Clinical Pharmacology

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This division was known as Pharmacology until 27 June 2013.

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Browsing Clinical Pharmacology by browse.metadata.advisor "Page, Carine"

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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.
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    Development of a direct ADR reporting tool for patients to address under-reporting of ADRs to the National Pharmacovigilance Unit in South Africa
    (Stellenbosch : Stellenbosch University, 2022-12) Maluleke, Tirhani Lineth; Page, Carine; Allen, Elizabeth; Reuter, Helmuth; Faculty of Medicine and Health Sciences. Dept. of Medicine. Division of Clinical Pharmacology.
    ENGLISH ABSTRACT: High standards of public health can be achieved through efficient and safe utilisation of healthcare products and the continuous monitoring thereof. Pharmacovigilance (PV), defined as the science and activities relating to the monitoring of adverse reactions associated with all medicines, is however hampered by the global under-reporting of adverse drug reactions (ADRs) by healthcare professionals. Several countries have successfully incorporated direct patient reporting into their PV system as a means of addressing the under-reporting challenge. Innovative ADR reporting tools have the potential to enable PV systems through increasing signal detection, assessment, understanding and prevention of adverse effects. Whilst the proof-of-concept of such tools have been promising, the use thereof by patients and consumers with access to the South African healthcare system has not been tested. The aim of the current study is to develop an ADR reporting tool for use by consumers in reporting ADRs to address under-reporting in South Africa. The design of the current study and the development of a patient/consumer ADR reporting tool precedes the adoption and implementation of the Med Safety Mobile Application as an online Adverse Event Following Immunisation (AEFI) reporting tool by the South African Health Products Regulatory Authority (SAHPRA) in 2021. If it had not been for the outbreak of the COVID-19 pandemic in 2020 and the immediate need for AEFI reporting tools following the global roll-out of immunisation programmes shortly thereafter by the World Health Organisation (WHO), National Health Departments and Regulators around the globe, this study would have been one of the first to have investigated direct consumer reporting on a larger scale in South Africa. The standard South African Health Products Regulatory Authority (SAHPRA) Yellow Form was used as a frame reference for designing an online-based consumer ADR reporting tool, which is compatible with a mobile application and a paper-based version. Validation and reliability testing of the tool was carried out in two stages: A content validation by healthcare professionals determined whether the content of the tool is appropriate and relevant for the designed purpose of ADR reporting by consumers/patients and face validation by consumers evaluated the usability of the tool in terms of readability, how clear/easy to follow the instructions and/or provide the required information. The developed and tested ADR reporting tool consists of five main elements: consumer’s details, consumer’s medical history, ADR details, suspected medicine(s), and reporter details. All items included received a majority inter-agreement rating of over 80% each as relevant to include in the tool, except for the reporter initials, the batch number and expiry date of the suspected medicine. Using the McNemar Chi-square test, the test and re-test responses of face validation showed no significant difference in responses across all items in the ADR reporting tool. Feasibility testing to assess the ease with which the ADR reporting tool could be used, how practical it is to access the tool and submit the report through it was carried out over a period of 1 year and 3 months. Participants were recruited from twelve healthcare centres and through social media, and they have completed and submitted ADR reports via online tool. A total of 348 reports were received with female consumers contributing 58.3% most of which were from those aged 31- 40 years (22.5%). These were associated with birth control medicines, the fourth highest suspected medicines reported (13.5%) with all reported ADRs listed as expected in the respective package inserts. Hydrochlorothiazide (52.17%) and enalapril (27.54%) were the most frequently suspected medicines within the antihypertensive class. All suspected medicines had well-established safety profiles, except for a lamivudine, tenofovir disoproxil fumarate and dolutegravir fixed-dose combination, nine reports related to investigational medicinal products and twenty-three suspected medicines which could not be identified. Expectedness of reported ADRs was confirmed in 73.9% of the suspected medicines, with dose reduction in 3.4%, treatment changed in 1.8% and treatment stopped in 6.9% of the consumers. A total of 5.3% of suspected medicines could not be verified as the names could not be recognised. Only two reports were received from healthcare professionals with the completeness and terminology used being similar to those of non-healthcare professionals. Reported terms produced 63.4% ‘exact matches’ from the MedDRA search, 8.7% were from ‘contains search’ results and terms used from ‘lexicant variant’ results amounted to 2.5%. Over 25% of the reported terms could not be found in the MedDRA database and therefore an alternative term was used. The high response rate in this study as well as the manner in which the consumers completed the ADR reports demonstrates their understanding and feasibility of using the tool to consistently submit ADR reports whose information would enable causality assessment over time, which will also boost the local PV system. However, the use of English only in the study limited participation of consumers who cannot use and/or understand the language. There was also no measure on the readability index conducted and causality assessment was not carried out. With consumer reporting being relatively new in South Africa, this study can be used as a basis to assess and improve on the newly introduced SAHPRA ADR reporting tools. Further studies are needed to assess the interest, understanding and factors influencing consumers to report ADRs.