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PAIN MANAGEMENT Kirk L. Kinard, D.O September 26, 2014 Disclosures Southern Pain Society- Board of Directors SAS Research- study investigator (compounded topical analgesics) ISIS, AAPM, SPS, ASA- active member MidSouth Pain Treatment Center- Medical Director of Oxford location (Southaven-MS, Germantown-TN, Jackson-TN) Objectives Incorporate knowledge of more accurate “pain” terminology in your documentation, development of targeted treatment strategies, and verbal communications with pain patients Identify how many of your own practice habits may be contributing to the growing prescription drug abuse problem in the U.S. Modulate therapy for chronic pain patients by better addressing psychological and behavioral issues Utilize available screening tools to risk stratify patients prior to initiating opioid therapy Modify your practice standards to meet both state and federal expectations for treating chronic pain patients Apply knowledge of multidisciplinary approaches to chronic pain management to assess your current limitations and assist with a more timely and appropriate referral to a pain medicine specialist “Pain Clinic” On September 24, 2013, the Board adopted an amendment to the Administrative Code Part 2640, Chapter 1: Regulations Pertaining to Prescribing, Administering and Dispensing of Medication, to amend the registration of Pain Management Medical Practices, Rule 1.15. Physicians whose practice meet the definition of a Pain Practice may not operate in Mississippi without the required registration from the Mississippi State Board of Medical Licensure. A Pain Management Medical Practice is defined in the regulation as a public or private medical practice that provides pain management services to patients, a majority (more than 50%) of which are issued a prescription for, or are dispensed, opioids, barbiturates, benzodiazepines, carisoprodol, butalbital compounds, or tramadol for more than one hundred eighty days (180) days in a twelve month period. The physician owner/operator/employee of a Pain Management Medical Practice must register with the Mississippi State Board of Medical Licensure. Certificates, once issued, are not transferable or assignable. Only the primary physician owner is required to register with the Board. All practitioners/employees associated with clinic in the treatment of pain management patients, whether in the capacity as an owner / practitioner / employee should be listed on the application. Each practice requires a separate application/certificate. What/Who is a “Pain Specialist”? The American Board of Medical Specialties AMBS is the primary physician certification organization in the United States certifies pain medicine fellowship programs that result in subspecialty certification in Pain Medicine Anesthesiology, PM&R, Neurology, Psychiatry The American Board of Pain Medicine ABPM is not affiliated with the ABMS does not oversee fellowship training programs ABPM administers practice-related examination for certification in Pain Medicine to qualified candidates who have achieved specified requirements Early Approaches to Pain Management Surgical/Procedural Trepanning (headache) Blood letting (acute side pain) Stimulation Eels Acupuncture Topicals Oil, sulfur rubs Life Style Change Sexual abstinence Exercise Hot spas Heliotherapy, rest WHO Analgesic Ladder The Problem of Undertreated Pain WHO: Undertreated pain is America’s #1 health problem # of patients with chronic pain in the U.S. exceeds diabetes, heart disease and cancer combined National Center for Health Statistics. Health, United States, 2006 with Chartbook on Trends in the Health of Americans. Hyattsville, MD: US Department of Health and Human Services; 2006:68–71 Physiological effects of Pain Increased catabolic demands: poor wound healing, weakness, muscle breakdown Decreased limb movement: increased risk of DVT/PE Respiratory effects: shallow breathing, tachypnea, cough suppression increasing risk of pneumonia and atelectasis Increased sodium and water retention (renal) Decreased gastrointestinal mobility Tachycardia and elevated blood pressure, myocardial ischemia, dysrhythmia, hypercoagulation (CV) Endocrine: hyperglycemia Immunologic: Decrease natural killer/lymphocyte? cell counts Psychological effects of Pain Negative emotions: anxiety, depression, irritability, rage, anhedonia Sleep deprivation Existential suffering: may lead to patients seeking active end of life. Why is pain so difficult to manage? Poor Assessment Complicated Physiology Secondary Psychological Manifestations Co-morbid Pathologies Compliance Managed Care Limitations Regulatory Concerns Limited Analgesic Options Lack of knowledge Criminal Charges for Overtreatment of Pain Almost all are extreme Good clinicians practicing at extremes of the normal curve Well intentioned clinicians practicing below standard of care Clinicians practicing outside of medicine- Illegal activities Taxonomy of Pain “opium” is a Greek word meaning “juice,” or the exudate from the poppy “opiate” is a drug extracted from the exudate of the poppy (codeine, morphine) “opioid” is a natural semisynthetic (heroin) or synthetic drug (all others) that binds to opioid receptors producing agonist effects Taxonomy of Pain Acute/Chronic Pain Tolerance Dependence Addiction/Pseudo-addiction Pain Coping/Chemical Coping Pharmacogenetics Morphine equivalents/Opioid Conversions Opioid Rotation Opioid Induced Hyperalgesia (OIH) End of Dose Failure (EODF) Central/Peripheral Sensitization Nociceptive/Neuropathic Pain Tolerance decreasing pain relief with the same dosage over time Not an impediment to long-term opioid use Experience with treating cancer pain has shown that what initially appears to be tolerance is usually progression of the disease. Dependence WHO and DSM-IV-TR clinical guidelines for a definite diagnosis of "dependence" require stricter criteria Physical Dependence A physiological withdrawal state when drug use is stopped or reduced, as evidenced by: the characteristic withdrawal syndrome for the substance (opioids) chills, goose bumps, profuse sweating, increased pain, irritability, anxiety, agitation, and diarrhea use of the same (or a closely related) substance with the intention of relieving or avoiding withdrawal symptoms Addiction A primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors. Charicterized by one or more of the following: Impaired control over drug use Compulsive use Continued use despite harm Craving Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and should not be considered addiction. Addiction vs. Analgesia Patients with addiction take increasing amounts of abuseable drugs Function does not improve-usually worsens Patients with analgesia usually find a stable (moderate) dose and Improved QOL Pain doesn’t completely abate balance of least pain/most function Function improves Pseudo-addiction Due to insufficient analgesia Under dosing/EODF Non-opioid responsive pain Tolerance Opioid Induced Hyperalgesia (OIH) Looks like addiction Irritability Overutilization Higher consumption of staff time Requests for “what works for me” Opioid-Induced Hyperalgesia Patients become “sensitized” to pain Allodynia Hyperalgesia Not a phenomenon exclusive to high dose/intrathecal therapy Pain diminishes with opioid tapering May present as pseudo-addiction General Perspective of Opioids Opioids seem to work for some Opioids seem to be ineffective for some Opioids seem to be problematic for some It may be difficult to know who is in which group Consequences of Opioid Therapy Did You Know? CDC Report Nearly 7 million Americans are abusing prescription drugs More than the number who are abusing cocaine, heroin, hallucinogens, Ecstasy, and inhalants Combined! Methadone deaths increased 7X Opioid Deaths 2x cocaine 5X heroin 8O % increase in just 6 years Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. CDC’s Issue Brief: Unintentional Drug Poisoning in the United States. http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/brief.htm. 2010 Methadone: Good, Bad, and Ugly Unique analgesic properties (NMDA) Low euphoria index Cheap long t1/2 QTc Prolongation According to CDC 2% of all opioids prescribed for pain in US 30% of opioid OD deaths in US Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. CDC’s Issue Brief: Unintentional Drug Poisoning in the United States. http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/brief.htm . 2010 Alarming Rise in Teen Use Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. CDC’s Issue Brief: Unintentional Drug Poisoning in the United States. http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/brief.htm. 2010 OPIOIDS Formulations Short Acting Intermediate Long Acting Route PO IV/IM Transdermal/Buccal/Sublingual Neuraxial Intranasal Efficacy of Opioids Summary of evidence: Many trials found opioids moderately effective for pain relief and slightly to moderately effective for functional outcomes compared to placebo in patients with chronic noncancer pain. almost all data are on short-term (≤12 weeks) outcomes (level of evidence: high). About half of patients discontinue opioids in long-term primarily observational studies (level of evidence: moderate). Compared to antidepressants or non-steroidal anti-inflammatory drugs, one systematic review found oxycodone and morphine slightly more effective for pain relief in two trials, but found no differences between propoxyphene, codeine, or tramadol and the non-opioids (6 trials) (level of evidence: moderate). APS-AAPM Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain www.AmericanPainSociety.org Complexities of Opioid Therapy Variable response Multiple formulations/doses Drug-drug interactions Extensive documentation Regulatory concerns, fears (rational?) Side effects OIH (hyperalgesia) Abuse, misuse, diversion 2013 FSMB Model Policy The revised Model Policy makes it clear that the state medical board will consider inappropriate management of pain, particularly chronic pain, to be a departure from accepted best clinical practices, including, but not limited to the following: Inadequate attention to initial assessment to determine if opioids are clinically indicated and to determine risks associated with their use in a particular individual with pain Inadequate monitoring during the use of potentially abusable medications Inadequate attention to patient education and informed consent Unjustified dose escalation without adequate attention to risks or alternative treatments Excessive reliance on opioids, particularly high dose opioids for chronic pain management Not making use of available tools for risk mitigations Patient Selection!!!!!!! Medical Necessity Risk factors for abuse Co-morbidity Failure of conservative alternatives Informed consent/education Primary endpoint Exit strategy What tools should we use for screening? Thorough history Physical examination Communication with referring providers Lab/Imaging Communication with pharmacies PDMP Opioid agreement Questionnaires/Psych Assessment!! SOAPP-R, ORT, CAGE, COMM, DAST… Urine toxicology screens POC (IA),GC-MS, LC-MS 2013 FSMB Model Policy Patient Evaluation and Risk Stratification: Assessment of the patient’s personal and family history of alcohol or drug abuse and relative risk for medication misuse or abuse should be part of the initial evaluation Ideally completed prior to a decision as to whether to prescribe opioid analgesics Done through a careful clinical interview Treatment of a patient who has a history of substance use disorder should, if possible, involve consultation with an addiction specialist before opioid therapy is initiated (and follow-up as needed) Also should inquire into any history of physical, emotional or sexual abuse, because those are risk factors for substance misuse Screening Questionnaires Should be used with/without formal risk assessment A Comparison of Various Risk Screening Methods in Predicting Discharge From Opioid Treatment. Clin J Pain Volume 28, Number 2, February 2012 Could not identify a “best ” screening tool Tailor to specific circumstance SOAPP-R “less susceptible to deception” Screening Questionnaires BRI (Brief Risk Interview) DIRE (Diagnosis, Intractability, Risk, Efficacy score) ORT (Opioid Risk Tool) COMM (Current Opioid Misuse Measure) PMQ (Pain Medication Questionnaire) Highly touted http://www.opioidrisk.com/node/507. SOAPP-R Screener and Opioid Assessment for Patients with Pain - Revised 24-item patient-completed questionnaire revision of the SOAPP (Butler, Fernandez, Benoit, et. al., 2008). Uses a five-point rating scale in asking questions about such topics as: impulsivity, legal problems, past substance abuse and past sexual abuse classifies patients in risk categories of Low and High risk while it refers to a Medium category in the SOAPP-R manual, there has been no validation on the use of the Medium category One link to a copy is: http://www.opioidrisk.com/node/610 Screening Questionnaires http://www.integration.samhsa.gov/clinical- practice/screening-tools Drug/Alcohol Use Depression Bipolar Disorders Anxiety Suicide Trauma Documentation- Initial Workup Required H&P- touch the patient! OSA, COPD, CHF! Diagnostic/Therapeutic/Lab results Treatment objectives/Endpoint Complete relief not likely Improved function/QOL Informed Consent/Agreement Women of child-bearing age/pregnant! Planned Treatments/Meds (date, type, #,dose) Instructions UDS results DIAGNOSIS Adapted from: Schneider J. Opioid Prescribing Part I: A Practical Guide to Appropriate Documentation. Prac Pain Mgmt.2014;14(1):34-37 Documentation- Initial Workup Recommended Additional Old Records- especially relevant to complaint Pain Intensity Level- each visit Level of Function/QOL- each visit Pt. subjective complaints/Providers observations Pt. explanation for any aberrant behaviors (early refills, lost/stolen, multiple pharmacies, etc.) PDMP Results (mandatory in TN) Description of provider’s thought process when making changes/reccs, ordering tests, interpreting UDS results Adapted from: Schneider J. Opioid Prescribing Part I: A Practical Guide to Appropriate Documentation. Prac Pain Mgmt.2014;14(1):34-37 Documentation- Follow up “5 As” of Pain Medicine Analgesia Adverse reactions Activity Aberrant behavior Affect Pill counts Physical Exam Review Terms So, I think the patient has too many red flags…and they “just took their last dose yesterday”…Now what? A patient having been prescribed opioids by a previous provider is not, in and of itself, a reason to continue opioids Weaning opioids is not always indicated when they are to be discontinued opioids are not present in UDS drug diversion suspected (“lost or stolen”, doctor shopping, etc.) When additional prescribing thought to constitute more risk to the patient or to the community than the potential for withdrawal syndrome Offer a treatment plan/referral which does not include or promise a prescription for a controlled substance Clonidine can be administered 0.1-0.2mg orally every 6 hours or with a transdermal patch at 0.1mg/24hours. Hypotension and anticholinergic side effects may be encountered http://www.samhsa.gov/treatment/ Substance Abuse and Mental Health Services Administration Hotlines Treatment Facility Locators Opioid Rotation Example: A patient is receiving 200mg of oral morphine daily (chronic dosing) because of side effects a switch is made to oral hydromorphone 25 - 35mg daily This represents a 33 to 50 percent reduction in dose compared to the calculated 50mg conversion dose produced via the equianalgesic calculator. This new regimen can then be titrated to effect LOW AND SLOW!!!! Incomplete Cross-Tolerance tolerance to a currently administered opiate that does not extend completely to other opioids will tend to lower the required dose of the second opioid exists between all of the opioids and the estimated difference between any two opiates could vary widely inherent dangers of using an equianalgesic table and the importance of viewing the tabulations /dosing tables as estimates reducing the dose of the new opiate by 33 to 50 percent to account for this incomplete cross-tolerance. Morphine Equivalent Dose (MED) Equipotent dose of any opioid in terms of morphine Only “Pain Specialist” may prescribe MED >200mg in TN > 120mg MED must be seen by a physician in TN 11 times more likely to die of overdose Used for opioid rotation No MED chart can adequately account for the patient-specific responses Adverse events from taking any opioid can be dose-independent and may begin at low doses. Factors affecting variable responses: age, gender, genetic variability in drug metabolism, drug-drug interactions, opioid tolerance and organ dysfunction such as renal and hepatic impairment, adrenal insufficiency, hypothyroidism, and abnormal levels of protein binding Morphine Equivalents Equianalgesic Dosing Use guides to equianalgesic dosing such as the Philadelphia VA guidelines Not reliable for fentanyl and buprenorphine PATCHES Methadone may present special concerns and avoiding its use may be warranted if not familiar with using methadone in chronic pain The VA has a special protocol for methadone prescribing because of safety concerns How useful is urine screening? Recommendation by FSMB POC immunoassay for illicit drugs and opioid class High “cut-off” values = less sensitive than confirmation with GCM or LCM (mass spectrometry) Standard of Care? Confirmation necessary? Metabolite for timing of dose Class breakdown Be aware of false+/- (communicate with lab) Urine Drug Screening Baseline Document Last dose expect neg if > 5 half-lives/PRN dosing Dipstick --- Confirm Follow-up Random?- double void technique Better off with random pill counts Every 6 months minimum Neonatal Abstinence Syndrome Black Box Warning on CII opioids for women of childbearing age Informed consent Taper before third trimester Mother may be tried for criminal negligence in some states Immunity if enter into treatment program before birth (TN) Rescue Treatment- Opioid Toxicity Naloxone Direct Mu receptor antagonist IV Naltrexone PO, Auto-injector, Atomizer Mist Beware of recrudescence! Opioid Tapering Safe tapering may follow several general paths (2 to 3 week tapering regimen should be adequate in most cases) Reduce the each daily dose by 10% Reduce the dose by 20% every 3-5 days Reduce the dose by 25% per week Avoid reducing the daily dose by > 50% at any given interval Opioids in Renal Failure Opioid Comments for Patients With ESRD Morphine • • Oxycodone • • Comments for Patients Requiring Dialysis Active metabolites accumulate and can • contribute to adverse CNS effects; not • recommended If necessary, dose reduction and careful monitoring for adverse effects is imperative Minor, but active and potent, metabolite oxymorphone may accumulate Dose reduction and careful monitoring for adverse effects is recommended • • Accumulation of active metabolites; not recommended Dialysis effective in removing both parent drug and active metabolites, although CNS depressant effect of morphine-6-glucuronide may persist after dialysis Variable reports of adverse effects in patients requiring dialysis; use with extreme caution Limited data; likely at least partially dialyzed Fentanyl No active metabolites; likely safe No active metabolites; likely safe Not likely to be removed by dialysis Meperidine • Risk of adverse effects from accumulation of neuroexcitatory metabolites; not recommended • • Active neuroexcitatory metabolites; not recommended Limited data; likely removed by dialysis Methadone • • No active metabolites; likely safe As in patients without renal disease, standard dosing precautions apply No active metabolites, likely safe Not dialyzed; because of long and variable half-life of parent compound, caution indicated Hydrocodone/ Hydromorphone • Hydrocodone is metabolized to hydromorphone; the neuroexcitatory 3glucuronide metabolite may accumulate Dose reduction and careful monitoring recommended Metabolites may accumulate but can be effectively removed with dialysis; use caution and adjust dose as necessary One active metabolite, norbuprenorphine, with minor analgesic activity and ceiling effect for respiratory depression Limited data; likely safe • • • Buprenorphine • • Limited data; likely safe Limited data; parent compound and metabolite not likely to be dialyze ANALGESICS Management Modalities Pharmacotherapy NSAIDs Steroids Co-analgesics Opioids Anticonvulsants Antidepressants Muscle Relaxants Others ADJUVANT ANALGESICS ANTIDEPRESSANTS Certain antidepressants have analgesic properties independent of their effects on mood The onset of analgesic effect is faster than the onset of antidepressant effect SNRIs appear superior I think Descartes was onto something ADJUVANT ANALGESICS ANTICONVULSANTS “Membrane stabilizers” Preferable initial agent for neuropathic pain gabapentin, tegretol, topirimate, pregabalin ADJUVANT ANALGESICS OTHER Baclofen Tizanadine Nortriptyline Careful with off-label use (APN limitation) ADJUVANT ANALGESICS TOPICAL Lidocaine (Patch) NSAIDs (Gel / Patch/ Drops) Capsaicin (Cream/Patch) Compounded Agents (cream) NON-PHARMACOLOGIC THERAPIES Self-Care TENS Acupuncture Psychotherapy Physiotherapy Nerve Blocks/Ablations Spinal Cord/Peripheral Field Stimulation Surgery NON-PHARMACOLOGIC THERAPIES TENS NON-PHARMACOLOGIC THERAPIES Psychotherapy Multiple psychological treatments may be helpful and should be maximized Stress management Relaxation training Hypnosis Cognitive-behavioral therapy Biofeedback Coping Behavior modification Supportive psychotherapy NON-PHARMACOLOGIC THERAPIES Physiotherapy Commonly prescribed techniques Work hardening Exercise PT/OT Massage/Heat/US/Iontophoresis Spinal Manipulation NON-PHARMACOLOGIC THERAPIES Acupuncture PAIN TREATMENT CONTINUUM Diagnosis Oral Medications PT, Exercise, Rehabilitation Behavioral Medicine Corrective Surgery Therapeutic Nerve Blocks Oral Opiates Implantable Pain Management Devices Neurostimulation Intrathecal Pumps Neuroablation Is the pain blockable? WHO Analgesic Ladder “Fourth Step?” Interventional Techniques Interventional Techniques Intraarticular /Bursa Injections Major Joint Sacroiliac Joint Ischial/Trochanteric Bursa Carpal Tunnel Nerve Blocks Ganglion Plexus Peripheral Trigger Point/Botox Spinal Procedures Epidural Steroid/LA Injections Facet Joint Block Discography Vertebro/Kyphoplasty Epidural Adhesiolysis Intradiscal therapies Radiofrequency Neurolysis Percutaneous Disc Decompression/Nucleoplasty CASE 1 20 y/o male track athlete with mechanical LBP Facet Joint Innervation Sacroiliac Joint Implantable Devices Spinal Cord Stimulator Peripheral “field “ Stimulator Intrathecal Pump CONCLUSION Treatment Goals: Use multiple treatment modalities Increase function Reduce pain behaviors/disability behaviors Treatment without unacceptable side effects Total removal of pain may not be possible Know when and how to refer to a specialist So, Dr. Kinard, if you’re so great then why did the patient I referred to you call me on the way home from your office visit asking me to call in a refill for their pain medication? Non-compliance with our plan Functional rehab Psych assessment Missed appointments Inconsistent urine screens Unacceptable/aberrant behavior Ending the Physician-Patient Relationship Appropriate steps to terminate the physician-patient relationship include: 1. Giving the patient or patient’s representative written notice, which may be by certified mail, return receipt requested, or other reasonable proof. A copy of the letter should be included in the medical record. 2. Providing the patient with a brief and valid reason for terminating the relationship. 3. Agreeing to continue to provide care for a reasonable period of time (at least 30 days) in order to allow the patient to obtain care from another physician. 4. Providing recommendations to help the patient locate another physician of like specialty. 5. Offer to transfer records to the new physician upon signed authorization and include an authorization form with the letter. 6. A physician assistant or nurse practitioner may not independently terminate the physicianpatient relationship. SWWW.MSBML.MS.GOV/POLICIES Resources FSMB.ORG MSBML.MS.GOV DEADIVERSION.USDOJ.GOV SAMHSA.GOV/TREATMENT Substance Abuse and Mental Health Services Admn. THEACPA.ORG PAINMED.ORG American Academy of Pain Medicine Guidelines, forms, references, educational patient resources References Found as footnote in slide Stated in substance of slide