Oct-Dec, 2011 - Indian Journal of Pharmacy Practice

Oct-Dec, 2011 - Indian Journal of Pharmacy Practice Oct-Dec, 2011 - Indian Journal of Pharmacy Practice

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

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

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

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