As you learned in other sections of this book and the discussion of the Durham-Humphrey Amendment, prescription drug labeling by manufacturers is directed at the healthcare professional, not the patient. There are, however, two types of labeling mandated by federal law that manufacturers must supply for the patient - Patient Package Inserts (PPIs) and Medication Guides (MedGuides).
Useful Written Patient Information and Medication Guides
Drug Information Website for Pharmacists: Drug Info Rounds
Drug Information Website for Consumers and Health Professionals: Drugs@FDA
Community pharmacies and, in many situations, institutional pharmacies must dispense PPIs to patients for oral contraceptives, estrogen-containing drugs, and DES drugs.
CMI is written information other than a PPI or MedGuide that a pharmacy distributes to a patient and is not reviewed by or regulated by the FDA.
The FDA requires that manufacturers produce and that pharmacies dispense MedGuides for drugs that pose a "serious and significant concern."
Subject to certain exceptions, a MedGuide is not required when the drug is dispensed to a healthcare professional for administration to a patient in an inpatient setting or in an outpatient setting such as in a clinic or dialysis or infusion center.
The FDA may require that a MedGuide be all of or part of a REMS, or simply be required as labeling.
The FDA maintains websites where healthcare professionals and patients can access medication-related information.
A community pharmacy dispenses prescriptions to a patient for conjugated estrogen, warfarin, and amoxicillin. Discuss what type of written patient information is required for each of these drugs, if any.
A hospital pharmacy dispensed DrugX to an inpatient pursuant to a medication order. A MedGuide is available for DrugX. When the nurse administered the drug to the patient, the patient asked if there is any literature that she could read about the drug. The nurse replied that the hospital did not have any and the patient then asked to speak to a pharmacist. If you were the pharmacist, what should you do and what does the FDA guidance recommend?