Vo l u m e x X I X , N o . 11 F e b r u a r y 2 016
Change management Anticipation vs. reaction By Todd Archbold, LSW, MBA
Chronic disease spending in Minnesota Analyzing the All Payer Claims Database By Edward Ehlinger, MD, MSPH
new report from the Minnesota Department of Health (MDH) shows the significant financial toll chronic disease is taking on individuals, our communities, and our state. It also serves as a powerful reminder that as we struggle to adapt to an aging population and rising health care costs, we cannot afford to treat our way out of this chronic disease crisis.
The high cost of spending For the first time, Minnesota can place dollar figures on the state’s chronic disease spending thanks to data gathered from the Minnesota All Payer Claims Database (MN APCD). In 2012, Minnesota’s total bill for chronic disease was $22.7 billion. That means insured residents with one or Chronic disease spending in Minnesota to page 16
t was the Greek philosopher Heraclitus who was known for his doctrine that change is central to the universe. Among his many writings, he stated that nothing remains the same and everything changes. Now, nearly 2,500 years later, managers in all aspects of business continue to philosophize about the best ways to understand and manage change. We could say that one thing has in fact remained unchanged, and that is our constant struggle to understand and manage change. Managing change has traditionally been characterized by using psychological and behavioral tactics to manipulate processes or systems, such as using the “carrot and stick” method of motivation. However, change is more successfully managed through thoughtful multi-dimensional assessments and using tactics deployed through understanding and engineering technical measures. An example may be using a root cause analysis to determine how or where an error in a process originated, and how it impacted related systems. Understanding and managing change Health care is a rapidly changing industry faced with pressures from political, social, financial, and ethical forces. Innovation in technology and the digitization of our information and care delivery has created both challenges and
Change management to page 18
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November 2015 Minnesota Physician
February 2016 • Volume XXIX, Number 11
MInnESotA HEALtH CArE roUnDtABLE
Features Chronic disease spending in Minnesota Analyzing the All Payer Claims Database
By Edward Ehlinger, MD, MSPH
Change management Anticipation vs. reaction By Todd Archbold, LSW, MBA
Health care economics Stefan Gildemeister Minnesota Department of Health
The VA medical system By Hanna E. Bloomfield, MD, MPH
Electronic health record systems By Timothy A. Johnson, JD, and Julia C. Marotte, JD
Medical Innovation vs. Medical Economics When payment policies limit quality of life
Special Focus: Allied Providers Direct access to physical therapy By Craig Johnson, PT, MBA
Advanced practice nursing in Minnesota 22 By Julie Sabo, PhD(c), APRN, CNS
Speech and language development By Mark DeRuiter, PhD; Linda Hinderscheit, MA; and Marilyn Fairchild, MA
Thursday, April 21, 2016 • 1:00-4:00 PM
Acupuncture, pain, and integrative care 26 By Karen Lawson, MD, ABIHM, and John Blaska, DAOM
Professional Update: Emergency Medicine Dying from prescription heroin By Chris Johnson, MD
Downtown Minneapolis Hilton and Towers
Publisher Mike Starnes | email@example.com Editor Lisa McGowan | firstname.lastname@example.org Associate Editor Richard Ericson | email@example.com Art Director Joe Pfahl | firstname.lastname@example.org Office Administrator Amanda Marlow | email@example.com Advertising Stacey Bush | firstname.lastname@example.org Advertising Linda Nervick | email@example.com
Background and Focus: The pace of innovation in medical science is rapidly escalating. From more accurate diagnostic equipment, to the use of genomic data, to better surgical techniques and medical devices, to new and more efficacious pharmaceuticals, breakthroughs occur nearly every day. These advances face many challenges when incorporated into medical practice. Several significant factors limit this adoption, including the economic models around how patient use of new science will be utilized. Twentieth century health insurance, medical risk management, and reimbursement models are controlling 21st century medical care and patients are the losers. Objectives: We will review examples of recent scientific advances and the difficulties they face when becoming part of best medical practice, despite their clear superiority over existing norms. We will look at prevailing thinking behind economic models that govern how health care is paid for today. Our panel of industry experts will explore potential solutions to these problems. We will look at ways to create balance between payment models, new technology, and increased quality of life. Please send me tickets at $95.00 per ticket. Tickets may be ordered by phone at (612) 728-8600, by fax at (612) 728-8601, on our website (mppub. com), or by mail. Make checks payable to Minnesota Physician Publishing. Mail orders to MPP, 2812 East 26th Street, Mpls, MN 55406. Please note: tickets are non-refundable. Name Company Address City, State, ZIP Telephone/FAX Card #
Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@ mppub.com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc. or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.
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February 2016 Minnesota Physician
Minnesota Physician February 2016
It clicked when my doctor and I discussed Trulicity 速1,2
Trulicity is a GLP-1 RA therapy that offers proven glycemic control, once-weekly dosing, and the Trulicity pen.*1 If you have patients who struggle with the idea of adding an injectable, consider Trulicity as an option for the next step in their care.1,3 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional A1C reduction. * In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose; the percentage of patients achieving A1C <7% ranged from 37% to 69% for 0.75 mg and 53% to 78% for 1.5 mg.1,4-7
Trulicity is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only if potential benefits outweigh potential risks. Has not been studied in patients with a history of pancreatitis; consider another antidiabetic therapy. Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not for patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with basal insulin.
Select Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.
Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on next page and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.
Learn about proven glycemic control with fewer injections at Trulicity.com
February 2016 Minnesota Physician
Trulicity® is an injectable option that may click with your patients
A GLP-1 RA therapy that offers:
Proven glycemic control*1
The Trulicity pen
* In clinical studies, the range of A1C reduction from baseline was 0.7% to 1.6% for the 0.75 mg dose and 0.8% to 1.6% for the 1.5 mg dose; the percentage of patients achieving A1C <7% ranged from 37% to 69% for 0.75 mg and 53% to 78% for 1.5 mg.1,4-7 Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg.
Once-weekly Trulicity delivered results across clinical trials A1C from baseline A1Creduction reduction from baseline Add-on to metformin (26 weeks)
Add-on to metformin (52 weeks)
Add-on to metformin and Actos® (26 weeks)
Add-on to metformin and Amaryl® (52 weeks)
Compared to Victoza®4
Compared to Januvia®1,8,9
Compared to Byetta®1,10
Compared to Lantus®1,6,11,12
MeanA1C A1Cchange change from from baseline Mean baseline(%) (%)
0.0 -0.2 -0.4
Victoza (1.8 mg) (n=300; Baseline A1C: 8.1%)
Januvia (100 mg) (n=273; Baseline A1C: 8.0%)
Placebo (n=141; Baseline A1C: 8.1%)
Trulicity® (1.5 mg) (n=299; Baseline A1C: 8.1%)
Trulicity® (0.75 mg) (n=281; Baseline A1C: 8.2%)
Byetta (10 mcg BID) (n=276; Baseline A1C: 8.1%)
Trulicity (0.75 mg) (n=272; Baseline A1C: 8.1%)
Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)
Trulicity (0.75 mg) (n=280; Baseline A1C: 8.1%)
Trulicity (1.5 mg) (n=273; Baseline A1C: 8.2%)
26-week, randomized, open-label comparator phase 3 study
104-week, randomized, placebo-controlled, double-blind
• 104-week, randomized, placebo-controlled, 26-week, randomized, open-label phase 3 study of adult patients with type 2 diabetes treated of adult patients with type 2 diabetes treated with metformin with metformin mg/dayof adult patients mg/day comparator≥1500 phase 3 study of adult double-blind phase≥1500 3 study • Primary objective was to demonstrate noninferiority of • Primary objective was to demonstrate noninferiority of patients with type 2 diabetes treated with type 2 diabetes treated with metformin Trulicity 1.5 mg vs Januvia on A1C change from baseline at Trulicity 1.5 mg vs Victoza 1.8 mg on A1C change from baseline with metformin ≥1500 52 weeks (-1.1% vs -0.4%, respectively; difference of -0.7%; at 26 weeks (-1.42% mg/day vs -1.36%, respectively; difference of ≥1500 -0.06%; mg/day 95% CI [-0.19, 0.07]; 2-sided alpha level of 0.05 for noninferiority
95% CI [-0.9, -0.5]; multiplicity-adjusted 1-sided alpha level
52-week, randomized, placebo-controlled phase 3 study
5. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1)
endpoint of[published superiority was notin met correction appears Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37:2159-2167.
6. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2) [published online ahead of print June 18, 2015]. Diabetes Care. doi:10.2337/dc14-1625. 7. Data on file, Lilly USA, LLC. TRU20140912A. 8. Data on file, Lilly USA, LLC. TRU20150313A.
78-week, randomized, open-label comparator phase 3 study
• 78-week, randomized, open-label comparator 52-week, randomized, placebo-controlled (open-label assignment to Byetta or blinded assignment to (double-blind with respect to Trulicity dose assignment) of adult Trulicity or adult patients with type 2 diabetes to patientsphase with type3 2 diabetes with maximally tolerated phase 3 placebo) studyof(open-label assignment studytreated (double-blind with respect to treated with maximally tolerated metformin (≥1500 mg/day) metformin (≥1500 mg/day) and Amaryl (≥4 mg/day) Byetta assignment to Trulicity or Trulicity dose assignment) of adult patients and Actosor (upblinded to 45 mg/day) • Lantus titration was based on self-measured fasting plasma of adult typeof2 diabetes glucosewith 2 diabetes treated with24% maximally •placebo) Primary objective was topatients demonstratewith superiority utilizingtype an algorithm with a target of <100 mg/dL; Trulicity 1.5with mg vsmaximally placebo on change in A1C from metformin baseline of patients were titratedmetformin to goal at the 52-week primarymg/day) endpoint and treated tolerated tolerated (≥1500 at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; objective was to demonstrate (≥1500 mg/day) and Actos1-sided (up toalpha 45level mg/day)• Primary Amaryl (≥4 mg/day)noninferiority of Trulicity 95% CI [-1.2, -0.9]; multiplicity-adjusted 1.5 mg vs Lantus titrated to target on A1C change from baseline at
• Primaryofobjective Primary objective was to model demonstrate was towith demonstrate 0.025 for noninferiority 0.25% margin; analysis of margin 0.4%; mixed repeated measures analysis) covariance of using last observation [LOCF]); noninferiority ofobjective Trulicity 1.5 mg for vsA1C reduction wasnoninferiority Trulicity 1.5 carried mg vsforward Januvia • Primary of noninferiority met; primary objective met of 0.025; analysis of covariance using LOCF); primary of superiority was not met • Primary Victoza 1.8secondary mg onendpoint A1C change from on A1C change from baseline at 52 weeks objective was to demonstrate objective met baseline at 26 weeks (-1.42% vs -1.36%, (-1.1% vs -0.4%, respectively; difference of superiority of Trulicity 1.5 mg vs placebo on respectively; difference of -0.06%; 95% CI -0.7%; 95% CI [-0.9, -0.5]; multiplicitychange in A1C from baseline at 26 weeks References [-0.19, 0.07]; 2-sided alphaST,level ofal.0.05 adjusted 1-sided of 0.025 for -0.5%,a respectively; difference 1. Dungan KM, Povedano Forst T, et Once-weekly dulaglutide versus once-dailyalpha liraglutidelevel in metformin-treated patients with type (-1.5% 2 diabetesvs (AWARD-6): randomised, open-label, phase 3, non-inferiority trial [published 2014;384:1348]. Lancet. for noninferiority margin 0.4%;correction mixedappears in Lancet. noninferiority with 2014;384:1349-1357. 0.25% margin; analysis of -1.1%; 95% CI [-1.2, -0.9]; multiplicity2. Trulicity [Prescribing Information]. Indianapolis, IN: Lillyof USA, LLC; 2015. model repeated measures analysis) covariance using last observation carried adjusted 1-sided alpha level of 0.025; 3. Data on file, Lilly USA, LLC. TRU20150203A. forward [LOCF]); primary objective met analysis of covariance using LOCF); primary • Primary objective of noninferiority for 4. Data on file, Lilly USA, LLC. TRU20150203B. objective met A1C reduction was met; secondary •
Lantus (n=262; Baseline A1C: 8.1%)
Trulicity (1.5 mg) (n=279; Baseline A1C: 8.1%)
Data represent least-squares mean ± standard error.
52 weeks (-1.1% vs -0.6%, respectively; 1-sided • Lantus titration wasmultiplicity-adjusted based on self-measured alpha level of 0.025 for noninferiority with 0.4% margin; analysis of fasting plasma covariance using LOCF); primaryglucose objective metutilizing an
algorithm with a target of <100 mg/dL; 24% of patients were titrated to goal at the 52-week primary endpoint
• Primary objective was to demonstrate
noninferiority of Trulicity 1.5 mg vs Lantus titrated to target on A1C change from baseline at 52 weeks (-1.1% vs -0.6%, respectively; multiplicity-adjusted 1-sided alpha level of 0.025 for noninferiority with 0.4% margin; analysis of covariance using LOCF); primary objective met
Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, on the following page and accompanying Brief Summary of Prescribing Information. Please see Instructions for Use included with the pen.
Minnesota Physician February 2016
Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS
In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components. Risk of Thyroid C-cell Tumors: Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist (GLP-1 RA), have been reported in the postmarketing period; the data in these reports are insufﬁcient to establish or exclude a causal relationship between MTC and GLP-1 RA use in humans. If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated. Pancreatitis: Has been reported in clinical trials. Observe patients for signs and symptoms including persistent severe abdominal pain. If pancreatitis is suspected, discontinue Trulicity promptly. Do not restart if pancreatitis is conﬁrmed. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia: The risk of hypoglycemia is increased when Trulicity is used in combination with insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia. Hypersensitivity Reactions: Systemic reactions were observed in patients receiving Trulicity in clinical trials. Instruct patients who experience symptoms to discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 RAs, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, sometimes requiring hemodialysis. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In patients with renal impairment, use caution when initiating or escalating doses of Trulicity and monitor renal function in patients experiencing severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug.
0.75 mg, and Trulicity 1.5 mg) were nausea (5.3%, 12.4%, 21.1%), diarrhea (6.7%, 8.9%, 12.6%), vomiting (2.3%, 6.0%, 12.7%), abdominal pain (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), and fatigue (2.6%, 4.2%, 5.6%). Gastric emptying is slowed by Trulicity, which may impact absorption of concomitantly administered oral medications. Use caution when oral medications are used with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to a clinically relevant degree. Pregnancy: There are no adequate and well-controlled studies of Trulicity in pregnant women. Use only if potential beneﬁt outweighs potential risk to fetus. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established and use is not recommended in patients less than 18 years of age. Please see Brief Summary of Prescribing Information, including Boxed Warning about possible thyroid tumors including thyroid cancer, on following pages. Please see Instructions for Use included with the pen. DG HCP ISI 20APR2015 Trulicity® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Trulicity is available by prescription only. Actos® is a registered trademark of Takeda Pharmaceutical Company Limited. Byetta® is a registered trademark of the AstraZeneca group of companies. Amaryl® and Lantus® are registered trademarks of Sanofi-Aventis. Januvia® is a registered trademark of Merck & Co., Inc. Victoza® is a registered trademark of Novo Nordisk A/S. Other product/company names mentioned herein are the trademarks of their respective owners. References 1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2015. 2. Trulicity [Instructions for Use]. Indianapolis, IN: Lilly USA, LLC; 2014. 3. Polonsky WH, Hajos TR, Dain MP, Snoek FJ. Are patients with type 2 diabetes reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population. Curr Med Res Opin. 2011;27(6):1169-74. doi: 10.1185/03007995.2011.573623. Epub Apr 6, 2011. 4. Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial [published correction appears in Lancet. 2014;384:1348]. Lancet. 2014;384:1349-1357. 5. Umpierrez G, Tofé Povedano S, Pérez Manghi F, et al. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014;37:2168-2176. 6. Giorgino F, Benroubi M, Sun JH, et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2) [published online ahead of print June 18, 2015]. Diabetes Care. doi:10.2337/dc14-1625. 7. Blonde L, Jendle J, Gross J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015;385:2057-2066. 8. Data on file, Lilly USA, LLC. TRU20150203A. 9. Data on file, Lilly USA, LLC. TRU20150203B. 10. Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1) [published correction appears in Diabetes Care. 2014;37:2895]. Diabetes Care. 2014;37:2159-2167. 11. Data on file, Lilly USA, LLC. TRU20140912A. 12. Data on file, Lilly USA, LLC. TRU20150313A.
The most common adverse reactions reported in ≥5% of Trulicitytreated patients in placebo-controlled trials (placebo, Trulicity
10/2015 PRINTED IN USA
©Lilly USA, LLC 2015. All rights reserved.
February 2016 Minnesota Physician
TrulicityTM (dulaglutide) Brief Summary: Consult the package insert for complete prescribing information. WARNING: RISK OF THYROID C-CELL TUMORS • In male and female rats, dulaglutide causes a dose-related and treatmentduration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. • Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of Trulicity and inform them of symptoms of thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity.
insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting. Hypersensitivity Reactions: Systemic hypersensitivity reactions were observed in patients receiving Trulicity in clinical trials. If a hypersensitivity reaction occurs, the patient should discontinue Trulicity and promptly seek medical advice. Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Because these reactions may worsen renal failure, use caution when initiating or escalating doses of Trulicity in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Severe Gastrointestinal Disease: Use of Trulicity may be associated with gastrointestinal adverse reactions, sometimes severe. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Trulicity or any other antidiabetic drug. ADVERSE REACTIONS
INDICATIONS AND USAGE Trulicity™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Risk of Thyroid C-cell Tumors: In male and female rats, dulaglutide causes a doserelated and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether Trulicity will cause thyroid C-cell tumors, including MTC, in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined. One case of MTC was reported in a patient treated with Trulicity. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN). Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans. Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of Trulicity and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Trulicity. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated. Pancreatitis: In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis-related adverse reactions were reported in patients exposed to Trulicity versus 3 in non-incretin comparators (2.7 cases per 1000 patient years). An analysis of adjudicated events revealed 5 cases of confirmed pancreatitis in patients exposed to Trulicity (1.4 cases per 1000 patient years) versus 1 case in non-incretin comparators (0.88 cases per 1000 patient years). After initiation of Trulicity, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, promptly discontinue Trulicity. If pancreatitis is confirmed, Trulicity should not be restarted. Trulicity has not been evaluated in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: The risk of hypoglycemia is increased when Trulicity is used in combination with
Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Pool of Placebo-controlled Trials: These data reflect exposure of 1670 patients to Trulicity and a mean duration of exposure to Trulicity of 23.8 weeks. Across the treatment arms, the mean age of patients was 56 years, 1% were 75 years or older and 53% were male. The population in these studies was 69% White, 7% Black or African American, 13% Asian; 30% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.0 years and had a mean HbA1c of 8.0%. At baseline, 2.5% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60mL/min/1.73 m2) in 96.0% of the pooled study populations. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Trulicity-Treated Patients: Placebo (N=568), Trulicity 0.75mg (N=836), Trulicity 1.5 mg (N=834) (listed as placebo, 0.75 mg, 1.5 mg): nausea (5.3%, 12.4%, 21.1%), diarrheaa (6.7%, 8.9%, 12.6%), vomitingb (2.3%, 6.0%, 12.7%), abdominal painc (4.9%, 6.5%, 9.4%), decreased appetite (1.6%, 4.9%, 8.6%), dyspepsia (2.3%, 4.1%, 5.8%), fatigued (2.6%, 4.2%, 5.6%). (a Includes diarrhea, fecal volume increased, frequent bowel movements. b Includes retching, vomiting, vomiting projectile. c Includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, gastrointestinal pain. d Includes fatigue, asthenia, malaise.) Note: Percentages reflect the number of patients that reported at least 1 treatment-emergent occurrence of the adverse reaction. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving Trulicity than placebo (placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%). More patients receiving Trulicity 0.75 mg (1.3%) and Trulicity 1.5 mg (3.5%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.2%). Investigators graded the severity of gastrointestinal adverse reactions occurring on 0.75 mg and 1.5 mg of Trulicity as “mild” in 58% and 48% of cases, respectively, “moderate” in 35% and 42% of cases, respectively, or “severe” in 7% and 11% of cases, respectively. In addition to the adverse reactions ≥5% listed above, the following adverse reactions were reported more frequently in Trulicity-treated patients than placebo (frequencies listed, respectively, as: placebo; 0.75 mg; 1.5 mg): constipation (0.7%; 3.9%; 3.7%), flatulence (1.4%; 1.4%; 3.4%), abdominal distension (0.7%; 2.9%; 2.3%), gastroesophageal reflux disease (0.5%; 1.7%; 2.0%), and eructation (0.2%; 0.6%; 1.6%). Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 6 placebo- and active-controlled trials evaluating the use of Trulicity as monotherapy and add-on therapy to oral medications or insulin. In this pool, a total of 3342 patients with type 2 diabetes were treated with Trulicity for a mean duration 52 weeks. The mean age of patients was 56 years, 2% were 75 years or older and 51% were male. The population in these studies was 71% White, 7% Black or African American, 11% Asian; 32% were of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.2 years and had a mean HbA1c of 7.6-8.5%. At baseline, 5.2% of the population reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 ml/min/1.73 m2) in 95.7% of the Trulicity population. In the pool of placebo- and active-controlled trials, the types and frequency of common adverse reactions, excluding hypoglycemia, were similar to those listed as ≥5% above. Other Adverse Reactions: Hypoglycemia: Incidence (%) of Documented Symptomatic (≤70 mg/dL Glucose Threshold) and Severe Hypoglycemia in Placebo-Controlled Trials: Add-on to Metformin at 26 weeks, Placebo (N=177), Trulicity 0.75 mg (N=302), Trulicity 1.5 mg (N=304), Documented symptomatic: Placebo: 1.1%, 0.75 mg: 2.6%, 1.5 mg: 5.6%; Severe: all 0. Add-on to Metformin + Pioglitazone at 26 weeks, Placebo (N=141), Trulicity 0.75 mg (N=280), Trulicity 1.5 mg (N=279), Documented symptomatic: Placebo: 1.4%, 0.75 mg: 4.6%, 1.5 mg: 5.0%; Severe: all 0. Hypoglycemia was more frequent when Trulicity was used in combination with a sulfonylurea or insulin. Documented symptomatic hypoglycemia occurred in 39% and 40% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Severe hypoglycemia occurred in 0% and 0.7% of patients when Trulicity 0.75 mg and 1.5 mg, respectively, was co-administered with a sulfonylurea. Documented symptomatic hypoglycemia occurred in 85% and 80% of patients when Trulicity 0.75 mg
Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe Trulicity only to patients for whom the potential benefits outweigh the potential risk. Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. It is not a substitute for insulin. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. Not recommended in patients with pre-existing severe gastrointestinal disease. The concurrent use of Trulicity and basal insulin has not been studied. CONTRAINDICATIONS Do not use in patients with a personal or family history of MTC or in patients with MEN 2. Do not use in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components. WARNINGS AND PRECAUTIONS
Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75
Minnesota Physician February 2016
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and 1.5 mg, respectively, was co-administered with prandial insulin. Severe hypoglycemia occurred in 2.4% and 3.4% of patients when Trulicity 0.75 mg, and 1.5 mg, respectively, was co-administered with prandial insulin. Heart Rate Increase and Tachycardia Related Adverse Reactions: Trulicity 0.75 mg and 1.5 mg resulted in a mean increase in heart rate (HR) of 2-4 beats per minute (bpm). The long-term clinical effects of the increase in HR have not been established. Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to Trulicity. Sinus tachycardia was reported in 3.0%, 2.8%, and 5.6% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Persistence of sinus tachycardia (reported at more than 2 visits) was reported in 0.2%, 0.4%, and 1.6% of patients treated with placebo, Trulicity 0.75 mg and Trulicity 1.5 mg, respectively. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, were reported in 0.7%, 1.3%, and 2.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Immunogenicity : Across four Phase 2 and five Phase 3 clinical studies, 64 (1.6%) Trulicitytreated patients developed anti-drug antibodies (ADAs) to the active ingredient in Trulicity (ie, dulaglutide). Of the 64 dulaglutide-treated patients that developed dulaglutide ADAs, 34 patients (0.9% of the overall population) had dulaglutide-neutralizing antibodies, and 36 patients (0.9% of the overall population) developed antibodies against native GLP-1. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to dulaglutide cannot be directly compared with the incidence of antibodies of other products. Hypersensitivity : Systemic hypersensitivity adverse reactions sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and Phase 3 studies. Injection-site Reactions: In the placebo-controlled studies, injection-site reactions (eg, injection-site rash, erythema) were reported in 0.5% of Trulicity-treated patients and in 0.0% of placebo-treated patients. PR Interval Prolongation and Adverse Reactions of First Degree Atrioventricular (AV) Block: A mean increase from baseline in PR interval of 2-3 milliseconds was observed in Trulicity-treated patients in contrast to a mean decrease of 0.9 millisecond in placebo-treated patients. The adverse reaction of first degree AV block occurred more frequently in patients treated with Trulicity than placebo (0.9%, 1.7%, and 2.3% for placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively). On electrocardiograms, a PR interval increase to at least 220 milliseconds was observed in 0.7%, 2.5%, and 3.2% of patients treated with placebo, Trulicity 0.75 mg, and Trulicity 1.5 mg, respectively. Amylase and Lipase Increase: Patients exposed to Trulicity had mean increases from baseline in lipase and/or pancreatic amylase of 14% to 20%, while placebotreated patients had mean increases of up to 3%. DRUG INTERACTIONS Trulicity slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Trulicity. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Trulicity. In clinical pharmacology studies, Trulicity did not affect the absorption of the tested, orally administered medications to any clinically relevant degree. USE IN SPECIFIC POPULATIONS Pregnancy - Pregnancy Category C: There are no adequate and well-controlled studies of Trulicity in pregnant women. The risk of birth defects, loss, or other adverse outcomes is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes to maintain good metabolic control before conception and throughout pregnancy. Trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In rats and rabbits, dulaglutide administered during the major period of organogenesis produced fetal growth reductions and/or skeletal anomalies and ossification deficits in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. Nursing Mothers: It is not known whether Trulicity is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for clinical adverse reactions from Trulicity in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Trulicity, taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity is not recommended for use in pediatric patients younger than 18 years. Geriatric Use: In the pool of placebo- and active-controlled trials, 620 (18.6%) Trulicity-treated patients were 65 years of age and over and 65 Trulicity-treated patients (1.9%) were 75 years of age and over. No overall differences in safety or efficacy were detected between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment: There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, Trulicity should be used with caution in these patient populations. In a clinical pharmacology study in subjects with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. Renal Impairment: In the four Phase 2 and five Phase 3 randomized clinical studies, at baseline, 50 (1.2%) Trulicity-treated patients had mild renal impairment (eGFR ≥60 but <90 mL/min/1.73 m2), 171 (4.3%) Trulicitytreated patients had moderate renal impairment (eGFR ≥30 but <60 mL/min/1.73 m2) and no Trulicity-treated patients had severe renal impairment (eGFR <30 mL/min/1.73 m2). TrulicityTM (dulaglutide)
Trulicity DG HCP BS 20APR2015 Brief Summary 7 x 9.75
DG HCP BS 20APR2015
No overall differences in safety or effectiveness were observed relative to patients with normal renal function, though conclusions are limited due to small numbers. In a clinical pharmacology study in subjects with renal impairment including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide PK was observed. There is limited clinical experience in patients with severe renal impairment or ESRD. Trulicity should be used with caution, and if these patients experience adverse gastrointestinal side effects, renal function should be closely monitored. Gastroparesis: Dulaglutide slows gastric emptying. Trulicity has not been studied in patients with pre-existing gastroparesis. OVERDOSAGE Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (eg, nausea, vomiting) and nonsevere hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms. PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide • Inform patients that Trulicity causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (eg, a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician. • Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Trulicity promptly, and to contact their physician, if persistent severe abdominal pain occurs. • The risk of hypoglycemia may be increased when Trulicity is used in combination with a medicine that can cause hypoglycemia, such as a sulfonylurea or insulin. Review and reinforce instructions for hypoglycemia management when initiating Trulicity therapy, particularly when concomitantly administered with a sulfonylurea or insulin. • Patients treated with Trulicity should be advised of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with Trulicity of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs. • Inform patients that serious hypersensitivity reactions have been reported during postmarketing use of GLP-1 receptor agonists. If symptoms of hypersensitivity reactions occur, patients must stop taking Trulicity and seek medical advice promptly. • Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant. • Prior to initiation of Trulicity, train patients on proper injection technique to ensure a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inform patients of the potential risks and benefits of Trulicity and of alternative modes of therapy. Inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and advise patients to seek medical advice promptly. • Each weekly dose of Trulicity can be administered at any time of day, with or without food. The day of once-weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days before. If a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, it should be administered as soon as possible. Thereafter, patients can resume their usual once-weekly dosing schedule. If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, the patient should not administer the missed dose and instead resume Trulicity with the next regularly scheduled dose. • Advise patients treated with Trulicity of the potential risk of gastrointestinal side effects. • Instruct patients to read the Medication Guide and the Instructions for Use before starting Trulicity therapy and review them each time the prescription is refilled. • Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. • Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range. HbA1c is especially useful for evaluating long-term glycemic control.
Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Copyright © 2014, 2015, Eli Lilly and Company. All rights reserved. Additional information can be found at www.trulicity.com DG HCP BS 20APR2015 TrulicityTM (dulaglutide)
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PRINTER VERSION 2 OF 2 February 2016 Minnesota Physician
River Falls Area HealthPartners Hospital Launches Announces Plans to New Patient Care Model Build New Como Clinic Allina Health’s River Falls Area Hospital implemented a new hospital medicine program in late December, staffed by hospitalist doctors who only care for hospital patients instead of the primary care physicians who previously cared for them.
HealthPartners has reached an agreement with Luther Seminary to purchase land for a new clinic. The land is across the street from the current HealthPartners Como Clinic, which will move to the new location once it is complete.
“We are excited to see our hospitalist program come to fruition,” said David Miller, president of River Falls Area Hospital. “We believe patients will receive enhanced care, as there will be a dedicated physician onsite to care for them during any hospitalization. We also know this model will free up primary care doctors to spend more time in their clinics seeing patients.”
“Como Clinic represents the roots of our organization, and we are pleased to partner with Luther Seminary and Ecumenon an investment that will continue to serve the community for decades to come,” said Beth Averbeck, MD, senior medical director for primary care at HealthPartners.
The hospital has a professional services agreement with Vibrant Health Family Clinics to staff the hospitalist program and a lead hospitalist will be hired within the year.
The land purchase is the first step in a process that HealthPartners expects to take years. Next they will begin a community engagement and design phase. Groundbreaking is expected to happen in three to four years and construction will take an estimated 18 months. The new clinic will be about the same size and offer the same
services as the current facility, which will remain open until the new location is completed.
Mayo Clinic Using Ultraviolet Light to Reduce HospitalAcquired Infections Mayo Clinic has implemented the use of ultraviolet light devices to help combat clostridium difficile (C-diff) bacteria in patient rooms. “C-diff is extremely distressing for our patients,” said Priya Sampathkumar, MD, chair of Mayo Clinic’s infection control committee. “It can be debilitating, decrease quality of life, and can even result in death.” Mayo Clinic participated in a pilot program from October 2014 through March 2015 as part of a quality improvement project with The Joint Commission Center for Transforming Healthcare, the Centers for Disease Control and Prevention (CDC), and five health care systems. They used the devices to supplement normal
cleaning routines. Results from the pilot showed a 30 percent decrease in C-diff infections in the units cleaned by the ultraviolet light devices compared to those that were not. The results were enough to convince Mayo Clinic to purchase 10 of the ultraviolet light devices in fall 2015 for between $50,000 and $120,000 each. They began using them in early January after training Environmental Services staff to properly use the devices, which are used in rooms after patients have been discharged. Staff set up the devices in the room aimed at surfaces that could have C-diff bacteria, leave the room, and start the device remotely. The device goes through cycles of ultraviolet light bursts in three different parts of the room, adding about 25 minutes of cleaning time per unit. “It’s worth it, because the average increased length of stays for a person with C-diff is three days,” said Sampathkumar. “If we can prevent C-diff infections, we gain that time back.” While cost could prevent Mayo Clinic from purchasing
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Minnesota Physician February 2016
more of the devices in the short-term, there is an optimism about the future of ultraviolet light technology in hospitals. “I suspect as technology improves, prices will come down as it has for other things,” said Sampathkumar. “I do think that at some point in time, this or other similar types of technology will become commonplace.” C-diff is one of the most common hospital-acquired infections. About 500,000 people contract it each year in the U.S. and 15,000 die as a direct result of the infection, according to the Centers for Disease Control and Prevention. The bacteria spores are resistant to many routine hospital disinfectants and can survive in hospital rooms for months. While C-diff infections are on the rise nationally, Mayo Clinic has seen a decline in recent years and has had no deaths related to C-diff in at least two years, according to Sampathkumar.
Fairview Becomes Sole Owner of Health Insurer PreferredOne Fairview Health Services has acquired sole ownership of PreferredOne, effective Jan. 15. Prior to the acquisition, Fairview had 50 percent ownership of PreferredOne, with North Memorial Health Care and PreferredOne Physician Associates each holding 25 percent. Fairview purchased that remaining 50 percent from the two groups. PreferredOne, which employs about 335 people, will now operate as a wholly owned subsidiary of Fairview Health Services. “This new ownership structure strengthens Fairview’s already robust continuum of health care services, deepening capabilities that are critical in today’s health care environment,” says David Murphy, interim CEO of Fairview. “PreferredOne brings expertise in care management, risk management, and population health analytics, and it will be a key strategic asset within our health system as we continue our work to provide high quality care at a lower total cost.” David Crosby, PreferredOne’s president and CEO since August, will remain in his leadership
position and Dan Fromm, Fairview’s chief financial officer, will continue to serve as board chair of PreferredOne. “It’s this type of integration and alignment that will advance our ability to improve health care quality and cost effectiveness,” said Crosby. “PreferredOne will continue to operate with the same exceptional products, provider networks, and services currently offered. Together, we will bring new innovations to market that meet our clients’ needs.” Financial terms of the acquisition were not disclosed.
DHS Adds Telemedicine Requirements to Provider Manual The Minnesota Department of Human Services has updated the Minnesota Health Care Programs provider manual to include requirements to comply with the Minnesota Telemedicine Act. Medical Assistance and MinnesotaCare now cover expanded telemedicine services effective Jan. 1, 2016. The legislation requires that Prepaid Medical Assistance Program plans must cover telemedicine services beginning Jan. 1, 2017. The plans can choose whether or not to cover these services until that date. Minnesota, Indiana, and Nevada joined 24 other states and the District of Columbia in enacting telemedicine parity laws last year. Minnesota’s law says health plans must cover and reimburse for telemedicine services in the same way and at the same cost as in-person services. Medicare coverage is limited to three telehealth services per week per beneficiary. Payment is allowed for real-time interactive audio and video telecommunications between a physician or practitioner and the recipient. Providers must complete the Provider Assurance Payment Statement for Telemedicine, an addendum to the Minnesota Health Care Program Provider Agreement, to self-attest that they meet all the conditions of the policy in order to be reimbursed. Capsules to page 12
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• •Competitive contracts to control Latest in EHRgroup & Webpurchasing Portal technology your costs • Partnering with health plans on new models of care Partnering with with select hospitals, clinics andon employers to • •Partnering health plans new models work on clinical integration and delivery of care Data Warehouse under development. Information is • •Partnering with hospitals, clinics, employers and key to competing and improving quality government entities to work on clinical integration •and Marketing, deliveryrisk management, clinic staff training • Developing strategies to leverage exciting new
• Grant-funded health information exchange (HIE) opportunities: Accountable Care Organizations, development Medical Home, Baskets of Care • Data analytics. Informationphysicians is key to competing and Our independent keep improving quality hometown healthcare where it belongs. • Marketing, risk management, clinic staff training • Developing strategies to leverage Jeff Tucker, CEO new opportunities (firstname.lastname@example.org) including Accountable Care Organization, medical home, episodes of care, bundled COO care, HIE and care Rachael Nyenhuis, coordination(email@example.com)
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Capsules from page 11
Drug Diversions Large Part of Vulnerable Adult Abuse Claims The Minnesota Department of Health (MDH) has found that drugs stolen in health care facilities accounted for about 20 percent of the 141 substantiated allegations of abuse, neglect, or financial exploitation of vulnerable adults between July 2013 and June 2014. According to the Maltreatment of Vulnerable Adults Update, 14 health care workers diverted drugs from 27 vulnerable adults in the one-year period. “Drug diversion and prescription abuse is a growing area of concern nationally and in Minnesota,” said Ed Ehlinger, MD, Minnesota commissioner of health. “We want patients to be aware of the possibility of drug theft, we want workers to know it will not be tolerated, and we want providers to help prevent it by using best medicine
management and tracking policies.” The majority of the thefts, about 70 percent, took place in nursing homes. The others took place in assisted living facilities or in-home care arrangements. Some employees replaced the patient’s narcotics with overthe-counter medications, while others forged documents to steal the medications. MDH found the individual workers, and not the facilities at which they were employed, at fault for the diversions in all of the cases. Most facilities notified authorities and fired the employee who committed the theft, and some took steps to prevent future problems. Some strategies for this included daily narcotic counts, narcotic counts between shifts, training nurses to identify the signs of drug diversion, changing locks on medication storage boxes, and requiring two staff members to sign off on medication flow sheets. This is the first year MDH has tracked incidences of drug theft as part of the report on
Minnesota Physician February 2016
the maltreatment of vulnerable adults. Previously, it included drug diversion cases in the financial exploitation category but didn’t look at them separately.
Wisconsin Joins the Interstate Medical Licensure Compact Wisconsin has enacted a law making it the 12th state to join the Interstate Medical Licensure Compact, which expedites the process of licensing physicians to practice medicine in multiple states. Gov. Scott Walker signed the bill on Dec. 28 at Mayo Clinic Health System–Franciscan Healthcare in Sparta. “It will provide a significant decrease in the time, effort, and expense of having every physician who physically crosses a state line or does medicine virtually go through the licensing process in each state,” said Timothy Johnson, MD, CEO of Mayo Clinic Health System– Franciscan Healthcare.
Last year, Minnesota became the 11th state to enact the legislation, which needed seven states to join in order for it to go into effect in participating states. The other participating states are Alabama, Idaho, Illinois, Iowa, Montana, Nevada, South Dakota, Utah, West Virginia, and Wyoming. The commission has a goal of having all 50 states in the compact. “We are proud that Wisconsin has joined the Interstate Medical Licensure Compact to ensure that all its patients have access to quality health care, while maintaining the highest level of patient protections,” said Kenneth Simons, MD, chairperson of the Wisconsin Medical Examining Board. “By facilitating medical license portability, the Compact will benefit both physicians and patients in Wisconsin and across the nation.” The Interstate Medical Licensure Compact Commission consists of two voting repre sentatives appointed by each member state. The group held its second meeting on Dec. 18.
Medicus Eduardo Colón, MD, board-certified in psychiatry and psychosomatic medicine, has been named the new chief of the Hennepin County Medical Center/Hennepin Health System Department of Psychiatry. Colón has served as vice-chief of the department since 1998. He started at HCMC as in intern in 1979 and completed his residency and fellowship at the Eduardo University of Minnesota, where he is now a proColón, MD fessor in the department of psychiatry. Colón has been an active administrative leader, teacher, researcher, and clinician throughout his career. He earned his medical degree at the University of Puerto Rico School of Medicine. David Hardten, MD, ophthalmologist and director/founding partner of Minnesota Eye Consultants, PA, has been named a recipient of the Allina Health HOPE Award in recognition of excellence in service to patients as measured by the Press Ganey patient experience survey. Hardten earned his medical degree at the University of Kansas School of Medicine, David Hardten, completed a residency in the University of MD Minnesota Department of Ophthalmology, and completed his fellowship training in cornea and external disease at the University of Minnesota and Phillips Eye Institute. He also serves as an attending ophthalmologist at Phillips Eye Institute, an adjunct associate professor of ophthalmology at the University of Minnesota Department of Ophthalmology, and an adjunct professor for the Illinois College of Optometry. Brian Walters, MD, orthopedic surgeon, has joined Glencoe Regional Health Services. He provides surgical care for bones, muscles, ligaments, and joints that have been affected by traumatic injuries, overuse or sports injuries, or chronic conditions, and has special interests in sports medicine, total joint replacement procedures, and minimally invasive surgery Brian Walters, MD for shoulders, elbows, hips, knees, and ankles. Most recently, Walters served as an orthopedic surgeon with Park Nicollet Health Services. He earned his medical degree from the Sackler School of Medicine New York State/ American Program at Tel Aviv University in Israel; completed an orthopedic residency at Lenox Hill Hospital in New York City; and completed a sports medicine fellowship at the American Sports Medicine Institute in Birmingham, Ala. Charles E. Crutchfield III, MD, clinical professor of dermatology at the University of Minnesota Medical School, has been recognized by the Twin Cities Medical Society with the 2015 First a Physician award for making a positive impact on organized medicine. Crutchfield was selected due to his extensive volunteer work and leadership in his field, Charles E. including writing a weekly medical column in Crutchfield III, MD the Minnesota Spokesman-Recorder newspaper and working with his foundation to support Camp Discovery, a summer camp for children with severe skin diseases. He is also an active member of the Minnesota Association of Black Physicians. Crutchfield earned his medical degree at the Mayo Clinic Medical School.
Osmo Vänskä /// Music Director
RODGERS AND HAMMERSTEIN AT THE MOVIES
RODGERS AND HAMMERSTEIN AT THE MOVIES with the Minnesota Orchestra Thu Apr 7 11am Fri Apr 8 8pm / Sun Apr 10 2pm
Sarah Hicks, conductor / Lynne Warfel, host Rediscover the best of Rodgers and Hammerstein’s marvelous musicals on film from South Pacific to Oklahoma!
SYMPHONY IN 60
Thu Apr 14 8pm
Cristian Mă celaru, conductor / Roberto Díaz, viola
Feel the electricity of a classical concert in only 60 minutes! Enjoy the one-hour performance followed by post-concert cocktails onstage with the musicians.
RILLING CONDUCTS A GERMAN REQUIEM Fri Apr 22 & Sat Apr 23 8pm Sun Apr 24 2pm
Helmuth Rilling, conductor / Minnesota Chorale, chorus There is no conductor in the world choral singers are more thrilled to sing for than Helmuth Rilling, who brings a lifetime of study of Brahms’ gorgeous German Requiem.
minnesotaorchestra.org 612.371.5656 / Orchestra Hall PHOTOS R+H: Courtesy of National Symphony Orchestra; Hicks: Josh Kohanek Photography; Macelaru: Sorin Popa; Rilling: Jon Christopher Meyers
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February 2016 Minnesota Physician
Health care economics W hat does the state health economist do? I lead the Health Economics Program, which monitors trends in the Minnesota health care market with a focus on access, costs, health care use, and provider quality. Our team analyzes health care data from a range of sources to provide policymakers and the administration with objective information on a broad set of policy issues. In other words, we monitor state and national trends, collect and analyze data, and synthesize our research findings for a diverse set of audiences.
Stefan Gildemeister Minnesota Department of Health Mr. Gildemeister is the state health economist and director of the Health Economics Program at the Minnesota Department of Health. In this role, he advises policy makers and the commissioner of the Health Department on a broad set of health policy and reform issues. He also directs applied policy analysis and health services research covering topics, such as health care costs, access to health care, provider performance, and health care market trends. Mr. Gildemeister holds degrees in economics and economics/ business administration from the New School for Social Research, New York, and the University of Bremen, Germany. Over the years, he has consulted on a variety of health policy issues for organizations and academic institutions in Germany and the U.S.
W hat can you tell us about the Minnesota All Payer Claims Database (MN APCD)? Minnesota invested early on in the development of a dataset that integrates data on administrative health care transactions from public and private payers. Because of the richness of diagnostic and treatment information, as well as data on payments for health care services, it can serve to inform several important system-level policy decisions. MDH’s current authority permits us to do this system-level work through June 2016 unless the legislature acts to extend that authority. W hat kind of questions do you help answer? The topics we get to work on can be very broad, ranging from big picture questions to highly technical dives into specific aspects of health care. For example, we study how many people in Minnesota are uninsured and we estimate the state’s health care spending. But we also study questions such as whether the current capacity of radiation therapy facilities in Minnesota is sufficient to meet future needs or to what extent patients overuse emergency rooms or experience potentially avoidable hospital readmissions.
How do you know that the work you are doing is successful? There are different ways to know whether our work has made a difference. Most important is how useful the analysis is for policymakers and their deliberations, and we get a sense for this based on Legislative requests for testimony or reports. We also consider general media coverage an indication of relevance, or whether the community uses our analysis and research findings. Some of our most rewarding work involves providing evidence that fills knowledge gaps and promotes change on the ground. What are some areas where you see room for cost savings in health care delivery? Reducing health care spending is complex, as the last 20 years of rising costs have shown. Minnesota and the U.S. are testing some promising models that could slow the rate of spending growth—I’m less optimistic that we can actually reduce levels of spending. Many of these efforts focus on the idea of delivering the right care at the right place at the right time, particularly for complex patients. The majority of health care spending is concentrated among patients with chronic conditions and other complex health needs, so there is an opportunity for bending the cost curve by improving the coordination of their care or delaying the onset of disease. Since prices, including for prescription drugs, are important drivers of spending growth, we need to look for payment models that support effective health care use and constrain irrational price inflation.
What’s an issue that you think is going to have a greater and greater impact on the cost of health care in Minnesota, which isn’t yet getting a lot of attention? W hat are some of the projects that you are Largely in response to the rising cost of health currently working on? care services, we spend a lot of time discussing We just released two reports in which we identify insurance product design for the entire population, the burden of chronic disease in Minnesota and pro- generally looking for ways to constrain premium vide an accounting of trends in how much we spend growth through cost sharing mechanisms. on health care. Some of this research benefited from A promising alternative area of focus are people the availability of the MN APCD, a rich data source with the highest health care needs and spending. we’re just beginning to use more effectively. Other high-priority studies include: 1) Collaborating with If 10 percent of the population is responsible for the University of Minnesota to understand changes about 67 percent of costs, why do we spend so much time on the 90 percent who account for a in insurance coverage and access in Minnesota to produce new rates of uninsurance. 2) Studying op- small share of total spending? By managing care portunities available to state policymakers to create for the most complex patients better, we might not only be able to produce better experiences for these a balanced playing field among health insurance providers in the individual and small group market patients, we might also be able to reduce average per-person spending so successfully that actual in Minnesota. 3) Reporting, for the first time, on premiums could stay flat instead of rising. health care use and quality of care for children in Minnesota. 4) Describing how quality measurement It sounds like the MN APCD can help us can be affected by patient demographic characterunderstand more about the cost of care. istics. 5) Studying new information on drug spendHow does this benefit the consumer? ing to help assess the sustainability of prescription Patients didn’t used to spend much time wonderdrug spending. ing about the cost of care. Now, as patients we ask whether tests were repeated, whether information
Minnesota Physician February 2016
is available among providers who take care of us, or whether a brand-name drug is necessary in place of an equivalent generic product. As patients have become responsible for a greater share of health care spending, including through higher deductible plans, understanding the cost of care is a pocketbook issue. In a more global sense, it is important for everyone to understand the vast resources that are being dedicated to health care, because it affects what as society we can spend on other policy priorities. Though these costs are often masked because insurers, the government, and employers foot parts of the bill, they are real and they affect everyone because costs are spread across an insurance pool and we support payments for people on public health insurance, like Medicare for the elderly, through tax payments. How has the ACA affected Minnesota’s health care market? I think we still have an incomplete understanding of the full effect of the ACA. We do know insured rates have risen bringing coverage and peace of mind to many, all apparently without a decline in the role that employers play offering coverage. We’ve
also seen that hospital-based uncompensated care has declined as coverage rates increased. Again, this is a trend that was driven by ACA implementation.
Patients didn’t used to spend much time wondering about the cost of care.
We expect that our work over the next few months will contribute to our understanding of how access to care has changed, in part because of the ACA. We are also working on documenting trends in the non-group insurance market, where we expected the most change because of the ACA through regulatory change, some standardization in benefit design, and availability of financial subsidies to purchasing coverage.
and they are change agents with a commitment to science. For us it would be helpful to know what kind of analysis physicians lack in order to foster system change. Much of our analysis identifies opportunities for change at a high level. We need help determining in which direction we should “dig deeper.” For instance, now that we have estimates on potentially preventable emergency department visits, admissions and readmissions, what questions should we be asking to understand the factors that contribute to these rates and foster needed change, whether through organizational reform, change in financing, or changes in access. Another question for physicians is, what are the statistical population health or delivery system benchmarks they need in order to assess the progress of their patients.
In our work, we try to make our takeaways meaningful for a broad range of audiences, using brief policy papers, preparing presentation slides, providing summary data tables, or producing more in-depth re What information would you like from ports. We are always interested in knowing physicians to help you use the data whether this information reaches physicians you collect in the most efficient way? or if they prefer other means of delivering Physicians are really key because they are research summaries. on the front lines of health care delivery
ME E T I NG OF THE
MINDS DE M E NT IA CONFE R E N C E 2016
St. Paul RiverCentre
engage.connect.learn. KEYNOTE SPEAKERS Mary Mittelman, D.P. H.
Research Professor of Psychiatry and Rehabilitative Medicine, NYU School of Medicine
Donald Warne, M.D., MPH
Director of the Master of Public Health Program, North Dakota State University; Senior Policy Advisor, Great Plains Tribal Chairmen’s Health Board
Learn more and register at
alz.org/mnnd #ALZminds February 2016 Minnesota Physician
Chronic disease spending in Minnesota from cover
more chronic diseases such as diabetes, asthma, or congestive heart failure spent on average $12,800 a year on health care. That is nearly eight times the $1,600 average spending by an insured resident without a chronic condition. For many families, this chronic disease spending makes it difficult to find the money to afford necessities such as food, housing, and education. Living with multiple chronic conditions adds an average of $4,000 to $6,000 in health care expenses per condition (see Figure 1). With costs that large, patients with at least one chronic condition (about 35.4 percent of Minnesotans) accounted for the vast majority (83.1 percent) of the state’s health care spending in 2012. The report found that patients’ costs vary significantly by geography within Minnesota, even when treating the same conditions. More work must be
done to determine what causes these cost differences, but they occurred even when our researchers controlled for age and other demographic factors correlated with chronic disease. The widest differences occurred among patients with renal failure. For example, the average medical spending by patients with chronic renal failure who lived in Houston County was about $24,690 compared to the average spending for residents with the conditions in Stevens County of $50,760 per patient. As part of that effort, the report provides cost and prevalence estimates for 10 diseases (see Table 1). Clarifying the cost of these diseases and showing some of the interplay between risk factors such as high blood pressure and high cholesterol can help disease advocacy groups make their case for the need for more prevention activities, resources, and research. For example, care for high blood pressure (and co-occurring
conditions), which affects more than 900,000 insured Minnesotans, cost nearly $13.5 billion and accounted for almost half of all medical spending for the insured in 2012. The total cost numbers, the disease-specific breakdowns, and county-level data make this an important report for Minnesota because it sets a baseline for chronic disease spending. This report was only possible through special access to the Minnesota All Payer Claims Database. The Minnesota Legislature granted temporary approval for MDH to use MN APCD data to establish this baseline and better understand the interplay of chronic disease and our health care system. This legislative approval expires this year and can only be renewed by legislative action.
Minnesota Physician February 2016
In recent decades, it has become evident that this focus and treatment alone will not create health and will be difficult to sustainably finance in the future. While it may repair some injuries, relieve some discomfort, cure some diseases, and prolong some lives, treatment alone will not improve our overall health. The reasons are that our lifestyles and environment are creating unhealthy conditions that are overwhelming the curative and rehabilitative capacity of our health care system. In the long run, I believe the best approach to turning the curve on chronic disease is to adopt what I call the Triple Aim of Health Equity.
Patients’ costs vary significantly by geography within Minnesota.
How we got here For most of history, infectious diseases and injuries were the leading causes of death and disease. Many of these diseases were beyond the ability of an individual to control. Community-wide efforts were essential to ensure clean air and water, effective sanitation, safe food, safe worksites, and immunizations necessary to reduce these threats and improve the health of community members. These community efforts in combination with clinical care dramatically reduced deaths from acute diseases and injuries. However, this opened the door for chronic diseases like heart disease, cancer, and diabetes to take their place. Surprisingly, the approach used so successfully for acute diseases has not been embraced to address modern-day killers. Instead, the focus has been on
clinical care and individual education about personal behaviors.
The “Triple Aim of Health Equity” The health care Triple Aim, well known among clinicians, is to improve quality and patient satisfaction while also reducing costs. This chronic disease report provides direction in those arenas and confirms that we must continue to pursue health care reform efforts that move the system toward increased care coordination, disease management, prevention of hospital readmissions, “hot spot” care for patients with multiple chronic conditions, and better use of health information technology. Minnesota has been a leader in all of these areas. The federal government awarded Minnesota a $43 million State Innovation Model Grant to support the Minnesota Accountable Health Model, which includes elements such as health care homes, integrated
health partnerships, e-health initiatives, and workforce expansions of community paramedics, dental therapists, and community health workers.
• Strengthen the capacity of communities to create their own healthy future. The value underlying these three components is community connectedness—the social capital and social cohesion that is essential for individual and community health. The Triple Aim
These efforts are important for allowing us to deliver the best quality care possible to those who are already ill. But we must move beyond the focus on treating illness and look to prevent it from taking hold in the first place. We must also realize that in a world with limited financial resources, we cannot continue to absorb fast-rising health care costs. Part of the answer is to realize that what is good for our health care system may not be good for communities or health equity. Another part of the answer is to recognize that we can sometimes fall into a trap of viewing all health through the health care lens and reinforcing the narrative that health is solely about health care. As a corrective to that view, which I believe underemphasizes key drivers of health such as social determinants, and thus in some manner contributed to the rise of chronic disease, I offer an alternative triple aim for consideration—the Triple Aim of Health Equity:
High blood pressure (and co-occurring conditions) … affects more than 900,000 insured Minnesotans.
of Health Equity is built on a community health model, not an efficiency model. It recognizes that health is created in communities by the social, economic, and environmental conditions in which people live, work, and play. It acknowledges that every sector of the community (including health care) impacts the community’s health. Most importantly, it recognizes the need for communities to possess the power to address the conditions that affect their health. To build healthy communities, the health care system should not be in charge of health nor should the public health system. The community needs to be in charge of health.
• Expand our understanding about what creates health; • Implement a Health in All Policies approach with health equity as the goal; and
Figure 1. Minnesota residents by average annual health
care spending and number of chronic conditions, 2012. 80%
Percent of insured Minnesota residents
$9,775 $5,684 $1,560
3% 2% 1% 1% 1%
Number of chronic conditions
Source: MDH/Health Economics Program analysis of data from the MN APCD
Per-person annual health care spending
Health care and public health are crucial to creating healthy communities but are only two of the multiple partners who need to be at the program and policy tables where decisions are made about how to invest in health for current community members and for generations to come.
Lend your voice to chronic disease prevention Physicians are natural public health partners when it comes to fighting chronic disease because they clearly see how the factors influencing chronic disease—income, education, housing, personal behaviors—occur outside the clinic and beyond their control. I know physicians are fatigued by the constant drumbeat that presumes doctor responsibility for the elimination of costly chronic diseases. This unfair burden on doctors is yet another negative effect of the “health care as panacea” narrative. Public health
knows that blaming doctors for chronic disease or counting on them to eliminate it themselves is the wrong approach. The problem of chronic disease can only be solved by the whole community. Minnesota is implementing some strategies that give us a good start in this area, but these efforts will require further scaling up to address the expected increase in chronic disease in the state. Efforts such as the Statewide Health Improvement Program (SHIP), focused on implementing policy, system, and environmental changes to support healthy living in communities across the state, have already shown results in the areas of promoting healthy eating, reducing smoking, and increasing physical activity. In addition, the 15 Accountable Communities for Health (ACH) established under Minnesota’s federal State Innovation Model (SIM) grant are showing early promise by developing local solutions to high rates of chronic conditions. The Minnesota Department of Health and its partners have also developed a strategic framework for public health action, summarized in a plan Chronic disease spending in Minnesota to page 41
Table 1. Average health care spending for patients with specific chronic diseases without and with comorbidities, 2012. Condition
Avg. Annual Spending
Avg. Annual Spending
High blood pressure
Congestive heart failure
Ischemic heart disease
Chronic kidney failure
Source: MDH/Health Economics Program analysis of data from the MN APCD
Residents with Diagnosed Comorbidities
Residents without Diagnosed Comorbidities
February 2016 Minnesota Physician
Change management from cover
opportunities for American health care. Most recently the Affordable Care Act has necessitated change for the health systems, individual providers, and our patients. According to Rashid Al-Abri, MD, an academic in Oman, the only sustainable competitive advantage we have today is the ability to change, adapt, and evolve—and to do it better than the competition. Therefore, change management must be embraced by leaders and health systems and given the appropriate amount of valuable attention it deserves. Change can come in almost any form, ranging from barely noticeable to transformative. Some common changes in health care involve reorganization within departments, revised processes, integration between systems, approval of research protocols, adoption of new technology, and improvements to a facility. Changes can occur through an elective process, such as a clinic choosing
to expand its footprint or services. Or, change can come about because of a mandate such as the required adoption of electronic health records. Understanding the reason for change and the process is an important first step to successfully managing it and determining an implementation plan. While complicated descriptions of the change implementation process exist, a simplified version of the implementation process can be described in five simple steps: assessment, preparation, plan, implementation, and evaluation. However, the way in which leaders follow these steps through implementation is critical. Promoting change can be both demanding and fatiguing. People do not resist change in general, they resist change that they either don’t understand or don’t feel is beneficial. What may seem like a minor or insignificant change to one person, may cause major changes for another. Employees
Minnesota Physician February 2016
want to understand the reason for change and how it will affect them. If you’re able to effectively communicate what change means, your chances of successfully managing change increases significantly. There is an adage that says, “Sell, don’t tell,” which challenges leaders to help employees understand the reasons for change and why it is necessary.
Change can come in almost any form. A metaphor that aptly describes the dynamics and importance of change is the difference between rivers (change) and puddles (stagnation). According to Ann Rogerson, a senior lecturer in the School of Business Management with the University of Wollongong in New Zealand, a flowing river represents continuous yet incremental development and refinement of a moving force. Rivers are constantly renewed with fresh water, are influenced by internal and external forces, and can adapt as necessary to the environment, always moving toward an end point. Rivers can be redirected, harnessed, channeled, and reused. In contrast, a puddle contains stagnant water that is never renewed and has no ultimate destination without external help. Puddles are limited by boundaries, cannot effectively adapt, and will eventually evaporate. Rivers can be mapped and understood whereas puddles are directionless and largely without purpose. Using the metaphor of rivers and puddles to characterize the depth and dynamics of change, can help illustrate the complexity of change to those who are directly involved in implementation, or those who are affected on the periphery. However an organization chooses to define and understand change, there are a handful of common and effective strategies that leaders can practice to optimize their success
with change management. Change does not happen in isolation, but rather it impacts the entire organization and systems around it. The following strategies should be applied throughout the change process, and can greatly improve one’s ability to successfully manage change. Establishing a clear plan When faced with the necessity for change in health care, be sure to set a clear vision and strategy for moving forward and be certain how you want to implement it. It is very important to communicate the change clearly so your employees understand why it is necessary and how it will affect them. During implementation you should set up milestones, encourage regular progress reports, and reward achievements. To help you keep your plan on track, there are many project management products on the market such as Microsoft Project, Kanbanery, Asana, and more. If something less formal is preferred for tracking, you can use existing tools such as spreadsheets, shared drives (on a server or cloud-based Dropbox), and flowcharts. The selection of project management tools should depend on the team members and leadership preferences and work style. Understanding the people and the culture Every river flows differently and every hospital, clinic, and provider is also different. While we are not terminally unique, differences exist and it is important to accommodate those nuances. Autocratic or authoritarian leadership styles are generally ineffective and subject to failure, but this is especially true during times of change. While it may seem easy to bark orders and demand outcomes, that is the fool’s way of motivating stakeholders during times of stress and change. A good leader must not only understand the people and the company’s culture, but also show they understand it through their actions. This builds trust. Establishing structure and a consistent style of communication that is in
tune with corporate culture will ensure progress. A leader should display confidence in their plan and decision-making, but also show humility and a willingness to accept input. Creating opportunities for employee feedback makes them feel valued and part of the process, creating champions for change. Concise and timely communication According to George Bernard Shaw, “The single biggest problem in communication is the illusion that it has taken place.” Change management requires thoughtful planning, quick thinking, and agile maneuvering. Often, the high stakes, stress, and excitement of change in health care can hinder communication and individuals may quickly find themselves uninformed. Surveys conducted with hospital employees regarding change management show that communication is the most important factor in the success of managing change and building trust. It is up to leaders to find the most effective way to communicate concise and timely information surrounding changes so nobody is inadvertently left out of the loop. You may need to adapt your method of communication to individual people so it is important to understand how they best absorb information. This may also mean using a variety of strategies to communicate with employees. Providing concise and timely information is one of the best ways to create trust and confidence during times of change. Leaders should communicate consistently, and not just when there is news to share. This can be done through routine newsletters, regular meetings, individual check-ins, intranet announcements, and in-services. Some employees may prefer in-person communication, while some may be content with email. Some may understand graphical information best, whereas some may prefer text. Effective communication may be one of the most important aspects of change management, yet it is often taken for granted
or ignored entirely. As a leader, you should show progress on tasks and incremental achievements that build confidence surrounding change.
influence and inspire the people involved. Even after careful assessment and clear planning, the need for an agile response and adaptive management
“The single biggest problem in communication is the illusion that it has taken place.” George Bernard Shaw Anticipating needs The best leaders are the ones who anticipate needs rather than react to them. While this is often easier said than done, your ability to plan and avoid mistakes will prove incredibly valuable while managing change. During the assessment process a leader should consider the butterfly effect of their actions. A change, no matter what size, may in fact inadvertently impact an individual, department, or process elsewhere in the organization unbeknownst to the original catalyst. It is important to strategize about these effects and as a result anticipate the needs of those directly affected along with those on the periphery. Not anticipating needs can be disastrous and lead to a lack of confidence among employees. A lack of confidence in leadership can undermine the bestlaid plans and set off a lack of employee commitment. Adaptive management Leaders who can adapt and thrive in challenging environments by applying a heuristic problem-solving process will be more successful than those who are rigid and unwilling to think creatively. The framework of adaptive leadership compares the differences between technical and adaptive challenges. This framework describes a technical challenge as something that can be solved with a single fix or solution—such as changing a tire on a car when you get a flat, or upgrading a computer processor to improve speed. An adaptive challenge does not have a defined solution, but requires creative problem solving and the application of a tailored approach to
will be critical for a successful implementation. Chaos theory states that behavior in dynamic systems is highly sensitive to initial conditions, and outcomes are almost impossible to replicate. Whether the change warranted is elective or mandated, each situation is unique and subtle nuances will exist. Whether change involves technology, finances, or individuals, a good leader will deploy adaptive management techniques to closely monitor and respond to the change process to insure optimal outcomes.
Conclusion As foreshadowed by Heraclitus 2,500 years ago, health care in the United States will constantly change and undoubtedly improve to create more robust and comprehensive ways to improve population health, reduce the cost of care, and improve patient satisfaction. It is up to health care administrators and clinician leaders to find ways to plan for and manage change in the most efficient and effective ways possible. This involves adapting to external forces within health care, whether these forces are political, social, or financial, as well as recognizing and embracing opportunities to improve health care through collaboration and innovation. Todd Archbold, LSW, MBA, is a
licensed social worker, the chief operating officer at PrairieCare, and the practice manager of PrairieCare Medical Group. He serves as the executive director of the Minnesota Psychiatric Consultation Service.
Your Link to Mental Health Resources
February 2016 Minnesota Physician
Special Focus: Allied Providers
o meet the demands for effective and efficient delivery of care, giving the consumer the opportunity to access a physical therapist at the entry point to the health care system not only makes sense, but it may be an essential provider strategy to meet the Triple Aim—measurable outcomes and a better patient experience at a lower cost. Today’s doctors of physical therapy, trained in the primary care model, can diagnose and treat conditions of the musculoskeletal system. Alongside other medical, nursing, and behavioral health specialist providers, the physical therapist is equipped to lead or provide team-based care to manage acute and chronic conditions affecting young and old alike. Physical therapists are movement experts, and all musculoskeletal conditions have movement at the heart of the problem or at least a component of the problem. In 2005, Childs, et al. concluded
Direct access to physical therapy Improving patient outcomes By Craig Johnson, PT, MBA
that experienced physical therapists had equal to or higher knowledge than any other provider (commonly treating such conditions) in managing musculoskeletal conditions, including specialty physicians. Access to physical therapy One of the largest health systems, Kaiser Permanente, and the U.S. Army Medical Department allows patients with musculoskeletal conditions to see a physical therapist without a referral. Both systems use an algorithm that guides the patient to the most appropriate provider that may include
Minnesota Physician February 2016
a physical therapist, medical doctor, nurse practitioner, behavioral medicine specialist, clinical educator, and in some cases pharmacist. Kaiser determined that approximately 20 to 25 percent of patients coming to primary care had musculoskeletal conditions that could be effectively managed by a physical therapist, allowing physicians and nurses to focus on the management of other conditions. The Army found that the primary care provider and physical therapist often operated in isolation from one another. As a result, they developed a team-based approach that builds relationships between providers, where they understand what each has to offer the patient. Both Kaiser and the Army focus on ensuring that the patient’s overall health needs are addressed, which for the physical therapist means including primary and secondary prevention goals related to hypertension, hyperlipidemia, diabetes, and heart conditions. Initial outcomes from the Army show that the physical therapist was able to take a more holistic approach to patient management. Therapists who participated in the team approach had higher job satisfaction compared to non-participating therapists. They were able to reduce the backlog of patients waiting to access health care. These interdependent care teams at Kaiser and the Army developed electronic health record (EHR) tools to ensure that medical information is accessible so a patient’s case can be better managed. For over 30 years, Minnesotans have accessed physical
therapy services without a referral. Independent practices were early adopters of “direct access,” while hospitals were slower to adopt. Patient demand for direct access has been increasing as consumers look for value in their personal health care spending. Insurance benefit and coverage of non-referred physical therapy services is variable and increasing as payers look for that same value. Physical therapy is being sidestepped In 2013, Price Waterhouse Cooper reported that of the $3 trillion spent on health care in the U.S. in 2012, 50 percent of the care was either duplicative or unnecessary. Based on 2013 data, Optum reported that 17 percent of patient conditions are musculoskeletal, and of those, 51 percent are related to low back pain. Significant spending occurs in musculoskeletal conditions and when entry to the health care system is fragmented it often does not involve physical therapy. Optum Health has data on over 3 million of its members with low back pain, and it showed that approximately 7 percent of its members never saw a physical therapist. Optum found in their claims analysis that more than
Fragmented care is expensive and in many cases, ineffective.
20 different providers were entry points for patients with low back pain. Of those providers, the lowest total cost of care was attributed to two providers: physical therapists and chiropractors. Using a large national claims database, a study in 2008 by Fritz, et al. showed that the majority of care for low back pain does not involve physical therapy (PT). In the research designed to measure the effect of early access to physical therapy compared to delayed access, Fritz found that only 7 percent
of patients with low back pain received physical therapy. Fragmented care is expensive and in many cases, ineffective. With regards to the management of musculoskeletal conditions, these patients not receiving physical therapy are inconvenienced and end up paying for multiple evaluations, duplicate tests, advanced imaging, invasive procedures, or surgery. Many end up with chronic pain and/or opioid dependency. The reality is that we still have a fragmented health care delivery system even in the progressive state of Minnesota. Patients with musculoskeletal conditions should access health care via the provider that is best trained to effectively and efficiently manage their condition. Differences in cost In a one-year retrospective study in 2015 by Fritz et al., she studied the effect that the initial provider had on patients with a new episode of low back pain. Fritz looked at the patient clinical pathway for the entire episode from the time the patient entered care via primary care, physiatrist, chiropractor, and physical therapist. Her research found that primary care episodes had double the incidence of imaging, injections, emergency department visits, and surgery compared to chiropractic and physical therapy. Physiatrists had an even higher incidence of these procedures than primary care. This is not to say that all imaging, injections, or surgery are unnecessary, but for most patients accessing outpatient services for low back pain means managing their care without expensive testing or surgery. The Fritz study in 2008 saw when there was early access to physical therapy (<14 days post referral—$3,150), the total cost was 45 percent less than episodes that had delayed access to PT (>14 days post referral—$5,885). This study was based on total cost and included all providers. The research also showed that after physical therapy was completed, patients were subjected to fewer expensive tests, were
secondary prevention, and the role they can play in the management of many conditions. By taking a more responsible, holistic approach the physical therapist will effectively act as the entry point to the health care team that will address the patient’s health needs. The model in which the health care consumer accesses physical therapy as an entry point into the health care system presents an opportunity to improve the health care delivery system. This model is aligned with the Triple Aim; measurable outcomes, improved patient experience, and lower cost of care; which today is the standard by which effective and efficient health care is managed.
fragmented, research and reallife examples show that the patient, provider, and payer/
not given opioids, and had fewer doctor’s visits, injections, and surgery.
The majority of care for low back pain does not involve physical therapy.
A pilot study managed by Therapy Partners, for a network of physical therapy providers in a northeastern state, demonstrated that they could effectively manage non-operative shoulder conditions, and reduce total cost of care by 20 percent over a 12-month period. The provider network used a functional outcome tool with a large risk-adjusted national database to better manage patient care. The pilot demonstrated the important role of the physical therapist in delivering on the Triple Aim. Other conditions benefit from physical therapy In addition to musculoskeletal conditions, physical therapists involved in team-based care have been tasked with preventing and managing medical conditions such as diabetes, arthritis, falls risk, and obesity. The expanded role of physical therapists is becoming more commonplace. One such example is in the management of prediabetes. Medical monitoring of A1C and medication, along with active exercise guided by a physical therapist, has shown reduction in A1C test results, preventing the condition from advancing. Another example involves reducing falls in older people through early screening and collaboration with community-based services that deliver group exercise programs. As experts in movement and neuromuscular control, physical therapists set up programs that focus on elements of balance and neuromuscular training to decrease the likelihood of falls in older individuals. What the research shows While the entry point for musculoskeletal care is still
purchaser all benefit from early and direct access to physical therapist services. As the studies at Kaiser Permanente and the Army Medical Department show, collaborative relationships among providers, with an understanding of what each has to offer the patient, is the most effective. Based on that understanding, the health care team needs to find a way to get the patient to the most appropriate provider. Communication between providers, and between patient and provider, can support the collaborative effort. Physical therapists understand the concept of primary and
Craig Johnson, PT, MBA, is a partner
and the director of Clinical Integration at Therapy Partners (TPI) where he leads therapists in the optimal use of outcome tools and improvement in care management.
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Specialists in Nonsurgical Treatment of Neck and Back Pain www.PDRclinics.com February 2016 Minnesota Physician
Special Focus: allied Providers
uthority to practice as an advanced practice registered nurse (APRN) in Minnesota requires a Minnesota APRN license. Additionally, an APRN must have current certification by a national nurse certification organization acceptable to the board as a certified clinical nurse specialist (CNS), certified nurse practitioner (CNP), certified registered nurse anesthetist (CRNA), or certified nurse midwife (CNM). In 2014, the Legislature amended the Nurse Practice Act by removing the requirement for collaborative management and a written prescribing agreement for all four roles of APRNs. However, this amendment did not change that APRNs are accountable to patients for the quality of APRN care, to recognize the limits of their knowledge and experience, to plan for management of situations or patients when they are beyond the APRNâ&#x20AC;&#x2122;s expertise, and to consult or collaborate with other health care
Advanced practice nursing in Minnesota An update By Julie Sabo, PhD(c), APRN, CNS providers as warranted by the needs of the patient. Background and national trends for APRN regulation In 2010, the Institute of Medicine (IOM) published the report, The Future of Nursing, Leading Change, Advancing Health. One of the four recommendations stated in the report is that nurses should practice to the full extent of their education and training. Licensing and practice authority for APRNs vary considerably across states, which leads to inconsistencies in entry into practice requirements for APRNs across the
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Minnesota Physician February 2016
United States, and ultimately affects patient care. Two years prior to the 2010 IOM Future of Nursing report, the APRN Consensus Model was published by the APRN Consensus Work Group and the National Council of State Boards of Nursing. The model was developed by over 40 professional nursing associations, APRN faculty members, and the National Council of State Boards of Nursing. The model defines a uniform model of entry into practice requirements and standards for regulation. The model language requires APRN licensure for authority to practice, graduate level education and clinical training standards, national certification in one of the four roles and six populations, and removes barriers to practice such as collaborative practice and written agreements with physicians. Implementation of this APRN Model reduces variation in regulatory standards for APRNs across the country and the removal of practice barriers increases access to care for consumers. As of June 2014, 12 states have adopted the Consensus Model language into law, including Minnesota. In the past year, Maryland, Nebraska, Delaware, Iowa, and Oregon also passed legislation that aligns their APRN practice laws with the Consensus Model. There are at least four other states with pending or proposed legislation for the upcoming legislative sessions. Clearly, APRN practice and regulation standards across the nation are changing and becoming more consistent. The National Council of State Boards of Nursing has more information regarding state and national activity for the Consensus Model and regulation of
APRNs on its website at https:// www.ncsbn.org/738.htm. The history of APRN practice in Minnesota From 1999 to Jan. 1, 2015, authority to practice as an APRN required a current Minnesota RN license and current APRN certification from a national nursing organization that was recognized by the Board. The APRN was required to submit a copy of the certification to the Board and this information was placed on the Minnesota APRN Registry. Specific privileges granted to APRNs have changed considerably over the years. In 1983, the definitions of CNMs and CRNAs were added to the health insurance laws that allowed for third-party reimbursement for services. Prescribing authority was granted to CNMs in 1988, to CNPs in 1990, and to psychiatric-mental health CNSs in 1994. In 1999, prescribing authority for all CNSs was included in the law if specific educational preparation with a supervised practice component was completed and submitted to the Minnesota Board of Nursing. The changes passed into law in May of 2014 and effective Jan. 1, 2015, fully implemented the APRN Consensus Model.
There are 6,828 APRNs licensed in Minnesota. The Board of Nursing has appointed an APRN Advisory Council in compliance with the law. The Council is made up of four APRNs; one from each role, two physicians, and one public member. The purpose of the Council is to review trends of APRN practice and emerging practices that may overlap with specialty medical practices and to provide recommendations to the Board. The Council is required to meet at least once every six months and met three times in 2015.
Scope and standards of APRNs An APRN license is granted first as an APRN, then within a specific role and population. The six recognized populations in the law are: 1. Family and individual across the lifespan 2. Adult-gerontology 3. Neonatal
It is important to note that all APRNs are required to practice within the role and population in which the individual is licensed and certified. The scope of an APRN by law includes, but is not limited to, performing acts of advanced assessment, diagnosing, prescribing (all medications including scheduled II-V controlled substances), and
magnetic resonance imaging scans, positron emission tomography scans, nuclear scans, and mammography. Further detailed scope and standards of an APRN are defined by the national professional nursing organizations specific to the practice as a CNS, CNM, CNP, or CRNA in the specific population focus.
4. Pediatrics 5. Women’s and genderrelated health
A separate APRN license is required for each role, although the CNS or CNP may be certified in more than one population. The population designated for CRNAs is family and individuals across the lifespan as they are educated and trained to care for individuals of all ages. Certified Nurse Midwives population is women’s and gender-related health.
ordering. The practice includes function as a primary care provider, direct care provider, case manager, consultant, educator, and researcher. APRNs may order, perform, supervise, and interpret diagnostic studies, excluding interpreting computed tomography scans,
3. Have completed a graduate level APRN program accredited by a nursing or nursing-related accrediting body recognized by the U.S. Secretary of Education or the Council for Higher Education Accreditation. The education must be in one of the four recognized APRN roles and for at least one of the six populations, 4. Hold current national nursing certification that is recognized by the board in one of the four roles, and at least one of the six populations and that is aligned with the education preparation,
“Nurses should practice to the full extent of their education and training.” Institute of Medicine
6. Psychiatric and mental health
license as an RN in any state or territory of the U.S.,
An individual eligible for licensure as an APRN must:
5. Report any criminal conviction, nolo contendere pleas, Alford pleas, or other plea arrangement in lieu of conviction, and
1. Hold a current Minnesota RN license,
6. Must not have committed any acts or omissions that
Requirements for APRN licensure
2. Not have an encumbered
Advanced practice nursing in Minnesota to page 40
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Special Focus: Allied Providers
hildhood speech and language disorders are common, but may be overlooked and underdiagnosed. Although speech sound errors (e.g., a distorted “s”) and stuttering may be easily heard, language impairments and disorders may appear “hidden” or be confounded by other behavioral or developmental issues in children. If not addressed early, challenges with language can lead to long-term impacts on a child’s education and behavior. In order to best understand language, it is important to conceptualize the common domains of language and put them in the context of development. 1. Form: Grammar or speech sounds (consonants and vowels). 2. Content: Meaning (including vocabulary and prefixes/ suffixes). 3. Function: Appropriate use for the setting—including the
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Minnesota Physician February 2016
of a language disorder or other related developmental issues. Early markers Hearing: Infants are born with a fully formed cochlea and a perceptual and neurological system that makes them truly “international” in their approach to language learning. Early in development, infants will startle to sound and will be soothed by the sound of their mother’s voice. By 4 to 6 months, baby has enough control to localize to sound and visually search for sounds that are of interest in her/his environment. The development of Early Hearing Detection and Intervention programs make screening an infant’s hearing part of the typical newborn hospital experience. However, it is important to remember that hearing may fluctuate or change over time. Therefore, passing a screening at birth may not always be a guarantee of adequate sensitivity for speech and language development, because hearing can change or fluctuate due to a myriad of factors (e.g., otitis media, genetic factors, acquired conditions). Babbling: Early on, babbling may provide critical information to the practitioner and parents. Babies are “born to babble” and will do so around 4 to 6 months of age. Early babbling is repetitive in nature (“ba-ba-ba”) and may not necessarily have communicative intent. This babbling grows into a type of “nonsense speech,” which becomes more like adult speech in its tone and variety of sounds, as baby progresses through the first year. It is important to consider
that babies are “born to babble” and will incorporate the early forms of babbling early on in their development, regardless of hearing status. However, if baby stops babbling, or does not advance into a more sophisticated pattern of babbling during the first year, this may be the first clue that either a hearing or other developmental language problem may exist. Speech sound development: This will develop over time. A general rule is that sounds made more toward the front of the mouth (/p/, /m/, and /b/) are typically acquired early on. Those that are developed later include sounds such as /s/ and /r/, which may not be fully mastered until 7 or 8 years of age. It is important to remember that speech sound production will not be accurate early in life, in fact, this is often part of what makes the speech of the toddler endearing to their parents and families. However, if the young child has difficulty producing many speech sounds, their speech may be difficult for their caregivers to understand. This can cause frustration for the child—and those around them. Children should be largely understood by unfamiliar listeners by the age of 3 or 4 years. Receptive and expressive language: There are foundations that occur before the first words, and often before the first birthday, including behaviors such as attending to sound, looking at a communication partner, using gesture, and attempts to imitate speech. Around the first birthday, most babies are able to speak their first word or words. By approximately 18 months, the average child will be speaking about 10 to 50 words. Around the second birthday, we anticipate that baby will be on the path to putting together short two-or-three word phrases (e.g., “more juice,” “daddy go”). Between years one and two, we expect that a child will be able to point to basic body parts and follow simple commands and engage in representational play. Most parents will report an “explosion” of language throughout the
toddler years. As children progress, parents and professionals should note that language continues to evolve rapidly without plateaus. For instance, the average 2 to 3 year old will be able to label nearly all of the age-appropriate objects in his/ her environment and start to show greater interests in books and oral stories. By the age of 5, we expect children to be “school ready.” This involves following two-step directions, knowledge of basic concepts (“in” “on” “under” etc.) and the ability to relay a short story or event.
Other important considerations
communication partners with adults until later ages.
English-language learners and bilingual children: Children who are raised in multilingual households, or are immigrants to the area, present with other important factors to consider. First, it is necessary to consider
International adoption: Children who are adopted internationally come from many different genetic, cultural, and linguistic backgrounds. They are adopted at varying ages and stages of development. They
Childhood speech and language disorders are common, but may be overlooked and underdiagnosed.
What to expect with a referral SLPs have a wide range of tools to use when assessing the speech and language of a young child. There are multiple standardized and norm-referenced assessments to evaluate the form, content, and function of language. As the child progresses through school, these assessments include higher-language functions (idioms, metaphors, similes, and implied meaning) and assessments of the sound system of the language that are important for literacy and educational success. Often overlooked as a service delivery option for very young children, is the public school system. If children meet the criteria for special education service, public school systems are mandated to provide early intervention services to children and their parents from birth through 21 years of age. It is important to remember that a referral to a school-based SLP and early intervention team can set the stage for later academic development. If children do not meet the criteria for services through the public schools, other service delivery options for children with speech and language disorders include hospitals, medical centers, and private practice clinics. These settings generally require either insurance that covers habilitative services or the family’s ability to pay out of pocket. Some community providers may offer services with a sliding fee scale.
whether the child presents with language difference (speaking a language other than that of the dominant culture) or a true disorder. If parents suspect that their child may be lagging in language development, it is important to sift through the facts to determine which language/s is/are affected and whether delays or a disorder are present. SLPs work with parents, children, interpreters, community elders, and cultural representatives to ascertain language status, social and pragmatic norms for the group, and speech sound development across the languages that the child may be speaking. It is important to assure parents that learning two languages does not impair or slow the development of the other language. Indeed, being bilingual is an advantage. Some language milestones appear to be universal, but expectations and specific milestones may vary by culture and amount of exposure to language. Parent expectations may be higher or lower in certain areas of development. For example, parents may be more concerned about developmental skills, such as toilet training, depending on when children in their culture typically achieve these milestones. They may not be overly concerned with a child who is not communicating, particularly if they are from a culture that does not expect children to be active
may have come from environments in which they received little or a lot of attention from caregivers. All of these factors will influence their speech and language development. It will take time for the child to become fluent in the language of their new home. They will likely go through a period of time when they talk very little
as they realize that no one understands their first language—and they have not yet acquired enough of their new language to be functional communicators. Children who are adopted internationally warrant close attention to their development. If they are not developing communicative skill in their new homes, it is a good idea to refer them for further evaluation. Research indicates that play skills, interaction skills, and the rate of acquisition of the new language can provide early insight into their overall communicative abilities. Pragmatic and social factors are becoming more important in the evaluation of young children who present with developmental concerns. There are increasing numbers of children diagnosed with autism spectrum disorder, and appropriate use of language is a challenge for children on the autism spectrum. The SLP assesses Speech and language development to page 38
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Special Focus: allied providers
015 was an important year for recognizing the challenge of the increasing number of chronic pain sufferers, and our subsequent addiction to painkillers. Over 250 million opioid prescriptions were filled in 2015. All in all, far too much is being prescribed, without enough focus on creating the outcomes we are seeking to create—the dissolution of pain. In August of 2015 at the PAIN.PILL.PROBLEM Conference, Chris Johnson, MD (see his article in this issue of Minnesota Physician), presented a detailed history of the consistent upward trend of opioid use over the last two decades, highlighting the contributing elements from all participants—patients, providers, academics, and marketers. The result of these confluent factors is that opioid prescriptions in the U.S. have increased 300 percent since 1999 according to the CDC, and the 2009 National Survey on Drug Use and
Acupuncture, pain, and integrative care A first line of defense By Karen Lawson, MD, ABIHM, and John Blaska, DAOM Health stated that the United States contains 5 percent of the world’s population and consumes 80 percent of the world’s opioids. Confirming that this is a serious problem, the United States Substance Abuse and Mental Health Services Administration reported in 2013 that almost 2 million Americans, age 12 or older, either abused or were dependent on opioid pain relievers. One of the major influences in the surge in opioid prescriptions occurred in 2001 when the Joint Commission introduced the pain scale, now seen
in almost every emergency department and clinic across the country. It was here that the pain protocol became a vital metric for every clinic visit and clinic outcome. The observation of pain increased the diagnosis and recognition of pain by both patients and providers. The acknowledgement of pain and the diagnoses of the causes of pain led to pain reduction being a well-intended primary objective of every provider. Without non-opioid options being recognized, valued, and commonly available, a pharmaceutical response to pain recognition was the only available response. Reducing chronic pain
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Minnesota Physician February 2016
The CDC introduced new opioid prescribing guidelines in December 2015. These guidelines, alongside a number of state and federal legislative initiatives, have been introduced with the hope of curbing the issues in the wake of our country’s opioid addiction. However, they seem to focus on anything but the core issue— pain. To effectively reduce our dependence on opioids, we must identify strategies for the dissolution of pain, not just chronic pain management. The only place to implement these strategies effectively is through the relationship between patients and providers. The 2010 Global Burden of Disease Report identifies low back pain as the leading cause of disability worldwide. This growing body of chronic pain statistics solidifies the imperative that we must utilize all of our abilities and refocus our commitment to reduce and eliminate chronic pain altogether.
An effective solution for pain This past October at the Academy of Integrative Health & Medicine conference, Scott Haldeman, DC, MD, PhD, an adjunct professor in the Department of Epidemiology at UCLA, discussed the demand that musculoskeletal disorders place on our health care system. He presented that randomized controlled research favors acupuncture as one of the more effective therapeutic interventions for neck pain according to the Journal of Manipulative and Physiological Therapeutics (January-February 2009) and low back pain according to the Current Sports Medicine Reports (February 2010), followed by chiropractic and physical therapy.
There are over 500 board-certified, licensed acupuncturists in Minnesota. Courtney Baechler, MD, vice president at the Penny George Institute for Health and Healing (PGIHH), presented at the PAIN.PILL.PROBLEM Conference that a retrospective study, published by PGIHH in BMC Complementary and Alternative Medicine (December 2014), of 6,589 cardiovascular admissions who used integrative pain interventions, including acupuncture, found that there was a 46.5 percent reduction in pain and a 54.8 percent reduction in anxiety, which resulted in faster recovery times and substantial cost savings. One key component within this research was allowing the provider to assess the needs of the patient and to make sure that therapies were customized to the patient. Dr. Baechler also reported that when dealing with pain, acupuncture is her first recommendation for a therapy. Research by Mark Corbett, Research Fellow at the University of York, et al., in Osteoarthritis and Cartilage
(September 2013) reported that in a systematic review of 156 studies, acupuncture was found to be an effective treatment for osteoarthritis of the knee.
thoughtfully reduce our reliance on opioids as a solution for pain. The following can help you begin a conversation with a licensed acupuncturist:
Through improved methodologies and clearer objectives, research confirms why acupuncture has had such longevity as an effective and affordable therapy. Eliminating pain by correcting the injury and enabling the tissue to heal must become a focus of providers caring for injured patients. The facilitation of healing an injury may take time, 90 days or more, as opposed to just managing the pain, which often remains unresolved. While pain can guide, it also may interfere with recovery. This is where pain management resources, other than acupuncture, may be leveraged if needed. But these high-risk resources should only bridge the gap when episodic pain becomes debilitating. Opioids should not be the primary intervention over time.
• Acupuncture is a medical therapy practiced around the world where filiform needles are inserted into the body to elicit a therapeutic response with minimal secondary consequences (i.e., side effects).
Once enough progress has been made in the repair of the tissue, pain management substance use should decrease, and the focus should be on the recovery protocol. Acupuncture as a therapeutic intervention, especially for pain, is well established in the U.S. and as of January 2015 is now part of the Joint Commission’s protocol for pain. It is used in approximately 140 countries around the world, at sites that range from hospitals to the battlefield to rural clinics and natural disaster zones. Acupuncture is one of the most affordable therapies we have in our medical resource pool and has very few risks with little to no side effects when performed by well-trained acupuncturists, as presented in a published review of 229,230 patients by Witt, et al., in Forsch Komplementmed (April 2009). What providers need to know It is time to begin to break down the barriers of misunderstanding, build bridges for better integrative care, and
Conclusions “Primary health care is essential health care based on practical, scientifically sound, and socially acceptable methods and technology…. It is the first level of contact…bringing health care as close as possible to where people live and work and constitutes the first elements of a continuing health care process.” (WHO, 1978)
Acupuncture as a therapeutic intervention … is now part of the Joint Commission’s protocol for pain.
and with growing retrospective evidence acupuncture demonstrates safety and efficacy as a reliable medical therapy. The trend for using acupuncture as an alternative or experimental last resort in the United States needs to give way to where acupuncture is the first option for reducing or eliminating pain and a key early component of sound integrative care plans. It is time for physicians and licensed acupuncturists to collaborate and integrate to improve the standard of care for all patients.
Karen Lawson, MD, ABIHM, is direc-
• There are approximately 200 well-known systemic strategies and techniques used synergistically by licensed acupuncturists. Some are as old as the Huang Di Nei Jing (circa 100 CE) and some are as up to date as the 2015 neuro-acupuncture techniques practiced in top-level hospitals for stroke recovery, Parkinson’s, etc. • While many of the strategies used in modern acupuncture have East Asian origins and subsequent histories there are many techniques that are not limited by cultural designation. Acupuncture and instrument-assisted acupressure both are used in many historical and modern cultures and are a part of the training for board certification in acupuncture.
This statement made at the World Health Organization’s (WHO) International Conference on Primary Health Care in 1978 rings as true now as it did back in the ‘70s. With better research design, acupuncture is holding its own within the randomized controlled trial framework. Used all over the world
tor of Integrative Health Coaching at the University of Minnesota Center for Spirituality & Healing, and is past president of the American Holistic Medical Association. John Blaska, DAOM, is a board member of the Acupuncture and Oriental Medicine Association of Minnesota, specializes in integrative healthcare clinic model development, and is founder and president of Everspring Health.
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• There are over 500 board-certified, licensed acupuncturists in Minnesota. Training consists of masters or doctoral level education, including board certification in biomedicine. • Acupuncture is a therapy. Like all therapies, a complete and well thought out program is required for optimal results. For issues like pain, this usually means 12+ treatments and/or 90 days to lead to optimal and sustainable outcomes.
February 2016 Minnesota Physician
he VA medical system, established in 1921, is now the largest integrated health care system in the U.S., caring for 9 million veterans at 150 medical centers and 800 community-based clinics. Over 70 percent of currently practicing physicians received some training at a VA facility. As early as 1925, visionary leaders had created a rudimentary research program within the VA, believing that such a program would enhance the VA’s clinical care mission by attracting academic physicians, but it was not until after the Second World War that this vision became a reality. In 1945, the VA established a research and education service and VA hospitals soon began developing affiliation agreements with medical schools, adding teaching and research to VA’s core clinical care mission. The Minneapolis VA was the second VA in the country to affiliate, establishing its relationship with the University of Minnesota in 1946. Finally, in
The VA medical system Ninety years of discovery and innovation By Hanna E. Bloomfield, MD, MPH 1955, Congress authorized an explicit VA research budget for the first time thus inaugurating the modern era of VA research. Early VA research included landmark work leading to the first effective treatment for tuberculosis (streptomycin), the development of the cardiac pacemaker and CT scanning, the first successful human liver transplant, the use of radioisotopes in clinical medicine, and the Gleason grading system for prostate cancer, still in use today. Minneapolis-based VA researchers, Leslie Zieve, MD, and Donald Gleason, MD, PhD, were key contributors to the latter two innovations.
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Keynote Speakers Gary L. Cunningham, Metropolitan Economic Development Association (MEDA), Minneapolis —Creating a New Narrative for Community Engagement in Health Care
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Minnesota Physician February 2016
The VA’s national research program The mission of the VA research program is to discover knowledge and create innovations that advance health care for veterans and the nation. The program comprises four services: laboratory; clinical—which includes the prestigious VA cooperative studies program; health services; and rehabilitation research. The total annual budget for VA research is around $1.8 billion, of which about a third is appropriated by Congress, another third comes from the VA medical care appropriation, and the rest from other federal and non-federal entities such as the National Institutes of Health, the pharmaceutical and medical device industry, and foundations. VA research priority areas include conditions related primarily to combat (e.g., traumatic brain injury, amputations, and PTSD) or to military environmental exposure (e.g., Gulf War syndrome, Agent Orange); and those that are prevalent in the VA (e.g., chronic disease, mental illness, substance abuse, and aging-related disorders). The majority of VA-funded research is investigator initiated. Proposals undergo rigorous peer-review and generally need to score above the 80th percentile to secure funding. The VA also funds research centers of excellence focusing on specific content areas and career development awards to ensure a steady pipeline of well-trained VA investigators.
research program, now 70 years of age, is one of the oldest and largest. We currently have 140 investigators, some of whom are basic scientists, but most are physicians actively involved in patient care. Most investigators have University of Minnesota Medical School faculty appointments. These investigators conduct over 400 research projects, 140 of which are federally funded, with total research funding averaging around $26 million a year. About half of that funding comes from the National Institutes of Health. Minneapolis VA investigators publish over 300 scientific articles in peer-reviewed journals every year. Of the 32 faculty with highly cited papers featured on the University of Minnesota’s Medical School’s Wall of Scholarship, four are based primarily at the Minneapolis VA. The Minneapolis VA hosts four research centers: • The Center for Chronic Disease Outcomes Research conducts epidemiologic, health services, and outcomes research focusing on evidence-based therapies for PTSD; cancer prevention and screening; and treatment of chronic pain. • The American Legion Brain Sciences Center conducts studies on schizophrenia, Alzheimer’s Disease, alcoholism, and mechanisms of cognitive function, memory, and learning. These studies often use sophisticated neuroimaging techniques including functional magnetic resonance imaging and magnetoencephalography.
The Minneapolis VA’s research program
• The Geriatric Research Education and Clinical Center conducts basic science, clinical, health services, and outcomes research in neurodegenerative diseases, including Alzheimer’s and Parkinson’s disease, and in other age-related disorders such as obesity, bone fragility, and cardiovascular disease.
Of the 150 VA medical centers, 90 have an established research program and Minneapolis VA’s
• The Department of Defense/ VA Brain Injury Center provides education, care
coordination, and research services to veterans and active duty service members with traumatic brain injury (TBI). Areas of research investigation include the association between TBI and neurodegenerative disease and the therapeutic use of transcranial direct current stimulation to improve cognitive control in people with TBI. Additional areas of active research investigation include: • Rehabilitation for spinal cord injuries and amputations • Smoking cessation and lung disease • Osteoporosis • Infectious diseases (e.g., urinary tract infections; influenza and shingle vaccines) • Cardiovascular diseases (e.g., heart failure, treatment of abdominal aortic aneurysms, and hypertension)
Recent research findings from the Minneapolis VA Examples of recent Minneapolis VA research findings that have generated national interest in professional circles and in the lay press are listed here. Mobile Manual Standing Wheelchair: Biomedical engi-
team also developed a prosthetic foot that adapts to differing surface slopes on each step of walking providing increased comfort and requiring less exertion for people with lower limb amputations (Journal of Rehabilitation Research and Development, May 2014).
Veterans are willing and often eager to participate in research studies.
neer Andrew Hansen, PhD, and his research team in collaboration with physiatrist Gary Goldish, MD, created a prototype wheelchair that not only lets people with spinal cord injury stand, but enables them to move while in the standing position. To see a video of this amazing wheelchair go to http://bit.ly/ spinechair Shape and Roll Prosthetic Foot: Dr. Hansen’s research
Vitamin E for Alzheimer’s: A national multicenter randomized controlled trial led by Maurice Dysken, MD, reported that daily supplemental vitamin E significantly delayed decline in cognitive functioning in patients with mild to moderate Alzheimer’s Disease (JAMA, January 2014). Watch and wait in early prostate cancer: A national multicenter randomized controlled
trial led by Timothy Wilt, MD, MPH, reported no difference in 10 year survival between men who had their prostate removed surgically at the time of diagnosis and those who were followed closely without initial surgery (New England Journal of Medicine, July 2012). Mindfulness-based stress reduction for PTSD: A randomized controlled trial led by Melissa Polusny, PhD, found that an eight week intervention focused on mindfulness resulted in significant reductions in PTSD symptoms compared with the control condition (JAMA, August 2015). Expressive writing in veterans with PTSD: In a nationwide randomized controlled trial of >1,200 Iraq and Afghanistan veterans reporting reintegration problems, investigators led by Nina Sayer, PhD, reported that writing about the experience of transitioning to civilian life was associated with less anger, The VA medical system to page 33
February 2016 Minnesota Physician
Professional Update: Emergency Medicine
t is 7 p.m. on a Friday evening and you are hitting the home stretch of your noon to 9 p.m. swing shift in the emergency department (ED). So far it has been a reasonably good day, but it has been busy and you are looking forward to calling it a night. You pick up the “next to be seen” chart and see the chief complaint of “back pain.” You feel a little uneasy. You scan the chart for more information and see the patient is a 41-year-old male, brought in by ambulance for “severe right lower back pain.” However, the nurse’s note clarifies that the medics saw him walk briskly to the ambulance after they arrived at his house. He had an IV placed and received 8 mg of morphine before arriving at the ED. You look up his electronic record and see that he has a history of chronic back pain and is prescribed OxyContin and Percocet. You find him on the bed in some discomfort though still
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able to text on his phone. You introduce yourself and ask what you can do to help. He explains that he was helping a friend move three days ago and exacerbated his back pain. He says he tried to “tough it out” until he could get into his regular clinic but could not wait any longer. He called his clinic at 5 p.m. and they told him to come to the ED. He assures you that he would not normally have come to the ED because he “does not like hospitals” or “taking medications” (though review of his electronic record might indicate otherwise). He
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Minnesota Physician February 2016
explains that his regular medications “aren’t working” and his current pain level is a “14 out of 10!” While you are summoning up your energy reserves for what could be a challenging encounter, you are aware of another thought—this patient is at very high risk of joining the many thousands of Americans who die each year from prescription opiate overdose. This vignette is an amalgamation of many patient encounters. It combines multiple elements that are all too commonplace for those of us in emergency medicine. Especially common are the mathematical impossibilities reported when the patient is asked to rate their pain from 0 to 10. This type of encounter, more often than the unresponsive patient who is overdosing, represents the most commonly observed face of the prescription opiate epidemic in the ED. And while this scenario has its frustrations and absurdities, the end result for these patients is often far more devastating—dependence, addiction, overdose, and death. This combination of frustration and tragedy is playing out with ever-increasing frequency in Minnesota and across the nation. But for all the stresses these interactions can bring to physicians, nurses, and other providers, the reason we are seeing so many of these patients in our EDs and clinics is simple: We did it to ourselves. The problem Since the late 1990s there has been an explosion in the prescribing of opiate pain medication. As a result of advocacy programs such as treating pain as the “Fifth Vital Sign” and aggressive marketing
by the pharmaceutical industry, the number of prescriptions has tripled from 76 million in 1991 to 219 million in 2011 (Vector One National). According to CDC data, the United States now contains 5 percent of the world’s population but we consume 80 percent of the world’s opiates, including 99 percent of the world’s hydrocodone. Led by academics in the leading pain societies and supported by pharmaceutical companies eager to enter new markets, it was argued that opiate pain medicines should be used for chronic pain conditions such as back pain or headaches, conditions that historically were not treated with opiates. This broadening of prescribing indications was also notable for its lack of data about long-term safety and efficacy. In 2014, the NIH conducted a Pathways to Prevention research project that looked into the use of opiates for chronic non-cancer pain and found no studies lasting longer than 12 weeks. Yet in 2000, the FDA approved the broader use of opiates for these conditions despite the lack of data. This expansion of opiate prescribing has been very profitable for certain stakeholders, notably the pharmaceutical industry. Purdue Pharma routinely sells over $2 billion worth of OxyContin per year. The public health consequences have been nothing short of a disaster. CDC data show that the number of accidental prescription overdose deaths have increased dramatically since 1999 and continue to get worse. According to CDC data just released this past December, almost 19,000 Americans died of inadvertent prescription opiate overdose. In 1999, that number was 4,030. In lockstep with the rise of prescription opiate abuse has been the increasing use of heroin and subsequent overdoses, with over 10,000 dead in 2014. We would not tolerate a war where this many Americans died. Yet the vast majority of these deaths come at the hands of modern medicine. From 2005 through 2014, the total number of Americans who have died due to
inadvertent prescription opiate overdose is a stunning 154,159. This is a badge of shame on the medical profession. The good news, if one can call it that, is that Minnesota does better than most states in avoiding the worst of the carnage. Our death rate per 100,000 is among the lowest in the nation at 7.4, whereas West Virginia is the worst at 28.9 per 100,000. It was not a surprise therefore that President Barack Obama chose to speak about this crisis from Charleston, the capital of West Virginia, this past October. But our trends are no less worrisome—according to the Minnesota Department of Health there were 317 opioid-related deaths in 2014, a sixfold increase from 2000. That 317 represents more deaths than from motor vehicle accidents. The role of the ED Most patients do not get the majority of their opiates from the ED. According to the FDA, only about 5 percent of opiates are prescribed in the ED whereas about 43 percent come from primary care providers— internists and family medicine practitioners. However, the ED is very much affected by the costs associated with visits due to abuse of these medications. According to data published in JAMA in 2014, there were over 92,000 emergency visits for prescription opiate overdose in 2010 at a cost of $1.4 billion. Even more common are visits for non-medical use. According to the CDC, in 2009 there were almost 500,000 ED visits nationally for opiate misuse, contributing to over $70 billion in cost per year to insurers. Locally, we have been first-hand witnesses to this tidal wave of patients. According to the 2012 report from the Drug Abuse Warning Network, from 2004 to 2011, the number of ED visits in the Twin Cities related to opiates increased from 1,940 to 4,836. Hardly a shift goes by without my seeing at least one patient who is on chronic opiates for pain. The bottom line is despite the fact that we may not be the major source of the
medications for these patients, we still see and are impacted daily by the vast numbers of patients who are caught up in this crisis. As ED physicians we must act together with our partners in other specialties to help solve this.
to avoid confrontation and no one in hospital administration, the Board of Medical Practice, or a malpractice attorney would even notice. To solve this will require a revision of what we consider to be appropriate conditions
The United States now contains 5 percent of the world’s population but we consume 80 percent of the world’s opiates.
The solution So what are we going to do about this? I would like to assure you that with better education and “awareness” this problem will be solved. But I can’t. Because despite attempts to educate people about this problem nothing has happened. Despite pain contracts, opiate policies, task forces, and educational forums, the numbers are not improving and, in fact, are getting worse. Not even the Prescription Monitoring Program has had any impact on patient outcomes. In my opinion, medicine does not have the incentive structure to solve this on its own. The pressures an ED or primary care doctor faces to meet corporate imperatives, such as making sure the patient has a good “experience” and fills out a favorable survey, are substantial. Patient complaints always come to the attention of the administration. Even if you provide responsible care, a patient can go elsewhere if they are not satisfied. Administrators and hospital executives are incredibly sensitive to this and want to keep as many patients as possible. In short, the incentives are to make a patient happy in the short term even if the care provided contributes, however incrementally, to long-term adverse consequence but for which no long-term culpability exists. In the earlier scenario, the doctor could simply have written a prescription for 20 tablets of Percocet
for opiate pain medicine and support for the clinicians to make that happen. Above all, we have to show, as a profession and health care industry, that we care and are not simply maximizing relative value units. We have to turn back the clock to when the first disastrous, ill-informed
decision was made to expand opiates for chronic non-cancer pain. We need to stop creating these patients who, over years, become completely dependent on opiates. For those patients already over-medicated, if not outright dependent, we have to help them. If at all possible we should try to wean them of these medicines and find safer alternatives for their pain. We need to introduce transparency in prescribing practices. A “dashboard” should be created on a state level that lets physicians know how much they are prescribing per patient relative to his or her peers. This should be normalized for specialties—an ED doctor will prescribe more opiates than an ophthalmologist and both will prescribe less than a pain or addiction specialist. This should not be a means to target physicians or “get them in trouble.” Rather, getting this information out in the open is an Dying from prescription heroin to page 32
February 2016 Minnesota Physician
Dying from prescription heroin from page 31
important way of showing that we care—that we are paying attention. To continue in secluded anonymity, even secrecy, is to convey the message that what really matters to us in medicine is repeat customers, not safety. We also need to be honest with ourselves and our patients and acknowledge these medicines for what they are—oral versions of heroin. Heroin is not a malevolent, bizarre category of opioid. It has a scientific name, diacetylmorphine, and was first brought to us by the good people at Bayer Pharmaceuticals in the late 19th century. Furthermore, diacetylmorphine is used every day in the United Kingdom for a responsible purpose—the treatment of pain for acute injury. The United Kingdom should serve as an important lesson to us as well—namely, that we can get by in life with our aches and pains without a river of opiates
in our systems. The British population suffers the same maladies as we do including chronic back pain. However, they do not take nearly the amount of opioids we do nor do they die at the same rate. The reason is they simply do not treat chronic pain with opioids. According to their bureau of statistics, in 2011, less than 750 died of
From 2005 through 2014, the total number of Americans who have died due to inadvertent prescription opiate overdose is a stunning 154,159.
this current environment. But the sheer numbers showing the devastation to our patients and their families has to win the day. We have to change. This will require investment from all those with a stake in public health—from our health care providers and clinics, to our political and community leaders, to insurance payers and law enforcement, to patients and families. This will not be corrected overnight, but it is time that we start to fix our opiate epidemic. Our patients deserve better. In fact, we all do. Chris Johnson, MD, is an emergency
prescription opiate overdose (which was still very worrisome to them). If they died at the same rate as those in the U.S. and adjusted for their smaller population of 63 million, their total of overdose deaths would
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be over 3,500. That roughly corresponds to 2,800 lives saved in that one year alone. I think we should be capable of similar results. There is no reason to think the British are inherently more able to cope with chronic pain than we are. The lives we save will number in the tens of thousands.
Minnesota Physician February 2016
Conclusion Such an extensive culture change is ambitious and will take time to implement. There will likely be protest to such change, especially from those who are actually thriving in
physician who practices in the Twin Cities. He is a member of the Minnesota Chapter of the American College of Emergency Physicians and serves on the Department of Human Services Opioid Prescribing Work Group.
The VA medical system from page 29
physical complaints, and distress compared with the control condition (Journal of Traumatic Stress, October 2015). Fecal microbiota transplantation for C. Difficile infection (CDI): A systematic review by Dimitri Drekonja, MD, MS, and colleagues concluded that this intervention was safe and resulted in symptom resolution in 75 to 85 percent of people with recurrent CDI (Annals of Internal Medicine, May 2015). Value of the routine pelvic examination: A systematic review by Hanna Bloomfield, MD, MPH, and colleagues was the basis for the American College of Physicians Guideline recommending against routine pelvic examination in asymptomatic, average risk women not due for a Pap smear (Annals of Internal Medicine, July 2014). Colonoscopy withdrawal time and incidence of colorectal cancer: A large retrospective
cohort study conducted by Aasma Shaukat, MD, MPH, and colleagues evaluating more than 75,000 colonoscopies conducted in the Twin Cities area found that patients in whom withdrawal times were < 6 minutes, compared to > 6 minutes, were twice as likely to develop colorectal cancer during the ensuing five years (Gastroenterology, July 2015).
comment that they are enrolling to help those who will enlist in the future. In addition, the VA was one of the first health care systems to introduce the electronic medical record so researchers can now access many yearsâ&#x20AC;&#x2122; worth of clinical and administrative data on more than 9 million patients throughout the U.S. This unparalleled database and the altruis-
Having strong research and education programs attracts top-notch health care providers. Conclusion VA research has flourished over the last 90 years first and foremost because veterans are willing and often eager to participate in research studies. While realizing that they may not derive any personal benefit from participation, veterans feel a strong sense of kinship with other veterans and often
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tic impulses of so many veterans have been key factors in the success of the VA research enterprise. Although VA research has a major impact on the advancement of science and the practice of clinical medicine, its value for the quality of care that veterans receive at VA hospitals
is a collateral benefit that is perhaps just as important. Having strong research and education programs attracts top-notch health care providers to the VA system and creates a culture of inquiry, discovery, and the practice of evidence-based medicine. Individual veteran patients benefit from receiving care at an institution that fosters this culture. Indeed, empirical data show that the quality of care in teaching hospitals is consistently better than in community hospitals (see, for example, David Shahian, MD, et al., Academic Medicine, June 2012). To find out more about the research program at the Minneapolis VA please visit us at www.minneapolis. va.gov/research/. Hanna E. Bloomfield, MD, MPH, is a
board-certified general internist. She is associate chief of staff for research at the Minneapolis VA Health Care System and professor of medicine at the University of Minnesota.
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hen President-elect Barack Obama took office in 2009, one of his first commitments was that within five years, all American citizens’ medical records would be computerized. Since that bold pledge, billions of dollars have been committed to the task of transitioning providers to electronic systems. Without question, the Centers for Medicare & Medicaid Services’ (CMS) commitment to make incentive payments to hospitals and providers, along with a penalty for failure to adopt electronic health records (EHRs), was the primary motivator for providers to transition to electronic health records. With the government’s backing, the EHR market is expected to reach approximately $10 billion annually in 2016. The function of electronic health records Generally, the use of the term “electronic health record” means simply the electronic records maintained by
Electronic health record systems Choices, challenges, and dollar signs By Timothy A. Johnson, JD, and Julia C. Marotte, JD providers of their patients’ health information. Despite its seemingly simple definition, EHRs have transformed health care delivery across the nation. By maintaining patient health records in an electronic format, providers have the ability to use, access, verify, share, transfer, and manipulate patient health information quite easily—or that was the intent. Obviously, the primary EHR system function is to maintain patient medical records in an electronic format. While maintaining patient medical records may seem like a simple task, the ability to integrate
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Minnesota Physician February 2016
patient health information from a variety of sources over time into a format that can be used effectively by multiple providers is extremely complicated. Ideally, each individual should have a single record that houses all of their health information. This could include health information from primary care and specialty physicians, hospitals, laboratories, imaging centers, pharmacies, therapists, etc. However, the task of effectively gathering such information into a single electronic record and displaying it in a meaningful manner has proven to be a major obstacle. In several surveys about EHR systems, providers cite poor data display as their primary complaint.
plans, additional tests, follow-up appointments, and additional medical information. As you can imagine, these EHR data verification capabilities provide significant benefits to providers and patients—it helps providers avoid medical errors and assists them in preparing the best possible treatment plan for the patient. However, this function is not without its drawbacks. Every data verification task is followed by an electronic alert, notifying the provider of the outcome or additional information. A common complaint is that this function produces an overwhelming amount of alerts and notices, causing providers to experience what is known as “alert fatigue.” It is difficult to attend to each and every alert and, ultimately, providers begin to ignore them. This data verification function, while initially thought to be immensely valuable, often has less value in practice. Interoperability issues One of the most significant issues regarding the adoption of electronic health record systems has been the interoperability of
Most providers have been using their existing EHR system for three to five years.
Medical record data verification The capabilities of modern EHR systems extend beyond just maintaining patient health information. Most systems have the ability to review and analyze patient information to not only identify potential issues and concerns with a particular diagnosis, but to also assist the provider in identifying the optimal treatment plan. For example, most EHR systems today will analyze the patient’s medical history and prescription information to alert the provider to possible allergic reactions or drug interactions. Similarly, when providers diagnose a patient’s condition, the EHR system can alert the provider to possible treatment
the systems. Interoperability, which generally means the ability of two or more systems to exchange information and use the information that has been exchanged, is a key requirement of an approved CMS EHR system. It is more than just the ability to transfer data from one system to another—interoperability is the ability to seamlessly exchange and integrate patient health information across multiple systems. The inability of EHR systems to effectively and seamlessly exchange patient health information continues to be one of the most significant shortfalls. While companies may tout their EHR system’s compliance with CMS’ interoperability requirements, most providers
continue to experience significant problems accessing and exchanging patient information across a vast spectrum of providers using different systems. CMS recently suggested that some EHR vendors are intentionally bypassing interfaces that would allow their systems to effectively integrate with other systems. From a business perspective, there are advantages to being compatible with only sister-products, as it pressures customers into purchasing products from the same vendor in hopes of achieving system compatibility. CMS has indicated that it will investigate these claims and take appropriate actions against those vendors that have not been completely cooperative in embracing interoperability. An abundance of EHR systems Probably the biggest cause for interoperability issues is the vast number of different EHR systems on the market. By some reports, there are more than 30 different companies building
systems. With this many players it is not surprising that the systems are unable to seamlessly exchange information. Providers tasked with selecting an EHR system are
categories such as critical access or academic hospitals. Each of these provider types has its own list of EHR features that are important. With this level of distinction, it is not surprising that the market entry for new EHR vendors and systems continues to grow.
are large groups, small groups, multi-specialty groups, and single specialty groups. Similarly, hospital categories range from large urban hospitals to rural hospitals, and include unique
The inability of EHR systems to effectively and seamlessly exchange patient health information continues to be one of the most significant shortfalls.
Selecting an EHR system Generally, when selecting an EHR system a provider focuses almost exclusively on the system’s EHR capabilities (with Electronic health record systems to page 36
required to assess each system against the provider’s particular operational needs and wants. Inevitably, different provider types value different capabilities. For example, physician groups likely want an EHR system that has the best features for physician services, whereas a hospital provider will prefer a system that caters to inpatient services. The preference distinctions go on and on—within the physician group category there
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Electronic health record systems from page 35
the second-most important factor being price). While the individual EHR system components are certainly important, the full value of an EHR system can only be realized if the system is effectively integrated with the provider’s other electronic systems. EHR systems will interact with the provider’s scheduling software; billing and coding software; financial accounting software; health plan payer information; and preauthorization requirements. It is of course best to use an EHR system that interacts seamlessly with these other programs. However, as already noted, systems from different vendors often do not have the capability to connect or interact. Moreover, there is no leading system in the market—rather, the highest-ranking modules are sold by several different vendors. This issue complicates the EHR system selection process.
Providers must decide whether to buy a single “enterprise system” that includes all of the modules from the same vendor, or whether to pick and choose only the best modules from different vendors. Providers that buy a single enterprise system that includes all of the modules from the same vendor typically have fewer problems with
effectively the modules interact with the other modules and the EHR system. Conclusion EHR systems are no longer a thing of the future—true to President Obama and CMS’s commitment, they are ingrained in today’s health-care delivery system. However, the systems are far from perfect.
The capabilities of modern EHR systems extend beyond just maintaining patient health information.
how the modules connect and interact. However, these providers also find issues with the quality and capabilities of each module. Conversely, providers that buy the best module from a variety of different vendors complain of higher costs and experience problems with how
Providers experience interoperability problems and alert fatigue, and the market has become fragmented. On top of it all, EHR systems can be extraordinarily expensive. At this point, most providers have been using their existing EHR system for three to five years
A Diverse and Vital Health Service A Diverse and Vital Health Service Welcome to Boynton Health Service Welcome to Boynton Health Service
Located in the heart of the Twin Cities East Bank campus, Boynton Health Service is a vital in part the University ofCities Minnesota community, ambulatory Located theofheart of the Twin East Bank campus,providing Boynton Health Service care, health and public health services to the University for nearly 100 is a vital parteducation, of the University of Minnesota community, providing ambulatory years. It’s oureducation, mission toand create a healthy community by working with care, health public health services to the University forstudents, nearly 100 staff, and faculty to achieve physical, emotional, and social well-being. years. It’s our mission to create a healthy community by working with students, staff, and faculty to achieve physical, emotional, and social well-being. Boynton’s outstanding staff of 300 includes board certified physicians, nurse practitioners, registeredstaff nurses, CMAs/LPNs, physician assistants, dentists, Boynton’s outstanding of 300 includes board certified physicians, nursedental hygienists, optometrists, physicalCMAs/LPNs, and massage therapists, registered dietitians, practitioners, registered nurses, physician assistants, dentists, dental pharmacists, psychiatrists,physical psychologists, and social workers. Our multidisciplinary hygienists, optometrists, and massage therapists, registered dietitians, health servicepsychiatrists, has been continuously accredited by AAAHC and was pharmacists, psychologists, and social workers.since Our 1979, multidisciplinary the first college health service to have earned this distinction. health service has been continuously accredited by AAAHC since 1979, and was the first college health service to have earned this distinction. Attending to over 100,000 patient visits each year, Boynton Health Service takes pride in meeting healthpatient care needs U ofyear, M students, Attending to overthe 100,000 visitsof each Boynton Health Service takes staff, faculty with compassion pride and in meeting the health care needs of U of M students, and staff,professionalism. and faculty with compassion and professionalism.
and are familiar with their system’s positive and negative features. Many vendors believe that the initial wave of early EHR system users will begin exploring alternative systems over the next few years and that users may abandon their current system. Given the number of available vendors and the problems caused by the fragmented market, this is certainly a possibility. However, only time will tell. Timothy A. Johnson, JD, is a principal at Gray Plant Mooty and a member of its Health & Nonprofit Organization Practice Group. Julia C. Marotte, JD, is an associate at Gray Plant Mooty and a member of its Health & Nonprofit Organization Practice Group.
Join the attorneys of Gray Plant Mooty’s Health Law Practice Group at the 20th Annual Gray Plant Mooty Health Law Conference, held July 12 at The Depot in downtown Boynton Health Service Minneapolis. Boynton Health Service
Boynton Health Service Boynton Health Service
Physician Physician Boynton Health Service has an immediate opening for a full-time physician to provide services in the Primary Care and Urgent Boynton Health Service has an immediate opening for a full-time Care Clinics. Candidates should enjoy working in a college physician to provide services in the Primary Care and Urgent health environment with a large and diverse population of Care Clinics. Candidates should enjoy working in a college students and staff. health environment with a large and diverse population of students and staff. The qualified applicant must be ABMS board certified/eligible and have training and/or experience in an outpatient practice The qualified applicant must be ABMS board certified/eligible and urgent care. Knowledge of electronic health records would and have training and/or experience in an outpatient practice be beneficial. This position offers a competitive salary, CME and urgent care. Knowledge of electronic health records would opportunities, and a generous academic status retirement plan. be beneficial. This position offers a competitive salary, CME Professional liability coverage is provided. opportunities, and a generous academic status retirement plan. Professional liability coverage is provided. To learn more, please contact Hosea Ojwang, Human Resources Director, at 612-626-1184, firstname.lastname@example.org To learn more, please contact Hosea Ojwang, Human Resources Director, at 612-626-1184, email@example.com Apply online at http://www1.umn.edu/ohr/employment and search for keyword 306981. Apply online at http://www1.umn.edu/ohr/employment and search for keyword 306981. The University of Minnesota is an Equal Opportunity, Affirmative Action Educator and Employer. The University of Minnesota is an Equal Opportunity, Affirmative Action Educator and Employer.
410 Church Street SE • Minneapolis, MN 55455 • 612-625-8400 • www.bhs.umn.edu 410 Church Street SE • Minneapolis, MN 55455 • 612-625-8400 • www.bhs.umn.edu
Minnesota Physician February 2016
Family Medicine Minnesota and Wisconsin We are actively recruiting exceptional board-certified family medicine physicians to join our primary care teams in the Twin Cities (Minneapolis-St Paul) and Central Minnesota/Sartell, as well as western Wisconsin: Amery, Osceola and New Richmond. All of these positions are full-time working a 4 or 4.5 day, Monday – Friday clinic schedule. Our Minnesota opportunities are family medicine, no OB, outpatient and based in a large metropolitan area and surrounding suburbs. Our Wisconsin opportunities offer with or without obstetrics options, and include hospital call and rounding responsibilities. These positions are based in beautiful growing rural communities offering you a more traditional practice, and all are within an hours’ drive of the Twin Cities and a major airport. HealthPartners continues to receive nationally recognized clinical performance and quality awards. We offer a competitive salary and benefits package, paid malpractice and a commitment to providing exceptional patient-centered care. Apply online at healthpartners.com/careers or contact firstname.lastname@example.org, 952-883-5453, toll-free: 800-472-4695. EOE
MAYO CLINIC CLINIC HEALTH HEALTH SYSTEM SYSTEM is is aa family family of of clinics, clinics, MAYO MAYO CLINIC HEALTH SYSTEM is a family of clinics, hospitals, and other health care facilities serving more than than 60 60 hospitals, and other health care facilities serving more MAYO CLINIC HEALTH SYSTEM is a Wisconsin. family of clinics, hospitals, andinother health care facilities serving more than 60 communities Minnesota, Iowa, and Mayo Clinic communities Minnesota, Iowa, and Wisconsin. Mayo Clinic hospitals, andin health care facilities serving more than 60 communities inother Minnesota, Iowa, and Wisconsin. Mayo Clinic Health System System links the expertise expertise of Mayo Mayo Clinic in practice, Health links the of Clinic in practice, communities in Minnesota, Iowa, and Wisconsin. Mayo Clinic Health System links the expertise of Mayo Clinicsystems in practice, education and research research with the the health-delivery health-delivery of our our education and with Health System the expertise of Mayo Clinic insystems practice,of education and links research with the health-delivery systems of our local communities. local communities. education and research with the health-delivery systems of our local communities. local communities. The Northwest Wisconsin Region Region opportunities opportunities include: include: The Northwest Wisconsin The Northwest Wisconsin Region opportunities include: Dermatology Occupational Medicine Dermatology Occupational Medicine include: The Northwest Wisconsin Region opportunities Dermatology Medicine Emergency Medicine Medicine Occupational Ophthalmology (General & & Glaucoma) Glaucoma) Emergency Ophthalmology (General Dermatology Medicine Emergency Medicine Occupational Ophthalmology (General & Glaucoma) Family Medicine Orthopedics Family Medicine Orthopedics (General & Glaucoma) Emergency Medicine Ophthalmology Family Medicine Orthopedics General Surgery Psychiatry (Adult (Adult & & Child) Child) General Surgery Psychiatry Family Medicine Orthopedics General Surgery Psychiatry (Adult & Care Child) Hospitalist Pulmonary/Critical Hospitalist Pulmonary/Critical Care General Surgery Psychiatry (Adult & Child) Hospitalist Pulmonary/Critical Care Infectious Disease Disease Urgent Care Care Hospitalist Pulmonary/Critical Care Infectious Urgent Infectious Disease Urgent Care Internal Medicine Urology Infectious Disease Urgent Care Internal Medicine Urology Internal Medicine Urology Neurology Internal Medicine Urology Neurology Neurology Neurology Mayo Foundation Foundation is is an an affirmative affirmative action action and and equal equal opportunity opportunity Mayo Mayo Foundation isan anaffirmative affirmativeaction actionand andequal equalopportunity opportunity employer and educator. Mayo Foundation is employer and educator. employer and andeducator. educator. employer If you wish to learn more or or to to express express interest interest in in these these positions, positions, If you wish to learn more you wish wish to to learn more or to express interest in these positions, please contact us at 800-573-2580; email IfIf you learn more or to express interest in these positions, please contact us at 800-573-2580; email pleasecontact contactus usatat800-573-2580; 800-573-2580;email email@example.com; oremail apply at at please firstname.lastname@example.org; or apply email@example.com; or apply at http://www.mayoclinic.org/jobs/physicians-scientists firstname.lastname@example.org; or apply at http://www.mayoclinic.org/jobs/physicians-scientists http://www.mayoclinic.org/jobs/physicians-scientists http://www.mayoclinic.org/jobs/physicians-scientists
St. Health Cloud VA Care System Brainerd | Montevideo | Alexandria
Opportunities for full-time and part-time staff are available in the following positions: • Associate Chief of Staff, Primary Care • Dermatologist • Internal Medicine/ Family Practice
• Physician (Compensation & Pension) • Physician (Pain Clinic)/Outpatient Primary Care
• Occupational Health/ • Psychiatrist Compensation & Pension Physician • Radiologist Applicants must be BE/BC.
• Urgent Care
US Citizenship required or candidates must have proper authorization to work in the U.S. Physician applicants should be BE/BE. Education Debt Reduction Program funding may be authorized for the health professional education that was required of the position. Possible recruitment bonus. EEO Employer. Competitive salary and benefits with recruitment/ relocation incentive and performance pay possible.
For more information: Visit www.USAJobs.gov or contact Nola Mattson, STC.HR@VA.GOV Human Resources 4801 Veterans Drive, St. Cloud, MN 56303
(320) 255-6301 February 2016 Minnesota Physician
Speech and language development from page 25
communicative intent, eye gaze, social skills, and other factors that may be related to a diagnosis of autism and is an invaluable member of the team for the medical professional providing the diagnosis. When in doubt, it is best to refer to the SLP for a comprehensive assessment to add value to other interdisciplinary findings. Speech fluency: Parents may express particular concern if they suspect that their child is stuttering. It is important to consider that all young children have certain normal disfluencies in their speech, particularly in the toddler and preschool years as they undergo periods of rapid development. Normal disfluencies are often in the form of phrase repetitions (I want…I want…); revisions (I goed...I went); and interjections (uh, um). Stutter-like disfluencies may more often take the form of repetitions of
sounds (p-p-p-puppy); syllables (bub-bub-bubble) or short words (you-you-you). It is of more concern if the child is distressed by their difficulty speaking, especially if they stop talking (oh, never mind…). If the child exhibits struggle, force, or other body movements associated with their stuttering, they should be referred to an SLP for an evaluation. The SLP
If not addressed early, challenges with language can lead to long-term impacts.
might decide to begin treatment immediately, particularly if the stuttering has been going on for a few months. Or, the SLP may decide to monitor the child for a few months to see if the stuttering subsides on its own.
BEYOND TREATING, THERE’S CARING W E L L A N D BE YO N D Fairview Health Services seeks physicians with an unwavering focus on delivering the best clinical care and a passion for providing outstanding patient experience.
We currently have opportunities in the following areas: • • • • • • • • •
Allergy/Immunology Dermatology Emergency Medicine Family Medicine General Surgery Geriatric Medicine Hospitalist Internal Medicine Med/Peds
Factors that make it more likely for stuttering to persist are: being male; age of onset later in the preschool years; a family history of stuttering (persistent or resolved); and the presence of other speech and language delays. It is typical for children who stutter to go through periods of more and less fluency. It is important to realize that just because the stuttering seems
• • • • • • • • •
Neurology OB/GYN Orthopedic Surgery Pain Medicine Palliative Care Pediatrics Psychiatry Sports Medicine Urology
to have gone away, it does not mean that it might not return. Treatment for stuttering is much more effective in the preschool years than it is later in life.
Conclusion As with any aspect of human development, there is a range of what is considered normal in speech and language acquisition. It is important to allow parents the opportunity to express their concerns while offering reassurance. Parents tend to be accurate reporters regarding what their child can and cannot communicate, even if their level of concern seems higher or lower than a physician’s level of concern. The American Speech-Language-Hearing Association (www.asha.org) offers a wide range of information for parents and professionals who are concerned with the development of children. Mark DeRuiter, PhD; Linda Hinderscheit, MA; and Marilyn Fairchild, MA, are all speech-language pathol-
ogists who work in the Department of Speech-Language-Hearing Sciences at the University of Minnesota, Twin Cities.
Family Medicine & Emergency Medicine Physicians
• Immediate Openings • Casual weekend or evening shift coverage • Set your own hours • Competitive rates • Paid Malpractice
To learn more, visit fairview.org/physicians, call 800-842-6469 or email recruit1@ fairview.org fairview.org/physicians TTY 612- 672-7300 EEO/AA Employer
Sorry, no J1 opportunities.
Minnesota Physician February 2016
763-682-5906 | 763-684-0243 email@example.com www.whitesellmedstaff.com
Sawtooth Mountain Clinic
Together Through Life
a 501(c)(3) not-for-profit organization
Behavioral Behavioral Health Health Consultant Consultant Exciting a team integrating physical and Exciting Opportunity Opportunityto forjoin a Behavioral Health Professional to join emotional health at FQHC. Preferred candidate will have a team integrating behavioral health into primary care at FQHC. experience with SBIRT model & electronic medical records, and Team includes Physicians, Nurse Practitioner, Care Coordinator, be fully committed to a team concept. Team includes Physicians, Dietitian and another Behavioral Health Consultant. Ideal Nurse Practitioner, Case Manager, Dietitian and another candidate would be committed to working in an integrated team Behavioral Healthwith Consultant, to maximize patient and and comfortable EMRs. Licensure in one of thephysical following is mental health in a primary care setting. Licensure in one of the preferred: Graduate Level Social Work, Psychologist, Marriage and following is preferred: Social Work, Psychologist, Marriage and Family Therapist or Psychiatric Certified Nurse Practitioner. Family Therapist or Psychiatric Certified Nurse Practitioner. This This is is an an opportunity opportunity to to be be on on the the cutting cutting edge edge of of behavioral behavioral health care — as well as live on the North Shore in beautiful health care – as well as live on the North Shore in beautiful Grand Grand Marais, Marais, MN! MN!
Job application available on SMC’s website: www.sawtoothmountainclinic.org or at the clinic’s front reception desk. Questions? Contact Sue Nordman at 218-387-2330 ext. 126, or firstname.lastname@example.org
Cuyuna Regional Medical Center is seeking two full-time Family Medicine physicians for its Crosby Clinic. Located in the heart of the Cuyuna Lakes Area, CRMC’s Crosby clinic has recruited 22 New and dedicated, quality physicians & APC’s in the last 2 ½ years that, along with the required up-to-date technology, have developed CRMC into a regional resource for advanced diagnostic and therapeutic healthcare services. Our Family Medicine opportunity: • MD or DO • Board Certified/Eligble in Family Medicine, Internal Medicine or IM/Peds • Full-time position equaling 36 patient contact hours per week • Work 4.5 days a week. • 1 in 11 Peds call. (Majority of calls handled by phone consultation) • Practice supported by 14 FM colleagues, APC’s and over 35 multi-specialty physicians • Subspecialty providers—Internal Medicine, OB/GYN, Orthopedics, Urology, Surgery, Oncology, Pain Management and more • Competitive comp package, generous signing bonus, relocation and full benefits • New Residients are encouraged to apply A physician-led organization, CRMC has grown by more than 40 percent in the past three years and is proudly offering some procedures that are not done elsewhere in the nation. The Medical Center’s unique brand of personalized care is characterized by a record of sustained strength and steady growth reflected by an ever-increasing range of services offered.
The perfect match of career and lifestyle. Affiliated Community Medical Centers is a physician owned multispecialty group with 11 affiliate sites located in western and southwestern Minnesota. ACMC is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. Current opportunities available for BE/BC physicians in the following specialties: • Dermatology • ENT • Family Medicine • Gastroenterology • General Surgery • Geriatrician • Outpatient Internal Medicine
• Hospitalist • Infectious Disease • Internal Medicine • OB/GYN • Oncology • Orthopedic Surgery • Pediatrics
• Psychiatry • Psychology • Pulmonary/ Critical Care • Rheumatology • Sleep Medicine • Urgent Care
F O R M O R E I N F O R M AT I O N :
Kari Lenz, Physician Recruitment | email@example.com | (320) 231-6366 www.acmc.com |
At Essentia Health, we believe in collaborative care that values the perspective of patients and their families. Backed by the resources of a large, integrated health system, our physicians provide quality care across the large and small communities we serve. Open pOsitiOns include: n n n n
Emergency Medicine Geriatrics OB/GYN Urgent Care
n n n n
Family Medicine Internal Medicine Rheumatology Vascular Surgery
800-882-7310 | www.essentiahealth.org/careers
Contact: Todd Bymark, firstname.lastname@example.org (218) 546-3023 | www.cuyunamed.org February 2016 Minnesota Physician
Advanced practice nursing in Minnesota from page 23
are grounds for disciplinary action in another jurisdiction, or would be grounds for disciplinary action after investigation. Licensed new graduate APRNs in the role of CNS and CNP are required to work for 2,080 hours within the context of collaborative management in a hospital or integrated care setting where physicians and APRNs work together. The intent is to allow newly licensed CNSs and CNPs time to become accustomed to referral and consultation patterns when caring for a patient whose conditions are outside the APRN’s scope of practice. Verification of completion of the post graduate practice hours must be completed by a licensed Minnesota physician or APRN and submitted to the Board. Validation of completion of the post graduate practice hours may be found on the APRN Licensure Detail Report
located on the Minnesota Board of Nursing webpage (http:// mn.gov/boards/nursing/public/ aprn-license-verification/). As of Oct. 15, 2015, there are 6,828 APRNs licensed in Minnesota (see Table 1). The Twin Cities and the southern region of Minnesota are the most populous regions of practicing APRNs (see Figure 1). Future trends
Board of Nursing APRN web page at http://mn.gov/boards/ nursing/advanced-practice/ advanced-practice-generalinformation/aprn-generalinformation.jsp
Julie Sabo, PhD(c), APRN, CNS, is
the APRN specialist at the Minnesota Board of Nursing and has been a CNS since 1989.
Table 1. Total number of APRNs by role Type of license
No. of APRNs
Source: Minnesota Board of Nursing
Fig. 1. L icensed APRNs by business address—2nd quarter 2015
In 2013, the Health Resources and Services Administration published the report Projecting the Supply and Demand for Primary Care Practitioners through 2020), and projected a 30 percent increase in the number of CNPs between 2010 and 2020. Clearly, the number of APRNs in Minnesota will increase, although it is too early to see trends in location service areas or populations served by APRNs. For more information on APRN licensing and practice authority, see the Minnesota
Twin Cities Northwest
Northeast West Central
Central Southwest Southern Border states
No business address
Source: Minnesota Board of Nursing
Olmsted Medical Center, a 220-clinician multi-specialty clinic with 10 outlying branch clinics and a 61 bed hospital, continues to experience significant growth. Olmsted Medical Center provides an excellent opportunity to practice quality medicine in a family oriented atmosphere. The Rochester community provides numerous cultural, educational, and recreational opportunities. Olmsted Medical Center offers a competitive salary and comprehensive benefit package.
Opportunities available in the following specialties: Anesthesiologist Hospital
Rochester Southeast Clinic
Family Medicine Rochester Clinics
General Surgery Hospital
OMC Hospital – Women’s Health Pavilion
Rochester Southeast Clinic
Psychiatrist – Child & Adolescence
Rochester Southeast Clinic
Rochester Northwest Clinic
Rochester Southeast Clinic
Send CV to: Olmsted Medical Center Human Resources/Clinician Recruitment 210 Ninth Street SE, Rochester, MN 55904
email: email@example.com • Phone: 507.529.6748 • Fax: 507.529.6622
Minnesota Physician February 2016
Chronic disease spending in Minnesota from page 17
called Healthy Minnesota 2020: Chronic Disease and Injury. This plan establishes 12 objectives built around risk factors with explicit, actionable performance targets in Minnesota for 2020. This plan aims to increase knowledge and skills of the population to live the healthiest possible lives, support patients in receiving the right care at the right time in the right place, and ensure that Minnesotans have the best information about disease, risk factors, and treatment practices. A first step Our report on the economic toll of chronic disease in Minnesota represents the first in a series of reports that will support this important work by using the All-Payer Claims Database to investigate the burden of chronic disease, document opportunities for improving
care, and build the case for greater public health investment. However, it is clearly only a first step. For example, though the report includes cancer costs in the total spending estimates, we were not able to break out cancer costs separately.
Minnesotans, the MN APCD represents a substantial upgrade of our ability to fight chronic disease in Minnesota. With granular, county-level data, we can work toward implementing evidence-based, public health investments in
We particularly need physicians and clinicians to work with MDH.
Given the astounding toll of chronic disease in Minnesota, it is more important than ever to use available data to inform policy options. By bringing together data on patient demographics, diagnosis, and health care spending for nearly all
It’s your life. Live it well.
Family Medicine with or without OB
Our independent, physician-owned clinic is seeking a BC/BE physician (with or without OB) for our clinic. 1:7 Calls. Competitive salary/benefits, with opportunity for ownership within 1 year. Paid malpractice, health and dental insurance, 401(k), CME and more. Cloquet is an historic, vibrant community just 15 minutes from Duluth and 10 minutes from Jay Cooke State Park. Adjacent to the St. Louis River, Cloquet has hiking, biking and ATV trails; skiing; boating; fishing; parks; and the only white water rafting in Minnesota. Residents enjoy locally performed plays, concerts and the arts; community festivals; dining and more.
Send CV to: firstname.lastname@example.org 218.879.1271 ext. 108 • www.raiterclinic.com 417 Skyline Blvd. • Cloquet, MN 55720
different geographies. And with data on what is attainable across Minnesota, we can set goals and measure success and the need for improvement. We particularly need physicians and clinicians to work with MDH and direct MDH
on how we can best use this database moving forward. We want to know what information you need, what questions we should be asking to help you or your organization with practice patterns, treatments, and therapies, and what benchmarks are needed for improvement. I hope that as we sharpen our focus on the burden of chronic disease through the data and analyses afforded by the MN APCD, we will use that understanding to build support for health equity in Minnesota and adopt the most effective strategies for managing and preventing chronic disease.
Edward Ehlinger, MD, MSPH, was appointed by Gov. Mark Dayton in 2011 to serve as the commissioner of the Minnesota Department of Health, the state’s lead public health agency. Commissioner Ehlinger is boardcertified in both internal medicine and pediatrics.
Sioux Falls VA Health Care System Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package. The VAHCS is currently recruiting for the following healthcare positions in the following location.
Sioux Falls VA HCS, SD Cardiologist
Primary Care (Family Practice or Internal Medicine)
ENT (part-time) Emergency Medicine Gastroenterologist Hospitalist
Psychiatrist Pulmonologist Urologist (part-time)
(605) 333-6852 www.siouxfalls.va.gov Applicants can apply online at www.USAJOBS.gov February 2016 Minnesota Physician
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ENTRESTO™ (sacubitril and valsartan) tablets, for oral use Initial U.S. Approval: 2015 BRIEF SUMMARY: Please see package insert for full prescribing information. WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1)
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Minnesota Physician February 2016
In the PARADIGM-HF trial, the incidence of angioedema was 0.1% in both the enalapril and ENTRESTO run-in periods. In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril (0.5% and 0.2%, respectively). The incidence of angioedema in Black patients was 2.4% with ENTRESTO and 0.5% with enalapril [see Warnings and Precautions (5.2)]. Orthostasis was reported in 2.1% of patients treated with ENTRESTO compared to 1.1% of patients treated with enalapril during the double-blind period of PARADIGM-HF. Falls were reported in 1.9% of patients treated with ENTRESTO compared to 1.3% of patients treated with enalapril.
1 INDICATIONS AND USAGE 1.1 Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. ENTRESTO is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB. 4 CONTRAINDICATIONS ENTRESTO is contraindicated: • in patients with hypersensitivity to any component • in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions (5.2)] • with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions (7.1)] • with concomitant use of aliskiren in patients with diabetes [see Drug Interactions (7.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Fetal Toxicity ENTRESTO can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO. However, if there is no appropriate alternative to therapy with drugs affecting the reninangiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus [see Use in Specific Populations (8.1)]. 5.2 Angioedema ENTRESTO may cause angioedema. In the double-blind period of PARADIGM-HF, 0.5% of patients treated with ENTRESTO and 0.2% of patients treated with enalapril had angioedema [see Adverse Reactions (6.1)]. If angioedema occurs, discontinue ENTRESTO immediately, provide appropriate therapy, and monitor for airway compromise. ENTRESTO must not be re-administered. In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/ adrenaline solution 1:1000 (0.3 mL to 0.5 mL) and take measures necessary to ensure maintenance of a patent airway. ENTRESTO has been associated with a higher rate of angioedema in Black than in non-Black patients. Patients with a prior history of angioedema may be at increased risk of angioedema with ENTRESTO [see Adverse Reactions (6.1)]. ENTRESTO should not be used in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy [see Contraindications (4)]. 5.3 Hypotension ENTRESTO lowers blood pressure and may cause symptomatic hypotension. Patients with an activated renin-angiotensin system, such as volumeand/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. In the double-blind period of PARADIGM-HF, 18% of patients treated with ENTRESTO and 12% of patients treated with enalapril reported hypotension as an adverse event [see Adverse Reactions (6.1)], with hypotension reported as a serious adverse event in approximately 1.5% of patients in both treatment arms. Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose. If hypotension occurs, consider dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia). If hypotension persists despite such measures, reduce the dosage or temporarily discontinue ENTRESTO. Permanent discontinuation of therapy is usually not required. 5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO. In the double-blind period of PARADIGM-HF, 5% of patients in both the ENTRESTO and enalapril groups
reported renal failure as an adverse event [see Adverse Reactions (6.1)]. In patients whose renal function depends upon the activity of the reninangiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt ENTRESTO in patients who develop a clinically significant decrease in renal function [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) in the full prescribing information]. As with all drugs that affect the RAAS, ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with renal artery stenosis, monitor renal function. 5.5 Hyperkalemia Through its actions on the RAAS, hyperkalemia may occur with ENTRESTO. In the double-blind period of PARADIGM-HF, 12% of patients treated with ENTRESTO and 14% of patients treated with enalapril reported hyperkalemia as an adverse event [see Adverse Reactions (6.1)]. Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of ENTRESTO may be required [see Dosage and Administration (2.1) in the full prescribing information]. 6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: • Angioedema [see Warnings and Precautions (5.2)] • Hypotension [see Warnings and Precautions (5.3)] • Impaired Renal Function [see Warnings and Precautions (5.4)] • Hyperkalemia [see Warnings and Precautions (5.5)] 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 practice. In the PARADIGM-HF trial, subjects were required to complete sequential enalapril and ENTRESTO run-in periods of (median) 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing ENTRESTO and enalapril. During the enalapril run-in period, 1,102 patients (10.5%) were permanently discontinued from the study, 5.6% because of an adverse event, most commonly renal dysfunction (1.7%), hyperkalemia (1.7%) and hypotension (1.4%). During the ENTRESTO run-in period, an additional 10.4% of patients permanently discontinued treatment, 5.9% because of an adverse event, most commonly renal dysfunction (1.8%), hypotension (1.7%) and hyperkalemia (1.3%). Because of this run-in design, the adverse reaction rates described below are lower than expected in practice. In the double-blind period, safety was evaluated in 4,203 patients treated with ENTRESTO and 4,229 treated with enalapril. In PARADIGM-HF, patients randomized to ENTRESTO received treatment for up to 4.3 years, with a median duration of exposure of 24 months; 3,271 patients were treated for more than one year. Discontinuation of therapy because of an adverse event during the double-blind period occurred in 450 (10.7%) of ENTRESTO treated patients and 516 (12.2%) of patients receiving enalapril. Adverse reactions occurring at an incidence of ≥5% in patients who were treated with ENTRESTO in the double-blind period are shown in Table 1. Table 1: Adverse Reactions Reported in ≥5% of Patients Treated with ENTRESTO in the Double-Blind Period ENTRESTO Enalapril (n = 4,203) (n = 4,229) % % Hypotension 18 12 Hyperkalemia 12 14 Cough 9 13 Dizziness 6 5 Renal failure/acute renal failure 5 5
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© Novartis T2015-100 ENTRESTO is a trademark of Novartis AG Issued: July/2015
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Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
FEBRUARY 2016 Minnesota Physician
in utero exposure to ENTRESTO, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Data Animal Data ENTRESTO treatment during organogenesis resulted in increased embryofetal lethality in rats at doses ≥ 49 mg sacubitril/51 mg valsartan/kg/day (≤ 0.14 [LBQ657, the active metabolite] and 1.5 [valsartan]-fold the maximum recommended human dose [MRHD] of 97/103 mg twice-daily on the basis of the area under the plasma drug concentration-time curve [AUC]) and rabbits at doses ≥ 5 mg sacubitril/5 mg valsartan/kg/day (4-fold and 0.06-fold the MRHD on the basis of valsartan and LBQ657 AUC, respectively). ENTRESTO is teratogenic based on a low incidence of fetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an ENTRESTO dose of ≥ 5 mg sacubitril/5 mg valsartan/kg/day. The adverse embryo-fetal effects of ENTRESTO are attributed to the angiotensin receptor antagonist activity. Pre- and postnatal development studies in rats at sacubitril doses up to 750 mg/kg/day (4.5-fold the MRHD on the basis of LBQ657 AUC) and valsartan at doses up to 600 mg/kg/day (0.86-fold the MRHD on the basis of AUC) indicate that treatment with ENTRESTO during organogenesis, gestation and lactation may affect pup development and survival. 8.2 Lactation Risk Summary There is no information regarding the presence of sacubitril/valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Sacubitril/valsartan is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/ valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO. Data Following an oral dose (15 mg sacubitril/15 mg valsartan/kg) of [14C] ENTRESTO to lactating rats, transfer of LBQ657 into milk was observed. After a single oral administration of 3 mg/kg [14C] valsartan to lactating rats, transfer of valsartan into milk was observed. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use No relevant pharmacokinetic differences have been observed in elderly (≥65 years) or very elderly (≥75 years) patients compared to the overall population [see Clinical Pharmacology (12.3) in the full prescribing information]. 8.6 Hepatic Impairment No dose adjustment is required when administering ENTRESTO to patients with mild hepatic impairment (Child-Pugh A classification). The recommended starting dose in patients with moderate hepatic impairment (Child-Pugh B classification) is 24/26 mg twice daily. The use of ENTRESTO in patients with severe hepatic impairment (Child-Pugh C classification) is not recommended, as no studies have been conducted in these patients [see Dosage and Administration (2.4) in the full prescribing information, Clinical Pharmacology (12.3) in the full prescribing information]. 8.7 Renal Impairment No dose adjustment is required in patients with mild (eGFR 60 to 90 mL/min/1.73 m2) to moderate (eGFR 30 to 60 mL/min/1.73 m2) renal impairment. The recommended starting dose in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) is 24/26 mg twice daily [see Dosage and Administration (2.3) in the full prescribing information, Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) in the full prescribing information]. 10 OVERDOSAGE Limited data are available with regard to overdosage in human subjects with ENTRESTO. In healthy volunteers, a single dose of ENTRESTO 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of ENTRESTO. Symptomatic treatment should be provided. ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.
Laboratory Abnormalities Hemoglobin and Hematocrit Decreases in hemoglobin/hematocrit of >20% were observed in approximately 5% of both ENTRESTO- and enalapril-treated patients in the doubleblind period in PARADIGM-HF. Serum Creatinine Increases in serum creatinine of >50% were observed in 1.4% of patients in the enalapril run-in period and 2.2% of patients in the ENTRESTO run-in period. During the double-blind period, approximately 16% of both ENTRESTO- and enalapril-treated patients had increases in serum creatinine of >50%. Serum Potassium Potassium concentrations >5.5 mEq/L were observed in approximately 4% of patients in both the enalapril and ENTRESTO run-in periods. During the double-blind period, approximately 16% of both ENTRESTO- and enalapriltreated patients had potassium concentrations >5.5 mEq/L. 7 DRUG INTERACTIONS 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications (4)]. Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan. The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications (4)]. Avoid use with aliskiren in patients with renal impairment (eGFR <60 mL/min/1.73 m²). 7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)]. 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically. 7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary ENTRESTO can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. In animal reproduction studies, ENTRESTO treatment during organogenesis resulted in increased embryofetal lethality in rats and rabbits and teratogenicity in rabbits. When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO. However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. Clinical Considerations Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the reninangiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates with histories of in utero exposure to ENTRESTO for hypotension, oliguria, and hyperkalemia. In neonates with a history of
Use ENTRESTO™ in place of ACEis and ARBs for HFrEF patients1 ENTRESTO was studied in the largest HF trial ever conducted2 • Trial stopped early due to ﬁnding of signiﬁcantly reduced risk of CV death and the primary end point being met3
ENTRESTO has been proven superior to enalapril, a current standard-of-care4 medication1 • Superiority vs enalapril, a standard-of-care ACEi therapy, across a range of NYHA class II–IV patients with chronic HF and reduced ejection fraction REDUCED RISK OF CV DEATH OR FIRST HF HOSPITALIZATION VS ENALAPRIL1 P<0.0001
ABSOLUTE RISK REDUCTION1
HR (95% CI): 0.80 (0.73, 0.87)
REDEFINE EXPECTATIONS IN HEART FAILURE
INDICATION ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. ENTRESTO is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.
IMPORTANT SAFETY INFORMATION WARNING: FETAL TOXICITY
• When pregnancy is detected, discontinue ENTRESTO as soon as possible • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ENTRESTO is contraindicated in patients with hypersensitivity to any component. ENTRESTO is contraindicated in patients with a history of angioedema related to previous angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy. ENTRESTO is contraindicated with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor. ENTRESTO is contraindicated with concomitant use of aliskiren in patients with diabetes. Angioedema: ENTRESTO may cause angioedema. Angioedema associated with laryngeal edema may be fatal. ENTRESTO has been associated with a higher rate of angioedema in Black patients and in patients with a prior history of angioedema. If angioedema occurs, discontinue ENTRESTO immediately, provide appropriate therapy, and monitor for airway compromise. ENTRESTO must not be re-administered. Hypotension: ENTRESTO lowers blood pressure and may cause symptomatic hypotension. Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose. If hypotension persists despite dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia) reduce the dosage or temporarily discontinue ENTRESTO. Permanent discontinuation of therapy is usually not required. Impaired Renal Function: Decreases in renal function may be anticipated in susceptible individuals treated with ENTRESTO. In patients whose renal function depends upon the activity of the reninangiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt ENTRESTO in patients who develop a clinically signiﬁcant decrease in renal function. ENTRESTO may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with renal artery stenosis, monitor renal function. Avoid use with aliskiren in patients with renal impairment (eGFR <60 mL/min/1.73 m2). In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, concomitant use of non-steroidal anti-inﬂammatory drugs (NSAIDs), including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure.
These effects are usually reversible. Monitor renal function periodically. Hyperkalemia: Hyperkalemia may occur with ENTRESTO. Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of ENTRESTO may be required. Concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium. ARBs: Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan. Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO. Common Adverse Events: In a clinical trial, the most commonly observed adverse events with ENTRESTO vs enalapril, occurring at a frequency of at least 5% in either group, were hypotension (18%, 12%), hyperkalemia (12%, 14%), cough (9%, 13%) dizziness (6%, 5%) and renal failure/acute renal failure (5%, 5%). Please see Brief Summary of Prescribing Information, including Boxed WARNING, on following pages. STUDY DESIGN: PARADIGM-HF was a multinational, randomized, double-blind trial comparing ENTRESTO to enalapril in 8442 symptomatic (NYHA class II–IV) adult HFrEF patients (left ventricular ejection fraction ≤40%). After discontinuing their existing ACEi or ARB therapy, patients entered sequential single-blind run-in periods during which they received enalapril 10 mg twice daily, followed by ENTRESTO 100 mg (49/51 mg) twice daily, increasing to 200 mg (97/103 mg) twice daily. Patients were then randomized to receive either ENTRESTO 200 mg (97/103 mg) (n=4209) twice daily or enalapril 10 mg (n=4233) twice daily. The median follow-up duration was 27 months, and patients were treated for up to 4.3 years. The primary end point was the ﬁrst event in the composite of CV death or ﬁrst HF hospitalization.1 ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin II receptor blocker; HFrEF=heart failure with reduced ejection fraction; CV=cardiovascular; NYHA=New York Heart Association; HF=heart failure.
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References: 1. ENTRESTO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; August 2015. 2. McMurray JJV, Packer M, Desai AS, et al. Baseline characteristics and treatment of patients in Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail. 2014;16(7):817-825. 3. McMurray JJV, Packer M, Desai AS, et al. Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371(11):993-1004. 4. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128(16):e240-e327. ENTRESTO is a trademark of Novartis AG.
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