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Abstract Background South Africa is composed of a two-tier healthcare system. One tier is a private healthcare system that is funded through medical insurance, and comprised of people who can afford to make monthly payments towards their medical insurance. Second tier is a government-funded public healthcare system, which covers the majority of the population. This study explored the perceived barriers and current strategies being utilised by the pharmaceutical industry to increase access to innovator medicines. Objectives The objectives of the study were to: (1) quantify and classify innovator medicines registered between 2010 and 2020 by the South African Health Products Regulatory Authority (SAHPRA); (2) identify barriers to accessing innovator medicines in South Africa through interviews with market access managers from innovator companies; and (3) explore the current market access strategies used by the pharmaceutical industry. Design This study employed a quantitative and qualitative methodology. Whereby the former involved the extraction of a list of innovator medicines from the regulator database, and the latter involved 9 semi structured interviews. Purposive sampling was conducted through pharmaceutical association member companies. The interviews included seven market access managers and two medicine managers from one of the payers in South Africa. Thematic analysis was used to interpret the data collected from the study. Results According to the regulator database during the review period, 238 innovator medicines were registered. Only 14.77% were available in the public sector in the form of tenders, whereas in the private sector (based on the products having a SEP), 76.92% were available. From the interviews six themes emerged: reimbursement of medicines, types of reimbursement, partnerships, technology, legislative challenges, and other factors (e.g., real-world evidence). Conclusion Access to innovator medicines in South Africa is a challenge, as the price of these therapies is high. Therefore, various stakeholders in the health sector must collaborate to identify and implement solutions that are locally relevant. The government needs to proactively update policies that would allow for alternative reimbursement methods to be explored.

Abstract Background A central challenge to closing the mental health treatment gap in low- and middle-income countries (LMICs) is determining the most effective pathway for delivering evidence-based mental health services. We are conducting a cluster-randomized, Type 2 hybrid implementation-effectiveness trial across 20 districts of Mozambique called the Partnerships in Research to Implement and Disseminate Sustainable and Scalable EBPs (PRIDE) program. Following training of nonspecialized providers in facilitation of evidence-based treatments for mental health and informed by the Consolidated Framework for Implementation Research (CFIR), we identified how PRIDE compares to care as usual and the perceived barriers and facilitators of implementation and modifications needed for widescale service delivery and scale-up. Methods We conducted rapid ethnographic assessment using freelisting among 34 providers, followed by four focus group discussions (n = 29 participants) with a subsample of psychiatric technicians and primary care providers from 14 districts in Nampula Province. We used Thematic Analysis to inductively apply open codes to transcripts and then deductively applied the CFIR domains and constructs to organize open codes. Results The main Outer Setting constructs relevant to implementation were recognition that patient mental health needs were significant. Additionally, numerous community-level characteristics were identified as barriers, including distance between clinics; shortage of providers; and low awareness of mental health problems, stigma, and discrimination among community members towards those with mental health struggles. The PRIDE program was perceived to offer a relative advantage over usual care because of its use of task-sharing and treating mental illness in the community. PRIDE addressed Inner Setting barriers of having available resources and training and provider low self-efficacy and limited knowledge of mental illness. Providers recommended leadership engagement to give support for supervision of other task-shared professionals delivering mental healthcare. Conclusions Primary care providers and psychiatric technicians in Mozambique perceived the relative advantage of the PRIDE program to address mental health treatment access barriers and offered recommendations for successful sustainment and scale up of integrated mental health care.

Abstract Background The magnitude of expired medicines in supply chains are increasing globally due to lack of strict control of the supply chain, poor storage management and oversupply of medicines. This situation is very serious in resource-poor countries, including Ethiopia, where the supply of medicines is limited. Therefore, this study aimed to assess the magnitude and the contributing factors of expired medicines in the Public Pharmaceutical Supply Chains of Western Ethiopia. Methods Explanatory sequential study design involving mixed quantitative and qualitative approach were employed among 62 public pharmaceutical supply chains of Western Ethiopia from July1 to August 30, 2021. An observational checklist and the self-administered questionnaire were used to review all records of the expired medicine file and to abstract secondary data on the extent, types of expired medicines and its contributing factors. The collected data was cleared, filtered, and coded using Microsoft Excel® 2010, and exported to SPSS version-23 (Amsterdam, Netherland) for statistical analysis. Bivariate logistic regression was used to check association between the outcome and independent variables. Multivariate logistic regression was analyzed when p-value is less than or equal to 0.25 in bivariate binary logistic regression, considering the statistical at p-value

Abstract Background Sustainable Development Goal (SDG) indicator 3.b.3 monitors progress in medicines’ accessibility for adults and has significant limitations when applying to medicines for children. An adapted indicator methodology was developed to fill this gap, but no proof of its robustness exists. We provide this evidence through sensitivity analyses. Methods Data on availability and prices of child medicines from ten historical datasets were combined to create datasets for analysis: Dataset 1 (medicines selected at random) and Dataset 2 (preference given to available medicines, to better capture affordability of medicines). A base case scenario and univariate sensitivity analyses were performed to test critical components of the methodology, including the new variable of number of units needed for treatment (NUNT), disease burden (DB) weighting, and the National Poverty Line (NPL) limits. Additional analyses were run on a continuously smaller basket of medicines to explore the minimum number of medicines required. Mean facility scores for access were calculated and compared. Results The mean facility score for Dataset 1 and Dataset 2 within the base case scenario was 35.5% (range 8.0–58.8%) and 76.3% (range 57.2–90.6%). Different NUNT scenarios led to limited variations in mean facility scores of + 0.1% and -0.2%, or differences of + 4.4% and -2.1% at the more critical NPL of $5.50 (Dataset 1). For Dataset 2, variations to the NUNT generated differences of + 0.0% and -0.6%, at an NPL of $5.50 the differences were + 5.0 and -2.0%. Different approaches for weighting for DB induced considerable fluctuations of 9.0% and 11.2% respectively. Stable outcomes with less than 5% change in mean facility score were observed for a medicine basket down to 12 medicines. For smaller baskets, scores increased more rapidly with a widening range. Conclusion This study has confirmed that the proposed adaptations to make SDG indicator 3.b.3 appropriate for children are robust, indicating that they could be an important addition to the official Global Indicator Framework. At least 12 child-appropriate medicines should be surveyed to obtain meaningful outcomes. General concerns that remain about the weighting of medicines for DB and the NPL should be considered at the 2025 planned review of this framework.

Abstract Background Quality of care is a multidimensional concept that forms an integral part of the uptake and use of modern contraceptive methods. Satisfaction with services is a significant factor in the continued use of services. While much is known about quality of care in the general public health care service, little is known about family planning specific quality of care in South Africa. This paper aims to fill the gap in the research by using the Bruce-Jain family planning quality of care framework. Methods This formative qualitative study was conducted in South Africa, Zambia, and Kenya to explore the uptake of family planning and contraception. The results presented in this paper are from the South African data. Fourteen focus group discussions, twelve with community members and two with health care providers, were conducted along with eight in-depth interviews with key informants. Thematic content analysis using the Bruce-Jain Quality of Care framework was conducted to analyse this data using NVIVO 10. Results Family planning quality of care was defined by participants as the quality of contraceptive methods, attitudes of health care providers, and outcomes of contraceptive use. The data showed that women have limited autonomy in their choice to either use contraception or the method that they might prefer. Important elements that relate to quality of care were identified and described by participants and grouped according to the structural or process components of the framework. Structure-related sub-themes identified included the lack of technically trained providers; integration of services that contributed to long waiting times and mixing of a variety of clients; and poor infrastructure. Sub-themes raised under the process category included poor interpersonal relations; lack of counselling/information exchange, fear; and time constraints. Neither providers nor users discussed follow up mechanisms which is a key aspect to ensure continuity of contraceptive use. Conclusion Using a qualitative methodology and applying the Bruce-Jain Quality of Care framework provided key insights into perceptions and challenges about family planning quality of care. Identifying which components are specific to family planning is important for improving contraceptive outcomes. In particular, autonomy in user choice of contraceptive method, integration of services, and the acceptability of overall family planning care was raised as areas of concern.

Abstract Background Prices of cancer medicines are a major contributor to the cost of treatment for cancer patients and the comparison of these cost needs to be assessed. Objectives To assess the prices of cancer medicines for the three most common cancers ((breast, prostate and colorectal) in the private healthcare sector of South Africa. Methods The methodology was adapted from the World Health Organization (WHO)/ Health Action International (HAI) methodology for measuring medicine prices. The Single Exit Price (SEP) variations between product types of the same medicine between the highest- and lowest-priced product and between Originator Brand (OB) and its Lowest Priced Generic (LPG) of the same medicine brand was compared, as of March 2020. The affordability of those medicines for cancer usage based on treatment affordability in relation to the daily wage of the unskilled Lowest-Paid Government Worker (LPGW) was also determined. Also, a comparison of the proportion of the population below the poverty line (PL) before (Ipre) and after (Ipost) procurement of the cancer medicines was determined. Results SEP Price differences ranged from 25.46 to 97.33% between highest- and lowest-priced products and a price variation of 72.09% more for the OB than the LPG medicine, except for one LPG that was more expensive than the OB. Affordability calculations showed that All OB treatments for all three cancers (breast, prostate and colorectal), except for paclitaxel 300 mg (0.2 days wage) and Fluorouracil (Fluroblastin) 500 mg (0.3 days wage) costs respectively were more than 1 day’s wage, with patients diagnosed with colorectal cancer needing 32.5 days wages in order to afford a standard course of treatment for a month. Conclusion There was a considerable variation in the price of different brands of cancer medicines available in the South African private sector.

Abstract Background Affordability and availability of quality medicines to all its citizens has been a key priority area for South Africa since democracy in 1994. In order to introduce transparency in the private market the government introduced the Single Exit Price (SEP) for medicines in 2004, for all prescription medicines, comprising of a fixed ex-factory price with a logistics fee component (and value added tax) for medicines sold to all purchasers other than the State. This is complemented with a provision for an annual regulated maximum percentage increase. The study evaluates the impact of the SEP on a basket of originator medicines, in terms of costs, immediate price reductions and projected price reductions. Method This is an analytical, quantitative study. A basket of medicines was selected, based on the WHO/HAI list, and adapted to include registered medicines in South Africa. Prices of 50 originator medicines were assessed from 1999 to 2014 in terms of the single exit price and the changes in prices in accordance with legislation using a time series analysis methodology. Results Of the 50 originator medicines investigated 35 showed a statistically significant change in level. For the Global Core list, the percentage change ranged from 2.45–39.12% (mean = 19.87%, SD = 10.62%, IQR = 10.2%). The range for the Regional Core list was 1.77–42.17% (mean = 23.38%, SD = 12.43%, IQR = 15.65%). The Supplementary list was 11.68–55.86% (mean = 22.97%, SD = 16.26%, IQR = 17.34). This study indicates that the SEP regulation had an impact on medicine pricing in South Africa in both the short and long term. Most medicines investigated showed a smaller yearly increase in price compared to before regulations due to the controlled pricing environment introduced by Government. Conclusion This study provides evidence of the impact of medicine pricing intervention from a middle–income country, and other developing countries looking at introducing medicine price controls can draw useful lessons.

Abstract Background Inadequate access to affordable essential medicines poses a challenge to achieving Universal Health Coverage. Access to essential medicines for children has been in the spotlight in recent research. However, information from the end users of medicines, i.e. patients is scarce. Obtaining information at a household level is integral to understanding how people access, obtain and use medicines. This study aimed to gather opinions and perceptions from parents/guardians on availability, affordability and quality of medicines and healthcare for children in SA. Methods Eight Focus group discussions were held with 41 individuals in eThekwini, South Africa (SA), from September–November 2016. Participants were parents/guardians of children up to 12 years from different ethnicities, ages, gender, and socio-economic backgrounds. Key informants identified by the principal researcher recruited participants using snowball sampling. Focus group discussions were recorded, transcribed verbatim, coded by the first author, verified by the second author, reconciled for consensus and imported into NVIVO for data analysis. Results Medicines and healthcare facilities are accessible in urban and peri-urban areas in eThekwini. Medicines may not always be available in public sector facilities due to medicine shortages, compelling parents to purchase medicines from private sector pharmacies. Common medicines were perceived as affordable for most socio-economic groups except the ‘Poor’ group. Quality of medicines was perceived as ‘good’ especially if obtained from the private sector but sometimes perceived as ‘poor’ and viewed with suspicion when received from public sector clinics. Quality of healthcare was perceived as ‘good’ but requires improvement for both sectors. Conclusions This is the first study in SA to report on parent/guardian perceptions on availability, affordability and quality of medicines and healthcare for children. It has the potential to be up-scaled to a country-wide investigation to paint a national picture of parents’ opinions of healthcare for children. This will allow for patient input into pharmaceutical and healthcare policy governing access to and availability of essential medicines and services within the country. The study recommends that patient input be sought to assess impact of policies on the intended target group in the country to ensure that the policy objectives are achieved.