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Objective. The rational use of medicines offers a cost-saving strategy to maximize therapeutic outcomes for developing and developed countries. The aim of this study was to evaluate the rational use of medicines for selected noncommunicable diseases (NCDs) at three pharmacies at public hospitals in Jamaica using the World Health Organization’s (WHO’s) prescribing indicators. Methods. In this retrospective cross-sectional study, prescriptions for adult outpatients containing at least one medicine for cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease or asthma that were filled between January and July 2019 were reviewed using WHO’s prescribing indicators for the rational use of medicines. Data were analyzed and expressed as descriptive and inferential statistics. For all analyses conducted, significance was determined at P < 0.05. Results. A total of 1 500 prescriptions covering 5 979 medicines were reviewed; prescriptions were mostly written for female patients aged 42–60 years. Polypharmacy was observed in 35.6% (534) of prescriptions, and there was an average of 4 medicines per prescription, with a maximum of 17. Most of the prescriptions at each site were filled, with the main reason for not dispensing a medicine being that it was out of stock. Generic prescribing was high for all sites, accounting for more than 95% (5 722) of prescribed medicines. There was full compliance with prescribing according to the WHO Model List of Essential Medicines at two of the sites, but it was just off the target at Site 1, by 1.4%. Conclusions. The WHO guidelines for the rational use of medicines were followed with respect to the proportion of medicines prescribed from the WHO Model List and the proportion of antibiotics prescribed. The number of medicines per prescription and the proportion of medicines prescribed by generic name did not meet the WHO criteria. However, prescribing was aligned with treatment guidelines for the selected NCDs.

BackgroundChina has seen a significantly increased prevalence of chronic obstructive pulmonary disease (COPD) recently. But primary care institutions, the main "battlefield" for containing COPD, have shown relatively weak capabilities for the diagnosis and treatment of disease. As there are relatively few large-scale investigations and studies on medicines and diagnostic devices for COPD in primary care, we conducted this study to further understand the weaknesses of current COPD containment in primary care, by which the gap in related research may be made up.ObjectiveTo understand the allocation and availability rate of essential medicines for COPD, and availability rate of spirometer as well as the implementation of pulmonary function tests in primary care.MethodsFrom February to March 2021, a multi-stage cluster sampling was adopted to select 8 176 community (township) health centers from 31 provinces of China to attend a survey. The rates of availability and allocation of each of the 16 essential medicines for COPD in the 2018 National Essential Medicines List were calculated to estimate the categories and number of these medicines in primary care institutions. The rate of availability of spirometer in these institutions was estimated. And the rate of implementation of pulmonary function tests in these institutions was estimated.ResultsAltogether, 7 458 (91.22%) institutions who gave effective responses to the survey were included for analysis, including 5 901 (79.12%) township health centers, and 1 557 (20.88%) community health centers. Among the 16 essential medicines for COPD, less than 8 were available in 6 538 (87.66%) institutions, at least 1 inhaled antiasthmatic medicines were available in 4 992 (66.00%) institutions, and long-acting inhaled antiasthmatic medicines were available in 814 (10.91%) institutions. The average availability rate of 16 essential medicines for COPD was 33.30%. The highest ranked three medicines in terms of availability rate were ambroxol〔85.28% (6 360/7 458) 〕, aminophylline〔81.17% (6 054/7 458) 〕 and compound licorice〔74.48% (5 555/7 458) 〕. And the relatively low-ranked three were fluticasone propionate 〔4.89% (365/7 458) 〕, tiotropium bromide〔6.25% (466/7 458) 〕, budesonide forterol〔8.61% (642/7 458) 〕. The average availability rate of 6 inhaled antiasthmatic medicines in community health centers was 28.31%, and that in township health centers was 4.81%. The average availability rate of 2 long-acting inhaled antiasthmatic medicines in community health centers was 16.18%, and that in township health centers was 5.12%. The average availability rate of spirometers in primary care institutions was 8.94% (667/7 458) . The average availability rate of spirometers in community health centers was higher than that of township health centers〔18.56% (289/1 557) vs 6.41% (378/5 901) , P

ABSTRACT OBJECTIVE Describe consumption patterns for monetary and non-monetary acquisition of medicines according to age and income groups, highlighting pharmaceuticals associated with health programs with specific access guarantees. METHODS Descriptive observational study using microdata from the 2017–2018 Pesquisa de Orçamentos Familiares (Household Budget Survey, POF/IBGE). We initially reviewed programs/policies with specific guarantees of access to medicines in the SUS. Using the pharmaceutical product list of POF-4 (chart 29 of the questionnaire on individual expenditures), we selected the medicines related to these programs. We then described frequencies and percentages for not reporting medicine consumption and for reporting consumption (either through monetary or non-monetary acquisition) according to age and income groups. For medicines with distinctive access guarantees, we compared average monthly values of acquisitions and consumption patterns by age and income. RESULTS 63% of those in the ≤ 2 minimum wage (MW) household income group did not report consuming medicines in the last month. Among those earning > 25 MW, 44.3% did not report consumption. Non-monetary acquisitions of medicines were mainly reported for the < 10 MW group and for the elderly and accounted for 20.5% of the total consumption of medicines (in value). For policies with specific access guarantees, non-monetary acquisitions reached 33.6% of total consumption. This percentage varied for the various selected medicines: vaccines, 83.3%; cancer drugs, 70.3%; diabetes, 47.9%; hypertension, 35.9%; asthma and bronchitis, 29.2%; eye problems, 14%; prostate and urinary tract, 10.7%; gynecological, 11.6%; and contraceptives, 9.7%. CONCLUSION Shares for non-monetary acquisitions of medicines are still low but benefit mainly lower-income and older age groups. Policies and programs with specific access guarantees to medicines have increased access. Results suggest the need to strengthen and expand pharmaceutical care policies.

Objective: To describe and analyze the availability and factors related to the presence of analgesics and non-steroidal anti-inflammatory drugs in the Brazilian public primary healthcare system. Material and Methods: This was a cross-sectional study that evaluated 17,903 health units that participated in the National Program for Primary Care Access and Quality Improvement (2013-2014). The dependent variable was defined as the presence of metamizole, ibuprofen, and acetaminophen in a sufficient amount. The independent variables included the type of primary health care unit, the presence of a medication disposal area, the number of physicians, nurses, and dental practitioners; and the number of primary care units with family and oral health teams. For statistical analysis, unadjusted and adjusted Odds Ratio (OR) (95% CI) were presented. Results: The three medicines were available in 62.4% of the units. Regarding Health Clinics, the Basic Health Units (OR= 1.31, CI95% 1.18-1.44), Polyclinic (OR= 2.00, 95% CI, 1.15 -3.48), and others (OR= 1.37; 95% CI 1.14-1.63) had higher chances of availability of all three drugs. The presence of a disposal area (OR = 1.64, 95% CI 1.51-1.77) and the number of physicians (OR= 1.04, 95% CI 1.00-1.08), nurses (OR= 1.08, 95% CI 1.03- 1.13), and dental practitioners (OR= 1.09, 95% CI 1.04-1.14) increased the availability odds of the analyzed drugs in the service. Conclusion: The structure of the healthcare units and the higher number of professionals were positively associated with the availability of these drugs.

BACKGROUND: Tablet splitting appears common in older adults, but its safety, and the factors associated with this practice, remain unclear. OBJECTIVE: To identify which psychotropic drugs are most often split, which doses are intended with this practice, and whether these doses are provided by the Brazilian Unified Health System (SUS) or commercially available. METHODS: Cross-sectional descriptive study of 632 geriatric outpatients. The number of individuals who split tablets was identified, as well as the psychotropic drugs they used and split. The availability of these drugs on the SUS network and on the market was assessed by checking the 2017 National Formulary of Essential Medicines (RENAME 2017) and the Dictionary of Proprietary Medicinal Products (Dicionário de Especialidades Farmacêuticas) respectively. RESULTS: Tablet splitting was reported by 178 patients (28.2%). This practice was significantly more common among those aged 80 years or older. Tablet splitting was significantly associated with a greater number of medical visits and a higher pill burden. The most commonly affected therapeutic classes were antipsychotics (23.9%), other psychotropic drugs (18.7%) and antidepressants (12.3%). Of the 20 psychotropic drugs split, 45% were available on the SUS. CONCLUSIONS: Tablet splitting poses a challenge, as there is no guarantee of uniformity of concentration of the active ingredient in the split halves. Although the psychotropic drugs that were split in this sample are commercially available, most were not available from SUS in the desired dose forms for older adults.

Serious hematological adverse drug reactions (HADRs) may lead to or prolong hospitalization and even cause death. The aim of this study was to determine the regulatory factors associated with HADRs caused by drugs that were authorized up to July 2023 by the European Medicines Agency (EMA) and to evaluate the frequency of HADRs. Using a cross-sectional approach, the type and frequency of HADRs were collected from the Summaries of Product Characteristics of Drugs Authorized by the EMA and analyzed within proprietary, nonproprietary, and biosimilar/biological frameworks. Multivariate statistical analysis was used to investigate the associations of generic status, biosimilar status, conditional approval, exceptional circumstances, accelerated assessment, orphan drug status, years on the market, administration route, and inclusion on the Essential Medicines List (EML) with HADRs. In total, 54.78% of proprietary drugs were associated with HADRs at any frequency, while anemia, leucopenia, and thrombocytopenia were observed in approximately 36% of the patients. The predictors of any HADR, anemia, and thrombocytopenia of any frequency are generic status, biosimilar status, and inclusion on the EML, while the only protective factor is the administration route. Biosimilars and their originator biologicals have similar frequencies of HADRs; the only exception is somatropin. Knowledge of the regulatory factors associated with HADRs could help clinicians address monitoring issues when new drugs are introduced for the treatment of patients., (© 2024. The Author(s).)

Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and have the following interests to declare: ALG is currently a member of the South African National Essential Medicines List Committee and previously served on the WHO Expert Committee on the Selection and Use of Essential Medicines.

Background: Diabetes is a major global public health burden. Effective diabetes management is highly dependent on the availability of affordable and quality-assured essential medicines (EMs) which is a challenge especially in low-and-middle-income countries such as Ethiopia. This study aimed to assess the accessibility of EMs used for diabetes care in central Ethiopia's public and private medicine outlets with respect to availability and affordability parameters., Methods: A cross-sectional study was conducted in 60 selected public and private medicine outlets in central Ethiopia from January to February 2022 using the World Health Organization/Health Action International (WHO/HAI) standard tool to assess access to EMs. We included EMs that lower glucose, blood pressure, and cholesterol as these are all critical for diabetes care. Availability was determined as the percentage of surveyed outlets per sector in which the selected lowest-priced generic (LPG) and originator brand (OB) products were found. The number of days' wages required by the lowest paid government worker (LPGW) to purchase a one month's supply of medicines was used to measure affordability while median price was determined to assess patient price and price markup difference between public procurement and retail prices., Results: Across all facilities, availability of LPG and OB medicines were 34.6% and 2.5% respectively. Only two glucose-lowering (glibenclamide 5 mg and metformin 500 mg) and two blood pressure-lowering medications (nifedipine 20 mg and hydrochlorothiazide 25 mg) surpassed the WHO's target of 80% availability. The median price based on the least measurable unit of LPG diabetes EMs was 1.6 ETB (0.033 USD) in public and 4.65 ETB (0.095 USD) in private outlets. The cost of one month's supply of diabetes EMs was equivalent to 0.3 to 3.1 days wages in public and 1.0 to 11.0 days wages in private outlets, respectively, for a typical LPGW. Thus, 58.8% and 84.6% of LPG diabetes EMs included in the price analysis were unaffordable in private and public outlets, respectively., Conclusions: There are big gaps in availability and affordability of EMs used for diabetes in central Ethiopia. Policy makers should work to improve access to diabetes EMs. It is recommended to increase government attention to availing affordable EMs for diabetes care including at the primary healthcare levels which are more accessible to the majority of the population. Similar studies are also recommended to be conducted in different parts of Ethiopia., (© 2024. The Author(s).)

The World Health Organization (WHO) published its first Essential Medicines List (EML) in 1977, and it is updated biennially. One might reasonably think drugs on the EML are there because they are critical to effective, evidence-based patient care and intervention. One might not reasonably guess, however, that a particular drug's supply chain vulnerabilities that make it a shortage risk would contribute to a drug's listing on the EML. This commentary on a case first describes why the WHO makes the EML and suggests reasons why it might be important to consider a drug's shortage risk when revising and updating it. This commentary also suggests how distinguishing "essential" drugs from "vulnerable" drugs could bolster supply chain resiliency and mitigate drug shortages' disruptions to patient care., (Copyright 2024 American Medical Association. All Rights Reserved.)

Objective: The debate surrounding access to medicines in Nigeria has become increasingly necessary due to the high cost of essential medicine drugs and the prevalence of counterfeit medicines in the country. The Nigerian government has proposed the implementation of the National Health Insurance Scheme (NHIS) to address these issues and guarantee universal access to essential medicines. Access was investigated using the 3 A's (accessibility, affordability, and availability). This paper investigates whether the NHIS is a viable pathway to sustained access to medicines in Nigeria., Design: This was a cross-sectional study using a mixed-methods design. Both qualitative and quantitative methods were utilized for the study., Setting: This study was conducted at NHIS-accredited public and private facilities in Enugu State., Participants: 296 randomly selected enrollees took part in the quantitative component, while, 6 participants were purposively selected for the qualitative component, where in-depth interviews (IDIs) were conducted face-to-face with NHIS desk officers in selected public and private health facilities., Results: The quantitative findings showed that 94.9% of respondents sought medical help. Our data shows that 78.4% of the respondents indicated that the scheme improved their access to care (accessibility, affordability, and availability). The qualitative results from the NHIS desk officers showed that respondents across all the socio-economic groups reported that the NHIS had marginally improved access to medicine over the years. It was also observed that most of the staff in NHIS-accredited facilities were not adequately trained on the scheme's requirements and that most times, essential drugs were not readily available at the accredited facilities., Conclusion: The study findings revealed that although the NHIS has successfully expanded access to medicines, there remain several challenges to its effective implementation and sustainability. Additionally, the scheme's coverage of essential medicines is could be improved even more, leading to reduced access to needed drugs for many Nigerians. A focus on the 3As for the scheme means that all facility categories (private and public) and their interests (where necessary) must be considered in further planning of the scheme to ensure that things work out well., (© 2024. The Author(s).)

Objective: The rational use of medicines offers a cost-saving strategy to maximize therapeutic outcomes for developing and developed countries. The aim of this study was to evaluate the rational use of medicines for selected noncommunicable diseases (NCDs) at three pharmacies at public hospitals in Jamaica using the World Health Organization's (WHO's) prescribing indicators., Methods: In this retrospective cross-sectional study, prescriptions for adult outpatients containing at least one medicine for cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease or asthma that were filled between January and July 2019 were reviewed using WHO's prescribing indicators for the rational use of medicines. Data were analyzed and expressed as descriptive and inferential statistics. For all analyses conducted, significance was determined at P < 0.05., Results: A total of 1 500 prescriptions covering 5 979 medicines were reviewed; prescriptions were mostly written for female patients aged 42-60 years. Polypharmacy was observed in 35.6% (534) of prescriptions, and there was an average of 4 medicines per prescription, with a maximum of 17. Most of the prescriptions at each site were filled, with the main reason for not dispensing a medicine being that it was out of stock. Generic prescribing was high for all sites, accounting for more than 95% (5 722) of prescribed medicines. There was full compliance with prescribing according to the WHO Model List of Essential Medicines at two of the sites, but it was just off the target at Site 1, by 1.4%., Conclusions: The WHO guidelines for the rational use of medicines were followed with respect to the proportion of medicines prescribed from the WHO Model List and the proportion of antibiotics prescribed. The number of medicines per prescription and the proportion of medicines prescribed by generic name did not meet the WHO criteria. However, prescribing was aligned with treatment guidelines for the selected NCDs., Competing Interests: Conflicts of interest. None declared.

Objectives: Lockdowns and border closures impacted medicine availability during the COVID-19 pandemic. This study aimed to assess the availability of essential, generic medicines for chronic diseases at public pharmaceutical supply agencies in Ethiopia., Design: Comparative cross-sectional study., Setting: The availability of essential, generic medicines for chronic diseases was assessed at two public pharmaceutical supply agency hubs., Participants: The current study included public supply agency hub managers, warehouse managers and forecasting officers at the study setting., Outcomes: The assessment encompassed the availability of chronic medicines on the day of data collection, as well as records spanning 8 months before the outbreak and 1 year during the pandemic. A total of 22 medicines were selected based on their inclusion in the national essential drug list for public health facilities, including 17 medicines for cardiovascular disease and 5 for diabetes mellitus., Results: The results of the study indicate that the mean availability of the selected basket medicines was 43.3% (95% CI: 37.1 to 49.5) during COVID-19, which was significantly lower than the availability of 67.4% (95% CI: 62.2 to 72.6) before the outbreak (p<0.001). Prior to COVID-19, the overall average line-item fill rate for the selected products was 78%, but it dropped to 49% during the pandemic. Furthermore, the mean number of days out of stock per month was 11.7 (95% CI: 9.9 to 13.5) before the outbreak of COVID-19, which significantly increased to 15.7 (95% CI: 13.2 to 18.2) during the pandemic, indicating a statistically significant difference (p<0.001). Although the prices for some drugs remained relatively stable, there were significant price hikes for some products. For example, the unit price of insulin increased by more than 130%., Conclusion: The COVID-19 pandemic worsened the availability of essential chronic medicines, including higher rates of stockouts and unit price hikes for some products in the study setting. The study's findings imply that the COVID-19 pandemic has aggravated already-existing medicine availability issues. Efforts should be made to develop contingency plans and establish mechanisms to monitor medicine availability and pricing during such crises., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Childhood cancer presents significant acute and long-term challenges for patients,families, communities, and health systems. Although meaningful strides have been made in research and treatment, severe outcome disparities prevail between low- and middle-income countries (LMICs) and high-income countries (HICs), with childhood cancer survival rates lower than 20% in LMICs, as compared with over 80% across many HICs. In recent years, greater emphasis has been placed on health system strengthening as a means to develop domestic policy and capacity for sustainable improvements in childhood cancer outcomes in LMICs. In pursuit of a systems approach to childhood cancer in LMICs, our research team developed the Paediatric Oncology System Integration Tool (POSIT)-the first comprehensive framework for the design and evaluation of childhood cancer systems. Since its development, POSIT has been applied in an exploration of key determinants of access to essential childhood cancer medicines across two separate multi-site studies. In this commentary, we explore the value of the POSIT framework and toolkit as a constructive systems-level guide for examining interactions between childhood cancer-specific programs and encompassing health system. socio-political, and economic contexts., Competing Interests: Declaration of Competing Interest We declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

The prevalence of substandard and falsified (SF) antimicrobial drugs is increasing around the globe. This poses a great concern for the healthcare system. The consumption of SF antimicrobial drugs has the potential to result in treatment failure, emergence and development of antimicrobial resistance, and ultimately a rise in mortality rate. The objective of this study was to assess the quality of four commonly used antimicrobials marketed in the cities of Dire Dawa and Jijiga and the town of Togo-Wuchale, which have high potential for illegal drug trade activities in Ethiopia because they are located near the border with Somalia. A total of 54 brands/samples of amoxicillin, amoxicillin/clavulanic acid, ciprofloxacin, and norfloxacin formulations were collected covertly from 43 facilities using a convenience sampling strategy from March 16 to March 29, 2022. The samples were first screened using Global Pharma Health Fund (GPHF)-Minilab protocols and then analyzed using U.S. Pharmacopoeial and British Pharmacopoeia official methods. The quality evaluation detected no falsified product; however, it showed that 14.3% of the samples failed the GPHF-Minilab screening test semiquantitatively. Overall, 22.2% of the products analyzed did not meet any of pharmacopoeial specifications assessed: 13%, 12.2%, and 11.1% of the products failed in assay, dissolution, and weight variation, respectively. Additionally, 56.3% of amoxicillin samples, 60% of amoxicillin/clavulanate, 20% of ciprofloxacin, and 54.5% of norfloxacin samples were found to be pharmaceutically nonequivalent with their respective comparator products regarding dissolution profiles. The study showed the presence of substandard antimicrobial medicines in the eastern Ethiopian market.

Objectives: Guidelines and essential medicine lists (EMLs) bear similarities and differences in the process that lead to decisions. Access to essential medicines is central to achieve universal health coverage. The World Health Organization (WHO) EML has guided prioritization of essential medicines globally for nearly 50 years, and national EMLs (NEMLs) exist in over 130 countries. Guideline and EML decisions, at WHO or national levels, are not always coordinated and aligned. We sought to explore challenges, and potential solutions, for decision-making to support trustworthy medicine selection for EMLs from a Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Working Group perspective. We primarily focus on the WHO EML; however, our findings may be applicable to NEML decisions as well., Study Design and Setting: We identified key challenges in connecting the EML to health guidelines by involving a broad group of stakeholders and assessing case studies including real applications to the WHO EML, South Africa NEML, and a multiple sclerosis guideline connected to a WHO EML application for multiple sclerosis treatments. To address challenges, we utilized the results of a survey and feedback from the stakeholders, and iteratively met as a project group. We drafted a conceptual framework of challenges and potential solutions. We presented a summary of the results for feedback to all attendees of the GRADE Working Group meetings in November 2022 (approximately 120 people) and in May 2023 (approximately 100 people) before finalizing the framework., Results: We prioritized issues and insights/solutions that addressed the connections between the EML and health guidelines. Our suggested solutions include early planning alignment of guideline groups and EMLs, considering shared participation to strengthen linkage, further clarity on price/cost considerations, and using explicit shared criteria to make guideline and EML decisions. We also provide recommendations to strengthen the connection between WHO EML and NEMLs including through contextualization methods., Conclusion: This GRADE concept article, jointly developed by key stakeholders from the guidelines and EMLs field, identified key conceptual issues and potential solutions to support the continued advancement of trustworthy EMLs. Adopting structured decision criteria that can be linked to guideline recommendations bears the potential to advance health equity and gaps in availability of essential medicines within and between countries., Competing Interests: Declaration of competing interest Tamara Kredo is a member of the South African National Essential Medicines List Committee and Standard Treatment Guidelines; Co-lead of South African GRADE Network; Cochrane Board member; Member of the National Advisory Group on Immunisation. Trudy Leong is a member of the SA GRADE Network. Michael McCaul is a Member of the South African Primary Health Care and Adult Hospital Level Expert Review Committee; Founding member of the SA GRADE Network. The remaining authors are all members of the GRADE Working Group, however, have no other interests to declare., (Copyright © 2024. Published by Elsevier Inc.)

In February 2023, following extensive discussions with stakeholders and data review, the Institute for Clinical and Economic Review issued final policy recommendations for treatment of relapsing multiple sclerosis (RMS) 1 : "All stakeholders have a responsibility and an important role to play in ensuring that all effective treatment options for patients with RMS, including off-label use of rituximab, are utilized in ways to help improve affordability and access and reduce health inequities." The report calls on payers to remove barriers to rituximab coverage, the American Academy of Neurology and the National MS Society to publicly endorse rituximab for RMS, and clinicians to advocate for coverage of rituximab and its biosimilars. In July 2023, the World Health Organization listed rituximab as an essential medicine for MS. 2 Yet not much has changed. Food and Drug Administration (FDA)-approved MS disease-modifying therapies continue to generate enormous profits for pharma, and rituximab remains hidden in plain sight.

Background: The most recent World Medicines Situation Report published in 2011 found substantial medicine availability and affordability challenges across WHO regions, including Africa. Since publication of the 2011 report, medicine availability and affordability has risen on the international agenda and was included in the Sustainable Development Goals as Target 3.8. While numerous medicine availability and affordability studies have been conducted in Africa since the last World Medicines Situation Report, there has not been a systematic analysis of the methods used in these studies, measures of medicine availability and affordability, categories of medicines studied, or geographic distribution. Filling this knowledge gap can help inform future medicine availability and affordability studies, design systems to monitor progress toward Sustainable Development Goal Target 3.8 in Africa and beyond, and inform policy and program decisions to improve medicine availability and affordability., Methods: We conducted a systematic scoping review of studies assessing medicine availability or affordability conducted in the WHO Africa region published from 2009-2021., Results: Two hundred forty one articles met our eligibility criteria. 88% of the articles (213/241) reported descriptive studies, while 12% (28/241) reported interventional studies. Of the 198 studies measuring medicine availability, the most commonly used measure of medicine availability was whether a medicine was in stock on the date of a survey (124/198, 63%). We also identified multiple other availability methods and measures, including retrospective stock record reviews and self-reported medicine availability surveys. Of the 59 articles that included affordability measures, 32 (54%) compared the price of the medicine to the daily wage of the lowest paid government worker. Other affordability measures were patient self-reported affordability, capacity to pay measures, and comparing medicines prices with a population-level income standard (such as minimum wage, poverty line, or per capita income). The most commonly studied medicines were antiparasitic and anti-bacterial medicines. We did not identify studies in 22 out of 48 (46%) countries in the WHO Africa Region and more than half of the studies identified were conducted in Ethiopia, Kenya, Tanzania, and/or Uganda., Conclusion: Our results revealed a wide range of medicine availability and affordability assessment methodologies and measures, including cross-sectional facility surveys, population surveys, and retrospective data analyses. Our review also indicated a need for greater focus on medicines for certain non-communicable diseases, greater geographic diversity of studies, and the need for more intervention studies to identify approaches to improve access to medicines in the region., (© 2024. The Author(s).)

Background: Uganda imports approximately 90% of its medicines, with about 60% being distributed by the private sector. To discourage importation and promote local production of 37 selected locally manufactured medicines, the Ugandan government through the Ministry of Health in 2017 increased the import verification fees from 2 to 12%. The increase in verification fees ultimately affects cost and availability of these medicines. This study aimed to assess the cost and availability of the selected essential medicines after the 12% increase in verification fees in Uganda., Methods: A cross sectional study among 328 wholesale and retail pharmacies and seven key informant interviews was conducted using a pretested data collection checklist and in-depth interview guide from February to September 2021 in Uganda. Data on the availability and prices of the medicines before (2017) and after (2020) the increase in verification fees was collected. Paired sample T-Test was used to test if there is a significant difference in prices before and after the 12% increase in verification fees., Results: Mean availability of imported medicines was higher (54.8%, CI: 49.3-60.4) than the locally produced medicines (37.1%, CI: 31.9-42.7) except for locally manufactured parenteral preparations (54.6.%, CI: 49.1-60.1). Availability of locally produced medicines was mainly low (45%) while the imported medicines were fairly high (74%). Most commonly available locally manufactured medicines were Surgical spirit (89.9%), ORS (86%), Dextrose 5% solution (74.4%), Paracetamol 500 mg Tablets (73.8%) and Sodium Chloride 0.9% solution (72.9%). Most commonly available imported medicines were; Omeprazole 20 mg (94.2%), Amoxicillin Trihydrate 125 mg/5 ml (92.4%), Ciprofloxacin 500 mg (91.4%), Paracetamol Suspension 120 mg/5 ml (91.5%) and Metronidazole 200 mg Tablets (88.1%). Increase in lowest-priced local and imported medicines was significant for 10 (23.8%) and 7 (15.9%) of the medicines respectively. The median prices of imported medicines were generally higher than locally produced medicines. The median unit prices of 12 (28.6%) locally produced medicines and 20 (47.6%) imported medicines were higher than the international median unit prices., Conclusions: The overall availability of imported medicines was still higher than the local medicines. The median prices of local and imported medicines generally increased or remained the same after the introduction of import verification fees. There is a need for price controls and transparency in the private sector., (© 2024. The Author(s).)

Background: Lower-middle income countries face drastic challenges in Access to essential medicines. Data regarding Pakistan is scarce with no comprehensive study in this regard. The objectives of the study are to document and compare public and private sector availability of all essential antibiotics as well as to conduct a comparison among the AWaRe groups., Methods: The study analyzed 103 essential antibiotics comprising 51 Access, 29 Watch, 6 Reserve, and 17 anti-tuberculosis drugs from 15 th August to 10 th September 2020 in Lahore, Pakistan. It included on-spot physical availability and availability trend surveys. The survey sites included five public tertiary care hospitals with one as anchor and four randomly selected. Their hospital pharmacies and one randomly selected private retail pharmacy from the vicinity each hospital comprised the ten sampling sites. Percentage availability for each antibiotic was categorized as high (>80%), fairly high (50-80%), low (30-<50%), very low ( < 30->0%), and not available (0%)., Results: The mean percentage on-spot availability was 23.76% ± 5.19 (14-25%) for public facilities and 59.20% ± 4.45 (54-66%) for private sector retail pharmacies. The overall percentage of available essential antibiotics varied significantly ( p ** < 0.001) in public and private sector sampling sites. Except for the Watch group, all other groups showed the mode of 0% availability. A significant difference ( p **** < 0.00001) was seen in percentage availability by Access, Watch, Reserve, and anti-TB-all groups of essential antibiotics. The availability trend survey revealed a list of 18 medicines as 'as never been available', and five medicines were 'not available for 5 years or more than 5 years.' Fourteen medicines as 'never been heard.', Conclusion: Non-availability of essential medicines is a significant public health challenge at public-sector facilities in Pakistan. It was observed that a number of essential antibiotics were not available in both public and private sectors. A number of corrective strategies are required. This includes the engagement of stakeholder and government bodies. This can help to improve supply chain barriers., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Rafi, Anjum, Usman, Nawaz, Chaudhry, Babar and Rasheed.)

Objective: The lack of anticancer drugs for curative and supportive purposes is the critical reason for the low survival rate in low-and-middle-income countries. This study aims to analyze whether the National Essential Medicines List (NEML) and Registered Essential Medicines List (REML) are in concordance with the World Health Organization (WHO) Essential Medicines List (EML) and whether the formularies prevalent in the country are parallel to each other and to the NEML., Method: An observational study design was used in which antineoplastic drugs from the 2021 NEML and REML were compared with 2021 WHO EML to evaluate their availability in Pakistan. Market access was determined. Moreover, the formularies of six different hospital types were compared with each other and with the NEML, and REML to estimate the availability within hospitals., Results: There were 66 anticancer drugs in 2021 WHO EML and all were found in Pakistan's 2021 NEML but only 48 drugs (73%) were found in the REML. Hydroxycarbamide and dasatinib were two registered drugs absent in all hospitals' formularies. The market access for anticancer medicines was 73% (48 of 66). Semigovernment hospital (86%) has the highest availability, followed by the government hospital (80%). All the hospitals have unregistered drugs including bortezomib, lenalidomide, and mesna., Conclusion: Pakistan's NEML adopts WHO EML abruptly but all medicines are not registered. The hospitals are trying their best to increase availability but optimum drug regulations to revise NEML based on the country's requirements and emphasizing registration of anticancer medicines are needed to improve the country's availability of antineoplastic agents., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: We evaluated the uptake of medicines licensed as orphan drugs by the United States Food and Drug Administration (FDA) or European Medicines Agency (EMA) into the WHO Model list of essential medicines and the WHO Model list of essential medicines for children from 1977 to 2021., Methods: We collated and analysed data on drug characteristics, reasons for adding or rejecting medicines, and time between regulatory approval and inclusion in the lists. We compared trends in listing orphan drugs before and after revisions to the inclusion criteria of the essential medicines lists in 2001, as well as differences in trends for listing orphan and non-orphan drugs, respectively., Findings: The proportion of orphan drugs in the essential medicines lists increased from 1.9% (4/208) in 1977 to 14.6% (70/478) in 2021. While orphan drugs for communicable diseases have remained stable over time, we observed a considerable shift towards more orphan drugs for noncommunicable diseases, particularly for cancer. The median period for inclusion in the essential medicines lists after either FDA or EMA first approval was 13.5 years (range: 1-28 years). Limited clinical evidence base and uncertainty about the magnitude of net benefit were the most frequent reasons to reject proposals to add new orphan drugs to the essential medicines lists., Conclusion: Despite lack of a global definition of rare diseases, the essential medicines lists have broadened their scope to include medicines for rare conditions. However, the high costs of many listed orphan drugs pose accessibility and reimbursement challenges in resource-constrained settings., ((c) 2024 The authors; licensee World Health Organization.)

Background: Access to medicines is a global priority. Azerbaijan, Georgia, and Uzbekistan have different approaches to pricing policies for pharmaceuticals. The aim of this study was to analyze recent trends in the consumption and prices of non-communicable disease (NCD) medicines in Azerbaijan, Georgia, and Uzbekistan, in the outpatient setting., Methods: We included medicines for asthma and COPD, cancer, cardiovascular disease, diabetes, epilepsy, and mental disorders. Sales data for pharmaceutical products in community pharmacies were extracted from a commercial database. Changes in consumption and prices were analyzed across all included NCD medicines, by disease category and pharmacological group., Results: Consumption of NCD medicines was highest in Georgia, at twice the levels in Azerbaijan, and four times levels in Uzbekistan. Average prices of NCD medicines, weighted by consumption, increased by 26% in Georgia, but decreased by 3% in Azerbaijan and by 0.1% in Uzbekistan. Prices increased for all disease groups in Georgia (from +13% for epilepsy medicines to +86% for cancer), varied by group in Uzbekistan (from -22% for epilepsy medicines to +47% for cancer), while changes in Azerbaijan were smaller in magnitude (from -4% for medicines for cardiovascular disease to +11% for cancer). Cancer medicines had markedly higher prices in Uzbekistan, and asthma and COPD medicines had markedly higher prices in Azerbaijan and Uzbekistan., Conclusions: Georgia showed the highest outpatient consumption of NCD medicines, suggesting the broadest access to treatment. However, Georgia also saw marked price increases, greater than in the other countries. In Georgia, where there was no price regulation, widespread price increases and increases in consumption both contribute to increasing pharmaceutical expenditures. In Azerbaijan and Uzbekistan, increases in outpatient pharmaceutical expenditures were primarily driven by increases in consumption, rather than increases in price. Comparing trends in consumption and pricing can identify gaps in access and inform future policy approaches., Competing Interests: NK has received funding from the World Health Organization, Health Transform Forum/GIZ, Childhood without diabetes/World Diabetes Foundation and declares no competing interests. DG has received funding from the World Health Organization, Global Justice Now, Medicines Patent Pool, Médecins Sans Frontières, STOPAIDS, Treatment Action Group, and the World Intellectual Property Organization, and declares no competing interests. SK is a salaried employee of WHO Europe and declares no conflict of interest. EA receives funding from the Azerbaijan State Advanced Training Institute for Doctors named after A.Aliyev and declares no conflicts of interest. PH is a PhD researcher of Pharmaceutical Faculty of the Azerbaijan State Advanced Training Institute for Doctors named after A. A. Aliyeva and declares no conflicts of interest. ZE receives money from the State Medical Insurance Fund of Uzbekistan in the form of a salary and declares no conflicts of interest. NAM is a salaried employee of WHO Europe and declares no conflict of interest., (Copyright: © 2023 Kadyrova et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Competing Interests: DP, GO, CG, and CB were commissioned by WHO to develop the two applications for the WHO Model List of Essential Medicines for Children submitted to the 24th WHO Expert Committee on the Selection and Use of Essential Medicines. Funding for this commissioned work by DP, GO, CG, and CB was paid by WHO to the WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation of the University of Verona.

Background: Fair access to essential medicines is a significant parameter in fulfilling the right to basic health., Aim: We investigated the availability, prices and affordability of essential medicines for chronic diseases in Ankara, Türkiye., Methods: We used the procedures outlined in the WHO and Health Action International guidelines for measuring prices, availability, affordability, and price components of medicines. The sample consisted of 334 (14%) of the 2354 pharmacies in Ankara, and 24 essential medicines for cardiovascular diseases, diabetes, chronic respiratory diseases, and palliative care, adopted from the WHO Model List of Essential Medicines (2021). We collected the data in 2021 using a questionnaire administered through face-to-face survey and analysed the data using SPSS version 22., Results: The findings showed that 15 medicines (62.5% of the selected medicines) met the 80% availability target set by WHO, while 9 did not. The original medicines were more readily available than the generic ones. Among the original medicines, furosemide (10.11) and acetylsalicylic acid (9.26) had the highest median price ratios. The generic medicines seemed to be more affordable than original medicines. Glibenclamide, budesonide, gliclazide, and diazepam had low availability and were sold at higher prices than their international reference prices., Conclusion: This research highlights priority areas of action to improve access to affordable medicines for chronic diseases in Ankara, Türkiye., (Copyright © Authors 2023; Licensee: World Health Organization. EMHJ is an open access journal. This paper is available under the Creative Commons Attribution Non-Commercial ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO;https://creativecommons.org/licenses/by-nc-sa/3.0/igo).)

Introduction: The access, watch, and reserve (AWaRe) classification of antibiotics was developed in 2019 by the WHO Expert Committee on the Selection and Use of Essential Medicines as a tool to support antibiotic stewardship efforts at local, national, and global levels. The objectives of this study were to assess the availability of antibiotics as per WHO AWaRe classification at community pharmacies located around a tertiary care hospital in Lalitpur and to compare these antibiotics with the national essential medicine list of Nepal., Method: The cross-sectional study was conducted at community pharmacies located within a two-kilometer radius of a teaching hospital from August to November 2022. A total of 82 community pharmacies registered with the Nepal Chemist and Druggists Association and the Department of Drug Administration were studied. Data was collected using a standard proforma containing the names of the antibiotics classified as per the WHO's AWaRe classification., Results: Access group of antibiotics, Ampicillin, (82;100%), Amoxycillin, (82;100%), Flucloxacillin, (82;100%), and Metronidazole, (82;100%) were available in all community pharmacies. Results from the watch group showed that Azithromycin, (80; 97.6%) was available in all pharmacies followed by Cefixime, (80; 97.6%), Ciprofloxacin, (73; 89%), Levofloxacin, (74; 90.2%)and Ofloxacin, (74; 90.2%). Linezolid, (24; 29.3%) was the most common antibiotics available from the reserve group of antibiotics. Colistin was the second commonly available antibiotic. The most available antibiotic from the not recommended group were Ampicillin/Cloxacillin (82; 100%), followed by Piperacillin/Sulbactam, (39; 47.6%). There were differences in the classification of antibiotics between the WHO AWaRe list and the Essential Medicines list of Nepal in terms of numbers of antibiotics listed., Conclusion: Antibiotics from the not recommended and reserve groups were commonly available in community pharmacies. The implementation of antibiotic guidelines should be emphasized along with strict monitoring of the sale of antibiotics without a prescription in community pharmacy settings., Competing Interests: One of the authors, Dr P Ravi Shankar is an academic editor for PLoS One., (Copyright: © 2023 Jha et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

This study evaluated the clinical effectiveness of Ruyi Zhenbao Pills in the treatment of osteoarthritis, aiming to clarify its clinical advantages and promote rational drug use and related policy transformation. Following the relevant standards in Guidelines for the Comprehensive Evaluation of Drugs in Clinical Practice and Technical Specifications for the Clinical Comprehensive Evaluation of Chinese Patent Medicine, comprehensive research and related data on Ruyi Zhenbao Pills in the treatment of osteoarthritis were collected in the dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and traditional Chinese medicine(TCM) cha-racteristics(referred to as the &quot;6+1&quot; dimensions). Through evidence-based medicine, questionnaire surveys, health technology assessment, pharmacoeconomic evaluation, and other methods, a multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Ruyi Zhenbao Pills. Spontaneous reporting system data on adverse reactions and literature data indicate that the adverse reactions of Ruyi Zhenbao Pills are mostly general adverse reactions, with no reports of se-rious adverse reactions. The known risks are small, and its safety is rated as class A. It has been shown to effectively relieve joint pain and restore joint function in the treatment of osteoarthritis. However, more high-quality, large-sample randomized controlled trials are needed to further validate its effectiveness, which is rated as class B. There is evidence supporting its economic viability, and its economic is rated as class B. It demonstrates good clinical innovation, innovative enterprise service system, and industrial innovation, and innovation is rated as class A. Medical professionals and patients have a favorable perception of the suitability of Ruyi Zhenbao Pills, and further improvement can be made in terms of convenience of administration and promotion to facilitate rational drug use by healthcare professionals and patients. Suitability is rated as class B. The drug has a favorable price level, availability, and affordability, and accessibility is rated as class A. Ruyi Zhenbao Pills are a classic Tibetan medicinal prescription with excellent TCM theoretical characteristics. However, further research is needed on its use in human studies. TCM characteristics are rated as class B. Based on the evaluation results of the &quot;6+1&quot; dimensions, the comprehensive clinical evaluation is rated as grade B. Ruyi Zhenbao Pills have good clinical value in the treatment of osteoarthritis, and it is recommended to undergo the necessary procedures for conditional transformation into a policy for the management of essential clinical drugs.

Introduction: Formularies of essential medicines, such as Essential Medicines Lists (EMLs) and health emergency stockpiles, are intended to be always available, including in emergency situations, acting as important tools for access to medicines. The Emergency Medicines Buffer Stock (EMBS) in the United Kingdom (UK) was a stockpile of critical medicines managed by the UK Department of Health and Social Care (DHSC). We propose a new methodology for selecting and including medicines in EMLs and health emergency stockpiles and empirically apply it for selecting medicines in the case of the UK EMBS., Methods: We used Multi-Attribute Value Theory and Portfolio Decision Analysis to develop a three-phase methodological framework for medicines selection, involving: (i) the decision context definition and selection of evaluation criteria, (ii) the therapeutic area prioritisation, and (iii) the medicines value-for-money evaluation and product selection. The EMBS application took place in 2018-2019 and focused on therapeutic area prioritisation, involving primary data collection through expert interviews (n = 4), a workshop with DHSC decision-makers (n = 13), and an online survey with National Clinical Directors and relevant experts (n = 24). A Monte Carlo simulation supported therapeutic area prioritisation using the British National Formulary (BNF) classification., Findings: Two criteria sets were selected for i) therapeutic area prioritisation, reflecting the value concerns of population need and shortage severity, and ii) medicines evaluation, reflecting magnitude of clinical benefit and supply vulnerability, among others. Primary evidence was collected for "national need" and "shortage severity", based on which a "population health loss" index was developed. A total of 51 therapeutic areas were ranked using their index value while assessing the robustness of the ranking. The top ranked therapeutic area was antisecretory drugs and mucosal protectants, closely followed by diabetes drugs., Conclusions: The methodological application generated a ranking of therapeutic areas based on expected "population health loss" index, while addressing evidence uncertainty. The methodology can be adapted for other EMLs and emergency stockpile contexts to inform medicines selection., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Cancer is the second leading cause of death worldwide. Alongside other interventions, access to certain medicines may decrease cancer-associated mortality. Listing medicines on national essential medicines lists may improve health outcomes. We examine the association between cancer mortality amenable to care and the listing of cancer medicines on national essential medicines lists (NEMLs) of 124 countries., Methods: In this cross-sectional study, we determined the number of medicines used to treat eight cancers on NEMLs and used multiple linear regression to analyze the association between cancer health outcome scores and the number of medicines on NEMLs while controlling for GDP. A sensitivity analysis was also conducted using selected medicines., Findings: The number of cancer medicines on NEMLs was not associated with cancer health outcome scores when GDP was controlled for non-melanoma skin (p = 0.224), uterine (p = 0.221), breast (p = 0.145), Hodgkin's lymphoma (p = 0.697), colon (p = 0.299), leukemia (p = 0.103), cervical (p = 0.834), and testicular cancers (p = 0.178)., Interpretation: There was a weak association between listing medicines for eight cancers in NEMLs and amenable mortality. Further studies are required to explore association between cancer health outcomes and other factors such as actual availability of medicines listed, access to surgeries, accurate diagnosis, radiotherapy, and early detection., (© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Background: The COVID-19 pandemic has disrupted global health supply chains including manufacturing, storage, and delivery of essential medicines, testing kits, personal protective equipment, and laboratory reagents. We sought to document how pandemic impacted the procurement, prices, and supply chain of medical products in Zimbabwe., Methods: We conducted semistructured in-depth key informant interviews with 36 health system stakeholders in Zimbabwe involved in medicine procurement. Respondents included pharmacists, regulatory officers, and procurement and supply chain management professionals from public and private sectors., Results: Before the COVID-19 pandemic, respondents described experiencing long-standing resource constraints, medicine shortages, foreign currency shortages, and supply chain inefficiencies. The pandemic exacerbated this situation due to supply constraints, export restrictions, medicine shortages, and movement restrictions that disrupted logistical and stock management systems. Competitive bidding and tendering processes experienced reduced participation by international suppliers. Significant price increases were initially observed among internationally shipped medicines and for personal protective equipment to cover additional freight costs. COVID-19 pandemic impacts were moderated by reduced patient demand and lower health services utilization, resulting in fewer supply shocks and less price volatility. Further, health system adaptations such as switching treatment regimens, modifying dispensing schedules based on stock availability, redistributing stock of medicines among facilities, and new service delivery models such as integrated outreach services helped ensure continued patient access to medicines., Conclusions: Our findings highlight the need for policies that ensure continuity in access to health services and medical products, even during a pandemic, by avoiding blanket restrictions on medical product exports and imports. Pooled procurement, especially at regional and global levels, with long-term service agreements may help achieve greater resiliency to supply and price shocks from supply chain disruptions. Interventions across manufacturing, trade, and regulatory policy and service delivery models are also needed for supply chain resiliency., (© Yemeke et al.)

Introduction: Availability of essential medicines that meet the expected quality standards, in appropriate dosage forms at affordable prices is a fundamental prerequisite to fulfill healthcare needs of given a population. This study assessed available products, prices and affordability of essential medicines (EM) in community pharmacies in Sri Lanka with comparison of registration status from the National Medicines Regulatory Authority(NMRA)., Methods: A cross-sectional island-wide survey of 80 pharmacies was conducted according to World Health Organization and Health Action International Manual (WHO/HAI). Hundred medicines were selected from the global core list(n = 14), regional core list(n = 16) and the Sri Lanka Essential Medicine List (SL-EML) (n = 70) based on healthcare needs. Number of registered products in 2015 and 2021 were compared., Findings: Average availability was 85.4%(± 12.31) and availability was lowest in the Northern province (69.38 ± 21.18%)(p = 0.008). Availability between the state owned, franchise and privately owned pharmacies was not significantly different (p > 0.05). 89.4% medicines were affordable except for amiodarone, hydroxychloroquine, sitagliptin, soluble insulin, isophane insulin, losartan, levodopa carbidopa combination, clonazepam and ceftriaxone. The median price ratio (MPR) of 33.7% of medicines was less than 1 and MPR of 37.1% originator brands (OB) was over 3. Median number of generic brands in the market was 8(range 2-44), 9% of medicines had 20 or more products in the market and 72.7% medicines had more products available than the number registered in 2015. The average number of registered products were similar in 2015 (8.27) and 2021(7.59) (p = 0.15)., Conclusion: The overall availability of EMs in Sri Lanka was high in all categories of community pharmacies. Medicines were largely affordable and reasonably priced in 2015, although OBs were generally more expensive. Majority of medicines had more products in the market than the number of registered products., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Background: Access to essential medicines is a critical component of universal health coverage. However, the availability of essential medicines in Sudan isn't well studied. As well, most Sudanese people lack health insurance, making out-of-pocket spending the primary source of drug financing. Therefore, the affordability of medicines in Sudan is questionable, with only 30% of the total population being covered by a public health service or public health insurance. We undertook this study to assess the availability and prices of essential medicines in public-sector health facilities in Khartoum state. Moreover, this study aims at assessing patients' perceived affordability of essential medicines, and accommodation and acceptability of the public facility., Methods: A cross-sectional study was carried out at 30 primary healthcare facilities' drug dispensaries across three districts in Khartoum state. Within each Centre's dispensary unit, a standardized checklist evaluated the availability and affordability of 21 essential medicines selected from Sudan's national essential medicines list and assessed their storage conditions. Furthermore, 630 patients were selected from all dispensary units for an exit interview that assessed their perceived accessibility, acceptability, accommodation, and affordability of essential medicines. Data were collected through the Kobo toolbox and analyzed using SPSS version 26., Results: Participants' ratings of accessibility, affordability, accommodation, and acceptability were 3.7/5, 1.5/4, 5/6, and 5.4/6, respectively, with a 26.7% full access and weak correlation between some of the indices. The overall availability of adults and pediatric medicines was 36.8% 6.7%, respectively. Cost of a single course of treatment for 10 and 16 drugs out of the 19 drugs consumed exceeds the daily wage of insured and uninsured patients, with a median price ratio of 16.4 and 62.8, respectively. Moreover, the dispensary area conditions were found to be of good quality, yet the storerooms were not functioning in 40% of the outlets., Conclusion: Patients had limited access to their needed drugs due to high prices and physical unavailability, and primary healthcare capacities are not meeting the demands of citizens. The outcomes for the patients' access variables (accessibility, accommodation, acceptance, and affordability) are comparable to those in countries with low incomes. Ensuring access to free medicines is likely to improve patients' satisfaction with healthcare services and reduce private expenditure on medicines, which is a long-term, sustainable way towards universal health coverage in Sudan., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objectives: To audit national drug registers (NDRs) in Kenya, United Republic of Tanzania and Uganda with respect to national Essential Medicine Lists (EMLs) and to conduct an analysis of highly registered products including a sub-analysis of highly registered antimicrobial products., Design: Retrospective analysis of registration of essential medicines and medicinal products on NDRs as of February 2018., Setting: Not applicable., Participants: None., Main Outcome Measures: Registration status of essential medicines by country, essential medicine status of registered products by country and medicines with more than 50 registrations across all three countries., Results: A high proportion of essential medicines are not registered: Kenya 28% (175/632), United Republic of Tanzania 50% (400/797) and Uganda 40% (266/663). Of registered products on the NDRs, more than half are not essential: Kenya 71% (4350/6151), United Republic of Tanzania 64% (2278/3590) and Uganda 58% (2268/3896). When the three NDRs were combined, there were 42 medicines with over 50 registered products, accounting for 30% (4153/13637) of products, many of which were non-essential., Conclusions: Non-registration of essential medicines is a barrier to availability. Over-registration of medicines, particularly non-essential medicines, diverts regulatory resources towards registering non-priority and, sometimes, clinically sub-optimal medicines. The East African Community Medicines Registration Harmonization Project has the potential to improve access to key medicines if registration of essential medicines is prioritised and registration of non-essential medicines is restricted.

Since 1977, the WHO Model Lists of Essential Medicines (EML) have been a benchmark to guide the procurement of medicines at the national level, especially in low-income and middle-income countries. Aiming to include the most effective, safe, and cost-effective medicines for priority conditions, WHO updates the EML for adults and the EML for children every 2 years. Over the past 45 years, updates to the EML mental health section have been infrequent, in most cases with additions of individual medicines. A comprehensive revision of the entire section has never been attempted. With the aim of increasing the use of the WHO EML to expand the selection of the most effective and safe medicines for mental disorders, a series of evidence-based applications were submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines in 2022, recommending a substantial revision of the entire mental health section. In this Health Policy, we summarise the recommended update and the evidence justifying it. We also discuss challenges in the update process, suggesting possible solutions. The requested comprehensive revision of the WHO EML mental health section aligns the list with the latest evidence. The revision offers an opportunity for countries to promote access to the most effective, safe, and cost-effective medicines for mental disorders, contributing to universal health coverage and global mental health equity., Competing Interests: Declaration of interests DP, GO, BT, CG, and CB developed nine of the 13 applications submitted to the 24th WHO Expert Committee on the Selection and Use of Essential Medicines. WHO commissioned the nine applications, and the WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation of the University of Verona received funding from WHO for their development. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)