2020 -- H 7398 | |
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LC003605 | |
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STATE OF RHODE ISLAND | |
IN GENERAL ASSEMBLY | |
JANUARY SESSION, A.D. 2020 | |
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A N A C T | |
RELATING TO FOOD AND DRUGS -- UNIFORM CONTROLLED SUBSTANCES ACT | |
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Introduced By: Representatives Amore, Serodio, O'Brien, Kazarian, and Blazejewski | |
Date Introduced: January 31, 2020 | |
Referred To: House Health, Education & Welfare | |
It is enacted by the General Assembly as follows: | |
1 | SECTION 1. Sections 5-37.4-2 and 5-37.4-3 of the General Laws in Chapter 5-37.4 |
2 | entitled "Intractable Pain Treatment" are hereby amended to read as follows: |
3 | 5-37.4-2. Definitions. |
4 | For purposes of this chapter: |
5 | (1) "Chronic intractable pain" means pain that is: excruciating; constant; incurable, and of |
6 | such severity that it dominates virtually every conscious moment; produces mental and physical |
7 | debilitation; and may produce a desire to commit suicide for the sole purpose of stopping the |
8 | pain. A diagnosis and written documentation of chronic intractable pain made by a physician |
9 | licensed in the state of Rhode Island shall constitute proof that the patient suffers from chronic |
10 | intractable pain. |
11 | (1)(2) "Director" means the director of the department of health of the state of Rhode |
12 | Island. |
13 | (2)(3) "Intractable pain" means a pain state that persists beyond the usual course of an |
14 | acute disease or healing of an injury or results from a chronic disease or condition that causes |
15 | continuous or intermittent pain over a period of months or years. Unless the context clearly |
16 | indicates otherwise, the term intractable pain includes chronic intractable pain. |
17 | (3)(4) "Practitioner" means health care professionals licensed to distribute, dispense, or |
18 | administer controlled substances in the course of professional practice as defined in § 21-28- |
19 | 1.02(41). |
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1 | (4)(5) "Therapeutic purpose" means the use of controlled substances for the treatment of |
2 | pain in appropriate doses as indicated by the patient's medical record. Any other use is |
3 | nontherapeutic. |
4 | 5-37.4-3. Controlled substances. |
5 | (a) A practitioner may prescribe, administer, or dispense controlled substances not |
6 | prohibited by law for a therapeutic purpose to a person diagnosed and treated by a practitioner for |
7 | a condition resulting in intractable pain, if this diagnosis and treatment has been documented in |
8 | the practitioner's medical records. No practitioner shall be subject to disciplinary action by the |
9 | board solely for prescribing, administering, or dispensing controlled substances when prescribed, |
10 | administered, or dispensed for a therapeutic purpose for a person diagnosed and treated by a |
11 | practitioner for a condition resulting in intractable pain, if this diagnosis and treatment has been |
12 | documented in the practitioner's medical records. |
13 | (b) The provisions of subsection (a) of this section do not apply to those persons being |
14 | treated by a practitioner for chemical dependency because of their use of controlled substances |
15 | not related to the therapeutic purposes of treatment of intractable pain. |
16 | (c) The provisions of subsection (a) of this section provide no authority to a practitioner |
17 | to prescribe, administer, or dispense controlled substances to a person the practitioner knows or |
18 | should know to be using the prescribed, administered, or dispensed controlled substance non- |
19 | therapeutically. |
20 | (d) Drug dependency or the possibility of drug dependency in and of itself is not a reason |
21 | to withhold or prohibit prescribing, administering, or dispensing controlled substances for the |
22 | therapeutic purpose of treatment of a person for intractable pain, nor shall dependency relating |
23 | solely to this prescribing, administering, or dispensing subject a practitioner to disciplinary action |
24 | by the director. |
25 | (e) Practitioners shall not refuse treatment consistent with federal or state laws, |
26 | regulations or guidelines for the prescribing of controlled substances under this chapter for the |
27 | sole reason that a patient requires intensive treatment. |
28 | (f) In coordination with §§ 21-28-3.20 and 21-28-3.20.1, the director of health may |
29 | promulgate rules and regulations necessary to effectuate the purpose of this chapter and ensure |
30 | that patients with intractable or chronic intractable pain are treated with dignity and not unduly |
31 | denied the medications needed to treat their conditions. |
32 | (g) Nothing in this section shall be construed to prohibit a practitioner or pharmacist from |
33 | denying a prescription based on their best clinical judgement. |
34 | (e)(h) Nothing in this section shall deny the right of the director to deny, revoke, or |
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1 | suspend the license of any practitioner or discipline any practitioner who: |
2 | (1) Prescribes, administers, or dispenses a controlled substance that is nontherapeutic in |
3 | nature or nontherapeutic in the manner in which it is prescribed, administered, or dispensed, or |
4 | fails to keep complete and accurate on-going records of the diagnosis and treatment plan; |
5 | (2) Fails to keep complete and accurate records of controlled substances received, |
6 | prescribed, dispensed and administered, and disposal of drugs as required by law or of controlled |
7 | substances scheduled in the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 |
8 | U.S.C. § 801, et seq. A practitioner shall keep records of controlled substances received, |
9 | prescribed, dispensed and administered, and disposal of these drugs shall include the date of |
10 | receipt of the drugs, the sale or disposal of the drugs by the practitioner, the name and address of |
11 | the person receiving the drugs, and the reason for the disposal or the dispensing of the drugs to |
12 | the person; |
13 | (3) Writes false or fictitious prescriptions for controlled substances as prohibited by law, |
14 | or for controlled substances scheduled in the Comprehensive Drug Abuse Prevention and Control |
15 | Act of 1970, 21 U.S.C § 801, et seq.; or |
16 | (4) Prescribes, administers, or dispenses in a manner which is inconsistent with |
17 | provisions of the law, or the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 |
18 | U.S.C. § 801, et seq., any controlled substance. |
19 | (f)(i) A practitioner may administer a controlled substance prescribed by a practitioner |
20 | and not prohibited by law for a therapeutic purpose to a person diagnosed and treated by a |
21 | practitioner for a condition resulting in intractable pain, if this diagnosis and treatment has been |
22 | documented in the practitioner's medical records. No practitioner shall be subject to disciplinary |
23 | action by the director solely for administering controlled substances when prescribed or dispensed |
24 | for a therapeutic purpose for a person diagnosed and treated by a practitioner for a condition |
25 | resulting in intractable pain, if this diagnosis and treatment has been documented in the |
26 | practitioner's medical records of the patient. |
27 | SECTION 2. Section 21-28-3.20 of the General Laws in Chapter 21-28 entitled "Uniform |
28 | Controlled Substances Act" is hereby amended to read as follows: |
29 | 21-28-3.20. Authority of practitioner to prescribe, administer, and dispense. |
30 | (a)(1) A practitioner, in good faith and in the course of his or her professional practice |
31 | only, may prescribe, administer, and dispense controlled substances, or he or she may cause the |
32 | controlled substances to be administered by a nurse or intern under his or her direction and |
33 | supervision. |
34 | (2) When issuing an initial prescription for an opiate to an adult patient, a practitioner |
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1 | shall not exceed the maximum daily dose requirements established by the department of health. |
2 | (3) Except as provided in subsection (a)(4) of this section, a practitioner shall not issue an |
3 | opiate prescription to a minor for more than twenty (20) doses at any time. Prior to issuing an |
4 | opiate prescription to a minor, a practitioner shall discuss with the parent or guardian of the minor |
5 | the risks associated with opiate use and the reasons why the prescription is necessary. The |
6 | practitioner shall document his or her discussion with the parent or guardian in the medical |
7 | record. |
8 | (4) Notwithstanding the limitations referenced in subsection (a)(3) of this section, if, in |
9 | the professional medical judgment of a practitioner, a greater dosage or supply of an opiate is |
10 | required to treat the minor patient's acute medical condition or is necessary for the treatment of |
11 | chronic pain management, sickle cell related pain, intractable pain treatment as defined in chapter |
12 | 37.4 of title 5, pain associated with a cancer diagnosis, or for palliative care, then the practitioner |
13 | may issue a prescription for the quantity needed to treat the acute medical condition, chronic pain, |
14 | sickle cell related pain, intractable pain, pain associated with a cancer diagnosis, or pain |
15 | experienced while the patient is in palliative care, provided that this dosage shall not exceed the |
16 | maximum daily dosage permitted for the treatment of this pain as set forth in the department of |
17 | health regulations. The condition triggering the prescription of an opiate shall be documented in |
18 | the minor patient's medical record, and the practitioner shall indicate that a non-opiate alternative |
19 | was not appropriate to address the medical condition. |
20 | (5) Notwithstanding subsections (a)(2) and (a)(3) of this section, this section shall not |
21 | apply to medications designed for the treatment of substance abuse or opioid dependence. |
22 | (b) The prescription-monitoring program shall be reviewed prior to starting any opioid. A |
23 | prescribing practitioner, or designee as authorized by § 21-28-3.32(a)(3), shall review the |
24 | prescription-monitoring program prior to refilling or initiating opioid therapy with an intrathecal |
25 | pump. For patients the prescribing practitioner is maintaining on continuous opioid therapy for |
26 | pain for three (3) months or longer, the prescribing practitioner shall review information from the |
27 | prescription-monitoring program at least every three (3) months. Documentation of that review |
28 | shall be noted in the patient's medical record. |
29 | (c) The director of health shall develop regulations for prescribing practitioners on |
30 | appropriate limits of opioid use in acute pain management. Initial prescriptions of opioids for |
31 | acute pain management of outpatient adults shall not exceed thirty (30) morphine milligram |
32 | equivalents (MMEs) total daily dose per day for a maximum total of twenty (20) doses, and, for |
33 | pediatric patients, the appropriate opioid dosage maximum per the department of health. |
34 | (d) For the purposes of this section, acute pain management shall not include chronic pain |
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1 | management, pain associated with a cancer diagnosis, palliative or nursing home care, intractable |
2 | or chronic intractable pain, as provided in § 5-37.4-2, or other exception in accordance with |
3 | department of health regulations. |
4 | (e) Subsection (c) shall not apply to medications designed for the treatment of substance |
5 | abuse or opioid dependence. |
6 | (f) On or before September 1, 2018, the director of health shall develop, and make |
7 | available to healthcare practitioners, information on best practices for co-prescribing opioid |
8 | antagonists to patients. The best practices information shall identify situations in which co- |
9 | prescribing an opioid antagonist may be appropriate, including, but not limited to: |
10 | (1) In conjunction with a prescription for an opioid medication, under circumstances in |
11 | which the healthcare practitioner determines the patient is at an elevated risk for an opioid drug |
12 | overdose; |
13 | (2) In conjunction with medications prescribed pursuant to a course of medication |
14 | therapy management for the treatment of a substance use disorder involving opioids; or |
15 | (3) Under any other circumstances in which a healthcare practitioner identifies a patient |
16 | as being at an elevated risk for an opioid drug overdose. |
17 | (g) The best practices information developed pursuant to subsection (f) of this section |
18 | shall include guidelines for determining when a patient is at an elevated risk for an opioid drug |
19 | overdose, including, but not limited to, situations in which the patient: |
20 | (1) Meets the criteria provided in the opioid overdose toolkit published by the federal |
21 | substance abuse and mental health service administration; |
22 | (2) Is receiving high-dose, extended-release, or long-acting opioid medications; |
23 | (3) Has a documented history of an alcohol or substance use disorder, or a mental health |
24 | disorder; |
25 | (4) Has a respiratory ailment or other co-morbidity that may be exacerbated by the use of |
26 | opioid medications; |
27 | (5) Has a known history of intravenous drug use or misuse of prescription opioids; |
28 | (6) Has received emergency medical care or been hospitalized for an opioid overdose; or |
29 | (7) Uses opioids with antidepressants, benzodiazepines, alcohol, or other drugs. |
30 | (h) On or before September 1, 2018, the director of health and the secretary of the |
31 | executive office of health and human services shall develop strategies that include: |
32 | (1) Allowing practitioners in non-pharmacy settings to prescribe and dispense opioid |
33 | antagonists; and |
34 | (2) Ensuring that opioid antagonists that are distributed in a non-pharmacy setting are |
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1 | eligible for reimbursement from any health insurance carrier, as defined under chapters 18, 19, |
2 | 20, and 41 of title 27, and the Rhode Island medical assistance program, as defined under chapter |
3 | 7.2 of title 42. |
4 | SECTION 3. Chapter 21-28 of the General Laws entitled "Uniform Controlled |
5 | Substances Act" is hereby amended by adding thereto the following section: |
6 | 21-28-3.20.1. Authority of practitioner to prescribe, administer, and dispense -- |
7 | Cancer, palliative care and chronic intractable pain. |
8 | (a) A practitioner, in good faith and in the course of his or her professional practice |
9 | managing pain associated with a cancer diagnosis, palliative or nursing home care, intractable or |
10 | chronic intractable pain as provided in § 5-37.4-2, or other condition allowed by department of |
11 | health regulations pursuant to the exception in § 21-28-3.20(d), may prescribe, administer, and |
12 | dispense controlled substances, or he or she may cause the controlled substances to be |
13 | administered by a nurse or intern under his or her direction and supervision without regard to the |
14 | 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. |
15 | (b) Practitioners, in the course of their professional practice, shall not refuse treatment to |
16 | patients covered under this section for the sole reason that these patients require intensive |
17 | treatment. |
18 | (c) The director of health may promulgate those rules and regulations necessary to |
19 | effectuate the provisions of this section and ensure that rules governing pain management |
20 | associated with a cancer diagnosis, palliative or nursing home care, intractable or chronic |
21 | intractable pain as provided in § 5-37.4-2, or other condition allowed by department of health |
22 | regulations pursuant to the exception created in § 21-28-3.20(d), shall: |
23 | (1) Take into consideration the individualized needs of patients covered by this section; |
24 | (2) Make provisions for practitioners, acting in good faith, and in the course of their |
25 | profession, and managing pain associated with their patients' illness to use their best judgment |
26 | notwithstanding any statute, rule or regulation to the contrary; and |
27 | (3) Ensure that patients covered by this section are treated with dignity and not unduly |
28 | denied the medications needed to treat their conditions. |
29 | 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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1 | This act would exclude chronic intractable pain from the definition of "acute pain |
2 | management", for purposes of prescribing, administering and dispensing controlled substances by |
3 | a practitioner. The act would prescribe new guidelines for the treatment of "chronic intractable |
4 | pain" based upon the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. |
5 | This act would take effect upon passage. |
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