An Analysis of Substandard Propofol Detected in Use in Zambian Anesthesia

Mumphansha, Hazel; Nickerson, Jason; Attaran, Amir; Overton, Sean; Curtis, Sharon; Mayer, Paul M.; Bould, M. Dylan

doi:10.1213/ane.0000000000002226

Cited by 17 publications

(6 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In August 2018 it was pointed out by the moderator of that newsletter that, according to the UK government website Companies House (https://beta. companieshouse.gov.uk/), the distributor Premiumway International was located at the same address, and managed by the same directors, as the company Unimed International Ltd. who had been reported to distribute poor-quality propofol (an anaesthetic medicine) to the government of Zambia [36,37]. In the ensuing correspondence, WHO asked the authors of this paper to send a sample of the misoprostol tablets distributed by Premiumway International to the British medicine regulatory authority (MHRA) for confirmatory analysis.…”

Section: Chemical Analysis Of Misoprostol Samplesmentioning

confidence: 99%

Quality, availability and storage conditions of oxytocin and misoprostol in Malawi

Hagen

Khuluza

Heide

2020

BMC Pregnancy Childbirth

View full text Add to dashboard Cite

Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-and middle-income countries (LMICs). Oxytocin and misoprostol are used for the prevention and treatment of PPH. However, both medicines are chemically unstable and sensitive to environmental conditions. Previous studies reported a high prevalence of substandard oxytocin and misoprostol preparations in LMICs. Methods: In randomly selected health facilities of four districts of Malawi, the availability of oxytocin and misoprostol was determined, and the knowledge of health workers on storage requirements and use of oxytocics was assessed. Temperature loggers were used to record the storage temperature of oxytocics. Samples of oxytocin injections and misoprostol tablets were collected from the health facilities and from wholesalers. Oxytocin samples were analysed for identity, assay (= quantity of oxytocin) and for pH value according to United States Pharmacopeia 40. Misoprostol samples were analysed for identity, assay, dissolution and related substances according to the International Pharmacopeia 2017. Results: All visited hospitals and health centers had oxytocin available. At non-refrigerated storage sites, the recorded mean kinetic temperature exceeded the oxytocic's storage temperature stated on the labels in 42% of the sites. At refrigerated storage sites, the required temperature of 2-8°C was exceeded in 33% of the sites. Out of 65 oxytocin samples, 7 (11%) showed moderate deviations from specification, containing 82.2-86.8% of the declared amount of oxytocin. Out of 30 misoprostol samples, 5 (17%) showed extreme deviations, containing only 12.7-30.2% of the declared amount. The extremely substandard misoprostol was reported to the national authorities and to WHO, leading to an immediate recall of the respective brand in Malawi. The UK-based distributor of this brand closed its business shortly thereafter. Conclusion: Availability of oxytocin was excellent in Malawi, and its quality was better than reported in previous studies in other LMICs. However, storage conditions at the health facilities often did not meet the requirements. Extremely substandard misoprostol tablets were found, representing a serious risk to maternal health. This shows the need for continued efforts for quality assurance in medicine procurement and registration, as well as for postmarketing surveillance.

show abstract

Section: Chemical Analysis Of Misoprostol Samplesmentioning

confidence: 99%

Quality, availability and storage conditions of oxytocin and misoprostol in Malawi

Hagen

Khuluza

Heide

2020

BMC Pregnancy Childbirth

View full text Add to dashboard Cite

show abstract

“…Reports of SF medications hail from all over the world, but primarily Africa and Asia. Many of these are for SF antibiotics, antiseizure medications, and sedatives, which are commonly used in the critical care setting [ 28 , 29 ]. Each of these classes of medications, when inadequately dosed or tampered with, can lead to adverse events.…”

Section: Global Contextmentioning

confidence: 99%

Substandard and Falsified Medications: A Barrier to Global Health Equity Exemplified in Ecuador

et al. 2022

View full text Add to dashboard Cite

Medicines have been developed and have become globalized at a pace faster than traditional medical education can keep up. Physicians, pharmacists, nurses, and advanced practice providers learn the names and functions of these medications, but not how they are made and how they get to the bedside. The often economically driven intricacies behind these processes have a dramatic effect on patient care and outcomes. A staggering proportion of medications worldwide are reported to be substandard or falsified. This article explores one country’s story of how medication gets to the bedside, describes how this process can go wrong, and outlines what providers can do to work toward the goal of equitable access to quality medications for all.

show abstract

“…The product had been dis tributed by a British distributor. Notably, this distributor was located at the same address and was apparently managed by the same family as a dis tributor company who had been reported to distribute substandard propo fol, an anaesthetic, to the government of Zambia (Mumphansha et al 2017). Through WHO, the British regulatory agency (MHRA) was in formed.…”

Section: Levomethorphan-containing Cough Syrups In Pakistan Andmentioning

confidence: 99%