Report Title:

Prescription Drug Repository

Description:

Provides for a prescription drug repository to receive and dispense donated prescription drugs to needy persons. Repeal date 6/30/06. (SB2090 HD1)

THE SENATE

S.B. NO.

2090

TWENTY-SECOND LEGISLATURE, 2004

S.D. 2

STATE OF HAWAII

H.D. 1


 

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

RETURN-FOR-CREDIT-AND-REUSE OF PRESCRIPTION DRUGS

§ -1 Definitions. For the purposes of this chapter:

"Institutional facility" means any facility using the services of an on-site pharmacy or an off-site consulting pharmacy contractor, at which medications are administered by personnel of the facility. "Institutional facility" includes but is not limited to a:

(1) Hospital;

(2) Convalescent home;

(3) Skilled nursing facility;

(4) Intermediate care facility;

(5) Extended care facility;

(6) Mental institution;

(7) Rehabilitation center;

(8) Health maintenance organization;

(9) Psychiatric center;

(10) Mental retardation center;

(11) Penal institution;

(12) Hospice facility; or

(13) Supervised living group.

"Pharmacy" means a place of business operating as a pharmacy as permitted under chapter 461.

"Return-for-credit-and-reuse of prescription drugs" means the process by which prescription drugs dispensed by the dispensing pharmacy of an institutional facility are safely returned to that pharmacy and redispensed for purposes of patient or resident care, or both, which process includes the appropriate crediting of the cost of returned drugs to the payer less handling fees to providers where applicable, recordkeeping, and the return of the drugs to pharmacy stock for redispensing.

§ -2 Returning-for-credit-and-reuse of prescription drugs. Previously dispensed prescription drugs may be returned to the dispensing pharmacy for credit to the payer and subsequent reuse as provided by this chapter; provided that:

(1) The prescription drugs meet the requirements of

461-   ;

(2) Appropriate credits and handling fees are applied;

(3) Appropriate recordkeeping provides for documentation of receipt, transfer, and credit;

(4) The prescription drugs are returned only to the original dispensing pharmacy; and

(5) Prescription drugs from individual members of the public shall not be accepted for reuse.

Prescription drugs are not appropriate for return-for-credit-and-reuse and shall not be returned for credit under this chapter under conditions which include, but are not limited to the following:

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

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

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

Prescription drugs that are not returnable for credit may be donated as provided in chapter 328C.

§ -3 Credit and reimbursement for handling returned drugs. (a) Prescription drugs that have been refused on delivery and are returned to the dispensing pharmacy shall be credited to the payer in full and shall not be subject to a handling fee.

(b) If prescription drugs returned to the dispensing pharmacy have been previously billed to the payer, the payer shall be credited for the quantity of drugs returned not including the original dispensing fee less any handling fee. The handling fee shall not exceed three hundred fifty per cent of the Hawaii 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 shall not be returned for credit under this chapter.

(c) The pharmacy may negotiate with the institutional facility to include reimbursement for the proper storage and recordkeeping of returned drugs in the handling fee.

(d) Returned prescription drugs may be sold by prescription subject to subsections (a), (b), and (c).

§ -4 Recordkeeping. (a) The institutional facility shall keep records of all previously dispensed prescription drugs returned to the institutional facility. Records shall be retained for five years and shall include at least the following:

(1) The name and address of the institutional facility;

(2) The prescription number, or other patient or payer identifier;

(3) The name and strength of the drug;

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

(5) The quantity of the drug;

(6) The expiration date or use by date;

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

(8) The name of the pharmacy, repository entity, or any other agent that received or is to receive the drug for final disposition and a description of the disposition, such as returned-for-credit-and-reuse, donated, disposed, or destroyed; and

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

(b) Records of drugs to be returned-for-credit-and-reuse shall be copied by the institutional facility and used as a manifest for products sent to the recipient pharmacy. 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 noting any corrections shall be retained for five years by both the institutional facility and the pharmacy. Records may be electronically composed, stored, and maintained in a form retrievable and printable for audit purposes. Returned product manifests shall be reconcilable with credits to payers.

(c) All institutional facility records required by this chapter shall be subject to audit by agents of the director of human services or director of health."

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) Prescription drugs that meet the requirements of section 461- but are otherwise not appropriate for return-for-credit-and-reuse as defined in section -2, may be donated to repository entities. Prescription drugs from individual members of the public shall not be accepted for donation.

(b) Donations to repository entities shall be made without credit to the original payer, including medicaid, for the cost of the drugs.

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

§328C-     Recordkeeping. (a) All previously dispensed prescription drugs subject to donation to repository entities shall be recorded by the institutional facility. Records shall be retained by the institutional facility for five years and shall include the following information:

(1) The name and address of the donating institutional facility;

(2) The name and strength of the drug;

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

(4) The quantity of the drug;

(5) The expiration or use by date of the drug;

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

(7) The name of the pharmacy, repository entity, or any other agent that received or is to receive the drug for final disposition and a description of the disposition, such as returned-for-credit-and-reuse, donated, disposed, or destroyed; and

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

(b) Records of drugs subject to donation to repository entities shall be copied and used as a manifest for the products sent to the recipient repository entity.

(c) All institutional facility records shall be subject to audit by agents of the director of human services or director of health."

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

"§461-     Return of prescription drugs. Prescription drugs previously dispensed or distributed by a pharmacy for administration to patients in an institutional facility by personnel of the institutional facility 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 trainsit 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 the institutional facility or the pharmacy;

(3) Is not adulterated or misbranded;

(4) Has been stored under conditions meeting United States Pharmacopoeia standards;

(5) Is returned and redispensed or redistributed before the expiration date or use by date on the multiple dose container or single user unit; and

(6) Has not been in the possession of an individual member of the public.

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

SECTION 4. Section 328C-1, Hawaii Revised Statutes, is amended by adding four new definitions to be appropriately inserted and to read as follows:

""Pharmaceutical company" means any company that manufactures pharmaceuticals and health care supplies.

"Pharmacy" has the meaning provided in section 461-1.

"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 the order of a practitioner, as defined in section 461-1.

"Repository" means:

(1) A charitable, religious, or nonprofit organization as defined in section 328C-1, licensed as a wholesale prescription drug distributor 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 5. Section 461-1, Hawaii Revised Statutes, is amended by adding a new definition to be appropriately inserted and to read as follows:

""Institutional facility" means any facility using the services of an on-site pharmacy or an off-site consulting pharmacy contractor, at which medications are administered by personnel of the facility. "Institutional facility" includes but is not limited to a:

(1) Hospital;

(2) Convalescent home;

(3) Skilled nursing facility;

(4) Intermediate care facility;

(5) Extended care facility;

(6) Mental institution;

(7) Rehabilitation center;

(8) Health maintenance organization;

(9) Psychiatric center;

(10) Mental retardation center;

(11) Penal institution;

(12) Hospice facility; or

(13) Supervised living group."

SECTION 6. Section 328C-2, Hawaii Revised Statutes, is amended to read as follows:

"§328C-2 Exceptions to liability. (a) A charitable, religious, or nonprofit organization which in good faith receives pharmaceuticals or health care supplies, apparently fit for human consumption or external use, and distributes them to needy persons at no charge, shall not be liable for any civil damages or criminal penalties resulting from the use of the pharmaceuticals or health care supplies donated to needy persons unless an injury or illness results to those needy persons as a result of that organization’s gross negligence or wanton acts or omissions.

(b) Any pharmacy, wholesale prescription drug distributor, pharmaceutical company, institutional facility, or practitioner that in good faith provides pharmaceuticals, including previously dispensed prescription drugs, and health care supplies to needy persons without remuneration or expectation of remuneration, shall be exempt from civil liability for injuries and damages resulting from their acts or omissions in providing pharmaceuticals and health care supplies, except for gross negligence, or wanton acts or omissions on the part of the pharmacy, wholesale prescription drug distributor, pharmaceutical company, institutional facility, or practitioner.

(c) Any donated, previously dispensed, prescription drug:

(1) Shall be in its dispensed, unopened, tamper-evident single user unit;

(2) Shall have remained at all times in the control of a person trained and knowledgeable in the storage and administration of drugs in institutional facilities;

(3) Shall not have been adulterated, misbranded, or stored under conditions contrary to standards established by the United States Pharmacopoeia or the product manufacturer; and

(4) Shall be used before the expiration date on the unit.

(d) This section shall not relieve any organization from any other duty imposed upon it by law for the inspection of donated pharmaceuticals or health care supplies or for any provisions regarding the handling of those products, or relieve any health care provider from liability arising out of the prescription of such pharmaceuticals or health care supplies.

[(e) For purposes of this section:

"Needy person" means any natural person who lacks the means to obtain adequate or proper pharmaceuticals or health care supplies as determined by a practitioner at a Hawaii qualified health center established under section 346-41.5, to be in need of service.

"Pharmaceuticals and health care supplies" means any medicine (prescription or nonprescription, excluding all controlled substances listed in chapter 329) or health care supplies such as soap, personal sanitary products, baby formula, dietary supplement, health care aids such as thermometers, surgical gloves, or bandages, or any other item that is customarily fit for human consumption or external use, before the expiration date stamped on the product, if any.

"Pharmaceutical company" means any company that manufactures pharmaceuticals and health care supplies.

"Pharmacy" is as defined in chapter 461.]"

SECTION 7. The department of health shall submit a report to the legislature no later than twenty days prior to the regular session of 2006 reporting:

(1) Difficulties with the implementation and operation of the prescription drug repository program, if any;

(2) Potential for expansion to include drugs donated by private individuals; and

(3) Suggested legislation.

SECTION 8. Statutory material to be repealed is bracketed and stricken. New statutory material is underscored.

SECTION 9. This Act shall take effect on July 1, 2004, and shall be repealed on July 1, 2006.