Fentanyl is classified as a Schedule 2 controlled drug under the Misuse of Drugs Act 1971, and is consequently subject to a number of restrictions including safe custody, record keeping, destruction, and prescription requirements.
Safe custody
All fentanyl products should be stored in a "locked safe, cabinet or room which is constructed to prevent unauthorised access."
Prescription requirements
Prescriptions for schedule 2 controlled drugs must comply with the following:
- Signed by a doctor registered in the UK or an EEA country.
- Full drug details including drug name, strength, form and quantity to supply in words and figures.
- Good practice for quantity prescribed to not exceed 30 days treatment.
- Valid for 28 days from "appropriate date."
- Private prescriptions must be written on the standardised FP10PCD form or equivalent.
- Full dose including the number of patches to apply and the frequency of application.
- "As directed" is not a legally valid dose.
- "Apply one every 72 hours" is a legally valid dose.
- "Apply one as directed" is considered legally valid but does not provide the patient with sufficient information to safely administer the patch; the prescriber should be encouraged to include a more comprehensive dose.
Record keeping
- Records of receipt must include date of receipt, quantity and name and address of supplier. Records of supply must include date of supply, name and address of person supplied, details of who authorised the supply, e.g. prescriber, quantity supplied, identity of the person collecting the drug and whether they were asked for or provided proof of identity.
- CD register entries should be chronological, made promptly, be in ink or indelible, be unaltered.
- Running balances should be kept for good practice .
Destruction
- Destruction of expired, obsolete or unwanted stock should be witnessed by an authorised person.
- Good practice for destruction of patient returns to be witnessed.
- Matrix patches should be denatured by removing the backing and folding the patch over on itself before placing in a CD denaturing kit.
- Reservoir patches can be cut and the gel or solution emptied into the denaturing kit. Care must be taken to avoid any direct contact with the contents of the patch. The emptied patch must also be discarded in the denaturing kit.