Department of Medicine

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Browsing Department of Medicine by Subject "ADR reporting"

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    A cross-sectional study to investigate the knowledge, attitudes, and current practices of pharmacovigilance, among medical doctors and pharmacists in South Africa
    (Stellenbosch : Stellenbosch University, 2021-12) Rikhotso, Nyeleti Portia; Page, Carine; Reuter, Helmuth; Stellenbosch University. Faculty of Medicine and Health Sciences. Dept. of Medicine: Clinical Pharmacology.
    Background: Pharmacovigilance pertains to activities aimed at monitoring medicines for related safety concerns, thereby ensuring patient safety and wellbeing. The primary method of pharmacovigilance is spontaneous reporting of adverse drug reactions (ADRs). ADRs have a socio-economic impact when they are not reported and mitigated appropriately. This impact is even more apparent in low-to-middle income countries (LMICs), an economic category encompassing all African countries. The World Health Organisation (WHO) has developed a global pharmacovigilance database (Vigibase®) for countries which are members of the Programme for International Drug Monitoring (PIDM), which includes many African countries. ADR reporting levels however remains low across Africa. This is also true for South Africa, despite being the first African country to become a member of the PIDM in 1992. Therefore, this research study was conducted to investigate the knowledge, attitudes, and practices of pharmacovigilance among medical doctors and pharmacists in South Africa. The aim of this study is to investigate the factors influencing the low adverse drug reporting levels by healthcare professionals in South Africa. Methodology: A cross-sectional survey was conducted in the form of a knowledge, attitudes, and practices (KAP) study design. The targeted sample population was 384 study participants. The questionnaire consisted of closed-ended questions, designed to assess the demographics, knowledge, attitudes, practices of healthcare professionals nationally. The survey also served to obtain suggestions from healthcare professionals to improve ADR reporting in SA. An online survey was created in the survey platform, SurveyMonkey® and the e-link to the survey was shared with the South African Medical Association (SAMA) and the South African Clinical Research Association (SACRA), two professional associations hosting memberships of registered medical doctors and pharmacists in South Africa. Both associations distributed the e-link to their members via email. The obtained data was analysed using IBM SPSS® Statistics version 27. Results: A total of 325 responses were received, accounting for 85% of the target sample population. Most (252; 77.5%) of the study participants on this study received an average score for their knowledge on pharmacovigilance, despite extremely low reported levels (91;28%) of training. Most of the respondents (269; 82.8%,) thought that awareness regarding pharmacovigilance in their professional environment is inadequate. Although the majority (310; 95.4%) of respondents agreed that ADR reporting is their professional obligation, (119; 36.6%) had never seen a reporting form and only (172; 52.9%) had ever participated in ADR reporting. The major factors discouraging respondents from participating in ADR reporting were lack of knowledge on the reporting process and lack of access to the ADR reporting form. The topmost suggestions selected by the respondents to improve ADR reporting in South Africa were to include pharmacovigilance training in the undergraduate curricula of South African universities (266; 81.8%) as well as implementation of on-line or telephonic reporting platforms (235; 72.3%). Conclusion: This study indicates that there is an average level of knowledge of pharmacovigilance amongst medical doctors and pharmacists in South Africa and that they mostly have a positive attitude towards pharmacovigilance. However, this does not translate into acceptable levels of participation in ADR reporting, most likely due to inadequate pharmacovigilance training provided to medical doctors and pharmacists in South Africa.