6/20/2019
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`Considering Insulin Pens for Routine Hospital Use? Consider This ... I Institute For Safe Medication Practices
`
`Featured Articles (/newsletters/featured-articles).
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`Considering Insulin Pens for Routine Hospital Use? Consider
`This ...
`May 8, 2008
`Problem: A variety of insulin pen injectors (collectively called "pens") are currently
`available in the US. Intended primarily to facilitate easy and accurate patient self(cid:173)
`administration of insulin, pens also can be found in many hospitals (30%, according to
`our recent survey comprising 1,369 respondents) to administer insulin to patients.
`Switching from insulin vials to pens is gaining popularity, as they offer several
`advantages over vials:
`
`• Each pen is already labeled by the manufacturer with the product name and
`strength (whereas unit-based preparation of insulin from vials runs the risk of
`unlabeled syringes)
`• Each pen will be individually labeled with the patient's name
`• The pen provides the patient's insulin in a form ready for administration
`• The pen lessens nursing time needed to prepare and administer insulin
`• Insulin pens reduce medication waste that can occur when dispensing full insulin
`vials for each patient.
`
`Despite these advantages, some hospitals that switched to insulin pens are
`reconsidering this decision while others have employed the technology successfully
`and safely. Although it is not our intention to discourage appropriate use of insulin
`pens in hospitals, below we describe common problems encountered with these
`devices in an effort to help those who plan to or are currently using insulin pens guard
`against failures that could be harmful to both patients and healthcare
`practitioners.
`
`Needlestick injuries. Nurses have accidentally stuck a finger with a contaminated
`needle during pen delivery of insulin. Sometimes nurses pinch a thin patient's skin
`together when administering a subcutaneous injection. A needlestick may occur if the
`nurse does not maintain a 90 degree angle during the injection, as the needle may
`travel through the patient's skin and into the nurse's finger, which is holding the
`pinched skin. Along with misalignment of the angle of injection, visualization of the
`injection site during pen delivery of insulin can be poor, which has been reported as a
`contributing factor with this type of needlestick. Some insulin pen needles are not
`available with a needle guard, which presents another potential source of needlestick
`https://www.ismp.org/resources/considering-insulin-pens-routine-hospital-use-consider
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`1/4
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`Sanofi Exhibit 2180.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Considering Insulin Pens for Routine Hospital Use? Consider This ... I Institute For Safe Medication Practices
`6/20/2019
`injury-this one after the injection has occurred. While a needle guard will not prevent a
`needlestick injury during the administration process, as when pinching the patient's
`skin together, it can prevent exposure to a contaminated needle after the injection.
`
`User technique errors. Nurses have reported seeing a "wet spot" on the skin after
`injection, which they thought was insulin. They were afraid that the patient had not
`received the full dose, particularly since they could not visualize the medication being
`delivered. In some cases, the "wet spots" left at the injection site turned out to be a
`very small amount of insulin residue left on the skin from priming the pen before
`injection. In other cases, the "wet spots" involved substantial amounts of insulin. The
`plungers/buttons of some pens are difficult to push down, making it easy to
`accidentally lift the needle out of the skin when delivering the insulin, thus leaving a
`"wet spot." Insulin can also leak out of the injection site if the needle is not left in for
`about 6 seconds after injecting the insulin-another source of a "wet spot."
`
`To cite another example of technique errors, nurses (and patients) may not tip and roll
`insulin suspension (e.g., NPH, insulin mixtures) pens for proper mixing before use.
`This can result in large clumps of aggregated insulin flowing from the pen during the
`first injection, followed by subtherapeutic doses in subsequent injections.
`
`Using pens like vials. The wide variety of pen designs makes it difficult for
`practitioners to become competent using all possible devices. When nurses are not
`sure how to use a pen or encounter problems when trying to use it, they sometimes
`solve the problem by withdrawing the insulin from the pen cartridge using a sterile
`needle and insulin syringe. In these cases, the pen cartridge is used as a multiple(cid:173)
`dose vial for a single patient. In other cases, pen cartridges are used as floor stock for
`multiple patients, using a new sterile needle and insulin syringe for each puncture into
`the cartridge's membrane. Removal of insulin from the cartridge is not recommended
`by manufacturers unless an emergency exists and the pen is malfunctioning. Large
`air pockets or bubbles left behind in the cartridge after aspirating some of the insulin
`with a needle can result in dosing errors or subcutaneous injection of air if the pen is
`used to deliver a subsequent dose.
`
`Using a pen for multiple patients. In a recent newsletter (March 27, 2008, Cross
`contamination with insulin pens), we described several cases of using an individual
`patient's insulin pen for another patient. Some nurses thought it was acceptable to put
`a new disposable needle on the pen that had been used for one patient, and use it to
`deliver a dose of insulin to another patient, much the same as a multiple-dose vial
`
`https://www.ismp.org/resources/considering-insulin-pens-routine-hospital-use-consider
`
`2/4
`
`Sanofi Exhibit 2180.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Considering Insulin Pens for Routine Hospital Use? Consider This ... I Institute For Safe Medication Practices
`6/20/2019
`might be used for different patients. At least two studies have shown that biological
`contamination of insulin occurred in up to half of all insulin pen cartridges that had
`been used. It appears that air bubbles and pathogenic contaminants can enter the
`cartridge after injection while the needle is attached to the pen.
`
`Dispensing and administration errors. Although mix-ups among insulin pens may
`not be more common than mix-ups among insulin vials, pens and vials are subject to
`similar risks given the look-alike packaging of each manufacturer's line of insulin
`products and similarities in product names. For example, we have received numerous
`reports of dispensing mix-ups between the NOVOLOG MIX 70/30 (70% insulin aspart
`protamine suspension, 30% insulin aspart) FlexPen and the NOVOLOG (human
`insulin aspart) FlexPen. Similar mix-ups have happened to nurses and patients
`during drug administration. Administering a large dose of short-acting insulin,
`believing it is the long-acting insulin, can be fatal. (A new color differentiation system
`used by at least one manufacturer seems promising and will be the subject of a future
`report in this newsletter.)
`
`Pen design flaws. The design of some pens can predispose users to error. For
`example, the LANTUS (insulin glargine) OPTICLIK and APRIDRA (insulin glulisine)
`pens are available with a digital display of dose information that can be easily misread
`if the pen is held upside down, as a left-handed person might do. For instance, a dose
`of 52 units looks like 25 units, and a dose of 12 units looks like 21 units, when the pen
`is oriented incorrectly. (A similar misreading of digital displays [165 read as 591] also
`has happened with a glucose meter when the device was held upside down.1)
`
`Safe Practice Recommendations
`
`Potential problems with insulin pens are not insurmountable; the key to using these
`devices safely involves anticipating and reducing potential risks before
`implementation, and close monitoring during the first few months of implementation
`when unanticipated failures and workarounds are most likely to occur.
`
`FMEA. Practitioners, including prescribers, pharmacists, nurses, and diabetes
`educators, should conduct a failure mode and effects analysis (FMEA) and implement
`identified risk reduction strategies to prevent critical failures before using any insulin
`pen in the hospital.
`
`Formulary control. If possible, limit the variety of pens in the institution to promote
`staff education and ongoing competency with the devices.
`
`https://www.ismp.org/resources/considering-insulin-pens-routine-hospital-use-consider
`
`3/4
`
`Sanofi Exhibit 2180.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`Considering Insulin Pens for Routine Hospital Use? Consider This ... I Institute For Safe Medication Practices
`6/20/2019
`Education. Education before using pen devices is crucial for all users, but so is
`ongoing support when problems are encountered. Instructional videos are available
`online for many of the insulin pens and should be readily available to pharmacists and
`nurses from the organization's Intranet. Staff should be given clear instructions about
`how to proceed if they encounter problems, with real-time help accessible at all times.
`One hospital pharmacist recently told us that after the initial phase of education, one(cid:173)
`on-one trouble-shooting when problems were encountered was the key to successful
`implementation of insulin pens.
`
`Guidelines. Written guidelines should be developed for each type of pen available in
`the hospital. The guidelines should be comprehensive and include very specific
`information about safety, including how to handle pens for patients in isolation,
`prohibitions regarding sharing pens or using them as multiple-dose vials, how to apply
`pharmacy labels to pens without obscuring important information, and other relevant
`safety guidelines. Technical information about how to give the injection should be
`provided, including needlestick precautions, keeping the needle under the skin for
`about 6 seconds after injection, and removing the needle immediately after injection
`to prevent entry of air or contaminants into the cartridge. Patient education materials
`should also be provided.
`
`Although certainly not the only motivation for ensuring safe practices when using
`pens, compliance with The Joint Commission (T JC) standards should be considered.
`While T JC does not require organizations to use pens, facilities that use them may be
`cited for failing to comply with Infection Control standards (IC 3.10, EP.2) if pens are
`reused for multiple patients, and with Human Resources standards, for failing to
`validate staff competency with pens. As we mentioned in our November 30, 2006,
`newsletter article, PEN injectors: Technology is not without imPENding risks, we will
`continue to work to establish safe practice guidelines that can be employed in both
`the hospital and home setting to maximize safety when using pen technology to
`deliver medications.
`
`Reference
`
`1. Steward D et al. An avoidable cause of false home glucose measurement.
`Diabetes Care. 2001 ;24:794.
`
`https://www.ismp.org/resources/considering-insulin-pens-routine-hospital-use-consider
`
`4/4
`
`Sanofi Exhibit 2180.004
`Mylan v. Sanofi
`IPR2018-01676
`
`