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Substandard and Falsified Medicines: Proposed Methods for Case Finding and Sentinel Surveillance.

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.

SUBMITTER: Pisani E

PROVIDER: S-EPMC8406122 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSubstandard and falsified medical products present a serious threat to public health, especially in low- and middle-income countries. Their identification using pharmacopeial analysis is expensive and requires sophisticated equipment and highly trained personnel. Simple, low-cost technologies are required in addition to full pharmacopeial analysis in order to accomplish widespread routine surveillance for poor-quality medicines in low- and middle-income countries.MethodsTen faith-based drug supply organizations in seven countries of Africa and Asia were each equipped with a Minilab of the Global Pharma Health Fund (GPHF, Frankfurt, Germany), suitable for the analysis of about 85 different essential medicines by thin-layer chromatography. Each organization was asked to collect approximately 100 medicine samples from private local medicine outlets, especially from the informal sector. The medicine samples were tested locally according to the Minilab protocols. Medicines which failed Minilab testing were subjected to confirmatory analysis in a WHO-prequalified medicine quality control laboratory in Kenya.ResultsOut of 869 medicine samples, 21 were confirmed to be substandard or falsified medical products. Twelve did not contain the stated active pharmaceutical ingredient (API), six contained insufficient amounts of the API, and three showed insufficient dissolution of the API. The highest proportion of substandard and falsified medicines was found in Cameroon (7.1%), followed by the Democratic Republic of Congo (2.7%) and Nigeria (1.1%). Antimalarial medicines were most frequently found to be substandard or falsified (9.5% of all antimalarials). Thin-layer chromatography according to the Minilab protocols was found to be specific and reproducible in the identification of medicines which did not contain the stated API. Since only samples which failed Minilab testing were subjected to confirmatory testing using pharmacopeial methods, this study did not assess the sensitivity of the Minilab methodology in the detection of substandard medicines, and may underestimate the prevalence of poor-quality medicines.ConclusionsSurveillance for poor-quality medicines can be carried out by local organizations in low- and middle-income countries using a simple, low-cost technology. Such surveillance can identify an important subgroup of the circulating substandard and falsified medical products and can help to prevent them from causing harm in patients. A collaboration of the national drug regulatory authorities with faith-based organizations and other NGOs may therefore represent a promising strategy towards the Sustainable Development Goal of "ensuring access to quality medicines".

Project description:BACKGROUND:The influx of substandard and falsified medicines is a global public health challenge and its rapid detection is a key solution to the menace. This study used three screening methods and one confirmatory method for the quality assessment of 25 batches of artemether/lumefantrine dosage forms from the Ghanaian market to test that combined screening methods only can rapidly detect substandard and/or falsified medicines in areas where confirmatory methods may not be available. METHODS:The quality of artemether/lumefantrine tablet products obtained from pharmacies and licensed chemical seller shops within the Accra metropolis in Ghana were analysed using three screening methods (GPHF Minilab, Colorimetry and Counterfeit Drug Indicator) and one confirmatory method (high-performance liquid chromatography). RESULTS:The results showed that 18/25 batches of the artemether/lumefantrine samples passed using the combined screening and confirmatory methods and 5/25 batches of the artemether/lumefantrine samples failed using the combined screening and confirmatory methods. However, 1/25 batch of the artemether/lumefantrine samples failed using the combined screening methods but passed using the confirmatory method. Also, 1/25 batch of the artemether/lumefantrine samples passed using the combined screening methods but failed using the confirmatory method. This notwithstanding, the combined screening methods and the confirmatory method provided equivalent quality assessment profiles for 23/25 (92%) batches of the artemether/lumefantrine tablet products. Out of the 6 samples that failed the confirmatory test, 1/6, 2/6, and 3/6 failed on the high (> 110%), low (< 90%), and no active ingredient (0%), respectively. The sensitivity of Minilab, colorimetric, CoDI, and the combined screening methods at 95% confidence level were 0.5 ± 0.57, 0.83 ± 0.33, 0.75 ± 0.49, and 0.83 ± 0.33, respectively. Also, the specificity of Minilab, colorimetric, CoDI, and the combined screening methods at 95% confidence level were 1.00, 0.95 ± 0.10, 1.00, and 0.95 ± 0.10, respectively. CONCLUSION:The combined screening methods may be used for rapid detection of falsified and/or substandard medicines without using a confirmatory method. However, additional research on the best combinations of screening devices/methods to rapidly detect the quality of medicines is recommended.

Project description:Introduction: Substandard and falsified medicines undermine health systems. We sought to unravel the political and economic factors which drive the production of these products, and to explain how they reach patients. Methods: We conducted in-depth case studies in China, Indonesia, Turkey and Romania. We reviewed academic papers and press reports (n = 840), developing semi-structured questionnaires. We interviewed regulators, policy-makers, pharmaceutical manufacturers, physicians, pharmacists, patients and academics (n=88). We coded data using NVivo software, and developed an analytic framework to assess national risks for substandard and falsified medicines. We tested the framework against cases reported to the World Health Organization, from countries at all income levels. Results: We found that increasing political commitment to provision of universal health coverage has led to public procurement policies aimed at lowering prices of medical products. In response, legitimate, profit-driven pharmaceutical companies protect their margins by cutting costs, or withdrawing from less profitable markets, while distributors engage in arbitrage. Meanwhile, health providers sometimes protect profits by 'upselling' patients to medicines not covered by insurers. Cost-cutting can undermine quality assurance, leading to substandard or degraded medicines. Other responses contribute to shortages, irrational demand and high prices. All of these provide market opportunities for producers of falsified products; they also push consumers outside of the regular supply chain, providing falsifiers with easy access to customers. The analytic framework capturing these interactions explained cases in most high and middle-income settings; additional factors operate in the poorest countries. Conclusions: Most efforts to secure medicine quality currently focus on product regulation. However, our research suggests market mechanisms are key drivers for poor quality medicines, including where political commitments to universal health coverage are under-resourced. We have developed a framework to guide country-specific, system-wide analysis. This can flag risks and pinpoint specific actions to protect medicine quality, and thus health.

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Substandard and Falsified Medicines: Proposed Methods for Case Finding and Sentinel Surveillance.

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