Chapter
179
2005 -- H 5107 SUBSTITUTE B AS AMENDED
Enacted 07/06/05
A N A C T
RELATING TO HEALTH AND SAFETY
Introduced By: Representatives Sullivan, Corvese, Moura, McNamara, and Costantino
Date Introduced: January 18, 2005
It is enacted by the General Assembly as follows:
SECTION
1. Title 23 of the General Laws entitled "Health and Safety" is
hereby
amended
by adding thereto the following chapter:
CHAPTER
25.4
UTILIZATION OF UNUSED
PRESCRIPTION DRUGS ACT
23-25.4-1.
Title. -- This act may be cited as the "Utilization of Unused
Prescription
Drugs
Act."
23-25.4-2.
Legislative purpose. -- The general assembly has determined that the
high
cost
of prescription drugs is a burden on the uninsured who may forego the drugs
they need or
take
only partial doses which can ultimately increase health costs. The general
assembly has also
determined
that many nursing facilities and assisted living residences destroy quantities
of unused
but
viable prescription medications when residents pass away or when medications
otherwise are
no
longer needed by the resident. In an effort to improve the quality, efficiency
and utilization of
the
state's health care system, the general assembly hereby establishes a voluntary
statewide pilot
program
allowing nursing facilities and assisted living residences to transfer from
their facilities
unused
prescription drugs to authorized participating pharmacies for distribution to
medically
indigent
Rhode Island residents.
23-25.4-3.
Definitions. – For the purposes of this chapter:
(a)
"Assisted living residence" has the same meaning as such term is
defined in section
23-17.4-2
and the regulations promulgated thereunder.
(b)
"Blister packages' means multi-dose containers of a specific medication
repackaged
by
the pharmacy in accordance with section 13.7 of the regulations promulgated
under chapter
19.1
of title 5 and intended for a specific patient.
(c)
"Cancer drugs" means any of several drugs that control or kill
neoplastic cells,
commonly
referred to as "cancer-fighting chemotherapy" to destroy cancer
cells.
(d)
"Health care prescriber" means any of the following persons licensed
and authorized
to
prescribe drugs or to provide medical, dental, or other health-related
diagnoses, care or
treatment
within the scope of their professional license:
(i)
A physician holding a current license to practice medicine pursuant to chapter
37 of
title
5;
(ii)
A certified registered nurse practitioner licensed pursuant to chapter 34 of
title 5;
(iii)
A physician assistant licensed pursuant to chapter 54 of title 5;
(iv)
A dentist licensed pursuant to chapter 31.1 of title 5;
(v)
An optometrist licensed pursuant to chapter 35 of title 5; and
(vi)
A pharmacist licensed pursuant to chapter 19.1 of title 5.
(vii)
A nurse – midwife licensed pursuant to chapter 13 of title 23; and
(viii)
A psychiatric and mental health clinical nurse specialist licensed pursuant to
chapter
34 of
title 5.
(e)
"Medically indigent" means a person eligible to receive Medicaid or
Medicare or a
person
who has no health insurance and who otherwise lacks reasonable means to
purchase
prescribed
drugs.
(f)
"Charitable clinic" means an organized ambulatory care facility
licensed pursuant to
chapter
17 of title 23 organized as a nonprofit corporation pursuant to section 7-6-2
that:
(1)
Holds a valid exemption from federal income taxation issued pursuant to Section
501(a)
of the Internal Revenue Code (26 U.S.C., Section 501(1);
(2)
Has a licensed outpatient pharmacy located at the organized ambulatory care
facility
or a
contract with a retail pharmacy to participate in the program established under
this chapter.
(g)
"Prescription drug" means a drug that may be dispensed only upon
prescription by a
health
care prescriber authorized by his or her licensing authority and as defined in chapter 5-
19.1.
(h)
"Unit-dose container" is one that is designed to hold a quantity of a
drug intended for
use
as a single dose and used promptly after the container is opened. The immediate
container,
and/or
the outer container or protective packaging shall be designed to show evidence
of any
tampering
with the contents. Each individual container shall be fully identifiable
containing a
single
dose of a single entity and shall protect the integrity of the dosage form.
Labeling shall be
in
accordance with USP standards compendia and federal and state law and shall
include the
identity,
quantity, and strength of the product, name of the manufacturer, and lot number
and
expiration
date of the article.
23-25.4-4.
Program established. -- (a) The department of health and the board
of
pharmacy
shall jointly develop and implement a pilot program consistent with public
health and
safety
through which unused prescription drugs, other than prescription drugs defined
as
controlled
substances in section 21-28-1.02, may be transferred from nursing facilities or
assisted
living
residences that centrally store prescription drugs and are licensed at the M1
licensure level
by
the department of health to charitable clinics for the purpose of re-dispensing
the medication
to
Rhode Island residents who are medically indigent.
(b) The pilot program shall conform to the requirements established in rules
promulgated
by
the state department of health and the board of pharmacy. The pilot program
shall remain in
effect
until January 1, 2007.
(c) The state department of health and the board of pharmacy shall review
and evaluate
the
pilot program and shall submit a report and any recommendations to the
governor, the speaker
of
the house of representatives, and the president of the senate on or before
January 1, 2007.
(d) Beginning January 1, 2006, the department of health and the board of
pharmacy shall
implement
statewide a program consistent with public health and safety through which
unused
prescription
drugs, other than prescription drugs defined as controlled substances in
section 21-
28-1.02,
may be transferred from nursing facilities or assisted living residences to
charitable
clinics
for the purpose of re-dispensing the unused prescription drugs.
(e) The department of health and the board of pharmacy shall promulgate
rules and
establish
procedures necessary to implement the program established pursuant to this
chapter.
(f) The board of pharmacy shall provide technical assistance to entities who
may wish to
participate
in the program.
23-25.4-5.
Criteria. -- The following criteria shall be used in soliciting and
accepting
unused
prescription drugs for use pursuant to this chapter:
(a)
Nursing facilities and assisted living residences that have entered into an
agreement to
participate
with a charitable clinic shall document residents’ participation in the program
with a
written
statement that their excess and otherwise eligible unused prescription drugs
shall be
donated
to a charitable clinic for the purpose of re-dispensing to medically indigent
persons.
Participation
in this program by residents of participating nursing facilities and assisted
living
residences
shall be strictly voluntary.
(b)
Only prescription drugs in their original sealed multi-dose blister packages,
unit dose
containers
or perforated blister packages shall be accepted and re-dispensed;
(c)
Expired or beyond use date prescription drugs shall not be accepted;
(d)
A prescription drug shall not be accepted or re-dispensed if the pharmacist
accepting
or
re-dispensing the drug, in his or her judgment has reason to believe that the
drug is adulterated,
mislabeled,
or has been improperly stored;
(e)
No controlled substances shall be accepted; and
(f)
Subject to the limitation specified in this section, unused prescription drugs
dispensed
for
purposes of a medical assistance program may be accepted and re-dispensed
pursuant to this
chapter.
23-25.4-6.
Participation. -- (a) Participation in the program established in
this chapter by
individual
residents of any assisted living residence or nursing facility, pharmacies,
nursing
facilities,
assisted living residences, charitable clinics or prescription drug
manufacturers shall be
voluntary.
Nothing in this chapter shall require any resident of any assisted living
residence or
nursing
facility, pharmacy, pharmacists, charitable clinic or prescription drug
manufacturer to
participate
in the program.
(b)
A pharmacy operating in conjunction with a charitable clinic may:
(1)
Re-dispense prescription drugs donated pursuant to this chapter to persons who
are
medically
indigent residents of Rhode Island.
(c)
A pharmacy operating in conjunction with a charitable clinic wherein both meet
the
eligibility
requirements established and authorized by this chapter and that accepts
donated
prescription
drugs shall:
(1)
Comply with all applicable federal and state laws relating to the storage,
distribution,
and
dispensing of prescription drugs;
(2)
Inspect all prescription drugs prior to re-dispensing the prescription drugs to
determine
that such drugs are not adulterated; and
(3)
Re-dispense prescription drugs only pursuant to a valid prescription issued by
a
health
care prescriber.
(d)
Prescription drugs donated pursuant to this chapter shall not be resold.
23-25.4-7.
Liability. -- (a) For matters related only to the lawful donation,
acceptance, or
re-dispensing
of prescription drugs under this chapter, the following persons and entities,
in
compliance
with the criteria set forth in this chapter, in the absence of bad faith shall
not be
subject
to criminal or civil liability for injury, death, or loss to person or
property, or professional
disciplinary
action:
(1)
The board of pharmacy;
(2)
Any resident of a nursing facility or assisted living residence who agrees to
donate
unused
prescription drugs, or his/her next of kin or legal guardian or estate;
(3)
The department of mental health, retardation and hospitals;
(4)
Any charitable clinic, prescription drug manufacturer, governmental entity,
nursing
facility,
or assisted living residence who participates in the program for the reuse of
prescription
drugs
pursuant to this chapter;
(5)
Any prescription drug manufacturer or its representative that directly donates
prescription
drugs in professional samples to a charitable clinic or a pharmacy pursuant to
this
chapter;
(6)
Any charitable clinic, health care prescriber or pharmacy that accepts or
re-dispenses
prescription
drugs pursuant to this chapter; and
(7)
Any pharmacy or pharmacist operating in conjunction with a charitable clinic,
or
other
state-contracted pharmacy that employs a health care professional who accepts
or can
legally
dispense prescription drugs pursuant to this chapter.
(b)
For matters related to the donation, acceptance, or dispensing of a
prescription drug
manufactured
by the prescription drug manufacturer that is donated by any entity pursuant to
this
chapter,
a prescription drug manufacturer shall not, in the absence of bad faith be
subject to
criminal
or civil liability for injury, death, or loss to person or property including,
but not limited
to,
liability for failure to transfer or communicate product or consumer
information or the
expiration
date of the donated prescription drug.
23-25.4-8.
Rules. -- (a) The board of pharmacy shall promulgate rules by
December 1,
2005,
to implement the provisions of this chapter. Such rules may include:
(1)
Eligibility criteria for pharmacies and charitable clinics authorized to
receive and
dispense
donated prescription drugs pursuant to this chapter;
(2)
Establishment of a formulary which shall include all prescription drugs
approved by
the
federal Food and Drug Administration;
(3)
Standards and procedures for transfer, acceptance, safe storage, security, and
dispensing
of donated prescription drugs;
(4)
A process for seeking input from the state department of health in establishing
provisions
which affect nursing homes and assisted living residences;
(5)
A process for seeking input form the department of mental health, retardation
and
hospitals
in establishing provisions which affect mental heath and substance abuse
clients;
(6)
Standards and procedures for inspecting donated prescription drugs to ensure
that the
drugs
are in compliance with the provisions of this chapter and to ensure that, in
the professional
judgment
of the pharmacist, the medications meet all federal and state standards for
product
integrity;
(7)
Procedures for destruction of medications that are donated which are controlled
substances;
(8)
Procedures for verifying whether the pharmacy and responsible pharmacist
participating
in the program are licensed and in good standing with the board of pharmacy;
(9)
Establishment of standards for acceptance of unused prescription medications
from
assisted
living residences; and
(10)
Any other standards and procedures the board of pharmacy deems appropriate or
necessary
to implement the provisions of this chapter.
(b)
In accordance with the rules and procedures of the program established pursuant
to
this
section, a resident of a nursing facility or assisted living residence, or the
representative or
guardian
of a resident may donate unused prescription medications, other than
prescription drugs
defined
as controlled dangerous substances, to charitable clinics for dispensing to
medically
indigent
persons.
SECTION 2. This act shall
take effect upon passage.
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LC00295/SUB B
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