Updated: October 2020
An anesthesiologist administered a dose of intravenous fentanyl to Patient #1 at the end of a surgical procedure. There was leftover medication in the syringe that needed to be safely disposed of, or “wasted”; the anesthesiologist placed a medication label on the syringe and then placed it in his pocket. The anesthesiologist proceeded to his next case, and after Patient #2 was induced and stable, the anesthesiologist placed this fentanyl syringe in the pocket of the automated dispensing cabinet (ADC) and notified the resident of the need to waste the medication. The resident mistakenly removed the syringe to be wasted from the ADC pocket during the procedure and administered the medication to Patient #2. Upon identification of the error, both patients involved were notified and an incident report was filed. When reviewing the event, investigators also noted several incidental findings of unsecured propofol in several areas including on top of a medication cart and in the computed tomography (CT) scan room.
By Daniel D. Nguyen, PharmD, Thomas A. Harper, MPH, CPhT, FCSHP and Ryan Cello, PharmD
Background and Significance
Operating rooms (ORs) and perioperative settings are environments with medication-use processes that present unique challenges as compared with other hospital settings. Perioperative medication administration often bypasses standard medication safety checks, and the high-stress and dynamic nature of procedures contributes to an increased risk for medication errors.1 The perioperative setting is one of the only areas where a single provider is often responsible for ordering, dispensing, preparation, administration, disposal, and documentation of medications without the assistance or check by a second provider.1 Studies report medication error rates between 5 to 11 percent of all medication administrations, with up to one-third of these errors leading to observed patient harm.2,3 The most common errors include wrong dose errors, medication labeling errors, and errors of omission.1-4
The need to improve medication safety in the OR has received increasing attention, and many organizations have published consensus statements on medication-use in the perioperative setting including the American Society of Health-System Pharmacists (ASHP), the Anesthesia Patient Safety Foundation (APSF), and the Association of periOperative Registered Nurses (AORN).5-7 The Institute for Safe Medication Practices (ISMP) recently received a grant from the FDA to develop a Self-Assessment for Perioperative Settings to provide facilities with a way to examine their medication safety practices, and The Joint Commission (TJC) continues to include perioperative medication safety practices as part of its National Patient Safety Goals (NPSG) with the most recent 2020 update.7,8
Systems Changes and Quality Improvement Approach
The “waste”, or safe disposal, of medications is an integral step in the medication-use process in the perioperative setting. The submitted case highlights how a variety of factors and quality gaps may contribute to errors during this step. In our commentary we will focus on the following factors: 1) medication waste workflow, 2) medication labeling, and 3) controlled substance accountability.
Medication Waste Workflow
A common recommendation to help reduce the risk of medication errors is to utilize the “rights of medication administration”, with the classic five rights being: the right patient, the right drug, the right dose, the right route, and the right time.9 However, the medication-use process does not start or stop at the administration of the medication, and while following these rights is a key safety practice it is also important to consider the implications of unsystematic practice within the entire medication-use system. In recent years, many have advocated for several additions to the classic five rights, with some organizations suggesting up to nine total rights.10 These additional rights include an often overlooked step: the appropriate documentation and recording of medications administered or wasted.11
Lack of proper documentation can lead to several additional errors beyond the lack of documentation. For example, if an anesthesia provider administers a dose of a paralytic agent but fails to record this and then hands-off the care of the patient to another provider, that individual may administer additional doses of the medication when they believe they are giving the sole dose of the drug.1,11 This error may never be identified or may lead to misdiagnosis based on symptoms presenting from the unknown administration, which can result in deleterious outcomes for the patient. These same principles apply to the proper timing and documentation of medication waste. Lack of documentation and failure to follow appropriate procedure when it comes to wasting medications can not only place the patient at additional risk, as demonstrated in the presented case, but also places legal and regulatory liabilities on the organization and provider. Experts recommend the best practice for documentation of medication waste in the surgical setting is to either waste any leftover product immediately after administration or to fully document all waste at the end of the case.1 At the close of a case, all medications that were partially used during the procedure should be disposed of in a non-retrievable fashion (including multi-dose vials), any non-labeled medications should be discarded, and any non-used (and non-contaminated) products should be returned to a secure location.1 Failure to comply with these recommended practices can lead to inappropriate reallocation of medications that have already passed through the sterile field. Unlabeled or unattended products may also increase the risk of exposing the patient to incorrect medications or to expired/deteriorated medications that were prepared in a non-sterile environment.1 In addition, proper disposal of medications not only helps to close the loop on the medication-use process, but also limits the opportunity for diversion or use by providers attempting to conceal their illicit use of controlled substances.
Organizations should develop clear policies and procedures surrounding the process for wasting of medications utilized in the perioperative setting. These policies should address the security and storage of medications, as well as proper oversight of controlled substances. Organizations should ensure that staff are provided with proper education on wasting of medications. Pharmacy staff should be made available to answer questions and educate providers on appropriate medication handling. In the absence of a physically staffed perioperative pharmacy, the utilization of ADCs may help to enhance accountability of both non-controlled and controlled substances.5 Many ADCs provide the ability to electronically document medication waste, and their placement in ORs may help facilitate the medication waste workflow and reduce the risk involved with storing waste for future disposal.
Pharmacy may also play a major role by examining different strategies for dispensing medications that limit overall waste. The fiscal impact of drug wastage in anesthesia can be significant, and many of the strategies aimed at reducing waste may also act as additional safety measures.12,13 Utilizing standardized dosing based on age or weight bands, providing standardized concentrations that reduce the need for manipulations or dilutions to prepare, dispensing prefilled syringes and premixed solutions, and preparing patient specific doses prior to a procedure are all viable strategies to reduce overall waste.1
Errors involving the labeling of medications in the perioperative setting are the most commonly reported error type.1-4 TJC requires that all medications, both on and off the sterile field, should be labeled if not immediately administered.8 TJC also provides further guidance on the necessary components of these medication labels, and experts recommend the utilization of a standardized label format to improve legibility and reduce the need for interpretation. Common strategies to differentiate between products (i.e. look-alike sound-alike medications) include: tallman lettering, color-coded labels, standardized concentrations, barcode assisted labeling, and others.1,14
Manual labeling of syringes and medications can be a tedious process that itself is error prone.14 Several barcode-assisted syringe labeling systems are currently available on the market that can help ensure compliance with regulatory requirements while also employing the above-mentioned safety strategies.15 In our submitted case, the provider remembered to label the syringe but the label either did not contain pertinent information to help differentiate between patients or did not provide a visual cue for the physician to pause. Strategies like utilizing color coded systems may have limited benefit but do serve as an additional signal to prevent syringe swaps between different medication classes.3 Merry and colleagues demonstrated that a multimodal program that incorporated barcode scanning reduced the error rate on medication administration in the OR by 21%.3
APSF also encourages administrators to work with vendors to augment their medication-use process with electronic tools that can interface with the electronic medical record.6 Barcoding systems have been shown to greatly reduce error, and utilization of barcoded medication administration (BCMA) not only confirms the details of the medication but also has the added benefit of improving timing of documentation and access to clinical decision support tools. These tools are a vital part of the many risk-mitigation strategies utilized in other areas of the hospital, but are still missing from most operating rooms.
Controlled Substance Accountability
The goal of controlled substance drug diversion programs is to prevent diversion and ensure accountability of medication throughout the medication use process while not impinging on providers or negatively impacting patient care. All controlled substances require additional monitoring to ensure compliance with applicable state and federal laws, and a thorough system for reconciling use should be developed and monitored.
The above case highlights several gaps in controlled-substance procedures that could place patients and the organization at risk. To reduce the potential risk of diversion, any unused controlled substance that is not intact in the manufacturer packaging would ideally be returned immediately at the end of case to the pharmacy to be wasted by a pharmacist. This process would allow an independent party to verify the use of the product against the record, as well as provide the opportunity to perform qualitative testing to verify unadulterated drug.5 For organizations where this workflow is not feasible or preferred, processes must be developed that require disposal of controlled substances to be conducted and documented in the presence of a witness. If immediate waste of a controlled substance is not possible, processes should be developed to ensure fully accountable use of all medications utilized during the case. Solutions may vary but can include documenting waste via automated dispensing cabinets or directly in the EHR with a witness.
Many non-controlled drugs also have high abuse or diversion potential, and organizations may also seek to apply similar policies and procedures to monitor their use. In this particular case, propofol was deemed as an institution-specific controlled substance. Periodic random audits may help identify failures to comply with organizational policies, and collaboration with departmental leadership is essential to ensure correction of these deficiencies.
The lack of a standardized process for wasting of medications in the perioperative setting can lead to errors that place both the patient and organization at risk. Medication management in the perioperative setting is uniquely challenging, and while some aspects of the medication-use process are similar to other hospital settings, the absence of many common safety nets can introduce additional challenges. Challenges include but are not limited to16
- Decreased access to clinical decision support tools for prescribing
- Management of multiple transitions of care as the patient is transferred through clinical areas
- Open-stock or non-profiled medication cabinets
- Lack ready-to-use or patient-specific medication preparations that require multiple manipulations
- Absence of BCMA
In light of these challenges, it is especially important to carefully examine the strategies that are currently present and to work to develop additional safety measures that address all steps of the medication-use process in this high-risk setting. Safe medication use practices should incorporate available safety technologies such as medication labeling and barcoding systems, and establish clear medication oversight workflows that account for all steps in the medication-use process.
- Waste medications either immediately after administration or at the end of surgical cases
- Establish clear policies and procedures that address the safety and regulatory risks involved with wasting of medications by anesthesia providers
- Standardize medication labeling and storage to ensure proper selection and reduce errors during medication administration
- Leverage available technologies to provide clinical decision support tools and mitigate risks involved with medication-use in the perioperative setting
- Account for all controlled substances utilized within the perioperative setting
- Evaluate controlled substance use processes to identify gaps that could lead to potential diversion and devise strategies to either audit those processes or bridge the gap
Daniel D. Nguyen, PharmD
PGY2 Medication-Use Safety Resident
Department of Pharmacy
UC Davis Health
Thomas A. Harper, MPH, CPhT, FCSHP
UC Davis Police Department
Ryan Cello, PharmD
Pharmacy Supervisor, Automation and Technology
Department of Pharmacy
UC Davis Health
- Wahr JA, Abernathy JH 3rd, Lazarra EH, et al. Medication safety in the operating room: literature and expert-based recommendations. Br J Anaesth. 2017;118(1):32-43. doi:10.1093/bja/aew379
- Nanji KC, Patel A, Shaikh S, et al. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology. 2016;124(1):25-34. doi:10.1097/ALN.0000000000000904
- Merry AF, Webster CS, Hannam J, et al. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation. BMJ. 2011;343:d5543. doi:10.1136/bmj.d5543
- Litman RS. How to prevent medication errors in the operating room? Take away the human factor. Br J Anaesth. 2018;120(3):438-440. doi:10.1016/j.bja.2018.01.005
- American Society of Health-System Pharmacists. ASHP guidelines on surgery and anesthesiology pharmaceutical services. Am J Health-Syst Pharm1999; 56: 887–95
- Eichhorn JH. APSF hosts medication safety conference: consensus group defines challenges and opportunities for improved practice. APSF Newsletter2010; 25: 1–8
- Association of periOperative Registered Nurses. AORN guidance statement: safe medication practices in perioperative settings across the life span. AORN J. 2006;84(2):276-283. doi:10.1016/s0001-2092(06)60495-x
- National Patient Safety Goals Effective January 1, 2020: Hospital Accreditation Program. The Joint Commission, 2020. Available at: https://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2020/npsg_chapter_hap_jul2020.pdf (Accessed on June 24, 2020).
- The five rights: A destination without a map. ISMP Medication Safety Alert. January 25, 2007;12(2).
- Elliott M, Liu Y. The nine rights of medication administration: an overview. Br J Nurs. 2010;19(5):300-305. doi:10.12968/bjon.2010.19.5.47064
- Merry AF, Anderson BJ. Medication errors--new approaches to prevention. Paediatr Anaesth 2011; 21:743.
- Kaniyil S, Krishnadas A, Parathody AK, et al. Financial Implications of Intravenous Anesthetic Drug Wastage in Operation Room. Anesth Essays Res. 2017;11(2):304-308. doi:10.4103/0259-1162.186596
- Chaudhary K, Garg R, Bhalotra AR, et al. Anesthetic drug wastage in the operation room: A cause for concern. J Anaesthesiol Clin Pharmacol. 2012;28(1):56-61. doi:10.4103/0970-9185.92438
- Grigg EB, Roesler A. Anesthesia Medication Handling Needs a New Vision. Anesth Analg. 2018;126(1):346-350. doi: 10.1213/ANE.0000000000002521
- Jelacic S, Bowdle A, Nair BG, et al. A system for anesthesia drug administration using barcode technology: the Codonics Safe Label System and Smart Anesthesia Manager. Anesth Analg. 2015;121:410–421.
- Hicks RW, Wanzer L, Goeckner B. Perioperative pharmacology: a framework for perioperative medication safety. AORN J. 2011;93(1):136-145. doi:10.1016/j.aorn.2010.08.020