N.J. Admin. Code § 13:35-7.6

Current through Register Vol. 56, No. 21, November 4, 2024

Section 13:35-7.6 - Limitations on prescribing, administering, or dispensing of controlled dangerous substances; special requirements for management of acute and chronic pain

(a) The following words and terms when used in this section, shall have the following meanings, unless the context clearly indicates otherwise:

"Acute pain" means the pain, whether resulting from disease, accidental or intentional trauma, or other cause, that the practitioner reasonably expects to last only a short period of time. "Acute pain" does not include chronic pain, pain being treated as part of cancer care, hospice or other end of life care, or pain being treated as part of palliative care.

"Chronic pain" means pain that persists or recurs for more than three months.

"Initial prescription" means a prescription issued to a patient who:

1. Has never previously been issued a prescription for the drug or its pharmaceutical equivalent; or

2. Was previously issued a prescription for, or used or was administered the drug or its pharmaceutical equivalent, and the date on which the current prescription is being issued is more than one year after the date the patient last used or was administered the drug or its equivalent. When determining whether a patient was previously issued a prescription for, or used or was administered a drug or its pharmaceutical equivalent, the practitioner shall consult with the patient, review prescription monitoring information, and, to the extent it is available to the practitioner, review the patient's medical record.

"Opioid antidote" means any drug, regardless of dosage amount or method of administration, that has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. "Opioid antidote" includes, but is not limited to, naloxone hydrochloride, in any dosage amount, that is administered through nasal spray or any other FDA-approved means or methods.

"Palliative care" means care provided to an individual suffering from an incurable progressive illness that is expected to end in death, which is designed to decrease the severity of pain, suffering, and other distressing symptoms, and the expected outcome of which is to enable the individual to experience an improved quality of life.

"Practitioner" means an individual currently licensed, registered, or otherwise authorized to prescribe drugs in the course of professional practice, to include a physician, a podiatrist, a physician assistant, and a certified nurse midwife, acting within the scope of practice of his or her professional license or certification.

"Treatment plan" means a memorialization of the objectives by which treatment success is to be evaluated, including, when treating the patient for pain, the specific objectives for pain relief and improved physical and psychological function and any further diagnostic evaluations or other treatments planned, with particular focus on determining the cause of the patient's pain, and when treating chronic pain, the terms of the pain management agreement.

(b) When initiating the prescribing of, the dispensing of, or the administration of controlled dangerous substances, a practitioner shall:

1. Take a thorough medical history of the patient, which reflects the nature, frequency, and severity of any pain, the patient's history of substance use or abuse, and the patient's experience with non-opioid medication and non-pharmacological pain management approaches;

2. Conduct a physical examination appropriate to the standard of care relating to the patient's condition, including an assessment of physical and psychological function, and an evaluation of underlying or coexisting physical and psychological diseases or conditions, including anxiety and depression;

3. Make a reasonable effort to obtain and review the patient's medical record;

4. Determine, when treating the patient's pain, if the patient was previously issued a prescription for, used, or was administered a drug or its pharmaceutical equivalent. The practitioner may make this determination by reviewing the patient's medical record, if available, reviewing the patient's prescription monitoring information, or consulting with the patient;

5. Access relevant prescription monitoring information as maintained by the Prescription Monitoring Program (PMP) pursuant to N.J.S.A. 45:1-46.1 and consider that information in accordance with N.J.A.C. 13:45A-35;

6. Develop a treatment plan; and

7. Prepare a medical record, which includes the:

i. Medical history;

ii. Findings on examination;

iii. Relevant PMP data;

iv. Efforts made to obtain the patient's medical records;

v. Treatment plan; and

vi. Medications prescribed, dispensed, or administered, including:

(1) The complete name of the controlled substance;

(2) The dosage, strength, and quantity of the controlled substance; and

(3) The instructions as to frequency of use.

(c) With respect to Schedule II controlled dangerous substances, unless the requirements of this subsection are met or the prescribing of opioids is subject to limitations as set forth at (g) below, a practitioner may authorize a quantity, not to exceed a 30-day supply, which shall be at the lowest effective dose as determined by the directed dosage and frequency of dosage. The prescribing of opioids in any schedule is subject to limitations as set forth at (g) below.

1. Notwithstanding the 30-day supply limitation, a practitioner may prescribe the use of an implantable infusion pump that is utilized to achieve pain management for patients suffering from cancer, intractable pain, or terminal illness. A prescription for such an implantable infusion pump may provide up to a 90-day supply, as long as the physician evaluates and documents the patient's continued need at least every 30 days; and

2. Notwithstanding the 30-day supply limitation, a physician may prescribe multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled dangerous substance provided that:

i. Each separate prescription is issued for a legitimate medical purpose by the practitioner acting in the usual course of professional practice;

ii. The practitioner provides written instructions on each prescription, other than the first prescription if it is to be filled immediately, indicating the earliest date on which a pharmacy may fill each prescription;

iii. The practitioner determines that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;

iv. The practitioner evaluates the benefits and harms of opioid therapy when treating a patient for pain, and determines that clinically meaningful improvement in pain and function outweigh the risks to patient safety; and

v. The practitioner complies with all other applicable State and Federal laws and regulations.

(d) Prior to issuing an initial prescription for a Schedule II controlled dangerous substance or any opioid drug in the course of treatment for acute pain, a practitioner shall discuss with the patient, or the patient's parent or guardian if the patient is under 18 years of age and is not an emancipated minor, the reasons why the medication is being prescribed, the treatment plan, including the objectives to be accomplished with the medication, the possible alternative treatments, and the risks associated with the medication. With respect to opioid drugs, the discussion shall include, but not be limited to, the risks of addiction, including that opioids are highly addictive, even when taken as prescribed and used as directed, physical or psychological dependence, and overdose associated with opioid drugs and the danger of taking opioid drugs with alcohol, benzodiazepines, and other central nervous system depressants, and requirements for proper storage and disposal.

1. If the patient is under 18 years of age and is not an emancipated minor, the practitioner shall have the discussion required under (d) above prior to the issuance of each subsequent prescription for any opioid drug that is a Schedule II controlled dangerous substance.

2. The practitioner shall reiterate the discussion required in (d) above prior to issuing a prescription at the outset of a course of treatment for chronic pain for a Schedule II controlled dangerous substance or any opioid drug.

3. The practitioner shall include a note in the patient record that the required discussion(s) took place.

(e) Prior to the commencement of an ongoing course of treatment for chronic pain with a Schedule II controlled dangerous substance or any opioid, the practitioner shall enter into a pain management agreement with the patient. The pain management agreement shall be a written contract or agreement that is executed between a practitioner and a patient, that is signed and dated prior to the commencement of an ongoing course of treatment for chronic pain using a Schedule II controlled dangerous substance or any opioid drug, and which shall:

1. Document the understanding of both the practitioner and the patient regarding the patient's treatment plan, taking into account the patient's history since being initiated on opioids, current progress toward objectives in the treatment plan, and modified treatment objectives, as appropriate, and in accordance with the standard of care;

2. Establish the patient's rights in association with treatment, and the patient's obligations in relation to the responsible use, discontinuation of use, and storage and disposal of Schedule II controlled dangerous substances and any opioid drugs, including any restrictions on the refill or acceptance of such prescriptions from practitioners and other prescribers;

3. Identify the specific medications and other modes of treatment, including physical therapy or exercise, relaxation, or psychological counseling, that are included as part of the treatment plan;

4. Specify the measures the practitioner may employ to monitor the patient's compliance including, but not limited to, random specimen screens and pill counts; and

5. Delineate the process for terminating the agreement, including the consequences if the practitioner has reason to believe that the patient is not complying with the terms of the agreement.

(f) When controlled dangerous substances are continuously prescribed for management of chronic pain, the practitioner shall:

1. Review, at a minimum of every three months, the course of treatment, any new information about the etiology of the pain, and the patient's progress toward treatment objectives, and discuss with the patient the course of treatment and progress toward objectives in the treatment plan and document the results of that review;

2. Assess the patient prior to issuing each prescription to determine whether the patient is experiencing problems associated with physical and psychological dependence, and document the results of that assessment;

3. Make periodic reasonable efforts, unless clinically contraindicated, to either stop the use of the controlled dangerous substance, taper the dosage, try other drugs, such as nonsteroidal anti-inflammatories, or utilize alternative treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence, and document, with specificity, the efforts undertaken;

4. Discontinue (through tapering, if necessary) opioid therapy, in accordance with the standard of care if there is insufficient clinically meaningful improvement in pain and function;

6. Monitor compliance with the pain management agreement and continue to assess whether the patient's improvement in pain and function outweigh risks to patient safety;

7. Monitor compliance with any recommendations that the patient seek a referral;

8. Discuss with the patient any breaches that reflect that the patient is not taking the drugs as prescribed, is taking illicit drugs, or is taking other prescribed drugs without informing the practitioner, and document within the patient record the plan after that discussion;

9. Conduct random urine screens at least once every 12 months;

10. Advise the patient, or the patient's parent or guardian if the patient is under 18 years of age and is not an emancipated minor, of the availability of an opioid antidote; and

11. Refer the patient to a pain management or addiction specialist for independent evaluation or treatment if the patient is not attaining clinically meaningful improvement in pain and function, in accordance with the treatment plan.

(g) A practitioner shall not issue an initial prescription for an opioid drug for treatment of acute pain in a quantity exceeding a five-day supply as determined by the directed dosage and frequency of dosage. The initial prescription shall be for the lowest effective dose of an immediate-release opioid drug. A practitioner shall not issue an initial prescription for an opioid drug that is for an extended-release or long-acting opioid. No less than four days after issuing the initial prescription, upon request of the patient, a practitioner may issue a subsequent prescription for an opioid drug for the continued treatment of acute pain associated with the condition that necessitated the initial prescription provided the following conditions are met:

1. The practitioner consults (in person, via telephone, or other means of direct communication) with the patient;

2. After the consultation with the patient and consideration of the treatment plan, the practitioner, in the exercise of his or her professional judgment, determines that an additional days' supply of the prescribed opioid drug is necessary and appropriate to the patient's treatment needs and does not present an undue risk of abuse, addiction, or diversion and is consistent with the treatment plan;

3. The practitioner documents the rationale for the authorization in the patient record;

4. The subsequent prescription for an additional days' supply of the prescribed opioid drug is tailored to the patient's expected need at the stage of recovery, as determined under (g)2 above and any subsequent prescription for an additional days' supply shall not exceed a 30-day supply, unless authorized pursuant to (c) above.

5. When a patient is prescribed a course of opioid treatment that is to last more than 35 days, the practitioner shall discuss with the patient an exit strategy consistent with the standard of care for the discontinuation of opioids in the event they are not providing clinically meaningful improvement in pain or function, and shall modify the treatment plan to include the exit strategy; and

6. The practitioner shall include a note in the record that the exit strategy discussion required at (g)5 above, took place.

(h) When a practitioner issues an initial prescription for an opioid drug for the treatment of acute pain, the practitioner shall so indicate it on the prescription.

(i) Except as provided at (i)1 below, when a practitioner issues a patient a prescription for an opioid drug that is a controlled dangerous substance, the practitioner shall also issue the patient a prescription for an opioid antidote when the patient has a history of substance use disorder, the prescription for the opioid drug is for a daily dose of more than 90 morphine milligram equivalents, or the patient holds a current, valid prescription for a benzodiazepine drug that is a Schedule III or Schedule IV controlled dangerous substance.

1. A practitioner shall not be required to issue more than one prescription for an opioid antidote to a patient per year.

2. Nothing at (i)1 above shall be construed to prohibit a practitioner from issuing additional prescriptions for an opioid antidote to a patient upon the patient's request or when the practitioner determines there is a clinical or practical need for the additional prescription.

(j) The requirements for prescribing controlled dangerous substances set forth at (d) through (i) above shall not apply to a prescription for a patient who is currently in active treatment for cancer, receiving hospice care from a licensed hospice, receiving palliative care, or is a resident of a longterm care facility, or to any medications that are being prescribed for use in the treatment of substance abuse or opioid dependence.

(k) Nothing in (g) above shall be construed to limit a practitioner's professional judgment to authorize a subsequent prescription for an opioid drug in a quantity consistent with (g)4 above for the continued treatment of acute pain associated with the condition that necessitated the initial prescription.

N.J. Admin. Code § 13:35-7.6

Amended by 49 N.J.R. 1433(a), effective 6/5/2017

Amended by 53 N.J.R. 124(c), effective 1/19/2021

Amended by 55 N.J.R. 110(b), effective 1/17/2023