Module 2 Ch 4

Question 1

Combat Methamphetamine Epidemic Act of 2005

Answer 1

-Intended to limit sales of precursors to amphetamine and methamphetamine
EX: Ephedrine, Pseudoephedrine, Phenylpropanolamine
-Logbook of all transactions/ Photo ID required

Question 2

Daily Limit

Answer 2

3.6 grams

Question 3

Monthly In person limit

Answer 3

9 grams

Question 4

Monthly mail order limit

Answer 4

7.5 grams

Question 5

Risk Evaluation and Mitigation Strategy

Answer 5

-Administrered by FDA
-Goal is to mitigate a serious risk of a particular medication by informing, educating, and/or reinforcing actions to reduce the frequency and or severity of the event
-Specific to the medication

Question 6

Components of REMS

Answer 6

Medication Guide
Provider Communication
Elements to Assure Safe Use (ETASU)

Question 7

ETASU

Answer 7

-Training and or certification of prescribers
-Enrollment of patients in the REMS
-Special certification for dispersers
-Restriction of use to certain settings
-Documentation of a “safe use condition”
-Monitoring
-Creation and maintenance of a patient registry

Question 8

ETASU EX Prescriber

Answer 8

Enroll in REMS
Before Prescribing/ Initial Treatment
During Treatment

Question 9

ETASU EX Patient

Answer 9

Enroll in REMS
Two methods of contraception for a month prior to starting
Monthly comprehension questionnaire