Drug Safety and Drug Recalls Flashcards
When must a med guide be dispensed
every fill for a high-risk medication
What must be dispensed for ALL medications the first time it is being dispensed
Consumer medication information
Medwatch allows healthcare professionals to voluntarily report:
Any serious adverse events
Potential and actual product use errors
Product quality errors
Class I recall
Reasonable probability use will cause serious adverse health consequences or death
Class II recall
Use may cause temporary or medically reversible adverse health consequences. Probability of serious adverse health consequences is remote
Class III recall
Use is not likely to cause adverse health consequences
Who may initiate a recall
FDA or Manufacturer