Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011)

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Almuzaini, Tariq, Sammons, Helen and Choonara, Imti (2013) Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011). BMJ Open, 3 (7). 10/1-10/10. ISSN 2044-6055

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Abstract

Objective: To determine the extent of substandard

and falsified medicines in the UK.

Design: A retrospective review of drug alerts and

company-led recalls.

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

Item Type: Article
RIS ID: https://nottingham-repository.worktribe.com/output/716268
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Medical Sciences and Graduate Entry Medicine
Identification Number: 10.1136/bmjopen-2013-002924
Depositing User: de Sousa, Mrs Shona
Date Deposited: 03 Apr 2014 13:32
Last Modified: 04 May 2020 16:37
URI: https://eprints.nottingham.ac.uk/id/eprint/2844

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