- Todos > Quality and Safety: Medicines > Counterfeit Medicines
- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > drug quality assurance
- Palabras clave > Good Practices for Pharmaceutical Quality Control Laboratories (GPCL)
- Palabras clave > medicines quality assurance assessment
- Palabras clave > National pharmaceutical quality control laboratories
- Palabras clave > quality control - lot testing
- Palabras clave > quality of medicines
- Palabras clave > quality tests - medicines
- Palabras clave > samples - preparation, dispatch, and receipt
- Palabras clave > sampling and testing - medicines
- Palabras clave > testing - analysis of medicines and active pharmaceutical ingredients
(2014; 27 pages)
The proliferation of substandard medicines globally has become a public health concern. The scenario is even worse in sub Saharan African countries which have weak systems of governance and regulation. Despite all the strategies implemented by the Uganda Ministry of Health, anecdotal evidence shows that counterfeit and substandard medicines are still prevalent in the Ugandan market. Given the high prevalence of infectious diseases in the Ugandan population, the dealers in this business target antimicrobial medicines and distribute them to remote and peripheral areas of the country. Because of the complexity of assuring quality in resource limited settings, it has been advocated that drug regulatory authority activities are augmented by screening drug quality programs run in such a manner as to collect accurate information that better represents the quality of medicines made available to the consumers. Therefore, this drug quality screening project was conducted as an innovation where the Drug Regulatory Authority cooperates with other stakeholders as an additional dimension to drug quality assurance in a country such as Uganda with limited capacity.
It was a field based project employing a cross sectional design. Medicine samples of co-trimoxazole 480mg and 960mg tablets, ciprofloxacin 500mg tablets, amoxicillin 250mg or 500mg capsules and artemether/lumefantrine 20/120mg tablets were collected from a stratified random sample of drug outlets in Mbarara, Arua and Iganga/Mayuge districts. The screening of drug quality was conducted in the Pharmaceutical Chemistry Laboratory at Pharmacy Department in Makerere University using GPHF Minilabs.
Samples for screening drug quality were picked from a total of twenty nine (29) drug outlets from three regions of Uganda. Each region contributed almost an equal number of outlets to the total sampled units with the lowest being South West with eight (8) drug outlet and the highest being West Nile with eleven (11) drug outlets.
All categories of drug outlets including wholesale pharmacies, retail pharmacies, drug shops, clinics, public health facilities and informal drug outlets were represented in the sampled drug outlets.