Key Points
- 2,114 diabetic patients at the William Beaumont Army Medical Center in El Paso may have been exposed a blood-borne disease
as a result of incorrect procedures used during insulin administration.
- Up to 15 patients at a second facility may be at similar risk for similar reason.
- FDA issued a Healthcare Professional Sheet and an FDA news release on March 19 alerting healthcare professionals and patients
to the dangers involved in the sharing of insulin pens, cartridges, and needles.
Insulin pens are pen-shaped injector devices designed for patient self-administration of insulin. The pens are intended for
use by a single patient only. The pens have a reservoir or cartridge that can deliver multiple doses of insulin; however,
a new needle must be used with each injection. Patients should never share insulin pens, cartridges, or needles. If the insulin
pens, cartridges, or needles are shared, there is a risk of transmission of blood-borne pathogens, such as hepatitis B (HBV),
hepatitis C (HCV), and human immunodeficiency virus (HIV).
The FDA has received information that insulin pens may have been shared among many patients in one hospital and among a smaller
number of patients in another hospital.
A press release from the William Beaumont Army Medical Center, El Paso, Texas, announced that 2,114 diabetic patients admitted
to the medical center between August 2007 and January 2009 may be at risk for developing a blood-borne disease as a result
of incorrect procedures employed during the administration of insulin through insulin pens.
In August 2007, the medical center staff began using the insulin pens to administer doses of insulin to patients. In this
incident, although new sterile needles were used on all patients with each injection, the same pen may have been used on more
than one patient. The medical center staff planned to contact all 2,114 diabetic patients and offer screening for blood-borne
diseases such as HBV, HCV, and HIV. The investigation also revealed that the insulin pen may not have been used properly at a second facility and up to 15 patients
may be at risk for developing a blood-borne disease. Some of the patients who may have been exposed have reportedly tested
positive for hepatitis C. However, additional testing is needed to determine whether the hepatitis infection occurred through
the sharing of insulin pens, or whether those who tested positive had cases of previously undiagnosed hepatitis C.
Following receipt of this information, the FDA issued a Healthcare Professional Sheet and an FDA News Release on March 19,
2009, to alert healthcare professionals and patients that insulin pens and cartridges should never be shared between patients.
As stated above, the sharing of insulin pens, cartridges, or needles will result in risk of transmission of HBV, HCV, HIV,
or other blood-borne pathogens.
We would like to take this opportunity to highlight the following important safety information that was communicated in the
aforementioned Healthcare Professional Sheet:
- Insulin pens containing multiple doses of insulin are meant for use by a single patient only; they are not to be shared between
patients.
- Identifying the insulin pen with the name of the patient and other patient identifiers provides a mechanism for verifying
that the correct pen is used on the correct patient and can help minimize medication errors. Ensure that the identifying patient
information does not obstruct the dosing window or other product information such as the product name and strength.
- Be aware that the likelihood of sharing insulin pens and cartridges increases when the pens are not marked with the patient
name or other identifiers.
- The disposable needle should be ejected from the insulin pen and properly discarded after each injection. A new needle should
be attached to the insulin pen before each new injection.
- The same risk of transmission of blood-borne pathogens may exist with shared use of any reusable injection device.
- Hospitals and other healthcare facilities should review their policies and educate their staff regarding safe use of insulin
pens.
Pharmacists play an important role in patient care. When counseling, pharmacists should instruct patients that insulin pens
are designed for use by a single patient and should never be shared with another patient. Each pen has a reservoir or cartridge
that contains enough insulin for a patient to self-administer several doses or injections. Patients should be reminded to
remove and properly dispose of the used needle after an injection. The pen cap should be placed on the pen device between
each use. Storing the pen without the used needle will help prevent air, blood, and/or skin material from migrating into the
insulin reservoir or cartridge from the needle. Instruct patients that although the insulin reservoir or cartridge contains
anti-microbial agents, these agents are effective only against bacteria and are not effective against viruses, such as HBV,
HCV, and HIV.
Although these recent incidents occurred at hospitals, the risk of transmission of blood-borne diseases can occur in any setting,
such as long-term-care facilities, outpatient clinics, and even the home, if family members do not follow safe injection
practices.
If you become aware of medication errors or other adverse events involving insulin pens, please report them to the FDA's MedWatch
program available online at http://www.fda.gov/medwatch/.
Scott Dallas, RPh, USPHS, is Safety Evaluator, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology,
FDA. Carol Holquist,RPh, USPHS, is Director, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, FDA.
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