Organizations Flashcards
(10 cards)
what is it called when insurance regulate medication costs and try a less expensive medication before their insurance company will cover a more expensive one
Step Therapy
What is the agency that ensures the safety, effectiveness, and quality of medications. That ensures the safety, effectiveness, and quality of medications
FDA
Adverse event reports, MEDICATION ERROR reports and product quality complaints resulting in adverse events that were submitted to FDA
FDA Adverse Event Reporting System (FAERS)
a risk evaluation and mitigation strategy (REMS) program required by the FDA for isotretinoin
iPLEDGE
a voluntary reporting program operated by the U.S. Food and Drug Administration (FDA) for REPORTING serious adverse events, product quality problems, and therapeutic failures related to various medical products
MedWatch
What is the national public health agency of the United States that aims to protect public health and safety in the US and worldwide by preventing, detecting, and responding to DISEASE AND INFECTION threats.
CDC
What is a U.S. federal law enforcement agency under the Department of Justice tasked with combating illicit/ CONTROLLED drug trafficking and distribution within the United States
DEA
What is an American 501 organization focusing on the prevention of medication ERRORS and promoting safe medication practices.
ISMP- Institute for Safe Medication Practices
What is a program required by the U.S. Food and Drug Administration (FDA) to ensure the benefits of certain prescription drugs outweigh their risks
REMS
What contains data which is submitted to FDA for the review and potential approval of a generic drug product.
Abbreviated New Drug Application (ANDA)