Knowledge, Attitudes, and Perceptions of Pharmacovigilance Among Pharmacists in Pharmaceutical Companies in South Africa

Abstract

Background: The South African Health Regulatory Authority (SAHPRA) is responsible for monitoring the safety of all medicinal products approved in South Africa (SA). Although it is not legislated for Healthcare Professionals (HCPs) to report adverse drug reactions (ADRs) in SA; however, underreporting of ADRs amongst HCPs remains a concern in SA and understanding the reasons why this is so will provide an understanding on how to resolve this concern. Therefore, the aim of the research was to identify the knowledge, attitudes, and perceptions of pharmacovigilance (PV) among pharmacists in pharmaceutical companies in SA. Methodology: This qualitative, questionnaire-based study was conducted online using the RedCap tool. The sample size was 162 respondents. Approval from Ethics was received from the University of the Witwatersrand Human Research Ethics Committee (Non-Medical). Data analysis was conducted using Satisfy t-test online calculator. Results: A total of 85 responses were received, which was a 52.5% response rate. 59 (69.4%) respondents were females and 30 (35.4%) were between 25 and 34 years. 33 (38.8%) respondents have held a position in regulatory affairs and 24 (28.2%) have worked in pharmaceutical organisation for a period between 1 and 5 years. 59 (69.4%) respondents hold a Bachelor of Pharmacy (B.Pharm) completed at local universities (62, 72.9%). 53 (62.4%) respondents received in-house training on management of ADRs and 13 (15.3%) respondents had no additional PV training. The overall knowledge mean score achieved was (85, 72.8%) despite a low correct response on the timelines for reporting suspected ADRs (30, 94.1%) and the Periodic safety update reports (PSUR) / Periodic Benefit Risk Evaluation Report (PBRER) knowledge (37, 43.5%). 84 (98,8%) respondents agreed that reporting of ADRs is an important activity to ensure safety of medicines and 46 (54.2%) believed that educational background has provided them with enough information about ADR reporting. 51 (60.0%) respondents agree that there is adequate PV awareness, however; education through PV conferences was suggested to improve management of ADRs in SA (51, 60.0%). Only 33 (38.8%) respondents have completed an ADR form, and 20 (23.5%) respondents have submitted an ADR report to SAHPRA. Conclusions: The study highlights the need for more training and awareness on ADRs and PV. While the knowledge of the respondents was fair, this did not translate to ADR reporting amongst this sector. Pharmacists’ attitude and perceptions towards the significance of pharmacovigilance in drug development and safety was encouraging.