Code of Maine Rules
02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION
396 - BOARD OF LICENSURE OF PODIATRIC MEDICINE
Chapter 21 - USE OF CONTROLLED SUBSTANCES FOR TREATMENT OF PAIN
Section 396-21-4 - PRINCIPLES OF PROPER PAIN MANAGEMENT

Universal Citation: 02 ME Code Rules ยง 396-21-4

Current through 2024-13, March 27, 2024

1. Develop and Maintain Competence

Clinicians must achieve and maintain competence to assess and treat pain to improve function.This includes understanding current, evidence-based practices and using other resources and tools related to opioid prescribing. In some situations, consultation with a specialist is appropriate. Not all pain requires opioid treatment, and clinicians should not prescribe opioids when non-opioid medication is both effective and appropriate for the level of pain and function of the patient.

2. Universal Precautions

Because of the potential harmful effects of controlled substances, all clinicians prescribing them must employ Universal Precautionsunless unable to do so as a result of a genuine "medical emergency" as defined in Section 2 of this rule.Universal Precautionsis a standardized approach to the assessment and ongoing management of all patients whose pain is being treated with controlled substances. The Boards recognizethe fact that prescribing controlled substances carries with it the risk of physical and/or psychological dependency in patients, regardless of a pre-existing substance use disorderand that certain combinations of controlled substances and certain drug dosages further increase the risk of patient overdoses. The use of Universal Precautions is designed to mitigate the risk posed by prescribing controlled substances while simultaneously managing patient pain and any possible co-occurring medical issues. The elements of Universal Precautions are detailed below.

A. Evaluation of the Patient
(1) Medical History and Physical

Before prescribing any controlled substancesto a patient for acute or chronic pain, a clinician shall perform an initial medical history and appropriate physical examination and evaluation of the patient,which must be documented in the patient's medical record.The documentation shall include:

(a) Duration, location, nature and intensity of pain.

(b) The effect of pain on physical and psychological function, such as work,relationships, sleep, mood.

(c) Coexisting diseases or conditions.

(d) Allergies or intolerances.

(e) Current substance use.

(f) Any available diagnostic, therapeutic or laboratory results.

(g) Current and past treatments of pain including consultation reports.

(h) Documentation of the presence of at least one recognized medical indication for the use of controlled substances if one is to be prescribed.

(i) All medications with date,dosage and quantity.

(2) Risk Assessment

Before prescribing or increasing the dose ofany controlled substances to a patient for acute or chronicpain, a clinician shall perform and document a risk assessment of the patient.The risk assessment is meant to determine whether the potential benefits of prescribing controlled substances outweighs the risks, and includes factors involved in a patient's overall level of risk of developing adverse effects, abuse, addiction or overdose. For acute pain, a basic consideration of short term risk shall be assessed.

For the treatment of chronic pain, the use of an appropriate risk screening tool is encouraged. The following factors should be consideredas part of the risk assessment:

(a) Personal or family history of addiction or substance abuse/misuse.

(b) History of physical or sexual abuse.

(c) Current use of substances including tobacco.

(d) Psychiatric conditions; especially poorly controlled depression or anxiety. Use of a depressionscreening tool may be helpful.

(e) Regular use of benzodiazepines, alcohol, or other central nervous system medications.

(f) Receipt of opioids from more than one prescribing practitioner or practitioner group.

(g) Aberrant behavior regarding opioid use, such as repeated visits to an emergency department ("ED") seeking opioids.

(h) Evidence or risk of significant adverse events, including falls or fractures.

(i) History of sleep apnea or other respiratory risk factors.

(j) Comorbidities that may affect clearance and metabolism of the opioid medication.

(k) Possible pregnancy. Assess pregnant women taking opioids for opioid use disorder.If present, refer to a qualified specialist.

The clinician shall document in the patient's medical record a statement that the risks and benefits have been assessed.

B. Treatment with Controlled Substances
(1) Treatment Plan

The written treatment plan shall be documented in the patient's medical record. It shall state objectives, beyond subjective reports of pain, that will be used to determine treatment success, such as pain reduction and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. Specific functional goals shall be identified. Understanding that some pain cannot be fully relieved, realistic outcomes and expectations of treatment shall be discussed with the patient. Regular physical activity should be considered as part of the treatment plan unless contraindicated.

Opioids should be prescribed only if the clinician reasonably concludes that other treatment modalities including non-pharmacological treatments, and non-opioid alternatives up to a maximum recommended by the CDC or dictated by patient safety, have been inadequate to address the patient's pain and functionality. Other treatment modalities, referrals, or rehabilitation programs should be discussed with the patient and documented in the patient's medical record. This does not mean that all patients should expect to fail non-pharmacologic therapy before proceeding to opioids, but the benefits must outweigh the risks.

If a clinician is continuing treatment of chronic pain on a patient who was previously treated with long term controlled substances by another clinician, that patient requires re-assessment of the prior work up, non-pharmacologic treatment and appropriateness of the controlled substance dosing.

(2) Initiating or Continuing Prior Opioid Therapy

When prescribing controlled substances, clinicians shall:

(a) Prescribe the lowestpossible dosage to a controlled substance naïve patient and titrated to effect based on a documented functional assessment.

(b) Prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) when first initiating pain treatment. Long acting forms are more appropriate for chronic pain patientswhen immediate release forms are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

(c) When prescribing controlled substances for the treatment of chronic pain, cliniciansshall present it as a therapeutic trial for a defined period of time, and for no more than 30 days. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation.

(d) Dosage Limits
(i) The dosage of thecombination of opioid medication in an aggregate amount must not exceed 100 MME per day unless the patient meets one of theexemptionsto dosage limits identified below.

(ii) Any patients who have been prescribed more than 100 MME per day prior to January 1, 2017, their aggregate dosage cannot exceed 300 MME per day, and those patients who do not meet any exemptions to the dosage limits must be weaned below 100 MME per day by July 1, 2017.

(e) Prescription Requirements/Limits
(i) Electronic Prescriptions: EffectiveJuly 1,2017, prescriptions for controlled substances must be submitted electronically to the dispensing pharmacy unless the clinician's practice has obtained a waiver from the Commissioner of Health and Human Services.

(ii) Prescriptions for opioids that are prescribed for "palliative care" which will cause the patient to exceed the 100 MME aggregate daily limit must contain a diagnosis code (ICD-10) and an exemption code identified by any rule promulgated by the Maine Department of Health and Human Services.

(iii) Prescriptions for chronic pain shall be limited to a 30-day supply within a 30-day period. Although it is recommended that prescriptions for chronic pain be filled in multiples of 7 to reduce risk of weekend refill requests, with a maximum 28-day supply in a 28-day period.

(iv) Prescriptions for acute pain shall be limited to a 7-day supply within a 7-day period, unless the opioid product is labeled by the federal Food and Drug Administration to be dispensed only in a stock bottle that exceeds a 7-day supply as prescribed, in which case the amount dispensed may not exceed a 14-day supply.

(f) Exemptions to Dosage and Days' Supply Prescribing Limits
(i) Pain due to active cancer or cancer treatment oraftercare cancer treatment post-remission (Exemption Code A).

(ii) Palliative care in conjunction with a serious illness (Exemption Code B).

(iii) Hospice/end of life care (Exemption Code C).

(iv) Medically assisted treatment of substance use disorder (Exemption Code D).

(v) Medication is being directly ordered or administered in an emergency department setting, an inpatient hospital setting, a long-term care facility or a residential care facilityor in connection with a surgical procedure (in or out patient).

(vi) A pregnant individual with a pre-existing prescription for opioids in excess of the 100 MME aggregate daily limit. This exemption applies only during the duration of the pregnancy (Exemption Code E).

(vii) Acute pain for an individual with an existing opioid prescription for chronic pain. In such situations, the acute pain must be post-operative or new onset.The seven-day prescription limit applies (Exemption Code F).

(viii) Individuals pursuing an active taper of opioid medications, with a maximum taper period of six months, after which time the opioid limitations will apply, unless one of the other exceptions applies (Exemption Code G).

(ix) Individuals who are prescribed a second opioid after proving unable to tolerate a first opioid, thereby causing the individual to exceed the 100MME limit for active prescriptions. For this exemption to apply, each individual prescription must not exceed 100 MME (Exemption Code H).

(x) Any exception identified in any rule promulgated by the Maine Department of Health and Human Services.

(g) For high risk patients, consider equipping the patient, or others designated by the patient, with opioid antagonists (e.g. Naloxone) for the possible event of overdose.

(h) Avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

(3) Periodic Review of Treatment Efficacy

The clinician shall periodically review and document in the patient's medical record the course of pain treatment and any new information about the etiology of the pain or the patient's state of health and level of function. The frequency of review shall be determined by the patient's risk factors, the medication dose and other clinical indictors, and shall comply with the following:

Level of Risk

Recommended Frequency

Low risk and doses <30 mg daily MME

Every 6-12 months

Low risk

Every 6 months

Moderate risk

High risk or

Every 3 months

Opioid doses>90 mg/day daily MME

Every 1-3 months

During the periodic review, the clinician shall determine and/or perform the following actions, which shall be documented in the patient's medical record:

(a) If pain, function, or quality of life have improved or diminished using patient history and collateral information from family members or other caregivers.Collateral information of the patient's condition may include an ongoing assessment of the patient's functional status, such as the ability to engage in work or other gainful activities, the pain intensity and its interference with activities of daily living, quality of family life and social activities, and physical activity of the patient.Clinicians should also use measuring tools to assess the patient's level of pain, function and quality of life.

(b) If continuation or modification of medications for pain management treatment is necessary based on the clinician's evaluation of progress towards treatment objectives.

(c) 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.

(d) Patient adherence to the treatment plan.

(e) Review the patient'sPrescription Monitoring Program profileif not done within the last 90 days.

(f) Calculate the patient's daily MMEif there has been a dosage change.

If the patient's progress or compliance with the current treatment plan is unsatisfactory, the clinician shall consider tapering, changing or discontinuing treatment with controlled substances.

(4) Consultation or Referral

The clinician shall consult or refer, as necessary, for additional evaluation and treatment in order to achieve treatment objectives.Special attention should be given to those patients who:

(a) May benefit from psychoactive medications, such as benzodiazepines, because they may be at higher risk.

(b) Have a high risk for medication abuse, diversion, such as those on greater than daily 90 MME.

(c) Are at high risk for adverse effects from multiple co-morbidities or polypharmacy, especially the elderly.

Customary referrals may include: Physical, Occupational, Osteopathic or Chiropractic Therapy; Physiatry; Surgery; Chronic Pain Clinic; Geriatric consult; Psychiatric evaluation or counseling; and Methadone or Suboxone treatment for opioid addiction. Clinicians shall consider behavioral interventions to improve patient self-efficacy and address psychosocial barriers to recovery, such as Cognitive Behavioral Therapy, Mindfulness-Based Stress Reduction, yoga, acupuncture,etc.

(5) Patients with Opioid Use Disorder

Patients being treated for opioiduse disorderwith Suboxone, Methadone, Naloxone or any other medicationwho develop conditions causing acute pain may find it difficult to get the care they need because clinicians may feel wary of prescribing opioids to these patients. Yet they deserve a full evaluation and treatment of their pain. Prompt consultation with a pain or addiction specialist should be considered.

(6) Coordination of Care

Clinicians prescribing opioids to patients who have signed a narcotic contract with another clinician, shall contact that clinician to coordinate care if there are questions about treatment or concern for adverse effects of additional treatment or concerns of misuse.

(7) Discontinuing Opioid Therapy

If opioid therapy is discontinued, be it for treatment agreement violations, recurrent drug seeking behavior, lack of efficacy or adverse effects,the patient who has become physically dependent should be provided with a safely structured tapering regimen when appropriate. Withdrawal can be managed either by the prescribing clinician or by referring the patient to an addiction specialist. For patients with addiction/opioid use disorder, clinicians should offer or arrange for evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies). The termination of opioid therapy should not mark the end of treatment, which should continue with other modalities, either through direct care or referral to other health care specialists.

C. Informed Consent

Before prescribing any controlled substances to a patient for 90 days or more for chronic pain, the clinician shall discuss and obtain a written signed consent on the risks and benefits of the use of controlled substances with the patient, or, if the patient lacks the capacity to provide informed consent, from the patient's legal representative. The informed consent form shall at a minimum include the following benefits and risks:

(1) Benefits
(a) Reduction in pain.

(b) Improved physical and psychological functioning.

(2) Risks
(a) 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.

(b) Ability to safely operate a vehicle in any mode of transportation.

(c) Allergic reactions.

(d) Interactions with other medications.

(e) The likelihood that tolerance to and physical and/or psychological dependence on the medication will develop with prolonged use.

(f) 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.

(g) In the case of physical dependence or addiction, patient awareness that sudden decreases or discontinuation of the medicationmay result in withdrawalsymptoms, which may include abdominal pain and cramping, vomiting, diarrhea, irritability, shakiness, insomnia, body aches and increased pain.

(h) The risk of potentially fatal overdose as a result of accidental exposure, especially by children.

(i) 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.

D. Prescription Monitoring Program (PMP)
(1) Querying and Assessing Requirements on or after January 1, 2017.Prescribers must check the PMP:
(a) Before initiallyprescribing any benzodiazepine for any diagnosis.

(b) Before initially prescribing any controlled substance to a patient forthe treatment of acute or chronic pain, a clinician or his/her designee shall request patient prescribing information from the PMPthat covers at least the previous 12 months and document the PMP checkin the patient's medical record. The PMP must be queried at intervals not to exceed 90 days for as long as that prescription isrenewed.More frequent queries are encouraged for high risk patients, at thediscretion of the clinician.

(c) Under any of the circumstances described above, the clinician is responsible for reviewing and assessing the PMP information, which shall include:
(i) Checking the aggregate daily MME (to include any new prescription) for the person for whom medication may be prescribed;

(ii) Checking the number of clinicians currently prescribing controlled substances to the person for whom medication may be prescribed; and

(iii) Checking the number of pharmacies currently filling prescriptions for controlled substances to the person for whommedication may be prescribed.

(2) Exceptions

Clinicians are not required to query and assess patient prescribing information from the PMP when:

(a) The controlled substance is directly ordered for administration in an emergency department, inpatient hospital setting, a long-term care facility or a residential care facility; or

(b) The controlled substance is directly ordered, prescribed or administered to a person suffering from pain associated with end-of-life or hospice care.

E. Treatment Agreement
(1) Requirements

Before prescribing any controlled substances to a patient for 90 days or more for chronic non-cancer/non-hospice/non-end-of-lifepain, the prescriber and patient shall execute a written agreement for treatment that includes policies and expectations for the patient. The executed treatment agreement shall be documented in the patient's medical record and a copy given to the patient. Treatment agreements shall include the following:

(a) The patient agrees to tell their clinician about all of their medical conditions andall medication they are taking.

(b) The responsibility of the patient to be discreet about possessing narcotics and keeping them in an inaccessible place so they may not be stolen.

(c) The patient agrees to take their medications only as prescribed, not to use any illegal substances or use alcohol in excess.

(d) The clinician's prescribing policies and expectations, including:
(i) The patient will only obtain prescription opioids from one clinician or practice, except in the case of emergency for a new and severe pain.

(ii) The use of a single designated pharmacy.

(iii) The clinician's policy on early refills, after hour refills, replacement of lost or stolen pills.

(e) The patient's responsibility to inform the clinician if they do receive opioids from another clinician, and like wise to inform those clinicians that they have an opioid treatment agreement in place.

(f) 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.

(g) 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.

(h) 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.

(2) Violation of Treatment Agreements

If the agreement is violated, the violation and the clinician's response to the violation will be documented in the patient's medical record.In addition, the clinician shall document the rationale for changes in the treatment plan such as weaning the patient off medication, reporting to legal authorities etc.

F. Toxicological Drug Screens and Random Pill Counts
(1) Toxicological Drug Screens

Clinicians who prescribe controlled substances to a patient for 90 days or more for chronic non-cancer/non-hospice/non-end-of-life pain shall ensure that the patient undergoes atoxicological (e.g. urine or serum) drug screen prior to the initiation of treatment and then periodic random screeningduring the course of treatment to ensure that the patient is adhering to the prescribed treatment regimen. Clinicians may use clinical judgment in deciding whether or not to initiate a trial course of treatment prior to receipt of the results of the toxicological drug screen. These toxicological drug screens shall be done at least annually, but frequency should be based on the patient's level of risk.Clinicians shall be responsible for documenting in the patient's medical record the time, date and results of thetoxicologicaldrug screens.In addition, clinicians shall document the response to any abnormaltoxicologicaldrug screens, the discussion of the abnormal results with the patient, and the rationale for any changes to the treatment plan. Clinicians should be aware of the limitations of available testing and take care to order tests appropriately. Consultation with a laboratory toxicologist or clinical pathologist to confirm significant or unexpected results is advisable.

(2) Pill Counts

Random pill counts are an additional tool to ensure patient adherence to the prescribed treatment regimen. Clinicians should be confident that they are counting the actual medication that was prescribed and that it has not been replaced with a similarly appearing pill. Pharmacists may be helpful in pill identification or in preforming a random count. Results of pill counts should be documented in the patient's medical record.

G. Medical Records

The clinician shall keep accurate and complete medicalrecords on the above criteria, with emphasis on documentation of and the patient's response to controlled substances.Records should remain current and be maintained in an accessible manner, readily available for review. Information that should be maintained in the medical record includes:

(1) Copies of signed informed consent and treatment agreement.

(2) The patient's medical history.

(3) Documentation that a PMP query was performed.

(4) Results of the physical examination and laboratory tests.

(5) Results of the risk assessment, including results of any screening instruments or tools used.

(6) A description of the treatments provided, including all medications prescribed or administered (including the date, type, dose and quantity).

(7) Instructions to the patient, including discussions of risks and benefits.

(8) Results of ongoing monitoring of patient progress (or lack of progress) in terms of pain management and functional improvement.

(9) Notes on evaluations by and consultations with specialists.

(10) Any other information used to support the initiation, continuation, revision, or termination of treatment, and the steps taken in response to any aberrant medication use behaviors.

3. Reportable Acts

Generally, information gained as part of the clinician/patient relationship remains confidential. However, the clinician has an obligation to deal with persons who use the clinician to perpetrate illegal acts, such as illegal acquisition or selling of drugs; this may include reporting to law enforcement. Information suggesting inappropriate or drug-seeking behaviorshould be addressed appropriately and documented.Use of the PMP is mandatory in this situation.

4. Compliance With Controlled Substances Laws and Regulations

A. State and Federal Laws and Regulations

To prescribe, dispense or administer controlled substances, aclinician must possess an active license to practice in the State of Maine, a currentUnited States Department of Justice, Drug Enforcement Administration ("DEA") registration,and comply with applicable federal and state regulations. Clinicians are referred to the Practitioners Manual of the U.S. DOJ Drug Enforcement Administration and any relevant documents issued by theappropriateboard or agencyfor specific rules governing controlled substances as well asother applicable state regulations.

B. Methadone and Buprenorphine

Clinicians shall not prescribe methadone for treatment of opioid use disorderor for the treatment of chronic pain unless knowledgeable of methadone's non-linear pharmacokinetics, unpredictable clearance, multiple drug-to-drug interactions, and additional monitoring requirements. Office based prescribing of Suboxone for treatment of opioiduse disorder is restricted to clinicians who have training in addiction and are registered with the DEA as a Narcotic Treatment Program (NTP). In order to prescribe buprenorphine for opioid use disorder/addiction, clinicians must apply for a DATA 2000 waiver and be granted an "X" number by the DEA.

5. Use of the CDC Guideline for Prescribing Opioids for Chronic Pain

Clinicians are responsible for being familiar with the "CDC Guideline for Prescribing Opioids for Chronic Pain - United States 2016" (as published in the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, Early Release/Vol. 65, March 15, 2016.) when prescribing controlled substances for the treatment of chronic pain. Copies of the CDC guideline may be obtained at:

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

Disclaimer: These regulations may not be the most recent version. Maine may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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