Essential Medicines Programme Research Articles

The impact of the reference pricing policy in China on drug procurement and cost.

High drug costs are putting pressures on health care budgets and posing an obstacle for China to achieve universal coverage. Policies such as the direct price ceiling, and the Essential Medicines Program-with the Zero Markup Drug Policy (ZMDP) one key component-were implemented, coming out with limited evidence for a success. As a benchmark of China's recent health reform, Sanming city initiated the ZMDP in January 2013; and further piloted the first reference pricing (RP) policy in China in September 2014, with the intention to dis-incentivize the use of costly original drugs. In this study, we used hospital-based drug procurement data of 14 drug substances that were subjected to the RP, from four hospitals in Sanming and a neighbouring city Longyan, between 2012 and 2016. Adopting the difference-in-difference (DID) approach, we evaluated the impacts of the RP together with the ZMDP. On the one hand, we found that the ZMDP had no impact on drugs' procurement prices, volumes and costs. While on the other hand, we found that the introduction of RP was not associated with changes in unit prices for the 14 drugs in Sanming. However, the RP pilot was associated with a 25.9% [95% confidence interval (CI), 12.9-37.0%] decrease in monthly drug procurement volumes and a 47.7% (95% CI, 33.7-58.7%) decrease in the total drug costs. In particular, it reduced the procurement volumes of original drugs by 56.8% (95% CI, 47.0-64.7%). Subgroup analyses by hospital level and therapeutic class found similar results. We draw lessons for the Chinese government to experiment RP on a larger scale, considering the development and effective regulation of the generic market. This is a first report on the effects of RP in China, Asia and middle-income countries.

When more is less: What explains the overuse of health care services in China?

Overuse of health care services has become an increasingly severe problem in China. However, as both academic interests and practical efforts have mainly focused on reducing underuse, our understanding of overuse is far from complete. This study aims to analyze the status of overuse of health care services in China and explore both the supply- and demand-side factors associated with overuse. We took common cold, a self-limiting viral infection which requires no injections or infusions, as a tracer condition. Based on data from the fourth and fifth Health Service Survey of Shaanxi Province, we generated an observable indicator to measure overuse: whether or not a patient received infusion treatment for common cold during outpatient visits. The statistics showed that 58.73% and 37.56% of patients had infusion treatment for common cold during outpatient visits in 2008 and 2013, respectively. Based on this dependent variable, we employed Probit analysis to investigate factors influencing the overuse of health care services. The multivariate regression results showed that on the demand side, overuse was positively associated with low health literacy, long duration of illness, large family size, and high economic status. On the supply side, overuse was relatively high in hospitals at the county level and above as well as in cities with relatively low density of health care workforce. Our results also provided some evidence for the effectiveness of health care reform policies like the essential medicines programme in reducing overuse.

Protocol for a nationwide survey of primary health care in China: the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) MPP (Million Persons Project) Primary Health Care Survey

IntroductionChina has pioneered advances in primary health care (PHC) and public health for a large and diverse population. To date, the current state of PHC in China has not been...

Thirty Years of Essential Medicines

Behind the simple description of essential medicines as those that meet the real health needs of the population, is one of the biggest revolutions of the last decades. The essential medicines’ concept encompasses those medicines that meet people’s real health needs as well as the cost-containment of pharmaceutical products. As a result, it has been a contentious issue throughout the three decades of its existence. The World Health Organization’s Essential Medicines Programme, a firm promoter of access to medicines as a human right, has been the subject of numerous debates, the most recent surrounding the impact of intellectual property on access to medicines. This book is the first historical summary of the last thirty years of essential medicines. The book calls for the essential medicines’ concept to be put into action and identifies the current and future obstacles to making access to essential medicines an effective human right.

Access to and quality use of non-communicable diseases medicines in Nepal.

Noncommunicable diseases are a major healthcare problem in Nepal and their burden is increasingevery year. Noncommunicable diseases (NCDs) bring additional challenges to the Nepalese healthcaresystem which is already experiencing infrastructure shortages, poor service delivery, inadequate essential medicines coverage and shortages of healthcare workers. The Nepal government provides a limited number of free essential medicines through the free essential healthcare services program. This consists of a basic healthcare package provided through primary healthcare (PHC) facilities and district hospitals. Though around 40 essential medicines are provided without charge, studies have reported problems with access especially in all rural areas. There is a need to improve access to, coverage and quality use of medicines. The government has decided to provide some free medicines for NCDs alongside free essential medicines to be distributed via current healthcare structures. Though well intended, this decision will put extra strain on the essential medicines program. It should be supplemented by a comprehensive NCDs policy that takes account of the issues of sustainability and quality use of medicines. Complex cases of NCDs will be managed by tertiary hospitals but most of the cases of NCDs especially for rural people and the poor will end up in secondary level public hospitals (district and zonal hospitals). Therefore, the government needs to strengthen these public hospitals. Meanwhile, given the severity of the NCDs problem in Nepal, the Ministry of Health and Population (MoHP) should liaise with nongovernmental and missionary hospitals especially in rural areas to run NCDs management services. The Ministry should encourage these hospitals to run hospital pharmacies to improve people’s access to and quality use of NCDs medicines. At the primary healthcare level, the Ministry could run NCDs prevention and control programs but existing PHC workers need training to perform proper dispensing of NCDs medicines. PHC facilities need a medical record system so that they can address the needs of NCDs patients requiring long term medication supply via a proximate PHC facility.

The Cost-Effectiveness of Low-Cost Essential Antihypertensive Medicines for Hypertension Control in China: A Modelling Study.

BackgroundHypertension is China’s leading cardiovascular disease risk factor. Improved hypertension control in China would result in result in enormous health gains in the world’s largest population. A computer simulation model projected the cost-effectiveness of hypertension treatment in Chinese adults, assuming a range of essential medicines list drug costs.Methods and FindingsThe Cardiovascular Disease Policy Model-China, a Markov-style computer simulation model, simulated hypertension screening, essential medicines program implementation, hypertension control program administration, drug treatment and monitoring costs, disease-related costs, and quality-adjusted life years (QALYs) gained by preventing cardiovascular disease or lost because of drug side effects in untreated hypertensive adults aged 35–84 y over 2015–2025. Cost-effectiveness was assessed in cardiovascular disease patients (secondary prevention) and for two blood pressure ranges in primary prevention (stage one, 140–159/90–99 mm Hg; stage two, ≥160/≥100 mm Hg). Treatment of isolated systolic hypertension and combined systolic and diastolic hypertension were modeled as a reduction in systolic blood pressure; treatment of isolated diastolic hypertension was modeled as a reduction in diastolic blood pressure. One-way and probabilistic sensitivity analyses explored ranges of antihypertensive drug effectiveness and costs, monitoring frequency, medication adherence, side effect severity, background hypertension prevalence, antihypertensive medication treatment, case fatality, incidence and prevalence, and cardiovascular disease treatment costs. Median antihypertensive costs from Shanghai and Yunnan province were entered into the model in order to estimate the effects of very low and high drug prices. Incremental cost-effectiveness ratios less than the per capita gross domestic product of China (11,900 international dollars [Int$] in 2015) were considered cost-effective. Treating hypertensive adults with prior cardiovascular disease for secondary prevention was projected to be cost saving in the main simulation and 100% of probabilistic simulation results. Treating all hypertension for primary and secondary prevention would prevent about 800,000 cardiovascular disease events annually (95% uncertainty interval, 0.6 to 1.0 million) and was borderline cost-effective incremental to treating only cardiovascular disease and stage two patients (2015 Int$13,000 per QALY gained [95% uncertainty interval, Int$10,000 to Int$18,000]). Of all one-way sensitivity analyses, assuming adherence to taking medications as low as 25%, high Shanghai drug costs, or low medication efficacy led to the most unfavorable results (treating all hypertension, about Int$47,000, Int$37,000, and Int$27,000 per QALY were gained, respectively). The strengths of this study were the use of a recent Chinese national health survey, vital statistics, health care costs, and cohort study outcomes data as model inputs and reliance on clinical-trial-based estimates of coronary heart disease and stroke risk reduction due to antihypertensive medication treatment. The limitations of the study were the use of several sources of data, limited clinical trial evidence for medication effectiveness and harms in the youngest and oldest age groups, lack of information about geographic and ethnic subgroups, lack of specific information about indirect costs borne by patients, and uncertainty about the future epidemiology of cardiovascular diseases in China.ConclusionsExpanded hypertension treatment has the potential to prevent about 800,000 cardiovascular disease events annually and be borderline cost-effective in China, provided low-cost essential antihypertensive medicines programs can be implemented.

The effect of essential medicines programme on rational use of medicines in China.

Irrational use of medicines is a serious problem in China and has been the primary target of China's national essential medicines programme (NEMP). The aim of this study was to evaluate the effect of the NEMP on rational use of medicines in China. A nationwide sample of 3 76 700 prescriptions written by primary care providers from 2007 to 2011 was obtained following a multistage sampling process. Six prescribing indicators were measured: average number of drugs prescribed per prescription, average expenditure per prescription, percentage of prescriptions with antibiotics, with injections, with two or more antibiotics and with corticosteroids. The pre-post with control study design and the difference-in-difference (DID) methodology were employed to evaluate the effect of NEMP. Prescriptions from primary care institutions with the NEMP implementation were better than those without NEMP implementation. Adjusting for the institution's sizes, ownership, economic geographic regions and the year of NEMP implementation, the DID estimator was statistically significant in all prescribing indicators except for the percentage of prescriptions with injection. The number of drugs per prescription decreased by 0.2 per prescription [95% confidence interval (CI): -0.3, -0.1] after the NEMP was implemented; the percentages of prescriptions with antibiotics, with corticosteroids and with two or more antibiotics decreased by 7% (95% CI: -10, -4), 1% (95% CI: -2, 0) and 2% (95% CI: -3, 0), respectively; and the average expenditure per prescription decreased by eight Renminbi Yuan (95% CI: -14, -2). The effect of NEMP on reducing irrational prescribing was greater in public institutions than in private institutions (P < 0.05). China's NEMP is effective in promoting rational use of medicines, and the effect is greater in public institutions than in private institutions. However, the irrational use is still high, pointing to the need for further reforms to tackle the underlying causes, such as clinical guidelines and patient education.

Does Economic Incentive Matter for Rational Use of Medicine? China’s Experience from the Essential Medicines Program

Before the new round of healthcare reform in China, primary healthcare providers could obtain a fixed 15 % or greater mark-up of profits by prescribing and selling medicines. There were concerns that this perverse incentive was a key cause of irrational medicine use. China's new Essential Medicines Program (EMP) was launched in 2009 as part of the national health sector reform initiatives. One of its core policies was to eliminate primary care providers' economic incentives to overprescribe or prescribe unnecessarily expensive drugs, which were regarded as consequences of China's traditional financing system for health institutions. The objective of the study was to measure changes in prescribing patterns in primary healthcare facilities after the removal of the economic incentives for physicians to overprescribe as a result of the implementation of the EMP. A comparison design was applied to 8,258 prescriptions in 2007 and 8,278 prescriptions in 2010, from 83 primary healthcare facilities nationwide. Indicators were adopted to evaluate medicine utilization, which included overall number of medicines, average number of Western and traditional Chinese medicines, pharmaceutical expenditure per outpatient prescription, and proportion of prescriptions that contained two or more antibiotics. We further assessed the use of medicines (antibiotics, infusion, hormones, and intravenous injection) per disease-specific prescription for hypertension, diabetes, coronary artery heart disease, bronchitis, upper respiratory tract infection, and gastritis. A difference-in-difference analysis was employed to evaluate the net policy effect. Overall changes in indicators were not found to be statistically significant between the 2 years. The results varied for different diseases. The number of Western drugs per outpatient prescription decreased while that of traditional Chinese medicines increased. Overuse of antibiotics remained an extensive problem in the treatment of many diseases, though there was some significant improvement in certain diseases, like diabetes in rural areas. Medicine expenditure per prescription also decreased. It seems that the removal of a perverse economic incentive alone would not lead to improvement of healthcare providers' prescribing patterns. The rationality of the Essential Medicines List and the lack of payers' and providers' meaningful involvement in the development of the policy possibly contribute to the lack of significant changes in prescribing behaviors. It is suggested that China should adopt more comprehensive policies for healthcare facilities, physicians, patients, and payers, rather than just relying on economic incentives to improve rational use of medicines.

Better Guidance Is Welcome, but without Blinders

The three-paper series on guidance for evidence-informed decisions about health systems, published in PLoS Medicine, and produced by members of the World Health Organization (WHO) Task Force on Developing Health Systems Guidance, offers important contributions to improving the quality of evidence-informed decision-making in health systems [1–3]. We recognize the importance of engendering greater structure and systematization in processes that collate and evaluate evidence, and bring it to bear on policy. However, there are significant challenges in doing this for policies related to health systems, and we caution against the adoption of rigid approaches to the development of guidance and to the application of evidence to policy. In recognizing the growing international consensus on the importance of strengthening health systems, particularly in lowand middle-income-countries (LMICs), the first paper argues that better guidance is needed to provide evidenceinformed decisions about interventions in health systems, analogous to the methods that have been used to develop clinical guidelines, and facilitate their implementation [1]. The second paper seeks to identify a series of practical processes and tools for policy development at international and national levels, and for developing guidance at the national level [2]. Many of the same authors have developed the Supporting Policy Relevant Trials (SUPPORT) tools [6] that provide a basis for a very systematic approach to organizing questions about health systems problems and decisions influenced by evidence (Tables 1–3 in [2]). The third paper attempts to adapt guidelines used in clinical evidence-based medicine to understand the quality of health systems evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria [3,7]. In the first paper, Xavier Bosch-Capblanch et al. identify multiple uses of guidance on health systems from a review of national policies and plans in LMICs, but for some of the guidance identified— such as the operational guidelines for procurement, human resource management, or planning and budgeting procedures— one wonders whether research evidence is critical. The authors offer little guidance as to where health systems guidance is most needed. Given the fairly resource-intensive approach proposed to producing health systems guidance a clear sense of priorities is required, and a recognition that sometimes adherence to ‘‘best practice’’ may be sufficient. The papers pay relatively little attention to the well known ‘‘policy-implementation gap’’, and sometimes appear to presume that getting policy right is sufficient. The WHO essential medicines program has encountered significant success in promoting the widespread adoption of an extensive set of guidelines (at global, national, and local levels) related to the development of evidence-based policies, institutions, and procedures [4]. Over 150 countries have adopted essential medicines lists based on thoughtful and evidence-informed guidance [5]. Yet, despite this significant success, policy implementation of essential medicines programs continues to face enormous challenges, with widespread irrational medicines use and a growing threat of counterfeit medicines. In practice, policy development is rarely a one-time event, but is rather a continuous process. National-level policy decisions may provide the overarching framework for change, but commonly the details of policy change are worked out on the ground through implementation processes and reflected in more informal expressions of policy such as ministerial memos and training manuals. While the second paper [2] in the series, by John Lavis et al., portrays a relatively clean process of interaction between global guidance and national guidance and policy, in practice there are likely to be multiple policy iterations as problems and issues merge. Accordingly, while establishing structured processes to promote evidence use, we must not lose sight of the importance of building networks of researchers and policy makers to facilitate ongoing dynamic interaction. The authors of the third paper, Simon Lewin et al., note that systematic evidence is needed to address questions of feasibility and acceptability of interventions, as well as effectiveness, though much of the discussion in the paper addresses evidence regarding ‘‘what can work’’, a question for which GRADE criteria function well. But policy makers may be more interested in questions such as ‘‘what can work in our (non-research) environment?’’, ‘‘how can we make an intervention work well?’’, or ‘‘how can we overcome obstacles to implementation in our situation?’’ They are also likely to be more concerned about the broader type of unintended consequences of an intervention (e.g., the political ramifications) [8], the type of results that are often not well examined by typical research on ‘‘what can work’’. These

Making the List: The Role of Essential Medicines Lists In Reproductive Health

After immunization for common childhood illnesses, appropriate use of essential medicines is one of the most cost-effective components of modern health care. (1) Many interventions for communicable and noncommunicable diseases and conditions that threaten maternal and child health rely on the use of these high-quality medicines. (2) In 1977, the World Health Organization (WHO) developed its first model list of essential medicines to provide governments with a guide for selecting the drugs and medical devices that best address public health needs. (2) National essential medicines lists give priority status to the medicines necessary to treat a country's most pressing public health problems. By focusing public sector medicine procurement and treatment on this limited set of essential medicines, resources will be maximized. The lists are, in short, a vital tool for improving and maintaining health. As a result, for more than three decades, WHO has devoted substantial effort to an essential medicines program that seeks to improve access to the most needed drugs and devices. This comment examines the development of essential medicines lists--both the WHO model list and those compiled by individual countries. We discuss the place devices and medicines for reproductive health occupy on national lists and the importance of their inclusion in reducing the burden of disease attributable to reproductive health problems. We also review the process of establishing essential medicines lists, give examples of their use at the country level, and provide insight into their potential for ensuring access to medicines and devices for reproductive health. Our assessment draws on multiple sources of information, including WHO guidelines on essential medicines, data collected by individual countries, and work completed by WHO, the United Nations Population Fund (UNFPA) and PATH as part of our joint development of a guide to the essential medicines list selection process at the country level. Determining the WHO Model List The idea behind the lists was, and remains, that the use of a limited number of proven, essential medicines leads to better health care, improved supply, lower costs, and broader and more equitable access to products. (1) Some 30 years later, national essential medicines lists are in place in most WHO member states. (2) They provide support for national policies regarding the use and availability of medicines and promote primary health care by providing a rationale for the selection and use of medicines and their cost. Every two years, WHO convenes a committee on the selection and use of essential medicines with experts from around the world in such fields as medicine, pharmacology, medicines policy and medicines regulation, as well as other health organizations. The expert committee updates the model list to reflect changes in global health concerns, pharmaceutical developments and patterns of drug resistance. Applications for inclusions, changes or deletions to the model list can be prepared by outside institutions, but must be sponsored or submitted by someone within a WHO program. These applications are intended to be evidence-driven and must explain why a specific drug meets the model list's criteria for acceptance. The criteria take into account disease prevalence, evidence of efficacy and safety, and comparative cost-effectiveness. Applications include the names of the submitting or supporting WHO representative and of organizations consulted in preparing and supporting the application. (3) The 18th Expert Committee on the Selection and Use of Essential Medicines will be held March 21-25, 2011. The most recent WHO model list (http://www.who.int/selection_medicines/committees/expert/17/sixteenth_adult_list_en.pdf) was revised in March 2009 and identifies 340 medicines that address conditions that include malaria, HIV/AIDS, diabetes and cancer. (2) Organized by category of medication (for example, oxytocics is a category, as is antioxytocics), the model list identifies specific drugs by generic names, such as misoprostol and nifedipine. …

Rare essentials drugs for rare diseases as essential medicines

Since 1977, the WHO Model List of Essential Medicines (EML), published by WHO, has provided advice for Member States that struggle to decide which pharmaceutical technologies should be provided to patients within their public health systems. Originating from outside WHO, an incentive system has been put in place by various governments for the development of medicines for rare diseases ("orphan drugs"). With progress in pharmaceutical research (e.g. drugs targeted for narrower indications), these medicines will feature more often on future public health agendas. However, when current definitions for selecting essential medicines are applied strictly, orphan drugs cannot be part of the WHO Essential Medicines Programme, creating the risk that WHO may lose touch with this field. In our opinion WHO should explicitly include orphan drugs in its policy sphere by composing a complementary Orphan Medicines Model List as an addition to the EML. This complementary list of "rare essentials" could aid policy-makers and patients in, for example, emerging countries to improve access to these drugs and stimulate relevant policies. Furthermore, inconsistencies in the current EML with regard to medicines for rare diseases can be resolved. In this paper we propose selection criteria for an Orphan Medicines Model List that could form a departure point for future work towards an extensive WHO Orphan Medicines Programme.

Are drugs for rare diseases essential?

In 1977, the first report of the WHO Expert Committee on the Use of Essential Drugs defined essential drugs as those needed to satisfy the health-care needs of the majority of the population. This was done in order to fulfil a mandate to assist Member States in selecting and obtaining essential medicaments for their populations. The Expert Committee then developed criteria for determining if a drug fitted this definition and published a Model List of Essential Drugs as an example of how the concept of essential drugs could be implemented. A brief review of the state of medications at that time explains the need for this assistance: resources were limited in many countries, so the goal was to use them wisely, and many drugs marketed around the world were ineffective or irrational combination products. A review of the evidence of efficacy of all prescription drugs on the market in the United States starting in 1966 found that about one-third of the over 3000 marketed drugs were not effective. (1) In addition, there were frequently several effective drugs in the same therapeutic class: all did not need to be stocked by health service pharmacies. The essential drugs concept and the methods for its implementation were developed to help make decisions about which drugs to purchase to make the best use of the available health-care resources. WHO reported that, by the end of 1999, 156 Member States had medicine lists indicating acceptance of the essential medicines concept. Furthermore, there are a number of published examples of the favourable impact of this concept on various regions in the world. (2) While the procedures used by this WHO activity have evolved over time, (3) the definition of an essential medicine continues to be a medicine needed for the majority of the population. This appears to exclude systematically medicines for rare diseases. Is it time to change the definition? In this issue, Stolk et al. identify changes in the policies of some governments to facilitate the discovery and development of drugs for uncommon diseases. They propose an additional complementary Orphan Medicines Model List to include drugs for rare diseases in the Essential Medicines programme of WHO. (4) They propose seven criteria for including a drug in their suggested list; cost is not one of them. How should treatments for uncommon or rare diseases be considered, if at all, for an essential medicines list? After all, there are more than 6000 rare diseases and related conditions listed on the National Institutes of Health web site. (5) Aristotle raised the principle of distributive justice, the proper distribution of benefits and burdens, to address this question. (6) Is it right for one patient to benefit from a health service and another patient to be ignored only because of the prevalence of their illnesses? Is there a better way to select which medicines to purchase than to purchase only those for common problems? Are patients with rare diseases irrelevant to the health-care needs of a population? One way to make decisions about resource allocation is through cost--effectiveness analysis. …

Essential medicines and human rights: what can they learn from each other?

Most countries have acceded to at least one global or regional covenant or treaty confirming the right to health. After years of international discussions on human rights, many governments are now moving towards practical implementation of their commitments. A practical example may be of help to those governments who aim to translate their international treaty obligations into practice. WHO's Essential Medicines Programme is an example of how this transition from legal principles to practical implementation may be achieved. This programme has been consistent with human rights principles since its inception in the early 1980s, through its focus on equitable access to essential medicines. This paper provides a brief overview of what the international human rights instruments mention about access to essential medicines, and proposes five assessment questions and practical recommendations for governments. These recommendations cover the selection of essential medicines, participation in programme development, mechanisms for transparency and accountability, equitable access by vulnerable groups, and redress mechanisms.