Texas Family Physician, Q4 2017

TEXAS FAMILY PHYSICIAN VOL. 68 NO. 4 2017

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INSIDE

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TEXAS FAMILY PHYSICIAN VOL. 68 NO. 4 2017

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Confronting physician burnout

Physician health and well-being have been top of mind at national and state family medicine conventions this year. Your Academy has your back. Here are some resources you can use.

22

Introducing AAFP’s Physician Health First initiative

At this year’s FMX, AAFP launched a comprehensive set of tools and resources to help physicians avoid occupational burnout.

By Sheri Porter

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“How I bounced back from burnout” Get a fresh perspective from a young family doc on staying healthy.

By Kimberly Becher, MD

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Watch some free well-being CME videos Feeling burnt out? Yep. There’s CME for that.

By Chris Crawford

6 FROM YOUR PRESIDENT On the shoulders of giants 10 MEMBER NEWS Swegler wins board seat at AAFP Congress of Delegates | Sheets, Chenven, Seto win awards at AAFP Congress | Botsford named AAFP commission chair 10 ASPCS REPORT Photos and news from Galveston conference 14 PUBLIC HEALTH Addressing Texas’ maternal mortality crisis 16 MED ED Maybe U.S. schools should look abroad for new ideas.

38 PERSPECTIVE An Oregon tale

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PRESIDENT’S COLUMN

TEXAS FAMILY PHYSICIAN VOL. 68 NO. 4 2017

The Texas Academy of Family Physicians is the premier membership organization dedicated to uniting the family doctors of Texas through advocacy, education, and member services, and empowering them to provide a medical home for patients of all ages. TEXAS FAMILY PHYSICIAN is published quarterly by TAFP at 12012 Technology Blvd., Ste. 200, Austin, Texas 78727. Contact TFP at (512) 329-8666 or jnelson@tafp.org.

On the shoulders of giants An excerpt from the inaugural speech of the new TAFP President

By Janet Hurley, MD TAFP President

OFFICERS president

Janet Hurley, MD

president-elect vice president treasurer

Rebecca Hart, MD

Amer Shakil, MD, MBA

Javier “Jake” Margo, Jr., MD

parliamentarian

Mary Nguyen, MD

immediate past president

Tricia Elliott, MD

EDITORIAL STAFF managing editor

Jonathan L. Nelson

associate editors

Perdita Henry and Jean Klewitz chief executive officer and executive vice president

Tom Banning chief operating officer

Kathy McCarthy, CAE

advertising sales associate

Michael Conwell CONTRIBUTING EDITORS Kimberly Becher, MD Travis Bias, DO, MPH, DTM&H Chris Crawford Sheri Porter Janet Realini, MD, MPH Jim Rickards, MD, MBA

SUBSCRIPTIONS To subscribe to TEXAS FAMILY PHYSICIAN, write to TAFP Department of Communications, 12012 Technology Blvd., Ste. 200, Austin, Texas 78727. Subscriptions are $20 per year.

Articles published in TEXAS FAMILY PHYSICIAN represent the opinions of the authors and do not necessarily reflect the policy or views of the Texas Academy of Family Physicians. The editors reserve the right to review and to accept or reject commentary and advertising deemed inappropriate. Publica­tion of an advertisement is not to be considered an endorsement by the Texas Academy of Family Physicians of the product or service involved. TEXAS FAMILY PHYSICIAN is printed by AIM Printing and Marketing, Austin, Texas.

LEGISLATIVE ADVERTISING Articles in TEXAS FAMILY PHYSICIAN that mention TAFP’s position on state legislation are defined as “legislative advertising,” according to Texas Govt. Code Ann. §305.027.

The person who contracts with the printer to publish the legislative advertising is Tom Banning, CEO, TAFP, 12012 Technology Blvd., Ste. 200, Austin, Texas 78727. © 2017 Texas Academy of Family Physicians POSTMASTER Send address changes to TEXAS FAMILY PHYSICIAN, 12012 Technology Blvd., Ste. 200, Austin, TX 78727.

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TEXAS FAMILY PHYSICIAN [No. 4] 2017

greetings friends, colleagues, staff, and family members. It is my honor to stand before you as our next TAFP President. As I watched Dr. Elliott receive this medallion last year, I thought of all of the leaders in the past who have worn this medallion before us. I am honored to receive the responsibility today, acknowledging that this medallion has been around the necks of many giants along the way before me.

My first TAFP meeting was in the summer of 1997, ironically also here in Galveston. I was a student, wandering lost around the conference hotel. I was impressed to feel so welcomed by the TAFP staff and physician leaders, like Dr. David Schneider, who was among my first Academy mentors.

I was surprised to see their passion for family medicine. This was a far cry from the family medicine I saw in medical school. As I continued to absorb the content of the meetings, I recognized that these physician leaders were a special bunch of people. Though I did not know any of them then, I later came to recognize them as the giants they truly are.

Leah Ray Mabry was the TAFP president that year, making a bit of a stir as only the second female president of the Academy. Under her wings was an up-andcoming leader named Lloyd Van Winkle, and right ahead of her were Roland Goertz and Jim Martin.

As I heard these leaders speak in various venues, I was impressed that they cared not only about their practice or their patients, but they also cared about the health of their communities, their state, and their nation.

They seemed driven by a call to influence health care policy both in the legislative and private arenas to create positive changes for their patients back home and throughout their state. This was a call much bigger than I had ever seen and these were people who were passionate, articulate, and genuine. They inspired me to look beyond myself toward what can be accomplished when passionate physicians organize to do big things.

They didn’t know me at all then but their inspiration captivated me.

Through the years, I watched these leaders move up to AAFP positions. I recall Dr. Martin in attendance at the AAFP National Conference of Family Medicine Residents and Students, speaking about the Future of Family Medicine Project. As he addressed that large crowd of young people, his passion was obvious and his delivery genuine. He was the kind of leader I hoped to be someday.

I met others along the way that helped keep me focused on the greatness of family medicine, such as Dr. C.H. Prihoda from Navasota, Texas. Dr. Prihoda served as my family medicine preceptor in the summer between my first and second years of medical school when I was participating in the

I believe that family medicine’s time for resurgence is now. The giants who wore this medallion before me set the stage for what we can become.

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Texas Family Medicine Preceptorship Program. This experience gave me a window into how family medicine truly shines in the community it serves, adapting to meet the needs of our neighbors.

Later in my third year of medical school, I had several attendings who tried to talk me out of family medicine, saying things about family medicine that simply weren’t true. In those times I set my mind back to Dr. Prihoda’s clinic. When I heard these mistruths, I was able to tell myself, “Oh no, no, no, this is not the family medicine I know.”

Thank you, Dr. Prihoda, for opening your practice to me so many years ago.

Through the years I grew in my knowledge and commitment. I found myself asking questions and offering the student and resident perspective when it seemed relevant. I learned how to run a meeting and learned about parliamentary procedure. I developed life-long friendships, and became a champion for my specialty.

I believe that family medicine’s time for resurgence is now. The giants who wore this medallion before me set the stage for what we can become.

Now what are we going to do with it?

Do you believe as I do that family medicine is this nation’s best hope for a sustainable, practical, and financially sound health care system? Do you believe as I do that we are positioned well as a specialty to finally be valued for the work we do? Are you ready to transform your practices into something better than they had been, to do your part to make this health care system the best that it can be? If the answer is yes, then we must continue to act.

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JONATHAN NELSON

COMING SOON ON TAFP’S

CME SCHEDULE C. Frank Webber Lectureship & Interim Session April 13-14, 2018 Renaissance Austin Hotel Austin, Texas Texas Family Medicine Symposium June 8-10, 2018 La Cantera Hill Country Resort & Spa San Antonio, Texas Annual Session & Primary Care Summit Nov. 9-11, 2018 Nov. 7-8: Business meetings and preconference workshops

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TEXAS FAMILY PHYSICIAN [No. 4] 2017

From left: AAFP Immediate Past Board Chair Wanda Filer, MD, administers the oath of office to incoming TAFP President Janet Hurley, MD.

[cont. from 7]

done behind the scenes to prepare us well for system, and my leadership plays at least some next year. I will collaborate with TAFP staff tiny role in supporting that, then I hope we to work on those things that matter most to can agree that these efforts are worth it. family medicine and our My question to you patients. is simply this: is it worth TAFP will continue it to you? Is leadership Do you believe as I do to train the next group in family medicine of leaders through our worth your time? Do that family medicine leadership college, the you believe as I do that is this nation’s Family Medicine Leaderfamily medicine is best hope for a ship Experience, and America’s best hope for a sustainable health care sustainable, practical, other venues with the system? Do you believe and financially sound goal to empower family physicians to lead locally as I do that family medihealth care system? in their clinics, health cine is the primary care systems, communities, specialty most adaptable Do you believe as and hospital board rooms. to the individual needs I do that we are With those new of different communipositioned well as a skills comes a renewed ties? Do you believe as I commitment to embracdo that family medicine’s specialty to finally be ing who we are, and time for resurgence is valued for the work proclaiming our value now?” If you do believe we do?

If the answer with boldness locally to it, what are you going to administrators, spedo about it? is yes, then we must cialists, students, and I have heard our continue to act. legislators. Remember CEO, Tom Banning, say the old saw: “All politics “Politics is the art of the are local.” Let us never possible.” Sometimes we doubt the influence we can have locally. find that more things are possible by moving I humbly accept this medallion today. As outside of the Texas Legislature and appealI do so, I remember those giants who have ing directly to employers, integrated health worn it before me. Thank you for this opporcare groups, and insurers. While this is not tunity to serve as your TAFP President. a legislative year, there is much work to be

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TEXAS FAMILY PHYSICIAN [No. 4] 2017

congratulations to Erica Swegler, MD, of Austin, Texas, who won her bid to serve a three-year term on the Board of Directors of the American Academy of Family Physicians.

The election was held on Sept. 13, 2017, at the annual meeting of the AAFP Congress of Delegates in San Antonio. The board of directors advocate on behalf of family physicians and patients nationwide to inspire positive change in the U.S. health care system, according to an AAFP statement.

“I believe in family medicine,” she said in a statement announcing her candidacy. “In our specialty lies the solution for what ails our nation’s inefficient and expensive health care system. I am determined to help effect that solution in my practice, my community, our organization, and within the halls of government.”

Dr. Swegler has practiced medicine for more than 30 years. Her meritorious career includes stints in rural communities as well

as metropolitan practices. Currently she owns Beacon Family Health Care, where she cares for patients in the Austin community.

She is a past president of the Texas Academy of Family Physicians and a past recipient of the Texas Family Physician of the Year Award. She represented Texas in the AAFP Congress of Delegates for 10 years and she has served on three AAFP Commissions: Governmental Advocacy, Quality, and Health Care Services. She has also served in a variety of capacities with the Texas Medical Association, as well as on the Texas Council on Cardiovascular Disease and Stroke, and the American Heart Association’s Medical and Scientific Advisory Committee for Texas.

She received her medical degree from the University of Texas Medical School at Houston and completed her family medicine residency at University of Texas Southwestern Medical School.

PHOTOS: JONATHAN NELSON

TAFP members shine bright at AAFP Congress of Delegates

Seto receives Award for Excellence in Graduate Medical Education

H. Kyle Sheets, MD, addresses the AAFP Congress of Delegates.

Norman Chenven, MD, (left) accepts his award from AAFP Board Chair John Meigs, Jr., MD.

Sheets receives AAFP’s Humanitarian Award

Chenven receives Robert Graham Family Physician Executive Award

h. kyle sheets, md, founder and CEO of Concord Medical Group in Lubbock, received the 2017 Humanitarian Award during AAFP’s annual meeting. The Humanitarian Award honors extraordinary and enduring humanitarian efforts by AAFP members, both within and beyond the borders of the United States, according to an AAFP statement.

During his third year of residency, Sheets, his wife, and their 10 children took a trip to Zimbabwe where he completed a one-month rotation at the Karanda Mission Hospital. The rotation set him and his family on a new path.

“I never wanted to do medical missions,” Sheets said as he accepted the award. “It seemed too difficult, too expensive, and way too scary. But in 1999 when we went to Zimbabwe, I thought it would be a great medical experience, I thought it would be a good education for my children, and I thought it would be a great spiritual experience. ... I was not prepared to fall in love with the Shona people of Africa. I was not prepared for the life-changing experience that we encountered there.”

Four years after that first mission trip, Sheets founded PAPA Missions — Physicians Aiding Physicians Abroad — to provide training to other physicians with no practical experience planning mission trips. The organization now focuses on sending supplies and volunteers to those in need. Through PAPA, Hundreds of volunteers have provided care in six countries and medical supplies have been shipped to communities around the world, according to an AAFP statement.

norman chenven, md, of Austin, received the 2017 Robert Graham Family Physician Executive Award during AAFP’s annual meeting. AAFP President John Meigs, Jr., MD, presented the award to Chenven “for using his executive skills to improve access to high-quality health care and to foster the tenants of family medicine.”

Chenven is the founding CEO of Austin Regional Clinic, one of the largest multispecialty medical groups in the state, which delivers care to more than 400,000 patients. He also serves as the president and CEO of Covenant Management Systems, which provides technical support and services to governmental and employer-based health plans.

“These are really the best of times and the worst of times,” Chenven said as he accepted the award. “Best because medical science has given us an amazing array of treatments and capabilities to treat disease and relieve suffering for our patients. It’s the worst of times because we are hampered by a very broken business model. ... What I do know is that in the meantime, the best hope for future improvements will come from physician leadership and in particular, from primary care.”

Chenven has served as a board member on major medical organizations including the American Medical Group Association, the Council of Accountable Physician Practices, and CAPG, the Voice of Accountable Physician Groups. He has served on national advisory boards for many major health plans including United, Blue Cross Blue Shield, Aetna, and Cigna. Last year, he was named TAFP Physician Emeritus.

edward seto, md, of San Antonio, was selected to receive AAFP’s 2017 Award for Excellence in Graduate Medical Education.

The awarded is only given to 12 family medicine residents each year out of the 3,500 eligible for the honor. Seto is co-chief at Christus Santa Rosa Family Medicine Residency Program and was recently named a TAFP Member of the Month.

Botsford named chair of AAFP commission lindsay botsford, md, of Houston, was named chair of the Commission on Quality and Practice during AAFP’s Family Medicine Experience. She has several years of experience serving with AAFP in multiple roles over the span of her career and she helped TAFP create its own yearlong leadership development program, the Family Medicine Leadership Experience.

Congratulations to all honored, elected, and nominated during this year’s AAFP Congress of Delegates!

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11

Report from the TAFP 2017 Annual Session and Primary Care Summit in Galveston

By Perdita Henry

family physicians and other health professionals from around the state gathered in Galveston, Nov. 10-12, for TAFP’s Annual Session and Primary Care Summit. A total of 466 registrants gathered to network, earn CME, shape TAFP policy at committee and commission meetings, and celebrate the specialty of family medicine.

Attendees had opportunities to learn about a variety of topics during the scientific portion of the conference and earn up to 21 AMA PRA Category 1 Credits™. Participants could attend three Knowledge SelfAssessment Module workshops Wednesday, 12

TEXAS FAMILY PHYSICIAN [No. 4] 2017

Friday, and Sunday, on Preventive Care, Coronary Artery Disease, and Maternity Care. The National Procedures Institute offered their popular Joint Exam and Injections course and the Sideline Management Assessment Response Technique course.

The TAFP Foundation held an exclusive seafood dinner at Galveston’s famed Fisherman’s Wharf with proceeds going to benefit the TAFP Foundation Research Endowment. Thank you to AbbVie for being a Platinum Level sponsor; Texas Medical Association, Texas Medical Liability Trust, Catalyst Health Network, and Robert

PHOTOS: JONATHAN NELSON

TO THE BEACH AND BACK

Youens, MD, for being Gold Level sponsors.

Thank you also to Texas Organization of Rural and Community Hospitals and Baylor Scott & White Health for being Silver Level sponsors; and to Kelsey Seybold Clinic and Austin Regional Clinic for being Bronze Level sponsors.

The CME general session opened with special keynote speaker and ebola survivor, Kent Brantly, MD, delivering a lecture on what happens “When the Physician Becomes the Patient.” The rest of the weekend’s CME included topics on influenza in older adults, infectious disease, an ethics talk on palliative care, a lecture on the prevention of hepatitis, and much more. AAFP’s immediate past board chair, Wanda Filer, MD, of Pennsylvania provided an update on the national academy on Sunday morning.

Rebecca Hart, MD, gave a TAFP update during Friday’s Member Assembly Luncheon. Delegates from TAFP’s local chapters elected Terrance Hines, MD, to serve as at-large director, Lawrence Gibbs, MD, to serve as new physician director, and Mary Nguyen, MD, to serve as parliamentarian.

Clockwise from left: Dale Moquist, MD, accepts the 2017 Physician Emeritus Award.

TAFP President Tricia Elliott, MD, presents Marcy Wiemers, MD, with the Full-time Faculty Exemplary Teaching Award.

Physician of the Year, Jorge Duchicela, MD, accepts his award from TAFP President Tricia Elliott, MD. Joy Emko, MD, speaks after being presented the Part-time Faculty Exemplary Teaching Award.

Barbara Thompson, MD, is presented with the Presidential Award of Merit.

TAFP’s 2017 award recipients and new officers Saturday’s Annual Business and Awards Lunch began with members present voting to adopt the TAFP bylaws changes. Next, TAFP’s top honors were announced. Here’s a list of this year’s winners.

Physician of the Year: Jorge Duchicela, MD Originally from Guayaquil, Ecuador, Jorge Duchicela, MD, immigrated to the Wisconsin at the age of 13. He would later earn his Bachelor of Science and his medical degree from the University of Wisconsin. He completed his family medicine residency at the University of Texas Medical Branch at Galveston in both surgery and family medicine. In 1990, he moved to Weimar with his wife, Juanita, and their three children, Keegan, Ima, and Dezbah, and became a partner in the Youens & Duchicela Clinic.

Duchicela is the past chief of medical staff at Columbus Community Hospital, founder and president of Texas Rural Family

Medicine Education Center, and founder and director of Cachamsi, a nonprofit medical immersion institute that teaches health professionals Spanish and global and cross-cultural medicine. He served as board director of the Colorado Valley Chapter of TAFP for 10 years, currently serves as chair of TAFP’s of the Commission on Legislative and Public Affairs, and is the chair of the Conference Committee on Practice Improvement of the Society of Teachers of Family Medicine.

After accepting the award, Duchicela reflected on the journey that lead him to this moment. “I came to Weimar a welltrained family physician. There I discovered the training had just begun. I am thankful to all those patients who trusted me and had the patience to teach me how to become a better family physician.”

In addition to his numerous medical positions, he is a founder, director, and contributor to several non-profit educational assistance organizations serving youth and adults in the Weimar area. He has been instrumental in the foundation of an area

soccer league and the establishment of a permanent practice and game facility.

Physician Emeritus: Dale C. Moquist, MD Dale Moquist, MD, received his Bachelor in Science from the University of North Dakota, his medical degree from the University of Texas at Dallas, and completed his residency at the University of Minnesota Family Practice Residency Program. He moved to Texas after a long career in North Dakota, during which he was active in the North Dakota Academy of Family of Physicians and served on the AAFP Board of Directors.

After becoming a Texas resident, he generously shared his vast leadership experience with his new colleagues and assisted TAFP with campaigns to elect AAFP leaders. He is a former faculty member of the Memorial Family Practice Residency Program. He served as director for the Wichita Falls Family Practice Residency Program, and as faculty at the Family Practice Residency Program of the Brazos Valley. He was a part of AAFP’s delegation to the American Medical Associawww.tafp.org

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Above: AAFP Immediate Past Board Chair Wanda Filer, MD, receives her traditional hi-roller hat from newly inducted TAFP President, Janet Hurley, MD.

Above: Seth Cowan, MD, receives the Philanthropist of the Year Award from the president of the TAFP Foundation, Linda Siy, MD.

Below: Linda Siy, MD, receives the TAFPPAC Award.

Below: Scott Lillibridge, MD, accepts the Public Health Award.

Presidential Award of Merit: Barbara Thompson, MD Barbara Thompson, MD, is a family physician professor at the University of Texas Medical Branch at Galveston and currently holds the Sealy Hutchings and Lucille Wright Hutchings Chair. She is also the current chair of the department of family medicine, a position she’s held for 20 years.

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TEXAS FAMILY PHYSICIAN [No. 4] 2017

She has spent more than 40 years caring for her patients, advocating for the specialty of family medicine, and teaching students and residents. Thompson received numerous honors and awards for her work as a professor and physician. She’s a recipient of the John P. McGovern Award and Endowment, she’s been recognized eight times as a Texas Super Doctor by Texas Monthly Magazine, and she was recognized by the UTMB School of Medicine Alumni Association with the Ashbel Smith Distinguished Alumnus Award for her outstanding service to the medical profession and humanity.

Patient Advocacy Award: Dan Hinkle Dan Hinkle has more than 30 years of government affairs experience and an extensive background in both engineering and legal fields. He reflected on what the award

significance in his recorded acceptance speech. “This award is special to me. I grew up in the second least-populated-county in the state of Missouri,” Hinkle said. “We were lucky we had a family physician in our town because the nearest hospital was nearly 50 miles away. It has been a great privilege and honor to represent the Texas Academy of Family Physicians.”

Public Health Award: Scott Lillibridge, MD Scott Lillibridge, MD, has more than 30 years of experience in medical and public health preparedness in domestic and international settings. He is the founding director of the CDC Bioterrorism Preparedness and Response Program and served as special assistant to the Secretary of the Department of Health and Human Services during the 2001 anthrax attacks.

PHOTOS: JONATHAN NELSON

tion and served as chair of the delegation for many years. He served as president of the TAFP Foundation for 10 years and enthusiastically supported the Foundation’s mission to encourage medical students to pursue the specialty, to support family medicine residents, and to fund practice-based primary care research. Under his leadership, the TAFP Foundation created several new medical student scholarships and began its research endowment. He is currently retired.

Left: Emily Briggs, MD, enjoys the Mardi-Gras-themed President’s Party.

Right: Newly inducted TAFP President, Janet Hurley, MD, gives her presidential address.

He has also contributed to several state and local public health policy forums, and has helped bring clinical trials to South Texas to ensure the population has access to new investigative drugs. He assisted in the development of the Global Institute for Hispanic Health in Corpus Christi, he brought the first CDC funded Public Health Preparedness Center to Texas, and he served on the Governor’s Task Force for Emerging Infectious Disease.

Full-time Faculty Exemplary Teaching Award: Marcy Wiemers, MD Marcy Wiemers, MD, is the full-time family medicine residency associate program director and is an assistant clinical professor at UT Health San Antonio. She has received several recognitions and awards for her work as a professor, physician, and scholar, including the Corpus Christi Family

Medicine Residency Program’s Family Medicine Faculty Teaching Award in both 2008 and 2012 and UT Health San Antonio’s Family and Community Medicine Education Development Award.

Part-time Faculty Exemplary Teaching Award: Nida Joy Emko, MD Nida Joy Emko, MD, is a part-time clinical associate professor in the Department of Family and Community Medicine at UT Health San Antonio. She also cares for incarcerated teens at the Bexar County Juvenile Detention Center, teaches family medicine residents at the Family Health Center at UT Health San Antonio, and sees patients at the Family Medicine Inpatient Service at University Hospital. She’s received numerous honors and awards for her work as a professor, physician, and scholar, including the Leonard Tow Humanism in Medicine Award

for Faculty, and the Veritas Faculty Mentor of the Year Award, and she has been named among the Best Doctors in San Antonio by Scene Magazine.

Special Constituency Leadership Award: Emily Briggs, MD, MPH Emily Briggs, MD, MPH, is the founder of Briggs Family Medicine in New Braunfels, where she practices full-spectrum family medicine and obstetrics and is the medical director for two school districts. She is an active TAFP member who has served on multiple committees and commissions and as the new physician board member for both TAFP and AAFP. She has served as president of her local chapter of the Texas Medical Association and the Alamo Chapter of TAFP. She has also represented Texas during AAFP’s National Conference of Constituency Leaders. www.tafp.org

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JONATHAN NELSON

TAFP’s 2017-2018 officers from left: Parliamentarian Mary Nguyen, MD; Vice President Amer Shakil, MD; Immediate Past President Tricia C. Elliott, MD; President Janet Hurley, MD; Treasurer Javier “Jake” Margo Jr., MD; President-elect Rebecca Hart, MD.

TAFP Foundation Philanthropist of the Year: Seth Cowan, MD Seth Cowan, MD, was president of TAFP from 1979-1980. He is responsible for several leadership development programs and mentored several generations of TAFP leaders. He was named Texas Family Physician of the Year in 1989 in recognition of his years of service, leadership, and excellence. He is a founding member of the Family Clinic of Garland. Throughout his career, he has been a leader in organized medicine on all levels, becoming a member of TAFP and AAFP in 1958. He served as TAFP Foundation president, oversaw the development of the scholarship program, and has served on numerous committees and commissions for both TAFP and AAFP. He served on the TAFP Foundation’s Board of Trustees for close to 36 years including seven years as treasurer and is a monthly donor who reached the fifth level of the organization’s monthly donor program in 2015. In 2017 he made a generous donation to endow a scholarship in his name to ben16

TEXAS FAMILY PHYSICIAN [No. 4] 2017

efit a family medicine resident in training at the Baylor Family Medicine Residency at Garland.

TAFP Political Action Committee Award: Linda Siy, MD Linda Siy, MD, served as president of TAFP from 2007-2008 and went on to represent Texas in AAFP’s Congress of Delegates serving as alternate delegate and now delegate. As delegate, she passionately advocated this year for AAFP to assist state chapters with political action committees in collecting support through the annual dues billing process. She is a longtime advocate for family medicine, working to develop local relationships with her elected officials and is regarded as an expert in health policy.

She’s served as chair of the TAFP Political Action Committee Board of Trustees.

TAFP Officer Installation Following the presentation of awards, Dr. Filer installed the TAFP 2017-2018 officers. They are President Janet Hurley,

MD; President-elect Rebecca Hart, MD; Vice President Amer Shakil, MD, MBA; Treasurer Javier “Jake” Margo, Jr., MD; and Parliamentarian Mary Nguyen, MD. In her inaugural address, Hurley thanked the many physician leaders who have gone before her and several mentors who have guided her along her path. She encouraged family physicians to become involved in the Academy for the sake of the specialty, their patients, and their own fulfillment.

“I believe that family medicine’s time for resurgence is now. The giants who wore this medallion before me set the stage for what we can become,” she told the audience.

Mark your calendars now for upcoming symposia. The 2017 C. Frank Webber Lectureship will be held April 13-14 at the Renaissance Austin Hotel. The Texas Family Medicine Symposium will be June 8-10, 2017 at La Cantera Hill Country Resort and Spa in San Antonio, and next year’s Annual Session and Primary Care Summit will be Nov 9-11, 2018 in Arlington. For the full 2018 schedule, visit www.tafp.org/professional-development.

PUBLIC HEALTH

Addressing Texas’ maternal mortality crisis Janet Realini, MD, MPH

A

s is often the case in Texas politics, there was little agreement during the 85th Legislative Session on which steps are necessary to address the state’s many health care challenges. One area that did see agreement, though, was the recognition that far too many mothers in Texas get sick or die during pregnancy or within a year of a pregnancy ending. Unlike the decline of mortality rates internationally, U.S. maternal mortality rates have been increasing, and Texas’ maternal death rate infamously doubled between 2010 and 2012.1

Thankfully, the Legislature moved during special session to extend the state’s Maternal Mortality and Morbidity Task Force, which plays an important role in identifying and addressing the core issues contributing to maternal death and severe illness.

In its July 2016 report, the MMMTF found that black women are at the greatest risk of dying.2 Although only 11.4 percent of Texas births in 2011-2012 were attributed to black women, 28.8 percent of the deaths occurred among black mothers.

For all maternal deaths, the most common causes were cardiac events, drug overdose, and hypertensive disorders.

The number-one recommendation of the MMMTF was increasing access to health care for women during the year after delivery, along with improved continuity of care in the inter-conception period. These are efforts that family physicians can help with, both through our patient care and through our advocacy.

Clearly, primary and preventive care play critical roles in reducing maternal mortality. Primary care access means the possibility of detection and treatment of cardiac risk factors, substance abuse, depression, and hypertension, for example.

Unfortunately, many low-income and minority women are uninsured and do not have access to primary care. Medicaid covers many low-income pregnant women, but does not cover most low-income women who are not pregnant. Texas has the highest rate and the highest number of uninsured

women (and people) of any state; yet, our state has not taken advantage of the opportunity provided by the Affordable Care Act to expand Medicaid for many low-income adults.

Preventive care that includes contraception is a critical help as well. Access to contraception and other family planning services helps in at least two ways. First, contraceptive counseling and supplies prevent pregnancies that are not wanted or planned, thus reducing the physiological stress and other risks of a pregnancy on women not intending to become pregnant. Second, screenings provided in preventive care detect problems that need treatment, helping women prepare for a healthy pregnancy that is wanted and planned. In addition, planning pregnancy allows for healthy spacing between pregnancies, which means lower chances of preterm birth, low birthweight, and infant mortality. A healthy pregnancy begins well before a woman becomes pregnant.

Texas provides for two preventive health care programs that offer family planning and well-woman screenings for lowincome women. Healthy Texas Women features free contraceptive care; immunizations; and screenings for breast and cervical cancer, obesity, hypertension, diabetes, hypercholesterolemia, depression, exposure to abuse and/or violence, sexually transmitted infections, and substance abuse. Limited treatment for hypertension, diabetes, and high cholesterol is also covered. HTW covers women citizens who are 15-44 years old with incomes at or below 200 percent of the federal poverty level. Women who deliver a baby on Medicaid are automatically enrolled into HTW 61 days after delivery, which is when their Medicaid coverage ends. Family physicians can participate in this fee-for-service program in their practices if they are signed up as a Medicaid provider and certify that they do not perform abortions or affiliate with abortion providers.

Texas’ Family Planning Program serves Texas residents, both women and men, including undocumented people, up to age 64 with a similar package of preventive services, including diagnostic breast and cervical cancer services and limited prewww.tafp.org

17

The number-one recommendation of the Maternal Mortality and Morbidity Task Force was increasing access to health care for women during the year after delivery, along with improved continuity of care in the interconception period. These are efforts that family physicians can help with, both through our patient care and through our advocacy.

natal care. This program is based on a competitive grant and contract system. Family physicians can participate in this program if they are part of an organization (generally a safety-net clinic) that contracts with Texas Health and Human Services to provide these services. Undocumented women who deliver as part of the CHIP-Perinatal program can be referred to an FPP provider organization for contraception and follow-up after their two CHIP-P-covered post-partum visits.

Family physicians who provide maternity care can also ensure that their hospital participates in the Alliance for Innovation on Maternal Health Patient Safety Bundles to improve safety for pregnant and post-partum women.3 These Maternal Safety Bundles help ensure that the staff and systems are prepared to use best practices regarding common threats to maternal health and life.

Continuity of care is paramount for monitoring and treating women at risk for maternal mortality. Transitions into Medicaid for pregnant women and CHIP-P for women not eligible for Medicaid are often delayed and difficult. Late or no prenatal care, associated with many adverse outcomes, is far too common in Texas and is strongly associated with a pregnancy that is unplanned. In addition, transitions into HTW or FPP after a delivery are often delayed or completely lost. Too few women are made sufficiently aware of these services or perhaps they lack the support they need to access them. As a result, many new mothers fall out of care and miss out on health services at this potentially vulnerable stage of their lives. Better education of both women and providers is needed to bridge these gaps.

The Texas Women’s Healthcare Coalition is a coalition of 77 health care, faith, and community-based member organizations dedicated to improving the health and well-being of Texas women, babies, and families by ensuring access to preventive health care — including contraception — for all Texas women. During the legislative interim, we encourage the Legislature to study how women can be better connected to family planning services postpartum. We are working with providers of all types to improve they system, reduce unplanned pregnancy, and decrease maternal mortality.

Family physicians play a critical role in this work. The TWHC is grateful for the active support and engagement of the Texas Academy of Family Physicians, an indispensable member of the TWHC Steering Committee.

1. MacDorman MF, et al. Recent Increases in the U.S. Maternal Mortality Rate. Disentangling Trends from Measurement Issues. Obstet Gynecol 2016; 128:1-10.

2. Joint Biennial Report. Maternal Mortality and Morbidity Task Force and Department of State Health Services. Department of State Health Services, July 2016.

For more information, or to find local HTW, FPP, and other women’s health care providers, please visit healthytexaswomen.org and whfpt.org. For information about TWHC, visit TexasWHC.org.

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TEXAS FAMILY PHYSICIAN [No. 3] 4] 2017

3. Alliance for Innovation on Maternal Health Patient Safety Bundles. Accessible at http://safehealthcareforeverywoman.org/patient-safety-bundles/.

Janet Realini, MD, MPH, is a family physician in San Antonio, Texas. She is the founder and associate vice president of Healthy Futures of Texas.

“It’s a wonderful thing to practice family medicine in the state of Texas, to have the opportunity to get to know our patients and their families and to take care of them. As members of the Texas Academy of Family Physicians, we don’t just care for our patients in the exam room. We take care of them at the State Capitol, too.

“I’m a monthly donor for the TAFP Political Action Committee because if we want policies that are good for our patients and our practices, we have to elect politicians who understand our issues. Support TAFPPAC and make your voice heard.”

Justin Bartos, MD 2016 TAFPPAC Award recipient

www.TAFPPAC.org

PHYSICIAN BURNOUT is no joke. With prior authorizations and utilization review, quality measurements, and the usual hamster wheel of fee-forservice care, it seems like you spend less of your day with patients each year. And when you get home? Oh yeah, it’s time to finish up those charts.

Three words: electronic health records.

Enough said.

Add in MACRA, MIPS, QPP, APMs, QRURs and the rest of the alphabet soup from CMS, and it’s no wonder you want to go AWOL. According to a Medscape physician lifestyle survey from 2015,

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TEXAS FAMILY PHYSICIAN [No. 4] 2017

up to 53 percent of physicians suffer from occupational burnout, which they define as exhaustion, detachment or cynicism, and a low sense of achievement.

We hear you. And we know treating the symptoms of physician burnout won’t cure the real problems that plague the American health care system and lead to distress and frustration among doctors. But while we work to solve those problems, it’s important that you pay attention to your own wellbeing and that of your colleagues.

AAFP recently launched a set of initiatives and tools to help stave off occupational burnout and help you stay mindful of your well-being. It’s called Physician Health First. You can check out the collection of videos, articles, and resources at aafp.org/ membership/benefits/physician-healthfirst.html. In this edition of Texas Family

Physician, we’d like to introduce you to Physician Health First with a set of articles from AAFP. So sit back, relax, and read for a minute.

And don’t forget to breathe. :)

www.tafp.org

21

PHYSICIAN HEALTH FIRST

AAFP initiative offers new resources for physician well-being

By Sheri Porter

amily physicians attending the opening ceremony of the AAFP’s 2017 Family Medicine Experience in San Antonio on Sept. 14 were privy to the launch of a dynamic new Academy initiative that shines a spotlight on physician well-being.

Clif Knight, MD, AAFP’s senior vice president for education, introduced his colleagues to a new program developed just for family physicians dubbed Physician Health First. The initiative is built around a web portal that is now open for business and waiting for physicians to explore.

Knight told the crowd that improving family physicians’ wellbeing is one of the Academy’s strategic goals and a priority of the AAFP Board of Directors — in part because research shows that family physician burnout is at an all-time high.

In fact, two-thirds of family physicians report at least one element of burnout, said Knight, and family medicine is among the top five medical specialties reporting burnout.

“Recently we surveyed you, our members, to determine your professional satisfaction and sense of physician well-being,” Knight said.

“We heard you say, ‘Stop trying to fix me. I’m not the problem. Fix the system, and I’ll be fine.’”

Knight asked for a show of hands from the physicians in the audience to indicate if they had ever experienced any sort of extreme stress or burnout. Hands shot up across the vast expanse of the ballroom.

“Now, keep those hands up if you are still experiencing a sense of significant stress or burnout right now,” Knight said.

Very few hands went down.

“I don’t think this demonstration surprises anyone,” Knight said.

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TEXAS FAMILY PHYSICIAN [No. 4] 2017

With the help of graphics on video screens, he walked physicians through what he called the “framework” of five levels of the family physician ecosystem that can affect the risk of physician burnout.

First on the list was the U.S. health care system and its labyrinth of burdensome regulations. Next up, the term “organization” — a place where “professional satisfaction is influenced by those making decisions where you work,” Knight said.

Next on the list, a physician’s practice environment and practice team, followed by the individual — because all physicians have personal wellness habits and resiliency skills that allow them to bounce back after stress.

And finally — but certainly of equal importance — came the impact of the physician culture, “the workaholic habits that we were trained and conditioned to value above our own well-being.”

It’s not sustainable, Knight said.

“The stigma of stress and burnout as a sign of individual weakness brings a sense of guilt and shame when we don’t feel like we are strong enough doctors.”

Knight ran through various scenarios: a typical busy day at the practice that leads to three hours of administrative work after closing, days on end juggling varied responsibilities as a residency program director, or many hours spent every day overseeing a vast collection of people and problems as the chief medical officer for a large hospital system. All of these situations carry the risk of physician burnout, Knight said.

“How do I know this? Because over my 25-plus years in family medicine, I’ve served in each of these roles. I’ve witnessed burnout firsthand, and I’ve learned that it affects everyone differently,” Knight said.

Knight said he’s spent some time over the past couple of years asking physicians what is causing their burnout, and the answer he heard most often was the broken promise of electronic health records. Other stressors include regulatory burdens, workload, the push to see a higher volume of patients and medical school debt.

The Physician Health First web portal was designed specifically to “inspire, energize and motivate” family physicians to evaluate their well-being and then give them tools they need to assess and address their risk of burnout, Knight said.

He described the portal -- strongly supported by the AAFP Foundation — as a “one-stop shop” on physician well-being that is home to a plethora of resources. One of these is free member access to the Maslach Burnout Inventory to get physicians started on their well-being journey.

“I realize that it may feel selfish. It may not feel right to put your own health and well-being before that of your patients,” Knight said.

“But family doctors, hear me when I say you are indispensable.

And to be strong family physicians and to serve your patients best, you must put your well-being first. I promise your patients, your practice, your families will thank you for it.”

Knight urged family physicians to use their time at FMX to take their well-being to the next level.

“Get ready to engage and recharge your energy with one another — a community of strong family physicians who believe in the power of our specialty,” he said. “We are the solution to the broken health care system.”

Knight emphasized physician well-being activities taking place at FMX and invited all family physicians to attend a new AAFP event, the Family Physician Health and Well-being Conference, scheduled for April 18-21, 2018, in Naples, Florida.

Source: AAFP News, Sept. 15, 2017. © American Academy of Family Physicians.

“I realize that it may feel selfish. It may not feel right to put your own health and well-being before that of your patients. But family doctors, hear me when I say you are indispensable. And to be strong family physicians and to serve your patients best, you must put your well-being first. I promise your patients, your practice, your families will thank you for it.”

Clif Knight, MD AAFP senior vice president for education

Fresh Perspectives New Docs in Practice

I bounced back from burnout by setting boundaries, priorities

By Kimberly Becher, MD near the end of 2016, I reached a point in medicine where I never wanted to be. Less than three years out of residency, I realized I was burnt out.

It was at that point that someone asked me whether I would still choose medicine as a career if I had it all to do over again, and I said no.

I hated hearing that answer as a medical student and resident, but not because I was afraid for my own future. I honestly thought physicians who regretted their career decisions were failing themselves because they weren’t trying to change the things that made them miserable. So when I reached that point myself, it forced me to begin some serious introspection.

The first thing I did when the realization hit me was stop taking medical students because my focus was not on teaching. I knew I needed to make serious changes in my life and my practice, and that process could make family medicine in general seem like a less desirable career choice if it were a student’s only exposure to our specialty.

Things are getting better now, and I have a student scheduled for September. So how did I get back on track?

I knew part of my problem was depression. I wasn’t taking time for myself, and I hadn’t taken a true vacation that didn’t involve checking my electronic health records daily in more than two years.

I wasn’t exercising because I felt I didn’t have time because of the number of notes and tasks I had looming over me every evening. My house was a disaster. I wasn’t cooking or eating as healthily as I used to. I spent little time with my family. The only thing I continued to do well was care for my patients.

The first step I had to take was the hardest. I had to start saying no. No to new patients, no to being double-booked, no to addressing four patients who happen to be in the same room when only one of them is on my schedule. No to taking care of employees off the schedule. I had to create a daily routine that not only kept my head above water but also gave me time to catch my breath.

Fortunately, I had a couple of conferences in the spring that forced me out of the office and gave me time to analyze my workflow more clearly. I also did some critical thinking about my own weaknesses.

I dug through old leadership books because I knew that to really change things in my office, I had to have an engaged workforce. Any physicians who think they can run an office effectively without [cont. on 24]

www.tafp.org

23

AAFP offers free physician well-being CME videos

By Chris Crawford

After finishing Greenawald’s session, participants should be able to: • identify key characteristics of the practice environment that influence satisfaction, • describe their present practice culture and apply a framework to envision the ideal practice culture, and • develop a plan to help lead their practices to a higher level of enjoyment in providing care.

AAFP recently added three free CME videos to the Physician Health First portal that launched Sept. 14 at the Academy’s 2017 Family Medicine Experience.

The portal was created as part of a focus on physician well-being ­­— one of the Academy’s strategic goals — in light of research that showed physician burnout is at an all-time high.

Originally recorded live at FMX, the CME sessions are Jay Winner, MD’s presentation on Becoming a More Relaxed, Healthy Physician, Mark Greenawald, MD’s presentation on Creating a Thriving Practice Culture and Vu Kiet Tran, MD, MBA’s presentation on Leadership Skills for Non-leaders.

Each of these self-study, on-demand sessions is free to AAFP members and worth up to 1.25 CME credits.

CME session objectives, commitment to change Each CME session offers specific learning objectives for family physicians who participate.

Those who complete Winner’s session should be able to: • use simple mindfulness skills to reduce stress, increase satisfaction and improve connection with patients; • use reframing to reduce frustration and increase empathy with even the most difficult patients; and • apply techniques to deal effectively with difficult emotions and regain a healthy perspective.

Finally, after completing Tran’s session, participants should be able to: • identify key skills of everyday leadership for the non-leader clinician, • describe how these characteristics can improve patient care, and • describe benefits to the practice and organization.

Wes James, MEd, CME learning strategist for AAFP, told AAFP News that more than 26 percent of members who claimed CME credits from FMX participated in at least one of the three sessions that were offered as part of the physician well-being track.

About 36 percent of learners who attended the well-being sessions at FMX said they planned to implement something they learned in their practice, James said. For comparison, about 24 percent of all learners at FMX planned to implement something they picked up at the conference.

Family physicians who attended the Becoming a More Relaxed, Healthy Physician session left comments about their commitment to change after completing the course, including being more mindful through patient interactions, using relaxation techniques such as deep breathing and taking moments to meditate.

Members who completed the Creating a Thriving Practice Culture session said they would focus on having fun with staff and acknowledging their good work, and would consider holding more team huddles.

Those who attended the Leadership Skills for Non-leaders session said when they got back to their offices, they would focus on being more self-aware, being a role model for staff, and empowering their colleagues.

Source: AAFP News, Nov. 10, 2017. © American Academy of Family Physicians.

[cont. from 23]

building staff morale and a solid approach to patient-centered care are fooling themselves. Who hasn’t heard the saying “You are only as good as your staff?”

After a few months of changes in the office, I started to see the light, literally, because I wasn’t working until after dark anymore. My patient navigator was accessible because I freed her up from some front-office duty so fewer things fell through the cracks (or accumulated on my mental to-do list for later that night). My schedule still was full every day, but I wasn’t double- and triple-booked.

I found that I could handle a completely full schedule just fine.

Overbooking had been the Achilles heel in my day. If I let myself get an hour behind, I lost all discipline with notes, orders and referrals, pushing it all until after the last patient had left the office.

I had been miserable because I didn’t have time to exercise, spend time with my family or go on vacation, but could I make needed changes in my life and give up some of the obsessing about my EHR task list? I had to start with small changes or I felt my work-related anxiety would sabotage me.

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I was invited to speak at the National Rural Health Association meeting in early May in San Diego, so while I was there, I got up and exercised every morning before logging into my computer. I already knew that exercise was the most effective antidepressant for me, but I hadn’t realized until that week how much more efficient I was when I exercised every day. And as embarrassing as it is to admit, I went to a yoga class for the first time in at least a decade. (Teaching yoga was one of the interests that motivated me to be a doctor in the first place.)

I came home with much clearer goals. I was going to incorporate exercise into my day at any cost: hungry family waiting at home, phone calls unanswered, changing my work schedule if necessary. And so far, I’ve met that goal. I have a schedule change in the works that will enable me to exercise in the morning, which will mean I work through lunch with no break, but it will also allow me to take my son to school.

Then came the daunting challenge of vacation. I knew I needed a break, one where I would have no phone or internet because if I had online access, I would still work. [cont. on 26]

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[cont. from 24]

Your health before

all else.

INT RO DUCI NG

AAFP Physician Health First is the first-ever comprehensive initiative devoted to improving the well-being and professional satisfaction of family physicians, and reversing the trend toward physician burnout.

Discover a wealth of well-being at aafp.org/mywellbeing.

Supported in part by a grant from the American Academy of Family Physicians Foundation.

Six months later, I have lost 10 pounds, and I am in better shape than I’ve been since I started medical school. I’ve left my office every day for five consecutive weeks with all notes and tasks completed.

I’ve gone on at least a biking or hiking day trip with my family every weekend since the end of the school year.

I hate asking people to cover for me. It isn’t a trust or medical decision-making issue. I feel guilty for putting so much work on someone else. But I went to Costa Rica and didn’t take a computer or buy an international data plan for my phone. What I found reassuring was that when I told my high-risk patients that I would be inaccessible for a week, they encouraged me to do it more often!

We have all had patients make snide comments about us being out of the office on occasion, and I have felt as though I failed them when they needed me. But patients have to be realistic — and so do we. Physicians are humans, too, and we also experience things like flat tires or illness.

Six months later, I have lost 10 pounds, and I am in better shape than I’ve been since I started medical school. I’ve left my office every day for five consecutive weeks with all notes and tasks completed.

I’ve gone on at least a biking or hiking day trip with my family every weekend since the end of the school year.

I am seeing more patients per hour now than I was six months ago, but they are scheduled more appropriately. Every appointment time is filled during the course of the day rather than, for example, being overbooked multiple times in a three-hour period. I’m sure some patients can tell a difference. I do find myself a couple of times per week telling patients that we just have to stop for the day and that we need to see each other more often instead of for so long at once. If family members start asking me questions about themselves during someone else’s appointment, I sign them in to be seen so I get credit for my time and they understand that to get medical care, you really do need an appointment. I tell staff point-blank when they ask me medical questions about themselves that they need to get on my schedule.

It was a long, hard road, but I eventually realized that my sanity is more important than being nice. And sometimes it is just about letting go of things (my house is still a disaster) and remembering who we were when we started our journey into medicine.

Kimberly Becher, MD, practices at a rural federally qualified health center in Clay County, West Virginia.

Source: AAFP Fresh Perspectives, July 24, 2017. © American Academy of Family Physicians.

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TEXAS FAMILY PHYSICIAN [No. 4] 2017

No-see, no-handle needle No reconstitution required No need to dial a dose 1,2

TrulicityÂŽ (dulaglutide) is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease.

Select Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure.

It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.

Preparation2 •

Check the pen to be sure it is not expired, damaged, cloudy, discolored, or has particles in it

•

Choose an area for injection (abdomen or thigh), being sure to choose a different site (even within area) each week

The key administration steps

Disposal2

2

•

1

2

3

Uncap the pen

Place and unlock

Press and hold

Disposal2

• pen Dispose of the Dispose in of the pen in a closable puncturea closable punctureresistant container resistant and container and not in household not trash in household trash

Please review Please thereview full Instructions the full Instructions for Use with for your Use with patients yourtopatients ensure they to ensure they understand understand how to properly how toadminister properly administer Trulicity. Trulicity.

Select Important Safety Information • Trulicity is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia

syndrome type 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components.

• Cases of medullary thyroid carcinoma (MTC) in patients treated with liraglutide, another GLP-1 RA, have been reported in the postmarketing period; the data

in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

Yes, I think I can do this

*

In a study, 99% of patients reported that overall, the Trulicity Pen was easy or very easy to use3

•

Patients with type 2 diabetes who were naïve to self-injection and injecting others (n=214) participated in a phase 3b, multicenter, open-label, single-arm, outpatient study on the safe and effective use of the Trulicity single-dose pen

•

The primary objective was to achieve a final injection success rate (proportion of patients who successfully complete injection) significantly greater than 80%

•

Patients were trained at baseline on proper self-injection technique with the pen

•

Final injection (4th weekly injection) success was observed in 99.1% [95% CI: 96.6% to 99.7%] (n=209) of patients (primary objective met). Success determined by evaluation of patients’ ability to accurately complete each step in the sequence of drug administration

•

After the final self-injection, patients completed a 12-item ease of use module (secondary endpoint). 209 (99%) out of 210 patients reported that overall, the single dose pen was “easy” or “very easy” to use

To see how Trulicity can help your patients start injectable therapy, visit Trulicity.com/yesican

*Patient will need additional assistance from their healthcare professional as well as to review the full Instructions for Use included with the Trulicity Pen. Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages and accompanying Brief Summary of Prescribing Information.

Please see Instructions for Use included with the pen.

Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatmentduration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutideinduced rodent thyroid C-cell tumors has not been determined.

Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.

Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.

Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions and angioedema) in patients treated with Trulicity. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist as it is unknown whether they will be predisposed to anaphylaxis with Trulicity.

Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.

In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions.

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Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity.

The most common adverse reactions (excluding hypoglycemia) reported in ≥5% of Trulicity-treated patients in placebo-controlled trials (placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%,12.4%, 21.1%), diarrhea (6.7%, 8.9%,12.6%), vomiting (2.3%, 6.0%,12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%).

Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.

Pregnancy: Limited data with Trulicity in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide. Use only if potential benefit justifies the potential risk to the fetus.

Lactation: There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age.

Please see Brief Summary of Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages.

Please see Instructions for Use included with the pen.

DG HCP ISI 06FEB2017 Trulicity® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Trulicity is available by prescription only.

Other product/company names mentioned herein are the trademarks of their respective owners.

References 1. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC. 2. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 3. Matfin G, Van Brunt K, Zimmermann AG, et al. Safe and effective use of the once weekly dulaglutide single-dose pen in injection-naïve patients with type 2 diabetes. J Diabetes Sci Technol.

2015;9(5):1071-1079.

©Lilly USA, LLC 2017. All rights reserved.

Trulicity® (dulaglutide) Brief Summary: Consult the package insert for complete prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS • In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

• Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.

Trulicity and other suspected medications and promptly seek medical advice. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with Trulicity. Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal failure, use caution when initiating or escalating doses of Trulicity in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity.

ADVERSE REACTIONS

Risk of Thyroid C-cell Tumors: In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether Trulicity will cause thyroid C-cell tumors, including MTC, in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. One case of MTC was reported in a patient treated with Trulicity. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of Trulicity and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. Pancreatitis: In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis-related adverse reactions were reported in patients exposed to Trulicity versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analysis of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to Trulicity (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years). After initiation of Trulicity, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue Trulicity. If pancreatitis is confirmed, Trulicity should not be restarted. Trulicity has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Trulicity. If a hypersensitivity reaction occurs, the patient should discontinue

Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Pool of Placebo-controlled Trials: These data reflect exposure of 1670 patients to Trulicity and a mean duration of exposure to Trulicity of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations.

Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Trulicity-Treated Patients: Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5 mg (N=834) (listed as placebo, 0.75 mg, 1.5 mg): nausea (5.3%, 12.4%, 21.1%), diarrheaa (6.7%, 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%, 4.2%, 5.6%). (a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.) Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.75 mg and 1.5 mg of Trulicity as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively. In addition to the adverse reactions ≥5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%; 3.9%; 3.7%), flatulence (1.4%; 1.4%; 3.4%), abdominal distension (0.7%; 2.9%; 2.3%), gastroesophageal reflux disease (0.5%; 1.7%; 2.0%), and eructation (0.2%; 0.6%; 1.6%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of Trulicity as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3342 patients with type 2 diabetes were treated with Trulicity for a mean duration 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as ≥5% above. Other Adverse Reactions: Hypoglycemia: Incidence (%) of Documented Symptomatic (≤70 mg/dL Glucose Threshold) and Severe Hypoglycemia in Placebo-Controlled Trials: Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), Trulicity 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5 mg: 5.0%; Severe: all 0. Add-on to Glimepiride at 24 weeks, Placebo (N=60), Trulicity 1.5 mg (N=239), Documented symptomatic: Placebo: 1.7%, 1.5 mg: 11.3%; Severe: all 0. Add-on to Insulin Glargine with or without Metformin at 28 weeks, Placebo (N=150), Trulicity 1.5 mg (N=150), Documented symptomatic: Placebo: 30.0% 1.5 mg: 35.3%; Severe: Placebo: 0% 1.5 mg: 0.7%. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. In a 78-week clinical trial documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented

Trulicity® (dulaglutide)

Trulicity® (dulaglutide)

INDICATIONS AND USAGE Trulicity® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease.

CONTRAINDICATIONS Do not use in patients with a personal or family history of MTC or in patients with MEN 2.

Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components.

WARNINGS AND PRECAUTIONS

DG HCP BS 10FEB2017 7 x 9.5

DG HCP BS 10FEB2017 7 x 9.5

symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with prandial insulin. Severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg, and 1.5 mg, respectively, was co-administered with prandial insulin. Heart Rate Increase and Tachycardia Related Adverse Reactions: Trulicity 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm). The long-term clinical effects of the increase in HR have not been established. Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to Trulicity. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively.

Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4%, and 1.6% of patients treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3%, and 2.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively.

Immunogenicity: Across four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) Trulicitytreated patients developed anti-drug antibodies (ADAs) to the active ingredient in Trulicity (ie, dulaglutide). Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies against native GLP-1.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products. Hypersensitivity: Systemic hypersensitivity adverse reactions sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and Phase 3 studies. Injection-site Reactions: In the placebo-controlled studies, injection-site reactions (eg, injection-site rash, erythema) were reported in 0.5% of Trulicity-treated patients and in 0.0% of placebo-treated patients. PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) Block: A mean increase from baseline in PR interval of 2-3 milliseconds was observed in Trulicity-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with Trulicity than placebo (0.9%, 1.7%, and 2.3% for placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5%, and 3.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Amylase and Lipase Increase: Patients exposed to Trulicity had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebotreated patients had mean increases of up to 3%. Postmarketing Experience: Anaphylactic reactions have been reported during post-approval use of Trulicity. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

DRUG INTERACTIONS Trulicity slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to any clinically relevant degree.

USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary Limited data with Trulicity in pregnant women are not sufficient to determine a drug associated risk for major birth defects and miscarriage. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 14-times human exposure at the maximum recommended human dose (MRHD) of 1.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 13-times human exposure at the MRHD. Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide.

Lactation: Risk Summary There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trulicity and any potential adverse effects on the breastfed infant from Trulicity or from the underlying maternal condition. Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years. Geriatric Use: In the pool of placebo- and active-controlled trials, 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations. In a clinical pharmacology study in subjects with Trulicity® (dulaglutide)

DG HCP BS 10FEB2017 7 x 9.5

varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. Renal Impairment: In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicity-treated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2).

No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed. There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored. Gastroparesis: Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with pre-existing gastroparesis.

OVERDOSAGE Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (eg, nausea, vomiting) and non-severe hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms.

PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide • Inform patients that Trulicity causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician. • Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Trulicity promptly, and to contact their physician, if persistent severe abdominal pain occurs.

• The risk of hypoglycemia may be increased when Trulicity is used in combination with a medicine that can cause hypoglycemia, such as a sulfonylurea or insulin. Review and reinforce instructions for hypoglycemia management when initiating Trulicity therapy, particularly when concomitantly administered with a sulfonylurea or insulin. • Patients treated with Trulicity should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with Trulicity of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs. • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of Trulicity and other GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, patients must stop taking Trulicity and seek medical advice promptly. • Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant. • Prior to initiation of Trulicity, train patients on proper injection technique to ensure a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inform patients of the potential risks and benefits of Trulicity and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and advise patients to seek medical advice promptly. • Each weekly dose of Trulicity can be administered at any time of day, with or without food. The day of once-weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before. If a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, it should be administered as soon as possible. Thereafter, patients can resume their usual once-weekly dosing schedule. If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, the patient should not administer the missed dose and instead resume Trulicity with the next regularly scheduled dose. • Advise patients treated with Trulicity of the potential risk of gastrointestinal side effects. • Instruct patients to read the Medication Guide and the Instructions for Use before starting Trulicity therapy and review them each time the prescription is refilled. • Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. • Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range.

HbA1c is especially useful for evaluating long-term glycemic control.

Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2014, 2015, Eli Lilly and Company. All rights reserved.

Additional information can be found at www.trulicity.com DG HCP BS 10FEB2017 Trulicity® (dulaglutide)

DG HCP BS 10FEB2017 7 x 9.5

MEDICAL EDUCATION

THE PACE OF AMERICAN MEDICAL TRAINING

By Travis Bias, DO, MPH, DTM&H in his commencement address at Kenyon College in 2005, the late author David Foster Wallace told the story of two young fish swimming along. They pass an older fish swimming the other way who greets them: “Morning boys. How’s the water?” As they swim on, one of the younger fish responds to the other: “What the hell is water?”

Feeling and appreciating your body of water takes experience, maturity, and occasionally someone else making you aware of your daily surroundings. It was not until a few years into my career as a family medicine physician that I realized the furious pace at which American physicians learn to swim, insulated in a system that operates in stark contrast to that of other countries around the world.

What kind of young physicians is our system creating?

Six months into my first year of residency, I was on a rotation with an energetic orthopedic surgeon. Our residents looked forward to our time with him. Residency training is a time for young physicians to drink from a fire hose of information during long work hours, learning not just clinical medicine but also the business of health care. As we stood outside the exam room preparing to see the next patient, the topic of medical malpractice came up.

“Every time I walk into a patient room, I see the patient in front of me, the insurance representative on the right, and the malpractice lawyer to the left,” he said.

At our morning report following nights on call in the hospital, we would present each admitted patient to our attending physician who taught us clinical pearls and also regaled us with stories regarding malpractice cases that had arisen from similar situations. He helped us refine our documentation and ensure our trail of charting and medical care would back us up in the event of a lawsuit.

Several times faculty physicians reinforced my plan to order studies to ensure a life-threatening condition was ruled-out. Many could have been reliably excluded with physical exam signs or patient risk factors, but I had been trained to rely on technology to definitively prove my clinical hunch. I have never been the subject of a medical malpractice lawsuit, but I practice as if I have.

So each month, I gathered nuggets of information from my professors regarding medical business practice, detailed documentation, and using technology to prove diagnoses. These lessons all slowly seeped deep into my practice habits. And, much like an older brother repeating a parents’ teachings to a younger impressionable sibling, I taught these to junior residents and medical students.

Then came several stints in a rural health center in Kenya and a three-month course in tropical medicine put on by the London School of Hygiene and Tropical Medicine in Tanzania and Uganda.

My classmates were from the United Kingdom, Australia, Germany, Tanzania, Uganda, and even Botswana, among other countries. Out www.tafp.org

33

I finished training as quickly as possible at the age of 29 with just over $200,000 in debt and no savings, and then entered practice in the fee-for-service system. And the path of least resistance was to follow the volumebased carrots laid out by my predecessors.

of the 57 young physician students from around the world, I was the only American. Through work in the resource-limited health center in Kenya and a subsequent year of teaching medicine in East Africa, and discussions with my tropical medicine classmates, I started to see my water more clearly.

Fear of medical malpractice lawsuits and defensive medicine are unique American system attributes. The private fee-for-service system without a firm foundation of public care is an American trait. Patient cost sharing having no basis on the actual cost of care makes the US health sector unlike any other. Mountains of educational debt following medical school are only found in the American system. The large pay increase in that first year as an independently practicing physician after postgraduate training is a massive incentive only present stateside.

How do these elements affect health care delivery in one of the strongest economies on the planet?

In the documentary film “Escape Fire,” former Centers for Medicare and Medicaid Services Administrator Donald Berwick says he does not blame anyone in the American system for doing what they are doing. Hospitals fill hospital beds because they are incentivized to do so. Physicians enter lucrative sub-specialties at times partially motivated by the need to pay off educational debt, and many go straight through medical school and residency eager to absolve that debt. Seventy-six percent of American physicians graduate medical school with an average of almost $190,000 of educational debt. Can we blame them for sometimes seeking more profitable specialties and blazing straight through training? I finished training as quickly

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as possible at the age of 29 with just over $200,000 in debt and no savings, and then entered practice in the fee-for-service system. And the path of least resistance was to follow the volume-based carrots laid out by my predecessors.

The lessons of older physicians are percolating down to breed younger physicians with similar attitudes. And that should be concerning. What were once young idealistic physicians, are now caregivers entering a post-Affordable Care Act system with the same views as a physician who was raised in the fee-for-service scheme.

How do we incentivize young physicians to enter the right mix of specialties and shape them to serve an aging population in a changing system?

We must start by addressing the cost of medical education. Without the heavy debt burden, financial incentives lose their power. Next, improve the pay during postgraduate training, while encouraging extended breaks in training, if the physician so chooses, through funding or built-in time away from the home institution. This time away could be used for international rotations, administrative or policy placements, or exploring research opportunities that interest them.

For example, young British physicians take months, sometimes years, away from their postgraduate medical education to work with non-governmental organizations or in academic settings in low-income countries. During this time out of their comfort zone, physicians have more time for self-reflection while pursuing personal interests. This may very well extend the length of training, but without debt creating the race to finish, this would be less bothersome to young physicians. In fact, many young physicians start out craving these seemingly extracurricular

experiences, but there is currently little time or support for what would be key to a physiciansâ&#x20AC;&#x2122; personal and professional growth.

When the system of education changes to encourage outside perspective-gathering experiences, our system may well end up with physicians whose incentives better align with the most important health care player of all: the patient. That physician will be more confident in her physical exam skills rather than relying on technology, which will in turn lower costs in the most expensive health care system in the world. That physician will be more in tune with herself and the need to care for herself before caring for others, thus lowering chances for burnout and improving longevity. That physician will be more empathetic to patient needs, leading to higher quality care.

One must smell poverty to recognize the stench of inequality. You have to be confronted with true hopelessness to detect suffering. You must feel, at some point, uncomfortable to identify vulnerability.

Learning medicine takes years of study, sacrifice, and repetitive pattern recognition. Caring for another human takes a self-awareness that requires an intimate full-sensory appreciation of your surroundings. And only with these skills sharpened can the leaders of our health system take that vital swim alongside their patient.

Travis Bias, DO, MPH, DTM&H, is a family medicine physician, a former professorial lecturer at the Milken Institute School of Public Health at the George Washington University, and a former visiting lecturer in Kenya and Uganda. He used to live in Texas, but alas, he moved to California.

Tweet him @Gaujot and read his posts at https://globaltablechat.com/.

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PERSPECTIVE

How the CCO model would address our nation’s health care crisis

By Jim Rickards, MD, MBA back in 2011, the state of oregon was facing a massive budget deficit, primarily driven by rising Medicaid costs. Medicaid is government-supported health insurance for economically disadvantaged individuals earning up to 138 percent of the federal poverty level.

About 25 percent of Oregon’s population, nearly 1 million individuals, are currently enrolled in Medicaid. This is a similar percentage to what is seen nationally. Not only did the deficit substantially impact the state’s overall budget for health care funding, but the potential impact on the lives of many Oregonians also weighed heavy on the medical community.

Typically, when states try to manage deficits related to Medicaid, they employ a combination of three strategies.

For one, they will decrease reimbursement rates to hospitals and providers. This does not work very well because, ultimately, clinics will need to limit the number of Medicaid members they see since they are not financially viable, in turn creating access issues for patients. Second, the number and types of covered services can be restricted by the state. In Oregon, we had already employed the Prioritized List of Health Services for more than 20 years, which served as an evidence-based approach to prioritizing and limiting the availability of health care services. Limiting what was already on the list would not have been possible without denying many essential services. Finally, a state can decrease the number of individuals enrolled in Medicaid. This was not an option either, as Oregon was going to be an expansion state under the Affordable Care Act and would see its Medicaid population grow from 600,000 to a little over 1 million members within just a short time.

Oregon’s approach was to take the fourth path and develop a new model to deliver Medicaid benefits, the Coordinated Care Model.

Under this model, the state would pass legislation and receive an 1115 waiver from the federal government, which allowed it to create new community-governed health insurance plans for the Medicaid population called Coordinated Care Organizations or CCOs. Medicaid members enrolled in CCOs reside within a defined geographic region and receive funding for their medical, behavioral health, and dental care benefits by a single global budget the state defined.

A significant component of the CCOs was the focus on community governance. The board of the CCO needed to have a local primary care physician still in practice, a behavioral health provider, a representative from local public health departments, as well as several local elected officials. Additionally, each CCO could have a clinical advisory panel made up of various actively practicing health care providers including physicians, social workers, and dentists, among others. As a physician, I saw the CCO framework as a formal way for me to work with others in my community on addressing population health and the various determinants of health. As a result, I helped

my community apply for and become recognized as one of 16 CCOs in the state of Oregon.

The CCO then provided me with a number of opportunities and a community-wide platform to improve the community’s health. One example of this was the development of a community paramedicine program. As a result of conversations in the CCO, we realized as a community that one of our local fire departments had extra capacity with its paramedics and ambulances. They were looking for work and additional revenue. Thus, we proposed incorporating them both into a transition-of-care strategy for Medicaid members discharged from the hospital. When transitioning back home, the last thing I wanted was to see those patients be re-admitted, especially when it could have been prevented.

The idea was to create a so-called paramedicine program, whereby paramedics could perform nonemergency visits to Medicaid members’ homes after they were discharged from the hospital.

Paramedics could help with a variety of issues such as medication reconciliation, laboratory specimen collection and safety checks. The CCO was able to fund this initiative after input and approval from the governing board and clinical advisory panel.

Not only were the lives of patients improved, but the local economy was stimulated at the same time.

From a physician standpoint, the CCO model has been successful in providing a platform to address the population health needs as well as the so-called determinants of health. These include all the aspects of life such as our behaviors, socioeconomic status, and level of education that determine our health in addition to the medical care we receive.

Financially the model has been successful by helping to keep annual Medicaid cost increases under 3.4 percent per year for the last five years. Alongside cost savings, even quality metrics have seen improvement. Currently, more than 90 percent of Oregon Medicaid members are enrolled with a state-recognized medical home, which provides recognized organized systems of care. Hospital readmission rates for preventable conditions have decreased by 30 percent since 2011. And finally, avoidable admissions for chronic diseases such as diabetes have dropped by up to 20 percent under the model.

The CCO model has worked for Oregon Medicaid from a financial, clinical, and quality perspective. Additionally, it is a model which is attractive to either side of the political aisle given its focus on fiscal stewardship and access to care. Examining its success and advantages could prove quite valuable in determining the next step in overhauling our nation’s health care system.

As a physician, I saw the CCO framework as a formal way to work with others in my community on addressing population health and the various determinants of health.

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TEXAS FAMILY PHYSICIAN [No. 4] 2017

Jim Rickards, MD, MBA, is the Senior Medical Director for Population Health and Delivery System Collaboration at Moda Health in Oregon.

He is the author of “Our Health Plan: Community Governed Healthcare That Works.”

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TEXAS FAMILY PHYSICIAN [No. 4] 2017