compounding 1

Question 1

veterinary medication classifications, and who regulates

Answer 1

-vhp (VDD)
-drugs (veterinary drugs directorate)
-biologics (CFIA)
-pesticides (pesticides mgmt regulatory agency)

Question 2

In order for a veterinarian to dispense/prescribe medication there needs to be a valid

Answer 2

V-C-P-R

Question 3

— Drugs are categorized (scheduled) based on…..

Answer 3

Safety concerns —
Abuse potential
Ability of a lay person to understand and execute directions for their use

Question 4

— Scheduling of drugs/products dictates………

Answer 4

How drug is ordered for dispensing —
How drug is obtained by the client from a clinic
How drug is to be stored (records)

Question 5

drug schedules may be found at

Answer 5

National Assoc. of Pharmacy Regulatory Authorities

Question 6

drug schedules

Answer 6

NAPRA 1,2,3, unscheduled

Question 7

NAPRA 1 schedule drug regulations. what types of drugs are in this category?

Answer 7

-Prescription needed for sale by Pharmacist
May be stocked and dispensed by rDVM at clinic
— Narcotics (N)
— Controlled (C1, C2, C3)
— Targeted substances (TS)

Question 8

NAPRA 2 drug regulations

Answer 8

Prescription not required
-However, must be dispensed by pharmacist ie. behind the counter

Question 9

NARPA 3 drug regulations

Answer 9

— Client may obtain at pharmacy without need of the pharmacist

Question 10

unscheduled drug regulations

Answer 10

— May be obtained at retail stores

Question 11

what drugs require labelling? what must be on the label? what is the exception?

Answer 11

All prescription medications (NAPRA I) require labeling

Name, strength and quantity of drug —
Name/address of dispensing veterinarian —
Date drug is dispensed and expiration date —
Identity of the animal (s)
Name of owner —
Directions for use of drug
Drug identification number (DIN) —
Storage precautions and other warnings

Exception is non-PDL medications that are: — Veterinary approved
Are in their original packaging —
States “veterinary use only”

Question 12

what type of drugs can be dispensed without a veterinary label?

Answer 12

Non-PDL drugs may be dispensed without a veterinary label

Question 13

what should we include with an extra-label drug that is dispensed?

Answer 13

-must label with new directions

Question 14

Veterinarians dispensing drugs shall create what?

Answer 14

written record (patient record)

Question 14

Veterinarians dispensing drugs shall create what?

Answer 14

written record (patient record)

Question 15

whose responsibility is it to communicate with the client on medication use

Answer 15

veterinarian’s

Question 16

why does client noncompliance with meds occur?

Answer 16

Health beliefs/disbeliefs
Communication problems —
Skills and experience
Dosage regimen
Challenging patient

Question 17

what type of communication generally works best to avoid noncompliance with meds?

Answer 17

Combination of written and verbal communication generally works the best
-Manufacturers material —
-Client handouts

Question 18

what is compounding?

Answer 18

According to CVMA Guidelines for the Legitimate Use of
Compounded Drugs in Veterinary Practice (2006):

— The combining or mixing together of two or more ingredients (of which at least one is a drug or pharmacologically active component) to
create a final drug in an appropriate dosage form”……….that is not in accordance with the approved label directions for use of the drug.

— “It can involve the alteration of the form or strength of a commercially available final formulations or the use of raw bulk chemicals (API)”.

Question 19

informed consent expectations for compounded drugs ie. what should be communicated to client? when is this not needed?

Answer 19

-Drug has not be approved by the VDD of Health Canada
-Efficacy of the drug may not be known; drug not rigorously tested
-Any potential ADRs that may be incurred with the compounded product

-Not required for routinely utilized compounded drugs analgesic and anesthetic drugs eg ketamine/valium in same syringe, dilution of narcotics

Question 20

when is a compounded product considered a controlled substance?

Answer 20

if ingredients contain a controlled substance

Question 21

rules around re-dispensing compounded products

Answer 21

-Vets may comp’d or obtain a comp’ded product from a pharmacist for use in their accredited veterinary facility (must label product with “in clinic use”)
-Can re-dispense to individual animals or group where a valid VCPR exists as long as records show original pharmacy making the product

Question 22

— Should the veterinarian report ADRs when using comp’ded products?

Answer 22

Reporting ADRs associated with comp’ded products to the VDD of Health Canada is voluntary, but is encouraged.

Question 23

Compounding for veterinary patients can be considered rational and legitimate drug therapy when…….

Answer 23

-Valid V-C-P-R exists including owner consent and risks noted
-Veterinarian (not pharmacist) driven; evidence-based
-Within confines of a legitimate practice and provincial/federal rules governing compounding are observed
-No approved animal drug, or similar, exists for the intended use —
eg. Potassium bromide, cisapride
-Approved drug is not ……
>Appropriate dosage form (Methimazole transdermal gel)
>Appropriate concentration (Metronidazole oral suspension-kittens) —
>Effective when used according to label
-Response to therapy can be monitored; clinical parameters
-Safety and efficacy been demonstrated
—

Question 24

do we need withdrawl times for compounded drugs ?

Answer 24

Withdrawal times need to be modified when using comp’ded drugs in food animals
— CgFARADTM won’t provide assistance with WDTs with comp’ded drugs

Question 25

Factors to consider when deciding if an activity is legitimate compounding……the following are not legitimate activities

Answer 25

-Compounding of drugs where the health of the animal was not threatened or suffering/death was not likely if there was failure to treat

-Comp’ding drugs for 3rd parties for resale
—
-Comp’ding on a commercial scale
—
-Failing to operate in accordance with Provincial laws
—
-Comp’ding in anticipation of receiving prescriptions, with some exceptions
—
-Comp’ding drugs from unapproved substances
—
-Comp’ded product mimics an approved drug
—
-Comp’ding drugs banned for use in food animals
—
-Cost driven
—
-Advertised to general public

Question 26

— Veterinary compounding decision-tree
(Recommended Rank Order)

Answer 26

1. Approved (DIN) veterinary product according
   to label directions
2. Approved (DIN) veterinary product in an extra-label manner (ELDU)
3. Approved (DIN) human product (ELDU)
4. Comp’d product that are reformulated from veterinary approved (DIN) products (ELDU)
5. Comp’d product that are reformulated from human approved (DIN) products (ELDU)
6. Comp’d products prepared from unapproved or approved bulk drug (ELDU)