Post-market quality monitoring of medicines in Christian Health Association of Ghana health institutions.

Abstract

Objective: To determine the quality of selected frequently used medicines in CHAG facilities in a LMIC country setting.

Design: Quality testing of collected samples of generic medicines in health facility pharmacies.

Setting and participating facilities: The study evaluated the quality of 639 representative samples of 14 generic products using a TruScan Raman (RM) analyser and Minilab in 62 CHAG facilities across five administrative regions of Ghana.

Results: Out of 639 samples of various branded generics of the 14 product samples tested in the field using the Truscan RM analyser, 210 products (32.8%) failed the test. All samples from ceftriaxone injection 1 g, ciprofloxacin 500 mg, metronidazole 200 mg, and metformin 500 mg passed the Truscan RM test. High passes were also recorded for paracetamol 500 mg (96.6%), artemether/lumefantrine 80/480 mg (95.8%), and oral rehydration salts (94%). Conversely, all the forty-two (42) samples obtained and tested for flucloxacillin 250 mg failed the Truscan analyser test. Relatively high failures were also recorded for lisinopril 10 mg (90.5%) and albendazole 400 mg (89.8%). All samples submitted for secondary screening using Minilab analysis showed the presence of their respective active pharmaceutical ingredients as indicated on their respective labels.

Conclusion: The Truscan/Minilab combination is reasonably affordable and efficient for undertaking post-market monitoring of the quality of essential medicines in Ghanaian health facilities. For future application of Truscan, a check of standard spectra is essential, and the choice of tracer medicines should include those with limited fluorescence materials in formulations and a relatively high percentage of active ingredients.

Funding: This study was funded by Pharmaccess Foundation Ghana and the Netherlands.