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

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

Amrita P - Scenario <strong>of</strong> Pharmacovigilance and ADR Reporting among Pharmacists in DelhiFig. 3: Intra-pr<strong>of</strong>ession correlation regardingPharmacovigilance skillsJ- Inform patients about therapeutic effects, K- Inform patientsabout side effects, L- Do patient inform you about side effects,M- Do you report ADR, N- Have set procedure <strong>of</strong> reporting ADRin their organization, O- Have ADR reporting form.interaction between hospital pharmacists and patients wasfound to be best among the three. This is indicated from theresponse that, 57.44 % <strong>of</strong> hospital pharmacists, 46.15% <strong>of</strong>community pharmacists and 33.87% <strong>of</strong> medicalrepresentatives were informed by the patients/physicianabout the side effects experienced by patients. Involvement <strong>of</strong>hospital pharmacists (44.68%) in reporting ADR was greaterthan the medical representatives (14.51%) and communitypharmacists (10.25%). The study <strong>of</strong> van Grootheest AC et al,reported that contribution <strong>of</strong> hospital pharmacists to ADR22reporting in Canada and United States is by far the largest. Incontrary the study <strong>of</strong> Su C et al showed that hospitalpharmacists in a northern region <strong>of</strong> China had a reasonableknowledge <strong>of</strong> and positive attitudes towardspharmacovigilance, however the majority <strong>of</strong> pharmacists had23never reported an ADR in their career.In our study involvement <strong>of</strong> community pharmacists in ADRreporting is lowest. This may be due to sub-optimal level <strong>of</strong>knowledge about the drugs, lack <strong>of</strong> confidence and inaptpr<strong>of</strong>essional approach. Our community pharmacists restrictthemselves to mere dispensing <strong>of</strong> marketed preparations.Contrary to our observation, van Grootheest AC et al reportedthat in Netherlands, community pharmacists play asignificant role in ADR reporting. They contributesubstantially, both in numbers and in quality <strong>of</strong> ADR reports.In Netherlands the contribution <strong>of</strong> community pharmacists to24pr<strong>of</strong>essional ADR reports is 40.02%. In Japan and Spain39% and 25.9% pr<strong>of</strong>essional ADR reports originate from22community pharmacists.Hospital pharmacists (19.14%) and medical representatives(16.12%) reported that they have set channel for reportingADR, while 97.44% <strong>of</strong> community pharmacists said they donot have any channel for reporting ADR. Establishing achannel for reporting ADR and informing about the same tothe practicing pharmacists, would promote the reporting bypharmacists. Though 44.68% <strong>of</strong> hospital pharmacists,14.51% <strong>of</strong> medical representatives and 10.25% <strong>of</strong>community pharmacists reported observed ADRs, only2.56% <strong>of</strong> community pharmacists, 2.12% <strong>of</strong> hospitalpharmacists and 3.22% <strong>of</strong> medical representatives had ADRreporting form. From this data, it is once again very clear thathospital pharmacists, community pharmacists and medicalrepresentatives report the ADR verbally to chief pharmacist,physician, purchasing department <strong>of</strong> hospital, manufacturingindustry, department in-charge, product management teamand not to the NMC, RMC or peripheral monitoring center.This kind <strong>of</strong> reporting is not <strong>of</strong> much help in ensuring patientsafety.In a Malaysian study, community pharmacists claimed tohave some knowledge <strong>of</strong> a reporting system but the actualreporting was insignificant. Further all <strong>of</strong> them agreed that it25was part <strong>of</strong> their pr<strong>of</strong>essional obligation to report an ADR.Survey by Toklu Hz et al shows that Turkish communitypharmacists have poor knowledge about pharmacovigilance16with just 7% ADR reporting by them.Attitude <strong>of</strong> pharmacists:One hundred sixteen (78.38%) pharmacists felt that the ADRmonitoring is essential. Four (2.70%) pharmacists felt ADRmonitoring is not essential while 28 (18.92%) pharmacistsdid not respond. It may be possible that these pharmacists didnot understand the meaning <strong>of</strong> ADR monitoring. The study<strong>of</strong> Granas AG et al conducted in Norway also shows that26pharmacists had positive attitudes towards ADR monitoringwhile study <strong>of</strong> Vessal G et al conducted in Iran shows thatmore than half <strong>of</strong> the responding pharmacists felt that ADRreporting should be voluntary, while 26% felt it to be a18pr<strong>of</strong>essional obligationNineteen (12.84%) pharmacists felt that there is no need toreport the ADR as it is well known. But as per the CDSCOGuidelines even the minor ADRs should be reported as it may27throw light on prescribing patterns. Ninety five (64.19%)pharmacists felt that pharmacists are not trained enough fordetecting and reporting ADR. Out <strong>of</strong> 148 participatingpharmacists only 56 (37.84%) pharmacists said they undergocontinuing education program. One hundred eleven (75%)pharmacists were <strong>of</strong> the opinion that education and training inpharmacovigilance would play a pivotal role in improvingADR reporting. The study <strong>of</strong> Sweis et al and Green et alconducted in UK and study <strong>of</strong> I. Ribeiro Vaz et al in Portugal<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> 34

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