Evaluation of Knowledge, Awareness, and Practice of Pharmacovigilance Among Practicing Doctors

Abstract

Objective: The primary objective of the study was to assess the awareness, knowledge, and practice of pharmacovigilance (PV) among the practicing doctors. The secondary objective was to ascertain the reason for underreporting of adverse drug reactions (ADRs) in India. Methods:A cross-sectional study was conducted using a pretested and validated questionnaire. The questionnaire was designed to assess these parameters of PV. These questionnaires were distributed among 90 doctors to ascertain the answers. In addition, the same parameters were reassessed (post-questionnaires) after sensitizing the doctors about PV. Results:Only 52 doctors took the posttest, a response rate of 57%. The mean awareness, knowledge, and practice of PV among doctors were 4.70, 3.60, and 2.90, respectively, which significantly increased in post-test questionnaire (p<0.05). The Pearson correlations revealed that the level of awareness among the respondents was significantly related to the knowledge and the practice of PV, linearly, and positively. In other words, higher the awareness more was the knowledge and better was the methods of application. The most common factor discouraging doctors from reporting ADRs was they found it difficult to decide whether ADR has occurred or not (32.69%). Conclusion:There was a significant positive correlation between awareness, knowledge, and practice of PV. In spite of these findings, the ADR reporting rate is negligible in India. To bring about a strong culture of reporting among doctors, it is mandatory to continuously expose doctors to the concepts of PV by continuous medical education, workshops, seminars and to make reporting mandatory in India.

Knowledge, attitude, practices, and barriers regarding pharmacovigilance and adverse drug reaction reporting among medical and dental faculties of the teaching hospitals in Bhubaneswar City

“…Within the last decade, there has been a growing awareness that the scope of pharmacovigilance should be extended beyond the strict confines of detecting new signals of safety concerns. [ 2 11 ] The present study was conducted with the objective of evaluating the KAP regarding pharmacovigilance and the barriers preventing ADR reporting among medical and dental professionals.…”

Current Status of Materiovigilance Globally-an Utter Overview With Clinical Case Perusal

“…To improve the protection of health safety of the patients, users and others by reducing the frequency of an incident [2,3].…”

“…Adverse event reporting system helps in reporting the adverse events associated with the medical device. It is considered as an important tool through which all types of adverse events related to the medical device can be reported [3,6,16]. Reporting the adverse event will lead to the protection and improvement of health and safety of the patients or users.…”

“…The following enforcement actions have been incorporated by TGA, to ensure the supply of only safe, effective and quality medical devices in the market and for the maintenance of the vigilance program [6,38] in exercise of all the power after consultation in accordance with section 11 enabling him in that behalf, of Consumer Protection Act 1987, with the organization that appears to be representative of interest which are markedly affected by these Regulations and other persons which he considers appropriate and with the Health and Safety Commission [3].…”

“…The term "vigilance" means close monitoring of the possible adverse effects [1][2][3][4]. Materiovigilance is the study of adverse events associated with the use of medical devices.…”