pharm regulations Flashcards
when prescriptions are needed for drugs DISPENSED to veterinary patients
prescription only drugs
-human labeled product: prescription required ELDU
-veterinary labeled products: Yes because Rx -only!
Over the counter:
-human products: prescription required ELDU
-veterinary labeled product: not required
-all off label and compounded drugs must require a veterinary prescription and must include proper label dispensing.
prescription refills
-can’t authorize indefinite use of a product, expire after a year, have to renew client- patient relationship.
Prescription Transfers
– Only a pharmacist can transfer a prescription, and it can only be transferred to another pharmacist.
– In some jurisdictions, veterinarians are NOT allowed to transfer prescriptions from one veterinarian to the other,
they need to have their own VCPR in order to fill (dispense) the prescription
-can transfer from vet to vet dependent of province
veterinary techs and giving phone orders
- A veterinary technician may, under the direction and supervision of a veterinarian, administer a drug, medicine,
appliance, or other application/treatment - A veterinary technician may not make a diagnosis or determine any course of treatment.
- ONLY THE VETERINARIAN CAN GIVE THE VERBAL ORDER FOR THE CLIENT’S PRESCRIPTION TO A PHARMACIST
dispensing
- In SK and AB (and some other provinces), Prescribing and Dispensing
are considered SEPARATE practices.
-Veterinarians are allowed to both PRESCRIBE and DISPENSE a drug,
providing they have a valid VCPR and the drug is medically warranted - In contrast, human MDs are NOT allowed to dispense drugs to patients
Legal requirements for a Prescription NEED TO KNOW
- Prescribing veterinarian & certified veterinary facility
- Veterinary contact information (phone number, address)
- Date of prescription
- Patient owner/agent (client) & address
- ID of individual patient or group of animals (and species)
- Drug prescribed:
– Brand name or generic name (or both)
– Strength / concentration (mg or mg/mL)
– Formulation (e.g., capsules, suspension, ointment))
-signa: directions for use: route, dose, frequency, duration, withdrawl times for food animals
-mitte: total quantity of the drug
* If generic available: Substitution (yes or no) of generic drug
-number of refills (zero if not specified), No REFILLS FOR NARCOTICS
-signature of the veterinarian
prescriptions for in-feed drugs food animals
- Animal production type
- Weight or age
- Type of feed
- Total amount of feed or feeding period
- Amount of drug used per tonne
– Typically parts per million (ppm, mg drug / kg feed) - Manufacturing instructions
- Cautions
- CgFARAD # if applicable
-for vets who will be doing this get extra training, if you screw up the Rx you can kill 1000 of animals not just one, much higher risk.
WHO CAN DISPENSE DRUGS?
- Dispensing is the provision of a drug product, either:
– “as is” in the manufacturer’s packaging, or
– repacking and labeling a product for use by the client. - Dispensing of drugs for animal treatment is often performed by a Veterinary Technician, but must be done
under the direct supervision of the veterinarian. - The veterinarian remains legally responsible for the dispensing of the drug from her clinic, regardless of who
actually performed the function
GENERAL DISPENSING GUIDELINES
-recommended to read label 3 times:
1. When take product from the shelf
2. When removing product contents from the bottle/vial
3. When replacing the product back on the shelf
Note the storage requirements:
-Temperature: Refrigerate:2-8C, Room Temp, 15-30C
-Moisture: Use air tight containers.
-Light: Use amber bottles and containers.
-Expiration: ENTIRE COURSE** of treatment must be completed before expiry date
Dispensing label information with original packaging
-A dispensing label which includes information specific to the prescription (and therefore not part of the manufacturer’s label information) must be attached to the drug packaging. If affixed to the manufacturer’s original package (don’t
cover important stuff!),
-name of owner or client
-name of perscribing vet and practice
-ID of patient
-total drug # dispensed
-directions for use in the perscribed animals, including dose, route, frequency and duration of treatment WRITTEN OUT NO ABBREVIATIONS
dispensing in NOT original stregnth (pill bottles, syringes)
-additional info required
* Name of drug dispensed (generic name or brand name) and strength or
concentration (e.g. 100 mg, 10 mg/mL)
* Drug Identification Number (DIN)
* Minimal withdrawal time (where applicable) as prescribed
* Storage precautions and any toxic warning or other precautions appearing
on the manufacturer’s label
– For sure: “For veterinary use only” & “Keep out of reach of children”***
* Expiry date??
- Who is responsible for regulating veterinary drug approvals in Canada?
- Health Canada*** → Health Products and Food Branch → Veterinary Drugs Directorate
- How can you easily identify which products are “drugs”? Will have a DIN number
- Who is responsible for regulating veterinary drug residues
and biologics (vaccine, antibodies, and diagnostic test kit)
approvals in Canada?
- Canadian Food Inspection Agency
- Centre for Veterinary Biologics (Ottawa)
- Who is responsible for regulating pesticide
products in Canada?
- Health Canada – Pest Management Regulatory agency
-cant use off label, dispense in original packaging, no partial package use
-has PID pest control product number
What are the primary differences for veterinarians
when prescribing/selling drugs and pesticides?
– Can’t legally use pesticides in any manner other than the product label (no extralabel use)
– Can’t dispense partial packages (i.e. one month supply only)
