Pharmacovigilance: How aware are the prescribers?

ABSTRACT

Background: Adverse drug reactions (ADRs) is one of the important factors contributing to morbidity and mortality among patients and is a major public health burden. Spontaneous ADR reporting plays an important role in detection of ADRs, reducing their incidence and improving patient safety. India has one of the lowest ADR reporting rates in the world. Aim and Objective: The aim of the study was to assess the knowledge, attitude and practice (KAP) of doctors towards pharmacovigilance. Materials and Methods: A KAP questionnaire validated by subject experts was given to the doctors outside the teaching profession within 50 km of Government TD Medical College, Alappuzha, who consented to be a part of the study. The questions were structured to obtain the demographic details of the doctors, their KAP toward pharmacovigilance. No identifiable information regarding the participants was collected and the participants were assured of their confidentiality. A week’s time was given to the participants to answer the questions. Results: During the period of 1 year from June 2019 to May 2020, a total of 121 doctors responded to the questionnaire. The respondents aged from 26 to 67 years with the mean age being 37.31 ± 14.15 years. 94 (77.7%) thought that anyone could report an ADR while 16 (13.2%) thought that only doctors could report ADRs. Only 76 (62.8%) were aware of the existence of National Pharmacovigilance Centre in India. Ninety-eight (81%) did not know how to submit the ADR form to the nearest pharmacovigilance center. A vast majority 99 (81.8%) thought that ADRs to drugs of any system of medicine could be reported, while 20(16.5%) felt that only ADRs to modern medicines need to be reported. Among the factors discouraging doctors from reporting ADRs, lack of training to report an ADR 99 (81.8%) and lack of time during practice 83 (68.5%) were cited as the common reasons. A vast majority 116 (95.9%) had not received any formal training on ADR reporting and 114 (94.2%) opined that they would like to receive a formal training on the same. Conclusion: Doctors were largely aware of pharmacovigilance but had lack of KAP of reporting ADRs and filling up an ADR form. It emphasizes the need for regular mandatory education and training on ADR reporting among healthcare workers, and also the need to run continuous awareness campaigns on spontaneous reporting of ADRs to enhance reporting rate.