State of New Jersey | Department of Law & Public Safety

Matthew J. Platkin, Attorney General

Clinicians

NJ CARES

A Dashboard of Opioid-Related Data and Information

Kelly E. Levy,
Acting Director

Clinicians

  • The Prescription Monitoring Program
  • The “5-Day Rule” & Other Rules for Pain Management
  • Co-Prescribing Naloxone
  • DATA-Waiver Program Eliminated
  • Prescribing Schedule II CDS through Telemedicine or Telehealth
  • Continuing Education on Opioids
  • Additional Resources

The Prescription Monitoring Program[1]

Before prescribing any controlled dangerous substance (CDS), practitioners are required to access a statewide electronic database called the New Jersey Prescription Monitoring Program (PMP) to review a patient’s prescription history and risk alerts as follows:

  • The first time they prescribe any Schedule II medication or any opioid for acute or chronic pain, or a Schedule III or IV benzodiazepine;[2]
  • Every 3 months thereafter, if continuing to prescribe one of the above;[3]
  • Any time the patient appears to be seeking CDS for any purpose other than the treatment of an existing medical condition (e.g., misuse, abuse, or diversion);[4] and
  • Any time the practitioner prescribes a Schedule II CDS for acute or chronic pain to a patient receiving care or treatment in the emergency department of a general hospital.[5]

Here, “practitioner” means someone “currently licensed, registered, or otherwise authorized by this State or another state to prescribe drugs in the course of professional practice.” See N.J.S.A. 45:1-44.

Patient information in the PMP is intended to supplement a patient evaluation, confirm a patient’s drug history, and document compliance with a therapeutic regimen.[6]  When practitioners identify a patient as potentially having an issue of concern regarding drug use, they are encouraged to help the patient locate assistance and take any other action they deem appropriate.[7]

For FAQ about the PMP, click here.

The “5-Day Rule”[8] & Other Rules for Pain Management[9]

When issuing an initial prescription for a Schedule II CDS or any opioid for patients who suffer from acute pain,[10] the prescriber must:

  • Take and document the results of a thorough medical history, including the patient’s experience with non-opioid medication and non-pharmacological pain management approaches and substance abuse history;[11]
  • Conduct, as appropriate, a physical examination and document the results;[12]
  • Develop a treatment plan, with particular attention focused on determining the cause of the patient’s pain;[13]
  • Access the PMP;[14]
  • Limit the prescription to no more than a 5-day supply at the lowest effective dose of an immediate-release formulation;[15] and
  • Discuss the reasons why the medication is being prescribed, the treatment plan, including the objectives to be accomplished with the medication, possible alternative treatments, and the risks associated with the medication.[16]

If, after the initial 5-day prescription, the patient requests a subsequent opioid prescription, the prescriber must:

  • Wait until at least the 4th day from the date of the initial prescription;[17]
  • Determine, after a consultation, in-person or by telephone, whether an additional supply is necessary and does not present an undue risk of abuse, addiction, or diversion, and is consistent with the treatment plan; [18] and
  • Tailor the supply to the patient’s need, and never provide more than a 30-day supply.[19]

When prescribing opioids to a patient for chronic pain,[20] a practitioner must:

  • Enter into a pain management agreement[21] with the patient;[22]
  • Take and document the results of a thorough medical history, including the patient’s experience with non-opioid medication and non-pharmacological pain management approaches and substance abuse history;[23]
  • Conduct, as appropriate, a physical examination and document the results ;[24]
  • Review, 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;[25]
  • Reassess treatment goals and make reasonable periodic efforts to taper or stop prescribing opioids, in accordance with the standard of care, if there is insufficient clinically meaningful improvement in pain and function;[26]
  • 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;[27]
  • Discuss with the patient any breaches that reflect the patient is not taking the drugs as prescribed;[28]
  • Conduct random urine screens at least once every 12 months;[29]
  • Advise the patient of the availability of an opioid antidote;[30] and
  • Refer the patient to a pain management or addiction specialist if the patient is not attaining clinically meaningful improvement in accordance with the treatment plan.[31]

The above requirements in this section (“The 5-Day Rule & Other Rules for Pain Management”) do not apply if:  (a) the prescription is being issued to a patient being treated for cancer, receiving hospice care from a licensed hospice, receiving palliative care, or residing in long term care facility, or (b) the prescription is for treatment of substance use disorder, or (c) if medications are being administered pursuant to medication orders in in-patient facilities.[32]

For guidelines from the New Jersey Division of Consumer Affairs on what practitioners should discuss with their patients when prescribing Schedule II CDS or any other opioid drugs, click here.

For FAQ about limitations on prescribing opioids for acute and chronic pain, click here.

Prescribing Schedule II CDS through Telemedicine or Telehealth

The prescription of Schedule II CDS through the use of telemedicine[33] or telehealth[34] shall be authorized only after an initial in-person examination of the patient, as provided by regulation[35], and a subsequent in-person visit with the patient shall be required every 3 months for the duration of time that the patient is being prescribed the Schedule II CDS.[36]

An exception to the in-person examination and three-month reviews for Schedule II CDS prescriptions exists when all of the following conditions are met: (1) the Schedule II CDS is a stimulant being issued for a patient under the age of 18 years; (2) the licensee is using interactive, real-time, two-way audio and video technologies; and (3) the licensee has obtained written consent for a waiver of in-person examination requirements from the patient’s parent or guardian.[37]

Co-Prescribing Naloxone[38]

In New Jersey, a practitioner who issues a prescription for an opioid that is a CDS must also give the patient a prescription for an opioid antidote when any of the following conditions are present:

  • 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 CDS.[39]

Practitioners do not need to co-prescribe an opioid antidote to a patient who is currently in active treatment for cancer, receiving hospice care from a licensed hospice, receiving palliative care, or residing in a long-term care facility.[40]  Nor do practitioners need to co-prescribe an opioid antidote when prescribing medication for treatment of substance abuse, or opioid dependence.[41]

For FAQ about co-prescribing naloxone to patients with heightened risk of opioid overdose, click here.

DATA-Waiver Program Eliminated:   An X Waiver is No Longer Required to Treat Opioid Use Disorder

Historically, the Drug Addiction Treatment Act of 2000 (DATA) mandated that clinicians who wanted to treat patients with buprenorphine outside of an opioid treatment program (OTP) had to first obtain express approval after completing a DATA-Waiver program.   Clinicians who successfully registered for the DATA-Waiver program and completed certain training requirements had the letter “X” appended to their Drug Enforcement Administration (DEA) license number.   Hence, the DATA-Waiver became known as the “X Waiver.”

On December 29, 2022, Congress eliminated the DATA-Waiver Program.  Now, all practitioners who have a current DEA registration that includes Schedule III authority may prescribe buprenorphine for opioid use disorder.  The DEA and the Substance Abuse and Mental Health Services Administration (SAMSHA) issued guidance on the removal of the X-waiver.  In so doing, the DEA Administrator noted: “The elimination of the X-Waiver will increase access to buprenorphine for those in need.”[42]  As stated in the guidance:

  • A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
  • Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
  • There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.[43]

For FAQ about the elimination of the X-Waiver, click here.

Instead of specialized training imposed only on clinicians specifically seeking to prescribe buprenorphine, there is now a one-time, 8-hour training requirement on the treatment and management of patients with opioid use disorder or other substance use disorders for all practitioners, except veterinarians, seeking to renew their DEA registrations or applying for new DEA registrations.  For more information about the training requirement, click here.

For a video from the DEA explaining the training requirement, click here.

Further, the Centers for Excellence have a 24/7 Hotline – 844-HELP-OUD – for health care practitioners to call with questions about medications for opioid use disorder at any time.  For more information, click here.

Continuing Medical Education (CME) on Opioids

Rowan-Virtua School of Osteopathic Medicine (Rowan-Virtua SOM), in partnership with NJ CARES and the New Jersey Division of Consumer Affairs, has developed several no-cost educational opportunities for health care professionals with prescribing authority, including:

  • New Jersey Academic Detailing Program: an interactive outreach program where trained program staff are available to engage with New Jersey healthcare professionals with opioid prescribing authority in a one-on-one dialogue to assess individual prescriber needs and the needs of their practice, and then offer tailored, evidence-based clinical recommendations and education. The program includes:
    • clinicians with expertise in opioid prescribing who are available to meet with New Jersey healthcare professionals during one-hour virtual meetings that are customized to meet the provider’s needs;
    • virtual clinical case studies related to opioid prescribing, pain and/or opioid use disorder; and
    • educational materials which promote evidence-based clinical recommendations in opioid prescribing.

To schedule an academic detailing session with trained program staff from Rowan-Virtua SOM, click here.  To register for the virtual case studies, click here.  For more information on the New Jersey Academic Detailing Program and available resources, click here.

  • New Jersey Open Dialogue with Experts Opioid Education Podcast Series: a recorded Podcast series providing standardized, comprehensive, easily accessible, evidence-based education on the best practices regarding opioids for professionals throughout the State.

To register to view 18 recorded video podcast interviews featuring experts in their respective fields, click here.

Additionally, the Partnership for a Drug-Free New Jersey, in partnership with NJ CARES and the American Academy of CME, Inc., developed the Knock Out Opioid Abuse Day Learning Series, a live monthly webinar series that aims to educate the public on various topics related to the opioid epidemic.   To register for upcoming webinars or to learn more, click here.

Additional Resources

[1]              See N.J.S.A. 45:1-46.1(a)(1); N.J.A.C. 13:45A-35.1 to .12; see also NJ Division of Consumer Affairs, “NJ Monitoring Program.” (https://www.njconsumeraffairs.gov/pmp/Pages/default.aspx)
[2]              See N.J.S.A. 45:1-46.1(a)(1)(a)&(b); N.J.A.C. 13:45A-35.9(a)(1)&(2).
[3]              See N.J.S.A. 45:1-46.1(a)(1); N.J.A.C. 13:45A-35.9(a)(5).
[4]              See N.J.S.A. 45:1-46.1(a)(1)(c); N.J.A.C. 13:45A-35.9(a)(3).
[5]              See N.J.S.A. 45:1-46.1(a)(1)(d); N.J.A.C. 13:45A-35.9(a)(4).   To see a list of exceptions to the PMP’s mandatory look-up requirements, see N.J.S.A. 45:1-46.1(b).
[6]              See NJ Division of Consumer Affairs, “Prescribing Opioids in New Jersey.” (https://www.njconsumeraffairs.gov/dcu/Documents/Prescribing-Opioids-in-NJ.pdf)
[7]              See id.
[8]              See N.J.S.A. 24:21-15.2(a)&(b); N.J.A.C. 13:35-7.6(g).
[9]              See N.J.S.A. 24:21-15.2(b); N.J.A.C. 13:35-7.6(b),(c),(e)&(f).
[10]             “Acute pain” means pain, whether resulting from disease, accidental or intentional trauma, or other cause, which the practitioner reasonably expects to last only a short period of time.  See N.J.S.A. 24:21-15.2(g).  It 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. Id.
[11]             See N.J.S.A. 24:21-15.2(b).
[12]             See id.
[13]             See id.
[14]             See id.
[15]             See N.J.S.A. 24:21-15.2(a)&(b); N.J.A.C. 13:35-7.6(g)
[16]             See N.J.S.A. 24:21-15.2(d); N.J.A.C. 13:35-7.6(d) (With respect to opioid drugs, the discussion must include, but not be limited to, the fact that opioids are highly addictive even when used as directed; risks of physical dependence, psychological dependence, and overdose; dangers of taking opioids with alcohol, benzodiazepines, and other central nervous system depressants; and requirements for proper storage and disposal).
[17]             See N.J.S.A. 24:21-15.2(c); N.J.A.C. 13:35-7.6(g)(2).
[18]             See N.J.S.A. 24:21-15.2(c); N.J.A.C. 13:35-7.6(g)(2).
[19]             See N.J.A.C. 13:35-7.6(g)(4).
[20]             Pursuant to N.J.S.A. 24:21-15.2(g), “’Chronic pain’ means pain that persists or recurs for more than three months.”
[21]             Pursuant to N.J.S.A. 24:21-15.2(g), “Pain management agreement” means:

a written contract or agreement that is executed between a practitioner and a patient, prior to the commencement of treatment for chronic pain using a Schedule II controlled dangerous substance or any other opioid drug which is a prescription drug as defined in section 2 of P.L.2003, c.280 (C.45:14-41), as a means to:

(1) prevent the possible development of physical or psychological dependence in the patient;
(2) document the understanding of both the practitioner and the patient regarding the patient’s pain management plan;
(3) 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 of Schedule II controlled dangerous substances, including any restrictions on the refill of prescriptions or the acceptance of Schedule II prescriptions from practitioners;
(4) identify the specific medications and other modes of treatment, including physical therapy or exercise, relaxation, or psychological counseling, that are included as a part of the pain management plan;
(5) 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
(6) 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.

[22]             See N.J.S.A. 24:21-15.2(e); N.J.A.C. 13:35-7.6(e).
[23]             See N.J.S.A. 24:21-15.2(b).
[24]             See id.
[25]             See N.J.A.C. 13:35-7.6(f)(1).
[26]             See N.J.A.C. 13:35-7.6(f)(3-4).
[27]             See N.J.A.C. 13:35-7.6(f)(6).
[28]             See N.J.A.C. 13:35-7.6(f)(8).
[29]             See N.J.A.C. 13:35-7.6(f)(9).
[30]             See N.J.A.C. 13:35-7.6(f)(10).
[31]             See N.J.A.C. 13:35-7.6(f)(11).
[32]             See N.J.S.A. 24:21-15.2(h); N.J.A.C. 13:35-7.6(j).
[33]             “Telemedicine” means the delivery of a health care service using electronic communications, information technology, or other electronic or technological means to bridge the gap between a health care provider who is located at a distant site and a patient who is located at an originating site, either with or without the assistance of an intervening health care provider, and in accordance with the provisions of [N.J.S.A. 45:1-61 to -66]. See N.J.S.A. 45:1-61. “Telemedicine” does not include the use, in isolation, of audio-only telephone conversation, electronic mail, instant messaging, phone text, or facsimile transmission. See id.
[34]             “Telehealth” means the use of information and communications technologies, including telephones, remote patient monitoring devices, or other electronic means, to support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services in accordance with the provisions of N.J.S.A. 45:1-61 to -66.  See N.J.S.A. 45:1-61.[35]             New Jersey regulations state that a practitioner shall not dispense drugs or issue prescriptions to an individual without first having conducted an examination, which shall be appropriately documented in the patient record.  See N.J.A.C 13:35-7.1A.  As part of the patient examination, the practitioner must: (a) perform an appropriate history and physical examination; (b) make a diagnosis based upon the examination and all diagnostic and laboratory tests consistent with good medical care; (c) formulate a therapeutic plan and discuss such plan, along with the basis for the plan and the risks and benefits of various treatment options, with the patient; and (d) ensure the availability of the physician or coverage for the patient for appropriate follow-up care.  See id.  However, an examination of the patient’s condition is not be required prior to the dispensing of drugs or the issuance of a prescription under the following circumstances:  (a) in admission orders for a newly hospitalized patient; (b) for a patient of another physician for whom the practitioner is taking calls; (c) for continuation medications on a short term basis for a new patient prior to the patient’s first appointment; (d) for an established patient who, based on sound medical practice, the physician believes does not require a new examination before issuing a new prescription; (e) for a patient examined by a healthcare professional who is in collaborative practice with the practitioner; and (f) when treatment is provided by a practitioner for an emergency medical condition. See id.

[36]             See N.J.S.A. 45:1-62(e); N.J.A.C. 13:35-6B.6; see generally N.J.S.A. 45:1-61 to -66 (Telemedicine & Telehealth).
[37]             See N.J.S.A. 45:1-62(e); N.J.A.C. 13:35-6B.6.
[38]             See N.J.S.A. 24:21-15.2(j); N.J.A.C. 13:35-7.6(i).
[39]             See id.
[40]             See N.J.A.C. 13:35-7.6(j).
[41]             See id.
[42]             See Letter Anne Milgram, DEA Administrator, to Registrants.  Jan. 12, 2023.  (https://www.deadiversion.usdoj.gov/pubs/docs/A-23-0020-Dear-Registrant-Letter-Signed.pdf).
[43]             See id.

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