Substandard and counterfeit medicines: a systematic review of the literature

Almuzaini, Tariq, Choonara, Imti and Sammons, Helen (2013) Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open, 3 (8). e002923. ISSN 2044-6055

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Objective: To explore the evidence available of poor quality

(counterfeit and substandard) medicines in the literature.

Design: Systematic review.

Data sources: Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013.

Eligibility criteria: Prevalence studies containing original data. WHO definitions (1992) used for

counterfeit and substandard medicines. Study appraisal and synthesis: Two reviewers independently scored study methodology against recommendations from the MEDQUARG Checklist. Studies were classified according to the World Bank classification of countries by income.

Data extraction: Data extracted: place of study; type

of drugs sampled; sample size; percentage of substandard/counterfeit medicines; formulations

included; origin of the drugs; chemical analysis and

stated issues of counterfeit/substandard medicines.

Results: 44 prevalence studies were identified, 15 had

good methodological quality. They were conducted in

25 different countries; the majority were in low-income

countries (11) and/or lower middle-income countries

(10). The median prevalence of substandard/counterfeit

medicines was 28.5% (range 11–48%). Only two studies differentiated between substandard and counterfeit medicines. Prevalence data were limited to antimicrobial drugs (all 15 studies). 13 studies involved antimalarials, 6 antibiotics and 2 other medications. The majority of studies (93%) contained samples with inadequate amounts of active ingredients. The prevalence of substandard/counterfeit antimicrobials was significantly higher when purchased from unlicensed outlets (p<0.000; 95% CI 0.21 to 0.32). No individual data about the prevalence in upper middle-income countries and high-income countries

were available.

Limitations: Studies with strong methodology were

few. The majority did not differentiate between

substandard and counterfeit medicines. Most studies

assessed only a single therapeutic class of


Conclusions: The prevalence of poor-quality

antimicrobial medicines is widespread throughout

Africa and Asia in lower income countries and lower

middle-income countries . The main problem identified

was inadequate amounts of the active ingredients.

Item Type: Article
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Medical Sciences and Graduate Entry Medicine
Identification Number:
Depositing User: Kirkland, Mrs Karen
Date Deposited: 09 May 2014 16:56
Last Modified: 04 May 2020 20:19

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