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     Indian Health Manual

Part 3 - Professional Services

Chapter 30 - Chronic Non-Cancer Pain Management

Title Section
Introduction 3-30.1
    Purpose 3-30.1A
    Scope 3-30.1B
    Background 3-30.1C
    Authorities 3-30.1D
    Policy 3-30.1E
Responsibilities 3-30.2
    Chief Medical Officer, IHS 3-30.2A
    Area Chief Medical Officer 3-30.2B
    Chief Executive Officer 3-30.2C
    Medical Director or Clinical Director 3-30.2D
    Pharmacy Director 3-30.2E
Definitions 3-30.3
    Chronic Opioid Treatment (COT) 3-30.3A
    Controlled Substances 3-30.3B
    Dependence 3-30.3C
    Diversion of Controlled Substances 3-30.3D
    Milligram Morphine Equivalent 3-30.3E
    Naloxone 3-30.3F
    Pain 3-30.3G
Informed Consent 3-30.4
Treatment Agreement 3-30.5
Combined Informed Consent and Treatment Agreements 3-30.6
Acute Pain 3-30.7
Screening for Pain 3-30.8
Initial Assessment 3-30.9
Initiating Chronic Opioid Treatment 3-30.10
Methadone 3-30.11
Fentanyl 3-30.12
Ongoing Monitoring and Management 3-30.13
Pain Management Team 3-30.14
Continuum of Care 3-30.15
Consultation and Referral 3-30.16
Co-Prescribed Naloxone 3-30.17
Urine Drug Testing 3-30.18
Periodic Pill Counting 3-30.19
Misuse or Diversion 3-30.20
Discontinuing Opioid Treatment 3-30.21
Consideration for Restarting Chronic Opioid Treatment 3-30.22
Documentation 3-30.23
Patient Education 3-30.24
Patient Grievances 3-30.25
Medication Refills and Proxy Medication Dispensing 3-30.26
Quality Monitoring 3-30.27
New Provider Orientation 3-30.28
Mandatory Training 3-30.29
Privileging 3-30.30
State Prescription Drug Monitoring Programs 3-30.31

3-30.1  INTRODUCTION

  1. Purpose.  The purpose of this chapter is to establish the requirements for the development of local policies and procedures for the management of chronic non-cancer pain among patients seeking care in Indian Health Service (IHS) facilities.
  2. Scope.  The scope of this policy is pain management of patients 18 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.
  3. Background.  This policy was established to minimize the adverse psychological and physiological effects of unrelieved pain, promote appropriate opioid prescribing, and reverse the cycle of opioid 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, 2016); and the Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain (Federation of State Medical Boards, 2013).
  4. Authorities.
    1. The Snyder Act, 25 United States Code (U.S.C.) § 13
    2. The Transfer Act, 42 U.S.C. § 2001 et seq.
    3. The Controlled Substance Act, 21 U.S.C. § 801 et seq. Exit Disclaimer: You Are Leaving www.ihs.gov 
    4. Federal Food, Drug, and Cosmetic Act, 21 Chapter 9 Exit Disclaimer: You Are Leaving www.ihs.gov 
    5. IHS Special General Memorandum 94-08, "Statement of Policy for the Traditional Cultural Advocacy Program"
  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, when needed, and where available, to traditional medicine practitioners, when requested by the patient as culturally appropriate to do so.
    5. Incorporate safeguards into clinical practices to minimize the risk of misuse and diversion of opioid analgesics and other controlled substances.
    6. Establish multidisciplinary pain management teams for review of processes for treatment plans and patient management.
    7. Initiate opioid treatment as a shared decision between the health care provider and the patient.
    8. Establish a culture for providers who do not fear disciplinary action for ordering, prescribing, dispensing, or administering 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 IHS Chief Medical Officer is administratively responsible for the issuance of this policy.
  2. Area Chief Medical Officer.  The Area Chief Medical Officer is administratively responsible for monitoring this policy for compliance.
  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 privileging requirements for opioid prescribing remain current for medical staff.
  5. Pharmacy Director.  The health care facility Pharmacy Director is responsible for ensuring that all applicable Federal laws are followed regarding the 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 >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 under a under a prescription by an individual practitioner or a mid-level practitioner.  Any drug that is a controlled substance in Schedules II, III, IV, or V of the Federal Controlled Substance Act or implementing regulations must be dispensed in accordance with Section 503 (b)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 353(b)(1)] 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. 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.  MMEs should not be used for direct dosing conversions between opioids, the new opioid dose should be lower to avoid unintentional overdose cause by incomplete cross-tolerance and individual differences in opioid pharmacokinetics.
  6. Naloxone.  Naloxone is an opioid antagonist that reverses opioid toxicity.  Patients taking high doses of opioid medications can suffer lethargy, somnolence, unconsciousness, respiratory failure or death if they do not receive prompt intervention with this reversal agent.
  7. 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 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 3 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 occur 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, efficient, and effective care for patients with chronic pain.  Teams usually consist of representatives from medicine, nursing, pharmacy, physical therapy, behavioral health, social work, and substance abuse disciplines, as available.
    5. Prescription Drug Monitoring Programs.  Prescription Drug Monitoring Programs (PDMPs) refers to a primary tool used to monitor treatment and deter prescription medication misuse, opioid use disorder, 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 opioid use disorder is defined in DSM-V.
    7. Tolerance.  Tolerance refers to a physiologic 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 physiologic body functions depend on the presence of 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/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.
  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 if the patient is without medical decision-making capacity.
  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;
    5. The risk of impaired motor skills (affecting driving and other tasks);
    6. The risk of opioid use disorder, 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.
  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;
    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 care for unforeseen problems 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;
    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).
  6. The treatment plan should be reviewed at reasonable intervals based on the individual circumstances of the patient, but at a minimum of every 3 months.
  7. 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 healthcare resources, participation in activities of daily living, and quality of social life. The treatment plan and goals should be established as early as possible in the treatment process and revisited regularly.

3-30.6  COMBINED INFORMAED CONSENT AND TREATMENT AGREEMENTS

  1. Informed consent and treatment agreements may be part of one document.
  2. Examples of consent forms 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 etiologies with potentially serious sequelae, 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 3 days or less, unless circumstances clearly warrant additional opioid therapy.  More than 7 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

  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 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;
  3. Past psychiatric history including depression, anxiety, and other emotional or personality disorders;
  4. Current active substance use and abuse;
  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 and 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.
  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 a minimum of follow up within 4 weeks of initiation of opioid treatment or before each dose escalation.
  4. Urine drug screening should be performed prior to initiating chronic opioid therapy to establish a baseline measure for risk.
  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 put the patient at risk for overdose.
  6. The lowest dose possible should be given and titrate to bring about 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 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. Only clinicians who are familiar with methadone's unique risk profile and who are prepared to educate and closely monitor their patients, including assessment for potential cardiac toxicity, QT prolongation, and electrocardiogram monitoring, should consider prescribing methadone for pain.

3-30.12  FENTANYL

  1. Only clinicians who are familiar with the dosing and absorption properties of transdermal fentanyl and are prepared to educate their patients about its use should consider prescribing it.
  2. Clinicians should carefully follow Food and Drug Administration black box warnings regarding transdermal fentanyl.

3-30.13  ONGOING MONITORING AND MANAGEMENT

  1. The provider will review the patient's progress and include any information about the etiology 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.
  2. Urine drug testing should be conducted at regular intervals to ensure adherence to the patient treatment plan.
  3. 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.
  4. State PDMPs will be checked at regular intervals, in compliance with the IHM, Part 3, Chapter 32, "State Prescription Drug Monitoring Programs."
  5. At each visit, the results of chronic opioid treatment will be assessed utilizing the 6A's of pain management to determine medication effectiveness and need for treatment modification.  The 6A's 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.

  6. 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.  Clinicians will use caution and evaluate individual benefits and risks when increasing dosage to > 50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to > 90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.

3-30.14  PAIN MANAGEMENT TEAM

  1. Management of chronic pain is an interdisciplinary process and should include teams comprised of medical providers, nursing staff, behavioral health, pharmacy, and pain management specialists, as available.
  2. Every effort should be made to communicate information to all members of the health care team regarding the patient's pain experience.
  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.

3-30.15  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.  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 treating 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 will occur prior to initiation of chronic opioid treatment.

3-30.16  CONSULTATION AND REFERRAL

  1. Providers should seek consultation with, or refer patients, as necessary, to a pain, psychiatry, mental 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. 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.

3-30.17  CO-PRESCRIBED NALOXONE

  1. Consider naloxone prescribing with all patients on chronic opioids prescriptions and highly recommended 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;
    6. Patients with mental health conditions;
    7. Patients with substance use disorder; and
    8. Patients with prior history of opioid overdose.

3-30.18  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.
  2. Urine drug tests are recommended at initiation of the treatment agreement and periodically every 6-12 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.

3-30.19  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.

3-30.20  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.

3-30.21  DISCONTINUING OPIOID TREATMENT

  1. Continuation, modification, or termination 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. Reasons for discontinuing/terminating opioid treatment include:
    1. Occurrence of a severe outcome (e.g., overdose, another related medical event leading to hospitalization or disability);
    2. Patient request;
    3. Resolution of the underlying painful condition;
    4. Emergence of intolerable side effects;
    5. Inadequate analgesic effect;
    6. Failure to improve the patient's quality of life despite reasonable titration;
    7. Deteriorating function; and
    8. Significant aberrant medication use.
  3. If opioid treatment is discontinued, the patient who has become physically dependent should be provided with a safely structured tapering regimen.
  4. Withdrawal can be managed by the provider or by referring the patient to a pain specialist.
  5. 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.
  6. 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.

3-30.22  CONSIDERATION FOR RESTARTING CHRONIC OPIOID TREATMENT

  1. Restarting 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 acceptably 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.

3-30.23  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, 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, 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 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; 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 File Transfer Protocol site.

3-30.24  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, or diversion;
    7. Increased risks for opioid use disorder, 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.

3-30.25  PATIENT GRIEVANCES

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

3-30.26  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 should be addressed.
  2. Emergency departments and urgent care settings are not appropriate for managing chronic pain and should rarely prescribe or dispense opioid medications to cover long-term opioid treatment.

3-30.27  QUALITY MONITORING

  1. Compliance with these policies and guidelines will be monitored regularly through formal peer review activities; regular Medical Staff and Pharmacy quality improvement reviews; and 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 evaluated on an individual basis and will include available documentation of the treatment, use of a variety of sources to determine the appropriateness of treatment, including PDMPs, and will take into account whether the treatment is appropriate to the diagnosis and the patient's level of risk.
  3. Mortality and morbidity reviews should also include procedures for the review and investigation of deaths related to internally prescribed and managed opioids.

3-30.28  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.

3-30.29  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 refresher training is required every three (3) years.

3-30.30  PRIVILEGING

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

3-30.31  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".

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