BACKGROUND AND AIMS: Under-reporting of adverse drug reactions (ADRs) by health-care professionals (HCPs) is a worldwide problem. Spontaneous reporting in hospitals is scarce and several obstacles have been identified for this. Improved hospital-based reports could make important contributions to future care. Consequently, the objective of this study was to develop, implement and evaluate a structured pharmacist-driven pharmacovigilance (PV) system for in-patient ADR reporting in a leading public hospital in South Africa for future use in South Africa and wider.
METHOD: Descriptive, operational intervention study with a pre-post design. Pharmacist-driven interventions targeted at ADR reporting were implemented. Convenience sampling was used to recruit HCPs [medical practitioners, pharmacists, pharmacist assistants, and nurses] to complete a self-administered questionnaire. The principal outcome measures were the number of the ADRs reported for inpatients, 18 months prior to and 18 months during the intervention period, as well as an evaluation of the intervention program in terms of continuous information and training.
RESULTS: There was a significant increase in the number of HCPs reporting an ADR post-intervention (33.8% up from 12.1%; p < 0.0001). Reasons for non-reporting decreased significantly, e.g. 'How, where and when to report' an ADR (p = 0.0027) and 'Concern that the report may be wrong' (p = 0.0041). HCPs' knowledge of the ADR reporting system also improved appreciably. This was apart from pharmacists who were already knowledgeable.
CONCLUSION: The results showed the benefits of pharmacist-driven interventions on HCPs' knowledge and awareness of PV and the number of the ADRs reported. Hospital management and policy makers should consider the important role pharmacists can play in improving rational and safe use of medicines among inpatients, based on appropriate training of HCPs and proper systems. As a result, help achieve the standards established by the Department of Health in South Africa.
- South Africa
- adverse drug reaction reporting
- medicine management
- patient safety