Lecture 10: Narcotic Control Regulations to the CDS Act

Question 1

What is a narcotic?

Answer 1

substance set out in schedule or anything that contains a substance in the schedule (N1)

Question 2

What is a prescription (narcotic)

Answer 2

an authorization by a practitioner that a stated amount of narcotic be dispensed to person named in order

Question 3

what 3 requirements must be med for a drug to be a Verbal Prescription Narcotic (VPN)

Answer 3

1. In addition to a narcotic, contains 2 or more medicinal ingredients other than a narcotic in recognized therapeutic doses,
2. Is not intended for parenteral use, and
3. Does not contain:
   – Diacetylmorphine (Heroin)
   – Hydrocodone (Hycomine®)
   – Oxycodone (Supeudol®)
   – Methadone (Metadol®)
   – Pentazocine (Talwin®)

Question 4

is Tylenol 3 a VPN?

Tylenol 4?

Answer 4

Tylenol 3’s

• Codeine, caffeine, acetaminophen
• Can be verbally prescribed

Tylenol 4 not - only has codeine and acetaminophen

Question 5

Define Exempted Codeine Products (NPD/EC)

Answer 5

A preparation containing not more than 8mg or eq. of codeine phosphate per unit or not more than 20mg/30ml of liquid preparation, if:
• Two additional medicinal ingredients other than a narcotic where:
– One ingredient is present in reg. min. dose or
– 1⁄2 the reg. min. dose for both such ingredients
• Three additional medicinal ingredients other than a narcotic where:
– One ingredient is present in reg. min. dose or
– 1/3 the reg. min. dose for each ingredient

Question 6

Which Tylenol is an N1, VPN, NPD/EC

Answer 6

• N1 – Single entity narcotic, or narcotic containing only 1 other non‐narcotic medicinal ingredient. Ie. Tylenol #4
• VPN – A drug containing only 1 narcotic and more than 1 non‐narcotic medicinal ingredient as per definition. I.e.. Tylenol #3 (codeine + acetaminophen + caffeine)
• NPD/EC – Non‐prescription Exempted Codeine product. I.e. Tylenol #1

Question 7

what is special about NPD/EC’s?

• requirements for label?
• what concerns are there?

Answer 7

Label (36(1 b))
– List of all ingredients
– Manufacturer must include this statement: “This preparation contains codeine and should not be administered to children except on the advice of a physician or dentist.”

May dispense without a prescription but MUST document on patient record

Health Canada is proposing to amend the Narcotic
Control Regulations under the Controlled Drugs and
Substances Act to balance concerns that low‐dose codeine can lead to dependence and problematic use

Question 8

what info must be recorded for sale of Narcotics in a ledger?
who can order narcotics?

Answer 8

According to the CDS Act, pharmacists must record sale for Narcotics in a ledger (can be paper or electronic, separate from the patient medication/drug
profile) when they dispense these drugs
• Patient Name and Address;
• Name of drug, quantity and form;
• Dr. Name and Initials;
• Name and Initials of Dispensing Pharmacist;
• Date Drug Supplied;
• Individual Prescription Number

• In Alberta, only a pharmacist can order controlled drugs and substances (narcotics)
• Rules for destruction of unused products is the same as other CDS

Question 9

can narcotics be advertised?

Answer 9

Cannot advertise Narcotics to the public (that includes name, price & quantity). No advertising!
• Exception: Can advertise in medical and scientific journals

Question 10

what happens when there is a loss of stock for narcotics?

Answer 10

A pharmacist or practitioner must report any loss or theft of the Narcotic to the Federal Minister of Health within 10 days of discovery and a copy of the report is to be forwarded to the provincial or territorial pharmacy regulatory authority (ACP).
• Lost tablets for unknown reasons
• Internal theft/diversion
• Pharmacy robbed and supply is stolen

Question 11

who is authorized to a take a verbal Rx for VPN?

Answer 11

Only pharmacist and pharmacy students under supervision of pharmacist can prescribe

Question 12

Exempted Codeine Product - what schedule is it?

Answer 12

Schedule 2 in Alberta

Question 13

can refills or transfers occur?

Answer 13

Refills (37)
• No refills allowed past original quantity ordered (part fills)

Transfer
• Again, not mentioned in legislation so…Narcotics CANNOT be transferred.

Question 14

How should records of narcs be kept?

Is mailing of narcs outside of Canada allowed?

Answer 14

Records (40)
• Keep a separate prescription file for narcotics (& controlled)
• Filed by date and numerically by Rx number.
• Keep records for minimum of 2 years (past last change)

Mailing narcotics outside of Canada
• Not allowed according to the CDSA

Question 15

when can a pharmacist sell or provide a narc to a person?

how about heroin?

Answer 15

• If the pharmacist has received a written order or prescription for the narcotic that is signed and dated by
a practitioner and the signature of the practitioner, if not known to the pharmacist, has been verified by the pharmacist; or
• in the case of diacetylmorphine (heroin), if the pharmacist has received a written order or prescription for the narcotic that is signed and dated by a practitioner of medicine or a nurse practitioner and the signature of the practitioner, if not known to the pharmacist, has been verified by the pharmacist.
• Best practice: – “For Emergency Use” is usually written on this order if supplying for pharmacy or medical office use.
- Restrictions on practitioners are listed if they have been careless

Question 16

what are the guidelines for dispensing opioids?

Answer 16

• A relationship with the patient must be established and an assessment is needed.
• Must monitor individuals for the signs of opioid misuse, diversion, or addiction and take appropriate
action
• A written assessment needs to be done every time includes refills.
• Reviewing a patient’s Electronic Health Record is required every time an opioid is dispensed, so
it is up to the pharmacy professional to find that information. That might mean reaching out to
TPP Alberta, the prescriber, or to another pharmacy.
• Develop a written treatment plan for individuals using long term opioid therapy or for those determined to be at high risk of misuse or addiction.
• Exempted, non‐prescription, codeine‐containing products are included as part of the guidelines

Question 17

what is methadone used for?

what did Health Canada say in May 2018?

Answer 17

Methadone is used to manage pain or may be used to assist patients in managing their opioid dependency.
• As of May 2018, Health Canada no longer requires methadone prescribers to obtain a federal exemption under section 56 of the Controlled Drugs and Substances Act, and that oversight now lies with the various provincial regulators.

• Physicians who prescribe methadone in Alberta will still require approval from the College of Physicians and Surgeons of Alberta (CPSA) and will need to re‐apply to their college every 3 years. Current exemptions in place are still active but will need to be renewed as they expire.

Nurse practitioners (NPs) are not required to apply to CARNA for an authorization to prescribe methadone. Rather, they must complete education and preceptorship appropriate to the area of their prescribing and need only submit proof of this to CARNA upon their request. can write for methadone

Question 18

what should a pharmacist do when they receive a methadone prescription?

Answer 18

• When pharmacists receive a prescription for methadone from an Alberta physician, they should direct all confirmation requests to CPSA or email tgem
• If pharmacists receive a prescription from an NP for methadone, suboxone, or any other narcotic or controlled substance, they can check the nurse practitioner’s prescriber list on the ACP website.

Question 19

Guidelines for Pharmacy Practice: Buprenorphine

What is the difference between Suboxone® and Butrans®?

Answer 19

same ingredient of buprenorphine
Since SUBOXONE® includes naloxone as a misuse deterrent, it makes at-home treatment safer. (tablets, sublingual film)
- bup is partial agonist
- naloxone is an antagonist
- naloxone has no effect but if someone wants to abuse it (crush) it activates naloxone
- Suboxone is the best choice

Butrans is a transdermal patch and for pain managemnt but is easier to abuse

Question 20

what training is needed for buprenorphine prescriptions for prescribers?

Answer 20

Buprenorphine Prescriptions
• Physicians initiating prescriptions for buprenorphine (Suboxone®) for treatment of opioid dependence should:
• Complete the buprenorphine training required by Health Canada (CAMH‐Centre for Addiction and Mental Health).
• Methadone exemption not required

• Prescribers of buprenorphine (Butrans®) do not require a methadone exemption and no additional training is required by Health Canada
- tell prescriber it’s not for opioid dependency - for pain management
• Veterinarians do not require a methadone exemption to prescribe buprenorphine

Question 21

what training is needed for buprenorphine prescriptions for pharmacists?

Answer 21

Do Pharmacists need a methadone exemption or additional training to dispense these drugs?
• Any licensed pharmacist may dispense methadone and buprenorphine‐naloxone. No exemption or approval is required.

ACP needs you to read Medication‐Assisted Treatment for Opioid Dependence: Guidelines for Pharmacists and Pharmacy Technicians
- even if our opioids are for non-opioid dependence