⚖️ Canadian Pharmacy Law, Ethics and Practice Management

1. Which level of government regulates a drug as a product, and which regulates the practice of pharmacy?

1. Ottawa regulates the product, provinces the profession.
2. The provinces regulate both the product and the profession.
3. The federal government regulates both.
4. Municipalities regulate the profession.

Parliament legislates on drugs as articles of commerce through the Food and Drugs Act and the Controlled Drugs and Substances Act, while each province regulates licensure, scope of practice and pharmacy operation through its college. This is why scope differs across the country. Source: Food and Drugs Act and provincial pharmacy legislation.

2. Which statute governs the safety, effectiveness and labelling of drugs sold in Canada?

1. The Food and Drugs Act and its regulations.
2. The Controlled Drugs and Substances Act alone.
3. The provincial pharmacy act.
4. The Canada Health Act.

The Food and Drugs Act and the Food and Drug Regulations govern approval, manufacture, labelling and advertising; the Controlled Drugs and Substances Act adds a separate layer for substances with abuse potential. The Canada Health Act concerns insured health services, not drug approval. Source: Food and Drugs Act.

3. What characterises a Schedule I drug in the National Drug Schedules?

1. It may be sold from any retail outlet.
2. It requires a prescription.
3. It may be selected from an open shelf.
4. It is sold after a pharmacist intervention.

Schedule I products are dispensed on a prescription within a regulated professional relationship; Schedules II and III and unscheduled products describe progressively lower levels of required intervention. Source: NAPRA National Drug Schedules.

4. What are the conditions of sale for a Schedule II product?

1. No prescription, but a pharmacist must intervene.
2. It requires a written prescription from a prescriber.
3. It may be sold in a grocery store without restriction.
4. It may be self-selected from an open shelf.

Schedule II products such as low-dose insulin, some emergency contraceptives and certain analgesics sit behind the counter and require a professional assessment before sale, without a prescription. Source: NAPRA National Drug Schedules.

5. What distinguishes a Schedule III product from a Schedule II product?

1. Schedule III must be stored in a locked cabinet.
2. Schedule III requires a written prescription.
3. Schedule III may be sold in any retail outlet.
4. Schedule III is self-selected under supervision.

Schedule III products are available for patient self-selection within a defined area where the pharmacist is available for advice, whereas Schedule II products are not accessible to the public at all. Source: NAPRA National Drug Schedules.

6. Where may an unscheduled product be sold?

1. Only in a pharmacy after assessment.
2. In any retail outlet.
3. Only from behind the pharmacy counter.
4. Only on presentation of a prescription.

Unscheduled products carry adequate labelling for safe self-selection and may be sold anywhere; being unscheduled does not mean the pharmacist has nothing to contribute, because interactions and duplication still apply. Source: NAPRA National Drug Schedules.

7. Who maintains the National Drug Schedules, and who gives them legal force?

1. The manufacturer assigns the schedule when the product is approved.
2. Health Canada maintains and enforces them directly in every province.
3. Each pharmacy sets its own schedule for the products it sells.
4. NAPRA maintains them and each province adopts them into its own legislation.

The national schedules are a harmonising instrument developed by the regulatory authorities collectively, but they take effect through provincial adoption, which is why a product can occasionally be scheduled differently in one province. Source: NAPRA National Drug Schedules.

8. Which statute and regulations govern narcotics in Canada?

1. The Personal Information Protection and Electronic Documents Act and its schedules
2. The Food and Drugs Act and the Natural Health Products Regulations, which cover all analgesics
3. The Canada Health Act and the provincial formulary regulations that list insured products
4. The Controlled Drugs and Substances Act and the Narcotic Control Regulations.

Narcotics fall under the Narcotic Control Regulations made under the Controlled Drugs and Substances Act, with controlled drugs under Part G of the Food and Drug Regulations and benzodiazepines under the Benzodiazepines and Other Targeted Substances Regulations. Source: Controlled Drugs and Substances Act.

9. What form must a prescription for a straight narcotic take?

1. It may be transferred from another pharmacy provided the original prescription is faxed as well
2. It may be given verbally by telephone and refilled twice within one year of the original date
3. It may be given verbally provided the pharmacist records the prescriber's registration number
4. It must be written and signed by the prescriber.

A straight narcotic requires a written, signed prescription, carries no refills and cannot be transferred to another pharmacy; part-fills are permitted when the prescriber authorises them and each is documented. Source: Narcotic Control Regulations.

10. What is a verbal prescription narcotic?

1. A narcotic for which the prescriber has given a verbal authorisation for two further refills
2. Any narcotic prescribed by telephone in an emergency situation by any authorised prescriber
3. A narcotic supplied in a quantity small enough not to require a written prescription document
4. A preparation containing one narcotic and at least two other non-narcotic medicinal ingredients.

A combination such as codeine with acetaminophen and caffeine falls into this category and may be prescribed verbally, but it still carries no refills; the number of non-narcotic ingredients is what defines the category. Source: Narcotic Control Regulations.

11. May a narcotic prescription be refilled?

1. Twice.
2. Yes.
3. Once.
4. No.

The regulations do not permit refills on a narcotic prescription; continued therapy requires a new prescription, although a prescriber may authorise part-fills of a single prescription with the intervals specified. Source: Narcotic Control Regulations.

12. What is a part-fill of a narcotic prescription?

1. Supplying the prescription at two different pharmacies on the same calendar day
2. Supplying half the quantity and destroying the remainder of the prescribed amount
3. Supplying the whole quantity but billing the patient for only part of the total
4. Supplying the prescription in instalments as the prescriber has directed, with each portion documented.

Part-fills allow the total authorised quantity to be released over time, which supports safer supply and reduces diversion; the prescriber's instruction, the portions supplied and the balance remaining are all recorded. Source: Narcotic Control Regulations.

13. May a narcotic prescription be transferred to another pharmacy?

1. Yes.
2. No.
3. Once.
4. Maybe.

Transfer of a narcotic or controlled drug prescription between pharmacies is not permitted; the patient obtains a new prescription. Targeted substances such as benzodiazepines are treated less restrictively. Source: Narcotic Control Regulations.

14. How are benzodiazepines regulated compared with narcotics?

1. They are not federally regulated at all.
2. Identically, because both fall under the Narcotic Control Regulations.
3. More restrictively, because of their dependence potential.
4. Less restrictively: verbal orders and refills are allowed.

The Benzodiazepines and Other Targeted Substances Regulations permit verbal prescriptions and refills within the period set out, while still requiring secure storage, record keeping and reporting of loss or theft. Source: Benzodiazepines and Other Targeted Substances Regulations.

15. To whom is a loss or theft of a narcotic reported?

1. The wholesaler that supplied the stock, within thirty days of the discovery
2. The provincial college only, at the next scheduled inspection of the pharmacy
3. Health Canada's Office of Controlled Substances, within ten days of discovery.
4. No one, provided the shortage is documented in the pharmacy's own records

Loss or theft of a narcotic, controlled drug or targeted substance is reported to the federal Office of Controlled Substances within ten days, and forged prescriptions are reported the same way; local police and the provincial college may also require notification. Source: Narcotic Control Regulations.

16. What is the pharmacist's obligation on discovering a forged narcotic prescription?

1. Destroy the document immediately so that it cannot be used at another pharmacy
2. Dispense a small quantity and report the matter afterwards to the prescriber
3. Return the document to the person presenting it and refuse further discussion
4. Do not dispense, keep the document, and report it as the regulations require.

The prescription is not filled, the document is retained as evidence, the federal report is made within the required period, and the prescriber and, where appropriate, other local pharmacies are alerted. Personal safety governs how the encounter is handled. Source: Narcotic Control Regulations and provincial college guidance.

17. What record keeping applies to narcotics in a community pharmacy?

1. Receipts, sales and destructions are recorded and reconciled.
2. No specific records are required beyond the dispensing record.
3. Only the quantity purchased must be recorded each year.
4. Records are required only for injectable narcotics.

A perpetual inventory of receipts and dispensing, periodic reconciliation, secure storage and documented destruction with a witness are the standing obligations, and the records must be available for inspection. Source: Narcotic Control Regulations.

18. How is expired or unusable narcotic stock destroyed in a community pharmacy?

1. By returning it to the patient who did not use it.
2. A documented, witnessed destruction procedure.
3. By placing it in the ordinary pharmacy waste.
4. By flushing it into the municipal sewer system.

Destruction is documented, witnessed and recorded, and the requirements differ between stock the pharmacy owns and post-consumer returns brought in by patients, which are handled through the take-back programme. Source: Narcotic Control Regulations and provincial college guidance.

19. Which elements must appear on a valid prescription?

1. Patient identification, drug, strength, quantity, directions, date, prescriber identification and signature where required.
2. Only the drug name and the quantity to be supplied.
3. Only the prescriber's name and professional number.
4. Only the patient's name and the date of the order.

A prescription that is missing any of these is clarified before dispensing rather than completed by assumption, and additional elements are required for controlled substances in several provinces. Source: provincial pharmacy legislation and college standards.

20. A prescription states a drug and a quantity but no directions. What is the correct action?

1. Contact the prescriber for clarification before dispensing.
2. Dispense with the label reading as directed.
3. Use the directions from the patient's previous prescription.
4. Ask the patient what the prescriber intended and label accordingly.

A label reading as directed leaves no record of the intended regimen for the patient or for any other professional, and assuming the previous directions may perpetuate an error; the clarification and the person who gave it are documented. Source: provincial college standards of practice.

21. What must appear on the label of a dispensed prescription?

1. Only the drug name and the directions for use.
2. The drug, the directions, the patient and the date.
3. Only the pharmacy name and the prescription number.
4. Only the patient's name and the expiry date.

The label allows the patient and any other professional to identify what was supplied, by whom and how it is to be taken, and provincial requirements add elements such as the identity of the pharmacist and any auxiliary warnings. Source: provincial pharmacy legislation.

22. For how long is a prescription generally valid?

1. For the period stated in provincial legislation or by the prescriber, commonly up to one year.
2. Indefinitely, until the full quantity and every refill have been supplied to the patient
3. For thirty days from the date of writing, in every province and for every class of drug
4. Until the manufacturer's expiry date printed on the stock container that is used

Provincial rules set an outer limit, and a prescriber may specify a shorter one; controlled substances often carry tighter limits, and a prescription that is old is reviewed for continuing appropriateness rather than filled automatically. Source: provincial pharmacy legislation.

23. A patient presents a prescription written in another province. What applies?

1. It may be filled only if the patient has moved permanently.
2. It can never be filled outside the province where it was written.
3. Generally yes, subject to the rules of the receiving province.
4. It must first be rewritten by a local prescriber in every case.

Out-of-province prescriptions are commonly accepted with verification of the prescriber's authorisation, but controlled substances and provincially restricted programmes carry additional requirements, and the receiving province's law governs. Source: provincial pharmacy legislation.

24. A patient has run out of a chronic medicine and cannot reach the prescriber. What may the pharmacist do?

1. Supply the medicine and make no record of having done so.
2. Supply a full year's quantity without any notification.
3. Refuse and tell the patient to attend an emergency department.
4. Assess and provide a continuity of care supply if allowed.

Most provinces authorise an emergency or continuity supply of a defined duration after an assessment, with documentation and notification to the prescriber; the authority and the quantity vary by province and generally exclude controlled substances. Source: provincial pharmacy legislation and college standards.

25. May a prescription be transferred between pharmacies?

1. Only when the two pharmacies are owned by the same corporation and share a database
2. Yes for every drug including narcotics, provided the transfer is documented in writing
3. No, under no circumstances may any prescription move between two pharmacies in Canada
4. Yes for most drugs, following the provincial procedure, but not for narcotics or controlled drugs.

Transfers require pharmacist-to-pharmacist communication and documentation on both sides, and the federal regulations prohibit them for narcotics and controlled drugs. Source: Narcotic Control Regulations and provincial college standards.

26. What does interchangeability mean on a provincial formulary?

1. The products may be mixed together in one container.
2. The products contain identical excipients.
3. The products are made by the same manufacturer.
4. The province has designated them as substitutable.

Interchangeability is a provincial designation resting on Health Canada's bioequivalence determination, and it governs both substitution authority and the reimbursed price; a prescriber may block substitution where provincial rules allow. Source: provincial drug benefit legislation.

27. A prescription is marked no substitution. What does the pharmacist do?

1. Dispense the brand written, and discuss the reason with the prescriber if a generic would be preferable.
2. Substitute anyway, because interchangeability is a legal right of the pharmacist
3. Refuse to fill the prescription until the notation has been removed by the prescriber
4. Dispense the generic and inform the prescriber afterwards in writing within thirty days

The notation is honoured, and provincial reimbursement rules determine whether the patient pays the difference; if there is a clinical reason to prefer another product, that is a conversation with the prescriber rather than a unilateral change. Source: provincial drug benefit legislation and college standards.

28. What does a Drug Identification Number indicate?

1. That Health Canada has assessed the product and authorised it for sale.
2. That the product is covered by every provincial drug plan in Canada without exception
3. That the product has been proven superior to every alternative on the Canadian market
4. That the product may be sold without any professional involvement in any retail outlet

The DIN identifies the manufacturer, product name, ingredients, strength and dosage form and confirms authorisation for sale; it says nothing about reimbursement, comparative efficacy or the schedule that applies. Source: Food and Drug Regulations.

29. What does a Natural Product Number on a natural health product indicate?

1. That Health Canada has reviewed it for safety, quality and the claims made.
2. That the product has been shown to be as effective as a prescription medicine
3. That the product carries no risk of interaction with any prescription medicine
4. That the product is manufactured in Canada rather than imported from elsewhere

An NPN or a homeopathic number reflects a regulatory assessment appropriate to the class of product, not proof of clinical efficacy; several natural health products interact meaningfully with prescription therapy. Source: Natural Health Products Regulations.

30. What is the Special Access Programme used for?

1. Obtaining a marketed drug at a reduced price for a patient without coverage
2. Requesting a drug that is not marketed in Canada for a patient with a serious condition when other options have failed.
3. Approving a new indication for a product already marketed in Canada
4. Allowing a pharmacist to compound a product that already exists commercially

The practitioner applies to Health Canada with the clinical rationale, and the programme provides access on a case-by-case basis; it is not a route to cheaper supply or to a shortcut around the approval process. Source: Food and Drug Regulations, Special Access Programme.

31. What may be advertised to the public about a prescription drug in Canada?

1. The name, price and quantity.
2. The full indications, with the source cited.
3. Any claim, if the product holds a DIN.
4. The benefits, with adverse effects listed.

Direct-to-consumer advertising of a prescription drug is limited to name, price and quantity, and separate restrictions apply to claims about the diseases listed in the Act's schedule. Advertising to health professionals is governed differently. Source: Food and Drugs Act and Food and Drug Regulations.

32. What characterises a Type I recall?

1. A cosmetic defect in the packaging with no health consequence at all for the patient
2. A reasonable probability that use of the product will cause serious harm or death.
3. A product that is close to its expiry date and is therefore being withdrawn from sale
4. A product whose price has changed and which is therefore being repackaged by the maker

Type I is the most serious class and normally requires action to patient level, while Type II involves temporary or reversible harm and Type III is unlikely to cause harm; the pharmacy quarantines affected stock, documents the action and contacts patients where indicated. Source: Health Canada recall policy.

33. A Type I recall names a lot number that the pharmacy has dispensed. What must happen?

1. Remove the stock quietly and say nothing to patients.
2. Wait for patients to contact the pharmacy with a complaint.
3. Quarantine stock, contact affected patients, document.
4. Continue dispensing the remaining stock until it is exhausted.

Recall to patient level requires the dispensing records to be searched, patients contacted with clear instructions and an alternative arranged; the pharmacy's actions and the manufacturer's instructions are documented. Source: Health Canada recall policy and provincial college standards.

34. How does a community pharmacist report a suspected serious adverse drug reaction?

1. Through the Canada Vigilance programme, voluntarily.
2. Only through the manufacturer's own customer service department by telephone
3. Only to the provincial college, at the time of the pharmacy's next routine inspection
4. Reporting is not permitted by pharmacists and must be done by the prescriber alone

Reporting through Canada Vigilance, part of MedEffect, is voluntary for community practitioners and patients, while hospitals have mandatory reporting obligations for serious reactions and medical device incidents under legislation. Source: Health Canada Canada Vigilance programme.

35. Which institutions have a mandatory obligation to report serious adverse drug reactions?

1. Pharmacies.
2. Hospitals.
3. Manufacturers only.
4. Private prescribers.

Amendments to the Food and Drugs Act obliged hospitals to report serious adverse drug reactions and medical device incidents to Health Canada within the prescribed period; community reporting remains voluntary but is strongly encouraged. Source: Food and Drugs Act, Protecting Canadians from Unsafe Drugs Act.