Quality, availability and storage conditions of oxytocin and misoprostol in Malawi.

BACKGROUND: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low- and middle-income countries (LMICs). Oxytocin and misoprostol are used for the prevention and treatment of PPH. However, both medicines are chemically unstable and sensitive to environmental conditions. Previous studies reported a high prevalence of substandard oxytocin and misoprostol preparations in LMICs. METHODS: In randomly selected health facilities of four districts of Malawi, the availability of oxytocin and misoprostol was determined, and the knowledge of health workers on storage requirements and use of oxytocics was assessed. Temperature loggers were used to record the storage temperature of oxytocics. Samples of oxytocin injections and misoprostol tablets were collected from the health facilities and from wholesalers. Oxytocin samples were analysed for identity, assay (= quantity of oxytocin) and for pH value according to United States Pharmacopeia 40. Misoprostol samples were analysed for identity, assay, dissolution and related substances according to the International Pharmacopeia 2017. RESULTS: All visited hospitals and health centers had oxytocin available. At non-refrigerated storage sites, the recorded mean kinetic temperature exceeded the oxytocic's storage temperature stated on the labels in 42% of the sites. At refrigerated storage sites, the required temperature of 2-8 °C was exceeded in 33% of the sites. Out of 65 oxytocin samples, 7 (11%) showed moderate deviations from specification, containing 82.2-86.8% of the declared amount of oxytocin. Out of 30 misoprostol samples, 5 (17%) showed extreme deviations, containing only 12.7-30.2% of the declared amount. The extremely substandard misoprostol was reported to the national authorities and to WHO, leading to an immediate recall of the respective brand in Malawi. The UK-based distributor of this brand closed its business shortly thereafter. CONCLUSION: Availability of oxytocin was excellent in Malawi, and its quality was better than reported in previous studies in other LMICs. However, storage conditions at the health facilities often did not meet the requirements. Extremely substandard misoprostol tablets were found, representing a serious risk to maternal health. This shows the need for continued efforts for quality assurance in medicine procurement and registration, as well as for post-marketing surveillance.

"The number of clients is increasing but the supplies are reducing": provider strategies for responding to chronic antiretroviral (ARV) medicines stock-outs in resource-limited settings: a qualitative study from Uganda.

BACKGROUND: Despite the increasing frequency of ARV medicines stock-outs in Sub-Saharan Africa, there is little research inquiring into the mitigation strategies devised by frontline health facilities. Many previous studies have focused on 'upstream' or national-level drivers of ARVs stock-outs with less empirical attention devoted 'down-stream' or at the facility-level. The objective of this study was to examine the strategies devised by health facilities in Uganda to respond to the chronic stock-outs of ARVs. METHODS: This was a qualitative research design nested within a larger mixed-methods study. We purposively selected 16 health facilities from across Uganda (to achieve diversity with regard to; level of care (primary/ tertiary), setting (rural/urban) and geographic sub-region (northern/ central/western). We conducted 76 Semi-structured interviews with ART clinic managers, clinicians and pharmacists in the selected health facilities supplemented by on-site observations and documentary reviews. Data were analyzed by coding and thematic analyses. RESULTS: Participants reported that facility-level contributors to stock-outs include untimely orders of drugs from suppliers and inaccurate quantification of ARV medicine needs due to a paucity of ART program data. Internal stock management solutions for mitigating stock-outs which emerged include the substitution of ARV medicines which were out of stock, overstocking selected medicines and the use of recently expired drugs. The external solutions for mitigating stock-outs which were identified include 'borrowing' of ARVs from peer-providers, re-distributing stock across regions and upward referrals of patients. Systemic drivers of stock-outs were identified. These include the supply of drugs with a short shelf life, oversupply and undersupply of ARV medicines and migration pressures on the available ARVs stock at case-study facilities. CONCLUSION: Health facilities devised internal stock management strategies and relied on peer-provider networks for ARV medicines during stock-out events. Our study underscores the importance of devising interventions aimed at improving Uganda's medicines supply chain systems in the quest to reduce the frequency of ARV medicines stock-outs at the front-line level of service delivery. Further research is recommended on the effect of substituting ARV medicines on patient outcomes.

Use of thin-layer chromatography to detect counterfeit sulfadoxine/pyrimethamine tablets with the wrong active ingredient in Malawi.

BACKGROUND: Substandard and falsified anti-malarial medicines pose a serious threat to public health, especially in low-income countries. Appropriate technologies for drug quality analysis in resource-limited settings are important for the surveillance of the formal and informal drug market. The feasibility of thin-layer chromatography (TLC) with different solvent systems was tested using the GPHF Minilab in a study of the quality of sulfadoxine/pyrimethamine tablets in Malawi. METHODS: Twenty eight samples of sulfadoxine/pyrimethamine tablets were collected from randomly selected health facilities of four districts of southern Malawi. A mystery shopper approach was used when collecting samples from illegal street vendors, and an overt approach for the other facilities. Samples were subjected to visual inspection, disintegration testing and TLC analysis. 10 samples were further investigated according to the methods of the US Pharmacopeia using high performance liquid chromatography (HPLC). RESULTS: One sample was found to be falsified, containing a mixture of paracetamol tablets and co-trimoxazole tablets. These had been repackaged into paper strip packs labelled as a brand of sulfadoxine/pyrimethamine. TLC with different solvent systems readily proved that these tablets did not comply with their declaration, and provided strong evidence for the active pharmaceutical ingredients which were actually contained. Full pharmacopeial analysis by HPLC confirmed the results suggested by TLC for this sample, and showed two further samples to be of substandard quality. CONCLUSIONS: Due to the absence of the declared anti-malarial ingredients and due to the presence of other pharmaceutical ingredients, the identified falsified medicine represents a serious health risk for the population. Thin-layer chromatography (TLC) using different solvent systems proved to be a powerful method for the identification of this type of counterfeiting, presenting a simple and affordable technology for use in resource-limited settings.

Availability, pricing, and affordability of essential medicines for pediatric population in Malawi.

Objective: Lack of access to essential medicines negatively impacts on the quality of healthcare delivery and increases morbidity and mortality, especially to the vulnerable pediatric population. We assessed the availability, pricing, and affordability of pediatric formulations in Malawi. Methodology: The study was conducted in 76 health facilities (public, faith-based and private pharmacies, and clinics) from the northern and southern regions of Malawi from March to May 2023. We adapted the WHO/HAI method for the assessment of both availability and pricing of medicines. Data on availability were collected from stock card records using a WHO/HAI template and medicine prices were provided by the pharmacy personnel who were managing the facilities. Availability of medicines was calculated as the percentage of facilities which had a stock of the respective medicine at the time of data collection while medicine prices was assessed by calculating the median prices of each medicine. To assess the affordability of the medicines, we calculated the number of days it takes for a person who is receiving the government-set minimum wage to work to pay for a treatment course of common indications. The study was approved by the KUHES ethics committee under the numbers U.12/22/3900 and U.12/22/3903. Results and conclusion: The overall availability of pediatric medicines was 38.1% for public health facilities, 53.7% for private retail pharmacies and drug stores, 49.5% for private clinics and 48.3% for Christian Health Association of Malawi (CHAM) facilities. We found the illegal availability of prescription-only medicines of up to 54% in medicine stores. Medicine median prices were higher in the private clinics followed by retail pharmacies and drugs stores. CHAM had the lowest median prices for medicines of all the sectors. More than 50% of medicines were found to be affordable as less than a day's wage was required to purchase the treatment. We found poor availability of pediatric formulation among public, CHAM, and private sectors in Malawi. This may affect the quality of care among pediatric patients and therefore contribute to morbidity and mortality in Malawi. The supply of medicines and health commodities needs to consider needs of special populations such as children to achieve universal health coverage.

Correction: Experiences of doctoral students enrolled in a research fellowship program to support doctoral training in Africa (2014 to 2018): The Consortium for Advanced Research Training in Africa odyssey.

[This corrects the article DOI: 10.1371/journal.pone.0252863.].

Association between HIV and treatment-resistant hypertension in Malawian adults: a protocol for a case-control study.

INTRODUCTION: Treatment-resistant hypertension (RH), defined as uncontrolled blood pressure (≥140/90 mm Hg) despite treatment with ≥3 medications of different classes (including diuretics) at optimal doses, is associated with poor prognosis and an elevated risk of end-organ damage. In areas where HIV is endemic, such as sub-Saharan Africa, the risk of hypertension is high in people living with HIV. It remains unknown if HIV infection further increases the risk of RH. This study seeks to determine the association between HIV and RH as well as investigate other factors associated with RH in hypertensive Malawian adults. METHODS AND ANALYSIS: A case-control study will be conducted among adult hypertensive patients attending a clinic at a referral hospital in Malawi. The cases will be hypertensive patients with a confirmed diagnosis of RH. For each case, two controls (hypertensive patients without RH), frequency matched for age group and sex, will be selected from among hospital clients attending the same hypertension clinic as the case. In both groups, HIV status will be ascertained. Additionally, information on other potential risk factors of RH, such as chronic kidney disease, obesity, hypercholesteraemia, diabetes, smoking, alcohol use, antiretroviral therapy regimen and duration, will be collected in both cases and controls. For each of the potential risk factors, ORs will be calculated to quantify the strength of their association with RH. In a multivariate analysis, conditional logistic regression will be used to assess the independent association between HIV and RH as well as the influence of the other potential drivers of RH. ETHICS AND DISSEMINATION: This protocol has been approved by the College of Medicine Research Ethics Committee (COMREC) in Malawi (P.05/22/3637). Findings from this study will be disseminated through a peer-reviewed publication in an open-access international journal. Furthermore, anonymised data will be available on request from the authors.

Effect of antibiotic medicines availability on adherence to standard treatment guidelines among hospitalized adult patients in southern Malawi.

BACKGROUND: Antibiotic resistance is a global public health problem. High and inappropriate use of antibiotic therapy exacerbate the risk of antibiotic resistance. We assessed the effect of availability of antibiotic medicines on adherence to standard treatment guidelines among hospitalized adult patients in Southern Malawi. METHODS: A cross-sectional study was done to assess the availability of 16 antibiotics among the first-line recommended treatments for common bacterial infections in Malawi. Data for up to six-month duration was extracted from stock card records in Machinga and Nsanje District Hospitals and Zomba Central Hospital. This was complemented by a retrospective review of 322 patient management files from medical wards to assess adherence to the Malawi Standard Treatment Guidelines (MSTG). Investigators abstracted data such as patient demographics, diagnoses, and prescribed therapy using a data collection form that resulted in analyzing 304 patient files. Data was entered into Microsoft excel and analyzed using STATA 14.1. Point availability, stock-out duration and adherence to treatment guidelines were presented in terms of frequencies and percentages. Chi-square test or Fisher's exact test was applied to assess the association between variables and adherence to treatment guidelines. RESULTS: Point availability of antibiotics was 81.5%, 87.7%, and 42.8% for Zomba Central, Machinga and Nsanje District Hospitals respectively. Over a period of six months, 12.5% of antibiotic medicines were stocked out for at least one day at Zomba (Median stock out days = 0, (IQR 0-0 days), while 64.3% were stocked out at Machinga (Median stock out days = 21, IQR 0-31 days) and 85.7% were stocked out at Nsanje District Hospital (Median stock out days = 66.5, IQR 18-113 days). Overall, adherence to MSTG was 79.6%, (95% CI, 73.3-84.9%). By facilities, adherence to guidelines at Zomba Central Hospital was 95.9% (95% CI, 89.7-98.9%) while at Nsanje and Machinga District Hospitals was 73.2% (95% CI, 59.7-84.2%) and 54.2% (95% CI, 39.2-68.6%) respectively. Adherence to treatment guidelines was associated with health facility, presence of laboratory test results, antibiotic spectrum, and WHO-AWaRe category of the medicine, p<0.005. Adherence was lower for antibiotics that were stocked out than antibiotics that were not stocked out during the study period (63.8%, 95% CI 48.5-77.3% vs 84.4%, 95% CI 77.7-89.8%), p< 0.002. CONCLUSION: We found unstable availability of antibiotic medicines in hospitals which might contribute to the sub-optimal adherence to standard treatment guidelines. This is a setback to efforts aimed at curbing antibiotic resistance in Malawi.

Temperature variations in pharmaceutical storage facilities and knowledge, attitudes, and practices of personnel on proper storage conditions for medicines in southern Malawi.

Objective: We assessed the temperature variations in pharmacies and medicine storage areas in southern Malawi and conducted a knowledge, attitude and practices survey for personnel who manage medicine stores in various health facilities. Methods: This was a longitudinal study design that used installed Tempmate® thermometers in 27 selected health facilities to record temperatures every 15 min for a period of 9 months. In addition, a questionnaire was used to assess the knowledge, attitude, and practices regarding good pharmaceutical storage. Observations were also made on the storage structures of the facilities and compared with the mean kinetic temperature. Results: Storage temperature ranged from 13.8°C to 42°C with mean kinetic temperature (MKT) being 25.3°C (95% CI 24.4-26.2°C). Mean temperature for public facilities was lower (23.8°C) than the faith-based facilities (25.2°C) and private facilities (26.6°C). In terms of level of health care, lower temperatures were recorded in facilities offering tertiary level of care as compared to secondary and primary care facilities, p < 0.001. For the type of storage facilities, storage-in-a-box unit (SIAB) presented lower temperatures than ordinary storage areas (non-SIAB), p < 0.001. Majority of health workers (69%) had good knowledge on proper storage conditions. Air conditioners and thermometers were available in 88.4 and 76.9% of the facilities, respectively. However, few facilities utilized the air conditioners due to electricity problems. About 46.15% of the participants were able to correctly record temperatures (at least twice a day) for the storage facilities, 23.07% did not properly record while 30.77% of the personnel did not keep temperature records at all. Limited storage space was among the challenges that facilities encounter to maintain proper storage conditions. Conclusion: Despite having the necessary knowledge on proper storage conditions, the pharmacy personnel failed to adhere to good pharmaceutical storage practices due to resource limitations. There is a need for stakeholder interventions such as increasing budget allocation to address the challenges faced by the health facilities.

Current rates of purchasing of antibiotics without a prescription across sub-Saharan Africa; rationale and potential programmes to reduce inappropriate dispensing and resistance.

INTRODUCTION: Antimicrobial resistance (AMR) is a global concern. Currently, the greatest mortality due to AMR is in Africa. A key driver continues to be high levels of dispensing of antibiotics without a prescription. AREAS COVERED: A need to document current rates of dispensing, their rationale and potential ways forward including antimicrobial stewardship programmes (ASPs). A narrative review was undertaken. The highest rates of antibiotic purchasing were in Eritrea (up to 89.2% of antibiotics dispensed), Ethiopia (up to 87.9%), Nigeria (up to 86.5%), Tanzania (up to 92.3%) and Zambia (up to 100% of pharmacies dispensing antibiotics without a prescription). However, considerable variation was seen with no dispensing in a minority of countries and situations. Key drivers of self-purchasing included high co-payment levels for physician consultations and antibiotic costs, travel costs, convenience of pharmacies, patient requests, limited knowledge of antibiotics and AMR and weak enforcement. ASPs have been introduced in some African countries along with quality targets to reduce inappropriate dispensing, centering on educating pharmacists and patients. EXPERT OPINION: ASP activities need accelerating among community pharmacies alongside quality targets, with greater monitoring of pharmacists' activities to reduce inappropriate dispensing. Such activities, alongside educating patients and healthcare professionals, should enhance appropriate dispensing of antibiotics and reduce AMR.

Determinants of clinician and patient to prescription of antimicrobials: Case of Mulanje, Southern Malawi.

BACKGROUND: Antimicrobial resistance is an emerging problem in low- and middle-income countries. The problem is exacerbated by inappropriate prescription of antimicrobials. Factors that lead to overuse or inappropriate prescription of antimicrobials by the cadre of medical assistants, clinical technicians and clinical officers have received limited attention. This study investigated factors that influence prescription behaviours of antimicrobials among clinical officers in various health facilities in Mulanje district, Southern Malawi. METHODS: Qualitative study design exploring determinants of antimicrobial prescription from May to October, 2019, was used. In-depth interviews (n = 18) and focus group discussions (n = 2) were conducted with medical assistant (MA), clinical technicians and clinical officers (CO) from four health facilities in Mulanje district. COs are licensed medical practitioners with an initial three-year training and one-year internship while MAs are licensed medical practitioners with initial two-year training and one year internship. Purposive sampling was done to arrive at a sample size of 30 health cadres. RESULTS: Participants pointed out that patient preferences, beliefs and clinicians' inadequate education on this issue were among the factors that contribute to inappropriate antimicrobial prescription. 75% of clinicians showed lack of knowledge on the definition of antibiotic and antimicrobial resistance. CONCLUSION: Inappropriate use of antimicrobials is facilitated by prescription decisions made by clinicians who are greatly influenced by their patients. Interventions aimed at improving antimicrobial prescription should target both clinicians and patients.

Burden of and factors associated with poor quality antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi.

OBJECTIVE: To assess the prevalence and factors associated with substandard and falsified (SF) medicines among antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi. METHODS: We conducted a cross-sectional study in 23 public, faith-based and private health facilities in Zomba, Machinga and Nsanje districts. We analyzed oral medicine samples of commonly used medicines among antibiotics, antimalarial, antihypertensive and antidiabetics in accordance with Malawi Essential Medicines List and local treatment guidelines. These medicines were subjected to visual inspection for any defects and screening for the content of active pharmaceutical ingredient and disintegration of dosage units. Samples that failed during screening and at least 10% of those that passed were subjected to pharmacopeia assay and dissolution test for confirmation. We used thin layer chromatography and disintegration test methods provided in the Global Pharma Health Fund minilab® for the screening purposes. We conducted confirmatory test using High-Performance Liquid Chromatography (HPLC) or ultra-violet/visible spectrophotometer and dissolution. RESULTS: Of the 293 medicine samples collected, 14.3% were SF medicines. Among the SF medicines were 12.5% of Amlodipine (1/8), 19.2% of Amoxicillin (5/26), 72.2% of Atenolol (8/11), 21.2% of Ciprofloxacin (7/33), 14.3% of Enalapril (1/7), 44.4% of Flucloxacillin (4/9), and 35.7% of sulfadoxine/ pyrimethamine (10/28). Medicine quality was associated with therapeutic medicine class, stated origin of manufacturer, primary packaging material and geographical location. Antimalarial and antidiabetic medicines were of better quality as compared to antibiotics, odds ratio OR 4.2 (95% CI 1.7-9.49), p < 0.002 and OR 5.6 (95% CI 1.21-26.09), p < 0.028 respectively. In terms of stated country of origin, the prevalence of SF medicines was 30% (15/50), 33% (9/27), 26.7% (4/15) and 6.6% (8/122) for medicines stated to be manufactured in Malawi, China, Kenya and India respectively. CONCLUSION: This study presents the first findings on the assessment of quality of medicines since the establishment of the national pharmacovigilance center in 2019 in Malawi. It is revealed that the problem of SF medicines is not improving and hence the need for further strengthening of quality assurance systems in Malawi.

A Malawian pharmaceutical response to the COVID-19 Pandemic.

The COVID-19 pandemic has elicited swift and innovative responses due to the severity of the outbreak. Higher education institutions worldwide with pharmacy programs have identified vital gaps in COVID-19 care and has undertaken proactive steps to aid in the fight against the coronavirus. In Malawi, the Kamuzu University of Health Science's Department of Pharmacy initiated the production of a modified formulation of the World Health Organization's (WHO) recommended hand sanitizer. This manufacturing venture involved mobilizing the pharmacy faculty, identifying gaps in supplies and equipment, and utilizing evidenced-based information to create a high-quality sanitation product, which passed the requirements as tested by the Malawi Bureau of Standards. The department of pharmacy is expanding their distribution of the product to meet the needs of frontline healthcare workers and vulnerable populations. With historical issues of accessing care in Malawi and with COVID-19's spread among healthcare workers, this hand sanitizer venture is vital in the public healthcare's system response. The department of pharmacy will continue to lead the pharmacy profession in Malawi to provide targeted interventions in this unprecedented time.

Tackling antimicrobial resistance across sub-Saharan Africa: current challenges and implications for the future.

INTRODUCTION: Antimicrobial resistance (AMR) is a concern as this increases morbidity, mortality, and costs, with sub-Saharan Africa having the highest rates globally. Concerns with rising AMR have resulted in international, Pan-African, and country activities including the development of national action plans (NAPs). However, there is variable implementation across Africa with key challenges persisting. AREAS COVERED: Consequently, there is an urgent need to document current NAP activities and challenges across sub-Saharan Africa to provide future guidance. This builds on a narrative review of the literature. EXPERT OPINION: All surveyed sub-Saharan African countries have developed their NAPs; however, there is variable implementation. Countries including Botswana and Namibia are yet to officially launch their NAPs with Eswatini only recently launching its NAP. Cameroon is further ahead with its NAP than these countries; though there are concerns with implementation. South Africa appears to have made the greatest strides with implementing its NAP including regular monitoring of activities and instigation of antimicrobial stewardship programs. Key challenges remain across Africa. These include available personnel, expertise, capacity, and resources to undertake agreed NAP activities including active surveillance, lack of focal points to drive NAPs, and competing demands and priorities including among donors. These challenges are being addressed, with further co-ordinated efforts needed to reduce AMR.

Coronavirus Disease 2019 (COVID-19) Pandemic across Africa: Current Status of Vaccinations and Implications for the Future.

The introduction of effective vaccines in December 2020 marked a significant step forward in the global response to COVID-19. Given concerns with access, acceptability, and hesitancy across Africa, there is a need to describe the current status of vaccine uptake in the continent. An exploratory study was undertaken to investigate these aspects, current challenges, and lessons learnt across Africa to provide future direction. Senior personnel across 14 African countries completed a self-administered questionnaire, with a descriptive analysis of the data. Vaccine roll-out commenced in March 2021 in most countries. COVID-19 vaccination coverage varied from low in Cameroon and Tanzania and up to 39.85% full coverage in Botswana at the end of 2021; that is, all doses advocated by initial protocols versus the total population, with rates increasing to 58.4% in Botswana by the end of June 2022. The greatest increase in people being fully vaccinated was observed in Uganda (20.4% increase), Botswana (18.5% increase), and Zambia (17.9% increase). Most vaccines were obtained through WHO-COVAX agreements. Initially, vaccination was prioritised for healthcare workers (HCWs), the elderly, adults with co-morbidities, and other at-risk groups, with countries now commencing vaccination among children and administering booster doses. Challenges included irregular supply and considerable hesitancy arising from misinformation fuelled by social media activities. Overall, there was fair to reasonable access to vaccination across countries, enhanced by government initiatives. Vaccine hesitancy must be addressed with context-specific interventions, including proactive programmes among HCWs, medical journalists, and the public.

Experiences of doctoral students enrolled in a research fellowship program to support doctoral training in Africa (2014 to 2018): The Consortium for Advanced Research Training in Africa odyssey.

BACKGROUND: The Consortium for Advanced Research Training in Africa (CARTA) aims to transform higher education in Africa. One of its main thrusts is supporting promising university faculty (fellows) to obtain high quality doctoral training. CARTA offers fellows robust support which includes funding of their attendance at Joint Advanced Seminars (JASes) throughout the doctoral training period. An evaluation is critical in improving program outcomes. In this study; we, CARTA fellows who attended the fourth JAS in 2018, appraised the CARTA program from our perspective, specifically focusing on the organization of the program and its influence on the fellows' individual and institutional development. METHODS: Exploratory Qualitative Study Design was used and data was obtained from three focus group discussions among the fellows in March 2018. The data were analyzed using thematic approach within the framework of good practice elements in doctoral training-Formal Research Training, Activities Driven by Doctoral Candidates, Career Development as well as Concepts and Structures. RESULTS: In all, 21 fellows from six African countries participated and all had been in the CARTA program for at least three years. The fellowship has increased fellows research skills and expanded our research capacities. This tremendously improved the quality of our doctoral research and it was also evident in our research outputs, including the number of peer-reviewed publications. The CARTA experience inculcated a multidisciplinary approach to our research and enabled significant improvement in our organizational, teaching, and leadership skills. All these were achieved through the well-organized structures of CARTA and these have transformed us to change agents who are already taking on research and administrative responsibilities in our various home institutions. Unfortunately, during the long break between the second and the third JAS, there was a gap in communication between CARTA and her fellows, which resulted in some transient loss of focus by a few fellows. CONCLUSION: The CARTA model which builds the research capacity of doctoral fellows through robust support, including intermittent strategic Joint Advanced Seminars has had effective and transformative impacts on our doctoral odyssey. However, there is a need to maintain the momentum through continuous communication between CARTA and the fellows all through this journey.

Strategies to Improve Antimicrobial Utilization with a Special Focus on Developing Countries.

Antimicrobial resistance (AMR) is a high priority across countries as it increases morbidity, mortality and costs. Concerns with AMR have resulted in multiple initiatives internationally, nationally and regionally to enhance appropriate antibiotic utilization across sectors to reduce AMR, with the overuse of antibiotics exacerbated by the COVID-19 pandemic. Effectively tackling AMR is crucial for all countries. Principally a narrative review of ongoing activities across sectors was undertaken to improve antimicrobial use and address issues with vaccines including COVID-19. Point prevalence surveys have been successful in hospitals to identify areas for quality improvement programs, principally centering on antimicrobial stewardship programs. These include reducing prolonged antibiotic use to prevent surgical site infections. Multiple activities centering on education have been successful in reducing inappropriate prescribing and dispensing of antimicrobials in ambulatory care for essentially viral infections such as acute respiratory infections. It is imperative to develop new quality indicators for ambulatory care given current concerns, and instigate programs with clear public health messaging to reduce misinformation, essential for pandemics. Regular access to effective treatments is needed to reduce resistance to treatments for HIV, malaria and tuberculosis. Key stakeholder groups can instigate multiple initiatives to reduce AMR. These need to be followed up.

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.

Stability of misoprostol tablets collected in Malawi and Rwanda: Importance of intact primary packaging.

Misoprostol is listed in the WHO essential medicines list and can be used for induction of labour, for prevention and treatment of post-partum haemorrhage, and for abortions. The compound is unstable, and substandard misoprostol preparations have been detected in low- and middle-income countries. We now investigated the stability of misoprostol tablets according to the international guidelines for stability testing of pharmaceutical products. Three brands (four batches) of misoprostol tablets were collected in Malawi and Rwanda: the originator product, a WHO-prequalified product, and a generic product without WHO prequalification. A further batch of the originator product was collected in Germany. To investigate the effect of damage to the primary packaging, additional blister strips of one sample were intentionally damaged with a needle and investigated in parallel. Samples were placed in stability chambers for six months at 40°C/75% relative humidity (RH) and at 25°C/60% RH. After 0, 1, 2, 3 and 6 months, misoprostol content was determined according to the International Pharmacopeia. At 40°C/75% RH, all samples showed a decline of misoprostol content, but four of the batches still remained within the pharmacopeial specifications, while one of the two batches of the generic product without WHO-prequalification showed a final content of 86.2% which is out of specifications. Damage to the primary packaging greatly decreased stability, resulting in a final content of only 48.2% of the declared misoprostol amount. At 25°C/60% RH all samples remained in specifications for six months, even the sample with the damaged blister. Dissolution of misoprostol remained in specifications of the pharmacopoeia for six months for all batches, except for the sample with damaged blisters stored at 40°C/75% RH. This study confirms that the stability of misoprostol tablets must be ensured by intact, good-quality primary packaging. Careful supplier qualification is required in the procurement process.

Stability of Oxytocin Preparations in Malawi and Rwanda: Stabilizing Effect of Chlorobutanol.

Oxytocin is used for the prevention and treatment of postpartum hemorrhage, the leading cause of maternal mortality in low- and middle-income countries. Because of the high instability of oxytocin, most products are labeled for storage at 2-8°C. Some other products are on the market which are labeled for non-refrigerated storage, but independent evaluations of their stability hardly exist. In the present study, seven brands (nine batches) of oxytocin were purchased from wholesalers and medical stores in Malawi and Rwanda and investigated by accelerated stability testing according to the ICH/WHO guidelines. Two oxytocin brands approved by a stringent regulatory authority (SRA) or by the WHO Prequalification of Medicines program and purchased in Europe were used as comparison. All investigated brands which were either produced in countries with SRAs, or were WHO-prequalified products, were labeled for storage at 2-8°C, and all of them passed stability testing with very good results. Even exposure to 25°C or 30°C for several months hardly affected their oxytocin content. However, two other investigated brands were labeled for non-refrigerated storage, and both of them had been produced in countries without SRAs. These two preparations showed not higher but lower stability than the brands labeled for storage at 2-8°C, and, for both of them, noncompliance with pharmacopoeial specifications was found after accelerated stability testing. At 40°C, and in forced degradation studies at 80°C, chlorobutanol showed a remarkable stabilizing effect on oxytocin, which may deserve further investigation. The results of the present study support the policy "Buy Quality Oxytocin, Keep It Cool."

Rapid Assessment of the Potential Paucity and Price Increases for Suggested Medicines and Protection Equipment for COVID-19 Across Developing Countries With a Particular Focus on Africa and the Implications.

Background: Countries across Africa and Asia have introduced a variety of measures to prevent and treat COVID-19 with medicines and personal protective equipment (PPE). However, there has been considerable controversy surrounding some treatments including hydroxychloroquine where the initial hype and misinformation led to shortages, price rises and suicides. Price rises and shortages were also seen for PPE. Such activities can have catastrophic consequences especially in countries with high co-payment levels. Consequently, there is a need to investigate this further. Objective: Assess changes in utilisation, prices, and shortages of pertinent medicines and PPE among African and Asian countries since the start of pandemic. Our approach: Data gathering among community pharmacists to assess changes in patterns from the beginning of March until principally the end of May 2020. In addition, suggestions on ways to reduce misinformation. Results: One hundred and thirty one pharmacists took part building on the earlier studies across Asia. There were increases in the utilisation of principally antimalarials (hydroxychloroquine) and antibiotics (azithromycin) especially in Nigeria and Ghana. There were limited changes in Namibia and Vietnam reflecting current initiatives to reduce inappropriate prescribing and dispensing of antimicrobials. Encouragingly, there was increased use of vitamins/immune boosters and PPE across the countries where documented. In addition, generally limited change in the utilisation of herbal medicines. However, shortages have resulted in appreciable price increases in some countries although moderated in others through government initiatives. Suggestions in Namibia going forward included better planning and educating patients. Conclusion: Encouraging to see increases in the utilisation of vitamins/immune boosters and PPE. However, concerns with increased utilisation of antimicrobials needs addressing alongside misinformation, unintended consequences from the pandemic and any appreciable price rises. Community pharmacists and patient organisations can play key roles in providing evidence-based advice, helping moderate prices through improved stock management, and helping address unintended consequences of the pandemic.