|As a follow-up to the 2018 Medication Safety Stoelting Conference, the APSF held a panel session titled “Practical Approaches to Improving Medication Safety” at the 2019 ASA Annual Meeting, in Orlando, FL. The goal of the APSF-sponsored safety panel was to provide front-line clinicians with actionable strategies to reduce medication errors.|
Medication Safety Issues from a Manufacturer’s Perspective
by John W. Beard, MD, MBA
Dr. Beard presented a view of medication safety through the lens of manufacturing safety and the anesthesia medication workflow. He identified key FDA safety principles, including the manufacturer’s obligation to introduce products to market only after establishing that they are safe and effective for the intended use. He emphasized the importance of human factors engineering in medical device design and product testing. By citing recommendations from the European Union Medical Device Regulation, he stressed that risk is preferably eliminated through design, and when residual risk exists it should be mitigated through additional methods such as protective equipment, alarms, labeling, and training.1
Computerized physician order entry, double-checked medication dispensing and preparation, and bar code medication administration at the time of administration for pills and injections may add a higher level of safety to medication administration practices. Adoption of smart pump-electronic health record (EHR) interoperability technology may also provide an improvement in medication safety. The interface between smart pumps and EHR works as a bidirectional wireless communication between the smart pump and EHR, which enables “auto-programming” of infusion parameters onto the pump and “auto-documentation” of infusion pump activity into the EHR. In non-OR environments, smart pump-EHR interoperability has been shown to reduce medication errors, increase efficiency, and increase the accuracy and completeness of documentation.2-4
Infusion pump medication errors in anesthesiology were also highlighted. Although published data is limited, a 2010 New Zealand study demonstrated that nearly one-third of self-reported medication errors were related to infusion pumps.5 In a 2018 University of Washington study, infusion pump errors were identified and significantly reduced by implementing a “smart pump bundle” which included implementing smart pumps for medication infusions, standardizing infusion concentrations, and using centralized pharmacy preparation of infusion medications.6
Dr. Beard recommended that anesthesia professionals take the following actions to improve infusion safety in the perioperative environment:
Table 1 : Author’s Suggestions To Improve Medication Infusion Safety
|Utilize smart pumps for the delivery of medications and fluids*|
|Standardize smart pumps in operating rooms and nonprocedural locations|
|Standardize concentrations of continuous medication infusions for use in anesthesia and across units|
|Utilize centralized pharmacy preparation of continuous drips|
|Analyze smart pump data to evaluate clinician compliance and smart pump effectiveness|
*This recommendation is consistent with draft ISMP smart pump guidelines, which indicate that fluids are preferentially administered by smart infusion pump although gravity administration continues to have application in select circumstances.7
Dr. Beard is medical director and shareholder of ICU Medical, Chicago, IL, and a member of the APSF Editorial Board.
Drug Administration Errors: Simple Steps to Improve the Anesthesia Workspace and Reduce the Risk of Medical Errors
by Dr. Eliot Grigg, MD
Dr. Grigg highlighted the importance of streamlining processes and simplifying options for medication handling in the OR.8 Many forms of safety countermeasures—like labels, alarms, and two-provider checklists—provide feedback instead of more robust constraints. Prefilled syringes, for example, eliminate 6 sub-steps (prescribe, prepare, dispense, administer, record, and monitor) and 19 possible failure modes from medication preparation versus bar-coding, which does not provide a physical countermeasure but does require user compliance.9 Ultimately, the goal of medication safety design is to eliminate unnecessary options (like excessive concentrations), automate processes (like wireless programming smart pumps), and physically prevent mistakes (like new Luer connectors for regional anesthesia).10
Dr. Grigg is associate professor of Anesthesiology at University of Washington and has no financial disclosures.
Drug Shortages: Practical Substitutes When Your Most Important Anesthetic Medications are Missing
by Joyce A. Wahr, MD
Medication shortages have significantly impacted physicians in general and anesthesia professionals in particular, especially since the worst shortages involve sterile, generic medications. Shortages are inherently dangerous because providers must adapt to new and different appearances or formulations of standard medications, or become familiar with the dosing, side effects, and nuances of a substitute (e.g., glycopyrrolate for atropine).11 When tracking shortages, the FDA only counts a medication in short supply when there is no other substitute available. The American Society of Hospital Pharmacists (ASHP), however, considers whether a shortage causes pharmacies to change how they provide that medication. Since an acute change in the look, concentration, or expiration date of a medication poses real risks for medication errors, the ASHP list of medications in short supply is more extensive than the FDA’s shortage list.
The FDA has implemented a number of approaches to mitigate the impact of medica-tion shortages but has little power to eliminate them.12 Nearly 40% of injectables are produced by only one manufacturer, and any disruption in the supply chain or manufacturing may result in a shortage. Natural disasters, such as Hurricane Maria, which significantly impacted IV fluid manufacturing, can cause an abrupt reduction in the supply of medications. Consolidation of manufacturers, elimination of competition, changes in distributors—all make management of medication shortages extremely difficult.
Often hospital pharmacies have to reach outside normal distribution chains to maintain a normal supply of a critical drug. This process can lead to falsified or substandard medications, such as the substandard heparin that was responsible for at least 10 deaths in the US, or the chemotherapeutic agent that had no active ingredient.13 Medication shortages are expensive: most hospitals have a full-time pharmacist to manage shortages and shortages allow manufacturers to increase prices.14 Table 2 provides some clinical suggestions on how to approach drug shortages.
Table 2: Author’s Suggested Approach to Drug Shortages
|Every anesthesia group should form a medication shortage committee that is led by pharmacists and includes cardiologists and intensivists|
|The committee should meet on a biweekly or monthly schedule to review developing and resolving shortages|
|Strategies for mitigation should be prepared, including waste reduction, use reduction, supplier change, substitute identification, or formulation changes|
|The committee should communicate shortage details to clinicians, including the mitigation strategies|
|Providers must also be alert to the possibility of substandard or falsified medications that may appear in our medication cart|
Dr. Wahr is a professor and vice chair of Quality and Safety in the Department of Anesthesiology, University of Minnesota. Dr. Wahr speaks on behalf of medication safety for Aspen Medical.
Standardization of Drug Labeling and Concentrations: Are We Different Than Other Groups Who Administer Drugs?
by Elizabeth Rebello, Rph, MD, FASA, CPPS
Standardizing drug concentrations may mitigate medication errors. This process should focus on developing the fewest number of drug concentrations to provide safe clinical care. Standardization may include a limited set of concentrations for medications that have been labeled as high-alert or are known to have produced a significant number of adverse events.
The ASA Committee on Quality Management and Departmental Administration (QMDA) convened a medication standardization safety workgroup to explore solutions regarding drug concentration standardization to safeguard patients with medication administration and to improve anesthesia professional workflow. An extensive literature review, closed claims studies, and the REMEDI database served as important sources of data for the workgroup.9,10,15-29 These efforts were highlighted in the 2018 Anesthesia Patient Safety Foundation (APSF) Stoelting Conference, “Perioperative Medication Safety27: Advancing Best Practices,” and the following 10 medications were identified with recommendations for drug concentration standardization:
In addition to the lack of concentration standardization, drug mislabeling can increase patient risk. The APSF has created a standardization and innovation workgroup and has sponsored three conferences addressing overall medication safety. The Food and Drug Administration has made provisions for locations where specific types of labeling, such as the use of color-coded labels based on class of medication in the operating room, have an established use.16 The variance of medication administration in and out of the perioperative environment due to incremental versus complete administration further confounds the issue. Anesthesia professionals have a unique understanding of the challenges and should consider being engaged both at the local and national level to provide input regarding this important patient safety issue.
Dr. Rebello is associate professor in the Department of Anesthesiology and Perioperative Medicine at the University of Texas MD Anderson Cancer Center and has no financial disclosures.
The APSF has identified multiple techniques to improve medication safety in the operating room that are readily implemented in today’s procedural environment. Anesthesia professionals can adopt best practice medication safety techniques, including consideration of those summarized by the APSF Medical Safety Panel, to maximize patient safety and work to ensure that “no one shall be harmed by anesthesia care.”
- European Union Medical Device Regulation. 5 April 2017.
- Ohashi K, Dalleur O, Dykes PC, et al. Benefits and risks of using smart pumps to reduce medication error rates: a systematic review. Drug Saf. 2014;37:1011–1120.
- Prusch AE, Suess TM, Paoletti RD, et al. Integrating technology to improve medication administration. Am J Health Syst Pharm. 2011;68:835–842.
- Suess TM, Beard JW, Trohimovich B. Impact of patient-controlled analgesia (PCA) smart pump-electronic health record (EHR) interoperability with auto-documentation on chart completion in a community hospital setting. Pain Ther. 2019;8:261–269.
- Webster CS, Larsson L, Frampton CM, et al. Clinical assessment of a new anaesthetic drug administration system: a prospective, controlled, longitudinal incident monitoring study. Anaesthesia. 2010;65:490–499.
- Bowdle, TA, Jelacic S, Nair B, et al. Facilitated self-reported anaesthetic medication errors before and after implementation of a safety bundle and barcode-based safety system. Br J Anaesth. 2018;121:1338–1345.
- 7. Optimizing Safe Implementation and Use of Smart Infusion Pumps. ISMP Post Summit Draft Safe Practice Statements. https://www.ismp.org/resources/draft-guidelines-
optimizing-safe-implementation-and-use-smart-infusion-pumps. Accessed December 2, 2019
- Grigg, E.B., Litman, R.S. Feedback and constraints: rethinking medication safety countermeasures. Br J Anaesth. ,2018;121:1188-90.
- Martin, LD, Grigg EB, Verma S, et al. Outcomes of a failure mode and effects analysis for medication errors in pediatric anesthesia. Pediatr Anesth. 2017;27:571-80.
- Grigg, EB, Roesler, A. Anesthesia medication handling needs a new vision. Anesth Analg. 2018;126:346–50.
- Fox ER, Sweet BV, Jensen V. Drug shortages: a complex health care crisis. Mayo Clin Proc 2014;89:361-7.
- Rinaldi F, de Denus S, Nguyen A, et al. Drug shortages: patients and health care providers are all drawing the short straw. Can J Cardiol. 2017;33:283-86.
- Labadie J. Forensic pharmacovigilance and substandard or counterfeit drugs. Int J Risk Saf Med. 2012;24:37-9.
- Hernandez I, Sampathkumar S, Good CB, et al. Changes in drug pricing after drug shortages in the United States. Ann Intern Med. 2019;170:74-76.
- American Society of Health-System Pharmacists. Proceedings of a summit on preventing patient harm and death from i.v. medication errors. July 14–15, 2008, Rockville, Maryland. Am J Health-Syst Pharm. 2008;65:2367–79.
- Bowdle TA. Drug administration errors from the asa closed claims project. ASA Newsletter. 2003;67:11–13.
- Cooper L, Barach, P. Sweeping it under the rug: why medication safety efforts have failed to improvement care and reduce patient harm. ASA Monitor. 2018;82:36–38.
- Eichhorn JH. APSF hosts medication safety conference: Consensus group defines challenges and opportunities for improved practice. APSF Newsletter. 2010;25:1–19.
- Institute for Safe Medication Practices (ISMP). List of High-Alert Medications in Acute Care Settings. https://www.ismp.org/recommendations/high-alert-medications-acute-list. Accessed August 16, 2018.
- Institute for Safe Medication Practices (ISMP). Survey results: smart pump data analytics pump metrics that should be monitored to improve safety. July 12, 2018. https://www.ismp.org/resources/survey-results-smart-pump-data-analytics-pump-metrics-should-be-monitored-improve-safety. Accessed July 27, 2018.
- Martin DE. Medication errors persist: summit addresses intravenous safety. APSF Newsletter. 2008;2:37,39.
- Merry AF, Anderson BJ: Medication errors—new approaches to prevention. Paediatr Anaesth. 2011;21:743–53.
- Nanji, KC, Patel A, Shaikh S, et al. Evaluation of perioperative medication errors and adverse drug events. Anesthesiology. 2016;124:25–34.
- Phillips, MS. Standardizing i.v. infusion concentrations: national survey results. Am J Health-Syst Pharm. 2011;68:2176–82.
- Sandnes DL, Stephens LS, Posner KL, Domino KB. Liability associated with medication errors in anesthesia: closed claims analysis. Anesthesiology. 2008;109:A770.
- Wahr, JA, Abernathy JH, Lazarra EH, et al. Medication safety in the operating room: literature and expert-based recommendations. Brit J Anaesth. 2017;118:32–43.
- https://www.apsf.org/past-apsf-consensus-conferences-and-recommendations/ Accessed October 10, 2019.
- Regenstrief National Center for Medical Device Informatics, Regenstrief Center for Healthcare Engineering, Purdue University, 2019. https://catalyzecare.org/remedi Accessed October 10, 2019.
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-container-labels-and-carton-labeling-design-minimize-medication-errors Accessed October 10, 2019.