Medication Information in the U.S.
In the U.S., there are a number of ways by which medication information is presented and distributed to patients. When filling prescriptions at a pharmacy, individuals may receive four types of patient medication information: the prescription container label, medication guide, package insert, and consumer medication information (see Table 1 omitted).
Prescription Container Labels
The prescription container label is the primary source of medication information used by patients because it is affixed to the medication container and is therefore less likely to be disposed of or lost. All states have laws regulating container labels. Most state provisions mirror federal Food and Drug Administration (FDA) standards for the content of container labels and require that the label include the name of the drug, patient, physician and pharmacy, as well as the “Rx number” and refill status. The label also contains dosing and administration instructions as provided by the patient's physician, as well as auxiliary warning statements, often presented in a variety of colors with different pictures (e.g., may cause drowsiness; avoid alcohol while taking this medication).
Efforts to ensure language access related to prescription drugs tend to target the prescription container label generated by the pharmacy. In September 2009, New York City became the first locality in the U.S. to require translation services in certain pharmacies. Among other requirements, New York City's law mandates translation of container labels into the top seven languages spoken by LEP persons in the city. New York City's statute followed a civil rights complaint brought against several chain pharmacies in New York State. As part of the settlement, the chain stores involved were required to translate prescription labels into eleven languages by May 2010. On March 30, 2012, New York State approved legislation essentially expanding the New York City translation requirement to benefit individuals with LEP throughout the state. Additionally, recent legislation in California requires the Board of Pharmacy to publish translations of prescription label instructions in at least five languages other than English on its website, in order to facilitate the use of translations in California pharmacies.
Medication Guides
In 1998, the FDA issued regulations requiring drug manufacturers to provide consumers with medication guides (Med Guides), 1-2 page paper handouts for a limited number of drugs that the FDA considers to “pose a serious and significant public health concern.” The guides are currently available for approximately 250 different drugs and are intended to help patients avoid serious adverse events. Med Guides are developed by the pharmaceutical manufacturer and are subject to FDA approval. A 2008 evaluation of medication information commissioned by the FDA found that very few patients received Med Guides and many pharmacies were not aware of their responsibility to provide them to patients.
While the FDA requires that Med Guides be written in English, in non-technical, understandable language without promotional tone or content, it does not require them to be translated into languages other than English. At the time the regulation was issued, the FDA acknowledged public concerns about the availability of Med Guides in Spanish and other languages and encouraged manufacturers to develop Med Guides in languages other than English. However, translated Med Guides are not subject to FDA approval and the agency has asserted that it will not review versions of labeling in languages other than English, whether as part of a new or supplemental drug application.
Patient Package Inserts
In addition to medication guides, the FDA also maintains regulatory oversight for consumer-directed information for oral contraceptives and certain products containing estrogens. This information is in the form of a patient package insert (PPI), typically presented as a folded leaflet inside the unit-of-use packaging. Each PPI is developed by the drug's manufacturer, who may also voluntarily provide PPIs for other types of drugs. Although PPI regulations do not specifically state whether the information must appear in English or any other language, it is presumed to be required in English since the information is necessary for FDA approval.
Consumer Medication Information
Consumer medication information (CMI) includes information on the medication's purpose, indications and contraindications, side effects, and warnings; it is often stapled to the outside or placed inside the pharmacy-provided prescription bag. Although pharmacies are not required to provide CMI to consumers, most do so voluntarily, providing information that they either develop internally or purchase through third-party vendors. Pharmacy practices vary, with some pharmacies providing CMI documents only for new prescriptions and others including them routinely with all prescription medications. Unlike Med Guides and Patient Package Inserts, CMI documents are not reviewed, approved or regulated by the FDA.
Over the past two decades, the value of the CMI as a patient education tool has been called into question, in part because of variability in the quality of the information and lack of clear standards and regulatory oversight governing CMI content and availability. Nevertheless, CMI is one of few sources of medication information in the U.S. that has included some limited discussion of availability in languages other than English.
