1. health and fitness
2. disease
3. diabetes

4/22/2015
Quality Improvement
Initiative and Safety of Insulin
Pen Usage in the Hospital
Mikayla Klug Pharm.D, RPh
PGY-1 Pharmacy Practice Resident
University of Montana – Community Medical Center
Disclosures Slide
IRB Status: Not Required
Co-investigators:
Kevin Cady, Pharm.D., Clinical Pharmacy Manager
Janice Tate, RN CDE, Diabetes Nurse Educator
Marcie Willmore, RN, Med/Surg Clinical Director
Theresa Horst RN , Coordinator, Quality and Risk Management
Stacey Rice, BSN, RN, Clinical Informatics Analyst of ICU,
Med/Surg, Ortho & RNU
Conflicts of Interest: none
Project Sponsorship:
ASHP 2014 Mentored Quality Improvement Impact Activity for
Insulin Pen Safety
Objectives
Apply the history of insulin pen devices to current
practices in the hospital setting
Describe insulin pen administration and proper
storage education to nurses within the inpatient
hospital.
Identify methods of improving insulin pen safety in
the hospital.
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History
NovoPen®, first insulin pen injector introduced in
1985 by Novo Nordisk
Advantages:
Convenience and discretion
Improved quality of life
Ease of use
Providers were more likely to recommend
Clin Drug Investig. 2010;30(10):643-74.
October 2004
Critically evaluate the method of insulin delivery
Scheduled doses of insulin be prepared by Rx for
immediate use or patient-specific delivery devices
(pens)
Remove all floor stock, multiple-use insulin, except
of regular insulin
ASHP: Recommendations for Safe Use of Insulin in Hospitals. October 2004.
November 30, 2006
Hospitals switching from 10 mL vials to 3 mL patient
specific insulin pens
Reports of medications errors in patients’ homes and
health care facilities
ISMP  safe practice guidelines
Reduce risk of serious errors
ISMP: Pen Injectors: Technology is not without impending risk. 11/30/2006
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May 8, 2008
30% of hospitals had transitioned to insulin pen devices
Advantages:
Labeled by manufacturer with product name and strength
Individually labeled with the patient's name
Ready for administration
Lessened time needed to prepare and administer insulin
Reduce medication waste
ISMP: Considering insulin pens for routine hospital use? Consider this… 5/8/2008
May 8, 2008
Problems encountered:
Needle stick injuries
User technique errors
Using pens like vials
Using a pen for multiple patients
Dispensing and administration errors
ISMP: Considering insulin pens for routine hospital use? Consider this… 5/8/2008
March 19, 2009
FDA issued an alert to healthcare professionals:
Insulin pens are for SINGLE PATIENT USE ONLY and NOT
TO BE SHARED
Inappropriate reuse and sharing of insulin pens continued…
FDA: Information for Health Care Professionals: Risk of Transmission of Blood-borne
Pathogens from Shared Use of Insulin Pens. 3/19/2009
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2009:
Texas hospital - 2,114 patients between 2007- 2009
potentially exposed
2011:
Wisconsin hospital & outpatient clinic >2,000
patients exposed
Contacted by hospital and offered hepatitis and HIV testing
Hepatitis C positive cases
FDA: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens. 3/19/2009
ISMP: Ongoing concern about insulin pen reuse shows hospitals need to consider transitioning
away from them. 2/7/2013
The Risk is REAL
Blood and tissue travel back into insulin pen cartridges
4.1% contained hemoglobin
6 of 146 cartridges
Diabetes Care. 2001; 24(3):603-4;
58% contained squamous cells and other epithelial cells
70 of 120 cartridges
Diabetes Care. 1998; 21(9):1502-4
ISMP: Ongoing concern about insulin pen reuse shows hospitals
need to consider transitioning away from them. 2/7/2013
February 7, 2013:
“As a result of ongoing issues with the
reuse of insulin pens on multiple patients,
we believe that hospitals should closely
reexamine the safe use of these pen
devices, with strong consideration given to
transitioning away from insulin pens for
routine inpatient use.”
ISMP: Ongoing concern about insulin pen reuse shows hospitals need
to consider transitioning away from them. 2/7/2013
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Purpose
Improve the performance of insulin pen delivery,
patient health, and reduce adverse effects related to
insulin pen use in the hospital setting
Impact of participation in the Mentored Insulin Pen
Safety Impact Initiative had on the appropriate use of
insulin pen devices in participating hospitals
Baseline Data
Outcomes Evaluation
Nurse Knowledge Assessment
Insulin Injection Observation
Insulin Pen Storage and Labeling Audit
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Methods
Nurse Knowledge Assessment
1.
Insulin pharmacokinetic profiles
2.
Situations when patient is at greatest risk for
hypoglycemia
3.
Advantages and risks of insulin pens hospitals
4.
Appropriately administered according to manufacturer’s
recommendations
5.
Stored in an appropriate location
Methods
Insulin Injection Observation Checklist
Methods
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Methods
Insulin Pen Storage and Labeling Audit
Results
Nurse Knowledge Assessment
5% response rate from all nursing personnel
Insulin administration time vs hypoglycemic events
Proper steps to insulin administration
Priming insulin pens
Holding for 5-10 seconds
Results
Table 1. Baseline Pen Administration: (n= 37)
# Step Descriptions
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Retrieves Insulin pen from hospital-approved patient-specific storage area
Expiration is documented on label
Obtains replacement pen if expiration date is not documented or if expired*
Displays use of proper hand hygiene prior to patient contact
Performs patient identification (according to hospital policy)
Checks medication label
Scans the patient's ID band and the insulin pen bar code (prospectively)*
Mixes insulin by gently tilting pen device back and forth 8-10 times or rolling in
palm of hands (NPH insulin only)*
Swabs rubber stopper with alcohol swab
Attaches new disposable needle onto the pen
Primes pen before injection (e.g., dials 2 units on the dose selector, points needle
up so bubbles are forced to top, and firmly presses plunger until drop of insulin
appears; repeat if needed)
Dials correct dose (e.g., based on patient-specific order)
Selects appropriate injection site (e.g., abdomen, back of arm, thigh)
Pinches fold of skin§ at the injection site, holds pen at 90 degree angle# to skin, and
inserts pen needle all the way into the skin
Lets go of skin fold and injects the entire dose of insulin
Keeps plunger pressed and holds against the skin for at least 5 seconds
Removes and discards needle in appropriate sharps container
Returns pen device to hospital-approved patient-specific storage area in a timely
manner (e.g., within 15 minutes)
Performed
69%
95%
33%
100%
100%
100%
100%
--78%
100%
81%
100%
100%
100%
100%
92%
100%
78%
* Not applicable (applies to only 3 steps in the process).
§ For 5mm BD mini needle, it is not necessary to pinch a skin fold.
# For children or very lean patients, a 45° angle is permissible if 8mm (5/16”) or 12.7mm (1/2”) length needle is used
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Results
Table 2. Baseline Storage and Labeling Audit (n=71)
Pt. Care
Area
Pens
Audited
Patient
Name
Active
Order
Storage per Properly
Policy
Labeled
Properly Stored
& Labeled
RNU/Ortho
24
(24) 100%
(17) 71%
(22) 92%
(24) 100%
(17) 71%
Med/Surg
23
(23) 100%
(21) 91%
(18) 78%
(21) 91%
(18) 78%
ICU
24
(23) 96%
(20) 83%
(15) 62%
(23) 96%
(13) 54%
Total
71
(70) 99%
(58) 82%
(55) 77%
(68) 96%
(48) 68%
Results
Improvement:
Policy & Procedure: Insulin Pen Use
New Pharmacy Insulin Pen Labeling
Diabetes Educator – Nursing Meetings
Nursing Continuing Education (CNE) = 1 hour
Yearly competencies (Healthstream)
Post-Intervention Data Collection
April 5th – May 1st, 2015
Outcomes Evaluation
Nurse Knowledge Assessment
Insulin Injection Observation
Insulin Pen Storage and Labeling Audit
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Conclusion
Community Medical Center has avoided the issue of
shared insulin pens
However, we will continue to hold to these results
with our new policies and procedures, nursing CE,
and yearly educational competencies.
Questions???
Contact Information:
Mikayla Klug
[email protected]
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