Substandard and counterfeit medicines: a systematic review of the literature
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...
| Main Authors: | , , |
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| Format: | Article |
| Published: |
BMJ Publishing Group
2013
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| Online Access: | https://eprints.nottingham.ac.uk/2845/ |
| Summary: | 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. |
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