title: 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.
  
  
  METHODS
  Systematic review.
  
  
  METHODS
  Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013.
  
  
  METHODS
  Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors: Tariq
authors: T
authors: Almuzaini
authors: Imti
authors: I
authors: Choonara
authors: Helen
authors: H
authors: Sammons
keywords: anti-infective; counterfeit drug; drug counterfeiting; fake drug; substandard drug
references: Trends Pharmacol Sci. 2010 Mar;31(3):99-101
references: 20117849
references: Med Trop (Mars). 2006 Dec;66(6):573-6
references: 17286024
references: Trop Med Int Health. 2004 Dec;9(12):1241-6
references: 15598255
references: Lancet. 2001 Jun 16;357(9272):1933-6
references: 11425415
references: Trop Med Int Health. 2008 Aug;13(8):1062-72
references: 18631318
references: PLoS One. 2008;3(10):e3403
references: 18923672
references: PLoS Med. 2011 Dec;8(12):e1001139
references: 22162953
references: Afr Health Sci. 2003 Apr;3(1):2-6
references: 12789081
references: J Pharm Sci. 2011 Nov;100(11):4571-9
references: 21698604
references: Trends Parasitol. 2008 Mar;24(3):127-34
references: 18262470
references: Trans R Soc Trop Med Hyg. 2006 Nov;100(11):1019-24
references: 16765399
references: Malar J. 2009 Feb 10;8:22
references: 19208221
references: Res Social Adm Pharm. 2009 Mar;5(1):4-16
references: 19285285
references: PLoS Med. 2009 Jul 21;6(7):e1000097
references: 19621072
references: Trop Med Int Health. 1997 Sep;2(9):839-45
references: 9315042
references: Am J Law Med. 2006;32(2-3):279-323
references: 16927613
references: Pharm World Sci. 2004 Dec;26(6):333-8
references: 15683103
references: BMJ. 2012 Nov 14;345:e7518
references: 23152570
references: BMJ. 2012 Nov 13;345:e7381
references: 23149211
references: PLoS Med. 2009 Mar 24;6(3):e52
references: 19320538
references: Am J Trop Med Hyg. 2004 Mar;70(3):245-50
references: 15031511
references: Antimicrob Agents Chemother. 2003 Sep;47(9):2929-32
references: 12936996
references: BMC Infect Dis. 2010 Jul 09;10:203
references: 20618975