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Safety of medicines with respect to drug counterfeiting in developing countries

Elmi, Ahmed 2013. Safety of medicines with respect to drug counterfeiting in developing countries. PhD Thesis, Cardiff University.
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Background: This thesis presents a study of the safety of medicines with respect to drug counterfeiting in developing countries (East Africa and the Middle East). Counterfeit medicines are also present in industrialised countries, but not on the same scale as in developing countries. The aim of the study was to establish the responsiveness of health care professionals at the practice level concerning the counterfeiting of medicinal products in developing countries focusing on six countries in the East African region and seven countries located in the Middle East. Method: The method of data acquisition used was by survey questionnaires issued in 13 developing countries (6 in East Africa and 7 in the Middle East). The questionnaires were delivered to the respondents either personally or by e-mail and the questionnaire, responses were returned by the same means. Respondents returned their questionnaire forms direct to the author either on the same day or later by e-mail. The data were analysed with regard to the specific questions. Results: The study findings suggested that the poorer the country, the higher the degree of counterfeiting. All the respondents (n: 2180) agreed that there was a fake or counterfeit medicine problem in their own country (71% of respondents in Africa and 63% of respondents in the Middle East considered this a major problem). Both branded and generic drugs were counterfeited and the extent of the problem and several other factors concerning counterfeited drugs differed significantly between industrialised and developing countries. The difference depended on drug regulation control and enforcement and also on the quality and the prices in the legal supply chain. In most industrialised countries like the USA, Japan or the members of the EU, the level v of drug counterfeiting is <1% of the total medicines market value. An exception is the former Soviet Union where up to 20% of the market is occupied by counterfeit drugs. In contrast, within regions of Africa, Asia and parts of Latin America, between 10-30% of the available medicines are fakes (WHO 2006) Conclusions: The study showed that healthcare workers were aware of the prevalence of counterfeit medicines and quite a number of them had encountered them in their supply role. There is an indication that the respondents tried to assure themselves of the quality of the drugs they purchased by using several methods. However, no rigorous effort was taken to confirm as well as report suspected counterfeit drugs to regulatory authorities. In the industrialised world, medicines regulatory authorities have developed strict standards and controls to ensure the safety and effectiveness of drugs. However, as this study has found, in less developed countries a lack of human and financial resources within the health sector as a whole restricted the activity of regulatory agencies, resulting in a sub-optimally regulated environment in which substandard drug production persisted without detection.

Item Type: Thesis (PhD)
Status: Unpublished
Schools: Pharmacy
Subjects: Q Science > Q Science (General)
R Medicine > R Medicine (General)
R Medicine > RM Therapeutics. Pharmacology
Uncontrolled Keywords: Safety; medicines; developing countries;
Date of First Compliant Deposit: 30 March 2016
Last Modified: 19 Mar 2016 23:26

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