Treating the Full Spectrum of Narcolepsy: Improving Nighttime Symptoms to Enhance Daytime Quality of Life

Transcription

1 SYLLABUS AND COURSE GUIDE Session I: Thursday, October 13, 2016 Session II: Wednesday, October 19, 2016 Treating the Full Spectrum of Narcolepsy: Improving Nighttime Symptoms to Enhance Daytime Quality of Life Live Q&A with Dr. Bogan(Session I & II) MODORATOR: Thomas Roth, PhD FACULTY: Richard K. Bogan, MD, FCCP, FAASM, and Todd J. Swick, MD WC WC Take advantage of our LIVE Q&A segment during this webcast! Call in to listen and/or ask the faculty a question: Fax in your question or comment: your question or comment: questions@cmeoutfitters.com All other questions: Call CME Outfitters at 877.CME.PROS A Free, 60 minute CME/CNE/CPE WEBCAST Thursday, October 13, 2016, at 12:00 pm ET (Session I) OR Wednesday, October 19, 2016, at 12:00 pm ET (Session II) (free account activation and log-in required) Provided by The recipient may make a request to the sender not to send any future faxes and failure to comply with the request within 30 days is unlawful. To opt out from future faxes go to enter PIN# 11105, or call , or fax back to

2 Statement of Need INFORMATION FOR PARTICIPANTS Patients with narcolepsy often face a long journey on their path to diagnosis and effective treatment. Combating the negative impact of narcolepsy on the lives of those affected requires that both the general public and the medical community increase their awareness of the symptoms of narcolepsy, in particular, the most common presenting symptoms: cataplexy and excessive daytime sleepiness. Improved recognition of both symptoms and objective measures of narcolepsy can shorten the burdensome lag from symptom onset to effective treatment and improve the lives of people with this life-altering central disorder of hypersomnolence. Although a cure for narcolepsy is not available, effective treatments are currently available and more are on the horizon. In this neurosciencecme Expert Connection Module, faculty will discuss screening strategies for patients with possible narcolepsy, applying AASM quality measures for diagnosis of narcolepsy, and prescribing evidence-based treatment. Learning Objectives At the end of this CE activity, participants should be able to: Prescribe evidence-based treatment for all patients with narcolepsy within one month of diagnosing the narcolepsy. The following learning objectives pertain only to those requesting CNE credit: Define evidence-based treatment for all patients with narcolepsy that can be used within one month of diagnosing the narcolepsy. Target Audience Primary care physicians, physician assistants, nurse practitioners, nurses, pharmacists, and other healthcare providers who manage patients with narcolepsy. Financial Support Supported by an educational grant from Jazz Pharmaceuticals, Inc. CREDIT INFORMATION CME Credit CME Outfitters, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. CME Outfitters, LLC, designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity. CNE Credit Provider approved by the California Board of Registered Nursing, Provider Number CEP 15510, for 1 contact hour. Note to Nurse Practitioners and Clinical Nurse Specialists: the content of this activity pertains to pharmacology. Earn up to 1 contact hour of pharmacotherapeutic contact hours. CPE Credit CME Outfitters, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 1 contact hour (0.10 CEU) Universal Activity Number Session I: Universal Activity Number Session II: Type: knowledge-based L01-P (live program) H01-P (recorded program) L01-P (live program) H01-P (recorded program) 2

3 CREDIT REQUIREMENTS Successful completion of this CE activity includes participating in the activity, reviewing the course materials, and following the instructions below within 30 days of completion of the activity: To complete your credit request form, activity evaluation, and post-test online, and print your certificate or statement of credit immediately (75% pass rate required), please visit cmeoutfitters.com/tst20160 (for session I) & cmeoutfitters.com/tst20161 (for session II) and click on the Testing/Certification link under the Activities tab (requires free account activation). This website supports all browsers except Internet Explorer for Mac. For complete technical requirements and privacy policy, visit There is no fee for participation in this activity. The estimated time for completion is 60 minutes. Questions? Please call 877.CME.PROS. FACULTY BIOS & DISCLOSURES Thomas Roth, PhD (Moderator) Dr. Roth has been the Director of the Sleep Disorders and Research Center at the Henry Ford Hospital in Detroit, Michigan, USA, since Dr Roth is also a Professor in the Department of Psychiatry at Wayne State University, School of Medicine in Detroit, Michigan, and serves as a Clinical Professor in the Department of Psychiatry at the University of Michigan, College of Medicine in Ann Arbor. After serving as president of the Sleep Research Society, and the founding president of the National Sleep Foundation (NSF), Dr Roth became chairman of the National Center on Sleep Disorders Research advisory board. In addition, he was a member of the board of directors of the Associated Professional Sleep Societies (APSS), chaired the Association s Scientific Program Committee and the governing board of the World Federation of Sleep Research Societies. Dr. Roth was instrumental in the formation of the Association of Sleep Disorders Center (ASDC) and served as the organisations second president. He is also the former Chairman of the World Health Organizations worldwide project on sleep and health. In addition to authoring and co-authoring numerous articles, Dr. Roth serves as past editor-in-chief of the journal Sleep. He currently sits on the editorial boards of Sleep Reviews, Stress Medicine, and Advances in Therapy and Human Psychopharmacology. In 2002, Dr. Roth received the NSFs Lifetime Achievement Award for his accomplishments and contributions to sleep science, sleep medicine and public health. He received a Distinguished Research Award from the Sleep Research Society as well as the Nathanial Kleitman Award from the Academy of Sleep Medicine. Dr. Roths contributions to the sleep field are expansive, ranging from prolific research productivity and scholarship to multiple national leadership positions, as well as the mentoring of many students and colleagues. Dr. Roth received his doctorate in 1970 from the University of Cincinnati and has since studied sleep homeostatic processes, sleep loss, sleep fragmentation, sleep pathologies and the effects of pharmacologic agents on sleep/wake function. Dr. Roth has published over 407 manuscripts, 15 edited volumes, 219 chapters, and 594 abstracts. Richard K. Bogan, MD, FCCP, FAASM Dr. Bogan is the Medical Director of SleepMed of South Carolina in addition to serving as Chief Medical Officer of SleepMed, Inc., the largest sleep diagnostic company in the United States. He is also Associate Clinical Professor at the University of South Carolina School of Medicine and Associate Clinical Professor at the Medical University of South Carolina in Charleston, S.C. Dr. Bogan received his bachelors degree in chemistry from Wofford College and his MD degree from the Medical University of South Carolina in Charleston. He served his internship and residency, as well as Chief Medical Resident, at the University of Alabama Hospital and Clinics in Birmingham. Thereafter, he completed a fellowship and assistant professorship in the Pulmonary Division of the Department of Medicine at the University of Alabama School of Medicine. He has been certified by the American boards of Sleep Medicine, Internal Medicine and Pulmonary Diseases. Dr. Bogan has served as principal investigator on numerous clinical trials in the past and continues to do so now. He has a variety of publications and research interests that focus on topics such as narcolepsy, insomnia, sleep apnea, shift work sleep disorder, restless legs syndrome/periodic limb movement disorder, chronic fatigue/fibromyalgia and circadian rhythm abnormality. 3

4 Todd J. Swick, MD Dr. Swick is board certified in neurology and sleep medicine (American Board of Sleep Medicine and the American Board of Psychiatry and Neurology with a subspecialty in Sleep Medicine). He is Assistant Clinical Professor of Neurology at The University of Texas School of Medicine-Houston and is Senior Medical Director of Neurology and Sleep Medical Consultants of Houston. He the Medical Director of The North Cypress Medical Center Sleep Disorders Center and Apnix Sleep Diagnostic Centers in Houston, Texas. He has been practicing in Houston, Texas for the past 34 years and has spent the last fifteen years doing sleep medicine on an exclusive basis. He has close to 4000 patients in his practice and one of the largest Narcolepsy practices in Texas. He has published numerous papers involving neurologic sleep physiology, narcolepsy, chronobiology, sleep and wake disorders associated with Parkinson s disease and the interaction between pain and sleep in chronic pain syndromes. Dr. Swick has been involved in over 90 FDA approved Clinical Research trials, most recently for, Insomnia, Narcolepsy, Non 24 Hour Sleep Disorder in totally blind individuals, Jet Lag, Parkinson s disease, Fibromyalgia, Epilepsy, and Alzheimer s disease. In Oct 2014, The National Narcolepsy Network, in Denver, CO, awarded the 2014 Robert Clark, MD, Clinician of The Year Award, to Dr. Swick. He serves as a national speaker on Sleep Medicine & Neurology for national and international pharmaceutical companies such as Merck, Jazz Pharmaceuticals, XenoPort Pharmaceuticals, UCB Pharma and Vanda Pharmaceuticals. Has has been asked to help develop and start the first private Sleep Medicine Center in The People s Republic of China, Beijing. Disclosure of Relevant Financial Relationships with Commercial Interests It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CE activity. CME Outfitters, LLC, has evaluated, identified, and attempted to resolve any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations. Dr. Roth has disclosed that he serves on the speakers bureau for Merck. He is a consultant for Cereve; Flamel Technologies SA; Jazz Pharmaceuticals, Inc.; Merck & Co., Inc.; Novartis Pharmaceuticals Corporation; Proctor & Gamble; Pfizer Inc.; SEQ Dr. Bogan has disclosed that he receives research support from Actelion Pharmaceuticals US, Inc.; Apenex Medical, Inc.; ApniCure, Inc.; Balance; Beckman Coulter, Inc.; Bioavivus Inc.; Boehringer Ingelheim; Eisai Inc.; Fisher Paykel; GlaxoSmithKline; Jazz Pharmaceuticals, Inc.; Johnson & Johnson; Merck & Co., Inc.; Novo Nordisk; Philips; Pfizer Inc.; ResMed;; Sensory Medical, Inc.; Vanda Pharmaceuticals; XenoPort, Inc. He serves on the speakers bureau for Cephalon, Inc.; Jazz Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; XenoPort, Inc. He is a consultant for Aerial BioPharma LLC; Jazz Pharmaceuticals, Inc.; Teva Pharmaceuticals USA. He is the chief medical officer, member of the board of directors, and employee of SleepMed, Inc. His other financial income sources or equity include the board of directors for First Community Corporation, SC and National Sleep Foundation. Dr. Swick has disclosed that he receives research support from Jazz Pharmaceuticals, Inc. He serves on the speakers bureau for Jazz Pharmaceuticals, Inc. He is a consultant for Jazz Pharmaceuticals, Inc. Tony Graham, MD (content/peer reviewer) has no disclosures to report. Kimberley Murray, RN, MS (peer reviewer) has no disclosures to report. Catherine Murray (planning committee) has no disclosures to report. Sharon Tordoff, CHCP (planning committee) has no disclosures to report. Jan Perez, CHCP (planning committee) has no disclosures to report Disclosures were obtained from the CME Outfitters, LLC staff: No disclosures to report. 4

5 Unlabeled Use Disclosure Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices. CME Outfitters, LLC, the faculty, and Jazz Pharmaceuticals Inc. do not endorse the use of any product outside of the FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed during this activity without evaluation of their patient for contraindications or dangers of use. Activity Slides The slides that are presented in this activity are available for download and printout at the neurosciencecme website: Activity slides may also be obtained via fax or by calling 877.CME.PROS. 5

6 The Journey to Diagnosis and Optimal Treatment of Narcolepsy: Land of Missed Opportunities CME Outfitters, LLC, gratefully acknowledges an educational grant from Jazz Pharmaceuticals, Inc. in support of this CME/CE activity. Treating the Full Spectrum of Narcolepsy: Improving Nighttime Symptoms to Enhance Daytime Quality of Life Thomas Roth, PhD (Moderator) Henry Ford Hospital Detroit, MI 6

7 Richard K. Bogan,MD, FCCP, FAASM University of South Carolina School of Medicine Columbia, SC Medical University of South Carolina Charleston, SC Todd J. Swick, MD University of Texas Medical School Health Sciences Center at Houston Memorial and Katy Sleep Centers Houston, TX The Sleep Center at North Cypress Medical Center Cypress, TX Treating the Full Spectrum of Narcolepsy: Improving Nighttime Symptoms to Enhance Daytime Quality of Life Learning Objective Prescribe evidence-based treatment for all patients with narcolepsy within 1 month of diagnosing the narcolepsy. 7

8 AASM Quality Measures: Outcome Measures Reduce EDS Improve accuracy of diagnosis Reduce adverse events Treatment Initiation Following Initial Diagnosis Process Measure #2: Proportion of patients with a new diagnosis of narcolepsy that were advised to pursue pharmacologic and/or behavioral treatment for symptoms within 1 month of date of MSLT or diagnosis by CSF hypocretin Patient Survey Patient Survey Questions Five questions posed to people with narcolepsy who are active in social media The panel represents responses from people with narcolepsy and their caregivers How long do members of your community typically wait from the time of their sleep testing until they receive a prescription for effective treatment of their narcolepsy? Would they consider this to be a reasonable length of time? 8

9 Patient Survey Responses Effective treatment takes years and years sometimes. Doctors seem to start with old school treatments or inexpensive treatments. Patients end up going back to the doctor over and over again to find a better treatment. In the end, it takes a very long time, at least a year before their health starts improving. I finally received a correct diagnosis of narcolepsy after a second sleep study two years following one that diagnosed me with sleep apnea. I waited an additional two years without adequate treatment before I found a sleep specialist on my own and finally began receiving the care that has brought me to a place of functioning again. I do not consider two to four years a reasonable length of time to get appropriate medication. Treatment of Excessive Daytime Sleepiness Treatments Treatments Wake-promoting agents Modafinil (Standard, Level 1) Armodafinil (Standard, Level 4) Psychostimulants (Guideline, Level 2) Amphetamine Methamphetamine Dextroamphetamine Methylphenidate 9

10 Treatments Sodium oxybate (SXB) Cataplexy, daytime sleepiness, and disrupted nighttime sleep (Standard, Level 1) Hypnagogic hallucinations and sleep paralysis (Option, Level 3) Time to Response for Patients Treated With SXB Eighty-six patients who continued into GHB-3 after participating in GHB % were EDS responders 90.7% were cataplexy responders Onset of therapeutic response in 50% of all patients was within 2 months Treatments Scheduled naps (Guideline, Level 2) Daytime sleepiness Treatment of Cataplexy 10

11 Treatments for Cataplexy Investigational Treatments Sodium oxybate only FDA approved agent Tricyclic antidepressants* SSRIs* Venlafaxine* Cataplexy (Guideline, Level 2) There are at least 5 other molecules being investigated Children and adolescents (age less than 18 years) Sodium oxybate (narcolepsy type 1) Regular Follow-up Following and Monitoring Patients Standard, Level 1 Monitor response to treatment Respond to potential side effects of medications Enhance the patient s adaptation to the disorder 11

12 Reduce Adverse Events: Process Treatment follow-up Documented medication counseling Documented safety measure counseling Most Common Adverse Effects of FDA-approved Drugs for Narcolepsy Drug Category of Drug Adverse Effects Amphetamine Amphetamine/Dextro Amphetamine Armodafinil Dextroamphetamine Methylphenidate Modafinil Sodium Oxybate Psychostimulant Psychostimulant Wakefulness- Promoting Agent Psychostimulant Psychostimulant Wakefulness- Promoting Agent Cardiovascular, CNS, GI, Allergic, GU* Headache: 26% Insomnia: 12%-27% Loss of Appetite: 22%-36% Headache: 17% Nausea: 7% Dizziness: 5% Appetite Loss: 21%-22% Insomnia: 16%-20% Abdominal Pain: 11%-15% Headache* Hypertension Nausea Headache: 34% Nausea: 11% Nervousness: 7% Nausea: 8%-20% Dizziness: 9%-15% Vomiting: 2%-11% Documented Safety Measure Counseling Process Measure #7: Proportion of patients diagnosed with narcolepsy that have documentation that counseling was received regarding age-appropriate safety measures before or at the time of diagnosis. Safety Measure Counseling Household chores Safety in the work environment Operation of hazardous equipment Career limitations Shift work On-call schedules Transportation industry 12

13 Clinical Connections Effective treatment should be instituted within 30 days of the diagnosis of narcolepsy being made. Primary care clinicians and sleep physicians must work closely together to ensure that response to treatment is monitored and adverse effects of treatment and medication interactions are minimized. Sleep physicians should communicate clearly with their patients primary care team to ensure the optimum outcome with the treatment of narcolepsy. Patients with narcolepsy frequently have comorbid conditions that must be addressed through an individualized treatment plan. Questions? Call toll-free: Fax: Twitter: #SleepCME To receive CME/CE credits for this activity, participants must complete the post-test and evaluation online. Click the "Apply for Credit" link found under the presentation slide window to complete the process and print your certificate. 13

14 This continuing education activity is provided by WC WC Attendance Form for Groups Please complete and FAX to Activity Title and Faculty: Treating the Full Spectrum of Narcolepsy: Improving Nighttime Symptoms to Enhance Daytime Quality of Life: Live Q&A with Dr. Bogan (Session I & II) with Richard K. Bogan, MD, FCCP, FAASM, Todd J. Swick, MD, and Thomas Roth, PhD (moderator) Site/Institution Name: Office-based Hospital Clinic Managed Care Small Group Practice (less than 5) Practice Setting: Large Group Practice (more than 5) Other: Address: City: State: ZIP: Site Coordinator: Phone: Fax: LIVE webcast LIVE phone Completion Date: We participated in a: Attendee Name (please print) (please print) Please Circle Discipline Please FAX completed form to and use additional sheets as necessary. Questions? Call 877.CME.PROS. Thank you for participating in this continuing education activity! The recipient may make a request to the sender not to send any future faxes and failure to comply with the request within 30 days is unlawful. To opt out from future faxes go to enter PIN# 11105, or call , or fax back to