Mod 1 Flashcards
Pharmacokinetics
the absorption, distribution, metabolism, and excretion of a drug in the living body
pharmacodynamics
study of the biochemical and physical effects of drugs and the mechanisms of drug actions in living organisms
pharmacotherapeutics
use of drugs (clinical indication) in the prevention and treatment of disease
Toxicology
the study of poisons, including the adverse effects of the drug on living organisms
pharmacognosy
deals with natural drugs- plants, animals or minerals and their products
- benefit of chemically developed drugs are they are free of the impurities found in natural substances
pharmacentic phase
where the drug becomes a solution so it can pass the biologic membrane so it can be used by the body
pharmacogenetics
how the effect of a drug action varies from a predicted drug response because of genetic factors or hereditary influence
controlled drugs
may lead to drug abuse or drug dependence, use is controlled by federal, state, or local laws
drug abuse
self directed use of drugs for nontherapeutic purposes
drug dependence
when a person can’t control drug intake. make physiologic or psychological or both
drug misuse
improper use of common drugs that can lead to GI bleeding, kidney or liver damage
recreational durgs
used for pleasant psychological of physical effects with no therapeutic aim
chemical name
describes the atomic and molecular structure
generic name
derived from chemical name but shorter
trade name
brand name, by the company marketing it, protected by copyright
prototype drug
a method to group drugs- a representative drug foe each class ex. morphine
1908
sulfa
1922
insulin
plant source examples
caffeine, nicotine, glycosides, oils
animals sources
body fluids or glands: hormones-insulin, oils- cod liver oil, enzymes- pancreatin, vaccines, epinephrine
mineral sources
maybe combined with other ingredients: coal tar with an acid yields salicylic acid, iron, iodine, zinc
laboratory
produce chemical source- PCN, oral contraceptives, humalin insulin
who monitors new drug development?
FDA- food and drug administration
IND ( Investigational new drug)
after reviewing drug studies and effectiveness of a new durg the FDA will approve an application for an IND
How many drug phases are there?
3
if the IND passes these phases then the company completes a NDA (new drug application)
what kind of drug is useful to treat a rare disease and is costly to develop?
orphan drugs
what did the pure food and drug act of 1906 do?
- required labeling for the presence of 11 identified dangerous or addictive ingredients
- prohibited false and misleading claims made on packaging (but no in other advertising materials)
what did the Harrison Narcotic act of 1914 do?
- attempted to curb drug addiction and dependence for the first time
- established “narcotic” as a legal term
what acts required safety studies before a new drug could be marketed and required labels to be accurate and complete?
food, drug and cosmetic act of 1938
what did the durham-humphrey amendment of 1952 do?
required legend drugs to be dispensable only by prescription
(distinguished between prescription and over the counter)
what did the Kefauver-harris amendment of 1962 do?
- required proof of safety and efficacy before the drug could be approved for use
- established drug testing methods
- required that all drugs introduced from 1936 to 1962 be rated for effective and ineffective drugs be withdrawn from the market
- gained strong support in the wake of the thalidomide tragedy in Europe
what act was designed to curb drug abuse and categorize drugs by their potential for abuse (created schedule of controlled substances)?
controlled substances act of 1970
what act streamlined the drug investigation process allowing for earlier release of new drugs to the public?
Drug regulation act of 1978
what are schedule I drugs?
drugs that have a high abuse potential, no currently accepted medical use in the US and pose unacceptable danger Ex. heroin, LSD, mescaline, methaqualone
what are schedule II drugs?
drugs have high abuse potential, but with currently acceptable therapeutic use. May lead to physical or psychological dependence or both. Written prescriptions are required, no telephone renewals.
what are schedule III drugs?
drugs that have a lower abuse potential than schedule I or II. Current acceptable therapeutic use in the US. Abuse may lead to moderate or low physical or psychological dependence or both. prescription required to be rewritten after 6 months or 5 refills
EX. non-narcotic derivatives of barbituric acid, paregoric, Tylenol with codeine
what are schedule IV drugs?
Drugs with less abuse potential than schedule III, acceptable therapeutic use in the US. written or oral prescription required, with refills limited to 5.
EX. barbital, phenobarbital, choral hydrate, valium, Ativan
what are schedule V drugs?
drugs with lower abuse potential and with currently acceptable therapeutic use in the US
EX. cough syrup that contains codine, lomotil, terpin hydrate (antitussive)
