Discussion

Pharmaceutical regulatory policies in the U.S. and E.U. have addressed the need for information to support consumers' safe use of medications, with the E.U. taking explicit steps to mandate the availability of the information in the official languages of its member states. Most attention in the U.S. has focused on the dispensing label to convey information to patients about the medication they have been prescribed and their treatment regimen. Other forms of consumer-directed information (patient package insert and medication guides) are required by the FDA, although one of the most common forms of information--the CMI that is usually stapled to the prescription at the point of purchase--is unregulated and highly variable. As noted above, the FDA does not require medication information to be available in any language other than English, despite an acknowledged need for the information, a rapidly growing LEP population, and an appreciation of the cost to patients and the health system from medication errors.

The drug approval process in the E.U. provides a clear example of how readily medication information can be made available in multiple languages. Embedding the development of approximately two dozen translations of medication information in the marketing approval process accomplishes several things. First, pharmaceutical manufacturers have a strong incentive to complete all required translations expeditiously, since drug approval is contingent upon this process and a review of the documents is incorporated into the drug approval timeline. Second, bundling multiple translations into a single requirement means that new member states that participate in the EMA approval process have their official languages automatically included. This eliminates often contentious debates about the appropriate threshold of market penetration of various language groups for translating documents into particular languages. Finally, extremely narrow time windows for submission of translations to the EMA and the review of those translations at the country level support a process that does not substantially delay market entry.

Pharmaceutical manufacturers in the E.U. reportedly find the translation requirements to be burdensome, but they do not complain that they are technologically or organizationally complex. According to representatives from the EMA, companies routinely comply with the translation requirements and are able to submit documents in multiple languages, generally within the scheduled timeframes. Drug applications are often prepared through contractual relationships with translation firms that are familiar with the E.U. requirements related to quality and timeliness. While not without cost, the translations do not appear to add significantly to the cost of preparing an application for marketing approval.

The E.U. experience should lay to rest the notion that the translation of medication information into multiple languages is an impossible or even impractical task. Requiring pharmaceutical companies to prepare translations of medication information in the official languages of the E.U. as part of the drug approval process, according to clearly specified standards and criteria, has resulted in transformational practices that are now taken for granted.

Despite the differences in practices between the E.U. and the U.S., the E.U. example can serve as a model for the U.S. to improve the quality and availability of medication information in LEP patients' own languages. Requirements related to the translation of medication information on the part of manufacturers, for information already regulated by the FDA, could be incorporated into the U.S. drug application process. Uniform translations could be distributed along with medications from manufacturers to pharmacies across the U.S., where they could accompany prescriptions at the point of sale. The proposed process would replicate the information included in E.U. packaging without disrupting the pharmacy's dispensing function.

The focus on the pharmacy and the prescription label holds promise for improvement, but so does an equal spotlight on the drug manufacturers, whose customers make up a much more linguistically diverse group than those of the typical retail drugstore. Many of the pharmaceutical companies responsible for providing translations for the marketing approval process in the E.U. are the same companies selling pharmaceuticals in the U.S., and thus, already have some capacity to provide translations of medication information in many of the languages spoken by LEP persons in the U.S. Combining a requirement for uniform, clear, and understandable medication information in multiple languages at both the pharmacy and pharmaceutical manufacturer levels could substantially advance the safety of medication use among persons with limited English proficiency across the U.S.


 

Marsha Regenstein, Ph.D., M.C.P.,is a Professor in the Department of Health Policy at the George Washington University School of Public Health and Health Services in Washington, D.C. and served as the Director of Speaking Together: National Language Services Network.

Ellie Andres, M.P.H.,is a Senior Research Associate in the Department of Health Policy at the George Washington University School of Public Health and Health Services.

Dylan Nelsonis a Senior Research Assistant in the Department of Health Policy at the George Washington University School of Public Health and Health Services.

Stephanie David, J.D., M.P.H.,is an Assistant Research Professor in the Department of Health Policy at the George Washington University School of Public Health and Health Services.

Ruth Lopert, B.Sc, B.Med., M.Med.Sc, F.A.F.P.H.M.,is a Visiting Professor in the Department of Health Policy at the George Washington University School of Public Health and Health Services.

Richard Katz, M.D.,is the Bloedorn Professor of Medicine and Director of the Division of Cardiology at the George Washington University Medical Faculty Associates.