Report Title:

Prescription Drug Repository Program

Description:

Establishes the prescription drug repository program to receive and dispense donated prescription drugs to needy persons.

THE SENATE

S.B. NO.

2090

TWENTY-SECOND LEGISLATURE, 2004

 

STATE OF HAWAII

 


 

A BILL FOR AN ACT

 

relating to a prescription drug repository program.

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

SECTION 1. The Hawaii Revised Statutes is amended by adding a new chapter to be appropriately designated and to read as follows:

"Chapter

PRESCRIPTION drug repository program

§   -1 Definitions. As used in this chapter:

"Health care provider" means an individual licensed, certified, or otherwise authorized or permitted by law to provide health care in the ordinary course of business or practice of a profession.

"Needy person" means a resident of this State who lacks the means to obtain adequate or proper prescription drugs, as determined by a practitioner at a Hawaii qualified health center, established under section 346-41.5, or who meets qualifications established by the board of pharmacy pursuant to section     -5.

"Nonprofit clinic" means a charitable, nonprofit organization that is exempt from income taxation under chapter 235, that provides prescription drugs to needy persons at no cost or low cost, and may provide other health care services.

"Prescription drug" means:

(1) Any drug required by federal or state statutes, regulations, or rules to be dispensed only upon prescription, including finished dosage forms and active ingredients subject to section 328-16 or section 503(b) of the Federal Food, Drug, and Cosmetic Act; or

(2) Any drug product compounded or prepared pursuant to a practitioner's order.

"Program" means the prescription drug repository program established by this chapter.

§   -2 Prescription drug repository program; establishment; donated prescription drug requirements. (a) The state board of pharmacy shall establish a prescription drug repository program to receive and distribute prescription drugs that are donated for the purpose of being provided to needy persons.

(b) Any donated prescription drug in its original sealed and tamper-evident unit dose packaging may be accepted and dispensed. The packaging shall be unopened, except that prescription drugs packaged in single unit doses may be accepted and dispensed when the outside packaging is opened if the single unit dose packaging is undisturbed.

(c) A prescription drug donated by an individual bearing an expiration date that is less than six months from the date the drug is donated shall not be accepted or dispensed.

(d) A prescription drug shall not be accepted or dispensed if there is reason to believe that it is adulterated as described in section 328-14. Subject to the limitation specified in this chapter, unused prescription drugs dispensed for purposes of the medicaid program may be accepted and distributed under the prescription drug repository program.

§   -3 Donation of prescription drugs. (a) Any person, including a drug manufacturer, or any health care provider may donate prescription drugs to the drug repository program. The prescription drugs shall be donated at a pharmacy, hospital, or nonprofit clinic that elects to participate in the prescription drug repository program and that meets criteria for participation in the program established by rules adopted by the state board of pharmacy. Participation in the program by pharmacies, hospitals, and nonprofit clinics is voluntary.

(b) A pharmacy, hospital, or nonprofit clinic eligible to participate in the program shall distribute prescription drugs donated under this section to needy persons who are residents of this State and who meet any additional eligibility standards established in rules adopted by the board. A prescription drug shall be distributed only pursuant to a prescription issued by a licensed health care provider who is authorized to prescribe drugs. A pharmacy, hospital, or nonprofit clinic that accepts donated prescription drugs shall comply with all applicable federal and state laws dealing with storage and distribution of dangerous prescription drugs and shall inspect all prescription drugs prior to distributing them to determine that they are not adulterated.

(c) The pharmacy, hospital, or nonprofit clinic may charge individuals receiving donated prescription drugs a handling fee established in accordance with rules adopted by the board. Prescription drugs donated to the program may not be resold.

§   -4 Exceptions to liability. Exceptions to liability for the receipt and dispensing of prescription drugs under the prescription drug repository program shall be as established for donations of pharmaceuticals and health care supplies in section 328C-2.

§   -5 Rules. (a) In consultation with the director of health, the state board of pharmacy shall adopt rules governing the prescription drug repository program that establish all of the following:

(1) Eligibility criteria for pharmacies, hospitals, and nonprofit clinics to receive and dispense donated prescription drugs under the program;

(2) Standards and procedures for accepting, safely storing, and dispensing donated prescription drugs;

(3) Standards and procedures for inspecting donated prescription drugs to determine that the original unit dose packaging is sealed and tamper-evident and that the drugs are unadulterated, safe, and suitable for dispensing;

(4) Eligibility standards based on economic need for individuals to receive donated prescription drugs;

(5) A means, such as an identification card, by which an individual who is eligible to receive donated prescription drugs may demonstrate eligibility to the pharmacy, hospital, or nonprofit clinic dispensing the donated prescription drugs;

(6) A form that an individual receiving a donated prescription drug from the program shall sign before receiving the drug to confirm that the individual understands the immunity provisions of the prescription drug repository program;

(7) A formula to determine the amount of the handling fee that pharmacies, hospitals, and nonprofit clinics may charge to donated prescription drug recipients under the program to cover restocking and dispensing costs;

(b) In addition, for prescription drugs donated to the prescription drug repository program by individuals, the rules shall provide for:

(1) A list of prescription drugs, arranged either by category or by individual drug, that the program will accept from individuals;

(2) A list of prescription drugs, arranged either by category or by individual drug, that the program will not accept from individuals. The list must include a statement as to why the drug is ineligible for donation;

(3) A form each donor must sign stating that the donor is the owner of the prescription drugs and intends to voluntarily donate them to the repository.

(c) In addition, for prescription drugs donated to the repository by health care facilities or health care providers, the rules shall provide for:

(1) A list of prescription drugs, arranged either by category or by individual drug, that the program will accept from health care facilities or health care providers;

(2) A list of drugs, arranged either by category or by individual drug, that the repository will not accept from health care facilities or health care providers. The list must include a statement as to why the drug is ineligible for donation.

(d) The rules may include any other standards and procedures the board considers appropriate.

(e) The rules shall be adopted in accordance with chapter 91."

SECTION 2. This Act shall take effect on July 1, 2004.

INTRODUCED BY:

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