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Under the bylaw of the vet profession who has to assume responsibility for making clinical judgment regarding the health of the animals and the need for medical treatment? and who has to follow that persons instructions?
- Client has to follow instructions
What are all the factors of a VCPR?
- vet has sufficient knowledge of the animals to initiate at least a general or preliminary diagnosis of the medical condition of the anima (ie doesnt have to examine all 500 animals but vet makes judgement based on their knowledge of that livestock setting ie farm)
- The vet must have recently seen and be personally acquanted wiht the keeping and care of the animals by exam or by medically appropriate and timely visits to the premisies where the animals are kept (has to have been there before)
- Vet is able to follow-up evaluation or emergency coverage of the event of adverse reaction or treatment failure
What should producers ensure and what are they responsbile for in a VCPR?
- Should ensure:
- biosecurity and herd-health program
- On-Farm Food Safety
- Responsible for:work with vet to ensure valid VCPR
- record keeping
- animal ID
- Proper disposal of products
- disposal of dead animals (drug residues, diseas. ie bald eagles died from eating euthenised animals that had drugs in them)
What are the vets role in a VCPR
- Diagnosis and treatment planning
- Establish VCPR and may not dispense drugs outside this
- relationship (and enfore it)
- Prescription (Px) of drugs and medicated feeds
- vaccine prescription
- Education of producer- withdrawal or withholding time
- report adverse reactions
- continuing eduaction (legislative requirement) @ least 20hrs
What are the roles of Feed manufactureres (mills etc) in the topic of drugs?
- May be adding OTC anitbiotics to feed for prevention, therapy or growth promotion
- add prescription antibiotics to feeds under vet's direction only
What are the roles of Nutritionists in the topic of drugs?
- may work directly with producer
- often working for manufacturers
- formulation of medicated diets
Summary of VCPR, what conditions must be met?
- Vet is responsible for clinical judgements ie animal health and treatment
- client agrees to follow vets instructions
- vet has sufficient knowledge of animals to have general Dx of condition
- vet has recently seen animals, personally acquainted with circumstances
- vet is available for followup emergencies
What are the conditions that a licensed livestock medicine outlet must meet to distribute drugs?
- the outlet must have a Production animal Medicine license PAM
- also the staff must be trained with a PAm qualification certificate
- have a thorough knowledge pf regulations and their responsibility
- A Pam certificate holder must be onsite at all times when drigs are being sold
- *Only the Pam certificate holder is permitted to explain withdrawal, toxicity, and other warnings
Define ELU (extra-label use)/ OLU of drugs
- same thing
- ELU: defined as using the drug in a way not described or consistent with manufacturer label, package insert, or product monopgraph approved by Health Canada
- -ie untested in species or given at does, duration, indication (for condition) not listed
- Or an unapproved drug used in a manner that has never been approved by any regulatory authority
- ie not tested or unlabelled in a specific species
What is the problem with ELU?
- Consumers are given the impression that many cases of violative drug residues in food products are the result of ELU by veterinarans
- However most medications used in food animals can be obtained OTC
When is a vet liable in a violative drug residue in food products? And when is a producer liable?
- When a veterinarian chooses to prescribe a drug ELU, the vet, not the producer is liable for violations
- If the producer uses the drug ELU without vet advice, the producer is liable
***What five principle constitute ELU?
- 1. Administration of drug to a species for which there is no specific approval
- 2. Admin by a non-approved route
- 3. Admin of a non approved dose or frequency
- 4. Admin for a drug for a disease not listed on the label
- 5. Admin of Human-labe drugs to animals
1. Administration of drug to a species for which there is no specific approval
What species are usually not on the label?
llamas, rabbits, ranched wildlife, exotics, pocket pets, often sheep and goats (it may be approved in a country where the species is more prominant)
Give an example for an ELU for
2. Admin by a non-approved route
Gentamicin is approved for intrauterine use in horses and cattle but is commonly prescribed as IV, IM or SC (sub cutaneous)
Give an example of an ELU for
3. Admin of a non approved dose or frequency
- ex Trimidox is approved for once daily use. Many references recommend twice daily, so vets may prescibe that way
- situation common in Canada because in many drugs only a single dose or frequency is on lavel, wheras in other countries a range is on label
How common is it to do the ELU of
4. Admin for a drug for a disease not listed on the label
- This is a really common practice!
- Vets do it all the time usually with good background knowledge of the pros anc cons
- Producers probably do it very frequently without doing it
- ie Pen-Aqueous (white penecilin) mastitis treatment in a cow would technically be ELU
5. Admin of Human-labe drugs to animals
How common is this in Food animals vs Companion animals?
- Not too common in food animals- some antibiotics used for specific conditions in calves, piglest etc
- very common in companion animals: many eye medications, insulin, many cardiac medications, a number of antibiotics, drugs for GIT fucntion, many anesthetics
Why not just ban ELU in food animals? CQM, CQA and the EU hae basically done this
- Impossible to practice state of the art vet medicine without
- excessive animal suffering (what about minor species with no labels!?)
- Angry clients- increased costs for vet Rx (paper work)
- Liability- vet did not follow most effective therapeutic regiments?
- Laveling (follows testing) can't leep up with research and empirical sucess
- Economic disincentve for manufacturers to test and label for minor species or for off-patent dugs
What is the ELU in the future?
- being scrutinized in Canada and elsewhere (more and more pressure to use less OTC)
- In Europe no antibiotics are sold OTC to farmers at all
- This approac presents many welfare issues: more disease because can not use proactively
What would be the economic costs of banning ELU and not letting OTC sales resume
Economic costs: reduced productivity requires veterinary prescription for every case (extra cost)
In Alberta what are the laws that regulate drug use in animals?
- Vet Professional act
- Pharmacy and Drug Act
- Animal Health Act