Background: Spontaneous reporting is the most efficient and cost effective method of monitoring the safety of registered drugs. The programme was launched in Ghana in June 2001. The spontaneous adverse drug reaction system is affected by underreporting by doctors and other healthcare professionals; there is however, limited knowledge about the factors that contribute to low reporting of adverse drug reactions and the reporting rate in Ghana.
Objective: The general objective of this study is to review the spontaneous adverse drug reaction reporting system in the Greater Accra region of Ghana. Methods: The study was a cross sectional survey of 259 doctors involved in clinical practice in 23 hospitals classified as government 199 (76.8%), quasi-governmental 43(16.6%) and private 17 (6.6%) hospitals in the Greater Accra Region of Ghana. The questionnaire was self-administered by the doctors. The 23 hospitals in which the questionnaires were distributed were selected at random and the doctors within the hospitals by convenient sampling. All analysis was done using STATA Version 10 and histograms constructed with MS Excel, 2007.
Findings: The response rate in this study was 86.3%. Of the 259 doctors who completed the questionnaire, 154 (59.5%) had seen a patient with suspected adverse drug reaction in the past one year but only 31 (21%) of them had reported it by completing the spontaneous adverse drug reaction reporting form. The reasons given by the doctors for not reporting were unavailability of the reporting form (43.1%) and lack of knowledge of the reporting procedures (28.5%). One hundred and twenty-one (46.9%) of the doctors had excellent knowledge and 32 (12.4%) had good knowledge of the reporting system. Place of work, rank of the doctor, training and knowledge of the reporting system were significantly associated with adverse drug reaction reporting. Doctors working in government hospitals were about 5 times more likely to report than those in private hospitals [OR=4.94, 95%CI (1.55-15.69)] and medical officers about twice likely to report than other ranks [OR=1.77, 95%CI (0.93-3.40)].
Conclusion and Recommendation: Despite the fact that about 47% of the doctors had excellent knowledge of the reporting system, this was not translated into adverse drug reaction reporting. To improve reporting, the reporting forms should be made readily available to the doctors in their consulting rooms and patient wards, training and refresher courses should be organized, and each report submitted by a doctor should be acknowledged and prompt feedback given on the actions taken.