Jul-Sep, 2012 - Indian Journal of Pharmacy Practice

Chang J - India's Progress towards the health related Millennium Development Goals – Maternal Health10. Kotecha PV (2009). Maternal Health Services - Quality of Care:Uttar Pradesh Scenario –Anemia Control as a context.Solution Exchange for MCH Community, News Letter Safe –Motherhood special. Available at: ftp://ftp.solutionexchange.net.inpublic/mch/comm_update/res-32-300409-23.pdf.th[accessed on 10 May 2011]11. Wada Na Todo Abhiyan (2007). Measuring India's Progress onthe Millennium Development Goals. A Citizens' Report.Available at: http://www.endpoverty2015.org/en/asianews/india-citizens- report-mdgs-released/07/jan/08.th[accessed on 10 May 2011].13. UNICEF (2008). Tracking progress in maternal, newborn &child survival: the 2008 report. NewYork. Available at:http://www.who.int/pmnch/Countdownto2015FINALREPORTthapr7.pdf. [accessed on16 May 2011].12. Wada Na Todo Abhiyan (2010). Millennium DevelopmentGoals in India,2010- A Civic Society Report. Available at:http://asiapacific.endpoverty2015.org/files/mdgs-reportthfinaal.pdf. [accessed on 20 May 2011].14. UNICEF (2009) Maternal and Perinatal Deaths Inquiry andResponses. India Country Office, New Delhi. Available at:h t t p : / / w w w . u n i c e f . o r g / i n d i a / M A P E D I R -Maternal_and_Perinatal_ Death_Inquiry_and_ResponsethIndia.pdf. [accessed on15 May 2011].15. Lahariya C (2009) Cash incentives for Institutional delivery:Linking with antenatal and post natal care may ensurecontinuum of care in India. Indian Journal of CommunityMedicine 34,15-18.16. Vora KS, Mavalankar DV and Ramani KV et al. (2009)Maternal health situation in India: A case study. Journal ofHealth, Population and Nutrition 27,184-201.17. Kumar S (2010) Reducing maternal mortality in India: Policy,equity, and quality issues.Indian Journal of Public Health54,57-6418. Bakshi Roopa (2006) Maternal Mortality – a woman dies every5 minutes in childbirth in India. Available at:thhttp://www.unicef.org/india/health_1341.htm [accessed 20May 2011].19. Liljestrand J (2000) Strategies to reduce maternal mortalityworldwide. Current Opinion in Obstetrics and Gynecology12,513-517.20. Registrar General (2006). Maternal Mortality in India: 1997-2003. 2006.21. Registrar General (2009) Special Bulletin on Material Mortalityin India 2004-2006. Sample Registration System. Office of theR e g i s t r a r G e n e r a l , I n d i a . A v a i l a b l e a t :http://www.mp.gov.in/health/MMR-Bulletin-April-2009.pdf.th[accessed on11 May 2011].22. Hazarika I (2010) Factors that Determine the Use of SkilledCare During Delivery in India: Implications for Achievement ofMDG-5 Targets. Maternal and Child Health Journal.Sep 22.[Epub ahead of print]23. Ronsmans C, Graham WJ and Lancet Maternal SurvivalSeries steering group (2006) Maternal mortality: Who, When,Where and Why. Lancet 368,1189-1200.24. Campbell OM, Graham WJ and Lancet Maternal SurvivalSeries steering group (2006) Strategies for reducing maternalmortality: Getting on with what works. Lancet 368,1284-1299.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 4

Ingle P.V - Sociocultural, Healthy Nutrition & Eating, Exercise Pattern and Use of Ayurvedic Medicines in Pregnancy.and sexually transmitted diseases (Particularly prevention ofHIV transmission from mother to child); and tetanus toxoidimmunization. Antenatal care is the opportunity to promotethe benefits of skilled attendance at birth and to encouragewomen to seek the post partum care of themselves and theirnewborns. Antenatal care is the essential link betweenhousehold to hospital care continuum. It is an interventionthat can be provided at both household and peripheral facilitylevels and helps assure the link to higher levels of care when8needed (USAID).Weight gainWoman's weight at the start of pregnancy is one of the mostimportant modifiers of pregnancy weight gain and has impacton a mother's and her baby's health. Body mass index (BMI, ameasure of body fat based on weight and height) is the bestavailable measure of prepregnancy weight, has been updatedin the new guidelines to the categories developed by theWorld Health Organization (WHO) and adopted by theNational Heart, Lung, and Blood Institute (NHLBI) (IOM).Table 1: Recommendation by IOM for total and rate of weightgain during pregnancy, prepregnancy BMIPrepregnancy BMI+ (kg/m2) Total Weight Rates ofBMI (WHO) Gain Range Weight Gain(lbs) 2nd and 3rdTrimester(Mean Rangein lbs/wk)Underweight

Ingle P.V - Sociocultural, Healthy Nutrition & Eating, Exercise Pattern and Use of Ayurvedic Medicines in Pregnancy.12,13the LBW category, the higher is the risk of death.Chronic moderate malnutrition and anaemia duringpregnancy may result in still birth and Low Birth Weight(LBW) babies weighing less than 2500g. A large number ofsuch babies are premature (

Ingle P.V - Sociocultural, Healthy Nutrition & Eating, Exercise Pattern and Use of Ayurvedic Medicines in Pregnancy.Causes of IUGR:Ÿ Diseases of the immune and vascular system:Vascular diseases due to preeclampsia, diabetes mellitus,renal disease or collagen vascular disease are the mostcommon causes of IUGR. Hemodynamic studies Shows thatthe blood supply to the fetoplacental unit is impaired inpreeclampsia and SGA and that physiological changes in thespiral arteries are restricted to the decidual segment in suchcase. Serious essential hypertension (diastolic blood pressure> 110 mm Hg) before 20 weeks gestation increased the risk of10early IUGR and premature delivery.Ÿ Psychological, social factors and working conditions:The IUGR contributing factors were increased psychosocialstressors, susceptibility to infections or smoking, low folateintakes and hyperhomocysteinemia. Low maternal education,thought to be associated with SGA, was not a risk factor when16data were adjusted for smoking.Ÿ Infections:Many types of infections may contribute to IUGR.Helicobacter pylori infections during pregnancy may cause11IUGR. Factors associated with IUGR were short status,primigravida, and malaria at delivery. The risk of IUGR wasparticularly associated with maternal malnutrition inprimigravidae. From a global view malaria is a frequentavoidable cause of IUGR. Toxoplasmosis and syphilis are17also associated with IUGR.Ÿ Twin delivery:In twin pregnancies 15-30% was associated with IUGR and18premature delivery . Monochorial twin pregnancies withintra-placental anastomoses may permit twin to twintransfusion and thus lead to a twin-twin transfusion syndrome(TTTS). In TTTS pregnancies leptin levels in recipient twinswere three times higher than in IUGR donor twins, whereas intwin pregnancies with one IUGR twin, but without TTTS, the19leptin differences were only 2-fold.Ÿ Drug side effects:The use of the beta blocker atenolol at conception and duringearly pregnancy, but not during the second or third trimester,may cause IUGR. It has also been assumed that antiepilepticdrugs may inhibit fetal growth. Corticosteroids are used totreat systemic lupus erythematosus (SLE), chronic regionalenterocolitis and ulcerative colitis during pregnancy and inhigh doses may cause IUGR. Warfarin treatment duringpregnancy may lead to miscarriage, microencephalia,20blindness, prematurity and IUGR.Ÿ Umbilical cord anomalies:Pregnancies with one umbilical artery may be associated withchromosome defects, fetal anomalies, IUGR and increasedfetal mortality. Both hypo-and hypercoiled cords may causereduced umbilical blood flow, decreased placental blood flow4and consequently IUGR.Ÿ IUGR and post term delivery:From many evidences it is found that relationship betweenIUGR and pubertal development indicating changes in timingand progression of puberty. These changes are part of agrowing list of IUG related diseases which includes short4stature and polycystic ovary.Ÿ Fetal and neonatal consequences of IUGR:IUGR is associated with fetal hypoxia, hypoglycemia,aspiration of meconium and neonatal respiratory problemsand central nervous disturbances (CNS) such asintraventricular hemorrhage, periventricular leukomalacia21,22and cerebral infarctions.Healthy eating in pregnancyThe basic principle of meal planning remains the same, butsince the nutritional requirements increase during pregnancy,emphasis should be in including nutrient dense foods i.e.,foods that give more nutrients per calorie consumed. Duringearly months, the mother often suffers from morning sicknessdue to the hormonal and physiological changes, when sheshould be given small amounts of foods with increasedfrequency. Solid carbohydrate rich foods like bread, biscuitand fruit given in the morning or before meals helps to relievenausea. Also fried, rich, strongly flavoured and spicy foodsneed to be avoided. To meet increased requirements themother should consume extra food. The mother can be givennutritious snacks in between meals rather than three meals aday thus increasing the frequency of feeding. Her feedingpattern should be 5-6 meals a day. Protein needs can be met byincluding good quality protein foods like meat, milk, egg,fish. Protein can also be obtained from pulses like soyabeanand groundnut at a lower cost. To improve protein quality, acombination of plant proteins, as that in cereals and pulses,with small amount of animal protein should be used. To meetadditional iron needs foodstuffs like whole grain cereals, riceflakes, puffed rice, dried fruits, green leafy vegetables, eggs,enriched cereals and organ meats can be given. Food rich indietary fibre like fresh fruits, vegetables, whole grain cerealswith plenty of fluids need to be included. This is to ward offconstipation which is a common problem during4,23,24pregnancy.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 8

Ingle P.V - Sociocultural, Healthy Nutrition & Eating, Exercise Pattern and Use of Ayurvedic Medicines in Pregnancy.Table 4: Balanced Diet for pregnant womenSr. No. Food Group Quantity in gms1 Cereals and millets 3002 Milk (ml) 5003 Roots and Tubers 1004 Green leafy vegetables 1505 Other vegetables 1006 Fruits 2007 Sugar 208 Fats and oils (visible) 30Role of supplements in pregnancy1. Protein: The additional protein is essential forŸGrowth of the foetusŸ Development of placentaŸ Enlargement of uterus, mammary glandŸ Increased maternal blood volumeŸ Formation of amniotic fluidŸ Preparation for labour, delivery, post partum period andlactation by maternal tissues.2. Fat:Linoliec acid requirements during this stage are 4.5percentage of total energy. Of this, some of the essential fattyacid needs are met with by the invisible fat. Therefore anintake of 30g of visible fat has been suggested to meet theessential fatty acid needs.3. Calcium:The additional calcium is needed for the growth anddevelopment of bones as well as teeth of the foetus and alsofor the protection of calcium resources of the mother to meetthe high demand of calcium during lactation.4. Iron:The requirement of iron increases from 30mg/day to38mg/day during pregnancy. The increased requirement of8mg/day is due to,ŸExpansion of maternal tissues including red cell mass,iron content of placenta and blood loss during parturition.Ÿ To build the iron store in foetal liver to last for atleast 4-6months after birth. This is because the baby's first foodmilk is deficient in iron. Generally infants are born with ahigh level of iron, 18-22g/100ml.5. Zinc:Deficiency of zinc adversely affects the outcome ofpregnancy. Apart from being a component of insulin andenzyme systems, it also participates in the synthesis of DNAand RNA, playing a significant role in reproduction. Hencezinc deficiency leads to foetal mortality, foetal,malformations and reduced intra uterine growth rate. The riskof LBW babies doubles and preterm delivery increases threetimes due to low zinc intake during pregnancy.6. Vitamins:Ÿ Vitamin AVitamin A requirements during pregnancy have beencomputed based on the vitamin A content of liver of thenewborn. The additional intake works out to 25 g/daythroughout pregnancy. Since this constitutes a very smallfraction of the RDA for normal women, no additionalallowance during pregnancy is suggested.Ÿ Vitamin DVitamin D is essential as it enhances maternal calciumabsorption. Its active form calcidiol and calcitriol can passthrough placenta with ease and help in calcium metabolism offoetus.Table 5: ICMR (Indian Council of Medical Research)Recommended dietary allowances for an expectant motherNutrient Normal Adult Woman Pregnant WomanEnergy (K/cal)Secondary 1875 2175Moderate 2225 2525Heavy 2925 3225Calcium (mg) 400 1000Protein (g) 50 65Fat (g) 20 30Iron (mg) 30 38Vitamin A (μg) 600 600Β carotene (μg) 2400 2400Thiamine (mg)Secondary 0.9 1.1Moderate 1.1 1.3Heavy 1.2 1.4Riboflavin (mg)Secondary 1.2 1.3Moderate 1.3 1.5Heavy 1.5 1.7Pyridoxine (mg) 2.0 2.5Ascorbic acid (mg) 40 40Niacin (mg)Secondary 12 14Moderate 14 16Heavy 16 18Folic acid (μg) 100 400Vitamin B121 1Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 9

Ingle P.V - Sociocultural, Healthy Nutrition & Eating, Exercise Pattern and Use of Ayurvedic Medicines in Pregnancy.Ÿ Thiamine, Riboflavin, NiacinAs the energy requirement increases during pregnancy, therequirement of these vitamins also increases25correspondingly.Role of Ayurveda in pregnancyDuring pregnancy there is tendency to put on undue weight.At this time, dietiing is not suitable advice. Use of honey isbest, as it helps one to loose weight. Harita appreciate the useof honey with Yogurt in 6th month. Rudolph Ballentine writes"The Ayurvedic scriptures say that Yogurt is an excellent foodif it is taken with honey. On this basis it is also said that thediabetic can take honey without harm, whereas he shouldavoid sugar assiduously. Conventional modern medicine bycontrast, has tended to forbid honey to the diabetic on therationale that it is carbohydrate. Interestingly enoughhowever, honey contain primarily fructose, which as we haveseen, is different from most sugars in that does not require6insulin for its metabolism.Use of ghee (clarified butter) is also advised to pregnant lady.It promotes digestion which is in accordance with researchwhich has shown that full fat Soya flour is digested with lessgas than the defatted preparations. Use of Mamsa Rasa (meatsoup) is also advised during pregnancy. It is sufficient tomaintain the serum protein level in body from 6th monthonwards. Use of Gokhru (Tribulus terrestris) is alsobeneficial. There is tendency of oedema on feet or samegeneralized in last trimester of pregnancy. Probably it checks11it and not allows it to be pathological one.Herbal drugs in pregnancyWomen may choose to use herbal supplements because theyconsider them safer during pregnancy than pharmaceuticalproducts. Herbs are not non-toxic just because they arenatural. Medicinal herbs may contain powerful,pharmacologically active compounds. Several animal studiesdescribed the adverse effects of herbal medicines to the fetus,26-29such as congenital malformations , intrauterine growthretardation, and reduction of fetal survival rate. A humanstudy in South Africa reported fetal distress as the outcome oftaking herbal medicines during pregnancy. Attitude towardsherbal medicines is a factor that influences use duringpregnancy. Other possible associated factors are age,28education level, and income.In one study, Two-hundred ten women (110 “users,” 100“non-users”) were studied. The probability of using herbalmedicines among women who had negative attitudes towardsthe use of herbal medicines was 50.0% less compared to thosewho had positive attitudes (OR = 0.51, 95% CI = 0.29 - 0.92).Women who had a positive attitude towards the safety ofherbal medicines were less likely to use herbal medicinesduring pregnancy. There were no significant associationsbetween usage and sociodemographic features, such as age,30-32income, race, and education.Exercise in pregnancyMany women enter pregnancy with regular aerobic andstrength-conditioning activities already a part of their dailylives. Other women see pregnancy as an opportunity tomodify their lifestyles to include more health.Recent investigations, focusing on both aerobic and strengthconditioningexercise regimens in pregnancy, have shown noincrease in early pregnancy loss, late pregnancycomplications, abnormal fetal growth, or adverse neonataloutcomes, suggesting that previous recommendations have23,24been overly conservative.Ÿ When and how to start exercise:Many women find that the best time to initiate an exerciseprogram is in the second trimester, when the nausea,vomiting, and profound fatigue of the first trimester havepassed and before the physical limitations of the thirdtrimester begin. Women who have been exercising prior topregnancy may continue their exercise regimens throughout33,34,38-41pregnancy.Ÿ Safety precautions:Some sport activities carry significant risk in pregnancy andare considered contraindicated. Women should not scuba divein pregnancy, as the fetus is not protected from decompression33sickness and gas embolism. Women are cautioned about thepotential for loss of balance and fetal trauma if theyparticipate in horseback riding, downhill skiing, ice hockey,gymnastics, or cycling during pregnancy. Under normalcircumstances and with appropriate hydration, moderateexercise at altitudes up to 1800–2500 m (6000–8250 ft) doesnot appear to significantly alter maternal or fetal well-being.However, women should be wary of hiking in a location34,36where they might fall.CONCLUSIONFrom this review we can conclude that proper care in thepregnancy is required. As, concern with knowledge ofantenatal care mother get maintain a good health. By gainingproper weight, mother can avoid problems like high or lowbirth weight baby and IUGR. Eating proper diet with propersupplements like iron, calcium, protein, vitamins and exercisein pregnancy maintain proper health. Use of ayurvedicpreparations and herbal formulations are beneficial in the safepregnancy and its outcome.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 10

Ingle P.V - Sociocultural, Healthy Nutrition & Eating, Exercise Pattern and Use of Ayurvedic Medicines in Pregnancy.REFERENCES1. W. Allan Walkar, The Harward Medical School Guide to “HealthyEating During Pregnancy” Mc-Grow Hill publication, 2006.2. Muthayya S. Maternal nutrition & low birth weight - what is reallyimportant? Indian journal of medicine, 2009, 130, 600-8.3. Janne Orskou, MD, Tine Brink Henriksen, MD, PhD, UlrikKesmodel, MD, PhD, and Niels Jørgen Secher. MaternalCharacteristics and Lifestyle Factors and the Risk of DeliveringHigh Birth Weight Infants. Obstetrics & Gynecology, 2003, 102,115-20.4. van Weissenbruch MM, Engelbregt MJ, Veening MA,Delemarrevan de Waal HA. Fetal nutrition and timing of puberty.Endocr Dev, 2005, 8, 15-33.5. Clapp JF. The effects of maternal exercise on early pregnancyoutcome. Am J Obstet Gynecol, 1989, 161, 1453–7.6. Rudolph Ballentine, M.D.- Diet & Nutrition, Chap. 17-4397. Clapp JF, Lopez B, Harcar-Sevcik R. Neonatal behavioral profileof the offspring of women who continued to exercise regularlythroughout pregnancy. Am J Obstet Gynecol, 1999, 180, 91–4.8. Antenatal care routine care for the healthy pregnant woman,National Collaborating Centre for Women's and Children'sHealth, Clinical Guideline, 2008.9. Dwivedi, M: Ayurvedic Concept of Food in Pregnancy. AncientScience of Life, 1995, 14, 245-47.10. Mei-Yueh Chang, Chun-Hua Kuo and Kuei-Feng Chiang, MPH,The effects of pre-pregnancy body mass index and gestationalweight gain on neonatal birth weight in Taiwan, InternationalJournal of Nursing and Midwifery, 2010, 2(2), 28-34.11. Carol A Hickey, Sociocultural and behavioral influences onweight gain during Pregnancy, Am J Clin Nutr, 2000, 71(suppl),1364S-70S.12. Ashworth A. Effects of intrauterine growth retardation onmortality and morbidity in infants and young children. Eur J ClinNutr, 1998, 52 (Suppl 1), S34-S42.13. Kramer MS, Goulet L, Lydon J. Socio-economic disparities inpreterm birth: causal pathways and mechanisms. PaediatrPerinat Epidemiol, 2001, 15 (Suppl 2), 104-23.14. Grantham-McGregor SM. Small for gestational age, termbabies, in the first six years of life. Eur J Clin Nutr, 1998, 52,(Suppl 1): S59-S64.15. Khong TY, De Wolf F, Robertson WB, Brosens I. Inadequatematernal vascular response to placentation in pregnanciescomplicated by pre-eclampsia and by small-for-gestational ageinfants. Br J Obstet Gynaecol, 1986, 93, 1049-59.16. Haram K, Svendsen E and Myking O. Growth Restriction:Etiology, Maternal and Neonatal Outcome. A Review. CurrentWomen's Health Reviews, 2007, 3, 145-60.17. Shulman CE, Dorman EK. Importance and prevention of malariain pregnancy. Trans R Soc Trop Med Hyg, 2003, 97, 30-5.18. Lin CC, Santolaya-Forgas J. Current concepts of fetal growthrestriction: part I. Causes, classification, and pathophysiology.Obstet Gynecol, 1998, 92, 1044-55.19. Bajoria R, Hancock M, Ward S, D'Souza SW, Sooranna SR.Discordant amino acid profiles in monochorionic twins withtwintwin transfusion syndrome. Pediatr Res, 2000, 48, 821-820. Churchill D, Bayliss H, Beevers G. Fetal growth restriction.Lancet, 2000, 355, 1366-7.21. Resnik R. Intrauterine growth restriction. Obstet Gynecol, 2002,99: 490-6.22. Rees S, Mallard C, Breen S, Stringer M, Cock M, Harding R.Fetal brain injury following prolonged hypoxemia and placentalinsufficiency: a review. Comp Biochem Physiol A Mol IntegrPhysiol, 1998, 119, 653-60.23. Kardel KR, Kase T. Training in pregnant women: effects on fetaldevelopment and birth. Am J Obstet Gynecol, 1998, 178, 280–6.24. Clapp JF, Simonian S, Lopez B, Appleby-Wineberg S, Harcar-Sevcik R. The one-year morphometric and neurodevelopmentaloutcome of the offspring of women who continued to exerciseregularly throughout pregnancy. Am J Obstet Gynecol, 1998,178, 594–9.25. Aamer Imdad, Afshan Jabeen and Zulfiqar A Bhutta, Role ofcalcium supplementation during pregnancy in reducing risk ofdeveloping gestational hypertensive disorders: a meta-analysisof studies from developing countries, BMC Public Health 2011,11, S13- 8.26. Hussin, A. Adverse effects of herbs and drug-herbal interactions.Malays J Phar, 2001, 1, 39-44.27. Mabina MH, Pitsoe SB, Moodley J. The effect of traditionalherbal medicines on pregnancy outcome: the King Edward VIIIHospital experience. S Afr Med J, 1997, 87, 1008-10.28. Ni H, Simile C, Hardy AM. Utilization of complementary andalternative medicine by United States adults: results from the1999 national health interview survey. Med Care, 2002, 40:353-8.29. Nordeng H, Havnen GC. Impact of socio-demographic factors,knowledge and attitude on the use of herbal drugs in pregnancy.Acta Obstet Gynecol Scand, 2005, 84, 26-3330. Rahman A, Sulaiman S, Ahmad Z, Salleh H, Daud W, Hamid A.Women's Attitude and sociodemographic characteristicsinfluencing usage of herbal medicines during pregnancy inIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 11

Ingle P.V - Sociocultural, Healthy Nutrition & Eating, Exercise Pattern and Use of Ayurvedic Medicines in Pregnancy.Tumpat district, Kelantan. Department of Community Medicine,Department of Pharmacology, School of Medical Sciences,Universiti Sains Malaysia, Kelantan, Malaysia.31. Eisenberg D, David RB, Ettner SL, Trends in alternativemedicine use in the United States, 1998, 280, 1569–75.32. Gibson PS, Powrie R, Star J. Herbal and alternative medicineuse during pregnancy: a cross sectional survey. Obstet Gynecol2001, 97, S44–S45.33. Kulpa PJ,White BM,Visscher R. Aerobic exercise in pregnancy.Am J Obstet Gynecol, 1987, 156, 1395–403.34. Klebanoff MA, Shiono PH, Carey JC. The effect of physicalactivity during pregnancy on preterm delivery and birth weight.Am J Obstet Gynecol, 1990, 163, 1450–6.35. Klebanoff MA, Shiono PH, Carey JC. The effect of physicalactivity during pregnancy on preterm delivery and birth weight.Am J Obstet Gynecol, 1990, 163, 1450–6.36. Kulpa PJ,White BM,Visscher R. Aerobic exercise in pregnancy.Am J Obstet Gynecol, 1987, 156, 1395–403.37. Hall DC, Kaufmann DA. Effects of aerobic and strengthconditioning on pregnancy outcomes. Am J Obstet Gynecol,1987, 157, 1199–203.38. Hatch MC, Shu X, McLean DE, Levin B, Begg M, Reuss L.Maternal exercise during pregnancy, physical fitness, and fetalgrowth. Am J Epidemiol, 1993, 137, 1105–14.39. Todros T, Adamson SL, Guiot C. Umbilical cord and fetal growth -a workshop report. Placenta, 2002, 23 (Suppl A), S130- S132.40. Camporesi EM. Diving and pregnancy. Semin Perinatol, 1996,20, 292–302.41. Paisley T.S., E.A. Joy, and R.J. Price. Exercise duringpregnancy: A practical approach. Current Sports MedicineReports 2, 2007, 325-30.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 12

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaDrug Induced Syndromes: An Overview1 2 3 4Mahendra Kumar BJ , Soumya M , Jyothi K and Jagadish B. D*1Director PG Studies, Prof. & Head, Department of Pharmacy Practice, JDT Islam College of Pharmacy, Jamiath Hill, Kozhikode, Kerala.2Lecturer, Department of Clinical Pharmacy, SAC College of Pharmacy, BG Nagara, Karnataka3,4Pharm D Students, Department of Clinical pharmacy, SAC College of pharmacy, KarnatakaA B S T R A C TSubmitted: 04/07/2012Accepted: 12/08/ 2012Many drugs have come into the market in recent years and its usage is increased for multiple disorders which in turn leads to poly pharmacy andincreased drug related problems. One such drug related problem is Drug-induced syndrome. These syndromes are one of the major problems inthe health care sector. Drug related problems are found to be a reason for hospital admission and also for an increased patients stay in thehospital. The syndromes can be associated with any pathological conditions or may be drug related. This overview article provides theinformation regarding the different drug induced syndromes with its causative agents, clinical manifestation and therapy.Keywords: Drug induced syndrome, drug related problem,INTRODUCTIONThe word "Syndrome" derived from the Greek wordsundrom, which means concurrence of symptoms, or fromword sundromos, which means running together. Syndromeis a set of symptoms occurring together. In medical contextsyndromes are classified as syndromes caused due toenvironmental causes, cardiovascular, iatrogenic, neoplastic,congenital, endocrine, pulmonary, infectious, renal,neurological, gastrointestinal, reticulo-endothelial,1hematologic, others.Drug-induced syndromes or iatrogenic (physician induced)syndromes are produced by drugs themselves and leads tocertain pathological changes. These are temporally relatedwith starting a drug, and the symptoms and signs generally2, 3regress with its discontinuation. The increasing number andcomplexity of diagnostic procedures and therapeutic agents,monitoring of untoward events is essential, and attentionshould be paid to educational efforts to reduce the risks of4iatrogenic illness. Important risk factors for adverse drugevents or reactions included polypharmacy, drugs withnarrow therapeutic range, renal elimination of drugs, age >65years and use of anticoagulants or diuretics. Since medicationerrors are strong risk factors for preventable adverse drugevents or reactions, strategies have to be put in place for theirreduction. Such strategies include ensuring that all personsinvolved in the medication process (nurses, pharmacists andAddress for Correspondence:Dr. BJ Mahendra Kumar, Director PG Studies, Prof. & Head, Department ofPharmacy Practice, JDT Islam College of Pharmacy, Jamiath Hill, Kozhikode,Kerala.Email address:bjmahendra2003@yahoo.co.inphysicians) have good pharmacological knowledge,computerization of the entire medication process, and theengagement of a sufficient number of clinical pharmacists on5the wards.The drugs with single or combination can leads to iatrogenicsyndromes with severity ranging from mild to severe.Awareness should bring towards health care professionals forthe management of drug induced syndromes. This articlebrings brief description of drug induced syndromes includingcausative agents, symptoms and management.Drug Rash with Eosinophilia and Systemic symptomsSyndrome (DRESS): DRESS syndrome reflects a serioushypersensitivity reaction to drugs and has been classifiedunder a delayed type IVb hypersensitivity reaction, where T6helper type II cells play a significant role. (Fig 1)Causative drugs: Anticonvulsants, Sulfonamides, Dapsone,Allopurinol, Minocycline, Gold, Hydroxychloroquine(HXQ) Sulfate, Isoniazid, Rifampicin, Ethambutol and6, 7Pyrazinamide.Symptoms: Fever is usually present. Skin eruption may varyfrom a diffuse maculopapular inflammatory rash toerythroderma, Stevens–Johnson syndrome or erythemamultiform. Concerning organ involvement, lymph nodes,liver and kidney are frequently affected; lung and heart are6involved in a minority of the cases.Treatment: Causative drugs should be withdrawn as a part ofthe treatment and steroids are useful for patients with lifethreateningvisceral manifestations such as interstitialPneumonitis or nephritis. In milder cases, topical steroidsimprove the skin manifestations. Interferon-α is also useful6, 7for long-lasting DRESS.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 13

Mahendra Kumar BJ - Drug Induced Syndromes: An OverviewSerotonin Syndrome: Serotonin Syndrome is a toxic statelargely attributable to the changes in the sensitivity ofserotonin receptor system, resulting from increasedserotonergic activity in central neurologic system, due to8serotonergic agents either in overdose or in combination.Causative drugs: L-tryptophan, Amphetamine, Lithium,Dextromethorphan, Merperidine, Fluoxetine, Trazodone,9Venlafaxine, Buspirone.Symptoms: Neuromuscular (clonus, myoclonus, tremor,hyperreflexia) and autonomic (fever, mydriasis, tachycardia,tachypnea) symptoms, mental status changes (confusion,9agitation) and may result in death in severe cases.Treatment: The main and foremost therapy is the cessation ofthe medication and the syndrome usually resolves within 24hours after the withdrawal of the causative drug. If serotoninsyndrome has occurred as a result of an acute overdose,activated charcoal may be beneficial soon after the ingestion.Supportive care is the mainstay of treatment. Hyperthermiashould be treated with aggressive external cooling measuressuch as ice, mist, fans and a cooling blanket. Rigidity,seizures, and agitation are treated with Benzodiazepines. Onestudy revealed that the severe symptoms can be successfullytreated with Cyproheptadine (5-hydroxytryptamine9antagonist).Red Man Syndrome (Red-Neck Syndrome /RMS): Red-Neck syndrome is characterized by pruritus; erythema of theface, neck, and upper torso; and in severe cases, angioedema10, 11and cardiovascular collapse.Causative drugs: Vancomycin, Ciprofloxacin, Amphotericin11B, Rifampicin and Teicoplanin.Symptoms: Sensation of burning and itching, agitation,11dizziness, headache, chill, fever and perioral paresthesia.Treatment: The effects of red man syndrome can be relievedby antihistamines. Pretreatment with hydroxyzine cans i g n i f i c a n t l y r e d u c e e r y t h e m a a n d p r u r i t u s .Diphenhydramine hydrochloride intravenously or orally can11abort most of the reactions.Blue-Gray Syndrome: Blue gray syndrome is anamiodarone related hyperpigmentation considered as a skin12storage disease secondary to drug deposition.12, 13, 14Causative drug: Amiodarone.Symptoms: Blue-gray skin pigmentation, dyspnea, cough and12, 13, 14fever. (Fig 2)Treatment: Discontinuation of the causative agent withoutintroducing other medication is considered as the mostpracticed therapy in clinical setup. Careful and regular long13, 14term follow-up is mandatory.Severe Dapsone Hypersensitivity Syndrome: Adversereactions to Dapsone, a potent anti-inflammatory, antiparasiticcompound, first line drug for leprosy includedramatic, generalized hypersensitivity syndrome termed asDapsone syndrome which has a frequency of 0.2% - 0.5% inpatients on Dapsone therapy typically begins with several15weeks of starting the drug.15, 16, 17Causative drug: Dapsone.Symptoms: High fever lasting for about 4-5 days associatedwith malaise, sore throat, dysphagia, productive cough, and a16pruritic rash, methamoglobinemia and hemolytic anemia.(Fig 3) .Treatment: Patients can be treated with corticosteroids bothorally (Prednisolone 40 mg/d) and topically (Beclomethasonedipropionate ointment 0.025%, 2 times a day). Cetirizine andHydroxyzine are also given for the management of Dapsone16syndrome.Neuroleptic Malignant Syndrome (NMS): NMS is a rare,but sometimes fatal, adverse reaction of neuroleptics18characterized principally by fever and rigor.Causative drugs: Butyrophenones, Phenothiazines,Thioxanthenes, Hydroxyzine, Reserpine;, Amitriptyline,Amoxapine, Desipramine, Maprotiline, Phenelzine,Tranylcypromine, Diazepam, Lorazepam, Carbamazepine,Phenytoin, Amantadine, Bromocriptine, Levodopa,18Lithium.Symptoms: Dopaminergic blockade cardinal featuresincluding autonomic dysfunction, altered mental status,muscular rigidity, hyperthermia, cogwheel rigidity,dyskinesia, dysphagia, festinating gait, lead pipe musclerigidity, oculogyric crisis and opisthotonos are seen in19patients.Treatment: Strong suspension of NMS neuroleptics should bedone immediately. Supportive measures are of greatimportance especially rehydration and cooling.Bromocryptine and Dantrolene given in divided doses orally20or parenterally up to 60mg per day.Nicolau Syndrome (Livedoid Dermatitis/NS): NicolauSyndrome is a rare adverse drug reaction with unknown21pathogenesis at the site of intramuscular drug injection.Causative drugs: Non-steroidal Anti-Inflammatory Drugs,21Corticosteroids, and Penicillin.Symptoms: Pain around the injection site soon after injection,followed by erythema, livedoid patch, haemorrhagic patch,finally resulting into the necrosis of skin, subcutaneous fat,22and muscle tissue. (Fig 4)Treatment: Treatment ranges from local care to surgicalintervention. Antibiotic use is restricted to cases with signsIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 14

Mahendra Kumar BJ - Drug Induced Syndromes: An Overviewand symptoms of infection. Use of Vasoactive agents(Pentoxyphylline) together with hyperbaric oxygen may bebeneficial considering the vascular pathogenesis. Vasospasmmay be relieved by the phosphodiesterase inhibiting action ofpentoxyphylline. Topical corticosteroids are effective foracute tissue inflammation. Wound care, debridement,dressings, and flap reconstruction are ideal surgical measures.Failure to recognize the extent of fat necrosis and poor bloodsupply leads to inadequate debridement and poor woundhealing. The patients are then prone to repetitive cycles ofinfection leading to extensive scarring, soft tissue23indentation, and unsightly skin grafts.Warfarin-Induced Skin Necrosis: Warfarin-induced skinnecrosis due to oral anti-coagulation therapy causes injury tothe skin. Cutaneous injury from warfarin begins as localizedparesthesias with an erythematous flush, progresses topetechiae and hemorrhagic bullae, and may eventually result24in full-thickness skin necrosis.24, 25, 26Causative drug: Warfarin.Symptoms: Patients may initially experience localparesthesias with an erythematous flush followed by intensepain and rapid development and coalescence of petechiae,with concomitant accumulation of subcutaneous edemaresulting in a peaud'orange appearance. During the first 24hours after the first sign of skin lesions, hemorrhagic bullaemay occur, which signals irreversible tissue injury. Full-24thickness skin necrosis is the end stage of cutaneous injury.(Fig 5)Treatment: Vitamin K intravenously and fresh frozen plasma(FFP) can be given to the patient to reverse the effects of the24warfarin.Sweet Syndrome: Sweet syndrome is a condition associatedwith autoimmune phenomena including relapsingpolychondritis, drug-induced lupus, and development of27Anti-Neutrophil Cytoplasmic Antibodies (ANCAs).Causative drugs: Abacavir, All-Trans Retinoic Acid,Bortezomib, Carbamazapine, Celecoxib, Clozapine,Diclofenac, Diazepam, Furosemide, Hydralazine, Imatinib,Lenalidomide, Minocycline, Nitrofurantoin, Norfloxacin,Ofloxacin, Pegfilgastrin, Propylthiouracil, Quinupristin,27Dalfopristin, Trimethoprim-Sulfamethoxazole.Symptoms: Rapid onset of fever, leukocytosis, painfulerythematous and edematous papules, plaques and nodules27infiltrated by neutrophils.Treatment: Causative drugs should be suspended andsystemic corticosteroids can be given to the patient for the28management of lesions.Stevens - Johnson syndrome (SJS): SJS is a wellrecognizedimmune complex mediated hypersensitivityreaction that affects all age groups. It has classic systemic,29mucosal and dermatologic manifestations.Causative drugs: Ibuprofen, Allopurinol, Chloroquine,Penicillamine, Sulfasalazine, Carbamazepine, Etosuximide,Phenobarbital, Phenytoin, Valpoic Acid, Amoxicillin,Imipenem, Ciprofloxacin, Clindamycin, Doxycyclin,Erythromycin, Sulfadiazine, Sulfamethoxazole-Trimethoprim, Dapsone, Fluconazole, Nystatin, Nevirapine,Abacavir, Efavirenz, Tamoxifen, Verapamil, Enalapril,30,31,32Acetazolamide.Symptoms: Erythema with bullous, eroded lesions of skin and29mucous membrane and cholestatic liver disease.Treatment: Withdrawal of the causative drugs, rapidlyinitiating supportive care in an appropriate setting and themanagement of fluid and electrolyte requirements. Treatmentstarted with IV fluids and combination of corticosteroid is29used.Toxic Epidermal Necrolysis (Lyell Syndrome/TEN): TENis a severe adverse cutaneous drug reaction thatpredominantly involve the skin and mucous membranes. It isan autoimmune blistering disease, including linear IgAdermatosis and paraneoplastic pemphigus but alsopemphigus vulgaris and bullous pemphigoid, acutegeneralized exanthematous pustulosis (AGEP), disseminatedfixed bullous drug eruption and staphyloccocal scalded skinsyndrome (SSSS).Causative drugs: Sulfonamides, Pyrazolones, Barbiturates,Ibuprofen, Allopurinol and Carbamazepine.Symptoms: Hyper and hypopigmentation of the skin, naildystrophies, ocular complications, trichiasis, symblepharon,distichiasis, visual loss, entropion, ankyloblepharon,lagophthalmos and corneal ulceration.Treatment: Prompt identification and withdrawal of thecausative drug, systemic steroids, high-dose intravenousimmunoglobulin Ciclosporin, and Cyclophosphamide31(CPP).Rabbit's Syndrome (RS): RS is a rare movement disordergenerally associated with prolonged use of antipsychoticscharacterized by involuntary, rhythmic, fast and finemovements of the oral and masticatory muscles along thevertical axis of the mouth. It takes its name from an unusual33resemblance to the chewing motions of rabbits.Causative drugs: Methotrimipramine, Benzotropine,M e s o r i d a z i n e , C l o r a z e p a t e , C h l o r p r o m a z i n e ,Trifluoperazine, Lithium, Clocapramine, Propericiazine,Levopromazine, Bromperidol, Sulpiride, Thioridazine,Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 15

Mahendra Kumar BJ - Drug Induced Syndromes: An OverviewHaloperidol, Zuclopentixol, Biperidene, Perphenazine,Amitriptyline, Paroxetine, Risperidone, Clozapine,33Olanzapine, Aripiprazole.Symptoms: RS is characterized by involuntary and rhythmicmovements along the vertical axis of the mouth occur at afrequency of approximately 5 Hz. The oral movements areoften accompanied by a popping sound that is produced by therapid smacking on one's lips. This syndrome is limitedexclusively to the territory of the oral and masticatory34muscles and does not involve the tongue.Treatment: Rabbit's Syndrome typically responds favorablyto anticholinergic agents such as Benztropine, Biperiden,Procyclidine and Trihexyphenidyl. This Syndrome typicallydisappears few days after the introduction of ananticholinergic agent, but can, on occasion, reappear after34stopping anticholinergic medications.Vanishing Bile Duct Syndrome (VBDS): VBDS is a rarecause of progressive cholestasis and is mostly related withdrugs. Drugs act as a hapten and produce autoantibodiesagainst cytokeratin which is in the bile duct, skin,conjunctival epithelium and orogenital mucosa.Autoantibodies destroy biliary apparatus with resultantdisappearance of intrahepatic bile duct.Causative drugs: Anticonvulsants, Sulfonamides, Penicillins,Allopurinol, Nonsteroidal Anti-Inflammatory Drugs.Symptoms: Cholestasis, pruritis, weight loss, malaise,disappearance of intrahepatic bile ductTreatment: The therapy involves mainly the withdrawal of thecausative agent, supportive care, and the usage ofimmunosuppressants. Steroids, choleretic agents are also29useful for the management purpose.H a n d - F o o t S y n d r o m e ( P a l m a r - P l a n t a rE r y t h r o d y s a e s t h e s i a / H F S ) : P a l m a r - P l a n t a rErythrodysaesthesia is a relatively common adverse effect ofchemotherapeutic drugs.Causative drugs: 5-Fluorouracil, Doxorubicin, Docetaxel,Idarubicin, and Cytarabine.Symptoms: Erythema, tenderness, tingling, numbness, dryrash and desquamation over the palms and soles. (Fig 6)Treatment: The management of hand-foot syndrome entailsimmediate discontinuation of the causative drug andsymptomatic care. Steroids and pyridoxine show goodresponse in patients. The causative drug may be cautiously re-35introduced in a lower dose.Purple Glove Syndrome (PGS): Purple Glove Syndrome iscaused by intravenous administration of phenytoin resultingin soft tissue injury at the site of injection leading to oedemaand purplish-black discoloration of the hand.Causative drugs: Phenytoin.Symptoms: Intense pain, purplish black discoloration andoedema at the site of injection.Treatment: The management of PGS is mainly conservative,which includes limb elevation and physiotherapy. Use of lowconcentration local anaesthetic for brachial plexus block hasan added advantage of preserving motor function to facilitatephysiotherapy in addition to providing adequate analgesia36and relief of vasospasm.Creutzfeldt-Jakob like Syndrome (CJS): CJS syndromecommonly with lithium products is characterisized bydementia and periodic complexes on EEG.Causative drugs: Lithium with Levodopa, Lithium, Lithiumwith Nortriptyline, Amitriptyline.Symptoms: Dementia, confusional state, myoclonus,Parkinson's syndrome, dystonia, grimacing, dysarthria,oculogyric crisis, blepharospasm, swallowing difficulties,torticollis and trismus.Treatment: patients are advised to discontinue the causativedrugs. When the patients are treated with high potencyantipsychotic drugs a low starting dose is recommended toreduce the risk of acute dystonia compared with a standard37dose.Fetal valproate syndrome (FVS): Valproic acid is acommonly used anticonvulsant and also used in the treatmentof bipolar affective disorder. Although, its teratogenic effectsare well known, the exact mechanism is unclear which resultin multiple birth defects, dysmorphic facies, developmentaldelay, learning difficulties and/or behavioural problems.Fetal valproate syndrome is the term used to encompass theseteratogenic effects.Causative drug: Sodium valproate.Symptoms: Neural tube defects, trigonocephaly, radial raydefects, pulmonary abnormalities,coloboma of iris/optic, low verbal IQ, autism and autisticspectrum disorder.Treatment: High dose folic acid (4 mg/day) is recommendedduring pregnancy, starting at least 6 weeks pre-conceptionand continuing through the first trimester. Folic acidsupplements are thought to be protective againstmalformations, in particular against neural tube defects.Some clinicians are of the opinion that it may be advisable forpregnant women to continue folic acid until delivery, due tothe continued development of the fetal brain throughout thepregnancy. Serum α-feto-protein levels in the secondtrimester may be helpful in picking up open neural tubedefects. Antenatal scans should be able to pick up most majormalformations, especially if specific attention is being paid38towards anomalies known to be associated with FVS. (Fig 7)Pseudolymphoma Syndrome (PS): PS is a rare form ofadverse cutaneous drug reaction.Causative drugs: Anti-arrhythmic, anti-hypertensive, anti-Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 16

Mahendra Kumar BJ - Drug Induced Syndromes: An Overviewpsychotic, antibiotic, anti-convulsant, anti-thyroid, antiinflammatorydrugs. It has also been described with biologicdrugs (TNF-Α antagonist, adalimumab, infliximab,etanercept), α-Interferon and other cytokines.Symptoms: Fever, cutaneous eruption, lymphadenopathy andhepatosplenomegaly. (Fig 8)Treatment: Cessation of the causative drug is the management39of Pseudolymphoma Syndrome .Gray baby syndrome (Gray or Grey syndrome/GBS):Gray syndrome is a rare but serious side effect occurs innewborn infants (especially premature babies) following theintravenous administration of the antimicrobialchloramphenicol.Causative drug: Chloramphenicol.Symptoms: Vomiting, ashen gray color of the skin, limp bodyFig. 4: Cutaneous necrosisFig. 1: Diffuse erythema on the patient's right armFig. 6: Dry rash, erythema, blistering and desquamationof the palmFig. 2: Blue-gray hyper pigmentation of the face(Blue Gray Syndrome)Fig. 5: Erythematous skin lesionFig. 3: Patient photography shows erythematous exofoliativemaculopapules on the edematous face (A), and polymorphicerythematous maculopapules disseminated on lower legs (B)Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 17

Mahendra Kumar BJ - Drug Induced Syndromes: An OverviewFig. 7: Examples of major malformations seen in FVS. (i) Repaired neural tube in lumbo-sacral region(ii) Coloboma of the iris (iii) Split hand.Fig. 8: Generalized maculopapular eruptions on the trunkand fore limbtone, hypotension, cyanosis, hypothermia, cardiovascularcollapse.Treatment: Chloramphenicol therapy is discontinuedimmediately. Phenobarbital and third generationcephalosporin effectively can be given at recommended40doses.CONCLUSIONSince last few years there are more reports of the adverseeffects induced by the drugs, experts says that additional careis required for the better patient care and also to improve thequality of life. The drug induced syndromes enhances thepatient duration of hospital stay and cost of the therapy. Theentire health care professional should be aware of theiatrogenic diseases and its management.REFERENCES1. Medical Syndrome [internet]. [Cited 2011 Dec 27]; Availablefrom: URL: http://www. medindia. net/patients /patientinfo/syndrome/home.asp.th2. Tripati KD. Essentials of Medical Pharmacology. 6 ed. NewDelhi: Jaypee Brothers Medical Publisher; 2008:86.3. Satoskar RS, Bhandarkar SD, Ainapure SS. Pharmacologythand Pharmacotherapeutics. 6 ed. Mumbai: Popular PrakaShan; 1999: 41.4. Steel K, Gertman P M, Crescenzi C, Anderson J. Iatrogenicillness on a general medical service at a university hospital.Qual Saf Health Care 2004; 13:76–81.5. Melcher AK, Schlienger R, Lampert M, Haschke M, Drewe J,Krähenbühl S. Drug-related problems in hospitals: a review ofthe recent literature. Drug Saf. 2007; 30(5):379-407.6.Volpe A, Marchetta A, Caramaschi P, Biasi D, Bambara LM,Arcaro G. Hydroxychloroquine-induced DRESS syndrome.Clin Rheumatol 2008; 27:537–9.7. Ghislain PD, Roujeau JC. Treatment of severe drug reactions:Stevens - Johnson syndrome, Toxic Epidermal Necrolysis andHypersensitivity Syndrome. Dermatol Online J 2002; 8(1):5.8. Sahieri V, Aki OE. Serotonin syndrome associated withlinezolid use: a case report. Turk Psikiyatri Der 2009;20(4):398-402.9. Serotonin syndrome.Utox Update 2002:Sect. Utah 4(4):1-4.10. Bailey P, Gray H. An elderly woman with 'Red Man Syndrome'in association with oral vancomycin therapy: a case report.Cases J [online] 2008; 1:111.Doi:10.1186/1757-1626-1-111.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 18

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaProspective Monitoring and Reporting of Adverse Drug Reactions associated with Antiplateletand Antiepileptic Drugs in a South Indian Tertiary Care Teaching Hospital1 1 2 3 4 4Varun T , Sebastian J , Ramesh A* , Narahari MG , Keshava Bs and Harsha S1Department of Pharmacy Practice, Talla Padmavathi College of Pharmacy, Warangal2Department of Pharmacy Practice, JSS College of Pharmacy, Mysore.3 4,5Department of Medicine, Department of Nuerology, JSS Medical College Hospital, Mysore.A B S T R A C TSubmitted: 17/03/2012Accepted: 25/06/2012A prospective monitoring of adverse drug reactions associated with antiplatelet and antiepileptic drugs was carried out in a tertiary care teachinghospital. Patients diagnosed with Acute Coronary Syndrome (ACS) or ischemic stroke receiving antiplatelet drugs (Aspirin and Clopidogrel) andepileptic patients receiving antiepileptic drugs were followed for a period of six months prospectively at a tertiary care teaching hospital. WHOprobability scale and Naranjo's algorithm, Modified Hartwig and Seigel scale, and Modified Shumock and Thornton scales were applied to assessthe causality, severity and preventability of the reported ADRs. At the end of the study period, 15 ADRs were observed with Aspirin and 14 ADRswere observed with Clopidogrel in antiplatelet agents' class and 24 ADRs with Phenytoin and 12 ADRs with Valproic acid in antiepileptic agents'class. Among the antiplatelet agents, 82.75% of ADR's were found probable and 37.93% ADRs were possible. In antiepileptic drug class, 73.33%ADRs were found probable. In assessment of severity level, 6 ADRs were found in severity level 1 and 20 ADRs were in level 3 in severity inantiplatelet agents class and in antiepileptic drugs class 9 ADRs were found in level 1 and 23 ADRs were found level 2 severity, and 15 ADRs werefound preventable in anti epileptic agents. Medications were discontinued in 14 cases and the dose was adjusted in 10 cases. Phenytoin andSodium Valproate were found responsible for majority ADRs in Anti epileptic drugs class and Aspirin accounted for more number of ADRs inantiplatelet agents' class.Keywords: Adverse Drug Reactions, Antiplatelets, Antiepileptic drugs.INTRODUCTIONWorld Health Organization defines ADR as a response to adrug that is noxious and unintended and occurs at dosesnormally used in man for the prophylaxis, diagnosis, andtherapy of disease, or for modification of physiological1function. Adverse drug reactions (ADRs) occur frequently inmodern medical practice due to various pre disposing factors,resulting in increasing the morbidity, mortality and cost ofcare. Worldwide clinically significant ADRs occurapproximately in 20% of hospitalized patients and found to be2the fourth leading cause of mortality.Patients with cardiovascular diseases and epilepsy areparticularly vulnerable to ADRs due to their advanced age,polypharmacy, pathophysiology of the disease, age relatedchanges in liver and kidney function and the influence of heartdisease on drug metabolism. The ADR potential for aparticular drug varies with the individual, the disease beingAddress for Correspondence:Dr. Ramesh Adepu, Professor, Department of Pharmacy Practice, JSS Collegeof Pharmacy, SS Nagar, Mysore – 570 015E-mail: adepu63@gmail.comtreated, and the extent of exposure to other drugs. Majority ofsignificant ADRs involving cardiovascular drugs are2, 3predictable and therefore preventable.Across the world, after the stroke and the dementia, epilepsyconstitutes the common neurological condition seen by4neurologists in elderly. In India approximately 5.5 millionpeople are suffering from Epilepsy, among them 4.1 millionpatients resides in rural area and every year half million new5patients are added to the existing list. The ultimate goal of theepilepsy treatment is to make the patient free from seizureswithout adverse effects of medication and improved qualityof life. Over 80% of patients may achieve seizurefree statewith one suitable antiepileptic medication. But the remaining20% of patients may require poly therapy for seizure control.Majority antiepileptic agents suppress the pathologicalneuronal hyper excitability that constitutes the finalsubstrates in many seizure disorders was considered to beresponsible for adverse drug reactions. The other drug relatedproblems such as drug interactions also contribute to Adverse6Drug Reactions that may add to the economic burden.Assessing and resolving the potential drug related problemssuch as ADRs will improve the therapeutic outcomes and alsohelps in improving patients' quality of life.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 20

Ramesh A - Prospective Monitoring and Reporting of Adverse Drug Reactions associated with Antiplatelet and Antiepileptic Drugs in a South Indian Tertiary Care Teaching HospitalMETHODSA prospective observational study was carried out over aperiod of 6 months from June to December 2009 in a tertiarycare teaching hospital in Mysore. All patients who visited asthe out-patients and admitted as in-patients in the departmentsof Neurology and Medicine of JSS Hospital, Mysore with aclinical diagnosis of epilepsy, Acute Coronary Syndrome andIschemic stroke were enrolled in to the study. TheInstitutional Ethical Committee of JSS College of Pharmacy,Mysore has approved the study and strict confidentiality wasassured for all the collected data.A suitably designed documentation form was used to collectthe demographic details, clinical diagnosis, dose, frequencyand dosage form of Anti Epileptic Drug (AED) andantiplatelet agents, tests performed etc. During the studyperiod, the patients were followed up regularly to monitor andreport suspected adverse drug reactions (ADRs) usingCDSCO ADR notification form. The causality associationbetween the drugs and the reactions were assessed using7 8Naranjo's Algorithm and WHO probability scale . Severityof the ADRs was assessed with the help of Modified Hartwig9and Siegel scale . Preventability of the ADRs was assessed by10the modified Shumock and Thornton scale .RESULTSA total of 439 patients with a clinical diagnosis of epilepticseizures and 170 patients with a diagnosis of Acute CoronarySyndrome (ACS) and Ischemic stroke were followed over aperiod of six months. During the study period, 45 ADRs weredetected from 45 epileptic patients with an incidence rate of10%. Patients with ACS and Ischemic Stroke experienced 29ADRs with an incidence rate of 17%. Out of 45 patients in theantiepileptic group, 23 patients were male in the age group of8 years to 60 years and 22 patients were female patients in theage group of 11 years to 40 years. In the antiplatelet agentsgroup 17 patients were male patients, and 12 female patientsin the age group of 41 to 70 years.Phenytoin (23 ADRs) and Valproic acid (13 ADRs) were thedrugs responsible for more ADRs in anti epileptic drugs classand Aspirin (15 ADRs) and Clopidogrel (14 ADRs) havecontributed for ADRs in antiplatelet agents' class. Details ofantiepileptic medications and antiplatelet agents implicatedin ADRs are presented in Table. 1.The organ systems affected predominantly by the ADRs arecentral nervous system (21) Gastrointestinal (15) and Skin(14). Majority of the reported ADRs belong to level 2 of mildseverity in antiepileptic class of drugs and antiplatelet agentscaused ADRs belonging to level 3 of moderate severity.Majority ADRs of the study medications were found notpreventable. Details of Severity and Preventability arepresented in Table.2.Table :1 Antiplatelet and antiepileptic Medicationsimplicated in ADRAnti epileptic Medications Number of ADRs Percentageimplicated in ADR (n=45) (%)Phenytoin 24 53.33Valproic acid 12 26.66Carbamazepine 4 8.88Phenobarbitone 3 6.66Divalproex sodium 1 2.22Levetiracetam 1 2.22Anti platelet agents Number of ADRs Percentageimplicated in ADR (n=29) (%)Aspirin 15 51.72Clopidogrel 14 48.27ADR: Adverse Drug Reaction.Table 2: Preventability and severity of ADRsAntiplatelets AntiepilepticsPREVENTABILITYProbably preventable 14 1Not preventable 15 44Definitely preventable - -SEVERITYMILDLevel 1 6 9Level 2 - 23MODERATE - -Level 3 20 10Level 4(a) 2 3Level 4(b) 1 -SEVERE - -Level 5 - -Level 6 - -Level 7 - -The suspected ADRs were also classified using W.H.Opreferred terms. Ataxia (Carbamazapine and Phenytoin),somnolence (Divalproate Sodium, Carbamazapine,Phenytoin) dizziness (Carbamazapine, Phenytoin,Divalproate Sodium), tremors (Levitaracetam), euphoria(Phenobarbitone, Divalproate Sodium) rashes (Phenytoin,Clopidogrel), allergic reactions (Phenobarbitone, Phenytoin),gum hyperplasia (Phenytoin), urticaria (Phenytoin andAspirin), weight increase (Sodium Valproate), gastric ulcer(Gastric Ulcer), rash (Phenytoin, and Clopidogrel),angioedema (Clopidogrel), head ache (clopidogrel), andconstipation (Clopidogrel) were the adverse drug reactionsreported during the study with the antiepileptic and antiplatelet agents.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 21

Ramesh A - Prospective Monitoring and Reporting of Adverse Drug Reactions associated with Antiplatelet and Antiepileptic Drugs in a South Indian Tertiary Care Teaching HospitalA patient presented with anticonvulsant hypersensitivitysyndrome with the combined use of phenytoin andphenobarbitone. Causality association between drug andreaction was found probable in 73.33% (n=33) on WHO ADRprobability scale and 48.88% (n=22) on Naranjo's scalerespectively. Among antiplatelet agents, Aspirin was foundresponsible for 51.72% (n=15) and Clopidogrel was foundresponsible for 48.27% (n=14) of ADRs. Causalityassociation between drug and reaction was probable in62.06% (n=18) and 37.93% (n=11) as assessed by usingWHO probability scale and Naranjo's algorithm respectively.Causality association of adverse drug reaction with theantiepiletic medications and antiplatelet agents using causlityassesment algorithms is presented in Figure.1.Fig.1: Causality assessment of ADRs of anti epileptic agents(AEA) and Anti Platelet Agents (APA) using Naranjo's andWHO probability scalesAPA: Antiplatelet Agents,AEA: Anti Epileptic AgentsAfter development of an adverse drug reaction, antiepilepticmedications were discontinued in 13 cases and dose wasaltered in 5 cases. In antiplatelet group, medications werediscontinued in one case and dose was altered in 5 cases.Symptomatic treatment was given in 33 cases for ADRs suchas rash, urticaria, GI ulcer, and abnormal behaviour andspecific treatment such as use of tranexemic acid was given in11 cases for GI bleed due to aspirin. The ADRs werecontinued in 38 cases (51.31%) and 26 patients (35.13%)were recovered from ADRs. The details regarding thediscontinuation of the medication, symptomatic treatmentand outcomes of ADRs are presented in Table.3.DISCUSSIONAntiplatelet agents have demonstrated effective clinicaloutcomes in the management of post-acute myocardialTable 3: Action taken, treatment initiated and outcomesof the reported ADRsAnti Epileptic agents Anti Platelet agentsNumber Percentage Number Percentage(n=45) (%) (n=29) (%)Action TakenNo Change 27 60 23 79.3Dose Altered 05 11.11 05 17.2Discontinued 13 28.88 01 3.4Treatment InitiatedSpecific 10 22.22 01 03.44Symptomatic 15 33.33 18 62.06No Treatment 20 44.44 10 34.48Outcome of ADRContinued 21 46.66 17 58.60Recovered 20 44.44 06 20.70Unknown 04 08.88 06 20.70infarction (AMI), ischaemic stroke or transient ischaemicattack, and in patients with stable or unstable angina,peripheral arterial occlusive disease or atrial fibrillation and11reduce the risk by 25%. The pooled incidence rate of aspirininduced gastro intestinal hemorrage in meta analysis of 1411studies was found as 0.12% . In the present study, theincidence rate was found to be 0.9% which is close to thefindings of the meta analysis. Studies have also shown thatincidence rate will increase in elderly patients, people withprevious history of peptic ulcer disease, and use ofcoricosteroids and NSAIDs. In a study conducted by ShehabN et al mentioned that the risk of GI bleeding is very highwhen antiplatelet agents are given in combination as aspirin12with clopidogrel. The risk was estimated as 1.2:1000 inindividuals receiving dual antiplatelet therapy cautioning the13prescribers to be more vigilant. However antiplatelet agentsare known to pose risk to the patients by causing gastrointestinal hemorrhage, skin rashes, neutropenia and14cholestatic jaundice.Independent of the Anti Epileptic Drug use profile (eithermonotherapy or combination therapy) phenytoin (42.14%)was the most frequently prescribed AED followed by valproicacid (39.40%), carbamazepine (25.05%), phenobarbitone(16.62%), clobazam (14.12%) and miscellaneous AEDsinclude clonazepam, levetiracetam, oxcarbazepine etc(9.69%). In antiplatelet agents group, 83.53% patientsreceived dual antiplatelet therapy that is both Aspirin andClopidogrel and 16.47% patients received monotherapy.Number of ADRs involved with Phenytoin was 23 [Gumhyperplasia(9), somnolence(2), asthenia(1), ataxia(2),Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 22

Ramesh A - Prospective Monitoring and Reporting of Adverse Drug Reactions associated with Antiplatelet and Antiepileptic Drugs in a South Indian Tertiary Care Teaching Hospitalrash(3), fixed drug eruptions(1), dizziness(2), insomnia(1),somnolence(2)]. Valproic acid had caused 13 ADRs [weightincrease (5), abnormal behavior (2), fatigue (1), menstrualdisorder (1), dizziness (1), liver function test abnormality (1),somnolence (2)]. Carbamazepine had caused 4 ADRs [ataxia(2), dizziness (1), lethargy (1)]. Phenobarbitone had caused 2ADRs [abnormal behavior (1), gum hyperplasia (1)]. Tremorwas developed in one patient while increasing the dose ofLevetiracetam.Many research studies have corroborated the phenytoin may15,16cause the gingival hyperplasia. Despite having highincidence of gingival hyperplasia with phenytoin, patients arestill recommended with phenytoin because of economicconsiderations. Valproic acid is reported to cause weight17gain hepatic and renal damage, syndrome of inappropriateanti diuretic hormone hypersecretion (SIADH) in patients. Inour study, weight gain was observed in 5 patients. In suchcases, the strategy adopted to decrease the weight was dietcounseling and life style modifications to the patients.The ADRs involved with Aspirin use were Urticaria (6)Gastric ulcer (8) and gastrointestinal bleeding (1) and withClopidogrel use were Rash (4), Angioedema (2), Headache(3), and constipation (5).Among the ADRs developed by antiepileptic agents thehighly affected organ system class is Gastro intestinaldisorders followed by Central peripheral nervous systemdisorders. Among ADRs developed by antiplatelet agents thehighly affected organ system class is Gastro IntestinalDisorders followed by skin and appendages disorder.No change in the treatment was observed in 50 cases as thoseADRs were mild and self limiting in nature. Even thoughthere was no overdose situation among the study population,10 patients improved when dose was altered. Medicationswere discontinued in 14 patients as the ADRs were so severelike gastrointestinal bleeding, liver damage, anticonvulsanthypersensitivity syndrome etc.Majority of patients did not receive any treatment for theADRs because either these reaction were mild and selflimiting in nature or there is no specific or symptomatictreatment for some reactions. Also among few cases, patientswere not ready to withdraw the drug as the benefit from thedrug (phenytoin) was outweighing the risk and the alternativedrug was more costly than the existing one. As the studyduration was only for nine months we could able to reportonly few reactions. Long duration study will help us in findingthe incidence, prevalence, and predisposing factorsinfluencing the occurrence of ADRs.CONCLUSIONIn the present study, Phenytoin and Valproic acid attributed tomajority of adverse drug reactions in antiepileptic class.Aspirin attributed for majority of ADRs in antiplatelet class ofmedications. The organ system classes affected was centralnervous system (antiepileptic agents) Gastrointestinal system(Antiplatelet agents) and Skin (antiepileptic agents andAntiplatelet agents).ACKNOWLEDGEMENTWe sincerely thank the JSS University, Dr. H.G Shivakumar,Principal, and Dr. G Parthasarathi, Head, Department ofPharmacy Practice, JSS College of Pharmacy, Mysore andalso the Medical Superindent, JSS Hospital for theirencouragement and support.REFERENCES:1. International drug monitoring: the role of national centers.Report of a WHO meeting. World Health Organ Tech Rep Ser.1972;498:1-25.2. Michae DF, Gary SF. Adverse drug reactions in patients withcardiovascular diseases. Curr Probl Cardiol. 2008;33:703-768.3. Ramesh M. Drug therapy review. In: Parthasarathi G, NyfortHansen K, Nahata MC, Editors. A Textbook of ClinicalstPharmacy Practice- Essential Concepts and Skills: 1 ed.Chennai; Orient Longman Private Limited, 2004,p.218-2354. L.M Shish. Epidemiology and etiology of seizures and epilepsyin the elderly in Asia. Neurology Asia. 2004; 9(supplement1):31-32.5. Sridharan R. and Murthy B.N. Epilepsy. IBID.1999;40:631-6366. Vicky B.G, Hays R.D, Rausch R et.al. Quality of life of epilepsysurgery patients as compared with our patients withhypertension, Diabetes, Heart disease, and/or depressivesymptoms. Epilepsia.1994;35:597-607.7. Naranjo C.A, Busto U, Sellers EM. Comparision of twoalgorithms for assessing the probability of adverse drugreactions. Br J Clin Pharmacology.1982;13:223-227.8. Mayboom RH, Hekster YA, Egberts AC, Gribnau FW andEdwards IR. Causal or Casual, The role of causalityassessment in pharmacovigilance. Drug Saf. 1997;17(6):374-89.9. Hartwig SC, Siegel J, Schneider PJ. Preventability and severityassessment in reporting adverse drug reactions. Am J HospPharm 1992; 49: 2229-32.10. Shumock GT, Thornton JP, Witte WK. Comparison ofpharmacy-based concurrent surveillance and medical recordretrospective reporting of adverse drug reactions. Am J HospPharm. 1991;48:1974–6.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 23

Ramesh A - Prospective Monitoring and Reporting of Adverse Drug Reactions associated with Antiplatelet and Antiepileptic Drugs in a South Indian Tertiary Care Teaching Hospital11. Micha T, Wojciech. Role of antiplatelet drugs in the prevention ofcardiovascular events. Thrombotic Research. 2003;10(5):355-359.12. Shehab N, Sperling LS, Kegler SR, and Budnitz DS. Nationalestimates of emergency department visits for hemorrhagerelatedadverse events from clopidogrel plus aspirin and fromwarfarin. Arch Intern Med. 2010;170:1926-1933.13. Diener HC, Bogousslavsky J, Brass LM et al. Aspirin andclopidogrel compared with clopidogrel alone after recentischaemic stroke or transient ischaemic attack in high-riskpatients (MATCH): randomised, double-blind, placebocontrolledtrial. 2004. Lancet; 364 (9431): 331–7.14. Zakarija A, Bandarenko N, Pandey DK, et al.. Clopidogrel-Associated TTP An Update of Pharmacovigilance EffortsConducted by Independent Researchers, PharmaceuticalSuppliers, and the Food and Drug Administration. Stroke. 2004;35 (2): 533–8.15. Casetta I, Granieri E, Desiderá M, Monetti VC, Tola MR, PaolinoE, Govoni V, Calura G. Phenytoin-induced gingival overgrowth:a community-based cross-sectional study in Ferrara, Italy.Neuroepidemiology. 1997;16(6):296-303.16. Lucchesi JA, Cortelli SC, Rodrigues JA, Duarte PM. Severephenytoin-induced gingival enlargement associated withperiodontitis. Gen Dent. 2008. 56(2):199-203.17. J Egger and E M Brett. Effect of Sodium Valproate in 100children with reference to weight. BMJ.1981;283:577-581.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 24

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaPharmacoeconomic Analysis of Asthma in Pediatric Patients in Tertiary CareHospital in KeralaStejin J*, Kishor KV, Nandha KN, Srinivasan A, Arul PKC and Kannan SDepartment of Pharmacy Practice, JKKMMRF's - Annai JKK Sampoorani Ammal College of Pharmacy, Tamil nadu, India- 638 183A B S T R A C TSubmitted: 04/07/2012Accepted: 12/08/2012Bronchial asthma is the most common chronic disease of childhood, responsible for a significant proportion of the abstinence from school. Theobjective of our study was to determine the total direct and indirect cost of asthma in pediatrics. The study design was prospective observationalstudy. This study was carried out among the pediatrics aged (0-15), and a total of 158 patients were taken. A questionnaire is prepared based onGINA guidelines of asthma for data collection, the patients/caregivers are requested to answer the questionnaire. From 158 patients enrolled110(70%) were males and 48(30%) were females. The direct cost of asthma was found to be 88.59% and indirect cost was found to be 11.4%.This study shows that the direct cost was very high as compared to indirect cost. The medication cost was found to be high 46.10% of total costfollowed by hospitalization cost 30.14%. According to the degree of severity the moderate persistent asthma was found to be 39.49% of the totalcost of asthma. Study revealed that the asthma hospitalization can be decreased as the inhalation therapy use increased.Keywords: Asthma, Pharmacoeconomics, Direct cost, indirect costINTRODUCTIONBronchial asthma is the most common chronic disease ofchildhood. In recent years a consistent increase in theprevalence of asthma has been reported from various regions1of the world. Pediatric asthma accounts for a large proportionof childhood hospitalization, physician visit, absenteeismfrom school and parental absence from work. Numerousfactors affect the cost of childhood asthma, like diseaseseverity, under treatment, inadequate preventive drug use andinadequate medication regimens, exposure to environmentalagent and lack of education of patient's families and2caregivers. Prospective studies may be costly, take severalyears to complete, and require a sampling strategy that3ensures generalizability of the results. . Pharmacoeconomicstudies are crucial, as now many third-party payers, such asgovernment and private health-care plans, are requiring thesestudies to be performed in order to decide if they will4reimburse the claim . The social science ofpharmacoeconomics is quite a new and rapidly changingfield. The roots of pharmacoeconomics are in healtheconomics – specialised aspect of economics developed inthe1960s. The concepts involved in pharmacoeconomics,such as cost-effectiveness and cost-benefit analysis, havebeen developed from the late 1970s. Beginning in the 1980s,measurement tools for health and clinical outcomesAddress for Correspondence:Stejin Jacob, Department of Pharmacy Practice, JKKMMRF's - Annai JKKSampoorani Ammal College of Pharmacy, Tamil nadu, India- 638 183.E-mail: stejinjacob@gmail.comassessment were created and have subsequently been5improved . Pharmacoeconomics addresses both economicand humanistic outcomes. Pharmacoeconomics includesideas and methods from a variety of domains includingstatistics, clinical epidemiology, economics, decisionanalysis and psychometrics, etc. Pharmacoeconomics andoutcomes research are two related disciplines that focus onthese areas of investigation. The purpose of this study was toestimate the total direct and indirect cost of asthma in6pediatrics .MATERIALS AND METHODSPatient sampleThe study population consisted of any patient diagnosed withasthma as a primary disorder. The sampling was designed toinclude both in-patient and out-patient departments of tertiarycare hospital in kerala.The project received ethics approval,and participants provided written informed consent. Themethod used was the prospective observational study. Thisstudy focused on 158 pediatric patients aged between 0-15years, pediatric patients with asthma or symptoms of asthma,in-patient and out-patient asthma patients are included in thisstudy and patients with other chronic conditions, patientsadmitted in ICU are excluded from the study. The study wascarried out for a period of 10 months from June 2011 toMarch 2012.Data collectionQuestionnaire is prepared based on the GINA, GOLDENguidelines of asthma for data collection. Thepatients/caregivers were requested to answer theIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 25

Stejin J - Pharmacoeconomic Analysis of Asthma in Pediatric Patients in Tertiary Care Hospital in Keralaquestionnaire which includes the demographical data of thepatients. Parents were requested to answer about theiroccupation, monthly income, contact address and contactphone number. At the end of one month, the patients wererecalled by telephonic interviews and collected informationabout child's health. Telephonic interviews were conducted at1, 3, 6 months after registration during which questions wererepeated and information from the parents was collectedduring the subsequent months. The telephonic interviewswere coded and framed to concentrate specifically onrespiratory-related resource use. Health services reportingconsisted of respiratory-related visit to general practitioner,pulmonologist, pediatrics, emergency department, hospitaladmission, medication cost and travelling costs. All theinterviews with parents were conducted in the presence ofchildren who supplied information that the parents wereunable to provide (severity of symptoms).Time to completethe questionnaire was usually between 15-20 minutes.Cost measurementThe total costs for asthma were divided into direct andindirect costs. Costs were calculated by multiplying asthmarelated utilization by the unit cost. Since the true value ofresource consumed is not available for most services andproducts, prices and fees were used. Direct medical costsconsists of asthma related health services, privately insuredcomplementary care, prescription medication and physiciancost. Direct patient costs were out of pocket expenses relatedto asthma care. Indirect cost consisted of parent productivitylosses resulting from disease related child care, and travel andwaiting time. The total cost for each medication wascalculated by multiplying the estimated annual number ofprescriptions by the cost per prescription. Indirect cost wasmeasured by multiplying the total time loss by the parentsreported salary.Statistical analysisOne-way anova method was used to explore the impact ofexplanatory variables on costs. These variables includemedication cost, patient age, gender, parent occupation anddisease severity. One way anova method determined whichvariables were statistically significant predictors of costs,using a p-value of 0.05 or less.RESULTSTable 1 shows the prevalence of asthma according to gender.Out of 158 pediatrics, 110 were found to be male and 48 werefemale patients. The education grades of the patient showsthat, most of the patients are comes under pre-high schoolrange, and the weight distribution shows that the patientsunder age 10 years was found to be most affected.Table 2 shows that most of the patients have mild persistentasthma and most of the patients are atopic. 41.77% patientsTabl 1: Prevalence of asthma according to sexSex Number of Patients Percentage (%)Male 110 70%Female 48 30%Frequency (n=158)Table 2: Characteristics of populationCharacteristics Number of patients Percentage (%)Age in years0-5 54 34.5%5-10 68 43.0%10-15 36 22.5%Family income one monthBelow 5000 24 15.18%Between 5000-7500 60 37.97%Between 7500-10,000 42 26.58%Above 10,000 32 20.25%Disease severityMild intermittent 58 36.70%Mild persistent 62 39.24%Moderate or severe 38 24.05%Co morbid diseaseAllergic rhinitis 46 29.11%Mothers asthma 09 05.69%Atopic dermatitis 03 00.01%Atopy 66 41.77%Frequency (n=158)are atopic shows that allergy is the main cause for paediatricasthma. Family income of the patients shows that most of thefamilies belonged to middle class and their monthly incomewas below Rs.10,000/-. The present study shows that the mostcommon clinical manifestation of paediatric asthma wasfound to be shortness of breath. 65.82% of total patient showsshortness of breath, followed by 59.49% patients experiencedcough. Out of 158 patients, 102 received monotherapy and 56got combination therapy, because most of the patients hadmild persistent asthma. The male were more prone tocombination therapy as compared to females. As mentionedearly that the males are more prone to asthma as compared tofemale. The ratio of monotherapy to combination therapy inmale was found to be 2:1 and in female patients, it was almost1:1. This shows that the male are more prone to drug therapyas compared to female. When taken into account ofantiasthmatic drug only, the highest percentage of cost was forinhaled corticosteroids (31.70%), followed by inhaledbronchodilators (29.51%) and leukotrine antagonists(25.19%). The most commonly used drug was found to be oralIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 26

Stejin J - Pharmacoeconomic Analysis of Asthma in Pediatric Patients in Tertiary Care Hospital in Keralabronchodilator, because it is less expensive and effectiveagainst asthma. Present study shows that inhaledcorticosteroids (23.93%) were found to be the highestpercentage cost followed by antibiotics (23.46%). The studyshows that despite the highest cost of inhalation drugs,prescribers frequently used the inhalation drugs due to theireffectiveness. The highest cost of these inhalation drugs ismainly due to the prescription of these drugs for 3, 6 monthsor for 1 year.Table 3 shows the utilisation of common drug for asthma. Thehighest mean consumption of drug was found to be inhaledcorticosteroid 1495.90 ± 7.03 followed by inhaledbronchodilator 1445.09 ± 5.04.Table 4 shows that direct cost of asthma in paediatrics. Thehighest percentage cost was found to be medication cost;almost half of the cost was found to be medication cost andfollowed by hospitalisation cost accounts for 30.14% of thetotal cost. The mean consumption cost was found to be high incase of hospitalisation.Table 5 shows the indirect cost of asthma. Parent work losswas found to be the highest percentage cost (43.80%),followed by the absence from school (39.81%). This studyshows that the direct cost is very high as compared to theindirect cost. The present study shows that the direct cost isalmost 8 times greater than the indirect cost. According to theage wise cost of asthma the paediatrics aged between 5-10years accounts for 44.24% of total cost of asthma. Thechildren aged between 5-10 years are more prone to asthmaand aggressive therapies like inhalation therapy and therapywith leukotrine antagonist increases the cost of asthma. Thishigh cost is mainly due to drugs and hospitalization.Table 6 shows the cost of asthma by severity of disease. Thehighest percentage cost was found to be the moderatepersistent asthma with 39.98% of total cost, followed bysevere asthma with 34.89% of total cost. The costs of asthmafor patient with moderate disease were almost twice as high asTable 4: Direct cost of asthmaDirect cost Percentage Mean±SD P ValueMedication cost 46.10% 2137.62 ± 7.37 0.0001**Hospitalization++ 30.14% 2505.59±4.30 0.0025*G.P visit 10.12% 515.52±69.58 0.0001**Clinic visit 01.98% 487.66±7.145 0.0655Home care 00.96% 176.37±6.42 0.0587Emergency visit+ 06.05% 1136.92±25.77 0.0001**Diagnostic test 04.18% 547.20±14.4 30.0001**Ambulance service 00.43% 177.11±3.56 0.10n= number of patients, +Mean cost of emergency visit (n=39),++Mean cost of hospital admission (n=88), *p value0.05 are significant, **p value 0.0001 are extremely significantTable 5: Indirect cost of asthmaIndirect cost Percentage Cost (%) Mean±SD P valueTravelling 11.91% 84.83±58.83 0.0001**Work loss 43.80% 119.85±7.25 0.0001**School Absentee 39.81% 73.79±3.16 0.10Out of pocket 4.45% 32.01±14.72 0.0001**Data's are available in mean± SD, *p value 0.05 are significant,**p value 0.0001 are extremely significantfor mild asthmatic patients. The mean cost consumption wasfound to be high in severe asthma. Table 6 shows that there is arelationship between severity of disease and increases in boththe direct and indirect cost of asthma. This table also showsthat as the severity increases the mean consumption cost ofasthma also increased.Table 7 shows the direct cost of asthma by severity of illness.This table shows that the mean consumption of direct costwas very high for severe asthma as compared to mild andmoderate asthma. High mean consumption cost is forhospitalization 2505.59 ± 4.30; followed by drug cost2137.62 ± 7.37. The difference in drug cost between patientswith mild and severe asthma was probably because ofTable 3: Utilisation of common drug for asthmaDrugs Number of patients Mean±SD Percentage Cost (%) PvalueAntibiotics 72 1110±9.19 23.46% 0.0001**Corticosteroid oral 70 245.64±4.23 05.11% 0.0001**Bronchodilator oral 98 103.49±4.00 03.00% 0.0031*Leukotrine antagonist 46 1396±6.44 19.01% 0.0194*Antihistamine 10 720±23.57 02.13% 0.01Inhaled bronchodilator 52 1445.09±5.04 22.27% 0.0231*Inhaled corticosteroid 54 1495.90±7.03 23.93% 0.0005*Analgesic 30 117±3.308 01.04% 0.01Data's are available as mean± SD, *p value 0.05 are significant, **p value 0.0001 are extremely significantIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 27

Stejin J - Pharmacoeconomic Analysis of Asthma in Pediatric Patients in Tertiary Care Hospital in KeralaTable 6: Total cost of asthma by severity of illnessDegree of severity Direct cost(%) Indirect cost(%) Total cost(%)Mild intermittent (n=58) 1,87,550(25.62%) 19,956 (21.19%) 2,07,506(25.12%)Moderate persistent (n=62) 3,00,200(41.1%) 30,100 (31.96%) 3,30,300(39.98%)Severe (n=38) 2,44,100(33.35%) 44,120 (46.84%) 2,88,220(34.89%)Total (n=158) 7,31,850 94,176 8,26,020n= number of patient, Data's available in rupees,Table 7: Direct cost of asthma by severity of illnessCost provided Mild intermittent (n=58) Moderate persistent(n=62) Severe (n=38) Total P valueDrugs 1433.74 ± 306.13 1934.20 ± 9.79 3314.94 ± 521.55 2137.62 ± 7.37 0.0001**Hospitalisation 1132.56 ± 8.09 3207.66 ± 159.22 4221.05 ± 4.057 2505.59 ± 4.30 0.0025*G.P visit 346.55 ± 24.20 457.41 ± 17.20 674.73 ± 32.20 515.52 ± 69.38 0.0001**Clinic visit 183.33 ± 4.02 630.01 ± 7.58 757.5 ± 9.10 487.66 ± 7.145 0.0655Home care 92.85 ± 1.02 212.50 ± 6.10 230.0 ± 2.23 176.37 ± 6.42 0.0587Emergency visit 472.0 ± 14.32 1225.26 ± 28.22 1634.0 ± 34.10 1136.92 ± 4.51 0.0001**Diagnosis 675,10 ± 5.34 555.21 ± 7.52 235.71 ± 2.24 547.20 ± 14.43 0.0001**Ambulance 101.20 ± 1.14 195.10±7.34 228.24 ± 14.32 177.11 ± 3.56 0.01n= number of patients, Data's are available in mean±SD, *p value 0.05 are significant, **p value 0.0001 are extremely significantinhalation drugs. The mean consumption cost for hospitaladmission in severe asthma was almost thrice as compared tomoderate asthma, which shows that the patient admission washigher in case of severe asthma.DiscussionCost analysis is an inexact science. Bothmeasurement error and methodological disagreementintroduce uncertainty into the estimates. Imprecision orinconsistency in the definition of asthma may affectquestionnaire data, medical data and dispensing data. Finallydisagreement about costing methods, particularly methods ofdetermining indirect costs, makes it difficult to compareestimates from different cost-analysis studies.This study differs from recently published studies of the costof asthma in several important ways. First this study was morecomplete, the cost associated with travelling time and schoolabsences are included in this study. Study also included costassociated with ambulance service and outpatient diagnosticservice.This study attempted to estimate the cost of pediatric asthmain a tertiary care hospital in Kerala showed that the total costof asthma for 9 months was found to be Rs.8,26,020 lakhs,which accounts for 16% of the 9 month income of a family.The majority of cost comes from medication cost (46.10%)and hospital admission cost (30.30%). The predictors of costof childhood asthma appeared to be disease severity, currentuse of preventive drug and having current use of emergencycare or current hospitalization. These findings provideinsights into the cost of pediatric asthma and may hopefullydirect policy decision towards a better management of thedisease.In this study, the mean cost of hospital admission was found tobe Rs.2505.59 ± 4.30.The hospital admission cost andmedication cost accounts for the 77% of the total direct cost ofasthma. Direct cost is far away as compared to the indirectcost. Direct cost for asthma accounts for approximately 7times more than that of indirect cost of asthma.The patients in the present study were treated according tobest practice by their primary care practitioner who followedinternational recommendations, and they were also assessedexpertly and regularly. However, effective asthma controlreduces cost particularly by decreasing hospitalization. Weisset al recently pointed out that, ”the number of hospitalizationswill fall when national treatment guidelines are followed”,and cost of asthma are, “largely due to uncontrolled disease,indicating that current therapies are either underused or7misused in practice .Fleisher et al., found that in early childhood, asthma is morecommon among males, but after puberty the incidenceincreases in females and decreases in male. In addition,8asthma after childhood is more severe in female than in male.Our study also confirmed that the male are more prone toasthma. This study shows that the bronchodilators andcorticosteroids for inhalation were the drugs used more oftenand accounted for 90% of all drug cost in patients. Buxton etIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 28

Stejin J - Pharmacoeconomic Analysis of Asthma in Pediatric Patients in Tertiary Care Hospital in Keralaal, showed that salbutamol was more cost effective than9formeterol because of its lower acquisition cost. Our studyalso revealed that salbutamol was the most commonlyprescribed drug for pediatric asthma.Krahn et al, showed that increase use of more expensivecombination inhalers have likely contributed to the rising10costs of asthma medications in recent years. Smith et al.,showed that recent data suggest that inhaled beta agonists are11the most frequently used medication , it is expected that thetherapy patterns have shifted towards greater use of inhaledcorticosteroids. This study shows that drugs cost makesapproximately 37% of total direct cost of asthma, andrepresents the major cost for mild-to-moderate asthmaticpatients. More aggressive therapy with inhaledcorticosteroids, inhaled bronchodilators and new therapiessuch as leukotrine antagonist may cause shifting of highmedication cost. Hospital cost is mainly incurred by patientswith moderate to severe asthma, and hospitalization usuallyoccurs when the management of asthma failed to prevent anacute attack, which is expensive to rectify. This study showsthat the cost of one admission to hospital pays for 3 years oftreatment with the inhaled corticosteroids.This study alsoshows that children accounted for a high percentage ofindirect cost, reflecting the importance of time spent by othersto care for children. Our study also reported that indirect costaccounts for almost 12% of the total direct cost of asthma.Indirect cost depends on the patient age and severity ofdisease. The costs of asthma for patient with moderate diseasewere almost twice as high as for mild asthmatic patients. Themean cost consumption was found to be high in severeasthma. This study shows that there is a relationship betweenseverity of disease and increases in both the direct and indirectcost of asthma. This study concluded that as the severityincreases the mean consumption cost of asthma alsoincreased. Mean consumption cost for severe asthma wasfound to be almost thrice as compared to moderate asthma.The drug cost and hospitalization cost was found to be high.The differences in the drug cost between patients with mildand severe asthma were probably because of inhalation drugs.CONCLUSIONThis study revealed the burden of direct cost on the patient'sfamily and on society. For a disease for which effectiveprophylactic therapies exist, much of the cost of asthmarelates to cost which could be avoided or reduced byimproved disease control. Indirect cost is incurred when thedisease is not fully controlled. Direct costs, are amendable toreduction by improved disease control. Study revealed thatthe asthma hospitalization can be decreased as inhalationtherapy use increased. Inhalation drugs can be usedindividually by the patients at home, so the travelling cost, GPvisit cost can be minimized and as a result hospitalization canalso be reduced. Patient education programs showedreduction in hospitalizations, GP visits, emergencyadmissions, and time of work and school and the monetarysavings have always been reported. It is necessary toemphasize the importance of appropriate management of thedisease, with the use of effective continued treatment inaccordance with the level of severity. The patients withmoderate asthma can be treated with monotherpy and in caseof severe disease the combination therapy is required. Thisapproach would probably improve patients quality of life,decreases the number and severity of attacks, and minimizethe cost of asthma.ACKNOWLEDGMENTSThe authors would like to thank Dr.S.Sabarinath, Medicalsuperintendent of the hospital for the help during theconceptual preparation of this study and the guide whohelped in various stages of data collection.REFERENCE1. Sennhauser FH, Braun-Fahrländer C, Wildhaber JH. Theburden of asthma in children: a European perspective. PaediatrRespir Rev 2005; 6(1):2-7.2. Barnes P J, Jonsson B, Klim J B. The costs of asthma. EurRespir J 1996; 9:636–42.3. Freund D, Dittus R. Principles of Pharmacoeconomic Analysisof Drug Therapy. PharmacoEconomics 1992; 1(1):20–31.4. Glynn D. Reimbursement for New Health Technologies:Breakthrough Pharmaceuticals as a 20th Century Challenge.Pharmacoeconomics 2000; 18 (S1):59–67.5. Wilson E A. De-Mystifying Pharmacoeconomics. Drug BenefitTrends 1999; 11(5):56–58, 61–62, 67.6. Belien P. Healthcare systems, A New European Model?.PharmacoEconomics 2000; 18(S1):85–93.7. Weiss K B, Sullivan S D. Understanding the costs of asthma:the next step. CMAJ 1996; 154:841-3.8. Fleisher B, Kulovich M V, Hallman M, Gluck L. Lung profile: sexdifferences in normal pregnancy. Obstet Gynecol 1985;66(3):327-30.9. Sculpher Mark J, Buxton Martin J. The Episode-Free Day as aComposite Measure of Effectiveness: An Illustrative EconomicEvaluation of Formoterol Versus Salbutamol in AsthmaTherapy. Pharmacoeconomics 1993; 4(5):345-52.10. Krahn M D, Berka C, Langlois P and Detsky A S. Direct andindirect costs of asthma in Canada, 1990. Canadian MedicalAssociation Journal 1996;154(6):821-31.11. David HS, Daniel CM, Kenneth AL, Lynn JO, Carmelina B,William BS. A National Estimate of the Economic Costs ofAsthma. Am J Respir Crit Care Med 1997; 156:787–93.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 29

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaA Retrospective Evaluation of the use of Thiazolidinediones in Patients with Diabetes Mellitus ina Private Hospital in Ras Al Khaimah.1 2 3 4Smitha F* , Padma R , Multani SK and Meenakshi J1, 2 Department of Pharmacy Practice, RAK College of Pharmaceutical Sciences, RAK Medical and Health Sciences University, Ras Al Khaimah,UAE.3Endocrinologist, Al Zahrawi Hospital. Ras Al Khaimah, UAE.4Department of Pathology, RAK College of Medical Sciences, RAK Medical and Health Sciences University, Ras Al Khaimah, UAE.A B S T R A C TSubmitted: 24/07/2012Accepted: 14/08/2012Diabetes Mellitus is a major public health problem affecting around 800,000 people of United Arab Emirates (about 19.2 per cent of thethpopulation). Thus the country is ranked as the 10 worldwide in terms of highest prevalence rate as per the latest reports of the InternationalDiabetes Federation. Thiazolidinediones (Rosiglitazone and Pioglitazone) are a group of antidiabetic drugs which are commonly used in UnitedArab Emirates among diabetic patients. There are reports about the cardiovascular risks and hepatotoxic effects of thiazolidinediones. Hence thepresent study was undertaken. The aim of the study was to determine the incidence of thiazolidinedione usage, its adverse drug reactions,efficacy and safety in diabetic patients. The present study was undertaken after the approval of the Research and Ethics Committee of RAKMedical and Health Sciences University. This was a retrospective study conducted in the outpatient clinic of the Department of Endocrinology andDiabetes of a private hospital in Ras Al Khaimah, United Arab Emirates, between January to December 2008. The required data was collectedfrom the selected patients and entered into specific patient proforma. The data was analyzed for the following parameters like incidence of usageof thiazolidinediones, its efficacy and adverse drug reactions. A total of 143 patients with diabetes were enrolled in the study, out of which 54patients were on Thiazolidinediones- 48 on Rosiglitazone and 6 on Pioglitazone- in the beginning of the study. At the end, 73 patients were onRosiglitazone and 17 were on Pioglitazone. The most commonly observed adverse effect was pedal edema. No cardiovascular risks wereobserved in any of the patients who were on either Rosiglitazone or Pioglitazone. Though there are reports of cardiovascular risks withThiazolidinediones, throughout our study, none of the patients reported any cardiovascular risk.Keywords: Diabetes Mellitus, Thiazolidinediones, Adverse drug reactions, Utilization evaluation.INTRODUCTIONDiabetes mellitus is the most common of the endocrinedisorders. It is a chronic condition, characterized byhyperglycemia due to impaired insulin secretion with or1without insulin resistance . It is being recognized as a globalepidemic, with the potential to cause a worldwide healthcarecrisis. It is estimated that currently diabetes affects some 200million people worldwide. According to estimates by theInternational Diabetes Federation, this figure is set to increase2to 333 million by the year 2025 .3Diabetes is a major public health problem in UAE . Surveysreleased by the International Diabetic Federation (IDF) in theyear 2011, showed that 19.2 % or 800,000 -people in theUAE live with diabetes leading to UAE being ranked as theAddress for Correspondence:Smitha C Francis, Department of Pharmacy Practice, RAK College ofPharmaceutical Sciences, RAK Medical and Health Sciences University,P O Box11172 Ras Al Khaimah, UAE.E-Mail: smithafrancis2003@yahoo.co.inth10 worldwide in terms of highest prevalence rate. It has beenreported that 17.9% nationals and 13.4% expatriates are4affected with this condition in UAE .Type 2 diabetes patients, due to their progressive beta cellfunction and increasing insulin resistance usually require twoor three drugs to maintain control before ultimately requiringinsulin. Thiazolidinediones (TZDs) have established a5significant role in Type 2 diabetes mellitus therapy . They areknown to increase insulin sensitivity by stimulatingPeroxisome Proliferator Activated Receptor Gamma (PPARγ).Currently only one glitazone, i.e. pioglitazone is availablein the UAE market following the removal of rosiglitazone in62010 .There have been several studies reporting the cardiovascular7, 8risks associated with thiazolidinediones .Studies related to these are lacking in the UAE population.More studies are required to know the adverse effects of thesemedications for a proper and safe usage as these arefrequently prescribed to patients. Hence, the present studywas undertaken.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 30

Smitha F - A Retrospective Evaluation of the Use of Thiazolidinediones in Patients with Diabetes Mellitus in a Private Hospital in Ras Al Khaimah.The main objectives of this study were to find outŸ The incidence of usage of Thiazolidinediones in diabeticpatientsŸ The incidence of cardiovascular and hepatic adverseeffects with the use of ThiazolidinedionesŸ To compare the efficacy and safety of the commonly usedThiazolidinediones in UAE.MATERIALS AND METHODSStudy site:The study was carried out at the Endocrine department of asecondary care hospital in Ras al Khaimah, UAE.Study duration:Duration of the study was for one year ranging betweenJanuary to December 2008.Study type:This was a retrospective study.Study material:Data collection form was prepared to enter the details of thepatients enrolled in the study. (Appendix)Study method:The study protocol was approved by the RAK Medical andHealth Sciences University, Ethics Committee, Approvalthletter dated 25 June, 2009. All the diabetic patients whovisited the outpatient department of the hospital for treatmentduring the study period were included in the study.The data was evaluated forØ Incidence of usage of thiazolidinedionesØ Adverse effects associated with the use ofthiazolidinedionesØ Comparison of the different thiazolidinediones for theirsafety and efficacyRESULTSTotal number of diabetic patients included in the study was143. In the beginning of the study, 54 patients were onThiazolidinediones of which 48 were on rosiglitazone and 6on pioglitazone. At the end of the study, 73 patients were onrosiglitazone and 17 were on pioglitazone (fig. 1). At thebeginning of the study 18 patients were on rosiglitazone andmetformin combination and 30 patients were on Metforminand Sulphonylureas (Glibenclamide, Glimepride, Gliclazide)combination along with rosiglitazone. At the end of the study,27 patients were on rosiglitazone and metformincombination. There were 34 patients with a combination ofrosiglitazone , metformin and Sulphonylureas(Glibenclamide, Glimepride,Gliclazide) and 12 patients on acombination of rosiglitazone with Metformin,Sulphonylureas and Dipeptidyl Peptidase-4 Inhibitors(DPP4I) (fig.2).At the beginning of the study, there was 1 patient onPioglitazone, 2 on combination with metformin and 3 patientson a combination of pioglitazone, Metformin andSulphonylureas .At the end of the study, there was 1 patient onPioglitazone, 6 on combination with metformin ,7 patients ona combination of pioglitazone, metformin andSulphonylureas (Glibenclamide, Glimepride, Gliclazide )and 3 patients on a combination of pioglitazone, Metformin,Sulphonylureas and DPP4I (fig. 3).Both the Thiazolidinediones were well tolerated by all thepatients except one who developed pedal edema and facialpuffiness with the use of Rosiglitazone and the drug waswithdrawn. No other cardiovascular adverse effects wereobserved in any of the patients who were on eitherFig.1: Type of Thiazolidinediones prescribedNo. of Patient4035302520155054Rosiglitazone187330InitialFinalFig.2: Combination Therapy-RosigkitazoneNo. of Patient106PioglitazoneInitialFinalRosi+Met Rosi+Met+SU Rosi+Met+SU+DPP4IFig.3: Combination Therapy-PioglitazoneNo. of Patient86420123 3Pioglitazone Pio+Met Pio+Met+SU Pio+Met+SU+DPP4273412Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 31

Smitha F - A Retrospective Evaluation of the Use of Thiazolidinediones in Patients with Diabetes Mellitus in a Private Hospital in Ras Al Khaimah.Rosiglitazone or Pioglitazone. The hepatic transaminases ofthe patients before and towards the end of the study werewithin the normal range (Table 1). Efficacy wiseRosiglitazone was able to bring down the HbA1c % comparedto Pioglitazone (Table 2).Table1: Hepatic Adverse drug reactions of ThiazolidinedionesPARAMETER ROSIGLITAZONE PIOGLITAZONEALT (SGPT) IU/LInitial 39.06 ±25.75 (n - 84) 46.61±39.78 (-15)6 Months 39.91 ±24.45 (n - 45) 40.42±31.69 (-11)AST (SGOT ) IU/LInitial 31.52±17.17 (n-31) 32.91±30.40 (n-8)6 Months 32.67±21.10 (n-11) 22.55±2.89 (n-2)ALT- Alanine aminotransferase, SGPT- serum glutamic pyruvictransaminase , AST- Aspartate amino transferase,SGOT- serum glutamic oxaloacetic transaminaseTable2: Safety and Efficacy of ThiazolidinedionesPARAMETER ROSIGLITAZONE PIOGLITAZONEHbA1c %– Initial 7.82±1.94 7.66±1.56At the End 6.92±0.99 7.74±1.86FBSInitial 168.72±55.33 188.26±67.47At the End 142.84±34.71 142.93±13.29HbA1c- Glycated hemoglobin, FBS- Fasting blood sugarDISCUSSIONThe present study was aimed to find the incidence of use ofThiazolidinediones, any association of cardiovascular andhepatic risks and comparison of the efficacy and safety ofdifferent thiazolidinediones. It was observed during the studythat majority of the patients were on rosiglitazone (n=73)compared to pioglitazone(n=17). A study conducted byBalkrishnan R comparing Rosiglitazone and Pioglitazonemonotherapy has reported that introduction of rosiglitazonewas associated with a decreased number of hospitalizations,emergency department visits, and total health care costs8compared with pioglitazone . In majority of the patients in ourstudy, the thiazolidinediones were used in combination withother antidiabetic medications and it was found thatrosiglitazone was more effective in bringing down the HbA1cvalues when compared to pioglitazone when these drugs wereused in combination with other antidiabetic drugs.Nocardiovascular adverse events were observed in any of thepatients. This could be related to the lower dose of drugs used(2-4 mg for rosiglitazone and 15-30 mg for pioglitazone) ordue to the rational or appropriate usage of the drugs. Duringthe study one patient developed pedal edema and facialpuffiness with use of Rosiglitazone. Our findings support thestudy by Mudaliar S, who has also found that bothpioglitazone and rosiglitazone have been associated withdevelopment of edema. The incidence of edema in these trialsvaried from 3.0 to 7.5% with the thiazolidinedionescompared with 1.0 to 2.5% with placebo or other oralantidiabetic therapy. Available evidence suggests that edemais a class effect of the thiazolidinediones and is multifactorial9in origin . The study by Richard WN also supports ourfindings regarding edema with usage of thiazolidinediones.According to this study, the incidence of edema was 4.8% inthe rosiglitazone group compared with 1.3% on placebo.When combined with metformin or sulfonylurea, edema wasobserved in 3 to 4% of patients compared with 1.1 to 2.2% oneither comparator drug alone. These data suggest that edemais a side effect of the TZD drugs to a similar degree, eitherwhen used as monotherapy or when combined with other oral10antidiabetes agents .There were no significant hepatic adverse effects in any of thepatients who were on Thiazolidinediones-neitherRosiglitazone nor Pioglitazone. Their liver enzymes werewithin normal range (Table 4). Our study thus is in agreementwith study by Harold E L who stated that no evidence ofhepatotoxic effects was observed in studies that involved5,006 patients taking rosiglitazone as monotherapy orcombination therapy for 5,508 person years. This is inkeeping with hepatic data from clinical trials of another11member of the class, pioglitazone .Only a few case reports ofhepatotoxicity have been reported in patients treated withrosiglitazone until now, with a causal relationship remaininguncertain. Furthermore, no single case of severe12hepatotoxicity has been reported yet with pioglitazone .The present study showed a better efficacy with rosiglitazone(Table 2) in reducing HbA1c %. This finding was in contrastto the report of Ronald et al where both the glitazones showedsimilar efficacy. A study showed that rosiglitazone 8 mg dailyand pioglitazone 45 mg daily brought about 1.5%improvement in HbA1c %, after 6 months of treatment. Theglycemic lowering effect of these agents is slightly less thanthat reported with sulphonylureas or metformin, yet the13durability of glycemic control is superior . Pioglitazoneshowed better improvement in the FBS levels of the patientscompared to Rosiglitazone. But the number of patients whowere on Pioglitazone was comparatively less.CONCLUSIONOur study concludes that thiazolidinediones were welltolerated in almost all the patients who were enrolled in theIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 32

Smitha F - A Retrospective Evaluation of the Use of Thiazolidinediones in Patients with Diabetes Mellitus in a Private Hospital in Ras Al Khaimah.study. There were no major cardiovascular or hepatic adverseeffects observed during the study except one patient whodeveloped edema which was reversible. Since there arereports on the cardiovascular and hepatic adverse effects ofthese drugs , a close monitoring of the patients is essential.Though there are many other ADRs which are common toThiazolidinediones like weight gain and anaemia, we did notobserve such ADRs in our study. This is an area which is stillof concern among clinicians and other healthcareprofessionals since reporting of ADRs is very important. Asthe drug rosiglitazone has been banned from the UAE market,a study on pioglitazones for its adverse drug reactions can bedone in a wider population. Since the study was done in aprivate hospital where majority of the patients wereexpatriates, a similar study can be conducted in the nationalpopulation receiving these medications since diabetesprevalence is more in them compared to expatriates.AppendixRAK Medical & Health Sciences UniversityData collection formName of the hospital :Name of the treating doctor :File number :Contact no :Ethnicity :Occupation :Age :Sex :Duration of diabetes :Age of onset :Family history of diabetes :Height :Weight :BMI :WC :BP :Marital status :Lifestyle factors : sedentary/activeExercise :Diet: veg/ non-vegSmoking :Alcohol :Co-morbidities :DIAGNOSIS: …………………………………………………………………………………Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 33

Smitha F - A Retrospective Evaluation of the Use of Thiazolidinediones in Patients with Diabetes Mellitus in a Private Hospital in Ras Al Khaimah.Investigations: 0 2 4 6 8 10 12FBSPPBSHbA1cSGOTSGPTUric acidCreatinineUreaTotal CholesterolTriglyceridesHDLLDLHDL/LDLCPKElectrolyte KNaHemoglobinUrine Micral A/C ratioAny other additional investigationsTreatment:DiabetesHypertensionDyslipidemiaOthersIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 34

Smitha F - A Retrospective Evaluation of the Use of Thiazolidinediones in Patients with Diabetes Mellitus in a Private Hospital in Ras Al Khaimah.ACKNOWLEDGEMENTSWe are thankful to the Director and Staff, Al Zahrawi Hospitalfor all the help extended in carrying out the present study. Wealso express our sincere gratitude to the Vice chancellor, RAKMedical and Health Sciences University and the Dean, RAKCollege of Pharmaceutical Sciences, RAK Medical andHealth Sciences University for providing us all the facilitiesand the support for the successful completion of our study.REFERENCES:1. Elizabeth AH, and Stephan NJJ. Diabetes Mellitus. In: Roger Wand Cate W. Clinical Pharmacy and Therapeutics. fifthedition.UK: Churchill livingstone Elsevier; 2012:685.2. Jane B. Global Diabetes (online).2011(cited 2011 March)Available from: URL:http://www.diabetes.co.uk/globaldiabetes/index.html3. Fatma A M, Mohammed E S and John N N The prevalence ofmacrovascular complications among diabetic patients in theUnited Arab Emirates Cardiovascular Diabetology 2007,6:24Available from: http://www.cardiab.com/content/6/1/244. Dr. Mahmoud Fikri The Magnitude of Diabetes in UAE NationalDiabetes Strategy and achievements Understanding andconfronting diabetes Available from http://www.menadiabetesleadershipforum.com/presentations/MENADLF-Day1.5. John JJ , Susan C and William EW. Diabets Mellitus. In: MarieACB, Terry LS,Barbara GW,Patrick MM, Jill MK and Joseph TD.Pharmacotherapy Principles and Practice second Edition.US.Mc Graw Hill companies Inc; 2010: 7356. Megan D. Diabetes drug Avandia to be banned (online).2010(cited 2010 september 27) Available from : URL:http://www.thenational.ae/news/uae-news/health/diabetesdrug-avandia-to-be-banned7. Sanjay K, Ann FB, David H, Robert PG, and Robert H.Thiazolidinedione Drugs and Cardiovascular Risks: A ScienceAdvisory From Foundation of the American Heart Associationand American College of Cardiology Am. Coll. Cardiol.2010;55;1885-94.8. Simó R, Rodriguez A, Caveda E. Different effects ofthiazolidinediones on cardiovascular risk in patients with type 2diabetes mellitus: pioglitazone versus rosiglitazone. Curr DrugSaf. 2010 Jul 2;5(3):234-449. Balkrishnan R, Arondekar BV, Camacho FT, Shenolikar RA,Horblyuk R, Anderson RT. Comparisons of rosiglitazone versuspioglitazone monotherapy introduction and associated healthcare utilization in Medicaid-enrolled patients with type 2 diabetesmellitus. Clin Ther. 2007 Jun;29(6 Pt 1):1306-15.10. Mudaliar S, Chang AR, Henry RR.Thiazolidinediones,peripheral edema, and type 2 diabetes: incidence,pathophysiology, and clinical implications. Endocr Pract. 2003Sep-Oct;9(5):406-16.11. Richard W. N, David B, Robert O. B, Vivian F, Scott M. G, EdwardS. H, Martin L W, Daniel P et al Thiazolidinedione Use, FluidRetention, and Congestive Heart Failure A ConsensusStatement From the American Heart Association and AmericanDiabetes AssociationAvailable from http://circ.ahajournals.org12. Harold E. L, Margaret K, Martin I. F, Evaluation of Liver Functionin Type 2 Diabetic Patients During Clinical Trials Evidence thatrosiglitazone does not cause hepatic dysfunction. DiabetesCare, 25( 5), 200213. Scheen, André J. Hepatotoxicity with Thiazolidinediones: Is it aClass Effect? Drug Safety: 2001: 24(12) :873-8814. Type 2 diabetes mellitus- An evidence based approach topractical management by Mark N Feinglos and M AngelynB e t h e l , 2 0 0 8 , H u m a n a p r e s s . Av a i l a b l e f r o mhttp://books.google.ae/booksIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 35

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaComparison of days lost due to disability and Karnofsky performance status in burden ofdiclofenac induced adverse drug reactions1 2 3Thomas D* , Mathew M and Mahendra Kumar B.J1Head, Dept of Pharmacy Practice, RIPER, A.P., India2Principal, Malik Deenar College of Pharmacy, Kasaragod, Kerala, India3Prof & Head, Dept of Pharmacy Practice, Director PG Studies, JDT Islam College of Pharmacy, Kozhikode, Kerala, IndiaA B S T R A C TSubmitted: 24/08/2012Accepted: 12/09/2012Basic objective of this study was to find out the benefit of Days Lost due to Disability (DLD) over Karnofsky Performance Status (KPS) in detectingthe burden of Adverse Drug Reactions (ADRs) of diclofenac tablet in clinically recovered male and female groups. This was a cohort study done in1000 prescriptions of diclofenac tablets to find out the burden of its ADRs in a popular pharmacy in Kasaragod District, Kerala, India. Stratifiedrandomized sampling was done to male and female strata to compare DLD and QoL using KPS. DLD considers incidence and duration of ADRs inaddition to the QoL component, disability weight to give a more complete burden of disease score. For cutaneous reaction, female scored 61 DLDover 26 in male. For peptic ulcer female scored 40 over 37 in male, even though males had higher incidence. Female suffered from higher DLD inother ADRs too. DLD was found to be more complete and sensitive tool than KPS QoL tool in calculating the burden of ADRs due to diclofenactablet. Female gender is a contributing factor of increased burden of ADRs.Keywords: peptic ulcer, diclofenac, ADR, femaleINTRODUCTIONBurden of disease or illness could be effectively calculated bydisability adjusted life years (DALY) or quality of life (QoL)tools. DALY has two components i.e., years of life lost (YLL)and years lost due to disability (YLD). YLD assess burden ofdisease or illness in survived casualties. While studyingburden of illness in clinically recovered cases of adverse drugreactions (ADRs), most of the times the suffering of ADRslasts few days. So rather than calculating it for years, as it is inYLD, it could be calculated in days, thus becoming days lostdue to disability (DLD). In this study we plan to assess thesensitivity of DLD by comparing with Karnofskyperformance status (KPS) in gender variation in the burden ofADRs caused by diclofenac tablet.Burden of ADRs were commonly assessed by the decrease inquality of life. Days Lost due to Disability (DLD) which ispart disability adjusted life years is a more advanced tool tocalculate burden of ADRs than Karnofsky PerformanceStatus. DLD is a new tool introduced by the authors. It couldbe calculated for 100 or 1000 population. The key limitation isthat it could be calculated only for clinically recovered ADRs.Address for Correspondence:Dixon Thomas, Associate Professor & Head, Dept of Pharmacy Practice,Raghavendra Institute of Pharmaceutical, Education and Research (RIPER)Chiyyedu Post, Anantapur 515721, AP, IndiaE-mail: dixon.thomas@gmail.comQoL or performance status is one of the commonly usedclinical outcome research tools in many of the illness. Thereare general QoL tools and disease specific tools. Compromisein QoL is used to measure the influence of disease on healthwhen a medical (mainly pharmaceutical) and/or surgicalintervention is used, improvement in QoL could be measuredto study the influence of treatment of disease. At the sametime the medicines also could cause ADR and compromisefurther on QoL. Practically it becomes very difficult toseparate the compromise on health happened due to disease1and ADR on an observational study.DLD is a more complete tool to assess burden of disease orADRs by calculating the incidence, duration and disabilityweight (DW). DLD have a component of QoL in the form of2DW. DW could be measured in a scale between 0 to 1, where30 becomes perfect health and 1 becomes the worst. KPS is awidely used QoL or performance status tool for many decadesin different disease settings. KPS is a very structuredquestionnaire scoring 0 to 100, were 0 becomes death and 1004becomes perfect health. KPS results could be easilyconverted to the scale of 0 to 1 and then 1 - KPS gives DW.DW also could be measured in an analogue scale.While measuring QoL, we had experienced that subjectivemeasures dominate over objective measures. Perception ofthe patients on their health is an important factor of their QoL.Generally females consider ill health more importantly thanmales. They shall be more cautious in prevention andIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 36

Thomas D - Comparison of days lost due to disability and Karnofsky performance status in burden of diclofenac induced adverse drug reactionsmanagement of ADRs. This could be one of the reasons whenan ADR happens, it shall subjectively affect the quality of life4to a higher extent in female.In addition to the QoL component i.e., DW, DLD measuresthe incidence rate and duration of illness/ADR in the cohort.Thus, the usefulness of DLD over QoL in assessing theburden of ADRs could be measured with an example of3gender influence in ADRs of diclofenac tablet. If DLD isfound to be more sensitive in than QoL, it could be furtherstudied in future in comparison with other QoL tools,epidemiologically different study groups and different ADRsof different medicines. The findings will have anticipatedgeneralizability to use DLD in more clinical settings. AndNSAIDs including diclofenac is one of the top groups of5-6medicines to cause ADRs. DLD is a new tool which was notused previously to measure the burden of ADRs in clinicallyrecovered patients. DALY was commonly used by WorldHealth Organization in calculating the burden of diseases orillness. DLD evolved with minor changes in one of thecomponent of DALY. And it is a new discovery of a valuabletool in pharmacovigilance and drug safety to quantify theburden of ADRs which was difficult to be studied by theotherwise commonly used QoL tools.METHODSThe study was done in a popular pharmacy in KasaragodDistrict, Kerala, India. Stratified random sampling was usedto male and female groups who consume diclofenac tablets.Equal number of males & females (500 each) were enrolled inthe study strata (groups) based on a total of 1000 prescriptionsof diclofenac. ADRs were reported based on the diagnosis ofthe doctor, Naranjo Algorithm for causality assessment andfinally filling out the ADR reporting form by Central DrugsStandards Control Organization, India. Our study focused onthe influence of gender on ADRs, not on the ailments requiredto be treated with NSAIMs. The differences obtained in eachADRs in QoL and DLD was compared numerically in maleand female groups. Ethical committee approval was takenand confidentiality of the subjects maintained.Calculation of DLDDLD = I x DW x LI is the number of incidences of disease or injury (ADR)DW is the disability weight and L is the average duration ofdisease or injury in days up to clinical recovery or death. (In2case of YLD it is years instead of days).Inclusion criteriaPatients taking diclofenac tablets were selected to the maleand female groups.Patients in the age range of 18 to 64 were included in thestudy.Patients with possible, probable, or definite causalities withADRs of diclofenac were selected for calculation of DLD.Exclusion criteriaThose who were prescribed with different NSAIMs,corticosteroids or other potential ulcerogenic medications inthe past one month were excluded.Those who smoke on an average 10 or more cigarettes per dayor consume on an average 2 or more alcoholic drinks per daywere excluded.Unrecovered, and irreversible organ failure patients fromtheir ADRs were excluded.Rare ADRs are excluded as they were not enough in numberto compare between groups.Geriatric, pediatric, pregnant and breastfeeding populationwere excluded.Patients who were unwilling or unable to understand thestudy questions and/or those who are not in a position(mentally or socially compromised) to provided competentanswers were excluded.RESULTS & DISCUSSIONIt was found in many studies that females have moreincidences of ADRs compared to males. But diclofenacinduced peptic ulcer disease (PUD) was an exemption.Incidence of diclofenac induced PUD was slightly higher inmales than females. But the difference was not statisticallysignificant (p >0.05). (Table 1)Many of the literature suggest that PUD is higher in malesthan females. The major reason could be smoking. Just beingmale was not found to be a significant factor in the studypopulation who develop diclofenac induced PUD. Femalegender could be a contributing factor of increased burden ofADRs (p

Thomas D - Comparison of days lost due to disability and Karnofsky performance status in burden of diclofenac induced adverse drug reactionsTable 1: DLDs in diclofenac tablet induced ADRs in males and femalesI L DW DLD I L DW DLD(Incidence) (Disability (Duration) (IxLxDW)Weight)Rash, urticaria, dermatitis 32 3.9 0.21 26 46 5.3 0.25 61Peptic ulcer 18 6.9 0.3 37 16 7.8 0.32 40Dizziness, drowsiness,depression, insomnia, anxiety 19 2.6 0.07 04 32 3.8 0.12 15Oliguria, protienuria 16 3.9 0.06 04 21 4.2 0.06 05Edema, hypertension 15 4.6 0.1 20 822 5.4 0.17 20I is the number of incidences of disease or injury (ADR), DW is the disability weight andL is the average duration of disease or injury in days up to clinical recovery or death.Table 2: KPS QoLs in diclofenac tablet induced ADRs inmales and femalesADRs QoLMales FemalesRash,urticaria, dermatitis 79 75Peptic ulcer 70 68Dizziness, drowsiness,depression, insomnia, anxiety 93 88Oliguria, protienuria 94 94Edema, hypertension 88 83DLD due to longer duration and higher DW with the ADR.This example further shows the advantage of DLD over QoL.Incidence and burden of ADRs are generally high in femalesas per most of the literature. Our study findings are consistentwith the knowledge that women suffer more with ADRs.Diclofenac induced peptic ulcer disease was an exception, asthe incidence was higher in males (not statisticallysignificant) but burden of it on health was higher in femalesdue to longer duration and higher disability weight.Limitations of the study include that, the pharmacy was busymost of the times and there were limited private counselingfacilities/opportunities to discus with patients in fullconfidence. Also we doubt the completeness of the studypopulation to represent the people of the community, as manyof the patients who consume diclofenac tablets were notphysically available or not cooperating; we couldn't alsoclaim to cover all patients presented to pharmacy werescreened for the study. So the incidence of ADRs reported inthe study lacks precision and the skills of pharmacists inidentifying ADRs could be used efficiently preferably withthe help of a doctor, in community pharmacy there is lessscope for making a consensus decision. These factors shalldecrease the number of ADRs reported. But this studystrongly points out the advantage of DLD over KPS QoL(which is one of the most convenient one) in measuring theburden of ADRs of diclofenac.CONCLUSIONAs a matter of fact, female suffer from ADRs more than male.This statement was supported by our findings on increasedDLD on ADRs of diclofenac in female. While considering theQoL, the KPS tool was not as sensitive as DLD in finding thegender variation in the burden of ADRs. There could be otherQoL tools which are more specific and more sensitive. But itis interesting to notice that DLD is an advanced tool whichadditionally considers the incidence and duration with theQoL component (DW). So DLD gives a more completemeasure of burden of ADRs due to diclofenac tablet. Inevaluating the burden of clinically recovered ADRs it is morecomplete and sensitive tool for the purpose.REFERENCES1. Barofsky Ivan. Can quality or quality-of-life be defined? Quallife res 2012; 21(4):625-31.2. Thomas D, Mathew M, Raghavan VC, Mohanta GP, Reddy PY.Days lost due to disability of diclofenac-induced adverse drugreactions. Pharmacy Practice (Internet) 2012; 10(1):40-44,available at: http://www.pharmacypractice.org/vol10/pdf/040-044.pdf (Accessed on May, 28, 2012).3. WHO, GBD study Operations Manuel, Jan 2009, available at:http://www.globalburden.org/GBD_Study_Operations_Manual_Jan_20_2009.pdf (Accessed on June, 1, 2012).4. Kimmel Paul L. Just whose quality of life is it anyway?Controversies and consistencies in measurements of quality oflife, Kidney Int 2000; 57, S113–S120; available at:Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 38

Thomas D - Comparison of days lost due to disability and Karnofsky performance status in burden of diclofenac induced adverse drug reactionshttp://www.nature.com/ki/journal/v57/n74s/full/4491632a.html(Accessed on June, 1, 2012).5. Wilkerson L and Blacketer TM. Reducing the burden of adversedrug events. The Kentucky Pharmacist May 2012; 34-38.6. Chawla S, Kalra BS, Dharmshaktu P and Sahni P. Adversedrug reaction monitoring in a tertiary care teaching hospital. JPharmacol Pharmacother 2011; 2(3):196-198.7. Elghuel Abdulbaset. The characteristics of adults with uppergastrointestinal bleeding admitted to Tripoli Medical Center: aretrospective case-series analysis. Libyan J Med 2011, 6:6283, available at: www.ajol.info/index.php/ljm/article/download/ 70650/59248 (Accessed on May, 28, 2012).Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 39

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaThe Prevalence of Polypharmacy in South Indian Patients:A Pharmacoepidemiological Approach.Mohammed S.S*, Sreenath.M.K, Vishnu V.G, Jose F, Siraj S.T, Anand V.P.R.*Pharmacy Coordinator & Adjunct Faculty, School of Pharmacy, Gulf Medical University, Ajman, UAE.Department of Pharmacy Practice, JSS College of Pharmacy, JSS University, Rocklands, Ooty, Nilgiris, India – 643001A B S T R A C TSubmitted: 26/06/2012Accepted: 12/09/2012The study conducted assessed the prevalence of polypharmacy and identified the individuals particularly at risk of polypharmacy.Data collectionwas based on the prescriptions collected from patient's hospital records and case sheets. The collected prescriptions were scrutinized forpolypharmacy and were categorized as minor polypharmacy - concurrent use of 2 to 4 drugs; and major polypharmacy – concurrent use of five ormore drugs. Out of 1003 prescriptions 630 prescriptions were found to be minor polypharmacy and 373 prescriptions were majorpolypharmacy.The results showed that major polypharmacy was more prevalent among the cardiovascular diseases (31.5%) followed by the infectiousdiseases (23.67%) and was seen to be least in dermatological diseases (0.67 %); the minor polypharmacy was prevalent in gastrointestinaldisorders (24.07 %) followed by the infectious diseases (20.10 %) and least in dermatological diseases (1.74 %).Based on the informationobtained from our study suggestions to reduce the polypharmacy related problemsare as follows: Ask patients to bring all medicines to counselingcenter ; Control pro re nata prescribing; Select a drug that have more than one indication; Start with low doses and titrate dose according to effect;Monitor for adverse reactions and check for potential drug interactions; Routinely check and encourage compliance; Periodically simplify thetherapeutic regimen and stop drugs if possible; Educate the patient about the drug therapy and teach the patient to prioritize the currently useddrugs; Place limits on the duration of drug prescribing.Keywords: Polypharmacy, Drug therapy, Drug utilization, Prescribing pattern.INTRODUCTIONPolypharmacy is the use of several drugs or medicinestogether in the treatment of disease, suggestingindiscriminate, unscientific, or excessive prescription.Polypharmacy is defined as a condition in which a patientreceives too many drugs for too long time, or drug in1exceedingly high doses often result. The unavoidableconsequence is that increasingly frail patients are being2treated with Polypharmacy. Chesteret al have mentioned thatthere is no consistent definition for polypharmacy in theliterature and that many authors define it simply as the use of3five or six medications. However polypharmacy is muchmore complex than just the number of medication a patient4,5uses. Polypharmacy may be appropriate if all drugs in theregimen address recognized indications or inappropriate ifmore drugs prescribed than necessary, drugs withunacceptable side effects or toxicity prescribed, either whenused alone or in combination with other medications in theregimen, or redundant drugs prescribed.Address for Correspondence:Dr. Mohammed Saji S, Pharmacy Coordinator & Adjunct Faculty, School ofPharmacy, Gulf Medical University, Ajman, UAE.E-mail: drmohdsaji@gmail.comPolypharmacy in a managed care setting presents a unique set6of challenges and opportunities. Intervention to reducepolypharmacy must address several issues such asappropriate medication usage in elderly, including theappropriateness indication, drug-drug duplication in the sameclass of therapeutics, inappropriate and complex dosing,drug-drug interaction, drug disease interaction, drug foodinteraction, coordination of the medication between primarycare provider and specialists, use of drug holidays, andeducation of member regarding adverse drug effects and other7issues related to compliance.There are many potential risks associated with polypharmacy.When several medications are used simultaneously, there isan increased risk of drug-drug interactions and adverse drug8reactions. Epidemiological studies of risk factors for adversedrug reactions have shown that the number of concurrentlyused drugs is the most important predictor of these9complications.Polypharmacy increases the risk of hospitalizations, and10,11medication errors. These factors eventually lead toincreased patient costs, non-adherence to treatment,12, 13increased rate of patient morbidity and mortality.Studies from many countries have shown that aIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 40

Mohammed S.S - The Prevalence of Polypharmacy in South Indian Patients: A Pharmacoepidemiological Approach.considerablepart of hospital admissions is precipitated by14drug-related problems and iatrogenic illness. Polypharmacymay be responsible for unnecessary health expendituresdirectly due to the cost of superfluous medication, but alsoindirectly due to the increased number of hospitalizations15caused by drug-related complications. The beneficial effectof reducing the occurrence of polypharmacy in the populationhas been addressed in order to cut down on expenditures forboth physician and hospital services. A study examining thefactors associated with variations in general practitionerprescribing costs showed that diagnoses associated withmultiple drug use (cardiovascular diseases, diabetes mellitus,psychiatric disorders) were strongly related to high drugexpenditures. The occurrence of multi-morbidity predictedhigh prescribing costs. A considerable part of the health careresources is thus used for costs due to expensive multiple drugregimens and expenditures caused by drug-related morbidity16attributable to polypharmacy.The present study was aimed to identify the prevalence andthe associated risk factors of polypharmacy in our hospitalsettings.The main purpose of this study was to develop aprescription database and to compare different methods ofidentifying drug users exposed to polypharmacy.MATERIALS AND METHODSThe study was conductedinGovernment District HeadQuarters Hospital, Ooty for a period of one year (August 2009to April 2010). The study involved collection of data bothprospectively and retrospectively. All prescriptions whichcontain more than one drug and of age between 2-70 yearswere included in the study. Patients with age less than 2 yearsand with conditions like psychiatric & cancer disorders wereexcluded from the study. Polypharmacy was classifiedaccording to British National Formulary (BNF)i.e. theconcurrent use of 2 to 4 drugs are classified as minorpolypharmacy and of five or more drugs as majorpolypharmacy.The study protocol was approved by the Institutional ReviewBoard of JSS College of Pharmacy, Ooty, India. Theprescriptions were collected from patient's hospital recordsand patient counseling center after getting consent from thepatients.The collected prescriptions were entered intoMicrosoft Office Excel sheet according to their age, gender,therapeutic category; number of prescription, length ofhospital stay etc. and a prescription database was generated.All collected prescription details were scrutinized and wereclassified as major or minor polypharmacy.RESULTSA total of 1003 prescriptions were collected from theGovernment District Head Quarters Hospital. Out of 1003prescriptions 600 prescriptions found with majorpolypharmacy and 403 prescriptions with minorpolypharmacy.In our total study population 670 (66.80%) cases were malesand 333 (33.20%) were females.The total populations wereclassified into three major age groups and patient in eachgroup were recorded. The data from our study represent that;up to 18 years 4.39% (N=44), 19-60 years 83.75% (N=840)and above 60 years 11.86% (N=119). Graphicalrepresentation of age distribution in the study population isgiven in Figure1.Fig. 1: Age Vs Total number of prescriptionQuantitative Estimation of PolypharmacyOut of 1003 prescriptions 403 (40.18%) prescriptions werefound to be of minor polypharmacy and 600 (59.82%)prescriptions were of major polypharmacy.a) Polypharmacy Vs Gender: In minor Polypharmacy(N=403), 227 were males and 176 were females. Out of 600major Polypharmacy, 443 were males and 157 werefemales.Table 1 explains the prevalence of Polypharmacy inboth genders in the study population.Table 1: Polypharmacy Vs GenderNumber of drugs Male Female Total Percentage2-4 227 176 403 40.18%≥5 443 157 600 59.82%b) Polypharmacy Vs Age: The numbers of drugs prescribedto the various age groups were analyzed and are presented inTable 2.Table 2: Polypharmacy Vs AgeNumber of drug Age Group Number of Percentageprescribedprescription2-4 ≤18 24 5.96%19-60 316 78.41%≥6 163 15.63%≥5 ≤18 20 3.33%19-60 524 87.33%≥61 56 9.33%Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 41

Mohammed S.S - The Prevalence of Polypharmacy in South Indian Patients: A Pharmacoepidemiological Approach.c) Polypharmacy Vs Hospital stays: The association ofpolypharmacy and hospital stay was analyzed and the resultsare given in Table 3. In both minor and major polypharmacyhospital stay less than one week found. In majorpolypharmacy about 45.50% had one to two weeks of hospitalstay.Quantitative Estimation of Therapeutic Categories ofPrescriptions: The collected prescriptions were classifiedaccording to the British National Formulary and the numberof prescriptions in each category is given in Table 4. Out of thetotal prescriptions cardiovascular, infections andgastrointestinal system accounted for major cases.Thepercentage of therapeutic categories of all prescribed drugs inthe study population is graphically represented in Figure 2.d) Therapeutic class Vs Polypharmacy: The assessment ofpolypharmacy in each therapeutic class was carried out andthe prevalence of polypharmacy was estimated. The resultsare presented in Table 5. The results shows that majorpolypharmacy is more prevalent in cardiovascular systemdiseases (31.5%) followed by infectious diseases (23.67%).e) Therapeutic class Vs Age group: The patient prescribedwith cardiovascular drugs and gastrointestinal drugs weremore often involved in the polypharmacy among the elderlypopulation, while infectious and cardiovascular drugs wereprominent among young individuals exposed topolypharmacy. The table 6 represents the conception oftherapeutic class of drug by different age group.f) Therapeutic class Vs Hospital stays: The duration oftreatment varies with severity of disease. Our result shows theheterogeneous data with respect to duration of therapy andFig. 2: Percentage of therapeutic categories of allprescribed drugs.Table 4: Quantitative Estimation of Therapeutic Categoriesof PrescriptionsTherapeutic class Number of prescription PercentagecollectedCardiovascular System 267 26.62%Infections 223 22.23%Gastrointestinal System 178 17.75%Respiratory System 144 14.36%Central Nervous System 120 11.96%Endocrine System 23 2.29%Musculoskeletal System 21 2.09%Dermatology 11 1.10%Obstetrics and Gynecology 16 1.60%Table 3: Polypharmacy Vs Hospital stayNumber of drugs 1 week 1-2 week >2 week Total Percentage oftotal prescription2-4 258 (64.02%) 117(29.03%) 28(6.95%) 403 40.18%≥5 296 (49.33%) 273(45.50%) 31(5.17%) 600 59.82%Table 5: Therapeutic class Vs PolypharmacyTherapeutic class Minor Polypharmacy Percentage Major Polypharmacy Percentage(2-4 drugs) (%) (≥5) (%)Cardiovascular System 78 19.35 189 31.50Infections 81 20.10 142 23.67Gastrointestinal System 97 24.07 81 13.50Respiratory System 73 18.11 71 11.83Central Nervous System 44 10.92 76 12.67Endocrine System 11 2.73 12 2.00Musculoskeletal System 12 2.98 9 1.50Dermatology 7 1.74 4 0.67Obstetrics and Gynecology Nil Nil 16 2.67Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 42

Mohammed S.S - The Prevalence of Polypharmacy in South Indian Patients: A Pharmacoepidemiological Approach.therapeutic category of drugs. Prevalence of short termtherapy was high with gastrointestinal and infectious diseaseswhereas long term therapy was prominent withcardiovascular and respiratory diseases. TheTable 7.1 and 7.2represents the length of hospital stays for different therapeuticcategory.DISCUSSIONPolypharmacy was a frequent condition in Indian populationespecially among elderly population. Polypharmacy mainlydepends on the type of the disease and co-morbidconditions.The majority of drug users exposed topolypharmacy exhibited a very heterogeneous pattern of drugcombination and mostly individual subject to majorpolypharmacy had their own unique drug combination, differfrom all other drug users.Table 6: Therapeutic class Vs Age groupVariableAgeTherapeutic class ≤18 19-60 ≥61(n=44) (n=840) (n=119)Cardiovascular System Nil 235(27.98%) 32(26.89%)Infections 16(36.36%) 195(23.21%) 12(10.08%)Gastrointestinal System 11(25.00%) 143(17.02%) 24(20.17%)Respiratory System 2(4.55%) 126(15.00%) 16(13.45%)Central Nervous System 8(18.18%) 89(10.60%) 23(19.33%)Endocrine System Nil 17(2.02%) 6(5.04%)Musculoskeletal System 2(4.55%) 16(1.90%) 3(2.52%)Dermatology 5(11.36%) 3(0.36%) 3(2.52%)Obstetrics and Gynecology Nil 16(1.90%) NilTable 7.1: Therapeutic class Vs Hospital stays(Minor Polypharmacy)VariableLength of hospital stay forMinor PolypharmacyTherapeutic category ≤1 week 1-2 week ≥2 week(n=258) (n=117) (n=28)Cardiovascular System 52(20.63%) 23(19.66%) 3(10.71%)Infections 58(23.02%) 17(14.53%) 6(21.43%)Gastrointestinal System 70(27.78%) 17(14.53%) 10(35.71%)Respiratory System 32(12.70%) 38(32.48%) 3(10.71%)Central Nervous System 18(7.14%) 22(18.80%) 4(14.29%)Endocrine System 9(3.57%) Nil 2(7.14%)Musculoskeletal System 12(4.76%) Nil NilDermatology 7(2.78%) Nil NilObstetrics and Gynecology Nil Nil NilTable 7.1: Therapeutic class Vs Hospital stays(Major Polypharmacy)VariableLength of hospital stay forMajor PolypharmacyTherapeutic category ≤1 week 1-2 week ≥2 weekIn this study we used hospital case sheets of patients for theestimation of incidence and prevalence of polypharmacy.Inour study prescriptions were classified into minorpolypharmacy (2 to 4 Drugs) and major Polypharmacy (>5Drugs). Polypharmacy is more prevalent in the age group 19to 60 years. Reason may be increase in the prevalence ofdisease and change in physiology or increase in the number ofelderly population.In the most of the studies of polypharmacyfemale sex and old age have been predictors of polypharmacy,but few studies have not found this correlation. Our resultsshow that there is a higher prevalence of polypharmacyamong the men than women.In our study we found that thelength of hospital stay has shown an increase in majorpolypharmacy compare to minor polypharmacy.Because ofage related changes in pharmacokinetics (i.e., absorption,distribution, metabolism, and excretion) andpharmacodynamics (the pharmacologic effects of a drug),many drugs must be used with particular caution elderlypatients. Our data suggests that prevalence of cardiovasculardrugs and gastrointestinal drugs were more often involved inthe polypharmacy among the elderly population, whileinfectious and cardiovascular drugs were prominent amongyoung individuals exposed to polypharmacy.Based on the knowledge obtained from our study, suggestionsto reduce the problems associated with polypharmacy are asfollows:Ÿ Ask patients to bring all medicines to the counselingcenter (the brown bag approach)Ÿ Restrict pro re nata prescribing(n=296) (n=273) (n=31)Cardiovascular System 89(30.07%) 96(35.16%) 4(12.90%)Infections 76(25.68%) 60(21.98%) 6(19.35%)Gastrointestinal System 39(13.18%) 40(14.65%) 2(6.45%)Respiratory System 26(8.78%) 39(14.29%) 6(19.35%)Central Nervous System 36(12.16%) 29(10.62%) 11(35.48%)Endocrine System 9(3.04%) 1(0.37%) 2(6.45%)Musculoskeletal System 9(3.04%) Nil NilDermatology 4(1.35%) Nil NilObstetrics and Gynecology 8(2.70%) 8(2.93%) NilŸ Encourage physicians to prescribe using evidence-basedmedicineŸ Select a drug that may treat more than one conditionIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 43

Mohammed S.S - The Prevalence of Polypharmacy in South Indian Patients: A Pharmacoepidemiological Approach.Ÿ Check for contraindications and potential druginteractions before prescribing a drugŸ Start with low doses and titrate dose according to effectŸ Monitor for adverse reactions and check potential druginteractionsŸ Educate the patient about the drug therapy and teach thepatient to prioritize the currently used drugsŸ Routinely check and encourage complianceŸ Periodically simplify the therapeutic regimen and stopdrugs if possibleŸ Place limits on the duration of drug prescribingCONCLUSIONThe use of medication to disease condition is necessary, butunnecessary load of drugs to patient will increase the safetyproblems. Polypharmacy can be avoided by sharing thedecisions for making treatment goals and plans. Themedication regimen can be simplified by eliminatingpharmacological duplication, decreasing dosing frequencyand regular review of drug regimen. The goal should be toprescribe the least complex drug regimen for the patient aspossible while considering the medication problems,symptoms and off course the cost of therapy.CONFLICT OF INTERESTThe authors declare that they have no conflict of interest.ACKNOWLEDGMENTSThe authors wish to thank all the faculty members of variousdepartments of Government District Hospital, JSS MedicalCollege and the Medical Record Department (MRD) staffs,for their support and kind cooperation in issuing the medicalreports. We also extend our sincere gratitude to all the facultyof Department of Pharmacy Practice, JSS College ofPharmacy, Ooty and JSS College of Pharmacy, Mysore fortheir valuable guidance. We extend our heartfelt thankfulnessto the Principal JSS College of Pharmacy, Ooty and Vice-Chancellor, JSS University, Mysore for their timely support tocomplete this work.REFERENCES1. Steinman M.A, Landefeld CS, Rosenthal GE, Berthenthal D,Sen S, Kaboli PJ. Polypharmacy and prescribing quality in olderpeople. J Am Geriatr Soc. 2006 Oct;54(10):1516-23.2. Hajjar ER, Hanlon JT, Sloane RJ, Lindblad CI, Pieper CF, RubyCM, Branch LC, Schmader KE. Unnecessary drug use in frailolder people at hospital discharge. J Am Geriatr Soc. 2005Sep;53(9):1518-23.3. Chester BG. Polypharmacy in Elderly Patients With Diabetes.Diabetes Spec. 2002 Oct; 15(4):240-48.4. Muir AJ, Sanders LL, Wilkinson WE, Schmader K. Reducingmedication regimen complexity: a controlled trial. J Gen InternMed. 2001 Feb;16(2):77-82.5. Fulmer T, Kim ST, Montgomery K, Lyder C. What the LiteratureTells Us About The Complexity of Medication Compliance in theElderlyGenerations. 2000 Feb;24(4):43-48.6. Montamat SC, Cusack B. Overcoming problems withpolypharmacy and drug misuse in the elderly. ClinGeriatr Med.1992 Feb;8(1):143-58.7. Rollason V, Vogt N. Reduction of polypharmacy in the elderly: asystematic review of the role of the pharmacist. Drugs Aging.2003;20(11):817-32.8. Kurfees JF, Dotson RL. Drug interactions in the elderly. JFamPract. 1987 Nov;25(5):477-88.9. Flaherty JH, Perry HM 3rd, Lynchard GS, Morley JE.Polypharmacy and hospitalization among older home carepatients. J Gerontol A BiolSci Med Sci. 2000 Oct;55(10):554-9.10. Winterstein AG, Sauer BC, Hepler CD, Poole C. Preventabledrug-related hospital admissions. Ann Pharmacother. 2002 Jul-Aug;36(7-8):1238-48.11. Michocki RJ, Lamy PP, Hooper FJ, Richardson JP. Drugprescribing for the elderly. Arch Fam Med. 1993 Apr;2(4):441-4.12. Incalzi RA, Gemma A, Capparella O, Terranova L, Porcedda P,Tresalti E, Carbonin P. Predicting mortality and length of stay ofgeriatric patients in an acute care general hospital. J Gerontol.1992 Mar;47(2):M35-9.13. Linjakumpu T, Hartikainen S, Klaukka T, Veijola J, Kivelä SL,IsoahoR.Use of medications and polypharmacy are increasingamong the elderly. . J ClinEpidemiol. 2002 Aug;55(8):809-17.14. Reus VIRational polypharmacy in the treatment of mooddisorders. Ann Clin Psychiatry. 1993 Jun;5(2):91-100.15. Nolan PE Jr, Marcus FI. Cardiovascular Drug Use in the Elderly.Am J GeriatrCardiol. 2000 May;9(3):127-129.16. Bjerrum L, Sogaard J, Hallas J, Kragstrup J. Polypharmacy:correlations with sex, age and drug regimen. A prescriptiondatabase study. Eur J ClinPharmacol. 1998 May;54(3):197-202.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 44

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaAssociated socioeconomic status with illness behavior in tuberculosis patientsundergoing DOTS therapy1 3 3 1 1 1Munsab A* , Manju S , Abul Kalam Najmi , Faisal I , Santanu M , Ravinder K M1Assistant Professor, Department of Pharmacy, Translam Institute of Pharmaceutical Education & Research, Rajpura, Meerut, Uttar Pradesh,India2Associate Professor, Department of Epidemiology & Public Health, Lala Ram Sarup Institute of Tuberculosis & Respiratory Disease, SriAurobindo Marg, New Delhi, India3Associate Professor, Department of Pharmacology, Faculty of Pharmacy, Jamia Hamdard, New Delhi, IndiaA B S T R A C TSubmitted: 22/06/2012Accepted: 29/06/2012The aim of the present study was to investigate whether socioeconomic status can influence the illness behaviour of tuberculosis patient. Thepresent study was a prospective for which we compared tuberculosis patients (case, group-I) with other respiratory disease patients (control,group II) on the basis of illness behaviour questionnaire (IBQ) and observed for possible differences between the two patient subgroups. Numberof patients enrolled for the study were 82 out of whom, 41 patients served as case (i.e. group-I) and 41 patients as control (i.e. group-II). Group-Ireceived standard Directly Observed treatment Shortcourse (DOTS) therapy as per Revised National TB Control Program (RNTCP) guidelinesand was categorized as illness behavior under DOTS therapy. The group-II diagnosed patients of chronic respiratory disease like ChronicObstructive Pulmonary Disease (COPD), Asthma, Chronic bronchitis etc. by the respective physicians. The data were fed into the computerprogramme SPSS and odd Ratios (OR) along with Confidence intervals (CI) and p-value were calculated for all the items to find out differencebetween cases and controls, if any. The present study reveals that socioeconomic status in tuberculosis patients tends to develop more intenseillness behaviour as compared to other respiratory disease patient. Tuberculosis not only affects the body but it also affects the behavior of thepatients. Therefore, management of illness behaviour should also be included in management of tuberculous patients.Keywords: Tuberculosis, DOTS, RNTCP, respiratory disordersINTRODUCTION1Globally, tuberculosis is a major issue in public health. Onethirdof the world's burden of tuberculosis (TB), or about 4.9million prevalent cases, were found in the World Health2Organization (WHO) in South-East Asia Region.Tuberculosis continues to remain one of the most pressinghealth problems in India. India is the highest TB burdencountry in the world, accounting for one fifth of the globalincidence- an estimated 1.96 million cases annually.Approximately 2.9 million die from TB each year worldwide;about one fifth of them in India alone. India has 2% of the landarea of the world and 15% of its total population. About500,000 died from the disease and more than 1000 per day –one in every minute. Nearly 40% of the Indian population is3.4.5infected with the TB bacillus.Address for Correspondence:Mr. Munsab Ali, Assistant Professor, Department of Pharmacology, TranslamInstitute of Pharmaceutical Education & Research, Meerut Uttar Pardesh-250001, IndiaE-mail: munsab2008@gmail.comTB is major barrier to economic development because it ismore prevalent in highly economic productive age group 20 to50 year, therefore affecting the economic development of thecountry thus TB costing India 13000 crores a year. On anaverage a TB patient loose 3-4 months of wage equivalent to20 to 30% of annual house hold income, thereby making thepoor poorer. TB has devastating social cost as data suggestedthat each year; more than 300,000 children are forced to leave6school on account of TB.Illness behaviour refers to the activities undertaken byindividuals in response to symptom experience. It typicallyincludes mental debate about the significance and seriousnessof these symptoms, lay consultation, decision about actionincluding self-medication, and constant with health7professionals. Perception of illness has been found to varywith cultural, ethnicity, education, family structure and8socioeconomic difference. Treatment of active TB requiresprolonged therapy (at least 6 months) with multiple,potentially toxic drugs that can lead to adverse reactions in a9significant number of patients. Also, among foreign bornpatients, if considerable social stigma associated with activeTB leaving the individual feeling shunned and isolated fromIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 45

Munsab Ali - Associated socioeconomic status with illness behavior in tuberculosis patients undergoing DOTS therapy10their friends and families. Among aboriginal andmarginalized inner city populations, there is a lack ofknowledge regarding the disease process and its treatment11which may contribute to feelings of helplessness and anxietyand education also play an important role in changing thepatients health behaviour by providing them with information12that motivates them to follow the treatment plan.Awareness about depression and its role in the outcome ofchronic disorders like rheumatoid arthritis and COPD has13increased over the years. Depression is common in patients14with TB, affecting up to 52% patients. The patients sufferingfrom tuberculosis shows a higher degree of neuroticism. Thiscould be because of the nature of illness, prolonged treatment,stigma, misconceptions about illness, reactions of familymembers, and economical stress (either because ofmedication, follow-up or decrease in productivity). Thesepatients develop psychosocial reactions such as denial,hopelessness about life, fear of neglect by the spouse, familyand society. Tuberculosis, like any other chronic infection,needs treatment for a prolonged period. It carries social stigma15,16and result in adverse psychological reactions. A studyshowed that depression is more prevalent among elderlypersons and in female, labor class patients, illiterates,17separated or widowed and those with low per capita income.Low socioeconomic status (SES) is generally associated withhigh psychiatric morbidity, more disability, and poor access tohealth care. Among psychiatric disorders, depression exhibits18a more controversial association with SES. Socio-economicstatus, whether measured by education, income or otherindices of social class, has long been known to be associated19with attitudes and health care practice. The impact ofsocioeconomic status on symptoms, respiratory morbidityand mortality is important because it may influence behavior20towards health seeking. The low-income population alsosuffer from overcrowding and malnutrition, and therefore is21predisposed to developing TB.STUDY DESIGN AND METHODOLOGYThe present study was a prospective study to find out “theassociation of socioeconomic status with illness behaviour intuberculosis patients, undergoing DOT Therapy” at DOTScentre of defined Lala Ram Sarup-Revised National TBControl Program (LRS-RNTCP) area. The study wasperformed on patients receiving combination anti-tuberculartherapy for the management of tuberculosis registered underRNTCP for DOTS regimen. The category I patients of LRS-RNTCP defined area were enrolled in the study. All patientsreceiving or registered under category I were interviewedduring intensive phase as a case (group I) and equal numberof control patients (group II) were taken from samedispensary OPD where the DOTS centre is situated. Thecontrol group was diagnosed patients of chronic respiratorydiseases like COPD, Asthma, Chronic bronchitis,Emphysema, Cystic fibrosis, Sinusitis, Lung cancer andObstructive sleep apnoea by their physicians in respectivedispensaries. The patients attending OPD with record of prediagnosedchronic respiratory diseases by allopathic doctorwere also included in the control group. The socioeconomicstatus with illness behavior was checked on the basis ofinterview to patient directly. All the observation was recordedin a simple pre-designed and pre-tested semi structuredstandard monitoring formats.A total of 350 patients were enrolled in LRS-RNTCP definedarea for treatment, out of which 82 were enrolled in this study.41 patients served as case (i.e. group I) and 41 patients ascontrol (i.e. group II). The group I received standard DOTStherapy as per RNTCP guidelines and was categorized asillness behavior under DOTS therapy. The group II wasdiagnosed patients of chronic respiratory diseases.The present study was initiated after prior approval of theprotocol by the Research and Ethical committee at LRSInstitute of Tuberculosis and Respiratory Diseases. A writteninformed consent was obtained from every patient beforecollecting data according to the Hindi translation ofinternationally accepted illness behaviour questionnaire(IBQ) (e.g. "Do you worry a lot about health?”). In order tohave a valid estimation of the illness behavior due to lowsocioeconomic condition of tuberculosis patients an equalnumber of patients of same age and sex matched control werealso given the IBQ as some degree of illness behavior may beseen in them too. During the study period of four months(January 2010 to April 2010) complete addresses ofpatients/attendees were recorded from out-patient register.The data was fed into the computer programme SPSS and oddRatios (OR) along with Confidence intervals (CI) and p-valuewere calculated for all the items to find out difference betweencases and controls, if any.RESULTS AND DISCUSSION1. Distribution of Illness behavior in group I and IIpatients according to genderThe distribution of the patients (Table 1) according to gendershows that 59 (71.95%) were male as compared to 23(28.05%) were female TB patients. The Indian society is maledominant where more male are working as compared toTable 1: Distribution of Illness behavior in group I and IIpatients according to genderGroup Male no. of Female No. of Total No. ofpatients(%) patients(%) patients(%)Group I 59(71.95) 23(28.05) 82(100)Group II 59(71.95) 23(28.05) 82(100)Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 46

Munsab Ali - Associated socioeconomic status with illness behavior in tuberculosis patients undergoing DOTS therapyfemale in the family and come in contact with undiagnosedTB patients at their working place and during the travel.Perhaps the reason why more men than woman get TB isbecause they work and live in crowded and unsanitary22conditions.2. Distribution of Illness behavior in group I and IIpatients according to educationTable 2 shows the distribution of TB patients according totheir education status. As per the RNTCP Report, TB is mostprevalent in less educated and poor people. Education playsan important role to change the patient's health behavior byproviding them with information that motivate them to follow12the treatment plan. Tuberculosis was observed in primaryschool educated people which is more (57.32%) as comparedto graduate (3.66%) and none in post graduation and abovequalified patients. So the illness behaviour is more in lesseducated people.3. Distribution of Illness behaviour in group I and IIpatients according to occupationTable 3 indicates the distribution of TB patients as peroccupation. According to RNTCP Report, TB is mostlyprevalent in less educated and poor people, similarly illnessbehaviours were observed highest in unskilled worker(36.59%) too and in semiskilled worker is (29.27). Lowoccupation status was associated with poor physical healthand a poor coping style was associated with psychiatricillness. Therefore, the illness behavior is inverselyproportional to better occupation of patients. A positivecorrelation between occupation and occurrence of depressionhas also been observed by Natani et al., 1985.4. Distribution of Illness behavior in group I and IIpatients according to family incomeTable 4 represents the distribution of TB patients according toincome of the family. According to RNTCP Report, TB ismost prevalent in low income peoples. In the present study TBis most common in patients who have family income betweenRs. 2,041 to Rs. 6,100 (53.66%) than in patient who haveincome between Rs.6,101 to Rs.10,161 (28.05%). As theincome per month increases the illness behaviour ratedecreases. A reduced status in the family and their smallcontribution to family income, due to ill-health, may be theTable 2: Distribution of Illness behaviour in group I and II patients according to educationGroup Professional Graduate Intermediate/ High school Primary school Illiterate Totaldegree PG & Postabove high schoolNo. of Patients No. of patients No. of patients No. of patients No. of patients No. of patients No. of patients% (%) (%) (%) (%) (%) (%)Group I 0(0) 3 (3.66) 8 (9.75) 20 (24.39) 47 (57.32) 4(4.88) 82(100)Group II 2(2.44) 6(7.32) 14(17.07) 24(29.27) 34(41.46) 2(2.44) 82 (100)P< 0.05, statistically significantTable 3: Distribution of Illness behaviour in group I and II patients according to occupationGroup Professional Semi Clerk, shop Skilled Semi Unskilled Unemployed Totalprofessional owner, worker skilled worker workerfarm ownerNo. of No. of No. of No. of No. of No. of No. of No. ofPatients % Patients (%) Patients (%) Patients (%) Patients (%) Patients (%) Patients (%) Patients %Group I0(0) 1(1.22) 8(9.76) 14(17.06) 24(29.27) 30(36.59) 5(6.10) 82(100)Group II0(0) 0(0) 10(12.19) 31(37.80) 26(31.71) 11(13.42) 4(4.88) 82(100)P< 0.05, statistically significantTable 4: Distribution of Illness behaviour in group I and II patients according to family incomeGroup >40,407 20,361 to 15,281 to 10,161 to 6,101 to 2,041 to

Munsab Ali - Associated socioeconomic status with illness behavior in tuberculosis patients undergoing DOTS therapy23reasons for their frustration and dissatisfaction. Thus, illnessbehaviour is inversely related to income per month.CONCLUSIONThe present study concludes that the illness behavior is mostprominent in male gender patients. Frequency of tuberculosiswas found to be decreased very rapidly as the degree ofeducation increases and was zero in case of postgraduates.Occupation status has a great role in illness behavior as thelow occupation status triggers the obsession. The per capitaincome of an individual has great impact on his social status aswell as satisfaction. Thus, socioeconomic status has atremendous role in illness behaviour of tuberculosis patientsundergoing DOTS therapy.ACKNOWLEDGMENTSAuthors are highly thankful to medical and DOTS providerand social workers of the DOTS Centre for their enthusiasticcooperation. We are also thankful to Mr. Brijesh for hisvaluable contribution and Sanjay Saroj, Babita for theirsecretarial help. We are very grateful to the projectcoordinator and staff of all the centers of LRS Institute fortheir full cooperation and support.REFERENCES1. Dye C, Scheele S, Dolin P, Pathania V, Raviglione MC.Consensus statement. Global burden of tuberculosis:estimated incidence, prevalence and mortality by country. WHOGlobal Surveillance and Organization project. JAMA 1999;282:677-86.2. Epidemiology, strategy, financing: WHO report, Geneva: WorldHealth Organization; 2009 (WHO/HTM/TB/2009.411).3. RNTCP Communication Strategy for a health. Published byCentral TB Division Directorate General of Health ServiceMinistry of Health and Family Welfare Government of India,2008.4. Global Tuberculosis Control Report 2009, Available from; URL.http: //www.who.int/tb/ Publications/ global_report/2009/pdf/full_ report. Pdf. Accessed November 30, 2009.5. http://www.tbcindia.nic.in/pdfs/TB%20India%202009.pdf.6. Chauhan, L.S, Agarwal, S.P. Revised national TuberculosisControl Programme. Tuberculosis in India chapter 3, 2008: 23-34.7. Tones K. Health education, behaviour change and publicrdhealth. Oxford textbook of public health (ed. 3 ), vol 2, NewYork: Oxford University Press, 1997: 786.8. Rabin D, Schach E. Medicaid, Morbidity and Physician. MedicalCare 1975; 13:68-73.9. Yee D, Valiquette C, Pelletier M, Parisien I, Rocher I, Menzies D.Incidence of serious side effects from first- line antituberculosisdrugs among patients treated for active tuberculosis. Am JRaspir Crit Care Med 2003; 167:1472-7.10. Yamada S, Caballero J, Matsunaga DS, Agustin G, Magana M:Attitudes regarding tuberculosis in immigrants from thePhilippines to the United States. Fam Med 1999; 31:448-77.11. Peterson TJ, Castle White M, Young JA, Meakin R, Moss AR:Street talk: knowledge and attitudes about tuberculosis andtuberculosis control among homeless adults. Int J Tuberc LungDis 1999; 3:528-33.12. Babcock DE and Miller MA. Client Education: Theory andpractice. Baltimore: Mosby Year Book Inc.; 1994.13. Kunik ME, Roundy K, Veazey C, et al. Surprisingly highprevalence of anxiety and depression in chronic breathingdisorders. Chest 2005; 127(4):1205-11.14. Aydin IO, Ulusahin A. Depression, anxiety, comorbidity anddisability in tuberculosis and chronic obstructive pulmonarydisease patients: Applicability of GHQ-12. Gen Hos Psych2001; 23(2):77-83.15. Dubey KK, Bhasin SK, Bhatia MS. Psychological reactionsamongst patients, their familymembers and the communityregarding hospitalized tuberculosis patients in Delhi.Psychiatry Today 1998; 11:30-3.16. Moudgil AC, Persadh D. Psychosocial survey of tuberculosispatients in a sanatorium. Indian J Tub 1972; 19:34-7.17. Natani GD, Jain N.K, Sharma TN et al. Depression intuberculosis patients: correlation with duration of disease andresponse to anti-tuberculous chemotherapy. Indian Journal ofTuberculosis 1985; 32(4):195-8.18. Lorant V , Deliège D, Eaton W, Robert A, Philippot P, AnsseauM. Socioeconomic Inequalities in Depression: A Meta-Analysis.American Journal of epidemiology 2002; 157:98-112.19.20.Marmot M, Feeny A. General expression for social inequalitiesin Health. IARC Sci Public 1997; 38:207-8.Prescott E, Vestbo J. Socio economic status and chronicobstructive pulmonary disease. Thorax 1999; 5:737-41.21. Akhtar S, White F, Hassan R et al. Hyperendemic pulmonarytuberculosis in peri-urban areas of Karachi, Pakistan. BMCPublic Health 2007; 3(7):70.22. Bobbin, C. Pathological Basis of Disease, New York,Saunders.1984.23. Arora VK, Johri A, Verma RP. Post treatment adjustment problemand coping mechanism in pulmonary tuberculosis patients. IndJour Tub 1992; 39:181.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 48

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaPrescription Monitoring Study of Antipsychotic Drugs in Geriatric Population atTertiary Level Referral Hospital in Rural India.Dilip. C*, Dinesh K. M. K, Divya R and Lisa M.MAl Shifa College of Pharmacy, Kizhattur, Perinthalmanna, Kerala-679325A B S T R A C TSubmitted: 02/06/2012Accepted: 12/08/2012An attempt was made to assess the prescription monitoring pattern of anti-Psychotic drugs in geriatric patients treated at tertiary level referralhospital and to rationalise the prescription habits of the clinicians. The study was conducted in tertiary level multispecialty referral hospital atPerinthalmanna. It was a prospective and observational study conducted among inpatients for four weeks by monitoring the case sheets andpatient interview in the hospital. The study was conducted to systematically assess the prescribing patterns of antipsychotic drugs amonggeriatric inpatients. A total of 65 geriatric patients were admitted to the hospital during the study period. . The indicator-driven analysis ofantipsychotic prescribing quality revealed a need for improvement, with the main prescribing problems relating to duration and combination oftherapies.INTRODUCTIONThe antipsychotics are indicated for treating psychoticdisorders, including schizophrenia, delusional disorder, andpsychotic symptoms in mood disorders and for a number oforganic psychoses. Antipsychotic drugs are among the mostwidely prescribed psychotropic medications for elderly1people. The rapidly expanding field of psychopharmacologyis challenging the traditional concepts of psychiatrictreatments, and research is constantly seeking new andimproved drugs to treat psychiatric disorders. In this way,psychiatrists are continuously exposed to newly introduceddrugs that are claimed to be safer and more efficacious. Drugprescribing forms an important part of medical treatment.There have been many overseas studies on prescribing pattern2of doctors. The number of persons above the age of 60 yearsis fast growing, especially in India. India as the second mostpopulous country in the world has 76.6 million people at orover the age of 60, constituting about 7.7% of totalpopulation. The problems faced by this segment of thepopulation are numerous owing to the social and culturalchanges that take place within the Indian society. Evaluationof the morbidity profile among elderly people, and the impactof chronic conditions on functional disability andpsychological well-being are an essential part ofcomprehensive assessment of the elderly. It will haveimplications for providing health care for the elderlypopulation and its costs. Increasingly, atypical antipsychoticAddress for Correspondence:Dilip. C, Asst professor, Al Shifa College of Pharmacy, Kizhattur,Perinthalmanna, KeralaE-mail: dillu7@rediffmail.comdrugs are prescribed for elderly patients with symptoms ofpsychosis and behavioural disturbances. Although nonpharmacologictreatments for behavioural disturbancesshould be tried first, medications often are needed to enablethe patient to be adequately cared for. Treatment withantipsychotics is very common in the elderly and oftenindispensable. However, for successful treatment, it isessential to have an adequate multidimensional assessment ofthe geriatric patient and of his or her polypathology andpolypharmacy, together with knowledge of age-dependentpharmacokinetics and pharmacodynamic changes and drug-3drug interactions.A Prescription Monitoring Program typically refers to a staterunprogram (in the United States) that serves as a registry totrack prescriptions for controlled substances. These servephysicians who want to know if his or her patient is receiving4similar medications from other physicians. Pharmacies thatdispense controlled substances are usually required to registerthe filling of such prescriptions with a state-run database Drugutilization audits are qualitative assurance programs to ensurethat drugs are used correctly and safely. The nature of suchaudits can be quantitative or qualitative or combination ofboth. Quantitative audits are concerned with quantifyingvarious facts of drug therapy use within a healthcare systemareas group whereas qualitative audits compare drug use orpractice with predetermined standards or criteria. The presentstudy was an attempt to asses drug utilization in psychotictherapy in patients above 60 years and also to know about thedaily activities of the patients by documenting in the standardscale of “Lawton Brody Instrumental Activity of Daily Living5Scale”. Here an attempt was made to assess the prescriptionmonitoring pattern of anti-Psychotic drugs in geriatricIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 49

Dilip .C - Prescription Monitoring Study of Antipsychotic Drugs in Geriatric Population at Tertiary Level Referral Hospital in Rural India.patients treated at tertiary level referral hospital, to rationalisethe prescription habits of the clinicians and to assess aperson's ability to perform tasks such as using a telephone,doing laundry and handling finances, using the “LawtonInstrumental Activity of Daily Living Scale”.OBJECTIVE:To assess the prescription monitoring pattern of anti-Psychotic drugs in geriatric patients treated at tertiary levelreferral hospital and to rationalise the prescription habits ofthe clinicians. To assess a person's ability to perform taskssuch as using a telephone, doing laundry and handlingfinances, using the “Lawton Instrumental Activity of DailyLiving Scale”.METHODOLOGYA prospective study done in the psychiatric department of thetertiary level multi-speciality hospital situated in Malabarregion of Kerala, which covers a period of three weeks in themonth of December. We have included the followinginclusion and exclusion criteria for the study.Inclusion criteria:Ÿ Patients who were diagnosed as psychiatric patients.Ÿ All the patients who were admitted in the psychiatricdepartmentŸ Persons who were taking antipsychotic drugs for > 2yearsŸ All the inpatients of age ≥ 55 yearsExclusion criteria:Ÿ Patients below 50yrsŸ Out patientsŸ Patients who were taking antipsychotic drugs prescribedfrom outside the hospitalŸ Discharged prescriptionŸ Prescription containing incomplete informationIt was a prospective and observational study conductedamong inpatients for three weeks by monitoring the casesheets and patient interview in the hospital. The dailyactivities of the patients were documented in the standardscale of “Lawton Brody Instrumental Activity of Daily LivingScale”. All the enrolled patients who met the criteria werefollowed on the daily basis from the date of admission to tillthe day of discharge to note the antipsychotic medicinesprescribed. Prescriptions were collected from the case sheetcontaining at least one antipsychotic drug, multiple drugs etc.The drug usage pattern was analysed in terms of individualdrug, its class and dosing regimen such as route, frequencyand duration of therapy was calculated. Patients admitted tothe hospital were reviewed on the daily basis. Any change inthe dose of drug, addition of drug or changes in theprescription were noted during the study. The addition ofanother antipsychotic drug to or any change to theantipsychotic drug was considered as separate prescription.All the prescriptions were throughly checked with standardprescribing guidelines for the antipsychotic drugs for theirrational use of drugs. Patient demographic details such asage, sex, occupation, educational status, height and bodyweight, clinical status such as comorbidities, reason foradmission, provisional diagnosis were collected. Thepatient's interview was done on the daily basis and the detailswere collected regarding the changes or difficulties that theyface in daily life, because of taking antipsychotic drugs. Foreg: difficulty in remembering the names of the relatives,patients feeling loneliness , difficulty in doing the usual dailyworks, fear to travel alone etc. The necessary and relevantdata collected were documented in a suitably designed datacollection form. The daily activities of the patients weredocumented in the standard scale of “Lawton BrodyInstrumental Activity of Daily Living Scale”. By using thisscale we assessed whether antipsychotic medications affectedthe normal activity of the patients. Values were expressed asmean (± standard deviation or as percentage).RESULTS AND DISCUSSIONA prospective observational study was conducted in a tertiarylevel referral hospital with more than 60 consultants ofnational reputation. During the study 65 elderly patients wereselected which who met the inclusion criteria. The study wasconducted to systematically assess the prescribing patterns ofantipsychotic drugs among geriatric inpatients. A total of 65geriatric patients were admitted to the hospital during thestudy period. Of the total admission 27(41.53%) were femaleand 38(58.46%) patients were male. Out of 65 patients41.53% had high school education and about 47.6% ofpatients had education below high school. 10.76% of patientswere uneducated. Majority of the patients (63.07%) werefound to be from middle class followed by (29.23%) fromhigh class and (7.69%) were from low class. Out of 65patients, 17(26.15%) patients were from orthopaedicdepartment, 15(23.076%) patients each from generalmedicine and neurology. Patients from cardiology,pulmonology and gastroenterology were 8(12.3%), 1 (1.5%)and 2(3.1%) respectively followed by general surgery,nephrology, and urology 2(3.1%), 4(6.15%), and1(1.53846%) respectively. Patient's ability assessment (usingLawton Brody Instrumental Activities of daily living scale):In this study, it was found out that, around 29% of patientswere taking antipsychotic drugs and most of these patientswere 60-65years age. Assessment of person's ability toperform daily activities was done using 'Lawton BrodyIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 50

Dilip .C - Prescription Monitoring Study of Antipsychotic Drugs in Geriatric Population at Tertiary Level Referral Hospital in Rural India.Instrumental Activities of daily living scale'. According to thescale, ability of the patients to use telephone was found to be58(89.23%), shopping-19(29.23%), food preparation3(4.61%), housekeeping 32(49.23%), laundry 22(33.84%),mode of transportation 32(49.23%), responsibility formedication 16(24.61%), ability to handle finance36(55.38%).Inappropriate use of antipsychotics in geriatricsmay result in decreased patient's ability to perform dailyactivities.Majority of patients receiving anxiolytic drugs werefound to be 10(15.3846%), followed by antidepressant drugs5(7.692%) and antipsychotics 4(6.1538%).Most of thepatients enrolled in this study had diabetes (19) andhypertension (31). Patients with co-morbidities like epilepsy,cirrhosis, UTI, Parkinsonism were 2 each and patients withCOPD and CAD were 6 each respectively. The other comorbiditieswere dementia, MI, TB, anaemia,hypothyroidism, osteoarthritis.Rational prescribing was followed as per the principles ofprescription writing. There was no polypharmacy, becausethere was no prescription that does not match the diagnosis.No fixed combinations or injections were given to thepatients. Most of the prescription had one or twoantipsychotic drugs. The problem we found that cliniciansdrug of choice was not always affordable by the patientsFig.3: Socioeconomic Factors of total patients in maleand female30252015105041Low class Middle class High classFig. 4: Department wise distribution of total patientsUrologyNephrologyGeneral SurgeryGastroetrologyPulonologyGeneral MedcineCardiologyNeurologyOthers1122424817MaleFemale0 5 10 15 20101515917Fig.1: Sex wise distribution of total patientsFig.5: Lawton Brody Instrumental Activities of DailyLiving ScaleAbility to handle finance36Responsibility for own16Male 58%Female 42%Mode of TransportationLaundry2232House keeping32No. of PatientsFood paration3Shopping19Ability to use telephone5820 40 60 80Fig. 2: Education wise distribution of the total patients inmale and female2019Male Female18Fig. 6: Number of patients taking Anti-Psychotic drugs fromtotal number of drugs16141210864206107871052Patients takingantipsychoticdrugs 29%Patients not takingantipsychoticdrugs 71%LP UP HS Professional UneducatedIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 51

Dilip .C - Prescription Monitoring Study of Antipsychotic Drugs in Geriatric Population at Tertiary Level Referral Hospital in Rural India.Table 1: Co- morbidities present in total patientDiseasesNo. of patientDiabetes 19CAD 6Hypertension 31UTI2Anaemia 1Hypothyroidism 1Renal failure 3Osteoarthritis 1Asthma 3Parkinsonism 2COPD 6Dementia 1Epilepsy 2Tb 1Cirrhosis 2MI 3Psychosis 3because the cheapest drug was not always prescribed. Thepercentage of drugs prescribed which are approved by WHOessential drug list are low.CONCLUSIONThe assessment of prescription pattern of anti-psychoticdrugs in geriatric patients at tertiary level referral hospital andtheir ability to perform daily activities was done using“Lawton Brody Instrumental Activities of daily living scale”.In-appropriate or long term use of antipsychotics in geriatricsresults in decreased patients' ability to perform dailyactivities. In geriatrics, who have multiple Co-morbidities,complex chronic condition and are usually receiving polypharmacy, are at increased risk for adverse drug events. Theindicator-driven analysis of antipsychotic prescribing qualityrevealed a need for improvement, with the main prescribingproblems relating to duration and combination of therapies.The clinicians can improve the prescription pattern byawareness about the choice of drug from the WHO essentialdrug list and thereby reduce the prescribing of sedative andhypnotics in geriatric patients which makes them more weakto do their daily activities.REFERENCES1. Gary. A. Ford et.al, Anti-Psychotic Drug Use in Older Patients,British Geriatric society. 2002: 225-6.2. Valiyeva et al. Effect of regulatory warnings on antipsychoticprescription rates among elderly patients with dementia: apopulation-based time-series analysis. Canadian MedicalAssociation Journal, 2008; 179 (5): 438 DOI: 10.1503/cmaj.0715403. Knol W. et. al. Antipsychotic drug use and risk of pneumonia inelderly people. J Am Geriatr Soc. 2008 April; 56(4):661-6. E pub2008 Feb 7.4. Charles D. Motsinger, Use of atypical antipsychotic drugs inpatients with dementia. am fam physician. 2003 jun1;67(11):2335-41.5. Elmiria Valiyeva PhD et.al. Effect of regulatory warnings onantipsychotic prescription rates among elderly patients withdementia: a population-based time-series analysis, CMAJ.August 26, 2008 ;179 ;5Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 52

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaA Hospital Based Crosssectional Study on Early and Late onset Psoriatic Patients1 1 2Deepthi E , Vijayakumar S* and Ramchander D1Department of Pharmacy Practice, MGM Hospital, Warangal, A.P2Department of Dermatologist, MGM Hosptial / KMC, A.PA B S T R A C TSubmitted:Accepted:Psoriasis is a common, chronic disfiguring inflammatory disease of the skin characterized in most cases by well defined scaly, red and indurateplaques mainly over extensor surfaces but also often involving other areas of the body. Although there are several studies investigatingoxidant/antioxidant systems and lipid profile in psoriatic patients, the data obtained from these studies is not concordant. In this study,Malondialdehyde (MDA), Glutathione (GSH), Total antioxidant status (TAS) in fourty patients with psoriasis were investigated and compared withthose of forty Control subjects. Clinical severity of the disease was determined according to the Psoriasis Area and Severity Index (PASI) scores inthe patients. Plasma MDA levels were significantly higher (p= 0.0119) whereas TAS and GSH levels were lower, in patients than control subjects(p= 0.0001 and p= 0.0001 respectively). There was no correlation between PASI scores and plasma MDA, GSH, TAS levels. Our findings mayprovide some evidence for a potential role of increased ROS production and decreased antioxidant activity in psoriasis. Whereas, serum Albuminand Calcium levels in psoriatic patients were found to be lower than control subjectsINTRODUCTIONPsoriasis is a common, chronic inflammatory skin disease1,2with unknown etiology. ROS that originate in theenvironment and skin may damage cell compounds such asprotein, lipid and DNA. A complex of human antioxidantenzymes catalyses the reaction of ROS scavenging these areglutathione peroxidase, total antioxidant status, catalase,superoxide desmutase. Studies on antioxidant enzymeactivity demonstrate the participation of ROS in tissue lesionprocesses esp., in chronic inflammatory process results in3increased lipid peroxidation and formation of MDA. Ourpresent study is to investigate different parameters in earlyand late onset psoriatic patients.MATERIALS AND METHODSThis cross sectional study is carried out at tertiary carehospital from December 2010 to October 2011 data wascollected from Dermatology unit at Mahatma GandhiMemorial Hospital (MGMH) Warangal, India. Thisdermatology unit has inpatient and outpatient clinic. Duringthe study period all the patients with clinical diagnosis ofpsoriasis were included, in case of uncertain diagnosis orAddress for Correspondence:Pravinkumar V. Ingle, Assistant Professor, Department of Clinical Pharmacy,R. C. Patel Institute of Pharmaceutical Education & Research, Shirpur-425405, Dist: Dhule, Maharashtra, India.E-mail: prabhu4ever2000@rediffmail.comincomplete information were excluded. The research andethical committee of concerned hospital approved thestudied. The participating clinical pharmacist were asked tofill a specially designed pre-tested questionnaire about allpsoriatic patients includes sex, age, onset of psoriasis, familyhistory, history of nail-joint involvement, clinical signs andseverity of psoriasis and clinical site involvement, involvedand uninvolved area of the skin ( nail, genital area, scrotum).Severity of psoriasis was estimated by PASI (psoriasis areaseverity index). The clinical signs of nail involvement inpsoriasis pitting, onycholysis, oil drop sign, andhyperkeratosis were also reported in the studied.Data were analyzed and managed using Graph pad prismversion 5. Blood samples of case and control group weredrawn into EDTA vials and centrifuged for about 20 to 30 minat 3000 rpm and plasma samples were stored at -20ºc untilanalysis. The amount of lipid peroxidation produced in theserum/plasma samples were estimated by the thiobarbituricacid reactive substances (TBARS) method carbonueau et al;by spectrophotometrically at 532nm. The results werepresented in nanomoles of MDA per ml of serum/plasma.Glutathione forms a light yellow colored complex with1DTNB 5-5 (dithiobis-2-nitrobenzoic acid) which is measuredspectrophotometrically at 412nm (George ellman; 1959;Beultar et al; 1963). The results were presented in µmole ofglutathione per ml of serum/plasma. Total anti-oxidant statuswas estimated by using DPPH (∞ , ∞ -diphenyl β –picrylhydrazyl ) at the concentration of 0.2Mm in methanol, whoseIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 53

Vijayakumar S - A Hospital Based Crosssectional Study on Early and Late onset Psoriatic Patientsabsorbance was read at 517nm (Blios 1958, Kalpana et al;2001). The results were presented in terms of nmole ofascorbic acid. Calcium forms a purple colored complex witho-cresolphthalein complexone whose intensity is measuredby spectrophotometrically at 570nm. The results wereexpressed in terms of mg/dl. Albumin forms green colorcomplex with BCG (bromo cresol green) whose absorbanceis measured at 630nm spectrophotometrically. The resultswere expressed in terms of gm% of albumin. Lipid profilewas estimated by using chemical kits.RESULTSAmong 40 patients 22 (55%) were male and 18 (45%) female.The mean age of the patients was found to be 43.05±17.7years (SEM=2.79) with a range of 7-70yrs. The mean age ofcontrols was 43.93±17.52 years (SEM=2.77), out of which23(57.5%) were male and 17(42.5%) female. There was nosignificant difference in the mean age between gender.Majority of the patients were in age groups of 40-50 years.The results of the plasma level of lipid profile, serum albuminand calcium in psoriatic patients and healthy controls aresummarized in table 1. Statistically increased level of lipidprofile was noted on psoriatic patients; whereas serumalbumin and calcium levels were statistically lower thancontrol group. The mean serum values of MDA, GSH, andTAS in psoriatic patients and control group were summarizedin table 2. Statistically increased levels of MDA in psoriaticpatients were noted. Among different signs of nailinvolvement (pitting, onycholysis, hyperkeratosis, and oildrop sign) in majority of 19 patients (47.5%) pitting is thecommonest sign reported in psoriatic patients as shown inTable 1: Metabolic parameters in Control Vs CaseParameter (Normal Range) Control P-valueTGS (50-150 mg/dl) 118.3±4.407 186.7±10.34****VLDL (6-40 mg/dl) 23.15±0.86 37.32±2.0****LDL (0-100 mg/dl) 49.74±3.0 102.8±6.6****HDL (40-60 mg/dl) 50.13±1.3 35.10±1.7***TC (

Vijayakumar S - A Hospital Based Crosssectional Study on Early and Late onset Psoriatic PatientsMaccarrone et al., 1997. Over production of ROS because ofchronic inflammatory and decreased activity of antioxidantsmay play a significant role in the pathogenesis of psoriasisand probably in the increased risk of cardiovascular disordersin psoriatic patients, Increased ROS levels are reflected byhigher plasma MDA levels and decreased anti-oxidantactivity determined by AOP (anti-oxidant potential) levels onpatients with psoriasis, independent from the severity ofdisease as expressed by PASI score is reported by Baz K et al.,72003. ROS produced during the inflammatory process inpsoriasis may result in increased lipid peroxidation; thisprocess may lead to cell damage. It's also responsible for adecrease in the cAMP / cGMP ratio leading to epidermal8hyperproliferation Papor et al., 1991, Raynaud F et al., 1997 ,9Briqanti S et al., 2003 . However Yildrim et al., 2003 didn'tdetect any difference in serum MDA levels in psoriaticpatients compared to controls. Our data showed that reducedhigh density lipoproteins (HDL) levels and increasedtriglycerides (TG's), total cholesterol (TC), very low densitylipoproteins (VLDL), and low density lipoproteins (LDL),levels in psoriatic patients are similar to the results reported10 11by Hamid A etal., 2009 and Akhyani M et al., 2007. Theseverity of psoriasis is calculated by PASI score. Althoughscore gives a fair assessment of disease severity as reported by5Amer ejaz et al., 2009 , our present study also complies withthe author.Nail changes in psoriatic patients is reported in present study.We could elicit nail changes in psoriasis have been reportedrd 12, 13upto 2/3 of the patients . A limitation of the study waspositive correlation between nail and joint involvement has14been found by many authors ; in the present study we havenot seen an overall positive correlation between nail and joint.Generalized psoriasis was commonest clinical type seen in15,16psoriatic patients which is in contrast to the earlier reportsno significant relationship could be established between the17,18age of onset and clinical forms of disease. This finding isconcordance with earlier studies.To the best of our knowledge, our study is first to report serumalbumin and calcium levels and first to report clinical signs ofnail involvement in psoriatic patients.CONCLUSIONThis study finding suggests that decreased calcium, albuminlevels and antioxidant capacity may be involved in thepathogenesis of psoriasis. Furthermore, this work strengthensthe association between number of patients, antioxidantsupplementation, periodical lipid profile check up,pharmacogenomic studies and innovation of newer moleculefor the treatment of psoriasis.REFERENCES1. Baker BS, FryL. The immunology of psoriasis. Br J Dermatol1992; 126:1-9.2. Ortonne JP. Recent developments in the understanding of thepathogenesis of psoriasis. Iranian J of Dermatology 1999;140:1-7.3. Soheli Nasiri et al .Interplay among anti oxidants and oxidants inpsoriasis. Iranian J of Dermatology 2009; 12:56-9.4. Michael Traub et al. Alternative Medicine ReviewPathophysiology, Conventional, and Alternative Approaches toTreatment 2007; 12:319-30.5. Amer Ejaz. Presentation of early onset psoriasis in comparisionwith late onset psoriasis: A clinical study from Pakistan. Indian JDermatol Venereol Leprol 2009; 75:36-40.6. Trouba KJ, Hamadeh HK, Amin RP, Germolec DR. Oxidativestress and its role in skin disease. Antioxid Redox Signal 2002;4:665-73.7. Baz K, Cimen MY, Kokturk A. Oxidant/antioxidant status inpatients with psoriasis. Med J 2003; 30:987-90.8. Briqanti S, Picardo M. Antioxidant activity, lipid peroxidation andskin diseases. What's new? J Eur Acad Dermatol Venereol2003; 17:663-9.9. Raynaud F, Evain-Brion D, Gerbaud P. Oxidative modulation ofcyclic AMP-dependent protein kinase in human fibroblasts:possible role in psoriasis. Free Radic Biol Med 1997; 22:623-32.10. Akhyani M, Ehsani AH, Robati RM, Robati AM. The lipid profilein psoriasis:a controlled study. J Eur Acad Dermatol Venereol2007; 21:1330-2.11. Amina HAA. Biochemical changes in psoriasis. The Middle Eastjournal of internal medicine 2010; 3.12. Sadek HA, Abdel-Nasser AM, El-Amawy TA, Hassan SZ.Rheumatic manifestations of psoriasis. Clin Rheumatol 2007;24:488-98.13. Al-Mutairi N, Manchanda Y, Nour-Eldin O. Nail changes inchildhood psoriasis: A study from Kuwait. Pediatr Dermatol2007; 24:7-10.14. Serarslan G, Gular H, Karazincir S. The relationship betweennail and distal phalangeal bone involvement severity in patientswith psoriasis. Clin Rheumatol 2007; 26:1245-7.15. Siow KY, Safder NA, Chong KH, Chua KB. A clinical appraisal ofpatients with psoriasis treated in Seremban General Hospital,Malaysia. Med J Malaysia 2004; 59:330-4.16. Kaur I, Handa S, Kumar B. Natural history of psoriasis: A studyfrom the subcontinent. J Dermatol 1997; 24:230-4.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 55

Vijayakumar S - A Hospital Based Crosssectional Study on Early and Late onset Psoriatic Patients17. Ferrandiz C, Pujot R, Garcia-Patos V, Bordas X, Smandia JA.Psoriasis of early and late on set: A clinical and epidemiologicstudy from spain. J Am Acad Dermatol 2002;46:867-73.18. Fan X, Yang S, Sun LD, Liang YH, Goa M, Zhang KY, et al.Comparision of clinical features of HLA-CW*0602-positive andnegative psoriasis patients in a Han Chinese population. ActaDermatol Venerol 2007; 87:335-40.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 56

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaPrevalence of Metabolic Syndrome in Psychiatric Outpatients in a Tertiary CareHospital, Kerala.1 2 3Linu Mohan P* , Jishnu NA , Remya PJ1,3Department of Pharmacy Practice, Al Shifa College of Pharmacy, Perinthalmanna, Malappuram (Dist), Kerala2Clinical Psychiatrist, Department of Psychiatry, Al Shifa Hospital, Perinthalmanna, Malappuram (Dist), KeralaA B S T R A C TSubmitted: 26/06/2012Accepted: 14/07/2012Psychiatric disorders are among the leading causes of global morbidity. These are often chronic and need treatment with psychopharmacologicalagents for prolonged periods often extending up to a lifetime. The bulk of the research on metabolic syndrome (MS) shows that the use of thepsychopharmacological agents. The present study was carried out at a tertiary care hospital, Perinthalmanna for eight months (Aug 2011-Mar 2012) with the aim of assessing the rate of Metabolic Syndrome in a group of psychiatric outpatients and also to determine the linkbetween Second Generation Antipsychotics and Metabolic Syndrome. Out of the 65 patients included, 25 were found to have metabolicsyndrome. The overall prevalence of MS was 38.5%. 16 patients at the first assessment and 9 at the second assessment hadmetabolic syndrome. However, the metabolic syndrome is not associated with the anti-psychotic therapy. This study shows that metabolicsyndrome was higher in patients taking resperidone 17 (68%) followed by quietiapine 10 (40%). It was concluded that the occurrence ofmetabolic syndrome is not only related to the second generation antipsychotics but also it is due to various other factors such asgenetic risk factors, increased cortisol levels, unhealthy diet (carbohydrate and fat rich diet), lack of exercise, propensity for the development ofabdominal obesity. Therefore, psychiatrists should consider measuring BP and waist circumference, two components of the metabolic syndrome,which can be easily monitored in the office setting itself. Abnormalities in either BP or waist circumference warrant screening for the othercomponents of the syndrome, more frequent monitoring of fasting glucose and lipids. If possible early interventions can be done such as dietcontrol and exercise counseling to reverse the changes.Keywords: Metabolic Syndrome, psychiatric disorders,INTRODUCTIONPsychiatric disorders are among the leading causes of globalmorbidity. These are often chronic and need treatment withpsychopharmacological agents for prolonged periods oftenextending up to a lifetime. The bulk of the research onmetabolic syndrome (MS) shows that the use of thepsychopharmacological agents, especially the newer ones, isassociated with metabolic side effects such as weight gain,1deranged glucose tolerance and lipid profile.The magnitude of public health impact of the metabolicsyndrome is reflected by an estimated prevalence ofapproximately 47 per cent in adults in the United States to211.2 per cent in a study from Chennai, India. Studying the MSis important heuristically to understand its pathophysiologyand practically to determine the appropriate use of theAddress for Correspondence:Linu Mohan.P, Asst.Professor, Dept of Pharmacy Practice,Al Shifa College OfPharmacy, Perinthalmanna, Malappuram (Dist.), KeralaE-mail: linumpharm@gmail.compsychopharmacological agents. The metabolic syndrome is aconstellation of interrelated abnormalities namely (obesity,dyslipidaemia, hyperglycaemia, and hypertension) thatincrease the risk for cardiovascular disease and type-23diabetes. It is also known as syndrome X, insulin resistance4syndrome and dysmetabolic syndrome. This is a commonmetabolic disorder which increases in prevalence as thepopulation becomes more obese. Distribution as well asamount of fat is important. The syndrome develops moreoften in people whose fat accumulates around the abdomen(called apple shape) and who have a high waist-to-hip ratio.The syndrome is less common among people whose fataccumulates around the hip (called pear shape) and who have5a low waist-to-hip ratio. The number of people withmetabolic syndrome increases with age, affecting up to 25%of the population.So, the main aim of our study was to assess the rate ofMetabolic Syndrome using International Diabetic Federation(IDF) criteria in a group of psychiatric out patients in a tertiarycare hospital at Malabar region of Kerala. As the use ofpharmacological agents causes metabolic syndrome studyIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 57

Linu Mohan - Prevalence of Metabolic Syndrome in Psychiatric Outpatients in a Tertiary Care Hospital, Kerala.also tried to determine link between use of second generationantipsychotics and metabolic syndrome along withdetermination of minimizing strategies.METHODOLOGYThis study on “Prevalence of Metabolic Syndrome inPsychiatric Out-patients” was carried out at a tertiary carereferral hospital at Perinthalmanna. It is one of the largesttertiary care teaching hospitals in south Malabar regionof Kerala. The study population included patients attendingthe psychiatric outpatient department. This study was carriedout over eight months (Aug 2011-Mar 2012). Ethicalapproval for this study was obtained from the Ethicalcommittee of the Hospital. Data were collected fromtreatment chart, personal interview with patients, personalinterview with doctors and from laboratory values.Out of the patients attending psychiatric outpatientdepartment, who were on second generation antipsychoticswere included in the study. Patient's demographic profile,psychiatric and medical histories were obtained from casenotes. Medication history was based on informationdocumented in the medical record as well as reports from thepatient. As a part of the routine admission procedure height,weight and blood pressure were recorded. The body mass2index was calculated from the weight and height (kg/m ).Biochemical parameters which include fasting blood sugar,serum triglycerides, HDL were obtained and additionallywaist circumference was recorded. All these details weredocumented in the patient data collection form.Ÿ For the prospective assessment of metabolic syndrome,the International Diabetes Federation (IDF) criterion wasused. According to IDF a person is having metabolicsyndrome when he/she has a central obesity with waistcircumference of ≥ 94 cm in men or of ≥ 80 cm inwomen; and any of the two of four other risk factors: 1)elevated serum triglycerides ≥150mg/dL (1.7 mmol/L);2) low serum HDL cholesterol

Linu Mohan - Prevalence of Metabolic Syndrome in Psychiatric Outpatients in a Tertiary Care Hospital, Kerala.HDL-c levels decreased by a value of -8.08% and themean difference obtained are 4.920 with a p-value of 0.001.Therefore HDL-c is significantly causing MS.Triglyceride level was found increased by a value of3.18% .The mean difference is -4.320 and p-value is0.001. Hyperlipidemia is one of the main features ofmetabolic syndromeDISCUSSIONRecently there has been increased concern over the sideeffects of the atypical antipsychotic drugs, including diabetes,hyperlipidemia and obesity. The relationship between thesefactors and antipsychotic drugs requires a careful analysis.Metabolic syndrome (MS) is comprised of numerous factorswhich predict the risk of CVD and diabetes, which may occurdue to number of etiological factors but particularly withantipsychotic usage.In this study among seriously mentally ill patients, 38.5% metcriteria for the metabolic syndrome as defined by IDF. Thisrate is elevated, compared with the rate of 21.4% found in6studies in United States' general population. However it iscompatible with 38% prevalence rate in a study on in patientswith severe psychotic and mood disorders. A generalpopulation study from south India using IDF criteria put the7prevalence of MS at 25.8 percent.Metabolic syndrome in this study is higher in females andmore common in middle aged (30-50 yrs) group. This is inaccordance with general knowledge that females are moreprone to metabolic disorder as compared to males. Higher agein general make people more predisposed to metabolicsyndrome. The results were similar to those of others showing8preponderance of females among those with the MS.Interestingly, there were no associations between metabolicsyndrome and various lifestyle risk factors, such as smoking,alcohol consumption etc. Family history of diabetes andhypertension is not associated with risk of developingmetabolic syndrome; this indicates that other environmentalor acquired factors relating to the mood or psychotic illnesshave more influence in the development of metabolicsyndrome than genetic factors.In this study, prevalence of metabolic syndrome is higher inbipolar patients (44%) followed by OCD (20%).As theprevalence of metabolic problems is significantly higher inbipolar patients than others, pharmacologic treatment shouldbe implemented only after consideration of metabolic riskfactors. In particular, bipolar patients beginningpharmacological treatment for acute mood episodes may bemore vulnerable to metabolic derangements, becausesignificant weight gain has been shown to occur during acutetreatment with atypical antipsychotics in combination withmood stabilizers.The other important finding in this study is that the utilizationof atypical antipsychotics (eg. resperidone, clozapine,olanzapine, quietiapine) was not significantly associated withthe occurrence of metabolic syndrome. Abdul Hamid AbdulRahman et al conducted a study and found that the metabolicsyndrome is not associated with the anti psychotic therapy9(p=0.41). Some atypical agents cause substantial metabolicadverse effects. This is of concern because of the wellestablished excess of cardiovascular morbidity and mortalityin patients with schizophrenia that predates the widespreadintroduction of atypical agents. Individual drugs havediffering propensities to cause metabolic adverse effects.Results of this study shows that metabolic syndrome washigher in patients taking resperidone 17 (68%) followed byquietiapine 10 (40%).There are several reasons why severe mood and psychoticdisorders might be associated with higher rates of themetabolic syndrome. Certain lifestyles, such as sedentaryhabits and high fat and carbohydrate diets, are common inpeople with severe mental illness and are associated with the6,9metabolic syndrome. Finally, severe mood disorders andpsychotic disorders may predispose individuals tophysiological changes that increase the rate of the metabolicsyndrome.Abnormalities of glucose regulation, with a pattern of insulinresistance, have been described in schizophrenic patientseven before the development of illness and the use of10antipsychotic agents. Genetic risk factors, increased cortisollevels, unhealthy diet, lack of exercise, propensity for thedevelopment of abdominal obesity, and antipsychotictreatment might all be common factors in the etiology ofmetabolic syndrome in people with schizophrenia and11affective disorders. In two recent studies, Thakore et al.found increased central obesity in untreated first-episode12patients diagnosed with schizophrenia or major depression.Both depression and schizophrenia have been associated withdysregulation of the hypothalamic–pituitary–adrenal (HPA)axis, which has been implicated in the development of the13metabolic syndrome.Table 1: MS -baseline And Review Comparison.Metabolic Metabolic Syndrome (review)syndrome(baseline) Yes No Total df p-valueYes 16 0 16 1 0.001(100.0%) 0% (100.0%)No 9 1 40 498.4% 81.6% 00.0%Total 25 40 6538.5% 61.5% 100.0%Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 59

Linu Mohan - Prevalence of Metabolic Syndrome in Psychiatric Outpatients in a Tertiary Care Hospital, Kerala.Table 2: Family History of Risk FactorsFamily History Metabolic Total df p-valueSyndromeHypertension 9(36.0%) 25(100.0%) 1 0.362Diabetes 8(32.0%) 25(100.0%) 1 0 .865Table 3: Social HabitsSocial Habits Metabolic Total df p-valueSyndromeSmoking 2(8%) 25(100.0%) 1 0.403Alcoholic 3 (12.0%) 25(100.0%) 1 0.800Table 4: MedicationsMedications Metabolic Syndrome df p-valueResperidone 17 (68.0%) 1 0.217Olanzapine 6 (24.0%) 1 0.755Clozapine 0 1 0.066Quietiapine 10 (40.0%) 1 0.684Atypical + valproate 13 (52.0%) 1 0.176Total 25Fig. 2: Age Wise Distribution of the PatientsFig. 3: diagnosis and metabolic syndromeFig.1: Gender Wise distribution of the Study Population.CONCLUSIONIn conclusion, this study shows that in routine practice thenatural course of metabolic syndrome in patients withpsychotic disorders is dynamic. In one year follow-up aconsiderable number (25) of patients developed metabolicsyndrome. The clinical relevance of this study's findings ishigh–a positive detection of metabolic syndrome provides abaseline from which to monitor and treat any emerging (andpotentially life-threatening) cardiovascular problems.It have also been demonstrated that measuring the criteria formetabolic syndrome is quick, simple and inexpensive.Therefore, it is proposed that the measurement of themetabolic syndrome parameters (including the recording ofwaist circumference) become routine for psychiatric patients.BPAD –Bipolar affecting disorder, SAD –Seasonal Affective DisorderOCD –Obsessive Compulsive DisorderAbnormalities in either BP or waist circumference warrantscreening for the other components of the syndrome, morefrequent monitoring of fasting glucose and lipids, and furtherinterventions such as diet and exercise-counseling to reversethe changes. All patients taking atypical antipsychotics14require monitoring of weight, fasting glucose, and lipids.Failure to monitor metabolic parameters and intervene earlymay result in continued high rates of morbidity in severelymentally ill patients secondary to complications of CVD anddiabetes. Whether as a part of the illness or its consequence(change in lifestyle) or medication, patients with severemental illnesses have a high prevalence of metabolic1syndrome. With the Indian population already susceptible todevelop metabolic syndrome, screening of larger samples ofpatient with mental disorders and those who are receivingneuroleptic medication becomes essential. With a largeproportion of the country still having limited access toprimary care and with limited availability of laboratoryinvestigations, it becomes essential to at least performphysical measures in patients on antipsychotic medication.Regular screen for metabolic disturbances where facilities areavailable should be ensured. A prudent approach to caring forpersons with major mental illnesses involves monitoringcardio metabolic risk, including measurement of baseline andIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 60

Linu Mohan - Prevalence of Metabolic Syndrome in Psychiatric Outpatients in a Tertiary Care Hospital, Kerala.Table V- Comparison of Baseline and Review Values of Various Paramerters with their Statistical Significance.Variables Sample (N) Mean SD % Mean SD of Paired df p-valuedifference difference mean t-testdifferenceBMI-I 25 26.2610 3.88526 3.14% -8.2616 .60624 -6.814 24 .001BMI-II 25 27.0872 3.72915WAIST -I(in cms) 25 92.72 7.547 3.88% -3.600 2.179 -8.259 24 .001WAIST-II (in cms) 25 96.32 7.936SBP-I 25 126.40 9.522 2.84% -3.600 9.522 -1.890 24 .071SBP-II 25 130.00 2.887DBP-I 25 83.80 6.964 6.92% -5.800 7.455 -3.890 24 .001DBP-II 25 89.60 3.202TG-I 251 35.561 4.480 3.18% -4.320 5.460 -3.956 24 .001TG-II 25 139.88 16.435HDL-I 25 60.88 10.822 -8.08% 4.920 6.812 3.611 24 .001HDL-II 25 55.96 13.043FBS-I 25 97.80 13.586 10.18% -9.960 7.202- 6.914 24 .001FBS-II 25 107.76 16.984I-baseline,15serial indicators for risk during antipsychotic treatment.Treatment of the metabolic syndrome focuses on lifestylemodifications which include dietary changes and exercise.The professionals need to be aware of the existence of themetabolic syndrome, be vigilant to its development and takeprompt steps to rectify it.REFERENCESII-review1. Mattoo SK, Singh SM. Metabolic syndrome and psychiatricdisorders. Indian J Med 2008; 237-45.2. The IDF consensus worldwide definition of the metabolicsyndrome, 2006, http://www.idf.org/webdata/docs/MetS defupdate2006.pdf (Ref type: electronic citation).3. Izet Aganovic, Tina Dusek. Pathophysiology of metabolicsyndrome. New trends in classification, monitoring andmanagement of metabolic syndrome 2006; 1:1-3.4. European Journal of Cardiovascular Prevention andRehabilitation 2003; 10:S1-S78.5. Ford ES, Giles WH, Dietz WH. Prevalence of the metabolicsyndrome among U.S. adults: findings from the Third NationalHealth and Nutrition Examination Survey. JAMA 2002; 287:356-9.6. Bermudes RA, Keck PE, Welge JA. The prevalence of themetabolic syndrome in psychiatric inpatients with primarypsychotic and mood disorders. Psychosomatics 2006; 47:491-7.7. Deepa M, Farooq S, Datta M, Deepa R, Mohan V. Prevalence ofmetabolic syndrome using WHO, ATPIII and IDF definitions inAsian Indians: the Chennai urban rural epidemiology study(CURES-34). Diabetes Metab Res Rev 2007; 23:127-34.8. McElroy Susan L, Mark Frye A, Gerhard Hellemann, LoriAltshuler, Gabriele Leverich S. Prevalence and correlates ofeating disorders in 875 patients with bipolar disorder. Jour ofAffect Disord 2011; 128:191-8.9. Hamid A, Saheera AH, Baharudin A, Sidi H. Metabolic syndromein psychiatric patients with primary psychotic and mooddisorders. ASEAN Jour of Psych 2009; 2(10);1-8.10. Kasanin J. The blood sugar curve in mental disease. Arch NeurolPsychiatry 1926; 16:414-9.11. Alexander P J, Radhakrishnan K, Milan D, Stephen C B.Prevalence of metabolic syndrome among Australians withsevere mental illness. MJA 2009; 190:176-9.12. Ryan MCM, Flanagan S, Kinsella U. The effects of atypicalantipsychotics on visceral fat distribution in first episode, drugnaivepatients with schizophrenia. Life Sci 2004; 74:1999–2008.13. Siever LJ, Davis KL. Overview towards a dysregulationhypothesis of depression. Am J Psychiatry 1985; 142:1017-31.14. Keck PE Jr, Buse JB, Dagogo-Jack S. Managing metabolicconcerns in patients with severe mental illness: a special report.Postgrad Med, McGraw-Hill, Minneapolis, MN, 2003;1-92.15. Daniel Casey E. Metabolic issues and cardiovascular disease inpatients with psychiatric disorders. The American Journal ofMedicine 2005; 118:15-22.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 61

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaAssessment of Drug Prescribing Patterns in Dermatology Outpatient Department ina Tertiary Care Hospital, Malabar, KeralaMohamed Saleem T.K*, Dilip. C and Nishad V.KAl Shifa College of Pharmacy, Kizhattur, Perinthalmanna, Kerala.Pin-679325A B S T R A C TSubmitted: 04/07/2012Accepted: 27/07/2012Skin diseases in developing countries have a serious impact on people's quality of life. Occasionally skin diseases can be a manifestation ofsystemic diseases. A prospective study was carried out over six months (August 2010-January 2011) in the Dermatology outpatient department oftertiary care referral hospital in Malabar region of Kerala. A total of 500 cases were analyzed in which the total number of drugs was found to be1230. The most commonly prescribed systemic agents were antihistamine (294) followed by antibiotics (181) & antifungal agents (49). The mostcommonly prescribed topical agents were topical steroids & its combination (236) followed by topical antifungal agents (124). This study revealsthat generic prescription is very low and suggests that effort must be made to encourage prescribers for generic prescribing which may have amultitude of benefits including cost effectiveness. Having a steroid and antibiotic prescribing policy will go a long way to minimizing inappropriateprescriptions and also standard treatment guidelines for the treatment of common disease should be formulated.Keywords: Skin diseases, dermatology,INTRODUCTIONSkin diseases in developing countries have a serious impacton people's quality of life, it is more so in India where climate,socio-economic status, religions and customs are widelyvaried in different parts of the country. Occasionally skindiseases can be a manifestation of systemic diseases.Moreover, the skin is an important target organ for HIV1, 2infection , that could be prevented or controlled by, amongother measures, appropriate use of drugs.Rational use of drugs is defined by World HealthOrganization (WHO) as “patients receive medicinesappropriate to their clinical needs, in doses that meet theirown individual requirements for an adequate period of time,3at the lowest cost to them and their community” . WHOhighlights two concomitant problems regarding the drugsituation in the developing world: one out of three peopleliving in the developing world are in need of essential drugsalthough there are concurrent higher rates of inappropriate4drug-use and drug resistance . WHO has estimated that atleast one-third of the world's population lacks access toessential drugs. In poorer areas of Asia and Africa this figuremay be as high as one-half. Millions of children and adults dieeach year from diseases that could have been prevented ortreated with cost-effective and inexpensive essential drugs.Address for Correspondence:Mohamed Saleem T.K, Assistant Professor, Al Shifa College of Pharmacy,Kizhattur, Perinthalmanna.E-mail: mohamedsaleemtk@gmail.comThe WHO also estimates that 50 percent of all medicines are5 .inappropriately prescribed, dispensed, or sold According tothe 1985 WHO Conference of Experts on drug-use,appropriate or rational use of medicines is only when drugsare prescribed when clinically indicated, and at correctdosages for the right duration and at the lowest cost both to thepatient and their community. Inappropriate drug use hasdirect and indirect cost to the health system and individuals. Itis estimated that third world countries spend 30-40% of theirtotal health budget on drugs some of which are useless andexpensive and doubles their expenditure on drugs every 4years while GNP (Gross National Product) doubles every 16years. According to planning commission paper of 2009,health care expenses were responsible over half of all casesdecline into poverty. It was estimated in 2004-05, anadditional 39 million people were pushed into poverty due toout of pocket payment. National sample survey office(NSSO) data for the same year had shown that of the totalmedical expenditure percapita, medicines alone accountedfor 74% of the expenses in the rural and 67% in urban areas. Itis more in non-government sector. It indicates huge impact ofrising price on health expenditure. This expenditure can beminimized by prescribing drugs by generic name and6selection of drugs from essential medicine list Therefore,periodic evaluation of drug utilization patterns need to bedone to enable suitable modifications in prescription of drugsto increase the therapeutic benefit and decrease the adverseeffects. People often have very rational reasons for usingmedicines irrationally. Causes of irrational use include lack ofknowledge, skills or independent information, unrestrictedIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 62

Mohammed Saleem TK - Assessment of Drug Prescribing Patterns in Dermatology Outpatient Department in a Tertiary Care Hospital, Malabar, Keralaavailability of medicines, overwork of health personnel,inappropriate promotion of medicines and profit motivesfrom selling medicines. The study of prescribing patternsseeks to monitor, evaluate and if necessary, suggestmodifications in the prescribing behavior of medical7,practitioners to make medical care rational and cost effective8.To monitor, standardize and afford Comparability of results,WHO in collaboration with the International Network for theRational Use of Drug (INRUD) developed core indicators for9assessing drug use . This study utilized these drug-use coreindicators to describe patterns of drug use at dermatologydepartment in a tertiary care hospital to provide feedback tothe prescriber and to create awareness among them aboutrational use of medicines. In this study an attempt was made toassess the drug prescribing patterns in dermatology outpatientdepartment in a tertiary care hospital and to obtaininformation on demographic characteristics of the patientsselected for analysis. Also an attempt was made to describethe patterns of prescribing practices by using WHO/INRUDdrug-use core indicators likeŸ To evaluate average number of drugs per encounterŸ To determine percentage of drugs prescribed by genericnameŸ To determine percentage of encounter with an antibioticprescribedŸ To determine percentage of drugs prescribed from WHOessential drug listŸ To determine percentage of fixed drug combination fromWHO essential drug listMETHODOLOGYA prospective study was carried out over six months (August2010-January 2011) in the Dermatology outpatientdepartment of tertiary care referral hospital in Malabar regionof Kerala after obtaining requisite permission. Hospital catersthe treatment requirement to the people from all over northKerala. Ethical approval for the study was obtained from thehospital ethical committee. Confidentiality and anonymity ofthe patients were maintained during the study. Allprescriptions issued to patients attending the dermatologyoutpatient department during this period following each day'sconsultation were copied out from the case files and recordedin data collection forms adapted from WHO guidelines on9how to investigate drug use in health facilities . Data wasobtained from a total of 500 prescriptions which includes ageand gender of the patients, the diagnosis, the drugs prescribed,their strength, frequency, route of administration and durationof treatment and the prescriptions were subjected tomeasuring the appropriateness of prescription. Misuse of anyone of these parameters was taken as indication of a problemprescription.The Prescriptions were subjected to critical evaluation usingWHO prescribing indicators.a) Average number of drugs per encounter was calculated bydividing the total number of different drug productsprescribed by the number of encounters surveyed.b) Percentage of drugs prescribed by generic name wasdetermined by dividing the number of drugs prescribed bygeneric name by the total number of drugs prescribed,multiplied by 100.c) Percentage of encounters with an antibiotic prescribedwere calculated by dividing the number of patient encountersduring which an antibiotic was prescribed by the totalnumber of encounters surveyed, multiplied by 100.d) Percentage of drugs prescribed from essential druge) Percentage of fixed-dose combination prescribedAll the findings were recorded, compiled, tabulated andanalyzed. The analyzed data were expressed in percentage.RESULTSA total of 500 cases were analyzed. The catchment area of ourhospital is Malabar region of Kerala; Fig 1 & 2 provides thegender distribution & age wise distribution of patient indermatology OPD, respectively. 248 patients (49.6%) werefound to be female followed by male, 252 patients (50.4%).The age group 20-29 yrs was accounted for the highestnumber of 125(25%) of patients. Total number of drugs in500 prescriptions was found to be 1230. Number of drugs perprescription varied from 1 to 7 with average of 2.46(Fig 3).Most of the prescription consists of minimum of 3 drugs(185prescription, 37%). Only 1% drugs were prescribed ingeneric name. Fig 4 shows the appropriateness of theprescription which indicates the good rational prescriptionhabit of the doctors. Injectables were found to be rarelyprescribed in this OPD (1 out of 1230drugs). The mostcommonly prescribed systemic agents were antihistamine(294) followed by antibiotics (181) & antifungal agents (49).The most commonly prescribed topical agents were topicalsteroids & its combination (236) followed by topicalantifungal agents (124). All systemic agents were given orallyexcept (Inj.kenacort; triamcinolone for treatment of alopeciaAreata). Major therapeutic agent found among the drugcategory is presented in Fig 6, results reveal that levocetrizinewas found to be the major drug among the antihistaminegroup, Fluconazole among antifungal, Clobetasole amongsteroidal agent and Roxithromycin was found among theantibiotic agent. Analysis of steroids revealed that 262patients require steroids and its combination with antibiotics.Out of 262 patients, 125 used very potent topical steroids(clobetasole). 86 patients got steroid combination withantibiotics. Only 25 patients got systemic steroidal therapyIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 63

Mohammed Saleem TK - Assessment of Drug Prescribing Patterns in Dermatology Outpatient Department in a Tertiary Care Hospital, Malabar, Kerala(omnacortil) (Fig7), and efficacies of these steroids arepresented in Fig 8, which shows that most of the prescriptionscome under high potency steroidal agent. Among the topicalsteroidal agent 91% of the patient got high potency steroidalagent (clobetasole). Analysis of antifungal group (Fig 9)revealed that out of 173 patients requiring an antifungal, 43patients received one topical and one oral antifungal. While14 patients got topical antifungal combination with steroids,20 patients received one topical and one oral and 90 patientsgot only topical antifungal agent, 29 patients received onlysystemic antifungal agents. Fluconazole was most commonlyprescribed because its monthly dose provides cost effectivetreatment and decrease propensity for adverse effect. FromFig 11, it can be seen that antibiotics were prescribed in 287prescriptions out of the total 500 patients, among that mostprescribed drug was Roxithromycin. Only 15 patientsreceived antibiotic combination with steroids. Most of theantibiotic prescriptions were used in case of dermatitis,Eczema, pyoderma condition. Analysis showed that about58.8 % (294 out of 500) patients received at least oneantihistamine, the two antihistamines were prescribedtogether on 4 occasions (Fig 10). Present study shows thatvitamins are usually recommended in the case ofpigmentation disorder like vitiligo, melasma etc and Vit.Acontaining topical agent were used in case of acne &ichthyosis. Among astringent category, calamine was themost commonly prescribed products. The miscellaneouscategory included NSAIDS, proton pump inhibitors,analgesic, Antiviral and antiparasitic agent agents (Fig12).study reveals that Fungal infection were the largest groupof disorder among which T.versicolor was most observedinfection agent. High incidences of Dermatitis andhypersensitivity disorder were found in our study, among thatseborrheic dermatitis was most frequently found. About 9.6%of patients reported with pigmentation disorder. Incidence ofviral infection (0.8%), parasitic skin infection (1.6%) wasrelatively low. Among the non infective skin disorder,Eczema emerged as the single largest disorder (10.0%) (Fig14).WHO/INRUD rational drug-use indicatorsWHO prescribing indicators are given in Fig 13, result revealsthat out of the total 1230 individual drugs prescribed, 13 (1%)were prescribed by generic names and about 18.78% of thedrugs were prescribed from the WHO essential drug list. Atotal of 1230 individual drugs were prescribed in 500encounters. Overall, the average number of drugs perencounter was 2.46. Analyzing for antibiotic prescriptionshowed that 287 individual antibiotics were prescribed for500 patients. Some patients had received more than oneantibiotic, as a systemic preparation in combination witheither a topical application or another systemic preparation.None of the patients received triple antibiotics. Overall, theproportions of encounters with at least one antibioticprescribed shows 23.3%. Present study shows that total of9.75 % drugs prescribed as fixed drug combination, amongthat only 0.2% accounting as essential one.DISCUSSIONIn the present study, even though the sample size was not verylarge, it gave a cross-section of patients and the diseases forwhich they reported for treatment. The disease profiledescribed in this study corresponds well with the healthstatistics from the Indian dermatology department (fungiinfection, dermatitis) accounting for most morbidity reportedfrom the dermatology outpatient department. The number ofmale patients was more than females and the ratio was more. 11than that expected from the sex ratio of other studies It isimportant to choose the right medicine(s) for a patient and inan appropriate manner in order to achieve the best results ofmedicine therapy. In our study it is heartening to note thatmore than 90 percentage of medicines, recorded route ofadministration, dose, frequency of administration andduration of treatment. This positive observation would be asign of good prescribing patterns in this dermatologyoutpatient department. The irrational use of drugs is acommon occurrence throughout the world. Average numberof drugs per prescription is an important index of prescriptionaudit. In our study the mean number of drugs per prescriptionwas found to be 2.46, it was lower than what had been12previously reported in other studies in Western Nepal and. 13other parts of India It is preferable to keep the number ofdrugs per prescription as low as possible since higher figureslead to increase risk of drug interaction, adverse effect andincreased cost to the patient. Our study reports that only 1% ofdrugs were prescribed by generic name. Our value is less than14, 15 .that reported in other studies The decreasing percentageof drugs prescribed by generic names in our hospital is amatter of concern and the reasons for these should beinvestigated. Prescribing by brand name may be an evidenceof dangerous promotional strategy by pharma companies.Our study revealed that the percentage of drugs prescribedfrom WHO essential drug list was only 20.16%, which islower compare to that of the study conducted in North India10(75-95%) . The possible reason for this lower value could bethe prescribers lacking the understanding and importance ofessential drug concept. The low rate of prescribing fromWHO essential drug list may be contributed by excessive useof antihistamines (cetrizine), antibiotics (Roxithromycin,fusidic acid) and several topical steroidal preparation whichare not included in WHO essential drug list. In the presentstudy total of 9.75% fixed drug combination were prescribed,among that only 0.2% could be considered as essential whichis much lower than what have been previously reported (39%)Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 64

Mohammed Saleem TK - Assessment of Drug Prescribing Patterns in Dermatology Outpatient Department in a Tertiary Care Hospital, Malabar, KeralaFig. 1: Gender wise distribution among the study groupFig. 5: Figure showing category wise number of drugsprescribedFig. 2: Age wise distribution among the study groupFig. 6: Figure showing major therapeutic drug prescribedFig. 3: Figure showing number of drugs per prescriptionFig. 7: Figure showing Steroid and combination prescribedFig. 4: Figure showing appropriateness of the prescription15 .in other studies in India The lower percentage of rationalFDC may be due to the most of the prescription werecombination of antifungal, antibiotic and corticosteroidswhich are not included in WHO fixed drug combination list.In this study Antihistamine, Antibiotic and Steroid&combination were the most prescribed drugs.Antihistamines were the most commonly prescribed systemicIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 65

Mohammed Saleem TK - Assessment of Drug Prescribing Patterns in Dermatology Outpatient Department in a Tertiary Care Hospital, Malabar, Keralaagents in dermatology, which is almost similar to previous12studies in Dermatology OPD of Nepal ,because most of thedermatological problem is associated with theitching(associated with fungal, scabies, eczema).Thepercentage of prescription with an antibiotics prescribed was23.3%.. Roxithromycin was the most frequently prescribedantibiotics. Fluconazole was the drug most commonlyprescribed among antifungal agents, because of its once in amonth dose schedule results in cost effective treatment and alower propensity of adverse effect. Present study reveals thatcorticosteroids were the mainstay treatment in dermatologydepartment, which indicates inappropriate utilization or overutilization.Majority of the patients got potent corticosteroids(clobetasole 48%). The quantity of the corticosteroids to beapplied was not mentioned in most of the prescription andduration of use not mentioned in 18 prescriptions, this mayresult in under utilization of the preparation and subsequentsub-therapeutic outcome. There is also the possibility of overutilization of the topical corticosteroids by the patient thussubsequent risk of hypothalamic-pituitary adrenal axissuppression. Hence, they have to be tapered or reduced tominimal dose. In our study, vitamins are mainly prescribed forthe patients having pigmentation disorder, but other studiesconducted in dermatology department had shown thatvitamins are usually recommended along with oral antibioticsto prevent vitamin deficiency associated with death of normal12microflora . Topical vitamin A derivative also prescribed inthe case of acne, and ichthyosis. Permethion was prescribed inmost of the cases with patient having scabies, though benzoylbenzoate is a cheaper alternative for treating scabies.Permethrin is found to be suitable for scabies, owing to itssingle application as compared with benzyl benzoate. Most ofthe Dermatological condition in the OPD were cutaneousinfection (38.6%) followed by hypersensitivity andinflammatory disorder (10.2%), Acne & related (9.6%),pigmentation disorder (9.6%). Thus, results of the diseasepattern showed that is similar to that in North Eastern part of16.India. The high incidence of infectious disease indeveloping countries may be related to inadequate medicalcare, poor sanitation and nutrition. In this study Eczemaemerged as the single largest disorder; similar findings are16,17also reported from other studies Fungi infections were thelargest group of disorder, the warm humid climate of theMalabar region may account for the high incidence fungalinfection. Incidence of parasitic infection and pyoderma inour study may be due to low socio-economic status andnutritional deficiency of such patients. The incidence of viralinfection was relatively low (0.8%) in our study which iscomparable to similar studies done in Northern Indian18 43(1.6%) and Trivandrum 3.10%. Only 4 patients presentedwith viral exanthemas in our study because such patientsFig. 8: Figure showing efficacy of topical steroids foundamong the prescription patternFig. 9: Figure showing antifungal and combination prescribedFig. 10: Figure showing Antihistamine drug found amongthe prescription patternFig. 11: Figure showing Antibiotic and combination prescribedIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 66

Mohammed Saleem TK - Assessment of Drug Prescribing Patterns in Dermatology Outpatient Department in a Tertiary Care Hospital, Malabar, KeralaFig. 12: Figure showing pattern of miscellaneous drug prescribedFig. 13: Figure showing WHO prescribing indicatorsFig. 14: Figure showing disease distribution among thestudy groupmainly consult the physician. None of the patients presentedwith Hansen's disease in this study is due to the fact that suchpatients mainly attend leprosy and TB centers where themedicines (MDT) are given free of cost. Our study had fewlimitations. The pharmacotherapeutic aspect of theprescription in relation to health problem or diagnosis of thepatients was not assessed. The study was carried out over asix-month period and seasonal variations in disease patternsmay not have been taken in to account. The study was carriedout during autumn-winter season. A similar study over alonger period of time which can nullify the effect of seasonalvariations should be explored further in future studies.CONCLUSIONThis study is mainly focused on the dermatological diseasepattern, prescribing pattern of drugs in Dermatologyoutpatient department. The study suggests that there isimmense scope of improvement in prescribing in thisdepartment. This study reveals that generic prescription isvery low and suggests that effort must be made to encourageprescribers for generic prescribing which may have amultitude of benefits including cost effectiveness. Thepercentage of encounters with an injection and systemicsteroids was low. This is a welcome sign and has to beencouraged. Having a steroid and antibiotic prescribingpolicy will go a long way to minimizing inappropriateprescriptions. Also, standard treatment guidelines for thetreatment of common disease should be formulated.REFERENCES1. World Health Organization. Bulletin of the World HealthOrganization vol.83: November 12, December 2005;881-968.2. Bijayanti D, Zamzachin G. Pattern of skin diseases in Imphal.Indian Journal Dermatology 2006, 51:149-50.3. Bhartiy SS, Shinde M, Nandeshwar S, Tiwari SC. Pattern ofprescribing practices in the Madhy Pradesh, India. Kathmanduuniversity medical journal 2008; 6(1)21:55-9.4. World Health Organization. The World Health Report: Fightingdisease fostering development. Geneva, World HealthOrganization 1996.5. World Health Organization. The World Medicines Situation.Geneva, World Health Organization 2004.6. Manoj KS, Ashish KY, Pankaj G, Ashish S. Comparative studyof prescribing behaviors of government doctors of teachinghospital and private practitioners in Jhalawar City (Rajasthan).J. Pharm. Sci. & Res. 2010; 2(4):208-15.7. Shankar PR, Pai R, Dubey AK, Upadhyay DK. Prescribingpatterns in the orthopaedics outpatient department in a teachinghospital in Pokhara, western Nepal. Kathmandu UniversityMedical Journal 2007; 5(1):16-21.8. World Health Organisation. Promoting rational use ofmedicines: core components. World health organization,Geneva 2002.9. World Health Organisation. How to investigate drug use inhealth facilities: selected drug indicator. Geneva, World HealthOrganisation 1993. WHO /DAP/93.1.10. Alam K, Mishra , Prabhu M, Shankar PR, Palaian S, BhandariRB, Bista D. A study on rational drug prescribing and dispensingin outpatients in a tertiary care teaching hospital of WesternNepal. Kathmandu University Medical Journal 2006; 4(4):436-443.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 67

Mohammed Saleem TK - Assessment of Drug Prescribing Patterns in Dermatology Outpatient Department in a Tertiary Care Hospital, Malabar, Kerala11. Thawani V.R., Motghare V.M., Dani A.D, Shelgaonkar S.D.Therapeutic audit of Dermatological prescription. Indian Journalof Dermatology 1995:40(1).12. Sarkar C, Das B, Sripathi H. Drug prescribing pattern inDermatology in a teaching hospital in western Nepal. Journal ofNepal Medical Association 2001:41:241-613. Nazima Y. Mirza, Sagun Desai and Barna Ganguly. Prescribingpattern in a pediatric out-patient department in Gujarat.Bangladesh J Pharmacology 2009; 4:39-42.14. Sarkar C, Das B, Sripathi H. Drug prescribing pattern inDermatology in a teaching hospital in western Nepal. Journal ofNepal Medical Association 2001:41:241-4615. Muhammad J, Chandar J. Pediatric dermatology: an audit atHamdard University Hospital, Karachi. Journal of PakistanAssociation of Dermatologists 2006; 16:93-616. Margaret R K, Therese A S, Virginia U. Reported Use ofPhotosensitizing Medications and Basal Cell and SquamousCell Carcinoma of the Skin. Journal of InvestigativeDermatology 2007; 127, 2901–2903; doi:10.1038/ sj.jid.5700934.17. Maria K, Sridhar KS, Pramod K, Gat R. Pattern of skin diseasesin Bantwal Taluq, Dakshina Kannada. Indian J DermatolVenereol Leprology 2000; 66:247-248.18. GS Rao, Kumar SS, Sandhya. Pattern of skin diseases in anIndian village. Indian Journal of medicinal science 2003;57:108-110.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 68

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaDevelopment and Validation of an Instrument to Assess the Perception of PharmacyStudents' on Medication Review ProcessRao JR*, Sravanthi LK, Singh TR and Rajan SDepartment of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, India – 576104A B S T R A C TSubmitted: 11/06/2012Accepted: 28/06/2012Background: Drug related problems can be best prevented by the safe and appropriate use of medicines. A structured medication reviewconducted by a clinical pharmacist will assist the patient in overcoming the medication related problems. Pharmacist led medication review is anascent activity in India, whereas in developed countries it has been in usual practice of the clinical pharmacist. Perception of the pharmacists hasan impact in achieving the better medication review outcomes. Use of proper tools to assess the perception of pharmacy students' on medicationreview will help to identify the level of understanding, expectations and barriers in conducting this process. The present study was aimed todevelop and validate an instrument (MeRPA) to assess medication review perception by the pharmacy students. A questionnaire with 13 itemshas been developed and the responses were collected from a sample of 209 pharmacy students using 5 point Likert Scale. The collectedresponses were statistically analyzed using SPSS 15.0. Reliability was assessed by calculating Chronbach's alpha and exploratory factoranalysis was performed to evaluate the construct validity. All items in the questionnaire were appreciably agreed by the respondents except oneitem (Item 13). No significant difference in perception scores based on age, sex and course. The mean score of PharmD IV year students wassignificantly higher than PharmD II and III year students. [One-way ANOVA, P

Rao JR - Development and Validation of an Instrument to Assess the Perception of Pharmacy Students' on Medication Review Processmedication review were accepted by the patients andimplemented by the general practitioners helping to improvequality and control of treatment without significant change in10,11drug costs. Studies revealed that pharmacy studentsthrough guided interview process were able to identify many12drug related issues.In the developed countries like Australia, United States andCanada medication review has been practiced as a part of13pharmaceutical care programs. In the past, Indian pharmacyeducation was relatively industry oriented with most of thecourses preparing students for an industry career. In therecent past Master level course in pharmacy practice wasstarted and a few years back Doctor of Pharmacy (PharmD)course was started. These recent courses are focused onpatient oriented practice including some course work on14, 15medication review.Poor motivation, lack of time, knowledge and self-confidencewere considered as barriers to conduct medication review.Similarly poor perception or lack of attitude was also found tobe a significant barrier. Attitude of the pharmacists has animportance in achieving success of the medication review16program. There is a need for valid and reliable instrument toassess the perception of medication review by the pharmacystudents in the Indian setting. The present study was aimed todevelop and validate an instrument to analyze the perceptionof medication review by the pharmacy students.METHODMedication Review Perception Assessment (MeRPA)Survey DevelopmentThe MeRPA instrument was developed at Department ofPharmacy Practice, Manipal University, Manipal, India withthe aim of assessing perception of medication review by thepharmacist. From the items generated through literaturereview, at about 30 items were screened after the brainstorming session. From the screened 30 items, through DelphiTechnique at about 13 items were considered satisfying thecriteria; Relevance, Appropriateness and Adequate. Likertscale (5 = Strongly Agree, 4 = Agree, 3 = Neutral, 2 =Disagree, 1 = Strongly Agree) is used to collect the itemresponses. Score ranges from 13-65.Participants and survey process or Study Population andSurvey administrationThe study was conducted at Manipal University. Survey wasconducted among students of PharmD, M.Pharmacy,B.Pharmacy (final year), who were taught with the clinicalpharmacy concepts in their curriculum. Responses to items ofthe instrument were collected using Likert scale. In addition,data regarding age, sex, course and year of study werecollected in this survey for instrument validation purpose.Statistical AnalysisThe collected data was analyzed through statistical Packagefor Social Sciences (SPSS 15.0, South Asia, Bangalore),(Descriptive and inferential statistical analysis).Demographics data were represented by frequencies andpercentages. Mean and standard deviation of total scores forall the respondents were also determined. Associationsbetween the demographic profile and responses wereexplored using Student's t-test and one-way ANOVA withpost-hoc test, Tukey's test. A two-tailed significance level of0.05 was considered as significant. The response statistics foreach item with median and inter quartile range were alsocalculated.Internal consistency of the responses to the items of MeRPAinstrument was determined by calculating the Cronbach'salpha. Reliability of the scale was assessed by calculating17Cronbach's alpha , inspecting partial alphas of each item, anddetermining the item to total correlations. Exploratory factoranalysis was performed to evaluate the construct validity andto determine the number of factors in the MeRPA instrument.Principal component method was used to extract the factors.Exploratory factor analysis extracted three factors. Afteridentifying the number of factors, the factors were subjectedto rotation using Varimax rotation with Kaiser Normalization.Items with factor loadings greater than or equal to 0.4 wereconsidered significant, and loadings of 0.5 or greater were[18]considered 'very significant' and the Factors were labeled.Results:The survey collected responses from a total of 209respondents from all the levels of pharmacy students.Respondents were equally distributed between males andfemale (50%) and majority of the respondents were in the agegroup of 21 – 25 (66.3%). Most of the respondents were fromPharmD (41.1%), followed by M.Pharmacy (26.3%). There isno significant association among sex, age, course and year ofthe study in perception of medication review. Scores basedon demographic variables (age, sex, and course) and theirsignificance on perception of medication review is presentedin Table 1.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 70

Rao JR - Development and Validation of an Instrument to Assess the Perception of Pharmacy Students' on Medication Review ProcessTable 1: Demographic details of students (n=209)Variables Number Percentage Mean Std. Deviation SignificanceSex:Male 107 52.5 54.94 5.867 0.773 (> 0.05)Female 97 47.5 55.44 4.991Total 204 100Age: 0.05)21-25 134 66.3 55.42 5.693>26 52.5 59.60 3.050Total 202 100Course:B.Pharmacy 39 18.7 53.77 7.165 0.163 (> 0.05)M.Pharmacy 55 26.3 54.76 4.485PharmD 86 41.1 55.34 6.316PharmD Post 29 13.9 56.93 4.636BaccalaureateTotal 209 100There is a significant difference in the mean scores based onthe year of education among particular level of education. Themean score of PharmD IV year students was significantlyhigher than PharmD II and III year students. There is nosignificant difference in perception between students ofM.Pharmacy, PharmD Post Baccalaureate (within the course)[One-way ANOVA, P

Rao JR - Development and Validation of an Instrument to Assess the Perception of Pharmacy Students' on Medication Review ProcessAll items in the MeRPA instrument were agreed by more than75% of the respondents except one item (Item 13), agreed atabout 45.5% only. “Medication Review is necessary to beconducted by all clinical pharmacists” and “MedicationReview is useful in improving communication with Patients aswell as health care professionals” were agreed by more than90% of the respondents. About 85% of the respondents agreedto “Medication review is a core requirement ofpharmaceutical care”. More than half of the respondentsdisagreed towards the item “Medication Review requires lotof Time and Effort to learn and practice” (54.5%). Responsesummary statistics with median and inter quartile range weredepicted in Table 3.As a part of reliability assessment, Cronbach's alphafor 13 item MeRPA instrument was found to be 0.815 basedon non-standardized items and 0.82 based on standardizeditems.Exploratory factor analysis gives three factors after extractionexplaining cumulative variance of about 50.5 %. Individualcontribution of the three factors was 32.45 %, 9.60 %, 8.46 %respectively. The items 4, 6, 7, 8, 9, 12 loaded under Benefitof MR (Factor 1); 10, 11, 13 loaded under Requirement ofMR (Factor 2); remaining items 1, 2, 3, 5 were loaded underProfessional Need of MR (Factor 3). Details of factorloadings and factors were given in Table 4.Table 3: Response statistics for individual items (n=209)Item Item Strongly Agree Neutral Disagree Strongly MedianNo. Agree Agree (Interquartilerange)1. Medication Review is necessary to be 132(63.16) 69(33.01) 6(2.87) 1(0.48) 1(0.48) 5(4-5)conducted by all clinical pharmacists2. Medication Review is professionally 76(36.36) 87(41.63) 36(17.22) 7(3.35) 3(1.44) 4(4-5)rewarding and valuable to one's career3. Medication Review is useful in improving 118(56.46) 72(34.45) 15(7.18) 4(1.91) 0(0.00) 5(4-5)communication with Patients as well ashealth care professionals4. Conducting Medication Review improves the 108(51.67) 79(37.80) 19(9.09) 3(1.44) 0(0.00) 5(4-5)intervening capability of pharmacist5. Medication Review is a core requirement of 96(45.93) 82(39.23) 23(11.00) 6(2.87) 2(0.96) 4(4-5)Pharmaceutical care6. Medication Review improves patient 102(48.80) 76(36.36) 26(12.44) 3(1.44) 2(0.96) 4(4-5)compliance and health status7. Medication Review ensures safe and cost 88(42.11) 83(39.71) 31(14.83) 6(2.87) 1(0.48) 4(4-5)effective therapy to the patient8. Medication Review optimizes 75(35.89) 82(39.23) 39(18.66) 10(4.78) 3(1.44) 4(3.5-5)polypharmacy prescriptions9. Medication Review ensures appropriateness 111(53.11) 71(33.97) 22(10.53) 1(0.48) 4(1.91) 5(4-5)of therapy through detection and preventionof drug related problems10. There is a need for Structured format to 105(50.24) 78(37.32) 22(10.53) 3(1.44) 1(0.48) 5(4-5)conduct Medication Review11. There is a need of specific training to conduct 2(44.02) 89(42.58) 23(11.00) 5(2.39) 0(0.00) 4(4-5)and document medication review12. Medication Review considers Medication 82(39.23) 89(42.58) 29(13.88) 6(2.87) 1(0.48) 4(4-5)History Interview (MHI) and Medicationreconciliation to ensure therapeutic individualization13. Medication Review requires lot of Time and 39(18.66) 77(36.84) 69(33.01) 19(9.09) 5(2.39) 4(3-4)Effort to learn and practiceIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 72

Rao JR - Development and Validation of an Instrument to Assess the Perception of Pharmacy Students' on Medication Review ProcessTable 4: Factor loading of the itemsS.NO Item No. Item Factors1 2 31. 4 Conducting Medication Review improves the intervening capability of 0.539pharmacist2. 6 Medication Review improves patient compliance and health status 0.6123. 7 Medication Review ensures safe and cost effective therapy to the patient 0.7454. 8 Medication Review optimizes polypharmacy prescriptions 0.6665. 9 Medication Review ensures appropriateness of therapy through detection 0.455and prevention of drug related problems6. 12 Medication Review considers Medication History Interview (MHI) and 0.454Medication reconciliation to ensure therapeutic individualization7. 10 There is a need for Structured format to conduct Medication Review 0.8118. 11 There is a need of specific training to conduct and document 0.814medication review9. 13 Medication Review requires lot of Time and Effort to learn and practice 0.43610. 1 Medication Review is necessary to be conducted by all clinical pharmacists 0.65311. 2 Medication Review is professionally rewarding and valuable to one's career0.53512. 3 Medication Review is useful in improving communication with Patients0.64as well as health care professionals13. 5 Medication Review is a core requirement of Pharmaceutical care 0.445Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization.(Factor loadings: > 0.4 significant and > 0.5 very significant)DISCUSSIONThe present study is an attempt to analyze perception ofmedication review by the pharmacists in India. An instrument(MeRPA) was developed to assess the medication reviewperception and the reliability and factor validity were tested.In a study conducted by MacIntosh et al a tool was developedto measure the pharmacist's attitudes and barriers ofproviding medication review. In this MacIntosh's study,Respondents agreed that Medication therapy management(MTM) services would be perceived valuable by patients,improves clinical outcomes. Survey results includespharmacists are more appropriate to provide MTM service[16]especially trained personnel. Respondents of the presentstudy also expressed positive opinion on medication reviewservice and considering it as necessary to be conducted byclinical pharmacists and useful in improving communicationwith patients and health care professionals.In a study conducted by Latif and Boardman with a developedquestionnaire to explore the attitude of communitypharmacists towards medication use review service theyfound that pharmacists felt, lack of time and non-availability19of support staff as barriers to medication review. Fewrespondents in the present study also felt the lack of time as aconstraint. According to respondents of Latif and Boardmanstudy respondents of the opinion, MURs were an opportunityfor pharmacist to improve the skill, practice the profession19and to provide better service to patients.Respondents had excellent understanding on medicationreview process. No significant association was foundbetween age, sex and level of education in perception ofmedication review. In this survey, the year of study had asignificant impact in perception of medication review.PharmD IV year students had significantly betterunderstanding on medication review process compared tofinal year B.Pharm, first year M.Pharm and second and thirdyears of PharmD courses. As these students were the firstbatch in India, their eagerness and readiness to be a member ofhealth care team, has led them to perceive the medicationreview at extreme levels.Chronbach alpha value 0.82 explains that the reliability of theresponses to the items was good. Three factors were emergedthrough factor analysis; named as Professional need of MR,Benefit of MR and Requirement of MR according to the itemsloaded under each factor.The developed instrument can be used to assess themedication review perception. The reliability and constructvalidity of the instrument were found, which givesinformation regarding impact of motivation and clinicalIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 73

Rao JR - Development and Validation of an Instrument to Assess the Perception of Pharmacy Students' on Medication Review Processcourses on individual students, training need of medicationreview. The information from this study will be used forchecking training needs.LimitationsMedication Review Perception Assessment Instrumentrequires cross validation. Survey should be conducted instudents and the working clinical pharmacists of variousregions to strengthen the validity of the MeRPA instrument.Convergent validity was not assessed for this instrument.CONCLUSIONThis study is the first of its kind in India to assess theperception of pharmacy students towards medication reviewusing a standard instrument. Respondents had enoughknowledge to understand the medication review processoutcomes. At about 96% of the respondents agreed to thenecessity of conducting medication review by all clinicalpharmacists. About 91 % of respondents felt that medicationreview is useful in improving communication skills ofpharmacist. These results shows that medication reviewprocess can become a part of all the practicing pharmacists'responsibilities provided they were given with adequatetraining and resources.ACKNOWLEDGEMENTSThe author wish to acknowledge all the respondents of thestudy and also, Manipal University, Manipal, India for havingprovided with the necessary support.References:1. Task force on medicines partnership and the nationalcollaborative medicines management services programme.Room for review: a guide to medication review: the agenda forpatients, practitioners and managers. London: MedicinesPartnership; 2002. http://www.npc.co.uk/med_partnership/assets/room_for_review.pdf.2. Hepler CD, Strand LM. Opportunities and Responsibilities inPharmaceutical Care. Am J Hosp Pharm 1990;47:533-43.3. Cipolle RJ, Strand LM, Morley PC. Pharmaceutical CarendPractice: The Clinician's Guide. 2 ed. New York, NY:McGraw-Hill; 2004: 119-170.4. Pharmaceutical Services Negotiating Committee. MURs: thebasics. What is the Medicines Use Review and PrescriptionIntervention Service? 2008. http://www.psnc.org.uk/pages/murs_the_basics.html .5. Clyne W, Blenkinsopp A, Seal R, Plus N. A Guide to MediccrtionReview 2008. rn. 2008;500:9.6. Lee E, Braund R, Tordoff J. Examining the first year ofMedicines Use Review services provided by pharmacists inNew Zealand: 2008. NZ Med J. 2009;122:3566.7. Lipton HL, Bero LA, Bird JA, McPhee SJ. The impact of clinicalpharmacists' consultations on physicians' geriatric drugprescribing: a randomized controlled trial. Medical Care.1992:646-58.8. Howard RL, Avery AJ. Pharmacist-led medication reviews canreduce patient morbidity? Age and Ageing. 2006;35(6):555.9. Niquille A, Lattmann C, Bugnon O. Medication reviews led bycommunity pharmacists in Switzerland: a qualitative survey toevaluate barriers and facilitators. Pharmacy Practice (Internet).2010:35-42.10. Zermansky AG, Petty DR, Raynor DK, Freemantle N, VailA,Lowe C. Clinical medication review by a pharmacist of elderlypatients on repeat prescriptions in general practice: arandomized controlled trial. BMJ 2001; 323: 1340-3.11. Zermansky AG, Alldred DP, Petty DR, Raynor DK, FreemantleN, Eastaugh J, et al. Clinical medication review by a pharmacistof elderly people living in care homes—randomised controlledtrial. Age and Ageing. 2006;35(6):586.12. Rovers J, Miller MJ, Koenigsfeld C, Haack S, Hegge K,McCleeary E. A Guided Interview Process to Improve StudentPharmacists' Identification of Drug Therapy Problems.American Journal of Pharmaceutical Education. 2011;75(1).13. Holland R, Smith R, Harvey I. Where now for pharmacist ledmedication review? Journal of epidemiology and communityhealth. 2006;60(2):92.14. Narayana T.V. Pharmacy education in India. Pharma Times.Mar 2011; Vol.43(3).15. Basak SC, Sathyanarayana D. Pharmacy education in India.Am J Pharm Educ. 2010;74(4):Article 68.16. MacIntosh C, Weiser C, Wassimi A, Reddick J, Scovis N, GuyM, et al. Attitudes toward and factors affecting implementationof medication therapy management services by communitypharmacists. Journal of the American Pharmacists Association.2009;49(1):26-3017. George, D., and Mallery, P. (2003). SPSS for Windows step bystep: A simple guide and reference. 11.0 update (4th ed.).Boston: Allyn and Bacon.18. Rencher AC. Methods of multivariate analysis: Wiley OnlineLibrary; 1995.19. Latif A, Boardman H. Community pharmacists' attitudestowards medicines use reviews and factors affecting thenumbers performed. Pharm World Sci. 2008;30(5):536-43.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 74

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaAssessment of Knowledge Perception and Attitudes on Medications in GeneralPopulationAishwaryalakshmi K*, Sasikala B, Sreelalitha N, Vigneshwaran E and Padmanabha YRDepartment of Pharmacy Practice, Raghavendra institute of pharmaceutical education and research, Anantapur, Andhra Pradesh, India.A B S T R A C TSubmitted: 04/05/2012Accepted: 24/06/2012Modern medicines have changed the way in which diseases are managed and controlled. Despite all their benefits, evidence continues to mountthat adverse reactions to medicines are common, yet often preventable, cause of illness, disability and even death. The objective of the presentstudy was to explore the perceptions and knowledge regarding ideas about the medication and as well as adherence in general population. Aquestionnaire was developed to assess both attitudes towards medications as well as self-medication. Our study found that the patients whoreceived family assistance in managing their medications often lacked an understanding of some of their own treatments. Most of therespondents have taken medications from the pharmacists only, which shows there is greater chance and opportunity for the pharmacists inguiding and providing proper education to the patients.INTRODUCTIONMedicine is considered as one of the most important necessityto all of us. Modern medicines have changed the way in whichdiseases are managed and controlled. Improper use ofmedicines brings potential health hazards. Despite all theirbenefits, evidence continues to mount that adverse reactionsto medicines are common, yet often preventable, cause ofillness, disability and even death. Hence, public knowledge,attitudes and practices regarding the use of medicinesinfluence the decision to seek health care, the use ofmedicines and ultimately the success of the treatment.Prescription of medicine is almost wide spread of medicalinterventions which always lie at the heart of clinical practice.Although there is an extensive literature on patients'adherence to medication, much less attention has been paid to1their ideas about medication. Knowledge Attitude Practice(KAP) Studies tells us what people know about certain things,2how they feel and also how they behave. Patient perceptionstowards medications might be important in a number of3ways. Patient education also plays a critical role infacilitating patients' acceptance of their diagnosis andunderstanding behavioral changes required for active4participation in treatment. Educational status is an importantdeterminant of self-medication. The problem of educatinglow-literate patients cannot be ignored. The JointAddress for Correspondence:K. Aishwaryalakshmi, Department of Pharmacy Practice, RaghavendraInstitute of Pharmaceutical Education and Research,Anantapur,AndhraPradesh, India.E-mail: vickku_e@yahoo.com.sgCommission on Accreditation of Health Care Organizationsmandated that hospitals and other health organizationsprovide instructions understandable to patients, assess4patients' knowledge, and document such educational effort.Patients with lower educational level might have more trust in5physicians' advice. Patient knowledge of drug therapy anddisease still remains poor and patient's memory ofinstructions given by physician is poor, since 50% of theinformation will be forgotten immediately. Lack ofcommunication and lack of patient uptake of information mayaccount for the marked up to 55% patient deviation from6prescribed drugs. The concept of self-medication whichencourages an individual to look after minor ailments with7simple and effective remedies has been adopted worldwide.Unsupervised self-medication places patients at risk formedication misuse. Patient self-medication may alsounwittingly generate dangerous drug–drug and drug–disease8interactions. This practice will be observed in societies with7high-level literacy. The objective of the present study was toexplore the perceptions and knowledge regarding ideas aboutthe medication and as well as adherence in generalpopulation.METHODOLOGYA questionnaire was developed after extensive literaturereview on the studies focusing on knowledge and perceptionstowards medications. We aimed to include statementsassessing both attitudes towards medications as well as selfmedication.The questionnaire was slightly modifiedaccording to the need of this particular population.Respondents were explained about the study and oral consentwas obtained from each and every participant. IndividualsIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 75

Aishwaryalakshmi K - Assessment of Knowledge Perception and Attitudes on Medications in General Populationwho did not give verbal informed consent or who were unableto answer the questions due to some barriers were excluded.The questionnaire covered the following aspects a) standarddemographic data to ascertain if there was any correlationbetween patient demographic characteristics and medicationmanagement practices; b) patient adherence and perception;c) self medication; d) information about medicines given tothem by pharmacists; e) obtaining prescriptions and havingthem filled.Table 1: Educational status of study populationIlliterates High school Graduates34% 43% 23%Fig. 1: Age wise distribution of population:RESULTSA total of 120 respondents were included in the study eventhough only 89 respondents were taken into consideration forthe assessment, due to incomplete response and therespondents were aged between 20-70 years. This studypopulation includes both the illiterates and literates, illiterateswere in more number than literates. The majority ofTable 3: Response Level of the Patients Based on the KAP QuestionnaireS.no Questions Related To Knowledge Perception And Attitudes About Medicines Response Level(percentage)1. What do you do when you have headache, temperature, cough and cold, body pains?I will go to pharmacy 69%I will consult doctor 31%2. Are you taking medicines at this moment?Yes 36%No 64%3 What type of medicines have you had in past?Minor illness 75%Major illness 25%4 Do you prefer drugs based on advertisements and do you ask the pharmacist for same drugs?Advertisements 15%Pharmacists 85%5 Do you think that all the OTC medicines are effective and safe?Yes 37%No 53%6 Have you ever experienced any side effects with medicines?Yes 33.7%No 66.3%7. Did you inform your pharmacist or physician about side effects of drugs you have experienced?Yes 30.3%No 69.7%8 Will you take nutritional supplements without asking your physician?Yes 12.6%No 88.3%Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 76

Aishwaryalakshmi K - Assessment of Knowledge Perception and Attitudes on Medications in General Population9 If you or your family members get same disease will you purchase same medicines or will you consult physician?Yes 34.9%No 64%10 When you got to doctor do you like to have prescription or are you looking fir something else?I will feel it enough information 41.6%I want some more information 58.3%11. Do you always get prescription filled as soon as you get them or do you wait for sometime?Immediately fill the prescription 61.7%I will wait for sometime 38.2%12 Have you ever had to take a medicine over a long period of time?Yes 31.4%No 68.5%13 Will you prefer to go to an alternative practitioner?Yes 57.3%No 42.7%14 Are you given enough information about your medicines when it is dispensed by pharmacists or prescribed byphysician?Yes 51.6%No 48.3%15 Do you think more costly drugs are more effective?Yes 59.5%No 40.4%16 While you consult a physician will you tell him/her about the medicines which you are usingpresently including OTC medications?Yes 61.7%No 38.2%17 Do you use the prescribed medications upto the given regimen or will you stop them if symptoms subside?Will use medicines until symptoms subside 53.9%Will use medicines up to given regimen 46%respondents are between the age group of 20-30 years group(47.1%), followed by 12.36%, 23.6%, 10.11% in age group of31-40 years, 41-50 years and 51-60 years respectively, whilethe least percentage of 6.7% of respondents were foundbetween the age group of 61-70 years.DISCUSSIONThe data presented in this paper describe the views of ageneral population about medications. The analysis has notbeen done according to the type of drug because sufficientlydetailed information about drug type was not collected. In ourresearch study, survey was carried out about medicationknowledge among different population in rural areas whichincludes both literates and illiterates.Many patients resort to the practice instead of contactinghealth care professionals because of long waiting periods inhospitals, minor ailments, cost to save money and time, lackof accessibility, shortage of doctors, or a feeling that theirailment is beyond the knowledge of well trained doctors.Without adequate knowledge of their medications intendedpurpose and effectiveness, patients relied on other factors,such as personal experience with their medications effects orcomplete trust in their provider's medical advice, to assign9importance ratings.Our study found that the patients who received familyassistance in managing their medications often lacked anunderstanding of some of their own treatments. Medicinesshould never be exchanged with others, friends or family asthey may not be appropriate to them. Patients should notbelieve in “a pill for every ill” and should accept nonmedicinestherapy when only advice and assurance is10provided by the physician.As in previous studies self-medication was considered as amajor problem associated with minor aliments like sore throatand common cold. With the option of obtaining antibioticsfrom pharmacies, it may be hard to limit direct access of11patients to antibiotics.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 77

Aishwaryalakshmi K - Assessment of Knowledge Perception and Attitudes on Medications in General PopulationThe adherence towards medication and the complete filling ofprescription was associated with the cost. Studies in lowincomecountries showed that the cost of medical consultationand low satisfaction with medical practitioners were also12related to self-medication.Patients should avoid practicing self-medication, if possible,but if unavoidable they should consult and seek help from thedispenser/pharmacist and not rely upon their own previousexperience. Previous surveys shown that literate people were1376% more likely to self-medicate than illiterate people.Pharmacists play a key role in providing information aboutOTC medications to the patient. Information technology willplay a fundamental part in helping pharmacists to providenew services. As mentioned in our study that most of therespondents have taken medications from the pharmacistsonly, which shows there is greater chance and opportunity forpharmacists to provide efficient professional guidance forsafe and appropriate OTC use. According to the literature,majority of the patients expressed positive attitudes towards14pharmacist provision of OTC medication and related advice.According to the results of our study, most of the physicians aswell as pharmacists were informed by patients regarding theside effects produced by the medication. So, the pharmacistshould provide information about side effects of drugs at thetime of dispensing and also about the completion ofprescribed regimen even after the symptoms has beensubsided.CONCLUSIONAs an outcome of our research, most patients were unawareabout the proper usage of medicines; Low level of knowledgemay put patients at risk of health related problems. Thisindicates the need for change in the perceptions and practicesof the health care professionals towards safe use of medicines.Community pharmacists should get continuous education andrepeated training programs because they are easily accessiblefor patients once the medicine is prescribed and Communitypharmacists can play a significant role in guiding andproviding proper education to the patients.REFERENCES1. Nicky Britten, Patients' ideas about medicines: a qualitativestudy in a general practice population, British Journal of GeneralPractice, 1994;44:465-8.2. Shah AP, Parmar SA, et al. knowledge, attitude and practice(kap) survey regarding the safe use of medicines in rural area ofGujarat, Advance Tropical Medicine and Public HealthInternational 2011; 1(2): 66 – 70.3. Benzanen Graeme Fincke, Donald R Miller, et al. The interactionof patient perception of over-medication with drug complianceand side effects. J GEN INTERN MED 1998; 13:182-1854. Mark V. Williams, David W. Baker, et al. Relationship ofFunctional Health Literacy to Patients' Knowledge of TheirChronic Disease, ARCH INTERN MED/VOL 158, 1998.5. Ruth Parker, Health literacy: A challenge for American patientsand their health care providers, Health promotionalinternational, 15(4).6. Emad Al-N, Najah Al- S, et al. Assessment of patient'sknowledge on their chronic medications, J. J. Appl. Sci., 2007;9,(1); 1-6.7. A. O. Afolabi, Factors influencing the pattern of self-medicationin an adult Nigerian population, Annals of African Medicine,2008; 7(3):120-278. Kerry Wilbur, Samah E.S, et al. Patient perceptions ofpharmacist roles in guiding self-medication of over-the-countertherapy in Qatar. Patient Preference and Adherence 2010:49. Denys T. Lau, Becky Briesacher, et al, Older Patients'Perceptions of Medication Importance and Worth: AnExploratory Study, Drugs Aging. 2008 ; 25(12): 1061–75.10. Abdo-Rabbo A, Al-Ansari M., Gunn BC, Jaffer B. PublicKnowledge, Attitudes and Practices towards Medicine Use inOman. Pharmaco Logical. 2007; 3: 1-12.11. Reeves DS. The 2005 Garrod Lecture: The changing access ofpatients to antibiotics—for better or worse? J AntimicrobChemother 2007; 59: 333–41.12. Saradamma RD, Higginbotham N, Nichter M. Social factorsinfluencing the acquisition of antibiotics without prescription inKerala State, south India. Soc Sci Med 2000; 50: 891–903.13. Dineshkumar B, Raghuram TC, et al. Profile of drug use in urbanand rural India. Pharmacoeconomics. 1995; 7(4):332-4614. Kerry Wilbur, Samah El, et al. Patient perceptions of pharmacistroles in guiding self-medication of over-the-counter therapy inQatar, Patient Preference and Adherence, 2010:4 87–93Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 78

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaA Possible Case of Filgrastim-Induced Death1 1 2 2 3Pawar V * , Krishna S.N , Narayana G. , Sadiq J and Thomas D1Pharm. D Intern, Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education & Research, Anantapur, AndhraPradesh2Assistant Professor, Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education & Research, Anantapur, AndhraPradesh3Head of Department of Pharmacy Practice, Raghavendra Institute of Pharmaceutical Education & Research, Anantapur, Andhra PradeshA B S T R A C TSubmitted: 21/07/2012Accepted: 31/07/2012This is a case report focusing on a 50 year old woman's death possibly due to Filgrastim. Filgrastim is considered to be a drug of choice inneutropenic cases. But in this case, Filgrastim has developed several severe Adverse Drug Reactions resulting into the death of patient.Naranjo's Causality Assessment Algorithm was used to assess the cause of death & the algorithm indicated Filgrastim as a possible cause ofdeath.Keywords: Filgrastim, Filgrastim-Induced Death, Drug-Induced Neutropenia & Granulocyte-Colony Stimulating FactorINTRODUCTIONCommercially available Granulocyte-Colony StimulatingFactor (G-CSF) preparations have significantly improved thequality of life (QoL) of patients with neutropenia1internationally. This report summarizes the development ofsore throat, breathlessness (dyspnoea), tachycardia &wheezing sound in chest associated with the use of Filgrastimwhich finally lead to patient's death.CASE REPORTA 50 year old woman was admitted in one of a private hospitalin Maharashtra, with following chief complaints;Ÿ Diffused scaly lesions over the exterior surface of rightforearm,Ÿ Similar kind of lesions over the sun-exposed areas of face& lips &Ÿ Black colored discoloration of skin.On local examination, the skin of patient was observed to bedry over the lesions with presence of extensive scaling &patient was unable to open her mouth freely due to presence ofsub-mucosal fibrosis (due to betel nuts chewing habit) overbuccal region. On the basis of this data, a preliminary/provisional diagnosis was done as exposure dermatitis & drugAddress for Correspondence:Vinay Gorakhnath Pawar, PharmD Intern ,B-2/112, Niligiri Building, AtmaramNagar, Lokgram Complex, Netivali Road, Kalyan (East), Dist. Thane – 421306.MaharashtraE-mail: vinaypharmd@gmail.comhypersensitivity. The past medical & medication history ofpatient was asthma since 18 years & unknown anti-asthmaticmedications. Patient was not having any past medical historyof cancer. Clinical laboratory tests (hematological tests) werecarried out, which revealed that there was a gradual decrease3in the neutrophil count (21.2%) & total count (500cells/mm )& increase in the Erythrocyte Sedimentation Rate (98mm/hr).A final diagnosis was then done as Drug-induced neutropeniaon the basis of these clinical laboratory values. Identificationof drug/s which induced neutropenia was not done. A 300 mcgprefilled syringe of Filgrastim was administeredsubcutaneously once daily, for 4 days to treat drug-inducedneutropenia. Other drugs like ceftriaxone, amikacin, liquidparaffin lotion, and chlorhexidine mouthwash were alsogiven to treat lesions & sub-mucosal fibrosis respectively.On very next day (day 2) of the treatment, patient startedcomplaining of having sore throat, throat pain & fever. On day3, she developed breathlessness (dyspnoea), tachycardia &drowsiness along with continuing sore throat & throat pain.On examining lungs, wheezing sounds from the chest wereheard. On day 4, patient's daughter reported patient'srestlessness which on observation was found to be severeseizure attacks with froth coming out of her mouth followedby cardiac arrest. On examination, she was found to beunconscious, her pulse was not palpating, pupils were notdilated & not reacting to light, no heartbeats & no breathingsounds were heard. Cardio-Pulmonary Resuscitation (CPR)was tried on the patient by starting chest compressions withambu-bag (at the rate of 30:2 breaths) to save her life. CPRwas given for around 20-25 minutes (6 times). Along withIndian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 79

Pawar V - A Possible Case of Filgrastim-Induced DeathCPR, Intravenous (IV) bolus injections of atropine – 1mg/ml(10 ampoules) & adrenaline – 1mg/ml (2 ampoules) were alsogiven. In spite of all the above resuscitation methodsaccording to Advanced Cardiac/Cardiovascular Life Support2, 3(ACLS) protocols, the patient couldn't survive & was beenmedically declared as dead.DISCUSSIONIn this case, drug-induced neutropenia was diagnosed &treated on the basis of clinical laboratory investigations otherthan Absolute Neutrophil Count (ANC) which is a main key4for diagnosing neutropenia. Furthermore the patient wastreated with Filgrastim without identifying the drug/s thatcaused neutropenia. Filgrastim is considered to be a drug of1, 5choice in neutropenic cases. But in this case, developmentof sore throat, breathlessness (dyspnoea), tachycardia &wheezing sound in chest may be triggered due to Filgrastim,as because sore throat is observed as an Adverse DrugReaction (ADR) or an undesirable effect in some of therandomized clinical trials conducted on Filgrastim & theother effects (dyspnoea, tachycardia & wheeze) are givenunder the “WARNING” column of Filgrastim as serious6-8allergic reactions. Secondly, as the patient had a pastmedical history of asthma, more care was to be taken inprescribing Filgrastim to the patient because of the possibilityof these systemic allergic-like reactions. In one of arandomized, open-labelled, multicenter study, patients withsevere allergic history (seasonal/recurrent asthma) wereexcluded (kept in exclusion criteria) from their study due to9these reasons. Taking all these information underconsideration, a causality assessment of death was done by10using Naranjo's Causality Assessment Algorithm & thealgorithm indicated Filgrastim as a possible cause of deathwith Naranjo score = 3.CONCLUSIONThis case report accentuates the importance of collectingcomplete data of patient's history such as; past medicalhistory, past medication history, current clinical laboratorytests, etc. before initiating any treatment. Also monitoring,reporting & management of ADRs are necessary in order toavoid such types of severe events.ACKNOWLEDGMENTWe would like to declare that there is no conflict of interest ofany of the authors of this article.REFERENCES1. Dale D.C., Bolyard A.A., Schwinzer B.G., et al., The SevereChronic Neutropenia International Registry: 10-year Follow-upReport. Supportive Cancer Therapy 2005;3(4):220-31.2. Neumar R.W., Otto C.W., Link M.S., et al., Adult AdvancedCardiovascular Life Support : 2010 American HeartCardiovascular Care Association Guidelines forCardiopulmonary Resuscitation and EmergencyCardiovascular Care. Circulation 2010; 122:S729-S767.3. Varon J., Fromm R.E. & Vallejo-Manzur F., Advanced CardiacLife Support Algorithms: Changes and Current American HeartAssociation Recommendations. Hospital Physician 2002;35-46.4. Provan D., Singer C.R.J., Baglin T. & Lilleyman J., OxfordndHandbook of Clinical Haematology, Oxford University Press. 2edition 2004;16,136.5. Hassan B.A.R., Yusoff Z.B.M. & Othman S.B., Filgrastim andantibiotics treatment reduces neutropenia severity in solidcancer patients. Asian Pacific J Cancer Prev. 2009;10:641-4.6. Clinical Pharmacology, Filgrastim, Available at:https://www.clinicalpharmacology.com//Forms/Monograph/monograph.aspx?cpnum=246&sec=monadve&h=647973706e6561 (Assessed on 16/07/2011).7. Package insert. Neupogen (Filgrastim). Thousand Oaks,California: Amgen Manufacturing, Limited, Inc., March 2010.8. Package insert. Nugraf (Filgrastim). Shameerpet, Hyderabad,Andhra Pradesh: Zenotech Laboratories Limited, VersionCF/01-06.9. Thierry F., Jean-Luc H., Frederic M., et al. Stem Cell Factor inCombination With Filgrastim After Chemotherapy ImprovesPeripheral Blood Progenitor Cell Yield and Reduces ApheresisRequirements in Multiple Myeloma Patients: A Randomized,Controlled Trial. Blood 1999;94(4):1218-1225.10. Naranjo C.A., Busto U., Seliers E.M., et al., (1981), A Method forEstimating the Probability of Adverse Drug Reactions, Clin.Pharmacol. Ther. 1981;30(2):239-245.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 80

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References, figures, and legends shall followthe general guidelines described below. For all other Articles, thefollowing format shall be strictly followed.Title Page. The following information should appear: title of article (Arunning title or short title of not more than 50 characters), authors'name, and last name. The author to whom all correspondence beaddressed should be denoted by an asterisk mark. Full mailingaddress with pin-code numbers, phone and fax numbers, andfunctional e-mail address should be provided of the author forcorrespondence. Names of the authors should appear as initialsfollowed by surnames for men and one given-name followed bysurname for women. Full names may be given in some instances toavoid confusion. Names should not be prefixed or suffixed by titles ordegrees.Abstract: The abstract is limited to 250 words, and should describethe essential aspects of the investigation. In the first sentence, thebackground for the work should be stated; in the second sentencethe specific purpose or hypothesis shall be provided; followedsequentially by summary of methods, results and conclusion. Noreferences should be cited.Indian Journal of Pharmacy Practice Volume 5 Issue 2 Apr - Jun, 2012 81

Instructions to AuthorsIntroduction: A brief background information on what has beendone in the past in this area and the importance of the proposedinvestigation shall be given. Introduction shall end with a statementof the purpose or hypothesis of the study.Material and Methods: This section may be divided into subsectionsif it facilitates better reading of the paper. The researchdesign, subjects, material used, and statistical methods should beincluded. Results and discussion shall not be drawn into this section.In human experimentation, ethical guidelines shall beacknowledged.Results: This section may be divided into subsections if it facilitatesbetter reading of the paper. All results based on methods must beincluded. Tables, graphic material and figures shall be included asthey facilitate understanding of the results.Discussion: Shall start with limited background information andthen proceed with the discussion of the results of the investigation inlight of what has been published in the past, the limitations of thestudy, and potential directions for future research. The figures andgraphs shall be cited at appropriate places.Conclusion: Here, the major findings of the study and theirusefulness shall be summarized. This paragraph should address thehypothesis or purpose stated earlier in the paper.Acknowledgments. Acknowledgments should appear on aseparate page.Tables. Each table should be given on a separate page. Each tableshould have a short, descriptive title and numbered in the order citedin the text. Abbreviations should be defined as footnotes in italics atthe bottom of each table. Tables should not duplicate data givenin the text or figures. Only MS word table format should be used forpreparing tables. Tables should show lines separating columns withthose separating rows. Units of measurement should be abbreviatedand placed below the column headings. Column headings orcaptions should not be in bold face. It is essential that all tables havelegends, which explain the contents of the table. Tables should notbe very large that they run more than one A4 sized page. If thetables are wide which may not fit in portrait form of A4 size paper,then, it can be prepared in the landscape form. Authors will be askedto revise tables not conforming to this standard before the reviewprocess is initiated. Tables should be numbered as Table No.1Title…., Table No.2 Title…. Etc. Tables inserted in word documentshould be in tight wrapping style with alignment as center.Figures, Photographs and Images: Graphs and bar graphsshould preferably be prepared using Microsoft Excel and submittedas Excel graph pasted in Word. These graphs and illustrationsshould be drawn to approximately twice the printed size to obtainsatisfactory reproduction.Specification of Legends/values in Graphs Font Arial, size- 10pt, Italics- None] Diagrams made with Indian ink on whitedrawing paper, cellophane sheet or tracing paper with handwritten captions or titles will not be accepted. Photographsshould be submitted only on photo-glossy paper. Photographsshould bear the names of the authors and the title of the paper on theback, lightly in pencil. Alternatively photographs can also besubmitted as 'jpeg/TIFF with the resolution of 600 dpi or more'images. Figure and Table titles and legends should be typed on aseparate page with numerals corresponding to the illustrations.Keys to symbols, abbreviations, arrows, numbers or letters used inthe illustrations should not be written on the illustration itself butshould be clearly explained in the legend. The complete sets oforiginal figures must be submitted. Legends should be in the presenttense (e.g., 'Illustration shows ...'). Subjects' names must not appearon the figures. Labels should contrast well with the background.Images should be uniform in size and magnification. Illustrationsshould be free of all identifying information relative to the subject andinstitution. Written permission for use of all previously publishedillustrations must be included with submission, and the sourceshould be referenced in the legends. Written permission from anyperson recognizable in a photo is required. Legends must be doublespaced, and figures are numbered in the order cited in the text. Colorprints shall be submitted only if color is essential in understandingthe material presented. Label all pertinent findings. The quality of theprinted figure directly reflects the quality of the submitted figure.Figures not conforming to acceptable standards will be returned forrevision. Figures should be numbered as Fig.1, Fig.2 etc. ; Figuresinserted in word document should be in square wrapping style withhorizontal alignment as center.Resolution: Drawings made with Adobe Illustrator and CorelDraw(IBM/DOS) generally give good results. Drawings made inWordPerfect or Word generally have too low a resolution; only ifmade at a much higher resolution (1016 dpi) can they be used. Filesof scanned line drawings are acceptable if done at a minimum of1016 dpi. For scanned halftone figures a resolution of 300 dpi issufficient. Scanned figures cannot be enlarged, but only reduced.Figures/Images should be submitted as photographic qualityscanned prints, and if possible attach an electronic version (TIFF/JPEG).Chemical terminology - The chemical nomenclature used must bein accordance with that used in the chemical abstracts.Symbols and abbreviations - Unless specified otherwise, alltemperatures are understood to be in degrees centigrade and neednot be followed by the letter 'C'. Abbreviations should be those wellIndian Journal of Pharmacy Practice Volume 5 Issue 2 Apr - Jun, 2012 82

Instructions to Authorsknown in scientific literature. In vitro, in vivo, in situ, ex vivo, adlibitum, et al. and so on are two words each and should be written initalics. None of the above is a hyphenated word. All foreign language(other than English) names and words shall be in italics as a generalrule.General Guidelines for units and symbols - The use of theInternational System of Units (SI) is recommended. For meter (m),gram (g), kilogram (kg), second (s), minute (m), hour (h), mole (mol),liter (l), milliliter (ml), microliter (µl). No pluralization of symbols isfollowed. There shall be one character spacing between number andsymbol. A zero has to be used before a decimal. Decimal numbersshall be used instead of fractions.Biological nomenclature - Names of plants, animals and bacteriashould be in italics.Enzyme nomenclature - The trivial names recommended by theIUPAC-IUB Commission should be used. When the enzyme is themain subject of a paper, its code number and systematic nameshould be stated at its first citation in the paper.Spelling - These should be as in the Concise Oxford Dictionary ofCurrent English.PAGE LAYOUT GUIDELINES Indian Journal of Pharmacy PracticePage size Letter Portrait 8.5” X 11.0”Margins All Margins, 1”Page numbersIndentFooter / HeadersTitleTextTablesNumbered as per the assigned page /Absolutely no breakor Missed sectionsNone, Absolutely, No TabNone14pt Times New Roman, bold, centered followed by asingle blank line.12pt Times New Roman, full justification1.5 line spacingbetween paragraph. No indentationAt the end of context with rows and columns active; tablesshould have individual rows and columns for each valueexpressed. All text should be fully justified.Please put all primary section titles in UPPER CASE letters(Example INTRODUCTION, MATERIALS AND METHODS,R E S U LT S , D I S C U S S I O N , A C K N O W- L E D G E M E N T,REFERENCES) and subheading in both Upper and Lower Caseletters (Italics). Do not number your subtitles (for example, 1.0Introduction; 2.0 Background; 2.1.1 are not acceptable). Do not usethe tab key to indent blocks of text such as paragraphs of quotes orlists because the page layout program overrides your left marginwith its own, and the tabs end up in mid-sentence.ReferencesLiterature citations in the text must be indicated by Arabic numeralsin superscript. Each reference separately in the order it appears inthe text. The references should be cited at the end of the manuscriptin the order of their appearance in the text. In case of formalacceptance of any article for publication, such articles can be cited inthe reference as “in press”, listing all author's involved. Referencesshould strictly adhere to Vancouver style of citing references.Format: Author(s) of article (surname initials). Title of article. Journaltitle abbreviated Year of publication; volume number (issuenumber):page numbers. Standard journal article (If more than sixauthors, the first three shall be listed followed by et al.) You CH, LeeKY, Chey WY, Menguy R. Electrogastrographic study of patients withunexplained nausea, bloating and vomiting. Gastroenterology1980;79:311-4.Books and other monographsFormat:Author(s) of book (surname initials). Title of book. Edition.Place of publication: Publisher; Year of publication.Personal author(s)Eisen HN. Immunology: an introduction to molecular and cellularprinciples of the immune response. 5th ed. New York: Harper andRow; 1974.Editor, compiler, as authorDausser J, Colombani J, editors. Histocompatibility testing 1972.Copenhagen: Munksgaard; 1973.Organisation as author and publisherInstitute of Medicine (US). Looking at the future of the Medicaidprogram. Washington: The Institute; 1992.Conference proceedingsKimura J, Shibasaki H, editors. Recent advances in clinicalneurophysiology. Proceedings of the 10th International Congress ofEMG and Clinical Neurophysiology; 1995 Oct 15-19; Kyoto, Japan.Amsterdam: Elsevier; 1996.DissertationKaplan SJ. Post-hospital home health care: the elderly's access andutilization [dissertation]. St. Louis (MO): Washington Univ.; 1995.PatentLarsen CE, Trip R, Johnson CR, inventors; Novoste Corporation,assignee. Methods for procedures related to the electrophysiologyof the heart. US patent 5529 067. 1995 Jun 25.Chapter or article in a bookFormat: Author(s) of chapter (surname initials). Title of chapter. In:Editor(s) name, editors. Title of book. Place of publication: Publisher;Year of publication. page numbers.Indian Journal of Pharmacy Practice Volume 5 Issue 2 Apr - Jun, 2012 83

Instructions to AuthorsElectronic journal articleMorse SS. Factors in the emergence of infectious diseases. EmergInfec Dis [serial online] 1995Jan-Mar [cited 1996 Jun 5];1(1):[24screens]. Available from: URL: http://www.cdc.gov/ncidod/EID/eid.htmWorld Wide WebFormat: Author/editor (surname initials). Title [online]. Year [citedyear month day]. Available from: URL:World Wide Web page McCook A. Pre-diabetic Condition Linked toMemory Loss [online]. 2003 [cited 2003 Feb 7]. Available from: URL:h t t p : / / w w w . n l m . n i h . g o v /medlineplus/news/fullstory_11531.htmlAbbreviations for Journals For More information on medlineindexed journals : Download list of medline journals:ftp://ftp.ncbi.nih.gov/pubmed/J_Medline.zipAmerican Journal of Pharmacy- (Amer J Pharm)Analytical Chemistry- (Anal Chem)British Journal of Pharmacology and Chemotherapy- (Brit JPharmacol)Canadian Journal of Pharmaceutical Sciences- (Can J Pharm Sci)Clinical Pharmacokinetics- (Clin Pharmacokinet)Drug Development and Industrial Pharmacy- (Drug Develop IndPharm)Helvitica Chimica Acta- (Helv Chim Acta)Indian Journal of Medical Sciences- (Indian J Med Sci)Indian Journal of Pharmaceutical Sciences- (Indian J Pharm Sci)Journal of the American Chemical Society, The- (J Amer ChemSoc)Journal of Biological Chemistry- (J Biol Chem)Journal of Organic Chemistry, The- (J Org Chem)Journal of Pharmacology and Experimental Therapeutics- (JPharmacol Exp Ther)New England Journal of Medicine- (N Engl J Med)Pharmaceutical Journal, The (Pharm J)PharmacologicalResearch Communications- (Pharmacol ResCommun)AUTHOR's CHECKLIST FOR SENDING PROOFS TOEDITORIAL OFFICEIn order to maintain quality and consistency in Indian Journal ofPharmacy Practice, we ask you to perform the following items priorto submitting your final proof for publication:· Include the original, hard copy of Author's Transfer ofCopyright signed by each author· Thoroughly check the article for typographic errors, formaterrors, grammatical errors, in particular: spelling of names,affiliations, any symbols, equations in the context, etc.· Provide graphs and figures in excel format, Pictures arerequired as high resolution images (300 dpi).· Provide laser printed hard copies of all figures and graphics inblack and white or scanned copies can also be sent toijopp@rediffmail.com· Submit a proof corrected with RED INK ONLY.· List out the corrections made in typed format in a separate pagewith the proof.Send the Corrected Proof, Copyright Transfer Form, with covering letter in a single envelope to the Following AddressAuthors are required to send their contributions or manuscripts through post or courier services.Dr. Shobha Rani R HiremathEditor, Indian Journal of Pharmacy Practice (ijopp).C/o. Association of Pharmaceutical Teachers of India (APTI),H.Q: Al-Ameen College of Pharmacy,Opp. Lalbagh Main gate, Hosur Road, Bangalore 560 027, Karnataka, INDIA.All enquiries can be made through e-mail: ijopp@rediffmail.comIndian Journal of Pharmacy Practice Volume 5 Issue 2 Apr - Jun, 2012 84