Under REMS authority, the FDA can require what?
a variety of procedures ranging
from Medication Guides to limiting the drug to specified settings for
dispensing
What does the The FDAAA requires pharmacies to provide patients with?
the MedWatch
number and a statement about reporting side effects.
NOT the same as Med guide
True or false: Manufacturer must establish and maintain a post-market records and reports
True or false: Serious adverse drug reactions must be submitted to the FDA and any new
safety or efficacy information
- Both True
What has the FDAAA empowered the FDA to require manurfacturers to do when adverse event reporting or active surveillance is inadequate?
Upon approval of the NDA, what can manufacturers do?
- FDA to require manufacturers to conduct phase** IV clinical trials **
- may legally distribute the drug into Interstate commerce
Post-Marketing Surveillance: Phase IV Clinical Trials
When is it conducted? Why? Can the FDA require it as part of the approval process?
- after the drug has been marketed
- To gather info on the drug’s effect in various populations & info regarding side effects associated with long-term use
- yes
What is Med Watch? What is it maintained by?
- Voluntary reporting system that allows healthcare professionals to report serious adverse events (serious drug
side effects, product use errors, product quality
problems, and therapeutic failures for:
* Prescription or over-the-counter medicines
* Biologics
* Medical devices
* Special nutritional products
* Cosmetics
* Foods - maintained by the FDA
True or False: The FDAAA requires
prescribers to provide patients with the
MedWatch number and a statement about
reporting adverse side effects.
False - pharmacists
What are Patient Package Inserts (PPI)? Who develops it? Who approves it? Is it required? When is it required?
- FDA-approved prescription drug labeling
- developed by the manufacturer, approved by the FDA
- Yes, required to be dispensed with specific products or classes of products
Are other PPIs required?
no, they’re voluntarily submitted by the manufacturer and approved by the FDA, but their distribution is not mandated
What are medication guides? What does it contain? Who develops it? Who approves it? Is it required?
- paper handouts that come with many prescription medicines
- contain FDA-approved info that can help patients avoid serious adverse events.
- developed by the manufacturer
- approved by the FDA
- May be required to be given
to consumers each time the medication is dispensed (REMS) or if material changes
What is REMS? What made it? Why was it made? Is it required? What requirement did it make?
- intended to manage known or potential serious risks of the product.
- FDAAA granted the FDA authority to
require a drug product sponsor to establish
special procedures directed at patient safety. - FDA can require REMS for pending NDA as well approved drugs.
- Required Medication Guides can be part of the REMS Program.
Prescription Drug Labeling - Info for the Patient
What are Medication Guides required with?
- certain prescribed drugs and biological
products when the FDA determines that:
* necessary to prevent serious adverse effects
* needed for patient decision-making
* patient adherence to directions for the use of a product are essential to its effectiveness
Poison Prevention and Packaging Act (PPPA)
What does the Poison Prevention and Packaging require?
- “special packaging” of household products
and drugs to protect children from serious
injury or illness
Who are legally required to dispense Med Guides with
each fill (initial and refill) for applicable drugs?
Pharmacists
Poison Prevention and Packaging Act (PPPA)
What is the reasoning behind child-resistant packaging?
- the nature of this packaging would avert children of the age of 5 and younger from easy access and provide a protected container
Poison Prevention and Packaging Act (PPPA)
True or false: Manufacturers can market 1 size of an OTC product for the elderly or handicapped in non-compliant containers, provided that the package states, “This Package for Households Without Young Children.“
True
Pharmacist Guidelines and Responsibilities under the PPPA
Which drugs must be in in child-resistant containers unless an exemption applies?
Oral medication
Who can ONLY provide a “blanket” waiver for child-resistant packaging? How?
Patients
Pharmacists should obtain patient waiver for child-resistant packaging in writing from the
patient or their agent
Are Institutionalized patients required to receive child-resistant containers
No
Can providers provide a “blanket” waiver for child-resistant packaging for patients?
No
only patients themselves can requets it in writing
