The Primacy of Public Health Considerations in Defining Poor Quality Medicines

Newton, Paul N.; Amin, Abdinasir A; Bird, Chris; Passmore, Phillip; Dukes, Graham; Tomson, Göran; Simons, Bright; Bate, Roger; Guérin, Philippe J.; White, Nicholas J.

doi:10.1371/journal.pmed.1001139

Cited by 93 publications

(101 citation statements)

References 7 publications

(17 reference statements)

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“…Chemical and packaging analysis is required to conclude if a medicine is substandard or counterfeit. This, however, is difficult and rarely reported 13. Therefore, the term substandard/counterfeit medicine is used in this review unless studies formally assessed packaging to differentiate medicines into these two different categories.…”

Section: Methodsmentioning

confidence: 99%

Substandard and counterfeit medicines: a systematic review of the literature

2013

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ObjectiveTo explore the evidence available of poor-quality (counterfeit and substandard) medicines in the literature.DesignSystematic review.Data sourcesDatabases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013.Eligibility criteriaPrevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines.Study appraisal and synthesisTwo 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 extractionData 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.Results44 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.LimitationsStudies 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.ConclusionsThe 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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Section: Methodsmentioning

confidence: 99%

Substandard and counterfeit medicines: a systematic review of the literature

2013

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“…Substandard TB drugs may also result in treatment failure and the development of resistance [9]. Linezolid, bedaquiline and delamanid are expensive and generics could further reduce cost and facilitate treatment of more patients.…”

Section: Antibiotic Stewardship For Xdr-tbmentioning

confidence: 99%

Antibiotic stewardship for drug resistant tuberculosis

Padayatchi

Mahomed

Loveday

et al. 2016

Expert Opinion on Pharmacotherapy

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“…Newton's definition, low quality drugs encompass falsified/counterfeit, substandard or degraded drugs [10]. This definition seems practical and adapted to the study in the present paper.…”

Section: Introductionmentioning

confidence: 99%

Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo

Tshilombo

Hamuli

Mbinze

et al. 2018

AJAC

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In order to combat the counterfeiting of drugs, adapted HPLC analytical USP methods were applied to evaluate the quality of the amoxicillin (with or without potassium clavulanate) powder for suspension sold in some Congolese markets. The adaptation has been done by modifying the column dimensions and adjusting the flow rate. According to the intended deployment of these methods in Democratic Republic of Congo (DRC), 3 factors (analyst, day and equipment) were involved in the validation step while applying the classic total error measurement approach with an accuracy profile as decision tool. Since adequate results were obtained in terms of selectivity, precision, trueness and accuracy (tolerance limits of life expectancy: −6.0% and 3.8%) for levels of interest concentration, the methods have been considered for routine use on several samples from different provenances and collected in 4 major DRC cities. Out of 278 samples collected, 200 were eligible for analysis from which 28% were found under standards with several figures: pH failure, out of specification for amoxicillin content, absence of potassium clavulanate, physical modifications of the powders. As evidenced by these findings, medicines How to cite this paper: Tshilombo, N

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The Primacy of Public Health Considerations in Defining Poor Quality Medicines

Abstract: Paul Newton and colleagues argue that public health, and not intellectual property or trade issues, should be the prime consideration in defining and combating counterfeit medicines, and that the World Health Organization (WHO) should take a more prominent role.

Cited by 93 publications

References 7 publications

Substandard and counterfeit medicines: a systematic review of the literature

Substandard and counterfeit medicines: a systematic review of the literature

Antibiotic stewardship for drug resistant tuberculosis

Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo

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