Impact of a pharmacist-driven pharmacovigilance system in a secondary hospital in the Gauteng Province of South Africa.

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.

Knowledge, attitudes and perspective on adverse drug reaction reporting in a public sector hospital in South Africa: baseline analysis.

OBJECTIVE: Adverse drug reactions (ADRs) can cause significant harm in patients; however, ADRs are under-reported in many countries, including South Africa, where evidence of a pharmacovigilance (PV) system to monitor and manage ADRs is a requirement for compliance with norms and standards for quality healthcare delivery. We conducted an analysis amongst health care professionals (HCPs) at Sebokeng Hospital to assess the situation there and make recommendations. METHODS: Data were collected using a structured self-administered questionnaire, targeting all medical practitioners, nurses, pharmacists and pharmacist assistants in the hospital. Current procedures for reporting of ADRs were documented. Records were reviewed to determine the number of ADR reports submitted for the 18-month period prior to the study. Data were analysed with SAS. Ethical clearance was obtained. RESULTS: The questionnaire was completed by 132 HCPs (nurses: 58.3%; medical practitioners: 23.5%; pharmacist assistants: 11.4%; pharmacists: 6.8%). The vast majority indicated ADR reporting is necessary (96.2%) and their professional obligation (89.4%). Only 18.9% were aware of an existing PV system in the hospital, 15.2% had an ADR form available and 18.9% knew to whom the form should be submitted. The vast majority had never reported an ADR, had never received training in PV, but wanted training on ADR reporting. Factors discouraging ADR reporting included not knowing how to report them (53.8%), lack of time (37.1%), additional work load (22.0%), uncertainty about the outcome of reporting (32.6%), and lack of confidence to discuss ADRs with colleagues (22.0%). Only 2.3% knew how many ADRs were reported, that ADRs are discussed by a committee (6.1%) and that internal feedback is received on reported ADRs (6.1%). CONCLUSION: There is an extensive need in Sebokeng Hospital for training on ADR reporting and implementation of systems to facilitate relevant processes; a need which may also exist in other public hospitals in South Africa.