Browsing by Author "Ward, Kim"
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Item Analyzing implementation dynamics using theory-driven evaluation principles: lessons learnt from a South African centralized chronic dispensing model(BioMed Central, 2017) Magadzire, Bvudzai Priscilla; Marchal, Bruno; Mathys, Tania; Laing, Richard; Ward, KimBACKGROUND: Centralized dispensing of essential medicines is one of South Africa’s strategies to address the shortage of pharmacists, reduce patients’ waiting times and reduce over-crowding at public sector healthcare facilities. This article reports findings of an evaluation of the Chronic Dispensing Unit (CDU) in one province. The objectives of this process evaluation were to: (1) compare what was planned versus the actual implementation and (2) establish the causal elements and contextual factors influencing implementation. METHODS: This qualitative study employed key informant interviews with the intervention’s implementers (clinicians, managers and the service provider) [N = 40], and a review of policy and program documents. Data were thematically analyzed by identifying the main influences shaping the implementation process. Theory-driven evaluation principles were applied as a theoretical framework to explain implementation dynamics. RESULTS: The overall participants’ response about the CDU was positive and the majority of informants concurred that the establishment of the CDU to dispense large volumes of medicines is a beneficial strategy to address healthcare barriers because mechanical functions are automated and distribution of medicines much quicker. However, implementation was influenced by the context and discrepancies between planned activities and actual implementation were noted. Procurement inefficiencies at central level caused medicine stock-outs and affected CDU activities. At the frontline, actors were aware of the CDU’s implementation guidelines regarding patient selection, prescription validity and management of non-collected medicines but these were adapted to accommodate practical realities and to meet performance targets attached to the intervention. Implementation success was a result of a combination of ‘hardware’ (e.g. training, policies, implementation support and appropriate infrastructure) and ‘software’ (e.g. ownership, cooperation between healthcare practitioners and trust) factors. CONCLUSION: This study shows that health system interventions have unpredictable paths of implementation. Discrepancies between planned and actual implementation reinforce findings in existing literature suggesting that while tools and defined operating procedures are necessary for any intervention, their successful application depends crucially on the context and environment in which implementation occurs. We anticipate that this evaluation will stimulate wider thinking about the implementation of similar models in low- and middle-income countries.Item The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges(Frontiers in medicine, 2023) Ncube, Bakani Mark; Dube, Admire; Ward, KimIntroduction: In 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States. Methods: This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of Anglophone and Francophone AU Member States. The heads of NRAs and a senior competent person were contacted to complete self-administered questionnaires. Results: The perceived benefits of model law implementation include enabling the establishment of an NRA, improving NRA governance and decision-making autonomy, strengthening the institutional framework, having streamlined activities which attract support from donors, as well as enabling harmonisation, reliance, and mutual recognition mechanisms. The factors enabling domestication and implementation are the presence of political will, leadership, and advocates, facilitators, or champions for the cause. Additionally, participation in regulatory harmonisation initiatives and the desire to have legal provisions at the national level that allow for regional harmonisation and international collaboration are enabling factors. The challenges encountered in the process of domesticating and implementing the model law are the lack of human and financial resources, competing priorities at the national level, overlapping roles of government institutions, and the process of amending/repealing laws being slow and lengthy. Conclusion: This study has enabled an improved understanding of the AU Model Law process, the perceived benefits of its domestication, and the enabling factors for its adoption from the perspective of African NRAs. NRAs have also highlighted the challenges encountered in the process. Addressing these challenges will result in a harmonised legal environment for medicines regulation in Africa and be an important enabler for the effective operation of the African Medicines Agency.Item The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges(Frontiers Media, 2023) Ncube, Bakani Mark; Dube, Admire; Ward, KimIn 2016, the African Union (AU) Model Law on Medical Products Regulation was endorsed by AU Heads of State and Government. The aims of the legislation include harmonisation of regulatory systems, increasing collaboration across countries, and providing a conducive regulatory environment for medical product/health technology development and scale-up. A target was set to have at least 25 African countries domesticating the model law by 2020. However, this target has not yet been met. This research aimed to apply the Consolidated Framework for Implementation Research (CFIR) in analysing the rationale, perceived benefits, enabling factors, and challenges of AU Model Law domestication and implementation by AU Member States.Item Establishment of the African Medicines Agency: Progress, challenges and regulatory readiness(Springer Nature, 2021) Ncube, Bakani Mark; Dube, Admire; Ward, KimInsufcient access to quality, safe, efcacious and afordable medical products in Africa has posed a signifcant challenge to public health for decades. In part, this is attributed to weak or absent policies and regulatory systems, a lack of competent regulatory professionals in National Medicines Regulatory Authorities (NMRAs) and inefective regional collaborations among NMRAs. In response to national regulatory challenges in Africa, a number of regional harmonisation eforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the AU Model Law on Medical Products Regulation. The goals of the model law include to increase collaboration across countries and to facilitate the overall regional harmonisation process. The AMRH initiative is proposed to serve as the foundation for the establishment of the African Medicines Agency (AMA). The AMA will, as one of its mandates, coordinate the regional harmonisation systems that are enabled by AU Model Law domestication and implementation. In this paper, we review the key entities involved in regional and continental harmonisation of medicines regulation, the milestones achieved in establishing the AMA as well as the implementation targets and anticipated challenges related to the AU Model Law domestication and the AMA’s establishment. This review shows that implementation targets for the AU Model Law have not been fully met, and the AMA treaty has not been ratifed by the minimum required number of countries for its establishment. In spite of the challenges, the AU Model Law and the AMA hold promise to address gaps and inconsistencies in national regulatory legislation as well as to ensure efective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level. Furthermore, this review provides recommendations for future research.Item Frontline health workers as brokers: provider perceptions, experiences and mitigating strategies to improve access to essential medicines in South Africa(Springer Nature, 2014) Magadzire, Bvudzai Priscilla; Budden, Ashwin; Ward, Kim; Jeffery, Roger; Sanders, DavidBackground: Front-line health providers have a unique role as brokers (patient advocates) between the health system and patients in ensuring access to medicines (ATM). ATM is a fundamental component of health systems. This paper examines in a South African context supply- and demand- ATM barriers from the provider perspective using a five dimensional framework: availability (fit between existing resources and clients’ needs); accessibility (fit between physical location of healthcare and location of clients); accommodation (fit between the organisation of services and clients’ practical circumstances); acceptability (fit between clients’ and providers’ mutual expectations and appropriateness of care) and affordability (fit between cost of care and ability to pay). Methods: This cross-sectional, qualitative study uses semi-structured interviews with nurses, pharmacy personnel and doctors. Thirty-six providers were purposively recruited from six public sector Community Health Centres in two districts in the Eastern Cape Province representing both rural and urban settings. Content analysis combined structured coding and grounded theory approaches. Finally, the five dimensional framework was applied to illustrate the interconnected facets of the issue. Results: Factors perceived to affect ATM were identified. Availability of medicines was hampered by logistical bottlenecks in the medicines supply chain; poor public transport networks affected accessibility. Organization of disease programmes meshed poorly with the needs of patients with comorbidities and circular migrants who move between provinces searching for economic opportunities, proximity to services such as social grants and shopping centres influenced where patients obtain medicines. Acceptability was affected by, for example, HIV related stigma leading patients to seek distant services. Travel costs exacerbated by the interplay of several ATM barriers influenced affordability. Providers play a brokerage role by adopting flexible prescribing and dispensing for ‘stable’ patients and aligning clinic and social grant appointments to minimise clients’ routine costs. Occasionally they reported assisting patients with transport money. Conclusion: All five ATM barriers are important and they interact in complex ways. Context-sensitive responses which minimise treatment interruption are needed. While broad-based changes encompassing all disease programmes to improve ATM are needed, a beginning could be to assess the appropriateness, feasibility and sustainability of existing brokerage mechanisms.Item The implementation of the African union model law on medical products regulation and the establishment of the African medicines agency(University of the Western Cape, 2022) Ncube, Bakani Mark; Ward, KimWithin Africa, there is insufficient access to quality, safe, efficacious and affordable medical products which can partly be attributed to lack of robust regulatory systems, a lack of competent regulatory professionals in national medicines regulatory authorities (NMRAs) and ineffective regional collaborations among NMRAs. In response to national regulatory challenges, a number of regional harmonisation efforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the African Union (AU) Model Law on Medical Products Regulation.Item Inefficient procurement processes undermine access to medicines in the Western Cape Province of South Africa(Health and Medical Publishing Group (HMPG), 2017) Magadzire, Bvudzai Priscilla; Ward, Kim; Leng, H.M.J.; Sanders, DavidBACKGROUND. South Africa (SA) has experienced several stock-outs of life-saving medicines for the treatment of major chronic infectious and non-communicable diseases in the public sector. OBJECTIVE. To identify the causes of stock-outs and to illustrate how they undermine access to medicines (ATM) in the Western Cape Province, SA. METHODS. This qualitative study was conducted with a sample of over 70 key informants (frontline health workers, sub-structure and provincial health service managers). We employed the critical incident technique to identify significant occurrences in our context, the consequences of which impacted on access to medicines during a defined period. Stock-outs were identified as one such incident, and we explored when, where and why they occurred, in order to inform policy and practice. RESULTS. Medicines procurement is a centralised function in SA. Health service managers unanimously agreed that stock-outs resulted from the following inefficiencies at the central level: (i) delays in awarding of pharmaceutical tenders; (ii) absence of contracts for certain medicines appearing on provincial code lists; and (iii) suppliers’ inability to satisfy contractual agreements. The recurrence of stock-outs had implications at multiple levels: (i) health facility operations; (ii) the Chronic Dispensing Unit (CDU), which prepacks medicines for over 300 000 public sector patients; and (iii) community-based medicines distribution systems, which deliver the CDU’s prepacked medicines to non-health facilities nearer to patient homes. For instance, stock-outs resulted in omission of certain medicines from CDU parcels that were delivered to health facilities. This increased workload and caused frustration for frontline health workers who were expected to dispense omitted medicines manually. According to frontline health workers, this translated into longer waiting times for patients and associated dissatisfaction. In some instances, patients were asked to return for undispensed medication at a later date, which could potentially affect adherence to treatment and therapeutic outcomes. Stock-outs therefore undermined the intended benefits of ATM strategies. Conclusion. Addressing the procurement challenges, most notably timeous tender awards and supplier performance management, is critical for successful implementation of ATM strategies.Item Medicines regulatory science expertise in Africa: workforce capacity development and harmonisation activities towards the establishment of the African medicines agency(Adis, 2022) Dube, Admire; Ncube, Bakani Mark; Ward, KimThe medicines regulatory landscape in Africa is undergoing transformation with at least two countries having National Medicines Regulatory Authorities (NRAs) that operate at World Health Organization (WHO) maturity level 3. However, this represents the exception as over 90% of African NRAs have limited capacity to perform core medicine regulatory functions, have a shortage of competent regulatory professionals, have high staff turnover, lack diversity of scientific expertise, and have staffing shortages relative to the high workload. A systematic approach to developing the regulatory workforce is therefore crucial to addressing the existing shortfalls in regulatory capacity, particularly at this time when efforts are underway to operationalise the African Medicines Agency (AMA). In this article, initiatives that are building African NRAs’ regulatory capacity and developing their workforce are reviewed in preparation for work to be conducted by the AMA. We found that the African Medicines Regulatory Harmonisation (AMRH) initiative has been at the forefront of capacity building and workforce development mainly through the designation of specialised Regional Centres of Regulatory Excellence and the implementation of medicines regulatory harmonisation initiatives in regional economic communities. In addition, some NRAs within high-income countries and trusted institutions have been supporting regulators in low-income countries with registration assessments and facilitating access to quality-assured medical products through their stringent review procedures (SRPs). Capacity building has subsequently been facilitated through this active involvement of African regulators in SRPs. This article also provides recommendations for further capacity building and workforce development. © 2022, The Author(s), under exclusive licence to Springer Nature Switzerland AG.Item Perceptions of the pharmaceutical industry and regulators in South Africa towards registration harmonisation in the Southern African Development Community (SADC)(University of the Western Cape, 2021) Dhanraj, Keshnee; Dube, Admire; Ward, KimMedicines have to be regulated in an effort to monitor their quality, safety, and efficacy. The process of medicines registration is lengthy, costly, and document-heavy. Many countries have limited expertise and resources at national medicines regulatory authorities (NMRAs) and some countries have adopted unified approaches to medicines registration legislation. Harmonised guidelines and initiatives have been adopted in South Africa and the Southern African Development Community (SADC). However, there are no studies that have identified the effects of these initiatives and guidelines on major stakeholders such as the pharmaceutical industry and regulators.Item Post-market assessment of the quality of first line regimen fixed-dose combination antiretrovirals in South Africa(University of the Western Cape, 2017) Suleiman, Reem Abdallah S.; Ward, Kim; Dube, AdmireThe rapid increase in access to new antiretrovirals (ARVs) worldwide and, especially in sub-Saharan Africa, coupled with the well-documented problem of poor quality ARVs in developing countries has underscored the need for quality assessment of these medicines. South Africa has the worst human immunodeficiency virus (HIV) epidemic profile in the world; consequently, it has rolled out the world's largest antiretroviral ARV programme. With increasing market penetration of generic medicine in South Africa and especially ARVs, there is a call for stringent quality control mechanisms following the marketing approval (post-market quality control) of these medications. Unfortunately, evidence suggests that the World Health Organisation (WHO) recommendations for this aspect of quality assurance is not met by most Medicine Regulatory Authorities. In South Africa and many other countries this is attributed to a lack of physical and financial resources to enforce effective post-marketing surveillance (PMS) of all pharmaceuticals available in the country.Item A post-market quality assessment of first-line, fixed-dose combination antiretrovirals in South Africa(Journal of Applied Pharmaceutical Science, 2019) Ward, Kim; Suleiman, Reem; Kippie, YunusSouth Africa has the world’s largest antiretroviral (ARV) program and despite having stringent upstream medicine’s regulatory oversight, the post-market reassessment of ARV quality is prohibitively resource intensive. The aim of this study was to evaluate and compare the post-market quality of four fixed-dose combination (FDC) generics containing efavirenz (EFV) 600 mg, emtricitabine 200 mg, and tenofovir 300 mg against the innovator, Atripla® and according to the International Pharmacopoeia (IP). Generic tablet samples, sourced from a South African provincial depot, were subjected to the identification, content assay, dissolution, uniformity of weight and disintegration tests. An in-house reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated in lieu of the RP-HPLC IP method which proved to be unsuitable. All samples passed the identification, assay, uniformity of weight and disintegration tests and one generic FDC failed the dissolution test (at both stage 1 and 2), releasing 62.23% (standard deviation 20.43) of EFV in 30 minutes. One generic first-line ARV combination that is currently supplied to the South African public health sector was found to be substandard and this reinforces the need for routine ARV post-market surveillance, as well as reliable compendial methods to facilitate this undertaking.Item Provision of syndromic treatment of sexually transmitted infections by community pharmacists: a potentially underutilized HIV prevention strategy(Lippincott, Williams & Wilkins, 2003) Ward, Kim; Butler, Nadine; Mugabo, Pierre; Klausner, Jeffrey; Mcfarland, Willi; Chen, Sanny; Schwarcz, SandraBackground: Sexually transmitted infections (STIs) are known risk factors for HIV infection. Goal: The goal of this study was to assess the current and potential future role that community pharmacists in Western Cape, South Africa play in the treatment of STIs. Study Design: A cross-sectional survey of community pharmacists in the Western Cape region of South Africa. A face-to-face interview that ascertained experience with requests from patients for STI treatment, current STI treatment practices, and willingness to provide syndromic STI treatment was administered to head pharmacists. Results: Ninety pharmacies were selected and 85 (94%) of the head pharmacists participated; 55 from an urban area and 30 from a rural area. Pharmacists reported a median of 40 urban clients and 25 rural clients who sought STI treatment from community pharmacists. When provided with a hypothetical clinical situation, 13% of urban and 17% of rural pharmacists identified the correct medication for male urethral discharge, 8% of urban pharmacists and none of the rural pharmacists identified correct treatment for genital ulcers, and none of the pharmacists identified the correct medication for vaginal discharge. Fifty-three percent of pharmacists in urban regions and 47% of pharmacists in rural regions expressed willingness to provide syndromic STI treatment. Independent predictors of willingness to provide syndromic treatment were knowledge of the link between HIV transmission and STIs (adjusted odds ratio [OR]: 13.78; 95% CI: 2.69,70.66), past experience prescribing syndromic STI treatment (OR: 11.1; 95% CI: 1.14, 108.6), and male gender (OR: 4.38; 95% CI: 1.15, 16.7). Conclusions: Pharmacists are frequently called upon to provide STI treatment but have limited knowledge of correct treatment recommendations. Training pharmacists to provide syndromic STI treatment may be one strategy to reduce STI morbidity and HIV transmission.Item Reasons for missed appointments linked to a public-sector intervention targeting patients with stable chronic conditions in South Africa: results from in-depth interviews and a retrospective review of medical records(BioMed Central, 2017) Magadzire, Bvudzai P.; Mathole, Thubelihle; Ward, KimBACKGROUND Missed appointments serve as a key indicator for adherence to therapy and as such, identifying patient reasons for this inconsistency could assist in developing programmes to improve health outcomes. In this article, we explore the reasons for missed appointments linked to a centralised dispensing system in South Africa. This system dispenses pre-packed, patient-specific medication parcels for clinically stable patients to health facilities. However, at least 8%–12% of about 300,000 parcels are not collected each month. This article aims to establish whether missed appointments for collection of medicine parcels are indicative of loss-to-follow-up and also to characterise the patient and health system factors linked to missed appointments. METHODS We applied an exploratory mixed-methods design in two overlapping research phases. This involved in-depth interviews to yield healthcare practitioners’ and patients’ experiences and medical record reviews. Data collection was conducted during the period 2014–2015. Qualitative data were analysed through a hybrid process of inductive and deductive thematic analysis which integrated data-driven and theory-driven codes. Data from medical records (N = 89) were analysed in MS excel using both descriptive statistics and textual descriptions. RESULTS Review of medical records suggests that the majority of patients (67%) who missed original appointments later presented voluntarily to obtain medicines. This could indicate a temporal effect of some barriers. The remaining 33% revealed a range of CDU implementation issues resulting from, among others, erroneous classification of patients as defaulters. Interviews with patients revealed the following reasons for missed appointments: temporary migration, forgetting appointments, work commitments and temporary switch to private care. Most healthcare practitioners confirmed these barriers to collection but perceived that some were beyond the scope of health services. In addition, healthcare practitioners also identified a lack of patient responsibility, under-utilisation of medicines and use of plural healthcare sources (e.g. traditional healers) as contributing to missed appointments. COCLUSION We suggest developing a patient care model reflecting the local context, attention to improving CDU’s implementation processes and strengthening information systems in order to improve patient monitoring. This model presents lessons for other low-and-middle income countries with increasing need for dispensing of medicines for chronic illnesses.Item Review of the effectiveness of the medicines regulatory systems in Zambia over the period 1995 to 2015(University of the Western Cape, 2018) Kabali, Emmanuel; Ward, KimDue to inadequacy of data on the effectiveness of medicines regulatory systems in Zambia, this study was framed. The aim was to evaluate legislative provisions for medicines regulation under three legalregulatory- frameworks in place over the period from 1995 to 2015. The study was structured in two distinct phases: the first involved document review of available legislation and secondary data relevant to the subject matter, covering the study period; the second involved a questionnaire survey for health practitioners to gather opinions on the effectiveness of the medicines regulatory systems in Zambia. Assessment of secondary data reported by Ministry of Health, and World Health Organisation on treatment outcomes and medicines regulation was conducted. Reviewed data showed relative reduction in incidence of some selected diseases of national importance. It was also evident that the regulatory systems had improved considerably over the study period. Responses from Health Practitioners and other players in the health and pharmaceutical sectors indicated that they were aware of medicines regulatory requirements, supported the need for medicines regulation, and indicated the need for regional collaboration and increased public awareness raising as means for improving current medicines regulatory systems. It was recommended that more comprehensive studies be undertaken to establish causal relationships between medicines regulatory systems, and disease outcomes. A further recommendation was made to implement more integrated information management systems in the Ministry of Health, and the Zambia Medicines Regulatory Authority.Item Review of the effectiveness of the medicines regulatory systems in Zambia over the period 1995 to 2015(University of the Western Cape, 2018) Kabali, Emmanuel; Ward, KimDue to inadequacy of data on the effectiveness of medicines regulatory systems in Zambia, this study was framed. The aim was to evaluate legislative provisions for medicines regulation under three legalregulatory- frameworks in place over the period from 1995 to 2015. The study was structured in two distinct phases: the first involved document review of available legislation and secondary data relevant to the subject matter, covering the study period; the second involved a questionnaire survey for health practitioners to gather opinions on the effectiveness of the medicines regulatory systems in Zambia. Assessment of secondary data reported by Ministry of Health, and World Health Organisation on treatment outcomes and medicines regulation was conducted. Reviewed data showed relative reduction in incidence of some selected diseases of national importance. It was also evident that the regulatory systems had improved considerably over the study period. Responses from Health Practitioners and other players in the health and pharmaceutical sectors indicated that they were aware of medicines regulatory requirements, supported the need for medicines regulation, and indicated the need for regional collaboration and increased public awareness raising as means for improving current medicines regulatory systems. It was recommended that more comprehensive studies be undertaken to establish causal relationships between medicines regulatory systems, and disease outcomes. A further recommendation was made to implement more integrated information management systems in the Ministry of Health, and the Zambia Medicines Regulatory Authority.Item Understanding the dynamics of accessing chronic medicines in the public sector: Implications for policy in South Africa(University of the Western Cape, 2016) Magadzire, Bvudzai Priscilla; Ward, Kim; Marchal, BrunoAccess to medicines (ATM), specifically for those medicines that are related to the priority health needs of a population has been cited as a fundamental part of universal health coverage and a key element for service delivery and high-quality care. Therefore, ensuring reliable access to and appropriate use of safe, effective and affordable medicines is one of the core functions of an effective health system. With the rising demand for treatment of chronic diseases (e.g. HIV, diabetes and hypertension), ATM has increasingly received global attention. Yet as of 2011, it was estimated that at least one third of the world's population had no regular access to medicines. Globally, there is a dearth of in-depth country level evidence to influence policy responses, coupled with inadequate understanding of how pharmaceutical systems operate within broader health systems. This thesis comprises two main parts: 1) a situational analysis of the state of chronic medicines provision in the public sector in the Eastern Cape and Western Cape provinces of South Africa; and (2) an evaluation of an existing ATM model in one province. To situate this study within the ATM discourse, a conceptual framework was developed from a review of empirical and theoretical literature. The framework incorporated six ATM dimensions (availability, affordability, acceptability, accessibility, accommodation and quality) and their interplay at multiple levels including: health facility, individual, household and community levels. Then, at a health system level, the interaction of medicines (a health system building block) with other building blocks (information, financing, human resources, infrastructure and governance).