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Pharm - Introduction to Pharmacology
Terms in this set (17)
"dry" in latin
what are Narrow therapeutic Index (NTI)?
are drugs where small differences in dose or blood concentration may lead to serious therapeutic failures and/or adverse drug reactions that are life-threatening or result in persistent or significant disability or incapacity
What does it mean when a drug is 'negative formulary'?
you can't substitute it
What are the active drug sources (5)?
1. plants (active compound... included: alkaloids, glycosides, oils, gum, resins)
3. natural salts, minerals, coal tar
5. recombinant DNA
What are the inactive drug constituents? (3)
1. fillers (i.e. sugar)
2. vehicle (i.e. alcohol or oil)
3. flavorings/dyes (i.e. raspberry/strawberry)
Pure Food and Drug Act of 1906
- protect public from mislabeled drugs
- established standards: USPNF
- empowered federal government to enforce
Sherley Amendment (1912)
Prohibited labeling medicines with false therapeutic claims intended to defraud consumers
FDA: Created in 1931
- regulation and oversight of pharmaceuticals, pharmaceutical industry
- part of the US Department of Health and Human Services (HHS)
- counterpart in HHS include Center for Control and Prevention (CDC), National Institute of Health (NIH), and Healthcare Financing Administration (HCFA)
Updated Federal Food, Drug and Cosmetic Act 1938
- All drugs must be properly tested
- The FDA to monitor and regulate
- Label must include - content, name of drug, substances, warnings, manufacture, direction, statement must not be false of misleading
1952 Durham-Humphrey Amendment
prescription (legend) vs non-prescription (OTC)
- dispensing certain drugs (legend drugs -- hypnotic, narcotics, habit forming drugs) must be written/verbal by a health care provider
Kefauver Harrison Amendment 1962
1. FDA empowered to supervise drug production
2. Official name by FDA
3. National research council (drug testers!!
3 levels of the National research council
- ineffective (no evidence)
- possibly effective (might, probably effective, some)
- effective (substantial evidence)
Schedule I - High abuse potential, may lead to severe dependence (No accepted medical use). Examples: Heroin, Marijuana, Peyote)
Schedule II (mainly for pain) - High abuse potential, may lead to severe dependence. Examples: morphine, codeine, methadone, amphetamine
Schedule III - Abuse potential less than schedule I & II, may lead to moderate dependence. Examples: Drugs that are combinations of opiate and non-narcotic drugs like Tylenol with codeine.
Schedule IV - Moderate abuse potential, may lead to limited dependence. Example: valium, ativan, phenobarbital
Schedule V - Small abuse potential, may lead to limited dependence. Examples: cough medications with codeine, certain antidiarrheals.
Who are the Regulators: protectors and prosecutors ?
FDA (HHS) - new drugs and regulations
DEA (justice department) - controlled substances
State Board of Pharmacy - state laws
Joint Commision - accreditation of healthcare facilities
FDA Pregnancy Categories (risk of fetal injury)
Category A: no risk in controlled human studies
Category B: no risk in other studies. In animal studies = no risk, but no studies in pregnant women
Category C: risk not ruled out. In animal studies = adverse effects, but no human studies; benefits may outweigh the risk
Category D: positive evidence of fetal risk, but benefit may outweigh risks
Category X: contraindicated in pregnancy. studies demonstrated fetal abnormalities, risk outweigh potential benefits
what are the properties of an ideal drug?
effectiveness, safety, selectivity
what are the 5 drug standards?
purity, potency, bioavailability, efficacy, safety/toxicity
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