Frequently Asked Questions from Pharmacy Practice


FAQ logoNote that these answers were current at date of publication and are meant as guidance for pharmacy professionals. The College cannot tell a member what course of action to take, provide legal advice or opinions, or make any decisions for a member.


MEDICAL DIRECTIVES

Q: When processing a prescription written by someone who has been given a medical directive, is the physician listed as the prescriber or would it be the healthcare practitioner who has been designated?

ANSWER
The prescriber should indicate who is ultimately responsible for the prescription. The College’s Policy – Medical Directives and the Delegation of Controlled Acts explains that “When delegating an act or procedure, the authorizer is responsible for ensuring that the act is performed competently…Accountability for the delegated act remains with the authorizer…”

The Federation of Health Regulatory Colleges of Ontario (FHRCO) has developed an Interprofessional Guide on the Use of Orders, Directives and Delegation for Regulated Health Professionals in Ontario which contains a template for a Recommended Format for a Prescription or Requisition Completed Pursuant to a Directive. The Pharmacy Connection article Physician Assistants (Fall 2014) may also be of interest.


Vaccines

INJECTIONS

Q: I have been contacted by a doctor’s office to inject [specified vaccine] into one of their patients. Are we allowed to inject it without a medical directive?

ANSWER
Please refer to the Guideline on Administering a Substance by Injection or Inhalation.

Since October 2012, pharmacists have been authorized to administer the influenza vaccine through the Ministry’s UIIP, and to administer a substance specified in the regulation to a patient who has been prescribed a self-administered injection for the purpose of education and demonstration. (Refer to Schedule 1 in O. Reg 202/94 to the Pharmacy Act for a list of these substances). In December 2016, the regulations were amended to allow for the administration of additional vaccines, found in Schedule 3 of O. Reg 202/94.

Situations outside of the pharmacist’s scope of practice as defined in the legislation (i.e. substances not listed in the regulations, or not for the purposes of education and demonstration) would require delegation of authority, such as a medical directive.

Pharmacists who have completed the appropriate training and feel they have sufficient skills and knowledge to perform other injections may wish to explore collaboration with other health care providers to do so. Please refer to the Policy on Medical Directives and the Delegation of Controlled Acts.


Q: We had a patient come into the pharmacy and ask the pharmacist to “prescribe” a vaccine. If the patient has a drug plan that pays for the vaccine can the pharmacist write the prescription and administer the vaccine? We were wondering if this would be similar to how we bill publicly-funded flu shots.

ANSWER
Billing a prescription to a third party payer does not have any bearing on the scope of practice of pharmacy defined by the Pharmacy Act and Ontario Regulation 202/94 – General. Vaccines (listed in Schedule 3 of the regulation) may be administered under independent authority in accordance with the Guideline – Administering a Substance by Injection or Inhalation. Vaccines listed in Schedule I of the NAPRA Drug Schedules require a valid prescription in order to be dispensed prior to administration.

To receive reimbursement for influenza, which is a Schedule II vaccine, a claim is submitted to ODB via the Health Network System. This requires the pharmacist to enter information similar to that of a prescription, with the pharmacist’s identification in the ‘prescriber’ field (refer to the Ministry of Health and Long- Term Care’s Executive Officer communications). As this is a billing mechanism (which also creates documentation for the patient) it should not be interpreted as prescribing the vaccine, as pharmacists do not have the independent authority to do so.


STERILE COMPOUNDING

Q: What are the specific requirements for the accreditation and operation of a compounding pharmacy that makes sterile preparations? Is there a list of required courses and equipment approved by the College?

ANSWER
The College does not issue a separate certificate accreditation for pharmacies compounding sterile preparations. All community pharmacies, regardless of the specific services provided, must meet the minimum standards for accreditation as set out in the Drugs and Pharmacies Regulation Act and in the College’s Accreditation and Operation of a Pharmacy – Guidance for Pharmacy Professionals. Pharmacy professionals engaging in sterile compounding have additional standards to meet, namely the Model Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations (NAPRA) and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations (NAPRA) adopted by Council for implementation by January 1, 2019.

The College does not approve or endorse training programs, equipment, vendors, etc. or maintain a list of companies that offer products for sterile compounding. It is the responsibility of the Designated Manager to source the appropriate resources to meet the standards.

If changes will be made to the accredited area of an existing pharmacy, please follow the instructions for Pharmacy Renovations available on the OCP website. For new pharmacies, there is a section on the application to indicate which specialty services the pharmacy plans to offer. This information does not appear on the public register, however it is necessary to determine the frequency of pharmacy assessments. All community pharmacies undergo routine assessments every one to four years, depending on the activities performed at the pharmacy and the risk of harm those activities pose to the public. Therefore, to help the College fulfill its mandate to protect the public, a pharmacy engaged in sterile compounding will be assessed more often than a pharmacy that does not.