Pharm 2 - Food safety

drraythe's version from 2015-11-09 21:15

Food Safety General

Question Answer
What is an example of a drug which used to be used as a growth promoter, but is now illegal?Clenbuterol (a β2 agonist) It leaves residues in the meat which can harm the consumer & also can harm the beef (although ↑ meat & ↓ fat, also open airways → ↑ resp infxn)
What are some ways a drug could be used which would be considered extra-label?Use in a diff sp than on label, or used for a diff indication than that which is on the label, or used in a different dose/concentration, or administration...etc
What are OTC drugs?Over The Counter drugs
What should you know about OTC drugs?They are the majority of animal drugs sold in the US & they can leave undesirable residues if not used accordingly to label
**What are the ABx which are not allowed for use in food animals?Chloramphenicols
Nitroimidazoles (Metronidazole)
Glycopeptides (Vancomycin)
**What are the hormones/steroids which are not allowed for use in food animals?Diethylstilbestrol (DES)
**What are the anti-inflammatory drug which are not allowed for use in food animals?Dipyrone (NSAID that makes animals DIPY)
**What are the antiviral drugs which are not allowed for use in food animals?Amantadine & Neuraminidase Inhibitors
The dose-response assessment accounts for what 2 things, according to him?The species & the age of the animal
So the animal eats/ is orally given some sorta drug. The oral bioavailability depends on what 4 things?(1) Composition of the feed (if it was added to feed or on some feed)
(2) ABC transport substrates: Non-consistent (the ABC transporters vary from species to species)
(3) Pre-systemic clearance in ruminants (their rumen bacteria break down the drug)
(4) Biotransformation: (species differences for this too)
Risk characterization 1st considers the species & age...then looks at what 2 things in the feed?(1) Identification of critical feed materials (we THINK this means you find the stuff that is critical - relevant - in the feed. PROBABLY toxins/chemicals/etc)
(2) Maximum Levels (or whatever crap he's talking about) per feed material (considering total exposure)
What are 3 criteria to consider when rating toxicological effects?(1) Clinical adverse effects
(2) Impairment of productivity
(3) Impairment of reproductivity (trans-generational effects)
What is AMDUCA?Animal Medical Drug Use Clarification Act
Who has published regulations for extra-label drug use?FDA/CVM
What are the stipulations set by the FDA/CVM in the Animal Medical Drug Use Clarification Act (AMDUCA) on how to use drugs extra-labelly? (4)(1) Valid veterinarian-client-patient relationship & careful Dx
(2) No currently marketed drug for the dz, or recommended dose is ineffective (w/o definitive Dx, can't use drug in an off-label manner)
(3) Records & other measures to identify the treated animals
(4) Significant extended withdrawal period, no illegal residues
**Drugs that cannot be used extra-label → Approved drugs (can use in food producing animals, but NOT in extra label manner) are?Enrofloxacin
Sulfonamide drugs
Medicated feeds
**What should you know about giving food animals Enrofloxacin?Under category "Approved drug for food animal, but NOT for extra-label use"
Only use in beef cattle & swine according to the label
**What should you know about giving food animals Sulfonamide drugs? (3 specifics)Cannot use in an extra label manner
Can use in certain food producing animals, but ONLY in lactating dairy cows according to the label
**What should you know about medicated feeds & food animals?FDA will allow extra-label use in minor species, but not in major species
**What should you know about Phenylbutazone?This drug is NOT approved in food animals & NOT approved to use extra-label, except in 1 specific situation: You CAN use them & use them extra-label, ONLY in DIARY cows UNDER 20 MONTHS OLD! (Only young cows are Phen)
What is ELDU?Extra-Label Drug Use
**If you have a question about using drugs extra-labally, who do you ask?FARAD
What is the most common drug family detected in milk & meat?β-lactams
What food residues are common in goats?Ivermectin & ABx
What drugs CAN be used in dairy cattleSulfonamides

Undesirable Substances & Pesticide Residues

Never seen these asked on an exam, but just in case
Question Answer
What are Mycotoxins which are "undesirable substances & pesticide residues"?Aflatoxin B1
Deoxynivanelol (DON)
Fumonisins (FB1-4)
Zearalenone (ZEN)
Ochrotoxine A (OTA)
Fusarium toxin T2
(Ergot will fusa the ORCHROstra into a FUMing ZEAl of AFLunece & DEOs)
What are Organic contaminants which are "undesirable substances & pesticide residues"?Dioxins
Polychlorinated Biphenyl (PCB)
What are Inherent Plant Toxins which are "undesirable substances & pesticide residues"?Glucosinolates (in garlic mustard)
Alkaloids (Vinca alkaloids)
Pyrrolizidines (St. John’s wort)
Gossypol (ALKALine Glucose in SAP makes me PYRR w/ GOSSYP)
What are Botanical Impurities which are "undesirable substances & pesticide residues"?Datura
Castor oil
Camelina sativa
(Dat castor is impure, Alaria the mad camel covered in mustard told me so)
What are ions & elements which are "undesirable substances & pesticide residues"?Arsenic

Withdrawal Times

Question Answer
Definition of withdrawal timeThe interval between the time of the last administration of a registered compound & the time when the animal products can safely be consumed
What are some czs of there being food residues?Not following the label WDT (withdrawal time)
Extralabel use w/o adjusting the WDT
Environmental contamination
Feed contamination
Emergency Tx of wounded & sick animals (lack of records or animal ID)
Slaughter of unidentified animals
1st step in determining the withdrawal time for an ↑ dose of drugs?Contact FARAD/ the drug company
**If you need to determine the WDT of an ↑ dose of a drug & you cannot contact FARAD or the drug company, what do you do?1st assume that it takes 5 half-lives for the drug to be eliminated from the body (e.g. if the label WDT is 20 days for a drug, then the estimated half-life is 4 days (bc 20/5 = 4) )

If you need to give the animal twice the label dose, just add 1 half-life to the label WDT of 20 days (so instead of starting w/ 100 to count down for half-life, start w/ 200, so instead of a WDT 20, you'd make it 24 bc you added another half-life bc you doubled the dose)
If you ↑ dose, need to?

The above graph WILL be on the exam. Get to know it.
↑ withdrawal period

Maximal Residue Limit

Question Answer
What is an MRL?Maximal Residue Limit the maximum concentration of a residue, resulting from the registered use (NOT OFF LABEL) of an agricultural or veterinary chemical, that is recommended to be legally permitted or recognized as acceptable in or on a food, agricultural commodity, or animal feed.
How do you derive a MRL?Determine the Acceptable Daily Intake (ADI) & then the toxicology data (lab animal species - target species), No Observed Effect Level (NOEL) & the safety factors
What is NOEL?No Observed Effect Level