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Medical Assistance in Dying British Columbia Pharmacy Protocols Guidance on the Standardized Pharmacy Protocols and Completion of the Pre-printed Prescription Order Form For Physicians and Nurse Practitioners administering Medical Assistance in Dying, and for Pharmacists dispensing medications for Medical Assistance in Dying Not For General Distribution December 5, 2016 Developed by the Provincial Medical Assistance in Dying Working Group: Sub-Committee on Pharmacy Health Authorities of BC College of Pharmacists of BC College of Physicians and Surgeons of BC College of Registered Nurses of BC BC Pharmacy Association Canadian Society of Hospital Pharmacists (BC Branch) BC Ministry of Health Table of Contents Page PURPOSE……………………………………………………………………………………………………………. 3 IMPORTANT DEFINITIONS………………………………………………………………………………………….. 3 BC’S STANDARDIZED PHARMACY PROTOCOLS FOR MEDICAL ASSISTANCE IN DYING............................. 5 GUIDANCE ON COMPLETING SECTIONS OF THE PRE-PRINTED PRESCRIPTION ORDER FORM………….... 5 Prescription Submission and Retention…………………………………………………………………. 5 Identification and Declaration…………………………………………………………………………….. 5 Intravenous Drug Protocol – Administered by Medical / Nurse Practitioner………………………… 6 Oral Drug Protocol – Self-Administered (Supervised by Medical / Nurse Practitioner)……………. 6 Prescription Planning……………………………………………………………………………………… 7 Planned Date and Time of Prescription Release……………………………………………… 7 Plan for Concluding Medical Assistance in Dying Process.................................................. 7 Prescription Accountability……………………..……………………………………………………….... Medication Administration Record (MAR)……………………………………………………… Dispensing Sign-Off………………………………………………………………………………. Return of All Unused and Partially Used Medications to Pharmacist for Disposal………… 7 7 7 7 Medication Administration Record……………………………………………………………………….. 8 Acknowledgements………………………………………………………………………………………... 8 BRITISH COLUMBIA MEDICAL ASSISTANCE IN DYING PRESCRIPTION AND MAR (SAMPLE)……………… 9 MEDICAL ASSISTANCE IN DYING DRUG PROTOCOL MONOGRAPHS…………………………………………. 15 Intravenous Drug Protocol Monographs………………………………………………………………… 16 Oral Self-Administered Drug Protocol Monographs…………………………………………………… 24 SUGGESTED COMPOUNDING PROCEDURE (ORAL COMA-INDUCING SUSPENSION)…………………...…… 30 SUGGESTED INVENTORY LISTS…………………………………………………………………………………… 31 Suggested Pharmacy Inventory Lists (Per Kit) for IV and Oral Regimens…………………………. 31 Suggested Inventory List for IV Insertion Equipment and Additional Supplies Required by Practitioner for Medication Administration…................................................................................... 33 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 2 Purpose / Important Definitions PURPOSE This guidance document has been developed by the provincial Medical Assistance in Dying Working Group: Sub-Committee on Pharmacy, to assist the providing physician or nurse practitioner and the pharmacist in their understanding of British Columbia’s standardized pharmacy protocols, and to provide support for the completion of the pre-printed prescription order form for medical assistance in dying. The document includes the following information: Important definitions pertaining to medical assistance in dying, including information on the roles and responsibilities of practitioners and pharmacists in British Columbia. British Columbia’s standardized pharmacy protocols for medical assistance in dying. Guidance for completing the “British Columbia Medical Assistance in Dying Prescription” form. Sample “British Columbia Medical Assistance in Dying Prescription” form (including Prescription Planning and Accountability sections, and Medication Administration Record). Drug information monographs for the intravenous and oral drug protocols. Suggested compounding procedure for the oral coma-inducing compounded suspension. Suggested inventory lists for intravenous and oral drug regimens. Suggested inventory list for intravenous insertion equipment and supplies. The membership of the Medical Assistance in Dying Committee on Pharmacy included pharmacists and physicians from the BC Health Authorities, representatives from the regulatory colleges for pharmacists, physicians and registered nurses, and representatives from the BC Pharmacy Association, the Canadian Society of Hospital Pharmacists (BC Branch) and the BC Ministry of Health. Protocols from Alberta, Nova Scotia, Quebec, Oregon and the Netherlands were reviewed and used to inform the development of the British Columbia Standardized Pharmacy Protocols for Medical Assistance in Dying. IMPORTANT DEFINITIONS CANADA The following definitions pertaining to medical assistance in dying are defined in Section 241.1 of the Criminal Code of Canada (amended 2016-06-17): “medical assistance in dying” means (a) the administering by a medical practitioner or nurse practitioner of a substance to a person, at their request, that causes their death; or (b) the prescribing or providing by a medical practitioner or nurse practitioner of a substance to a person, at their request, so that they may self-administer the substance and in doing so cause their own death. medical practitioner means a person who is entitled to practice medicine under the laws of a province nurse practitioner means a registered nurse who, under the laws of a province, is entitled to practice as a nurse practitioner – or under an equivalent designation – and to autonomously make diagnoses, order and interpret diagnostic tests, prescribe substances and treat patients. pharmacist means a person who is entitled to practise pharmacy under the laws of a province.” BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 3 Important Definitions BRITISH COLUMBIA The following further defines the roles and responsibilities of the prescribing medical or nurse practitioner and pharmacist with regard to medical assistance in dying in British Columbia: Prescribing Medical / Nurse Practitioner (Prescriber): The prescribing medical or nurse practitioner (prescriber) who administers the lethal dose of medications intended to cause the patient’s death, or provides the lethal dose of medications to the patient for self-administration. The prescriber 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 administered or provided to the patient for self-administration. There can only be one prescriber for each patient; however, a second medical / nurse practitioner or nurse may be present to assist. In British Columbia, the prescriber must personally attend the patient during the administration or self-administration of medical assistance in dying and must remain in attendance until death is confirmed. For additional information on the role and responsibilities of the prescriber, please see the Professional Standards and Guidelines for Medical Assistance in Dying posted by the College of Physicians and Surgeons of British Columbia (CPSBC), and the Scope of Practice for Nurse Practitioners posted by the College of Registered Nurses of British Columbia (CRNBC), which are available at the following links: https://www.cpsbc.ca/files/pdf/PSG-Medical-Assistance-in-Dying.pdf https://crnbc.ca/Standards/Lists/StandardResources/688ScopeforNPs.pdf Pharmacist: Only a full pharmacist can dispense drugs for the purpose of medical assistance in dying, and the full pharmacist must dispense directly to the prescribing medical or nurse practitioner (prescriber), as per the following: Dispensed drugs for the purpose of medical assistance in dying must be transported between the pharmacist and the prescriber only. In exceptional circumstances, this transport can be completed by a safe and secured courier (with terms and conditions that align with federal legislation, particularly the Controlled Drugs and Substances Act [CDSA] and the Narcotic Control Regulation). Telepharmacy remote sites are not eligible to dispense drugs for the purpose of medical assistance in dying, since there is no full pharmacist on-site. Registrants are encouraged to be mindful of their Code of Ethics and use their professional judgment in ensuring pharmacy services are completed with public interest and patient safety in mind. The pharmacist must review the prescription and discuss and confirm with the prescriber the patient’s eligibility and consent for medical assistance in dying, the patient’s drug therapy and the drug protocol selected, as well as other details pertaining to the ordering, preparation, dispensing, documenting, and return of unused drugs. A full pharmacist may delegate to a pharmacy technician any aspect of the preparation of drugs for the purpose of medical assistance in dying that is within a pharmacy technician’s scope of practice. For additional information on the role and responsibilities of the full pharmacist and pharmacy technician, please see Dispensing Drugs for the Purposes of Medical Assistance in Dying posted by the College of Pharmacists of British Columbia, available at the following link: http://library.bcpharmacists.org/6_Resources/6-1_Provincial_Legislation/5195HPA_Bylaws_MAID.pdf BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 4 BC’s Standardized Pharmacy Protocols / Guidance on Completing Sections of the Prescription BC’S STANDARDIZED PHARMACY PROTOCOLS FOR MEDICAL ASSISTANCE IN DYING British Columbia’s standardized pharmacy protocols for medical assistance in dying include the following: 1) Intravenous Drug Protocol – for medical or nurse practitioner-administered medical assistance in dying; and, 2) Oral Drug Protocol – for self-administered medical assistance in dying. The Intravenous Drug Protocol is the recommended and most often selected option, due to its more rapid onset of effect and reduced likelihood of complication. If the Oral Drug Protocol is selected, intravenous access must also be established in the patient so that the intravenous regimen can be administered in the event the oral regimen is ineffective. Specific details on the intravenous and oral drug protocols are provided in the attached sample British Columbia Medical Assistance in Dying Prescription. Additional information on each medication is provided in the attached Intravenous Drug Protocol Monographs and Oral Drug Protocol Monographs. GUIDANCE ON COMPLETING SECTIONS OF THE PRE-PRINTED PRESCRIPTION ORDER FORM Prescription Submission and Retention Instructions regarding submission and retention are provided at the top of page one of the prescription. Upon completion of medical assistance in dying: 1) The prescribing medical or nurse practitioner (prescriber) will provide a copy of the completed medication administration record (MAR) to the pharmacist for reconciliation of the return of all unused and partially used medications (which will be documented in the “Prescription Accountability” section of the prescription). 2) The pharmacist will provide a copy of the completed prescription sections (including the Prescription, and the “Prescription Planning” and “Prescription Accountability” sections) to the prescriber, since it is the responsibility of the prescriber to submit all completed forms for medical assistance in dying to the BC Coroners Service. 3) The prescriber will fax a copy of the completed prescription document (all sections, including the prescription, prescription planning and accountability sections, and the MAR), along with all other completed forms for medical assistance in dying, to the BC Coroners Service, Attention Deputy Chief Coroner, fax 604-660-7766. 4) For cases involving a health authority (HA), the prescriber will fax or mail an additional copy of the prescription (all sections) to the applicable HA (fax numbers and mailing instructions are provided at the bottom of page 4 of the prescription). 5) The prescriber will retain a copy of the prescription (all sections) in the patient’s health record. Identification and Declaration The patient and prescribing medical or nurse practitioner (prescriber) information is recorded here, as is required on all other medical records which would appear in the patient’s medical record. Patient Information – The prescriber will record the following patient information: name, birthdate, address, personal health number, and medical information pertinent to medical assistance in dying (e.g., allergies). BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 5 Guidance on Completing Sections of the Prescription Medical / Nurse Practitioner Information (Prescriber) – The prescriber will record their name, college identification number (CPSID #, or CRNBC Prescriber #), address, telephone number and signature. Medical / Nurse Practitioner Declaration (Prescriber) – The prescriber will initial each of four statements to declare them true (e.g., statement on determination that the patient is capable of providing consent, and statement on determination that the patient has a grievous and irremediable medical condition and meets the eligibility criteria). The prescriber also records the name of the other medical / nurse practitioner who completed an assessment and confirmed that the patient meets the eligibility criteria. The pharmacist will initial only the first statement to acknowledge discussion and confirmation with the prescriber that the medications prescribed on the form are intended for the purpose of medical assistance in dying, and that the patient’s drug therapy has been discussed. The pharmacist is not to perform an assessment of the patient’s eligibility criteria or obtain consent from the patient (functions performed by the prescriber only). Intravenous Drug Protocol – Administered by Medical / Nurse Practitioner The prescribing medical or nurse practitioner (prescriber) must record the patient’s name, birthdate, and personal health number. The medications recommended to be prescribed for the medical or nurse practitioner-administered intravenous drug protocol are listed in a table in the order of their administration. The row for each medication includes information on the dispensed quantity and dosage regimen, a space for prescriber notes, and a space that the prescriber must initial to indicate the medication is prescribed for the intravenous drug protocol. The prescriber must provide their signature at the bottom of the page and record their college ID number (CPSID #, or CRNBC Prescriber #). The pharmacist must dispense two identical kits of all medications in a sealed / tamperproof container, to ensure that a backup intravenous kit is available if required. (The Intravenous Drug Protocol Monographs attached to this document provide information on each medication, including instruction on confirming coma prior to administration of the neuromuscular blocker.) Oral Drug Protocol – Self-Administered (Supervised by Medical / Nurse Practitioner) The prescribing medical or nurse practitioner (prescriber) must record the patient’s name, birthdate, and personal health number. The medications recommended to be prescribed for the patient self-administered oral drug protocol are listed in a table in the order of their administration. The row for each medication includes information on the dispensed quantity and dosage regimen, a space for prescriber notes, and a space that the prescriber must initial to indicate the medication is prescribed for the oral drug protocol. The prescriber must provide their signature at the bottom of the page and record their college ID number (CPSID #, or CRNBC Prescriber #). Note to Prescribing Medical / Nurse Practitioner: The prescriber must also complete the Intravenous Drug Regimen section of the Prescription, to prescribe the specific contents of the backup intravenous kit. Note to Pharmacist: The backup intravenous kit should include two orders of proPOFol or phenobarbital (i.e., total dispensed quantity of “2” x 1000 mg of proPOFol, or “2” x 3000 mg of phenobarbital). BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 6 Guidance on Completing Sections of the Prescription (The Oral Self-Administered Drug Protocol Monographs attached to this document provide information on each medication.) Prescription Planning The prescribing medical or nurse practitioner (prescriber) must record the patient’s name, birthdate, and personal health number. This section includes information on the planned date and time of prescription release from the pharmacist, and the plan for concluding the medical assistance in dying process (i.e., return of any unused and partially used drugs). Planned Date and Time of Prescription Release - The pharmacist will discuss with the prescriber and record the planned date and time of release of the prescription(s). Plan for Concluding Medical Assistance in Dying Process - The pharmacist will indicate by checkmark that procedures have been established with the prescriber for the return of any unused and partially used medications within 48 hours to the pharmacy (for secure and timely disposal). Any pharmacist within the dispensing pharmacy may receive back unused and partially used medications from the prescriber. Prescription Accountability This section includes information on the Medication Administration Record, dispensing sign-off, and details pertaining to the return of any unused and partially used medications after medical assistance in dying. Medication Administration Record (MAR) – The pharmacist will indicate by checkmark that the prescribing medical or nurse practitioner (prescriber) has been instructed on how to complete the MAR for medical assistance in dying medications. (Upon completion of medical assistance in dying, the physician will provide a copy of the MAR to the pharmacist for reconciliation of the return of all unused and partially used medications.) Dispensing Sign-Off – The pharmacist will record their name, signature, CPBC license number, and the date, to indicate their dispensing of the prescription(s) directly to the prescriber. The prescriber will record their name, signature, CPSID number or CRNBC Prescriber number, and the date, to indicate their receipt of the prescription(s) directly from the pharmacist. If the prescriber is unknown to the pharmacist, the pharmacist will confirm and record the prescriber’s identity by means of photo identification. Return of All Unused and Partially Used Medications to Pharmacist for Disposal – The full pharmacist should ensure the appropriate return of any unused and partially used medications to the pharmacy for disposal. The prescriber will return all unused and partially used medications to the pharmacy within 48 hours of the patient’s death. Any pharmacist within the dispensing pharmacy may receive back unused and partially used medications from the prescriber. The prescriber will provide a copy of the medication administration record to the pharmacist for review and reconciliation of the medications returned. The pharmacist will record the name of each unused or partially used medication, and will document the form, strength and quantity of medication returned. The prescriber will record their name, CPSID number, signature and the date, to indicate their return of any unused and partially used medications. The pharmacist will record their name, CPBC license number, signature and the date, to indicate their receipt of any unused and partially used medications. The pharmacist will then provide a copy of the completed prescription sections (including the Prescription, and the “Prescription Planning” and “Prescription Accountability” sections) to the prescriber, since it is the responsibility of the prescriber to submit all completed forms for medical assistance in dying to the BC Coroners Service. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 7 Guidance on Completing Sections of the Prescription Medication Administration Record There is a separate medication administration record (MAR) for the intravenous drug protocol and for the oral drug protocol. Both MARs contain an identical first section to be completed by the prescribing medical or nurse practitioner (prescriber), on information about the patient (name, birthdate, personal health number) and prescriber (name, CPSID # or CRNBC prescriber #, signature, and initials). The second section of the MAR lists each drug in the order of administration for medical assistance in dying. The prescriber will record and initial for each medication the dose administered and the time given. The prescriber will provide a copy of the completed MAR to the pharmacist for review and reconciliation of the return of any unused and partially used medications. Acknowledgements: Thank you to the Nova Scotia College of Pharmacists for sharing their drug protocol documents and for their permission to adapt them, upon which the British Columbia protocols were based. This document was developed with the assistance and guidance of many individuals and organizations. Acknowledgement and thanks to the provincial Medical Assistance in Dying Pharmacy Sub-committee for their contributions and expertise, as well as to the following organizations: College of Pharmacists of BC British Columbia Regional Health Authorities College of Physicians and Surgeons of BC British Columbia Pharmacy Association College of Registered Nurses of BC Canadian Society of Hospital Pharmacists (BC Branch) In addition, we would like to acknowledge the jurisdictions of Alberta, Quebec, Oregon, and the Netherlands for the publication of their pharmacy protocol guidelines, which have significantly contributed to this work. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 8 Prescription Document Date: British Columbia Medical Assistance in Dying Prescription – SAMPLE (not for use) Upon completion of Medical Assistance in Dying (MAiD): 1) Prescriber to provide copy of completed MAR to Pharmacist for reconciling the return of unused and partially used medications in “Prescription Accountability” section of Prescription; 2) Pharmacist to provide copy of completed Prescription sections (including “Prescription Accountability”) to Prescriber; 3) Prescriber to fax completed Prescription (all sections, including Prescription Planning and Accountability sections and MAR) with all other MAiD forms to BC Coroners Service, Attention Deputy Chief Coroner, fax 604-660-7766; 4) For cases involving a health authority (HA), Prescriber to fax or mail an additional copy of Prescription (all sections) to applicable HA (see bottom of page 4 for HA fax numbers and mailing information); 5) Prescriber to retain a copy of Prescription (all sections) in patient’s health record. Identification and Declaration Patient Information Name: Birthdate (YYYY/MM/DD): Address: Personal Health Number: Medical Information (pertinent to medical assistance in dying allergies, etc.): Medical / Nurse Practitioner Information (Prescriber) Name: CPSID #: Address: CRNBC Prescriber #: Telephone Number: Signature: Medical / Nurse Practitioner Declaration (Prescriber) The Prescriber will initial each statement to declare it is true. The Pharmacist will initial the first statement to acknowledge discussion and confirmation with Prescriber. The intention is NOT that the Pharmacist performs an assessment of the patient’s eligibility criteria or obtains consent from the patient – these functions are to only be performed by the Prescriber. Prescriber Initials Pharmacist Initials I confirm the medications prescribed on this form are intended for the purpose of medical assistance in dying, and patient’s drug therapy has been discussed. I have determined the patient is capable to consent to medical assistance in dying. I have determined the patient is suffering from a grievous and irremediable medical condition and meets the eligibility criteria. I have received informed consent from the patient authorizing medical assistance in dying. Name of other Medical / Nurse Practitioner who confirms that the patient meets the eligibility criteria. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 9 Prescription Document Intravenous Drug Protocol – Administered by Medical / Nurse Practitioner Patient Name: Birthdate (YYYY/MM/DD): Personal Health Number: The following are the components of the Medical or Nurse Practitioner-Administered medical assistance in dying intravenous drug protocol. Initial to confirm the selected drug for each protocol component. Sign the form at the bottom to prescribe the selected medications. Indicate by checkmark whether IV Drug Regimen is: Primary IV Kit x 2 (Pharmacist must dispense 2 identical IV kits of all drugs in a sealed / tamperproof container.) or Back-up IV Kit for Oral Regimen Dispensed Quantity (Mitte) Drug Dosage Notes Prescriber Initials Anxiolytic (Initial to confirm anxiolytic is being ordered.) midazolam (1 mg/mL) 10 mg x 2 2.5 mg to 10 mg IV over 2 minutes. midazolam 1 mg/mL is preferred formulation. May repeat additional dose x 1 PRN. Local Anaesthetic lidocaine (20 mg/mL) 40 mg 40 mg IV over 30 seconds. lidocaine 20 mg/mL is preferred formulation. COMA Inducing Agent (CHOOSE one of the two alternatives. Initial to indicate selected agent.) proPOFol (10 mg/mL) 1gx1 1 g IV over 5 minutes. May repeat additional dose x 1 PRN. 1st line agent 3 g (dilute to 50 mL with sodium chloride 0.9%) IV over 5 minutes. May repeat additional dose x 1 PRN. 2nd line agent phenobarbital 120 mg/mL is preferred formulation. 200 mg by rapid IV injection. Confirm deep medically-induced coma before administration. OR 3gx1 phenobarbital (120 mg/mL) sodium chloride 0.9% 10 mL x 3 for injection (for dilution) Obtain additional PRN from back-up IV kit, if required. Neuromuscular Blocker rocuronium (10 mg/mL) 200 mg IV Line Flush Solution sodium chloride 0.9% solution 10 mL x 6 Flush IV line after each medication to ensure entire dose is given AND to avoid incompatibilities. Medical / Nurse Practitioner Signature (Prescriber) My signature serves to prescribe the medications initialed above for this patient. ________________________________ Signature _________________ Date BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 _____________ _______________ CPSID # or CRNBC Prescriber # 10 Prescription Document Oral Drug Protocol – Self-Administered (Supervised by Medical / Nurse Practitioner) Patient Name: Birthdate (YYYY/MM/DD): Personal Health Number: The following are the components of the Self-Administered medical assistance in dying oral drug protocol. Initial to confirm the selected drug(s) for each protocol component. Sign the form at the bottom to prescribe the selected medications. For controlled prescription drugs (e.g. morphine), provide an additional prescription written on a duplicate prescription form and attach to this form. Dispensed Prescriber Drug Dosage Notes Quantity (Mitte) Initials Gastric Motility / Anti-Emetic metoclopramide 20 mg (tablets) ondansetron 8 mg (tablet) haloperidol 5mg (5 mg/mL) 10 mg tablets x 2 20 mg (2 tablets) orally one hour prior to ingesting comainducing agent. 8 mg tablet x 1 8 mg (1 tablet) orally one hour prior to ingesting comainducing agent. 5 mg intravenous vials x 2 5 mg subcutaneous or IV over 1 minute PRN for emesis during procedure. May repeat additional dose x 1 PRN. Use haloperidol 5 mg/mL intravenous formulation Anxiolytic (Initial to confirm anxiolytic is being ordered.) LORazepam 0.5 mg (sublingual tablets) 0.5 mg sublingual tablets x 8 0.5 mg to 2 mg (1 to 4 tablets) sublingually, 5 to 10 minutes prior to ingesting coma-inducing agent, if needed for anxiety. May repeat additional dose x 1 PRN. COMA Inducing Agent (Initial to confirm each ingredient is being ordered.) Powder Mixture: phenobarbital powder* 20 g chloral hydrate powder* 20 g morphine sulphate powder** 3g *Active ingredients required for coma induction. [Note: Omit morphine if patient has significant morphine allergy (i.e. anaphylaxis)] ORA-Plus® / ® ORA-Sweet (50/50) or Distilled Water for feeding tube Shake well. Ingest the entire prescription in less than 4 minutes. **Optional, depending qs to 120 mL on patient factors (e.g., adverse effects, tolerance). Stable for 72 hours. Patient to follow with a small amount of nonfat, non-carbonated drink. If compound is to be administered via PEG or NG tube, replace “ORAPlus®/ORA Sweet®” with 120 mL of water. Flush feeding-tube with 60 to 90 mL of water after medication. Notes: 1) Prescriber must complete the Intravenous Drug Protocol section of the prescription form to prescribe the specific contents of the back-up IV kit. 2) Pharmacist must dispense 1 “po” kit plus 1 “IV” kit as backup in sealed / tamperproof container. The backup IV kit should include a second dispensed quantity of proPOFol or phenobarbital (i.e., total dispensed quantity of proPOFol 1 g x “2”, or phenobarbital 3g x “2”). Medical / Nurse Practitioner Signature (Prescriber) My signature serves to prescribe the medications initialed above for this patient. ________________________________ _________________ _____________ Signature Date CPSID # BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 _______________ or CRNBC Prescriber # 11 Prescription Document Prescription Planning Patient Name: Birthdate (YYYY/MM/DD): Personal Health Number: Planned Date and Time of Prescription Release and Return of Unused Medications Planned Release Date (YYYY/MM/DD): Planned Return Date (YYYY/MM/DD): Planned Release Time (00:00 am/pm): Planned Return Time (00:00 am/pm): Plan for Concluding Medical Assistance in Dying Process Procedures have been established for the return of any unused and partially used medication(s) within 48 hours to the Pharmacy for secure and timely disposal. Any Pharmacist within the dispensing pharmacy can receive back unused and partially used medications from the Prescriber. Completed Prescription Accountability Medication Administration Record The Prescriber has been instructed on how to complete the Medication Administration Record for medical assistance in dying medications. Completed Dispensing Sign-Off Printed Name Signature Dispensed by: College ID Date Time CPBC License #: (Pharmacist) Received by: CPSID # / CRNBC (Prescriber) Prescriber #: Completed Confirmation of photo ID of Prescriber, if applicable: Return of All Unused and Partially Used Medications to Pharmacist for Disposal The Prescriber will return all unused and partially used medications to the pharmacy within 48 hours of the patient’s death. The Pharmacist will reconcile and document the return of unused and partially used medication(s) below. Medication Name(s) Printed Name Form Strength Signature College ID Returned by: CPSID # / CRNBC (Prescriber) Prescriber #: Received by: CPBC License #: Quantity Date Time (Pharmacist) Health Authority fax numbers for submission of forms: FHA: Fax: 604-523-8855 NHA:– 1Fax: VIHA: Fax: 250-727-4335 (Please make 2 photocopies for 250-565-2640 Prescriber and 1 for Pharmacy records) IHA: Fax: 250-469-7066 VCHA: Fax: 1-888-865-2941 PHSA: Fax: 604-829-2631 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 For mailing addresses of Health Authorities, see Document Submission Checklist, HLTH 1632. http://www2.gov.bc.ca/assets/gov/health/forms/1632.pdf 12 Prescription Document Medication Administration Record (Provide copy of completed MAR to Pharmacist) Medical Assistance in Dying – Intravenous Drug Protocol (Administered by Medical / Nurse Practitioner) Date: Name of Patient: Birthdate (YYYY/MM/DD): PHN: Name of Medical / Nurse Practitioner (Prescriber): CPSID #: Signature: Initials: Drug Dose Administered CRNBC Prescriber #: Time Given Prescriber Initials Anxiolytic midazolam 2.5 to 10 mg IV over 2 minutes ***May repeat additional dose x 1 PRN*** sodium chloride 0.9% solution Flush line to ensure entire dose is given AND to avoid incompatibilities Anesthetic lidocaine 40 mg IV over 30 seconds sodium chloride 0.9% solution Flush line to ensure entire dose is given AND to avoid incompatibilities Coma-inducing Agent - Choose proPOFol OR phenobarbital proPOFol 1 g IV over 5 minutes ***May repeat additional dose x 1 PRN*** phenobarbital 3 g (dilute to 50 mL with sodium chloride 0.9%) IV over 5 minutes ***May repeat additional dose x 1 PRN*** sodium chloride 0.9% solution Flush line to ensure entire dose is given AND to avoid incompatibilities Neuromuscular Blocker – Confirm patient is in deep medically-induced coma* prior to administration rocuronium 200 mg by rapid IV injection sodium chloride 0.9% solution Flush line to ensure entire dose is given AND to avoid incompatibilities * Deep medically-induced coma: No response to verbal stimuli, unable to rouse; serious depression of circulation, evidenced by weak pulse; serious depression of ventilation, evidenced by slow, shallow breathing; no protective reflexes, such as eyelash reflex. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 13 Prescription Document Medication Administration Record (Provide copy of completed MAR to Pharmacist) Medical Assistance in Dying – Oral Drug Protocol (Supervised by Medical / Nurse Practitioner) Date: Name of Patient: Birthdate (YYYY/MM/DD): PHN: Name of Medical / Nurse Practitioner (Prescriber): CPSID #: Signature: Initials: Drug Dose Administered CRNBC Prescriber #: Time Given Prescriber Initials Anti-emetic (prior to procedure) metoclopramide 20 mg (10 mg tablets x 2) 1 hour prior to the coma-inducing agent ondansetron 8 mg (1 tablet) 1 hour prior to coma-inducing agent Anxiolytic LORazepam 0.5 mg sublingual tablets 0.5 to 2 mg (1 to 4 tablets), 5 to 10 minutes prior to coma-inducing agent, as needed for anxiety ***May repeat additional dose x 1 PRN*** Coma-inducing Agent phenobarbital powder 20 g chloral hydrate powder 20 g morphine sulphate powder 3 g (cross-out morphine, if not given) ***Shake well. *** Ingest entire mixture in less than 4 minutes, followed by a glass of water or non-carbonated, non-fat liquid of patient’s choice. For PEG or NG tube administration, flush feeding-tube with 60 to 90 mL of water after medication. Anti-emetic (during procedure) haloperidol 5 mg SUBCUT or IV over 1 minute as needed for emesis ***May repeat additional dose x 1 PRN*** BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 14 Drug Protocol Monographs Medical Assistance in Dying Drug Protocol Monographs WARNING: These drug monographs were prepared for use with the Standardized Pharmacy 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 and the intended use of the preparations, shortened beyond use dates are assigned in these monographs to ensure the medications are used promptly. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 15 Intravenous Drug Protocol Monographs Intravenous Drug Protocol Monographs (drugs are listed in order of administration in the protocol) Please Note: To prevent IV incompatibilities, stop all other infusions and flush the IV line with 10 mL Normal Saline (sodium chloride 0.9%) before proceeding. Preamble Vascular access Vascular access should be established in ALL patients, regardless of whether the intravenous or the oral regimen is selected. In cases where patients are unable to tolerate the oral medications or the regimen is ineffective, the provider will have the option of administering the medications intravenously. If there are issues with venous access, a central line may be required. Other medications and treatments Routine analgesic therapies should be continued right up to the time of the procedure. Oxygen therapy should be discontinued at the beginning of the procedure to avoid prolonging apnea and delaying cardiac arrest. Defibrillator must be deactivated before procedure. 1. Anxiolytic Drug midazolam 1 mg/mL Benzodiazepine used for reducing anxiety around the procedure. 1 mg/mL strength is recommended for ease of administration and delivery of accurate dose. Dose Administer 2.5 to 10 mg (2.5 to 10 mL) IV over 2 minutes; May repeat additional dose of 2.5 to 10mg IV (2.5 to 10 mL), if required. Onset of effect: 1 to 5 minutes.1 Peak effect: 5 to 7 minutes1 (reassess need for additional dose 10 minutes after delivery of initial dose). Adjust dose according to patient-specific factors. Patients exposed to prior benzodiazepines may require a higher dose. Frail, elderly, and/or benzodiazepine-naïve patients may require lower doses. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 16 Intravenous Drug Protocol Monographs Preparation Draw up 2 syringes of 10 mg (10 mL), each into a 20 mL syringe. Protect prepared syringes from light2 – store in amber bag. Beyond Use Date3/Stable in a polypropylene syringe at room temperature (RT) for 48 hours when prepared in a laminar flow hood; or 24 hours when prepared on a countertop.4,5 Administration Give IV direct over 2 minutes. Compatible5 with fentanyl, HYDROmorphone, LORazepam, morphine. For additional compatibility information, consult pharmacy. Flush with normal saline to ensure all the dose is delivered. Monitoring Monitor for anxiety, level of consciousness, and need for repeat dose. Patient may remain awake or may lose consciousness, depending on their sensitivity to benzodiazepines. Paradoxical agitation may occur in some patients; coma should then be induced without delay and no further midazolam given. Counseling for Patient and Family This medication reduces anxiety and helps the patient relax. Advise that the patient may or may not lose consciousness. 2. Anesthetic Drug lidocaine 20 mg/mL Lidocaine is a local anesthetic used to decrease the pain on administration of subsequent medications. Do NOT administer lidocaine WITH epinephrine IV. Do NOT use if history of true allergy to lidocaine or other amide-type local anaesthetics (e.g. bupivacaine, prilocaine, mepivacaine). Dose Administer 40 mg (2 mL) IV over 30 seconds. Onset of effect: 45 to 90 seconds.1 Peak effect: unknown, but duration of action is 10-20 minutes.1 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 17 Intravenous Drug Protocol Monographs Preparation Draw up 40 mg (2 mL) into a 3 mL syringe. Beyond Use Date/Stable in a polypropylene syringe at RT for 48 hours or 14 days refrigerated when prepared in a laminar flow hood; or 24 hours at RT or 72 hours refrigerated, when prepared on a countertop.3-5 Administration Give IV direct over 30 seconds. Compatible with fentanyl, HYDROmorphone, LORazepam, morphine.3 For additional compatibility information, consult pharmacy. Flush with normal saline to ensure all the dose is delivered. Monitoring High levels of lidocaine can cause ringing in the ears, numbness of the lips, metallic taste, nausea, and dizziness; adverse effects should subside rapidly once drug levels fall Check for level of comfort at IV site. Counseling for Patient and Family This medication helps numb the veins and the area around the IV site, so administration of the next medication is more comfortable. Advise the patient that they may experience ringing in the ears, numbness around the lips, metallic taste, nausea or dizziness, but these effects (if any) would pass quickly. 3. Coma-inducing Agent Drug proPOFol 10 mg/Ml proPOFol is used to induce a coma state that is deep enough to prevent the patient from feeling the effects of the neuromuscular blocker. proPOFol is the preferred coma-inducing agent due to ease of preparation. proPOFol may contain egg and soy proteins, and may be contraindicated in patients with severe allergies to those components (various brands of the product may contain different components).6 If proPOFol is contraindicated, phenobarbital is the alternative. Dose Administer 1g (100 mL) IV over 5 minutes; May repeat additional 1g (100 mL) IV over 5 minutes x 1, if required. Onset of effect: 30 seconds.1 Peak effect: duration of action is 3 to 5 minutes at usual doses; duration of effect at this higher dose is unknown.1 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 18 Intravenous Drug Protocol Monographs Preparation Draw up & prepare four syringes: 250 mg (25 mL) into each 30 mL syringe. Use a vented dispensing pin (if available) to puncture the vial and draw up the proPOFol into each syringe; this will reduce the pressure in the vial, allowing for easier withdrawal of the medication. Beyond Use Date/Stable in a polypropylene syringe at RT for 48 hours or 14 days refrigerated, when prepared in a laminar flow hood; or 24 hours at RT or 72 hours refrigerated, when prepared on a countertop.3-5 Administration Give IV direct over 5 minutes (each 50 mL syringe given over 2.5 minutes). Compatible with fentanyl, SUFentanyl, HYDROmorphone; variable compatibility with morphine (high concentrations may affect emulsion stability).5 For additional compatibility information, consult pharmacy. Rapid bolus administration may result in loss of venous access; while injecting too slowly may reduce the effectiveness of the medication and compromise development of coma. Observe for pain during injection. Ensure neuromuscular blocker is available and ready to be immediately administered after proPOFol administration. Flush with normal saline to ensure all the dose is delivered. Monitoring Monitor for level of consciousness and onset of medically-induced deep coma. - A patient is in a medically-induced deep coma if the following signs are present7: o No response to verbal stimuli; unable to rouse o Severe circulation depression, evidenced by weak pulse o Severe respiratory depression, evidenced by slow, shallow breathing o No protective reflexes, such as the eyelash reflex - The Richmond Agitation and Sedation (RASS) Scale is a reliable and validated tool developed to titrate sedative medications in critical care settings that can be used as a monitoring tool.8 The target for medically-induced deep coma is “-5” on the scale, which corresponds to lack of response to voice or physical stimulation. (The RASS Scale is provided as an addendum at the end of this drug monograph.) - Consider an additional proPOFol dose only if medically-induced deep coma is not achieved with one dose, although the likelihood of inadequate loss of consciousness is low with the recommended doses.9 - Neuromuscular blocker should only be administered once patient is in a medicallyinduced deep coma.9 - Cardiopulmonary arrest may occur rapidly during administration of the comainducing agent. Those present at the procedure should be advised of this. Even when cardiopulmonary arrest does occur during coma induction, the neuromuscular blocker must ALWAYS be administered to prevent any doubt as to the patient’s death.9 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 19 Intravenous Drug Protocol Monographs Counseling for Patient and Family This medication will place the patient in a deep coma-like state. Advise the patient that they will lose consciousness, and breathing may slow significantly or stop altogether. The physician will ensure that the patient is in a medically-induced deep coma before administering the next medication. Drug phenobarbital 120 mg/mL phenobaribital is a barbiturate used to induce coma state that is deep enough to prevent the patient from feeling the effects of the neuromuscular blocker. proPOFol is the preferred coma-inducing agent; phenobarbital is an alternate agent only if proPOFol is contraindicated. Dose Administer 3g IV over 5 minutes; May repeat additional 3g IV over 5 minutes x 1, if required. Onset of effect: 5 minutes.1 Peak effect: >15 minutes for CNS depression.1 Preparation Withdraw 3000 mg (25 mL) into a 60 mL syringe and further dilute with normal saline to total volume of 50 mL. Preparation of phenobarbital syringe requires 25 x 1 mL ampoules. Use an ampoule breaker device to open each ampoule. Use a filter needle when withdrawing medication from the glass ampoule (only when a filter disc is not available). Prior to administration, attach a filter disc (if available) to the syringe and administer the phenobarbital; the filter disc will prevent any potential glass particles from being injected. Beyond Use Date/Stable in a polypropylene syringe at RT for 48 hours when prepared in a laminar flow hood, or 24 hours when prepared on a countertop. Store at controlled room temperature and protect from light in an amber bag. Limit exposure of solution to air.3-5 Administration Give IV direct over 5 minutes. Compatible with fentaNYL, variable compatibility (concentration-dependent)with HYDROmorphone, methadone, morphine, proPOFol, SUFentanil.5 For additional compatibility information, consult pharmacy. Rapid bolus administration may result in loss of venous access; while injecting too slowly may reduce the effectiveness of the medication and compromise development of coma. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 20 Intravenous Drug Protocol Monographs Observe for pain during injection. Ensure neuromuscular blocker is available and ready to be immediately administered after phenobarbital administration. Flush with normal saline to ensure full dose is delivered into vein. Monitoring Monitor for level of consciousness and onset of medically-induced deep coma. A patient is in a medically-induced deep coma if the following signs are present7: o No response to verbal stimuli; unable to rouse o Severe circulation depression, evidenced by weak pulse o Severe respiratory depression, evidenced by slow, shallow breathing o No protective reflexes, such as eyelash reflex The Richmond Agitation and Sedation (RASS) Scale is a reliable and validated tool developed to titrate sedative medications in critical care settings that can be used as a monitoring tool.11 The target for medically-induced deep coma is “-5” on the scale, which corresponds to lack of response to voice or physical stimulation. (The RASS Scale is provided as an addendum at the end of this drug monograph.) Consider an additional phenobarbital dose only if medical-induced coma is not achieved with one dose, although the likelihood of inadequate loss of consciousness is low with the recommended doses.11 Neuromuscular blocker should only be administered once patient is in a medicallyinduced deep coma.9 Cardiopulmonary arrest may occur rapidly during administration of the coma-inducing agent. Those present at the procedure should be advised of this. Even when cardiopulmonary arrest occurs during coma induction, the neuromuscular blocker must ALWAYS be injected to prevent any doubt as to the patient’s death.9 Counseling for Patient and Family This medication will place the patient in a deep coma-like state. Advise the patient that they will lose consciousness, and breathing may slow significantly or stop altogether. The physician will ensure that the patient is in a medically-induced deep coma before administering the next medication. 4. Neuromuscular Blocker Drug rocuronium 10 mg/mL Rocuronium is a neuromuscular blocker used to cause skeletal muscle relaxation, resulting in respiratory arrest. Neuromuscular blockade causes paralysis of skeletal muscles (including the diaphragm) within minutes. Resulting respiratory arrest leads to death by anoxia; death may occur quickly after neuromuscular injection, if not already during coma induction.9 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 21 Intravenous Drug Protocol Monographs Dose Administer 200 mg (20 mL) IV by rapid injection Onset of action: 1 to 2 minutes; maximum neuromuscular blockade within 4 minutes1 Peak effect: unknown; duration is 30 minutes (with standard doses, increases with higher doses).1 Preparation Withdraw 200 mg (20 mL) into a 30 mL syringe. Beyond Use Date/Stable in a polypropylene syringe at RT for 24 hours regardless of site of preparation.3,5 Administration Give IV direct by rapid injection. Compatible with fentanyl, HYDROmorphone, midazolam, morphine, ondansetron, phenobarbital, REMifentanil, SUFentanil.10 For additional compatibility information, consult pharmacy. Flush with normal saline to ensure full dose is delivered into vein. Monitoring Confirm that the medically-induced deep coma is “-5” on the Richmond Agitation and Sedation Scale) prior to administration of the neuromuscular blocker.9 Respiratory arrest generally occurs before cardiac arrest; delays of up to 20 minutes between respiratory arrest and cardiac arrest may occur.11 Assess for signs of death, including cessation of respirations, heart sounds, pulses, response to tactile stimuli and pupil response. Counseling for Patients and Family This medication will slow down and stop the patient’s breathing Advise those present, before starting the injections, that death may occur relatively quickly and the heart may continue to beat for a short period after breathing has stopped.9,11 The physician is required to perform a physical assessment of the patient to confirm death. 1 Lexicomp Online®, Hudson, Ohio: Lexi-Comp, inc.: August 5, 2015. th Bing, CM. Extended Sterility for Parenteral Drugs, 5 ed. 2013:p.248. 3 “Beyond Use Date” or BUD is defined as the maximum time that you can store a syringe before it is used. It takes into account both chemical stability and sterility concerns. When there is no supporting stability or sterility testing data BUD is based on USP <797> guidelines which are the standards for sterile and non-sterile compounding. 4 USP 31-NF 26 Revisions Bulletin, <797> Pharmaceutical Compounding-Sterile Preparation: 2012. 5 th Handbook of Injectable Drugs™, 18 ed. 2015. (Stat!Ref online). American Society of Health-System Pharmacists. Bethesda, Maryland. Accessed October 7, 2016. 6 Diprivan [Product Monograph], Mississauga, ON: AstraZeneca Canada, Inc.; July 30, 2012. 7 KNMG/KNMP: Guidelines for the Practice of Euthanasia and Physician-Assisted Suicide 2012. Royal Dutch Medical Association/Royal Dutch Pharmacists Association, The Hague, Netherlands. 8 Sessler CN, Gosnell MS, Grap MJ, et al. The Richmond Agitation-Sedation Scale; Validity and Reliability in Adult Intensive Care Unit Patients. Am J Resp Crit Care Med 2002;166(10); 1338-1334. 9 Medical Aid in Dying: 11/2015 Practice Guidelines. Collège des mèdecins du Quèbec:; Ordre des pharmaciens du Quèbec; Ordre des infirmières et infirmiers du Quèbec, November 2015. Bibliothèque et Archives nationales du Quèbec; Library and Archives Canada. 10 th Davis’s Drug Guide For Nurses, 15 ed. 2015. F.A. Davis Company, Philadephia, PA. 11 Medical Assistance in Dying (MAID) Pharmacy Protocols, June 22, 2016. Alberta Health Services. 2 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 22 Intravenous Drug Protocol Monographs Addendum to the Intravenous Drug Protocol Monographs 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 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 23 Oral Drug Protocol Monographs Oral Drug Protocol Monographs (drugs are listed in order of administration in the protocol) Preamble Patients may choose to take oral medications for medical assistance in dying, rather than receive the intravenous drug protocol. The prescribing physician or nurse practitioner (prescriber) must personally attend the patient during self-administration of the oral drug protocol and must remain in attendance until death is confirmed.1 The intravenous route is the recommended option, due to its more rapid onset of activity and reduced incidence of complications. Intravenous access must also be established when the oral route is utilized, so that the intravenous regimen can be administered as a standby option in the event the oral regimen is ineffective. The prescriber and patient should agree on a pre-determined maximum period of time to allow for the oral regimen to take effect, before deeming it unsuccessful and moving forward with the administration of the back-up intravenous drug protocol. The prescriber will record whether the back-up intravenous kit was administered, as well as the number of hours after ineffective self-administration, on the Assessment Record (Prescriber) form (in the section “Administration of Medical Assistance in Dying”).2 Note: Based on data from Oregon, the median time between ingestion and unconsciousness is approximately 5 minutes (range 1-38 minutes) and the median time between ingestion and death is 25 minutes (range 1- 48 minutes).3 The patient must be capable of swallowing sufficient volumes of liquids (120 mL). Relative contraindications to the oral procedure include severe nausea, dehydration, esophagitis or gastritis, and/or any significant gastrointestinal transit disorders that would interfere with absorption. Where possible, the patient should not eat or drink 4 to 5 hours prior to the procedure to improve the rate of absorption and decrease the risk of regurgitation or vomiting. Administration of anti-emetics beforehand is recommended to minimize the likelihood of the patient vomiting, as the mixture’s taste is bitter and may be unpleasant. Many patients receive opioids at the end of their lives, which can slow gastrointestinal transit time and result in longer absorption and distribution time that can delay the effect of the oral regimen. 1a. Anti-emetic / Gastric Motility (Nausea Prevention) Drug metoclopramide 10 mg tablet Blocks dopamine and serotonin receptors to prevent and treat nausea and vomiting, and enhances gastric emptying and gastrointestinal motility.4 If patients are already on medications to control nausea and/or vomiting, these should be continued right to the start of the procedure. Contraindicated in hypersensitivity to metoclopramide, gastrointestinal hemorrhage, mechanical obstruction, perforation, parkinson’s disease, history of seizures, or pheochromocytoma (due to potential for precipitating hypertensive crisis). BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 24 Oral Drug Protocol Monographs Dose/route Take 20 mg orally 1 hour prior to procedure. Note: For patients with history of nausea, may consider 10 to 20 mg PO TID starting 24 hours prior to procedure. Onset of effect: 30 to 60 minutes5 Peak effect: 1 to 2 hours5 Preparation Supplied as metoclopramide tablets 10 mg x 2. Monitoring May cause drowsiness, confusion, and/or extrapyramidal symptoms such as tremors, restlessness and dystonia.5 While the risk of adverse effects with a single dose is low, the effects may be additive if patients are frail, elderly, or on other medications that have similar effects. Counseling Patient and Family Inform patient that the medication will assist in preventing symptoms of nausea and vomiting. 1b. Anti-emetic (Nausea Prevention) Drug ondansetron 8 mg tablet Selective 5-HT3-receptor antagonist that blocks serotonin to prevent and treat severe nausea and vomiting.5 Ondansetron is used together with metoclopramide to prevent nausea and vomiting, but it lacks the pro-motility effects of metoclopramide. Contraindicated in patients with hypersensitivity to ondansetron or in concomitant use of apomorphine. Caution when given with other serotonin agents, due to the risk of serotonin syndrome. Dose/route Take 8 mg orally 1 hour prior to procedure. Onset of effect: approximately 30 minutes5 Peak effect: 1 to 2 hours5 Preparation Supplied as ondansetron tablet 8 mg x 1. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 25 Oral Drug Protocol Monographs Monitoring May cause headache, fatigue, drowsiness; serotonin syndrome (agitation, tachycardia, flushing, tremor, rigidity).5 While the risk of adverse effects with a single dose is low, the effects may be additive if patients are frail, elderly, or on other medications that have similar effects. Counseling Patient and Family Inform patient that the medication will assist in preventing symptoms of nausea and vomiting. 2. Anxiolytic Drug LORazepam 0.5 mg sublingual tablets Benzodiazepine that reduces anxiety symptoms. Contraindicated in hypersensitivity to benzodiazepines or history of paradoxical reactions to benzodiazepines. Dose/route Take 0.5 to 2.0 mg sublingually or orally 5 to 10 minutes prior to procedure, if needed for anxiety. May give additional dose, if required. Note: Avoid over-sedating patient, as this can impair their ability to swallow the oral comainducing compound. For benzodiazepine-naïve or debilitated patients, 0.25 mg is recommended. Onset of effect: unknown1 Peak effect: 1 hour1 Preparation Supplied as lorazepam sublingual tablets 0.5 mg x 8 Monitoring May cause drowsiness, dizziness, and/or paradoxical agitation especially in frail and/or benzodiazepine naïve patients.5 Observe for alleviation of anxiety, comfort and readiness to proceed with the procedure. Counseling Patient and Family Inform patient that this medication will help relieve anxiety around the procedure and help the patient relax. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 26 Oral Drug Protocol Monographs 3. Coma-Inducing Agent The coma-inducing agent is a combination of phenobarbital (a barbiturate) and chloral hydrate (a sedative), plus or minus morphine (an opioid), in an oral suspension. The recommended regimen is to include all three medications (phenobarbital, chloral hydrate, and morphine). The regimen MUST at least contain phenobarbital and chloral hydrate powders, as ingredients. Morphine may be omitted if the patient has a significant morphine allergy (anaphylaxis), has experienced a severe adverse reaction to morphine (neurotoxicity), or is already taking significant doses of opioid medications.5 Drugs (Components of the Oral Suspension) phenobarbital - a barbiturate used to induce a coma-like sedative state. chloral hydrate - a general CNS depressant that also depresses cardiac o Onset of effect: 5 minutes5 o Peak effect: 15 minutes or greater for CNS depression5 contractibility, and has sedative and anti-anxiety effects. o Onset of effect: 10 to 20 minutes5 o Peak effect (time to sedation/loss of consciousness): 30 to 60 minutes5 Note: Chloral hydrate is a gastric irritant, and may cause pain and discomfort for patients who have mouth ulcers, esophagitis or gastritis.5 This irritant property may be a relative contraindication to using the oral route. However, if the patient still prefers using the oral route, pre-treatment with a local anesthetic product such as lidocaine endotracheal spray, lidocaine viscous or benzocaine spray may be considered. morphine - an opioid agonist which is also a generalized CNS depressant and an analgesic. o Onset of effect: variable, but generally 30 minutes for oral route5 o Duration of effect: 3 hours at usual doses5 Preparation/Storage/Stability Please refer to compounding formulation sheet for information on how to prepare the suspension. Store at room temperature Stable for 72 hours at room temperature6 Administration The patient must be sitting upright and in bed when they take the suspension - this would prevent the situation in which they are unable to make it back to bed in time. Alternatively, the oral suspension may be administered via a feeding tube. The tube must be flushed post-administration with 60 to 90 mL of water. Shake well prior to administration; mixing of contents may need to be repeated if patient takes a long period of time to consume the suspension. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 27 Oral Drug Protocol Monographs It is ideal to ingest the entire dose within 4 minutes, before the patient becomes extremely drowsy or unconscious; the risk of a failed procedure or a prolonged dying period increases if the patient is unable to take the full amount. Do not allow the patient to consume the drink through a straw, as this will generally take longer, and may increase the risk of the medications taking effect before the whole dose is consumed.7 Because this mixture is bitter and can cause a burning sensation, a room temperature non-fat liquid such as non-carbonated soda, fruit juice, liquor of patient’s preference, or water should be taken after ingestion. Monitoring The period of time between administration and time of death varies from person-toperson, but in a vast majority of cases, unconsciousness occurs within 5 minutes and death within 30 minutes. Monitor closely for signs of nausea, reflux, regurgitation, and vomiting. Assess for signs of death, including cessation of respirations, heart sounds, pulses, response to tactile stimuli and pupil response. Counseling Patient and Family This medication will cause the patient to first lose consciousness and then their breathing may slow down significantly or stop; it is normal for the heart to continue to beat for a while after the breathing has stopped. The effect of the medication may take anywhere from a few minutes to a few hours to work. Most people will be unconscious within 5 minutes and pass away in less than 30 minutes. Since the time of onset of death is unpredictable, the prescriber and patient should agree on a pre-determined maximum period of time to allow for the oral regimen to take effect. If the maximum period of time is reached and the oral drug protocol is deemed unsuccessful, administration of the back-up intravenous drug protocol would then proceed. The physician is required to perform a physical assessment of the patient to confirm death. 4. Anti-emetic (Nausea and Vomiting Treatment) Drug haloperidol 5 mg/mL Butyrophenone used to treat severe nausea and vomiting. Contraindicated in documented hypersensitivity to haloperidol or at high risk of extrapyramidal reactions. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 28 Oral Drug Protocol Monographs Dose/route Administer 5 mg (1 mL) subcutaneously, or IV over 1 minute, as needed for nausea and vomiting; May give additional 5 mg subcutaneously or IV dose x 1, if required. Onset of effect: unknown5 Peak effect: unknown5 Preparation Withdraw 5 mg (1 mL) into a 3 mL syringe. Beyond use date/Stable for48 hours at RT when prepared in a laminar flow hood or 24 hours at RT when prepared on a countertop.8,9 Protect from light and store at controlled room temperature.10 Administration Give subcutaneously or IV direct. Compatible with fentanyl, HYDROmorphone, lidocaine, methadone, midazolam, morphine, ondansetron, proPOFol, SUFentanil.5,10 For additional compatibility information contact pharmacy. Flush with normal saline to ensure full dose is delivered into vein. Monitoring Observe for alleviation of nausea and vomiting. Counseling Patient and Family Inform patient the medication will assist in stopping symptoms of nausea and vomiting. 1 Professional Standards and Guidelines- Medical Assistance in Dying. June 23, 2016(revised September 9, 2016). College of Physicians and Surgeons of British Columbia. Accessed Oct 10, 2016 at http:/www.cpsbc.ca/file/pdf/PSG-Medical-Assistance-inDying.pdf. 2 British Columbia Medical Assistance in Dying form: Assessment Record (Prescriber). 3 Dunn P, Reagen B (co-editors). The Oregon Death With Dignity Act: A Guidebook for Health Care Professionals. 2008. 4 Lexicomp Online®, Hudson, Ohio: Lexi-Comp, Inc. August 5, 2015. Accessed October 15, 2016. 5 Swarte NB. Guidelines for an acceptable euthanasia procedure. Best Pract Res Clin Obstet Gynaecol 2001;15(2):313-21. 6 USP –Revision Bulletin, <795> Pharmaceutical Compounding-Non-sterile Preparations. January 1, 2014. 7 KNMG/KNMP Guidelines for the Practice of Euthanasia and Physician-Assisted Suicide. August 2012. 8 “Beyond Use Date” or BUD is defined as maximum time that you can store a syringe before it is used. It takes into account both chemical stability and sterility concerns. When there is no supporting stability or sterility testing data BUD is based on USP<797> guidelines which are the standards for sterile and non-sterile compounding. 9 USP 31-NF 26 Revisions Bulletin, <797> Pharmaceutical Compounding-Sterile Preparation: 2012. 10 th Trissel, LA. Trissel’s stability of compounded formulations, 5 ed. 2012. American Pharmacists Association. Washington, DC. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 29 Suggested Compounding Procedure Suggested Compounding Procedure (Oral Coma-Inducing Suspension) Medical Assistance in Dying PREPARATION: Oral Coma-Inducing Compounded Suspension INDICATIONS: Medical Assistance in Dying - for oral self-administration INGREDIENTS: phenobarbital powder USP chloral hydrate powder USP morphine sulfate powder USP Ora-Plus®/ORA-Sweet® 50/50 OR if to be given by enteral tube use: Distilled water 20 g 20 g 3 g (if required) qs to 120 mL (suspending agent) qs to 120 mL EQUIPMENT: Enclosed weighing scale - if possible Mortar and pestle Conical graduate- 180 mL Stirring rod 250 mL amber glass bottle Preparation: 1. Prepare the compound in an area designated for compounding of prescriptions that is clean and uncluttered. 1 2. Assemble ingredients and equipment required for compounding. 3. Personal preparation – Wash hands and don personal protection items including a clean gown, powder-free gloves, mask, beard guard (if necessary) and eye protection. Procedure: 1. Weigh the powders within the enclosed scale and transfer into the mortar and pestle. 2. Triturate the powders well. Filter through a sieve into a large conical graduate. 3. Slowly add the suspending liquid to the powders mixing gently to avoid aerosolizing the powders and qs to 120 mL. 4. Transfer suspension to a 250 mL amber GLASS bottle for dispensing. 5. While USP <795> standards would allow a 7 day beyond use date (BUD) at room temperature, it is suggested to give it a 72 hour expiry date to ensure prompt use of the suspension. 6. Apply patient – specific label. 7. Labels with SHAKE WELL and WARNING: Contains LETHAL DOSE SHAKE WELL WARNING: Contains LETHAL 8. Decontaminate the compounding area after the procedure is complete. DOSE EXPIRY DATE: 7 day beyond use date at room temperature Expires: 72 hours from time of dispensing REFERENCE: (Adapted from P-C-M Suspension Formulation, Union Avenue Compounding Pharmacy, Tacoma WA) 1 US Pharmacopeia Convention (USP) General Chapter <795> pharmaceutical compounding - non-sterile preparations. USPO 39. Rockville, MD: USP; 2016. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 30 Suggested Pharmacy Inventory Lists Suggested Pharmacy Inventory Lists (Per Kit) for IV and Oral Regimens Medical Assistance in Dying Inventory List (Per Kit)– IV Regimen Quantity 2 2 2 2 1 Drug/Equipment midazolam 1 mg/mL (10 mL vial) 20 mL syringe 18G needle syringe label (for identifying medication and sequence) 5x8 plastic bag 1 1 1 1 1 lidocaine 2% (20 mg/mL) (5 mL polyamp) 3 mL syringe 18G needle syringe label (for identifying medication and sequence) 5x8 plastic bag 1 4 4 1 4 1 proPOFol 10 mg/mL (100 mL vial) 30 mL syringe 18G needle (if required) Vented dispensing pin (if available) syringe label (for identifying medication and sequence) 10x10 plastic bag 25 1 1 1 1 1 1 phenobarbital 120 mg/mL (1 mL glass ampoule) sodium chloride 0.9% (10 mL vial x 3) 60 mL syringe 18G needle Ampoule breaker device Filter disc (5 microns) syringe label (for identifying medication and sequence) 6x10 plastic bag 4 1 1 1 1 rocuronium 10 mg/mL (5 mL vial) 30 mL syringe 18G needle syringe label (for identifying medication and sequence) 5x8 plastic bag 4 1 sodium chloride 0.9% (10 mL pre-filled syringes x 4) 6x10 plastic bag 6 1 alcohol swab 5x8 plastic bag 3 BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 Initials 31 Suggested Pharmacy Inventory Lists Medical Assistance in Dying Inventory List (Per Kit) – Oral Regimen Quantity 2 1 2 Drug/Equipment metoclopramide 10 mg tablet ondansetron 8 mg tablet 4x4 plastic bag 2 2 2 2 2 2 1 haloperidol 5 mg/mL IV (1 mL vial) 3 mL syringe 18G needle 25G needle (for SC administration) alcohol pad syringe label (for identifying medication and sequence) 5x8 plastic bag 8 1 LORazepam 0.5 mg SL tablet 4x4 plastic bag Initials Compounded Oral Suspension – 120 mL 20 g 20 g 3g phenobarbital powder chloral hydrate powder morphine sulphate powder (if required) ORA-Plus® / ORA-Sweet (50/50) qs to 120 mL Distilled water 1 250 mL glass amber bottle BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 32 Suggested Inventory List for IV Insertion Equipment and Additional Supplies Suggested Inventory List for IV Insertion Equipment and Additional Supplies Required by Practitioner for Medication Administration Medical Assistance in Dying Inventory List (Per Kit) – IV Regimen Quantity 2 2 2 2 2 2 Equipment Blue pad 20 gauge IV cannula 22 gauge IV cannula 24 gauge IV cannula IV extension set with positive pressure cap Securement dressing (e.g., IV StatLock®, 3M™ Tegaderm™ I.V. Advanced) 2 of each 2 6-10 4 1 4 4 1 roll 1 Gloves – large, medium and small Tourniquet Alcohol swab Chlorhexidine with alcohol swabs Local anesthetic cream (e.g., Emla™) Transparent film dressing (e.g., Tegaderm™) 2x2 gauze Tape Scissors 8 1 5 5 2-10 Sodium chloride 0.9% 10 mL pre-filled syringe Sodium chloride 0.9% 50 mL minibag* 10 mL syringe (for sodium chloride)* Blunt fill needle* Syringe caps 1 1 Initials Garbage bag (small paper bedside one, hospital type) Small sharps container Additional Supplies required by Practitioner for Medication Administration (Per Kit) – IV Regimen Quantity Syringes 1 5 2 1 Needles 9 Accessories 1 1 Equipment Initials 60 mL syringe 30 mL syringe 20 mL syringe 3 mL syringe 18G needle Vented dispensing pin (for proPOFol only) – if available Ampoule breaker (for phenobarbital IV only) BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 33 Suggested Inventory List for IV Insertion Equipment and Additional Supplies 1 9 1 2 4 Filter disc (5 microns) (for phenobarbital IV only) – if available syringe label (for identifying medication and sequence) 10x10 plastic bag 6x10 plastic bag 5x8 plastic bag Additional Supplies required by Practitioner for Medication Administration (Per Kit) – Oral Regimen Quantity Equipment Syringes 2 3 mL syringe Needles 2 18G needle 2 25G needle (for SC administration) Accessories 2 Alcohol pad 2 syringe label (for identifying medication and sequence) 1 5x8 plastic bag 3 4x4 plastic bag * If prefilled sodium chloride 0.9% syringes are not provided. BC Pharmacy Protocols for Medical Assistance in Dying, 2016 12 05 Initials 34