Scope of Practice – Pharmacists Practice Topic

From a scope of practice perspective, a pharmacist may conduct a comprehensive medication review for a patient according to the Standards of Practice.

Establishing the MedsCheck program eligibility criteria for patients and pharmacists falls under the mandate of the Ministry of Health. Information related to billing, such as submitting a claim for reimbursement and the required paperwork, can be found in the materials available on the Ministry of Health website, such as the Professional Pharmacy Services Guidebook, and the Ontario Pharmacists Association’s MedsCheck Resources. Additional questions can be directed to the ODB HelpDesk or [email protected].

For example, the Ministry of Health may require the pharmacist to meet certain education requirements to be eligible to receive reimbursement for providing a Ministry of Health professional service program. As pharmacists are self-regulated professionals, the College cannot interpret the Guidebook on behalf of a registrant and/or determine whether the Ministry’s criteria have been met.

As explained in the Pharmacist Prescribing: Initiating, Adapting and Renewing Prescriptions Guideline, pharmacists have the independent authority to initiate treatment for smoking cessation with buproprion or varenicline under O. Reg 256/24 of the Pharmacy Act. 

The regulations do not require a pharmacist to complete specific training prior to initiating treatment for smoking cessation. Similarly, OCP does not require or endorse a particular program you may wish to take. As with any patient care scenario, pharmacists are relied upon to practice within the limits of their competence, and to obtain the knowledge and skills necessary to carry out their professional duties. 

However, you may be required to complete a certification course for the purposes of obtaining reimbursement for providing a specific smoking cessation service offered through a patient’s third-party insurer or the Ministry of Health. 

It is the professional responsibility of a pharmacist to self-assess their competency and ensure they possess sufficient knowledge, skills and judgment to safely dispense any medication. A pharmacist is expected to undertake education or training as necessary to address any knowledge gaps so that they are able to effectively assess the patient and evaluate the appropriateness of the prescribed therapy. Pharmacists are reminded that they are responsible for providing the patient with relevant and sufficient information about the medication, including how to manage potential risks associated with use, and for providing appropriate follow-up. Given the serious safety concerns identified with the use of Mifegymiso®, pharmacists should report any cases of serious or unexpected side effects to Health Canada’s MedEffect Canada adverse reaction reporting system or to the manufacturer. Additional resources are available on the Linepharma website. Also, the Canadian Pharmacists Association has published a checklist for pharmacists and the Society of Obstetricians and Gynecologists of Canada offers a training program. 

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 256/24. Vaccines (listed in Schedule 3 of the regulation) may be administered under independent authority in accordance with the Administering a Substance by Injection Guideline. 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. 

Pharmacy professionals may dispense or compound drugs pursuant to a prescription issued by a veterinarian for an animal, provided they have the knowledge and skills to do so safely and in accordance with the Standards of Practice. The Drug and Pharmacies Regulation Act (which governs dispensing and compounding by pharmacy professionals) defines ‘prescription’ as “a direction from a prescriber for the dispensing of any drug or mixture of drugs for a designated person or animal.” Importantly, the patient is the animal, not the owner/client, and collaboration between veterinarians and pharmacists is essential for the safety of their animal patients when providing these services. 

However, it is important to recognize that additional factors are necessary to consider since the use of a drug in humans cannot be equated to the use of the same drug in animals¹. Differences in the anatomy and physiology of animals can result in differences in a drug’s pharmacokinetic and pharmacodynamic properties and species-specific toxicities. The provision of care to animals requires specialized training and knowledge, and pharmacists have a professional responsibility to acknowledge when they lack sufficient competency to provide this service. 

Other professional pharmacy services, such as prescribing (I.e., initiating, adapting, and renewing prescriptions) or administering substances, are governed by the Pharmacy Act. Regulations under this act define ‘prescription’ as “a direction from a prescriber directing the dispensing of a drug or mixture of drugs for a specific patient” without including ‘animal’. It presents a significant risk to animals for a pharmacist to provide care beyond the dispensing or compounding of a veterinary prescription. As such, the regulations that include these services in a pharmacist’s scope of practice, such as the recent change permitting prescribing for minor ailments, apply only to human patients. 

Reference 

1. Similar, But Different: Veterinary and Human Drugs Pharmacy Connection Article

The regulations require a pharmacist to notify “the patient’s primary care provider (if any) within a reasonable time” that they prescribed a drug for the patient. If there is no primary care provider to notify at this time, this information is retained on the patient record in accordance with legislation and must continue to be accessible to the patient and their circle of care. 
 
As the prescriber, the pharmacist is responsible for monitoring and follow-up on the treatment plan and prescribed therapy, essentially assuming the role of primary care provider until the patient’s care can be transitioned, if necessary, to another healthcare professional. 

Yes. A pharmacy professional may decide to administer a substance that is not listed in Schedule 2 of O. Reg. 256/24 to a patient via the intranasal route, without needing delegation of authority (e.g., a medical directive). Refer to Appendix A of the Administering a Substance by Inhalation Guideline as it explains that “intranasal” administration of a substance is not a controlled act and therefore is not restricted to health professionals or require enabling regulations. 

With inhalation, the drug is intended to be delivered to the epithelium lining the lower respiratory tract. With intranasal administration, the drug is intended to be delivered to the mucous membranes lining the nasal passages. If a pharmacy professional decides to administer a substance by the intranasal route, this should still be done in accordance with the Administering a Substance by Inhalation Guideline, Code of Ethics and Standards of Practice. 

Yes. Administering a substance by injection is a “controlled act”, as defined in the Regulated Health Professions Act (RHPA), that may only be performed by an authorized health professional. There are, however, provisions in the RHPA that permit “a person” to perform a controlled act “in the course of rendering first aid or temporary assistance in an emergency” even if they are not an authorized health professional. 

Also, the province’s Good Samaritan Act provides protection from liability for a pharmacy professional “who provides emergency health care services or first aid assistance to a person who is ill, injured or unconscious as a result of an accident or other emergency”. 

Therefore, in the event of a medical emergency, a pharmacy professional may decide to administer a substance (that is not listed in Schedule 1 of O. Reg. 256/24) to a person, without delegation of authority (e.g., a medical directive), while waiting for emergency medical services. This should still be done in accordance with the Administering a Substance by Injection Guideline, the Code of Ethics and Standards of Practice. 

Having a degree in pharmacy is one of several requirements needed for a certificate of registration, in order to practice as a licensed pharmacist in Ontario. It does not, in itself, confer the right to practice pharmacy. Should an individual wish to make reference to their educational credentials, this information should be presented in a manner that is not ambiguous, confusing, or misleading to the public. OCP has not established any additional policy or guideline restricting how a degree or credential may be used, however, it must be evident whether an individual is licensed by the College and able to practice pharmacy, or not.

Pharmacy graduates who possess a PharmD (Doctor of Pharmacy) degree should be aware that use of the title “Doctor” (or an equivalent abbreviation, such as Dr.) is restricted by the Regulated Health Professions Act, Section 33. A pharmacist cannot use this title in the course of providing, or offering to provide, health care to an individual. The regulated health professionals who may use this title in practice are defined in the Act. Pharmacists should be mindful when referring to their PharmD degree of the potential for misinterpretation by a patient that the individual is, for instance, a Medical Doctor (MD).

Once registered with the College as a pharmacist, they are permitted to use the title of “Pharmacist” or an equivalent abbreviation, such as the designation “RPh” (approved by Council in 2003). Section 10 of the Pharmacy Act also restricts the use of the titles “Apothecary” and “Pharmaceutical Chemist” to registered pharmacist registrants of the College. Similarly, “Pharmacy Technician” (and its abbreviation RPhT) became a restricted title under the Pharmacy Act in December 2010. All other titles – such as Certified Pharmacy Technician (in use prior to 2008) – must no longer be used. This does not prevent someone from indicating their past achievement of passing the College’s certification exam, such as on a résumé, however the title of “Pharmacy Technician” cannot be used in practice unless they are registered as registrants of the College.

These are two distinct factors which must be considered independently in a scenario where the pharmacy professional is both dispensing and administering a substance.

“Schedules” are included in legislation to provide details (such as lists and tables) that aren’t suitable for including in the main content of the Act or Regulation. There are four schedules in O. Reg. 256/24 under the Pharmacy Act:

• Schedule 1: Injected substances
• Schedule 2: Inhaled substances
• Schedule 3: Vaccines
• Schedule 4: Drugs — minor ailments

In terms of scope of practice, pharmacists are authorized to administer a substance in Schedule 1 by injection, a substance in Schedule 2 by inhalation, or a vaccine in Schedule 3. (Schedule 4 relates to pharmacist prescribing and not to administration.)

Separately and distinctly, O. Reg. 264/16 under the Drug and Pharmacies Regulation Act requires pharmacies to follow the conditions of sale for a drug according to the NAPRA National Drug Schedules:

• Schedule I: Drugs require a prescription; only available from the dispensary
• Schedule II: Drugs do not require a prescription but do require intervention from the pharmacist; available from an area of the pharmacy where there is no opportunity for patient self-selection
• Schedule III: Drugs do not require a prescription, but a pharmacist or intern must be available for consultation; available for self-selection from the professional products area (within 10m/30ft of the dispensary)
• Schedule U: Drugs do not require a prescription or professional supervision; available from any retail outlet

For additional information please refer to:

• Pharmacy Connection Article: Navigating Drug Scheduling in Ontario
• NAPRA NDS Update on Clarification of Vaccine Scheduling in the National Drug Schedules