W.A. Adedeji1, W.A. Ibraheem2 and F.A. Fehintola1,3
- Department of Clinical Pharmacology, University College Hospital, Ibadan.
- Department of Ophthalmology, Ladoke Akintola University Teaching Hospital, Ogbomoso.
- Department of Pharmacology and Therapeutics, College of Medicine, University of Ibadan.
Background: Adverse drug reactions, (ADRs), constitute an important cause of morbidity and mortality worldwide. Spontaneous adverse drug reaction (ADR) reporting is the bedrock of post-marketing surveillance but under-reporting remains its major drawback.
Objectives: This study aimed at evaluating the attitude and practice of ADR among doctors in a tertiary health facility in Oyo State, Nigeria, with a view to improving ADRs reporting.
Methods: This was a cross-sectional questionnaire based study involving medical doctors working at the Ladoke Akintola University of Technology (LAUTECH) Teaching Hospital, Ogbomoso. Consenting doctors were evaluated on their attitude and practice of ADRs through self-administered questionnaire. Data obtained were entered and analyzed using SPSS version 17.
Results : A total of 35 doctors responded to the questionnaires. Only about 57.1% considered ADR before prescribing, all of whom were also aware of the procedure for reporting. Awareness of the existence of National Pharmacovigilance Center (NPC) was 71.4%. Thirty (85.7%) of the respondents have encountered ADR, but only 2.9% have ever reported it with yellow form. Majority (85.7%) of the respondents did not consider ADR reporting as a useful tool in the prevention of drug related morbidities and mortalities. Other factors that may hinder ADR reporting include: lack of awareness of the existence of yellow forms for reporting (68.6%) and poor knowledge of procedure for reporting (48.6%).
Conclusion: ADR reporting rate was very low among the participants in this small study; large studies aimed at evaluating the determinants of ADR reporting should be considered. Should these findings be confirmed, training and re-retraining through Continuing Medical Education (CME), and establishment of pharmacovigilance committee would be required to ensure a national pharmaovigilance system.
Keywords: Adverse drug reactions, Attitude, Practice, Reporting, Clinical Pharmacology
Prof. F. A. Fehintola
Dept. of Clinical Pharmacology,
University College Hospital,
Tel: +234 8055202959
Adverse Drug Reactions (ADRs) constitute an important cause of morbidity and mortality affecting all age groups. An ADR is any noxious, unintended and undesired effect of a drug, which occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy of disease or the modification of physiological functions.1 It is known that ADR may occur with any drug even when used correctly.2 However, certain factors may predispose or contribute to development of ADR and these may include: irrational use of drugs and poor prescribing patterns; promotional activities by pharmaceutical company; inadequate access to objective sources of information; liberal drug outlets and unhealthy pharmaceutical practices; self-medication practices; “drug gifts” from overseas; lack of public awareness and low literacy level .3
The burden of ADRs is borne by all populations and throughout the world is expected to be higher in developing countries because of ignorance, poverty, self-medication and increase prevalence of fake and adulterated medicines.4 The economic burden of ADRs on the society is enormous, for example, in the US, an estimated annual cost of drug-related problems is 30 billion Dollars.5
Consequent upon the thalidomide disaster, drugs are only approved for the use of humans after they have been properly evaluated and found to be safe. This pre-marketing evaluation of drugs has some major drawbacks: there is under-estimation as adverse drug reactions with incidence of less than 1% are frequently not identified; there is selection bias imposed by the standard protocols of clinical trials; and there is incomplete or lack of information on chronic toxicity.6,7 Post-marketing surveillance is a very important tool for ensuring safety of drugs and complements the clinical drug evaluation done before approval. It is instructive that when drugs are administered to all populations the probability of adverse and other drug related problems will manifest more easily than during the clinical evaluation stages. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions or any other drug related problem.7
The role of medical doctors is vital in recording and reporting suspected ADRs in order that regulatory agencies are alerted of emerging safety concerns and thereby facilitating timely and appropriate action. Evaluating the attitude and practice of doctors may assist in developing strategies to improve ADRs reporting.
The study was conducted at LAUTECH Teaching Hospital, Ogbomoso, Nigeria. The hospital provides medical services to communities in Oyo and the neighbouring Kwara and Osun States. Presently, the hospital does not have a consultant grade Clinical Pharmacologist and pharmacovigilance committee.
Design and data collection
This was a cross-sectional study involving doctors who were surveyed with a questionnaire. The self administered questionnaire sought details of biosocial information of the consenting doctors and the elements of attitude and practice of ADRs.
Data obtained were entered into SPSS version 17 software for analysis. The results were presented as mean standard deviation for quantitative variable and numbers with percentages for categorical variables. Tests of association between categorical variables were determined with the Fisher’s exact test and continuous variables with student’s t-test. A p-value of less than 0.05 was considered statistically significant.