Chapter 037
2021 -- H 5247 SUBSTITUTE A
Enacted 06/02/2021

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

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 healthcare 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 judgment.
     (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
to keep complete and accurate on-going ongoing 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
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.
     (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:
     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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LC000175/SUB A
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