Access to Controlled Medicines in Low-Income Countries: Listening to Stakeholders in the Field.

Little is known on current practices and challenges associated with the legal trade of medicines controlled under international conventions in low-income countries. This qualitative survey involved semi-structured interviews of stakeholders engaged in the trade of controlled medicines at a global level or at a country level in 3 African countries (Uganda, Kenya, Democratic Republic of the Congo). Nine interviews were conducted, including 3 international wholesalers, 2 relief organizations, 2 procurement officers, and 2 regulatory officers. Additionally, 4 other participants provided written information. All participants consistently reported that the current process of procuring controlled medicines in compliance with international conventions was long and complex given the number of administrative steps required for obtaining export and import authorizations, which are mandatory for both narcotic and psychotropic medicines. It may be difficult or impossible to obtain import authorizations from some health authorities in low-income countries because of long delays, mistakes in forms, absence or shortage of staff, or when annual national estimates are exceeded. The complexities of the trade of controlled medicines directly contribute to the lack of access to essential controlled medicines, both narcotics and psychotropics, in low-income countries.

Identifying the most effective essential medicines policies for quality use of medicines: A replicability study using three World Health Organisation data-sets.

BACKGROUND: Poor quality use of medicines (QUM) has adverse outcomes. Governments' implementation of essential medicines (EM) policies is often suboptimal and there is limited information on which policies are most effective. METHODS: We analysed data on policy implementation from World Health Organisation (WHO) surveys in 2007 and 2011, and QUM data from surveys during 2006-2012 in developing and transitional countries. We compared QUM scores in countries that did or did not implement specific policies and regressed QUM composite scores on the numbers of policies implemented. We compared the ranking of policies in this and two previous studies, one from the same WHO databases (2003-2007) the other from data obtained during country visits in South-East Asia (2010-2015). The rankings of a common set of 17 policies were correlated and we identified those that were consistently highly ranked. FINDINGS: Fifty-three countries had data on both QUM and policy implementation. Forty policies were associated with effect sizes ranging from +13% to -5%. There was positive correlation between the composite QUM indicator and the number of policies reported implemented: (r) = 0.437 (95% CI 0.188 to 0.632). Comparison of policy rankings between the present and previous studies showed positive correlation with the WHO 2003-7 study: Spearman's rank correlation coefficient 0.498 (95% CI 0.022 to 0.789). Across the three studies, five policies were in the top five ranked positions 11 out of a possible 15 times: drugs available free at the point of care; a government QUM unit; undergraduate training of prescribers in standard treatment guidelines, antibiotics not available without prescription and generic substitution in the public sector. INTERPRETATION: Certain EM policies are associated with better QUM and impact increases with co-implementation. Analysis across three datasets provides a policy short-list as a minimum investment by countries trying to improve QUM and reduce antimicrobial drug misuse.

Increasing transparency and accountability in national pharmaceutical systems.

Access to safe, effective, good-quality medicines can be compromised by poor pharmaceutical system governance. This system is particularly vulnerable to inefficiencies and to losses from corruption, because it involves a complex mix of actors with diverse responsibilities. A high level of transparency and accountability is critical for minimizing opportunities for fraud and leakage. In the past decade, the Good Governance for Medicines programme and the Medicines Transparency Alliance focused on improving accountability in the pharmaceutical system and on reducing its vulnerability to corruption by increasing transparency and encouraging participation by a range of stakeholders. Experience with these two programmes revealed that stakeholders interpreted transparency and accountability in a range of different ways. Moreover, programme implementation and progress assessments were complicated by a lack of clarity about what information should be disclosed by governments and about how greater transparency can strengthen accountability for access to medicines. This article provides a conceptual understanding of how transparency can facilitate accountability for better access to medicines. We identified three categories of information as prerequisites for accountability: (i) standards and commitments; (ii) decisions and results; and (iii) consequences and responsive actions. Examples are provided for each. Conceptual clarity and practical examples of the information needed to ensure accountability can help policy-makers identify the actions required to increase transparency and accountability in their pharmaceutical systems. We also discuss factors that can hinder or facilitate the use of information to hold to account those responsible for improving access to medicines.

L'accès à des médicaments sûrs, efficaces et de bonne qualité peut être compromis par la mauvaise gouvernance du secteur pharmaceutique. Celui-ci est particulièrement exposé aux inefficacités et aux pertes dues à la corruption, du fait qu'il implique un ensemble complexe d'acteurs aux différentes responsabilités. Une grande transparence et l'obligation de rendre des comptes sont indispensables pour minimiser les possibilités de fraude et de fuite. Durant la dernière décennie, le programme de Bonne gouvernance dans le secteur pharmaceutique et l'initiative Medicines Transparency Alliance se sont attachés à améliorer la reddition de comptes dans le secteur pharmaceutique et à réduire la vulnérabilité de ce dernier face à la corruption, en augmentant la transparence et en encourageant la participation de nombreuses parties prenantes. L'expérience de ces deux programmes a révélé que les parties prenantes interprétaient la transparence et la reddition de comptes de différentes manières. En outre, la mise en œuvre des programmes et l'évaluation des progrès ont été compliquées par un manque de clarté quant aux informations que les gouvernements devaient communiquer et à la manière dont une plus grande transparence pouvait renforcer la reddition de comptes et l'accès aux médicaments. Cet article entend expliquer en quoi la transparence peut faciliter la reddition de comptes et améliorer l'accès aux médicaments. Nous avons identifié trois catégories d'informations nécessaires à la reddition de comptes: (i) normes et engagements; (ii) décisions et résultats; (iii) conséquences et mesures réactives. Des exemples sont présentés pour chaque catégorie. Un cadre théorique clair et des exemples pratiques d'informations nécessaires pour assurer la reddition de comptes peuvent aider les responsables politiques à déterminer les actions requises pour augmenter la transparence et la reddition de comptes dans leurs systèmes pharmaceutiques. Nous évoquons aussi les facteurs qui peuvent entraver ou faciliter l'utilisation des informations et engager la responsabilité des personnes chargées d'améliorer l'accès aux médicaments.

El acceso a medicamentos seguros, eficaces y de buena calidad puede verse comprometido por una mala gestión del sistema farmacéutico. Este sistema es particularmente vulnerable a las ineficiencias y a las pérdidas derivadas de la corrupción porque implica una compleja mezcla de distintos participantes con diversas responsabilidades. Un alto nivel de transparencia y responsabilidad es fundamental para minimizar las oportunidades de fraude y filtraciones. En la última década, el programa de Buena Gestión de los Medicamentos y la Alianza para la Transparencia de los Medicamentos se han centrado en mejorar la responsabilidad del sistema farmacéutico y en reducir su vulnerabilidad a la corrupción mediante el aumento de la transparencia y el fomento de la participación de una serie de partes interesadas. La experiencia con estos dos programas reveló que las partes interesadas interpretaban la transparencia y la responsabilidad de diversas maneras. Además, la implementación de los programas y las evaluaciones de progreso se complicaron debido a la falta de claridad sobre la información que deben divulgar los gobiernos y sobre cómo una mayor transparencia puede fortalecer la responsabilidad en el acceso a los medicamentos. Este artículo ofrece una explicación conceptual de cómo la transparencia puede facilitar la responsabilidad para un mejor acceso a los medicamentos. Se han identificado tres categorías de información como requisitos previos a la responsabilidad: (i) normas y compromisos; (ii) decisiones y resultados; y (iii) consecuencias y medidas de respuesta. Se ofrecen ejemplos de todas. La claridad de conceptos y los ejemplos prácticos de la información necesaria para garantizar la responsabilidad pueden ayudar a los responsables políticos a identificar las medidas necesarias para aumentar la transparencia y la responsabilidad en sus sistemas farmacéuticos. También se analizan los factores que dificultan o facilitan el uso de la información para responsabilizar a las personas responsables de mejorar el acceso a los medicamentos.

Guideline recommendations and antimicrobial resistance: the need for a change.

OBJECTIVES: Antimicrobial resistance has become a global burden for which inappropriate antimicrobial use is an important contributing factor. Any decisions on the selection of antibiotics use should consider their effects on antimicrobial resistance. The objective of this study was to assess the extent to which antibiotic prescribing guidelines have considered resistance patterns when making recommendations for five highly prevalent infectious syndromes. DESIGN: We used Medline searches complemented with extensive use of Web engine to identify guidelines on empirical treatment of community-acquired pneumonia, urinary tract infections, acute otitis media, rhinosinusitis and pharyngitis. We collected data on microbiology and resistance patterns and identified discrete pattern categories. We assessed the extent to which recommendations considered resistance, in addition to efficacy and safety, when recommending antibiotics. RESULTS: We identified 135 guidelines, which reported a total of 251 recommendations. Most (103/135, 79%) were from developed countries. Community-acquired pneumonia was the syndrome mostly represented (51, 39%). In only 16 (6.4%) recommendations, selection of empirical antibiotic was discussed in relation to resistance and specific microbiological data. In a further 69 (27.5%) recommendations, references were made in relation to resistance, but the attempt was inconsistent. Across syndromes, 12 patterns of resistance with implications on recommendations were observed. 50% to 75% of recommendations did not attempt to set recommendation in the context of these patterns. CONCLUSION: There is consistent evidence that guidelines on empirical antibiotic use did not routinely consider resistance in their recommendations. Decision-makers should analyse and report the extent of local resistance patterns to allow better decision-making.

Promoting transparency, accountability, and access through a multi-stakeholder initiative: lessons from the medicines transparency alliance.

BACKGROUND: Barriers to expanding access to medicines include weak pharmaceutical sector governance, lack of transparency and accountability, inadequate attention to social services on the political agenda, and financing challenges. Multi-stakeholder initiatives such as the Medicines Transparency Alliance (MeTA) may help overcome these barriers. Between 2008 and 2015, MeTA engaged stakeholders in the pharmaceutical sectors of seven countries (Ghana, Jordan, Kyrgyzstan, Peru, Philippines, Uganda, and Zambia) to promote access goals through greater transparency. METHODS: We reviewed archival data to document MeTA activities and results related to transparency and accountability in the seven countries where it was implemented. We identified common themes and content areas, noting specific activities used to make information transparent and accessible, how data were used to inform discussions, and the purpose and timing of meetings and advocacy activities to help set priorities and influence governance decisions. The cross-case analysis looked for pathways which might link the MeTA strategies to results such as better policies or program improvements. RESULTS: Countries used evidence gathering, open meetings, and proactive information dissemination to increase transparency. MeTA fostered policy dialogue to bring together the many government, civil society and private company stakeholders concerned with access issues, and provided them with information to understand barriers to access at policy, organizational, and community levels. We found strong evidence that transparency was enhanced. Some evidence suggests that MeTA efforts contributed to new policies and civil society capacity strengthening although the impact on government accountability is not clear. CONCLUSION: MeTA appears to have achieved its goal of creating a multi-stakeholder shared policy space in which government, civil society, and private sector players can come together and have a voice in the national pharmaceutical policy making process. Assuming that transparency is in place to leverage accountability, the success of MeTA's efforts to promote accountability by the government as well as other stakeholders in the pharmaceutical sector will depend on how well efforts are sustained over time.

Essential medicines for cancer: WHO recommendations and national priorities.

OBJECTIVE: To examine, for essential anti-cancer medicines, the alignment of national lists of essential medicines and national reimbursable medicines lists with the World Health Organization's (WHO's) Model Lists. METHODS: National medicine lists for 135 countries with per-capita gross national incomes below 25 000 United States dollars in 2015 were compared with WHO's 2013 and 2015 Model Lists of Essential Medicines. Correlations between numbers of anti-cancer medicines included in national lists and gross national income (GNI), government health expenditure and number of physicians per 1000 population were evaluated. FINDINGS: Of the 25 anti-cancer medicines on the 2013 Model List and the 16 added via the 2015 revision of the Model List, 0-25 (median: 17) and 0-15 (median: 3) appeared in national lists, respectively. There was considerable variability in these numbers within and between World Bank income groups. Of the 16 new medicines included in the 2015 Model List, for example, 0-10 (median: 1) and 2-15 (median: 10) were included in the national lists of low-income and high-income countries, respectively. The numbers of these new medicines included in national lists were significantly correlated (P ≤ 0.0001) with per-capita GNI (r = 0.45), per-capita annual government health expenditure (r = 0.33) and number of physicians per 1000 population (r = 0.48). Twenty-one countries (16%) included the targeted anti-cancer medicines imatinib, rituximab and trastuzumab in their national lists. CONCLUSION: Substantial numbers of anti-cancer medicines are included in national lists of low- and middle-income countries but the availability, affordability, accessibility and administration feasibility of these medicines, at country-level, need assessment.

Medicine shortages: a commentary on causes and mitigation strategies.

Shortages of medicines and vaccines have been reported in countries of all income levels in recent years. Shortages can result from one or multiple causes, including shortages of raw materials, manufacturing capacity problems, industry consolidation, marketing practices, and procurement and supply chain management. Existing approaches to mitigate shortages include advance notice systems managed through medicine regulatory authorities, special programmes that track medicines, and interventions to improve efficiency of the medicine supply chain. Redistribution of supplies at the national level can mitigate some shortages in the short term. International redistribution and exceptional regulatory approvals may be used in limited circumstances, with the understanding that such approaches are complex and may introduce cost and quality risks. If it is necessary to prioritise patients to receive a medicine that is in shortage, evidence-based practice should be used to ensure optimal allocation. Important steps in reducing medicine shortages and their impact include identifying medicines that are most at risk, developing reporting systems to share information on current and emerging shortages, and improving data from medicine supply chains.

Proposing Essential Medicines to Treat Cancer: Methodologies, Processes, and Outcomes.

PURPOSE: A great proportion of the world's cancer burden resides in low- and middle-income countries where cancer care infrastructure is often weak or absent. Although treatment of cancer is multidisciplinary, involving surgery, radiation, systemic therapies, pathology, radiology, and other specialties, selection of medicines that have impact and are affordable has been particularly challenging in resource-constrained settings. In 2014, at the invitation of the WHO, the Union for International Cancer Control convened experts to develop an approach to propose essential cancer medicines to be included in the WHO Model Essential Medicines Lists (EML) for Adults and for Children, as well as a resulting new list of cancer medicines. METHODS: Experts identified 29 cancer types with potential for maximal treatment impact, on the basis of incidence and benefit of systemic therapies. More than 90 oncology experts from all continents drafted and reviewed disease-based documents outlining epidemiology, diagnostic needs, treatment options, and benefits and toxicities. RESULTS: Briefing documents were created for each disease, along with associated standard treatment regimens, resulting in a list of 52 cancer medicines. A comprehensive application was submitted as a revision to the existing cancer medicines on the WHO Model Lists. In May 2015, the WHO announced the addition of 16 medicines to the Adult EML and nine medicines to the Children's EML. CONCLUSION: The list of medications proposed, and the ability to link each recommended medicine to specific diseases, should allow public officials to apply resources most effectively in developing and supporting nascent or growing cancer treatment programs.

Medicines availability for non-communicable diseases: the case for standardized monitoring.

BACKGROUND: In response to the global burden of non-communicable diseases (NCDs), the World Health Organization (WHO) has developed a Global Action Plan that includes a voluntary medicines target of 80% availability and affordability of essential medicines for the prevention and treatment of diabetes, cardiovascular disease and respiratory disease both in public and private health facilities. Reliable measures of medicines availability are needed to track progress towards meeting this target. The results of three studies measuring the availability of medicines for hypertension and diabetes conducted in Tanzania in 2012-2013 were compared to assess the consistency of the results across the studies. METHODS: Availability was defined by observation of the medicine (no minimum quantity) on the day of the survey. The three studies involved 24, 107 and 1297 health facilities. Estimates of the availability of medicines for hypertension and diabetes were compared for medicines availability overall, by managing authority (government, mission/faith-based, private-for-profit), by facility level (hospital, health centre, dispensary) and by setting (urban, rural). RESULTS: Comparisons of the availability of medicines were limited by differences in the definitions of the medicines and the classifications of the facilities surveyed. Metformin was variously reported as available in 33%, 39%, 46%, and 57% of facilities. Glibenclamide availability ranged from 19% to 52%. One study reported low levels of insulin availability (9-16% depending on insulin type) compared to 34% in a second study. Captopril (or angiotensin converting enzyme [ACE] inhibitor) availability ranged from 13% to 48%while availability of calcium channel blockers was 29% to 57% and beta-blockers 15% to 50%. Trends were similar across studies with lower availability in government compared to mission or private facilities, in dispensary and health centres compared to hospitals, and in rural compared to urban facilities. CONCLUSIONS: All three studies showed suboptimal availability of NCD medicines, however the estimates of availability differed. Regular monitoring using reproducible methods and measuring key medicines must replace ad-hoc studies, small selected samples and differences in definitions. Low and middle-income countries need to implement monitoring and evaluation systems to track progress towards meeting the NCD medicines target and to inform country-level interventions to improve access to NCD medicines.

Medicines for cancers in children: The WHO model for selection of essential medicines.

Pressures to include more cancer medicines in the WHO Model List of Essential Medicines (EML) pose challenges for the Expert Committee responsible for recommending changes to the list. How do medicines for cancer fit within a definition of essential medicines as those meeting the priority health needs of the population? Will identifying a medicine as "essential" offer some leverage to improve access to effective cancer medicines in low and middle-income countries (LMICs)? The addition of a number of medicines for the treatment of cancers in children to the Model List of Essential Medicines for Children (EMLc) in 2011 provides important insights into previous Expert Committee decision-making and offers a platform for future deliberations. As combination chemotherapy is required for effective treatment of many malignancies, a disease-based approach makes more sense than an agent-based approach. Inadequate financing to purchase essential medicines is a reality in many LMICs, thus a consideration of health impact is central to decisions on the selection and procurement of medicines. Inclusion in national EMLs should identify medicines that have priority for procurement in the public sector. This article will discuss some of the factors taken into account by the Expert Committee in developing the WHO EMLc. We argue that the disease-based approach coupled with the assessment of the magnitude of the clinical benefit provides an appropriate approach for considering further additions of medicines for pediatric cancers and for the review of the adult cancer section of the Model List.

What essential medicines for children are on the shelf?

OBJECTIVE: To document the inclusion of key medicines for children in national essential medicines lists (EMLs) and standard treatment guidelines, and to assess the availability and cost of these medicines in 14 countries in central Africa. METHODS: Surveys were conducted in 12 public and private sector medicine outlets in each country's capital city. Data were collected on medicine availability on the survey day and on the cost to the patient of the lowest priced medicine in stock. FINDINGS: The proportion of survey medicines in national EMLs ranged from 50% to 90%. In only three countries were more than 50% of such medicines available from central medical stores (range: 15-75%). Availability in nongovernmental organization stores was not consistently better (range: 10-65%) but tended to be higher in teaching hospitals, although the range was similar (15-70%). District hospitals (range: 10-80%) had slightly better availability than teaching hospitals, while primary health care clinics generally had poorer availability (range: 18-48%). Retail or private pharmacies tended to have more survey medicines available (range: 38-62%). There was considerable variability in prices, which tended to be higher in retail pharmacies. CONCLUSION: The availability of key essential medicines for children was poor. Better understanding of the supply systems in the countries studied and of the pattern of demand for medicines is needed before improvements can be made. Medicines must be available, affordable and acceptable to patients. Substantial progress towards Millennium Development Goals will not occur without a major effort to improve access to medicines for children.