Substandard and counterfeit medicines: a systematic review
of the literature

Almuzaini, Tariq; Choonara, Imti; Sammons, Helen

Abstract

Objective: To explore the evidence available of poorquality
(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
antimicrobials.
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.

Citation

of the literature. BMJ Open, 3(8), Article e002923. https://doi.org/10.1136/bmjopen-2013-002923

• Journal Article Type: Article
• Acceptance Date: Jul 11, 2013
• Online Publication Date: Aug 17, 2013
• Publication Date: Aug 17, 2013
• Deposit Date: Apr 3, 2014
• Publicly Available Date: Apr 3, 2014
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 3
• Issue: 8
• Article Number: e002923
• DOI: https://doi.org/10.1136/bmjopen-2013-002923
• Public URL: https://nottingham-repository.worktribe.com/output/717036
• Publisher URL: http://bmjopen.bmj.com/content/3/8/e002923.abstract?sid=21fcbc5a-e488-4780-bad1-ab51cda17a33
• Contract Date: Apr 3, 2014