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U.S. Department of Health and Human Services

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Questions and Answers on Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)


Q1. Why did FDA publish a draft guidance on Medication Guides? 

A. FDA published a draft guidance on Medication Guides because the Agency has received comments from healthcare professionals and drug companies saying that they were confused about when they were supposed to distribute a Medication Guide in inpatient and outpatient settings where drugs are given to a healthcare professional for administration to a patient (e.g., in hospitals and dialysis centers). In these situations, the drug may be given daily or several times a week, and distributing a Medication Guide every time the drug is given may be difficult for healthcare professionals and not necessarily helpful for patients. FDA believes the draft guidance will help clarify when Medication Guides should be distributed and reduce some of the burden on the healthcare system.

Secondly, over the past several years, the Agency has, as a matter of policy, considered any new Medication Guide (or safety-related changes to an existing Medication Guide) to be part of a risk evaluation and mitigation strategy (REMS). The Agency has now determined that every Medication Guide will not necessarily be part of a REMS. Depending on the risks involved, the Agency will now approve some Medication Guides under only labeling regulations, and occasionally, also as part of a REMS. 

Q2. What is the source of confusion on how Medication Guides are distributed?  

A. A main source of confusion concerns whether or not the Agency's regulations on Medication Guide distribution apply to inpatient settings. Inpatient settings are medical facilities (e.g., hospital, extended care facility, nursing home or other facility) where a patient is admitted and receives care, room, and board for longer than 24 hours. Although the Agency's regulations state that Medication Guides are required to be distributed when each prescription is dispensed, some sections of the regulations suggest that these requirements are mainly intended for prescription medications used in outpatient settings without direct supervision by a health professional. The regulations do not describe how to handle Medication Guide distribution in inpatient settings. 

Q3. Is FDA concerned that patients are not getting the information they need about their medications?  

A. No, FDA is not concerned that patients are not getting the information they need about their medications. FDA is publishing this draft guidance to clarify how this information should be distributed to patients in inpatient and certain outpatient (i.e. dialysis and infusion centers) healthcare settings. For these patients, healthcare professionals will be available to provide counseling on medication for patients. FDA is still requiring that Medication Guides be distributed in outpatient settings when a drug that has a Medication Guide is dispensed directly to patients for self administration, or to their caregivers for administration to the patient. Furthermore, in the outpatient setting, the Medication Guide will beprovided the first time a drug is dispensed, when the Medication Guide is materially changed, and any time that that a patient or their caregiver asks. 

Q4. How will this guidance for industry resolve the confusion on Medication Guide distribution?  

A. The draft guidance will resolve the confusion on Medication Guide distribution by describing how FDA recommends distributing Medication Guides in inpatient and certain outpatient healthcare settings (e.g., dialysis and infusion centers). Page 7 of the guidance contains a helpful table that addresses the various settings. 

Q5. How will FDA determine if this draft guidance is effective in resolving the confusion on Medication Guides?  

A. FDA will determine if this draft guidance is effective in resolving the confusion on Medication Guide distribution based on the number and content of comments from healthcare professionals and drug companies on the draft guidance and the number of new requests to clarify the Medication Guide distribution requirements. 

Q6. Should we expect any more changes to Medication Guide processes?  

A. Yes, more changes to the Medication Guide processes should be expected. FDA's Office of Medical Policy is working on developing more useful patient information (Patient Medication Information or PMI) which may ultimately replace Medication Guides. Public meetings have been held to develop the concept of PMI and eventually, may lead to a regulation change. 

Q7. How will FDA determine what qualifies as a "material change" to a Medication Guide?  

A. FDA staff will make the determination of "material change" to a Medication Guide on a case-by-case basis depending on what information is being changed in the Medication Guide, and will notify the sponsor in the letter approving the change. 

Q8. Will a Medication Guide ever be required to be distributed to patients in inpatient healthcare settings?  

A. Yes, a Medication Guide may be required to be distributed to patients in inpatient healthcare settings in certain circumstances. The guidance states that for Medication Guides distributed under a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use (ETASU), the requirements for distribution of the Medication Guide as specified in the REMS will remain. For example, if a medication has a REMS with ETASU where a Medication Guide is an element of the REMS for dispensing to two patient populations, these patients will still continue to receive the Medication Guides as described in the REMS, regardless of whether they are in an inpatient setting. 

FDA also requires distribution of Medication Guides to patients in inpatient settings who request this information. 

Q9. Will the Medication Guide ever be required to be distributed if the REMS has elements to assure safe use (ETASU)?  

A. Yes. The guidance states that for Medication Guides distributed under REMS with elements to assure safe use (ETASU), the requirements for distribution of the Medication Guide as specified in the REMS will remain.  

Q10. Is the Agency currently requiring distribution of a Medication Guide every time a drug is dispensed in inpatient and certain outpatient (e.g., dialysis and infusion centers) healthcare settings?  

A. No. The draft guidance applies current Agency thinking on when a drug should be dispensed in these settings. Although the Agency may modify the guidance after reviewing any comments submitted, FDA does not intend to take enforcement action in the near term if Medication Guides are distributed as described in the guidance. When the guidance is finalized, it will reflect the Agency's current thinking on this matter. 

Q11. The guidance states that FDA intends to exercise enforcement discretion concerning distribution of a Medication Guide in an inpatient setting, except in certain situations. What is an example of an inpatient setting?  

A. An inpatient setting is a medical facility (e.g., hospital, extended care facility, nursing home or other facility) where a patient is admitted and receives care, room, and board for longer than 24 hours. The following are additional examples of inpatient settings:

  • Hospitals (acute care, psychiatric, children's)
  • Hospice Inpatient Services
  • Skilled Nursing Facilities (i.e., Nursing Homes, Rehabilitation Units)
  • Emergency Setting when the patient is then admitted to an inpatient unit (see Q13)
  • Same Day Surgery when the patient is then admitted to an inpatient unit postoperatively (see Q13)  

Q12. How are emergency room and day-surgery patients classified: inpatient or outpatient? 

A. If the drug is administered in the hospital by a healthcare professional and the patient is to continue the drug once discharged at home by self-administration, this is considered outpatient. However, if the patient is admitted to an inpatient facility following a same day surgery procedure or ER visit and the drug is subsequently administered by a healthcare professional within that facility, then they are considered an inpatient.

Examples of Outpatient Settings when drug is dispensed to a healthcare professional for administration to patients

(Health care service provided to a patient who is not admitted to a facility. Outpatient care may be provided in a doctor's office, clinic, the patient's home or hospital outpatient department): 

  • Dialysis Units
  • Chemotherapy Infusion Clinics
  • Rehabilitation Facilities (Physical Therapy)
  • Home Health (medication administered by a healthcare professional)

Examples of Outpatient Settings when drug is dispensed directly to a patient or caregiver:

  • Assisted Living Facilities
  • Emergency Room Settings when discharged to home
  • Home Hospice Care
  • Home Health (medication administered by the patient or caregiver)
  • Residential Treatment Facilities (halfway house for mental health, alcoholism, or chemical dependency)
  • Same Day Surgery when discharged to home
  • Urgent Care Facilities 

Q13. Has FDA's policy changed for considering every Medication Guide to be part of a REMS? 

A. Yes, FDA's policy has changed. FDA has determined that it is no longer necessary or appropriate to consider every Medication Guide to be an element of a REMS.  

Q14. How will the policy on Medication Guide-only REMS be implemented? 

A. The policy on Medication Guide-only REMS will be implemented by allowing drug sponsors to request removal of a REMS when the only REMS element is a Medication Guide and a timetable for assessment. Drug sponsors can refer to the draft guidance for discussion on this process. If the REMS is removed, the drug will still have a Medication Guide that will be required to be distributed according to FDA's regulations and the circumstances described in the draft guidance.  

Q15. When will this guidance be final? 

A. The comment period for this draft guidance will close on May 31, 2011. We will begin to work on the final guidance at that time. To allow for a thorough review and consideration of all comments and vetting through appropriate offices, we will make every effort to publish a final guidance by late fall 2011; however, the timing may be shifted depending on the volume and content of comments received.