Questions and Answers
What is the primary purpose of the notification requirement for pharmacies in the case of a Class I recall of a prescription drug?
Under which circumstance would a pharmacy be required to notify patients about a recalled prescription drug?
What is the maximum timeframe allowed for a pharmacy to notify patients after receiving notice of a Class I recall?
How does the notification requirement differ for pharmacies that are part of a chain?
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What is the definition of "class I recall" as outlined in the text?
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Study Notes
Class I Recall
- A class I recall occurs when the US FDA determines that a product has a reasonable probability of causing serious adverse health consequences or death.
Prescription Drug Recall Notification
- In the event of a class I recall of a prescription drug, pharmacies must make a reasonable attempt to notify patients who: • Have been prescribed the recalled drug • Are currently taking the recalled drug • Received the drug from the pharmacy
- Notification must be made within three days of the pharmacy being notified of the recall by: • The US FDA • A manufacturer • A wholesaler • Other notice of the recall
- Notification can be provided by: • An individual pharmacy • A central office (in the case of a pharmacy chain)
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Description
This quiz covers the protocol for pharmacies to follow in the event of a Class I recall of a prescription drug, including notification procedures for affected patients.
