PAINWeek Journal Vol 7, Q2

vol. 7 q 2 2019

opioid deprescribing discussions: using MI without having an MI p.20 spuds, screenings & safety: from chips to opioids p.30 the carrot vs. the stick: value based interdisciplinary treament p.38 breaking the waves: medical music psychotherapy in the treatment of pain p.46

PaiNWeeK 2019 Conference Preview P.69

www.painweek.org

KEEP ADVANCING

Shouldn’t opioid treatments continue to change with the times?

MORPHABOND ER With SentryBond™ Technology Is a Single-Agent, Abuse-Deterrent Morphine1,2

IN JE CT IO N

Retains its extended-release properties even if manipulated

IN TR AN AS AL

Bioequivalent to MS Contin®

Expected to deter abuse by both of the following routes:

Abuse of MORPHABOND ER is still possible by intranasal, intravenous, and oral routes INDICATION --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------MORPHABOND™ ER (morphine sulfate) extended-release tablets, for oral use, CII is an opioid agonist 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 risks of overdose and death with extended-release opioid formulations, reserve MORPHABOND ER 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.

MORPHABOND ER is not indicated as an as-needed (prn) analgesic.

IMPORTANT SAFETY INFORMATION BOXED WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse MORPHABOND ER 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 MORPHABOND ER, and monitor all patients regularly for the development of these behaviors and conditions.

References: 1. MORPHABOND ER [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2018. 2. Data on file. Daiichi Sankyo, Inc.

Opioid Analgesic REMS To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.

Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety

For more information, visit MORPHABONDhcp.com

Please see additional Important Safety Information on the following pages.

Please see Brief Summary of full Prescribing Information, including BOXED WARNINGS, on adjacent pages.

IMPORTANT SAFETY INFORMATION BOXED WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS (continued) Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of MORPHABOND ER. Monitor for respiratory depression, especially during initiation of MORPHABOND ER or following a dose increase. Instruct patients to swallow MORPHABOND ER tablets whole; crushing, chewing, or dissolving MORPHABOND ER tablets can cause rapid release and absorption of a potentially fatal dose of morphine.

Accidental Ingestion Accidental ingestion of even one dose of MORPHABOND ER, especially by children, can result in a fatal overdose of morphine.

Neonatal Opioid Withdrawal Syndrome Prolonged use of MORPHABOND ER 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.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

• Reserve concomitant prescribing of MORPHABOND ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate • Limit dosages and durations to the minimum required • Follow patients for signs and symptoms of respiratory depression and sedation

CONTRAINDICATIONS --------------------------------------------------------------------------------------------------

• Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed. The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG • Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them • Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patientprescriber responsibilities

MORPHABOND ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days; known or suspected gastrointestinal obstruction, including paralytic ileus; and hypersensitvity (eg, anaphylaxis) to morphine.

WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse --------------------------------------------------------------------------------------------MORPHABOND ER contains morphine, a Schedule II controlled substance, and thus exposes its users to the risks of addiction, abuse, and misuse.

Because extended-release products such as MORPHABOND 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 morphine present.

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed MORPHABOND ER. 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 MORPHABOND ER, and monitor all patients receiving MORPHABOND ER for development of these behaviors and 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. 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 opioids such as MORPHABOND ER, but use in such patients necessitates intensive counseling about the risks of proper use of MORPHABOND ER along with intensive monitoring for signs of addiction, abuse, and misuse.

Abuse or misuse of MORPHABOND ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of morphine and can result in overdose and death. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing MORPHABOND ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper storage and 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.

Opioid Analgesic REMS --------------------------------------------------------------------------------------------------------------To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following: • Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain

Life-Threatening Respiratory Depression ------------------------------------------------------------

Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended, and 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 MORPHABOND ER, the risk is greatest during the initiation of therapy or following a dosage increase. Closely monitor patients for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases with MORPHABOND ER. To reduce the risk of respiratory depression, proper dosing and titration of MORPHABOND ER are essential. Overestimating the MORPHABOND ER dosage when converting patients from another opioid product can result in fatal overdose with the first dose.

Neonatal Opioid Withdrawal Syndrome ---------------------------------------------------------------Prolonged use of MORPHABOND ER during pregnancy can result in withdrawal 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. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants ----------------------------------------------------------------------------------------------------------------------------------Profound sedation, respiratory depression, coma, and death may result from the concomitant use of MORPHABOND ER with benzodiazepines or other CNS system depressants (eg, non-benzodiazepine sedatives/ hypnotics, tranquilizers, muscle relaxants, general anesthetics, anxiolytics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risks of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with concomitant use of other CNS depressant drugs with opioid analgesics.

Please see additional Important Safety Information on the following pages.

Please see Brief Summary of full Prescribing Information, including BOXED WARNINGS, on adjacent pages.

WARNINGS AND PRECAUTIONS Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants (continued) -----------------------------------------------------------------------------------------------

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness --------------------

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.

Advise both patients and caregivers about the risks of respiratory depression and sedation when MORPHABOND ER is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs.

In patients who may be susceptible to the intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors), MORPHABOND ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with MORPHABOND ER. Opioids may also obscure the clinical course in a patient with a head injury.

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

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients ---------------------------------------------------------------------------------------------------------------------------

The morphine in MORPHABOND ER may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during MORPHABOND ER therapy.

The use of MORPHABOND ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Patients with Chronic Pulmonary Disease: MORPHABOND ER-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of MORPHABOND ER. 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 compared to younger, healthier patients.

Monitor such patients closely, particularly when initiating and titrating MORPHABOND ER and when MORPHABOND ER is given concomitantly with other drugs that depress respiration. Alternatively, consider the use of nonopioid analgesics in these patients.

Interaction with Monoamine Oxidase Inhibitors ----------------------------------------

Risks of Use in Patients with Gastrointestinal Conditions ------------

MORPHABOND ER is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus.

The morphine in MORPHABOND ER may cause spasm of the sphincter of Oddi.

Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Increased Risk of Seizures in Patients with Seizure Disorders -----------------------------------------------------------------------------------------------------------------------------------

Withdrawal ---------------------------------------------------------------------------------------------------------------------------------------------------Avoid the use of mixed agonist/antagonist (eg, pentazocine, nalbuphine, and butorphanol) or partial agonist (eg, buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including MORPHABOND ER. In these patients, mixed agonists/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

When discontinuing MORPHABOND ER, gradually taper the dosage. Do not abruptly discontinue MORPHABOND ER.

Risks of Driving and Operating Machinery --------------------------------------------------------MORPHABOND 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 MORPHABOND ER and know how they will react to the medication.

Adverse Reactions -------------------------------------------------------------------------------------------------------------------------------

Monoamine oxidase inhibitors (MAOIs) may potentiate the effects of morphine, including respiratory depression, coma, and confusion.

MORPHABOND ER should not be used in patients taking MAOIs or within 14 days of stopping such treatment.

In clinical trials, the most common adverse reactions with morphine sulfate extended-release were constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoric mood.

Adrenal Insufficiency -----------------------------------------------------------------------------------------------------------------------

• Concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of respiratory depression, profound sedation, coma and death • The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome • Mixed agonist/antagonist and partial agonist opioid analgesics may reduce the analgesic effect of MORPHABOND ER and/or may precipitate withdrawal symptoms • Morphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression • MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (eg, respiratory depression, coma) • The concomitant use of cimetidine can potentiate morphine effects and increase risk of hypotension, respiratory depression, profound sedation, coma, and death • Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone • The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus • The concomitant use of P-gp-inhibitors can increase the exposure to morphine by about two-fold and can increase risk of hypotension, respiratory depression, profound sedation, coma, and death

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

Severe Hypotension --------------------------------------------------------------------------------------------------------------------------MORPHABOND ER 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 (eg, phenothiazines or general anesthetics).

Monitor these patients for signs of hypotension after initiating or titrating the dosage of MORPHABOND ER. In patients with circulatory shock, MORPHABOND ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of MORPHABOND ER in patients with circulatory shock.

Drug Interactions -----------------------------------------------------------------------------------------------------------------------------------

©2019 Daiichi Sankyo, Inc. MORPHABOND ER and the MORPHABOND ER logo are trademarks of INSPIRION DELIVERY SCIENCES LLC. Other trademarks are the property of their respective owners. PP-US-MB-0935 05/19

MORPHABOND™ ER (morphine sulfate) extended-release tablets, for oral use CII Initial U.S. Approval: 1941 BRIEF SUMMARY: See package insert for full prescribing information.

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse MORPHABOND™ ER 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 MORPHABOND ER, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings and Precautions (5.2)]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of MORPHABOND ER. Monitor for respiratory depression, especially during initiation of MORPHABOND ER or following a dose increase.

Instruct patients to swallow MORPHABOND ER tablets whole; crushing, chewing, or dissolving MORPHABOND ER tablets can cause rapid release and absorption of a potentially fatal dose of morphine [see Warnings and Precautions (5.3)].

Accidental Ingestion Accidental ingestion of even one dose of MORPHABOND ER, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.3)].

Neonatal Opioid Withdrawal Syndrome Prolonged use of MORPHABOND ER 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 (5.4)].

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.5), Drug Interactions (7)].

• Reserve concomitant prescribing of MORPHABOND ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

• Limit dosages and durations to the minimum required.

• Follow patients for signs and symptoms of respiratory depression and sedation.

1 INDICATIONS AND USAGE MORPHABOND 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.

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 [see Warnings and Precautions (5.1)], reserve MORPHABOND ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

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

4 CONTRAINDICATIONS MORPHABOND ER is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions (5.3)] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.6)] • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.7)/Drug Interactions (7)] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.11)] • Hypersensitivity (e.g., anaphylaxis) to morphine [see Adverse Reactions (6.2)] 5 WARNINGS AND PRECAUTIONS 5.1 Addiction, Abuse, and Misuse MORPHABOND ER contains morphine, a Schedule II controlled substance. As an opioid, MORPHABOND ER exposes its users to the risks of addiction, abuse, and misuse. Because extended-release products such as MORPHABOND 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 morphine present [see Drug Abuse and Dependence (9)].

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed MORPHABOND ER. 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 MORPHABOND ER, and monitor all patients receiving MORPHABOND ER for development of these behaviors and 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 opioids such as MORPHABOND ER, but use in such patients necessitates intensive counseling about the risks of proper use of MORPHABOND ER along with intensive monitoring for signs of addiction, abuse, and misuse.

Abuse or misuse of MORPHABOND ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of morphine and can result in overdose and death [see Overdosage (10)].

Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing MORPHABOND ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper storage and disposal of unused drug [see Patient Counseling Information (17) in the full prescribing information]. 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 Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to do all of the following: • Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain.

• Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed. The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG. • Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them.

• Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patientprescriber responsibilities.

To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com. The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint.

5.3 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, 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 MORPHABOND ER, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of MORPHABOND ER. To reduce the risk of respiratory depression, proper dosing and titration of MORPHABOND ER are essential [see Dosage and Administration (2) in the full prescribing information]. Overestimating the MORPHABOND ER dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.

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

5.4 Neonatal Opioid Withdrawal Syndrome Prolonged use of MORPHABOND ER during pregnancy can result in withdrawal 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. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations (8.1), Patient Counseling Information (17) in the full prescribing information].

5.5 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of MORPHABOND ER with benzodiazepines or other CNS system depressants (e.g., non-benzodiazepine sedatives/ hypnotics, tranquilizers, muscle relaxants, general anesthetics, anxiolytics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions (7)].

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.

Advise both patients and caregivers about the risks of respiratory depression and sedation when MORPHABOND ER is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.

Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions (7) and Patient Counseling Information (17) in the full prescribing information].

5.6 Life -Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of MORPHABOND ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Patients with Chronic Pulmonary Disease: MORPHABOND ER-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of MORPHABOND ER [see Warnings and Precautions (5.3)].

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 compared to younger, healthier patients [see Warnings and Precautions (5.3)].

Monitor such patients closely, particularly when initiating and titrating MORPHABOND ER and when MORPHABOND ER is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.3, 5.5)]. Alternatively, consider the use of non-opioid analgesics in these patients.

5.7 Interaction with Monoamine Oxidase Inhibitors Monoamine oxidase inhibitors (MAOIs) may potentiate the effects of morphine, including respiratory depression, coma, and confusion. MORPHABOND ER should not be used in patients taking MAOIs or within 14 days of stopping such treatment.

5.8 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

5.9 Severe Hypotension MORPHABOND ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is 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)]. Monitor these patients for signs of hypotension after initiating or titrating the dosage of MORPHABOND ER. In patients with circulatory shock, MORPHABOND ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of MORPHABOND ER in patients with circulatory shock.

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

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

5.11 Risks of Use in Patients with Gastrointestinal Conditions MORPHABOND ER is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

The morphine in MORPHABOND ER may cause spasm of the sphincter of Oddi. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

5.12 Increased Risk of Seizures in Patients with Seizure Disorders The morphine in MORPHABOND ER may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during MORPHABOND ER therapy.

5.13 Withdrawal Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including MORPHABOND ER. In these patients, mixed agonists/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms [see Drug Interactions (7)].

When discontinuing MORPHABOND ER, gradually taper the dosage [see Dosage and Administration (2.5) in the full prescribing information]. Do not abruptly discontinue MORPHABOND ER [see Drug Abuse and Dependence (9.3)].

5.14 Risks of Driving and Operating Machinery MORPHABOND 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 MORPHABOND ER and know how

they will react to the medication [see Patient Counseling Information (17) in the full prescribing information].

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3)] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] • Interactions with Benzodiazepine or Other CNS Depressants [see Warnings and Precautions (5.5)] • Adrenal Insufficiency [see Warnings and Precautions (5.8)] • Severe Hypotension [see Warnings and Precautions (5.9)] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11)] • Seizures [see Warnings and Precautions (5.12)] • Withdrawal [see Warnings and Precautions (5.13)] 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.

MORPHABOND ER may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see Overdosage (10)].

Most Frequently Observed Reactions In clinical trials, the most common adverse reactions with morphine sulfate extended-release were constipation, dizziness, sedation, nausea, vomiting, sweating, dysphoria, and euphoric mood.

Some of these effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.

Less Frequently Observed Reactions Cardiovascular disorders: tachycardia, bradycardia, palpitations Eye disorders: visual impairment, vision blurred, diplopia, miosis Gastrointestinal disorders: dry mouth, diarrhea, abdominal pain, constipation, dyspepsia General disorders and administration site conditions: chills, feeling abnormal, edema, edema peripheral, weakness Hepatobiliary disorders: biliary colic Metabolism and nutrition disorders: anorexia Musculoskeletal and connective tissue disorders: muscle rigidity, muscle twitching Nervous system disorders: presyncope, syncope, headache, tremor, uncoordinated muscle movements, convulsion, intracranial pressure increased, taste alteration, paresthesia, nystagmus Psychiatric disorders: agitation, mood altered, anxiety, depression, abnormal dreams, hallucination, disorientation, insomnia Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effect Reproductive system and breast disorders: reduced libido and/or potency Respiratory, thoracic and mediastinal disorders: laryngospasm Skin and subcutaneous tissue disorders: pruritus, urticaria, rash Vascular disorders: flushing, hypotension, hypertension 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of morphine sulfate. 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.

Amenorrhea, asthenia, bronchospasm, confusional state, drug hypersensitivity, fatigue, hyperalgesia, hypertonia, ileus, increased hepatic enzymes, intestinal obstruction, lethargy, malaise, pulmonary edema, thinking disturbances, somnolence, and vertigo.

Serotonin syndrome: Cases of serotonin syndrome, a potentially lifethreatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in MORPHABOND ER. Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see Clinical Pharmacology (12.2) in the full prescribing information].

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with MORPHABOND ER. Table 1: Clinically Significant Drug Interactions with MORPHABOND ER Benzodiazepines and other Central Nervous System (CNS) Depressants

Clinical Impact:

Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, increase the risk of respiratory depression, profound sedation, coma, and death.

Intervention:

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients closely for signs of respiratory depression and sedation [see Warnings and Precautions (5.5)].

Examples:

Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.

Serotonergic Drugs

Clinical Impact: Intervention:

Example:

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue MORPHABOND ER if serotonin syndrome is suspected.

Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that effect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Monoamine Oxidase Inhibitors (MAOIs)

Clinical Impact:

MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.7)].

Intervention:

Do not use MORPHABOND ER in patients taking MAOIs or within 14 days of stopping such treatment.

Examples:

phenelzine, tranylcypromine, linezolid

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Clinical Impact:

May reduce the analgesic effect of MORPHABOND ER and/or precipitate withdrawal symptoms.

Intervention: Avoid concomitant use.

Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Morphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of MORPHABOND ER and/or the muscle relaxant as necessary.

Cimetidine Clinical Impact: The concomitant use of cimetidine can potentiate morphine effects and increase risk of hypotension, respiratory depression, profound sedation, coma, and death.

Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of MORPHABOND ER and/or cimetidine as necessary.

Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. (continued)

Table 1: Clinically Significant Drug Interactions with MORPHABOND ER

Data

Anticholinergic Drugs

Human Data The results from a population-based prospective cohort, including 70 women exposed to morphine during the first trimester of pregnancy and 448 women exposed to morphine at any time during pregnancy, indicate no increased risk for congenital malformations. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including small sample size and non-randomized study design.

Animal Data Formal reproductive and developmental toxicology studies for morphine have not been conducted. Exposure margins for the following published study reports are based on a human daily dose of 60 mg morphine using a body surface area comparison (HDD).

Neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of morphine sulfate (35-322 mg/kg) on Gestation Day 8 to pregnant hamsters (4.7 to 43.5 times the HDD). A no adverse effect level was not defined in this study and the findings cannot be clearly attributed to maternal toxicity. Neural tube defects (exencephaly), axial skeletal fusions, and cryptorchidism were reported following a single subcutaneous (SC) injection of morphine sulfate to pregnant mice (100-500 mg/kg) on Gestation Day 8 or 9 at 200 mg/kg or greater (16 times the HDD) and fetal resorption at 400 mg/kg or higher (32 times the HDD).

No adverse effects were noted following 100 mg/kg morphine in this model (8 times the HDD). In one study, following continuous subcutaneous infusion of doses greater than or equal to 2.72 mg/kg to mice (0.2 times the HDD), exencephaly, hydronephrosis, intestinal hemorrhage, split supraoccipital, malformed sternebrae, and malformed xiphoid were noted.

The effects were reduced with increasing daily dose; possibly due to rapid induction of tolerance under these infusion conditions. The clinical significance of this report is not clear.

Decreased fetal weights were observed in pregnant rats treated with 20 mg/kg/day morphine sulfate (3.2 times the HDD) from Gestation Day 7 to 9. There was no evidence of malformations despite maternal toxicity (10% mortality). In a second rat study, decreased fetal weight and increased incidences of growth retardation were noted at 35 mg/kg/day (5.7 times the HDD) and there was a reduced number of fetuses at 70 mg/kg/day (11.4 times the HDD) when pregnant rats were treated with 10, 35, or 70 mg/kg/day morphine sulfate via continuous infusion from Gestation Day 5 to 20. There was no evidence of fetal malformations or maternal toxicity.

An increased incidence of abortion was noted in a study in which pregnant rabbits were treated with 2.5 (0.8 times the HDD) to 10 mg/kg morphine sulfate via subcutaneous injection from Gestation Day 6 to 10. In a second study, decreased fetal body weights were reported following treatment of pregnant rabbits with increasing doses of morphine (10-50 mg/kg/day) during the pre-mating period and 50 mg/kg/day (16 times the HDD) throughout the gestation period. No overt malformations were reported in either publication; although only limited endpoints were evaluated.

In published studies in rats, exposure to morphine during gestation and/or lactation periods is associated with: decreased pup viability at 12.5 mg/kg/day or greater (2 times the HDD); decreased pup body weights at 15 mg/kg/day or greater (2.4 times the HDD); decreased litter size, decreased absolute brain and cerebellar weights, cyanosis, and hypothermia at 20 mg/kg/day (3.2 times the HDD); alteration of behavioral responses (play, socialinteraction) at 1 mg/kg/day or greater (0.2 times the HDD); alteration of maternal behaviors (e.g., decreased nursing and pup retrievals) in mice at 1 mg/kg or higher (0.08 times the HDD) and rats at 1.5 mg/kg/day or higher (0.2 times the HDD); and a host of behavioral abnormalities in the offspring of rats, including altered responsiveness to opioids at 4 mg/kg/day (0.7 times the HDD) or greater.

Fetal and/or postnatal exposure to morphine in mice and rats has been shown to result in morphological changes in fetal and neonatal brain and neuronal cell loss, alteration of a number of neurotransmitter and neuromodulator systems, including opioid and non-opioid systems, and impairment in various learning and memory tests that appear to persist into adulthood. These studies were conducted with morphine treatment usually in the range of 4 to 20 mg/kg/day (0.7 to 3.2 times the HDD).

Additionally, delayed sexual maturation and decreased sexual behaviors in female offspring at 20 mg/kg/day (3.2 times the HDD), and decreased plasma and testicular levels of luteinizing hormone and testosterone, decreased testes weights, seminiferous tubule shrinkage, germinal cell aplasia, and decreased spermatogenesis in male offspring were also observed at 20 mg/kg/day (3.2 times the HDD). Decreased litter size and viability were observed in the offspring of male rats that were intraperitoneally administered morphine sulfate for 1 day prior to mating at 25 mg/kg/day (4.1 times the HDD) and mated to untreated females. Decreased viability and body weight and/or movement deficits in both first and second

Clinical Impact: Intervention:

The concomitant use of anticholinergic drugs may increase 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 MORPHABOND ER is used concomitantly with anticholinergic drugs.

P-Glycoprotein (P-gp) Inhibitors

Clinical Impact:

The concomitant use of P-gp-inhibitors can increase the exposure to morphine by about two-fold and can increase risk of hypotension, respiratory depression, profound sedation, coma, and death.

Intervention:

Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of MORPHABOND ER and/or the P-gp-inhibitor as necessary.

Example:

quinidine

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. There are no available data with MORPHABOND ER in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see Human Data].

In published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (HDD) in hamsters and mice, respectively, lower fetal body weight and increased incidence of abortion at 0.4 times the HDD in the rabbit, growth retardation at 6 times the HDD in the rat, and axial skeletal fusion and cryptorchidism at 16 times the HDD in the mouse. Administration of morphine sulfate to pregnant rats during organogenesis and through lactation resulted in cyanosis, hypothermia, decreased brain weights, pup mortality, decreased pup body weights, and adverse effects on reproductive tissues at 3-4 times the HDD; and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the HDD [see Animal Data].

Based on animal data, advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

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. 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. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4)].

Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. MORPHABOND ER is not recommended for use in women during and immediately prior to labor, when shorter acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including MORPHABOND ER, 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. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

generation offspring were reported when male mice were treated for 5 days with escalating doses of 120 to 240 mg/kg/day morphine sulfate (9.7 to 19.5 times the HDD) or when female mice treated with escalating doses of 60 to 240 mg/kg/day (4.9 to 19.5 times the HDD) followed by a 5-day treatment-free recovery period prior to mating. Similar multigenerational findings were also seen in female rats pre-gestationally treated with escalating doses of 10 to 22 mg/kg/day morphine (1.6 to 3.6 times the HDD).

8.2 Lactation Risk Summary Morphine is present in breast milk. Published lactation studies report variable concentrations of morphine in breast milk with administration of immediate-release morphine to nursing mothers in the early postpartum period with a milk-to-plasma morphine AUC ratio of 2.5:1 measured in one lactation study. However, there is insufficient information to determine the effects of morphine on the breastfed infant and the effects of morphine on milk production. Lactation studies have not been conducted with extendedrelease morphine, including MORPHABOND ER. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with MORPHABOND ER. Clinical Considerations Monitor infants exposed to MORPHABOND ER through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of morphine is stopped, or when breastfeeding is stopped.

8.3 Females and Males of Reproductive Potential Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2), Clinical Pharmacology (12.2) in the full prescribing information].

In published animal studies, morphine administration adversely effected fertility and reproductive endpoints in male rats and prolonged estrus cycle in female rats [see Nonclinical Toxicology (13) in the full prescribing information].

8.4 Pediatric Use The safety and effectiveness in pediatric patients below the age of 18 have not been established.

8.5 Geriatric Use The pharmacokinetics of MORPHABOND ER have not been studied in elderly patients. Clinical studies of morphine sulfate extended-release did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Elderly patients (aged 65 years or older) may have increased sensitivity to morphine. In general, dosage selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of MORPHABOND ER slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.6)].

Morphine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6 Hepatic Impairment Morphine pharmacokinetics have been reported to be significantly altered in patients with cirrhosis. Start these patients with a lower than usual dosage of MORPHABOND ER and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3) in the full prescribing information].

8.7 Renal Impairment Morphine pharmacokinetics are altered in patients with renal failure. Start these patients with a lower than usual dosage of MORPHABOND ER and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3) in the full prescribing information].

9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance MORPHABOND ER contains morphine, a Schedule II controlled substance.

9.2 Abuse MORPHABOND ER contains morphine, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, oxycodone, oxymorphone, and tapentadol.

MORPHABOND ER can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.1)].

The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse.

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.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.

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 in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other healthcare provider(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. Healthcare providers 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.

MORPHABOND 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 state and federal 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 limit abuse of opioid drugs.

Risks Specific to Abuse of MORPHABOND ER MORPHABOND ER is for oral use only. Abuse of MORPHABOND ER poses a risk of overdose and death. This risk is increased with concurrent abuse of MORPHABOND ER with alcohol and other central nervous system depressants. Taking cut, broken, chewed, crushed, or dissolved MORPHABOND ER enhances drug release and increases the risk of overdose and death.

Parenteral abuse of MORPHABOND ER can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Abuse Deterrence Studies MORPHABOND ER is formulated with inactive ingredients that make the tablet more difficult to adulterate for misuse and abuse while maintaining extended-release characteristics even if the tablet is subjected to physical manipulation, and/or chemical extraction. To evaluate the ability of the abuse-deterrent technology to reduce the potential for abuse of MORPHABOND ER, a series of in vitro laboratory manipulation, extraction, and syringeability, studies was conducted. An in vivo clinical abuse potential study was also conducted. The results of these studies are summarized below. Overall, the results indicate that MORPHABOND ER has properties that are expected to reduce abuse or misuse via injection or insufflation; however, abuse by these routes is still possible.

In Vitro Testing MORPHABOND ER has been tested in vitro using methods of manipulation that drug abusers commonly use for preparation of extended-release opioids for administration by various routes, including oral consumption, intranasal insufflation, injection, and smoking.

Abusers may manipulate extended-release opioids in order to prepare the tablets for oral, intranasal, or intravenous administration. The laboratory test data demonstrated that, relative to morphine sulfate extended-release tablet, MORPHABOND ER has increased resistance to cutting, crushing, or breaking using a variety of tools. When subjected to a liquid environment the manipulated MORPHABOND ER formulation forms a viscous material that resists passage through a needle.

Clinical Studies A randomized, double-blind, double-dummy, placebo-controlled, singledose four-way crossover study in 25 non-dependent recreational opioid users with a history of intranasal drug abuse was performed to determine the relative bioavailability and abuse potential of crushed intranasal MORPHABOND ER 60 mg tablets compared with crushed intranasal morphine sulfate extended-release tablet 60 mg tablets, and intact orally administered MORPHABOND ER 60 mg tablets. The intact oral tablets were included as a reference for evaluating abuse potential after manipulation and administration via an unintended route.

Drug liking was measured on a 100 mm bipolar visual analog scale (VAS) where 50 represents a neutral response of neither liking nor disliking, 0 represents maximum disliking, and 100 represents maximum liking.

Response to whether the subject would take the study drug again was also measured on a bipolar scale of 0 to 100 where 50 represents a neutral response, 0 represents the strongest negative response (‘definitely would not take drug again’) and 100 represents the strongest positive response (‘definitely would take drug again’).

Intranasal administration of crushed MORPHABOND ER was associated with statistically significantly lower drug liking (Emax) scores (P < 0.0001), and significantly lower willingness to take the drug again (Emax) scores (P = 0.034), compared to crushed extended-release morphine (Table 2). Drug liking and take drug again scores for crushed intranasal MORPHABOND ER were not significantly different from those of MORPHABOND ER taken orally intact.

These data are consistent with the similar relative bioavailability after crushed intranasal and intact oral administration of MORPHABOND ER that support retention of its extended release properties when manipulated compared to morphine sulfate extended-release tablets [see Clinical Pharmacology (12.3) in the full prescribing information].

Table 2. Summary of Maximum Drug Liking (Emax) and Take Drug Again (Emax) Following Administration of MORPHABOND ER, morphine sulfate extended-release tablet, and Placebo in Recreational Opioid Users (n=25) Crushed Intranasal morphine sulfate Crushed extended-release Intranasal tablet vs. Crushed morphine Intranasal sulfate MORPHABOND ER Crushed Intranasal extendedDifference of MORPHABOND ER release LS Means 60 mg tablet 60 mg Placebo (95% CI) Drug Liking Mean (Emax) (SEM) Median (Range) Take Drug Mean Again (Emax) (SEM) Median (Range)

71.7 (2.87)

85.3 (2.42)

54.3 (1.63)

72 (50-100)

85 (56-100)

51 (50-80)

66.4 (3.76)

76.4 (4.17)

49.1 (2.21)

64.0 (38-100)

75.0 (17-100)

50.0 (0-64)

13.65 (7.80, 19.51)

9.96 (0.77, 19.14)

Figure 1 demonstrates a comparison of peak drug liking scores for crushed MORPHABOND ER compared to crushed extended-release morphine in subjects who received both treatments intranasally. Seventy-six percent of subjects (n = 19) experienced some reduction in Emax of Drug Liking VAS with crushed MORPHABOND ER compared with crushed extended-release morphine, 48%; (n = 12) experienced at least a 30% reduction in Emax and 32% (n = 8) experienced at least a 50% reduction in Emax of drug liking.

Percent of Subjects (%)

Figure 1. Percent Reduction Profiles for Emax of Drug Liking for MORPHABOND ER vs. Morphine Sulfate ER Tablets (n=25), Following Intranasal Administration 100 90 80 70 60 50 40 30 20 10 0 Percent Reduc�on in Emax (%)

Summary The in vitro data demonstrate that MORPHABOND ER has physiochemical properties expected to make abuse via injection difficult. The data from the clinical study, along with support from in vitro data, also indicate that

MORPHABOND ER has physicochemical properties that are expected to reduce abuse by the intranasal route of administration. However, abuse by intranasal, intravenous, and oral routes is still possible.

Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of MORPHABOND ER on the abuse liability of the drug. Accordingly, this section may be updated in the future as appropriate.

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 dosage 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 (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.

MORPHABOND ER should not be abruptly discontinued [see Dosage and Administration (2.5) in the full prescribing information]. If MORPHABOND ER is abruptly discontinued in a physically-dependent patient, a withdrawal 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 signs [see Use in Specific Populations (8.1)].

10 OVERDOSAGE Clinical Presentation Acute overdosage with MORPHABOND ER can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) in the full prescribing information].

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.

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to morphine overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose.

Because the duration of reversal would be expected to be less than the duration of action of morphine in MORPHABOND ER, carefully monitor the patient until spontaneous respiration is reliably reestablished.

MORPHABOND ER will continue to release morphine and add to the morphine load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced 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, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

Healthcare professionals can telephone Daiichi Sankyo, Inc. (1-877-437-7763) for information on this product.

Manufactured for: Daiichi Sankyo, Inc. Basking Ridge, NJ 07920 ©2017, Daiichi Sankyo, Inc. USPI-MOR-0918-r103-B

Education moves forward. www.painweek.org

eXeCUTiVe eDiTOR KEViN L. ZACHAROFF md, facpe, facip, faap

eeK

PUBLiSHeR PAINW

ART DiReCTOR DARRYL FOSSA

eDiTORiAL DiReCTOR DeBRA WeiNeR eDiTOR HOLLY CASTeR

Charles E. Argoff md, cpe Professor of Neurology Albany Medical College Department of Neurology Director Comprehensive Pain Center Albany Medical Center Department of Neurology Albany, ny Paul Arnstein rn, phd, acns-bc, fnp-c, faan Clinical Nurse Specialist for Pain Relief Massachusetts General Hospital Boston, ma Said R. Beydoun md, faan Professor of Neurology Director of the Neuromuscular Program Keck Medical Center of University of Southern California Los Angeles, ca Jennifer Bolen jd Founder Legal Side of Pain Knoxville, tn Paul J. Christo md, mba Associate Professor Johns Hopkins University School of Medicine Department of Anesthesiology and Critical Care Medicine Baltimore, md Michael R. Clark MD mph, mba Vice Chair, Clinical Affairs Johns Hopkins University School of Medicine Department of Psychiatry and Behavioral Sciences Director, Pain Treatment Programs Johns Hopkins Medical Institutions Department of Psychiatry and Behavioral Sciences Baltimore, md Geralyn Datz phd Affiliate University of Southern Mississippi Department of Psychology Clinical Director Southern Behavioral Medicine Associates Hattiesburg, ms

eDiTORiAL BOARD

Peter A. Foreman dds, daapm Consultant Rotorua Hospital and Private Practice Rotorua, New Zealand Gary W. Jay md, faapm, facfei Clinical Professor Department of Neurology Division: Headache University of North Carolina Chapel Hill, nc Mary Lynn McPherson pharmd, bcps, cpe, faspe Professor and Vice Chair University of Maryland School of Pharmacy Department of Pharmacy Practice and Science Hospice Consultant Pharmacist Baltimore, md Srinivas Nalamachu md Clinical Assistant Professor Kansas University Medical Center Department of Rehabilitation Medicine Kansas City, ks President and Medical Director International Clinical Research Institute Overland Park, ks Bruce D. Nicholson md Clinical Associate Professor Department of Anesthesia Penn State College of Medicine Hershey Medical Center Hershey, pa Director of Pain Specialists Lehigh Valley Health Network Department of Anesthesiology Allentown, pa

Marco Pappagallo md Director of Medical Intelligence Grünenthal usa Bedminster, nj Director Pain Management & Medical Mentoring New Medical Home for Chronic Pain New York, ny Steven D. Passik phd VP, Scientific Affairs, Education, and Policy Collegium Pharmaceuticals, Inc. Canton, ma Joseph V. Pergolizzi md Chief Operating Officer nema Research Inc. Naples, fl Robert W. Rothrock pa-c, mpa University of Pennsylvania Department of Anesthesiology and Critical Care Pain Medicine Division Philadelphia, pa Michael E. Schatman phd, cpe, daspe Editor-in-Chief Journal of Pain Research Adjunct Clinical Assistant Professor Tufts University School of Medicine Department of Health & Community Medicine Boston, ma Sanford M. Silverman md, pa CEO and Medical Director Comprehensive Pain Medicine Pompano Beach, fl Thomas B. Strouse md Medical Director Stewart and Lynda Resnick Neuropsychiatric Hospital at ucla Los Angeles, ca

Copyright © 2019, PAINWeek, a division of Tarsus Medical Group.

The opinions stated in the enclosed printed materials are those of the authors and do not necessarily represent the opinions of PAINWeek or its publication staff.

PAINWeek does not give guarantees or any other representation that the printed material contained herein is valid, reliable, or accurate. PAINWeek does not assume any responsibility for injury arising from any use or misuse of the printed materials contained herein. The printed materials contained herein are 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.

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vol. 7 q2 2019

20 30 38 46 56 61 62 63 64 68

behavioral

opioid deprescribing discussions: using MI without having an MI

by eleni romano allison schroeder

pharmacotherapy

spuds, screenings & safety: from chips to opioids

by mark garofoli

key topic

the carrot vs. the stick: value based interdisciplinary treatment

by corinne cooley heather king

music therapy

breaking the waves: medical music psychotherapy in the treatment of pain

by john f. mondanaro

op-ed

behind the wire: substance abuse and pain management

by jeffrey d. pomerantz

pw next generation

with jessica geiger-hayes

clinical pearls

by doug gourlay

pain by numbers one-minute clinician

with annas aljassem, levi hall, jennifer bolen, emily bartley, kimberly sibille, michael clark, robert raffa

pundit profile

with gary w. jay

PaiNWeeK 2019 Conference Preview P.69 14

PWJ | www.painweek.org

Q 2 | 2019

The national conference on pain for frontline practitioners.

The national conference on pain for frontline practitioners.

2019 2019

S 7 —7 Se ePT PTe eMB MBe eRR 33—

Global Education Group (Global) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education to physicians. Global Education Group designates Global Education Group (Global) is accredited by the Accreditation Council for Continuing Medical this live activity for a minimum of 39.0 AMA PRA Category 1 Credit(s)™. This activity will be approved Education to provide continuing medical education to physicians. Global Education Group designates for continuing pharmacy, psychology, nurse practitioner, nursing, and dentistry education. Applications this live activity for a minimum of 39.0 AMA PRA Category 1 Credit(s)™. This activity will be approved for certification of social work NASW and family physician AAFP hours will be applied for. For more for continuing pharmacy, psychology, nurse practitioner, nursing, and dentistry education. Applications information and complete CME/CE accreditation details, visit our website at www.painweek.org. for certification of social work NASW and family physician AAFP hours will be applied for. For more information and complete CME/CE accreditation details, visit our website at www.painweek.org.

MaNY PeOPLe

are not well versed in the role of using a biopsychosocial approach to treating patients I respect and consider to be much smarter Kevin L. Zacharoff with chronic pain, you have a lot to gain by than me have uttered the following words reading this piece. in the context of safe and effective pain management: “How do we know that education makes a difference?” As someone who has devoted the better part of 15 years to pain education, I have mentioned this in my lectures many times, but it bears repeating: my response has not changed—“If education doesn’t make a difference, Even though the likelihood of pharmacologic therapy being a component then isn’t everything lost? We must continue to educate healthcare profes- of a chronic pain treatment plan is virtually 100%, a successful treatment sionals about pain and its management, especially those in training, along outcome will require much more than medications. Nonpharmacologic with patients, caregivers, and regulators.” With all the media hype, we approaches to help patients negotiate the balance of pain and suffering might falsely assume that people already know about available opioid risk are important “tools in our toolbox.” John F. Mondanaro makes a very good screening tools, the value of complementary and alternative treatments, case about the role of medical music therapy in the treatment of chronic the importance of using biopsychosocial approaches in managing chronic pain. The significant amount of research gives a variety of scientific ratiopain, and the needs of disparate patient populations. PWJ covers all those nales that make a compelling case for the value of at least considering it topics and I hope you find something in this issue you didn’t know—and as part of a chronic pain treatment plan for appropriate patients. Few of I’m betting you will—because that’s education. us would argue that at one time or another music has helped us feel better.

Is it so innovative that it might help chronic patients also feel better?

Our first article by Drs. Eleni Romano and Allison Schroeder provides valuable information about potential ways that we can improve the quality of Gary W. Jay is featured in this issue’s Pundit Profile and to be completely medical interviews with patients through motivational interviewing. With honest, he is a dear friend and respected colleague, so I am biased. In my detailed explanations and case examples, the authors give us reason to opinion, Dr. Jay is the true Harry Chapin of the pain community, and never pause and possibly re-evaluate our current interviewing practices and skills ceases to amaze me with his storytelling capabilities and how he uses to see if we may be able to do more than just gather a history. If we consider those stories to help him teach others. It comes as no surprise that he the fact that context is equally as important as the chief pain complaint, is fascinated by the brain, because he is brainy. Opinionated, passionate, we may come that much closer to arriving at a treatment outcome that highly intelligent, and a master of headache treatment, he truly is someone realistically approximates the patient’s needs, goals, and expectations if willing to “do whatever he has to do” for the sake of the patient. we can understand the contextual narrative. This is part of most healthcare training curricula for valid reasons, and can potentially significantly improve Jessica Geiger-Hayes is the focus of this issue’s Next Generation. Five the care you provide, along with patient satisfaction. words should give enough reasons to read about her: pain management and palliative care. As someone who is willing to do a little bit of everything There are many available tools to assess the likelihood of a patient being to further patient care, she truly enjoys unlocking the door and helping to considered for or already being treated with opioid analgesics portraying make patients open up and feel comfortable. As I get older, I worry about an aberrant drug related behavior. Guidelines like the one issued by the cdc who will “carry the torch” for pain management in the future. When I think recommend using these tools, but it might not be so easy for clinicians about people like Jessica, I feel truly encouraged. on the frontline to find them or decide which one(s) is/are most valuable to their particular practice setting. Dr. Mark Garofoli does a wonderful So, there you have it: another issue of PWJ with a little bit of something job of providing a detailed description of these tools and their potential for everyone from a variety of disciplines. One thing I would very much value in clinical practice along with a comprehensive history, a physical, and like to see happen is that you share an article or two with someone who other strategies. If you have been looking for a summary of the opioid risk might benefit from the knowledge; after all, that is education. On that screening tools available, this is it, and you should keep it handy for future note, please look for a new recurring segment beginning in our next issue, reference and to share with colleagues. called Back to the Basics. These articles will be geared towards readers who are interested in foundational topics, sort of where it all begins when Corinne Cooley and Dr. Heather King focus on an important and timely managing acute and chronic pain. It is reasonable to think that there are subject in today’s chronic pain climate: values-based interdisciplinary many who are looking for pain education at its most basic level for a place treatments. All too often, we may try to “plug” patients into reductionis- to start, and that will be the intention of this segment. After all, pain tic treatment plans that work best with acute pain but typically fall short education must start somewhere. when managing patients with chronic pain. The authors remind us that the combination of psychological, physical, and medical treatment is likely to give the patient the best chance of a successful outcome. This article Kevin L. Zacharoff MD, FACIP, FACPE, FAAP shows us an example of an intervention used with patients with chronic low back pain. It is important to remember that often the optimal goal may seem to be avoiding pain, when in actuality it should really be about Kevin L. Zacharoff is Faculty and Clinical Instructor at suny Stony Brook School improving the value and quality of life. I don’t think many of us would say of Medicine in New York, and is Ethics Committee Chair at St Catherine of Siena that medications alone are likely to help patients achieve those goals. If you Medical Center in Smithtown, New York.

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Q 2 | 2019

PaiNWeeKeNDâ&#x201E;¢ ReGiONaL CONFeReNCe SeRieS

2019 visit www.painweekend.org for more information. aNaHeiM CA aTLaNTa GA aUSTiN TX BaLTiMORe MD BiRMiNGHaM AL BUFFaLO NY CHaRLeSTON SC CHaRLOTTe NC CHiCaGO IL

CLeVeLaND OH

MORRiSTOWN NJ

SaN DieGO CA

NeW ORLeaNS LA

SCOTTSDaLe AZ

DaLLaS TX

NaSHViLLe TN

HOUSTON TX

PHiLaDeLPHia PA

DeNVeR CO

iNDiaNaPOLiS IN JaCKSONViLLe FL LOS aNGeLeS CA

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MORGaNTOWN WVA

PROViDeNCe RI

RaLeiGH-DURHaM NC RiCHMOND VA

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SOUTHFieLD MI

ST. LOUiS MO

TaMPa FL

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Mark Garofoli pharmd, MBA, BCGP, CPE

p.30

Mark Garofoli is a Clinical Assistant Professor and Director of Experiential Learning for the West Virginia University (WVU) School of Pharmacy, along with being a Clinical Pain Management Pharmacist at the WVU Medicine Center for Integrative Pain Management. He is board certified in Geriatric Care and is a certified pain educator. Dr. Garofoli coordinated the development of the West Virginia Safe & Effective Management of Pain (SEMP) Guidelines (www.sempguidelines.org).

Heather King phd

p.38

Heather King is a pain psychologist, clinical assistant professor, and pain psychology fellowship director at the Stanford Pain Management Center, Division of Pain Medicine, Redwood City, California. She specializes in the development of novel chronic pain interdisciplinary treatment pathways. She coauthored her article with Corrine Cooley, a Physical Therapist Level III at the Stanford Pain Management Center, Orthopedic & Sports Rehabilitation, Chronic Pain Physical Therapy, in Redwood City, California.

John F. Mondanaro MA, LCAT, MT-BC, CCLS

p.46

John Mondanaro is the Clinical Director of the Louis Armstrong Music Therapy Department at Mount Sinai Beth Israel in New York, where he oversees inpatient services and clinical training. Currently a PhD candidate in Music Therapy, he is licensed as a Creative Arts Therapist in New York, maintains dual certification in Music Therapy and Child Life Practice, and is a published musician and author, presenter, professor, and most recently coeditor of the book Music and Medicine: Integrative Models in the Treatment of Pain.

Eleni M. Romano phd

p.20

Eleni Romano is a Clinical Psychologist and the Health Behavior Coordinator at the Eastern Colorado Health Care System in Denver. She coauthored her article with Allison E. Schroeder, pharmd, BCPS, a Clinical Pharmacy Specialist in chronic pain management also at the Eastern Colorado Heath Care System in Denver.

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PWJ | www.painweek.org

Q 2 | 2019

home with youâ&#x20AC;&#x201D;

By Eleni Romano phd / Allison Schroeder pharmd BCPS

By Eleni Romano phd / Allison Schroeder pharmd BCPS

behavioral

Abstract

Motivational interviewing (MI) is an evidenced based intervention and collaborative style of communication.

The MI style of communication can be helpful for resolving ambivalence, strengthening motivation for change, and increasing personal commitment to change.

In patients for whom opioid deprescribing is clinically indicated, MI can foster an environment of collaboration, participation in treatment planning, and movement toward shared goals. MI helps support engagement in a treatment plan, protects the therapeutic alliance, and improves patient and provider satisfaction. This article provides a brief overview of MI and concrete examples of how MI can be applied to opioid deprescribing conversations.

22 PWJ | www.painweek.org

Q 2 | 2019

With motivational interviewing, the thoughts, feelings, preferences, and decisions of the patient are fully respected, and the provider accepts the patient as they are, regardless of whether the provider agrees or disagrees with the patient’s beliefs and actions.

Mr. Smith is a 56-year-old patient with obesity, chronic low back pain and bilateral knee pain, obstructive sleep apnea, alcohol use disorder in remission, and major depressive disorder in partial remission. He presented to his primary care provider (PCP) for a transfer of treatment after being discharged from a pain clinic for “several opioid contract violations,” including multiple early refill requests and receiving a driving-under-the-influence charge following overuse of opioid medication. He is prescribed oxycodone sustained action (SA) 10 mg every 8 hours and oxycodone immediate release (IR) 5 mg 4 times per day as needed.

The discussion of medication dose changes between Mr. Smith and his PCP started poorly, as illustrated below:

PROVIDER: Mr. Smith, thank you for making it in today. It looks like things haven’t been going all that well with your opioid medications. It’s time to start tapering your opioids, since you haven’t been able to use them safely.

MR. SMITH: But the problem is not that I’m not safe to take my medications, it’s that my pain has been out of control. I don’t need less medication, I need more.

PROVIDER: Well, the fact that you’ve been taking more than you were prescribed and getting in trouble with the law is evidence that it’s time to start reducing your dose. We have other options for pain management that we should talk about.

MR. SMITH: Everyone keeps nagging me about how I’m taking my medications: my daughter, my wife, my pain doc, and now you. No one seems to get it. My pain is the real problem, not my medications. Sure, I don’t want to take them for the rest of my life, but I must get the pain under control before making any changes. If I come off my meds now, my pain is going to be so unbearable I won’t be able to function.

Q 2 | 2019

Medical providers are taught to make medication changes from day 1 and do so daily as part of routine clinical practice. Yet, not all medication changes are created equal. For providers, discussing discontinuation of a beta blocker feels different than an opioid.

While providers are usually confident in the decision to start an opioid taper based on clinical rationale, initiating the conversation to taper opioids is often met with uncertainty, discomfort, and avoidance. Consistently, medical residents and fellows report that they are undertrained in opioid prescribing practices, assessing for problematic behaviors associated with opioids, and managing tapers.1-3 The discomfort surrounding opioid management also affects hospitalist providers in inpatient medicine settings,4 which suggests there is a widespread void in confident opioid management across settings and levels of experience. When providers feel uncomfortable or undertrained in the area of complex pain management, discussing concerns with patients seems daunting even with increasing public awareness, substantial clinical backing, and guidelines in support of their efforts.

In addition to provider discomfort, a discussion about opioid reduction can feel heavy-handed if the patient disagrees with the clinical assessment. When disagreement with the decision occurs, providers may try to argue for change by rearticulating the level of escalating risk based on the assumption that providing that information, giving insight into complications, and/or offering skills to mitigate risk will motivate a person to change. Despite detailed, lengthy discussions about the necessity to decrease opioid doses when clinically indicated, patients may continue to disagree with the provider’s assessment and plan. Patients may believe their preferences and concerns are not being taken into consideration and providers may experience frustration that their patient has not “bought in” to a plan that logically appears to make clinical sense. This back and forth contributes to mutual frustration and dismissal between patients and providers and disrupts the therapeutic alliance.5 The “push-pull” interaction style often experienced in opioid dose reduction conversations has consequences beyond disruption in the therapeutic relationship. It is also a missed opportunity to join with and engage patients in change, something that can be accomplished through the use of a simplistic, yet difficult to execute fundamental notion of communication: to support the process of change, it is not necessarily what we communicate, but how we communicate. www.painweek.org | PWJ

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behavioral

What is Motivational Interviewing?

Motivational interviewing (MI) is a style of communication well suited for opioid taper discussions. MI is a “collaborative conversation style for strengthening a person’s own motivation and commitment to change.”6 It is rooted in psychological theories of change that suggest when a person argues on behalf of change, that person is more likely to change.7 (A simple, nonmedical example: if a parent says to their child, “Clean your room. Aren’t you embarrassed how it looks?” the child might say, “I don’t care. It doesn’t bother me.” The child is arguing to not clean their room. But a different example would be a parent saying, “Your cousins are coming over. How would you like them to see your room?” The child might respond, “Oh, I don’t want them to see my room like this.” The child is then more likely to clean their room.) MI strengthens interest in health behavior change by highlighting and helping resolve discrepancies between behavior and values; for example, a patient who values spending time with his grandchildren but is too somnolent and fatigued when he has taken his opioid dose. With regard to opioid deprescribing, the patient, rather than the provider, argues for the side of opioid dose reduction by being prompted to describe their own reasons for change, the importance of making a change, concerns about continuing on the current path, and confidence in successfully reducing opioid doses.6,8 For providers, MI increases comfort in guiding difficult conversations, supports maintenance of rapport despite discussions of topics that have the potential to undermine the patientprovider relationship, maintains a patient-centered approach, and has the potential to decrease frustration and burnout. For patients, patient-centered communication methods such as MI can improve satisfaction with care, recall of health related discussions, and follow-through with health related behavior change.9 MI has been shown to be effective with many presenting problems, which include increasing use of self-management strategies for chronic pain,10 medication adherence,11 appropriate opioid use,12 weight loss, blood pressure management, substance use disorders,13 diabetes management,14 and smoking cessation.15 In addition, MI is an effective tool used in multiple settings (eg, primary care, substance use disorder clinics) and with providers from a variety of disciplines (eg, psychologists, nurses, physicians).

The “Spirit” and Key Principle of Motivational Interviewing The MI learning process begins with providers embodying the “spirit” of MI and understanding the key principles of MI. The spirit of MI involves 4 key components: partnership, acceptance, compassion, and evocation.6,8 The patient-provider interaction represents a collaborative effort that can be viewed as a partnership. While healthcare providers may have developed expertise in treating certain conditions, patients are experts on their own lives, exercising choice and control in how they live their lives. With MI, the thoughts, feelings, preferences, and decisions of the patient are fully respected, and the provider

24 PWJ | www.painweek.org

accepts the patient as they are, regardless of whether the provider agrees or disagrees with the patient’s beliefs and actions.

Motivation to change is elicited (or evoked) from the patient when the provider uses specific skills and strategies. MI is based on the principle that patients are more likely to participate in the change process when providers resist the urge to correct or lecture patients about their behavior or beliefs in confrontational or directive ways, seek to understand patients’ values and motivation for change with empathy, and empower patients to make changes in their lives by building confidence. 6 Clinicians should remain nonjudgmental about a patient’s choices and how they wish to live their lives.

Motivation vs Ambivalence Motivation for change is often assumed to be a binary phenomenon: people are either motivated or unmotivated, which is an all too reductive perspective. In fact, most people are ambivalent about change, even if the reasons seem compelling to an outside observer.8 People see both reasons to change and reasons to stay the same—they simultaneously want to change and do not want change. Feeling stuck reflects a very natural human process and is ubiquitous when broaching the topic of opioid reduction. Healthcare providers are most likely to hear the reasons to maintain or increase opioid doses, although many patients are deeply ambivalent about their opioid medications.

This ambivalence is not surprising as opioids are associated with many potential issues, such as constipation, negative cognitive effects, limited long-term efficacy, and risks of overdose and death.16 Consider Mr. Jones who believes his opioids are no longer working to treat chronic pain and negatively affect the clarity of his thinking but is fearful of withdrawal. Or Ms. Harris, a machine operator who is concerned opioid medications are affecting her ability to perform her job safely but believes her pain will render her unable to work if she stops taking them. An MI approach helps people resolve ambivalence by intentionally drawing out talk in the direction of change (“change talk”) rather than eliciting talk on the side of staying the same (“sustain talk”).7

MR. JONES Change talk: opioids have decreased effectiveness and are negatively impacting thinking clarity Sustain talk: fearful of withdrawal MS. HARRIS Change talk: opioids are negatively affecting her safety and work performance Sustain talk: believes opioid taper will cause uncontrolled pain and render her unable to work Q 2 | 2019

Table 1. Examples of OARS

Open Ended Questions ○○ What concerns do you have about your opioid medications? ○○ How have your medications been getting in the way of your values and quality of life? ○○ How has the effectiveness of your medications changed over time? ○○ You have said in the past you are concerned about the side effects of the oxycodone and how it might affect your relationship with your family. Tell me more about that. ○○ How important is it for you to make a change with your current medications?

Affirmations ○○ You have worked really hard to make important changes in your life, like when you quit smoking and drinking alcohol. ○○ Despite having a bad pain week, you managed to go to your daughter’s softball game. I imagine that wasn’t easy. ○○ The fact you showed up today despite your busy schedule really shows your commitment.

Reflections ○○ You’re frustrated that these medications work less and less, and you still have the side effects. ○○ Everyone in your family has said they think you should stop taking opioids because of the effects they see, like you falling asleep at dinner last week. You aren’t sure, but it makes you think twice about staying on them. ○○ On the one hand, you want to increase your dose of opioids, and on the other hand you are concerned when you hear stories in the news about how opioids are dangerous. ○○ You have tried to stay on track with your pain meds, and yet it has been hard not to take a few more tabs every day. This doesn’t feel sustainable.

Summaries ○○ I’d like to summarize to make sure I am getting this all right. Your pain seems to have been getting worse despite getting on more medications. On the one hand, you would like an increase in your methadone; on the other hand, you notice it making you feel sleepy and unmotivated during the day. Your wife doesn’t like seeing you dependent on a medication and you worry about your doctor’s concerns about how it is affecting your heart. Where would you like to go from here?

OARS

Miller and Rollnick6 outlined a number of skills—open ended questions, affirmations, reflections, and summaries—that can be applied to help engage a patient in a discussion about opioid dose reduction:

1

Use of open ended questions, which cannot be answered with a “yes” or “no,” provide rich and valuable information about a person’s life, values, concerns, reasons for change, and perspective. These questions also signal to a person that the provider is eager to listen and understand.

2

Providing patients with affirmations in a genuine manner recognizes a patient’s efforts, strengths, and builds confidence in their ability to change.

3 Q 2 | 2019

Reflections by clinicians can also be valuable. These are efforts to reflect back to the patient what was heard or

stated (“simple” reflection) or reflect with adding feelings, a deeper meaning, or connection to values (“complex” reflection). Use of reflections moves the conversation toward a greater understanding of the situation and closer to resolution of ambivalence. They support the therapeutic relationship, create an atmosphere of nonjudgment and safe exploration of issues, and selectively draw out more talk in the direction of change.

4

Summaries are a selective summarization of a discussion with emphasis on change talk, which can help signal a shift in the conversation toward identifying a next step or plan of action.

When a clinician is aligned with the MI conversation style, more open ended questions will be used than closed ended questions, more reflections will be used than questions, and summaries can be used to transition to discussions of next steps. Examples of OARS can be found in Table 1. www.painweek.org | PWJ

25

behavioral

Table 2. Examples of DARN-CAT

Desire ○○ I want to get off these opioids because they aren’t doing me much good anymore. ○○ I’d like to start getting to the recreation center and using the pool.

Ability ○○ I quit smoking 10 years ago. Nothing, not even coming down on my meds, could be as hard as that. ○○ I’m stubborn. Once I decide I’m ready for a taper, I know I could do it.

Reasons ○○ If my employer finds out I take opioids, I could get in trouble—even fired. ○○ I just keep craving more and more. Sometimes, it’s all I think about. I’ve got to stop this.

Need ○○ I know that if I don’t stop using my mother’s hydrocodone with my oxycodone prescription, I am putting my life at risk. ○○ I need to figure out how to manage my pain without taking so much medication. I heard it is bad for my COPD and heart disease.

Commitment ○○ I’m going to get through this taper no matter what. ○○ I want to be walking as much as a mile a day before we go on vacation.

Activation ○○ I am ready to start moving forward with a taper next month. ○○ I researched different recreation centers in my area so I can start going to the pool.

Taking Steps ○○ Yesterday I had a bad pain day, and I surprised myself when I kept it to two prn tabs instead of my usual four. ○○ I’ve started to leave the key to the safe with my wife so I can avoid going back for more than I am prescribed.

DARN-CAT When “change talk” emerges in a discussion, use of OARS can be used to deepen and elaborate on what is heard in order to resolve ambivalence and guide the patient toward change. Clinicians can “tune in” to listening for change talk. This can sound like desire, ability, reasons, or need (DARN) for change. Additionally, statements of commitment to change, activation, and taking steps (CAT) can signal to a provider that a patient is increasingly ready to change. Examples of DARN-CATs are listed in Table 2.

In the example of Mr. Smith and his PCP, the original conversation can be shifted from push-pull to a collaborative discussion about change by using MI. The change talk is in bold, and the OARS used is listed after each provider statement.

PROVIDER: Mr. Smith, thank you for making it in today. From what I can see in the chart, things haven’t been going all that well with your opioid medications.

26 PWJ | www.painweek.org

I’ve had a chance to look at the notes from your pain doctor, but I’d like to hear your perspective.

How have things been going with your pain and pain medications?

[Open ended question] MR. SMITH: Everyone keeps nagging me about how I’m taking my medications: my daughter, my wife, and my pain doc. I don’t want to take my pain meds for the rest of my life, but I must get the pain under control before making any changes.

PROVIDER: It sounds like your pain has been difficult to manage, and people in your life, who care about you very much, are quite concerned about how much of your oxycodone you have been taking.

[Complex reflection] Q 2 | 2019

Motivational interviewing helps support engagement in a treatment plan, protects the therapeutic alliance, and improves patient and provider satisfaction.

MR. SMITH: My wife and daughter are worried I am going to overdose on my medications when I double up my dose. I don’t want to take more than I am supposed to, but sometimes the pain is just too unbearable.

They are making such a big deal of all this.

PROVIDER: Your wife and daughter are concerned about your safety, and that matters to you. What concerns do you have about your opioids and how you have been taking them?

[Complex reflection; open ended question] MR. SMITH: I mean, yeah. I especially don’t like running out of my medications and getting withdrawal for a week every month. I am constantly worried my medications are going to be taken away from me, and I have no idea how I am supposed to function if that happens. It is just taking over my life. My wife even threatened to leave when I got that DUI. PROVIDER: This has really been a tough road. You’re worried not just about your pain, but also your relationship.

[Complex reflection] MR. SMITH: It has been tough. I don’t see a way I can come off these medications, but I don’t like how they are taking over my life. I got sober in AA, and it feels like I’m messing with my recovery when I’m going through this with another addictive substance.

PROVIDER: You take your recovery very seriously, and you worked hard to get where you are with your sobriety from alcohol.

[Complex reflection; affirmation] Q 2 | 2019

MR. SMITH: I DID work really hard!

PROVIDER: I want to make sure I have this all right. Your pain hasn’t been well managed lately, and you have been taking more of your medications than were prescribed. This has led to several negative consequences, like getting a DUI, running out early and having withdrawal, and conflict with your family. You don’t like the road you are on right now and worry that opioids are messing with your recovery but are not sure how to get unstuck.

Where would you like to go from here?

[Reflections, summary, open ended question] MR. SMITH: I’d like to talk about how to manage my pain better, and maybe get more oxycodone. I don’t know.

Provider: Would it be all right if I shared some of my thoughts and concerns about opioids and information about other options for pain management? (asking permission to share information) MR. SMITH: Yeah, I’d be open to that.

Conclusion This article provides a brief introduction to MI, one communication style well suited for resolving ambivalence about opioid related medication changes for those for whom a taper may be indicated. MI is an evidence-based intervention that helps support collaboration and engagement in a treatment plan, protects the therapeutic alliance, and improves patient and provider satisfaction. While this article only provides a brief overview, numerous resources to help providers develop MI skills are available, several are listed on the following page. www.painweek.org | PWJ

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behavioral

Motivational Interviewing Resources ●● Motivational Interviewing Network of Trainers (MINT). Available at: motivationalinterviewing.org/. ●● Miller WR, Rollnick S. Motivational Interviewing: Helping People Change. 3rd ed.

New York, NY: The Guilford Press; 2013. ●● Rollnick S, Miller WR, Butler CC. Motivational Interviewing in Health Care: Helping Patients Change Behavior. New York, NY: The Guildford Press; 2008. ●● Douaihy A, Kelly TM, Gold MA, eds. Motivational Interviewing: A Guide for Medical Trainees. New York, NY: Oxford University Press; 2014. ●● Rosengren DB. Building Motivational Interviewing Skills: A Practitioner Workbook.

2nd ed. New York, NY: The Guilford Press; 2015.

References 1. Childers JW, Arnold RM. “I feel uncomfortable ‘calling a patient out’”: educational needs of palliative medicine fellows in managing opioid misuse. J Pain Symptom Manage. 2012;43(2):253–260.

2. Poon SJ, Greenwood-Ericksen MB. The opioid prescription epidemic and the role of emergency medicine. Ann Emerg Med. 2014;64:490–495.

3. Khidir H, Weiner SG. A call for better opioid prescribing training and education.

West J Emerg Med. 2016;17(6):686–689.

4. Calcaterra SL, Drabkin AD, Leslie SE, et al. The hospitalist perspective on opioid prescribing: a qualitative analysis. J Hosp Med. 2016;11(8):536–542.

5. Matthias MS, Krebs EE, Bergman AA, et al. Communicating about opioids for chronic pain: a qualitative study of patient attributions and the influence of the patient-physician relationship. Eur J Pain. 2014;18:835–843.

6. Miller WR, Rollnick S. Motivational Interviewing: Helping People Change. 3rd ed.

New York, NY: The Guilford Press; 2013 7. Miller WR, Rose GS. Toward a theory of motivational interviewing. Am Psychol.

2009;94(6):527–537.

8. Rollnick S, Miller WR, Butler CC. Motivational Interviewing in Health Care: Helping Patients Change Behavior. New York, NY: The Guildford Press; 2008.

9. King A, Hoppe RB. “Best practice” for patient-centered communication: a narrative review. J Grad Med Ed. 2013;5(3):385–393.

10. Dorflinger L, Kerns RD, Auerbach SM. Providers’ roles in enhancing patients’ adherence to pain self management. Transl Behav Med. 2013;3(1):39–46.

11. Palacio A, Garay D, Langer B, et al. Motivational Interviewing improves medication adherence: a systematic review and meta-analysis. J Gen Intern Med. 2016;31(8):929–940.

12. Chang Y, Compton P, Almeter P, et al. The effect of motivational interviewing on prescription opioid adherence among older adults with chronic pain. Perspect Psychiatr Care. 2015;51:211–219.

13. VanBuskirk KA, Loebach-Wetherell J. Motivational interviewing with primary care populations: a systematic review and meta-analysis. J Behav Med. 2014;37:768–780.

14. Phillips AS, Guarnaccia CA. Self-determination theory and motivational interviewing interventions for type 2 diabetes prevention and treatment: a systematic review. J Health Psychol. 2017:1–23.

15. Hettema JE, Hendricks PS. Motivational interviewing for smoking cessation: a meta-analytic review. J Consult Clin Psychol. 2010;78(6):868–884.

16. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain United States. MMWR Morb Mortal Wkly Rep. 2016;65(No. RR-1):1-49.

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By Mark Garofoli pharmd, MBA, BCGP, CPE

FROM CHiPS TO OPiOiDS

In a 1963 television commercial, actor Bert Lahr (the Cowardly Lion in The Wizard of Oz) was tempted by the devil holding a bag of Lay’s potato chips. “Betcha can’t eat just one,” said the devil. Lahr grabbed the bag out of the devil’s hand. The phrase became one of the longest lasting tag lines in American advertising.1 What can this potato chip advertisement possibly have to do with pain management and patient safety? If you’re looking at the forest within the trees, possibly a lot.

If a patient “can’t eat just one” potato chip, could he or she possibly be at a higher risk for opioid abuse or, for that matter, abuse of anything?

There would obviously need to be significant studies to prove such a thought; however, in the meantime, there are numerous proven opioid risk screening tools readily available for clinicians.

pharmacotherapy

The US Centers for Disease Control and Prevention (CDC)

recommend that opioid risk screenings be utilized for all patients under consideration for receiving opioid therapy and/or already receiving opioid therapy.2 A clinician must select an opioid risk screening tool to assess the patient’s potential for addiction, misuse, or abuse that may contribute to the possible effectiveness of the opioid therapy, even before beginning such a therapy. There are several opioid risk screenings available. The screenings included in this review are validated and have been included within multiple guidelines (see Table).

The first question a clinician needs to answer is whether the patient is opioid-naïve or opioid-experienced. Second, a clinician must decide whether the intention is for the patient to personally complete the screening or for the healthcare provider to conduct the screening.

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The consideration of whether to have a patient or a clinician complete an opioid risk screening involves many factors, such as time, clinician experience, clinician comfort level, trustworthiness of the patient, and suspected patient substances being utilized, just to name a few. Many clinicians prefer to conduct the risk screening personally; however, practically speaking, the valuable resource of time always factors in. In cases where the time is very limited, having a patient complete a paper/electronic form prior to an appointment or even while in the waiting room may suffice. What’s one more form, right? Additionally, the practitioner may want to consider if any opioid risk screenings have already been incorporated into his/her electronic health record system for ease of use and consistent documentation.

Regardless of who actually completes the opioid risk screening for any given patient scenario, one must also remember the intensity of some of the questions being asked, such as those regarding personal and/or family history of substance use disorder (ie, addiction), illicit drug use, and criminal actions.

Preferably a strong patient-provider relationship should be present prior to conducting an opioid risk screening, not to mention having a signed patient-provider agreement/contract.

(The FDA has provided examples of appropriate patient and provider agreements with good utility.3) Additionally, one could ask, “What better way to develop that strong patient-provider relationship than with such intense questions and conversation to begin with?”

Beyond incorporating any given office practice’s process, the advantages of having a patient complete the screening include the important concept of keeping the patient active within the healthcare decision process, resulting in patient centered care.

A relative disadvantage is the possible lack of verification of the reported screening results. Also, in many scenarios, a professional ultimately will end up eventually reviewing the screening results with the respective patient again anyway, which begs the question of whether to simply have the professional administer the screening in the first place.

Opioid-Naïve Patient Risk Screenings Self-screens For those patients who are opioid-naïve, and a clinician would prefer for the patient to complete an opioid risk screening on their own, both the Drug Abuse Screening Test (DAST) and then Screener & Opioid Assessment for Patients with Pain (SOAPP) are appropriate screening tools. The DAST was originally published in 1982 by Dr. Harvey Skinner and was modified from the Michigan Alcoholism Screening Test (MAST). The DAST is

Table. Opioid Therapy Risk Assessment Screening Tools For the Opioid-Naïve

For the Opioid-Experienced

Self-Reported

Self-Reported

▸▸Drug Abuse Screening Test (DAST)

▸▸Current Opioid Misuse Measure (COMM)

▸▸Screener & Opioid Assessment for Patients with Pain (SOAPP)

▸▸Pain Medication Questionnaire (PMQ)

▸▸Screening & Opioid Assessment for Patients with Pain-revised (SOAPP-r)

▸▸Prescription Drug Use Questionnaire for Patient Reporting (PDUQp)

Provider-Reported

Provider-Reported

▸▸Opioid Risk Tool (ORT)

▸▸Prescription Drug Use Questionnaire (PDUQ)

▸▸Opioid Risk Tool Updated (ORT-OUD) ▸▸Diagnosis, Intractability, Risk, & Efficacy Score (DIRE)

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Patient and provider agreements for pain management (±opioid therapy)… should always be utilized.

available in 3 versions varying in the number of questions within, including the DAST-28, DAST-20, and DAST-10, each being a successive update to the prior while reducing the question burden.

There is no great difference in validity nor utility amongst the 3 versions (nor the adolescent version DAST-A), other than the DAST-10 including the most recently revised question wording and least amount of questions. Scores greater than 12 on the DAST-28 tool indicate a definitive substance abuse problem.

Scores greater than 5 on the DAST-10 tool indicate a substantial/ severe level of drug abuse.4 The SOAPP was revised to be less susceptible to overt deception and is recognized as the SOAPP-r.

The SOAPP-r includes 24 questions with a 5-point scale, where scores greater than 18 indicate a high risk for opioid misuse.5 As for choosing either the DAST or the SOAPP, clinicians should remember that the most important effort is to do the screening in any manner, but when considering overall drug usage as compared to the targeted medication class of opioid medications and needing to ask fewer questions, the DAST is has more practical utility.

Provider screens For those patients who are opioid-naïve, and for who a clinician would prefer to conduct the opioid risk screening, both the

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Opioid Risk Tool (ORT) and the Diagnosis, Intractability, Risk, & Efficacy Score (DIRE) are appropriate screening tools. The ORT is one of the most widely accepted and utilized opioid risk screenings tools for its ease of use due to a concise short list of patient questions. The ORT includes 5 questions with overall scores ranging from 0 to 26. Scores from 4 to 7 are considered moderate risk; scores greater than 7 are considered high risk.6 The revised Opioid Risk Tool for Opioid Use Disorder (ORT-OUD) aims to discriminate between those patients with and without opioid use disorder (OUD), as opposed to the regular ORT only generally screening for opioid abuse. The ORT-OUD is a validated screening that essentially eliminates the question of a patient having a history of preadolescent sexual abuse from the original ORT screening.7 In addition to separating opioid use disorder from opioid abuse, the ORT-OUD eliminates the need for a clinician having to be comfortable asking a rather personal question.

The DIRE was developed after the Minnesota Board of Medicine took corrective action on one prescriber based on his concerning prescribing patterns. The healthcare community demanded to know who should or should not be on long-term opioids for chronic pain, and thus the DIRE was developed as a possible leg to stand on. While developing the DIRE, Dr. Miles Belgrade, a Q 2 | 2019

neurologist, showed both strong correlation to opioid compliance and showed moderate correction to opioid efficacy. Scores ranging from 7 to 13 indicate not being suitable for long-term opioid utilization, whereas scores ranging from 14 to 21 indicate a patient may be a candidate for long-term opioid utilization.8

Opioid-Experienced Patient Risk Screenings Self-screens More often than not, patients who have utilized opioid therapy for longer periods of time may fall through the cracks of care for being continually screened for risk of opioid abuse, due to multiple factors, but typically due to a repetitious nature of patient care. Life can change in an instant, let alone over the course of years or decades, thus patients deserve follow-up screenings for any psychological related issues, including the risk of opioid abuse. For those patients who are opioid experienced, and a clinician would prefer for the patient to complete an opioid risk screening on their own, the Current Opioid Misuse Measure (COMM), Pain Medication Questionnaire (PMQ), and the Prescription Drug Use Questionnaire for patient reporting (PDUQp) are appropriate screening tools. The COMM is widely accepted and utilized based on its high level of sensitivity and specificity. The COMM includes 17 questions on a 5-point scale with the aim of identifying patients who may be misusing opioid medications, which is suggested by a score greater than 8.9 The PMQ includes 26 questions on a 4-point scale, but does not have a recommended “cut-off” score that specifically identifies the level of risk for opioid abuse.10 The PDUQp was developed in 2008 as a redesign of the 1998 PDUQ, while taking both the COMM and the PMQ into consideration.

The PDUQp includes 31 questions, and although it includes a specific discussion on medication agreement violation-related discontinuation, does not include specific cut-off scoring as with the PMQ.11

Provider screens For those patients who are opioid experienced, and a clinician would prefer to conduct the opioid risk screening, the Prescription Drug Use Questionnaire (PDUQ) is an appropriate screening tool. The PDUQ includes 42 questions, with only 39 questions scored. The PDUQ, like the PDUQp and the PMQ, does not include any specific cut-off scoring for guidance on a high risk for opioid abuse, which may create a desire for a healthcare professional to utilize the COMM screening if that cut-off scoring system is desired.12 There are few truly distinguishing elements to demand the use of one specific opioid-experienced patient risk screening tool, beyond whether to choose an opioid risk screening completed by a patient or clinician. One additional consideration of practical use is that the PDUQ and PDUQp both utilize a simplified yes/no answering tally whereas the COMM and PMQ screenings utilize a 5-point scale allowing for more variability and specificity, if wanted.

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After the Assessment After determining the screening results, the next step is to determine an action plan for those patients who demonstrate a moderate or high risk of opioid abuse. There is no specific guidance that states a provider should universally avoid the utilization of opioid medications in these cases, yet clinicians should certainly proceed with caution in such instances. For a patient screening at a very high risk within an opioid risk screening, the decision on whether to utilize an opioid medication must be addressed by reviewing the “entire patient” in regard to the historical and current situation for that patient. For instance, if a patient had misused/abused any medication 20 years ago, and has been perfectly compliant since that time, the question of whether to avoid opioid medications outright in the present day may be distorted. Conversely, if a patient is currently diagnosed with multiple psychiatric medical conditions including opioid use disorder, and has had multiple recent opioid overdoses, the question of whether to utilize opioid medications within the overall treatment plan for that patient still exists as a question, but may be more easily answered for the sake of safety (ie, “do no harm”).

There are many other risk reduction strategies that should be universally incorporated into pain management patient care beyond repeated opioid risk screenings. Patient and provider agreements for pain management (±opioid therapy), as previously mentioned, should always be utilized. Yes, for documentation, but more importantly as conversation guides. More frequent monitoring of the Prescription Drug Monitoring Program (PDMP) database, and other tools such as clinical urine drug testing and abuse deterrent formulation opioid medications, are also all appropriate options.

Conclusions When opioid risk screenings are utilized in conjunction with an overall risk management plan, not only is patient care improved and patient risk minimized, but also the liability risk of the healthcare professional is subsequently reduced. This is the proverbial “win win” scenario and will not only reduce both patient and provider risk, but also improve the impact of every conversation with a patient, to extend well beyond “do no harm” into the realm of truly helping our patients live longer and healthier lives.

All risk reduction strategies become more impactful when utilized more frequently. At the bare minimum, opioid risk screenings should be conducted annually. Best practices typically mandate the usage quarterly (ie, every 3 months). In the practice of providing the best patient care possible, however, an opioid risk screening can be conducted at every office visit. This may not naturally flow into any office’s general workflow, but once addressed, the opioid risk screenings can be utilized as a conversation starter for any (and every) office visit. As was the phrase www.painweek.org | PWJ

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in the 1963 potato chip ad, “Betcha can’t eat just one,” when considering the frequency of conducting opioid risk screenings, one should consider that one is never enough.

References: 1. Hollandsworth S. Lay’s of our lives: why we couldn’t eat just one. Texas Monthly.

Available at: texasmonthly.com/food/lays-of-our-lives/.

2. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016, 65 CDC MMWR 1–49 (Mar. 18, 2016). Available at: cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.

3. FDA. Sample patient agreement forms. Available at: drugabuse.gov/sites/ default/files/files/SamplePatientAgreementForms.pdf.

4. Yudko E, Lozhkina O, Fouts A. A comprehensive review of the psychometric properties of the Drug Abuse Screening Test. J Sub Abuse Treat. 2007;32(2):189–198.

5. Butler SF, Fernandez K, Benoit C, et al. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain. 2008;9(4):360–372.

6. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005;6(6):432–442.

7. Cheatle MD, Compton PA, Dhingra L, et al. Development of the revised opioid risk tool to predict opioid use disorder in patients with chronic nonmalignant pain.

J Pain. 2019 Jan 26. [ePub ahead of print] 8. Belgrade MJ, Schamber CD, Lindgren BR. The DIRE score: predicting outcomes of opioid prescribing for chronic pain. J Pain. 2006;7(9):671–681.

9. Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the Current Opioid Misuse Measure. Pain. 2007;130(1–2):144–156.

10. Adams LL, Gatchel RJ, Robinson RC, et al. Development of a self-report screening instrument for assessing potential opioid medication misuse in chronic pain patients. J Pain Symptom Manage. 2004;27(5):440–459.

11. Compton PA, Wu SM, Schieffer B, et al. Introduction of a self-report version of the Prescription Drug Use Questionnaire and relationship to medication agreement noncompliance. J Pain Symptom Manage. 2008;36(4):383–395.

12. Compton P, Darakjian J, Miotto K. Screening for addiction in patients with chronic pain and “problematic” substance use: evaluation of a pilot assessment tool.

J Pain Symptom Manage. 1998;16(6):355–363.

“Betcha can’t eat just

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one”

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By Corinne Cooley DPT / Heather King PhD

key topic

There is a back pain epidemic. Chronic low back pain is the leading cause of disability, affecting 1 in 4 Americans, and healthcare costs are huge.1,2 Low back pain interferes with patients’ quality of life and leads to increased healthcare utilization,3 with up to 72% using pain medications to relieve symptoms.4,5 The helpfulness of medications, unfortunately, is limited, with some studies indicating effectiveness in only 30% to 50% of patients taking the medication.6 Though evidence shows conservative interventions of physical therapy (therapeutic exercise, manual therapy) alone can improve function, interdisciplinary centers that include psychological, physical (occupational or physical), and medical treatments combined have shown to be more effective in reducing disability and improving function for patients with chronic pain.7 Avoiding pain, especially chronic pain, can cause patients to put their life on hold until the pain is reduced.

This article explores how shifting treatment focus from “avoiding the stick” (pain) to “focusing on the carrot” (values-based living) can improve quality of life in those who suffer with chronic low back pain. Specifically, we will summarize the outcomes of patients with chronic back pain who participated in our treatment intervention, an outpatient interdisciplinary program* called “Backs in ACTion” (see Table 1). Patients were a part of a nonrandomized group that received nonpharmacological interventions such as pain psychology (acceptance and commitment therapy) and physical therapy interventions such as pain neuroscience education, individual therapeutic exercise, and group exercise to reduce distress and pain related fear of movement with the primary aims of improving their quality of life, reducing disability, and improving participation in self-directed, personally valued activities. *The Research Compliance Office of Stanford University in California reported that after review, its Institutional Review Board determined that this project did not meet the definition of research as defined in 45 CFR 46, or the definition of clinical investigation as defined in 21 CFR 56 as was thus considered to be IRB-exempt.

Table 1. Backs in ACTion Treatment Components Week 1

Week 4

→→ Pain neuroscience education →→ Behavioral activation →→ Self-regulation (diaphragmatic breathing) →→ Goal Setting and Action Plan

→→ Action Plan check-in →→ Mindfulness →→ Values →→ Experiential exercise →→ Group quiz with neurophysiology of pain questionnaire* to review pain neuroscience concepts →→ Updated Action Plan

Week 2 →→ Action Plan check-in →→Time-based pacing for chronic pain →→ Sleep hygiene →→ Self-regulation (progressive muscle relaxation) →→ Updated Action Plan Week 3 →→ Action Plan check-in →→ Unhelpful thinking styles →→ Willingness/acceptance →→ Defusion →→ Experiential exercise →→ Updated Action Plan

Week 5 →→ Action Plan check-in →→ Values and committed action →→ Self as context →→ Experiential exercise →→ Updated Action Plan Week 6 →→ Action Plan check-in →→ Review of ACT concepts →→ Resources for self-management of chronic pain →→ Experiential exercise →→ Values-based relapse prevention plan and individual home exercise planned for next 2 weeks

*Revised Neurophysiology of Pain Questionnaire. Body in Mind. Research into the role of the brain and mind in chronic pain. University of South Australia & Neuroscience Research Australia. 2013. Available at: bodyinmind.org/wp-content/uploads/Revised-neurophysiology-of-Pain-questionnaire-1.

Pain neuroscience education uses metaphors to explain to patients

the biological processes of pain and has been shown to change pain beliefs, catastrophizing, and physical performance on test measures and ability to cope with their pain condition.8,9 Neuroscience education provides information to allow the patient to reconceptualize their pain as less threatening and includes key concepts such as pain as a normal biological process, pain is an emergent output of the brain based on distributed brain activity, and a human can experience pain in the presence or absence of tissue damage. Our outcomes are compared with research outcomes from a program based on cognitive behavioral therapy (CBT) with movement, as well as an intensive inpatient program, to compare and contrast the varying treatment approaches and intensity of treatment delivery.

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key topic

Treatments:

What Are the Advantages of Interdisciplinary Pain Management vs Monotherapies?

Interdisciplinary pain management often includes a team of pain physicians, physician assistants, nurses, psychologists, physical therapists, or occupational therapists. These approaches treat all aspects of the patient experience simultaneously using a biopsychosocial approach rather than addressing one piece of the puzzle at a time. Psychological and movement based therapies delivered alone as a monotherapy such as CBT and physical therapy (PT) all have modest effect sizes on decreasing pain and improving disability.10,11 Currently there is moderate evidence that suggests interdisciplinary treatment, compared to other active treatments, reduces back pain and disability in the short term.7,12 Research from interdisciplinary pain clinics have found that anxiety and depression correlate with higher pain severity and pain related disability and predict changes in pain interference over time.13 In addition to outpatient treatments, intensive interdisciplinary inpatient programs for chronic pain have statistically significant improvements in acceptance, decreased disability, depression, and pain related anxiety for 3 months up to 3 years after the intervention.14

Using a Biopsychosocial Approach:

Integrating Psychological and Behavioral Treatments for Back Pain

Patients seeking care for chronic pain often expect a diseasecurative approach, focusing on a biomedical model which often has limited success. Treatments focusing on the biopsychosocial model are recommended for chronic pain, focusing on biological, psychological, and social factors that contribute to one’s unique experience of pain. Avoidance of pain is an expected and normal human response; however, in the context of chronic pain, this approach becomes problematic as it often leads to patients putting their life “on hold” until the pain is reduced or eliminated. This leads to important life activities becoming more and more restricted. Approaching pain treatment from a strictly biomedical understanding of pain (and treatment focused only on this approach) is more likely to fail.

Melzack and Wall acknowledged the power of the brain on patient’s experience with their conclusion on the gate control theory model suggesting “that psychological factors such as past experience, attention, and emotion influence the pain response and perception.”15 Current pain science indicates contributions from and interactions between a variety of biological, social, and psychological factors towards the evolution of chronic pain.16 Pain psychologists focus on empirically validated treatments that teach patients skills to live a full life with chronic pain while addressing fear-avoidant behaviors, unhelpful thoughts, beliefs, and behaviors, and various relaxation strategies.17,18 Acceptance based approaches focus on reducing the attempts to control or avoid pain that may

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worsen pain related dysfunction and distress due to maladaptive efforts to control an unchangeable aversive experience— chronic pain.19-21 From the standpoint of framing chronic pain approaches to patients, we identify “the carrot” or the “stick.”

Avoiding or controlling the pain is what we refer to as “the stick” and this approach moves people away from important activities and interactions in life. This avoidance at all costs has a tremendous cost of quality of life over time. We asked ourselves what would be more meaningful and helpful than controlling or avoiding pain, which led up to identifying “the carrot.” We set forth to create an interdisciplinary program using values-based strategies taken from the acceptance and commitment therapy (ACT) model combined with PT to facilitate psychological flexibility, shifting patients from the stick to the carrot.

What is Acceptance and Commitment Therapy?

ACT has shown to be favored over controls for the treatment of chronic pain for measures of pain acceptance, functioning, anxiety, and depression.22 Simply put, ACT is a 3rd wave psychotherapy which recognizes that attempts to avoid unwanted internal experiences, such as uncomfortable thoughts, feelings, memories, urges, or even chronic pain, are likely to be unhelpful and over time can amplify distress and reduce quality of life.23 ACT focuses on psychological flexibility, combining mindful acceptance (taking a present moment nonjudgmental stance) of both positive (wanted) and negative (unwanted) experiences, while engaging in behaviors that are consistent with one’s identified valued life directions.24 ACT’s focus on improved function and enhanced willingness towards active participation in a meaningful life, even in the context of painful experiences, is in contrast to other approaches that encourage avoiding discomfort via control based strategies, which often restrict one’s activity and function.25 While empirical evidence demonstrates the effectiveness of ACT, this paradigm shift can be difficult for patients to make without professional guidance and experiential exercises. As such, our program focused on helping patients identify their values and actively engage in behaviors consistent with these values. Further, they were introduced to complementary strategies aimed at decreasing the impact of painful thoughts, feelings, memories, urges, and sensations that naturally arise while in pursuit of these goals.

This shift from focusing one’s energy and time on avoiding or controlling pain (stick) to their values (carrot) has proven to be deeply motivating for our patients.

For example, if a patient is fearful that walking will increase their pain and cause further damage to their body, they may avoid walking more than a few minutes at a time. This leaves them housebound, minimally active, and with what ACT refers to as “values illness” or not engaging in meaningful activities.

Our approach to these types of situations has been to first build confidence by educating the patient on the safety of the target activity, such as walking on the treadmill. Next, we help them Q 2 | 2019

This shift from focusing one’s energy and time on avoiding or controlling pain (stick) to their values (carrot) has proven to be deeply motivating for our patients.”

Table 2. Intervention characteristics Baseline Mean Scores (Standard Deviation [SD])

6 Week PostIntervention Score (SD)

3 Months PostIntervention Score (SD)

Age

56.5 (13.49)

Disability (RMDQ)

11.95 (5.45)

6.45 (4.7)*

4.75 (4.1)*

Pain Acceptance (CPAQ)

49.62 (10.7)

74.6 (16.5)*

74.4 (15.9)*

Pain (NPRS)

6.08 (2.04)

4.1 (1.9)*

4.18 (1.6)*

Pain Catastrophizing (PCS)

19.47 (11.1)

11.94 (12.2)

11.75 (8.8)

*Statically significant change or P<.05 from baseline scores RMDQ= Roland Morris Disability Questionnaire; CPAQ=Chronic Pain Acceptance Questionnaire; NPRS=Numeric Pain Rating Scale; PCS=Pain Catastrophizing Scale

explore if the target activity is consistent with their unique intrinsic values. In this example, if this person identifies health as a particularly salient personal value, the ways in which treadmill exercise benefits long-term physical health, and is thus in line with their identified value, would be highlighted. Similarly, if patients identify relationships with others as a personal value but avoid social activities because they fear the amount of walking involved in these events, we would help promote insight that increased endurance from walking may give them the confidence to be able to say “Yes” to activities with friends and family.

As a final example, if independence is something they value, they may realize that choosing to walk on the treadmill now may help them have the stamina to run errands on their own, thus promoting action towards this identified value. To further bolster results, the outcomes of choosing to avoid walking on the treadmill and ways in which this choice moves them away from, rather than towards, their values would be explored. In summary, the role of the ACT psychologist is to help the patient evaluate each target activity regarding its consistency with their identified values and allow the patient to choose to initiate the exercise or not, based on their personal conclusion.

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Stanford Pain Management Center Treatment Intervention To develop a values-based pain management program, we designed the current pilot project with several small group cohorts. A total of 24 participants (mean age=56.5) who had been experiencing chronic low back pain for a minimum duration of 1 year attended the program. Intervention took place at an outpatient chronic pain management clinic and included 2 hours of pain psychology and 2 hours of PT for each session (see Table 1 for treatment components). Group members participated in 2 sessions each week for 6 weeks for a total of 48 hours of intervention. Measurements were taken pre-intervention, post-intervention, and 12 weeks post-intervention and included the Roland Morris Disability Questionnaire,26 Chronic Pain Acceptance Questionnaire,27 Numeric Pain Rating Scale, Pain Catastrophizing Scale,28 and objective physical tests including a 6-minute walk test and patient selected valued activity for time tolerance. Baseline and post-intervention characteristics are presented in Table 2. Patients were not required to taper or decrease their analgesic medication regimen during this intervention. www.painweek.org | PWJ

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…treat

all aspects of the patient experience addressing one piece of the puzzle at a time.”

Table 3. Chronic pain acceptance across treatment interventions Pre-CPAQ Score

Post-CPAQ Score

ACT (no PT)

51

73.78

CBT+PT

45.24

57.67

CBT (no PT)

55.72

59.51

Backs in ACTion

49.6

74.6

Outcomes from “Backs in ACTion” Our data indicate that patients improve function, reduce disability, and improve pain acceptance with our treatment intervention. Using the Roland Morris Disability Questionnaire26 pre-intervention mean score was 11.95 and reduced to 6.45 post-intervention resulting in a 48% reduction in disability, which is clinically significant. Two tailed t-tests to compare pre- to post-intervention scores for disability were run and resulted in P=.0000048, which is statistically significant (SS).

Two tailed t-tests for disability run for pre-intervention scores and compared to 3 month results also resulted in significance (P=.0008).

The Chronic Pain Acceptance Questionnaire27 is a 20-item questionnaire that measures pain related acceptance, with a subscale for pain willingness and activity engagement, with a higher score indicating a greater degree of acceptance. The initial mean score was 49.62 and increased to 74.6 post-intervention with a mean 25-point increase in acceptance. Two tailed t-tests to compare pre- to post-intervention scores for acceptance were run and resulted in P=.0000000016 (SS). Two tailed t-tests to compare pre-intervention scores and 3-month scores also resulted in significance (P=.00000001). These results are similar to changes seen in an intensive inpatient study with 97 to 130 contact hours over the course of treatment.14 In a preliminary study,29 pain related acceptance is a mediator between bodily pain and pain catastrophizing (82%).

Mean pain ratings reduced from 6.08 to 4.1, which did not reach clinical significance. However, two tailed t-tests to compare preto post-intervention scores for pain were run and resulted in P=.00005 (SS). Two tailed t-tests to compare pre- to 3-month

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Table 4. Catastrophizing changes across groups Pre-PCS Score

Post-PCS Score

ACT (no PT)

16

11.89

CBT+PT

18.09

18.83

CBT (no PT)

22.625

16.495

Backs in ACTion

19.4

12.1

PCS=Pain Catastrophizing Scale

intervention scores for pain resulted in P=.013 (SS). Unfortunately, the pain catastrophizing values did not produce a normalized data set for analyses.

Comparison of Backs in ACTion to Other Behavioral Treatment Groups The Stanford Pain Management Center offers comprehensive services including pain psychology and physical therapy treatments. We have collected data on chronic pain acceptance across our other psychological and physical therapy treatment groups and found that ACT based treatments had significantly larger changes in pain related acceptance than the CBT based treatment groups (see Table 3). The contact hours were 48 hours for Backs in ACTion, 24 hours for ACT (no PT), 18 hours for CBT + PT, and 13.5 hours for CBT (no PT). As expected, the biggest change in acceptance was observed with ACT with and without PT compared to CBT with and without PT treatments, suggesting that values-based treatments appear to outperform pain focused treatments. The addition of physical therapy resulted in a small increase in pain related acceptance over the psychological intervention alone. Additionally, the results show a dose effect, suggesting that an intensive outpatient program with more treatment hours yielded greater gain in pain acceptance.

The Pain Catastrophizing Scale is a 13-question measure on a 5-point Likert scale (0=not at all, 4=all the time) to measure catastrophic thinking related to pain.28 The clinical cutoff for elevated catastrophizing is 30 and the maximum score is 52. All of our groups initially demonstrated subclinical catastrophizing scores and ended with subclinical scores post group (see Table 4). Previous research has demonstrated PCS reductions Q 2 | 2019

of approximately 38% to 44% were best associated with return to work and low pain intensity ratings at follow-up.30 Greatest reduction in pain catastrophizing was observed after Backs in ACTion (38% reduction), followed by CBT (27% reduction) or ACT alone (25% reduction). In contrast, CBT + PT had a 4% increase.

These results suggest that when pain psychology was offered in conjunction with physical therapy, a values-based approach reduced pain catastrophizing whereas a psychological approach to focus on controlling pain did not.

Conclusions We developed an interdisciplinary program with 48 hours of provider-patient contact involving simultaneous ACT based psychological interventions and physical therapy to study the effects of this integrated treatment approach on several psychological mechanisms including pain catastrophizing, pain acceptance, and fear avoidance in patients with chronic back pain. We anticipated that a values-based program would provide patients with more benefit in improving quality of life, increase function, and foster active participation in a values-driven life, despite their chronic pain. As expected, our pilot project demonstrated that an ACT approach combined with PT provided a greater increase in pain acceptance and a greater reduction in pain catastrophizing compared to CBT, with and without PT. Our patients in the Backs in ACTion treatment group had 48% reduction in disability, 50% improvement in pain related acceptance, and 38% reduction in pain catastrophizing scores after 6 weeks of treatment. These results were maintained at 3 months post-treatment demonstrating sustainable benefit over time. Our results suggest that shifting patients’ focus from the stick to the carrot in their chronic pain treatment was a key component of the program and its success.

10. Eccleston C, Morley SJ, Williams ADC. Psychological approaches to chronic pain management: evidence and challenges. Br J Anaesth. 2013;111(1):59–63.

11. Hayden JA, Van Tulder MW, Malmivaara AV, et al. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005;142(9):765–775.

12. Van Middelkoop M, Rubinstein SM, Kuijpers T, et al. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain. Eur Spine J. 2011;20(1):19–39.

13. Oliveira DS, Vélia Ferreira Mendonça L, Sofia Monteiro Sampaio R, et al.

The impact of anxiety and depression on the outcomes of chronic low back pain multidisciplinary pain management—a multicenter prospective cohort study in pain clinics with one-year follow-up. Pain Med. 2019;20(4):736–746.

14. Vowles KE, McCracken LM. Acceptance and values-based action in chronic pain: a study of treatment effectiveness and process. J Consult Psychol. 2008;76(3);397.

15. Melzack R, Wall PD. Pain mechanisms: a new theory. Science.

1965;150(3699):971–979.

16. Nicholas MK. Why do some people develop chronic, treatment-resistant pain and not others? Pain. 2018;159(12):2419–2420.

17. Monticone M, Ferrante S, Rocca B, et al. Effect of a long-lasting multidisciplinary program on disability and fear-avoidance behaviors in patients with chronic low back pain: results of a randomized controlled trial. Clin J Pain. 2013;29(11):929–938.

18. Leeuw M, Goossens ME, Linton SJ, et al. The fear-avoidance model of musculoskeletal pain: current state of scientific evidence. J Behav Med. 2007;30(1):77–94.

19. McCraken LM. Learning to live with pain: acceptance of pain predicts adjustment in persons with chronic pain. Pain. 1998;74(1):21–27.

20. McCracken LM, Morley S. The psychological flexibility model: a basis for integration and progress in psychological approaches to chronic pain management.

J Pain. 2014;15(3):221–234.

21. McCracken LM, Davies M, Scott W, et al. Can a psychologically based treatment help people to live with chronic pain when they are seeking a procedure to reduce it?

Pain Med. 2015;16(3):451–459.

References

22. Veehof MM, Trompetter HR, Bohlmeijer ET, et al. Acceptance-and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review.

Cogn Behav Ther. 2016;45(1):5–31.

1. Hoy D, March L, Brooks P, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014;73(6):968–974.

23. McCracken LM. Contextual Cognitive-Behavioral Therapy for Chronic Pain (Progress in Pain Research and Management, Vol. 33). Seattle, WA: IASP Press; 2005.

2. Lee H, Hübscher M, Moseley GL, et al. How does pain lead to disability?

A systematic review and meta-analysis of mediation studies in people with back and neck pain. Pain. 2015;156(6):988–997.

24. Hayes SC, Strosahl K, Wilson KG. Acceptance and Commitment Therapy: an Experiential Approach to Behavior Change. New York, NY: Guilford; 1999.

3. Dueñas M, Ojeda B, Salazar A, et al. A review of chronic pain impact on patients, their social environment and the healthcare system. J Pain Res. 2016;9:457.

4. Enthoven WT, Scheele J, Bierma-Zeinstra SM, et al. Analgesic use in older adults with back pain: the BACE study. Pain Med. 2014;15(10):1704–1714.

5. Crow WT, Willis DR. Estimating cost of care for patients with acute low back pain: a retrospective review of patient records. J Am Osteopath Assoc.

2009;109:229–233.

6. Moore A, Derry S, Eccleston C, et al. Expect analgesic failure; pursue analgesic success. BMJ. 2013;346:f2690.

7. Kamper SJ, Apeldoorn AT, Chiarotto A, et al. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and metaanalysis. BMJ. 2015;350:h444.

8. Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004;20(5):324–330.

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9. Watson JA, Ryan CG, Cooper, LC, et al. Pain neuroscience education for adults with chronic musculoskeletal pain: a mixed-methods systematic review and meta-analysis. J Pain. 2019 Mar 1. [ePub ahead of print]

25. Hayes SC, Duckworth MP. Acceptance and commitment therapy and traditional cognitive behavior therapy approaches to pain. Cogn Behav Prac. 2006;13:185–187.

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27. McCracken LM, Vowles KE, Eccleston C. Acceptance of chronic pain: component analysis and a revised assessment method. Pain. 2004;107(1–2):159–166.

28. Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7(4):524–532.

29. Ravn SL, Vang ML, Vaegter HB, et al. Pain-related acceptance as a mediator in the fear avoidance model of chronic pain: a preliminary study. Pain Med. 2018;19(9):1764–1771.

30. Scott W, Wideman TH, Sullivan MJ. Clinically meaningful scores on pain catastrophizing before and after multidisciplinary rehabilitation: a prospective study of individuals with subacute pain after whiplash injury. Clin J Pain. 2014;30(3):183–190.

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medical music psychotherapy in the treatment of pain

By John F. Mondanaro MA, MT-BC, LCAT

music therapy

abstract

Medical music psychotherapy as a treatment discipline draws from both the physical and social sciences in understanding and identifying myriad entry points to treating patients.

As an integrative modality in pain treatment, it is not regularly accessed by medical providers considering treatment planning due primarily to unfamiliarity with the modality and varying degrees of service availability in the medical landscape. With its growing body of randomized control trials showing efficacy, medical music psychotherapy contributes to a new medical narrative that values relationship as a vehicle by which to deliver truly individualized care. Understanding medical music psychotherapy and its role in treating pain through a social theory framework inclusive of 3 inextricably linked perspectivesâ&#x20AC;&#x201D; temperament, culture, and identityâ&#x20AC;&#x201D; lends insight as to its place in integrative and individualized care.

Music as a language in and of itself holds the potential to both encapsulate culture yet transcend cultural barriers because it is universally shared.1-5 The effect of music listening on physiological parameters is generally accepted in the medical paradigm because it rests in accommodation with a medical narrative focused on treating the body. There is substantial literature on the use of music to calm, relax, and positively impact the release of stress from pain, with a central point of efficacy being the relational aspects of treatment afforded in music therapy.4-20

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Therapists draw from both the physical and social sciences in u n d e r s t a n d i and identifying myriad entry points to treating patients.

Medical music psychotherapy as a treat-

ment approach with those suffering from somatic pain ensues from impeccable assessment informed by multiple theories that contribute to understanding the human experience.8,9 Such care is achieved through an embrace of integrative philosophy aimed at approaching treatment from a culturally informed perspective, where culture is defined as being unique to each individual.21-23 Medical music psychotherapy, as practiced within the Louis Armstrong Center for Music and Medicine (LACMM) of Mount Sinai Beth Israel in New York, embraces and applies intervention to facilitate goals within the physical domain, while maintaining relationship as central to care.4,5,7-11,18-20 Therapists draw from both the physical and social sciences in understanding and identifying myriad entry points to treating patients. Its focus on individual narrative contributes positively to treatment efficacy by raising the individual’s story and identity to salient consideration in treatment planning. The relationship between patient and practitioner may at times be diminished within a treatment model focused on measurable outcomes. Efficacy trials as the gold standard by which reimbursement for treatment and services are determined are logical in the physiological domain, but are less viable in understanding the human experience and specifically the nuances of human relationships. Fostering therapeutic relationships in general takes personal time and investment, and in medical treatment it requires both of these tenets, as well as a belief system that values personal narrative as a primary entry point to understanding an individual being treated for pain. Disciplines hailing from the social sciences, and specifically helping professions like music therapy, bring significant insight to patient care because assessment and intervention are navigated in the here and now, while considering patients’ world views and cultural narratives.

50 PWJ | www.painweek.org

n

g

The LACMM has been resilient in medical culture by maintaining an integrative approach adherent to expected research standards. The center’s attendance to vulnerable populations such as those with cardiopulmonary disease, cancer, HIV/AIDS, and chronic conditions like endometriosis and back pain has been enduring since its beginning in 1994. Growing an understanding of medical music psychotherapy worldwide for almost 25 years, the LACMM has generated mixed methods research that has earned publication in such high-impact journals as Journal of Perianesthesia Nursing,10 Pediatrics,11 American Journal of Orthopedics,7 Journal of Radiation Oncology,18 and Respiratory Medicine.19 Measuring what can be measured and writing qualitatively about the lived experience of study participants has kept the LACMM relevant within the medical paradigm, but also authentic to its art and treatment philosophy. Understanding medical music psychotherapy through a framework of cultural considerations, social theory, and current literature on temperament elucidates a myriad of therapeutic entry points afforded in a psychotherapeutic process that is individualized, interdisciplinary, and integrative.5,6,10-14,21-23

Theories generated within the social sciences provide context within which to understand the belief systems that underlie patients’ coping styles, compliance, and general attitudes about illness and treatment. By drawing upon these theories, therapists contribute to the story that is generated around any given patient by the interdisciplinary treatment team. For example: Q 2 | 2019

• System justification theory24,25 helps to interpret an individual’s belief in a just world, and this understanding may illuminate patients’ perspective on available treatment options as well as expectations of reward for treatment compliance. This may be especially salient in cases where the individual’s locus of control is externalized. Being a “good patient” in the eyes of the treatment team may subvert an individual’s ability to authentically collaborate with providers • Schemata theory25-27 looks at the cognitive structures or schema that develop and are reinforced through repetition, subsequently drive behaviors, and guide information processing. Here, patients experiencing their needs being met or not met may form biases that shape future experiences • Self-affirmation theory28-34 speaks to affirming individuals in the healthiest aspects of their being, which serves to support the maintenance of defenses against medical threat

① Novelty seeking—exploratory activity of the pain experiencing individual vs active avoidance of frustration

② Harm avoidance—active pessimism and anticipatory worry, as well as passive avoidance due to fear and uncertainty

③ Reward-dependence—maintenance of ongoing behaviors hinged to approval seeking from others

④ Persistence—perseverance in life pursuits in spite of frustration and fatigue Further developing his theory, Cloninger identified character as a complement to temperament, also defining it across dimensions:

• Self-determination theory35,36 lends insight into patients’ motivations to be active participants in their care

① Self-directedness—will, self-determination,

• Social identity theory37-44 offers insight into behavioral choices that can include terms of desirability for in-group vs out-group status

help from others

• Family systems theory5,6,45,46 enables insight into the satellite of relationships, positive or negative, being navigated by an individual, as well as the communication styles of, and roles held by, members of one’s biological or chosen family The framework created by the synthesis of these theories contributes to our understanding of individuals’ responses to the medical circumstances in which they may find themselves.

The findings of recent research on temperament is often corroborated by a growing understanding of both cultural and social theory.

For the past 20 years, the study of temperament has lent a biomedical perspective on the coping strategies of individuals across age,47-50 diagnosis and trauma history,51-55 and ethnicity.47,50,53,56,57 A central assertion of this research is that temperament is inborn at a genealogical level and mitigated to a degree by social stimuli across the lifespan.58 In the 1980s, psychologist Robert Cloninger asserted an understanding of temperament that makes sense today because he asserted an implicit Q 2 | 2019

distinction between the biogenetic mechanisms underlying temperament and the socially and environmentally influenced mechanisms, which he referred to as “character.”58 Cloninger discussed 4 primary dimensions of temperament:

and purpose

② Cooperativeness—empathy, and acceptance of ③ Self-transcendence—spirituality The beauty of Cloninger’s theory that gives it staying power is its fluidity across, and acknowledgement of, several points of rationale for patients’ coping styles.

Temperament and Exercise Studies correlating temperament with exercise and athleticism have suggested a relationship between pain coping and catastrophizing.48,59,60 Patterns of temperament in young children have been shown to influence decision-making about physical exercise in adolescents.48 Body image, self-esteem, and agency all central to the arduous journey of identity formation in adolescence are meaningfully correlated in the temperament story.50 The implication of temperament as an early indicator of healthy lifestyle choices has implications for the importance of pain coping strategies such as exercise and mind body practices in later life. Long accepted views about the importance of physical exercise in the management of pain symptoms has been reinforced by looking at the relationship between exercise and endurance in athletes,59 and in the stamina of firefighters as well.60 Studies such as these offer a line of rationale from which a convincing discussion of resilience in those coping with illness and pain can be extrapolated and substantially connected to the literature on exercise and pain. Resilience www.painweek.org | PWJ

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in those undergoing chemotherapy is the focus of a current institutional review board protocol of the LACMM, in which cancer related pain in those undergoing infusion treatment is intervened through active drumming, singing, and expression across both verbal and nonverbal forums.61

Temperament and Cultural Considerations Others have looked at the relationship between temperament and cultural factors.47,50,53,56,57 A 2010 study of 117 Spanish American children attending an outpatient clinic in a border region of southern California identified 4 types of temperament: depressive, cyclothymic, hyperthymic, and anxious/irritable.

The study offered insight that could be valuable in best practice by diminishing the cultural bias that can occur during diagnosis and treatment. While cultural competence and sensitivity are integral to good care, regionally based stereotypes and biases held by frontline staff may be difficult to monitor and may potentially emerge unconsciously during all phases of care.

Another report on Korean adolescents50 identified a connection of childhood temperament features such as impulsiveness, shyness, and irritability as possibly correlating to depression in minority teens growing up in the United States. As mentioned above, typical adolescent issues of peer acceptance and vigilance to body image, exacerbated by marginalization to outgroup status, may contribute to depressive symptoms.

Although contrasting in the findings, the research on temperament may offer clinicians additional insight to understanding how pain is perceived by pain sufferers. Like social theory, however, theories of temperament cannot tell the whole story.

Raising cultural and psychosocial factors to salience in how we understand the human experience is the subject of contemporary social science research. Ecological theories of development following the pioneering work of Uri Bronfenbrenner62 offer explanations as to why people are the way they are in their navigation of the world around them. Bronfenbrenner suggests 4 levels of immersion that contribute to an individual’s developing sense of self across the lifespan. At the core is the microsystem, in which an individual explores reciprocity

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within the immediate functional social system. This space may be inclusive of familial relationships, as well as those forged with peers at school, camp, and church, but moving beyond the dyad, it highlights the physical navigation of tasks. The next sphere referred to as the mesosystem contains various microsystems, and identifies the interrelational aspects of the individual within various settings such as home, school, work, and camps. Continuing outward, the exosystem focuses on the various settings in which an individual functions, but unlike the mesosystem, it does not contain the individual but serves as the context in which the developing person interacts. The largest circle is the macrosystem, which considers the influence of overarching patterns or systems of culture factors such as politics, religion, and education. Healthcare and specifically the medical model reside here. The work of both Bronfenbrenner and Cloninger asserts that individuals responding to stressors such as trauma, illness, injury, and the profound losses that ensue do so by drawing from multiple sources of influence across life experiences.

Continuing along this trajectory is research that enhances our understanding of cultural influences and factors. The work of Hofstede, Hofstede, and Minkov63 looks at deeply held cultural belief systems. Some of these include ideas of power distance within a given country, which focuses on the relationship to authority and authority figures. Their work elucidates the relationships that patients have with their physicians, and more broadly with their belief in medical treatment.63-67 They discuss multiple dimensions for consideration in understanding individual motives and behaviors including the degree of individualistic vs collectivistic ideals that one engenders in life practices. This dimension lends insight into coping styles as shaped by positioning of an individual’s locus of control as internal or external, or as visible as whether one’s coping strategies are self-directed or externalized. Closely related is the dimension of in-group vs out-group desirability, which hails from identity theory and may contribute to an understanding of how some individuals self-identify as patients, and how they may be approaching care. In-group desirability proved to be an important factor in a study on temperament conducted across 3 cultural groups.47 The temperament of 111 toddlers, 20 months old, of European-American, Japanese-American, and Latin-American descent was investigated. While variance in temperament between these multicultural children was minimal, the finding reflected that desirability for in-group status (alignment with the majority) by multicultural mothers may have contributed to their minimizing of their child’s temperament in pain coping. The study suggests that the accuracy of reporting by mothers may be looked at more closely in terms of mothers’ cultures of origin and enculturated beliefs where “individuality and individualized traits are not prized, as they are in the United States.”47 Desire for in-group status may not entirely override instinctual responses to care providers or healthcare in general, and should be acknowledged amidst the possible variables navigated by practitioners. This body of research too can be understood as only a component in understanding those we serve, and not the whole story.

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10. Loewy J, Hallan C, Friedman E, et al. Sleep/sedation in children undergoing EEG testing: a comparison of chloral hydrate and music therapy. J Perianesth Nurs.

2005;20(5):323–331.

Most individuals develop across their lives a world view that cannot be narrowly assessed and treated from one perspective.

The study of temperament indicates yet another promising factor for consideration in understanding individuals’ motives for seeking and complying with treatment. As suggested before, it is the combination of theories as possible resources for better understanding that is important here, and not the idea that any one theory tells the whole story. Colloquially speaking, one size does not fit all. Contributing to a narrative that values relationship as a vehicle by which to deliver truly individualized care, the integration of such holistic treatment modalities as medical music psychotherapy with state of the art medical research and pharmacologic intervention suggests a new medical narrative.

Systems are slow to change, yet the current medical paradigm is additionally impacted by a growing public interest in individualized care.68-71 Providers’ comfort with resourcing a modality such as medical music psychotherapy is understandably hindered by the reality of limited accessibility and lack of familiarity with such treatment options. Haphazard attempts at presenting the growing body of research in integrative treatment like music therapy result in distrust and partial messaging that perpetuates an incomplete narrative of what individualized and integrative treatment means. Truthfully if the definition of best practice is to change, the medical paradigm must embrace individualized care through innovation and integration, and integrative professions must accept the charge to produce efficacy research and practice that can increase visibility, credibility, and availability of services.

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41. Steele CM, Spencer SJ, Aronson, J. Contending with group image: the psychology of stereotype and social identity threat. In: Zanna MP, ed. Advances in Experimental Social Psychology, Vol.34. New York, NY: Academic Press; 2002:379–440.

42. Tajfel H, Turner JC. The social identity theory of intergroup behavior. In: Worchel S, Austin WG, eds. Psychology of Intergroup Relations. Chicago, IL: Nelson Hall; 1986:7–24.

43. Van Zomeren M, Postmes T, Spears R. Toward an integrative social identity model of collective action: A quantitative research synthesis of three socio-psychological perspectives. Psychol Bull. 2008;134(4):504–535.

44. Walton GM, Cohen GL. A brief social-belonging intervention improves academic and health outcomes of minority students. Science. 2011;331:1447–1451.

60. Kosel N, Kose S, Deminrdel E, et al. The relationship between temperament and characters with physical fitness and pain perception in firefighters. J Mood Disord.

2016;6(4):218–226.

61. Hicks J, Baumann E, Garrido Rosa N. Culturally informed music psychotherapy: using Latin American music and repertoire in the treatment of pain and anxiety experienced by individuals receiving chemotherapy. In: Mondanaro J, Sara G, eds. Music and Medicine: Integrative Models in the Treatment of Pain. New York, NY: Satchnote Press; 2013:421–450.

62. Bronfenbrenner U. Toward an experimental ecology of human development.

Am Psychol. 1979;32(7):513–531.

63. Hofstede G, Hofstede GJ, Minkov M. Cultures and Organizations: Software of the Mind. New York, NY: McGraw Hill Books; 2010.

64. Bova C, Route P, Fennie K, et al. Measuring patient-provider trust in a primary care population: refinement of the health care relationship trust scale. Res Nurs Health.

2012;35:397–408.

65. Dima A, Lewith G, Little P, et al. Patients’ treatment beliefs in low back pain: development and validation of a questionnaire in primary care. Pain.

2015;156(8):1489–1500.

45. Taylor RB. Family: a systems approach. Am Fam Physician. 1979;20(5):101–104.

66. Ridd M. The patient-doctor relationship: a synthesis of the qualitative literature on patients’ perspectives. Br J Gen Pract. 2009;59(561):e116-e133.

46. Sharf R. Theories of Psychotherapy and Counseling: Concepts and Cases. 3rd ed.

Pacific Grove, CA: Brooks/Cole-Thompson Learning; 2004:479–525.

67. White P, Bishop F, Prescott P. Practice, practitioner, or placebo? A multifactorial, mixed methods randomized controlled trial of acupuncture. Pain. 2012;153(2):455–462.

47. Bornstein MH, Cote LR. Child temperament in three U.S. cultural groups.

Infant Ment Health J. 2009;30(5):433–451.

68. Hahm M, Katseres J. Integrative care: the evolving landscape in American hospitals. Am J Nurs. 2015;115(10):22–29.

48. Janssen JA, Kolacz J, Shanahan L, et al. Childhood temperament predictors of adolescent physical activity. BMC Public Health. 2017;17(8):1–11.

69. Maruthappu M, Hasan A, Zeltner T. Enablers and barriers in implementing integrated care. Health Syst. 2015;2(4):250–256.

49. Muris P, Meesters C, van den Haut A, et al. Personality and temperament correlates of pain catastrophizing in young adolescents. Child Psychiatry Hum Dev. 2007;38:171–181.

70. Nolte E, Pitchforth E. Policy Summary ll: What is the evidence on the economic impacts of integrated care? World Health Organization. 2014. Available at: euro.who. int/__data/assets/pdf_file/0019/251434/What-is-the-evidence-on-the-economicimpacts-of-integrated-care.pdf.

50. Therival J, Mcluckey L. Depression in adolescence: Korean American adolescents.

Cinahl Information Systems. February 3, 2017:e1-e5.

51. Bylinka J, Oniszczenko W. Temperament, beliefs about pain control, and pain intensity in endometriosis patients. J Clin Psychol Med Settings. 2016;23:410–419.

71. Stewart M, Belle Brown J, Donner A, et al. The impact of patient-centered care on outcomes. J Fam Pract. 2000;49(9):796-804.

52. Rzeszuteka M, Oniszczenkoa W, Burkackab F. Temperament traits, coping style and trauma symptoms in HIV men and women. AIDS Care.

2012;24(9):1150–1154.

53. Rzeszuteka M, Oniszczenkoa W, Schier K, et al. Trauma symptoms, temperament traits, social support and the intensity of pain in a Polish sample of patients suffering from chronic pain. Pers Individ Diff. 2015;83:13–17.

54. Rzeszuteka M, Oniszczenkoa W, Schier K, et al. Pain intensity, temperament traits and social support as determinants of trauma symptoms in patients suffering from rheumatoid arthritis and low-back pain. Int J Rheum Dis. 2016;19:412–419.

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By Jeffrey D. Pomerantz DO

By Jeffrey D. Pomerantz DO

not familiar with our corrections system might imagine jails and prisons to be ideal settings for detoxification and sobriety. Those of us familiar with our corrections system, however, know better. As a corrections physician for most of my career, I can state that it is a sad fact but a fact nonetheless that whatever one can get on the street can be gotten in a correctional facility, although in much lower amounts and at a much dearer price. After all, it is a matter of supply and demand: about half of all incarcerated persons meet criteria for drug abuse,1 and they carry their culture of abuse with them.

Controlled substances enter correctional facilities by a number of different

means, such as visitors hiding drugs on themselves, in handbags, or even in infants’ diapers. Letters with Suboxone behind the stamp or on the flap—or even in blots on letter paper in the same way LSD “tickets” were made during my college years— are less obvious techniques. Issuing prescription drugs with high abuse potential as “DOT” (directly observed treatment at the pill line window) rather than “KOP” (keep on person; may take back to cell or dorm) only means that some inmates become skillful at “cheeking”: diverting the pill from tongue to inside of cheek for concealment and later retrieval. If the nurse or the med tech crushes the pills and places them in water, diversion could be more difficult, but there is a market for drugged saliva.

Unfortunately, sometimes corrupted staff bring drugs in; this is rare but not unheard of. Drones have been used to airdrop drugs into recreation yards as well.

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As a corrections physician…I can state that it is a sad fact but a fact nonetheless that whatever one can get on the street can be gotten in a correctional facility…

Conning prescribers is as old a trick in prison as it is on the outside, but thankfully this has become tougher with new governmental “suggestions” and surveillance.

Once when I was the medical director of a county jail, I had one of my predecessors on my sick call roster. The only people on my sick call roster were, and still are, inmates. He had been incarcerated for selling narcotic prescriptions from his car in an inner city neighborhood.

I have been a witness for the DEA as well as federal and state attorneys general in a drugs-for-sex scandal involving a female physician prescribing gram-quantities of narcotics to a man prior to his incarceration, and then mailing prescriptions for the same to him prior to his (later canceled) release. Physicians and mid-level providers are not immune to greed, lust, and stupidity.

Since getting prescribed narcotics chronically is getting tougher, those who cannot afford illicit drugs sold on units or cell blocks are turning to alternatives. For instance, those enamored with ecstasy (MDMA) can combine gabapentin, topiramate, and clonidine in juice to make “Mollie water.” Sniffing crushed bupropion can produce a high, but causes nasal irritation; this can be prevented by sniffing crushed gabapentin first. This medication is itself a major drug of abuse behind the wire, and is highly sought after by inmates with any pain complaint real or otherwise.

Incarcerated addicts wishing to achieve sobriety face the dual hardship of drug availability and lack of adequate funding/staffing for substance abuse programming. Another challenged group is those with legitimate needs for chronic pain management, given the effect of governmental narcophobia on medical practice. Several states are considering scheduling gabapentin due to its concurrent abuse with narcotics, creating new hoops for legitimate patients to have to jump through. As on the street, inmates with chronic pain are being made to pay for the abuse of others. One might argue that group punishment is inappropriate for citizens of a free constitutional republic, but I digress.

I suppose that this is the point in an op-ed at which I am to don my rose-colored glasses and bloviate on how we are but an unfunded mandate away from solving these problems, but I will spare you such nonsense.

Concentrating on drug decriminalization (as in Portugal), meaningful sentencing reform over and above the First Step Act—and even the legalization, regulation, and taxation of all drugs—would be far more profitable while resulting in the decreased incidence of lethal overdose. If that does not give you pause to consider, how about strengthening our crumbling families and civil society, the chaos from which undoubtedly contributes to the current drug abuse climate? Stable, sober Q 2 | 2019

homes of family members engaged in civil society beats government programs by light years.

As a chronic pain patient I am most thankful for the research done by those who present this journal, as well as for other clinicians and researchers similarly engaged.

I am also thankful (not!) for the team of Big Government and Big Pharma: if it had not been for unethical marketing practices, the “pain as the fifth vital sign” debacle, and the draconian “War on Drugs,” we would not be incarcerating 1% of our population and I would probably be working for an HMO. Of course, there have been enough corrupt and/or stupid medical providers, but we cannot forget others: the abusers themselves, and the researchers and clinicians treating substance abuse as if it neutralizes a person’s moral agency, dehumanizing and objectifying the former while furthering the Nanny State’s curtailment of people’s freedoms.

This is a trap best avoided.

Per substance abuse and pain management, I am skeptical of any government programming not involving maximizing personal freedom – and responsibility.

Our political-legal climate is in dire need of reform regarding these topics, and it is somewhat refreshing to see this as, perhaps, the last bipartisan cause in our polarized nation. I am not suggesting not being tough on crime; rather, I suggest that there should be far fewer crimes to need to get tough on than the present tally. Decriminalization of all drugs would spare an all-too-large number of people the felon’s scarlet letter, thereby avoiding roadblocks to housing, employment, and a plethora of other necessities most of us take for granted. It would also vouchsafe our fundamental right to self-medicate.

Finally, both substance abuse and chronic pain are problems with biopsychosocial bases rather than merely medical issues; prescribing medications is but one part of the solution rather than a panacea. Cognitivebehavioral therapy, support systems including religious/ spiritual involvement, and the attenuation or elimination of legal stigmata are equally important, and neglected at our peril.

Dr Pomerantz serves as medical director at Southern State Correctional Facility in Delmont, NJ. The opinions expressed herein do not necessarily reflect the views of Rutgers University Correctional Health Care.

Reference 1. The Center for Prisoner Health and Human Rights. Incarceration, substance abuse, and addiction. Available at: prisonerhealth.org/educational-resources/ factsheets-2/incarceration-substance-abuse-and-addiction.

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Education moves forward. www.painweek.org

short cuts

Jessica Geiger-Hayes pharmd, BCPS, CPE Clinical Pharmacist, Palliative Care

I rather enjoy flying by the seat of my pants.

jessica GeiGeR-HaYeS

OhioHealth Riverside Methodist Hospital

GPS Columbus, Ohio Typical Day There really is no such thing as a typical day for me, and I rather enjoy flying by the seat of my

pants. In general I’ll go see patients as needed and talk to them about symptoms, new medications, side effects, etc. I also work through drug information questions for my team and precept students, and participate in research projects. My favorite part of the day is when I walk in my front door and say hi to my kids. I have three: Olivia (12), Ailee (8), and Ian (5). They are amazing little humans and it is so fun to watch them each come into their own. I unwind by reading or watching a series on Netflix if I’m home, but I am an extrovert at heart so my favorite thing for unwinding is being with people, be it my kids or my friends. Persona I’m passionate about what I do and not afraid to speak up when needed. These are probably the characteristics that will help me on my journey within pain management and palliative care. Social Media Habits I don’t follow anything specific on social media, but I like to scroll through Facebook to see what my friends from out of town are up to. I have tried really hard to use Twitter but I just can’t get the hang of it. I will occasionally share some pictures on Instagram. Contribution I really enjoy talking to people and like to think my patients feel comfortable opening up to me, which allows for much better symptom and medication management. When I go into a patient’s room, I immediately find a place to sit so I’m not standing over the person in the bed. I can remember a patient from a couple years ago. From the chart it looked like everything was fine. The nurse said he wasn’t reporting increased pain and had minimal medication. I walked into the room to follow-up on his symptoms, and he was asleep. I didn’t want to wake him because he looked so comfortable. As I was walking away he asked who was there and where I was going. We started talking and I did a symptom reassessment. I was getting up to leave and he said, “Please don’t go.” He then told me he was afraid to be alone. This wasn’t documented anywhere in the chart and the physician on my team had not heard that at all. It turns out, the medication he was taking wasn’t for pain, but to try to not experience the loneliness of being in the hospital. People They’re not public figures, but super big deals to me: my parents. They have always encouraged me to pursue what fuels my passion, showed me what hard work looks like, and taught me a good work ethic. If I had to choose a public figure, I would say Betty White... she seems unstoppable. Words The Art of Racing in the Rain, by Garth Stein, is the most recent book I read and I would highly recommend it. It’s the life story of a dog, told from the dog’s perspective. I also love anything by Brené Brown. Popcorn I really love the Mamma Mia! movies. I watched the second one, Mamma Mia! Here We Go Again, in the theater 3 or 4 times. My kids also love them and we have marathons at the house. We all know all the songs and quote dialog as it fits into our conversation. I was a musician before I became a pharmacist (I sing and play electric bass and saxophone) and I love movies that also have a great soundtrack. Painweek I absolutely love getting to interact with everyone and learn about aspects of pain management that are different from where I currently practice. It’s great that there is such a diverse schedule offered.

Q 2 | 2019

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By Doug Gourlay md, msc, frcpc, fasam

“Of all the things you may do in response to abnormal results/behaviors, the one thing you must not do is to ignore them.”

Failing to document your patients’ struggles, as evidenced by abnormal UDT results or otherwise, is not doing you OR your patient a service.

When the level of complexity exceeds your experience or resources, you should make referrals to another treatment provider.

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short cuts

A 17-question survey, administered from 11.25.18 to 12.2.18 to

of children ages 13 to 24 highlighted shortcomings in parental understanding of prescription opioids for management of their children’s pain. Parents expressed concern yet ~66% believed opioids were the best available treatment option for acute or postsurgical pain.

83% were confident in their ability to safely oversee their child’s opioid prescription.

59% said they would discuss nonopioid options with their child’s physician, but only 37% did so.1

A study found that

Smartphone use is a risk factor for neck pain, and young people are experiencing “text neck” at earlier ages than previous generations. A research team studied video recordings of

queried on their driving habits, who had used cannabis for pain management, had also driven within 2 hours of consumption ≥1 times in the past 6 months. 21% reported that they had been “very high” while driving.

The findings are based on a survey of

aged 18 to 25 years who logged <8 hours per day on their phones. The average rapid upper limb assessment score for the study cohort was 6 compared to an acceptable level of 1 to 2.

of medical cannabis in Michigan who sought certification or recertification for use for their chronic pain in 2014 and 2015.3

In a randomized trial of

Intranasal ketamine is as effective as intranasal fentanyl for the relief of pain from acute extremity injury in children.

A study randomized

who underwent hip or knee replacement surgery, 1 group received standard postprocedure education while a 2nd cohort also received automated text messages from their physician.

The text/video messages, totaling ~90 communications per patient over a 6-week interval, provided encouragement and instruction re postoperative exercise & recovery. Compared to the control group, the text-message group stopped opioids 10 days sooner, spent +9 minutes on daily home exercise, had greater knee motion 3 weeks postprocedure, and reported higher mood scores.2

to receive intranasal ketamine 1.5 mg/kg and 42 children to receive intranasal fentanyl 2 mcg/kg.

Similar significant pain reduction was observed in both cohorts at 15, 30, and 60 minutes postadministration. The ketamine recipients reported ≥1 adverse effect more frequently than the fentanyl subjects (77% vs 31%) but these were classified as minor & transient.4

A separate study of

showed that 32% reported neck pain, 26% shoulder pain, 20% upper back pain, and 19% wrist and hand pain.5

Researchers from the University of Pennsylvania Perelman School of Medicine, School of Veterinary Medicine noted a

increase in opioid prescriptions for small animals over the past 10 years.

The study reviewed pharmacy records for 4 opioids prescribed for animals 2007 to 2017.

Prescriptions increased 41% annually over the study window, although the number of animal visits rose by only 13%. 20 states currently require veterinarians to report opioid prescribing to a central database.6

1. https://bit.ly/2C9j9t4 2. https://bit.ly/2SLRsw1 3. https://bit.ly/2UxffkU 4. https://bit.ly/2NP82dM 5. https://bit.ly/2EFun9o 6. https://bit.ly/2ES3X5q

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is not to add other traditional opioids to this opioid. When you mix methadone with traditional opioids, that’s when the pharmacokinetics and dynamics of two different opioids can cause trouble.

2

Drug Testing — What’s the Risk for Your Practice?

Jennifer Bolen JD

1

IV Methadone: When All Else Fails…

Annas Aljassem, MD Levi Hall pharmd, BCPS

Dr. Hall: Methadone definitely doesn’t have a sense of humor. I think as a practitioner, you have to not only understand the literature for methadone but also the limitations of what we know. It can be very unforgiving, and so really having a respect for those limitations when you’re dosing a patient can help push off some safety issues.

Dr. Aljassem: I definitely would agree that methadone needs to be respected. I think the other thing, though, is there is such a negative stigma about it that a lot of practitioners have kind of thrown their hands up saying, “I don’t understand it, so we’re not going to do it.” What we learn about are always the negatives: QT prolongation and excess sedation and respiratory depression. But we never learn about its amazing properties and the NMDA antagonism and everything that it potentially could do for patients when the traditional stuff hasn’t worked.

Dr. Aljassem: The indications for IV methadone would include when your traditional stuff has failed and you’re using hundreds or thousands of milligrams of oral morphine equivalents and your patient really can’t be transitioned to any other level of care. What do you do at that point? I know if I was the patient, I would want some outside the box type thinking. We’ve been very successful with outcomes in our populations using the IV methadone and eventually rotating them to p.o. methadone.

Dr. Hall: And then to further reduce their dose. It’s important to remember, when using methadone, to not dose adjust more than once a week. There are Department of Defense and Department of Veterans Affairs guidelines that talk about “methadone Mondays” as an easy way to remember how frequently you should adjust the dose. We ask patients to keep a pain diary and to keep track of how much medication they’re using so we can re-evaluate and do the appropriate dose adjustment when we see them in the office. Also, don’t neglect patient and family education about keeping medication locked up and out of reach.

Dr. Aljassem: I think that our biggest educational insight for primary care and caregivers of patients who are transitioned to IV methadone is that this is not like any other opioid. This is not like being on Dilaudid and oxycodone and morphine, and dose titration should not be done unless you have specialized training, unless you are coordinated with a pain specialist. Another point to remember

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Practitioners end up at risk in drug testing because they lack knowledge of the policies that payers put out on medical necessity.

They also can get into a lot of trouble if they don’t understand the mechanics of the clinical laboratory regarding presumptive testing and definitive testing. It’s important that the provider do due diligence before they get into any laboratory arrangement, whether it’s their own laboratory or with an independent laboratory. That’s where a lot of the cases have happened. In the last year there have been several lawsuits, criminal cases, and fraud investigations, and most of it relates to lack of knowledge of medical necessity and lack of proper documentation. There are ways to document medical necessity. The most important step that a provider can take is to understand what the state licensing board wants them to do regarding drug testing and then compare that with a carrier’s medical policy on drug testing. They can then create their own template so they can document what’s required of them on both sides—the licensing board and the payer—and tell them why this testing is being done for this patient and most importantly, how the test results are going to be used, and what we are doing for the patient as a result of the test. Primary care needs to understand that there are requirements for drug testing and that the frequency is not tied to their subjective perspective of whether the patient is at risk or not. It’s the fact that the patient is using an opioid, and that if they’re using the opioid chronically, that drug testing should be part of their risk management protocol. Practitioners should endeavor to look at their licensing board materials and medical policies to understand when they should order these tests and what should be documented.

3

Combatting the Biological Burden of Pain Emily Bartley, phd Kimberly Sibille MD, phd

Dr. Bartley: We know that chronic pain does have a biological interface. There are structural and functional changes in the brain, such as gray matter loss and a functional reorganization. We also know that chronic pain is associated with systemic effects, such as increased inflammation throughout the body such as IL-6 and c-reactive protein. Chronic pain also tends to increase stress reactivity, such as enhanced cortisol reactivity after the induction of some sort of a stressor.

Dr. Sibille: When we look at things like frequency, intensity, duration, and extent of pain, we’re better able to evaluate the effect on the system and it’s not only affecting the brain, as Dr. Bartley said, it’s affecting all the stress response systems. There is work showing that we can actually capture this and show that not only is there a burden from chronic pain on the system but, in fact, resilience factors which can buffer it. There are findings both clinically and

Q 2 | 2019

in population-based studies that I think are going to be encouraging to clinicians and patients and give us guidance for alternative treatments.

Dr. Bartley: These factors could be psychological such as positive affect or self-efficacy. They could be behavioral such as getting a good night’s sleep or having a good social relationship with your family and friends. There are existential factors such as having life purpose or acceptance. So there are multiple factors, which is really nice from an intervention sense because we can utilize multiple resources to enhance these various protective or resilience factors in people.

Dr. Sibille: All of those factors actually have a neurobiological/biological interface and so when we target resilience factors, we’re also hoping to enhance neuroplastic functioning and changes in the entire system. An additional piece: can we enhance or promote neuroplasticity? Can we optimize the body and the brain to be more responsive to these interventions? And particularly as we age, our metabolic and neurobiological functioning changes and yet there are some noninvasive strategies out there that might help us optimize to improve our learning and memory and response to treatment interventions. I think we’re starting to venture into some exciting areas that may help improve pain care and treatment.

think clinicians and others related to healthcare delivery have to do a couple of things: focus on what are the alternatives to opioids so that they have more in their armamentarium; become more vocal and demand that we retain the ability to practice and take care of our patients in ways that we control and oversee. We should be trying to make the case to insurers and other payers in our system that some of the best evidence for treatment of chronic pain is multidisciplinary care, nonmedication therapies, and coordinated care, all of which the health insurer or payer should be interested in because ultimately if the patient has a better outcome, the cost of care will be less. When you’re thinking about how to create a coherent system of care, you do want some top-down influence. You want some regulations, you want some oversight, you want there to be mechanisms to address the public concerns and the epidemiology of patient care. But you can never forget that patient care really is a one-on-one enterprise—it’s a practitioner and their patient.

5

Sleep and Pain in Older Adults — Looking for a Better Way to Treat Robert Raffa phd

4

Building Prescribers’ Confidence

Michael Clark MD, MPH, MBA

Practitioners have been outspoken in describing how they feel a lack of confidence in their own abilities to use opioids, in who to use them, and how to use them. If you couple that with their lack of knowledge about the alternatives to opioids, you really have a situation that is bound to fail because you won’t have the capability to tailor treatment to the individual patient. When you think about who you’re going to be prescribing opioids to, of course there’s going to be legitimate patients and there are going to be other patients that don’t do as well—the person who’s noncompliant or a high utilizer of healthcare or even very demanding of your services in a way that makes you feel out of control in the care of that patient. We’ve learned that opioids are not a panacea and that the eradication of pain is in most cases impossible, and certainly not the only goal. While it would be nice to have people painfree, what we’re really faced with is helping people to be functional despite some level of pain. We all have a variety of physical burdens that we have to struggle with each day, particularly as we all get older, and yet most of us are able to remain functional in ways that are satisfying. So, in prescribing whatever medication, the practitioner now has to ask if the patient is more functional than they were before that medication. If they’re not, then they need to think about whether the medicine should be changed or whether other therapies should be engaged. I think the clinical community should recognize that opioids have been overused and have not been used in a precise manner. As a result, society and its regulatory agencies are now scrutinizing us and starting to limit our ability to care for our patients in the way we might want to. Guidelines have many problems, in part because they really can’t offer the specificity for how to manage an individual patient. They are general, and they are meant to be broad. They serve a role in terms of helping to educate providers, but they fail us when they then are used to constrain our ability to practice and to treat the individual patient. So, I

Q 2 | 2019

Chronic pain patients tend to be a little older and that in and of itself leads to a decrease in quality of sleep. Loss of quality sleep makes the pain seem a little worse and more difficult to deal with.

So how can we treat both pain and sleep issues to break that cycle?

And to make matters even more complicated, some of the drugs used to treat chronic pain, such as the opioids, have a deleterious effect on quality of sleep. The benzodiazepines work at a special receptor that’s on a much larger receptor, and the mechanism of action is well defined. It increases the activity of the gaba-A receptor and that decreases the reactiveness, I’ll say, of neurons, and that’s why the benzodiazepines are so good for anxiety. They don’t decrease the nerve’s physiology, but what they do is make that nerve less likely to overreact. They also calm a person, allowing them to sleep a little better. Unfortunately, they have their own downsides when they’re used in combination with other central nervous system depressants, like opioids. The FDA has come down pretty strongly against the concomitant use of benzodiazepines plus opioids. There are some newer nonbenzodiazepine chemical drugs, sometimes called the Z drugs or the Z plus C drugs, but pharmacologically, they work the exact same way the benzodiazepines do. They’re a little safer, but still not the answer. Some other approaches involve the melatonin mechanism, our natural way of falling asleep and getting good rest. We’re looking at how does the body normally have restful sleep? So, you tend to look for the neurotransmitters that might be involved. A lot of times you don’t want to take traditional antihistamines because they make you a little drowsy. But if used properly in the right patients and at the right time of day, it could actually be pretty beneficial and could be a way to get away from the benzodiazepines. Clinicians should hear what FDA is saying about benzodiazepines, but also should not forget that their patients with pain need help with what is almost certainly going to be some adverse effect on their quality of sleep.

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with

gary w.

jay

md, faapm

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“I will always look for ways to do something clinically to help patients who have failed ‘book determined’ pain treatment.”

Q

What inspired you to do what you do?

a

I was always interested in the complexity of the human brain. To me it is the most fascinating and mysterious organ in the body. It controls so much! After doing some undergraduate work in the neurochemistry of memory, I was drawn into both medicine and research. I started an md/phd program at Northwestern University in Chicago, and then realized that I could do all the research I wanted with just the md. Since I was putting myself through school, saving a couple of years was nice! I was always enamored with the central nervous system, and the more I learned the more I realized that, in neurology, while we could treat symptoms, there were really minimal things that could be done to truly help deal with major issues.

That’s when I “discovered” headache and pain and the fact that I could significantly help those patients. I was hooked into pain medicine in the 1970s, way before it was a subspecialty.

Q

a

Why did you focus on pain management?

As noted above, I was sort of disappointed in the ability of neurologists in the 1970s to “fix” anything. That hasn’t really changed, but what we can do now for multiple sclerosis and Parkinson’s disease, as well as other neurological disorders, is incredible. When I was an intern, one of my students introduced me to her father, who was a well-known headache specialist. I got involved with the American Association for the Study of Headache, and I realized there was far more to neurology than was taught in medical school, which didn’t really deal with headache or pain. I made that a focus for myself and even as a resident dug

Q 2 | 2019

into what I could in both areas. I studied everything I could and when I finished my residency my first job was with one of the two top headache gurus in the country. Then I got more into pain. I was one of the 30 founders of the American Academy of Pain Medicine (formerly Algology) in 1983. Five years later, I was one of 8 folks who helped form the American Academy of Pain Management. What was different? The American Academy of Pain Medicine didn’t think nonphysicians mattered, which of course was total bologna (to put it nicely).

The bottom line is that I became a pain medicine specialist as well as a headache specialist, which now just isn’t done. Doctors are either one or the other. I still do both.

Q

Who were your mentors?

a

My mentors were some of the absolute headache greats: John Edmeads, Arnold Friedman, Lee Kudrow, Neil Raskin, John Graham, Jim Dexter, and more. Probably one of my most incredible pain mentors was Joan “Rocky” Graziano, pt, who started the first interdisciplinary pain center at Walter Reed Hospital before I started my first interdisciplinary neuro-rehab center.

Another incredible physician and mentor was Dr. Janet Travell.

Q If you weren’t a healthcare provider, what would you be?

a

If I wasn’t helping patients as a physician, I’d only be working in drug development. On the other hand, I could have become a full-time author, if there weren’t more important things to do— like feed my family.

www.painweek.org | PWJ

67

short cuts

Q

What is your most marked characteristic?

a

Probably it would be my stubbornness (see my motto). I will always look for ways to do something clinically to help patients who have failed “book determined” pain treatment. I will do whatever I have to do, including utilizing medications off label as needed, to help patients. I am nothing if not inventive. I was also one of the first pain docs who didn’t use opioids as the primary pain drug for patients, at least not after other types of medications, like helpful anticonvulsants, were around. Dilantin was there when I was starting out. So were other similar medications.

It was just that the majority of physicians used acms for seizures. Period. I didn’t.

Q What do you consider your greatest achievement?

a

For me, to quote Frank Sinatra, “I did it my way.” I left home when I was 15 and put myself through college and then my medical training. I was one of the first to start a privately owned interdisciplinary neuro-rehab headache and pain center west of the Mississippi in 1980. After 26 years of running this center, in 3 states, I spent 12 years in pharma. As Chief Medical Officer of one company, I helped bring a formulation of intranasal fentanyl through the fda; the medication was used for breakthrough pain in cancer. I will never forget the feeling the first time I prescribed this medication for a cancer patient. I really had helped not a single patient, but hundreds of thousands, if not more.

I’ve also had the honor to be politically active. I was president of a state pain organization (the Florida Academy of Pain Medicine); a regional organization (the Eastern Pain Association, which was, per its bylaws, encompassing the Eastern Seaboard) and a national organization (the American Academy of Pain Management).

I think it is wonderful that I have been able to teach many folks, by lecturing, with 5 published textbooks, and over 170 mostly peer-reviewed journal articles.

68 PWJ | www.painweek.org

Q

What is your favorite language?

a

By default, English. Guess that’s my fault!

I also know a bit of Yiddish and a bit of Chinese.

Q If you had to choose one book, one film, and one piece of music or art to take into space for an undetermined amount of time, what would they be?

a

Book: The Lord of the Rings trilogy (OK, maybe I cheated) Film: Possibly Rudy (1993)

Music: A Genesis anthology or an Alan Parson’s anthology; possibly Dark Side of the Moon (Pink Floyd) or an Andrew Lloyd Webber anthology.

I’ve never fallen in love with just one music group—then again, maybe Within Temptation or Nightwish (I love symphonic metal)

Q

What would you like your legacy to be?

a

That I helped a bunch of people with a life-changing effect and, equally important, taught more physicians to do the same.

Q

Plans for the future?

a

I will remain as a Clinical Professor at the University of North Carolina Department of Neurology at least part time. I will also work to achieve the one thing I have never done: start my own pharmaceutical company and develop a nonopioid strong analgesic.

Q

What is your motto?

a

There is always more than one way to skin

a rat!

Gary W. Jay, md, faapm, is a Clinical Professor at the University of North Carolina in the Department of Neurology, in Chapel Hill.

Q 2 | 2019

2019

September 3â&#x20AC;&#x201D;7

September 3â&#x20AC;&#x201D;7

elebrating our 13th year, PAINWeek remains the largest US pain conference and the favorite destination for frontline practitioners to enhance their competence in pain management.

5 Days, 120+ Hours, and 90+ Faculty In 2019, you can look forward to a week of Special Interest Sessions, Master Classes, Multidisciplinary Course Concentrations, Satellite Events, and Exhibits.

To learn more and register for PAINWeek 2019, visit www.painweek.org and follow us on TwitterÂŽ at twitter.com/painweek.

N W ew

orkshops!

Innovations in Pain Medicine Ultrasonography:

Image Guidance, Diagnosis, and Emerging Applications Jennifer Hah MD, MS Einar Ottestad MD Presented Tuesday, September 3 1:40p – 5:40p Registration Fee: $350 The field of pain medicine ultrasonography is continually evolving with utility in image guidance, diagnosis or pointof-care assessment, and treatment. Around the world, pain medicine specialists favor the use of ultrasound guidance for its accuracy, portability, direct visualization of vasculature, and decreased radiation exposure. In addition, emerging applications continue to evolve for pain medicine sonography with new developments in peripheral nerve stimulation and regenerative medicine. This hands-on session will cover the latest evidence-based rationale for ultrasound image guidance for interventions vs other modalities including fluoroscopy and CT-guidance. An introduction to diagnostic ultrasonography will be presented covering common pain conditions. Emerging applications for pain medicine ultrasonography particularly relating to peripheral nerve stimulation, regenerative medicine, cryotherapy, and radiofrequency will be discussed.

Hitting the Bull’s Eye in Pain Management:

Using All the Arrows in Your Quiver Alexandra L. McPherson pharMD, Mph Mary Lynn McPherson pharMD, Ma, MDE, BCpS Presented Wednesday, September 4 9:30a – 12:30p Registration Fee: $165 Rarely is one medication or pharmacologic class of drugs the answer to a medical conundrum, including in pain management. While opioids are indisputably valuable in treating acute pain and some forms of chronic pain, they are just one therapeutic option. Participants in this fast paced, case-based session will learn about the appropriate use of different medications in lieu of, or in combination with, opioid therapy. Along the way we will explore contemporary issues in pain management such as the positive and negative implications of gabapentinoid plus opioid therapy, specific evidence that supports the use of cannabinoids in the management of chronic pain (and does it reduce opioid burden?), and other controversial issues.

Participants will learn how to deal with difficult pain syndromes including wound pain, complicated neuropathic pain, and functional pain syndromes. Lastly, we will wrestle with cases that illustrate the need to deploy interventional pain management strategies instead of, or in addition, to opioid therapy. Bring your seat belt: this is going to be a crazy ride!

Rotate the Molecule!

Rationalizing Excessive Opioid Prescribing With Buprenorphine Douglas L. Gourlay MD, MSC, FrCpC, FaSaM Presented Wednesday, September 4 1:40p – 4:40p Registration Fee: $165 Buprenorphine is a partial mu agonist that has been clinically available for many years. It was recently made available for the treatment of opioid dependency in the office-based setting. Even more recently, it is enjoying a renewed popularity as an opioid analgesic for the treatment of chronic pain. In this workshop, attendees will explore problematic and sometimes excessively high opioid prescription levels in the context of a treatable clinical condition; case-based examples will be provided.

The basics of buprenorphine pharmacology, clinical utility, and the regulatory status of a variety of currently available preparations will be examined through the prism of current as well as past peer reviewed literature. Participants will gain a better understanding of initiation, stabilization, maintenance, and exit strategies.

F

eatured

S

essions

Inside the Trojan Horse:

Addressing Current Legal Actions Against Healthcare Practitioners Jennifer Bolen JD Douglas L. Gourlay MD, MSC, FrCpC, FaSaM Using case examples, this course will address the insider’s view to illustrate the connection between carrying out licensing board directives on using opioids to treat pain, reasonably prudent medical decisionmaking, and documentation. The content presented is designed to engage participants who will work through several short case examples with faculty, all of whom are experienced as medical and legal experts. These case examples will cover patient history and risk evaluation; treatment plans including treatment goals and exit strategies; true informed consent and treatment agreements; follow-up encounters and risk monitoring, including the use of prescription drug monitoring databases, drug testing, and adjustments to the treatment plan; and use of consultations and referrals. Attendeeswill learn about current trends in medical expert assessment of prescribing decisions and how to improve documentation of medical decision-making and opioid prescribing decisions. This session is a must-attend for Main Street Practitioners!

The World According to Cannabinoids Theresa Mallick-Searle MS, np-BC, anp-BC Ethan B. Russo MD

Despite the widespread acceptance of medicinal and recreational cannabis use internationally and domestically, marijuana remains federally illegal in the United States.

For this reason, there are significant legal implications to clinical practice. Clinicians are unprepared to answer questions regarding legality or safety of cannabis use and unprepared to counsel their patients on use or abstinence, particularly for pain management. This session will explore legal implications, discuss current science, and define the scope of the problem related to the need for education about risk and safety of counseling patients about cannabis use. Case examples will be presented.

The Static Pendulum: Pain, Drugs, and Ethics Kevin L. Zacharoff MD, FaCIp, FaCpE, Faap

Pain remains one of the most common reasons that people seek medical attention in the United States. When pain was designated as the fifth vital sign, people were given the right to have their pain assessed and effectively treated by their healthcare professionals. A number of ethical dilemmas have surfaced since, including the increased prescribing of opioid medications for patients with chronic pain in the face of also increasing rates of abuse, misuse, and addiction related to these medications. The “opioid overdose epidemic/crisis” has led us to the challenge of balancing the safe, compassionate, and effective treatment of chronic pain against serious negative outcomes associated with the increased abuse and misuse of these medications. With overdose death rates increasing, tensions running high, a multitude of political and regulatory involvement, and “knee-jerk” reactiveness, it seems as if the only thing being forgotten is the needs of chronic pain patients and the core ethical principles intended to help clinicians maintain the highest standards of care. This session will describe these principles and clarify their role in determining reproducible courses of action that maximize safety, efficacy, and compassionate pain care, regardless of the direction the “opioid pendulum” is swinging.

Lost in the Weeds:

The Past, Present, and Future of Hemp in Pain Treatment Stephen J. Ziegler phD, JD Marijuana and hemp are genetically distinct cousins of the genus Cannabis sativa L., yet they have been erroneously associated with each other for the past 80 years. That all changed in December 2018 when Congress removed hemp from the federal Controlled Substances Act (CSa) and legalized the plant and its derivatives such as cannabidiol (CBD), a substance which has received a great deal of attention for its potential to treat a variety of medical conditions. This change is historic and has enormous

implications in medicine and the treatment of pain. However, although the oversight of hemp has essentially been transferred from the DEa to the USDa and individual states, the FDa still retains its authority “to regulate products containing cannabis or cannabis-derived compounds” such as CBD. Accordingly, in an effort to inform healthcare professionals about this rapidly changing field, this presentation will discuss the history of hemp, its legality, derivatives, and its potential future in pain treatment.

Everybody’s Greasing Up, But Should You Rub It In?

A Review of Topical Analgesics and Available Evidence in Clinical Trials Timothy Atkinson pharMD, BCpS, CpE

Topical analgesics are often recommended in clinical practice but differences between formulations and routes of administration lead to confusion. In addition to commercially prepared topical analgesics, compounded topical analgesics are highly promoted and widely utilized from compounding pharmacies with individualized recipes of multiple combined medications at substantial cost. To assist providers with tough decisions in this area, the available clinical trials supporting use will be reviewed along with formulations, locations, and doses where their use has been shown to the be most effective. This session will review the role of various topical analgesics as well as explore the rationale for “topical polypharmacy” with compounded drugs.

The Golden Girls Dilemma:

Genitourinary Syndrome of Menopause(gSM) Georgine Lamvu MD, Mph

Genitourinary syndrome of menopause (gSM) is a term used to describe what was formerly known as vaginal atrophy, atrophic vaginitis, or urogenital atrophy. The older terminology was replaced by this descriptive term with the goal of more accurately describing the constellation of symptoms experienced by gSM patients, including vaginal pain, dryness, dyspareunia, urinary incontinence, urgency, frequency, hematuria, and sexual dysfunction. Although gSM-like symptoms occur in 15% of premenopausal women and 40% to 54% of postmenopausal women, the condition is associated with significant social stigma and often remains ignored or underdiagnosed. This presentation will review the clinical manifestations, pathophysiology, etiology, evaluation, and management of this condition. Specific emphasis will be placed on differentiating gSM from other genital pain conditions such as vulvodynia and vulvar dermatoses. Additionally, the presentation will review the impact of postmenopausal pain on quality of life, mental and physical health, and sexual function. Treatment recommendations will focus on multimodal therapies to address what is a complex but treatable syndrome. The importance of early detection and patient education in avoiding long-term risks and complications that compromise quality of life will also be discussed.

Agenda

For planning purposes, please note that the first certified-for-credit course begins on Tuesday, September 3, at approximately 7:00a. The last certified-for-credit course concludes on Saturday, September 7, at 4:30p.

Monday

■

Presented from 6:00p – 7:00p

PAINWeek 101*

9.2

● Making the Most of Your PAINWeek Experience!

PAINWeek 101 is a noncertified primer for first time attendees—or anyone seeking a refresher on the conference agenda, faculty, onsite technology, and venue logistics. Moderated by PAINWeek staff and faculty, with Global Education Group, all questions as they pertain to course selection and CME protocol will be answered. With so much packed into the 5-day conference, PAINWeek 101 will make sure that you’re fully briefed and oriented to navigate, plan, select, and make the most of your PAINWeek experience!

Interventional Pain Management ● Dorsal Root Ganglion:

Neuromodulation as an Alternative to Opioids

● Injections, Nerve Blocks, Pumps, and Spinal Cord Stimulation ● Spinal Stenosis:

Epidemiology, Pathophysiology, and Treatment

● Neuromodulation for Advanced Practice Providers ● Stem Cells and Regenerative Medicine for Chronic Pain ● Interventional Pain Management: Opioid Sparing Technologies

Not certified for credit.

Special Interest Sessions

Tuesday

■

Sessions presented from 7:00a – 6:30p

Behavioral Pain Management

● Insight into Preclinical Drug Discovery and Translational Medicine

9.3

● Moving Beyond the Obvious:

The Pivotal Role of Psychology in Pain Management

● Icebergs, Oceans, and the Experience of Pain ● The Death of Caesar:

Psychological Stages of Grief and Chronic Pain

● Lip Service:

Using Words as the Foundation for Effective Pain Management

● Pain Catastrophizing:

Making a Mountain Out of a Mole Hill

Chronic Pain Syndromes ● Not Tonight:

Headache & Sex Hormones

● Hanging by a Thread: Facial & Orofacial Pain

● Neck and Upper Extremity Pain Syndromes ● Neurogenic Thoracic Outlet Syndrome

● Status Traumaticus:

A Trauma Informed Approach to Chronic Pain Management

● The World According to Cannabinoids: Clinical and Research Updates

● The Gang that Couldn’t Shoot Straight: Reconsidering the CDC Guidelines

● Salt of the Earth:

The Importance of Sodium Channels in Pain Management

● Geriatric Pain Management: Minimally Invasive Interventions

● Malpractice for Dummies:

Getting Sued and Surviving to Talk About It

● Eyes Without a Face:

Pain Management for Those Living With Alzheimer’s Disease

● Chapter None:

Patient-Centered or Paper-Centered Pain Management?

● Follow the Yellow Brick Road: Reducing Clinician Burnout

NeW Workshop ● Innovations in Pain Medicine Ultrasonography:

Image Guidance, Diagnosis, and Emerging Applications

Wednesday 9.4

■

Sessions presented from 7:00a – 6:30p

Acute Pain Management

NeW Workshops

● Acute Pain in Patients With Active Substance Use Disorder

● Hitting the Bull’s Eye in Pain Management:

● The Dynamics of Managing Acute Postoperative Pain in the Current Opioid Sparing Environment

● Rotate the Molecule!

● Case-Based Challenges in Acute Pain Management ● Enhancing Recovery After Surgery: How Certified Nurse Anesthetists Are Improving Outcomes

International Pelvic Pain Society (IPPS)

Using All the Arrows in Your Quiver

Rationalizing Excessive Opioid Prescribing with Buprenorphine

Keynote ● Are the Monsters Coming to Main Street?

Welcome Reception/Exhibit Hall Opening* *Not certified for credit.

● The BIG BANG of Pain:

Chronic Overlapping Pain Conditions in Women

● The Force is With You:

Mind Tricks for Chronic Pain Patients

● Let’s Get Physical!

Musculoskeletal Pelvic Pain

● The Golden Girls Dilemma:

Genitourinary Syndrome of Menopause gSM

Medical /Legal ● Inside the Trojan Horse:

Addressing Current Legal Actions Against Healthcare Practitioners

Pain Educators Forum ● Pain Terminology:

Knowing the Difference Makes a Difference!

● Pain Pathways Made Simple ● Chronic Pain Assessment ● Clinical Pearls:

Unraveling the Secrets of Imaging Studies

● Pain Therapeutics

Special Interest Sessions ● Causalytics: You’re in Pain, and It’s All Your Fault ● How Healing Works, and What it Means for Chronic Pain Management ● Preventing a Benzodiazepine Crisis and Understanding Protracted Withdrawal Syndrome ● Psych Twister: Using Metaphors, Mindfulness, and Values to Promote Behavioral Change

● Maleficent Morphine Milligram Equivalents & Dosing Dilemma Disasters ● Pain Management Coaching

“PAINWeek is by far the best and most diverse educational and networking opportunity in the field.”

— R. N

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9.5

■ hursday

Sessions presented from 7:00a – 6:30p

Advanced Practice Providers

Pain Educators Forum ● Life Hacks to Teach Chronic Pain Patients

● Medication Assisted Therapy: New Opportunities in Treatment

● Navigating the OTC Analgesic Aisle:

● No Guts, No Glory:

What a Pain in the Aspirin!

Mystery of the Microbiome

● The Curbside Consult in Management

● Achieving Change from Within: Use of Motivational Interviewing

● Through the Eyes of an Expert Witness: The Importance of Chart Documentation

● Red Rover, Red Rover, Send Pain Patients Right Over: Patient Engagement in Multimodal Care Plans

● Spilled Beans and Hard Stops:

● Starting an Acute Pain Service

American Headache Society (AHS) Chronic Migraine Education Program (CMEP) ● Diagnosis of Chronic Migraine and Episodic Migraine

How Legislation, Guidelines, and Reimbursement Policies Impact Patient Care

Pharmacotherapy ● Which Came First…

Pain or Substance Use Disorder?

● Transitions, Risk Factors, and Barriers to Care ● Pathophysiology of Chronic Migraine and Episodic Migraine ● Acute and Preventive Treatment Strategies

● Kratom or Bait ’em?

Understanding the Pharmacology of Kratom

● Mirror, Mirror on the Wall…

Who’s the FDA’s Fairest ADF of All?

● Putting the “FUN” in Dysfunctional: Pain Management Options in Renal and Hepatic Dysfunction

Master Class ● Blinded by the Light:

The Danger of Idiopathic Intracranial Hypertension

Special Interest Sessions ● Buprenorphine:

Medical/Legal

A Molecule for All Seasons

● A New Leaf:

A Legal and Medical Perspective on Marijuana Use When Prescribing Controlled Substances

● The Static Pendulum: Pain, Drugs, and Ethics

● Understanding Analgesic Trials ● Back to the Future:

Current and Future Opioid Abuse Risk Assessment and Mitigation Strategies

“PAINWeek is what every pain conference wants to be… what every pain conference — should be!”

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an

● The Elephant in the Room:

Helping Patients to Navigate the “O” Impasse

● Central Sensitization and Ketamine ● Deuces Wild:

Fudin & Gudin Argue the New Rules of the Game

ph

d, c

● Alcohol As Analgesia:

pe

,d as p

e

Does it Really Numb the Pain?

Scientific Poster Session and Reception* *Not certified for credit.

F

■ riday

Sessions presented from 7:00a – 6:30p

9.6

Cannabinoids and Medical Marijuana

Special Interest Sessions

● Lost in the Weeds:

● Medical Stasi:

● Reefer Madness Madness:

● The Cracked Mirror:

The Past, Present, and Future of Hemp in Pain Treatment Taking the Insanity Medical Cannabinoids

● Medical Marijuana:

The Standardization Proclamation and Its Consequences Exploring Opioid Abuse Deterrent Methods from Lab to End User

Psychiatric and Medical Conditions With Specific Attention to Chronic Pain

● The Visible Few:

● The Global Legalization of Marijuana:

● Managing Opioid Withdrawal and Overdose With Alternative Treatment Options

● Cannabis and Opioids Together: Syn or Synergistic?

● Applying Mechanism-Based Classification to Clinical Reasoning for Complex Persistent Pain

Master Classes

● Analgesics of the Future

A Reasonable Solution to Treat Pain…or a Pipe Dream?

● Back Pain:

It's All About the Diagnosis

Medical /Legal ● I’m Not a Doctor, But I Play One in DC

An Imperfect Burden on Patients and Providers

● Opioid Moderatism: Seeking Middle Ground

Exhibit Hall Closing Reception* *Not certified for credit.

Neurology ● An Elusive Villain:

Pain Associated With Lyme Disease and Other Spirochetal Infections

● When Darkness Falls:

Managing Pain in Fibromyalgia and Restless Leg Syndrome

● The Spider’s Strategem: Arachnoiditis

● Not Glad All Over:

Chronic Widespread Pain

Pharmacotherapy ● Everybody’s Greasing Up, But Should You Rub It In?

A Review of Topical Analgesics and Available Evidence in Clinical Trials

● Opioid Math Conversions:

Calculations, Titrations, and Breakthroughs

● He SAID, She SAID.

What’s the Deal with NSAIDs?

● Thug Drugs…

Revisited

“PAINWeek is the premier interdisciplinary pain management conference for frontline practitioners and the leading edge of science in — pain medicine.”

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Saturday

■

Sessions presented from 7:00a – 4:30p

Encore Presentations

9.7

● Pain Pathways Made Simple ● Clinical Pearls:

Unraveling the Secrets of Imaging Studies

International Myopain Society (IMS) ● Transformative Care for Myopain:

Enhancing Long-Term Success in Myofascial Pain and Fibromyalgia

Medical/Legal ● Embrace Changes and Prevent Overdose: A Basic Blueprint for Legal Risk Mitigation and Response

● Get Your Specimens in Order: Timely Use of Test Results

Palliative Care ● That’s Debatable! Does Cannabis Reduce Opioid Death, and Does Gabapentin Increase It? ● Addressing the Pain While Dressing the Wound ● You’re Using WHAT for Pain Management?

Psilocybin, Ecstasy, and Ketamine

Special Interest Sessions ● Let’s Get on the Same Prescribing Page:

Standardizing Opioid Prescribing Practices Among Sickle Cell Disease Patients

● Acupuncture for Opioid Use Disorder ● An Integrative Pain Management Program: What Does a Multimodal Program for Chronic Pain Look Like?

● Improving Safety of Chronic Opioid Prescribing by Incorporating Clinical Pharmacists on Teams

Veterans Health Administration (VHA) ● Moving Mountains:

Shifting the Pain Management Paradigm

● VA’s Stepped Care Model for Pain Management and Whole Health:

Patient Centered Biopsychosocial Pain Care

● Opioid Therapy and Opioid Tapering— Guidance for Clinicians to Improve Outcomes: A Case-Based Pro/Con Discussion Format

● Opioids and Mental Health:

Suicide Prevention as Highest Priority

● Doing Business or Risky Business?

Benzodiazepines and Opioids in Palliative Care

Pharmacotherapy

Please note: faculty and courses are subject to change.

● Better With Age?

Pain Management of the Older Adult

● Testing the Waters:

Urine Drug Screening for the Perplexed Among Us

● Frankie says RELAX:

The INs and OUTs of Skeletal Muscle Relaxants

Accreditation Over 120 hours of content will be presented! This activity is provided by Global Education Group. Global Education Group is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Global Education Group designates this live activity for a maximum of 39.0 AMA PRA Category 1 Credits™.

This activity will be approved for continuing pharmacy, psychology, nurse practitioner, and nursing education.

Applications for certification of social work nasw and family physician aafp hours have been applied for and are pending decision. For more information and complete cme/ce accreditation details, please visit our website at www.painweek.org.

2019 Discount Expiration Dates for Practicing Healthcare Professionals:

................

July 31 .................. $799 Full Fee ...............$879

(After July 31)

Industry registration is $979.

Please note that workshops for PAINWeek 2019 require additional registration fees.

.....................

Registration Options Visit: www.painweek.org Call: toll free (877) 724â&#x20AC;&#x201C;6933

Hotel Information The Cosmopolitan of Las Vegas 3708 S Las Vegas Boulevard Las Vegas, nV 89109 Conference rate $165 + tax per night.

This rate is applicable to healthcare providers only, and can only be guaranteed if reserved

by July 29, 2019.

Please note: You will receive hotel booking information upon completion of your conference registration.

Be there or be

Register Now September 3â&#x20AC;&#x201D;7 2019 www.painweek.org

The Cosmopolitan of Las Vegas