E-DRUG: Characterizing Medicine Quality by Active Pharmaceutical Ingredient Levels
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Dear E-druggers,
You may have already seen this open-access article, recently published by Ozawa and colleagues:
Characterizing Medicine Quality by Active Pharmaceutical Ingredient Levels: A Systematic Review and Meta-Analysis across Low- and Middle-Income Countries in: The American Journal of Tropical Medicine and Hygiene Volume 106 Issue 6 (2022) (ajtmh.org)<https://www.ajtmh.org/view/journals/tpmd/106/6/article-p1778.xml>
The authors state that "falsified medicines dealing with criminal activity tend to attract more attention than substandard medicines" but "that both substandard and falsified medicines pose a threat to public health", and it is "critical to direct resources at them differently".
I am copy-pasting here the abstract:
Substandard and falsified medicines are often reported jointly, making it difficult to recognize variations in medicine quality. This study characterized medicine quality based on active pharmaceutical ingredient (API) amounts reported among substandard and falsified essential medicines in low- and middle-income countries (LMICs).
A systematic review and meta-analysis was conducted using PubMed, supplemented by results from a previous systematic review, and the Medicine Quality Scientific Literature Surveyor.
Study quality was assessed using the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). Random-effects models were used to estimate the prevalence of medicines with < 50% API. Among 95,520 medicine samples from 130 studies, 12.4% (95% confidence interval [CI]: 10.2 - 14.6%) of essential medicines tested in LMICs were considered substandard or falsified, having failed at least one type of quality analysis.
We identified 99 studies that reported API content, where 1.8% (95% CI: 0.8 - 2.8%) of samples reported containing < 50% of stated API.
Among all failed samples (N = 9,724), 25.9% (95% CI: 19.3-32.6%) reported having < 80% API. Nearly one in seven (13.8%, 95% CI: 9.0-18.6%) failed samples were likely to be falsified based on reported API amounts of < 50%, whereas the remaining six of seven samples were likely to be substandard. Furthermore, 12.5% (95% CI: 7.7-17.3%) of failed samples reported finding 0% API.
Many studies did not present a breakdown of actual API amount of each tested sample. We offer suggested improved guidelines for reporting poor-quality medicines. Consistent data on substandard and falsified medicines and medicine-specific tailored interventions are needed to ensure medicine quality throughout the supply chain.
Raffaella Ravinetto
Institute of Tropical Medicine
Antwerp, Belgium
Raffaella Ravinetto <rravinetto@itg.be>