Lesson 1 Flashcards
US Pharmacopeia: NF
National Formulary
-recognized as official authoritative reference standards for FDA approved drugs.
-these drugs have USP behind their official name.
US pHarmacopeia: DI
Drug Information
3 volume set that is available in most hospitals and pharmacies
- supplies monthly supplements
- provides pharmacology, precautions, side effects, adverse effects, patient consultation, general dosing info, and dosage forms
Volume 1A & 1B of USP-DI
drug information for the healthcare provider
Volume 2 of USP-DI
drug information for the patient
1935: Food, Drug, and Cosmetic Act
empowered the FDA to ensure drug safety by monitoring and regulating the manufacture and marketing of drugs
1970: Controlled Substance Act
designed to remedy the escalating problem of drug abuse
4 provisions of CSA
(1) Promotion of drug education and research into the prevention and treatment of drug dependence
(2) strengthening of enforcement authority
(3) establishment of treatment and rehabilitation facilities
(4) designation of schedules, or categories, for controlled substances according to abuse liability
Schedule 1 controlled substance
highest abuse potential, no medical use
-Heroin, hallucinogens, LSD
Schedule 2 controlled substance
high potential for abuse/strong physical and psych dependency
- accepted medical use
- Demerol, Morphine, hydrocodone, dilaudid, methadone, oxycodone, codeine, amp, phenobarbital
Schedule 3 controlled substance
potential for abuse/may cause dependency
-codeine preparations, non-narcotics
Schedule 4
may cause dependence
-valium, benzodiazepines
Schedule 5
very limited potential for dependence
-opioid-controlled substances for diarrhea and cough
Nurse Practice Act
laws developed by each state that define the scope of practice
-includes legal role/responsibility in medication administration
The State Board of Nursing
regulatory board that oversees the laws of NPA
ANA Code of Ethics
guide for carrying out nursing responsibilities in a manner consistent with quality in nursing care and the ethical obligations of the profession
What the nurse “should” do
ethical considerations
How does the nurse protect the patient in regards to ethics
-safeguards the patient’s rights, safety, and dignity
Primary obligation of the nurse
the patient
Patient has the right to….
know (informed consent) and refuse
Drug approval process
- drug discovery + development (2-10 yrs)
- preclinical research + development (3-6 yrs)
- clinical trial (6-7 yrs)
- FDA reviews new drug application (NDA) (1-2 yrs)
- Manufacturing
generic
official name
common
univerisal
trade/brand
- chosen by the drug company
- Advertised name
- Registered trademark
chemical
describes the drug’s chemical structure
FDA
- approves new drugs
- steady since 2000s
- 23 avg approvals per year
