The Pharmacy Quality Assurance Commission (Pharmacy Commission) regulates the practice of pharmacy, and the distribution, manufacturing, and delivery of pharmaceuticals within and into the state.
State law requires that a prescription container's label must include the dispensing pharmacy's name and address, the prescription number, the prescriber's name and directions, the medication's name and strength, the patient's name, the date, and the expiration date. The identification of the licensed pharmacist responsible for each dispensing of medication must either be recorded in the pharmacy's record system or on the prescription label. A violation of these requirements is a misdemeanor offense.
A nonresident pharmacy is a pharmacy located outside of Washington that ships, mails, or delivers, in any manner, except when delivered in person to an individual, controlled substances, legend drugs, or devices into the state. Nonresident pharmacies must be licensed by the Department of Health.
The United States Food and Drug Administration (FDA) has found that at least 60 million Americans age 4 and over speak a language other than English at home, and seven percent of Americans do not speak English at all. In 2014, FDA created a language access plan that is organized around ten elements, which includes written translations and notification of the availability of language assistance at no cost. FDA determined that vital documents and critical consumer information from the agency will be translated into six other most common spoken languages in the United States in addition to English and Spanish. Those six languages are French, German, Korean, Mandarin Chinese, Tagalog, and Vietnamese.
By July 1, 2024, the Pharmacy Commission must adopt rules establishing the requirements for the translation of prescription drug labels and prescription information. At a minimum, the rules must require:
The rules must establish:
When selecting the languages for the translations, the Pharmacy Commission must select at least 15 languages and aim to provide translations in all languages spoken by at least 5 percent of the state population or 1,000 people in Washington with limited English proficiency. The Pharmacy Commission must:
The Pharmacy Commission may contract with a state or nonstate entity to implement and administer these requirements. The Pharmacy Commission must provide pharmacies and nonresident pharmacies a minimum of 120 days from the date rules are adopted to comply with the rules. The Pharmacy Commission may deny, revoke, or suspend a nonresident pharmacy license or impose a fine not greater than $1,000 per violation for failure to comply with the requirements.
These requirements apply only to outpatient prescriptions dispensed for home use that are intended for home use. These requirements do not apply to prepackaged emergency medications and opioid overdose reversal medications distributed pursuant to statutory requirements for hospital emergency departments and certain behavioral health facilities.
A pharmacy or nonresident pharmacy is not prohibited from providing its own translations or providing translations beyond what is required in rule.
A pharmacy, nonresident pharmacy, or pharmacist may not be held liable for good faith reliance on translated prescription information provided by or through a third party in compliance with the rules adopted by the Pharmacy Commission if the pharmacy, nonresident pharmacy, or pharmacist contracted with the third party in good faith, and the pharmacy, nonresident pharmacy, or pharmacist was not negligent with regard to the alleged misconduct of the third party.
By July 1, 2023, the Pharmacy Commission must report to the relevant policy and fiscal committees of the Legislature on the rulemaking progress, including the selection of languages and the process for procuring or providing the translations.
By July 1, 2024, the Pharmacy Commission must adopt rules establishing other accessibility requirements for individuals who are blind, low vision, or otherwise print-disabled for prescription drug labels and prescription information.
An auxiliary warning or advisory label is a cautionary warning label added onto a dispensed prescription label by a pharmacist in addition to the required prescription label to provide extra information to the patient on the safe administration, use, and storage of the prescription.
PRO: The bill must ensure that translation is provided upon request, translation must appear on the label, and translation services must be available for at least 15 languages. The lack of any of these elements would lead to ineffective rules that would not change the status quo. The goal is to improve patient safety and while limiting undue burden on pharmacies. We live in a technological age where so much is possible and the ability to provide a prescription label in the patient's preferred language is long overdue.
CON: This bill is unnecessary. There are pharmacies already providing free translation to patients right now. The Pharmacy Commission has already started the rulemaking process to address this issue. There are other states who have worked collaboratively to create a solution that works for both large and small pharmacies while meeting the needs of the community. We respectfully request the committee hold the bill and allow the Pharmacy Commission to proceed forward.