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通过推广仿制药来改善药物的可及性:马哈拉施特拉邦两个地区“印度人民药物”计划的研究。

Improving access to medicines by popularising generics: a study of 'India's People's Medicine' scheme in two districts of Maharashtra.

机构信息

School of Health Systems Studies, Tata Institute of Social Sciences, Mumbai, India.

Centre for Health Policy, Planning and Management, School of Health Systems Studies, Tata Institute of Social Sciences, Mumbai, India.

出版信息

BMC Health Serv Res. 2022 May 13;22(1):643. doi: 10.1186/s12913-022-08022-1.

DOI:10.1186/s12913-022-08022-1
PMID:35562697
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9107149/
Abstract

BACKGROUND

In spite of being the 'pharmacy of the world', access to essential medicines for a large majority of Indians is constrained by both physical and financial reasons. According to an estimate, medicines account for 69% of household out-of-pocket spending on health care. To make quality generic medicine affordable, India's People's Medicine Scheme (Jan Aushadhi) was launched in 2008 and then revamped and rebranded as Pradhan Mantri Bhartiya Jan Ausadhi Pariyojana (PMBJP) in 2015. The current study focuses on the availability, affordability and acceptability aspects of PMBJP essential medicines.

METHODS

We have used a mixed-methods approach, with the survey-based quantitative component supplemented by a qualitative component consisting of in-depth interviews (IDIs). The survey was conducted in 11 PMBJP pharmacies in Mumbai and Palghar. Data were gathered on the availability, stock-outs, price and affordability of 35 essential medicines and 2 consumables.

RESULTS

Apart from the limited coverage of essential medicines and the significant presence of Fixed dose combinations (FDCs) in the PMBJP medicine list, the availability of surveyed essential drugs was also found to be low (47%) in PMBJP outlets. Across Mumbai and Palghar districts, around 50% and 42% of medicines were found to be out of stock for the period of 3-6 months respectively. The cost of generic medicines of PMBJP outlets for treating various conditions range from 0.01 days' wages to 0.47 days' wages for the lowest paid unskilled worker in Maharashtra.

CONCLUSIONS

The study findings show that PMBJP's unbranded generics offer great opportunities for substantial cost savings. But, in order to fully realise the potential of this scheme, some policy actions are urgently required. First, the PMBJP drug list must include all essential drugs that feature in NLEM. Second, BPPI should procure only those drugs that pass the bioequivalence test. Third, compulsory de-branding of generics should be done in a phased manner. Fourth, PMBJP's medicine procurement and distribution policies must be reviewed to address the supply chain issues. Moreover, there is a need for major pharmaceutical policy reforms to promote generic medicines in a big way. Regulations to support mandatory generic prescribing and generic substitution by pharmacists are needed.

摘要

背景

尽管印度是“世界药房”,但大多数印度人获取基本药物仍受到经济和实际条件的限制。据估计,药品占家庭医疗保健支出的 69%。为了降低高质量仿制药的价格,印度于 2008 年推出了人民药房计划(Jan Aushadhi),后于 2015 年对其进行了调整并重新命名为总理廉价药品供应计划(PMBJP)。本研究重点关注 PMBJP 基本药物的可及性、可负担性和可接受性。

方法

我们采用了混合方法,在基于调查的定量部分之外,还补充了定性部分,包括深入访谈(IDIs)。该调查在孟买和帕尔加尔的 11 家 PMBJP 药房进行。收集了 35 种基本药物和 2 种耗材的供应情况、缺货情况、价格和可负担性的数据。

结果

除了基本药物覆盖范围有限以及 PMBJP 药物清单中存在大量固定剂量组合(FDCs)外,调查中基本药物的供应也发现很低(47%)。在孟买和帕尔加尔地区,分别有 50%和 42%的药品在 3-6 个月期间缺货。PMBJP 药房治疗各种疾病的通用药物的费用范围为马哈拉施特拉邦最低工资非熟练工人 0.01 天工资至 0.47 天工资。

结论

研究结果表明,PMBJP 的无品牌仿制药为大幅节省成本提供了巨大机会。但是,为了充分发挥该计划的潜力,迫切需要采取一些政策行动。首先,PMBJP 药物清单必须包含 NLEM 中列出的所有基本药物。其次,BPPI 应仅采购通过生物等效性测试的药物。第三,应分阶段强制取消仿制药的品牌。第四,必须审查 PMBJP 的药品采购和分销政策,以解决供应链问题。此外,还需要进行重大的药品政策改革,以大力推广仿制药。需要制定支持药剂师强制性开仿制药处方和替代仿制药的法规。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/a545749475df/12913_2022_8022_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/6ebf6938a403/12913_2022_8022_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/cb78e3a9aa3b/12913_2022_8022_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/4423f9858468/12913_2022_8022_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/db5860dd7f41/12913_2022_8022_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/a545749475df/12913_2022_8022_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/6ebf6938a403/12913_2022_8022_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/cb78e3a9aa3b/12913_2022_8022_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/4423f9858468/12913_2022_8022_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/db5860dd7f41/12913_2022_8022_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9537/9107149/a545749475df/12913_2022_8022_Fig5_HTML.jpg

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