Gilles Forte

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 countrys 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.

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

PURPOSE A great proportion of the worlds 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 Childrens 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.

Essential medicines for cancer: WHO recommendations and national priorities

Abstract 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.

Tough decisions on essential medicines in 2015

This year, the Expert Committee for the Selection and Use of Medicines will consider requests to include high-cost medicines for can -cer, hepatitis C, multidrug-resistant tu -berculosis and new oral anticoagulants on the model list. These applications challenge perceptions of essential medi -cines and raise questions about how to address issues of cost and affordability for countries when making decisions at the global level.Essential medicines are those that satisfy the priority health-care needs of the population.

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

BackgroundIn 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.MethodsAvailability 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).ResultsComparisons 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.ConclusionsAll 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. Pediatr Blood Cancer 2015;62:1689–1693.

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.

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

BackgroundBarriers 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.MethodsWe 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.ResultsCountries 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.ConclusionMeTA 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.

Can a multistakeholder initiative improve transparency and accountability in the pharmaceutical sector? Evidence from the Medicines Transparency Alliance

Abstract Background Access to affordable quality essential medicines is crucial if universal health coverage and the Sustainable Development Goals are to be achieved. Multistakeholder initiatives might help to overcome barriers to access such as weak pharmaceutical sector governance and lack of transparency and public accountability. The Medicines Transparency Alliance (MeTA) is a multistakeholder initiative implemented in the pharmaceutical sectors of seven countries (Ghana, Jordan, Kyrgyzstan, Peru, the Philippines, Uganda, and Zambia) between 2008 and 2015. In this study, we aimed to assess whether MeTA has had an effect on transparency (defined here as the degree to which access to information is available and citizens are informed about how and why government decisions are made) and accountability in the pharmaceutical sector in the seven pilot countries. Methods We applied case study methods to examine MeTAs efforts to increase transparency and accountability in the seven pilot countries. We reviewed archival data that focused on MeTA Phase II (August, 2011, to December, 2015), although we also noted key events and data from Phase I. We included: country-level semi-annual progress reports, work plans, Department for International Development (DFID) annual review reports, MeTA global meeting notes and presentations, country-level technical study reports, stakeholder forum reports, country policies, and content from web sites and social media. We compared information between countries to identify commonalities and differences in strategies and tactics used to promote MeTAs goals and, where possible, identify how these strategies might link to project results, particularly with regard to improving access to medicines. Findings We found that the pilot countries used special studies and analyses, open meetings, and proactive information dissemination strategies to expand transparency. Additionally, MeTA fostered multistakeholder policy dialogue to bring together different actors to discuss evidence on access to medicines barriers and progress. We found strong evidence that transparency was improved, for example, through the promotion of proactive dissemination strategies by the government, as well as open public meetings to discuss medicines access issues. Furthermore, MeTAs efforts contributed to new policies, such as revised national medicines policies (for example, in Ghana, Kyrgyzstan, and Uganda) and the elimination of taxes on imported raw material for medicines, as happened in Ghana. Interpretation Our study provides evidence that transparency can be improved in the pharmaceutical sector through multistakeholder initiatives, and that increased availability of information, coupled with communications between the various stakeholders, could facilitate progress towards access-to-medicines goals and result in greater government accountability. Longer-term outcomes will depend on the sustainability of initiatives, which is furthered predominantly through country ownership of such programmes, and specific actions to promote transparency in the pharmaceutical sector as good practice and clarify how information is used to hold institutions and leaders accountable for performance. Funding World Health Organization through a grant from the UK Department for International Development.