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Fentanyl iontophoretic transdermal system withdrawal

30th September 2008

Janssen-Cilag Ltd are recalling all Ionsys iontophoretic transdermal system (fentanyl 40 microgram per dose) stock, irrespective of batch number in the UK. Some units of one batch of the transdermal system have been found to self-activate which has the potential to cause overdose. The device should be removed from patients immediately, alternative analgesia provided and patients monitored.
No other fentanyl products from Janssen-Cilag are affected. Medical information can be obtained from Janssen-Cilag Ltd (0800 0323013), returns and credit enquiries (01494 567400). The full MHRA withdrawal notice can be downloaded from the link below.

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New BNF 56 available

17th September 2008

The latest edition of the British National Formulary (number 56, September 2008) is now available in print and on-line.

BNF website
What's new in BNF56

PCF3 receives 5 star review

9th September 2008

We are delighted to report that PCF3 has received a 5 star review in the September 2008 issue of Palliative Medicine.
The review is available on-line from the link below (subscription required).

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MHRA warning on fentanyl patches

3rd September 2008

The MHRA have highlighted the risks of serious and fatal opioid overdose from erroneous prescribing, incorrect application and use of fentanyl patches in their latest drug safety update. The recommendations are similar to those issued by the US FDA in 2005 which have been encompassed in the PCF3 fentanyl monograph and guidelines on the use of transdermal fentanyl patches and can be found in the formulary section on this website.

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MHRA statement on mixing drugs in syringe drivers

2nd September 2008

The MHRA have issued a statement on non-medical prescribing and mixing medicines in palliative care. This follows concern from palliative care health professionals on previous MHRA advice stating that the mixing of two or more medicines prior to administration constitutes the manufacture of an unlicensed product and the implications this has for non-medical prescribing. The statement can be downloaded from the link below.
In summary, the MHRA stand by their original statement. However, having met with palliative care representatives, they recognise that palliative care requires special consideration and would not wish to obstruct the provision of effective pain relief to patients. This may lead to a change in medicines legislation. In the meantime the MHRA would not consider enforcement action for breaches of medicines legislation by a nurse or pharmacist independent prescriber engaging in the long standing accepted practice of prescribing and administering (and providing directions to others to administer) a mixture of licensed medication via a single injection or a syringe driver unless it would be in the public interest to do so. This also applies to those mixing and administering medicines in accordance with the directions of the prescriber.

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