SENATE BILL REPORT

SSB 5148

As Amended by House, April 9, 2013

Title: An act relating to medication access for the uninsured.

Brief Description: Allowing for redistribution of medications under certain conditions.

Sponsors: Senate Committee on Health Care (originally sponsored by Senators Keiser, Becker, Cleveland, Conway, Frockt, Parlette, Rolfes, Kohl-Welles, Schlicher and Kline).

Brief History:

Committee Activity: Health Care: 1/31/13, 2/05/13 [DPS].

Passed Senate: 2/26/13, 49-0.Passed House: 4/09/13, 84-10.

Majority Report: That Substitute Senate Bill No. 5148 be substituted therefor, and the substitute bill do pass.

Signed by Senators Becker, Chair; Dammeier, Vice Chair; Keiser, Ranking Member; Bailey, Cleveland, Ericksen, Parlette and Schlicher.

Staff: Kathleen Buchli (786-7488)

Background: Thirty-nine states have enacted laws to create prescription drug recycling, repository, or redistribution programs for unused medication. In general, drug redistribution programs allow the return of prescription drugs in single-use or sealed packaging from state programs, nursing homes, and other medical facilities. The medicines are then redistributed for use to needy residents who cannot afford to purchase their prescribed drugs. The scope of prescription drug programs varies by state and may include the following provisions: direct the financial terms of the donations or regulate resale; assure purity, safety, and freshness of the products; restrict the donation of expired drugs; prohibit the donation of controlled substances; require a state-licensed pharmacist or pharmacy to be part of the verification and distribution process; require patients to possess a valid prescription for the drugs they receive; limit donations to cancer drugs; limit donations to those within long-term care facilities; or limit program participation to correctional facilities.

Summary of Substitute Bill: Any health care practitioner, pharmacist, medical facility, drug manufacturer, or drug wholesaler may donate prescription drugs and supplies to a pharmacy for redistribution to individuals who are uninsured and are at or below 200 percent of the federal poverty level. If an uninsured and low-income individual has not been identified as in need of available prescription drugs and supplies, other individuals expressing need may receive those drugs. Participation by a pharmacy is voluntary. A pharmacy that receives prescription drugs or supplies may distribute these to another pharmacy, pharmacist, or prescribing practitioner for redistribution.

Prescription drugs and supplies may be accepted and dispensed by participating pharmacies if the prescription drug is in its original, sealed, and tamper-evident packaging, or in an opened package if the single unit doses remain intact; the prescription drug bears an expiration date that is more than six months after the date the prescription drug was donated; the prescription drug or supplies are inspected before they are dispensed, and they are determined to not be adulterated or misbranded; the prescription drug is dispensed by a pharmacist for the use of a person holding a prescription for those drugs or supplies; and other safety precautions adopted by the Department of Health (DOH) are satisfied. Any donor who receives notice of a recall relating to donated prescription drugs or supplies must notify the pharmacy of the recall; recalled medications may not be distributed.

Practitioners, pharmacists, medical facilities, drug manufacturers, and drug wholesalers who donate, accept, or dispense prescription drugs or supplies for redistribution are not subject to criminal prosecution, professional discipline, or civil liability for damages relating to the donation, acceptance, or dispensing of the prescription drug. This immunity does not apply if the entity commits acts or omissions that constitute gross negligence. To be eligible for this immunity, an individual who distributes donated prescription drugs must be in compliance with this Act, maintain records of donated drugs and supplies, and inform the public of the individual's participation in the program.

Appropriation: None.

Fiscal Note: Available.

Committee/Commission/Task Force Created: No.

Effective Date: The bill takes effect on July 1, 2014.

Staff Summary of Public Testimony on Original Bill: PRO: This bill addresses a need to properly dispose of unused medicine and to provide access for those people who are unable to afford their prescription medicines. We support including an informed consent requirement for the recipients of donated medications.

Persons Testifying: PRO: Leslie Emerick, Home Care Assn. of WA, WA State Hospice, Palliative Care Organization.

House Amendment(s): Drugs and supplies donated under the program are not eligible for reimbursement for the item nor the dispensing fee under any public or private program. Drugs may not be accepted or distributed if the federal Food and Drug Administration determines that they may only be dispensed to patients registered with the drug's manufacturer. Immunity for failure to transmit information on the expiration date of the donated item is available to the drug manufacturer, rather than all program participants.