PWJ - PAINWeek Journal Vol 9, Q2 | 2021

vol. 9 q 2 2021

rules of the game: dea guidelines for controlled substance documentation and treatment actions p.18 always be closing: what’s the right sales pitch for active strategies in pain care? p.28 what wires together, fires together: integrative and complementary strategies for complicated pain p.36 comorbid painful hypermobile ehlers danlos & orthostatic postural tachycardia p.42

PAINWEEK’21 CONFERENCE PREVIEW P.74

FOR ADULT CHRONIC NON-CANCER PAIN (CNCP) PATIENTS WITH OPIOID-INDUCED CONSTIPATION (OIC)

Take a proactive approach to OIC with RELISTOR ®

RELISTOR helps to restore gut function by increasing the frequency of SBMs1,* In a clinical trial of adult patients with OIC and CNCP, 52% of patients (n=200) taking RELISTOR tablets experienced at least 3 SBMs* per week, with an increase of at least 1 SBM(s) per week over baseline, for 3 or more of the 4 week treatment period vs 38% of patients (n=201) receiving placebo (P=.005).1,2

STUDY 1: In a 4-week, randomized, double-blind, placebo-controlled, phase 3 study, the efficacy of RELISTOR tablets was evaluated in 401 patients (200 RELISTOR tablets, 201 placebo) with CNCP for which they were taking opioids. All patients had OIC, defined as <3 SBMs per week and at least one additional symptom of constipation.1,2

*SBM (spontaneous bowel movement) is defined as bowel movement without the use of any laxative in previous 24 hours.1

INDICATIONS • RELISTOR® is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

• RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

IMPORTANT SAFETY INFORMATION • RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

• Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

• If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

• Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.

• Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

Please see Brief Summary of full Prescribing Information for RELISTOR following this advertisement.

The only 2 routes for adults with CNCP1,3-6 The OIC firsttreatment and only with PAMORA withof2administration routes of administration for CNCP RELISTOR tablets: A once-daily, oral treatment at home.1 • RELISTOR tablets should be taken with water on an empty stomach at least 30 minutes before the first meal of the day1 • RELISTOR therapy should be continued only during opioid use. Re-evaluate the need for RELISTOR if the opioid regimen is changed to avoid adverse reactions1

RELISTOR subcutaneous injection RELISTOR injection is the only product indicated to treat OIC in adults with advanced illness or active cancer pain who require opioid dosage escalation for palliative care.1,3-5

LEARN MORE AT RELISTORHCP.COM

IMPORTANT SAFETY INFORMATION (continued) • The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

• A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.

• A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions and dose adjust per Prescribing Information as may be indicated.

• In the clinical studies, the most common adverse reactions were: OIC in adult patients with chronic non-cancer pain – RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).

– RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).

• OIC in adult patients with advanced illness – RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Brief Summary of full Prescribing Information for RELISTOR following this advertisement.

REFERENCES: 1. RELISTOR [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Data on file. Clinical study report MNTX3201. Salix Pharmaceuticals; 2015. 3. AMITIZA (lubiprostone) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America, Inc; 2012. 4. MOVANTIK® (naloxegol) [prescribing information]. Raleigh, NC: RedHill Biopharma Inc; 2020. 5. SYMPROIC® (naldemedine) [prescribing information]. Raleigh, NC: BioDelivery Sciences International, Inc; 2020. 6. Pergolizzi JV Jr, Christo PJ, LeQuang JA, Magnusson P. The use of Peripheral μ-Opioid Receptor Antagonists (PAMORA) in the management of opioid-induced constipation: an update on their efficacy and safety.

Drug Des Devel Ther. 2020;14:1009-1025. doi:10.2147/DDDT.S221278

www.salix.com 400 Somerset Corporate Boulevard, Bridgewater, NJ 08807 Tel 800-321-4576 Relistor is a trademark of Salix Pharmaceuticals or its affiliates. © 2021 Salix Pharmaceuticals or its affiliates.

RELO.0027.USA.21

BRIEF SUMMARY OF PRESCRIBING INFORMATION This Brief Summary does not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR (methylnaltrexone bromide) 150 mg tablets, for oral use.

RELISTOR (methylnaltrexone bromide) injection, for subcutaneous use.

8 mg/0.4 mL methylnaltrexone bromide in single-dose pre-filled syringe.

12 mg/0.6 mL methylnaltrexone bromide in a single-dose pre-filled syringe, or single-dose vial. Initial U.S. Approval: 2008 1 INDICATIONS AND USAGE 1.1 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

1.2 Opioid-Induced Constipation in Adult Patients with Advanced Illness RELISTOR injection is indicated for the treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

4 CONTRAINDICATIONS RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS 5.1 Gastrointestinal Perforation Cases of gastrointestinal perforation have been reported in adult patients with OIC and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom [see Contraindications (4)].

5.2 Severe or Persistent Diarrhea If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

5.3 Opioid Withdrawal Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR [see Adverse Reactions (6.1)]. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia.

Take into account the overall risk-benefit profile when using RELISTOR in such patients. Monitor for adequacy of analgesia and symptoms of opioid withdrawal in such patients.

6 ADVERSE REACTIONS Serious and important adverse reactions described elsewhere in the labeling include: • Gastrointestinal perforation [see Warnings and Precautions (5.1)] • Severe or persistent diarrhea [see Warnings and Precautions (5.2)] • Opioid withdrawal [see Warnings and Precautions (5.3)] 6.1 Clinical Trials 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 clinical practice.

Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain The safety of RELISTOR tablets was evaluated in a double-blind, placebocontrolled trial in adult patients with OIC and chronic non-cancer pain receiving opioid analgesia. This study (Study 1) included a 12-week, doubleblind, placebo-controlled period in which adult patients were randomized to receive RELISTOR tablets 450 mg orally (200 patients) or placebo (201 patients) [see Clinical Studies (14.1)]. After 4 weeks of double-blind treatment administered once daily, patients continued 8 weeks of doubleblind treatment on an as needed basis (but not more than once daily).

The most common adverse reactions in adult patients with OIC and chronic non-cancer pain receiving RELISTOR tablets are shown in Table 4. Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal.

Table 4: Adverse Reactions* in 4-Week Double-Blind, PlaceboControlled Period of Clinical Study of RELISTOR Tablets in Adult Patients with OIC and Chronic Non-Cancer Pain (Study 1). Adverse reactions for RELISTOR Tablets (n=200) and Placebo (n=201) were abdominal pain** (14% v.10%), Diarrhea (5% v. 2%), Headache (4% v. 3%), Abdominal Distention (4% v. 2%), Vomiting (3% v. 2%), Hyperhidrosis (3% v. 1%), Anxiety (2% v. 1%), Muscle Spasms (2% v.

1%), Rhinorrhea (2% v. 1%), Chills (2% v. 0%). * Adverse reactions occurring in at least 2% of patients receiving RELISTOR tablets 450 mg once daily and at an incidence greater than placebo. ** Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort and abdominal tenderness.

The safety of RELISTOR injection was evaluated in a double-blind, placebocontrolled trial in adult patients with OIC and chronic non-cancer pain receiving opioid analgesia. This study (Study 2) included a 4-week, doubleblind, placebo-controlled period in which adult patients were randomized to receive RELISTOR injection 12 mg subcutaneously once daily (150 patients) or

placebo (162 patients) [see Clinical Studies (14.1)]. After 4 weeks of doubleblind treatment, patients began an 8-week open-label treatment period during which RELISTOR injection 12 mg subcutaneously was administered less frequently than the recommended dosage regimen of 12 mg once daily.

The most common adverse reactions in adult patients with OIC and chronic non-cancer pain receiving RELISTOR injection are shown in Table 5. The adverse reactions in the table below may reflect symptoms of opioid withdrawal.

Table 5: Adverse Reactions* in 4-Week Double-Blind, Placebo-Controlled Period of Clinical Study of RELISTOR Injection in Adult Patients with OIC and Chronic Non-Cancer Pain (Study 2). Adverse reactions for RELISTOR Injection (n=150) and Placebo (n=162) were abdominal pain** (21% v.

7%), Nausea (9% v. 6%), Diarrhea (6% v. 4%), Hyperhidrosis (6% v. 1%), Hot Flush (3% v. 2%), Tremor (1% v. <1%), Chills (1% v. 0%). * Adverse reactions occurring in at least 1% of patients receiving RELISTOR injection 12 mg subcutaneously once daily and at an incidence greater than placebo. ** Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort and abdominal tenderness.

During the 4-week double-blind period, in patients with OIC and chronic non-cancer pain that received RELISTOR every other day, there was a higher incidence of adverse reactions, including nausea (12%), diarrhea (12%), vomiting (7%), tremor (3%), feeling of body temperature change (3%), piloerection (3%), and chills (2%) as compared to daily RELISTOR dosing. Use of RELISTOR injection 12 mg subcutaneously every other day is not recommended in patients with OIC and chronic non-cancer pain [see Dosage and Administration (2.2)]. The rates of discontinuation due to adverse reactions during the double-blind period (Study 2) were higher in the RELISTOR once daily (7%) than the placebo group (3%). Abdominal pain was the most common adverse reaction resulting in discontinuation from the double-blind period in the RELISTOR once daily group (2%).

The safety of RELISTOR injection was also evaluated in a 48-week, openlabel, uncontrolled trial in 1034 adult patients with OIC and chronic noncancer pain (Study 3). Patients were allowed to administer RELISTOR injection 12 mg subcutaneously less frequently than the recommended dosage regimen of 12 mg once daily, and took a median of 6 doses per week. A total of 624 patients (60%) completed at least 24 weeks of treatment and 477 (46%) completed the 48-week study. The adverse reactions seen in this study were similar to those observed during the 4-week double-blind period of Study 2. Additionally, in Study 3, investigators reported 4 myocardial infarctions (1 fatal), 1 stroke (fatal), 1 fatal cardiac arrest and 1 sudden death. It is not possible to establish a relationship between these events and RELISTOR. Opioid-Induced Constipation in Adult Patients with Advanced Illness The safety of RELISTOR injection was evaluated in two, double-blind, placebo-controlled trials in adult patients with OIC and advanced illness receiving palliative care: Study 4 included a single-dose, double-blind, placebo-controlled period, whereas Study 5 included a 14-day multiple dose, double-blind, placebo-controlled period [see Clinical Studies (14.2)].

The most common adverse reactions in adult patients with OIC and advanced illness receiving RELISTOR injection are shown in Table 6 below.

Table 6: Adverse Reactions from All Doses in Double-Blind, PlaceboControlled Clinical Studies of RELISTOR Injection in Adult Patients with OIC and Advanced Illness* (Studies 4 and 5). Adverse reactions for RELISTOR Injection (n=165) and Placebo (n=123) were abdominal pain** (29% v. 10%), Flatulence (13% v. 6%), Nausea (12% v. 5%), Dizziness (7% v. 2%), Diarrhea (6% v. 2%). * Adverse reactions occurring in at least 5% of patients receiving all doses of RELISTOR injection (0.075, 0.15, and 0.3 mg/kg) and at an incidence greater than placebo. ** Includes: abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort and abdominal tenderness.

The rates of discontinuation due to adverse reactions during the doubleblind, placebo-controlled clinical trials (Study 4 and Study 5) were comparable between RELISTOR (1%) and placebo (2%).

6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of RELISTOR injection. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Gastrointestinal Perforation, cramping, vomiting.

General Disorders and Administration Site Disorders Diaphoresis, flushing, malaise, pain. Cases of opioid withdrawal have been reported [see Warnings and Precautions (5.3)].

7 DRUG INTERACTIONS 7.1 Other Opioid Antagonists Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

7.2 Drugs Metabolized by Cytochrome P450 Isozymes In healthy subjects, a subcutaneous dose of 0.3 mg/kg of RELISTOR did not significantly affect the metabolism of dextromethorphan, a CYP2D6 substrate.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood-brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Advise pregnant women of the potential risk to a fetus.

8.2 Lactation Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

8.4 Pediatric Use Safety and effectiveness of RELISTOR tablets and injection have not been established in pediatric patients.

8.5 Geriatric Use Of the total number of patients in clinical studies of RELISTOR tablets, a total of 136 patients (10%) were aged 65 years and older, while 23 (2%) were aged 75 and older. In clinical studies of RELISTOR tablets, no overall differences in effectiveness were observed. Adverse reactions were similar; however, there was a higher incidence of diarrhea in elderly patients.

Of the total number of patients in clinical studies of RELISTOR injection, a total of 226 (28%) were aged 65 years and older, while 108 (13%) were aged 75 years and older. In clinical studies of RELISTOR injection, no overall differences in safety or effectiveness were observed between elderly patients and younger patients.

Based on pharmacokinetic data, and safety and efficacy data from controlled clinical trials, no dosage adjustment based on age is recommended.

Monitor elderly patients for adverse reactions.

8.6 Renal Impairment In a study of subjects with varying degrees of renal impairment receiving RELISTOR injection subcutaneously, there was a significant increase in the exposure to methylnaltrexone in subjects with moderate and severe renal impairment (creatinine clearance less than 60 mL/ minute as estimated by Cockcroft-Gault) compared to healthy subjects [see Clinical Pharmacology (12.3)].

Therefore, a dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment [see Dosage and Administration (2.4)]. No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment (creatinine clearance greater than 60 mL/minute as estimated by Cockcroft-Gault).

8.7 Hepatic Impairment Tablets In a study of subjects with varying degrees of hepatic impairment receiving a 450 mg dose of RELISTOR tablets, there was a significant increase in systemic exposure of methylnaltrexone for subjects with moderate (Child-Pugh Class B) and severe (ChildPugh Class C) hepatic impairment compared to healthy subjects with normal hepatic function [see Clinical Pharmacology (12.3)]. Therefore, a dosage reduction of RELISTOR tablets is recommended in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.5)]. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A).

Injection In a study of subjects with mild or moderate hepatic impairment, there was no clinically meaningful change in systemic exposure of methylnaltrexone compared to healthy subjects with normal hepatic function [see Clinical Pharmacology (12.3)]. Therefore, no dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment [see Clinical Pharmacology (12.3)].

Patients with severe hepatic impairment were not studied. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions. If considering dosage adjustment, follow the recommendations in Table 3 [see Dosage and Administration (2.5)].

10 OVERDOSAGE During clinical trials of RELISTOR administered orally and subcutaneously, one accidental case of methylnaltrexone bromide overdose was reported and no adverse events were reported as a result of the overdosage.

A study of healthy subjects noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus. Monitor for signs or symptoms of orthostatic hypotension and initiate treatment as appropriate.

If a patient on opioid therapy receives an overdose of RELISTOR, the patient should be monitored closely for potential evidence of opioid withdrawal symptoms such as chills, rhinorrhea, diaphoresis or reversal of central analgesic effect. Base treatment on the degree of opioid withdrawal symptoms, including changes in blood pressure and heart rate, and on the need for analgesia.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Oral administration of methylnaltrexone bromide at doses up to 200 mg/kg/day (about 81 times the subcutaneous maximum recommended human dose (MRHD) of 12 mg/day based on body surface area) in males and 400 mg/kg/day (about 162 times the subcutaneous MRHD of 12 mg/day) in females and in Sprague Dawley rats at oral doses up to 300 mg/kg/day (about 243 times the subcutaneous MRHD of 12 mg/ day) for 104 weeks did not produce tumors in mice and rats.

Mutagenesis Methylnaltrexone bromide was negative in the Ames test, chromosome aberration tests in Chinese hamster ovary cells and human lymphocytes, in the mouse lymphoma cell forward mutation tests and in the in vivo mouse micronucleus test.

Impairment of Fertility Methylnaltrexone bromide at subcutaneous doses up to 150 mg/kg/day (about 122 times the subcutaneous MRHD of 12 mg/day; about 3.3 times the oral MRHD of 450 mg/day) was found to have no adverse effect on fertility and reproductive performance of male and female rats.

13.2 Animal Toxicology and/or Pharmacology In an in vitro human cardiac potassium ion channel (hERG) assay, methylnaltrexone caused concentration-dependent inhibition of hERG current (1%, 12%, 13% and 40% inhibition at 30, 100, 300 and 1000 micromolar concentrations, respectively).

For more information, go to www.Relistor.com or call 1-800-321-4576.

Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA

Under license from:

Progenics Pharmaceuticals, Inc. Tarrytown, NY 10591 USA

For Injection: U.S. Patent Numbers: 8,247,425; 8,420,663; 8,552,025; 8,822,490; 9,180,125; 9,492,445 and 9,669,096; 10,376,584 For Tablets: U.S. Patent Numbers: 8,420,663; 8,524,276; 8,956,651; 9,180,125; 9,314,461; 9,492,445 and 9,724,343; 10,307,417 and 10,376,505 RELISTOR is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.

Any other product/brand names are trademarks of the respective owners. © 2021 Salix Pharmaceuticals, Inc. or its affiliates Revised: 04/2020 9502505 70014843 REL.0082.USA.19 V4.0

Not only can you take our faculty home with you— now you can also bring them to the gym 365 days a year! www.painweek.org/podcasts

Executive Editor Kevin L. Zacharoff md, facpe, facip, faap Publisher Painweek Art Director Darryl Fossa Editorial Director Debra Weiner Editor Holly Caster

Editorial Board

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 Jennifer Bolen jd Founder Legal Side of Pain Knoxville, tn Martin D. Cheatle PhD Associate Professor Director, Pain and Chemical Dependency Program Perelman School of Medicine University of Pennsylvania Center for Study of Addiction Philadelphia, pa 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 Professor of Psychiatry and Behavioral Sciences George Washington University School of Medicine and Health Sciences Washington, dc Chair Department of Psychiatry and Behavioral Health Services Inova Health System Falls Church, VA

David Cosio PhD, ABPP Psychologist Jesse Brown VA Medical Center University of Illinois at Chicago College of Medicine, Pain Medicine Northwestern Feinberg School of Medicine, Psychiatry and Behavioral Sciences Chicago, il

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

David M. Glick DC, DAAPM, CPE, FASPE CEO & Medical Director HealthQ2 Richmond, va

Steven D. Passik phd Vice President Scientific Affairs, Education, and Policy Collegium Pharmaceuticals, Inc. Canton, ma

Douglas L. Gourlay MD, MSc, FRCPC, DFASAM Educational Consultant Former Director, Wasser Pain Centre Pain and Chemical Dependency Division Toronto, Ontario Gary W. Jay md, faapm Clinical Professor University of North Carolina Department of Neurology Chapel Hill, nc Jay Joshi MD, DABA, DABA-FM, FABA-FM CEO and Medical Director National Pain Centers Vernon Hills, il Theresa Mallick-Searle MS, NP-BC, ANP-BC Nurse Practitioner Stanford Health Care Division of Pain Medicine Stanford, ca

Joseph V. Pergolizzi md Chief Operating Officer nema Research Inc. Naples, fl Michael E. Schatman phd, cpe, daspe Editor-in-Chief Journal of Pain Research Department of Diagnostic Sciences Tufts University School of Dental Medicine Department of Public Health and Community Medicine Tufts University School of Medicine Boston, ma Kathryn A. Schopmeyer PT, DPT, CPE Physical Therapy Program Coordinator Pain Management San Francisco va Healthcare System San Francisco, ca

Mary Lynn McPherson pharmd, ma, mde, bcps Professor and Vice Chair University of Maryland School of Pharmacy Department of Pharmacy Practice and Science Hospice Consultant Pharmacist Baltimore, md

Copyright © 2021, 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.

All rights are reserved by PAINWeek to accept, reject, or modify any advertisement submitted for publication. It is the policy of PAINWeek to not endorse products.

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NEW Clinical Findings From RELIEF Study available for download at dovepress.com

FROM A RECENTLY PUBLISHED OBSERVATIONAL STUDY:

Patients treated with Salonpas Patch reported an almost 50% reduction in pain severity and a substantially better quality of life. ®

1

BPI (Brief Pain Inventory) Severity and Interference Scores Interference

Severity

(Mean % Decrease w/ Salonpas) Overall Pain Severity

(Mean % Decrease w/ Salonpas) Overall Pain Inteference

-49.0%

General Activity

Mood

Ability to Walk

Normal Work

Social Relationships

-60.4%

-60.7%

-61.9%

Sleep

Life Enjoyment

-50.0% -58.1%

-58.8%

-58.3% -69.8%

©2020 Hisamitsu America, Inc. Use as directed.

1 Gudin JA, Dietze DT, Hurwitz PL. Improvement of Pain and Function After Use of a Topical Pain Relieving Patch: Results of the RELIEF Study. J Pain Res. 2020;13:1557-1568

vol.9 2021

PAINWEEK’21 CONFERENCE PREVIEW P.74

18 28 36 42 50 56

medical/legal

rules of the game dea guidelines for controlled substance documentation and treatment actions

by jennifer bolen

by kate schopmeyer

patient communication always be closing

what’s the right sales pitch for active strategies in pain care?

health coaching

what wires together, fires together integrative and complementary strategies for complicated pain

by becky curtis

key topic

comorbid painful hypermobile ehlers danlos & orthostatic postural tachycardia

by nikitha pothireddy anna ruby-trzeciak courtney brennaman anureet walia beth dinoff

op-ed

clash of the titans when opioid prescribing meets those excluded by guidelines

by jessica geiger tanya uritsky

pain basics

pain assessment 7

by kevin zacharoff

63

pw next generation

with laura meyer-junco

64 65 66

clinical pearls

by jennifer hah

one-minute clinician

with david glick, gary jay, james fricton, ginevra liptan, courtney kominek, abigail brooks, michael barnes

68 72

pundit profile

with douglas gourlay

puzzled?

by wendy caster

pain by numbers

12

“Meetings

come to an end, but learning never stops.

PWJ keeps you going all year long.”

—Michael R. Clark md, mph, mba

more than Dinoff provide a detailed article and ever, we are challenged to look at how case presentation of comorbid painful we manage pain from a variety of perhypermobile Ehlers Danlos syndrome Kevin L. Zacharoff spectives. Regulatory scrutiny plays a and postural orthostatic tachycardia. significant role, along with encourageThis piece sheds light on a vulnerable, ment for employing pain management strategies that either com- desperate, and undertreated pain patient population who are ofpletely avoid or at least minimize opioid analgesics when feasible. ten misdiagnosed as having chronic fatigue, fibromyalgia, irritable We must consider the role of education in improving the quality, bowel syndrome, or other condition. I learned a lot from this article safety, and efficacy of the pain care we provide to our patients. and am sure you will. After all, diagnostic competency is all about Maybe the knowledge acquired through education means we con- awareness, isn’t it? sider a less common diagnosis, or maybe it means we hone our skills and abilities to minimize stigmatization, generalization, and even This issue’s Pundit Profile spotlights someone I am lucky enough marginalization. The bottom line is that what we believe, what our to call my friend, my colleague, a fellow anesthesiologist, and a patients believe, and what society ultimately believes has a signif- teacher: Dr. Douglas Gourlay. In all my teaching about pain, I do icant impact in the things we do and how our actions in managing not think there has been a semester that his name does not get pain are perceived. This issue of PWJ has a bit of all these things, mentioned in terms of his writing, teaching, and perspectives. He and more, with the intention of capitalizing pain education as a is both human and superhuman in his ability to convey thoughtpowerful tool to better help us do what we do for patients. ful, relevant, and in virtually all cases “spot-on” commentary that leads to what I consider to be easy learning. Enjoy reading about Not expecting an article in PWJ to be written by an attorney? Think the man and the legend. again. I spend many hours speaking with clinicians about the role various regulatory agencies play in what and how we make clinical Dr. Laura Meyer-Junco is this issue’s Next Generation. Involved decisions, especially prescribing decisions. Jennifer Bolen provides with teaching pharmacy students, providing clinical patient care, a case-based analysis of the Drug Enforcement Agency’s positions and participating in the supportive oncology clinic in Rockford, Ilin cases that should impact how we utilize controlled substances linois, her plate is without a doubt full. Her passions lie in hospice (eg, opioid analgesics), maintain our medical records, and ensure and palliative care, and I will leave it to you to read about her and that, when indicated, our pain management prescribing practices understand her motivation for dedication to those services. are “appropriate.” This article is our own real-world, relevant, “Law Drs. Jessica Geiger and Tanya Uritsky share an Op-Ed on the in& Order” episode. Read it and learn from other clinicians’ pain. tersection of well-intentioned opioid prescribing guidelines and Dr. Kate Schopmeyer’s article scores high on the clinical relevance patient-level impact. Additionally, worthy of mention is the sevscale. We may not consider the “hopes, dreams, and realities” that enth installment of Back to the Basics for people seeking basic our patients with pain bring to clinical interactions. It can be draining foundational pain education. contrasting the reality of decreased resources and frequent feelings of conflict surrounding the needs of the healthcare system and I hope this issue of PWJ sparks interest in attending the PAINWeek those of an individual patient. Dr. Schopmeyer points to exploring National Conference in Las Vegas September 7–11! The need to patients’ beliefs and expectations of treatment as part of the solu- learn, interact, and grow together as a unified team of frontline practitioners has never been greater, and certainly our patients tion, along with tackling patient’s fears head-on. need us now more than ever. I hope to see you there.

Virtually all patients with chronic pain are treated with some type of prescribed pharmacologic component of treatment, and in true Kevin L. Zacharoff MD, FACIP, FACPE, FAAP multimodal fashion we are regularly encouraged to consider complementary and alternative treatments as well. One such strategy is covered by Becky Curtis in her article about the value of pain Kevin L. Zacharoff is Faculty and Clinical Instructor; Course Director, Pain and management coaching as part of a treatment plan. By outlining her Addiction; and Distinguished Visiting Scholar in Medical Humanities, Compassionate own story as a person with chronic pain, Curtis notes the value of Care, and Bioethics in the Department of Family, Population, and Preventive tapping into the parts of our brain that go further than the neuro- Medicine at the Renaissance School of Medicine at Stony Brook University. physiological processes of nociception and perception. Educating patients to reframe their pain experience might not be something we consider as a complementary traditional treatment, but after reading this article it may.

It is not unreasonable to think it would be difficult to diagnose a pain condition we have never heard of. Nikitha Pothireddy, Anna Ruby-Trzeciak, Courtney Brennaman, Anureet Walia, and Dr. Beth

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The national conference on pain for frontline practitioners.

2021 100+ Ce/CMe Credit Hours Presented

September 7–11 Register @ www.painweek.org

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 this live activity for a minimum of 34.0 AMA PRA Category 1 Credit(s)™. This activity will be approved for continuing pharmacy, psychology, nurse practitioner, nursing, and dentistry education. Applications 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.

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Jennifer Bolen JD

Jennifer Bolen is the founder of the Legal Side of Pain in Knoxville, Tennessee. She is an experienced attorney and former federal prosecutor. She is the author of multiple book chapters on documentation of controlled substance prescribing rationale and multiple national lectures on documentation for pain management professionals. She has served the pain community as an expert educator and litigation attorney for nearly 20 years.

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Becky Curtis NBC-HWC, cpmc

Becky Curtis is a pioneer in the application of health and wellness coaching for the problem of persistent pain. Becky founded Take Courage Coaching in 2009 with the goal of helping passive patients become active managers of their own pain by means of her unique coaching process. Becky has served on the Montana Drug Formulary Committee and the Comp Laude advisory board for workers compensation. She is an advocate for persons with chronic pain and is a regular speaker at PAINWeek.

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Nikitha Pothireddy BS

Nikitha Pothireddy is a medical student at Carver College of Medicine, University of Iowa (UI), and her primary research interest involves exploring the relationship between dysautonomia and chronic pain. She coauthored her article with Anna Ruby-Trzeciak, a student at the College of Pharmacy, UI; Courtney Brennaman, MS, a graduate student at the College of Education, Counseling Psychology Program, UI; and Anureet Walia, MBBs, and Beth L. Dinoff, PhD, both of whom are faculty in the departments of anesthesia and psychiatry, Carver College of Medicine, UI.

Kathryn A. Schopmeyer PT, DPT, CPE, CSCS

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Kathryn Schopmeyer is a physical therapist and PT program coordinator for pain management in the San Francisco VA Health Care System. She is an interdisciplinary team member and founder of a CARF-accredited pain rehabilitation program for Veterans, and chairs the SFVAHcs Pain Committee. Dr. Schopmeyer is a clinician, speaker, and educator who is passionate about transforming pain care based on modern science and in the service of individuals who live with persistent pain.

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120 CE/CME CREDITS

EDUCATION IS THE BEST ANALGESIC

By Jennifer Bolen JD

medical/legal

Abstract

The DEA—Drug Enforcement Administration—is a federal agency with both administrative and criminal law enforcement powers.1 DEA Diversion Control Division (DEA Diversion) is responsible for monitoring the flow of controlled substances in the United States under the Controlled Substances Act and the Code of Federal Regulations.2 DEA Diversion has administrative authority to receive, evaluate, deny, and grant certificates of registration to handle (manufacture, wholesale, dispense, prescribe, administer) controlled substances.3 Poor documentation leads to bad outcomes in DEA regulatory cases.

Documentation is critical to showing that the individual practitioner (the “Registrant”):

1 Is aware of and followed controlled substance prescribing standards and issued valid controlled substance prescriptions in accordance with the standard of care associated with the evaluation, treatment, and monitoring of patients on chronic opioid therapy,

2 Treated each patient as an individual, according to his or her specific treatment needs in light of known and potential risks, and

3 Prescribed opioids and other controlled medications for a legitimate medical purpose.

This article quotes recent DEA Decisions and Orders to focus on lessons learned about medical record documentation and the DEA’s perspective through the lens of medical experts and documentation about a Registrant’s duties when controlled medication is part of the treatment plan. A DEA Decision and Order contains the DEA Administrator’s final decisions and instructions regarding the Registrant’s DEA certificate following review of the administrative law judge’s Recommended Rulings, Findings of Fact, Conclusions of Law and Decisions. This article is intended for healthcare practitioners and focuses on comments derived from the cited DEA cases. All citations and comments are made with this target audience in mind.

What is the dea Standard for Revoking or Suspending a dea Registration?

Under Section 304 of the Controlled Substances Act, “[a] registration…to…distribute[ ] or dispense a controlled substance…may be suspended or revoked by the Attorney General upon a finding that the registrant… has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined by such section.”4 In the case of a “practitioner,” which includes a “physician,”5 Congress directed the Attorney General to consider the following factors in making the public interest determination:

1 The recommendation of the appropriate state licensing board or professional disciplinary authority.

2 The applicant’s experience in [prescribing]… controlled substances.

3 The applicant’s conviction record under federal or state laws relating to the . . . distribution, [prescribing,] or dispensing of controlled substances.

4 Compliance with applicable state, federal, or local laws relating to controlled substances.

5 Such other conduct that may threaten the public health and safety.

The Role of the Administrative Law Judge in a dea Administrative Action Against a Registrant An administrative law judge is responsible for conducting formal hearings for the DEA.7 “Administrative law judges may not perform non-adjudicative duties, are precluded from investigative responsibilities, may not receive ex parte communications,8 are not subject to performance evaluations, and may not receive performance awards of any kind.”9 Judges make recommendations based on findings of fact to the DEA Administrator, who issues final DEA Decisions and Orders. DEA’s Administrator is advised by an independent attorney. DEA Decisions and Orders are published in the federal register and may be appealed to the United States Court of Appeals for the District of Columbia or to the United States Court of Appeals in the federal circuit where a registrant maintains a principal place of business.10

What is the Role of Expert Witnesses in dea Administrative Cases?

These factors are considered in the disjunctive, meaning the DEA Administrator, in making the final determination in a DEA Administrative action against a Registrant, “may rely on any one or a combination of factors and may give each factor the weight [the Administrator] deems appropriate in determining whether to revoke a registration.”6

Medical expert testimony often, but not always, forms the basis for contested DEA administrative cases. Medical experts are typically asked to testify about the “standard of care” or “applicable standards” associated with the Registrant’s controlled substance prescribing activities. Both DEA and Practitioner-Registrants likewise look to medical expert testimony in determining whether the Registrant’s prescribing habits pose a danger to public safety. If the Registrant prescribes controlled medications

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to treat chronic pain, medical experts typically testify about testimony by a representative from a private insurer showthe opioid prescribing rules and guidelines published by the ing that Registrant prescribed more controlled medicastate licensing board where the Registrant practices. Med- tions than any of the providers in his same specialty.14 DEA ical experts also testify about the “generally recognized” also presented medical records for six patients, including activities associated with sound medical decision-making “medical” records for an undercover investigator posing as and proper medical record documentation where con- a patient. The undercover visits were recorded and videotrolled substances are involved. Noteworthy is the fact that taped. In total, DEA called five witnesses: a DEA Diversion there are no universal federal opioid prescribing standards Investigator (DI); a detective assigned to the state drug because DEA is not authorized to write such standards.11 task force; an investigator for a private insurer who also acted in an undercover capacity; another law enforcement officer; and a medical expert. All DEA experts were found to be credible in the proceedings.

What are the Most Common Areas of Documentation Weaknesses Described The government’s medical expert witness in dea Administrative Cases? was a physician licensed to practice in Michigan and board certified in addiction medicine. The judge accepted the Generally, common documentation deficien- government witness as an expert in the treatment of cies underlie inappropriate controlled substance prescrib- pain and in the standard of care for controlled substance ing and typically reveal the Registrant’s failure to properly prescribing in the state of Michigan. He testified about evaluate patient risks, failure to individualize patient care, his review of the Registrant’s medical records for the six failure to address and respond to aberrant patient behav- patients at issue, including the undercover “patient,” and iors, and overuse of boilerplate and templated language. presented specific testimony regarding the standard of Two recent cases (discussed below) highlight critical stan- care in Michigan for controlled substance prescribing and dard of care failures and documentation deficiencies in the related documentation.

Pompy also presented evidence through five following areas: witnesses: a medical assistant who worked for him, a laboratory technician who also worked for him, a licensed prac1 Failure to fully evaluate the patient prior tical nurse who worked for him for an extended period of to prescribing controlled medication time (since 1992), his office manager, and a medical expert 2 Failure to take into account the individual who was board certified in anesthesia, pain medicine, and patient’s history and specific risks when prescribing addiction medicine. Pompy’s medical expert witness never controlled medication practiced in Michigan and was not familiar with Michigan’s 3 Failure to address risks presented during the physician-patient relationship, such as pain management and controlled substance prescribing addressing problematic drug test results, prescription policies. The Decision and Order refers to hearing record drug monitoring database information, problematic references where the defense’s expert witness repeatedly medication counts, use of alcohol, use of marijuana, answered questions about the applicable standard of care and the like by referencing what doctors actually do instead of refer4 Failure to coordinate care and refer a encing the actual provisions of the standard of care [in patient to another practitioner to address behavioral Michigan]. Pompy testified and presented evidence about and medical problems his background, his office policies and procedures, how he handled new and established patients, how he addressed 5 Failure to document prescribing rationale for the controlled medications used with the patient, diversion-related issues, his record-keeping practices, the along with dose, quantity, and ongoing use in the face treatment of the patients at issue in the hearing, and other of documented risks12 items.15 Michigan law regarding controlled substance prescribing is similar to federal law and requires that a Case of Lesly Pompy, md ‘‘practitioner…shall not dispense, prescribe, or administer (dea Decision and Order 10/28/2019)13 a controlled substance for other than legitimate and professionally recognized therapeutic or scientific purposes Lesly Pompy, MD, (“Pompy” or “Registrant”) or outside the scope of practice of the practitioner.”16 At practiced interventional pain medicine and was regis- the time of the hearing (July and August 2017), Michigan’s tered with the DEA and authorized to prescribe controlled Guidelines for the Use of Controlled Substances for the substances. Registrant was also authorized to dispense Treatment of Pain (“Michigan Guidelines”) were in effect controlled substances. DEA pursued an action against the and used by the medical experts during the hearing.17 The Pompy’s DEA registration based on allegations that he Michigan Guidelines in effect during the 2017 hearing make issued controlled substance prescriptions without a medi- clear that documentation is critical in any analysis regarding cal need. During the administrative hearing, DEA presented the validity of controlled substance prescribing.

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The Preamble to the Michigan Guidelines, which are largely based on the Federation of State Medical Boards’ July 2013 Model Policy for the Use of Controlled Substances for the Treatment of Pain,17 specifically addresses prescribing and dispensing standards, indicating that the Michigan Boards of Medicine and Nursing will consider prescribing and dispensing to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds…

All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law. [Italicized for emphasis. Internal citations omitted.]18 The stated goal is to control the patient’s pain for its duration while effectively addressing other aspects of the patient’s functioning, including physical, psychological, social, and work-related factors and, thus, the Boards “will judge the validity of prescribing based on the physician’s treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing.”

[Italicized for emphasis. Internal citations omitted].19 Documentation plays a significant role in demonstrating compliance with the 2017 Michigan Guidelines and is still featured today in Michigan’s current opioid laws, which require additional specific documentation at various steps in the physician-patient relationship when opioids are part of the treatment plan.20 The DEA’s Decision and Order in Pompy summarizes the testimony of all witnesses. Readers are encouraged to review the full Pompy decision, which may be found at pain.sh/vp5. See Table 1.

Case of Khan-Jaffrey (dea Decision and Order 7/29/2020)8,21 Kaniz J. Khan-Jaffrey, MD, (“Khan-Jaffrey” or “Registrant”) was a neurologist and registered with the DEA to prescribe controlled substances. At the heart of the investigation were allegations that the Registrant issued controlled substance prescriptions without medical need.

During the administrative hearing, the Government’s documentary evidence consisted primarily of medical records for six patients, including records concerning an undercover investigator. The review covered controlled substance prescriptions issued between 2015 and 2017. The Government called three witnesses: a DEA special agent, who posed undercover as a patient on six occasions; a DEA Diversion investigator, who participated in the investigation; and a medical expert. Each undercover visit was recorded and videotaped. The investigator testified that she first became aware of the Registrant while investigating a pharmacy. The investigator testified that an administrative subpoena was issued to Registrant to obtain complete patient records for 74 named individuals, who were identified based on red flags for diversion, and

another subpoena was issued for updates on 30 of those individuals named in the earlier subpoena.

The government’s medical expert was a physician licensed to practice in New Jersey and a professor of anesthesiology at Rutgers University. He testified about his extensive clinical practice, role of teaching medical students and residents, and serving as the Executive Director of the New Jersey Society of Interventional Pain Physicians. He testified about his review and standard-of-care analysis of medical records belonging to six of Registrant’s patients, including the undercover “patient.” The government’s medical expert also reviewed the undercover tapes and audio recordings. He testified about his review of the Registrant’s medical records for the six patients at issue, including the undercover “patient,” and presented specific testimony regarding the standard of care in New Jersey for controlled substance prescribing and related documentation.

Khan-Jaffrey also presented evidence through four witnesses: the expert witness for the defense was a physician who treated pain for 30 years and then served as an associate professor of anesthesiology and neurology at the Icahn School of Medicine, Mt. Sinai Hospital, New York, and has held professorial appointments and staff positions at multiple hospitals in New York. At the time of the hearing, he was the Chair of the New York State Board of Medicine and involved in writing New York’s law concerning its prescription monitoring program. He testified that he was familiar with the standard of care for prescribing pain medicine and has published articles and spoken publicly about prescribing opioids, including the “overprescribing” of opioids during the relevant period. He held a license but never practiced in New Jersey and his NJ license was inactive at the time of the hearing. The expert witness did in fact review the New Jersey materials governing pain management but claimed the standard of care does not include New Jersey statutes and that it differs by region and the number of patients a doctor sees on a daily basis. He testified that there is a nationwide standard of care, which he applied in his evaluation of the case materials.

Khan-Jaffrey also testified about her residency in neurology and fellowship in pain management.

Prior to opening her own practice, Khan-Jaffrey testified that she worked for two years at a neurosurgeon’s office and then at her husband’s practice; Registrant also consulted in pain management at a local regional medical center.

She further testified as to her standard pain management practice with respect to the patients in question, including her use of monthly urine screens, her practice of obtaining MRIs before prescribing controlled substances, her use of an electronic recordkeeping system, and her requirement of a referral into her practice. Khan-Jaffrey also testified specifically about her treatment of the six patients at issue in the hearing. She stated that she saw 50 to 55 patients per day and billed about ten minutes per patient. She testified about her requirement that each patient have a referral from a physician to make an appointment and how she

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Table 1. Key issues raised in Pompy Issue

Government

Defense and DEA Administrator’s Comments (if applicable)

Standard of care

Referenced the Michigan’s licensing board materials The defense expert medical witness essentially opined that Dr. and rules/guidelines; discussed in depth in the Pompy’s prescribing should be evaluated on what doctor’s actually Decision and Order do instead of using the standards set forth in the Michigan rules/ guidelines. The DEA Administrator rejected the opinion of the defense expert witness.

Ordering a prescription drug monitoring report

Michigan controlled substance prescribers are required to check the Michigan Database.

Registrant failed to follow-up with patient or other providers on abnormalities in prescription database reports through Michigan Automated Prescription System (MAPS)

Ordering a prescription drug monitoring database report is not a standard of care because 50% of physicians order them out of fear.

The DEA Administrator rejected this opinion.

Co-prescribing of opioids and benzodiazepines

Co-prescribing opioids and benzodiazepines is a departure from the standard of care.

Co-prescribing of opioids and benzodiazepines is common, but it’s unsafe. The DEA Administrator rejected this opinion.

Counseling a patient whose drug screen tests negative for a prescribed controlled substance

Michigan standards require the physician to address a negative drug screen with the patient.

After receiving the results of abnormal urine drug tests, Respondent failed to document any discussion of the test results with the patient, as Michigan and the standard of care requires.

Despite abnormal urine drug tests, Respondent re-issued controlled substance prescriptions without sufficiently documenting that he had appropriately addressed the abnormalities.

While this is what is done most often and is good medicine, it’s not the standard of care. The DEA administrator rejected this opinion.

Actively monitoring for aberrant behavior and risks

Michigan standards require the physician to actively monitor and respond to patient risks.

Despite the appearance in a patient’s urine drug test of controlled substances that Respondent had not prescribed, or illegal substances, Respondent continued to issue controlled substance prescriptions and did not put adequate documentation of his decision-making in the medical records.

Always looking at aberrant behavior is different from checking for it.

If you know the patient has done something, you need to intervene.

The DEA Administrator rejected the defense expert’s suggestion that Registrant’s do not have a duty to take steps to prevent abuse and diversion each time a controlled substance prescription is considered/ issued. Steps should be taken to mitigate abuse and diversion even if the physician doesn’t “know” if the patient is engaging in these behaviors.

Michigan Standard for a controlled substance prescription (general)

A Registrant must prescribe for a legitimate medical purpose and in the usual course of professional practice; a Registrant must be diligent in the prevention of diversion.

More generalized

Michigan standard for treatment goals and managing risks (documentation)

The goal of a physician treating a patient in pain is to manage the pain while effectively addressing the patient’s functioning and mitigating the risk of misuse, abuse, diversion, and overdose.

The validity of the physician’s treatment is judged on the basis of available documentation, not solely on the quantity and duration of medication administered.

More generalized and discussed in terms of best practices vs minimum standards

required each of her patients to take monthly urine drug into great detail about the New Jersey pain management screens, which she does at her own volition and expense, regulations and how they frame the standard of care in despite the burden it imposes. Both the judge and the DEA a DEA administrative case. The case revolved around two Administrator found credibility issues with the contested core issues: (1) whether Dr. Khan-Jaffrey’s medical record portions of Khan-Jaffrey’s testimony. In fact, in making his documentation and presented testimony demonstrated decision to reject the judge’s recommendation of action her compliance with the New Jersey regulations and thus short of suspension, the DEA Administrator made a point of the standard of care for controlled substance prescribing, commenting on Khan-Jaffrey’s lack of credibility and lack of and (2) whether she had a plan for embracing her duties as acceptance of her duties and responsibilities as a DEA Regis- a physician and for improving her documentation and procetrant and instead suspended her DEA registration. dures such that she could be trusted, and patients could be Khan-Jaffrey also offered the testimony of guaranteed some level of safety under her care. another expert witness for the defense on requirements The DEA’s Decision and Order summarizes the associated with medical record documentation. At the time, testimony of each of these witnesses. Readers are encourthis witness was a practicing psychiatrist and professor aged to review the full Khan-Jaffrey decision, which may be of psychiatry at Harvard Medical School and lectured on found at pain.sh/qtd. See Table 2. electronic medical recordkeeping, among other medical subjects. He testified that as a hospital records committee chairperson reviewing medical records for quality assurance Conclusion for many years, he developed his study of medical recordkeeping, and has published several peer reviewed articles The standard of care in DEA administrative on medical documentation, and lectures on the subject cases is informed primarily by medical board regulations worldwide. He testified that he is not licensed to practice and guidelines for the state in which Registrant practices. medicine in New Jersey, but he follows the developments Prescriber documentation demonstrating adherence to of medical documentation in New Jersey, and he reviewed standard of care directives is critical and medical experts some of the New Jersey regulations and laws about medical primarily use medical record documentation to evaluate recordkeeping in preparation for the hearing. He also testi- prescribing decisions. A Registrant’s use of boilerplate fied that he was not familiar with Khan-Jaffrey’s electronic entries without individualized patient facts presents sigrecordkeeping system. nificant challenges in DEA administrative cases and makes Finally, Khan-Jaffrey offered the testimony of it difficult for medical experts to evaluate whether conone of the six patients whose records were at issue in this trolled substance prescribing was handled in compliance proceeding. The patient was established with the Regis- with the applicable standard of care and thus whether the trant and was treated by her for neuropathy in his feet and Registrant prescribed controlled substances for a legitipain due to a pinched nerve and degenerative disc disease mate medical purpose while acting in the usual course of in his lower back. He testified generally about the care he professional practice. DEA Registrants should take time to received from Khan-Jaffrey and how she handled counsel- read the Pompy and Khan-Jaffrey Decisions and Orders and ing when he presented with inconsistent urine screens. The use these cases to guide documentation improvements. judge found discrepancies in the patient’s testimony and These cases provide significant insight to the use of medical cited that these detracted from the patient’s credibility. experts in DEA administrative cases and to the “what” and The Decision and Order contains the specifics about the “how” of medical record documentation on critical markers of the physician-patient relationship when controlled subdiscrepancies and their merit to the case.

The Khan-Jaffrey Decision and Order goes stances are part of the care plan.

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Table 2. Key issues raised in Khan-Jaffrey Issue

Government

Defense and DEA Administrator Comments (if applicable)

Standard of care

New Jersey Regulations (Note: the government’s expert witness mistakenly referred to NJ statutes here, but the record was corrected to reflect the regulations).

The defense expert witness testified about a national standard of care rather than the specific standards established by the NJ Regulations. The DEA Administrator found that the New Jersey laws and regulations, and the direct testimony of a New Jersey practitioner (the government expert witness), directly contradicted the defense’s medical expert and depiction of the applicable standard of care.

Physical examination Required by the standard of care; Registrant failed There was much deliberation over what constitutes an adequate before prescribing to conduct a physical examination of the underphysical examination; read the opinion. controlled medication cover officer and controlled substance prescriptions issued by Registrant to the undercover “patient” were without legitimate medical purpose and outside the usual course of professional practice (in violation of the standard of care); mere observation without directed movement is insufficient.

Discussing breaches of the pain management agreement and documenting the discussion and treatment plan with justification for ongoing opioid therapy (general)

Required by the standard of care; Registrant failed to have and document discussions with her patients following various aberrant drug-related behaviors and make a treatment decision. If the decision is to continue opioid therapy, the prescriber must document justification for doing the same. Several forms of aberrant behavior were examined during the hearing, including: a patient with multiple drug tests positive for alcohol metabolites; a patient with unsanctioned controlled medication present in the urine; and a patient with a urine test showing negative for prescribed opioids.

The defense expert witness testified that documentation of the discussion (or counseling session) with the patient is a “best practice” rather than the standard of care in NJ. The DEA Administrator rejected this position, pointing to the government’s expert witness testimony as a NJ-licensed and practicing physician and to the NJ regulations.

Counseling a patient whose drug screen tests negative for a prescribed controlled substance

See the entry in the row above and read the Khan-Jaffrey opinion.

See above and read the opinion.

Dismissal of patients following a problematic drug test result

No universal standard here other than the requirement of counseling and documentation, and a treatment plan that demonstrates efforts to guard against the problems in the future.

No universal standard here. Testimony similar to the government expert witness.

Drug test results Registrant must address breeches of treatment positive for an agreement and document these efforts in the illicit or unsanctioned medical record. substance

The defense expert witness testified that he would give the patient more latitude and would speak to the patient. He did not testify that the standard of care required the Registrant to document the conversation and ensuing treatment decision and control measures.

The DEA Administrator therefore rejected the defense expert witness’ position and applied the standard of care as stated in the New Jersey Regulations and by the government’s expert witness.

Documentation of alcohol counseling

Registrant often failed to document her discussion with the patients, as required by the NJ Regulation and as reflected by the charts examined. During the hearing, Registrant tended to blame her electronic medical record system. The DEA Administrator found this to be problematic and, in part, reflective of the Registrant’s failure to accept her responsibilities as a DEA Registrant and medical doctor.

See the opinion for more discussion on “alcohol” use with opioids and what the standard of care requires in response. The DEA Administrator’s reasoning for rejecting the judge’s recommendation and decision to suspend Khan-Jaffrey’s registration is insightful and should be reviewed.

The standard of care requires the Registrant to discuss the urine drug test revealing alcohol use and to counsel the patient to stop drinking; document the discussion and plan in the record.

References/Resources/Comments 1.

13. Pompy Decision and Order. Available at: www.federalregister.gov/ documents/2019/10/28/2019–23503/lesly-pompy-md-decision-and-order.

DEA Mission Statement. Available at: www.dea.gov/mission.

14. The private payor data covered Registrant’s prescribing activities between 2012–2015.

2. DEA Diversion Control Unit-Mission Statement. Available at: www.deadiversion.usdoj.gov/Inside.html.

15. This case also involved TIRF REMS, which all the more reinforces the documentation points made in the case decision.

3. U.S. Department of Justice Drug Enforcement Administration. Diversion Control Division. Registration. Available at: www.deadiversion.usdoj.gov/faq/registration_faq.htm.

4.

21 U.S.C. 824(a)(4).

5.

21 U.S.C. 802(21). 21 U.S.C. 823(f).

6.

See DEA Decision and Order in Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).

7.

5 U.S.C. § 551, et seq.

16. Mich. Comp. Laws § 333.7401(1) (Westlaw, current through P.A. 2019, No. 18 of the 2019 Regular Session, 100th Legislature).

17. FSMB, Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain, July 2013. This policy was replaced in April 2017, with the FSMB’s updated Model Policy, available at: www.fsmb.org/opioids/.

18. The DEA administrative hearing for Dr. Pompy took place in 2017, when Michigan used a different set of Prescribing Guidelines than is currently used in the state.

Currently, information from Michigan’s Licensing and Regulation Agency (LARA) (Medicine) points to the CDC Guidelines, accessed online on 3–26–21 at www.michigan. gov/opioids/0,9238,7–377–88141_88294---,00.html. The older version of the Michigan Guidelines closely followed the Federation of State Medical Boards Model Guidelines on the same topic. Michigan changed its opioid prescribing platform beginning June 1, 2018 (based on a new law passed in Dec. 2017). See mi.gov/documents/lara/Curriculum_MODEL_CORE_FINAL_APRIL_2013_MAILING_424376_7.pdf. See also Michigan FAQ on new opioid prescribing laws, available at mcrh.msu.edu/resources/LARA_DHHS_Opioid_ Laws_FAQ_REVISED_06–01–2018.pdf (containing FAQ updates through 6/1/2020).

This paper is using the old Michigan Guidelines because that is what was used in the Pompy Decision and Order.

8. In the context of a DEA administrative case, an ex parte communication is a discussion between the judge and only one party (or agent/representative) to the legal proceeding outside the presence of the opposing party. Unless an ex parte communication fits into a defined exception, these communications are unethical at best and may subject the participants, including the judge, to sanction, reprimand, disbarment, and more.

9.

DEA. Available at: www.dea.gov/divisions/administrative-law-judges.

10. 21 U.S.C. § 877.

11. DEA Dispensing Controlled Substances for the Treatment of Pain, Policy Statement. Unofficial version. Available at: www.deadiversion.usdoj.gov/fed_regs/ notices/2006/fr09062.htm. Also identified as FR Doc. E6–14517 Filed 9–5-06. Also available through the Government Printing Office: www.gpo.gov/fdsys/pkg/FR-2006– 09–06/pdf/FR-2006–09–06.pdf. This document represents one of DEA’s greatest efforts to provide insight to Registrants regarding DEA’s expectations when controlled substances are part of pain care. An in-depth discussion of the DEA’s Policy Statement is beyond the scope of this article but is discussed by this author in the PAINWeek and PAINWeekEnd programs “Drugs, Documentation, and DEA.”

19. Pompy Decision and Order. Available at: pain.sh/vp5.

20. See Michigan FAQ on new opioid laws and additional documentation. Available at: mcrh.msu.edu/resources/LARA_DHHS_Opioid_Laws_FAQ_REVISED_06–01–2018.pdf.

Referencing updates through 6/1/2020.

21. Khan-Jaffrey Decision and Order. Available at: pain.sh/qtd.

12. See Pompy and Khan-Jaffrey Decisions and Orders cited in Notes 13 and 20 below.

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By kate schopmeyer JD

in the United States has come a long way in the last 30 years. It takes diligent introspection and dedication to evidence-based medicine for healthcare providers to update their practice in response to updates in science. As pain care evolves and practices change, we can celebrate the transformation of the system along with our own professional growth. Retrospection and wisdom allow providers who have lived and worked through major transitions in healthcare trends to appreciate the growing pains (no pun intended) and keep focus on future directions. In the pain management sector, this diligence can be exhausting largely because the problem of persistent pain is still broadly misunderstood. For healthcare providers who regularly attend up-to-date conferences like PAINWeek, being “in the know” can make it seem that we’re on the precipice of improving suffering and disability related to persistent pain. So why, then, does it still so often feel like we’re pushing a boulder uphill? This article explores factors that contribute to provider burnout, patient disengagement, and the patient-provider relationship, and offers practical tactics to employ during clinical encounters.

patient communication

HOPES, DREAMS,

AND REALITIES

Trained medical and allied health professionals who care for people in pain generally hope to decrease suffering for their patients. Motivation to perform daily professional duties stems from an innate interest in helping others, a will to serve individuals and contribute to society, and pursuit of job satisfaction. The patients who thank you for helping them find a way back to work, regain their ability to play with grandchildren, return to sport, or finally get dressed without assistance are the reward for the years of study and academic training or the long hours in the surgical bay, medical clinic, or emergency department.

A digital health transformation now allows some clinicians and patients access to impressive technology-assisted interventions such as augmented reality headsets to treat psychological phobias, posttraumatic stress, and movement impairments; virtual reality immersion into a fantastical world to distract from pain during severe wound debridement; robotic surgery devices; 3D-printed pharmaceuticals and digital tattoos for health data collection and transmission. For some, the horizon for medical care seems bright and endless. Modern healthcare systems are rife with opportunity for healthcare professionals to apply their knowledge, skills, and expertise.

But the reality for many may be less sunny.

The unfortunate (nonaugmented) reality is that the benefits of capitalist-based healthcare systems come at a cost. Ever-shrinking clinic visit time slots, productivity reports and performance metrics, profit margins, and quarterly QI demands are arguably disliked by the people providing—and receiving—direct patient care. Patients

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grappling with one or more chronic health condition require extra time and attention, especially from primary care providers. If your patient’s primary complaint is pain that persists, yet you also know that his A1C is elevated, he has uncontrolled hypertension, and he still has not started wearing the C-PAP machine you prescribed 3 months ago for his obstructive sleep apnea, your goals for the session may be at odds with those of your patient. When healthcare providers struggle to reconcile the needs of a system and an individual patient, burnout risk increases, and patients suffer. How can we decrease the burden of being a patient and enhance the joy of being a medical or allied health professional? Bring it back to the basics—communication.

Humans are complex but treatment plans do not have to be complicated or include sophisticated technology to be effective for chronic musculoskeletal pain. Try distilling your discussions down to this: exploring patients’ beliefs and expectations for their care.

BELIEFS: The Silent Saboteur

How often do you reflect on your beliefs about pain or ask your patients about their pain-related beliefs or expectations for the treatments you recommend?

The paradox between healthcare professional recommendations and patient engagement may be iatrogenic. Several authors have explored the power of beliefs in healthcare and the influence patient beliefs have on their engagement and health outcomes.1-3 Beliefs affect the experience of pain and directly influence patient engagement in care.

Researchers have also demonstrated the influence healthcare professionals have on the beliefs of our patients, especially with regard to back pain.4-7

Figure. Common Sense Model Framework8

A 2021 qualitative study exploring beliefs about chronic musculoskeletal pain clearly illustrates the predominance of biomechanistic narratives in society.1 The relationships between causality (“Why do I hurt?”), identity/curability (“What can I do for the pain? What can healthcare providers do for my pain?”), and a timeline (“How long will it take for me to get better?”) present a framework that easily traps patients in a passive approach to coping with chronic musculoskeletal pain (see Table).

Based on the Common Sense Model for illness cognition, a patient’s understanding of a disease or illness and the expected outcomes for treatment options dictate adherence or nonadherence to treatment regimens (see Figure).8 If a person believes that the cause of their pain is progressive, and irreparable harm was done to their internal joint structures, it is logical that s/he would fear painful movement lest it worsen the mechanical damage. This person would also logically rely heavily on doctors to “fix” the structures before attempting to get back to their normal life. If a person believes his painful spine has fragile discs that easily dislocate or slip out from between their vertebrae with certain painful movements, how can we blame him for doubting the benefit or safety of movement? Within this limited biomechanical framework, doctors are solely responsible for the repair of joint damage or to provide other therapies for the person living with painful knees or backs. It is common sense.

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Table. Patient Identified Beliefs1 Causality beliefs: ● “Pain is a sign of damage.” ● “You have a slipped disc.” ● “There is degeneration in your spine.” ● “Your knee osteoarthritis is bone on bone.” ● “I see fissures and tears in the hip tendons.”

Identity/curability statements: ● “Physiotherapy can’t help bone on bone.” ● “We may have to replace the damaged structure” ● “We can’t fix the damaged structure.” ● “There is no cure for back pain.” ● “This mechanical problem requires a mechanical fix.” ● “The labral tear needs to be knitted back together.”

Timeline conceptualizations: ● “Back pain gets worse with ageing.” ● “Osteoarthritis has a downward trajectory.” ● “Unless the damages can be fixed, your pain is here to stay.”

How often do you reflect on your beliefs about pain or ask your patients about their pain-related beliefs or expectations for the treatments you recommend?

MODERN PAIN TARGET CONCEPTS

Humans naturally struggle to make sense of pain that persists, and healthcare professionals unfortunately are not consistently trained in teaching people about persistent pain. Until academic medical and allied health training programs update all curricula to be consistent with modern pain science and practice in a manner consistent with clinical practice guidelines for biopsychosocial pain care, licensed providers are independently responsible for educating themselves and adapting their behaviors after synthesizing old information with new.

Resources are available to assist clinicians with advanced degrees to update their knowledge base about pain, pain mechanisms, and explaining pain.9-12 When diagnosing and treating any pain condition, practitioners should learn target concepts, then incorporate and fully explain them to patients13:

● Pain is complex and individual. ● Pain is protective, not a measurement of body damage. ● Pain experiences are constructed from multiple body systems and brain networks: affective, cognitive, and sensory. ● Pain is modulated by physical factors, emotional factors, psychological factors, and social factors.

Beliefs are an important target for the management of musculoskeletal pain; it is our duty as healthcare providers to elicit and correct unhelpful patient beliefs about pain.14,15

“HOW

CAN I EXPLORE PAIN BELIEFS WITH MY PATIENTS?”

Clinicians should regularly examine their own beliefs about pain and explore patient beliefs as early

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as possible. Beliefs are changeable, but only if revealed.

The most important patient beliefs16 for a practitioner to assess and address are:

1 The meaning of pain 2 Fears of hurting (pain consequence) 3 Fears of harming and further injury

vulnerability 4 Self-efficacy related to pain

Below are sample questions to use in a clinical interaction17: ● Damage beliefs: Q “What do you think causes your pain to continue for this long?”

Q “What have doctors told you about your pain?” ● Meaning of pain: Q “What concerns you most about your pain?” ● Impact on daily activities: Q “What have you stopped doing because of pain?” ● Health condition understanding: Q “Have you been given a diagnosis for your pain?”

Q “Can you tell me what that means in your own words?” ● Fear of injury: Q “Do you worry that pain with or after activity means you have reinjured yourself?” ● Self-efficacy: Q “What strategies do you have to engage in meaningful activities despite your pain?” ● Expectations: Q “What do you think you need (for treatment) to achieve your goals?”

KEY CONCEPTS AND CLINICAL PEARLS

INSIGHTS FROM PEOPLE WHO LIVE WELL WITH CHRONIC PAIN

Qualitative research conducted on people living well with chronic pain conditions without the help of healthcare professionals shows a process of making sense, deciding to move on with life, and flexibly persisting.18 According to Dr. Lennox Thompson, the lead author of the article entitled “Living Well with Chronic Pain: A Grounded Theory,” individuals continue to seek a diagnosis until they receive one matching their representation.16 Participants in this qualitative research said their pain was a puzzle or a mystery until a diagnosis had been made. Chronic primary pain is now a distinct diagnostic code in the International Classification of Diseases codex. “Chronic primary pain” can be chosen when pain has persisted for more than 3 months, is associated with significant emotional distress and/or functional disability, and when the pain is not better accounted for by another condition.19 Naming the pain condition may be a key factor to help patients make sense of persistent pain and, if used, should be accompanied by a message about hurt and harm not being equivalent. In addition, patients should understand the need for a lifelong approach to managing any chronic pain problem.

CONFOUNDING FACTORS

Chronic health conditions, specifically high-impact chronic pain, impose many burdens on people beyond the daily suffering of bodily discomfort, emotional distress, and social impairments. Even at the best of times, negotiating healthcare systems can feel as daunting as attempting to eat a full-grown African elephant. In a multicountry qualitative study of patients with chronic conditions, researchers learned that chronic health conditions are burdensome for those who seek healthcare services to manage those conditions.20 For the more than 3,000 respondents, the burden of being a patient stretched far

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beyond the daily mental, physical, and emotional toils imposed by the disease conditions alone. When offering medical advice or recommendations, healthcare providers may not understand the difficulties of the tasks imposed on patients, such as medication management, lifestyle changes, and follow-up visit planning. Each task comes with a myriad of consequences, including nonadherence (intentional and unintentional) and the deep emotional impact from frustration, guilt, and associated sick-role identity from continuous healthcare seeking behavior.

CONCLUSION

If you care for people with a primary complaint of chronic musculoskeletal pain concomitant with other chronic health conditions, consider the burden of being a patient as you select treatment plan recommendations and negotiate each component with the individual in front of you. How would you instruct someone to eat an elephant? One bite at a time.

References 1. Caneiro JP, Bunzli S, O’Sullivan P. Beliefs about the body and pain: the critical role in musculoskeletal pain management. Brazilian J Phys Ther. 2021;25(1):17–29.

2. Caneiro JP, O’Sullivan P, Smith A, et al. Implicit evaluations and physiological threat responses in people with persistent low back pain and fear of bending.

Scand J Pain. 2017;17:355–366.

3. Caneiro JP, O’Sullivan P, Lipp OV, et al. Evaluation of implicit associations between back posture and safety of bending and lifting in people without pain.

Scand J Pain. 2018;18(4):719–728.

4. Darlow B, Dowell A, Baxter GD, et al. The enduring impact of what clinicians say to people with low back pain. Ann Fam Med. 2013;11(6):527–534.

5. Darlow B, Fullen BM, Dean S, et al. The association between healthcare professional attitudes and beliefs and the attitudes and beliefs, clinical management, and outcomes of patients with low back pain: a systematic review. Eur J Pain.

2012;16(1):3–17.

6. Caneiro JP, O’Sullivan P, Smith A, et al. Physiotherapists implicitly evaluate bending and lifting with a round back as dangerous. Musculoskelet Sci Pract. 2019;39:107–114.

7. Darlow B, Perry M, Dean S, et al. Putting physical activity while experiencing low back pain in context: balancing the risks and benefits. Arch Phys Med Rehabil.

2016;97(2):245–251.

15. Caneiro JP, O’Sullivan PB, Roos EM, et al. Three steps to changing the narrative about knee osteoarthritis care: a call to action. Br J Sports Med. 2020;54(5):256–258.

16. Main CJ, Foster NBR. How important are back pain beliefs and expectations for satisfactory recovery from back pain? Best Pr Res Clin Rheumatol. 2010;(24):205–217.

8. Leventhal H, Diefenbach M, Leventhal EA. Illness cognition: using common sense to understand treatment adherence and affect cognition interactions. Cognit Ther Res. 1992;16:143–163.

9.

17. O’Sullivan PB, Caneiro JP, O’Keeffe M, et al. Cognitive functional therapy: an integrated behavioral approach for the targeted management of disabling low back pain. Phys Ther. 2018;98(5):408–423.

Butler DS, Moseley GL. Explain Pain. Adelaide, Australia: Noigroup Publications.

10. Lewis J, O’Sullivan P. Is it time to reframe how we care for people with nontraumatic musculoskeletal pain? Br J Sports Med. 2018;52(24):1543–1544.

18. Lennox Thompson B, Gage J, Kirk R. Living well with chronic pain: a classical grounded theory. Disabil Rehabil. 2020;42(8):1141–1152.

11. Moseley LG, Butler DS. Explain Pain Supercharged. 1st ed. Adelaide, Australia: Noigroup Publications; 2017.

19. Nicholas M, Vlaeyen JW, Rief W, et al. The IASP classification of chronic pain for ICD-11: chronic primary pain. Pain. 2019;160(1):28–37.

12. Moseley GL, Butler DS, David S. Explain Pain Handbook: Protectometer.

Noigroup Publications; 2015.

20. Tran VT, Barnes C, Montori VM, et al. Taxonomy of the burden of treatment: A multi-country web-based qualitative study of patients with chronic conditions.

BMC Med. 2015;13:115.

13. Moseley GL, Butler DS. Fifteen years of explaining pain: the past, present, and future. J Pain. 2015;16(9):807–813.

14. Caneiro JP, Roos EM, Barton CJ, et al. It is time to move beyond a ‘body region silos’ to manage musculoskeletal pain: Five actions to change clinical practice.

Br J Sports Med. 2020;54(8):438–439.

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Remember your ABCs.

By Becky Curtis NBC-HWC, CPMC

health coaching

Pain is much more complicated than we often think, and recovery has too long been a pharmaceutical or procedure-led process. As a C4 incomplete chronic pain survivor, I have learned from the neck down that managing chronic pain requires the power of the brain. This is why I created a pain management coaching program: coaches can walk alongside clients on their way to recovery, giving them needed courage, tools, and strategies to manage their pain.¶We used to think about pain as a signal of tissue damage that people had no more control over than the trigger itself. The more we study chronic pain, however, the more we find that the brain can experience a pain signal for perfectly healthy tissue.1 That fact might make many people feel hopeless in the face of chronic pain, but brain pathways are not just currents tirelessly eroding a rock.

They are more akin to Zen gardens that can be trained, molded, and recreated. What we focus on we empower and enlarge. We have the power to change our brain’s responses to pain. In more scientific language, “Evidence suggests that ‘focused attention’ can increase neuronal plasticity and hence be used to positively reprogram brain pathways.”2 Our brains are capable of radical and almost miraculous change because of neuroplasticity.

When we speak of “neuroplasticity” we mean the

brain has the ability to change. Colloquially we might say, “What fires together, wires together.” Neuronal connections multiply, and signals intensify with use, and this plays an important role in the development of chronic pain. It is a learned experience in the sense that those who focus on their pain empower and enlarge the experience until pain becomes the dominant reality in their lives. While it is helpful to know why chronic pain develops in the brain, how does this knowledge help those suffering daily from intense chronic pain? How can they change this progression? The answer lies in an even more familiar adage, “What you don’t use, you lose.” Just as we learn chronic pain through constant focus, we can unlearn pain by refocusing and reframing our experience. Perhaps my experience with neuroplasticity will be helpful. I learned how to reprogram my brain’s pathways after a violent rollover car accident caused my incomplete c4 spinal cord injury.

Opioids did nothing to stop the burning central nerve pain, they just took my brain out of the game. Surgery was out of the question due to a syrinx in the middle of my spinal cord.

I felt like I was out of options until my physician referred me to a functional restoration program.

At the functional restoration program, I discovered that a few deep breaths from the diaphragm could take my pain from an 8 to a 4. It took practice and then regular use on a daily basis, but it helped me manage my pain, and I saw results in how I felt within just a few days of utilizing this new tool. With the support of the program’s physical therapist, I started to exercise and stretch, and learned how my thoughts affected my pain and how pacing myself kept things manageable. Negative thoughts

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such as “I can’t stand this pain one more minute” caused flares to increase. If I redirected my thoughts instead to something like “This isn’t killing me. This is chronic pain not acute pain. Nothing is wrong with my body, this is normal,” my experience of pain decreased and my suffering subsided. These and many other tools, such as a better sleep routine and an anti-inflammatory diet, helped to keep my pain under control. I started to realize pain is not out of our control, but something we can actively mold and change. Then I decided I needed to help others do this as well.

Dr. Deepak Ravindran, while a guest on a podcast called “Chronic Pain, Neuroplasticity, and Trauma-Informed Pain Care,” clarified our problem with chronic pain.3 He suggested that while we have the much needed DFY (do it for you) medical model and the DIY (do it yourself) model, we are missing the DWY (do it with you) model. This is why I developed pain management coaching: to fill in the missing link in the pain chain. Somewhere between medical treatment or surgery and personal self-care, a chronic pain sufferer needs a coach to provide essential support and education so the patient can self-manage pain instead of being a passive patient. Ideally anyone who sustains an injury likely to develop into complicated pain should be referred to a pain management coach early in their recovery process because redirecting focus and reframing the pain experience could help prevent pain from becoming chronic in the first place.

A telephonic coaching session has been lik- between client and coach, focusing on strengths and ened to a dance where the coach offers gentle guidance solutions rather than weaknesses and barriers. We build while strongly supporting the client’s autonomy. We target on trust and rapport to support the client. The chronic behavior changes the client would like to make and assist pain sufferer is in control, with ample time spent to help them with harnessing motivation and support systems to facilitate positive change. The client learns and makes be successful in walking through the change process. We positive lifestyle changes at his/her own pace. Mel Pohl, start a session positively by having the client share some- MD, encourages such approaches when he writes, “We thing that has been going well. We then move into a goal must harness the science of pain and educate patients exploration from the previous week, moving next to where to reframe their experience through coaching and other the client would like to focus going forward. Time is spent modalities that empower them to take an active role in exploring and eliciting the client’s reasons for change and owning both the problem and the solution.”4 Pain manhow best to facilitate that change. Attention is paid to the agement coaching exists to address such a need, and the SMART goal model: small, measurable, attainable, realis- stories of our clients speak for themselves. tic and time-based. The coach is always listening for ways to affirm and call out strengths the client is displaying and linking strengths to the client’s goals and vision.

The challenge is that the only way to treat a Tiffany was ejected from a car at 67 miles an chronic pain sufferer at this level is from the inside out: THEY must be the expert because only they can truly get “in hour, fracturing her t12, l1, and l2 vertebrae. In addition there” to fix anything. After all, it’s the patient’s experience, to partial paralysis, she developed severe central nerve the patient’s brain, and the patient who is best equipped. pain below her level of injury. When she came to Take For many years almost anyone could “prac- Courage Coaching, she felt hopeless after trying conventice coaching” without any technical qualifications, cer- tional pain management treatments, opioids, medical tification, or education. However, starting in 2016, the marijuana, CBD, herbs, supplements, acupuncture, cryoNational Board for Health & Wellness Coaching (NBHWC) therapy, and every cream she could find. As she has said, collaborated with the National Board of Medical Exam- “Working with a TCC coach was like getting a battle partiners to provide a robust board certification examination ner,” someone she could bring her “successes and failures that has led to more than 4,000 National Board-Certified to without being judged.”

Her coach allowed Tiffany to spend as much Health & Wellness Coaches who hold the NBC-HWC credential. According to nbhwc.org, those who wish to sit time as she needed during the first coaching session tellfor this examination must “Complete an NBHWC approved ing her story and the impact on her life. From that point training program, complete 50 health & wellness coaching on the focus in the coaching relationship moved toward sessions, and have an associate’s degree or higher, or com- partnering with Tiffany as she sampled different pain plete 4,000 hours work experience (any field).” Once they management tools such as diaphragmatic breathing, have passed the certification examination they can prac- relaxation, and exercise, that helped to calm her nervous tice as a National Board-Certified Health & Wellness Coach. system and rewire her brain. A non-VA pain outcomes That esteemed credential represents training, education, questionnaire at 6 months revealed “greater functionaland assessment standards, allowing the profession to ity,” more engagement in “activities of daily living,” and advance in all aspects of healthcare and wellness. Estab- an overall decrease in pain. Coaching a person with pain lishing this board certification has contributed to Health can be a 1 step forward, 2 steps back process, so the initial & Wellness Coaching becoming more widely recognized engagement phase is critically important for the client to by insurers and other payers in the industry. know that their coach is on their side. Trust and rapport are essential and take time.

Tiffany learned to reframe her burning nerve pain from, “My nerves must be dying from the damage!” to “I can feel something, so my nerves must be healing!”

Reframing looks at the same situation in a different, more positive, and restorative way. For instance, “My pain is Pain management coaching is a specialty unbearable” can be reframed to “I’ve managed hard days within health and wellness coaching that relies heavily on before and know I can get through this.” The coach and the use of motivational interviewing, appreciative inquiry, client collaborate as the client employs tools like music, and positive psychology. Appreciative inquiry brings the mindfulness, gratitude, diaphragmatic breathing, and focus onto personal strengths, and positive psychology expressive writing. These tools work to engage the paraseeks to reframe one’s focus away from the negative aspects sympathetic nervous system, which decreases the “fight or of their experience onto what is working and going well flight” response to pain. The result is an overall decrease in their lives. We start with a nonjudgmental partnership in the experience of pain.

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“What

we focus on we empower and enlarge.

We have the power to change our brain’s responses to pain.”

Since utilizing reframing and several of the tools mentioned above, Tiffany has gained more function in her limbs and an overall increase in physical strength.

She began to see herself in more positive terms as “healthy, whole, and complete.” Through the coaching process, she found the support and tools she needed to manage her very real pain and improve her functionality. She still lives with pain, but after nearly 20 years of suffering, pain no longer controls her life.

While we revel in the stories, science demands the data. We were pleased to have our data studied and published in a recent issue of PLOS One. The study evaluated the intake, 6-month, and 12-month non-VA pain outcomes questionnaire data of 419 Take Courage Coaching participants who enrolled in our 1-year chronic pain management program.5 As the study showed, pain management coaching promises to be a useful intervention to improve pain-related outcomes in a population with chronic pain. The researchers concluded that our coaching program is “associated with clinically meaningful reductions in pain intensity” and “improved physiological and physical pain-related functioning.”5 They wrote that more research should be done on this powerful method and we are enthusiastically pursuing more and more thorough studies.

Pain management coaching works for all types of pain conditions because it centers on what the client has within their control and the process of rewiring the brain and nervous system for a decreased pain experience. Our coaches have zero fear when working with even the toughest clients because they know that the

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contagious courage and empowerment the client receives from the relationship can help even the most severe cases move forward.

In our experience coaching hundreds of chronic pain clients, we have found that harnessing the power of the brain is essential to achieving the best outcomes. Please understand that I’m just as appreciative of the work done in the area of analgesia as the next surgery patient, but when it comes to the average chronic pain patient there’s so much going on in the brain that has little to do with nociceptors or dorsal horns. Chronic pain patients aren’t crazy, but they have powerful minds that sometimes get them into trouble and may need to be redirected to recovery. Let’s give those powerful minds something to do besides agonizing over the next pain flare.

References 1. Garland EL. Pain processing in the human nervous system: a selective review of nociceptive and biobehavioral pathways. Prim Care. 2012;39(3):561–571.

2. Egger G, Binns A, Rossner S. Lifestyle Medicine: Managing Diseases of Lifestyle in the 21st Century. 2nd Ed. McGraw-Hill, Australia. 2011:2593.

3. On Chronic Pain, Neuroplasticity, and Trauma-Informed Pain Care. Podcast.

Available at: getbetteronline.co.uk/chronic-pain-neuroplasticity-and-trauma-informedpain-care/.

4. Pohl M, Curtis B. Icebergs, oceans, and the experience of pain. PWJ. 2019;7(4):20–28.

5. Rethorn ZD, Pettitt RW, Dykstra E, et al. Health and wellness coaching positively impacts individuals with chronic pain and pain-related interference. PLOS One. 2020;15(7):e0236734. Available at: doi.org/10.1371/journal.pone.0236734.

education is the best analgesic.

By Nikitha Pothireddy BS Anna Ruby-Trzeciak Courtney Brennaman MS Anureet Walia MBBS Beth L. Dinoff PhD

A Case Study

Sandy is a former high school track star. In high school, she sustained more sports injuries than her classmates, but her coach, primary care provider, and parents were not particularly concerned about them. After all, Sandy’s mother also had several injuries while playing basketball in high school. Sandy went to university under a full-ride track scholarship; however, her track career ended prematurely after several painful subluxations of her right knee. Unfortunately, that was not Sandy’s only concern. Around the same time, her ongoing gastrointestinal dysmotility symptoms prompted her primary care provider to refer Sandy to the gastroenterology clinic.

Soon after, Sandy established care with a cardiologist for her bouts of dizziness and syncopal spells. Several years later, Sandy was sent to a physical therapist for pelvic floor dysfunction and a chronic pain clinic for her presumed fibromyalgia symptoms.

These healthcare specialists noticed that Sandy’s symptoms sounded a lot like having chronic stress, so she was referred for psychotherapy to learn healthy and sustainable coping skills. Sandy began to worry that her healthcare providers thought her symptoms were all in her head. Now, Sandy visits her pain psychologist and demands to know why all of this is happening to her. She is hoping for a diagnosis that could tie all her symptoms together. In addition, she recalls her mother also having life-long joint pains, and she wants to know if this condition is genetic, to help her think about her own family planning goals. Sandy is unaware of the medical condition called painful hypermobile Ehlers Danlos syndrome, a common connective tissue disorder.

She has never heard of postural orthostatic tachycardia syndrome, an ailment with which it often co-occurs. It could take years for Sandy to have a confirmed diagnosis of either or both because these symptoms are frequently misdiagnosed.

Abstract

Even with a proper diagnosis, conditions such as the ones described in the Case Study are often undertreated or mistreated for more than a decade, possibly secondary to segregated management of common symptoms. Together, a diagnosis of painful hypermobile Ehlers Danlos syndrome (hEDS) with postural orthostatic tachycardia syndrome (POTS) could easily explain Sandy’s multiple health issues. The frequency of comorbid hEDS and POTS may stem from a physiological shared vulnerability of the conditions. In this article, we hope to bring to light how Sandy’s complex symptoms could fall under the broad umbrella of hEDS, specifically painful hEDS in conjunction with POTS, in adults. We will highlight some of the scientific evidence for the shared vulnerability between these two conditions and explore treatment options.

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key topic

Ehlers Danlos Syndrome

Ehlers Danlos syndrome (EDS) is a connective tissue disorder. Connective tissue is distributed throughout the human body to help with energy storage, insulation, and transporting substances. These tissues are comprised of two proteins: collagen and elastin. Connective tissues, such as cartilage, skin, ligaments, tendons, body fat, blood vessels, and bone, play an important role in supporting, connecting, and separating the epithelial, muscle, and nervous tissues of the body. Another important role of connective tissue is maintaining the framework between organ systems and providing structural support to the body’s architecture. Often, connective tissue diseases inflame the collagen and elastin leading to potential damage to the involved organs and body systems. Many connective tissue disorders are also autoimmune disorders, such as rheumatoid arthritis, scleroderma, and lupus. Two connective tissue disorders that have well-identified genetic markers are Marfan syndrome and EDS. EDS is a family of largely inherited disorders linked specifically to genetic mutations in collagen that primarily result in changes to the skin and joints. Unfortunately, the pathogenesis of EDS within the collagen is poorly understood. EDS may also impact specific organs depending upon the type of EDS, some with severe consequences, such as organ rupture.1 Thirteen different types of EDS have been recognized within the International EDS Consortium

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classification system, most of which may be verified through genetic testing.2 Many variants of EDS involve autosomal (ie, not sex-linked) dominant inheritance and others involve autosomal recessive inheritance. A recent study in the UK indicated that the prevalence of EDS may be as high as 10 cases per 5000 patients, with a much higher prevalence in females compared to males.3 In fact, 70% of the cases are diagnosed in females, and only 30% are diagnosed in males4; however, EDS is as severe and disabling in men as it is in women. People engaged in family planning may benefit from understanding that people who have autosomal dominant EDS are at 50% risk of having a child with EDS; however, people who have autosomal recessive EDS are only at 25% risk of having a child with EDS.5 Referral for genetic counseling may be beneficial for understanding inheritance patterns, as well as family planning. EDS subtypes include classical, classic-like, cardiac valvular, vascular, kyphoscoliotic, brittle cornea syndrome, periodontal, and hypermobile.

Symptoms of EDS vary depending upon the subtype of EDS. Regardless of EDS type, the most frequently diagnosed symptoms are joint hypermobility, skin hyperelasticity, and easy bruising. Hypermobile Ehlers Danlos syndrome is believed to be the most recognized and least severe type of EDS; yet no genetic markers have been verified.1 Currently, the diagnosis of hypermobile EDS is exclusively based upon a checklist for the clinical presentation. The checklist is available on our website at pain.sh/9pa.

Hypermobile Ehlers Danlos Syndrome

The signature symptom of hEDS is age-linked hypermobility. Children are more likely to present with clear hypermobility as joint flexibility decreases with age.1 Regardless of age, hypermobility may result in loose and unstable joints, leading to dislocations and subluxations in both axial and peripheral joints.1 Not uncommonly, patients with hEDS undergo repetitive surgeries to repair and restore use to dysfunctional joints. People with hEDS are also at risk for having scoliosis, Chiari malformation, or early onset osteoporosis.6 hEDS may lead to changes in the skin structure giving it a velvety texture, a thin or translucent appearance, and hyperextensible elastic properties. These changes may result in increased prominence of veins under the skin and a delay in the skin’s return to its former shape when stretched. Other skin symptoms include unusual scarring, developing stretch marks at a young age, increased susceptibility to bruising or bleeding, and slow healing wounds. Psychological symptoms of depression, eating disorders, and substance abuse are more common in people with hEDS than other types of EDS.1 Psychosocial variables likely play an important role in the maintenance of chronic pain in people with hEDS. Fear avoidance, or restricting activity out of fear of experiencing increased pain during or after an activity, may lead to depression, anxiety, and/or disability. Scheper et al suggest that fear of pain can result in avoidance of muscle contractions followed by suboptimal muscle activity and reduced joint stability.7 Sexual dysfunction, painful intercourse, and menorrhagia have been identified in people with hEDS.8 In addition, the clinical description of hEDS includes chronic fatigue, gastrointestinal disorders, dysautonomia, headaches, and fibromyalgia.3

be caused by structural changes in musculoskeletal tissues, such as joint dislocation or attempts at surgical repair of damaged tissues. Neuropathic pain—caused by damage to the tissues of the nervous system—may be characterized by burning, stinging, numbness, or tingling. In people with hEDS, neuropathic pain may be secondary to proprioception impairment or central sensitization.

Scheper and colleagues (2015) hypothesized that both biomechanical and physical determinants would play a role in musculoskeletal pains in people with hEDS.7 They suggested that mechanical overload or soft tissue laxity could lead to a heightened risk of repetitive injuries during routine activities. Such microtraumas could lead the individual to make adaptations in body mechanics, thereby transferring the overload to another part of the body. This transfer of load may be seen in pain behaviors of splinting, bracing, and restricted range of motion. Deconditioning, changes in proprioception, and reflex inhibition may also be factors in the development of chronic pain in people with hEDS. These factors have been found to lead to decreased muscle strength, increased muscle atrophy, and reduced muscle endurance. Scheper et al (2015)7 report that generalized hyperalgesia was recently identified in people with hEDS. Central sensitization, or upregulation of the central nervous system, may lead to lowering of pain thresholds during pain flare-ups.

According to Scheper and his team, central sensitization may serve as an adaptive or protective compensatory tool to reduce repetitive injury. In their 2015 study on central sensitization in a very small sample of people with hEDS, Scheper et al found reduced cold and heat pain thresholds as well as increased wind-up ratios. The authors propose that chronic nociceptive input triggers central sensitization within dorsal horn neurons.7

Painful Hypermobile Ehlers Danlos Syndrome

The International EDS Consortium 2017 diagnostic criteria for hEDS identifies chronic musculoskeletal pain as an important diagnostic criterion.1 hEDS-related musculoskeletal pains include: pain in ≥2 limbs for ≥3 months or longer, chronic pain throughout the body for ≥3, and reoccurring nontraumatic joint instability or dislocations. Differential diagnoses must be ruled out prior to making the hEDS diagnosis. The prevalence of hEDS with associated chronic pain is believed to be around 41%, with a range of 2% to 89%.7 Although the precise pathway for developing pain in the context of hEDS has not been identified, both nociceptive pains and neuropathic pains have been recognized clinically.2 Nociceptive pain—caused by damage or potential damage to the body—may be experienced as sharpness, aching, throbbing, or tenderness.

In the case of hEDS, chronic nociceptive pain may be the result of articular or nonarticular symptoms associated with joint hypermobility. In addition, nociceptive pain may

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Painful hEDS-Associated Postural Orthostatic Tachycardia Syndrome

As noted above, another symptom of painful hEDS is dysautonomia. Dysautonomia describes a cluster of disorders caused by dysfunction within the autonomic nervous system, affecting millions of people annually. The autonomic nervous system controls the body’s automatic, involuntary, or unconscious actions and processes. Blood pressure, heart rate, breathing, body temperature, sexual arousal, and digestion are maintained by the autonomic nervous system.3 The most common types of dysautonomia are neurocardiogenic syncope, autonomic dysreflexia, multiple system atrophy, familial dysautonomia, diabetic autonomic neuropathy, complex regional pain syndrome, and orthostatic intolerance. Postural orthostatic tachycardia syndrome (POTS) is a type of orthostatic intolerance that impacts blood flow when moving to the upright position from a seated or reclining position; these symptoms must be reproducible and sustained over time

to be diagnosed as POTS.9 Orthostatic intolerance encompasses a diverse set of symptoms—including palpitations, dizziness, visual changes, tremulousness, nausea, and impaired concentration,10—that result from an abnormal response to standing up. These symptoms generally resolve by returning to a supine position.11 POTS is defined as a sustained heart rate of greater than 30 beats per minute or an increased heart rate to 120 beats, occurring within 10 minutes of rising from a supine position.12 The prevalence of POTS is unknown; however, approximately 3,000,000 Americans or roughly 1% of the population are estimated to meet diagnostic criteria.13,14 Many more females (77%) than males have been diagnosed with POTS.15 A strong association between POTS and hEDS has been identified. Although the exact prevalence of comorbid POTS and hEDS is not well known, several studies report 40% or higher POTS diagnoses in their hEDS samples.16,17 Roma et al (2018) indicated that up to two-thirds of people with hEDS also experience general orthostatic intolerance or POTS specifically.18 Another study reported that over 74% of people with hEDS demonstrated POTS and orthostatic intolerance as compared to only 34% of nonhEDS controls.19 More than 30% of people with POTS met diagnostic criterial for hEDS.

Shared vulnerability of painful hEDS and POTS

Although painful hEDS and POTS are currently seen as unique syndromes, we raise the question: Is there a shared vulnerability for painful hEDS and POTS? The answer will not be forthcoming because the existing science does not fully articulate the precise pathophysiology of either condition independently. So, let’s start with what we do know about the similarities and links between hEDS and POTS. As previously discussed, painful hEDS and POTS frequently co-occur. Painful hEDS and POTS have several overlapping symptoms including tachycardia, fatigue, migraines, bladder control issues, dizziness, vomiting, myofascial pain, temperature intolerance/sweating changes, digestive problems, anxiety, depression, and sleep disruption. A review of the medical research literature shows other interesting links between painful hEDS and POTS or POTS-like symptoms. For example, dysautonomia leads to higher baroreflex sensitivity in people with POTS and hEDS. Baroreflex sensitivity affects blood pressure regulation and can result in the symptoms commonly seen in both hEDS and POTS (such as fainting and dizzy spells.3,4 In addition, fatigue severity in people with hEDS may be determined by their degree of orthostatic intolerance.20 POTS may also be an independent predictor of gut dysmotility in people with hEDS.21 GI disorders are more prevalent in people with both POTS and hEDS compared to those with hEDS alone.22 In a 2020 retrospective study on predictors of GI dysmotility in people with hEDS, over 60% of people reported ≥1 GI symptom at the time of their hEDS

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diagnosis.21 Psychological factors may also play a role in the shared vulnerability between painful hEDS and POTS. People with both hEDS and POTS generally have higher depression and anxiety scores than POTS-negative hEDS people.22 Increased pain catastrophizing and decreased social functioning have been identified more frequently in people with hEDS and POTS in comparison to people having hEDS without POTS.23 De Wandele and colleagues (2016 )19 explored the underlying mechanisms of dysautonomia in a small sample of people with hEDS by administering both cardiovascular and sudomotor tests. They found that people with hEDS demonstrated increased sympathetic activity while at rest and decreased sympathetic reactivity in response to physical stimuli as compared to age-matched controls without hEDS. Researchers suggest that peripheral neuropathy may be the common factor between hEDS and dysautonomia given that the sympathetic nerves may be sufficiently impaired, and vasoconstriction may be compromised. De Wandele and colleagues also note that, if the sympathetic nerves are impaired, compensatory tachycardia may be required to maintain cardiac output. Other possible links include: a) increased collagen laxity in blood vessels of people with hEDS that could lead to venous pooling and increased heart rate; b) medication-related iatrogenic complications: several medications that are used to ameliorate symptoms of hEDS also impact vasomotor regulation, including opioids, blood pressure lowering agents, and tricyclic antidepressants; and c) depression, physical deconditioning, and pain-related sympathetic arousal may also contribute to the development of dysautonomia symptoms.

Mechanisms of shared vulnerability have been explored for pain and posttraumatic stress disorder, creativity and psychopathology, obesity and addiction, and epilepsy and autism. Identification of shared vulnerabilities between painful hEDS and POTS could help identify more effective treatments, lead to the development of prevention or amelioration strategies, allow patients with these comorbid conditions to be diagnosed earlier in the course of these syndromes, and reduce the impact of psychosocial stressors that lead to anxiety, depression, and disability.

Treatment of Symptoms of Comorbid Painful hEDS and POTS

Here are global treatment suggestions for people afflicted with both of these complex and inadequately understood conditions. We strongly recommend that anybody who is seeking treatment for painful hEDS and/or POTS consult with their own healthcare team to ensure that they receive the most evidence-based treatment options for their specific set of symptoms.

Clearly, the treatment of comorbid painful hEDS and POTS has proven challenging given the multifaceted clinical presentation of people with POTS-positive hEDS. When someone has pain secondary to combined hEDS and POTS, an interdisciplinary approach involving medical evaluation and treatment, psychotherapy, physical therapy, genetic counseling, dietary modifications, lifestyle changes, and pharmacological treatment is optimal.24 Multiple medical specialties may be consulted by a primary care provider to treat the comorbid conditions of painful hEDS and POTS, including cardiology, pain medicine, physiatry, orthopedics, and sports medicine. Patients can become overwhelmed with the frequent appointments, and they may benefit from having a trusting relationship with their primary care provider or a case manager. People with chronic pain may benefit from pain psychology to learn how to live a valued life in the context of chronic pain. Pain psychology can also enhance adherence to lifestyle modifications, such as wearing compression garments and following through with physical activity goals. Associated depression and anxiety may also be addressed in pain psychotherapy or through referral to psychiatry. Physical therapy can help people navigate their hypermobility while also teaching skills to reduce physical deconditioning secondary to POTS. Postural awareness and education about body mechanics have shown marked improvement in ability to engage in activities of daily living in people with hEDS.23 Physical therapists trained in the treatment of comorbid painful hEDS and POTS will recognize that treatments that work for one person may not work for another due to varying degrees of orthostatic intolerance. Dietitians may be consulted to help increase water and salt intake in keeping with people’s eating preferences. Consultation with a clinical pharmacist will be very helpful when making complicated medication decisions.

Conclusions

Painful hEDS is often overlooked in its early stages resulting in misdiagnosed chronic fatigue, fibromyalgia, anxiety, irritable bowel syndrome, or other similar conditions. Reduction in hypermobility with age also makes diagnosis of EDS in later stages more difficult. Delays in diagnosis can lead to the development of maladaptive coping strategies as well as a more difficult management journey. Treatment adherence in people who have POTS-positive hEDS can be diminished due to the inconsistent success rates of different management regimens. For this reason, therapies should be personalized to the person’s tolerance level. Because there is no gold standard option for pharmacological or nonpharmacological treatment, the journey to find the right management combination can be an arduous one. Most people with painful hEDS go on to live healthy lives; however, the quality of life may be diminished by orthostatic intolerance, disorders

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related to GI or bladder function, myofascial pain, psychiatric disorders, chronic headaches, and disability. A disjointed healthcare network may increase the difficulty of making the connection between the constellation of symptoms found in people with comorbid painful hEDS and POTS. Improving interdisciplinary communication will help significantly with screening and management of symptoms in people with painful hEDS and POTS. A limited literature exists examining the relationship between painful hEDS and POTS. The fluidity of the criteria that define these syndromes emphasizes the need for more research on the underlying causes and clinical presentation of people with both syndromes.

The concept of shared vulnerability highlights the importance of not looking at symptoms in isolation. In the case of comorbid painful hEDS and POTS, when the symptoms are treated in a disjointed fashion, the true underlying causes may remain masked. By training healthcare professionals to detect concomitant hEDS and POTS in pediatric and adult populations, we may improve early detection and treatment of these conditions. Additionally, increasing public awareness of the amalgamation of symptoms that make up painful hEDS and POTS is pertinent.

A Case Study (conclusion)

With increased awareness, Sandy’s coaches, parents, and primary care provider might have been able to get her the help and guidance she needed sooner. Early intervention may have prevented Sandy’s career ending injury and improved her overall quality of life substantially. Sandy is just one of many when it comes to people who have been detrimentally impacted by painful hEDS and POTS.

References

13. Garland EM, Celedonio JE, Raj SR. Postural tachycardia syndrome: beyond orthostatic intolerance. Curr Neurol Neurosci Rep. 2015;15(9):60.

1. Islam M, Chang C, Gershwin ME. Ehlers-Danlos syndrome: immunologic contrasts and connective tissue comparisons. J Transl Autoimmun. 2020;4:100077.

14. Raj SR. Postural tachycardia syndrome (POTS). Circulation. 2020;127(23): 2336–2342.

2. Syx D, De Wandele I, Rombaut L, et al. Hypermobility, the Ehlers-Danlos syndromes and chronic pain. Clin Exp Rheumatol. 2017;116–122. Available at: www.clinexprheumatol.org/article.asp?a=12220.

15. Boris JR, Bernadzikowski T. Demographics of a large paediatric postural orthostatic tachycardia syndrome program. Cardiol Young. 2018;28:668–674.

3. Demmler JC, Atkinson MD, Reinhold EJ, et al. Diagnosed prevalence of Ehlers-Danlos syndrome and hypermobility spectrum disorder in Wales, UK: a national electronic cohort study and case-control comparison. BMJ Open. 2019;9(11):e031365.

16. Celletti C, Camerota F, Castori M, et al. Orthostatic intolerance and postural orthostatic tachycardia syndrome in joint hypermobility syndrome/Ehlers-Danlos syndrome, hypermobility type: neurovegetative dysregulation or autonomic failure?

Biomed Res Int. 2017;2017:9161865.

4. Castori M, Camerota F, Celletti C, et al. Ehlers-Danlos syndrome hypermobility type and the excess of affected females: possible mechanisms and perspectives.

Am J Med Genet A. 2010;152a(9):2406–2408.

17. Miller AJ, Stiles LE, Sheehan T, et al. Prevalence of hypermobile EhlersDanlos syndrome in postural orthostatic tachycardia syndrome. Auton Neurosci.

2020;224:102637.

5. UW Orthopaedics and Sports Medicine. Ehlers-Danlos syndrome. Available at: orthop.washington.edu/patient-care/articles/arthritis/ehlers-danlos-syndrome.html.

6.

18. Roma M, Marden CL, De Wandele I, et al. Postural tachycardia syndrome and other forms of orthostatic intolerance in Ehlers-Danlos syndrome. Auton Neurosci.

2018;215:89–96.

The Ehlers-Danlos Support UK. (n.d.). https://www.ehlers-danlos.org/.

7. Scheper MC, de Vries JE, Verbunt J, et al. Chronic pain in hypermobility syndrome and Ehlers-Danlos syndrome (hypermobility type): it is a challenge.

J Pain Res.,2015;8:591–601.

19. De Wandele I, Rombaut L, De Backer T, et al. Orthostatic intolerance and fatigue in the hypermobility type of Ehlers-Danlos syndrome. Rheumatology (Oxford).

2016;55(8):1412–1420.

8. Tinkle B, Castori M, Berglund B, et al. Hypermobile Ehlers-Danlos syndrome (a.k.a. Ehlers-Danlos syndrome type III and Ehlers-Danlos syndrome hypermobility type): clinical description and natural history. Am J Med Genet C Semin Med Genet.

2017;175(1):48–69.

20. Alomari M, Hitawala A, Chadalavada P, et al. Prevalence and predictors of gastrointestinal dysmotility in patients with hypermobile Ehlers-Danlos syndrome: a tertiary care center experience. Cureus. 2020;12(4):e7881.

21. Bulbena A, Baeza-Velasco C, Bulbena-Cabré A, et al. Psychiatric and psychological aspects in the Ehlers-Danlos syndromes. Am J Med Genet C Semin Med Genet.

2017;175(1):237–245.

9. Olshansky B, Cannom D, Fedorowski A, et al. Postural orthostatic tachycardia syndrome (POTS): a critical assessment. Prog Cardiovasc Dis. 2020;63(3):263–270.

10. Stewart JM. Common syndromes of orthostatic intolerance. Pediatrics.

2013;131(5):968–980.

22. Baeza-Velasco C, Bourdon C, Montalescot L, et al. Low- and high-anxious hypermobile Ehlers-Danlos syndrome patients: comparison of psychosocial and health variables. Rheumatol Int. 2018;38(5):871–878.

11. Di Stefano G, Celletti C, Baron R, et al. Central sensitization as the mechanism underlying pain in joint hypermobility syndrome/Ehlers-Danlos syndrome, hypermobility type. Eur J Pain. 2016;20(8):1319–1325.

23. Zhou Z, Rewari A, Shanthanna H. Management of chronic pain in EhlersDanlos syndrome: two case reports and a review of literature. Medicine (Baltimore).

2018;97(45):e13115.

12. Celletti C, Borsellino B, Castori M, et al. A new insight on postural tachycardia syndrome in 102 adults with hypermobile Ehlers-Danlos Syndrome/hypermobility spectrum disorder. Monaldi Arch Chest Dis. 2020;90(2).

24. Mar PL, Raj SR. Postural orthostatic tachycardia syndrome: mechanisms and new therapies. Annu Rev Med. 2020;71:235-248.

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E

CP PS, C B MS, PE mD, rmD, C r Pha ha ger tsky P i e a G Uri ssic ya J. e J

By Tan

and state guidelines exclude special populations from their recommendations for safe prescribing of opioids.

Specifically, patients with sickle cell disease (SCD), those with active cancer, and those receiving palliative care are exempt from these standards. Despite this exemption from the guidelines, the care of patients with these conditions is significantly impacted because of overgeneralization, limits that must be over-ridden, and an increased concern about stigma that drives fear and self-management of pain. Elements of safe prescribing and use of opioids should apply regardless of the situation, while simultaneously ensuring adequate pain management and access to necessary medications.

Rather than limiting prescribing, the focus should be on education, de-stigmatization, and access. Clinicians should be fueled with resources to empower patients to achieve adequate pain management and balance that with safe use. In order to delve into these exceptions, we first need to briefly discuss opioid stewardship.

Elements of safe prescribing and use of opioids should apply regardless of the situation, while simultaneously ensuring adequate pain management and access to necessary medications. Rather than limiting prescribing, the focus should be on education, de-stigmatization, and access.

Opioid Stewardship

opioid epidemic with education across the board from patients to physicians to family members to nurses and any other staff members involved in a patient’s care, combat it with directed initiatives and supporting collaborations between departments, and 3) to improve clinical outcomes for our patients in regards to their pain management and opioid risk and misuse.

The Institute for Safe Medication Practices Canada describes opioid stewardship as “coordinated interventions designed to improve, monitor, and evaluate the use of opioids in order to support and protect human health.”1 While opioid stewardship is a relatively new concept, the principles have been modeled after antimicrobial stewardship programs, which have been around in practice for years.2 As many of us are aware, antimicrobial stewardship programs were initiated to address antimicrobial misuse and resistance patterns that were emerging, and have been so widely successful that these programs are now required for Joint Commission-accredited hospitals in the United States. So, if history is any indication of what is to come, opioid stewardship may well become a required program. Because of this, I think it is important that we understand the goals of a stewardship program and highlight initiatives that can be implemented at your own institution.

The National Quality Forum created a National Quality Partners Playbook: Opioid Stewardship edition in March 2018 that provides both strategies and implementation examples for healthcare organizations wanting to develop an opioid stewardship program.3 The playbook aligns with 2016’s Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain, but additionally provides broader guidance on stewardship by identifying fundamental actions of opioid stewardship: 1) promote leadership commitment and culture, 2) implement organizational policies, 3) advance clinical knowledge, expertise, and practice, 4) enhance patient and family caregiver education and engagement, 5) track, monitor, and report performance data, 6) establish accountability, and 7) support community collaboration.

Many hospitals have multiple individuals in different areas and units working on various opioid and painrelated projects, but the addition of an opioid stewardship team and program can facilitate the formation of an oversight group to encourage collaboration, help organize and prioritize these projects, and overcome barriers for project completion. The overall goals for opioid stewardship can be summarized as 1) to ensure regulatory compliance with governing bodies like the Joint Commission, state and federal laws, and evidence-based practices, 2) to combat the

Sickle Cell Disease

SCD is a congenital chronic hemolytic disorder that is frequently interrupted by acute life-threatening events. The incidence in newborn American Blacks is 1 in 400. Acute complications of sickle cell include acute chest syndrome

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disease. This cancer pain generally presents as a mixed picture: nociceptive, neuropathic, and inflammatory.7 Treating this pain can require high doses of opioids, along with nonopioid medications such as steroids and gabapentinoids.

and pain crisis. Symptoms of acute chest syndrome include fever, chest pain, infiltrates, and splenic sequestration. Chronic complications include hemolytic anemia, skin ulceration, stroke, aneurism, splenic infarcts, renal failure, hepatic dysfunction, priapism, avascular necrosis, and retinopathy.4

The National Comprehensive Cancer Network guidelines for adult cancer pain recommends the following: 1) use goal setting; 2) complete a comprehensive assessment; 3) use a multimodal pain approach; 4) use the lowest effective opioid dose; 5) use scheduled, and breakthrough doses, based on 24-hour use, and 6) decrease the dose only if able.8 The comprehensive assessment should include a prescription drug monitoring program review, risk/benefit assessment, opioid contracts as appropriate, and a pain assessment.

The average patient with SCD has 3 emergency department (ED)/hospital admissions per year. The American Society of Hematology recommends the use of standardized protocols to treat acute pain in the acute care setting, including the use of nonopioid pharmacologic therapies for acute pain, nonpharmacologic therapies for acute pain; management of pain in SCD-specific hospital-based acute care facilities; and use of patient controlled analgesia as appropriate.4 For adults and children with SCD presenting to an acute care setting with acute pain related to SCD, rapid (≤1 hour of ED arrival) assessment and administration of analgesia with frequent reassessments (every 30–60 minutes) to optimize pain control are recommended. When opioids are indicated, tailored opioid dosing is recommended, based on consideration of baseline opioid therapy and prior effective therapy.5

Cancer Survivorship

The American Society of Clinical Oncology published guidance on treating pain in cancer survivorship.9 These guidelines recommend a comprehensive pain assessment, multimodal pain therapies, a risk/benefit analysis, and tapering of opioids only if they are no longer warranted.

The comprehensive assessment includes screening for chronic pain syndromes that result from cancer treatments and to evaluate for recurrent disease. Multimodal therapies should include pharmacologic and nonpharmacologic therapies and using opioids when a patient is nonresponsive to other treatments.

Active Cancer/ Palliative Care

The CDC Guideline stressed appropriate assessment, dosing, treatment duration, and risk/benefit assessment.6 The guideline also suggested morphine milligram equivalent (MME) thresholds. Patients requiring ≥50 MME should receive careful reassessment at each follow-up visit and doses ≥90 MME should be avoided without justification.

The guideline carved out an exception for hospice, palliative care, and patients being seen by a pain specialist, as these patients can often require more than the recommended thresholds of the guideline. However, the guideline has had some unintended consequences for patients with active cancer, specifically, delays in patient care and disruptions in treatment plans. There might be an unintended consequence, for example, with a plan initiated in the hospital and a follow-up appointment scheduled. But on discharge, however, the patient is not prescribed enough pain medication to last until their follow-up appointment.

All the guidelines included in this article recommend the following:

1 Use nonpharmacologic and nonopioid pharmacologic therapies 2 Assess the individual’s likely benefit and risk prior to initiating opioid treatment 3 Development and implementation of strategies to maintain patient safety and minimize risk of opioid misuse based on patient history and risk factors 4 Continuous monitoring and regular evaluations of effectiveness and necessity of opioid therapy 5 Patient education on goals, treatment, and safer use of opioid analgesics 6 Optimization of adjuvant analgesics, psychosocial support, and interventional therapies in conjunction with opioid therapy 7 Gradual opioid dose reduction, when indicated, to prevent withdrawal symptoms

Insurance companies have introduced red tape to the situation as well, in the form of prior authorizations and failure plans where a patient must fail treatments before they can move on to other therapeutic options. This red tape has caused an increased workload for providers, and a delay in patients accessing medications.

The guidelines do not prohibit the use of opioids. They state that they should be used in the right patient at the lowest effective dose for an appropriate duration of time.

Cancer pain affects 30% to 50% of patients receiving active treatment and >70% of those with advanced

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Ongoing risk/benefit analysis is important in all patient populations. As pain clinicians, we cannot forget about the outliers of the CDC guideline—sickle cell disease, active cancer treatment, and cancer survivorship. Opioids might not always be the answer…but sometimes they are.

References 1. Opioid Stewardship. Institute for Safe Medicine Practices Canada website.

Available at: www.ismp-canada.org/opioid_stewardship/.

2. CDC. Core elements of hospital antibiotic stewardship programs. Atlanta, GA: US Department of Health and Human Services. 2019. Available at: www.cdc.gov/ antibiotic-use/core-elements/hospital.html.

3. Friedhelm S, Uppal R. The time for opioid stewardship is now. Jt Comm J Qual Patient Saf. 2019; 45:1–2.

4. Brandow AM, Carroll CP, Creary S, et al. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Blood Adv. 2020;4(12):2656–2701. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC7322963.

5. Field JJ, Ballas SR, Campbell CM, et al. AAAPT diagnostic criteria for acute sickle cell disease pain. J Pain. 2019; 20(7):746–759.

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

7. Dalal S, Bruera E. Pain management for patients with advanced cancer in the opioid epidemic era. Am Soc Clin Oncol Educ Book. 2019;39:24–35.

8. National Comprehensive Cancer Network. Adult Cancer Pain (version 1.2020).

Available at: www.nccn.org/professionals/physician_gls/pdf/pain.pdf.

9. Paice JA, Portenoy R, Lacchetti C, et al. Management of chronic pain in survivors of adult cancers: American Society of Clinical Oncology Clinical Practice Guideline.

J Clin Oncol. 2016;34(27):3325-3345.

PAINWEEK’21 CONFERENCE PREVIEW P.74

By Kevin L. Zacharoff MD, FACIP, FACPE, FAAP

Knowledge of the patient’s current pain intensity is important, as are pain intensity ratings over time. Questions about pain intensity generally include a timeline (usually from a week to a month), a parameter (average, least, most), and a rating of pain. Asking about the least and most pain that the patient has experienced over some definable period can establish whether a range of pain levels and variation of pain exist.

UNIDIMENSIONAL SCALES

This rating scale is commonly used and generally considered easy to understand. This scale can be administered visually or verbally, including over a telephone or telehealth visit, which may be useful during the dosage titration process.

Two common assessment instruments that can be used to measure pain intensity are the visual analogue scale and the numerical rating scale.

What is the intensity of your pain right now?

0

Visual Analogue Scale

The visual analogue scale (VAS)1 is a 10-cm line with anchors at both ends. Common anchors are 0 “No pain” and 100 “Worst pain.” Patients are asked to draw a vertical line through the horizontal line to indicate their pain intensity. The line is measured in millimeters, yielding a number between 0 and 100. Research has confirmed the sensitivity, validity, and reliability of the VAS scale.2 An example (not shown to scale) is shown below: What is the intensity of your pain right now?

0 No pain

Worst pain

Numerical Rating Scale

The numerical rating scale (NRS), sometimes referred to as a verbal rating scale (VRS), is an 11-point scale on which patients rate the intensity of their pain by choosing a number from 0 “No pain” to 10 “Pain as bad as it could be.”

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1 No pain

2

3

4

5

6

7

8

9

10

Pain as bad as it could be

Some clinicians prefer the VAS because of certain theoretical psychometric advantages: it takes a bit more thought to attribute a rating between 0 and 100 than it does 0 to 10.

Other clinicians prefer the NRS because, compared to the VAS, they find it is easier to score, fewer patients fail to understand its usage, and for practical purposes the psychometric properties work well. A survey of 85 chronic pain patients was performed using both the VAS and NRS (or verbal rating scale).3 The results of this survey concluded that comparatively, “the [verbal rating scale] is a simple instrument that can save time and compares favorably to the VAS.” Some suggestions for increasing the ease with which patients use the numerical rating scale have been proposed3 and are also useful in explaining the VAS. Regardless of which scale is utilized, it should be explained each time it is administered, and patients should be taught how to use the scale. Patients should be taught that a “10” rating means the worst possible pain. This understanding can

MULTIDIMENSIONAL TOOLS

assist in trying to help reduce the exclusive use of the higher end of the scale and increase the practical application of the measurement. Additional aids can be used to ensure that the patients with hearing or visual difficulties can use the measure with relatively little difficulty. In addition, a quiet and calm place should be provided for the completion of this instrument, and the patient should be allowed to ask questions which could potentially influence their selection about how much pain they are in.4

Multidimensional pain assessment tools provide information about the pain’s characteristics and impact on daily life.

The following are examples of commonly used multidimensional tools for pain assessment in use today.

McCaffrey Initial Pain Assessment Tool

CATEGORICAL SCALES

Below are examples of verbal categorical scales that provide a simple means for patients to rate their pain intensity using verbal or visual descriptions of their pain.

Simple Descriptive Pain Intensity Scale No pain

Mild pain

Moderate pain

Severe pain

Very severe pain

Worst possible pain

Faces Pain Scale – Revised (FPS-R)5

Instructions for use of the Faces Pain Scale – Revised read as follows: “These faces show how much something can hurt. This face [point to left-most face] shows no pain. The faces show more and more pain [point to each from left to right] up to this one [point to right-most face] – it shows very much pain. Point to the face that shows how much you hurt [right now].” This tool is available in several languages, and information regarding conditions for permission of its use at no cost, along with instructions for use, are available at: pain.sh/q6r.

These unidimensional and categorical pain rating scales remain useful screening tests that should be supplemented frequently by a more detailed assessment.

The McCaffrey Initial Pain Assessment Tool6 was developed for the initial patient pain evaluation and provides a good example of a structured initial pain assessment checklist.

This tool includes a diagram of different body locations so that the patient can also mark the areas that correspond to the location of his or her pain. In addition, the following topics are covered in the evaluation of the intensity of pain: ○ Quality of pain (in the patient’s own words) ○ Onset ○ Duration ○ Variations ○ Presence of rhythmic nature ○ Manner of expression of pain ○ What, if anything, relieves the pain? ○ What causes or increases the pain? ○ The impact the pain has on the patient ○ Accompanying symptoms ○ Sleep ○ Appetite ○ Physical activity ○ Interpersonal relationships ○ Emotional state ○ Ability to concentrate ○ Any other pertinent points of information ○ Care plan

Brief Pain Inventory

The Brief Pain Inventory7 is easy to use and helps to quantify pain intensity and interference with a patient’s life. Patients rate their pain severity at its worst, least, and average

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during the past week and at the time of assessment (“right now”). Brief pain inventory items include the following: ○ A diagram of a front and back view of a human figure to identify the location of pain ○ A rating of the amount of relief the patient feels that the current pain treatments (if any) provide ○ A rating of the duration of the patient’s pain relief after taking prescribed pain medications ○ An assessment of the patient’s attribution of pain to the disease, the treatment of the disease, or conditions unrelated to the disease

primarily of 3 major classes of word descriptors—sensory, affective, and evaluative—that are used by patients to specify their subjective pain experience. It also contains an intensity scale and other items to determine the properties of the pain experience.

The questionnaire was designed to provide quantitative measures of clinical pain that can be treated statistically.

The major measures are the following:

1 The pain rating index, based on 2 types of

numerical values that can be assigned to each word descriptor 2 The number of words chosen 3 The present pain intensity based on a 1–5 intensity scale

Patients also rate their level of pain interference in the following contexts from 0 (“Does not interfere”) to 10 (“Completely interferes”): ○ Work ○ Activity ○ Mood ○ Enjoyment ○ Sleep ○ Walking ○ Relationships

The Memorial Pain Assessment Card

The McGill Pain Questionnaire

The McGill Pain Questionnaire8 is one of oldest and the most extensively used pain scales. The questionnaire consists

The Memorial Pain Assessment Card9 was developed as a rapid multidimensional tool in cancer patients that uses 3 separate visual analog scales to assess pain, pain relief, and mood. This tool includes a set of adjectives for describing pain intensity as well. The major advantage of this tool is that it takes very little time to administer; the results also correlate with other, more time-consuming evaluators of pain and mood. The convenience of this card is that it can be carried easily in the clinician’s pocket, folded, and conveniently presented to the patient, one scale at a time.

Memorial Pain Assessment Card

4

3

MOOD SCALE Worst mood

RELIEF SCALE No relief of pain

Best mood

1

4

PAIN SCALE Least possible pain

Complete relief of pain

MOOD SCALE Moderate Strong

Worst possible pain

Just noticeable No pain Mild

Excruciating

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Weak

Severe

REFERENCES

5. Hicks CL, von Baeyer CL, Spafford P, et al. Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. PAIN. 2001;93:173–183.

1. Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006;15 suppl 1(suppl 1): S17-S24.

6.

2. Boonstra AM, Schiphorst Preuper HR, Reneman M, et al. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain.

Int J Rehabil Res. 2008;31:165–169.

McCaffery M, Pasero C. Pain: Clinical Manual. 2nd ed. St. Louis, Mosby; 1999.

7. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory.

Ann Acad Med Singapore. 1994;23(2):129–138.

8. Melzack, R. The McGill Pain Questionnaire: major properties and scoring methods.

PAIN. 1975;1(3):277–299.

3. Cork RC, Isaac I, Elsharydah A, et al. A comparison of the verbal rating scale and the visual analog scale for pain assessment. Internet J Anesthesiol. 2004;8(1).

9. Fishman B, Pasternak S, Wallenstein SL, et al. The Memorial Pain Assessment Card. A valid instrument for the evaluation of cancer pain. Cancer.

1987 Sep 1;60(5):1151-1158.

4. Clark ME, Gironda RJ, Young RW. Development and validation of the Pain Outcomes Questionnaire-VA. J Rehabil Res Dev. 2003 Sep-Oct;40(5):381–395.

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Need A TuneUp?

PAINWEEK’21 CONFERENCE PREVIEW P.74

short cuts

Laura Meyer-Junco pharmd, bcps, cpe Clinical Assistant Professor, University of Illinois at Chicago College of Pharmacy

“As a clinician with fibromyalgia, I feel uniquely positioned to act as an advocate for fibromyalgia patients…”

GPS Rockford, IL Typical Day Every day is different! My pharmacy students and I participate in hospice interdisciplinary rounds, see patients in the supportive oncology clinic, and work up patients for internal medicine rounds at the hospital. Squeezed in are geriatric and pain management lectures, projects, and responding to questions from hospice nurses. Persona I am a strong proponent of life-long learning and believe that learning and teaching can be both fun and meaningful. I hope to leave the student, patient, or colleague a little brighter and a little lighter in his/her steps. Social Media Habits I like to stay connected and see the careers of former students unfold on LinkedIn. Contribution Bringing clinical pharmacy services in hospice and palliative care to Rockford. My mom suffered from horrible cancer pain and did not have access to palliative care. I made it my goal to insert myself into palliative and hospice services beginning to grow in my hometown. I became a founding member of the palliative care team where my mother received her cancer care and have become the pharmacist member of two hospices and the palliative care team of another large health-system. People I am blushing…but the public figure I admire the most is Dr. Mary Lynn McPherson. She may never know how much she has taught me…not only pain and symptom management, but how to be a courageous pharmacist leader, an absolute female powerhouse, and an effective, enthusiastic, and hilarious teacher! Thank you, Dr. McPherson! Words Everyone should read Dr. McPherson’s books… practice-changing! I also like to live by “collect moments not things.” I believe happiness and fulfillment comes from experiences and learning about and from each other. Popcorn I enjoy streaming dramatic miniseries like Sharp Objects, but when I want to keep it light and hilarious, Schitt’s Creek is my go-to. PAINWeek As clearly displayed on conference signage, “education is the best analgesic.” I believe this to be very, very true. I come to PAINWeek to better myself for my students, teams, and patients, to meet fabulous people with shared interests, and to have fun at the most dynamic and vibrant conference that I have attended.

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short cuts

By Jennifer Hah

md, ms

Don’t just focus on opioids or taking opioids away.

Think of comprehensive solutions to help manage pain long term.

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short cuts

During a trial comparing 2 pain management regimens, researchers examined adult trauma admissions.

patients

patients in their

Researchers examined

pouch lamina propria

hematopoietic cells

from ulcerative colitis patients with (n = 15) and without (n = 11) an ileal pouch–anal anastomosis.

were randomized:

Identified: to multimodal pain regimens (MMPR),

with arthritis

myeloid cells and

are candidates for knee replacement, and younger people are as well.

An implant could last T cells that distinguish inflamed tissues.

to the

Multi-modal Analgesic Strategies in Trauma (MAST) trial.

The MAST MMPR group had lower morphine milligram equivalents (MME) per day (34) vs 48 MME/day, and fewer were prescribed opioids at discharge (62% vs 67%, P=0.029).1

years,

Nonresponsiveness

to anti-integrin biologic therapies in patients with ulcerative colitis was associated with the signature of

myeloid cells in a subset of patients.3

but it doesn’t last indefinitely.

Studies are now focused on the pinpoint accuracy of robotic-assisted knee replacement system. Before surgery, a CT scan is taken of the knee, then uploaded into the Mako system software, and a 3D model of the joint is created.

Healthy bone can be preserved.5

Who has tennis elbow, and why?

ASSESSMENTS—

of patients suffer from acute pain—

commonly lasting <7 days but sometimes ≤30 days— and ibuprofen is a frequently used analgesic.

Rates of prescription and OTC analgesics: 8.5% for daily analgesic use; 13.6% a few times a week; 47% once a week; 76% once a month.

questionnaires

HOUR

were emailed to tennis clubs and databases:

people responded

Low-dose OTC ibuprofen

ambulatory blood pressure monitoring, ECG, blood tests, anthropometric measurements—were performed on patients ≥60 years of age with hypertension and a new prescription of cannabis.

has been used for pain relief for

patients,

(61.7%) had received tennis elbow diagnoses.

How much does age matter?

without any obvious major health issues.2

The average ages: respondents, 38.7 years; diagnosed with tennis elbow, 41.6 years; never diagnosed with tennis elbow, 33.9 years.4

mean age 70.42 ± 5.37 years (53.8% females), completed the study. At 3 months’ follow-up, mean 24-hour systolic and diastolic blood pressures were reduced by 5.0 mmHg and 4.5 mmHg, respectively.6

1. pain.sh/9ya 2. pain.sh/qpu 3. pain.sh/22424 4. pain.sh/e3l 5. pain.sh/9a3 6. pain.sh/jzv

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short cuts

2

Underscore. Recommunicate. Opioids.

Gary W. Jay MD, FAAPM

It’s not “an opioid crisis.” In a way it’s “an illicit drug crisis,” “a heroin crisis,” and “a fentanyl crisis.” ● In the late 1980, early 1990s: insurance companies stopped paying for adjunctive pain care ● No pt, psychotherapy, no biofeedback, no acupuncture, but they were happy to pay for opioids ● Later, pain became the fifth vital sign, and the only tool in the box were opioids ● So, this has a lot to do with where we are.

Very few people talk about insurance companies who still use the cdc guideline as reasons for not approving pain medications, not approving what patients may need

1

Solutions to Problems in the Pain Management Field

3

David M. Glick DC, DAIPM, CPE, FASPE

Myopain Conditions and Treatment

There are problems in the pain management field. What are potential solutions?

James R. Fricton DDS, MS; Ginevra Liptan MD

Patient education

Myofascial pain is the most common pain disorder.

It’s a relatively straightforward condition and everybody can recognize it on themselves if they have the condition. It’s usually characterized by a regional pain such as

● Starts with the way we talk to a patient to provide information about their condition ● Helps patients with expectations ● Explains that “a medication—regardless of what the television commercial says—isn’t meant to make your pain go away 100%, that at the very best it might only take the edge off so you can take care of your kids or go to work” ● Makes a patient part of their treatment and they’re more likely to have a better, more successful outcome

● Low back area ● Neck ● Shoulder ● Jaw ● Head The pain is characterized by trigger points:

Others need education, too:

● Trigger points are localized tender area within a taut band of muscle ● When you feel your muscles, for instance, like in the temples, you can feel a knot ● If you go and up and down that knot, you’ll find a tender area that’s more tender than the other areas

● Providers need to better recognize pain pathologies ● Providers need to know it’s okay to step outside narrow confines of “guidelines” when there’s a justifiable reason ● The people who come up with guidelines/ regulations need to know they may create a barrier to a patient getting necessary care

Treatment?

Other issues:

● Work directly on the tissue ● Help patients learn to relax their own muscles, do their own self-massage and stretching ● Trigger point injections can be very helpful ● Myofascial release therapy works on trying to unlock the knotted areas of tissue ● Manual therapy can be done by a patient stretching alone, or with a therapist’s hands helping with additional stretching or working directly massaging the knotted area, trying to unwind or untie that knotted, tight area of the muscle

● EMRs: what would have been a 15-minute consult now maybe is 8 minutes with the patient and 7 minutes completing an emr ● emrs look the same so it may be tough to pick out relevant information ● We need more time with patients: to learn more about them, get more information relative to their condition in order to make a more patient-centered informed decision about what that particular patient may need at that particular time

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4

5

Courtney M. Kominek PharmD, BCPS, CPE; Abigail T. Brooks pharmd, BCPS

Michael C. Barnes JP, MIEP

Renal Dysfunction and Medications

Wishes for the Future: A Policymaker on the Overdose Crisis

What to keep in mind about medication(s):

Wishes for the Future

● What is its metabolic pathway? ● Does it get metabolized to active metabolites? ● Does it not get metabolized? ● Are those metabolites inactive or active? ● Do they get cleared in the urine or by another route? ● What is the dialyzability of a drug?

● Policymakers will start to understand the overdose crisis in the US is much more complex than they have recognized initially ● They will start to adjust their responses to overdose in a way that reflects science, medicine, and economics ● The US government will look at social determinants of health and diseases of despair that contribute to addiction and overdose, but also diabetes, obesity, and other conditions ● The government will take a demand reduction approach to prevent harmful substance use in the first place: it will more rapidly/efficiently/ compassionately address overdose as well as addiction ● We look at not just the supply of opioid medications, but also the supply of illicit substances on the black market ● We look at not just supply, but also demand, and take into consideration there are reasons why people are using illicit substances or misusing controlled prescription medications

Protein binding also is important: ● Drugs bind to proteins ● If there’s a change in the amount of protein the patient has, that will change the amount of free drug and that can lead to side effects or toxicities ● A highly protein bound won’t be removed by dialysis Certain parameters can help indicate whether a medication is going to be removed by dialysis ● The higher the molecular weight, the less likely it would be removed by dialysis ● If a medication is hydrophilic, it’s more likely to be removed ● Volume of distribution: the greater the volume of distribution, the greater it’s distributed throughout your body, outside of your blood ● With a higher volume of distribution, there’s less likelihood it will be removed by dialysis

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short cuts

with

douglas l.

gourlay

md, msc, frcpc, dfasam

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“…scientific discovery doesn’t begin with a ‘Eureka!’

It usually starts with ‘Isn’t that interesting?’”

Q

What inspired you to do what you do?

I began my career studying basic sciences back in the late 1970s and early 1980s. After graduate school, I made the decision to study medicine, ultimately completing a fellowship in anesthesiology. During that time, my interest in regional anesthesia led me toward pain management in general and ultimately to study pain and chemical dependency.

significant ones were from my undergraduate and graduate studies in chemistry. Professor Stan Walker, a brilliant physical chemist, and Dr. Andrew Booth, the then president of Lakehead University helped me develop an approach to problem solving that began with observation. I learned that scientific discovery doesn’t begin with a “Eureka!” It usually starts with “Isn’t that interesting?” I also learned that you always put your money on the plodder, not the genius with poor work habits!

a

Q

Why did you focus on pain management?

Our understanding of basic pain mechanisms was advancing by leaps and bounds. The other side of the coin was largely unstudied and so I developed a keen interest in asking and trying to answer some of these questions related to the risks of using opioids.

a

Q If you weren’t a healthcare provider, what would you be? a I almost certainly would have been an engineer although I seriously considered becoming a double naught spy for a time!

I think if truth be told, playing a Scottish apothecary surgeon at Old Fort William Historical Park for 5 years gave me a leg up on my public speaking skills.

Q

Who were your mentors?

During my early years of study, I had several key mentors. Without question, the most

a

69

short cuts

“I hope [my greatest achievement] is my commitment to education.”

Q

a

Q

What is your most marked characteristic?

My logical approach to problem solving.

Plans for the future?

It’s time for me and my wife to travel the world for pleasure. I’ve logged over 1 million miles in the air to this date, mostly for business—it’s time to travel for fun!

a

Q. What do you consider your greatest achievement? a I hope it is my commitment to education.

Q

What is your motto?

In the absence of knowing what to do, knowing what not to do is a close second!

a

Q

What is your favorite language? a English, although my skill in that regard is often questionable. But any skill I do have I owe to Professor Walker’s wife, Kathleen. Mrs. “W” was a Brit, trained in library sciences. While she did not have a ruler to knock my knuckles when I deviated from the Queen’s English, she had ways to make it known that simply less than perfect simply would not do!!

Douglas L. Gourlay, MD, MSc, FRCPC, DFASAM, is an anesthesiologist in private practice in Canada.

Q If you had to choose one book, one film, and one piece of music to take into space for an undetermined amount of time, what would they be? a Book: The Hitchhikers Guide to the Galaxy

by Douglas Adams.

Film: 2001: A Space Odyssey by Stanley Kubrick.

Music: Anything from my 1970’s collection! If there is harmony, I’m in!

Q

What would you like your legacy to be?

I hope my legacy will be seen in those students who took the time to ask me questions and, in some cases, listened to my answers!

a

70

click.

A quote from bell hooks, American author, professor, feminist, and social activist

short cuts

By Wendy Caster

Across

1. Rock and rollers Andy and Barry 6. The sailor in the next bunk 14. Bright-eyed and bushy-tailed 15. Describing a boat with five rowers 16. Proof that vaccines work 17. bell hooks quote about pain, part 1 18. Haha in textese 19. Go ___ detail 2 0. Get fewer points 21. Far from outgoing 23. ____ Sam, Sam ____ (both blanks are the same) 25. One of the rolly things on a desk chair 27. bell hooks quote, part 2 31. Type of research done about election competitor (slang) 32. Most cunning 33. “Live ____” (Taco Bell slogan) 36. No longer employed, in brief 37. Santa ____ winds 38. Popular review site 39. Tokyo before 1868 4 0. All together 43. Therefore 44. bell hooks quote, part 3 4 6. Esoteric 5 0. Omega Health Investors or “other health impairment” (abbrev.)

51. “Are we there ___?”

52. Initialism for “male assigned at birth” 53. Benign growths in cortical or deep gray matter that often cause partial seizures in children and young adults (abbrev.)

56. Genre of music known for expressing feelings 5 8. bell hooks quote, last part 6 0. Hindu queens 63. Least easy-going 6 4. Eye-like opening or design 65. Home of China, Japan, and North and South Korea 6 6. Work stations

Down

1. Old Navy and Banana Republic sibling 2. International Labour Organization, in brief 3. Move toward the bar in the old West 4. Verve 5. Unexcitable 6. Shock

7. Bulk 8. Quite clear 9. Raven poet 10. Sedimentary rocks made of clay and lime 11. “She’s ____” (very funny) 12. Ill at ease 13. Landscaper’s tool 17. Mimic 21. Cursed 22. Wished 24. Equine animal 26. Lawyer, in brief 2 8. Signal agreement silently 29. Church council 3 0. The result of combining two waves of different frequencies or, maybe, a letter from Alan Ginsburg or Jack Kerouac 33. “Lord have ____” (quote from Psalm 123:3) 34. Pond buildup

Puzzle solution: painweek.org/crossword.

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35. Baseball or football 38. Progressive rock band or word on a ouija board 4 0. Bed-and-breakfast 41. Teases 42. “___ la la!”

45. Important part of a car’s steering system 4 6. Entertain 47. Bob Marley fan, perhaps 4 8. Bistros 49. Halt 54. Not yet final, at law 55. European Free Trade Association, in brief 57. Cudgel or a relative of pepper spray 59. Cellular messenger 61. Type 62. Sibling, in brief

Celebrating our 15th year, PAINWeek remains the largest US pain conference and the favorite destination for frontline practitioners to enhance their competence in pain management. As always, clinicians can immerse themselves in 5 days of continuing medical education across multiple therapeutic areas, taught by over 70 pain management thought leaders. Join us for a multidisciplinary agenda, inclusive of satellite events, exhibits, and more! Additional credit hours will be available via PAINWeek On Demand, beginning November 2021.

BONUS Tracks!

This year we are presenting a NEW BRAINWeek track on Friday and Saturday focused on headache and selected CNS disorders.

Follow us on: fili

Please note that the first certified-for-credit course begins on Tuesday, September 7, at approximately 7:30a. The last certified-for-credit course concludes on Saturday, September 11, at 3:30p.

!

MON 9.6 6:00p – 7:00p

→ PAINWeek 101 *—Making the Most of Your PAINWeek Experience!

TUES 9.7 The following sessions will be presented from 7:30a – 6:30p. ●

American Society of Interventional Pain Physicians

→ Post-Surgical Neuralgia: Diagnosis and Treatment → Treatment Algorithm for Managing Chronic Back Pain in the Elderly Population → Interventional Options for Refractory Migraine and Cervicogenic Headaches

●

→ Painful Conditions of the Upper Limb: Arm Pain → “Doctor, I Have a Pain Between L4 and L5”: Dealing with False Positives and Google Dx → Updates on Complex Regional Pain Syndrome → Neurogenic Thoracic Pain Syndrome → Osteoarthritic Joint Pain: Advances in Diagnosis and Treatment → 6 Symptoms in Search of a Diagnosis: Fibromyalgia and Headache ●

Behavioral Pain Management

→ Alcohol: Pain Panacea or Problem? → Casting a Wider Net: Using Focused Acceptance & Commitment Therapy in Primary Care → Calming the Storm: Adding PTSD Treatment to Your Pain Practice → What’s Psych Got to do with Perioperative Pain Management? → The Dog Ate My Homework: A Guide to Avoiding Relapse and Maintaining Adherence → All in the Family: Their Role and Impact on Pain Management

Pain Management Coaching

→ Night and Day: The Disabling Power of Sympathy/ The Enabling Power of Empathy → Everything's Coming Up Roses: Case Studies in Pain Management Coaching → Implementing a Pain Coach Education Service in an Academic Medical Center During COVID-19 ●

●

Key Topic

→ Apocalypse Now…or Later?

Chronic Pain After COVID-19 ●

WED 9.8

Chronic and Regional Pain Syndromes

Pharmacotherapy

→ Prime Time or Too Soon?

Pharmacogenetics in Pain Management → See, Be, Deceived…or Relieved?

Evaluating CBD for Pain Management → Taming of the Spew: Managing Opioid-Induced Nausea → Tales of Pain Self-Management: The Who, What, Why, and How!

The following sessions will be presented from 7:30a – 6:30p. ●

Acute Pain Management

→ Acute Care for Patients Admitted to the Hospital with Opioid Use Disorder → An Integrative Pain Management Toolkit Initiative for Emergency Department and Hospital Patients → Acute Post-Operative Pain: Current Practice, Novel & Upcoming Analgesic Options, and Drug Development → Reiki for Relaxation and Pain Relief in the Acute Care Setting ●

Advanced Practice Providers

→ Psychedelics in Pain Management — An Answer in Search of a Question → Chronic Pain in the Year of a Pandemic: Advanced Practice Provider Edition → So, You Checked the PDMP —Now What? → The Collaborative Care Model: The Perioperative Surgical Home → Medical Cannabis: What Every Clinician Needs to Know ●

Key Topics

→ Digital Therapeutics: Technological Advances in Pain Medicine → Who Should Own Back Pain?

An Interventional Pain Physician and a Physical Therapist Debate ●

Medical/Legal

→ Through the Lens of Experts: Meaningful Risk Mitigation and Patient Education → Who’s Looking at You, Doc? A Rational Response to 2021 Perspectives on Opioid Prescribing

*Not Certified for Credit

!!

●

Pain Basics Forum

→ Pain Pathways Made Simple → Chronic Pain Assessment → Clinical Pearls: Unraveling the Secrets of Imaging Studies → Back to the Basics: The Role of Psychology in Pain ●

Keynote Address and Welcome Reception*

THU 9.9 The following sessions will be presented from 7:30a – 6:30p. ●

International Pelvic Pain Society

→ The Lesser of 3 Evils?

Untangling Somatic and Neurologic from Visceral Pain → Fire in the Lake: Raging War Over Endometriosis → When Sitting Hurts: Unraveling Pudendal Neuralgia ●

Medical/Legal

→ The Importance of Being a Prudent Prescriber → From the Ivory Tower: The Data-Driven Strategy CMS, Health Plans, and State Governments Use to Review a Provider’s Clinical Practice

→ The Dark at the Top of the Stairs: Addressing the Escalation of the Opioid Epidemic Due to COVID-19 → Tell Me Why It Hurts ●

Key Topics

→ Vaping in the 21st Century: Is There a Safer Way to Deliver Drugs? → The Fight Has Just Begun: COVID-19, the Opioid Epidemic, and Chronic Pain Treatment

Poster Session and Reception*

FRI 9.10

Special Interest Sessions

→ The Referral Loop: A Guideline for Frontline Clinicians on Electromyography and Nerve Conduction Studies → The Ambient Zone: Sleep Induction Through Music Meditation → The Adenosine Type 3 Receptor as a Novel Target for the Development of Safe and Effective Nonopioid Analgesics ●

●

The following sessions will be presented from 7:30a – 6:30p. ●

●

Neurology

→ A Face in the Crowd: Trigeminal Neuralgia and Atypical Facial Pain → Awkward Conversations: Managing the Difficult Pain Patient → Rhapsody in Black: Differential Dx of Occipital Neuralgia and Cervicogenic Headache → A Feather or a Hammer?

Pain and Movement Disorders ●

Pharmacotherapy

Interventional Pain Management

→ Taking Private Interventional Pain Practices from Good to Great → Surgical Consult: When Pain Management Is Contraindicated → Electrical Tingles: Neuromodulation for the General Practitioner → Diabetic Peripheral Neuropathy: Introducing New Interventional Options → Sacroiliac Joint Dysfunction: Diagnosis, Treatment, and Emerging Therapies ●

Key Topics

→ Urine Drug Testing: Meeting the Test of Medical Necessity Through PatientCentered Care → 2+2 Before: Using New Math to Calculate Opioid Risk

→ NSAID Counterattack: Baby, We’re Back! → On Golden Pond: Geriatric Pain Management → Will the Real Fentanyl Please Stand Up? → 7mm from Hell: Coping with Kidney Stone Pain → Hocus Pocus: What Muscle Relaxants Do…and Don’t Do ●

Special Interest Sessions

→ Bad Breadth: The Role of Bias, Stigma, and Social Determinants in Pain Care → OMG OMT: A Guide to Osteopathic Manipulative Therapy → Health Literacy, Pain Medicine, and COVID-19: Room for Improvement

●

Master Class

→ Back Pain: It’s All About the Diagnosis

*Not Certified for Credit

SWANK!

●

Occupational and Physical Therapy

→ Physical Rehabilitation for Patients with Trauma → OT and Biopsychosocial Pain Treatment: The “Other Therapy” You Never Knew Your Patients Needed → Working the Body: A Whole Health Perspective on Movement and Pain ●

Pharmacotherapy

→ Melt in Your Body, Not in a Needle: A Review of ADF Opioids → Sedated and Elated: Treatment Tactics for Refractory Agitation → A Potpourri of Natural Opioids: Access, Safety, & Regulatory Responsibilities → No Kidding Around: Pediatric Trauma Care ●

Podium Poster Presentations*

Pharmacotherapy

●

→ Fake MUs! A Review of Atypical Opioid Medications → A Garden of Earthly Delights: Evaluating OTC Options for Pain Management → How Low Can You Go? The Lowdown on Low Dose Analgesics ●

BRAINWeek Presents

→ The L-Shaped Room: Challenges and Advances in the Diagnosis and Treatment of Migraine → The Emerging Role of CGRP Inhibitors in the Prevention and Treatment of Migraine → Elevator to the Gallows: Trigeminal Autonomic Cephalalgias → Who’s on First? Neurologic and Psychiatric Management of Migraine ●

●

Veterans Health Administration

→ Evolution, Not Revolution: Opioid Safety in a Brave New World → Be There: Suicide Prevention as Highest Priority → Off Script: Why You Should Write for Behavioral Medicine → If You Build It: The Progress and Pitfalls of Implementing Pain Management Teams

Exhibit Hall Closing Reception*

SAT 9.11 The following sessions will be presented from 7:30a – 3:30p. ●

●

Special Interest Sessions

→ Rebalancing Pain Medicine: Improving Care Through a Wider Lens? → Tiny Habits for Pain Management → The Brain and Neuromodulation in the Management of Osteoarthritis Pain → A Turning Wind: Women, Pain, and Health Equity

American Society of Pain and Neuroscience

→ Panel Discussion: Innovations in Interventional Pain Management → The Role of Regenerative Medicine in Low Back Pain → New Advancements in Spinal Cord Stimulation → Dorsal Root Ganglion and Peripheral Nerve Stimulation: A More Targeted Approach for Nerve Pain → The Future of Minimally Invasive Spine Treatments: Moving from Open to Less Invasive Approaches ●

Key Topic

→ Brave New World: Guidelines and Treatment Strategies for Sickle Cell Disease

●

BRAINWeek Presents

→ Up the Down Staircase: Addressing Adherence in Relapsing Bipolar Disorder → Diagnosing on the Spectrum: Alzheimer’s Disease and Lewy Body Dementia → I Can’t Hear You: Association of Subclinical Hearing Loss with Cognitive Performance → Examining Cannabinoids in the Epilepsy Treatment Spectrum

*Not Certified for Credit

REGISTRATION FEES

JUNE 1 ������������ $699 SEPT 1 �������������$799

REGiSTER NOW! @www.painweek.org OR Call (877) 724–6933

Accreditation 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 34.0 AMA PRA Category 1 Credits™.

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

Applications for certification of physical therapy ACEND 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.

RECOMMEND WITH CONFIDENCE

The American College of Physicians and the American Academy of Family Physicians, have made a strong recommendation1:

Use topical NSAIDs first for acute, non-low back musculoskeletal pain.

A formulation they recommend can be found in these Salonpas Pain Relievers.

©2020 Hisamitsu America, Inc. Use as directed.

1 Amir Qaseem et al., Nonpharmacologic and Pharmacologic Management of Acute Pain From Non–Low Back, Musculoskeletal Injuries in Adults: A Clinical Guideline From the American College of Physicians and American Academy of Family Physicians, Annals of Internal Medicine (2020), available at https://www.acpjournals.org/ doi/10.7326/M19-3602.