Oct-Dec, 2011 - Indian Journal of Pharmacy Practice

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaScenario of Pharmacovigilance and ADR Reporting among Pharmacists in DelhiAmrita P*, Roomi M.TDelhi Institute of Pharmaceutical Sciences and Research,Pushp Vihar sector III, M.B. Road, New Delhi, 110017A B S T R A C TSubmitted: 18/10/2011Accepted: 9/11/2011Adverse drug reactions enhance suffering of patients and increase morbidity and mortality. The aim of our study was to evaluate the awarenessof pharmacists working in Delhi regarding pharmacovigilance, adverse drug reaction (ADR) and it's reporting. A questionnaire containing 27questions was prepared and distributed to 230 pharmacists. Response rate of this survey was 64.35%. Out of these, 31.76% were hospitalpharmacists, 26.35% were community pharmacists and 41.89% were medical representatives. Only 40.54% of pharmacists were found toknow the broad meaning of pharmacovigilance. The correct meaning of the term 'adverse drug reaction' was known to 27.70% pharmacists.Majority of pharmacists (77.03%) did not report the ADRs noticed by them. Only 4.05% pharmacists had tentative information that reporting canbe done at national monitoring center and/or regional monitoring centers. Further, only 3.38% pharmacists knew All India Institute of MedicalSciences/Lady Hardinge Medical College as the ADR monitoring centers of Delhi. Out of these, only 0.68% Pharmacists had the phone numberand/or address of these centers. It indicates that the ADR reporting is done by pharmacists at places other than official monitoring centers.Pharmacists reported ADRs to physicians, manufacturing industry, product management team and chief pharmacist. Pharmacists in Delhi havepoor basic knowledge of pharmacovigilance, ADR and its reporting. Pharmacist's participation in ADR reporting is negligibly low. Education andtraining of pharmacists is essential to improve the ADR reporting. Pharmacist's active participation along with other healthcare providers wouldincrease the ADR reporting rate. Pharmacovigilance should be included in the pharmacy curriculum.Keywords: Adverse drug reaction, ADR reporting, Pharmacovigilance, Pharmacist.INTRODUCTIONIn 1960, use of Thalidomide for prevention of morningsickness by pregnant women gave excellent results but thedisaster struck when phocomelic babies were born. Thisforced the healthcare professionals to become aware aboutthe adverse drug reactions, its implications on patient safetyand cost of treatment. Adverse drug reaction is a response to amedicine which is noxious and unintended and which occursat a dose used in humans for prophylaxis, diagnosis, therapy1or modification of physiological functions. ADRs add to thesuffering of patients and increase morbidity and mortalitybesides being a financial burden on society. It has beenestimated that ADRs cause up to 7% of all hospitaladmissions in the UK and 13% of all admissions to internal2medicine clinics in Sweden. In New Zealand, 12.9% of all3hospital admissions are due to adverse drug events. Fataladverse drug reactions rank among the most common causes4of death in the United States. ADRs have been estimated toAddress for Correspondence:Amrita Parle, Delhi Institute of Pharmaceutical Sciences and Research,PushpVihar sector III, M.B. Road, New Delhi, 110017E-mail: amrita.parle@gmail.com,account for up to 1,06,000 deaths annually in the United4,5States. The study of Bord et al indicated that, in patients whoexperience ADRs, death rates were 19.18% higher and the6length of hospital stay is 8.25% higher.India has become a destination for conducting clinical trials.During clinical trials, medicines are generally studied in acontrolled environment, for a relatively small number ofpatients, and usually for a limited duration. These trialssometimes exclude the elderly, the very young, and patientswith co-morbidities. Often patients on multiple drug therapyand patients with decreased renal and hepatic function areexcluded. For these patient populations, any vulnerability toADRs may be missed. Adverse reactions may occur at such alow frequency that they are not being detected in the smallnumbers of patients included in clinical trials. Furthermore, itis extremely difficult to predict how practitioners willactually use medications in practice. Once the drug iscommercially available, the exclusion criteria applied inclinical trials, no longer exist. Thus, exposure to the drug maylast longer, as therapy may continue long term, increasing thepossibility of previously undetected problems to arise and beidentified. Additionally, widespread use of medicines in thegeneral population can increase the chances for uncoveringIndian Journal of Pharmacy Practice Volume 4 Issue 4 Oct - Dec, 2011 29