Long Term Care Formulary HCD - 08

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1 1 of 5 PREAMBLE Opioids are an important component of the pharmaceutical armamentarium for management of chronic pain. The superiority of analgesic effect of one narcotic over another is not generally suggested by evidence; rather agents tend to be differentiated clinically in terms of tolerance and ability to obtain desired analgesia without undue adverse effects. Fentanyl is different from other long-acting opioids in it s mode of delivery. It is a significantly potent opioid and is best reserved for individuals who either need a topical delivery form or who have not achieved therapeutic goals with other opioid analgesics. It is not recommended for use in opioid-naïve individuals, or for individuals with a limited life expectancy of hours to days. Because of its potency, fentanyl is reserved for those individuals who have required at least 60 mg * of oral morphine equivalents on a daily basis for 1 week or longer. PROTOCOL Approved under the following conditions: 1. Residents with persistent, severe, chronic pain who require continuous around-the-clock analgesia for an extended period of time but who cannot swallow or who have a malabsorption syndrome leading to inability to benefit from long acting opioid preparations. 2. Residents with persistent, severe chronic pain who require continuous around-the-clock analgesia for an extended period of time and who require opioid therapy at a total daily dose of at least 60 mg/day oral morphine equivalents. Patients must have tried and failed with at least two discrete courses of therapy with two of the following agents: morphine, hydromorphone and oxycodone, if not contraindicated. A discrete course is defined as a separate treatment course, which may involve more than 1 agent, used at one time to manage the patient's condition. A failed opioid trial occurs when dosage titration to achieve pain control is not possible due to unacceptable side effects such as uncontrollable nausea & vomiting, distressing hallucinations, excessive sedation and severe cognitive impairment. 3. Residents admitted to a continuing care centre receiving opioid therapy covered by this protocol are eligible for continued use of the opioid upon review, unless a change is clinically indicated. 4. Residents residing in a continuing care centre and currently receiving opioid therapy covered by * Some centers have used 30mg oral morphine equivalents as a starting point, but that practice is not in the product monograph and so not recommended by the Long Term Care Pharmacy & Therapeutics Committee

2 2 of 5 this protocol are eligible for continued use of the opioid, unless a change is clinically indicated. 5. The patient s medication profile must be reviewed in full by a pharmacist, whenever a new prescription or dose change for fentanyl patch therapy is received. Patients awaiting transfer from a CHR acute care site to continuing care should have the drug use evaluated, when possible, prior to long term care placement for compliance with criterion 1 or 2. The findings of this evaluation should be communicated to the Long Term Care pharmacy provider by the acute care site to aid in the completion of the High Cost Drug (HCD-08) Funding Request Formfentanyl which would be completed and processed as per the HCD List Policy and Procedure. In the event that use does not comply with criterion 1 or 2, it is reasonable to convert topical fentanyl therapy to an alternate opioid (morphine, hydromorphone, or oxycodone) and route of administration. Notes: 1. The fentanyl patch is not appropriate for unstable pain where there is a requirement for titration to attempt to achieve pain control. Rapid titration is not recommended with fentanyl and should be avoided. When converting to fentanyl from an oral opioid, the dose and effects of an immediate release opioid need to be determined. Once determined, the total daily dose is then converted to an equivalent fentanyl dose based on manufacturer s conversion tables (see product monograph in the current CPS). The peak effect of the first dose takes hours to be seen. For this reason, overlap of fentanyl with the prior opioid is recommended for the first 12 hours. It is also recommended that the fentanyl patch dose not be titrated more frequently than every 3 days. 2. When switching fentanyl to an alternate oral opioid, it is advisable for the calculated equi-analgesic dose of the second agent to be reduced by 50-60%. Initially titration with an immediate release preparation on a regular scheduled basis with q2h prn for breakthrough pain is recommended. When rotating off the fentanyl patch, remove the patch and start the new opioid 12 hours later. Breakthrough medications should be available during this time and afterwards. 3. The duration of effect is usually 3 days though may vary in some individuals from hours. 4. The effects of the fentanyl patch can continue for 24 hours or more following removal, due to the effect of a subcutaneous depot of fentanyl. 5. It is recommended to use fentanyl patches cautiously when using them in combination with other opioid analgesics, CNS depressants or drugs that affect the metabolism of fentanyl (e.g.,cyp 3A4 inhibitors increase or prolong the effect of fentanyl [e.g., erythromycin, diltiazem, clarithromycin). 6. Application of a heat source to the patch (e.g., heating pad, hot packs), may result in increased release and absorption because of increased skin permeability. Fever may also enhance this effect.

3 3 of 5 7. It is recommended that the documentation process clearly communicates the date, time, and location of patch administered and the date, time, and location of patch to be removed (e.g. by providing prompts on the MAR). 8. It is recommended that an alert is provided on the MAR for patients receiving more than one medication via the transdermal route. PROCEDURE Compliance with the procedure outlined under HCD-02 (High Cost Drug Use Conditions) is necessary for drug cost reimbursement. REFERENCES ISMP Medication Safety Alert, Jun 28,2007 volume 12 Issue 13 ISMP Medication Safety Alert, August 14, 2006, Volume 6, Issue 5 Alberta Blue Cross Drug Benefit List, Duragesic coverage criteria Public advisory: Health Canada endorsed important safety information on Duragesic (fentanyl transdermal system). Ottawa (ON) Health Canada 2005 Sep 16 (cited 2007 Oct 1) Duragesic product monograph, Compendium of Pharmaceutical Specialties Alberta Palliative Care Resource Manual Alberta Cancer Board 2001 The following guidelines for switching to Transdermal (td) Fentanyl as outlined in the 2 nd edition of The Alberta Palliative Care Resource (2001). They have been edited to reflect the CPS 2007 Duragesic monograph. SWITCHING TO TRANSDERMAL (td) FENTANYL Step 1: Step 2: Step 3: CALCULATE THE TOTAL DAILY DOSE OF QUICK RELEASE OPIOID USE MANUFACTURER S CONVERSION TABLE TO CALCULATE THE EQUIVALENT DOSE OF TRANSDERMAL FENTANYL GIVE BREAKTHROUGH ORDERS Since fentanyl cannot be taken orally, the IR formulation of another opioid (e.g.: morphine, hydromorphone or oxycodone) is required for breakthroughs. An alternative approach is to use a parenteral formulation of fentanyl sublingually (especially if there is a significant incidental component to the pain). The dose is limited by the volume required. Volumes

4 4 of 5 exceeding ml are impractical. If the break-through dose requires a volume greater than 2 ml sublingually (parenteral formulation administered SL) then sufentanyl is an option. Calculate the dose of the breakthrough to be 10% of the total fentanyl daily dose (using the manufacturer s tables), eg: a 50 mcg/hour patch is equivalent to mg of oral morphine/24 hours. Morphine 20 mg po q l h prn would therefore be appropriate as a breakthrough order. Step 4: OVERLAP THE TD FENTANYL WITH THE PREVIOUS OPIOID FOR THE FIRST 12 HOURS When initiating the patch, it should be overlapped with the regular, IR opioid for the first 12 hours. (3 scheduled doses of the IR opioid) or one dose of a CR opioid, (i.e. q12h formulations and q24h formulations.) Step 5: Step 6: INITIAL TITRATION OF TD FENTANYL Because of its prolonged action, the transdermal fentanyl dose should only be increased every 3-6 days. Rely on the breakthrough doses to provide extra pain relief in the first 3 days. If more rapid titrations are necessary, they should be done under the guidance of a palliative care physician or pain specialist. THE PATCH SHOULD BE REPLACED EVERY 3 DAYS Rarely, do patients require patches replaced more frequently. Early wearing off of the patch can indicate under-dosing. Example of starting a patient on transdermal fentanyl: It is decided to switch a patient who has been stable on oral morphine 50 mg q4h to transdermal fentanyl. Step 1: Step 2: The total daily dose of morphine is, therefore, 300 mg po. According to the manufacturer s table, the equivalent dose of transdermal fentanyl is approximately 75 micrograms per hour. Rescue doses could be in the form of morphine 30 mg po q l h prn (10% of the total daily dose) or hydromorphone 6 mg q l h prn or oxycodone 15 mg po 1 h prn. The patch should be applied and the previous opioid formulation be continued for another twelve hours. After twelve hours the previous opioid is discontinued and the patient is left on the transdermal fentanyl and immediate release opioid for breakthroughs.

5 5 of 5 APPENDIX B: Table of equianalgesic doses of opioids Table 6: Equianalgesic dose Drug PO Dose PO:SC/IV Ratio SubCut/IV Dose Morphine 10 mg 2:1 5 mg Codeine 100 mg 2:1 50 mg Oxycodone * mg Hydromorphone 2 mg 2:1 1 mg Methadone 1 mg -- too irritating Fentanyl - infusion mcg Fentanyl patch use charts supplied by manufacturer in CPS morphine 10 mg po = codeine 100 mg po = oxycodone mg po = hydromorphone 2 mg po = methadone 1 mg po These tables are guidelines. There exist wide ranges in the dose ratio due to inter-individual variability in response to opioids. When switching opioids the doses should be decreased by a 25-30% and the patient should be monitored during the switch-over until they are stable. Methadone should be started and titrated under the guidance of a palliative care physician or pain specialist. Parenteral fentanyl should also be used under similar guidance. An interesting characteristic of the equianalgesic dose ratio of morphine and other opioids to methadone is that the ratio changes according to the dose of the previous opioid Alberta Health Services. This material is provided on an "as is", "where is" basis. Alberta Health Services does not make any representation or warranty, express, implied or statutory, as to the accuracy, reliability, completeness, applicability or fitness for a particular purpose of such information. This material is not a substitute for the advice of a qualified health professional. Alberta Health Services expressly disclaims all liability for the use of these materials, and for any claims, actions, demands or suits arising from such use. * The equianalgesic dose ratio of morphine to oxycodone is controversial. It appears to be between 1.5:1 and 2:1 Many tables quote the equianalgesic dose ratio of morphine to methadone as being 1:1, i.e., morphine 1mg po = methadone 1 mg po. This ratio was determined using single dose studies. In cancer pain, when multiple doses are required, the ratio of morphine to methadone becomes approximately 10:1, i.e.,morphine 10 mg po = methadone 1 mg po. The equianalgesic dose ratio of morphine to fentanyl has not been accurately determined. It appears to be approximately 100:1, i.e., morphine 1 mg subcut = fentanyl 10 µ (micrograms) subcut. The equianalgesic ratio between parenteral fentanyl and transdermal fentanyl (patch) is also not well described, but appears to be approximately 1:1.

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