Reading 7 Flashcards
Covers pregnancy categories, inspections, generic equivalency, the NDA process, and REMS.
What does pregnancy category A mean?
Adequate number of studies in pregnant women have been conduct and no demonstrated risk seen
What does pregnancy category B mean?
No adequate students in pregnant woman conducted, but animal studies show no demonstrated risk
What does pregnancy category C mean?
No adequate studies in pregnant woman, animal studies show risk or have not been conducted. Used if potential benefits outweigh the risks
What does pregnancy category D mean?
Evidence of risk. Used if potential benefits outweigh risks. Must contain a statement of fetal harm and patient should be aware
What does pregnancy category X mean?
Contraindicated for use during pregnancy. Risk outweighs any potential benefits
When would an FDA inspection at a pharmacy be warranted?
to verify that the pharmacy is not manufacturing/compounding appropriately
MUST BRING A NOTICE OF INSPECTION (NOI) AND SHOW THEIR CREDENTIALS
When would a DEA inspection be warranted?
any location where controlled substances are kept
Can the DEA review financial/sales/pricing data without a warrant or permission?
No
What must a DEA agent provide in order to enter a pharmacy for inspection?
NOI, credentials, and purpose of visit
True or false: the FDA must tell you whether or not the inspection is routine or complaint-based.
false
What is included in the statement of rights that accompanies a Notice of Inspection (NOI)?
- right to require the DEA to get an AIW
- right to refuse inspection; will trigger AIW
- anything incriminating can be used against you
- you’ll get a copy of the notice
- you can withdraw consent at any time; will trigger AIW
In which 3 scenarios are warrants not required?
- owners or PIC consents
- imminent danger to public health/safety
- emergencies
Which warrant has the higher threshold for probable cause?
Search warrant
Which warrant can be served at any time of day?
Search warrant
When must an Administrative Inspection Warrant (AIW) be served?
regular business hours
Which pharmacy inspection can you NOT refuse, even if there isn’t a warrant?
Board of Pharmacy
What is the source for generic equivalency ratings?
Orange Book
What is the source for interchangeable biological products?
Purple Book
What source lists whether drug products are bioequivalent to the Reference Listed Drug (RLD)?
Orange Book
True or false: there can be more than one RLD for a drug product.
true
Drug products must be both ____________ and ___________ to be interchangeable or substitutable.
therapeutic equivalents; pharmaceutical equivalents
In the Orange Book ratings, what does the first letter indicate?
bioequivalence information
In the Orange Book ratings, what does the second letter indicate?
additional bioequivalence information or dosage form information
What happens during Phase 1 of an IND clinical trial?
first introduction into human subjects; healthy volunteers and designed to understand the profile of the drug; involve less than 100 patients
What happens during Phase 2 of an IND clinical trial?
first introduction to patients with the disease; evaluate the effectiveness of the drug; involve less than 1000 patients
What happens during Phase 3 of an IND clinical trial?
introduction into a large number of patients with the disease; continue to expand safety and efficacy data; involve several thousand patients
Generally, how long does the FDA have to respond with a decision after the NDA has been submitted?
180 days (although they often need more time based on the information shared)
When is an NDA form completed and submitted?
after all trial phases are complete; details all the information obtained during the IND process
ANDAs are used for the approval of what drugs?
generics
True or false: in an ANDA, a manufacturer must redo all trial phases to demonstrate bioequivalence.
false
True or false: REMS are designed to stop all issues with drugs.
false
What are the 4 parts of REMS?
- patient-friendly labeling
- communication plans
- Elements to Assure Safe Use (ETASU)
- implementation system
What is ETASU?
required activities or clinical interventions done prior to prescribing, dispensing or receiving a product (iPLEDGE system with isotretinoin)
