BILL REQ. #: S-1156.2
| State of Washington | 63rd Legislature | 2013 Regular Session |
READ FIRST TIME 02/06/13.
AN ACT Relating to medication access for the uninsured; adding a new chapter to Title 69 RCW; and providing an effective date.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
NEW SECTION. Sec. 1 The definitions in this section apply
throughout this chapter unless the context clearly requires otherwise.
(1) "Department" means the department of health.
(2) "Drug manufacturer" means a facility licensed by the board of
pharmacy under chapter 18.64 RCW that engages in the manufacture of
drugs or devices.
(3) "Drug wholesaler" means a facility licensed by the board of
pharmacy under chapter 18.64 RCW that buys drugs or devices for resale
and distribution to corporations, individuals, or entities other than
consumers.
(4) "Medical facility" means a hospital, pharmacy, nursing home,
boarding home, adult family home, or medical clinic where the
prescription drugs are under the control of a practitioner.
(5) "Person" means an individual, corporation, business trust,
estate, trust, partnership, association, joint venture, government,
governmental subdivision or agency, or any other legal or commercial
entity.
(6) "Pharmacist" means a person licensed by the board of pharmacy
under chapter 18.64 RCW to practice pharmacy.
(7) "Pharmacy" means a facility licensed by the board of pharmacy
under chapter 18.64 RCW in which the practice of pharmacy is conducted.
(8) "Practitioner" has the same meaning as in RCW 69.41.010.
(9) "Prescribing practitioner" means a person authorized to issue
orders or prescriptions for legend drugs as listed in RCW 69.41.030.
(10) "Prescription drugs" has the same meaning as "legend drugs" as
defined in RCW 69.41.010. The term includes cancer drugs and
antirejection drugs. The term does not include controlled substances.
(11) "Supplies" means the supplies necessary to administer
prescription drugs that are donated under the prescription drug
redistribution program.
NEW SECTION. Sec. 2 Any practitioner, pharmacist, medical
facility, drug manufacturer, or drug wholesaler may donate prescription
drugs and supplies to a pharmacy for redistribution without
compensation or the expectation of compensation to individuals who meet
the prioritization criteria established in section 3 of this act.
Donations of prescription drugs and supplies may be made on the
premises of a pharmacy that elects to participate in the provisions of
this chapter. A pharmacy that receives prescription drugs or supplies
may distribute the prescription drugs or supplies to another pharmacy,
pharmacist, or prescribing practitioner for use pursuant to the
program.
NEW SECTION. Sec. 3 Pharmacies, pharmacists, and prescribing
practitioners that elect to dispense donated prescription drugs and
supplies under this chapter shall give priority to individuals who are
uninsured and at or below two hundred 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,
those prescription drugs and supplies may be dispensed to other
individuals expressing need.
NEW SECTION. Sec. 4 (1) Prescription drugs or supplies may be
accepted and dispensed under this chapter if all of the following
conditions are met:
(a) The prescription drug is in:
(i) Its original sealed and tamper evident packaging; or
(ii) An opened package if it contains single unit doses that remain
intact;
(b) The prescription drug bears an expiration date that is more
than six months after the date the prescription drug was donated;
(c) The prescription drug or supplies are inspected before the
prescription drug or supplies are dispensed by a pharmacist employed by
or under contract with the pharmacy, and the pharmacist determines that
the prescription drug or supplies are not adulterated or misbranded;
(d) The prescription drug or supplies are prescribed by a
practitioner for use by an eligible individual and are dispensed by a
pharmacist; and
(e) Any other safety precautions established by the department have
been satisfied.
(2)(a) If a person who donates prescription drugs or supplies to a
pharmacy under this chapter receives a notice that the donated
prescription drugs or supplies have been recalled, the person shall
notify the pharmacy of the recall.
(b) If a pharmacy that receives and distributes donated
prescription drugs to another pharmacy, pharmacist, or prescribing
practitioner under this chapter receives notice that the donated
prescription drugs or supplies have been recalled, the pharmacy shall
notify the other pharmacy, pharmacist, or prescribing practitioner of
the recall.
(c) If a person collecting or distributing donated prescription
drugs or supplies under this chapter receives a recall notice from the
drug manufacturer or the federal food and drug administration for
donated prescription drugs or supplies, the person shall immediately
remove all recalled medications from stock and comply with the
instructions in the recall notice.
(3) Prescription drugs and supplies donated under this chapter may
not be resold.
(4) Prescription drugs and supplies dispensed under this chapter
shall not be eligible for reimbursement under the medical assistance
program.
NEW SECTION. Sec. 5 (1) The department must adopt rules
establishing forms and procedures to: Reasonably verify eligibility
and prioritize patients seeking to receive donated prescription drugs
and supplies; and inform a person receiving prescription drugs donated
under this program that the prescription drugs have been donated for
the purposes of redistribution. A patient's eligibility may be
determined by a form signed by the patient certifying that the patient
is uninsured and at or below two hundred percent of the federal poverty
level.
(2) The department may establish any other rules necessary to
implement this chapter.
NEW SECTION. Sec. 6 (1) Except as provided in subsection (2) of
this section, a practitioner, pharmacist, medical facility, drug
manufacturer, or drug wholesaler who donates, accepts, or dispenses
prescription drugs or supplies for redistribution under this chapter is
not subject to criminal prosecution, professional discipline, or civil
liability for damages for injury, death, or loss to a person or
property for matters relating to the donation, acceptance, or
dispensing of the prescription drug, including liability for failure to
transfer or communicate product or consumer information or the
expiration date of the donated prescription drugs or supplies.
(2) The protections provided under subsection (1) of this section
do not apply if the practitioner, pharmacist, medical facility, drug
manufacturer, or drug wholesaler commits acts or omissions of this
chapter that constitute gross negligence. For a person distributing
donated prescription drugs under this chapter, gross negligence is not
shown if a person:
(a) Meets all requirements of section 5 of this act and any
applicable rules relating to the return or exchange of prescription
drugs or supplies adopted by the board of pharmacy;
(b) Maintains records of any prescription drugs and supplies
donated to the pharmacy and subsequently dispensed by the pharmacy; and
(c) Identifies himself or herself to the public as participating in
the prescription drug redistribution program created by this chapter.
NEW SECTION. Sec. 7 Access to prescription drugs and supplies
under this chapter is subject to availability. Nothing in this chapter
establishes an entitlement to receive prescription drugs and supplies
through the program.
NEW SECTION. Sec. 8 Nothing in this chapter restricts the use of
samples by a practitioner during the course of the practitioner's
duties at a medical facility or pharmacy.
NEW SECTION. Sec. 9 Nothing in this chapter authorizes the
resale of prescription drugs by any person.
NEW SECTION. Sec. 10 Sections 1 through 9 of this act constitute
a new chapter in Title
NEW SECTION. Sec. 11 This act takes effect July 1, 2014.