title: Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011).
abstract: OBJECTIVE
  To determine the extent of substandard and falsified medicines in the UK.
  
  
  METHODS
  A retrospective review of drug alerts and company-led recalls.
  
  
  METHODS
  The Medicines and Healthcare Products Regulatory Agency (MHRA) website search for drug alerts issued between 2001 and 2011.
  
  
  METHODS
  Drug alerts related to quality defect in medicinal products.
  
  
  METHODS
  Relevant data about defective medicines reported in drug alerts and company-led recalls, including description of the defect, type of formulation, year of the alert and category of the alert.
  
  
  RESULTS
  There were 280 substandard medicines of which 222 were recalled. The two most frequent problems were contamination (74 incidents) and issues related to packaging (98 incidents). Formulations for parenteral administration (117 incidents) were the formulation most frequently affected. There were 11 falsified medicines, as defined by the MHRA, reported over the 11-year period. The number of defective medicines reported by the MHRA increased 10-fold from 5 in 2001 to 50 in 2011.
  
  
  CONCLUSIONS
  Substandard medicines are a significant problem in the UK. It is uncertain whether the increasing number of reports relates to improved detection or an increase in the number of substandard medicines.
authors.affiliation: Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
authors.forename: Tariq
authors.initials: T
authors.lastname: Almuzaini
authors.forename: Helen
authors.initials: H
authors.lastname: Sammons
authors.forename: Imti
authors.initials: I
authors.lastname: Choonara
keywords: Defective; Falsified; Medicines; Substandard