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Evaluation of calcitonin utilization in a tertiary healthcare setting Nicolas LaPlante, Pharm.D. Candidate, Bret LaForge, Pharm.D. Candidate, Matthew J. Marston, Pharm.D., BCPS Eastern Maine Medical Center, Bangor, Maine OBJECTIVES / PURPOSE RESULTS METHODS CONCLUSION DISCLOSURES INTRODUCTION Evaluate the prescribing patterns of calcitonin use Conduct a cost-savings analysis on potential benefits of order standardization Create a hospital-wide order set to govern future prescribing Calcitonin costs have increased dramatically in recent years, warranting a review of its prescribing patterns Currently, one vial costs $2,138.49 Calcitonin is a highly efficacious method for the acute treatment of hypercalcemia, while waiting for bisphosphonates to take effect (within 2-4 days after administration) 1 The serum calcium lowering effects of calcitonin are typically observed within 4 hours of administration, but use is limited due to tachyphylaxis after 48-72 hours 1,2 Calcitonin is commonly used inappropriately for the treatment of osteoporosis vertebral compression fractures (OCVF) and osteoporosis 3,4 Enforcing prescribing restrictions would result in considerable cost-savings for the hospital and patients without negatively impacting treatment efficacy Retrospective analysis for a 2.5 year period (01/01/2014 to 06/01/2016), was conducted for all patients with calcitonin orders Patients who received at least one dose were subdivided by means of the following indications: Hypercalcemia OCVF Osteoporosis Literature and guidelines were analyzed to determine appropriateness of indications and prescribing patterns Information was used to conduct a cost-savings analysis A hypercalcemia order set was developed to implement prescribing restrictions and encourage responsible calcitonin use Current literature and restrictions from other surveyed hospitals were used in the development of this order set, which limits calcitonin use to 72 hours and restricts it to severe cases of hypercalcemia The authors of this presentation have the following to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation: Nicolas LaPlante: Nothing to disclose, Bret LaForge: Nothing to disclose, Matthew Marston: Nothing to disclose RESULTS Indication Justifications Indication Literature/Guidelines Hypercalcemia Recommended for first 2-4 days for patients with corrected calcium levels of 12 mg/dL or greater OVCF Common analgesics should be used first-line for OVCF pain. Head-to-head study showed non- inferiority when compared to pamidronate 5 Osteoporosis Not recommended by FDA due to malignancy risk and lack of efficacy 6 Indication 48 Hours or Less >48 to 72 Hours Total Hypercalcemia 19 3 27 OVCF 7 1 10 Osteoporosis 1 0 1 Cost-Savings Analysis Results 48-hour restriction $39,480/year 72-hour restriction $32,760/year Number of Calcitonin Orders 68 Patients Who Received Medication 32 (47%) Orders Approved by Indication Hypercalcemia 24 (75%) OVCF 7 (22%) Osteoporosis 1 (3%) Proposed Order Set Information: Severe hypercalcemia (ionized calcium >2.5 mmol/L, Corrected calcium >14 mg/dL) Saline Hydration 0.9 % NS: 200 mL/hr Titrate 50 mL/hr every 4 hrs Maintain urine output at 100-150 mL/hr Zoledronic Acid 4 mg in 100 mL NS Administer IV over 15 minutes Creatinine must be < 4.5 mg/dL May redose if correct calcium remains > 12 mg/dL after 7 days Do not use if history of osteonecrosis of the jaw Calcitonin Dose: 4 IU/kg every 12 hrs MAX: 8 IU/kg every 6 hrs Pharmacy may round to nearest vial size Duration: MAX: 72 hrs Obtain new serum Ca 6 hrs after administration May increase dose if serum Ca has not decreased by > 1 mg/dL Laboratory Ionized Ca STAT, and every 6 hrs for first 24 hrs Ionized Ca every AM, after initial 24 hrs Telemetry Initiate if serum Ca > 12 mg/dL May discontinue if serum Ca falls below 12 mg/dL Activity Progressive, weight-bearing ambulation Dose Received by Indication Hypercalcemia OVCF Osteoporosis 0 5 10 15 20 25 30 48 hours or less > 48 to 72 hours Greater than 72 hours Treatment Duration Hypercalcemia OVCF Osteoporosis REFERENCES 1. Mirrakhimov AE. Hypercalcemia of Malignancy: An Update on Pathogenesis and Management. N Am J Med Sci. 2015;7:483-93. 2. Ralston SH. Medical management of hypercalcemia. Br J Clin Pharmacol. 1992;34:11-20. 3. Knopp JA, Diner BM, Blitz M, Lyritis GP, Rowe BH. Calcitonin for treating acute pain of osteoporotic vertebral compression fractures: a systematic review of randomized, controlled trials. Osteoporos Int. 2005;16:1281–1290. 4. Wells G, Chernoff J, Gilligan JP, Krause DS. Does salmon calcitonin cause cancer? A review and meta-analysis. Osteoporos Int. 2016;27:13–19 5. Laroche M, Cantogrel S, Jamard B. Comparison of the analgesic efficacy of pamidronate and synthetic human calcitonin in osteoporotic vertebral fractures: a double-blind controlled study. Clin Rheumatol. 2006;25:683-686. 6. U.S. Food and Drug Administration. Background document for meeting of Advisory Committee for reproductive health drugs and drug safety and risk management advisory committee. March 5, 2013. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM34177 9.pdf $62.74 $69.05 $69.29 $2,006.85 $2,321.14 $0.00 $500.00 $1,000.00 $1,500.00 $2,000.00 $2,500.00 2012 2013 2014 2015 2016 Cost - USD Year Medicare Part B – Oct’s Average Sales Price

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Page 1: Evaluation of calcitonin utilization in a tertiary … Spring Slides...Evaluation of calcitonin utilization in a tertiary healthcare setting Nicolas LaPlante, Pharm.D. Candidate, Bret

Evaluation of calcitonin utilization in a tertiary healthcare setting

Nicolas LaPlante, Pharm.D. Candidate,

Bret LaForge, Pharm.D. Candidate, Matthew J. Marston, Pharm.D., BCPS Eastern Maine Medical Center, Bangor, Maine

OBJECTIVES / PURPOSE RESULTS

METHODS

CONCLUSION

DISCLOSURES

INTRODUCTION

• Evaluate the prescribing patterns of calcitonin use • Conduct a cost-savings analysis on potential benefits

of order standardization • Create a hospital-wide order set to govern future

prescribing

• Calcitonin costs have increased dramatically in recent years, warranting a review of its prescribing patterns Currently, one vial costs $2,138.49

• Calcitonin is a highly efficacious method for the acute treatment of hypercalcemia, while waiting for bisphosphonates to take effect (within 2-4 days after administration)1

• The serum calcium lowering effects of calcitonin are typically observed within 4 hours of administration, but use is limited due to tachyphylaxis after 48-72 hours1,2

• Calcitonin is commonly used inappropriately for the treatment of osteoporosis vertebral compression fractures (OCVF) and osteoporosis3,4

• Enforcing prescribing restrictions would result in considerable cost-savings for the hospital and patients without negatively impacting treatment efficacy

• Retrospective analysis for a 2.5 year period (01/01/2014 to 06/01/2016), was conducted for all patients with calcitonin orders

• Patients who received at least one dose were subdivided by means of the following indications: Hypercalcemia OCVF Osteoporosis

• Literature and guidelines were analyzed to determine appropriateness of indications and prescribing patterns

• Information was used to conduct a cost-savings analysis

• A hypercalcemia order set was developed to implement prescribing restrictions and encourage responsible calcitonin use

• Current literature and restrictions from other surveyed hospitals were used in the development of this order set, which limits calcitonin use to 72 hours and restricts it to severe cases of hypercalcemia

The authors of this presentation have the following to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation: • Nicolas LaPlante: Nothing to disclose, Bret LaForge: Nothing to disclose, Matthew Marston: Nothing to disclose

RESULTS

Indication Justifications

Indication Literature/Guidelines

Hypercalcemia • Recommended for first 2-4 days for patients with corrected calcium levels of 12 mg/dL or greater

OVCF • Common analgesics should be used first-line for OVCF pain.

• Head-to-head study showed non-inferiority when compared to pamidronate5

Osteoporosis • Not recommended by FDA due to malignancy risk and lack of efficacy6

Indication 48 Hours or Less

>48 to 72 Hours

Total

Hypercalcemia 19 3 27

OVCF 7 1 10

Osteoporosis 1 0 1

Cost-Savings Analysis Results

48-hour restriction $39,480/year

72-hour restriction $32,760/year

Number of Calcitonin Orders 68

Patients Who Received Medication 32 (47%)

Orders Approved by Indication

Hypercalcemia 24 (75%)

OVCF 7 (22%)

Osteoporosis 1 (3%)

Proposed Order Set Information: Severe hypercalcemia (ionized calcium >2.5 mmol/L,

Corrected calcium >14 mg/dL)

Saline Hydration • 0.9 % NS: 200 mL/hr • Titrate 50 mL/hr every 4 hrs

Maintain urine output at 100-150 mL/hr

Zoledronic Acid • 4 mg in 100 mL NS Administer IV over 15 minutes

• Creatinine must be < 4.5 mg/dL • May redose if correct calcium remains > 12

mg/dL after 7 days • Do not use if history of osteonecrosis of the jaw

Calcitonin • Dose: 4 IU/kg every 12 hrs MAX: 8 IU/kg every 6 hrs Pharmacy may round to nearest vial size

• Duration: MAX: 72 hrs

• Obtain new serum Ca 6 hrs after administration May increase dose if serum Ca has not

decreased by > 1 mg/dL

Laboratory • Ionized Ca STAT, and every 6 hrs for first 24 hrs • Ionized Ca every AM, after initial 24 hrs

Telemetry • Initiate if serum Ca > 12 mg/dL • May discontinue if serum Ca falls below 12

mg/dL

Activity • Progressive, weight-bearing ambulation

Dose Received by Indication

Hypercalcemia

OVCF

Osteoporosis

0

5

10

15

20

25

30

48 hoursor less

> 48 to72 hours

Greater than72 hours

Treatment Duration

Hypercalcemia OVCF Osteoporosis

REFERENCES 1. Mirrakhimov AE. Hypercalcemia of Malignancy: An Update on Pathogenesis and Management. N Am J Med Sci. 2015;7:483-93. 2. Ralston SH. Medical management of hypercalcemia. Br J Clin Pharmacol. 1992;34:11-20. 3. Knopp JA, Diner BM, Blitz M, Lyritis GP, Rowe BH. Calcitonin for treating acute pain of osteoporotic vertebral compression fractures: a systematic

review of randomized, controlled trials. Osteoporos Int. 2005;16:1281–1290. 4. Wells G, Chernoff J, Gilligan JP, Krause DS. Does salmon calcitonin cause cancer? A review and meta-analysis. Osteoporos Int. 2016;27:13–19 5. Laroche M, Cantogrel S, Jamard B. Comparison of the analgesic efficacy of pamidronate and synthetic human calcitonin in osteoporotic vertebral

fractures: a double-blind controlled study. Clin Rheumatol. 2006;25:683-686. 6. U.S. Food and Drug Administration. Background document for meeting of Advisory Committee for reproductive health drugs and drug safety and risk

management advisory committee. March 5, 2013. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM341779.pdf

$62.74 $69.05 $69.29

$2,006.85

$2,321.14

$0.00

$500.00

$1,000.00

$1,500.00

$2,000.00

$2,500.00

2012 2013 2014 2015 2016

Co

st -

USD

Year

Medicare Part B – Oct’s Average Sales Price