Extent of pharmacovigilance among resident doctors in Edo and Lagos states of Nigeria

Abstract

Systematic attention to adverse drug reactions (ADRs) started with the thalidomide disaster in the early 60s of the 20(th) century. In 1968 ten countries supported a spontaneous reporting system for ADR and collaborated with the WHO pilot research project for international drug monitoring. This survey was conducted to determine the level of awareness of resident doctors about ADRs reporting, the extent of their involvement in pharmacovigilance activities and to build a useful data base that will improve the quality of health care in Nigeria. This cross-sectional observational survey was conducted in University of Benin Teaching Hospital (UBTH) and Irrua Specialist Teaching Hospital (ISTH), Lagos University Teaching Hospital (LUTH) and Lagos State University Teaching Hospital (LASUTH) in Edo and Lagos states, Nigeria, respectively. STUDY DESIGN / METHODS: A cross-sectional observational survey was used in this study. Total population under survey being 971 residents with the sample size of 350 statistically determined. The survey conducted revealed that 78.1% (258) of the respondents had inadequate knowledge about pharmacovigilance with 71.2% (235) unaware of the yellow forms for ADR reporting distributed by the National Agency for Food and Drug Administration and Control (NAFDAC). The respondents (92.4%) have observed ADRs in the course of their training and practice, yet only 25.5% of cases were reported. The reported cases (7.3%) were to the National Agency for Food and Drug Administration and Control. The study showed a statistically significant difference between the institution of respondents, knowledge and experience about pharmacovigilance (p < 0.05). There is marked under-reporting of cases and a low level of awareness about pharmacovigilance among resident doctors in Edo and Lagos states. This may be what obtains in other states in Nigeria.