VOLUME 33 · ISSUE 7 · July 2019
AAN STUDY EXAMINES RISE IN OUT-OF-POCKET COST FOR NEUROLOGY MEDICATIONS The amount of money people pay out-ofpocket for medications to treat neurologic conditions like multiple sclerosis, dementia, and Parkinson’s disease has Callaghan Johnson risen sharply over 12 years, with the most dramatic increase for multiple sclerosis (MS) medications, according to a study published in the May 1, 2019, online issue of Neurology® at Neurology.org. The study, funded by the AAN, found that average out-of-pocket costs for people taking MS drugs were 20 times higher in 2016 than they were in 2004. “Since previous studies have shown that high costs can create burdens such as medical debt, skipping food or other essentials or even not taking drugs as often as necessary, we wanted to see how these costs affect people with neurologic disorders, which can be complicated, chronic conditions,” said study author Brian C. Callaghan, MD, MS, FAAN, of the University of Michigan in Ann Arbor. Continued on page 6
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Fall Conference Registration Open, Get Best Rates By August 15 Registration is now open for the 2019 Fall Conference at AAN.com/view/19FC. Secure your spot by August 15 for the best savings on the hottest topics in the world of neurology, real-world issues in practice management, innovative science, valuable end-of-year CME, and the opportunity to attend a special pre-conference for advanced practice providers on Thursday, October 17. Continued on page 14
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Axon Registry Quality Measures Spotlight: Falls
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Applications Open for 2020 Research Program Opportunities The Academy knows that making a profound difference in the lives of researchers ultimately makes a profound difference in the lives of patients with brain disease. To exemplify its commitment to promoting neurology and neuroscience research training—across all career levels and discovery stage—the Academy is offering 20 Research Program opportunities in 2020. Visit AAN.com/view/ResearchProgram for more information and to apply for the following opportunities by the October 1, 2019, deadline. Each award will have one recipient unless otherwise indicated.
Understanding How You Get Paid: Part 2
Continued on page 18
10 2019–2021 Committee, Subcommittee, and Work Group Chairs
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In Multiple
Sclerosis —
GREY MATTERS, TOO
Pharma Ad
Learn more about Multiple Sclerosis at MSBrainPreservation.com/art © 2019 Celgene Corporation All rights reserved. 04/19 US-CLG-19-0572
AANnews · July 2019
CONTENTS
News Briefs
Cover
Conferences & Community
AAN Study Examines Rise in Out-of-pocket Cost for Neurology Medications
2019–2021 Committee, Subcommittee, and Work Group Chairs · · · · · · · 10
Fall Conference Registration Open, Get Best Rates By August 15
Griggs Receives 2019 Leading in Excellence Through Mentorship Award · · · · · · · · 11
Applications Open for 2020 Research Program Opportunities
Staff Creativity, AAN Values Strike a Chord · · · · · · · · · · · 11
President’s Column The AAN Is Here to Meet Your Continuing Education Needs · · · · · · · · · 4 Tools & Resources Axon Registry Quality Measures Spotlight: Falls · · · · 5 Incorporating Quality Improvement and Safety into Your Daily Work · · · · · · · · 7 Understanding How You Get Paid: Part Two · · · · · · · · 8
Industry Roundtable Convenes to Learn, Recognize, and Celebrate at the 2019 Annual Meeting · · · · 15 Education & Research UCNS Moves to Virtual Proctoring for Initial Certification Examinations · · · · · · · · · · · 17 Careers · · · · · · · · · · · · · · · 20 Dates & Deadlines · · · · · · · · 21
Policy & Guidelines Summit with Payers Provides Exchange of Concerns, Collaboration · · · · · · · · · · · 9
The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. Contact Information
For advertising rates, contact:
American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415
Eileen R. Henry Wolters Kluwer Health | Medical Research Lippincott, Williams & Wilkins
Phone: (800) 879-1960 (toll free) (612) 928-6000 (international) Email:
memberservices@aan.com
Website: AAN.com
Phone: (732) 778-2261 Email: Eileen.Henry@wolterskluwer.com
The 2019 Annual Meeting in Philadelphia established a new record of 15,150 attendees. Additionally, more than 3,000 Philadelphia area patients, caregivers, students, and others attended the free Brain Health Fair during the meeting.
New Sports Concussion Conference Record A record number of abstracts were submitted for the Sports Concussion Conference that will be held in Indianapolis July 26 to 28. The conference, which includes a keynote address on the science of concussion by Paul Pasquina, MD, Colonel, US Army (ret), Department of Defense, drew more than 90 abstract submissions. Other highlights include a report on the Centers for Disease Control and Prevention’s role in sports concussion prevention and select programming in conjunction with the NCAA, including a Saturday night reception at the NCAA Hall of Champions.
Correction
Capitol Hill Report · · · · · · · · · 9
The Vision of the AAN is to be indispensable to our members.
Record-breaking Annual Meeting
The June issue of AANnews misstated the 2019 operating budget. The operating budget has increased from $11M in 1999 to $61M in 2019.
AAN Chief Executive Officer: Catherine M. Rydell, CAE Editor-in-Chief: John D. Hixson, MD Managing Editor: Angela M. Babb, MS, CAE, APR Editor: Tim Streeter Writers: Ryan Knoke and Sarah Parsons Designer: Siu Lee Email: aannews@aan.com
AANnews is published monthly by the American Academy of Neurology for its 36,000 members worldwide. Access this magazine and other AAN publications online at AAN.com. The American Academy of Neurology ’ s registered trademarks and service marks are registered in the United States and various other countries around the world. “American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.
President’s Column
The AAN Is Here to Meet Your Continuing Education Needs A primary reason why the AAN was founded was to provide for the continuing education needs of neurologists. I hope that those of you who were able to join us at the recent Annual Meeting were able to fulfill many of those needs with the more than 250 education courses available from expert peers on a wide variety of topics. And those are just our traditional courses! The meeting offered a plethora of education opportunities in the experiential learning areas, scientific sessions, plenary sessions, and more.
podcast, which offers up to 24 free self-assessment CME credits per year, have surpassed 19,000 CME credits awarded,, and a new software platform allows searchability in ways we haven’t had in the past. The Neurology podcast regularly features content from Neurology, Neurology ® Clinical Practice, Neurology ® Genetics, and Neurology ® Neuroimmunology & Stevens Neuroinflammation. Last year, we added Continuum® Audio to Continuum®, our official CME journal, providing subscribers with an audio learning option to complement Continuum’s comprehensive review articles. This enhanced But for those of you who missed the meeting—or who subscription, which provides the opportunity to earn hundreds attended but still seek to learn more—you have ample of hours of self-assessment CME per year, is generously chances, beginning with the Annual Meeting On Demand. This discounted for members at $349 a year. is a member-discounted, CME-accredited digital library of presentations from the Philadelphia meeting that provides up I’m proud that my great state of Indiana will again host to 242.75 hours of valuable credits. All of the Annual Meeting the Sports Concussion Conference from July 26 to 28 in Indianapolis. The AAN created this conference five years ago to On Demand programming is available online to provide meet the needs of neurologists and sports professionals such you with convenient access to more than 500 hours of live as coaches and athletic directors who wanted to learn more presentations, including syllabi for more than 200 programs. about this form of brain injury. Convenience is also at the heart of our new Online Learning As the AAN has welcomed new members from the neurology Center, which uses a learning management system to help you care team, such as APPs and business administrators, we’ve choose exactly what you need for CME topics. There you can broadened our education opportunities to benefit them. The find our new NeuroBytes, a series of free, short educational Academy has been providing a practice managers’ track at the videos the Academy introduced in February with “Fundamental Fall Conference. And this coming October 17, we’re excited to Concepts of Alzheimer’s Risk Reduction.” Each month, you offer a new one-day pre-conference for APPs prior to the Fall can find a couple of new three- to five-minute videos on topics Conference. I plan on attending and I look forward to meeting ranging from MS and epilepsy to acute vestibular syndrome many of you and learning more about the challenges you face and ischemic stroke and more. Grab a cup of coffee or tea and and how the AAN can help you. enjoy these knowledge nuggets! Also, in the Online Learning Center you can find the latest edition of NeuroSAE®, the self-assessment exam that measures what you know and where you can enhance your knowledge, and NeuroLearnSM, which keeps you current on clinical and practice topics. These all are free with your AAN membership, and I encourage you to take advantage of them if you haven’t yet done so.
How do you keep tabs on all the AAN conferences, courses, and journal CME you acquire? The Academy has your education accomplishments covered with NeuroTracker, another free member benefit where you can easily access your past courses and credits earned. With your permission, NeuroTracker feeds your info over to the ABPN on a monthly basis to assist with its certification tracking.
As a member, you get exclusive discounts on a host of other education products, such as practice management webinars, the Neurology Board Prep Course, the Neurology MOC Prep Course, and the aforementioned Annual Meeting On Demand.
Most of my readers have accomplished the hardest part of our education—learning how to become a neurologist. But it’s our professional responsibility to continue learning how to become the best neurologist. And that’s why the AAN is here to help.
Our publications are sources of education, of course, beginning with Neurology ®, where you can earn CME credits weekly by reading two articles and taking a quick test, providing the opportunity for members to earn 72 free self-assessment CME credits per year. Downloads of our insightful Neurology
And to those medical students reading this, rest assured that when you join our ranks the AAN will be here to help meet your continuing education needs so you, too, can be the best neurologist you can be.
CONTINUING EDUCATION James C. Stevens, MD, FAAN President, AAN jstevens@aan.com @JimStevensMD on Twitter
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AANnews • July 2019
Tools & Resources
Axon Registry Quality Measures Spotlight: Falls Why is measuring falls important? Patients with neurologic conditions are often at a higher risk of falling due to motor impairments from their disease. Falling, particularly those age 65 years and older, is a common reason for hospitalization and high medical bills as a result. Talking with your patients about falls and how to prevent them is crucial for quality patient care.
Why does Axon Registry have so many falls measures? The Axon Registry ® currently has six different quality measures related to falls. Each of these measures have different target populations and goals. Some of the measures are aimed at screening or preventing falls. Other measures are geared toward creating a plan to minimize future falls. An outcome measure also is available to monitor the number of falls over time. Below is a list of falls measures in the Axon Registry. A list of all falls measures can be found on AAN.com /view/AxonQualityMeasures.
Axon 45: Falls outcome The purpose of this measure is to record the number of falls a patient reports.
Axon 53: Falls plan of care The purpose of this measure is to ensure the safety of patients who have reported a fall by providing them with a plan for care to prevent falling. A follow-up article in the August AANnews® will focus on the documentation for each of the falls measures. Visit AAN.com/view/Axon to learn more about how the Axon Registry—an exclusive benefit to AAN US-based members— can help you enhance the quality of care you provide your patients and reduce the burden of maintaining certification.
Axon 07.1: Falls screening The purpose of this measure is to ask patients with neurologic conditions about falls annually and counsel those with a history of falls on prevention.
Axon 16A: Falls—Screening for future risk The purpose of this measure is to ensure patients 65 and older are screened for fall risk annually.
Axon 16B: Falls—Risk assessment The purpose of this measure is to ensure patients 65 and older with a history of falls have a risk assessment completed annually.
Axon 16C: Falls—Plan of care The purpose of this measure is to ensure patients 65 and older at risk of falls have a plan of care created.
Neurology ® Podcasts:
20 Minutes Pack a Punch! Download the latest podcast at Neurology.org/podcast.
AANnews • July 2019 5
Tools & Resources
AAN Study Examines Rise in Out-of-pocket Cost for Neurology Medications OUT-OF-POCKET continued from cover COSTS IMPACT PATIENTS Key findings of the study include: MS drugs showed the steepest out-ofpocket monthly increase of any neurologic drugs and are increasing exponentially. In 2004, average out-of-pocket: $15 a month In 2016, average out-of-pocket: $309 a month
Costs for people in high-deductible health plans were twice as high for monthly out-of-pocket expense compared to those not in high-deductible plans. With high-deductible plan: $661 a month With non-high-deductible plan: $246 a month
Out-of-pocket medication costs were examined for more than 912,000 people privately insured who took at least one neurologic medication for MS, peripheral neuropathy, epilepsy, dementia, or Parkinson’s disease. Researchers investigated the top five most commonly prescribed medications for each condition as well as any other known high-cost drugs. In a Q&A with AANnews®, Nicholas E. Johnson, MD, FAAN, chair of the AAN’s Advocacy Committee, shared how the AAN has responded to this issue from an advocacy standpoint.
WHO NEEDS MEDICATION?
ONE IN SIX
WHAT DOES THIS MEAN FOR PATIENTS? A recent study* shows since 2001, monthly average out-of-pocket costs for MS medications
INCREASED BY 1,637%
people live with a neurologic disease or disorder
Annual cost of treating neurologic disorders in the US is more than
$500 BILLION ONE IN FOUR
*Callaghan, B. C., Reynolds, E., Banerjee, M., Kerber, K. A., Skolarus, L.E., Magliocco, B., Esper, G. J., & Burke, J.B. (2019). Out-of-pocket costs are on the rise for commonly prescribed neurologic medications. Neurology, https://doi.org/10.1212/WNL.0000000000007564
2004
Average annual cost of MS medications was equal to the price of a new car
2016
Americans can’t afford their medications
Average annual cost of MS medications was equivalent to the price of 3 new cars
Nearly
1 million
adults are living with multiple sclerosis (MS) in the US
AVERAGE PATIENT OUT-OF-POCKET COST FOR MS MEDICATION
2004= $15/month 2016= $309/month cost skyrocketed
more than 20x
In 2016,
MS patients in a
From 2014–2016, patients faced a larger out-of-pocket drug cost than before, especially for MS patients
high-deductible health plan
$661/month
MS patients in a What is the AAN doing to address the traditional health plan high cost of neurologic medications? $246/month What is the Advocacy Committee’s role in these efforts? ©2019 American Academy of Neurology AAN.com “The AAN recognizes that the price of drugs Does the study finding strengthen our “asks” for to treat neurological diseases has risen Congress and federal agencies? exponentially. Our concern is that patients with neurological “It does. This is a high-profile issue in Congress and federal disease are able to access many of these new and exciting agencies, but we have been relying on anecdotal stories therapies. The AAN has worked to increase transparency in the from patients. Other literature on this issue is in oncology or drug pricing space, so that we can identify where in the drug rheumatology, and we look forward to being able to speak distribution system these price increases occur. We have also directly on this issue with data in neurological diseases.” supported efforts to allow Medicare to negotiate the price of therapies. The AAN Advocacy Committee has worked to support What’s next on the horizon? these policies on Capitol Hill and across the Department of “We will continue to work on increasing access to therapies Health and Human Services.” for patients with neurological disease. We will also work on Did the study findings surprise you? educating neurologists to evaluate the financial toxicity of the therapies they prescribe. Finally, we will begin to evaluate the “The data confirms our suspicions that many patients with impact of new ultra-high-priced therapies for rare neurological neurological disease are directly impacted by the increasing diseases on both health system and out-of-pocket costs.” price of drugs. Efforts by insurers to move many of these highpriced therapies from pharmacy benefits to medical benefits have increased over the past few years, and with that patients have increasing financial toxicity from these therapies.”
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AANnews • July 2019
Tools & Resources
Incorporating Quality Improvement and Safety into Your Daily Work The AAN started the Patient Safety Awards in 2012 to recognize individuals and teams for furthering the patient safety field. The Quality Award was added in 2014 to recognize individuals and teams who implemented and successfully advanced quality improvement in practice. In 2015, the awards merged and each year four Safety and Quality Award recipients have been recognized for their achievements advancing patient safety, driving quality improvement, or improving patient outcomes. created with the EMR that The 2019 Safety and Quality included medication reconciliation Award winners were celebrated with dosing time, list of for unique projects on limiting contraindicated medications for unplanned ICU readmissions, patients, nursing alerts for medication errors, bleeding medication administration, risk after EMG, and stroke safety-related orders, and rehab education. Each of these projects Coughlin Kumar Larson consultation. After the admission used the Plan-Do-Study-Act order set was implemented, they (PDSA) quality improvement found zero errors in medication administration in 80 percent methodology to create a change concept, implement the of patients. In the other 20 percent of patients, there were four changed practice, observe the results, and act on the results. medication misadministrations. A Parkinson’s disease admission The two projects below depict examples of how to drive change order set is a feasible way to prevent medication errors. in practice using simple but effective tools. To limit unplanned ICU readmissions at the University of Pennsylvania, project leaders Monisha A. Kumar, MD, and David G. Coughlin, MD, created a tool to identify the most common causes of readmissions. With this information, a sheet was created to evaluate transfers from the ICU. Patients that were flagged as high risk went through a different transfer process, including enhanced communication prior to transfer and assessment of respiratory therapy after transfer. During the nine months of study, compliance with the new protocol was high with nearly 80 percent of patients screened. At the end of the study, they had decreased the incidence of readmissions from 6.7 percent to 2.8 percent. A survey of providers at the end of the project showed that 85 percent would be in favor of this new process becoming standard of care.
Anant Shenoy, MD, FAAN, vice chair of the Quality Measure Subcommittee, said, “These projects show how focused, clinician-driven changes can have a big impact on safety and quality without burdening neurologists and their treatment teams.” The AAN is interested in hearing your success stories. To learn more, contact quality@aan.com.
Medication error is a common problem in patients with Parkinson’s disease that are hospitalized due to the time sensitivity of the medication regimen. A review of patients at Northwestern University over the last year showed that 50 percent experienced medication misadministration. The project leader, Danielle Larson, MD, met with many stakeholders within the hospital to identify barriers to proper medication administration for Parkinson’s patients. An admission order set was
AANnews • July 2019 7
Tools & Resources
Understanding How You Get Paid: Part Two In part one of this series published in the May AANnews® (http://bit.ly/2F9GSey), you learned how CPT codes are identified by the Centers for Medicare & Medicaid Services (CMS) and the American Medical Association (AMA) for review and potential changes in reimbursement. This article focuses on what happens after a code has been identified and the role the AAN plays. If a CPT code reported by neurologists is identified as potentially misvalued, the AAN will carefully look at the utilization history for an explanation. In many cases, there is a reasonable explanation for an increase, such as a new technology or a new service that health care providers are adopting as part of their practice. In this instance, the AAN will propose the code be removed from the screen and no action is required. Another explanation might be outdated CPT code language which has led to incorrect coding and increased utilization. The appropriate recommendation is this case would be reviewed by the CPT Editorial Panel to update the code language to reflect current practice. Unfortunately, an increase in utilization could be due to miscoding or inappropriate use, in which case the medical specialty society may propose a delay in review to allow member education to correct the mis-coding. Alternately, the specialty may be directed to survey the CPT code for updated valuation. The survey process occurs via the AMA Relative Value Scale Update Committee (RUC) which recommends relative values for physician work and direct practice expense to CMS.
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AANnews • July 2019
To put this process in context, we can look to long-term EEG monitoring code 95951 which was identified by CMS in 2017 due to a rapid increase in utilization (more than 100 percent in a five-year period). The AAN (in collaboration with the American Clinical Neurophysiology Society and National Association of Epilepsy Centers) proposed revisions to 95951 and other long-term EEG monitoring codes to more accurately describe the services provided. The AMA CPT Editorial Panel established a new code set which was reviewed by the RUC and will be effective January 1, 2020. The values the RUC recommended for the new longterm EEG code were submitted to CMS, which will publish its proposed payment rates in the Medicare Physician Fee Schedule Proposed Rule in July of 2019 this year. Following publication of the Proposed Rule, the AAN will have the opportunity to submit comments specific to the new code set values. New and revised codes remain under AMA embargo until the release of the next calendar year’s code set, typically in September each year. Part three in this series of AANnews® coding articles will introduce new codes for 2020.
Policy & Guidelines
Summit with Payers Provides Exchange of Concerns, Collaboration The AAN hosted a summit with payers at the Annual Meeting in Philadelphia to share concerns and ideas to help neurologists and their patients. One of the current biggest frustrations for patients, providers, and payers is the rising cost of treatments. Rising drug prices are limiting patients’ access to care for both new, novel treatments and well-established treatments.
Capitol Hill Report Jones
Prior to the summit, the AAN had surveyed and listened to members to understand what gets in their way of providing high-quality neurologic care. In Philadelphia, the Payment Policy Subcommittee met with payer representatives to discuss collaborative efforts to reduce barriers to treatments including streamlining prior authorization and approval processes, minimizing step therapy, and peer-to-peer requirements. The payers discussed specific issues with claims submissions that cause delays in approvals and how neurologists can ensure their claims have all the data needed to get through their system. The payers expressed appreciation for the AAN’s evidence-based practice guidelines when they make coverage decisions and would like even more guidance around appropriate, cost-effective therapies. AAN Board member and Advocacy Committee Chair Nicholas E. Johnson, MD, FAAN, who chaired the AAN’s Drug Pricing Task Force, presented on high cost drugs in neurology and that the AAN is exploring how to assist in developing value models for neurologic drugs and advocating on the state and federal level for better access. “This was an exciting and productive summit meeting with payers on issues burdensome to neurologists and barriers for our patients,” said Elaine C. Jones, MD, FAAN, chair of the Coding and Payment Policy Subcommittee. “We look forward to continuing the conversation and ensuring appropriate neurologic treatments are available to our patients.”
Capitol Hill Report presents regular updates on legislative and regulatory actions and how the Academy ensures that the voice of neurology is heard on Capitol Hill. It is emailed to US members twice monthly and is posted at AAN.com/view/HillReport. Below are some recent highlights.
Prior Authorization Bill Introduced in the House Last month, several key members of Congress introduced bipartisan legislation that aims to increase transparency and streamline prior authorization (PA) in the Medicare Advantage (MA) program. The bill, the Improving Seniors’ Timely Access to Care Act of 2019, was introduced in the House by Reps. Suzan DelBene (D-WA), Mike Kelly (R-PA)—both of whom serve on the important Ways and Means Committee which oversees this issue—along with two physician members of Congress, Ami Bera, MD (D-CA), and Rodger Marshall, MD (R-KS). The bill comes with the strong endorsement from the Regulatory Relief Coalition, of which the AAN is a member. This bill was inspired by feedback provided by the provider community, especially members of the Regularity Relief Coalition, who for years have shared stories and data explaining the challenges posed by prior authorization and its impact on patient care. To accomplish the objectives of streamlining prior authorization process and increasing transparency, the bill would: Give providers greater access to criteria for PA determinations Require MA plans to compile annually and publish publicly:
A list of services subject to PA Rates of initial approvals and successful appeals Time delays resulting from PA
Adopt MA beneficiary protections via federal rulemaking to improve PA transparency, identify services with high approval rates, provide continuity of care when changing coverage, and ensure that PA programs adhere to evidence-based guidelines Expand use of electronic prior authorization (ePA) in MA Among the summit attendees who shared their thoughts were Don Liss, MD, vice president for medical affairs at CVS Health (speaking), and (from left to right) AAN representatives Bradley C. Montgomery and Pearce Korb, MD, FAAN, and Cigna medical directors Patricia J. Loudis, MD, MBA, and Jennifer Yanoschak, MD.
Contact your representative and ask him or her to cosponsor the Improving Seniors’ Timely Access to Care Act of 2019.
AANnews • July 2019 9
Conferences & Community
2019–2021 Committee, Subcommittee, and Work Group Chairs The following appointments have been made by President James C. Stevens, MD, FAAN, for chairs of Academy committees, subcommittees, and work groups for the 2019–2021 term that began in May. AAN Delegation to the AMA Mark Milstein, MD, FAAN
Fall Conference Work Group Jonathan Graff-Radford, MD
Medical Student Diversity Subcommittee Maisha T. Robinson, MD, MS
Advocacy Committee Nicholas E. Johnson, MD, FAAN
Graduate Education Subcommittee Jaffar Khan, MD, FAAN
Medical Student Pipeline Work Group A. Gordon Smith, MD, FAAN
Advocacy Engagement Subcommittee David B. Watson, MD, FAAN
Grievance Committee William P. Cheshire, Jr., MD, FAAN
Meeting Management Committee Carlayne E. Jackson, MD, FAAN
Board Planning Committee Carlayne E. Jackson, MD, FAAN
Guidelines Subcommittee Alexander D. Rae-Grant, MD, FAAN
BrainPAC Executive Committee Glen R. Finney, MD
Health Policy Subcommittee David A. Evans, MBA
Member Application Review Subcommittee Gregory D. Cascino, MD, FAAN
Business Innovation Subcommittee James N. Goldenberg, MD, FAAN
Health Services Research Subcommittee Gregory J. Esper, MD, MBA, FAAN
Bylaws Committee James C. Stevens, MD, FAAN
History and Archives Committee Douglas J. Lanska, MD, FAAN
Care Delivery Subcommittee Joel M. Kaufman, MD, FAAN
Industry Relations Subcommittee Jonathan P. Hosey, MD, FAAN
Career Leadership Subcommittee Jeffrey C. McClean II, MD, FAAN
International Subcommittee Jerome H. Chin, MD, PhD, MPH, FAAN
CEO Search Committee Ralph L. Sacco, MD, MS, FAHA, FAAN
Joint Audit Committee George K. York III, MD, FAAN
Child Neurology Work Group Ann H. Tilton, MD, FAAN
Joint Coordinating Council on Equity, Diversity, Inclusion, and Disparities Jeffrey C. McClean II, MD, FAAN
Clinical Research Subcommittee Deborah Hall, MD, PhD, FAAN Coding and Payment Policy Subcommittee Elaine C. Jones, MD, FAAN Compensation Committee Janis M. Miyasaki, MD, MEd, FRACPC, FAAN Conference Subcommittee Joseph I. Sirven, MD, FAAN Digital Strategy Subcommittee Bert B. Vargas, MD, FAAN Diversity Leadership Subcommittee Yazmin Odia, MD, FAAN Education Committee A. Gordon Smith, MD, FAAN eLearning Subcommittee Richard S. Isaacson, MD, FAAN Ethics, Law, and Humanities Committee Leon G. Epstein, MD, FAAN Fair Hearing Panel Committee Daniel G. Larriviere, MD, JD, FAAN
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AANnews • July 2019
Joint Coordinating Council on Wellness Jennifer Rose Molano, MD, FAAN Heidi B. Schwarz, MD, FAAN
Member Engagement Committee Gregory D. Cascino, MD, FAAN Member Research Subcommittee Benn E. Smith, MD, FAAN Nominations Committee Timothy A. Pedley, MD, FAAN Pipeline Subcommittee Rana R. Said, MD, FAAN Practice Management and Technology Subcommittee Allison L. Weathers, MD, FAAN Publications Committee Robert A. Gross, MD, PhD, FAAN Quality Committee Lyell K. Jones, Jr., MD, FAAN Quality Measures Subcommittee Adam Webb, MD, FAAN
Joint Finance Committee Janis M. Miyasaki, MD, MEd, FRACPC, FAAN
Regional Conference Subcommittee Jonathan Graff-Radford, MD
Joint Investment Committee Ralph F. Józefowicz, MD, FAAN
Registry Subcommittee Sarah M. Benish, MD, FAAN
Journal Arbitration Committee James L. Bernat, MD, FAAN
Research Program Subcommittee Paul M. George, MD, PhD, MSE
Leadership Development Committee Terrence L. Cascino, MD, FAAN
Resident Leadership Subcommittee Jaffar Khan, MD, FAAN
Leadership Engagement Subcommittee Hope O'Brien, MD, FAAN
Science Committee Natalia S. Rost, MD, MPH, FAHA, FAAN
Leadership for Women Subcommittee Cynthia L. Comella, MD, FAAN
Sections and Subspecialties Subcommittee Pierre Fayad, MD, FAAN, FAHA
Live Well, Lead Well Work Group Jennifer Rose Molano, MD, FAAN Medical Economics and Practice Committee Brad C. Klein, MD, MBA, FAAN
Undergraduate Education Subcommittee Madhu Soni, MD, FAAN
Conferences & Community
Griggs Receives 2019 Leading in Excellence Through Mentorship Award AAN Past President Robert C. Griggs, MD, FAAN, joined Carlayne E. Jackson, MD, FAAN, and Ralph F. Józefowicz, MD, FAAN, as the most recent recipient of the AAN’s Leading in Excellence Through Mentorship award. Griggs was nominated by 2018–2019 Transforming Leaders Program graduate Jennifer L. Hopp, MD, FAAN, and formally was recognized during the Celebrating Future Leaders Reception at the 2019 Annual Meeting in Philadelphia. The Leading in Excellence Through Mentorship recognition is presented annually to an exceptional mentor who has participated in one or more of the AAN’s Leadership Programs and through their expertise and guidance made a significant impact in the life and career of their mentee(s), encouraging them to maximize their potential and successfully achieve the goals set forth in their program. In nominating her mentor, Hopp wrote, “I thought quite a bit about what and how to convey about Robert (Berch) Griggs as a nominee for this leadership award. It may sound trite, but my experience in a short period of time with Berch has truly been transformative.” Hopp went on to say, “I don’t think I’ve ever had a mentoring relationship that involved such sincere interest in me as an
Celebrating Future Leaders Reception
individual. I was struck by how many questions he asked of me. Gathering background data makes sense, of course, especially Griggs Hopp since we didn’t know each other nor work at the same institution, but I also soon realized that he was truly personalizing his recommendations and suggestions to my specialty, to my background, and even to the infrastructure of my department. It was brilliant.” “Being a mentor in the Transforming Leaders Program has its challenges,” continued Hopp, “as the participants are mid-career and have typically already developed a well-worn path of work and leadership. Not only has my mentoring relationship with Berch been fruitful for the development of my Transforming Leadership Program project in the Academy, developing connections with other leaders in epilepsy, and kick-starting my clinical research career (all literally within three months), but it has been one of the most energizing relationships I have had in my professional life. I have found Berch to be an amazing mentor as he challenges me not only to do more, but to do more thoughtfully, and in truly fun ways that keeps me recharged on a regular basis. The relationship truly mitigates any potential burnout that may have been creeping in. Before starting to work with Berch, I had thought that perhaps I had reached the ceiling of my clinical and research career and that it would be difficult, if not impossible, to reinvent and reestablish prior held goals in leadership and research development. Those concerns have now completely dissolved with the establishment of this partnership and, I hope, friendship. My perspective and my goals in my career have been transformed.”
Staff Creativity, AAN Values Strike a Chord The AAN again this year sponsored a piano in its Sensory Garden as part of the Minneapolis Downtown Council’s Pianos on Parade campaign designed to add vibrancy to the city by placing 25 artist-painted pianos throughout downtown Minneapolis. This year, as a staff engagement activity, AAN staff worked together with a local artist to paint the piano, weaving in the AAN’s values as part of the design. The piano was available for the public to enjoy outside the AAN’s front door throughout the month of June.
AANnews • July 2019 11
© Neurelis, Inc. 2019. All rights reserved. US-PRC-19-00001
IT’S TIME TO RETHINK SEIZURE RESCUE In addition to daily antiepileptic medication, patients at risk for increased seizure activity should be prepared with a seizure response plan that includes an on-hand rescue treatment to stop seizures.
We’re changing the conversation. Visit LetsTalkSeizures.com
Conferences & Community
Fall Conference Registration Open, Get Best Rates By August 15 continued from cover Set for October 18 through 20 at The Cosmopolitan of Las Vegas, this year’s conference will offer a robust lineup of programming geared toward both neurologists and integral neurology care team members such as advanced practice providers and business administrators. The program includes: Neurology updates on the most relevant topics in neurology, including headache, sleep, neuro-ophthalmology, autoimmune neurology, neurogenetics, MS, epilepsy, stroke, neuro-oncology, dementia, and more Practice management programming for neurologists and business administrators covering coding, patient access and engagement, efficiency improvements, team-building approaches, management, value-based models, and more Neuroscience in the Clinic Sessions on traumatic brain injury and headache Continuum® Self-assessment Neuroimaging for the General Neurologist Clinical Pearls: Learning from Complex Cases— Simple Lessons that Apply to Everyday Problems Controversies in Neurology and Contemporary Clinical Issues Plenary Sessions Contemporary Concerns About Brain Death Determination Skills Workshop on Neuromuscular Ultrasound (additional fee required) The Fall Conference’s breadth of programming offers maximum value, flexibility, and customization so attendees can
easily tailor a personalized schedule to their specific interests and needs. The all-inclusive registration does not include the Saturday workshop or the advanced practice provider pre-conference, but discounts are available to registrants who attend both the pre- and main conference. Be sure to register by August 15 for the biggest early registration savings.
Full-day Pre-conference for APPs Debuts Prior to Fall Conference
Critical players on the neurology care team are invited to come one day early and take part in the new APP Pre-conference on October 17, just prior to the AAN Fall Conference. The pre-conference will feature a full day of continuing education programming that will dive deep into a variety of topics ranging from neurology fundamentals to clinical case studies.
Highlights include: Neurology fundamentals including clinical correlations of neuroanatomy and use and interpretation of neuroimaging and neurophysiology techniques in clinical practice Common topics in clinical neurology, including headache, spine disorders and radiculopathy, and MS Networking opportunities Register for the event on a stand-alone basis or bundle it with Fall Conference registration to save! Learn more at AAN.com/view/APPConference.
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AANnews • July 2019
Conferences & Community
Industry Roundtable Convenes to Learn, Recognize, and Celebrate at the 2019 Annual Meeting Joining over 15,000 attendees at this year’s Annual Meeting in Philadelphia were representatives from 36 member companies of the AAN’s Industry Roundtable (IRT). Throughout the week, IRT members engaged in transparent dialogue, special recognition opportunities, and celebration of the IRT’s 25th Anniversary. Through education and engagement, IRT members deepened their understanding of and involvement with the AAN to better align mutual priorities. To learn more about the IRT, visit AAN.com/view/IRT.
YEAR ANNIVERSARY
Lyell K. Jones, Jr., MD, FAAN, gave a detailed talk on the Axon Registry.
As part of the Industry Roundtable’s 25th anniversary celebration, the IRT Breakfast featured subspecialty experts Ralph L. Sacco, MD, MS, FAHA, FAAN (stroke); John C. Morris, Jr., MD, FAAN (Alzheimer’s disease); and Brenda Banwell, MD, FAAN, (pediatric multiple sclerosis) speaking on some of the most significant neurological advances in the past and implications for the future.
Orientation for new members of Industry Roundtable with Board member and Physician Liaison to Industry Jonathan P. Hosey, MD, FAAN. AANnews • July 2019 15
B R A IN DI SEASE AFFEC TS O NE IN SI X PEOPLE. L E T ’S GET TO ZERO.
Every brain disease and disorder is connected. Through our unique approach of bringing neurologists, researchers and experts together to examine the whole brain, we get the whole picture and make an incredible impact on the lives of patients and caregivers. Brain diseases are all connected. When we cure one, we’ll cure many. Learn more about over 400 brain diseases and disorders at AmericanBrainFoundation.org.
Education & Research
UCNS Moves to Virtual Proctoring for Initial Certification Examinations In response to ongoing feedback from certification examinees, the United Council for Neurologic Subspecialties (UCNS) will provide a more flexible and user-friendly experience for physicians by implementing virtual live proctoring for initial certification examinations. Previously, all certification examinations took place at Pearson Vue testing centers. “We heard the frustrations of physicians who were unable to schedule at testing centers when and where it was most convenient for them,” said Paul G. Fisher, MD, chair of the UCNS Board of Directors. “Virtual proctoring will provide physicians with the flexibility and convenience they desire.” Changing to virtual proctoring, examinations can now be scheduled 24/7 during the examination week for the day, time, and location that is convenient for the examinee. This change reduces the amount of out-of-office time and expense required for examinees to travel to a testing center. Examinations may be taken on a personal computer or laptop that has camera capabilities and internet access. Examinees will have an opportunity to test their equipment and internet connection in advance of their examination date and will receive online session registration and instructions in advance of their examination. Security of the examinations remains a priority and is accomplished through virtual candidate identification
confirmation. Examinees will provide virtual proctors with a room and desktop scan to assure that no materials, phones, or other devices are available to the candidate during the duration of the examination. Through the candidate login, the computer’s browser is locked down Fisher for the duration of the examination and all candidates agree to an online statement of ethical conduct. The proctor-to-candidate ratio is no more than one proctor to four candidates, and all proctors are trained to handle basic online issues as needed during examinations with advanced support available during published days and times. “It is our goal to use the technology that is now readily available to improve the UCNS certification examination experience for physicians while maintaining the security and integrity of our examinations,” added Fisher.
AANnews • July 2019 17
Education & Research
Applications Open for 2020 Research Program Opportunities continued from cover
Career Development Award
Funded by the American Academy of Neurology, this award provides $150,000 per year for three years to support junior investigators interested in an academic career in neurology.
*Two Awards Available
Clinical Research Training Scholarship
Funded by the American Academy of Neurology, this award commits a total of $150,000 over two years to encourage young investigators in clinical studies.
*Three Awards Available
Clinical Research Training Scholarship in ALS
Funded by The ALS Association and American Brain Foundation, in collaboration with the American Academy of Neurology, this award commits a total of $150,000 over two years to support clinical research and studies in ALS.
Clinical Research Training Scholarship in Lewy Body Diseases
Funded by The Mary E. Groff Charitable Trust, the Alzheimer's Association, and the American Brain Foundation, in collaboration with the American Academy of Neurology, this award commits a total of $150,000 over two years to support education and research in Lewy body diseases.
Clinical Research Training Scholarship in Neuromuscular Disease
Funded by the Muscle Study Group and American Brain Foundation, in collaboration with the American Academy of Neurology, this award commits a total of $150,000 over two years to trainee fellowships that promote neuromuscular clinical and translational research.
Clinical Research Training Scholarship in Parkinson’s Disease
Funded by the Parkinson’s Foundation and American Brain Foundation, in collaboration with the American Academy of Neurology, this award commits a total of $150,000 over two years to encourage young investigators in clinical studies in Parkinson’s disease.
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AANnews • July 2019
Clinical Research Training Scholarship in Tourette Syndrome
Funded by the Tourette Association of America and American Brain Foundation, in collaboration with the American Academy of Neurology, this award commits a total of $150,000 over two years to encourage young investigators in clinical studies related to Tourette syndrome.
Clinician Scientist Development Award in Multiple Sclerosis
Funded by the National Multiple Sclerosis Society and American Brain Foundation, this award supports three years of research training in an environment where talented young clinicians address problems in MS with the most current scientific tools.
Lawrence M. Brass Stroke Research Award
Funded by the American Heart Association/American Stroke Association and the American Brain Foundation, this award provides one or two years of financial support to enhance the integrated research and clinical training of postdoctoral applicants who are not yet independent.
McKnight Clinical Translational Research Scholarship in Cognitive Aging and Age-Related Memory Loss Funded by the McKnight Brain Research Foundation through the American Brain Foundation and the American Academy of Neurology, this award commits a total of $150,000 over two years to encourage young investigators in clinical studies relevant to age-related cognitive decline and memory loss.
*Two Awards Available
Neuroscience Research Training Scholarship
Funded by the American Academy of Neurology, this award commits a total of $150,000 over two years to encourage young investigators in good laboratory or preclinical research.
*Two Awards Available
Harness the Power of Your Quality Data with the Axon Registry
Practice Research Training Scholarship
Funded by the American Academy of Neurology, this award commits a total of $150,000 over two years to support clinical research that evaluates translation of evidence into best clinical practice.
Richard Olney Clinician Scientist Development Award in ALS
Funded by The ALS Association and American Brain Foundation, in collaboration with the American Academy of Neurology, this award commits a total of $240,000 for three years to support ALS research.
Robert W. Katzman, MD Clinical Research Training Scholarship in Alzheimer’s or Related Disorders
Funded by the Alzheimer's Association and the American Brain Foundation, in collaboration with the American Academy of Neurology, this award commits a total of $150,000 for two years to support research of Alzheimer’s and related dementias.
Susan Spencer, MD Clinical Research Training Scholarship in Epilepsy
Funded by the American Epilepsy Society, the Epilepsy Foundation, and American Brain Foundation, in collaboration with the American Academy of Neurology, this award commits a total of $150,000 over two years in support of clinical research training in the field of epilepsy.
Got Epic? We can work with them. The Axon Registry® is a qualified clinical data registry focused on quality improvement in neurologic care. It crunches real-time data for FREE to help your institution: • Create quality improvement projects with your staff • Benchmark your outcomes against others in your institution or nationally • Reduce the burden of unnecessary documentation • Receive credit for multiple MOC requirements • Demonstrate the value of neurology to public and private payers
Put the Axon Registry to work for you. Discover how at
AAN.com/view/GoAxon
AAN.com/careers
Visit the AAN’s Neurology Career Center to view hundreds of additional jobs and sign up for customized, confidential notifications when positions of interest are added. Neurology Physician—Baptist Neurology at Amelia Island. Renowned team- world class quality of life. Northeast Florida’s leader in neurological care is seeking a General Neurologist to join a rapidly-growing and highly-distinguished clinical team serving one of the nation’s most sought after communities and destinations, Amelia Island. Frequently recognized as one of the top islands and best towns in the United States, the area offers physicians an unmatched quality of life in addition to rewarding career opportunities. The successful candidate will enjoy a balanced schedule providing an appealing blend of both outpatient and inpatient care. Focused on consultative general neurology, this key specialist opportunity is supported by a robust hospitalist program, skilled sub-specialists across the medical staff teams, the region’s largest primary care network and the comprehensive backing of a renowned tertiary facility featuring a 24-bed neuro critical care unit and one of the nation’s leading cerebrovascular programs. The strengths of our system include: Baptist Neurology is a multi-disciplinary team providing both inpatient and outpatient neurology care across Northeast Florida as part of the Baptist Neuroscience Institute, a multi-specialty program spanning the spectrum of neurological conditions including stroke, neurophysiology disorders, epilepsy, MS, neuro-oncology, memory disorders, movement disorders, cerebrovascular disease and neurosurgical spine. Baptist Medical Center Nassau is a nationally-recognized and highly-advanced community hospital ranked among the best in the U.S. for quality and safety of patient care. The 62 bed facility features state-of-the-art technology, leading–edge protocols and a highly-distinguished medical staff. As an integral part of coastal communities across Northeast Florida and Southeast Georgia, Baptist Medical Center Nassau provides a full spectrum of inpatient and outpatient services and is proud to be part of the Baptist Health system, the region’s most preferred health system since 1990, ranking highest in the categories of best doctors, best nurses, best quality and best reputation. Baptist Health specialty physicians enjoy the ability to build thriving and robust practices as part of the largest physician network in the region, including more than 250 primary care providers at the core of the health system. With five nationally-recognized hospitals and physician teams providing care across the spectrum of inpatient and outpatient services, Baptist Health offers physicians the opportunity for exceptional careers backed by renowned reputation, outstanding infrastructure and a patient-centered culture at the heart of our mission. Located just off the coast of Northeast Florida, Amelia Island is home to some of the nation’s most sought after quality of life and the best cost of living that the Sunshine State has to offer. With 13-miles of beautiful beaches, abundant native wildlife, pristine waters and hospitable locals, this barrier island has long been a beloved destination for visitors and residents alike. Combining old southern charm with modern Florida flair, the area has been recognized for its unique culture offering equal parts adventure and relaxation: world famous quality of life. Top Beaches in Florida USA Today. Top 3 Islands in the U.S. Conde Nast Traveler. Top 4 Happiest Seaside Towns Coastal Living. Best Small Towns Southern Living. Top Islands in America CNN Travel. To apply for this job, contact Jennifer Wallace at PhysicianCareers@bmcjax.com or at (904) 202-5029. https://www.baptistjax.com/about-us/physician-opportunities/ neurology-physician-baptist-neurology-at-amelia-island. General Neurologist for Busy Practice in Florida. Excellent opportunity for a new or experienced neurologist seeking a busy, collegial physician owned group. Our neuroscience program is dedicated to the comprehensive diagnosis and treatment of patients with a wide variety of neurological disorders so fellowship training in Headache, Behavioral Neurology, Sleep Medicine, Neuromuscular, Stroke, or Movement Disorders is helpful. Our expanding in-house neuroscience program boasts an accredited Sleep Disorders Center, EEG, EMG, evoked potential capabilities and neuroimaging capabilities (MRI, CT, PET, SPEC). Convenient access to one 800-bed hospital located 2 blocks from the Clinic. Watson Clinic is a physician owned group practice with over 220 physicians and maintains a strong referral base with over 50 primary care specialists in outpatient and inpatient practices. Our convenient location between Tampa & Orlando provides easy access to 2 international airports just 45 minutes away! Watson Clinic fosters an atmosphere of clinical excellence in an area offering a high quality of life, complete with affordable housing, safe neighborhoods, and a wealth of recreational activities year-round including golf, football, hockey, baseball, basketball as well as local attractions and no state income tax. In addition to a salary guarantee, we offer a signing bonus, paid relocation assistance, retirement program, malpractice insurance along with many other benefits. Partnership is offered after 2 years. Job Requirements are to be Board certification or eligibility by the American Board of Psychiatry and Neurology.
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To apply for this position, contact Kacee Fagan at WCPhysicians@ watsonclinic.com or at (863) 680-7380. Epileptologist and Movement Disorders Neurologists for Norton Neuroscience Institute. Epileptologist. Louisville, Kentucky, United States. Norton Neurology Services, a part of Norton Neuroscience Institute, is seeking a fellowship-trained physician to provide movement disorder services. Norton Neuroscience Institute is composed of 65 neuroscience providers, including 19 neurologists, 14 neurosurgeons, two neuropsychologists and more than 30 advanced practice providers. The ideal candidate will join three fellowship-trained epileptologists and three advanced practice providers. Our program features a six-bed, state-of the-art Level IV Epilepsy Monitoring Unit located at Norton Brownsboro Hospital. Opportunity to provide inpatient and outpatient epilepsy and general neurology services. Opportunity to participate in the annual Norton Neuroscience Institute Symposium, as well as other continuing medical education events. Weekly neuroscience clinical conference with neurosurgery and neurology providers. Research opportunities and support available through the Norton Healthcare Research Office. Movement Disorders Neurologist. Louisville, Kentucky, United States. Norton Neurology Services, a part of Norton Neuroscience Institute, is seeking a fellowship-trained physician to provide movement disorder services. Norton Neuroscience Institute is composed of 65 neuroscience providers, including 19 neurologists, 14 neurosurgeons, two neuropsychologists and more than 30 advanced practice providers. The ideal candidate will join two fellowship-trained movement disorder neurologists. The practice enjoys referral patterns from other neurologists in the practice as well as other physicians and providers within Norton Medical Group. Ability to practice majority movement disorder neurology. No mandatory system stroke call. Opportunity to provide general inpatient neurology services. Opportunity to participate in the annual Norton Neuroscience Institute Symposium, as well as other continuing medical education events. Weekly neuroscience clinical conference with neurosurgery and neurology providers. Research opportunities and support available through the Norton Healthcare Research Office. Neurological rehabilitation services. Because of an increasing elderly population in Greater Louisville, Parkinson’s disease is a significant health concern. As the region’s leader in providing care for neurological conditions, Norton Neuroscience Institute is dedicated to offering the most advanced treatments for people with Parkinson’s disease. Cressman Neurological Rehabilitation, a service of Norton Neuroscience Institute, provides rehabilitation for patients managing neurological conditions. Patients have access to some of the most advanced technology and specialized services in one location to help with gait, balance, strength, flexibility, speech, fine motor skills, swallowing, driving, cognition, vision and more. Specialized features include the ZeroG Gait and Balance System, the Biodex Gait Training System, deep brain stimulation, Parkinson Wellness Recovery-certified therapists, videostroboscopy, and one-on one personalized training and follow-up programs. About Norton Neuroscience Institute. Established in early 2009, Norton Neuroscience Institute is the region’s leading provider of neurological care. The comprehensive program offers advanced treatment for complex neurological disorders, including ALS; aneurysms; brain tumors; epilepsy; headache and concussion; movement disorders, including Parkinson’s disease; multiple sclerosis; pediatric neurosurgery; spinal injuries and disorders; stroke; and more. In 2016, Norton Neuroscience Institute was the first in the region to use ROSA, a robotic surgical assistant, to provide advanced treatment for patients with epilepsy and brain tumors. Norton Neuroscience Institute also is one of the first in the region to use systems such as NeuroPace and NeuroBlate for performing minimally invasive surgical procedures. Patients and their families have access to patient navigators and support services through the Norton Neuroscience Institute Resource Center, the Center for Independent Living and rehabilitation services. The resource center offers health information and assistance with getting connected to clinical trials, educational programs, support services, community resources and more to help patients live better. More information is available at NortonNeuroscienceInstitute.com. Job Requirements are to have a Medical degree/diploma, Residency/fellowship certification, and a Kentucky medical license or license eligible. To apply for this job, contact Amanda Bailey at amanda.bailey@nortonhealthcare. org or at (502) 439-5144. https://nortonhealthcare.com. General Neurologist. Our private General Neurology practice, located in beautiful Middlebury, CT, offers a unique opportunity for a general neurologist interested in private practice to join our very successful team of physicians who are dedicated to and focused on providing the highest quality of patient care
while remaining independent. Successful candidates will focus primarily on outpatient general neurology while subsequent specialty training in all areas is an added plus. Discussion about areas of interest are welcomed. Located in close proximity to both New York City and Boston our progressive community offers an abundance of quality, nationally ranked schools, cultural events and seasonal activities. In less than one hour you have the opportunity to enjoy the extraordinary New England coastline or mountains which surround our beautiful area. We offer a highly competitive compensation package with salary discussions starting at 400K per year, plus a generous sign on bonus. Relocation packages are customizable and our full benefit packages include initial income guarantee. Paid call is currently 1:6 and transfers of H1 Visas are welcome with costs covered by the practice. Interested applicants may send CV with cover letter to cannulli@waterburyneurology.com. Job Requirements are to have a current MD License, current Neurology Board Certification or Board Eligibility and Subspecialties welcome. To apply for this position, contact Catherine Annulli at CANNULLI@ waterburyneurology.com or at (203) 758-8995, Ext. 5. Neurology Position. Princeton, New Jersey. Premier highlyregarded seven-person Neurology practice located in the Princeton, NJ area is seeking a Neurologist with a Neurophysiology fellowship preferred (other sub-specialties welcome to respond) to join their established and growing practice. Practice: You will be joining a collaborative group who stress quality care but at the same time earn in the top 80th percentile of Neurologists around the country. Private practice with a partnership track. Clinical duties will include reading EEGs and performing EMGs. The need for a Neurologist is driven by the group’s continued rapid growth. Consulting privileges at just one hospital. Light night call; tele-neurology is covered from a tertiary care facility. Very competitive income along with production incentives and a full benefits package. Community: The Princeton area is one of the most desired areas to live on the East Coast. Outstanding schools, beautiful homes, great shopping, and superb restaurants are just a few reasons why professionals love calling the area home. Home of Princeton University. Princeton’s proximity to Philadelphia and New York greatly increases the appeal. There are many Neurology positions available around the country, but few will offer you an extremely collegial practice setting, a great deal of professional and personal satisfaction, and outstanding financial rewards while living and practicing in a location that is highly sought after. Please contact: Ken Sammut, Vice President of Recruiting, Cejka Search, (888) 372-9415, ksammut@cejkasearch.com. Permanent Outpatient Neurology Physician Job in East Lansing, Michigan. Compass Health, a physician owned multi-specialty group, is seeking a Board Eligible/Board Certified Neurologist to join our 100% outpatient practice in our state-of-the-art rehabilitation center located in East Lansing, Michigan. Outpatient only. General Neurology with a focus on EMGs, nerve conduction studies, and neurological evaluations. No call or weekends. Be a part of an integrated rehabilitation medicine practice. Physician-Led Organization. Multi-Specialty Support. Terrific energetic staff to work alongside. Compensation Package: 2-year guarantee, productivity incentives, sign-on, full benefits package, and more. East Lansing, Michigan is the proud home of Michigan State University. East Lansing offers an unbeatable combination of historic small-town atmosphere and cosmopolitan sophistication. Outdoor recreation is abundant in East Lansing. You can also take day trips to Grand Rapids, Detroit, Toledo, and even Toronto. Interested candidates please contact: Shelby Waltrip, (314) 236-4580, swaltrip@cejkasearch.com. AANnews® Classified Advertising
he AAN offers a complete package of print, online, T and in-person recruitment advertising opportunities. Visit careers.AAN.com for all AAN options, rates, and deadlines. d copy for the September 2019 print edition of A AANnews must be submitted by August 1, 2019. The same deadline applies to changes/cancellations. he American Academy of Neurology reserves the T right to decline, withdraw, or edit advertisements at its discretion. Every care is taken to avoid mistakes, but the responsibility for clerical or printer errors does not exceed the cost of the ad.
Dates & Deadlines
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JULY 1
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Deadline: Early Deadline to Apply for UCNS Neurocritical Care Certification Examination Apply by July 1 and save $500 UCNS.org/go/subspecialty/neurocritical/ certification
Webinar: Increasing Revenue in Your Practice: Care Models, Ancillary Services, and Other Strategies Register by August 12 AAN.com/view/pmw19
Deadline: Fall Conference Advance Registration and Hotel Deadline AAN.com/view/19FC
JULY 18–21
AUGUST 15 Deadline: Fall Conference Early Registration AAN.com/view/Fall
AAN Palatucci Advocacy Leadership Forum AAN.com/view/PALF
JUlY 26–28 Publishing: 19 Brain & Life Ad—Half Page Horizontal> AN Sports Concussion Conference Placed inIndianapolis, AANnews IN 8.25 x 5.25 +0.125 bleed, 4C
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See what you and your patients have been missing! Share inspiring stories, caregiver tips, healthy living articles—delivered in print to your office and online. Spanish issues published four times a year and included with English mailings.
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BrainandLife.org
TROKENDI XR® (topiramate) extended-release capsules for oral use BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION For full prescribing information see Package Insert Rx Only CONTRAINDICATIONS TROKENDI XR is contraindicated in patients: • With recent alcohol use (i.e., within 6 hours prior to and 6 hours after TROKENDI XR use) WARNINGS AND PRECAUTIONS Acute Myopia and Secondary Angle Closure Glaucoma A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness) and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within 1 month of initiating topiramate therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in pediatric patients as well as adults. The primary treatment to reverse symptoms is discontinuation of TROKENDI XR as rapidly as possible, according to the judgment of the treating physician. Other measures, in conjunction with discontinuation of TROKENDI XR, may be helpful. Elevated intraocular pressure of any etiology, if left untreated, can lead to serious sequelae including permanent vision loss. Visual Field Defects Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during treatment with TROKENDI XR, consideration should be given to discontinuing the drug. Oligohydrosis and Hyperthermia Oligohydrosis (decreased sweating), resulting in hospitalization in some cases, has been reported in association with topiramate use. Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases were reported after exposure to elevated environmental temperatures. The majority of the reports have been in pediatric patients. Patients, especially pediatric patients, treated with TROKENDI XR should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when TROKENDI XR is given with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity. Metabolic Acidosis TROKENDI XR can cause hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis). This metabolic acidosis is caused by renal bicarbonate loss due to carbonic anhydrase inhibition by TROKENDI XR. TROKENDI XR-induced metabolic acidosis can occur at any time during treatment. Bicarbonate decrements are usually mild to moderate (average decrease of 4 mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10 mEq/L. Conditions or therapies that predispose patients to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, ketogenic diet or specific drugs) may be additive to the bicarbonate lowering effects of TROKENDI XR. Metabolic acidosis was commonly observed in adult and pediatric patients treated with immediate-release topiramate in clinical trials. Manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates, which may decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Reductions in length and weight were correlated to the degree of acidosis. TROKENDI XR treatment that causes metabolic acidosis during pregnancy can possibly produce adverse effects on the fetus and might also cause metabolic acidosis in the neonate from possible transfer of topiramate to the fetus. Measurement of Serum Bicarbonate in Epilepsy and Migraine Patients Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing TROKENDI XR (using dose tapering). If the decision is made to continue patients on TROKENDI XR in the face of persistent acidosis, alkali treatment should be considered. Interaction with Alcohol In vitro data show that, in the presence of alcohol, the pattern of topiramate release from TROKENDI XR capsules is significantly altered. As a result, plasma levels of topiramate with TROKENDI XR may be markedly higher soon after dosing and subtherapeutic later in the day. Therefore, alcohol use should be completely avoided within 6 hours prior to and 6 hours after TROKENDI XR administration. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED, including TROKENDI XR for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono-and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative
Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. A pooled analysis of data for multiple AEDs determined absolute and relative risk by indication. For every 1,000 patients, the absolute risk for placebo vs drug patients was 1.0 v 3.4 (epilepsy), 5.7 v 8.5 (psychiatric), and 1.0 v 1.8 (other) for a total risk of 2.4 v 4.3. The relative risk for drug patients compared to placebo was 3.5 (epilepsy), 1.5 (psychiatric), and 1.9 (other) for a total relative risk of 1.8. The difference in risk (additional drug patients with events per 1,000 patients) was 2.4 (epilepsy), 2.9 (psychiatric), and 0.9 (other) for a total risk difference of 1.9. The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing TROKENDI XR or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Cognitive/Neuropsychiatric Adverse Reactions Immediate-release topiramate can cause, and therefore expected to be caused by TROKENDI XR, cognitive/ neuropsychiatric adverse reactions. The most frequent of these can be classified into three general categories: 1) Cognitive-related dysfunction (e.g., confusion, psychomotor slowing, difficulty with concentration/ attention, difficulty with memory, speech or language problems, particularly word-finding difficulties); 2) Psychiatric/behavioral disturbances (e.g., depression or mood problems); and 3) Somnolence or fatigue. Adult Patients Cognitive-Related Dysfunction-Rapid titration rate and higher initial dose were associated with higher incidences of cognitive-related dysfunction. In the 6-month migraine prophylaxis controlled trials of immediate-release topiramate using a slower titration regimen (25 mg per day weekly increments), the proportion of patients who experienced one or more cognitive-related adverse reactions was 19% for topiramate 50 mg per day, 22% for 100 mg per day (the recommended dose), 28% for 200 mg per day and 10% for placebo. Cognitive adverse reactions most commonly developed during titration and sometimes persisted after completion of titration. Psychiatric/ Behavioral Disturbances-Psychiatric/behavioral disturbances (e.g., depression, mood) were dose-related for both the adjunctive epilepsy and migraine populations treated with topiramate. Somnolence/Fatigue-For the migraine population, the incidences of both somnolence and fatigue were dose-related and more common in the titration phase. Pediatric Patients In pediatric migraine patients, the incidence of cognitive/ neuropsychiatric adverse reactions was increased in immediate-release topiramate-treated patients compared to placebo. The risk for cognitive/ neuropsychiatric adverse reactions was dose-dependent, and was greatest at the highest dose (200 mg). This risk for cognitive/ neuropsychiatric adverse reactions was also greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age). The most common cognitive/neuropsychiatric adverse reaction in these trials was difficulty with concentration/attention. Cognitive adverse reactions most commonly developed during titration and sometimes persisted for various durations after completion of titration. The Cambridge Neuropsychological Test Automated Battery (CANTAB) was administered to adolescents (12 to 17 years of age) to assess the effects of topiramate on cognitive function at baseline at the end of the Study 3. Mean change from baseline in certain CANTAB tests suggests that topiramate treatment may result in psychomotor slowing and decreased verbal fluency. Fetal Toxicity Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts) and for being small for gestational age. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring. Consider the benefits and risks of TROKENDI XR when administering the drug in women of childbearing potential, particularly when TROKENDI XR is considered for a condition not usually associated with permanent injury or death. TROKENDI XR should be used during pregnancy only if the potential benefit outweighs the potential risk. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus. Withdrawal of Antiepileptic Drugs In patients with or without a history of seizures or epilepsy, antiepileptic drugs, including TROKENDI XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In situations where rapid withdrawal of TROKENDI XR is medically required, appropriate monitoring is recommended. Hyperammonemia and Encephalopathy (Without and
With Concomitant Valproic Acid Use) Topiramate treatment can cause hyperammonemia with or without encephalopathy. The risk for hyperammonemia with topiramate appears dose-related. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid. Postmarketing cases of hyperammonemia with or without encephalopathy have been reported with topiramate and valproic acid in patients who previously tolerated either drug alone. Clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with lethargy and/or vomiting. In most cases, hyperammonemic encephalopathy abated with discontinuation of treatment. The incidence of hyperammonemia in pediatric patients 12 to 17 years of age in migraine prophylaxis trials was 26% in patients taking topiramate monotherapy at 100 mg/day, and 14% in patients taking topiramate at 50 mg/day, compared to 9% in patients taking placebo. There was also an increased incidence of markedly increased hyperammonemia at the 100 mg dose. Dose-related hyperammonemia was also seen in pediatric patients 1 to 24 months of age treated with topiramate and concomitant valproic acid for partial onset epilepsy, and this was not due to a pharmacokinetic interaction. In some patients, hyperammonemia can be asymptomatic. Monitoring for Hyperammonemia Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy. Although not studied, topiramate or TROKENDI XR treatment or an interaction of concomitant topiramate-based product and valproic acid treatment may exacerbate existing defects or unmask deficiencies in susceptible persons. In patients who develop unexplained lethargy, vomiting, or changes in mental status associated with any topiramate treatment, hyperammonemic encephalopathy should be considered and an ammonia level should be measured. Kidney Stones Topiramate increases the risk of kidney stones. As in the general population, the incidence of stone formation among topiramate-treated patients was higher in men. Kidney stones have also been reported in pediatric patients taking topiramate for epilepsy or migraine. During long-term (up to 1 year) topiramate treatment in an open-label extension study of 284 pediatric patients 1-24 months old with epilepsy, 7% developed kidney or bladder stones. TROKENDI XR would be expected to have the same effect as immediate-release topiramate on the formation of kidney stones. Topiramate is a carbonic anhydrase inhibitor. Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH. The concomitant use of TROKENDI XR with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided. Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation. Hydration is recommended to reduce new stone formation. Hypothermia with Concomitant Valproic Acid Use Hypothermia, defined as a drop in body core temperature to < 35ºC (95ºF), has been reported in association with topiramate use with concomitant valproic acid (VPA) both in conjunction with and in the absence of hyperammonemia. This adverse reaction in patients using concomitant topiramate and valproate can occur after starting topiramate treatment or after increasing the daily dose of topiramate. Consideration should be given to stopping TROKENDI XR or valproate in patients who develop hypothermia, which may be manifested by a variety of clinical abnormalities including lethargy, confusion, coma, and significant alterations in other major organ systems such as the cardiovascular and respiratory systems. Clinical management and assessment should include examination of blood ammonia levels. ADVERSE REACTIONS The data described in the following sections were obtained using immediate-release topiramate tablets. TROKENDI XR has not been studied in a randomized, placebo-controlled Phase III clinical study; however, it is expected that TROKENDI XR would produce a similar adverse reaction profile as immediate-release topiramate. 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 practice. Migraine Adults-In the four multicenter, randomized, double-blind, placebo-controlled, parallel-group migraine prophylaxis clinical trials (which included 35 pediatric patients 12 to 15 years of age), most adverse reactions occurred more frequently during the titration period than during the maintenance period. The most common adverse reactions with immediate-release topiramate 100 mg in migraine prophylaxis clinical trials of predominantly adults that were seen at an incidence higher (≥5%) than in the placebo group were: paresthesia, anorexia, weight loss, taste perversion, diarrhea, difficulty with memory, hypoesthesia, and nausea (see Table 7, full Prescribing Information). Adverse reactions that occurred in the placebo-controlled trials where the incidence in any immediate-release topiramate group was 3%-5% and greater than placebo patients were: arthralgia, pharyngitis, anxiety, nervousness, viral infection, coughing, pruritis, urinary tract infection, blurred vision, dyspnea, bronchitis, ejaculation premature, menstrual disorder, gastroenteritis, and dry mouth. The incidence of some adverse reactions (e.g., fatigue, dizziness, somnolence, difficulty with memory, difficulty with concentration/attention) was dose-related and greater at higher than recommended topiramate dosing (200 mg/day) compared to the incidence of these adverse reactions at the recommended dosing (100 mg/day). Of the 1,135 patients exposed to immediate-release topiramate in the adult placebo-controlled studies, 25% discontinued due to adverse reactions, compared to 10% of the 445 placebo patients. The adverse reactions associated with discontinuing therapy in the immediate-release topiramate-treated patients in these studies included paresthesia (7%), fatigue (4%), nausea (4%), difficulty with concentration/attention (3%), insomnia (3%), anorexia (2%), and dizziness (2%). Patients treated in
these studies experienced mean percent reductions in body weight that were dose-dependent. This change was not seen in the placebo group. Mean changes of 0%, -2%, -3%, and -4% were seen for the placebo group, immediate-release topiramate 50 mg, 100 mg, and 200 mg groups, respectively. Pediatric Patients 12 to 17 Years of Age In five randomized, double-blind, placebo-controlled, parallel-group migraine prophylaxis clinical trials, most of the adverse reactions occurred more frequently during the titration period than during the maintenance period. Among adverse reactions with onset during titration, approximately half persisted into the maintenance period. In four, fixed-dose, double-blind migraine prophylaxis clinical trials in immediate-release topiramate treated pediatric patients 12 to 17 years of age, the most common adverse reactions with immediate-release topiramate 100 mg that were seen at an incidence higher (>5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain (see Table 8, full Prescribing Information). Adverse reactions in pediatric patients in controlled migraine trials when the incidence in an immediate-release topiramate dose group was at least 5% or higher and greater than the incidence of placebo were: insomnia, sinusitis, nausea, viral infection, coughing, conjunctivitis, rhinitis, weight loss, and dizziness. Many adverse reactions indicate a dose-dependent relationship. The incidence of some adverse reactions (e.g., allergy, fatigue, headache, anorexia, insomnia, somnolence, and viral infection) was dose-related and greater at higher than recommended immediaterelease topiramate dosing (200 mg daily) compared to the incidence of these adverse reactions at the recommended dosing (100 mg daily). In the double-blind placebo-controlled studies, adverse reactions led to discontinuation of treatment in 8% of placebo patients compared with 6% of immediate-release topiramate-treated patients. Adverse reactions associated with discontinuing therapy that occurred in more than one immediate-release topiramate-treated patient were fatigue (1%), headache (1%), and somnolence (1%). Increased Risk for Bleeding Topiramate is associated with an increased risk for bleeding. In a pooled analysis of placebo-controlled studies of approved and unapproved indications, bleeding was more frequently reported as an adverse reaction for topiramate than for placebo (4.5% versus 3.0% in adult patients, and 4.4% versus 2.3% in pediatric patients). In this analysis, the incidence of serious bleeding events for topiramate and placebo was 0.3% versus 0.2% for adult patients, and 0.4% versus 0% for pediatric patients. Adverse bleeding reactions reported with topiramate ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants). Other Adverse Reactions Observed During Clinical Trials Other adverse reactions seen during clinical trials were: abnormal coordination, eosinophilia, gingival bleeding, hematuria, hypotension, myalgia, myopia, postural hypotension, scotoma, suicide attempt, syncope, and visual field defect. Laboratory Test Abnormalities Adult Patients-In addition to changes in serum bicarbonate (i.e., metabolic acidosis), sodium chloride and ammonia, immediate-release topiramate was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebocontrolled studies. Pediatric Patients-In pediatric patients (ranging from 6-17 years old) receiving immediate-release topiramate for migraine prophylaxis, there was an increased incidence for an increased result (relative to normal analyte reference range) associated with immediate-release topiramate (vs placebo) for the following clinical laboratory analytes: creatinine, BUN, uric acid, chloride, ammonia, alkaline phosphatase, total protein, platelets, and eosinophils. The incidence was also increased for a decreased result for phosphorus, bicarbonate, total white blood count, and neutrophils. TROKENDI XR is not indicated for prophylaxis of migraine headache in pediatric patients less than 12 years of age. Postmarketing Experience The following adverse reactions have been identified during post-approval use of immediate-release topiramate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole-General Disorders: oligohydrosis and hyperthermia, hyperammonemia, hyperammonemic encephalopathy, hypothermia with concomitant valproic acid Gastrointestinal System Disorders: hepatic failure (including fatalities), hepatitis, pancreatitis Skin and Appendage Disorders: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), pemphigus Urinary System Disorders: kidney stones Vision disorders: acute myopia, secondary angle closure glaucoma, maculopathy
Because of the potential of topiramate to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, TROKENDI XR should be used with extreme caution if used in combination with alcohol and other CNS depressants. Oral Contraceptives The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur in patients taking combination oral contraceptive products with TROKENDI XR. Patients taking estrogen-containing contraceptives should be asked to report any change in their bleeding patterns. Contraceptive efficacy can be decreased even in the absence of breakthrough bleeding. Hydrochlorothiazide (HCTZ) Topiramate Cmax and AUC increased when HCTZ was added to immediate-release topiramate. The clinical significance of this change is unknown. The addition of HCTZ to TROKENDI XR may require a decrease in the TROKENDI XR dose. Pioglitazone A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and immediate-release topiramate in a clinical trial. The clinical relevance of these observations is unknown; however, when TROKENDI XR is added to pioglitazone therapy or pioglitazone is added to TROKENDI XR therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state. Lithium An increase in systemic exposure of lithium following topiramate doses of up to 600 mg/day can occur. Lithium levels should be monitored when co-administered with high-dose TROKENDI XR. Amitriptyline Some patients may experience a large increase in amitriptyline concentration in the presence of TROKENDI XR and any adjustments in amitriptyline dose should be made according to the patients’ clinical response and not on the basis of plasma levels.
USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Exposure Registry-There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334. Information about the North American Drug Pregnancy Registry can be found at http://www.aedpregnancyregistry.org/. Risk Summary-Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have increased risk for cleft lip and/or cleft palate (oral clefts) and for being small for gestational age [see Human Data]. In multiple animal species, topiramate demonstrated developmental toxicity, including teratogenicity, in the absence of maternal toxicity at clinically relevant doses [see Animal Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations-Fetal/ Neonatal Adverse Reactions-Consider the benefits and risks of topiramate when prescribing this drug to women of childbearing potential, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. Because of the risk of oral clefts to the fetus, which occur in the first trimester of pregnancy before many women know they are pregnant, all women of childbearing potential should be informed of the potential risk to the fetus from exposure to topiramate. Women who are planning a pregnancy should be counseled regarding the relative risks and benefits of topiramate use during pregnancy, and alternative therapeutic options should be considered for these patients. Labor or Delivery-Although the effect of topiramate on labor and delivery in humans has not been established, the development of topiramate-induced metabolic acidosis in the mother and/or in the fetus might affect the fetus’ ability to tolerate labor. TROKENDI XR treatment can cause metabolic acidosis. The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus’ ability to tolerate labor. Pregnant patients should be monitored for metabolic acidosis and treated as in the nonpregnant state. Newborns of mothers treated with TROKENDI XR should be monitored for metabolic acidosis because of transfer of topiramate to the fetus and possible occurrence of transient metabolic acidosis following birth. Data-Human Data-Data from pregnancy registries indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. In the NAAED pregnancy registry, the prevalence of oral clefts among topiramate-exposed infants (1.1%) was higher than the prevalence of infants exposed to reference AEDs (0.36%), or the prevalence in infants of mothers without epilepsy and without exposure to AEDs (0.12%). It was also higher than the background prevalence in United States (0.17%) as estimated by the Centers for Disease Control and Prevention (CDC). The relative risk of oral clefts in topiramateexposed pregnancies in the NAAED Pregnancy Registry was 9.6 (95% DRUG INTERACTIONS Confidence Interval=[CI] 4.0-23.0) as compared to the risk in a Alcohol Alcohol use is contraindicated within 6 hours prior to and 6 hours background population of untreated women. The UK Epilepsy and after TROKENDI XR administration. Antiepileptic Drugs Concomitant Pregnancy Register reported a prevalence of oral clefts among infants administration of phenytoin or carbamazepine with topiramate resulted in exposed to topiramate monotherapy (3.2%) that was 16 times higher than a clinically significant decrease in plasma concentrations of topiramate the background rate in the UK (0.2%). Data from the NAAED pregnancy when compared to topiramate given alone. A dosage adjustment may be registry and a population-based birth registry cohort indicate that needed. Concomitant administration of valproic acid and topiramate has exposure to topiramate in utero is associated with an increased risk of been associated with hypothermia and hyperammonemia with and small for gestational age (SGA) newborns (birth weight <10th percentile). without encephalopathy. Examine blood ammonia levels in patients in In the NAAED pregnancy registry, 18% of topiramate-exposed newborns whom the onset of hypothermia has been reported. Other Carbonic were SGA compared to 7% of newborns exposed to a reference AED, and Anhydrase Inhibitors Concomitant use of topiramate, a carbonic 5% of newborns of mothers without epilepsy and without AED exposure. anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., In the Medical Birth Registry of Norway (MBRN), a population-based zonisamide, acetazolamide, or dichlorphenamide), may increase the pregnancy registry, 25% of newborns in the topiramate monotherapy severity of metabolic acidosis and may also increase the risk of kidney exposure group were SGA compared to 9% in the comparison group who stone formation. Patients should be monitored for the appearance or were unexposed to AEDs. The long-term consequences of the SGA findings worsening of metabolic acidosis when TROKENDI XR is given are not known. Lactation Risk Summary-Topiramate is excreted in human concomitantly with another carbonic anhydrase inhibitor. CNS milk [see Data]. The effects of topiramate exposure in breastfed infants or Depressants Concomitant administration of topiramate with other CNS on milk production are unknown. The developmental and health benefits depressant drugs or alcohol has not been evaluated in clinical studies. of breastfeeding should be considered along with the mother’s clinical
need for TROKENDI XR and any potential adverse effects on the breastfed infant from TROKENDI XR or from the underlying maternal condition. Data-Limited data from 5 women with epilepsy treated with topiramate during lactation showed drug levels in milk similar to those in maternal plasma. Females and Males of Reproductive Potential ContraceptionWomen of childbearing potential who are not planning a pregnancy should use effective contraception because of the risks to the fetus of oral clefts and of being small for gestational age. Pediatric Use Because the capsule must be swallowed whole, and may not be sprinkled on food, crushed, or chewed, TROKENDI XR is recommended only for children age 6 or older. Migraine Prophylaxis in Pediatric Patients 12 to 17 Years of Age-Safety and effectiveness of topiramate in the prophylaxis of migraine was studied in 5 double-blind, randomized, placebo-controlled, parallel-group trials in a total of 219 pediatric patients, at doses of 50 mg/day to 200 mg/day, or 2 to 3 mg/kg/day. These comprised a fixed dose study in 103 pediatric patients 12 to 17 years of age, a flexible dose (2 to 3 mg/kg/day), placebo-controlled study in 157 pediatric patients 6 to 16 years of age (including 67 pediatric patients 12 to 16 years of age), and a total of 49 pediatric patients 12 to 17 years of age in 3 studies of migraine prophylaxis primarily in adults. Open-label extension phases of 3 studies enabled evaluation of long-term safety for up to 6 months after the end of the double-blind phase. Efficacy of topiramate (2 to 3 mg/kg/ day) for migraine prophylaxis was not demonstrated in a placebocontrolled trial of 157 pediatric patients (6 to 16 years of age) that included treatment of 67 pediatric patients (12 to 16 years of age) for 20 weeks. In the pediatric trials (12 to 17 years of age) in which patients were randomized to placebo or a fixed daily dose of immediate-release topiramate, the most common adverse reactions with immediate-release topiramate that were seen at an incidence higher (>5%) than in the placebo group were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain. The most common cognitive adverse reaction in pooled double-blind studies in pediatric patients 12 to 17 years of age was difficulty with concentration/attention. Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated pediatric migraine patients. In topiramate-treated pediatric patients (12 to 17 years of age) compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate. Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse that were observed occurred more commonly in pediatric patients treated with topiramate compared to pediatric patients treated with placebo. Migraine Prophylaxis in Pediatric Patients 6 to 11 Years of Age-Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the prophylaxis treatment of migraine headache. In a double-blind study in 90 pediatric patients 6 to 11 years of age (including 59 topiramatetreated and 31 placebo patients), the adverse reaction profile was generally similar to that seen in pooled double-blind studies of pediatric patients 12 to 17 years of age. The most common adverse reactions that occurred in immediate-release topiramate-treated pediatric patients 6 to 11 years of age, and at least twice as frequently than placebo, were gastroenteritis (12% topiramate, 6% placebo), sinusitis (10% topiramate, 3% placebo), weight loss (8% topiramate, 3% placebo) and paresthesia (7% topiramate, 0% placebo). Difficulty with concentration/ attention occurred in 3 topiramate-treated patients (5%) and 0 placebo-treated patients. The risk for cognitive adverse reactions was greater in younger patients (6 to 11 years of age) than in older patients (12 to 17 years of age). Geriatric Use Clinical studies of immediaterelease topiramate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Dosage adjustment may be necessary for elderly with creatinine clearance less than 70 mL/min/1.73 m2. Estimate GFR should be measured prior to dosing. Renal Impairment The clearance of topiramate is reduced in patients with moderate (creatinine clearance 30 to 69 mL/min/1.73m2) and severe (creatinine clearance less than 30 mL/ min/1.73m2) renal impairment. A dosage adjustment is recommended in patients with moderate or severe renal impairment. Patients Undergoing Hemodialysis Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than in a normal individual. A dosage adjustment may be required. OVERDOSAGE Overdoses of topiramate have been reported. Signs and symptoms included convulsions, drowsiness, speech disturbance, blurred vision, diplopia, impaired mentation, lethargy, abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness, and depression. The clinical consequences were not severe in most cases, but deaths have been reported after overdoses involving topiramate. Topiramate overdose has resulted in severe metabolic acidosis. A patient who ingested a dose of immediate-release topiramate between 96 g and 110 g was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. Similar signs, symptoms, and clinical consequences are expected to occur with overdosage of TROKENDI XR. Therefore, in acute TROKENDI XR overdose, if the ingestion is recent, the stomach should be emptied immediately by lavage or by induction of emesis. Activated charcoal has been shown to absorb topiramate in vitro. Hemodialysis is an effective means of removing topiramate from the body. Pharmacokinetics Specific Populations-Hepatic Impairment-Plasma clearance of topiramate decreased a mean of 26% in patients with moderate to severe hepatic impairment. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, Maryland 20850 RA-TRO-BS-HCP-V3 Revised: June 2018 Based on PI Jan 2018
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XR FIRST ®
FOR MIGRAINE PREVENTION1 INDICATION Trokendi XR (topiramate) extended-release capsules are indicated for prophylaxis of migraine headaches in patients 12 years of age and older. CONTRAINDICATIONS Trokendi XR is contraindicated in patients with recent alcohol use (within 6 hours prior to and 6 hours after Trokendi XR use). Please refer to the brief summary of full Prescribing Information on adjacent pages, or visit www.TrokendiXR.com.
Trokendi XR is a registered trademark of Supernus Pharmaceuticals, Inc. ©2019 Supernus Pharmaceuticals, Inc. All rights reserved. SPN.TRO.2019-0037
Capsules shown are not actual size.
FIRST FOR MIGRAINE PREVENTION
REFERENCE: 1. Trokendi XR [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; January 2018.