Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.

When Knowledge Is Not Enough: Applying a Behavioral Design Approach to Improve Fever Case Management in Nigeria.

BACKGROUND: We sought to encourage health care providers to adhere to national malaria case management guidelines. This requires them to conduct malaria parasite tests for every patient presenting with a fever and provide malaria treatment only to those who test positive for malaria. Our goal was to make it easier for providers to follow guidelines by addressing drivers of nonadherence uncovered through facility observations and interviews with staff and clients. IMPLEMENTATION AND MONITORING: The case management interventions were piloted in 12 public health facilities in Akwa Ibom, Kebbi, and Nasarawa states in Nigeria between October and December 2019. Participating facilities included 1 hospital and 3 primary health centers in each state. Relevant changes included the following: (1) providers at each facility participated in facilitated discussions to correct misconceptions about the reliability of malaria test kits; (2) testing procedures were integrated into existing triage systems; (3) treatment algorithms were integrated into medical record forms; (4) providers were issued pictorial brochures outlining danger signs to share with clients, together with instructions for when to seek further care; and (5) a process was created for facilities to monitor their own adherence to guidelines. LESSONS LEARNED: The lessons learned include: (1) disentangling the drivers of behavior allows for more targeted solutions, (2) solutions that streamline processes for overburdened providers allow them to redirect their attention and efforts where they can be most impactful, and (3) changing staff perceptions of workplace norms can support a holistic and sustained approach to behavior change.

Molecular Detection of Leishmania (Leishmania) mexicana in Sandflies from the State of Yucatan, Mexico.

Background: Leishmaniases are a group of vector-borne zoonotic diseases of public health relevance within the tropical and subtropical regions of the world. The state of Yucatan is a vulnerable and receptive area to localized cutaneous leishmaniasis (LCL) due to its proximity to the high-transmission endemic states of Campeche and Quintana Roo. Autochthonous cases of LCL caused by Leishmania (Leishmania) mexicana have been documented in the state, showing a geographical expansion of the disease. Materials and Methods: Using CO2-supplemented Centers for Disease Control and Prevention light traps and Shannon traps, we captured anthropophilic sandflies in the surroundings of a locality with recent records of autochthonous cases of LCL. Sandflies carrying Leishmania DNA were evidenced using PCR. Results: A total of 140 Phlebotominae (Diptera: Psychodidae) females of four species were captured: Lutzomyia (Tricholateralis) cruciata (Coquillett), Psathyromyia (Psathyromyia) shannoni (Dyar), Lutzomyia (Lutzomyia) longipalpis (Lutz and Neiva), and Dampfomyia (Coromyia) deleoni (Fairchild and Hertig). Molecular results showed that 6.1% (95% confidence interval [CI] = 2.3-12.9%) of Lu. cruciata and 43.8% (95% CI = 19.8-70.1%) of Pa. shannoni showed evidence of carrying L. (L.) mexicana DNA. Conclusion: We provide evidence of anthropophilic sandflies carrying L. mexicana DNA in a municipality with recorded autochthonous cases of LCL caused by this parasite species in the state of Yucatan, suggesting the emergence of new focus of LCL in Mexico.

Working With Lesbian, Gay, Bisexual, and Transgender Clients: Occupational Therapy Practitioners' Knowledge, Skills, and Attitudes.

IMPORTANCE: A lack of health care provider knowledge and training has been identified as one factor that contributes to health disparities for sexual and gender minority (SGM) populations. OBJECTIVE: To explore occupational therapy practitioners' self-reported knowledge about, clinical preparedness for, and attitudes toward working with lesbian, gay, bisexual, and transgender (LGBT) clients. DESIGN: Online survey of occupational therapy practitioners. PARTICIPANTS AND SETTING: Respondents were recruited by means of snowball sampling through social media groups, state occupational therapy association websites, and emails. Surveys were posted to electronic occupational therapy social media sites. MEASURES: Knowledge, clinical preparedness, and attitudes were measured using the Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale (LGBT-DOCSS). Information about demographic characteristics, education, and workplace was also collected. RESULTS: Five hundred eighty-nine occupational therapy practitioners responded to the survey. Degree level (master's vs. bachelor's or less), continuing education (minimum 1-2 hr of LGBT-specific training), practice setting (mental health), minority sexual orientation, and having a close friend or family member who identifies as SGM were associated with higher mean scores on the LGBT-DOCSS. Higher religiosity and frequency of religious practice were associated with lower scores on knowledge and attitudinal awareness. CONCLUSIONS AND RELEVANCE: Occupational therapy practitioners often care for clients from backgrounds and cultures that differ from their own. Identifying gaps in education and opportunities for fostering LGBT-positive attitudes can facilitate the development of programs to improve practice with LGBT clients and help measure the effectiveness of such programs. What This Article Adds: This study provides evidence that a basic level of continuing education can improve occupational therapy practitioners' knowledge of and skills for working with LGBT populations and highlights the need to examine and change structural biases.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

Transparency of data on the value chain of medicines in Argentina, Brazil, and Colombia.

Introduction: The transparency of data on the value chain of medicines is crucial for the study and monitoring of the pharmaceutical system. These data may impact medicine pricing negotiations, contribute to patient access to pharmaceutical products, and strengthen health systems. Objective: This study analyzed the national strategies to ensure the transparency of data from medicine cost development to marketing in Argentina, Brazil, and Colombia. Method: A descriptive study was carried out by searching databases, reports, documents, and scientific articles published between January and August 2022 related to rules on transparency and databases, including 1) marketing authorization; 2) pricing; 3) intellectual property; 4) clinical trials; 5) research and development (R&D); and 6) health technology assessment (HTA) of selected biopharmaceuticals. Results: Transparency data, rules, and information are not uniform. The infostructures (organizational capacity for collecting and distributing information) regarding the pharmaceutical value chain in these three countries face limitations in appropriate measures to publicly share data and evidence, including pre-clinical data, clinical data, and costs. None of the countries require transparency about data on research and development costs. All three countries present similar publicization of data on marketing authorization and intellectual property, with some differences. The significant limitations in Argentina include the absence of formal price regulation and data on the volume of medicine purchased and respective amounts paid. Among the three countries, Brazil showed a higher degree of information transparency, perhaps due to the legal regulation that guarantees citizens access to information of public interest. Brazil also stands out in terms of the public availability of HTA reports and pricing, in addition to the highest volume of information. In contrast, Colombia has in place a decree that allows 5 years of trial data exclusivity for new medicines, an act contrary to data transparency. Despite the different stages of transparency, no country has evidenced a robust use of these data in public policy decision-making. Conclusion: The results reinforce the presence of information asymmetry between stakeholders, data fragmentation, data gaps and overlap, and difficulty in comparing available data across the three countries and the use of these data nationally to produce evidence.

Costs of insecticide-treated bed net distribution systems in sub-Saharan Africa.

BACKGROUND: Insecticide-treated nets (ITNs) are one of the most cost-effective measures for preventing malaria. The World Health Organization recommends both large-scale mass distribution campaigns and continuous distributions (CD) as part of a multifaceted strategy to achieve and sustain universal access to ITNs. A combination of these strategies has been effective for scaling up ITN access. For policy makers to make informed decisions on how to efficiently implement CD or combined strategies, information on the costs and cost-effectiveness of these delivery systems is necessary, but relatively few published studies of the cost continuous distribution systems exist. METHODS: To address the gap in continuous distribution cost data, four types of delivery systems-CD through antenatal care services (ANC) and the expanded programme on immunization (EPI) (Ghana, Mali, and mainland Tanzania), CD through schools (Ghana and mainland Tanzania), and a combined community/health facility-based distribution (Zanzibar, Tanzania), as well as mass distributions (Mali)-were costed. Data on costs were collected retrospectively from financial and operational records, stakeholder interviews, and resource use surveys. RESULTS: Overall, from a full provider perspective, mass distributions and continuous systems delivered ITNs at overlapping economic costs per net distributed (mass distributions: 4.37-4.61 USD, CD channels: 3.56-9.90 USD), with two of the school-based systems and the mass distributions at the lower end of this range. From the perspective of international donors, the costs of the CD systems were, for the most part, less costly than the mass distributions (mass distributions: 4.34-4.55 USD, Ghana and Tanzania 2017 school-based: 3.30-3.69 USD, health facility-based: 3.90-4.55 USD, combined community/health facility 4.55 USD). The 2015 school-based distribution (7.30 USD) and 2016 health facility-based distribution (6.52 USD) programmes in Tanzania were an exception. Mass distributions were more heavily financed by donors, while CD relied more extensively on domestic resource contributions. CONCLUSIONS: These results suggest that CD strategies can continue to deliver nets at a comparable cost to mass distributions, especially from the perspective of the donor.

Systematic review and meta-analysis of the cost and cost-effectiveness of distributing insecticide-treated nets for the prevention of malaria.

Insecticide-treated nets are one of two core vector control interventions recommended by the World Health Organization for deployment in malaria-endemic regions around the world, especially sub-Saharan Africa. Although there are many factors that influence the type of distribution strategy chosen, among the most important considerations for the type of distribution strategy chosen is cost, both in terms of total expenditure required and in terms of relative cost-effectiveness. This research attempted to inform these decisions by conducting a systematic review and meta-analysis of the literature on the cost and cost-effectiveness of ITN distribution. The analysis compared the relative cost and cost-effectiveness of distribution strategies. Findings suggest that mass campaigns have lower average distribution costs per net compared with continuous/health facility distribution or sale/vouchers, although the relationship between distribution channel and cost were not statistically significant in the multivariate regression models. Continuous/health facility distribution channels were found to be more cost-effective than mass campaigns for averting DALYs, death, and cases of malaria. Those who design and budget for malaria programs should base decisions about distribution channels more on operational and epidemiological considerations than on cost per net, as the costs per net between distribution channels are not statistically different.

Judicialización del acceso a medicamentos en el contexto Suramericano / Judicialization of access to medicines in the South American context

Los gobiernos suramericanos reconocen el acceso a medicamentos como parte del derecho de sus poblaciones a la salud y al bienestar. Tanto la vida como la salud entendidas como derechos sociales implican esfuerzos de los sistemas de salud para garantizar las mejores condiciones de manera equitativa y colectiva, sin restricciones de acceso, y manteniendo su sostenibilidad. El fenómeno, conocido como "judicialización del acceso a los medicamentos" se ha tornado una vía alternativa a los mecanismos establecidos por el sistema de salud en la región, generando preocupaciones relacionadas con la contradicción entre los esfuerzos de los sistemas de salud y las determinaciones judiciales. Este artículo presenta una revisión sistemática el tema en la región, a partir de las bases de datos Scopus, PubMed y Lilacs. Muchos de los casos informados describen demandas individuales sin que se hayan generado rutas colectivas, cuyas sentencias pudieran involucrar a grupos más numerosos de personas, generar jurisprudencia para próximos abordajes similares, e impactar en el diseño o implementación de políticas públicas. Según el principio de universalidad, la judicialización de medicamentos es una estrategia útil en tanto mantenga el equilibrio entre la garantía del derecho a la salud, el bienestar colectivo y la mejor disposición de los recursos en salud. Desde la perspectiva jurídica queda una gran inquietud sin resolver en cuanto al rol de las diversas instancias con las que cuentan los países para garantizar derechos fundamentales y su articulación con otras instancias como tribunales y autoridades administrativas.

South American governments recognize access to medicines as part of the right of their popu-lations to health and welfare. Both, life and health understood as social rights imply efforts of the health systems to guarantee the best conditions in an equitable and collective way, without restrictions to access, and maintaining their sustainability. The so-called "judiciali-zation of access to medicines" has become an alternative path to the mechanisms established by the health systems in the region, generating concerns related to the contradiction between the efforts of health systems and judicial determinations. This article presents a systematic review on the subject in the region, based on Scopus, PubMed and Lilacs databases. Many of the cases reported describe individual claims that have not generated collective routes, whose sentences could involve more numerous groups of people; generate jurisprudence for similar approaches, and impact on the design and implementation of public policies. Under the principle of universality, the judicialization of medicines is a useful strategy insofar as it maintains the balance between the guarantees of the right to health, collective welfare and the best disposition of the health resources. From a legal perspective, there is still an unresolved concern regarding the role of the various entities that are available to countries to guarantee fundamental rights and its articulation with other bodies such as courts and administrative authorities.

Medicine Shortages: Gaps Between Countries and Global Perspectives.

Introduction: Over the last decade, global health policies and different research areas have focused on the relevance and impact of medicine shortages. Published studies suggest there have been difficulties with access to medicines since the beginning of the 20th century, and there have been advances in our understanding and management of the problem since then. However, in view of global and regional health care concerns with shortages, we believe this phenomenon needs to be characterized and described more fully regarding the types of medicines affected, possible causes, and potential strategies to address these. The aim of this scoping review was to identify, compare if possible, and characterize the recent literature regarding the situation of medicines shortages between countries, and provide different perspectives, including a global context and national approaches. Methodology: A scoping study presented as a narrative review of the situation and findings principally based on published articles. Results: Based on the reported cases in the literature, a typology of medicines shortage and supply interruption episodes and their causes were proposed; national approaches to notify and manage the medicines shortages cases were described and classified by update frequency; principal differences between market and supply chain management perspectives of the situation were identified and global and countries' perspectives were described. Conclusion: Policy makers require solutions that prevent those cases in which the population's health is affected by episodes of medicine shortages and/or interruption in the supply chain. There is also a need to generate a glossary related to logistics management and the availability of medicines which will be useful to understand and overcome shortages. In addition, recognize that potential solutions are not only related with actions linked to research, development and innovation, but much wider. Overall, we believe this article can act as a basis for future discussions in this important area.

Age and gender trends in insecticide-treated net use in sub-Saharan Africa: a multi-country analysis.

BACKGROUND: The degree to which insecticide-treated net (ITN) supply accounts for age and gender disparities in ITN use among household members is unknown. This study explores the role of household ITN supply in the variation in ITN use among household members in sub-Saharan Africa. METHODS: Data was from Malaria Indicator Surveys or Demographic and Health Surveys collected between 2011 and 2016 from 29 countries in sub-Saharan Africa. The main outcome was ITN use the previous night. Other key variables included ITN supply (nets/household members), age and gender of household members. Analytical methods included logistic regressions and meta-regression. RESULTS: Across countries, the median (range) of the percentage of households with enough ITNs was 30.7% (8.5-62.0%). Crude analysis showed a sinusoidal pattern in ITN use across age groups of household members, peaking at 0-4 years and again around 30-40 years and dipping among people between 5-14 and 50+ years. This sinusoidal pattern was more pronounced in households with not enough ITNs compared to those with enough ITNs. ITN use tended to be higher in females than males in households with not enough ITNs while use was comparable among females and males in households with enough ITNs. After adjusting for wealth quintile, residence and region, among households with not enough ITNs in all countries, the odds of ITN use were consistently higher among children under 5 years and non-pregnant women 15-49 years. Meta-regressions showed that across all countries, the mean adjusted odds ratio (aOR) of ITN use among children under 5 years, pregnant and non-pregnant women aged 15-49 years and people 50 years and above was significantly higher than among men aged 15-49 years. Among these household members, the relationship was attenuated when there were enough ITNs in the household (dropping 0.26-0.59 points) after adjusting for geographical zone, household ITN supply, population ITN access, and ITN use:access ratio. There was no significant difference in mean aOR of ITN use among school-aged children compared to men aged 15-49 years, regardless of household ITN supply. CONCLUSIONS: This study demonstrated that having enough ITNs in the household increases level of use and decreases existing disparities between age and gender groups. ITN distribution via mass campaigns and continuous distribution channels should be enhanced as needed to ensure that households have enough ITNs for all members, including men and school-aged children.

Drug utilization study of two generic antibiotics in a tertiary hospital in Bogotá

Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs. Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá. Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed. Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem. Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors.

Utilización de dos antibióticos genéricos en un hospital de tercer nivel en Bogotá / Drug utilization study of two generic antibiotics in a tertiary hospital in Bogotá

Resumen Introducción. La política farmacéutica de Colombia establece la necesidad de intensificar la investigación en farmacoepidemiología a nivel nacional, especialmente en el caso de los antibióticos. Objetivo. Aportar información farmacoepidemiológica en cuanto a la efectividad, las condiciones de uso y la seguridad de la cefepima y el meropenem genéricos en un hospital de alta complejidad en Bogotá. Materiales y métodos. Se hizo un estudio descriptivo, longitudinal y retrospectivo sobre la utilización de estos medicamentos. Los datos se recolectaron de todas las historias clínicas en las cuales se registraba el uso de cefepima y meropenem. Resultados. Se incluyeron 82 pacientes tratados con cefepima y 91 con meropenem. La mayoría de ellos había estado internada en servicios diferentes a la unidad de cuidados intensivos (59,8 % con cefepima y 52,7 % con meropenem). El 21,9 % de los tratados con cefepima y el 49 % de los tratados con meropenem, tuvieron consulta con un infectólogo, en tanto que en 47 % de los primeros y en 78 % de los segundos, se hizo cultivo o antibiograma. Las condiciones más frecuentemente tratadas con cefepima fueron las infecciones de vías respiratorias (32,5 %) y, con meropenem, las infecciones genitourinarias (34,8 %). Las tasas de éxito terapéutico fueron de 61,7 % para la cefepima y de 63,0 % para el meropenem. Conclusiones. Este estudio aporta información sobre el desempeño terapéutico de dos antibióticos genéricos de uso hospitalario. No hubo reportes de falla terapéutica durante el periodo de estudio. En los casos en que no hubo respuesta al tratamiento, las causas frecuentes fueron las alteraciones farmacocinéticas, las condiciones clínicas desfavorables y la elección inadecuada del tratamiento antimicrobiano.

Abstract Introduction: The Colombian national pharmaceutical policy establishes as a strategy the generation of greater pharmaco-epidemiological research at the national level, especially in the case of antibiotic drugs. Objective: To provide local pharmaco-epidemiological evidence regarding the effectiveness, conditions of use and safety of generic meropenem and cefepime in a tertiary hospital in Bogotá. Materials and methods: We conducted a descriptive, longitudinal and retrospective drug utilization study. The data were collected from the medical histories of all the patients who had cefepime or meropenem prescribed. Results: We included 82 patients treated with cefepime and 91 treated with meropenem in the study. Most of the patients were in services different from the intensive care unit (taking cefepime: 59.8%, and meropenem: 52.7%). Only 21.9% of the patients treated with cefepime and 49% of those treated with meropenem were seen by an infectious disease specialist. The antibiogram was performed for 47% and 60% of the patients treated with cefepime and meropenem, respectively. The most frequent indication for cefepime were respiratory infections and for meropenem, genitourinary ones. Therapeutic success rates were 61.7% for cefepime and 63.0% for meropenem. Conclusions: This study contributes evidence regarding the therapeutic performance of two generic antibiotics used in tertiary hospitals. There were no reports of therapeutic failure during the study period. In the cases of non-response, pharmacokinetic alterations, unfavorable clinical conditions, and inappropriate choice of antimicrobial treatment were identified as frequent factors.

Design, Implementation, and Evaluation of a School Insecticide-Treated Net Distribution Program in Cross River State, Nigeria.

BACKGROUND: In 2013, the World Health Organization recommended distribution through schools, health facilities, community health workers, and mass campaigns to maintain coverage with insecticide-treated nets (ITNs). We piloted school distribution in 3 local government areas (LGAs) of Cross River State, Nigeria. METHODS: From January to March 2011, all 3 study sites participated in a mass ITN campaign. Baseline data were collected in June 2012 (N=753 households) and school distribution began afterward. One ITN per student was distributed to 4 grades once a year in public schools. Obubra LGA distributed ITNs in 2012, 2013, and 2014 and Ogoja LGA in 2013 and 2014 while Ikom LGA served as a comparison site. Pregnant women in all sites were eligible to receive ITNs through standard antenatal care (ANC). Endline survey data (N=1,450 households) were collected in March 2014. Data on ITN ownership, population access to an ITN, and ITN use were gathered and analyzed. Statistical analysis used contingency tables and chi-squared tests for univariate analysis, and a concentration index was calculated to assess equity in ITN ownership. RESULTS: Between baseline and endline, household ownership of at least 1 ITN increased in the intervention sites, from 50% (95% confidence interval [CI]: 44.7, 54.3) to 76% (95% CI: 71.2, 81.0) in Ogoja and from 51% (95% CI: 35.3, 66.7) to 78% (95% CI: 71.5, 83.1) in Obubra, as did population access to ITN, from 36% (95% CI: 32.0, 39.5) to 53% (95% CI: 48.0, 58.0) in Ogoja and from 34% (95% CI: 23.2, 45.6) to 55% in Obubra (95% CI: 48.4, 60.9). In contrast, ITN ownership declined in the comparison site, from 64% (95% CI: 56.4, 70.8) to 43% (95% CI: 37.4, 49.4), as did population ITN access, from 47% (95% CI: 40.0, 53.7) to 26% (95% CI: 21.9, 29.9). Ownership of school ITNs was nearly as equitable (concentration index 0.06 [95% CI: 0.02, 0.11]) as for campaign ITNs (-0.03 [95% CI: -0.08, 0.02]), and there was no significant oversupply or undersupply among households with ITNs. Schools were the most common source of ITNs at endline and very few households (<2%) had nets from both school and ANC. CONCLUSION: ITN distribution through schools and ANC provide complementary reach and can play an effective role in achieving and maintaining universal coverage. More research is needed to evaluate the cost-effectiveness of such continuous distribution channels in combination with, or as a potential replacement for, subsequent mass campaigns.

Impact of a 15-month multi-channel continuous distribution pilot on ITN ownership and access in Eastern Region, Ghana.

BACKGROUND: Insecticide-treated nets are a key intervention for malaria prevention. While mass distribution can rapidly scale up ITN coverage, multiple channels may be needed to sustain high levels of ITN access and ownership. In Ghana's Eastern Region, a continuous ITN distribution pilot, started in October 2012, 18-24 months after a mass campaign. The pilot distributed ITNs through antenatal care services (ANC), child welfare clinic services (CWC) through the Expanded Programme on Immunization, and to students in two classes of primary schools. METHODS: ITN ownership and access were evaluated through two cross-sectional surveys, conducted at baseline in April 2012, 11-15 months after the mass campaign, and at endline in December 2013, after 1 year of continuous distribution. A representative sample was obtained using a multi-stage cluster sampling design. Household heads were interviewed using a structured questionnaire. RESULTS: Household ownership of at least one ITN was 91.3% (95% CI 88.8-93.9) at baseline and was not statistically significant at endline 18 months later at 88.3% (95% CI 84.9-91.0) (p = 0.10). Ownership of at least 1 ITN per two people significantly decreased from 51.3% (95% CI 47.1-55.4) to 40.2% (95% CI 36.4-44.6) (p < 0.01). Population access to an ITN within the household also significantly decreased from 74.5% (95% CI 71.2-77.7) at baseline to 66.4% (95% CI 62.9-69.9) at endline (p < 0.01). The concentration index score for any CD channel was slightly positive (0.10; 95% CI 0.04-0.15). CONCLUSION: Thirty-one months after the mass campaign, the 15 months of continuous distribution activities had maintained levels of household ownership at least one ITN, but household ownership of one ITN for every two people and population access to ITN had declined. Ownership and access were higher with the CD programme than without. However, the number of ITNs delivered via ANC, CWC and two primary school classes were insufficient to sustain coverage targets. Future programmes should implement continuous distribution strategies fully within 1 year after a campaign or widen eligibility criteria (such as increase the number of classes) during the first year of implementation to make up for programme delays.

[Proposed model for managing drugs used for unregistered indications in Colombia]. / Propuesta de un modelo de gestión de medicamentos en indicaciones no registradas en Colombia.

The use of drugs for unregistered indications, known as "off-label" use, is a practice that creates problems of rational use and access when other options are not available. Health systems should address this situation, particularly in connection with decisions concerning coverage, while trying to minimize health risks and clearly define the roles and responsibilities of the parties involved. Colombia's Ministry of Health and Social Protection (MinSalud), together with the National University of Colombia and national experts, developed a proposal for a model for managing drugs being used for unregistered indications (off-label) and their potential reimbursement with public resources, taking into account international practices and country characteristics. The management model is non-punitive and is geared toward promoting the rational use of these drugs so that barriers to access are reduced whenever their use is supported by solid scientific evidence. The model addresses patient safeguards in the bioethical domain and the roles and responsibilities of the prescriber and government entities.

Propuesta de un modelo de gestión de medicamentos en indicaciones no registradas en Colombia / Proposed model for managing drugs used for unregistered indications in Colombia

El uso de medicamentos en indicaciones no registradas (INR), conocido como uso “off-label”, es una práctica que genera problemas de uso racional y de acceso cuando no existen alternativas disponibles. Los sistemas de salud deben gestionar esta realidad, sobre todo cuando se trata de decisiones de cobertura, buscando minimizar los riesgos para la salud y estableciendo de forma clara los papeles y las responsabilidades de los agentes involucrados. El Ministerio de Salud y Protección Social de Colombia (MinSalud), junto con con la Universidad Nacional de Colombia y expertos nacionales, diseñaron una propuesta de modelo de gestión del uso de medicamentos en indicaciones no registradas (off-label) y su potencial reembolso con recursos públicos, teniendo en cuenta prácticas internacionales y la realidad nacional. El modelo de gestión es no punitivo y está orientado a la promoción del uso racional de estos medicamentos, de forma que se reduzcan las barreras al acceso cuando su uso está respaldado por pruebas cientificas de calidad. El modelo incorpora elementos de garantías bioéticas del paciente, los papeles y las responsabilidades del prescriptor y de las entidades de gobierno.

The use of drugs for unregistered indications, known as “off-label” use, is a practice that creates problems of rational use and access when other options are not available. Health systems should address this situation, particularly in connection with decisions concerning coverage, while trying to minimize health risks and clearly define the roles and responsibilities of the parties involved. Colombia's Ministry of Health and Social Protection (MinSalud), together with the National University of Colombia and national experts, developed a proposal for a model for managing drugs being used for unregistered indications (off-label) and their potential reimbursement with public resources, taking into account international practices and country characteristics. The management model is non-punitive and is geared toward promoting the rational use of these drugs so that barriers to access are reduced whenever their use is supported by solid scientific evidence. The model addresses patient safeguards in the bioethical domain and the roles and responsibilities of the prescriber and government entities.

Multi-country comparison of delivery strategies for mass campaigns to achieve universal coverage with insecticide-treated nets: what works best?

BACKGROUND: The use of insecticide-treated nets (ITNs) is widely recognized as one of the main interventions to prevent malaria. High ITN coverage is needed to reduce transmission. Mass distribution campaigns are the fastest way to rapidly scale up ITN coverage. However, the best strategy to distribute ITNs to ensure household coverage targets are met is still under debate. This paper presents results from 14 post-campaign surveys in five African countries to assess whether the campaign strategy used had any effect on distribution outcome. METHODS: Data from 13,901 households and 14 campaigns from Ghana, Nigeria, Senegal, South Sudan and Uganda, were obtained through representative cross-sectional questionnaire surveys, conducted three to 16 months after ITN distribution. All evaluations used a multi-stage sampling approach and similar methods for data collection. Key outcomes examined were the proportion of households having received a net from the campaign and the proportion of households with one net for every two people. RESULTS: Household registration rates proved to be the most important determinant of a household receiving any net from the campaign (adjusted odds ratio [OR] 74.8; 95 % confidence interval [CI]: 55.3-101.1) or had enough ITNs for all household members (adjusted OR 19.1; 95 % CI: 55.34-101.05). Factors that positively influenced registration were larger household size (adjusted OR 1.7; 95 % CI: 1.5-2.1) and families with children under five (adjusted OR 1.4; 95 % CI: 1.2-1.6). Urban residence was negatively associated with receipt of a net from the campaign (adjusted OR 0.73; 95 % CI: 0.58-0.92). Registration was equitable in most campaigns except for Uganda and South Sudan, where the poorest wealth quintiles were less likely to have been reached. After adjusting for other factors, delivery strategy (house-to-house vs. fixed point) and distribution approach (integrated versus stand-alone) did not show a systematic impact on registration or owning any ITN. Campaigns that used a universal coverage allocation strategy were more effective in increasing the proportion of households with enough ITNs than campaigns that used a fixed number of ITNs. Registering based on counting usual sleeping spaces resulted in higher levels of households with one net per two people among those receiving any campaign net (adjusted OR 1.6; 95 % CI: 1.07-2.48) than campaigns that registered based on the number of household members. CONCLUSION: All of the campaigns, irrespective of strategy, successfully increased ownership of at least one ITN. Delivery method and distribution approach were not associated with receipt of at least one ITN from the campaign. Rather, the key determining factor for receipt of at least one ITN from the campaign was a successful registration process, which depends on the ability of community volunteers to reach households during the exercise. Universal coverage campaigns, especially those that used a sleeping space allocation strategy, were more effective in increasing the proportion of households with enough ITNs. Maximizing registration completeness and using a universal coverage allocation strategy are therefore likely to improve campaign outcomes.

Systematic review of cross-national drug utilization studies in Latin America: methods and comparability.

PURPOSE: We systematically review the cross-national drug utilization studies performed in Latin America (LA) in order to analyze the methods applied and assess the validity of the data to ensure the comparability. METHODS: A systematic search in Medline, Embase, and BIREME was performed. Drug utilization studies including LA countries and comparing drug exposure data on volume were included. The data validity was judged independently by two authors as having low, medium, high, or unclear risk of bias. RESULTS: Out of 1191 articles, 25 were kept for full text reading. Finally, five studies were selected. Eight different Latin American countries were involved in the comparisons. The selected studies analyzed wholesale data from a private research company collecting information from the private healthcare sector. In three studies, a high risk of bias in the extrapolation method applied was identified. In one study, a risk of data collection bias was detected. The most frequent limitation detected by the original authors was related to the unavailability of information from the public sector in LA. CONCLUSION: Drug utilization studies comparing data cross-nationally are scarce in LA. In general, validity of the comparisons is hampered by a potential risk of extrapolation bias given the lack of available data on drug consumption from the public healthcare sector. Setting up systems to remediate this situation is a future challenge for researchers and (supra)national authorities in the region.

Impact of a behaviour change communication programme on net durability in eastern Uganda.

BACKGROUND: The importance of net durability and the average useful life of a net is increasingly recognized as one of the critical factors that determine how often nets need to be replaced. A study to assess the effect of a net care and repair behaviour change communication (BCC) programme on net durability was conducted in one district in Eastern Uganda with a district in a neighbouring region serving as a comparison. Both districts had received LLINs in September of 2012. METHODS: The intervention was comprised of radio programmes, school and community events. Two-stage cluster sampling household surveys to assess net condition, exposure to BCC messages, and attitudes towards net care and repair were conducted in both districts at baseline (2-3 months post net distribution) and endline (20-21 months post distribution). Net condition was assessed using the proportionate hole index, with nets being classified as either serviceable or too torn. RESULTS: The intervention led to an additional 31.2 % increased exposure to net care and repair messages in the intervention district. Respondents in the intervention district had a more positive attitude towards net care and repair (32 % of respondents were classified as having a very positive attitude compared to 10 % in the comparison district), which was positively associated with the number of channels through which messages had been received (P < 0.001). Nets belonging to respondents with a very positive attitude were more often categorized as serviceable (80.2 %) compared to respondents with a poor/average attitude (66.4 %; odds ratio: 2.05, P = 0.028); however, this was only observed for the net brand with the greater physical integrity. Additionally, socio-economic status was a significant predictor of net condition. Although nets in the intervention district had significantly more repairs done per net, the act of repairing alone did not improve net condition. CONCLUSIONS: In conclusion, the evaluation showed that the BCC programme resulted in improved knowledge and attitudes towards care and repair, which impacted positively on net condition. Repairs alone were not sufficient to improve net condition. Additional research on which care behaviours and attitudes are most associated with improved net condition would help BCC planners hone their campaigns.