“Medication Guides” are the paper handouts that are provided to patients in the US along with many prescription medicines. These guides contain FDA-approved information that addresses some specific issues about the medication.
By law, the FDA requires that pharmacies must provide the Medication Guide to the patient while dispensing these particular prescription medications. Many psychotropic medications require Medication Guides to be provided along with the medication. But, not all prescription medications require a Medication Guide to be provided to the patient by the pharmacy.
Why are medication guides required with some medications?
The FDA notes three reasons for the mandatory provision of medication guides to patients who are prescribed certain medications:
1. Certain information is necessary to prevent serious adverse effects
2. Patient decision-making should take into consideration information about a known serious side effect with that medication, or
3. Patient adherence to directions for the use of the medication is essential to its effectiveness.
Where can medication guides be found?
There are many places where we can find the Medication Guides.
1. Medication Guides are included in the “drug label” (Prescribing Information) for the medication, usually at its end.
2. The FDA’s website maintains a “Medication Guides database” in which the links go directly to the first page of the Medication Guide within the drug label.
3. The National Library of Medicine maintains a website called DailyMed that contains the drug label, medication guides, and links to other resources. For example, see the image below.
References
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U.S. Food And Drug Administration. Consumer medication guides. J Pain Palliat Care Pharmacother. 2010 Sep;24(3):298-301. doi: 10.3109/15360288.2010.503731. PubMed PMID: 20718653.
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