Washington State House of Representatives Office of Program Research | BILL ANALYSIS |
Health Care & Wellness Committee |
HB 2586
This analysis was prepared by non-partisan legislative staff for the use of legislative members in their deliberations. This analysis is not a part of the legislation nor does it constitute a statement of legislative intent. |
Brief Description: Concerning graded dosage packs.
Sponsors: Representatives Caldier, Cody, Slatter, Harris and Rodne.
Brief Summary of Bill |
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Hearing Date: 1/23/18
Staff: Kim Weidenaar (786-7120).
Background:
The Washington State Pharmacy Quality Assurance Commission (Commission) regulates the practice of pharmacy and the distribution, manufacturing, and delivery of pharmaceuticals. A controlled substance is defined as a drug, substance, or immediate precursor included in Schedules I through V as set forth in federal or state laws, or federal or state board of pharmacy rules. The schedule a substance is placed in depends on its potential for abuse, whether there is a currently accepted medical use in treatment, and the safety of the substance and risk for dependence, as determined by the Commission. It is unlawful for any person to possess a controlled substance unless the substance was obtained pursuant to a valid prescription or order of a medical practitioner while acting in the course of his or her professional practice.
Prescription under the Washington Uniform Controlled Substances Act is defined as an order for controlled substances issued by a practitioner duly authorized by law or rule in Washington to prescribe controlled substances within the scope of his or her professional practice for a legitimate medical purpose.
A prescription for a controlled substance must include the following information:
date issued;
patient's name and contact information
practitioner's name, contact information, and federal Drug Enforcement Administration registration number;
drug name;
drug strength;
dosage;
quantity;
directions; and
signature of the prescriber.
Federal law requires controlled substances, in addition to many other drugs, to be packaged in child-resistant packaging. Certain unit-dose blister packaging that is used for prescription drugs can be made child-resistant through several ways including puncture-resistant and peel-push blisters.
Summary of Bill:
By July 1, 2019, the Pharmacy Quality Assurance Commission (Commission) must adopt rules outlining the schedule II and III oral narcotics that manufacturers must offer for sale in graded dosage packs. The Commission must determine a strength and dosage regimen for each narcotic it determines should be made available in graded dosage packs. The regimens must be made available in three, five, and seven days based upon the most commonly prescribed dosages and relevant prescribing guidelines. The rules must also designate the design of the packaging that is consumer-friendly and child-resistant. In adopting the rules, the Commission must consult prescribers and manufacturers.
Beginning January 1, 2020, drug manufacturers that sell, distributes, or dispenses narcotics the Commission determined should be made available in graded dosage packs must offer the graded dosage packs for sale. The packs must be in consumer-friendly and child-resistant packaging as required by Commission rules. The packs must clearly delineate the regimen the consumer should follow, indicating the date and time all doses should be consumed.
Health carriers may only charge enrollees one co-payment for the graded dosage pack.
Graded dosage pack is defined as a clearly delineated three, five, or seven day pharmaceutical regimen that may include multiple strengths of the same narcotic packed in a consumer-friendly, child-resistant form by the manufacturer.
Appropriation: None.
Fiscal Note: Available.
Effective Date: The bill takes effect 90 days after adjournment of the session in which the bill is passed.