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.

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 in

SUBMITTER: Almuzaini T 

PROVIDER: S-EPMC3731779 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature