Pharm 2- Food safety

kelseyfmeyer's version from 2015-04-16 18:50


Question Answer
what is an example of a drug which used to be used as a growth promoter, but is now illegal?clenbuterol (a B2 agonist) It leaves residues in the meat which can harm the consumer, and also can harm the beef (although inc meat and dec fat, also open airways-->inc resp infxn)
what are some ways a drug could be used in a way 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
Definition of withdrawl timethe interval between the time of the last administration of a registered compound and the time when the animal products can safely be consumed
what is an MRL?maximal residue limits-- 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.
look at the withdrawl time chartunderstand that if you inc dose, need to inc withdrawal period, but NEVER DEC WITHDRAWAL PERIOD
how do you derive a MRL?determine the acceptable daily intake (ADI), and then the toxicology data (laboratory animal species - target species), no observed effect level (NOEL), and the safety factors
what is NOEL?no observed effect level
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, and they can leave undesirable residues if not used accordingly to label
**what are the ANTIBIOTICS which are not allowed for use in food animals?chloramphenicol - nitrofurazone/ furazolidone - nitroimidazoles (metronidazole) - glycopeptides (vancomycin)
**what are the hormones/steroids which are not allowed for use in food animals?diethylstilbestrol (DES) - clenbuterol
**what are the antiinflammatory drugs which are not allowed for use in food animals?dipyrone
**what are the antiviral drugs which are not allowed for use in food animals?amantadine and neuraminidase inhibitors
what are ions and elements which are "undesirable substances & pesticide residues"?arsenic, lead, fluorine, mercury, cadmium, nitrites e.a.
what are mycotoxins which are "undesirable substances & pesticide residues"?aflatoxin B1, deoxynivanelol (DON), fumonisins (FB1-4), zearalenone (ZEN), ochrotoxine A (OTA), ergot, fusarium toxin T2 (Ergot will fusa the ORCHROstra into a FUMing ZEAl of AFLunece and DEOs)
what are organic contaminants which are "undesirable substances & pesticide residues"?dioxins, polychlorinated biphenyl (PCB), furans a.o.
what are inherent plant toxins which are "undesirable substances & pesticide residues"?glucosinolates (in garlic mustard), alkaloids (vinca alkaloids), pyrrolizidines (St. John’s wort), saponins, gossypol a.o. (ALKALine GLUCOSe in SAP makes me PYRR with GOSSYP)
what are botanical impurities which are "undesirable substances & pesticide residues"?datura, castor oil, crotalaria, camelina sativa, madhuca, mustard a.o. ( Dat castor is impure, the mad camel covered in mustard told me)
the dose-response assessment accounts for what two things, according to him?the species and the age of the animal
so the animal eats/ is orally given some sorta drug. The oral bioavailability depends on what 4 things?(1) the 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 considers the species and age...and then looks at what two 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 (of whatever crap he's talking about) per feed material (considering total exposure)
what are three criteria to consider when rating toxicological effects?(1) clinical adverse effects (2) impairment of productivity (3) impairment of reproduction (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) a valid veterinarian-client-patient relationship and careful diagnosis (2) no currently marketed drug for the disease, or recommended dose is ineffective (w/o definitive diagnosis, can't use drug in an off-label manner) (3) records and other measures to identify the treated animals (4) significant extended withdrawal period, no illegal residues
**Drugs that cannot be used extralabel--> 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 extralabel use" and he says: only use in beef cattle and swine according to the label
**what should you know about giving food animals sulfonamide drugs? (3 specifics)cant use in an extra label manner, can use in certian food producing animals, but ONLY in lactating dairy cows according to the label: sulfamethoxine - sulfabromomethazine - sulfaethoxypyridazin
**what should you know about medicated feeds and food animals?FDA will allow extralabel use in minor species, but not in major species
**what should you know about phenylbutazone?This drug is NOT approved in food animals, and NOT approved to use extralabel, except in one specific situation: you CAN use them AND use them extra label, ONLY in DIARY cows UNDER 20 MONTHS OLD!
what is ELDU?extra label drug use
**If you have a question about using drugs extralabally, who do you ask?FARAD
what is the most common drug family detected in milk and meat?beta lactams
what food residues are common in goats?ivermectin and Abx
what are some causes of there being food residues?not following the label WDT(withdrawl time), extralabel use without adjusting the WDT, environmental contamination, contamination of feed, emergency treatment of wounded and sick animals, slaughter of unidentified animals
first step in determining the withdrawl time for an increased dose of drugs?contact FARAD/ the drug company
**if you need to determine the WDT of an increased dose of a drug, and you cant contact FARAD or the drug company, what do you do?first 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 one half-life to the label WDT of 20 days (so instead of starting with 100 to count down for half life, start with 200, so instead of a WDT 20, you'd make it 24 because you added another half life bc you doubled the dose)

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