Written Translation Services
Massive online, growing database of foreign language drug instructions to print directly onto prescription labels:
- Directions for Use (SIGs)
- Auxiliary Warning Labels
- Patient Education Sheets
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New York State Pharmacy Translation Requirements
A few States, as well as New York City, have passed comprehensive pharmacy language access laws to ensure that community pharmacies provide free translation and interpreting services to their customers with limited English proficiency (LEP).
Below we describe informally and briefly the gist of some specific requirements enacted in New York State. (See legal disclaimer, below).
What are the NY State SafeRx Regulations?
The 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 offer language services.
“Every covered pharmacy shall provide free, competent oral interpretation services and translation services of prescription medication labels, warning labels and other written material to each LEP individual filling a prescription at such covered pharmacy, unless the LEP individual is offered and refuses such services or the medication label, warning labels and other written materials have already been translated into the language spoken by the LEP individual.”
(Written) Translation Requirements for Pharmacies
INFORMATION REQUIRED TO BE TRANSLATED
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 all prescription drug:
- Medication labels (Directions for Use of the Drug)
- Warning Labels
- Other written materials
(Oral) Interpreting Requirements for Pharmacies
WHICH (ORAL) INTERPRETING SERVICES ARE REQUIRED FOR LEP INDIVIDUALS
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:
- Counseling an individual about his or her prescription medications
- Soliciting information necessary to maintain a patient medication profile
- Offering prescription drug counseling
When Was SafeRx Pharmacy Translation Legislation Passed?
Governor Cuomo’s Executive Budget for fiscal year 2012-2013 incorporated the Accessible Prescription Labels (SafeRx) proposal. SafeRx legislation was included in the final New York state budget that was passed and approved on March 30, 2012. The final enacted budget moved SafeRx into the Education, Labor and Family Assistance bill (A.9057-D; S.6257-E)
The State Education Department and the Department of Health were required to issue regulations mandating chain pharmacy stores to provide oral interpretation services and written translation services to customers with limited English proficiency who are filling prescriptions.
SafeRx became law in New York one year after it was formally signed, meaning that it went into effect on March 30, 2013. SafeRx has no expiration and will not change unless the legislature decides on a rollback at some future point.
Pharmacy Language Requirement Text of the 2012 NY State Budget
On March 20, 2013 the State Education Department (SED) released rule making activities for the implementation of SafeRx calling it “Interpretation and Translation for Prescription Drugs, Standardized Labeling and Patient-Centered Data Elements for Medications (I.D. No. EDU-12-13-00014-P).”
What is the Implementation Schedule for SafeRx?
The NY State Education Department (SED) has released its proposal that would add two sections (63.11 and 63.12) to Title 8 NYCRR. These are currently rule making proposals with no hearing(s) scheduled. Public comments were accepted until May 3, 2013.
SafeRx became effective March 30, 2013. Under the SED’s emergency provision implementation of SafeRx is scheduled for July 3, 2013.
Text of State Education Board Implementation Proposed Ruling for SafeRx
Who Is Considered To Be Limited English Proficiency (LEP)
Under New York’s SafeRx legislation a person is deemed to be LEP or have limited English proficiency if they self identify as being unable to communicate with English or if it is apparent that the person cannot communicate using English at a level to adequately understand health related information.
"Limited English proficient individual" or "LEP individual" means an individual who identifies as being, or is evidently, unable to speak, read or write English at a level that permits such individual to understand health-related and pharmaceutical information communicated in English.
What Languages Require Translation?
The law states that languages spoken by 1% or more of the population as determined by the US census for each region will require written translation and oral interpreting. A maximum limit of 7 languages is set for each region.
"Pharmacy primary languages" shall mean those languages spoken by one percent or more of the population, as determined by the U.S. Census, for each region, as established by regulations promulgated pursuant to this section, provided, however, that the regulations shall not require translation or competent oral interpretation of more than seven languages in any region.
The NY State Education Department in their proposed regulations treats all of the New York state as one region. This results in establishing four primary languages statewide:
- Chinese—There has been no clarification as to which versions of spoken or written Chinese are being considered
Pharmacies Required to Provide Language Services Under SafeRx?
Under this law, all pharmacy chains with 8 or more stores under a common trade symbol or corporate entity are required to provide language services. In New York, of the total number of pharmacies, slightly over 40% (of the 5,044 registered pharmacies) would fall under the scope of SafeRx.
Any pharmacy that is part of a group of eight or more pharmacies, located within New York state and owned by the same corporate entity. For purposes of this section, "corporate entity" shall include related subsidiaries, affiliates, successors, or assignees doing business as or operating under a common name or trading symbol.
Pharmacy Language Services Notification Requirement
SafeRx mandates that every covered pharmacy is required to “conspicuously” display a notice in the pharmacy primary languages that notifies patients of the available interpreting and translation services.
The notice must include the following statement in all covered primary languages:
“Point to your language. Language assistance will be provided at no cost to you.”
Additional requirements for the notification are:
- Notice must be in 20 point bold face, Arial font
- Notice must be in a color that sharply contrasts the background color of the sign
- Each statement must be enclosed in a box
- There must be at least ¼ inch clear space between adjacent boxes
- All primary language notifications must be printed on one sign
- Notice must be displayed conspicuously at or adjacent to each counter where prescriptions are dropped off, where prescriptions are picked up, and near every cash register where payment is received for prescription drugs.
Pharmacy Translation and Interpretation Liability
Under SafeRx a particular pharmacy is not liable if it has used language services in good faith and errors occur.
“Covered pharmacies shall not be liable for injuries resulting from the actions of third-party contractors taken pursuant to and within the scope of the contract with the covered pharmacy as long as the covered pharmacy entered into such contract reasonably and in good faith to comply with this section, and was not negligent with regard to the alleged misconduct of the third-party contractor.”
Penalties for not complying with SafeRx
The State Education Department regulates pharmacies in NY. People can submit non-compliance complaints to the NY State Education Department.
Provisions for Waivers of SafeRx
The NY State Education Department rules do allow for waivers of SafeRx on an individual pharmacy. To obtain a waiver the burden of substantiating the validity of a request for waiver falls on the applicant pharmacy. Here are the specifics regarding SafeRx waivers:
- Each application is specific to an individual pharmacy (regardless of common ownership under a chain).
- Applicant must be able to clearly document the “financial or physical constraints, threat to other services provided, or other circumstances upon which the request is based.”
- No waiver will be granted if the pharmacy cannot show that complying with SafeRx would be “unnecessarily burdensome when compared to the need for the translation and competent oral interpretation services.”
- Pharmacies applying for waivers must identify other sources of competent interpreting and translation services within a reasonable distance.
- If the waiver is approved, pharmacies must post a notice, in the pharmacy primary languages, informing LEP individuals of alternative sources.
- Any waivers granted will last on year and “may be renewed upon approval of a new waiver application by the department.”
Does SafeRx Negate Other New York Pharmacy Language Requirements?
SafeRx clearly states that it does not diminish or impair any pharmacy from providing language services beyond its requirements. Further, it does not preempt any contrary local laws ordinances, unless there is a consent decree, or judicial settlement, judgment or order. A city with a population over 100,000 may retain or promulgate laws imposing additional or stricter pharmacy language service requirements.
“In accordance with Part V of Chapter 57 of the Laws of 2012, the provisions of this section shall preempt any contrary local law or ordinance; provided, however, that cities with a population of 100,000 or more may retain or promulgate such local laws or ordinances imposing additional or stricter requirements relating to interpretation services or translation services in pharmacies. Nothing in this section shall diminish or impair any requirement that any pharmacy or pharmacist provide any language assistance, interpretation, or translation under any applicable federal or state law, local law or ordinance (unless preempted by this section), consent decree, or judicial settlement, judgment or order.”
Mail Order Pharmacies Under New York’s SafeRx Legislation
This legislation defines a Mail Order Pharmacy as any entity that provides most of its prescriptions through US Postal or other delivery system.
"Mail order pharmacy" shall mean a pharmacy that dispenses most of its prescriptions through the United States postal service or other delivery system.
If a mail order pharmacy is located out of state, but still services NY residents, that mail order pharmacy must be compliant with SafeRx regulations. New York State regulates mail order pharmacies as they would with any company that is headquartered out of state, but still does business in NY.
The State BOP must develop regulations in consultation with the Department of Health establishing pharmacy translation and interpreting requirements over the next year, and these regulations are set to go into effect March 30, 2014. Estimates are that the NY State Education Department will present the mail order pharmacy language regulations in early 2014.
“The commissioner, in consultation with the commissioner of health, shall promulgate regulations requiring that mail order pharmacies conducting business in the state provide free, competent oral interpretation services and translation services to persons filling a prescription through such mail order pharmacies whom are identified as LEP individuals…
The commissioner, in consultation with the commissioner of health, shall provide a report on implementation, utilization, unanticipated problems, and corrective actions undertaken and planned to the temporary president of the senate and the speaker of the assembly no later than two years after the effective date of this section.”
For More Information
On this site we informally and briefly describe the gist of some laws and regulations enacted or being considered in various jurisdictions. These descriptions are not intended to be a complete or exhaustive presentation of the laws and regulations. They are not intended, nor should be relied upon, as a source of legal advice. Please consult qualified counsel for any questions regarding interpretation of any laws and regulations mentioned on this site.