Spontaneous Reporting of Adverse Drug Reaction Among Health Professionals In Kpone-Katamanso District, Ghana

Abstract Background: Spontaneous reporting of adverse drug reactions (ADR) is an effective means of ensuring postmarketing surveillance of drugs, and health professionals play a cardinal role through voluntary reporting of ADR. However, the pharmacovigilance system in Ghana is plagued with under-reporting issues, which is of public health concern. Method: A questionnaire-based cross-sectional study involving 268 health professionals at Kpone-Katamanso District was carried out. Data on spontaneous reporting of ADR, demographics of participants, knowledge, and attitudes of professionals towards reporting and factors that may influence ADR reporting were collected. Logistic regression models were used to examine the association of the independent variables with spontaneous reporting of ADR.Result: Overall, 77.6% (208) of the 268 respondents had witnessed ADR; however, only 17.3% of the respondents have ever reported an ADR to the FDA. Health professionals who had adequate knowledge on spontaneous reporting of ADR were 51.9%, while 30.3% had very good knowledge of spontaneous reporting of ADR. After statistical adjustment, Age (AOR=2.26, 95%CI= 1.25–4.10), Fear of Legal Consequences (AOR=0.15, 95%CI=0.41–0.51), Time Constraint (AOR=0.3, 95%CI=0.10–0.91), Pharmacovigilance training (AOR= 18.78, 95%CI= 5.46–64.59) and Unavailability of Reporting form (AOR=0.28, 95%CI=0.09– 0.88) were found to be significantly associated spontaneous reporting of ADR. Conclusion: The proportion of health professionals in the Kpone-Katamanso District who spontaneously report observed ADR is low. Our findings underscore the need for the FDA to intensify awareness through media sensitization and engage all relevant stakeholders on the need for the entire population to report ADR.