Abstract and Background
Background: Spontaneous 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.
Methods: A 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.
Results: The 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.
Conclusion: The 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.
Adverse drug reactions (ADRs) are global problems of major concern. They affect both children and adults with varying magnitudes, causing both morbidity and mortality.[1–4] In addition to the human costs, ADRs have a major impact on public health by imposing a considerable economic burden on the society and the already-stretched health-care systems.[5,6] Post marketing surveillance of drugs is very important in analysing and managing the risks associated with drugs once they are available for the use of the general population. Spontaneous reporting has contributed significantly to successful 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] It is estimated that only 6–10% of all ADRs are reported.[12,13] This high rate of under-reporting can delay signal detection and consequently impart negatively on the public health.
Many factors are associated with ADRs under-reporting among health professionals. These factors have been broadly classified as personal and professional characteristics of health carers, and their knowledge and attitudes to reporting. Inman has summarized these factors as the 'seven deadly sins'. His description of the 'sins' include: attitudes relating to professional activities (financial incentives: rewards for reporting; legal aspects: fear of litigation or enquiry into prescribing costs; and ambition to compile or publish a personal case series) and problems associated with ADR-related knowledge and attitudes (complacency: the belief that very serious ADRs are well documented by the time a drug is marketed; diffidence: the belief that reporting an ADR would only be done if there was certainty that it was related to the use of a particular drug; indifference: the belief that the single case an individual doctor might observe could not contribute to medical knowledge; and ignorance: the believe that it is only necessary to report serious or unexpected ADRs), and excuses made by professionals (lethargy: the procrastination and disinterestedness in reporting or lack of time to find a report card and other excuses). Lopez-Gonzalez et al, in their review of determinants of ADRs under-reporting from the global perspective, have shown that three of the seven 'sins' proposed by Inman that are associated with professional activity (financial incentives, fear and ambition to publish) seem to contribute less significantly to under-reporting. Insecurity (the belief that it is nearly impossible to determine whether or not a medicine is responsible for a particular ADR) is another factor associated with under-reporting but was not proposed by Inman. It therefore appears that factors that promote under-reporting may vary from one country to another.
The determinants of ADRs under-reporting have not been extensively studied in Africa. Only two studies have analysed these factors in African countries.[15,16] A previous study from Nigeria has indicated inadequate knowledge of resident doctors about ADRs. However, the study excluded other cadres of doctors, it did not evaluate attitudes that were associated with under-reporting and did not assess the in-depth knowledge of the doctors about ADRs reporting.
This study was therefore aimed at investigating the knowledge and attitudes of doctors to ADR reporting in a teaching hospital in Lagos, Nigeria and to suggest possible ways of improving spontaneous reporting based on our findings.
BMC Clin Pharmacol. 2009;9:15 © 2009
Cite this: Perceptions of Doctors to Adverse Drug Reaction Reporting in a Teaching Hospital in Lagos, Nigeria - Medscape - Aug 11, 2009.