Part G - Food & Drugs Act (Controlled Drugs)

Question 1

Part G of the FDA encompasses what class of drugs?

Answer 1

Controlled Drugs

Question 2

Define what a “preparation” is (as outlined by G.01.001 of the FDA).

Answer 2

a drug product containing a controlled drug & one or more active medicinal ingredients (in a recognized dose other than a controlled drug)

Question 3

Define what a “prescription” is.

Answer 3

authorization given by practitioner that stated amt. of a controlled drug be dispensed for the person or animal named

Question 4

Who can possess a controlled drug [G.01.005 (1)]?

Answer 4

-Those who require it for their business or profession

-Hospital employee or practitioner in a hospital

-Obtained controlled drug for their own use

-Practitioner of Medicine

Question 5

Only people who are able to produce / assemble / sell / provide / transport / send / deliver / export / import controlled drugs [G.02.001]?

Answer 5

Licensed Dealers

Question 6

Who can Licensed Dealers sell to?

Answer 6

1) Other Licensed Dealers

2) Pharmacists (except those named in notices)

3) Hospital Employees (but MUST be either Practitioner or Pharmacist within that hospital)

Question 7

What components of a written order are needed in order for a Licensed Dealer to sell or provide controlled drugs?

Answer 7

-Pt. I / II / III controlled drug

-Name & Qty. of controlled drug

-Signed & Dated (with signature verified)

Question 8

What components of a verbal order are needed in order for a Licensed Dealer to sell or provide controlled drugs?

Answer 8

-Pt. II / III controlled drug

-Name & Qty. of controlled drug

-Receipt within 5 business days (Sig. of Pharmacist or Practitioner who received drug, date, name & qty. of controlled drug)

Question 9

Licensed Dealers must record what information when conducting a general sale?

Answer 9

-Name of Drug / Form / DIN / Qty. / Strength

-# per package & # of total packages

-Name & Address of who it was sold to (& dated)

Question 10

Licensed Dealers must record what information when conducting a Verbal Order?

Answer 10

-Name of person placing order

-Date order was received

-Name of person recording the order

Question 11

Which division within Part G of the FDA targets us as Pharmacists?

Answer 11

Division 3 [G.03]

Question 12

What must Pharmacists keep on file once a controlled drug has been received [G.03.001]?

Answer 12

-Name & Qty. of controlled drug received

-Name & Address of person who sold or provided

-Date it was received

Question 13

In order to sell or provide controlled drugs to a person, a Pharmacist requires what from a written prescription?

Answer 13

-Signature of Prescriber & must be Dated (!!).

Question 14

In order to sell or provide controlled drugs to a person, a Pharmacist requires what from a verbal prescription?

Answer 14

-Ensure that the person they’re speaking to is the Prescriber.

Question 15

Pharmacists who sell or provide controlled drugs to Practitioners are required to keep a separate Narcotic / Controlled Drug File… What must be on this file?

Answer 15

-Name / Address of Practitioner & Date when drugs were provided

-Name & Qty. of controlled drug sold

Question 16

Pharmacists supplying hospital employees (ie. Other Pharmacists or Practitioners) with controlled drugs can only do so after the receipt of what?

Answer 16

-Written (NO VERBALS!!!), signed, dated & verified order.

Question 17

What is required in order for a Pharmacist to refill a prescription for a controlled drug?

Answer 17

-Refills listed on Rx

-Intervals between refills

-Pt. I drugs must be written

-Pt. II or III can be written or verbal

-Records of each refill

Question 18

Upon dispensing a drug from Pt. I of the schedule, what must a Pharmacist do?

Answer 18

-Record their name or initials

-Practitioner’s name, initials & address

-Pt. name & address

-Name / qty. / dosage form of drug

-Date dispensed

-Number assigned to order or Rx

Question 19

Verbals taken for controlled drug prescriptions must be reduced to writing & must contain what information?

Answer 19

-Pharmacist name or initials

-Practitioner name / initials / address

-Pt. name & address

-Name / qty. / dosage form of drug

-Directions

-Date dispensed (& date received)

-Rx number

Question 20

Pharmacist Managers are required to retain all controlled drug prescriptions for what length of time?

Answer 20

At least two years

Question 21

In accordance with G.03.012, the SCPP recently mandated what protective measure to prevent narcotic thefts?

Answer 21

Time-Delayed Safes

Question 22

G.03.013 requires that all narcotic losses / thefts be reported within how many days of discovery?

Answer 22

Within 10d of discovery (NOT NECESSARILY WITHIN 10d OF OCCURRENCE).

Question 23

G.03.014 permits Pharmacists to do what (returns & emerg stuff)?

Answer 23

-Return CD’s to Licensed Dealers

-Provide emerg. supplies to another Pharmacist

-Sell or provide to Minister

-Provide CD’s to authorized officials

Question 24

G.04.001 (3) outlines Practitioner administration rules… What human / animal conditions being treated allow for administration of a designated drug?

Answer 24

Humans: Narcolepsy, HK Disorders (kids), Epilepsy, Parkinsonism, Hypotensive States assoc. with Anesthesia.

Animals: Depression of Cardiac & Respiratory Centers.

Question 25

G.04.001 (4) outlines what “Designated Drugs” are… What are they?

Answer 25

-Amphetamines
-Benzamphetamine
-Methamphetamine
-Phenmetrazine
-Phendimetrazine

AND THEIR ASSOC. SALTS!!!

Question 26

G.05.003 (1-5) permits a hospital to provide all categories of CD’s to whom?

Answer 26

1-2) In / Out-Pt.’s upon written order of a Practitioner.

3) Emerg. supplies to Hospital Employee or Practitioner in a different hospital.

4) To a Pharmacist.

5) To a researcher of the hospital.

Question 27

G.06.004 states that CD’s can’t be what?

Answer 27

Advertised to the general public… Pkg. must also contain “C” in a diamond!

Question 28

Pt. 1 - Level 1 Controlled Drugs… What are they?

Answer 28

-Amphetamines
-Methylphenidate
-Phendimetrazine
-Phenmetrazine
-Pentobarbital
-Secobarbital

Question 29

Pt. 2 - Level 2 Controlled Drugs… What are they?

Answer 29

-Barbiturates (except LV. 1 Barbs)
-Thiobarbiturates
-Thiopental
-Chlorphentermine
-Diethylpropion
-Phentermine
-Butorphanol
-Nalbuphine

Question 30

Pt. 3 - Level 3 Controlled Drugs… What are they?

Answer 30

-Anabolic Steroids

Question 31

Are Pharmacists allowed to possess Restricted Drugs (Part J of FDR)?

Answer 31

NO!!!!

-Includes Amphetamines & LSD (Pt. I), Salvia Divinorum (Pt. II).