THE ROLE OF THE
SPECIALTY PHARMACY THE IMPORTANCE OF OUR
MICROBIOME NONALCOHOLIC
FATTY LIVER DISEASE
Naomi Judd
BLOATING & SUCROSE INTOLERANCE: THE MISSING LINK
SUMMER 2016
guttelling you?
gut
What’s your
nausea, vomiting
GI bleeding, diarrhea
abdominal pain, constipation, gas
When it goes beyond “was it something I ate” to “OMG, this is unbearable,” it’s time to visit the ER.
Cramps, bloating, vomiting, diarrhea, nausea and sharp abdominal pain can have other serious reasons lurking behind them. When home remedies and over-the-counter laxatives, pain relievers and antacids don’t seem to work, listen to your gut—visit our ER immediately. For answers to your health questions or a FREE physician referral, call 305-480-6666 or visit MiamiDadeHospitals.com. Text ER to 32222* to see average wait times. Message & Data Rates May Apply. Terms & Conditions http://www.texterhelp.com/. Privacy Policy http://www.HCAEastFlorida.com/.
Caring for you and those you love.
MISSION
To provide outstanding medical care and an exceptional healthcare experience.
GUIDING PRINCIPLE
We will treat each patient as a valued member of our immediate family.
CORE VALUES Care and Compassion Provide competent, individualized care in a professional, respectful and caring way. Teamwork Recognize each other as valuable members of our healthcare team by treating one another with loyalty, respect and dignity. Responsibility Provide excellent and efficient administrative, accounting, personnel and business management services. Value and Excellence Develop valuable ancillary services that improve our patients’ quality of care and customer experience.
Honesty and Integrity Communicate openly and honestly, build trust and conduct ourselves according to the highest ethical standards. Stewardship Attract and retain great talent and the finest gastroenterologists by actively promoting a professionally satisfying work environment. Accountability Maintain mutually beneficial relationships with top referring physicians, payers, employers and health systems using performance, outcome, as well as satisfaction measurements to demonstrate accountability and improvement in our care delivery.
Gastro Health Welcomes You Index
NAOMI JUDD: SINGER, SONGWRITER AND SURVIVOR by Michelle Menendez This issue of the Gastro Health Magazine features Naomi Judd, a well-known country singer, baby boomer and Hepatitis C survivor. Before rising to fame Naomi was an intensive care nurse in Nashville, TN who unknowingly contracted Hep C while treating ICU patients. Upon leaving the medical profession and entering into a five year glamorous but exhausting journey into the world of entertainment, she suddenly fell ill. She is now a strong voice for Hepatitis C awareness, ambassador for further research and education of the benefits of positive thinking to help the recovery process. It’s important to highlight that the CDC is recommending that everyone born during 1945 through 1965, also known as baby boomers, get a blood test for Hepatitis C. If you are a baby boomer the CDC recommends a one-time test. In addition, other articles of interest in this issue are; “The Importance of Our Microbiome,” “The Role of Specialty Pharmacy at Gastro Health” and “NonAlcoholic Fatty Liver Disease (NAFLD).” As we are at the midpoint of 2016, we are continuing our strategy of growth at Gastro Health, not only providing outstanding medical care and an exceptional healthcare experience, but also identifying opportunities to improve services for you and your family. Thank you for your unwavering confidence. We hope you have a safe and fun-filled summer. Alejandro Fernandez MBA, CMPE Chief Executive Officer
GH CLINICAL UPDATE by Jerry Martel, MD
Pages
4
13
BLOATING & SUCROSE INTOLERANCE: THE MISSING LINK by Enrique Hernandez-Sanchez, MD
14
PARTICIPATE IN CLINICAL RESEARCH & HELP MAKE A DIFFERENCE FOR THE FUTURE by Howard Schwartz, MD
19
THE IMPORTANCE OF OUR MICROBIOME by Paul G. Fishbein, MD
20
NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD) by Somal S. Shah, MD
22
THE ROLE OF THE SPECIALTY PHARMACY by Katiuska Iglesias, PharmD
24
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SUMMER 2016 ISSUEGASTRO MAGAZINE
Naomi Judd: Singer, Songwriter and Survivor
N
her
aomi Judd has lived a successful life comprised of several careers, singing and songwriting making
name
synonymous
with
town in Kentucky, she went on to become a nurse at intensive care units in Nashville, Tennessee where it was routine to be stuck with needles or get bodily fluids on herself.
4
fame.
Originally a single mom from a small-
In 1984, Naomi made a decision to
Naomi’s symptoms came in the form
Initial treatment consisted of Interferon
leave the medical field and enter the
of exhaustion, headaches, nausea and
injections three times a week. Doctors
more glittery and glamorous world
muscle aches. She decided to visit one
advised the treatment would slow
of entertainment. She looked good
of the doctors she had known from
down the mutation and replication
and felt even better as she performed
years past and after an analysis was
of hepatitis C but not cure it. The
alongside her daughter and singing
told that her ALT/AST liver enzymes
side effects were off-putting and
partner Wynonna Judd. Together they
were a little elevated. The doctor made
comparable to a having a severe
went on several tours and sang at
nothing serious of it, as he believed
flu. There were times Naomi was
the Super Bowl halftime, the London
that her strenuous lifestyle was most
so weak she couldn’t even get out
Palladium,
Garden
likely the cause. But knowing herself
of bed or change her clothes. With
and even Carnegie Hall. They sold
and her body very well, Naomi knew
unwavering
20 million records, made 15 #1 hits
something was off. It was then that
continued treatment even when the
and received more than 60 awards
the head of her record label made an
hepatits C seemed to outwit the
including six Grammys and seven CMA
appointment for her at the Mayo Clinic
Interferon. Within a matter of time a
Vocal Group of the Year trophies. They
where it was concluded that she had
newer version of the medication was
were unstoppable for five years until
contracted Hepatitis C, most possibly
released, and in 1995 Naomi received
1989, when Naomi started losing her
from an infected needle while working
the call she had been waiting for and
energy at a drastic rate.
as a nurse. She was given three years
was told she was completely cured.
Madison
Square
determination
she
to live and was forced to say goodbye to her fans.
The experience changed her life and led her to become an advocate of
“I’m radiantly healthy and happier than ever, and I’m using my restored energy to help others learn about themselves.”
health and wellness as a form of selfempowerment. In 2004 she published a New York Times bestseller “20 Choices to Transform Your Life,” and in 2008, “Naomi’s Guide to Aging Gratefully: Facts, Myths, and Good News for Boomers.” She has also had her own docu-series on OWN, the Oprah Winfrey Network, and her own radio show “Think Twice” on SiriusXM radio series.
By Michelle Menendez
5
I AM TO BE
URED
In clinical studies, 96–99% of patients with genotype 1 who had no prior treatment were cured with just 12 weeks of therapy.*
* In a study of 865 patients with genotype 1 Hep C and no prior Hep C treatment, with or without advanced liver disease (cirrhosis), 99% (210 out of 213) of those who received HARVONI once daily for 12 weeks were cured. In a separate study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 96% (208 out of 216) of those who received HARVONI once daily for 12 weeks were cured. † In the study of 647 patients with genotype 1 Hep C, with no prior Hep C treatment and without cirrhosis, 97% (119 out of 123) of those with lower levels of the virus (less than 6 million IU/mL) who received HARVONI once daily for 8 weeks were cured. These studies did not include patients with liver failure or those who have had a liver transplant. ‡ Based on prescription data for U.S. patients starting Hep C treatment with advanced treatment regimens (including direct-acting antiviral medicines) from 5/2011–12/2015. ∂
TODAY THERE’S HARVONI. A BREAKTHROUGH TREATMENT FOR HEPATITIS C. Now, more people have been prescribed HARVONI to cure their Hep C than any other advanced treatment regimen.‡ HARVONI is a prescription medicine used with or without ribavirin to treat chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 4, 5 or 6 infection. It is not known if HARVONI is safe and effective in children under 18 years of age. HARVONI has been proven to cure up to 99% of patients with genotype 1 (the most common type of hepatitis C) who’ve had no prior Hep C treatment.* HARVONI transformed Hep C treatment as the first cure that’s one pill, once a day for 12 weeks. And for certain patients with genotype 1, HARVONI has been shown to be highly effective in as little as 8 weeks of treatment.† Your Hep C Specialist will decide what treatment length is right for you. Cure means the Hep C virus is not detected in the blood when measured three months after treatment is completed. With HARVONI, there’s no interferon and no complicated regimens. So, if you don’t want to live with the uncertainties of Hep C, now may be the time to talk to your Hep C Specialist about HARVONI.
IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider before taking HARVONI? • If you have: liver problems other than hepatitis C infection, or have had a liver transplant; severe kidney problems or are on dialysis; HIV, or any other medical condition; or if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if HARVONI will harm your unborn baby or pass into your breast milk. If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information. • Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. HARVONI and certain other medicines may affect each other, or may cause side effects. Tell your healthcare provider if you take any medicines containing tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®). What are the possible side effects of HARVONI? • HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause serious side effects, including slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: fainting or near-fainting, dizziness or lightheadedness, not feeling well, weakness, extreme tiredness, shortness of breath, chest pains, confusion, or memory problems. • The most common side effects of HARVONI include tiredness, headache and weakness. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Are you ready for HARVONI? Ask your Hep C Specialist if HARVONI is right for you and visit HARVONI.com or call 1-844-READY41. Please see Important Facts about HARVONI on the following page.
THE ONE YOUíVE BEEN WAITING FOR
IMPORTANT FACTS
(har-VOE-nee) ABOUT HARVONI
BEFORE TAKING HARVONI
HARVONI is a prescription medicine used with or without ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1, 4, 5 or 6 infection in adults. It is not known if HARVONI is safe and effective in children under 18 years of age.
Tell your healthcare provider if you have: • Liver problems other than hepatitis C infection • Had a liver transplant • Severe kidney problems or you are on dialysis • HIV infection • Any other medical condition Tell your healthcare provider about all the medicines you take: • Keep a list that includes all prescription and over-thecounter medicines, vitamins, and herbal supplements, and show it to your healthcare provider. • Including any medicines containing tenofovir disoproxil fumarate (ATRIPLA®, COMPLERA®, STRIBILD®, TRUVADA®, VIREAD®). • If you take HARVONI with ribavirin, you should also read the ribavirin Medication Guide for important pregnancy-related information.
POSSIBLE SIDE EFFECTS OF HARVONI HARVONI, when taken with amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems, may cause serious side effects, including slow heart rate, which in some cases has led to death or the need for a pacemaker. Get medical help right away if you take amiodarone with HARVONI and get any of the following symptoms: • fainting or near-fainting • dizziness or lightheadedness • not feeling well • weakness • extreme tiredness • shortness of breath • chest pains • confusion • memory problems The most common side effects include tiredness, headache and weakness. These are not all the possible side effects of HARVONI. Tell your healthcare provider if you have any new symptoms while taking HARVONI.
∂
This is only a brief summary of important information about HARVONI and does not replace talking to your healthcare provider about your condition and your treatment.
HARVONI and certain medicines may affect each other, or cause side effects.
GET MORE INFORMATION • This is only a brief summary of important information about HARVONI. Talk to your healthcare provider or pharmacist to learn more. • Go to HARVONI.com or call 1-844-READY41 • If you need help paying for your medicine call 1-855-7-MYPATH or go to HARVONI.com/support
Retail Pharmacy prescription data from IMS NPA New to Brand™ U.S. patient starts between 5/2011 and 12/2015. HARVONI, the HARVONI logo, COMPLERA, STRIBILD, TRUVADA, VIREAD, GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners. ©2016 Gilead Sciences, Inc. All rights reserved. HVNC0516 03/16
PHYSICIAN DIRECTORY
SUMMER 2016 ISSUEGASTRO MAGAZINE
Francisco J. Baigorri, MD * Gastroenterologist
Simon Behar, MD * Gastroenterologist
Barry E. Brand, MD Gastroenterologist
Gustavo Calleja, MD * Gastroenterologist
Marc S. Carp, MD Gastroenterologist
CC1
CC3
CC2
CC1
CC6
Lewis R. Felder, MD Gastroenterologist
Edward Feller, MD Gastroenterologist
Jose P. Ferrer Jr., MD * Gastroenterologist
Jose P. Ferrer Sr., MD * Gastroenterologist
Paul G. Fishbein, MD Gastroenterologist
CC7
C C15
CC3
CC3
C C18
Nelson Garcia Jr., MD * Gastroenterologist
Pamela L. Garjian, MD* Gastroenterologist
Daniel Gelrud, MD * Gastroenterologist
Carla Ginsberg, MD Gastroenterologist
Harris I. Goldberg, MD Gastroenterologist
CC8
C C16
CC1
CC1
CC1
Ruben Gonzalez-Vallina, MD * Pediatric Gastroenterologist
Pedro J. Greer Jr., MD * Gastroenterologist
Mitchell Gregg, MD Radiologist, Imaging Center
Guillermo Gubbins, MD * Gastroenterologist
CC1
C C13
C C11
Alfredo J. Hernandez, MD * Gastroenterologist
Enrique Hernandez-Sanchez, MD*
Pediatric Gastroenterologist
Eugenio J. Hernandez, MD * Gastroenterologist
Moises E. Hernandez, MD * Gastroenterologist
Richard E. Hernandez, MD * Gastroenterologist
CC11
C C14
CC3
CC3
CC5
John Ibarra, MD* Radiologist, Imaging Center
Raghad Koutouby, MD Pediatric Gastroenterologist
Eduardo Krajewski, MD * Colorectal Surgeon
Vicente Lago, MD * Gastroenterologist
Robert C. Lanoff, MD * Gastroenterologist
C C12
CC9
C C19
CC2
Roberto Gonzalez, MD * Gastroenterologist
10
CC10
Jose A. Lavergne, MD * Gastroenterologist
James S. Leavitt, MD Gastroenterologist
Marc Lederhandler, MD Gastroenterologist
Oscar Loret de Mola, MD * Pediatric Gastroenterologist
CC7
CC1
CC1
C C17
Jerry Martel, MD, MPH * Gastroenterologist
Curtis L. McCarty III, MD Pathology Director
Flavia Mendes, MD * Gastroenterologist
Pedro Morales, MD * Gastroenterologist
Brett R. Neustater, MD Gastroenterologist
CC1
CC8
CC7
Gabriel Rodriguez, MD * Anesthesiologist
CC8
Irit Ludin-Ullman, MD* Anesthesiologist
Khristian Noto, MD * Colorectal Surgeon
Javier L. Parra, MD * Gastroenterologist
Rodolfo Pigalarga, MD* Colorectal Surgeon
Alfredo Rabassa, MD * Gastroenterologist
CC9
CC1
CC9
CC1
Andres I. Roig, MD * Gastroenterologist
Ricardo J. Roman, MD * Gastroenterologist
Jorge A. Rosario-Mulinelli, MD*
Pediatric Gastroenterologist
Seth D. Rosen, MD Gastroenterologist
Neil E. Rosenkranz, MD Gastroenterologist
CC3
CC7
C C14
CC2
CC2
S. Lawrence Rothman, MD Gastroenterologist
Eduardo Ruan, MD * Gastroenterologist
Andrew I. Sable, MD Gastroenterologist
George A. Sanchez, MD * Gastroenterologist
Howard I. Schwartz, MD Gastroenterologist
CC1
CC1
CC2
CC1
CC1
Somal S. Shah, MD * Gastroenterologist
Jason Slate, MD * Gastroenterologist
Arie Slomianski, MD * Gastroenterologist
Marcos Szomstein, MD * Colorectal Surgeon
Stefania L. Vernace, MD Gastroenterologist
C C11
C C11
CC1
CC9
CC1
* Habla EspaĂąol
11
Allied Healthcare Staff
Yamila Akmuradova PA-C * Care Center 11
Darlene Boytell-Perez, ARNP* Care Center 1
Carol Hernandez, PA-C Care Center 1
Jessica Jairala, PA-C * Care Center 1
Sabrina Kaplan, PA-C * Care Center 1
Rebecca Karousatos,MS,RD,LDN Care Center 1 & 2
Katiuska Iglesias, Pharm D * Specialty Pharmacy Manager
Ellen Matas-Sosa, PA-C Care Center 1
Jose A. Miguel, PA-C * Care Center 1
Ronal R. Ricano, PA-C * Care Center 11
Yetzabel Rizo, ARNP * Care Center 1
Eugenia Riccombeni, RD, LDN* Care Center 3
Noe Tacoronte, PA-C * Care Center 1
Kayce Tugg, MSN, RN Imaging Center
SUMMER 2016 ISSUEGASTRO MAGAZINE
* Habla EspaĂąol
Care Centers Care Center 1 Main Office 7500 SW 87 Avenue, Suite 200 Miami, FL 33173 305-913-0666
Care Center 8 8200 SW 117 Avenue, Suite 110 Miami, FL 33183 305-274-5500
Care Center 16 8353 SW 124 Street, Suite 108 Miami, FL 33156 305-669-1115
Care Center 2 9555 N. Kendall Drive, Suite 100 Miami, FL 33176 305-273-7319
Care Center 9 7765 SW 87 Avenue, Suite 212 Miami, FL 33173 305-596-3080
Care Center 17 7775 SW 87 Avenue, Suite 120 Miami, FL 33173 305-274-8243
Care Center 3 8950 N. Kendall Drive, Suite 306-W Miami, FL 33176 305-596-9966
Care Center 10 475 Biltmore Way, Suite 207-A Coral Gables, FL 33134 305-662-6170
Care Center 18 8950 N. Kendall Drive, Suite 506W Miami, FL 33176 305-595-2710
Care Center 4 15955 SW 96 Street, Suite 307 Miami, FL 33196 305-468-4191
Care Center 11 3661 S. Miami Avenue, Suite 805 Miami, FL 33133 305-856-7333
Care Center 19 351 NW 42nd Avenue, Suite 305 Miami, FL 33126 305-541-1041
Care Center 5 7765 SW 87 Avenue, Suite 105 Miami, FL 33173 305-274-0808
Care Center 11 Satellite Office Florida International University 885 SW 109 Avenue, Suite 131 Miami, FL 33199 305-856-7333
Imaging Center 7500 SW 87 Avenue, Suite 202 Miami, FL 33173 305-468-4190
Care Center 6 1400 NE Miami Gardens Drive, Suite 221 Care Center 12 8525 SW 92nd Street, Suite C-11A North Miami Beach, FL 33179 Miami, FL 33156 305-949-2020 305-512-3345 Care Center 7 Main Office Care Center 13 16855 NE 2nd Avenue, Suite 202 9260 SW 72 Street, Suite 217 North Miami Beach, FL 33162 Miami, FL 33173 305-770-0062 305-271-7330 Care Center 14 Care Center 7 Satellite Office #1 9980 Central Park Blvd N., Suite 316 5803 NW 151 Street, Suite 105 Boca Raton, FL 33428 Miami Lakes, FL 33014 561-206-6064 305-770-0062 Care Center 7 Satellite Office #2 21110 Biscayne Blvd, Suite 206 Aventura, FL 33180 305-770-0062 12
Insurances
Care Center 15 8353 SW 124 Street, Suite 203 Miami, FL 33156 305-259-8720
Pathology Laboratory 12485 SW 137 Avenue, Suite 103 Miami, FL 33186 305-468-4194 Specialty Pharmacy 7500 SW 87 Avenue, Suite 202 Miami, FL 33173 305-468-4199
AARP Medicare Complete Aetna American Heritage Life Insurance American Medical Security AvMed Baptist Executive Health Baptist International Beech street BHQN Blue Cross Blue Shield Care Plus (Colorectal only) Cigna Coventry Health Care Dimensions Health First Health Network Healthcare of Florida Healthease of Florida HealthSun Health Plans Humana Humana Champus Tricare Leon Medical Center (Colorectal only) Magellan Healthcare Mail Handlers Benefit Plans Medica Health Plan Medicare Part B Molina Healthcare MultiPlan Neighborhood Health Plan Preferred Care Partners Prestige Health Choice Simply Healthcare Sunshine Health United Healthcare Wellcare / Staywell Only accepted at our Pediatric Care Centers
BY Jerry Martel, MD, MPH Gastroenterologist
GH Clinical Update
W
as that great or what?! For
interest of the patient, and in the most
those of you who may not
efficacious
know what I am talking about,
it be in the realm of obesity, fecal
I am referring to the GH Clinical Update
incontinence, biliary disease, or even
that was held March 2016 at the Biltmore
transplantation).
Hotel. Three years since its revival, this year’s conference exceeded even my own lofty expectations. After hearing all the comments and reading all the reviews from the previous year, the necessary adjustments were made to provide a very informative, current and useful conference that hopefully made an immediate impact on patient care.
But
the
way
possible
proverbial
(whether
fun
and
improvements did not stop t h e r e . We
increased our venue size to
accommodate both the increasing number of participants as well as the vendors who so graciously were a part of our event. Ample time was provided to relax during breaks, catch up with old colleagues and forge new
This year, most of our speakers were
relationships while becoming informed
able to bring something new to typical
about all the latest medications, tests
conference talks and one of my favorite
and medical devices to provide 21st
additions was the “Conference to Clinic”
century care to our patients.
slide. Everyone listens to the talks and we all take away what we consider to be our own personal “nibble” of medical information we did not know, but applying it in a practical way isn’t so easy at times. This takeaway slide written by the speakers themselves provided participants with the practical “meat” of the talk, making it easier for the
Yet our work is never done. As you read this, we are already working towards an even better GH Clinical Update for next year. Mark your calendars, save the date and bring a friend because I expect to see all of you at the next conference on February 25, 2017. See you then!
information to be brought into practice. Also, this year’s agenda brought many of our GI issues to light through the eyes of our closest colleagues, surgeons. While many of the talks have been predominantly presented by GI’s, the real world surgical application of many of the issues we face also need to be in the forefront of our decision making. Very important points were made as to the involvement of a surgical opinion, as well as the timing of when to obtain that opinion, so as to act in the best 13
BY Enrique Hernandez-Sanchez, MD Pediatric Gastroenterologist
Bloating and Sucrose Intolerance: The Missing Link
B
SUMMER 2016 ISSUEGASTRO MAGAZINE
loating, or the feeling or having a distended abdomen full of gas, is an extremely common complaint heard in gastroenterology offices, by pediatricians and family medicine doctors. Many diseases can cause bloating and doctors are relatively proficient at detecting potential causes of this condition such as (Celiac disease, lactose intolerance and bacterial overgrowth), but in many cases the tests yield negative results. Eventually, many patients are labeled as having “irritable bowel syndrome� (IBS) and are prescribed generic treatments that include probiotics, antispasmodics or peppermint oil. Yet many times they do not improve and continue to suffer from their symptoms. Up to 40% of patients with IBS actually suffer from sucrose intolerance, formally known as genetic sucrase-isomaltase deficiency, or GSID. Sucrose is formed when the sugars glucose and fructose bind together. In order to break this bond, humans need the presence of an enzyme called sucrase, which is present in the lining of small bowel. Unfortunately, many children are born with a reduced amount of this enzyme and the result is that sucrose is not absorbed and continues traveling down the bowel. This pulls water from the intestinal lining cells (causing diarrhea and cramps) and when it eventually reaches the large intestine, the bacteria ferments the sugar and forms hydrogen gas, which leads to bloating. 14
Unless your physician orders a sucrose breath test, or disaccharides analysis (a test from tissue obtained during an upper endoscopy which is the best way to diagnose sucrose intolerance), you will probably remain undiagnosed for a long time.
which contains the actual missing enzyme, sucrose.
The most frustrating thing of all is that effective therapy is available. Treatment begins with a restriction of sucrose in your diet (which is present in certain fruits, juices, sugar cane, syrups, honey and candy), adding a probiotic containing saccharomyces boulardii (Florastor) and for most patients, a medication called Sucraid,
If you, your family or friends suffer from bloating, ask your physician to
Patients usually will add 1-2ml of Sucraid to each meal or snack that contains sucrose to prevent the development of symptoms.
be tested for this very common, but frequently missed condition!
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IN A COMPETITIVE ENVIRONMENT
At Brown & Brown, we know that we must be as agile as the cheetah in order to thrive in the competitive insurance environment. Brown & Brown is one of the largest and most respected independent insurance intermediaries in the nation, with over 70 years of continuous service and more than 275 locations. Some of our services include: Business Insurance Employee Benefits • Personal Insurance • •
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date night.
dinner party.
If other treatments haven’t worked well enough, ask your gastroenterologist about ENTYVIO.® Uses of ENTYVIO® (vedolizumab): ENTYVIO is a prescription medicine used in adults: • With moderate to severe ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, induce and maintain remission, reduce or stop the use of corticosteroids, and improve the way the lining of your large intestine looks to your healthcare provider. • With moderate to severe Crohn’s disease (CD) when certain other CD medicines have not worked well enough or cannot be tolerated. ENTYVIO may help to: begin reducing some symptoms, achieve remission, and reduce or stop the use of corticosteroids.
Important Safety Information about ENTYVIO® • Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients. • ENTYVIO may cause serious side effects, including: • Infusion and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you
have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash; itching; swelling of your lips, tongue, throat or face; shortness of breath or trouble breathing; wheezing; dizziness; feeling hot; or palpitations (feel like your heart is racing). • ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. • Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML, which can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms:
ENTYVIO is a trademark of Millennium Pharmaceuticals, Inc., registered with the U.S. Patent and Trademark Office, and is used under license by Takeda Pharmaceuticals America, Inc. © 2016 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved.
Printed in U.S.A./June 2016 USD/VED/15/0279c
the big game.
Moderate to severe UlCeratIve ColItIs or Crohn’s syMptoMs leaving you with the saMe view? it may be time for a different perspective.
• DevelopeD only for UC anD Crohn’s • GI-foCUseD • proven to provIDe relIef anD remIssIon Individual results may vary.
confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. • Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice). • The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed. Please see the Medication Guide for ENTYVIO on the adjacent page and talk with your healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB)
Learn more at ENTYVIO.com
Relief and Remission within reach.
Medication Guide ENTYVIO (en ti' vee oh) (vedolizumab) What is the most important information I should know about ENTYVIO? ENTYVIO may cause serious side effects, including: • Infusion and serious allergic reactions. These reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing). • Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination. • Progressive Multifocal Leukoencephalopathy (PML). Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision. • Liver Problems. Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice). See “What are the possible side effects of ENTYVIO?” for more information about side effects. What is ENTYVIO? ENTYVIO is a prescription medicine used in adults: • with moderate to severe active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated: ° to begin helping some of your symptoms ° in people who respond to ENTYVIO, to help get UC under control (induce remission) and keep UC under control (maintain remission) ° for people who respond to ENTYVIO, you may be able to reduce or stop the use of corticosteroid medicines ° to improve the way the lining of your large intestine looks to your healthcare provider during colonoscopy • with moderate to severe active Crohn’s disease when certain other Crohn’s disease medicines have not worked well enough or cannot be tolerated: ° to begin helping some of your symptoms ° in people who respond to ENTYVIO, to help get Crohn’s disease under control (achieve remission) ° for people who respond to ENTYVIO, you may be able to reduce or stop the use of corticosteroid medicines It is not known if ENTYVIO is safe and effective in children under 18 years of age. Who should not receive ENTYVIO? Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of the ingredients in ENTYVIO. See the end of this Medication Guide for a complete list of ingredients in ENTYVIO.
Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: • have an infection, think you may have an infection or have infections that keep coming back (see “What is the most important information I should know about ENTYVIO?”). • have liver problems • have tuberculosis (TB) or have been in close contact with someone with TB. • have recently received or are scheduled to receive a vaccine. Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with ENTYVIO. • are pregnant or plan to become pregnant. It is not known if ENTYVIO will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving ENTYVIO. • are breastfeeding or plan to breastfeed. It is not known if ENTYVIO passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take or have recently taken Tysabri (natalizumab), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine. How will I receive ENTYVIO? • ENTYVIO is given through a needle placed in a vein (intravenous infusion) in your arm. • ENTYVIO is given to you over a period of about 30 minutes. • Your healthcare provider will monitor you during and after the ENTYVIO infusion for side effects to see if you have a reaction to the treatment. What are the possible side effects of ENTYVIO? ENTYVIO may cause serious side effects, See “What is the most important information I should know about ENTYVIO?” The most common side effects of ENTYVIO include: common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all of the possible side effects of ENTYVIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about ENTYVIO Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about ENTYVIO that is written for health professionals. Do not use ENTYVIO for a condition for which it was not prescribed. What are the ingredients in ENTYVIO? Active ingredient: vedolizumab Inactive ingredients: L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose and polysorbate 80 Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015 U.S. License No. 1898 For more information, go to www.ENTYVIO.com or call 1-877-825-3327 This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: May 2014 ENTYVIO is a trademark of Millennium Pharmaceuticals Inc. and is used under license by Takeda Pharmaceuticals America, Inc. All other trademark names are the property of their respective owners. ©2014 Takeda Pharmaceuticals America, Inc. VMB245 R1_CFBS L-BZV-0514-4
BY Howard Schwartz, MD, AGAF Gastroenterologist
Participate in Clinical Research and Help Make a Difference for the Future
G
astro Health offers an opportunity to participate in clinical trials for new medications. By volunteering to participate, our patients can help others by contributing to medical research. Our physicians have participated in the development of many important products for the treatment of gastrointestinal conditions. For example, our team has been involved in the clinical trials for Remicade, Humira, Amitizia, Lialda, Asacol, Osmoprep, Harvoni and Sovaldi. Today, all new drugs or medical devices need to go through extensive testing prior to being approved for use by patients. In order to come to the market a medication or device needs to go through preclinical trials, which are used to evaluate the safety and potential effectiveness in experimental models. If the drug or device seems promising, it then goes into clinical testing, which consists of the following four phases. PHASE 1 These studies determine the safety and dosing schedule in healthy volunteers who generally have no medical issues and are paid to take the drug in order to evaluate its safety.
be asked to sign an informed consent approved by an Independent Review Board (IRB) that approves the conduct of the study and make sure it conforms to the principles of the Declaration of Helsinki and FDA guidelines. For further details you can visit www.fda.gov.
PHASE 2 These studies involve between 150 – 400 subjects to determine if a drug works for a specific condition and to gather additional safety data.
An informed consent is required to provide you with the following information:
PHASE 3 These studies are considered pivotal in the approval process. They involve from 500-3000 subjects and are what is generally used by the FDA and other government agencies to see if a drug works for a specific disease and if it is safe to use.
How long the study will last and the number and frequency of visits required.
PHASE 4 These studies generally are used to evaluate the safety of a medication after it has been approved to go on the market. Before participating in a clinical trial you will
The purpose of the study.
Procedures and tests that may be required by participating in the study. The potential risks and benefits of study medication.
If there is a chance that subjects participating in a study receive a placebo. Who will have access to your medical records. Who will pay for medical care if you are injured in the study. Awareness that as a research volunteer you can stop your participation at any time without bias. We are currently conducting a clinical trial comparing Humira to Entyvio in patients with ulcerative colitis. If you would like further information please contact Dr. Howard Schwartz or Karla A. Gonzalez, MA, CCRC at 305-913-0666 ext 1360.
Other treatment options that may be available. 19
BY Paul G. Fishbein, MD, FACP, AGAF Gastroenterologist
SUMMER 2016 ISSUEGASTRO MAGAZINE
The Importance of Our Microbiome ne of the most fascinating recent
tract. In fact, it is estimated that our
in our gut but do not affect our health
developments in medicine is our
gut contains over ten trillion microbes,
in any meaningful way. Many others,
discovery of the importance of
most of which reside in our colon. These
however, are symbionts. These not only
the microbiome in health and disease.
include
bacteria,
grow and multiply within our digestive
What is this microbiome and how does
but also fungi, viruses and protozoa.
tract, but also provide benefits to us by
it affect our lives?
These microorganisms comprise the
assisting in digestion and promoting a
microbiota and their genetic material is
healthy immune status to maintain our
called the microbiome.
good health. Finally, there are microbes
Over the last few years researchers
vast
numbers
of
have begun to discern the role of the
that are pathobionts. These invade our
microbiome in maintaining health and
The
microbiota
has
evolved
in
a
gut and lead to various infections such
its alteration in causing many illnesses.
Darwinian fashion to relate to us—their
as traveler’s diarrhea, gastroenteritis
It is well known that we harbor many
host—in various ways. Most live as
or colitis. But they can also cause or
microorganisms within our digestive
commensals. These organisms thrive
aggravate many systemic diseases. The intestinal microbiota is intimately involved with the maturation of our gut after birth. Experiments in mice have demonstrated that altered microbiota may have a detrimental effect on the intestinal surface, lymphoid function, motility,
metabolic
processes
and
mucosal immunity of our digestive tract. Normally, these microorganisms defend us against pathogens. They assist in energy utilization and the digestion and absorption of nutrients. They also play an important role in drug metabolism. However,
when
the
microbiome
is
altered, a dysbiosis develops. When this occurs, a derangement in the number and kind of microbiota leads to various diseases. Small bowel bacterial overgrowth, Clostridium difficile colitis, inflammatory bowel disease and irritable bowel syndrome are prime examples that have been shown to be affected and perhaps caused by this dysbiosis. Even chronic constipation has been attributed to an altered microbiome.
20
Moreover, malignancies both within the gut and in other parts of our bodies have been linked to alterations in our microbiome. One example of this is the development of gastric cancer from chronic Helicobacter pylori infection. Importantly, many other serious illnesses are also associated with this modification in our gut flora. These include: arthritis, asthma, autism, diabetes mellitus, fibromyalgia, coronary heart disease, metabolic syndrome, mood disorders, fatty liver disease and even such neurologic diseases such as multiple sclerosis and Parkinson’s disease. Obesity itself has also been said to be a product of this dysbiosis. It has been demonstrated that antibiotic use in infants prior to age two contributes to obesity in later life. Experiments in mice have confirmed this observation. It is well known that chronic irritable bowel syndrome can follow an attack of acute gastroenteritis. It is possible that change in the microbiota alters the normal function of the bowel to affect motility and visceral sensitivity. Once this process occurs, it may be difficult to correct. Current studies suggest a possible role for probiotics in preventing and treating this illness. Ironically, the tremendous medical and scientific advancements of the 20th century in understanding and treating diseases, such as the use of antibiotics and better sanitation, have possibly led to causing new illnesses or aggravating other pathologic conditions. We have disturbed the unique balance of symbiosis with
our
microbiota
which
nature
created
over
millennia. Now, the 21st century holds out the promise to cure or prevent many of these diseases by identifying and correcting alterations in our microbiome. We are learning about the effects on our macro or external environment
from
manufacturing and pollution in causing global warming. It is our task to discover more about the relationship with our microbiome and how it affects our lives and health. Antibiotics, other medications and even the processed foods we eat have disrupted and damaged our micro or internal environment. Nature rewards diversity. Just as a nation, political party or financial portfolio is stronger with diversity, so too is our microbiome. We must find ways of reversing this change in order to enhance our long term health. This challenge of restoring the balance of our microbiome is one of the most important ones facing us today.
21
BY Somal S. Shah, MD Gastroenterologist
Non-Alcoholic Fatty Liver Disease (NAFLD)
N
AFLD
is
common
an
increasingly
chronic
disease
of the liver. This condition
occurs in patients who have developed fat in their liver (steatosis) and in patients who have developed a chronic SUMMER 2016 ISSUEGASTRO MAGAZINE
inflammation or scarring of the liver (fibrosis). The presence of both fat and fibrosis in the liver is called nonalcoholic steatohepatitis
(NASH).
NAFLD
has
been reported to be present in around 45% of the U.S. population, while NASH is seen in 5%. NAFLD is especially more common in patients who also have been diagnosed with diabetes, obesity and high cholesterol. NAFLD does not present with any typical symptoms as it’s usually discovered incidentally in patients with elevated liver function tests or through imaging tests done for other reasons. The most common imaging test is an abdominal ultrasound, while an MRI is the most accurate imaging test to detect NAFLD. Until recently, the only way to both diagnose and assess the severity of liver fibrosis was through a liver biopsy. However, there is a new type of ultrasound called a liver elastrography that uses sound waves against the liver to accurately determine the extent of liver fibrosis. In addition, there are blood tests such as the Fibrosure test that can accurately calculate a fibrosis score. The diagnosis of NASH is important because if untreated it can lead to major complications including hepatocellular carcinoma, liver cirrhosis and possible death. The main lifestyle modifications to treat NASH include aggressive weight loss and avoiding both alcohol and
22
medications that can be toxic to the liver (such as excessive amounts of Tylenol). The main option in terms of medical treatment is vitamin E which works to decrease the inflammation caused by the presence of fat in the liver. For patients with both diabetes and NASH, the treatment of choice is a class of diabetes drugs called thiazolidinediones. Excess weight loss remains far superior to medications in treating NASH. In fact, many patients are cured from NASH after having weight loss surgery such as a gastric bypass. Since obesity is likely to become even more common in the future, there is no doubt that NASH and its complications will become increasingly problematic as well.
Galloway Endoscopy Center is an accredited surgical facility offering diagnostic and therapeutic gastrointestinal procedures in a comfortable and convenient outpatient setting. Our compassionate, bilingual staff provides top-quality care while assisting our experienced and highly skilled doctors. Best of all, because of advances in medical technology, endoscopic procedures can be safely performed outside the hospital, so you can return to the comfort of your home the same day as your procedure. You have a choice in healthcare. Isn’t it time you got treated better ?
A division of Baptist Surgery and Endoscopy Centers 7500 SW 87 Avenue, Suite 101 Miami GallowayEndoscopy.com 305-595-9511 A n o t - for- profi t o rga nization supported by philanthropy and com m itted to our faith-based charitable m ission of m ed ical excellence
BY Katiuska Iglesias, Pharm D Specialty Pharmacy Manager
The Role of the Specialty Pharmacy
T
he advent of specialty pharmacies began roughly 30 years ago and continues to be a major player in
the healthcare system today. These types of pharmacies focus on highly specialized medication therapy for patients with complex diseases such as hepatitis C, SUMMER 2016 ISSUEGASTRO MAGAZINE
inflammatory bowel diseases and cancer to name a few. As the name implies, the medications filled at these types of pharmacies require an escalated level of clinical attention involving ongoing monitoring, patient education and patient management by well qualified clinical staff. They often times require special handling and storage, as well as specific administration
requirements
such
as
injections or infusions. This complexity drives the cost of the medication up, which oftentimes can exceed $10,000 annually for certain therapies. All of these factors lend to the need for a more focused practice of a pharmacy-
assistance to help cover the high copays
This integration allows the pharmacy staff
based-on-patients that encompasses all
that are often times associated with
all the critical patient information needed
aspects of the patient’s therapy. Specialty
these therapies. The financial assistance
to make appropriate clinical decisions as
pharmacies are specifically designed to
offered is personalized, detailed and
well as expedite all third party payer claim
manage complex patient therapies while
ranges from seeking manufacturer copay
requirements. Patients of Gastro Health
controlling drug spending and waste.
cards to applying for specific charitable
Specialty Pharmacy have the advantage
foundations that are crucial to patient
of having their multidisciplinary clinical
accessibility of these medications.
team working together to manage their
Additionally, specialty pharmacies offer services that go above and beyond
24
complex condition.
a traditional retail pharmacy. Making
Gastro Health Specialty Pharmacy is
sure patients have access to these
proud to be a part of this niche area of
Specialty pharmacy is a rapidly expanding
costly medications is of the utmost
pharmacy. In addition to all the services
field that has now grown to over 200
priority. Often times these pharmacies
that a specialty pharmacy provides,
pharmacies and is still growing. With the
have specific teams dedicated solely
Gastro Health Specialty Pharmacy is
advancement in medication therapy for
to patient financial assistance. These
unique in that it is a part of your Gastro
complex, rare and chronic conditions there
teams have extensive experience in
Health
The
is an obvious need for the specialized
obtaining
third
clinical pharmacy staff has direct access
services they provide. Specialty pharmacies
party payers as they are well-versed
to your healthcare provider and allied
will continue to meet the challenges of
in all the requirements needed to
staff members, as well as has access
this rapidly evolving field of healthcare.
obtain approvals. Moreover, they are
to patient records to provide a more
also experts in helping with financial
integrated approach to patient therapy.
authorizations
from
clinical
provider’s
team.
Colon cancer is the second-deadliest form of cancer in the U.S., yet it doesn’t have to be. Did you know that it’s 90 percent preventable? Screening is the key. Colon cancer stops with you This simple procedure – called a colonoscopy – can actively prevent colon cancer. Do it for you and your loved ones. If you are at-risk, get screened, and get on with your life! Who should get screened? Anyone 50 and older People who have a family history of polyps or colon or rectal cancer African-Americans who are 45 and older Other minority groups where the disease is more prevalent
Simon Behar, M.D. Jose P. Ferrer, Sr., M.D. Jose P. Ferrer, Jr., M.D. Nelson Garcia, Jr., M.D. Alfredo Hernandez, M.D. Eugenio J. Hernandez, M.D. Moises E. Hernandez, M.D. Jerry Martel, M.D. Seth D. Rosen, M.D. Andrew Sable, M.D. Galloway Surgery Center 7600 SW 87th Ave., Suite 100 Miami, FL 33173 Phone: 786-245-6100 www.gallowaysurgerycenter.com
To schedule your colon cancer screening, please call 786-245-6100
SUMMER 2016 ISSUEGASTRO MAGAZINE
ADDRESSING THE TOUGHEST CHALLENGES IN GASTROENTEROLOGY
TAKES ALL OF US For over a decade, we’ve worked closely with physicians, investigators, and patients to take on the toughest health challenges. We’re studying new indications to address significant unmet needs. Creating programs proven to improve patient outcomes. Investing in next-generation research to keep advancing the frontiers of patient care. We’re determined to keep making a difference in gastroenterology. That’s why you can count on our continuing commitment to you and your patients.
LEARN MORE AT ABBVIE.COM
PEOPLE. PASSION. POSSIBILITIES. ©2015 AbbVie Inc.
North Chicago, IL 60064
64E-1811604 November 2015 Printed in U.S.A.