by
Jason D. Gregoire
New Hampshire, like many states, is facing an opioid addiction crisis. In 2015, there were over 400 deaths in New Hampshire caused by powerful opioids like Heroin and Fentanyl. Federal, state, and local governments have struggled to find workable solutions to this extremely complicated problem that can be implemented quickly and effectively. Increased appropriations, prescription monitoring programs, construction of drug treatment facilities, and stepped up law enforcement are all steps that have been taken in an attempt to stem the rising death toll. This article discusses a recent measure taken to regulate the flow of prescription opioids to the public: The NH Board of Medicine’s Opioid Prescription Rules.
I. The History of the NH Opioid Prescription Rules
In the fall of 2015, Governor Hassan proposed a set of comprehensive emergency rules to restrict opioid prescriptions. After significant opposition from the NH Medical Society and other key stakeholders on the basis that the rules were too restrictive and did not give practitioners enough latitude to treat pain with opioids, the NH Board of Medicine rejected Governor Hassan’s proposed rules and adopted a limited set of temporary emergency opioid prescription rules in November 2015.
The Board of Medicine then vetted the emergency rules through the standard rulemaking process over the next six months. After considering comments and feedback from a myriad of stakeholders on both sides of the issue, the NH Board of Medicine passed permanent opioid prescription rules on April 5, 2016 to become effective on May 4, 2016. The final rules are now in effect and physicians must adhere to them in order to avoid discipline from the NH Board of Medicine and other collateral effects of discipline such as reporting to the National Practitioner Data Bank, receiving reciprocal discipline from other states of licensure, and revocation of DEA controlled substances registration.
II. The NH Opioid Prescription Rules
The rules, codified in the Med 502 series of the NH Administrative Regulations, are divided into rules governing treatment of acute pain and rules governing treatment of chronic pain. Notably, the rules do not apply to physicians treating cancer or palliative care patients.
A. Acute Pain Rules
The rules define “acute pain” as “the normal, predictable physiological response to noxious chemical, thermal or mechanical stimulus and typically is associated with invasive procedures, trauma and disease.” The Board generally considers pain of less than three months duration acute pain.
When treating a patient suffering from acute pain, a physician must:
- Conduct and document a physical examination and history.
- Consider the patient’s risk for opioid misuse, abuse, or diversion.
- Prescribe for the lowest effective dose for a limited duration.
- Document the prescription and rationale for prescribing.
- Provide the patient with information on all of the following topics:
- Risk of side effects including addiction and overdose resulting in death.
- Risks of keeping unused medication.
- Options for safely securing and disposing of unused medication.
- Danger in operating a motor vehicle or heavy machinery while under the influence of opioids.
- Comply with all federal and state controlled substances laws, rules, and regulations.
- 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).
With regard to the patient information requirement, the NH Board of Medicine has published a notice that, while not required, can be used to satisfy this requirement. The information sheet can be found at https://www.nh.gov/medicine/documents/acutepainpatientinfo.pdf
Physicians who provide episodic care to a patient who receives chronic care elsewhere must comply with the acute pain rules.
B. Chronic Pain Rules
The rules define “chronic pain” as “a state in which non-cancer pain persists beyond the usual course of an acute disease or healing of an injury, or that might not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years. It also includes episodic intermittent episodic pain that might require periodic treatment.” Chronic generally lasts longer than three months and does not include pain from cancer or terminal disease.
When treating a patient suffering from chronic pain, a physician must:
- Conduct and document a history and physical examination.
- Conduct and document a risk assessment, including, but not limited to the use of an evidence-based screening tool such as the Screener and Opioid Assessment for Patients with Pain (SOAPP).
- Document the prescription and rationale for all opioids.
- Prescribe the lowest effective dose for a limited duration.
- Comply with all federal and state controlled substances laws, rules, and regulations.
- Utilize a written informed consent that explains the following risks associated with opiates:
- Addiction
- Overdose and death
- Physical dependence
- Physical side effects
- Hyperalgesia
- Tolerance
- Crime victimization
- Create and discuss a treatment plan with the patient, which addresses issues such as goals of treatment in terms of pain management, restoration of function, safety, and time course for treatment.
- Utilize a written treatment agreement that is contained in the patient’s medical record and addresses, at a minimum, the following:
- Safe medication use and storage.
- Requirement to obtain opioids from only one prescriber or practice.
- Consent to periodic and random drug testing.
- Prescriber’s responsibility to have clinical coverage available.
- Conduct that will trigger the discontinuation or tapering of opioids.
- Document the consideration of a consultation with an appropriate specialist in the following circumstances:
- When the patient receives a 100 mg morphine equivalent dose daily for longer than 90 days.
- When a patient is at high risk for abuse or addiction.
- When a patient has a co-morbid psychiatric disorder.
- Require periodic review of the treatment plan and patient follow-up every four months.
- Require random and periodic urine drug testing at least annually for all patients using opioids for longer than 90 days.
- Have clinical coverage available 24 hours per day, 7 days per week.
- 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).
Please note that physicians treating chronic pain may forego written treatment agreements and periodic testing for those patients: (a) who are residents in a long-term, non-rehabilitative nursing home where medications are administered by licensed staff, or (b) who are being treated for episodic pain and will receive no more than 50 dose units of opioids in a three-month period.
The NH Medical Society has made various opioid prescribing tools and sample forms such as a pain evaluation, risk assessment, written consent form, and opioid treatment agreement available on its website at http://nhms.org/resources/opioid.
C. Prescription Drug Monitoring Program (PDMP)
In June 2012, the NH Legislature enacted RSA 318-B:31-38 into law making New Hampshire the 49th state to create a prescription drug monitoring program. This law required the NH Board of Pharmacy to contract with a third party for the implementation and operation of an electronic system to facilitate the confidential sharing of information relating to the prescribing of schedule II-IV controlled substances. The PDMP is intended to help prescribers avoid adverse drug interactions and identify drug-seeking behavior and “doctor shopping.”
The opioid prescribing rules require physicians prescribing or dispensing opioids to either acute or chronic care patients to query the PDMP database to obtain a history of schedule II-IV drugs dispensed to the patient: (a) prior to prescribing an initial schedule II-IV opioid for management or treatment of the patient’s pain; and (2) periodically and at least twice per year (for chronic patients). The two exceptions to the PDMP query requirement are:
- Controlled medications administered to patients in a “health care setting” (e.g., hospital, long-term care facility).
- Treating acute pain associated with serious traumatic injury, post-operatively, or with an acute medical condition for no more than 30 days.
III. Best Practices & Conclusion
All physicians who prescribe opioids to patients experiencing acute or chronic pain should promptly read the final rules and adopt policies, procedures, and appropriate forms to ensure immediate compliance with these rules. As discussed above, the NH Board of Medicine and the NH Medical Society have made a number of sample forms and agreements available on their websites in addition to hosting various CMEs on this topic. Physicians should also consult with legal counsel or the NH Board of Medicine if they do not understand any aspect of these rules.
Physicians who own medical practices should also take note that on December 18, 2015 the NH Board of Nursing adopted similar opioid prescribing rules applicable to APRNs. Moreover, the Center for Disease Control and Prevention recently adopted a Guideline for Prescribing Opioids for Chronic Pain to provide recommendations for the prescription of opioids to adults in the primary care setting experiencing chronic pain. Using these various tools, physicians can endeavor to continue safely prescribing opioids to their patients and hopefully stop the rising addiction and death rates from these powerful controlled substances.
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This article is intended to serve as a summary of the issues outlined herein. While it may include some general guidance, it is not intended as, nor is it a substitute for, legal advice.
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