Abstract
BackgroundSpontaneous 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.MethodA 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.ResultOverall, 77.6% (208) of the 268 respondents had observed ADR; however, only 17.3% of the respondents had ever reported an ADR to the Ghana FDA. Health professionals who had average knowledge on spontaneous reporting of ADR were 51.9%, while 30.3% had good knowledge of spontaneous reporting of ADR. After adjustment on potential confounding variables (Knowledge, Feedback from FDA, Uncertainty about cause of ADR, Severity of ADR), 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.ConclusionThe proportion of health professionals in the Kpone- Katamanso District who spontaneously reported observed ADR was low though they had average knowledge about ADR reporting. This underscores the need for a policy to be implemented that makes spontaneous reporting of adverse drug reaction mandatory for health professionals.
Highlights
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
The proportion of health professionals in the Kpone- Katamanso District who spontaneously reported observed ADR was low though they had average knowledge about ADR reporting
This underscores the need for a policy to be implemented that makes spontaneous reporting of adverse drug reaction mandatory for health professionals
Summary
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. When administered within their therapeutic dosing schedule, drugs can lead to unwanted effects, which may pose threats to the life of patients [1]. These unwanted effects are referred to as adverse drug reactions (ADR) - undesirable effects that may occur as part of a drug’s pharmacological action [2]. In order to reduce the incidence of ADR, the safety of drugs are ascertained through various phases of clinical trials prior to their approval on the market [6].
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