The George Institute for Global Health, Hyderabad, India.
Global Health Section, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Glob Heart. 2024 Jul 1;19(1):56. doi: 10.5334/gh.1335. eCollection 2024.
The recent inclusion of polypills-fixed-dose combinations of antihypertensive medicines and a statin with or without aspirin-in the World Health Organization's Essential Medicines List (EML) reiterates the potential of this approach to improve global treatment coverage for cardiovascular diseases (CVDs). Although there exists extensive evidence on the effectiveness, safety and acceptability of polypills, there has been no research to date assessing the real-world availability and affordability of polypills globally.
We conducted a cross-sectional survey, based on the WHO/Health Action International methodology, in 13 countries around the world. In the surveyed countries, we first ascertained whether any polypill was authorised for marketing and/or included in EMLs and clinical guidelines. In each country, we collected retail and price data for polypills from at least one public-sector facility and three private pharmacies using convenience sampling. Polypills were considered unaffordable if the lowest-paid worker spent more than a day's wage to purchase a monthly supply.
Polypills were approved for marketing in four of the 13 surveyed countries: Spain, India, Mauritius and Argentina. None of these countries included polypills in national guidelines, formularies, or EMLs. In the four countries, no surveyed public pharmacies stocked polypills. In the private sector, we identified seven unique polypill combinations, marketed by eight different companies. Private sector availability was 100% in Argentina and Spain. Most combinations (n = 5) identified were in India. Combinations found in India and Spain were affordable in the local context. A lowest-paid government worker would spend between 0.2 (India) and 2.8 (Mauritius) days' wages to pay the price for one month's supply of the polypills. Polypills were likely to be affordable if they were manufactured in the same country.
Low availability and affordability of polypills in the public sector suggest that implementation remains poor globally. Context-specific multi-disciplinary health system research is required to understand factors affecting polypill implementation and to design and evaluate appropriate implementation strategies.
最近,世界卫生组织基本药物清单(EML)中纳入了复方固定剂量降压药和他汀类药物与或不与阿司匹林的复合制剂(即复方药),这再次强调了这种方法在改善全球心血管疾病(CVD)治疗覆盖率方面的潜力。尽管已有大量证据表明复方药有效、安全且可接受,但迄今为止,尚无研究评估全球范围内复方药的实际可得性和可负担性。
我们采用世界卫生组织/国际健康行动组织的方法,在全球 13 个国家进行了横断面调查。在调查的国家中,我们首先确定是否有任何复方药已获准上市和/或纳入 EML 和临床指南。在每个国家,我们使用便利抽样法,从至少一家公立医疗机构和三家私人药店收集复方药的零售价格数据。如果最低工资工人购买一个月的供应量需要花费一天以上的工资,则认为该药物不可负担。
在调查的 13 个国家中,有 4 个国家批准了复方药的上市:西班牙、印度、毛里求斯和阿根廷。这些国家均未将复方药纳入国家指南、处方集或 EML。在这四个国家,没有调查的公立药店储备有复方药。在私营部门,我们发现了由 8 家不同公司销售的 7 种独特的复方药组合。阿根廷和西班牙的私营部门复方药供应率为 100%。在印度发现的大多数组合(n=5)。在印度和西班牙发现的组合在当地是负担得起的。最低工资工人支付一个月供应量的价格需要花费 0.2(印度)到 2.8(毛里求斯)天的工资。如果复方药在本国生产,那么它们可能是负担得起的。
公共部门复方药的可得性和可负担性低表明全球实施情况仍然不佳。需要进行具体国情的多学科卫生系统研究,以了解影响复方药实施的因素,并设计和评估适当的实施策略。