereanalyzed for presence or absence of 'Rx' and also whethersome other mode of writing superscription was used or not.© Inscription: It included analyses of number, name, doseand dosage of drugs used.(d) Subscription: Whether directions regarding dosage andtotal amount of drug to be dispensed were given to thepharmacist or not.(e) Transcription or signa: Whether instructions regardinguse of drugs were given to the patient or not.(f) Prescriber's identity: Whether name, registrationnumber and address of the prescriber were mentioned or not.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 77

Mihir Y.P - Study of Prescribing Pattern for Evaluation of Rational Drug Therapy in Warangal(g) Date of issuing the prescription, whether mentioned ornot.(II) Rationality of prescription(a) Number of drugs prescribed.(b) Number prescribed in generics.c) Number of fixed dose combinations used.(d) Dose strength and dosage of drug whether written or not.(e)(f)Duration of therapy – short, long, or not mentioned.Banned drug formulations.All the drugs used were assigned different categories using[6]criteria suggested by Kunin et.al .RESULTSPatient's Identity: Name, age, address were mentioned in100 %, 15 % and 0 % of the prescriptions respectively. Date ofwriting prescription was mentioned in 100% of prescriptions.Superscription: Traditionally denoted by letter 'Rx' wasmentioned in 35 % of prescriptions. 65% of prescriptionswere without superscription.Inscription & Subscription: It consists of four componentsi.e. base, adjuvant, corrective and vehicle. Since only alreadycompounded drugs were studied, these components ofinscription were not analyzed separately. Route of drugadministration was mentioned in 24 % of drugs only, rest ofthe drugs were in oral dosage forms (76%). However, dosageforms were mentioned in 74.8 % of the drugs. In 57.7 % ofprescriptions, duration of therapy was mentioned.Instructions to the patient: Instructions to the patient wereinadequate in 32 % of the prescriptions. Instructions weregiven in simple English in 20% and using local language in 80% of the prescriptions. Instructions regarding refilling ofprescription and substitution of products were not given in allthe cases.Prescriber's Identity: Name and qualification of theprescriber were known in 100 % of the prescriptions.Registration number was also known in 100 % of theprescriptions.For rationality of prescription: Average number of drugsper prescription was 3.41. Drugs were not prescribed undergeneric name in any of the cases. Fixed drug combinationswere used in 7.9 % of prescriptions.Dose strength & dosage: Dose and dosage were notmentioned in 25.2 % of the prescriptions. Dose and dosagewere found incorrect in 8% of the prescriptions in which theyare mentioned.Duration of therapy: Duration of therapy was not mentionedin 42.3 % of prescriptions. In majority of the cases,instructions' regarding duration of drug therapy was verbal. Inthose cases where the duration had been mentioned, it wasfound to be correct in 52 %, short in 38 % and prolonged in 10% of prescriptions.Overprescribing: Over prescribing was encountered in 25 %of the prescriptions e.g. paracetamol was prescribed inaddition to various anticold preparations which alreadycontain paracetamol, more than one NSAIDS was prescribedto same patients.Banned drug formulations: None of the drugs banned bydrug controller of India were used in the present study.On analysis of various drugs based on the criteria suggested[6]by Kunin et al, 1973 , it has been found that use of drug wasinappropriate in 20% of the cases.Table 1: Analysis of PrescriptionsParticularNumberTotal number of prescriptions 250Total number of drugs used 854Average number of drugs per prescription 3.41Drugs prescribed under generic names 0.0 (0%)Drugs prescribed under brand names 854 (100%)Fixed dose combinations used 68 (7.9%)Dose and dosage not mentioned 216 (25.2%)Duration of therapy not mentioned 362 (42.3%)DISCUSSIONTwo parameters were assessed in the present study i.e.adherence to prescription format and rationality ofprescription. Results obtained after auditing prescriptions forprescription format indicate that majority of prescriptions donot adhere to the ideal pattern of prescription writing.Important demographic parameters like age and gender werenot written in majority of the cases. Directions regarding totalamount of drug to be dispensed and instructions regarding useof drug were inadequate in 45 % & 28 % of the prescriptionsrespectively.Second component of the present study was auditingprescriptions for rationality. Though quality of prescribing isassociated with use of relatively limited number of7pharmaceutical products. It is preferable to keep the numberof drugs prescribing as low as possible since higher figuresalways lead to increased risk of drug interactions and8,9increased treatment cost. Average number of drugs perprescription (3.41) in the present study was less than that10,11,12reported by various Indians and international workers.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 78

Mihir Y.P - Study of Prescribing Pattern for Evaluation of Rational Drug Therapy in WarangalPrescribing under generic name is considered economical andrational but none of the prescriptions were written under ageneric name. Though this figure is higher than reported bysome Indian researcher yet it is too little to be considered11rational.Over prescribing was found only in 25% of the prescriptions,a figure far less than that reported by other Indian11researchers. It was also found that drug use was found to beinappropriate in one-third of the cases. Antibiotics were themost inappropriately used drugs. This not only exposespatients to avoidable adverse drug reactions but also totheproblems of drug resistance.From the results of the present study, we conclude thatAuthorities should arrange periodic refresher courses inrational drug therapy and in latest management of diseases forthe doctors.More emphasis needs to be laid on teaching the art of writinga prescription to undergraduate and postgraduate medicalstudents. A week's posting in clinical pharmacology andtherapeutics if possible, should be taught over duringinternship and this period should be utilized in teachingprescription writing and rational drug therapy.This study has a limitation that the total number ofprescriptions were only two hundred and fifty and morestudies are needed to be carried out in order to confirm thesefindings.REFERENCES1. Country Assistance Plan – Nepal. Asia Development Bank, Mar30 1999.2. M de Vries, TPG, Heluling RH, Hogerzeil HV, Freste DA. Guideto Good prescribing. A practical guide W.H.O. 1994.35:575-6.4. Pradhan SC, Shewade DG, Shashindren CH, Bapna .IS. Drugutilization studies. National Med Jour India 1988; 1:185-89.5. Molstad S, Hovelius B, Kroon L, Melender. A prescription ofantibiotics to outpatients in hospital clinics, Community healthcentre & private practice. Eur Jour clin Pharmacol 1990; 39:9-12.6. Kunin CM, Tupasi T, Craig WA. Use of antibiotics: a briefexposition of problem and some tentative solutions. Ann InterMed 1973; 79:555-560.7. Bergman U, Popa C. Tomson Y. Drug utilization 90 % a simplemethod for assessing the quality of drug prescribing. Eur JourClin Pharmacol 1998; 54:113-18.8. Nies SA. Principles of therapeutics. Gilman GA, Rall WT. NiesSA, Taylor P, (Eds). The pharmacological basis of therapeutics8th Eels New York Pergamon Press 1990; 62-83.9. Atanasova I, Terzivaov D. Investigations on antibiotics in ahospital for a one year period. Int Jour clin Pharm Ther 1995;33:32-33.10. Minocha KB, Bajal S, Gupta K. A clinic pharmacological studyof out-patient prescribing patterns of dermatological drugs in anIndian tertiary hospital. Ind Jour Pharmacol 2000; 32:384-85.11. Ansari KU, Singh S, Pandey RC. Evaluation of prescribingpatterns of doctors for rational drug therapy. Ind Jour ClinPharmacol 1998; 30:43-46.12. Rehana HS, Nagarani MA, Rehana Moushullli . A study on thedrug prescribing pattern and use of antimicrobial agents at atertiary care teaching hospital in eastern Nepal. Ind JourPharmacol 1998; 30:175-80.3. Ramsay L E. Blidging the gap between clinical pharmacologyand rational drug prescribing. Br J Clin Pharmacol 1993;Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 79

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaEvaluation of the Impact of a Training Module on Patient Counseling for Practising CommunityPharmacistsRamanath K.V*, Nagavi B.GDepartment of pharmacy practice, S.A.C. College of pharmacy, B.G. Nagar, Mandya(Dist.)A B S T R A C TSubmitted: 12/11/2011Accepted: 15/11/2011Patient counseling is considered as an important responsibility of the community pharmacists. An effective counseling will improve themedication adherence and help in achieving the therapeutic goal. Due to various barriers, most of the community pharmacists in India are notproviding patient counseling. The study aimed at assessing the impact of training on patient counseling to the selected community pharmacists.Two six hours training modules were conducted twice for this purpose. Through postal letters and personal interviews, 14 & 22 qualifiedregistered and practicing pharmacists respectively were selected in the first and second training programs. A pretest was conducted to assessthe entry-level knowledge of the pharmacists, followed by six hours teaching and role-plays on patient counseling. At the end a post test wasconducted to assess the exit level knowledge. A pseudo patient method was adopted to assess the counseling process of the trainedpharmacists at their pharmacy by the research pharmacist. United States pharmacopoeia counseling guidelines were used to assess thecounseling process. The result of the study showed an improvement in the post test scores and utilization of more counseling items duringcounseling sessions. The feedback results of the community pharmacists showed that the six hours training module was good and they neededmore such training in future to gain confidence in practicing patient counseling.Keywords: Patient counseling, Community pharmacistsINTRODUCTIONThe pharmacist is the first point of contact in the community1.setup on matters related to drugs and drug usagesCommunity pharmacists are a vital link between thephysician and patients. His role as a counselor to thecommunity satisfies the medical needs of the society, which2can draw the acceptance and respect from the society .According to the WHO report, the roles and responsibilities ofthe community pharmacists includes – 1. Verify the legality,safety and appropriateness of the prescription order, checkingthe medication record before dispensing and dispensingaccurately with appropriate patient counseling. 2 Monitor ofdrug utilization, potential drug allergies and drug interaction.3. Provide the drug related information to the prescribers andpatients for proper utilization .4. Actively involve in healthpromotion like rational usage of drugs, alcohol abuseprevention, family planning program and AIDS preventionprogram.5. Health care screening services like monitoring ofblood pressure, cholesterol, blood sugar, pregnancy testing. 6.Consulting services to both patients and staff, like patientprofile monitoring, staff education and in services.Address for Correspondence:K.V. Ramanath, S.A.C. College of Pharmacy, B.G.Nagar, Mandya ( Dist)Email- kattavenkateshramanath@gmail.com,kattavenkatesh_ramanath@rediffmail.comThe community pharmacist in US and UK are well acceptedand trusted by the public. As patient counseling is mandatory,the pharmacist is involved in providing the health carescreening services, and home medication review (HMR)activities.In India the community pharmacist's role is not well defined.They were restricted to dispensing rather than counsel.Reasons for failure to extend the pharmaceutical servicesare.1.Most of the pharmacist basic minimum qualification isDiploma in Pharmacy 2. Lack of awareness about theprofessional roles and responsibilities 3 .Lack of training,knowledge, confidence, incentives, and availability ofpharmacist 4. Lack of coordination between the physician and4, 5, 6-12patient .The present study was carried out to eliminate these barriersand to impart patient counseling knowledge in their serviceswith the following objectives1. To train selected community pharmacists on patientcounseling.2. To impart knowledge, skills and patient counselingmethods to the practicing community pharmacists.3. To evaluate the impact of training module in practicingcommunity pharmacists.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 80

Ramanath K.V -Evaluation of the Impact of a Training Module on Patient Counseling for Practising Community PharmacistsMETHODOLOGYStudy criteria:Inclusion criteria: Registered Pharmacist holding Diplomain Pharmacy (D.Pharm/B.Pharm) and working in or owningcommunity pharmacy .Exclusion criteria; Unqualified / unregistered persons /technicians working in pharmacies.The training module was prepared after conducting personalinterview with four community pharmacists who have goodpatient load at a busy Community pharmacy. About twentytop moving drugs and ten diseases which were highlyprevalent were considered to prepare the module. Pharmacistknowledge, attitude towards patient counseling was alsoevaluated for designing the workshop. Based on the feedbackinformation from the community pharmacists, the patientinformation leaflets (PIL) were prepared for the selecteddrugs and diseases. A six hours training module was designedfor the Community Pharmacists- which included lectures anddiscussions on patho physiological basis of disease,management of disease, drugs used , communication skills,role-play on patient counseling, and training on health carescreening instruments.The selected pharmacists were briefed about the importanceof patient counseling in their professional practice prior to thetraining registration application. The requisition letters wereprovided to the pharmacists who showed interest, haveconsented to participate in the Programme.A total of two training programmes were conducted, one inthe month of February and another in the month of May. Thevarious materials like patient information leaf lets, counselingaids (dummy inhalers and asthma devices) and health carescreening instruments (Sphygmomanometer, Peak flowmeter and Capillary Blood Glucometer).Twenty two pharmacists registered for the training, but only14 pharmacists attended the first training Programme. Apretest was conducted before the training program, and theirperformance was assessed after the training.In the first training Programme disease like Asthma, Diabetesmellitus, and Hypertension were discussed and drugs likeAtenolol, Amlodipine, Salbutamol, Glibenclamide,Metformin hydrochloride, Paracetamol, and Iron preparationwere discussed. In the afternoon session patient counseling,various items of patient counseling, barriers, and methods toover come the barriers use of pictograms in the practice werediscussed. Proper use of inhaler technique was demonstrated.The last session was dedicated for role-play. The mastercounselor showed the model and encouraged the participantsfor role-play, their strength and weaknesses were evaluatedand feedback was given. After the first test, an assessmentform was prepared based on the USP guidelines for patientcounseling. A total of 20 valid points, which were morepractical, were incorporated in the assessment form . Eachitem was evaluated for 10 marks.The evaluation of the community pharmacists was done bypersonal visit to their pharmacy, by the observer, andevaluated the counseling technique performed by thepharmacist to the patient. A second workshop/training wasorganized after three months. Out of 80 selected pharmacistsincluding the previous participants. 29 were registered, butonly 22 attended the program.For the second training programme diseases chosen for thediscussion were peptic ulcer, malaria and tuberculosis. Thedrugs were Omeprazole Ranitidine, antimalarials drugs likeChloroquine and Quinine, Antitubercular drugs likeRifampicin, Isoniazid, Ethambutol, Pyrazinamide andPyridoxine. In the afternoon session barrier of patientcounseling and strategies to overcome these barriers werediscussed.In this module health care screening services like B.Pmeasurement, peak flow meter reading and blood glucosemonitoring were also demonstrated. After training program aposttest was conducted and results were tabulated.Once again the patient counseling was assessed by personalvisit to the pharmacy, by the observer and evaluated thecounseling technique performed by the communitypharmacist.After the assessment, a questionnaire on the impact of atraining module on patient counseling of the program wasdistributed among the community pharmacists andopinion/feedback was taken from them.RESULTSA total of 77 and 80, Community pharmacists wereapproached and explained about the importance of patientcounseling in their practice in the first and second trainingstndprogramme respectively. 22(1 ), and 29(2 ) pharmacistsshowed interest to participate in the training programme, butstndonly 14 (1 ), 22 (2 ) pharmacy owners and practicingpharmacists attended the first and second training program.The demographic details of the first and second trainingcommunity pharmacist's are shown in the table1.The barriers for the pharmacists, not attending the trainingProgramme were assessed based on the response given bythem later when approached, The details are given in thetable2.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 81

Ramanath K.V -Evaluation of the Impact of a Training Module on Patient Counseling for Practising Community PharmacistsTable1: Demographic details of community pharmacistsof first and second training modulestndParameter I training II trainingmodulemodule1.SexMale 9(64.28%) 16(72.27%)Female 5(35.71%) 6(27.77%)2. Age in years20-30 4(25.57%) 9(40.90%)31-40 6(42.85%) 10(42.85%)41-50 3(21.42%) 3(45.45%)51-60 1(7.1%) -3.QualificationsD.Pharm 8(57.14%) 18(81.81%)D.Pharm with other qualifications 9(42.85%) 4(18.18%)like BSc,B.Com etc4. Years of experience1-5 Years 5(35.71%) 9(40.90%)6-10 Years 5(35.71%) 7(31.81%)11-15 Years – 3(13.63%)16-20 Years 4(28.57%) 2(9.09%)Table2: Comparison of the barriers for not attending thetraining programstndReasons I training II trainingmodulemodule1.Lack of locum 33(52.3%) 28(48%)2.Lack of interest 23(36.5%) 16(21.5%)3.Lack of locum( non availability 19(30.1%) 6(10.5%)of pharmacist)4.Lack of idea about its use 12(19.4%) 6(10.5%)5.Lack of direct monetary benefits 12(19.4%) 7(12.06%)6. Lack of transportation and the 4(6.3%) 2(3.42%)venue of Programme is too farA pretest was conducted to assess the professional knowledgeof the Community Pharmacists. The pretest questionnaireincluded basic concepts of drugs and cosmetic act, basicknowledge of pharmacology. After the training Programmethe post test was conducted and assessed their knowledge.The pretest and post test scores of the community pharmacistare given in the table3.For assessing the patient counseling items used by thecommunity pharmacists the USP patient counselingquestionnaire was used. The patient counselingquestionnaire consisted of counseling introduction items (1-4), counseling content items (5-13), counseling process items(14-16), and counseling conclusion items (17-20). The patientcounseling items used by the community pharmacists afterTable-3: Percentages of the pretest and post testscores of the community pharmacistsPercentage Pretest scoring Post test scoring75 -- 7(31.81% distinction)the first and second training programs are given in the table4.After the assessment of patient counseling items, the personalopinion about the training programme was assessed/evaluated by using questionnaire for the trained communitypharmacists. 81.8% of pharmacists expressed that thetraining program was very useful and informative & 6 hourstraining module was good and interesting. 18.2% ofpharmacist said that training should be for 4 hours. 54.5% ofthe participants expressed a feeling of 2 diseases weresufficient to be covered in one and half hour schedule and36.3% of participants mentioned that 3 diseases are adequatein the session. Only 9% of the participants mentioned thatsession must be restricted to one disease, where as 81.8% ofthe participants were satisfied with the information giving oncounseling points for drugs, 95.4% agreed that patientcounseling is must, to improve their professional state andrecognition in the society, and 81.8% of the participantsexpressed that pharmacist should do health care services suchas B.P monitoring, blood glucose estimation and lungfunction test.86.36% of participants have readily agreed thatattending continuing education programme certainlyenhanced their confidence in the practice and helps toanalyzing and removing barriers for patient counseling.About 77.27% of participants mentioned that demonstrationon health care screening will help them to put that in theirpractice. All participants agreed that communication skills areessential for working pharmacist and also mentioned that theyare very much interested in attending the future continuingeducation Programmes.DISCUSSIONOne of the main responsibilities of the community pharmacistis to provide information on drugs and disease, diet and lifestyle modification to the patient. Unfortunately the scenarioin India is different. The community pharmacist has becomemore traders and dispensers rather than a health careprofessional. This may be because lack of proper training oncounseling to the community pharmacist, lack of monitorybenefits for counseling,. Hence this study was mainly aimedat to bring considerable change in pharmacists attitude, skillsand knowledge.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 82

Ramanath K.V -Evaluation of the Impact of a Training Module on Patient Counseling for Practising Community PharmacistsstndTable4: Use of individual patient counseling items by the community pharmacists after the I and II training programsItems Number of pharmacist Number of pharmaciststin I trainingndII training1.Conducts appropriate counseling introduction 14(100%) 21(100%)2.Obtains patient initial drug related problems 2(14.28%) 20(95.2%)3. Warns patient about taking other medication 0(0) 9(42.85% )4. Assesses the patient understanding the therapy 10(71.42%) 21(100% )5. discusses the need and indication of the medication 13(92.85%) 21(100%)6. Explains the dosage regimen 12(85.71%) 21(100%)7. Explains how long to take 5(35.71%) 18(85.71%)8.Discusses storage recommendations 0(0) 13(61.90%)9.Discusses the potential side effects 2(14.28%) 7(33.33 %)10. Discusses the how to manage the side effects of drug if they do occur 2(14.28%) 7(33.33% )11.Discusses precautions 4(28.57%) 15(71.42% )12. Discusses the significant interactions 1(7.14%) 3(14.28%)13.Explains what to do if the patient misses the dose 0(0) 3(14.28%)14. Uses the language patient is likely to understand 14(100) 21(100% )15.Uses appropriate counseling aids 5(35.71%) 6(28.57% )16.Uses open ended questions 11(78.57%) 2 (100% )17.Verifies the patient understandings 5(35.71%) 16(76.19%)18.Summarize by emphasizing key point of the information 1(7.14%) 9(42.85%)19.Provides an opportunity for final concerns or questions 3(21.42%) 8(38.09%)20.Helps patient to plan follow-up and next step 2(14.28%) 16(76.19% )When community pharmacists were approached during thefirst training module, they have given many reasonsexpressing their inability to attend the training programme.Common reasons for not attending the training were lack oftime, lack of interest, and lack of locum,. Pharmacist's showedlack of awareness about the professional responsibilities andattitude for learning in the second training program. and manypharmacist have attended from near by village & number ofparticipants was increased by 50%. The reason for thisenhancement was identified as increased awareness andcoordination by the fellow pharmacist who attended thetraining program.The result of the pretest suggested that many pharmacistknowledge base is poor. because, most of the pharmacist havecompleted their professional qualification that is diploma inpharmacy, five years ago (70%). During their practicepharmacists were restricted only to dispensing and did nothave an opportunity to enhance their knowledge in theirregular practice. Only the continuing education program mayhelp them to nurture their knowledge and professional skills.The post test results suggested that though the communitypharmacist were away from the college for long time, they arein the profession, there by they performed better counseling.During the first counseling skills assessment, it was observedthat no community pharmacist warned the patient abouttaking the drugs of other systems like Ayurveda/Homeopathy.No pharmacist gave any storage recommendations and theinformation in case the patient misses a dose. Very fewpharmacists discussed about the potential side effects andstrategies to over come them.ndDuring the 2 training assessment the performance of theCommunity Pharmacists was considerably enhanced. Thismay be because of giving the feedback to the pharmacistsregarding their strengths and weakness and helping them totune their skills.The validation results proved that the designed trainingmodule was appropriate and kindled interest for counseling,helped them to analyze and reduced their barrier forcounseling. All the pharmacists agreed that the programenhanced their communication skills. They also suggestedthat these programs should be conducted at least once in twomonths. This suggests that if proper training is given to all thepharmacists will be motivated to offer the patient counseling.CONCLUSIONSelected community pharmacists of Mysore city were trainedin two modules on diseases like Diabetes, hypertension,asthma, peptic ulcer disease, malaria, tuberculosis andIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 83

Ramanath K.V -Evaluation of the Impact of a Training Module on Patient Counseling for Practising Community Pharmacistsvarious drugs used in the treatment. Patient InformationLeaflets were prepared based on the drugs and diseases. Thepre and post training evaluation indicated that training onpatient counseling had a positive impact on the communitypharmacists of Mysore city.The present training module considerably enhanced theperformance of patient counseling by community pharmacistand improved their counseling skills .The study showed thatthe need for such programs to enlighten the communitypharmacists on the role, they can play and contribute tohealth care in the community. All the participants realized thatpatient counseling is their professional responsibility.Limitation of the study:1. This study is limited only to the selected communitypharmacists of Mysore city; Similar study can beextended to the hospital pharmacy and other places ofcommunity pharmacies also.2. The number of community pharmacists who participatedin the training is very less compared to the numberpracticing. Hence the generalization cannot be made onthe out come achieved. More studies are to be conductedto achieve statistically significance conclusions.ACKNOWLEDGMENTSWe acknowledge our sincere thanks to Principal, JSS Collegeof pharmacy for constant support to finish this research workin smooth manner. We also thank to HOD of department ofpharmacy practice, all the community pharmacists and otherparticipants who involved directly or indirectly in this work.REFERENCES1. Role of pharmacist in health care system “WHO, Geneva,1990.16-19.2. Revi kumar. “ Department of hospital and clinical pharmacys e r v i c e s ” . P h a r m a c y p r a c t i c e m e d i c a l c o l l e g e ,thiruvanathapuram year 1999,page no 11-19.3. USP medication counselling behaviour guidelines”. USPDIupdate volumes I and II Rockville, the united statepharmacopoeia convention,Inc 1997: 664-675,1739-1748.4. S.Mg Ginnity et al. “ Counselling patient on discharege”hospital pharmacist ,September 1999: 6:224-226.5. Richard K,Lewies etal . “ Patient counselling –How to make ithappen in your pharmacy”. Australian pharmacist : august1991: 10: 163-167.6. Susans J.Sanders and Kim Brackly. “ New roles in primary care:skills training to promote to effectiveness” Pharm J: August1996:257:297-2987. Cartina R. Livingstone et al . “ Developing communityPharmacy services wanted by local people information andadvice about Prescription medicines ” Int J Pharm Pract: June1996:91-1018. Rose Marie Parr. “ A study of pharmacists attitude andparticipation in continuing education in Scotland ” Pharm J:1997:259:32-34.9. Rose Marie Parr et al “ Shared Learning – A collaborativeEducation and Training intiative for community pharmacistand general medical practitioners” Pharm J: January 2000:264:35-38.10. Alison Blenkinsopp. “Community Pharmacy services andstandards: Royal Pharmaceutical Survey”. Pharm J: March1997:258:633-635.11. Down Sykes and Pauline Westwood. “Training CommunityPharmacists to advise general Practiceners on Prescribing”.Pharm J: March 1997:258:417-418.12. Michael Wilcock. “Asthma Training and the CommunityPharmacists”. Pharm J: February 1998:260:315-316.Indian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 84

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Instructions to AuthorsElectronic journal articleMorse SS. Factors in the emergence of infectious diseases. EmergInfec Dis [serial online] 1995Jan-Mar [cited 1996 Jun 5];1(1):[24screens]. Available from: URL: http://www.cdc.gov/ncidod/EID/eid.htmWorld Wide WebFormat: Author/editor (surname initials). Title [online]. Year [citedyear month day]. Available from: URL:World Wide Web page McCook A. Pre-diabetic Condition Linked toMemory Loss [online]. 2003 [cited 2003 Feb 7]. Available from: URL:h t t p : / / w w w . n l m . n i h . g o v /medlineplus/news/fullstory_11531.htmlAbbreviations for Journals For More information on medlineindexed journals : Download list of medline journals:ftp://ftp.ncbi.nih.gov/pubmed/J_Medline.zipAmerican Journal of Pharmacy- (Amer J Pharm)Analytical Chemistry- (Anal Chem)British Journal of Pharmacology and Chemotherapy- (Brit JPharmacol)Canadian Journal of Pharmaceutical Sciences- (Can J Pharm Sci)Clinical Pharmacokinetics- (Clin Pharmacokinet)Drug Development and Industrial Pharmacy- (Drug Develop IndPharm)Helvitica Chimica Acta- (Helv Chim Acta)Indian Journal of Medical Sciences- (Indian J Med Sci)Indian Journal of Pharmaceutical Sciences- (Indian J Pharm Sci)Journal of the American Chemical Society, The- (J Amer ChemSoc)Journal of Biological Chemistry- (J Biol Chem)Journal of Organic Chemistry, The- (J Org Chem)Journal of Pharmacology and Experimental Therapeutics- (JPharmacol Exp Ther)New England Journal of Medicine- (N Engl J Med)Pharmaceutical Journal, The (Pharm J)PharmacologicalResearch Communications- (Pharmacol ResCommun)AUTHOR's CHECKLIST FOR SENDING PROOFS TOEDITORIAL OFFICEIn order to maintain quality and consistency in Indian Journal ofPharmacy Practice, we ask you to perform the following items priorto submitting your final proof for publication:· Include the original, hard copy of Author's Transfer ofCopyright signed by each author· Thoroughly check the article for typographic errors, formaterrors, grammatical errors, in particular: spelling of names,affiliations, any symbols, equations in the context, etc.· Provide graphs and figures in excel format, Pictures arerequired as high resolution images (300 dpi).· Provide laser printed hard copies of all figures and graphics inblack and white or scanned copies can also be sent toijopp@rediffmail.com· Submit a proof corrected with RED INK ONLY.· List out the corrections made in typed format in a separate pagewith the proof.Send the Corrected Proof, Copyright Transfer Form, with covering letter in a single envelope to the Following AddressAuthors are required to send their contributions or manuscripts through post or courier services.Dr. Shobha Rani R HiremathEditor, Indian Journal of Pharmacy Practice (ijopp).C/o. Association of Pharmaceutical Teachers of India (APTI),H.Q: Al-Ameen College of Pharmacy,Opp. Lalbagh Main gate, Hosur Road, Bangalore 560 027, Karnataka, INDIA.All enquiries can be made through e-mail: ijopp@rediffmail.comIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011