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

Adverse drug reactions in a South African HIV clinic cohort over a 5-year period; findings and future implications

Background: Adverse drug reactions (ADRs) contribute to morbidity and mortality, which in many cases are preventable. Pharmacovigilance plays an important role in the detection, assessment and prevention of these ADRs. Objective: This study aimed to ascertain the association of ADRs with antiretroviral and concomitant medicines in a country with high rates of HIV. Methods: Retrospective cohort study using data extracted from 595 patient files enrolled on ART, ≥15 years and receiving ART at the facility from April 2013 to December 2018. Bivariate analyses were performed to test for association of factors potentially associated with ADRs. All statistical tests were two-tailed with p <0.05 considered statistically significant. Results: ADRs were reported in 58.9% (349/595) of the patients. Eighty-seven point five percent (523/595) of the patients were receiving concomitant medicines. A total of 904 ADRs were reported, of which the most common included general body pain (n = 111, 12.0%), headache (n = 82, 8.9%), and facial and oral sores (n = 78, 8.6%). No significant association was found between ADRs and concomitant medicines. A significant association was found between ADRs and CD4+ counts ≤ 350 cells/mm3 (p<0.015) and with different age categories (p<0.001) with the 10 most prominent ADRs. Conclusion: Special attention should be given to patients with a low CD4+ count and patients older than 30 years, especially in the first 6 months of treatment, as this is the period where patients are most vulnerable to ADRs

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

Knowledge, attitudes and practices of healthcare professionals on use of the stock visibility system for reporting medicines availability in South Africa : implications for the future

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

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

In South Africa (SA), End Stage Renal Disease (ESRD) patients can be on either Haemodialysis (HD), which is performed by a health care professional in hospital thrice weekly; or they could be on Peritoneal dialysis (PD) which they can perform daily at home. There is a lack of studies within the South African health care sector on the cost of ESRD and especially the indirect costs associated with being on dialysis. The aim of this study is to determine and compare the indirect costs associated with HD and PD from the patients perspective at Dr George Mukhari Academic Hospital (DGMAH) situated 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 the age of 18 who have been receiving HD or PD for more than three months, 54 patients participated (28 on HD and 26 on PD). The study took place for a period of seven months, from September 2020 to March 2021. Haemodialysis patients incurred greater productivity losses per annum (R132987.02) compared to PD (R55065.43), the difference was statistically significant with a P-value of 0.000. More HD (96.4%) patients were unemployed compared to (76.9%) PD patients

Availability and use of therapeutic interchange policies in managing antimicrobial shortages among South African public sector hospitals; findings and implications

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 and rationale for dealing with antimicrobial shortages and describe policies or guidelines 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 there 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

Cost analysis for HD and peritoneal dialysis for ESRD in South Africa

Introduction: Hemodialysis (HD) and peritoneal dialysis (PD) are commonly used to treat patients with end-stage renal disease (ESRD). However, their costs have grown considerably in recent years as the rates of non-communicable diseases including diabetes and hypertension have grown. This will adversely impact on national health budgets especially in LMICs. Currently, there is limited knowledge about the costs of ESRD and the different components within the public healthcare system in South Africa. Consequently, our objective was to examine the direct medical costs of both approaches from a public provider perspective to provide future guidance. Methods: A prospective observational study undertaken at a leading public hospital in South Africa based principally on patients’ notes and costs from nationally procured lists. A micro-costing approach was used to estimate health care costs among adult patients with ESRD who had received either HD and PD for at least 3 months. Results: The majority of patients (35%) were aged 40 to 50 years. Patients aged 29-39 years were mostly on HD (28%) while those between 51-59 years mostly on PD (29%), with HD typically managed in the private sector with limited facilities in the public sector. The average age of patients on HD and PD were 41 and 42 years respectively. Variable costs (HD; US$172, 359.15, PD; US$20, 488.79) were the highest cost component for both HD and PD patients. The annual cost of HD (US$205,681.4) was higher than PD (US$25,282 per patient) even though the difference was not statistically significant (p = 0.175). The overall burden if appreciably more patients with ESRD are managed appropriately within the public system (covering 80% of the population) would be considerable and become unaffordable. Conclusion: HD costs more than PD. These cost estimates are useful for carrying out future health economic analyses and for allocating greater resources to prevent progress to ESRD

Adverse drug reactions in HIV-infected patients registered at four sentinel sites in South Africa

Background: HIV and TB are common infections in sub-Saharan Africa. Due to HIV’s suppression of the immune system, infected patients are prone to opportunistic infections. Co-treatment of HIV and TB places patients at risk of adverse drug reactions (ADRs) and drug interactions. This study aimed to determine the incidence and risk factors for ADRs in HIV-infected patients and those co-infected with TB. Methods: Data from patients (aged >15 years) enrolled on the Medunsa National Pharmacovigilance Centre’s database from March 2007 to May 2017 were analysed. Censoring targeted the first incident of ADRs in HIV-TB co-infected patients and those not co-infected. A Cox-proportional hazard model was used to determine associations of dependant variables and identify predictors for developing ADRs. Results: 3608 HIV-infected patients were included. 12% (n=437) had HIV-TB co-infection. Overall prevalence of ADRs was 31% (n=1 131). Of these, 12% were experienced by patients with HIV and TB co-infection and 885 by patients with no co-infection. Higher rates of ADRs were found to be significantly associated with patients initiated on stavudine (aHR=9.4; 95% CI 7.4-12.1; p<0.001) and non-standardised regimens (aHR=6.6; 95% CI 4.5-9.8; p<0.001). Peripheral neuropathy and skin rash were the most common ADRs. Patients initiated on a CD4+ count <350 cells/mm3 (aHR=1.3; 95% CI 1.1-1.4, p<0.001) and cigarette smokers (aHR=1.4; 95% CI 1.1-1.7, p=0.015) were at higher risk of developing ADRs. Conclusion: Overall, results suggested a modest incidence of ADRs amongst HIV- and TB co-infected, with no significant association between ADRs and TB-coinfection. A pharmacovigilance surveillance system remains essential

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