Substandard and counterfeit medicines: a systematic review of the literature
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 20...
| Main Authors: | , , |
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| Format: | Article |
| Published: |
BMJ Publishing Group Ltd
2013
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| Online Access: | https://eprints.nottingham.ac.uk/3142/ |
| _version_ | 1848790962258575360 |
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| author | Almuzaini, Tariq Choonara, Imti Sammons, Helen |
| author_facet | Almuzaini, Tariq Choonara, Imti Sammons, Helen |
| author_sort | Almuzaini, Tariq |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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
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. |
| first_indexed | 2025-11-14T18:20:57Z |
| format | Article |
| id | nottingham-3142 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T18:20:57Z |
| publishDate | 2013 |
| publisher | BMJ Publishing Group Ltd |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-31422020-05-04T20:19:03Z https://eprints.nottingham.ac.uk/3142/ Substandard and counterfeit medicines: a systematic review of the literature Almuzaini, Tariq Choonara, Imti Sammons, Helen 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 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. BMJ Publishing Group Ltd 2013-07 Article PeerReviewed 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 http://bmjopen.bmj.com/content/3/8/e002923 doi:10.1136/bmjopen-2013-002923 doi:10.1136/bmjopen-2013-002923 |
| spellingShingle | Almuzaini, Tariq Choonara, Imti Sammons, Helen Substandard and counterfeit medicines: a systematic review of the literature |
| title | Substandard and counterfeit medicines: a systematic review of the literature |
| title_full | Substandard and counterfeit medicines: a systematic review of the literature |
| title_fullStr | Substandard and counterfeit medicines: a systematic review of the literature |
| title_full_unstemmed | Substandard and counterfeit medicines: a systematic review of the literature |
| title_short | Substandard and counterfeit medicines: a systematic review of the literature |
| title_sort | substandard and counterfeit medicines: a systematic review of the literature |
| url | https://eprints.nottingham.ac.uk/3142/ https://eprints.nottingham.ac.uk/3142/ https://eprints.nottingham.ac.uk/3142/ |