Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)

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Browsing by Author "Bapoo, Rafik"

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    The availability of persons nominated for adverse drug reporting and associated challenges in Gauteng regional and district public hospitals
    (University of the Western Cape, 2019) Modau, Tumelo; Van Huyssteen, Mea; Bapoo, Rafik
    Background and Objectives: The reporting of adverse drug reactions (ADRs) is a major public health necessity. It is estimated that only six to 10 percent of all ADRs are reported worldwide. This number is far less than the actual cases of ADRs which occur in healthcare facilities. There appears to be lack of knowledge, awareness and willingness of healthcare professionals to report ADRs, which prompted some countries to nominate a person for ADR reporting in facilities. The objectives of this study were to ascertain which facilities had a nominated person or committee for ADR reporting, describe the knowledge and training of these individuals, describe the processes followed by the facilities for ADR reporting, determine the most commonly reported ADRs and causative drug classes, and, determine the factors which facilitate or hinder ADR reporting. Method: This was an exploratory, multicenter study. A structured questionnaire with closed and open-ended questions was used for data collection. The study was conducted in Gauteng province, where stratified non-random sampling was used to collect data in the selected regional and district public hospitals. Results: Six regional hospitals and five district hospitals participated in the study. Five (45.5%) of these hospitals had a person nominated for ADR reporting, of which all were pharmacists. All the respondents nominated for ADR reporting stated their knowledge and confidence in identification of ADRs as average and above. One (20%) of the nominated persons for ADR reporting did not have pharmacovigilance training. The reported number of ADRs over the past 12 months ranged between zero and 199. Only two (40%) of the hospitals with a nominated person for ADR reporting received feedback on the submitted reports from a committee. Only one (16.7%) of the six hospitals that did not have a nominated person or committee for ADR reporting had plans to nominate a person for this function. ADR reporting in these hospitals were performed by the pharmacy that collated the identified ADRs into a report and distributed these to the Pharmacy and Therapeutics Committee (PTC) and South African Health Products Regulatory Authority (SAHPRA). Only one hospital out of all the hospitals (n=11) did not use the national ADR reporting form and rather used an incident report. Out of all the participating hospitals, only two (18.2%) of the hospitals had an algorithm in place to assist with the identification of ADRs. The researcher went through the file where ADR reporting forms were kept for the past 12 months, and reported that the most commonly reported ADR type across participating facilities was allergic reactions such as rash and angioedema reported by eight of the facilities, followed by administration errors and quality issues each from three facilities. While the most frequently reported drug class associated with these ADRs included antiretrovirals (ARVs) and angiotensin converting enzyme (ACE) inhibitors reported at eight and six facilities, respectively. The most common challenge to ADR reporting at participating facilities was non-reporting of ADRs, followed by fear of litigation and patient’s unwillingness. Although all the hospitals in this study had facility PTCs, only one hospital had a pharmacovigilance subcommittee and the others included ADRs as an agenda point of the PTC meetings. Conclusion: Less than half of the facilities had a person nominated for ADR reporting. Pharmacists and the pharmacy were synonymous with ADR reporting as all nominated persons were pharmacists and in facilities were there were no nominated person, the responsible pharmacist was identified as the contact person for ADR reporting. Although all hospitals had PTCs, there was rarely a subcommittee dedicated to pharmacovigilance or ADR reporting, which culminated in a lack of feedback to healthcare workers that could promote it in the facility. Underreporting of ADRs by health care workers was the major challenge to effective ADR reporting as this function was considered to be too time consuming.
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    Knowledge-based integration of Zimbabwean traditional medicines into the National Healthcare System: A case study of prostate cancer
    (University of the Western Cape, 2017) Chawatama, Brighton Itayi; Bapoo, Rafik
    This study sought to identify the bottlenecks in the promotion of Zimbabwean Traditional Medicines (ZTMs) towards improving the national healthcare delivery system. The indigenous medicines lost value and recognition to the Conventional Western Medicines introduced by the British colonialist since 1871 and is still dominating the national healthcare delivery system. There are growing challenges to ensure accessibility of affordable drugs especially for primary healthcare. The World Health Organization (WHO) and United Nations (UN) is in support of re-engaging indigenous medical interventions to achieve the Millennium development goals. Indigenous Traditional Medicine Knowledge-Based Systems (ITMKS) form the basis of the main source of health care for about 80% of the population in the developing countries. The implementation of the Zimbabwe Traditional Medicines Policy (ZTMP) has been at a stand-still since inception in 2007. The research used mixed methods involving qualitative and quantitative approaches. Data was collected through desk and field research. Questionnaires and focus group discussions were used to record perceptions and attitudes of key informants. The stakeholders included Traditional Health Practitioners (THPs), Medical Doctors, Pharmacists, Medical Research Council of Zimbabwe (MRCZ) staff, Medicines Control Authority of Zimbabwe (MCAZ), Traditional Medical Practitioner’s Council (TMPC), Zimbabwe National Traditional Healers Association (Zinatha), Ministry of Health and Childcare, WHO, Higher Education Institutions (UZ School of Pharmacy staff and students), Christian Groups, NGOs and Prostate Cancer Patients in Harare CBD. The stakeholders sampling framework was obtained from the list of registered practitioners. The stakeholder mapping involved selection of 5 key informants from each focus group obtained through random selection. The Snowball sampling technique was used to follow the closest 5 key informants in each focus group. The key findings established that 80% of respondents agreed to the integration of ZTM. The major bottlenecks were lack of modern dosage forms and standardization to determine quality, safety and efficacy of the ZTM. The study suggests that in order to fast track the integration process, a bottom up implementation strategy providing ZTM advocacy, capacity building in the institutionalization and training of ZTMPs, pharmacists and CMP need to be engaged for a favorable and quick buy-in. The study also recommends further analysis of the Indigenous Knowledge Systems (IKS) areas of specialization in pharmaceutical practice in order to improve treatment outcomes.
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    Pharmacoeconomic evaluation in Egypt and its role in the medicine reimbursement
    (University of the Western Cape, 2018) Mohamed Khalil; Bapoo, Rafik
    Aim: The purpose of this research was to assess the validity of pharmacoeconomic evaluation in Egypt three years after the guideline was issued and analyse challenges and opportunities for improvement. Objectives: To conduct a literature review of pricing, medicine reimbursement, and pharmacoeconomic evaluation. Examine, in conjunction with relevant stakeholders, the progress of the pharmacoeconomic evaluation. To present examples of pharmacoeconomic evaluation deployment. To propose recommendations on how to optimize the pharmacoeconomic implementation. Methods: A literature review and a qualitative research method that was conducted using a semi-structured interview with stakeholders of the reimbursement process in Egypt. In addition, examples were analysed to determine the impact of pharmacoeconomic methods on medicine reimbursement in Egypt. Results: The Egyptian Pharmacoeconomic Evaluation Unit was established in 2013, it supports various reimbursement decisions, especially for new technologies. The unit evaluations depended mainly on the available international data. However, fragmentation of the health care system in Egypt is a major obstacle to progress. The guidelines are still non-compulsory for implementation, and accordingly some reimbursement committees do not consider its evaluation in its decision making. Conclusion and Recommendations: The pharmacoeconomic evaluation has demonstrated a good start in Egypt. To gain the full benefit of pharmacoeconomic evaluation, authorities need to consider reducing the complexity of health care system, setting clear strategies, building capabilities to improve pharmacoeconomic awareness; endorsing risk sharing strategy and building a proper health related information system along with creation of full Health Technology Assessment program. The above-mentioned recommendations could be associated together under the Universal Health Coverage road map that Egypt committed to achieve by 2030.