Delivery of Opioid Agonist Treatment during a Pandemic

INCIDENT EXAMPLE

A patient who was receiving daily directly observed therapy with buprenorphine-naloxone had to begin a period of self-isolation. At the request of the prescriber, the pharmacy scheduled daily deliveries of the OAT medication to the patient’s home. The delivery was overlooked one day because of a particularly high volume of deliveries (attributable to the pandemic). As a result, the patient missed that day’s dose.

BACKGROUND

Medications used for OAT include buprenorphine-naloxone, methadone, and extended-release morphine, all of which are taken once daily. Directly observed therapy is typically reserved for patients who are in the stabilization or early maintenance phases of opioid use disorder treatment and those who may benefit from a more structured therapy approach. Patients who require daily directly observed therapy usually attend the pharmacy so that their ingestion of the OAT medication dose can be witnessed and documented by a pharmacist. Patients whose condition has stabilized on a given treatment dose of OAT can then receive take-home doses of medication, also known as “carries”, with increasingly fewer directly observed doses. Several provincial pharmacy regulators, as well as the Centre for Addiction and Mental Health, have provided additional guidance for pharmacists on how to support patients who are receiving OAT for opioid use disorder during the pandemic.^4-6

For any patient receiving OAT, missing a dose could cause withdrawal symptoms and destabilization, which must be reported to the prescriber.⁷ To mitigate this potential harm, pharmacies providing home delivery of OAT medications should build additional quality checks into their delivery processes.

TEMPORARY REGULATORY EXEMPTIONS DURING THE PANDEMIC

Health Canada’s temporary exemptions to the Controlled Drugs and Substances Act allow pharmacists to authorize an individual (e.g., pharmacy employee) to deliver prescriptions containing controlled drugs, such as OAT, to patients’ homes or to other locations where patients are self-isolating.¹

Per Health Canada, any individual who delivers a controlled substance on behalf of a pharmacist must meet the following legislative requirements:¹

• delivers the controlled substance to the individual identified in the prescription (or to a person responsible for that individual’s care);
• obtains a written note from the pharmacist that identifies the delivery person, states the name and quantity of the controlled substance to be delivered, and specifies the place of delivery; and
• carries the above-described note, as well as a copy of the federal exemption, while effecting the delivery.

With Health Canada’s temporary amendments for the delivery of controlled substances by a designated individual, and considering the frequent deliveries and need for patient assessment associated with OAT, some provincial regulatory bodies have implemented additional guidance specific to the safe delivery and observed dosing of OAT. Practitioners need to ensure that their workflow and processes align with jurisdictional requirements.^4,5,8

RECOMMENDATIONS

The following recommendations are intended to support pharmacy workflow in providing safe delivery and observed dosing of OAT and should be considered together with jurisdictional requirements.

Evaluate the Patient’s Readiness to Receive Carries

• Work with prescribers to proactively identify patients who could receive carries and confirm the optimal frequency of deliveries and observed doses. This requires assessing the risk of harm both to the patient and to others residing at the same location.⁵

Assess Pharmacy Infrastructure and Processes for Providing Delivery Services

• Review existing delivery services to ensure compliance with provincial/territorial requirements. If your own pharmacy is unable to deliver OAT as often as the patient requires, work with the patient to identify a pharmacy that can reliably provide safe delivery of the medication, and then transfer the prescription to that pharmacy (if permitted in the province/territory).
• When planning each day’s medication delivery schedule, give priority to patients receiving OAT to reduce the risk of a missed dose and maintain consistent delivery times, where possible.
• Aim to employ a consistent person (or two) for these specialized deliveries, as familiarity with the process and the patient(s) would be helpful in identifying concerns that require pharmacist intervention.
• Reconcile deliveries with prescription hardcopies to ensure that all OAT doses have been delivered, and for directly observed OAT, that observation of dose ingestion has been documented.
• Pharmacy decisions and revised procedures for the safe delivery and/or direct observation of OAT during the pandemic should be available to all pharmacy staff.

Ensure Physical Distancing

• Use virtual communication (if permitted in the province/territory) to connect with the patient, to enable the pharmacist’s assessment of the patient, and when necessary, allow for direct observation of dose ingestion.
• Considerations for maintaining physical distancing include delivering the prescription to the door (with the pick-up within view of the delivery person) and having a physical barrier (e.g., glass door) in place during communication.

Share Key Information with Patients

• Review safe storage conditions for OAT carries, including secure storage in a locked cabinet or box (and in the refrigerator for diluted methadone).
• Inform patients of the need to contact the pharmacist immediately if a delivery is missed or if they receive the wrong medication or dose.

CONCLUSION

Temporary legislative exemptions have been enacted during the pandemic to ensure that patients receive an uninterrupted supply of controlled substances, including OAT, with maintenance of physical distancing. There are several ongoing research initiatives studying the impact of the pandemic on care of patients with opioid use disorder, recognizing that some patients may prefer additional carries and fewer observed doses while others may prefer more frequent contact with health care providers. As such, workflow and processes should be continuously reviewed to ensure safe, secure, and effective delivery of OAT to meet individual patient needs.