minnesota physician april 2015

My colleagues at Park Dental and I see dozens of patients every day. While our focus is

on their mouths, we occasionally en-counter other health-related issues that require the attention of a physician. Our dentists and hygienists routinely take each patient’s blood pressure, per-form oral cancer screenings, and look for any other symptoms that might be indicative of a larger health issue. If we

encounter any concerning medical is-sues our dentists instruct their patients to visit their physicians.

One of our dentists, Joseph F. Rinaldi III, DDS, recently shared a story with me about just such an oc-currence. Dr. Rinaldi was scheduled to remove a patient’s molar. Prior to the surgery, the patient’s blood pressure

Leveraging information technology to page 18

Forging new alliances to page 16

Vo lum e x x Ix , N o. 1A p r i l 2015

Electronic health record (EHR) sys-tems have become commonplace in Minnesota’s health care sys-

tem, with most clinics and all hospitals transitioning from paper charts to EHRs. Despite this high adoption rate, provid-ers are struggling to optimize the tools and capabilities to support patient care, and to exchange clinical health informa-tion with providers outside of their own health system.

In 2007, the Minnesota Legislature passed the 2015 Interoperable EHR Mandate, which states that all hospitals and health care providers must use an interoperable electronic health record (EHR) system by Jan. 1, 2015 (Minne- sota Statute § 62J.495 Electronic Health Record Technology). An important com-ponent of this law is that providers not only adopt the technology, but that they use the tools available in their EHRs and securely exchange relevant health infor-

Leveraging information technologyA look at EHR data

By Bob Johnson, MPP, and Karen Soderberg, MS

Forging new

The benefits of medical/dental collaboration

By John E. Gulon, DDS

alliances

P ost-acute rehabilitation services from the Good Samaritan Society.

Post-acute care is designed to heal and assist patients with care and support following a hospitalization from serious illness, injury or elective surgical procedure. Multiple in-patient and out-patient post-acute locations are located throughout the Twin Cities metro area and state of Minnesota.

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race, color, religion, gender, disability, familial status, national origin or other protected statuses according to applicable federal, state or local laws. Some services may be provided by a third party. All faiths or beliefs are welcome. © 2015 The Evangelical Lutheran Good Samaritan Society. All rights reserved. 15-G0066

To learn more about our post-acute services, call us at 866-GSSCARE or visit www.good-sam.com/minnesota.

An approach to consider for type 2 diabetes therapy starts here

WARNING: RISK OF THYROID C-CELL TUMORSIn 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 could not be determined from clinical or nonclinical studies.

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). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.

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 mellitus.

Limitations of Use: Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. 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.

Please see Important Safety Information for Trulicity, including Boxed Warning about possible thyroid tumors including thyroid cancer, and Brief Summary of Prescribing Information on following pages. Please see Instructions for Use included with the pen.

Select Important Safety Information

031252_eldhcp_DG95134_jrl_ad_mpp_fa.indd 1 3/23/15 12:26 PM

April 2015 Minnesota Physician 3

*In clinical trials, 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.1

Trulicity may be a good option for adult patients with type 2 diabetes who need more control than oral medications are providing.1

To learn more about Trulicity and the savings card for patients, talk to your Lilly sales representativeor visit Trulicity.com.

DG95134 02/2015 PRINTED IN USA ©Lilly USA, LLC 2015. All rights reserved.

Important Safety Information

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 mellitus.

Limitations of Use: Not recommended as fi rst-line therapy for patients inadequately controlled on diet and exercise. 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.

Trulicity™ offers proven A1C reduction* and once-weekly dosing in the Trulicity pen1

WARNING: RISK OF THYROID C-CELL TUMORSIn 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 could not be determined from clinical or nonclinical studies.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). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.

Trulicity is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

Risk of Thyroid C-cell Tumors: Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Patients with elevated serum calcitonin (if measured) and patients with thyroid nodules noted on physical examination or neck imaging should be referred to an endocrinologist for further evaluation.

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 confi rmed. Consider other antidiabetic therapy in patients with a history of pancreatitis.

Please see Important Safety Information continued on following page.


Data represent least-squares mean ± standard error.

*Multiplicity-adjusted 1-sided P value <.025 for superiority of Trulicity vs Byetta for A1C.†Multiplicity-adjusted 1-sided P value <.001 for superiority of Trulicity vs placebo for A1C. Mixed model repeated measures analysis.

After 26 weeks, placebo-treated patients were switched in a blinded fashion to Trulicity 1.5 mg or Trulicity 0.75 mg.‡American Diabetes Association recommended target goal. Treatment should be individualized.4

Byetta® (10 mcg BID)(n=276; Baseline A1C: 8.1%)

Trulicity™ (0.75 mg) (n=280; Baseline A1C: 8.1%)


Placebo(n=141; Baseline A1C: 8.1%)

• 52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos (up to 45 mg/day)

• Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided P value <.001; analysis of covariance using last observation carried forward); primary objective met

References

1. Trulicity [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2014.

2. Data on file, Lilly USA, LLC. TRU20140910A.

3. Data on file, Lilly USA, LLC. TRU20140919C.

4. American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care. 2014;37(Suppl 1):S14-S80.

A1C reduction from baseline1-3

6.2

6.4

6.6

6.8

7.0

7.2

7.4

7.6

7.8

8.0

8.4

8.2

Week 13 Week 26Baseline

LS m

ean

A1C

(%)

-1.3*†

‡

-1.5*†

-1.0

-0.5

93% fewerinjections3

LS m

ean A

1C (%

)

Once-weekly Trulicity 1.5 mg showed signifi cant A1C reduction1

Important Safety Information,continued

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 clinical trials in patients receiving Trulicity. 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.

The most common adverse reactions reported in ≥5% of Trulicity-treated patients in placebo-controlled trials (placebo, Trulicity 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 benefi t 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 12NOV2014

Trulicity™ is a trademark of Eli Lilly and Company and is available by prescription only.

Other product/company names mentioned herein are the trademarks of their respective owners.

• 52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos® (up to 45 mg/day)

• Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity- adjusted 1-sided P value <.001; analysis of covariance using last observation carried forward); primary objective met

References


2. Data on file, Lilly USA, LLC. TRU20140910A.3. Data on file, Lilly USA, LLC. TRU20140919C.4. American Diabetes Association. Standards

of medical care in diabetes—2014. Diabetes Care. 2014;37(Suppl 1):S14-S80.

Data represent least-squares mean ± standard error.* Multiplicity-adjusted 1-sided P value <.025 for superiority of Trulicity vs Byetta for A1C. † Multiplicity-adjusted 1-sided P value <.001 for superiority of Trulicity vs placebo for A1C.

Mixed model repeated measures analysis. After 26 weeks, placebo-treated patients were switched in a blinded fashion to Trulicity 1.5

mg or Trulicity 0.75 mg. ‡ American Diabetes Association recommended target goal. Treatment should be

individualized.4

Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control.


Placebo (n=141; Baseline A1C: 8.1%)

Byetta® (10 mcg BID) (n=276; Baseline A1C: 8.1%)




4 Minnesota Physician April 2015

*In clinical trials, 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.1

Trulicity may be a good option for adult patients with type 2 diabetes who need more control than oral medications are providing.1

To learn more about Trulicity and the savings card for patients, talk to your Lilly sales representativeor visit Trulicity.com.

DG95134 02/2015 PRINTED IN USA ©Lilly USA, LLC 2015. All rights reserved.

Important Safety Information

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 mellitus.

Limitations of Use: Not recommended as fi rst-line therapy for patients inadequately controlled on diet and exercise. 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.

Trulicity™ offers proven A1C reduction* and once-weekly dosing in the Trulicity pen1

WARNING: RISK OF THYROID C-CELL TUMORSIn 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 could not be determined from clinical or nonclinical studies.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). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.

Trulicity is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or any of the product components.

Risk of Thyroid C-cell Tumors: Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Patients with elevated serum calcitonin (if measured) and patients with thyroid nodules noted on physical examination or neck imaging should be referred to an endocrinologist for further evaluation.

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 confi rmed. Consider other antidiabetic therapy in patients with a history of pancreatitis.

Please see Important Safety Information continued on following page.


Data represent least-squares mean ± standard error.

*Multiplicity-adjusted 1-sided P value <.025 for superiority of Trulicity vs Byetta for A1C.†Multiplicity-adjusted 1-sided P value <.001 for superiority of Trulicity vs placebo for A1C. Mixed model repeated measures analysis.

After 26 weeks, placebo-treated patients were switched in a blinded fashion to Trulicity 1.5 mg or Trulicity 0.75 mg.‡American Diabetes Association recommended target goal. Treatment should be individualized.4

Byetta® (10 mcg BID)(n=276; Baseline A1C: 8.1%)



Placebo(n=141; Baseline A1C: 8.1%)

• 52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos (up to 45 mg/day)

• Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity-adjusted 1-sided P value <.001; analysis of covariance using last observation carried forward); primary objective met

References


2. Data on file, Lilly USA, LLC. TRU20140910A.

3. Data on file, Lilly USA, LLC. TRU20140919C.

4. American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care. 2014;37(Suppl 1):S14-S80.


6.2

6.4

6.6

6.8

7.0

7.2

7.4

7.6

7.8

8.0

8.4

8.2

Week 13 Week 26Baseline

LS m

ean

A1C

(%)

-1.3*†

‡

-1.5*†

-1.0

-0.5

93% fewerinjections3

LS m

ean A

1C (%

)

Once-weekly Trulicity 1.5 mg showed signifi cant A1C reduction1

Important Safety Information,continued

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 clinical trials in patients receiving Trulicity. 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.

The most common adverse reactions reported in ≥5% of Trulicity-treated patients in placebo-controlled trials (placebo, Trulicity 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 benefi t 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 12NOV2014

Trulicity™ is a trademark of Eli Lilly and Company and is available by prescription only.

Other product/company names mentioned herein are the trademarks of their respective owners.

• 52-week, randomized, placebo-controlled phase 3 study (open-label assignment to Byetta or blinded assignment to Trulicity or placebo) of adult patients with type 2 diabetes treated with maximally tolerated metformin (≥1500 mg/day) and Actos® (up to 45 mg/day)

• Primary objective was to demonstrate superiority of Trulicity 1.5 mg vs placebo on change in A1C from baseline at 26 weeks (-1.5% vs -0.5%, respectively; difference of -1.1%; 95% CI [-1.2, -0.9]; multiplicity- adjusted 1-sided P value <.001; analysis of covariance using last observation carried forward); primary objective met

References


2. Data on file, Lilly USA, LLC. TRU20140910A.3. Data on file, Lilly USA, LLC. TRU20140919C.4. American Diabetes Association. Standards

of medical care in diabetes—2014. Diabetes Care. 2014;37(Suppl 1):S14-S80.

Data represent least-squares mean ± standard error.* Multiplicity-adjusted 1-sided P value <.025 for superiority of Trulicity vs Byetta for A1C. † Multiplicity-adjusted 1-sided P value <.001 for superiority of Trulicity vs placebo for A1C.

Mixed model repeated measures analysis. After 26 weeks, placebo-treated patients were switched in a blinded fashion to Trulicity 1.5

mg or Trulicity 0.75 mg. ‡ American Diabetes Association recommended target goal. Treatment should be

individualized.4

Recommended starting dose is 0.75 mg. Dose can be increased to 1.5 mg for additional glycemic control.


Placebo (n=141; Baseline A1C: 8.1%)

Byetta® (10 mcg BID) (n=276; Baseline A1C: 8.1%)





Trulicity DG HCP BS 12NOV2014 Brief Summary 7 x 9.75 PRINTER VERSION 1 OF 2

TrulicityTM (dulaglutide) DG HCP BS 12NOV2014 TrulicityTM (dulaglutide) DG HCP BS 12NOV2014

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 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 could not be determined from clinical or nonclinical studies.• 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). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.

INDICATIONS AND USAGE Trulicity™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise. 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.CONTRAINDICATIONSDo 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 PRECAUTIONSRisk 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. 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 medullary thyroid carcinoma (MTC), in humans, as the human relevance of this signal could not be determined from the clinical or nonclinical studies. 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). Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the 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). The role of serum calcitonin monitoring or thyroid ultrasound monitoring for the purpose of early detection of MTC in patients treated with Trulicity is unknown. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin as a screening test for MTC and a high background incidence of thyroid disease. Very 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 referred to an endocrinologist for further evaluation. Patients with thyroid nodules noted on physical examination or neck imaging should also be referred to an endocrinologist for further evaluation. 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 insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia. 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 REACTIONSClinical 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 43% 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 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 patient 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 patient 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%) TRULICITY-treated 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 placebo-treated patients had mean increases of up to 3%. DRUG INTERACTIONSTrulicity 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 POPULATIONSPregnancy - 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%) Trulicity-treated 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). 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 non-severe 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 is unknown. 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, Eli Lilly and Company. All rights reserved.

Additional information can be found at www.trulicity.com

DG HCP BS 12NOV2014





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 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 could not be determined from clinical or nonclinical studies.• 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). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Counsel regarding the risk factors and symptoms of thyroid tumors.

INDICATIONS AND USAGE Trulicity™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise. 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.CONTRAINDICATIONSDo 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 PRECAUTIONSRisk 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. 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 medullary thyroid carcinoma (MTC), in humans, as the human relevance of this signal could not be determined from the clinical or nonclinical studies. 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). Trulicity is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the 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). The role of serum calcitonin monitoring or thyroid ultrasound monitoring for the purpose of early detection of MTC in patients treated with Trulicity is unknown. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin as a screening test for MTC and a high background incidence of thyroid disease. Very 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 referred to an endocrinologist for further evaluation. Patients with thyroid nodules noted on physical examination or neck imaging should also be referred to an endocrinologist for further evaluation. 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 insulin secretagogues (eg, sulfonylureas) or insulin. Patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia. 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 REACTIONSClinical 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 43% 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 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 patient 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 patient 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%) TRULICITY-treated 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 placebo-treated patients had mean increases of up to 3%. DRUG INTERACTIONSTrulicity 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 POPULATIONSPregnancy - 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%) Trulicity-treated 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). 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 non-severe 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 is unknown. 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, Eli Lilly and Company. All rights reserved.

Additional information can be found at www.trulicity.com

DG HCP BS 12NOV2014




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Features


April 2015 • Volume XXiX, No. 1

www.mppub.com

Publisher Mike Starnes | [email protected]

editor Lisa McGowan | [email protected]

AssociAte editor Richard Ericson | [email protected]

AssistAnt editor Patricia Mata | [email protected]

Art director Alice Savitski | [email protected]

office AdministrAtor Amanda Marlow | [email protected]

Account executive Stacey Bush | [email protected]

DepArTmeNTS

profeSSioNAl upDATe: GeNeTicS

cApSuleS 10

meDicuS 13

iNTerVieW 14

prAcTice mANAGemeNT 20Wilderness HealthBy Cassandra Beardsley

WomeN’S HeAlTH 22EndometriosisBy Matthew Palmer, DO

AllieD profeSSioNS 26Unionizing home health careBy Sumer Spika

NeuroloGy 28Vision and mild traumatic brain injuryBy Jessica Schara, OD

Matt Brandt

Multicare Associates

Forging new alliances 1The benefits of medical/dental collaborationBy John E. Gulon, DDS

Leveraging information technology 1A look at EHR dataBy Bob Johnson, MPP, and

Karen Soderberg, MS

Pharmacogenetics 24By Ken Dornfeld, MD, PhD, and Catherine A. McCarty, PhD, MPH

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 [email protected]. 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 re-place 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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capsules


Shared Decision Making Studied in Cancer Screening allina health, Virginia com-monwealth University, and the communities of Buffalo and hastings have concluded a three-year study on colorectal cancer screening called colorectal can-cer screening With improved shared Decision Making (cRcs-WisDM). the partnership’s goal was to determine whether using educational materials to address patients’ concerns, questions, and preferences about screening options would improve adher-ence to colorectal cancer screen-ing guidelines.

through the Blue cross and Blue shield of Minnesota-funded study, known as the “Don’t Fear the Rear” project, researchers offered patients information about two colorectal cancer screening methods—fecal occult blood test and colonoscopy. allina health patients aged 50

to 75 years who were at average risk for colorectal cancer were eligible to participate. Research-ers also worked to engage the general public through infor-mational campaigns at com-munity events. they developed an award-winning website with general screening information and updates to help engage and educate the public.

More than 3,500 patients who were not up to date with their screening were eligible for the study. of those, more than 2,500 had colorectal cancer screening tests ordered and more than 100 engaged in shared decision- making sessions with a nurse.

according to allina health, one study participant said, “the WisDM project prompted me to get a screening and a precan-cerous polyp was removed. so i’m very grateful to the people who put this project together.” Researchers plan to continue analyzing data and will re-lease findings over the coming months. however, they say that

preliminary results from a com-munity-wide questionnaire show that most people prefer making decisions about their health care with their provider, versus making decisions on their own or leaving decisions solely up to their doctor.

“We know that offering choices to our patients can be a powerful strategy to engage in patient-centered care,” said tim-othy sielaff, MD, chief medical officer at allina health. “allina is committed to this strategy and to empowering patients to make informed health care decisions.”

Workplace Solutions For Physician Burnout Studiedaddressing communication and workflow issues at hospitals may help reduce rates of physician burnout and dissatisfaction and improve retention rates, ac-cording to a national study led

by hennepin county Medical center (hcMc).

“With more new patients accessing health care systems, we need every clinician possi-ble to be motivated, connected, and functioning at their best,” said Mark Linzer, MD, director of hcMc’s Division of General internal Medicine. “the loss of clinicians to organizations at this point in time can indeed be a disaster.”

Primary care clinicians at 34 clinics in the upper Midwest and new york city participated in the study. half the clinics were randomized to work-life interventions and half received no interventions. Researchers then measured work conditions, including time pressure, work-place chaos, and work control, as well as clinician outcomes, at a baseline and at 12 to 18 months. of 166 clinicians, 135 completed the study.

the results show that at the clinics with interventions, physician burnout or satisfaction


was 3.5 to 5.9 times more likely to improve than those where no changes took place. specifically, those with interventions saw a 21.8 percent reduction in burn-out rates, compared to a 7.1 per-cent reduction among the group with no interventions, and a 23.1 percent increase in satisfaction rates, compared to a 10 percent increase among the group with no interventions.

the study identified three types of interventional programs that were most effective—work-flow redesign, communication improvements (particularly between provider groups), and quality improvement projects targeted to clinician concerns. specifically, the communica-tions and workflow interventions showed a trend toward greater improvements in clinician satis-faction and retention rates.

“these are people who chose medicine because they wanted to help others, and now they are the ones who need support,” said Linzer. “Given that need, we focused on interventions that might improve clinicians’ work-life balance or their experiences at work. this study shows that interventions can have a positive effect on clinicians; and the next step in the analyses will deter-mine how much of this impact is transmitted to patients.”

Linzer and his team are now taking these data and interven-tions to hospitals across the U.s. through collaborations with the american Medical association.

State Hospitals Report Adverse Health Eventsthe number of deaths due to hospital errors decreased last year, according to the Minnesota Department of health’s (MDh) 11th annual adverse health events report.

the report includes data from 69 Minnesota hospitals and surgical centers from oc-tober 2013 to october 2014. in that time period, they reported 2 million visits in which there were 308 adverse health events, including 98 serious injuries and 13 deaths. in the previous report,

which tallied data from october 2012 to october 2013, there were 258 adverse health events, 84 serious injuries, and 15 deaths recorded. the authors point out that four new reportable event categories were added this year and those additions contributed to the rise in reportable errors.

the new categories were death or serious injury result-ing from failure to follow up or communicate laboratory, pathol-ogy, or radiology test results (in which five events were reported); irretrievable loss of an irre-placeable biological specimen (in which 20 events were report-ed); neonatal death or serious injury associated with labor and delivery in a low-risk pregnancy (in which six events were report-ed); and death or serious injury of a patient associated with the introduction of a metallic object into the MRi area (in which no events were reported).

“the adverse events reporting system provides a strong system for learning and improvement,” said Lawrence Massa, presi-dent and ceo of the Minnesota hospital association. “in the 15 years that Minnesota’s hospitals have been spearheading patient safety efforts, they have shown a remarkable commitment to improving patient safety and the addition of these new events demonstrates that commitment to continuous improvement.”

the top reported events included 107 pressure ulcers, 79 falls associated with serious injury or death, and 33 events in which foreign objects were left in patients after surgery.

MDh’s goals for improvement in 2015 include testing devel-oping strategies to reduce lost specimens; improving commu-nications regarding patients’ test results; more effectively identi-fying fragments or lost instru-ments to ensure they are not left in patients during surgery or invasive procedures; improving perinatal safety; and partnering with surgeons and interventional radiologists to improve correct spine level surgery and spinal injections.

according to MDh, Minne- sota is one of 28 states that tracks adverse events and only

Capsules to page 12

LIVE AT ORCHESTRA HALL

The 5 BrownsFri May 15 8pmWhen The 5 Browns sit at their 5 Steinways and play arrangements from Gershwin to Rachmaninoff, you won’t believe your ears. No wonder the famed Juilliard School admitted them all—simultaneously. Please note: The Minnesota Orchestra does not perform on this program.

Garrick Ohlsson Plays BrahmsThu May 21 11am / Fri May 22 & Sat May 23 8pm Stanislaw Skrowaczewski, conductor / Garrick Ohlsson, piano

The extraordinary Garrick Ohlsson plays the youthful and vigorous Piano Concerto No. 1 by Brahms; this exhilarating program concludes with Beethoven’s dance-infused Symphony No. 7.

André Watts with Osmo VänskäThu May 28 11am / Fri May 29 & Sat May 30 8pm Osmo Vänskä, conductor / André Watts, piano

Brahms called his Piano Concerto No. 2, “a tiny, tiny, pianoforte concerto" but it is anything but that, especially when played by the legendary André Watts. Then Osmo Vänskä brings his inimitable touch to Sibelius Symphony No. 3.

Singin’ in the Rain* Film with the Minnesota OrchestraThu Jul 9 11am / Fri Jul 10 8pmSarah Hicks, conductor

Short of dancing down a rain-splattered street, there’s no better way to recapture the magic of this classic MGM musical than to see it on a big screen with a live orchestra performing songs from the timeless soundtrack.

Media Partner:PHOTOS Watts: Steve J. Sherman, The 5 Browns: Bryan Hernandez-Luch, Ohlsson: Paul Body

All programs, artists, dates, times and prices subject to change.

ANDRÉ WATTSGARRICK OHLSSON

THE 5 BROWNS

minnesotaorchestra.org 612.371.5656 / Orchestra Hall


two others report the results publicly—new hampshire and colorado.

Home Visit Program To Reduce Hospital ReadmissionsRegions hospital and the st. Paul Fire Department have teamed up to help reduce emer-gency calls and unnecessary hos-pital readmissions in the east Metro through a pilot program where specially trained para-medics will visit patients in their homes within 48 hours after they are discharged from the hospital. Readmissions usually happen within the first 72 hours of being released. the program will focus on patients with congestive heart failure, which has one of the highest hospital readmission rates. Patients will be referred to the st. Paul Fire Department for a free commun-

ity paramedic home visit as part of the discharge process when they leave the hospital.

Paramedics will provide education on medications, per-form a clinical assessment, help patients understand symptoms to watch for, make sure they are connected to resources within the community for food and transportation, and perform a home safety check.

“so much of what keeps people healthy happens outside of the doctor’s office,” said R.J. Frascone, MD, medical director of Regions hospital emergency Medical services. “innovative programs and partnerships, such as this, help us as a community find new ways to improve health. our colleagues at Methodist hospital have seen great results with this program, and we are excited to expand it to the east Metro.”

Methodist hospital launched the program in May 2014. Para-medics have visited almost 200 patients and found 20 cases that

needed additional medical care. they also referred 10 patients to social and community services, seven patients to food shelves, and replaced smoke detectors or batteries in 52 homes.

Patient Safety Bill Introduced in Minnesota HouseRep. Joe atkins (DFL-inver Grove heights) has authored a bill related to patient safety that was introduced in the Minne-sota house of Representatives on March 9. the safe Patient standard bill would establish a workgroup to determine min-imum staffing for nurses for various hospital units and sizes in Minnesota.

the Minnesota nurses association (Mna) is a strong proponent of the bill. “Frontline nurses are worried about their patients,” said Linda hamilton, Rn, president of the Minne- sota nurses association. “they

know patients are ringing their call lights. they know patients are waiting or they’re not being assessed properly. We’re not delivering the safe, quality care that Minnesotans expect and deserve.”

the Minnesota hospital association (Mha) opposes the bill, saying that legislation should not determine levels of hospital staffing. “the condition of the patient, the experience of the care team, and the mix of the care team has as much to do with patient outcomes—if not more—as the number of nurses,” said Wendy Burt, spokesperson for Mha. “staffing should be based on the patient, the severity of the patient’s illness, the whole care team required to care for that patient, and the experience and education of the care team members. staffing should be flexible. health care profession-als closest to the patient should determine appropriate levels of staffing, not the government.”

Capsules from page 11

Tell them there’s a better way!Get your patients

screened for colorectal cancer.

Ezgi Tiryaki, MD

John Ryden, MD

Mark Hauge, MD

Virginia Miller, PhD


Medicus

Mothilal Sonia Jain, MD, board-certified in cardiovascular disease and internal medicine, has joined the cardiology team at olmsted Medical center, Rochester. Jain earned her medical degree at Kas-turba Medical college, india, and completed a residency in internal medicine as well as a fellowship in advanced echocardiography and cardiovascular diseases at Mayo clinic, Rochester. Previously, Jain was a clinical and research fellow in cardiology and earned her residency in internal medicine at University hospitals, coventry and Warwickshire nhs trust, U.K.

Ezgi Tiryaki, MD, medical director of the aLs center for excellence at hennepin county Medi-cal center and associate chief of staff for educa-tion for the Minneapolis Va health care system, has received the University of Minnesota’s Grad-uate and Professional Distinguished teaching award for being the top instructor at the medi-cal school. the award recognizes excellence in instruction, program development, advising, and mentoring, as well as involvement in students’ research, scholarship, and professional development. tiryaki also serves as an associate professor in the department of neurology at the University of Minnesota and is one of 11 faculty advisors for medical school students. she earned her medical degree from han-nover Medical school, Germany.

John Ryden, MD, board certified by the ameri-can Board of Family Medicine, has joined Du- luth-based st. Luke’s Laurentian Medical clinic in Mountain iron. Ryden earned his medical degree at Mayo Medical school, Rochester; com-pleted a residency in family medicine at David Grant UsaF Medical center, Fairfield, calif., and was previously named Physician of the year by Lake superior Medical society. Ryden has over 20 years’ experience as a family practi-tioner. Most recently, he served as a family practitioner at essentia health–Lakeside clinic, Duluth, and as an urgent care physician for Bloomington-based healthPartners.

Mark Hauge, MD, medical oncologist at coborn cancer center in st. cloud, has received the st. cloud hospital Physician of excellence award. the award recognizes a st. cloud hospital med-ical staff member for exemplary work ethic and dedication to patient care. Winners are nominat-ed by their peers; those who nominated hauge characterized him as respectful, dedicated, and always willing to put his patients first. hauge earned his medical degree from Mayo Medical school, Rochester; completed a fellowship in

medical oncology at Mayo clinic, Rochester; and completed a resi-dency in internal medicine at the University of Minnesota.

Virginia Miller, PhD, director of the Women’s health Research center at Mayo clinic and professor of surgery and physiology at the Mayo clinic college of Medicine, has received the Woman’s Day Red Dress award for her contribu-tions to fighting heart disease. Miller’s research has focused on how sex hormones affect the blood vessels and heart in women and men, as well as other gender differences in cardiovascu-lar health. Miller earned her PhD in physiology at the University of Missouri, columbia, and completed her postdoctoral fellowship at the Uni-versity of Virginia. she also serves as the principal investigator for Mayo clinic’s specialized center of Research on sex Differences and the research director for Mayo clinic’s Building interdisciplin-ary Research careers in Women’s health training program. she was the principal investigator for the Mayo site of the multicenter clinical trial, Kronos early estrogen Prevention study (KeePs).

MINNESOTA HEALTH CARE ROUNDTABLE

Please mail, call in, or fax your registration by 4/20/2015

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.

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Background and Focus: With dramatic population growth, and as baby boomers become senior citizens, the demand for health care is exceeding the supply. Addressing the shortage of medical doctors involves creating new relationships between medical professionals. Training and licensure for Physician Assistants, Advanced Nurse Practitioners, Chiropractors, Respiratory Therapists, Physical Therapists, Home Care Providers, Dentists, and many other health care professions have become increasingly rigorous and provide expanded support to our health-care delivery system. Greater integration of these professions allows medical doctors to work to the top of their license but requires new pathways for communication and care coordination.

Objectives: We will examine many of the new partnerships that are emerging between medical doctors and other medical professionals. We will look at the ways leveraging these new relationships can improve access to care while reducing costs and improving outcomes. We will consider points of resistance to forming these kinds of health care teams and what should be avoided in creating them. We will discuss what the proper oversight for these relationships should entail and how to maximize the coordination of care that they require.

Panelists Include:•Mehul Desai, MD, Minneapolis Advanced Pain Specialists•Michael Hu, MD, Vascular Surgeon, Hennepin County Medical Center•Derek Hustvet, RRT-NPS, LRT, Director of Respiratory Service,

Pediatric Home Service• John Gulon, DDS, President of Park Dental•Craig Johnson, PT, MBA, President MNPTA, Director of Clinical

Integration Therapy Partners•Chuck Sawyer, DC, Senior Vice President, Northwestern Health

Sciences University•Gary Wingrove, Paramedic (ret), The Paramedic Foundation

Sponsors Include: Minneapolis Advanced Pain Specialists, Park Dental, and Pediatric Home Service

Expanding medical professional relationships

Thursday April 23, 2015, 1:00-4:00 PM

Downtown Minneapolis Hilton and Towers

The New Face of Health Care

PrimaCare Direct: A health care cooperative

Matt Brandt

Multicare Associates

Mr. Brandt is CEO of Multicare Associates in the Twin Cities, a primary care physician group that has been piloting a direct pay primary care model since

2008. In 2013, he founded a health care cooperative, PrimaCare Direct, which

includes over 200 doctors and offers direct pay health care services to employers and patients in the Twin Cities. Mr. Brandt is also CEO of PrimaCare Direct and a board member for the Minnesota Healthcare

Network. In 2013, he received the Emerging

Leader in Healthcare Award from Minnesota Business.

Please tell us about PrimaCare Direct.Technically, PrimaCare Direct is a health care

cooperative made up of health care providers who work together to market medical services directly to patients and employers. I prefer to think of PrimaCare Direct as a group of physician practices that understands how to make positive changes in health care by thinking out-side of the current system. Today’s system is domi-nated by integrated delivery systems that are primarily governed by hospitals. Primary and specialty pro-viders who are employed by hospitals are often “ob-ligated” to refer patients to the hospital. The goal should really be for health care providers to keep patients healthy and out of the hospital. Providers should be free to make decisions with their patients without any outside influence. Cooperative prac-tices that work directly with health care purchasers (patients, employers, and government agencies) can be creative in how they finance and deliver health care.

PrimaCare Direct’s care delivery model is based on a model called direct primary care (DPC) or direct pay medical home. The defining elements of DPC is to create improved access to primary care and to ensure that patients have an enduring and trusting relationship with their primary care pro-viders. Fee-for-service incentives are replaced with a simple flat monthly fee. This empowers the doctor/patient relationship and is how we achieve superior health outcomes, a better patient experience, and lower costs. PrimaCare Direct has also started to include specialty services. Specialty practices can join the cooperative and provide procedures or care packages for one bundled fee instead of having multiple charges from facilities, physicians, and ancillary care providers. Often, specialty physician groups can deliver the same high-quality services in an outpatient setting for 20 percent to 50 percent less than at a hospital.

Would you explain consumer costs and how you figured them?

The flat monthly fee for a patient to enroll in PrimaCare Direct is $75 a month. The monthly fee is capped at four family members, so additional family members are free. To come up with the $75 fee we analyzed Multicare Associates claims data and examined what an active patient (defined as a patient who had at least two visits in the past 18

months) spent annually on services at Multicare by age, gender, and insurance class. We also compared data from different health plans to determine what their per member, per month spend was on primary care. Then we looked at our primary care spend-ing and researched what other direct primary care

practices were charging. The end result was $75 per mem-ber per month. The good news is that this price point is working well, patients and employers seem to find it reasonable, and clinics are happy with the reimburse-ment. We have only a few in-

stances where the costs to care for a specific patient significantly exceeded the monthly fee.

How does your approach to providing access to health care translate into lower overall cost of care?

When discussing cost of care, we often look at chronic disease as being one of the key drivers to cost. Currently, the big trend for employers is to offer a high deductible health plan, but the problem with this is that it discourages patients from visiting their doctor, especially those suffering from chronic diseases such as asthma and diabetes. Instead of managing their care with their primary care pro-vider they wind up in the emergency room, which drives up the cost of care. One ER visit can pay for eight primary care visits. PrimaCare Direct elimi-nates the barrier for patients to see their primary care doctor. It encourages good utilization (teach-ing a patient to use their inhaler properly) versus bad utilization (a patient ending up in the ER with an asthma attack). Independent physician groups have typically been very good at developing outpa-tient capabilities, imaging centers, surgery centers, diagnostic labs, etc., and these services cost less than hospital-based services.

What kind of results have you had with PrimaCare Direct so far?

Early results have been promising. Multicare Asso-ciates has been using this model with its employees for some time and has kept its health plan costs under control for the past seven years. Over that time, the average cost has declined slightly, which is incredible considering that the industry average has increased in cost somewhere between 8 percent to 10 percent a year depending on which source you quote. The current PrimaCare membership is showing a dramatic decrease in ER visits with the

IntervIew

The goal should really be for health care providers to

keep patients healthy.

14 MInnESOTA PhySICIAn April 2015

rate being 112 visits per 1,000 patients ver-sus the norm of 298 visits per 1,000. Groups running the DPC model of care around the country are seeing similar results.

What have been the biggest challenges?

The two biggest and unexpected challenges have been, 1) the number of patients on gov-ernment programs or receiving benefits from a government entity, and 2) dealing with insurance brokers. When we first started marketing PrimaCare Direct to our patient base it was shocking to realize how many patients were receiving insurance through a government agency. We knew how many patients were on Medicare or Medicaid but we didn’t realize the number of government employees who received benefits such as postal workers, state workers, MnDOT work-ers, county workers, etc. This is a barrier for PrimaCare because it is rare for govern-ment employees to have a high deductible or any deductible at all unlike private sector employees where a $5,000 deductible is the norm. This just means that the PrimaCare model does not currently apply to these workers, but that may change over time.

The other barrier is dealing with in-surance brokers who are generally paid in commission from the insurance company

they work for. This sets up a weird incentive where their commission increases when a premium goes up, yet, they claim to be working on an employer’s behalf. A lot of these brokers don’t really have a solid grasp of how health insurance works and even less knowledge about how health care is deliv-ered. So trying to find brokers to work with who understand the PrimaCare Direct model and are not afraid to make changes has been difficult.

How can physicians become involved? PrimaCare Direct is open to both primary and specialty practices in Minnesota and western Wisconsin. We are looking for physicians who want to help us continue to develop our business model of keeping the focus on patient-centered care, where the patient is the client and a true physician/ patient relationship is the key to success.

PrimaCare Direct does not cover major medical events. How do you advise patients to obtain this coverage?

We advise patients to obtain a high deduct-ible health plan to insure against cata-strophic events (such as cancer or traumatic injury). PrimaCare Direct is currently work-ing to develop and sell its own high deduct-

ible health plan that pairs with our direct primary care plan.

How can employers become involved?If an employer is searching for a way to lower their health care costs without sac-rificing access, coverage, or quality then PrimaCare Direct is a potential solution. Our care model, coupled with our third-party administrator and stop-loss partners, can customize a solution for a company’s employees.

In an ideal world, what does the fu-ture hold for PrimaCare Direct?

Ideally, I would love to see PrimaCare Direct grow to cover over 10,000 people here in the Twin Cities within the next year. At that scale it would be hard to refute our results and it would be easier to more aggressively mar-ket the concept. This is a stretch goal, but I think it is very doable at our current pace as we have more than 200 doctors currently on board who care for over 300,000 patients. If we can convert over 3 percent of those to the new model we can achieve this goal. From there, I would like to see us grow the model to include a large enough portion of any doctor’s panel that they can change the way they deliver care for all patients, not just those enrolled in our program.

April 2015 MInneSOTA PhySICIAn 15

Education is essential to achieving and sustaining quality healthcare. Through partnership with healthcare leaders, our educational activities help advance quality improvement and patient care initiatives.

LIVE ACTIVITIES

Maintenance of Certification in Anesthesiology (MOCA) Training April 18, 2015

ONLINE COURSES (CME credit available)www.cme.umn.edu/online

• Adolescent Vaccination• Nitrous Oxide for Pediatric Procedural Sedation• Preventing Chronic Pain - A Human Systems Approach• Global Health

- To include Travel Medicine & Refugee Health- Family Medicine Specialty- Pediatric Specialty

For a full activity listing, go to www.cmecourses.umn.edu

Pediatric Orthopaedic Trauma Summit 2015 September 24-25, 2015

Live Global Health Training (weekly modules)May 4-29, 2015

Midwest Cardiovascular Forum - Controversies in Cardiovascular DiseaseMay 16-17, 2015

Bariatric Education Days: Advances in Bariatric CareMay 27-28, 2015

Workshops in Clinical Hypnosis June 4-6, 2015

Topics & Advances in Pediatrics June 4-6, 2015

2015 CPD Activities(All courses in the Twin Cities unless noted) www.cmecourses.umn.edu

University of Minnesota - Continuing Professional Development

Office of Continuing Professional Development612-626-7600 or 1-800-776-8636 • email: [email protected]

Promoting a lifetime of outstanding professional practice

Twin Cities Sports Medicine Conference 2015 October 2-3, 2015

NPHTI Pediatric Clinical Hypnosis Workshops October 15-17, 2015

Psychiatry Review 2015 October 5-6, 2015

Practical Dermatology 2015 October 16-17, 2015

Donald Gleason Conference on Prostate and Urologic Cancers October 23, 2015

screening revealed his was in the vicinity of 190/100—alarm-ing and far too high to undergo the dental procedure.

Dr. Rinaldi shared his concerns and told the patient that he needed to get a medical clearance letter from his physician before he would perform the procedure. The patient visited his family phy-sician and eventually received clearance after his doctor prescribed medications to treat his condition. Dr. Rinal-di later learned that the patient underwent further diagnostic testing, and his physician discovered an adrenal gland tumor that he surgically removed.

When Dr. Rinaldi saw this patient a few months later, he discovered the patient had undergone an amazing trans-

formation. To his surprise, the patient had lost a dramatic amount of weight. He told Dr. Rinaldi he hadn’t felt that good in years and expressed how grateful he was that his den-

tist actually took his condition seriously and prompted him to see his doctor. Dr. Rinaldi said this experience was a sobering reminder of the importance of the screenings we perform in our dental practices and the implications it can have on our patients’ health.

Integrating oral health and overall healthIn most people’s minds, dentistry has historically been about teeth. While that is still largely true, a growing number

of today’s dentists are more focused on the comprehensive health of the oral cavity, as well as maintaining an astute aware-ness of its association with the overall health of the body.

Dr. Rinaldi’s patient is a great example of the need for a broader focus on overall health

and how dentists and physi-cians must make an effort to work jointly on behalf of their patients. There is ample oppor-tunity for dentistry and medi-cine to integrate the oral health dimension into a model of total patient-centered, overall health. Medical/dental collab-oration could take place in five key areas: 1) education and training; 2) emergency room oral health services; 3) chronic disease management; 4) in-hos-pital oral health consultations; and 5) dental office health screenings.

Education and trainingWith regards to education and training, the mouth has

traditionally been the dentist’s territory. As a result, many physicians have little more than a basic understanding of many oral health issues. Physicians would benefit from training op-portunities—most likely in the form of continuing education or specialized training sessions—provided by practicing dentists

16 MInnesoTA PHysIcIAn April 2015

Forging new alliances from cover

Physicians do not have access to the data that dentists collect.

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Dr. James Rohde, Allina Health

or dental school instructors.Physicians could even per-

form some simple oral proce-dures. For example, it would be beneficial to their patients if pediatricians offered fluoride treatments, es-pecially if their practice works with children who have lim-ited access to a dentist.

Emergency room oral health servicesIt’s becoming more common for patients with dental condi-tions to show up in the emer-gency room for treatment. This typically isn’t ideal for the pa-tient or the hospital and it’s very expensive. A recent Minnesota Department of Health report in-dicated that approximately $148 million has been spent over the last three years in Minnesota on dental conditions that are taken care of in hospital emer-gency rooms. There is a better solution.

Patients presenting with dental issues in an emergency room is another area where dentists and physicians could coordinate efforts. one oppor-tunity would be to divert or transfer the patient—barring the absence of other significant injuries—to a dental office to receive the appropriate care. If a patient needs to remain within the emergency room, the opportunity still exists for a dentist to provide clinical care. That care could be in the form of a 24/7 hotline in which a dentist is on call to help treat the injury or provide a phone consultation.

Chronic disease managementAs a physician, you see the prevalence of chronic medical conditions such as diabetes, heart disease, cerebrovascular disease, and rheumatoid ar-thritis, to name just a few. With our country’s aging population, these conditions will continue to be a challenge for our health care system.

Many of these patients with chronic conditions suffer from

poor oral health. A more ag-gressive collaboration between physicians and dentists to address this issue would create a number of benefits. A collab-

oration, where oral and medi-cal-related issues are addressed in tandem, could improve a pa-tient’s overall health and quality of life. This approach may also reduce the patient’s out-of- pocket medical expenses, as well as medical costs incurred by their employer or medical assistance program.

With this collaborative approach, our health care organizations may also realize long-term savings as a result of a patient’s better overall health. A recent study by United con-cordia Dental supports this theory. United concordia Den-tal found that people who were pregnant or had chronic condi-tions and received and main-tained treatment for periodon-tal disease saw dramatic drops in hospitalization and physician visits, saving thousands of dol-lars a year in medical costs.

A program designed to address oral health and chronic disease management should be part of most large health care systems. The objective of this program would be to identify patients with chronic health issues and assess their oral health status. This program could then work with their health insurance or medical assistance plans to ensure that their oral health needs are ap-propriately addressed.

In-hospital oral health consultationsThroughout Minnesota, there aren’t many dentists on hospital staffs. There are, however, occa-

sions when in-patients require a dental/oral consultation. It is difficult for physicians to set up dental consultations and any recommended treatment in a

timely manner when a patient is in the hospital.

This is clearly an opportunity for health care organizations that do not have dentists on their staff to establish rela-tionships with dentists in their communities. once again, with the right working relationship, it could truly enhance the care provided to the patient.

Dental office health screeningsMany dental teams already reg-ularly perform basic medical screenings, including those for hypertension, oral cancer, and

TMJ facial pain issues. Park Dental is piloting a screening program for sleep apnea and looking at other op-portunities, such as inquiring about a pa-tient’s im-

munization history, screening their glucose levels, or offering smoking cessation education.

For some patients, their semiannual dental visit might be the only time they see a health care professional during any given year and health-relat-ed issues can certainly surface in that timeframe, especially as

April 2015 MInnesoTA PHysIcIAn 17

The ultimate goal is to advance the overall health and quality of life of our patients.

Forging new alliances to page 38

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V Center for Urinary and Pelvic Health, including urodynamics.

V Nutrition and wellness consultations.

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and health reform initiatives such as accountable care.

Since 2004, members of Minnesota’s health care com-munity have convened regu-larly as part of the Minnesota e-Health Initiative to develop a statewide plan to meet the goals for statewide adoption and use of EHRs. This plan includes es-tablishing uniform health data standards for securely shar-ing data across systems. The e-Health Initiative continues to monitor state and national activities and guides Minne- sota providers on how they can leverage EHRs to achieve the promised benefits of the Triple Aim: improved patient expe-rience of care, reduced health care costs, and improved public health. This article presents the latest data available on e-health among Minnesota’s ambulatory clinics.

Based on data collected each year by the Minnesota Department of Health using an an-nual survey of the state’s 1,400 ambu-latory clinics, Minnesota is a leading e-health state. Nine in 10 clinics (93 percent) and all Minnesota hospitals have adopted an EHR. Adoption rates vary among other settings of care, ranging from 97 percent among the state’s local health depart-ments, to 69 percent of nursing homes (as of 2011), and even lower rates for settings that have not had access to Centers for Medicare & Medicaid Ser-vices (CMS) incentive funding. Table 1 on page 19 shows trends in clinic EHR adoption over time.

Why Is the mandate important?

Effective use of EHRs The value from investing in and implementing an EHR system comes from using it effectively to support efficient workflows

and effective clinical decisions; in participating in voluntary and required quality reporting initiatives; and in contribut-ing to the improved health of individuals and populations. Effective use of EHRs means that the EHR includes tools and processes such as e-prescrib-ing, clinical decision support tools (see Table 2 on page 19), and that staff are adequately trained to use the technology. EHRs are most effective when using nationally recognized standards that enable in-teroperability with other EHR systems.

Interoperability and health information exchange

The goal of health informa-tion exchange (HIE) is to make health information available, when and where it is needed, and to improve the quality and safety of health and health care. Currently, most of the HIE occurring in Minnesota is pri-

marily between hospitals and clinics in the same system or with affili-ated partners. About one-third of Minnesota clinics are ex-changing with unaffiliated

hospitals or clinics, although their need to exchange infor-mation is much higher (see Table 3 on page 19). Electronic exchange with unaffiliated labs, behavioral health providers, and nursing homes is much lower. Common challenges for exchange include the limited capacity of others to exchange, lack of technical support or expertise, competing priorities, cost and return on investment, and managing privacy issues.

HIE is happening through a variety of mechanisms (see the sidebar about HIE transactions on page 36). The most common mechanism for health infor-mation exchange is through a common EHR, for example, Epic. HIE is also happening between organizations that

18 MINNESoTA PHySICIAN April 2015

leveraging information technology from cover

Health care providers are

embracing e-health.

To meet the requirements of the statute, providers must use an EHR that is certified by the Office of the National Coordinator (ONC) pursuant to the Federal Health Information Technology for Economic and Clinical Health (HITECH) Act. Sample EHR certification criteria:

• Provides clinical decision support

• Supports physician order entry

• Captures relevant health care quality information (e.g., patient safety, care coordination, clinical processes/effectiveness, and population and public health)

• Exchanges electronic health information with, and integrates such information from, other sources

More information, including a comprehensive list of ONC-certified EHRs, is available at www.healthit.gov/policy-researchers-implementers/certified-health-it-product-list-chpl

If a certified EHR is not available for a particular specialty or setting, MDH provides guidance on the recommended capabilities. MDH’s Guidance for Understanding the Minnesota 2015 Interoperable EHR Mandate is available at www.health.state.mn.us/e-health/hitimp/

EHR requirements and guidance

mation with other providers to optimize patient care (see the sidebar about EHR require-ments above). Across the na-tion, this concept of “e-health” has become a powerful strat-

egy to transform access, care delivery, patient experiences, and health outcomes. E-health is also essential in supporting the exchange of information necessary for care coordination

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Table 2. Clinic trends in the use of clinical decision support tools in Minnesota

Table 1. Trends in the adoption of electronic health record systems among Minnesota clinics, 2005–2014

Table 3. Minnesota clinics’ electronic health information exchange by type of organization, 2014

leveraging information technology to page 36

use a different ehR, either as a peer-to-peer connection or through an hie intermediary. in Minnesota, providers who do not operate through the same hiPaa affiliation are required to exchange health information using a state-certified hie ser-vice provider.

interoperability is the ability of two or more systems or com-ponents to exchange informa-tion and to use the information

that has been exchanged accu-rately, securely, and verifiably, when and where needed. in the context of hie, interoperability is achieved by using standard-ized terminology and data structure in the various types of clinical data transactions (e.g., clinical summaries, lab results, immunizations, etc.). While most of these standards have been developed, adoption and use of these standards is still limited.

Compliance the Minnesota De-partment of health (MDh) recognizes that some providers may not have achieved the interoperable ehR Mandate by Jan. 1, 2015. MDh does not have enforcement authority over Min-nesota’s 2015 ehR mandate, and does not issue fines or sanc-tions against providers that have not met the mandate’s require-ments. instead, MDh provides support to providers to help them achieve the goal of statewide interopera-bility. the Minnesota e-health advisory committee and MDh recommend that all providers demon-strate progress toward

achieving the ehR and interoperability requirements. Poten-tial benefits of compli-ance may include:

• increased effi-ciency and quali-ty outcomes

• improved ability to avoid adverse events

• timely access to information from patients’ other providers

Looking to the futurethere is demand nationwide to improve our country’s health care system. When Minnesota’s ehR Mandate passed, it was groundbreaking and forward-looking in its commitment d

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Wilderness Health is a nonprofit regional collaborative, con-

sisting of nine independent hospitals and health systems in northeastern Minnesota. It was officially incorporated in December 2013 as a nonprofit corporation in Minnesota, how-ever, the idea of independent facilities working together was born years earlier.

The cost of health careMultiple changes in the health care industry are driving changes in reimbursement as well as patient utilization. Since 2006, the inpatient rate has dropped throughout the U.S. with Minnesota experiencing the greatest rate of reduction at 13 percent. The trend is ex-pected to continue throughout the next decade, even in states with loosely managed utiliza-tion trends. Minnesota, consid-ered to be a state with conser-vative admitting patterns and an overall healthier population,

can expect to see admit rates continue to decline.

Another key issue impacting revenue is the shift by payers, starting with Medicare, from quality incentives to penalties. Hospital-acquired infections and readmissions are reducing payment rates for providers.

Patients can and should expect high-quality care from providers. The burden for pro-viders is ensuring that there is staff available to interpret the measures, review and report on results, and identify and implement opportunities for improvement. The challenge is in the delay between the

reporting and the impact to reimbursement—sometimes a gap of several years.

Out-of-pocket costs for patients have risen dramati-cally over the past decade as employers have shifted costs to employees in an effort to slow employee benefit costs. A November 2014 study by the Kaiser Family Foundation found that the average worker deductible increased from $584 in 2006 to $1,217 per person in 2014. Deductible costs for individuals not covered by employer-sponsored health insurance are even higher. The average annual medical de-ductible in 2015 is $2,563 for silver exchange plans with a combined medical/prescription drug deductible; in silver plans with separate medical and drug deductibles, the average annual medical deductible is $3,456. Copays and co-insurance add additional patient costs. Many patients are choosing to delay medical care as a result of their out-of-pocket costs.

Regional demographicsIn addition to reimbursement changes, health systems in northeastern Minnesota are challenged by the demograph-ics in the region. According to the 2013 County Health Rank-ings study, all counties in Wil-derness Health’s service area:

• Have more people over age 65 than the state and national averages

• Consistently report more poor/fair health days, poor physical health days, and poor mental health days than the state averages

• Rank in the bottom 20 percent of health rankings (except for Cook, which has the smallest population)

Medicare is the largest payer for all Wilderness Health members and many have a significant number of Medicaid patients also, meaning that con-tracted rates are much lower than other payer types.

Forming the collaborativeGiven these financial chal-lenges, several hospitals in northeastern Minnesota began discussions several years ago to identify how they could work together in a more cost-ef-fective, efficient manner that would maintain their indepen-dence yet still provide their patients with quality health care. The governance structure among the participants varied. All are nonprofits, but some are hospital districts with public boards, some owned nursing homes, and most are critical access hospitals. Many do not employ physicians in their fa-cilities and instead have Feder-ally Qualified Health Centers (FQHCs) or independent physi-cians in their communities.

After much discussion, the group agreed to a governance structure that allowed for a variety of provider types to join the collaborative without jeopardizing anyone’s nonprofit status or reimbursement struc-ture. The groups that initially joined the collaborative would be considered charter mem-bers, with approval rights re-served on any new groups that wanted to join at a later date. Discussions continue with addi-tional hospitals, clinics, pro-vider groups, and stakeholders (such as local counties) about how we can work together.

All members have agreed to resource commitments, includ-ing financial and time, in order to be part of the collaborative. Each charter member has a seat on the board of directors, regardless of size. Members delegate a senior executive from their organization (typi-cally their CEO) to serve on the board. Membership agreements and budget allocations were approved for 2014 and 2015 to launch the organization. Be-cause of the large geographical area (and traveling distance)

PRacTice ManageMenT

Wilderness HealthProviding care in

northeastern Minnesota

By cassandra Beardsley

20 MINNESOTA PHySICIAN April 2015

that Wilderness Health covers, most meetings are held virtu-ally via webinars and confer-ence calls.

charter membersThe charter members of Wil-derness Health are located in some of the most rural areas of Minnesota and patients often must travel many miles for access to services. Seven of the nine charter members are critical access hospitals of 25 beds or less. Six facilities also have long-term care facilities on their campus, many of which are owned by the hospitals themselves. Here are the char-ter members:

Bigfork Valley Hospital (Bigfork, Minn.)

• A general medical and surgical hospital with 20 beds

• Four specialty clinics, a pharmacy, and senior services (adult daycare, home care, long-term care, and an indepen-dent/assisted living facility)

• Government hospital district

Community Memorial Hospital (Cloquet, Minn.)

• A critical access, general medical, and surgical hospital with 25 beds, a 44-bed long-term care facility, and two clinics

• Non-government, not-for-profit

Cook County North Shore Hospital (Grand Marais, Minn.)

• A critical access, general medical and surgical hospital with 16 beds and a 37-bed skilled nursing facility


Cook Hospital (Cook, Minn.)

• A critical access, general medical and surgical hospital with 14 beds and a 28-bed skilled nursing facility


Fairview Range/Range Regional Health Services (Hibbing, Minn.)

• Three primary care clin-ics; memory care, home care and senior services; an inpatient behavioral health unit; a pharmacy; and a general medical and surgical hospital with 81 beds


Lake View Hospital (Two Harbors, Minn.)

• A critical access, general medical and surgical hospital with 17 beds, one primary care clinic, and a pharmacy

• Non-government, not-for-profit; part of St. Luke’s health care system

Mercy Hospital (Moose Lake, Minn.)

• A critical access, general medical and surgical hospital with 25 beds, an adjacent skilled nursing health care center, and an assisted living facility


Rainy Lake Medical Center (International Falls, Minn.)

• A critical access, general medical and surgical hospital with 25 beds and one primary care clinic


St. Luke’s (Duluth, Minn. and surrounding communities)

• A health care system with 267 hospital beds, 13 primary care clinics, 23 specialty clinics, one

pharmacy, six urgent care clinics, and one express care site

• The primary care clinics in Minnesota are lo-cated in Duluth (seven), Hermantown, Hibbing, Mt. Iron, Silver Bay, and in Wisconsin in Ashland and Superior


Meeting the Triple aimOur members are working together to promote the Triple Aim, which calls for improv-

ing care, improving health, and lowering costs. There are some initiatives that will be addressed during the first years of the collaborative.

• Coordinate and improve patient care using evi-dence-based medicine

• Integrate data between entities to enable better care coordination and care planning for patients

• Provide quality, local health care in our commu-nities

• Identify shared service op-portunities between partic-ipating entities to maxi-mize operating efficiencies and reduce costs

• Explore alternative pay-ment opportunities, such as accountable care organizations (ACOs), with payers as the system tran-sitions from fee-for-service to fee-for-value

Wilderness Health to page 34

April 2015 MINNESOTA PHySICIAN 21

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There is good news for health care providers who evaluate and treat

women with endometriosis. Emerging evidence in the field of minimally invasive gynecol-ogy is helping those who treat endometriosis to better under-stand the treatment modalities that are effective in managing this enigmatic disease. Endo-metriosis affects 6 percent to 10 percent of reproductive aged women and is one of the most common sources of chronic pelvic pain.

Endometriosis refers to the presence of viable, es-trogen-sensitive endometrial glands and stroma with an associated inflammatory re-sponse outside of the uterus. Several conditions show greater concordance with endometrio-sis: 21 percent to 47 percent of women presenting with subfer-tility; 71 percent to 87 percent of those with chronic pelvic pain; and 69 percent of adoles-

cents with nonresponsive pelvic pain. Endometriosis also has a strong familial component and first-degree relatives of indi-viduals diagnosed with endo-metriosis are seven to 10 times more likely to have the disease themselves.

Economic burdenEndometriosis is a public health issue that bears an important economic burden. It not only causes pain and infer-tility, but also has consequences related to medication, health care consumption, work absen-teeism, impaired quality of life, and psychosocial factors. The

estimated annual health care burden in the United States for endometriosis exceeds $20 bil-lion. This annual cost actually supersedes that of Crohn’s dis-ease ($865 million) or migraine care ($13–$17 billion).

Most experts agree that the disease is multifactorial in etiology but distinct pathophys-iology is not well understood. Factors such as retrograde menstruation, metaplastic changes of pleuripotent meso-thelial cells, and implantation of cells through hematogenous or lymphatic embolization may play a role in the development of endometriosis. While most women appear to have some degree of retrograde menstru-ation, not all women develop endometriosis. Those who have endometriosis may have an inherent immune dysfunction that impairs normal clearance yet promotes disease progres-sion.

TreatmentLaparoscopy is considered the gold standard for the diag-nosis of endometriosis with visual identification of classic endometriosis lesions. Histo-logic confirmation is helpful because visual identification is associated with a high false positive rate. Many patients may be erroneously diagnosed with or without endometriosis due to the lack of a biopsy of the peritoneum at the time of surgery to provide histologic proof of the existence of endo-metrial glands and stroma in the sample.

Medical management of en-dometriosis involves hormonal suppression of endometriosis with oral contraceptives and GnRH agonist medications. The aim of medical management

is to reduce the pain associ-ated with endometriosis. These therapies can be effective but symptoms usually reoccur shortly after the medication is discontinued.

Surgical management of endometriosis has largely focused on the destruction or removal of all visible endome-triosis lesions. These lesions can take many forms, with the classic presentation being a powder-burn appearance on the surface of the abdominal peri-toneum. Endometriosis lesions can also be red, blue, white, or have a more flattened, scarred appearance. Many providers believe that simple ablation of the superficial endometriosis implants is an adequate surgi-cal treatment for the disease. This is usually accomplished with the use of bipolar or monopolar electrocautery. The lesions are usually burned su-perficially without exploration and removal of the underlying retroperitoneal tissue. Evi-dence suggests that this type of therapy is inadequate and that true excisional surgery is much more effective in alleviating pain due to endometriosis and preventing recurrence of the disease.

Most patients have their pain return in less than a year after having ablative, non-exci-sional surgery. More important, these methods do not allow confirmation of visual diagno-sis by a pathologist. Safety of their application to endometri-osis treatment has been ques-tioned.

Emerging evidenceA recent randomized, con-trolled trial by Healy, et al. reports on five-year follow-up data on patients who under-went excisional surgery versus ablation surgery for endometri-osis. Published in the December 2014 issue of the Journal of Minimally Invasive Gynecology (JMIG), this study compares the efficacy of these two sur-gical modalities for a variety of outcomes. Their previously published, one year follow-up

WomEn’s HEalTH

EndometriosisImproved outcomes through

new technology

By matthew Palmer, Do

22 MInnESoTA PHySICIAn April 2015

data revealed no difference in pain scores among patients treated with either modal-ity. However, when the same patients were interviewed five years after their surgery some differences emerged. of those that returned the pain assessment survey after five years, 45 patients had undergone excisional sur-gery and 42 patients had ablative surgery for endo-metriosis. Both modalities in surgical management proved effective in reduc-tion of overall pain including menstrual-related pain and pain with voiding or defecation. The statistically significant difference was revealed in that patients who had undergone excisional surgery had less pain related to dyspareunia and less need for medical therapy after surgery. It is possible that if the response rate of the survey had been higher, more differences may have been found. This study does help us to under-stand that deep infiltrating dis-ease, which is often the cause of dyspareunia, is better treated with excisional surgery.

advanced surgeryWhen considering where to refer a patient for management of endometriosis or chronic pelvic pain it is important to understand what patients can expect from their surgeons. Surgeons performing endome-triosis resection surgery must be comfortable with compli-cated pelvic adhesions and dissection of retroperitoneal anatomy. They must be able to navigate bladder and bowel involvement of endometriosis and resect the diseased tissue from these structures. Endo-metriosis surgeons should be able to repair any bladder and bowel defects caused during resection surgery and must be able to navigate the challenges of a frozen pelvis. Gynecolo-gists performing endometrio-sis surgery must have a close working relationship with like-minded colleagues in the fields of urology, colorectal,

and general surgery to ensure effective and complete surgical resection. Surgical resection can be planned and completed for even the most challenging of patients.

Additional research reveals that endometriosis is being detected and treated more effectively than ever with ad-vanced laparoscopic surgical technology and the da Vinci surgical robot. Robotic surgery allows the surgeon to work comfortably, reducing fatigue from standing and bending in a long surgical case. Advanced optics allow visualization in high definition with 10x mag-nification and 3D and many surgeons believe they can see more disease than they were able to with a traditional lap-aroscope. Delumba and col-leagues reported a 78.2 percent endometriosis detection rate in patients who underwent robotic excisional surgery for supected or known endometriosis.

Additionally, advanced ro-botic technology such as Firefly uses integrated fluorescence imaging capability, which pro-vides real-time, image-guided identification of key anatomical landmarks using near-infrared technology. This technology, which has been used since the 1970s for angiography and hemodynamic monitoring, is now finding an application in minimally invasive gynecology. Firefly takes advantage of the highly vascular nature of endo-metriosis and helps surgeons identify areas of neovascular-ization, which is common in this disease. Leaders in endo-metriosis resection feel that this technology may ultimately help surgeons see more endo-metriosis and obtain better surgical margins for resection. While this technology remains

unproven in a large multicenter trial, data from Ken Levey, MD, published in April 2014, shows a high rate of detection of endometriosis in specimens resected using Firefly. Endo-metriosis was detected in 78.8

percent of specimens biopsied during resection surgery, and in many cases, these areas would not have been removed unless shown to be positive via infra-red vision.

ConclusionEndometriosis is a common disease in women of child-bearing age. This disease can be difficult and challenging to manage for health care pro-

viders across all spectrums of women’s health care. With recent advances in minimally invasive surgery and surgical technology, the management of endometriosis is becoming better understood. As mini-

mally invasive surgeons continue to move the man-agement of endometriosis forward, we are hopeful to see a reduction in the long-term consequences of this disease. Referring physicians should seek out those providers who are

comfortable with management of all presentations of endome-triosis. A collaborative effort is needed to continue to move this effort forward.

Matthew palmer, DO, is board-cer-tified in obstetrics and gynecology, and practices with Oakdale Ob/Gyn in Maple Grove, Plymouth, and Crystal. He specializes in minimally invasive surgery with a focus on managing uterine fibroids, endome-triosis, and pelvic organ prolapse.

April 2015 MInnESoTA PHySICIAn 23

Endometriosis is a public health issue that bears an important economic burden.

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President Obama an-nounced his Precision Medicine Initiative on

Jan. 30, 2015 (www.whitehouse.gov/precisionmedicine). Har-old Varmus, director of the National Cancer Institute, and Francis Collins, director of the National Institutes of Health, outlined what the initiative could achieve in a recent issue of the New England Journal of Medicine. The initiative involves a $215 million invest-ment that will be launched in 2016. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are just two organizations that will work to develop the resources necessary to attain these objectives: 1) more and better treatments for cancer, 2) creation of a voluntary national research cohort, 3) commitment to protecting privacy, 4) regu-latory modernization, and 5) public-private partnerships. At the center of precision medicine is pharmacogenetics.

What is pharmacogenetics?Different patients can show dra-matically different responses to the same medication. Physi-cians and patients are often left waiting to see if a new medica-tion works and if it is safe. Tests based on an individual’s genetic composition may allow the treating physician to determine if a medication will be safe and effective for an individual patient without the need for several months of clinical ob-servation. For example, patients lacking glucose-6-phosphate dehydrogenase (G6PD) activity are more prone to increased side effects from a number of medications. What other genetic

variations can lead to altered response to medications? Pharmacogenetics, sometimes called personalized medicine, is the study of genetic influences on an individual’s response to medications. The ultimate goal is to use genetic information to tailor drug therapy that is safe and effective. It is also being used to discover new targets for drug therapy. Pharmaco-genetics generally refers to a relatively small number of genetic markers, while phar-macogenomics usually refers to a set of markers spanning the entire genome.

Individual enzyme testingThe FDA maintains a list of approved drugs with phar-macogenomic information on their labeling. Labeling does not translate directly to genetic testing, however. As of Aug. 18, 2014, more than 150 drugs had pharmacogenomic labeling. Some of these drugs include the commonly prescribed celecoxib, codeine, glipizide, metoprolol, and warfarin. Classical phar-macokinetics can describe drug absorption or uptake, metabolic activation or deactivation, and elimination. These pharmacoki-netic properties are determined by enzymatic activity that itself is determined by genetic se-quence. Variation in sequences in genes active in any pharma-cokinetic process can alter the activity and side effects of a drug. Predicting how genetic variation will affect pharmacokinetics in any one individual is the promise of pharmacog-enomics.

Most medications are sub-jected to a variety of metabolic enzymes that alter the drug. If

a drug is metabolized slowly, it may reach higher or more toxic levels. If a drug is metabolized quickly, it may be eliminated before reaching effective levels. One large family of drug me-tabolizing enzymes is known as cytochrome P450. Variations in toxicity and activity of a large number of medications are in-fluenced by variations in genes coding for P450 enzymes.

Tamoxifen is an example of a commonly used medication that is metabolized by a cyto-chrome P450 enzyme. One of the P450 enzymes is responsible for converting tamoxifen into a more active form. Genetic poly-morphisms (variations that are more common than 5 percent in the general population) within this particular P450 gene can be responsible for less tamoxifen activation. Whether people with the less active P450 enzyme have different breast cancer outcomes is currently under investigation.

Warfarin is another drug that is metabolized by P450 enzymes. Clinical genetic tests are available to determine if an individual is likely to inactivate warfarin quickly or slowly, and may aid in initial dosing deci-sions. Since clotting times are measured so frequently with international normalized ratios (INRs), the genetic test is rarely used clinically and there is no universal agreement as to its cost effectiveness.

Genetic variations in genes leading to altered drug metab-olism are fairly rare in the gen-eral population. Therefore, test-ing individual enzyme activities would lead to a large number of negative tests. The inefficiency of this approach has limited routine enzymatic testing.

Genetic testingAn alternative to individual enzyme tests is genetic testing. The gene coding for important enzymes in drug metabolism can be sequenced to determine if a person is likely to have

professIonal update: GenetIcs

pharmacogeneticsTailoring drug therapy

Ken dornfeld, Md, phd, and catherine a. Mccarty, phd, MpH

24 MINNESOTA PHySICIAN April 2015

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abnormal drug metabolism. The appeal of this approach is the increasing efficiency in se-quencing genes. The human ge-nome consists of 3,000,000,000 base pairs. The first draft of the sequence was deciphered in 2000 at a cost of $3 billion. This large invest-ment initiated a wave of innovation leading to a dramatic drop in the price of DNA sequencing. This technologic revolution makes testing the genes of interest more cost efficient than testing enzyme activity. Some companies have offered DNA sequencing services directly to the public. The genes sequenced include those responsible for some genetic disorders as well as genes involved in drug metabolism. One company that offers these sequencing ser-vices, 23andMe, was required to stop in November 2013 by the FDA. The issue that forced the suspension is whether DNA se-quencing is a medical test sub-ject to FDA control or simply a source of personal information not subject to FDA regulation. The case with 23andMe is still ongoing and shows how rapidly this technology is changing. This case also highlights the novelty of genetic information and underscores the need for new approaches to manage genetic data. The Genetic Infor-mation Nondiscrimination Act (GINA) was passed in 2008. It prohibits health insurance and employment discrimination based on genetic information. However, as the 23andMe case highlights, several aspects of regulation are still evolving.

Sequencing the entire genomeThe efficiency of DNA sequenc-ing continues to accelerate. A significant milestone was reached last year when Illu-mina announced its ability to sequence the entire genome for $1,000. From a pharma-cogenetic standpoint, this is a major development and means that instead of specialized tests

for several different genes or enzyme activities, a single test, sequencing a person’s entire genome, can provide informa-tion on how an individual is likely to respond to a variety

of drugs. The hope of person-alized medicine is to use this personal sequence information to increase the specificity and effectiveness of disease preven-tion and treatment.

PleitropyPleiotropy is another challenge for clinical translation of ge-netic discoveries. Pleiotropy is the influence of a gene on more than one outcome. For example, complement factor H, which is thought to be responsible for 70 percent of age-related macular degeneration (AMD), may also be related to Parkinson’s dis-ease. There is a commercially available genetic test for AMD that includes complement factor H results, but does not provide information about Parkinson’s disease.

Another example is CyP2C9, one of the genes that explains warfarin metabolism. If a clini-cian orders a CyP2C9 genetic test that is commercially avail-able, they will likely not be told that there are available guide-lines for dosing tolbutamide, phenytoin, and a number of other medications based on CyP2C9 genotype.

The genetic sequence of cancersThere are even greater genetic variations between cancers than genetic differences be-tween individuals. The same revolution in technology that allows rapid DNA sequencing of normal genomes has allowed investigators to determine the genetic sequence of cancers.

The normal DNA sequence and cancer DNA sequence from the same individual can be com-pared to find unique genetic changes in the cancer. These genetic differences may serve as

targets for therapy. The genetic changes seen in cancer are very diverse and incompletely under-stood. However, some genetic changes are seen frequently and have been used to develop specific therapies.

One example is Herceptin, also known as trastuzumab. Approximately 20 percent of breast cancers contain an over-abundance of the growth factor gene Her2. Excess Her2 leads to excess cell growth. Herceptin

can block the growth-promot-ing action of Her2 and improve control of these cancers. Every patient diagnosed with breast cancer is now tested for the Her2 genetic abnormality and

Herceptin is offered only to patients with tumors containing this abnormal-ity. Her2 amplification is also seen in a minority of esophageal cancers. The benefit of Herceptin for these patients is under investigation. Therapy

targeted against the epider-mal growth factor receptor (EGFR) improves the outcome for colorectal cancer patients but only those that do not have mutations in genes acting downstream of EGFR. Testing cancers for mutations in one downstream gene, KRAS, is now standard for patients with colorectal cancer.

Several other cancer treat-

April 2015 MINNESOTA PHySICIAN 25

pharmacogenetics to page 32

Different patients can show dramatically different responses to the same medication.


Allied Professions

this past august, i was one of thousands of home care workers who voted

in the largest union election in Minnesota history to form our union with seiU healthcare Minnesota. this vote was a his-toric moment in the fight that we are still waging to improve the home care field for both workers and the seniors and people with disabilities that we serve.

My storyi had over 10 years of experi-ence working in health care when a family i knew experi-enced a tragic loss. as a result, i ended up becoming a home care worker for the first time for a young girl named Jayla. Jayla’s dad was the main care-giver for her until he passed away in December 2008. Jayla’s mom, my friend sarah, was left caring for a special-needs child on her own, and desper-ately needed help. i saw a little girl who deserved to be able to spend her time at home, not

in an institution. i knew that if i cared for Jayla she could remain at home. i had no idea what challenges awaited me as a home care worker though!

Jayla was born with pul-monary hypertension and a genetic disorder called opitz syndrome. she is also deaf. she requires breathing treatments and thickened liquids, and needs help eating, toileting, and performing many other basic activities that require support every single day.

i have a strong desire to care for others, and i know that it is beneficial for people to be able to stay in their homes while

receiving the care they need. it gives the person being cared for a sense of dignity and indepen-dence. in the home care work-ers’ campaign that i have come to lead over the last couple of years, we want both home care consumers and the workers who serve them to be able to live the lives they choose.

When i first started caring for Jayla, i was offered benefits such as health insurance and vacation time. But over the past few years, my pay has been cut, my vacation time taken away entirely, and the health insurance offered is impossi-bly expensive and only covers catastrophes. i no longer have the option of taking a day off because i can’t afford to lose the pay. When i gave birth to my daughter last year, i had to return to work the day after i got out of the hospital, even though i’d had a c-section.

forming a unionMy story is all too familiar to the tens of thousands of home care workers in Minnesota, and it is why we fought for and won the right to vote on forming a union in 2013. a resounding majority of workers voted to form a union in august 2014.

We have reached a tentative agreement with the state. the contract, which was ratified by members and now needs to be ratified by the Minnesota Legis-lature, makes many important gains for home care workers. We will go from zero to five days of paid time off, have a dedicated training fund, have the pay floor raised to $11 per hour, and finally have a voice on the job. in other states with established home care unions, increases in pay, benefits, and training have led to less turn-over, more stability, a better

prepared workforce, and higher quality care.

everyone who has looked into our growing long-term care system understands that home care offers not just independence and quality of life, but huge taxpayer savings, compared to nursing homes or other institutional care. and in illinois alone, attorney Gener-al Lisa Madigan has reported that the reduction in turnover that occurred when home care workers won better pay and benefits through their union has saved the state over $600 million.

How the union affects home care consumershome care consumers (people with disabilities and seniors who receive in-home support services through Minnesota’s Medical assistance program) have been an important and leading part of our fight from the very beginning of our campaign to form a union. their stories have informed our policy and contract demands, and have moved legislators to understand that low pay and no benefits for home care workers creates instability and constant challenges in the lives of home care consumers.

the bill we advocated for and passed at the state capitol in 2013 explicitly maintained consumers’ rights to hire and fire their home care workers. While pay and benefits are set by the state, consumers need control over their own care. We were proud to have home care consumers join us in pushing for our right to organize, and we continue to include consum-ers in leadership roles as we negotiate our first contract.

Many people end up taking care of family members out of necessity. if home care work-ers miss work because they can’t afford to take the bus or leave for a better paying job, family members may be forced to step into the caregiver role to prevent their loved ones from entering an institution. the same situation occurs if a consumer has only six or eight hours of care available per

Unionizing home health care

How both providers and patients benefit

By sumer spika

Read usonlineWherever you are!

www.mppub.com


day, but needs more than that to live independently. often, these family caregivers end up working 24 hours a day, leave jobs with benefits, and become underpaid caregivers.

if the home care profession was compensated in a way that made sense, given the importance of the services we provide to seniors and people with disabilities, then consum-ers would have more stability in their care. Families would know that the workers caring for their loved ones will not only be there every day, but will have a deeper knowledge of the care their clients need.

What our union meanseight other states have es-tablished home care worker unions, and over the years they have seen their pay and working conditions improve. consumers also have reaped the benefits of having a more stable, professional workforce. When illinois home care work-ers first organized in the 1980s, many of the workers made $1 an hour; now the minimum wage for the state’s home care workers is over $13. in the state of Washington, many union workers are now making $15 an hour. and in multiple states, home care workers have won affordable health insurance. We are confident that as workers see the gains we are bargaining for, we will see a decrease in the incredibly high turnover rate that plagues our field here in Minnesota.

the recent U.s. supreme court ruling in harris vs. Quinn made home care unions “open shops.” every one of the home care workers in our bargaining unit will receive the benefits of the contract, but only workers who have signed cards will pay dues and be members. We already have thousands of members who have signed cards to be part of the union, and our support level has remained high from workers and consumers at every step of this campaign. as workers talk to each other and recognize the systemic prob-lems facing our field, they get

fired up about supporting and joining our union.

even before we won the right to vote on forming a union, two extreme anti-worker lobbying groups filed federal lawsuits to stop us. however, we are confident our union will not be weakened by these outlandish attacks. Both in

Minnesota and across the country, anti-union groups re-cruited a handful of home care workers to use in their attacks on workers’ collective bargain-ing. But that has not stopped workers and consumers from coming together to improve the conditions in our field. We don’t expect any of the attacks to derail our movement, especial-ly as we are able to see gains made through bargaining our first contract.

The future outlookMany of us have been involved in this struggle for more twists and turns than we care to re-member, but we have remained unwavering in our belief that we will win this fight to im-prove our industry. our goal has remained unchanged from the first days of this campaign over a decade ago: We want to make sure that our work is “invisible no more!”

We know from other states that better pay and working conditions leads to more stabil-ity, and we fully expect that to happen in Minnesota as well. especially when we consider the coming age wave, and the fact that home care work is pro-jected to be the second fastest growing job in the country for the next couple of decades, we don’t feel like we have much of a choice but to win this battle.

home care consumers will attest to the challenge of finding stable care, and as baby boomers age and want to stay in their homes, these challeng-

es will only compound. Many seniors and people with dis-abilities would already say we have a crisis, but this will only spread in future years if we don’t find a way to respect and invest in home care work. Most people want to stay in their homes, and that saves money for the state compared with

long-term care facilities. it is a win-win situation.

For myself and other home care workers, we want to be able to continue to do the work we love, yet it is imperative that we are able to provide for our own families. i’ve seen too many wonderful caregivers leave the field to do other work, not because they were not talented or caring, but because

they couldn’t afford rent or time off when they were sick.

it has been a powerful expe-rience for home care workers to come out from the shadows and talk to each other, recognizing that the daily challenges we face are frighteningly common. We know our first contract won’t change the industry over-night, but we know we will be moving in the right direction.

We appreciate all of the peo-ple who work hard in the med-ical field, and we simply hope the important role home care workers play in supporting mil-lions of people across the coun-try will finally be recognized and compensated fairly here in Minnesota. When at long last this happens, both home care workers and the people they serve will finally be able to live the lives they choose.

Sumer Spika is a home care worker and executive board member for SEIU Healthcare Minnesota.

We want to make sure that our work is “invisible no more!”

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NEUROLOGY

Vision and mild traumatic

brain injuryA look at the consequences

By Jessica Schara, OD


Vision is controlled in over 30 areas of the brain. Vision is different than

eyesight. Where eyesight is a measurement of acuity, vision is extremely complex and involves visual processing in the brain. seventy percent of all sensory processing in the human body is affected by vision. Because the brain is such an integral component of vision, it should come as no surprise that up to 40 percent of patients with mild traumatic brain injury (mtBi) complain of visual symptoms.

according to the centers for Disease control and Prevention, about 1.7 million people sustain a traumatic brain injury (most of which are mild) in the U.s. every year. this is likely an underestimation because some concussions go undiagnosed or are underreported. Despite the fact that some patients exhibit the signs and symptoms of mtBi and are unable to func-tion at work or school, imag-ing often shows no structural

injury. yet something is clearly wrong. current theories sup-port the fact that brain injury symptoms likely arise from diffuse axonal injury, whether it is to the axon itself or from altered cellular transport or metabolism from the injury. treatment modalities vary but cognitive brain rest allows the altered metabolism in the brain to heal. any increase in cogni-tive or physical activity places more demands on the already metabolically altered and ener-gy-lacking brain and will likely worsen symptoms. Recovering

from mtBi may take a few days or a few weeks. if symptoms last longer, patients may develop post-concussion syndrome, which refers to concussion symptoms that linger for weeks or even months after the injury.

Visual symptomsVision can be disrupted via pathway signaling disruption or by direct damage to the structures involved. as an optometrist, i have seen struc-tural issues related to mtBi such as retinal detachment and dry eye syndrome that

are important to address and treat. More often, i encounter patients who have refractive error changes (that may or may not resolve over time) and visual efficiency problems that make functional vision such as reading, using a computer, and driving much more difficult or impossible. if the eyes and the brain are not working together properly (teaming, focusing, and tracking all at the proper time), the concussed brain must expend energy (which it already lacks because of the mtBi) to try and fix the problem. as a result, reading automaticity and comprehension can be laborious. the importance of conducting a comprehensive eye and vision exam on all mtBi patients may play a significant role in recovery. in my practice, the majority of mtBi patients exhibit some visual symptoms. common symptoms and signs of mtBi include blurred vision at distance, blurred vision at near (more common), fluctua-tions in vision, pain around the

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eyes, headaches (usually frontal and severe), words appearing to move when reading, double vision, light sensitivity, the need to close or cover an eye, squinting, losing your place when reading, and rereading for comprehension. Patients often exhibit head tilts or turns and coordination issues, and will bump into objects due to visual field defects or have to hold on to the wall when walking. Diz-ziness when reading, problems judging size and distance, visual midline shift syndrome, staring behavior, poor balance, and nausea with near work activities are often observed as well. it’s important to remember that every mtBi patient is different.

Probably, the most frequent complaint from mtBi patients is that they have blurred near vision. Many patients report that their eyes feel tired, blurry, or hurt when trying to read or view a near object. the near reflex consists of pupils con-stricting, eyes turning inward

(converging), and the accommo-dative (focusing) system becom-ing stimulated. in my experi-ence, because these components are all interrelated, if one part isn’t functioning properly, the others may not be functioning

appropriately either. the ciliary muscle controls lens changes that cause our accommodative system to keep vision clear when shifting focus at varying distances. it has both sympa-thetic and parasympathetic innervation in which the signal-ing seems disrupted due to the autonomic dysfunction experi-enced by mtBi patients, thus causing symptoms. treatment for accommodative dysfunction includes the use of spectacles for near vision, bifocals, and

may include orthoptics/vision therapy. convergence and divergence binocular teaming issues are also prevalent, most commonly, convergence insuf-ficiency. convergence insuffi-ciency can cause symptoms of

diplopia, eye strain, dizzi-ness, head-aches, covering an eye while reading, and poor com-prehension. treatment of

this condition includes orthop-tics or vision therapy, lenses, and prisms in spectacles.

Eye movementthere are two main types of eye movements that seem to be affected in mtBi patients: pur-suit movements and saccades. Pursuit eye movements are used to track a moving object and are not only important in sports but also in reading. the pathway for pursuits involves the frontal eye fields to the

pontine nuclei to the vestibu-lar nuclei and finally ends at the oculomotor nuclei. While testing, if there seems to be a large variation in response in different directions that usually means that the frontal eye field on the ipsilateral (same) side is affected. saccades are fast, fine eye movements that occur when our eyes look from one place to the next, such as while reading. saccadic pathways occur from the frontal eye fields to the superior colliculus to the paramedian pontine reticular formation to the oculomotor nu-clei. Patients with pursuit and/or saccadic dysfunction experi-ence frequent loss of place when reading, may need to use their finger as a guide, reread text for comprehension, and skip words or lines. Brain injury patients may exhibit pursuit dysfunc-tion, saccadic dysfunction, and sometimes both. this is an in-efficient visual system and can have significant impact on qual-


About 1.7 million people sustain a traumatic brain

injury in the U.S. every year.

Vision and mild traumatic brain injury to page 30

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Vision and mild traumatic brain injury from page 29

ity of life. treatment options include spectacle correction if necessary and possibly vision therapy.

Diplopiastrabismus and decompensated phoria can all lead to diplo-pia after mtBi. Patients that once had good control of their strabismus prior to mtBi may not have the same ability after the injury. Many times, simple application of a prism can be very successful in eliminating patient symptoms during the healing process. Fresnel prisms are useful in that they can be applied to a patient’s glasses when they are in the office. as the patient heals, if the prism is decreased, a simple replace-ment with the lesser prism can be applied without having to remake the lenses. if the prism is not an option, patching may be necessary to ease diplopia. Patching limits a patient’s pe-

ripheral vision, which may lead to mobility issues and decreased depth perception. intractable diplopia patients may benefit from spot patching, which es-sentially looks like a small piece (less than the size of a dime) of scotch tape that is placed in the center of fixation of the patient’s glasses thereby allowing periph-eral vision to remain intact.

PhotophobiaPupil size can be influenced by the autonomic system and can dilate when in fight or flight mode allowing more light in, thereby making photopho-bia worse. this may not fully explain light sensitivity after mtBi. Photophobia/light sen-sitivity usually improves with time, however, patients can be made much more comfortable with tinted lenses for outdoor and indoor use. specifically, i have found that amber tints and gray or blue tints are successful in relieving patient symptoms.

Visual field defectsVisual field defects are a com-mon sequelae of mtBi. this causes peripheral vision issues that may in turn affect mobil-ity and cause patients to bump into objects or fall. in the office, peripheral vision testing plays an important role in manag-ing mtBi patients. Visual field defects can adversely affect reading. For example, a patient with right hemianopsia will be missing part of their field of vision on the right side of each eye and will stop reading a line of text too soon. a patient with left hemianopsia will have diffi-culty starting a line of text when reading. Boundary marking at the beginning or at the end of a column of text can help patients who lose their place when reading. Working with a therapist who teaches scanning techniques and expanding the field of vision with prisms may also be of benefit.

ConclusionMany patients recover from mtBi with brain rest treat-ment. For those who take longer to recover or who may have post-concussion syndrome, consider vision issues as a possi-ble culprit in delayed healing. i have had the most success treating patients when physi-cians and physical or occupa-tional therapists share infor-mation. mtBi patients have many issues that can compli-cate recovery and these issues must be addressed so they can return to work, school, or play. strong communication between providers gives the patient the best chance for a quick and full recovery.

Jessica Schara, OD, is an optome-trist at Mead EyeCare & EyeWear in Woodbury. She completed a residency in pediatrics and binocular vision and is a member of the Neuro-Optomet-ric Rehabilitation Association. She currently serves as a trustee on the Minnesota Optometric Association board.

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ments based on the specific genetic changes within a cancer have been developed in recent years. For example, mutations in the BRAF gene are associated with melanoma. Dabrafenib and related drugs are active against melanoma tumors with a specific BRAF mutation.

Treatment directed toward mutant or altered gene products are available for dis-ease other than cancer. For example, one drug has been developed to treat a subset of cystic fibrosis in patients with a specific genetic alteration in the gene responsible for this disease.

The importance of family historyUntil genomic-based drug therapy becomes a standard of

care and is readily available, clinicians should continue to use detailed family health his-tories to personalize health care delivery. A good family health history includes three genera-tions of biological relatives, the age at diagnosis of various con-ditions, and the age at death for deceased relatives. Patients can be directed to the Surgeon Gen-eral’s electronic family health

history tool to prompt them to collect necessary information. Family history information should be updated regularly. Genetic counselors are a great resource to collect family health history information and to counsel patients.

Where can I go for more information?There are a number of rep-utable websites that contain accurate, up-to-date informa-tion regarding genomics. This is a rapidly developing field with new results coming out daily.

• National Human Genome Research Institute, Na-tional Institutes of Health (NIH) (www.genome.gov)

is responsible for genomics research. Their site has information for patients as well as for researchers and clinicians.

• The Surgeon General’s Family Health History Ini-tiative site (www.hhs.gov/familyhistory/) contains information about Na-tional Family History Day, declared by the Surgeon General as Thanksgiving Day since 2004, and a link to My Family Health Portrait, an online family health history tool.

• The Centers for Disease Control and Prevention–Office of Public Health Genomics (OPHG) (www.cdc.gov/genomics/) pro-vides timely and credi-ble information for the effective and responsible translation of genomics research into population health benefits.

• The Food and Drug Ad-ministration site (www.fda.gov/Drugs/ScienceRe search/ResearchAreas/Pharmacogenetics/default.htm) has genomics infor-mation and includes the table of approved drugs with pharmacogenomic information on their label-ing.

• The National Society of Genetic Counselors site (www.nsgc.org) explains how to find a genetic coun-selor and learn about the services they provide.

• The American Cancer Society site (www.cancer.org) has cancer-specific information about genetic causes and gene-based therapies for cancers.

• The American Heart As-sociation site (www.heart.org) has information about the genetic basis of heart disease and treatment.

• The Genetic Alliance (www.geneticalliance.org) is a nonprofit health advocacy organization and their site has information on a wide range of genetics topics.

• Pharmacogenetic Research Network (PGRN) is funded by the National Institutes of Health and is a resource (www.pharmgkb.org) for the latest pharmacogenet-ics research results and evidence-based guidelines for genetic-based prescrib-ing.

• The American Medical Association site has a page (www.ama-assn.org/ama/pub/physician-resources/medical-science/genet ics-molecular-medicine/current-topics/pharmaco- genomics.page) that discusses pharmaco- genomics.

Ken Dornfeld, MD, PhD, is a radi-ation oncologist at Essentia Health in Duluth. His research interests include laboratory research into interactions between drugs and radiation and clinical research in breast cancer. Catherine A. McCarty, PhD, MPH, is a principal research scientist and director of the Research Division at Essentia Institute of Rural Health. She is currently conducting genomic med-icine and family health history studies funded by the National Institutes of Health.

32 MINNeSOTA PHySICIAN APril 2015

Pharmacogenetics from page 25

The ultimate goal is to use genetic information to tailor drug therapy.

MAYO CLINIC HEALTH SYSTEM is a family of clinics, hospitals, and other health care facilities serving over 70 communities in Minnesota, Iowa, and Wisconsin. Sharing Mayo Clinic’s primary value of “the needs of the patient come first,” Mayo Clinic Health System links the expertise of Mayo Clinic in practice, education, and research with the health-delivery systems of our local communities. Today, more than 1000 physicians practice in the health system. Mayo Clinic offers a highly competitive compensation package, which includes exceptional benefits, and has been recognized by FORTUNEmagazine as one of the “100 Best Companies to Work for.”The Northwest Wisconsin Region opportunities include:Dermatology Occupational MedicineEmergency Medicine Orthopedic Surgery (General,

Hand, Adult Reconstruction)Family Medicine PediatricsGeneral Surgery Psychiatry (Adult & Child)Hospitalist Pulmonary/Critical CareInternal Medicine Urgent CareNeurology Urology

Mayo Foundation is an affirmative action and equal opportunity employer and educator.

If you wish to learn more or to express interest in these positions,please contact us at 800-573-2580; email

[email protected]; or apply athttp://www.mayoclinic.org/jobs/physicians-scientists


Sioux Falls VA Health Care System

Sioux Falls VA HCS, SD

(605) 333-6852 www.siouxfalls.va.gov

Applicants can apply online at www.USAJOBS.gov

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.

CardiologistEndocrinologistENT(part-time)

Emergency MedicineGeriatrician (part-time)

Hospitalist (Internal Medicine or Family Practice)

NephrologistOncologist

Orthopedic SurgeonPhysician Assistant (Mental Health)

PodiatristPrimary Care (Family Practice or Internal Medicine)

PsychiatristPulmonologistUrologist (part-time)

Join the Leader in Correctional Health Care FEDERAL BUREAU OF PRISONS

Full-Time Psychiatrist – FMC Rochester, MN Full Time Clinical Director – FCI Sandstone, MN

Learn more at: www.bop.gov

www.glacialridge.org

Family or Internal Medicine Physician

An ideal balance between your professional and personal life. Provide comprehensive care in a clinical and hospital practice. ER coverage available, but not required.

GRHS is a progressive 19 bed Critical Access Hospital with two clinics. Glenwood is a family oriented community with an excellent school system. Recreational opportunities include boating, hiking, excellent fishing and hunting. We are halfway between Fargo and the Twin Cites.

For more informationCall Kirk Stensrud, CEO320.634.4521

Mail CV to:Kirk Stensrud, CEO10 Fourth Ave SEGlenwood, MN 56334

Email CV to:[email protected]

Join our teamAt Allina Health, we’re here to care for the millions of patients we see each year throughout Minnesota and western Wisconsin.

From rural to urban settings, you’ll find a practice and community that is right for you, with ideal staff support and the widest range of clinical practice options, physician leadership opportunities and competitive benefits.

Make a difference. Join our award-winning team.

1-800-248-4921 (toll-free) [email protected]

allinahealth.org/careers

EOE/AA/Vet/Disabled Employer

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• Workwithkeycommunitystakeholderstoimprovethecontinuumofcareandidentifygapsincare

Data integrationAcomprehensiveneedsas-sessmentwasdoneanditwasdeterminedthatoneoftheareasofopportunityforhealthoutcomeimprovementwasindataintegration.AlloftheWil-dernessmembersuseelectronichealthrecords(EHR),butnoneofthehospitalshaveasystemwiththeabilitytointerfacewithpayerdatafeedstoiden-tifycareperformedthroughoutthecontinuumoranalyzetotalcostofcareforpatients.Im-provingdataintegrationforonefacilitywasnotfeasibleduetocost,resourceavailability,andvolume.

Thecollaborativeiscur-rentlyworkingwithavendortoimplementananalyticaltoolthatallowsintegrationof

datafrommultiplesourcestoquicklyandefficientlyidentifyqualityimprovementsandbet-termanagepatientcarecoordi-nation.Thistoolwillenablethecollaborativeto:

• Monitorqualityacrosstheorganizations

• Identifyopportunitiestopositivelyimpactpatients’

healthandenhancecarecoordinationacrosshealthsystems

• Performpredictivemodel-ingtoidentifypatientsatriskofchronicconditions

Thecollaborativewillbeabletomonitorthetotalcost

ofcareandenableparticipa-tionwithMedicare,Medicaid,andcommercialpayeralterna-tivepaymentmodels.Healthsystemsandphysiciansacrosstheregionwillworktogethertodevelopconsistentbestmedicalpractices,enablingcoordinated,patient-centered,efficient,andhighqualitycare.

WildernessHealthreceivedaneHealthDevelopmentGrantfromtheMinnesotaDepart-mentofHealthinOctober2014.Thisgrantisbeingusedtofundaprojectmanagementplanforthedataintegrationproject.Theplanningprocessisex-pectedtowrapupinJune2015,

withsystemimplementationtooccurthroughout2015andprobably2016.

Onceimplemented,thesys-temwillenablethecollabora-tivetomeettheadditionalgoalofexpandingaccesstoandim-provingthequalityofessentialhealthcareservices.Monitor-ingqualityrequirestheability

tomeasureresultsandweknowthatweneedbettertoolstodothis.

WildernessHealthMedicalDirectorG.DavidSpoelhof,MD,describeshisvisionforWildernessHealthas,“Wehopetouseourshareddatatoiden-tifyopportunitiesfor

enhancedcaremanagement,resultinginbetterhealthout-comesanddecreasedcostsforourpatients.”

Cassandra Beardsley is executive director of Wilderness Health and serves on the Health Industry Advisory Panel for MNsure.

Wilderness Health from page 21

34 MInnESOTAPHySIcIAnApril 2015

Medicare is the largest payer for all Wilderness Health members.

Physician Practice Opportunities

www.averamarshall.org

For details on these practice opportunities go to http://www.avera.org/marshall/physicians/For more information, contact Dave Dertien, Physician Recruiter, at 605-322-7691 • [email protected]

Avera Marshall Regional Medical Center is part of the Avera system of care. Avera encompasses 300 locations in 97 communities in a five-state region. The Avera brand represents system strength and local presence, compassionate care and a Christian mission, clinical excellence, technological sophistication, an array of specialty care and industry leadership. Currently we are seeking to add the following specialists:

• Psychiatrist• Psychologist• Orthopedic Surgeon• General Surgeon

• Family Medicine• Internal Medicine• OBGYN

Avera Marshall Regional Medical

Center300 S. Bruce St.

Marshall, MN 56258


Olmsted Medical Center, a 220-clincian 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:

Send CV to: Olmsted Medical Center Human Resources/Clinician Recruitment

210 Ninth Street SE, Rochester, MN 55904

email: [email protected]: 507.529.6748 • Fax: 507.529.6622

www.olmstedmedicalcenter.org

Family MedicineSpring Valley Clinic

Nursing Home PhysicianRochester and Southeast MN

OB/GYNHospital – New Women’s

Health Pavilion

Pain MedicineRochester Northwest Clinic

Psychiatrist – Child & Adolescence

Rochester Southeast Clinic

•Allergy/Immunology

•Dermatology

•EmergencyMedicine

•FamilyMedicine

•GeneralSurgery

•GeriatricMedicine

•Hospitalist

•Hospice

•InternalMedicine

•Med/Peds

•Ob/Gyn

•OrthopedicSurgery

•PainMedicine

•Psychiatry

•Rheumatology

•SportsMedicine

Tell them there’s a better way!Get your patients

screened for colorectal cancer.

to leveraging new technology to improve the health of all Minnesotans. E-health is a critical component of advancing the notion of accountable health, in that it supports the safe, accurate, and efficient exchange of information between the care teams. E-health will play a piv-otal role in achieving our health system’s transformation to one that utilizes information and collaboration to continu-ally improve population health by providing the tools needed

to gather and use information. Building off of Minnesota’s strong history of collaboration among health care organiza-tions, this “learning health

system” will encompass a con-tinuous cycle of learning and improvement that optimizes information for research, pub-lic health surveillance, quality improvement, and consumer’s

knowledge-driv-en decision making. Achiev-ing a learning health system will enable health care in Minnesota to move beyond

the goals of the Triple Aim to truly transform the health and well-being of our citizens.

Health care providers are

embracing e-health to improve overall population health. Adoption rates are high for clinics and effective use of EHRs for patient care has increased over time. Progress is still underway to achieve the benefits and promise of fully interoperable EHRs in Minne-sota. However, the providers in the state are well positioned for success because of their commitment to health IT (HIT) and the collaborative efforts of the health care community. As

EHR systems and workforce HIT skills evolve, health care providers in Minnesota will be positioned to use HIT tools to optimize patient care and

outcomes, and to engage patients to be partners in their health care.

Resources for achiev-ing the 2015 Interoperable EHR Mandate are avail-able at: www.health.state.mn.us/e-health/

Bob Johnson, MPP, is a planner with the Minnesota Department of Health’s Office of Health Information Technology. He supports programs that advance the adoption and effective use of EHRs and other health information technology statewide and coordinates the work of the Minnesota e-Health Advisory Committee and the Privacy and Security Workgroup. Karen Soderberg, MS, is health infor-mation technology assessment & eval-uation coordinator with the Minnesota Department of Health’s Office of Health Information Technology. She coordinates and directs the statewide informatics profile of adoption, the use of EHRs, and the secure exchange and interoperability of health information.

36 MInnEsoTA PHysIcIAn APril 2015

Nine in 10 clinics and all Minnesota hospitals have adopted an EHR.

leveraging information technology from page 19

• Electronicprescribing

• Publichealthtransactions

• Laboratorydatatransactions

• Qualityreportingtransactions

• Transferofcareandreferralsummaries

Common HIE transactions

Urgent Care

We have part-time and on-call

positions available at a variety of Twin

Cities’ metro area HealthPartners

Clinics. We are seeking BC/BE full-

range family medicine and internal

medicine pediatric (Med-Peds)

physicians. We offer a competitive

salary and paid malpractice.

For consideration, apply online at

healthpartners.com/careers and

follow the Search Physician Careers link

to view our Urgent Care opportunities.

For more information, please contact

[email protected]

or call Diane at: 952-883-5453;

toll-free: 1-800-472-4695 x3. EOE

healthpar tners .com© 2014 NAS(Media: delete copyright notice)

MN Physician4" x 5.25"4-color

For additional information, contact Dr. Kathy Brandli, President, at [email protected] or

Eric Nielsen, Administrator, at [email protected] or 218.485.2000

www.gatewayclinic.com

Physician-owned Gateway Clinic seeks a family medicine physician to join our new Hinckley clinic. 3 or 4-day week practice with shared hospital call. Full-scope primary care and clinic OB practice (prenatal and postpartum care in clinic, option for colleagues to cover OB call and deliveries). Generous salary with sign-on and retention bonus, outstanding benefit package, 15% retirement contribution. Shareholder opportunities available.Gateway Clinic has locations in Moose Lake, Sandstone and Hinckley. Centrally located between Mpls/St. Paul and Duluth, the area provides an excellent family focused, quality of life opportunity in a rural setting with good public schools and abundant with lakes, rivers, state parks, and ideal hunting - all within an hour to metropolitan conveniences.

Family Medicine with Clinic OB


Please contact or fax CV to:

Joel Sagedahl, M.D.5700 Bottineau Blvd., Crystal, MN 55429

763-504-6600 Fax 763-504-6622

www.NWFPC.com

Join the top ranked clinic

in the Twin CitiesA leading national consumermagazine recently recognizedour clinic for providing the bestcare in the Twin Cities based on quality and cost. We are currently seeking new physicianassociates in the areas of:

• Family Practice

• Urgent Care

We are independent physician-owned and operated primaryclinic with three locations in theNW Minneapolis suburbs. Work-ing here you will be part of anaward winning team with partner-ship opportunities in just 2 years. We offer competitive salary andbenefits. Please call to learn howyou can contribute to our innova-tive new approaches to improvinghealth care delivery.

Opportunities for full-time and part-time staffare available in the following positions:

US Citizenship required or candidates must have proper authorization to work in the U.S. Physician applicants should be BE/BE. Applicant(s) selected for a position

may be eligible for an award up to the maximum limitation under the provision of the Education Debt Reduction

Program. 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, [email protected] Resources

4801 Veterans Drive, St. Cloud, MN 56303

(320) 255-6301

• Associate Chief of Staff

• Compensation & Pension Physician

• Dermatologist• Geriatrician/Hospice &

Palliative Care• Internal Medicine/

Family Practice

Applicants must be BE/BC.

• Medical Director - Extended Care & Rehab (Geriatrics)

• Ophthalmologist• Physician (Pain Clinic)/

Panel Management• Psychiatrist

Family Medicine & Emergency Medicine Physicians

• ImmediateOpenings• Casualweekendoreveningshiftcoverage• Setyourownhours• Competitiverates• PaidMalpractice

Great Opportunities

763-682-5906|[email protected]

www.whitesellmedstaff.com


people age. Dental practices can provide limited health screen-ings, education, and possibly follow-along services to their patients. as in the case of Dr. Rinaldi’s patient, it makes sense for dentists to be another line of defense for their patients’ over-all health and a partner to their primary physician.

the flaw in this system is that physicians do not have access to the data that dentists collect. conversely, unless a pa-tient volunteers health-related information during a dental vis-it or is asked, dentists are often unaware of any new medical issues they might have.

the obvious solution would be for dentists and doctors to be able to share all their patients’ dental and medical records. such a system does not cur-rently exist. With the advent of electronic medical and dental records, this could one day become a reality. however,

both physicians and dentists need to collaborate in order to build a shared electronic record system.

The future of dental/medical collaborationalthough there is ample oppor-tunity for the dental and med-ical professions to collaborate, so far only the surface has been scratched.

awareness is an important first step. While today’s dental instructors at the University of Minnesota and elsewhere now train their students about the oral and overall health connection, Park Dental has taken recent steps to further the dialogue by hosting an annu-al forum on current strategic health care issues for dental students. February’s event featured speakers from den-tistry and medicine and several gave keynote presentations and participated in a panel discussion about the oral/over-all-health connection. George J.

isham, MD, Ms, senior fellow with healthPartners institute for education and Research, discussed his role in working with his organization’s senior management team to improve patient care. his participation on the panel prompted some great interaction among the other panel members, dentists, and the dental students in at-tendance.

Park Dental recently em-barked on a new initiative called Vision 2030. this 15-year effort will help us increase our interaction with our patients’ physicians, as well as increase our focus and ability to mea-sure outcomes of care. through these efforts, we hope to elevate Minnesota’s oral health to become the best in the nation, a ranking in which the state currently falls short.

technology will certainly play an important role in over-coming the challenges currently faced in medical/dental col-laboration. system developers

have made incredible strides in today’s electronic medical and dental records. With support and guidance from the medical and dental communities, true interoperability between these records will one day be possible.

in his recent essay “Market trends in Dentistry,” Jeffrey R. Lavers wrote, “the dental care system will evolve more in the next 20 years than in the previous 50.” the same can probably be said for medicine. this evolution should include a much closer working relation-ship between dentists and phy-sicians. Research has already demonstrated that a medical/dental collaboration could be an important key in controlling rising health care costs. the ul-timate goal, however, is for phy-sicians and dentists to advance the overall health and quality of life of their patients.

John E. Gulon, DDS, is president and a board member of Park Dental, where he has been a practicing dentist since 1987.

Forging new alliances from page 17

Experience the future of Patient Engagement!The nGage Health Patient Relationship Management platform provides a proactive, real-time view of the health issues affecting your patients.

The nGage Health Platform provides physicians with a clear and meaningful view of self-reported data, enabling them to keep more detailed and current health records and form a more interactive relationship with their patients.

For more information about our free trial offer.612.326.6520 | [email protected] | www.ngagehealth.com900 American Boulevard East, Suite 241 | Bloomington, MN 55420

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is looking for primary and specialty physicians who want to help create a cure for the common coverage.

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Physicians, are you SIcK of: Feeling like you work for insurance companies instead of patients?Declining reimbursements while your patients pay higher premiums?Hospitals dictating where you refer patients?Patients delaying or avoiding much needed care because of high deductibles?

At MMIC, we believe patients get the best care when their doctors feel confi dent and supported. So we put our energy into creating risk solutions that everyone in your organization can get into. Solutions such as medical liability insurance, physicianwell-being, health IT support and patient safety consulting. It’s our own quiet way of revolutionizing health care.

To join the Peace of Mind Movement, give us a call at 1.800.328.5532 or visit MMICgroup.com.

Looking for a better wayto manage risk?

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minnesota physician april 2015

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