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A comprehensive overview of canadian pharmacy jurisprudence, focusing on regulations governing narcotic and controlled drugs. It outlines prescription requirements, record-keeping procedures, and refill policies for various drug categories, including narcotics, controlled drugs, and verbal prescription narcotics. A valuable resource for pharmacy professionals and students seeking to understand the legal framework surrounding drug dispensing in canada.
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Narcotic drugs ✔✔All single-entity narcotics. All narcotics for parenteral use. All narcotic
compounds containing less than two other non-narcotic ingredients in a therapeutic dose. All products containing any substance listed in the schedule to the Narcotic Control Regulations.
Narcotic Drug Examples ✔✔Codeine, Codeine Syrup, Dilaudid, Fentanyl, Hycodan, Kadian,
Ketamine, Methadose, Morphine, Percocet, Subuxone, Tussionex, Tylenol No. 4, Tylenol with codeine elixir
Narcotic Drugs Prescription req ✔✔Written or faxed prescription by a physician, dentist,
vetrinarian, nurse practitioner, midwife or podiatrist
Narcotic Drug Prescriptions faxed ✔✔Schedule 1A drugs cannot be faxed (exception: licensed
facilities). Schedule 1A drugs an not be prescribed by podiatrists
Narcotic Drug Refills ✔✔No refils allowed. All re-orders must be new Rx. Written "part-fill"
instruction can be included, specifying the total prescription quantity plus the interval between each "part-fill." Transfer of "part-fills" and undispensed prescriptions are not permitted.
Narcotic Drug Sales Record ✔✔All prescription sales (except those for dextropropoxyphene)
must be recorded in a register or a computer-printed report. The register or computer-printed report must be current and kept for at least three years.
Files and Records - Recording the Rx ✔✔Narcotic and controlled drug purchases must be
recorded in a book or register and must be readily available.
Files and Records - Filing the Rx ✔✔Prescriptions for narcotics, controlled drugs and
preparations of either may be filed together, but must be separated from all other prescriptions.
Files and Records - Filling Rx in sequence ✔✔All prescriptions, whether in writing from the practitioner or received verbally and recorded by a pharmacist, must be filed in sequence according to date and prescription number or transaction number.
Files and Records - How long to store ✔✔All prescriptions must be kept for at least three years
after their most recent activity, including refill transactions.
control drug prescriptions, the part-fill history does not have to be filed with the original prescription provided that the software program allows tracking between the part-fills and the original prescription. A "paper trail" copy of the part-fill prescription must be created and filed on the date of dispensing the part-fill.
Verbal Prescription Narcotic Drug ✔✔Examples: Calmylin ACE, Coactifed, Cotridin, Dimetapp
C, 282 and 292, Fiorinal C ½, Fiorinal C ¼, ratioLenoltec-#2 and #3, Robitussin AC, Tylenol No.2 and No.
Verbal Prescription Narcotic Drug Description ✔✔A combination for other than parenteral use
containing only one narcotic drug plus two (or more) non-narcotic drugs in a therapeutic dose, except products containing diacetylmorphine (heroin) hydrocodone, methadone, oxycodone or pentazocine.
Verbal Prescription Narcotic Drug Prescribers ✔✔Written, verbal or faxed prescription by a
physician, dentist, veterinarian, nurse practitioner or podiatrist. Midwives may prescribe verbal prescription narcotic drugs.
Verbal Prescription Narcotic Drug Refills ✔✔No refills allowed. All "reorders" (written or
verbal) must be new prescriptions. Written or verbal "part-fill" instruction can be included, as noted above. Transfer of "part-fills" and undispensed prescriptions are not permitted.
Verbal Prescription Narcotic Drug Sales Record ✔✔Prescription sales do not need to be
recorded in a register or computer-printed report, except when an emergency supply is provided to another pharmacist and returns to licensed dealers.
Verbal Prescription Narcotic Drug Prescriptions must include ✔✔All prescriptions must include:
Patient's name Practitioner's name and signature (for written prescriptions) Name, strength, and quantity of drug(s) or ingredients Complete directions for use, including the frequency, interval or maximum daily dose Number of refills and intervals between refills/part-fills (when permitted) Date prescription written
Verbal Prescription Narcotic Drug Prescriptions must also include ✔✔The prescription record of
verbal prescriptions must include the signature or initial of the pharmacist who receives the verbal prescription authorization either directly from a practitioner or from a practitioner's recorded voice message.
Controlled Drug Part 1* examples ✔✔Stimulants. Examples: Adderall XR, Biphentin, Concerta,
Dexedrine, Ritalin, Vyvanse
Fiorinal ✔✔Figure out which one is in which category
Fioricet ✔✔Figure out which one is in which category
Controlled Drug Preparations Part 2 Description ✔✔Combination containing only one controlled
drug listed immediately above plus one (or more) active noncontrolled non-narcotic drug(s).
Controlled Drug Part 3 Examples ✔✔Examples: Andriol, Androderm, Androgel, Delatestryl
Injection, Depotestosterone, Testim.
Controlled Drug Part 3 Description ✔✔Drugs listed in Part III of the schedule to Part G of the
Food and Drug Regulations (e.g. anabolic steroids, zeranol)
Controlled Drug Part 1 Refills ✔✔No refills allowed if original prescription is verbal; however,
part-fills are allowed. If written, the original prescription may be refilled if the practitioner has indicated in writing the number of times and interval between refills. "Refill PRN" is not an acceptable authority for refilling a prescription. Transfer of undispensed prescriptions and authorized refills or "part-fills" are not permitted.
Controlled Drug Part 1 Preparations Refills ✔✔No refills allowed if original prescription is
verbal; however, part-fills are allowed. If written, the original prescription may be refilled if the practitioner has indicated in writing the number of times and interval between refills. "Refill PRN" is not an acceptable authority for refilling a prescription. Transfer of undispensed prescriptions and authorized refills or "part-fills" are not permitted.
Controlled Drug Part 2 Refills ✔✔Refills may be authorized on original written or verbal
prescription and must indicate the specific number of times and interval between refills. "Refill PRN" is not an acceptable authority for refilling a prescription. Requests for refills beyond those originally authorized necessitate the initiation of a new prescription. Transfer of undispensed prescriptions and authorized refills are not permitted.
Controlled Drug Part 2 Preparations Refills ✔✔Refills may be authorized on original written or
verbal prescription and must indicate the specific number of times and interval between refills. "Refill PRN" is not an acceptable authority for refilling a prescription. Requests for refills beyond those originally authorized necessitate the initiation of a new prescription. Transfer of undispensed prescriptions and authorized refills are not permitted.
Controlled Drug Part 3 Refills ✔✔Refills may be authorized on original written or verbal
prescription and must indicate the specific number of times and interval between refills. "Refill PRN" is not an acceptable authority for refilling a prescription. Requests for refills beyond those
Controlled Drug Part 3 Sales Record ✔✔Prescription sales do not need to be recorded in a
register or computer-printed report, except when an emergency supply is provided to another pharmacist and returns to licensed dealers.
Targeted Drug Substances (Part 1) Description ✔✔A product or compound that contains any substance listed in Schedule 1 of the Benzodiazepines and Other Targeted Substances Regulations (e.g. all benzodiazepines and their salts and derivatives (but excluding the thienobenzodiazepines:, flunitrazepam, olanzapine), clotriazepam, ethchlorvynol, ethinamate, fencamfamin, fenproporex, mazindol, mefenorex, meprobamate, methyprylon, pipradol)
Targeted Drug Substances (Part 1) Prescription Requirements ✔✔Written, verbal or faxed prescription by a physician, dentist, veterinarian, nurse practitioner or podiatrist. Midwives may prescribe benzodiazepines. Requirements of a prescription as on page one.
Targeted Drug Substances (Part 1) Refills ✔✔Refills may be authorized on original written or
verbal prescription and must indicate the specific number of times and interval between refills. "Refill PRN" is not an acceptable authority for refilling a prescription. Requests for refills beyond those originally authorized necessitate the initiation of a new prescription. Transfer of undispensed prescriptions and authorized refills by a pharmacist is only permitted once in the lifetime of the prescription.
Targeted Drug Substances (Part 1) Sales Records ✔✔Prescription sales do not need to be
recorded in a register or computer-printed report, except when an emergency supply is provided to another pharmacist and returns to licensed dealers.
Targeted Drug Substances (Part 1) Files and Records ✔✔1. Narcotic and controlled drug purchases must be recorded in a book or register and must be readily available.
Targeted Drug Substances (Part 1) Files and Records cont. ✔✔7. Each dispensing of a new
prescription, a refill/part-fill, a renewal or a balance owing must show the address of the patient, identification number from the practitioner's regulatory college, prescription number, date dispensed, drug identification number or brand name of the product dispensed, quantity
maximum daily dose Number of refills and interval between refills if applicable Date prescription written The prescription record of verbal prescriptions must include the signature or initial of the registrant who receives the verbal prescription authorization either directly from a practitioner or from a practitioner's recorded voice message
Other Prescription Drugs (Prescription Drug List) Formerly known as Schedule F to the Food and Drug Regulations Refills ✔✔Refills may be authorized on original written or verbal
prescriptions and must indicate the specific number of times and interval between refills. "Refill PRN" is not an acceptable authority for refilling a prescription. Transfer of undispensed prescriptions and authorized refills is permitted. A registrant who transfers a prescription to another registrant must enter the date of the transfer, the registrant's identification, identification of the community pharmacy to which the prescription was transferred, and identification of the person to whom the prescription was transferred on the patient record.
Other Prescription Drugs (Prescription Drug List) Formerly known as Schedule F to the Food and Drug Regulations Sales Record ✔✔Prescription sales do not need to be recorded.
Other Prescription Drugs (Prescription Drug List) Formerly known as Schedule F to the Food and Drug Regulations Files and Records ✔✔4. All prescriptions must be kept for at least three
years after their most recent activity, including refill transactions.
Controlled Prescription Program (CPP) Drugs Description ✔✔All drugs listed as Schedule 1A in
the Drug Schedules Regulation to the Pharmacy Operations and Drug Scheduling Act.
Controlled Prescription Program (CPP) Drugs Prescription Requirements ✔✔Written
prescription on an approved two-part form. Fax transmission is not allowed in community pharmacies (exception: licensed facilities) More than one strength of medication can be included on one Controlled Prescription Program form, provided the orders are legible. The prescription expires after midnight of the fifth day following the date of issuance by the practitioner, unless the prescription is for methadone.
practitioner's initials and address, form of drug, and name or initials of the pharmacist who transcribed the verbal order.
Food and Drug Regulations, Prescription Drug List includes ✔✔All prescription drugs available
for sale in Canada except for narcotic, controlled, and targeted drugs. It is divided into two parts. Part 1 includes regular prescription drugs for human use which are neither narcotic, controlled or targeted drugs. Part 2 includes drugs for veterinary use.
If drug is not listed in Provincial drug schedule but is listed in Prescription Drug List does it
require a prescription ✔✔If a drug is not listed in the provincial drug schedule but is listed in the
Prescription Drug List, the drug still requires a prescription. Such a discrepancy may exist when
the drug is new to the market but the amendment to the provincial drug schedule has not been made.
Drugs that are not assigned prescription status by Health Canada (i.e. not listed in the Prescription Drug List) and are not listed in any schedule of the Controlled Drug Substances Act
(CDSA) and its Regulations ✔✔Provinces and territories can restrict the condition of sale of
these nonprescription drugs as long as they are not less stringent than the Federal legislation. Many provinces and territories adopted the National Drug Schedules from NAPRA, but BC has its own provincial drug schedules to follow. Therefore, a discrepancy in the drug schedules for a non-prescription product may be seen in BC when comparing the same product in another province.
Drugs that are not assigned prescription status by Health Canada (i.e. not listed in the
Prescription Drug List) and are not listed in the BC drug schedules ✔✔Means that they are
unscheduled drug products. E.g. chlorpheniramine. They can be placed outside the 25-foot perimeter of the pharmacy or be sold from non-pharmacy outlets
A drug listed in the Prescription Drug List under the Food and Drug Regulations that is a prescription may be included under a different name or therapeutic classification in the BC drug
schedules ✔✔For example: estrogen and progesterone are included under Sex Hormones;
To determine what drugs a practitioner can prescribe ✔✔refer to their provincial professional
regulation. For example, under the Midwives Regulations, midwives can prescribe Schedule I, IA or II of the Drug Schedules Regulation, whereas under the Podiatrist Regulation, they can prescribe Schedule I and II drugs only (i.e. not Schedule IA drugs). Therefore, federally, podiatrists can prescribe controlled drug substances but their provincial regulation needs to enable them to prescribe all controlled drug substances. Podiatrists are limited to prescribe Schedule I controlled drug substances but cannot prescribe Schedule IA drugs
Pursuant to the Food and Drug Regulations and the Narcotic Control Regulations, prescriptions and any records must be retained for a period of two years. Section 23(1) of the PODSA Bylaws states that prescriptions and patient records must be retained for three years from the date of the
last refill. ✔✔In this case, BC provincial legislation overrides the federal legislation as it is more
stringent. As a result, invoices recording the purchase and receipt of Schedule 1 drugs and drugs under the Controlled Drugs and Substances Act and any records documenting the transfer of such drugs for any reason other than as authorized by a practitioner's prescription must be retained for not less than three years.
The definition of Controlled Drugs Part 1, Part 2 and Part 3 is described in the Prescription Regulations Chart ✔✔Controlled Drug Part 1 = reportable control drugs Controlled Drug Part 2
= non-reportable control drugs Controlled Drug Part 3 = non-reportable anabolic steroids
Targeted drugs: Part 1: ✔✔Drugs which may be sold (benzodiazepines and others)
Targeted drugs: Part 2: ✔✔Drugs which may not be sold as they are illegal to possess
In BC a prescription with authorized ongoing refills is only valid for one year from the
prescribing date of the original prescription ✔✔The only exception is prescriptions for oral contraceptives, for which the time span for ongoing prescription authorization is a maximum of two years from the prescribing date (HPA Bylaws, Schedule F, Part 1, Community Pharmacy Standards of Practice, Section 10(5)).
Veterinary drugs sales ✔✔Cannot be sold without a prescription from a veterinarian unless they
are sold only in the manufacturers original container labeled "for veterinary use only" or "for agricultural use only." The pharmacist cannot repackage veterinary drugs to be sold without a prescription.
Controlled Prescription Drug faxed Rx ✔✔A registrant must not dispense a prescription
authorization received by facsimile transmission for a drug referred to on the Controlled Prescription Drug List.