1906 Federal Food and Drug Act - ✔✔ outlawed the sale of adulterated or misbranded products
1914 Harrison Narcotic Act - ✔✔ put taxes on
... [Show More] anyone that traded opium (bases of cocaine)
1970 Controlled Substance Act*** - ✔✔ put medications in 5 classes with different regulations; consolidates many laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, as well as chemicals used in production of controlled substances.
1983 Orphan Drug Act - ✔✔ pushed for research into medications to treat rare diseases
1991 Accelerated Drug Review - ✔✔ Pushed drugs through FDA process a little faster
1996 Health Insurance Portability and Accountability Act (privacy act) - ✔✔ keep insurance down
2003 Medicare Prescription Drug Improvement and Modernization Act - ✔✔ provide information to blind and visually impaired
2010 Affordable care act - ✔✔ make health care more accessible to all citizens
therapeutics - ✔✔ refers to the use of drugs and the method of their administration in the treatment of diseases
pharmacology - ✔✔ the broadest term for the study or science of drugs
traditional drugs - ✔✔ drugs made from chemicals
biologic drugs - ✔✔ drugs made of living matter
alternative therapies - ✔✔ any drug used to treat illness with out a scientific background (herbal medications)
makes the rules - ✔✔ what does the FDA do in the drug approval process?
schedule one - ✔✔ High potent- high abuse potential and dependency-heroin ecstasy- no written prescription
schedule two - ✔✔ high abuse potential-no refills-ridilin, cocaine
schedule three - ✔✔ moderate to low abuse potential- anabolism steroids and testosterone (up to 5 refills)
schedule four - ✔✔ low abuse-Xanax, adavan (up to five refills)
schedule five - ✔✔ lowest abuse- larica, Robitussin (up to five refills)
phase one of approval - ✔✔ 20-30 people, healthy people, does it kill them
phase two of approval - ✔✔ few hundred people with condition
phase three of approval - ✔✔ thousands of people, how does it interact with other meds, doses
phase four of approval - ✔✔ mass release
pre-clinical investigation - ✔✔ someone creates a chemical structure they think will work and approach FDA
helps impaired nurses in the recovery process, ensures public safety, and helps nurses to identify when someone is impaired and what steps to follow - ✔✔ what is the purpose of ISNAP?
controlled substance - ✔✔ a drug or chemical substance whose possession and use are controlled by law
they combat drug smuggling and use in the US - ✔✔ what is the role of the DEA (drug enforcement agency) in controlling drug abuse and misuse?
category A - ✔✔ no risk to fetus
category B - ✔✔ no risk to animal fetus
category C - ✔✔ adverse effects to animal fetus
category D - ✔✔ possible risk to human fetus reported
category X - ✔✔ fetal abnormalities reported
Pharmacokinetics - ✔✔ The study of what happens to a drug from the time it is put into the body until the parent drug and all metabolites have left the body.
Pharmacodynamics - ✔✔ The study of the biochemical and physiologic interactions of drugs at their sites of activity.
Pharmacotherapeutics - ✔✔ The treatment of pathological conditions through the use of drugs
healthy males age18-40 - ✔✔ who are tests usually done on?
children have more water and fat content, immature organs, can become toxic easier, store meds longer - ✔✔ why don't we test drugs on children?
increased blood volume, metabolism slows - ✔✔ what are some changes that occur in pregnancy that affect the absorption, distribution, metabolism, and excretion of drugs?
body fat and water decrease, but organs are over ripe, so thy build up the drug in their blood stream, can become toxic - ✔✔ why dont we test drugs on the elderly?
1970 - ✔✔ In what year did substances of abuse get divided into schedules of potential? [Show Less]