Be-cause Health & QUAMED literature updates
Ref: World Health Organization. Regulatory guidance for assessment and management of applications for marketing authorization of oxytocin. WHO 2021. ISBN 978-92-4-002213-3 (electronic version).
Today, I would like to share a WHO regulatory document concerning the quality of oxytocin-containing products. You can download it at this link:
While the part starting in page 13 is technical, and of interest for regulators, manufacturers and inspectors, chapter 1 will be of interest for most of us, as postpartum hemorrhage needs to be treated with quality-assured medicines, but unfortunately studies have identified high rates of substandard oxytocin in many LMICs, both in registered and unregistered products. The primary causes are poor-quality manufacturing and/or product degradation in the supply chain: oxytocin needs to be stored at 2°C–8°C to ensure efficacy and potency, yet many products circulating in LMICs are not labelled or stored accordingly. In chapter 1, you will find an interesting overview of cases of poor-quality oxytocin, with a reflection on their causes. Yu may use this information to get a better understanding of poor-quality medicines, and/or to get material useful for teaching or raising awareness about it. And, of course, it will also be useful for pharmaceutical purchasers.
I also take this opportunity to share a new update of our informal Fact-Sheet on poor quality medicines (attached).
Last not least … I am happy to remind 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
Have a nice reading, and please share with concerned colleagues!