Part 3 - Professional Services
Chapter 30 - Chronic Non-Cancer Pain Management
This section defines the responsibilities of Area Office and Service Unit staff involved in chronic pain management. Responsibility for the system-wide non-cancer pain management falls under the auspices of the medical staff of each facility.
- Purpose. This chapter establishes the policy and procedures for the management of patients with chronic non-cancer pain and updates the Indian Health Service (IHS) position on pain control and the related use of controlled substances.
- The Snyder Act, 25 United States Code (U.S.C.) § 13
- The Transfer Act, 42 U.S.C. § 2001 et seq.
- Relevant Laws.
- The Controlled Substance Act, 21 U.S.C. § 801 et seq.
- Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 301 et seq.
- Practitioner's Manual, United States (U.S.) Drug Enforcement Administration, 2006
- American Indian Religious Freedom Act of 1978, Public Law (P.L.) 95-341, 42 U.S.C. 1996 and 1996a http://www.blm.gov/ (IHS Special General Memorandum 94-8; Traditional Cultural Advocacy Program Policy Statement
- Background. Pain management, especially chronic non-cancer pain, has become an increasingly important clinical issue for health care providers as pain is the single most common reason for patients to seek medical care. In addition to the physical, physiologic, and psychosocial impact of pain on individual patients and their families, the burden on American society as a whole is tremendous.
The Institute of Medicine reports that the total annual incremental cost of health care due to pain ranges from $560 billion to $635 billion (in 2010 dollars) in the U.S., which combines the medical costs of pain care and the economic costs related to disability, lost wages, and productivity.
Unrelieved and inadequately controlled pain can have adverse physical and psychological effects. Pain, particularly when chronic in nature, is associated with deleterious changes on multiple quality-of-life measures, such as disturbed sleep, altered nutritional status, and reduced socialization. Pain can cause dysfunctional activities of daily living and impair cognition. Unrelieved pain increases the risk of falls and can retard rehabilitation.
Optimal management of the patient experiencing chronic pain enhances healing and promotes both physical and psychological well-being. The diagnosis and treatment of pain is integral to the practice of medicine. Appropriate pain assessment and treatment are of primary concern to patients, providers, and the American Indian/Alaska Native (AI/AN) community. The principles of a quality medical practice state that access to appropriate and effective pain relief is essential for patients. The appropriate application of current effective treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. Patients presenting with acute and chronic pain are encountered by healthcare providers in all patient care settings in the IHS and its affiliated programs. Patients' pain should be assessed and treated promptly with appropriate clinical modalities. With any modality used, the quantity and frequency of treatment should be adjusted according to the intensity and duration of the pain, as well as desired treatment outcomes.
Opioid prescriptions have increased dramatically, yet comprehensive programs using an array of approaches to pain management have not. These trends appear associated with increased opportunity for opioid drug diversion by individuals who seek them for other than legitimate medical use, and of particular concern, escalating numbers of overdoses and consequent deaths due to opioids.
- Policy. It is the policy of the IHS to ensure appropriate management of chronic non-cancer pain in order to improve patients' daily function and quality of life through prompt and effective assessment, diagnosis, and treatment of chronic non-cancer pain. Management includes strengthening the ability of patients and their families to communicate new or unrelieved pain; familiarizing staff, patients, and their families with the available pain management options that are safe, effective, and appropriate; and promoting active patient and pain management team participation in managing chronic pain.
- Addiction. Addiction refers to a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. (Approved by the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine, February 2001).
- Chronic Non-cancer Pain. Chronic non-cancer pain refers to a wide spectrum of diseases and conditions. Common diagnoses with secondary chronic non-cancer pain include but are not limited to: 'Failed back surgery syndrome', degenerative joint disorders, chronic abdominal or pelvic disorders, fibromyalgia, osteoarthritis, peripheral neuropathy, chronic back pain, rheumatoid arthritis, and chronic headaches. Note that chronic non-cancer pain should be clearly distinguished both diagnostically and therapeutically from acute pain and pain associated with malignancy.
- Chronic Opioid Therapy. Chronic opioid therapy (COT) refers to daily or near daily use of an opioid for at least 60 days.
- Chronic Pain Management Clinical Review Committee. Chronic Pain Management Clinical Review Committee refers to a local IHS care group charged with the design, oversight, and review of chronic non-cancer pain treatment processes, including the use of chronic opioid therapy. Membership includes IHS medical providers with experience in the management of chronic non-cancer pain, as well as IHS clinical representatives from pharmacy and behavioral health. The team may also include IHS representatives from nursing, substance abuse services, physical therapy, social work, and other types of federal health providers as required. Such teams may be composed entirely of clinic staff or may be part of a larger Service Unit or Area-based review group depending on the size of the clinic, availability of clinical staff with appropriate expertise, and other relevant factors.
- Complementary and Alternative Medicine. Complementary and alternative medicine (CAM) refers to a variety of treatment approaches and philosophies such as acupuncture, biofeedback, and chiropractic that differ substantially from contemporary allopathic approaches.
- 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 physician's prescription. 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.
- Dependence. Dependence refers to the normal adaptive state that results in withdrawal symptoms if a medication is abruptly stopped or decreased.
- Diversion of Controlled Substances. Diversion of controlled substances refers to legally obtainable drugs that are diverted from the individual prescribed the medication to another person, into illegal channels, or when controlled substances are obtained by an illegal method.
- 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:
- 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 therapy, and usually improves when the underlying cause has been treated or healed.
- Chronic Pain. Chronic pain refers to a pain state which is persistent, typically 2 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.
- 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.
- 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 non-cancer pain. The team shall consist of IHS practitioners that are legally authorized and locally privileged to prescribe controlled substances. The team shall also include IHS representatives from nursing, pharmacy, physical therapy, behavioral health, social work, and substance abuse disciplines as required, and available.
- Prescription Drug Monitoring Program. Prescription drug monitoring program (PDMP) refers to a primary tool used in implementing a National Drug Control Strategy. The PDMP may be used by prescribers and pharmacists to monitor treatment and deter prescription medication abuse, addiction, and diversion. All PDMPs to date are State-based, electronic databases that collect data on controlled medications dispensed by registered pharmacies operating within the State. All PDMPs may vary in the controlled substance schedules reported, how data is entered, and access to information in the database.
- Rescue Medication. Rescue medication refers to a strong short acting analgesic given to control acute episodes of breakthrough pain in patients on a continuous pain management regimen.
- 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. Tolerance may or may not be evident during opioid treatment and does not equate with addiction.
- Traditional Medicine. American Indian/Alaska Native traditional medicine refers to therapies used by many AI/AN Tribes that include their own healing herbs and ceremonies using components with a spiritual emphasis. All diseases have been treated with the use of AI/AN medicine, which does not preclude the use of additional medical therapies such as allopathic or CAM.
3-30.3 GENERAL PRINCIPLES
- Area Director. The Area Director is responsible for:
- Ensuring that administrative support and the necessary funds are made available at IHS hospitals in his or her Area to implement this policy.
- Ensuring that every IHS hospital in their Area has made available all other resources necessary to implement this policy.
- Area Chief Medical Officer. The Area Chief Medical Officer is responsible for working with the IHS Hospital Medical Director or Clinical Director to ensure that patient care and medical standards and concerns are represented in the decision-making process of the agency.
- Indian Health Service Hospital or Ambulatory Clinic Medical Director or Clinical Director. The health care facility Medical Director or Clinical Director is responsible for:
- Ensuring the hospital or clinic has implemented this chronic non-cancer pain management policy.
- Engaging in the peer review process for the purpose of improving documentation and discussion of chronic non-cancer pain management.
- Ensuring that credentialing and privileging remains current for medical staff.
- Indian Health Service Hospital or Ambulatory Clinic Chief Executive Officer. The health care facility Chief Executive Officer is responsible for:
- Ensuring the hospital or clinic establishes and implements local protocols and procedures outlining the requirements set forth in this policy.
- Ensuring the hospital or clinic has implemented this chronic non-cancer pain management policy.
- Approving the hospital or clinic's chronic non-cancer pain management policy and ensuring the policy is fully implemented, reviewed and updated annually, and submitted to the IHS Area CMO for monitoring purposes.
- Indian Health Service Hospital or Ambulatory Clinic 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 medication.
3-30.4 PATIENT RIGHTS AND RESPONSIBILITIES
- Pain Management. While the physician and other authorized prescribers maintain the authority and responsibility for prescribing controlled substances, pain management is the responsibility of the multidisciplinary pain management team. Pain management must be viewed as a part of quality medical practice for all patients with acute or chronic pain. Quality pain management is especially pertinent for patients who experience pain as a result of terminal illness. The medical management of pain must be grounded in current clinical knowledge, scientific research, and the use of pharmacologic and non-pharmacologic modalities.
- Pain Management Training. All providers must become knowledgeable about pain assessment and effective methods of pain treatment, as well as statutory requirements for prescribing controlled substances. All providers are expected to refer to current clinical practice guidelines and expert review in approaching cases or establishing programs involving management of pain.
- Pain Assessment. Patient's pain should be assessed and treated promptly with appropriate clinical modalities. The principles of a quality medical practice state that access to appropriate and effective pain relief is essential for patients. Patients presenting with acute and chronic pain are encountered by healthcare providers in all patient care settings in the IHS and its affiliated programs.
- Pain Treatment. The non-pharmacologic and pharmacologic treatment should be adjusted according to the intensity and duration of the pain and according to desired treatment outcomes.
- Inappropriate Treatment of Pain. The inappropriate treatment of pain includes non-treatment, under-treatment, over-treatment, and the use of ineffective treatments. Inappropriate pain treatment may result from the providers' lack of knowledge about pain management, incomplete or improper patient assessment, poor communication with the patient or other providers, conflicts arising from the provider-patient relationship, and other factors. Concerns about investigation or sanction may also result in inappropriate treatment of pain.
- Use Based on Sound Clinical Judgment. Physicians and other clinical staff should not fear disciplinary action from the IHS for ordering, prescribing, dispensing, or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the course of professional practice. The IHS considers prescribing, ordering, dispensing, or administering controlled substances for pain to be for a legitimate medical purpose if based on knowledge of effective treatment modalities and sound clinical judgment. To be within the usual course of professional practice, a provider-patient relationship must exist, and all prescriptions should be based on a pain assessment and diagnosis.
- Compliance. Compliance with Federal law as well as appropriate accreditation and credentialing bodies is required to order, prescribe, dispense, or administer controlled substances.
- Treatment Using Controlled Substances. Providers and facilities must incorporate safeguards into their practices to minimize the potential for the abuse and diversion of controlled substances. Providers should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not the same as addiction.
3-30.5 PROVIDER RESPONSIBILITIES REGARDING PAIN MANAGEMENT
- Patient Rights. The patient's right to pain management will be respected and supported as stated in the local facility's Patient Bill of Rights and Responsibilities.
- Respect and support includes acknowledging the patient's report that chronic pain exists. Staff will work with the patient to address their pain complaints.
- Patient rights are not to be interpreted as a right to be treated with any or certain therapies, including opioid medications or other controlled substances, if a provider determines such treatment as medically unsafe or unnecessary based upon medical evaluation.
- Patient Responsibilities. Patients, and where appropriate, their families and care givers are responsible for working closely with their pain management team to establish and implement an appropriate pain management plan, following the mutually agreed upon plan, communicating any concerns or disagreements about said plan to the pain management team, and working together to resolve them. The patient or the patient's surrogate or guardian, if the patient is a minor or is incompetent, and the pain management team are accountable for exercising appropriate caution to prevent misuse, abuse, or diversion of prescribed medications.
3-30.6 PAIN AND CHRONIC OPIOID THERAPY MANAGEMENT PROCEDURES
- Patient Assessment. Pain assessment is the responsibility of medical providers, nursing staff, and all other health care professionals providing direct care to the patient. At a minimum pain assessments shall be conducted as follows:
- All patients are initially screened for pain during triage and provider visits in whatever setting they present.
- All patients with pain identified through the screening process will receive further pain assessment and treatment as appropriate.
- All patients are screened before discharge for continuing pain.
- All patients treated for pain shall be reassessed at each visit to determine the presence of any side effects from their medications, any aberrant behaviors, the effectiveness of treatment, and whether new or altered approaches are needed.
- Pain Management Treatment. Pain management treatment is based on patient needs, medical assessment, care setting, knowledge of current effective treatment modalities, and the services available. Providers must participate in any local and/or national mandatory educational and training opportunities to improve their skills in pain management.
- Care of Patients. Local policies, procedures, and guidelines will be implemented and used to ensure the safe and effective use of pain treatment interventions. When needed services are not available locally, efforts will be made to identify, purchase and refer patients to such services.
- Education of Patients. Patients and families or the patient's representatives are provided educational information about pain management to ensure optimal understanding and the safe and effective use of interventions.
- Continuum of Care. Patients are provided a follow-up plan and specialty consultation instructions, if appropriate, at the time of discharge from the care setting.
3-30.7 TREATMENT GUIDELINES
- Local COT Management Procedures. Internal criteria and local policies must be established that outline the COT and pain management process in detail, including how the clinic will manage problematic medication discontinuation situations, expected documentation practice, and referral processes.
- Providers. Providers should discuss the risks, benefits, and alternatives of all medicines and treatments, including the use of controlled substances, with the patient, persons designated by the patient, or the patient's surrogate or guardian, if the patient is a minor or incompetent.
- Providers are under no obligation to provide COT when they deem it unsafe based on their clinical judgment.
- Providers are under no obligation to restart COT for patients with prior violations of pain policy or COT agreements or illegal activity related to controlled substances.
- Providers must maintain accurate and complete documentation in the patient's medical record in accordance with standards of care and legal authorities.
- Providers must perform periodic reviews of opioid use patterns, treatment plan implementation, overall effectiveness of pain management side effects, and medication security (Also see 3-30.10C).
- Prolonged use of opioids can result in opioid-induced hyperalgesia, a condition where the patient develops a hyper-sensitizing pain perception. If not recognized, this can lead a clinician to assume either the patient is under-treated with opioids or that the patient is exaggerating their pain for diversion purposes or addiction. Limiting the duration or dose of chronic opioid therapy can reduce the development of opioid-induced hyperalgesia.
Once recognized, the patient is best managed by cessation of chronic opioid therapy. Due to chronic opioid therapy potentially causing opioid-induced hyperalgesia resulting in increased pain perception (paradoxical effect), continuous opioid medication therapy should only be considered after non-opioid medications, psychotherapy, physical therapy, and other adjunctive treatments have been initiated and continued concomitantly without success. The COT should be last-line therapy and an adjunct to other treatment modalities in a comprehensive treatment strategy.
- Required Informed Consent and COT Agreement. Informed consent and the COT agreement must be signed at the time the use of COT can be reasonably clinically anticipated. In all circumstances, both the informed consent and the COT agreements should be signed within 60 days of the beginning of use. While informed consent and COT agreement negotiation may occur at the same time, providers must use separate forms with separate signature acknowledgment for each. Informed consent for COT addresses the risks, benefits, and alternatives for COT. All COT agreements should be periodically reviewed at least annually.
- Chronic Opioid Therapy Agreements. The purpose of an agreement is to outline boundaries, expectations, and responsibilities of patients and providers; and to assist with proper documentation. Chronic opioid therapy agreements outline the circumstances under which opioid pain medications may be initiated, used and discontinued in the treatment of chronic non-cancer pain; emphasize the expected participation in monitoring activities, such as periodic urine/serum medication levels screening and periodic medication counts; delineate consequences both for participation and non participation in the pain treatment plan; and establish basic rules and expectations regarding prescription accountability and renewals or refills.
- Participation is mandatory.
- Breach of the COT agreement by the patient may lead to discontinuation of therapy with controlled substances upon the discretion of the provider, the pain management team, or the Chronic Pain Management Clinical Review Committee. In such cases, alternative therapy will be offered, as appropriate.
- Examples of consent forms and COT agreements are available on the IHS website.
- Documentation.Template forms in the Electronic Health Record and Patient Care Component +(PCC+) are tools for documenting pain assessment and reassessment. These tools are available on the IHS Web site. If a controlled substance is used, the medical record will clearly document the presence of one or more recognized medical indications for its use. The use of a controlled substance flow sheet for tracking controlled substance prescriptions is recommended. 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:
- Medical history and physical examination.
- Diagnostic, therapeutic, and laboratory results.
- Evaluations and consultations.
- Treatment objectives.
- Discussion of risks, benefits, and alternatives.
- Treatments and medical indication for use of opioid medications.
- Medications including the date, drug name, drug form, dosage, and quantity prescribed.
- Instructions and treatment agreements.
- Patient Assessment and Reassessment. Patient Assessment and Reassessment will include:
- Screening Patients for Pain. Patients will be screened for pain by nursing personnel upon presenting for direct clinical services as part of the triage process. It is reasonable not to expect pain screening in patients presenting with conditions in which pain is not a symptom. For example, this might include presentation to the laboratory for specimen collection.
- Individualized Pain Assessment. Patients will be assessed for pain intensity and function based on reported activities of daily living correlated with appropriate physical examinations at the initial visit and any subsequent pain management follow-up visits to help determine effectiveness of medications and other therapies. An appropriate standardized pain scale should be used. Clear documentation of pain assessment and management includes patient and family feedback to gauge the adequacy of pain control.
- Acute Pain. Assessment for acute pain should include a measure of pain intensity. A pain assessment scale can be used as appropriate to the patient's age and mental capabilities. An assessment of the pain character, frequency, location, and duration should be included in all assessments.
- Chronic Pain. Due to regulatory restrictions on the prescription of controlled substances, it is recommended that the assessment of chronic pain include additional information regarding issues that may impact the safe use and effective management of opioid therapy. Patients identified as having chronic pain may have physical, psychological, social, and/or behavioral contributors to suffering that require special attention in an evaluation. Use of a screening instrument to determine risk for the future misuse or abuse of opioid medications is recommended. See the Chronic Pain section of the IHS website for examples.
- Comprehensive Assessment. A comprehensive assessment includes the following:
- 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.
- Past psychiatric history including depression, anxiety, and other emotional or personality disorders.
- Current active substance use and abuse.
- Family and social history including employment, cultural background, and school or social network.
- Marital history.
- Legal history.
- Other behavioral patterns of concern such as impulsive behaviors.
- Mental status examination.
- Reassessment. The effects of interventions for pain management are assessed and reassessed utilizing the 6A's of pain management to determine medication effectiveness and need for treatment modification. Activity diaries are optional tools for monitoring the effectiveness of pain management treatment. The 6A's of pain management are:
- Analgesic effects of medication.
- Adverse medication reactions.
- Aberrant behaviors.
- Activities of daily living function.
- Adherence to treatment plan.
- Monitoring. Some patients with chronic pain may unilaterally increase their opioid consumption without objective improvement in functional status. Subjective patient reports should be supported by objective observations. Objective measures in a patient's condition are determined by an ongoing assessment of the patient's functional status, such as his or her ability to engage in work or other gainful activities; consumption of health care resources; responses to specific questions about the pain intensity and its interference with 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. Additional assessment and monitoring of the patient's response to therapy can often be gained by interviewing the patient's family and significant others.
- Intensive Oversight. The following are additional procedures and guidelines for all patients requiring more than 30 milligram (mg) morphine equivalents daily. These procedures and guidelines must be completed by the 60th day of treatment, and must be completed for other patients requiring more intensive oversight as deemed appropriate by the primary or treating provider.
- Multidisciplinary Components. Management of chronic pain is an interdisciplinary process. Pain management issues are included in topics of discussion during interdisciplinary care conferences as appropriate. Every effort should be made to communicate information to all members of the health care team regarding the patient's pain experience. Multidisciplinary components should be considered core features in the treatment of all patients with chronic non-cancer pain syndromes. These components include but are not limited to:
- Behavioral and psychological therapies.
- Physical therapy.
- Occupational therapy.
- Complementary and alternative therapies.
- Traditional medicine.
- Culturally specific spiritual practices.
- Pharmacological therapies including non-opioid medications and COT.
- Surgical therapies including invasive anesthetic procedures.
- Treatment Plans. Formal treatment plans should be established upon committing to long-term treatment for patients as identified above. Written treatment plans should be based on objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function. The plans should also indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the provider may adjust medication therapy to the individual medical needs of each patient. Other treatment modalities or rehabilitation programs may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
3-30.8 PATIENT EDUCATION
- Non-Opioid Pain Management Therapy. The use of non-opioid medications is a core feature in the treatment of all patients with chronic non-cancer pain syndromes, unless contraindicated. Such medications include but are not limited to: anti-inflammatory medications, non-opioid analgesics, and muscle relaxants; adjuvant pain medications such as neuropathic medications, antidepressants, topical drug therapies; and epidural blocks. Plain buprenorphine (Subutex®) or the combination product with buprenorphine and naloxone (Suboxone®) may also be considered when required certification has been completed and the medication is administered in a monitored setting.
- Consultation. Providers should be willing to refer patients, as necessary, for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those patients who are at risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a co-morbid psychiatric disorder often requires extra care, monitoring, documentation, and consultation with, or referral to, an expert in the management of such patients. Consultation or referral may benefit the following types of patients:
- Patients with complex pain conditions with or without a clear source for their ongoing reports of pain.
- Pregnant or potentially pregnant patients.
- Patients with multiple issues impacting their pain management.
- Patients with history of addiction or substance use disorders.
- Patients requiring in excess of 120 mg morphine equivalents dose daily.
- Patients requiring continued escalation of dosing for adequate pain relief.
- Patients scheduled for surgical interventions.
- Chronic Opioid Therapy and Other Controlled Substance Pain Management. Chronic non-cancer pain therapy with opioid medications is commonly chosen by medical providers and patients to augment other treatment modalities. The use of COT 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.
- In order to assist in providing appropriate, safe, and adequate pain control using opioids, providers must be aware of relative and absolute contraindications to opioid therapy. Once the relative and absolute contraindications have been considered, all patients on 30 mg morphine equivalents daily or more for over 60 days should be evaluated for conversion to a long acting opioid medication. Limited courses of shorter acting opioids are sometimes used as an adjunct for the management of breakthrough pain. Patients should be in communication with their prescribing provider if breakthrough pain requires daily use of shorter acting opioids. This treatment approach often affords better long-term pain control and minimizes dosing. If, however, the patient demonstrates an observed allergy or significant intolerance to the long-acting medication, short-acting opioid therapy may be used in his or her chronic pain treatment plan.
- The amount and frequency of opioid medication administered will be determined by the primary treating provider. Care should be given to appropriately balance the use of longer acting medications with short- acting "rescue" medication.
- Providers should proactively address anticipated side effects from the use of COT through patient education and appropriate medical interventions.
- If escalation of opioid dosages does not lead to appreciable improvement in the chronic non-cancer pain or in the patient's overall daily function, the provider may reduce the opioid dosage or discontinue it entirely. When initiating discontinuation or dose reduction of ineffective COT, patients should be offered appropriate supports including detoxification support and appropriate non-opioid pain management therapies.
- Methadone. Methadone is a potentially lethal medication with complex pharmacokinetic and pharmacodynamic parameters. Before attempting to prescribe methadone, clinicians must be appropriately trained and experienced in its use and/or an appropriate pain clinic consultation obtained. Because of potential cardiac toxicity, a patient's medical assessment must include a baseline (and periodic) electrocardiogram. Patients being treated with methadone must be closely monitored.
3-30.9 CONTINUUM OF CARE
- Providers. Providers will convey to the patient that the safe and optimal management of pain is a primary goal of patient care and is consistent with the IHS mission and values. Patient education includes but is not limited to:
- Types of pain patients actually or potentially may experience.
- Pain control mechanisms available.
- Potential limitations of pain management and treatment.
- Potential side effects of pain management treatment.
- Patients Who Are Pregnant. Patients who are either pregnant or anticipating pregnancy should be counseled on the implications of fetal exposure to COT and other prescribed medications, including neonatal abstinence syndrome, and appropriately referred as necessary.
- Potential Impairment. Patients should be counseled on potential impairment due to COT while driving, performing physically hazardous tasks, operating dangerous equipment or machinery, and the dangers of concurrent use of alcohol and/or illicit drugs.
- Appropriate Storage or Disposal. Patients should be counseled on the appropriate storage and disposal of medications in order to minimize the risk for misuse, abuse, or diversion.
- Patients, Family Members, and Caregivers. Patients, family members, and caregivers including any involved significant others will receive education provided by the staff regarding management of pain. They will be helped to understand their decision-making role in formulating the pain management plan.
3-30.10 COMPLIANCE, OVERSIGHT, AND STATE DATABANK REPORTING
- Consistent Medical Treatment by One Provider. Whenever possible, patients will receive chronic pain management from one consistent provider. In cases where an appointment with the primary treating provider is not available, patients may be assessed and treated by alternate medical providers. In such circumstance, an alternate provider may prescribe some, all or none of opioid medications for up to 30 days or until an appointment with the primary pain treating provider is available, whichever comes first. Under these circumstances, treatment with COT is based on the alternate provider's medical evaluation and clinical judgment. 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 visit/re evaluations for continued pain management until an appointment with the primary treating provider is available. Whenever possible, primary pain treatment providers will attempt to coordinate care with alternate providers for their foreseen absence.
- Opioid Treatment is not permitted if a Consistent Medical Provider is Not Available. Where a consistent provider or provider team is not available, entering into COT is strongly discouraged.
- Patient Treatment Should be Reviewed at Least Every 3 Months. At reasonable intervals based on the individual circumstances of the patient, but at least every 3 months, the provider should review the course of treatment and any new information about the etiology of the pain. 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 the patient's pain intensity and improved physical and psychosocial function including ability to work, need for healthcare resources, participation in activities of daily living, and quality of social life.
- If Treatment Goals Are Not Achieved. If treatment goals are not being achieved despite medication adjustments, providers should reevaluate the diagnosis and the appropriateness of continued treatment or discontinuation of certain medications. All treating providers are expected to monitor the patient's ability to safely self-manage medication usage and related treatment plans.
- Referral to a Chronic Pain Management Clinical Review Committee. Referral to the facility, Service Unit, or Area Chronic Pain Management Clinical Review Committee or its equivalent, and/or internal or contracted pain specialists may be made if additional assessment or consultation and treatment are required beyond the capacity of the provider, pain management team, or facility.
- Medication Refills and Proxy Medication Dispensing. Areas and/or facilities must establish pharmacy policies to address management of COT medication refills. In particular, lost or stolen prescriptions, early or missed refills, and proxy medication dispensing should be addressed. Emergency departments and urgent care settings are not appropriate for managing COT and should not dispense opioid medications to cover COT.
- Drug Abuse Screening and Medication Counts. Patients on COT will be required to submit to both scheduled and unscheduled urine and/or blood drug screens and medication counts upon a providers' request. Urine drug screens are recommended at initiation of the treatment contract and periodically every 6-12 months thereafter, as appropriate. The screen may be collected at a provider visit or ordered by other health professionals (e.g., nurse or pharmacist) before medication dispensing. Urine drug screens such as the U.S. Department of Transportation screening tests and other confirmatory tests can be used.
If positive, appropriate action will be taken by the primary or treating provider, the pain management team, or through direction of the Chronic Pain Management Clinical Review Committee.
- Management of COT Agreement and Other Patient Policy Violations. On occasion, patients will be discovered to be in violation of their COT agreement for concerns such as overutilization, diverting medications, obtaining unreported outside prescriptions for opioids, or having confirmed urine or blood drug screens for drugs of abuse. In such cases, the decision to discontinue the opioid component of the chronic pain management plan may be made by the patient's primary pain management provider, other treating medical provider, or the pain management team as appropriate.
Unless it is determined that extenuating circumstances exist, rapid tapering, detoxification or immediate discontinuation of the opioid supported by symptomatic medications for opioid withdrawal, if indicated, will be initiated.
Providers should never abandon a patient upon discontinuing opioid treatment but make reasonable efforts to find alternate treatment options for the patient. Documentation of alternative treatment options offered and the patient's acceptance or refusal should be entered in the medical record.
- Consideration for Restarting Chronic Opioid Therapy. Restarting COT for patients with a prior pain policy or COT agreement violation or after treatment has been discontinued by a provider for medical reasons, such as addiction or unsafe use, will only be considered after consultation with the Chronic Pain Management Clinical Review Committee to determine if the violation issues or medical concerns have been acceptably addressed.
- New Provider Orientation.
- All new provider staff shall attend an orientation on associated local policies and guidelines.
- A copy of Part 3, Chapter 30, "Chronic Non-Cancer Pain Management," Indian Health Manual, shall be provided to all new provider staff before or at the orientation.
- The provider's supervisor shall note that the provider has been appropriately oriented in the employee's local personnel file.
- United States Drug Enforcement Administration Physician Manual. Providers are referred to the Physician Manual of the U.S. Drug Enforcement Administration and relevant State medical board documents for specific regulations governing controlled substances.
- Chronic Pain Management Clinical Review Committee. All Service Units must establish Chronic Pain Management Clinical Review Committees which meet regularly to review the care of patients on COT. Providers prescribing and directing care remain ultimately responsible for the appropriate use and management of such medications for their patients, but this responsibility should be understood in the context of a system of care that supports safe, effective care, and includes the provider, the pain management team, and the Chronic Pain Management Clinical Review Committee.
- Policy Compliance Oversight. 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. Mortality and morbidity review policies should include procedures for the review and investigation of deaths related to internally prescribed and managed opioids. Oversight assures that patients are being adequately treated, that controlled substances are not being abused or diverted, and that Federal regulations are being adhered to.
- Reconsideration Request. Any patient who feels that implementation of this policy has been inappropriate for any reason, such as discontinuation of medications for violation of a treatment agreement, or limitations of medication dosages, may file a complaint or grievance in accordance with the locally established procedures.
- State Controlled Prescription Drug Monitoring Programs. To the extent permitted by Federal law, IHS facilities are encouraged to implement regular reporting of controlled substance data to their local State database as soon as technically feasible. Facilities that serve patients residing in multiple States are encouraged to work with each State to implement regular reporting. This reporting shall be considered part of IHS' prescription drug monitoring program as authorized by 25 U.S.C. 1680.
Providers are encouraged to register with the PDMP in the State of his/her practice. All PDMP patient data should be requested prior to patient appointment with every new patient encounter to facilitate meaningful interactions AND randomly for patients receiving chronic controlled substance prescriptions as part of a periodic review. The data can be used to check for:
- Aberrant behavior or undertreated pain.
- Misuse or multiple prescribers.
- Drug interactions or other harm.
- Use reports to verify compliance with pain agreements.
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