exam 1

Question 1

Durham-Humphry Act (1951)

Answer 1

3 criteria of OTCs
Non-habit forming
Safe when used as directed
*appropriate for self treatment; lack of side effects that need medical monitoring
Not declared to be Rx

Question 2

Kefauver-Harris Drug Amendments (1962)

Answer 2

requires that efficacy of Rx drugs proved PRIOR to marking; drugs must be EFFICACIOUS; didn’t apply to OTC

Question 3

FDA category I

Answer 3

Recognized as Safe and Effective

Generally Recognized as Safe and Effective

Question 4

FDA category II

Answer 4

Not recognized as Safe and Effective

Question 5

FDA category III

Answer 5

Insufficient data to classify into categories 2 or 2

unacceptable indication; undergoing review but can be included in market

Question 6

Assessment

Answer 6

Questions
Patient focused- who ( age, gender, disease states, etc.)
Problem focused- where, when ,what how
Determine risk level

Question 7

Triage

Answer 7

decision making

recommend non-drug therapy, OTC if appropriate, or refer

Question 8

Counseling/Patient Ed

Answer 8

proper use of recommended therapy

Question 9

FDA Phase I of safety review

Answer 9

Classification of ~700 DI

Question 10

FDA Phase II of safety review

Answer 10

Development and publishing of tentative final monographs for category 1 and category 2 ingredients

Question 11

FDA Phase III of safety review

Answer 11

Final monographs