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1a. Access: Global Strategies to Improve Access to Medicines in LMIC
Progress in Standard Indicators of Medicines Use Over 20 Years
1World Health Organization, Regional Office S.E.Asia, India; 2World Health Organization, Geneva; 3Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, USA
Problem statement: Irrational use of medicines is a global problem, especially in low- and middle-income countries (LMIC) where there is no routine surveillance of medicines use and scant evidence about effective interventions
Objectives: To undertake a systematic review of studies from 1990 to 2009 on patterns of medicines use and intervention effects in LMIC
Design and methods: From published and unpublished studies, we systematically extracted data on commonly used indicators of medicine use, plus study setting, methodology, and interventions. To estimate trends over time, we calculated the average of each indicator (limited to baseline data for interventions) by study year, region, facility ownership, and prescriber type. To estimate intervention impacts, we calculated summary effect sizes for studies meeting accepted design criteria (RCT, pre-post with control, time series). We examined the indicator showing the greatest effects size (GES) and the median effect size (MES) over all indicators.
Setting: Primary care settings in LMIC
Study population: Providers and patients
Intervention(s): Different types of interventions commonly implemented to improve use of medicines
Outcome measure(s): Standard indicators of medicine use developed by the International Network for the Rational Use of Drugs (INRUD) and WHO
Results: Data were extracted for studies conducted in 104 countries that reported data on 1,033 study groups; 70% reported data from the public sector and 30% from the private (mostly) for-profit sector. In all, 405 studies (39%) reported on interventions, but only 110 (27%) used an adequate study design. From 1992 to 2009, the percentage of patients treated in compliance with guidelines was 40–50% in the public sector, but <30% in the private-for-profit sector. Other indicators also showed suboptimal use: average number of medicines per patient increased from 2.1 to 2.8 and the percentage of patients receiving antibiotics from 45 to 54%; however, the percentage of medicines prescribed from an essential medicines list increased from 70 to 87%. Results were similar in all regions. Multi-component interventions tended to have larger effects than single-component ones. The median GES was 38% for multi-component interventions that combined provider and consumer education with supervision, but only 16% for those relying on provider education alone and 4% for printed materials alone. The median MES across all indicators was lower (27%, 7%, and 1%, respectively) for these three types of interventions.
Conclusions: The WHO database can be used to monitor global progress on medicines use. Trends over the past 20 years indicate that irrational use remains a serious global problem. Although some interventions demonstrate positive effects, there are few observable improvements in practice.
Funding source(s): WHO
Designing Methodology for Multi-stakeholder Rankings Aimed at Improving Access to Medicine—The Case of the Access to Medicine Index for the Pharmaceutical Industry
MSCI—Access to Medicine Foundation, France
Problem statement: There has been a long standing debate about the role of pharmaceutical industry and what is considered to be its best practices regarding the access to medicine issue in the low- and medium-income countries. I led methodology design and analysis for the second iteration of Access to Medicine Index for the pharmaceutical industry which was successfully launched in June 2010. I would like to present the process and the challenges involved in designing methodology for the Access to Medicine Index.
Objectives: The index attempts to establish best practices for companies’ behavior based on a multi-stakeholder engagement process and to rank company policies and practices based on the established criteria. The index aims (1) to function as a learning tool for the industry through establishing and describing best company practices; (2) through the ranking process, to motivate competition among the pharmaceutical companies on this topic on the four dimensions of commitments, transparency, performance, and business model innovation with impact on access to medicine; (3) to serve as a decision support tool for other stakeholders who interact and collaborate with the pharmaceutical industry, through establishing the expectations from the industry and ranking the companies; and (4) to facilitate dialog among the stakeholders on access to medicine.
Design: The methodology of Access to Medicine Index (2010) includes the technical areas of (1) access to medicine management, (2) public policy and market influence, (3) research and development, (4) pricing, (5) manufacturing and distribution, (6) patents and licensing, (7) capacity advancement, and (8) donations and philanthropy. To measure the above, the 2010 index included 107 indicators across the mentioned technical areas.
Study population: The Access to Medicine Index (2010) covered the 20 largest originator pharmaceutical companies and also the 7 largest generics manufacturers.
Policy change: The index has had visible impact on the volume and quality of disclosure of several pharmaceutical companies regarding access to medicine. The access to medicine foundation undertakes ongoing efforts to both facilitate and measure the impact of the index on changes in companies practices and programs related to access to medicine.
Conclusions: Following presentation of the methodology of the 2010 index, I would like to discuss the key challenges in designing methodologies for measuring policy and performance based on a multi-stakeholder engagement process such as the following:
(1) Variability in business models and how to reflect it in business models design—for example, for insulin manufacturers. (2) High correlation between transparency and performance indicators. (3) How to score performance for the companies for which data are not available. (4) How to address data provided by the companies in different formats and structures, including differences in geographical breakdown of revenue and differences in measurement approach to supply volume. (5) How to approach the issue of malpractices.
Funding source(s): Information not provided
Priority Policy Research Questions in the Area of Access to Medicines in Latin America, Middle East, and Asia
1World Health Organization, Switzerland; 2National Institute of Public, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; 3National Institute of Health Research, Tehran University of Medical Sciences, Iran; 4Public Health Foundation of India; 5Centre for Advanced Studies, Phnom Penh, Cambodia
Problem Statement: Access to Medicines (ATM) is weak in low- and middle-income countries (LMICs). WHO estimates that the average availability of essential drugs in LMICs is 35% in public sector facilities and 66% in the private sector. Medicines account for a high proportion of health spending in LMICs, where 50–90% of expenditure on medicines is out-of-pocket. This inequitable mode of financing creates significant access barriers for the poor and leads to catastrophic household expenditures. Despite some progress in areas such as price and availability, data on ATM is weak. Even where data are available, there is limited contextual evidence and weak capacity for translation of evidence to policy. There is therefore an urgent need to identify relevant policy research questions related to ATM, and support generation and synthesis of evidence to inform medicines policies.
Objectives: The current work is being done to (1) identify and rank policy concerns related to ATM as perceived by policy makers, civil society organizations, communities, and patients in several countries in Latin America, Asia, and the Middle East; (2) identify and rank related policy research questions in the field of ATM.
Design: Published and grey literature search and analysis complemented by key informant interviews at country and regional level
Setting: Latin America, Asia, and the Middle East
Interventions: The following steps have been followed in the priority setting process—(1) definition of context and scope of ATM for the current exercise; (2) definition of a bottom-up country-driven approach; (3) mapping of stakeholders; (4) information gathering through published and grey literature search complemented by key informant interviews; (5) definition of criteria for selecting priorities; and (6) selecting priority policy research questions in the field of ATM.
Outcome Measure: Policy concerns, issues, and barriers around access to medicines in the Latin American, Asian, and Eastern Mediterranean Regions will be presented according to the 4 dimensions of the World Health Organization Framework for Equitable Access to Essential Medicines—rational selection and use, affordability, sustainable financing, and reliable health systems. The exercise will further identify at which level of the health system barriers occur: individuals and communities, health services and facilities, health sectors and beyond the health sector. Health system research questions will be formulated to answer identified policy concerns. These questions will be prioritized according to predefined criteria.
Results and conclusions: Will be available at the time of the conference
Funding Source: UK Department for International Development
Increasing Access to Medicines—Taking a Multifaceted Approach
Department for International Development, United Kingdom
Problem Statement: Access to medicines in developing countries is determined by a complex mix of international and local factors, public and private sector interactions and economic, political and social drivers. Analytical frameworks are needed to support strategic and multidisciplinary approaches to policy development and implementation to improve access to medicines in developing countries.
Objectives: To outline the analytical framework used to prioritise investments in access to medicines policy and programming by the DFID. To also discuss progress and challenges in implementation.
Design: A descriptive study drawing on literature review, project documentation, and project evaluations across a range of UK/DFID interventions to support increased access to medicines in developing countries.
Setting: Examples of work at international, regional, and country levels that illustrate and explore how interventions overlap and support (or conflict) with each other to support increased access to medicines.
Study Population: People living in developing countries, with particular focus on the poor and countries where the UK supports bilateral programmes in the health sector.
Interventions: Interventions include: (1) influencing policy; (2) project funding to improve the quality and availability of information relating to medicines at international, company, and country levels; (3) investments in policy research; and (4) direct investments and engagement in activities to shape international commodity markets for pharmaceuticals.
Policy(ies): Development of and contributions to a number of UK strategies and policy positions including (1) access to medicines; (2) working with the international pharmaceutical industry; (3) UK government strategies on HIV; malaria; and reproductive, maternal, and newborn health; (4) DFID research strategy, including investments in new health product development; and (5) UK government positions on intellectual property, innovation, and public health.
Outcome Measure(s): These include (1) changes in international policy, (2) prices of medicines on iternational markets, (3) quality and availability of information on pharmaceutical markets, (4) availability and affordability of selected medicines in developing countries, and (5) size of research pipleline for new prevention, diagnostic, and treatment technologies.
Results: These include a reductions in the price of key HIV medicines, improved transparency in pharmaceutical sectors in MeTA countries, and increased investment in R&D for new health technologies for developing country use.
Conclusions: Access to medicines policy development and implementation requires a multifaceted approach that links interventions along the pharmaceutical value chain, and that locates this value chain within the contexts of broader health, political, economic, and social drivers.
Funding Source: The UK Department for International Development.
R&D Pharmaceutical Industry’s Partnerships to Improve Developing World Health
International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Switzerland
Problem statement: The UN Millennium Development Goals aim to mobilize the public and private sectors worldwide to address poverty and poor health in developing countries. Research-based pharmaceutical companies help address the health-related MDGs (4, 5, 6 and 8e) and other global health challenges via a significant and growing range of philanthropic or not-for-profit partnership programs to help improve health in developing countries. However, the scale and scope of these activities are not well known.
Objectives: To outline the evolving scale and scope of research-based pharmaceutical companies’ developing world health partnership programs
Design: The presentation will show how the industry’s engagement has grown and broadened, with more companies working with more expert partners, including intergovernmental organizations, national governments, and civil society. For example, the total number of industry programs documented by the IFPMA has grown from 36 in 2003 to 213 in 2010. The expansion of the range of health issues addressed by company programs, from infectious diseases such as HIV/AIDS, TB, and malaria to child and maternal health and chronic diseases, will be examined. The range of activities undertaken within such programs will be reviewed, showing how access to medicines is complemented by health care capacity-building, education, and R&D for developing world health needs. The sustainability of programs, some of which significantly predate the MDGs, will be reviewed, as will their geographic distribution. Program trends will be evaluated for evidence of lessons learned and new thinking. The presentation will principally involve analysis of information gathered by the IFPMA in its Developing World Health Partnerships Directory, its 2010 IFPMA Health Partnerships Survey, and its Status Report on R&D for Diseases of the Developing World, covering 10 main diseases.
Setting: All programs undertaken by industry to help improve health in low- or middle-income countries worldwide, as classified by the World Bank, are eligible for inclusion in the IFPMA Developing World Health Directory and for the IFPMA Health Partnerships Survey.
Study population: Industry programs cover all low- and middle-income countries
Intervention(s): The range of program activities documented in the cited IFPMA sources.
Policies: Policies vary considerably, but trends and outliers will be identified.
Outcome measures: Number of programs, number of treatments made available, value of cash and in-kind assistance provided, numbers of R&D projects, range of partner organizations, program duration, etc.
Results: Numbers of people treated, disease elimination progress, new medicines developed
Conclusions: The industry’s developing world health partnership effort has increased considerably in size and scope over the period 2000–2009.
Funding sources: IFPMA