Medical Assistance in Dying (MAID) Pharmacy Protocols Aug 16, 2016 Developed in partnership with:

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1 Medical Assistance in Dying (MAID) Pharmacy Protocols Aug 16, 2016 Developed in partnership with: The Alberta College of Pharmacists The Alberta College of Physicians and Surgeons Alberta Health 1

2 Table of Contents Page Guidance Document for the Standardized Prescription Protocols for Medical Assistance in Dying...3 Purpose of this Document.3 Important Definitions... 3 Demographic Information... 4 Verification of the Request... 4 Collaboration... 4 Physician-provided Protocol... 4 Self-administered Protocol... 4 Signature Section... 4 Standardized Prescription Protocols for Medical Assistance in Dying.. 5 Medical Assistance in Dying Protocol Based Drug Information.8 Intravenous Drug Protocol Monographs... 9 Oral Self-administered Drug Protocol Monographs 15 2

3 Guidance Document for the Standardized Prescription Protocols for Medical Assistance in Dying Purpose of this document This guidance document has been developed by the Medical Assistance in Dying Pharmacy Working Group to assist the providing physician and the pharmacist in their understanding and application of the Standardized Prescription Protocols for Medical Assistance in Dying. The Medical Assistance in Dying Pharmacy Working group membership included pharmacists and project staff from Alberta Health Services and representatives from the Alberta College of Pharmacists, the College of Physician and Surgeons and Alberta Health. Protocols from Quebec, Oregon and the Netherlands were reviewed and used to inform the development of the Standardized Prescription Protocols for Medical Assistance in Dying. Deviation from this protocol is discouraged. Important Definitions It is important to be aware that in Alberta, Medical Assistance in Dying has been defined as follows: Medical Assistance in Dying: (a) the administering by a Physician of a substance to a patient, at their request, that causes their death; or (b) the prescribing or providing by a Physician of a substance to a patient, at their request, so that they may self-administer the substance and in doing so cause their own death. Providing Physician: the physician who provides the prescription to the patient for selfadministration or administers the medications intended to cause the patient s death. The providing physician is responsible for confirming that all of the mandatory eligibility criteria have been met before the medications that intentionally cause the patient s death can be provided or administered. There can only be one providing physician for each patient but a second physician may be present to assist. 3

4 Demographic Information The patient and providing physician information is collected as is required on all other medical records which would appear in the patient s medical record. Verification of the Request Providing physician s initials: affirm that the individual has decisional capacity; that the presence of a grievous and irremediable condition has been determined by two physicians; and that the providing physician has received consent from the patient authorizing Medical Assistance in Dying, thus satisfying the mandatory eligibility criteria for Medical Assistance in Dying, established by the Supreme Court of Canada in Pharmacist s initials: affirm that the pharmacist has verified with the providing physician that all assessments have been completed and that the patient has been deemed to satisfy all of these criteria. The intention is NOT that the pharmacist performs an assessment of these critical criteria - all assessments are performed by a physician. Collaboration It is important to ensure that the providing physician and the pharmacist have discussed the items listed below and that they are in agreement that medications intended to cause the patient s death will be dispensed. the protocol selected additional or alternative medications required the scheduled time for the administration of medical assistance in dying the time required to procure and prepare the medications how to complete the medication administration record procedure for returning unused medications to the pharmacy Physician-provided Protocol Includes the medications recommended for the physician-provided protocol. The medications are listed in the order of administration. Self-administered Protocol Includes the medications recommended to be prescribed for the patient as part of the selfadministered protocol. The medications are listed in the order of administration. Signature Section Intended to record the names of those involved in the prescribing and assessment of the medications. 4

5 Standardized Prescription Protocols for Medical Assistance in Dying The MAID prescription is comprised of the following three pages. Ensure all pages are printed. Demographic Information Patient Name: DOB: PHC/ULI: Address: Physician Name: CPSA Registration Number: Telephone Number: Address: Allergies: Verification of Request The providing physician shall affirm and initial all of the criteria. Prior to processing the prescription, the pharmacist shall verify with the providing physician that all assessments have been completed and that the patient has been deemed to satisfy all of these criteria. I have: Dr. Initials Pharm Initials affirmed that the patient has been assessed to have decisional capacity; affirmed that the patient has been determined to suffer from a grievous and irremediable medical condition; and affirmed that the patient has provided consent for Medical Assistance in Dying Collaboration The providing physician and the pharmacist must discuss: the protocol selected Dr. Initials Pharm Initials additional or alternative medications required the scheduled time for the provision of Medical Assistance in Dying the time required to prepare the medications how to complete the medication administration record procedure for returning unused medications to the pharmacy In the event of failure to die or an extended dying period after the administration of the oral protocol, the decision may be made to proceed with the IV protocol. Active consent to proceed to the IV protocol will have to be obtained at the time of consent being obtained for medical assistance in dying and will be part of the consent for the procedure. Arrangements must be made with pharmacy in advance to ensure the IV protocol is available to the providing physician in the case that conversion is required. Refer to the Protocol Based Drug Information below for detailed instructions on medication prescribing and preparation. 5

6 Physician-provided Protocol (initial to indicate medications being ordered) Pharmacy should supply medications in a ready-to-administer format. If not possible, provide vials/ampoules for the physician to prepare at the bedside. 1. Anxiolytic midazolam mg IV over 2 minutes Dispense: 10 mg Dr. Initials 2. Local Anaesthetic (choose either option a or b as appropriate) 2a) lidocaine 40 mg IV over 30 seconds Dispense: 20 mg/ml pre-filled syringe (1 x 5 ml syringe) OR (if allergic to lidocaine) 2b) magnesium sulfate 1000 mg (diluted with normal saline) IV over 5 minutes Dispense: 1000 mg 3. Normal Saline Flush Flush IV with 10 ml normal saline to prevent any incompatibility with coma-inducing agent Dispense: normal saline flush syringe (1 x 10 ml) 4. Coma-inducing Agent (choose either option a or b as appropriate) Note: if a deep coma cannot be confirmed, an additional dose of the coma-inducing agent may be required 4a) propofol 1000 mg IV over 5 minutes Dispense: 1000 mg OR (if allergic/intolerant to propofol) 4b) phenobarbital 3000 mg (diluted with normal saline) IV over 5 minutes Dispense: 3000 mg 5. Normal Saline Flush Flush IV with 10 ml normal saline to prevent incompatibility between coma-inducing agent and neuromuscular blocker and to ensure full dose is administered Dispense: normal saline flush syringe (1 x 10 ml) 6. Neuromuscular Blocker (choose either option a or b as appropriate) 6a) rocuronium 200 mg by rapid IV injection Dispense: 200 mg OR (if rocuronium is unavailable) 6b) cisatracurium 30 mg by rapid IV injection Dispense: 30 mg 7. Normal Saline Flush Flush IV with 10 ml normal saline to ensure full dose of neuromuscular blocker is administered Dispense: normal saline flush syringe (1 x 10 ml) 6

7 Self-administered Protocol (initial to indicate medications being ordered) To guide appropriate recipe selection, indicate route of administration of oral coma-inducing compound: oral NG/PEG tube 1. Gastric Motility/Nausea Prevention metoclopramide 20 mg PO/SC/IV one hour prior to ingestion of coma-inducing compound Dispense: 20 mg Dr. Initials 2. Anxiolytic LORazepam mg SL PRN if the patient has significant anxiety Dispense: 2 x 0.5 mg SL tablets NOTE: if patient is benzodiazepine-naïve, a reduced dose of 0.25 mg is recommended (1/2 of a 0.5 mg SL tablet). 3. Coma-inducing Compound phenobarbital powder x 20 g chloral hydrate powder x 20 g morphine sulfate powder x 3 g Omit morphine if patient has had a recent opioid rotation from morphine due to neurotoxicity. Directions: drink coma-inducing compound as quickly as possible (within 4 minutes) and drink another small glass of water immediately following. Dispense as a suspension. Oral coma-inducing compound suspension recipe provided in the Oral Selfadministered Drug Protocol Monographs information. 4. Managing Emesis haloperidol 5 mg SC or IV PRN emesis Dispense: 5 mg Some patients will experience nausea and possibly vomiting upon ingesting the coma-inducing compound. Providing physician should make the patient aware of this in advance, and be prepared to intervene and support as appropriate. For either protocol, consultation between the physician and pharmacist should occur for the following: Opioids: A separate prescription is required if the physician chooses to have an additional opioid on hand. This may be desired for the management of pain, dyspnea, or to prevent withdrawal in the event of a prolonged dying event. Additional Quantities: Physicians should consider whether they wish to prescribe additional quantities of medication(s) to compensate for breakage or the possible need for additional dosing. If additional quantities are requested, they should be prescribed, packaged, and dispensed complementary to, but separate from the prescriptions on this protocol. Physician Signature Date Assessing Pharmacist Signature Date 7

8 Medical Assistance in Dying Protocol Based Drug Information WARNING: These drug monographs were prepared for use with the Standardized Prescription Protocols for Medical Assistance in Dying only, and are not intended for other purposes. For complete drug use and safety warnings please consult other sources. Due to the special context of medical assistance in dying, shortened beyond use dates are assigned in these monographs to ensure the medications are used promptly. The assigned beyond use dates in the Intravenous Drug Protocol Monographs apply to medications prepared in a sterile environment and may vary from those published. 8

9 Intravenous Drug Protocol Monographs 9

10 Intravenous Drug Protocol Monographs (drugs are listed in order of protocol use) Please Note: to prevent IV incompatibilities, stop all other infusions and flush the IV line with 10 ml normal saline before proceeding. If this is not feasible, start a second IV line dedicated for MAID administration. 1. Anxiolytic Midazolam Compatible with: Y-site: atracurium, cisatracurium, fentanyl, haloperidol, HYDROmorphone, insulin, LORazepam, morphine, pancuronium, propofol, remifentanil, SUFentanil, vecuronium MAID Administration Required: midazolam 1 mg/ml (10 ml vial) Directions: withdraw 10 ml into a 20 ml syringe Dose: mg IV over 2 minutes Beyond use date: 24 hours at room temperature in syringe NOTE: Patient may remain awake or may lose consciousness depending on sensitivity to benzodiazepines. 2. Local Anaesthetic (choose either option a or b as appropriate) 2a. Lidocaine Compatible with: Y-site: fentanyl, haloperidol, HYDROmorphone, insulin, morphine, SUFentanil MAID Administration Required: lidocaine 20 mg/ml pre-filled 5 ml syringe Directions: no preparation required Dose: 40 mg (2 ml) IV over 30 seconds Dosing Considerations and Options Caution: DO NOT administer lidocaine WITH epinephrine IV. 10

11 2b. Magnesium Sulfate (if allergic to lidocaine) Compatible with: Y-site: fentanyl, midazolam, morphine, phenobarbital, SUFentanil MAID Administration Required: magnesium sulfate 200 mg/ml (1 x 10 ml vial) Directions: withdraw 1000 mg (5 ml) into a 20 ml syringe and further dilute with normal saline to a final volume of 10 ml Dose: 1000 mg IV over 5 minutes Beyond use date: 24 hours at room temperature in syringe 3. IV Line Flush Ten (10) ml of normal saline must be injected prior to the coma-inducing agent to prevent any incompatibility. 4. Coma-inducing Agent 4a. Propofol Incompatible with: Y-site: atracurium, cisatracurium, metoclopramide, morphine sulfate at high concentrations (compatible at 1 mg/ml) Do not mix with other drugs prior to administration. Flush line with 10 ml normal saline to ensure complete dose administered and to prevent precipitation due to incompatibilities. Compatible with: Y-site: fentanyl, HYDROmorphone, ketamine, lidocaine, midazolam, magnesium sulfate, morphine sulfate at 1 mg/ml, vecuronium MAID Administration Required: propofol 10 mg/ml (100 ml vial) Directions: withdraw 50 ml into a 60 ml syringe. Prepare 2 syringes of 50 ml each. If an additional dose is prescribed, prepare a third syringe. Dose: 1000 mg IV (infuse each syringe over 2.5 minutes). May give additional dose of 500 mg if required. Dosing Considerations and Options Storage: Store at room temp, protect from light, do not use if there is evidence of separation of phases of emulsion. 11

12 Beyond use date: 24 hours at room temperature in syringe CAUTION: Loss of consciousness should occur rapidly during the first minute of propofol administration. Propofol may be painful to inject which is the reason for administration of lidocaine prior to the propofol. Cardiovascular and respiratory depression can occur with this dose of propofol. Even if this occurs, proceed with neuromuscular blocker. Coma must be confirmed prior to administration of a neuromuscular blocker. If a deep coma (see Artificial Coma Criteria and Richmond Agitation-Sedation Scale below) cannot be confirmed, then the dose must be increased by adding an additional 500 mg of propofol as required. Artificial Coma Criteria (adapted from Quebec Protocol) Physiological Criteria Clinical Signs Level of consciousness Unable to arouse No response to verbal commands, No protective reflexes (loss of corneal reflex in particular) Richmond Agitation Sedation Scale (RASS) Score Term Description +4 Combative Overtly combative or violent; immediate danger to staff +3 Very agitated Pulls on or removes tube(s) or catheter(s) or has aggressive behavior toward staff +2 Agitated Frequent nonpurposeful movement or patient ventilator dyssynchrony +1 Restless Anxious or apprehensive but movements not aggressive or vigorous 0 Alert and calm Spontaneously pays attention to caregiver -1 Drowsy Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact, to voice -2 Light sedation Briefly (less than 10 seconds) awakens with eye contact to voice -3 Moderate sedation Any movement (but no eye contact) to voice -4 Deep sedation No response to voice, but any movement to physical stimulation -5 Unarousable No response to voice or physical stimulation 12

13 4b. phenobarbital for Injection (if allergic/intolerant to propofol) Compatible with: Y-site: fentanyl, HYDROmorphone (may be incompatible at high concentrations of both), methadone, morphine, propofol, SUFentanil MAID Administration Required: phenobarbital 120 mg/ml (25 x 1 ml ampoules) Directions: withdraw 25 ml into a 60 ml syringe. Further dilute with normal saline to total volume of 50 ml. If an additional dose is prescribed, prepare a second syringe. Dose: 3000 mg IV over 5 minutes. May give additional dose of 3000 mg if required. Beyond use date: 24 hours at room temperature in syringe Coma must be confirmed prior to administration of a neuromuscular blocker. If a deep coma (see Artificial Coma Criteria and Richmond Agitation-Sedation Scale above) cannot be confirmed, then the dose must be increased by adding an additional 3000 mg of phenobarbital as required. 5. IV Line Flush Ten (10) ml of normal saline must be injected between the coma-inducing agent and the neuromuscular blocker to ensure that the full dose of coma-inducing agent has been injected into the vein and to prevent a precipitate from forming in the IV tubing. 6. Neuromuscular Blocker (choose either option a or b as appropriate) 6a. Rocuronium Compatible with: Y-site: fentanyl, haloperidol, HYDROmorphone, magnesium sulfate, morphine, ondansetron, phenobarbital, remifentanil, SUFentanil. MAID Administration Required: rocuronium 10 mg/ml (4 x 5 ml vials) Directions: withdraw 20 ml into a 30 ml syringe Dose: 200 mg by rapid IV injection Beyond use date: 24 hours at room temperature in syringe 13

14 6b. Cisatracurium (if rocuronium is unavailable) Compatible with: Y-site: alfentanil, fentanyl, haloperidol, HYDROmorphone, magnesium sulfate, morphine, ondansetron, remifentanil, SUFentanil. MAID Administration Required: cisatracurium 2 mg/ml (2 x 10 ml vials) Directions: withdraw 15 ml into a 20 ml syringe Dose: 30 mg by rapid IV injection Beyond use date: 24 hours at room temperature in syringe Cautions: Intravenous injection of a sufficient dose of neuromuscular blocker causes paralysis of the striate muscles (except the myocardium) within minutes. The resulting respiratory arrest leads to death by anoxia. Death can come very quickly once the neuromuscular blocker has been injected, if it did not already occur during coma induction. Respiratory arrest occurs before cardiac arrest. There may sometimes be a delay of up to 20 minutes between respiratory arrest and cardiac arrest, causing cyanosis. It is advisable to explain to those present, before starting the injections, that death might come relatively quickly and that the heart may keep beating for a long time after breathing has stopped. 7. IV Line Flush Ten (10) ml of normal saline must be injected after the neuromuscular blocker to ensure that the full dose has been injected into the vein. 14

15 Oral Self-administered Drug Protocol Monographs 15

16 Oral Self-administered Drug Protocol Monographs (drugs are listed in order of protocol use) 1. Gastric Motility/Nausea Prevention Metoclopramide Contraindications: Hypersensitivity to metoclopramide, GI hemorrhage, mechanical obstruction, perforation, history of seizures, pheochromocytoma (may precipitate hypertensive crisis). MAID Administration Required: metoclopramide (oral and/or injectable as ordered by prescriber) Dose: 20 mg PO/SC/IV 1 hour prior to coma-inducing compound to promote motility and decrease nausea and vomiting Dosing Considerations and Options: For patients with a history of nausea consider 10 mg PO/SC/IV TID 24 hours prior to procedure. If intolerance exists to metoclopramide, ondansetron 8 mg PO/SC/IV can be substituted; noting that it lacks the prokinetic effects of metoclopramide. 2. Anxiolytic LORazepam Sublingual Tablets (PRN) MAID Administration (optional) Required: LORazepam 0.5 mg SL (2 tablets) Dose: mg SL PRN if the patient has significant anxiety Dosing Considerations and Options: Over-sedation can prevent the ability to swallow the oral coma-inducing compound. For benzodiazepine-naïve debilitated patients, 0.25 mg (1/2 of 0.5 mg tablet) is recommended. If the patient has a known sensitivity to benzodiazepines then LORazepam should be omitted. Initial daily dose in elderly and debilitated patients should not exceed 0.5 mg and should be very carefully and gradually adjusted, depending upon tolerance and response. 16

17 3. Coma-inducing Compound IMPORTANT: must contain phenobarbital and chloral hydrate powders. Omit morphine powder if patient has had a recent opioid rotation from morphine due to neurotoxicity. *Drink suspension as quickly as possible (within 4 minutes) to prevent loss of consciousness before complete ingestion. Oral Coma-inducing Compound Suspension Recipe (Adapted from P-C-M Suspension Formulation, Union Avenue Compounding Pharmacy, Tacoma WA) Part 1: Powder Component phenobarbital powder USP 20 g* *active ingredients chloral hydrate powder USP 20 g* morphine sulfate powder USP 3 g* (if appropriate) acesulfame potassium powder steviol glycosides 95% powder Magnasweet 135 powder 365 mg 370 mg 360 mg Part 2: Suspending Liquid for Oral Administration Flavor, Tutti Frutti 3.6 ml Flavor, Marshmallow 2.4 ml Distilled water 20 ml Ora-Plus 32 ml Ora-Sweet 32 ml Part 2 Alternative: Suspending Liquid for NG or PEG Tube Administration Ora-Plus 27 ml Distilled water 63 ml After administration, the g-tube should be flushed with ml of water to ensure complete dosing. Instructions: Prepare in an engineering control that provides adequate mechanical ventilation. An externally vented biological safety cabinet (BSC) or fume hood, or a powder containment hood is recommended to prevent occupational exposure. Follow standard processes for personal protective equipment as applicable to the compounding environment. Use an enclosed scale to weigh the powders within the engineering control. Put all powders in a mortar and pestle and triturate well. Slowly add suspending liquid to the powders, mixing thoroughly. 17

18 Transfer suspension to a 250 ml amber glass bottle for dispensing (Note: chloral hydrate powder is caustic and is incompatible with plastic containers). Label with Shake Well and WARNING: Contains lethal dose auxiliary labels. The beyond use date for the mixed suspension is 14 days at room temperature from the time of preparation. When preparing the patient-specific labels, assign a beyond use date of 72 hours from the time of dispensing. This is to ensure prompt use of the suspension. Decontaminate the engineering control after the compounding process is complete. Refer to medication MSDS sheets for further information. phenobarbital Powder Contraindications: Hypersensitivity, porphyria Chloral Hydrate Powder Contraindications: Hypersensitivity/idiosyncrasy to chloral derivatives Cautions: untreated gastritis or ulcers Morphine Sulfate Powder Omit morphine powder if patient has had a recent opioid rotation from morphine due to neurotoxicity. Prescription Information for Oral Coma-inducing Compound The standardized prescription protocol only lists the active ingredients. Pharmacists are to dispense the coma-inducing compound as an oral suspension per the above recipe. Patient Instructions/Information: a) The patient should not consume lactulose or other laxatives within 24 hours prior to taking the oral coma-inducing compound. b) The patient should not eat or drink for 4-5 hours prior to ingestion of the oral coma-inducing compound. Because this mixture is bitter and can cause a burning sensation, a room temperature non-fat liquid such as non-carbonated soda, fruit juice, liqueur, or water can be taken after ingestion. The oral coma-inducing compound should not be taken if the patient is vomiting or unable to swallow the suspension. 18

19 The entire quantity of the coma-inducing compound should be consumed in less than 4 minutes. The patient should say his final farewells prior to consumption as loss of consciousness can occur very rapidly after ingestion. Less than one percent of persons have awakened after taking this coma-inducing compound. There should be a back-up plan with a physician ready to administer medication to keep the patient comfortable in the unlikely event of awakening. Possible Complications: a) Emesis after ingestion: treat with haloperidol 5 mg SC/IV stat. b) In the event of failure to die or an extended dying period after the administration of the oral protocol, the decision may be made to proceed with the IV protocol. Active consent to proceed to the IV protocol will have to be obtained at the time of consent being obtained for medical assistance in dying and will be part of the consent for the procedure. 4. Managing Emesis Haloperidol Injection (PRN) In case of emesis after administration of the oral protocol, the physician must be in attendance to assess the need to proceed with the IV protocol. Contraindications: documented hypersensitivity MAID Administration Required: haloperidol 5 mg/ml injection (1 x 1 ml vial) Dose: 5 mg SC or IV PRN emesis 19