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Physicians Office Resource - June 2021

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Physicians office Resource 2021 | Issue 6

Resources for You, Your Patients, & Your Practice

MEN’S HEALTH:

How Small Steps Can Make a Big Impact

— PAGE 10 5 MUST-HAVES FOR GREAT PHYSICIAN ONLINE PROFILES | PAGE 28 DO YOUR PATIENT HAVE TO LIKE YOU | PAGE 36


PUBLISHED BY Medical Education Resources, LLC PUBLISHER Aaron R. Medaris amedaris@physiciansofficeresource.com

CEO Andrew C. Nimmo acnimmo@physiciansofficeresource.com

PRESIDENT John D. Pasquale jpasquale@pharmaconnect.com

Getting the most from this guide

BUSINESS MANAGER Marci J. Hills mhills@physiciansofficeresource.com

TRAVEL EDITOR Brandi L. Brower EDITORIAL BOARD Michael Paquin, FHIMSS Barry Craig, MLT (NCA), CLC STAFF WRITER Dylan J. Chadwick

There are two simple ways to request

CREATIVE DIRECTOR PRODUCTION MANAGER Jessica Peterson

information about the products and services

Copyright ©2021

found in Physicians Office Resource. 1. Go to www.PhysiciansOfficeResource.com and enter the four-digit reference number found next to the product or service into the search field, then request additional information, schedule a demo, or speak with a sales agent all with just a simple click of a button. 2. Find the Business Reply Card in this issue, circle the desired reference numbers, complete the form, and drop into any USPS mailbox. A representative will contact you as quickly as possible to answer your questions.

www.PhysiciansOfficeResource.com

2 | PHYSICIANS OFFICE RESOURCE

To continue your free subscription of Physicians Office Resource magazine, please fill out the Business Reply Card (BRC) located within this magazine and drop in any United States Post Office mailbox. If you are a manufacturer of medical products or provide services to medical professionals and would like to advertise your products or services to the nation’s top physicians doing in-office testing, call 801-380-6094 or visit: POR.io for more information.


POINT OF CARE

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M

9400

EHENS PR I M

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TRANSFORM PATIENT SATISFACTION AND PRACTICE EFFICIENCY.

AVA I L A

®

CLIA Waived Tests: CMP, BMP, Lipid Panel, Lipid Panel Plus, General Chemistry, Kidney Check, Renal Panel, MetLyte 8 and Electrolytes

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Fast—Results in minutes, accelerating patient care decisions. Accurate—Lab-accurate results for a wide range of tests.* Versatile—Comprehensive CLIA-waived menu available. Simple—Intuitive function to improve operational efficiency. Convenient—Have test results during office visit, increasing patient satisfaction.

To learn more, contact your Abbott Point of Care representative at 888-893-0335, your distribution representative, or visit www.pointofcare.abbott *2016 Proficiency Testing Results, American Proficiency Institute, www.api-pt.com [Piccolo Xpress]. See cartridge information at www.pointofcare.abbott [i-STAT]. i-STAT Part No: 04J60-20 Waived Kit, 04J48-50 Moderately Complex Kit, 06F20-20 Waived Analyzer, 04P75-03 Moderately Complex Analyzer Piccolo Xpress Part No: 07P05-50 Piccolo Xpress with 3YR Serv, 07P05-51 Piccolo Xpress with 5YR Serv ©Abbott Point of Care Inc. 400 College Road East, Princeton, NJ 08540 www.pointofcare.abbott For in vitro diagnostic use only. This material is intended for a U.S. audience only. i-STAT is a trademark of Abbott. 3032.REV1 07/20 POR Ad - Abbott POC i-Stat/Piccolo Piccolo Xpress is a registered trademark of Abaxis, Inc. and distributed by Abbott Point of Care. Abaxis 888-3355 Rev A


TABLE OF CONTENTS

MEN’S HEALTH: HOW SMALL STEPS CAN MAKE A BIG IMPACT

Men are facing a health crisis that is very preventable, but poor health habits, failure to seek medical attention and dangerous occupations lead men to live sicker lives and die sooner. For example, 75% of premature heart disease deaths are men; middle-aged men are twice as likely to have diabetes and each year, more than 230,000 men are diagnosed with prostate cancer and about 30,000 die from it.

PAGE 10

28

36

5 MUST-HAVES FOR GREAT PHYSICIAN ONLINE PROFILES

DO YOUR PATIENTS HAVE TO LIKE YOU?

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—

Patients have a lot of choices when it comes to physicians. Making sure your online profile is up to date, complete, and contains these five items will improve the chances that a website visitor will become a patient.

The service industry model, one which emphasizes customer service over all else, has bled into numerous other industries, including medicine, and nowhere is this more prevalent than the world of doctor rating sites.

4 | PHYSICIANS OFFICE RESOURCE


TO X I C O LO G Y S C R E E N I N G

SIMPLIFIED Comprehensive toxicology menu now with 14 CLIA1 categorized moderately complex assays.

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IMMTOX™ 270 BENCHTOP ANALYZER Toxicology screening solutions for physician offices, treatment centers and laboratories. n

25 assay menu

n

Up to 270 tests per hour

n

Compact footprint

n

Quality products, service and reliability

COMPLETE LABORATORY SOLUTIONS From consultation, to licensure and compliance, the Abbott Clinical Lab Solutions team has you covered.

CONTACT ABBOTT CLINICAL LAB SOLUTIONS. CALL 888-831-6850 | EMAIL: CLS_SALES@ABBOTT.COM 1. Clinical Laboratory Improvement Amendments (CLIA) © 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. MKT52247 REV1 08/20


PRODUCT FOCUS

CHEMISTRY ANALYZERS EASY, INTEGRATED WITH-PATIENT TESTING I-STAT SYSTEM Easy, Integrated With-Patient Testing From Abbott Point of Care i-STAT System from Point of Care at Abbott The handheld i-STAT System offers a broad menu of diagnostic tests

at the patient’sSystem side in just minutes. With justmenu a few drops of blood, The handheld i-STAT offers a broad of diagnostic tests at the the i-STAT System delivers real time, lab-accurate results for a wide patient’s side in just minutes. With just a few drops of blood, the i-STAT range of tests, including chemistries, blood gas, coagulation, cardiac markers, and time, more. Minimize delays and wastedfor timeawith on-side System delivers real lab-accurate results wide range of tests, tests. Easy, intuitive operation. including chemistries, blood gas, coagulation, cardiac markers, and more. 9403 For intended use and complete product information, pointofMinimize delays and wasted time with on-site tests.visit Easy, intuitive operation care.abbott.

For intended use and complete product information, visit pointofcare.abbott. For in vitro diagnostic use only. This material is intended for a U.S.

For in vitro diagnostic use only. This material intended for U.S. audience only. Office Reaudience only. i-STAT is aistrademark ofaAbbott. Physician i-STAT is a trademark of Abbott. Office Resource i-STAT Product Description – US 3064.REV1 08/20 source i-STAT Physician Product Description — US 3064.REV1 08/20

View Brochures, Videos & More at POR.io Enter Number 9403 in the Search Area

ENVOY500+ DELIVERING PROVEN RESULTS IN CLINICAL CHEMISTRY From EliTech The fully automated Envoy500+ is designed to deliver the performance of a large floor model analyzer but provides the cost efficiency of a benchtop analyzer (TPH approx. 490). It enables accurate treatment decisions sooner. Envoy500+ delivers savings the laboratory requires with the following features positive sample and reagent identification, clot detection, liquid level sensing, dry ISE module, reusable glass cuvettes, and many more.

View Brochures, Videos & More at POR.io Enter Number 9404 in the Search Area

9404

FULL COMPLEMENT OF CLIA-WAIVED

Full Complement of CLIA-waived Blood Chemistry Tests BLOOD CHEMISTRY TESTS PICCOLO ® Chemistry Analyzer from Abbott Piccolo Xpress

XPRESS® CHEMISTRY ANALYZER

Point of Careprovides physician offices with The Piccolo From XpressAbbott Chemistry Analyzer lab-accurateThe results for Xpress a broad range ofAnalyzer CLIA-waived general chemistry Piccolo Chemistry provides physician tests, including metabolic panels, lipids, kidney offices with lab-accurate resultsliver, for a and broad range function, of CLIA- and more general tests, panels, provides with just 100waived microliters of chemistry blood. Easy toincluding use, themetabolic Piccolo Xpress lipids, live, and kidney function, and more with just 100 results during a patient’s visit, accelerating treatment decisions, increasing microliters of blood. Easy to use, the PIccolo Xpress provides 9405efficiency, and supporting Automated quality control on results during apatient patient’ssatisfaction. visit, accelerating treatment decisions, every test helps ensure accuracy. increasing efficiency, and supporting patient satisfaction. Automated quality control on every test helps ensure accuracy.

For in vitro diagnostic use only. This material is intended for a U.S. audience only. Brochures, Videos &distributed More at POR.io Piccolo Xpress is aView registered trademark of Abaxis, Inc. and by Abbott Point of Care. Physician Office Resource Product9405 Description US 3065.REV1 Enter Piccolo Number in –the Search 08/20 Area

6 | PHYSICIANS OFFICE RESOURCE


Track down SARS-CoV-2 and 18 other bad bugs. The new BioFire® Respiratory 2.1-EZ (RP2.1-EZ) Panel1 covers COVID-19 detection in your clinic. SARS-CoV-2 is everyone’s top suspect, but many other respiratory bugs can cause similar, overlapping symptoms. In your clinic, you can test for 19 common respiratory pathogens, including SARSCoV-2, with the BioFire RP2.1-EZ Panel—now available under an FDA Emergency Use Authorization.1.2 Syndromic testing means all it takes is one test and about 45 minutes to round up SARS-CoV-2—and all the other usual respiratory suspects. Rapid answers on a broad range of pathogens can inform patient management and alleviate patients and staff alike. What’s your frontline solution into respiratory season and beyond?

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1. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 2. For use with the CLIA-waived BioFire® FilmArray® 2.0 EZ configuration.

BFR0001-0518-01

To learn more, visit biofiredx.com


COVID-19 TESTING PRODUCT FOCUS

BD VERITOR™ PLUS SYSTEM From BD Veritor™

9407

The BD Veritor™ Plus System is a portable, easy-to-use, testing solution for SARS-COV-2*, Flu A+ B and other respiratory tract infections that delivers results in 15 minutes or less. It features two analysis modes that adapt to your workflow, online education tools, and optional reporting capabilities including the BD Synapsys™ Informatics Solution—making it the point-ofcare diagnostic tool you won’t want to be without. *EUA authorized by FDA

View Brochures, Videos & More at POR.io Enter Number 9407 in the Search Area

BIOFIRE® RESPIRATORY 2.1-EZ (RP2.1-EZ)1 PANEL (EUA)1

From BioFire

9408

SARS-CoV-2 is everyone’s top suspect, but many other respiratory bugs can cause similar, overlapping symptoms. In your clinic, you can test for 19 common respiratory pathogens, including SARS- CoV-2, with the BioFire RP2.1-EZ Panel (EUA)1—now available under an FDA Emergency Use Authorization. Syndromic testing means all it takes is one test and just 45 minutes to round up SARS-CoV-2—and all the other usual respiratory suspects. 1. This test is not FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

View Brochures, Videos & More at POR.io Enter Number 9408 in the Search Area

FIRST EUA POINT-OF-CARE (POC/WAIVED/ FINGERSTICK) COVID-19 ANTIBODY TEST NOW AVAILABLE From Carolina Liquid Chemistries

9409

The Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Carolina Liquid Chemistries, has received FDA Emergency Use Authorization for use with fingerstick whole blood specimens at the point-of-care, i.e. in patient care settings operating under CLIA Certificate of Waiver such as doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab.Refer to carolinachemistries.com for instructions for use, fact sheets, FDA EUA letters, clinical performance studies, and material safety data sheets. Not FDA cleared; only for emergency use under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked.

View Brochures, Videos & More at POR.io Enter Number 9409 in the Search Area 8 | PHYSICIANS OFFICE RESOURCE


Why You Should Be Doing Spirometry

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9412 It’s Important - Spirometry is the gold standard for the diagnosis and management of both asthma and COPD. It’s Good Medicine - Your patients are correctly diagnosed and treated more accurately and conveniently in your office. The earlier you detect the disease; the easier you can treat it. It’s Easy - A spirometry test takes less than five minutes to perform. It’s Good Business - Office spirometry is third party reimbursable and will pay for itself within the first year of purchase. It’s Safe - The SpiroSafe filter is single use viral/bacterial filters that helps to protect your patients and staff. It is >99% effective against viral and bacterial cross-contamination. Why Micro Direct? - Micro Direct’s spirometry experts will help you choose the right spirometer and then FULLY support your staff from training on how to use the spirometer through billing questions; and all Micro Direct spirometers are backed by a 30-day money back guarantee.

Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 1-888-287-8556 sales@mdspiro.com

www.mdspiro.com

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FEATURE 10 | PHYSICIANS OFFICE RESOURCE


FEATURE

Men’s Health: How Small Steps Can Make a Big Impact BY SEKISUI DIAGNOSTICS

While 81% of men can remember the make and model of their first car, barely half of them remember their last trip to the doctor’s office. The average U.S. male lives to 76 – five years short of U.S. female life expectancy at 81 years – and one in five men die before 65. Men are facing a health crisis that is very preventable, but poor health habits, failure to seek medical attention and dangerous occupations lead men to live sicker lives and die sooner. For example, 75% of premature heart disease deaths are men; middle-aged men are twice as likely to have diabetes and each year, more than 230,000 men are diagnosed with prostate cancer and about 30,000 die from it. If those statistics don’t get men’s attention, then heart disease, obesity, tobacco use, stress and high cholesterol can all also lead to erectile dysfunction.

How did we get here?

Unfortunately, men have quite a bit stacked against them that contribute to decreased health, including biological, behavioral and environmental factors. When men are healthier, they live longer and happier lives. So why are we still seeing such alarming numbers? Biological Risk Factors • Metabolism · Cholesterol and diabetes are big health indicators for men • Anatomy/Prostate · Prostate cancer represents about 27% of all cancers in men and is the second deadliest form of cancer • Hormones · Low testosterone can cause a host of negative symptoms Behavioral Risk Factors • Smoking · Smoking contributes to lung cancer, heart disease and emphysema • Alcohol use • Medical care · Men are less likely to schedule their routine doctor’s visits and tend to be more reluctant to approach their doctor with health concerns 2021, ISSUE 6 | 11


• Diet and Exercise

FEATURE

• Accidental injury · Accidents are the #1 cause of death for men under the age of 44 Environmental Risk Factors • Risky Occupations · 92% of workplace deaths are males • Stress

What can men do to take charge of their overall health? Get back to the basics. The good news: 70% of men’s health conditions are preventable and the number of health resources for men is growing. It’s good for men to get back to the basics, and while this list of proactive steps may seem obvious to some, it can help men catch health problems early when treatment is most likely to be successful – or, perhaps, avoid them altogether. 1. Get regular check-ups and screenings In addition to watching their weight and aiming for a more active lifestyle, men should maintain their regular health checkups with their doctor. Checkups and screenings allow men to keep up with their blood pressure, testosterone levels, A1c, waistline and cholesterol levels – all good indicators of your overall health. 2. Eat well, avoid tobacco and limit alcohol use Eating a balanced and nutritious diet can help protect men from numerous health conditions. Tobacco should be avoided completely in their effort to reduce their cancer risk and alcohol should only be used in moderation. 3. Protect the prostate gland A man’s prostate gland grows as he ages, so men should keep an eye on changes in their urinary habits and for urinary problems. 4. Manage stress Get adequate sleep each night – seven to eight hours – and do something enjoyable each day. 5. Protect yourself from unnecessary risks Wearing sunscreen, proper safety equipment and a seat belt can all aid in preventing injury.

There’s a test for that

The Men’s Health Network (Washington, D.C.), a non-profit educational organization of healthcare professionals and individuals focused on improving men’s health and wellness, provides a maintenance schedule (below) for men as a reminder of men needing to take responsibility for their health. Regular checkups and age-appropriate screenings can improve men’s health and reduce their premature death and disability. 12 | PHYSICIANS OFFICE RESOURCE

Sekisui Diagnostics testing solutions

Prostate screening There are certain milestones in men’s health. The first rectal exam between ages 40 and 50 as an initial screening for prostate cancer is a top priority because checking for prostate cancer is important and necessary, just like pulling wisdom teeth and a mammogram. Most prostate cancers are first found during screening with a prostate-specific antigen (PSA) blood test or a digital rectum exam (DRE). Sekisui Diagnostics offers two tests for prostate screening. The FastPack IP Total PSA Immunoassay is a chemiluminescent immunoassay for the in-vitro quantitative determination of PSA in human serum and plasma as anaid in the management of patients with prostate cancer. Also, the FastPack IP Free PSA Immunoassay, not currently available in the United States, is a chemiluminescent immunoassay for the in-vitro quantitative determination of free prostate-specific antigen (free PSA) in human serum. Male menopause Male menopause and another term, andropause, are terms used to describe decreasing levels of the male hormone testosterone that comes with aging. The group of symptoms associated to age-related changes in male hormone levels are also known as testosterone deficiency, androgen deficiency and late-onset hypogonadism. Any man who experiences symptoms should make an appointment with his doctor. Hormone testing In men, about 45-65% of testosterone in blood is normally bound to SHBG (sex hormone-binding globulin) a protein produced mainly in the liver. The remainder either unbound (free testosterone) or weakly and reversibly bound to albumin, which is the main protein in the blood. Risk factors for low SHGB levels include obesity, insulin resistance or type 2 diabetes, hypothyroidism, Cushing syndrome, nonalcoholic fatty liver disease, acromegaly and androgen steroid use. Sekisui Diagnostics offers the FastPack IP Testosterone Immunoassay, a chemiluminescent immunoassay for the in-vitro quantitative determination of total testosterone in human serum and plasma. Pairing this test with FastPack IP SHBG Immunoassay allows a provider to calculate free and bioavailable testosterone levels. SHBG is the newest addition to Sekisui Diagnostics’ FastPack IP System test menu. This fully automated quantitative immunoassay analyzer offers real-time testing with a simple three-step process, enabling physicians to diagnose, monitor and adjust therapy in one patient visit. At Sekisui Diagnostics, we are focused on improving men’s health through the early detection of notable health issues, including high cholesterol, diabetes, prostate cancer, low testosterone and colorectal cancer. Find out more about our diagnostic tests that enable providers to diagnose and treat men at the point-of-care.


Better Patient Experience - Better Patient Retention

Total Testosterone and SHBG In-Office Testing Physicians can better interpret their patients’ androgen status with a comprehensive understanding of the differences between total, free, and bio-available testosterone. Measurement of SHBG in addition to total testosterone enables the calculation of free and bio-available testosterone. The FastPack IP system is a fully automated in-office analyzer that delivers quantitative test results for Testosterone and SHBG in 12 minutes or less with the push of a single button.

9414

For more information call 888-616-0537, Option 2, or visit us at fastpack-poc.com

Testosterone | SHBG | PSA | Vitamin D | TSH | Free T4 | hCG

© 2021 SEKISUI Diagnostics, LLC. All rights reserved. Because every result matters™ is a trademark of SEKISUI Diagnostics, LLC FastPack is a registered trademark of Qualigen Inc.


CRYOSURGERY PRODUCT FOCUS

CRYOLAB® MEDICAL From CryoConcepts CryoLab is a desk-top sized unit that delivers cryogen and employs pre-set spray times to ensure safe and effective treatment. Our lighted wand can spray the cryogen from any direction making it easier to treat all locations on the patient. CryoLab® can dispense nitrous oxide or carbon dioxide allowing physicians to treat cosmetically sensitive areas on the face, hands, and chest with less trauma and downtime. —

9415

View Brochures, Videos & More at POR.io Enter Number 9415 in the Search Area

HISTOFREEZER® FLEX From CryoConcepts This canister-based devices is the latest advance in portable cryosurgery for the physician office. Its advanced design give doctors the option of using cones or buds to deliver the cryogen to the treatment site. There is no risk of cryogen splattering during treatment and our cryogen stays colder versus other products on the market which lead to better first time outcomes.

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View Brochures, Videos & More at POR.io Enter Number 9416 in the Search Area

CRYOMEGA® From CryoConcepts

9417

This pen-like device is the perfect choice when low entry costs, portability, and precise delivery are critical to the practice. CryOmega® dispenses nitrous oxide – the coldest portable cryogen and the pinpoint tip allow physicians to effective treat the lesion site without harming healthy tissue. —

View Brochures, Videos & More at POR.io Enter Number 9417 in the Search Area

14 | PHYSICIANS OFFICE RESOURCE


9418

9419

9420


FLU TESTING PRODUCT FOCUS

CLIA-WAIVED BIOFIRE® FILMARRAY® RESPIRATORY PANEL (RP) EZ 9421

From BioFire The BioFire RP EZ accurately detects and identifies 14 viral and bacterial pathogens—not just Flu A and Flu B—so you can provide your patients with the right treatment, the first time. The test is easy and can be performed right in your office or clinic, with results in about an hour. The BioFire RP EZ is designed to run on a single computer/instrument configuration (EZ Configuration) of the BioFire® FilmArray® 2.0 System.

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View Brochures, Videos & More at POR.io Enter Number 9421 in the Search Area

ACUCY INFLUENZA A&B TEST From Sekisui Diagnostics The Acucy™ Influenza A&B Test is for the rapid, qualitative detection of influenza A and B viral nucleoprotein antigens from both nasal and nasopharyngeal swabs. Utilizing the Acucy™ Reader in either the point-of-care or laboratory setting, workflow flexibility is achieved with both Read Now and Walk Away features. The combination provides clinicians with standardized and definitive result interpretation.

9422

View Brochures, Videos & More at POR.io Enter Number 9422 in the Search Area

OSOM ULTRA PLUS FLU A&B TEST 9423

From Sekisui Diagnostics Stronger Clinical Performance Takes Lateral Flow Testing To The Next Level. Providing superior rapid results at the point-of-care. Fast, easy, cost effective so you can test and treat in one visit. • High Performance- Equivalent or exceeding the performance of reader devices, without the need for an instrument • Results in 10 minutes • OSOM® Custom Care- Exceptional Support/Training by licensed medical technologists and experienced healthcare professionals • Made in the USA —

View Brochures, Videos & More at POR.io Enter Number 9423 in the Search Area 16 | PHYSICIANS OFFICE RESOURCE


YES, WE ALL KNOW THE HASSLE OFTEN ASSOCIATED WITH HA REIMBURSEMENT. FORGET ABOUT IT. WE’RE MAKING HA SIMPLE WITH OUR DIRECT PURCHASE PROGRAM. Introducing a simpler and efficient way to provide your patients osteoarthritis (OA) knee pain relief. With the TriVisc Direct Purchase Program patients can buy Hyaluronic Acid (HA) direct from our pharmacy partner, providing patients with access to significant savings while eliminating the challenges often associated with HA reimbursement. The Result: Your patients may receive OA knee pain relief faster and you avoid the hassle.

Start our DIRECT PURCHASE PROGRAM today.

OrthogenRx, Inc. • Doylestown Commerce Center, 2005 S. Easton Road, Suite 207, Doylestown, PA 18901 • 1-877-517-5445 • Copyright © OrthogenRx 2021. All Rights Reserved. Manufactured by: Tedec-Meiji Farma, S.A. Ctra. M-300, Km 30,500 28802 Alcalá de Henares (Madrid) Spain • COM-TRIV-18-v1


PRODUCT FOCUS

HEMATOLOGY ANALYZERS

9424

MICROS HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL PLUS THE LITEDM From HORIBA Medical Is it viral or bacterial? A CBC with 3-part differential can provide the clues to help distinguish between viral and bacterial infections before you decide to treat. The Micros 60 Hematology analyzer provides a CBC with 3-part Diff result in less than 60 seconds using only 10 µL of sample. Connect to the LiteDM Patient Data Management System for an affordable way to consolidate patient results to one report.

View Brochures, Videos & More at POR.io Enter Number 9424 in the Search Area

TURN SMALL PLACES INTO SMART SPACES From Abbott

9425

With reduced budgets, shrinking laboratory space and staffing challenges, many laboratories need a solution that lets them work smarter with less. The CELL-DYN Emerald 22 AL is a full performance, automated optical 5-part differential analyzer that delivers smarter results for small to midsize clinical laboratories. • Compact Design • Walkaway Functionality • Ease Of Use • Smart Safety Features

View Brochures, Videos & More at POR.io Enter Number 9425 in the Search Area

CELL-DYN EMERALD HEMATOLOGY ANALYZER From Abbott

9426

CELL-DYN Emerald is a 3-part differential hematology analyzer that offers high performance in an affordable, compact design that provides reliable and accurate patient results every time. As a smaller operating laboratory, you need a solution that offers reliable results. CELL-DYN Emerald provides results in under 65 seconds. CELL-DYN Emereald’s small size, simple touch screen software and reliability offer an easy-to-use, truly compact table/bench top instrument for easy performance in your laboratory.

View Brochures, Videos & More at POR.io Enter Number 9426 in the Search Area 18 | PHYSICIANS OFFICE RESOURCE


GET BETTER OUTCOMES WITH CRYOSURGERY

NEW FOR

2021!

Your choice of a cryosurgical device has a big impact on patient outcomes. CryoConcepts has the broadest line of cryosurgical equipment in the world and our 28 years of experience is built into every single product.

9428 9427

BETTER DESIGN. BETTER OUTCOMES. BETTER FOR THE ENVIRONMENT. Our world class products include: CryOmega®, a portable pen-like device, CryoLab® Medical, a desktop-sized cryo unit, and Histofreezer® FLEX, our next generation canister that uses both cones and buds AND has the first returnable canister that is better for the environment.

CONTACT US TODAY !!

MAR-115 (Rev 1)

Scan QR code for: ❆ A Virtual or In-Office Demo of any of our products

All Things

CRYO

❆ A FREE Lunch & Learn with our nationwide team of Cryo Experts

www.CryoConcepts.com

❆ A FREE E-book on better outcomes using cryosurgery in your practice


PRODUCT FOCUS

IMMUNOASSAY ANALYZERS FULLY AUTOMATED QUANTITIVE IMMUNOASSAY ANALYZER

9429

From Sekisui Diagnostics The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory. Utilizing sophisticated chemiluminescence technology, the FastPack® IP System provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button. Menu includes Vitamin D, Testosterone, TSH, Free T4 PSA and hCG.

View Brochures, Videos & More at POR.io Enter Number 9429 in the Search Area

THE NANOENTEK FREND IMMUNOASSAY SYSTEM From NanoEnTek The NanoEnTek FREND Immunoassay System provides Vitamin D, TSH, fT4, PSA, and Testosterone results in minutes with a no cost placement program. Complete all 5 tests in less than 20 minutes for same visit patient consultation. PSA and TSH results are available in 3 minutes or less. Imagine having a new source of revenue with improved practice efficiency and patient satisfaction. Thoughtfully designed, with your practice in mind.

9430

View Brochures, Videos & More at POR.io Enter Number 9430 in the Search Area

LABORATORY SERVICES MEDICUS LIS 9431

From Medicus LIS If you are considering in-house lab testing, including Covid-19 testing and required reporting to state agencies, connecting Lab to LIS and EHR makes the process of test orders to completed results much easier. Providers receive test results posted to patient charts in real-time, expediting patient care, saving time, money and even preparing for lab test reimbursement goals. Link Your Lab with Medicus LIS today! Contact us: 888-643-8081 sales@medicuslis.com —

View Brochures, Videos & More at POR.io Enter Number 9431 in the Search Area

20 | PHYSICIANS OFFICE RESOURCE


The Adview 2 is still the only truly modular diagnostic station that grows with your needs. Start with blood pressure and choose temperature or pulse oximetry option at the time of purchase.

Bionet CardioCare 2000: $1,255.00 Schiller AT-2 Plus: $2,626.00* 9433 *add Spirometry: $649.00 Burdick ELI 280: $4,088.00 Welch Allyn CP150 w/ Interp: $3,465.00

9432

9435

9434

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Coaxial Ophth, Fiber Optic Oto, Speucla Dispenser, Aneroid BP, Wall Transformer and Wall Board without Thermometer: $979.00 with Thermometer: $1,416.00

9440

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SPIROMETRY PRODUCT FOCUS

PORTABLE, SINGLE CLICK OPERATION SPIROMETER 9443

From MicroDirect The MicroDirect SpiroUSB many features include single click operation of all main functions, full ATS/ERS test quality checks, real time Flow/Volume and Volume/ Time traces, a choice of child incentive displays, choice of predicted values, estimated lung age, pre/post bronchodilator comparisons and can be used on multiple PC’s with dongle software protection key. The child incentive display and ATS quality checks ensure maximal results every time. Use with a laptop for true portability.

View Brochures, Videos & More at POR.io Enter Number 9443 in the Search Area

MICRO 1 SPIROMETER From MicroDirect Specifically designed for situations where low cost precision spirometry measurements are required, the Micro I Spirometer measures the following parameters FEV1, FVC, PEF, FEF25-75, EEV6, FEV1/FVC, FEV1/FEV6, FEF25 and FEF25 that cn be displayed along with percent predicted and post bronchodilator comparisons and provide an optional printout if needed. Extremely lightweight and portable making it suitable for hospital outreach clinics, bedside screenings, health fair screenings and other situations where remote testing is required.

9444

View Brochures, Videos & More at POR.io Enter Number 9444 in the Search Area

SPIROMETRY IS EASY From MicroDirect Unless the equipment is easy to use, it will not be fully utilized by your staff. The MicroLab and MicroLoop are menu driven via a large graphic display and the test takes less than five minutes to perform. The easy-to-read reports, quality checks and built-in interpretation assist with your diagnosis. Your office sees patients with indications for spirometry on a daily basis. Accurately and quickly diagnosis them so you can properly treat them.

9445

22 | PHYSICIANS OFFICE RESOURCE

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LAB-ACCURATE RESULTS FOR ACR AND HBA1C From Abbott With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.

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24 | PHYSICIANS OFFICE RESOURCE

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FAST AND EASY. ACCURATE RESULTS EVERY TIME. CELL-DYN EMERALD Compact, easy-to-use 3-part differential hematology analyzer provides you with proven methods and technology, including electronic impedance, absorption spectrophotometry, electronic valves, cyanide-free lyse reagent, LCD color touch screen and USB ports. C O M PAC T D E S I G N Conserving valuable laboratory workspace with a small footprint and only 2 reagents plus on-board cleaner.

EASE OF USE • Decreasing manual entry errors and increasing compliance by use of barcoded reagents • Reducing hands-on time with touch-free scheduled daily maintenance, startup and shutdown

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RELIABILIT Y Helping you keep your commitments

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COREL ABORATORY.ABBOT T/HEMATOLOGY ©2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.

For in vitro diagnostic only. Refer to the Operator’s Manual for operational precautions, limitations, and hazards. ADD-00074091 12/20.


ASSESSING AND MONITORING COVID-19 PATIENTS. Urgent care facilities, primary care practices, and other outpatient settings at the front lines of the COVID-19 pandemic need on-site testing solutions to support patient assessment and monitoring. With-patient testing can lead to better healthcare performance by facilitating decisions that can optimize patient outcomes in real time, improving the quality of patient care.

9452

For facilities treating COVID-19 patients, having rapid, accurate diagnostic test results may be useful when assessing or monitoring patients for: • C-Reactive Protein (CRP) Levels may be elevated in COVID-19 cases, especially severe cases.2-15 • Liver, Kidney and Cardiac function Elevated levels of the following biomarkers may be indicators of COVID-19 severity:16-27 - Alanine Aminotransferase (ALT)16,17,20-27 - Albumin (ALB)16,19-22,25-27 - Aspartate Aminotransferase (AST)16,17,19-21,23-26 - Creatine Kinase (CK)16,18,20,22-24 - Creatinine (CREAT)16,22,23,25,27 - Total Bilirubin (TBILI)16,20,25,27

ON-SITE TESTING MADE EASY: PICCOLO XPRESS.® The Piccolo Xpress portable diagnostic analyzer offers a full complement of blood chemistry tests, including CLIA-waived tests. Get accurate results in minutes, at the point-of-care. SEE A LIST OF KEY PICCOLO XPRESS PANELS ON BACK.

For in vitro diagnostic use only. The Piccolo Xpress does not directly diagnose COVID-19.


KEY PICCOLO XPRESS PANELS. CLIA-WAIVED PANELS

MODERATELY COMPLEX PANELS

Comprehensive Metabolic Panel

BioChemistry Panel Plus

Na+, K+, CI-, tCO2, Ca, BUN, Crea, Glu,

ALB, ALP, ALT, AMY, AST, BUN, Ca,

ALB, ALP, ALT, AST, TP, tBIL, eGFR*

Crea, Glu, GGT, TP, UA, CRP, eGFR*

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ALB, ALP, ALT, AMY, AST, GGT,

ALB, ALP, ALT, AST, tBIL, dBIL, TP

tBIL, TP

*Calculated

To learn how the Piccolo Xpress portable diagnostic analyzer can help transform your patient care, contact your Abbott Point of Care Representative or visit www.pointofcare.abbott 1.

2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.

The Governing Board The American Association for the Study of Liver Diseases, Released: April 7, 2020. CLINICAL INSIGHTS FOR HEPATOLOGY AND LIVER TRANSPLANT PROVIDERS DURING THE COVID-19 PANDEMIC. Guan WJ et al. medRxiv preprint 2020; doi: https://doi.org/10. 1101/2020.02.06.20020974 Chen N et al. Lancet 2020; 395: 507–13 ; https://doi. org/10.1016/S0140-6736(20)30211-7 Cao W et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.02.23.20026963 Shi H et al. Lancet Infect Dis 2020 ; https://doi.org/10.1016/ S1473-3099(20)30086-4 Shi S et al. Jama Cardiology 2020; published online March 25; doi:10.1001/jamacardio.2020.0950 Xu H et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.03.05.20031591 Young BE et al. JAMA. Published online March 3, 2020; doi:10.1001/jama.2020.3204 Ruan Q et al. Intensive Care Medicine 2020. https://doi. org/10.1007/s00134-020-05991-x Zhou B. Research Square 2020; DOI:10.21203/rs.3.rs-18079/v1 Zhou S et al. AJR 2020; 215:1-8; doi.org/10.2214/AJR.20.22975 Li J et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.02.11.20022053 Deng SQ, Peng HJ. J. Clin. Med. 2020; 9, 575 (Review); doi:10.3390/jcm9020575 Ständiger Arbeitskreis der Kompetenz- und Behandlungszentren für Krankheiten durch hochpathogene Erreger am Robert Koch-Institut (STAKOB). Hinweise zu Erkennung, Diagnostik

15.

16.

17. 18.

19.

20.

21.

und Therapie von Patienten mit COVID-19; Downloaded 13. March 2020; www.rki.de/covid-19-therapie Chinese CoVID Management Guidelines-19, Version 7; published on 3/3/2020 by R.P.C. National Health Commission and the National Administration of Traditional Medicine of R.P.C.; translated by Jinwei Sun, Physician Specializing in Cardiovascular Disorders at the University of Milan-Bicocca Henry et al. 2020 Apr 10 Clinical Chemistry and Laboratory Medicine. Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 PMID: 32286245 DOI: 10.1515/cclm2020-0369. Ferrari et al. 2020 Apr 16 Clinical Chemistry and Laboratory Medicine. Routine blood tests as a potential diagnostic tool for COVID-19 PMID: 3230176 DOI: 10.1515/cclm-2020-0398. Yuan et al. 2020 Mar 29 Inflammation Research. The correlation between viral clearance and biochemical outcomes of 94 COVID-19 infected discharged patients PMID: 32227274 DOI: 10.1007/s00011-020-013242-0. Huang et al. 2020 Feb 15 The Lancet. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China PMID: 31986264 PMCID: PMC7159299 DOI: 10.1016/ S0140-6736(20) 30183-5. Chen et al. 2020 Feb 15 The Lancet. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study PMID: 32007143 PMCID: PMC7135076 DOI: 10.1016/S0140-6736(20)30211-7. The Governing Board The American Association for the Study of Liver Diseases, Released: April 7, 2020. CLINICAL IN

POINT OF CARE ©Abbott Point of Care Inc. 400 College Road East, Princeton, NJ 08540 (609) 454-9000 (609) 419-9370 (fax) www.pointofcare.abbott For in vitro diagnostic use only.

I

This material is intended for a U.S. audience only.

COVID-19 Channel Brochure - US 2994Rev.1 09/20 Piccolo Xpress is a registered trademark of Abaxis, Inc. and distributed by Abbott Point of Care. Abaxis 888-3354 Rev A

22.

23.

24.

25.

26.

27.

SIGHTS FOR HEPATOLOGY AND LIVER TRANSPLANT PROVIDERS DURING THE COVID-19 PANDEMIC. Zhou et al. 2020 Mar 28 The Lancet. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study PMID 32171076 DOI: 10.1016/S0140-6736(20) 30566-3. Guan et al. 2020 Apr 30 The New England Journal of Medicine. The Clinical Characteristics of Coronavirus Disease 2019 in China PMID: 32109013 PMCID: PMC7092819 DOI: 10.1056/NEJMoa2002032. Holshue et al and The Washington State 2019-nCoV Case Investigation Team 2020 Mar 5 The New England Journal of Medicine Case Reports. First Case of 2019 Novel Coronavirus in the United States PMID: 32004427 PMCID: PMC7092802 DOI: 10.1056/NEJMoa2001191. Wu et al. 2020 Mar 13 JAMA Internal Medicine. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China PMID: 32167524 PMCID: PMC7070509 DOI: 10.1001/jamainternmed.2020.0994. Chen et al. 2020 May 1 The Journal of Clinical Investigation. Clinical and immunological features of severe and moderate coronavirus disease 2019 PMID: 32217835 PMCID: PMC7190990 (available on 2020-08-01) DOI: 10.1172/ JCI137244. Wang et al. 2020 Apr 23 The Journal of Clinical Investigation Insight. The laboratory tests and host immunity of COVID-19 patients with different severity of illness PMID: 32324595 DOI: 10.1172/jci.insight.137799.


FEATURE 28 | PHYSICIANS OFFICE RESOURCE


5 MUST-HAVES FOR GREAT PHYSICIAN ONLINE PROFILES BY BRIAN R DOOLEY

Patients have a lot of choices when it comes to physicians. Making sure your online profile is up to date, complete, and contains these five items will improve the chances that a website visitor will become a patient.

2021, ISSUE 6 | 29


FEATURE

Having good rapport with patients is important, and that process starts before patients ever walk in the door.

Create a personal connection. Having good rapport with patients is important, and that process starts before patients ever walk in the door. How often have you seen a physician bio that only contains a single, humanizing detail in the last sentence: “Dr. John lives in Washington, DC with his wife, Karen.” Some physicians may be hesitant to provide personal info, that shouldn’t stop you from sounding personable in your profile. To create a stronger chance of a connection, providers should consider adding interests and activities outside of work: “When he’s not at work, Dr. John enjoys cheering on the Chicago Cubs,” with a small photograph of him and his family at the ballpark. Another consideration to sound more personable is to include quotes and conversational language in your profile. Instead of saying, “Dr. John specializes in kidney stones,” include a quote that says, “I treat a lot of patients with kidney stones. They can be really painful, but we have several treatments available that can provide relief in a matter of hours. One of the best parts of my job is seeing the look of relief on a patient’s face when their pain has disappeared.”

has advanced knowledge or expertise that can help them. If you’re just getting started and have a preference for certain disease states, include that in your profile. It will help steer the patients you want into your practice. Awards and recognition. Honors like, “Doctor of the Year,” and “Best Plastic Surgeon — Chicago Tribune,” are beneficial to include in your online profile. Having “MD” or “DO” behind your name builds authority, and adding awards and recognition will build even more. Location and contact information. Most providers will have a separate contact page, but in addition to that, each provider profile should have their location and contact numbers. Especially if they practice at more than one location. This makes the patient experience more seamless. A provider’s profile page will likely be the first Google result for their name, and contacting that physician for an appointment or question are among the most common reasons patients visit a medical provider’s website.

Professional Photo.

Call to action.

For under $200, you can find a local photographer that can take a professional headshot for your profile. This picture will be viewed thousands of times and may last several years, so it’s worth the minimal investment up front to make sure it’s nice. Patients often make judgments, fairly or not, about the quality of medicine based on appearances. Make sure your appearance is top notch.

For most providers, the logical next step is to request an appointment with the provider. To make this easier on the patient, the call-to-action should be very clear. It might be an appointment line phone number immediately after the bio, a “Book Now” button that takes you to an online form and contact info, etc. It should be immediately obvious to the patient what they should do next.

It may seem trivial, but make sure you’re smiling in your photo. Much research has been done on the power of a smile to increase trust, which is imperative in the doctor/patient relationship.

Implementing these points in your physician profile will put you in the top tier of providers who have taken the time to improve the message they are sending to prospective patients.

Special training, specialties, areas of interest. If you have special training or expertise in an area, be sure to include it in your bio. Patients prefer to see someone who

30 | PHYSICIANS OFFICE RESOURCE

Brian Dooley is an expert in Digital Marketing, Reputation Management, and the Founder of Independence Digital – a marketing firm for medical practices.


Solid & Glass Door Refrigerators From 1 to 15 Cu.ft.

Refrigerators & Freezers From 23 to 49 Cu.ft. Refrigeration designed and purpose-built for pharmacy, medication, and vaccination applications to support meeting CDC/VFC vaccine storage guidelines

+/-1ºC variation derived from the maximum deviation of an NTC sensor in a 1 oz. vial located nearest the champer geometric center during a 24 hour test period

9453

Advanced Temperature Control & Durable Performance

• Intelligent microprocessor digital temperature controller • Adjustable operating control range from +2 to +8ºC • Digital display of the min/max temperature in Celsius or Fahrenheit • Password protected control parameters beyond setpoitn • Optimized forced air cooling for excellent stability & uniformity with rapid recovery • Open door and high/low temperature alarms • Factory installed lock conveniently located towards the top of each unit • $GMXVWDEOH VKHOYLQJ FDQ EH VSDFHG LQ óµ LQWHUYDOV IRU IOH[LEOH VWRUDJH

Pharma-Vac Refrigerators Accucold ARS1PV ARG1PV ARS3PV ARG3PV ARS6PV ARG6PV ARS8PV ARG8PV ARS12PV ARG12PV ARS15PV ARG15PV

Capacity 1 cu.ft. 1 cu.ft. 3 cu.ft. 3 cu.ft. 6 cu.ft. 6 cu.ft. 8 cu.ft. 8 cu.ft. 12 cu.ft. 12 cu.ft. 15 cu.ft. 15 cu.ft.

Height 21.5” 21.5” 33.75” 33.75” 32.5” 32.5” 50” 50” 61.75” 61.75” 72” 72”

Width 17.5” 17.5” 18.5” 18.5” 23.5” 23.5” 23.38” 23.38” 23.38” 23.38” 23.5” 23.5”

Depth 19.5” 20” 19” 19.5” 24.5” 25” 24.5” 25” 24.5” 25” 24.5” 25”

Door White Glass White Glass White Glass White Glass White Glass White Glass

790*, 865.00 878.00 965.00 969.00 1,060.00 1,072.00 1,284.00 1,349.00 1,788.00 1,801.00 1,970.00 1,983.00

Height 83.75 83.75 83.75 83.75

Width 27.5 27.5 55.25 55.25

Depth 31 31 31 31

Door (1) Stainless (1) Glass (2) Stainless (2) Glass

790*, 2,466.00 2,811.00 3 634 00 4,186.00

Height 83.75 83.75

Width 27.5 55.25

Depth 31 31

Door (1) Stainless (2) Stainless

790*, 2,804.00 4,299.00

Pharma-Lab Refrigerators Accucold ARS23ML ARG23ML ARS49ML ARG49ML

Capacity 23 cu.ft. 23 cu.ft. 49 cu.ft. 49 cu.ft.

Pharma-Lab Freezers Accucold AFS23ML AFS49ML

Capacity 23 cu.ft. 49 cu.ft.

Choosing the Right Sized Unit Below are a few handy steps for determining the ideal Accucold refrigerator size for your clinic:

1

Estimate the maximum number of doses of publicly-provided vaccine and privately purchased vaccine that will be in your refrigerator.

Refrigerator: Public Vaccine

Add the number of doses on hand (current inventory) from your last order form. ________________

2

Match your maximum doses with the minimum cubic feet needed to safely store your vaccine

Max. Doses

Minimum Cubic Ft.

2,000+ doses

may need more than one refrigerator

1000-2000

40 cu.ft 36 cu.ft 21-23 cu.ft

Private Vaccine

+ ________________

900-1000 801-900

Total doses

= ________________

701-800

17-19.5 cu.ft

Multiply (max inventory) Maximum doses

x 1.25 = ________________

400-700

11-16.7 cu.ft

100-399

4.9-6.1 cu.ft


In adults with polycythemia vera (PV) who have had an inadequate response to hydroxyurea (HU)1

INTERVENE JAKAFI® with

TO ACHIEVE DURABLE COUNT CONTROL In the phase 3 RESPONSE* trial,

Jakafi demonstrated superior results† vs BAT1‡ Composite primary endpoint

23%

VS

(25/110) of patients receiving Jakafi achieved Hct control and ≥35% spleen volume reduction at week 32

<1% §

Probability of Maintaining the Primary Response at 5 Years 2 (95% CI, 0.51-0.88)

Probability, %

80 60 40

+ Censoring times – Jakafi

No. of responders/events/censor: 25/6/19

0 0

12

24

36

48

60

72

84

96

108

120

132

144

156

168

180

192

204

Jakafi 95% CI, 0.15-0.32; BAT 95% CI, 0.00-0.05.1

Kaplan-Meier analysis was conducted in week 32 primary responders, beginning at week 322

100

20

(1/112) of patients receiving BAT (P < 0.0001)1§

216

228

Duration of Response, wk No. at risk 25 25 25 25 25 25 24 22 22 22 22 22 22 22 21 21 21 20 20 20 20 19 19 19 18 18 18 17 17 17 17 17 16 16 16 11 11 9 0 Events 0 0 0 0 0 0 1 2 2 2 2 2 2 2 3 3 3 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 6 6 6 6 6 6 6

Progression was defined as: the first of 2 consecutive Hct assessments that confirmed phlebotomy eligibility, a spleen volume assessment that was reduced by <35% from the baseline AND that was ≥25% increased at the time of the best-documented spleen volume response, death, or development of MF or acute leukemia3 The median duration of primary response was not reached. Reprinted from Lancet Haematology. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. 2020;7(3):e226-e237, with permission from Elsevier.

BAT, best available therapy; CI, confidence interval; Hct, hematocrit; MF, myelofibrosis. * The RESPONSE (Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care) trial was a randomized, open-label, active-controlled phase 3 trial comparing Jakafi with BAT in 222 patients with PV. Patients enrolled in the study had been diagnosed with PV for at least 24 weeks, had an inadequate response to or were intolerant of HU, required phlebotomy for Hct control, and exhibited splenomegaly. All patients were required to demonstrate Hct control between 40% and 45% prior to randomization. After week 32, patients were able to cross over to Jakafi treatment.1,4 † The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by CT or MRI. To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value).1,4 ‡ BAT included HU (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%).1

Indications and Usage Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.

Important Safety Information Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi Severe neutropenia (ANC <0.5 × 109/L) was generally reversible by withholding Jakafi until recovery Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines

Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation of Jakafi during treatment of active TB should be based on the overall risk-benefit determination Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate Advise patients about early signs and symptoms of herpes zoster and to seek early treatment Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections. Monitor and treat patients with chronic HBV infection according to clinical guidelines When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi-organ failure. If any of these


In the phase 3 RESPONSE* trial,

More patients achieved Hct control with Jakafi in the absence of phlebotomy eligibility1 Individual component of the primary endpoint

60%

VS

(66/110) of patients receiving Jakafi achieved Hct control at week 32

19%

(21/112) of patients receiving BAT 1

To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as hematocrit >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value)1,4

Probability of Maintaining Hct Control a at 5 Years 2

Kaplan-Meier analysis was conducted in week 32 Hct control responders, beginning at week 322

Absence of phlebotomy eligibility

a

(95% CI, 0.60-0.83)

Progression events for the evaluation of duration of absence of phlebotomy eligibility included first of 2 consecutive Hct assessments that confirms phlebotomy eligibility, death, or development of MF or acute leukemia3

100

Probability, %

80 60 40 20

+ Censoring times – Jakafi

0

No. of responders/events/censor: 66/16/50 0

12

24

36

48

60

72

84

96

108

120

132

144

156

168

180

192

204

216

228

240

252

264

Duration of Response, wk No. at risk 66 66 66 66 66 66 64 63 62 60 58 58 56 56 56 56 56 55 54 54 53 51 49 49 48 48 48 44 44 44 42 42 42 41 40 39 39 39 39 38 28 5 3 1 0 Events 0 0 0 0 0 0 0 1 2 4 5 5 6 6 6 6 6 7 8 8 9 10 10 10 10 10 10 12 12 12 14 14 14 15 15 16 16 16 16 16 16 16 16 16 16

Reprinted from Lancet Haematology. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. 2020;7(3):e226-e237, with permission from Elsevier.

For more data on long-term results with Jakafi, visit JakafiResults.com. hepatic impairment. Patients should be closely monitored and the occur after discontinuation or while tapering Jakafi, evaluate and dose titrated based on safety and efficacy treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi Use of Jakafi during pregnancy is not recommended and should only without consulting their physician. When discontinuing or interrupting be used if the potential benefit justifies the potential risk to the fetus. Jakafi for reasons other than thrombocytopenia or neutropenia, Women taking Jakafi should not breastfeed during treatment and for consider gradual tapering rather than abrupt discontinuation 2 weeks after the final dose Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations Please see Brief Summary of Full Prescribing Information for Jakafi on the following pages. Treatment with Jakafi has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess To learn more about Jakafi, visit HCP.Jakafi.com. lipid parameters 8-12 weeks after initiating Jakafi. Monitor and treat References: 1. Jakafi [package insert]. Wilmington, DE: lncyte Corporation. 2. Kiladjian J-J, according to clinical guidelines for the management of hyperlipidemia Zachee P, Hino M, et al. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. Lancet Haematol. In myelofibrosis and polycythemia vera, the most common 2020;7(3):e226-e237. 3. Data on File. Incyte Corporation. Wilmington, DE. 4. Vannucchi AM, nonhematologic adverse reactions (incidence ≥15%) were bruising, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of dizziness, headache, and diarrhea. In acute graft-versus-host polycythemia vera. N Engl J Med. 2015;372(5):426-435. disease, the most common nonhematologic adverse reactions (incidence >50%) were infections and edema Dose modifications may be required when administering Jakafi with Jakafi and the Jakafi logo are registered trademarks of Incyte. strong CYP3A4 inhibitors or fluconazole or in patients with renal or © 2020, Incyte Corporation. MAT-JAK-02405 08/20


BRIEF SUMMARY: For Full Prescribing Information, see package insert. INDICATIONS AND USAGE Myelofibrosis Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults. Polycythemia Vera Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea. Acute GraftVersus-Host Disease Jakafi is indicated for treatment of steroidrefractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia. [see Dosage and Administration (2.1) in Full Prescribing Information]. Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [see Dosage and Administration (2), and Adverse Reactions (6.1) in Full Prescribing Information]. Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi. Severe neutropenia (ANC less than 0.5 × 109/L) was generally reversible by withholding Jakafi until recovery [see Adverse Reactions (6.1) in Full Prescribing Information]. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [see Dosage and Administration (2), and Adverse Reactions (6.1) in Full Prescribing Information]. Risk of Infection Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting therapy with Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines. Tuberculosis Tuberculosis infection has been reported in patients receiving Jakafi. Observe patients receiving Jakafi for signs and symptoms of active tuberculosis and manage promptly. Prior to initiating Jakafi, patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Risk factors include, but are not limited to, prior residence in or travel to countries with a high prevalence of tuberculosis, close contact with a person with active tuberculosis, and a history of active or latent tuberculosis where an adequate course of treatment cannot be confirmed. For patients with evidence of active or latent tuberculosis, consult a physician with expertise in the treatment of tuberculosis before starting Jakafi. The decision to continue Jakafi during treatment of active tuberculosis should be based on the overall risk-benefit determination. Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate. Herpes Zoster Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected [see Adverse Reactions (6.1) in Full Prescribing Information]. Hepatitis B Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Jakafi. The effect of Jakafi on viral replication in patients with chronic HBV infection is unknown. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines. Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi Following discontinuation of Jakafi, symptoms from myeloproliferative neoplasms may return to pretreatment levels over a period of approximately one week. Some patients with MF have experienced one or more of the following adverse events after discontinuing Jakafi: fever, respiratory distress, hypotension, DIC, or multi-organ failure. If one or more of these occur after discontinuation of, or while tapering the dose of Jakafi, evaluate for and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi therapy without consulting their physician. When discontinuing or interrupting therapy with Jakafi for reasons other than thrombocytopenia or neutropenia [see Dosage and Administration (2.6) in Full Prescribing Information], consider tapering the dose of Jakafi gradually rather than discontinuing abruptly. Non-Melanoma Skin Cancer Non-melanoma skin cancers including basal cell, squamous cell, and Merkel cell

carcinoma have occurred in patients treated with Jakafi. Perform periodic skin examinations. Lipid Elevations Treatment with Jakafi has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined in patients treated with Jakafi. Assess lipid parameters approximately 8-12 weeks following initiation of Jakafi therapy. Monitor and treat according to clinical guidelines for the management of hyperlipidemia. ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Thrombocytopenia, Anemia and Neutropenia [see Warnings and Precautions (5.1) in Full Prescribing Information] • Risk of Infection [see Warnings and Precautions (5.2) in Full Prescribing Information] • Symptom Exacerbation Following Interruption or Discontinuation of Treatment with Jakafi [see Warnings and Precautions (5.3) in Full Prescribing Information] • Non-Melanoma Skin Cancer [see Warnings and Precautions (5.4) in Full Prescribing Information]. Clinical Trials Experience in Myelofibrosis Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with MF in two Phase 3 studies. In these two Phase 3 studies, patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 89% of patients treated for more than 6 months and 25% treated for more than 12 months. One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In patients starting treatment with 15 mg twice daily (pretreatment platelet counts of 100 to 200 × 109/L) and 20 mg twice daily (pretreatment platelet counts greater than 200 × 109/L), 65% and 25% of patients, respectively, required a dose reduction below the starting dose within the first 8 weeks of therapy. In a double-blind, randomized, placebo-controlled study of Jakafi, among the 155 patients treated with Jakafi, the most frequent adverse reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, anemia and neutropenia are dose-related effects. The three most frequent nonhematologic adverse reactions were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of causality, was observed in 11% of patients treated with Jakafi and 11% of patients treated with placebo. Table 1 presents the most common nonhematologic adverse reactions occurring in patients who received Jakafi in the double-blind, placebo-controlled study during randomized treatment. Table 1: Myelofibrosis: Nonhematologic Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled Study During Randomized Treatment Jakafi (N=155) All Gradesa Adverse (%) Reactions 23 Bruisingb Dizzinessc 18 Headache 15 Urinary Tract 9 Infectionsd 7 Weight Gaine Flatulence 5 Herpes 2 Zosterf

Placebo (N=151)

Grade Grade All Grade Grade 3 4 Grades 3 4 (%) (%) (%) (%) (%) <1 <1 0

0 0 0

15 7 5

0 0 0

0 0 0

0

0

5

<1

<1

<1 0

0 0

1 <1

<1 0

0 0

0

0

<1

0

0

National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified, nitrite urine present e includes weight increased, abnormal weight gain f includes herpes zoster and post-herpetic neuralgia a

b

Description of Selected Adverse Reactions: Anemia In the two Phase 3 clinical studies, median time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (<1%) discontinued treatment because of anemia. In patients receiving

Jakafi, mean decreases in hemoglobin reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern was observed in patients regardless of whether they had received transfusions during therapy. In the randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo treated patients.Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts above 50 × 109/L was 14 days. Platelet transfusions were administered to 5% of patients receiving Jakafi and to 4% of patients receiving control regimens. Discontinuation of treatment because of thrombocytopenia occurred in <1% of patients receiving Jakafi and <1% of patients receiving control regimens. Patients with a platelet count of 100 × 109/L to 200 × 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 × 109/L (17% versus 7%). Neutropenia In the two Phase 3 clinical studies, 1% of patients reduced or stopped Jakafi because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study. Table 2: Myelofibrosis: Worst Hematology Laboratory Abnormalities in the Placebo-Controlled Studya

Laboratory Parameter Thrombocytopenia Anemia Neutropenia a b

Jakafi Placebo (N=155) (N=151) All Grade Grade All Grade Grade Gradesb 3 4 Grades 3 4 (%) (%) (%) (%) (%) (%) 70 96 19

9 34 5

4 11 2

31 87 4

1 16 <1

0 3 1

Presented values are worst Grade values regardless of baseline National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0

Additional Data from the Placebo-Controlled Study • 25% of patients treated with Jakafi and 7% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transaminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 2% for Jakafi with 1% Grade 3 and no Grade 4 ALT elevations. • 17% of patients treated with Jakafi and 6% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase (AST). The incidence of Grade 2 AST elevations was <1% for Jakafi with no Grade 3 or 4 AST elevations. • 17% of patients treated with Jakafi and <1% of patients treated with placebo developed newly occurring or worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was <1% for Jakafi with no Grade 3 or 4 cholesterol elevations. Clinical Trial Experience in Polycythemia Vera In a randomized, open-label, active-controlled study, 110 patients with PV resistant to or intolerant of hydroxyurea received Jakafi and 111 patients received best available therapy [see Clinical Studies (14.2) in Full Prescribing Information]. The most frequent adverse reaction was anemia. Discontinuation for adverse events, regardless of causality, was observed in 4% of patients treated with Jakafi. Table 3 presents the most frequent nonhematologic adverse reactions occurring up to Week 32. Table 3: Polycythemia Vera: Nonhematologic Adverse Reactions Occurring in ≥ 5% of Patients on Jakafi in the Open-Label, Active-controlled Study up to Week 32 of Randomized Treatment Jakafi (N=110)

Adverse Reactions Diarrhea Dizzinessb Dyspneac Muscle Spasms Constipation Herpes Zosterd

All Gradesa (%) 15 15 13 12 8 6

Table 3 continued above.

Grade 3-4 (%) 0 0 3 <1 0 <1

Best Available Therapy (N=111) All Grades (%) 7 13 4 5 3 0

Grade 3-4 (%) <1 0 0 0 0 0


Table 3 continued.

Jakafi (N=110) All Gradesa (%) Adverse Reactions Nausea 6 Weight Gaine 6 Urinary Tract Infectionsf 6 Hypertension 5

Best Available Therapy (N=111)

Grade 3-4 (%) 0 0 0 <1

All Grades (%) 4 <1 3 3

Grade 3-4 (%) 0 0 0 <1

National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 includes dizziness and vertigo c includes dyspnea and dyspnea exertional d includes herpes zoster and post-herpetic neuralgia e includes weight increased and abnormal weight gain f includes urinary tract infection and cystitis

Table 6: Acute Graft-Versus-Host Disease: Selected Laboratory Abnormalities Worsening from Baseline in the Open-Label, Single Cohort Study Jakafi (N=71) Worst grade during treatment Laboratory Parameter All Gradesa (%) Grade 3-4 (%) Hematology Anemia 75 45 Thrombocytopenia 75 61 Neutropenia 58 40 Chemistry Elevated ALT 48 8 Elevated AST 48 6 Hypertriglyceridemia 11 1

a

b

Clinically relevant laboratory abnormalities are shown in Table 4. Table 4: Polycythemia Vera: Selected Laboratory Abnormalities in the Open-Label, Active-controlled Study up to Week 32 of Randomized Treatmenta Jakafi (N=110) All Grade Laboratory Gradesb 3 Parameter (%) (%) Hematology Anemia 72 <1 Thrombocytopenia 27 5 Neutropenia 3 0 Chemistry Hypercholesterolemia 35 0 Elevated ALT 25 <1 Elevated AST 23 0 Hypertriglyceridemia 15 0 a b

Best Available Therapy (N=111) Grade All Grade Grade 4 4 Grades 3 (%) (%) (%) (%) <1 <1 <1

58 24 10

0 3 <1

0 <1 0

0 0 0 0

8 16 23 13

0 0 <1 0

0 0 0 0

Presented values are worst Grade values regardless of baseline National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0

Clinical Trial Experience in Acute Graft-Versus-Host Disease In a single-arm, open-label study, 71 adults (ages 18-73 years) were treated with Jakafi for acute GVHD failing treatment with steroids with or without other immunosuppressive drugs [see Clinical Studies (14.3) in Full Prescribing Information]. The median duration of treatment with Jakafi was 46 days (range, 4-382 days). There were no fatal adverse reactions to Jakafi. An adverse reaction resulting in treatment discontinuation occurred in 31% of patients. The most common adverse reaction leading to treatment discontinuation was infection (10%). Table 5 shows the adverse reactions other than laboratory abnormalities. Table 5: Acute Graft-Versus-Host Disease: Nonhematologic Adverse Reactions Occurring in ≥ 15% of Patients in the Open-Label, Single-Cohort Study Adverse Reactionsa Infections Edema Hemorrhage Fatigue Bacterial infections Dyspnea Viral infections Thrombosis Diarrhea Rash Headache Hypertension Dizziness a b

Jakafi (N=71) All Gradesb (%) Grade 3-4 (%) 55 41 51 13 49 20 37 14 32 28 32 7 31 14 25 11 24 7 23 3 21 4 20 13 16 0

Selected laboratory abnormalities are listed in Table 6 below National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03

Selected laboratory abnormalities during treatment with Jakafi are shown in Table 6.

a

National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03

DRUG INTERACTIONS Fluconazole Concomitant administration of Jakafi with fluconazole doses greater than 200 mg daily may increase ruxolitinib exposure due to inhibition of both the CYP3A4 and CYP2C9 metabolic pathways [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Increased exposure may increase the risk of exposure-related adverse reactions. Avoid the concomitant use of Jakafi with fluconazole doses of greater than 200 mg daily except in patients with acute GVHD [see Dosage and Administration (2.4) in Full Prescribing Information]. Strong CYP3A4 inhibitors Concomitant administration of Jakafi with strong CYP3A4 inhibitors increases ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Increased exposure may increase the risk of exposure-related adverse reactions. Consider dose reduction when administering Jakafi with strong CYP3A4 inhibitors [see Dosage and Administration (2.4) in Full Prescribing Information]. In patients with acute GVHD, reduce Jakafi dose as recommended only when coadministered with ketoconazole, and monitor blood counts more frequently for toxicity and adjust the dose if necessary when coadministered with itraconazole. [see Dosage and Administration (2.4) in Full Prescribing Information]. Strong CYP3A4 inducers Concomitant administration of Jakafi with strong CYP3A4 inducers may decrease ruxolitinib exposure [see Clinical Pharmacology (12.3) in Full Prescribing Information]. No dose adjustment is recommended; however, monitor patients frequently and adjust the Jakafi dose based on safety and efficacy [see Clinical Pharmacology (12.3) in Full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy : Risk Summary When pregnant rats and rabbits were administered ruxolitinib during the period of organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity (see Data). There are no studies with the use of Jakafi in pregnant women to inform drug-associated risks. The background risk of major birth defects and miscarriage for the indicated populations is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The background risk in the U.S. general population of major birth defects is 2% to 4% and miscarriage is 15% to 20% of clinically recognized pregnancies. Data: Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There were no treatment-related malformations. Adverse developmental outcomes, such as decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). Lactation: Risk Summary No data are available regarding the presence of ruxolitinib in human milk, the effects on the breast fed child, or the effects on milk production. Ruxolitinib and/or its metabolites were present in the milk of lactating rats (see Data). Because many drugs are present in human milk and because of the potential for thrombocytopenia and anemia shown for Jakafi in human studies, discontinue breastfeeding during treatment with Jakafi and for two weeks after the final dose. Data: Animal Data Lactating rats were administered a single dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and

milk samples were collected for up to 24 hours. The AUC for total radioactivity in milk was approximately 13-fold the maternal plasma AUC. Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma. Pediatric Use The safety and effectiveness of Jakafi for treatment of myelofibrosis or polycythemia vera in pediatric patients have not been established. The safety and effectiveness of Jakafi for treatment of steroid-refractory acute graft-versus-host disease (GVHD) have been established for treatment of children 12 years and older. Use of Jakafi in pediatric patients with steroid-refractory acute GVHD is supported by evidence from an adequate and well-controlled trial of Jakafi in adults [see Clinical Studies (14.3) in Full Prescribing Information] and additional pharmacokinetic and safety data in pediatric patients. Jakafi was evaluated in a single-arm, dose-escalation study (NCT01164163) in 27 pediatric patients with relapsed or refractory solid tumors (Cohort A) and 20 with leukemias or myeloproliferative neoplasms (Cohort B). The patients had a median age of 14 years (range, 2 to 21 years) and included 18 children (age 2 to <12 years), and 14 adolescents (age 12 to <17 years). The dose levels tested were 15, 21, 29, 39, or 50 mg/m2 twice daily in 28-day cycles with up to 6 patients per dose group. Overall, 38 (81%) patients were treated with no more than a single cycle of Jakafi, while 3, 1, 2, and 3 patients received 2, 3, 4, and 5 or more cycles, respectively. A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 dose higher than the recommended dose for adults. The safety profile in children was similar to that seen in adults. Juvenile Animal Toxicity Data Administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. When administered starting at postnatal day 7 (the equivalent of a human newborn) at doses of 1.5 to 75 mg/kg/day, evidence of fractures occurred at doses ≥ 30 mg/kg/day, and effects on body weight and other bone measures [e.g., bone mineral content, peripheral quantitative computed tomography, and x-ray analysis] occurred at doses ≥ 5 mg/kg/day. When administered starting at postnatal day 21 (the equivalent of a human 2-3 years of age) at doses of 5 to 60 mg/kg/day, effects on body weight and bone occurred at doses ≥ 15 mg/kg/day, which were considered adverse at 60 mg/kg/day. Males were more severely affected than females in all age groups, and effects were generally more severe when administration was initiated earlier in the postnatal period. These findings were observed at exposures that are at least 27% the clinical exposure at the maximum recommended dose of 25 mg twice daily. Geriatric Use Of the total number of patients with MF in clinical studies with Jakafi, 52% were 65 years and older, while 15% were 75 years and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Clinical studies of Jakafi in patients with acute GVHD did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Renal Impairment Total exposure of ruxolitinib and its active metabolites increased with moderate (CLcr 30 mL/min to 59 mL/min) and severe (CLcr 15 mL/min to 29 mL/min) renal impairment, and ESRD on dialysis [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Reduce Jakafi dose as recommended [see Dosage and Administration (2.5) in Full Prescribing Information]. Hepatic Impairment Exposure of ruxolitinib increased with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment [see Clinical Pharmacology (12.3) in Full Prescribing Information]. Reduce Jakafi dose as recommended in patients with MF or PV and any hepatic impairment [see Dosage and Administration (2.5) in Full Prescribing Information]. Monitor blood counts more frequently for toxicity and consider 5 mg once daily for patients with Stage 3 or 4 liver GVHD [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) in Full Prescribing Information]. OVERDOSAGE There is no known antidote for overdoses with Jakafi. Single doses up to 200 mg have been given with acceptable acute tolerability. Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anemia and thrombocytopenia. Appropriate supportive treatment should be given. Hemodialysis is not expected to enhance the elimination of Jakafi.

Jakafi is a registered trademark of Incyte. All rights reserved. U.S. Patent Nos. 7598257; 8415362; 8722693; 8822481; 8829013; 9079912; 9814722; 10016429 © 2011-2020 Incyte Corporation. All rights reserved. Revised: August 2020 PLR-JAK-00048


FEATURE 36 | PHYSICIANS OFFICE RESOURCE


Do Your Patients Have to Like You? BY DYLAN CHADWICK

“We’re your parents, not your peers.” That’s the line my folks signed off with many times in response to one of our many disciplinary quarrels. This usually followed me telling them I “hated them” or something equally ridiculous. I was an adolescent once, and though it’s not something I’m proud of, I did what adolescents do. Luckily, my folks could maintain cool heads in such heated situations, seeing clearly that at that moment at least, the nature of our relationship didn’t dictate that we like one another. In fact, what they keyed into was the fact that it was infinitely more important that I respected them and their authority, than it was for me to personally like them. Furthermore, they knew that inasmuch as I was responding to the emotional feelings of injustice that my teenage hormones continually exacerbated, I was just venting emotions. Of course I didn’t actually hate them, nor did I truly think they were “ruining my life” (as I accused them many times). This isn’t about me though, and for the record, my parents and I have a great relationship now. This semantic description, between being liked and respected, has become a sticking point for people, particularly those who must work with customers. The service industry model, one which emphasizes customer service over all else, has bled into numerous other industries, including medicine, and nowhere is this more prevalent than the world of doctor rating sites. Patient Voices Online Nowadays, customers have more opportunities share their own “shopping experiences” than ever, and they can do it with any micro-community they wish. This includes patients and

the various avenues through which they’re getting their health care. These avenues, namely physician rating sites, are fully on the physician radar at this point. Indeed, it’s one of the reasons industry leaders like Kevin Pho continually urge doctors to control their own web presence by creating and managing their own social media and reputation management profiles. The thing is, determining which patient complaints are legitimate, and which ones are merely the result of an unrelated emotional venting, is a very incomplete (and fruitless) science. Furthermore, when a patient feels angry, they can resort to personal criticisms of the physician, ones which are not fair, but are personally hurtful, or even damaging to a professional reputation. While troubling, astute physicians must understand the true nature of these patient ratings, before they react or internalize any charges made against them. When frustrated enough to grind an axe online, patients are often responding to “customer service” issues when voicing complaints about their visit. These can range from dissatisfaction with the physician’s demeanor, a crowded waiting room, difficulty finding the office or simply not being seen as quickly as they were promised. It’s generally not an indictment of a physician’s medical capabilities or intelligence, even if a physician might immediately interpret it that way. Patients, like physicians, are at the mercy of external factors when going about their day. When these external situations start to go awry, it can lead patients to feel there’s a conspiracy against them or will lead to extremely charged feelings that spill over into whatever platform is available. This starts to get 2021, ISSUE 6 | 37


FEATURE

The service industry model, one which emphasizes customer service over all else, has bled into numerous other industries, including medicine, and nowhere is this more prevalent than the world of doctor rating sites.

into non-medical territory like car problems, traffic on the freeways or issues with the kids, and really serve as accents to their actual office visit and the emotions they brought in with them. Should Anyone Worry? Yes and no. The primary point to remember when encountering an unsavory physician review is that, even if unpleasant, it’s an opportunity for self-reflection on pain points within their own practice. It’s also important that physicians maintain enough objectivity that they can see a negative physician review and see it as an opportunity to evaluate, and not become defensive. Internalizing the negativity, or interpreting it as a physical attack, will absolutely not lead anywhere. Physicians should also take negative reviews with a grain of salt, accounting for all the factors outlined above. Getting heated, or even worrying about whether or not a patient “likes” them will not help any situation. It also prevents the physician from making an actual outreach with their patient, one which will identify an opportunity to improve their own performance as a physician. Liked vs. Respected There’s an adage for this whole ordeal and it’s one I’ve already outlines. It’s true though. It’s infinitely better to be liked than respected, and I’m prone to believe that principle applies to healthcare almost more than anywhere else. When a patient respects their physician, they’re far more likely to stick with, and maintain, the health advice and regimens their physicians dispense. Those who do not, or who become offended by a physician’s personality or behavior, are less likely to implement these care instructions, which creates a greater issue for the physician than simply being disliked. Remember, if the goal of dispensing healthcare is for patients to adhere to digestible information and follow it through, 38 | PHYSICIANS OFFICE RESOURCE

then that’s the premiere objective. Sometimes physicians must deliver unpleasant or sensitive information that patients take with much difficulty. While troublesome, they’re often the first step towards creating and fostering improved health care on both the physician and patient ends. Vocabulary Old school sales techniques maintain that the verbiage a clerk uses should invite, rather than prohibit, the customer from an interaction. This means that instead of using absolute terms like “we cannot,” or “That is against our policy,” they should say things like “I’m sorry, how can we correct this?” Now, this is medicine, not buying a new sofa, but some of the same principles apply. A common complaint in the physician rating sphere is that patients felt a physician was simply schilling information onto them, without listening to the patient any further. Rather than using terminology which stops a discussion, it’d serve physicians well to be continually inviting patients to respond to the advice they’re given. This is especially true when a physician has to deliver unpleasant news. In these circumstances, they are obligated to give the patient the opportunity to ask questions, relay their own feelings, and even, vent their personal frustrations with the information. Furthermore, it’s important that physicians recognize that patient complaints are legitimate, even if they’re misguided. Physicians don’t need their patients to actually like them and invite them to all their birthday parties. They must simply be willing to listen and follow their sound medical counsel. — References Ubel, Peter, MD. “Patients Don’t like Their Doctors. Why Is That?”KevinMD.com. KevinMD, 04 Feb. 2015. Web. 13 Feb. 2015.


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Link Your Lab For more information, please call 888.643.8081 or email sales@medicuslis.com

medicuslis.com


“I’M BACK!” RETURN TO NORMAL MEANS RETURN OF RESPIRATORY INFECTIONS DIAGNOSE PATIENTS IN MINUTES

OSOM Flu A&B Special Offer ®

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TO RECEIVE YOUR KITS, SUBMIT REDEMPTIONS ONLINE AT

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PROOF OF PURCHASE REQUIRED ALL REDEMPTIONS MUST BE RECEIVED BY AUGUST 31, 2021

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OSOM® Ultra Flu A&B Test (#1006) Get 6 for 4! 4 Six kits for the price of four (Cat. # 1006) must be purchased on one invoice to qualify. Offer valid on kits purchased May 1, 2021 - July 31, 2021 only

For more information, call 888-616-0537, Option 2 or visit us at osomtests.com SEKISUI Diagnostics reserves the right to change, modify, or discontinue this promotion at its discretion. Please note that the value of the special offer(s) the Customer may receive from the manufacturer under this program is a discount or other reduction in price to Customer under Section 1128B(b)(3)(A) of the Social Security Act (42 U.S.C. 1320a-7b(b)(3)(a)) and 42 C.F.R. 1001.952(h). Accordingly, Customer shall disclose this and any other discounts or other reductions in price received under this program under any state or federal program which provides cost or charge-based reimbursement to the Customer for the products and services purchased under this program. Valid for U.S. end users only, excluding Puerto Rico. © 2021 SEKISUI Diagnostics, LLC. OSOM® and QC Inside® are registered trademarks of SEKISUI Diagnostics, LLC. Because every result matters™ is a trademark of SEKISUI Diagnostics.


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