Advice for healthcare professionals:
- fentanyl is a potent opioid – a 12 microgram (µg) per hour fentanyl patch equates to daily doses of oral morphine of up to 45mg a day
- do not use fentanyl patches in opioid-naive patients
- use other analgesics and other opioid medicines (opioids) for non-cancer pain before prescribing fentanyl patches
- if prescribing fentanyl patches, remind patients of the importance of:
- not exceeding the prescribed dose
- following the correct frequency of patch application, avoiding touching the adhesive side of patches, and washing hands after application
- not cutting patches and avoiding exposure of patches to heat including via hot water (bath, shower)
- ensuring that old patches are removed before applying a new one
- following instructions for safe storage and properly disposing of used patches or patches that are not needed (see advice issued previously); it is particularly important to keep patches out of sight and reach of children at all times
- make patients and caregivers aware of the signs and symptoms of fentanyl overdose and advise them to seek medical attention immediately (by dialling 999 and requesting an ambulance) if overdose is suspected
- remind patients that long-term use of opioids in non-cancer pain (longer than 3 months) carries an increased risk of dependence and addiction, even at therapeutic doses (see Drug Safety Update on risk of dependence and addiction with opioids); before starting treatment with opioids, agree with the patient a treatment strategy and plan for end of treatment
- report suspected adverse drug reactions, including dependence, accidental exposure, or overdose associated with fentanyl patches, via the Yellow Card scheme
Review of opioid medicines
Considerable concern has been raised regarding the prescribing of opioids in the UK (see Drug Safety Update on risk of dependence and addiction with opioids). In 2019, the Commission on Human Medicines (CHM) convened an Expert Working Group to examine the benefits and risks of opioids in the relief of non-cancer pain.
During this review it was noted that there have been reports of serious harm, including fatalities, associated with fentanyl patches in both opioid-naive patients and opioid-experienced patients. Up to May 2020, we have received 13 Yellow Card reports in which opioid-naive patients have experienced respiratory depression following use of fentanyl and additional Yellow Card reports in which respiratory depression was reported in patients switched from another opioid to an inappropriately high dose of fentanyl. There was no evidence of intentional overdose in these cases.
There is considerable risk of respiratory depression with the use of fentanyl especially in opioid-naive patients. There is also significant risk with too rapid an escalation of dose, even in long-term opioid users.
Fentanyl is a potent opioid analgesic – a 12 microgram (µg) per hour fentanyl patch equates to daily doses of oral morphine of up to 45mg a day. Because of the risk of significant respiratory depression, in non-cancer patients fentanyl patches should only be used in those who have previously tolerated opioids. CHM has recommended a strengthening of the current warnings and a contraindication for use in opioid-naive patients in the UK for non-cancer pain.
The initial dose of fentanyl should be based on a patient’s opioid history. Please consult the Summaries of Product Characteristics (SmPC) for each medicine for information on starting doses and dose conversion. Prescribers should take into account the morphine equivalence of fentanyl (see morphine equivalence table in SmPCs and from the Faculty of Pain Management).
Advice for patients
On the advice of CHM, the patient information leaflet (PIL) for fentanyl patches has been updated with harmonised headline information regarding their safe use. Please direct both new and current users of fentanyl patches to the updated PIL.
Accidental exposure to transdermal fentanyl can occur if a patch is swallowed or transferred to another individual (see Drug Safety Updates from September 2008 and July 2014). In 2014, following a European review, advice on minimising risk of accidental transfer was added to both the SmPC and the PIL for transdermal fentanyl products. In October 2018, following further reports of deaths by accidental transfer of patches, the MHRA published patient advice (large print version). This can still be used as a resource when discussing with patients how to use and dispose of fentanyl patches safely.
Report to the Yellow Card scheme
Please report medication errors resulting in harm, including overdose and accidental exposure to a medicine, or any other suspected side effects on a Yellow Card.
If a patient experiences any side effect related to dependence or is recognised by the prescriber to be dependent, CHM encourages prescribers, patients, or carers to report this to the MHRA through the Yellow Card scheme with the term ‘dependence’. Use of this specific term will assist the MHRA to monitor further the rates reported in the UK and therefore to further protect public health.
Your report helps to improve the safety of medicines in the UK. Report via the Yellow Card website, Yellow Card App (download at iTunes Yellow Card for iOS devices or at PlayStore Yellow Card for Android devices), or some clinical IT systems (EMIS/SystmOne/Vision/MiDatabank).
Article citation: Drug Safety Update volume 14, issue 2: September 2020: 2.