Analysis & Summary of Revised NH Board of Medicine Rules for Opioid Prescribing for Chronic Pain

The following is brief analysis, summary and tracked changes in a copy of the New Hampshire Board of Medicine (BOM) Med 502 rules relating to the prescribing of opioids for chronic pain resulting from HB 1639 and BOM revised rules #13248 approved by JLCAR, effective 8-6-21.

 

Analysis

Having assisted chronic pain patients in the development of the legislation and the BOM in drafting of the resulting rules, the intent of the revised opioid prescribing law and rules are to:

  1. prohibit the arbitrary prescription dose limits for chronic pain patients increasing imposed by retail pharmacies and pain management practices; and
  2. provide clearer guidance and flexibility for physicians and PAs in prescribing opioids for chronic pain patients where opioid treatment has increased functionality and quality of life.

No changes have occurred for opioid prescribing for Acute Pain (Med 502.04), Prescription Drug Monitoring Program (Med 502.06) or Medication Assisted Treatment (Med 502.07).

 

For questions or further information, contact Jim Potter at james.potter@nhms.org or call 603-224-1909.

Any clinical practices or policies that appear to be in violation of these revised opioid prescribing rules can be reported to the NH Board of Medicine at https://www.oplc.nh.gov/report-non-compliance.

 

Summary

In brief, the HB 1639 and BOM Rule #13248 changes:

  1. Med 502.03 definitions in (d) “chronic pain” including references to similar clinical terms and (h) updating the term “morphine milligram equivalent (MME)”; and
  2. Med 502.05 Chronic Pain under subsection (b):
    • (4) changing prescribing for chronic pain to “opioid analgesics in a measured and monitored manner and administered in the lowest amount necessary to control pain” that differs from acute pain prescribing “for the lowest effective dose for a limited duration.”
    • (8) adding “titration” discontinuation or tapering of opioids “based on ongoing, objective evaluation of the patient’s injury or illness as required for ongoing successful treatment of chronic pain;”
    • (10) removing any MME dose limit reference for opioid prescribing longer than 90 days; and
    • (15) allowed continued prescribing of opioid analgesic treatment for chronic pain which has resulted in an increase in functionality and quality of life for the patient, when there is no indication of misuse or diversion.

 

 

The following copy of the New Hampshire BOM Rules (Med 502) for opioid prescribing highlights

revised additions tracked in underlined green, and deletions tracked in strikethrough red

Med 100-600 rules can be found at http://gencourt.state.nh.us/rules/state_agencies/med100-600.html.

 

PART Med 502  OPIOID PRESCRIBING (Revised 8-6-21)

          Med 502.01  Applicability.  This part shall apply to the prescribing of opioids for the management or treatment of non-cancer and non-terminal pain, and shall not apply to the supervised administration of opioids in a health care setting.

Source.  #11090, eff 5-3-16; ss by #12038, eff 1-1-17

 

          Med 502.02  Noncompliance with Standards as Unprofessional Conduct.  Noncompliance with the standards set forth in this part may constitute unprofessional conduct as used in NH RSA 329:17, VI(d).

Source.  #11090, eff 5-3-16; ss by #12038, eff 1-1-17

 

                  Med 502.03  Definitions. Except where the context makes another meaning manifest, the following words have the meanings indicated when used in this chapter:

         (a)  “Acute pain” means the normal, predicted physiological response to a noxious chemical, thermal, or mechanical stimulus and typically is associated with invasive procedures, trauma, and disease. It can be time-limited, often less than 3 months in duration;

         (b)  “Administer” means an act whereby a single dose of a drug is instilled into the body of, applied to the body of, or otherwise given to a person for immediate consumption or use;

         (c)  “Addiction” means a primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include impaired control over drug use, craving, compulsive use, or continued use despite harm. The term does not include physical dependence and tolerance, which are normal physiological consequences of extended opioid therapy for pain;

         (d)  “Chronic pain” means a state in which non-cancer pain persists beyond the usual course of an acute disease or healing of an injury, or that might or might not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years. It also includes intermittent episodic pain that might require periodic treatment.  For the purposes of these rules, chronic pain does not include pain from cancer or pain from terminal disease.  “Chronic pain” includes but is not limited to pain commonly referred to as "chronic," "intractable," "high impact," "chronic episodic," and "chronic relapsing."

         (e)  “Clinical coverage” means specified and prearranged coverage that is available 24 hours a day, 7 days a week, to assist in the management of patients with chronic pain;

         (f)  “Dose unit” means one pill, one capsule, one patch, or one liquid dose;

         (g)  “Medication-assisted treatment” means any treatment of opioid addiction that includes a medication, such as methadone, buprenorphine, or naltrexone, that is approved by the FDA for opioid detoxification or maintenance treatment;

         (h)  “Morphine milligram equivalent dose (MME)” means a conversion of various opioids to a morphine equivalent dose by the use of board approved conversion tables;

         (i)  “Prescription” means a verbal, or written, or facsimile, or electronically transmitted order for medications, for self-administration by an individual patient.

         (j)  “Risk assessment” means a process for predicting a patient’s likelihood of misusing or abusing opioids in order to develop and document a level of monitoring for that patient;

         (k)  “Treatment agreement” means a written agreement that outlines the joint responsibilities of licensee and patient; and

         (l)  “Treatment plan” means a written plan that reflects the particular benefits and risks of opioid use for each individual patient and establishes goals, expectations, methods, and time course for treatment.

Source.  #11090, eff 5-3-16; ss by #12038, eff 1-1-17 (from Med 502.02); ss by #13248, eff 8-6-21

 

          Med 502.04  Acute Pain.  If opioids are indicated and clinically appropriate for prescription for acute pain, prescribing licensees shall:

          (a)  Conduct and document a physical examination and history;

          (b)  Consider the patient’s risk for opioid misuse, abuse, or diversion and prescribe for the lowest effective dose for a limited duration;

          (c)  Document the prescription and rationale for all opioids according to Med 501.02(d) and (e);

          (d)  Ensure that the patient has been provided information that contains the following:

(1)  Risk of side effects, including addiction and overdose resulting in death;

(2)  Risks of keeping unused medication;

(3)  Options for safely securing and disposing of unused medication; and

(4)  Danger in operating motor vehicle or heavy machinery;

          (e)  Comply with all federal and state controlled substances laws, rules, and regulations;

          (f)  Complete a board-approved risk assessment tool, such as the evidence based screening tool Screener and Opioid Assessment for Patients with Pain (SOAPP);

          (g)  Document an appropriate pain treatment plan and consideration of non-pharmacological modalities and non-opioid therapy;

          (h)  Utilize a written informed consent that explains the following risks associated with opioids:

(1)  Addiction;

(2)  Overdose and death;

(3)  Physical dependence;

(4)  Physical side effects;

(5)  Hyperalgesia;

(6)  Tolerance; and

(7)  Crime victimization;

          (i)  In an emergency department, urgent care setting, or walk-in clinic:

(1)  Not prescribe more than the minimum amount of opioids medically necessary to treat the patient’s medical condition. In most cases, an opioid prescription of 3 or fewer days is sufficient, but a licensee shall not prescribe for more than 7 days; and

(2)  If prescribing an opioid for acute pain that exceeds a board-approved limit, document the medical condition and appropriate clinical rationale in the patient’s medical record.

          (j)  Prescribers shall not be obligated to prescribe opioids for more than 30 days, but if opioids are indicated and appropriate for persistent, unresolved acute pain that extends beyond a period of 30 days, the licensee shall conduct an in-office follow-up with the patient prior to issuing a new opioid prescription.

Source.  #11090, eff 5-3-16; ss by #12038, eff 1-1-17 (from Med 502.03)

 

    Med 502.05  Chronic Pain

         (a)  This section shall only apply to the treatment of “chronic pain” as defined in Med 502.03(d) and shall not apply to the treatment of pain from cancer or pain from terminal disease.

         (b)  If opioids are indicated and prescribed for chronic pain, prescribing licensees shall:

(1)  Conduct and document a history and physical examination;

(2)  Conduct and document a risk assessment, including, but not be limited to, the use of an evidence-based screening tool such as the Screener and Opioid Assessment for Patients with Pain (SOAPP);

(3)  Document the prescription and rationale for all opioids according to Med 501.02(d) and (e);

(4)  Prescribe opioid analgesics in a measured and monitored manner and administered in the lowest amount necessary to control pain for the lowest effective dose for a limited duration.

(5)  Comply with all federal and state controlled substances laws, rules, and regulations;

(6)  Utilize a written informed consent that explains the following risks associated with opioids:

a.  Addiction;

b.  Overdose and death;

c.  Physical dependence;

d.  Physical side effects;

e.  Hyperalgesia;

f.  Tolerance; and

g.  Crime victimization;

(7)  Create and discuss a treatment plan with the patient. This shall include, but not be limited to the goals of treatment, in terms of pain management, restoration of function, safety, time course for treatment, and consideration of non-pharmacological modalities and non-opioid therapy. Informed consent documents and treatment agreements may be part of one document for the sake of convenience;

(8)  Utilize a written treatment agreement that is included in the medical record, and specifies conduct that triggers the titration, discontinuationor tapering of opioids based on ongoing, objective evaluation of the patient’s injury or illness as required for ongoing successful treatment of chronic pain;

(9)  The treatment agreement shall also address, at a minimum, the following:

a.  The requirement of safe medication use and storage;

b.  The requirement of obtaining opioids from only one prescriber or practice;

c.  The consent to periodic and random drug testing; and

d.  The prescriber’s responsibility to be available or to have clinical coverage available;

(10)  Document the consideration of a consultation with an appropriate specialist in the following circumstances:

   a.  When the patient receives a 100 mg morphine equivalent does daily for longer than

      90 days;

a.  When a patient is at high risk for abuse or addiction; or

b.  When a patient has a co-morbid psychiatric disorder;

(11)  Reevaluate treatment plan and use of opioids at least twice a year;

(12)  Require random and periodic urine drug testing at least annually for all patients using opioids for longer than 90 days. Unanticipated findings shall be addressed in a manner that supports the health of the patient; 

(13)  Have clinical coverage available for 24 hours per day, 7 days per week, to assist in the management of patients;

(14)  The prescriber may forego the requirements for a written treatment agreement and for periodic drug testing for patients:

a.  Who are residents in a long-term, non-rehabilitative nursing home facility where medications are administered by licensed staff; or

b.  Who are being treated for episodic intermittent pain and receiving no more than 50 dose units of opioids in a 3 month period; and

(15)  Be allowed to continue prescribing opioid treatment, when there is no indication of misuse or diversion, for patients:

a.  Who experience chronic illness or injury which results in chronic pain; and

b.  Who are on a managed and monitored regimen of opioid analgesic treatment which has resulted in an increase in functionality and quality of life

Source.  #11090, eff 5-3-16; ss by #12038, eff 1-1-17 (from Med 502.04); ss by #13248, eff 8-6-21

 

          Med 502.06  Prescription Drug Monitoring Program.

          (a)  Prescribers required to register with the program under RSA 318-B:31-40, or their delegate, shall query the prescription drug monitoring program to obtain a history of schedule II-IV controlled substances dispensed to a patient, prior to prescribing an initial schedule II, III, and IV opioids for the management or treatment of this patient’s pain and then periodically and at least twice per year, except when:

(1)  Controlled medications are to be administered to patients in a health care setting;

(2)  The program is inaccessible or not functioning properly, due to an internal or external electronic issue; or

(3)  An emergency department is experiencing a higher than normal patient volume such that querying the program database would materially delay care.

          (b)  A licensee shall document the exceptions described in (a)(2) and (3) above in the patient’s medical record.

Source.  #11090, eff 5-3-16; ss by #12038, eff 1-1-17 (from Med 502.05)

 

          Med 502.07  Medication Assisted Treatment.

          (a)  Licensees who prescribe medication assisted treatment shall adhere to the principles outlined in the American Society of Addiction Medicine’s National Practice Guideline For the Use of Medications in the Treatment of Addiction Involving Opioid Use (2015) found at http://www.asam.org/quality-practice/guidelines-and-consensus-documents/npg/complete-guideline as cited in Appendix II.

Source.  #12038, eff 1-1-17 (from Med 502.06)