Gh magazine summer 2016

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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9500 South Dadeland Boulevard Suite 200, Miami, FL 33156 T. 305.468.4180

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Copyright © 2015 Gastro Health, P.L. All rights reserved. This publication is published by Gastro Health, P.L., which is solely responsible for its contents. This information presented is intended only for residents of the United States. The material presented is intended only as informational, or as an educational aid, and it is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.

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Cover Photo Credit: Europa Press /Getty Images

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d hare, an Track, S

e Compar

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© Janssen Biotech, Inc. 2015 12/15 043635-151119

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

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CC1

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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

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C C15

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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

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C C16

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Ruben Gonzalez-Vallina, MD * Pediatric Gastroenterologist

Pedro J. Greer Jr., MD * Gastroenterologist

Mitchell Gregg, MD Radiologist, Imaging Center

Guillermo Gubbins, MD * Gastroenterologist

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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

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C C14

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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

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C C19

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Roberto Gonzalez, MD * Gastroenterologist

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Jose A. Lavergne, MD * Gastroenterologist

James S. Leavitt, MD Gastroenterologist

Marc Lederhandler, MD Gastroenterologist

Oscar Loret de Mola, MD * Pediatric Gastroenterologist

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CC1

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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

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Gabriel Rodriguez, MD * Anesthesiologist

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Irit Ludin-Ullman, MD* Anesthesiologist

Khristian Noto, MD * Colorectal Surgeon

Javier L. Parra, MD * Gastroenterologist

Rodolfo Pigalarga, MD* Colorectal Surgeon

Alfredo Rabassa, MD * Gastroenterologist

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CC1

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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

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C C14

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S. Lawrence Rothman, MD Gastroenterologist

Eduardo Ruan, MD * Gastroenterologist

Andrew I. Sable, MD Gastroenterologist

George A. Sanchez, MD * Gastroenterologist

Howard I. Schwartz, MD Gastroenterologist

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Somal S. Shah, MD * Gastroenterologist

Jason Slate, MD * Gastroenterologist

Arie Slomianski, MD * Gastroenterologist

Marcos Szomstein, MD * Colorectal Surgeon

Stefania L. Vernace, MD Gastroenterologist

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* 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!

THRIVE

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 • •

• Financial

Services Management • Reinsurance • Risk

305.444.8350 Direct Inquiries to Luis Quiñones lq@bentrust.com or Neil Verdeja nverdeja@bentrust.com

www.bbinsurance.com

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.