The Pharmaceutical Journal
Vol 278 No 7457 p733
23 June 2007

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• Supervision
• Counterfeit medicines
• Citric acid
• White Paper (2)
• The Council
• MDSs
• Pfizer (2)

Letters to the Editor

Counterfeit medicines

Was it necessary to issue a class 1 recall?

From Mr I. Holloway, MRPharmS

In response to the letter from Roger Miles (PJ, 16 June, p705) I would like to comment on the actions taken. The recent series of drug alerts for counterfeits have clearly demonstrated that the risks involved are higher than those normally seen in defective bona fide medicines. We cannot be sure that any counterfeit batches are homogeneous and we had some specific evidence of some intra-batch variation within the recent counterfeit batches.

We provided an initial assay outcome for the bicalutamide tablets which did give the result of about 75 per cent of the stated active ingredient. However, the samples tested may not have been representative of the entire batch. Counterfeits often contain unknown contaminants which cannot be quickly evaluated by the established validated test methods. Time is paramount in the issue of drug alerts and we did not judge it acceptable to wait for a full forensic examination in any of the recent cases. The action taken was endorsed by medical advisers from both the Medicines and Healthcare products Regulatory Agency and AstraZeneca.

With counterfeit products there is no information on production or test methods (if any are applied) and degradant and cross-contamination risks are expected to be much higher than in validated and approved products. We therefore maintain that counterfeits should be considered as a serious health risk until enough evidence is available to downgrade the threat.

We are grateful for the assistance provided by hospitals, community pharmacists, physicians and wholesalers in the recent series of drug alerts in safeguarding public health.

Ian Holloway
Manager
MHRA Defective Medicines Report Centre

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