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  1. Article: Challenges in maintaining medicine quality while aiming for universal health coverage: a qualitative analysis from Indonesia.

    Hasnida, Amalia / Kok, Maarten Olivier / Pisani, Elizabeth

    BMJ global health

    2021  Volume 6, Issue Suppl 3

    Abstract: Introduction: Indonesia, the world's fourth most populous nation, is close to achieving universal health coverage (UHC). A widely-publicised falsified vaccine case in 2016, coupled with a significant financial deficit in the national insurance system, ... ...

    Abstract Introduction: Indonesia, the world's fourth most populous nation, is close to achieving universal health coverage (UHC). A widely-publicised falsified vaccine case in 2016, coupled with a significant financial deficit in the national insurance system, has contributed to concern that the rapid scale-up of UHC might undermine medicine quality. We investigated the political and economic factors that drive production and trade of poor-quality medicines in Indonesia.
    Methods: We reviewed academic publications, government regulations, technical agency documents and news reports to develop a semi-structured questionnaire. We interviewed healthcare providers, policy-makers, medicine regulators, pharmaceutical manufacturers, patients and academics (n=31). We included those with in-depth knowledge about the falsified vaccine case or the pharmaceutical business, medicine regulation, prescribing practice and the implementation of UHC. We coded data using NVivo software and analysed by constant comparative method.
    Results: The scale-up of UHC has cut revenues for physicians and pharmaceutical manufacturers. In the vaccine case, free, quality-assured vaccines were available but some physicians, seeking extra revenue, promoted expensive alternatives. Taking advantage of poor governance in private hospitals, they purchased cut-price 'vaccines' from freelance salespeople.A single-winner public procurement system which does not explicitly consider quality has slashed the price paid for covered medicines. Trade, industrial and religious policies simultaneously increased production costs, pressuring profit margins for manufacturers and distributors. They reacted by cutting costs (potentially threatening quality) or by market withdrawal (leading to shortages which provide a market for falsifiers). Shortages and physician-promoted irrational demand push patients to buy medicines in unregulated channels, increasing exposure to falsified medicines.
    Conclusion: Market factors, including political pressure to reduce medicine prices and healthcare provider incentives, can drive markets for substandard and falsified medicines. To protect progress towards UHC, policy-makers must consider the potential impact on medicine quality when formulating rules governing health financing, procurement, taxation and industry.
    MeSH term(s) Government Regulation ; Healthcare Financing ; Humans ; Indonesia ; Universal Health Insurance
    Language English
    Publishing date 2021-05-28
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2059-7908
    ISSN 2059-7908
    DOI 10.1136/bmjgh-2020-003663
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Substandard and Falsified Medicines: Proposed Methods for Case Finding and Sentinel Surveillance.

    Pisani, Elizabeth / Hasnida, Amalia / Rahmi, Mawaddati / Kok, Maarten Olivier / Harsono, Steven / Anggriani, Yusi

    JMIR public health and surveillance

    2021  Volume 7, Issue 8, Page(s) e29309

    Abstract: The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no ... ...

    Abstract The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low- and middle-income countries. However, no country has measured the market-wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk-based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case-finding system that uses secondary data to flag poor-quality medicines, proposing risk-based indicators that differ for substandard and falsified medicines. This system potentially offers a cost-effective way of identifying "cases" for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk-based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet-based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle-income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource-constrained settings.
    MeSH term(s) Commerce ; Counterfeit Drugs ; Humans ; Public Health ; Sentinel Surveillance
    Chemical Substances Counterfeit Drugs
    Language English
    Publishing date 2021-08-16
    Publishing country Canada
    Document type Journal Article
    ISSN 2369-2960
    ISSN (online) 2369-2960
    DOI 10.2196/29309
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative research in China, Indonesia, Turkey and Romania.

    Pisani, Elizabeth / Nistor, Adina-Loredana / Hasnida, Amalia / Parmaksiz, Koray / Xu, Jingying / Kok, Maarten Oliver

    Wellcome open research

    2019  Volume 4, Page(s) 70

    Abstract: Introduction: ...

    Abstract Introduction:
    Language English
    Publishing date 2019-04-16
    Publishing country England
    Document type Journal Article
    ISSN 2398-502X
    ISSN 2398-502X
    DOI 10.12688/wellcomeopenres.15236.1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Making health systems research work: time to shift funding to locally-led research in the South.

    Hasnida, Amalia / Borst, Robert A / Johnson, Anneke M / Rahmani, Nada R / van Elsland, Sabine L / Kok, Maarten O

    The Lancet. Global health

    2017  Volume 5, Issue 1, Page(s) e22–e24

    Language English
    Publishing date 2017-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 2723488-5
    ISSN 2214-109X ; 2214-109X
    ISSN (online) 2214-109X
    ISSN 2214-109X
    DOI 10.1016/S2214-109X(16)30331-X
    Database MEDical Literature Analysis and Retrieval System OnLINE

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