Report Title:

Prescription Drug Repository

Description:

Provides for a prescription drug repository to receive and dispense donated prescription drugs to needy persons. (SD2)

THE SENATE

S.B. NO.

2090

TWENTY-SECOND LEGISLATURE, 2004

S.D. 2

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. Section 328C-1, Hawaii Revised Statutes, is amended by adding five new definitions to be appropriately inserted and to read as follows:

""Health care provider" means an individual or organization 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.

"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.

"Repository" means:

(1) A charitable, religious, or nonprofit organization licensed pursuant to chapter 461-8.5; or

(2) A foreign medical aid mission group that distributes pharmaceuticals and healthcare supplies to needy persons abroad."

SECTION 2. Chapter 328C, Hawaii Revised Statutes, is amended by adding two new sections to be appropriately designated and to read as follows:

"§328C-   Donated drugs repository. (a) Drugs that meet the requirements of section 461-11(c) but are otherwise not appropriate for return-for-credit-and-reuse, may be donated to repository entities. Drugs may not be appropriate for return-for-credit-and-reuse due to, but not limited to the following:

(1) Product valuation is less than the handling fee;

(2) Market demand makes reuse implausible by the expiration or discard by date; or

(3) Product prescription number and patient identifier are not discernable, therefore crediting to the payer is not possible.

(b) Donations to repository entities shall not require crediting the original payer including medicaid.

(c) Drugs donated to a repository shall have the patient's name removed or redacted from the product including the label.

§328C-   Record keeping. All dispensed and billed drugs subject to return-for-credit-and-reuse or all drugs subject to donation to repository entities, shall be recorded subject to audit. Records shall be retained by both the institutional facility or supervised living group and the pharmacy for five years and shall include the following information, at a minimum:

(1) The name and address of the donor site;

(2) The prescription number, unless the donation is to a repository entity;

(3) The name of the drug and manufacturer or the national drug code;

(4) The quantity of the drug;

(5) The expiration or discard by date;

(6) The date the drug was sent to the pharmacy, repository entity, or any other agent or final disposition;

(7) The name of the pharmacy, repository entity, or any other agent and a notion of the final disposition, such as returned-for-credit-and-reuse, donated, disposed, or destroyed; and

(8) The initials of the person making the entry.

The facility record shall be copied and used as a manifest for the recipient pharmacy or repository. The manifest and products shall be reviewed by the pharmacy prior to accepting or receiving all products to ensure that products are returnable for credit. Any discrepancies shall be noted and corrected. The accepted manifest shall be retained for five years. Records may be electronically composed, stored, and maintained and must be retrievable and printable for audit purposes. Returned product manifests shall be reconcilable with credits to payers."

SECTION 3. Chapter 461, Hawaii Revised Statutes, is amended by adding a new section to be appropriately designated and to read as follows:

"§461-   Credit and reimbursement for handling returned drugs. (a) Drugs returned to the dispensing pharmacy that have been previously billed shall be credited to the payer for the quantity of drugs returned not including the original dispensing fee and subject to a handling fee. The handling fee shall not exceed three hundred fifty per cent of the medicaid professional dispensing fee. The handling fee shall not reduce the credit amount below zero. Dispensed and billed drugs with a valuation below the handling fee may not be subject to return-for-credit-and-reuse and shall not be returned to the pharmacy. Drugs that have been refused on delivery and are returned to the pharmacy shall be credited to the payer in full and shall not be subject to a handling fee.

(b) The pharmacy may negotiate reasonable reimbursement to the institutional facility or supervised living group for proper storage and record keeping of returned drugs from the handling fee.

(c) Returned drugs may be sold on prescription."

SECTION 5. Section 461-11, Hawaii Revised Statutes, is amended to read as follows:

§461-11 Duties of registered pharmacist. (a) Every registered pharmacist in charge of a pharmacy shall comply with all laws and rules. The pharmacist shall be responsible for the management of the pharmacy and every activity thereof which is subject to this chapter shall be under the pharmacist's complete control.

(b) All registered pharmacists shall notify the board of changes of business address within ten days.

(c) Prescription drugs previously dispensed or distributed by a pharmacist may be returned to and redispensed or redistributed by the pharmacist if the prescription drug:

(1) Is in its dispensed multiple dose container or unopened, untampered single user unit;

(2) Has remained at all times under the control or direction, including periods in transit by any carrier for hire or person or entity hired solely to transport prescription drugs, of a person trained and knowledgeable in the storage of drugs in institutional facilities or supervised living groups using the services of a consultant pharmacist;

(3) Is not adulterated or misbranded;

(4) Has been stored under conditions meeting the United States pharmacopoeia standards; and

(5) Is returned and redispensed or redistributed before the expiration date on the multiple dose container unit.

Nothing in this subsection shall be construed to relieve any person from any requirement prescribed by law with respect to drugs included or may be included within the classification of controlled substances, as defined in the applicable federal and state laws."

SECTION 6. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.

SECTION 7. This Act shall take effect on July 1, 2004.