2023 -- S 0570
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LC002534
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S TATE OF RHODE IS LAND
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2023
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A N A C T
RELATING TO HEALTH AND SAFETY -- PREVENTION AND SUPPR ESSION OF
CONTAGIOUS DISEASES -- HIV/AIDS
Introduced By: Senators Miller, Valverde, Sosnowski, DiMario, Lawson, Mack, Euer,
Lauria, and Murray
Date Introduced: March 07, 2023
Referred To: Senate Health & Human Services
It is enacted by the General Assembly as follows:
SECTION 1. Chapter 23-6.3 of the General Laws entitled "Prevention and Suppression of 1
Contagious Diseases — HIV/AIDS" is hereby amended by adding thereto the following section: 2
23-6.3-20. HIV prevention drug. 3
(a) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs in 4
accordance with rules and regulations promulgated by the department of health in accordance with 5
this section. 6
(b) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs 7
according to the United States Food and Drug Administration guidance and product labeling if the 8
patient: 9
(1) Is HIV negative, as documented by a negative HIV test result obtained within the 10
previous seven (7) days from an HIV antigen and antibody test or antibody-only test or from a 11
rapid, point-of-care fingerstick blood test approved by the United States Food and Drug 12
Administration; provided, however, that if the patient does not provide evidence of a negative HIV 13
test in accordance with this subsection, the pharmacist may order an HIV test prior to prescribing, 14
dispensing or administering the drugs; provided further, that if the test results are not transmitted 15
directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction 16
prior to prescribing, dispensing or administering the drugs; and provided further, that if the patient 17
tests positive for HIV infection, the pharmacist or person administering the test shall direct the 18
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patient to a primary care provider and provide the patient with a list of providers and clinics in the 1
region; 2
(2) Does not report any signs or symptoms of acute HIV infection on a self-reported 3
checklist of acute HIV infection signs and symptoms; and 4
(3) Does not report taking any contraindicated medication. 5
(c) A licensed pharmacist that prescribes, dispenses or administers HIV prevention drugs 6
shall: 7
(1) Provide counseling to the patient on the ongoing use of pre-exposure prophylaxis, 8
which may include education about side effects, safety during pregnancy and breastfeeding, 9
adherence to recommended dosing and the importance of timely testing and treatment, as 10
applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted infections and 11
pregnancy for individuals of child-bearing capacity; 12
(2) Notify the patient that the patient is required to be seen by a primary care provider to 13
receive subsequent prescriptions for pre-exposure prophylaxis and that a pharmacist shall not 14
furnish a sixty (60) day supply of pre-exposure prophylaxis to a single patient more than once every 15
two (2) years; 16
(3) Document, to the extent possible, the services provided to the patient by the pharmacist 17
in the patient’s record in the record system maintained by the pharmacy and maintain records of 18
pre-exposure prophylaxis furnished to each patient; and 19
(4) Notify the patient’s primary care provider that the pharmacist completed the 20
requirements specified in this subsection; provided, however, that if the patient does not have a 21
primary care provider or refuses to consent to notify the patient’s primary care provider, the 22
pharmacist shall provide the patient a list of physicians and surgeons, clinics or other health care 23
service providers to contact regarding ongoing care for pre-exposure prophylaxis. 24
(d) The department of health shall promulgate rules and regulations to establish statewide 25
drug therapy protocols for prescribing, dispensing and administering pre-exposure prophylaxis and 26
other HIV prevention drugs approved by the United States Food and Drug Administration that are 27
consistent with federal Centers for Disease Control and Prevention guidelines not later than six (6) 28
months after the effective date of this section. The regulations shall include, but not be limited to, 29
rules stating that a pharmacist shall not furnish a sixty (60) day supply of pre-exposure prophylaxis 30
to a single patient more than once every two (2) years. 31
SECTION 2. Section 23-6.3-2 of the General Laws in Chapter 23-6.3 entitled "Prevention 32
and Suppression of Contagious Diseases — HIV/AIDS" is hereby amended to read as follows: 33
23-6.3-2. Definitions. 34
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As used in this chapter the following words shall have the following meanings: 1
(1) “Agent” means a person empowered by the patient to assert or waive the confidentiality, 2
or to disclose or consent to the disclosure of confidential information, as established by chapter 3
37.3 of title 5, as amended, entitled “Confidentiality of Health Care Communications and 4
Information Act.” 5
(2) “AIDS” means the medical condition known as acquired immune deficiency syndrome, 6
caused by infection of an individual by the human immunodeficiency virus (HIV). 7
(3) “Anonymous HIV testing” means an HIV test that utilizes a laboratory generated code 8
based system, which does not require an individual’s name or other identifying information that 9
may reveal one’s identity, including information related to the individual’s health insurance policy, 10
to be associated with the test. 11
(4) “Antibody” means a protein produced by the body in response to specific foreign 12
substances such as bacteria or viruses. 13
(5) “Community-based organization” means an entity that has written authorization from 14
the department for HIV counseling, testing and referral services (HIV CTRS). 15
(6) “Confidential HIV testing” means an HIV test that requires the individual’s name and 16
other identifying information including information related to the individual’s health insurance 17
policy, as appropriate. 18
(7) “Consent” means an explicit exchange of information between a person and a 19
healthcare provider or qualified professional HIV test counselor through which an informed 20
individual can choose whether to undergo HIV testing or decline to do so. Elements of consent 21
shall include providing each individual with verbal or written information regarding an explanation 22
of HIV infection, a description of interventions that can reduce HIV transmission, the meanings of 23
positive and negative test results, the voluntary nature of the HIV testing, an opportunity to ask 24
questions and to decline testing. 25
(8) “Controlled substance” means a drug, substance, or immediate precursor in schedules 26
I-V listed in the provisions of chapter 28 of title 21 entitled, “Uniform Controlled Substances Act.” 27
(9) “Department” means the Rhode Island department of health. 28
(10) “Diagnosis of AIDS” means the most current surveillance case definition for AIDS 29
published in the Centers for Disease Control & Prevention (CDC). 30
(11) “Diagnosis of HIV” means the most current surveillance case definition for HIV 31
infection published in the CDC’s (MMWR). 32
(12) “Director” means the director of the Rhode Island department of health. 33
(13) “ELISA result” means enzyme-linked immunosorbent assay or EIA (enzyme 34
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immunoassay) which is a serologic technique used in immunology to detect the presence of either 1
antibody or antigen. 2
(14) “Health benefits” include accident and sickness, including disability or health 3
insurance, health benefit plans and/or policies, hospital, health, or medical service plans, or any 4
health maintenance organization plan pursuant to title 27 or otherwise. 5
(15) “Healthcare facility” means those facilities licensed by the department in accordance 6
with the provisions of chapter 17 of this title. 7
(16) “Healthcare provider,” as used herein, means a licensed physician, physician assistant, 8
certified nurse practitioner or midwife. 9
(17) “Healthcare settings” means venues offering clinical STD services including, but not 10
limited to, hospitals, urgent care clinics, STD clinics and other substance abuse treatment facilities, 11
mental health treatment facilities, community health centers, primary care and OB/GYN physician 12
offices, and family planning providers. 13
(18) “HIV” means the human immunodeficiency virus, the pathogenic organism 14
responsible for HIV infection and/or the acquired immunodeficiency syndrome (AIDS) in humans. 15
(19) “HIV CD4 T-lymphocyte test result” means the results of any currently medically 16
accepted and/or FDA approved test used to count CD4 T-lymphatic cells in the blood of an HIV-17
infected person. 18
(20) “HIV counseling” means an interactive process of communication between a person 19
and a healthcare provider or qualified professional HIV test counselor during which there is an 20
assessment of the person’s risks for HIV infection and the provision of counseling to assist the 21
person with behavior changes that can reduce risks for acquiring HIV infection. 22
(21) “HIV prevention drug” means a drug approved by the United States Food and Drug 23
Administration for the prevention of HIV, including, but not limited to, pre-exposure prophylaxis. 24
(22) “HIV screening” means the conduct of HIV testing among those who do not show 25
signs or symptoms of an HIV infection. 26
(22)(23) “HIV test” means any currently medically accepted and/or FDA approved test for 27
determining HIV infection in humans. 28
(23)(24) “Occupational health representative” means a person, within a healthcare facility, 29
trained to respond to occupational, particularly blood borne, exposures. 30
(24)(25) “Opts out” means that a person who has been notified that a voluntary HIV test 31
will be performed, has elected to decline or defer testing. Consent to HIV testing is inferred unless 32
the individual declines testing. 33
(25)(26) “Perinatal case report for HIV” means the information that is provided to the 34
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department related to a child aged less than eighteen (18) months born to an HIV-infected mother 1
and the child does not meet the criteria for HIV infection or the criteria for “not infected” with HIV 2
as defined in the most current surveillance case definition for HIV infection published by the CDC. 3
(26)(27) “Person” means any individual, trust or estate, partnership, corporation (including 4
associations, joint stock companies), limited liability companies, state, or political subdivision or 5
instrumentality of a state. 6
(27)(28) “Persons at high risk for HIV infection” means persons defined as being high risk 7
in the CDC’s most current recommendations for HIV testing of adults, adolescents and pregnant 8
women in healthcare settings or through authority and responsibilities conferred on the director by 9
law in protecting the public’s health. 10
(28)(29) “Polymerase chain reaction (PCR) test” means a common laboratory method of 11
creating copies of specific fragments of DNA or RNA. 12
(29)(30) “Pre-exposure prophylaxis” means a drug or drug combination that is taken or 13
administered to reduce the risk of HIV acquisition and meets the same clinical eligibility 14
recommendations provided in current guidelines of the federal Centers for Disease Control and 15
Prevention. 16
(31) “Qualified professional HIV test counselor” means: (i) A physician, physician 17
assistant, certified nurse practitioner, midwife, or nurse licensed to practice in accordance with 18
applicable state law; (ii) A medical student who is actively matriculating in a medical degree 19
program and who performs duties assigned to them by a physician; or (iii) A person who has 20
completed an HIV counseling training program, in accordance with regulations hereunder 21
promulgated. 22
(30)(32) “Sexually transmitted diseases (STD’s)” means those diseases included in § 23-23
11-1, as amended, entitled “Sexually Transmitted Diseases,” and any other sexually transmitted 24
disease that may be required to be reported by the department. 25
SECTION 3. This act shall take effect upon passage. 26
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EXPLANATION
BY THE LEGISLATIVE COUNCIL
OF
A N A C T
RELATING TO HEALTH AND SAFETY -- PREVENTION AND SUPPR ESSION OF
CONTAGIOUS DISEASES -- HIV/AIDS
***
This act would permit a licensed pharmacist to prescribe, dispense or administer HIV 1
prevention drugs once every two (2) years to an individual who is HIV negative, does not report 2
any signs or symptoms of acute HIV infection, and does not report taking any contraindicated 3
medication. A licensed pharmacist prescribing, dispensing or administering HIV prevention drugs 4
shall counsel the individual receiving the drug on the ongoing use of the drug and notify the patient 5
that they must be seen by a primary care provider to receive subsequent dosages. 6
This act would take effect upon passage. 7
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LC002534
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