Home Practice & Education Practice Tools Frequently Asked Questions – Pharmacy Practice

Frequently Asked Questions – Pharmacy Practice

The College produces FAQs to support pharmacists and pharmacy technicians in certain aspects of practice. FAQ sets are chosen based on questions that we receive most frequently.

Disclaimer: Note that these answers were current at date of publication (as noted in each answer) and are meant as guidance for pharmacy professionals. The College cannot tell a registrant what course of action to take, provide legal advice or opinions, or make any decisions for a registrant.

Pharmacists are considered to be medication experts and are often the most accessible healthcare providers for patients. Ontarians who consume or are considering consuming cannabis should expect their pharmacist to have the knowledge to help them make the best decisions about their care and to be able to effectively respond to their cannabis-related inquiries.

In addition to the opportunity to provide advice on cannabis use, there is also an opportunity to educate the public on harm prevention strategies to reduce possible risks associated with cannabis consumption and to identify and assist patients who are at risk of cannabis use disorder. Also, as a patient could acquire recreational cannabis without the intervention of a health professional and intend to consume it for medical purposes, pharmacists are in an ideal position to support patients in such circumstances.

Do I need to ask all my patients about their cannabis use?

Pharmacists are expected to gather relevant information through dialogue with the patient to assess the appropriateness of a prescribed medication and to identify potential drug interactions. This may include asking about allergies, medical conditions, and lifestyle factors, such as the patient’s diet, alcohol, exercise, tobacco, and cannabis consumption.

As medication experts, pharmacists are in a unique position to support patients who consume cannabis, collaborating with other health care professionals as needed, to promote patient safety while striving to meet their health goals and desired treatment outcomes.

Can community pharmacies dispense cannabis or include a patient’s medical cannabis in their blister pack?

No. Under the federal Cannabis Act, the Access to Cannabis for Medical Purposes Regulations prohibit pharmacies (or any retail outlet) from dispensing cannabis for medical purposes.
A pharmacist cannot alter or repackage cannabis, or be responsible to obtain, possess, or distribute cannabis on behalf of a patient.

The holder of a federal license for sale for Cannabis for Medical Purposes must deliver directly to the patient, by mail and in the licensed processor’s original packaging, pursuant to an order from a health care practitioner.

Cannabis for recreational or non-medical purposes can only be distributed or sold through the online Ontario Cannabis Store or through privately run retail stores that have received a license from the Alcohol and Gaming Commission of Ontario.

Community pharmacists are not exempt from the methodologies of distribution of cannabis outlined in the legislation. For additional information, please contact Health Canada’s Cannabis Legalization and Regulation Branch (CLRB) at cannabis@canada.ca.

Can a patient bring their own cannabis to a pharmacist to have it compounded into a capsule or a cream?

No. Under the federal Cannabis Act, activities with cannabis are prohibited unless authorized by the Cannabis Regulations. It is prohibited to obtain, or offer to obtain cannabis by any method or process, including altering its chemical or physical properties. Any compounding activity involving cannabis would require enabling regulations or an exemption from the application of the Act by the Minister under subsection 140(1).

For additional information, please contact Health Canada’s Cannabis Legalization and Regulation Branch (CLRB) at cannabis@canada.ca.

CONTROLLED SUBSTANCES, BUPRENORPHINE, METHADONE

Sometimes I get a prescription for a controlled substance that is not available in the Canadian market (e.g. a prescription for hydromorphone 0.5 mg, 60 tablets, where only hydromorphone 1mg is available). Considering this scenario, am I able to dispense half of the prescribed quantity (e.g. 30 tablets) while breaking the 1mg tablet in half?

Published in the Pharmacy Connection Winter 2018 edition.

There may be more than one way to dispense a prescription to ensure the patient receives the correct drug, dose and total quantity, such as in the situation you describe. The College cannot provide a specific answer on the action the pharmacist should take; it is the registrant’s responsibility to assess the prescription and decide the best course of action based on all the information at their disposal.

In situations where a specific dose or strength indicated on a prescription does not exist, is unavailable, or is not the most appropriate option for the patient, the pharmacist, in exercising their professional judgment, may choose to use available dosage forms to make up the prescribed strength/dose. Alternatively, the pharmacist may choose to contact the prescriber for clarification — either in writing or verbally — when presented with a prescription that is ambiguous or the intent of the prescriber is not clear.

Depending on the specific scenario, it may be important to ascertain if there was a clinical reason for prescribing a particular strength or dosage form. If there are different options, what does the patient prefer? Or, if the drug does not exist in a given strength, is it possible an error was made in the name of the drug or the dose?

When deciding whether or not it is appropriate to split the tablets prior to dispensing, pharmacy professionals should apply their knowledge to determine whether or not the medication is amenable to splitting (e.g. scored or not, accuracy of resulting dose, stability, tablet integrity) and keep the patient’s health outcomes, best interest and safety in mind.

Documentation of one’s rationale is important, in addition to documentation of dialogue with the patient, their understanding of the changes, and their informed consent. Pharmacy professionals are encouraged to reach out to their peers for timely guidance with practice-related questions as well, to leverage their practical experience and get advice on how they approach situations like this, assess the prescription, and exercise professional judgement.

Can we accept prescriptions for methadone for MMT from out of province clinics/prescribers?

Published in the Pharmacy Connection Fall 2017 edition.
*August 2022: The Fact Sheet – Out of Province Prescriptions has been incorporated into the Cross-Jurisdiction Pharmacy Services Policy

Pharmacy professionals who accept prescriptions for any drug from an out of province prescriber should refer to OCP’s Fact Sheet on Out of Province Prescriptions*. In addition, pharmacists should be familiar with OCP’s Opioid Policy prior to dispensing any methadone prescriptions.

Pharmacists should have and refer to the required reference Opioid Agonist Maintenance Treatment: A Pharmacist’s Guide to Methadone and Buprenorphine for Opioid Use Disorder (CAMH). Collaboration with the prescriber may be required to ensure methadone prescriptions are written in accordance with Ontario MMT policies as well as the Narcotic Safety and Awareness Act requirements. If a pharmacy professional is unsure of the scope of practice and prescribing authority of another regulated health professional, they should contact the individual’s regulatory body for clarification.

We have a patient who has been prescribed methadone for pain management. What do we need to have in place before we can dispense this prescription?

Published in the Pharmacy Connection Summer 2019 edition.

The College’s Opioid Policy sets out expectations for pharmacists dispensing all opioids, which includes methadone for pain or analgesia.

Pharmacists should adhere to the most recent clinical practice guidelines and the appropriate standards of practice to ensure best patient outcomes for individuals on opioid therapy. The Opioid Practice Tool provides easy access to numerous resources to support pharmacy professionals in safe opioid dispensing, including the 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain.

I have received a prescription for buprenorphine/naloxone. Can I dispense it, or do I need to have specific training first?

Published in the Pharmacy Connection Summer 2019 edition.

Guidance from the College with respect to buprenorphine/naloxone dispensing for Opioid Agonist Treatment (OAT) can be found in the Opioid Policy. This includes practicing in accordance with CAMH’s Opioid Agonist Maintenance Treatment: A Pharmacist’s Guide to Methadone and Buprenorphine for Opioid Use Disorder.

Additional resources are available in the Methadone and Buprenorphine Practice Tool and practitioners can access the CRISM National Guideline for the Clinical Management of Opioid Use Disorder via the Opioid Practice Tool.

Although the Opioid Policy does not mandate formal training as a prerequisite for dispensing buprenorphine/naloxone, the College lists Continuing Education opportunities on the OCP website as a tool to assist with professional development.

As with any medication, pharmacists are relied upon to ensure they have the necessary knowledge, skills and judgment to provide OAT in a safe and effective manner.

Does our pharmacy need to notify the College that we are dispensing methadone and/or buprenorphine/naloxone?

Published in the Pharmacy Connection Summer 2019 edition.

The College’s Opioid Policy specifies that pharmacists dispensing methadone for Opioid Agonist Treatment (OAT), also known as methadone maintenance treatment (MMT), must be in compliance with the Fact Sheet: Key Requirements for Methadone Maintenance Treatment (MMT) Dispensing, which states:

“Community pharmacies must inform the College within seven days of starting to dispense MMT and of any changes in this information, using the approved Methadone Dispensing Notification Form.”

Notification is required to help the College fulfill its mandate to protect the public. All 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. A community pharmacy dispensing methadone will be evaluated according to the operational assessment criteria more often than a pharmacy which does not.

Pharmacies dispensing methadone as an opioid analgesic for pain or buprenorphine/naloxone are not required to notify the College.

DISPENSING PRESCRIPTIONS

When a prescription is received or issued under delegation, such as a medical directive, who is the prescriber on the dispensing record – the prescriber or the person who signed it?

The Regulated Health Professions Act has provisions to allow a regulated health professional to delegate their authority to perform a controlled act to a person (regulated or not) who does not have that authority. Delegation of authority can be implemented by use of a Direct Order or a Medical Directive. In this case, the controlled act is “prescribing”.

The OCP Policy- Medical Directives and the Delegation of Controlled Acts sets out the expectations for registrants who are considering authorizing or implementing delegated acts.

A prescription issued pursuant to a directive must include the:

Name of prescriber (delegator; authorizer of the directive)
Name and signature/unique authorization of the person issuing the prescription (delegate; implementer of the directive)
Name and number of the medical directive
Contact information for the authorizer and implementer

The prescriber’s name should be recorded on the dispensing record as they are ultimately responsible for the prescription, even though they have delegated the authority to perform the act to someone else to implement via a directive.
Should there be questions about the prescription, registrants should contact the implementer. If the questions cannot be resolved, the prescriber would be contacted for clarification. Where requested, a copy of the directive may also be forwarded to the pharmacy.

More information can be found in the Health Professions Regulators of Ontario (HPRO) Interprofessional Guide, FAQ, and templates such as the Recommended Format for a Prescription or Requisition Completed Pursuant to a Directive.

I have a question regarding a prescription from a Naturopathic Doctor from British Columbia. The prescription is for a medication that Naturopathic Doctors in Ontario cannot prescribe. Can I dispense it?

Published in the Pharmacy Connection Fall 2018 edition.
*August 2022: The Fact Sheet – Out of Province Prescriptions has been incorporated into the Cross-Jurisdiction Pharmacy Services Policy

The College does not maintain information on the scope of practice of practitioners other than pharmacy professionals in Ontario. Questions about the scope of practice and prescribing authority of another health professional should be directed to their regulatory body. Collaboration with the practitioner is also encouraged, as self-regulated health professionals should be aware of – and practicing within – their legal scope of authority and the policies and guidelines of their College. This topic was covered in the Summer 2017 Pharmacy Connection article Prescriptions from Other Healthcare Professionals.

The Fact Sheet – Out of Province Prescriptions* explains that dispensers may accept a prescription written by a prescriber licensed in any province or territory of Canada. The Drug and Pharmacies Regulation Act (DPRA) defines “Prescriber” as “a person who is authorized under the laws of a province or territory of Canada to give a prescription within the scope of his or her practice of a health discipline”. An out-of-province prescriber is registered and regulated by their province’s (or territory’s) health disciplinary college. Therefore, the regulations and corresponding scope of practice of the same health discipline in Ontario cannot be applied to an out-of-province practitioner. Similarly, a pharmacist licensed in another province whose scope includes prescribing authority (for example, to initiate treatment for minor ailments or to renew a prescription) is considered a prescriber for the purposes of the Act.

We received a prescription with a statement that it was electronically signed by the prescriber but there is no actual signature on it. What are the regulations around this?

Published in the Pharmacy Connection Winter 2020 edition.

The requirements for a prescription to be “signed” are established in the federal regulations relevant for the schedule of the drug. There is nothing in the regulations mandating the use of a “wet” signature. As explained in the related 2014 article, Navigating Electronically Generated Prescriptions, “Health Canada has broadly defined ‘signing’ as whatever is determined to be necessary to authorize and validate the order”.

The College’s Position Statement Authenticity of Prescriptions using Unique Identifiers for Prescribers (July 2013) describes three examples of distinct authorization methods:

a traditional pen-and-ink signature, or
an electronically captured image of a unique signature (generated on a signature pad), or
a unique prescription authorization process which ensures that the prescriber has reviewed and authorized each individual prescription

There may be many different technologies available to prescribers, especially as computerized order entry and electronic prescriptions become increasingly common, to implement a unique authorization process and generate an order without an actual image of a signature.

Dispensers should review the Position Statement in its entirety, especially the guidance provided in the section “The Responsibility of the Registrant”. If the pharmacist decides that they need to verify the authenticity of the order, this may be done verbally or in writing (via fax). Prescribers should seek guidance from their regulatory College.

Should pharmacists wear PPE when dispensing medications?

The following FAQ was provided by Public Health Ontario.

COVID-19 is transmitted via droplets during close, unprotected exposure, and when in direct contact with surfaces and fomites that have been recently contaminated with the virus. Studies have documented the presence of virus on surfaces in the environment of patients who have tested positive for COVID-19 however the relative importance of indirect contact transmission (i.e. droplets spreading from a patient to an environmental surface to another individual) is uncertain. For further details please refer to PHO’s What we know so far about…COVID-19 Transmission Through Large Respiratory Droplets and Aerosols.

In the proposed scenario, the pharmacist/pharmacy technician or assistant is asymptomatic and is preparing non-sterile, non-hazardous medications using proper equipment/procedures in the absence of close contact with patients or other pharmacy staff. The risk of contaminating the medication and/or medication container and then subsequent transmission to patients consuming the medication would be very low, especially with proper hand hygiene, environmental cleaning and equipment disinfection processes in place. The use of PPE is unlikely to further reduce risk for routine medication preparation in this scenario. However, where there is a requirement for universal masking in publicly accessible spaces, the pharmacist/pharmacy technician may need to wear a mask depending on where the medication preparation space is located.

We have been receiving emailed prescriptions from prescribers, and sometimes prescribers are emailing prescriptions directly to their patients. Are these emailed prescriptions valid for dispensing? How should we handle these situations?

Regular e-mail (as opposed to a secure healthcare portal) is not a secure medium for prescription transmission.¹ In addition to cybersecurity risks, when a prescriber e-mails a prescription directly to a patient, it increases the likelihood of fraud and duplication of the prescription. Therefore, unsecured email is not an acceptable mechanism for transmitting prescriptions, especially for monitored drugs and those listed under the Controlled Drugs and Substances Act (CDSA).

Upon receiving a prescription via unsecured email, pharmacists are encouraged to contact the prescriber to verify its authenticity and collaborate with them and the patient to determine the best method of transmitting a prescription from the prescriber directly to the pharmacy via established channels (e.g., fax, verbal confirmation, secure electronic transmission).

There may be times when a pharmacist needs to use their professional judgement when accepting an e-mailed prescription – for example, when a prescriber cannot be reached and the patient is at risk of going without necessary medication. In these cases, pharmacists should exercise their professional judgment in determining whether to dispense the prescription and follow-up with the prescriber at the earliest available time. Prescribers should also seek guidance from their regulatory College.

Reference

1. Information and Privacy Commissioner Ontario. Privacy Protection Principles for Electronic Mail Systems (1994). Retrieved at https://www.ipc.on.ca/wp-content/uploads/2016/09/Health-Fact-Sheet-Communicating-PHI-by-Email-FINAL.pdf.

Can pharmacy professionals accept verbal prescriptions phoned in by someone calling on behalf of the prescriber (e.g., nurse, pharmacist, administrative assistant)?

Yes. Pharmacy professionals are authorized to accept verbal prescriptions under federal regulations. The regulations outline what practitioners can order verbally and the details which must be included on the written record of the transcribed prescription. However, the regulations do not address the workflow or operational aspects that might be encountered in practice.

Regardless of who performs the ‘task’ of phoning in the prescription, the receiving pharmacy professional is responsible for determining that it is valid and authentic. If there is uncertainty about whether a practitioner with prescribing authority has truly initiated and authorized the order (being communicated via an intermediary), the pharmacy professional should follow up with the prescriber directly. The decision as to what is sufficient to verify the legitimacy of the prescription, considering the circumstances at hand and the best interest of the patient, rests with the professional judgement of the registrant who should document their rationale.

Pharmacy professionals should be especially diligent when receiving verbal orders due to the increased potential for errors.^[1] Prescribers should consult their regulatory body for guidance on issuing verbal prescriptions.

1. Refer to: https://www.ismp-canada.org/download/safetyBulletins/2020/ISMPCSB2020-i4-TelephoneOrders.pdf

DOCUMENTATION, RECORDKEEPING & PRIVACY

I received a summons from another regulatory body requesting patient identifying information for an investigation. Is there any requirement on my part to obtain patient consent to release this confidential information?

Published in the Pharmacy Connection Summer 2018 edition.

Please refer to the Fact Sheet — Releasing Personal Health Information, which describes a few of the more common disclosures permitted by health information custodians, which pharmacists are, under the Personal Health Information Protection Act (PHIPA). You can also to refer to the legislation directly for complete details or contact the Information and Privacy Commissioner of Ontario.

Regarding requests from health regulatory colleges in Ontario, all colleges – including OCP – must follow the same Health Professions Procedural Code (set out in the Regulated Health Professions Act). Colleges also establish Rules of Procedure, as any hearings in Ontario must meet the standard for procedural fairness mandated by the Statutory Powers Procedure Act. You could reach out to the investigator directly regarding questions about their rules of procedure.

Specific to fentanyl, please refer to the Patch-For-Patch Fentanyl Return Program: Fact Sheet. Regulation 305/16 under the Safeguarding Our Communities Act (Patch for Patch Return Policy) has specific provisions for dispensers providing information to law enforcement. Please refer to section 4(3) under ‘Contingency Plan’ in the regulations.

Additional Resource

Quick Links to the Office of the Information and Privacy Commissioner of Ontario

I am closing my pharmacy and need to transfer patient files. However, I am uncertain of the rules pertaining to narcotics and controlled substances; would patients be required to get a brand new prescription for all narcotic and controlled medication, or is there a system in place for moving these items, recognizing that there are no "transfers" of narcotic and controlled substances, except benzodiazepines?

Published in the Pharmacy Connection Summer 2018 edition.

When closing a pharmacy, the patient files and prescription records are “transferred” or relocated to the receiving Designated Manager (DM)/owner, and the prescriptions will then belong to the receiving pharmacy. Exactly “how” the records are entered or merged into the receiving pharmacy’s software system is sorted out by the DMs and the vendor(s). Ideally, it should be seamless to the patient.

This “transfer of records” process is not the same as a prescription transfer (as permitted by the Drug and Pharmacies Regulation Act) from one accredited pharmacy to another at the patient’s request, where transfer of narcotics and controlled prescriptions is prohibited by federal regulations.

Pharmacies and pharmacy professionals participating in the closure of a pharmacy should review the College’s Closing a Pharmacy webpage. Additionally, the College’s Guideline on Record Retention, Disclosure and Disposal can provide additional information on the management of patient records.

When can I disclose personal health information?

The College’s Fact Sheet — Releasing Personal Health Information describes some of the most common disclosures permitted by pharmacists/pharmacies as health information custodians under Ontario’s PHIPA. For example, information may be disclosed when a pharmacy professional is presented with a warrant, court order, production order, or under authority established in legislation, such as the Coroners Act and the Missing Persons Act. There may be other legislation—such as Canada’s Criminal Code or the province’s Child, Youth and Family Services Act— which may prevail over PHIPA.

The Information and Privacy Commissioner of Ontario, who provides oversight of Ontario’s access and privacy laws including PHIPA, has additional resources to guide registrants in their decisions surrounding personal health information, including:

As always, supporting documentation is essential as evidence of your decision-making process and rationale. If a registrant is uncertain about their obligations after reviewing the appropriate resources and legislation, they may wish to obtain independent legal advice or consult with their corporation’s privacy officer.

Can we give the details of a deceased patient’s profile to family members, including medical history and medical expenses for tax purposes?

Published in the Pharmacy Connection Fall 2019 edition.

Pharmacies and pharmacy professionals in Ontario have responsibilities to safeguard the personal health information of their patients as health information custodians under the Personal Health Information Protection Act (PHIPA). One of the additional resources on the OCP website is called Quick Links to the Office of the Information and Privacy Commissioner of Ontario (IPC). These resources have been selected to assist registrants in understanding their obligations under PHIPA, such as the Fact Sheet #15 –Obtaining Personal Health Information About a Deceased Relative. Additional information can be found on the IPC website.

Our community pharmacy has original prescriptions and hard copies dating back to before we started scanning. How long do we need to keep these?

Published in the Pharmacy Connection Fall 2019 edition.

Please refer to the Guideline — Record Retention, Disclosure, and Disposal and the Fact Sheet – Record Keeping and Scanning Requirements.

Regulations under the Drug and Pharmacies Regulation Act (DPRA) require pharmacies to make and retain a scanned copy of all original prescriptions. All prescription records in the pharmacy’s possession, scanned or in hardcopy form, are subject to the retention period of a minimum 10 years after the last date of service provided to the patient.

Since records cannot be destroyed until at least 10 years after the patient has ceased to use a pharmacy’s services (notwithstanding the provision for children under 18 years of age), the date of when a record can be destroyed cannot be pre-determined. If the patient continues to use the services of the pharmacy, the patient record would need to be retained on file for an indefinite period of time (i.e. forever).

Also, the patient record must be maintained as a whole, therefore dispensing records (hard copies) and prescriptions (originals or scanned originals) cannot be singled out for destruction. The decision to destroy paper based records after they have been scanned is at the discretion of the Designated Manager who should evaluate the backup processes in place to safeguard records for the required timeframe.

When checking prescriptions, can students enrolled in an educational program to become a pharmacist or pharmacy technician sign the prescription dispensing record?

Yes. The Drug and Pharmacies Regulation Act (DPRA) s149 permits pharmacy students and pharmacy technician students under direct supervision of a Part A pharmacist who is physically present, to perform their respective therapeutic and/or technical checks to dispense prescriptions. Students should document their actions, reflecting which step(s) of the process they performed and are responsible for, on the dispensing record.

The College does not require a specific documentation method or format for “signing” a prescription by the student or the supervising pharmacist. This depends on the software, technology, and workflow in place, which differs between pharmacies. As with any activity performed by a student, there must be a way to readily identify the supervising pharmacist who is responsible and accountable for the student. The Designated Manager/pharmacy administrator should establish expectations and operational procedures on documentation to support students and supervising pharmacists. Refer to the Supervision of Pharmacy Personnel Policy for more information. Consideration should be given to situations outside of the College’s mandate, such as third-party billing and audits. Students should consult their educational institutions for guidance on documentation during experiential learning.

GENERAL PHARMACY PRACTICE QUESTIONS

Can products containing pseudoephedrine or ephedrine only be sold in pharmacies? If so, where do they need to be kept?

It depends on the product’s classification at the federal level:

a) Natural Health Products (NHPs) containing pseudoephedrine and/or ephedrine (i.e., products assigned a NPN by Health Canada) are beyond the scope of the NAPRA National Drug Schedules (NDS) and therefore are not subject to the related NAPRA NDS conditions of sale. However, pseudoephedrine and ephedrine are still defined as ‘drugs’ by Ontario regulations, which limits their sale to accredited pharmacies in Ontario. In addition, Health Canada’s Ministerial Order sets out retail sale prohibitions for these NHPs across the country.

Designated Managers must ensure that these products are only available for sale while the pharmacy is in operation (i.e., when a pharmacist is physically present in the pharmacy, providing direct supervision to personnel).

Health Canada’s Order outlines the following conditions-of-sale restrictions:

Non-combination (“single entity”) NHPs containing only pseudoephedrine and/or ephedrine as medicinal ingredient(s) cannot be accessible to the public for self-selection (e.g., must be kept behind the counter).
Combination NHPs containing pseudoephedrine and/or ephedrine plus one or more other NHP ingredients (substances in Schedule 1 of the Natural Health Product Regulations) can be accessible to the public in the self-selection area of the pharmacy.

These restrictions also apply to remote dispensing locations (RDLs) and online sales. See related FAQ on “Who can sell products containing pseudoephedrine or ephedrine in the pharmacy.”

b) Health Canada’s Order does not apply to non-prescription drugs (NPDs) containing pseudoephedrine and/or ephedrine and other drugs (i.e., products assigned a DIN by Health Canada). Ontario regulations require pharmacies to follow the conditions of sale for a drug according to the NAPRA National Drug Schedules (NDS).

Therefore, if the NPD contains:

Schedule II or III drug(s): The ingredient with the most stringent NAPRA schedule determines its conditions for sale (e.g., if the NPD contains Schedule II and III drugs, then Schedule II applies).
Unscheduled (“Schedule U”) drug(s): They are not subject to the regulations and may be sold by any retail outlet.

In any case, the Designated Manager can choose to keep any NHP or NPD containing pseudoephedrine and/or ephedrine behind the counter if there are concerns about misuse or diversion.

Who can sell products containing pseudoephedrine or ephedrine in the pharmacy? Is professional intervention required by the pharmacist at the point of sale?

It depends on the product’s classification at the federal level:

a) Natural Health Products (NHPs) containing pseudoephedrine and/or ephedrine (i.e., products assigned a NPN by Health Canada) are not included in the NAPRA National Drug Schedules (NDS) and therefore are not subject to the related NAPRA NDS conditions of sale. However, they are still defined as ‘drugs’ by Ontario regulations and Health Canada’s Ministerial Order sets out retail sale prohibitions for these products.

Health Canada’s Order outlines the following conditions-of-sale restrictions:

Non-combination (“single entity”) NHPs containing only pseudoephedrine and/or ephedrine as medicinal ingredient(s) can only be sold by a pharmacist or a person working under the supervision of a pharmacist.
Combination NHPs containing pseudoephedrine and/or ephedrine plus one or more other NHP ingredients (substances in Schedule 1 of the Natural Health Product Regulations) can be sold only if a pharmacist is available to assist consumer prior to purchase if requested.

These restrictions also apply to remote dispensing locations (RDLs) and online sales. See related FAQ on “Can products containing pseudoephedrine or ephedrine only be sold in pharmacies?”

b) Health Canada’s Order does not apply to non-prescription drugs (NPDs) containing pseudoephedrine and/or ephedrine and other drugs (i.e., products assigned a DIN by Health Canada).

As Ontario regulations require pharmacies to follow the conditions of sale for a drug according to the NAPRA National Drug Schedules (NDS), if the NPD contains:

Schedule II or III drugs
- The ingredient with the most stringent NAPRA NDS conditions for sale determines whether pharmacist intervention is required; and
- The Supplemental Standards of Practice for Schedule II and III Drugs apply.
Unscheduled drug(s)
- They are not subject to the regulations and may be sold by any retail outlet.

In any case, the Designated Manager can choose to implement procedures for a pharmacist to intervene in the sale of any NHP or NPD containing pseudoephedrine and/or ephedrine, if there are concerns about misuse or diversion.

What is the maximum quantity of products containing pseudoephedrine or ephedrine that can be sold at a time?

The federal Precursor Control Regulations sets a maximum amount of pseudoephedrine and/or ephedrine that may be sold per package*, but not a limit on the total amount or quantity of pseudoephedrine and/or ephedrine that may be sold per transaction. Nevertheless, registrants have a professional and ethical obligation to prioritize the safety and best interests of the patient and the public.

If diverted to the illicit market, pseudoephedrine or ephedrine can be used to illegally produce D-methamphetamine (“meth”, “crystal meth”), which poses a significant risk to public health and safety. Given these risks, registrants must remain vigilant and exercise professional judgment when determining the quantity to sell, considering the patient and circumstances, to prevent potential substance misuse. For example, a registrant may restrict or limit the quantity sold to an individual if the request appears inappropriate based on their assessment.

*Based on maximum amount of pseudoephedrine and/or ephedrine base per package (e.g., maximum for pseudoephedrine base is 3 grams = 3.659 grams pseudoephedrine HCL). For conversion factors, refer to: https://www.deadiversion.usdoj.gov/quotas/conv_factor/index.html.

I’m a pharmacist practicing in Ontario and wondering where I can find resources on the MedsCheck program?

Published in the Pharmacy Connection Summer 2018 edition.

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 and Long Term Care (MOHLTC). Information related to billing, such as submitting a claim for reimbursement and the required paperwork, can be found in the materials available on the MOHLTC 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 Medscheck.Moh@ontario.ca.

I have a question regarding the Smoking Cessation Program. Are pharmacists required to take a smoking cessation training program or special course? If so, which specific programs will qualify?

Published in the Pharmacy Connection Summer 2018 edition.

As explained in the Guideline Initiating, Adapting and Renewing Prescriptions, 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 MOHLTC.

What training is needed before I can dispense Mifegymiso® (mifepristone 200mcg/misoprostol 200mg)?

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 (CPhA) has published a checklist for pharmacists and the Society of Obstetricians and Gynecologists of Canada (SOGC) offers a training program.
https://sogc.org/

When transferring a logged prescription to another pharmacy, is it a legal requirement to provide the receiving pharmacy a copy of the original prescription along with all of the information included in the fax?

Published in the Pharmacy Connection Fall 2018 edition.

Providing a copy of the original with the transfer would be considered a best practice in the interest of patient safety. Unlike a refill, the logged prescription has never been dispensed and has not gone through the same complete checking process. This is the same reason registrants within their own practice site should be retrieving or viewing the original hardcopy before a logged prescription is dispensed.

The Code of Ethics also expects that when a patient moves from one healthcare provider to another, the relevant information is provided to the receiving healthcare provider, to ensure safe and effective transition of care

Can someone who completed their PharmD use this credential and title while practicing within the province? Are there any restrictions on how it is used?

Published in the Pharmacy Connection Fall 2018 edition.

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.

What is the difference between the NAPRA Schedules and Schedules of O. Reg. 256/24? How do I know when a drug can be administered and whether a prescription is required?

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: Ask a Practice Consultant: Navigating Drug Scheduling in Ontario
NAPRA NDS Update on Clarification of Vaccine Scheduling in the National Drug Schedules

PHARMACY TECHNICIANS

To what degree are pharmacy technicians allowed to work independently in the dispensary? For example, can they check and sign for blister packs independently, or does that still require a pharmacist to cosign the hard copies? Also, are they able to process, fill and sign for a repeat prescription independently or does it have to be cosigned by a pharmacist as well? My assumption is that they would be able to do these things since the original therapeutic check was already done by a pharmacist who checked and signed the original prescription and they would be just refilling it?

Published in the Pharmacy Connection Winter 2018 edition.

The legislation (O. Reg 256/24) states “Every certificate of registration as a pharmacy technician is subject to the following terms, conditions and limitations: 1. The member shall only engage in the practice of pharmacy (…) when practising in a pharmacy to which the Drug and Pharmacies Regulation Act applies, other than a remote dispensing location, while under the direct supervision of a member holding a certificate of registration as a pharmacist…”

A technician can check any/all prescriptions for technical accuracy and completeness. Every prescription – new and refill, regardless of how they are packaged – must have both the technical and therapeutic check completed prior to release to the patient. Please refer to the page “Understanding What a Technician Can Do” for more details; note that the term “co-signing” is not used, as each registrant is performing an independent “check” for different purposes.

A suitable method for documenting both “checks” for a given prescription may be signatures (or some other identifying mechanism) from both registrants on every hardcopy. However, other methods may be suitable to document the respective actions and associated responsibilities in the dispensing process. As software, workflow, personnel, etc. can vary from pharmacy to pharmacy, the information presented on our website is not meant to be entirely prescriptive for how a pharmacy achieves the desired end result, which is to ensure the patient receives a prescription that is both technically accurate and therapeutically appropriate.

Ultimately, registrants remain accountable for their respective roles in dispensing a prescription, and documentation on the patient record should reliably demonstrate that every prescription has been reviewed for both technical and therapeutic aspects before it is dispensed. It should be readily retrievable, auditable, and be unambiguous. When and how these functions occur, and what form they take (i.e. operational procedures) are at the discretion of the pharmacist and technician in consultation with the Designated Manager.

Additional Resource

Article: Fall 2016 – Pharmacy Technicians – Professional Responsibilities and Standards of Practice

Can pharmacy technicians witness MMT doses?

Adapted from FAQ published in the Pharmacy Connection Winter 2018 edition.

The College’s Opioid Policy expects pharmacists providing Opioid Agonist Treatment (OAT) to practice in accordance with CAMH’s Opioid Agonist Maintenance Treatment: A Pharmacist’s Guide to Methadone and Buprenorphine for Opioid Use Disorder and the Standards of Practice.

When dispensing methadone (MMT), the pharmacist is responsible for the therapeutic check of the prescription, assessing the patient, and witnessing the administration and ingestion of observed doses. These functions cannot be delegated to a pharmacy technician by the pharmacist.

Part A pharmacy technicians have the independent authority to check the accuracy of the technical components of methadone prescriptions. Pharmacy technicians may also be responsible for other tasks in the workflow that fall within their competencies such as checking the prescription for technical accuracy, dose preparation, assisting with documentation and inventory management, etc.

Does a pharmacy technician have the scope of practice to perform a Best Possible Medication History (BPMH) when a patient is admitted to – or discharged from – hospital?

Published in the Pharmacy Connection Fall 2019 edition.

The Pharmacy Act and Ontario Regulation 256/24 – General define Scope of Practice and Authorized Acts for all pharmacy professionals. The steps involved in conducting a BPMH, such as gathering patient records from various sources and identifying discrepancies, are not necessarily governed by legislation. However, the regulation does set out Terms, Conditions and Limitations on a pharmacy technician’s certificate of registration, and pharmacy technicians cannot provide information or education relating to drug use which requires therapeutic knowledge, clinical analysis or assessment (s18.4).

Pharmacy technicians responsible for performing a BPMH must have the appropriate knowledge, skills and training to meet the Standards of Practice for Pharmacy Technicians outlined in #9-#12. When collaborating to provide patient care, technicians are expected to document their decisions and actions in the patient’s health record, including the relevant health and drug information they’ve obtained and their interpretation of this information.

The Pharmacy Manager/Administrator should establish policies and procedures for conducting medication reconciliations, outlining the respective roles for pharmacy technicians and pharmacists. OCP resources to consult include the Hospital Assessment Criteria, Standards of Operation, and the Pharmacy Technician Practice Assessment Criteria. External resources are also available from organizations such as the Canadian Society of Hospital Pharmacists (CSHP), ISMP Canada, the Canadian Patient Safety Institute (CPSI), etc. Collaborating with peers at other hospitals to share operational advice and best practices is also encouraged.

SCOPE OF PRACTICE

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.

Published in the Pharmacy Connection Spring 2018 edition.

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 – 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. 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.

Can pharmacists provide professional services to veterinary patients, such as prescribing to renew or adapt a prescription, or for a minor ailment?

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.

Can a pharmacy professional administer a substance by injection if it is not listed in Schedule 1 of O. Reg. 256/24 in a potentially life-threatening situation (e.g., epinephrine, glucagon, naloxone, etc.) without a medical directive?

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.

Can a pharmacy professional administer a substance that is inhaled through the nose (e.g., flu vaccine, naloxone, etc.) if it is not listed in Schedule 2 of O. Reg. 256/24, without a medical directive?

Yes. Appendix A of the Administering a Substance by Inhalation Guideline 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 intranasal administration, the drug is intended to be delivered to the mucous membranes lining the nasal passages. With inhalation, the drug is intended to be delivered to the epithelium lining the lower respiratory tract.

Therefore, 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). This should still be done in accordance with the Administering a Substance by Inhalation Guideline, the Code of Ethics and Standards of Practice.

Pharmacy students are not registered with the College. Can they accept verbal prescriptions or authorize prescription transfers?

Yes. Federal regulations authorize pharmacists to accept verbal prescriptions and to transfer prescriptions. These regulations define pharmacist as a person who is registered or otherwise entitled under the laws of a province to practise pharmacy and is practising in that province.

In Ontario, students enrolled in a pharmacy education program can practice pharmacy under the supervision of a Part A pharmacist without being registered because of an exception in the Regulated Health Professions Act. Since they meet the definition of pharmacist for the purposes of the regulations, they can accept verbal prescriptions and transfer prescriptions.

Verbal prescriptions can be accepted for drugs on the Prescription Drug List (“prescription drugs”) and certain controlled substances — specifically controlled drugs, verbal prescription narcotics, and benzodiazepines & other targeted substances.

For transfers, prescriptions for prescription drugs can be transferred by a pharmacy student to another pharmacy student or to any registrant of the College. However, prescriptions for benzodiazepines & other targeted substances must be transferred to another pharmacy student, intern or pharmacist. Importantly, any of the additional activities permitted by the Health Canada subsection 56(1) class exemption under the Controlled Drugs and Substances Act cannot be performed by pharmacy students or interns, because the exemption defines pharmacist as a person “who is entitled under the laws of a province or territory of Canada to practise as a pharmacist.”

For a summary of the legislation and exemption, refer to the Legal Scope of Practice & Authorized Acts chart.

Pharmacy technician students are not registered with the College. Can they accept verbal prescriptions or authorize prescription transfers?

Yes. Federal regulations authorize pharmacy technicians to accept verbal prescriptions and to transfer prescriptions for drugs on the Prescription Drug List. These regulations define pharmacy technician as a person who is registered or otherwise entitled under the laws of a province to practise pharmacy and is practising in that province.

In Ontario, students enrolled in a pharmacy technician education program can practice pharmacy under the supervision of a Part A pharmacist without being registered because of an exception in the Regulated Health Professions Act. Since they meet the definition of pharmacy technician for the purposes of the regulations, they can accept verbal prescriptions and transfer prescriptions.

Pharmacy technicians, pharmacy technician students, and intern technicians cannot perform either of these activities for prescriptions for controlled substances (narcotics, controlled drugs, and benzodiazepines & other targeted substances).

For a summary of the legislation, refer to the Legal Scope of Practice & Authorized Acts chart.

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