Senate Bill #384 (2021)

AN ACT RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT

Excludes chronic intractable pain from the definition of acute pain management. Prescribes new guidelines for treatment based upon 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.

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Changes since original draft

  • 2021 – S 0384
  • 2021 – S 0384 SUBSTITUTE A
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  • LC001588
  • LC001588/SUB A
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  • S T A T E O F R H O D E I S L A N D
  • S T A T E O F R H O D E I S L A N D
  • IN GENERAL ASSEMBLY
  • JANUARY SESSION, A.D. 2021
  • ____________
  • A N A C T
  • A N A C T
  • RELATING TO FOOD AND DRUGS – UNIFORM CONTROLLED SUBSTANCES ACT
  • Introduced By: SenatorsLawson, Lombardi,Burke, Murray, Euer, Cano, Sosnowski, and
  • Kallman
  • Kallman
  • Date Introduced: February 25, 2021
  • Referred To: Senate Health & Human Services
  • It is enacted by the General Assembly as follows:
  • SECTION1.Sections5-37.4-2and5-37.4-3oftheGeneralLawsinChapter5-37.4entitled "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; produces mental and physical debilitation; and may produce a desire to commit suicide for the sole purpose of stopping the pain. A diagnosis and written documentation of chronic intractable pain made by a physician licensed in the state of Rhode Island shall constitute proof that thepatient suffersfromchronicintractablepain.
  • (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) "Intractablepain" meansa painstatethat persistsbeyond the usual course ofan acute disease or healing of an injury or results from a chronic disease or condition that causes continuous orintermittent painover aperiodofmonthsoryears. Unlessthecontext clearlyindicatesotherwise, 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.
  • (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,ordispensecontrolledsubstancestoapersonthepractitionerknowsorshould 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) Practitioners shall not refuse treatment consistent with federal or state laws, regulations or guidelines for the prescribing of controlled substances under this chapter for the sole reason that a patient requires intensive treatment.
  • (f) 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 with dignity and not unduly denied the medications needed to treat their conditions.
  • (g) Nothing in this section shall be construed to prohibit a practitioner or pharmacist from denying a prescription based on their best clinical judgement.
  • (e)(h) Nothinginthis section shall denytheright ofthedirectorto deny, revoke, orsuspend the license of any practitioner or discipline any practitioner who:
  • (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) Nothinginthis section shall denytheright ofthedirectorto deny, revoke, orsuspend the license of any practitioner or discipline any practitioner who:
  • (1) Prescribes, administers, or dispenses a controlled substance that is nontherapeutic in nature or nontherapeuticinthe manner in which it is prescribed, administered, or dispensed, or fails 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,etseq.Apractitionershall keeprecordsof controlledsubstancesreceived,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)(i) 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.
  • (f)(h) A practitioner mayadminister a controlled substance prescribed bya 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 faithandinthecourse 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 prescriptiontoa minor for more thantwenty(20) doses at anytime. Priortoissuingan 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)Notwithstandingsubsections(a)(2)and(a)(3)ofthissection,thissectionshall 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 prescribingpractitioner ismaintainingon continuous opioidtherapyfor 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)OnorbeforeSeptember1,2018,thedirectorofhealthshall develop,andmakeavailable 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 determiningwhen a patient is at an elevated riskfor an opioid drugoverdose, 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)OnorbeforeSeptember 1,2018,thedirectorofhealthandthesecretaryoftheexecutive 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:
  • 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 controlledsubstances, or he orshe maycause the controlled substances tobe administered by a nurse or intern under his or her direction and supervision without regard to the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.
  • (b) Practitioners, in the course of their professional practice, shall not refuse treatment to patientscoveredunderthissectionforthesolereasonthatthesepatientsrequireintensive treatment.
  • (c) 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;
  • (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; and
  • (3) Ensure that patients covered by this section are treated with dignity and not unduly denied the medications needed to treat their conditions.
  • (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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  • LC001588
  • LC001588/SUB A
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  • EXPLANATION
  • BY THE LEGISLATIVE COUNCIL
  • OF
  • A N A C T
  • RELATING TO FOOD AND DRUGS – UNIFORM CONTROLLED SUBSTANCES ACT
  • ***
  • This act would exclude chronic intractable pain from the definition of "acute pain management", for purposes of prescribing, administering and dispensing controlled substances by a practitioner. The act would prescribe new guidelines for the treatment of "chronic intractable pain" based upon the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.
  • This act would take effect upon passage. ======== LC001588 ========
  • This act would define "chronic intractable pain" for purposes of intractable pain management. This act would also allow medical practitioners, when dealingwith 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. ======== LC001588/SUB A ========

Votes

NOTE: Electronic voting records are unofficial and may not be accurate. For an official vote tally, check the House or Senate Journal from the day of the vote.

Floor vote for Passage

March 30, 2021 at 4:44pm
Yeas: 37 / Nays: 0 / Not voting: 1 / Recused: 0
Legislator Vote
Sen. Acosta Y
Sen. Algiere Y
Sen. Anderson Y
Sen. Archambault Y
Sen. Bell Y
Sen. Burke Y
Sen. Calkin Y
Sen. Cano Y
Sen. Ciccone Y
Sen. Coyne Y
Sen. Cruz Y
Sen. DiMario Y
Sen. DiPalma Y
Sen. Euer NV
Sen. Felag Y
Sen. Gallo Y
Sen. Goldin Y
Sen. Goodwin Y
Sen. Kallman Y
Sen. Lawson Y
Sen. Lombardi Y
Sen. Lombardo Y
Sen. Mack Y
Sen. McCaffrey Y
Sen. Mendes Y
Sen. Miller Y
Sen. Morgan Y
Sen. Murray Y
Sen. Paolino Y
Sen. Pearson Y
Sen. Picard Y
Sen. Quezada Y
Sen. Raptakis Y
Sen. Rogers Y
Sen. Ruggerio Y
Sen. Seveney Y
Sen. Sosnowski Y
Sen. Valverde Y