2025/01/01 by J S Namugambe · 1 voice
Economics, Econometrics and Finance · Health Professions · Medicine · #Pharmaceutical Economics and Policy #Pharmaceutical Quality and Counterfeiting #Safe Handling of Antineoplastic Drugs
paper · pdf · doi:10.17037/pubs.04678077
openalex publication_date 2025/01/01 · openalex created_date 2026/01/21 · openalex updated_date 2026/07/01
Access to quality-assured medicines is crucial for combating malaria, yet about 19% of antimalarials in low and middle-income countries are reported to be of poor quality, posing serious health risks and economic losses. Malaria is highly endemic in Uganda, accounting for 10.9% of all deaths in the country in 2021. Private retail medicine outlets are often the first point of contact for patients and a major source of medicines in Uganda. Despite this, there is a lack of data on the prevalence of substandard or falsified (SF) antimalarials and the factors affecting medicine quality in these outlets. This research aimed to assess the prevalence of SF antimalarials and associated factors in private medicines outlets in Bugisu region, Eastern Uganda. The objectives were addressed through a combination of methods, that involved an outlet mapping census, structured questionnaires surveys to assess outlet characteristics and practices, and the purchasing samples of artemether/lumefantrine tablets (AL), dihydroartemisinin/piperaquine (DHA/PIP) tablets and injectable artesunate using both mystery client and overt approaches. Purchased antimalarials were analysed for stated active pharmaceutical ingredients (APIs) content, using High Performance Liquid Chromatography. Each sample was then classified according to the World Health Organization International Pharmacopoeia (11th Edition) tolerance limits as being acceptable quality, substandard or falsified The findings indicate that drug shops were the most prevalent type of private medicine outlets in both the urban and rural areas of Bugisu region. Urban areas had a higher number of licensed outlets and all the pharmacies. Overall, substandard antimalarials were identified in 35.8% of outlets surveyed. There were gaps in compliance to good medicine storage practices especially temperature monitoring and record keeping. Laboratory analysis revealed that all samples contained the API indicated on the packaging, with no falsified medicines detected. However, 20% of AL, 66% of DHA/PIP and 50% of injectable artesunate were substandard, mainly due to low API content. WHO prequalification status was significantly associated with quality for DHA/PIP and injectable artesunate samples. There were no significant differences in quality between different outlet types (drug shop, clinic or pharmacy), license status, location (urban or rural), or staff characteristics and practices and conditions. These findings underline the need for increased surveillance of antimalarial quality, with a particular focus on injectable artesunate, to mitigate risks such as impaired neurological function, increased mortality and economic burden associated with inadequate treatment of severe malaria.