Pace University
Pharmacokinetics - study of what the body does to the drug.
Drug nomenclature:
a. Chemical name - identifies chemical structure.
b. Generic (official name) - assigned by the U.S. Adopted Name Council.
c. Trade (proprietary) name
Sources of Drug Information:
United States Pharmacopeia (USP) and National Formulary (NF) - describe well accepted therapeutic agents as to source, chemistry, physical properties, tests for identity, standards of purity, storage characteristics, therapeutic dose range in humans and general uses.
a. Legally enforceable standards of drug identity, purity and activity.
b. authoritative and unbiased
c. 3-volume abbreviated version available - USP DI (Dispensing Informaiton):
1. Drug info for the Health Care Professional.
2. Advice for the Patient.
3. Approved Drug products and legal requirements.
d. Physician's Desk Reference (PDR)
1. only contains info supplied by the pharmaceutical companies.
2. no comparisons among drugs
3. only lists FDS-approved indications.
Legal:
Food and Drug Administration (FDA)
Approves or rejects applicaitons from drug companies to market new drugs. Old drugs which fail to meet purity, safety or efficacy standards may be removed from the market.
1906 - Food, Drug and Cosmetic Act
1938 - required accurate labeling of medicinals
1951- allowed FDS to set up over-the-counter (OTC) vs prescription drugs.
1958- zero tolerance for drug or food additive that has been shown to be carcinogenic in man or animal.
1962- manufacturer must demonstrate efficacy as well as safety of new drugs;
- review of drugs introduced between 1938 and 1962;
-set guidelines for human and animal testing.
1972- review of efficacy and safety of OTC drugs.
Drug Enforcement Administration (DEA)
Purpose is to establish a balance between legitimate medical needs while minimizing the availability of the drug for abuse.
1914 Harrison Narcotic Act - regulaiton of opium derivatives, cocaine, and marijuana.
1970 Comprehensive Drug Abuse, Prevention and Control Act (Controlled Substances Act0- regulates the manufacture, distribution, dispensing, use and possession of all CNS drugs with abuse potential with the exception of alcohol and tobacco.
a. enforced by the DEA of the U.S. Dept. of Justice
b. individual states may have laws that are stricter than those of the DEA.
c. all controlled substances are placed in one of five "schedules" depending on their abuse potential and their clinical usefulness.
d. any preparation contianing a controlled substance must be so labeled.
e. all licenses (a DEA license is needed to manufacture, prescribe or dispense a controlled substance) must keep these drugs under lock and key and must keep accurate records and inventories.
Schedule
Abuse potential
examples
comments
handling
C-1
highest
heroin, LSD
no accepted medical use
research only.
CII
high
morphine, meperidine,amphetamine, secobarbital, PCP
may produce physical or psychological dependence,accepted medical uses.
prescriber's signature required, no refills
C-III
moderate
codeine mixtures, stimulants and sedatives
may produce moderate-low physical or psychological dependence, accepted medical uses
prescriptions may be phoned in; no more than 5 refills in 6 months, container with warning label.
C-IV
less
benzodiazepines, pentazocine, phenobarbital
none
same as C-III
C-V
least
some codeine containing cough syrups, diphenoxylate
none
can be bought OTC in some states.