مجال التميز

تميز دراسي وبحثي

البحوث المنشورة

البحث (1):

عنوان البحث:

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

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تاريخ النشر:

24 July 2013

موجز عن البحث:

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.

البحث (2):

عنوان البحث:

Substandard and counterfeit medicines: a systematic review of the literature

رابط إلى البحث:

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تاريخ النشر:

17 August 2013

موجز عن البحث:

Objective To explore the evidence available of poor-quality (counterfeit and substandard) medicines in the literature.

Design Systematic review.

Data sources Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013.

Eligibility criteria Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines.

Study appraisal and synthesis Two reviewers independently scored study methodology against recommendations from the MEDQUARG Checklist. Studies were classified according to the World Bank classification of countries by income.

Data extraction Data extracted: place of study; type of drugs sampled; sample size; percentage of substandard/counterfeit medicines; formulations included; origin of the drugs; chemical analysis and stated issues of counterfeit/substandard medicines.

Results 44 prevalence studies were identified, 15 had good methodological quality. They were conducted in 25 different countries; the majority were in low-income countries (11) and/or lower middle-income countries (10). The median prevalence of substandard/counterfeit medicines was 28.5% (range 11–48%). Only two studies differentiated between substandard and counterfeit medicines. Prevalence data were limited to antimicrobial drugs (all 15 studies). 13 studies involved antimalarials, 6 antibiotics and 2 other medications. The majority of studies (93%) contained samples with inadequate amounts of active ingredients. The prevalence of substandard/counterfeit antimicrobials was significantly higher when purchased from unlicensed outlets (p<0.000; 95% CI 0.21 to 0.32). No individual data about the prevalence in upper middle-income countries and high-income countries were available.

Limitations Studies with strong methodology were few. The majority did not differentiate between substandard and counterfeit medicines. Most studies assessed only a single therapeutic class of antimicrobials.

Conclusions The prevalence of poor-quality antimicrobial medicines is widespread throughout Africa and Asia in lower income countries and lower middle-income countries. The main problem identified was inadequate amounts of the active ingredients.

البحث (3):

عنوان البحث:

Quality of medicines in Canada: a retrospective review of risk communication documents (2005–2013)

رابط إلى البحث:

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تاريخ النشر:

31 Oct 2014

موجز عن البحث:

Objective To explore the quality and safety of medicines in Canada.

Design A retrospective review of drug recalls and risk communication documents conveying issues relating to defective (ie, substandard and falsified) medicines.

Setting The Health Canada website search for drug recalls and risk communication documents issued between 2005 and 2013.

Eligibility criteria Drug recalls and risk communication documents related to quality defect in medicinal products.

Main outcome measure Relevant data about defective medicines reported in drug recalls and risk communication documents, including description of the defect, type of formulation, year of the recall and category of the recall or the document.

Results There were 653 defective medicines of which 649 were substandard. The number of defective medicines reported by Health Canada increased from 42 in 2005 to 143 in 2013. The two most frequently reported types of defects were stability (205 incidents) and contamination issues (139 incidents). Some of these defects were found to be more prominent and repetitive over other types within some manufacturers. Tablet formulation (251 incidents) was the formulation most frequently compromised. No significant

differences were observed between the manufacturers and distributors in the number of substandard medicines reported under each defect type. There were only four falsified medicines reported over the 9-year period.

Conclusions Substandard medicines are a problem in Canada and have resulted in an increasing number of recalled medicines. Most of the failures were related to stability issues, raising the need to investigate the root causes and for stringent preventative measures to be implemented by manufacturers.

المؤتمرات العلمية:

المؤتمر (1):

عنوان المؤتمر:

The 14^th ESDPPP Congress

تاريخ الإنعقاد:

04 Jun 2013

مكان الإنعقاد:

Salzburg, Austria

طبيعة المشاركة:

Poster presentation

عنوان المشاركة:

Counterfeit and substandard medicines in the UK: A retrospective review of drug alerts (2001–2011)

ملخص المشاركة:

Background: To determine the extent of counterfeit and substandard medicines in the UK.

Materials and Methods: A search for drug alerts and company-led recalls relating to defective medicinal products through the website of the Medicines and Healthcare Products Regulatory Agency (MHRA) between 2001 and 2011.

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 counterfeit medicines reported over the 11 year period. The number of defective medicines reported by the MHRA increased tenfold from five in 2001 to 50 in 2011.

Conclusion: 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.           

المؤتمر (2):

عنوان المؤتمر:

The 6th Saudi Scientific International Conference

تاريخ الإنعقاد:

11 Oct 2012

مكان الإنعقاد:

Brunel, UK

طبيعة المشاركة:

Poster presentation

عنوان المشاركة:

Generic and innovator medicines: Which are more likely to be substandard in the UK?

ملخص المشاركة:

Background: Despite the fact that there is no evidence available in the literature to support the superiority of innovator over generic drugs, the notion that innovators are better than generics in terms of quality and efficacy exists. Therefore, we wished to examine whether substandard drugs in the UK are predominantly generic medicines made by non-innovator manufacturers.

Materials and Methods: Substandard medicines recalled by the Medicines and Healthcare Regulatory Agency (MHRA) from 2001 to 2011 and their corresponding manufacturers were extracted from the MHRA website. Substandard medicines were classified as either generic or innovator drugs, using the US Food and Drug Administration’s search engine of approved drugs. This website classifies medicines as generic or innovator during their registration. (ADRs), underwent multidisciplinary review to assess causality.

Results: The review identified 89 manufacturers holding marketing authorisation for 280 substandard medicines. A total of 126 incidents of substandard medicines were identified as innovator medicines, whereas 124 were identified as generic medicines. 30 medicines were not classified as either generic or an innovator medicine, as the information required was not available. The number of substandard medicines recalled due to contamination issues was significantly higher among innovator than among generic medicines (P < 0.000). No significant differences were observed between innovator and generic medicines in other types of quality defects. Conclusion: Substandard medicines recalled in the UK were made by both generic and innovator manufacturers. The thought that substandard medicines are predominantly produced by non-innovator manufacturers is therefore incorrect. The study has shown in the UK recalls that the contamination of medicinal products is a pronounced problem with innovator manufacturers.