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.

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.

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.

Política industrial farmacéutica, un requisito clave para la autonomía sanitaria de 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.

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.

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.

Assessment of prescription completeness and drug use pattern using WHO prescribing indicators in private community pharmacies in Addis Ababa: a cross-sectional study.

BACKGROUND: Healthcare systems in both developing and developed countries were not free from prescription errors. One of the effects of prescription errors is irrational prescribing. According to the estimation of the World Health Organization (WHO), greater than 50% of medicines are prescribed and dispensed irrationally. On the other hand, research on drug use patterns in the private healthcare sector is scarce. This study aimed to assess prescription Completeness and Drug use Pattern using WHO prescribing indicators in Private Community Pharmacies in Lemi-Kura sub-city. METHODS: Based on the WHO prescribing indicators, a retrospective cross-sectional technique was employed to examine the completeness and drug-prescription patterns. The study was conducted from April to May 2021. Prescriptions, kept for 1 year that was prescribed from March 2020 to March 2021, by private healthcare sectors, were analyzed. A systematic random sampling technique was employed to select prescriptions obtained from private health facilities. Data were analyzed using SPSS® version 26.0 software. RESULTS: Of a total of 1000 prescriptions, 1770 drugs were prescribed and the average number of drugs per prescription was 1.77. Prescriptions for two drugs account for 38% of these, while prescriptions for three drugs account for 15%. Age, sex, and card number were written on 99.0%, 99.2%, and 41.8% of prescriptions, respectively. The patient's name was written on every prescription. Even though the availability of other therapeutic information on the prescription made it appear greater, only 44.2% of prescriptions included the dosage form of medications. The generic name was used for the majority of the medications (67.8%). Furthermore, assuming that each prescription was for a single patient, 71% of patients received antibiotics, and 2% received injectable medicines. The National List of Essential Medicines-Ethiopia was used in 99.6% of the prescriptions. CONCLUSIONS: On the basis of the finding of this study, the prescribing and prescription completeness indicator showed deviation from the standard recommended by WHO. This situation could be critical since a similar pattern is reported from public healthcare sectors, which might imply the extent of non-adherence to WHO core drug use standards. Consequently, it could play a considerable role in increasing prescription errors in Ethiopia. Hence, in-service training for prescribers should be provided to improve adherence to basic prescription writing.

A national survey on registered products, availability, prices, and affordability of 100 essential medicines in community pharmacies across Sri Lanka.

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.

Access and use of WHO essential medicines in Italy.

Background: Many countries use the WHO Essential Medicines List (EML) as a guide for health policy choices to promote the efficient use of healthcare resources or adopt the concept of essential medicines (EMs) to develop their own national list of essential medicines. The aim of this study is to analyse the availability and use of medicines included in the 22nd WHO EML in Italy. Methods: Using the ATC code (5th level), a comparison was made between the medicines included in the WHO EML and those retrieved from the Italian Medicines Agency (AIFA) database. The availability (regulatory and reimbursement status) of EMs, as well as the market share in expenditure (million euros) and consumption [measured in WHO-defined daily doses (DDDs)], compared to all reimbursed medicines in 2021, were analysed. Results: In 2021, approximately 85.2% (n = 414) of medicines included in the WHO EML were commonly marketed in Italy. Of these, 396 EMs were fully reimbursed by the Italian National Healthcare Service (INHS), corresponding to 81.5% (396/486) of the WHO EML, while the remaining 18.5% (90/486) were neither authorised (n = 72) nor reimbursed (n = 18). The study found a low coverage for anti-parasitic, insecticides, and repellent products (ATC P) in addition to medicines for the genitourinary system and sex hormones (ATC G). Even though medicines on the WHO EML, including therapeutic alternatives, accounted for ~48.5% of the expenditure for medicines reimbursed by INHS, the list covered 74% of all national drug consumed. Novel high-cost therapies indicated in high-prevalence diseases and rare conditions, mostly antineoplastic and immune-modulating agents (ATC L) not included in the WHO EML, were also guaranteed. Conclusions: In Italy, high coverage of EMs was found. It was largely reimbursed by the INHS, even when compared to other European countries. Essential medicines represented a high percentage of the overall expenditure and consumption in Italy. The WHO EML could be an important tool to guide the health policy choices of high-income countries, although a more frequent update and easier access to information on rejected medicines are needed.

Accessibility crisis of essential medicines at Sudanese primary healthcare facilities: a cross-sectional drugs' dispensaries assessment and patients' perspectives.

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.

Estudo comparativo entre empresa farmacêutica global e instituição pública de produção e inovação em saúde / Comparative study between global pharmaceutical company and public institution of production and innovation in health

RESUMO O cenário tecnológico no campo da saúde é um fato alarmante, mormente no contexto provocado pela Covid-19. Nessa conjuntura, a Fundação Oswaldo Cruz, por meio da Unidade de Bio-Manguinhos, e o Butantan foram protagonistas para o acesso universal, dialogando com estratégicas internacionais. No adensamento da discussão estratégica para Instituições Públicas de Produção e Inovação em Saúde (Ippis), o uso de diretrizes da Avaliação de Tecnologias em Saúde destaca-se como via de mudança paradigmática para a introdução de tecnologias no Sistema Único de Saúde (SUS) alinhada à visão de inovação de futuro em saúde consonante às demandas nacionais. Este artigo, desenvolvido metodologicamente mediante pesquisas descritiva qualitativa, bibliográfica, documental e trabalho de campo, buscou traçar simetrias e assimetrias baseado nas experiências coletadas em empresa farmacêutica global e instituição de referência nacional pública do campo de incorporação tecnológica em saúde. Como resultados, são explicitados pontos-chave para o fortalecimento técnico e político do Complexo Econômico-Industrial da Saúde, por meio da revisão organizacional das Ippis quanto a aspectos de inovação e de gestão, culminado na promoção de melhorias na Política de ciência, tecnologia e inovação em resposta ao desafio da sustentabilidade, efetividade e acesso no SUS.

ABSTRACT The technological scenario in the field of health is an alarming fact, especially in the context caused by COVID-19. In this context, the Oswaldo Cruz Foundation, through the Bio-Manguinhos Unit, and the Butantan Institute were protagonists for universal access, dialoguing with international strategies. In the strategic discussion for Public Institutions of Production and Innovation in Health (IPPIS), the use of guidelines of the Technological Assessment in Health stands out as a way of paradigmatic change for the introduction of technologies in the Unified Health System (SUS) in line with the vision of future innovation in health in accordance with national demands. This article, methodologically developed through qualitative descriptive research, bibliographical, documentary and field work, sought to trace symmetries and asymmetries based on the experiences collected in a global pharmaceutical company and a public national reference institution in the field of technological incorporation in health. As a result, key points are explained for the technical and political strengthening of the Health Economic-Industrial Complex, through the organizational review of the IPPIS regarding innovation and management aspects, culminating in the promotion of improvements in the science, technology and innovation policy in response to the challenge of sustainability, effectiveness and access in the SUS.

Palliative Justice Post-COP27.

The climate crisis is a planetary existential threat, disproportionately affecting the poorest populations worldwide. People in low- and middle-income countries (LMICs) experience the most detrimental consequences of climate injustice, endangering their livelihoods, safety, overall wellbeing, and survival. Although the 2022 United Nations Climate Change Conference (COP27) put forth several internationally salient recommendations, the outcomes fall short to efficiently tackle the suffering that exists at the intersection of social and climate injustice. Individuals with serious illness living in LMICs have the highest burden of health-related suffering globally. In fact, more than 61 million people experience serious health-related suffering (SHS) each year that is amenable to palliative care. Despite this well-documented burden of SHS, an estimated 88-90% of palliative care need is unmet, the majority in LMICs. To equitably address suffering at individual, population, and planetary levels in LMICs, a palliative justice approach is crucial. The interplay of human and planetary suffering requires that current planetary health recommendations be expanded to incorporate a whole-person and whole-people perspective that recognizes the need for environmentally conscious and community-based research and policy initiatives. Conversely, palliative care efforts should incorporate planetary health considerations to ensure sustainability in capacity building and service provision. In sum, the optimal health of the planet will remain elusive until we can holistically recognize the value of relieving all suffering due to life-limiting conditions, as well as the value in preserving the natural resources of countries in which all people are born, live, age, suffer, die, and grieve.

An Assessment of the Availability of Essential Medicines in Gadag Taluk, Karnataka: A Study of Primary Health Centers.

Background Essential medicines are those that meet the priority healthcare needs of most of the population and are included in the 2030 Agenda for Sustainable Development. The national list of essential medicines should be tailored to the specific needs of each nation and should always be accessible at reasonable prices and with guaranteed quality. Methods A cross-sectional study was done to assess the availability of essential medicines in primary health centers (PHCs) in Gadag Taluk. The data for the assessment of availability was collected using a checklist, which was prepared after reviewing the Karnataka list of essential medicines, surgical items, and miscellaneous items from 2021 to 2022 for PHCs. The sampling design was a universal sample of all 15 PHCs, as per health management information system data, to assess the availability of essential medicine in PHCs. Results Results indicate that the availability of essential medicines in 15 PHCs in Gadag Taluk is 74.20%. The availability of anti-allergic drugs and drugs used in anaphylaxis was around 88%, whereas the availability of antidiabetic drugs and non-steroidal anti-inflammatory drugs was 86.88% and 86.66%, respectively. All other categories of drugs are available above 50%, except ophthalmic and ear, nose, and throat drugs. Conclusion The public sector should be strengthened by making sure that patients have access to free essential medicines and that essential medications are always available. This would help patients spend less money out of their own pockets and move India closer to achieving universal healthcare.

The price and affordability of essential medicines, progress and regional distribution in China: a systematic review.

Background: Essential medicine is a vital component to assure universal access to quality healthcare. However, the trend of affordability to essential medicines in China and its regional differences were not yet fully understood. This study aimed to systematically evaluate the price and affordability of essential medicines, their progress, and regional distribution in China in the last decades. Methods: We searched seven databases and three websites for potentially eligible studies from inception until March 2022. Studies on the price and affordability of essential medicines investigated in China were included. Median and interquartile range (IQR) was used to describe the price and affordability of essential medicines, and compared in three periods, before 2009, from 2009 to 2014, and from 2015 to 2019. Subgroup analysis was performed to examine the price and affordability by regions, health facilities, and ATC categories of medicines. The study was registered with PROSPERO (CRD42022310173). Results: A total of 65 studies including 11,639 health facilities investigated between 2006 and 2019 were included in this review. Median price ratios (MPR) and affordability of essential medicines were reported in 44 studies and 50 studies, respectively. The median MPRs of essential medicines in China was 1.59 (IQR: 5.39), with a tendency to rise first and then fall from 2006 to 2019. And the median affordability was equal to 0.88 (IQR: 2.58) days' wage of the lowest paid unskilled government worker, but steadily rose from 2006 to 2019. Subgroup analysis showed that the affordability in the western region (1.40, IQR: 2.88), urban area (0.95, IQR: 2.80), private sector (0.90, IQR: 2.30), of originator brands (OB) (2.90, IQR: 6.68), and antineoplastic and immunomodulating agents (5.68, IQR: 56.47) were worse than their counterparts. Conclusion: The prices of essential medicine were higher than international level, the overall affordability of essential medicines in China is acceptable but poor in the western region, for OB drugs and anti-cancer medicines. Further national essential medicine policies are needed to reduce regional disparities and improve the affordability of expensive drugs. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/#recordDetails.

Availability of essential medicines, progress and regional distribution in China: a systematic review and meta-analysis.

Background: Essential medicines are the backbone of healthcare and meet the priority healthcare needs of the population. However, approximately one-third of the global population does not have access to essential medicines. Although China formulated essential medicine policies in 2009, the progress of availability of essential medicines and regional variations remains unknown. Therefore, this study was conducted to evaluate the availability of essential medicines, their progress, and regional distribution in China in the last decade. Methods: We searched eight databases from their inception to February 2022, relevant websites, and reference lists of included studies. Two reviewers selected studies, extracted data, and evaluated the risk of bias independently. Meta-analyses were performed to quantify the availability of essential medicines, their progress, and regional distribution. Results: Overall 36 cross-sectional studies conducted from 2009 to 2019 were included, with regional data for 14 provinces. The availability of essential medicines in 2015-2019 [28.1%, 95% confidence interval (CI): 26.4-29.9%] was similar to that in 2009-2014 (29.4%, 95% CI: 27.5-31.3%); lower in the Western region (19.8%, 95% CI: 18.1-21.5%) than Eastern (33.8%, 95% CI: 31.6-36.1%) and Central region (34.5%, 95% CI: 30.6-38.5%); very low for 8 Anatomical Therapeutic Chemical (ATC) categories (57.1%), and low for 5 categories (35.7%) among all ATC groups. Conclusion: The availability of essential medicines in China is low compared with the World Health Organization goal, has not changed much in the last decade, is unequal across regions, and lacks data for half of provinces. For policy-making, the monitoring system of the availability of essential medicines is to be strengthened to enable long-term surveillance, especially in provinces where the data has been missing. Meanwhile, Joint efforts from all stakeholders are warranted to improve the availability of essential medicines in China toward the universal health coverage target. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=315267, identifier: PROSPERO CRD42022315267.

Variations in global prices of chemotherapy for childhood cancer: a descriptive analysis.

Background: The stark disparity in survival for children with cancer across the world has inspired a global call to expand chemotherapy access in low and middle income countries. Among the numerous barriers to success, a paucity of reliable information regarding chemotherapy pricing hinders the ability of governments and other key stakeholders to make informed budget decisions or negotiate lower medication prices. The aim of this study was to generate comparative price information on both individual chemotherapy agents and comprehensive treatment regimens for common childhood cancers using real-world data. Methods: Chemotherapy agents were selected based on their inclusion in the World Health Organization (WHO) Essential Medicines List for Children (EMLc) and their use in frontline regimens for the tracer cancer types prioritized by the WHO's Global Initiative for Childhood Cancer (GICC). Sources included IQVIA MIDAS data, obtained under license from IQVIA, and publicly available data from Management Sciences for Health (MSH). Data on chemotherapy prices and purchase volumes spanning 2012-2019 were aggregated according to WHO region and World Bank (WB) income classification. Cumulative chemotherapy prices for treatment regimens were compared across WB income classification. Findings: Data representing an estimated 1.1 billion doses of chemotherapy were obtained for 97 countries: 43 high income countries (HICs), 28 upper middle income countries (UMICs), and 26 low and lower middle income countries (LLMICs). Median drug prices in HICs were 0.9-20.4 times those of UMICs and 0.9-15.5 times those of LMICs. Regimen prices were generally higher for HICs, hematologic malignancies, non-adapted protocols, and higher risk stratification or stage, albeit with notable exceptions. Interpretation: This study represents the largest price analysis to date of chemotherapy agents used globally in childhood cancer therapy. The findings of this study form a basis for future cost-effectiveness analysis in pediatric cancer and should inform efforts of governments and stakeholders to negotiate drug prices and develop pooled purchasing strategies. Funding: NB received funding support from the American Lebanese Syrian Associated Charities and Cancer Center Support grant (CA21765) from the National Cancer Institute through the National Institutes of Health. TA received funding through the University of North Carolina Oncology K12 (K12CA120780) and the University Cancer Research Fund from the UNC Lineberger Comprehensive Cancer Center.

Innovative mechanisms of pre-marketing authorization access for rare diseases in Brazil: a case study of pabinafusp-alfa for mucopolysaccharidosis type II / Mecanismos inovadores de acesso pré-comercialização a tecnologias para doenças raras no Brasil: um estudo de caso de alfapabinafuspe para mucopolissacaridose tipo II

Patients with rare diseases frequently face unmet medical needs due to the high costs, lengthy development times, and slow approval processes for new treatments. This case study discusses innovative access alternatives for rare diseases in Brazil, focusing on early access to pabinafusp-alfa for mucopolysaccharidosis type II (MPS-II), a rare genetic lysosomal storage disease characterized by a deficiency of the enzyme iduronate-2-sulfatase. From September 2018 to March 2023, 20 Brazilian MPS-II patients received pabinafusp-alfa through a clinical research protocol. This enzyme replacement therapy (ERT) crosses the blood-brain barrier to address central nervous system manifestations unmet by existing treatments. Patients' participation in the clinical study resulted in an estimated BRL 65 million in cost savings for the public healthcare system compared to conventional ERT with idursulfase-alfa and potentially better clinical outcomes. The case study underscores the importance of innovative mechanisms in addressing patients' medical needs. Early access alternatives include: a) clinical study access, with execution/development aligned with healthcare managers and linked to future access strategies; b) regulatory-level risk-sharing, considering effectiveness uncertainties and the possibility of market withdrawal and/or reimbursement in case of negative results; and c) drug pre-delivery, with payment contingent on positive phase III clinical study outcomes. Although public-private partnerships in clinical research are underused, they could benefit all stakeholders by accelerating drug development, facilitating early patient access to innovative medicines, and generating healthcare system savings, particularly for rare diseases.

Pacientes com doenças raras frequentemente enfrentam necessidades médicas não atendidas devido aos altos custos, longos tempos de desenvolvimento e processos de aprovação lentos para novos tratamentos. Este estudo de caso discute alternativas inovadoras de acesso para doenças raras no Brasil, com foco no acesso precoce ao alfapabinafuspe para mucopolissacaridose tipo II (MPS-II), uma doença lisossômica de armazenamento genético rara, caracterizada por uma deficiência da enzima iduronato-2-sulfatase. De setembro de 2018 a março de 2023, 20 pacientes brasileiros com MPS-II receberam alfapabinafuspe por meio de pesquisa clínica. Essa terapia de reposição enzimática (TRE) atravessa a barreira hematoencefálica para tratar manifestações do sistema nervoso central não atendidas pelos tratamentos existentes. A participação dos pacientes no estudo clínico resultou em uma economia estimada de 65 milhões de reais para o sistema público de saúde, em comparação com a TRE convencional com idursulfase alfa, além de potencialmente melhores resultados clínicos. O estudo de caso destaca a importância de mecanismos inovadores no atendimento das necessidades médicas dos pacientes. As alternativas de acesso precoce incluem: a) acesso por meio de estudos clínicos, com execução/desenvolvimento alinhada aos gestores de saúde e vinculada a estratégias futuras de acesso; b) compartilhamento de risco em nível regulatório, considerando as incertezas de eficácia e a possibilidade de retirada do mercado e reembolso em caso de resultados negativos; e c) pré-entrega do medicamento, com pagamento condicionado aos resultados positivos do estudo clínico de fase III. Embora as parcerias público-privadas em pesquisa clínica sejam subutilizadas, elas poderiam beneficiar todas as partes interessadas ao acelerar o desenvolvimento de medicamentos, facilitar o acesso precoce dos pacientes a medicamentos inovadores e gerar economias para o sistema de saúde, especialmente para doenças raras.

Availability of Access, Watch, and Reserve groups of essential antibiotics: a cross-sectional survey.

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 15th August to 10th 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.

Outpatient pharmaceutical office: access to medicines in public health

Abstract We evaluated the implementation of the outpatient pharmaceutical office in a teaching hospital regarding the access to medicines available in the Unified Health System - SUS. This is a descriptive-analytical study, based on secondary data analysis of 735 appointments performed by the pharmacist from 2015 to 2017. Of the drugs prescribed to patients attended at the outpatient pharmacist office, 86.39% were listed in the National List of Essential Medicines - RENAME, of which 95.43% belonged to the Specialized Component of Pharmaceutical Assistance. Evaluating the patient's diagnosis against the inclusion criteria of the Clinical Protocols and Therapeutic Guidelines (PCDT), that the most frequent pharmaceutical interventions were: adequacy of the medication request documents (56.4%) and examination requests for pharmacotherapeutic follow up (28.5%). When the prescribed drugs were not included in RENAME/PCDT, the intervention was accepted in 90.3% of the proposals for exchange with available drug in SUS. Still, it was possible to refer the patient to primary care for renewal of continuity of treatment in 95.1% of cases. In conclusion, the role of the clinical pharmacist contributes to the resolution of untreated health problems by promoting access to medicines within the scope of SUS and their rational use in accordance with the PCDT.

Judicialização no acesso a medicamentos: análise das demandas judiciais no estado do Piauí, Brasil / Judicialization in access to medicines: analysis of lawsuits in the State of Piauí, Brazil

Resumo: Este trabalho objetivou analisar acórdãos de fornecimento de medicamentos pelo Estado no Tribunal de Justiça do Estado do Piauí (TJ-PI) entre 2018 e 2021. Foram analisados 209 acórdãos, tendo sido predominantes mandados de segurança (49%), concessão de liminar (95%), decisões favoráveis (93%), medicamentos do sistema nervoso (24,6%) e antineoplásicos (23,7%), transtornos mentais (13,4%) e neoplasias (9,8%). Os resultados e análises demonstram o dever do Estado em prover os medicamentos solicitados.

Abstract: This work aimed to analyze judgments on the supply of medicines by the State in the Court of Justice of the State of Piauí (TJ-PI) between 2018 and 2021. 209 judgments were analyzed, predominantly injunctions (49%); granting of an injunction (95%); favorable decisions (93%); nervous system drugs (24.6%) and antineoplastics (23.7%); mental disorders (13.4%) and neoplasms (9.8%). The results and analyses demonstrate the State's duty to provide the requested medication.