E-DRUG: Social and ethical issues of poor quality and poor use of medical products: a special issue in BMJ Global Health
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Dear E-Druggers,
I am happy to share the link of the first batch of papers just published in the BMJ Global health on "Social and ethical issues of poor quality and poor use of medical products":
https://gh.bmj.com/content/6/Suppl_3/
This issue includes one "practice" manuscript from Katherine Enright:
Elusive quality: the challenges and ethical dilemmas faced by international non-governmental organisations in sourcing quality assured medical products <https://gh.bmj.com/content/6/Suppl_3/e004339> (28 May, 2021)
and three original research papers:
- Implementing pharmaceutical track-and-trace systems: a realist review <https://gh.bmj.com/content/6/Suppl_3/e003755>, by Joeke Kootstra, Tineke Kleinhout-Vliek
- Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania <https://gh.bmj.com/content/6/Suppl_3/e003043>, by Heather Hamill, Elizabeth David-Barrett, Joseph Rogathe Mwanga, Gerry Mshana, Kate Hampshire
- Challenges in maintaining medicine quality while aiming for universal health coverage: a qualitative analysis from Indonesia
<https://gh.bmj.com/content/6/Suppl_3/e003663>, by Amalia Hasnida, Maarten Olivier Kok, Elizabeth Pisani
Please note that the Special Issues is still open, so you can submit more contributions!
The abstracts of the four papers already published are copy-pasted under my signature.
With best wishes
Raffaella Ravinetto
Special Issue Guest Editor
Institute of Tropical Medicine Antwerp
Medicines Research & Policy Support
Raffaella Ravinetto <rravinetto@itg.be>
1. PRACTICE
Elusive quality: the challenges and ethical dilemmas faced by international non-governmental organisations in sourcing quality assured medical products
1. Katherine Enright
Although medical products that are of sound quality are fundamental to the delivery of healthcare, so too is their availability, affordability, accessibility and acceptability. However, achieving all of these aims consistently and simultaneously may be unfeasible due to a host of barriers-no matter the country. If uncertainty, constraints and conflicting priorities also threaten their delivery, not only does the situation becomes yet more challenging, the morally just course of action becomes yet more opaque. While global health organisations, supply chains and projects are heterogenous, international non-governmental organisations (iNGOs) responding to humanitarian crises or delivering development assistance in low-income and middle-income countries are undoubtedly prone to this issue. In a novel framing of the problem of substandard and falsified medicines, this article explores some ethical dilemmas that, directly or indirectly, could result in the quality of medical products in iNGO health projects to be compromised. Drawing on a broad literature base and years of experience as a senior humanitarian pharmacist, the author reflects on the barriers, culture and system that contributes to the existence and persistence of substandard and falsified medical products in global assistance projects.
The paper offers an in-depth examination of pressures that may arise in four key areas (capacity, supply chain, bureaucracy and quality assurance) and postulates on the myriad ways in which this may alter the attitudes, behaviours and decision-making of iNGOs in a manner that disincentivises the prioritisation of medical product quality. This paper does not seek to excoriate the aid sector, but rather to lend a new perspective: that such predicaments are overlooked, real-world ethical dilemmas in urgent need of greater openness, research, debate and guidance, for the benefit of moral decision-making and patient care.
2. Original research
Implementing pharmaceutical track-and-trace systems: a realist review
Joeke Kootstra, Tineke Kleinhout-Vliek
One way to prevent falsified medical products from entering the regulated pharmaceutical supply chain is to implement a pharmaceutical track-and-trace system (PTTS). Such systems in the most extensive versions generally mandate a scan at every point of contact with the medical product: from the point of entry to dispensation. There have been several attempts to implement such systems; for example, a 'full' PTTS in Turkey and the more pared-down version offered by the European Union's Falsified Medicines Directive and Delegated Act. This study aims to identify facilitators and barriers to implementing (elements of) a PTTS, with the Turkish system used as a benchmark. We conducted a 'realist' review, which synthesises literature and aims to establish how a specific technology works, for whom, under which circumstances. We searched Embase, Medline Ovid, Web of Science, Cochrane Central and Google Scholar databases, yielding 2,790 scholarly articles. We selected 21 for review. Implementation of PTTS elements has been attempted in different compositions in several primarily high-income and middle-income countries. Factors that affected implementation included stakeholders like the government and supply chain actors, the coordination between them, and their awareness, knowledge, and skills, as well as regulation and legislation, monetary investments, and technical and digital requirements. The interplay between contextual factors is crucial for successful PTTS implementation. Specifically, the findings indicate that aligning the incentives for all actors and allowing for adjustments in a continuous implementation process will likely facilitate implementation.
3. Original research
Monitoring, reporting and regulating medicine quality: tensions between theory and practice in Tanzania
1. Heather Hamill1<https://gh.bmj.com/content/6/Suppl_3/e003043#aff-1>,
Elizabeth David-Barrett2<https://gh.bmj.com/content/6/Suppl_3/e003043#aff-2>,
Joseph Rogathe Mwanga3<https://gh.bmj.com/content/6/Suppl_3/e003043#aff-3>, Gerry Mshana4<https://gh.bmj.com/content/6/Suppl_3/e003043#aff-4>,
Kate Hampshire5<https://gh.bmj.com/content/6/Suppl_3/e003043#aff-5>
2.In 2012, the WHO launched its Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines, with the aim of improving the quality of reporting and using the data to inform post-market surveillance and build regulatory capacity. However, from a regulatory governance perspective, its effectiveness depends on the willingness and ability of actors 'on the ground' to identify, report and investigate possible infringements and to enforce penalties.
This paper presents findings from 27 interviews with representatives of agencies charged with regulating pharmaceutical markets and 4 interviews with pharmaceutical industry representatives in Tanzania. Their experiences provide important insights into how the theorised mechanism between reporting and a reduction in undesirable behaviours can play out in a low-income context, revealing hidden assumptions about regulator behaviour and motivations. A combination of chronic under-resourcing, information gaps and enforcement challenges conspires to limit the efforts of local regulators to achieve the GSMS goals, shedding new light on the relationship between apparent 'misconduct' and structural constraints.
4. Original research
Challenges in maintaining medicine quality while aiming for universal health coverage: a qualitative analysis from Indonesia
Amalia Hasnida1<https://gh.bmj.com/content/6/Suppl_3/e003663#aff-1>,
2<https://gh.bmj.com/content/6/Suppl_3/e003663#aff-2>,
Olivier Kok1<https://gh.bmj.com/content/6/Suppl_3/e003663#aff-1>,
3<https://gh.bmj.com/content/6/Suppl_3/e003663#aff-3>, Elizabeth Pisani1<https://gh.bmj.com/content/6/Suppl_3/e003663#aff-1>,
4<https://gh.bmj.com/content/6/Suppl_3/e003663#aff-4>
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. 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. 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. 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.