Evidence

Sāfen Medical product development, clinical use and implementation are evidence-based.

Sāfen Clinical Evidence Summary: The Problem

Medication Errors: Prevalence and Impact

53.3% of IV medications have an error

91 study review found that 73% overall probability of making at least 1 error in IV therapy. Common medication groups associated with medical administration errors include nutrition and blood, gastrointestinal system, cardiovascular system, central nervous system, and antimicrobials.

Keers RN, Williams SD, Cooke J, Ashcroft DM. Prevalence and Nature of Medication Administration Errors in Health Care Settings: A Systematic Review of Direct Observational Evidence. Annals of Pharmacotherapy 2013;47(2):237-256.

58.3% of IV medication errors were associated with incomplete IV labeling or inaccurate IV labeling (see Table 3)

An overall error rate of 14% was identified during the administering, documenting, and prescribing of IV infusion medication in an adult ICU. The mean number of errors per infusion order was 3.0. Up to 21 separate errors might occur in association with a single dose of an IV medication, and incorrect IV labels made up 31.5% of all errors.

Summa-Sorgini, Claudia, et al. “Errors associated with IV infusions in critical care.” The Canadian Journal of Hospital Pharmacy. 65.1 (2012): 19.

Each additional IV increases the likelihood of a medical error leading to an ADE by 3%

For every added intravenous drug administered, the odds ratio for error increased by 1.03 in critical care settings.

Kane-Gill, Sandra L., et al. “Analysis of risk factors for adverse drug events in critically ill patients.” Critical Care Medicine 40.3 (2012): 823.

Over 5% of surgeries involved a medical error (ME), of which 70% were preventable.

The majority (24%) of the errors were related to medication labeling. 50% of the MEs led to an ADE and 50% were considered significant.

Karen C. Nanji, Amit Patel, Sofia Shaikh, Diane L. Seger, David W. Bates; Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology 2016; 124:25–34.

Despite efforts, medication administration errors remain prevalent and a substantial portion occur in hospitalized pediatric patients.

Although smart pumps offer numerous safety advantages, they are also prone to implementation and human factors problems, such as difficult user interfaces and complex programming requirements that create opportunities for serious errors.

MacDowell, P., Cabri, A., & Mackey, M. (2018). Medication administration errors. AHRQ Publication No. 18-0047-EF. Rockville, MD: Agency for Healthcare Research and Quality. 2021. https://psnet.ahrq.gov/primer/medication-administration- errors

The Costs of Medication Errors — Financial

Medication errors harm an estimated 1.5 million people every year and average $600,000 in extra costs per hospital.

Preventable medication errors impact more than 7 million patients and cost almost $21 billion annually across all care settings. It is estimated that inpatient preventable ADEs associated with injectable medications increase the annual US payer costs by $2.7 billion to $5.1 billion.

Lahue, Betsy J., et al. “National burden of preventable adverse drug events associated with inpatient injectable medications: healthcare and medical professional liability costs.” American Health & Drug Benefits 5.7 (2012): 1.

Sāfen Clinical Evidence Summary: The Problem

The Costs of Medication Errors — Emotional

Medication errors harm staff, too.

Medication errors undermine staff confidence and detract from sense of safety in workplace.

“Physicians and other providers may feel a variety of adverse emotions after medical error, including guilt, shame, anxiety, fear, and depression.”

Robertson, Jennifer J., and Brit Long. "Suffering in silence: medical error and its impact on health care providers." The Journal of emergency medicine 54.4 (2018): 402-409.

Sāfen Clinical Evidence Summary: The Solution

Sāfen Clinical Evidence Summary

#3 National Patient Safety Goal for the Hospital Program: Improve the safety of using medications. “The labeling of all medications, medication containers, and other solutions is a risk-reduction activity consistent with safe medication management.”

This practice addresses a recognized risk point in the administration of medications in perioperative and other procedural settings. Labels for medications and medication containers are also addressed at Standard MM.05.01.09.

"National Patient Safety Goals® Effective January 2023 for the Hospital Program" The Joint Commission 2023.

IV line reconciliation programs can cut IV medication errors by 54%.

O’Byrne, Noeleen, Elizabeth I. Kozub, and Willa Fields. “Reducing continuous intravenous medication errors in an intensive care unit.” Journal of Nursing Care Quality 31.1 (2016): 13-16.

Standardization of processes for high alert medications is a key defense for IV errors.

A summary of 57 studies found key “systemic defense” for IV errors is standardization of the use processes for high-alert medications.

Kuitunen, Sini, et al. “Systemic causes of in-hospital intravenous medication errors: a systematic review.” Journal of Patient Safety 17.8 (2021): e1660.

Key medication administration error prevention strategies include tracing of infusion lines to confirm their correct intended medications, and standardized labeling, especially of high-risk medications.

MacDowell, P., Cabri, A., & Mackey, M. (2018). Medication administration errors. AHRQ Publication No. 18-0047-EF. Rockville, MD: Agency for Healthcare Research and Quality. March 2021.

Line labels or organizers increase infusion identification accuracy and efficiency. However, this solution would require standardization in labeling practices.

Fazio, Sarina, et al. “An Inadvertent Bolus of Norepinephrine.” AORN Journal 115.3 (2022): 291-293.

Correctness and completeness of labeling for IV infusions was addressed through pre-printed IV line labels.

Summa-Sorgini, Claudia, et al. “Errors associated with IV infusions in critical care.” The Canadian Journal Of Hospital Pharmacy 65.1 (2012): 19.

71% of IV medication errors observed involved high-alert infusions, with the most common being heparin, insulin, opioids, and parenteral nutrition.

Wollitz, A., and M. Grissinger. “Aligning the lines: an analysis of IV line errors.” Pennsylvania Patient Safety Advisory 11.1 (2014): 1-7.

The GōTo tag reduced the time to medication delivery, and was a preferred method to identify the resuscitation line by critical care providers.

Wampler, David A., Elizabeth Dillard, and Larry Miller. “Expediency and Accuracy of Identifying the “Resuscitation Line” Using a Visual-Tactile Marker in a Critical Care Setting.” Circulation 142.Suppl_4 (2020): A287-A287.

Manufacturer efforts to embed the principles of clear visual identifiers and infusion organization into infusion system design are urgently needed.

This will further reduce the burden on clinicians to reconcile discrete infusion components (e.g., bag, pump, tubing) and use add-on components, like labels/ organizers, since components may be better associated to begin with (e.g., perceptual markers, physical proximity).

Pinkney, S., Fan, M., Chan, K., Koczmara, C., Colvin, C., Sasangohar, F., Masino, C., Easty, A., & Trbovich, P. (2014). Multiple Intravenous Infusions Phase 2b: Laboratory Study. Ont Health Technol Assess Ser, 14(5), 1-163. https://www.ncbi. nlm.nih.gov/pubmed/26316919

Evidence

Sāfen Clinical Evidence Summary: The Problem

Sāfen Clinical Evidence Summary: The Problem

Sāfen Clinical Evidence Summary: The Solution

Sāfen Clinical Evidence Summary

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