++
Chapter 15: Drug Shortages and Counterfeit Drugs
++
++
++
The trend in drug shortages for 2016 is one of:
++
++
++
a. Decreasing new shortages and increasing active shortages
++
++
b. Increasing new shortages but decreasing active shortages
++
++
c. Slight increase in new shortages and decreasing active shortages
++
++
d. Decreasing new shortages and a gradual decrease in active shortages
+
++
d. Decreasing new shortages and a gradual decrease in active shortages
++
++
++
Most shortages have occurred due to:
++
++
++
a. Raw material shortages
++
++
++
++
c. Manufacturing or quality problems
++
++
+
++
c. Manufacturing or quality problems
++
++
++
Package inserts must include which of the following items:
++
++
++
a. Name of the company that manufactured the drug
++
++
b. Location of the factory
++
++
c. Country of origin for the active pharmaceutical ingredient (API)
++
++
+
++
++
++
++
FDA can help prevent drug shortages by:
++
++
++
a. Prioritizing approvals of new products
++
++
b. Forcing companies to increase production
++
++
c. Forcing companies to continue to produce a drug
++
++
d. Decreasing drug prices
+
++
a. Prioritizing approvals of new products
++
++
++
FDA can help alleviate an ongoing drug shortage by:
++
++
++
a. Requiring companies to manufacture additional product
++
++
b. Fine companies that don’t provide advanced notice of a shortage
++
++
c. Allowing companies to import products that meet FDA criteria
++
++
d. Override patents and approve new formulations
+
++
c. Allowing companies to import products that meet FDA criteria
++
++
++
The FDASIA bill was signed in July 2012 and gave FDA what new authority with regard to drug shortages?
++
++
++
a. Allows FDA to make their own products to prevent shortages
++
++
b. Allows FDA to require manufacturers to notify them in advance ...