Medicines Safety Factsheet No 4 dra Draft FENTANYL PATCHES Safe Prescribing, Dispensing, & Administration of Fentanyl Patches Fentanyl patches are a high-risk opioid. Any errors can have severely negative outcomes. Their inappropriate initiation may cause life-threatening reactions. All staff are alerted to points below. Who may prescribe a Fentanyl Patch Any suitably qualified prescriber, within their range of practice only after approval from: o Acute Pain, Chronic Pain or Palliative Care Team When to prescribe a Fentanyl Patch If patient has chonic severe intractable pain If patient is opioid tolerant – stable chronic dosing of a strong opiate Significant administration issues with regular analgesia: i.e. significant dysphagia, severe nausea/vomiting, platelet / bleeding disorders (where sub-cutaneous infusion inappropriate) When NOT to prescribe a Fentanyl Patch Opioid-naïve patients - risk of life-threatening respiratory depression. Mild, acute, post-operative, or intermittent pain (used prn), or pain that needs rapid titration Pre-existing/aquired respiratory depression eg lung infection, severe asthma, severe COPD etc Paralytic ileus Reduced functional status in the patient or carer and/or poor compliance. Inability to guarantee safe use and storage, e.g. access to patches by children, or patients or close relatives with a history of drug/alcohol abuse, psychiatric illness, or suicide ideation. Pregnancy or breast feeding. Fentanyl Patch Prescribing: At Addenbrooke’s hospital, patients are permitted to use any brand of patch if brought from home. However new supplies will always be changed to a Trust-approved matrix-type patch. Initiation in New Patients: Matrix patch, only on advice of a specialist pain team (see above). Maintenance in Patients Already on Fentanyl Patch Prior to Admission: Prescribe at same or lower dose, and only if clinically appropriate. Contact specialist pain team if there are pain management problems. For Fentanyl 25mcg/hr, patients must be taking at least 90mg/24hours of oral morphine, 45mg/24hours oral oxycodone, or equi-analgesic opioid dose, for at least 1 week. Require stable, continuous, opioid administration for an extended period of time. Dose Frequency, Titration, & Discontinuation: All patches are changed every 72 hours. Do not titrate/increase dose more frequently than every 3 days initially, then every 6days, in increments of 30-50% For first 12-24 hours of fentanyl patch use prescribe ‘prn’ strong opioids for breakthrough pain at 1/6th of 24-hour total opioid dose. Take advice from the specialist team. Patch Removal: Fentanyl continues to release from skin depot, falling to 50% of dose in 17hrs (range 13–22). Opioid withdrawal (nausea,vomiting,diarrhoea,anxiety,shivering etc) may occur after the patch is removed. Drug Interactions: See SPC for full details. CYP3A4 Inhibitors:eg amiodarone, macrolides, verapamil etc increase fentanyl levels causing enhanced therapeutic and adverse effects CNS depressants (eg anaesthetics, sedating antihistamines etc) or muscle relaxants eg Baclofen, potentiate sedation & respiratory depression, but may be appropriate for palliative care patients seek specialist advice Approved by: xxxxx Placed onto electronic library: xxxx. Review date: xxxxx. Authors: David de Monteverde-Robb & Manish Nathwani, Pharmacy Department. Version 2 Common Adverse Effects: Nausea, vomiting, constipation, dizziness, headache, & somnolence. See SPC Fentanyl Patch Induced Respiratory Depression Risk Factors: o High initial dose, rapid dose increase, use on broken skin, ingestion of patch, accidental exposure or patch malfunction. o High-risk patient (e.g. respiratory/neuromuscular disease, elderly, debilitated) o Interaction with drugs causing sedation, respiratory depression, skeletal muscle relaxation or altered metabolism Fentanyl Patch Induced Respiratory Depression Signs: Shallow breathing, bradycardia, extreme sedation, confusion, hallucinations, etc. If signs occur, staff must remove Fentanyl patch(es), and seek urgent medical help. Naloxone injection may be required, but will wear off before the fentanyl skin depot is exhausted – ongoing monitoring required. Do not administer any other opiates, benzodiazepines or other pre-disposing drugs until after a medical review. Patient must have pain team or palliative care input before reinitiating opioids. Complete an incident form. Converting from Other Opioids: always seek advice as above from Pallaitive Care or Pain Team To convert from – 4 Hourly Regular Opioid Medication: Apply patch & continue next 3 doses of regular opioid drugs. 12 Hourly SR Oral Opioids: Apply patch with last dose of SR opioid, then stop SR opioid. Continuous Subcutaneous Infusion: Apply patch, continue syringe driver for 6-12 hrs, then stop infusion. Further Nursing Details for application of Fentanyl Patches: Always remove ALL old patches before applying new patches. Fold old patches in half, adhesive side together, & dispose immediately in clinical waste (hospital). Cleanse skin with water & completely dry before application. Do not apply after emmolient use. Use more than one patch if doses >100mcg/hr are needed. Apply multiple patches at the same time, if necessary changing all existing patches if dose is increased Apply patch to non-irritated, non-hairy skin on flat surface of torso/upper arm. Hold steady for 1 minute. Use adhesive dressing if there are adhesion issues. Avoid touching adhesive side of patch. A new patch must be applied to a different site. Wash hands after application. Do not cut patches without pain team / palliative care team/ pharmacy approval. Document in nursing notes date, time, number of patches applied, and location of application(s) and date/time when these patches should be removed. Check patch placement daily. Effect of Heat on Fentanyl Patches: Increased body temperature & patch exposure to external heat e.g. hot water bottles, sun bathing etc can lead to dangerous rises in fentanyl levels. Do not expose patches to external heat sources. If a patient has a high-grade fever, seek medical advice Pharmacy: Fentanyl patches must not be on any CD stock lists. Pharmacy Maximum Quantity for Supply: o Inpatient use: 2 patches ( 6 days) o TTOs: 5 patches (15 days). o Out-patients: 10 patches (30 days) Clinical Pharmacy Service Check drug history including pre-admission dose, date of application of last patch(es), duration of therapy, current suitability for fentanyl patches as soon as possible after patient admission. Ensure each patient is assessed for appropriate initiation and titration. Monitor high-risk patients known to be using a fentanyl patch; particularly monitor for respiratory depression, dose increases of > 25mcg/hr, worsening renal or hepatic function, additional sedative drugs Approved by: xxxxx Placed onto electronic library: xxxx. Review date: xxxxx. Authors: David de Monteverde-Robb & Manish Nathwani, Pharmacy Department. Version 2