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

ABSTRACT

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.

KEYWORDS:

• Pharmacovigilance
• adverse drug reactions
• health care professionals
• hospitals
• training
• South Africa

Acknowledgments

All the healthcare professionals who participated in the study are gratefully acknowledged.

Authors’ contributions

AT, JCM and RSS developed the concept and designed the study. AT and BBG conducted the literature review. AT collected and analysed the data, which was supervised by JCM and RSS. All authors interpreted the data and AT drafted the manuscript. All authors participated in the critical review of subsequent versions of the manuscript and contributed significantly to its contents and to the management of the manuscript.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This study was not funded.