Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011)
Almuzaini, Tariq; Sammons, Helen; Choonara, Imti
Objective: To determine the extent of substandard
and falsified medicines in the UK.
Design: A retrospective review of drug alerts and
Setting: The Medicines and Healthcare Products
Regulatory Agency (MHRA) website search for drug
alerts issued between 2001 and 2011.
Eligibility criteria: Drug alerts related to quality
defect in medicinal products.
Main outcome measure: 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
Almuzaini, T., Sammons, H., & Choonara, I. (2013). Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011). BMJ Open, 3(7), doi:10.1136/bmjopen-2013-002924
|Journal Article Type||Article|
|Publication Date||Jul 24, 2013|
|Deposit Date||Apr 3, 2014|
|Publicly Available Date||Apr 3, 2014|
|Publisher||BMJ Publishing Group|
|Peer Reviewed||Peer Reviewed|
|Copyright Statement||Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0|
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0