210923 BCH/QUAMED: Quality of medical products for cardiovascular diseases
Ref: Do NT, Bellingham K, Newton PN, et al. The quality of medical products for cardiovascular diseases: a gap in global cardiac care. BMJ Global Health 2021;6:e006523. doi:10.1136/bmjgh-2021-006523
Today, I would like to share an important research paper from our IDDO friends in Oxford. The Authors reviewed the available literature on SF cardiovascular medicines/devices, with a focus on prevalence studies, but also including equivalence and stability studies, routine quality control analyses, bioavailability studies, reports of recalls and seizures, case reports, general discussions and reviews.
“Failure” was defined as the proportion of samples that failed at least one quality test described in the report. The observed frequency of failure was of 525 (15.4%) for the 3414 samples tested for quality in 27 prevalence surveys with sufficient information for inclusion in the quantitative analysis. Most samples included in prevalence surveys were collected from low-income and middle-income countries, and the most common defects were out-of-specification content of active ingredient(s); presence of impurity/contaminant; and impaired dissolution profile. Furthermore, reports were found of 26 quality incidents describing SF concerning cardiovascular devices, with 181 related deaths; however, differently than for medicines, no surveys were found that prospectively assess the quality of such devices…
Overall, the data suggest that substandard and falsified (SF) cardiovascular products are likely to be serious but neglected public health problems. The failure frequency of 15.4% observed in this research cannot be extrapolated as such to the global market, but it clearly indicates the “need for more research with robust methodology to provide more accurate prevalence estimates in order to inform policy and implement measures to ensure the quality of cardiovascular medicines and devices within the supply chain”, in order to ensure “that the benefits of therapy are realised in the prevention and treatment of CVDs”.
While wishing you a nice reading, I also take this opportunity to remind you that the second ITM short course on Pharmaceutical Policies in Health Systems will take place in Antwerp, from 30th May to 17th June 2022. Those interested can already apply now, and until the end of January 2022, at https://edu.itg.be/courses/pharmaceutical-policies-in-health-systems