2021 -- H 5247 SUBSTITUTE A

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2021

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A N   A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT

     Introduced By: Representatives Amore, and Kazarian

     Date Introduced: January 29, 2021

     Referred To: House Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Sections 5-37.4-2 and 5-37.4-3 of the General Laws in Chapter 5-37.4 entitled

"Intractable Pain Treatment" are hereby amended to read as follows:

     5-37.4-2. Definitions.

     For purposes of this chapter:

     (1) "Chronic intractable pain" means pain that is: excruciating; constant; incurable, and of

such severity that it dominates virtually every conscious moment; and/or produces mental and

physical debilitation. A diagnosis and written documentation of chronic intractable pain made by a

physician licensed in the state of Rhode Island specializing in pain management, oncology or

similar specialty defined in regulations shall constitute proof that the patient suffers from chronic

intractable pain.

     (1)(2) "Director" means the director of the department of health of the state of Rhode

Island.

     (2)(3) "Intractable pain" means a pain state that persists beyond the usual course of an acute

disease or healing of an injury or results from a chronic disease or condition that causes continuous

or intermittent pain over a period of months or years. Unless the context clearly indicates otherwise,

the term intractable pain includes chronic intractable pain.

     (3)(4) "Practitioner" means health care professionals licensed to distribute, dispense, or

administer controlled substances in the course of professional practice as defined in § 21-28-

1.02(41).

     (4)(5) "Therapeutic purpose" means the use of controlled substances for the treatment of

pain in appropriate doses as indicated by the patient's medical record. Any other use is

nontherapeutic.

     5-37.4-3. Controlled substances.

     (a) A practitioner may prescribe, administer, or dispense controlled substances not

prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner for

a condition resulting in intractable pain, if this diagnosis and treatment has been documented in the

practitioner's medical records. No practitioner shall be subject to disciplinary action by the board

solely for prescribing, administering, or dispensing controlled substances when prescribed,

administered, or dispensed for a therapeutic purpose for a person diagnosed and treated by a

practitioner for a condition resulting in intractable pain, if this diagnosis and treatment has been

documented in the practitioner's medical records.

     (b) The provisions of subsection (a) of this section do not apply to those persons being

treated by a practitioner for chemical dependency because of their use of controlled substances not

related to the therapeutic purposes of treatment of intractable pain.

     (c) The provisions of subsection (a) of this section provide no authority to a practitioner to

prescribe, administer, or dispense controlled substances to a person the practitioner knows or should

know to be using the prescribed, administered, or dispensed controlled substance non-

therapeutically.

     (d) Drug dependency or the possibility of drug dependency in and of itself is not a reason

to withhold or prohibit prescribing, administering, or dispensing controlled substances for the

therapeutic purpose of treatment of a person for intractable pain, nor shall dependency relating

solely to this prescribing, administering, or dispensing subject a practitioner to disciplinary action

by the director.

     (e) In coordination with §§ 21-28-3.20 and 21-28-3.20.1, the director of health may

promulgate rules and regulations necessary to effectuate the purpose of this chapter and ensure that

patients with intractable or chronic intractable pain are treated or referred to an appropriate

specialist.

     (f) Nothing in this section shall be construed to prohibit a practitioner or pharmacist from

denying a prescription based on their best clinical judgement.

     (e)(g) Nothing in this section shall deny the right of the director to deny, revoke, or suspend

the license of any practitioner or discipline any practitioner who:

     (1) Prescribes, administers, or dispenses a controlled substance that is nontherapeutic in

nature or nontherapeutic in the manner in which it is prescribed, administered, or dispensed, or fails

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to keep complete and accurate on-going records of the diagnosis and treatment plan;

     (2) Fails to keep complete and accurate records of controlled substances received,

prescribed, dispensed and administered, and disposal of drugs as required by law or of controlled

substances scheduled in the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21

U.S.C. § 801, et seq. A practitioner shall keep records of controlled substances received, prescribed,

dispensed and administered, and disposal of these drugs shall include the date of receipt of the

drugs, the sale or disposal of the drugs by the practitioner, the name and address of the person

receiving the drugs, and the reason for the disposal or the dispensing of the drugs to the person;

     (3) Writes false or fictitious prescriptions for controlled substances as prohibited by law,

or for controlled substances scheduled in the Comprehensive Drug Abuse Prevention and Control

Act of 1970, 21 U.S.C § 801, et seq.; or

     (4) Prescribes, administers, or dispenses in a manner which is inconsistent with provisions

of the law, or the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. §

801, et seq., any controlled substance.

     (f)(h) A practitioner may administer a controlled substance prescribed by a practitioner and

not prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner

for a condition resulting in intractable pain, if this diagnosis and treatment has been documented in

the practitioner's medical records. No practitioner shall be subject to disciplinary action by the

director solely for administering controlled substances when prescribed or dispensed for a

therapeutic purpose for a person diagnosed and treated by a practitioner for a condition resulting in

intractable pain, if this diagnosis and treatment has been documented in the practitioner's medical

records of the patient.

     SECTION 2. Section 21-28-3.20 of the General Laws in Chapter 21-28 entitled "Uniform

Controlled Substances Act" is hereby amended to read as follows:

     21-28-3.20. Authority of practitioner to prescribe, administer, and dispense.

     (a)(1) A practitioner, in good faith and in the course of his or her professional practice only,

may prescribe, administer, and dispense controlled substances, or he or she may cause the

controlled substances to be administered by a nurse or intern under his or her direction and

supervision.

     (2) When issuing an initial prescription for an opiate to an adult patient, a practitioner shall

not exceed the maximum daily dose requirements established by the department of health.

     (3) Except as provided in subsection (a)(4) of this section, a practitioner shall not issue an

opiate prescription to a minor for more than twenty (20) doses at any time. Prior to issuing an opiate

prescription to a minor, a practitioner shall discuss with the parent or guardian of the minor the

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risks associated with opiate use and the reasons why the prescription is necessary. The practitioner

shall document his or her discussion with the parent or guardian in the medical record.

     (4) Notwithstanding the limitations referenced in subsection (a)(3) of this section, if, in the

professional medical judgment of a practitioner, a greater dosage or supply of an opiate is required

to treat the minor patient's acute medical condition or is necessary for the treatment of chronic pain

management, sickle cell related pain, intractable pain treatment as defined in chapter 37.4 of title

5, pain associated with a cancer diagnosis, or for palliative care, then the practitioner may issue a

prescription for the quantity needed to treat the acute medical condition, chronic pain, sickle cell

related pain, intractable pain, pain associated with a cancer diagnosis, or pain experienced while

the patient is in palliative care, provided that this dosage shall not exceed the maximum daily

dosage permitted for the treatment of this pain as set forth in the department of health regulations.

The condition triggering the prescription of an opiate shall be documented in the minor patient's

medical record, and the practitioner shall indicate that a non-opiate alternative was not appropriate

to address the medical condition.

     (5) Notwithstanding subsections (a)(2) and (a)(3) of this section, this section shall not apply

to medications designed for the treatment of substance abuse or opioid dependence.

     (b) The prescription-monitoring program shall be reviewed prior to starting any opioid. A

prescribing practitioner, or designee as authorized by § 21-28-3.32(a)(3), shall review the

prescription-monitoring program prior to refilling or initiating opioid therapy with an intrathecal

pump. For patients the prescribing practitioner is maintaining on continuous opioid therapy for pain

for three (3) months or longer, the prescribing practitioner shall review information from the

prescription-monitoring program at least every three (3) months. Documentation of that review

shall be noted in the patient's medical record.

     (c) The director of health shall develop regulations for prescribing practitioners on

appropriate limits of opioid use in acute pain management. Initial prescriptions of opioids for acute

pain management of outpatient adults shall not exceed thirty (30) morphine milligram equivalents

(MMEs) total daily dose per day for a maximum total of twenty (20) doses, and, for pediatric

patients, the appropriate opioid dosage maximum per the department of health.

     (d) For the purposes of this section, acute pain management shall not include chronic pain

management, pain associated with a cancer diagnosis, palliative or nursing home care, intractable

or chronic intractable pain, as provided in § 5-37.4-2, or other exception in accordance with

department of health regulations.

     (e) Subsection (c) shall not apply to medications designed for the treatment of substance

abuse or opioid dependence.

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     (f) On or before September 1, 2018, the director of health shall develop, and make available

to healthcare practitioners, information on best practices for co-prescribing opioid antagonists to

patients. The best practices information shall identify situations in which co-prescribing an opioid

antagonist may be appropriate, including, but not limited to:

     (1) In conjunction with a prescription for an opioid medication, under circumstances in

which the healthcare practitioner determines the patient is at an elevated risk for an opioid drug

overdose;

     (2) In conjunction with medications prescribed pursuant to a course of medication therapy

management for the treatment of a substance use disorder involving opioids; or

     (3) Under any other circumstances in which a healthcare practitioner identifies a patient as

being at an elevated risk for an opioid drug overdose.

     (g) The best practices information developed pursuant to subsection (f) of this section shall

include guidelines for determining when a patient is at an elevated risk for an opioid drug overdose,

including, but not limited to, situations in which the patient:

     (1) Meets the criteria provided in the opioid overdose toolkit published by the federal

substance abuse and mental health service administration;

     (2) Is receiving high-dose, extended-release, or long-acting opioid medications;

     (3) Has a documented history of an alcohol or substance use disorder, or a mental health

disorder;

     (4) Has a respiratory ailment or other co-morbidity that may be exacerbated by the use of

opioid medications;

     (5) Has a known history of intravenous drug use or misuse of prescription opioids;

     (6) Has received emergency medical care or been hospitalized for an opioid overdose; or

     (7) Uses opioids with antidepressants, benzodiazepines, alcohol, or other drugs.

     (h) On or before September 1, 2018, the director of health and the secretary of the executive

office of health and human services shall develop strategies that include:

     (1) Allowing practitioners in non-pharmacy settings to prescribe and dispense opioid

antagonists; and

     (2) Ensuring that opioid antagonists that are distributed in a non-pharmacy setting are

eligible for reimbursement from any health insurance carrier, as defined under chapters 18, 19, 20,

and 41 of title 27, and the Rhode Island medical assistance program, as defined under chapter 7.2

of title 42.

     SECTION 3. Chapter 21-28 of the General Laws entitled "Uniform Controlled Substances

Act" is hereby amended by adding thereto the following section:

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     21-28-3.20.1. Authority of practitioner to prescribe, administer, and dispense --

Cancer, palliative care and chronic intractable pain.

     (a) A practitioner, in good faith and in the course of his or her professional practice

managing pain associated with a cancer diagnosis, palliative or nursing home care, intractable or

chronic intractable pain as provided in § 5-37.4-2, or other condition allowed by department of

health regulations pursuant to the exception in § 21-28-3.20(d), may prescribe, administer, and

dispense controlled substances without regard to the 2016 CDC Guideline for Prescribing Opioids

for Chronic Pain.

     (b) The director of health may promulgate those rules and regulations necessary to

effectuate the provisions of this section and ensure that rules governing pain management

associated with a cancer diagnosis, palliative or nursing home care, intractable or chronic

intractable pain as provided in § 5-37.4-2, or other condition allowed by department of health

regulations pursuant to the exception created in § 21-28-3.20(d), shall:

     (1) Take into consideration the individualized needs of patients covered by this section;

and

     (2) Make provisions for practitioners, acting in good faith, and in the course of their

profession, and managing pain associated with their patients' illness to use their best judgment

notwithstanding any statute, rule or regulation to the contrary.

     SECTION 4. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT

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     This act would define "chronic intractable pain" for purposes of intractable pain

management. This act would also allow medical practitioners, when dealing with pain management

associated with intractable or chronic pain, to prescribe, administer, and dispense controlled

substances without regard to the 2016 CDC Guidelines for prescribing opioids for chronic pain.

     This act would take effect upon passage.

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