A Survey of Availability and Affordability of Polypills for Cardiovascular Disease in Selected Countries.

Background: The recent inclusion of polypills-fixed-dose combinations of antihypertensive medicines and a statin with or without aspirin-in the World Health Organization's Essential Medicines List (EML) reiterates the potential of this approach to improve global treatment coverage for cardiovascular diseases (CVDs). Although there exists extensive evidence on the effectiveness, safety and acceptability of polypills, there has been no research to date assessing the real-world availability and affordability of polypills globally. Methods: We conducted a cross-sectional survey, based on the WHO/Health Action International methodology, in 13 countries around the world. In the surveyed countries, we first ascertained whether any polypill was authorised for marketing and/or included in EMLs and clinical guidelines. In each country, we collected retail and price data for polypills from at least one public-sector facility and three private pharmacies using convenience sampling. Polypills were considered unaffordable if the lowest-paid worker spent more than a day's wage to purchase a monthly supply. Results: Polypills were approved for marketing in four of the 13 surveyed countries: Spain, India, Mauritius and Argentina. None of these countries included polypills in national guidelines, formularies, or EMLs. In the four countries, no surveyed public pharmacies stocked polypills. In the private sector, we identified seven unique polypill combinations, marketed by eight different companies. Private sector availability was 100% in Argentina and Spain. Most combinations (n = 5) identified were in India. Combinations found in India and Spain were affordable in the local context. A lowest-paid government worker would spend between 0.2 (India) and 2.8 (Mauritius) days' wages to pay the price for one month's supply of the polypills. Polypills were likely to be affordable if they were manufactured in the same country. Conclusion: Low availability and affordability of polypills in the public sector suggest that implementation remains poor globally. Context-specific multi-disciplinary health system research is required to understand factors affecting polypill implementation and to design and evaluate appropriate implementation strategies.

A quantitative comparison between the essential medicines for rheumatic diseases in children and young people in Africa and the WHO model list.

BACKGROUND: The World Health Organisation Essential Medicines List (WHO EML) guides National Essential Medicines Lists and Standard Treatment Guidelines for clearly identified disease priorities especially in low- and middle-income countries. This study compares the degree to which the basket of medicines recommended for rheumatic diseases in children and young people in National Essential Medicines Lists of countries in the WHO Africa region, corresponds to the 2021 WHO EML and WHO EML for children, as a proxy of availability. METHODS: An online search of the WHO medicines and health technology portal, the Health Ministry websites of the 54 African countries, PUBMED and Google Scholar, with search terms for 'National Essential Medicines List', AND/OR 'standard treatment guidelines' AND/OR 'Lista Nacional de Medicamentos Essenciais' AND/ OR 'Liste Nationale de Medicaments Essentiels' AND Africa AND/OR < Name of African country > was conducted. The number of medicines on the national lists were compared according to a predefined template of medicines; and the percentage similarity calculated. Descriptive statistics were derived using STATA. RESULTS: Forty-seven countries in the WHO Africa region have developed a National Essential Medicines List. Eleven countries do not have any medicines listed for rheumatic diseases. The majority of countries had less than or equal to 50% similarity with the WHO EML for rheumatic disease in children and young people, median 3 medicines (IQR 1- 4). The most common medicines on the national lists from Africa were methotrexate, sulfasalazine and azathioprine, with etanercept available in 6 countries. Seven countries had only one medicine, acetylsalicylic acid listed in the section 'Juvenile Joint diseases'. A multiple linear regression model for the predictors of the number of medicines on the national lists established that 20% of the variability was predicted by health expenditure per capita, socio-demographic index and the availability of rheumatology services (adult and/or paediatric) p = 0.006, with socio-demographic index (p = 0.035, 95% CI 0.64-16.16) and the availability of rheumatology services (p = 0.033, 95% CI 0.13 - 2.90) significant. CONCLUSION: Four countries (8.5%) in Africa have updated their National Essential Medicines Lists to reflect adequate care for children and young people with rheumatic diseases. Moving forward, efforts should focus on aligning available medicines with the WHO EML, and strengthening healthcare policy for rheumatology and pharmaceutical services, for affordable access to care and medicines.

Access to mifepristone, misoprostol, and contraceptive medicines in eight countries in the Eastern Mediterranean Region: descriptive analyses of country-level assessments.

BACKGROUND: Despite their importance in reducing maternal mortality, information on access to Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region is limited. METHODS: A standardized assessment tool measuring access to Mifepristone, Misoprostol, and contraceptive medicines included in the WHO essential medicines list (EML) was implemented in eight countries in the Eastern Mediterranean Region (Afghanistan, Iraq, Lebanon, Libya, Morocco, Palestine, Pakistan, and Somalia) between 2020-2021. The assessment focused on five access measures: 1) the inclusion of medicines in national family planning guidelines; 2) inclusion of medicines in comprehensive abortion care guidelines; 3) inclusion of medicines on national essential medicines lists; 4) medicines registration; and 5) procurement and forecasting of Mifepristone, Misoprostol, and contraceptive medicines. A descriptive analysis of findings from these eight national assessments was conducted. RESULTS: Only Lebanon and Pakistan included all 12 contraceptives that are enlisted in the WHO-EML within their national family planning guidelines. Only Afghanistan and Lebanon included mifepristone and mifepristone-misoprostol combination in post-abortion care guidelines, but these medicines were not included in their national EMLs. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs-and registered-in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan). However, only three countries procured misoprostol (Iraq, Morocco, and Somalia). CONCLUSION: These findings can guide efforts aimed at improving the availability of Mifepristone, Misoprostol, and contraceptive medicines in the Eastern Mediterranean Region. Opportunities include expanding national EMLs to include more options for Mifepristone, Misoprostol, and contraceptive medicines and strengthening the registration and procurement systems to ensure these medicines' availability were permitted under national law and where culturally acceptable.

Ensuring access to Mifepristone, Misoprostol, and contraceptive medicines is critical to improving women's health, and more specifically reducing maternal mortality and improving women's sexual and reproductive health in the Eastern Mediterranean Region.The aim of this study was to analyse findings from national assessments to capture information on the implementation of relevant policies and procedures. Those were the policies that ensure access to Mifepristone, Misoprostol, and contraceptive medicines in the public sector for the eight Eastern Mediterranean Region countries included in the study (Afghanistan, Iraq, Libya, Lebanon, Morocco, Palestine, Pakistan, and Somalia). The assessments were completed between 2020 and 2021.We found that most countries did not include all twelve contraceptives enlisted in the WHO essential medicines list (EML) in their national family planning guidelines. No country had developed a national abortion care guidelines nor included mifepristone (alone or in combination with misoprostol) on national EML. Libya and Somalia lacked a national regulatory authority for medicines registration. Most contraceptives included on the national EMLs for Lebanon, Morocco and Pakistan were registered. Misoprostol was included on the EMLs­and registered­in six countries (Afghanistan, Iraq, Lebanon, Morocco, Palestine, and Pakistan) yet, only three countries procured misoprostol (Iraq, Morocco, and Somalia).Our findings provide evidence on system-level barriers to availability of Mifepristone, Misoprostol, and contraceptive medicines (e.g., lack of guidelines or inclusion on EML, lack of registration and procurement) that can support policy and advocacy efforts to strengthen the pharmaceutical sector to better ensure availability of Mifepristone, Misoprostol, and contraceptive medicines to women in reproductive age at the country-level in accordance with the national law and prevailing culture.

Audit of essential medicine listing and registration status of medicines on standard treatment guidelines in Kenya, Tanzania and Uganda: Case study of malaria, tuberculosis, hypertension and type 2 diabetes mellitus.

Objectives: To determine alignment between national and World Health Organization (WHO) treatment recommendations, medicines prioritisation in country's essential medicines list (EML), and medicines availability in National drug register. Design: An audit of medicines for malaria, tuberculosis, hypertension and type 2 diabetes mellitus listed in the national standard treatment guidelines (STGs) of Kenya, Tanzania and Uganda, as of March 2021, against WHO treatment guidelines, and respective country EML and National drug register. Setting: Not applicable. Participants: None. Main outcome measures: Proportion of medicine in country's STGs that align with WHO treatment recommendations, country's EML and country's drug register. Results: Some disease areas had two sets of treatment guidelines - national STGs and disease-specific treatment guidelines (DSGs) developed at different times with different recommended medicines. Both STGs and DSGs included medicines not recommended by the WHO or not listed on the country EML and drug register. Non-WHO-recommended medicines accounted for 17/68 (25%), 10/57 (18%) and 3/30 (10%) of all STG medicines in Kenya, Tanzania and Uganda, respectively. For tuberculosis, the numbers and proportion of STG medicines listed on the respective national EMLs were 2/6 (33%), 15/19 (79%) and 4/5 (80%) in Kenya, Tanzania and Uganda. All tuberculosis medicines included in Kenya's and Uganda's STGs were registered compared with only 12/19 (63%) tuberculosis medicines in Tanzania's STG. Conclusions: Alignment between treatment guidelines, EMLs and drug registers is crucial for effective national pharmaceutical policy. Research is needed to understand the inclusion of medicines on STGs and DSGs which fall outside WHO treatment guidelines; the non-alignment of some STGs and DSGs, and STGs and DSGs including medicines which are not on country EML and drug register.

Access to essential medicines for diabetes care: availability, price, and affordability in central Ethiopia.

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.

Evaluation of Rational Medicines Use Based on World Health Organization Core Indicators: A Cross-Sectional Study in Five Health Districts in Mauritania.

Introduction: The rational use of medicines is essential for preventing adverse medicine reactions, achieving therapeutic outcomes, and optimizing treatment costs. While the irrational use of medicines is frequently reported in sub-Saharan Africa, to the best of our knowledge no formal studies have taken place in Mauritania thus far. The main objective of this study was therefore to analyze the rational use of medicines in public and private not-for-profit health facilities, in five health districts in Mauritania. Methods: We conducted a cross-sectional study to assess the rational use of medicines. We used the standard indicators derived from the methodologies of the World Health Organization (WHO) and International Network for Rational Use of Drugs (INRUD). Data were prospectively collected from 1050 prescriptions/patients, in thirty-one public and private not-for-profit health posts/centers in 5 health districts. The data were analyzed using the Statistical Package for the Social Sciences. P value less than 0.05 at 95% confidence interval considered for significance of relationships for associations in statistical test. Results: The average number of medicines per prescription was 2.21; 83.1% (1931/2325) of medicines were prescribed by generic name, but only 54% (1253/2325) were on the National Essential Medicine List (NEML). Antibiotics were prescribed in 62.4% (655/1050) of the consultations, and injectable medicines were prescribed in 15.6% (164/1050) of the consultations. The average consultation time was 16.32 minutes, and the average dispensing time was 97 seconds. Dispensed medicines were correctly labeled, and 83% (871/1050) of patients met the correct administration schedule. The NEML, and the "restricted NEML" for 76 commonly-used medicines, were available in all surveyed health facilities, but the National Therapeutic Guidelines were available in only 60.26% of them. Conclusion: Our findings indicate a possible excess of antibiotics prescriptions, and a likely lack of knowledge of the National Therapeutic Guidelines. There is a need to investigate in more detail the prescription patterns versus disease-specific therapeutic guidelines, and to qualitatively investigate the factors that contribute to the observed irrational prescribing. Moreover, training local staff in the rational use of medicines seems important.

Mental health services in Gauteng, South Africa: A proxy evaluation using pharmaceutical data.

Background: South African legislation advocates for equitable access to mental healthcare services integrated into general healthcare settings. Mental, neurological, and substance use (MNS) disorders are often comorbid. Pharmacoepidemiology provides indirect evidence of service provision for conditions amenable to medicine treatment. Aim: The study aims to evaluate medicine procurement for MNS disorders at different service levels in the health system. Setting: The Public health sector, Gauteng province formed the setting for the study. Method: A secondary analysis of the Gauteng pharmaceutical database was conducted using Anatomic Therapeutic Chemical (ATC) and defined daily dose (DDD) methodology. Anatomic Therapeutic Chemical classes of medicines for MNS disorders were included. Defined daily doses and costs were calculated per 1000 population served by each facility and service level. Statistical comparisons were made using chi-square testing. Results: General healthcare settings accounted for 90% (R118 638 248) and specialised hospitals for 10% (R13 685 032) of expenditure on medicines for MNS disorders, procuring 94% (n = 49 442 474) and 6% (n = 3 311 528) of DDDs, respectively. Although district clinics procured 60% of DDDs, they procured the least per 1000 population served, whereas district hospitals procured the most. For almost all ATC classes, procurement differed significantly between municipalities at every service level and between specialised hospitals. Conclusion: In Gauteng province, most medicines for MNS disorders are procured by general healthcare services, but access to care may not be equitable. While population coverage at district clinics appears low, district hospitals may experience the greatest care burden. Research regarding quality of care at each service level is recommended. Contribution: This study provides insight into service provision for MNS disorders.

Inclusion of Polypills for Prevention of Cardiovascular Disease in the 23rd World Health Organization Model List of Essential Medicines: A Significant Step Towards Reducing Global Cardiovascular Morbidity and Mortality.

This commentary describes the potential impact of inclusion of polypills for prevention of cardiovascular disease in the 23rd WHO Model List of Essential Medicines, and provides a roadmap for adoption, implementation, sustainment, and scale-up. The World Health Organization's endorsement of polypills is essential for improving global access, particularly in low- and middle-income countries. The greatest health gains are expected in a primary prevention population which has a significantly higher burden of fatal and non-fatal cardiovascular disease compared with the population of individuals with prevalent cardiovascular disease. A focus on adoption, implementation, sustainment, and scale-up of polypills for prevention of cardiovascular disease is needed including increasing supply of available polypills and incorporating polypills into the World Health Organization HEARTS technical package for integration into primary care systems to realize these benefits for population health. Widespread implementation of polypills for prevention of cardiovascular disease has the potential to equitably reduce the impact of cardiovascular disease globally by simplifying treatment options and expanding accessibility across economic levels, both across and within countries.

Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil.

OBJECTIVE: This work compares the marketing authorization, labels and dosage forms of medicines in the WHO Model List of Essential Medicines for Children (EMLc) in China, the Russian Federation and Brazil to urge policymakers to pay more attention to paediatric medication. METHODS: Medicines were selected from the 8th EMLc. By searching relevant databases, which include different types of medical information in China, the Russian Federation and Brazil, the marketing authorization, labels and dosage forms of paediatric medicines in the three countries were evaluated. RESULTS: A total of 485 drug products containing 312 active pharmaceutical ingredients listed in the WHO EMLc were evaluated. Among them, 344 products were approved for use in China, 286 in the Russian Federation and 264 in Brazil. Out of the 344 approved medicines, 317 (92.15%) were authorized for paediatric use in China, 224 (78.32%) in the Russian Federation and 218 (82.58%) in Brazil. In terms of guidance information labelling on drug labels, 75.08%, 83.04% and 88.07% of paediatric drugs approved in China, the Russian Federation and Brazil, respectively, clearly indicated the usage and dosage for paediatric use. Additionally, injections and tablets were the most prevalent dosage forms in these three countries. CONCLUSION: There is still scope for enhancing the marketing authorization and development of dosage forms for paediatric medicines in the three countries. Furthermore, additional measures are being implemented to enhance the information provided on drug labels for children, particularly in China.

Ten-year trends of antibiotic prescribing in surgery departments of two private sector hospitals in Central India: a prospective observational study.

BACKGROUND: Inappropriate antibiotic use contributes to the global rise of antibiotic resistance, prominently in low- and middle-income countries, including India. Despite the considerable risk of surgical site infections, there is a lack of antibiotic prescribing guidelines and long-term studies about antibiotic prescribing in surgery departments in India. Therefore, this study aimed to analyse 10 years' antibiotic prescribing trends at surgery departments in two tertiary-care hospitals in Central India. METHODS: Data was prospectively collected from 2008 to 2017 for surgery inpatients in the teaching (TH-15,016) and the non-teaching hospital (NTH-14,499). Antibiotics were classified based on the World Health Organization (WHO) Access Watch Reserve system and analysed against the diagnoses and adherence to the National List of Essential Medicines India (NLEMI) and the WHO Model List of Essential Medicines (WHOMLEM). Total antibiotic use was calculated by DDD/1000 patient days. Time trends of antibiotic prescribing were analysed by polynomial and linear regressions. RESULTS: The most common indications for surgery were inguinal hernia (TH-12%) and calculus of the kidney and ureter (NTH-13%). The most prescribed antibiotics were fluoroquinolones (TH-20%) and 3rd generation cephalosporins (NTH-41%), and as antibiotic prophylaxis, norfloxacin (TH-19%) and ceftriaxone (NTH-24%). Access antibiotics were mostly prescribed (57%) in the TH and Watch antibiotics (66%) in the NTH. Culture and susceptibility tests were seldom done (TH-2%; NTH-1%). Adherence to the NLEMI (TH-80%; NTH-69%) was higher than adherence to the WHOMLEM (TH-77%; NTH-66%). Mean DDD/1000 patient days was two times higher in the NTH than in the TH (185 vs 90). Overall antibiotic prescribing significantly increased in the TH (ß1 =13.7) until 2012, and in the NTH (ß2 =0.96) until 2014, and after that decreased (TH, ß2= -0.01; NTH, ß3= -0.0005). The proportion of Watch antibiotic use significantly increased in both hospitals (TH, ß=0.16; NTH, ß=0.96). CONCLUSION: Total antibiotic use decreased in the last three (NTH) and five years (TH), whereas consumption of Watch antibiotics increased over 10 years in both hospitals. The choice of perioperative antibiotic prophylaxis was often inappropriate and antibiotic prescribing was mostly empirical. The results of this study confirmed the need for antibiotic prescribing guidelines and implementation of antimicrobial stewardship programs.

The promise of POSIT: Real-world application of the Paediatric Oncology System Integration Tool.

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.

GRADE Concept 7: Issues and Insights Linking Guideline Recommendations to Trustworthy Essential Medicine Lists.

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.

O fim da extensão das patentes e as Parcerias para Desenvolvimento Produtivo: reflexos no acesso a medicamentos no Brasil / The end of patent extensions and the Productive Development Partnerships: effects on access to medicines in Brazil

Resumo A covid-19 jogou luz sobre o impacto negativo da propriedade intelectual na saúde e deu nova relevância à Ação Direta de Inconstitucionalidade 5529/DF, que, acatada pelo Supremo Tribunal Federal em 2021, culminou na extinção da extensão automática de patentes no Brasil. Este estudo busca analisar o efeito do julgamento histórico da ADI 5529/DF sobre pedidos de patente e as patentes de interesse das Parcerias para Desenvolvimento Produtivo (PDP). Trata-se de um estudo com base em uma pesquisa documental de análise do andamento, até 31 de dezembro de 2020, de 90 pedidos de patente relacionados a 15 medicamentos objetos de PDP. Nos sites do Instituto Nacional de Propriedade Industrial, do Ministério da Saúde, da Anvisa e da Câmara de Regulação do Mercado de Medicamentos, foram pesquisadas variáveis para comparar o cenário patentário dos medicamentos com o das PDP. De 88 pedidos válidos, 28 patentes foram concedidas, das quais dezessete foram estendidas para mais de vinte anos (média de 24 anos e nove meses). A decisão do STF resultou em mais de 68 anos de monopólio perdidos, potencialmente desanuviando alternativas para a produção de genéricos no país. Neste momento de retomada das PDP, estratégias para a superação de barreiras patentárias deveriam ser incorporadas à política.

Abstract The COVID-19 pandemic has shed light on the negative impact of intellectual property on health and has given new relevance to the Direct Action of Unconstitutionality 5529/DF, which was ruled by the Supreme Court in 2021, resulting in the extinction of automatic patent extensions in Brazil. This documentary case study analyzes the effects of the judicial decision on patent applications and patents of interest for Productive Development Partnerships (PDP), investigating the progress of 90 patent applications related to 15 PDPs drugs of interest until Decembre 31, 2020. Variables for comparing the drug patent scenario with that of the PDPs were researched on the websites of the National Institute of Industrial Property, the Ministry of Health, ANVISA, and the Brazilian Medicines Market Regulation Chamber. Of 88 valid applications, 28 patents were granted, 17 of which had been extended to more than 20 years (24 years and 09 months average). The court decision resulted in a loss of over 68 years of monopoly, potentially opening alternatives for generic production. This resumption of the PDP policy should incorporate strategies to overcome patent barriers.

Mental health services in Gauteng, South Africa: A proxy evaluation using pharmaceutical data

Background: South African legislation advocates for equitable access to mental healthcare services integrated into general healthcare settings. Mental, neurological, and substance use (MNS) disorders are often comorbid. Pharmacoepidemiology provides indirect evidence of service provision for conditions amenable to medicine treatment. Aim: The study aims to evaluate medicine procurement for MNS disorders at different service levels in the health system. Setting: The Public health sector, Gauteng province formed the setting for the study. Method: A secondary analysis of the Gauteng pharmaceutical database was conducted using Anatomic Therapeutic Chemical (ATC) and defined daily dose (DDD) methodology. Anatomic Therapeutic Chemical classes of medicines for MNS disorders were included. Defined daily doses and costs were calculated per 1000 population served by each facility and service level. Statistical comparisons were made using chi-square testing. Results: General healthcare settings accounted for 90% (R118 638 248) and specialised hospitals for 10% (R13 685 032) of expenditure on medicines for MNS disorders, procuring 94% (n = 49 442 474) and 6% (n = 3 311 528) of DDDs, respectively. Although district clinics procured 60% of DDDs, they procured the least per 1000 population served, whereas district hospitals procured the most. For almost all ATC classes, procurement differed significantly between municipalities at every service level and between specialised hospitals. Conclusion: In Gauteng province, most medicines for MNS disorders are procured by general healthcare services, but access to care may not be equitable. While population coverage at district clinics appears low, district hospitals may experience the greatest care burden. Research regarding quality of care at each service level is recommended. Contribution: This study provides insight into service provision for MNS disorders.

Política industrial farmacéutica, un requisito clave para la autonomía sanitaria de Colombia / Pharmaceutical industrial policy, a key requirement for health autonomy in Colombia

Colombia depende de la importación de medicamentos, así como de gran parte de los materiales (principios activos y excipientes) requeridos para su elaboración; problemática que genera consecuencias sanitarias y macroeconómicas, las cuales se agudizan en el contexto de desindustrialización nacional y de disrupción tecnológica. De esta manera, se acepta que la disponibilidad y acceso a medicamentos y otras tecnologías sanitarias esenciales son un requisito fundamental para alcanzar la autonomía sanitaria de un país. Por lo tanto, resulta imprescindible coordinar esfuerzos entre diversos sectores sociales para desarrollar una agenda pública enfocada a la creación de condiciones que fortalezcan las capacidades científicas y tecnológicas de la industria farmacéutica local, y con ello, mejorar el suministro farmacéutico del país. En el presente documento se presentan conceptos teóricos y prácticos que deberían ser considerados en la definición y materialización de una política pública encaminada a fortalecer la industria farmacéutica y favorecer la autonomía sanitaria de Colombia.

Colombia has a notorious dependency on the importation of medicines, as well as a large part of the materials (active ingredients and excipients) required for their manufacture. This problem generates health and macroeconomic consequences, which are exacerbated in the context of national deindustrialization and technological disruption. In this way, it is accepted that the availability and access to medicines and other essential health technologies are a fundamental requirement to achieve the health autonomy of a country. Therefore, it is crucial to coordinate efforts between several social sectors to develop a public agenda focused on creating conditions that allow strengthening the scientific and technological capabilities of the local pharmaceutical industry, thereby, improving the country's pharmaceutical supply. This document presents conceptual and practical topics that should be considered to defining and materializing a public policy aimed at strengthening the local pharmaceutical industry and favoring Colombia's sanitary autonomy.

A tecnologia digital como mecanismo auxiliador no envelhecimento ativo no século XXI / Digital technology as an auxiliary mechanism for active aging in the 21st century

Objetivo: Analisar os efeitos benéficos do uso da tecnologia digital no envelhecimento ativo, considerando o contexto pós-pandemia Sars-Cov-2-covid-19. Além disso, pretende-se identificar as vantagens e desvantagens do uso dessas tecnologias pelas pessoas idosas no mundo contemporâneo. Método: estudo descritivo, tipo análise teórico reflexiva, desenvolvido a partir de duas questões norteadoras relacionados à temática, subsidiado por levantamento bibliográfico, considerando publicações pertinentes à temática, disponíveis nas bases de dados do Portal Regional da BVS, Portal de Periódicos Capes, SciELO e Pubmeb. por meio dos descritores controlados DECS /MeSH. Resultados: as TIC's estão desempenhando um papel crucial na vida das pessoas idosas, melhorando a comunicação, promovendo a saúde, facilitando o aprendizado e proporcionando um acesso mais fácil à informação e aos cuidados médicos. Conclusão: a tecnologia digital é um mecanismo auxiliador no envelhecimento ativo; quando bem implementado pode trazer mais vantagens do que desvantagens.(AU)

Objective: To analyze the beneficial effects of digital technology usage in active aging, considering the post-Sars-Cov-2-covid-19 pandemic context. Additionally, the aim is to identify the advantages and disadvantages of older individuals using these technologies in the contemporary world. Method: A descriptive study, specifically a theoretical reflective analysis, developed based on two guiding questions related to the theme. The study was supported by a literature review, considering publications relevant to the topic available in the databases of the Regional Portal of BVS, Capes Periodicals Portal, SciELO, and Pubmeb, using controlled descriptors such as DECS/MeSH. Results: Information and communication technologies (ICTs) are playing a crucial role in the lives of older individuals, enhancing communication, promoting health, facilitating learning, and providing easier access to information and medical care. Conclusion: Digital technology serves as an auxiliary mechanism in active aging; when well implemented, it can bring more advantages than disadvantages.(AU)

Objetivo: Analizar los efectos beneficiosos del uso de la tecnología digital en el envejecimiento activo, considerando el contexto post-pandemia de Sars-Cov-2-covid-19. Además, se pretende identificar las ventajas y desventajas del uso de estas tecnologías por parte de las personas mayores em mundo contemporáneo. Método: Estudio descriptivo, tipo análisis teórico reflexivo, desarrollado a partir de dos preguntas orientadoras relacionadas con el tema, respaldado por revisión bibliográfica que considera publicaciones pertinentes disponibles en las bases de datos del Portal Regional de BVS, Portal de Periódicos Capes, SciELO y Pubmeb, mediante descriptores controlados DECS/MeSH. Resultados: tecnologías de la información y la comunicación (TIC) desempeñan un papel crucial en la vida de las personas mayores, mejorando la comunicación, promoviendo la salud, facilitando aprendizaje y proporcionando acceso fácil a información y atención médica. Conclusión: La tecnología digital es un mecanismo auxiliar en el envejecimiento activo cuando se implementa adecuadamente puede aportar más ventajas que desventajas.(AU)

Study on the Relationship Between the Number of Adverse Drug Reactions of Essential Drugs and Visits: Based on Vector Autoregressive Model.

Objective: To analyse the relationship between the adverse drug reactions (ADRs) of essential drugs and visits, based on the recorded annual increase in ADRs associated with essential medicines in China, to provide a reliable theoretical basis for further analysis and optimization of the safety of essential drugs. Methods: The data of adverse reactions of essential drugs in China from 2011 to 2020, time series analysis was conducted, and vector autoregressive (VAR) model was established. The relationship between the number of ADRs and visits was explored empirically through Granger causality test, impulse response function and variance decomposition. Results: There was a long-term cointegration relationship and one-way causality between the number of visits and ADRs caused by essential medicines. In the initial stage, the ADR response to the number of visits increased sharply, but with an increase in the number of lag periods, the impact remained basically stable, even showing a slight decreasing trend. Conclusion: The number of visits impacts ADRs caused by essential medicines, but this impact remains basically stable after reaching a certain level.

Access to Essential Medicines for Diabetes Care: Availability, Price, and Affordability in Central Ethiopia.

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. 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 5mg, metformin 500mg) and two blood pressure-lowering medications (nifedipine 20mg and hydrochlorothiazide 25mg) 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, respectively. 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. Conclusion: There are big gaps in availability and affordability of EMs used for diabetes in central Ethiopia. Relevant stakeholders should work to improve access to EMs.

Cost-minimization analysis of escitalopram, fluoxetine, and amitriptyline in the treatment of depression.

INTRODUCTION: Escitalopram, fluoxetine, and amitriptyline are the drugs commonly used in the treatment of depression. The pharmacoeconomic evaluation of these drugs becomes relevant as they are prescribed for a long period of time, and depression causes a significant economic burden. The cost-minimization study would contribute to bringing down the annual treatment costs, leading to better medication adherence and ultimately better patient outcomes. MATERIALS AND METHODS: All drug prices are mentioned in Indian National Rupee (INR). All expenses are based on 2022 pricing. No cost discounting was used because all expenditures were calculated over a year. We considered hypothetical scenarios where the patient was prescribed the lowest possible dose for depression, an equivalent antidepressant dose, a defined daily dose, and the maximum acceptable therapeutic dose for depression. RESULTS: Annual average treatment costs of amitriptyline, escitalopram, and fluoxetine in patients with depression at baseline with equivalent dosing as mono-drug therapy were 2765.53, 2914.78, and 1422.72 rupees (INR), respectively. Savings were high when the patient was shifted to fluoxetine from either escitalopram or amitriptyline. The savings from switching to fluoxetine were 50.66% and 56.42% from escitalopram and amitriptyline, respectively. CONCLUSION: The choice of an antidepressant depends on multiple aspects, among which the cost of treatment plays a crucial role. Among the drugs compared, fluoxetine seems to offer greater value for money. The study emphasizes that selective serotonin reuptake inhibitors are the most commonly prescribed antidepressants not only because of their favorable pharmacological profile but also because of their affordability.

"'It is very difficult in this business if you want to have a good conscience': pharmaceutical governance and on-the-ground ethical labor in Ghana": a letter to editors.

Establishing effective pharmaceutical governance is a challenge for government agencies, private enterprises, and professionals working on the ground, demanding complex ethical decisions from the actors involved, especially in a lower-middle-income country like Ghana. This letter aims to share the author's perspectives and additional considerations on the analyses of the reports in the paper "It is very difficult in this business if you want to have a good conscience": pharmaceutical governance and on-the-ground ethical labor in Ghana by Hampshire et al. The letter's authors discuss the need to advance universal health coverage in Ghana, the everyday ethics, and the disparities between the collective and individual moral consciousness of the participants, as well as other aspects of governance in the pharmaceutical sector.