Captain Mary Kremzner: For some medications, pharmacists are required to provide FDA-approved Medication Guides every time the drug is dispensed to help ensure the safe and effective use of drug products. But what about health care professionals who administer these drugs in hospitals or dialysis centers: are they required to fulfill the same professional obligations? Hi, I'm Captain Mary Kremzner and this is Drug Info Rounds brought to you by the pharmacists in FDA's Division of Drug Information. I'm joined today by two FDA pharmacists, Dr. Lindsay Davison and Commander Catherine Chew, who will help clarify some issues surrounding Medication Guides. So, Lindsay, the FDA has received comments from health care professionals saying they're uncertain about when they need to provide Medication Guides. So, what is the source of confusion?
Dr. Lindsay Davison: Well, their uncertainty is valid because health care professionals are sometimes administering medication several times a week or even daily to the very same patient. So providing a Medication Guide every time is not always realistic or helpful.
Captain Mary Kremzner: Are there circumstances when Medication Guides do not need to be provided?
Dr. Lindsay Davison: There are. A good example is an inpatient setting defined as a medical facility where patients receive care for longer than 24 hours. These include hospitals, hospice care and skilled nursing facilities. In settings like this, rather than provide a Medication Guide every time a drug is prescribed or dispensed, health care professionals should instruct their patients on the appropriate use of a drug, address potential side effects and answer any questions.
Captain Mary Kremzner: Cat, can you tell us a little bit about outpatient settings?
Commander Catherine Chew: Sure. First, any patient or patient's agent who requests a Medication Guide should receive one. Second, Medication Guides should be provided to patients in outpatient settings, when the drug will be administered without direct supervision from a health care professional. These types of settings could include community pharmacies, hospital-based ambulatory care units or apply to patient samples. Third, in outpatient settings when patients return often, like a dialysis center, health care professionals should provide a Medication Guide the first time a drug is dispensed. Fourth, if a Medication Guide has been materially changed it needs to be provided in all outpatient settings the first time a drug is dispensed following the change. Pharmaceutical companies notify health care professionals whenever material changes take place in Medication Guides; for example, when a new indication or new safety information is added. And finally, when a drug is subject to a REMS that includes specific requirements for reviewing or providing a medication guide, the Medication Guide must be provided in accordance with the terms of the REMS.
Captain Mary Kremzner: Lindsay, is there an easy way to keep track of all of this?
Dr. Lindsay Davison: There is. In November of 2011, the FDA published a guidance document with helpful information on when and where to distribute Medication Guides. It includes a quick-reference table about FDA's enforcement discretion policy, different inpatient and outpatient settings, and when you may or may not give the medication guide to that patient.
Captain Mary Kremzner: It seems like the FDA's guidance document will go a long way toward answering distribution questions for health care professionals. You can view the guidance document on the FDA's web site, along with a complete list of drugs that have Medication Guides. You can download Medication Guides there or request them from the drug sponsor. If you have questions about Medication Guides, call or email the FDA's Division of Drug Information.