UF Pharmacy Research: ENFit^® Products and Medication Administration

Making Informed Decisions Around ENFit^® Products and Facility Conversion

If ENFit^® products are designed for enteral feeding, why discuss pharmacy? A subsequent cascading effect following the change of enteral devices to the ENFit^® design can affect the ability to use safe, accurate oral slip-tip pharmacy syringes.

A hospital can transition pharmacy to ENFit^®, but is it that easy and should it be done?

According to two research articles related to ENFit^® syringes in the pharmacy, accuracy and safety can be compromised in the smallest patient population. These two studies* are summarized below:

Study #1: Female Low Dose Tip Syringes and Dosing Accuracy for Paediatric Patients

Female low dose tip syringes-increased complexity of use may compromise dosing accuracy in paediatric patients

Objective: To compare dosing accuracy of the female design to legacy syringes.

Clinically acceptable dosing variance is +/-10% for low-risk medications. This may be unacceptable for high-risk medications, though.  While the design of the low-dose tip (LDT) syringe was intended to reduce the risk of dosing errors, there had been no peer-reviewed literature that explicitly evaluated the LDT feature or the use of its associated dispensing and administration adapters. Because of this lack of data, this study was designed to evaluate the legacy vs. the female LDT syringes and the frequency of dosing variance >10%.

Results: Significantly higher rates of unacceptable dosing variance with 0.5ml and 1ml LDT syringes, compared to legacy syringes.

Of 576 tests evaluated, there were (108) legacy syringes, (378) LDT syringes, and (90) standard female syringes.

Conclusion: This study raises clinical concerns of dosing inaccuracies with the LDT syringes, particularly with 0.5 and 1 ml syringes.

Premature neonates in the United States receive an average of 17 medications per NICU admission. This average list does not decipher oral vs IV, but nearly half of the top medications listed as common high-risk paediatric/neonatal medications only come in oral form. The smallest patients are at highest risk for dosing inaccuracies due to the small volume dosing that is most prevalent in this patient population. The overall dosing variance >10% in this study was three times higher with LDT syringes than with legacy syringes when evaluated across potential testing and administration conditions.

Although this study did not evaluate the impact of administration adapters, using a different adapter for dispensing than administration can result in significant dosing inaccuracy.  Discrepancies were identified in the FDA-approved IFU(s) vs. manufacturer’s recommendations that suggested dosing accuracy is compromised depending on instruction and/or product education. This study highlights the importance of reading the instructions for use (IFUs) on all manufacturer products in order to have a clear understanding of exactly how it was intended to be used.

It was also highlighted that LDT syringes with adapters complicate administration, which essentially doubles the steps, increases completion time, and creates opportunity for error.

Study #2: Dosing Inaccuracy with Enteral Use of ENFit^® Low-Dose Tip Syringes

Dosing inaccuracy with enteral use of ENFit ^® low-dose tip syringes: The risk beyond oral adapters

Objective: Compare the performance of ENFit^® LDT syringes when used for enteral medication administration to the syringe performance during oral administration conditions.

In the previous study, legacy syringes were compared with LDT syringes for dosing accuracy. This secondary analysis was designed to determine if there is a difference in dosing accuracy in the ISO 80369-3 intended use (enteral) vs. the oral application of ENFit^® LDT syringes.

Results: Using LDT syringes for the enteral route resulted in statistically significant higher rates of unacceptable dosing variance >10% when compared to oral application.

LDT syringes were designed because of low-dose accuracy issues. This study showed, though, that enteral and oral application with LDT syringes posed significant accuracy issues at a +/-10% dosing variance, despite the LDT design. 

Of 264 test conditions that were evaluated (enteral, n = 96; oral, n = 168), 210 evaluated ENFit^® LDT (enteral, n = 78; oral, n = 132). A total of 5 enteral and 7 oral conditions/combinations were evaluated.

Conclusion: This study raises additional clinical concerns specifically related to the enteral use of ENFit^® LDT syringes within commonly accepted dosing variance ranges. Enteral and oral application of LDT syringes yield unacceptably high rates of dosing variance for high-risk medications with narrow therapeutic index.

Provider awareness of potential unsafe medication administration is critical, as dosing fluctuations caused by unreliable delivery can result in unexplained patient response to therapy. It is critical that, as healthcare providers, you are well-informed on the impact that ENFit^® LDT syringes and adapters can have on accurate medication delivery. As stated in O’Mara et al studies, “As the healthcare community continues to implement device-related processes to prevent tubing misconnections, front-line clinicians must be involved and assured that new potential sources of error not present in traditional systems are not introduced.”

In this case, the implementation of ENFit^®, including LDT syringes, in the pharmacy can have a cascade effect that potentially puts your smallest patients at risk. Recognizing this impact is an important first step.

Pre-planning for the ENFit^® transition and the introduction of ENFit^® products is critical. It is possible to transition enteral feeding to ENFit^® without the pharmacy impact. For this safe, cost-effective alternative option that allows ENFit^® to be implemented without changing current products or practice in the pharmacy, please learn more about the Low Dose Dual Cap.

*Medela products were not used in either study.

References

1. O'Mara, K., Gattoline, S. J., & Campbell, C. T. Female low dose tip syringes-increased complexity of use may compromise dosing accuracy in paediatric patients. Journal of clinical pharmacy and therapeutics. 2019;44(3): 463–470. https://doi.org/10.1111/jcpt.12810
2. O'Mara, K. & Campbell, C. T. Dosing inaccuracy with enteral use of ENFit^® low-dose tip syringes: The risk beyond oral adapters. Journal of clinical pharmacy and therapeutics. 2019;00:1-5. https://doi.org/10.1111/jcpt.13079