Physicians office Resource 2019 | Issue 11
™
Resources for You, Your Patients, & Your Practice
The Afinion™ 2 Analyzer Compact, Rapid, Multi-assay Analyzer PAGE 4
The FDA and Laboratory Developed Tests: What’s New? PAGE 12
A Simpler, Better, and Safer Way to Dose Insulin PAGE 6
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 ©2019
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.
7200
7202
7201
TABLE OF CONTENTS
The Afinion™ 2 Analyzer Compact, Rapid, Multi-assay Analyzer
7306
— With its compact size 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. Featuring the first ever point-of-care HbA1c test that can be used as an aid to diagnose or identify patients at risk for diabetes.
6
12
34
DIABETES PATIENT MANAGEMENT: A SIMPLER, BETTER, AND SAFER WAY TO DOSE INSULIN
THE FDA AND LABORATORY DEVELOPED TESTS: WHAT’S NEW
HOW EMOTIONAL DETACHMENT DOESN’T ALWAYS PROTECT PHYSICIANS
Over the years there have been several notable advancements when it comes to insulin therapy. The introduction of analogue insulin’s, “smart” insulin pumps and continuous glucose monitoring systems (CGMS) are just some that quickly come to mind.
The 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&CA) gave the FDA authority to regulate medical devices, including in vitro diagnostic devices (IVDs).
Think about some of the career archetypes in our culture. We expect our police officers, firefighters and other armed servicemen to be bold, selfless and willing to sacrifice their own safety for that of others.
—
4 | PHYSICIANS OFFICE RESOURCE
—
—
MEDICAL DIRECTORS, PROVIDERS AND LABORATORY MANAGERS
NOW YOU CAN FOCUS ON PATIENT LAB TEST OUTCOMES AND NOT WORRY ABOUT HOW TO INTERPRET AND IMPLEMENT CLIA AND ACCREDITATION AGENCY REQUIREMENTS.
my inspection™ software MAKES MEETING laboratory Compliance EASY! IMPLEMENT MY INSPECTION™ SOFTWARE to meet CLIA Waived or Non-Waived compliance requirements. SAVE TIME, MONEY AND ALL EXTRA WORK by reducing paper and eliminating outdated information. USE EXISTING DOCUMENTATION just import your documents into My Inspection™ software. YOUR LAB CAN DO IT TODAY with or without laboratory consultants. If you have a consultant, you can help save time and visits. With remote access, all documentation can be viewed, managed and monitored from any location.
7203
TO MAKE YOUR NEXT LABORATORY INSPECTION EASY – BE INSPECTION READY! CALL 888.534.2977 OR VISIT MYINSPECTION.US TODAY!
™
FEATURE
DIABETES PATIENT MANAGEMENT: A Simpler, Better, and Safer Way to Dose Insulin BY: DAVID KLIFF OF THE DIABETIC INVESTOR Over the years there have been several notable advancements when it comes to insulin therapy. The introduction of analogue insulin’s, “smart” insulin pumps and continuous glucose monitoring systems (CGMS) are just some that quickly come to mind. Coming in the very near future will be insulin pens which talk to a patient’s smartphone and the most promising advancement since the discovery of insulin, insulin dosing algorithms. Algorithms that not only help the patient more effectively dose their insulin, but algorithms which learn allowing them to get even better over time. Let’s face facts, for the majority of patients dosing is basically guess work, especially those who follow multiple daily injection (MDI) therapy. Typically their physician assigns a set amount of basal insulin to be taken each night before bed or each morning before the patient starts their day. The basal insulin is then supplemented with short-acting insulin taken when the patient has a meal or snack, otherwise known as the bolus. In theory the patient would calculate the amount of insulin to take with a Let’s face facts, for the majority of patients dosing is basically guess work, especially those who follow multiple daily injection (MDI) therapy. Typically their physician assigns a set amount of basal insulin to be taken each night before bed or each morning before the patient starts their day. The basal insulin is then supplemented with short-acting insulin taken when the patient has a meal or snack, otherwise known as the bolus. In theory the patient would calculate the amount of insulin to take with a meal based on a multiplicity of factors, such as; · Carb intake
· Duration of Insulin Action
· Target Glucose Range
· Insulin to Carb Ratio’s
· Current Glucose Level
· Insulin on Board
· Time to Action
This is not a complete list but it does explain why so many patients use the WAG (wild ass guess) method dosing their insulin. Yes there are several apps available which can perform the calculation for the patient. However, the apps require the patient enter all the above-mentioned factors so it can make an accurate calculation. Quite frankly the majority of patients either don’t know what to enter or don’t take the time to enter it. For these reasons and to keep insulin dosing simple, many physicians dumb down insulin dosing; telling the patient to dose a set amount with each meal. This may not be the most effective method but as we all know while insulin is a life sustaining drug it is also can be a lethal drug when dosed incorrectly.
6 | PHYSICIANS OFFICE RESOURCE
Thanks to advancements in diabetes device technology we are quickly approaching the day when all the guess work will be taken out of insulin dosing. A day when the system will do all the heavy lifting for the patient who will have just one job, injecting the recommended dose. The cornerstones of these soon to be available systems are an insulin pen which communicates with the patients smartphone, a CGM which also communicates and an insulin dosing algorithm which takes all the data generated by these devices and calculates the amount of insulin a patient should dose. Although no one company has begun marketing a “Tyler,” our term for these connected pen/app/CGM systems, several are under development. Lilly, Novo Nordisk and Sanofi are developing their own version of a Tyler. Systems which will communicate with the two most popular CGM systems the G6 from Dexcom and the Libre from Abbott. Thankfully the CGM component of Tyler are becoming more patient friendly, easier to use and most importantly cheaper. One company, Companion Medical already has an FDA approved connected pen called the inPen which communicates with a smartphone app which also can collect glucose data from a Dexcom CGM. The inPen does not yet come with an insulin dosing algorithm but does offer the patient and their physician a plethora of data which can then be used as a learning tool. Given that Dexcom also owns TypeZero an insulin algorithm, it would not come as shock if one day this algorithm becomes part of the inPen app. No matter which system a patient chooses, one thing is certain: when used as designed all the guess work will be taken out of insulin dosing. Even without these new sophisticated insulin dosing algorithms, several studies have noted that patients using a CGM achieve better outcomes no matter how the insulin is delivered, insulin pen or insulin pump. It stands to given that when insulin dosing algorithms are added these results will get even better. Quite frankly with these advancements we are not going out on a limb when we state that in the very near future it will be easier than ever to be an insulin using patient. Thanks to these learning algorithms all the guess work will be gone. Providing a simpler, better, and safer way to dose insulin.
7204
7205
7206
7207
2019, ISSUE 10 | 7
DRUGS OF ABUSE TESTING AND ROUTINE CHEMISTRY PANELS ON A SINGLE ANALYZER
7208
PRODUCT FOCUS
From Carolina Liquid Chemistries Carolina Liquid Chemistries Corp. announces the successful launch of Medica Corporation’s high-speed benchtop analyzer, the EasyRA®. The updated analyzer now operates at a photometric rate of up to 240 tests per hour or up to 480 tests per hour with ISE. The EasyRA urine drug screening and general chemistry reagents are CLIA categorized as moderately complex. This all-in-one system allows clinical laboratories to screen for drugs of abuse in urine while also allowing healthcare providers to assess routine chemistry panels on a single analyzer.
View Brochures, Videos & More at POR.io Enter Number 7208 in the Search Area
MICROS ES 60 HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL
7209
From HORIBA Medical Simple to use and easy to maintain with a zero maintenance concept, the Micros ES 60 is a small tabletop hematology analyzer with an integrated data management system. The analyzer provides a CBC with 3-part differential 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 7209 in the Search Area
7210
PENTRA 60 C+ HEMATOLOGY ANALYZER WITH 5-PART DIFFERENTIAL From HORIBA Medical Now you can have the same results hospitals and reference labs provide in a small, benchtop analyzer. The Pentra 60 C+ hematology analyzer provides a CBC with 5-part differential result using proprietary technology that ensures an accurate count and differential on the first run. Reduce repeats and reflex to the microscope with Pentra hematology technology.
View Brochures, Videos & More at POR.io Enter Number 7210 in the Search Area
8 | PHYSICIANS OFFICE RESOURCE
7211
THE SILARIS® RSV TEST From Sekisui Diagnostics The Silaris® RSV Test is a molecular diagnostic test utilizing polymerase chain reaction (PCR) technology providing accurate results to aid in early diagnosis and proper management of RSV. The system is easy to use, compact, portable and CLIA Waived so you can test and treat in one visit.
View Brochures, Videos & More at POR.io Enter Number 7211 in the Search Area
COST-EFFECTIVE AI MEDICAL SCRIBE From Phraze
7212
Are you frustrated with spending more time writing notes than seeing patients? Has the EHR become a “screen between” you and your patients? Are you interested in having a medical scribe, but find that the cost is prohibitive? Phraze’s is a cost-effective AI Medical Scribe software that analyzes the conversation between you and your patient. It then automatically produces a clinical note that is as beautiful as it is intelligent: saving you time and improving your connection to patients.
—
View Brochures, Videos & More at POR.io Enter Number 7212 in the Search Area
THE RX IMOLA 7213
From Randox A fully automated, random access analyzer with STAT sampling functionality; boosting productivity and saving time when it matters most. Developed for mediumhigh throughput laboratories, the RX imola provides comprehensive testing with the world-class RX series test menu, including specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing. The RX imola: A cost-effective system that delivers consistent high quality results with a small footprint.
View Brochures, Videos & More at POR.io Enter Number 7213 in the Search Area
2019, ISSUE 10 | 9
7214
PRODUCT FOCUS
FULLY AUTOMATED QUANTITIVE IMMUNOASSAY ANALYZER 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 7214 in the Search Area
MICROS HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL PLUS THE LITEDM
7215
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 7215 in the Search Area
7216
FIRST EVER CLIA WAIVED HEMATOLOGY ANALYZER From Sysmex Faster test results, clinical decisions and greater practice efficiency are coming to physicians’ offices with the first CLIAwaived CBC analyzer. Hematology diagnostics leader Sysmex is bringing more lab testing to the point of care. One of the most common blood tests can be conducted reliably and accurately on-site, in as few as three minutes. The device’s ease of use and innovative technology means in-house staff can operate it in just a few easy steps, without lengthy certification and training. The new Sysmex XW-100 will improve health care efficiency and patient care. —
View Brochures, Videos & More at POR.io Enter Number 7216 in the Search Area
10 | PHYSICIANS OFFICE RESOURCE
7217
™
MINIIMIZE THE HASSLE OF ESR TESTING IN YOUR LAB The miniiSED™ requires just 100µL of sample to provide fast, accurate, and reliable ESR results in just 15 seconds!
FEATURE
The FDA and Laboratory Developed Tests:
WHAT’S NEW? BY IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP), TECHNICAL WRITER /QUALITY ADVISOR, COLA RESOURCES, INC.
HISTORICAL PERSPECTIVE The 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&CA) gave the FDA authority to regulate medical devices, including in vitro diagnostic devices (IVDs). Defined as reagents, instruments, and systems intended for use in diagnosing disease or other conditions, IVDs are packaged products developed and distributed by medical device manufacturers and sold in interstate commerce. In regulating IVDs, the FDA focuses on their safety and efficacy, the manufacturer claims about clinical “intended use” of the devices, and the quality of the design and manufacturing process1. In contrast with IVD products, the Clinical Laboratory Improvement Amendments of 1988 (CLIA), administered through the Centers for Medicare & Medicaid Services (CMS), regulates clinical laboratories’ performance and reporting of laboratory tests for human patient diagnosis and management. CLIA focuses on the accuracy and reli12 | PHYSICIANS OFFICE RESOURCE
ability of the testing process, with attention to analytic quality control, proficiency testing, the credentials of laboratory testing personnel, requirements for reporting results, and appropriate documentation of standard operating procedures. CLIA allows clinical laboratories to modify FDA-approved tests, and, more importantly, to develop their own tests—laboratory-developed tests (LDTs)—as long as they follow the requirements to validate the performance characteristics of the LDTs. Routine, regular inspections under the auspices of CLIA are intended to ensure that these necessary steps are being followed for the LDTs offered for patient care purposes. In the past, laboratory developed tests have also been referred to as “in-house” tests. Often, a laboratory will choose to develop and use an
LDT because a commercial test is not available. LDTs generally have not been subjected to FDA oversight because these diagnostic tests are never sold to other laboratories or hospitals. Historically, LDTs comprised a relatively small volume of tests that were relatively simple, intended for use in diagnosing rare diseases or to meet the needs of a local patient population. However, unlike traditional LDTs, modern LDTs are more complex; widely used to screen for common high-risk diseases, such as breast cancer and Alzheimer’s disease, rather than rare diseases; manufactured in high volume laboratories by large corporations with international reach and offered beyond local patient populations; and present higher risks than those of other IVDs that have undergone premarket review (e.g., used in guiding critical treatment decisions). In light of these profound shifts in the technology and business practices with respect to the use of LDTs, the FDA currently believes that its policy of general enforcement discretion towards LDTs may no longer be appropriate. As a result, the FDA has begun to revisit its role in the regulation of LDTs. There appear to be two main factors presently causing increased concern on the part of the FDA: the use of LDTs in the exponentially growing field of molecular diagnostics, including pharmacogenetics, which includes tests that are used to assess high-risk conditions and supply information for critical decision-making; and the increasing number of LDTs being manufactured by corporations with far-reaching markets rather than hospitals serving local populations. These commercial companies, many with their own CLIA-certified laboratories, offer direct-to-consumer (DTC) genetic testing. The FDA has become increasingly concerned about the use of improperly clinically validated tests that may pose a public health risk. The FDA has also expressed concern that the current lab accrediting agencies are focused on test analytical validity, and not the clinical validity and use of the tests, making FDA oversight necessary2. There can be several reasons why a commercial test has not been developed for a particular analyte or disease of interest. For example, many LDTs are genetic tests developed for rare diseases. These are also diseases affecting only small subset of the population, thus reducing the incentive for a manufacturer to develop a commercial version because the market for such a product would be small, without a potential decent return on investment. Or, an existing test may not apply to a particular subpopulation from which the lab has patients, so modification of the test is required. (Any FDA-approved commercial test that is modified in any way by a lab is considered to be a laboratory-developed test and is subject to the regulations applied to all lab-developed tests.)3 THE CURRENT LANDSCAPE Estimates suggest that thousands of diagnostic tests, including the majority of genetic tests, are currently offered as LDTs. The list of testing which is currently being performed almost exclusively by LDTs includes
newborn screening; diagnosis of genetic defects, including metabolic disorders; infectious disease testing, especially viral load testing for diseases such as HIV, CMV, EBV, and respiratory viruses; immune-histochemical stains for the diagnosis of cancers; tandem mass spectrometry, testing for a wide variety of analytes ranging from thyroid tests to immunosuppressant drugs to vitamin D; next generation gene sequencing; comparative genomic hybridization array testing; genetic variants of the Cytochrome P450 drug metabolism system and determination of appropriate individual drug dosing; and drug screening and confirmation assays,(pharmacogenetics) to name a few.4 DIRECT TO CONSUMER TESTING Commercial companies, many with their own CLIA-certified laboratories, now offer direct-to-consumer (DTC) genetic tests. Such tests give consumers information about their own genetic markers, from physical traits (such as baldness) to certain disease associations (such as prostate cancer). The identification of these “genome-wide disease associations” has become increasingly popular among consumers. Although, many of these disease associations are weak to moderate at best, there is a growing list of companies offering this kind of information on an increasing number of conditions. The important distinction that needs to be made is that these tests offer “prediction” through statistical possibilities. They do not provide statistical certainties—a critical point that can easily be lost in translation in the marketing and consumer use of such products. Furthermore, prediction does not equal diagnosis. Because there are frequently so many other genetic and environmental factors that can determine whether a disease actually emerges, it is critical that consumers fully understand that the risk may never become reality. Similarly, the absence of a genetic risk factor (or the presence of a favorable one) may still not prevent subsequent development of disease. This context about the known association between a disease and genetic markers must be clearly communicated to the consumer through counseling—done best by medical professionals, particularly professionals trained in medical genetics.5 The fact that many of these DTC companies develop their own tests and testing platforms has led the FDA, as well as members of Congress, to believe that these LDTs are medical devices that must be carefully regulated so that the analytic and clinical validity and clinical usefulness are clearly understood, to protect the public safety. Accordingly, additional regulatory safeguards, provided by FDA IVD oversight to ensure the accuracy of LDTs, particularly high-risk LDTs, have been under consideration for several years to better ensure that patients do not seek unnecessary treatments, delay needed treatments or become exposed to inappropriate therapies.
Continue reading online at PhysiciansOfficeNews.com. 2019, ISSUE 10 | 13
PRODUCT FOCUS
CLIA-WAIVED BIOFIRE® FILMARRAY® RESPIRATORY PANEL (RP) EZ 7218
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.
—
View Brochures, Videos & More at POR.io Enter Number 7218 in the Search Area
PAD TESTING SYSTEMS IDEAL FOR PRIMARY CARE TO VASCULAR SPECIALISTS From Newman Medical Your patients Trust You to find their PAD • You have many high risk patients, including anyone over 65 or diabetics or smokers • Even if they are unaware of their PAD, 25% will have a heart attack or stroke within 5 years if not managed • Patients often mistake symptoms of PAD for arthritis. simpleABI Cuff-Link systems are easy to learn and use • Push button remote, automatic calculations/waveforms • PC based – reports are easy to save and share Excellent Value and Reimbursements • One test per week pays off system in less than one year • Medicare reimbursements range from $80 to $220 depending on location and test
7219
View Brochures, Videos & More at POR.io Enter Number 7219 in the Search Area
THE RX DAYTONA+ 7220
From Randox A bench-top, fully automated, random-access chemistry analyzer, providing routine and specialized testing with emergency STAT sampling functionality. Demonstrating unparalleled versatility, the RX daytona+ combines robust hardware and intuitive software with the world-class RX series test menu, including specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing. The RX daytona+ ensures unrivalled precision, reliability and accuracy for results you can trust.
View Brochures, Videos & More at POR.io Enter Number 7220 in the Search Area
14 | PHYSICIANS OFFICE RESOURCE
7221
Jacob’s birthday party No, my migraine wants me to lie down in the dark Yes, I will attend
Š 2019 Teva Pharmaceuticals USA, Inc.
FRE-41678
March 2019
Less migraine. More moments.
TM
Help patients say yes to more moments AJOVY® (fremanezumab-vfrm) injection is the only anti-CGRP treatment for the prevention of migraine with quarterly and monthly dosing options1 More migraine-free days with AJOVY in clinical trials1
INDICATION
AJOVY is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy. Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions. Please see Brief Summary of full Prescribing Information on the following page.
To learn more, visit AJOVYhcp.com
CGRP: calcitonin gene-related peptide. Reference: 1. AJOVY® (fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc. 2019, ISSUE 10 | 17
BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR AJOVY® (fremanezumab-vfrm) injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE AJOVY is indicated for the preventive treatment of migraine in adults. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage: • 225 mg monthly, or • 675 mg every 3 months (quarterly), which is administered as three consecutive subcutaneous injections of 225 mg each. When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. If a dose of AJOVY is missed, administer as soon as possible. Thereafter, AJOVY can be scheduled from the date of the last dose. 2.2 Important Administration Instructions AJOVY is for subcutaneous use only. AJOVY may be administered by healthcare professionals, patients, and/or caregivers. Prior to use, provide proper training to patients and/or caregivers on the preparation and administration of AJOVY prefilled syringe, including aseptic technique [see Instructions for Use in full Prescribing Information]: • Remove AJOVY from the refrigerator. Prior to use, allow AJOVY to sit at room temperature for 30 minutes protected from direct sunlight. Do not warm by using a heat source such as hot water or a microwave. Do not use AJOVY if it has been at room temperature for 24 hours or longer. • Follow aseptic injection technique every time AJOVY is administered. • Inspect AJOVY for particles or discoloration prior to administration. Do not use if the solution is cloudy, discolored, or contains particles. • Administer AJOVY by subcutaneous injection into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, you may use the same body site, but not the exact location of the previous injection. • Do not co-administer AJOVY with other injectable drugs at the same injection site. 4 CONTRAINDICATIONS AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumabvfrm or to any of the excipients [see Warnings and Precautions (5.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY, and institute appropriate therapy. 6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice. The safety of AJOVY was evaluated in 2512 patients with migraine who received at least 1 dose of AJOVY, representing 1279 patient-years of exposure. Of these, 1730 patients were exposed to AJOVY 225 mg monthly or AJOVY 675 mg quarterly for at least 6 months, 775 patients for at least 12 months, and 138 patients for at least 15 months. In placebo-controlled clinical trials (Studies 1 and 2), 662 patients received AJOVY 225 mg monthly for 12 weeks (with or without a loading dose of 675 mg), and 663 patients received AJOVY 675 mg quarterly for 12 weeks. In the controlled trials, 87% of patients were female, 80% were White, and the mean age was 41 years. The most common adverse reactions in the clinical trials for the preventive treatment of migraine (incidence at least 5% and greater than placebo) were injection site reactions. The adverse reactions that most commonly led to discontinuations were injection site reactions (1%). Table 1 summarizes adverse reactions reported in the 3-month placebo-controlled studies (Study 1 and Study 2), and the 1-month follow-up period after those studies. Table 1: Adverse Reactions Occurring with an Incidence of At Least 2% for Either Dosing Regimen of AJOVY and At Least 2% Greater Than Placebo in Studies 1 and 2 Placebo AJOVY AJOVY Monthly 225 mg Monthly 675 mg Quarterly (n=668) (n=667) (n=290) % % % Injection site reactionsa 43 45 38 a Injection site reactions include multiple related adverse event terms, such as injection site pain, induration, and erythema. Adverse Reaction
AJOVY® (fremanezumab-vfrm) injection 6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to fremanezumab-vfrm in the studies described below with the incidence of antibodies in other studies to other products may be misleading. Clinical immunogenicity of AJOVY was monitored by analyzing anti-drug antibodies (ADA) and neutralizing antibodies in drug-treated patients. The data reflect the percentage of patients whose test results were positive for antibodies to AJOVY in specific assays. In 3-month placebo-controlled studies, treatment-emergent ADA responses were observed in 6 out of 1701 (0.4%) AJOVY-treated patients. One of the 6 patients developed anti-AJOVY neutralizing antibodies at Day 84. In the ongoing long-term open-label study, ADA were detected in 1.6% of patients (30 out of 1888). Out of 30 ADA-positive patients, 17 had a neutralizing activity in their post-dose samples. Although these data do not demonstrate an impact of antifremanezumab-vfrm antibody development on the efficacy or safety of AJOVY in these patients, the available data are too limited to make definitive conclusions. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. AJOVY has a long half-life. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. Administration of fremanezumab-vfrm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development [see Animal Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Animal Data When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse embryofetal effects were observed. The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg. Administration of fremanezumab-vfrm (0, 10, 50, or 100 mg/kg) weekly by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development. The highest dose tested was associated with plasma AUC approximately 3 times that in humans (675 mg). Administration of fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) weekly by subcutaneous injection to female rats throughout pregnancy and lactation resulted in no adverse effects on pre- and postnatal development. The highest dose tested was associated with plasma AUC approximately 2 times that in humans (675 mg). 8.2 Lactation Risk Summary There are no data on the presence of fremanezumab-vfrm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AJOVY and any potential adverse effects on the breastfed infant from AJOVY or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of AJOVY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 US License No. 2016 ©2019 Teva Pharmaceuticals USA, Inc. This Brief Summary is based on the full Prescribing Information for AJOVY AJO-002.
FRE-41620
March 2019
ACUCY INFLUENZA A&B TEST From Sekisui Diagnostics 7222
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.
View Brochures, Videos & More at POR.io Enter Number 7222 in the Search Area
CLIA-WAIVED FOR RAPID DETECTION OF FLU A+B From BD Veritor
7223
The CLIA-Waved BD Veritor™ Plus System for rapid detection of Flu A+B, combines speed and accuracy. It provides clear digital results in under 11 minutes and has demonstrated performance compared to molecular tests.[1] It is easy to use and has a low cost of ownership. The BD Veritor ™ Plus System is CLIA-Waved for Flu, RSV and Group A Strep. [1] (BD Veritor System for Rapid Detection of Flu A+B, CLIA-waved kit package insert, 8087667 (14) 2018-06. BD Veritor System for Rapid Detection of Flu A+B, laboratory kit package insert, 8087666 (11) 2017-10., 2018-06.)
View Brochures, Videos & More at POR.io Enter Number 7223 in the Search Area
7224
MINÍÍMIZE THE HASSLE OF ESR TESTING IN YOUR LAB From ALCOR Scientific miniiSED™ is the newest of the iSED® family of ESR analyzers from ALCOR Scientific. The miniiSED™ measurement of ESR is accurate and unaffected by variables associated with traditional methodologies, such as hematocrit. This single position, fully automated ESR analyzer works directly from primary EDTA tubes, requires 100 μL of sample, has an internal barcode reader, and produces results in 15 seconds! miniiSED™ is the ideal solution to ESR testing for small laboratories, POL’s, and emergency clinics. Proudly manufactured in the USA.
View Brochures, Videos & More at POR.io Enter Number 7224 in the Search Area
2019, ISSUE 10 | 19
PRODUCT FOCUS
RELIABLE DETECTION OF STREP A, FLU A, FLU B AND RSV From Cepheid Cepheid’s GeneXpert Xpress® brings standardized molecular testing to any healthcare setting. Employing the highly accurate and easy to use lab in a cartridge technology in every GeneXpert system, the GeneXpert Xpress® is a true on-demand walkaway testing system that provides accurate and reliable detection of Strep A, Flu A, Flu B and RSV. Two or four-module configurations save valuable bench space and reduce the need for multiple testing platforms.
7225
View Brochures, Videos & More at POR.io Enter Number 7225 in the Search Area
MAKE LABORATORY COMPLIANCE AND INSPECTION EASIER From My Inspection Make laboratory compliance and inspections easier by changing how you document, save and retrieve all information necessary to meet CLIA and accreditation regulations. With two unique electronic tools My Compliance Manual and MyInspection™ Software, the guesswork and tedious task of interpreting and documenting policy, procedure, forms, charts and logs is over. Your lab will be compliant, have less paper, and be inspection ready.
View Brochures, Videos & More at POR.io Enter Number 7226 in the Search Area
7226
BIOFIRE® FILMARRAY® TORCH From BioFire 7227
The BioFire® FilmArray® Torch is a fully integrated, random, and continuous access system designed to meet your laboratory’s syndromic infectious disease testing needs. The BioFire Torch offers a radically reduced benchtop footprint, saving precious space in the lab, and its scalability meets high throughput demands. BioFire® FilmArray® Link Software automatically uploads patient results. Fully compatible with all CLIA Moderate BioFire® FilmArray® Panels, the BioFire Torch helps you maximize efficiency and productivity.
View Brochures, Videos & More at POR.io Enter Number 7227 in the Search Area
20 | PHYSICIANS OFFICE RESOURCE
Systems for Clinical Laboratories, Large and Small CHEMISTRY
7228
IMMUNOASSAY
HEMATOLOGY
SMALL PRACTICES / BENCHTOP
7229
7230
BC-3600 Chemistry: Up to 240 photometric tests/hr; 400 tests/hr with ISE
Immunoassay: Up to 36 tests/hr
Hematology: Up to 60 samples/hr 3-Part Diff
MIDSIZE GROUP PRACTICES 7231
7232
7233
BC-5390 Chemistry: Up to 400 photometric tests/hr; 800 tests/hr with ISE
With 9-Tray Sorter Immunoassay: Up to 90 tests/hr
Hematology: Up to 60 samples/hr 5-Part Diff
LARGE GROUP PRACTICES AND SMALL HOSPITALS 7234
7235
7236
BC-5390 Chemistry: Up to 900 photometric tests/hr; 1,200 tests/hr with ISE
With 19-Tray Sorter Immunoassay: Up to 90 tests/hr
Hematology: Up to 60 samples/hr 5-Part Diff
www.carolinachemistries.com contactsales@carolinachemistries.com
877-722-8910 POR_back_cover_ad.00 JUN 2019
PRODUCT FOCUS
7237
IDEAL SYSTEM FOR LOW-TO-MODERATE VOLUME LABORATORIES From Sekisui Diagnostics The SK™500 chemistry instrument and SEKURE Reagents offer an ideal system for low-to-moderate volume laboratories seeking exceptional throughput with minimal use of space and water. The SK500 is a compact and efficient instrument with a full menu of reagents specifically designed for and packaged for the system
View Brochures, Videos & More at POR.io Enter Number 7237 in the Search Area
PORTABLE, SINGLE CLICK OPERATION SPIROMETER 7238
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 7238 in the Search Area
THE BREWER BASIC EXAM TABLE From Brewer Full featured, entry-level exam table design. The Brewer Basic Exam Table features a pneumatic cylinder, seamless upholstery, and the largest storage capacity available. We invite you to compare features, price, warranty and you will find the Brewer Basic Exam Table is clearly the best entry level exam table available.
View Brochures, Videos & More at POR.io Enter Number 7239 in the Search Area
22 | PHYSICIANS OFFICE RESOURCE
7239
7240
7241
7242
7244
7245
7246
7248
7249
7250
7243
7247
7251
7254
7252
7255
7253
7256
7257
7258
7259
2019, ISSUE 10 | 23
PRODUCT FOCUS
ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OFCARE LIPID TESTING From Abbott The CLIA-waived Alere Cholestech LDX™ Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing. Results are easy to obtain. Fingerstick sampling and a small sample size (40μL) makes results less painful and time consuming.
7260
View Brochures, Videos & More at POR.io Enter Number 7260 in the Search Area
SELF-CONTAINED DIAGNOSTIC WORKSTATION From Vitalograph Vitalograph introduces the Compact Expert diagnostic workstation. The device is a full touch-screen based medical workstation, which comes equipped with Vitalograph’s flagship Pneumotrac spirometer. This accurate, robust and linear Fleisch pneumotach produces over 50 spirometry parameters, automatically stores all test data, calibration data and clinical audit trail data in a secure network capable SQL Server database. An intuitive user interface enhances the routine workflow in most practices, allowing quick patient throughput. Beyond spirometry, it is a desktop testing station for ECG, Pulse Oximetry, Weight , COPD assessment, and Blood Pressure measurements.
7261
View Brochures, Videos & More at POR.io Enter Number 7261 in the Search Area
ACCUTEST PH® PHENAPHTHAZINE PAPER From Jant Pharmacal Test papers give instant, easy-to-read results, with clear, bright matches at 0.5 intervals from pH 4.5 to 7.5. Color charts are lab-tested for precision accuracy. Made in the U.S.A. with stateof-the-art materials. An FDA-listed medical test product, used in hospitals and doctor’s offices around the world. Economical – approximately 100 tests/roll. Widely used in hospitals and doctors’ offices to detect the presence of amniotic fluid in vaginal secretions during late-term pregnancy, a sign of premature amniotic sac rupture.
View Brochures, Videos & More at POR.io Enter Number 7262 in the Search Area 7262 24 | PHYSICIANS OFFICE RESOURCE
Get more of the story, faster. Improve patient flow with on-site, syndromic gastrointestinal disease testing from BioFire. Waiting hours or days for laboratory results for gastroenteritis can make patient management decisions complicated. The BioFireÂŽ FilmArrayÂŽ Gastrointestinal (GI) Panel simultaneously tests for 22 of the most commonly associated pathogens related to gastroenteritis. And now, tests can be performed right in the office.*
Faster Diagnosis. Better Patient Care. Shorten Time to Results With results in about one hour, you can diagnose patients faster and possibly reduce further medical follow-up. Improve Operational Efficiency The BioFire GI Panel is easy-to-use, it takes just two minutes of hands-on time and 0.2 mL sample in Cary Blair. Prescribe the Right Treatment Improve your Antimicrobial Stewardship Program by aiding in more accurate and timely diagnosis and potentially reducing unnecessary antibiotic prescriptions.
7263
biofiredx.com
*CLIA moderate complexity certification is required
BFR0000-2962-01
7264
FIRE YOUR FINANCIAL ADVISOR
PRODUCT FOCUS
From White Coat Investor Fire Your Financial Advisor is the course that should’ve been taught to you in college, medical school, or residency but never was. For 1/10th the price and half the time of hiring a professional financial planner, this course will take you from feeling anxious and having no plan to having a written financial plan you can follow the rest of your investing career as a professional and a retiree. Topics covered include insurance, investing, retirement planning, and much more. Learn more at whitecoatinvestor.com.
View Brochures, Videos & More at POR.io Enter Number 7264 in the Search Area
SINGLE, INTEGRATED POC TESTING SOLUTION From Abbott Point of Care The fully automated i-STAT System offers a broad menu of tests for diagnostic and treatment indicators related to disease state management and clinical practice guidelines. Using just 2 or 3 drops of blood, the system provides time-sensitive tests at the patient’s side in just minutes.
7265
View Brochures, Videos & More at POR.io Enter Number 7265 in the Search Area
7266
THE BREWER CENTURY SERIES STOOL From Brewer Has a pneumatic height adjustment, 16” wide, 4” thick poly-foam seat cushion, and five-leg 23” brushed aluminum accent base. Optional adjustable 18” chrome footing. Optional adjustable contoured backrest with black plastic shroud.
View Brochures, Videos & More at POR.io Enter Number 7266 in the Search Area
26 | PHYSICIANS OFFICE RESOURCE
Take advantage of these HOT fall deals!
Save your cash. Ask us about exible leasing options. Purchase a Micros ES 60 3-Part Diff Hematology Analyzer and a LiteDM Data Management System, get three extra connections1 at no additional charge
+
=
7267
Connect up to 4 analyzers with one LiteDM Includes connections for the Micros 60 and any 3rd party analyzers of your choice where connections are already available
Micros ES 60 3-Part Diff LiteDM Patient Data Management Hematology Analyzer
Purchase a Pentra 60C+ or a Pentra XL80 5-Part Diff Hematology Analyzer, get service at no additional charge when you purchase Calibrators and Controls for 60 months 7268
Pentra 60 C+ 5-Part Diff Hematology Analyzer
Pentra XL80+ 5-Part Diff Hematology Analyzer
Purchase a Pentra C400 Chemistry Analyzer, 7269 get a Micros 60 3-Part Diff Hematology Analyzer and a LiteDM Data Management System at no additional charge
+ Pentra C400 Chemistry Analyzer
+ Micros 60 3-Part Diff Hematology Analyzer
All offers expire December 31, 2019. All terms and conditions apply. 1 Connections must be installed at time of analyzer installation
= LiteDM Patient Data Management
One Great Deal!
To request pricing and more information, e-mail medical-marketing.US@horiba.com
Contact Horiba Medical at 888-280-1401 • medical-marketing.US@horiba.com
7270
PRODUCT FOCUS
BREWER’S FLEX™ ACCESS EXAM TABLE From Brewer Step up to power table performance for less with Brewer’s Flex™ Access Exam Table. Industry-leading 700-lb. patient weight capacity, unique safety features and unmatched ergonomic patient access maximize your clinical efficiency and ROI. A streamlined footprint and optional upgrades like safety grab bars, stirrups, and pass-through work surface provide ultimate flexibility for your practice.
View Brochures, Videos & More at POR.io Enter Number 7270 in the Search Area
DEFINING MOBILE TELEDIAGNOSTICS From MedPod With the ability to deploy into a medical office in less than 2 minutes, MobileDoc is the ultimate portable practice. Revolutionary in its compact and mobile design, MobileDoc integrates best-in-class professional medical-grade devices with state-of-the-art HD video and EHR connectivity. Physicians can provide care remotely that is on par or better than a face-to-face visit, including conducting basic exams, checking vitals, and performing specialty testing— shattering the boundaries of traditional care.
7271
View Brochures, Videos & More at POR.io Enter Number 7271 in the Search Area
7272
ULTRA HCG COMBO TEST From Sekisui Diagnostics The OSOM® Ultra hCG Combo test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Internal studies have confirmed that the OSOM® Ultra hCG Combo test does not have a false negative result from hCG variants providing physicians with a higher level of confidence.
View Brochures, Videos & More at POR.io Enter Number 7272 in the Search Area
28 | PHYSICIANS OFFICE RESOURCE
7273
Bionet CardioCare 2000: $1,255.00 Schiller AT-2 Plus: $2,275.00* *add Spirometry: $1,000.00 Burdick ELI 250c: $3,422.00 Welch Allyn CP150 w/ Interp: $3,258.00
The Adview 2 is still the only truly modular diagnostic station that grows with your needs. Start with blood pressure and choose temperature or 7274 pulse oximetry option at the time of purchase.
7275 7276
7277
7279
7278
7281
7282
7284
7285
7286
Coaxial Ophth, Fiber Optic Oto, Speucla Dispenser, Aneroid BP, Wall Transformer and Wall Board without Thermometer: $979.00 with Thermometer: $1,416.00
7280
7283
PRODUCT FOCUS
TURN SMALL PLACES INTO SMART SPACES From Abbott
7287
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 7287 in the Search Area
MEMORY LOSS BIOMARKERS TO AID IN DIAGNOSIS IN PRIMARY CARE PRACTICES From Evoke Neuroscience The eVox® System is an FDA 510(k) cleared medical device to aid primary and specialty care physicians in diagnosis of memory loss and other cognitive disorders. eVox® measures memory loss biomarkers that may aid in detecting memory loss sooner, identifying the root cause of memory loss, and performing a differential diagnosis. eVox® procedures are performed in-office and are reimbursable by Medicare and commercial payers.
7288
View Brochures, Videos & More at POR.io Enter Number 7288 in the Search Area
OPTIMIZE PRODUCTIVITY AND EXPAND YOUR PRACTICE From MedPod
7289
The Medpod Medical Cart optimizes productivity and load balancing by enabling access to remote physicians during high volume periods or to reach low-density populations. Medpod’s proprietary software integrates with a wide range of professional medical devices and gives the remote provider control of the devices to conduct an examination that is on par with a faceto-face visit. Patient images, audio and data can be captured, annotated, tagged and uploaded in real-time or stored and forwarded into the EHR by either remote or local provider.
View Brochures, Videos & More at POR.io Enter Number 7289 in the Search Area
30 | PHYSICIANS OFFICE RESOURCE
A better way.
They’re Here Flu, RSV, Strep. Be Ready.
With confirmatory molecular results,
Cepheid’s CLIA Waived test menu delivers peace of mind to you and your patients.
7290
7291
7292
Xpert® Xpress Flu/RSV
Xpert® Xpress Flu
Xpert® Xpress Strep A
• One sample. One Cartridge. Three results
• Qualitative, molecular detection and differentiation of influenza A and B
• Accurate, real-time PCR molecular testing for Group A Strep
• Qualitative, molecular detection and differentiation of influenza A, influenza B and RSV
• Sample types include nasal swab and nasopharyngeal swab
• Internal QC in each cartridge
• Room Temperature reagent storage
• No confirmation required for negative results*
• Sample types include Nasal swab and Nasopharyngeal swab
For more information, call (888) 256-6990 For in vitro diagnostic use. * No culture confirmation required for negative results unless clinical symptoms persist, or there is an outbreak of acute rheumatic fever (ARF). 904 Caribbean Drive | Sunnyvale, CA 94089 USA | TOLL FREE +1.888.336.2743 | PHONE +1.408.541.4191 | FAX +1.408.541.4192 | www.cepheid.com
PRODUCT FOCUS
CLIA-WAIVED COMPREHENSIVE METABOLIC PANEL From Abbott Point of Care The Piccolo Xpress™ point-of-care chemistry analyzer delivers comprehensive CLIA waived diagnostics to Physician Offices. In 3 easy steps, the Piccolo provides lab-accurate results in minutes from a menu of 29 general chemistry tests, including lipids, liver, kidney, metabolic and other specialty functions. By using only 100 microliters of whole blood, serum or plasma - physicians can make confident treatment decisions faster, thereby increasing the efficiency, throughput and capacity of their practice, while also increasing revenue and ensuring patient satisfaction.
View Brochures, Videos & More at POR.io Enter Number 7293 in the Search Area
7293
SPOTCHEM™ EZ CHEMISTRY ANALYZER From Jant Pharmacal
7294
SPOTCHEM™ EZ chemistry analyzer is a small bench top chemistry analyzer that utilizes dry chemistry technology to test whole blood. Results are available on the SPOTCHEM™ printer or downloaded via LIS. SPOTCHEM™ is ideally suited for small laboratories and physician offices that desire an easy-touse analyzer with a small footprint. Maximum throughput is 48 tests per hour. Test menu includes 21 tests and 3 panels. Tests whole blood, serum or plasma with rapid results within 4 – 15 minutes. Extensive CLIA-waived menu, includes lipid panel, creatinine, AST, ALT, glucose, and 2 chemistry panels. Automatic calibration.
View Brochures, Videos & More at POR.io Enter Number 7294 in the Search Area
HISTOFREEZER® PORTABLE CRYOSURGICAL SYSTEM From OraSure - Histofreezer Histofreezer® Portable Cryosurgical System offers medical professionals an easy and effective method to treat nine different types of skin lesions, including common, plantar and genital warts and other common benign skin lesions. Medical professionals in primary care, internal medicine, podiatry, ob/gyn and dermatology areas of care have either added Histofreezer® to their practice offering or replaced more invasive and less tolerated procedures with Histofreezer®.
7295
32 | PHYSICIANS OFFICE RESOURCE
View Brochures, Videos & More at POR.io Enter Number 7295 in the Search Area
7297 6986
6985 7296
#5316
Call 888-522-9939 or Visit medpod.por.io for More Information
FEATURE
HOW EMOTIONAL DETACHMENT DOESN’T ALWAYS PROTECT PHYSICIANS BY: DYLAN CHADWICK Think about some of the career archetypes in our culture. We expect our police officers, firefighters and other armed servicemen to be bold, selfless and willing to sacrifice their own safety for that of others. We expect our clerks and sales representatives to be prompt, friendly and helpful, our teachers to be knowledgeable and our technicians and tradesman to be competent. These are all classic, broad-brush definitions for how we evaluate these individuals as members of a community, as well as keen indicators for job proficiency. Now, think about a physician. What’s the “classic” doctor archetype? Calm and collected? Able to make life and death decisions (sometimes literally), to deliver harrowing news and to call upon delicate surgical prowess, even under extreme duress? How about emotive and warm? Approachable? Emotionally competent and able to reach out and fully connect with patients?
the embodiment of the term “clinical.” However, it’s what Osler says next that has some re-evaluating the paradigm for physician behavior. “A rare and precious gift, is the art of detachment.”
Indeed, the modern physician must be a veritable combination of all these traits as societal expectations and circumstances evolve, but to understand much of physician culture we can look to Sir William Osler, the father of modern medicine, for examples. Per Osler, physicians should “demonstrate imperturbability,” or more clearly defined “coolness and presence of mind under all circumstances.” Essentially,
In his article Is Your Model of Physician Behavior Out of Date, Leigh Page suggests that many physicians justify their detachment, or aloofness, under the banner of “efficiency.” They insist that such levels of detachment are necessary for proper patient-doctor interactions, and prove ultimately most beneficial to both parties. He also calls this act a “double edged sword” in that the types of detachment which insulate
34 | PHYSICIANS OFFICE RESOURCE
Detachment Late 19th and early 20th century biases aside, there’s still much truth to what Osler says, but how much? In many cases, detachment is a profoundly beneficial defense mechanism for physicians under stress. When strong diagnoses must be delivered, feelings, fears and emotions can run at an elevated and exacerbated level. It takes a practiced physician to maintain poise and cool in delivering these heady diagnoses and to develop an action plan with a patient, all without being drawn into a detrimental emotional tail-spin. But some levels of detachment are far too critical.
physicians from anger, rage and hostility under potent circumstances, may also be insulating them from having real and important connecting experiences with patients down the line. Furthermore, it may have an eroding effect on their personal lives. “Detachment isn’t like a light switch that can be turned on and off to suit a specific situation,” he says. “It has a tendency to seep into all relationships. It becomes a personal style of distancing oneself from the world, not just from patients but also colleagues, family, friends and yourself.” What Goes Wrong Detached attitudes prevent physicians from truly empathizing with patients...a crucial ingredient in cultivating physician compliance and ongoing doctor-patient trust. While a doctor-patient relationship may still exist on a technicality in that they’re both sitting in a room together, detached doctors speak in a way which is over patient’s heads, they fail to check for understanding and become fixated on the external stimuli like the clock or upon getting patients in and out of the door. The precursor to burnout Physician Burnout is a condition defined by Cardiologist Seth Bilazarian, MD as “physical or mental stress, or mental collapse, caused by overwork or stress.” Physicians reach dangerous levels of burnout when they ignore their own frustrations, stay separated from their own feelings and don’t reach out for help. It’s at a rising tide too. One widely cited survey in Paige’s article finds that 50% of physicians will suffer at least one symptom of serious burnout this year. Another comparable survey finds that 87% of physicians felt moderate to severe burnout and 66% (2/3) of those surveyed claimed that the phenomenon has become more prevalent than it was only 3 years ago. Physician burnout most certainly has adverse impacts on patient care. One study finds that burned out physicians commit more surgical errors than those who aren’t. Herdley O. Paolini, PhD is a psychologist who works as a director of the Florida Hospital Physician Support Services Program at Flordia Hospital in Orlando, and ends up treating an average of 35 physicians each week for burnout and burnout related symptoms. Burnout “has to do with depersonalizing yourself and others,” Paolini says. “Doctors face a lot of trauma, but the trauma doesn’t make them sick. It’s their inability to process the trauma. They just tough it out, even if makes them physically sick.” Speaking on Errors As is human nature, it’s difficult for physicians to talk about their mistakes. Physicians may believe in a myth of perfection, and many don’t deal with any errors in an upfront way. Additionally, many physicians keep the knowledge of errors to themselves, fearing a lawsuit or some kind of other disciplinary action. Unfortunately, surgical errors have a significant, and emotionally destabilizing effect on physicians and their performance. A 2007 survey of physicians who committed medical errors found that 61% of them reported substantial anxiety about making future errors, 44% of them felt a loss of confidence in their medical judgment, 42% felt a loss of confidence regarding their own medical judgment and 42% reported decreased job satisfaction. The tendency after committing an error is to become extremely cautious, which often results in overusing tests or distracted clinical decision making. Essentially, more detachment and a vicious cycle that only breeds more of it is born. An orthopedic survey of surgeons
found that 96% practiced defensive medicine, which accounted for an additional $100,000 per year in extra costs per surgeon for tests and other surgeons. Breaking the detachment-burnout cycle While physicians may have difficulty coping with their own perception of imperfection, the fact is that emotional isolation only exacerbates the situation. Taking great pains to mask discomfort, to secretly nurture the feelings of guilt over a patient’s lack of improvement or even death, or the continued belief that by maintaining emotionally distant from patients they can protect themselves from trauma, will germinate into severe levels of burnout and less effective patient care and greater ancillary costs. Paolini says that some situations, even negative ones simply need to be accepted. In her book What Doctors Feel: How Emotions Affect the Practice of Medicine, author Danielle Ofri, MD and Associate Professor of Medicine at New York University School of Medicine, insists that medical errors have a tendency to get blown out of proportion, doing more damage to the physician than the patient. “Usually the only person who knows about the error is the doctor, and the only way anyone finds out is when the doctor comes forward.” The overall solution is, first and foremost, that physicians have emotions. While their efforts are often nothing short of heroism, and the job demands can be stressful and at times extreme, they must acknowledge their own feelings, especially when they’re negative. Perhaps this means channelling them in positive ways like writing them down in a journal, consulting a trusted medical mentor or even something as innocuous as exercise. The treatment is often much simpler than the symptom, it’s just important that it is acknowledged. The doctor to patient relationship is primarily a human one. When humans connect on an emotional level, they “weave an underlying framework of interaction, empathy and concern” which goes a long way towards healing both patient and doctor (What Physicians Feel, Orfi). All things should be taken in moderation and extremes in any belief tend to do more harm than good. The key isn’t to get too emotionally invested, nor is it to detach too much. Doctors need to care for their patients in a genuine way that doesn’t violate any boundaries, and this means processing trauma in healthy ways. In 2013 as we soldier ahead with medical developments, technology and new avenues for patient care, the human factor is still what helps heal patients. Detached physicians may think they’re doing something responsible in the immediate stages, but in the long run they may be doing more damage to themselves and to their patients. Medicine strives to be a rigorous science. But it is more often, as Dr. Sherwin Nuland calls it, “an uncertain art.” Doctors and patients have piles of data at their disposal, but how to use this information is not always clear-cut. Owning up to this uncertainty to themselves and to their patients isn’t not easy, but it is the more effective approach. REFERENCES Grappone, Amy. “Uncertainty and the Doctor-Patient Relationship.” Countingupfromzero.com. N.p., 8 June 2013. Web. 14 July 2013. Orfi, Danielle. “Uncertainty Is Hard for Doctors.” Blogs.nytimes.com. New York Times, 6 June 2013. Web. 14 July 2013. Ofri, Danielle. What Doctors Feel: How Emotions Affect the Practice of Medicine. Boston: Beacon, 2013. Print. Page, Leigh. “How Doctors’ Feelings Affect Their Patients’ Care.” Medscape.com. Medscape, 20 June 2013. Web. 14 July 2013.
2019, ISSUE 10 | 35
PRODUCT FOCUS
PENTRA XLR HEMATOLOGY ANALYZER WITH 5-PART DIFFERENTIAL
7298
From HORIBA Medical The Pentra XLR hematology analyzer with autoloader provides a CBC with 5-part Diff result using proprietary technology that ensures an accurate count and differential on the first run. The Pentra XLR also provides a complete menu of Retic parameters for treating oncology and anemia patients. The autoloader processes 80 samples an hour and provides random continuous access for mediumto high-volume clinics and rural or community hospitals.
View Brochures, Videos & More at POR.io Enter Number 7298 in the Search Area
HEMATOLOGY TESTING MADE EASY From Sysmex Designed for labs testing up to 25 samples per day, the Sysmex pocH-100i™ has the smallest footprint of any analyzer on the market. The instrument requires only 15uL of whole blood for reporting of 17 clinical parameters, including a 3-part WBC Differential. It is ideal for urgent care, physician office lab, small clinic, or any outpatient setting where a point of care CBC is needed.
7299
View Brochures, Videos & More at POR.io Enter Number 7299 in the Search Area
SYSMEX XN-L™ SERIES AUTOMATED HEMATOLOGY ANALYZERS From Sysmex
7300
Now lower volumne customers can enjoy the same capabilities in CBC testing as larger hospitals and reference labs. Enhanced clinical value is standard and optional licenses for reticulocyte or body cluid testing are available. The XN-L analyzers are the first to feature BeyondCareSM Quality Monitor, an innovative, webbased QC and calibration management program.
View Brochures, Videos & More at POR.io Enter Number 7300 in the Search Area
36 | PHYSICIANS OFFICE RESOURCE
It's flu season. Which test are you using?
Simplify workflow, results and patient management. The CLIA-Waived BD Veritor™ Plus System for Rapid Detection of Flu A+B simplifies workflow and provides clear and quick results for appropriate patient management within the same visit. • One button functionality, easy to use and implement • Unambiguous digital flu result in under 11 minutes* • Demonstrated performance compared to molecular tests1 • Low cost of ownership
Simply the right POC test for influenza, Group A Strep and RSV.†
7301
Request a demo today at go.bd.com/VeritorPOR *Results after 10-minute incubation period for Flu A+B and RSV; after 5-minute incubation period for Group A Strep † RSV- Respiratory Syncytial Virus References: 1. BD Veritor System for Rapid Detection of Flu A+B, CLIA-waived kit package insert, 8087667 (14) 2018-06. BD Veritor System for Rapid Detection of Flu A+B, laboratory kit package insert, 8087666 (11) 2017-10.
BD, 7 Loveton Circle, Sparks, MD 21152-0999 USA Tel: 1.888.211.6980 1.800.638.8663
© 2018 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
40
2019, ISSUE 10 | 37 www.PhysiciansOfficeResource.com
PENTRA C400 CHEMISTRY ANALYZER
7302
PRODUCT FOCUS
From HORIBA Medical One benchtop, not a whole lab! No water system, drain or special electrical connected required to operate the Pentra C400 chemistry analyzer. Now you can have the power of a floor model analyzer on the benchtop! The Pentra C400 chemistry system processes up to 420 tests/hr including ISEs and offers routine metabolic assays, TDMs, DAUs and Adulterants, HbA1c and Vitamin D tests. With 40 open channels, you can add much more for a complete menu to meet your practice needs.
View Brochures, Videos & More at POR.io Enter Number 7302 in the Search Area
LASER LIPO–NON-INVASIVE INSTANT INCH LOSS RESULTS
7303
From Laser Lipo Ltd The FDA Approved, Strawberry Laser Lipo is a ground-breaking treatment offering non-invasive, instant inch loss results to the Abdomen, Hips, Thighs, Arms, Back Fat, Buttocks, Male Chest and Knees, without any pain or downtime. The clinically proven, noninvasive laser treatment penetrates the skin to selectively target the fat cells underneath, leaving blood vessels, nerves and other tissue undisturbed. Only $24,750 and 0% in-house no credit check financing.
View Brochures, Videos & More at POR.io Enter Number 7303 in the Search Area
SILARIS™ INFLUENZA A&B TEST From Sekisui Diagnostics
7304
A molecular test utilizing polymerase chain reaction (PCR) technology providing accurate results for early diagnosis and proper management of influenza. Accurate • Molecular Results • State-of-the art microfluidic cassette technology • PCR test using proprietary OscAR™ Technology Affordable • Single Test Diagnosis • Controls in every kit • Molecular reimbursement (CPT Code 87502) Simple • Easy to Use • Compact portable dock with no calibration required • Room temperature storage
View Brochures, Videos & More at POR.io Enter Number 7304 in the Search Area 38 | PHYSICIANS OFFICE RESOURCE
YOU BELONG AT FOUR SEASONS ANGUILLA OWNERSHIP AS EASY AS THE ISLAND ITSELF Here on the welcoming island of Anguilla, the turquoise water and azure blue sky meet in harmonious accord. You anticipate the peace of Anguilla before you ever get on the plane, and upon arrival your remaining cares simply roll away with the Caribbean tide. World-renowned Four Seasons service and carefree luxury are yours to enjoy. We welcome you home. You belong.
DELUXE STUDIOS TO 5 BEDROOM VILLAS FROM $825,000 TO OVER $10 MILLION TO FIND OUT MORE OR PLAN A DISCOVERY WEEKEND, CALL +1 800 901 7079 OR EMAIL US AT INFO@ANGUILLAPRIVATERESIDENCES.COM
AnguillaPrivateResidences.com
This offer is not directed to residents in any state in which a registration is required but in which registration requirements have not yet been met, including, but not limited to, New Jersey. Recreational features and amenities described herein are subject to change periodically. Warning: the California Department of Real Estate has not examined this offering, including, but not limited to, the condition of title, the status of blanket liens on the project (if any), arrangements to assure project completion, escrow practices, control over project management, racially discriminatory practices (if any), terms, conditions, and price of the offer, control over annual assessments (if any), or the availability of water, services, utilities, or improvements. It may be advisable for you to consult an attorney or other knowledgeable professional who is familiar with real estate and a law in the country where this subdivision is situated. In New York, the complete offering terms are in an offering plan available from sponsor. File no. CD11-1029 (Resort Residences) and fi le no. H11-0007 (Villas). Four Seasons Private Residences Anguilla are not owned, developed or sold by Four Seasons Hotels limited or its affi liates (Four Seasons). The developer, an affi liate of Starwood Capital Group, uses the Four Seasons trademarks and tradenames under a license from Four Seasons Hotels limited. The marks “FOUR SEASONS,” “FOUR SEASONS HOTELS AND RESORTS,” any combination thereof and the Tree Design are registered trademarks of Four Seasons Hotels Limited in Canada and U.S.A. and of Four Seasons Hotels (Barbados) Ltd. elsewhere. © 2019
NEW
TURN SMALL PLACES INTO SMART SPACES 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 mid-size clinical laboratories with: • Compact design maximizes valuable laboratory space • Ease of use and walkaway functionality optimizes staff time • Smart open tube sample device ensures user safety
7305
41 cm
Visit www.corelaboratory.abbott/hematology to learn how the new CELL-DYN Emerald 22 AL can help your laboratory operate more efficiently. 50 cm
C HOOSE TRAN S FORMATI ON
TM
Achieve measurably better healthcare performance.
CELL-DYN Emerald 22 AL is a Class 1 laser. For in vitro diagnostic only. Refer to the Operator’s Manual for operational precautions, limitations, and hazards. CELL-DYN Emerald and CHOOSE TRANSFORMATION are trademarks of Abbott Laboratories in various jurisdictions. CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory. © 2019 Abbott Laboratories. ADD-00064842.