Lecture 9 - OTC Flashcards
1
Q
OTC analgesics were responsible for ____% of adverse drug events
A
15.4
2
Q
What are the requirements for all OTC drug products?
A
Standards for safety and efficacy
Good manufacturing practices (inspections)
Labeling under 21 CRF 201.66
Consumers must be able to... Self diagnose Self treat Self manage Which can be assessed through .... Label comprehension studies Actual use studies
3
Q
OTC drugs generally have these characteristics:
A
Their benefits outweigh their risks
The potential for miscue and abuse is low
Consume can use them for self-dx conditions
They can be adequately labeled
Health practitioners are not needed for the safe and effective use of the product
