Unit 1

Question 1

Definition of Drug 1 (according to Food and Drug Act)

Answer 1

Substance/mixture of substances manufactured, sold or represented for use in:
1) diagnose, treatment, mitigation, or prevention of disease , disorder abnormal state/symptoms in humans/animals

Question 2

Definition of Drug 2

Answer 2

Substance/mixture of substances manufactured, sold or represented for use in:
2) restoring, correcting or modifying organic functions in human beings/animals

Question 3

Definition of Drug 3

Answer 3

Substance/mixture of substances manufactured, sold or represented for use in:
3) Disinfection of premises in which food is manufactured, prepared or kept

Question 4

Classifications of Drugs

Answer 4

1) Prescription/non-prescription
2) Biologically derived products (vaccines)
3) Tissues and organs (transplants)
4) Disinfectants
5) Radiopharmaceuticals (chemotherapy)

Question 5

Are natural products considered drugs?

Answer 5

Yes according to the Food and Drug Act
No according to Natural Health Products

Question 6

What does Health Canada do?

Answer 6

Protect humans/animals health and safety of Canada’s food supply.
—Have authority to evaluate safety and efficacy of products. Also decide prescription medicinal ingredients
HAVE to have authorization/license from them to sell these products in Canada

Question 7

What is the VDD?

Answer 7

The Veterinary Drug Directorate
-branch of Health Canada dealing with veterinary products
-Collaborates with others

Question 8

What are some roles of the VDD?

Answer 8

-Protects by monitoring safety, quality and effectiveness of drugs
-sets standards/promotes prudent use to any animal (responsible)
-Approves new drugs
-Sets maximum residue limit, determines WT
-Inspect pharmaceutical plans to ensure quality control in distribution
-Monitors Adverse Drug Reactions
-Authorize Emergency Drug Release

Question 9

What is Pharmacovigilance?

Answer 9

Post market surveillance. Collection/analysis of ADR’s

Question 10

Emergency Drug Release (EDR)

Answer 10

Authorization to permit manufacturer of new drug for purpose of diagnosing/treating emergencies

Question 11

Extra Label Drug Use (ELDU)

Answer 11

Off label use.
Differently administered from what is on label

Question 12

Compounding Drugs

Answer 12

“Combining/mixing 2 or more ingredients to create final product in appropriate form for dosing”
All prescription-only done by vet or pharmacist

Question 13

Reasons for compounding drugs?

Answer 13

-need different strength
-needs different dosage not usually available
-toxins/patient is allergic
-easier to administer

Question 14

Some examples of compounding

Answer 14

-Mixing injectables in a single syringe
-creating oral suspension from crushed tablets/solution
-adding flavour
-mixing solutions for ears

Question 15

What goes into New Drug Development?

Answer 15

1) discover/synthesize new drug
2) Evaluate safety, efficacy, dosage, etc… using lab to test
3) Submit data to VDD-gives DIN if approved
4) Continued surveillance by monitoring adverse reactions/complaints. Manages recalls

Question 16

Trade/Brand Name

Answer 16

-proprietary= company legally owns
-indicated through symbols: TM, R, or *
Ex: clavamox*

Question 17

Generic Name

Answer 17

-Non-proprietary
-Active ingredients
Ex: amoxicillin

Question 18

Concentration

Answer 18

-Found on front/side under medicinal ingredients
Ex: each ml contains/tablet, __ mg/ml, mg/tablet

Question 19

DIN

Answer 19

-computer generated 8 digit # on label of all approved Canadian drugs
-Uniquely identifies following: manufacturer, product name, active ingredients, strength, pharmaceutical form, route

Question 20

VDD Classification

Answer 20

-Category of drug that the VDD assigns
Ex: broad spectrum

Question 21

What is something EVERY VETERINARY drug needs on it?

Answer 21

Veterinary Use Only

Question 22

Total Amount

Answer 22

-Volume or tablet # in package
Ex: 100ml or 250 tablets

Question 23

What would “Zoetis” on the package be indicating?

Answer 23

Drug Company Name/Address

Question 24

Indications

Answer 24

What the product is used for

Question 25

Dosage/Administration

Answer 25

-shows species, amount, route, restrictions

Question 26

Warnings

Answer 26

-For human handling/use
-Withdrawl times may be under warnings

Question 27

Withdrawl Time/Period (WT/WP)

Answer 27

-Applies to bottle dose only
-Equine performance have own booklets

Question 28

What is the Maximum Residue Limit?

Answer 28

-Level of residue that cane safely remain in tissue/food product from animals treated
—> considered to pose no adverse health effects if ingested daily
-Set by Health Canada

Question 29

What might the label not always have?

Answer 29

Contradictions/Cautions

Question 30

What are the different storage instructions?

Answer 30

-Refrigeration—> 2-8C
-Cool—> 8-15C
-Room Temp—> 15-30C
-Protect from light—> amber bottle, often boxed

Question 31

What can we use to trace when/where drugs are manufactured?

Answer 31

Lot Number—> used in recalls

Question 32

Expiration Dates

Answer 32

-Company no longer guarantees potency/stability
-Do not sell!!!!
-Most important for: vaccines, antibiotics, vitamins/minerals