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Abstract Background Malaria is a public health hazard globally, with Sub-Saharan Africa accounting for more than 90% of malaria deaths, primarily affecting children under the age of five. In Rwanda, malaria interventions include the availability of antimalarial medications, notably Artemisinin-based combination treatments (ACTs) and quick diagnostic test kits (RDTs). However, the availability of antimalarial medicines and its related inventory management at community level in Rwanda has yet to be identified. Methods The study was conducted using a descriptive cross-sectional research design. The study involved the Community Health Workers (CHWs) in Bugesera District, working as a team of one male-female pair called Binômes. CHWs provide Integrated Community Case Management (iCCM) and treatment of Malaria in the villages. The sample size was 295 and respondents were selected using convenient random sampling from 15 sectors of Bugesera District, each cell being represented. A structured research questionnaire was used to collect data. The questionnaires were filled by CHWs who were available for this study at the time of data collection. Collected data were exported to SPSS version 26 for coding and analysis. Results The CHWs reported to be actively involved in managing the antimalarial medicines inventory. Overall, 64.1% of CHWs indicated that the population could easily obtain antimalarial medicines from community health workers and 31.2% attested that people could also obtain antimalarial medicines from the health centers. Majority of respondents 78% confirmed that the CHWs had the appropriate storage conditions for antimalarial medicines, while the overall stock out recorded was 3.20%. Furthermore, CHWs described some challenges, including but not limited to, lack of appropriate or dependable transportation and inappropriate medicines storage. Transportation was reported as a critical barrier for accessing antimalarial medicines. The majority, 70,85% travel on foot while 25.4% reported that CHWs walk for a distance between 1 and 2 h for resupply of antimalarial medicines. Conclusion This study investigated the availability of antimalarial medicines and inventory management challenges at community level in Rwanda. Addressing these challenges will reduce the rate of stockout and increase the availability of antimalarial medicine at community level. Appropriate storage, and reduction of stock out rate, will serve to strengthen the current CHWs system, and provide critical guidance for the evolution of CHWs’ systems in Rwanda.

Amon Nsengimana,1 Emmanuel Biracyaza,2,3 Joyce Isimbi,4 Charles Uwambajimana,4 Jean Claude Hategekimana,4 Vedaste Kagisha,4 Domina Asingizwe,5,6 Jean Baptiste Nyandwi4,6 1US Agency for International Development Global Health Supply Chain Program, Procurement and Supply Chain Management, Kigali, Rwanda; 2School of Rehabilitation, Faculty of Medicine, Université de Montréal, Québec, Canada; 3Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal (CRIR), Montreal, Canada; 4Department of Pharmacy, University of Rwanda, Kigali, Rwanda; 5Department of Physiotherapy; University of Rwanda, Kigali, Rwanda; 6East African Community Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management, University of Rwanda, Kigali, RwandaCorrespondence: Amon Nsengimana, Email amonnsengimana@gmail.comPurpose: This study aimed to explore the request and dispensing of antimalarial medicines without a prescription in community pharmacies in Rwanda, as well as factors associated.Methods: We employed an embedded mixed-methods design that involved a convenience sample of 235 licensed community pharmacists between February and April 2022. To simultaneously collect qualitative and quantitative data, we used a self-administered questionnaire containing a combination of close and open-ended questions. Bivariate and multivariate regression analyses were performed to examine the relationship between dispensing antimalarial medicines without a prescription and the selected independent variables. Statistical significance was set at p< 0.05, and a 95% confidence interval was applied. The factors influencing the dispensing of antimalarial medicines without a prescription were analyzed using thematic content analysis as a qualitative analysis approach.Results: Most respondents (88.5%) were asked to dispense antimalarial medicines by clients without a prescription. More than half of them (54%) agreed, but 34.5% refused; instead, they referred clients to malaria diagnostic testing facilities. Those who had rapid diagnostic tests for malaria in stock (OR=2.08, 95% CI:1.1– 3.94), and thought that antimalarials were over-the-counter medicines (OR=7.03, 95% CI:2.01– 24.5) were more likely to dispense antimalarial medicines without prescriptions. The primary reasons reported by community pharmacists for dispensing antimalarial medicines without prescriptions included their prior knowledge of malaria diagnosis, client pressure, and fear of losing clients. However, non-adherence to negative results obtained from formal health facilities and long queues at these institutions have also been cited as additional factors driving clients to seek antimalarial medicines without prescriptions.Conclusion: Dispensing antimalarial medicines without prescriptions is a common practice in community pharmacies in Rwanda. The main factors contributing to this practice include lack of awareness regarding the classification of antimalarials as prescription medicines, the availability of malaria diagnostic tests, client pressure, and fear of losing clients.Keywords: request, antimalarial medicines, dispensing, community pharmacies, Rwanda

Abstract Background Malaria is the single largest cause of illness in Uganda. Since the year 2008, the Global Fund has rolled out several funding streams for malaria control in Uganda. Among these are mechanisms aimed at increasing the availability and affordability of artemisinin-based combination therapy (ACT). This paper examines the availability and affordability of first-line malaria treatment and diagnostics in the private sector, which is the preferred first point of contact for 61% of households in Uganda between 2007 and 2018. Methods Cross-sectional surveys were conducted between 2007 and 2018, based on a standardized World Health Organization/Health Action International (WHO/HAI) methodology adapted to assess availability, patient prices, and affordability of ACT medicines in private retail outlets. A minimum of 30 outlets were surveyed per year as prescribed by the standardized methodology co-developed by the WHO and Health Action International. Availability, patient prices, and affordability of malaria rapid diagnostic tests (RDTs) was also tracked from 2012 following the rollout of the test and treat policy in 2010. The median patient prices for the artemisinin-based combinations and RDTs was calculated in US dollars (USD). Affordability was assessed by computing the number of days’ wages the lowest-paid government worker (LPGW) had to pay to purchase a treatment course for acute malaria. Results Availability of artemether/lumefantrine (A/L), the first-line ACT medicine, increased from 85 to100% in the private sector facilities during the study period. However, there was low availability of diagnostic tests in private sector facilities ranging between 13% (2012) and 37% (2018). There was a large reduction in patient prices for an adult treatment course of A/L from USD 8.8 in 2007 to USD 1.1 in 2018, while the price of diagnostics remained mostly stagnant at USD 0.5. The affordability of ACT medicines and RDTs was below one day’s wages for LPGW. Conclusions Availability of ACT medicines in the private sector medicines retail outlets increased to 100% while the availability of diagnostics remained low. Although malaria treatment was affordable, the price of diagnostics remained stagnant and increased the cumulative cost of malaria management. Malaria stakeholders should consolidate the gains made and consider the inclusion of diagnostic kits in the subsidy programme.

Background: Malaria is the single largest cause of illness in Uganda. Since the year 2008, the Global Fund has rolled out several funding streams for malaria control in Uganda. Among these are mechanisms aimed at increasing the availability and affordability of artemisinin-based combination therapy (ACT). This paper examines the availability and affordability of first-line malaria treatment and diagnostics in the private sector, which is the preferred first point of contact for 61% of households in Uganda between 2007 and 2018. Methods: Cross-sectional surveys were conducted between 2007 and 2018, based on a standardized World Health Organization/Health Action International (WHO/HAI) methodology adapted to assess availability, patient prices, and affordability of ACT medicines in private retail outlets. A minimum of 30 outlets were surveyed per year as prescribed by the standardized methodology co-developed by the WHO and Health Action International. Availability, patient prices, and affordability of malaria rapid diagnostic tests (RDTs) was also tracked from 2012 following the rollout of the test and treat policy in 2010. The median patient prices for the artemisinin-based combinations and RDTs was calculated in US dollars (USD). Affordability was assessed by computing the number of days' wages the lowest-paid government worker (LPGW) had to pay to purchase a treatment course for acute malaria. Results: Availability of artemether/lumefantrine (A/L), the first-line ACT medicine, increased from 85 to100% in the private sector facilities during the study period. However, there was low availability of diagnostic tests in private sector facilities ranging between 13% (2012) and 37% (2018). There was a large reduction in patient prices for an adult treatment course of A/L from USD 8.8 in 2007 to USD 1.1 in 2018, while the price of diagnostics remained mostly stagnant at USD 0.5. The affordability of ACT medicines and RDTs was below one day's wages for LPGW. Conclusions: Availability of ACT medicines in the private sector medicines retail outlets increased to 100% while the availability of diagnostics remained low. Although malaria treatment was affordable, the price of diagnostics remained stagnant and increased the cumulative cost of malaria management. Malaria stakeholders should consolidate the gains made and consider the inclusion of diagnostic kits in the subsidy programme. [ABSTRACT FROM AUTHOR]

Abstract Background Assessing the quality of medicines in low-middle income countries (LMICs) relies primarily on human inspection and screening technologies, where available. Field studies and surveys have frequently utilized screening tests to analyse medicines sampled at the point of care, such as health care facilities and medicine outlets, to provide a snap shot of medicine quality in a specific geographical area. This review presents an overview of the screening tests typically employed in surveys to assess anti-malarial medicine quality, summarizes the analytical methods used, how findings have been reported and proposes a reporting template for future studies. Methods A systematic search of the peer-reviewed and grey literature available in the public domain (including national and multi-national medicine quality surveys) covering the period 1990–2016 was undertaken. Studies were included if they had used screening techniques to assess the quality of anti-malarial medicines. As no standardized set of guidelines for the methodology and reporting of medicine quality surveys exist, the included studies were assessed for their standard against a newly proposed list of criteria. Results The titles and abstracts of 4621 records were screened and only 39 were found to meet the eligibility criteria. These 39 studies utilized visual inspection, disintegration, colorimetry and Thin Layer Chromatography (TLC) either as components of the Global Pharma Health Fund (GPHF) MiniLab® or as individual tests. Overall, 30/39 studies reported employing confirmatory testing described in international pharmacopeia to verify the quality of anti-malarials post assessment by a screening test. The authors assigned scores for the 23 criteria for the standard of reporting of each study. Conclusions There is considerable heterogeneity in study design and inconsistency in reporting of field surveys of medicine quality. A lack of standardization in the design and reporting of studies of medicine quality increases the risk of bias and error, impacting on the generalizability and reliability of study results. The criteria proposed for reporting on the standard of studies in this review can be used in conjunction with existing medicine quality survey guidelines as a checklist for designing and reporting findings of studies. The review protocol has been registered with PROSPERO (CRD42015026782).

Medicines are meant to help people and treat their conditions and to promote general well-being of all members of the society. Unfortunately, this is being compromised by the distribution and sale of poor-quality medicines around the world, being a consequence of non-GMP manufacturing. In this study, the contamination of the outer primary packaging with active pharmaceutical ingredient (API, i.e. artemether) is investigated as a possible and objective, quantifiable marker for GMP-compliance. First, an analytical UPLC-MS method was developed and verified for artemether, with emphasis on the quantification in the lower concentration range. Second, a swabbing procedure for the outer surface of plastic bottles (powders for suspension) was developed, including a swabbing recovery of the API from the bottle surfaces. Finally, twenty antimalarial samples were investigated. All of them showed some degree of outer contamination; however, large differences in the amount of API contamination between the different samples was observed, ranging between 4 and 144 ng/cm2. A positive correlation was found between the amount of artemether on the packaging and the number of information elements missing on the packaging or leaflet, which was used as one of the tools to evaluate the GMP status of the manufacturer. Image 1 • The outer surface of antimalarial medicines contained API between 4 and 144 ng/cm2. • A positive correlation was seen between API amount and GMP-compliance status. • The primary packaging contamination can be further developed as a GMP-marker. [ABSTRACT FROM AUTHOR]

Abstract Falsified medicines represent a serious threat to public health. Among the different measures to effectively combat this scourge, analytical methods play a key role in their detection and removal from the market before they reach patients. The present study evaluates for the first time the potential of a benchtop low-field (LF) Nuclear Magnetic Resonance (NMR) spectrometer for uncovering drug falsification by focusing on the analysis of fifteen erectile dysfunction and nine antimalarial medicines, the most commonly reported falsified medicines in developed and developing countries respectively. After a simple and rapid sample preparation and ≈ 5 min of spectrum recording, LF 1H NMR allows to conclude on the quality of the medicine: presence or absence of the expected active pharmaceutical ingredient (API), presence of unexpected API, absence of any API. Some 2D experiments are also described but although conclusive they are hampered by the duration of the experiments. The LF 1H NMR assay, based on the internal standard method, is validated by the determination of its accuracy, repeatability, limits of detection (LOD) and quantification (LOQ), and by comparison of the data obtained on some medicines after 45 min of spectrum recording to those measured with high-field 1H NMR. Because of its saving capabilities (cost, space, user experience), LF 1H NMR spectroscopy might become a routine screening tool in laboratories in charge of detecting falsified medicines. Graphical abstract fx1 Highlights • Benchtop low-field (60 MHz) NMR was evaluated to uncover falsified medicines. • Qualitative 1H NMR spectra were obtained in 5 min. • Low-field 1H NMR assay, based on the internal standard method, was validated. [ABSTRACT FROM AUTHOR]

Background: Assessing the quality of medicines in low-middle income countries (LMICs) relies primarily on human inspection and screening technologies, where available. Field studies and surveys have frequently utilized screening tests to analyse medicines sampled at the point of care, such as health care facilities and medicine outlets, to provide a snap shot of medicine quality in a specific geographical area. This review presents an overview of the screening tests typically employed in surveys to assess anti-malarial medicine quality, summarizes the analytical methods used, how findings have been reported and proposes a reporting template for future studies. Methods: A systematic search of the peer-reviewed and grey literature available in the public domain (including national and multi-national medicine quality surveys) covering the period 1990–2016 was undertaken. Studies were included if they had used screening techniques to assess the quality of anti-malarial medicines. As no standardized set of guidelines for the methodology and reporting of medicine quality surveys exist, the included studies were assessed for their standard against a newly proposed list of criteria. Results: The titles and abstracts of 4621 records were screened and only 39 were found to meet the eligibility criteria. These 39 studies utilized visual inspection, disintegration, colorimetry and Thin Layer Chromatography (TLC) either as components of the Global Pharma Health Fund (GPHF) MiniLab ® or as individual tests. Overall, 30/39 studies reported employing confirmatory testing described in international pharmacopeia to verify the quality of anti-malarials post assessment by a screening test. The authors assigned scores for the 23 criteria for the standard of reporting of each study. Conclusions: There is considerable heterogeneity in study design and inconsistency in reporting of field surveys of medicine quality. A lack of standardization in the design and reporting of studies of medicine quality increases the risk of bias and error, impacting on the generalizability and reliability of study results. The criteria proposed for reporting on the standard of studies in this review can be used in conjunction with existing medicine quality survey guidelines as a checklist for designing and reporting findings of studies. The review protocol has been registered with PROSPERO (CRD42015026782). [ABSTRACT FROM AUTHOR]

Background: Prompt and effective treatment of malaria in pregnancy in accordance with recommended guidelines is essential to help prevent adverse events among pregnant mothers and the foetus.Aim: The aim of this study was to assess current prescribing of antimalarial medicines in pregnancy against policy guidelines in south east Nigeria to provide future guidance.Methods: A review of prescription records of pregnant women treated for malaria over a 6-month period between August 2013 and January 2014 was carried out to assess the prescribing patterns for both the prevention and treatment of malaria in each trimester and analyzed for conformity to recommended guidelines.Results: Among 859 antenatal records reviewed, the majority (83.2%) were in the second and third trimesters. Artemisinin-based combination therapies (40.9%) and sulfadoxine-pyrimethamine (37.5%) were the most prescribed antimalarial medicines for both treatment and prophylaxis (prevention), respectively, in all trimesters. Overall, 68.5% of the prescriptions conformed to guideline recommendations, with the prescriptions for non-recommended drugs occurring most often in the first trimester. In the second and three trimesters, up to 79.9% of pregnant women received appropriate medicines for both treatment and prevention of malaria, with artemether-lumefantrine the most prescribed regimen.Conclusion: Current practice indicates greater conformity with guidelines particularly in the second and three trimesters vs previous studies. However, there are still concerns with prescribing practices in the first trimester, especially in private health facilities. This needs addressing. [ABSTRACT FROM AUTHOR]