Medication Safety: An Important APSF Initiative Revisited

Author: Tricia Meyer, PharmD

Medication errors have been estimated to occur in approximately 5% of medication administrations during surgery with a large majority of them being preventable.¹ High-quality evidence-based literature on preventative measures is limited.

Medication utilization in the perioperative area is fundamentally different from the typical hospital patient care units. The anesthesia professional is the only practitioner involved with the total medication process of prescribing, preparing, dispensing, and administering the medications without the advantage of an extra check of other health care professionals such as pharmacists or nurses. Additionally, many of the drugs used in anesthesia are high-risk drugs with a narrow therapeutic index which contributes to the potential for a harmful medication error to occur.

In a recent review article entitled, “Medication safety in the operating room: literature and expert-based recommendations,” Wahr and colleagues undertook a rigorous literature review of publications and guidelines on medication errors/medication safety in the operating room to identify strategies to improve medication safety. This study is an update of a 2004 systematic review by Jensen that also identified evidence-based strategies for preventing drug administration errors during anesthesia.¹

Medication errors in the operating room are not uncommon and most are considered preventable. Interestingly, the researchers found in their review similar medication error rates or near miss rates across the globe, indicating a shared problem and concern of the profession.¹ New Zealand identified an error or near miss rate of 1:133 anesthetics; South Africa 1:274 anesthetics; Japan 1:450 anesthetics. The errors occurring most frequently were miscalculations of dose, concentration, or infusion rates; syringe or vial swaps; additional or missed dose(s). In the studies evaluated, the harm from these errors was found to be low; however, the authors did review a worrisome number of case studies that reported potentially lethal or lethal errors. These included wrong route, dilution or concentration errors, pump programming errors, allergic reaction of a known allergic drug, and failure to flush lines after drug administration. More concerning is a recent study, published in 2016, that found a higher rate of errors of 1 error in every 2.2 surgeries.²

The authors, who included human factors engineers, physician anaesthetists, and one pharmacist, searched peer-reviewed articles published over a 20-year span between 1/1/1994 and 1/1/2014. The inclusion criteria encompassed articles that contained recommendations on medication safety or that cited contributing factors for errors. Further searches were conducted for guidelines or consensus statements from the National Guidelines Clearinghouse and from reviewed publications describing guidelines or statements on medication safety recommendations.

Recommendations were rated corresponding to the type of publication. A point scale was modified by the human factors engineers from the Jensen article and was used to grade the recommendation findings.

After an extensive review of the publications, the researchers found 74 articles to include in the development of the guidelines in addition to 6 guidelines or sets of recommendations specifically addressing medication safety in the operating room. The researchers noted that there was a shortage of high-quality, randomized, controlled studies to guide intraoperative medication safety tactics and the authors depended on expert opinions. The guideline/recommendation sets that were used in the review were

1. Association of perioperative Registered Nurses (AORN)—2006
   2. Anesthesia Patient Safety Foundation (APSF)—2010
   3. American Society of Health-Systems Pharmacists (ASHP)—1999**
   4. Center for Disease Control (CDC)—2007
   5. Institute for Healthcare Improvement (IHI)—2013
   6. Institute for Safe Medication Practices, Canada (ISMP)—2008
   —————–
   ** Currently under final revision for updated recommendations**

The total number of recommendations collected from the review was 138. The recommendations were further refined to 44 and, from this point, a modified Delphi process was used to exclude elements that were determined not to be important to safety or items that could not be measured. The resulting number of recommendations after the process was 35 and the authors felt this list was more inclusive than previous recommendations based on an approach to include strategies to prevent common and uncommon errors.

Although the list of recommendations was primarily developed from expert opinion from either a review of a voluntary reported errors, solicited expert opinions, or formal consensus statement/guidelines, the authors carefully used a defined search strategy with inclusion and exclusion criteria, a systematic review process, a focus group review, and a mechanism for scoring the recommendations.

Many strategies proposed on medication safety have not been tested in randomized clinical trials. The number and variety of errors reported with contributing events and the cost of randomized controlled studies make it challenging if not virtually impossible to research each specific recommendation. Wahr et al. presented the recommendations with the most solid support of experts in the field. The items on the medication safety strategies list suggest possible tactics to lower medication errors. The outline of recommendation themes are as follows:

Patient Information
Drug Information
Cart Inventory
Administration
Pharmacy
Culture

The reader can access the complete list of the recommended medication safety strategies by accessing the publication. The authors emphasize that the lack of well-designed, randomized, controlled trials should not be used as an excuse to do nothing or to be misled into thinking the present status is acceptable. They also would like operative/anesthesia services to use the list of recommendations as a tool or checklist to analyze their capacity for errors and then develop improvements.

References:

1. Wahr JA, Abernathy III, JH, Lazarra EH, Keebler JR, Wall MH, Lynch I, et al. Medication safety in the operating room: literature and expert-based recommendations. Brit J Anaesth2017;118:32–43.
2. Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of perioperative medication errors and adverse drug events. Anesthesiology2016;124:25–34.