Drug directorate, laws & labels Flashcards
What does a “drug” include?
Any substance sold or manufactured, sold, or represented for the use in:
- diagnosis, tx, mitigation, or prevention of a disease, disorder, abnormal physical state, or its symptoms in humans or animals
- restoring, correcting or modifying organic functions in humans or animals
- disinfection in premises in which food is manufactured, prepared, or kept
What are the 5 classes of drugs by the National food and drugs act?
- prescription & non prescription pharmaceuticals
- biologically derived products (blood, biotechnology, vx)
- tissues and organs
- disinfectants
- radiopharmaceuticals
How are natural health products classified?
> By the food and drugs act - considered drugs
Natural health products regulations - natural health products
Food and drug regulations - not drugs
What does health canada do?
responsible for protecting human and animal health and the safety of Canada’s food supply - evaluate and approve health products for sale, decide what medicinal ingredients require rx, cannot sell products without authorization of HC
What is the VDD?
Veterinary Drug Directorate - division of HC
What is the role of the VDD?
- evaluate and monitor safety, quality, and effectiveness of vet drugs
- set standards and promote prudent use of vet drugs administered to food producing and companion animals
What does the VDD actually do?
- approve new vet drugs
- ensure drugs are safe and effective
- sets maximum residue limit (MRL), which then determines withdrawal period (WP or WT)
- inspect pharmaceutical plants to ensure QC present
- monitor adverse drug reactions (ADR)
- authorize emergency drug releases (EDR)
What is pharmacovigilance?
collection and analysis of suspected adverse drug reactions
What is the purpose of pharmacovigilance?
monitor safety and efficacy of vet drugs & safety of humans handling the products and consuming food from treated animals
What is an emergency drug release?
authorization to allow the manufacturer of a new drug to sell a limited quantity of new drug to vet practitioner - not marketed in canada and requested by vet for purpose of diagnosing or treating a medical emergency in a patient under his/her care
What is considered off label use? (ELDU)
administered differently than what is on the label - species, dose, route
What is considered a compounded drug?
combining or mixing of 2 or more ingredients (one is a drug) to create a final product in an appropriate form for dosing
What are some reasons for compounding?
- combine 2 or more drugs in one syringe
- make a “sweat” ointment
- drug is not available commercially
- remove a component that patient has allergies to
What happens with the development of a new drug?
- discover or synthesize a new drug
- evaluate safety, efficacy, dosage, etc
- submit data to VDD who gives it a DIN if approved
- continued surveillance
What 15 things are required on a drug label/insert?
- Trade/Brand Name
- Generic Name
- Concentration
- VDD Classification
- DIN
- Veterinary Use Only
- Total Amount of drug
- Drug Company Name
- Indications
- Dosage and Administration
- Warning
- Contraindications and Cautions
- Storage Instructions
- Lot Number
- Expiration Date
What is the trade or brand name?
proprietary - legally owned by the company - indicated by a symbol (Baytril)
What is the generic name?
non-proprietary - active ingredients (may be actual chemical name but usually shorter) (enrofloxacin)
What is the VDD classification?
category of drugs that the VDD assigns - “broad spectrum antibiotic”
What should be included in dosage and administration?
species, amount, route, any restrictions
What is withdrawal time?
time between last administration of the drug until any food products can be used for human consumption - applies to specific bottle dosing only
What is maximum residue limit?
level of drug residue that could safely remain in the tissue or food product derived from an animal that has been treated with a drug - ultimately determines the WT
What are the 2 acts used by HC for definitions of categories of drugs?
food and drugs act
controlled drugs and substances act
What are the 2 categories of veterinary drugs?
non-scheduled drugs
scheduled drugs
What are considered non scheduled drugs?
= Over the counter (OTC)
safe to use with a very low potential for toxicities or addiction (not on prescription drug list, certain pesticides and parasiticides)
