Uptake of orphan drugs in the WHO essential medicines lists.

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

Equity and unmet need of non-communicable diseases services in Saudi Arabia using a National Household Survey (2019).

BACKGROUND: Saudi Arabia is implementing a comprehensive health system transformation in health services provision, governance, and financing. Given the high burden of non-communicable diseases (NCD), a key objective of the transformation is to integrate NCD prevention and treatment into primary care. The study objectives were to assess primary care service use for treatment of NCDs, to quantify existing inequities in preventive services utilization, and to identify regional and sociodemographic factors associated with these inequities. METHODS: Using the 2019 Kingdom of Saudi Arabia World Health Survey, multivariable logistic regression models were conducted to identify predictors of utilization of primary care services for NCD prevention and treatment, unmet need among those with a diagnosis of diabetes, hypertension, or dyslipidemia, and unmet need in breast and cervical cancer screening. RESULTS: Among those with an NCD diagnosis, living in a high-income household was associated with a lower probability of having an unmet need compared to those in low-income households. Furthermore, rural residents were less likely to have an unmet need compared to urban residents (OR 0.58, p=0.029). Individuals without a perceived need for healthcare within the last 12 months had three times the probability of unmet need in comparison to those with such a perceived need (p<0.001). Women in all regions had a lower probability of ever having a mammogram compared to women in the central regions around Riyadh. Women with an education above a secondary level had five times the odds of undergoing cervical cancer screening and three times the likelihood of ever having a mammogram (P=0.012, p=0.02) than other women. Compared to women in low-income households, those in middle (OR 1.99, P=0.026), upper middle (OR 3.47, p<0.001), or high-income households (OR 2.59, p<0.001) had a higher probability of having had cervical cancer screening. CONCLUSIONS: Inequities in NCD treatment and prevention services' utilization in Saudi Arabia are strongly associated with region of living, population density, wealth, income, education and perceived need for health care. More research is needed to better understand the extent of unmet primary care needs for NCD and how to address the underlying contributing factors to access inequities.

Feasibility and validity of using healthcare databases to conduct cross-national comparative studies of opioid use, its determinants and consequences.

PURPOSE: A cross-national comparative (CNC) study about opioid utilization would allow the identification of strategies to improve pain management and mitigate risk. However, little is known about the accessibility and validity of information in healthcare databases internationally. This study aimed to identify the feasibility of using healthcare databases to conduct a CNC study of opioid utilization and its associated consequences. METHODS: A cross-sectional survey was launched in March 2018, including experts interested in CNC studies comparing opioid utilization by purposeful sampling. An electronic survey was used to collect database characteristics, medicine information, and linkage information of each aggregate-level dataset (AD) and individual patient-level dataset (IPD). RESULTS: Overall, participants from 21 geographical regions reported 18 ADs and 19 IPDs. Information on dispensed medications is available from 17 ADs and 17 IPDs. Of the 16 ADs that include primary care settings, only 9 ADs can obtain information from secondary care settings. Fourteen IPDs included patients' characteristics or could be retrieved from linkage databases. Although most ADs are publicly accessible (n = 13), only five IPDs can be accessed without extra cost. CONCLUSION: Most ADs could be used to report opioid utilization in a primary care setting. IPDs with linkage databases should be applied to identify potential determinants, clinical outcomes, and policy impact. Data access restrictions and governance policies across jurisdictions can be challenging for timely analysis and require further collaboration.

Policy responses to COVID-19: lessons for the global trade and investment regime.

BACKGROUND: During the past two years, the COVID-19 pandemic has cost millions of lives around the globe, caused major morbidity and provoked widespread economic and social disruption. In response, governments have enacted policies to mitigate the impacts of the pandemic. This research focuses in on policies aimed at increasing access to essential health products and services by comparing them to the global rules governing trade, investment and intellectual property. We have assessed whether these rules have or could have constrained countries in responding to this and future crises. The study identifies the nature and scope of the trade-related health sector policies implemented by our sample group of countries, selected because of their systemic significance: the United States, Germany, France, China, South Africa and India. Each policy is placed into one of five broad categories covered by trade and investment rules so that we could assess their consistency with those rules. RESULTS: We found, among other things, that the types of trade-related health measures were quite diverse. The high-income countries in our study were the most active in the policy space and tended to rely on subsidies-based measures while the middle-income countries relied more heavily on export and import measures. Policies directly relevant to intellectual property protection were virtually non-existent. When evaluating the implemented policies against the global trade and investment rules, we found potential constraints under five different types of rules: those governing subsidies, import and export trade barriers, investment measures, government procurement and trade-related intellectual property. CONCLUSIONS: Given the tension between the global rules and the practices of policymaking during the pandemic, we conclude that the tension must be resolved in favor of governments making policy rather than relying on existing exceptions or pushing national governments to comply more exactly with the rules. Although the pandemic itself does not respect national borders, governance still generally occurs at the national level because national governments are often the only entities with both the legal authority and the practical ability to respond.

Misinformation messages shared via WhatsApp in Mexico during the COVID-19 pandemic: an exploratory study.

Little is known about the role of WhatsApp in spreading misinformation during the start of the COVID-19 pandemic in Mexico. The aim of this study is to analyze the message content, format, authorship, time trends and social media distribution channels of misinformation in WhatsApp messages in Mexico. From March 18 to June 30, 2020 the authors collected all WhatsApp messages received via their personal contacts and their social networks that contained information about COVID-19. Descriptive and inferential statistics were used to analyze the scientifically inaccurate messages and the relationship between variables, respectively. Google image and video searches were carried out to identify sharing on other social media. Out of a total of 106 messages, the most frequently mentioned COVID-19 related message topics were prevention (20.0%), conspiracy (18.5%), therapy (15.4%) and origin of the virus (10.3%), changing throughout the pandemic according to users' concerns. Half of all WhatsApp messages were either images or videos. WhatsApp images were also shared on Facebook (80%) and YouTube (~50%). Our findings indicate that the design of information and health promotion campaigns requires to be proactive in adapting to the changes in message content and format of misinformation shared through encrypted social media.

As an encrypted social media platform with hardly accessible content, little is known about the role of WhatsApp in spreading misinformation messages (either false or misleading information) during the COVID-19 pandemic in Mexico. In this study, researchers studied the content, format, time and channel of distribution of WhatsApp messages containing information about COVID-19 collected via their personal contacts and their social networks from March 18 to June 30, 2020. Half of all messages were visually-appealing and the content changed according to the population´s concerns. WhatsApp messages were also distributed in several other social media platforms. Understanding the format and content of misinformation may help to design dynamic health information and promotion campaigns against it. Regulations of public social media such as Youtube can have a positive impact on WhatsApp.

Willingness to pay brand premiums for generic medicines in Kenya: A bidding game experiment.

BACKGROUND: Recent growth in the market share of higher priced branded generic medicines in low- and middle-income countries (LMICs) has raised concerns around affordability and access. We examined consumer willingness to pay (WTP) for branded versus unbranded generic non-communicable disease (NCD) medicines in Kenya. METHODS: We randomly assigned NCD patients to receive a hypothetical offer for either a Novartis Access-branded medicine or for an unbranded generic equivalent. We then analysed WTP data captured using a bidding game methodology. RESULTS: We found that WTP for Novartis Access medicines was on average 23% higher than for unbranded generic equivalents (p = 0.009). The WTP brand premium was driven almost entirely by wealthier patients. CONCLUSIONS: Our findings suggest that the dominance of branded generics in LMICs like Kenya reflect in part consumer preferences for these medicines. Governments and other health sector actors may be justified in intervening to improve access to these medicines and equivalent non-branded generics, particularly for the poorest patients who appear to have no preference for branded medicines.

Missing data on accessibility of children's medicines.

Child-appropriate medicines are essential for the safe and effective treatment of children, yet we have observed a large gap in the data required to adequately monitor access to these medicines. We have examined data on the availability and pricing of child-appropriate medicines across 50 surveys. Child-appropriate medicines for nine out of 12 priority diseases in children were infrequently surveyed or not at all. A similar data deficit on age-appropriate medicines is detectable in the broader scientific literature. We also note that existing instruments for collecting data on the availability or prices of medicines are limited in their ability to generate the required data for children. We have identified four priorities as key for improved monitoring of access to medicines for children: (i) dedicated child medicine surveys are needed on availability and prices of child-appropriate medicines; (ii) standardized survey instruments should include age-appropriate medicines and dosages; (iii) health facility service readiness survey tools should include the collection of data on the price of child-appropriate medicines in addition to the availability of medicines; and (iv) sustainable development goal indicator 3.b.3 should be modified to enable the monitoring of access to medicines for children. These deficiencies need to be addressed to ensure the monitoring of access to child medicines as part of the sustainable development goal agenda for 2030 and to implement appropriate interventions for improving access for this vulnerable population.

Disposer de médicaments adaptés aux enfants est essentiel à l'administration d'un traitement sûr et efficace. Pourtant, nous avons observé de vastes lacunes dans les données requises pour évaluer l'accès à ces médicaments. Nous avons passé 50 enquêtes au crible, à la recherche d'informations sur la disponibilité et le prix des médicaments pédiatriques. Dans le cas de neuf maladies infantiles prioritaires sur douze, les médicaments adaptés aux enfants n'étaient pas ou peu étudiés. Même constat dans le contexte plus large de la littérature scientifique. Nous avons également remarqué que les instruments servant à récolter des données sur la disponibilité ou le prix des médicaments avaient leurs limites et ne permettaient pas d'obtenir les informations requises concernant les enfants. Nous avons identifié quatre priorités majeures en vue d'améliorer la surveillance de l'accès aux médicaments pédiatriques: (i) la réalisation d'enquêtes sur les médicaments pédiatriques afin d'en connaître la disponibilité et le prix; (ii) l'intégration des médicaments et dosages adéquats dans les instruments d'enquête standard; (iii) outre la disponibilité, la prise en compte du prix des médicaments à usage pédiatrique dans les outils d'évaluation de l'état de préparation des services au sein des établissements de santé; et enfin, (iv) la modification de l'indicateur 3.b.3 des objectifs de développement durable, qui prévoirait dès lors un contrôle de l'accès aux médicaments adaptés aux enfants. Ces lacunes doivent être comblées pour assurer un suivi en matière d'accès aux médicaments pédiatriques dans le cadre du Programme de développement durable à l'horizon 2030, mais aussi pour adopter les mesures correspondantes afin d'améliorer la prise en charge de cette population vulnérable.

Los medicamentos indicados para los niños son esenciales para su tratamiento seguro y eficaz, pero se ha observado un gran vacío en los datos necesarios para supervisar de manera adecuada el acceso a estos medicamentos. Se han analizado los datos sobre la disponibilidad y el precio de los medicamentos indicados para los niños en 50 encuestas. Estos medicamentos para nueve de las 12 enfermedades prioritarias infantiles se encuestaron con poca frecuencia o no se encuestaron en absoluto. En la literatura científica más general, se detecta un déficit de datos similar sobre los medicamentos adecuados para la edad. También se observa que los instrumentos existentes para recopilar los datos sobre la disponibilidad o los precios de los medicamentos son limitados en su capacidad para generar los datos necesarios en el caso de los niños. Se han identificado cuatro prioridades para mejorar el seguimiento del acceso a los medicamentos pediátricos: (i) se necesitan encuestas específicas sobre la disponibilidad y los precios de los medicamentos indicados para los niños; (ii) los instrumentos de encuesta estandarizados deben incluir medicamentos y dosis adecuados para la edad; (iii) las herramientas de encuesta sobre la disponibilidad de los servicios sanitarios deben incluir la recopilación de los datos sobre el precio de los medicamentos indicados para los niños, además de la disponibilidad de los medicamentos; y (iv) el indicador 3.b.3 del Objetivo de Desarrollo Sostenible se debe modificar para permitir el seguimiento del acceso a los medicamentos pediátricos. Es preciso solucionar estas deficiencias para garantizar el seguimiento del acceso a los medicamentos pediátricos como parte de la agenda de los objetivos de desarrollo sostenible para 2030 y aplicar las intervenciones adecuadas para mejorar el acceso de esta población vulnerable.

Probability and amount of medicines expenditure according to health insurance status in Kenya: A household survey in eight counties.

BACKGROUND: National and county governments in Kenya have introduced various health insurance schemes to protect households against financial hardship as a result of large health expenditure. This study examines the relationship between health insurance and medicine expenditure in eight counties in Kenya. METHODS: A cross-sectional study of collected primary data via household survey in eight counties was performed. Three measures of medicine expenditure were analysed: the probability of any out-of-pocket expenditure (OOPE) on medicines in the last 4 weeks; amount of OOPE on medicines; and OOPE on medicines as a proportion of total OOPE on health. RESULTS: Out of the 452 individuals, those with health insurance (n = 225) were significantly different from individuals without health insurance (n = 227): overall, they were older, had a higher level of educational attainment and possessed more assets. Adjusting for covariates, individuals with health insurance had a reduced probability of OOPE on medicines (0.40, CI95% 0.197-0.827) and spent proportionally less on medicines out of total health expenditure (0.50, CI95% 0.301-0.926). CONCLUSIONS: Kenya has made great strides to scale up Universal Health Coverage including access to medicines. Prioritising enrollment of low-income individuals with non-communicable diseases can accelerate access to medicines and financial protection.

Outpatient cardiovascular diseases and diabetes medicines dispensing in the population with government health insurance in Syria between 2018 and 2019: a retrospective analysis.

BACKGROUND: Low- and middle-income countries bear the highest burden of non-communicable diseases (NCDs) mortality and morbidity. Syria has undergone an epidemiological transition from infectious diseases to NCDs in the past decades. Despite the high prevalence of cardiovascular diseases (CVDs) and diabetes in Syria, little is known about medicines utilization or prescriptions for these diseases. The aims of this study are to present the patterns and rates of dispensing medicines used for CVDs and diabetes among patients with government health insurance in Syria and examine age, sex, and regional variation in the dispensing of these medicines. METHODS: Outpatient data from June 2018 to May 2019 on dispensed medicines for 81,314 adults with government health insurance were obtained. The dispensing rate was expressed as the number of defined daily doses (DDDs) per 1000 beneficiaries per day (DID). The DID is a measurement that is used in drug utilization research to control for differences or changes in population size between or within countries. The number of DIDs was adjusted according to beneficiaries' sex, age, and governorate. RESULTS: Beneficiaries received 302.09 DIDs of CVDs medicines and 35.66 DIDs of diabetes medicines, including 0.96 DID of insulin (2.99% of the total of diabetes medicines). CVDs and diabetes medicine dispensing rates were low during the study period and included very low rates of insulin dispensing compared to the dispensing rates of these medicines in other countries in East Mediterranean Region or in Europe. We found lower dispensing rates of CVDs medicines among female beneficiaries (249.59 DIDs) than male beneficiaries (388.80 DIDs). Similarly, the dispensing rates of diabetes medicines among female beneficiaries (29.42 DIDs) were lower than those among male beneficiaries (45.98 DIDs). In addition, there were lower rates of CVDs and diabetes medicines and very low to no dispensing of insulin in some governorates that were partly controlled by the Syrian government compared to other governorates that were completely or mostly controlled by the Syrian government. CONCLUSIONS: Additional efforts are needed to raise awareness about the prevention and management of CVDs and diabetes especially among females in Syria and consider cultural issues that might influence access to healthcare services. There is a crucial need to address the political and geographical challenges caused by the conflict which have limited access to CVDs and diabetes medicines in some regions in Syria.

Coping with access barriers to non-communicable disease medicines: qualitative patient interviews in eight counties in Kenya.

BACKGROUND: There is rich literature on barriers to medicines access for the treatment of non-communicable diseases (NCDs) in high-income countries. Less is known about low- and middle-income countries, in particular the differences in coping with medicines access barrier by household wealth and disease. The aim of this study was to compare the coping mechanisms of patients with the lack of availability and affordability of cardio-vascular diseases, diabetes and asthma medicines in Kenya. METHODS: This qualitative study was part of a larger mixed methods evaluation study conducted in eight counties of Kenya from 2016 to 2019. Forty-nine patient interviews at study end line explored their NCD journey, perceptions of availability, stockouts and affordability of NCD medicines, their enrollment in health insurance, and their relationship with the private chemists. Transcribed interviews were coded using Nvivo software. A two-step thematic approach was used, first conducting a priority coding which was followed by coding emerging and divergent themes. RESULTS: Overall, we found that patients across all disease types and wealth level faced frequent medicine stock-outs at health facilities. In the absence of NCD medicines at health facilities, patients coped by purchasing medicines from local chemists, switching health facilities, requesting a different prescription, admitting oneself to an inpatient facility, establishing connections with local staff to receive notifications of medicine stock, stocking up on medicines, utilizing social capital to retrieve medicines from larger cities and obtaining funds from a network of friends and family. Categorizing by disease revealed patterns in coping choices that were based on the course of the disease, severity of the symptoms and the direct and indirect costs incurred as a result of stockouts of NCD medicines. Categorizing by wealth highlight differences in households' capacity to cope with the unavailability and unaffordability of NCD medicines. CONCLUSIONS: The type of coping strategies to access barriers differ by NCD and wealth group. Although Kenya has made important strides to address NCD medicines access challenges, prioritizing enrollment of low wealth households in county health insurance programs and ensuring continuous availability of essential NCD medicines at public health facilities close to the patient homes could improve access.

Impacts of intellectual property provisions in trade treaties on access to medicine in low and middle income countries: a systematic review.

BACKGROUND: We present a systematic review describing ex-ante and ex-post evaluations of the impacts of intellectual property provisions in trade treaties on access to medicine in low and middle income countries. These evaluations focused on multilateral and bilateral trade agreements. We ascertained which IP provisions impacting access to medicines were the focus of these evaluations. We provide a further research agenda related to investigating the effect of trade agreement's intellectual property provisions on access to medicines. We followed systematic review guidelines with 7 different databases to identify post-2000 ex ante and ex post evaluations of trade treaties on access to medicines in low and middle-income countries. We included only quantitative ex-ante studies that used structural modeling and simulations to derive quantitative predictions and ex-post studies that utilized empirical data and econometric techniques to quantify the effects of intellectual property provisions in free trade agreements on host country's pharmaceutical industry. The search strategy identified 744 titles after removal of duplicates. We identified 14 studies that fulfilled all eligibility; 7 studies are ex-ante and 7 are ex-post. The studies looked at medicine price and cost, affordability, welfare effects and speed of medicine market launch. Changes in intellectual property policy due to the implementation of trade agreements affect price, medicines expenditure and sales, consumer welfare, and ultimately the affordability, of medicines. The direction and magnitude of the price effects differ between ex-ante and ex-post studies. Further, the reported impacts of policy changes due to trade agreements on medicine access seem clearly multifactorial. CONCLUSION: Both ex ante and ex post methods have advantages and limitations and, on balance, both types report, for the most part, an increase in price and a decrease in consumer welfare with imposition of intellectual property protection in trade agreements. The main differences between these studies are in the magnitude of the changes. There is a gap in our empirical understanding of the mechanisms through which such changes affect access to medicines and which outcomes relevant to access are most affected by which type of changes in intellectual property policy and law.

Access to medicines for asthma, diabetes and hypertension in eight counties of Kenya.

OBJECTIVE: To assess access to noncommunicable diseases (NCD) medicines in Kenya for patients diagnosed and prescribed treatment for asthma, diabetes and hypertension. METHODS: Households in eight purposively chosen counties were randomly selected. To be eligible, a household needed to have at least one member aged 18 years or older who had been previously diagnosed and prescribed medicines for one of the following NCDs: asthma, diabetes or hypertension. Using a logistic regression model, we explored the relationship between patient characteristics and the probability that patients had the medicines available at the time of the survey visit. RESULTS: A total of 627 individuals were included in the analysis. The highest percentage of medicines availability was in households with diabetes patients (83.1%), followed by hypertension (77.1%) patients. The lowest availability of medicines was found in households with asthma patients (53.1%). The median household expenditure on medicines per month was US$7.00 for households with diabetes patients; it was US$4.00 for asthma. In general, strong predictors of having medicines at home was being older, having some education compared to no education, few household members, wealth, being diagnosed at private nonprofit facilities and having only one patient with NCDs in the household. CONCLUSIONS: Our study found that nearly three-quarters of patients diagnosed and prescribed a medicine for hypertension, asthma or diabetes had the medicine available at home. Access challenges remain, in particular for patients from low-income households and for those diagnosed with asthma.

Monetary and nonmonetary household consumption of health services and the role of insurance benefits: An analysis of the Mexico's National Household Income and Expenditure Survey.

OBJECTIVES: To study the monetary and nonmonetary consumption of healthcare services at household level in Mexico and the magnitude of the contribution of public programs. METHODS: By using the National Household Income and Expenditure Survey 2012, we performed a cross-sectional and observational analysis of actual household consumption of health services by insurance type (no insurance, social security, Seguro Popular (SP)). Household consumption was divided into 2 categories: consumption related to "monetary" expenditure in health care and "nonmonetary" consumption in health care by the household. Nonmonetary included self-consumption or gifts received from other households and institutional contributions such as government payments or private organization transfers. RESULTS: In SP households, monetary and nonmonetary consumption of health services represented the highest proportion of available household expenditure (11.2%) compared to uninsured (8.4%) and social security (5.9%) households. The prevalence of outpatient consultation and medicine use is the highest among the health service consumption categories regardless of insurance status. Distribution of nonmonetary versus monetary consumption of health services was pro-poor: The poorer the households, the larger the proportion of nonmonetary consumption. CONCLUSIONS: The higher probability of receiving nonmonetary resources as a component of health service consumption in SP households is likely to increase the affordability to health services and likely to reduce healthcare expenditures. Future research should focus on the type of nonmonetary consumption of health services at household level to better understand financial protection and access to health care in Mexico.

Comparative analysis of essential medicines for cardiovascular diseases in countries of the WHO Eastern Mediterranean Region.

BACKGROUND: Adequate access to essential medicines for cardiovascular disease is necessary to address the high cardiovascular disease burden in countries of the Eastern Mediterranean Region of the World Health Organization (WHO). AIMS: This study compared the cardiovascular disease medicines included in the WHO Model Essential Medicines List with those in the national essential medicines lists of 19 countries of the Region. METHODS: Data were extracted on the number of cardiovascular medicines and dosage forms in the national lists and compared with those on the WHO Model List (24 medicines in total and 48 dosage forms). Factors associated with the number of essential cardiovascular medicines on the national lists (burden of cardiovascular diseases and health expenditure per capita) were assessed. The number of medicines from 6 therapeutic groups of cardiovascular medicines listed in the national lists but not in the core WHO Model List were evaluated. RESULTS: Countries with the lowest percentage of medicines from the WHO Model List out of the total cardiovascular disease medicines in the national lists were Djibouti (21%), Tunisia (22%), Saudi Arabia and Iraq (31% each), and Bahrain and Libya (32% each). The most common medicine dosage form in the national lists was tablets while some that needed oral liquid forms were not listed by any country. Tunisia (8%), Jordan (14%), Bahrain and Saudi Arabia (15% each) had the lowest alignment of dosage forms from the WHO model list. CONCLUSIONS: Countries should improve the selection of essential medicines for cardiovascular diseases to promote access to therapy.

Access to Medications for Cardiovascular Diseases in Low- and Middle-Income Countries.

Cardiovascular diseases (CVD) represent the highest burden of disease globally. Medicines are a critical intervention used to prevent and treat CVD. This review describes access to medication for CVD from a health system perspective and strategies that have been used to promote access, including providing medicines at lower cost, improving medication supply, ensuring medicine quality, promoting appropriate use, and managing intellectual property issues. Using key evidence in published and gray literature and systematic reviews, we summarize advances in access to cardiovascular medicines using the 5 health system dimensions of access: availability, affordability, accessibility, acceptability, and quality of medicines. There are multiple barriers to access of CVD medicines, particularly in low- and middle-income countries. Low availability of CVD medicines has been reported in public and private healthcare facilities. When patients lack insurance and pay out of pocket to purchase medicines, medicines can be unaffordable. Accessibility and acceptability are low for medicines used in secondary prevention; increasing use is positively related to country income. Fixed-dose combinations have shown a positive effect on adherence and intermediate outcome measures such as blood pressure and cholesterol. We have a new opportunity to improve access to CVD medicines by using strategies such as efficient procurement of low-cost, quality-assured generic medicines, development of fixed-dose combination medicines, and promotion of adherence through insurance schemes that waive copayment for long-term medications. Monitoring progress at all levels, institutional, regional, national, and international, is vital to identifying gaps in access and implementing adequate policies.

Health facility and skilled birth deliveries among poor women with Jamkesmas health insurance in Indonesia: a mixed-methods study.

BACKGROUND: The growing momentum for quality and affordable health care for all has given rise to the recent global universal health coverage (UHC) movement. As part of Indonesia's strategy to achieve the goal of UHC, large investments have been made to increase health access for the poor, resulting in the implementation of various health insurance schemes targeted towards the poor and near-poor, including the Jamkesmas program. In the backdrop of Indonesia's aspiration to reach UHC is the high rate of maternal mortality that disproportionally affects poor women. The objective of this study was to evaluate the association of health facility and skilled birth deliveries among poor women with and without Jamkesmas and explore perceived barriers to health insurance membership and maternal health service utilization. METHODS: We used a mixed-methods design. Utilizing data from the 2012 Indonesian Demographic and Health Survey (n = 45,607), secondary analysis using propensity score matching was performed on key outcomes of interest: health facility delivery (HFD) and skilled birth delivery (SBD). In-depth interviews (n = 51) were conducted in the provinces of Jakarta and Banten among poor women, midwives, and government representatives. Thematic framework analysis was performed on qualitative data to explore perceived barriers. RESULTS: In 2012, 63.0% of women did not have health insurance; 19.1% had Jamkesmas. Poor women with Jamkesmas were 19% (OR = 1.19 [1.03-1.37]) more likely to have HFD and 17% (OR = 1.17 [1.01-1.35]) more likely to have SBD compared to poor women without insurance. Qualitative interviews highlighted key issues, including: lack of proper documentation for health insurance registration; the preference of pregnant women to deliver in their parents' village; the use of traditional birth attendants; distance to health facilities; shortage of qualified health providers; overcrowded health facilities; and lack of health facility accreditation. CONCLUSIONS: Poor women with Jamkesmas membership had a modest increase in HFD and SBD. These findings are consistent with economic theory that health insurance coverage can reduce financial barriers to care and increase service uptake. However, factors such as socio-cultural beliefs, accessibility, and quality of care are important elements that need to be addressed as part of the national UHC agenda to improve maternal health services in Indonesia.

Seasonal variation in penicillin use in Mexico and Brazil: analysis of the impact of over-the-counter restrictions.

During 2010, Mexico and Brazil implemented policies to enforce existing laws of restricting over-the-counter sales of antibiotics. We determined if the enforcement led to more appropriate antibiotic use by measuring changes in seasonal variation of penicillin use. We used retail quarterly sales data in defined daily doses per 1,000 inhabitant-days (DDD/TID) from IMS Health from the private sector in Mexico and Brazil from the first quarter of 2007 to the first quarter of 2013. This database contains information on volume of antibiotics sold in retail pharmacies using information from wholesalers. We used interrupted time-series models controlling for external factors with the use of antihypertensives with interaction terms to assess changes in trend, level, and variation in use between quarters for total penicillin use and by active substance. The most used penicillin was amoxicillin, followed by amoxicillin-clavulanic acid and ampicillin (minimal use in Brazil). Before the restrictions, the seasonal variation in penicillin use was 1.1 DDD/TID in Mexico and 0.8 DDD/TID in Brazil. In Mexico, we estimated a significant decrease in the seasonal variation of 0.4 DDD/TID after the restriction, mainly due to changes in seasonal variation of amoxicillin and ampicillin. In Brazil, the seasonal variation did not change significantly, overall and in the breakdown by individual active substances. For Mexico, inappropriate penicillin use may have diminished after the restrictions were enforced. For Brazil, increasing use and no change in seasonal variation suggest that further efforts are needed to reduce inappropriate penicillin use.

Evaluating the quality and use of economic data in decisions about essential medicines.

OBJECTIVE: To evaluate the quality of economic data provided in applications to the World Health Organization (WHO) Model List of Essential Medicines and to evaluate the role of these data in decision-making by the expert committee that considers the applications. METHODS: We analysed applications submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines between 2002 and 2013. The completeness of data on the price and cost-effectiveness of medicines was extracted from application documents and coded using a four-point scale. We recorded whether or not the expert committee discussed economic information and the outcomes of each application. Associations between the completeness of economic data and application outcomes were assessed using χ2 tests. FINDINGS: The expert committee received 134 applications. Only eight applications (6%) included complete price data and economic evaluation data. Many applicants omitted or misinterpreted the economic evaluation section of the application form. Despite the lack of economic data, all applications were reviewed by the committee. There was no significant association between the completeness of economic information and application outcomes. The expert committee tried to address information gaps in applications by further review and analysis of data related to the application. CONCLUSION: The World Health Organization should revise the instructions to applicants on economic data requirements; develop new mechanisms to assist applicants in completing the application process; and define methods for the use of economic data in decision-making.

[Clinics adjacent to private pharmacies in Mexico: infrastructure and characteristics of the physicians and their remuneration]. / Consultorios adyacentes a farmacias privadas en México: infraestructura y características del personal médico y su remuneración.

OBJECTIVE: To analyze and compare the physicians' characteristics, their remuneration, the compliance with regulation and the services offered between clinics adjacent to pharmacies (CAF) and independent medical clinics (CMI). MATERIALS AND METHODS: Questionnaire applied to 239 physicians in 18 states including the Federal District, in Mexico in 2012. RESULTS: Physicians in CAF had less professional experience (5 versus 12 years), less postgraduate studies (61.2 versus 81.8%) and lower average monthly salaries (USD 418 versus USD 672) than their peers in CMI. In CAF there was less compliance in relation to medical record keeping and prescribing. CONCLUSIONS: The employment situation of physicians in CAF is more precarious than in CMI. It is necessary to strengthen the enforcement of existing regulations and develop policies according to the monitoring of its performance, particularly, but not exclusively, in CAF.

Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration.

Access to medicines and vaccines to prevent and treat non-communicable diseases (NCDs) is unacceptably low worldwide. In the 2011 UN political declaration on the prevention and control of NCDs, heads of government made several commitments related to access to essential medicines, technologies, and vaccines for such diseases. 30 years of experience with policies for essential medicines and 10 years of scaling up of HIV treatment have provided the knowledge needed to address barriers to long-term effective treatment and prevention of NCDs. More medicines can be acquired within existing budgets with efficient selection, procurement, and use of generic medicines. Furthermore, low-income and middle-income countries need to increase mobilisation of domestic resources to cater for the many patients with NCDs who do not have access to treatment. Existing initiatives for HIV treatment offer useful lessons that can enhance access to pharmaceutical management of NCDs and improve adherence to long-term treatment of chronic illness; policy makers should also address unacceptable inequities in access to controlled opioid analgesics. In addition to off-patent medicines, governments can promote access to new and future on-patent medicinal products through coherent and equitable health and trade policies, particularly those for intellectual property. Frequent conflicts of interest need to be identified and managed, and indicators and targets for access to NCD medicines should be used to monitor progress. Only with these approaches can a difference be made to the lives of hundreds of millions of current and future patients with NCDs.