Lecture 8: CDSA Flashcards
What parts of Food and Drug Regulations pertain to controlled and restricted drugs?
Part J: Restricted Drugs
Part G: Controlled Drugs
CDSA also has Benzodiazepines and Other Targeted Substances Regulation
what is described here:
Provides a framework for use of substances that can alter mental processes and that may produce harm to health and to society when used without supervision.
• Provide mechanisms to ensure that use of substances is confined
to medical, scientific and industrial purposes.
• Provide enforcement measures to police and to the courts.
purpose of CDSA
Define Controlled Substance
Inspector
- Substances in Schedule I to VIII (these schedules are in the CDS Act)
- Substances that can alter mental processes and that may produce harm to health and to society when used without supervision (not the same as controlled drug)
A person designated as an inspector
Define Possession
- Having something in ones possession, or knowingly having it in any place whether or not he/she owns place for use or benefit of him/herself or others
- When pertaining to a group of persons , all shall have possession, even though only one is physically holding the item
Define Produce and Provide
Produce
• Manufacturing, synthesizing, or altering physical properties of substance, or
• Cultivating, propagating, or harvesting the substance or living thing which a substance may be extracted.
Provide
• Give, transfer, or make available.
Define Sell or Traffic
Sell
• Offer, expose, have in possession for sale
Traffic
• Referring to Schedule I to IV: Sell, administer, give, transfer, transport, send, deliver substance or sell an authorization to obtain a substance outside of the regulations.
Define Indictable offence and Summary Conviction
Indictable offence
• The more serious of the two types of offences, usually tried by a federal judge and carrying a heavier sentence.
Summary conviction
•A less serious offence resulting in lighter fines and sentencing.
Part ___ of the act defines punishments
I
Ex punishment: No person may posess any substance in Schedule I‐III (Except as auth. By Reg’s)
Schedule I:
• I/O=7 yrs or SC $1000‐$2000 and/or 6mos‐1yr prison
Schedule II:
• I/O=5yrs or SC $1000‐$2000 and/or 6mos‐1yr prison
Schedule III:
• I/O =3yrs or SC $1000‐$2000 and/or 6mos‐1yr prison
which parts of the Act deal with Administration and ?Compliance
II, III, IV, V
Part II
• Discusses search warrants and seizure of evidence
Part III
• Not relevant to pharmacy
Part IV
• Powers of inspector: Gives power and specifies what an inspector may or may not do.
• Assistance to inspector: Similar to previous must give assistance to inspector.
• Obstructing: No one may obstruct an inspector. I.e. Omitting details etc…
• Interference: No one may alter or interfere with anything seized by inspector
Part V
• Not relevant to pharmacy
What does Part VI say? (4)
- Regulations: indicates that the Governor in Council may add, change, remove regulations regarding any aspect of a controlled drug or substance.
- Paramountcy: CDS Act takes precedent in a conflict.
- Offence: No person can make a false or deceptive statement in any record required to be kept by this Act or Regulations.
- Schedules: May be changed at any time.
Guidelines for Pharmacy Practice
- what info must be recorded for sale for Narcs and Controlled Drugs Part I?
- where is this info kept?
- kept in a secure manner (safe)
- pharmacists have to record the sale
of some controlled drugs and substances in a ledger (separate from the patient medication/drug profile) when they dispense these drugs
Must record sale for Narcotics and Controlled Drugs Part I
• 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
what records must licensed dealers (wholesalers) keep?
how can loss or theft be protected aginst for deliveries?
Keep records of:
• Name and quantity of any drug received and who supplied it.
• Name and quantity of any drug supplied and who received it.
• Name and quantity of drug in stock at end of month.
• Keep records for AT LEAST 2 years.
- Take necessary steps to ensure safe keeping during transit.
- Incorporate an accurate record of each person in possession of drug until consignee.
can these drugs be advertised? any exceptions?
Cannot advertise to the public (that includes
name, price & quantity).
No advertising!
• Exception: Can advertise in medical and scientific journals
what steps to take if there is a loss of stock?
- must report any loss or theft to the federal Minister of Health within 10 days of discovery and a copy of the report is no 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
who can order these drugs and which forms of requests can be made?
In Alberta, only a pharmacist can order controlled substances and drugs.
- Written Request
- Electronic Request
- Verbal Request for Control Drugs in Part II and III of Schedule to Part G, BTS, VPN (Verbal Prescription Narcotics) are allowed
Must provide within 5 days back to the Wholesaler: • Record of receipt including: • Pharmacist Signature • Date received • Name and Quantity of Controlled Drug
- The invoice of ordered/received drugs must be kept for 2 years
- Record receipt of all controlled drugs and substances in a register for audit purposes
