HB 1852 — Concerning language requirements for prescription drug labels.

ENGROSSEDH-2015.1 SUBSTITUTE HOUSE BILL 1852 State of Washington 67th Legislature 2022 Regular Session By House Health Care & Wellness (originally sponsored by Representatives Thai, Cody, Gregerson, Macri, Santos, Slatter, Valdez, Pollet, and Riccelli)Riccelli READPrefiled FIRST01/07/22. TIME 02/02/22.

Read first time 01/10/22.

Referred to Committee on Health Care & Wellness.

amending RCW 18.64.390;

(1) ByBeginning JulyJanuary 1, 2024,2023, upon the commissionrequest of a patient, patient's representative, or prescriber, a pharmacy or nonresident pharmacy licensed under this chapter shall adoptprovide rulestranslated establishingdirections for use and the requirementsprescription fordrug's side effects, if the translationlanguage requested is one of prescriptionthe druglanguages labelsselected andby prescriptionthe information.commission in subsection (2) of this section.

(a)The Attranslated aversion minimum,and English language version of the rulesdirections for use and side effects must require:appear on the prescription container or label.

(i)(2) The translationcommission ofshall determine the directionslanguages for usewhich andtranslation anyis auxiliaryrequired. warnings that would otherwise be included on the prescription drug label;

(ii)(a) The translatedcommission versionmust andconsider Englishthe languagepercent version of the directionspopulation forin useWashington appearthat onspeaks the prescriptionlanguage, containerthat orpopulation's label;access to health care, and principles of equity when determining which languages to provide translations for and must choose 15 languages.

and (iii) A pharmacy or nonresident pharmacy provide the translated directions for use, auxiliary warnings, and any other information required by the commission in rules if the language is one selected by the commission upon the request of a patient, patient's representative, or prescriber.

1 ESHBHB 1852 (b) RulesEvery adoptedfive underyears thisthe sectioncommission must establishreassess and update the following:languages as needed based upon the factors listed in (a) of this subsection.

(i)(3) The languagescommission forshall: which translation is required;

(ii)(a) TheMake elementstranslations of adirections prescriptionfor druguse labeland orcommon otherside information,effects suchavailable asin informationthe sheetslanguages orthe sidecommission effects,determines thatunder mustsubsection be(2) translated;of this section;

(iii)and The(b) pharmaciesDevelop andsignage settingsto thatnotify the public of the availability or the translation requirementsservice applythat to;pharmacies must post.

(iv)(4) The processcommission formay procuringcontract with a state or providingnonstate entity to complete the translations;translations required under this section.

(v)(5) WhenA a pharmacy or nonresident pharmacy mustis not required to provide translated directions for use and side effects beyond the translatedlanguages prescriptionand information;translations that the commission has made available.

and(6) (vi)A Anypharmacy signagemay thatprovide aits pharmacyown musttranslated postdirections tofor notifyuse consumersand ofside effects to comply with the availabilityrequirements of translatedthis prescriptionsection. information.

(2)Nothing Whenin adoptingthis rulessection establishingshall thebe languagesconstrued forto whichprohibit translationa ispharmacy required,from theproviding commissiontranslated shalldirections choosefor atuse leastor 15side languageseffects andbeyond aimthe to provide translations in all languages spokenthe bycommission athas leastselected fiveor percentbeyond of the statedirections populationfor use or 1,000side peopleeffects inthat Washingtonthe withcommission limitedhas Englishmade proficiencyavailable andin must:translated form.

(a)(7) ConsultThe withpharmacy theor Washingtonnonresident statepharmacy officeshall ofbe equityresponsible andonly for the governor'saccuracy interagencyof councilthe onEnglish healthlanguage disparities;directions for use and side effects provided to the patient.

(b)A Considerpharmacy, nonresident pharmacy, or pharmacist may not be held liable for relying in good faith on the percenttranslated ofdirections for use or side effects provided by the populationcommission inor Washingtonfor thatproviding speakstranslated directions beyond those the language,commission thathas population'smade accessavailable toif healththe care,translation andwas principlesprovided ofin equity;good faith.

and (c) At least every five years, reassess, update, and increase the number of languages as needed based upon the factors listed in this subsection.

(3) The commission may contract with a state or nonstate entity to implement and administer this section.

(4) Nothing in this section shall be construed to prohibit a pharmacy or nonresident pharmacy from providing translated directions for use, auxiliary warnings, side effects, or other prescription information beyond the languages selected by the commission or to a greater extent than required by the commission.

(5) 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 commission in subsection (1) of this section if the pharmacy, nonresident pharmacy, or pharmacist contracted with the third party in good faith, and the pharmacy, nonresident p.

2 ESHB 1852 pharmacy, or pharmacist was not negligent with regard to the alleged misconduct of the third party.

(6) The commission shall provide pharmacies and nonresident pharmacies a minimum of 120 days from the date rules are adopted under subsection (1) of this section to comply with the rules.

(7) This section applies only to outpatient prescriptions dispensed for home use that are intended for human use.

(8) This section does not apply to:

(a) Prepackaged emergency medications as provided in RCW 70.41.480;

and (b) Opioid overdose reversal medication distributed pursuant to RCW 70.41.485 and 71.24.594.

(9) By July 1, 2024, the commission shall adopt rules establishing other accessibility requirements for individuals who are blind, low vision, or otherwise print disabled for prescription drug labels and prescription information.

(10) The commission may adopt any rules necessary to implement and administer this section.

(11) By July 1, 2023, the commission shall report to the relevant policy and fiscal committees of the legislature on the rule-making progress, including the selection of languages and the process for procuring or providing the translations.

(12) For purposes of this section, an "auxiliary warning" or "advisory label" is a cautionary warning label added onto a dispensed prescription drug label by a pharmacist in addition to the required prescription drug label to provide extra information to the patient on the safe administration, use, and storage of the prescription.

Sec.

2.

RCW 18.64.390 and 2013 c 19 s 23 are each amended to read as follows:

(1) The commission may deny, revoke, or suspend a nonresident pharmacy license or impose a fine not to exceed ((one thousand dollars)) $1,000 per violation for failure to comply with any requirement of RCW 18.64.350 through 18.64.400 and section 1 of this act.

(2) The commission may deny, revoke, or suspend a nonresident pharmacy license or impose a fine not to exceed ((one thousand dollars)) $1,000 per violation for conduct that causes serious bodily or psychological injury to a resident of this state if the secretary has referred the matter to the regulatory or licensing agency in the p.

3 ESHB 1852 state in which the pharmacy is located and that regulatory or licensing agency fails to initiate an investigation within ((forty- five)) 45 days of the referral under this subsection or fails to make a determination on the referral.

42 ESHBHB 1852