Re: Development and Distribution of Patient Medication Information for Prescription Drugs; Request for Comment [Docket No.

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1 N Y L P I New York Lawyers For The Public Interest, Inc. 151 West 30 th Street, 11 th Floor New York, NY Tel Fax TTD Food and Drug Administration Division of Dockets Management (HFA-305) 5630 Fishers Land, Rm Rockville, MD October 29, 2010 Re: Development and Distribution of Patient Medication Information for Prescription Drugs; Request for Comment [Docket No. FDA-2010-N-0437] Dear Sir or Madam: New York Lawyers for the Public Interest (NYLPI) and our undersigned partners write to comment on the development and distribution of a standard, single document for communicating essential information about prescription drugs announced by the Food and Drug Administration (FDA) on August 27, 2010 (Fed. Reg ). We applaud the FDA for its intention to explore methods to replace several confusing and often inaccessible documents with one standardized patient medication information (PMI) document that is comprehensible and accessible for all patients. Our comments are directed at the following issues: (4) What accommodations might be needed to ensure that PMI is accessible to special populations? ; (2) What are the components of an effective framework for ensuring patient access to PMI? ; and, (1) How can we best ensure PMI quality and compliance with the content and format criteria? Regarding issue (4), we strongly encourage the FDA to ensure that any standardized PMI that is produced be communicated and accessible in a manner that any and all patients can understand. As you have already recognized, the framework for PMI development should include accommodations for individuals with low health literacy, the elderly, children, and patients with disabilities. However, there is one additional special population not mentioned in the request for comments which the FDA must also consider when developing its PMI framework: patients who are limited English proficient (LEP). As to issue (2), given current legal requirements and technological capabilities, as well as the practical realities for patients, we strongly recommend that pharmacies play the lead role in 1

2 ensuring the effective communication and patient safety with respect to prescription medications. Concerning issue (1), we agree with the FDA s suggestion that pharmaceutical companies should play a role in PMI development and that the FDA can most effectively play an oversight and surveillance role. Issue (4): What accommodations might be needed to ensure that PMI is accessible to special populations? Recommendation: PMI should be communicated in a language and format that all patients, including LEP patients, can understand. Nation-wide almost 4 billion prescriptions are written each year. 1 Given that over one-third of the total adult population of the United States is considered to have only basic or below basic health literacy, 2 it is often challenging for a proficient English-speaker to understand and act on the countless documents containing prescription drug information that accompany medications. For the over 24 million people in the United States who speak English less than very well 3 and are therefore considered LEP, these difficulties are only further compounded. The issue of PMI accessibility is closely linked to the issue of language barriers in prescription medication labels and highlights the importance of translation and interpretation of auxiliary medication information. Indeed the impact of language barriers on medication use is particularly important, given the complexity of directions patients receive, the serious implications of medication errors, the number of medications prescribed, and the patients responsibility for managing medications on their own. 4 Further, studies suggest that LEP patients do not have sufficient knowledge of medication or dosing instructions, and that this knowledge gap can result in significant problems with medication adherence. 5 The negative effects of inaccessibility due to language barriers, combined with poor efforts to overcome these barriers, leads LEP patients to make more medication and treatment errors and to be less likely to follow treatments appropriately. The lack of translation also results in increased risk that LEP individuals will take prescriptions in harmful amounts, become unknowingly addicted to controlled substances, experience potentially dangerous and unanticipated side- 1 National Health Law Program, Language Services Resources Guide For Pharmacists, 167 (Feb. 2010), available at 2 See Kutner, M., et. al., The Health Literacy of America s Adults: Results From the 2003 National Assessment of Adult Literacy U.S. Department of Education, Washington, DC: National Center for Education Statistics, available at 3 U.S. Bureau of the Census, American Community Survey, 2009, Table S0501, available at geo_id=01000us&-ds_name=acs_2009_1yr_g00_&-_lang=en&-redolog=false&-state=st. 4 Neilsen-Bohlman L, et. al., Health Literacy: A Prescription to End Confusion. Washington, DC: National Academy Press (2004); Budnick DS, et. al., National surveillance of emergency department visits for outpatient adverse drug events, JAMA. 2006;296(15): Id., citing Levya M., et. al., Health Literacy Among Spanish-speaking Latino parents with limited English proficiency. AMBUL PEDIATR. 2005;5(1):56 59; Westberg SM., Pharmacy-related health disparities experienced by non-english speaking patients: College of Pharmacy. University of Minnesota, Minnesota, USA;

3 effects, or combine substances in such a way that is hazardous to their health or the health of their children. It is no surprise that ensuring access to medication information in a patient s language can improve health outcomes. 6 Without consistent access to translated and standardized auxiliary medication information, though, millions of LEP individuals are rendered unable to fully understand such information and are deprived of the most effective care which jeopardizes their health and denies them their civil rights. This ineffective communication increases the incidence of improper treatment, incorrect dosage and unknowing addiction, as well as the related consequences of adverse drug interactions, reactions, and sometimes death. Patient nonadherence with prescription instructions due to low levels of health literacy and other factors is responsible for 22% of all hospitalizations nation-wide. This problem places additional burdens on already under-resourced emergency rooms and hospitals, and costs an extra $300 billion per year in healthcare spending. 7 Although the research focuses primarily on prescription medication labeling, the same principles of accessibility for LEP patients apply directly to the development of PMI. Just as it is critical that prescription instructions be translated and interpreted so that all patients can effectively understand how to take medications, so too is it critical that PMI be translated so that all consumers can weigh the risks and benefits of medication and understand other important information that accompanies their prescriptions. We recommend that the FDA integrates mandatory PMI translation requirements into the PMI development framework. This will help to ensure that such information is effectively communicated to all patients, including LEP patients. Issue (2): What are the components of an effective framework for ensuring patient access to PMI? Recommendation: Given their current legal responsibilities to ensure that important prescription medication information is accessible to all patients including LEP consumers, pharmacies should play an essential role in PMI translation and distribution. For each of the 4 billion prescriptions written every year, patients primarily rely on pharmacies to fill those prescriptions, and on the pharmacists who work there to help them understand more about their medication. As such, pharmacies themselves play perhaps the most critical role in ensuring that patients actually receive effective communication around prescription medication. Under Title VI of the Civil Rights Act of 1964 and federal regulations, federal funds may not be used in an intentionally discriminatory manner, 8 or in a way that creates a disparate impact on 6 Id., citing Westberg SM., et. al., Pharmacy-related health disparities experienced by non-english-speaking patients: impact of pharmaceutical care, J AM PHARM ASSOC. 2005;45(1): Shrank WH, et.al., Educating patients about their medications: the potential and limitations of written drug information, HEALTH AFFAIRS, 2007 May-Jun;26(3): U.S.C. 2000d. 3

4 the basis of race, color or national origin. 9 Discrimination under Title VI includes preventing meaningful access to federally funded services for patients who are LEP. 10 As such, people who are LEP are entitled to receive interpretation and translation services so that they may access programs that receive federal financial assistance on equal terms as everyone else. Given that pharmacies are considered a program or activity 11 under Title VI and receive federal financial assistance through Medicaid and Medicare payments, among other direct and indirect federal funding sources, these requirements apply to pharmacies. 12 Further, the Office of Civil Rights at Health and Human Services has issued a four-factor test to help recipients of federal funding assess whether they are in compliance with Title VI. 13 This guidance recognizes that different circumstances will require different levels of compliance and that recipients of federal funding will need to make an individualized assessment to balance the four factors. 14 As such, a small, independent pharmacy in a community with few patients who are LEP may not be required to provide the same level of language services as a chain pharmacy located in an area with a large population of patients who are LEP. Again, an example involving prescription medication labels underscores not only the importance of translating medication information, but also the ability and obligation of pharmacies to provide translation and interpretation services. A recent study by the New York Academy of Medicine found that New York City pharmacies overwhelmingly failed to provide their LEP customers with translated medication labels despite having the capacity to do so in at least some languages. 15 Notwithstanding civil rights obligations under Title VI of the Civil Rights Act of as well as state and local laws around prescription medication labeling and counseling, 17 pharmacies in New York were not voluntarily offering the language assistance services necessary to ensure their patients health and safety. As a result, NYLPI and Make the Road New York, a membership-led community based organization, were compelled to file a civil rights complaint with the New York State Attorney General s Office in order to ensure that the needs of New York City s LEP patients were being met. In response to this civil rights complaint, settlement agreements were entered into with all of the major chain pharmacies operating in New York, and a subsequent local law soon 9 See 45 C.F.R. 80.2, 80.3; see also (defining Federal financial assistance as including grants and loans of Federal funds, (2) the grant or donation of Federal property and interests in property... [and] any Federal agreement, arrangement, or other contract which has as one of its purposes the provision of assistance. ). 10 Lau v. Nichols, 414 U.S. 563 (1974). 11 See 42 U.S.C. 2000d-4a (defining program or activity ). 12 Id. See also 45 C.F.R. 80 app. A (listing examples of federal financial assistance) Fed. Reg (Aug ). 14 Id. See also U.S. Department of Health and Human Services, Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons, available at 15 Linda Weiss, et. al., Access to Multilingual Medication Instructions at New York City Pharmacies, JOURNAL OF URBAN HEALTH: BULLETIN OF THE NEW YORK ACADEMY OF MEDICINE, vol. 84, no. 6 (2007), pp U.S.C. 2000d. The United States Supreme Court has treated discrimination based on language as national origin discrimination. See Lau v. Nichols, 414 U.S. 563 (1974). 17 See N.Y. EDUC. LAW, 6800, et. seq. (2007); N.Y. COMP. CODES R. & REGS. tit. 8, 63.6 (2007); New York City Human Rights Law, N.Y. CITY CODE, tit. 8, 8-107(17) (2001). 4

5 followed. 18 Under the settlements, pharmacies including CVS, Costco, Target and Wal-Mart were required to make translated labels available in six languages and must add five more languages within six months of updating their computer systems to track language preference. A local law enacted in 2009 codified the settlement agreements and extended their provisions to cover all pharmacies with four or more locations in New York City. 19 At present, chain pharmacies in New York City must have the capacity to translate prescription medication labels and auxiliary medication information into at least 11 languages, and provide interpretation services to LEP patients. When NYLPI was advocating for translation and interpretation services in New York City, chain pharmacies often raised concerns as to the practical and economic feasibility of providing language assistance services. Current systems and technologies, however, demonstrate that these concerns are unfounded. Telephone-based interpretation services are available for the process of medication counseling and, more importantly for the present purposes, computer-based translation services for labels and other written materials are widely available and not expensive. Such services, including Meducation 20 and RxTran, 21 enable pharmacies to fill the language gap seamlessly and in a way that is consistent with a pharmacist s natural workflow, instead of expecting them to take additional or different steps to fill a prescription. Indeed, existing systems provide pharmacies with the ability to print on demand patient instructions, warning labels, and consumer medication information in a variety of languages. Importantly, these translation services are very reasonably priced, and in many cases can be provided to pharmacies for less than $2 a day. In addition, no federal law prohibits translation of PMI. Federal law does require that certain information, such as the patient name and expiration date, on the prescription container label be printed in English. 22 That said, the law expressly permits the translation of the label and, by extension, PMI into other languages. 23 Given current laws, technologies and obligations, large chain pharmacies nationwide are already responsible for facilitating LEP patients understanding of prescription information. This responsibility naturally should extend to the effective distribution of accessible, translated PMI. As the place where consumers would likely receive PMI, pharmacies have a responsibility to ensure that patients can access the auxiliary medication information in an effective way. Doing so will substantially improve the health and safety of LEP patients. 18 See New York State Office of Attorney General, Cuomo Announces Agreements With Major Pharmacies To Provide Customers With Prescription Medication Instructions In Their Primary Language, available at 19 N.Y.C. Administrative Code tit. 20, to -625 (2010). 20 See Meducation, 21 See RxTran, C.F.R (a), C.F.R (c)(1). This provision states that [a]ll words, statements, and other information required by or under authority of the act to appear on the [prescription] label or labeling shall appear thereon in the English language. Id. Nothing precludes the translation of auxiliary medication information into other languages. 5

6 Issue (1): How can we best ensure PMI quality and compliance with the content and format criteria? Recommendation: The FDA should explore the role that pharmaceutical companies can play in PMI development so that the ultimate standardized document is as accessible as possible. The FDA itself can most effectively play an oversight, coordination and surveillance role. In addition, pharmacies also bear responsibility for ensuring effective communication with patients. As the entities that currently manufacture both the medications as well as some of the auxiliary prescription information documents that already accompany prescriptions, pharmaceutical companies should play some role in developing PMI that are accessible, both in language and format, for all consumers. These companies are multinational corporations that operate internationally. For example, Pfizer, the world s largest research-based pharmaceutical company operates in over 40 countries; Johnson & Johnson operates in Given the global reach of these large pharmaceutical companies, they presumably already have the ability and capacity to translate prescription drug information into various languages. We strongly encourage the FDA to consider ways in which pharmaceutical companies can support PMI development so that they can be accessible for all patients, including LEP patients. In terms of the FDA s role in PMI development, previous FDA policy has eschewed oversight on auxiliary medication information. Until now, the FDA has primarily relied on private companies to self-regulate this important area. 25 This fragmented approach, however, has proved ineffective toward ensuring that all consumers especially LEP patients can access and understand medication information. For example, the government has established general guidelines concerning Consumer Medication Information (CMI), but its content is largely determined by private companies, including First DataBank and Medispan, that sell this information directly to pharmacies. The format of CMI, however, is principally determined by pharmacies. By contrast, the content and format of Patient Package Inserts (PPI) and guides for certain medications are regulated by the FDA. 26 With no single agency accountable for coordinating one type of information works in conjunction with another, patients are rendered helpless when attempting to educate themselves about their prescription medication. To remedy this problem, the FDA should instead take on a robust, centralized, oversight role in the development and enforcement of PMI that are accessible to all consumers, especially LEP consumers. In sum, we encourage the FDA to incorporate strong, affirmative language into its proposal regarding PMI so that such information is communicated in a language and format that all 24 See Shrank, William, et. al. Effect of Content and Format of Prescription Drug Labels on Readability, Understanding, and Medication Use: A Systematic Review, ANNALS OF PHARMACOLOGY, 2007 May Volume Id. 6

7 patients can understand. While the FDA can most effectively play an oversight and coordination role in ensuring standardized, accessible PMI, pharmaceutical companies and pharmacies should be responsible for PMI development and distribution, respectively. Thank you for your consideration. Sincerely, Nisha Agarwal Director, Health Justice Program New York Lawyers for the Public Interest Seth Cohen Staff Attorney/Equal Justice Works Fellow, Health Justice Program New York Lawyers for the Public Interest Joana Ramos, MSW Cancer Resources & Advocacy Chair, WASCLA Pharmacy Language Access Workgroup* Director, Washington Coalition for Prescribing Integrity* Seattle WA (*affiliation listed for identification purposes only) On behalf of the attached list of signatories. 7

8 Signatories I. Organizations Alliance to Develop Power AMOS Project Applied Research Center Asian and Pacific Islander American Health Forum Association of Clinicians for the Underserved California Immigrant Policy Center California Pan-Ethnic Health Network California Partnership Campaign for Community Change CASA de Maryland Coalition for Humane Immigrant Rights of Los Angeles Colorado Progressive Coalition Community Organizations in Action Community Service Society of NY Connecticut Citizen Action Group Cross-Cultural Communications Faith Action for Community Equity Granite State Organizing Project Grassroots Organizing Having Our Say Coalition Idaho Community Action Network Indian People's Action Interpret This Inc. ISAIAH Kazan State Medical Academy Korean Resource Center Mahoning Valley Organizing Collaborative Main Street Alliance Maine People's Alliance Make the Road New York Montana Organizing Project National Council on Interpreting in Health Care National Health Law Project (NHeLP) National Immigration Law Center National Korean American Service & Education Consortium Nebraska Appleseed Nebraska Urban Indian Health Coalition

9 New York Immigration Coalition NOAH North Carolina Fair Share Northwest Federation of Community Organizations Ocean State Action Oregon Action Organization of the NorthEast (Chicago) Philadelphia Unemployment Project Piedmont Geriatric Hospital Polyglot Systems, Inc. Progressive Leadership Association of Nevada Saint Joseph College South Carolina Fair Share Sunflower Community Action TakeAction Minnesota Tenants and Workers United Tennessee Citizen Action The Health Education and Literacy for Parents Project The New York Academy of Medicine United Action Connecticut University of Washington Medical Center Urban Epicenter Virginia Organizing Project Washington Community Action Network Washington State Coalition for Language Access (WASCLA) Western South Dakota Native American Organizing Project II. Individuals Lois Wessel, CFNP, Association of Clinicians for the Underserved Michael Lattif, Vice President, Avantpage Solanda Ramos, Quality & PI coordinator, Bon Secours St. Mary's Hospital Marjory Bancroft, Director, Cross-Cultural Communications Angela Jimenez, Administrator, CT DPH, Office of Multicultural Health Eliana Lobo, Supervisor - Interpreter Svs, Haraborview Medical Center Lilia Ziganshina, Head of Department of Clinical Pharmacology, Kazan State Medical Academy Cynthia Roat, National Consultant on Language Access in Health Care Iman Sharif, Chief, Division of General Pediatrics, Nemours/A.I. dupont Hospital for Children Charles Lee, President, Polyglot Systems, Inc.

10 Pamela Aselton, Graduate Program Director, Saint Joseph College Gea Caballero, Pharmacy Director, Sea Mar CHC Pharmacy Linda van Schaick, Director, The Health Education and Literacy for Parents Project Linda Weiss, Director of Evaluation, The New York Academy of Medicine