# Presentation: 285568

## Drug Labeling for Limited English Proficiency (LEP)

Kevin Outterson
WVU College of Law
Dec. 7-8, 2005
Kevin.Outterson@mail.wvu.edu

- Kevin Outterson
- WVU College of Law
- Dec. 7-8, 2005
- Kevin.Outterson@mail.wvu.edu

- FDA’s Communication of Drug Safety Information Hearing

## “In 2000, 4.4 million households encompassing 11.9 million people were linguistically isolated.  These numbers were significantly higher than in 1990, when 2.9 million households and 7.7 million people lived in those households.”

- US Census Bureau, Language Use and English-Speaking Ability:  2000 (Oct. 2003)

- Source:  US Census (2003)

## CONTRAINDICACIONESNEXIUM está contraindicado en pacientes con hipersensibilidad conocida a algún componente de la fórmula o a los benzimidazoles sustituidos. 

**CONTRAINDICACIONES**NEXIUM está contraindicado en pacientes con hipersensibilidad conocida a algún componente de la fórmula o a los benzimidazoles sustituidos.

## FDA Nexium Label

## LEP & Health

- LEP hinders access to care and prevention
- LEP compromises patient understanding of treatment advice
- LEP can lead to misdiagnosis and medical error

- Sources: Woloshin, JGIM, 12:472-477 (Aug 1997); Woloshin & Bickell, JAMA 273:724-727 (1995); RWJ Foundation (Dec. 12, 2001); Anderson, et al., AmJPrevMed 24(3S):68-79 (2003); Ngo-Metzger, et al., JGIM, 18:44-51 (Jan. 2003).

## LEP Rx

- More than 25% of LEP did not fully understand the prescription instructions (cmp. 2% control)
- Vietnamese and Chinese LEP patients value written health information and prescription medications in their native languages
- Provision of interpreters to LEP patients roughly triples scripts written and filled

- Sources  SUNY Brooklyn/The Access Health Project 2002; Ngo-Metzger, et al., JGIM 18:44-51 (Jan. 2003); Jacobs, et al., AJPubH 94:866 (May 2004).

## LEP Rx

- Not mentioned in HHS LEP Guidance 68 Fed. Reg.47311-47323 (Aug. 8, 2003)
- Not mentioned in National Standards for Culturally and Linguistically Appropriate Services in Health Care (HHS OMH, March 2001)
- Dual-language Rx labeling permitted but not required under MAPP 6020.7 (CDER OND, July 9, 2004)

## LEP and Rx Importation

-    “FDA remains concerned about...drugs obtained from foreign sources...
-    The labeling of the drug may not be in English and therefore important information regarding dosage and side effects may not be available to the consumer.”

- Testimony of William Hubbard, US Senate, Apr. 27, 2004

## FDA Border Seizures 2003Top Countries of Origin

- Canada
- India
- Thailand
- Philippines

- Japan
- Netherlands
- Taiwan
- UK

- Testimony of William Hubbard, US Senate, Apr. 27, 2004

## Top 10 LEP Languages

- Spanish 				      7,931,848
- Chinese	   	    	    	   	571,123
- Vietnamese	  	    	   	326,971
- Korean		 	    	   	264,420
- Russian			    	   	192,294
- French 				   	145,580
- Portuguese			   	118,723
- Polish			    	   	112,487
- Italian			            	111,249
- Japanese			     	  89,677

- Language spoken at home, speaks English ‘not well’ or ‘not at all’
- US Census 2003

## LEP Languages 11-20

- French Creole				  85,598
- Tagalog			    		  85,217
- German			    		  84,254
- Arabic					  71,128
- Armenian				  45,685
- Persian					  43,135
- Greek					  37,562
- Gujarathi					  30,340
- Urdu					  26,146
- Hindi					  19,936

- Language spoken at home, speaks English ‘not well’ or ‘not at all’
- US Census 2003

## OCR Title VI Safe Harbor

- < 100   			Oral translation
- <1000 or 5%		Translation of vital documents
- <3000 or 10%		Translation of all documents

**What Should PhRMA Companies Do?**

## Slide 14

## Accurate translations in multiple languages should be available for all retail pharmacies to use as needed.  Make side-by-side translations available

- Patient leaflets should be translated under supervision of the pharmaceutical companies and reviewed by an FDA panel ... consumer focus groups should validate the leaflets

- CMS should track ... the availability and accuracy of patient education materials (in multiple languages)...

## Accurate translations in multiple languages should be available for all retail pharmacies to use as needed.  Make side-by-side translations available

- Patient leaflets should be translated under supervision of the pharmaceutical companies and reviewed by an FDA panel ... consumer focus groups should validate the leaflets

- CMS should track ... the availability and accuracy of patient education materials (in multiple languages)...

## Patient Education 

**Lansoprazole capsules**

- Patient Education

- _What are lansoprazole capsules?_LANSOPRAZOLE (Prevacid®) prevents the production of acid in the stomach. It reduces symptoms and prevents injury to the esophagus or stomach in patients with gastroesophageal reflux disease (GERD) or ulcers. Lansoprazole is also useful in conditions that produce too much stomach acid such as Zollinger-Ellison syndrome. Generic lansoprazole capsules are not yet available.

## Options

- Revise OCR/HHS LEP regulations to require compliance by all drug companies with Title VI
- Revise MAPP 6020.7 to require distribution to LEP patients of appropriate FDA-approved or foreign NDRA-approved labels and patient educational materials in languages other than English

## Options

- Permit importation of personal use Rx by LEP patients
- Monitor drug company use of foreign-language materials not approved by either FDA or an appropriate foreign NDRA
- All of the above should be done in consultation with the LEP communities