Risk Update: Drug Shortage Safety Implications

With the shortage of lidocaine, many healthcare organizations are finding themselves in a position of mixing or reconstituting medications, previously provided as pre-mixed solutions by the manufacturer (i.e. local anesthetics with epinephrine). When dealing with supply shortages and the need to change practice and procedural process, it is important for organizations and providers to evaluate potential safety implications to mitigate risk associated with such challenges. It is imperative to develop standard practices that support the reduction of dispensing errors and minimize adverse events related to any medication shortages. Going back to the basics of safe medication administration and handling processes, as well as safe preparation of injections frequently utilized in practice, is an essential step. Not only can the mixing of two or more medications increase the risk for medication errors, mixing of medications specifically for injection use can contribute to injection-related site infections. To reduce occurrences of error, physicians and providers who prescribe and administer injections, should consult with their anesthesia providers and pharmaceutical colleagues to determine appropriate dosage, dilution concentrations, and develop standard protocols for safe handling and administration of local anesthetics that require mixing within the practice or outpatient environment. Only licensed providers (RN, PA/NP, MD) who have been formally trained should dose, mix and administer such medication as standard best practice to reduce risk potential.

The Basics

1) Safe medication administration: What began as the 5 “Rights” is now the 8 “Rights.”These steps are the hallmark of safe medication administration. The 8 “Rights” have historically been a nursing concept and not standard practice among all disciplines within the medical team or systemically built into process and procedures in medical practices and outpatient locations. Staff and providers involved in medication administration (including injections) should be proficiently trained to utilize the 8 “Rights” with eachpatient, every time. Gaps in utilization and lack of adherence to systemic processes and procedures to support medication safety may lead to medication errors and preventable adverse events.

8 “Rights” of Safe Medication Administration: Right Patient, Right Medication, Right Dose, Right Route, Right Time, Right Documentation, Right Reason, and Right Response

Right Dose, confirms the patient is receiving the intended dose. When it comes to provider-prepared medications, Right Dose must also include confirming the Right Concentration, as concentrations of medications can be tricky and easily misread, due look-alike situations and labeling. For example, Epinephrine vials, ampules, or injectors that are available in an ASC or procedural area could have concentrations of 1mg/mL (1:1,000), 0.1mg/mL (1:10,000) and 0.01mg/mL (1:100,000). Unintentionally utilizing a higher concentration instead of a lower dose, could lead to adverse patient outcomes, non-therapeutic dosing, or ultimately, even patient death. A recent event in Wisconsin involving an orthopaedic surgeon being sanctioned by their state medical board provides a learning case for medication safety, proper dosage/concentration and mixing of local anesthetics.

WI Surgeon Sanctioned in Patient Death

2) Safe injection practices: Injectable drugs, prepared in patient care areas for immediate use, are more likely to be contaminated than medications prepared in a compounding facility. Safety organizations and medical societies urge providers to utilize manufacturer or pharmacy prepared pre-filled medications to prevent infections/contaminants and errors in dosing/concentrations. However, when such is not available, healthcare organizations must ensure providers charged with mixing and administering injections are trained with the competencies and have the equipment necessary for safe injection practice. The CDC provides guidance, training, and checklists for safe injection practices.

Safe Injection Practices – How to Do It Right

Safe Injection Practices – Checklist for Outpatient Locations

Additional Risk Management Strategies to Enhance Medication Safety:

1) Use of Caregiver-Initiated Protocols: Consider posting protocols for the procedural use and lidocaine/epinephrine dilution in areas of close physical proximity to the medication preparation area. These protocols can guide licensed personnel responsible for withdrawing/reconstituting/mixing medications to utilize the appropriate doses/concentrations and assist in medication safety.

2) Visual Safety Alerts: Use color-coded labeling or stickers (applied during drawer restock and independently checked by two staff members) to serve as a visual cue for providers/personnel to differentiate hi-dose/low-dose concentrations of epi and/or separated in different retrieval bins for initial drug retrieval. For example: a red label or sticker dot to signify higher concentrations and green label for lower dosage on-hand.

3) Team member checking: Build a review of medications on-hand (including those mixed by staff) into the already standard team-based, documented Time Out.