Module 2 ch 5

Question 1

Recall

Answer 1

The removal of a drug from the market by the drug manufacturer
-May be under own volition or at the direction of the FDA

Question 2

Reasons for recall

Answer 2

-Mislabeling
-Inconsistencies in potency
-Contamination
-Failure to adhere to good manufacturing practices
-New safety concerns
-Other issues that pose a threat

Question 3

FDA’s role in a recall

Answer 3

Oversee: the company’s recall strategy
Assess: the adequacy of the recall
Monitor: the communication from the manufacturer and the depth of the recall process
Classify: the recall into one of three categories

Question 4

Class 1

Answer 4

A dangerous or defective product that could cause serious health problems or death

Question 5

Class 2

Answer 5

A product that may temporarily cause health problems

Question 6

Class 3

Answer 6

A product that is unlikely to cause any adverse health effects

Question 7

Technicians role in recall

Answer 7

-Monitor: FDA alerts
-Remove: recalled stock and take action as directed in the recall
-Notify: patients who received recalled medication

Question 8

HIPPA

Answer 8

-Applies to most health entities regarding patient medical info (Mental, physical health, payment, and provision of health)

Question 9

PHI

Answer 9

Noted health info is considered Protected Health Information

Question 10

Identifiers include

Answer 10

Name, address, birth date and social security

Question 11

HIPPA- Notice and Rights

Answer 11

-Privacy Practices Notice
-Access
-Amendment
-Disclosure Accounting
-Restriction Request
-Confidential Communications Requirements