28 Questions
Which program is a proactive surveillance system designed to detect early signs of medication risk and safety problems?
Sentinel Initiative
What is the most serious classification of drug recalls?
Class I
What is the responsibility of the manufacturer during a drug recall?
Notifying sellers of drug recalls
What defines a Class II drug recall?
May cause temporary or medically reversible adverse health consequences
Which drug is exempt from the requirement of having child-resistant packaging?
Nitroglycerin
What term is used to describe the use of a drug for an indication not approved by the FDA and not listed in the drug's labeling?
Off-Label
Which term describes the failure to provide a patient package insert (PPI) when dispensing potentially dangerous drugs?
Misbranding
When must pharmacists include a patient package insert (PPI) with each container dispensed?
For both initially dispensed and refilled containers
MedGuides are mandated for drugs posing a 'serious and significant concern.' Which circumstances would require the FDA to determine that a MedGuide is necessary?
Serious risk or significant safety concern
What type of claims are NOT allowed on dietary supplements according to DSHEA?
Disease claims
What is the required statement that must appear on a dietary supplement label after a structure/function claim?
This statement has been evaluated by the FDA
Which of the following is NOT considered a component that can be found in a dietary supplement as defined by DSHEA?
Antibiotic
Why is it important to consult a doctor before using Aspirin products during the last 3 months of pregnancy?
To confirm the safety and necessity of using the product during pregnancy.
Failure to provide MedGuide or PPI to patient is considered ________.
misbranding
_______ and _______ are federally mandated (for certain drugs) and are considered labeling, therefore they require FDA approval before dissemination.
PPI's, MedGuides
_______ is the written information provided by the pharmacy for all drugs.
Useful written consumer medication information (CMI)
_______ does NOT replace the PPI or Medguide, it is NOT federally mandated, and does not require FDA approval before distribution.
Consumer medication information (CMI)
Tampering _______ means that the packaging has an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.
evident
Tamper- _______ regulations do not require tamper proof packaging - true for two-piece hard gelatin capsules.
evident
The FDA requires that the pharmaceutical product bar code includes _____.
Drugs NDC
______ refers to the date required on the manufacturer's containers.
Expiration
The Consumer Product Safety Commission (CPSC) administers the _____.
Poison Prevention Packaging Act (PPPA)
______ refers to the dating of drug products that are dispensed by pharmacists.
Beyond use date
A package will fail the child resistant test if more than ______% of the children test panel can open the package in 10 min.
20
Manufacturers may market _____ size of an OTC product for the elderly/handicapped in noncompliant packaging.
one
PPPA regulations state that pharmacists must normally dispense oral drugs in child resistant packaging EXCEPT when the physician or patient request _____.
noncompliant packaging
Improper interference with the product for the purpose of making objectionable or unauthorized changes refers to _____.
tampering
What does 'low sodium' mean? - contains 140 mg or less of Na per dosage unit _______ prohibited the FDA from regulating dietary supplements as drugs.
Dietary Supplement Health and Education Act of 1994 (DSHEA)
Test your knowledge on programs addressing medication safety, including MedWatch, REMS, Postmarket labeling, drug safety information websites, and the Sentinel Initiative. Explore examples of restricted distribution programs like Thalomid REMS and iPledge.
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