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)

رابط إلى البحث:

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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.