Evaluation of the pharmacovigilance system in the Dr Kenneth Kaunda District in the North West Province

Abstract

The use of drugs is not without the risk of possible adverse drug reactions (ADRs). Information about ADRs is limited due to the short time frame and limited population groups in clinical trials. Pharmacovigilance is the only system that monitors the safety of any drugs on the market. The pharmacovigilance system depends on healthcare professionals to report ADRs on an ADR report form. The information from the ADR reports is used to expand the limited drug safety information. The under-reporting of ADRs by healthcare professionals and the lack of quality ADR reports have been identified as barriers in the pharmacovigilance system. To determine the standard of the pharmacovigilance system in the Dr Kenneth Kaunda District (DKKD), this study evaluated pharmacovigilance practice in the DKKD in the North West Province. This cross-sectional study was conducted in two steps. The healthcare professionals’ awareness, experience and perception of pharmacovigilance and factors that contribute to the success of pharmacovigilance in the Tlokwe Local Municipality were determined in Step 1. Step 2 evaluated the completeness of the content of the completed ADR forms available in the DKKD and compared these forms with the minimum requirements for an ADR report form according to the World Health Organization (WHO). In Step 1 a structured questionnaire was provided to medical practitioners (n=52), pharmacists (n=15), and professionals nurses (n=53) in the Tlokwe Local Municipality. The questionnaire was developed according to the WHO and South African ADR reporting guidelines and a literature review of similar studies. The response rate for Step 1 was 40.8% (n=49). In Step 2, two checklists were designed to evaluate the completeness of the contents of 1 454 Medicines Control Council (MCC) ADR and 92 antiretroviral (ART) ADR report forms. The checklists for the MCC and the ART ADR report forms were based on the different sections that have to be completed on the respective ADR report forms. The majority of healthcare professionals indicated a good awareness of what should be reported, what to do when an ADR occurs, and who is responsible for reporting ADRs. The awareness concerning the reporting of well-known ADRs and ADRs caused by a medication error can be strengthened. The majority of healthcare professionals (64.6%) had reported an ADR in the past, but the training history to identify and report ADRs varied between the healthcare professional groups. Healthcare professionals do not receive feedback from the national pharmacovigilance centre (77.1%) and no reimbursements are provided when an ADR is reported (71.4%). These were identified as professional factors that discourage ADR reporting among healthcare professionals, in addition to the time it takes to complete the ADR report (56.3%) and the increased workload (54.2%). The majority of healthcare professionals agreed that pharmacovigilance can be improved if ADR reporting is mandatory (95.5%). The completeness of all sections on the MCC and ART ADR report forms was low. Sections about ADR outcomes were completed at 57.9% for the MCC and only 13.0% for the ART ADR report forms. The most incomplete section on the MCC ADR report form was the section that describes the ADR (0.1%). This same section was fully completed on 46.7% of ART ADR report forms. The most incomplete section on the ART ADR report form was patient information (1.1%). Product quality problems were reported on 17 MCC ADR report forms, but not one report was fully completed. The study determined that the awareness of and attitude towards reporting ADRs among healthcare professionals was good, but the completeness of the ADR report forms was poor. Recommendations for possible improvement of identified problems in Step 1 and Step 2 were made, including recommendations for future studies.