-
how many names does any particular drug have?
at least 3 - chemical, generic, and at least one trade or proprietary name
-
what is the difference between a
generic name and a trade or proprietary name?
generic –is the common chemical name.
- trade – patented given to a drug by the
- manufacturer, which cannot be used by other manufacturers for that drug. capitalized.
-
if you had to use just the generic or just the trade name of a drug, which one would be best to pick?
generic – most widely recognized, no confusion as to which drug you are referring to.
-
what are the full names of these regulatory agencies, and what products do they regulate?
FDA – Food and Drug Administration – animal drugs, feed additives.
EPA – Environmental Protection Agency – animal topical pesticides.
USDA – United States Department of Agriculture –biologics – vaccines, serums, antitoxins, etc.
-
what is an “approved” drug?
approved by the FDA for a particular purpose in a particular species at a particular dose. has passed the legal approval process of research, clinical studies, field trials, etc.
-
what 2 things do researchers need to prove about a drug during the approval process?
safety – that it is safe to the animal patient, to humans handling it, and to the environment.
- efficacy – that it is effective – does
- what it claims to do.
-
what does “efficacy” mean?
effectiveness – the drug does what its label claims it can do.
-
is drug research and development fast, cheap, and easy?
no
-
should the government make drug companies give away drugs for free to anybody and everybody who needs them? Why or why not?
no. this would quickly bankrupt the drug companies, and then we would have no drugs at all.
-
once a drug company has developed a new drug, should other drug companies immediately be allowed to copy and sell the drug at a cheaper price? why or why not?
no. nobody would buy the original more expensive drug, the drug company that paid for developing the drug would not make that money back, and all incentive for researching and developing new drugs would be destroyed.
-
what is a generic equivalent drug?
a generic drug made by another company after the original company's (who developed the drug) patent expires.
-
can a generic equivalent have a trade name?
yes
-
are generic equivalents always just as good as the original?
no
-
are generic equivalents usually just as good as the original?
yes
-
what are drug labels and package inserts?
label or sheet of information put on or with individual bottles or vials of drugs, or with packages or batches of drugs. contain information only on approved uses, species, and doses.
-
list the major types of information found on drug labels and packages, or batches of drugs. contain information only on approved uses, species, and doses.
names of the drug, concentration, quantity, controlled substance status, manufacturer, lot number, expiration date, instructions, indications, contraindications, precautions, warnings, adverse reactions, side effects, overdosage information, dosages, dosage interval, storage.
-
define indications
approved uses - reasons to use the drug
-
define contraindications
conditions under which the drug should not be used
-
define precautions
reasons to use the drug carefully
-
define warnings
describes potentially fatal reactions or human health concerns. strongly worded.
-
define adverse reactions
unpredictable, severe, undesirable reactions. ex: allergic reaction
-
define side effects
normally occurring effect other than the intended therapeutic effect
-
define overdosage
clinical signs of OD, how to treat
-
define dosage interval
how often to give the drug. how many times a day or how many hours between doses
-
define storage
how to store to prevent deterioration of the drug. ex: refrigerate
-
what is the "withdrawal time" for a drug?
the period of time from the last does of the drug to the time that the animal can be slaughtered or its products used for human consumption.
-
what is the general types of animals do withdrawal times apply to?
food and dairy animals
-
what is the purpose of withdrawal times?
to prevent drug residues in human food products
-
what is the "extra-label" use of a drug?
when the drug is used for a purpose or in a species for which the drug has not been approved by the FDA
-
is "extra-label" use of drugs a common practice in veterinary medicine and why?
yes - it is too expensive and too cumbersome to approve every drug for every use in every species. we would find it difficult to practice veterinary medicine if we were limited to approved drugs only.
-
when is "extra-label" use of drugs considered "ok"?
when the drug is used in keeping with generally accedpted practice by veterinary peers, and the vet takes responsibility for the outcome of this use.
-
is extra-label use of drugs acceptable in food animals?
no
-
is infomation on extra-label use of a drug located on that drug's label or package insert?
no. must look in a reference book or formulary.
-
what is a prescription, or legend, drug?
a drug that has potential toxicity or must be administered in a way that requires trained personnel, must be used by or on the order of a licensed veterinarian.
-
what is an "over-the-counter" drug?
no prescription needed to buy, not much potential for toxicity, do not require special training to administer.
-
what are "controlled" or "schedule" drugs?
drug that have the potential for abuse or addiction by people
-
who controls these schedule drugs?
DEA
-
briefly, how are schedule drugs controlle?
users must be licensed by the DEA, need a DEA number and special form to order, must keep the most addictive drugs locked up, keep inventory, keep detailed log to account for the drugs.
-
list 4 characteristics of drug addiction
compulsion to use and obtain the drug by any means, tendency to increase dosage, dependence of drugs effects, detrimental effect on the individual and on society.
-
what special symbol is on the label of a controlled drug?
capital "C" enclosing a Roman numeral I-VI, depending on how the drug is classified
-
how must Schedule II drugs be ordered?
on a special order form available only to licensed veterinarians with DEA certification numbers.
-
what isneeded for ordering Schedule II - V drugs?
the veterinarian's DEA certification number.
-
when should the first controlled drug inventory be done in a veterinary hospital?
on the day that the licensed and certified veterinarian first begins to practice
-
how often must subsequent controlled drug inventories be done in a veterinary hospital?
within 2 years of the last inventory.
-
how much we store receipts for controlled drugs?
- CII - filed separately in chronological order.
- CIII - CV - filed together in chronological order.
-
how long must we keep controlled drug records - inventory, receipts, log book?
2 years
-
what is the purpose of keeping a controlled drug log book?
to stay out of trouble with federal and state authorities. if they find any significant discrepancies, we are legally liable. to be able to account for every bit of controlled drug.
-
what types of information are recorded in a controlled drug log book?
name, form, and strength of the controlled drug, date, time of day prescribed or used, patient's name and species, owner's name and address, how much drug was drawn up, used, and wasted, how many pills dispensed, how much remains in the bottle of vial, name (initials) of LVT dispensing and vet prescribing the drug, purpose.
-
why is it important to record any use of controlled drugs (including type and amount used) in the individual patient's record?
necessary in general for good medical and legal record-keeping, and necessary in particular in order to cross-reference between patient records and the drug log book - everything has to match up
-
how should a hospital's main stock of controlled drugs be stored?
in an unmovable, locked storage cabinet with the key accessible only to the licensed veterinarian and LVT - not to unlicensed personnel.
-
does anybody besides licensed veterinarians have legal access to controlled drugs in the veterinary hospital?
licensed veterinarians and licensed veterinary technicians can have access to controlled drugs - unlicensed personnel do not have legal access - should not know where the keys are.
-
in general, how do you dispose of expired controlled drugs?
label it "expired", keep it locked upw ith the other controlled drugs, call the DEA to get the current guidelines for disposal, and follow them.
-
are schedule I (CI) drugs available to veterinary practitioners?
no
-
which has the highest abuse potential - a schedule II drug or a schedule V drug?
schedule II
|
|