Medication Mishap Mitigation Drives 2008 APSF Workshop

“Innovations in Medication Safety in the OR” was the subject for the annual APSF Board of Directors’ Workshop held October 17 in Orlando, prior to the ASA annual meeting. Over 100 attendees included APSF directors, academic anesthesiologists, regulators, and industry representatives from several companies offering products intended to enhance the safety of medication administration during anesthesia care.

As introduced by Robert K. Stoelting, MD, APSF president, the vision of the activity was to help achieve a “six-sigma” or vanishingly small medication error rate in the OR. The proposed means to achieve this were identification of current possible solutions to OR drug errors as well as promotion of the exploration and development of new medication safety processes for anesthesia professionals.

Kick-off of the meaty presentations was by the workshop organizer/moderator, Jeffrey B. Cooper, PhD, of the Massachusetts General Hospital and APSF executive vice president, who fittingly harkened back to the very beginning of the concept of anesthesia patient safety as presented in his landmark 1978 publication of the “critical incident study.” That study was the first systematic study of human error as a cause of untoward anesthesia outcomes. Its results showed “syringe swap” or the unintended administration of an incorrect drug as the third most common cause of anesthesia critical incidents in the OR at that time. Dr. Cooper noted that the problem not only persists today but has increased proportionately as the inciting factor in adverse anesthesia outcomes because other events such as unrecognized breathing circuit disconnections (# 1 most common in 1978) have been virtually eliminated by the behavior-technology paradigm of “safety monitoring” in anesthesia care.

First up, presenting the history of anesthesia medication errors and types of solutions, was Dr. Alan Merry, chair of Anaesthesia at the University of Auckland, New Zealand, former chair of the Patient Safety Committee of the World Federation of Societies of Anesthesiologists, and currently leader of the anaesthesia group in the “Safe Surgery Saves Lives” campaign of the World Health Organization. He cited a 1995 survey in which 89% of responding anesthesia professionals acknowledged having committed a drug error and further detailed an extensive review of about 200 publications mentioning medication mistakes in anesthesia. The best data in the literature are from 2 prospective facilitated incident reporting studies that largely agree with many previous reports and suggest a rate of 1 reported drug error in about every 140 anesthetics, which, by definition, is an underestimate since unrecognized errors are not reported.

Dr. Merry noted that anesthesia providers are unique in that they both prescribe and administer drugs and do so at least 500,000 times in an average career, all the while facing confusing look-alike medication ampules and vials and, more recently, complex infusion pumps that have contributed to drug administration errors. As far as consequences of errors, one respected 2005 study showed a rate of 4 deaths per 1000 errors. As is true often in medical care, there is very little tolerance for mistakes that cause patient harm, and Dr. Merry cited one practitioner in New Zealand who was convicted of manslaughter after a fatal drug error.

Addressing types of possible solutions intended to help prevent anesthesia drug errors, Dr. Merry noted the need to address the dramatically increasing complexity in the anesthesia workplace (up to 41 steps involved in giving 1 traditional IV dose in the OR), and he evoked James Reason’s classic “Swiss cheese model” of human error in medical care, which explains that the coincidental lining up of “holes” or faults in the care system allows errors to slip through. Thus, is modern technology the answer for prevention? Computerized order entry, information management systems, and bar coding of medications have been offered as components of a potential solution to medication mistakes in anesthesia care. Valid as those elements may be, it was noted that a systematic review of anesthesia drug errors yielded a simple, basic 5-point checklist of remedial recommendations:1. Read the labels. 2. Check the labels with a second person or a device before drawing up or giving a drug. 3. Labels must be legible. 4. Syringes must be labeled. 5. Workspaces should be formally organized, particularly to separate or even remove dangerous drugs (e.g., KCl).

Interestingly, the long-favored proposal about uniform color coding of drug labels was seen as equivocal in that it was little help in prospective studies. A variant involved color-coded syringe plungers (red for muscle relaxants, blue for narcotics, green for pressors, etc.) and that is under study. A confounding factor in all these considerations is the “cultural” fact that the average practitioner simply denies that he or she could make a drug error and sincerely believes that he or she is “better” than “others.”

Dr. Merry concluded by explaining one comprehensive system (of which he is an inventor and holder of a commercial interest) that is an automated anesthesia record and a drug administration tool with pre-filled syringes and a bar code reader that causes the computer to speak out loud the drug being given. In one prospective study of the system, errors among all anesthesia drug administrations were reduced from 0.54% to 0.32%.

Robert Caplan, MD, member of the APSF Executive Committee, from Seattle’s Virginia Mason Clinic, has been one of the organizers of the ASA Closed Claims Study since its inception, and he reviewed the available data and their implications. Noting that the closed claims database by definition involves significant patient injuries, he reviewed 80 claims. Forty-four percent were the wrong dose, and more than 9 out of 10 of these overall, and every one in pediatric patients, were overdoses. Drug substitution accounted for 30% of the claims, contraindicated drugs were 10%, and mistimed drugs, 8%. Eighty-seven percent of drug error claims were judged by the review process to have been preventable, and 84% represented less than appropriate care. Sixteen percent of these claims were associated with permanent brain damage. Drug error claims significantly exceeded the rate and amount of associated payment compared to the closed claims overall. The claims led to a focus on overdoses and drug substitutions. Invoking the Toyota model of “forcing functions,” Dr. Caplan suggested that anesthesia drug administration should involve a self-check by the practitioner at the start of the process of giving a medication and then successive checks as required functions that might involve computerized order entry, pharmacist review, and/or a second-person review.

Tricia A. Meyer, PharmD, member of the APSF Committee on Education and Training and director of the Department of Pharmacy and assistant professor of Anesthesiology, Texas A&M Health Science Center, addressed the idea of how pharmacists can help prevent anesthesia drug errors. As background, she cited a US Pharmacopeia study of perioperative drug therapy that showed a 2.3-7.4% error rate. Noting that the actual process of administering drugs is where the majority of errors occur, and that “look-alike, sound-alike” drugs are involved in up to 50% of errors, she offered ideas for improvement. Pre-filled syringes from a pharmacy avoid several sources of error in the OR. Better labeling of ampules and vials used by anesthesia practitioners in the OR is important, including warning labels such as those that now often appear on muscle relaxants noting that the medication causes ventilatory arrest, but also including an additional clearly printed adhesive name/concentration label on each drug that is peeled off and used to label the syringe as the drug is drawn up. She noted that local anesthetics are particularly complex and maximum allowable doses poorly understood (and thus these should be specifically incorporated into the preoperative “time out”). Likewise, preoperative antibiotics should be chosen in advance so they can be prepared in correct dosage by weight in the pharmacy, which is particularly relevant to preventing pediatric overdoses. “High-alert medications” such as insulin and heparin, for all patients, but especially small children, should never be drawn or mixed in the OR but should come pre-filled from the pharmacy. All infusions should be in specific unique “standard OR concentrations,” preferably pre-mixed by the pharmacy. Also, allergy to sulfite preservatives in drugs is more common than appreciated, occurring in up to 1/100 patients. Finally, better communication from pharmacists to practitioners was offered as a key component in reducing drug errors. Bulletin boards in workrooms or by OR pharmacies can broadcast alerts/advice and show photos of new medication containers; helpful notes and suggestions can be included in drug trays and kits.

Member of the APSF Board of Directors and vice president of The Joint Commission (TJC), the omnipresent health care accrediting agency, Robert Wise, MD, shared an accrediting standards perspective on medication safety in the OR. He noted that TJC considers the OR a high-risk environment and cited various fatalities from OR medication accidents. TJC made medication labeling on the OR sterile field a 2005 national patient safety goal. Overall, the accreditation requirements are intended to minimize the confusion that leads to drug errors. All medications must be clearly labeled with drug name and strength. All original containers from which drugs are drawn should remain in clear view until after the end of the procedure. Then everything involving medications must be discarded after the case—no reuse of anything in any manner on another patient (although this unsafe practice has been documented to persist to this day, usually based on the standard fallacious reasoning: “I’ve never had a problem”). Dr. Wise advocated for strategies that will overcome this practitioner resistance as well as the need for and placement of more OR pharmacists. Also, Dr. Wise specifically noted that TJC seeks practitioner input and that he welcomed observations and ideas.

Timothy Vanderveen, PharmD, also is a member of the APSF Board of Directors. He is vice president of a division of Cardinal Health, a corporation that markets products used in medication administration. He addressed commercial solutions to anesthesia medication errors. He cited numerous traditional medication labeling safety hazards and cited the alternative benefits of pharmacy-prepared syringes of anesthetic medications (preferably filled by robots) marked with distinctive (print layout and lettering, color coding by drug class, and bar coded) labels. Such labels can have a “peel-off” duplicate to go on a traditional paper anesthesia record. The pre-filled syringes can be dispensed by OR pharmacies or computerized automated cabinets (centralized or, preferably, one in each OR). Standardization is critical. The 15 different available preparations of heparin and the highly-publicized recent accidents with infants were cited as dramatic examples of the need for agreed-upon standard concentrations and infusions, which becomes especially important during transfers from the OR to PACU or an ICU. Citing the significant potential for medication errors associated with inexperienced practitioners attempting to use unfamiliar infusion pumps, he noted the expected benefit of “smart pumps” that recognize the codes for drug and concentration on the syringe inserted in a pump to reduce errors. He also commented that target-controlled infusion technology has not yet been approved in the US.

One home-grown proprietary system to help address potential anesthesia drug errors in the OR is in use at Boston’s Massachusetts General Hospital (MGH), and this system was presented by Wilton Levine, MD, clinical director of that Department of Anesthesia and Critical Care. Each equipped anesthetizing location has a computerized anesthesia information management system and also a small color printer that prints unique colored waterproof labels for medication syringes. A scanner reads the bar code on each ampule or vial of medication and prints a syringe label with another bar code that is read again (with visual and audio read-back) and recorded as the medication is administered from the syringe to the patient. Time savings is more than 50% per administration and practitioners there have been enthusiastic about the system. Plans are in place to install the system in every OR at MGH with future consideration for the same in all sedating locations as well.

The final speaker for the formal presentations was Jerry Cohen, MD, long-time safety/quality researcher from the University of Florida and chair of the ASA Section on Professional Standards. He addressed “cultural and practical barriers to medication safety in the OR.” Again the idea of complex pathways and the “Swiss cheese” model introduced the concept of the multifactorial causes of drug errors. Errors involve “look-alike/sound-alike drugs,” incorrect doses, incorrect injection sites (arterial or epidural), contamination of drugs, and administration of contraindicated drugs (e.g., allergy). The list of causes of drug errors was familiar, but the key emphasis was on the lack of standardization of all aspects of medication use causing “chaos and distraction.” Barriers to improvement include egos, lack of agreement on best practices, communication limitation into silos (anesthesia providers vs. surgeon vs. OR staff), communication failure during hand-offs, lack of protocols/too much individual discretion, rapidity of impact (anesthesia – seconds, internists – next month), and production pressures. Interestingly, Dr. Cohen highlighted how computerized medication order entry and computerized information systems can, in many circumstances, actually increase the risk of anesthesia drug error in the OR because OR conditions are so unusual. Accordingly, benefits from such systems will require intense anesthesia input and compatibility testing. Likewise, Dr. Cohen made a plea for OR-specific medication protocols and rules that are hammered out by users who actually have to live with and in the systems they create. This, he maintained, should help overcome resistance to adoption, particularly of the required standardization of the entire anesthesia medication process. Hand-offs and also the availability of critical medications during transports were cited as other key issues. Adoption of technology to administer and record medications will be an iterative process requiring engineers to learn a great deal about anesthesia care. An associated issue is the need for one common unified automated medication administration record for the entire institution, including the OR. Encouraging a blame-free environment for error reporting and analysis as well as focusing on the role of fatigue in medication errors will contribute to an honest global process engaging all involved—administrators, regulators, and clinicians—to “drive out fear” associated with drug errors and reform the drug administration process once and for all.

The second phase of the workshop consisted of break-out sessions into four small groups to help formulate specific strategies in different areas to improve anesthesia medication safety. The session asking the question: “What research still needs to be performed?” was led by David Gaba, MD, human factors expert from Stanford and member of the APSF Executive Committee. The group produced a long list of potential research projects and the top ones, in order of priority, were 1) (recognizing the difficulty and expense of organizing such studies) randomized controlled trials of the various proposed technologies and systems and their impact on actual patient outcome; 2) bench and simulation research into the details of the human factors involved in all phases of anesthetic medication administration in the OR—particularly because many of the proposed interventions being touted have never been rigorously tested for relevancy to what actually occurs in the process; 3) expansion of studies and consideration, using both simulation and real-life observation, to include fast-paced, life-critical situations in which multiple providers may be injecting multiple medications via various access routes; 4) a confidential independent reporting system to collect and analyze anesthesia drug error incidents; 5) investigation of the relationship between medication administration practices in the OR and nosocomial infections; and 6) long-term observational studies by knowledgeable observers (uninvolved anesthesia practitioners?) who can provide background data on actual practice, performance-shaping factors, and the associated vulnerabilities and constraints.

The group led by Lorri Lee, MD, closed claims safety researcher from the University of Washington and member of the APSF Executive Committee, addressed the question: “What can industry do to make a difference?” The resounding loud answer started with “standardization.” Considering how this standardization would be achieved was a more complex matter. The group generated an alphabet-soup list of relevant professional and technical organizations with a challenge to industry to try to bring all these involved parties together to hammer out a cost-effective, technology friendly, standardized system that would supersede corporate competition and profit motive. Initial efforts could focus on standardized containers, peel-off labels for drugs drawn up in the OR, prefilled syringes, and a volume sensor on the IV line in addition to the associated bar code reader so the computerized information system would know the exact dose administered and could react in real time (clamp the IV tubing?) to medication errors as they are happening.

“What are the current best medication safety practices?” was the question approached by the group led by Matt Weinger, MD, human factors and quality researcher from Vanderbilt University and secretary of the APSF. The group addressed many aspects, starting with communication. Discussion of medication plans, what medications will be needed, and the specific location of any high-risk drugs in the room should help reduce confusion and intention errors. Thorough communication during hand-offs is critical. Read-back of any requests for medication is essential. Packaging suggestions included eliminating multi-dose containers, glass ampules, latex stoppers, and sulfite preservatives. Also, the familiar labeling standardization suggestions were repeated with the addition of the idea that containers of different classes of medications should have different shapes and feel, adding touch to the senses involved in discriminating among drugs. Standardization of concentrations and infusions was considered essential and, likewise, standardization of the storage and dispensing facility in the OR. Standardization of administration should involve some type of double-check immediately before any medication is injected. This might involve people, processes, and/or technology. Documentation of drugs given should be “seamless” and all empty containers should be kept until the case is over in order to facilitate checking exactly what was given. Drug disposal after an anesthetic also should be “seamless.”

The final group, led by Dr. Caplan, outlined what the APSF should do as the next steps in this campaign for anesthesia medication safety. An initial step would be to educate regulators about the unique issues of anesthesia drug administration so that they could shape more relevant regulations. Also, the APSF is in a unique position both to lobby for and to fund research into cultural, behavioral, and human factor issues that have chronically contributed to OR medication errors. A key APSF feature should be assisting in the development of educational programs that start at the beginning of medical or nursing school to instill in students specific medication safety behaviors as a foundation that would then be expanded during anesthesia training and later even more in continuing education programs for practicing clinicians. It was suggested that the APSF support universal installation of OR pharmacies, including a unique partnership between pharmacists and anesthesia professionals at the actual site and moment of medication delivery (which would also be executed under a standardized uniform protocol within each institution, which the APSF can help promote via encouraging national standards). The APSF should support and promote technologies and systems that address the complexities of the anesthetizing location and reduce error potential through standardization and reduction of complexity. Finally, the APSF has the means and motivation to promote practitioners and investigators to be leaders and innovators in anesthesia medication safety.

The summation of the day’s efforts was presented by Drs. Stoelting and Cooper. Many of the concepts had been highlighted by the “APSF action” group. Emphasis again was placed on the reality that the OR is unique and poorly understood as far as workflow dynamics, complexity, and human factors. Standardization seems to be the first remedial strategy cited by essentially everyone addressing the problem of anesthesia medication errors in the OR. This and related messages were received and endorsed by TJC and also William Schecter, MD, the APSF director from the American College of Surgeons, who fully agreed, enthusiastically endorsing interdisciplinary involvement and cooperation. From a practical standpoint, the leaders continued, however logical the value of the “forcing function” of using all pre-filled syringes for anesthesia care in the OR, the cost is an institutional barrier likely to persist for now. Also, it is true that there is, to date, no clearly conclusive evidence that this strategy would significantly reduce anesthesia drug errors. Accordingly, the parting thought was that, if possible, the APSF should organize a comprehensive study to evaluate the efficacy of using exclusively pre-filled syringes and pre-mixed infusions in the OR as well as other related proposed strategies to reduce drug errors and enhance anesthesia medication safety.

Five-Point Checklist for Avoiding Medication Errors

1. Read the labels. 2. Check the labels with a second person or a device before drawing up or giving a drug. 3. Labels must be legible. 4. Syringes must be labeled . 5. Workspaces should be formally organized, particularly to separate or even remove dangerous drugs (e.g., KCl).

Dr. John Eichhorn, Professor of Anesthesiology at the University of Kentucky, founded the APSF Newsletter in 1985 and was editor until 2002. He remains on the Editorial Board and serves as a senior consultant to the APSF Executive Committee.