TEMPORARY REGULATORY EXEMPTIONS CONCLUSION REFERENCES Institute for Safe Medication Practices Canada A KEY PARTNER IN Assess Pharmacy Infrastructure and Processes for DURING THE PANDEMIC REPORT MEDICATION INCIDENTS Providing Delivery Services Online: www.ismp-canada.org/err_index.htm Temporary legislative exemptions have been enacted 1. Subsection 56(1) class exemption for patients, practitioners Phone: 1-866-544-7672 Health Canada’s temporary exemptions to the • Review existing delivery services to ensure during the pandemic to ensure that patients receive an and pharmacists prescribing and providing controlled substances in Canada during the coronavirus pandemic. Controlled Drugs and Substances Act allow pharma- compliance with provincial/territorial uninterrupted supply of controlled substances, Ottawa (ON): Health Canada; 2020 Mar 19 [updated 2020 cists to authorize an individual (e.g., pharmacy requirements. If your own pharmacy is unable to including OAT, with maintenance of physical Apr 21; cited 2020 Apr 24]. Available from: employee) to deliver prescriptions containing deliver OAT as often as the patient requires, work distancing. There are several ongoing research https://www.canada.ca/en/health-canada/services/health- controlled drugs, such as OAT, to patients’ homes or with the patient to identify a pharmacy that can initiatives studying the impact of the pandemic on concerns/controlled-substances-precursor-chemicals/policy- regulations/policy-documents/section-56-1-class-exemption- to other locations where patients are self-isolating.1 reliably provide safe delivery of the medication, care of patients with opioid use disorder, recognizing Volume 20 • Issue 6 • June 9, 2020 patients-pharmacists-practitioners-controlled-substances- and then transfer the prescription to that pharmacy that some patients may prefer additional carries and covid-19-pandemic.html Per Health Canada, any individual who delivers a (if permitted in the province/territory). fewer observed doses while others may prefer more 2. Frequently asked questions [related to “Subsection 56(1) controlled substance on behalf of a pharmacist must • When planning each day’s medication delivery frequent contact with health care providers. As such, class exemption for patients, practitioners and pharmacists Delivery of Opioid Agonist Treatment during a Pandemic meet the following legislative requirements:1 schedule, give priority to patients receiving OAT to workflow and processes should be continuously prescribing and providing controlled substances in Canada during the coronavirus pandemic]. Ottawa (ON): Health reduce the risk of a missed dose and maintain reviewed to ensure safe, secure, and effective Canada; 2020 Mar 23 [updated 2020 Apr 21; cited 2020 • delivers the controlled substance to the individual consistent delivery times, where possible. delivery of OAT to meet individual patient needs. Apr 24]. Available from: https://www.canada.ca/en/health- The provision of uninterrupted opioid agonist delivery was overlooked one day because of a identified in the prescription (or to a person • Aim to employ a consistent person (or two) for these canada/services/health-concerns/controlled-substances- treatment (OAT) is an important patient care service particularly high volume of deliveries (attributable to responsible for that individual’s care); specialized deliveries, as familiarity with the process ACKNOWLEDGEMENT precursor-chemicals/policy-regulations/policy-documents/ section-56-1-class-exemption-patients-pharmacists- that pharmacies offer to treat opioid use disorder. the pandemic). As a result, the patient missed that • obtains a written note from the pharmacist that and the patient(s) would be helpful in identifying practitioners-controlled-substances-covid-19-pandemic/ OAT, particularly when provided as directly observed day’s dose. identifies the delivery person, states the name and concerns that require pharmacist intervention. ISMP Canada gratefully acknowledges input from the frequently-asked-questions.html therapy, is challenging during the COVID-19 quantity of the controlled substance to be • Reconcile deliveries with prescription hardcopies following individuals (in alphabetical order): 3. COVID-19 and controlled drug substances. Ottawa (ON): pandemic because of the need for physical distancing BACKGROUND delivered, and specifies the place of delivery; and to ensure that all OAT doses have been delivered, Heather Christ RPh BScPharm, Pharmacy Practice Canadian Pharmacists Association. 2020 Jun 9. and because patients may be quarantined or self- • carries the above-described note, as well as a copy and for directly observed OAT, that observation of Advisor, New Brunswick College of Pharmacists; 4. Early guidance for pharmacists in managing opioid agonist treatment during the COVID-19 pandemic. Toronto (ON): isolating. To support continuity of care to patients Medications used for OAT include buprenorphine- of the federal exemption, while effecting the dose ingestion has been documented. Ronda Eros B.Sc.(Pharm.), Practice Consultant, Centre for Addiction and Mental Health; 2020 Mar 27 during this time, Health Canada has issued temporary naloxone, methadone, and extended-release delivery. • Pharmacy decisions and revised procedures for the College of Pharmacists of Manitoba; Mona Kwong [cited 2020 Apr 24]. Available from: https://www.camh.ca/-/ regulatory exemptions for providing OAT to allow morphine, all of which are taken once daily. Directly safe delivery and/or direct observation of OAT RPh, BSc(Pharm), PharmD, MSc, Pharmacy Advisor media/files/camh-covid-19-oat-guidance-for-pharmacists- prescribers to order OAT verbally and pharmacists to observed therapy is typically reserved for patients With Health Canada’s temporary amendments for the during the pandemic should be available to all and Director Addictions Pharmacy Fellowship pdf.pdf?la=en&hash=ECEB406CEB7E973EE4A3B637520A AAA974D642B7 extend, renew, or transfer OAT prescriptions. Regula- who are in the stabilization or early maintenance delivery of controlled substances by a designated pharmacy staff. Program, BC Centre on Substance Use, Vancouver, 5. Exemptions to the opioid agonist therapy “OAT” standards tory exemptions also take into account the need for phases of opioid use disorder treatment and those individual, and considering the frequent deliveries BC; Kim McIntosh B.Sc.(Pharm.), Assistant during the COVID-19 pandemic. Regina (SK): Saskatchewan physical distancing when pharmacists observe and who may benefit from a more structured therapy and need for patient assessment associated with OAT, Ensure Physical Distancing Registrar – Qualifications and Practice College of Pharmacy Professionals; 2020 Mar 25 [cited 2020 document doses ingested by a patient and permit approach. Patients who require daily directly some provincial regulatory bodies have implemented Development, College of Pharmacists of Manitoba; Apr 28]. Available from: https://saskpharm.ca/document/ additional options for delivering medications to the observed therapy usually attend the pharmacy so that additional guidance specific to the safe delivery and • Use virtual communication (if permitted in the Beth Sproule RPh PharmD, Clinician Scientist, 5909/COVID-19_OAT_Comm_20200325.pdf 1,2 6. Novel coronavirus (COVID-19): Medication delivery and patient’s home. Following Health Canada’s their ingestion of the OAT medication dose can be observed dosing of OAT. Practitioners need to ensure province/territory) to connect with the patient, to Centre for Addiction and Mental Health and Leslie pickup. Vancouver (BC): College of Pharmacists of British temporary amendments, some provincial/territorial witnessed and documented by a pharmacist. Patients that their workflow and processes align with enable the pharmacist’s assessment of the patient, Dan Faculty of Pharmacy, University of Toronto, ON. Columbia; 2020 Apr 22 [cited 2020 Apr 28]. Available from: regulatory bodies have implemented additional whose condition has stabilized on a given treatment jurisdictional requirements.4,5,8 and when necessary, allow for direct observation of https://www.bcpharmacists.org/covid19#Delivery_Pickup guidance specific to the safe delivery and observed dose of OAT can then receive take-home doses of dose ingestion. 7. Kalvik A, Isaac P. The importance of missed doses in 3 RECOMMENDATIONS methadone maintenance treatment (MMT). Pharm Connect. dosing of OAT, as needed. This bulletin focuses on medication, also known as “carries”, with • Considerations for maintaining physical distancing 2013 Fall [cited 2020 Apr 28]:22-24. Available from: developing robust OAT-related delivery processes to increasingly fewer directly observed doses. Several include delivering the prescription to the door https://www.ocpinfo.com/library/practice-related/download/ support patients during the pandemic, limiting the provincial pharmacy regulators, as well as the Centre The following recommendations are intended to (with the pick-up within view of the delivery Importance%20of%20Missed%20Doses.pdf exposure of pharmacy staff to COVID-19 by for Addiction and Mental Health, have provided support pharmacy workflow in providing safe person) and having a physical barrier (e.g., glass 8. Professional practice policy-71. Delivery of opioid agonist implementing virtual communication, and managing additional guidance for pharmacists on how to delivery and observed dosing of OAT and should be door) in place during communication. treatment. Vancouver (BC): College of Pharmacists of British Columbia; 2013 Jun 21 [updated 2020 Apr 6; cited 2020 the risks for medication errors. support patients who are receiving OAT for opioid considered together with jurisdictional requirements. Apr 30]. Available from: http://library.bcpharmacists.org/ use disorder during the pandemic.4-6 Share Key Information with Patients 6_Resources/6-2_PPP/5003-PGP-PPP71.pdf INCIDENT EXAMPLE Evaluate the Patient’s Readiness to Receive Carries For any patient receiving OAT, missing a dose could • Review safe storage conditions for OAT carries, A patient who was receiving daily directly observed cause withdrawal symptoms and destabilization, • Work with prescribers to proactively identify including secure storage in a locked cabinet or box therapy with buprenorphine-naloxone had to begin a which must be reported to the prescriber.7 To mitigate patients who could receive carries and confirm the (and in the refrigerator for diluted methadone). period of self-isolation. At the request of the this potential harm, pharmacies providing home optimal frequency of deliveries and observed doses. • Inform patients of the need to contact the prescriber, the pharmacy scheduled daily deliveries of delivery of OAT medications should build additional This requires assessing the risk of harm both to the pharmacist immediately if a delivery is missed or if the OAT medication to the patient’s home. The quality checks into their delivery processes. patient and to others residing at the same location.5 they receive the wrong medication or dose.
ISMP Canada Safety Bulletin – www.ismp-canada.org/ISMPCSafetyBulletins.htm 1 of 4 TEMPORARY REGULATORY EXEMPTIONS Assess Pharmacy Infrastructure and Processes for CONCLUSION REFERENCES DURING THE PANDEMIC Providing Delivery Services Temporary legislative exemptions have been enacted 1. Subsection 56(1) class exemption for patients, practitioners Health Canada’s temporary exemptions to the • Review existing delivery services to ensure during the pandemic to ensure that patients receive an and pharmacists prescribing and providing controlled substances in Canada during the coronavirus pandemic. Controlled Drugs and Substances Act allow pharma- compliance with provincial/territorial uninterrupted supply of controlled substances, Ottawa (ON): Health Canada; 2020 Mar 19 [updated 2020 cists to authorize an individual (e.g., pharmacy requirements. If your own pharmacy is unable to including OAT, with maintenance of physical Apr 21; cited 2020 Apr 24]. Available from: employee) to deliver prescriptions containing deliver OAT as often as the patient requires, work distancing. There are several ongoing research https://www.canada.ca/en/health-canada/services/health- controlled drugs, such as OAT, to patients’ homes or with the patient to identify a pharmacy that can initiatives studying the impact of the pandemic on concerns/controlled-substances-precursor-chemicals/policy- 1 regulations/policy-documents/section-56-1-class-exemption- to other locations where patients are self-isolating. reliably provide safe delivery of the medication, care of patients with opioid use disorder, recognizing patients-pharmacists-practitioners-controlled-substances- and then transfer the prescription to that pharmacy that some patients may prefer additional carries and covid-19-pandemic.html Per Health Canada, any individual who delivers a (if permitted in the province/territory). fewer observed doses while others may prefer more 2. Frequently asked questions [related to “Subsection 56(1) controlled substance on behalf of a pharmacist must • When planning each day’s medication delivery frequent contact with health care providers. As such, class exemption for patients, practitioners and pharmacists meet the following legislative requirements:1 schedule, give priority to patients receiving OAT to workflow and processes should be continuously prescribing and providing controlled substances in Canada during the coronavirus pandemic]. Ottawa (ON): Health reduce the risk of a missed dose and maintain reviewed to ensure safe, secure, and effective Canada; 2020 Mar 23 [updated 2020 Apr 21; cited 2020 • delivers the controlled substance to the individual consistent delivery times, where possible. delivery of OAT to meet individual patient needs. Apr 24]. Available from: https://www.canada.ca/en/health- The provision of uninterrupted opioid agonist delivery was overlooked one day because of a identified in the prescription (or to a person • Aim to employ a consistent person (or two) for these canada/services/health-concerns/controlled-substances- treatment (OAT) is an important patient care service particularly high volume of deliveries (attributable to responsible for that individual’s care); specialized deliveries, as familiarity with the process ACKNOWLEDGEMENT precursor-chemicals/policy-regulations/policy-documents/ section-56-1-class-exemption-patients-pharmacists- that pharmacies offer to treat opioid use disorder. the pandemic). As a result, the patient missed that • obtains a written note from the pharmacist that and the patient(s) would be helpful in identifying practitioners-controlled-substances-covid-19-pandemic/ OAT, particularly when provided as directly observed day’s dose. identifies the delivery person, states the name and concerns that require pharmacist intervention. ISMP Canada gratefully acknowledges input from the frequently-asked-questions.html therapy, is challenging during the COVID-19 quantity of the controlled substance to be • Reconcile deliveries with prescription hardcopies following individuals (in alphabetical order): 3. COVID-19 and controlled drug substances. Ottawa (ON): pandemic because of the need for physical distancing BACKGROUND delivered, and specifies the place of delivery; and to ensure that all OAT doses have been delivered, Heather Christ RPh BScPharm, Pharmacy Practice Canadian Pharmacists Association. 2020 Jun 9. and because patients may be quarantined or self- • carries the above-described note, as well as a copy and for directly observed OAT, that observation of Advisor, New Brunswick College of Pharmacists; 4. Early guidance for pharmacists in managing opioid agonist treatment during the COVID-19 pandemic. Toronto (ON): isolating. To support continuity of care to patients Medications used for OAT include buprenorphine- of the federal exemption, while effecting the dose ingestion has been documented. Ronda Eros B.Sc.(Pharm.), Practice Consultant, Centre for Addiction and Mental Health; 2020 Mar 27 during this time, Health Canada has issued temporary naloxone, methadone, and extended-release delivery. • Pharmacy decisions and revised procedures for the College of Pharmacists of Manitoba; Mona Kwong [cited 2020 Apr 24]. Available from: https://www.camh.ca/-/ regulatory exemptions for providing OAT to allow morphine, all of which are taken once daily. Directly safe delivery and/or direct observation of OAT RPh, BSc(Pharm), PharmD, MSc, Pharmacy Advisor media/files/camh-covid-19-oat-guidance-for-pharmacists- prescribers to order OAT verbally and pharmacists to observed therapy is typically reserved for patients With Health Canada’s temporary amendments for the during the pandemic should be available to all and Director Addictions Pharmacy Fellowship pdf.pdf?la=en&hash=ECEB406CEB7E973EE4A3B637520A AAA974D642B7 extend, renew, or transfer OAT prescriptions. Regula- who are in the stabilization or early maintenance delivery of controlled substances by a designated pharmacy staff. Program, BC Centre on Substance Use, Vancouver, 5. Exemptions to the opioid agonist therapy “OAT” standards tory exemptions also take into account the need for phases of opioid use disorder treatment and those individual, and considering the frequent deliveries BC; Kim McIntosh B.Sc.(Pharm.), Assistant during the COVID-19 pandemic. Regina (SK): Saskatchewan physical distancing when pharmacists observe and who may benefit from a more structured therapy and need for patient assessment associated with OAT, Ensure Physical Distancing Registrar – Qualifications and Practice College of Pharmacy Professionals; 2020 Mar 25 [cited 2020 document doses ingested by a patient and permit approach. Patients who require daily directly some provincial regulatory bodies have implemented Development, College of Pharmacists of Manitoba; Apr 28]. Available from: https://saskpharm.ca/document/ additional options for delivering medications to the observed therapy usually attend the pharmacy so that additional guidance specific to the safe delivery and • Use virtual communication (if permitted in the Beth Sproule RPh PharmD, Clinician Scientist, 5909/COVID-19_OAT_Comm_20200325.pdf 1,2 6. Novel coronavirus (COVID-19): Medication delivery and patient’s home. Following Health Canada’s their ingestion of the OAT medication dose can be observed dosing of OAT. Practitioners need to ensure province/territory) to connect with the patient, to Centre for Addiction and Mental Health and Leslie pickup. Vancouver (BC): College of Pharmacists of British temporary amendments, some provincial/territorial witnessed and documented by a pharmacist. Patients that their workflow and processes align with enable the pharmacist’s assessment of the patient, Dan Faculty of Pharmacy, University of Toronto, ON. Columbia; 2020 Apr 22 [cited 2020 Apr 28]. Available from: regulatory bodies have implemented additional whose condition has stabilized on a given treatment jurisdictional requirements.4,5,8 and when necessary, allow for direct observation of https://www.bcpharmacists.org/covid19#Delivery_Pickup guidance specific to the safe delivery and observed dose of OAT can then receive take-home doses of dose ingestion. 7. Kalvik A, Isaac P. The importance of missed doses in 3 RECOMMENDATIONS methadone maintenance treatment (MMT). Pharm Connect. dosing of OAT, as needed. This bulletin focuses on medication, also known as “carries”, with • Considerations for maintaining physical distancing 2013 Fall [cited 2020 Apr 28]:22-24. Available from: developing robust OAT-related delivery processes to increasingly fewer directly observed doses. Several include delivering the prescription to the door https://www.ocpinfo.com/library/practice-related/download/ support patients during the pandemic, limiting the provincial pharmacy regulators, as well as the Centre The following recommendations are intended to (with the pick-up within view of the delivery Importance%20of%20Missed%20Doses.pdf exposure of pharmacy staff to COVID-19 by for Addiction and Mental Health, have provided support pharmacy workflow in providing safe person) and having a physical barrier (e.g., glass 8. Professional practice policy-71. Delivery of opioid agonist implementing virtual communication, and managing additional guidance for pharmacists on how to delivery and observed dosing of OAT and should be door) in place during communication. treatment. Vancouver (BC): College of Pharmacists of British Columbia; 2013 Jun 21 [updated 2020 Apr 6; cited 2020 the risks for medication errors. support patients who are receiving OAT for opioid considered together with jurisdictional requirements. Apr 30]. Available from: http://library.bcpharmacists.org/ use disorder during the pandemic.4-6 Share Key Information with Patients 6_Resources/6-2_PPP/5003-PGP-PPP71.pdf INCIDENT EXAMPLE Evaluate the Patient’s Readiness to Receive Carries For any patient receiving OAT, missing a dose could • Review safe storage conditions for OAT carries, A patient who was receiving daily directly observed cause withdrawal symptoms and destabilization, • Work with prescribers to proactively identify including secure storage in a locked cabinet or box therapy with buprenorphine-naloxone had to begin a which must be reported to the prescriber.7 To mitigate patients who could receive carries and confirm the (and in the refrigerator for diluted methadone). period of self-isolation. At the request of the this potential harm, pharmacies providing home optimal frequency of deliveries and observed doses. • Inform patients of the need to contact the prescriber, the pharmacy scheduled daily deliveries of delivery of OAT medications should build additional This requires assessing the risk of harm both to the pharmacist immediately if a delivery is missed or if the OAT medication to the patient’s home. The quality checks into their delivery processes. patient and to others residing at the same location.5 they receive the wrong medication or dose.
ISMP Canada Safety Bulletin – Volume 20 • Issue 6 • June 9, 2020 2 of 4 TEMPORARY REGULATORY EXEMPTIONS Assess Pharmacy Infrastructure and Processes for CONCLUSION REFERENCES DURING THE PANDEMIC Providing Delivery Services Temporary legislative exemptions have been enacted 1. Subsection 56(1) class exemption for patients, practitioners Health Canada’s temporary exemptions to the • Review existing delivery services to ensure during the pandemic to ensure that patients receive an and pharmacists prescribing and providing controlled substances in Canada during the coronavirus pandemic. Controlled Drugs and Substances Act allow pharma- compliance with provincial/territorial uninterrupted supply of controlled substances, Ottawa (ON): Health Canada; 2020 Mar 19 [updated 2020 cists to authorize an individual (e.g., pharmacy requirements. If your own pharmacy is unable to including OAT, with maintenance of physical Apr 21; cited 2020 Apr 24]. Available from: employee) to deliver prescriptions containing deliver OAT as often as the patient requires, work distancing. There are several ongoing research https://www.canada.ca/en/health-canada/services/health- controlled drugs, such as OAT, to patients’ homes or with the patient to identify a pharmacy that can initiatives studying the impact of the pandemic on concerns/controlled-substances-precursor-chemicals/policy- 1 regulations/policy-documents/section-56-1-class-exemption- to other locations where patients are self-isolating. reliably provide safe delivery of the medication, care of patients with opioid use disorder, recognizing patients-pharmacists-practitioners-controlled-substances- and then transfer the prescription to that pharmacy that some patients may prefer additional carries and covid-19-pandemic.html Per Health Canada, any individual who delivers a (if permitted in the province/territory). fewer observed doses while others may prefer more 2. Frequently asked questions [related to “Subsection 56(1) controlled substance on behalf of a pharmacist must • When planning each day’s medication delivery frequent contact with health care providers. As such, class exemption for patients, practitioners and pharmacists meet the following legislative requirements:1 schedule, give priority to patients receiving OAT to workflow and processes should be continuously prescribing and providing controlled substances in Canada during the coronavirus pandemic]. Ottawa (ON): Health reduce the risk of a missed dose and maintain reviewed to ensure safe, secure, and effective Canada; 2020 Mar 23 [updated 2020 Apr 21; cited 2020 • delivers the controlled substance to the individual consistent delivery times, where possible. delivery of OAT to meet individual patient needs. Apr 24]. Available from: https://www.canada.ca/en/health- The provision of uninterrupted opioid agonist delivery was overlooked one day because of a identified in the prescription (or to a person • Aim to employ a consistent person (or two) for these canada/services/health-concerns/controlled-substances- treatment (OAT) is an important patient care service particularly high volume of deliveries (attributable to responsible for that individual’s care); specialized deliveries, as familiarity with the process ACKNOWLEDGEMENT precursor-chemicals/policy-regulations/policy-documents/ section-56-1-class-exemption-patients-pharmacists- that pharmacies offer to treat opioid use disorder. the pandemic). As a result, the patient missed that • obtains a written note from the pharmacist that and the patient(s) would be helpful in identifying practitioners-controlled-substances-covid-19-pandemic/ OAT, particularly when provided as directly observed day’s dose. identifies the delivery person, states the name and concerns that require pharmacist intervention. ISMP Canada gratefully acknowledges input from the frequently-asked-questions.html therapy, is challenging during the COVID-19 quantity of the controlled substance to be • Reconcile deliveries with prescription hardcopies following individuals (in alphabetical order): 3. COVID-19 and controlled drug substances. Ottawa (ON): pandemic because of the need for physical distancing BACKGROUND delivered, and specifies the place of delivery; and to ensure that all OAT doses have been delivered, Heather Christ RPh BScPharm, Pharmacy Practice Canadian Pharmacists Association. 2020 Jun 9. and because patients may be quarantined or self- • carries the above-described note, as well as a copy and for directly observed OAT, that observation of Advisor, New Brunswick College of Pharmacists; 4. Early guidance for pharmacists in managing opioid agonist treatment during the COVID-19 pandemic. Toronto (ON): isolating. To support continuity of care to patients Medications used for OAT include buprenorphine- of the federal exemption, while effecting the dose ingestion has been documented. Ronda Eros B.Sc.(Pharm.), Practice Consultant, Centre for Addiction and Mental Health; 2020 Mar 27 during this time, Health Canada has issued temporary naloxone, methadone, and extended-release delivery. • Pharmacy decisions and revised procedures for the College of Pharmacists of Manitoba; Mona Kwong [cited 2020 Apr 24]. Available from: https://www.camh.ca/-/ regulatory exemptions for providing OAT to allow morphine, all of which are taken once daily. Directly safe delivery and/or direct observation of OAT RPh, BSc(Pharm), PharmD, MSc, Pharmacy Advisor media/files/camh-covid-19-oat-guidance-for-pharmacists- prescribers to order OAT verbally and pharmacists to observed therapy is typically reserved for patients With Health Canada’s temporary amendments for the during the pandemic should be available to all and Director Addictions Pharmacy Fellowship pdf.pdf?la=en&hash=ECEB406CEB7E973EE4A3B637520A AAA974D642B7 extend, renew, or transfer OAT prescriptions. Regula- who are in the stabilization or early maintenance delivery of controlled substances by a designated pharmacy staff. Program, BC Centre on Substance Use, Vancouver, 5. Exemptions to the opioid agonist therapy “OAT” standards tory exemptions also take into account the need for phases of opioid use disorder treatment and those individual, and considering the frequent deliveries BC; Kim McIntosh B.Sc.(Pharm.), Assistant during the COVID-19 pandemic. Regina (SK): Saskatchewan physical distancing when pharmacists observe and who may benefit from a more structured therapy and need for patient assessment associated with OAT, Ensure Physical Distancing Registrar – Qualifications and Practice College of Pharmacy Professionals; 2020 Mar 25 [cited 2020 document doses ingested by a patient and permit approach. Patients who require daily directly some provincial regulatory bodies have implemented Development, College of Pharmacists of Manitoba; Apr 28]. Available from: https://saskpharm.ca/document/ additional options for delivering medications to the observed therapy usually attend the pharmacy so that additional guidance specific to the safe delivery and • Use virtual communication (if permitted in the Beth Sproule RPh PharmD, Clinician Scientist, 5909/COVID-19_OAT_Comm_20200325.pdf 1,2 6. Novel coronavirus (COVID-19): Medication delivery and patient’s home. Following Health Canada’s their ingestion of the OAT medication dose can be observed dosing of OAT. Practitioners need to ensure province/territory) to connect with the patient, to Centre for Addiction and Mental Health and Leslie pickup. Vancouver (BC): College of Pharmacists of British temporary amendments, some provincial/territorial witnessed and documented by a pharmacist. Patients that their workflow and processes align with enable the pharmacist’s assessment of the patient, Dan Faculty of Pharmacy, University of Toronto, ON. Columbia; 2020 Apr 22 [cited 2020 Apr 28]. Available from: regulatory bodies have implemented additional whose condition has stabilized on a given treatment jurisdictional requirements.4,5,8 and when necessary, allow for direct observation of https://www.bcpharmacists.org/covid19#Delivery_Pickup guidance specific to the safe delivery and observed dose of OAT can then receive take-home doses of dose ingestion. 7. Kalvik A, Isaac P. The importance of missed doses in 3 RECOMMENDATIONS methadone maintenance treatment (MMT). Pharm Connect. dosing of OAT, as needed. This bulletin focuses on medication, also known as “carries”, with • Considerations for maintaining physical distancing 2013 Fall [cited 2020 Apr 28]:22-24. Available from: developing robust OAT-related delivery processes to increasingly fewer directly observed doses. Several include delivering the prescription to the door https://www.ocpinfo.com/library/practice-related/download/ support patients during the pandemic, limiting the provincial pharmacy regulators, as well as the Centre The following recommendations are intended to (with the pick-up within view of the delivery Importance%20of%20Missed%20Doses.pdf exposure of pharmacy staff to COVID-19 by for Addiction and Mental Health, have provided support pharmacy workflow in providing safe person) and having a physical barrier (e.g., glass 8. Professional practice policy-71. Delivery of opioid agonist implementing virtual communication, and managing additional guidance for pharmacists on how to delivery and observed dosing of OAT and should be door) in place during communication. treatment. Vancouver (BC): College of Pharmacists of British Columbia; 2013 Jun 21 [updated 2020 Apr 6; cited 2020 the risks for medication errors. support patients who are receiving OAT for opioid considered together with jurisdictional requirements. Apr 30]. Available from: http://library.bcpharmacists.org/ use disorder during the pandemic.4-6 Share Key Information with Patients 6_Resources/6-2_PPP/5003-PGP-PPP71.pdf INCIDENT EXAMPLE Evaluate the Patient’s Readiness to Receive Carries For any patient receiving OAT, missing a dose could • Review safe storage conditions for OAT carries, A patient who was receiving daily directly observed cause withdrawal symptoms and destabilization, • Work with prescribers to proactively identify including secure storage in a locked cabinet or box therapy with buprenorphine-naloxone had to begin a which must be reported to the prescriber.7 To mitigate patients who could receive carries and confirm the (and in the refrigerator for diluted methadone). period of self-isolation. At the request of the this potential harm, pharmacies providing home optimal frequency of deliveries and observed doses. • Inform patients of the need to contact the prescriber, the pharmacy scheduled daily deliveries of delivery of OAT medications should build additional This requires assessing the risk of harm both to the pharmacist immediately if a delivery is missed or if the OAT medication to the patient’s home. The quality checks into their delivery processes. patient and to others residing at the same location.5 they receive the wrong medication or dose.
ISMP Canada Safety Bulletin – Volume 20 • Issue 6 • June 9, 2020 3 of 4 NEW! Buprenor phine/Naloxone and Methadone Handouts METHADONE
Seeking help for your opioid dependence is a wise and important step in your road to recovery. There are people who can help you to develop goals and who can support you along the way. Talk to your healthcare provider about your support options. Methadone is an opioid used to treat opioid use disorder. Unlike most opioids, methadone lasts a long time in your body to help prevent cravings and feelings of withdrawal. Once you’ve taken this medication for a while, you should feel for Patients: Your Questions Answered more energetic and clear-headed. This will let you focus on things like work, school, and family. 1. Changes? You’ve been prescribed methadone for opioid use disorder (opioid dependence). You’ll take the rst dose of methadone in the presence of a health care provider. The rst dose will be small to see how you tolerate it. The dose can be increased based on how you feel. It may take weeks to get to the dose that is right for you. 2. Continue? You and your health care provider will decide how long you’ll take methadone. Usually, long-term treatment is most e ective (e.g., months to years). You may decide to try stopping this medication at some point. It’s important to do this together with your health care provider so the dose can be lowered very slowly. 3. Proper Use? Methadone is a liquid medication. It’s mixed with juice by a pharmacist and given to you to drink at the pharmacy. When starting methadone, you will have to go to the pharmacy every day to take your dose. Over time many people can take doses at home – these are called “carries”. Talk with your healthcare provider about how to manage missed doses, as changes to your medication may be Key stakeholders in Saskatchewan identi ed an information need among patients who needed. Overdose can happen with methadone when it’s not taken properly. Do not take other opioids, alcohol, or sleeping pills (e.g., benzodiazepines like lorazepam [Ativan]) while on this medication, as they increase the risk of an overdose. It may not be safe to drive a car or operate machinery when you rst start taking this medication. 4. Monitor? You may experience side e ects, especially when you start methadone or increase the dose. You may feel light-headed, dizzy, drowsy, and sweaty. You may be constipated. You might also feel sick to your stomach and vomit. These side e ects may go away as your body gets used to the SUBOXONE are initiating opioid agonist therapy for treatment of opioid use disorder. In response, medication but if they do not, talk with your health care provider. Contact a health care provider right away if you have a hard time breathing or staying awake, are experiencing severe dizziness or chest pain, or if you feel a rapid or irregular heartbeat.
5. Follow-up?Seeking help for your opioid dependence is a wise and important step in your road to recovery. There are people who can help you to develop goals and who can support you along the way. Talk to your healthcare When you start methadone, you’ll have extra visits with your health care provider. Your health provider about your support options. care provider will want to see how you’re feeling and may change your dose if needed. You’ll also need to provide urine samplesBuprenorphine/naloxone when asked by your (brand health name care provider.Suboxone) contains an opioid used to treat opioid use disorder. Unlike most opioids, buprenorphine/naloxone lasts a long time in your body to help prevent cravings and feelings of withdrawal. Once you’ve several provincial and national organizations collaborated to develop handouts for taken this medication for a while, you should feel more energetic and clear-headed. This will let you focus on things like work, school, and family. 1. Changes? You’ve been prescribed buprenorphine/naloxone (brand name Suboxone) for opioid use disorder (opioid dependence). You’ll likely take your rst dose of buprenorphine/naloxone in the presence of a health care provider when you feel symptoms of withdrawal. 12-36 hours before your rst dose, you’ll need to stop taking other opioids. Your withdrawal symptoms should get better when you start this medication. They should go away once you get on the dose that is right for you, but it may take a few days patients for whom buprenorphine/naloxone or methadone has been prescribed. These to get to the right dose. 2. Continue? You and your health care provider will decide how long you’ll take buprenorphine/naloxone. Usually, long-term treatment is most e ective (e.g., months to years). You may decide to try stopping this medication at some point. It’s important to do this with your health care provider so the dose can be lowered very slowly. handouts share advice about the risks, bene ts, and adverse e ects of buprenorphine/ 3. Proper Use? Buprenorphine/naloxone is a pill that is placed under your tongue and dissolves. This can take up to 10 minutes. Do not swallow, eat, drink, or smoke while the pill dissolves. You may have to go to the pharmacy as often as daily to take your dose. Over time, many people can take doses at home – these are called “carries”. Talk with your healthcare provider about how to manage missed doses, as changes to your medication may be needed. The risk of overdose is lower with buprenorphine/naloxone compared to methadone. However, do not take other opioids, alcohol, or sleeping pills (e.g., benzodiazepines like lorazepam [Ativan]) while on buprenorphine/naloxone, as they can increase the risk of an overdose. It may not be safe to drive a car or operate machinery when you rst start taking this medication. naloxone and methadone, as well as tips on proper storage and disposal of these drugs. 4. Monitor? You may experience side e ects, especially when you start buprenorphine/naloxone or increase the dose. You may feel anxious, drowsy, dizzy, or depressed. You may have trouble sleeping and may be constipated. You might have a headache, and you may feel symptoms of withdrawal such as sweating, diarrhea, or feeling sick to your stomach. These side e ects may go away once your body gets used to the medication but if they do not, talk with your health care provider. Contact a health care provider right away if you have a hard time breathing, staying awake, or are experiencing severe dizziness. 5. Follow-up? When you start buprenorphine/naloxone, you’ll have extra visits with your health care provider. Your health care provider will want to see how you are feeling and may change your dose if needed. You’ll Click here to learn more: also need to provide urine samples when asked by your health care provider. • Buprenorphine/Naloxone (Suboxone) for Opioid Use Disorder: Your Questions Answered • Methadone for Opioid Use Disorder: Your Questions Answered For information about customization opportunities to add your logo, please email [email protected]
Report Medication Incidents (Including near misses) The Canadian Medication Incident Reporting and Prevention Online: www.ismp-canada.org/err_index.htm System (CMIRPS) is a collaborative pan-Canadian program of Phone: 1-866-544-7672 Health Canada, the Canadian Institute for Health Information (CIHI), the Institute for Safe Medication Practices Canada ISMP Canada strives to ensure confidentiality and security of information received, and respects the wishes (ISMP Canada) and the Canadian Patient Safety Institute of the reporter as to the level of detail to be included in (CPSI). The goal of CMIRPS is to reduce and prevent harmful publications. Medication Safety bulletins contribute to medication incidents in Canada. Global Patient Safety Alerts. Stay Informed To receive ISMP Canada Safety Bulletins and Newsletters visit: The Healthcare Insurance Reciprocal of Canada (HIROC) www.ismp-canada.org/stayinformed/ provides support for the bulletin and is a member owned expert provider of professional and general liability coverage This bulletin shares information about safe medication and risk management support. practices, is noncommercial, and is therefore exempt from Canadian anti-spam legislation.
Contact Us Email: [email protected] The Institute for Safe Medication Practices Canada (ISMP Phone: 1-866-544-7672 Canada) is an independent national not-for-profit ©2020 Institute for Safe Medication Practices Canada. organization committed to the advancement of medication safety in all healthcare settings. ISMP Canada's mandate includes analyzing medication incidents, making recommendations for the prevention of harmful medication incidents, and facilitating quality improvement initiatives.
ISMP Canada Safety Bulletin – Volume 20 • Issue 6 • June 9, 2020 4 of 4