Patient Safety Tip of the Week
March 10, 2015
FDA Warning Label on Insulin Pens:
Is It Enough?
Despite several
warnings from ISMP, the FDA, and CDC a series of incidents involving insulin
pens being used on multiple patients, potentially causing cross-contamination
of patients with blood-borne pathogens, have received considerable attention over
the past several years. We discussed them in considerable detail in our February 26, 2013 Patient Safety Tip of the
Week “Insulin
Pen Re-Use Incidents: How Do You Monitor Alerts?” and our What’s New in the
Patient Safety World columns for April 2013 “More
Tips on Insulin Pen Safety” and April 2014 “Insulin
Pens - Again”.
The FDA has just
issued a safety announcement regarding required labeling changes to insulin
pens (FDA
2015). The new requirement actually
extends to multiple medications for diabetes that are administered by pens or
similar devices. The new
requirement is that pens and packaging containing multiple doses of insulin and
other injectable diabetes medicines display a warning label stating “For
single patient use only.”
While that action is
an important one and one that should have been implemented long ago, is that
enough? We hardly think so. Unless there are interventions that are forcing
functions or constraints we are likely to see continued occurrence of these
potentially serious incidents.
In our What’s New in the Patient Safety World column for April 2014
“Insulin
Pens - Again”) we noted that ISMP had strongly questioned whether hospitals
should remove insulin pens from inpatient use all together (ISMP
2013a), a position we would support.
Then in October 2014 ISMP did an eye-opening report where a
multihospital system had instituted a series of well-thought-out interventions
to help avoid insulin pen errors and monitored their results (ISMP
2014). These best practices included extensive staff education, use of a
standardized insulin type (rapid-acting), tape applied to the pen to indicate
when it has been used, order-specific barcoding labels and barcode system
alerts, reminders and help on eMAR and order entry
screens, and a comprehensive monitoring system. They note that overall barcode
scanning of the patient, pen, or both occurred in over 99% of insulin doses.
But since almost 80,000 insulin doses were given, that meant that mistakes in
up to 800 patients could still occur. The rate of near misses averted by
barcode scanning was less than 1% but again, given the high number of insulin
doses, this amounts to a substantial number of cases that might be occurring in
facilities not doing this sort of bar code scanning.
Despite these best practices, insulin pen errors continued
to occur. In the 3 months after implementation of these best practices in that
multihospital system 7 patients still received an insulin dose using another
patient’s pen. Analysis of those cases did not show a knowledge deficit as
being contributory. Rather, system errors contributed to the occurrences. For
example, using pens from other patients that had not been removed from
automated dispensing cabinets or locked patient storage drawers was a factor.
Similarly, nurses carrying more than one pen (destined for more than one
patient) was a risk factor. You may recall that we recommend you never try to
carry medications or equipment for multiple patients at the same time. In our June
19, 2007 Patient Safety Tip of the Week “Unintended
Consequences of Technological Solutions” we described an instance where a
nurse carrying remote telemetry transmitters for two patients transposed them,
resulting in failure to promptly attend to a patient in ventricular fibrillation.
And our April 23, 2007 Patient Safety Tip of the Week “Predictable
Errors” gave several other examples where the wrong item is chosen when you
are carrying “two of something” with you.
Citing this “crack in our best armor” ISMP stopped just
short of calling for an “all-out moratorium on using insulin pens in hospitals”
but noted it leans toward using them only in special circumstances, such as
those that may become available with more concentrated insulin preparations.
Remember, just going back to using insulin vials is also not
without some risks. These include concentration issues, look-alike vials, and
many other issues. We discussed many of
these issues in our November 2, 2010 Patient Safety Tip of the Week “Insulin:
Truly a High-Risk Medication” and our July 2014 What’s New in the Patient Safety World
column “Joint
Commission Sentinel Event Alert: Don’t Misuse Vials”. ISMP also had an
excellent prior column on hazards associated with use of insulin vials (ISMP
2013b).
We hope you’ll read
through our recommendations in our prior columns on the insulin pen issue
(listed below) and the cited ISMP alerts. This is clearly a system issue and
requires system fixes. Just attaching a warning to the labels and educating
your staff and patients is not going to make this problem go away.
Some of our prior
columns highlighting the safety issues of insulin pens and similar devices:
November 2, 2010 “Insulin:
Truly a High-Risk Medication”
February 26, 2013 “Insulin
Pen Re-Use Incidents: How Do You Monitor Alerts?”
April 2013 “More
Tips on Insulin Pen Safety”
April 2014 “Insulin
Pens - Again”
July 2014 “Joint
Commission Sentinel Event Alert: Don’t Misuse Vials”
References:
FDA. FDA Drug Safety Communication: FDA requires label
warnings to prohibit sharing of multi-dose diabetes pen devices among patients.
FDA Safety Announcement 2015; February 25, 2015
http://www.fda.gov/Drugs/DrugSafety/ucm435271.htm
ISMP (Institute for Safe Medication Practices). Ongoing concern
about insulin pen reuse shows hospitals need to consider transitioning away
from them. ISMP Medication Safety Alert! Acute Care Edition. February 7, 2013
http://www.ismp.org/Newsletters/acutecare/showarticle.asp?id=41
ISMP (Institute for Safe Medication Practices). A crack in
our best armor: “Wrong patient” insulin pen injections alarmingly frequent even
with barcode scanning. ISMP Medication Safety Alert! Acute Care Edition 2014; October
23, 2014
http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=92
ISMP (Institute for Safe Medication Practices). A clinical
reminder about the safe use of insulin vials. ISMP Medication Safety Alert! Acute Care Edition 2013; 18(4): 1-4
February 21, 2013
http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=42
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