Dataset Information

Substandard and counterfeit medicines: a systematic review of the literature.

ABSTRACT:

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.

SUBMITTER: Almuzaini T

PROVIDER: S-EPMC3752049 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Substandard and counterfeit medicines: a systematic review of the literature.

Almuzaini Tariq T Choonara Imti I Sammons Helen H

BMJ open 20130817 8

<h4>Objective</h4>To explore the evidence available of poor-quality (counterfeit and substandard) medicines in the literature.<h4>Design</h4>Systematic review.<h4>Data sources</h4>Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013.<h4>Eligibility criteria</h4>Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines.<h4>Study appraisal and synthesis</h4 ...[more]

PMID: 23955188

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Project description:ImportanceSubstandard and falsified medicines burden health systems by diverting resources to ineffective or harmful therapies, causing medical complications and prolonging illnesses. However, the prevalence and economic impact of poor-quality medicines is unclear.ObjectiveTo conduct a systematic review and meta-analysis to assess the prevalence and estimated economic burden of substandard and falsified essential medicines in low- and middle-income countries.Data sourcesFive databases (PubMed, EconLit, Global Health, Embase, and Scopus) were searched from inception until November 3, 2017.Study selectionPublications were assessed to determine whether they examined medicine quality and the prevalence and/or economic burden of substandard and falsified medicines in low- and middle-income countries. Studies with a sample size of 50 or more were included in the meta-analysis.Data extraction and synthesisThe study is registered in PROSPERO and reported via the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Study quality was assessed using an adapted Medicine Quality Assessment Reporting Guidelines scoring metric. Multiple reviewers conducted the data extraction and quality assessment independently.Main outcomes and measuresPrevalence and/or estimated economic impact of substandard and falsified medicines.ResultsTwo hundred sixty-five studies that estimated the prevalence of poor-quality essential medicines in low- and middle-income countries were identified. Among 96 studies that tested 50 samples or more (67 839 total drug samples), overall prevalence of poor-quality medicines was 13.6% (95% CI, 11.0%-16.3%), with regional prevalence of 18.7% in Africa (95% CI, 12.9%-24.5%) and 13.7% in Asia (95% CI, 8.2%-19.1%). Of studies included in the meta-analysis, 19.1% (95% CI, 15.0%-23.3%) of antimalarials and 12.4% (95% CI, 7.1%-17.7%) of antibiotics were substandard or falsified. Eight approximations of the economic impact, focused primarily on market size, with poor or undisclosed methods in estimation were identified, ranging from $10 billion to $200 billion.Conclusions and relevancePoor-quality essential medicines are a substantial and understudied problem. Methodological standards for prevalence and rigorous economic studies estimating the burden beyond market size are needed to accurately assess the scope of the issue and inform efforts to address it. Global collaborative efforts are needed to improve supply-chain management, surveillance, and regulatory capacity in low- and middle-income countries to reduce the threat of poor-quality medicines.Trial registrationPROSPERO Identifier: CRD42017080266.

Project description:IntroductionOver the years, counterfeit pharmaceuticals have posed immense concerns for global health and patient safety. This menace encompasses various classes of medications. Given the criticality of pharmacists' interventions in drug distribution and supply, this study aimed at exploring their role in the prevention and control of counterfeit pharmaceutical products in Nigeria.MethodsA cross-sectional study was undertaken, using questionnaires to collect data from pharmacists across various sectors of pharmacy practice in Nigeria. Face and content validity was undertaken on the study tool prior to data collection. Ethical approval was obtained from the National Institute for Pharmaceutical Research and Development Health Research Ethics Committee, and confidentiality was strictly maintained during data collection process. Data were analyzed using Statistical Package for Social Sciences. Descriptive statistical analysis was undertaken and chi square was used to determine association between socio-demographic characteristics and variables.ResultsThe responses comprised 205 (52.6%) female and 185 (47.4%) male participants. Almost all the participants (98.4%) agreed that strict enforcement of drug laws can contribute to adequate control of counterfeit medicines in Nigeria, and majority of the study sample (64.7%) indicated that the poor implementation of these laws was a major factor influencing the preponderance of counterfeit medicines in the country. Two-thirds (63.5%) of the participants supported the need for pharmacists to provide adequate education to patients on strategies to identify counterfeit medicines, and a similar proportion (68.0%) were of the opinion that it was the responsibility of pharmacists to ensure that drugs are purchased from credible sources.ConclusionFindings from this study, in addition to confirming pharmacists' instrumentality in the fight against counterfeit medicines, identified certain context specific factors that can strengthen the regulation, policy and the entire healthcare system. Government and relevant stakeholders can therefore begin to articulate strategic reforms for contextual policy intervention that address medicines' counterfeiting, whilst prioritising pharmacists' role in other critical areas in the healthcare system.

Dataset Information

Substandard and counterfeit medicines: a systematic review of the literature.

Objective

Design

Data sources

Eligibility criteria

Study appraisal and synthesis

Data extraction

Results

Limitations

Conclusions

Publications

Substandard and counterfeit medicines: a systematic review of the literature.

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