compounding 1 Flashcards
veterinary medication classifications, and who regulates
-vhp (VDD)
-drugs (veterinary drugs directorate)
-biologics (CFIA)
-pesticides (pesticides mgmt regulatory agency)
In order for a veterinarian to dispense/prescribe medication there needs to be a valid
V-C-P-R
Drugs are categorized (scheduled) based on…..
Safety concerns
Abuse potential
Ability of a lay person to understand and execute directions for their use
Scheduling of drugs/products dictates………
How drug is ordered for dispensing
How drug is obtained by the client from a clinic
How drug is to be stored (records)
drug schedules may be found at
National Assoc. of Pharmacy Regulatory Authorities
drug schedules
NAPRA 1,2,3, unscheduled
NAPRA 1 schedule drug regulations. what types of drugs are in this category?
-Prescription needed for sale by Pharmacist
May be stocked and dispensed by rDVM at clinic
Narcotics (N)
Controlled (C1, C2, C3)
Targeted substances (TS)
NAPRA 2 drug regulations
Prescription not required
-However, must be dispensed by pharmacist ie. behind the counter
NARPA 3 drug regulations
Client may obtain at pharmacy without need of the pharmacist
unscheduled drug regulations
May be obtained at retail stores
what drugs require labelling? what must be on the label? what is the exception?
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”
what type of drugs can be dispensed without a veterinary label?
Non-PDL drugs may be dispensed without a veterinary label
what should we include with an extra-label drug that is dispensed?
-must label with new directions
Veterinarians dispensing drugs shall create what?
written record (patient record)
Veterinarians dispensing drugs shall create what?
written record (patient record)
whose responsibility is it to communicate with the client on medication use
veterinarian’s
why does client noncompliance with meds occur?
Health beliefs/disbeliefs
Communication problems
Skills and experience
Dosage regimen
Challenging patient
what type of communication generally works best to avoid noncompliance with meds?
Combination of written and verbal communication generally works the best
-Manufacturers material
-Client handouts
what is compounding?
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)”.
informed consent expectations for compounded drugs ie. what should be communicated to client? when is this not needed?
-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
when is a compounded product considered a controlled substance?
if ingredients contain a controlled substance
rules around re-dispensing compounded products
-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
Should the veterinarian report ADRs when using comp’ded products?
Reporting ADRs associated with comp’ded products to the VDD of Health Canada is voluntary, but is encouraged.
Compounding for veterinary patients can be considered rational and legitimate drug therapy when…….
-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
do we need withdrawl times for compounded drugs ?
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
Factors to consider when deciding if an activity is legitimate compounding……the following are not legitimate activities
-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
Veterinary compounding decision-tree
(Recommended Rank Order)
- Approved (DIN) veterinary product according
to label directions - Approved (DIN) veterinary product in an extra-label manner (ELDU)
- Approved (DIN) human product (ELDU)
- Comp’d product that are reformulated from veterinary approved (DIN) products (ELDU)
- Comp’d product that are reformulated from human approved (DIN) products (ELDU)
- Comp’d products prepared from unapproved or approved bulk drug (ELDU)
