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1

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

2

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

3

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

4

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

5

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.

6

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.

7

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.

8

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

9

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

10

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.

11

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

12

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.

13

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

14

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

15

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

16

does Health Canada need to give permission to destroy these drugs?

what info should be recorded?

No

pharmacist must recoid:
• Name, strength per unit, and quantity of the targeted substance to be destroyed;
• Ensure method of destruction conforms with federal, provincial and municipal environmental legislation;
• Record the date of the destruction;
• Destruction must be witnessed by a pharmacist, other health care professional or a practitioner; and,
• Immediately after the destruction, ensure you and the witness sign and print your names on a joint statement
• witnessed the destruction
• Drugs have been altered or denatured to such an extent that its consumption has been rendered impossible or improbable

17

Can CD&S be imported or exported? if so, what must happen?

Import: Canadian individuals
- Obtained pursuant to a Rx and labeled according to regulations
• For personal use, or traveling companion/animal
• Must be declared to customs
• Supply does not exceed 90 days or single course of treatment

Export – individuals or pharmacists
• Individuals should not mail controlled substances and drugs to individuals outside of Canada
• Pharmacists are not permitted to mail controlled substances and drugs to another country.
• This includes mailing prescriptions to a patient “vacationing” outside of Canada!

18

Benzodiazepines and Targeted Substances Regulations

Define Targeted Substances

• A controlled substance included in Schedule 1 (schedule 1 in the BTS Regulations!!!); or
• A product or compound that contains a controlled substance from Schedule 1
• Act as tranquilizers, have sedating effects
• These drugs usually end with the suffix ‘‐am’
• Examples, lorazepam, diazepam, clonazepam
T/C symbol

19

Pre Covid vs Covid regulations for prescribing CD&S

Pre COVID
• Pharmacist must not prescribe any drugs listed in
the schedules of the Controlled Drugs and Substances Act including but not limited to drugs listed in the Narcotic Control Regulations and the Benzodiazepines and Other Targeted Substances Regulations.

Health Canada exemptions:
• Permit pharmacists to extend prescriptions for CDS,
• Permit pharmacists to transfer prescriptions to other pharmacists
• Permit prescribers to issue verbal orders
• Permit pharmacy employees to deliver prescriptions of controlled substances to patients’ homes or other locations where they may be

20

what is special about Flunitrazepam?

in a list of its own because it is listed as an illicit drug under Schedule 1 of the CDS Act

21

BZD & TS: Guidelines for Pharmacy Practice

Dispensing

what types of Rx's are permitted?
where are they filed

– Pursuant to written, verbal, transferred or faxed prescription
– Prescriptions can be filed with PDL or CDS prescriptions

22

BZD & TS: Guidelines for Pharmacy Practice

Refills

are they allowed?
do they need intervals?
valid for how long?

– Are allowed as specified by practitioner (no interval required but must be honored if specified)
– Refills valid for 1 year (from the date the prescription was written)

23

BZD & TS: Guidelines for Pharmacy Practice

Transferring Targeted Substances

allowed?

– Similar Requirements as PDL drugs BUT may only be transferred ONCE.
– When taking a transfer for a BZD, always check to see if the pharmacy has the original or was it already transferred

24

BZD & TS: Guidelines for Pharmacy Practice

what info should be recorded for when a pharmacy needs o borrow some BZD tablets so they may fill an order at their pharmacy?

A pharmacist who sells, provides, sends, delivers or transports a targeted substance without a prescription must keep a record of the following information:
• (a) the brand name of the targeted substance or, if the targeted substance does not have a brand name, the specified name;
• (b) the quantity and strength per unit of the targeted substance;
• (c) the name and address of the person to whom the targeted substance was sold, provided, sent, delivered or transported; and
• (d) the date of the transaction.

• You need a written or verbal order to sell without a prescription (pharmacist‐pharmacist, pharmacist‐practitioner for office use)

25

Part G: Controlled Drugs Definitions

define controlled drug and preparation

Controlled drug
• Any drug or drug product that includes a drug in the schedules to Part mG

Preparation
• Contains 1 control drug and 1 or more active medicinal ingredients (other than a control drug & at recognized therapeutic dose) in same dosage form.

26

Part G: Controlled Drugs

How many schedule's and parts?
which part does each refer to?

1 Schedule ‐ 3 parts

• Part I (referred to as C1) – Amphetamines salts and derivatives
(methylphenidate), also pentobarbital, secobarbital,
• Part II (referred to C2) – Barbiturates (excluding above)
• Part III (referred to C3) – Anabolic Steroids ie. Testosterone

• Amphetamines are stimulants
• Barbiturates are sedatives used to depress the central nervous system. These drugs usually end in ‘-al’.
• Steroids are hormones and these drugs usually end in ‘-one’.

27

Part G: Controlled Drugs

Dispensing

- what types of prescriptions can be accepted?
- filing?
- refills and requirements?
- transfers?

• Require a written or verbal prescription prior to dispensing to a:
• Patient
• Practitioner for use in their office
• Hospital employee or practitioner (written order only)
• Prescriptions are filed separately from PDL
prescriptions

Refills
• Valid for one year from the date the prescription is written
• C1: No refills allowed if original prescription is verbal
• C2 & C3: Refills valid if the interval between refills is specified

Transferring of Controlled Drugs
• These drugs may not be transferred at all

28

read notes on OCP

ok