The Pain Practitioner - The Importance of Collaboration

american academy of pain managemen

The Pain Practitioner Spring 2016

integrated pain management the importance of collaboration

ALSO INSIDE: Interprofessional Pain Management • The War Against Complex Regional Pain Syndrome Avoiding EMR Pitfalls • How to Help a Patient Who is Fearful of Movement, and more!

TW O SOURCES

OF PAIN

O NE SOURCE OF RELIEF

NUCYNTA® ER is the first and only FDA-approved long-acting opioid designed to control both nociceptive pain and the neuropathic pain associated with diabetic peripheral neuropathy (DPN).

NUCYNTA® ER is an opioid agonist indicated for the management of: • pain severe enough to require daily, around-theclock, long-term opioid treatment and for which alternative treatment options are inadequate

Not an actual patient.

• neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate Limitations of Use • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve NUCYNTA® ER for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain • NUCYNTA® ER is not indicated as an as-needed (prn) analgesic

Please see additional Important Safety Information and Brief Summary, including BOXED WARNING, on the following pages.

TIME TO DUAL

PRESCRIBE NUCYNTA® ER FOR ONE SOURCE OF RELIEF • Proven efficacy in chronic low back pain and DPN1,2 - Based on efficacy demonstrated in a prospective, randomized, double-blind, active- and placebo-controlled, multicenter phase 3 chronic low back pain study (N=981) showing significant change in mean pain intensity from baseline in Week 15 (Week 12 of the maintenance phase) vs placebo1 - Based on efficacy demonstrated in a double-blind, parallel-group, enriched-enrollment randomized phase 3 DPN study (N=977) showing significant change in mean pain intensity over the last week of the 12-week, double-blind, maintenance phase vs placebo2 • 5 dosage strengths: 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg3* Individualize dosing based on patient’s prior analgesic treatment experience and risk factors for addiction, abuse, and misuse; titrate as needed to provide adequate analgesia and minimize adverse reactions

COVERED FOR

94%

OF COMMERCIALLY INSURED PATIENTS.‡ PREFERRED FOR UNITEDHEALTH GROUP AND SILVERSCRIPT/ CVS CAREMARK PART D PLANS‡

• Administer NUCYNTA® ER ~q12h3

VISIT NUCYNTA.COM FOR MORE INFORMATION AND TO DOWNLOAD A NUCYNTA® ER SAVINGS CARD† • $0 co-pay for first prescription of NUCYNTA® ER with a $25 co-pay on each additional prescription if eligible†

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL See full prescribing information for complete boxed warning.

• NUCYNTA® ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1) • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole to avoid exposure to a potentially fatal dose of tapentadol. (5.2) • Accidental ingestion of NUCYNTA® ER, especially in children, can result in fatal overdose of tapentadol. (5.2) • Prolonged use of NUCYNTA® ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.3) • Instruct patients not to consume alcohol or any products containing alcohol while taking NUCYNTA® ER because co-ingestion can result in fatal plasma tapentadol levels. (5.4) CONTRAINDICATIONS: Significant respiratory depression; acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment; known or suspected paralytic ileus; hypersensitivity (e.g., anaphylaxis, angioedema) to tapentadol or to any other ingredients of the product; concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days. *Please see full Prescribing Information for DOSAGE AND ADMINISTRATION. †Some restrictions and limitations apply. See full terms and conditions available at NUCYNTA.com. Available to commercially insured and cash-paying patients only. Patients covered by Medicare, Medicaid, or any other state- or federally funded benefit program are excluded. Patients must be 18 years of age or older. This promotion cannot be combined with any other programs, offers, or discounts. Depomed reserves the right to rescind, revoke, or amend this offer without further notice. ‡Source: MMIT 2.0, May 2015.

References: 1. Buynak R, Shapiro DY, Okamoto A, et al. Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase Ill study. Expert Opin Pharmocother. 2010;11(11):17871804. 2. Schwartz S, Etropolski M, Shapiro DY, et al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011;27(1):151-162. 3. NUCYNTA® ER [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2014.

NUCYNTA® ER (tapentadol) IMPORTANT SAFETY INFORMATION (continued) WARNINGS AND PRECAUTIONS: Addiction, Abuse, and Misuse: NUCYNTA® ER contains tapentadol, an opioid agonist and a Schedule II controlled substance that can be abused in a manner similar to other opioid agonists, legal or illicit. There is a greater risk for overdose and death due to the larger amount of tapentadol present in NUCYNTA® ER. Assess risk for opioid abuse or addiction prior to prescribing NUCYNTA® ER. Addiction can occur in patients appropriately prescribed NUCYNTA® ER at recommended doses; in those who obtain the drug illicitly; and if the drug is misused or abused.

Therefore, routinely monitor for signs of misuse, abuse, and addiction. Patients at increased risk (e.g., patients with a personal or family history of substance abuse or mental illness) may be prescribed NUCYNTA® ER, but use in such patients necessitates intensive counseling about the risks and proper use along with intensive monitoring for signs of addiction, abuse, and misuse.

Life-threatening Respiratory Depression: Can occur at any time during the use of NUCYNTA® ER even when used as recommended.

Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. To reduce the risk of respiratory depression, proper dosing and titration are essential. Overestimating the dose when converting patients from another opioid product can result in fatal overdose with the first dose. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status.

Neonatal Opioid Withdrawal Syndrome: Prolonged use of NUCYNTA® ER during pregnancy can result in withdrawal signs in the neonate, which may be life-threatening and require management according to protocols developed by neonatology experts. Neonatal opioid withdrawal syndrome presents as poor feeding, irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, rigidity, seizures, vomiting, diarrhea, and failure to gain weight.

Interactions With Central Nervous System Depressants: Hypotension, profound sedation, coma, respiratory depression, and death may result if NUCYNTA® ER is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, tranquilizers, general anesthetics, neuroleptics, other opioids). When considering the use of NUCYNTA® ER in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. If the decision to begin NUCYNTA® ER is made, start with NUCYNTA® ER 50 mg every 12 hours, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.

Use in Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients in the lower range of recommended doses.

Closely monitor these patients, particularly when initiating and titrating NUCYNTA® ER and when given concomitantly with other drugs that depress respiration.

Use in Patients With Chronic Pulmonary Disease: Patients with significant chronic obstructive pulmonary disease or cor pulmonale and patients having a substantially decreased respiratory reserve, hypoxia, hypercarbia, or pre-existing respiratory depression, should be monitored for respiratory depression particularly when initiating therapy and titrating with NUCYNTA® ER. Consider the use of alternative nonopioid analgesics in these patients.

Hypotensive Effect: May cause severe hypotension. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor for signs of hypotension during dose initiation or titration.

Avoid use in patients with circulatory shock; may cause vasodilation that can further reduce cardiac output and blood pressure.

Use in Patients With Head Injury or Increased Intracranial Pressure: Monitor patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy. NUCYNTA® ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure.

Opioids may also obscure the clinical course in a patient with a head injury.

Seizures: May aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures. Monitor patients with a history of seizure disorders for worsened seizure control during therapy.

Serotonin Syndrome: Cases of life-threatening serotonin syndrome have been reported with the concurrent use of NUCYNTA® ER and serotonergic drugs. Serotonergic drugs comprise selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, drugs that affect the serotonergic neurotransmitter system, and drugs that impair metabolism of serotonin (including MAOIs). This may occur within the recommended dose. Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g.,

tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) and can be fatal. If concomitant treatment with SSRIs, SNRIs, TCAs, or triptans is clinically warranted, careful observation of the patient is advised, particularly when initiating or titrating the dose.

Use in Patients With Gastrointestinal (GI) Conditions: Contraindicated in patients with Gl obstruction including paralytic ileus; may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Avoidance of Withdrawal: Withdrawal symptoms (e.g., anxiety, sweating, insomnia, restlessness, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection) may occur: • After abrupt discontinuation or a significant dose reduction of NUCYNTA® ER in physically dependent patients. When discontinuing NUCYNTA® ER, gradually taper the dose.

• If mixed agonist/antagonist (e.g., butorphanol, nalbuphine, pentazocine) and partial agonist (e.g., buprenorphine) analgesics are used in patients who have received or are receiving NUCYNTA® ER. Avoid use with mixed agonists/ antagonists and partial agonists.

• If opioid antagonists (e.g., naloxone, nalmefene) are administered in physically dependent patients. Administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

Driving and Operating Heavy Machinery: May impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of NUCYNTA® ER and know how they will react to the medication.

Hepatic Impairment: Avoid use in patients with severe hepatic impairment (Child-Pugh Score 10 to 15). In patients with moderate hepatic impairment (Child-Pugh Score 7-9), initiate treatment with NUCYNTA® ER 50 mg no more than once every 24 hours, with a maximum dose of 100 mg per day.

Monitor for respiratory and CNS depression when initiating and titrating NUCYNTA® ER. Renal Impairment: Use in patients with severe renal impairment (CLCR <30 mL/min) is not recommended due to accumulation of a metabolite formed by glucuronidation of tapentadol. The clinical relevance of the elevated metabolite is not known.

DRUG INTERACTIONS Alcohol: See BOXED WARNING. Muscle Relaxants: Monitor patients receiving muscle relaxants and NUCYNTA® ER for signs of respiratory depression that may be greater than otherwise expected. Tapentadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Anticholinergics: Use with anticholinergic products may increase the risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

USE IN SPECIFIC POPULATIONS Pregnancy/Nursing Mothers: Pregnancy Category C. NUCYNTA® ER should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms. Observe newborns for symptoms of neonatal opioid withdrawal syndrome. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of NUCYNTA® ER is stopped.

Labor and Delivery: Opioids cross the placenta and may produce respiratory depression in neonates. NUCYNTA® ER is not for use in women during and immediately prior to labor, when shorter-acting analgesics or other analgesic techniques are more appropriate.

Use in Elderly, Renal Impairment, and Hepatic Impairment: See WARNINGS AND PRECAUTIONS. DRUG ABUSE AND DEPENDENCE: See BOXED WARNING OVERDOSAGE: Institute supportive measures to manage respiratory depression, circulatory shock, and pulmonary edema as required. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression.

ADVERSE REACTIONS: In clinical studies, the most common (≥10%) adverse reactions were nausea, constipation, vomiting, dizziness, somnolence, and headache.

Select Postmarketing Adverse Reactions: Anaphylaxis, angioedema, and anaphylactic shock have been reported very rarely with ingredients contained in NUCYNTA® ER. Advise patients how to recognize such reactions and when to seek medical attention. Panic attack has also been reported.

Please see Brief Summary, including BOXED WARNING, on the following pages. © July 2015, Depomed, Inc. All rights reserved. APL-NUCX-0029 Rev.2

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION This does not include all the information needed to use NUCYNTA® ER safely and effectively.

See full Prescribing Information for NUCYNTA® ER. INDICATIONS AND USAGE NUCYNTA® ER is indicated for the management of: • pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate • neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Usage • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve NUCYNTA® ER for use in patients for whom alternative treatment options (e.g., nonopioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

• NUCYNTA® ER is not indicated as an as-needed (prn) analgesic.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND INTERACTION WITH ALCOHOL See full prescribing information for complete boxed warning.

• NUCYNTA® ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1) • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole to avoid exposure to a potentially fatal dose of tapentadol. (5.2) • Accidental ingestion of NUCYNTA® ER, especially in children, can result in fatal overdose of tapentadol. (5.2) • Prolonged use of NUCYNTA® ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.3) • Instruct patients not to consume alcohol or any products containing alcohol while taking NUCYNTA® ER because co-ingestion can result in fatal plasma tapentadol levels. (5.4) CONTRAINDICATIONS Significant respiratory depression; acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment; known or suspected paralytic ileus; hypersensitivity (e.g., anaphylaxis, angioedema) to tapentadol or to any other ingredients of the product; concurrent use of monoamine oxidase inhibitors (MAOIs) or use within the last 14 days.

WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: NUCYNTA® ER contains tapentadol, a Schedule II controlled substance. As an opioid, NUCYNTA® ER exposes users to the risks of addiction, abuse, and misuse. As modified-release products such as NUCYNTA® ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of tapentadol present.

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed NUCYNTA® ER and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing NUCYNTA® ER, and monitor all patients receiving NUCYNTA® ER for the development of these behaviors or conditions.

Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e.g., major depression).The potential for these risks should not, however, prevent the prescribing of NUCYNTA® ER for the proper management of pain in any given patient. Patients at increased risk may be prescribed modified-release opioid formulations such as NUCYNTA® ER, but use in such patients necessitates intensive counseling about the risks and proper use of NUCYNTA® ER along with intensive monitoring for signs of addiction, abuse, and misuse.

Abuse or misuse of NUCYNTA® ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of tapentadol and can result in overdose and death.

Opioid agonists such as NUCYNTA® ER are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing NUCYNTA® ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression has been reported with the use of modified release opioids, even when used as recommended.

Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of NUCYNTA® ER, the risk is greatest during the initiation of therapy or following a dose increase.

Closely monitor patients for respiratory depression when initiating therapy with NUCYNTA® ER and following dose increases. To reduce the risk of respiratory depression, proper dosing and titration of NUCYNTA® ER are essential. Overestimating the NUCYNTA® ER dose when converting patients from another opioid product can result in fatal overdose with the first dose.

Accidental ingestion of even one dose of NUCYNTA® ER, especially by children, can result in respiratory depression and death due to an overdose of tapentadol.

Neonatal Opioid Withdrawal Syndrome: Prolonged use of NUCYNTA® ER during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn.

Interactions with Central Nervous System Depressants: Patients must not consume alcoholic beverages or prescription or non-prescription products containing alcohol while on NUCYNTA® ER therapy. The co-ingestion of alcohol with NUCYNTA® ER may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol.

Hypotension, profound sedation, coma, respiratory depression, and death may result if NUCYNTA® ER is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids).

When considering the use of NUCYNTA® ER in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient’s use of alcohol or illicit drugs that cause CNS depression. If the decision to begin NUCYNTA® ER is made, start with NUCYNTA® ER 50 mg every 12 hours, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant.

Use in Elderly, Cachectic, and Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Therefore, closely monitor such patients, particularly when initiating and titrating NUCYNTA® ER and when NUCYNTA® ER is given concomitantly with other drugs that depress respiration.

Use in Patients with Chronic Pulmonary Disease: Monitor for respiratory depression those patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercarbia, or pre-existing respiratory depression, particularly when initiating therapy and titrating with NUCYNTA® ER, as in these patients, even usual therapeutic doses of NUCYNTA® ER may decrease respiratory drive to the point of apnea.

Consider the use of alternative non-opioid analgesics in these patients if possible.

Hypotensive Effect: NUCYNTA® ER may cause severe hypotension. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressantdrugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dose of NUCYNTA® ER. In patients with circulatory shock, NUCYNTA® ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of NUCYNTA® ER in patients with circulatory shock.

Use in Patients with Head Injury or Increased Intracranial Pressure: Monitor patients taking NUCYNTA® ER who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with NUCYNTA® ER. NUCYNTA® ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury.

Avoid the use of NUCYNTA® ER in patients with impaired consciousness or coma.

Seizures: NUCYNTA® ER has not been evaluated in patients with a predisposition to a seizure disorder, and such patients were excluded from clinical studies. The active ingredient tapentadol in NUCYNTA® ER may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during NUCYNTA® ER therapy.

Serotonin Syndrome: Cases of life-threatening serotonin syndrome have been reported with the concurrent use of tapentadol and serotonergic drugs. Serotonergic drugs comprise Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, drugs that affect the serotonergic neurotransmitter system (e.g. mirtazapine, trazodone, and tramadol), and drugs that impair metabolism of serotonin (including MAOIs). This may occur within the recommended dose. Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) and can be fatal.

Use in Patients with Gastrointestinal Conditions: NUCYNTA® ER is contraindicated in patients with GI obstruction, including paralytic ileus. The tapentadol in NUCYNTA® ER may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Avoidance of Withdrawal: Avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including NUCYNTA® ER. In these patients, mixed agonists/antagonists and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

When discontinuing NUCYNTA® ER, gradually taper the dose.

Driving and Operating Heavy Machinery: NUCYNTA® ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of NUCYNTA® ER and know how they will react to the medication.

Hepatic Impairment: A study with an immediate-release formulation of tapentadol in subjects with hepatic impairment showed higher serum concentrations of tapentadol than in those with normal hepatic function. Avoid use of NUCYNTA® ER in patients with severe hepatic impairment. Reduce the dose of NUCYNTA® ER in patients with moderate hepatic impairment. Closely monitor patients with moderate hepatic impairment for respiratory and central nervous system depression when initiating and titrating NUCYNTA® ER. Renal Impairment: Use of NUCYNTA® ER in patients with severe renal impairment is not recommended due to accumulation of a metabolite formed by glucuronidation of tapentadol. The clinical relevance of the elevated metabolite is not known.

ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.3)] • Interaction with Other CNS Depressants [see Warnings and Precautions (5.4)] • Hypotensive Effects [see Warnings and Precautions (5.7)] • Gastrointestinal Effects [see Warnings and Precautions (5.11)] • Seizures [see Warnings and Precautions (5.9)] • Serotonin Syndrome [see Warnings and Precautions (5.10)] Clinical Trial Experience Commonly-Observed Adverse Reactions in Clinical Studies with NUCYNTA® ER in Patients with Chronic Pain due to Low Back Pain or Osteoarthritis The most common adverse reactions (reported by ≥10 % in any NUCYNTA® ER dose group) were: nausea, constipation, dizziness, headache, and somnolence.

The most common reasons for discontinuation due to adverse reactions in eight Phase 2/3 pooled studies reported by ≥1% in any NUCYNTA® ER dose group for NUCYNTA® ER- and placebo-treated patients were nausea (4 % vs. 1%), dizziness (3% vs. <1%), vomiting (3% vs. <1%), somnolence (2% vs. <1%), constipation (1% vs. <1%), headache (1% vs. <1%), and fatigue (1% vs. <1%), respectively.

Commonly-Observed Adverse Reactions in Clinical Studies with NUCYNTA® ER in Patients with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy The most commonly reported ADRs (incidence ≥ 10% in NUCYNTA® ER-treated subjects) were: nausea, constipation, vomiting, dizziness, somnolence, and headache.

Postmarketing Experience: The following adverse reactions, not above, have been identified during post approval use of tapentadol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Psychiatric disorders: hallucination, suicidal ideation, panic attack.

Anaphylaxis, angioedema, and anaphylactic shock have been reported very rarely with ingredients contained in NUCYNTA® ER. The psychiatric disorders end with panic attack. Advise patients how to recognize such reactions and when to seek medical attention.

DRUG INTERACTIONS Alcohol: Concomitant use of alcohol with NUCYNTA® ER can result in an increase of tapentadol plasma levels and potentially fatal overdose of tapentadol. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol while on NUCYNTA® ER therapy.

Monoamine Oxidase Inhibitors: NUCYNTA® ER is contraindicated in patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have taken them within the last 14 days due to potential additive effects on norepinephrine levels, which may result in adverse cardiovascular events.

CNS Depressants: The concomitant use of NUCYNTA® ER with other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol can increase the risk of respiratory depression, profound sedation, coma and death. Monitor patients receiving CNS depressants and NUCYNTA® ER for signs of respiratory depression, sedation and hypotension.

When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced.

Serotonergic Drugs: There have been post-marketing reports of serotonin syndrome with the concomitant use of tapentadol and serotonergic drugs (e.g., SSRIs and SNRIs). Caution is advised when NUCYNTA® ER is coadministered with other drugs that may affect serotonergic neurotransmitter systems such as SSRIs, SNRIs, MAOIs, and triptans. If concomitant treatment of NUCYNTA® ER with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Muscle Relaxants: Tapentadol may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Monitor patients receiving muscle relaxants and NUCYNTA® ER for signs of respiratory depression that may be greater than otherwise expected.

Mixed Agonist/Antagonist Opioid Analgesics: Mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) and partial agonists (e.g., buprenorphine) may reduce the analgesic effect of NUCYNTA® ER or precipitate withdrawal symptoms. Avoid the use of mixed agonist/ antagonist analgesics in patients receiving NUCYNTA® ER. Anticholinergics: The use of NUCYNTA® ER with anticholinergic products may increase the risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

USE IN SPECIFIC POPULATIONS Pregnancy Clinical Considerations Fetal/neonatal adverse reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly.

Teratogenic Effects - Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. NUCYNTA® ER should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: Opioids cross the placenta and may produce respiratory depression in neonates. NUCYNTA® ER is not for use in women during and immediately prior to labor, when shorter acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. However this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor.

Nursing Mothers: There is insufficient/limited information on the excretion of tapentadol in human or animal breast milk. Physicochemical and available pharmacodynamic/toxicological data on tapentadol point to excretion in breast milk and risk to the breastfeeding child cannot be excluded.

Because of the potential for adverse reactions in nursing infants from NUCYNTA® ER, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Withdrawal symptoms can occur in breast-feeding infants when maternal administration of NUCYNTA® ER is stopped.

Pediatric Use: The safety and efficacy of NUCYNTA® ER in pediatric patients less than 18 years of age have not been established.

Geriatric Use: Of the total number of patients in Phase 2/3 double-blind, multiple-dose clinical studies of NUCYNTA® ER, 28% (1023/3613) were 65 years and over, while 7% (245/3613) were 75 years and over. No overall differences in effectiveness or tolerability were observed between these patients and younger patients.

In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.

Renal Impairment: The safety and effectiveness of NUCYNTA® ER have not been established in patients with severe renal impairment (CLCR <30 mL/min). Use of NUCYNTA® ER in patients with severe renal impairment is not recommended due to accumulation of a metabolite formed by glucuronidation of tapentadol. The clinical relevance of the elevated metabolite is not known.

Hepatic Impairment: Administration of tapentadol resulted in higher exposures and serum levels of tapentadol in subjects with impaired hepatic function compared to subjects with normal hepatic function. The dose of NUCYNTA® ER should be reduced in patients with moderate hepatic impairment (Child-Pugh Score 7 to 9).

Use of NUCYNTA® ER is not recommended in severe hepatic impairment (Child-Pugh Score 10 to 15).

DRUG ABUSE AND DEPENDENCE Controlled Substance: NUCYNTA® ER contains tapentadol, a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. NUCYNTA® ER can be abused and is subject to misuse, addiction, and criminal diversion. The high drug content in the extended release formulation adds to the risk of adverse outcomes from abuse and misuse.

Abuse: All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Drug abuse is the intentional non-therapeutic use of an over-the-counter or prescription drug, even once, for its rewarding psychological or physiological effects. Drug abuse includes, but is not limited to the following examples: the use of a prescription or over-the-counter drug to get “high,” or the use of steroids for performance enhancement and muscle build up.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and include: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.

“Drug-seeking” behavior is very common to addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of loss of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers, and people suffering from untreated addiction. Preoccupation with achieving pain relief can be appropriate behavior in a patient with poor pain control.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.

NUCYNTA® ER, like other opioids, can be diverted for non-medical use into illicit channels of distribution.

Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Dependence: Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, nalmefene, mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.

NUCYNTA® ER should not be abruptly discontinued. If NUCYNTA® ER is abruptly discontinued in a physically-dependent patient, an abstinence syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, increased blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.

OVERDOSAGE Clinical Presentation: Acute overdosage with opioids can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes pulmonary edema, bradycardia, hypotension and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations.

Treatment of Overdose: In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.

Rx Only

© 2015 Depomed, Inc., Newark, CA 94560 USA NUCYNTA® ER is a registered trademark of Depomed, Inc. All rights reserved.APL-NUCX-0041 Rev.2

American Academy of Pain Management

The Pain Practitioner

www.aapainmanage.org ACADEMY BOARD OF DIRECTORS

SPRING 2016, Volume 26, NumbeR 1

President Joanna Katzman, mD, mSPH Past President Robert A. bonakdar, mD, FAAFP Secretary Paul Christo, mD, mbA Treasurer Kevin T. Galloway, bSN, mHA, Colonel, uS Army (Retired) Directors-at-Large Alfred V. Anderson, mD, DC John Garzione, DPT Christian D. GonzĂĄlez, mD Gerald Q. Greenfield, Jr., mD W. Clay Jackson, mD, DipTh michael Kurisu, Do, AbIHm Arthur S. Roberts, DDS, mD Liaison to the Board maggie buckley

Notes from the Field 10

Pain Management Education in Professional Schools

By Robert Twillman, PhD, FAPM, Executive Director

Academy News 12 13

You Should Knowâ&#x20AC;Ś Newly Credentialed Members

ACADEMY STAFF

PAGe 18

PAGe 26

Features 14

Interprofessional Pain Management

18

VA Pain Care Transformation

26

Case Study A Progressive Treatment For a Chronic Progressive Disease: The War Against Complex Regional Pain Syndrome

By Joanna Katzman, MD, MSPH, and Cynthia M.A. Geppert, MD

By Christine Rhodes, MS

By Benjamin Keizer, PhD, Lindsay Sposato, MS, OTR/L, and Kathleen Yancosek, PhD, OTR/L, CHT

From the Clinic 32

Avoiding Electronic Medical Record Pitfalls in Chronic Pain Management

By Brett Snodgrass, APRN, FNP-C

34

How Can I Help a Patient in Pain Who is Fearful of Movement?

Roger Mignosa, DO

Commentary 36

Opioid Prescribing: Dosage Threshold or Ceiling?

By Katie Duensing, JD

Subscribe to The Pain Practitioner!

If you are not a member, you can still get this quarterly publication for just $50/year. Send your check to the American Academy of Pain Management, 975 morning Star Drive, Ste. A, Sonora, CA 95370

8

| T H E PA I N PR AC T ITION ER | S P R I N G 2 016

PAGe 32

Executive Director Robert Twillman, PhD, FAPm Director of Education and Credentialing Debra Nelson-Hogan Director of Sales, Marketing and Events Jillian manley Director of the State Pain Policy Advocacy Network (SPPAN) Amy Goldstein, mSW Accounting Director Kristin Taylor Assistant Director of Education Cathleen Coneghen Researcher and Policy Analyst Katie Duensing, JD Account Managers Rosemary lemay, Staci Criswell, macKenzie Davis and Sheila miller Office Manager Karen Hebert

THE PAIN PRACTITIONER STAFF AND CONSULTANTS Editor-in-Chief Debra Nelson-Hogan Advertising and Sales Jillian manley, Sheila miller Managing Editor Cathleen Coneghen Clinical Editor Christine Rhodes, mS Art Director Amy bothwell Copy Editor Rosemary Hope The Pain Practitioner is published by the American Academy of Pain Management, 975 Morning Star Drive, Ste., A, Sonora, CA 95370, Phone 209-533-9744, Fax 209-533-9750, Email: aapm@ aapainmanage.org, website: www. aapainmanage.org. Copyright 2007 American Academy of Pain Management. All rights reserved. Send correspondance to Debra Nelson-Hogan at dhogan@aapainmanage. org. Contact Sheila Miller at 209-533-9744, or smiller@aapainmanage.org regarding advertising opportunities, media kits, and prices.

The Pain Practitioner is published by the American Academy of Pain Management solely for the purpose of education. All rights are reserved by the Academy to accept, reject, or modify any submission for publication. The opinions stated in the enclosed printed materials are those of the authors and do not necessarily represent the opinions of the Academy or individual members. The Academy does not give guarantees or any other representation that the printed material contained herein is valid, reliable, or accurate. The American Academy of Pain Management does not assume any responsibility for injury arising from any use or misuse of the printed material contained herein.

The printed material contained herein is assumed to be from reliable sources, and there is no implication that they represent the only, or best, methodologies or procedures for the pain condition discussed. It is incumbent upon the reader to verify the accuracy of any diagnosis and drug dosage information contained herein, and to make modifications as new information arises.

All rights are reserved by the Academy to accept, reject, or modify any advertisement submitted for publication. It is the policy of the Academy to not endorse products. Any advertising herein may not be construed as an endorsement, either expresed or implied, of a product or service.

FROM NEUROGENX

Million Dollar Cash Model PROVEN CLINICAL SOLUTION FOR NEUROPATHY COMBINED WITH SUCCESSFUL BUSINESS SYSTEM HELPS DOCTORS CREATE MILLION DOLLAR CASH PRACTICES! Today’s medical professionals need to provide expert care while simultaneously growing and managing a sound medical business. Neurogenx helps you deliver on both counts.

The Neurogenx Solutions Program can transform your business and clinical operations and make yours a million-dollar practice in 12 months – guaranteed!

The Solutions Program provides a unique combination of a proven treatment for neuropathy and a comprehensive cash medical business system.

To help you learn and implement our turnkey system, the program includes a special Jump Start Boot Camp where our team closes $40-50K in 5 Days for you in order to insure your Quick Start to $100K in 30 Days and One Million in 12 months!

The timing is right for a new medical business approach. Currently, neuropathy patients are underserved due to lack of viable treatment options.

Accordingly, there is tremendous practice growth opportunity in offering Neurogenx, a proven treatment with measurable, long-term results. From a medical business perspective, the treatment is effective, the market need exists and the Neurogenx Solutions Program provides an exceptional way to successfully implement medical marketing and cash pay integration.

“Since I added Neurogenx therapies to my practice, I have had phenomenal success in a very short time - $65,000+ in cash in the first week! There is no doubt that you can double or triple your annual revenues using their systematic approach with their neuropathy solutions program. Their turn key methods are simple to implement and extremely effective. When we started, we did not expect the number of patients that we eventually booked!

Trying to see all of the neuropathy patients is now my biggest problem!”

- Kevin F. Sunshein, DPM, Neurogenx NerveCenter of Centerville, Ohio

Proven Technology “Extremely effective . . . markedly improves pain and quality of life without the side effects of drugs.”

- Richard Jacoby, DPM Scottsdale, Arizona “It’s giving many of our patients a great amount of relief from their neuropathy symptoms, including numbness and pain.”

- Darren Silvester, DPM Pleasanton, Texas “Very effective, a critical cornerstone in treatment.”

- Steve Barrett, DPM Phoenix, Arizona *87% reduction in symptoms is based on an April 2012 published medical study. Offices following these protocols have seen similar results. Individual results may be the same or different depending on your patient’s age, condition, treatment compliance, genetics, diagnosis and other factors. **Results may vary depending on size of patient population & market analysis as well as your ability to follow our Solutions Program.

Proven Business Solution Over $100,000 CASH in the First 30 Days!

“Between the resources provided by the Neurogenx marketing support team and their in-office training, I was able to have a brandnew medical center up and running in about 30 days and have the center profitable within its first month. The most rewarding part is that our patients have been able to enjoy results that have been literally life-changing.”

- Dr. Michael Begley, President and Executive Director, NeurogenxNerveCenter of Brentwood, Tennessee

Over 200 New Patients in First 4 Months!

“The Neurogenx team prepared me, trained me and showed me everything I needed to know about opening a successful startup medical facility. I love this business model and treatment. I’m excited for 2016!”

- Paul Todd, Executive Director, Neurogenx NerveCenter of Hoover, Alabama

Revenue exceeded $70,000 in CASH in First 3 Weeks!

“The Neurogenx Solutions Program is the total package. We anticipate opening a second NerveCenter within the next 6 months – with regards to the Neurogenx Program, I think that speaks for itself.”

- Thomas Stetler, President and Executive Director, Neurogenx NerveCenter of St. Petersburg, Florida

Proven Clinical Solution “I’m 61 years old and my diabetic neuropathy made my toes feel as if the skin had been sanded off with 80-grit sandpaper. During my 3rd Neurogenx treatment the muscles in my legs started tensing, flexing and moving - they came back to life! For the first time in years I could actually feel the rug under my feet!” (Todd W.) “Before I came to Neurogenx, my feet were swollen badly and I was in lots of pain. I had been suffering with neuropathy since the 1990s. It had gotten so bad that I couldn’t walk. Now the pain and swelling is all gone.” ( H. Lann) “I’ve had neuropathy for 25 years, and after the first treatment I was able to move my feet and roll my toes in ways that I couldn’t since I was 40 years old. I’m grateful for this!” ( W. Owen) Learn more about becoming Neurogenx Provider or a NerveCenter at www.neurogenx.com/million-dollar-model/ or call 1-800-335-7624 to secure your geographical area now.

• We help you learn step-by-step with our Proven TURNKEY Clinical and Business Solutions Program!

• Jump Start Boot Camp where our team closes & collects $40-50K in 4 to 5 days for you!

• Quick Start Program coaches you to close and collect $100K in 30 Days and $1 Million in 12 months!

NOTES FROM THE FIELD

Pain Management Education in Professional Schools

BY ROBERT T WILL M AN, PHD, FAPM, E XECU TI V E DIREC TOR

R

ecently, I stumbled across a news article reporting that some medical schools are starting to increase their offerings related to pain management. The article described programs at several schools, all of which have instituted new requirements for students to complete coursework about how to manage pain. That is a big piece of really good news, and it caused me to think a bit about how we can further improve pain management education in all health care professional training programs.

The 2011 Institute of Medicine report, Relieving Pain in America, found that, in the course of a four-year medical education, the median amount of class time spent on pain management was nine hours. Nine hours may sound like a fair amount, but contrast that to the educational content on pain for veterinary students: 75 hours! It’s truly a sad situation when our pets see better-educated providers than we do.

Data on content in nursing and allied health programs are scant and dated, but all indications are that they don’t fare much better. How can we legitimately expect clinicians to provide top-quality pain care if they don’t learn how to do so in their training programs?

Unfortunately, in comparison to educational content on substance abuse, pain management education is abundant.

A survey of member programs by the Association of American Medical Colleges during academic year 20132014 found that fully one-third had no coverage of substance abuse in their curricula. Further, for those that did cover the topic, the median number of “teaching events” was only five.

Maybe it’s not such a mystery how we got to where we are today, with two enormous public health problems that are killing thousands of people each year and impairing

In the course of a four-year medical education, the median amount of class time spent on pain management was nine hours.

10

| T H E PA I N PR ACTITION ER | S P R I N G 2 016

quality of life for millions.

It is much easier to identify the need and even to suggest solutions than it is to bring those solutions into being, but nonetheless, let me offer some suggestions. First, because pain management really is a “team sport,” we need to be providing the same education to all team members. The recent trend toward interprofessional education, where medical, nursing, pharmacy, and allied health students all work together as teams in the learning environment, seems absolutely essential. Training programs need to establish these learning teams and provide them with adequate opportunities for learning about both pain management and substance use disorders. I’m not prepared to say how much is adequate, but I think everyone agrees that it is a lot more than nine hours.

In addition to the existing model for interprofessional education, what if we broadened the scope just a bit for pain management education by including other licensed or certified providers, such as chiropractors, acupuncturists, massage therapists, etc.? If we want clinicians to use a wide variety of interventions in lieu of opioid monotherapy, we need to teach them about those interventions, and how better to do that than by fostering broadly interprofessional team learning? Bringing integrative health care providers into medical schools might shake the foundations, but maybe those foundations need to be shaken.

Finally, what about ensuring that all students have the opportunity to hear from people who live with chronic pain and substance use disorders, as well as some of their care-givers? I know of several programs that are allowing people with pain to teach medical students, and I hear that the impact can be profound. Why not expand the availability of these opportunities, ensuring that students hear about both problems, and that they hear about them from caregivers who have to witness the suffering, as well?

There’s a lot to be done, but I think we know what we need to be doing. So, let’s get busy doing it!

THE 27TH ANNUAL MEETING San Antonio, Texas SEPTEMBER 22-25, 2016

J W M A R R I O T T H I L L C O U N T RY

Join clinicians from a wide variety of disciplines, to exchange ideas and expand your knowledge!

This meeting is for all clinicians interested in learning about an integrative approach to pain management.

REGISTER NOW at aapainmanage.org or call (209) 533-9744

MAKE YOUR PLANS FOR 2016!

Register early for reduced pricing.

@aapainmanage #NoLifeLimitedByPain facebook/aapainmanage

5 REASONS TO ATTEND...

1. Learn about the best practices in integrative pain management.

2. Participate in handson and experiential sessions.

3. Connect with thought leaders, researchers, and like-minded clinicians.

4. Get updates on new technologies and techniques in pain management.

5. Find out about state and federal policies that may affect your practice.

ACADEMY NE WS + RESOURCES

You Should Know...

Our NEW Pain Care Learning Center is Off and Running the Academy’s Pain Care Learning Center (PCLC), launched the first week of January, is attracting a variety of clinicians who want to take advantage of ondemand, pain-focused continuing education. Presently, there are 25 educational activities housed in the PCLC, and every twomonths at least two new activities will be added. Programs are accredited for physicians, nurses, and psychologists and other members can submit a certificate of attendance to receive the appropriate credit.

PCLC is different from other online educational centers because of the variety of programs and the participants

enrolling. the education offered is appropriate for all practitioners who work with patients in pain. In addition to physicians, nurse practitioners, nurses, and psychologists, our current enrollments have included physical therapists, naturopathic physicians, dentists, and acupuncturists.

One nurse wrote to us that she really enjoyed the different types of pain-focused programs available. Our unique selection of integrated pain courses is really what makes us stand out from the rest. the Academy believes that education is at the center of quality patient care, and offers these programs free to our members. Non-members can also access the programs for a nominal fee.

If yOu hAvEN’t tAkEN A PROgRAm yEt, PLEAsE vIsIt us ONLINE At: EduCAtION.AAPAINmANAgE.ORg/

The State Pain Policy Advocacy Network (SPPAN): Improve Access to Integrated Pain Care wE’vE bEEN wORkINg ALONgsIdE NumEROus PARtNERs ON OuR NO. 1 POLICy PRIORIty: ACCEss tO, ANd REImbuRsEmENt fOR, INtEgRAtIvE PAIN CARE.

SPPAN’s stakeholders report that their number one policy priority is ensuring access to, and adequate insurance coverage for, evidencesupported nonpharmacological pain treatments.

Improved access to integrated pain care will bring positive outcomes, such as a better quality of life for patients and a decreased dependence on medications for pain. Current barriers to accessing integrated care include lack of reimbursement, misperceptions about how pain should be treated, inadequacy of referral networks, and lack of an evidence base confirming the health benefits and cost savings of integrative pain care.

SPPAN is actively collaborating with other organizations to address this enormous patient care challenge. Our policy activities for 2016 center around these key objectives: • Advocating for provider nondiscrimination • Capturing cost/benefit data • Shaping federal policy

12

| T H E PA I N PR ACTITION ER | S P R I N G 2 016

• Tracking/monitoring legislation and regulations • Increasing momentum collectively There are many short- and longterm policy goals that could be considered. In 2015, we started to see some positive results, as both Rhode Island and Oregon passed legislation aimed at increasing access to high quality and affordable

health care by prohibiting insurers from discriminating against licensed health care providers acting within their scope of practice, entitling a long list of health care providers to reimbursement for their services.

Other states, including Colorado, Pennsylvania, and Arizona, took steps to broaden access to integrative care by expanding access to, and affordability of, treatments such as acupuncture, massage, physical therapy, chiropractic, and orthotics.

Already this year, we are tracking and analyzing dozens of related bills.

Contact Amy Goldstein, SPPAN Director, at agoldstein@aapainmanage.org if you are interested in talking more about activities in your state. Visit sppan.aapainmanage. org regularly for updates on policy issues and to find more specific details about opportunities for action related to the above activities. vIsIt us ONLINE At sPPAN.AAPAINmANAgE.ORg, OR CONtACt Amy gOLdstEIN, sPPAN dIRECtOR, At AgOLdstEIN@AAPAINmANAgE.ORg. ACupunCTure TrAInIng model

ACADEMY NE WS + RESOURCES

Newly Credentialed Members Academy Contributors Donations support the vital work of the Academy’s policy and advocacy efforts. We would like to thank the following contributors: Arthur E. JordAn, Md Chris J. GrAMMAr, Md dAvid W. nAdlEr, dC EdWArd suArEz, Md JACk M. BErGEr, Md, Phd JAnEt MCniEl, Md JiMMy W. AdAMs, do JoAn riEMEr-ElsEr, oMd JosEPh FrEd stonEr, Md lEssliE G. MoorE, dds, dn, Phd MArtin J. GouloozE, dC MElvin dEl rosArio GonzAGA, Md MErvAt s. Eid, Md

In Memory sAEid AlEMo, Md doMiniCk C. AdornAto, Md CAthErinE A. Purdy, dPM

oBi C. ChinAkWE, dC, Md PAtriCk noonAn, Phd ronAld h. BrAdlEy, do, Phd ruBy h. PAlMEr on BEhAlF oF MiChAEl PAlMEr stEvEn M. rosEnBErG, Phd vErnon d. hollEMAn, Md donations may be tax deductible as an ordinary business expense. if you would like to donate in support of our policy and advocacy please contact the Academy at 209-533-9744 or aapainmanage.org.

Open to all pain practitioners, the Academy’s Credential demonstrates that a clinician is knowledgeable about interdisciplinary/integrative pain management; has practiced in the field of pain management for at least two years; remains in good standing with federal and state regulatory agencies; has passed a rigorous exam; and is committed to ongoing education in the field of pain. The Academy welcomes the following credentialed pain practitioners who have met the Academy’s requirements and demonstrated proficiency in the management of pain.

AdvAnced credenTiAled pAin prAcTiTioner (Acpp) AdvAnced diplomATe

We honor the memory of the following deceased members: GlAdstonE P. GuruBAthAM, Phd Gil dEl CAstillo, Md PAndu tAdoori, Md

T h i s w e e K i n pA i n

carl john bonnett, md, (left) is an emergency physician in san Antonio, texas. he is the founder and Medical director of klarisana. danny silver, md, (center) is the Medical director at oxygens, inc. in Fort smith, Arkansas. leigh Anne young, md, (right) has 26 years’ experience in the practice of internal medicine. she presently works at simpson Clinic, llC. in kingsport tennessee, providing urgent, primary, and chronic pain care. she is also the director of the new postoperative pain center at simpson Clinic, llC, which uses genetic testing and presurgery counseling to improve pain control after surgery.

GenerAl credenTiAled pAin prAcTiTioner (Gcpp) diplomATe

aapainmanage.org/category/news/

AcAdemy StAtement on co-PreScribing of nAloxone in conjunction with oPioid therAPy The Academy recently published guiding principles for clinicians who prescribe opioid therapy for their patients.

Given the widespread concerns about the risks of longterm opioid therapy, it is prudent for prescribers to assess their patients receiving opioid therapy for factors that increase risk of clinically significant respiratory depression, and to provide appropriate education for those patients about those factors.

To reAd The sTATemenT, pleAse visiT The AcAdemy websiTe AT bloG.AApAinmAnAGe.orG/co-prescribinG-of-nAloxone-inconjuncTion-wiTh-opioid-TherApy/

darren ezer, md, mbA, ccfp, frcpc, (left) holds a staff position in Anesthesiology at the William osler health Centre in toronto, Canada. muthukumar venkatachalam, mbbs, ms, (center) is director of Masterhealth hypnosis in houston, texas, and has been involved in integrative medicine since 1989.

Adel mohamed Gamal eldin shaaban, md, (right) currently works at king hamad university hospital, kingdom of Bahrain in the Anesthesia and Pain Management department. fellow daniel william martin, oTr/l, fAApm, fAsseT, cmTpT/cdn, is lead therapist of Baltimore orthopaedics and rehabilitation in Baltimore, Maryland.

for more informATion, visiT www.AApAinmAnAGe.orG/ credenTiAlinG/, cAll 209-288-2205, or emAil credenTiAlinG@AApAinmAnAGe.orG.

THE PAIN PRACTITIONE R

| VOLUME 26, NUMBER 1 |

13

interprofessional pain management the importance of collaboration

b

By Joanna G. K atzman, mD, mSPH, anD CyntHia m.a. GePPert, mD, PHD, mPH

oth interdisciplinary and integrative approaches in chronic pain management are now considered best practices (1). Interdisciplinary pain care involves several specialists examining and/or discussing individual patients in a comprehensive team-based approach. Integrative care includes alternative and complementary approaches to augment traditional medical care. These approaches are now recognized worldwide as effective treatments for many types of pain (2-4). Unfortunately, the current state of medical education and health care delivery present a number of barriers that must be overcome to make this ideal a reality.

14

| T H E PA I N PR ACTITION ER | S P R I N G 2 0 1 6

One of the most significant barriers is the lack of adequate training in pain management in health professional schools. It is neither just nor feasible to expect clinicians to provide their patients with best practices in pain management when they have never themselves received sufficient training in those practices (5,6). Unfortunately, limited access to both training and specialty consultation often leaves primary care physicians on the frontline in caring for many patients with intractable chronic pain. PCPs practicing in rural areas and small communities are especially isolated due to a disproportionate lack of pain specialists in these regions.

Fortunately, a cultural shift has begun to take place

in terprofessional pain m anagemen t

in many academic institutions with the recognition that interprofessional education (IPE) and collaborative practice approaches to integrative pain management are essential for delivering quality patient care. Since the Institute of Medicine published two reports on the importance of interprofessional-interdisciplinary collaboration in the implementation of team-based patient-centered care around 15 years ago, IPE has rapidly gained acceptance as the consummate educational format in many academic health sciences centers worldwide (7,8). The World Health Organization defines IPE as “when students from two or more professions learn about, from, and with each other to enable effective collaboration and improve outcomes” (9).

An example of IPE in a traditional classroom setting would be a lecture on musculoskeletal pain delivered to a diverse group of students from the nursing, pharmacy, medicine, and physical therapy programs in their undergraduate training. Clinical case conferences are another teaching method frequently used in IPE to demonstrate the interrelatedness of the various health care professions and to help students appreciate the specific clinical contributions of each discipline. An IPE clinical rotation may include one or two students from each of the aforementioned disciplines working together in an outpatient clinic or hospital ward to provide coordinated care for a group of patients. Studies examining adult learning successes from undergraduate health professional students suggest that these interdisciplinary forms of instruction have satisfaction scores similar to or higher than uniprofessional course work.

Collaborative Practice

Effective interprofessional education (IPE) promotes successful collaborative practice (10). The interprofessional collaborative practice model allows a diverse group of health care professionals with unique knowledge and skills to function as a team with the patient at the center of the team (9). Teambased care has been practiced successfully for decades in interdisciplinary pain management programs, and hospitalbased integrative care teams that also offer complementary and alternative services are now considered the standard of care for some hospital systems (11,12). Many peer-reviewed studies, including meta-analyses, suggest improved quality of care, more appropriate health care utilization, and decreased lengths of hospital stays when collaborative practice teams are present (10,13). Each health care professional is an equal member of the team who brings added value and plays a vital role in the treatment plan for each patient (9).

Because of the global shortage of physicians, it is recognized that a patient-centered team of care, rather than

a clinician-focused team is vital to the quality of health in many countries, according to the World Health Organization in 2010 (9). In 2011, a panel of experts developed a consensus report on four core competencies for interprofessional collaborative practice (14). As noted in Table 1, the competencies are values and ethics, roles and responsibilities, interprofessional communication, and teams and teamwork.

Shared professional values and trans- and cross-profession ethical relationships are the first core competency for interprofessional collaborative practice. Patient confidentiality in team-based care, for example, has important considerations different from those of single professions. For instance, if a patient communicates potentially stigmatizing information, such as illicit drug use to one member of the team and requests this not be shared with the rest of the team, how is this dilemma best handled to protect patient privacy but ensure all team members are aware of clinically important health information?

The second interprofessional core competency is development of a respectful understanding of the value of one’s own professional role and responsibilities as well as the roles and responsibilities of the other team members in relation to one’s own. Mastery of this competency is vital to the effective functioning of the collaborative practice in order to prevent “disparity diversity,” or stereotyping; improve communication; foster mutual respect; and ultimately optimize health outcomes.

Communication among a diverse group of professions is the third core competency. It is crucial that no cultural hierarchy exists within the team-based practice. For many professions, such as nurses, doctors, dentists, physical therapists, chiropractors, and massage therapists, there are preconceived Table 1.

Four Core Competencies for Interprofessional Collaborative Practice Values and Ethics

–Mutual respect and trust among colleagues –Patient centeredness –Shared purpose

Roles and Responsibilities

–Understanding and respecting the diversity of expertise among a diverse team of interprofessionals –Need for shared goals and collaboration

Interprofessional Communication

–Common language –Active listening –Instructive feedback

Teams and Teamwork

–Understanding the valuable contribution of all team members –Staying focused on patient-centered goals, rather than previously determined hierarchical structures

THE PA IN PRACTITIONE R

| VOLUME 26, NUMBER 1 |

15

in t erprofessional pain m anagemen t

social differences, such as the physician as the “captain of the ship” mentality. A collaborative practice team is a “community of equals” in which differences of opinion and divergent perspectives are discussed among team members. Mutual respect and communication are essential to the success of the teambased care and are the hallmark of interprofessional practice.

The final core competency is effective teamwork. Many professionals are used to working in the clinical silos of the single profession, and when brought together with a diverse group of experts collaborating for the benefit of one patient’s care, it can be challenging to stay focused on the patient’s goals and avoid older hierarchical styles. Learning to remain patient centered and to embrace shared decision-making as a source of clinical strength can help with the transition to a collaborative practice model of care.

The Team

For best practice pain management, a diverse group of pain specialists form an interdisciplinary, multidimensional, and multimodal team (1). Specialists usually include physicians with fellowship training in pain management (neurology, physical medicine and rehabilitation, anesthesia, psychiatry); primary-care pain champions with added training in pain management; mental health clinicians with experience in pain and addiction; pain management nursing; physical and

occupational rehabilitation; chiropractic medicine specialists; acupuncture; myofascial therapy; and clinical pharmacy. The challenge to creating a team incorporating these members includes shortage of many of the specialties, financial limitations, recruitment, and retention. The clinicians, staff, and patients of such an integrative and collaborative practice are highly satisfied, however, with the interdisciplinary nature of the team model (15).

Echo Pain: Example of Interprofessional Education and Collaborative Practice

An innovative and widely imitated program of integrative and interdisciplinary pain management that exemplifies the collaborative model of practice and interprofessional education is the Project ECHO Chronic Pain and Headache Management Clinic (ECHO Pain). ECHO Pain enables any primary care provider with telehealth capability to obtain clinical consultation and real-time training from pain experts in multiple disciplines. Developed in 2009 to address limitations in access to pain care throughout New Mexico and the United States, ECHO Pain has four unique aspects characterized by the utilization of tele-technology, adhering to best practices to reduce variation in care, connecting community clinicians with specialists for case-based learning and formal didactics, and tracking data to monitor outcomes (see Table 2).

Thank you to our Corporate Council Members!

Find your state’s Policy Page on sPPan’s website

sppan.aapainmanage.org 16

| T H E PA I N P R AC T I T I O N E R | S P R I N G 2 0 1 6

Become a Corporate Council Member today!

Contact sheila Miller at smiller@aapainmanage.org) or Jillian Manley at jmanley@aapainmanage.org, (209) 533-9744

in terprofessional pain m anagemen t

Table 2.

BesT PracTices for inTegraTive Pain ManageMenT in a coMMuniTy exTension Model 1. use all necessary modalities (multipoint videoconferencing and internet) to leverage scarce health care resources.

2. disease management model focused in improving outcomes by reducing variation in processes of care and sharing best practices.

3. case-based learning: attendee presentation of actual patients to interprofessional team of specialists.

4. HiPaa compliant web-based database to monitor outcomes.

Adapted from Arora S, Geppert CM, Kalishman S, et al.

Academic health center management of chronic diseases through knowledge networks: Project ECHO. Acad Med. 2007;82(2):154-160.

AAPM establishes special interest group to unify interdisciPlinAry cAre Last September at the American Academy of Pain Management Annual Clinical Meeting, a new special interest group of integrative practitioners met with a common purpose to improve the medical approach to pain management by unifying interdisciplinary care.

During the meeting, they established the goal of instilling a culture of medicine that nurtures a comprehensive evaluation and treatment

ECHO Pain allows a diverse group of health care professionals to present real, de-identified cases, to receive structured didactics specific to pain and addiction, and to obtain no-cost continuing medical education credit. The team provides a consultation over the network and electronically sends suggestions to the presenting clinician in a Health Insurance Portability and Accountability Act (HIPAA)-compliant manner. The program has shown significant clinician improvements in knowledge, self-efficacy, and attitudes when caring for patients with chronic pain (16).

Many other organizations have replicated ECHO Pain and other ECHO programs throughout the country.

These have included academic medical centers, such as the University of Washington, the University of Chicago, the Veterans Affairs-SCAN-ECHO, The Armyâ&#x20AC;&#x2122;s Department of Defense, the Indian Health Service, and the Canadian Health Ministry. It is hoped that practitioners who, in a spirit of collaboration, utilize complementary and alternative approaches within the framework of interdisciplinary, interprofessional integrative pain management will be in a better position to appreciate and ameliorate the many faces of pain.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

of pain with interdisciplinary teamwork that addresses the physical, emotional, and spiritual roots of health.

The group will be guided by a roadmap of actions intended to foster cultural change toward sustainable health care. First, all agreed that interdisciplinary education was the most important path to best practices pain management. Next are efforts aimed at empowering the culture to understand

and create the expectation for receiving comprehensive care through education and modeling activities.

Efforts to be developed by the Academy include standardizing clinical roles, increasing avenues for communication between practitioners and between the Academy and its partners, and developing a model of interdisciplinary pain education for the pain field.

complementary and alternative therapies among clinical nurse specialists in an academic medical center. Clin Nurse Spec. 2010;24(3):125-131.

Mezei L, Murinson BB, the Johns Hopkins Pain Curriculum Development Team.

Pain education in North American medical schools. J Pain. 2011;12(12):1199-1208.

Fishman SF, Young HM, Arwood EL, et al. Core competencies for pain management: results of an interprofessional consensus summit. Pain Med. 2013;14(7):971-981.

Courtneay M, Bair A, Bakerjian D, et al. Interprofessional education: an overview of six initiatives across the schools of health at a single university. J Interprof Care.

2013;28(2):155-156.

Kitts RL, Christodoulou J, Goldman S. Promoting interdisciplinary collaboration: trainees addressing siloed medical education. Acad Psychiatry. 2011;35(5):317-321.

World Health Organization. Framework for Action on Interprofessional Education and Collaborative Practice. Geneva: WHO; 2010.

Thistlethwaite J. Interprofessional education: a review of context, learning and the research agenda. Med Educ. 2012;46(1):58-70.

Flor H, Fydrich T, Turk DC. Efficacy of multidisciplinary centers; a meta-analytic review. Pain. 1992;49(2);221-230.

Knutson L, Johnson PJ, Sidebottom A, Fyfe-Johnson A. Development of a hospital-based integrative healthcare program. J Nurs Adm. 2013;43(2):101-107.

Schmitt M. Collaboration improves the quality of care: methodological challenges and evidence from US health care research. J Interprof Care. 2001;15(1):47-66.

Interprofessional Education Collaborative Expert Panel. Core competencies for interprofessional collaborative practice: Report of an expert panel. Washington, D.C.: Interprofessional Education Collaborative; 2011. http://www.aacn.nche.edu/ education-resources/ipecreport.pdf. Accessed February 8, 2016.

Pechak C, Gonzalez E, Summers C, Capshaw S. Interprofessional education: a pilot study of rehabilitation sciences students participating in interdisciplinary international service-learning. J Allied Health. 2013;42(3):e61-e66.

Katzman J, Comerci G, Boyle J, et al. Innovative telementoring for pain management: project ECHO pain. J Contin Educ Health Prof. 2014;34(1):68-75.

This article was excerpted from Geppert CMA, Katzman JG. Integrative case management: the importance of collaboration and the Project ECHO example. In: Integrative Pain Management, Edited by Robert A. Bonakdar and Andrew W. Sukiennik; Weil Integrative Medicine Library, Oxford University Press; New York, NY; 2016:579-592. references 1.

2.

3.

4.

Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington DC: The National Academic Press; 2011.

Malone MA, Gloyer K. Complementary and alternative treatments in sports medicine. Prim Care. 2013;40(4):945-968.

Cotton S, Luberto CM, Bogenschutz LH, Pelley TJ, Dusek J. Integrative care therapies and pain in hospitalized children and adolescents: a retrospective database review. J Altern Complement Med. 2014;20(2):98-102.

Cutshall S, Derscheid D, Miers AG, et al. Knowledge, attitudes, and use of

Joanna g. Katzman, Md, MsPH, (left) is president of the American Academy of Pain Management, Director of the University of New Mexico Pain Center and Co-Director of the University of New Mexico Project ECHO Chronic Pain Program. cynthia M.a. geppert, Md, Phd, MPH, (right) is chief of Consultation

Psychiatry and Ethics at the New Mexico Veterans Affairs Care System, and is professor in the Department of Psychiatry and director of Ethics Education at the University of New Mexico School of Medicine.

THE PA IN PRACTITIONE R

| VOLUME 26, NUMBER 1 |

17

VA Pain Care Transformation

BY CHris t ine rHoDes, ms

this article was developed from a presentation at the 26th Annual Clinical Meeting of the American Academy of Pain Management. the presenters were: lucile Burgo-Black, Md, facP, general internist and primary care provider with the vA Connecticut, and assistant clinical professor, yale university, new haven, Connecticut. stephen c. Hunt, Md, MPH, staff physician, primary and specialty medical care, vA Puget sound health Care system; national director, vA Post-deployment integrated Care initiative; and clinical associate professor of medicine, university of Washington, seattle, Washington.

Michael saenger, Md, facP, physician lead, Pain Management, veterans Affairs southeast network; director, Empower veterans Program, Atlanta vA Medical Center; and leader, task Force for opioid safety.

W

hen a person comes back from war, his or her life has been changed in every way imaginable, and this generally includes having pain. When we talk about pain care, we are talking about an individual’s life. We are not treating pain; we are providing support and care for an individual who has many things going on in his or her life. How do we put the pieces of pain care together in our setting?

Pain care in the US Department of Veterans Affairs (VA) is very similar to post-deployment care. The VA and the US

Pain is among the most costly disorders treated in the VA, and 90% of chronic pain patients will be managed in primary care.

Department of Defense (DoD) are collaborating on several joint projects to transform pain care in the two organizations and ensure safer pain care for those individuals who are transferring their care from one organization to another.

“We’ve created a change in attitude from ‘We don’t have that’ to ‘How can we bring the pieces together in each individual setting to help the patient?’” said Stephen C. Hunt, MD. “What are the pieces of good pain care?”

The VA and the DoD are partnering to ensure that every pain care center implements six essential elements of good pain care (See Table 1). These include steps that individuals and their families can take to promote self-care; procedures to standardize care and increase team-based care; as well as tools for measuring outcomes. If you have all these pieces in your setting, you have good pain care.

In our recent conflicts alone 2.7 million military personnel have been deployed, half of them more than once. Of these, 1.9 million have left the military and are eligible for VA care. Fifty-three percent of these have been seen in the VA health system since 2002. Pain is among the most costly disorders treated in the VA, and 90% of chronic pain patients will be managed in primary care. Musculoskeletal injuries with pain account for nearly 60% of office visits; depression with posttraumatic stress disorder (PTSD) and other mental health conditions, and nonspecific signs and symptoms, including fatigue, cognitive disturbances, and lowered pain threshold running close behind.

Half of male veterans report chronic pain, and for female veterans it may as high as 75%. Pain, PTSD, and traumatic brain injury (TBI) occur simultaneously in 42% of veterans (1).

In the VA, pain is treated interprofessionally, incorporating medical and mental health care, social work, physical medicine, and other treatment modalities in a stepped-care approach.

Patients are initially taught self-care techniques and receive baseline biopsychosocial care from a primary care-based team, which includes coaching and behavioral management. If patients are refractory to treatment, they proceed to a secondary consultation and care from a multidisciplinary pain medicine specialty team. With multiple comorbidities and increased risk for drug misuse, patients advance to tertiary care in

VA PAin C Are Tr Ansform AT ion

Table 1.

THe Six eSSenTiAl eleMenTS of Good PAin CAre 1. educate veterans and their families to promote selfefficacy and shared decision-making. Provide access to all relevant resources.

2. educate/train all team members to the discipline-specific competencies, including team-based care.

3. develop and integrate nonpharmacological modalities into care plans, including behavioral medicine and integrative medicine techniques.

4. institute rational medicine prescribing, use of pain procedures, and safe opioid use (universal precautions).

5. implement approaches for bringing the veteran’s whole team together, such as virtual pain consulting, and for maintaining ongoing communication between team members.

6. establish metrics to monitor pain care and outcomes at both the individual level and the population level.

an interdisciplinary pain center.

Integrated collaborative care for chronic pain has been studied in the primary care setting, including VA clinics, and has been found to be beneficial. In one study, 401 pain patients were randomized to receive either supplementary pain care (including clinician education, patient assessment and education, symptom monitoring, feedback, and specialty care) or their usual care. After 12 months, there were significant improvements in a variety of outcome measures among the patients receiving collaborative care (2). In another study of 250 patients, those who received 12 weeks of antidepressant therapy along with a self-management program and ongoing therapy had substantial reductions in depression as well as moderate improvements in pain severity and disability (3).

Several initiatives have been developed in the VA and DoD to help build an environment of collaborative, interprofessional integrative care. The DoD/VA Joint Pain Education Project (JPEP) involves creation of a curriculum that will help standardize pain care across the agencies. Another initiative is the training of VA and DoD primary care providers in battlefield, or auricular, acupuncture as a way to help reduce the over-reliance on medications and their resulting adverse effects.

PACTs Provide a Pain Care Model

The VA serves 9.1 million enrolled veterans in a system of 1,900 points of care. The model for care is patient-aligned care teams (PACTs) providing patient-driven, proactive, personalized, team-based care oriented toward wellness and disease prevention. About 50% of care is given in partnership with the community.

The VA is moving from a hospital system to a whole

health system that utilizes comprehensive, integrated holistic pain management.

“We are working hard to improve access to care,” said Lucile Burgo-Black, MD. “This includes funding for local providers to care for veterans when they can’t get into a VA hospital.” A big issue is reaching the approximately 45% of veterans who live in rural settings. “We’ve been moving from the reactive, find it/fix it disease care mentality to a proactive, personalized system using strategies that strengthen a person’s innate capacity for health and healing,” she said. Care is driven by what really matters to the person and is aligned with their health care goals, with selfmanagement being the cornerstone.

Several tools have helped the VA strengthen its ability to provide collaborative, integrated pain care, including: • VA SCAN—A CME program that provides specialty care guidance to the primary care physician. This allows patients to become partners in their care and continue their care with their local primary care provider, while also having access to tertiary care.

• Increased broadband access to community-based clinics through the use of telehealth programs, crisis helplines, and eConsults.

• Opioid Safety Initiative (OSI)—A program that gives providers data on opioid and benzodiazepine use at their facilities with guidance on managing complex pain patients on high-risk medication combinations. System-wide goals include decreasing high-risk opioid prescribing practices and increasing use of opioid risk management tools such as urine drug testing at all VA facilities.

• IMED Consent Directive—This program hardwires the essentials of safe opioid prescribing into the system by mandating informed signature consent following patient and family education for anyone on chronic opioids.

Wheel of Health

According to Michael Saenger, MD, chronic pain is a whole life dysfunction that requires us to reframe our care from a biomedical model to a biopsychosocial/spiritual model and to move patients toward a collaborative, self-management model. Thus, the primary goal for the health care team is not to provide complete pain relief, but rather to reduce suffering and disability, and enhance adaptive choices to enjoy the best life possible. “Rather than assessing pain on a scale from 1 to 10,” said Dr. Saenger, “we ask our patients, ‘What is important to you as an individual? What are your aspirations and dreams? What do you want your health for?’ ” The Wheel of Health, which includes eight self-care Continued on page 24

THE PAIN PRACTITIONE R

| VOLUME 26, NUMBER 1 |

19

Butrans â&#x20AC;&#x201D; 7 Days of Buprenorphine Delivery

Butrans is a Schedule III extended-release opioid analgesic WARNING: ADDICTION, ABUSE and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; and NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse Butrans exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Assess each patientâ&#x20AC;&#x2122;s risk prior to prescribing Butrans, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1) and Overdosage (10)].

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Butrans. Monitor for respiratory depression, especially during initiation of Butrans or following a dose increase. Misuse or abuse of Butrans by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.2)].

Accidental Exposure Accidental exposure to even one dose of Butrans, especially by children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome Prolonged use of Butrans during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

Parentheses refer to sections in the Full Prescribing Information.

Butrans® (buprenorphine) Transdermal System is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use: Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risk of overdose and death with extended-release opioid formulations, reserve Butrans for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Butrans is not indicated as an as-needed (prn) analgesic.

CONTRAINDICATIONS ■

Butrans is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected paralytic ileus; hypersensitivity (eg, anaphylaxis) to buprenorphine

WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse ■ Butrans contains buprenorphine, a Schedule III controlled substance. Butrans exposes users to the risks of opioid addiction, abuse, and misuse.

As modified-release products such as Butrans deliver the opioid over an extended period of time, there is a greater risk for overdose and death, due to the larger amount of buprenorphine present. Addiction can occur at recommended doses and if the drug is misused or abused.

Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing Butrans, and monitor all patients during therapy for the development of these behaviors or conditions.

Abuse or misuse of Butrans by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose and death Life-Threatening Respiratory Depression ■ Serious, life-threatening, or fatal respiratory depression has been reported with modifiedrelease opioids, even when used as recommended, and if not immediately recognized and treated, may lead to respiratory arrest and death. The risk of respiratory depression is greatest during the initiation of therapy or following a dose increase; therefore, closely monitor patients for respiratory depression.

Proper dosing and titration of Butrans are essential. Overestimating the Butrans dose when converting patients from another opioid product can result in fatal overdose with the first dose.

Accidental exposure to Butrans, especially in children, can result in respiratory depression and death due to an overdose of buprenorphine

Neonatal Opioid Withdrawal Syndrome ■ Prolonged use of Butrans during pregnancy can result in neonatal opioid withdrawal syndrome which may be life-threatening to the neonate if not recognized and treated, and requires management according to protocols developed by neonatology experts Interactions with Central Nervous System Depressants ■ Hypotension, profound sedation, coma, respiratory depression, or death may result if Butrans is used concomitantly with other CNS depressants, including alcohol or illicit drugs that can cause CNS depression. Start with Butrans 5 mcg/hour patch, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant Use in Elderly, Cachectic, and Debilitated Patients and Patients with Chronic Pulmonary Disease ■ Closely monitor elderly, cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease because of the increased risk of life-threatening respiratory depression.

Consider the use of alternative non-opioid analgesics in patients with chronic obstructive pulmonary disease if possible QTc Prolongation ■ Avoid in patients with Long QT Syndrome, family history of Long QT Syndrome, or those taking Class IA or Class III antiarrhythmic medications Hypotensive Effects ■ Butrans may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. Monitor patients during dose initiation or titration Use in Patients with Head Injury or Increased Intracranial Pressure ■ Monitor patients taking Butrans who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression. Avoid the use of Butrans in patients with impaired consciousness or coma

Please read Brief Summary of Full Prescribing Information on the following pages.

Application Site Skin Reactions ■ In rare cases, severe application site skin reactions with signs of marked inflammation including “burn,” “discharge,” and “vesicles” have occurred Anaphylactic/Allergic Reactions ■ Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience Application of External Heat ■ Avoid exposing the Butrans application site and surrounding area to direct external heat sources.

There is a potential for temperature-dependent increases in buprenorphine released from the system resulting in possible overdose and death Use in Patients with Gastrointestinal Conditions ■ Avoid the use of Butrans in patients with paralytic ileus and other GI obstructions. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

ADVERSE REACTIONS ■

Most common adverse reactions (≥5%) reported by patients treated with Butrans in the clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash

Visit Butrans.com for more information or to print Butrans Savings Cards

The first transdermal system to deliver 7 days of buprenorphine

©2015 Purdue Pharma L.P. Stamford, CT 06901-3431 L8365-A 3/15

for transdermal administration BRIEF SUMMARY OF PRESCRIBING INFORMATION (For complete details please see the Full Prescribing Information and Medication Guide.)

WARNING: ADDICTION, ABUSE and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; and NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse BUTRANS® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Assess each patient’s risk prior to prescribing BUTRANS, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1) and Overdosage (10)].

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of BUTRANS. Monitor for respiratory depression, especially during initiation of BUTRANS or following a dose increase. Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death [see Warnings and Precautions (5.2)].

Accidental Exposure Accidental exposure to even one dose of BUTRANS, especially by children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome Prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

4 CONTRAINDICATIONS BUTRANS is contraindicated in patients with: • Significant respiratory depression • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment • Known or suspected paralytic ileus • Hypersensitivity (e.g., anaphylaxis) to buprenorphine [see Warnings and Precautions (5.12) and Adverse Reactions (6)] 5 WARNINGS AND PRECAUTIONS 5.1 Addiction, Abuse, and Misuse BUTRANS contains buprenorphine, a Schedule III controlled substance. As an opioid, BUTRANS exposes users to the risks of addiction, abuse, and misuse.

As modified-release products such as BUTRANS deliver the opioid over an extended period of time, there is a greater risk for overdose and death, due to the larger amount of buprenorphine present. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed BUTRANS and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused [see Drug Abuse and Dependence (9)]. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing BUTRANS, and monitor all patients receiving BUTRANS for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed modified-release opioid formulations such as BUTRANS, but use in such patients necessitates intensive counseling about the risks and proper use of BUTRANS, along with intensive monitoring for signs of addiction, abuse, or misuse. Abuse or misuse of BUTRANS by placing it in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking, overdose and death [see Overdosage (10)]. Opioid agonists such as BUTRANS are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing BUTRANS. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)].

Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 5.2 Life-Threatening Respiratory Depression Serious, lifethreatening, or fatal respiratory depression has been reported with the use of modified-release opioids, even when used as recommended. Respiratory depression, from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage (10)].

Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of BUTRANS, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with BUTRANS and following dose increases. To reduce the risk of respiratory depression, proper dosing and titration of BUTRANS are essential [see Dosage and Administration (2)]. Overestimating the BUTRANS dose when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental exposure to BUTRANS, especially in children, can result in respiratory depression and death due to an overdose of buprenorphine. 5.3 Neonatal Opioid Withdrawal Syndrome Prolonged use of BUTRANS during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. 5.4 Interactions with Central Nervous System Depressants Hypotension,

profound sedation, coma, respiratory depression, and death may result if BUTRANS is used concomitantly with alcohol or other (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). When considering the use of BUTRANS in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression.

Additionally, evaluate the patient’s use of alcohol or illicit drugs that cause CNS depression. If the decision to begin BUTRANS therapy is made, start with BUTRANS 5 mcg/hour patch, monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant [see Drug Interactions (7.2)]. 5.5 Use in Elderly, Cachectic, and Debilitated Patients Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Monitor such patients closely, particularly when initiating and titrating BUTRANS and when BUTRANS is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.2)]. 5.6 Use in Patients with Chronic Pulmonary Disease Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with BUTRANS, as in these patients, even usual therapeutic doses of BUTRANS may decrease respiratory drive to the point of apnea [see Warnings and Precautions (5.2)]. Consider the use of alternative non-opioid analgesics in these patients if possible. 5.7 QTc Prolongation A positive-controlled study of the effects of BUTRANS on the QTc interval in healthy subjects demonstrated no clinically meaningful effect at a BUTRANS dose of 10 mcg/hour; however, a BUTRANS dose of 40 mcg/hour (given as two BUTRANS 20 mcg/hour Transdermal Systems) was observed to prolong the QTc interval [see Dosage and Administration (2.2) and Clinical Pharmacology (12.2)]. Consider these observations in clinical decisions when prescribing BUTRANS to patients with hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia.

Avoid the use of BUTRANS in patients with a history of Long QT Syndrome or an immediate family member with this condition, or those taking Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide).

5.8 Hypotensive Effects BUTRANS may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7.2)]. Monitor these patients for signs of hypotension after initiating or titrating the dose of BUTRANS. 5.9 Use in Patients with Head Injury or Increased Intracranial Pressure Monitor patients taking BUTRANS who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with BUTRANS. BUTRANS may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of BUTRANS in patients with impaired consciousness or coma. 5.10 Hepatotoxicity Although not observed in BUTRANS chronic pain clinical trials, cases of cytolytic hepatitis and hepatitis with jaundice have been observed in individuals receiving sublingual buprenorphine for the treatment of opioid dependence, both in clinical trials and in post-marketing adverse event reports. The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome, and hepatic encephalopathy.

In many cases, the presence of pre-existing liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, concomitant usage of other potentially hepatotoxic drugs, and ongoing injection drug abuse may have played a causative or contributory role. For patients at increased risk of hepatotoxicity (e.g., patients with a history of excessive alcohol intake, intravenous drug abuse or liver disease), obtain baseline liver enzyme levels and monitor periodically and during treatment with BUTRANS. 5.11 Application Site Skin Reactions In rare cases, severe application site skin reactions with signs of marked inflammation including “burn,” “discharge,” and “vesicles” have occurred. Time of onset varies, ranging from days to months following the initiation of BUTRANS treatment. Instruct patients to promptly report the development of severe application site reactions and discontinue therapy. 5.12 Anaphylactic/Allergic Reactions Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. A history of hypersensitivity to buprenorphine is a contraindication to the use of BUTRANS. 5.13 Application of External Heat Advise patients and their caregivers to avoid exposing the BUTRANS application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs, and heated water beds while wearing the system because an increase in absorption of buprenorphine may occur [see Clinical Pharmacology (12.3)]. Advise patients against exposure of the BUTRANS application site and surrounding area to hot water or prolonged exposure to direct sunlight. There is a potential for temperature-dependent increases in buprenorphine released from the system resulting in possible overdose and death. 5.14 Patients with Fever Monitor patients wearing BUTRANS systems who develop fever or increased core body temperature due to strenuous exertion for opioid side effects and adjust the BUTRANS dose if signs of respiratory or central nervous system depression occur.

5.15 Use in Patients with Gastrointestinal Conditions BUTRANS is contraindicated in patients with paralytic ileus. Avoid the use of BUTRANS in patients with other GI obstruction. The buprenorphine in BUTRANS may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase. 5.16 Use in Patients with Convulsive or Seizure Disorders The buprenorphine in BUTRANS may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during BUTRANS therapy. 5.17 Driving and Operating Machinery BUTRANS may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of BUTRANS and know how they will react to the medication. 5.18 Use in Addiction Treatment BUTRANS has not been studied and is not approved for use in the management of addictive disorders. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling:

• Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] • QTc Prolongation [see Warnings and Precautions (5.7)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.3)] • Hypotensive Effects [see Warnings and Precautions (5.8)] • Interactions with Other CNS Depressants [see Warnings and Precautions (5.4)] • Application Site Skin Reactions [see Warnings and Precautions (5.11)] • Anaphylactic/Allergic Reactions [see Warnings and Precautions (5.12)] • Gastrointestinal Effects [see Warnings and Precautions (5.15)] • Seizures [see Warnings and Precautions (5.16)] 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 5,415 patients were treated with BUTRANS in controlled and open-label chronic pain clinical trials. Nine hundred twenty-four subjects were treated for approximately six months and 183 subjects were treated for approximately one year. The clinical trial population consisted of patients with persistent moderate to severe pain. The most common serious adverse drug reactions (all <0.1%) occurring during clinical trials with BUTRANS were: chest pain, abdominal pain, vomiting, dehydration, and hypertension/blood pressure increased. The most common adverse events (≥2%) leading to discontinuation were: nausea, dizziness, vomiting, headache, and somnolence. The most common adverse reactions (≥5%) reported by patients in clinical trials comparing BUTRANS 10 or 20 mcg/hour to placebo are shown in Table 2, and comparing BUTRANS 20 mcg/hour to BUTRANS 5 mcg/hour are shown in Table 3 below: Table 2: Adverse Reactions Reported in ≥5% of Patients during the Open-Label Titration Period and Double-Blind Treatment Period: Opioid-Naïve Patients Open-Label Double-Blind Titration Period Treatment Period BUTRANS BUTRANS Placebo MedDRA (N = 1024) (N = 256) (N = 283) Preferred Term Nausea 23% 13% 10% Dizziness 10% 4% 1% Headache 9% 5% 5% Application site 8% 4% 7% pruritus Somnolence 8% 2% 2% Vomiting 7% 4% 1% Constipation 6% 4% 1% Table 3: Adverse Reactions Reported in ≥5% of Patients during the Open-Label Titration Period and Double-Blind Treatment Period: Opioid-Experienced Patients Open-Label Double-Blind Titration Period Treatment Period BUTRANS BUTRANS 20 BUTRANS 5 MedDRA (N = 1160) (N = 219) (N = 221) Preferred Term Nausea 14% 11% 6% Application site 9% 13% 5% pruritus Headache 9% 8% 3% Somnolence 6% 4% 2% Dizziness 5% 4% 2% Constipation 4% 6% 3% Application site 3% 10% 5% erythema Application 3% 8% 6% site rash Application 2% 6% 2% site irritation The following table lists adverse reactions that were reported in at least 2.0% of patients in four placebo/active-controlled titration-to-effect trials.

Table 4: Adverse Reactions Reported in Titration-to-Effect Placebo/ Active-Controlled Clinical Trials with Incidence ≥2% MedDRA Preferred Term BUTRANS (N = 392) Placebo (N = 261) Nausea Application site pruritus Dizziness Headache Somnolence Constipation Vomiting Application site erythema Application site rash Dry mouth Fatigue Hyperhidrosis Peripheral edema Pruritus Stomach discomfort

21% 15% 15% 14% 13% 13% 9% 7% 6% 6% 5% 4% 3% 3% 2%

6% 12% 7% 9% 4% 5% 1% 2% 6% 2% 1% 1% 1% 0% 0%

The adverse reactions seen in controlled and open-label studies are presented below in the following manner: most common (≥5%), common (≥1% to <5%), and less common (<1%). The most common adverse reactions (≥5%) reported by patients treated with BUTRANS in the clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash. The common (≥1% to <5%) adverse reactions reported by patients treated with BUTRANS in the clinical trials organized by MedDRA (Medical Dictionary for Regulatory Activities) System Organ Class were: Gastrointestinal disorders: diarrhea, dyspepsia, and upper abdominal pain General disorders and administration site conditions: fatigue, peripheral edema, application

site irritation, pain, pyrexia, chest pain, and asthenia Infections and infestations: urinary tract infection, upper respiratory tract infection, nasopharyngitis, influenza, sinusitis, and bronchitis Injury, poisoning and procedural complications: fall Metabolism and nutrition disorders: anorexia Musculoskeletal and connective tissue disorders: back pain, arthralgia, pain in extremity, muscle spasms, musculoskeletal pain, joint swelling, neck pain, and myalgia Nervous system disorders: hypoesthesia, tremor, migraine, and paresthesia Psychiatric disorders: insomnia, anxiety, and depression Respiratory, thoracic and mediastinal disorders: dyspnea, pharyngolaryngeal pain, and cough Skin and subcutaneous tissue disorders: pruritus, hyperhidrosis, rash, and generalized pruritus Vascular disorders: hypertension Other less common adverse reactions, including those known to occur with opioid treatment, that were seen in <1% of the patients in the BUTRANS trials include the following in alphabetical order: Abdominal distention, abdominal pain, accidental injury, affect lability, agitation, alanine aminotransferase increased, angina pectoris, angioedema, apathy, application site dermatitis, asthma aggravated, bradycardia, chills, confusional state, contact dermatitis, coordination abnormal, dehydration, depersonalization, depressed level of consciousness, depressed mood, disorientation, disturbance in attention, diverticulitis, drug hypersensitivity, drug withdrawal syndrome, dry eye, dry skin, dysarthria, dysgeusia, dysphagia, euphoric mood, face edema, flatulence, flushing, gait disturbance, hallucination, hiccups, hot flush, hyperventilation, hypotension, hypoventilation, ileus, insomnia, libido decreased, loss of consciousness, malaise, memory impairment, mental impairment, mental status changes, miosis, muscle weakness, nervousness, nightmare, orthostatic hypotension, palpitations, psychotic disorder, respiration abnormal, respiratory depression, respiratory distress, respiratory failure, restlessness, rhinitis, sedation, sexual dysfunction, syncope, tachycardia, tinnitus, urinary hesitation, urinary incontinence, urinary retention, urticaria, vasodilatation, vertigo, vision blurred, visual disturbance, weight decreased, and wheezing.

7 DRUG INTERACTIONS 7.1 Benzodiazepines There have been a number of reports regarding coma and death associated with the misuse and abuse of the combination of buprenorphine and benzodiazepines. In many, but not all of these cases, buprenorphine was misused by self-injection of crushed buprenorphine tablets. Preclinical studies have shown that the combination of benzodiazepines and buprenorphine altered the usual ceiling effect on buprenorphine-induced respiratory depression, making the respiratory effects of buprenorphine appear similar to those of full opioid agonists. Closely monitor patients with concurrent use of BUTRANS and benzodiazepines. Warn patients that it is extremely dangerous to self-administer benzodiazepines while taking BUTRANS, and warn patients to use benzodiazepines concurrently with BUTRANS only as directed by their physician. 7.2 CNS Depressants The concomitant use of BUTRANS with other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol can increase the risk of respiratory depression, profound sedation, coma and death. Monitor patients receiving CNS depressants and BUTRANS for signs of respiratory depression, sedation, and hypotension.

When combined therapy with any of the above medications is considered, the dose of one or both agents should be reduced [see Dosage and Administration (2.2) and Warnings and Precautions (5.4)]. 7.3 Drugs Affecting Cytochrome P450 Isoenzymes Inhibitors of CYP3A4 and 2D6 Because the CYP3A4 isoenzyme plays a major role in the metabolism of buprenorphine, drugs that inhibit CYP3A4 activity may cause decreased clearance of buprenorphine which could lead to an increase in buprenorphine plasma concentrations and result in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of CYP2D6 and 3A4 inhibitors. If co-administration with BUTRANS is necessary, monitor patients for respiratory depression and sedation at frequent intervals and consider dose adjustments until stable drug effects are achieved [see Clinical Pharmacology (12.3)]. Inducers of CYP3A4 CYP450 3A4 inducers may induce the metabolism of buprenorphine and, therefore, may cause increased clearance of the drug which could lead to a decrease in buprenorphine plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to buprenorphine. After stopping the treatment of a CYP3A4 inducer, as the effects of the inducer decline, the buprenorphine plasma concentration will increase which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression. If co-administration or discontinuation of a CYP3A4 inducer with BUTRANS is necessary, monitor for signs of opioid withdrawal and consider dose adjustments until stable drug effects are achieved [see Clinical Pharmacology (12.3)]. 7.4 Muscle Relaxants Buprenorphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Monitor patients receiving muscle relaxants and BUTRANS for signs of respiratory depression that may be greater than otherwise expected. 7.5 Anticholinergics Anticholinergics or other drugs with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of urinary retention or reduced gastric motility when BUTRANS is used concurrently with anticholinergic drugs. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Clinical Considerations Fetal/neonatal adverse reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see Warnings and Precautions (5.3)]. Teratogenic Effects - Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. BUTRANS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In animal studies, buprenorphine caused an increase in the number of stillborn offspring, reduced litter size, and reduced offspring growth in rats at maternal exposure levels that were approximately 10 times that of human subjects who received one BUTRANS 20 mcg/hour, the maximum recommended human dose (MRHD).

Studies in rats and rabbits demonstrated no evidence of teratogenicity following BUTRANS or subcutaneous (SC) administration of buprenorphine during the period of major organogenesis. Rats were administered up to one BUTRANS 20 mcg/hour every 3 days (gestation days 6, 9, 12, & 15) or received daily SC buprenorphine up to 5 mg/kg (gestation days 6-17). Rabbits were administered four BUTRANS 20 mcg/hour every 3 days (gestation days 6, 9, 12, 15, 18, & 19) or received daily SC buprenorphine up to 5 mg/kg (gestation days 6-19). No teratogenicity was observed at any dose. AUC values for buprenorphine with BUTRANS application and SC injection were approximately 110 and 140 times, respectively, that of human subjects who received the MRHD of one BUTRANS 20 mcg/hour. Non-Teratogenic Effects In a peri- and post-natal study conducted in pregnant and lactating rats, administration of buprenorphine either as BUTRANS or SC buprenorphine was associated with toxicity to offspring. Buprenorphine was present in maternal milk. Pregnant

rats were administered 1/4 of one BUTRANS 5 mcg/hour every 3 days or received daily SC buprenorphine at doses of 0.05, 0.5, or 5 mg/kg from gestation day 6 to lactation day 21 (weaning). Administration of BUTRANS or SC buprenorphine at 0.5 or 5 mg/kg caused maternal toxicity and an increase in the number of stillborns, reduced litter size, and reduced offspring growth at maternal exposure levels that were approximately 10 times that of human subjects who received the MRHD of one BUTRANS 20 mcg/hour. Maternal toxicity was also observed at the no observed adverse effect level (NOAEL) for offspring. 8.2 Labor and Delivery Opioids cross the placenta and may produce respiratory depression in neonates. BUTRANS is not for use in women during and immediately prior to labor, when shorter acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions. However this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. 8.3 Nursing Mothers Buprenorphine is excreted in breast milk. The amount of buprenorphine received by the infant varies depending on the maternal plasma concentration, the amount of milk ingested by the infant, and the extent of first pass metabolism. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of buprenorphine is stopped. Because of the potential for adverse reactions in nursing infants from BUTRANS, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and efficacy of BUTRANS in patients under 18 years of age has not been established. 8.5 Geriatric Use Of the total number of subjects in the clinical trials (5,415), BUTRANS was administered to 1,377 patients aged 65 years and older. Of those, 457 patients were 75 years of age and older. In the clinical program, the incidences of selected BUTRANS-related AEs were higher in older subjects. The incidences of application site AEs were slightly higher among subjects <65 years of age than those ≥65 years of age for both BUTRANS and placebo treatment groups.

In a single-dose study of healthy elderly and healthy young subjects treated with BUTRANS 10 mcg/hour, the pharmacokinetics were similar. In a separate dose-escalation safety study, the pharmacokinetics in the healthy elderly and hypertensive elderly subjects taking thiazide diuretics were similar to those in the healthy young adults. In the elderly groups evaluated, adverse event rates were similar to or lower than rates in healthy young adult subjects, except for constipation and urinary retention, which were more common in the elderly. Although specific dose adjustments on the basis of advanced age are not required for pharmacokinetic reasons, use caution in the elderly population to ensure safe use [see Clinical Pharmacology (12.3)]. 8.6 Hepatic Impairment In a study utilizing intravenous buprenorphine, peak plasma levels (Cmax) and exposure (AUC) of buprenorphine in patients with mild and moderate hepatic impairment did not increase as compared to those observed in subjects with normal hepatic function. BUTRANS has not been evaluated in patients with severe hepatic impairment. As BUTRANS is intended for 7-day dosing, consider the use of alternate analgesic therapy in patients with severe hepatic impairment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance BUTRANS contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids.

BUTRANS can be abused and is subject to misuse, addiction and criminal diversion [see Warnings and Precautions (5.1)]. 9.2 Abuse All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Drug abuse is the intentional non-therapeutic use of an over-the-counter or prescription drug, even once, for its rewarding psychological or physiological effects. Drug abuse includes, but is not limited to the following examples: the use of a prescription or over-the-counter drug to get “high”, or the use of steroids for performance enhancement and muscle build up. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug-seeking” behavior is very common to addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of loss of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. BUTRANS, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful recordkeeping of prescribing information, including quantity, frequency, and renewal requests, as required by state law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to reduce abuse of opioid drugs. Risks Specific to the Abuse of BUTRANS BUTRANS is intended for transdermal use only. Abuse of BUTRANS poses a risk of overdose and death. This risk is increased with concurrent abuse of BUTRANS with alcohol and other substances including other opioids and benzodiazepines [see Warnings and Precautions (5.4) and Drug Interactions (7.2)]. Intentional compromise of the transdermal delivery system will result in the uncontrolled delivery of buprenorphine and pose a significant risk to the abuser that could result in overdose and death [see Warnings and Precautions (5.1)]. Abuse may occur by applying the transdermal system in the absence of legitimate purpose, or by swallowing, snorting, or injecting buprenorphine extracted from the transdermal system. 9.3 Dependence Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, e.g., naloxone, nalmefene, or mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. BUTRANS should not be abruptly discontinued [see Dosage and Administration (2.3)]. If BUTRANS is abruptly discontinued in a physicallydependent patient, an abstinence syndrome may occur. Some or all of the

following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms [see Use in Specific Populations (8.1)]. 10 OVERDOSAGE Clinical Presentation Acute overdosage with BUTRANS is manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations.

Treatment of Overdose In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques. Naloxone may not be effective in reversing any respiratory depression produced by buprenorphine. High doses of naloxone, 10-35 mg/70 kg, may be of limited value in the management of buprenorphine overdose.

The onset of naloxone effect may be delayed by 30 minutes or more. Doxapram hydrochloride (a respiratory stimulant) has also been used. Remove BUTRANS immediately. Because the duration of reversal would be expected to be less than the duration of action of buprenorphine from BUTRANS, carefully monitor the patient until spontaneous respiration is reliably re-established.

Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects as buprenorphine continues to be absorbed from the skin. After removal of BUTRANS, the mean buprenorphine concentrations decrease approximately 50% in 12 hours (range 10-24 hours) with an apparent terminal half-life of approximately 26 hours. Due to this long apparent terminal half-life, patients may require monitoring and treatment for at least 24 hours. In an individual physically dependent on opioids, administration of an opioid receptor antagonist may precipitate an acute withdrawal.

The severity of the withdrawal produced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient with an opioid antagonist, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Addiction, Abuse, and Misuse Inform patients that the use of BUTRANS, even when taken as recommended, can result in addiction, abuse, and misuse, which could lead to overdose and death [see Warnings and Precautions (5.1)]. Instruct patients not to share BUTRANS with others and to take steps to protect BUTRANS from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting BUTRANS or when the dose is increased, and that it can occur even at recommended doses [see Warnings and Precautions (5.2)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Exposure Inform patients that accidental exposure, especially in children, may result in respiratory depression or death [see Warnings and Precautions (5.2)]. Instruct patients to take steps to store BUTRANS securely and to dispose of unused BUTRANS by folding the patch in half and flushing it down the toilet. Neonatal Opioid Withdrawal Syndrome Inform female patients of reproductive potential that prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be lifethreatening if not recognized and treated [see Warnings and Precautions (5.3)].

Interaction with Alcohol and other CNS Depressants Inform patients that potentially serious additive effects may occur if BUTRANS is used with alcohol or other CNS depressants, and not to use such drugs unless supervised by a health care provider. Important Administration Instructions Instruct patients how to properly use BUTRANS, including the following: 1. To carefully follow instructions for the application, removal, and disposal of BUTRANS. Each week, apply BUTRANS to a different site based on the 8 described skin sites, with a minimum of 3 weeks between applications to a previously used site.

2. To apply BUTRANS to a hairless or nearly hairless skin site. If none are available, instruct patients to clip the hair at the site and not to shave the area.

Instruct patients not to apply to irritated skin. If the application site must be cleaned, use clear water only. Soaps, alcohol, oils, lotions, or abrasive devices should not be used. Allow the skin to dry before applying BUTRANS. Hypotension Inform patients that BUTRANS may cause orthostatic hypotension and syncope.

Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position). Driving or Operating Heavy Machinery Inform patients that BUTRANS may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication. Constipation Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention. Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in BUTRANS. Advise patients how to recognize such a reaction and when to seek medical attention.

Pregnancy Advise female patients that BUTRANS can cause fetal harm and to inform the prescriber if they are pregnant or plan to become pregnant.

Disposal Instruct patients to refer to the Instructions for Use for proper disposal of BUTRANS. Patients can dispose of used or unused BUTRANS patches in the trash by sealing them in the Patch-Disposal Unit, following the instructions on the unit. Alternatively, instruct patients to dispose of used patches by folding the adhesive side of the patch to itself, then flushing the patch down the toilet immediately upon removal. Unused patches should be removed from their pouches, the protective liners removed, the patches folded so that the adhesive side of the patch adheres to itself, and immediately flushed down the toilet. Instruct patients to dispose of any patches remaining from a prescription as soon as they are no longer needed.

Healthcare professionals can telephone Purdue Pharma’s Medical Services Department (1-888-726-7535) for information on this product.

Distributed by: Purdue Pharma L.P., Stamford, CT 06901-3431 Manufactured by: LTS Lohmann Therapy Systems Corp., West Caldwell, NJ 07006 U.S. Patent Numbers 5681413; 5804215; 6264980; 6315854; 6344211; RE41408; RE41489; RE41571. © 2014, Purdue Pharma L.P. This brief summary is based on BUTRANS Prescribing Information 303385-0A, Revised 06/2014 (A)

VA PAin C Are Tr Ansform ATion

TM

en

T

con

+ n

eM

e

surroundings E

M

spirit + soul

Personal development

Me

Growing + connecting

Personal life + Work life

Food + drink

Family, Friends + coworkers listening + Being Heard

Hes

S

I

Physical + emotional

oc

L AWAREN

S

N

U DF

Pr

relaxing + Healing

aP

io

Pl

ry

nT

M

energy + flexibility

Power of the Mind

Pre

+ c o

Ta

ve

venTional

working your body

T

e

a

•

n

r

Continued from page 19

recharge

nourishing + fueling

rest + sleep

does that do to my chronic pain? If I don’t like my daughter’s boyfriend, what does that do? Have I had to put my personal aspirations on the shelf? What does that do to my pain? As members of the health care team, we can act as quarterbacks—affirming patients’ worth and their innate strengths and offering options to move toward healing safely. The Wheel of Health can help patients identify the most significant factors in achieving their health and wellness goals and sidestep the distractors to care.

We provide safer care to veterans by working as teams, bringing them a model of coaching and a safety net. It takes a team to work with patients to move them toward their wellness goals. references 1.

2.

figure 1.

WHeel of HealTH

coMMuniTy

areas, is used to help patients appreciate their human complexities (see Figure 1). A wheel out of balance is manifested as chronic pain. For example, if I don’t sleep well, what

3.

Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/ OEF veterans: polytrauma clinical triad. J Rehabil Res Dev. 2009;46(6):697-702.

Dobscha SK, Corson K, Perrin NA, et al. Collaborative care for chronic pain in primary care: a cluster randomized trial. JAMA. 2009;301(12):1242-1252.

Kroenke K, Bair MJ, Damush TM, et al. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009;301(20):2099-2010.

christine rhodes has an MS in nutrition and is a medical writer based in New York City. Besides serving as clinical editor of The Pain Practitioner, she is a Certified Holistic Health Coach, American Association of Drugless Practitioners.

ADDITIONAL PATIENT BOOKS

By Adriaan Louw, PT, PhD, CSMT

Why Are My Nerves So Sensitive?

Neuroscience Education for Patients with CRPS or RSD This book unravels the complex neuroscience behind CRPS/RSD and helps patients understand how the nervous system works while providing treatment techniques to lessen their pain.

Education is Therapy Why Do I Hurt?

A Patient Book About the Neuroscience of Pain Patients learn the science of pain using approachable language and images, allowing them to understand their pain and consequently hurt less, exercise more and regain control of their lives.

24

| T H E PA I N PR ACTITION ER | S P R I N G 2 0 1 6

Louw’s neuroscience education books help patients understand their pain and provide simple strategies for lessening it.

800.367.7393 | OPTP.COM

Chronic Pain & Recovery Center A treatment program with proven results for patients with chronic pain and co-occurring mental illness or addiction. â&#x20AC;˘ 80% of patients who completed our program were either completely off opioids at discharge (63%) or on agonist therapy (17%) â&#x20AC;˘ Patients reported a 24% mean reduction in reported pain To get more information about our treatment outcomes, please call 866.542.4455.

www.silverhillhospital.org

case study

A Progressive Treatment for a Chronic Progressive Disease:

thE WAr AGAinst CoMPlEX rEGionAl PAin syndroME

BY BenJA min K eiZer , PHD, LinDsAY sPosATo, ms, oTr /L , AnD K ATHLeen YAnCoseK , PHD, oTr /L , CHT

“

I just don’t believe it, my pain level is only a 2 right now,” said Thomas at the conclusion of the treatment, slipping on his customized ankle/foot brace. Prior to today’s session, Thomas, a 52-year-old Caucasian man, reported a pain level around 7 or 8 out of 10. As we first observed Thomas, his body language expressed fear and anticipation of pain as he gingerly stood from his chair and started out of the office and down the clinic hallway.

However, unexpected as it may have been to Thomas, with each successive step he appeared more confident that his pain had diminished substantially in the last 60 minutes.

When asked about his familiar pain, Thomas said, “Imagine you are sitting in your chair with the worst case of “pins and needles” [paresthesia] that you can think of. Now imagine standing up and walking down a hallway and every time one of your feet hits the ground you feel like you are walking in burning lava.” For Thomas, that was life with complex regional pain syndrome (CRPS), and the recent treatment provided relief from the “lava.”

CRPS, formerly called reflex sympathetic dystrophy (RSD), typically develops as a localized pain disorder within four to six weeks of a traumatic injury to an upper or lower extremity. Although many traumatic injuries can initially result in CRPS symptoms, most resolve over time without treatment. Adding mystery to this challenging disease state, CRPS may also occur spontaneously without an inciting event (1). Consider how incredibly painful a CRPS pain experience can be. According to the McGill Pain Index, CRPS is one of the most painful conditions that exists. Indeed, the McGill Pain Index score ranks CRPS higher in pain severity than childbirth without

imagine standing up and walking down a hallway and every time one of your feet hits the ground you feel like you are walking in burning lava.

26

| T H E PA I N PR ACTITION ER | S P R I N G 2 0 1 6

training or even amputation of a finger or toe (2).

It was still shocking to Thomas how a few moments changed the trajectory of his life. Several years ago Thomas was undergoing aortic valve replacement and bypass surgery when his heart suddenly shut down. He developed serious complications, including kidney failure, liver failure, and fluid in his lungs. He was kept in a medical coma while his chest remained open for four days to allow a mechanical pump (right ventricular assist device) to assist with heart function. Thomas remained in a coma for the next 14 days and nearly died five times. He spent 30 days in the intensive care unit and an additional three weeks in an inpatient rehabilitation unit. Doctors estimated a 5% chance of survival. Due to unexpected complications, Thomas lost the use of his right leg and left arm.

Thomas eventually regained full use of his left arm.

However, despite intensive rehabilitation, his right leg did not fare as well. Indeed, the aortic valve replacement and bypass surgery resulted in permanent left drop foot and CRPS in both his right foot and anterior lower leg.

In Thomas’ case (and is often the case with CPRS), the medication regimen of oxycodone/acetaminophen and pregabalin was ineffective. Thomas was eventually admitted to the inpatient unit for a five-day continuous subanesthetic ketamine infusion. The ketamine infusion was successful, and he returned to his previous level of functioning.

Clinical symptoms of CRPS fall within four categories: A) sensory, B) vasomotor, C) sudomotor, and D) trophic.

Sensory symptoms include allodynia (painful response to a stimulus that should not be painful) or hyperesthesia (heightened response to a painful stimulus) (3). Vasomotor symptoms include changes in skin color and temperature.

The affected extremity may present as red and hot to the touch (i.e., “warm CRPS”), or may be pale/blue-tinged and cold (i.e., “cold CRPS”). In terms of temperature, approximately 70% of patients initially present with warm CRPS, with the other 30% presenting with cold CRPS (4). In this case, Thomas presented with cold CRPS, a condition

SHUTTERSTOCK / NOmad_SOUl

The War againsT Complex regional pain syndrome

that has been shown to exhibit a worse prognosis when compared to warm CRPS (5). The sudomotor symptoms of CRPS include swelling and sweating asymmetry between the affected and unaffected extremity (3). Trophic symptoms include changes in skin texture (i.e., shiny skin), changes in fingernails (may grow more quickly, or become curved or rigid), or increases or decreases in hair growth (1,3). CRPS may also result in loss of range of motion and cause tremor or weakness (2,5).

CRPS is differentiated between Type I and Type II. A diagnosis of CRPS I is made when no nerve damage has occurred to the affected area. In contrast, the distinguishing factor of CRPS II is nerve damage to the affected area (3).

For unknown reasons Thomasâ&#x20AC;&#x2122; CRPS returned with

CASE STUDY

vengeance one year later. The CRPS not only returned, but progressed to his left leg, which was cold to the touch and exhibited the same blue/purple freckling and hair loss that his right leg had re-developed. How did this happen?

The cause of CRPS remains unknown; however, acceptable theories support a multifactorial origin, with potential contributors being post-traumatic inflammation, neural plasticity, overactivity of the sympathetic nervous system, genetics, and psychosocial factors (1).

Several months later, Thomas was desperate. His pain medicine physician referred him for acupuncture, and Thomas received 17 treatments with some pain relief (average 25% reduction). However, the relief was short lived, lasting anywhere from several hours to the rest of the day THE PAIN PRACTITIONE R

| VOLUME 26, NUMBER 1 |

27

CASE STUDY

The War againsT Complex regional pain syndrome

after the treatment. Both Thomas and his pain medicine physician were desperate for more significant relief and agreed that completing another ketamine infusion was probably the best treatment option. However, there was another non-invasive option.

Benjamin Keizer, PhD, a pain psychologist, worked extensively with military service members with lower extremity CRPS following combat injury and had been experimenting with using two non-invasive electrical stimulation devices synergistically—the Alpha-Stim® Cranial Electrotherapy Stimulation (CES) and the InterX® Therapy device. At his initial visit one year earlier, Thomas completed a psychological evaluation to assess his suitability for a spinal cord stimulator. Due to his high risk of developing an adverse reaction to a surgical intervention, his pain medicine physician made the decision not to implant a spinal cord stimulator. A chance meeting in the waiting room of the Interdisciplinary Pain Clinic and a follow-up conversation with Thomas’ pain medicine physician set the wheels in motion to see if this non-invasive treatment might be an option.

Alpha-Stim CES refers to the application of a small amount of electrical current transcranially, via electrodes

28

| T H E PA I N P R AC T I T I O N E R | S P R I N G 2 0 1 6

attached to the ears. The electrical current is controlled through a handheld device, with treatment lasting approximately 20 minutes to one hour. Originally dubbed “electrosleep,” the intended purpose of CES devices was to induce sleep as part of the “sleep cure” that was popular in early 20th century psychology. Later, researchers demonstrated that CES was not only effective for inducing restful sleep, but it was effective for treating stress-related symptoms as well. Today, the FDA recognizes CES devices for the treatment of anxiety, insomnia, and depression (6). More recent research indicates that CES is effective for pain management, as it stimulates regions of the brain that regulate pain messages, including the cingulate gyrus, insula, and prefrontal cortex (7,8). The ability of CES to modulate pain was demonstrated in a 2013 double-blind randomized controlled trial of individuals with fibromyalgia. In this study, the intervention group that received CES had significantly greater decreases in pain levels than those who received usual care or treatment with a sham device (8).

InterX Therapy, also a type of neurostimulation, has been developed specifically for the treatment of acute and chronic pain. While Alpha-Stim CES is delivered tran-

LET NOTHING STOP THEM.™

Alpha-Stim

When they’re in pain

®

Give your patients sustainable relief, quickly and safely. proVen: Alpha-Stim Significantly Reduces Pain Through rigorous testing, the Alpha-Stim® M has been proven to effectively reduce acute, chronic, and post-traumatic pain by providing Microcurrent Electrical Therapy (MET). Alpha-Stim is: • Cumulative in effectiveness, with most patients showing improvement after the first treatment • Safe, with no serious adverse events in over 30 years

In a study of severe pain patients, Alpha-Stim reduced pain by an average of 71% after only 5 treatment sessions1

Chronic pain patients using Alpha-Stim reported significantly improved functionality compared to the usual care and sham groups2

• Used as a first-line therapy, or as an adjunct to pharmacotherapy (without polypharmacy effects)

Help for your patients is Here.

To get started and to see more clinical data, visit www.alpha-stim.com or call 1-800-for-pain (in USA) or +940-328-0788 (Outside USA).

REFERENCES 1. Holubec JT. Cumulative response from Cranial Electrotherapy Stimulation (CES) for chronic pain. Practical Pain Management. 2009; 9(9):80-83.

2. Taylor AG, Anderson JG, Riedel SL, et al. Cranial Electrotherapy Stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Management Nursing. 2013 Dec; 14(4):327-335.

Alpha-Stim and the Alpha-Stim logo are registered trademarks, and LET NOTHING STOP THEM is a trademark of Electromedical Products International, Inc. ©2016 Electromedical Products International, Inc. All rights reserved.

CASE STUDY

The War againsT Complex regional pain syndrome

Figure 1.

Neuroaccupressure points targeted with InterX® Therapy.

From left to right: saphenous nerve, sural nerve, tibial nerve, deep peroneal nerve.

Figure 2.

Left: Thomas’ feet prior to the treatment in June 2015.

Right: Thomas’ feet following treatment in August 2015.

scranially, InterX Therapy is delivered on the skin of the involved area. InterX Therapy delivers high-amplitude, high-density stimulation through the use of a handheld device or its remote probes, with manufacturer recommended treatments of approximately 15-30 minutes. The number of sessions is left to the clinical judgment of the treating provider (9). Treatment also includes a dynamic component: When appropriate, the patient should complete stretches and/or exercises while stimulation is applied to the points of pain (10).

InterX Therapy is thought to control pain through a combination of several mechanisms. The neurostimulation causes endogenous opioid release, contributing to immediate reduction of pain. Pain relief often continues after the treatment, possibly due to a central nervous system response and neuropeptide/cytokine cascade effect. Additionally, pain perception may be reduced as part of a gatecontrol mechanism (11).

At least two randomized controlled trials have found InterX Therapy to be effective in pain management. In populations with postoperative ankle and femur fractures, participants who received InterX Therapy were found to have significantly less pain than those who were treated with a sham device (12,13).

30

| T H E PA I N PR ACTITION ER | S P R I N G 2 0 1 6

The Treatment Process

The InterX Therapy treatment for Thomas was initiated with the foot that exhibited the least amount of pain and progressed to the areas of most pain. First, the Alpha-Stim CES device was applied to the ears and the InterX device scanned the affected areas that caused the most pain. The working hypothesis was that the Alpha-Stim would initially decrease any central sensitization that was amplifying the signal coming to the brain from his lower extremities. Once the central sensitization decreased, subsequently applying the InterX Therapy would decrease sensitivity and increase range of motion.

Thomas’ allodynia had progressed to the point that something as innocuous as a bedsheet resting gently on the CRPS-affected area caused significant pain. As the first treatment session progressed, Thomas realized that his range of motion was gradually increasing. During the active phase of InterX Therapy treatment, Thomas slowly moved the affected pain areas while the device was applied. By the end of the first treatment, the skin color on both feet began to change back to the original pre-CRPS color. Additionally, Thomas could move his toes and foot in a much larger range of motion and, most importantly for him, he experienced a decrease in his subjective pain experience by

The War againsT Complex regional pain syndrome

approximately 75%.

By June 2015, Thomas participated in two additional treatment sessions that lasted approximately 60 to 75 minutes each. After the third session we procured both of the medical devices for him, taught him how to use the devices, and kept in contact with him during the learning process to answer any questions. Additionally, the acupuncturist treating Thomas gave him a diagram with acupuncture points to focus on during InterX Therapy treatments (Figure 1).

Thomas used the devices at home and his progress continued through his three-month follow-up in August 2015 (Figure 2). Given his success, Thomas was no longer being considered a candidate for a continuous subanesthetic ketamine infusion. Prior to the treatment, Thomas only tolerated working part time as a military intelligence analyst; however, Thomas returned to work full-time in June 2015.

Without a doubt, Thomas was a success story and we desperately want to see more CRPS patients follow this same trajectory. Unfortunately, controversy surrounds the therapeutic management of CRPS. Treatment with pharmacotherapy and noninvasive interventions such as mirror therapy, graded motor imagery, and pain-exposure physical therapy has yielded mixed results (1,14,15). Our hope is that this case provides preliminary support for the use of Alpha-Stim and Inter-X for rapid reduction in CRPS severity. These findings may also lead to hypotheses to drive development of additional novel noninvasive approaches for patients with CRPS. Acknowledgement: The authors wish to thank Patrick Sonnenberg (licensed acupuncturist) for providing information about the neuroaccupressure points, Joshua Yancosek for his rendering of the neuroaccupressure points in Figure 1, and Bob D’Angelo for his photography of the authors.

Disclaimer: The view(s) expressed herein are those of the author(s) and do not reflect the official policy or position of Brooke Army Medical Center, the US Army Medical Department, the US Army Office of the Surgeon General, the Department of the Army, the Department of Defense, or the US Government.

References 1.

2.

3.

4.

Birklein F, O’Neill D, Schlereth T. Complex regional pain syndrome: an optimistic perspective. Neurology. 2015;84(1):89-96.

Wilkie DJ, Savedra MC, Holzemer WL, Tesler MD, Paul SM. Use of the McGill Pain Questionnaire to measure pain: a meta-analysis. Nurs Res.1990; 39(1): 36-41.

Harden RN, Bruehl S, Stanton-Hicks M. Proposed new diagnostic criteria for complex regional pain syndrome. Pain Medicine. 2007;8(4):326-331.

Eberle T, Doganci B, Krämer HH, et al. Warm and cold complex regional pain syndromes Differences beyond skin temperature? Neurology. 2009;72(6): 505-512.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

CASE STUDY

Vaneker M, Wilder‐Smith OH, Schrombges P, Oerlemans HM. Impairments as measured by ISS do not greatly change between one and eight years after CRPS 1 diagnosis. Eur J Pain. 2006;10(7):639-644.

Electromedical Products International. Scientific and clinical literature examination for the Alpha-Stim AID cranial electrotherapy stimulator. Published 2014. Prepared for National Institute for Health and Care Excellence.

Kirsch DL, Price LR, Nichols F, Marksberry JA, Platoni KT. Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. US Army Med Dep J. 2014;Oct-Dec:46-54.

Taylor AG, Anderson JG, Riedel SL, Lewis JE, et al. A randomized, controlled, double-blind pilot study of the effects of cranial electrical stimulation on activity in brain pain processing regions in individuals with fibromyalgia. Explore.

2013;9(1):32-40.

Neuro Resource Group. Frequently asked questions for patients. InterX Therapy. http://www.interx.com/patient_faqs.php. Published 2013. Accessed December 29, 2015.

Neuro Resource Group. InterX Therapy. http://www.interx.com/docs/InterX_Introduction_Sheet.pdf. Published 2008. Accessed December 29, 2015.

Neuro Resource Group. Frequently asked questions for professionals. InterX Therapy. http://www.interx.com/professional_faqs.php. Published 2013. Accessed December 29, 2015.

Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Use of noninvasive interactive neurostimulation to improve short-term recovery in patients with surgically repaired bimalleolar ankle fractures: a prospective, randomized clinical trial. J Foot Ankle Surg. 2010;49(5):432-437.

Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reschetnyak VK, Uskov ON. Non-invasive interactive neurostimulation in the post-operative recovery of patients with a trochanteric fracture of the femur. J Bone Joint Surgery Br. 2007;89(11):1488-1494.

Cossins L, Okell RW, Cameron H, Simpson B, Poole HM, Goebel A. Treatment of complex regional pain syndrome in adults: a systematic review of randomized controlled trials published from June 2000 to February 2012. Eur J Pain.

2013;17(2):158-173.

O’Connell NE, Wand BM, McAuley J, Marston L, Moseley GL. Interventions for treating pain and disability in adults with complex regional pain syndrome: an overview of systematic reviews. Cochrane Database of Syst Revs. 2013;4:1-68

Benjamin Keizer, PhD, (left) works for the Army Medical Department as

leader of the Rehabilitation and Performance Psychology group at the Center for the Intrepid (CFI), Fort Sam Houston, Texas. As one of the premier outpatient rehabilitation centers for the Department of Defense, the CFI provides advanced, interdisciplinary care for military service members who sustained serious injuries (e.g., amputation, limb-salvage, multi-trauma, major surgery). He earned his doctorate at the University of Louisville in counseling psychology before completing a two year post-doctoral fellowship in health psychology at San Antonio Military Medical Center.

Lindsay Sposato, MS, OTR/L (center) is a first lieutenant in the United

States Army. She is a Senior Fellow in the Army-Baylor University Doctor of Science in Occupational Therapy Program. She is interested in the relationship between disability and employment. She has written about dignity therapy and is currently engaged in research about the psychosocial adaptation to limb salvage.

Kathleen Yancosek, PhD, (right) is a lieutenant colonel in the United

States Army. She currently serves as the director of the CFI. She earned her doctorate at the University of Kentucky in Rehabilitation Science before completing a two year post-doctoral fellowship at the United States Army Research Institute of Environmental Medicine in Natick Massachusetts. Her research interests relate to rehabilitation of traumatic upper limb injuries.

THE PAIN PRACTITIONE R

| VOLUME 26, NUMBER 1 |

31

FROM THE CLINIC

Avoiding Electronic Medical Record Pitfalls in Chronic Pain Management

By Bret t SnodgraSS, aPrn, FnP-C

Gone are the days of digging through filing cabinets for patient charts or racing through the office looking everywhere for that lost chart while the patient waits in the exam room. We have come a long way with the addition of the electronic medical record (EMR) to the office. It can be as simple as a click of the mouse to check patients in for their visits or alert the provider that the patient is ready to be seen. Test results can be uploaded effortlessly from the laboratory. Health care providers have the patient’s chart at their disposal any time of day or night, as long as they have access to a computer. EMRs no doubt have made some jobs easier and more efficient.

In fact, a 2008 study in the Archives of Internal Medicine reported that physicians who used electronic health records were less likely to have paid malpractice claims. Why? Increased legibility and improved follow-up through the electronic system reduce adverse outcomes and have made health care providers more easily defensible, if a lawsuit occurs (1). Communication between patients and their health care providers has improved and become more fluid.

So, are there downfalls to the electronic medical record?

Yes, some (2,3). For one thing, the beautiful templates and perfectly legible documents can be easily filled with pages of irrelevant, erroneous, repetitious information. In an EMR, it is easy to track who has accessed the record and when it was accessed. It is also easy to discover what

32

| T H E PA I N PR ACTITION ER | S P R I N G 2 0 1 6

changes were made to the document and when those changes took place. This can lead to serious questions about a provider’s own conduct. For instance, say your visit with the patient took place two weeks prior to “charting” it on the medical record. Can you actually recall the patient’s complaints or the physical exam from that long ago? With that lapse in time, it is easy to see how questions could arise. Consider the instance of a physician supervising a nurse practitioner. Is it customary for the physician to access the charts at 2:00 am, and only spend about 14 seconds reviewing that chart? Did the physician actually review that chart thoroughly? EMRs are time-stamped, which is fully discoverable and, thus, create a trail that is a “true digital fingerprint” (4).

Unfortunately, the sea of information that the EMR now provides can become quite overwhelming. Electronic prompts and alerts that flag abnormal test results or indicate potential medication interactions can easily be ignored. We get used to simply clicking through the record, which could allow us to miss valuable information set up by the system. E-prescribing medications directly to the pharmacy has become commonplace, but the ease with which the prescription can be generated with a single click may lead to serious errors if it is done mechanically and not mindfully.

It has also been found that EMRs actually create a “dulling of the senses.” “Alert fatigue” is a new term meaning that providers begin to ignore alerts automated by the EMR. It is easy to be lulled into a state of fatigue and ignore these alerts all together. A provider may receive on average 150 alerts daily about matters in the EMR ranging from redundancy, suggested follow-up, or dosage discrepancies, just to name a few (5). With so many alerts, providers can forget to check the pertinent information before prescribing, treating, or ordering necessary diagnostics, yet there is discoverable digital proof within all EHRs that a red flag was, in fact, waved.

Another pitfall associated with the use of EMRs is cloning of the medical record at follow-up appointments.

When a provider “copies and pastes” a portion, or in some circumstances an entire progress note, into the recurring

FROM THE CLINIC

visit note, it is imperative that information from the past visit be removed. For instance, if a patient’s family member passes away, it is often noted in the chart. If this information keeps getting copied and pasted, it appears that the patient’s “grandmother passed away last Thursday” at every visit. This creates a question regarding the validity of the entire note. It is imperative that charts with “copy and pasted” sections be thoroughly reviewed for any discrepancies at each visit and that the information be pertinent to the current visit before the document is saved (5).

While litigation is never welcome, we as providers know it can occur. Malpractice insurance carriers now recommend if you are sued to not immediately review the record as you would very likely want to do. Instead, they recommend that you wait for a hard copy to be provided to you from your attorney. The idea is that a sudden review of the chart can be suggestive of the health care provider’s doubts or question about the care rendered. As a provider, you also may be inclined to add or change information, or enhance or add details to the record, and, again, these changes are all discoverable (4).

With health care providers seeing a greater number of

now!

free memberShiP for StudentS & reSidentS!

patients each day, the need for EMRs becomes evident.

They can be a tool that is vital and efficient in the care of the 21st century patient. However, along with their reliability and ease in use are pitfalls we all must be aware of and continually combat to provide our patients with the safest and best care available. It is our responsibility to ensure the most up-to-date, correct record possible.

References 1.

2.

3.

4.

Virapongse A, Bates D, Shu P, et al. Electronic health medical records and malpractice claims in office practices. Arch Intern Med. 2008;168(21):23622367.

Snodgrass B. The importance of thorough chart documentation in the chronic pain patient. PAINweek J. 2015;3(1) 34-39.

Wolver S. EHR Pearls and Pitfalls. Slide presentation; March 7, 2015. https:// www.acponline.org/about_acp/chapters/va/15mtg/wolver.pdf. Accessed February 12, 2016.

Segal J. Avoiding EHR-related liability. 2012. http://blog.medicaljustice.com/ avoiding-ehr-related-liability/. Accessed February 3, 2016.

5. Menachami M, Collum, T. Benefits and drawbacks of electronic health record systems. Risk Manag Healthc Policy. 2011;4:47-55.

Brett B. Snodgrass APRN, FNP-C, is director of clinical operations at the LifeLinc Pain Center in Cordova, Tennessee; the owner of BBS Consultants, specializing in chronic pain education; and the Tennessee state representative to the American Association of Nurse Practitioners.

Home Pain Medication Lock Box

• Fold-down handle for easy storage

• Tamper-proof hinges

on the inside to prevent tampering

• Vented side walls for refrigerator use

• Easily removable divider

inside box to organize weekly pills

Be a part of the largest professional pain management organization in the country! The American Academy of Pain Management is pleased to offer complimentary memberships to full-time students and residents.

Benefits include: • Access the Academy’s “Members Only” section of the website • Access to the online learning center • A printable membership certificate To qualify for a free membership, you must provide proof of full-time student or resident status annually.

JOIN TODAY AT WWW.AAPAINMANAGE.ORG/MEMBERSHIP/

CALL $5 D FOR ISCO PATI UNT E COUP NT ONS

• Emergency breakable access panel on the bottom

• Pre-drilled holes

on the bottom to secure the box

Products to Safeguard Pain Medication at Home Multiple products starting at $19.99 LOCKMED products are available at Pharmacies nationwide, or Call to order at (888) 458-2746, or via www.LOCKMED.com

T H E PA I N P R AC T I T I O N E R

| VOLUME 26 NUMBER 1 |

33

FROM THE CLINIC

Ask the expert

how Can I help a patient in pain Who is Fearful of Movement?

RogeR Mignosa, Do

Function, energy level, sleep quality, mood, and many other quality of life measures are altered in the presence of pain and the resulting lack of movement. When a person is suffering from pain and fearful of movement there is an enormous barrier to achieving health. Among all therapeutic interventions, exercise stands out as the least invasive and most effective method to help patients in pain.

Q: How can I help a patient in pain who is fearful of movement?

Kinesiophobia is defined as the fear of movement. Movement is necessary for healing. If fear of movement dominates a person’s life, then suffering and disability will increase.

When patients are fearful of movement they have likely seen many physicians and attempted multiple interventions, including physical therapy, injections, medications, and possibly surgery. With pain it is common Figure 1. to become depressed and decrease activity. And with inactivity every system (cardiovascular, musculoskeletal, immune) becomes weaker. As weakness increases, function and quality of life decrease.

The deep-seated pathology within pain medicine is the lack of understanding of movement and its relationship to every system within the body. Modern diagnostics and therapeutics fail in addressing movement. The body is made to move. When the body moves force is absorbed and transferred along a kinetic chain that begins with the foot and extends through the torso to the opposite arm. Regardless of the location of pain, the restrictions within the kinetic chain must be addressed to understand the diagnosis. Physical pain is often the product of pathology within the kinetic chain. It is not simply pathology within a joint, ligament, nerve, or muscle. It is an alteration of shock absorption and energy transfer that causes pain and prevents healing. The health of the entire body and each system housed within it is dependent upon 34

| T H E PA I N PR ACTITION ER | S P R I N G 2 0 1 6

the health of the kinetic chain.

If a patient suffers from back, knee, or shoulder pain the entire kinetic chain must be addressed. This requires an evaluation of energy transfer and compensation from heel strike to arm swing. Each joint compensates in a predictable fashion to balance the talus, tibia, femur, pelvis, ribs, scapula, and humerus. The site of the pain is only one detail in the health of the body. The integrity of each link along the kinetic chain tells the complete story of the health of the system, and medicine must treat the body as one unit. See Figure 1.

Q: What is a movement diagnosis?

There are three categories of diagnosis in medicine: 1) chief complaint, 2) structural, 3) movement. For example, in the case of knee pain a chief complaint diagnosis would be “left knee pain.” On this same patient it is possible to give a structural diagnosis of “left knee osteoarthritis.” A common movement diagnosis that would accompany this injury would be “right kinetic chain restriction with anterior rotation of the right pelvis and limited hip mobility.”

The movement diagnosis contains details that encapsulate the complexity of health to help guide rational treatment.

The movement diagnosis addresses the cause of pain.

If the right pelvis is restricted then the left kinetic chain must compensate. It is likely that the left shoe has a pattern of increased wear, as a person with right kinetic chain restriction will favor the right lower extremity and place a disproportionate amount of weight on the left lower extremity. If this patient has poor mechanics and muscular imbalances affecting the left knee joint, the increased pressure on the left knee will accelerate osteoarthritis. If this patient were sent to physical therapy for left knee osteoarthritis and the therapist only focused on the left knee, the problem would not be corrected. As a result the patient may become fearful of movement and develop a sense of hopelessness. For hope to conquer fear, medicine must address movement.

In summary, kinesiophobia is well known in pain medicine and can be addressed by the integration of personalized medicine with the science of movement. It is with this integration that the roots of pain may be found.

Roger Mignosa, DO, is a physicial medicine and rehabilitation physician, clinical professor, and exercise physiologist in San Diego, California.

100+ million people have chronic pain.

They want the most up-to-date and compassionate care available.

Show them you can provide it.

The American Academy of Pain Management offers Two TyPes of advanced education for clinicians who care for people with pain.

Choose the program that is right for you:

the general credentialed pain practitioner (gcpp)

the aDvanceD credentialed pain practitioner (acpp)

This general knowledge test, open to all clinicians who care for people with pain, is intended to evaluate the practitionerâ&#x20AC;&#x2122;s knowledge of pain management principles.

For MDs and DOs only, this program is designed to allow prescribers to demonstrate a superior level of knowledge, particularly about pharmacology.

NEW! streamlined credentialing application process!

Our new eligibility criteria make it easier than ever to apply to become credentialed: applicants must have two years of clinical experience and a valid clinical license without restrictions.

The application process is the same for both programs.

To apply, simply send us: 1. The application form 2. A copy of your clinical license 3. Your CV

DownloaD the application from the acaDemy website www.aapainmanage.org/credentialing anD begin toDay! email: credentialing@aapainmanage.org or call: (209) 288-2205

COMMENTARY

Opioid Prescribing: Dosage Threshold or Ceiling?

By K atie Duensing, JD

P

rescribing opioid analgesics to treat pain has never been under as much scrutiny as it is right now, and both patients and prescribers are feeling the pressure. With the impending release (at the time of writing) of the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, in addition to the proliferation of similar guidelines set forth by state statutes, regulations, medical boards, and departments of health, clinicians are acutely aware that their prescribing practices are being closely scrutinized. And while these practice guidelines are all well-intentioned, they often create as much confusion as they resolve. In fact, hardly a week goes by that the American Academy of Pain Management isn’t contacted by a concerned clinician or patient who is trying to better understand his or her rights and responsibilities, as well as best practices and legal requirements, pertaining to using opioids to treat pain.

While all aspects of practice guidelines elicit questions, it is the relatively novel use of dosage thresholds that is prompting questions around the nation. Clinicians are asking: “What is a dosage threshold? Is it equivalent to a ceiling dose?” “What do I do if a patient requires more medication than my state’s dosage threshold?” “Must I lower a dosage that has proven to be effective and well-tolerated by the patient?”

“How will the CDC guidelines work alongside the already existing state guidelines?” Unfortunately, the answers to those questions are highly dependent upon one’s locale, profession, qualifications, the condition being treated, and more.

Academy staff members have invested considerable time over the past few months analyzing these guidelines to better understand their current status, to identify opportunities for improvement, and ultimately, to help our members offer the best possible care to their patients.

What Is a Dosage Threshold?

Generally speaking, a dosage threshold is the dose in mg/day of morphine equivalent dose at which a clinician is either recommended or required to reevaluate their patient’s treatment plan and progress in certain ways. The range of actions is broad. In some states, reaching the dosage threshold will merely trigger a recommended reevaluation of the patient and the use of caution. Elsewhere, reaching the dosage threshold will necessitate a mandatory consultation with a pain management specialist.

36

| T H E PA I N PR ACTITION ER | S P R I N G 2 0 1 6

Perhaps, though, it is just as important to understand what a dosage threshold is not. A dosage threshold is not a dosage ceiling in any currently promulgated guideline that either (1) has the force and effect of law at the time of writing (statutes and regulations), or (2) is the currently adopted guideline or policy statement of a state medical board or other similar agency responsible for licensing and disciplining physicians. This means that while prescribers may have to meet certain evaluation and documentation requirements if they exceed a dosage threshold, they do not have to keep all of their patients below that threshold, nor should they feel pressured to titrate doses downward for patients who are living healthy and productive lives on an effective and well-tolerated dosage higher than the threshold. These thresholds are intended to issue a “proceed with caution” warning to prescribers, and are not intended to overrule the prescriber’s clinical judgement. So long as practitioners proceed cautiously, heed guideline requirements and/or recommendations, document compliance with those requirements and recommendations, and act in good faith and within their scope of practice, they should feel comfortable in prescribing the appropriate dosage of medication required for each patient’s specific needs, whether that dosage exceeds the state’s dosage threshold or not.

What Are the Requirements in my State Relating to Dosage Thresholds?

Currently, only seven states have set dosage thresholds that trigger required or strongly recommended action: California, Colorado, Indiana, Ohio, Rhode Island, South Carolina, and Washington. Of these states, four recommend certain action upon reaching the dosage threshold and three require certain action upon reaching the dosage threshold. Because judges, juries, and medical boards will defer to these guidelines and often consider them the “standard of practice,” the Academy recommends that clinicians err on the side of treating stateissued recommendations as requirements, and practice accordingly, in order to avoid potential sanctions.

While only a handful of states have adopted dosage thresholds, their use does seem to be on the rise. However, it is important to note that none of the states that have implemented these thresholds have agreed on the best way to do so. While they all share a theme of caution and some variation on reevaluation, the dosage thresholds range from 60 to 120 mg/day in morphine milligram equivalent (MME)

OpiOid prescribing: dOsage ThreshOld Or ceiling? | COMMENTARY

doses, and all differ in their requirements and recommendations pertaining to referrals, consultations, prescription monitoring program checks, consideration of opioid antagonists (naloxone), treatment plans, and more.

It is vital that all prescribers become familiar with the practice guidelines that are in effect within their own states.

The chart below illustrates how inconsistent the actions triggered by the currently adopted dosage thresholds are around the country.

How the CDC Guidelines Would Affect Dosage Thresholds

At the time of this writing, we are just past the end of a 30-day comment period, during which the CDC received more than 4,000 comments on its draft Guideline for Prescribing Opioids Dosage Thresholds by State (mg/day) ■ Requirements ■ Recommendations 0

20

40

60

80

100

120

indiana

Face-to-face review of treatment plan required; revise plan; consider referral.

60 mg/day

califOrnia

Proceed with caution; consider referral to specialist for higher doses.

80 mg/day

OhiO

Strongly consider: reestablishing informed consent; reviewing treatment objectives and current status; reviewing OARRS; consultation.

80 mg/day

Some Closing Words

sOuTh carOlina

Strongly consider: reestablishing informed 80 mg/day consent; reviewing treatment objectives and current status; reviewing SCRIPTS; consultation; Naloxone.

cOlOradO

For higher doses, prescribers should use clinical judgment; use additional safeguards; consult a specialist or refer the patient; and dispensers should be more cautious.

120 mg/day

rhOde island

Consideration of consultation with a Pain Medicine Physician is required and must be documented in the medical record.

120 mg/day

WashingTOn

Consultation with a pain management specialist is required, with exceptions found in WAC 246-919-861 or 246-919-862.

for Chronic Pain. However, the draft circulated in mid-December recommends implementing additional precautions when increasing dosage to > 50 morphine milligram equivalents (MME)/day, and further, states that primary care prescribers “… should generally avoid increasing dosage to > 90 MME/ day.” With the first dosage threshold set at 50 MME/day, and a “soft limit” set at 90 MME/day, these would be the most restrictive dosage thresholds set to date. The Academy has significant concerns with this particular recommendation in the proposed guidelines, which you can read about in the comments that were submitted to the CDC during its open comment period, found at bit.ly/1WBxBMM. So, when the CDC guidelines are final, how will they affect you? It is very important to realize the CDC guidelines are intended to be taken as recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

As recommendations, the guidelines will not be, per se, binding. However, due to the deference historically given to the CDC, it is entirely possible that legislators and regulators will codify portions of the guideline, if not the entire guideline. If dosage thresholds are codified as legally binding ceilings, anything prescribed above and beyond those ceilings will result in a clinician violating the legal standard of care. Even without codification of the recommendations, in legal settings, expert witnesses will point to this “soft limit” and suggest to judges and juries that prescribing in excess of this dose is tantamount to unprofessional conduct and malpractice. Third-party payers, including Medicare and Medicaid, may begin to treat the “soft limit” as a ceiling dose, reducing reimbursement for higher doses and/or establishing prior authorization protocols that effectively ban higher doses.

120 mg/day

When utilized appropriately, dosage thresholds are an opportunity for prescribers to pause, re-evaluate, and ensure that progress is being made and that patients are receiving optimal care for their conditions. However, when dosage thresholds are misunderstood or misused, they can create negative unintended consequences, potentially resulting in under-treatment for patients and harsh scrutiny for prescribers. Reining in prescribing in general may not be a bad idea, but reining in prescribing because of arbitrary limits that don’t combine your clinical expertise with thorough ongoing assessment of your patient is simply not good practice.

To ensure the best possible outcomes for your patients and your practice, it is vital that you understand what threshold dosages truly mean in your state.

Katie Duensing, JD, is a member of the American Academy of Pain Management’s policy and advocacy department, which includes the Academy’s State Pain Policy Advocacy Network.

THE PAIN PRACTITIONE R

| VOLUME 26 NUMBER 1 |

37

DEPARTMENT

|

classified ads, adVerTising direcTOrY

aDVeRtising DiReCtORy TO ADVERTISE IN THE PAIN PRACTITIONER, CONTACT SHEILA MILLER (209)533-9744, SMILLER@AAPAINMANAGE.ORG

1st Providers Choice-Pain Management EMR IMS Pain Management Specific EMR www.1stproviderschoice.com 480-782-1116 COVER 4

AIS PainCare Intrathecal Pain Medication www.aispaincare.com 877-443-4006

CLassiFieD aDs

TO PLACE A CLASSIFIED ADVERTISEMENT CONTACT SHEILA MILLER (209)533-9744, SMILLER@AAPAINMANAGE.ORG

pracTices WanTed: pain ManageMenT, pM&r, &pT Considering Selling your Practice? We are seeking practices on behalf of qualified buyers. Flexible deal structure, all-cash, with favorable terms.

Option for sellers to remain post-sale as employed providers.

Contact: Mo Majdi 800-416-2055 http://TransitionConsultants.com

PAGE 28

Depomed, Inc. Nucynta ER www.nucynta.com/

510-744-8000

COVER 2

Electromedical Products Inernational, Inc Alpha-Stim www.alpha-stim.com 800-FOR-PAIN (367-7246) PAGE 29

Game Ready www.gameready.com

888-426-3732

COVER 3

LOCKMED Medical Products LOCKMED Home Medication Lock Box www.LOCKMED.com 888-458-2746 PAGE 33

Micro Format Tamper Resistant Rx Paper Products www.RxPaper.com 800-333-0549 PAGE 38

NEUROGENX, Inc. NEUROGENX 4000PRO www.neurogenx.com 800-335-7624 PAGE 9

OPTP Pain education and therapy products www.optp.com 800-367-7393 PAGE 24

Purdue Pharma Butrans www.Butrans.com PAGES 20-23

Silver Hill Hospital Chronic Pain & Recovery Center www.silverhillhospital.org 866-542-4455 PAGE 25

Become pa part of of an an organizatio ion n tha thatt is is impr im pro ovin ing g tthe he w wa ay pain is is ma mana nag ged in tthe he US US....

JOin MOre Than 4,300 clinicians, as Well as ManY hOspiTals, and pracTices, ThaT are MeMbers Of The acadeMY. • Get the education and information you need to confidently care for people with pain • Gain access to the most up-to-date state and federal policies in pain management • Find out how you can get credentialed

chOOse The MeMbership TYpe ThaT’s righT fOr YOu and JOin The acadeMY TOdaY! General Membership Open to all clinicians and affiliates.

Student Membership Complimentary to all full-time students or residents.

Pain Management Facility Membership Open to hospitals, clinics, and other institutions offering interdisciplinary pain management.

JOIN TODAY Phone (209) 533-9744 Online www.aapainmanage.org/join-today

38

| T H E PA I N P R AC T I T I O N E R | S P R I N G 2 0 1 6

BEAT PAIN HEAD TO TOE, WITHOUT NARCOTICS

Game Ready,® is clinically proven to reduce pain and decrease the need for narcotic medications.

Game Ready combines the best in cryotherapy with optional, active compression to beat pain without narcotic medications and accelerate natural tissue repair. The system delivers deeper-penetrating, longer-lasting, pain-relieving cold – and features a comprehensive line of form-fitting, comfortable wraps for treatment head to toe, including the cervical and thoracic spine, lumbar/back, and hip. Game Ready is available by prescription for rental or purchase, allowing you to seamlessly extend your pain management strategy to the patient at home. For superior drug-free pain relief, go with Game Ready.

To learn more about prescribing Game Ready, please visit gameready.com or call us toll-free at 1.888.426-3732.

©2016 CoolSystems, Inc. All rights reserved. AAPM 02/16

NONPROFIT ORG US POSTAGE PAID HAYWARD CA PERMIT #3335 975 Morning Star Drive #A Sonora, CA 95370

Where Customer Service is Our #1 Focus

IMS for Pain Management Providers â&#x20AC;&#x201C;

Pain Management and Physical Medicine - Fully Certified EHR

Fully Certified Pain Management Electronic Health Records & Practice Management Software n Save Valuable Documentation Time with Pain Specific Procedure & Injection Templates n E-Prescribing of ControlledSubstances (EPCS) Ready n Patients Current Medication Automatically download directly into your EMR n Drug Formularies & Insurance Formularies Included n ICD-10 Ready with Pain & Physical Medicine Crosswalk Included from ICD-9 n Cloud Based & Server Based Solutions, I-Pad, Android or Windows Tablet friendly n Head home right as you finish with your last patient with an Efficient Pain Specific EMR & Documentation Software n IMS has the capability to accommodate any Registry submission type for Meaningful Use. This includes HL7, HIE and exportation of several file types.

Call Today for a Free Demo!

Mention this ad for a AAPM Discount!

Call 480-782-1116 | www.1stProvidersChoice.com