Federal Laws Flashcards
What is CDSA and what schedule of drugs fall in this category?
Controlled Drugs and Substances Act (CDSA)
Schedules I-IV
What is NCR, and what schedule of drugs fall into this category?
Narcotic Control Regulations (NCR) are a part of the CDSA
Has its own schedule, but it contains many CDSA Schedule I and II drugs
What is BOTSR, and what schedule of drugs fall into this category?
Benzodiazepines and other Targeted Substances Regulations (BOTSR)
Like Narcotic Control Regulations (NCR), they have their own schedule, but it aligns with CDSA IV drugs
What is FDA?
Food and Drugs Act (ACT) is a major piece of federal legislation that enables respcription.
What is the FDR?
Food and Drug Regulations (FDR) is used to regulate foods and drugs
What is the difference between Part C or G from the FDR (Food and Drug Regulations)?
Part C: regulates drugs
Part G: Like the other drug schedules, Part G drugs have their schedule that contains CDSA Schedule I-IV drugs
What are the dispensing requirements for drugs under different NAPRA drug schedules?
Schedule 1: require prescription
Schedule 2: require patient counselling by pharmacists before dispense
Schedule 3: must be sold in a licensed pharmacy or under the supervision of a pharmacist
Schedule 4: can be sold without professional supervision
What type of policies does part 1 of the CDSA act outline?
It outlines offences and punishments
What type of policies does part 2 of the CDSA act outline?
It outlines enforcement
What type of policies does part 3 of the CDSA act outline?
Disposition (forfeiting the proceeds of an offence or crime)
What type of policies does part 4 of the CDSA act outline?
Administration and compliance (standards for record-keeping and expectations for auditing)
What type of policies does part 5 of the CDSA act outline?
Gives the minister authority over your practice and license
What type of policies does part 6 of the CDSA act outline?
a) Compels pharmacists to provide info and take measures to prevent non-compliance
b) Empowers the federal cabinet to make or amend regulations
c) Exemptions by minister (s.56)
d) Supervisied consumption sites
e) Power to amend schedules
What is a section 56 exemption?
When declared by the minister, pharmacists are authorized to have an expanded scope of practice by not being forced to follow certain provisions outlined in the CDSA. They must also have a time limit (cannot be effective indefinitely)
What types of drugs are included in each CDSA schedule?
Schedule 1: opiods, cocaine, amphetamines
Schedule 2: synthetic cannabinoids
Schedule 3: Methylphenidate
Schedule 4: Barbiturates, benzodiazepines, anabolic steroids
Schedule 5: pre-cursor substances for potent drugs (ex. fentanyl)
Schedule 6: relatively benign precursor substances (HCl, lactose)
Describe what groups are affected by each division in Part G of the FDR act?
Division 1: General
Division 2: Licensed Dealers
Division 3: Pharmacists
Division 4: Other Practitioners
Division 5: Hospitals
Division 6: General
What drugs are midwives or podiatrists not allowed prescribe according to Part G from the FDR act and the Narcotic Control Regulations?
Exclusions under FDR act:
Amphetamine
Benzaphetamine
Methamphetamine
Phenmetrazine
Phendimetrazine
Anabolic steroids
Exclusions under NCR:
Opium
Heroin
Coca leaves
Methadone
Buprenorphine
What drugs are nurse practitioners not allowed prescribe according to Part G from the FDR act and the Narcotic Control Regulations?
Exclusions under FDR act:
All anabolic steroids, except testosterone (NPs can prescribe testosterone)
Exclusions under NCR:
Opium
Coca leaves
What criteria must be met for narcotic prescriptions to be transmitted orally between practitioners?
a) The product contains two or more medicinal ingredients that are not narcotics
b) Not intended for parenteral use
c) It does not contain heroin, hydrocodone, hydromorphone, methadone, oxycodone, or pentazocine
What is special about the sale of low-dose codeine preparations in terms of their sale?
They can be sold without a prescription with the following requirements in place:
No more than 8mg codeine/tablet or 20mg/30mL liquid
Two or three additional non-narcotic drugs in specific portions
Need to label preparation with a warning label about codeine and dangers of use in children without professional consultation
What does Part J of the SCPP Regulatory Bylaws say about low dose codeine products?
Prohibits pharmacy professionals form selling or storing low dose codeine preparations in pack sizes exceeding 50 units or 100mL
Can low dose codiene products be advertised?
No, these products must also be kept away from public eye, so they go behind the counter
How long do pharmacists need to retain records of purchasing and sale of narcotics?
2 years, and any thefts or losses need to be reported within 10 days of discovery
What records should pharmacists keep on receipt of a controlled drug from a licensed dealer?
Keep a record of the following:
Name and quantity of drug received, the name and address of the person who sold or provided it, and the date it was received
What are the special instructions for the storage of controlled drug prescriptions?
Need to be filed in a particular file (N/CD file) in chronological order as to date and the prescription number.
Pharmacist manager to keep records for 2 years
What are the designated drugs under Part G of the FDR act?
Amphetamines
Benzaphetamines
Methamphetamines
Phenmetrazine
Phendimetrazine
and all of their salts
Are pharmacists allowed to possess restricted drugs outside of a pharmacy?
No, they are not entitled to possession
Part 1 amphetamines, LSD
and
Part 2 salvia divinorum
