Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.

BACKGROUND: Information regarding off-label and unlicensed medicine use among South African children is limited. This is a concern as the prescribing of off-label and unlicensed medicines can lead to issues of effectiveness and safety as well as raise liability issues in the event of adverse events. This potentially exposes physicians to legal penalties. Consequently, we sought to determine the prevalence of off-label and unlicensed medicine use among paediatric patients in South Africa to provide future direction. METHODS: This study retrospectively examined the use of medicine in a point-prevalence survey study (PPS) involving paediatric patients aged (0-2 years) admitted to selected public hospitals in Gauteng Province, South Africa. Data were collected per hospital over two days between February 2022 and July 2022. Demographics, duration of treatment, diagnosis, and medicines prescribed were collected from patient medical records using a mobile application. Prescribed medicines were reviewed against the medicine formularies and other databases to assess their appropriateness. RESULTS: From three academic hospitals, 184 patient records were reviewed. A total of 592 medicines were dispensed, of which 379 (64.0%) were licensed and 213 (36.0%) were used off-label/unlicensed for paediatric patients 0-2 years of age. The most prevalent off-label and unlicensed medicines were multivitamins (n = 32, 15.0%) and ampicillin injections (n = 15, 7.0%). CONCLUSION: The frequency of unlicensed and off-label medicine prescribing shown in this study is consistent with the literature and can be considered high. This practice can pose a risk because it adversely affects patients if not properly regulated. Attention is needed to ensure future high-quality, safe, and effective use of medicines.

Estimated indirect costs of haemodialysis versus peritoneal dialysis from a patients' perspective at an Academic Hospital in Pretoria, South Africa.

In South Africa (SA), patients with kidney failure can be on either haemodialysis (HD), which is performed by a healthcare professional in a hospital thrice weekly; or peritoneal dialysis (PD), which can performed daily at home. There needs to be more studies within the South African healthcare sector on the cost of kidney failure and especially the indirect costs associated with patients being on dialysis to provide future guidance. This study aimed to determine and compare the indirect costs associated with HD and PD from the patients' perspective at an Academic Hospital in Pretoria. The study used a cross-sectional prospective quantitative study design. The researcher used face-to-face interviews to collect data and the human capital approach to calculate productivity losses. The study population included all patients over 18 receiving HD or PD for over three months; 54 patients participated (28 on HD and 26 on PD). The study lasted seven months, from September 2020 to March 2021. Haemodialysis patients incurred greater productivity losses per annum ($8127.55) compared to PD (R$3365.34); the difference was statistically significant with a P-value of p < 0.001. More HD (96.4%) patients were unemployed than (76.9%) PD patients.

Perceptions of and Preparedness for the Application of Pharmacoeconomics in Practice, among Final Year Bachelor of Pharmacy Students in South Africa: A National Cross-Sectional Study.

For the improvement of access to health, many countries including South Africa, have adopted universal healthcare. However, this requires skills to apply health technology assessments for the facilitation of investment decisions. This study aimed to ascertain final year Bachelor of Pharmacy (BPharm) students' perceptions of the relevance of pharmacoeconomics in pharmacy practice, and their level of preparedness to apply pharmacoeconomic principles, using a quantitative, cross-sectional, and descriptive design. Data were collected using a self-administered questionnaire over 12 months, and included student demographics, knowledge about pharmacoeconomics and its applicability in practice, as well as students' satisfaction with the appropriateness of the curriculum content. Five of nine universities offering pharmacy education took part. The overallstudent response rate was 38.1% (189/496), with 26.2% (45/172) of students signifying a good understanding of basic pharmacoeconomic concepts. Pharmacoeconomics application in South Africa was perceived to be relevant by 87.5% (140/160); however, 47.0% (79/168) felt they were not prepared to apply pharmacoeconomic principles in medicine management, and 86.7% (137/158) wanted to acquire additional pharmacoeconomic knowledge. Whilst students' perceptions of the relevance of pharmacoeconomics were positive, results indicated a gap in knowledge, understanding, and application. Addressing this gap may increase students' preparedness to apply pharmacoeconomic principles and better equip them for the practical application of pharmacoeconomics post qualification. Consequently, we have started this process.

Knowledge, attitudes and practices of healthcare professionals on the use of an electronic stock visibility and management tool in a middle-income country: Implications for access to medicines.

Background: The Stock Visibility System (SVS) is a mobile application and web-based management tool used at public primary health care (PHC) facilities in South Africa to capture and monitor medicines availability, providing visibility at national level. Medicine stock-outs are prevalent despite the implementation of SVS, compromising patient care. This study aimed to assess the knowledge, attitudes and practices (KAP) of healthcare professionals (HCPs) on the use of the SVS at PHC level to provide future guidance. Method: A cross-sectional study using a structured self-administered questionnaire among 206 HCPs at 21 randomly selected PHC facilities located in a health district in KwaZulu-Natal Province, South Africa. Closed-ended questions were used to collect data on socio-demographic characteristics, knowledge on the SVS and practices on its use. A Likert scale was used to determine attitudes towards the SVS. Cronbach's alpha (α) was used to assess the internal consistency of the questionnaire and independent samples t-test and one-way analysis of variance (ANOVA) was used to test statistical difference in the mean scores for KAP and socio-demographic variables. Association between knowledge and practices, and attitude and practices was determined using odds ratios (OR) and Chi-square. Results: The majority (99.5%) of HCPs had previous training on SVS. Nearly two thirds (62.1%; 128/206) generally had good knowledge about the SVS and 76.7% (158/206) had positive attitudes towards the SVS while only 17.0% had a good practice score. There was no statistically significant association between KAP of HCPs on the use of the SVS, and sociodemographic variables (HCP qualification, age and sex). There was a significant association between the knowledge and practice scores (aOR: 5.44; 95% CI: 1.92-15.4; p = 0.001). Although positive attitudes, was associated with good practices, it was not statistically significant (OR: 1.21; 95% CI: 0.46-3.22; p = 0.702). Conclusions: HCPs in this district had poor practices when using SVS despite good knowledge and positive attitudes towards SVS and the higher the HCPs knowledge of SVS, the more desirable the practices on SVS. This underscores the need for continuous training of HCPs to ensure a constant and efficient supply of medicines to meet the health needs of the population.

Performance of the school-based human papillomavirus vaccine uptake in Tshwane, South Africa.

Background: Human papillomavirus (HPV) vaccine is an effective preventive measure against HPV infection and HPV-associated cervical cancer. South Africa introduced its HPV vaccination programme in 2014. Objectives: The authors assessed the uptake of HPV vaccine in the school-based HPV vaccination programme in Tshwane Health District for the year 2019 and compared the vaccine uptake (VU) between fee-paying and no-fee public schools. Method: The study method was cross-sectional, using routine electronic health records of the HPV vaccination programme. The study population included all Grade 4 school-girls between the ages of 9 and 14 years who attended public schools in 2019 in the Tshwane Health District. Results: The pooled VU for the Tshwane Health District was 72.0%, considerably lower than the target of 80.0%. The number of girls who received dose one and dose two in 2019 was 16 122 (73.0%) and 15 734 (71.0%), respectively, excluding the catch-up figures. In addition, 82.2% of fee-paying schools achieved VU of above 80% versus 65.5% of no-fee schools (p = 0.022). Conclusion: The lower than target levels of VU for HPV among girls in Tshwane Health District, particularly in those attending no-fee schools, is concerning. Interventions should be adopted to optimise programme performance so as to achieve the target VU of 80%. Contribution: This study showed the need to strengthen sensitisation and social mobilisation efforts, particularly among no-fee schools to improve the VU.

Trends in the utilization of medicines sold in the private sector post- registration in South Africa and the implications for similar countries.

BACKGROUND: Regulatory authorities register medicines for patients to access them within a reasonable period of time. There is a paucity of available data regarding the extent to which registered medicines reach the public after market authorisation is granted by the South African Health Products Regulatory Authority (SAHPRA). This is important since time spent by SAHPRA assessing medicines that are subsequently not launched onto the South African market means time wasted, which could be spent on assessing new medicines that address an unmet need in the country. Consequently, we initially analysed the time taken for registered medicines to reach patients and the relationship between medicines registered at SAHPRA and those subsequently dispensed in private pharmacies. The extent of registration of multiple sourced versus new patented medicines was also explored. METHODS: A retrospective, descriptive and quantitative investigation was conducted for medicines registered between 2014 and 2019. Registered and dispensed medicines were compared to establish accessibility post registration. Data sources included SAHPRA and IQVIA datasets. Microsoft Excel and SAS were used for data storage, analysis, and computation of descriptive statistical analysis. RESULTS: Of (N = 2175) registered medicines, only 358 (16.5%; 95% CI 15.0%-18.1%) were dispensed to patients, and out of 1735 medicines registered between 2015 and 2019, only 57 (3.3%; 95% CI 2.5%-4.2%) were dispensed during the study period. Medicines acting on the central nervous system were registered and dispensed the most at 21.0% and 18.0%, respectively, whereas antineoplastic and immunomodulation agents were registered and dispensed only 11% and 5%, respectively. A concern was that only 13.0% of registered medicines were originators, with most either as generics, including branded generics, or pseudo-generics. CONCLUSION: Regulatory measures should be implemented to ensure increased medicine access post-registration for new originators, especially for priority disease areas that benefit patients. Mental health diseases and improved access to oncology medicines require special attention and further investigation in South Africa.

Market Women's Perspectives on Coronavirus Disease 2019 (COVID-19): The Case of Ghana and South Africa.

Globally, countries are still battling health challenges and the negative economic stress on the citizenry caused by COVID-19. This study explored the perspectives of market women in Ghana and South Africa on COVID-19. Data collection was executed in both Ghana and South Africa between March 2021 and December 2021. Employing semi-structured questionnaires, face-to-face interviews were conducted. Most of the market women in Ghana described COVID-19 as a global pandemic, while market women in South Africa described the disease as the deadly flu. There were similarities in the perceived signs and symptoms of COVID-19. Market women in both countries specifically observed that not adhering to the safety protocols was the major mode of transmission. Lemon, garlic and ginger were the most common foodstuffs used by the market women to fight COVID-19. To prevent COVID-19 at their places of work, market women stressed the importance of observing the safety protocols. An overwhelming majority of market women in both countries bemoaned the negative impact of COVID-19 on their businesses and suggested the need for financial assistance from their respective governments. The findings are intended to assist policymakers in both Ghana and South Africa to implement interventional projects to assist women whom the literature suggests are the most vulnerable during pandemics such as COVID-19.

Challenges and Innovations Brought about by the COVID-19 Pandemic Regarding Medical and Pharmacy Education Especially in Africa and Implications for the Future.

BACKGROUND: Multiple measures introduced early to restrict COVID-19 have dramatically impacted the teaching of medical and pharmacy students, exacerbated by the lack of infrastructure and experience with e-learning at the start of the pandemic. In addition, the costs and reliability of the Internet across Africa pose challenges alongside undertaking clinical teaching and practical programmes. Consequently, there is a need to understand the many challenges and how these were addressed, given increasingly complex patients, to provide future direction. METHOD: An exploratory study was conducted among senior-level medical and pharmacy educators across Africa, addressing four key questions, including the challenges resulting from the pandemic and how these were dealt with. RESULTS: Staff and student members faced multiple challenges initially, including adapting to online learning. In addition, concerns with the lack of equipment (especially among disadvantaged students), the costs of Internet bundles, and how to conduct practicals and clinical teaching. Multiple activities were undertaken to address these challenges. These included training sessions, developing innovative approaches to teaching, and seeking ways to reduce Internet costs. Robust approaches to practicals, clinical teaching, and assessments have been developed. CONCLUSIONS: Appreciable difficulties to teaching arising from the pandemic are being addressed across Africa. Research is ongoing to improve education and assessments.

Formulary Management Activities and Practice Implications Among Public Sector Hospital Pharmaceutical and Therapeutics Committees in a South African Province.

INTRODUCTION: The World Health Organization identified Pharmaceutical and Therapeutics Committees (PTCs) at district and hospital levels as one of the pivotal models to promote rational use of medicines (RUM). This is endorsed by the Government in South Africa. Formulary development and management is one of the main functions of PTCs. This study aimed to describe the formulary management activities among PTCs in public hospitals in Gauteng Province, South Africa, following initiatives to promote RUM in South Africa. METHODS: Qualitative, nonparticipatory, observational study, observing 26 PTC meetings. Data were coded and categorized using NVivo9® qualitative data analysis software. Themes and sub-themes were developed. The themes and sub-themes on formulary management are the principal focus of this paper. RESULTS: More than half of the observed PTCs reviewed their formulary lists. There was variation in the review process among institutions providing different levels of care. Various aspects were considered for formulary management especially requests for medicines to be added. These included cost considerations (mainly focusing on acquisition costs), evidence-based evaluation of clinical trials, patient safety, clinical experience and changes in the National Essential Medicines List (NEML). The tertiary PTCs mostly dealt with applications for new non-EML medicines, while PTCs in the other hospitals mainly requested removal or addition of EML medicines to the list. CONCLUSION: This is the first study from Gauteng Province, South Africa, reporting on how decisions are actually taken to include or exclude medicines onto formularies within public sector hospitals providing different levels of care. Various approaches are adopted at different levels of care when adding to- or removing medicines from the formulary lists. Future programs should strengthen PTCs in specialized aspects of formulary management. A more structured approach to formulary review at the local PTC level should be encouraged in line with the national approach when reviewing possible additions to the NEML.

Medicine shortages and challenges with the procurement process among public sector hospitals in South Africa; findings and implications.

BACKGROUND: Medicine shortages are a complex global challenge affecting all countries. This includes South Africa where ongoing medicine shortages are a concern among public sector hospitals as South Africa strives for universal access to healthcare. The objectives of this research were to highlight challenges in the current pharmaceutical procurement process for public sector hospitals. Subsequently, suggest potential ways forward based on the findings as the authorities in South Africa seek to improve the procurement process. METHOD: Qualitative in-depth interviews were conducted with 10 pharmacy managers in public sector hospitals in the Gauteng Province, South Africa. A thematic content analysis was performed, with transcripts coded by two of the authors. Coding was discussed until consensus was reached. Categories were developed and grouped into themes. RESULTS: The 'Procurement process' emerged from the data as the overarching theme, rooted in three main themes: (i) The buy-out process that was used to procure medicines from suppliers other than the contracted ones; (ii) Suppliers not performing thereby contributing to medicine shortages in the hospitals; and (iii) Challenges such as the inaccuracy of the electronic inventory management system used in the hospitals. CONCLUSIONS: Effective management of contracts of suppliers by the Provincial Department of Health is crucial to ensure accessibility and availability of essential medicines to all citizens of South Africa. Ongoing monitoring and support for the future use of computerised inventory management systems is important to reduce medicine shortages, and this is being followed up.

Availability and Use of Therapeutic Interchange Policies in Managing Antimicrobial Shortages among South African Public Sector Hospitals; Findings and Implications.

Abstract: Background: Therapeutic interchange policies in hospitals are useful in dealing with antimicrobial shortages and minimising resistance rates. The extent of antimicrobial shortages and availability of therapeutic interchange policies is unknown among public sector hospitals in South Africa. This study aimed to ascertain the extent of and rationale for dealing with antimicrobial shortages, describe policies or guidelines available, and the role of pharmacists in the process. METHODS: A quantitative and descriptive study was conducted with a target population of 403 public sector hospitals. Data were collected from hospital pharmacists using an electronic questionnaire via SurveyMonkeyTM. RESULTS: The response rate was 33.5% and most (83.3%) hospitals had experienced shortages in the previous six months. Antimicrobials commonly reported as out of stock included cloxacillin (54.3%), benzathine benzylpenicillin (54.2%), and erythromycin (39.6%). Reasons for shortages included pharmaceutical companies with supply constraints (85.3%) and an inefficient supply system. Only 42.4% had therapeutic interchange policies, and 88.9% contacted the prescriber, when present, for substitution. CONCLUSIONS: Antimicrobial shortages are prevalent in South African public sector hospitals with the most affected being penicillins and cephalosporins. Therapeutic interchange policies are not available at most hospitals. Effective strategies are required to improve communication between pharmacists and prescribers to ensure that safe, appropriate, and therapeutically equivalent alternatives are available.

Correction to: A Cost Analysis of Haemodialysis and Peritoneal Dialysis for the Management of End-Stage Renal Failure At an Academic Hospital in Pretoria, South Africa.

Multiple errors have been identified in the article including in the main findings.

A Cost Analysis of Haemodialysis and Peritoneal Dialysis for the Management of End-Stage Renal Failure At an Academic Hospital in Pretoria, South Africa.

BACKGROUND: Haemodialysis (HD) and peritoneal dialysis (PD) are commonly used treatments for the management of patients with end-stage renal disease (ESRD). The costs of managing these patients have grown in recent years with increasing rates of non-communicable diseases, which will adversely impact on national health budgets unless addressed. Currently, there is limited knowledge of the costs of ESRD within the public healthcare system in South Africa. OBJECTIVE: The aim of this study was to examine the direct costs of HD and PD in South Africa from a healthcare provider's perspective. METHODS: A prospective, observational study was undertaken at a leading public hospital in South Africa. A micro-costing approach was applied to estimate healthcare costs using 46 adult patients with ESRD who had been receiving HD and PD for at least 3 months. RESULTS: The highest proportion of patients (35%) were aged 40-50 years. Patients aged 29-39 years were mostly on HD (28% vs. 21% on PD) while those aged 51-59 years mostly used PD (29% vs. 16% on HD). The average age of patients on HD and PD were 41 and 42 years, respectively. Fixed costs were the principal cost driver for HD ($16,231.45) while variable costs were the principal cost driver for PD (US$20,488.79). The annual cost of HD per patient (US$31,993.12) was higher than PD (US$25,282.00 per patient), even though the difference was not statistically significant (p = 0.816). CONCLUSION: HD costs more than PD from the provider's perspective. These cost estimates may be useful for carrying out future cost-effectiveness and cost-utility analyses in South Africa.

Implementation and monitoring of decisions by pharmacy and therapeutics committees in South African public sector hospitals.

INTRODUCTION: The National Drug Policy in South Africa has achieved its objective in establishing and strengthening Pharmacy and Therapeutics Committees (PTCs) in public sector hospitals. However, little is known about the implementation of decisions by PTCs and the monitoring thereof. Consequently, there is a need to investigate this. Areas covered: We sought to address this via an online survey distributed to pharmacists working in public sector hospitals across South Africa with perceived functioning PTCs, with a 32.3% response rate to the survey. Expert commentary: Membership of all PTCs included a pharmacist, who in most cases (51.2%) held the secretariat position. Principal PTC activities were encouraging rational medicine use (RMU) (86.0%), pharmacovigilance (82.6%) and implementing standard treatment guidelines (STGs) (77.9%). Only a third (37.5%) stated that they were using indicators to monitor PTC performance. Where collected, indicator data were mostly used for providing feedback to PTCs (83.3%). Most hospitals (95.1%) implemented PTC decisions; however, 62.0% mentioned guidelines on implementing PTC decisions did not exist in their hospital. The majority of respondents (65.4% and 83.8%, respectively) indicated PTC decisions were evaluated and reviewed in their hospitals. Overall, a high percentage of respondents stated the main activities of PTCs were to enhance RMU as well as implement STGs. However, guidelines on implementation of decisions by PTCs are currently lacking and most PTCs were not monitoring their performance. This needs to be addressed.

Structure and activities of pharmacy and therapeutics committees among public hospitals in South Africa; findings and implications.

INTRODUCTION: The WHO identified Pharmacy and Therapeutics Committees (PTCs) as a pivotal model to promote rational medicine use in hospitals. This matches a key South African (SA) government objective to establish PTCs in all hospitals to ensure rational, efficient and cost-effective use of medicines. However, documentation on the functionality of PTCs in public hospitals in SA is limited. Areas covered: This study aimed to address this. A 3-phased mixed methods approach involving questionnaires, observations of PTC meetings and semi-structured interviews was used. The findings were converged during the interpretation phase. Expert commentary: Most professionals were represented in the PTCs, with variations across hospitals. Membership of PTCs included a pharmacist, who in the majority of cases was the secretary. PTC activities included dissemination of decisions (100%) and formulary management (89.5%). However, reporting of adverse drug reactions (ADRs) and medication errors was typically poor at all hospital levels. Lack of expertise of pharmacoeconomic analysis and evidence-based decision-making in formulary management was identified as a key challenge in formulary management. In conclusion, future programmes should strengthen PTCs in specialised aspects of formulary management. Further training in the principles of pharmacovigilance is needed to enhance ADR reporting, as well as to ensure compliance with both WHO and provincial guidelines.