Medication Development, Regulation, and Resources

Question 1

acts as the coordinating authority on international public health, providing technical assistance in the drug field and promoting research on drug.

Answer 1

World Health Organization

Question 2

1970, established classifications, known as schedules, of medications that had potential for abuse.

Answer 2

Controlled Substance Act

Question 3

It set standards for handling controlled substances and has the legal authority to enforce those standards.

Answer 3

DEA

Question 4

Assures the safety and health of American workers by setting and enforcing standards. ex. from sharps and sticks.

Answer 4

OSHA

Question 5

Evaluates and accredits approximately 16,000 health care organizations and programs in the US.

Answer 5

The Joint Commission/JCAHO

Question 6

the study of genetic factors in predicting a medication’s action and how it could vary from its intended response.

Answer 6

Pharmacogenetics

Question 7

assigns and official name to the new medication; this is usually the generic name.

Answer 7

USP-NF

Question 8

PDR

Answer 8

physicians desk reference

Question 9

USP

Answer 9

United States Pharmacopeia

Question 10

how much liquid in the bottle (ml)

Answer 10

total volume

Question 11

PHARMACIES HAVE TO REGISTER WITH DEA TO BE ABLE TO DISPENSE

Answer 11

controlled substances

Question 12

US FDA pregnancy categories?

Answer 12

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

Question 13

Medication References

Answer 13

Drug Facts and Comparisons
Hospital Pharmacist
Databases Internet
Use internet for resources

Question 14

Phase I Clinical Pharmacology

Answer 14

determine toxicity levels.

Question 15

Phase II

Answer 15

Clinical investigations establish effectiveness; determine optimum dosage and dose range.

Question 16

OTC

Answer 16

Over the counter

Question 17

During testing, drug company assigns

Answer 17

a generic name

Question 18

Drugs with high abuse potential and severe physical and psychologic dependence. No medicinal use (Heroin, LSD, marijuana)

Answer 18

C-I drugs

Question 19

High potential for drug abuse. Accepted medical use, but can lead to physical and psychological dependency. (opium, cocaine, morphine)

Answer 19

C-II drugs

Question 20

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)

Answer 20

C-III drugs

Question 21

Potential for dependency. Medically accepted for use. Limited psychologic and physical dependence

Answer 21

C-IV drugs

Question 22

provides accurate information on almost all prescription medications marketed in the US

Answer 22

AHFS

Question 23

What does red writing on the label of a local anesthesia indicate?

Answer 23

presence of epinephrine

Question 24

FDA Pregnancy Categories

Answer 24

Categories A & B are considered safe for use during pregnancy

Question 25

Was passed in 1906, it set standards for quality and required proper labeling of medications

Answer 25

Pure food and drug act

Question 26

the general study of all genes and genetic technology that determine medication behavior.

Answer 26

Phamacogenomics