The Pharmaceutical Journal
Vol 278 No 7456 p705
16 June 2007

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• White Paper (2)
• Liberal professions
• Pseudoephedrine
• Substance misuse (2)
• MDS (2)
• Counterfeit medicines
• NHS
• Women in pharmacy
• Technicians (2)
• Retention fees
• The Journal (2)

Letters to the Editor

Counterfeit medicines

Was it necessary to issue a class 1 recall?

From Mr R. D. Miles, MRPharmS

The recall of counterfeit bicalutamide 50mg (PJ, 9 June, p668) meant that a well-practised procedure had to be initiated in every pharmacy. Records had to be checked, stock examined and wards and patients contacted. This is all done efficiently but is disruptive to a busy pharmacy. However, had the fax come through a few hours later the consequences would have been far more serious: pharmacists called out of bed to cascade the notice, ward activity disrupted to check stock, patients frightened. And for what purpose?

A counterfeit product containing 75 per cent active ingredient had entered the supply chain, but did it pose an immediate threat to life such as the consequences of an unsterile injection, a tablet contaminated by penicillin, or an inactive resuscitation drug? I think not. There was no statement that the batch did contain harmful contaminants. So why the status of class 1 — “action immediately including out of hours”?

The Medicines and Healthcare products Regulatory Agency had, rightly, undertaken some laboratory work and initial investigations. It also provided an excellent question-and-answer sheet to help us deal with the situation. This must have taken time, so why the extreme urgency with the alert?

A cynic might conclude that any loss of confidence in parallel imported products can only benefit the large pharmaceutical companies, which pay most in fees to the MHRA.

Counterfeit products are a threat to patient care and the MHRA, as a custodian of public safety, is right to take a strong stand against them, but is a class 1 recall justified when life is not threatened? I have my doubts.

Roger Miles
Regional Specialist Procurement Pharmacist (NW)
Royal Bolton Hospital

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