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

## TL;DR

This study assessed the quality of commonly used medicines in Ghanaian health facilities and found that about a third failed quality tests, highlighting the need for better post-market monitoring.

## Contribution

The study demonstrates the effectiveness of using Truscan Raman and Minilab for affordable post-market medicine quality monitoring in low-resource settings.

## Key findings

- 32.8% of the 639 tested medicine samples failed the Truscan Raman quality test.
- Flucloxacillin 250 mg had 100% failure, while ceftriaxone, ciprofloxacin, and metronidazole passed completely.
- The Truscan/Minilab combination proved efficient and affordable for quality monitoring in Ghanaian health facilities.

## Abstract

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

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

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.

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.

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.

This study was funded by Pharmaccess Foundation Ghana and the Netherlands