2005 -- H 5107 SUBSTITUTE A

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LC00295/SUB A

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2005

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A N A C T

RELATING TO HEALTH AND SAFETY

     Introduced By: Representatives Sullivan, Corvese, Moura, McNamara, and Costantino

     Date Introduced: January 18, 2005

     Referred To: House Corporations

It is enacted by the General Assembly as follows:

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     SECTION 1. Title 23 of the General Laws entitled "Health and Safety" is hereby

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amended by adding thereto the following chapter:

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     CHAPTER 25.4

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UTILIZATION OF UNUSED PRESCRIPTION DRUGS ACT

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     23-25.4-1. Title. -- This act may be cited as the "Utilization of Unused Prescription

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Drugs Act."

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     23-25.4-2. Legislative purpose. -- The general assembly has determined that the high

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cost of prescription drugs is a burden on the uninsured who may forego the drugs they need or

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take only partial doses which can ultimately increase health costs. The general assembly has also

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determined that many nursing facilities and assisted living residences destroy quantities of unused

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but viable prescription medications when residents pass away or when medications otherwise are

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no longer needed by the resident. In an effort to improve the quality, efficiency and utilization of

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the state's health care system, the general assembly hereby establishes a voluntary statewide pilot

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program allowing nursing facilities and assisted living residences to transfer from their facilities

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unused prescription drugs to authorized participating pharmacies for distribution to medically

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indigent Rhode Island residents.

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     23-25.4-3. Definitions. – For the purposes of this chapter:

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     (a) "Assisted living residence" has the same meaning as such term is defined in section

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23-17.4-2 and the regulations promulgated thereunder.

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     (b) "Blister packages' means multi-dose containers of a specific medication repackaged

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by the pharmacy in accordance with section 13.7 of the regulations promulgated under chapter

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19.1 of title 5 and intended for a specific patient.

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     (c) "Cancer drugs" means any of several drugs that control or kill neoplastic cells,

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commonly referred to as "cancer-fighting chemotherapy" to destroy cancer cells.

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     (d) "Health care prescriber" means any of the following persons licensed and authorized

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to prescribe drugs or to provide medical, dental, or other health-related diagnoses, care of

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treatment within the scope of their professional license:

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     (i) A physician holding a current license to practice medicine pursuant to chapter 37 of

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title 5;

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     (ii) A certified registered nurse practitioner licensed pursuant to chapter 34 of title 5;

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     (iii) A physician assistant licensed pursuant to chapter 54 of title 5;

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     (iv) A dentist licensed pursuant to chapter 31.1 of title 5;

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     (v) An optometrist licensed pursuant to chapter 35 of title 5; and

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     (vi) A pharmacist licensed pursuant to chapter 19.1 of title 5.

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     (vii) A nurse – midwife licensed pursuant to section 23-13-9 of chapter 13 of title 23; and

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     (viii) A psychiatric and mental health clinical nurse specialist licensed pursuant to chapter

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34 of title 5.

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     (e) "Medically indigent" means a person eligible to receive Medicaid or Medicare or a

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person who has no health insurance and who otherwise lacks reasonable means to purchase

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prescribed drugs.

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     (f) "Charitable clinic" means an organized ambulatory care facility licensed pursuant to

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chapter 17 of title 23 organized as a nonprofit corporation pursuant to section 7-6-2 that:

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     (1) Holds a valid exemption from federal income taxation issued pursuant to Section

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501(a) of the Internal Revenue Code (26 U.S.C., Section 501(1);

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     (2) Is listed as an exempt organization under 501(c) of the Internal Revenue Code (26

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U.S.C., Section 501(c);

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      (3) Has a licensed outpatient pharmacy located at the organized ambulatory care or a

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contract with a retail pharmacy.

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     (g) "Prescription drug" means a drug which may be dispensed only upon prescription by

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a health care prescriber authorized by his or her licensing authority and which is approved for

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safety and effectiveness as a prescription drug under Section 505 or 507 of the Federal Food,

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Drug and Cosmetic Act (52 Stat. 1040 (1938), 21 U.S.C.A., Section 301).

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     (h) "Unit-dose container" is one that is designed to hold a quantity of a drug intended for

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use as a single dose and used promptly after the container is opened. The immediate container,

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and/or the outer container or protective packaging shall be designed to show evidence of any

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tampering with the contents. Each individual container shall be fully identifiable containing a

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single dose of a single entity and shall protect the integrity of the dosage form. Labeling shall be

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in accordance with USP standards compendia and federal and state law and shall include the

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identity, quantity, and strength of the product, name of the manufacturer, and lot number and

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expiration date of the article.

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     23-25.4-4. Program established. -- (a) The department of health and the board of

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pharmacy shall jointly develop and implement a pilot program consistent with public health and

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safety through which unused prescription drugs, other than prescription drugs defined as

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controlled substances in section 21-28-1.02, may be transferred from nursing facilities or assisted

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living residences that centrally store prescription drugs and are licensed at the M1 licensure level

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by the department of health to pharmacies authorized for the purpose of re-dispensing the

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medication to Rhode Island residents who are medically indigent.

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      (b) The pilot program shall conform to the requirements established in rules promulgated

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by the state department of health and the board of pharmacy. The pilot program shall remain in

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effect until January 1, 2007.

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      (c) The state department of health and the board of pharmacy shall review and evaluate

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the pilot program and shall submit a report and any recommendations to the governor, the speaker

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of the house of representatives, and the president of the senate on or before January 1, 2007.

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      (d) Beginning January 1, 2006, the department of health and the board of pharmacy shall

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implement statewide a program consistent with public health and safety through which unused

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prescription drugs, other than prescription drugs defined as controlled substances in section 21-

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28-1.02, may be transferred from nursing facilities of assisted living residences or to pharmacies

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authorized by the board for the purpose of re-dispensing the unused prescription drugs to Rhode

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Island residents who are medically indigent.

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      (e) The department of health and the board of pharmacy shall promulgate rules and

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establish procedures necessary to implement the program established pursuant to this chapter.

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      (f) The board of pharmacy shall provide technical assistance to entities who may wish to

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participate in the program.

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     23-25.4-5. Criteria. -- The following criteria shall be used in soliciting and accepting

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unused prescription drugs for use pursuant to this chapter:

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     (a) Nursing facilities and assisted living residences that have entered into an agreement to

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participate with an eligible charitable clinic shall solicit residents to participate in the program by

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requiring the residents to sign a statement whereby their excess and otherwise eligible unused

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prescription drugs shall be donated to a specific pharmacy associated with an eligible charitable

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clinic for the purpose of re-dispensing to eligible recipients of such prescription drugs.

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Participation in this program by residents of participating nursing facilities and assisted living

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residences shall be strictly voluntary.

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     (b) Only prescription drugs in their original sealed multi-dose blister packages, unit dose

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containers or perforated blister packages shall be accepted and re-dispensed;

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     (c) Expired prescription drugs shall not be accepted;

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     (d) A prescription drug shall not be accepted or re-dispensed if the pharmacist accepting

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or re-dispensing the drug, in his or her judgment has reason to believe that the drug is adulterated

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mislabeled, or has been improperly stored;

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     (e) No controlled substances shall be accepted; and

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     (f) Subject to the limitation specified in this section, unused prescription drugs dispensed

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for purposes of a medical assistance program may be accepted and re-dispensed pursuant to this

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chapter.

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     23-25.4-6. Participation. -- (a) Participation in the "Utilization of Unused Prescription

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Drugs Act" by individual residents of any assisted living residence or nursing facility,

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pharmacies, nursing facilities, assisted living residences, charitable clinics or prescription drug

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manufacturers shall be voluntary. Nothing in this chapter shall require any resident of any

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assisted living residence or nursing facility, pharmacy, pharmacists, charitable clinic or

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prescription drug manufacturer to participate in the program.

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     (b) A pharmacy operating in conjunction with a charitable clinic that meets the eligibility

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requirements established in this chapter may:

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     (1) Re-dispense prescription drugs donated pursuant to this chapter to persons who are

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medically indigent residents of Rhode Island.

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     (c) A pharmacy operating in conjunction with a charitable clinic wherein both meet the

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eligibility requirements established and authorized by this chapter and that accepts donated

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prescription drugs shall:

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     (1) Comply with all applicable federal and state laws relating to the storage, distribution,

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and dispensing of prescription drugs;

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     (2) Inspect all prescription drugs prior to re-dispensing the prescription drugs to

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determine that such drugs are not adulterated; and

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     (3) Re-dispense prescription drugs only pursuant to a valid prescription issued by a

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health care prescriber.

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     (d) Prescription drugs donated pursuant to this chapter shall not be resold.

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     23-25.4-7. Liability. -- (a) For matters related only to the lawful donation, acceptance, or

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re-dispensing of prescription drugs under this chapter, the following persons and entities, in

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compliance with the criteria set forth in this chapter, in the absence of bad faith or gross

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negligence, shall not be subject to criminal or civil liability for injury other than death, or loss to

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person or property, or professional disciplinary action:

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     (1) The board of pharmacy;

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     (2) Any resident of a nursing facility or assisted living residence who agrees to donate

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unused prescription drugs, or his/her next of kin or legal guardian;

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     (3) The department of mental health, retardation and hospitals;

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     (4) Any prescription drug manufacturer, governmental entity, nursing facility, or assisted

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living residence who participates in the program for the reuse of prescription drugs pursuant to

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this chapter;

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     (5) Any prescription drug manufacturer or its representative that directly donates

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prescription drugs in professional samples to a charitable clinic or a pharmacy pursuant to this

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chapter;

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     (6) Any health care prescriber or pharmacy that accepts or dispenses operating in

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conjunction with a charitable clinic that accepts or re-dispenses prescription drugs pursuant to this

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chapter; and

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     (7) Any pharmacy or pharmacist operating in conjunction with a charitable clinic, or

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other state-contracted pharmacy that employs a health care professional who accepts or can

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legally dispense prescription drugs pursuant to this chapter.

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     (b) For matters related to the donation, acceptance, or dispensing of a prescription drug

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manufactured by the prescription drug manufacturer that is donated by any entity pursuant to this

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chapter, a prescription drug manufacturer shall not, in the absence of bad faith be subject to

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criminal or civil liability for injury death, or loss to person or property including, but not limited

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to, liability for failure to transfer or communicate product or consumer information or the

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expiration date of the donated prescription drug.

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     23-25.4-8. Rules. -- (a) The board of pharmacy shall promulgate emergency rules by

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December 1, 2005, to implement the provisions of this chapter. Permanent rules shall be

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promulgated pursuant to the administrative procedures act. Such rules shall include:

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     (1) Eligibility criteria for pharmacies and charitable clinics authorized to receive and

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dispense donated prescription drugs pursuant to this chapter;

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     (2) Establishment of a formulary which shall include all prescription drugs approved by

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the federal Food and Drug Administration;

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     (3) Standards and procedures for transfer, acceptance, safe storage, security, and

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dispensing of donated prescription drugs;

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     (4) A process for seeking input from the state department of health in establishing

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provisions which affect nursing homes and assisted living residences;

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     (5) A process for seeking input form the department of mental health, retardation and

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hospitals in establishing provisions which affect mental heath and substance abuse clients;

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     (6) Standards and procedures for inspecting donated prescription drugs to ensure that the

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drugs are in compliance with the provisions of this chapter and to ensure that, in the professional

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judgment of the pharmacist, the medications meet all federal and state standards for product

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integrity;

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     (7) Procedures for destruction of medications that are donated which are controlled

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substances;

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     (8) Procedures for verifying whether the pharmacy and responsible pharmacist

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participating in the program are licensed and in good standing with the board of pharmacy;

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     (9) Establishment of standards for acceptance of unused prescription medications from

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assisted living residences; and

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     (10) Any other standards and procedures the board of pharmacy deems appropriate or

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necessary to implement the provisions of this chapter.

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     (b) In accordance with the rules and procedures of the program established pursuant to

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this section, a resident of a nursing facility or assisted living residence, or the representative or

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guardian of a resident may donate unused prescription medications, other than prescription drugs

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defined as controlled dangerous substances, for dispensation to medically indigent persons.

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     23-25.4-9. Prohibitions. -- It shall be unlawful for any person, firm or corporation to:

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     (a) Forge or increase the quantity of drug in any prescription, or to present a prescription

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bearing forged, fictitious or altered information or to possess any drug secured by such forged,

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fictitious or altered prescription;

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     (b) Sell, offer for sale, barter or give away any unused quantity of drugs obtained by

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prescription, except through a program pursuant to this chapter or as otherwise provided by the

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board of pharmacy;

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     (c) Sell, offer for sale, barter or give away any drugs damaged by fire, water, or other

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causes without first obtaining the written approval of the board of pharmacy or the state

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department of health;

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     (d) Enter into any arrangement whereby prescription orders are received, or prescriptions

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delivered at a place other than the pharmacy in which they are compounded and dispensed.

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However, nothing in this paragraph shall prevent a pharmacist or an employee of the pharmacy

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from personally receiving a prescription or delivering a legally filled prescription at a residence,

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office or place of employment of the patient for whom the prescription was written. Nothing in

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this paragraph shall prevent veterinary prescription drugs from being shipped directly from a

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wholesaler or distributor to a client; provided, such drugs may be dispensed only on prescription

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of a licensed veterinarian and only when an existing veterinary-client-patient relationship exists;

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     (e) Sell, offer for sale or barter or buy any professional samples except through a program

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established pursuant to this chapter. For purpose of this subsection, "professional samples"

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means complimentary drugs packaged in accordance with federal and state statutes and

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regulations and provided to a licensed practitioner free of charge by manufacturers or distributor

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for the purpose of being distributed free of charge in such package by the licensed practitioner to

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a patient;

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     (f) Refuse to permit or otherwise prevent members of the board of pharmacy or such

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representative thereof from entering and inspecting any and all places, including premises,

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equipment, contents, and records, where drugs, medicine, chemicals or poisons are stored, sold,

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vended, given away, compounded, dispensed or manufactured; or

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     (g) Possess dangerous drugs without a valid prescription or a valid license to possess

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such drugs.

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     SECTION 2. This act shall take effect upon passage.

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LC00295/SUB A

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N A C T

RELATING TO HEALTH AND SAFETY

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     This act would create the Utilization of Unused Prescriptions Medications Act which

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would authorize the department of health and the board of pharmacy to create and implement a

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voluntary statewide pilot program allowing nursing homes, assisted living centers and

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prescription drug manufacturers to transfer from their facilities unused prescription medications

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to authorized participating pharmacies for distribution to medically indigent Rhode Island

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residents. This act would establish standards for authorizing participants under this chapter,

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would authorize the board of pharmacy to promulgate program rules and establish criteria for

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accepting unused prescription drugs for use under the chapter. This act would also establish the

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exclusion of liabilities for participants in the program and determine prohibited criminal acts

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under the chapter.

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     This act would take effect upon passage.

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LC00295/SUB

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