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Know Your Rights
Source: Make the Road New York
Subject: Health Justice & Access
Type: Pubs & Reports

Rx for Safety: SafeRx Recommendations for Clear and Accessible Prescription Medication


Every New Yorker should understand his or her prescription medication labels and should have safe access to prescription medications.  Make the Road New York (MRNY), Center for Popular Democracy (CPD) and New York Lawyers for the Public Interest (NYLPI) have championed the issue of safe access to prescription medications in New York State by advocating for the passage of legislation designed to address patient safety.  As a result of our efforts, the efforts of Governor Andrew Cuomo’s Medicaid Redesign Team (MRT), and the New York State Legislature, pharmacy language access and label standardization legislation (SafeRx) was passed in the New York State Budget in April 2012.  This is the first state law of its kind in the United States, propelling New York as a leader in protecting consumers. 

While enactment of SafeRx has been a tremendous victory, the New York State Board of Pharmacy (SBOP), comprised of pharmacy industry representatives, is tasked with developing regulations to implement SafeRx before it goes into full effect.  In response, we are producing this report to make recommendations that balance consumer interests with industry interests, and that are based on medical literature and industry best practices.  In Part One, our report describes what is required under SafeRx and includes answers to frequently asked questions about SafeRx.  In Part Two we discuss our SafeRx recommendations.  These recommendations are as follows:

(1)   Pharmacy Primary Languages

  • Apply a straightforward approach that requires translation in the top 6 or 7 non-English languages spoken throughout the state, or
  • Use Census and other relevant data to determine the top languages spoken by 1% or more of the limited English proficient (“LEP”) population in a given area, rather than 1% of the general population.

(2)   Notification

  • Use a standard message regarding patients’ rights and translate that message in multiple languages (e.g. “I Speak” flash cards in multiple languages).
  • Require pharmacies to include a Pharmacy Customer Bill of Rights for Language Services on their websites.
  • Require pharmacies to engage in broader outreach to inform LEP consumers of their rights to language assistance services and the availability of such services. 

(3)   Mail Order Pharmacies

  • Commit to an accelerated study and review of existing systems and processes in place at mail order pharmacies, including efforts already underway to improve language services delivery. Provide meaningful inclusion of the perspective of LEP consumers and patients in any study that is conducted.

(4)   Liability

  • Institute a plan to monitor covered pharmacies’ compliance with the law. 

(5)   Waiver

  • Eliminate the waiver option. Consult with the Office of Civil Rights for Region II of the US Department of Health and Human Services (HHS OCR) as well as the Federal Coordination and Compliance Section of the Department of Justice (DOJ) to ensure that state policies and procedures comply with federal law.

(6)   Standardization

  • Include some of the United States Pharmacopeial standards as a starting point to create more comprehensive label standardization regulations.  Include input of consumer groups, advocates for special populations, pharmacists, physicians, other health care professionals, and other key stakeholders.   

(7)   Prescription Pads

  •  Require that a box be added to the official paper prescription pad similar to the current dispense as written (DAW) box that a prescriber can initial or check if a patient is LEP. Similarly require a check box for prescribers using electronic prescription forms.
  • Add a line immediately adjacent to this box for the prescriber to write in the patient’s preferred language, or use a drop-down menu for prescribers using electronic prescription forms.

Incorporating the recommendations in this report will ensure that the SafeRx regulations operate as intended, where millions of consumers in New York have access to patient-centered medication instructions and language assistance services.

Please download the report for full details.