Open Access Research article

Quality of generic medicines in South Africa: Perceptions versus Reality – A qualitative study

Aarti Patel12*, Robin Gauld3, Pauline Norris4 and Thomas Rades4

Author Affiliations

1 Southern African Development Community (SADC), PO Box 95, Gaborone, Botswana

2 Hera: right to health & development, Reet, Belgium

3 Department of Preventive and Social Medicine, University of Otago Medical School, PO Box 913, Dunedin 9054, New Zealand

4 New Zealand's National School of Pharmacy, University of Otago, PO Box 56, Dunedin 9054, New Zealand

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BMC Health Services Research 2012, 12:297  doi:10.1186/1472-6963-12-297

Published: 3 September 2012

Abstract

Background

Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers’ and healthcare providers’ perceptions of quality of generics to the actual quality of selected products.

Methods

The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73) and random sampling used to recruit healthcare providers from public and private sectors (n = 15). Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15) with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47), amoxicillin capsules (n = 45) and hydrochlorothiazide tablets (n = 43) were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy) tests using prescribed methods from the British (2005) and United States Pharmacopeias (2006).

Results

Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers’ names and consumers’ ability to pay. All formulations passed the in vitro tests for quality.

Conclusions

This study showed clear differences between perceptions of quality and actual quality of medicines suggesting deficiencies in public engagement by government regarding the implementation of generic medicines policy. Implementation of generic medicines policy requires the involvement of consumers and healthcare providers to specifically address their information gaps and needs.