Pharmacists, prescribers, and other health care providers are required to provide patients or their caregiver with FDA-approved Medication Guides in certain circumstances to help ensure their safe and effective use.
Medication Guides must be provided each time a drug is dispensed directly to the patient or caregiver when used by the patient without direct supervision from a health care provider in outpatient settings such as community pharmacy or ambulatory care units.
In other outpatient settings such as in a clinic, dialysis, imaging or MRI facility, or infusion center, Medication Guides should be provided the first time a drug is dispensed when a health care provider is responsible for administration of the drug to the patient.
Medication Guides should also be provided in any outpatient setting if there have been material changes such as the addition of a new indication or new safety information.
But what about health care providers who administer drugs in inpatient settings such as hospitals or nursing homes?
Medication Guides do not need to be provided when a drug is dispensed in these inpatient settings. However, health care providers should counsel the patient by providing instructions on appropriate use of the drug, including what potential side effects may occur, follow-up that may be required, as well as answer any questions the patient may have.
In either setting, inpatient or outpatient, the prescriber may determine it is not in the patient’s best interest to receive a Medication Guide and direct that it not be provided to that patient.
However, Medication Guides must be provided if the patient or caregiver requests one, regardless of any other direction from the prescriber.
In either setting, Medication Guides must also be provided for drugs subject to a risk evaluation and mitigation strategy, or REMS, that includes specific requirements for reviewing or providing a Medication Guide.
FDA has published a guidance document titled, “Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies.” The guidance is available on FDA’s website and provides more specific direction on the regulations. The guidance also includes a handy quick-reference table, useful for determining when Medication Guides do and do not need to be provided.
For questions related to Medication Guides or REMS Medication Guide requirements, contact FDA’s Division of Drug Information.