Kennebec Region Health Alliance

What is Chapter 21? Joint rule of the Board of Licensure in Medicine, the State Board of Nursing, and the Board of Osteopathic Licensure to ensure safe and adequate pain management for the citizens of Maine.

What is included in the 2018 update?

To read the rule in its entirety (RECOMMENDED):

http://www.maine.gov/md/laws-statutes/docs/Chapter%2021%20effective%2003.24.18.docx

This update now includes the changes to Maine State Law in regards to prescribing controlled substances (PL Chapter 488).

There are multiple changes to chapter 21 as compared to the previous 2010 version; the following is a summary of those elements most likely to affect daily practice:

1. Medical History and Physical: required for prescription of controlled substances for acute or chronic pain. Must be documented in the medical record. Shall include:
   1. Duration, location, nature and intensity of pain.
   2. The effect of pain on physical and psychological function, such as work, relationships, sleep, mood.
   3. Coexisting diseases or conditions.
   4. Allergies or intolerances.
   5. Current substance use.
   6.  Any available diagnostic, therapeutic or laboratory results.
   7. Current and past treatments of pain including consultation reports.
   8. Documentation of the presence of at least one recognized medical indication for the use of controlled substances if one is to be prescribed.
   9. All medications with date, dosage and quantity.
      
      
2. Risk Assessment: required for prescription of controlled substances for acute or chronic pain. No specific tool is endorsed by the Boards. Documentation must include a statement that the risks and benefits have been assessed.
   
   
3. Treatment Plan: must be recorded in the medical record. Needs to include objectives to determine treatment success, functional goals, other treatment modalities used or recommended.
   
   
4. Initiating treatment with Opiates: Rules advise lowest dose possible of a short-acting opiate for opiate-naïve patients. If prescribing for chronic pain, opiate therapy shall be presented as a therapeutic trial that shall last no longer than 30 days prior to re-assessment or dose escalation. Prescriber must be compliant with Maine Public Law c488.
   
   
5. Periodic Review of Efficacy: Review of patient’s function and response to treatment plan shall occur based on previous risk assessment at the following intervals:
   
   Level of Risk | Recommended Frequency
   Low risk and doses < 30 mg daily MME | Every 6-12 months
   Low risk | Every 6 months
   Moderate risk | Every 3 months
   High risk or Opioid doses > 90 mg/day daily MME | Every 1-3 months
   
   The following elements shall be included in the medical record as part of the periodic review:
   1. If pain, function, or quality of life have improved or diminished
   2. If continuation or modification of medications for pain management treatment is necessary based on the clinician's evaluation of progress towards treatment objectives.
   3. If there are any new or ongoing comorbidities (such as COPD, liver or renal failure, sleep apnea) or medications that may increase the risk for adverse effects such as overdose.
   4. Patient adherence to the treatment plan.
   5. Review the patient’sPrescription Monitoring Program profileif not done within the last 90 days.
   6. Calculate the patient’s daily MME if there has been a dosage change.
      
      
6. Informed Consent: Written, signed consent form required for prescribing opiates for chronic pain after 90 days. Forms shall include at a minimum the following:
   
   1. Benefits
      1. Reduction in pain.
      2. Improved physical and psychological functioning.
   2. Risks
      1. Side effects of the specific medication being used. These may include nausea, vomiting, constipation, drowsiness and impaired motor skills, cognitive impairment, falls, sexual dysfunction, and the potential for life-threatening respiratory depression.
      2. Ability to safely operate a vehicle in any mode of transportation.
      3. Allergic reactions.
      4. Interactions with other medications.
      5. The likelihood that tolerance to and physical and/or psychological dependence on the medication will develop with prolonged use.
      6. The risk of opioid misuse, addiction and potentially fatal overdose (especially when combining with alcohol and/or other psychoactive medication including but not limited to benzodiazepines and barbiturates), and the fact that this risk rises as the dose increases.
      7. In the case of physical dependence or addiction, patient awareness that sudden decreases or discontinuation of the medication may result in withdrawalsymptoms, which may include abdominal pain and cramping, vomiting, diarrhea, irritability, shakiness, insomnia, body aches and increased pain.
      8. The risk of potentially fatal overdose as a result of accidental exposure, especially by children.
      9. Women who are or may become pregnant should be counseled that opioid use during pregnancy is associated with adverse pregnancy outcomes such as preterm delivery, poor fetal growth, and stillbirth. Their child may also be born addicted to opioids and at risk for neonatal abstinence syndrome.
         
         
7. Treatment Agreements: Written, signed agreement required for prescribing opiates for chronic non-cancer/non-hospice/non-end-of-life pain after 90 days. Forms shall include at a minimum the following:
   
   
   1. The patient agrees to tell their clinician about all of their medical conditions and all medication they are taking.
   2. The responsibility of the patient to be discreet about possessing narcotics and keeping them in an inaccessible place so they may not be stolen.
   3. The patient agrees to take their medications only as prescribed, not to use any illegal substances or use alcohol in excess.
   4. The clinician’s prescribing policies and expectations, including:
      1. The patient will only obtain prescription opioids from one clinician or practice, except in the case of emergency for a new and severe pain.
      2. The use of a single designated pharmacy.
      3. The clinician’s policy on early refills, after hour refills, replacement of lost or stolen pills.
   5. The patient’s responsibility to inform the clinician if they do receive opioids from another clinician, and likewise to inform those clinicians that they have an opioid treatment agreement in place.
   6. An agreement that the patient will keep scheduled appointments and will comply with random pill counts and or random urine/blood testing to determine compliance.
   7. A statement that if the clinician becomes concerned that there has been illegal activity, the clinician may notify proper authorities, and it may specify that local episodic care facilities, other health care providers and pharmacies can be made aware of the treatment agreement.
   8. A statement that violation of the contract may result in opioids being reduced or discontinued, and that the patient may risk discharge from the practice.
      
      
8. Tox Screens/Pill Counts: A tox screen is required before initiating treatment for chronic pain, then periodically according to risk. A tox screen is required at least annually. Pill counts are suggested as another tool to monitor adherence but are not required.
   
   
9. CME: MDs must complete 3 hours of category I CME every 2 years regarding opiate prescribing whether or not they prescribe opiates. DOs and NPs follow current state law, which requires 3 hours of category I continuing education every 2 years as a condition of prescribing opiate medications.