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

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

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

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