PRESCRIPTIONS
A pharmacist or certified dispenser shall take reasonable steps to ensure a written, verbal or faxed prescription, where permitted, is authentic and the prescriber is licensed and practices in Canada and belongs to a class of persons who, if licensed in Nova Scotia, would be entitled by law to prescribe that drug or device in Nova Scotia. • There shall be no initial dispensing of a prescription and no prescription shall be refilled after a period of one year from the date prescribed. • Currently in Nova Scotia, only physicians, dentists, nurse practitioners and veterinarians are authorized to prescribe Narcotic and Controlled Drugs and Substances. Optometrists and midwives have limited prescribing authority to prescribe Prescription Drugs but only under the conditions set out in their respective provincial legislation.
No
PRESCRIPTION TRANSFERS (Refer to NSCP Transfer of Prescriptions policy)
Summary
Transfers are not permitted for Narcotic and Controlled Drugs. Upon request, a pharmacist or pharmacy technician shall transfer a prescription or the remaining refills of a prescription to another pharmacist or pharmacy technician licensed in a Canadian jurisdiction, provided the prescription does not include a Narcotic or Controlled drug. • A prescription for a Targeted Substance (e.g. benzodiazepines) may be transferred by a pharmacist; however, once it has been received at a second pharmacy, NO further transfer is permitted. The Benzodiazepines and Targeted Substances Regulations do not authorize pharmacy technicians to transfer such prescriptions. • When transferring a prescription from outside Nova Scotia, the prescriber must be licensed and practicing in Canada and belong to a class of persons who, if licensed in Nova Scotia, would be entitled by law to prescribe that drug or device in Nova Scotia. • The pharmacist or pharmacy technician who transfers a prescription shall enter the fact that the prescription was transferred on the patient’s record and include the date of transfer, the name of the receiving pharmacist or pharmacy technician and pharmacy, the identity of the transferring pharmacist or pharmacy technician and any other relevant information and cancel all remaining refills. • The pharmacist or pharmacy technician to whom a prescription has been transferred shall reduce the prescription to writing and record the name of the transferring pharmacist or pharmacy technician and pharmacy, the number of authorized refills remaining, the date of the last refill, the date of the original prescription and the prescription number. Note: The transfer must comply with the Food & Drug Act (Canada), the Controlled Drugs and Substances Act (Canada) and the regulations under those Acts. • •
DESTRUCTION
Authorization to destroy Narcotic and Controlled Drugs shall be obtained from: Office of Controlled Substances (OCS), Phone: 613-954-1541 or e-mail:
[email protected]. Record the name, strength, quantity, lot number and expiry date of the drugs destroyed. There must be one list for drugs from inventory and a separate list for drugs returned by patients, both of which must be kept on file for at least two years. The destruction must render the product unusable and must be witnessed by another health care professional. Prior approval for the destruction of Targeted Substances is not required. Refer to NSCP Policy: Destruction of Unusable and Expired Narcotic and Controlled Drugs
Summary of Federal and Provincial Laws and Regulations Governing the Dispensing of Prescription Drugs in Nova Scotia
PRESCRIPTION MONITORING PROGRAM (PMP)
The drugs included in the Prescription Monitoring Program (PMP) are those that from time to time are recommended by the Program for inclusion in the list of monitored drugs. No pharmacist shall dispense a prescription for a monitored drug unless the prescription is written on the duplicate prescription form provided by the Program. The patient/patient’s agent shall sign the prescription before it is released to the patient/patient’s agent. The pharmacist is to submit prescriptions to the PMP using on-line adjudication at the time the prescription is dispensed and is to contact the PMP as soon as possible if they are unable to do so. Pharmacists may access patient profiles through the PMP’s e-Access, a secure web application, to ensure the appropriate use of and to reduce the misuse of monitored drugs. Further PMP information can be accessed at (902) 4967123 or www.nspmp.ca. Note: Some out of province practitioners participate in this Program. Prescriptions for patients written on the NSPMP duplicate prescription forms by these prescribers may be filled by Nova Scotia pharmacists.
DIVERSION
Report any loss, theft or forged prescription of Narcotic and Controlled Drugs and Targeted Substances within 10 days to the Office of Controlled Substances (OCS) and forward a copy to the NSCP. Loss and Theft Report Forms shall be submitted to the National Compliance Section, Office of Controlled Substances A.L.0300B, Ottawa ON K1A 0K9 or by e-mail:
[email protected] and to the NSCP. Loss, theft and forged prescriptions should be reported to the local police authority. Double doctoring of Narcotic and Controlled Drugs and Targeted Substances is illegal and should be reported to local police authority.
REVISED: APRIL 2015
Nova Scotia College of Pharmacists ~ Prescription Regulations Summary ~ Prescription Requirements Written Verbal Fax**
Classification/Description Narcotic Drugs *
YES
NO
Prescriptions to be 1 Narcotic: e.g. Cocaine, Codeine (Codeine written on a duplicate Rx Contin®), Hydromorphone (Dilaudid®, form approved by the Hydromorph Contin®), Morphine (M.O.S.®, NS Prescription MS Contin®, MS-IR®) Monitoring Program 1 Narcotic + 1 active non-narcotic ingredient: (PMP) For exemptions to e.g. Tylenol® #4, pms-Acetaminophen w PMP see Reference Key Codeine Elixir, Suboxone®
NO
Refills
Part-Fills
Records
NO
YES
Purchases: Require that a signature from a licensed pharmacist be provided to the supplier. All purchases for Narcotic Drugs, Narcotic Preparations and Controlled Drugs and their preparations, including Exempted Codeine Compounds, are to be recorded. The record should include the brand name, quantity, strength, the name of the supplier and the date received. Records, including printed computer reports, must be current and kept for at least 2 years. Sales: Sales reports are required by federal legislation for all Narcotic Drugs and Controlled Drugs - Part I. Retention: Prescriptions for Narcotic Drugs, Narcotic Preparations and all Controlled Drugs and their preparations may be filed together but must be filed in sequence and separated from all other prescriptions. Records of prescriptions dispensed must be kept for ten years from the date of the last transaction on the patient's record. The legal requirement to store the prescription is considered to be met if the prescription is scanned into a secure electronic database. Refer to the NSCP policy Record Retention: Electronic Storage of Prescriptions. Loss & Theft: Report any loss, forgeries or theft of Narcotic and Controlled Drugs using the Loss or Theft Report Form for Controlled Substances and Precursors within 10 days after discovery to the Office of Controlled Substances at the address indicated on the forms and forward a copy to the NSCP. Narcotic and Controlled Drug Reconciliation: The following must be performed in accordance with the NSCP Council Professional Practice Policy - Narcotic and Controlled Drug Reconciliation: 1. Reconcile physical inventory with computer manual perpetual inventory. 2. Reconcile invoices with purchase records. 3. Reconcile sales reports with filed prescriptions. 4. Reconcile purchases and sales records.
YES 2.(a)(d)
Written instructions must be included on the original prescription specifying the total quantity of the drug, the amount to be dispensed for each fill and the interval between each fill. This can be done by assigning each part-fill a new prescription number OR a new transaction number referenced back to the original prescription number. A hard copy of the original prescription must be generated for each part-fill. Record the date of the part-fill, prescription number, quantity dispensed, and the pharmacist's initials on the hard copy. A signature must be obtained from the individual to whom the part fill is released. Transfers of "part-fills" and undispensed prescriptions are not permitted.
2.
All narcotics for parenteral use: e.g. Fentanyl Injection, Alfentanyl Injection, Meperidine Injection
All products containing: Diamorphine (Heroin) - Hospital Only Hydrocodone (Tussionex®, Hycodan®, Dimetane® Exp. DC), Oxycodone (OxyNeo®, Oxy-IR®, Percodan®, Percocet®, Endocet®) Nabilone (Cesamet®), Pentazocine (Talwin®) Methadone (Metadol®) - see Reference Key 1.
Narcotic Preparations * Verbal Prescription Narcotics : 1 narcotic + 2 or more non-narcotic ingredients: e.g: Fiorinal C®, 292® Dimetapp-C®, Tylenol® #2 & #3, 282®, and Robitussin AC®
NOTE: The pharmacist may change a prescription to a part-fill provided the total quantity ordered by the prescriber is not exceeded. The pharmacist, after discussion with the patient/patient agent, may dispense a smaller quantity for economic, patient safety or other reasons based on their professional judgement. The pharmacist must write the part-fill instructions on the original prescription as noted above. Third party insurers may not reimburse the cost of extra dispensing fees.
YES
NO
NO
2. (a)(d)
YES 2.(a)(d)
YES 2. (a)(d)
NO
Exempted Codeine Compounds (OTC):
REFERENCE KEY:
Codeine up to 8mg/solid dosage form or 20mg/30mL liquid + 2 or more active nonnarcotic ingredients: e.g: Atasol® 8, Tylenol® #1 or 222®
Controlled Drugs - Part I * 1 or more controlled drugs eg: Dextroamphetamine (Dexedrine®), Methylphenidate (Concerta®)
1. Methadone Prescribers must have special authorization specific to the treatment of pain or substance dependence or both, issued by the Office of Controlled Substances (OCS) to prescribe methadone for that specific indication. Pharmacists may contact Health Canada’s Methadone Program at (613) 946-5139 or toll free at 1-866-358-0453 or at
[email protected] for verification. YES
NO
NO
NO
2. (a)(d)
YES 2. (a)(d)
YES 2. (a)(d)
YES 2. (a)(d) for written prescriptions only
YES
NO
NO
NO
2. (a)(d)
YES 2. (a)(d)
YES 2. (a)(d)
YES 2. (a)(d)
Controlled Drug Preparations Part I 1 controlled drug + 1 or more active noncontrolled drug(s)
Controlled Drugs - Part II * Barbiturates and their salts and derivative: e.g. Phenobarbital, Butorphanol
2. Exemptions to the NS Prescription Monitoring Program (PMP) include prescriptions for Controlled Drugs and Substances: (a) from veterinarians for their patients (birds, fish, animals) (b) for inpatients of hospitals as defined by the Hospitals Act (c) for testosterone compounded by a pharmacist (e.g. creams) for topical application for local effect to the vaginal area (d) for residents in a licensed home as defined by the Homes for Special Care Act. Note: this exemption applies only to the licensed homes found in the NS Directory of Nursing Homes and Residential Care Facilities and only as long as the residents of these homes have their medication administered to them by an authorized employee of the home. (e) for Benzodiazepines and other Targeted Substances. Note: This examption applies only to those pharmacies that have not yet connected to the provincial Drug Information System (DIS). For pharmacies that have connected to the DIS, prescriptions for Benzodiazepines and other Targeted Substances will be transmitted from the DIS to PMP. Refer to s. 2 (2) (b) and s. 13 (2) of the Prescription Monitoring Regulations NB: When filling prescriptions for these PMP exemptions, Federal Legislation must be followed. See CPS Appendices - Canadian Requirements for Narcotic and Controlled Drugs for a summary review of this information or refer to the Controlled Drugs and Substances Act and related Regulations.
Nalbuphine (Nubain®)
Controlled Drug Preparations Part II* Combinations containing 1 controlled drug + 1 or more active non-controlled drug: e.g. Fiorinal®, Bellergal® Spacetabs
Controlled Drugs - Part III * Anabolic Steroids:
YES
NO
NO
NO
2. (a)(c)(d)
YES 2.(a)(c)(d)
YES 2. (a)(c)(d)
YES 2. (a)(c)(d)
YES
YES
YES
YES
2. (e)
2. (e)
2. (e)
YES
YES
YES
e.g. Testosterone (Andriol®) - see Reference Key 2.(c), Androderm® Patch, Androgel®, Delatestryl®)
Benzodiazepines and other Targeted Substances *See 2.(e) Benzodiazepines, their salts and derivatives (EXCEPT clozapine and olanzepine): e.g. Alprazolam (Xanax®), Bromazepam (Lectopam®), Chlordiazepoxide, Clobazam, Clonazepam (Rivotril®), Diazepam (Valium®), Lorazepam (Ativan®), Oxazepam, Triazolam
Prescription Drugs (formerly Schedule F)
2. (e) Refills are permitted when the prescriber specifies the number of refills. A pharmacist may transfer a prescription for a targeted substance to another pharmacist, except in instances where a prescription has already been transferred.
YES
All drugs listed in the Prescription Drug List (formerly Schedule F) of the Food and Drug Act and Regulations.
*The products noted are examples only and all drugs in a given classification may not be listed. **Only in accordance with the NSCP Council Policy - Facsimile Transmission of Prescriptions.
Purchases: Require that a signature from a licensed pharmacist be provided to the supplier. All purchases must be recorded. The record will include the brand name, quantity, strength per unit, # of units/pkg. and # pkgs., the name of the supplier and the date received. Sales: Sales report not required for prescriptions but is required for sales to a pharmacy, a practitioner or a hospital. Retention: Records of prescriptions dispensed may be filed with regular prescriptions. Records of prescriptions dispensed must be kept for ten years years from the date of the last transaction on the patient's record. The legal requirement to store the prescription is considered to be met if the prescription is scanned into a secure electronic database. Refer to the NSCP policy Record Retention: Electronic Storage of Prescriptions. Loss & Theft: Report any loss, forgeries or theft using the Loss or Theft Report Form for Controlled Substances and Precursors within 10 days after discovery to the Office of Controlled Substances at the address indicated on the forms and copy to the NSCP.
Purchases: Signature not required for purchases. Sales: Purchase and sales reports are not required. Retention: Records of prescriptions dispensed must be kept for ten years years from the date of the last transaction on the patient's record. The legal requirement to store the prescription is considered to be met if the prescription is scanned into a secure electronic database. Refer to the NSCP policy Record Retention: Electronic Storage of Prescriptions.
April 2015
Prescription Regulations Summary
