This blog on Pharmacy Language Requirements rightfully belongs to our subsidiary RxTran, but since our CEO Brian Kratt is standing today to deliver a presentation on nationwide pharmacy language laws and options for pharmacies to offer language services, I thought it only right to make it my blog topic.

Increasingly, pharmacies recognize the mandates to supply language services for limited English proficiency (LEP) patients, and they look to industry leaders to discover what options exist for offering language services. And though it sounds like bragging, RxTran is the only pharmacy language service provider to satisfy all current and anticipated future requirements for US pharmacies. We believe this is because of the difficulty in capturing and translating prescription SIGs, or Directions for Use.

Here is an overview of some of the major pharmacy language laws in the US today. (Please note that while this is longer than our typical blog, there is much to cover when it comes to pharmacy language regulations.)

Federal Pharmacy Language Laws

Federally, there are quite a few mandates that require pharmacies to provide language services. Most notable among these requirements are Title VI of the Civil Rights Act of 1964, Executive Order 13166, and the Medco Settlement. In the last decade, the US Department of Health and Human Services (HHS) and the Department of Justice (DOJ) started applying Title VI aggressively to protect national origin minorities with limited English proficiency (LEP) in healthcare settings.

Pharmacy Language Requirements Under Title VI of the Civil Rights Act of 1964

Under Title VI of the Civil Rights Act of 1964, all healthcare providers and recipients of federal financial assistance (including Medicare and Medicaid) are required to take reasonable steps to ensure meaningful access to their programs by limited English proficient (LEP) individuals.

Title VI prohibits discrimination on the basis of race, color and national origin in programs and activities receiving federal financial assistance.

Since most pharmacies in the US are recipients of federal funds, directly or indirectly, their activities fall under Title VI provisions. For example, a pharmacy that serves Medicare or Medicaid patients would be subject to Title VI.

If an LEP individual feels their rights were violated by not having access to prescription information in a language they understand, the individual can file a civil rights complaint with the Office of Civil Rights (OCR), or have someone else file on their behalf. Some complaints must be filed within 180 days of when the LEP individual first believed their rights were violated.

The OCR investigates civil rights to find out if there is discrimination or violation of the law and takes action to correct problems. Previous complaints to the OCR resulted in the Medco Settlement.

Executive Order 13166 and Pharmacy Language Requirements

On August 11, 2000, President Bill Clinton signed Executive Order 13166 to “improve access to federally conducted and federally assisted programs and activities for persons who, as a result of national origin, are limited in their English proficiency (LEP).”

The Executive Order requires all Federal agencies to evaluate their services and identify needed services for the LEP population and to develop and implement a system to provide meaningful access to those services.

The two main areas of Executive Order 13166 are:

1. Develop and implement a system to provide LEP individuals with meaningful access to agency services
2. Agencies that provide Federal financial assistance must issue guidance to all recipients of Federal funding on their legal obligation to provide meaningful access to LEP individuals under Title VI of the Civil Rights Act of 1964 and how to implement these regulations.

The key terminology in this order are to take “reasonable steps to ensure meaningful access.”

On February 17, 2011, US Attorney General Eric Holder issued a memorandum that reaffirmed Executive Order 13166’s mandate and renewed the Federal government’s commitment to language access.

Pharmacy Language Services Under Medco Health Solutions Settlement

Medco is a Pharmacy Benefits Management company that provides pharmacy services for over 65 million private and public employers, health plans, labor unions, government agencies and individuals served by Medicare Part D Prescription Drug Plans. Medco’s mail-order business is the largest mail-order pharmacy operation in the US. Medco Pharmacy operates 10 mail-order pharmacies and partners with a nationwide network of approximately 60,000 retail pharmacies.

A Spanish-speaking member of Medco launched a complaint with the Office of Civil Rights (OCR). The complaint alleged that Medco failed to provide LEP members with meaningful access to mail-order pharmacy services and other pharmacy benefit management services. The OCR launched an investigation, which resulted in the Medco settlement.

On June 22, 2009, the Office of Civil Rights (OCR) and Medco announced an agreement to settle the dispute. Medco agreed to provide language access accommodations. Medco agreed to address the issues in the complaint and provided OCR with assurance that it would implement measures to provide language assistance services to LEP members.

In the settlement agreement, Medco agreed to:

• Expand its Spanish-speaking call center team, and use On-Demand Phone Interpreting for other languages.
• Transfer calls to bilingual consulting pharmacists to discuss pharmacist-related information
• Allow members to specify the language they prefer to communicate in, and use that preference to translate written materials and interpreted calls
• Create policies, guidelines and communication materials for communicating with members in languages other than English
• Notify LEP members of the language services provided

The Medco settlement is important because it sets the precedent for all pharmacies of this size and for all mail order pharmacies to provide language services for LEP patients.

State Pharmacy Language Requirements

Beyond the federal laws that mandate pharmacies provide language services, several states have also taken up the issue and have legislation requiring pharmacies to provide language access. As the LEP population grows, so does interest at the state level in requiring pharmacies to offer language services.

State-By-State Assessment of Pharmacy Language Laws By National Health Law Program (NHeLP)

In 2010, NHeLP (National Health Law Program) released Analysis of State Pharmacy Laws, a study that reviews federal and state regulations regarding pharmacy provision of language services for people with limited English proficiency.

According to NHeLP, virtually all states have requirements regarding oral counseling and distribution of written materials. To comply with these requirements, pharmacists must effectively communicate with all of their patients, not only those who speak English.

Highlights of the NHeLP findings that support language services:

• 48 states have requirements regarding oral counseling
• 33 states require a process for counseling when the patient is not in the pharmacy
• 28 states require pharmacists to inform patients of substitution of a generic drug for a brand name drug, either orally or in writing
• 24 states require pharmacists to distribute written information to patients

Currently, four states have specific laws that require pharmacies to provide services in languages other than English: California, New York, North Carolina and Texas. The legislation in California and New York has been most notable. As legislation in these states gains momentum, other states and groups look to introduce similar legislation based on these models.

California’s Pharmacy Language Legislation

California has had movement in recent years regarding pharmacy language laws with State Bills 853, 472 and 204.

California SB 853 (2003)

The State of California passed SB 853 in 2003, mandating that all California health plans provide language assistance services to their enrollees. The legislation stipulates that all vital documents, including medication labels and instructions, must be translated into threshold languages and interpretation services made available to enrollees.

California SB 472 (2007)

California Senate Bill SB 472 was signed by Governor Arnold Schwarzenegger on October 11, 2007. The Bill required that by January 1, 2011, California adopt a standardized prescription drug label. Specifically, the Bill tasked the California State Board of Pharmacy to design such a standardized, patient-centered, prescription drug label and mandate its use by state pharmacies on all prescription medication dispensed in California.

The California law states that pharmacies must provide written notification (that follows strict guidelines) of the availability of free language services. The CA Board of Pharmacy has provided translated notifications (signs) and sent them out to all CA pharmacies in April 2013. As part of their license renewal process, pharmacies are being required to at minimum sign up for and provide interpreting services.

California currently has standardized SIGs translated into 5 languages—Spanish, Chinese, Korean, Russian and Vietnamese—and available on the CA Board of Pharmacy’s website. Pharmacies are encouraged to use these translations.

California SB 204 (2013)

With SB 204, California has reintroduced legislation that requires pharmacies to use the standard medication instructions that have been translated into non-English languages provided on the Board of Pharmacy’s website. This will provide LEP patients with prescription instructions that they will understand which helps increase patient compliance and reduce medical errors.

This bill was first introduced on February 8, 2013 at the SEN Business, Professions & Economic Development committee meeting. However, at that time the committee recommended opposing this bill as introduced.

New York Pharmacy Language Requirements

New York has pharmacy language requirements under an Attorney General’s agreement, through New York City legislation and now via a statewide SafeRx pharmacy language law.

New York City Pharmacy Language Law

In August 2009, the New York City Council passed the Language Access Pharmacies Act (LAPA). This law, technically called “Introductory Number 859-A,” was signed by Mayor Bloomberg on September 3, 2009. The law requires every chain pharmacy to provide free translation and interpretation of prescription medication Directions for Patients (SIGs), warning labels and patient information sheets (CMI) to each LEP individual. The bill stipulates that the chain pharmacy must translate medical instructions into the seven languages most commonly spoken by LEP individuals in New York City—Spanish, Chinese, Korean, Russian, Haitian Creole, Italian and Polish.

New York State Attorney General’s Agreement

In April 2009, then NY State Attorney General Andrew Cuomo signed an agreement with seven large pharmacy chains: Target, Walmart, Duane Reade, CVS, RiteAid, A&P, and Costco. These companies agreed to provide New York customers with prescription medication instructions in their primary language. Under the terms of these agreements, the companies will counsel all pharmacy customers about prescription information in their own language and provide written translations in 6 specific languages—Spanish, Chinese, Italian, Russian, Polish and French.

New York Statewide SafeRx Regulations

On March 30, 2012, New York passed comprehensive SafeRx legislation. The NY Statewide SafeRx regulations require every chain pharmacy to provide free, competent oral interpretation and written translation services of prescription drug labels, auxiliary warning labels and other written materials to limited English proficiency (LEP) patients. These language services must be provided immediately, although the language service provider does not need to be on the premises of the pharmacy. If a pharmacy offers language services to an LEP patient and the patient refuses, then the pharmacy is not required to provide language services.

Under NY SafeRx, pharmacies must provide their LEP customers whose primary language is one of the 4 primary languages specified (Chinese, Italian, Russian, Spanish) the translated versions of the following for all prescription drugs:

• Medication labels (Directions for Use of the Drug)
• Auxiliary Warning Labels
• Other written materials (for example Patient Education Sheets)

Also, under SafeRx, pharmacy staff who are not able to communicate adequately with an LEP individual in their primary language must use, free of charge to the customer, an interpreter, either in-store or over the phone, when:

• Offering prescription drug counseling
• Performing counseling with an individual about his or her prescription medications
• Soliciting information necessary to maintain a patient medication profile

New York’s statewide SafeRx legislation does not replace other existing New York pharmacy language requirements. In fact, SafeRx is clear that whichever is more strict supersedes, and cities with a population of over 100,000 residents are free to pass stricter SafeRx legislation.

SafeRx is technically already in force, however, under the NY State Education Department’s Board of Pharmacy it will not be fully implemented until June 15, 2013. SafeRx provisions for mail order pharmacies are expected to go into effect March 30, 2014.

To Summarize

This blog was just an overview of the pharmacy language laws in the US. The summary is that there are definite mandates for pharmacies to provide language services for limited English proficiency patients.

RxTran stands alone as the only provider of pharmacy language services to offer both written translation and verbal interpreting that meets all state and federal pharmacy language laws. RxTran offers pharmacies an online library of pre-translated prescription drug information (directions for use (SIGs), auxiliary warning labels and patient education sheets), which can be printed directly onto prescription labels or in supplemental forms, and distributed to LEP patients. RxTran also offers On-Demand Phone Interpreting that gives pharmacies 24/7 access to trained interpreters, enabling pharmacists to verbally communicate with LEP patients in seconds.

What pharmacy language requirements do you know about? Have you encountered limited English proficiency customers in your local pharmacy? Let us know in our comments section, and don’t forget to share this information with anyone you think may benefit from it.