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STATE OF RHODE ISLAND
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IN GENERAL ASSEMBLY
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JANUARY SESSION, A.D. 2013
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____________
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A N A C T
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RELATING TO HEALTH AND SAFETY - THE RETURN OR EXCHANGE OF DRUGS ACT
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Introduced By: Representatives DeSimone, Palangio, Slater, and Palumbo
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Date Introduced: January 31, 2013
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Referred To: House Health, Education & Welfare
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It is enacted by the General Assembly as follows:
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1-1
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SECTION 1. Chapter 23-25.4 of the General Laws entitled "Utilization of Unused
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1-2
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Prescription Drugs Act" is hereby repealed in its entirety.
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1-3
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CHAPTER 23-25.4
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Utilization of Unused Prescription Drugs Act
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23-25.4-1. Short title. -- This act may be cited as the "Utilization of Unused Prescription
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1-6
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Drugs Act."
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1-7
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23-25.4-2. Legislative purpose. -- The general assembly has determined that the high
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1-8
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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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1-9
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take only partial doses which can ultimately increase health costs. The general assembly has also
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1-10
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determined that many nursing facilities and assisted living residences destroy quantities of unused
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1-11
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but viable prescription medications when residents pass away or when medications otherwise are
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1-12
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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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1-13
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the state's health care system, the general assembly hereby establishes a voluntary statewide pilot
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1-14
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program allowing nursing facilities and assisted living residences to transfer from their facilities
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1-15
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unused prescription drugs to authorized participating pharmacies for distribution to medically
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1-16
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indigent Rhode Island residents.
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1-17
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23-25.4-3. Definitions. -- For the purposes of this chapter:
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1-18
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(1) "Assisted living residence" has the same meaning as such term is defined in section
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1-19
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23-17.4-2 and the regulations promulgated thereunder.
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2-20
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(2) "Blister packages" means multi-dose containers of a specific medication repackaged
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2-21
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by the pharmacy in accordance with section 13.7 of the regulations promulgated under chapter
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2-22
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19.1 of title 5 and intended for a specific patient.
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2-23
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(3) "Cancer drugs" means any of several drugs that control or kill neoplastic cells,
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2-24
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commonly referred to as "cancer-fighting chemotherapy" to destroy cancer cells.
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2-25
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(4) "Charitable clinic" means an organized ambulatory care facility licensed pursuant to
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2-26
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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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(i) Holds a valid exemption from federal income taxation issued pursuant to Section
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2-28
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501(a) of the Internal Revenue Code, 26 U.S.C. section 501(1);
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(ii) Has a licensed outpatient pharmacy located at the organized ambulatory care facility
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2-30
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or a contract with a retail pharmacy to participate in the program established under this chapter.
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2-31
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(5) "Health care prescriber" means any of the following persons licensed and authorized
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2-32
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to prescribe drugs or to provide medical, dental, or other health-related diagnoses, care or
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2-33
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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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2-35
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title 5;
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2-36
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(ii) A certified registered nurse practitioner licensed pursuant to chapter 34 of title 5;
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2-37
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(iii) A physician assistant licensed pursuant to chapter 54 of title 5;
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2-38
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(iv) A dentist licensed pursuant to chapter 31.1 of title 5;
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2-39
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(v) An optometrist licensed pursuant to chapter 35 of title 5; and
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2-40
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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 chapter 13 of title 23; and
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(viii) A psychiatric and mental health clinical nurse specialist licensed pursuant to
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chapter 34 of title 5.
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2-44
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(6) "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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2-46
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prescribed drugs.
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2-47
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(7) "Prescription drug" means a drug that may be dispensed only upon prescription by a
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2-48
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health care prescriber authorized by his or her licensing authority and as defined in chapter 5-
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2-49
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19.1.
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(8) "Unit-dose container" is one that is designed to hold a quantity of a drug intended for
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2-51
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use as a single dose and used promptly after the container is opened. The immediate container,
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2-52
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and/or the outer container or protective packaging shall be designed to show evidence of any
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2-53
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tampering with the contents. Each individual container shall be fully identifiable containing a
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2-54
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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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3-1
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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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3-3
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expiration date of the article.
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3-4
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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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3-6
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safety through which unused prescription drugs, other than prescription drugs defined as
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3-7
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controlled substances in section 21-28-1.02, shall be transferred from nursing facilities, assisted
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3-8
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living residences, residential care facilities or community health organizations that centrally store
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3-9
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prescription drugs and are licensed at the M1 licensure level by the department of health to
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3-10
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charitable clinics for the purpose of re-dispensing the medication to Rhode Island residents who
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3-11
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are medically indigent.
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3-12
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(b) The pilot program shall conform to the requirements established in rules promulgated
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3-13
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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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3-14
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effect until January 1, 2012.
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3-15
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(c) The state department of health and the board of pharmacy shall review and evaluate
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3-16
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the pilot program and shall submit a report and any recommendations to the governor, the speaker
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3-17
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of the house of representatives, and the president of the senate on or before January 1, 2012.
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3-18
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(d) Beginning April 1, 2010, the department of health and the board of pharmacy shall
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3-19
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implement statewide a program consistent with public health and safety through which unused
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3-20
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prescription drugs, other than prescription drugs defined as controlled substances in section 21-
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3-21
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28-1.02, shall be transferred from nursing facilities or assisted living residences to charitable
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3-22
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clinics for the purpose of re-dispensing the unused prescription drugs.
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3-23
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(e) The department of health and the board of pharmacy shall promulgate rules and
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3-24
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establish procedures necessary to implement the program established pursuant to this chapter.
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3-25
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(f) The board of pharmacy shall provide technical assistance to entities who may wish to
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3-26
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participate in the program.
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3-27
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(g) The department of health shall be required to provide written notification to all
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3-28
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eligible nursing homes, assisted living facilities, residential care facilities and community health
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3-29
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organizations and to post a sign clearly and conspicuously in each facility to notify its residents of
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3-30
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the program.
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3-31
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23-25.4-5. Criteria. -- The following criteria shall be used in soliciting and accepting
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3-32
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unused prescription drugs for use pursuant to this chapter:
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3-33
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(1) Nursing facilities and assisted living residences that have entered into an agreement
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3-34
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to participate with a charitable clinic shall document residents' participation in the program with a
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4-1
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written statement that their excess and otherwise eligible unused prescription drugs shall be
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4-2
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donated to a charitable clinic for the purpose of re-dispensing to medically indigent persons.
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Participation in this program by residents of participating nursing facilities and assisted living
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4-4
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residences shall be strictly voluntary.
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(2) Only prescription drugs in their original sealed multi-dose blister packages, unit dose
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4-6
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containers or perforated blister packages shall be accepted and re-dispensed;
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4-7
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(3) Expired or beyond use date prescription drugs shall not be accepted;
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4-8
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(4) A prescription drug shall not be accepted or re-dispensed if the pharmacist accepting
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4-9
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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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4-10
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mislabeled, or has been improperly stored;
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4-11
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(5) No controlled substances shall be accepted; and
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4-12
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(6) Subject to the limitation specified in this section, unused prescription drugs dispensed
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4-13
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for purposes of a medical assistance program may be accepted and re-dispensed pursuant to this
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4-14
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chapter.
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4-15
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23-25.4-6. Participation. -- (a) Participation in the program established in this chapter by
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4-16
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individual residents of any assisted living residence or nursing facility, pharmacies, nursing
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4-17
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facilities, assisted living residences, charitable clinics or prescription drug manufacturers shall be
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4-18
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voluntary. Nothing in this chapter shall require any resident of any assisted living residence or
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4-19
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nursing facility, pharmacy, pharmacists, charitable clinic or prescription drug manufacturer to
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4-20
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participate in the program.
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4-21
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(b) A pharmacy operating in conjunction with a charitable clinic may:
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4-22
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(1) Re-dispense prescription drugs donated pursuant to this chapter to persons who are
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4-23
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medically indigent residents of Rhode Island.
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4-24
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(c) A pharmacy operating in conjunction with a charitable clinic wherein both meet the
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4-25
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eligibility requirements established and authorized by this chapter and that accepts donated
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4-26
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prescription drugs shall:
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4-27
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(1) Comply with all applicable federal and state laws relating to the storage, distribution,
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4-28
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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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4-30
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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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4-32
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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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5-34
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23-25.4-7. Liability. -- (a) For matters related only to the lawful donation, acceptance, or
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5-35
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re-dispensing of prescription drugs under this chapter, the following persons and entities, in
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5-36
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compliance with the criteria set forth in this chapter, in the absence of bad faith shall not be
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5-37
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subject to criminal or civil liability for injury, death, or loss to person or property, or professional
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5-38
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disciplinary action:
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5-39
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(1) The board of pharmacy;
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5-40
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(2) Any resident of a nursing facility or assisted living residence who agrees to donate
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5-41
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unused prescription drugs, or his/her next of kin or legal guardian or estate;
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5-42
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(3) The department of mental health, retardation and hospitals;
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5-43
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(4) Any charitable clinic, prescription drug manufacturer, governmental entity, nursing
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5-44
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facility, or assisted living residence who participates in the program for the reuse of prescription
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5-45
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drugs pursuant to this chapter;
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5-46
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(5) Any prescription drug manufacturer or its representative that directly donates
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5-47
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prescription drugs in professional samples to a charitable clinic or a pharmacy pursuant to this
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5-48
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chapter;
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5-49
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(6) Any charitable clinic, health care prescriber or pharmacy that accepts or re-dispenses
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5-50
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prescription drugs pursuant to this chapter; and
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5-51
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(7) Any pharmacy or pharmacist operating in conjunction with a charitable clinic, or
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5-52
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other state-contracted pharmacy that employs a health care professional who accepts or can
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5-53
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legally dispense prescription drugs pursuant to this chapter.
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5-54
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(b) For matters related to the donation, acceptance, or dispensing of a prescription drug
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5-55
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manufactured by the prescription drug manufacturer that is donated by any entity pursuant to this
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5-56
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chapter, a prescription drug manufacturer shall not, in the absence of bad faith be subject to
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5-57
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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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5-58
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to, liability for failure to transfer or communicate product or consumer information or the
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5-59
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expiration date of the donated prescription drug.
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5-60
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23-25.4-8. Rules. -- (a) The board of pharmacy shall promulgate rules by December 1,
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5-61
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2005, to implement the provisions of this chapter. Such rules may include:
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5-62
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(1) Eligibility criteria for pharmacies and charitable clinics authorized to receive and
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5-63
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dispense donated prescription drugs pursuant to this chapter;
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5-64
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(2) Establishment of a formulary which shall include all prescription drugs approved by
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5-65
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the federal Food and Drug Administration;
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5-66
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(3) Standards and procedures for transfer, acceptance, safe storage, security, and
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5-67
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dispensing of donated prescription drugs;
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6-68
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(4) A process for seeking input from the state department of health in establishing
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6-69
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provisions which affect nursing homes and assisted living residences;
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6-70
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(5) A process for seeking input form the department of mental health, retardation and
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6-71
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hospitals in establishing provisions which affect mental heath and substance abuse clients;
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6-72
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(6) Standards and procedures for inspecting donated prescription drugs to ensure that the
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6-73
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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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6-74
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judgment of the pharmacist, the medications meet all federal and state standards for product
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6-75
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integrity;
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6-76
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(7) Procedures for destruction of medications that are donated which are controlled
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6-77
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substances;
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6-78
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(8) Procedures for verifying whether the pharmacy and responsible pharmacist
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6-79
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participating in the program are licensed and in good standing with the board of pharmacy;
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6-80
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(9) Establishment of standards for acceptance of unused prescription medications from
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6-81
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assisted living residences; and
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6-82
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(10) Any other standards and procedures the board of pharmacy deems appropriate or
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6-83
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necessary to implement the provisions of this chapter.
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6-84
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(b) In accordance with the rules and procedures of the program established pursuant to
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6-85
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this section, a resident of a nursing facility or assisted living residence, or the representative or
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6-86
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guardian of a resident may donate unused prescription medications, other than prescription drugs
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6-87
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defined as controlled dangerous substances, to charitable clinics for dispensing to medically
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6-88
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indigent persons.
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6-89
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23-25.4-9. Establishment of oversight commission on utilization of unused
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6-90
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prescription drugs -- Membership. -- (a) There is hereby established a commission on the
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6-91
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utilization of prescription drugs to oversee the development and implementation of the pilot
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6-92
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program for the utilization of unused prescription drugs as established pursuant to this chapter.
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6-93
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(b) The commission shall consist of five (5) members to be appointed by the speaker of
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6-94
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the house, not more than three (3) from the same political party. Any vacancy on the commission,
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6-95
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occurring for any reason prior to the expiration of the term, shall be filled for the unexpired term
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6-96
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by the appointing authority in the same manner as the original appointment.
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6-97
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SECTION 2. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby
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6-98
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amended by adding thereto the following chapter:
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6-99
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CHAPTER 25.5
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6-100
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THE RETURN OR EXCHANGE OF DRUGS ACT
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6-101
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23-25.5-1. Short title. -- This act shall be known and may be cited as "The Return or
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6-102
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Exchange of Drugs Act."
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7-1
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23-25.5-2. Legislative purpose. -- The general assembly finds that many nursing
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7-2
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facilities and assisted living residences destroy quantities of unused but viable prescription
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7-3
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medication when residents pass away or when medications otherwise are no longer needed by the
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7-4
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resident. In an effort to improve the quality, efficiency and utilization of the state's healthcare
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7-5
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system, the general assembly hereby establishes a statewide program allowing pharmacies to
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7-6
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accept for return and redispensing certain prescription drugs.
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7-7
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23-25.5-3. Definitions. – For the purposes of this chapter:
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7-8
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(1) "Assisted living residence" has the same meaning as such term is defined in section
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7-9
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23-17.4-2 and the regulations promulgated thereunder.
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7-10
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(2) "Blister packages" means multi-dose containers of a specific medication repackaged
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7-11
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by the pharmacy in accordance with section 13.7 of the regulations promulgated under chapter
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7-12
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19.1 of title 5 and intended for a specific patient.
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7-13
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(3) "Department" means the department of health.
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7-14
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(4) "Healthcare prescriber" means any of the following persons licensed and authorized
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7-15
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to prescribe drugs or to provide medical, dental, or other health-related diagnoses, care or
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7-16
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treatment within the scope of their professional license:
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7-17
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(i) A physician holding a current license to practice medicine pursuant to chapter 37 of
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7-18
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title 5;
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7-19
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(ii) A certified registered nurse practitioner licensed pursuant to chapter 34 of title 5;
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7-20
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(iii) A physician assistant licensed pursuant to chapter 54 of title 5;
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7-21
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(iv) A dentist licensed pursuant to chapter 31.1 of title 5;
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7-22
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(v) An optometrist licensed pursuant to chapter 35 of title 5;
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7-23
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(vi) A pharmacist licensed pursuant to chapter 19.1 of title 5;
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7-24
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(vii) A nurse – midwife licensed pursuant to chapter 13 of title 23; and
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7-25
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(viii) A psychiatric and mental health clinical nurse specialist licensed pursuant to chapter
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7-26
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34 of title 5.
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7-27
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(5) "Pharmacy" means that portion or part of a premises where prescriptions are
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7-28
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compounded and dispensed including that portion utilized for the storage of prescription or
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7-29
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legend drugs.
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7-30
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(6) "Prescription drug" means a drug that may be dispensed only upon prescription by a
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7-31
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healthcare prescriber authorized by his or her licensing authority and as defined in chapter 5-19.1.
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7-32
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(7) "Unit-dose container" is one that is designed to hold a quantity of a drug intended for
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7-33
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use as a single dose and used promptly after the container is opened. The immediate container,
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7-34
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and/or the outer container or protective packaging shall be designed to show evidence of any
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8-1
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tampering with the contents. Each individual container shall be fully identifiable containing a
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8-2
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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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8-3
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in accordance with USP standards compendia and federal and state law and shall include the
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8-4
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identity, quantity, and strength of the product, name of the manufacturer, and lot number and
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8-5
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expiration date of the article.
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8-6
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(8) "Wholesaler" means a person who buys drugs or devices for resale and distribution to
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8-7
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corporations, individuals, or entities other than consumers.
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8-8
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23-25.5-4. Program established. -- (a) The department of health and the board of
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8-9
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pharmacy shall jointly develop and implement a program consistent with public health and safety
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8-10
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through which unused prescription drugs, other than prescription drugs defined as controlled
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8-11
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substances in section 21-28-1.02, may be accepted by wholesalers or pharmacies, from which
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8-12
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they were purchased, for return from nursing facilities, assisted living residences, residential care
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8-13
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facilities, community health organizations and state correctional facilities that centrally store
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8-14
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prescription drugs and are licensed at the M1 licensure level by the department of health.
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8-15
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(b) The program shall permit the wholesaler or pharmacy to which such medication is
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8-16
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returned to repackage, restock, and redistribute such medication.
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8-17
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(c) The program shall include the following prescription drugs:
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8-18
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(1) Unopened sections of blister pack prescription medication, with seal intact.
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8-19
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(2) Unopened unit-dose containers of liquids with the safety seal intact.
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8-20
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(3) Unopened unit-dose containers of powders for oral solution with safety seal intact.
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8-21
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(4) Unused injectables, with safety seal intact.
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8-22
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(d) The unused prescription drug shall not be accepted, repackaged or redispensed if:
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8-23
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(1) The prescription drug is expired or beyond use date;
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8-24
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(2) The pharmacist accepting or redispensing the drug, in his or her judgment has reason
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8-25
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to believe that the prescription drug is adulterated, mislabeled, or has been improperly stored; and
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8-26
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(3) The prescription drug is defined as controlled substances in section 21-28-1.02.
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8-27
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(e) The wholesaler or pharmacy shall be required to reimburse or credit the purchaser for
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8-28
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any such returned prescription drugs.
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8-29
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(f) The department and the board of pharmacy shall promulgate rules and regulations
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8-30
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necessary to implement the program established pursuant to this chapter within one hundred
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8-31
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eighty days (180) of passage of this act.
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9-32
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SECTION 3. This act shall take effect upon passage.
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LC00655
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EXPLANATION
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BY THE LEGISLATIVE COUNCIL
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OF
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A N A C T
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RELATING TO HEALTH AND SAFETY - THE RETURN OR EXCHANGE OF DRUGS ACT
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***
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10-1
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This act would repeal "The Utilization of Unused Prescription Drugs Act" and would
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10-2
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establish a new program known as "The Return or Exchange of Drugs Act" which would allow
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10-3
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pharmacies to accept for return and redispensing certain prescription drugs.
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10-4
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This act would take effect upon passage.
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LC00655
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