Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011)
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. Elig...
| Main Authors: | , , |
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| Format: | Article |
| Published: |
BMJ Publishing Group
2013
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| Online Access: | https://eprints.nottingham.ac.uk/2844/ |
| _version_ | 1848790890462576640 |
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| author | Almuzaini, Tariq Sammons, Helen Choonara, Imti |
| author_facet | Almuzaini, Tariq Sammons, Helen Choonara, Imti |
| author_sort | Almuzaini, Tariq |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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 |
| first_indexed | 2025-11-14T18:19:48Z |
| format | Article |
| id | nottingham-2844 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T18:19:48Z |
| publishDate | 2013 |
| publisher | BMJ Publishing Group |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-28442020-05-04T16:37:47Z https://eprints.nottingham.ac.uk/2844/ 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 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 BMJ Publishing Group 2013-07-24 Article PeerReviewed 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 http://bmjopen.bmj.com/content/3/7/e002924.full?rss=1 doi:10.1136/bmjopen-2013-002924 doi:10.1136/bmjopen-2013-002924 |
| spellingShingle | Almuzaini, Tariq Sammons, Helen Choonara, Imti Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011) |
| title | Substandard and falsified medicines in the UK: a
retrospective review of drug alerts (2001-2011) |
| title_full | Substandard and falsified medicines in the UK: a
retrospective review of drug alerts (2001-2011) |
| title_fullStr | Substandard and falsified medicines in the UK: a
retrospective review of drug alerts (2001-2011) |
| title_full_unstemmed | Substandard and falsified medicines in the UK: a
retrospective review of drug alerts (2001-2011) |
| title_short | Substandard and falsified medicines in the UK: a
retrospective review of drug alerts (2001-2011) |
| title_sort | substandard and falsified medicines in the uk: a
retrospective review of drug alerts (2001-2011) |
| url | https://eprints.nottingham.ac.uk/2844/ https://eprints.nottingham.ac.uk/2844/ https://eprints.nottingham.ac.uk/2844/ |