BarTender® Software Case Study
EnglishLabeling for Insulin Pen Safety
Hospitals that dispense injection pens to administer insulin to inpatients face unusual labeling challenges. A pharmacy professional
used a solution that includes BarTender® label software to devise an innovative labeling system that improves patient safety.

The introduction of the injection pen in1985 made living with insulin-dependent
diabetes more manageable. Patients foundthe pen system, consisting of a cartridge anda disposable needle, easier to transport andadminister than the traditional vial and syringe.
The pens provided reliable, accurate dosing.

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However, with this advance inpharmaceutical technology came newchallenges for patient safety.

The challenge:
Safe insulin pen usage in hospitals
Although the pens were designed for patient
self-injection and at-home use, they also
became the method of choice for hospitals
to administer insulin at bedside, creating aunique set of problems.

Cross-contamination
When a vial and syringe is used to administer
insulin, the same vial could be used withmultiple patients. However, the cartridge ofan insulin pen is not the same as a vial.

“Even though the disposable needle isreplaced after each injection, intact humancells can travel though the needle and into
the cartridge during injection,” said Chuck
DiTrapano, RPh, the operations manager at
the pharmacy of a major US health facility.
Some hospitals did not recognize thisdifference and initially failed to limit a
cartridge’s use to one patient, leading
to cross-contamination. In March 2009,
the US Food and Drug Administration
responded to the problem with an alert thatmultiple-patient use of an insulin pen cantransmit disease. The FDA cited incidents
at two hospitals where shared use of insulin
pens potentially exposed an estimated2,000 patients to Hepatitis C and HIV,even though needles were changed after
each injection.
Even when a hospital does limit cartridge
use to one patient, cross-contamination
can occur due to simple human error, suchas when insulin pens are mixed up frompatient to patient at bedside.

Expiration dates

Identification best practices

All medications have an expiration date andrequire proper handling to ensure efficacy.
In the case of insulin pens, they must betransported from the pharmaceuticalmanufacturer and stored in the pharmacy
under refrigeration.

The Institute for Safe Medical Practices(ISMP) has defined strict best practices
for labeling. To protect patient safety, alabel must feature two forms of patient
identification, such as name and medical
record number, proper storage condition
information, proper drug ID informationand proper expiration date.

“Once a pen is removed from refrigerationand dispensed, its window of use changes,”
said DiTrapano. Unrefrigerated insulin
expires after anywhere from 7 to 42days (7, 14, 28, 30 or 42) when stored atroom temperature, depending on theproduct, product volume and brand, sothe pharmacist must calculate the newexpiration date and mark it on the pen when
it is dispensed.
To maintain patient safety, it is imperativethat a drug be used within its particular
window, but accurately managing the widevariety of use and disposal dates can becomplicated for a hospital staff.

Labeling considerations
Safe use of an insulin pen hinges on singlepatient use, clear patient identification,
and a room temperature expiration date on
the device.

The ISMP also advises a font strategy called
Tall Man lettering, which uniquely combines
upper- and lower-case characters to enableeasy differentiation and identification ofsimilarly named drugs, thereby helping
health care professionals avoid potentially
dangerous dosing mix-ups.

Impediments to labeling
Unfortunately, insulin pens are not easy to label.
“There are very expensive dispensing
software applications that can calculate
expiration and dose and print that
information on a label,” DiTrapano said,“but their label placement is inadequate—thepatient label can either be placed on theshaft of the pen, obscuring the product info,
or on the pen’s cap, and a nurse juggling two
pens can easily place the labeled cap on thewrong pen.”Also, the pen’s small diameter makes it
difficult to legibly print all the required
information.

The solution: RxTOOLKIT®
and BarTender® label software
DiTrapano first started using BarTenderin 2004. “Our hospital mandated newprocedures to ensure patient safety,
including a protocol for scanning druglabels and patient wristbands when a drug
was administered bedside,” he said. “Iwent looking for a pharmaceutical barcodelabeling system to help meet the mandate,but there was nothing commerciallyavailable at the time that filled our needs.”
While some pharmacy information systems
could generate labels, none could provide
the customization and interconnectivity
between systems that a regional healthfacility’s pharmacy required.
And none could generate Tall Man
text. “ISMP gives us guidelines and not
regulations, but we’re meticulous about
best practices. Patient safety is our primaryconcern, and not having Tall Man text is adeal breaker,” DiTrapano said.

The prompt screen is displayed once the pharmacist scans the barcode on the manufacturer label or selects the product brand name from a drop-down menu.

In addition to his role as a pharmacy
professional, DiTrapano is also presidentof HMMRx, whose mission is to improvemedication safety. To address the real-world
patient safety challenges that DiTrapano
was encountering, his HMMRx business
partner and CIO, John Neville, created anew pharmacy labeling safety management
solution, RxTOOLKIT.®
BarTender® label software from
Seagull Scientific is an integral part ofRxTOOLKIT’s labeling solution. In addition
to label design and printing, the system
uses VB Scripting in BarTender toautomatically calculate doses, capture
patient identification information, and tie
into national pharmaceutical databases foreach drug dispensed. The combined solution
is designed to meet the exacting dispensing
requirements of applications ranging from
NICU and pediatrics to the precise IV
infusion calculations and dosage tapering of
immunoglobulin therapy.
For products that need to be blended orreconstituted in the pharmacy, RxTOOLKIT
retrieves product information from national
databases to determine how much of eachactive ingredient, excipient or diluent needs
to be included, based on the drug andspecified dosage for the individual patient.

Labeling insulin pens
The hospital use of insulin pens wasparticularly suited to an RxTOOLKIT andBarTender solution.
Using the combined solution to createa dispensing label, the pharmacist caneither scan the code on the insulin pen’s
manufacturer label or type the word
“Insulin” into the provided field. In the latter
case, a drop-down menu of insulin brandnames appears. Once a product is selected,
the label displays in the formatting window.
The expiration information is automaticallyfilled in based on room temperature
expiration dates for the brand of insulin penchosen.

Comparison shopping,and BarTender wins again

The pharmacist then scans or types thepatient MRN or name. The template
automatically applies ISMP best practices,
including the use of all upper case lettersfor the patient, all lower case letters for thedispensing pharmacist, and two forms ofpatient ID.

A recent upgrade to the RxTOOLKIT operating

Once the label is printed, it’s affixed tothe pen via a new and innovative methodof attaching pharmacy labels, devised byDiTrapano specifically for insulin penapplications. Working with TSI Associates,
he devised the Clear Connect Label,™ asolutions. “I did consider all the other options,”

system required an updated version of the software
for installing label printer drivers. Curious about whatelse was on the market, Chuck DiTrapano thoroughly
evaluated the available barcode and labeling

DiTrapano said, “and even arranged a demo ofanother labeling product. Honestly, it fell short.
Nothing came close to what BarTender offers.”

JANE DOE
MRN: 4681352
EXP: 14 October, 2013

PRINT BY:john smith

LANTUS Insulin
U-100 (100 units/mL)
3 mL SoloStar Pen

JANE DOE

MRN: 4681352

Room Temperature

Room Temperature

The expiration information is
automatically filled in based onroom temperature expiration dates
for the brand of insulin pen chosen.

The label generated by RxTOOLKIT
includes expiration information and abarcode representing the patient name
and/or Medical RN for positive ID of penownership. Product information can beretrieved by scanning the product QR
code with a smartphone.

transparent adhesive sleeve that fastens
the patient label to the insulin pen as atag. All the patient, dosing and expiration
information required to safely dispense
and use the insulin pen can be displayed
without obscuring the manufacturer label
information.

The benefits
RxTOOLKIT is now deployed in hospital
pharmacies throughout the United States.
RxTOOLKIT insulin pen labels connect
key staff members across health caredisciplines, using barcodes generated
with BarTender labeling software to
make accurate, critical data immediately
and easily accessible. Nurses spend
less time looking for drug dosage andresource information, and more timecaring for their patients, while reliable
patient identification lessens the risk forpatient mix-ups. And because BarTender
automates crucial calculations, thepotential for error is reduced, which
results in improved confidence andefficiency among the clinical staff.
RxTOOLKIT and BarTender are integral
to communication, providing enhanced
patient safety, streamlined processes andreduced costs.

The label format and adhesive sleeve are designed to display all the information required to safely dispense and use
the insulin pen without obscuring the manufacturer label.

Synopsis
The labeling of insulin pens creates a unique setof issues for hospital pharmacists.
An insulin pen must be used by only the patient
it is prescribed for, to avoid cross-contaminationand infection.
P ens are easily mixed up from patient to patientin an inpatient setting.
Insulin pens are shipped from the manufacturer
and stored in the pharmacy under refrigeration.
 nce removed from refrigeration and dispensed,
Othere is a narrow window before the insulin
expires.
 ifferent brands of insulin have differentDwindows of expiration.

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Americas:
Sales@SeagullScientific.com+1 425 641 1408

www.SeagullScientific.com

T he manufacturer label and the dispensing label
must be visible on an insulin pen, which is small
in diameter and offers limited space to affix
labeling information.

EMEA:
EMEASales@SeagullScientific.com+34 91 198 4600

 est safety practices for pharmacy labelingBrequire a label to include special font formats,two forms of patient identification, proper
storage condition information, proper drug ID
information; and proper expiration date.
Traditional commercially available labelingsystems are expensive, and make it difficult for a
pharmacy to meet best safety practices.
RxTOOLKIT was developed using BarTendersoftware to automate the pharmacy labelingprocess and improve patient safety.
RxTOOLKIT’s BarTender-driven insulin penlabeling solution is easy to use, automaticallycalculates expiration dates, includes two forms ofpatient identification, and ties into national drugdatabases that the patient can access via QR
code and smartphone.

APAC:
AsiaSales@SeagullScientific.com+886 70 1018 4700

Japan:
JapanSales@SeagullScientific.com+81 3 4589 5400

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