Knowledge, Attitude and Perception of Pharmacy Professionals Towards ADR Reporting - A Pharmacoepidemiological Study

1Rakesh Kumar Rishi, 2Rakesh K. Patel & 3Anil Bhandari

Abstract: Knowledge, attitude and perception of pharmacy professionals towards ADR reporting was assessed by self administered, anonymous questionnaire containing closed ended questions. A total of 249 pharmacy professionals (mainly students) responded to the questionnaire. Majority of the respondents (81.52%) disagree that drugs available in the market are safe and 85.94% said that pharmacists should report ADRs. When asked whether training for ADR reporting to the pharmacists is needed, 90.36% agreed to that. The opinion regarding legal liability was divided among the respondents. A total of 69.07% said that ADR reporting is a time consuming activity with no outcome. Majority of the respondents (87.55%) said that ADR reporting by pharmacist would be useful in providing better patient care. Half of the study population was aware of the pharmacovigilance programme in India. A total of 16.8%, 14%, and 4.8% respondents said that ADR reporting should be done to doctor/hospital, to drug manufacturers, and to the Government authorities respectively. Only 2.8% said that reporting should be done to the head of the institution. Majority of the respondents (48.19%) said that ADRs should be reported to all of the above authorities. When asked in the questionnaire about what to report, 11.24% of the respondents said that only mild ADRs which cause less inconvenience should be reported. A total of 12.45% said that serious and life threatening ADRs should be reported. While 6.24% of the study population said that severe ADRs that cause disability should be reported, majority of the respondents (63.45%) were in the favour of reporting ADRs in all of the above cases. Present study concludes that pharmacy profession in India is supportive to ADR reporting and if given the opportunity, seeks its active role in pharmacovigilance.

Introduction: Adverse drug reactions are known to be a major cause of morbidity and mortality all over the world. However, only a small proportion of ADRs are reported which does not give a clear picture of the overall safety of the medicinal product. It is a well known fact that ADR reporting is fundamental to the safety surveillance of the marketed medicinal products. The spontaneous reporting of adverse drug reactions (ADRs) is an important method for detecting new safety issues related to drugs. Pharmacovigilance is defined by the World Health Organization (WHO) as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem". An adverse drug reaction (ADR) has been defined as any noxious, unintended and undesired effect of a drug which occurs at a dose used in humans for prophylaxis, diagnosis, therapy or modification of physiological functions (WHO). Pharmacovigilance not only help early detection of ADRs, but also facilitate in identifying both risk factors and the mechanism underlying the ADR. The pharmacovigilance also benefit the drug regulatory agencies as they take precautions against future risks of medicinal products that can potentially lead to large costs to the society 1,2.



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