The Pharmaceutical Journal
Vol 273 No 7316 p361
11 September 2004

Society summary

Advice on counterfeit medicines

Following the recall of Cialis bearing certain lot numbers (PJ, 28 August, p277) the Royal Pharmaceutical Society issued advice to pharmacists through its website. Further advice followed the recall of Reductil bearing a particular batch number (see p335). For the benefit of pharmacists without easy access to the internet, The Journal has combined the two documents into the following guidance.

How can the counterfeit material be identified? The Medicines and Healthcare products Regulatory Agency has identified Cialis lot numbers A031410 (expiry date 6/2006) and A011410 (expiry date not known) and Reductil batch number 65542 (expiry date 01/2007). They have been confirmed as counterfeit.

Authentic Reductil produced by Abbott Laboratories Ltd in the UK has a numeric batch number with a one-letter alphabetic suffix (eg, 141998D). Please inform the MHRA (tel 020 7084 2000) immediately if other material with just numeric numbers is identified.

What should pharmacists do if they identify a counterfeit lot/batch number in their stock? If pharmacists discover any of the counterfeit material in their stock, or if they believe that they may have supplied counterfeit Cialis or Reductil to patients, they should attempt to contact those patients. The patients should be informed of the potential problem with the product and advised to check whether they have any of a counterfeit batch.

Pharmacists should also contact Lilly ICOS Ltd (Cialis) and/or Abbott Laboratories Ltd (Reductil), which are co-ordinating the recovery of counterfeit material on behalf of the MRHA. Contact details are: Customer Services Leader, Eli Lilly & Co Ltd, Lilly House, Preistley Road, Basingstoke RG24 9NL (tel 0800 0853847); Customer Services, Abbott Laboratories Ltd, Queenborough ME11 5EL (tel 0800 018 1950).

What should pharmacists do if patients return counterfeit material to them? In the first instance the pharmacist should satisfy himself that he was the original supplier, eg, by referring to the original prescription, if available, or to the patient’s medication record. Having done so, the pharmacist should supply the patient with the correct medicines. The pharmacist should then contact Lilly or Abbott (see above) to arrange the return of the counterfeit medicine.

What if the pharmacist was not the original supplier? If the pharmacist was not the original supplier, he should refer the patient back to the original supplier. If the patient does not want to return to the original supplier, the pharmacist should accept the counterfeit material and refer the patient to his or her GP to obtain another prescription.

The pharmacist should then contact Lilly or Abbott, as above.

How will pharmacists be reimbursed for any counterfeit stock? Pharmacists should contact the original wholesaler to discuss reimbursement.

Are there any risks associated with the counterfeit material? The MHRA has confirmed that initial tests do not indicate any immediate safety problems with the counterfeit material but patients are advised not to take any of these tablets. In the case of Cialis, a patient who has already taken some of the tablets can be advised that the most likely side effects are: if the product is low in strength, it may not work; if the product is high in strength, it may give an abnormally prolonged and uncomfortable erection, in which case the patient should contact his GP.

What should pharmacists do if they have concerns about other counterfeit medicines? Any pharmacist who has concerns about the authenticity of any other medicines that they hold in stock is advised to contact either the Society’s local inspector or the MRHA for guidance and advice. Contact details for Society inspectors can be found on the Society website (www.rpsgb.org) or in a PDF file (25K). The MHRA can be contacted on 020 7084 2000.

How can pharmacists reassure patients who are concerned about counterfeit medicines? Patients should be reassured that the presence of counterfeit medicines in the legitimate supply chain is unusual and pharmacists take great care to purchase medicines from reputable sources to ensure that this type of incidence does not occur. There will be a full investigation by the authorities to identify how the counterfeit medicine entered the supply chain and action taken to prevent recurrence.

Is there a link between the counterfeit Cialis and Reductil? An investigation is under way into whether there is a link between the two counterfeit products.