Board of Medicine Regulations

Effective March 15, 2017

Pursuant to the declaration of a public health state of emergency last fall and legislation passed during the General Assembly, several new laws and regulations have been established regulating the prescription of opioids for pain management and buprenorphine for substance abuse. The Board of Medicine announced on Tuesday, March 14 that it has adopted regulations which went into effect March 15 upon the Governor’s approval. See below for key components of the regulations for pharmacists to review closely.
Among the major provisions:

  • Limits on treatment of acute pain to 3 months
  • PMP check for opioids prescribed for more than seven days, fourteen days for pain related to surgery or invasive procedures
  • New regulations with specific documentation requirements for treatment of acute pain
  • Specific requirements for chronic pain management treatment plans and monitoring for abuse/addiction

Please familiarize yourself and your staff with these new rules. The regulations can be accessed at the Board of Medicine website.

Other Helpful Resources:

Key Considerations for Pharmacists

Pharmacists are advised to review the full regulation however, below are excerpts from the regulation that directly affect dispensing:

Acute Pain (less than 3 months):

Follow these guidelines when choosing the strength, length, and pill supply:

  •  Limits to the number of days in a supply:
    •  Acute: 7 days*
    •  Emergency department discharge: 7 days*
    •  Post-surgical: 14 days*
  • Limits to the number of pills in a supply:
    •  Follow manufacturer’s directions for use*
  • Limits to the prescribed strength:
    • > 50 MME, document reasons in the medical record
    • > 120 MME, document reasonable justification or refer to or consult with a pain management specialist

*May prescribe longer and/or exceed the manufacturer’s directions for use if extenuating circumstances are clearly documented in the medical record.

Clinical Dos and Don’ts Considerations

Do co-prescribe naloxone when the following risk factors exist:  Prior overdose, Substance abuse, Doses in excess of 120 MME/day, Concomitant benzodiazepine is present

Don’t co-prescribe an opioid if these medications are currently prescribed:* Benzodiazepines, Sedative hypnotics, Carisoprodol, Tramadol *If there is an extenuating circumstance, a prescriber may co-prescribe an opioid.  In this case, the prescriber is required to document a tapering plan to achieve the lowest possible effective dose.

Buprenorphine is not indicated for acute pain in outpatient setting, except when a waivered buprenorphine prescriber is treating pain in a patient whose primary diagnosis is the disease of addiction. (**and then, the approved delivery system is the Butrans patch – manufacturer labels have oral à topical conversion methods printed)

Chronic Pain (lasting greater than 3 months)

When choosing the strength of an opioid prescription, follow these guidelines:

  •  Limits to the prescribed strength:
    • > 50 MME/day, document reasons in the medical record
    • > 120 MME/day, document reasonable justification in the medical record and refer to or consult with a pain management specialist
Buprenorphine Prescribing

All prescribers must be waivered by the Substance Abuse Mental Health Services Administration (SAMHSA), registered with the Drug Enforcement Administration (DEA), and follow all state and federal laws governing buprenorphine prescribing.

  • Nurse Practitioners and Physician Assistants must be waivered and have a practice agreement with a waivered physician

During the induction phase, follow these guidelines:

  •  Initiate treatment with no more than 8 mg buprenorphine, except for medically indicated circumstances as documented in the medical record

During the stabilization phase, follow these guidelines:

  •  Increase the daily dosage of buprenorphine in safe and effective increments to achieve the lowest dose that avoids intoxication, withdrawal, or significant drug craving
    • Document in the medical record rationale for prescribed doses exceeding 16 mg of buprenorphine per day
    • Do not exceed 24 mg of buprenorphine per day
Clinical Dos and Don’ts Considerations

Don’t co-prescribe buprenorphine if the patient is already taking these medications*: Benzodiazepines, Sedative hypnotics, Carisoprodol, Tramadol *If there is an extenuating circumstance, a prescriber may co-prescribe buprenorphine.  In this case, the prescriber is required to document a tapering plan to achieve the lowest possible effective dose.

Prescribing Limits of Buprenorphine Mono-products (Subutex):

  •  Do not prescribe buprenorphine without naloxone (buprenorphine mono-product) unless:
    •  The patient is pregnant
    •  Converting a patient from methadone to buprenorphine containing naloxone for a period not to exceed 7 days
    •  Prescribing in formulations other than tablet form for indications approved by the FDA
Special Populations in Addiction Treatment:

Pregnant women

  •  Treat pregnant women with buprenorphine mono-product, usually 16 mg per day or less

Patients under 16 years

  •  Do not prescribe buprenorphine for addiction treatment unless such treatment is approved by the FDA