Abstract
BackgroundSpontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance. ADR reporting with Yellow Cards has tremendously improved pharmacovigilance of drugs in many developed countries and its use is advocated by the World Health Organization (WHO). This study was aimed at investigating the knowledge and attitude of doctors in a teaching hospital in Lagos, Nigeria on spontaneous ADR reporting and to suggest possible ways of improving this method of reporting.MethodsA total of 120 doctors working at the Lagos State University Teaching Hospital (LASUTH), in Nigeria were evaluated with a questionnaire for their knowledge and attitudes to ADR reporting. The questionnaire sought the demographics of the doctors, their knowledge and attitudes to ADR reporting, the factors that they perceived may influence ADR reporting, and their levels of education and training on ADR reporting. Provision was also made for suggestions on the possible ways to improve ADR reporting.ResultsThe response rate was 82.5%. A majority of the respondents (89, 89.9%) considered doctors as the most qualified health professionals to report ADRs. Forty (40.4%) of the respondents knew about the existence of National Pharmacovigilance Centre (NPC) in Nigeria. Thirty-two (32.3%) respondents were aware of the Yellow Card reporting scheme but only two had ever reported ADRs to the NPC. About half (48.5%) of the respondents felt that all serious ADRs could be identified after drug marketing. There was a significant difference between the proportion of respondents who felt that ADR reporting should be either compulsory or voluntary (χ2 = 38.9, P < 0.001). ADR reporting was encouraged if the reaction was serious (77, 77.8%) and unusual (70, 70.7%). Education and training was the most recognised means of improving ADR reporting.ConclusionThe knowledge of ADRs and how to report them are inadequate among doctors working in a teaching hospital in Lagos, Nigeria. More awareness should be created on the Yellow Card reporting scheme. Continuous medical education, training and integration of ADR reporting into the clinical activities of the doctors would likely improve reporting.
Highlights
Spontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance
This study has shown inadequate knowledge of doctors about ADRs and reporting similar to the previous reports among resident doctors in Nigeria [17] and doctors in many countries across Europe [18,22,23,24], America [25,26] and Asia [27,28]
Spontaneous ADR reporting by other health professionals and individuals is practiced in many countries [29,30,31] and it is recommended by the National Pharmacovigilance Centre (NPC) [32] but not recognised by the respondents
Summary
Spontaneous adverse drug reaction (ADR) reporting is the cornerstone of pharmacovigilance. The contribution of health professionals, in this regard, to ADRs databases is enormously significant and has encouraged ongoing ascertainment of the benefit-risk ratio of some drugs [7,8] as well as contributed to signal detection of unsuspected and unusual ADRs previously undetected during the initial evaluation of a drug [9,10]. In spite of these benefits, under-reporting remains a major draw-back of spontaneous reporting [10,11]. This high rate of under-reporting can delay signal detection and impart negatively on the public health
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