Brief Summary of Substitute Bill

Allows pharmacies to accept donations of unused and unopened prescription drugs and supplies from practitioners, pharmacists, medical facilities, drug manufacturers, and drug wholesalers for redistribution to individuals that are uninsured and low-income, or individuals otherwise in need.
Requires persons dispensing donated prescription drugs and supplies to inspect donated prescription drugs and supplies prior to redistribution and meet other program-related requirements.
Establishes legal immunity for dispensing facilities and pharmaceutical manufacturers.

Background:

Over 35 states have prescription drug redistribution laws. These laws allow certain entities, such as medical facilities or consumers, to return unopened and unused prescriptions to a designated collection entity for redistribution to uninsured or low-income individuals. States with redistribution laws have reported total cost savings to recipients ranging from $15,000 to over $750,000 per year.

Washington does not prohibit pharmacies from redistributing unused and unopened prescription drugs. Board of Pharmacy rules allow pharmacies and medical facilities to accept prescription drugs for return under certain circumstances; however, Washington does not provide pharmacies and medical facilities operating redistribution programs with the legal protections that are characteristic of prescription drug redistribution laws.

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Summary of Substitute Bill:

When distributing donated prescription drugs and supplies, pharmacies, pharmacists, and prescribing practitioners shall give preference to priority individuals. Priority individuals are those that are uninsured and low-income; however, pharmacies, pharmacists, and prescribing practitioners may distribute donated prescription drugs and supplies to other individuals in need if priority individuals are not in need of an available drug.

Pharmacies may accept and dispense donated prescription drugs and supplies only if they meet certain quality control conditions:

The donated prescription drug must be in its original sealed and tamper evident packaging or in an intact single unit dose package.
The expiration date must be more than six months after the donation date.
A pharmacist must inspect the donated prescription drug or supply and find that it is not adulterated or misbranded.
The prescription drug was prescribed by a practitioner to an eligible individual and dispensed by a pharmacist.

Any person that is eligible to donate, collect, or distribute donated prescription drugs and supplies, and does so exercising reasonable care, is eligible for immunity from criminal prosecution, professional discipline, or civil liability. The immunity applies as long as a person meets the quality control conditions; maintains records of donated prescription drugs and supplies; and notifies the public of the facility's participation in dispensing donated prescription drugs and supplies.

Manufacturers of prescription drugs that are collected and redistributed under this program are immune from criminal prosecution and civil damages associated with redistribution.

Substitute Bill Compared to Original Bill:

Entities that may donate prescription drugs and supplies is expanded to include drug wholesalers and drug manufacturers. Entities that may distribute donated prescription drugs and supplies is amended.

Rulemaking is required to establish patient eligibility requirements and procedures for identifying patient eligibility. Provisions are removed requiring that distributing entities establish eligibility requirements and procedures.

Changes are made to recall notice provisions, immunity provisions, and new definitions are added.

Staff Summary of Public Testimony:

(In support) Prescription drug affordability is an issue and this bill is an important step forward in tough economic times.

(In support with concerns) The Legislature should find ways to reduce drug costs, reduce drug waste, and also protect patients. It is important that the bill has criteria for protecting the integrity of drugs; requirements to track sources of drugs, lot numbers and expiration dates; storage and handling requirements; pharmacist evaluation requirements; and provisions to assess the accuracy of the drug being collected and that the correct usage directions are provided to recipients. The bill should allow distributors to charge a dispensing or administration fee and should provide more guidance for determining patient eligibility. The bill could do more to allow others to donate drugs, such as allow patients (individuals) to donate prescription drugs and supplies.

(Opposed) None.

Persons Testifying: (In support) Representative Jinkins, prime sponsor; Mary Clogston, AARP; and Seth Dawson, Washington Association for Substance Abuse Prevention.

(In support with concerns) Steven Saxe, Department of Health; Dedi Hitchens, Washington State Pharmacy Association; and Scott Sigman, Aging Services of Washington.