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Medication Information for Patients with Limited English Proficiency: Lessons from the European Union

Published online by Cambridge University Press:  01 January 2021

Marsha Regenstein ,
Ellie Andres ,
Dylan Nelson ,
Stephanie David ,
Ruth Lopert  and
Richard Katz
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Extract

Access to clear and concise medication information is essential to support safe and effective use of prescription drugs. Patient misunderstanding of medication information is a common reason for non-adherence to medication regimens and a leading cause of outpatient medication errors and adverse drug events in the U.S. Medication errors are the most common source of risk to patient safety, leading to poor health outcomes, hospitalizations, and deaths. Over half a million adverse drug events occur in the outpatient setting each year at a cost of approximately $1 billion annually.

Nearly half of adults in the U.S. experience difficulty understanding and acting upon health information. Even individuals with high levels of general literacy may find medication information difficult to understand or use. The risk of misunderstanding medication information is compounded for patients with limited English proficiency (LEP) who may not have access to this information in their own language.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 4 , Winter 2012 , pp. 1025 - 1033
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

Skoglund, P. Isacson, D., and Kjellgren, K., “Analgesic Medication: Communication at Pharmacies,” Patient Education and Counseling 51, no. 2 (2003):155–161; Jenkins, L. Britten, N. N. Stevenson, F. Barber, N., and Bradley, C., “Developing and Using Quantitative Instruments for Measuring Doctor-Patient Communication about Drugs,” Patient Education and Counseling 50, no. 3 (2003): 273–278; Institute of Medicine, Preventing Medication Errors, Quality Chasm Series (Washington, D.C.: National Academies Press, 2006) [hereinafter cited as Preventing Medication Errors]; Institute of Medicine, Standardizing Medication Labels: Confusing Patients Less, Workshop Summary (Washington, D.C.: National Academies Press, 2008) [hereinafter cited as Workshop Summary].CrossRefGoogle Scholar
Barker, K. Mikeal, R. Pearson, R. Illig, N., and Morse, M., “Medication Errors in Nursing Homes and Small Hospitals,” American Journal of Hospital Pharmacy 39, no. 6 (1982): 987–991; Bates, D. Cullen, D. Laird, N. Petersen, L. Small, S. Servi, D. Laffel, G. Sweitzer, B. Shea, B., and Hallisey, R., “Incidence of Adverse Drug Events and Potential Adverse Drug Events: Implications for Prevention ADE Prevention Study Group,” JAMA 274, no. 1 (1995): 29–34; Dean, B. Allan, E. Barber, N., and Barker, K., “Comparison of Medication Errors in an American and a British Hospital,” American Journal of Health System Pharmacy 52, no. 22 (1995): 2543–2549; Classen, D. Pestotnik, S. Evans, R. Lloyd, J., and Burke, J., “Adverse Drug Events in Hospitalized Patients: Excess Length of Stay, Extra Costs, and Attributable Mortality,” JAMA 277, no. 4 (1997): 301–306; Cullen, D. Sweitzer, B. Bates, D. Burdick, E. Edmondson, A., and Leape, L., “Preventable Adverse Drug Events in Hospitalized Patients: A Comparative Study of Intensive Care and General Care Units,” Critical Care Medicine 25, no. 8 (1997): 1289–1297; Lesar, T. Briceland, L., and Stein, D., “Factors Related to Errors in Medication Prescribing,” JAMA 277, no. 4 (1997): 312–317; see Institute of Medicine (Workshop Summary), supra note 1; Kaushal, R. Bates, D. Landrigan, C. McKenna, K. Clapp, M. Federico, F., and Goldmann, D., “Medication Errors and Adverse Drug Events in Pediatric Inpatients,” JAMA 285, no. 16 (2001): 2114–2120.Google Scholar
See Institute of Medicine (Preventing Medication Errors), supra note 1.Google Scholar
Institute of Medicine, Health Literacy: A Prescription to End Confusion (Washington, D.C.: The National Academies Press, 2004).Google Scholar
Id.Google Scholar
David, R. and Rhee, M., “The Impact of Language as a Barrier to Effective Health Care in an Underserved Urban Hispanic Community,” Mt. Sinai Journal of Medicine 65, nos. 5 & 6 (1998): 393–397; Flores, G. Laws, M. Mayo, S. Zuckerman, B. Abreu, M. Medina, L., and Hardt, E., “Errors in Medical Interpretation and Their Potential Clinical Consequences in Pediatric Encounters,” Pediatrics 111, no. 1 (2003): 6–14; Levya, M. Sharif, I., and Ozuah, O., “Health Literacy Among Spanish-Speaking Latino Parents with Limited English Proficiency,” Ambulatory Pediatrics 5, no. 1 (2005): 56–59.Google Scholar
Fulton, J., “Medication Labeling Errors in Non-English-Speaking Patients in Letters and Comments,” Annals of Pharmacotheapy 39, no. 2 (2005): 386–387CrossRefGoogle Scholar
See Institute of Medicine (Preventing Medication Errors), supra note 1.Google Scholar
National Quality Forum, A Comprehensive Framework and Preferred Practices for Measuring and Reporting Cultural Competency: A Consensus Report, Washington, D.C., 2009; National Committee for Quality Assurance, Implementing Multicultural Health Care Standards, Washington, D.C., 2010; The Joint Commission, Advancing Effective Communication, Cultural Competence, and Patient- and Family-Centered Care: A Roadmap for Hospitals, Oakbrook Terrace, IL, 2010.Google Scholar
U.S. Census Bureau, “American Community Survey, 2011,” available at <http://factfinder2.census.gov/faces/table-services/jsf/pages/productview.xhtml?pid=ACS_11_1YR_S1601&prodType=table> (last visited December 11, 2012).+(last+visited+December+11,+2012).>Google Scholar
Id.Google Scholar
Flores, Laws, M. Mayo, S. Zuckerman, B. Abreu, M. Medina, L., and Hardt, E., “Errors in Medical Interpretation and Their Potential Clinical Consequences in Pediatric Encounters,” Pediatrics 111, no. 1 (2003): 6–14; Schillinger, D. Machtinger, E. Wang, F. Chen, L. Win, K. Palacios, J. Rodriguez, M., and Bindman, A., Language, Literacy, and Communication Regarding Medication in an Anticoagulation Clinic: Are Pictures Better Than Words? vol. 2 (Rockville, MD: Agency for Healthcare Research and Quality, 2008); Levya, M. Sharif, I., and Ozuah, O., “Health Literacy among Spanish-Speaking Latino Parents with Limited English Proficiency,” Ambulatory Pediatrics 5, no. 1 (2005): 56–59; Westberg, S., “Pharmacy-Related Health Disparities Experienced by Non-English Speaking Patients,” A Report to the College of Pharmacy at the University of Minnesota, available at <> (last visited December 10, 2012).CrossRefGoogle Scholar
42 U.S.C. §2000d (1964).Google Scholar
Spector, S. and Youdelman, M., “Analysis of State Pharmacy Laws: Impact of Pharmacy Laws on the Provision of Language Services,” National Health Law Program (2010), available at <http://www.aacp.org/resources/education/Documents/PharmacyLawBooklet%20FINAL.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
Id.Google Scholar
Executive Order No. 13166, 65 C.F.R. 159 (2000 comp.).Google Scholar
Bailey, S. Pandit, A. Curtis, L., and Wolf, M., “Availability of Spanish Prescription Labels: A Multi-State Pharmacy Survey,” Medical Care 47, no. 6 (2009): 707–710; Sharif, I. Lo, S., and Ozuah, P., “Availability of Spanish Prescription Labels,” Journal for Health Care for the Poor Underserved 17, no. 1 (2006): 65–69; Weiss, L. Gany, F. Rosenfeld, P. Carrasquillo, O. Sharif, I. Behar, E. Ambizas, E. Patel, P. Schwartz, L., and Mangione, R., “Access to Multilingual Medication Instructions at New York City Pharmacies,” Journal of Urban Health 84, no. 6 (2007): 742–754; Bradshaw, M. Tomany-Korman, S., and Flores, G., “Language Barriers to Prescriptions for Patients with Limited English Proficiency: A Survey of Pharmacies,” Pediatrics 120, no. 2 (2007): E225-e235; Bailey, S. Agarwal, N. Sleath, B. Gumusoglu, S. Wolf, M. S., “Improving Drug Labeling and Counseling for Limited English Proficient Adults,” Journal of Health Care for the Poor and Underserved 22, no. 4 (2011): 1131–1143.CrossRefGoogle Scholar
Mitka, M., “For Non-English Speakers, Drug Label Instructions Can Be Lost in Translation,” JAMA 297, no. 23 (2007): 2575–2577.CrossRefGoogle Scholar
Bailey, S. Pandit, A. Curtis, L., and Wolf, M., “Availability of Spanish Prescription Labels: A Multi-State Pharmacy Survey,” Medical Care 47, no. 6 (2009): 707–710; Zargarzadeh, A. and Law, A., “Access to Multilingual Prescription Labels and Verbal Translation Services in California,” Research in Social and Administrative Pharmacy 7, no. 4 (2011): 338–346; Sharif, I. and Tse, J., “Accuracy of Computer-Generated, Spanish-Language Medicine Labels,” Pediatrics 125, no. 5 (2010): 960–965.CrossRefGoogle Scholar
See Institute of Medicine (Workshop Summary), supra note 1; Shrank, W. H. Agnew-Blais, J. Choudhry, N. K. Wolf, M. S. Kesselheim, A.S. Avorn, J., and Shekelle, J., “The Variability and Quality of Medication Container Labels,” Archives of Internal Medicine 167, no. 16 (2007): 1760–1765.CrossRefGoogle Scholar
See Specter, and Youdelman, , supra note 14.Google Scholar
21 C.F.R. pt. 1306.14 & 1306.24 (2010).CrossRefGoogle Scholar
Shrank, W. H. Agnew-Blais, J. Choudhry, N. K. Wolf, M. S. Kesselheim, A. S. Avorn, J., and Shekelle, J., “The Variability and Quality of Medication Container Labels,” Archives of Internal Medicine 167, no. 16 (2007): 1760–1765.CrossRefGoogle Scholar
New York City Council, “Int 0859–2008 Provision of Language Assistance Services in Pharmacies,” 2009, available at <http://www.rxtran.com/Pharmacy-Translation-Law-New-York-City-2009.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
See Specter, and Youdelman, , supra note 14. Make the Road New York, “VICTORY! New York State Passes Landmark SafeRx Legislation,” 2012, available at <http://www.maketheroad.org/article.php?ID=2236> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
See Specter, and Youdelman, , supra note 14; California Senate Bill 472, Laws of California (2007); California Board of Pharmacy, “Patient-Centered Labels for Prescription Drug Containers,” 2010, California Code of Regulations 16 § 1707.5, available at <http://www.pharmacy.ca.gov/laws_regs/1707_5_final.pdf> (last visited December 10, 2012); California Board of Pharmacy, “Translations of Pill Directions,” available at <http://www.pharmacy.ca.gov/publications/translations.shtml> (last visited December 10, 2012).+(last+visited+December+10,+2012);+California+Board+of+Pharmacy,+“Translations+of+Pill+Directions,”+available+at++(last+visited+December+10,+2012).>Google Scholar
21 C.F.R. pt. 201 (1998).Google Scholar
Wolf, M. S. Davis, T. C. Shrank, W. H. Neuberger, M., and Parker, R. M., “A Critical Review of FDA-Approved Medication Guides,” Patient Education and Counseling 62, no. 3 (2006): 316–322; U.S. Food and Drug Administration, “Medication Guides,” 2011, available at <http://www.fda.gov/Drugs/DrugSafety/UCM085729> (last visited December 10, 2012).CrossRefGoogle Scholar
Kimberlin, C. and Winterstein, A., Expert and Consumer Evaluation of Consumer Medication Information-2008, Final Report to the U.S. Department of Health and Human Services and the Food and Drug Administration, available at <http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ReportsBudgets/UCM163783.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
21 C.F.R. pt. 201 (1998).Google Scholar
Id.Google Scholar
U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of New Drugs, NDA's: Foreign Language Labeling, Manual of Policies and Procedures (Publication No. MAPP-6020.7), 2004, available at <http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082005.pdf> (last visited December 10, 2012). (last visited December 10, 2012).' href=https://scholar.google.com/scholar?q=U.S.+Food+and+Drug+Administration+Center+for+Drug+Evaluation+and+Research+Office+of+New+Drugs,+NDA's:+Foreign+Language+Labeling,+Manual+of+Policies+and+Procedures+(Publication+No.+MAPP-6020.7),+2004,+available+at++(last+visited+December+10,+2012).>Google Scholar
21 C.F.R. pt. 310 (2009).Google Scholar
U.S. Food and Drug Administration, Guidance Drug Safety Information – FDA's Communication to the Public, 2007, available at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072281.pdf> (last visited December 10, 2012). (last visited December 10, 2012).' href=https://scholar.google.com/scholar?q=U.S.+Food+and+Drug+Administration,+Guidance+Drug+Safety+Information+–+FDA's+Communication+to+the+Public,+2007,+available+at++(last+visited+December+10,+2012).>Google Scholar
Svarstad, B. and Mount, J., “Evaluation of Written Prescription Information Provided in Community Pharmacies,” Final Report to the U.S. Department of Health and Human Services & the Food and Drug Administration, 2001, available at <http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm175779.htm> (last visited December 11, 2012).+(last+visited+December+11,+2012).>Google Scholar
21 C.F.R. pt. 310 (2009).Google Scholar
U.S. Government Accountability Office, European Union Drug Approval, Overview of New European Medicines Evaluation Agency and Approval Process, Publication No. GAO-96-71 (1996), available at <http://www.legistorm.com/showFile/L2xzX3Njb3JlL2dhby9wZGYvMTk5Ni80/ful26458.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
European Medicines Agency, “About Us,” 2011, available at <http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000235.jsp&murl=menus/about_us/about_us.jsp&mid> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
Heads of Medicines Agencies, “The Approval System,” 2011, available at <http://www.hma.eu/47-html> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
See U.S. Government Accountability Office, supra note 38.Google Scholar
Id.Google Scholar
Applicant companies must translate English-language versions of medication information into 24 languages, for a total of 25 languages, plus Braille. These 25 languages consist of Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Italian, Latvian, Lithuanian, Maltese, Norwegian, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish, and Swedish. Twenty three of these 25 languages are official languages of the E.U. Norwegian and Icelandic are not official languages of the E.U., but Norway and Iceland take part in the Agreement on the European Economic Area, which includes them in many E.U. processes that reduce trade barriers, including the Centralized Procedure. Additionally, Croatia is not a member of the E.U., but is widely expected to become a member on July 1, 2013, and EMA regulators have directed companies to translate new medication information into Croatian. Braille translations must be available in all E.U. countries at the consumer's request. In countries with multiple official languages (e.g., Belgium), translations must be made available in each of the official languages of that country. Irish is the only official E.U. language not required for translation. The E.U. recognizes five regional languages as “semi-official” languages, such as Catalan, but none is required for medication information translation.Google Scholar
European Medicines Agency, “Operational Procedure on the Linguistic Review Process of Product Information in the Centralised Procedure – Human,” 2011, available at <http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500005250.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
Id.Google Scholar
European Medicines Agency, “Working Group on Quality Review of Documents,” 2011, available at <http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_00034.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac0580028dd6> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
Mayberry, P., “Current Trends in Pharmaceutical Packaging and Distribution Practices – US Versus the EU,” US Pharmacy Review, 2004, available at <http://www.touchbriefings.com/pdf/1092/Mayberry_ref.pdf> (last visited December 11, 2012).+(last+visited+December+11,+2012).>Google Scholar
European Parliament and the Council of the European Union, “Directive 2004/27/EC,” 2004, available at <http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004481.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
Id.Google Scholar
European Commission, “Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Community,” 2008, available at <http://ec.europa.eu/health/files/eudralex/vol-2/c/bluebox_02_2008_en.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
See European Parliament and the Council of the European Union, supra note 48.Google Scholar
Id.Google Scholar
Id.Google Scholar
See European Commission, supra note 50.Google Scholar
Fuchs, J. Banow, S. Görbert, N., and Hippius, M., “Importance of Package Insert Information in the European Union,” Pharmaceutical Industry 69, no. 2 (2007): 165–172.Google Scholar
European Commission, Guidance Concerning Consultations with Target Patient Groups for the Package Leaflet, 2006, available at <http://ec.europa.eu/health/files/eudralex/vol-2/c/user_consultation_200605_en.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
Id.Google Scholar
See European Parliament and the Council of the European Union, supra note 48.Google Scholar
See European Medicines Agency, supra note 46.Google Scholar
The guidance does not specify the precise translation process or method (e.g., back translation) pharmaceutical manufacturers must use to prepare the translations. For more information, see European Commission, Guideline on the Readability of the Labeling and Package Leaflet of Medicinal Products for Human Use, available at <http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
Heidenreich, K., “Dialogue Between Companies and the EMEA Regarding the Centralized Procedure From an Industry's Point of View,” Drug Information Journal 40, no. 1 (2006): 15–21.CrossRefGoogle Scholar
Personal communication with a pharmaceutical executive, 2011.Google Scholar
Id.Google Scholar
Id.Google Scholar
See U.S. Census Bureau, supra note 10; Institute of Medicine (Workshop Summary), supra note 1.Google Scholar
See Heidenreich, , supra note 61.Google Scholar