Annual report 2011 on laboratory control activities

16 May 2013

The medical authorities in Europe cooperate in a network called the Official Medicines Control Laboratories (OMCL). The Danish Medicines Agency has published an annual report for 2011 that describes the activities of the Agency to the OMCL network.

Annual report 2011 of the Danish Medicines Agency's laboratory control activities

European laboratory cooperation in OMCL

The purpose of OMCL is to exchange knowledge and experience and to promote the elaboration of new common standards within the area of laboratory control of medicinal products. Follow this link to read more about the European laboratory cooperation.

Among the topics covered in the report are:

Testing of nationally authorised medicinal products

In 2011, the laboratory tested 461 nationally authorised medicinal products. 24 of these tests resulted in the withdrawal of products from the Danish market due to incorrect labelling. A large share of the tests (61 %) caused us to discuss matters concerning labelling, SOPs as well as specifications and stability issues with the manufacturer.

Adverse incidents at hospitals

In 2011, the Danish Medicines Agency screened approx. 4000 reports on adverse incidents that had been reported by hospitals to the Danish Patient Safety Database. 32 of these reports resulted in cases on labelling and packaging material or on the quality of the medicinal product.

Control of the availability of package leaflets at www.indlaegsseddel.dk

It should be easy for patients to have access to the latest version of a package leaflet of a medicine. The Danish Medicines Agency has developed a web-portal for package leaflets to accommodate this need. It is mandatory for marketing authorisation holders to upload package leaflets (Danish: indlægsseddel) to the portal on www.indlaegsseddel.dk. In 2011, we checked whether the companies had conformed with this requirement. For the approximately 5300 medicinal products we checked if the package leaflets were available, readable and carried a revision date. 8 % (431) package leaflets turned out to be unsatisfactory, which was corrected in 2011.

Illegal products and counterfeits

The Danish Medicines Agency maintained focus on illegal products and counterfeits in 2011. We tested 88 products.

  • 36 of 42 products contained weight-loss compounds,
  • 16 of 24 products contained potency-enhancing compounds,
  • 17 of 18 products contained nicotine,
  • 3 of 4 products contained glucocorticoids.

Illegal online sale of medicines and healthcare products may pose a serious risk to the health of consumers. The products may contain active pharmaceutical ingredients in varying quantities, quality and composition, with no guarantee of their safety and effect.

Package leaflets of antidepressants (SSRIs)

Out of 26 randomly selected products, we found that 21 did not contain a warning regarding pregnancy and breast-feeding. 11 companies were reported to the police, and 17 products were withdrawn.

Development of test methods

We work with the detection of extraneous agents in veterinary vaccines by means of real-time PCR. And we also work with cell therapy products.

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