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COVID-19 Guidance - Delivery of drugs to assisted living facilities

This guidance must be followed in context with the Standard of Practice for Pharmacists and Pharmacy Technicians and the applicable provincial and federal legislated requirements, including, but not limited to those stated below.


Page last updated on March 27, 2020, at 11:30 a.m. MT.

Background

Regulated members have ethical responsibilities to both their patients and society. Regulated members must hold the well-being of each patient to be their primary consideration and serve as an essential health resource, especially during times of public emergencies such as the COVID-19 pandemic.

As part of fulfilling these requirements during the pandemic, regulated members may face challenges with delivering prescription drugs into assisted living facilities (ALFs) that have reduced public access or are under quarantine, and ensuring ALF patients are able to receive the drugs they require.

This document is intended to provide regulated members guidance in situations where they may not be able to deliver drugs directly to patients residing in ALFs, or to patients’ agents, as a result of the COVID-19 pandemic.

In these circumstances, regulated members must ensure the integrity of the drug is maintained and their patients’ health information is kept confidential during delivery.

Regulated members must take reasonable steps to maintain a secure drug supply, including minimizing the risk of the unintended harm of others who might come in contact with drugs during transport.

Definitions

Assisted Living Facility (ALF) are those facilities that provide health care and other care services to its residents and are not otherwise included in the facilities defined as a “health care facility” under section 1(f) of the Standards for Practice for Pharmacists and Pharmacy Technicians or which have a pharmacy service relationship with an “institutional pharmacy” defined in section 1(1)(j) of the Pharmacy and Drug Act. ALF’s include long term care facilities and supportive living facilities that are not otherwise defined as a health care facility or have a pharmacy within the facility.

Patient means any person to whom a regulated member provides a service that is within the scope of the practice of pharmacists or the practice of pharmacy technicians (SPPPT Definition 1(h));

Patient’s agent means a family member, caregiver or another individual who has a close personal relationship with the patient (SPPPT Definition 1(i));

Responsible receiver means an employee of an ALF that has been authorized to receive prescribed drugs and other medical supplies from a pharmacy on behalf of the residents of the ALF.

Potential COVID-19 Obstacles and Hazards with Providing Drugs into an ALF 

Individuals who reside in an ALF may be self-isolating or the ALF may be quarantined to outside personnel, including pharmacy staff.

Regulated members must take steps to ensure that when providing drugs to their patients living in an ALF, that pharmacy personnel or the drugs and supplies delivered by the pharmacy do not inadvertently act as a vector for the virus.

Guidance

  • Drugs are to be delivered into the custody of a responsible receiver of the ALF. Whenever possible the responsible receiver should be a regulated health care professional, such as an RN or LPN. At a minimum the responsible receiver must be an employee of the ALF authorized by the ALF manager to receive drugs from the pharmacy on behalf of the ALF’s residents.
  • Prior to delivering drugs to an ALF, the pharmacy must obtain written documentation from the ALF manager establishing who is authorized to be a responsible receiver, and this documentation must be retained at the pharmacy. Further, a copy of this guidance document must be provided to the ALF manager and the responsible receiver, so that they understand their responsibilities once drugs are delivered.
  • Prior to delivering drugs to an ALF’s responsible receiver, a regulated member from the shipping pharmacy should have discussions with the ALF manager to ensure drugs delivered into the custody of a responsible receiver will be securely stored and promptly delivered to each patient’s residence.
  • The pharmacy’s delivery agent must visually confirm and then record the identity of the ALF’s responsible receiver and confirm that the pharmacy has previously been made aware that the responsible receiver is authorized to accept delivery of the drugs.
  • Drugs must NOT be left unattended or unsecured at an ALF or left in a manner that anyone other than the intended patient or responsible receiver has access to the drugs or accompanying health information.
  • Drugs must be delivered in such a manner as to ensure all patient health information is kept confidential.
  • Drugs must be delivered in tamper-resistant packaging.
  • The pharmacy must take reasonable measures to ensure that all drugs are transported in a manner that will not adversely affect the drugs’ integrity.
  • Pharmacies must not store Schedule 1 and 2 drugs outside of a licensed dispensary. The storage  of all Scheduled drugs, that have not been dispensed to specific residents pursuant to a prescription, is not authorized.
  • In accordance with section 6.1(c) of the Pharmacy and Drug Regulation, pharmacies delivering drugs to patients of an ALF that has restricted access due to the COVID-19 pandemic are temporarily exempted from obtaining a pharmacy mail order licence in accordance with section 5(1)(c)  of the Pharmacy and Drug Act. However, if licensees, pharmacists and pharmacy technicians are providing mail order pharmacy service (PDA Definition 1(1)(n.2)) for ALF residents they must still meet all applicable standards and requirements applicable to these services.

Relevant standards and legislation

Pharmacy and Drug Act

Definition        

1(1) (j) “institution pharmacy” means a pharmacy that is operated by

  1. an approved hospital as defined in the Hospitals Act,
  2. a nursing home as defined in the Nursing Homes Act,
  3. a correctional institution as defined in the Corrections Act,
  4. a facility as defined in the Mental Health Act,
  5. a diagnostic or treatment centre made available under section 49(b) of the Mental Health Act,
  6. a facility as defined in section 1(1)(f.1)(ii) and (iii) of the Protection for Persons in Care Act,
  7. a regional health authority or a provincial health board under the Regional Health Authorities Act, or
  8. a hospital, a penitentiary, a correctional institution, a health or social care institution or facility or a residential facility for persons who are aged or infirm or require special care, that is operated in Alberta by the Crown in right of Canada;

31(2) Schedule 1 drugs may

  1. in a licensed pharmacy, be stored only in the dispensary or other secure site authorized by the standards for the operation of licensed pharmacies adopted under section 29.1.

32(2) Schedule 2 drugs may

  1. in a licensed pharmacy, be stored only in the dispensary or other secure site authorized by the standards for the operation of licensed pharmacies adopted under section 29.1.

Pharmacy and Drug Regulation

12.1 The following types of records constitute records for the purposes of section 1(1)(z.1) of the Act:

  1. records of all Schedule 1 and Schedule 2 drugs dispensed from or through the pharmacy, which must include
    1. where the drug was not picked up at the pharmacy by the patient or the patient’s agent, the method of delivery of the drug to the patient and the method of dealing with environmental concerns where appropriate;
  2. in respect of a mail order pharmacy, the following additional records:
    1. policies and procedures regarding how information is collected in order to assess individual patients and to obtain all the information necessary to allow the pharmacist to ensure the appropriateness of drug therapy for the patient, and
    2. records that identify any arrangement or agreement under which patients are referred to the mail order pharmacy in order for the pharmacy to provide mail order pharmacy services to or for the patient;

Standards of Practice for Pharmacists and Pharmacy Technicians

Definition

1(f) health care facility means:

  1. a hospital as defined in the Hospitals Act,
  2. a nursing home as defined in the Nursing Homes Act,
  3. a correctional institution as defined in the Corrections Act, or
  4. a facility as defined in the Mental Health Act;

Standard 2: Pharmacists and pharmacy technicians must establish and maintain professional relationships with their patients.

2.3 Each pharmacist and pharmacy technician must deal directly with the patient unless:

  1. it is in the best interest of the patient for the pharmacist or the pharmacy technician to deal with the patient’s agent, or
  2. the pharmacist is satisfied that a regulated health professional acting within the scope of their profession is responsible for the administration of drugs to the patient.

Standard 3: Pharmacists must consider appropriate information for each patient.

3.3 A pharmacist who delays an assessment under Standard 3.2 must ensure that appropriate  information to assess the patient and the patient’s health history and history of drug therapy is completed each time a new prescription or drug order is received, or every 90 days, whichever comes first.

Standard 8: Each time a pharmacist or a pharmacy technician dispenses a Schedule 1 drug or blood product pursuant to a prescription, or sells a Schedule 2 drug:

  1. the pharmacist or the pharmacy technician must confirm the patient’s identity, and
  2. a pharmacist must provide the patient with sufficient information to enable the patient to receive the intended benefit of the drug therapy.

8.3 A pharmacist must enter into a dialogue with a patient:

  1. when a Schedule 1 drug or blood product is dispensed to the patient for the first time;
  2. when a Schedule 2 drug is sold to the patient for the first time;
  3. if the patient requests information; and
  4. if, in the pharmacist’s professional opinion, a dialogue is required to:
    1. provide the patient with sufficient information to enable the patient to receive the intended benefit of the drug therapy; or
    2. avoid, resolve, or monitor a drug therapy problem.

8.4 Despite Standards 8.1 to 8.3, a communication or dialogue with a patient may not be required if the drug being dispensed or sold will only be administered by or under the supervision of a regulated health professional acting within the scope of their profession.

Standards for the Operation of Licensed Pharmacies

Standard 5: A licensee must ensure the drug supply in the licensed pharmacy is managed so as to protect the integrity, quality and safety of drugs, health care products, aids and devices.

5.5 A licensee must ensure that appropriate conditions are maintained to ensure the integrity and security of the drugs when drugs are packaged in or transported from a licensed pharmacy.

5.9 A licensee must ensure that drugs are kept in the appropriate locations within the prescription department, having regard for their scheduling under Part 4 of the Pharmacy and Drug Act.

Standard 8: A licensee must ensure that there is an effective system for the creation, maintenance, secure storage and availability for retrieval of all required records.

8.1 The licensee must ensure that there is an effective system for the creation, maintenance, secure storage and availability for retrieval of all required records, including but not limited to:

  1. records of the mode of delivery of a drug to a patient for all drugs that are not picked up at the pharmacy by the patient or the patient’s agent.

Standard 10: A licensee of a mail order pharmacy must establish and monitor compliance with policies and procedures and keep appropriate records of activities related to the provision of mail order pharmacy services.

10.1 The licensee of a mail order pharmacy must:

  1. establish policies and procedures regarding how information is collected to assess individual patients and obtain all the information necessary to allow the regulated members to meet the requirements of the Standards of Practice for Pharmacists and Pharmacy Technicians, and
  2. ensure compliance with these policies and procedures via regular monitoring. Record keeping requirements in a mail order pharmacy

10.2 In addition to the records that must be kept in a community pharmacy, a mail order pharmacy must keep records that identify any arrangement or agreement under which patients are referred to the mail order pharmacy