APTI ijopp - Indian Journal of Pharmacy Practice

Indian Journal of Pharmacy PracticeijoppVol.1(2), Jan-Mar, 2009EDITOR-IN-CHIEFADr. Shobha Rani R. Hiremathshobha24@yahoo.comPASSOCIATE EDITORSDr. G. ParthasarathiDr. Pramil Tiwaripartha18@airtelmail.inptiwari@niper.ac.inTASSISTANT EDITORSMr. Jaiprakash S. VastradMr. Ramjan Shaikjsvastrad@gmail.comramjanshaik@gmail.comIEDITORIAL 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 9878488050 | +91 9972588878+91 9916069842 | Ph: +91 80 32712981; Fax: +91 80 22225834www.ijopp.org || ijopp@rediffmail.com

Indian Journal ofPharmacy PracticeIndian Journal of Pharmacy PracticeijoppVol.1(2), Jan-Mar, 2009CONTENTSEditorialReview ArticlesClinical Pharmacy Practice in PsychiatryChristopher P Alderman -----------------------------------------------------------------------------------------------1-7Genesis, Development and Popularization of Doctor of Pharmacy (PharmD) Education Program at theGlobal level -A study based on the story from 1955 to 2009.Sonal Sekhar M, Suja Abraham, Revikumar KG--------------------------------------------------------------------8-17Good Pharmacy Practices in Chronic Disease ManagementNeelam Mahajan-----------------------------------------------------------------------------------------------------18-20Drug Information Centre (DIC)-An Indian ScenarioNitesh S Chauhan, Firdous, R Raveendra, Geetha J, B Gopalakrishna,Roopa Karki-------------------------21-27Research ArticlesA prospective study comparing Total Lymphocyte Count (TLC) and CD4 counts in HIV patients in aresource limited setting in IndiaLincy Lal, Cijo George, Anitha Yesoda, Jayakumar.B-------------------------------------------------------------28-35A Study of Clinical Pharmacist Initiated Changes in Drug Therapy in a Teaching HospitalBhupathy Alagiriswami,Madhan Ramesh, Gurumurthy Parthasarathi, Hatthur Basavanagowdappa----36 -45Pharmacy and Therapeutics Committee in Bangalore Institute of Oncology - Promoting RationalPharmaceutical ManagementDivya Hariharaputhran, Sunitha C. Srinivas, Ramesh S. Billimaga, Ajai Kumar B.S------------------------46-52

Indian Journal of Pharmacy PracticeijoppVol.1(2), Jan-Mar, 2009Efficacy and Safety of Azithromycin with Various Cephalosporins Used in Treatment of LowerRespiratory Tract Infection1 2Imran Ahmad Khan , Shobha Rani. R.H .-------------------------------------------------------------------------53 - 61Evaluation of Drug Information Service provided by Clinical Pharmacy Department based onProvider and Enquirers' Perspective1 2 3 4 5Kuchake V.G , Maheshwari O.D , Surana S.J , Patil P.H , Dighore P.N .--------------------------------------62-68Short CommunicationsPreliminary Clinical Study of a Polyherbal Formulation (Wh1) in the Treatment of VaginitisVishnu Bapat, Leena Alfred, Shobha Rani R.Hiremath, Pushpa. T Ksheerasagar,Geetha Hegde, Soumya. K. Lund.----------------------------------------------------------------------------------69-74Prevalence of Diseases and Observation of Drug Utilization Pattern in Geriatric Patients: A HomeMedication ReviewPandey Awanish,Tripathi Poonam,Pandey Rishabh Dev.-------------------------------------------------------75-80Case ReportsL-Asparaginase Induced Central Venous Thrombosis in Acute Lymphoblastic LeukemiaLavanya S, Vijayan K, Abhay Dharamsi, Rajasekaran A Vijayakumar A-------------------------------------81-84Instructions to Authors -------------------------------------------------------------------------------------------85-88

EditorialDear Readers,We are indeed very delighted at the warm and overwhelming response that we have receivedfor our first issue of the journal. Thanks to all the authors for their contribution andreviewers for their timely co-operation. we look forward for the continued support.With Pharm.D course started in many Institutions and about to start in many more, we havegreater responsibility in choosing and publishing the right articles so that it can make animpression on the collaborating hospitals and clinicians on the role of pharmacist in patientcare.Our objective is to publish those articles which highlight the role of pharmacist as animportant member of healthcare team in bringing about better patient care.So once again, on behalf of the entire editorial team, I request allacademicians/researchers/practising pharmacists/students to contribute meaningfularticles that enrich the content of our journal and make it on par with any indexedinternational journals.Your feedback is most welcome for the improvement of our journal.Dr. Shobha Rani R.HiremathEditor-in-chief

APTIIndian J. Pharm. Pract. 1(2), Jan-Mar, 2009Clinical pharmacy practice in psychiatryChristopher P AldermanDirector, Pharmacy Department and Clinical Pharmacist (Psychiatry)Repatriation General Hospital, Daw Park, SOUTH AUSTRALIAAddress for Correspondence: chris.alderman@rgh.sa.gov.auInvited ArticleijoppAn evolution of pharmacy practicepatients. The movement to 're-professionalisation' ofIn an evolutionary process that has spanned several pharmacy involved practitioners accepting1decades, many pharmacists in primary and secondary responsibility and accountability for their input into thecare settings have shifted their focus from medication patient care process. 8supply functions (largely in the form of compounding A concept that is gaining increasing currency andand dispensing) to assisting other clinical staff with the credibility in relation to the role of clinical pharmacists inmanagement of patients and their drug therapy. This promoting optimal outcomes for patients is theclinical pharmacy practice began in the 1960s, when contribution of these practitioners in the facilitation of9hospital pharmacists began visiting the wards of quality use of medicines (QUM). QUM has been definedhospitals to check drug charts and proactively initiate as exhibiting three key componentsmedication supply without the need for prescriptions to judicious selection of therapeutic management options2,3be sent to the pharmacy. This practice allowed(considering the place of medicines in treating illnesspharmacists to establish a presence at the point of patientand maintaining health, and recognising the possibilitycare, in daily contact with doctors and nurses, andthat there may be better ways than medicine to managea particular situation)position themselves to offer advice and assistance withselection of a suitable medication, if a medicine is3, 4matters relating to drug therapy.considered necessary. This will involve considerationIn the context of ward pharmacy, pharmacists soonof the characteristics of the individual patient, thebecame involved in roles that included activities such as5clinical condition, risks and benefits associated withrecording patients' medication history and thetreatment options, the dosage and duration ofqualitative review of orders on patients' medicationtreatment, co-existing conditions, other therapies,6charts. These practitioners were starting to assume a rolemonitoring considerations, and costs for thethat helped to guide and inform prescribing, allowingindividual, the community and the health system as a7them to function as a part of a multidisciplinary team. whole.Although the re-engineering of pharmacy practice to a safe and effective use of medications toward-based model facilitated these changes, other achieve optimal health outcomes through monitoring,drivers also contributed. Rationing of public health funds minimizing misuse, over-use and under-use of medicreatedchanges for the hospital sector, so that only the cations, and ensuring that the patient or their carer havemost acutely ill patients were admitted to hospital, for the knowledge and skills to solve problems related toexample. This in turn meant that the acuity and the use of their medication(s).complexity of inpatient care progressively increased. The QUM framework extends the pharmaceutical careAdvances in pharmacotherapy led to the discovery and model and provides a mechanism for integrating clinicalwidespread implementation of entirely new drug pharmacists into the broader health care environment.treatment approaches for many clinical problems,It has the potential to address the issues that the moreprofession-specific pharmaceutical care model raisedcreating a rapid expansion in the scope of informationin terms of the integration of pharmacists into theabout the clinical applications for these drugs, theirhealthcare team. It also facilitates the routineadverse effects and drug interactions and the need forincorporation of pharmaceutical care as a component ofindividualisation of dosage to accommodate the needs ofemerging service delivery programs in hospitals, agedcareand primary health care settings and health careIndian Journal of Pharmacy Practiceteams. It is important, therefore, that the uniqueReceived on 12/03/2009Accepted on 12/03/2009 © APTI All rights reservedcontribution of clinical pharmacists that results from the1

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009training and skills developed in practice should be widely13Table 1. Perhaps the most noteworthy aspect of thisunderstood.comparison is that, although the data have been drawnMore than 30 years ago, it was already clear that the basis from a range of disparate sources such as North America,for pharmacy specialisation is related to a specialised Western Europe, Asia and Australia, there are severalknowledge of pharmacy-related sciences (biological and common themes that emerge. Importantly, each study10behavioural), rather than a particular practice setting. validates the early findings from the work initiated by thePharmacists practising in specialised roles have the WHO, confirming the high prevalence of mental illnessopportunity to provide a highly refined and effective type in various settings and providing a basis for a conclusionof pharmaceutical care in a context where a generalist that this area has justifiably been selected by healthpractitioner may not have the opportunity to do so, policy makers as a high priority for the development ofproviding a unique avenue to a high quality and strategies that might be used to reduce the associateddistinctive contribution to the advancement of quality harm.use of medicines for highly vulnerable patients. A range It is clear that mental illnesses are very common. Thoseof pharmaceutical specialities have now been who are affected, experience significant disadvantagesacknowledged and are flourishing, including highly that are evident in terms of poorer health outcomes,focused areas such as oncology pharmacy, higher rates of premature death and enduring disability,radiopharmacy and psychiatric pharmacy. The role of socioeconomic disadvantage and poor quality of life.psychiatric pharmacists in patient care has been People with mental illness are significant users of health11extensively advocated, and this type of practice model services, having frequent and lengthy hospitalisationshas been shown to improve clinical outcomes and reduce and requiring extensive medication therapy.psychotropic medication-related morbidity. 12 Polypharmacy is common amongst those withRationale for clinical pharmacy in psychiatrypsychiatric illnesses, and the drugs that are used are oftenExtensive previous research has addressed the of low therapeutic index and with considerable potentialprevalence of MRPs in hospitals and the community, and to cause significant medication-related problems.the utility of clinical pharmacy services as a means to Fundamentally, it is also clear that pharmacists, by naturemitigate medication-related harm: a detailed discussion of their training, experience and skills developed throughof this research is beyond the scope of discussion here. ongoing clinical practice, bring a unique perspective toThe potential impact of the implementation of specialist the care of patients with mental illnesses, in this wayclinical pharmacy services would be expected to be enhancing health outcomes through the prevention,influenced not only by the utility of the service delivery detection and resolution of medication-related problems.model, but also the prevalence of mental illnesses and the The integration of specialist pharmacists into adisability associated with them. With respect to quality multidisciplinary team caring for patients with complexuse of medicines initiatives in a public health sense, psychotropic pharmacotherapy needs allows thepriority must be given to areas in which adverse health application of the unique skills and experience of theseoutcomes and medication-related harm have the greatest practitioners in situations where that positive impact ofpotential to cause death, disability, compromised quality the services can be expected to be highest. It is desirableof life and adverse societal consequences, including for pharmacists to have distinctive role inincreased treatment costs, increased health service multidisciplinary mental health treatment teams,utilisation and other unfavourable economic outcomes working in cooperation with consumers and clinicians assuch as loss of productivity.brokers of specialised knowledge in clinical pharmacyThere has been a rapid growth in information about theand therapeutics, and integrating this with insight intoepidemiology, severity, and social and economic influpathophysiologyand an understanding of life challengesences of mental disorders around the world. The faced by patients with severe and chronic psychiatriccompelling and consistent nature of the information that illnesses.is available to guide policy and to influence directions in Evidence for the benefits of clinical pharmacy inhealth service delivery demands that the detection, psychiatryprevention, early management and follow-up of mental Research into the use of psychotropic drugs hasdisorders rate as concerns that equal other major health identified important roles for clinical pharmacists in thepriorities. Key research in this area has summarised in14management of psychiatric illness. Polypharmacy is2

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Overall, there now appears to be ample evidence that theprovision of clinical pharmacy services in the psychiatriccontext is justifiable, both form an economic point ofview, and more important, to help assure safe andeffective drug therapy for patients affected by mentalillness. The challenge is for practitioners to develop andsustain a practice model that can allow the delivery ofthese services, both in hospitals and in the communitysector. Inherent to this challenge is the need to devisepersuasive business cases that can be used in influencepayors and governmental bodies, so that these servicescan eventually become routinely available where needed.A framework for the delivery of clinical pharmacyservices in psychiatryAlthough other systems have been proposed, theconceptual framework that had its foundations in thework relating to the pharmaceutical care model has beenwidely embraced as a basis for the work of clinicalpharmacists in many settings. Strand et al. define amedication-related problem as 'any undesirable eventexperienced by the patientthat involves or is suspected toinvolve drug therapy and that actually or potentially29interferes with a desired patient outcome'. Using thismodel, pharmacists can base their clinical practicearound the prevention, detection, documentation andresolution of drug-related problems (DRPs). Theoriginal eight categories of DRP proposed in this systemare outlined with examples in Table 2.The current and active set of clinical pharmacy practicestandard from the Society of Hospital Pharmacists of30Australia (SHPA) was disseminated in 2004, anddescribes clinical pharmacy practice as the practice ofpharmacy in the context of multidisciplinary healthcareteam, directed at achieving quality use of medicines.Each of the clinical pharmacy functions outlined in theSHPA practice standards are directly applicable in thecontext of psychiatry, and include, but are not limited to:active participation in the management of individualpatientsassistance with the application of the best availableevidence in daily clinical practicecontribution of clinical knowledge and skills to thehealthcare teamidentification and reduction in risks associated withmedicines useinvolvement in the education of patients, carers, andother health professionals and involvement inresearch.The guidelines provide information about a range ofactivities that are components of contemporary clinicalpharmacy practice. These include those activities that areoriented towards the management of DRPs for theindividual patients – measures such as obtaining anaccurate medication history, assessment of currentmedication management, clinical review, therapeuticdrug monitoring, ward round participation, provision ofmedicines information to health professionals andpatients, adverse drug reaction management and others.In addition, the guidelines outline other aspects ofclinical pharmacy practice that although not focusedupon individual patient outcomes, still have directrelevance for psychiatric pharmacy practice. Theseinclude clinical research, teaching and quality assuranceactivities.Practical implementation of clinical pharmacyservices in psychiatryParticularly, if a practitioner has not had experience in thefield of psychiatry, the implementation of clinicalpharmacy services in a psychiatric unit can prove to be adaunting task. If there is no existing base to build upon,the best advice would be to start with modest aims, andwork steadily to build relationships with clinicians andpatients. Take every opportunity to participate ininterdisciplinary meetings, and to learn from theexperience and wisdom of medical, nursing andparamedical colleagues. Listen actively and carefully toinformation presented in multidisciplinary meetings, andunderstand that a holistic approach to patient care mustbe used to underpin the provision of clinical pharmacyservices. It is important to be able to acknowledge that insome cases, drug therapy (although possibly important)is not the only way to approach the management ofpsychiatric illnesses: psychological therapy, communitybased support, counselling, and the provision of practicalassistance in difficult times can be vital to the success ofoverall treatment.In some cases, it may be necessary to prioritise andprogressively implement clinical pharmacy services in away that is commensurate with the resources available.Under these circumstances, it is vital to ensure that basicfunctions with high impact upon patient outcomes areafforded the highest priority. Medication chart review,assistance through the provision of high quality druginformation, adverse drug reaction and drug interactionscreening, and work directly at ensuring the patients havean adequate understanding of their medications are themost important functions,as well as making sure thatthere are adequate supplies of medication available to thepatient, and that the patient has the insight and motivation4

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009In many cases, enlisting the support of family or closefriends of the patient can assist with these objectives. Aspractitioners begin to accumulate increasing experiencein psychiatric clinical pharmacy practice, they developgreater understanding of the special challenges involved:these include communicating with the mentally impairedpatient, recognising a patient who might be a danger tothemself or to others, dealing with issues relating tosubstance abuse (more common amongst patients withsevere psychiatric illness), and problems in helpingpatients to adhere to the prescribed therapy. Althoughclinical pharmacy practice in psychiatry is challenging,it is certainly rewarding in equal measure. In choosing towork in this field, a pharmacist chooses to deal withpatients who are often both chronically and severelyphysically and mentally unwell. There is extensivepolypharmacy with drugs of low therapeutic index.Serious adverse drug reactions and drug interactions arecommon. Mentally ill patients are amongst thevulnerable and underprivileged in any society: arguablythere is no higher calling in clinical pharmacy thanworking for the protection and assistance of these people.Table 4.1Key findings of epidemiological studies of mental illnessStudy Setting Key findingsGlobal Burden of Disease Worldwide Unipolar depression leading cause of disabilityBurden of Disease & Injury inAustraliaNational Survey of Mental Healthand Wellbeing of AdultsMental Health Disorders inAustralian VeteransMental Health: Report of theSurgeon GeneralMental Health Supplement to theOntario Health SurveyNational Psychiatric MorbidityNetherlands Mental Health Surveyand incidence studyTaiwan PsychiatricEpidemiological ProjectAustraliaAustraliaAustraliaUSACanadaBritainNetherlandsTaiwanMental disorders account for 30% of non-fataldisease in Australia. Depression and dementiasforemost causes of disability caused by mentalillness18% of Australians affected by key mentalillnesses Health and during the preceding 12months. 34.5% Wellbeing of adults experienceddisability.GAD, PTSD, Depression and alcohol abuse mostVeteran Community (Veterans) common. PTSDaccounts for > 50% of accepted mental healthclaims.One-year prevalence of diagnosable mental illnessapproximately 22-23%. Prevalence for anxietydisorders and mood disorders 16.4% and 7.1%respectively.18.6% affected, 14.2% with one disorder, 4.5%two or more disorders. Anxiety disorders (12.2%),affective disorders (4.5%) and substance usedisorders (5.2%) most prevalent.16% of subjects met screening criteria for mentaldisorders Surveys of Great Britain. No differencesamongst geographical regions of Great BritainLifetime prevalence of 41.2% and 12-monthprevalence 23.3% for psychiatric disordersLifetime prevalence estimates of 16-28%depending upon setting.5

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table 2. Categorisation of medication-related problems (after Strand et al.)Indication without drug therapyThe patient has a medical problem that requires medication therapy (an indication formedication use) but is not receiving a medication for that indication.Patient with heavy alcohol abuse but no thiamine has been ordered.Drug use without indicationThe patient is taking a medication for which there is no medically valid indication.Patient with acute agitation in hospital that has resolved post-discharge continuestreatment with tranquillisers initiated as an inpatient.Improper drug selectionThe patient has a medication indication but is taking the wrong drug.Delirium due to a urinary tract infection has been diagnosed, and antibiotic therapy hasbeen prescribed, but the organism involved is not sensitive to the antibiotic that has beenchosen.Sub-therapeutic dosageThe patient has a medical problem that is being treated with too little of the correctmedication.After initiation of an antipsychotic drug, blood glucose concentrations remainunacceptably elevated despite the use of insulin; dosage must be increased to achievedesired control.Over-dosageThe patient has a medical problem that is being treated with too much of the correctmedication.A patient is prescribed a very large dose of an antipsychotic drug: the magnitude of thedosage does not create additional antipsychotic benefit but generates severeextrapyramidal side effects.Adverse drug reaction (ADR)The patient has a medical problem that is the result of an ADR or adverse effect.The patient develops nausea, vomiting and diarrhoea as a result of treatment with anantidepressant.Drug interactionThe patient has a medical problem that is the result of a medication-medication,medication-laboratory, or medication-food interaction.Elevated serum haloperidol concentration with toxicity secondary to hepatic enzymeinhibition arising from SSRI treatment.Failure to receive a drugThe patient has a medical problem that is the result of not receiving a medication thatwas intended as a part of the designed treatment regimen.Patient is prescribed an expensive, non-subsidised drug therapy and has not received anycounselling about the expected benefits of therapy. The patient does not have theprescription filled and does not adhere to the established treatment plan.6

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009References1 Taylor K, Nettlesdon S, Harding G. Sociology for health facilities. Hospitals 1977; 51: 71–74.ndpharmacists: an introduction. 2 ed; Taylor and 17 Berchou RC. Effect of a consultant pharmacist onFrancis, New York, USA; 2003.medication use in an institution for the mentally2 Anderson S. The state of the world's pharmacy: a retarded. Am J Hosp Pharm 1982; 39: 1671 – 1674.portrait of the pharmacy profession. J Interprof Care 18 Saklad SR, Ereshefsky L, Jann MW, Crimson ML.2002; 16: 391 – 404.Clinical pharmacists' impact on prescribing in an3 Kirk EG. Ward pharmacist - regional pharmacist. acute adult psychiatric facility. DICP; 1984; 18: 6324Aust J Hosp Pharm 1971; 1:27 – 30. –634.Calder G, Barnett JW. The pharmacist in the ward. 19 Stanislav SW, Barker K, Crimson L, Childs A.Pharm J 1967; 198: 584 -586.Effects of a clinical psychopharmacy consultation5 Francke GN. Evolvement of "clinical pharmacy".service on patient outcomes. Am J Hosp PharmDrug Intell Clin Pharm 1969; 3: 348 – 354.1994; 51: 778 –7 81.6 Borgsdorf LR, McLeod DC, Smith Jr WE, Tatro DS.20 Baigent, B. Evaluation of clinical pharmacy in aImplementing clinical pharmacy services an AJHPmental health unit. Pharmaceutical Journal 1993;roundtable discussion. Am J Hosp Pharm 1973; 3:250: 150 – 153.672 – 682. 21 Cloete BG. Costs and benefits of multi-disciplinary7 Cousins HD, Luscombe D. Re-engineering pharmacymedication review in a long-stay psychiatric ward.practice. Forces for change and the evolution ofPharmaceutical Journal 1992; 249: 102 – 103.clinical pharmacy practice. Pharm J 1995; 225: 771 22 Lobeck F, Traxler WT, Bibinet DD. The cost-–77 6.effectiveness of a clinical pharmacy service in an8 Hepler CD. The third wave in pharmaceuticalout-patient mental health clinic. Hosp Communityeducation: the clinical movement. Am J Pharm EducPsychiatry 1989; 40: 643 – 645.1987; 51: 369 – 385.23 Dorevitch A, Perl E. The impact of clinical pharmacy9 Commonwealth Department of Health, Housing andinterventions in an acute psychiatric hospital.Community Services. A policy on the quality use ofJournal of Clinical Pharmacy and Therapeuticsmedicines. Canberra: Commonwealth Department of1996; 21: 45 - 48.Health, Housing and Community Services; 1992.24 Ewan MA, Greene RJ. Evaluation of mental health10 Anon. Preliminary report of the task force oncare interventions made by three communityspecialties in pharmacy. J Am Pharm Assoc 1974; 14:58 – 60.pharmacists - a pilot study. Int J Pharm Pract 2001; 9:11 Augustin SG, Puzantian T, Caley CF, Marken PA, 225 –2 34.Richards AL, Levin GM. Psychiatric pharmacists.25 Haw C, Stubbs J. Prescribing errors at a psychiatricAm J Psychiatry 2001; 158.hospital. Pharmacy Prac 2003; 13: 64 –6 6.12 Canales PL, Dorson PG, Crismon ML. Outcomes 26 Stubbs J, Haw C, Taylor D. Prescription errors inassessment of clinical pharmacy services in a psychiatry–a multi-centre study. J Psychopharma-psychiatric inpatient setting. Am J Health-Sys Pharm col. 2006 Jan 9; [Epub ahead of print]27 Alderman CP. A prospective analysis of clinical2001; 58: 1309 – 16.13 Alderman CP. Doctoral research thesis: Specialist pharmacy interventions on an acute inpatientclinical pharmacy services in the care of patients with psychiatric unit. J Clin Pharm Ther 1997; 22: 27 - 31.psychiatric illness: An assessment of the contribution28 O'Hare JD, McKee HA, D'Arcy PF. Analysis of drugto optimal health outcomes and implications forinformation queries received by the pharmacy in apharmacy practice. University of South Australialarge psychiatric hospital. J Clin Hosp Pharm 1984;2008.9:139 –1 42.14 Psychotherapeutic medication in Australia: report of 29 Strand LM, Morley CP, Cipolle RJ, Ramsey R,the Senate Community Affairs Reference Committee. Lamsam GD. Drug-related problems: their structure(1995) Canberra, AGPS.and function. DICP 1990; 24: 1093 –1097.15 Lacro JP, Jeste DV. Physical co-morbidity and 30 Dooley MJ, Bogovic A, Carroll M, Cuell S, Galpolypharmacyin older psychiatric patients. Biol bratith K, Matthews H. SHPA Standards of practicepsychiatry 1994; 36: 146 –152.for clinical pharmacy. J Pharm Pract Res 2005; 35:16 Stimmel GL. Clinical pharmacy services in mental 122 – 146.7

APTIijoppGenesis, Development and Popularization of Doctor of Pharmacy(PharmD) Education Program at the Global level - A study based onthe story from 1955 to 2009.1 2 3 4Revikumar K.G , Mohanta. G.P , Veena.R , Sonal Sekhar1. Principal, Amrita School of Pharmacy, Amrita University, AIMS, Edappally, Kochi, Kerala. 682 0262. Professor of Pharmacy Practice, Annamalai University, Chidambaram, T.Nadu,3. Sr.Lecturer, College of Pharmaceutical Sciences, M.G.university, Ettumannoor, Kottayam. Kerala4. Department of Pharmacy Practice, Amrita School of Pharmacy, Amrita University, Kochi. KeralaAddress for Correspondence: kg.revikumar@gmail.comAbstractThe concept of clinical pharmacy was introduced in pharmacy profession by the American Hospital pharmacistsduring the period 1920-1940, though the term 'clinical pharmacy' as such was not coined during those days.Clinical pharmacy as discipline evolved in USA from a combination of factors that contributed for thedevelopment and achievements in the area of hospital pharmacy. The introduction of PharmD in the Universityof California at San Francisco in 1955 contributed for the overall growth and popularization of clinicalpharmacy. By 1980s the PharmD became a sought after course in the US. The American Association of Collegeof Pharmacy (AACP) and the Accreditation Council for Pharmaceutical Education adopted PharmD as theessential and basic qualification required for the practice of pharmacy. Along with the regular PharmD, othernon-traditional programs like post baccalaureate PharmD were also introduced and PharmD got migrated toother parts of the world. When the Foreign Pharmacy Graduation Equivalency Committee (FPGEC) in the USmandated a 5 year pharmacy graduation program to be eligible to the Foreign Pharmacy Graduation EquivalencyExamination ( FPGEE), pharmacists from other countries particularly Asian countries including India got upset.All this prompted Indian authorities too to think of introducing PharmD. Finally the PharmD program wasinitiated in India in 2008 in few selected institutions approved by the Pharmacy Council of India. In spite of thelimitations of the Indian PharmD structure and the curriculum, the program will develop to one of the best suchprograms in the world in the years to come.Key words: PharmD, Doctor of Pharmacy, Pharmacy Practice, PharmDr.INTRODUCTIONthThough public pharmacies started during the 12 century needs of pharmacists.in Italy, France and other parts of the world, the first The concept of clinical pharmacy was first developed inpharmacy college was established in 1777 in Paris. In America. From the period of Jonathan Roberts in 17521803 six schools of pharmacy were started in France and (when he was appointed as the first hospital pharmacistprivate pharmacy education institutions arose in 1808 in in Pennsylvania hospital in North America) to 1920,Bavaria in Germany. It was in 1821 that the Philadelphiahospital pharmacy did not make significantCollege of Pharmacy admitted the first batch ofdevelopments or achievements in USA, that warrantspharmacy students in America. With the starting ofspecial mention. The post-1920 period, particularly thepharmacy institutions like Philadelphia College ofPharmacy, Massachusetts College of Pharmacy ( 1823)1940 to 1970s, witnessed many scientific developmentsand New York College of Pharmacy (1829) the global and achievements in the area of American Hospitalfocus of pharmacy eduction took an orientation towards Pharmacy. It was during this golden era of the AmericanAmerica. They could initiate time and again many Hospital Pharmacy that the clinical pharmacy originatedinnovative programs aimed at the future prospects and as a superspeciality of hospital pharmacy.In fact, ClinicalIndian Journal of Pharmacy PracticeReceived on 11/03/2009Accepted on 11/03/2009 © APTI All rights reservedIndian J. Pharm. Pract. 1(2), Jan-Mar, 2009Invited ArticlePharmacy as a discipline, evolved in America from acombination of factors like innovations in the disciplineof hospital pharmacy since 1920s, growth of clinical8

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009pharmacology since 1940s, formation of the American By 1980s, the authorities in US adopted PharmD as aSociety of Hospital Pharmacists(ASHP) in 1942, national professional degree program and by 1992, theinnovative teaching programs introduced in 1940s and AACP and the various pharmacy professional50s, and the decline of pharmacology instructions in organizations in America took a joint decision to makemedical schools. The introduction of PharmD program Pharm D as the minimum requirement for practice ofcontributed effectively for the development and Pharmacy in USA. Since the graduating class of 2006,popularisation of clinical pharmacy as a speciality of the BS Pharm degree has been completely replaced bypharmaceutical sciences. More over, the distributive PharmD degree in USA(Carrie 2008). All theseaspects of the pharmacy profession was entrusted to the developments have positively influenced the pharmacypharmacy technicians (Tse CS 2007).educational institutions and authorities throughout theGenesis of PharmDworld to take proper precautions at their countries.Hospital pharmacy attained new status at the University Influence of American system in other countries.of Michigam under the chief of their hospital pharmacy In 1992, the American Association of Colleges ofservices Harvey AK Whitney Sr in the late 1920s and Pharmacy (AACP) house of delegates voted to supportearly 1930s. In 1942 when he started the ASHP, his vision a single entry level educational program at the doctoralof pharmacy got percolated into the pharmacy level (PharmD). The national organisation that accreditscommunity of USA and other parts of the world pharmacy degree programs the Accreditation Council for(Mc Leod 2006). However, it was a surprise to many Pharmaceutical Education (ACPE) endorsed thepharmacy professionals in various parts of the world, decision of the AACP. However, till 1998, the Americanwhen a pharmacy program of study leading to the Universities and Pharmacy Schools were runningprofessional degree, Doctor of Pharmacy (Pharm.D.), programs like B.S (Pharmacy) / B.Pharm and PharmDwas initiated in the University of California at San simultaneously. In 1998, orders were issued to allFrancisco (UCSF), USA in 1955. Though the clinical American Universities to replace their B.S (Pharmacy)pharmacy concepts were discussed and debated in the and B.Pharm programs with PharmD to make thecountry from 1940s itself, the take-off of the PharmD in prospective pharmacists eligible for practice ofUCSF was not smooth and resistance free. The program pharmacy. The adoption of PharmD as the nationalhad to face some unfriendly reactions and resistances pharmacy education program to practice pharmacy infrom certain corners within the country. But many other USA was the result of the success story of practiceuniversities started to adopt the PharmD in the 1960s. oriented, service based and patient focused model ofSome other Universities including the University of pharmacy practice at the community and hospital levels.Kentucky had also taken leading roles in developing Advantages of PharmD programPharmD helps to develop abilities and skills requiredClinical Pharmacy programs in the world. Due to thei) To practice pharmaceutical care, the concept ofinnovative thinking of people like Paul F Parker, manywhich is based on sharing the responsibility for theclinical pharmacy activities were introduced inout comes of drug and related therapy.pharmacy in the 1960s. Inspired from the success of ii) To effectively communicate with patients andWhitney's experiment of Drug Information center in health care professionals.Michigan University, Paul F Parker opened the first iii) To scientifically conduct patient interview with theDrug Information Center at a Pharmacy School in 1962. objective of developing patient data base.The first hospital wide unit dose distribution program in iv) To be competent to conduct research studies onthe country was also initiated at the University of drugs and patients in specific areas of interest.Kentucky in 1965. In 1968, the pharmacy residencyv) To be able to design, implement and evaluateprogram was started that awarded both PharmD degreevarious research projects in health care.vi) To refine pharmacy practice skills throughand residency certificate.evidence-based concepts.It took about two decades for getting PharmDvii) To inculcate problem solving skills.popularised in USA and other parts of the world. In 1973 viii) To be able to take up projects and programs in theUCSF started Department of Clinical Pharmacy as an area of health sciences with special focus onindependent unit, which was responsible for the pharmacoeconomics, medication error and phardevelopmentof the first clinical pharmacy curriculum macovigilance.in the world. Today, the clinical pharmacy residency ix) To promote and practice prudent and rational useprogram of UCSF is the largest in USA.of medicines aimed at patient care.9

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009PharmD follows a multi-disciplinary curriculum that pharmacist profession in Portugal called, "Pharmacistscan produce pharmacists with sufficient mental acuity to Order" or in Portuguese "Ordem dos Farmacêuticos". Itdifferentiate their position from that of the traditional and is equivalent to the residency of Indian programs. Afterorthodox role of dispensers of medicines.the enrollment the title of Doctor of Pharmacy is issued.Increasing emphasis on improving quality of medication Afterwards, Pharmacists can pursue their career in ause and enhancing medication safety have dramatically limitless number of professional areas that range fromincreased the demand for clinical pharmacy and the community pharmacies, drug development, healthPharmD program in the US. This is the reason why they research, biotechnology to areas such as forensichad initiated a well planned project in the early 1980s sciences, food analysis and toxicology. The student canitself for introducing PharmD as the basic qualification also choose to become a specialist in activities likestfor practice by the beginnig of the 21 century. They had Pharmaceutical Industry, Pharmaceutical Regulation,given sufficient opportunities and facilities, like Hospital Pharmacy, and Clinical Analysis. Each one ofintroduction of non-traditional PharmD programs, for them require an additional 5 year professional studyall the existing pharmacists to get themselves converted program guided by a tutor in the respective area ofas doctors of pharmacy. The Universities framed their knowledge. This specialization is composed of regularown modules with practical approach for part-time and e- evaluations performed by the professional order, whichlearning process of PharmD for existing licensed at the end of the 5 years performs an exam. After thepharmacists. Many colleges througout USA offered post- success at the exam, the Pharmacist then becomes abaccalaureate PharmD as an additional degree that specialist, respectively, an Industrial Pharmacist,offered clinical course work and practical training in Regulations Pharmacist, Hospital Pharmacist, andclinics and hospitals.Clinical Analyst.PharmD in other countriesIn the Czech Republic, the title is known as PharmDr.The first Canadian PharmD was initiated at the(Pharmaciae doctor). The Pharm Dr is in fact a diplomaUniversity of British Columbia (U.B.C.) in 1991. Thewhich is different form the Indiana diplomas. The PhD isCanadian PharmD program is a post-baccalaureatealso a diploma in Czech. The PharmDr. can be obtainedprogram of two years ( academic period of 20 months)by pharmacists who had graduated in pharmacyduration. The PharmD programs in Canada are to be(Magister, Mgr.) and students have to study for aaccredited by the Canadian Council for the Accreditationminimum period of 5 years. Applicants must defend aof Pharmacy Programs (CCAPP). Students enrolled inresearch or experimental thesis, and pass a rigorousthe program are required to have graduated from aexamination. The PharmDr. title is predominantly aCanadian Council for Accreditation of Pharmacyprestigious thing.Programs (CCAPP) or an American Council of In France students are admitted to pharmacy educationPharmaceutical Education (ACPE) School with an programs (like medicine) through a competitiveaccredited teaching program. Those who have passed examination held at the end of the first year. The durationthe Pharmacy Examining Board of Canada (PEBC) of pharmacy education extends from a minimum ofEvaluating and Qualifying examinations can also join for 6 years to 9 years depending upon the options taken. Thethe Canadian PharmD. In Canada interestingly the maximum period of education is for students choosingPharmD program is offered in both English and French. hospital pharmacy or clinical pharmacy. Students mustPharm D is today very much popular in Europe. In specialize when entering the 5th year, and choosePortugal, Pharmacy studies can be chosen after between dispensing pharmacy, pharmaceutical industrycompleting 4 years of basic school, 5 years of preparatory or hospital internship. State diploma for the Doctorate ofschool, and three years of high school education. The Pharmacy, PharmD., is granted to pharmacists after theyprocess of admission is the same for all degrees from have completed a short thesis (experimental ormedicine to engineering. The student takes the Master's bibliographic). It is also possible to defend a "real"degree in Pharmaceutical Sciences which is equivalent research thesis for preparing à Ph.D.to the PharmD program in one of the many Pharmacy In Italy, the course of study leading to the Doctor offaculties. The masters program comprises a six year Pharmacy ( Dottore in farmacia) is of 5 year durationrigorous study. After completing the degree program and includes a guided professional apprenticeship in athe students enroll in the regulatory institution for the pharmacy.10

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009The education of pharmacists in the Netherlands requires duration of the program as seven years.a minimum of six years of university study. The Dutch In the Philippines, Pharm D was first started in 2005 atconsider the educational level of their current (M.Sc.) the Centro Escolar University (CEU) as a two year postDegree in Pharmacy to be comparable to the PharmD title baccalaureate program open to licensed pharmacists.in use in the United States. To become a hospital The CEU had started the College of Pharmacy in 1921.pharmacist,a 4-year residency program has to completed. Thailand is one among the few countries that had takenIn the United Kingdom, the PharmD is a relatively new early steps to make their national pharmacy educationpostgraduate program. It is considered as a doctorate program ready to adopt the American PharmD program.degree open to qualified pharmacists. It is offered by the Thailand signed an MOU with 9 American UniversitiesUniversity of Bradford, taking place over 3 years of paying a sum of 15 million US $ in 1984-85 to trainclinical practice followed by 2 years of research. It is also their teachers in pharmacy schools in USA. They hadoffered by the University of Portsmouth and the sent their pharmacy teachers to the AmericanUniversity of Derby.Universities for getting on the site exposure andIran Universities like the Tehran University, changed the experience in running PharmD program including itsPharmacy degree from Masters to doctorate (Pharm.D) various components. The first PharmD in Thailand wasand the duration of the study was increased to 5 years. initiated at Naresuan University in 1992.Graduates need to present and defend their theses in In Pakistan, traditionally the bachelor's degree indifferent fields of pharmacy and this adds another year to pharmacy was the first-professional degree for pharmacytheir studies and generally after 6 years students can practice. In 2003, the Pakistan Pharmacy Councilgraduate as Doctor in Pharmacy.mandated that a doctorate in pharmacy (Pharm D) wouldIn Lebanon, the first Doctor of Pharmacy (Pharm D) be the new first-professional degree. PharmD degree isdegree was awarded by the Lebanese University Faculty a professional degree that prepares the graduate forof Pharmacy (upon a decree by the Lebanese pharmacy practice with a duration of 5 years. Mostgovernment) to its graduating class of 19 students in universities in Pakistan are offering the PharmD program1992. The program was first established by Dr. Anwar such as Karachi University, Dow College of Pharmacy,Bikhazi, a Pharmacy graduate of the American Hamdard University, Baqai University, Federal UrduUniversity of Beirut with a PhD from the prestigious University, the University of Punjab, the University ofUniversity of Michigan. The 6-year entry level PharmD Lahore, Gomal University, the Islamia University ofprogram at the Lebanese University adopted the US Bhawalpur, etc. The qualified institutes are recognizedPharmD curriculum and training. Enrollment into the by the Pakistan Pharmacy Council. Provincial Pharmacyprogram is highly competitive with an average admission councils of Punjab, Sindh, NWFP and Balochistan issuerate of 20% of applicants. This was the leading PharmD Pharmacist Licenses (RPh). In all the countries whereprogram in the Middle East, which was followed by other PharmD is in existence, the PharmD curriculum ismirror copies of similar programs in Lebanon and similar but not identical. However, it is true that certainneighboring countries, such as the ones provided by the institutions/ universities give more emphasis to certainUniversity of Saint-Joseph (USJ) in Beirut and the subjects, and place less emphasis on others.Lebanese American University.Curriculum contents and goals- global scenario.Saudi Arabia started first Pharm D in 2001 at King The PharmD program has three main components.Abdualziz University (KAU) and later other institutions Didactic curriculum, laboratory works based on theand Universities like Ibn-Sina University, KFU, theory papers and the clinical rotations including clinicalQassim University, KSU College of Pharmacy at Riyadh, clerkship and residency. The didactic curriculumCollege of Pharmacy at Kharj, and Taif University also ensures a strong educational base for the clinicalstarted PharmD. Pharm D in Saudi is of six years component of the program. Unlike the other pharmacyduration including one year clinical rotations. According education programs, the didactic component of PharmDto the Saudi Commission for Health Specialties gives emphasis on pharmacotherapeutics,(SCFHS), if a student has taken PharmD within a pharmacokinetics and pathophysiology. The laboratoryminimum six years period, the graduate has a chance to works of the PharmD is very much similar to thefurther develop himself by taking Accredited Residency traditional B.Pharm program in the case of the generalTraining Program for one year duration, making the total and common subjects.11

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Arab countries like Egypt, Syria, Jordan, Saudi Arabia early 1980s. However, clinical pharmacy could make anwere intuitively conducting 5yr degree course impact in the pharmacy profession and the practice in(B.Pharm) since early 1990s and some of their India only in the 1990s. In the beginning, clinicalpharmacy colleges just changed the name of the course pharmacy was restricted to hospitals in India, but laterfrom B.Pharm to PharmD. Pakistan very smartly took spread to community settings. Today, Indian clinicalthe inadvisable shortcut by upgrading their degree to pharmacy also addresses industry-based issues likenew nomenclature of Pharm.D and increased 4 year to drug information, clinical trials, pharmacy journalism5 year duration. In some countries, including Pakistan and pharmacovigilance activities.the post-baccalaureate PharmD is of only one year The area of pharmaceutical sciences in India isduration and in most other countries, it is a two year developing day by day and the role of pharmacist is alsoprogram.undergoing major changes. The pharmaceuticalGenesis of Pharm D in India.industry in India has attained tremendous growth andThe pharmacy education in India is not much old. It wasdevelopment during the last three or four decades.initiated in Banaras Hindu University in 1932 by a thirtyWith growing internationalization of the pharmayear old youth, Mahadeva Lal Schroff popularly knownindustry and the globilization of the pharmacyas M.L. Schroff. He could start pharmacy education ineducation program, the standards of pharmacythe country just because of the encouragement andeducation need to be world class and the country is nosupport he got from Pandit Madan Mohan Malaviya, adoubt moving in that direction. The first effort innational figure and Vice chancellor of the Banarasintroducing PharmD in India was initiated inHindu University.In 1940, April the first M.Pharm course was started inTrivandrum Government Medical College in the 1990sthe Banaras Hindu University (BHU). Later, Schroffitself and in 1999 Dr.Revikumar K.G., Head ofworked as Principal of Birla College, Pilani duringHospital and Clinical Pharmacy, framed a curriculum(1949- 52) and was the Professor of pharmacy atfor starting PharmD in the University of Kerala,Saugar University (1958-60). In 1964, based on the Trivandrum with the help of some some Americaninvitation from Dr. Triguna Sen he organized the Universities (Fig1) and took it ahead. Though thedepartment of pharmacy at Jadavpur University, Board of Studies and the Faculty of Medicine clearedCalcutta. However, the growth of pharmacy education the proposal, it could not materialise due to somewas in the 'bonsai style' in the beginning. Even at the reasons at that time.time of independence there were only five pharmacyWhen the Foreign Pharmacy Graduation Equivalencycolleges in the country and it increased to 16 by 1967.Committee (FPGEC) in US mandated a 5 year pharmacyDuring the period 2000-2008 hundreds of newgraduation programme to be eligible to take the Foreignpharmacy degree colleges started in the country. ThePharmacy Graduation Equivalency Examinationnumber of degree colleges increased to around 900 by(FPGEE), quite naturally pharmacists from South2009. Only about 15 percent of the Indian Pharmacy Asian countries including India have got upset. ManyColleges are situated in the health care campus Indian Bachelor of Pharmacy graduates who hadattached to the hospitals or medical colleges.undergone the 4year B.Pharm course and went to USIn India, the post graduate pharmacists working in the for a job since 2003 were put in quandary. All thishospital pharmacies were engaged in different teaching prompted Indian authorities to think seriously about thepositions in the department of pharmacology of various introduction of PharmD in India.medical colleges. They were well respected and The Indian authorities could introduce the six yearaccepted by the medical students. Some academicians regular PharmD and the three year post baccalaureatein India, like Dr.P.C.Dandiya, Professors Gode and PharmD in 2008 in the country. The Gazette ofthGambir (Department of Pharmacology, Institute of Government of India, dated 16 May 2008 notified theMedical Sciences, BHU), Prof. R.D. Kulkarni norms for PharmD program. The current syllabus of the(Department of Pharmacology, Grant Medical College, PharmD include regular Pharmacy subjects and specificBombay) and Dr.B.D.Miglani (Delhi University) tried subjects like therapeutics and clinical pharmacy.to bring this evolution of clinical pharmacy in the West, Orientation and exposure in clinical, hospital andinto the Indian pharmacy profession in the 1970s and community pharmacy practices is also incorporated.13

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table1. Pharmacy Colleges approved by PCI for starting regular PharmD in 2008Sl.No Name of College University1. Department of Pharmacy Practice, AnnamalaiUniversity , T.N.Annamalai University, Annamalai NagarChidambaram, Tamil Nadu.2. Visveswarapura Institute of PharmaceuticalSciences, BangaloreRajiv Gandhi University of Health Sciences,Bangalore, Karnataka3. J.S.S College of Pharmacy, Mysore J.S.S University, Mysore, Karnataka4. K.L.E College of Pharmacy, Belgaum K.L.E University, Belgaum, Karnataka5. M.S Ramaiah College of Pharmacy, Bangalore Rajiv Gandhi University of Health Sciences,Bangalore, Karnataka6. Navodaya Education Trust’s N.E.T Pharmacycollege ,RaichurRajiv Gandhi University of Health Sciences,Bangalore, Karnataka7. Hyderabad Karnataka Education Society’sCollege of Pharmacy,GulbargaRajiv Gandhi University of Health Sciences,Bangalore, Karnataka8. Sri.Jagadguru Mallikarjuna MurugharajendraCollege of Pharmacy,ChitradurgaRajiv Gandhi University of Health Sciences,Bangalore, Karnataka9. B.V.V Sangha’s Hanagal Shri KumareshwarCollege of Pharmacy, BagalkotRajiv Gandhi University of Health Sciences,Bangalore, Karnataka10. J.S.S College of Pharmacy,Ootacamud J.S.S University, Mysore, Karnataka11. Sri Ramachandra College of Pharmacy,Chennai Sri Ramachandra University,Chennai, TamilNadu12. Sri.Ramakrishna Institute of ParamedicalSciences,CoimbatoreThe Tamil Nadu Dr.MGR Medical University,Chennai,Tamil Nadu13. Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka.Manipal14. Smt.Sarojini Ramulamma College of Pharmacy, Osmania University, Hyderabad, Andhra PradeshMahabubnagar15. Raghavendra Institute of PharmaceuticalEducation & Research,AnantapurJawaharlal Nehru TechnologicalKukatpally,Hyderabad, Andhra Pradesh16. Deccan School of Pharmacy, Hyderabad Osmania University, Hyderabad, Andhra Pradesh17. Talla Padmavathi College of Pharmacy, Kakatiya University, Andhra PradeshWarangal18. Bharat Institute of Technology,RangaReddy(Disst.)Jawaharlal Nehru TechnologicalKukatpally,Hyderabad, Andhra Pradesh19. St.Peter’s Institute of PharmaceuticalKakatiya University, Andhra PradeshSciences,Vidyanagar20. Sri.Venkateshwara College of Pharmacy, Osmania University,Hyderabad, Andhra PradeshHyderabad21. GIET School of Pharmacy,Rajahmundry Andhra University, Visakhapatnam, AndhraPradesh22. Malla Reddy College of Pharmacy,Osmania University,Hyderabad, Andhra PradeshSecunderabad23. Shri Vishnu College of Pharmacy,West Andhra University, Visakhapatnam, AndhraPradesh24. Vaagdevi College of Pharmacy,Warangal Kakatiya University, Andhra Pradesh25. P.Rami Reddy Memorial College ofPharmacy,KadapaJawaharlal Nehru TechnologicalKukatpally,Hyderabad, Andhra Pradesh26. Shri.Ramnath Singh Institute of PharmaceuticalSciences & Technology,GwaliorRajiv Gandhi Proudyogiki Vishwavidyalaya,Bhopal, Madhya pradesh27. Poona College of Pharmacy, Pune Bhari Vidyapeeth University,Maharashtra14

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009ththHospital rounds, clinical postings, training in 4 and 5year and the one complete year residency in the hospitalduring the last year of the course (sixth year ) can helpthe PharmD students get familiar with actual hospitaland clinical practice set-ups. However the curriculum forthe PharmD course as finalized by the Pharmacy Councilof India (PCI) require drastic changes taking intoconsideration the global and national scenario to make itmore effective and result oriented.The PCI in July 2008 invited applications for startingPharmD in India. Though it was done in a comparativelyhasty manner giving only minimum period to apply, theyhad received about 50 applications from states likeAndhra Pradesh, Karnataka, Tamil Nadu, Kerala,Maharashtra, Madhya Pradesh and Orissa andconducted the inspection in August. In September 2008,the PCI approved about twenty pharmacy institutionsfrom states like Tamil Nadu, Andhra Pradesh,Karnataka, Maharashtra and Kerala for startingPharmD course from the academic year 2008- 09.Subsequently few more institutions were approved forstarting the program. Some of these were given thepermission to start both PharmD and PharmD postbaccalaureate (See Table 1 and II).The pharmacy colleges have to fulfill the requirementsas fixed by the PCI like sufficient number of qualifiedfaculty, class rooms laboratories etc. Along with hospitalfacility (300 bed hospital) for starting the PharmD. In2008, the University Grants Commission (UGC) hassanctioned Rs.50 lakh to Annamalai University in TamilNadu to start PharmD program. They are the first tolaunch the PharmD in India. Immediately after startingthe PharmD, the Annamalai University initiated steps forhaving a tie-up with some American Universities. In2009 February Dr.James Scott from Western Universtity,California visited Annamalai University to study thesituation and the facilities available at the University forrunning the program. In that connection, Dr. Scott hasvisited and studied the facilities in some other centers insouth India like Amrita School of Pharmacy (AmritaUniversity, Kochi, Kerala), Alshifa College of Pharmacy(Calicut University, Kerala), KLE College of Pharmacy (KLE University, Belgaum) and Sri RamachandraUniversity, Chennai. In the years to come, the PharmDprogram in India will develop to one of the best suchprograms in the world as the country has the potential andfacility for the same.PharmD Tuition FeeThe tuition fee for PharmD varies from country tocountry, state to state, university to university andinstitution to institution. The tuition fee is highest incountries like USA. In Idaho State University (ISU) it is$12000 (about Rs 6 lakhs) per semester for non-residentsand 5000$ for Idaho residents. In Pakistan the fee isalmost uniform and is about Rs. 50000 per semester. InIndia the tuition fee on average rupees one lakh per yearin private sector. However, depending upon the facilities,infrastructure and other amenities the fee may increase ordecrease. In government institutions the fee is very less.Unfortunately, very few government institutions havetaken steps to start PharmD in India.Table.2. Pharmacy Colleges approved by PCI for starting Pharm.D (post baccalaureate) program.Sl.No Name of College University1. Dept. of Pharmacy Practice, Annamalai Annamalai University, Chidambaram,Tamil NaduUniversity T.N.2. Visveswarapura Institute of PharmaceuticalSciences,BangaloreRajiv Gandi University of Health Sciences, Bangalore,Karnataka3. J.S.S College of Pharmacy, Mysore J.S.S University, Mysore, Karnataka4. K.L.E College of Pharmacy, Belgaum K.L.E University, Belgaum, Karnataka5. J.S.S College of Pharmacy, Ootacamud J.S.S University,Mysore,Karnataka6. Sri Ramachandra College ofSri Ramachandra University,Channai,Tamil NaduPharmacy,Chennai7. Sri. Ramakrishna Institute of Paramedical The Tamil Nadu Medical University, Chennai, TamilSciences, Coimbatore8. Manipal College of Pharmaceutical Sciences,ManipalNaduManipal University, Manipal, Karnataka15

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Fig1. PharmD syllabus of University of Kerala framed in 1999 for starting the program in TrivandrumMedical College in 200016

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Future prospects.ASHP in 2003 issued a vision statement for pharmacy education, an idea or a necessity?. Iranian J Pharm Res.practice in American hospitals and health systems. It Available at: http://www.ijpr-online.com/ Docs/prescribes 6 goals and 31 objectives to be attained by 20021/IJPRe001.htm. September 5, 20072015. It motivates the ASHP members to advance the 12. Parthasarathi G, Ramesh M, Nyfort-Hansen K,profession to higher levels. In 2004, another visionary Nagavi BG. Clinical pharmacy in a South Indianstatement was launched by the Joint Commission of teaching hospital. Ann Pharmacother.Pharmacy Practitioners(JCPP). It ensures that 2002;36(5):927–932.pharmacists will be the health care professionals 13. Pedersen CA, Schneider PJ, Santell JP. ASHPresponsible for providing patient care that ensures national survey of pharmacy practice in hospitaloptimal medication therapy outcomes by 2015. Both settings: prescribing and transcribing 2001. Am Jthese position statements envisage that all clinical Health Syst. Pharm 2001;58:2251-2272.pharmacists and practicing pharmacists will have 14. Revikumar KG,Veena R. Clinical Pharmacy –Acompleted at least one year of residency training by the sought-after specialty: Chronicle Pharmabiz: Novyear 2020. The Indian PharmD has to be planned and 30, 2006. 65- 68.developed as a program giving sufficient opportunities 15. Salamzadeh J. Clinical pharmacy in Iran: where dofor residency and other hospital and clinical postings we stand?. Iranian J Pharm Res. 2004;3:1–2.promoting evidence based practice culture. The practice 16. Singh H. History of Pharmacy in India and Relatedand education have to move ahead in tandem. It is Aspects. Pharmacy Practice. Vallabh Prakashan,essential to provide sufficient opportunities for carrying Delhi. 2002;3.out real and innovative practice experiences in the 17. Smith WE. Clinical Pharmacy: Reflections andPharmD program. Experiences and lessons form other Forecasts. The Annals of Pharmacotherapy: 2007;countries show that prospects for the PharmD are much 41:325-328.better in India.18. Tse CS. Clinical Pharmacy Practice 30 years later.References The Annals of Pharmacotherapy. 2007;41: 116-118.1. Babar ZU. Pharmacy education and practice in 19. Yang E, Shin TJ, Kim S, Go Y, Lee S. ThePakistan. Am.J.PharmEduc. 2005;69(5).pedagogical validity for a six years curriculum in2. Babar ZU. Defining clinical pharmacy in Asia.E s s e n t i a l D r u g s 2 0 0 7 . Av a i l a b l e a t : pharmacy education. Korean J Med Educ.http://www.essentialdrugs.org/edrug/archive/2007 17(3):225–238.06/ Accessed September 5, 20073. Calvert RT. Clinical pharmacy- a hospitalperspective. Br J Clin Pharmacol 1998; 47: 231-2384. Carrie N, James GS. The development of clinicalpharmacy practice in the United States. IJHP 2008;45: 116-118.5. Department of Hospital & Clinical PharmacyS e r v i c e s M e d i c a l C o l l e g e H o s p i t a l ,Thiruvananthapuram. IJHP 1997 Sept-Oct XXXIV,5 175- 178.6. Jean FB, Patricia L. Hospital Pharmacy Practice: aCanadian Perspective, International PharmacyJournal 2002:16(1); 11- 13.7. Joint Commission of Pharmacy Practitioners..Future vision of pharmacy practice. WashingtonDC. 2008.8. Ghilzai K, Naushad M, Arjun DP. India to introducefive-year Pharm D program. Am J Pharm Educ.2007;71(2).9. Mc Leod DC. Contribution of the Annals ofPharmacotherapy in the development of clinicalpharmacy. The Annals of Pharmacotherapy 2006;40:109-111.10. Merchant SH. Clinical Pharmacy and WardPharmacy- Need of developing these services inIndian hospitals. The Indian Journal of HospitalPharmacy 1983. May June XX, 3 127-129.11. Mosaddegh M. Revision of Iranian pharmacy17

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIAbstractGood Pharmacy Practice in Chronic Disease ManagementNeelam Mahajanlecturer, MSIP C-4 Janakpuri, Delhi-58*Address for correspondence: neelam_4247@yahoo.comKey words: Chronic diseases, pharmaceutical care, Quality of life.ijoppChronic diseases have been reported to be leading cause of death in world. The WHO report had proposed the globalgoal to reduce the projected trend of chronic disease death rates by 2% by 2015. Various individual, institutional &organizational healthcare interventions in academic, hospital and community settings are required and have beenreported to achieve this aim. Ironically, the provision of pharmaceutical care to the patient of chronic diseases bycommunity pharmacist in community settings had remained a far reality on one hand and on the other hand theescalating healthcare costs, unstable disease state, changing disease patterns, multiple complications requiringadministration of multiple drugs ,complex dosage regimens, non compliance to therapy, associated multiple psychosocial problems make chronic disease and chronic disease therapy management problematic. Quality of life of thechronic disease patients and reduction of chronic disease death rates depends not only on the quality of drugssupplied by community pharmacies but also on the necessary psycho social support and pharmaceutical care ofpharmacist. It is proposed that, community pharmacies should be projected as places where the chronic diseasepatients can get pharmaceutical care. Adherence to good pharmacy practices by community pharmacies is viableintervention required to maintain the quality of therapy received by the patients of chronic diseases.INTRODUCTIONChronic diseases have been reported to be leading cause tions due to adverse drug reactions leading to reduction inof death in world. The WHO report had proposed the overall healthcare cost and agony of chronic diseaseglobal goal to reduce the projected trend of chronic patients. In other words, the focus of the communitydisease death rates by 2% until 2015. Various individual, pharmacy practice should be oriented towards qualityinstitutional & organizational healthcare interventions pharmaceutical products first, then to a well informedare required and have been reported to achieve this aim. patient equipped with necessary knowledge ofTo achieve this aim;medication prescribed by him/her & lastly to provision1. Good manufacturing practices are required to be of pharmaceutical care.followed to produce cost effective quality drugs for Ironically, the provision of pharmaceutical care to thethis segment.patient of chronic disease by community pharmacist had2. Adherence to good pharmacy practices in community remained a far reality. It is because of the minimumpharmacies is required to maintain the quality of eligibility of qualification for a registered pharmacist istherapy received by the patient. It is because D.Pharma and Diploma Holders in India receivecommunity pharmacy is the end point of the channel of practical training which is inadequate to train them in thedistribution & a vital link between suppliers of quality provision of pharmaceutical care to the patients. They aredrugs & the patients. If the pharmacist in-charge of the theoretically ill equipped due to teaching of obsoleteCommunity Pharmacy follows Good Pharmacy subjects in the light of slow curricula revisions. MajorityPractices, then the benefits of the medication therapy of the retail pharmacy outlets are either owned byreceived by the patients are maximized while the diploma holders or run by diploma holders. Hence, it isadverse side effects are minimized. This is followed common practice to witness the absence of two vitalby reduction in the number of unnecessary hospitalizaelementsof pharmacy practice i.e. patient andprofessional practice.Traditionally, retail pharmacies are the communityIndian Journal of Pharmacy PracticeReceived on 06/09/2008 Modified on 11/09/2008pharmacies where OTC and non OTC products forAccepted on 14/09/2008 © APTI All rights reservedchronic disease are sold.The pharmacist in-charge of18

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009community pharmacies, though theoretically well versedlack the necessary competencies and skills to educate thepatient about the therapy received for the chronic diseaseand to provide pharmaceutical care through services likepharmacovigilance. Even if the retail pharmaoutlets/community pharmacies are manned by pharmagraduates, the situation remains more or less the same.It is because though theoretically better equipped thendiploma holders, they show total lack of clinicalorientation due to industrial orientation of B.Pharmsyllabi & lack of clinical training. Though introduction ofPh.D. programme is heartening yet it is required to giveclinical training to the large pool of existing registeredPharmacists running community pharmacies.Good community pharmacy practicesSince Chronic Disease Management is problematic dueto the administration of multiple drugs to the patients, itrequires speciality pharmacies dedicated to variouschronic diseases like Cancer, AIDS, Diabetes etc.. Thishighlights the need of having super special communitypharmacies. Such Pharmacies will demand pharmacistwith clinical training in super-specialities of chronicdiseases. Though a structured continuing educativeprogramme for registered pharmacists in India is missingyet by attending various workshops in clinical training,symposia, conferences etc. and by means of internet, theregistered pharmacist can stay in touch with latestadvancement in chronic disease management. The superspecialitypharmacies catering to particular chronicdisease patients should provide the related medicines andinformation to the patients. The patients should getindividualized information on therapy. Such pharmaciesshould have the element of professional pharmaceuticalare where pharmacist can act as a warrior and keep undercheck the unwanted adverse drug reactions due topolypharmacy in chronic diseases. These pharmaciesshould cater to the disease specific pharmaceutical needsof chronic disease patients, should have A to Z of therequirement of all drugs, diagnostics and otheraccessories for routine and emergency management ofchronic diseases.All chronic diseases lead to psycho-social problems likeanxiety about hospitalization, restricted diet, diseaseprogression, financial problems, anger, depression,restricted movements etc. These psycho-social problemsand the complex dosage regimens of the drugsadministered, the unstable/serious disease state, nonadherence to therapy highlight the need ofpharmaceutical care and psycho social support ofpharmacist. The community pharmacies should beprojected as places where the chronic disease patients canget the necessary psycho-social support andpharmaceutical care. The Pharmacist should identifyand mobilize the strength and resources of patient toendure and manage their health concerns. This requires avigorous training of such pharmacist for patientcounseling. The retail pharma outlets should put upposters or distribute pamphlets to patients of chronicdisease to inform them about special patient counselingservices of the pharmacy. Such pharmacies should buildthe public opinion on the accessibility andapproachability of the community pharmacist as a wellinformed health care professional. These should also actas platform to spread awareness about the significance ofthe super-speciality pharmacies in provision ofprofessional pharmaceutical care in chronic diseases likehealth care screening services in detection andprevention of chronic diseases at early stages by referringthem to referral services.The patients should be given computer generatedinformation on the medications and the therapy receivedby the patients. The pharmacist should give spontaneousor planned detailed individualized medicationinformation and answer the queries of the patients ofchronic diseases related to prescribed therapy and thedrug product as per individual requirement. Thepharmacist should do value addition to the knowledge ofthe patient regarding proper and safe use of medicines forspecific chronic disease. The pharmacy should impartplanned education to chronic disease patients on themedications received in groups. The education of thegroups of Patients of such diseases can take place throughan interactive learning experience between thepharmacist & patients. Besides, the pharmacist shouldbe groomed to carry out detailed discussions to guide thepatients in management of their disease state and thetherapy prescribed for the same.The focus of counseling to the patients of chronicdiseases should be on active participation of the patientsin safe and proper use of medications & management ofspecific disease states rather than passive participation. Itis very important because of the agony suffered bychronic disease patients and the huge healthcare costsinvolved. This shifting of foci can lend to tremendousreduction in their agony and healthcare cost involved.The Pharmacist should encourage the filling of selfreporting forms of adverse drug reactions of drugsprescribed to chronic disease patient so that these can be19

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009checked in time & unnecessary hospitalizations can be global goals (proposed by WHO) of reduction of deathavoided. These forms should form an essential tool for rates due to chronic diseases by 2% until 2015.providing pharmaceutical care to such patients along Referenceswith medication cards issued to the patient. The1. Preventing chronic diseases: a vital investment,Medication cards should contain the information onWHO2. Chronic trouble: 60m Indians at risk over next tenmedications taken by these patients and their dosageyears, The Times of India, 19-02-06regimen. This can help the patient in recovering the3. Pharmacy practice changing times, new roles,medication. The physicians in the area of super-specialityChronicle Pharmabiz, p.31, 13-12-2007pharmacies should be contacted to publicize their 4. Playing pivotal in patient care, Chronicle Pharmabiz,professional services of patient counseling on disease p.33, 13-12-2007state and medication management of chronic disease 5. Patient counseling the magic spell for betterpatients. The advice of physicians can be used for further healthcare, Scientific Abstracts, p.512, 60th IPC,improvement of the counseling services of the Pharmacy. 2008Further, the Community Pharmacies should adopt the 6. Patient awareness in cardiac diseases-today's need,nearby community where the chronic diseases are more Scientific Abstracts, p.504, 60th IPC, 2008prevalent. The Pharmacist should educate the patients 7. A study of interventions made by clinicaland susceptible patients of chronic disease on the various pharmacists, Scientific Abstracts, p.509,, 60thaspects of these diseases. A host variety of activities IPC,2008can be stated by the pharmacy to promote healthy life8. The cancer pharmacist, p.505, Scientific Abstracts,styles and curb unhealthy practices in the community, top.527, 60thIPC, 20089. Shaping Pharmacy Profession, B.Suresh, Chroniclescreen masses for early detection of diseases and to givePharmabiz, p.20, 13-12-2007.psychosocial reassurance to the patients of chronicdiseases. A to Z of pharmaceutical care should beprovided to the patients of chronic diseases in adoptedcommunity. The Pharmacist should help the patient todevelop understanding on the role of medicines topromote good health, to take suitable decisions related tothe medications (their dosage regimen) prescribed, tomanage adverse side effects and drug interactions and tobecome a well informed partner in the management ofhis/her chronic disease state.ConclusionIf these good pharmacy practices are adopted inCommunity Pharmacy settings, then the mortality ratedue to Adverse Drug Reactions of the drugs administeredto patients of chronic diseases will be reduced. It isbecause, the community pharmacist by virtue of goodcounseling skills will ensure proper and safe use of drugsby patients of such diseases. This in turn, will maximizethe benefits of therapy and quality of life of chronicdisease patients will improve. The added benefits willinclude public recognition of the role of the pharmacist inthe management of their diseases and medication.Moreover, due to health promotion and health screeningactivities, the spread of chronic disease in susceptiblemasses can be brought under control. The net result ofthese good pharmacy practices in communitypharmacies will be reduction in death rates due to chronicdiseases in India, achievement of national goals and20

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIDrug Information Centre (DIC)-An Indian Scenario1 1 1 1 1 2Nitesh S Chauhan , Firdous , R Raveendra , Geetha J , B Gopalakrishna , Roopa Karki1R R College of Pharmacy, Bangalore-560090, India2Acharya & B.M.Reddy College of PharmacyAddress for correspondence: nikki_srms@rediffmail.comijoppAbstractDrug information centre refer to facility specially set aside for, and specializing in the provision of drug information& related issues. The purpose of drug information centre is to provide authentic individualized, accurate, relevantand unbiased drug information to the consumers and healthcare professionals regarding medication relatedinquiries to the nation for health care & drug safety aspects by answering their call regarding the all criticalproblems on dug information, their uses and their side effects. Apart from that the centre also provides in-depth,impartial source of crucial drug information to meet the needs of the practicing physicians, pharmacists and otherhealth care professionals to safeguard the health, financial and legal interests of the patient & to broaden thepharmacist role visible in the society & community. Number of drug information centers are being opened with theprospective of safe health care & drug safety which will surely serve the community & enhanced the role ofcommunity pharmacist. Information present in the current paper will not only enlighten the role of drug informationcentre but also focused on the rational use of drug.Key words: Drug information, health careINTRODUCTIONDrug information is the provision of a written and/ or catering to the information needs of nursing staff. Theverbal information about drugs and drug therapy in staffs of the drug information center were expected toresponse to a request from other healthcare provider, take an active role in the education of healthorganizations, committees, patients, public or professionals within the institution. In 1973, the firstcommunity.formal survey identified 54 drug information centers inDrug information service refers the activities undertakenthe USA. According to a report published in 1995, thereby pharmacists in providing information to optimizedare about 120 full-fledged pharmacist-operated drugdrug use. Drug information centre provides in-depth,information centers in the United States, which accept aunbiased source of crucial drug information to meet the 1broad scope of requests from health care professionals .needs of the practicing physicians, pharmacists and otherIndian scenariohealth care professionals. In the country like India where Recognizing the need to provide organized drugthe national polices are industry focused rather than information to health care professionals as well ashealth focused, it became crucial to enlighten the role of consumers, the WHO India Country Office indrug information centre to spread the awareness aboutcollaboration with the Karnataka State Pharmacydrug information services & rational use of drug.Council (KSPC) is supporting the establishment of 5Global scenarioIn 1962, the first drug information center was opened at drug information centres. These centers have beenthe University of Kentucky Medical Center and was established in Haryana (Sirsa), Chhattisgarh (Raipur),intended to be utilized as a source of selected, comprehe- Rajasthan (Jaipur), Assam (Dibrugarh), and Goa2nsive drug information for staff physicians and dentists to (Panaji) .allow them to evaluate and compare drugs besides The Karnataka State Pharmacy Council established itsDrug Information Centre (DIC) in August 1997 todisseminate unbiased drug information to healthcareIndian Journal of Pharmacy Practiceprofessionals. In India, this was the first independent DICReceived on 09/09/2008 Modified on 19/09/2008Accepted on 23/09/2008 © APTI All rights reservedstarted by Karnataka State Pharmacy Council to21

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009provide unbiased drug information to healthcare from FDA and other agencies.professionals. The centre is registered with IRDIS, an Drug Information Centre works towards in2International Register of Drug Information Services promotion of safe, effective, rational and economic use2Drug Information ServicesThe centre provides in-depth, unbiased source of of drugs by the health professionals and patients.crucial drug information to meet the needs of the Structure of Drug Information Centrepracticing physicians, pharmacists and other health Framework of drug information centre is a crucial taskcare professionals in following areas:which will determine the efficacy of work & service.Adverse Drug Reactions - Suspected adverse drug 3Setup & Equipmentreactions are assessed. Specific information regardingThe centre should equipped with computer terminalspredisposing factors, relationship to dose or duration oftherapy, incidence, clinical manifestations, and with printer & printed material (current periodical,management are provided.bound journal volume, references texts) and hasEvaluation of Drug Reactions - The significance of aaccess to Medline, the internet and various otherdrug-drug, drug-food, drug-disease or drug laboratorytest interaction is evaluated. The data of drug-drug, drugonlinedrug and medical references.food and drug-disease obtained from the hospitals and The centre should maintain subscription to nationallymedical institutes.recognized journal and text of Pharmacy and Medline.Foreign Drug Identification - The DIC attempts to Centre should have direct access to computerized onidentify drugs in other countries. When possible the DICprovides product composition and US equivalent. Anline data searching CD ROM database and access toassessment of the efficacy and potential hazards of theproduct are also given. Data for foreign can be obtainedthe world wide web (www) should beavailable.(Table1)Table 1 The Framework of Drug Information Centre 1Books, JournalsFormulariesComputer DatabaseDrug Information ServiceWorld Wide Web(www)Poison CentreAccessCallersPhysiciansPharmacistsNursesResearchersStudentsPharmacy & therapeutic CommunitiesLegal aidsDr ug industriesMarketing firmDisseminationInformationReprintAnswer to telephone callComputer retrieval systemInternet SearchPublication & EducationDrug Policy & DecisionCost Benefits AnalysisSharing & Debating on InformationInformation to Patients22

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Staff, Student & Scheduling530(1997) (mean 654.0, range 531-773), respectively.DIC requires one full time director, one full time resident In august 1997, the Karnataka state pharmacy counciland six pharmacy students.established its drug information centre. The centreThe state pharmacy council (Department of Pharmacy) received 1002 calls for the period from august 1997 toprovides the secretarial support. This centre also servesJuly 2000. the queries from doctors were only 132as training site for undergraduate & post graduate student(13.2%). rest the all queries were from patients,of pharmacy.1,3,6pharmacists and drug regulatory authorities. after theEvaluation of the performance of DICThe evaluation of the drug centre at university of awareness program the total numbers of queries receivedKentucky medical center revealed that there was a steady fro the period of August 2000 to January 2002 was 1592increase number of call from the year of 1994 to 1997. and 658 (41.3) were from doctors. Rest 59% of theThe average and range of calls per month form January enquiries was from patient, pharmacist and drug1994 to December 1997 also documented a steady regulatory authorities. The majorities of queries (75%)increase form>350 (1994) (mean 421.7, range 351-548) were received from Bangalore. Response time wasto >400(1995) (mean 467.4, range 416-604) to recorded and about 80% of enquiries were answered>520(1996) (mean 608.3, range 523-704) and to > within 30 minutes.Table 2. List of the Indian Drug Centre & Clinical Pharmacy Department. 2Independent drug information centreCDMU Documentation Centre,CalcuttaDrug information centre, MaharashtraState Pharmacy council, MaharashtraAndra Pradesh State PharmacyCouncil, Andra PradeshKarnataka State Pharmacy Council,KarnatakaJSS, OotyTamilnadu Pharma Information Centre,ChennaiHospital attached drug information centre with clinicalpharmacy serviceChristian Medical College Hospital, Vellore TalimnaduDrug information centre(KSPC), Bowring & Lady CurzonHospital, Bangalore, KarnatakaDepartment of Pharmacy Practice, Chidambaram, TamilnaduDepartment of Pharmacy Practice, National Institute ofPharmaceutical Education & Research (NIPER), ChandigharJawaharlal Nehru Medical Hospital, Belguam, KarnatakaJSS, Mysore, KarnatakaJSS, Ooty, TamilnaduN.R.S Medical Hospital, CalcuttaKempagowda Institute Medical Sciences (KIMS), BangaloreKarnatakaKasturba medical college, Manipal, KarnatakaPoison Information Centre, AIIMS, DelhiPoison Information Centre, National Institute ofOccupational Health, AhemdabadDepartment of toxicology, Amrita Institute Medical Science& Research, CochinToxicology & IMCU Unit, Government General Hospital,ChennaiSri Ramachandra hospital, Porur, ChennaiSri Ramachandra Mission Hospital, Coimbotore, TamilnaduTrivandrum medical college, Trivandrum, Kerela23

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table 3. State-wise List of Contact Address of Drug Information Centres24

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Figure 1 Network of Drug Information Centre (DIC) in IndiaAhemdabadOne HospitalAttached DICAndhra PradeshOne Independent DICCochinOne HospitalAttached DICKerelaOne IndependentMaharashtraOne independentDICDrugInformationCentreDelhiTwo HospitalAttached DICKarnatakaOne Independent &Five HospitalAttached DICPunjabOne Independent &One HospitalAttached DICWest BengalOne Independent &one HospitalAttached DICTamilnaduOne Independent& Five HospitalAttached DICNew Selected Centre inHaryana, Chhattisgarh,Jaipur, Goa & Assam1,3,6Evaluation of the performance of DICThe evaluation of the drug centre at university of In august 1997, the Karnataka state pharmacy councilKentucky medical center revealed that there was a steady established its drug information centre. The centreincrease number of call from the year of 1994 to 1997. received 1002 calls for the period from august 1997 toThe average and range of calls per month form January July 2000. the queries from doctors were only 1321994 to December 1997 also documented a steady (13.2%). rest the all queries were from patients,increase form>350 (1994) (mean 421.7, range 351-548) pharmacists and drug regulatory authorities. after theto >400(1995) (mean 467.4, range 416-604) to awareness program the total numbers of queries received>520(1996) (mean 608.3, range 523-704) and to > fro the period of August 2000 to January 2002 was 1592530(1997) (mean 654.0, range 531-773), respectively. and 658 (41.3) were from doctors. Rest 59% of the25

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Figure 2. Statistical Evaluation Data of DIC in KarnatakaStatistic data of DICNumber of calls1800160014001200100080060040020001997-2000 2000-2002YearSeries1enquiries was from patient, pharmacist and drug very important for drug information centre to frameregulatory authorities. The majorities of queries (75%) guidelines on ethical issues.were received from Bangalore. Response time was Quality of informationrecorded and about 80% of enquiries were answered Providing quality information is one of the crucial task ofwithin 30 minutes.DIC. In order to maintain the flow of quality informationCompetency of Drug Information Centrethe staff should be well trained & comprehensive aboutCompetent evaluation of drug information service andthe quality framework provided by DIC is very the new trends in drug discoveries. It is also highlightedimportant. The development of DIC is the beginning of that information is not knowledge and knowledge comesthe clinical pharmacy concept to provide adequate7from the interpretation of information .information for those who consume, prescribe, dispense Conclusion& administer drug. Factors like information technology Drug Information Centres are regarded as a gateway ofchanges, sophistication of drug therapy, changing drug information. The future of drug information centresphilosophies of pharmacy practices, the education of in India lies in the quality of service, credibility amongpharmacist in the field of drug information and the moreusers and the evaluation of its progress. The future ofknowledgeable patient are very influential in theclinical pharmacy and drug information centre is veryevolution of pharmacist's role in drug informationbright so the government, private hospitals andprovider. To maintain the competency in DIC time totime assessment program is mandatory.regulatory bodies should come forward to establish moreEthical Facetnumber of DIC in future time so that clinical pharmacistAt present, drug information centres are confronted with and drug information centre can work to locate thequestions from public that pose ethical dilemmas. Thequality in community.truthful answer to drug information question mayAcknowledgementcompete with values such as privacy, interference in the The author is thankful to Karnataka State Pharmacypatient-physician relationship and social respons-Council (KSPC), Karnataka, Dr. B Gopalakrishna,4ibilities .New drug like sildenafil used in male erectilePrincipal, R R College of Pharmacy, Bangalore fordysfunction may cause social problem such as abuse by providing useful Information. The author also owe to thehealthy men and indiscriminate prescription by the PKM Educational Trust Management for providingprimary care physician s.For ethical aspect it becomes excellent facility.26

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009References1. Pradhan SC. The Performance of drug information 1990;47:2245-50.centre at the university of Kansas medical center,5. Vernon GM, Woods DJ. Development of anKansas city, USA-Experiences and Evaluation. Ind JPharmacol 2002;34:123-129.International Network of drug Information Center2. Karnataka state pharmacy council. Available from (indices). Aust J Hosp Pharm 1998;28:115-6URL:www.kspcdic.com 6. Lakshmi PK, Gundu Rao DA, Gore SB, Shyamala3. Rajesh DH, Kudagi BL, kamadod MA, S S Biradara. Bhaskaran. Drug information service to doctors ofDrug information Center-Is the window that lets usKarnataka, India. Ind J Pharmacol 2003;35:245-247see the world. The Pharma Review April 2008.4. Kelly WN, Krause EC, Krowiniski WJ, Small TR,7. Malone PM, Mosdell KW, Kier KL, Stanovich JE.Drana JF. National survey of ethical issues presented Drug information: A guide for pharmacists.to drug information centre. Am J Hosp Pharm Stamford ct: Appleton & Lange; 1996.27

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIijoppA prospective study comparing Total Lymphocyte Count (TLC) andCD4 counts in HIV patients in a resource limited setting in India1 2 3 4Lincy Lal , Cijo George , Anitha Yesoda , Jayakumar.B1. Pharmcoeconomic Research Specialist, Drug Use Policy and Pharmacoeconomics, UT MD Anderson CancerCenter, 1515 Holcombe Blvd, Unit 706, Houston, Texas 770302. Manager-Clinical Pharmacy, HCG Towers, P.Kalinga Rao Road, Bangalore-27, Karnataka, India3. Asso. Professor, College of Pharmaceutical sciences, Medical college, Thiruvananthapuram, Kerala, India4. Prof & Head, Dept. Of Medicine, Medical college Hospital, Thiruvananthapuram, Kerala, India*Address for correspondence: llal@mdanderson.orgINTRODUCTIONEven after 25 years of the first detection of Acquired goals of HAART are given in table 1.Immunodeficiency Syndrome (AIDS), it remains a major Various guidelines have been published on HAART to1health care problem without any cure. Extensive make sure that the therapy is appropriate. Theseresearch around the world and the subsequent guidelines give clear information on indications to start4, 5introduction of highly active antiretroviral therapy HAART(HAART) has produced dramatic reduction on Test for CD4 count is too costly for resource poormorbidity, mortality and health care utilization. HAART countries. As highly active antiretroviral therapyregimens have revolutionized the treatment of human (HAART) is now becoming available to largeimmunodeficiency virus (HIV), which consistently populations of HIV-infected patients in resource-poorresults in sustained suppression of HIV-1 RNA countries, resource-appropriate markers need to bereplication, resulting in gradual increases in CD4 T- identified for clinicians to use in deciding when to initiatelymphocyte count, sometimes to normal levels. Durable HAART. Also, monitoring individuals with HIVsuppression of viral replication and the accompanying infection/AIDS involves the use of expensive tools,increases in CD4 count, reverse HIV disease progression, including CD4, which are not readily available ineven in persons with advanced HIV infection.resource- limited settings. Previous studies suggested theDespite these great advancements, HAART poses a absolute lymphocyte count (ALC) or total lymphocytenumber of challenges. Many of the effective regimens are count (TLC, i.e. ALC plus all large lymphocytes such ascomplex and have major adverse effects leading to lymphoblast or reactive lymphocytes) might be useful inproblems with patient compliance and drug resistance. identifying patients who would benefit from initiatingThese problems continue to limit the effectiveness of prophylaxis for AIDS-related opportunistic infections.HAART and present major challenges in managing HIV6,7,8Due to the lack of enough financial as well as qualifiedinfection. Further, cost and intellectual property personnel support, initiation and monitoring of HAARTprotections effectively limit access to antiretroviral drugs based on CD4count becomes a significant challenge in2 TMin countries most heavily affected by HIV. Atripla , India. Patients may have to wait for more than two(efavirenz 600mg, emtricitabine 200mg, tenofovir months to get the CD4 count results even in Nationaldisoproxil 245 mg) a fixed dose, once a day tablet for AIDS Control Organization (NACO) supported centers.treating HIV-1 infection in adults is a promising step to This is a major obstacle in the proper management of3improve patient compliance.HAART in a country like India where the HIV estimateA HAART regimen should be able to delay disease for the year 2005 is 5.21 million infections and it isprogression, prolong survival and maintain quality of life growing at a rapid scale. 9through maximal viral suppression. Considering the Initiation and monitoring of HAART based on TLCconditions and challenges of a resource poor country, the instead of CD4 count is particularly significant in adeveloping country like India. In India the cost of CD4count by flow cytometry is approximately1500 IndianIndian Journal of Pharmacy PracticeReceived on 09/09/2008 Modified on 19/09/2008Accepted on 23/09/2008 © APTI All rights reservedRupees (INR) ($30.00 US) while the cost for TLC is lessthan 40 INR (

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009per capita income is 34,825 Indian Rupees ($820.00 National AIDS Control Organization (NACO) of India10,11US) and the per capita expenditure for health by and subsequently, NACO is funded by various programs12government is about $27.00 US , this cost difference has under WHO. All patients attending ART clinic getsa significant impact in treating AIDS patients.treatment and related tests including CD4 count test freeWHO recommends CD4 count to monitor the patient's of cost.clinical status in AIDS cases; but in resource limited Study data was collected from patients who satisfied thesetting where there is no data on CD4 is available, TLC inclusion and exclusion criteria and gave consent for thecan be used as a substitute for symptomatic patients. study. The inclusion criteria consisted of patients whoAccording to the guideline by WHO for scaling up are 18-65 years of age and patients who are receivingantiretroviral therapy in 2003, CD4 testing is the tool for triple regimen of HAART from the clinic during themaking decision on HAART therapy and monitoring; study period. Exclusion criteria were pediatric patientshowever if this is not available, one can use TLC count less than 18years of age and pregnant patients. Perm-3less than 1200 /mm as surrogate marker for CD4 count ission to conduct the study in the ART unit was given by3 13less than 200 cells/mm .the Head of the Department of Medicine. The study wasThis recommendation was based on rigorous evaluation approved by the Human Ethical Committee ofof data obtained almost exclusively from developed Government Medical College, Thiruvananthapuram. An6, 7,8,14countries.informed consent form, approved by the Human EthicalHowever, there are also studies indicating that Committee, was signed by all patients and this processsubstitution of TLC for CD4 count monitoring might not was in accordance with Good Clinical Practice (GCP).be a good clinical decision. A study conducted in Nigeria The following demographics of the study patients wereevaluating the reliability of total lymphocyte count as a collected: HAART regimen, age, sex, urban/rural, placesubstitute for CD4 cell count found that total lymphocyte and source of infection, disability status, employmentcount is not suitable for CD4 cell count in a resource status, marital status, and income. CD4 count waslimited setting. The sensitivity of total lymphocyte count recorded from the report from the department ofas a predictor of CD4 cell count was 45.5% and the dermatology (CD4 count was ordered from thisspecificity was 62.2%. The study's author concluded that department). WBC and Total lymphocyte count were3if WHO recommendation of 1200 cells/ mm were used to obtained from medical laboratory report. (Both CD4determine treatment, 1 in 3 individuals would have been count and TLC count were done on same day).deprived of needed treatment. So in that particular setting Statistical analysisTLC is not a reliable predictor of CD4 cell count in Sensitivity, specificity, positive predictive value (PPV),HIV-infected individuals. 14 and negative predictive value (NPV) were calculated toBased on these differing evidence accounts, this study's establish the relationship between TLC and CD4 counts.primary aim was to analyze the reliability and clinical A receiver operator characteristic (ROC) curve was alsoutility of total lymphocyte count as a surrogate marker for drawn to determine the best cut-off points. StatisticalCD4 count and to check the reliability of WHO significance was calculated utilizing linear regression.recommendation in resource limited setting in India. The Paired t-test was utilized to determine statisticalmain objective was to calculate the sensitivity and significance of pre and post treatment CD4 counts. Forspecificity values of using total lymphocyte count as a all tests, p

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009patients taking ART enrolled for the study was 142. The that this was a significant difference at p

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Though these methods are under intensive research, we analyzed various combinations of pairedWHO recognizes the immediate need for a low cost observations of CD4 count and TLC. Based on themethod for scaling up of antiretroviral therapy in clinical utility and best descriptive analysis value wecountries where spreading rate of HIV infection is came to the most suitable CD4 count TLC combination.startling. Monitoring of HAART is a must to minimize The best estimate appears to be that if the TLC count isthe more dangerous possibility of developing drug3 3= 3000cells/mm , the CD4 count will be = 400cells/mmresistant which may cause a catastrophe to the already which is also seen in the ROC curve. Though theless than optimal HAART program in developing and3combination of CD4 count = 200cells/mm & TLC count17,18poor countries.3=2500cells/mm is most clinically relevant in the view ofThis study was conducted in the ART unit (in the WHO recommendation, it lacks reasonable sensitivityDepartment of Medicine) of Government Medical and specificity (56.7 & 76.7 respectively).College Hospital, Thiruvanathapuram, Kerala, India. In this study we had 39 patients with CD4 count less thanThis hospital is funded by NACO in support of WHO.3200cells/mm . When the TLC was compared (thoseEven in such a center CD4 testing is irregular for the3having 1500 cells/mm or less and more than 1500 cells/3patients. Because of the high patient load they may have mm ,close to the WHO recommendation.) only 6 patientsto wait up to 3 months to get their CD4 count done. This3had less than 1500 cells/mm TLC count. Though WHOshows the importance of a reliable surrogate marker for3recommends TLC less than 1200 cells/mm can be usedCD4 count for the better administration of HAART. This3as a predictive for CD4 count less than 200 cells/mm , instudy was designed to check the reliability and clinical this study population, it does not seem to be predictive.utility of TLC as a surrogate marker for CD4 count. Had the WHO recommendation followed, only 15.4% ofAlong with this we also compared out results with WHO patients would have got treated and the rest 84.6% ofrecommendation.patients were left untreated. This result could be due toIn this study, from 68 patients we collected 69 paired the small sample size of the study. But the positiveobservations of CD4 counts and TLC. From this data we correlation of CD4 count with TLC promises furtherfind out the direction of change of TLC count with investigation for appropriate levels of TLC which wouldincrease in CD4 count is positive. In addition to predict more precisely the CD4 level less thancorrelating direction of change between TLC and CD43200 cells/mm . Further more this study was conducted forcount, this study also examined the average change in 6 months which is not enough to recruit more number ofTLC per unit change in CD4 count. In this study patients for the study. Total number of pairedpopulation, the average individual specific mean change observations of CD4 count and TLC in this study is 69,3 3in TLC per 1 CD4 cell/mm was 4.6 cells/mm . a nd on ly 26 pati en ts h ad a pre and post treatment CD4To find out the best sensitivity and specificity correlation count.Table – 1: Goals of HAART 4 *Goals of HAART 4Maximal and durable suppression of viral r eplication (measured by viral load assays)Restor ation and/or preservation of immune functionReduced human immunodeficiency virus (HIV)-related morbidity and mortalityImproved quality of lifeLimit the likelihood of viral resistance to preserve future treatment optionsProvide maximum access to HAART regimens31

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table –2: Study Population DemographicsFigure 1: Linear Regression of Lymphocytes versus CD4 counts (p

Indian J. Pharm. Pract. 1(2), Jan-Mar, 200933

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Figure 2: Receiver Operator Curve (ROC) for CD4 ValuesReceiver Operator Curve (ROC) for CD4 Values1Sensitivity0.80.60.40.2CD4= 400CD4= 350CD4= 300CD4= 250CD4= 20000 0.1 0.2 0.3 0.4 0.51- SpecificityReferences1. Fletcher V, Kakuda NK, Collier AC. Human Mehta K, Solomon S. et.al. Changes in Totalimmunodeficiency virus infection. In: Dipiro TJ, Lymphocyte Count (TLC) as a surrogate for changesTallbert LR , Yee CG, Matzke RG, Wells GB, Poseyin CD4 count following initiation of HAART:LM, editors. Pharmacotherapy: A Pathophysiolo-Implications for monitoring in resource – limitedthgical approach. 5 ed. United States of America:settings. J Acquir Immune Defic Syndr 2004; 36:McGraw-Hill Medical publishing division; 2002:567-575.2151-2174.2. Kojic EM, Carpenter CJ. Initiating antiretroviral9. National AIDS control organization (India)therapy. Available from University of California, HIV/AIDS epidemiological surveillance &San Francisco, CA, (US); hivinsite; 2006.estimation report. New Delhi:20053. U.S Food and drug administration (US).FDA 10. World Bank (US).World development indicators,approves the First Once-a-Day Three-Drug India- data and statistics. Washington: DataCombination Tablet for Treatment of HIV-1. Silver profile; 2008Spring: FDA news;2006.11. Reserve bank of India (India).RBI reference rate on4. New York State Department of health (US). Anti-31/07/08.Mumbai:Exchange rate; 2008retroviral therapy. New York :2008.12. World heath organization (Switzerland).Selected5. Guidelines for the Use of Antiretroviral Agents innational health accounts indicators. Geneva: TheHIV-1-Infected Adults and Adolescents. NationalInstitute of Health, Maryland, (US); aidsinfo; world health report; 2006.October 10, 2006.13. World heath organization (Switzerland).Scaling up6. Jacobson MA, Liu L, Bashi HK , Deeks S, Hecht of Antiretroviral Therapy in resource limited setting.FM, Kahn J. Absolute or total lymphocyte count as a Geneva: Guidelines for a public healthmarker for the CD4 T lymphocyte criterion for approach;2002initiating antiretroviral therapy. AIDS 2003;17: 917- 14. Akinola N O, Olasode O, Adediran I. A, Onayemi O,919. Murainah A, Irinoye O. et.al. The Search for a7. Spacek LA, Griswold M, Quinn TC, Moore RD.Predictor of CD4 Cell Count Continues: TotalTotal lymphocyte count and hemoglobin combinedLymphocyte Count Is Not a Substitute for CD4 Cellin an algorithm to initiate the use of highly activeantiretroviral therapy in resource-limited settings.Count in the Management of HIV-InfectedAIDS 2003; 17:1311–1317.Individuals in a Resource-Limited Setting. Clin8. Mahajan AP, Hogan JW, Snyder B, Kumarasamy N, Infec Diseases. 2004; 39:579–581.34

Indian J. Pharm. Pract. 1(2), Jan-Mar, 200915. Farmer P, Léandre F, Mukherjee JS, Claude M, Nevil 2002;34:984-990.P, Smith-Fawzi MC. et.al. Community-based 17.Harries AD, Nyangulu DS, Hargreaves NJ, Kaluwaapproaches to HIV treatment in resource–poor O, Salaniponi FM. Preventing antiretroviral anarchysetting. Lancet 2001;358:404-409in Sub-Saharan Africa. Lancet 2001; 358:410-414.16. Mitty JA, Stone VE, Sands M, Macalino G, Flanigan18. Weidle PJ, Mastro TD, Grant AD, Nkengasong J,T. Directly observed therapy for the treatment ofpeople with human immunodeficiency virus Macharia D. HIV/AIDS treatment and HIV vaccinesinfection: a work in progress. Clin infec diseases for AFRICA. Lancet 2002; 359: 2261-67.35

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIijoppA Study of Clinical Pharmacist Initiated Changes in Drug Therapyin a Teaching HospitalBhupathy Alagiriswami, *Madhan Ramesh, Gurumurthy Parthasarathi and Hatthur BasavanagowdappaDepartment of Pharmacy Practice, JSS College of Pharmacy, Mysore -151Professor and Head, Department of Medicine, JSS Medical College Hospital, Mysore - 15Address for correspondence: madhanramesh@hotmail.comAbstractThis study was aimed to assess and quantify the pharmacist-initiated changes in drug therapy and its cost savings ata tertiary care South Indian Hospital. The medication details of all patients enrolled to the study was collectedprospectively and reviewed independently by the intervening pharmacist to identify any Drug Related Problems(DRPs). Where an DRP was identified, it was discussed with physician and suitable suggestion was provided.Clinical significance of each intervention was graded based on the expected clinical outcome. An independent panelconsisting of clinician and academic clinical pharmacists reviewed all the interventions made by the interveningpharmacist for potential cost savings relating to length of stay, readmission, drugs, medical procedures andlaboratory monitoring. A total of 261 DRPs were identified from 189 patients. The incidence of DRPs was found to be7.9 per 100 patients. The most common DRP was found to be drug use without indication (18%) followed by improperdrug selection (14%). Seventeen percent of the DRPs observed were in patients suffering from cardiovasculardisorders followed by respiratory disorders (15%). The average time spent for each intervention was 12.5 minutes.The most frequent change initiated by the intervening pharmacist was cessation of the drug (20%). The annualizedcost savings incurred by the pharmacist-initiated changes in drug therapy was Rs: 46,686 /=.In our study, pharmacist initiated change in drug therapy was well accepted by the physicians. The studydemonstrates that routine clinical pharmacist review of in-patient drug therapy can improve patient outcome andreduce patients' healthcare cost.Key words: Pharmacist, Intervention, Drug therapy, Drug related problems, Cost.INTRODUCTIONDrug therapy enhances health related quality of life4,5likelihood of similar events occurring in the future . In1(QoL) for most of the diseases . Despite excellent clinical medicine, a wide range of drug related problemsbenefits and safety profile of most medications, drug3,6might arise due to various causes. Various factorsrelated problems pose a significant risk to patients, which encountered in medical practice lead to DRPs. Medicaladversely affect quality of life, increases hospitalization prescribing errors, improper dosage, improper drug2,3and overall healthcare costs. However, optimization of selection, drug-drug interaction, drug without indication,drug therapy may, by preventing Drug Related Problems untreated indication are the most commonly encountered(DRPs), influence health expenses, potentially save lives6DRPs. The cause of DRPs also includes those that are1, 2, 3and enhance patient's quality of life. Increased use of iatrogenic and idiosyncratic in nature. In addition, factorsmedication and availability of new drug therapies like increased use of medications, polypharmacy andpotentially increase the risks of patient for iatrogenicavailability of new drug therapies will potentially3, 64,5adverse drug events in hospitals. Iatrogenic adverseincrease the risk of drug-induced illness.Studies on the prevalence of DRPs in hospitals and aevents are important for consideration because it can notcloser characterization of all DRPs are lacking and theonly prolong hospital stay but also increase the patientbedside clinical approach evaluation of patients' DRPs ishealthcare expenditure. Therefore, it is important that all 1applied. However, studies carried out to assess anddrug related problems resulting in serious injury or death 6minimize DRPs in hospitals are reported. It is reportedare evaluated to assess whether improvement in thethat medication errors occur in 3-6.9 % of in-patients andhealthcare delivery system can be made to reduce thethe error rate for in-patients' medication orders wasreported to be 0.03-16.9 % with each hospitalIndian Journal of Pharmacy PracticeReceived on 24/10/2008 Modified on 17/02/2009Accepted on 19/02/2009 © APTI All rights reserved7experienced a medication error every 22.7 hours. AnIndian study reported that the incidence of DRPs was136

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009found to be greater than quoted as an average in in our study. The exclusion criterion was patients3developed countries . High incidence of inappropriate receiving treatments on out-patient basis. Thedosage and improper drug selection observed in the study intervening pharmacist was a postgraduate pharmacywas attributed to lack of standard treatment protocols or a practice student. All the interventions made by theformulary for hospital and the differing treatment intervening pharmacist were preceded by consultationpatterns between the medical wards in each Indian with the academic clinical pharmacist. The medication3hospital .details of all those patients who were admitted to medicalDrug therapy has become so difficult that no one wards were collected and documented in a suitablyprofessional is expected to optimize the drug therapy and designed data collection form. The intervening7,8control DRPs alone . Today there exist a due problem in pharmacist, to identify the drug related problems,medical care that urgently requires expert attention reviewed collected data independently. Nature of thenamely that of preventable drug related morbidity and drug related problem of each case that was identified was3,9mortality . These problems could be well preventable / categorized based on categories described by Helper andminimized by initiating changes in drug therapy through9Strand.3clinical pharmacy services . Also, reduction in healthcare Drug related problem identified was brought to the noticecost and improved patient care may be attained through of the concerned physician for the remedial action andclinical pharmacy services by ensuring the rational use of the primary reason(s) for initiating the intervention wasmedications, and improving patient compliance with recorded. In addition, appropriate suggestions were10medications .provided to the concerned physician at the earliestA study in the United States estimated that the cost of possible time. The clinical significance of eachtreating conditions caused by inappropriate medication intervention was assessed by the intervening pharmacist,8was US $177.4 billion in 2000. It is reported that due to and later reviewed and verified by an academic clinicalhigh expenditure towards medical expense patients tend pharmacy practitioner for accuracy. The acceptance levelto skip the medication or nonadherence to the medication of physician for the particular intervention was alsothat will worsen the disease condition. Pharmacist can recorded as either accepted or not accepted. Similarly,ensure appropriate drug use, decrease out of pocket whether or not there was a change in drug therapy was11expenditures, and improves access to needed drugs by noted. After the interventions, further details such asproviding consultation at the point of care. In a recent suggestions provided, its category and resources orstudy it is reported that the annualized cost savings references consulted were documented. In addition, therelating to length of stay, readmission, drugs, medical total time taken by the intervening pharmacist inprocedures and laboratory monitoring as a result of preparing and undertaking the intervention was recorded.clinical pharmacist initiated changes to hospitalized At the time of patient discharge, the interveningpatient management or therapy was $ 4 444 794 for eight pharmacist documented the actual changes to drugmajor acute care government funded teaching hospitals therapy and patients' outcomes relating to the2in Australia. Studies exploring cost savings achieved intervention. The involvement of pharmacist inthrough the provision of clinical pharmacy services to therapeutic decision - making was rated according tohospitalized patients in major acute care teaching Campagna's decision- making model, but forhospital are limited. Moreover, in Indian setup, studies simplification.assessing the pharmacist interventions and its cost savingAn independent clinical panel was convened whichhas not been well demonstrated. Hence, this study wasconsisted of a consultant physician, final yearintended to assess and quantify the clinical pharmacistpharmacist.All those interventions, which were acceptedpostgraduate medical student and an academic clinicalinitiated changes to drug therapy and its cost savings atJSS Medical College Hospital, Mysore.and changed by the physician, were assessed by the panelMETHODSfor any possible impact on the following: length of stayThis prospective study was conducted at a 1000 bed (LOS), readmission probability, medical procedures andmultispeciality tertiary care teaching hospital (JSS laboratory monitoring. The independent clinical panelMedical College Hospital, Mysore) over a period of reviewed only those interventions perceived by theseven months. In-patients of either sex of any age intervening pharmacist as having an impact on eitherundergoing treatment in medicine wards were included length of stay, readmission probability, medical37

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009procedures or laboratory monitoring. The panel then mentioned in Indian Drug Review (IDR) was considered.confirmed or rejected the intervening pharmacist's All those changes made in drug therapy were noted fromassessment and quantified the resultant changes. The patients' medication administration records. The totalcriteria for assessment and quantification of these drug cost was calculated by considering only the actualchanges were based solely on review of the individual drug cost based on drug, dose administered, frequencycase and the collective decision of the panel. The panel and duration of therapy. Administration charges, syringesdid not assess the interventions perceived to result only in and reconstitution solutions, and discharge medicationsa change in drugs but instead intervening pharmacist were excluded from the cost assessment procedure. Costcalculated the impact on drugs-costs. Actual cost at the of injections was calculated as whole vials. If a dosestudy site was considered for the purpose of analysis of range was prescribed, cost was based on the average doseimpact on cost savings on length of stay, probability of2administered.readmission and evaluation of changes to lab monitoring. Annualized Cost SavingsCost Evaluation of Probability of Readmission and Annualized cost savings were calculated byLength of stayextrapolating the seven months' data and their associatedThe probabilities of readmission were estimated based cost saving over a year.on the probability (expressed as percentage likelihood) RESULTSof a readmission event occurring without the interventionA total of 3315 cases were followed and reviewed in thecompared with the probability of a readmission after themedical ward over seven months period. Of the cases2reviewed, 261 drug related problems were identifiedintervention has occurred. Costs were then calculated bymultiplying this probability with the average cost of the from 189 patients. The incidence of DRPs was found totreatment for specific disease costing at study site.be 7.9 per 100 patients followed. Average DRPs perThe panel quantified the impact of each intervention on prescription was 1.4 (range: 1 to 5). Majority [57.8 %LOS by estimating the change in the number of days in (n=109)] of patients were male. The average age of theeither a general medical ward or high dependency wards patients was 49.8 + 13 (Mean +SD) years (range: 19 to 80(Incentive Care Unit, Coronary care unit, Emergency years). Majority (52.8%) of DRPs occurred in the agewards). The change in LOS was based on likelihood of group of 41- 60 years. The demographic details of thechanges in LOS occurring if the intervention was not study patients are summarized in Table 1.2done. The local independent clinical panel decided as to The most common drug related problem was drug usesub-classification of the wards based on individual case. without indication, which accounted for 18% (n=47) ofThe cost impact of changes in LOS was then calculated total DRPs followed by improper drug selection [14%based on average ward costs for the particular ward as (n=36)] and subtherapeutic dose [14% (n=36)].The typesexisted at the study site.of drug related problems are summarized in Table 2.Laboratory Monitoring Changes and Medical Of the total interventions, the significance levelProcedures'moderate' was found to be high (60%) followed byThe independent clinical panel examined the changes to significance level 'minor' (29%). The significance levellaboratory monitoring or medical procedures and of drug related problems is represented in Table 3.allocated a probability of the event being changed as a The most frequent suggestion provided by theresult of the intervention. The cost impact was then intervening pharmacist was cessation of drug [20 %calculated by multiplying this probability by the study (n=53)] followed by addition of drug [14% (n=37)].site's costs for the particular medical procedure or Change in drug dose accounted for 13% (n=33) of totallaboratory test.suggestions provided. Suggestion related toEvaluation of Drug Costpharmaceutical aid was found to be least [2% (n=4)].The impact of pharmacist intervention on drug cost was Various suggestions provided by the interveningassessed by considering change in the medication orders pharmacist are summarized in Table 4.that occurred during hospital stay. The discharge The acceptance rate of intervening pharmacist'smedications of the patient were not considered for cost suggestions was found to be 87 % (n=227). Of these,2evaluation. For the analysis of drug costs, intervening changes in drug therapy was observed in 81% (n=183) ofpharmacist referred latest issue of Current Index of accepted suggestions. The total time spent by theMedical Specialities (CIMS). If the drug costs for the intervening pharmacist in preparing, undertaking andparticular drug was not available in CIMS, then cost documenting all interventions was 106 and 25 minutes38

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009[average 12.5 minutes; range: 2 to 60 minutes].gastritis associated with use of antibiotics and NSAIDs.Of the total interventions, 46% (n=118) of interventions However, where appropriate, after interveningbelonged to drug therapy decision-making level 1 pharmacist's intervention rabeprazole was withdrawn(Corrective) followed by level 4 (Proactive) accounting from the patient's therapy.to 30% (n=79). The Pharmacist's involvement in drug Improper drug selection [14%] was the second mosttherapy decision making is presented in Table 5.common DRP observed. This finding coincides with theA total of 128 interventions resulted in decrease in cost of3study conducted by Gurumurthy Parthasarthi et altherapy while 33 interventions incurred additional cost. wherein, it reported improper drug selection [17%] as theThe total net cost savings was Indian Rupees (INR) second most common DRP that occurs in medicine27,233.55/=. This included savings of INR 5590.50/= forwards. The high incidence of improper drug selectionreduction in length of stay, INR 9079.85/= formay be attributed to lack of standard treatment protocolreadmission reduction, INR 476.20/= for laboratoryin the hospital, poor history taking etc. In one incidence,monitoring and INR 12,087.00/= for drugs. The impacthypertensive patient with a history of diabetes wasof pharmacist-initiated changes to drug therapy and theiradministrated with Beta-blocker owing to lack ofassociated cost savings is presented in Table 6.documentation of patient's medical history. Later, whenDISCUSSIONIn India, clinical pharmacy service is an emergingintervening pharmacist reviewed the case, it was3discipline . Clinical pharmacy service is to optimizeobserved that the patient was also diabetic andpatient outcomes by working to achieve the bestappropriate intervention was made as beta blockers may12possiblequality use of medicines. It has been shown thatmask the hypoglycemic side effect of anti-diabetics.the clinical pharmacy activities reduce the drug relatedFailure to receive drug was accounted for 5% (n=14) ofproblems related hospitalization, probability of readthetotal DRPs. In few cases, it was due to economic2,3 constraints of the patients that led to non-procurement ofmission and total cost of drug therapy. This prospectiveprescribed medicines while in few other cases it was duestudy was carried out to assess and quantify thepharmacist-initiated changes in drug therapy of intotake the medications for unknown reasons. Other typesto shift change of nursing staff and reluctance of patientspatients of a tertiary care teaching hospital.In our study, DRPs were high (52.8%) in patients aged of DRPs including drug duplication and class duplicationbetween 41and 60 years. Of the 189 patients, DRPs were majority due to availability of more than 80,000commonly observed in male patients (57.8%). This formulations of drugs in Indian market with different3finding might be due to increased medication use owing brand names leading to confusion. This error can beto their multiple co-morbidities. Majority (71.4%) of minimized by prescribing generic names and also bypatients received more than six drugs per day and hence reviewing and re-checking of medication order regularlyincreased risk of occurrence of drug related problems. prior to drug administration.Regular review of patients' medication use may Of the 261 DRPs, 29% (n=75) were rated to be 'minor',potentially decrease the drug related problem. 13 60% (n=157) were 'moderate' and 11% (n=29) wereDrug use without indication [18% (n=47)] was the most 'major' significance of interventions. This findingcommon DRP observed followed by improper drug3correlates with a study that reported 49% ofselection [14% (n=36)]. This observation is in contrast interventions as 'moderate' significance. The 'moderate'with the study carried out by Gurumurthi Parthasarthi et significance level is the level of problems requiring3al , in which inappropriate dosing accounted for highest adjustments, which are expected to enhance(31%) followed by improper drug selection (17%). Few effectiveness of drug therapy producing minor reductiondrugs often used without indication included in patient morbidity or treatment costs. In our study, forRabeprazole, Paracetamol and Ranitidine. Although anti example, patient experienced severe diarrhea [presencesecretory agents often used as prophylaxis, especially in of signs of dehydration with abdominal pain and cramps]patients with previous history of acid peptic ulcer after receiving Clindamycin. After having assessed thedisease, the agents were prescribed while there was no ADR, the intervening pharmacist informed physiciansuch indication. A study conducted by David L. Whaley about the possible Clindamycin induced diarrhoea and14et al reported that gastrointestinal agents were the major sought for the cessation of drug. Thus the timelyclass of drug prescribed in a hospital. In our study, the use intervention by intervening pharmacist might haveof proton pump inhibitor was to prevent the possible resulted in reduction in hospital stay and hence the cost39

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009involved in the management of adverse drug reaction. the suggestions provided. In few cases, experiencedAntibiotics (21%) was the most commonly implicated physician did not change their routine prescribing patterndrug class in DRPs. This observation was coinciding despite the presence of DRP, especially, DRP of 'minor'15,16with observations made by different studies. Ahuva significance. For example, a suggestion for use of15Lusting found antibiotics (38.7%) as the most prevalent domperidone instead of ondansetron for vomiting wasclass of drugs prescribed in hospital. Inappropriaterejected.antibiotic usage may provoke the emergence of bacterial The total time spent by the pharmacist in preparing,resistance and increased healthcare cost. Similar finding undertaking and documenting all interventions was 106was reported in a study conducted by Carlos Bantar ethours and 25 minutes. The average time spent for each16al . In our study, patients were either receiving high doseintervention was 12.5 minutes (range: 2 to 60 minutes).of antibiotics or antibiotics were prescribed without any 2This observation is in contrast to Michael J. Dooley et alvalid indication. Of the 261 DRPs, 17% and 15% of thestudy wherein 9.6 minutes (range: 0-60 minutes) wasDRPs were found in patients treated for cardiovascularspent for each intervention. This difference may bedisorders and respiratory disorders respectively. These2 attributed to the fact that unlike India, drug informationobservations correlated with the Michael J. Dooley et alservices and patient medication history were availablestudy conducted in Australia. In our study, it may be17perhaps due to high occupancy rate of patients withonline in developed countries like Australia . In addition,cardiovascular disorders and respiratory disorder in unlike our study, involvement of experienced clinicalmedical ward resulting in use of more medication in these pharmacist would have led to the high acceptance ratepatients, thus leading to potential DRPs. and also reduction in time spent for each intervention.Cessation of drug (20%) and addition of drug (14%) were Textbooks were found to be the most frequently (56%)the suggestions most frequently provided. This finding consulted references followed by the personal2differs from observation made in an Indian study knowledge of the intervening pharmacist in providingwherein change in drug dose was reported as the most various suggestions. As majority of DRPs were of 'minor'common suggestion made. Other suggestions made in significance, most of DRPs were managed with theour study included change in drug dose, duration of amount of information available in various textbooks.therapy, frequency of administration and substitution of The information available in textbooks is verydrug etc. Addition of drug was suggested in case of comprehensive and also covers wide ranges of diseasesuntreated indications that required treatment. Few of the and their treatment aspect. Also, since the department ofuntreated conditions included anemia, cough and cold. In clinical pharmacy located at JSS hospital is wellmost cases, the change in drug dose was sought inequipped with drug information resources including thepatients with renal/hepatic impairment requiring dosagelatest resources of textbooks, it was possible to obtainreduction. In our study, the major reasons for cessation oflatest information required to address the DRPs.drug were due to drug use without indication andAll the 183 interventions which were accepted andimproper drug selection. Few examples that warrantedchanged by the physicians were allocated for costthe cessation of drugs in our study included use of betaanalysis.Of these, 163 interventions had impact on theblockers in asthma patient, steroids in diabetes andcost and the remaining interventions did not have anyparacetamol in afebrile condition. These findings of ourimpact on cost savings. Of the 163 interventions, 126study indicate that there is a scope for pharmacist tointerventions had impact on drug cost alone and hencesuggest issues related to rational drug therapy andemphasise the importance of involvement of pharmacistonly 37 interventions were assessed by the independentin healthcare delivery.panel for quantification of length of stay, readmission,The acceptance rate of intervening pharmacist's medical procedures and laboratory monitoring. Assuggestions was found to be high (87%). This decided by the clinical panel, 33 interventions had3,10observation correlates with other published studies . Of resulted in cost-savings but two interventions resulted inthe 87% of interventions accepted, 81% of interventions increase in cost of therapy. However, two interventionsled to the changes in drug therapy. The remaining 19% of were excluded as there was no impact on cost savings.interventions that did not lead to changes in drug therapy The net cost savings made through interventions wasmight perhaps be due to lack of information to strengthen Indian Rupees (INR): 27,233/=. In our study, the40

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No.1 - Demographic details of the study patientsCharacteristics Number (%) (n= 189)Age (years) 18-29 10 (5.3)30-40 31(16.4)41-50 50 (26.4)51-60 50 (26.4)61-70 42 (22.2)71-80 6 (3.2)Sex Male 109 (57.8)Female 80 (42.3)Number of drugs receivedper patient1-5 drugs 54 (28.6)6-10 drugs 116 (61.4)>10 drugs 19 (10)Co-morbidities Nil 56 (30)1-2 95 (50)3-4 31 (16)>4 7 (4)Table No.2 - Types of drug related problemsDrug related problemsNumber (%) (n=261)Drug use without indication 47 (18)Improper drug selection 36 (14)Sub therapeutic dose 36 (14)Drug interaction 31 (12)Over dose 28 (11)Adverse drug reaction 21 (8)Untreated indication 19 (7)Failure to receive drug 14 (5)Others* 29 (11)* Class duplication (n=12), Drug duplication (n=9), Dispensing errors (n=6) and Drug usewithout prescription (n=2).41

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No.3 - Significance level of drug related problemsSignificance level*Number (%) (n=261)Minor 75 (29)Moderate 157 (60)Major 29 (11)* Minor: Problems requiring small adjustments and optimization to therapy, which are notexpected to significantly alter hospital stay, resource utilization or clinical outcome.Moderate: Problems requiring adjustments, which are expected to enhance effectiveness ofdrug therapy producing minor reductions in patient morbidity or treatment costs.Major: Problems requiring intervention, expected to prevent or address very serious drugrelated problems, with a minimum estimated effect on reducing hospital stay by no less than24 hours.Table No. 4 - Suggestions provided by the intervening pharmacistSu ggestion provid edN umb er (%)(n =261)Cessation of drug 53 (20)Addit ion of drug 37 (14)Cha nge in drug dos e 33 (13)Cha nge in durat ion of therapy 31 (12)Cha nge in frequency of ad ministration 23 (9)Substit ution of drug 22 (8)Cha nge in cost of therapy 18 (7)Cha nge in route of adm inistration 13 (5)Cha nge in dosage form 12 (5)Pharmaceutica l a id 4 (2)Others * 15 (6)* Need for laboratory investigation (n=1), need for patient counseling (n=6), annotationchanges (n=7) and availability of drugs (n=1).42

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No.5 - Pharmacist’s involvement in drug therapy decision makingD ecision m ak ing lev el* T o ta l (% ) (n= 2 61 )Lev el 1 4 2 (1 6 )Lev el 2 1 1 8 (4 6)Lev el 3 2 2 (8 )Lev el 4 7 9 (3 0 )* Level 1 (Annotative): The pharmacist is clarifying a prescription and/or the interventions of aprescriber. The prescriber makes no changes.* Level 2 (Corrective): The pharmacist is actively questioning a prescription to try to get it changedor corrected. His advice may be accepted or rejected. The prescription may or may not bechanged.* Level 3 (Consultative): The pharmacist is making an active contribution to a discussion. He isasked for or offers his advice before a decision is made. His advice may be accepted or rejected.The prescription may or may not be written or changed.* Level 4 (Proactive): The pharmacist suggests something, which has not been previouslyconsidered. He may also initiate and/ or start a discussion. His advice may be accepted or rejected.The prescription may or may not be written or changed.Table No.6 - The impact of pharmacist initiated changes to drug therapy and their associatedcost savings.Number of interventionCost incurred (INR)Increase inCost ofTherapyDecreasein Cost ofTherapyIncrease inCost ofTherapyDecreasein Cost ofTherapyLength of StayGeneral ward bed 2 12 315.00 3176.05High dependency bed 0 4 0 2729.45Readmission 0 13 0 9079.85Laboratory Monitoring 0 4 0 476.20Medical Procedures 0 0 0 0Drugs 31 95 1621.75 13708.75Total 33 128 1936.75 29170.30Overall Savings (net savings) 27233.55Annualized Savings 46686.0843

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009potential cost savings quantified arose only from the This findings correlates with the multicentre prospectiveintervening pharmacist-initiated interventions. The2study conducted in Australia which showed a reductionpotential cost savings arose from other activities carried of $1 50 307 due to decrease in length of stay as a result ofout by the intervening pharmacist such as drugtheir intervention in eight major acute care hospitals. Theinformation, patient medication counseling, monitoringdifference in the magnitude of reduction in healthcareand managing adverse drug events were not consideredexpenditure due to reduced length of stay may beand quantified. In addition, the total time spent by theexplained by the fact that their study was conducted on aintervening clinical pharmacist to address the DRPs was106 hours and 25 minutes. If the intervening clinical large-scale population in eight acute care governmentpharmacist had spent more time in reviewing patients' funded hospitals.drug therapy, it would have resulted increased potential The potential for probability of readmission wascost savings. Moreover, the cost savings due to prevented in 13 cases and that resulted in cost savings ofintervention quantified in our study were a direct link to INR: 9079.85. This finding differs with the Michael J.utilization of specific health resources. Although some2Dooley et al study wherein the cost saving was found topatients experienced other health outcome benefits from be $111848. There were no interventions on medicalthe interventions done by the intervening clinical procedures that resulted in cost savings and only fourpharmacist, these outcomes were not quantified ininterventions had impact on laboratory monitoring thateconomic terms. Reduction in drug cost accounted forresulted in cost savings amounting to INR: 476.20. Inthe majority of the cost-benefit measured. It is obvious2Michael J. Dooley et al study the expenditure onthat increased number of drug use without indication andimproper drug selection increases the unnecessary druglaboratory monitoring was $ 4558 and cost savings oncost. Therefore, by intervening in these types of DRPs laboratory monitoring was accounted for $ 4 213.clinical pharmacist can contribute to reduction inIn our study, the annualized cost savings due to clinicalunnecessary healthcare expenditure arising due to use of pharmacist-initiated changes to drug therapy was foundunnecessary medications. The total drug cost saved due2to be Rs: 46,686.08. In Michael J. Dooley et al study, theto clinical pharmacist interventions was INR: 13,708.75 reported annualized saving was $ 4 444 794. Thewhile increase in drug cost accounted for Rs: 1621.75. difference in the annualized cost savings between theseThis increased drug cost observed in our study was two studies is due to fact that variation in the studymajority due to untreated indication such as anemia,population and number of hospitals included in the study.cough and vomiting. Although, addition of drug in these 2Michael J. Dooley et al study was conducted at eightcases led to increase in treatment cost, patient would havemajor acute care hospital with well trained andbenefited in terms of therapeutic outcome. However, thenet drug cost savings was INR: 12,087. Savings of drugexperienced pharmacist. But, our study was conduced in2cost was also observed in Michael J. Dooley et al studya single tertiary care teaching hospital and also thewherein the cost savings accounted for $8 279 while the intervening pharmacist was a postgraduate clinicalincreased drug cost accounted for $ 7964. Our study pharmacy student with minimal experience on drugfindings reveal that the clinical pharmacist's intervention therapy reviewing and managing DRPs. Other reasonsis one of the effective cost saving measures, and clinical might be due to differences in the cost of drugs,pharmacists should enforce their attitude towards cost laboratory tests, hospital stay charges etc between theeffective patient management.study sites.Increased length of stay has been consistently associatedNevertheless, clinical pharmacist initiated changes towith drug related problems like inappropriate drugdrug therapy resulted not only the cost savings but alsoselection and subtherapeutic dose. Interventions of theseassociated with improved patient outcome. The overallDRPs would certainly result in reduction in the patients'observation made from this study was that pharmacistshealthcare expenditure. In our study, the reduction oftreatment cost due to reduction in length of stay was have greater responsibility in healthcare team inestimated to be INR: 5905.50 while two of the minimizing and/or preventing drug related problems andinterventions had increased the length of stay thereby thereby can potentially reduce the unnecessary hospitalincreasing the healthcare expenditure by INR: 315.00. stay, readmission, laboratory monitoring and drug cost.44

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009CONCLUSIONOur study demonstrates that the physicians' acceptancerate of pharmacist-initiated changes in drug therapy ishigh. Clinical pharmacist's review of in-patients drugtherapy can positively influence the patient outcomesand reduce healthcare costs. This proves the fact thatclinical pharmacist has an enormous role to play in thehealthcare management through quality use ofmedicines.ACKNOWLEDGEMENTWe would like to thank the Principal, Staff andPostgraduate students of Department of PharmacyPractice, JSS College of Pharmacy, Mysore, and the Staffof Department of Internal Medicine and AdministrativeStaff of JSS Medical College Hospital, Mysore for theirsupport and encouragement.REFERENCES1. Salvesen Blix Hege, Viktil Kirsten K, ReikvamAsmund, Anders Moger Tron, Jahren Hjemaas Bodil,Piia Pretsch et.al. The majority of hospitalized patientshave drug-related problems: results from a prospectivestudy in general hospitals. Eur J Clin Pharmacol 2004;60: 651-658.2. Dooley Michael J, Allen Karen M, DoeckeChristopher J, Galbraith Kirsten J, Taylor George R,9. Helper Charles D, Strand Linda M. Opportunities andresponsibilities in pharmaceutical care. AmericanJournal of Hospital Pharmacy 1990; 47:533-534.10. Olesson Sten, Parthasarathi G. Adverse drugreactions. In: Parthasarathi G, Nyfort-HansenKarin,Nahata Milap C. A textbook of clinical pharmacystpractice. 1 ed. Orient Longman Private Limited;2004: 84-102.11. Stebbins Marilyn R, Kaufman David J, LevensLipton Helene. The price clinic for low-incomeelderly: a managed care model for implementingpharmacist-directed services. Journal of ManagedCare Pharmacy 2005; 11:333-341.12. The Society of Hospital Pharmacist of Australia(SHPA) committee of specialty practice in clinicalpharmacy. Practice Standards: Standards of practicefor clinical pharmacy. The Society of HospitalPharmacist of Australia 1996; 2-16.13. Dell Kale MO, Kuoukarelan Suzan. Impact of theclinical pharmacist on readmission in patients withacute coronary syndrome. The Annals ofPharmacotherapy 2005; 39: 1432-1427.14. Whaley DL, Tomich DJ, Kelly PC, Tanner J,Mahnke CB. Impact of clinical pharmacist-ledguideline enforcement on drug costs, patientsatisfaction. Formulary 1999; 34: 257-268.15. Lusting Ahuva. Medication errors prevention bypharmacist- an Israeli solution. Pharmacy WorldBright Jennifer et.al. A prospective multicentre study Science 2000; 22(1): 21-25.of pharmacist initiated changes to drug therapy and 16. Bantar Carlos, Sartori Beatriz, Vesco Eduardo, Heftpatient management in acute care government funded Claudia, Saul Mariano, Salamone Francisco et.al. Ahospitals. British Journal of Clinical Pharmacology hospital wide intervention program to optimize thequality of antibiotic use: impact on prescribing2004; 57(4): 513-521.practice, antibiotic consumption, cost savings and3. Parthasarathi G, Ramesh M, Kumar JK, Madaki S.bacterial resistance. CID 2003; 37:180-186.Assessment of drug-related problems and clinical17. Caspi Alan, Rozenfeld Vitalina, Kleyman Jennie.pharmacists' interventions in an indian teachingPrevention of medication errors in the hospitalhospital. Journal of Pharmacy practice and Researchsetting: the role of pharmacy students. Pharmacy and2003; 33: 272-274.Therapeutics 2005; 30: 183-186.4. Einarson Thomas R. Drug-related hospital admission.The Annals of Pharmacotherapy 1993; 27: 832-840.5. Roberts Michael S, Stokes Julie A, King Michelle A,Lynne Teresa A, Purdie David M, Glasziou Paul Pet.al. Outcomes of a randomized controlled trial of aclinical pharmacy intervention in 52 nursing homes.British Journal of clinical pharmacology 2000; 51:257-265.6. Strand LM, Morley PC, Cipolle RJ, Ramsey R,Lamsam GD. Drug related problems-their structureand function. The Annals of Pharmacotherapy 1990;24:1093-1097.7. Bond CA, Raehi Cynthia L, Franke Todd. Medicationerrors in united states hospitals. Pharmacotherapy2001; 21(9): 1023-1036.8. Kaleemudin Mohammed, Sankham Rajendran D,Bojaraj Suresh. The role of clinical pharmacist inpoison- related admission in a secondary carehospital. Australian Journal of Pharmacy 2001; 31:26-30.45

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIINTRODUCTIONGrowing expenditure on pharmaceuticals is one of thedriving factors that resulted in initiating Pharmacy andTherapeutics Committee (PTCs) in developed countrieslike Germany, Australia, Canada, Ireland, and Holland,along with other countries that have utilized PTCseffectively to optimise therapeutic health outcomes forpatients as well as economic benefits for hospitals(Thurmann et al, 1997; Weekes and Brooks, 1996; Feld,1986; Ferrando and Henman, 1986; Mannebach in Fijn etal, 1994). Developed countries have traditionally usedPTCs to initiate and maintain rational use of medicinesprograms at hospitals. Internationally, hospitals indeveloped countries have had PTCs for over 70 yearswith built-in methods to monitor and evaluate theirperformance (Thurmann et al, 1997; Summers andSzeinbach,1993; Bochner et al, 1994; Rucker, 1988;Mehr 2006). The individual activities of PTCs differwhile maintaining a common theme and approach ofadvisory and educational activities to maximize therational use of medicines. The beneficial effect ofhospital PTCs in monitoring and promoting quality useof medicines and containing costs in hospitals and otherinstitutional settings has been generally well-accepted inIndian Journal of Pharmacy PracticeReceived on 02/03/2009 Modified on 13/03/2009Accepted on 16/03/2009 © APTI All rights reservedijoppPharmacy and Therapeutics Committee in Bangalore Institute ofOncology - Promoting Rational Pharmaceutical ManagementDivya Hariharaputhran, Sunitha C. Srinivas, Ramesh S. Billimaga, Ajai Kumar B.S1, 3Bangalore Institute of Oncology, Bangalore, India2Rhodes University, South Africa4HealthCare Global Enterprises Ltd, Bangalore, India*Address for correspondence: s.srinivas@ru.ac.zaAbstractBangalore Institute of Oncology (BIO), a Comprehensive Cancer Center operating since 1989 has initiatedPharmacy and Therapeutics Committee (PTC) in 2007 as a forward looking step in promoting rational use ofmedicines. The first step in establishing role of PTC was to carry out ABC Analysis of Anti-Cancer Drugs procured atBIO for the period of October 2006 to September 2007, according to Management Sciences for Health (MSH) andWorld Health Organization (WHO) guidelines. ABC Analysis provided a comprehensive and clear picture ofconsumption of chemotherapy medicines. The number of brand names procured for individual medicines were alsocollated. Constructive debate amongst PTC members resulted in making the decision to streamline the procurementof only three brand names for each medicine that had numerous brands procured earlier. PTC members of BIO haveconstructively utilized the forum in further improvising the pharmaceutical management as a first step inestablishing PTC as a decision making body for rational use of medicines.Key words: Pharmacy and Therapeutics Committee; ABC analysis; Rational use of medicinesdeveloped countries. Unfortunately, there has been littlecritical evaluation of the clinical or economic impact ofthis approach in developing countries.PTCs have been mandated standards in hospital settingsin the USA even before 1960s (Bagozzi, 2005) for safeand cost effective use of medicines in hospitals. In thiscontext there is a need to highlight an important conceptthat maximum expenditure is not necessarily the onlymethod to achieve optimal health benefits. Developedcountries use the concept of balancing therapeuticefficacy with cost and not just striving for costeffectiveness. Formularies are updated by using differentapproaches to evolve decision-making methods(Bagozzi, 2005). These include inventory managementapproach, cost accounting approach and criteria basedapproach, to develop and manage an effective formulary.The WHO in promoting the rational selection ofmedicines has used the same concept by highlightingfour paramount features to be considered, which are:efficacy, safety, quality and cost of medicines (WHO,2001) . The rich countries have used the same conceptsdespite lack of financial constraints in order to balancethe expenditure without subrogating the quality of careprovided to patients. Hence the policies in developedcountries have supported PTCs for many years, by usingPTCs as mandated standards in health care organisations(Hochla and Tuason, 1992). Australia considers PTCs46

pivotal to the rational use of medicines (Weekes and This article describes initiatives in rationalBrooks, 1996) and it has been shown that effective PTCs pharmaceutical management as a part of the newlyplay a very active part in educational, communication initiated PTC's activities of Bangalore Institute ofand advisory roles when clinicians, pharmacists and Oncology (BIO). BIO was founded in 1989 as thenursing representatives work together with flagship unit of Banashankari Medical and Oncologyadministrative personnel on PTCs. Based on this proven Research Center Ltd (BMORC). BMORC, initiallyevidence from developed countries, some developing incorporated as a Private limited Company on 13countries such as Brazil (Cruz and Paola, 2006) and Laos November 1986, became a public limited company in(Vang, 2006) have actively adopted the concept of PTCs 1992. It was the first private Comprehensive Cancerin their hospitals to advocate rational therapeutics that Hospital in Bangalore and Karnataka. The idea for such apromote evidence-based medicine along with clinical hospital was initiated and is managed, by like-mindedeffectiveness and not just cost effectiveness.and dedicated cancer specialists who realized that thePharmaceutical management as proposed by theexisting facilities in the government hospitals were notManagement Sciences for Health (MSH) (Quick et al,sufficient to meet the demands and the private sector1997) and the World Health Organization (WHO)needed to step in. BMORC manages and operates BIO, ainvolves four functions: Selection, Procurement,comprehensive cancer center which started its services inDistribution and Use. This cycle requires support of legal1989 with 5 consultants and 30 beds. It is now a 145-bedand policy framework as well as management supporthospital with over 60 consultant physicians and a staffthat comprise financing, information management,strength of 546 people. BIO treats nearly 3000 newhuman resources and organization. Analytical techniquescancer patients every year, and around 110 patientsare designed in developed countries and cost-consciousreceive radiotherapy every day. Besides, the dailycountries to identify and control excess costs inoutpatient attendance exceeds 300. Nearly 1800 majorpharmaceutical management. Even by the 1980s,operations are performed every year. These numbers aredeveloped countries spent about 100 times as much onever increasing.health and 20 times as much on pharmaceuticals, on a perBIO's PTC was initiated in October 2007, with thecapita basis, when compared to developing countriesobjective of promoting rational use of medicines. The(Patel, 1983) and this trend continues to be predominant.PTC is a standing hospital committee responsible,Hence, industrialized countries have adopted techniquesthrough its chairman, to the Hospital executive board. Itto contain costs. This resulted in techniques such as ABCis a policy recommending body to the medical staff andanalysis and Therapeutic Category analysis to quantifyadministration of the hospital on matters related to thecosts and identify areas where costs could be reducedtherapeutic use of drugs. Improved health and economic(Quick et al, 1997; Quick 1982). Cost reducing strategiesoutcome of the hospital care, particularly those related toare aimed at increasing the effectiveness and efficiencythe medication remains the core objective of the PTC.of pharmaceutical supply.MethodologyABC analysis is also known as Pareto analysis. It is aPharmacy and Therapeutics Committee of BIO decidedwell-known method in inventory management, and is ato use the concept of ABC Analysis for rationalizing theuseful tool in analyzing consumption patterns and thedecisions of pharmaceutical procurement ofvalue of total consumption. A Canadian study highlightsAntineoplastic medicines to start with.the extent to which cost effectiveness evaluation is aABC analysis ranks a set of pharmaceuticals byuseful input in decision-making moving beyondcalculating the expenditure on each medicine as aexamining budgets and towards broader balancedpercentage of the total expenditure on all medicines in thebenefits of therapeutic outcomes with economicset. It is a method advocated by WHO and MSH foroutcomes (Dugal et al, 2002). This approach is a directassembling data to determine where money is being spentconsequence of growing concern about rising health care(Quick et al, 1997).costs due to pharmaceuticals as the main component of a. All items purchased are listed according to year andexpenditure (Levy and Gagnon, 2002; Fernandes, 2002). unit cost.Cost-cutting strategies from policy makers, hospital b. Consumption quantities for each are entered.administrators, and health care professionals generally c. Value of consumption is calculated for each bytargeted pharmaceutical expenditures first.multiplying the unit cost by the number of units47

consumed or purchased to obtain the total value for medicines to all their citizens.each item.Developed countries such as New Zealand resorted tod. The values of all items is then totaled at the bottom of intervention in pharmaceutical management bythe column.highlighting the need for better information to makee. The percentage of total value represented by each item effective medicines available without bankrupting theis calculated by dividing the value of each item by the health care system (Brougham, 2002). One of the firsttotal value of all items.steps most developed countries adopted is computerisingf. The list is rearranged to rank the items in descendingthe procurement process and documenting the usage oforder by percentage of total value, starting at the topmedicines. Studies reports the extent to which theirwith the highest value.purchasing and inventory control of pharmaceuticalsg. The cumulative percentage of total value of each itemimproved by initiating computerised inventory control,is calculatedResultswhich progressed into formulary management and otherConcept of ABC Analysis was used for Anti-Cancer related interventions in pharmaceutical managementstmedicines procured for the period from 1 October 2006- (Rubin and Keller, 1983; McAllister, 1985). On similarth30 September 2007.The percentage value of procured lines BIO has been operating with the computerisedmedicines with the highest, second highest and least inventory for procurement which made it easy to havenumber of brand names were tabulated. Docetaxel ready access to the data for ABC Analysis. Based on ABC(18.91%), Gemcitabine (9.37%) and Paclitaxel (8.87%) analysis and decisions taken to promote rational use ofwere in the list of percentage value of ABC Analysis for medicines, formulary management is in the process ofmedicines with the highest number of brand names. Table being initiated at BIO.ABC analysis in conjunction with computerisation is one1 shows the percentage value of ABC analysis forof the common methods adopted to optimise inventory.medicines with second highest number of brand namesThe reason for the majority of health institutions toand the least number of brands is shown in Table 2.ABC Analysis which was done for the first time in the initiate inventory management techniques is due to theinstitution gave a comprehensive and clear picture of recognition of raising pharmaceutical budgets and theoverall consumption of chemotherapy medicines for a realisation by hospital administrators that reducing theperiod of one year. The complete details of individual pharmacy budget is an effective method of containingconsumption of chemotherapy medicines and number of institutional costs (Hutchinson et al, 1989).brand names procured for individual medicines were Consequently ABC analysis has become a popularobtained. This helped in making decisions to streamline method of quantitative measurement of inventory controlthe procurement of only three brand names for each (Noel, 1984). Thus, an efficient and productivemedicine that had numerous brands procured earlier. purchasing system results in cost savings (Bair and Lee,Discussion1984) leading to ABC analysis becoming one of theThe constant monitoring of programs in developed management techniques. Similarly in BIO, PTC decidedcountries helped in identifying increasing pharma- to list only three brand names based on criteria like costceutical expenditures. A Canadian study reports growth and extent to which they are prescribed instead ofof pharmaceutical expenditure as being close to double procuring all available brands or brands based onthe rate of growth in other health care expenditure clinicians' choices, which is increasing the cost of(Willison, 2002). Similarly, a study in Italy reports inventory. It was decided there should also be the optiongrowth of 11% per year in the last five years resulting in of two more additional brand names in the list and forpharmaceutical expenditure becoming a challenge in the those additional item the clinicians will have to wait tillhealth care system (Rocchi et al, 2004). In response to the medicine is procured.constant increases in pharmaceutical budgets, developed PTCs have been widely accepted both in the developedcountries faced the challenge by introducing various and developing countries as these represent a voluntaryinterventions. It required them to make hard decisions and advisory control strategy with physicians in a centralabout fundamental values in their health care systems position (WHO, 2004). Many PTCs report their activities(Laupacis, 2004). The need to balance benefits of and one of them reported the important feature requiredmedicines with costs was the prime issue in order to for PTCs to be successful, as “a well-prepared agenda,provide accessibility, equity, and affordability of good educational material, active members and strong48

.leadership” (Cohen, 1984). A study reported the reasonfor success of their PTC as an 'evolution' rather than a'revolution' and an 'educational' rather than'confrontational' approach. Their members view theirinvolvement in the PTC as a forum of “valuableinteraction that helped them stay at the forefront ofimportant therapeutic advancements”(Hinthorn andGodwin, 1989). Unless physicians see the benefit of theirinteraction in PTC and perceive that benefit as importantfor their clinical decisions, it is difficult to expectownership of a PTC concept. The profile of thecommittee and mechanics of its functioning strengthenPTCs. BIO's PTC has adopted these principles to the bestpossible extent by providing a central role for cliniciansto make decisions in an evolutionary manner.Constructive debate followed by buy-in of clinicians toallow procurement of only three brand names forchemotherapeutic agents instead of all brand names,demonstrates the steps taken in the direction of rationalpharmaceutical management.National Health Services hospitals in the UK use PTCseffectively to control the introduction of new medicinesby applying principles of evidence-based medicine(Jenkings and Barber, 2004). Overall, the traditionalroles of PTCs have been in advisory capacity and aspolicy-recommending committees within health caresystems, for promoting rational use of medicines. Theseroles expanded to incorporate Drug Utilizationevaluations, medical staff education, continuous qualityimprovement, formulary restrictions and therapeuticinterchange (Wade, 1996). Evidence from developedcountries has shown that unless the PTC has widerepresentation from all key stakeholder departments, thefocus simply remains on cost containment rather thanclinical efficacy, which would defeat the purpose of aPTC (Woodhouse,1994; Borreson, 1986). On similarlines BIO's PTC is well represented by all key stakeholders under the strong leadership resulting inevolutionary steps taken towards implementinginstitutional rational use of medicines.Traditionally, PTCs have been used to steer the process ofmaintaining updated formularies at hospitals. A study inMalaga, Spain, shows how hospital policies operatingtheir formulary can be used to maintain the optimalbalance of using new medicines while considering costcontainment. The hospital reports potential therapeuticand economic benefits as well as educational benefitsresulting in uniformity of pharmaceutical use. A studyreports their PTC as instrumental in establishing a“flexible and dynamic formulary in an ever changinghealth care environment”(Zoloth, 1989). Another studystresses the importance of communicating updatedformulary decisions to medical staff. This educationalintervention plays a vital role in advocating rationaltherapeutics (Dreyfus and Bender, 1987). Theseprinciples are being adopted in decision making forinitiating and maintaining a formulary at BIO.PTCs have been known to achieve objectives such asavailability of safe, efficacious, and quality medicines atan affordable price (WHO, 2004). The shift in thedecision-making authority from the physicians to thePTCs is likely to be resisted especially since physicianstraditionally hold an influential profession withextensive freedom to prescribe. The negative attitudetowards a control body could be reduced by projecting aneed for information and the rationalization of drugtherapy and by advocating economic prescribing, whichis being adequately addressed in BIO.Table No. 1: Percentage value of ABC Analysis for Medicines with second highest number of Brand NamesNames of Medicines % Value from ABC AnalysisDoxorubicin7.138%Oxaliplatin 6.453%Carboplatin 2.630%Temozolamide 1.535%49

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No.2: Percentage value of ABC Analysis for Medicines with least number of Brand NamesNames of Medicines% Value from ABC AnalysisRituximab 15.951%Cetuximab 6.194%Traztuzumab 2.649%Bevacizumab 2.135%Epirubicin 1.981%Gefitinib 1.795%Capecitabine 1.481%Cisplatin 1.458%Vinorelbine 1.309%Fludarabine 1.205%Irinotecan 1.196%Ifosfamide 1.020%Goserelin 0.735%Letrozole 0.733%Thalidomide 0.726%Dacarbazine 0.617%Bleomycin 0.390%Cytarabine 0.382%Exemestane 0.312%Cyclophosphamide 0.296%Erlotinib 0.255%Etoposide 0.201%Asparginase 0.173%Anastrazole 0.158%Tamoxifen 0.153%Melphalan 0.132%Chlorambucil 0.132%5-Fluorouracil 0.107%Vinblastine 0.104%Daunorubicin 0.095%Bortezomib 0.094%Dactinomycin -D 0.086%Lenalidomide 0.083%Leuprolide 0.078%Arsenic Trioxide 0.062%Vincristine 0.057%Imatinib 0.048%Methotrexate 0.047%Hydroxy Urea 0.040%Megesterol 0.028%Altretamine 0.025%Lomustine 0.018%Mitoxantrone 0.007%Mitomycin 0.005%Interferon 0.002%50

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27. Rubin H, Keller DD. Improving a pharmaceuticalpurchasing and inventory control system. Am J HospPharm 1983; 40(1):67-70.28. Rucker TD. Quality control of hospital formularies.Pharm World Sci 1988; 10(4):145-150.29. Summers KH, Szeinbach SL. Formularies: the role ofpharmacy and therapeutics (P&T) committees. ClinTher 1993; 15(2):433-441.30. Thurmann PA, Harder S, Steioff A. Structure andactivities of hospital drug committees in Germany.Eur J. Clin Pharmacol 1997; 52(6):429-435.31. Vang C, Tomson G, Kounnavong S, SouthammavongT, Phanyanouvong A, Johansson R, et.al. Improvingthe performance of Drug and TherapeuticsCommittees in hospitals – a quasi-experimental studyin Laos. Eur J Clin Pharmacol 2006; 62(1): 57-63.32. Wade WE, Spruill WJ, Taylor AT, Longe RL,Hawkins DW. The expanding role of pharmacy andtherapeutics committees. The 1990s and beyond.Pharmacoeconomics 1996; 10(2):123-128.33. Weekes LM, Brooks C. Drug and TherapeuticsCommittees in Australia: expected and actualperformance. Br J Clin Pharmacol 1996; 42(5):551-557.34. Willison DJ. More of the same is not enough. HealthcPap 2002; 3(1):47-55.35. Woodhouse KW. Drug formularies--good or evil?The clinical perspective. Cardiology 1994;85(1):S36-40.36. World Health Organisation. How to develop andimplement a national drug policy. 2nd edition.Geneva. 2001.37. World Health Organisation. Drug and TherapeuticsCommittees- a practical guide. Available from: URL:WHO/EDM/PAR/2004.1. France.38. Zoloth A, Yon JL, Woolf R. Effective decisionmakingin a changing healthcare environment: a P &T Committee interview. Hosp Formul 1989;24(2):85-87.52

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIAbstractBoth macrolides as well as cephalosporins are widely used in the treatment of various lower respiratory tractinfections either alone or in combination. The most commonly prescribed macrolide is azithromycin, generally incombination with different cephalosporins. The objectives of the present study were to find out the differentcombinations of azithromycin and cephalosporins generally prescribed, compare their efficacy, safety (adverse drugreactions) and cost. A prospective study was conducted in the medicine ward at St. Martha's Hospital, Bangalore.The data was analyzed to interpret different parameters of the study. Efficacy was determined based upon the clinicalresponse (reduction in symptoms) and length of hospital stay. Safety was determined by assessing the occurrence ofADR and their severity. Cost of treatment was calculated by cost effective analysis. In the study period, 88 patientswere included based on the inclusion criteria. Results revealed that different combinations prescribed wereazithromycin + cefotaxime, azithromycin + ceftriaxone and azithromycin + cefuroxime. The most commonlyprescribed combination was found to be cefotaxime with azithromycin. The cefotaxime group showed statisticallysignificant difference in the reduction of clinical symptoms thereby indicating greater efficacy. 18% of the patientsexperienced ADRs which were mild in nature with none severe indicating that all the combinations were safe. Thecost effective analysis showed that combination of azithromyin and cefotaxime is most economical.Key words: Antibiotics, Organisms, Antibiotic use, PediatricsINTRODUCTIONRespiratory tract infections (RTI) are very common in the budgets. In most of the adults with LRTI, the illness iscommunity and are one of the major reasons for visiting self-limiting and its course will not be modified by1to primary care physicians . The broad diagnosis of RTI antibiotic therapy, representing viral or clinically nonincludesthe two principal sub-diagnoses of lowerrelevant bacterial diseases. However, failure to initiaterespiratory tract infection (LRTI) and upper respiratoryantibiotic therapy within four hours in cases of2tract infection (URTI) . Community-acquired lowercommunity acquired pneumonia is already associatedrespiratory tract infection is a common cause of acute6with an increased mortality. The major problem in theillness in adults. The spectrum of disease ranges frommild mucosal colonization or infection, to acutemanagement of the LRTI is the inability to determine the7bronchitis or acute exacerbation of chronic bronchitis causative micro-organism in majority of patients .(AECB) or chronic obstructive pulmonary disease There are great systematic differences in the prescription(COPD), to overwhelming parenchymal infection in of antibiotics, both overall and for LRTI, between3patients with community-acquired pneumonia (CAP) . countries and between different healthcare providers in8The term LRTI includes a wide range of diseases which the same country . The "first generation" of guidelineshave different underlying pathologies and etiologies, e.g. was mostly consensus-based, whereas those published in4, 5acute bronchitis and pneumonia . In the out-patient 2000/2001 are at least partly evidence-based. However,setting, LRTI account for the majority of all antibiotics there is still a lack of evidence in many areas of the LRTIp r e s c r i b e d , b u r d e n i n g h e a l t h c a r e d r u g field, and, in addition, interpretation of the availableIndian Journal of Pharmacy PracticeReceived on 05/02/2009 Modified on 13/03/2009Accepted on 16/03/2009 © APTI All rights reservedijoppEfficacy and Safety of Azithromycin with Various CephalosporinsUsed in Treatment of Lower Respiratory Tract Infection1 2 3Imran Ahmad Khan , Shobha Rani. R.H , Geetha Subramanyam1. Sr. DSA, Quintiles, Bangalore2. Department of Pharmacy practice, Al-Ameen college of Pharmacy, Bangalore-5600273. Dept. of Medicine, St. Martha’s Hospital, Bangalore*Address for correspondence: iamkhan@quintiles.com9evidence is variable in some cases .MATERIALS AND METHODSThe present study was conducted at medicine wards ofSt. Martha's Hospital, Bangalore which is 850 bedded53

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009tertiary care teaching hospital providing specializedhealth care services. Ethical clearance was obtained fromthe Institutional review board, St. Martha's Hospital, andan Informed consent was taken from the patients beforestarting the study. The period of study was 8 months. Alladult and geriatric hospitalized patients of medicinedepartment who were diagnosed with lower respiratorytract infection being prescribed with combination ofazithromycin and cephalosporin during the study periodand who were willing to participate in the study wereincluded. Out patients, Pregnant/lactating patients,Pediatric patients, Non consenting patients werecategorized under exclusion group.In this prospective study, data was collected from casesheets of in-patients diagnosed with LRTI. A detaileddescription of demographic details, Presentingcomplaints, Past History, Personal History, FamilyHistory, Drug history, Laboratory parameters was taken.Patient follow up was carried out until discharge.Efficacy was determined based upon the clinicalresponse i.e. reduction in the symptoms such as sputumproduction, cough, wheezing, dyspnoea, fever,discolored sputum and length of hospital stay. Thepatients were monitored throughout till discharge and thesymptoms were noted at regular intervals of three days.The patients were also monitored for any adverse drugreactions during the treatment.Table No.1Gender n %MaleFemale52Table No.25936 41Age n %20-29 4 530-39 16 1840-49 19 2250-59 29 3360-69 10 11= 70 10 11Cost of treatment was calculated by “cost effectiveanalysis”. It is an economic evaluation method ofpharmacoeconomics where cost is measured in monetaryterms and consequences are measured in non-monetaryunits. Cost effective analysis is used when there is singlemeasurable dimension of effectiveness for bothtreatments. This method is used when it is necessary tomeasure both cost and clinical outcomes of drugs.The cost effective ratio for each treatment option iscalculated. This ratio is total cost of the drug divided bythe number of units of output (benefit). In this case, theoutput is reduction in the symptoms on the seventh day ofthe treatment. Preferred drug is the one with lower costper unit of output or health improvement. The differencein the reduction of symptoms in different treatmentgroups was statistically analyzed by Chi- square test.RESULTSAfter appropriate scrutiny 88 patients met the inclusioncriteria and were enrolled for the study during a period ofJuly 2007 to February 2008. Among the 88 patients thatwere included, 52 (41%) were male and 36 (59%) werefemale. The range of age of patients was between 23 to 88years. Maximum number of patients 29 (33%) were in theage group of 50-59 years, depicted in table nos 1 & 2.Patients were addicted to different habits such assmoking, alcohol and tobacco which affect the state ofdisease. Smoking was found to be the commonest amongall the patients who accounted for 51.14% followed bytobacco 29.55% and alcohol consumption 26.13%.Different LRTI diagnosed are given in table no.3 ofwhich pneumonia was the form of illness in 40% ofpatients making it highest among others.DiagnosisPneumoniaTable No.3Co-Morbid conditions were accounted for the use ofdifferent combinations of antibiotics, of whichhypertension was the most common followed byDiabetes Mellitus. Table no.4 gives the details of thedifferent combinations used for different co-morbidities.n35AECOPD 20AEBA 13BRONCHITIS 20%4023142354

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table.No.4No. of PatientsCo-Morbid ConditionsAzithromycin +CeftriaxoneAzithromycin +CefotaximeAzithromycin +CefuroximeTotalHTN 16 21 7 44DM 14 13 6 33BA 5 9 2 16ANAEMIA 4 5 1 10COPD 3 8 1 12UTI 6 5 4 15RD 7 11 3 21FEVER 7 13 3 23The complaints presented by the patients are listed in table no.5, Majority of the patient (84.09%) complained ofcough followed by sputum production (82.95%). The other symptoms observed were discolored sputum (73.86%),wheezing (53.40%), headache (43.18%), myalgia (39.77%) fever (36.36%), nausea (35.22%) and vomiting(23.86%).Table No.5No. of Patients (%)C linical SymptomsAzithromycin +CeftriaxoneAzithromycin +CefotaximeAzithromycin +CefuroximeTotalsputum pr oduction 84.37 83.72 76.92 82.95cough 81.25 88.37 76.92 84.09wheezing 46.87 62.79 38.46 53.40dyspnoea 25 30.23 23.08 27.27headache 43.75 44.19 38.46 43.18myalgia 37.5 39.53 46.15 39.77fever 37.5 37.21 30.77 36.36na usea 34.37 34.88 38.46 35.22vomiting 25 23.25 76.92 23.86oxygen used 21.87 20.93 30.77 22.72discolored sputum 75 79.06 53.85 73.86The various laboratory parameters which were evaluated were WBC, ESR, Platelet count, PaO2, PaCO2, HCO3,and SaO2. The combinations of Macrolide and cephalosporin therapy prescribed to the patients for the treatment oftheir relevant conditions are given in Table No.6.Table No.6COM BINATIONSn(% )A zithromyc in + Ceftriaxone 32 36A zithromyc in + Cefotaxime 43 49A zithromyc in + Cefuroxime 13 1555

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Treatment details based on the type of ailment are listed in table no 7.Table No.7No. of Patients (%)DiagnosisAzithromycin +CeftriaxoneAzithromycin +CefotaximeAzithromycin +CefuroximeTotalPNEUMONIA 37 43 20 40AECOPD 40 45 15 23AEBA 38 54 8 14BRONCHITIS 30 60 10 23The length of hospital stay of patients ranged from 2 to 12 days as shown in Table No.8, minimum stay wasobserved in azithromycin + ceftriaxone combination.Table No.8No. of Patients (%)No. of DaysAzithromycin +CeftriaxoneAzithromycin +CefotaximeAzithromycin +CefuroximeTotal1 - 4 0 4.65 7.7 3.45 - 8 56.25 69.77 15.38 56.829 - 12 43.75 25.58 76.92 39.78Further evaluation of symptoms was done individually to assess their severity. The results are depicted in thefollowing table no 9, 10, 11, 12, 13 & 14Table No. 9 CHANGE IN SPUTUM PRODUCTIONPAT IE NTS (% )T RE ATM E NTDay 0 (B ase line) Day 7SevereM ild/M oder ateAb sent Disch ar ged Severe M ild/M oderate AbsentAzi th romyci n +Ce ftriaxoneAzi th romyci n +C efotaxime84.4 12.5 3.1 21.9 43.8 9.4 25.083.7 9.3 7.0 34.9 25.6 0 39.5Azi th romyci n +Ce furoxime84.6 0 15.4 7.7 46.2 30.8 15.42 = 3.635 P = 0.458 2 = 19.844 P = 0.00356

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No. 10 CHANGE IN COUGH2 = 2.901 P = 0.574 2 = 9.892 P = 0.129Table No. 11 CHANGE IN WHEEZINGPATIEN TS (% )TREATMENTDay 0 (Base line) D ay 7SevereMild/ModerateAbsent Disc harged SevereMild/ModerateA bsentAzithromycin +CeftriaxoneAzithromycin +CefotaximeAzithromycin +Cefuroxim e46.9 12.5 40.6 21.9 9.4 18.8 50.062.8 11.6 25.6 34.9 0 14.0 51.261.5 23.1 15.4 7.7 23.1 23.1 46.22 = 4.325 P = 0.364 2 = 12.075 P = 0.06057

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No. 12 CHANGE IN DYSPNOEAPATIENTS (% )TREATMEN TDay 0 (Base line) Visit 2SevereMild/ModerateAbsent Discharged SevereMild/ModerateAbsentAz ithrom ycin +CeftriaxoneAz ithrom ycin +CefotaximeAz ithrom ycin +Cefuroxim e25.0 50.0 25.0 21.9 6.2 31.2 40.630.2 39.5 30.2 34.9 0 16.3 48.853.8 30.8 15.4 7.7 23.1 46.2 23.12 = 4.290 P = 0.368 2 = 18.069 P = 0.006Table No. 13 CHANGE IN FEVERPA TIENTS (%)TREATMEN TDay 0 (Base line) Day 7No Yes Disc harged No Y esA zithromycin + Ceftriaxone 62.5 37.5 21.9 56.2 21.9Azithromycin + Cefotaxime 62.8 37.2 34.9 53.5 11.6A zithromycin + Cefuroxime 38.5 61.5 7.7 53.8 38.52 = 2.686 P = 0.261 2 = 7.091 P = 0.13158

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No. 14 Change in color of sputumTREATMENTPATIENTS (%)Day 0 (Base line) Day 7No Yes Discharged No YesAzithromycin + Ceftriaxone 25.0 75.0 21.9 40.6 37.5Azithromycin + Cefotaxime 20.9 79.1 34.9 46.5 18.6Azithromycin + Cefuroxime 23.1 76.9 7.7 30.8 61.52 = 0.174 P = 0.917 2 = 10.079 P = 0.039Table No. 15 Cost Effectiveness ratioCost Effective ratio = Cost of treatment for 7 days / Reduction of sym ptom s by 100%Cost of Treatment = Cost of Drug + O ther associated costs (Syringe)Cost Effective Ratio*TREATMENTSputumProductionCough Wheezing Dyspnoea FeverDiscolouredSputumAverageAzithromycin+ CeftriaxoneAzithromycin+ CefotaximeAzithromycin+ Cefuroxime1497 1497 1621 3234 3897 1621 22301251 1042 1158 2408 2841 1202 16501822 2272 1822 2280 3043 4545 2631*in Rs for 100% decrease in symptomsAzithromycin + Cefotaxime has least cost effective ratio and is therefore most cost effective59

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009DISCUSSIONsignificant difference in the symptoms namely cough,During the study period, a total of 143 LRTI patients were wheezing and fever with different combinations.admitted to the medicine units. Out of these, 88 patients The length of hospital stay ranged from 2 days to 12 days,(61.5%) met the inclusion criteria and were included in according to Table No.8, maximum patients (56.82%)the study. Out of total 88 patients, 52 (59%) were male got discharge between 5 – 8 days. In case of cefotaximeand 36 (41%) were female as shown in Table No. 1.The and ceftriaxone group maximum patients i.e. 69.77% andage of patients ranged from 23 to 88 years. Maximum 56.25% respectively got discharge between 5 – 8 daysnumber of patients 29 (33%) were in the age group of 50- whereas in case of cefuroxime group maximum patients59 years whereas 4 (5%) patients belonged to the age (76.92%) got discharged between 9 – 12 days. Based ongroup of 20-29 years as shown in Table No. 2.Out of 88 the number of days for discharge, the patients ofpatients 35 (40%) were diagnosed with Pneumonia cefotaxime group were found to have improved andfollowed by 20 patients with AECOPD (23%), 20 discharged earlier compared to the other two groups.patients with bronchitis (23%) and 13 patients with Thus the combination of azithromycin and cefotaximeAEBA (14%). The subjects were presented with different seemed most effective.co-morbid conditions such as hypertension, diabetes Safety of the treatment was evaluated by monitoring themellitus, fever, bronchial asthma, renal disorder, chronic adverse drug reactions of the treatment groupsobstructive pulmonary disease, urinary tract infection throughout the study period. 21.59% of patients hadand anemia. Among these co-morbid conditions, the complaints of ADRs. Cefotaxime group of patientmost common conditions were hypertension (44 experienced lesser number of ADRs compared to thepatients) and diabetes (33 patients).ceftriaxone and cefuroxime group. In case of patientsFrom Table No.6, it was observed that maximum patients given the combination of azithromycin with cefotaxime,(43 patients and 49 %) were prescribed with the there was no complaint of arthralgia, gingivitis,combination of azithromycin + cefotaxime followed by abdominal pain and heart burn, but CNS side effects suchazithromycin + ceftriaxone (32 patients and 36 %) and as agitation and dizziness were found. However, none ofazithromycin + cefuroxime axetil (13 patients and 15%). the ADRs were severe and life threatening. Hence, weEFFICACYcan say that all the three combinations were safe.Azithromycin was the common antibiotic prescribedThe cost of the therapy was calculated by cost effectivealong with the cephalosporin to the enrolled patients at aanalysis. According to the Table No. 15, cefotaximedose of 500mg O.D. The minimum dose of cefotaximecombination was found to be more economic comparedprescribed to the patients was 1g B.I.D and the maximumto the ceftriaxone and cefuroxime combination. Thedose was 2g Q.I.D. In case of ceftriaxone, the minimumaverage cost effective ratio of the cefotaximedose was 1g B.I.D and the maximum dose was 2g T.I.D.combination was found to be Rs. 1650.00, whereas inIn case of cefuroxime, the minimum dose prescribed tocase of ceftriaxone and cefuroxime combination thethe patients was 1g B.D and the maximum doseaverage cost per treatment for 100 % reduction inprescribed was 2g Q.I.D.symptoms was found to be Rs. 2230.33 and Rs. 2631.27The efficacy of medications was evaluated mainly byrespectively.observing the reduction of symptoms from the time ofCONCLUSIONthadmission up to the 7 day of treatment. According to theThe various cephalosporins used along with theTable Nos. 9,10,11,12,13 & 14, it was found thatazithromycin for the treatment of LRTI in the medicinereduction in symptoms was greater in case of thewards of the hospital were cefotaxime (3rd generation),combination of azithromycin with cefotaxime groupceftriaxone (3rd generation) and cefuroxime axetil (2ndcompared to the other two groups. As the percentage ofgeneration). The combinations prescribed werereduction in severe symptoms was greater inappropriate with respect to the diagnosis. All the threecombination of Azithromycin with cefotaxime (58%),combinations showed a decrease in the clinicalcompared to ceftriaxone (40.6%) and cefuroxime(36.9%) group of patients, cefotaxime combinationsymptoms of the patients, but cefotaxime group ofseems more effective in reducing the symptoms.patients showed a faster decrease compared to the otherStatistically there was a significant difference found in two groups. Length of the hospital stay was also less inthe reduction of sputum production and dyspnea betweenthe treatment groups. However, there was no statisticallythe patients treated with cefotaxime and azithromycincombination.60

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Thus it can be concluded that combination ofazithromycin with cefotaxime was more efficacious thanazithromycin with ceftriaxone and azithromycin withcefuroxime axetil.Azithromycin with cefotaxime showed a lesser numberof adverse drug reactions than the other twocombinations. However, ADRs observed in patientstaking all the three different combination were mild innature and none of them were serious and lifethreatening.From the cost effective analysis azithromycin withcefotaxime combination was found to be more costeffective.Thus, it can be concluded that combination ofazithromycin with cefotaxime was the best among thethree combinations in treating the LRTI.REFERENCES1. Lower respiratory Tract infections. Available from:URL:http://www.nhsdirect.nhs.uk/articles/article.aspx?articleId=316&sectionId=9.2. Liberman D, Korsonsky I. A comparative study of theetiology of adult upper and lowert respiratory tractinfections in the community. Diag Microb InfecDisesa 2002; 42:21-28.3. Schouten JA, Hulscher MEJL, Grol RPTM. Quality ofantibiotic use of lower respiratory tract infections athospitals: (How) can we measure it? Clin Infec Diseas2005;41:450-460.4. Seppa Y, Bloigu A, Honkanen PO. Severityassessment of lower respiratory tract infection inelderly patients in primary care. Arch Intern Med2001; 161: 2709-2713.5. Simpson JCG, Hulse P. Do radiographic features ofacute infection influence management of lowerrespiratory tract infections in the community? EurRespir J 1998; 12:1384-1387.6. Liberman D, Shvartzman P. Diagnosis of ambulatorycommunity aquired pneumonia. Scand J Prim HealthCare 2003; 21:57-60.7. Stolz D, Crain MC, Gencay MM. Diagnostic values ofsigns, symptoms and laboratory values in lowerrespiratory tract infection. Swiss Med Wkly 2006;136:434-440.8. PlouffeJ, Schwartz DB. Clinical efficacy ofIntravenous followed by oral azithromycinmonotherpy in hospitalized patients with communityaquiredpneumonia. Anti Microb. Agents chemother200;44:1796-1802.9. Ortqvist A. Treatment of community aquired lowerrespiratory tract infections in adults. Eur Respir J2002; 20:40s-50s.61

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIijoppEvaluation of Drug Information Service provided by ClinicalPharmacy Department based on Provider and Enquirers' Perspective1 2 34 5Kuchake V.G , Maheshwari O.D , Surana S.J , Patil P.H , Dighore P.N .1,2,3,4. Department of Clinical Pharmacy, R.C.Patel Institute of Pharmaceutical Education & Research, Shirpur,Dist: Dhule (M.S.), India – 4254055. M.D.(Medicine), Department of Clinical pharmacy, Indira Gandhi Memorial Hospital, Shirpur, Dhule,Maharashra-425405*Address for correspondence: msvragavrajan@yahoo.comAbstractHypertension is not a disease but an important risk factor for cardiovascular complication. This type of medicalaudit and appropriate feedback on usage of antihypertensive medications may greatly assist the health careproviders in rational use of medications.The objective of this study was to evaluate the prescribing pattern and drugutilisation of antihypertensive medications in uncomplicated hypertension. Observational and Prospective studywas performed at Indira Gandhi Memorial Hospital, Shirpur, Maharashtra in India. Total 5025 patients visited themedicine ward of Indira Gandhi Memorial Hospital. Among them 244 patients had uncomplicated hypertension.ststFrom 1 July, 2008 to 31 December, 2008 Hypertensive medications were divided into 2 main categories;Monotherapy and Combination therapy was defined and discussed separately. During 6 months study period, 510prescriptions were collected, among them 244 including (132) female & (112) male patients were as per inclusioncriteria. Among them, 150 patients were on mono therapy which included 78 female & 72 male patients, comprising54%(81) on Calcium Channel Blockers, 24.67%(37) on â-Blockers, 11.33%(17) on Angiotensin ReceptorBlockers, 6%(9) on Angiotensin Converting Enzyme Inhibitors, 4%(6) on Diuretics respectively, and 38.52% (94)patients on combination therapy. In the view of drug utilisation, it was observed that, the diuretics are lessprescribed and calcium channel blockers are frequently prescribed medications in management of hypertension.So, it requires further improvement of prescription pattern of antihypertensive medication for better patient healthcare.Key Words: Anti-hypertensive drugs, drug utilisation, hypertension, prescribing patternINTRODUCTIONHypertension, a major risk factor for cardiovascular Socio-economic, behavioral, nutritional and public(CV) disease and stroke and one-quarter of the adult health issues can lead to increase in CV diseasepopulation of Western societies suffer from throughout the world. A plethora of new drugs are now(1)hypertension. Increasing awareness and diagnosis of available, and the quality of life of such people can behypertension, and improving control of blood pressure improved considerably. A number of drugs in variouswith appropriate treatment, are considered critical public(4-5)combinations are generally used for effective long-health initiatives to reduce cardiovascular morbidity and term management. Therefore, drug utilisation studies,(2)mortality. The Seventh Report of the Joint Nationalwhich evaluate, analyze the medical, social andCommittee on the Detection, Evaluation, and Treatmenteconomic outcomes of the drug therapy, are moremeaningful and observe the prescribing attitude ofof High Blood Pressure (JNC VII) is the most prominent(6,7)physicians with the aim to provide drugs rationally .evidence-based clinical guideline for the management of(3)The present prescribing study for antihypertensive drugshypertension. Poor control on hypertension can lead towas undertaken in the outpatient department (OPD) atthe development of ischemic heart disease, heart failure,Indira Gandhi Memorial (IGM) hospital, Shirpur (ruralstroke & chronic renal insufficiency.area) Maharashtra for the purpose of assessing thecurrent trend of prescribing pattern of anti-hypertensiveIndian Journal of Pharmacy PracticeReceived on 06/01/2009 Modified on 13/02//2009drugs. This kind of medical audit can help to make theAccepted on 17/02/2009 © APTI All rights reservedprescribing practice of physicians more rational and62

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009prudent and thereby help in improving the patient healthcare.characteristic of all 244 uncomplicated hypertensivepatients is seen in Table No. 1.MATERIALS AND METHODFigure No. 1 and 2 shows the social history of patientsThe observational and prospective study was carried out like their occupation and education. The data suggestedat IGM hospital to collect the information of the patients.The Protocol was prepared as per World Healththat elderly patients having more hypertension amongmore patients were rest. Illiterates are more prevalence(8)Organization (WHO) guidelines and study was than literates.approved by Institutional Human Ethical Committee Overall, 150 (61.48%) patients were treated with a single(IHEC) of R.C.Patel Institute of Pharmaceutical anti-hypertensive drug and 94 (38.52%) patients wereEducation & Research, Shirpur.treated with anti-hypertensive drug combinationsStudy design: This study was observational and suggesting that mono-therapies to be dominant in thisprospective conducted over the 6 months periods from type of rural area.st st1 July 2008 to 31 December 2008 for assessing Table No 2 shows the details of patients, who wereprescribing pattern and drug utilisation ofantihypertensive drugs in the management oftreated with monotherapy. Among them, 81 (54.0%)patients were treated with Calcium Channel Blockersuncomplicated hypertension(CCBs), 37 (24.67%) were treated with â-blockers,Study site: The study was carried out at the Medicine 17 (11.33%) with Angiotensin receptor blockers(ARBs),ward of IGM hospital of Shirpur for collection of data. 9(6.0%) were treated with Angiotensin ConvertingStudy setting: The study was carried out on out patients Enzyme Inhibitors(ACEIs), and 6(4.0.%) treated withof medicine ward, who were currently following the diuretic. Calcium channel blockers were the mosttreatment of uncomplicated hypertension in IGM frequently prescribed antihypertensive drugs ashospital, Shirpur.monotherapy.Source of data: All necccesary & relevant information Figure No.3 show details of patients treated withwere collected from out patient department cards, combination therapy. Among them 59, (62.78%) werelaboratory data report, treatment chart and verbal treated with two drugs, 31(32.98%) with three drugs andcommunication with patients.4 (4.25%) were treated with 4 drugs.Collection of data: The format for the collection of the It was observed that eight different two-drug antithedata is prepared as per WHO based guidelines andhypertensive combinations, were prescribed to hyp-Institutional Human Ethical Committee of R.C.Patel ertensive patients (Table no.3), namely: , â –blocker withInstitute of Pharmaceutical Education & Research, CCB 23 (32.98%), ARB with diuretic 18(30.51%), CCBShirpur which involved patient as well as medication with diuretic 6(10.17%), â-blocker with diureticinformation.4(6.78%), ARB with CCB 4(6.78%), ACEI with CCBInclusion criteria: Patients either male or female with2(3.38%), ACEI with diuretics 1 (1.69%) and ARB withage more than 18 years, with History of hypertension orâ-blocker1 (1.69%).currently diagnosed with hypertension and prescribed The CCB with â-blocker was the most frequentlyprescribedtwo-drug combination in overall populationwith antihypertensive medication.Exclusion criteria: Patients with other comorbiditiesfollowed by ARB with Diuretic. The CCB with â-blockerlike diabetes, other cardiovascular disorders, stroke,were less prescribed in male than female patients due toasthma, Chronic Obstructive Pulmonary Disease(9)side effect of â-blockers in male patients.(COPD), arthritis, and other infectious disease.DISCUSSIONStatatical Data AnalysisA Prescription-based survey is considered to be one ofThe t- tests (Unpaired, Two tailed) were used forthe most effective methods to assess and evaluate drugevaluation of mean S.E.M. (Standard Error Mean) of ageutilization of medication. It is also important to considerand blood pressure of patients. A value of P0.05 (twotherecommendations of international bodies ontailed test) was declared as statistically significant.hypertension that help to improve prescribing practice ofRESULTSst stDuring 6 months study from 1 July 2008 to 31 the physicians and ultimately, the clinical standards. ADecember 2008, total 5025 out patients visited the continuous supervision is therefore required throughmedicine ward of hospital, among them, 510 patients such kinds of systematic audit that provide feedbackwere diagnosed with hypertension of which 244 had from the physician and help to promote rational use ofuncomplicated hypertension. The demographic drugs.63

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No.1: Demographic characteristics of 244 uncomplicated hypertensive patients visited at Medicineward of Hospital during 6 months studyAge (in years)Male(n =112)Female(n=132)All patients(n=244)18-30 3 2 5 (2.05%)31-40 9 17 26 (10.66%)41-50 23 39 62 (25.41%)51-60 37 30 67 (27.46%)61-70 24 33 57 (23.36%)71-80 16 11 27 (11.06%)Age (year)Mean± S.E.M.56.57± 1.18(P< 0.0001)54.92±1.07(P< 0.0011)55.68 ± 0.79(P< 0.0001)Blood PressureSystolic (mmHg)Mean ± S.E.M.Diastolic (mmHg)Mean ± S.E.M.151.2 ± 2.56(P

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table No.3: The Pattern of use of antihypertensive drugs in patients treated with two drugs combinationtherapy with different classes.Two drugs combinationMalen=23Femalen=36Total n=59% UtilisationB + C 6 17 23 38.98D + E 10 8 18 30.51C + D 2 4 6 10.17B + D 2 2 4 6.78C + E 2 2 4 6.78A + C 1 1 2 3.38A + D 0 1 1 1.69B + E 0 1 1 1.69n = number of patients A: Angiotensin Converting Enzyme Inhibitors, B: â-blockers, C: Calcium ChannelBlockers, D: Diuretics, E: Angiotensin Receptor BlockersFigure no. 1: Education of Patients.Education of Patients120100102No of patients80604020356729 2958181230342410 12820MaleFemaleTotal0Illterate Primary S.S.C. H.S.C. UnivercityLevelEducation65

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Figure no.2: Occupation of Patients.Occupation of PatientsNo. of patients9080706050403020100Rest House wife Business Worker FarmerMale 33 0 30 33 5 11Female 51 70 0 3 2 6Total 84 70 30 36 7 17OccupationProfessionalsMaleFemaleTotalFigure no. 3: The Pattern of use of antihypertensive drugs in patient treated with combination therapy(i.e. 2 drugs, 3 drugs and 4 drugs) with different classes.Combiantion Therapy706059 (62.77%)No . of Patients5040302031 (32.98%)1004 (4.25%)2 drugs 3 drugs 4 drugsCombination of Drugs*** In this study we collected all details of patients such as his/her name, age, sex, address, phone number,occupation, education, social history, family history, date of check up, present details and also medicationdetails which are medicine name, dose, frequency, route and duration. complaints, blood pressure, diseasediagnosed, associated diseases, medical, past history & past medication66

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009The present prospective study observed that combination and in addition to its favorablehypertension was more prevalent in females than in complementary synergistic effects, â-blockers tend tomales. Monotherapy and combination therapy were both blunt the troublesome complementary reflex tachycardiamore used in females at rates of 59.1% and 40.9% induced by the short-acting dihydropyridine (DHP) classrespectively. Further more, combination therapy seems of calcium channel blockers. The latter may additionallyto be a rational approach to reduce the cardiovascular counteract any peripheral vasoconstriction caused by the(10)mortality . The present study revealed that calcium former. Their combined efficacy has been confirmedchannel blockers were the drugs of choice for without causing adverse drug interaction or poorhypertensive patients as a single drug therapy and overall tolerability. The fixed combination of â-blocker andutilization, followed by â blocker which was less calcium channel blocker provides efficiency andprescribed as a monotherapy. Diuretics are generally tolerability in the treatment of arterial hypertension.recommended as first-line therapy for treatment of Pharmacists play an important role in educating thehypertension as per Joint National committee VII. patient about the drugs and dosage schedule. It wasUtilization of diuretics in the present study was 4.0% as noticed that pharmacists who distribute the medicinesmonotherapy. Lesser use of diuretics in the present study did not give adequate written or oral instructions.may be due to adverse effect of diuretics on glucose CONCLUSION(11)Prescription pattern varies with age, gender and otherhomeostasis and lipid profile .The efficacy of ACE inhibitors and ARB on blood complications associated with hypertension. In view ofpressure was reported to be marked in patients with an often costly drugs for long term treatment, it is necessary(12)activated renin-angiotensin-aldosterone system . This that monitoring of their use, its co-relationship withstudy showed that overall drug utilization of and clinical out comes and quality of life is essential to ensureAngiotensin receptor blockers and ACE inhibitors was the optimal use of health care resources. It is found from11.33% and 6.0% respectively, as monotherapy, which the study that the prescription of diuretics in hypertensionwas lesser in number as compared to other drugs such as is comparatively low whereas the calcium channelcalcium channel blockers and â-blockers (Table no.2) but blockers are widely prescribed. The overall findings ofincreasing prescription rate of angiotensin receptor the study show that there is need for further improvementblockers now days than earlier studies.in the prescription pattern of anti-hypertensivesTiwari et al. suggested that an ideal combination must ACKNOWLEDGEMENTinclude anti-hypertensive drugs possessingThe authors appreciate the co-operation of all the healthcomplementary modes of action that provide acare providers of Indira Gandhi Memorial Hospital andsynergistic anti-hypertensive effect without anypatients who participated in this study.REFERENCESsignificant adverse effects, at low doses. Furthermore,1. Carey RM. Hypertension and hormone mechanisms.the anti-hypertensive drug combination therapy shouldNew Jersey: Human Press; 2007: 6.be able to minimise or counteract the reflex 2. Diprio JT, Talbert RL, Yee GC, Matzke GR, Wells BG,compensatory mechanisms that often limit the fall in Posey LM. A pharmacotherapy physiological(13)blood pressure . In the present study, two-drug approach. 7th ed, McGraw-Hill Companies. 2008:combinations were mostly prescribed (62.78%), 172-3.followed by three-drug combinations (32.98%) and four 3.Hedley AA, Ogden CL, Johnson CL, Carroll MD,drug combination (4.25%) (Figure no.3).Curtin LR, Flegal KM. Prevalence of overweight andIn two-drug combinations, a â-blocker with a calcium obesity among US children, adolescents, and adults.channel blocker (Tablet Amlopin AT combination of JAMA 2004; 291(23):2847–2850.Atenolol 50 mg and Amlodipine 5 mg) were most often 4. Kjeldsen SE, Farsang C, Sleigh P, Mancia G. Worldprescribed (38.98%), Table no.3), followed by a ARB Health Organization; International society ofwith diuretics (Tablet LoasrH50 combination of losartan hypertension. WHO/ISH hypertension guidelines-50 mg and hydrochlorothiazide 12.5 mg) (30.51 %). A â- highlights. Journal of Hypertension 2001; 19:2285-blocker with a calcium channel blocker was prescribed 2288.more in females than males. The more likely reason for 5. Ramsay LE. British Hypertension Society Guidelinethis gender difference may be related to the adverse effect for hypertension management: summary. Brit Med J(14)of â-blockers on sexual function in men .In this form of 1999; 319:630-635.67

Indian J. Pharm. Pract. 1(2), Jan-Mar, 20096. Kapoor B, Raina RK, Kapoor S. Drug prescribingpattern in a teaching hospital. Ind J Pharmacol 1985;17 (1):168.7. Pradhan SC, Shewade DG, Shashindran CH, BapnaJS. Drug utilization studies. National Med J India1988; 1:185.8. Bimo, Chowdhary A, Das A, Diwan V, Kafle KK,Mabadeje B. In: How to investigate drug use in healthfacilities (selected drug use indicator) actionprogramme on essential drugs. WHO officialpublication 1995;68.9. Tiwari H, Kumar A, Kulkarni SK. Prescriptionmonitoring of antihypertensive drug utilisation at thePanjab University Health Centre in India. OriginalArticle. Singapore Med J 2004; 45(3): 117.10. Mancia G, Grassi G. Antihypertensive treatment:past, present and future. J Hypertens 1998; 16:S1-7.11. Prisant LM, Beall SP, Nicholads GE, Feldman EB,Carr AA, Feldman DS. Biochemical, endocrine, andmineral effects of indapamide in black women. J ClinPharmacol 1990; 30:121-126.12. Hansson L. The place of beta-blockers in thetreatment of hypertension . Clin Exp Hypertens 1993;15:1257-1262.13. Chalmers J. The place of combination therapy in thetreatment of hypertension. Clin Exp Hypertens 1993;15:1299-1313.14. Alkhaja KA, Sequeira RP, Damanhori AH, MathurVS. Antihypertensive drug-associated sexualdysfunction: a prescription analysis-based study.Pharmacoepidemiol Drug Safe 2003; 12:203-212.68

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIINTRODUCTIONVaginitis is described medically as an irritation and/orinflammation of the vagina. It is a very common diseaseaffecting millions of women each year. The three mostcommon vaginal infections reported each year arebacterial vaginosis (30-40%), candidiasis due to yeastinfection (20-25%) and trichomoniasis caused byprotozoal infection (15-20%). Vaginal infections canproduce a variety of symptoms, such as abnormal orincreased discharge, itching, fishy odor, irritation,painful urination or vaginal bleeding(1,2,3).Though the infections are not serious in nature, they canbecome chronic and the eradication of such infections isoften difficult. If left untreated, bacterial vaginosis mayresult in increased risk of pelvic inflammatory disease(PID), infertility, pre-term birth, premature rupture ofmembranes, low birth weight, intra-amniotic infections,endometritis, cervical intra-epithelial neoplasia (CIN),post-gynecological surgery infections and increased riskof sexually transmitted diseases (4,5).Indian Journal of Pharmacy PracticeReceived on 10/02/2009 Modified on 19/02/2009Accepted on 19/02/2009 © APTI All rights reservedijoppPreliminary Clinical Study of a Polyherbal Formulation (Wh1) inthe Treatment of Vaginitis1 2 34Vishnu Bapat *, Leena Alfred , Shobha Rani R.H , Pushpa. T. Ksheerasagar ,5 6Geetha Hegde , Soumya. K. Lund ,1. Vaidya Visharad, # 375 First B Main, First Phase, Girinagar, Bangalore 560 0852,3,6. Department of Pharmacy Practice, Al-Ameen College of Pharmacy, Bangalore.4. Retired Professor of Gynaecology, Bangalore Medical College, Bangalore.5. Shreyas Poly Clinic & Laboratory , Chamarajpet, Bangalore.*Address for correspondence: vrbapat@yahoo.co.inAbstractVaginitis is a very common disease affecting millions of women each year with multifactorial etiology. If leftuntreated it can lead to various complications. Current medical therapy may temporarily reduce infection but tendto disrupt the normal vaginal flora. Hence, herbal therapy is gaining popularity in women on account of its reducedside effects and restoration of the normal vaginal flora. With this in view, a preliminary clinical study was conductedusing a polyherbal formulation (WH I), containing herbs with antifungal, antibacterial, antiseptic and astringentproperties. In this prospective clinical study, 36 patients presented with the symptoms of vaginitis of varyingetiology were treated successfully with the polyherbal formulation (WH I) and was found to be safe and effective(83%). The results of this study were found to be significant, thus this study will be extended on a large patientpopulation in future.Key Words: Vaginitis, Polyherbal preparation (WH 1), Clinical Study, Female, bacterial vaginosis,candidiasis,richomoniasis, leucorrhoea.Vaginitis is identified by checking vaginal fluidappearance, vaginal pH and presence of volatile amines(the odor causing gas) and microscopic detection of cluecells 2 (6).Current medical therapy for vaginitis includes the use ofsystemic or topical antibiotic and antifungalpreparations. Vaginitis being a disorder of multifactorialetiology, a single-line therapy is often inadequate andrecurrence is a common complication. Though thesemedications may temporarily reduce infection, theyoften disrupt the balance of good bacteria and frequentlylead to recurrent infection. Studies shows thatvulvovaginal candiasis(VVC) affects three-quarters ofwomen during their lifetimes and use of antibiotics is anacknowledged trigger for VVC, which adversely affectswomen's physical and emotional health (7, 8, 9).Therefore, as an alternative to these medications herbaltherapy is gaining popularity in women on account of itsreduced side effects and restoration of the normal vaginalflora (10,11,12).Ayurvedic herbs are available, which have been listed inayurvedic literatures like Dhanwanthri Nighantu,Bhavaprakash Nighandu, Ashtanga Hrdaya, Sushruta69

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Sanhita, Chakradatta and Nighandu Ratnakara which are simultaneously. Patients were encouraged to report anyof use in treating this condition.adverse reaction to the physician during the course ofCommon herbs such as Dhataki Flower, Musta, treatment.Mocharas, Lodhra, Lata Karanja have actions that RESULTS & DISCUSSIONinclude antifungal, antimicrobial, antiseptic, astringent, 36 patients completed the preliminary clinical study withand demulcents(13). Herbs with astringent activity may the polyherbal preparation (WH1). WH1 reduced theproduce a protective coating on the tissue surface. amount of vaginal discharge significantly in all theTherapeutically, these herbs may reduce irritation, patients both symptomatically and clinically. Significantinflammation, and excessive fluid secretion, and provide results were seen microbiologically in 30 patients (83%).a barrier against infection. Antiseptic and antimicrobial During the study period, 58 patients were enrolled; onlyherbs may work to eliminate bacterial and viral 36 patients completed the study. 22 patients wereinfections, and antifungal herbs may help fight fungal therefore excluded from the study as per the protocolinfections. A list of herbs containing these qualities for design. Hence, statistics of only 36 patients whothe treatment of vaginitis is shown in Table-1.completed the trial has been presented here and theTraditionally, a mixture of powder of the herbs listed inresults were summarized as percentages. Age of patientsTable-1 in the medium of ghee as “Anupana” [vehicle ofranged between 18 and 55 years (Fig.1) which explainsadministration] has been used effectively in the treatmentincidences of risk factors such as child birth, abortions,of vaginitis. However, there has been no documentationpassage of infective organism by infected semen etc inregarding its efficacy and safety.this age group (14). Maximum patients belonged to lowHence, the objective of this work was to take up apreliminary clinical study in a small patient group toincome group. Poor hygienic conditions, ignoranceconfirm the efficacy and safety of this poly herbalabout the proper cleaning and toilet habits and badpreparation (WH1). Therefore, this mixture of powdersnutritional status explains the higher incidence of thisin ghee base was formulated as soft gelatin capsules. The condition amongst this group (14). Duration offormula of this preparation is given in Table 2.complaints varied from less than 1 month (4 days) to 8METHODyears (Fig.2) which further confirms that women areInstitutional Ethical committee clearance was obtained busy in managing the household work without takingfrom Sri Sai Charitable Dispensary, Girinagar, Bangalore sufficient care regarding their own health. 25 patientsand Shreyas Poly Clinic & Laboratory, Chamarajpet, improved with the first course of 10 days treatmentBangalore, where the study was conducted for a period (69%). 7 patients received 2 courses of medicine and 2of six months, from November 2006 to April 2007. patients 3 courses of medicine. 2 patients received moreInformed consent was taken from all patients included inthan 4 courses of medicine without benefit (Fig.3). Thethe study after explaining to them the purpose of theetiology of patients observed by microbiologicalstudy.examination is given in (Fig.4). 17 patients wereInclusion Criteria: All patients presented withsymptoms of vaginitis at the clinic during the studydiagnosed as non specific vaginitis (47%), 14 asperiod of 6 months.Bacterial Vaginitis (39%), 3 as vaginal candidiasis (8%)Exclusion Criteria: Patients with white discharge due to and 1 each as atrophic vaginitis and senile vaginitis (3%).any other clinical condition like fibroid, malignancy etc The swabs taken after 15 days and after one month, whichand pregnant women.assessed the effectiveness of the treatmentAll patients who met the inclusion criteria were recruited microbiologically, showed 83% (30/36) patientsfor the study. These patients were clinically examined improved with treatment and no improvement was seenand a swab was taken from the vaginal discharge and sent in 17% (6/36) of patients (Fig.5). None of the patients into pathological laboratory. All patients were prescribed this series experienced any adverse reactions. Thus, thethe poly herbal formulation (WH 1) thrice a day for 10 polyherbal preparation (WH1) effectively produceddays after food. Two fortnightly follow ups were clinical and microbiological relief in women withconducted and progress was assessed by clinical vaginitis of varied etiology.improvements and confirmed by swab test. If the CONCLUSIONcondition was not improved, another course of treatment The polyherbal formulation (WH1) has shownwas repeated and the sexual partner also treated significant results in the treatment of vaginitis. But this70

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table -1: List of herbs used in the treatment of vaginitisList of herbs Botanical name Action & usesDhataki FlowerMustaMocharasLodhraLata KaranjaWoodfordia Floribunda flowerCyperus scariosus rootBombax malabaricum gumSymplecos recemosus rootCaesalpinia bonduc seedStimulant Astringent and Tonic used inleukorrhea, mennorhagiaPungent, Bitter, Astringent with Carminative,antibacterial, antifungal and Stimulatingproperties used in treatment of inflammation,tumor and infectionAstringent, tonic, demulcent, contains tannicacid and gallic acid. Used in dysentery,leukorrhea and menorrhagiaAstringent used in wound healing to reduce thebleeding, swelling and leukorrheaAntiseptic, Anti parasitic and Cleansing actionused in treatment of pain and skin diseasesTable -2: Formula of the soft gel capsules * .IngredientsExt. Dhataki FlowerExt MustaExt. MocharasPulv.LodhraPulv. Lata KaranjaGheeTotal weight of each capsuleQuantity/capsuleeq. to 20mgeq.to 40mgeq. to 22.5mg100mg50mgq.s650mg* Poly herbal formula code : (WH 1)Fig.1: Age distribution of patients in the study populationAge distribution of patients (yrs)41-5010%51-605%= 203%21-3038%= 2021-3031-4041-5051-6031-4044%71

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Fig.2: Duration of complaints reported by the patients.Duration of complaintsUNKNOWN32%> 1 year22%< 1 month10%1-6 month24%7-12 month12%< 1 month1-6 month7-12 month> 1 yearUNKNOWNFig.3: Number of medication courses given to the patients for the treatment of vaginitis.Number of course of treatment504041No.of patients30201092 2No. of Patients01 2 3 472

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Fig.4: Conditions diagnosed in the patients included in this studyDiagnosis of patients2%2%2%Vaginal Candidiasis13%TrichomoniasisVaginal CandidiasisBacterial Vaginosis33%Non specific VaginitisBacterial VaginosisAtropic VaginitisSenile VaginitisNon specificVaginitis48%Fig.5: Outcome of therapy using a polyherbal formulation (WH 1) in vaginitis30Therapy Outcome302518No.of patients2015106450Improved Not Improved Failed tofollow upExluded fromstudy73

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009clinical study throws up a gamut of questions regarding vaginitis and bacterial vaginosis: a systematicthe specificity and sensitivity to each type of infection. review. Obstet Gynecol Surv 2003; 58(5):351-358.Probably sensitivity and cultural studies may throw more 12. Neri A, Rabinerson , Kaplan B. Bacterial vaginosis:light on the subject. Our observations are similar to some drugs versus alternative treatment. Obstet Gynecol(15,16, 17)of the trials published earlier. In conclusion, the Surv 1994; 49(12):809-813.13. Available from:URL:www.holisticonline.com/results of this study were found to be significant. Thus,Herbal-Med/-Herbs/h143.htm.this study will be extended in larger number of patients in14. Loknath S, Shirpa A. Aetiopathological andfuture.therapeutic study on shleshmaja yonivyapada w.s.r.ACKNOWLEDGMENTWe thank the Heads of Sri Sai Charitable Dispensary, to infective vaginitis. Suchitr Ayurved 2006; 49-55.15. Renuka K, Nandita K, Vinita S, Vanita R, Urmila T,Bangalore and Shreyas Polyclinic, Bangalore for theirSharadini D. Clinical evaluation of PD-959 vaginalhelp in this clinical study. We are thankful to the Principalgel: An open trial. The Antiseptic; 97(11): 400-401.and management of Al-Ameen College of Pharmacy for16. Umadevi K, Swarup Asha. Efficacy of PD 959 gel intheir support. We also thank Dr. V. R. Bapat forabnormal vaginal discharge. Asian J. Obstet.suggesting the formulation, free supply of the PolyherbalGynecol. Practice 1999; 3(1): 68 .capsules (WH1) and for sponsoring this clinical study. 17. Narmada B. Efficacy of V-gel in Vaginitis. Obstet &REFERENCESGynecol 1999; 4(2): 111.1. Available from: URL:www.idph.state.il.us/public/hb/hbvaginitis.htm.2. Available from: URL:http://www.pdrhealth.com/patient_education /BHG01ID05.shtml .3. Allsworth JE, Peipert JF. Prevalence of bacterialvaginosis: 2001-2004 National Health and NutritionExamination Survey data. Obstet Gynecol 2007;109(1):114-120.4. Mitra SK, Sunitha A, Kumar VV, Pooranesan R,Satyarup S. Multicentric trial on the effect of PD-959gel in vaginitis. The Indian Practitioner 1997; 50(11):951-954 .5. Friedrich EG. Vaginitis, Am.J.Obstet & Gynaecol1985; 152; 247.6. Tierney LM, McPhee SJ, Papadakis MA. Currentthmedical diagnosis & treatment. 45 ed. 2006; Lange:731-733.7. Bluestein D, Rutledge C, Lumsden L. Predicting theoccurrence of antibiotic-induced candidal vaginitis(AICV). Fam. Pract. Res. J 1991; 11:319-326.8. Chapple A, Hassell K, Nicolson M, Cantrill J. Youdon't really feel you can function normally: women'sperceptions and personal management of vaginalthrush. J. Reprod. Infant Psychol 2000; 18:309-319.9. Pirotta MV, Garland SM. Genital Candida speciesdetected in samples from women in Melbourne,Australia, before and after treatment with antibiotics.J Clin Microbiol 2006; 44(9):3213-3217.10.Boskey ER. Alternative therapies for bacterialvaginosis: a literature review and acceptabilitysurvey. Altern Ther Health Med 2005 Oct;11(5):38-43.11. Van KK, Assefi N, Marrazzo J, Eckert L. Commoncomplementary and alternative therapies for yeast74

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIINTRODUCTIONHome Medication Review is a concept where a likely to be present. A number of factors are believed topharmacist has the opportunity to visit a patient in the increase the risk of drug related problems in the elderly,familiar surroundings of the latter's home and questions including suboptimal prescribing (e.g. overuse ofthat no one has been able to confidently answer can be medications or polypharmacy, inappropriate use, andanswered. Medication review takes the pharmacist out of under use), medication errors (both by dispensing andthe shop into the community. Home medication review is administration problems) and patient medication, nonanexciting opportunity for Indian pharmacist to adherence (both intentional and unintentional) [2].contribute further to the health care of their communities. A number of studies have investigated medications andThe human body is in a state of change as the years go by. [3,4]medication-related risk factors in patients' homesThere is a progressive functional decline in many organ however,the medication-related problems found in thosesystems with advancing age. Age-associated physiologic studies werenot linked to patients health outcomes.changes may cause reduction in functional reserve Other studies have sought to investigate the relationshipscapacity (i.e. the ability to respond physiologic between a limited number of medication-related riskchallenges or stresses). The cardiovascular, factors that might be identified by a home visit andmusculoskeletal and central nervous system appears to adverse health outcomes. Hospital admission secondarybe most affected. The elderly have multiple and often to adverse drug reactions was found to be related to thechronic diseases. It is not surprising therefore that they use of two or more pharmacies, while drug side effects[1].are the major consumers of drugs There has been a were reported as the reason for non-adherence in 35% ofsteady increase in the number of elderly people, defined patients whose admission was related to non-adherence [5].as those over 65 years of age. Several conditions are Non-adherence also precipitated about 5% of hospitalreadmissions in geriatric patients previously dischargedon three or more drugs prescribed for chronicIndian Journal of Pharmacy PracticeReceived on 03/02/2009 Modified on 13/02/2009Accepted on 17/03/2009 © APTI All rights reservedijoppPrevalence of Diseases and Observation of Drug Utilization Patternin Geriatric Patients: A Home Medication Review1 2 3Pandey Awanish ,Tripathi Poonam ,Pandey Rishabh DevM.Pharm, Institute of technology and Management, GorakhpurAddress for correspondence: awanishpandey@rediffmail.comAbstractGeriatric patients may have medication-related risk factors only identified by home visits, but the extent to whichthoserisk factors are associated with poor health outcomes remainsunclear. To observe the drug utilization patternand prevalence of chronic diseases in elderly by visiting them in their community. A door-to-door survey wasconducted in an area of 2 sq. km surrounding Shri Mahant Indiresh Hospital of Dehradun, to identify geriatricresidents, diseases prevalent in them and prescription pattern. The study was primarily targeted at the elderlybecause, as a group they take more drugs than their younger counterparts and are known to be at risk of the sideeffects of many of the drugs they consume. The result of this study showed that 34 % geriatric patients were sufferingfrom cardiac disorder while 22% from diabetes and 18% from osteoarthritis among elderly population. 40%patients were non-compliant due to poor economic status, difficulty in swallowing of the prescribed dosage forms,and disturbing side effects. Self-medication (38%) was a prevalent phenomenon among the elderly. The studyconclude that cardiac disorders, diabetes and rheumatism were the most prevalent diseases and self-medicationwas the prevalent phenomenon responsible for the adverse drug reactions in geriatric patients. The study suggeststhat elderly patient education through home medication review can significantly improve patient knowledge andcompliance with medication.Keywords: Home medication review, Noncompliance, Selfmedication, Geriatrics, Polypharmacy[6].conditions Similarly, poor adherence was associated75

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009with increased risk of adverse drugevents (ADEs) in the prescribed to the elderly patients (Table-2), out of which[7],elderly and hospital admission due to drug-related Antihypertensive drugs (31%), Anti-diabetic drugsproblems can result in patient morbidity, mortality and (22%), Antiplatelet agents (16%), Anti-rheumatic drugs[8].increased health costs It is possible that other (24%), Bronchodilators (7%), Hypolipidemic drugsmedication-related risk factors identified at home visits (2%), Anti-tubercular drugs (1%), and drugs acting oncould be associated with poor health outcomes, but Thyroid gland (1%) were prescribed. This survey alsothese medication-related risk factors have not, to date, revealed that 38% of the elderly does self-medication,been extensively studied.out of which 32% take allopathic medicines and 6% takeThis study has been conducted to observe the drug Ayurvedic and homeopathic medicines. Reasons for selfutilizationpattern and prevalence of chronic diseases in medication are listed in Table-3. Drugs likeelderly by visiting them in their community.Multivitamins, Iron and Calcium supplements wereMETHODOLOGYtaken by the elderly as Over the Counter preparationA Door to door survey was conducted to identify the(Table-4). Analgesics and Antipyretics were commonlyresidents of age 65 years and above from May 2008 totaken by the elderly for self medication (Table-5).July 2008. 100 subjects were included for the study DISCUSSIONafter informing them about the purpose of the study and The results from present study demonstrate that cardiacprior consent. A questionnaire was prepared, many disorders, diabetes and rheumatism were the mostpractical questions regarding diseases, medication prevalent diseases in geriatric patients of consideredprescribed, health status involving socioeconomic area. This study suggests that Difficulty in swallowing[9].status, family support, were included The geriatric tablets and economic factors are the majorly responsiblesubjects were quite cooperative and confident in for non-compliance of geriatric patients so alternativeanswering the questions since it was their familiar dosages form other than tablet may enhance thesurrounding i.e. home. Table-1 shows the questions, compliance of the geriatric patients and economic factorwhich were asked during medication review of elderly should be considered by general practitioners at the timepatients. Questionnaire was analyzed by using SPSS of prescribing. In our study, we found that self-Microsoft Excel.medication was the prevalent phenomenon for drugs,INCLUSION CRITERIAwhich may be responsible for the adverse drug reactionsPatients were included in this study if they satisfied oneof drugs in geriatric patients. The study provides someor more of the following criteria: (i) on five or moreindication that the home medication review by a trainedregularmedications; (ii) taking twelve or more doses ofpharmacist may help to rationalize prescribing by generalmedication per day; (iii) three or more medicalpractioners. The study also suggests that elderly patientconditions; (iv) suspected to be non-adherent with theireducation through home medication review canmedication regimen (v)on medication(s) with a narrowsignificantly improve patient knowledge and compliancetherapeutic index or requiring therapeutic monitoring;with medication. The teamwork of general practioners(vi) had significant changes made to their medicationand pharmacist is needed. The public health system needsregimen in the previous three months; (vii) had signs ormore specialists in this field. “We cannot heal the oldsymptoms suggestive of possible medication inducedage, but let us protect it, promote it and prolong it,”Sir Jproblems; (viii) had an inadequate response to [9]Rosmedication treatment; (ix) admitted to hospital inTable 1 – Questionnairepreceding four weeks; (x) at riskin managing their ownmedications due to language difficulties, dexterityQuestions were asked regardingproblems or impaired sight.? 1. Disease of patient and medicines prescribed.RESULTSThis community based survey included 100 elderly ? 2. Patient compliance for medication. If no, then reason.patient.49% was males and 51% was females. Fig1? 3.Any other medications (ayurvedic, allopathic, homeopathic)shows prevelance of numerous chronic disorders inconcerned elderly population. The reasons for noncompliancetaken by the patient which neither pharmacist nor doctor knew.are shown in Fig 2.Difficulty in swallowingtablets (24%) was the most common cause of patient? 4. Risks associated with the structure of house and furnishing(such as poor lightning, stairs obstacles etc).non-compliance. A Total of 120 individual drugs were76

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table-2 Classification of drugs prescribed to the elderly.Table 3-Reasons for Self-medicationS.N REASONS %PATIENTS %MALE %FEMALE1.Lack of time23%15%8%2.High consultation fee29%14%15%3.Quick relief18%18%0%4.Believes in Ayurveda16%3%13%5.Family members are not supportive5%0%5%6.Unable to walk9%0%9%77

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Table 4 -Over the counter drugs used by the elderlyS.N DRUGS DOSE DOSAGE FORM1.Becosule(vit.B complex)500mg o.dCapsule2.Evion(vit.E)500mg o.dCapsule3.Dexorange(iron prep.)50ml 2tsf b.dSyrup4.Benadon(pyridoxine)40mg o.dTablet5.Supracal(calcium citrate+magnesium hydroxide)100mg b.dTablet6.Solbala plus(Methylcobalamine+lipoic acid)10 mg b.dCapsuleTable 5 - Drugs taken by the elderly as Self-medication78

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Fig-1 Prevalence of chronic disorders among elderlyO steoarthritis18%C.N .Sdisorders6%Cardiacdisorders34%D iabetes22%G .I.disorders4%M iscellaneousdisorders6%Resp iratorydisorders10%Fig.2 Reasons for non-compliance among elderlyB elieves in homeremedies8%Family membersare notsupportive8%Forget to taketheir medicines20%Side effects ofthe drug20%Faces difficulty inswallowing24%D ue to pooreconomic status20%REFERENCESreactions in hospitalizations of the elderly. Arch1. Walker R, Edwards C. Clinical Pharmacy and Intern Med 1990; 150:841–845.Therapeutics. Edinburgh: 2003; Churchill6. Bero LA, Lipton HL, Bird JA. Characterization ofLivingstone:127-139.geriatric drug-related hospital readmissions. Med2. Medication for Elderly- A Report of the Royal Care 1991; 29:989–1003.college of Physician. 1984;18:7-17.7. Hsia Der E, Rubenstein LZ, Choy GS. The benefits3 Beech E, Brackley K. Medicines management. Part- of in-home pharmacy evaluation for older persons. J1. Domiciliary based medication for the elderly. Am Geriatr Soc 1997; 45:211–214.Pharm J 1996; 256:620–622.8. Van den Bemt PM . Drug-related problems in4 Read RW, Krska J. Targeted medication review: hospitalized patients. Drug Saf 2000; 22:321–333.patients in the community with chronic pain. Int J 9 Meisheri YV. Geriatric Services-need of the hour. JPharm Prac 1998; 6:216–222.post:103-105.5. Col N, Fanale JE, Kronholm P. The role ofmedication noncompliance and adverse drug79

Indian J. Pharm. Pract. 1(2), Jan-Mar, 200910. World Health Organisation. (WHO) 1997, the role of 15. Unwin N. Commentary: Non-communicablethe pharmacist in the health care system: Preparing disease and priorities for health policy in subthefuture pharmacist: Curricular development. Saharan Africa. Health Policy Plan. 2001; 4:351-Vancouver, Canada, 27-29 August 1997. 352.W H O / P H A R M / 9 7 / 5 9 9 . [ I n t e r n e t ] 16. Lee JK, Grace KA, Taylor AJ. Effect of a PharmacyAvailable:http://www,whqlibdoc.who.int/hq/1997/ Care Program on Medication Adherence andWHO_PHAR M_97_599.pdf [Accesed 06/09/08]Persistence, Blood Pressure, and Low-Density11. Accreditation Council for Pharmacy Education.Lipoprotein Cholesterol. JAMA. 2006; 296: 2563-2006, Accreditation Standards and Guidelines for2571.the Professional Program in Pharmacy Leading to 17. Downer SR, Meara JG, John G, Da Costa AC. Usethe Doctor of Pharmacy Degree. [internet] Availableof SMS text messaging to improve outpatienthttp://www.acpeccredit.org/pdf/ACPE_Revised_attendance. Med J Aust. 2005; 183(7): 366-368.PharmD_Standards_Adopted_Jan152006.pdf 18. Biem HJ, Turnell RW, D'Arcy C. Computer[Accessed6/09/08]telephony: automated calls for medical care. Clin12. World Health Organisation. Regional Office forInvest Med . 2003 Oct; 26(5):259-68.Africa (WHO/AFRO) 2002, A special health19. Horne R, Weinman J. Patients' beliefs aboutpromotion project: The health promotions initiative.prescribed medicines and their role in adherence to[Internet]. Updated 24 October 2002.treatment in chronic illness. J Psychosom Res. 1999;[Internet]Available:http://afro.who.int/healthpromo47(6):555-567.tion/project.html [Accessed 06/09/08]13. World Health Organisation. (WHO) 2007, The20. Treweek S. Joining the mobile revolution. Scand J ofBangkok Charter for Health Promotion in the Pri Health Care. 2003 June; 21(2): 75-76.21. Many patients willing to pay for onlineGlobalized World. Health Promotion International.2006; 21:10-14.communication with their physician. [internet]14. Anderson C. Health promotion in community Available:http://www.harrisinteractive.com/news/apharmacy: the UK situation, Patient educ couns.2000; 39:285-291.llnewsbydate.asp?NewsID=446.[Last accessed06/09/08]80

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009APTIijoppL-ASPARAGINASE INDUCED CENTRAL VENOUS THROMBOSIS IN ACUTELYMPHOBLASTIC LEUKEMIA1 2 1 1 1Lavanya S , Vijayan K , Abhay Dharamsi , Rajasekaran A Vijayakumar A1,3 .1. Drug and Poison information Center, Department of Pharmacy Practice,KMCH College of Pharmacy,Kalapatti road, Kovai Estate, Coimbatore - 6410482. Consultant, Department of Neurology, Kovai Medical Center and Hospital, Coimbatore- 641014Address for Correspondence: vijayspharm@gmail.comBackgroundTo report a case of central venous thrombosis following treatment of acute lymphoblastic leukemia withL-asparaginase. A 13-year-old master presented with an acute lymphoblastic leukemia associated with threeepisodes of focal onset convulsions with secondary generalization, headache and altered sensorium. He was2 2initially treated with 5000 u/m of L-asparaginase followed by 10,000 u/m every third day for 4 weeks. After aweek’s course of L-Asparaginase, the patient experienced central venous thrombosis. MRI showed thrombosis ofthe sagittal, transverse and straight sinuses on the right side with partial recanalisation, suggesting a drug inducedneurotoxic reaction. According to the Naranjo probability scale, the central venous thrombosis was probablycaused by L-Asparaginase. L-Asparaginase-induced central venous thrombosis is rarely reported shortly afterbeginning L-asparaginase therapy in patientswith acute lymphoblastic leukemia. However, bleeding or thrombosisoccurring as a direct result of changes in coagulation factors has not been frequently reported. The purpose is toevaluate the current knowledge of central venous thrombosis in association with ALL in children. Health careprofessionals should be aware of this potential adverse reaction and monitor the patients regularly duringL-asparaginase therapy.Key Words: L-asparaginase, Central Venous Thrombosis, Acute Lymphoblastic Leukemia.INTRODUCTIONCASE REPORTAcute lymphoblastic leukemia (ALL) is more frequent in A 13-year-old boy was presented to Kovai Medicalchildren than in adults; indeed, two thirds of all cases Center and Hospital, India in January 2005, with1occur at pediatric age . The risk of thrombosis is complaints of three episodes of focal onset convulsionsincreased in ALL patients, and its occurrence maywith secondary generalization. History revealed headcomplicate the treatment course with a negativeturning to left follow by generalized tonic-clonic2prognostic impact . L-asparaginase hydrolyses L-convulsions. Hemoglobin was 10.6 g/dl, leukocytes 1700asparagine which is a non essential aminoacid. L-cells/cumm, and the platelet count 1, 07,700 cells/cumm.asparaginase is used particularly in acute lymphoblasticThe differential count revealed 16% lymphocytes, 81%leukemia (ALL) and in other hematologicalmalignancies such as acute myeloblastic leukemianeutrophils, and 3% monocytes. The patient's bone(3,4)(AML) and lymphoma . Therapy has been associated marrow aspiration showed 90% blasts (L1 typewith various forms of toxicity, including according to French-American-British (FAB)hypersensitivity, coagulation abnormalities and classification) with Periodic acid Schiff reaction (PAS),(5,6)others . L-asparaginase shows this effect by decreasing sudan Black and myeloperoxidase stains negative. The(7,8)the synthesis of coagulation proteins . In literature, patient was on prednisolone, vincristine, daunorubicin, l-thrombosis is emphasized more than hemorrhagic asparaginase, methotrexate and cytosine. Computedcomplications due to L-asparaginase. This report Tomography (computerized type of x-ray that gives verydescribes a case who developed central venous detailed images of internal organs such as the brain) scanthrombosis confirmed by Magnetic Resonance Imagingof the brain was normal but during the next 48 hours, he(MRI) during L-asparaginase therapy.developed weakness of the left upper limb.The prothrombin time was 29 seconds, the partialIndian Journal of Pharmacy PracticeReceived on 12/01/2009 Modified on 11/02/2009thromboplastin time 48 seconds fibrinogen, protein C,Accepted on 24/02/2009 © APTI All rights reservedprotein S, antithrombin III levels were normal. Serum81

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009ammonia was 443 ìg /dl (normal value 25-94 ìg/dl). L- normal coagulation factors-especially fibrinogen-andasparaginase toxicity was suspected. Throat swab and thrombotic cases developing by decreased Antithrombinurine cultures were negative. As cerebral venous sinus III (AT Ill) and Plasminogen or decreased fibrinogenthrombosis was suspected a MRI and Magnetic level and hemorrhagic cases developing by normal AT IIIResonance Venography (MRV) of the brain were done,(9,10)and plasminogen concentration .which revealed thrombosis of the sagittal, transverse AI-Mondhiry reported that, in two of the four patientsand straight sinuses on the right side with partial whom vincristine and prednisone treatment applied,recanalisation. Low dose subcutaneous heparin 2500 fibrinogen level decreased but Prothrombin time (PT),thI.U 8 hourly was started and continued for 10 days. The Partial thromboplastin time (PTT) and Thrombin timepatient regained normal power in the left upper limb and(11)(TT) remain in normal limits . Ramsay et al useddid not have any further convulsions. Acetyl salicylic vincristine, prednisone, and L- asparaginase in 26 ALLacid 150 mg/day orally was given for 7 to 10 days and cases. In these cases, after cessation of L-asparaginasethe patient was discharged.coagulation tests were turned to normal limits.Anterioposterior (AP) view of MRV showing absenceConsequently those coagulation abnormality were foundof filling of sagittal sinus and right transverse and (12)to be due to L-asparaginase .sigmoid sinuses is shown in picture 1. Lateral view of In the study of Miniero et al., when the patients are treatedMRV showing venous filling defects as noted above are by prednisone, vincristine and L-asparaginase, comparedshown in picture 2.with patients treated by only L-asparaginase moreDISCUSSION(13)L-asparaginase enzyme has a molecular weight ofcommon coagulopathy was observed . In the133.000 daltons and hydrolyses L- asparagine. L-previously treated ALL cases, some hemorrhagic andasparagine is synthesised by transamination of L- thrombotic complications due to L-asparaginase have(14,15,16,17)aspartic acid. In tumor cells, lacking of L-asparagine been reported .synthase, the L-asparagine can be obtained from theHemorrhagic complications due to L-asparaginase arecirculating pool of amino acids. As the L-asparaginaseseen rarely and important for morbidity, once in 2 or 3will decrease the amount of extracellular L-asparagine,days the coagulation parameters (PT,PTT, Fibrinogen,tumor cells use this amino acid which is necessary forPlasminogen,and AT III levels) must be measured andprotein synthesis. But in normal cells, this synthesis when necessary, fresh frozen plasma, AT III andmay be re-done because of enzyme existence.thrombolytic therapy must be given. However, bleedingCerebrovascular symptoms dependent on or thrombosis occurring as a direct result of changes inL-asparaginase appear in two forms; either increased or(18)coagulation factors has not been frequently reported .Table No 1: Treatment Schedule for Induction TherapyVariables Mg/m2 Dayvincristin 1.5 8,15,22,29prednisolone 60 1-28daunorubicin 30 8,15,22,29L-asparaginase 10,000 19,22,25,28,31,34,37,40methotrexate BY AGE 182

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009Figure no.1: AP view of MR Venogram showing absence of filling of Sagittal sinus andright transverse and sigmoid sinuses.Figure no.2: Lateral view of MR venogram showing venous filling defects as noted above.83

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009CONCLUSIONL-asparaginase studies of fibrinogen survival usingTreatment related to thrombotic complications during autologus 1-131fibrinogen. Blood 1970; 35:195-the induction therapy and recent evidence indicates that 200.concomitant administration of L-asparaginase is likely 8. Peterson RC, Handschumacher RF, Mitchell MS.to be associated with higher incidence of central venous Immunological responses to Lasparaginase. J Clinthrombosis, especially in children with atleast one Invest 1971; 50:1080-1090.prothrombotic risk factor. This result in prolongation of 9. Gugliotta L, Augelo A, Mattioli-Belmonte M,the prothrombin time (PT), activated partial Vigano-O'Angelo S, Colombo G, Catoni L, et al.thromboplastin time (aPTT) and hypofibrinogenimia. Hypercoagulability during L-asparaginaseThese coagulation abnormalities resolve within 1-2 treatment the effect of antithrombin IIIweeks after cessation of the drug.supplemantation in vivo. Br J Haematol 1990; 74At present, there is no general agreement on the need to (4):465-470.monitor the coagulation/fibrinolytic systems in patients 10. Kingma A, Tammnga RY, Kamps WA, Le-ceultre R,treated with L-asparaginase. There are also no Saan RJ. Cerebrovascular complications ofguidelines on ways to avoid either the haemorrhagic or L-asparaginase therapy in children with leukemia:the thrombotic complications. It is suggested to replace aphasia andother neuropsychological deficits.the coagulation factors with fresh frozen plasma and at Pediatr Hematol Onco1 1990; 10(4):303-309.the same time, give AT III and heparin; but the 11. AI-Mondhiry H. Hypofibrinogenemia associatedconsensus is to treat expectantly.with vincristine and prednisone therapy inACKNOWLEDGMENT lymphoblastic leukemia. Cancer 1975; 35:144-147The authors are thankful to Dr.Nalla G Palaniswami, 12. Ramsay NKC, Coccia PF, Krivit W, Nesbit ME,Chairman and Managing Director of Kovai Medical Edson JR. The effect of Lasparaginase on plasmaCenter and Hospital, Coimbatore and Dr.Thavamani D coagulation in acute lymphoblastic leukemia.Palaniswami, Trustee, Kovai Medical Center ResearchCancer 1977; 40:1398-1401.and Educational Trust, Coimbatore for providing 13. Kucuk 0, Kwaan HC, Gunnar W, Vazguez M.necessary facilities and continuous encouragement. Thromboembolic complications associated with L-REFERENCESasparaginase therapy. Cancer 1985; 55:702-706.1. Redaelli A, Laskin BL, Stephens JM, Botteman14. Priest JR, Ramsay NKC, Latcham RE, Lockman LA,MF, Pashos CL. A systematic literature review ofHasegawa DK, Coetes TD. Thrombotic andthe clinical and epidemiological burden of acutehemorrhagic strokes complicating early therapy forlymphoblastic leukaemia. Europ J Cancer Carechildhood acute lymphoblastic leukemia. Cancer2005; 14:53-62.1980; 46:1548-1554.2. Athale UH, Chan AKC. Thrombosis in children15. Priest JR, Ramsay NKC, Stemtarz PG, Tubergen DG,with acute lymphoblastic leukaemia:Cairo MS, Sitarz AL, etal. A syndrome of thrombosisepidemiology of thrombosis in children with acuteand hemorrhage complicating L-asparaginaselymphoblastic leukaemia. Thrombosis Res 2003;therapy for childhood acute lymphoblastic111:125-131.3. Capizzi RL, Bertmo JR, Handschumacher RE.leukemia. J Pediatr 1982; 100:984-989.16. Cairo MS, Lazarus K, Gilmare RL, Bachrur RL.L-asparaginase. Ann Rev Med 1970; 21:433.4. Keating MJ, Holmes R, Levuar S, Ho OH.Intracranial hemorrhage and focal seizuresL-asparaginase and PEG asparaginase past,secondary to use of L-asparaginase during inductionpresent, and future. Leuk lymphoma 1993; 10:153-therapy of acute lymphocytic leukemia. J Pediatr157.1980; 97:829-833.5. Haskell CM, Canellos GP, Leventhal BG, Carbore 17. Parma M, Belotti D, Pogliani-EM. Management ofPP, Block JP, Serpick AA, et al. L-asparaginase L-asparaginase induced prothrombotic state in acutetherapuetic and toxic effect in patient with lymphoblastic leukemia. Haematologica 1996;neoplastic disease. N Engl J Med 1969; 281:1028- 81(2):191.18. Celeste Lindley. Adverse effects of chemotherapy.1034.6. Oettgen HF, Stephanson PA, Schwatz ML, Leopar In: Koda-Kimble Mary Anne , Yee Young Lloyd ,RO, Fallal KR, Tan CC. Toxicity of Ecoli Kradjan Wayne A, Guglielmo Joseph B, AlldredgeL-asparaginase in man. Cancer 1970;25:153-278.Brian K, Corelli Robin L. Applied therapeutics: The7. Peterson RE, Himelstein ES, Oettgen HF and clinical use of drugs. Philadelphia: 2005; LippincottClifford GO. Hypofibrinogenemia due to Will ia ms & Wi lk ins:89- 95.84

Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009INSTRUCTIONS TO AUTHORS -2009INDIAN JOURNAL OF PHARMACY PRACTICE (ijopp)Indian Journal of Pharmacy Practice (ijopp) is official numbered consecutively with arabic numbers, beginningjournal of Association of Pharmaceutical Teachers of with title page, ending with the (last) page of figureIndia (APTI). Indian Journal of Pharmacy Practice, a legends. The length of an Review/ Science Educationquarterly publication is devoted to publishing reviews article should not exceed 25 manuscript pages to includeand research articles in the area of Pharmacy Practice. figures, tables and references. No abbreviations orArticles in the areas of clinical pharmacy, hospital acronyms shall be used in the Title or Abstract acronyms,pharmacy, community pharmacy, pharmaceutical care, except for measurements. All the references, figurespharmacovigilance, pharmacoeconomics, clinical (Fig.) and tables (Table) in the text shall be numberedresearch, clinical pharmacokinetics and other related consecutively as they first appear. No sentence shall startissues can be sent for publication in ijopp. All with a numeral. Abbreviations like “&” and “etc” shall bemanuscripts should be submitted in triplicate along with avoided in the paper. There shall not be any decorative'Authorship Responsibility Undertaking', signed by all borders anywhere in the text including the title page. Thethe authors of the paper to,entire MS Word document with graphs and illustrationsThe Editor,pasted in it shall not exceed 2 MB. Manuscripts mustIndian Journal of Pharmacy Practice,Association of Pharmaceutical Teachers of India, conform to the “Uniform Requirements for ManuscriptsH.Q.: Al-Ameen College of Pharmacy, Hosur Road, Submitted to Biomedical Journals” http://www.icmje.org/.Opp. Lalbagh Main Gate, Bangalore- 560 027.The Content of the manuscript shall be organized in theAuthors should retain a copy of all materials submitted to following sequence and shall start on separate pages: titlethe journal; the editor cannot accept responsibility for page (including author's name, affiliations and addressloss or damage to submitted materials.for correspondence), abstract (including atleast 4 keyManuscripts will be subjected to peer review process to words), text (consisting of introduction, materials anddetermine their suitability for publication, provided they methods, results, discussion, conclusion andfulfilled the requirements of the journal. After the review, acknowledgements), references, figure legends, tablesmanuscript will be returned for revision along with and figures. Titles should be short, specific, and clear.reviewer's and /or editor's comments. One original copy Beginning with the first page of text, each page should beof the final revised manuscript should be submitted for consecutively numbered.publication within one month after receiving the For the Review Articles, the author(s) is absolutely freecomments. It is also desirable to submit the final revised to design the paper. The Abstract section is needed formanuscript on a CD prepared in MS word version 6.0/95 review articles too. The article should not exceed 15or a higher version.manuscript pages including figures, tables andSubmission of a manuscript to ijopp for publicationreferences. References, figures, and legends shall followimplies that the same work has not been eitherthe general guidelines described below. For all otherpublished or under consideration for publication inArticles, the following format shall be strictlyanother journal.followed.Author/s publishing results from in-vivo experimentsTitle Page. The following information should appear:involving animal or humans should state whether duetitle of article (A running title or short title of not morepermission for conduct of these experiments wasthan 50 characters), authors' name, and last name. Theobtained from the relevant authorities /Ethicsauthor to whom all correspondence be addressed shouldcommittee/Institutional Review Board.Manuscript preparation:be denoted by an asterisk mark. Full mailing address withManuscripts should be concisely typewritten in double pin-code numbers, phone and fax numbers, andspace in A4 sized sheets, only on one side with a 2 cm functional e-mail address should be provided of themargin on all sides. The manuscript shall be prepared in author for correspondence. Names of the authors shouldTimes New Roman font using a font size of 12. Title appear as initials followed by surnames for men and oneshall be in a font size 14. All section titles in the given-name followed by surname for women. Full namesmanuscript shall be in font size 12, bold face capitals. may be given in some instances to avoid confusion.Subtitles in each section shall be in font size 12, bold face Names should not be prefixed or suffixed by titles orlower case followed by a colon. The pages shall be degrees.85

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Indian J. Pharm. Pract. 1(2), Jan-Mar, 2009PatentIndian Journal of Pharmaceutical Sciences- (Indian JLarsen CE, Trip R, Johnson CR, inventors; NovostePharm Sci)Corporation, assignee. Methods for procedures related to Journal of the American Chemical Society, The- (J Amerthe electrophysiology of the heart. US patent 5529 067.Chem Soc)1995 Jun 25.Journal of Biological Chemistry- (J Biol Chem)Chapter or article in a bookFormat: Author(s) of chapter (surname initials). Title ofJournal of Organic Chemistry, The- (J Org Chem)chapter. In: Editor(s) name, editors. Title of book. PlaceJournal of Pharmacology and Experimentalof publication: Publisher; Year of publication. page Therapeutics- (J Pharmacol Exp Ther)numbers.New England Journal of Medicine- (N Engl J Med)Electronic journal articlePharmaceutical Journal, The (Pharm J)Morse SS. Factors in the emergence of infectious PharmacologicalResearch Communicationsdiseases.Emerg Infec Dis [serial online] 1995Jan-Mar (Pharmacol Res Commun)[cited 1996 Jun 5];1(1):[24 screens]. Available from: AUTHOR's CHECKLIST FOR SENDING PROOFSURL: http://www.cdc.gov/ ncidod/EID/eid.htmTO EDITORIAL OFFICEWorld Wide WebIn order to maintain quality and consistency in IndianFormat: Author/editor (surname initials). Title [online].Year [cited year month day]. Available from: URL:Journal of Pharmacy Practice, we ask you to perform theWorld Wide Web page McCook A. Pre-diabetic following items prior to submitting your final proof forCondition Linked to Memory Loss [online]. 2003 [cited publication:2 0 0 3 F e b 7 ] . A v a i l a b l e f r o m : U R L : Include the original, hard copy of Author'shttp://www.nlm.nih.gov/medlineplus/news/fullstory_ Transfer of Copyright signed by each author11531.htmlThoroughly check the article for typographic errors,Abbreviations for Journals For More information onmedline indexed journals : Download list of medlineformat errors, grammatical errors, in particular:journals: ftp://ftp.ncbi.nih.gov/pubmed/J_Medline.zip spelling of names, affiliations, any symbols,American Journal of Pharmacy- (Amer J Pharm)equations in the context, etc.Analytical Chemistry- (Anal Chem)Provide graphs and figures in excel format, PicturesBritish Journal of Pharmacology and Chemotherapyarerequired as high resolution images (300 dpi).(Brit J Pharmacol)Canadian Journal of Pharmaceutical Sciences- (Can J Provide laser printed hard copies of all figures andPharm Sci)graphics in black and white or scanned copies canClinical Pharmacokinetics- (Clin Pharmacokinet)also be sent to ijopp@rediffmail.comDrug Development and Industrial Pharmacy- (DrugSubmit a proof corrected with RED INK ONLY.Develop Ind Pharm)Helvitica Chimica Acta- (Helv Chim Acta)List out the corrections made in typed format in aIndian Journal of Medical Sciences- (Indian J Med Sci) separate page with 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.com88