Re-posting Washington's Notice of Public Comment Period

 

Accessible Labeling Standards Public Comment Period The Washington Department of Health filed a CR-102 Notice of Proposed Rulemaking amending a section of rule — WAC 246-945-015 Minimum Requirements for Dispensing Practitioners — and creating four new sections of rule: WACs 246-945-026 Accessible Prescription Information — Definitions, 246-945-027 Accessible Prescription Information, 246-945-028 Accessibility of Prescription Information for Visually Impaired or Print Disabled Individuals, and 246-945-029 Translation and Interpretation for Prescription Information for LEP Individuals. The CR-102 was filed on August 14, 2024 under WSR 24-17-046. The proposed rule requires that all dispensing practitioners and dispensing facilities in the state of Washington provide prescription information to the patient on the container in a format that can be accurately comprehended by the patient. The CR-102 form and the rule language may be viewed at the following link: CR-102 Proposed Rule Making – Prescription Drug Label Accessibility Standards Rule Language A public hearing for this proposed rulemaking will be held on October 4, 2024 at 9 a.m. Meeting information is below: Zoom # 871 4349 5001 and Labor & Industries Building, 7273 Linderson Way SW, Tumwater, WA 98501  Written comments on the proposed rule may be submitted on the department rules comment page or sent to Joshua Munroe, Rules and Legislative Consultant, at PharmacyRules@doh.wa.gov. There will also be an opportunity to deliver oral comments during the public hearing. We will continue accepting written comments until midnight on October 3, 2024. For those wishing to provide oral comment, the October 4 public hearing will be limited to two minutes per speaker to ensure as many participants as possible are able to provide comment. If you do not believe two minutes is sufficient, the commission encourages you to also provide written comment prior to the deadline of midnight on October 3, 2024. On October 4, the commission will only be taking public comment. During its regular business meeting October 11, the commission will be reviewing responses to the public comment and determining next steps. The commission is working to secure Spanish-language interpretation services for the public hearing. If you need additional accessibility services, please contact commission staff no later than September 20, 2024 at PharmacyRules@doh.wa.gov.

Model Bill Language

Here is an updated version of the Model Bill Language to reflect some ideas introduced in 2024 bills.

(1) A pharmacy shall notify each person to whom a prescription drug is dispensed that an accessible/translated prescription label is available to the person upon request at no additional cost.

(2) If a person informs the pharmacy that the person identifies as a person who is blind, low vision, otherwise print disabled, or limited English proficient the pharmacy shall provide to the person an accessible prescription label affixed to the bottle that is:

(a) Available to the person in a timely manner comparable to other patient wait time and lasting for at least the duration of the prescription; and

(b) Appropriate to the disability, preference and language of the person making the request through use of audible, large print, Braille or translated labels; and

(c) Conforms to the format specific best practices established by the United States Access Board and National CLAS Standards; and

(d) Contains all the label information required by state statute and federal law including cautions, warnings and any information available to sighted, English proficient individuals reading the printed label.

(3) A pharmacy shall ensure that the prescription label is compatible with the prescription reader if a reader is provided.

(4) The requirements of this section do not apply to prescription drugs both dispensed and administered by an institutional pharmacy.

(5) “Prescription reader” means a device that is designed to audibly convey the information contained on the label of a prescription drug.

(6) An "Institutional pharmacy" means a pharmacy that is part of or is operated in conjunction with any of the following health care facilities: hospital, ambulatory surgical facility, nursing home, residential care facility, freestanding rehabilitation facility, hospice care program, home and community-based services provider, residential facility for individuals with mental illness or developmental disabilities, or any similar health care facility.

(7) Appropriation and/or establishment of a grant program to assist independent pharmacies with the cost of implementing this bill.  

(8) The board of pharmacy shall promulgate regulations necessary to implement this section.

California AB1902 Heads to Governor's Desk

 

 California Bill Passes Both Chambers

AB1902 accessible prescription labeling bill has passed both the Assembly and the Senate and is heading to the Governor's desk for signature thanks to the efforts lead author Rep. Juan Alanis, coauthors Rep Megan Dahle, Dixon, Lackey and Mathis, and disability rights organizations including the California Council of the Blind.

AB1902 requires pharmacies to provide an accessible prescription label in audible, large print, or Braille formats to any one who informs the pharmacy that they are blind, have low vision or are otherwise print impaired.  

Labels must be available in a timely manner comparable to wait times of other patients and a label reader provided if necessary.  Labels must be affixed to the bottle unless it does not fit the container, in which case a supplemental document can be provided.  Pharmacies should conform to the best practices established by the US Access Board and the National Standards for Culturally and Linguistically Appropriate Services.

California is the third state to have both language access and accessible prescription labeling legislation, following Oregon and Nevada.