Protocol deviations in medicine quality tests
Year: 2025
Type: article
Abstract: National, regional and international pharmacopoeias set standards for the quality of medicines and provide instructions for testing to ensure those standards are met. Medicines, tests, standards and methods all vary among the more than 60 pharmacopoeias currently in use. These publications were developed mainly to regulate medicine manufacturing, where safety is essential and methods are generally complex. These methods require sophisticated equipment, specific materials and high levels of skill, and can generate large quantities of pharmaceutical waste. However, pharmacopoeias are also used to guide medicine quality testing for other purposes and in other settings. Notably, they are used in post-marketing surveillance and research on medicine quality in low- and middle-income countries where the prevalence of substandard and falsified medicines is thought to be highest. Regulators and other researchers in these settings may not have access to all the equipment, materials and skills needed to follow pharmacopoeias exactly. Therefore, they often develop work-arounds, which are rarely acknowledged or described when reporting results. Our experience using modified methods for testing amoxicillin tablets in Indonesia suggests that necessary work-arounds can significantly distort study outcomes, potentially leading to misguided policy responses. We argue that standard-setting bodies should recognize challenges to testing in research and surveillance contexts in resource-constrained settings where patient safety is not at immediate risk. These bodies should provide evidence-based guidance on low-cost, environmentally sustainable modifications to industry-standard testing methods for use in these contexts. The research community must inform this guidance, providing details of modifications and their outcomes, both successful and unsuccessful.
Institutions: Pancasila University, Equilab International (Indonesia)
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4417523860
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