Raffaella’s Literature Update
The following message is courtesy of Dr. Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium.
Ref (1) Dhakal N, Gyanwali P, Humagain B, BC R, Jha N, Sah P, et al. (2023) Assessment of quality of essential medicines in public health care facilities of Nepal: Findings of a nationwide study. PLOS Glob Public Health 3(5): e0001841.
Ref (2) Ocan M, Nakalembe L, Otike C, Omali D, Buzibye A, Nsobya S. Pharmacopeial quality of artemether-lumefantrine anti-malarial agents in Uganda. Malar J. 2023 May 26;22(1):165
This week, I would like to share two papers that address the issue of quality of medicines in two quite different contexts, and that can be interesting for all those who work in pharmaceutical systems or services, and/or who advocate for universal access to quality-assured medicines.
In the first paper, Dhakal and colleagues present the result of a study that assessed the quality of essential medicines available in 62 public health care facilities in 21 districts of Nepal. In short, the researchers found that only 13% of surveyed health facilities followed the medicine storage guidelines (with temperature and humidity levels often exceeding recommended limits). Out of 244 tested batches of generic essential medicines, 37 (ciprofloxacin hydrochloride eye/ear drop, Iron supplement tablets, Metformin Hydrochloric tablet, Metronidazole Tablets, Paracetamol Oral suspension, Paracetamol tablet and Povidone Iodine solution) were found to be substandard. The authors recommend “the urgent need for the Government of Nepal to prioritize ensuring the quality of essential medicines in the country”.
In the second paper, Ochan and colleagues present the results of a cross-sectional study conducted among randomly selected private drug outlets in Uganda, to assess the quality of artemether-lumefantrine (AL) containing products. Out of 74 samples, the overall prevalence of substandard quality was 18.9% (even if all had passed the visual inspection). The authors comment that substandard artemether–lumefantrine agents (the recommended first-line treatment for uncomplicated malaria) is common, and conclude that “there is need for continuous surveillance and monitoring of the quality of artemisinin-based anti-malarials across the country by the drug regulatory agency”.
Both studies seem to confirm that there is still an important need to strengthen the capacity of regulators along the medicines life cycle, from manufacturing to post-marketing surveillance, in order to prevent health harm to the users as well as the emergence of new resistances.