ch. 3 Drug regulation, development, names, information

Question 1

Drug regulation

Answer 1

-drugs are regulated by Food and Drug administration (FDA)

1906- first american law regulating drugs

10 laws have been enacted

Question 2

Hazardous Drug Exposure:

Answer 2

• National Institute for Occupational Safety and Health (NIOSH)
• est. 1970, ID hazardous drugs, publishes safe handling practices
  —carcinogen
  —teratogen
  —reproductive toxicity
  —organ toxicity at low doses
  —genotoxicity
  —new drugs similar to known toxic drugs

Question 3

controlled substances

Answer 3

controlled substances act:

• created schedules I-V of controlled drugs
• schedule I has no patient use in U.S (heroin, LSD)
• Schedule II-V, used in U.S; potential for abuse
  —control is looser the higher the schedule

*lower the number- the higher the abuse potential and the tighter the control

Question 4

Controlled Substances

Answer 4

Schedule II
- cocaine, methamphetamine, methadone, hydromorphone, meperidine, oxycodone, adderall, ritalin, fentanyl

Schedule III
- codeine, ketamine, anabolic steroid, testosterone

Schedule IV
- xanax, soma, darvocet, valium, ativan, ambien, tramadol

Schedule V
- lomotil, lyrica, gabapentin

Question 5

Drug Development:

Answer 5

Randomized controlled trial(RCT): most reliable way to assess drug therapies, used to evaluate all new drugs, minimize personal bias in results- controls, randomization, binding

Stages of new drug development
— preclinical testing: takes 1-5 yrs. (animals)
— clinical testing (humans) 2-10 yr; 4 phases using healthy subjects progressing to actual patients tests include metabolism, therapeutic usefulness, dose range, side effects
Phase IV: postmarket surveillance

Limitations of testing procedure:
- limited info in women and children
- not all adverse effects are caught
- FDA mandates participation of women now; most participation of children in postmarketing surveillance

Question 6

Drug Names: Chemical

Answer 6

chemical nomenclature

not usually used in clinical setting

ex. N-acetyl-parapaminophenol

Question 6

Drug name: Generic

Answer 6

• each drug has one generic name
• naming method preferred for general use
• final syllable/suffix often indications drug class

ex. acetaminophen

Question 6

Drug names: Brand

Answer 6

• AKA trade name
• assigned by drug company
• easier to remember
• must be FDA approved

ex. Tylenol

problems with drug names is they can be hard to remember, pronounce

Question 6

OTC drugs

Answer 6

• can be purchased without prescription
• accounts for 60% of all doses of medication administration
• 40% of Americans use OTC at least every other day
• OTC status is determined by FDA- new labeling requirements 2006
• average household has 24 OTC drugs in cabinet