Chapter 30 - Chronic Non-Cancer Pain Management

Part 3 - Professional Services

3-30.1  INTRODUCTION

1. Purpose.  The purpose of this chapter is to establish the Indian Health Service (IHS) policy related to the management of chronic non-cancer pain among patients treated in IHS facilities.
2. Scope.  The scope of this policy is pain management of patients 18 years and over with chronic non-cancer pain in the ambulatory care setting. The scope of this chapter does not cover pain management of cancer, perioperative pain, palliative care, end of life care, hospice care, pregnant women, or pain management for inpatient settings. Prescribers should refer to established clinical practice guidelines for recommendations surrounding chronic pain management in these conditions.
3. Background.  This policy was established to minimize the adverse psychological and physiological effects of unrelieved pain, promote appropriate opioid prescribing, and avoid pain medication misuse that contributes to the opioid overdose epidemic. This policy is based on the Guidelines for Prescribing Opioids for Chronic Pain (Centers for Disease Control and Prevention, 2022); the Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain (Federation of State Medical Boards, 2013), and HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics (US Department of Health and Human Services, 2019).
4. Authorities.
   1. The Snyder Act, 25 United States Code (U.S.C.) § 13Exit Disclaimer: You Are Leaving www.ihs.gov 
   2. The Transfer Act, 42 U.S.C. § 2001 et seq. Exit Disclaimer: You Are Leaving www.ihs.gov 
   3. The Controlled Substances Act, 21 U.S.C. § 801 et seq.Exit Disclaimer: You Are Leaving www.ihs.gov 
   4. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.Exit Disclaimer: You Are Leaving www.ihs.gov 
   5. The Indian Health Care Improvement Act, 25 U.S.C. § 1601 et seq.Exit Disclaimer: You Are Leaving www.ihs.gov 
   6. Related Policies:
   1. IHS Special General Memorandum 94-08, "Statement of Policy for the Traditional Cultural Advocacy Program"
   2. Indian Health Manual Part 3, Chapter 32, “State Prescription Drug Monitoring Programs”
   3. Indian Health Manual Part 3, Chapter 35, “Dispensing of Naloxone to First Responders”
   4. Indian Health Manual Part 3, Chapter 3, “Health Information Management”
5. Policy.  It is the policy of the IHS to:
   1. Respect and support the patient’s right to optimal pain assessment and management;
   2. Assess and manage patient’s pain;
   3. Provide appropriate pain management based on current knowledge of evidence-based and best clinical practices for the use of pharmacologic and non-pharmacological modalities and non-opioid therapies to treat pain;
   4. Refer patients to pain management specialists;
   5. Assess patient’s behavioral health. Refer patients to behavioral health services and, when needed, and where available, to traditional medicine practitioners, when requested by the patient as culturally appropriate to do so;
   6. Incorporate safeguards into clinical practices to minimize the risk of misuse and diversion of opioid analgesics and other controlled substances;
   7. Recognize the signs and symptoms of Opioid Use Disorder (OUD); opioid induced hyperalgesia; and consider opioid de-prescribing where clinically appropriate to do so;
   8. Establish multidisciplinary pain management teams for review of processes for treatment plans and patient management;
   9. Initiate opioid treatment as a shared decision between the health care provider and the patient; and
   10. Establish a culture for providers who do not fear disciplinary action for ordering, prescribing, dispensing, administering, or de-prescribing controlled substances, including opioid analgesics, for legitimate medical purposes and in the course of professional practice.

3-30.2  RESPONSIBILITIES

1. Chief Medical Officer, IHS.  The Chief Medical Officer, IHS is administratively responsible for the issuance of this policy.
2. Area Chief Medical Officer.  The Area Chief Medical Officer is administratively responsible for monitoring compliance with this policy among their respective Area Federal facilities.
3. Chief Executive Officer.  The health care facility Chief Executive Officer is responsible for approving/ensuring the hospital or clinic's chronic non-cancer pain management policy is fully reviewed and updated per Area Governing Board procedures.
4. Medical Director or Clinical Director.  The health care facility Medical Director or Clinical Director is responsible for:
   1. Ensuring the hospital or clinic is in compliance with this policy by establishing and implementing local protocols and procedures outlining the requirements set forth in this policy.
   2. Ensuring clinical privileging requirements and ongoing professional practice evaluation for opioid prescribing remain current for medical staff and in accordance with opioid stewardship best practices.
5. Pharmacy Director.  The health care facility Pharmacy Director is responsible for ensuring that all applicable Federal laws are followed regarding the procurement, storage, dispensing, and proper disposal of opioid medications.

3-30.3  DEFINITIONS

1. Chronic Opioid Treatment (COT).  Chronic opioid treatment refers to daily or near daily use of an opioid for greater than 60 days over the past 90-day period. Chronic Opioid Therapy is also known as long-term opioid therapy.
2. Controlled Substances.  . Controlled substances refer to drugs or chemicals which are controlled by state or Federal rules and regulations and must be dispensed pursuant to a valid medication order. Any drug that is a controlled substance in Schedules II, III, IV, or V of the Federal Controlled Substance Act must be dispensed in accordance with Section 503 (b)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 353] unless specifically exempted under 21 CFR § 290.2.
3. Dependence.  Dependence refers to the normal adaptive state that results in withdrawal symptoms if a medication is abruptly stopped or decreased.
4. Diversion of Controlled Substances.  Diversion of controlled substances refers to the redirection of legally obtained controlled substances from the individual prescribed the medication to another person, or to the acquisition of controlled substances by an illegal method.
5. Illicit Drugs.  Illicit drugs include illegal drugs (such as cannabis, non prescription opiates, and certain types of stimulants), pharmaceutical drugs (such as pain-killers and tranquilizers) when used for non-medical purposes, and other substances used inappropriately (such as inhalants).
6. Marijuana.  All parts of the plant Cannabis sativa, Cannabis indica, as well as various hybrids of the two strains, whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.
7. Milligram Morphine Equivalents.  Milligram Morphine Equivalents (MME), also referred to as Morphine Equivalent Dose, refers to a numerical standard to approximate an opioid medication’s potency compared to a morphine dose standard. Milligram Morphine Equivalents should not be used for direct dosing conversions between opioids, as the new opioid dose may be lower to avoid unintentional overdose caused by incomplete cross-tolerance and individual differences in opioid pharmacokinetics.
8. Naloxone.  Naloxone is an opioid antagonist that reverses the effects of opioids. Patients experiencing opioid overdose may suffer lethargy, somnolence, unconsciousness, respiratory failure or death if they do not receive prompt intervention with this reversal agent.
9. Pain.  Pain refers to an unpleasant sensory and emotional experience associated with actual or potential tissue damage. There are two types of common pain classifications:
   1. Acute Pain.  The normal, predicted physiological response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, and/or acute illness. Acute pain is generally time limited, is responsive to a variety of therapies including non-opioid and opioid treatment, and usually improves when the underlying cause has been treated or healed.
   2. Chronic Pain.  Chronic pain refers to a wide spectrum of diseases and conditions with causes that are multifactorial in nature. Chronic pain may include physical, psychological, social, and spiritual components while physical pain may be further classified as either somatic, visceral, or neuropathic. Chronic pain refers to a pain state which is persistent, typically three months or more, and exists beyond an expected time for healing. The cause of the pain may not be removable or otherwise treated. It may persist despite generally accepted medical treatment. This type of pain may be associated with end of life pathology involving cancer or organ failure
   3. Pain Management.  Pain management refers to the interdisciplinary approach to assist patients in making pain manageable, optimizing function, and maximizing quality of life. Optimal management of the patient experiencing chronic pain enhances healing and promotes both physical and psychological well-being. Strategies for chronic pain management may include therapies such as physical therapy, behavioral therapy, acupuncture, massage therapy, and some spiritual practices, as well as both non-opioid and opioid medications.
   4. Pain Management Team.  The Pain Management Team refers to those members of the clinical patient care team necessary to provide comprehensive, integrative, efficient, and effective care for patients with chronic pain. Teams may consist of representatives from medicine, nursing, pharmacy, physical therapy, rehabilitation professionals, behavioral health, social work, substance abuse disciplines, and Traditional Healing as available.
   5. Prescription Drug Monitoring Programs.  Prescription Drug Monitoring Programs (PDMPs) refers to an effective tool used to monitor treatment and deter prescription medication misuse, OUD, and diversion. All current PDMPs are state-based, electronic databases that collect data on controlled medications dispensed by registered pharmacies operating within the state. The PDMPs may vary in the controlled substance schedules reported, how data is entered, and access to information in the database. The policy surrounding practitioner PDMP utilization is defined in the Indian Health Manual (IHM), Part 3, Chapter 32, “State Prescription Drug Monitoring Programs.”
   6. Substance-Related and Addictive Disorders.  This broad classification added to DSM-V incorporates a broad spectrum of illicit and prescribed drugs in the opioid class. The diagnosis of OUD is defined in DSM-V.
   7. Tolerance.  Tolerance refers to a physiological state resulting from regular use of a medication in which an increased dosage is needed to produce a specific effect, or a reduced effect is observed with a constant dose over time.
   8. Opioid Dependence.  A state in which many physiological body functions depend on the presence of a certain level of an opioid.
   9. Traditional Medicine.  Traditional medicine refers to knowledge, skills, and practices, including the use of healing herbs and/or ceremonies and/or spiritual emphasis, based on the theories, beliefs, and experiences of American Indians and Alaska Natives in the prevention, diagnosis, improvement or treatment of physical and mental illness.

3-30.4  INFORMED CONSENT

1. Providers will ensure that all patients being started on chronic non-cancer pain management with an opioid medication will have a signed informed consent on file in the patient’s medical record.
2. Informed consent to initiate opioid treatment should discuss the risks and benefits of the treatment plan (including any proposed use of opioid analgesics) with the patient, persons designated by the patient, the patient’s surrogate or guardian. The policy surrounding consent is defined in the Indian Health Manual Part 3, Chapter 3, “Health Information Management.”
3. Written informed consent should address:
   1. Potential risks and anticipated benefits of chronic opioid treatment;
   2. Potential side effects and risks (both short- and long-term) of the medication, such as constipation and cognitive impairment, as well as overdose and death;
   3. The likelihood that tolerance to and physical dependence on the medication will develop;
   4. The risk of drug interactions and over-sedation, especially when combined with benzodiazepines or alcohol;
   5. The risk of impaired motor skills (affecting driving and other tasks);
   6. The risk of OUD, misuse, dependence, and overdose;
   7. The limited evidence as to the benefit of long-term opioid treatment; and
   8. Release of information to coordinate care with other treatment providers.

3-30.5  TREATMENT AGREEMENT

1. Providers will establish a treatment agreement with all patients prior to the initiation of chronic non-cancer pain management with an opioid medication. The treatment agreement must be signed and on file in the patient’s medical record.
2. Treatment agreements outline the joint responsibilities of the provider and patient. Treatment agreements shall be established for chronic opioid treatment or other medications that have a potential for misuse or diversion. Treatment agreements should be patient-centric and trauma-informed.
3. After treatment begins, the provider may adjust medication therapy to the individual medical needs of each patient.
4. Other treatment methods or rehabilitation programs may be necessary depending on the cause of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
5. The treatment agreement should include:
   1. The goals of treatment, in terms of pain management, restoration of function, and safety;
   2. The patient’s responsibility for safe medication use, including not using more medication than prescribed or using the opioid in combination with alcohol or other substances; storing medication in a secure location; and safe disposal of any unused medication;
   3. The patient’s responsibility to obtain his or her prescribed opioids from only one physician or practice. This includes the patient’s responsibility to inform the prescriber or practice of controlled substance prescriptions received from acute care settings;
   4. The patient’s agreement to periodic drug testing (such as blood, urine, hair, or saliva);
   5. The provider’s responsibility to be available or to have a covering provider available to address unforeseen concerns and to prescribe scheduled refills;
   6. The provider’s prescribing policies and expectations, including the number and frequency of prescription refills, as well as the provider’s practices on early refills and replacement of lost or stolen medication; and
   7. Specific reasons for which drug therapy may be changed or discontinued (including the violation of the policies, practices, and agreements spelled out in the treatment agreement).

3-30.6  COMBINED INFORMAED CONSENT AND TREATMENT AGREEMENTS

1. Informed consent and treatment agreements may be part of one document.
2. Examples of informed consent and treatment agreements are available on the IHS website.

3-30.7  ACUTE PAIN

Acute pain can often be managed without opioids. It is important to evaluate the patient for reversible causes of pain, for underlying causes that could lead to potentially serious aftereffects, and to determine appropriate treatment. When the diagnosis and severity of nontraumatic, nonsurgical acute pain are reasonably assumed to warrant the use of opioids, clinicians should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids, often three days or less, unless circumstances clearly warrant additional opioid therapy. More than seven days will rarely be needed.

3-30.8  SCREENING FOR PAIN

1. Patients should be screened for pain using appropriate scales selected based on developmental needs and/or cognitive ability as appropriate for their chief complaint.
2. Pain should be reassessed at appropriate intervals.

3-30.9  INITIAL ASSESSMENT

The patient experiencing chronic pain should be assessed for the below and findings documented within the patient treatment plan:

1. Comprehensive review of pain history (onset, location, quality, duration, and intensity), prior pain treatments, diagnostic tests, and functional status assessments;
2. Medical history and physical examination;
3. Past psychiatric history including depression, anxiety, and other emotional or personality disorders;
4. Current or prior substance use and abuse; including review of the patient's current psychosocial status, any history of mental health or substance abuse concerns, and assessment for relevant signs of misuse or abuse of substances;
5. Family and social history including employment, cultural background, and school or social network;
6. Legal history; and
7. Consider assessment for other behavioral patterns of concern, such as impulsive behaviors, through use of validated screening tools.

3-30.10  INITIATING CHRONIC OPIOD TREATMENT

1. The use of opioid treatment is indicated for moderate to severe pain that has failed to adequately respond to other therapeutic interventions. Its use is adjunctive and should rarely be the sole or initial therapeutic intervention for chronic pain.
2. Safer non-opioid/non-pharmacologic treatments should be utilized before initiating opioid treatment for chronic, non-malignant pain. Successful as well as failed non-opioid/non-pharmacologic treatments should be well documented in the medical record.
3. Opioid treatment should be presented to the patient as a therapeutic trial or test for a defined period of time (usually no more than 90 days) with specified evaluation points, with follow up within one to four weeks of initiation of opioid treatment or dose escalation.
4. Urine drug screening (UDS) should be performed and results interpreted prior to initiating chronic opioid therapy to establish a baseline measure for risk. Prescribers should understand the local lab test methodology and relevant cut-offs to fully interpret UDS results risk. Unexpected UDS results should be discussed with the patient and the treatment plan individualized. These results should not be used as the sole determination of patient adherence to the treatment plan.
5. Providers will review the patient’s history of controlled substances using state PDMP data to determine whether the patient is receiving opioid dosages or dangerous combinations that increase the risk for overdose.
6. The lowest dose possible should be initiated and titrated to bring about the desired effect.
7. When starting opioid treatment for chronic pain, clinicians should prescribe a short acting opioid and, if indicated, convert to a long acting/extended release formulation.
8. A decision to continue opioid treatment beyond the trial period should be documented in the medical record and reflect a careful evaluation of benefits versus adverse events and/or potential risks.
9. Providers are under no obligation to provide opioid treatment for chronic non cancer pain when the adverse events and/or potential risks outweigh the benefits.
10. Providers should avoid co-prescriptions of opioids with benzodiazepines, and other respiratory or central nervous system depressants whenever possible.

3-30.11  METHADONE

1. Methadone should not be the first choice for an extended release or long-acting opioid.
2. Clinicians considering prescribing methadone for pain should consider methadone’s unique risk profile. They should be prepared to educate and closely monitor their patients, including assessment for potential cardiac toxicity, QT prolongation, and electrocardiogram monitoring.

3-30.12  FENTANYL

1. Clinicians considering prescribing fentanyl for chronic pain should consider the absorption properties of transdermal fentanyl. They should be prepared to educate their patients about its use.
2. Clinicians should carefully follow Food and Drug Administration (FDA) black box warnings regarding transdermal fentanyl as well as be aware of the approved FDA Risk Evaluation and Mitigation Strategy.

3-30.13  MARIJUANA

1. Indian Health Service clinicians may not prescribe, dispense, or recommend marijuana as a form of medical treatment regardless of whether state law where they are or where the patient is located permits its use. These prohibitions include completing forms or registering patients for participation in a state approved or regulated marijuana program.
2. Clinicians and/or pharmacists may discuss marijuana use with the patient, when clinically relevant to patient care.
3. Clinicians and/or pharmacists may discuss with patients how their use of state approved medical marijuana to treat medical or psychiatric symptoms/conditions or state-legalized recreational marijuana may relate to the patient’s participation in other clinical activities (e.g., discuss how marijuana may impact other aspects of the overall care of the patient, such as how marijuana may interact with other medications the patient is taking, increase risk of sedation, or how the use of marijuana may impact overall pain management).
4. Clinical staff may discuss relevant clinical information regarding marijuana with the patient. When this is discussed, it must be documented in the patient’s medical record.
5. Providers need to make decisions to modify treatment plans based on marijuana use on a case-by-case basis. Such decisions need to be made in partnership with the patient and must be based on concerns regarding patient health and safety.

3-30.14  ONGOING MONITORING AND MANAGEMENT

1. The treatment plan should be reviewed at reasonable intervals based on the individual circumstances of the patient, but at a minimum of every three months.
2. The provider will review the patient’s progress and include any information about the cause of the pain or the patient’s overall health and level of function, such as his or her ability to engage in work or other activities of daily living; quality of family life and social activities; and participation in physical activities as evidenced by employability, participation in household chores, community volunteer roles, and any caregiver roles.
3. Urine drug testing should be conducted at least annually and as needed to ensure adherence to the patient treatment plan.
4. When possible and in compliance with all applicable Federal laws and regulations, providers may consider collecting collateral information about the patient’s response to opioid treatment from family members or other contacts.
5. State PDMP reports will be reviewed at regular intervals, in compliance with the IHM, Part 3, Chapter 32, “State Prescription Drug Monitoring Programs.”
6. At each visit addressing pain management, the results of chronic opioid treatment will be assessed utilizing the 6As of pain management to determine medication effectiveness and need for treatment modification. The 6As are as follows:
   1. Analgesic effects of medication,
   2. Adverse medication reactions,
   3. Aberrant behaviors,
   4. Activities of daily living function,
   5. Affect, and
   6. Adherence to treatment plan.

   Validated brief assessment tools that measure pain, function and risk of opioid misuse, should be used at initiation of chronic opioid use and throughout the course of treatment. Examples of screening tools can be found on the IHS Pain Management website.

7. Once the relative and absolute contraindications have been considered, all patients on 30 MME/day or more for over 60 days should be evaluated for conversion to a long acting opioid medication.
8. Clinicians will use caution and evaluate individual benefits and risks when increasing dosage to ≥ 50 MME/day, and should avoid increasing dosage to ≥ 90 MME/day or carefully justify a decision to titrate dosage to ≥ 90 MME/day.
9. Continuation or modification of therapy is dependent on the provider's evaluation of a patient's progress toward the stated treatment objectives and goals, such as improvement in pain associated symptoms, improved physical and psychosocial function including ability to work, need for health care resources, participation in activities of daily living, and quality of social life. This should be balanced with potential negative medication side effects or demonstration of aberrant behaviors related to medication use. The treatment plan and goals should be established as early as possible in the treatment process and revisited regularly.

3-30.15  PAIN MANAGEMENT TEAM

1. Management of chronic pain is an interdisciplinary process. Teams usually consist of representatives from medicine, nursing, pharmacy, physical therapy, rehabilitation professionals, behavioral health, social work, and substance abuse disciplines, as available.
2. Every effort should be made to communicate and document information to all members of the health care team regarding the patient’s pain experience in the Electronic Health Record.
3. Teams should meet regularly to review the care of patients on opioid treatment for chronic pain.
4. Multidisciplinary components that should be considered core features in the treatment of all patients on chronic opioid treatment include but are not limited to:
   1. Behavioral and psychological therapies;
   2. Physical therapy;
   3. Occupational therapy;
   4. Complementary and alternative therapies;
   5. Traditional medicine;
   6. Culturally specific spiritual practices;
   7. Pharmacological therapies including non-opioid medications, such as anti inflammatory medications, non-opioid analgesics, and muscle relaxants; adjuvant pain medications such as neuropathic medications, antidepressants, topical drug therapies; and
   8. Surgical therapies, which may include invasive anesthetic procedures (spinal injections, epidural blocks, nerve blocks), interventional treatments, joint injections, or the use of nerve stimulators.

3-30.16  CONTINUUM OF CARE

1. Whenever possible, patients will receive chronic pain management from one consistent provider.
2. In cases where an appointment with the primary treating provider is not available, patients may be assessed and treated by alternate medical providers in the same facility. Under these circumstances, opioid treatment is based on the alternate provider’s medical evaluation and clinical judgment.
3. An alternate provider may prescribe some, all, or none of the opioid medications for up to 30 days or until an appointment with the primary pain management provider is available, whichever comes first.
4. In some instances, an alternate provider may be unfamiliar with a patient or uncomfortable with the current treatment regimen. At such times the provider may request more frequent visits or re-evaluations for continued pain management until an appointment with the primary treating provider is available.
5. Whenever possible, primary pain treatment providers will attempt to coordinate care with alternate providers for their foreseen absence.
6. Treatment of chronic pain in urgent care or emergency room settings is inappropriate in most circumstances and should be avoided.
7. Contract or locums clinicians should be discouraged from the initiation of chronic opioid treatment. Consultation with the facility Clinical Director or multi-disciplinary pain management team by contract or locums providers will occur prior to initiation of chronic opioid treatment.

3-30.17  CONSULTATION AND REFERRAL

1. Providers should seek consultation with, or refer patients, as necessary, to a pain, psychiatry, behavioral health, or addiction specialist when clinically indicated.
2. Specialized assessment and treatment may be required for patients with a history of substance use disorder or a co-occurring mental health disorder.
3. Integrative or restorative therapies may be beneficial in managing both acute and chronic pain and have demonstrated a positive impact when employed as part of a multidisciplinary treatment plan following comprehensive patient assessments. These therapies are often delivered by physical therapists or occupational therapists and can include modalities such as therapeutic exercise, massage therapy, traction, cold/heat therapy, ultrasound, or bracing.
4. Consultation or referral may benefit the following types of patients:
   1. Patients with complex pain conditions with or without a clear source for their ongoing reports of pain;
   2. Pregnant or potentially pregnant patients;
   3. Patients with complex medical co-morbidities impacting their pain management;
   4. Patients with history of alcohol or substance use disorders;
   5. Patients requiring excess of 90 MME dose daily;
   6. Patients requiring continued escalation of dosing for adequate pain relief; and
   7. Patients scheduled for surgical interventions.

3-30.18  CO-PRESCRIBED NALOXONE

1. Consider naloxone prescribing for all patients on chronic opioid prescriptions and highly recommend for patients that exceed 50 MME/day.
2. Clinicians will incorporate into the pain management plan strategies to mitigate risk, including considering offering naloxone and training to the patient or a family member when there are factors that increase risk for opioid overdose, such as:
   1. Patients with sleep-disordered breathing; and /or respiratory disorders;
   2. Patients using concurrent benzodiazepines;
   3. Pregnant women;
   4. Patients with renal or hepatic insufficiency;
   5. Patients aged 65 years or older;
   6. Patients with mental health conditions;
   7. Patients with substance use disorder; and
   8. Patients with prior history of opioid overdose.

3-30.19  URINE DRUG TESTING

1. Urine drug testing is an important tool to monitor adherence to the treatment plan, as well as detecting the use of non-prescribed drugs. Sites should identify the urine drug testing methodology appropriate for their care setting. Clinicians should understand testing specificity and sensitivity in the interpretation of results.
2. Urine drug tests are recommended at initiation of the treatment agreement and periodically every 6 to 12 months thereafter, as appropriate. Urine drug testing may be performed more frequently at the discretion of the provider.
3. The urine drug test may be collected at a provider visit or, pursuant to local facility policies, ordered by other health professionals (e.g., nurse or pharmacist) before medication dispensing.
4. Test results that suggest opioid misuse should be discussed with the patient in a positive, supportive fashion, to strengthen the provider-patient relationship and encourage healthy behaviors (as well as behavioral change where needed).
5. Test results and subsequent discussion with the patient should be documented in the medical record.
6. It is recommended to confirm significant or unexpected results through quantitative testing and/or consultation with the laboratory toxicologist or clinical pathologist.

3-30.20  PERIODIC PILL COUNTING

1. Periodic pill counting can be a useful strategy to confirm medication adherence and to minimize diversion.
2. Providers should consider this tool as part of the management of adherence to the treatment plan and should implement pill counting periodically during opioid treatment especially when misuse or diversion is of concern.

3-30.21  MISUSE OR DIVERSION

1. Evidence of misuse of prescribed opioids demands prompt intervention by the provider.
2. Behaviors that require such intervention include:
   1. Recurrent early requests for refills;
   2. Multiple reports of lost or stolen prescriptions;
   3. Obtaining controlled medications from multiple sources without the provider’s knowledge;
   4. Intoxication or impairment (observed or reported);
   5. Pressuring or threatening behaviors;
   6. Documented drug diversion or prescription forgery;
   7. Presence of illicit or un-prescribed drugs in drug tests;
   8. Unsanctioned dose escalations;
   9. Deteriorating function; and
   10. Failure to comply with the treatment plan.
3. Patients meeting the diagnostic criteria for an OUD during the course of chronic pain treatment should undergo additional evaluation and management to include robust care coordination for the new diagnosis.

3-30.22  DISCONTINUING OPIOID TREATMENT

1. Continuation, modification, or discontinuation of opioid treatment should be contingent on the evaluation of:
   1. Evidence of the patient’s progress toward treatment objectives;
   2. Absence of substantial risk or adverse events, such as overdose or diversion; and
   3. Satisfactory response to treatment indicated by a reduced level of pain, increased level of function, and/or improved quality of life.
2. Consider tapering to a reduced opioid dosage, or tapering and discontinuing opioid treatment when:
   1. Pain improves;
   2. The patient requests dosage reduction or discontinuation;
   3. Pain and function are not meaningfully improved;
   4. The patient is receiving higher opioid doses without evidence of benefit from the higher dose;
   5. The patient has current evidence of opioid misuse;
   6. The patient experiences side effects that diminish quality of life or impair function;
   7. The patient experiences an overdose or other serious event (e.g., hospitalization, injury), or has warning signs of impending event such as confusion, sedation, or slurred speech;
   8. The patient is receiving medications (e.g., benzodiazepines) or has medical conditions (e.g., lung disease, sleep apnea, liver disease, kidney disease, fall risk, advanced age) that increase risk of adverse outcomes; and
   9. The patient has been treated with opioids for a prolonged period (e.g., years) and current benefit-harm balance is unclear.
3. Opioids should not be tapered rapidly or discontinued suddenly due to risk of significant opioid withdrawal.
4. If opioid treatment is discontinued, the patient who has become physically dependent should be provided with a safely structured individualized tapering regimen in addition to care coordination and alternate treatment modalities as available.
5. Withdrawal can be managed by the provider or by referring the patient to a pain specialist.
6. The discontinuation of opioid treatment should not mark the end of treatment, but treatment should continue with other modalities, either through direct care or referral to other health care specialists.
7. If escalation of opioid dosages does not lead to appreciable improvement in pain or the patient's overall daily function, the provider may reduce the opioid dosage or discontinue it entirely.
8. Advise patients that there is an increased risk for overdose on abrupt return to a previously prescribed higher dose.

3-30.23  CONSIDERATION FOR RESTARTING CHRONIC OPIOID TREATMENT

1. Restarting chronic opioid treatment for patients with a prior pain treatment plan violation, or after treatment has been discontinued by a provider for medical reasons, will be considered after consultation with the pain management team or in consultation with a pain specialist to determine if the violation issues or medical concerns have been addressed.
2. Providers are under no obligation to restart opioid treatment for patients with prior violations of pain treatment agreements or illegal activity related to controlled substances.

3-30.24  DOCUMENTATION

1. If a controlled substance is used, the medical record will clearly document the presence of one or more recognized medical indications for its use.
2. Upon initiating chronic opioid treatment, and as appropriate during the course of treatment, a complete medical history and physical examination must be conducted and documented in the medical record as it relates to the pain complaint; and will include:
   1. Diagnostic, therapeutic, and laboratory results;
   2. Treatment goals/objectives;
   3. Discussion of risks, benefits, and other treatment options;
   4. Treatments and medical indication for use of opioid medications;
   5. Medications including the date, drug name, drug form, dosage, and quantity prescribed;
   6. Informed consent and treatment agreements;
   7. Detailed justification of a decision to increase dosage to ≥ 90 MME/day;
   8. Results of ongoing monitoring patient progress (or lack of progress) in terms of pain management and functional status;
   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; and
   11. Authorization of release of information to other treatment providers.
3. Template forms in the Electronic Health Record are tools for documenting pain assessment and reassessment. These tools are available on the IHS Opioid Technical Assistance page.

3-30.25  PATIENT EDUCATION

1. Patient education should include, but is not limited to:
   1. Open and honest discussions about whether to start or continue opioid treatment;
   2. Explicit and realistic discussions of expected benefits of opioids;
   3. Emphasis that improvement in function is the primary goal and that function can improve even when pain is still present;
   4. Common side effects of opioids, including constipation, dry mouth, nausea, drowsiness, confusion, tolerance, physical dependence, and withdrawal symptoms when stopping opioids;
   5. Potential impairment while driving, performing physically hazardous tasks, operating dangerous equipment or machinery, and the dangers of concurrent use of alcohol and/or illicit drugs during opioid treatment;
   6. Appropriate storage and disposal of medications to minimize the risk for misuse, abuse, diversion, or accidental ingestion;
   7. Increased risks for OUD, respiratory depression, and death at higher dosages, along with the importance of taking only the amount of opioids prescribed; and
   8. Risks of respiratory depression when opioids are taken with benzodiazepines, other sedatives, alcohol, illicit drugs such as heroin, or other opioids, including providing the commonly known names of opioids
2. Patients will be provided a follow-up plan and specialty consultation instructions, if appropriate.

3-30.26  PATIENT GRIEVANCES

Local policies and procedures surrounding patient grievances will be utilized to address patient complaints surrounding implementation of this policy.

3-30.27  MEDICATION REFILLS AND PROXY MEDICATION DISPENSING

1. Local policies and procedures must outline the management of medication refills for lost or stolen prescriptions, early or missed refills, and proxy medication dispensing.
2. Emergency departments and urgent care settings are not appropriate for managing chronic pain and should rarely prescribe or dispense opioid medications for chronic pain management.

3-30.28  QUALITY MONITORING

1. Compliance with these policies and guidelines will be monitored regularly as part of opioid stewardship best practices with activities that may include:
   1. Formal peer review activities;
   2. Professional practice evaluations;
   3. Quality assurance reviews; and
   4. Governing body oversight to ensure appropriate treatment, monitor misuse and diversion, and adherence to Federal regulations.
2. Allegations of inappropriate pain management by a provider will be investigated and addressed at the local level in accordance with the established Medical Staff Bylaws.
3. Mortality and morbidity reviews conducted as part of ongoing medical quality assurance should also include procedures for the review and investigation of deaths related to internally prescribed and managed opioids.

3-30.29  NEW PROVIDER ORIENTATION

1. All new provider staff will complete an orientation on associated local policies and guidelines.
2. A copy of IHM, Part 3, Chapter 30, “Chronic Non-Cancer Pain Management,” will be provided to all new clinical staff before or at the orientation.

3-30.30  MANDATORY TRAINING

1. All Federal prescribers, contractors (that spend 50 percent or more of their clinical time under contract with the Federal Government), clinical residents and trainees are required to successfully complete the IHS Essential Training on Pain and Addictions within six months from the start of IHS employment.
2. Completion of the IHS-approved refresher training is required every three years.

3-30.31  PRIVILEGING

Copies of certificates of completion for the IHS Essential training will be maintained in the local credentialing and privileging file.

3-30.32  STATE PRESCRIPTION DRUG MONITORING PROGRAMS

Prescribers, pharmacists, and facilities should be in compliance with the IHM, Part 3, Chapter 32, "State Prescription Drug Monitoring Programs".