ensuring the safe use of insulin pens in the hospital ... · 9/4/2014 · ensuring the safe use of...

Ensuring the Safe Use of Insulin Pens in the Hospital:

Role of the Pharmacist

Presented as a Live Webinar

Thursday, September 4, 2014 1:00 p.m. – 2:00 p.m. EDT

http://onepenonepatient.org/webinar/safety

Planned and conducted by ASHP Advantage

Supported by an educational grant from Novo Nordisk Inc.


Ensuring the Safe Use of Insulin Pens in the Hospital: Role of the Pharmacist

Activity Overview

To ensure the safe use of insulin in hospitals, pharmacists need effective tools and ongoing education on insulin safety. This activity will review best practices for the use of insulin in managing hyperglycemia in hospitalized patients, including the use of insulin pens. Strategies that pharmacists can use to facilitate the safe and appropriate use of insulin pens in the hospital will be explained.

Learning Objectives

At the conclusion of this knowledge-based educational activity, participants should be able to

Discuss the importance of best practices for the use of insulin in the hospital, taking into account currentrecommendations and guidelines.

Compare the advantages and disadvantages of pen delivery systems with traditional vial and syringemethods of delivering insulin in the hospital setting.

Outline a plan for identifying and addressing potential safety issues related to the use of insulin pendelivery systems in hospitals.

Continuing Education Accreditation

The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 1.0 hour (0.1 CEU – no partial credit) of continuing pharmacy education credit (ACPE activity #0204-

0000-14-495-L05-P for the live activity and ACPE activity #0204-0000-14-495-H05-P for the on-demand activity).

Participants will process CPE credit online at http://elearning.ashp.org/my-activities, with the option of printing

a CE certificate. CPE credit will be reported directly to CPE Monitor. Per ACPE, CPE credit must be claimed no

later than 60 days from the date of a live activity or completion of a home study activity.

Webinar Information

Visit http://onepenonepatient.org/webinar/safety to find

Webinar registration link

Group viewing information and technical requirements

CPE webinar processing information

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http://elearning.ashp.org/my-activities



Activity Faculty

Mark F. Lutz, Pharm.D., CPPS Drug Information Specialist Beaumont Hospital Royal Oak, Michigan

Mark F. Lutz, Pharm.D., CPPS, is Drug Information Specialist at Beaumont Hospital in Royal Oak, Michigan. At this site, he serves as preceptor for the drug information and medication safety rotations in the postgraduate year 1 (PGY1) residency. He is also preceptor for the medication safety learning experience for the PGY2 residencies in pharmacy administration and critical care. In addition, Dr. Lutz serves as adjunct faculty for three colleges of pharmacy in Michigan: University of Michigan, Ferris State University, and Wayne State University.

Dr. Lutz earned his Doctor of Pharmacy degree from University of Michigan College of Pharmacy in Ann Arbor and completed a PGY1 residency accredited by the American Society of Health-System Pharmacists (ASHP) at William Beaumont Hospital. He is a board-certified professional in patient safety through the Certification Board for Professionals in Patient Safety.

Within the three-hospital Beaumont Health System, Dr. Lutz is involved in several committees and initiatives related to his practice interests of medication safety, drug formulary management, and decision support. He has taken the lead role in a multidisciplinary evaluation of inpatient insulin pen safety and implementation of system safety improvements. He also is a patient safety first responder on the patient safety response team.

Dr. Lutz is a member of ASHP, Michigan Pharmacists Association, and Michigan Society of Health-System Pharmacists (MSHP). He currently serves on the MSHP Pharmacy Technology and Informatics Task Force.

Paul M. Szumita, Pharm.D., BCPS Clinical Pharmacy Practice Manager Director, Critical Care Pharmacy Residency Brigham and Women’s Hospital Boston, Massachusetts

Paul M. Szumita, Pharm.D, BCPS, is Clinical Pharmacy Practice Manager at Brigham and Women’s Hospital (BWH) in Boston, Massachusetts. He also is Director of the postgraduate year 2 critical care pharmacy residency.

Dr. Szumita earned a Doctor of Pharmacy degree at Northeastern University in Boston, and he is a board-certified pharmacotherapy specialist.

At BWH, Dr. Szumita has helped develop and is responsible for managing clinical programs aimed at optimizing pharmacotherapy and improving patient outcomes. As a former Clinical Specialist and current practicing clinical pharmacist in critical care, he has an active role in bedside education, clinical research, and guideline development and implementation with a focus on glucose management, pain management for critically ill patients, agitation and delirium, hemodynamics in shock states, and inpatient glycemic management. He is co-chair of the hospital’s diabetes committee.

Dr. Szumita is an Adjunct Assistant Professor of Pharmacy at three colleges and helps coordinate 15 clinical rotations, training more than 100 students each year. He serves on several committees focused on improving clinical practice at the local and national level and has more than 25 peer-reviewed publications.

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Disclosure Statement

In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Guidelines for Standards for Commercial Support, ASHP Advantage requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A commercial interest is any entity producing, marketing, re‐selling, or distributing health care goods or services consumed by, or used on, patients. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g., employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on presentations.

All faculty and planners for ASHP Advantage education activities are qualified and selected by ASHP Advantage and required to disclose any relevant financial relationships with commercial interests. ASHP Advantage identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity.

Stuart T. Haines, Pharm.D., BCPS, BCACP, Planner, declares that he has served as a consultant for SanofiUSA and has divested himself of this relationship.

All other faculty and planners report no financial relationships relevant to this activity.

Additional Educational Opportunities and Resources

Live Ask the Experts webinar on November 12, 2014 (1 hour CPE)

Discussion guide (1 hour CPE)

Resource center: Compilation of guidelines, articles, and useful web sites

Tool kit: Sample policies and procedures, assessment tools, and educational resources

Web‐based version of this activity for colleagues who missed today’s webinar (1 hour CPE, available

November)


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Paul M. Szumita, Pharm.D., BCPSBrigham and Women’s HospitalBoston, Massachusetts

Mark F. Lutz, Pharm.D., CPPSBeaumont HospitalRoyal Oak, Michigan

Disclosures

• Stuart T. Haines, Pharm.D., BCPS, BCPS,BCACP, Planner, declares that he has served asa consultant for Sanofi USA and has divestedhimself of this relationship

• All other faculty and planners report no financialrelationship relevant to this activity

Learning Objectives

• Discuss the importance of best practices for theuse of insulin in the hospital, taking into accountcurrent recommendations and guidelines

• Compare the advantages and disadvantages ofpen delivery systems with traditional vial andsyringe methods of delivering insulin in thehospital setting

• Outline a plan for identifying and addressingpotential safety issues related to the use of insulinpen delivery systems in hospitals

Hospitalizations Account for Largest Portion of Direct Cost of Diabetes Care

• 2012 Total direct cost: $176 billion– 43% related to inpatient care

• Prevent admission and readmissions– Transitions of care– Ambulatory care

• Decrease cost of care in the hospital– Decrease morbidities

• Length of stay• Infections

American Diabetes Association. Diabetes Care. 2013; 36:1033-46.

Approximately what percentage of patients have hyperglycemia on admission (regardless of known diabetes status)?

a. 10%

b. 20%

c. 30%

d. 40%

Hyperglycemia Is Prevalent at Hospital Admission

• 38% of patients at admission havehyperglycemia

– Of those patients, nearly one third have nohistory of diabetes

Umpierrez GE et al. J Clin Endocrinol Metab. 2002; 87:978-82.

• Single-center, retrospective chart review of 1886 patients hospitalized over 15 weeks in community teaching hospital

• Hyperglycemia defined as BG 126 mg/dL on admission or while fasting, or random BG 200 mg/dL on 2 occasions

5

Guidelines from Professional Organizations on ICU Blood Glucose (BG) Goal

Year OrganizationPatient

Population

BG Treatment Threshold

(mg/dL)

BG Target

(mg/dL)

BG Hypoglycemia

Definition(mg/dL)

Updated since NICE-

SUGAR, 2009

2009 AACE and ADAICU patients

180 140–180 <70 Yes

2013Surviving Sepsis Campaign

ICU patients

180 <180Not stated

Yes

2009Institute for Healthcare Improvement

ICU patients

180 <180 <40 Yes

2012American College of Critical Care Medicine (ACCM)

ICU 150

<150 (Trauma)

<180(Stroke+)

<70 Yes

2013American College of Physicians

ICU patient Not stated 140–200 Not stated Yes

2008American Heart Association

ICU patients with ACS

180 90–140Not stated

No

Kavanagh BP et al. N Engl J Med. 2010; 363:2540-6.Qaseem A et al. Ann Intern Med. 2011; 154:260-7.

Jacobi J. Crit Care Med. 2012; 40:3251-76.Finfer S et al. N Engl J Med. 2009; 360:1283-97.

IV Insulin in the ICU Setting

Jacobi J. Crit Care Med. 2012; 40:3251-76.Moghissi ES et al. Diabetes Care. 2009; 32:1119-31.

Antihyperglycemic Therapy

InsulinRecommended

Oral Antidiabetic DrugsNot generally recommended

IV Insulin

Critically ill patients in the ICU

SC Insulin

Non-critically ill patients

Leuven I Leuven II VISEP Glucontrol NICE SUGAR

ICU SICU MICUSepsis Mixed

ICUMixed Mixed

Centers 1 1 18 19 42

Sample size 1548 1200 488/537 1011 ~6030

Diabetic ~13% ~17 ~30% ~19% ~20%

Excluded 14 863 1,612 ? 34,067

Stopped early No No Yes Yes No

Primary diet TPN 85% TPN 85% 60% TPN 27% TPN 25% TPN

APACHE II ~9 ~23 ~20 ~15 ~21

MortalityICU: ~ 7%

Hos: ~10%

ICU: ~25%

Hos: ~40%28 Day: ~27%

ICU: ~16%

Hos: ~22%28 Day: ~21%

HypoglycemiaIIT: 5%

Control: 2%

IIT: 18.7 %

Control: 3.1%

IIT: 17%

Control: 4.1 %

IIT: 9.8

Control: 2.7%

IIT: 6.8 %

Control: 0.5%

Protocol Leuven Leuven Leuven Variable ? NICE

Target (mg/dL) 80-110 80-110 80-110 80-110 81-108

Control (mg/dL) < 180 < 180 < 180 140-180 144-180

Timing ICU admit ICU admit < 12 hrs ? < 24 hrs

Duration ICU stay ICU stay ICU/ 21 days ICU or 56 daysEating or 90

days

van den Berghe G et al. N Engl J Med. 2001; 345:1359-67; van den Berghe G et al. N Engl J Med. 2006; 354:449-61; Brunkhorst FM et al. N Engl J Med. 2008; 358:125-39;

Preiser JC et al. Intensive Care Med. 2009; 35:1738-48; Finfer S et al. N Engl J Med. 2009; 360:1283-97.

IIT = intensive insulin therapy

Mortality in RCTs Targeting 80-110 mg/dL

4.8

24.2 24.7

16.7

27.5

8

26.8 25.6

15.2

24.9

0

5

10

15

20

25

30

LeuvenSICU*

LeuvenMICU*

VISEP** Glucontrol* NICE-SUGAR***

Mo

rtal

ity

Rat

e (%

)

Intensive Control

P < 0.04

P = 0.31 P = 0.5 P = 0.02P = 0.74

* ICU** 28 day*** 90 day

van den Berghe G et al. N Engl J Med. 2001; 345:1359-67; van den Berghe G et al. N Engl J Med. 2006; 354:449-61; Brunkhorst FM et al. N Engl J Med. 2008; 358:125-39; Preiser JC et al.

Intensive Care Med. 2009; 35:1738-48; Finfer S et al. N Engl J Med. 2009; 360:1283-97.

Hypoglycemia in RCTs Targeting 80-110 mg/dL

5

18.7

17

9.8

6.8

23.1

4.12.7

0.50

2

4

6

8

10

12

14

16

18

20

Leuven SICU Leuven MICU VISEP Glucontrol NICE-SUGAR

% P

atie

nts

Intensive ControlHypoglycemia defined < 40 mg/dL

van den Berghe G et al. N Engl J Med. 2001; 345:1359-67; van den Berghe G et al. N Engl J Med. 2006; 354:449-61; Brunkhorst FM et al. N Engl J Med. 2008; 358:125-39; Preiser JC et al.

Intensive Care Med. 2009; 35:1738-48; Finfer S et al. N Engl J Med. 2009; 360:1283-97.

All variables P < 0.001

Hypoglycemia and Mortality: Australian Database Analysis

Bagshaw SM et al. Crit Care Med. 2009; 37:463-70.

Hypoglycemia Incidence HospitalMortality (%)

Adjusted OR(95% CI)*

None 92.9% 15.7% 1.0

< 73 mg/dL 6.2% 29.5% 1.5 (1.3-1.6)

< 40 mg/dL 0.9% 57.4% 2.6 (2.1-3.2)

*Covariate adjustment for age, sex, surgical status, primary diagnosis, comorbid illness, APACHE II, mechanical ventilation, acute kidney injury, and hospital site

• Database analysis of 24 Australian ICUs• 66,184 adult ICU admissions for >24 hr from January 1, 2000 – December 31, 2005

Similar trends seen when patients were stratified by MICU, SICU, CT ICU, and sepsis

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See enlargement p. 16


Guidelines from Professional Organizations:BG Goals in Non-critically Ill Patients


PopulationTreatment Threshold Target

BG Definition of

Hypoglycemia

Updated since NICE-

SUGAR

2009 AACE and ADA Consensus Statement


180 mg/dL

Premeal<140 mg/dL

<70 mg/dL(Reassess treatment if <100 mg/dL)

Yes

2012 Endocrine Society Clinical Practice Guideline


180 mg/dL

Premeal <140 mg/dL

(Reassess treatment if <100 mg/dL)

Yes

Moghissi ES et al. Endocr Pract. 2009; 15:353-69.Umpierrez GE et al. J Clin Endocrinol Metab. 2012; 97:16-38.

Examples of Poor Outcomes Related to Hyperglycemia During Hospitalization

Study Patient PopulationSignificant Hyperglycemia-related

Outcomes

Pasquel et al. 2010

Total parenteral nutrition (TPN)

Mortality risk, pneumonia risk, acute renal failure

Frisch et al. 2010

Noncardiac surgery Mortality risk, surgery-specific risk

Schlenk et al. 2009

Aneurysmal subarachnoid hemorrhage

Mortality riskImpaired prognosis

Bochicchioet al. 2007

Critically injured trauma patients

LOS, mortality risk, ventilator time, infection

Baker et al. 2006

Chronic obstructive pulmonary disease (COPD)

LOS, mortality risk, adverse outcomes

McAllister et al. 2005

Community acquired pneumonia

LOS, mortality risk, complications

Pasquel FJ et al. Diabetes Care. 2010; 33:739-41; Frisch A et al. Diabetes Care. 2010; 33:1783-8; Schlenk F et al. Neurocrit Care. 2009; 11:56-63; Bochicchio GV et al. J Trauma. 2007; 63:1353-8;

Baker EH et al. Thorax. 2006; 61:284-9; McAllister et al. Diabetes Care. 2005; 28:810-5.

Admission and Change in Glucose Within 24 Hours Predict Mortality Risk

*Multivariate analysisAMI=acute myocardial infarction

Change in BG (24-hr vs baseline)≥30 mg/dL drop in BG <30 mg/dL drop in BG Actual increase in BG

Goyal A et al. Eur Heart J. 2006; 27:1289-97.

N=1469 with AMI (n=1219 without diabetes)

0

2

4

6

8

10

12

30

-Da

y m

ort

ali

ty (

%)

Baseline Blood Glucose (mg/dL)<125 125 to <140 140 to <170 ≥170

9% in 30-day mortality per 10 mg/dL decrease in BGin first 24 hr (P=.002)*

Hyperglycemia: An Independent Marker for In-Hospital Mortality in Patients withOR WITHOUT Established Diabetes

0

10

20

30

Total In-patient Mortality

Normoglycemia Known NewDiabetes Hyperglycemia

1.7% 3.0%

16.0%*

Mo

rtal

ity

(%)

*p < 0.01Umpierrez GE et al. J Clin Endocrinol Metabol. 2002; 87:978-82.

What is the preferred method tomanage hyperglycemia in thenon-ICU inpatient acute care setting?

a. Home regimen

b. Insulin sliding scale

c. Basal, nutritional, correctional insulin

d. Regularly scheduled basal insulin

Antihyperglycemic Therapy

Basal/Nutritional SC Insulin

Recommended for most medical-surgical patients

Non-insulinNot generally recommended

Continuous IV InfusionSelected medical-surgical

patients

Pharmacological Treatment of Hyperglycemia in Non-ICU Setting

Moghissi ES et al. Diabetes Care. 2009; 32:1119-31.Umpierrez GE et al. J Clin Endocrinol Metabol. 2012; 97:16-38.

Smiley D et al. J Hosp Med. 2010; 5:212-7.

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Estimating Initial Insulin Regimen

Clement S et al. Diabetes Care. 2004; 27:553-91.

Estimate total daily dose (TDD) ~ 0.2-0.5 units/kg/day

~50% TDD BASAL

Give ~50% TDD NUTRITIONAL

Maintaining Physiologic Insulin Delivery in the Hospital: Basal Bolus

Breakfast Lunch Dinner Bedtime

Insu

lin Normal secretory

pattern of insulin

Hirsch IB. N Engl J Med. 2005; 352:174-83. EL4, review.

Correction or supplemental insulin

Basal insulin

RABBIT 2: Glycemic Control with Basal-Bolus vs. Sliding-Scale Insulin

Umpierrez GE et al. Diabetes Care. 2007; 30:2181-6.

*P<0.01; †P<0.05; ‡Long-acting insulin (glargine) once daily + short-acting insulin (glulisine) before meals, total dose 0.4 unit/kg (BG 140-200 mg/dL) or 0.5 unit/kg (BG 201-400 mg/dL).

N=130 insulin-naïve hospitalized nonsurgical patients with T2DM

Blo

od

glu

cose

(m

g/d

L)

240

220

200

180

160

140

120

1001Admit 2 3 4 5 6 7 8 9 10

†

†

††***

Sliding-scale

Basal-bolus‡

Switched from sliding-scale to

basal-bolus insulin

Days of therapy

Admit 1 2 3 4 1 2 3 4 5 6 7100

140

180

220

260

300

n=9 with BG >240 mg/dL

RABBIT 2 = Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management ofPatients with Type 2 Diabetes.

Achievement of Glucose Goals

Outcomes and Hypoglycemia

Percent of Patients with BG <140 mg/dL

55%

31%

0%

20%

40%

60%

80%

100%

Scheduled Basal

Bolus

Sliding Scale

P < 0.001

Hospital Complications*

BG <70 mg/dL

BG <40 mg/dL

Basal bolus

8.6% 23.1% 3.8%

Sliding scale

24.3% 4.7% 0%

P value 0.003 < 0.001 0.057

*Composite of postoperative complications,including wound infection, pneumonia, bacteremia, respiratory, and acute renal failure

Basal-Bolus vs. Sliding Scale Insulin in RABBIT 2 Surgery Study


Glycemic Control in Hospitals in the United States

Swanson CM et al. Endocr Pract. 2011; 17:853-61.

32.2 32

6.3 5.7

0

5

10

15

20

25

30

35

ICU Non-ICU

Hyperglycemiaprevalence (>180mg/dL)

Hypoglycemiaprevalence (<70mg/dL)

Total of 49,191,313 (12,176,299 ICU, 37,015,014 non-ICU) POC-BG measurements were obtained from 3,484,795 inpatients (653,359 in ICU and 2,831,436 in non-ICU areas)

Pa

tien

t d

ays

(%)

Current Recommendations for Hospitalized Patients

• All critically ill patients in intensive care unit settings– BG level absolutely below 180 mg/dL and perhaps less than 150

mg/dL– BG greater than 150 mg/dL should be a trigger to consider

treatment– Intravenous insulin preferred

• Non–critically ill patients– Random: < 180 mg/dL and pre-meal < 140 mg/dL– Scheduled SC insulin preferred– Sliding-scale insulin discouraged

• Hypoglycemia– Reassess the regimen if BG level is < 100 mg/dL – Modify the regimen if BG level is < 70 mg/dL

Jacobi J et al. Crit Care Med. 2012; 40:3251-76. Moghissi ES et al. Endocr Pract. 2009;15:353-69.

Umpierrez GE et al. J Clin Endocrinol Metab. 2012; 97:16-38.

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Enhancing Insulin-use Safety in Hospitals:Practical Recommendations from ASHPFoundation Expert Consensus Panel

• Ten insulin-use safety recommendations– Recommendation 7: Hospitals must

» Develop policies and procedures to ensure insulin pensused for individual patients only

» Establish policies and educational programs to ensure safe use of insulin pens and disposable needle tips

– Discussion

» Pens can be used safely if proper policies, procedures, and staff education are in place

» Technology solutions need to be developed to ensure thatinsulin pens are not used for more than one patient

Cobaugh DJ et al. Am J Health-Syst Pharm. 2013; 70:1404-13.

Insulin Pen Advantages

• Cost savings

• Improved dose accuracy

• Satisfaction

• Convenience

• Ease of administration

Insulin Pen Advantages - Cost

• Potential for cost savings– Lower healthcare utilization rates

– Hypoglycemia-related• Ambulatory setting

– Potentially reduce waste• Particularly if using patient-specific 10-mL insulin

vial

Pisupati R et al. Hosp Pharm. 2009; 44:871-3; Davis EM et al. Hosp Pharm. 2013; 48:396-405; Meece J. Am J Health-Syst Pharm. 2008; 65:1076-82;Asche CV et al. Diabetes Technol Ther. 2010; 12(Suppl 1):S101-8;

Lee WC et al. Clin Ther. 2006; 28:1712-25; Ward LG et al. Am J Health-Syst Pharm. 2011; 68:1349-52; Lee LJ et al. Am J Health-Syst Pharm. 2012; 69:958-65.

Administration – Pen vs. Vial/Syringe

• Attach pen needle

• Prime using air shot

• Use dial to selectappropriate dose

• Inject

• Keep needle in skin

Pen

• Inject air into vial

• Draw up dose into syringe

• Remove air (tap & prime)

• Inject

• Keep needle in skin

Vial/Syringe

Insulin Pen Advantages – Improved Dose Accuracy

• Improved dose accuracy– Easy-to-read dial

• Visual and audio dose

– Less likely to draw up an inaccurate dosecompared with vial and syringe

– No “10-fold or 100-fold” errors seen with vialand syringe, particularly when drawn up withnon-insulin syringe

Meece J. Am J Health-Syst Pharm. 2008; 65:1076-82.Lee WC et al. Clin Ther. 2006; 28:1712-25.

Asche CV et al. Diabetes Technol Ther. 2010; 12(Suppl 1):S101-8.

Insulin Pen Advantages - Satisfaction

• Satisfaction– Patients prefer them

• Increase patient confidence and adherence

– Healthcare providers prefer them• Physicians

• Nurses

Davis EM et al. Hosp Pharm. 2013; 48:396-405. Davis EM et al. Diabetes Educ. 2009; 35:799-809.

Davis EM et al. Am J Health-Syst Pharm. 2008; 65:1347-57.Korytkowski M et al. Clin Ther. 2003; 25:2836-48.

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Insulin Pen Advantages – Convenience

• Convenience and ease of administration– Ready-to-use

• Decrease preparation time

– Perhaps eliminate nursing double check

Meece J. Am J Health-Syst Pharm. 2008; 65:1076-82.

Pen Disadvantages vs. Vial/Syringe

&Plan for Improving Pen Safety

In the Inpatient Setting

Inpatient Expense: Pens vs. Vials

• Direct costs– Insulin

• Pen > vial/syringe on “per mL” basis

– Injection• Pen needle > syringe

• Waste - it all depends!– Vials (3mL or 10mL), pens (3mL), or pre-drawn dose?

• If vials, floor stock or individual patient supply?

Davis EM et al. Hosp Pharm. 2013; 48:396-405.Davis EM et al. Am J Health Syst Pharm. 2008;65:1347-57.

Lee LJ et al. Am J Health-Syst Pharm. 2012; 69:958-65.

Insulin Pens for Everyone?

• Most available in pens– Rapid acting

• Aspart, glulisine, lispro

– Isophane suspension

– Basal• Detemir, glargine

– Mixes• 70% Aspart protamine suspension / 30% aspart

• 75% Lispro protamine suspension / 25% lispro

• 50% Lispro protamine suspension / 50% lispro

• 70% Isophane suspension / 30% regular

• But not all– Insulin regular (U-100)

– Insulin regular (U-500)**Prefilled pen designed to deliverinsulin regular U-500 is underdevelopment.

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (accessed 2014 Jul 26). Lilly USA, LLC, Medical Division. Personal Communication. May 30, 2014.

ISMP Newsletter Acute Care Edition. October 13, 2013.

Technique is Important

• Improper priming– Correct: 2 unit “air shot” before each injection

– Reason• Avoids injection of air

• Ensures delivery of proper dose

ISMP Newsletter Acute Care Edition. May 8, 2008.Grissinger M. P & T. 2011; 36:615-6.

Mitchell VD et al. Diabetes Educ. 2012; 38:651-8.


• Failure to “tip & roll” pen suspensions..........10 then 10!– Isophane suspension

– 70% Isophane suspension / 30% regular

– 70% Aspart protamine suspension / 30% aspart

– 75% Lispro protamine suspension / 25% lispro

– 50% Lispro protamine suspension / 50% lispro

• Result = clumps and uneven distribution


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• Incorrect administration technique errors– Use of pens as a multidose vial can introduce

air and result in inaccurate dose delivery

– Not advised unless emergency or penmalfunction

Cohen MR. Am J Health-Syst Pharm. 2010; 67(16 Suppl 8):S17-21. Grissinger M. P & T. 2010; 35:245, 266.

Grissinger M. P & T. 2011; 36:615-6.


• “What’s that wet spot?”– Residual amount from priming?

– Partial dose?

– Early removal = insulin stream = lost dose*Manufacturer recommendations vary

Insert needle into

skin

Press & hold down

dose button

Keep needle in skin 5-10 seconds*


Mitchell VD et al. Diabetes Educ. 2012; 38:651-8.


• Needlestick injuries– Risk with both pens and vials/syringes

– Pens• Failure to hold at 90° angle may pierce patient,

then fingers of person giving injection

• Difficult visualization may contribute

• Automatic needle safety covers help preventneedlestick after injection

Davis EM et al. Am J Health-Syst Pharm. 2008; 65:1347-57.Grissinger M. P & T. 2011; 36:615-6.

Insulin Pen Disadvantages

• Bloodborne infection transmission risk– HIV, hepatitis B, hepatitis C

An insulin pen is intendedfor use in ONE patient only

– Evidence for biological contamination

– Misuse in healthcare settings

– Warnings, recommendation, and information

Biologic Contamination of Insulin Pens

Le Floch JP et al. Diabetes Care. 1998; 21:1502-4.Sonoki K et al. Diabetes Care. 2001; 24:603-4.

Herdman ML et al. Am J Health-Syst Pharm. 2013; 70:1244-8.

Author Methods Results Conclusion

Le Floch et al. (1998)

Pen needle & cartridge contents evaluated from 120 DM pts seen in French ambulatory clinic

Cartridge • Air bubbles: (45%)• Squamous and/or epithelial

cells: (58%)

Biologic material can be aspirated fromskin/SC tissue, through needle, into cartridge

Sonoki et al.(2001)

Pen cartridge contents evaluated from 146 DM pts in Japan

Hemoglobin: 6/146 (4.1%)• quantity > 0.3µl

Amount of blood in cartridges enough to transmit hepatitis B infection

Herdman et al. (2013)

Pen cartridge contents evaluated from 125 pens used in U.S. hospitalized patients

Biologic material: 7/125 (5.6%)• Hemoglobin• Squamous epithelial cells• Red blood cells• Macrophages

Potential exists for infection transmission if insulin pen used in multiple patients, even with needle changes

Healthcare Report of Pen Use in Multiple Patients

• WB Army Medical Center (El Paso,TX)

– January 30, 2009– RN reported misuse to superiors– 2113 patients potentially impacted (8/07–1/09)– Patient testing conducted; no clear evidence of

pathogen transmission– Reported to FDA and CDC– Nurse survey

• 74% reported receiving training for correct use• 24% believed use occurred in multiple patients

Hakre S et al. Mil Med. 2012;177:930-8.

11



FDA MedWatch Alert: Insulin Pens

Recommendation / Information FDA(3/19/2009)

Insulin pens are meant for use by a single patient only; and are not to be shared between patients

X

Identify pen with patient name and other identifiers X

Eject disposable needle from pen and properly discard after each injection; attach new needle before each new injection

X

Hospitals and other healthcare facilities should review policies and educate staff regarding safe use of pens

X

www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm133352.htm

(accessed 2014 Jun 20).

Insulin Pen Misuse Continues…..Date Location Impacted

Patients Contributing Factors

January 2009

WB Army Medical Center,El Paso, TX

2114(8/07-1/09)

RN disclosure of insulin pen use in more than one patient

August 2011

Dean Clinic, Madison, WI

2345(2006-2011)

RN certified as diabetes educator providing insulin pen training in clinics changed needle between

injections but reused pen

Hakre S et al. Mil Med. 2012; 177:930-8.http://www.deancare.com/about-dean/news/2011/important-patient-safety-notification/

(accessed 2014 Jun 20).

CDC “Clinical Reminder”Recommendation / Information FDA

(3/19/2009)CDC

(1/5/2012)


X X(even when

needle is changed)

Identify pen with patient name and other identifiers X X


X


X X

If pen reuse identified, promptly notify exposed persons to offer appropriate follow-up including bloodborne pathogen testing

X

http://www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html(accessed 2014 Jun 20).

Centers for Medicare & Medicaid Services• CMS (5/2012): Hospitals will be issued

citation if insulin pen sharing incidents areidentified– “Sharing of insulin pens is essentially the same

as sharing needles or syringes.”

– “…… must direct the surveyor to focus onoverall infection control practices in the facility.”

CMS Director, Survey and Certification Group. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-

12-30.pdf (accessed 2014 Jul 26).ISMP Newsletter Acute Care Edition. May 31, 2012.



January 2009

WB Army Med CenterEl Paso, TX

2114(8/07-1/09)


August 2011

Dean Clinic Madison, WI

2345(2006-2011)

Diabetes educator certified RNgave insulin pen training in clinics-

changed needle / reused pen.

January 2013

Buffalo VAMCBuffalo, NY

716(10/10-11/12)

Routine patient care unit inspection found insulin pens not labeled for

individual patients

January 2013

Olean GeneralOlean, NY

1915(11/09-1/13)


February 2014

South NassauOceanside, NJ

4247(3/11-1/14)

RN overheard saying pen use in more than one patient okay

May 2014

Griffin Hospital Derby, CT

3100(9/08-5/14)


ISMP Medication Safety Alert!

• “Ongoing concern about insulin pen reuseshows hospitals need to considertransitioning away from them”– Knowledge deficit regarding safe use more

widespread than initially thought

– Education, monitoring, punishing not fixes

“We believe that the risk is best mitigated by

removing insulin pens from use in inpatient settings.”

ISMP Newsletter Acute Care Edition. February 7, 2013http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=41 (accessed 2014 Jun 20).

12



ASHP Foundation Consensus Panel Recommendations

• 21-member multidisciplinary “expert” panel (8/2012) • Prioritized highest risk insulin errors by phase of care

– Administration phase: wrong doses; incorrect pen use

• Ten insulin-use safety recommendations– Recommendation 7: Hospitals must

» Develop policies and procedures to ensure insulin pens used for individual patients only

» Establish policies and educational programs to ensure safe use of insulin pens and disposable needle tips

– Discussion» Pens can be used safely if proper policies, procedures, and

staff education are in place » Technology solutions need to be developed to ensure that

insulin pens are not used for more than one patient

Cobaugh DJ et al. Am J Health-Syst Pharm. 2013; 70:1404-13.

• Outline a plan for identifying andaddressing potential safety issues relatedto the use of insulin pen delivery systemsin hospitals

Which of the following best describes your practice site with respect to insulin pens?

a. Hospital with inpatient pen use

b. Hospital without inpatient pen use

c. Other healthcare facility with pens

d. Other healthcare facility without pens

e. Other

Incorporating Safety Decisions in Formulary Management

1. Consider ADEs, preparation issues, look-alike and sound-alike potential, dosing & administration issues

2. Proactively assess high-risk medications or major system changesin med-use processes (FMEA)

3. Review medication-event and near-miss data to make recommendations to prevent future events

4. Perform quality improvement projects to improve safety of specificmeds and processes

5. Ensure policies address potential risk issues

6. Champion evidence-based techniques (i.e., bar-coding) to preventmedication events

7. Review external safety event reports to proactively identify ways to prevent medication events

ASHP guidelines: P&T committee & formulary system. Am J Health-Syst Pharm. 2008;65:1272-83.

Insulin Pen Safety - Where to Start?

• SQ insulin a “Top 10” high-alert medication– Heightened risk of causing significant patient harm

when used in error

• High-alert medication error reduction andsafe-use strategies– Reduce or eliminate possibility of error– Increase likelihood of detection

• What you don’t know CAN hurt patients!!!!

– Minimize consequences of errors

ISMP Newsletter Acute Care Edition. July 3, 2014.

Cohen MR. Medication errors. 2nd ed. 2007.

Healthcare Failure Mode and Effects Analysis

• Definition– Prospective, systematic approach to identify system

vulnerabilities and to make corrections before errorsoccur

• 5-Step process– Define topic– Assemble multidisciplinary team– Graphically describe the process– Conduct hazard analysis– Determine actions and outcome measures

DeRosier J et al. Jt Comm J Qual Improv. 2002; 28:248-67.

Stalhandske E et al. Pt Safety & Qual Healthcare. 2009; 30-33.

13

Medication Use ProcessSelection /

Procurement

Storage

Prescribing / Ordering

Preparing / Dispensing

Administering

Monitoring

Error Reduction Strategy Evaluation

• Select withprioritytowardthoserecognizedas beingmoreeffective

Adapted from: ISMP. Medication Safety Alert! Acute Care Edition. 2 Jun 1999; (4)11.

Preparing Insulin Pens

• Tamper-evident tape– Was the dispensed pen used?

– Not used?

– Can it be redispensed?

– Application method matters• Perpendicular to barrel/cap – NOT wrapped around

Preparing Insulin Pens

• Patient-specific labeling– Placement on pen

• Barrel, NOT pen cap

– Clearly visible patient identifiers• Name, medical record number, date of birth……

– Avoidance of extra baggie label• One patient’s pen in another patient’s baggie

Dispensing Insulin Pens

• Patient-specific location– Institutionally defined, secure

• Clearly defined process– Placement into patient-specific location by

pharmacy personnel

• NOT: “I’ll go ahead and tube that up.”

Administration with Insulin Pens

• Correct pen at bedside– Role of environment, workflow, and culture

• Easy to do correctly?

• Hard to do incorrectly?

• Correct administration technique

• Double check???

14

Administration with Insulin Pens

• Patient-specific labeling– Barcodes are NOT created equal

• Manufacturer’s barcode

• Order- or patient-specific barcodeHey! I’m the wrong pen!

Policies, Education, Information, and Reminders

• “One Pen, One Patient”, and why

• Initial orientation and ongoing training plan

• Maximize visibility to nurse– Pen label?

– eMAR?

Which insulin pen error reduction strategy is NOT correctly matched?

a. Dispensing process to pt-specific location = Standardization

b. Order-specific barcode = Fail-safe & constraint

c. Clear patient identifiers on label = Information

d. “One Pen, One Patient” on eMAR or pen label = Reminder

Determining Insulin Pen Safety Success

• Error report analysis

• Ask (or survey) frontline staff

• Conduct direct observations

• Monitor BCMA scanning compliance &“wrong-pen” alerts

Key Resource http://onepenonepatient.org/

• Education– CPE webinars and

discussion guide

• Resource center– External resources

– Articles and guidelines

• Tool kit– Sample

documents

– Outcomemeasures

ConclusionIn the inpatient setting: • Use of insulin for hyperglycemia management in

accordance with best practice guidelines canreduce morbidity and mortality

• Insulin pen and vial/syringe use are bothassociated with benefits and limitations

• Pharmacists can help ensure insulin pen safety– Implement high leverage error-reduction strategies

– Promote organizational “One Pen, One Patient”awareness

– Implement ongoing process monitoring & improvements

15

Guidelines from Professional Organizations on ICU Blood Glucose (BG) Goal


Population

BG Treatment Threshold

(mg/dL)

BG Target

(mg/dL)

BG Hypoglycemia

Definition(mg/dL)

Updated since NICE-

SUGAR, 2009

2009 AACE and ADAICU patients

180 140–180 <70 Yes

2013Surviving Sepsis Campaign

ICU patients

180 <180Not stated

Yes

2009Institute for Healthcare Improvement

ICU patients

180 <180 <40 Yes

2012American College of Critical Care Medicine (ACCM)

ICU 150

<150 (Trauma)

<180(Stroke+)

<70 Yes

2013American College of Physicians

ICU patient Not stated 140–200 Not stated Yes

2008American Heart Association

ICU patients with ACS

180 90–140Not stated

No

Kavanagh BP et al. N Engl J Med. 2010; 363:2540-6.Qaseem A et al. Ann Intern Med. 2011; 154:260-7.

Jacobi J. Crit Care Med. 2012; 40:3251-76.Finfer S et al. N Engl J Med. 2009; 360:1283-97.

Leuven I Leuven II VISEP Glucontrol NICE SUGAR

ICU SICU MICUSepsis Mixed

ICUMixed Mixed

Centers 1 1 18 19 42

Sample size 1548 1200 488/537 1011 ~6030

Diabetic ~13% ~17 ~30% ~19% ~20%

Excluded 14 863 1,612 ? 34,067

Stopped early No No Yes Yes No

Primary diet TPN 85% TPN 85% 60% TPN 27% TPN 25% TPN

APACHE II ~9 ~23 ~20 ~15 ~21

MortalityICU: ~ 7%

Hos: ~10%

ICU: ~25%

Hos: ~40%28 Day: ~27%

ICU: ~16%

Hos: ~22%28 Day: ~21%

HypoglycemiaIIT: 5%

Control: 2%

IIT: 18.7 %

Control: 3.1%

IIT: 17%

Control: 4.1 %

IIT: 9.8

Control: 2.7%

IIT: 6.8 %

Control: 0.5%

Protocol Leuven Leuven Leuven Variable ? NICE

Target (mg/dL) 80-110 80-110 80-110 80-110 81-108

Control (mg/dL) < 180 < 180 < 180 140-180 144-180

Timing ICU admit ICU admit < 12 hrs ? < 24 hrs

Duration ICU stay ICU stay ICU/ 21 days ICU or 56 daysEating or 90

days

van den Berghe G et al. N Engl J Med. 2001; 345:1359-67; van den Berghe G et al. N Engl J Med. 2006; 354:449-61; Brunkhorst FM et al. N Engl J Med. 2008; 358:125-39;

Preiser JC et al. Intensive Care Med. 2009; 35:1738-48; Finfer S et al. N Engl J Med. 2009; 360:1283-97.

IIT = intensive insulin therapy

16

Examples of Poor Outcomes Related to Hyperglycemia During Hospitalization

Study Patient PopulationSignificant Hyperglycemia-related

Outcomes

Pasquel et al. 2010

Total parenteral nutrition (TPN)

Mortality risk, pneumonia risk, acute renal failure

Frisch et al. 2010

Noncardiac surgery Mortality risk, surgery-specific risk

Schlenk et al. 2009

Aneurysmal subarachnoid hemorrhage

Mortality riskImpaired prognosis

Bochicchioet al. 2007

Critically injured trauma patients

LOS, mortality risk, ventilator time, infection

Baker et al. 2006

Chronic obstructive pulmonary disease (COPD)

LOS, mortality risk, adverse outcomes

McAllister et al. 2005

Community acquired pneumonia

LOS, mortality risk, complications

Pasquel FJ et al. Diabetes Care. 2010; 33:739-41; Frisch A et al. Diabetes Care. 2010; 33:1783-8; Schlenk F et al. Neurocrit Care. 2009; 11:56-63; Bochicchio GV et al. J Trauma. 2007; 63:1353-8;

Baker EH et al. Thorax. 2006; 61:284-9; McAllister et al. Diabetes Care. 2005; 28:810-5.

RABBIT 2: Glycemic Control with Basal-Bolus vs. Sliding-Scale Insulin


*P<0.01; †P<0.05; ‡Long-acting insulin (glargine) once daily + short-acting insulin (glulisine)before meals, total dose 0.4 unit/kg (BG 140-200 mg/dL) or 0.5 unit/kg (BG 201-400 mg/dL).

N=130 insulin-naïve hospitalized nonsurgical patients with T2DM

Blo

od

glu

cose

(m

g/d

L)

240

220

200

180

160

140

120

1001Admit 2 3 4 5 6 7 8 9 10

†

†

††***

Sliding-scale

Basal-bolus‡

Switched from sliding-scale to

basal-bolus insulin

Days of therapy

Admit 1 2 3 4 1 2 3 4 5 6 7100

140

180

220

260

300

n=9 with BG >240 mg/dL

RABBIT 2 = Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes.

17


• Incorrect administration technique errors– Use of pens as a multidose vial can introduce

air and result in inaccurate dose delivery

– Not advised unless emergency or penmalfunction

Cohen MR. Am J Health-Syst Pharm. 2010; 67(16 Suppl 8):S17-21. Grissinger M. P & T. 2010; 35:245, 266.

Grissinger M. P & T. 2011; 36:615-6.

Biologic Contamination of Insulin Pens

Le Floch JP et al. Diabetes Care. 1998; 21:1502-4.Sonoki K et al. Diabetes Care. 2001; 24:603-4.

Herdman ML et al. Am J Health-Syst Pharm. 2013; 70:1244-8.

Author Methods Results Conclusion

Le Floch et al. (1998)

Pen needle & cartridge contents evaluated from 120 DM pts seen in French ambulatory clinic

Cartridge • Air bubbles: (45%)• Squamous and/or epithelial

cells: (58%)

Biologic material can be aspirated fromskin/SC tissue, through needle, into cartridge

Sonoki et al.(2001)

Pen cartridge contents evaluated from 146 DM pts in Japan

Hemoglobin: 6/146 (4.1%)• quantity > 0.3µl

Amount of blood in cartridges enough to transmit hepatitis B infection

Herdman et al. (2013)

Pen cartridge contents evaluated from 125 pens used in U.S. hospitalized patients

Biologic material: 7/125 (5.6%)• Hemoglobin• Squamous epithelial cells• Red blood cells• Macrophages

Potential exists for infection transmission if insulin pen used in multiple patients, even with needle changes

18

CDC “Clinical Reminder”Recommendation / Information FDA

(3/19/2009)CDC

(1/5/2012)


X X(even when

needle is changed)

Identify pen with patient name and other identifiers X X


X


X X

If pen reuse identified, promptly notify exposed persons to offer appropriate follow-up including bloodborne pathogen testing

X

http://www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html(accessed 2014 Jun 20).



January 2009

WB Army Med CenterEl Paso, TX

2114(8/07-1/09)


August 2011

Dean Clinic Madison, WI

2345(2006-2011)

Diabetes educator certified RNgave insulin pen training in clinics-

changed needle / reused pen.

January 2013

Buffalo VAMCBuffalo, NY

716(10/10-11/12)

Routine patient care unit inspection found insulin pens not labeled for

individual patients

January 2013

Olean GeneralOlean, NY

1915(11/09-1/13)


February 2014

South NassauOceanside, NJ

4247(3/11-1/14)

RN overheard saying pen use in more than one patient okay

May 2014

Griffin Hospital Derby, CT

3100(9/08-5/14)


19


Self-assessment Questions

1. In patients with or without diabetes, inpatient hyperglycemia is an independent marker for

a. Pneumonia.b. Acute renal failure.c. Prolonged length of stay.d. In-hospital mortality.

2. Compared with sliding scale insulin, basal-bolus insulin therapy using insulin glargine once daily plus insulinglulisine before meals in general surgery patients with type 2 diabetes in the RABBIT 2 Surgery Study

a. Increased the risk of a composite of postoperative complications.b. Decreased the risk of a composite of postoperative complications.c. Increased the risk of hypoglycemia defined as blood glucose less than 40 mg/dL.d. Decreased the risk of hypoglycemia defined as blood glucose less than 70 mg/dL.

3. Which of the following is an advantage of insulin pens over vials and syringes?

a. Lack of need for priming.b. Greater dosing accuracy.c. Availability with needle already attached.d. Ability to use the same pen for multiple patients.

4. Which of the following statements about insulin pen use in the inpatient setting is correct?

a. Insulin pens are associated with lower cost and less waste than vials and syringes.b. Pens with suspensions must be rolled 10 times before every dose.c. Pen needles with safety covers prevent all needlesticks.d. Wet spot on skin may be priming volume or partial dose lost.

5. Which of the following organizations issued a statement that infection transmission risk associated withinpatient insulin pen use may be best mitigated by removing insulin pens from this setting?

a. Centers for Disease Control and Prevention.b. Centers for Medicare & Medicaid Services.c. Food and Drug Administrationd. Institute for Safe Medication Practices.

Answers

1. d2. b3. b4. d5. d

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