Medication Development, Regulation, and Resources Flashcards
acts as the coordinating authority on international public health, providing technical assistance in the drug field and promoting research on drug.
World Health Organization
1970, established classifications, known as schedules, of medications that had potential for abuse.
Controlled Substance Act
It set standards for handling controlled substances and has the legal authority to enforce those standards.
DEA
Assures the safety and health of American workers by setting and enforcing standards. ex. from sharps and sticks.
OSHA
Evaluates and accredits approximately 16,000 health care organizations and programs in the US.
The Joint Commission/JCAHO
the study of genetic factors in predicting a medication’s action and how it could vary from its intended response.
Pharmacogenetics
assigns and official name to the new medication; this is usually the generic name.
USP-NF
PDR
physicians desk reference
USP
United States Pharmacopeia
how much liquid in the bottle (ml)
total volume
PHARMACIES HAVE TO REGISTER WITH DEA TO BE ABLE TO DISPENSE
controlled substances
US FDA pregnancy categories?
A: No risk to fetus per studies
B: Little or no risk assumed
C: Risk vs benefit of drug must be determined
D: Risk to human fetus proved.
X: Risk outweighs benefit, drug should be avoided
Medication References
Drug Facts and Comparisons
Hospital Pharmacist
Databases Internet
Use internet for resources
Phase I Clinical Pharmacology
determine toxicity levels.
Phase II
Clinical investigations establish effectiveness; determine optimum dosage and dose range.
OTC
Over the counter
During testing, drug company assigns
a generic name
Drugs with high abuse potential and severe physical and psychologic dependence. No medicinal use (Heroin, LSD, marijuana)
C-I drugs
High potential for drug abuse. Accepted medical use, but can lead to physical and psychological dependency. (opium, cocaine, morphine)
C-II drugs
Potential for drug abuse less than in previous categories. Medically accepted for use. High psychologic dependence, low physical dependence (anabolic steroids, products with low codeine)
C-III drugs
Potential for dependency. Medically accepted for use. Limited psychologic and physical dependence
C-IV drugs
provides accurate information on almost all prescription medications marketed in the US
AHFS
What does red writing on the label of a local anesthesia indicate?
presence of epinephrine
FDA Pregnancy Categories
Categories A & B are considered safe for use during pregnancy
