Access to cancer medicines deemed essential by oncologists in 82 countries: an international, cross-sectional survey.

BACKGROUND: The WHO Essential Medicines List (EML) identifies priority medicines that are most important to public health. Over time, the EML has included an increasing number of cancer medicines. We aimed to investigate whether the cancer medicines in the EML are aligned with the priority medicines of frontline oncologists worldwide, and the extent to which these medicines are accessible in routine clinical practice. METHODS: This international, cross-sectional survey was developed by investigators from a range of clinical practice settings across low-income to high-income countries, including members of the WHO Essential Medicines Cancer Working Group. A 28-question electronic survey was developed and disseminated to a global network of oncologists in 89 countries and regions by use of a hierarchical snowball method; each primary contact distributed the survey through their national and regional oncology associations or personal networks. The survey was open from Oct 15 to Dec 7, 2020. Fully qualified physicians who prescribe systemic anticancer therapy to adults were eligible to participate in the survey. The primary question asked respondents to select the ten cancer medicines that would provide the greatest public health benefit to their country; subsequent questions explored availability and cost of cancer medicines. Descriptive statistics were used to compare access to medicines between low-income and lower-middle-income countries, upper-middle-income countries, and high-income countries. FINDINGS: 87 country-level contacts and two regional networks were invited to participate in the survey; 46 (52%) accepted the invitation and distributed the survey. 1697 respondents opened the survey link; 423 were excluded as they did not answer the primary study question and 326 were excluded because of ineligibility. 948 eligible oncologists from 82 countries completed the survey (165 [17%] in low-income and lower-middle-income countries, 165 [17%] in upper-middle-income countries, and 618 [65%] in high-income countries). The most commonly selected medicines were doxorubicin (by 499 [53%] of 948 respondents), cisplatin (by 470 [50%]), paclitaxel (by 423 [45%]), pembrolizumab (by 414 [44%]), trastuzumab (by 402 [42%]), carboplatin (by 390 [41%]), and 5-fluorouracil (by 386 [41%]). Of the 20 most frequently selected high-priority cancer medicines, 19 (95%) are currently on the WHO EML; 12 (60%) were cytotoxic agents and 13 (65%) were granted US Food and Drug Administration regulatory approval before 2000. The proportion of respondents indicating universal availability of each top 20 medication was 9-54% in low-income and lower-middle-income countries, 13-90% in upper-middle-income countries, and 68-94% in high-income countries. The risk of catastrophic expenditure (spending >40% of total consumption net of spending on food) was more common in low-income and lower-middle-income countries, with 13-68% of respondents indicating a substantial risk of catastrophic expenditures for each of the top 20 medications in lower-middle-income countries versus 2-41% of respondents in upper-middle-income countries and 0-9% in high-income countries. INTERPRETATION: These data demonstrate major barriers in access to core cancer medicines worldwide. These findings challenge the feasibility of adding additional expensive cancer medicines to the EML. There is an urgent need for global and country-level policy action to ensure patients with cancer globally have access to high priority medicines. FUNDING: None.

Increasing access to quality anticancer medicines in low- and middle-income countries: the experience of Uganda.

Cancer is one of the leading causes of death with 9.6 million deaths registered in 2018, of which 70% occur in Africa, Asia and Central and South America, the low-and middle-income countries (LMICs). The global annual expenditure on anticancer medicines increased from $96 billion in 2013 to $133 billion in 2017. This growth rate is several folds that of newly diagnosed cancer cases and therefore estimated to reach up to $200 billion by 2022. The Uganda Cancer Institute, Uganda's national referral cancer center, has increased access to cancer medicines through an efficient and cost-saving procurement system. The system has achieved cost savings of more than USD 2,000,000 on a total of 37 of 42 essential cancer medicines. This has resulted in 85.8% availability superseding the WHO's 80% target. All selected products were procured from manufacturers with stringent regulatory authority approval or a proven track record of quality products.

Pharmaceutical procurement among public sector procurers in CARICOM / Compras farmacéuticas por parte de organismos del sector público de CARICOM / Aquisição de produtos farmacêuticos por compradores do setor público da CARICOM

ABSTRACT Objective. To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. Methods. An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. Results. The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. Conclusions. The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

RESUMEN Objetivo. Revisar los múltiples aspectos de los medicamentos en los mercados de compras y los proveedores de CARICOM, como la ubicación de la sede del fabricante, el historial de regulación, el tipo (patentado versus genérico); la proporción de medicamentos esenciales de la Organización Mundial de la Salud (OMS); y los medicamentos comprados más caros. Métodos. Se analizó información sobre la compra por parte de determinados organismos de CARICOM. La información procedía de cuatro listas de organismos del sector público que realizan las compras, que se consiguieron en función de su disponibilidad pública o de los datos distribuidos por los organismos del sector público que realizan las compras. Los análisis estaban basados en los parámetros disponibles o derivados de estos datos. Resultados. La mayoría de los productos proviene de fabricantes radicados en América del Norte y Europa (entre 63% y 67%). El porcentaje de medicamentos que se compra de empresas genéricas oscila entre 60% y 87%; y de 25% a 50% de los medicamentos que se compran están en la Lista de Medicamentos Esenciales de la OMS. Hay una gran divergencia de precios entre los medicamentos comprados más caros. Conclusiones. En el análisis se han encontrado vulnerabilidades y oportunidades con respecto a la situación de las compras de medicamentos de los Estados de CARICOM, especialmente en cuanto a la calidad y al uso racional de los medicamentos. Este análisis representa una línea de base que los gobiernos u otros interesados directos pueden utilizar en el futuro.

RESUMO Objetivo. Examinar vários aspectos relacionados aos mercados e fornecedores de produtos farmacêuticos da CARICOM, incluindo a localização da sede do laboratório fabricante, histórico regulatório e tipo de produtos (inovadores versus genéricos); proporção de medicamentos adquiridos que constam da relação de medicamentos essenciais da Organização Mundial da Saúde (OMS); e medicamentos mais caros comprados. Métodos. Foi realizada uma análise de informação sobre compras feitas por compradores selecionados da CARICOM. Quatro listas de compras do setor público foram obtidas com informação de acesso público ou compartilhada pelos compradores. As análises foram feitas com base em parâmetros disponíveis ou inferidos a partir dos dados. Resultados. A maioria dos produtos farmacêuticos é proveniente de laboratórios com sedes na América do Norte e Europa (63%-67%). Do total, 60%-87% dos medicamentos adquiridos são de laboratórios de produtos genéricos e 25%-50% constam da relação de medicamentos essenciais da OMS. Existe uma ampla variação nos preços dos medicamentos mais caros comprados. Conclusões. Foram identificadas fragilidades e oportunidades na situação de compras dos países da CARICOM, em particular relacionadas à qualidade dos produtos e ao uso racional dos medicamentos. Esta análise serve de referência a ser usada futuramente pelos governos e outras partes interessadas.

Use of drugs for gastrointestinal disorders: evidence from National Survey on Access, Use and Promotion of Rational Use of Medicines.

Objective To estimate the prevalence of use of drugs to treat gastrointestinal disorders, according to demographic, socioeconomic, and health characteristics of the Brazilian population. Methods This is a population-based survey that interviewed individuals residing in cities of the five regions in Brazil. The study sample was composed of 32,348 individuals aged 20 or more years. The profile of use of drugs for gastrointestinal disorders was evaluated considering the variables sex, age, healthcare plan, region, and number of chronic diseases. We also analyzed the frequency of individuals who declared using other drugs, besides those already employed for treatment of gastrointestinal disorders. Additionally, the estimated frequencies of the drug classes used were determined. Results The prevalence of use of drugs for gastrointestinal disorders in Brazil was 6.9% (95% confidence interval - 6.4-7.6), higher in females, among persons aged over 60 years, in those who had a private healthcare insurance, and presented with two or more chronic diseases. It was noted that 42.9% of the aged who used drugs for gastrointestinal disorders were also on polypharmacy. As to the classes of drugs, 82% corresponded to drugs for the food tract and metabolism, particularly proton pumps inhibitors. Conclusion The use of drugs for treatment of gastrointestinal disorders was significant among women and elderly. In this age group, consumption may be linked to gastric protection due to polypharmacy. This study is an unprecedented opportunity to observe the self-reported consumption profile of these drugs in Brazil and, therefore, could subsidize strategies to promote their rational use.

Lista de medicamentos esenciales para el manejo de pacientes que ingresan a unidades de cuidados intensivos con sospecha o diagnóstico confirmado de COVID-19 / List of essential drugs for the management of patients admitted to intensive care units with suspected or confirmed diagnosis of COVID-19

En el transcurso de la pandemia de COVID-19, numerosos países, de ingresos bajos, medianos y alto, han visto agotadas sus reservas de medicamentos esenciales necesarios para el manejo de los pacientes con COVID-19 en las unidades de cuidados intensivos (UCI). El plan de preparación para emergencias sanitarias de los países requiere incluir una lista de medicamentos esenciales y otros dispositivos médicos necesarios en las UCI para afrontar emergencias sanitarias. La lista de medicamentos esenciales para el manejo de pacientes que ingresan a unidades de cuidados intensivos con sospecha o diagnóstico confirmado de COVID-19 es un documento de orientación fundamental que ayuda a los sistemas de salud de los países a priorizar los medicamentos esenciales que deben estar ampliamente disponibles y ser asequibles para manejar los pacientes en las UCI durante las situaciones de emergencia sanitaria, en este caso con sospecha o diagnóstico confirmado de COVID-19. Está dirigida a las autoridades sanitaras y a los encargados del manejo del sistema de salud de los países. Esta lista incluye fundamentalmente los medicamentos considerados esenciales para el manejo de los cuadros clínicos que con se observan con mayor frecuencia en pacientes hospitalizados en UCI a causa de una infección por SARS-CoV-2. No se incluyen la mayoría de los medicamentos que comúnmente se encuentran en las UCI para el manejo de otras patologías, comorbilidades o la estabilización del paciente (p. ej., insulina o antihipertensivos), salvo aquellos que pueden requerirse para el tratamiento o apoyo (p. ej., bloqueantes neuromusculares o anestésicos) de las dolencias generadas por la infección. Tampoco se incluyen medicamentos específicos para el tratamiento de la infección por SARS-CoV-2, puesto que no existe, por el momento, evidencia científica de alta calidad que avale su uso, salvo en el contexto de ensayos clínicos controlados. Un equipo de expertos en el tema realizó una búsqueda de información sobre la atención de pacientes en UCI durante la pandemia de COVID-19, en Medline (a través de PubMed), Cochrane, Tripdatabase, Epistemonikos y en buscadores generales de internet (Google). Se identificaron también revisiones o guías generadas por ministerios de Salud de varios países de la Región de las Américas, la Organización Mundial de la Salud (OMS), la Organización Panamericana de la Salud (OPS), el Instituto Nacional de Salud y Excelencia Clínica (NICE) de Reino Unido, los Centros para el Control y la Prevención de Enfermedades (CDC) de Estados Unidos y los Institutos Nacionales de Salud (NIH) de Estados Unidos.

A survey of nongovernmental organizations on their use of WHO's prequalification programme.

OBJECTIVE: To obtain the perspectives of some small- and medium-sized organizations on the World Health Organization (WHO) prequalification programme for medicines and to ascertain organizations' unmet needs. METHODS: We conducted an exploratory, qualitative study in 2018 among 17 representatives of 15 small- and medium-sized Belgian and non-Belgian organizations who purchase medicines for humanitarian, development or public programmes in low- and middle-income countries. We used semi-structured interviews to obtain respondents' views and experiences of using WHO prequalification guidance when procuring medicines. We identified emerging themes and formulated recommendations about the activities of the WHO Prequalification Team. FINDINGS: Most respondents suggested expanding prequalification to essential antibiotics, particularly paediatric formulations; and insulin, antihypertensives and cancer treatments. Respondents were concerned about irregular availability of WHO-prequalified medicines in the marketplace and sometimes high prices of prequalified products. Small organizations, in particular, had difficulties negotiating low-volume purchases. Organizations working in primary health care and hospitals seldom referred to the prequalified lists. CONCLUSION: We recommend that the WHO-prequalified products be expanded to include essential antibiotics and medicines for noncommunicable diseases. The WHO Prequalification Team could require prequalified manufacturers to make publicly available the details of their authorized distributors and facilitate a process of harmonization of quality assurance policies across all donors. Prequalification of distributors and procurement agencies could help create more transparent and stringent mechanisms. We urge WHO Member States and funders to sustain support for the WHO Prequalification Team, which remains important for the fulfilment of universal health coverage.

Availability, prices, and affordability of selected essential cancer medicines in a middle-income country - the case of Mexico.

BACKGROUND: More alternatives have become available for the diagnosis and treatment of cancer in low- and middle-income countries. Because of increasing demands, governments are now facing a problem of limited affordability and availability of essential cancer medicines. Yet, precise information about the access to these medicines is limited, and the methodology is not very well developed. We assessed the availability and affordability of essential cancer medicines in Mexico, and compared their prices against those in other countries of the region. METHODS: We surveyed 21 public hospitals and 19 private pharmacies in 8 states of Mexico. Data were collected on the availability and prices of 49 essential cancer medicines. Prices were compared against those in Chile, Peru, Brazil, Colombia and PAHO's Strategic Fund. RESULTS: Of the various medicines, mean availability in public and private sector outlets was 61.2 and 67.5%, respectively. In the public sector, medicines covered by the public health insurance "People's Health Insurance" were more available. Only seven (public sector) and five (private sector) out of the 49 medicines were considered affordable. Public sector procurement prices were 41% lower than in other countries of the region. CONCLUSIONS: The availability of essential cancer medicines, in the public and private sector, falls below World Health Organization's 80% target. The affordability remains suboptimal as well. A national health insurance scheme could serve as a mechanism to improve access to cancer medicines in the public sector. Comprehensive pricing policies are warranted to improve the affordability of cancer medicines in the private sector.

Legal demands of the tiotropium bromide for treatment of chronic obstructive pulmonary disease and their financial impact for the State of Paraná, Brazil.

OBJECTIVE: To analyze the legal demands of tiotropium bromide to treat chronic obstructive pulmonary disease. METHODS: We included secondary data from the pharmaceutical care management systems made available by the Paraná State Drug Center. RESULTS: Public interest civil action and ordinary procedures, among others, were the most common used by the patients to obtain the medicine. Two Health Centers in Paraná (Londrina and Umuarama) concentrated more than 50% of the actions. The most common specialty of physicians who prescribed (33.8%) was pulmonology. There is a small financial impact of tiotropium bromide on general costs with medicines of the Paraná State Drug Center. However, a significant individual financial impact was observed because one unit of the medicine represents 38% of the Brazilian minimum wage. CONCLUSION: Our study highlights the need of incorporating this medicine in the class of long-acting anticholinergic bronchodilator in the Brazilian public health system.

Decision space and participation of primary healthcare facility managers in the Ideal Clinic Realisation and Maintenance programme in two South African provinces.

In South Africa, the introduction of a national health insurance (NHI) system is the most prominent health sector reform planned to achieve universal health coverage in the country. Primary health care (PHC) is the foundation of the proposed NHI system. This study draws on policy implementation theory and Bossert's notion of decision space to analyse PHC facility managers' decision space and their participation in the implementation of the Ideal Clinic Realisation and Maintenance (ICRM) programme. We conducted a cross-sectional survey among 127 PHC facility managers in two districts in Gauteng and Mpumalanga provinces. A self-administered questionnaire elicited socio-demographic information, the PHC managers' participation in the conceptualization and implementation of the ICRM programme, their decision space and an optional open-ended question for further comments. We obtained a 100% response rate. The study found that PHC facility managers reported lack of involvement in the conceptualization of the ICRM programme, high levels of participation in implementation [mean score 5.77 (SD ±0.90), and overall decision space mean score of 2.54 (SD ±0.34)]. However, 17 and 21% of participants reported narrow decision space on the critical areas of the availability of essential medicines and on basic resuscitation equipment respectively. The qualitative data revealed the unintended negative consequences of striving for 'ideal clinic status', namely that of creating an illusion of compliance with the ICRM standards. The study findings suggest the need for greater investment in the health workforce, special efforts to involve frontline managers and staff in health reforms, as well as provision of adequate resources, and an enabling practice environment.

Use of drugs for gastrointestinal disorders: evidence from National Survey on Access, Use and Promotion of Rational Use of Medicines / Utilização de medicamentos para distúrbios gastrintestinais: evidências da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos

ABSTRACT Objective To estimate the prevalence of use of drugs to treat gastrointestinal disorders, according to demographic, socioeconomic, and health characteristics of the Brazilian population. Methods This is a population-based survey that interviewed individuals residing in cities of the five regions in Brazil. The study sample was composed of 32,348 individuals aged 20 or more years. The profile of use of drugs for gastrointestinal disorders was evaluated considering the variables sex, age, healthcare plan, region, and number of chronic diseases. We also analyzed the frequency of individuals who declared using other drugs, besides those already employed for treatment of gastrointestinal disorders. Additionally, the estimated frequencies of the drug classes used were determined. Results The prevalence of use of drugs for gastrointestinal disorders in Brazil was 6.9% (95% confidence interval − 6.4-7.6), higher in females, among persons aged over 60 years, in those who had a private healthcare insurance, and presented with two or more chronic diseases. It was noted that 42.9% of the aged who used drugs for gastrointestinal disorders were also on polypharmacy. As to the classes of drugs, 82% corresponded to drugs for the food tract and metabolism, particularly proton pumps inhibitors. Conclusion The use of drugs for treatment of gastrointestinal disorders was significant among women and elderly. In this age group, consumption may be linked to gastric protection due to polypharmacy. This study is an unprecedented opportunity to observe the self-reported consumption profile of these drugs in Brazil and, therefore, could subsidize strategies to promote their rational use.

RESUMO Objetivo Estimar a prevalência de utilização de medicamentos para o tratamento de distúrbios gastrintestinais, segundo características demográficas, socioeconômicas e de saúde da população brasileira. Métodos Trata-se de inquérito de base populacional, que entrevistou indivíduos residentes em municípios das cinco regiões do Brasil. A amostra deste estudo foi composta por 32.348 indivíduos de 20 anos ou mais de idade. Foi avaliado o perfil de utilização de medicamentos para distúrbios gastrintestinais entre as variáveis sexo, idade, plano de saúde, região e número de doenças crônicas. Analisou-se a frequência de indivíduos que declararam utilizar outros medicamentos, além daqueles já utilizados para tratamento de distúrbios gastrintestinais. Além disso, foram estimadas as frequências das classes medicamentosas utilizadas. Resultados A prevalência de utilização de medicamentos para distúrbios gastrintestinais no Brasil foi de 6,9% (intervalo de confiança de 95% − 6,4-7,6), sendo maior no sexo feminino, entre pessoas acima de 60 anos de idade, naqueles que possuíam plano privado de saúde e tinham duas ou mais doenças crônicas. Observou-se que 42,9% dos idosos que utilizaram medicamentos para distúrbios gastrintestinais também eram polimedicados. Em relação às classes medicamentosas, 82% correspondiam a medicamentos para o trato alimentar e metabolismo, destacando os inibidores da bomba de prótons. Conclusão A utilização de medicamentos para tratamento de distúrbios gastrintestinais foi significativa entre mulheres e idosos. Nesta faixa etária, o consumo pode estar vinculado à proteção gástrica causada por polimedicação. Este estudo representa oportunidade inédita para observar o perfil de consumo autorreferido desses medicamentos no Brasil e pode, portanto, subsidiar estratégias para promoção de seu uso racional.

Legal demands of the tiotropium bromide for treatment of chronic obstructive pulmonary disease and their financial impact for the State of Paraná, Brazil / Demandas judiciais do uso de brometo tiotrópio para o tratamento da doença pulmonar obstrutiva crônica e o impacto financeiro para o Estado do Paraná, Brasil

ABSTRACT Objective To analyze the legal demands of tiotropium bromide to treat chronic obstructive pulmonary disease. Methods We included secondary data from the pharmaceutical care management systems made available by the Paraná State Drug Center. Results Public interest civil action and ordinary procedures, among others, were the most common used by the patients to obtain the medicine. Two Health Centers in Paraná (Londrina and Umuarama) concentrated more than 50% of the actions. The most common specialty of physicians who prescribed (33.8%) was pulmonology. There is a small financial impact of tiotropium bromide on general costs with medicines of the Paraná State Drug Center. However, a significant individual financial impact was observed because one unit of the medicine represents 38% of the Brazilian minimum wage. Conclusion Our study highlights the need of incorporating this medicine in the class of long-acting anticholinergic bronchodilator in the Brazilian public health system.

RESUMO Objetivo Analisar as demandas judiciais do brometo de tiotrópio para tratar a doença pulmonar obstrutiva crônica. Métodos Foram considerados dados secundários dos sistemas gerenciais de assistência farmacêutica, disponibilizados pelo Centro de Medicamentos do Paraná. Resultados Ações civis públicas e ações ordinárias, de procedimento comum, entre outras, foram as mais praticadas pelos pacientes para obter o medicamento. Duas Regionais de Saúde do Paraná (Londrina e Umuarama) concentraram mais de 50% das ações. Quanto à especialidade dos médicos prescritores, 33,8% eram pneumologistas. Verificou-se discreto impacto financeiro do brometo de tiotrópio nos gastos gerais com medicamentos pelo Centro de Medicamentos do Paraná. Entretanto, também houve relevante impacto financeiro individual, pois uma unidade do medicamento consome 38% do salário mínimo. Conclusão O estudo aponta para a necessidade de incorporação deste medicamento da classe broncodilatadores anticolinérgicos de longa duração, no Sistema Único de Saúde.

Availability, Price and Affordability of Anticancer Medicines: Evidence from Two Cross-Sectional Surveys in the Jiangsu Province, China.

OBJECTIVES: With the increasing incidence of cancer, poor access to affordable anticancer medicines has been a serious public health problem in China. To help address this issue, we assessed the availability, price and affordability of pharmacotherapy for cancer in public hospitals in the Jiangsu Province, China. METHODS: In 2012 and 2016, anticancer medicine availability and price information in the capital and five other cities was collected. A total of six cancer care hospitals, 26 tertiary general hospitals and 28 secondary general hospitals were sampled, using an adaptation of the World Health Organization/Health Action International methodology. Data was collected for the anticancer medicines in stock at the time of the surveys. Prices were expressed as inflation-adjusted median unit prices (MUPs). Medicine was affordable if the overall cost of all the prescribed anticancer medicines was less than 20% of the household's capacity to pay. We used generalized estimating equations to estimate the significance of differences in availability from 2012 to 2016 and the Wilcoxon rank test to estimate the significance of differences in MUPs. Multivariate logistic regression was computed to measure predictors of affordability. RESULTS: From 2012 to 2016 there was a significant decrease in the mean availability of originator brands (OBs) (from 7.79% to 5.71%, p = 0.012) and lowest-priced generics (LPGs) (36.29% to 32.67%, p = 0.009). The mean availability of anticancer medicines in secondary general hospitals was significantly lower than the cancer care, as well as in tertiary general hospitals. The MUPs of OBs (difference: -21.29%, p < 0.01) and their LPGs (-22.63%, p < 0.01) decreased significantly from 2012 to 2016. The OBs (16.67%) of all the anticancer medicines were found to be less affordable than LPGs (34.62% for urban residents and 30.77% for rural residents); their affordability varied among the different income regions. From 2012 to 2016, the proportion of LPGs with low availability and low affordability dropped from 30.77% to 19.23% in urban areas and 34.62% to 26.92% in rural areas, respectively. Generic substitution and medicine covered by basic medical insurance are factors facilitating affordability. CONCLUSION: There were concerning decreases in the availability of anticancer medicines in 2016 from already low availability in 2012. Anticancer medicines were more affordable for the patients in high-income regions than the patients in low-income regions. Governments should consider using their bargaining power to reduce procurement prices and abolish taxes on anticancer medicines. Policy should focus on the special health insurance plan for low-income patients with cancer. The goal of drug policy should ensure that first-line generic drugs are available for cancer patients and preferentially prescribed.

A multidisciplinary review of the policy, intellectual property rights, and international trade environment for access and affordability to essential cancer medications.

In 2015, the World Health Organization (WHO) Expert Committee approved the addition of 16 cancer medicines to the WHO Model List of Essential Medicines (EML), bringing the total number of cancer medicines on the list to 46. This change represented the first major revision to the EML oncology section in recent history and reinforces international recognition of the need to ensure access and affordability for cancer treatments. Importantly, many low and middle-income countries rely on the EML, as well as the children's EML, as a guide to establish national formularies, and moreover use these lists as tools to negotiate medicine pricing. However, EML inclusion is only one component that impacts cancer treatment access. More specifically, factors such as intellectual property rights and international trade agreements can interact with EML inclusion, drug pricing, and accessibility. To better understand this dynamic, we conducted an interdisciplinary review of the patent status of EML cancer medicines compared to other EML noncommunicable disease medicines using the 17th, 18th, 19th, 20th, and 21st editions of the list. We also explored the interaction of intellectual property rights with the international trade regime and how trade agreements can and do impact cancer treatment access and affordability. Based on this analysis, we conclude that patent status is simply one factor in the complex international environment of health systems, IPR policies, and trade regimes and that aligning these oftentimes disparate interests will require shared global governance across the cancer care continuum.

Comparative Analysis of Private Retail Community Pharmacies' Participation in the National Health Insurance Scheme of Nigeria and Ghana: Implications for Access to Essential Medicines.

BACKGROUND: Frequent stock-out of drugs in the public hospitals causes National Health Insurance Scheme (NHIS) enrollees to purchase most of their medicines out-of-pocket in community pharmacies, thereby imposing financial constraints on them against the main objective of the scheme. The objectives of this study were to determine and compare the level of participation of private retail community pharmacies (PRCPs) in the NHIS of Nigeria and Ghana, to describe their spatial distribution, and to highlight from literature major factors that would influence the participation of these pharmacies in the scheme. METHODS: PRCPs data were collected from the Nigerian NHIS active secondary healthcare providers list of 1st July 2017 and the Ghanaian NHIS active providers online list of 2018. PRCPs densities at the national levels were calculated from last published national coverage data for each country. RESULTS: The total number of PRCP accredited by NHIS of both Nigeria and Ghana is 964(639[66.3% versus 325[33.7%]). NHIS accredited PRCPs densities for Nigeria and Ghana were 1 PRCP per 9, 390 enrollees and 1 PRCP per 33, 108 enrollees respectively. Across the Nigerian States, it was noted that Lagos State has the highest proportion (21.4%, n = 137) of community pharmacy participation in the scheme whereas, in Ghan, Greater Accra Region has the highest participation (34.2%, n = 111). CONCLUSION: This study revealed low participation of PRCPs and skewed spatial distribution between urban and rural areas of both countries, although there was higher participation of these pharmacies in Nigeria due to Nigerian lower NHIS coverage data compared to Ghana.

Equity analysis of resource distribution for the Popular Pharmacy Program.

OBJECTIVE: To analyze the regional allocation of the resources from the Brazilian Popular Pharmacy Program, taking into account the relative availability of the program and the potential needs of the region. METHODS: Data from the National Health Survey of the Annual Report of Social Information and the administrative database of the program were used to create a non-parametric indicator of coverage using multiple data envelopment analysis technique. This indicator considers the relative availability of the program, taking into account equal access to equal needs (equity based on regional needs). The analysis of this indicator shows if the regions that most need pharmaceutical assistance are those that receive more resources from the Brazilian Popular Pharmacy Program. RESULTS: The states belonging to the richest regions of the country, Southeast and South, present wider relative coverage of the Brazilian Popular Pharmacy Program compared to poorer localities. In addition, the inequalities observed between locations are better explained by inefficiency in the transfer of resources to the basic component of pharmaceutical care than by the Brazilian Popular Pharmacy Program itself. According to the model, a 43.76% increase in the transfer to the basic component of pharmaceutical care would be required in order to improve equity, whereas the increase required by the Brazilian Popular Pharmacy Program is equivalent to 22.71%. CONCLUSIONS: Although the Brazilian Popular Pharmacy Program seeks to reduce the socioeconomic inequalities observed in access to pharmaceutical care, which integrates health care services, regional disparities in access to medicine persist. These regional differences are attributed mostly to allocation failures and problems in managing the conventional pharmaceutical care cycle provided through SUS pharmacies.

Added therapeutic value of new drugs approved in Brazil from 2004 to 2016.

This study aimed to assess the level of therapeutic innovation of new drugs approved in Brazil over 13 years and whether they met public health needs. Comparative descriptive analysis of therapeutic value assessments performed by the Brazilian Chamber of Drug Market Regulation (CMED) and the French drug bulletin Prescrire for new drugs licensed in Brazil, from January 1st 2004 to December 31st 2016. The extent to which new drugs met public health needs was examined by: checking inclusions into government-funded drug lists and/or clinical guidelines; comparing Anatomical Therapeutic Chemical Classification (ATC) codes and drug indications with the list of conditions contributing the most to the national disease burden; and assessing new medicines aimed to treat neglected diseases. 253 new drugs were approved. Antineoplastics, immunossupressants, antidiabetics and antivirals were the most frequent. Thirty-three (14%) out of 236 drugs assessed by the Brazilian chamber and sixteen (8.2%) out of 195 assessed by the French bulletin Prescrire were considered innovative. Thirty-six drugs (14.2%) were selected for coverage by the Brazilian Unified National Health System (SUS), seven of which were therapeutically innovative, and none were aimed to treat neglected disease. About 1/3 of the drugs approved aimed to treat conditions among the top contributors to Brazil's disease burden. Few therapeutically innovative drugs entered the Brazilian market, from which only a small proportion was approved to be covered by the SUS. Our findings suggest a divergence between public health needs, research & development (R&D) and drug licensing procedures.

Availability of Essential Medicines for Pediatric Oncology in Armenia

Background: One of the main contributors in low survival rate in LMIC is the lack of availability of cancer medications for curative, supportive and palliative care. In many developing countries access to cytotoxic medicine is a major challenge. The information about the availability of essential medicines for pediatric cancer in the country is not known. The main objective of this study was to determine whether the medications used during the treatment of pediatric cancer are available in Armenia. Methods: In summer 2016 we conducted a survey in the 3 main pharmacies in Yerevan, which import pediatric cancer medications to Armenia to evaluate whether medications used during cancer treatment are officially registered and available in the country. In addition, the information on official registration was cross-checked with the Ministry of Health of the Republic of Armenia (MOH). Simultaneously, detailed information about the drugs, on type of produced drug company, doses and price intervals was confined from the price lists of the national drug importer companies. Results: The survey included 64 agents in three classes of medication: anti-neoplastics, anti-microbials, and drugs used in supportive care. All of these medications were included in the recent version of the WHO model list of essential medicines. From 30 anti-neoplastic medications on the essential medicines list 22 (73%) were officially registered in Armenia; from 19 anti-microbial drugs all were registered except caspofungin and from 15 supportive care agents 13 (87%) were registered. From registered anti-neoplastic drugs 18% and from antimicrobial drugs 33% were not available in the drug stores. Conclusion: This study showed that not all the drugs from the SIOP PODC Essential Medication list for pediatric oncology are officially registered and available in Armenia, and effective drug regulation focusing on the childhood cancer care medicine is needed for improving the situation in the country.

Chemotherapy and Supportive Care Agents as Essential Medicines for Children With Cancer.

In resource-rich countries, 5-year survival rates for children with cancer approach 85%. This impressive statistic is largely the result of integrating research with clinical care. At the core of this endeavor are multiagent combination chemotherapy and supportive care agents (CASCA). Most CASCAs belong to the class of sterile injectable drugs, which make up the backbone of many proven and life-saving pediatric oncology regimens. There are few if any alternative agents available to treat most life-threatening childhood cancers. In the United States, shortages of CASCAs are now commonplace. The consequences of drug shortages are far reaching. Beyond the economic costs, these shortages directly affect patients' lives, and this is especially true for children with cancer. Drug shortages in general and shortages of CASCAs specifically result in increased medication errors, delayed administration of life-saving therapy, inferior outcomes, and patient deaths. One way to mitigate drug shortages is to adopt an essential medicines list and ensure that these medications remain in adequate supply at all times. We argue for creation of a CASCA-specific essential medicines list for childhood cancer and provide ethical and policy-based reasoning for this approach. We recognize that such a call has implications beyond pediatric cancer, in that children with other serious disease should have an equal claim to access to guaranteed evidence-based medicines. We provide these arguments as an example of what should be claimed for medical indications that are deemed essential to preserve life and function.