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J Pharm Sci. 2018 Oct;107(10):2720-2730. doi: 10.1016/j.xphs.2018.06.012. Epub 2018 Jun 21.

Drug Quality in South Africa: A Field Test.

Author information

1
Goethe University Frankfurt am Main, Institute of Pharmaceutical Technology, Frankfurt, Germany.
2
Tshwane University of Technology, Department of Pharmaceutical Sciences, Pretoria, South Africa.
3
Goethe University Frankfurt am Main, Institute of Pharmaceutical Technology, Frankfurt, Germany. Electronic address: dressman@em.uni-frankfurt.de.

Abstract

To assess drug quality and pharmaceutical care in South Africa, "mystery" (i.e., anonymous) customers collected 316 samples from July to September 2016. Solid dosage forms containing amoxicillin alone or in combination with clavulanic acid as well as analgesics containing paracetamol alone or in combination with other drugs were sampled in a randomized fashion from the formal market (pharmacies) and by convenient sampling from the informal market. Visual inspection, uniformity of dosage units, and dissolution testing were performed to evaluate adherence to pharmacopoeial quality standards and to identify counterfeit, degraded, or substandard drugs. Although no counterfeited products were identified, only 55.4% (173/312) of samples were able to fulfill all pharmacopeial requirements for quality. Most of the 139 samples that failed were unable to pass the visual inspection due to inappropriate labeling and packaging. In addition, several substandard products were identified: 17 (5.4%) samples failed dissolution testing and 15 (4.8%) failed the content uniformity test. To improve drug quality and the quality of pharmaceutical care, better education of pharmaceutical professionals and monitoring of the pharmaceutical supply chain in South Africa are needed. Further field studies are necessary to evaluate risks and quality issues for other drug classes and distribution channels.

KEYWORDS:

HPLC; South Africa; counterfeit; degraded; dissolution test; falsified; field test; medicine quality; substandard

PMID:
29936204
DOI:
10.1016/j.xphs.2018.06.012
[Indexed for MEDLINE]

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