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Start the year off right by addressing these Top 10 Medication Safety Concerns from 2021

Last year began with such hope. Thanks to the availability of coronavirus disease 2019 (COVID-19) vaccines, society began to gradually return to life as we knew it prior to the pandemic. Sadly, our emergence from the pandemic was delayed with the spread of the delta and omicron variants, shaking our confidence and overwhelming our healthcare providers once again. As we reflect on our newsletters in 2021 and the topics we wrote about last year, is it any wonder that errors with the lifesaving COVID-19 vaccines emerged at the top of the list of the Top 10 Medication Safety Concerns from 2021? We believe these medication safety concerns warrant continued attention and priority in 2022, especially if you have not already taken steps to mitigate them.

1. Mix-ups between the pediatric and adult formulations of the Pfizer-BioNTech COVID-19 vaccines

Late in 2021, after the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11 years, we began to receive reports of mix-ups between the formulation for ages 5 through 11 years (orange cap and label border) and the formulations for individuals 12 (or 16) years or older (purple cap and label border or gray cap and label border, brand name of FDA-approved vaccine is COMIRNATY) (November 4, 2021; November 18, 2021; December 6, 2021). The labels are not well differentiated, and once the caps are removed, the color difference is less apparent. Even the dose in mcg is not listed on the vaccine labels, which would likely help to differentiate the pediatric and adult formulations. Some of the vaccine mix-ups were due to look-alike vial or syringe mix-ups. In other cases, healthcare providers mistakenly believed it was acceptable to administer a smaller or diluted dose of the vaccine formulation intended for individuals 12 years or older to children ages 5 through 11 years. These mix-ups may have scared people, increased vaccine hesitancy, and weakened public health efforts to get children vaccinated. 

To prevent mix-ups, separate the different formulations and label the storage bins. Never use vaccine vials formulated for individuals ages 12 (or 16) years or older (purple or gray cap) to prepare doses for children ages 5 through 11 years. Use barcode scanning during vaccine preparation and apply labels to vaccine syringes that differentiate between adult and pediatric doses. Only bring the intended vaccine(s) for one patient at a time into the vaccination area and include the parent/patient when verifying the prepared vaccine. Ideally, barcode scanning should be employed prior to administration. Document the lot number and expiration date prior to vaccine administration, and document administration afterwards. Report any vaccination errors to the FDA Vaccine Adverse Event Reporting System (VAERS), which is mandatory for COVID-19 vaccines under an EUA, and to the ISMP National Vaccine Errors Reporting Program (ISMP VERP).    

2. Mix-ups between the COVID-19 vaccines or boosters and the 2021-2022 influenza (flu) vaccines

Once the 2021-2022 flu vaccine became available in September 2021, health authorities strongly encouraged people to receive both the flu vaccine and the COVID-19 vaccine during the same visit. Unfortunately, once the flu vaccine was available, mix-ups between the flu and COVID-19 vaccines started happening (October 7, 2021). Many of the reported errors occurred in outpatient pharmacies, with patients who consented to a flu vaccine receiving a COVID-19 vaccine instead, or vice versa. Some of the mix-ups were associated with unlabeled syringes or labeled syringes that were next to each other in vaccination areas. Other mix-ups were linked to interruptions or distractions, or staffing shortages that led to managing dispensing and vaccination responsibilities simultaneously.

To prevent mix-ups, schedule vaccinations for a dedicated block of time each day and ensure adequate staffing. Staff should not be expected to accomplish both vaccine administration and other responsibilities simultaneously. Provide a separate area for vaccine administration, away from distractions and interruptions. Use barcode scanning during vaccine preparation and label all prepared syringes. Before vaccine administration, ask the patient which vaccine(s) they have requested, and verify the vaccine(s) with signed consent form(s). Only bring the intended vaccine(s) for one patient at a time into the vaccination area and include the parent/patient in verifying the prepared vaccine(s). Ideally, barcode scanning should occur prior to administration. Document the lot number and expiration date prior to administration, and document administration afterwards. If a mix-up occurs, apologize to the patient and provide the intended vaccine before they leave the vaccination area (or ask the patient to return to the vaccination site). Report any vaccination errors to FDA VAERS and ISMP VERP.

3. EPINEPHrine administered instead of the COVID-19 vaccine

Numerous mix-ups between EPINEPHrine injection and the COVID-19 vaccine have been reported. According to the Centers for Disease Control and Prevention (CDC), EPINEPHrine injection should be readily available to treat anaphylactic reactions to the COVID-19 vaccines. Most of the mix-ups occurred between look-alike, predrawn syringes of EPINEPHrine and the vaccine (April 8, 2021). Also, ADRENALIN (EPINEPHrine) vials from Par Pharmaceutical look very similar to the Pfizer-BioNTech COVID-19 vaccine formulation for 12 years and older with the purple cap (June 3, 2021) and could easily be confused. Both vials are about the same size and shape, with purple caps and mostly black print on white labels.  

Vaccination sites should only stock EPINEPHrine autoinjectors, which look different than predrawn vaccine syringes. With training, the autoinjectors are easy to use in an emergency. Doses of EPINEPHrine and vaccine should be kept in different storage locations but close enough to vaccinators so they can be quickly retrieved when needed. Consider storing EPINEPHrine autoinjectors in an anaphylaxis kit with a tear-off lock. Ideally, utilize barcode scanning of vaccines and EPINEPHrine autoinjectors prior to administration. 

4. Preparation errors with the Pfizer-BioNTech purple cap or gray cap COVID-19 vaccines

Early in 2021, we published reports of dilution errors with the Pfizer-BioNTech COVID-19 vaccine (purple cap), which resulted in administering too much or too little vaccine (January 14, 2021January 28, 2021April 22, 2021)  In many cases, practitioners used too little diluent (often 1 mL instead of 1.8 mL), too much diluent, or diluted the vaccine vial twice. In other cases, the vaccine was administered without dilution, the wrong diluent was used (often sterile water instead of 0.9% sodium chloride), or 1.8 mL of air in a syringe was used to “dilute” the vaccine. 

In August 2021, a Pfizer-BioNTech COVID-19 vaccine, Comirnaty, was approved by FDA for the prevention of COVID-19 in individuals 16 years of age and older. Today, FDA-approved Comirnaty is available with either a purple or gray cap. Comirnaty in a vial with a purple cap requires dilution; Comirnaty in a vial with a gray cap MUST NOT be diluted prior to use. The Pfizer-BioNTech vaccine with a purple or gray cap is also available under an EUA, for individuals 12 through 15 years of age and for the administration of a booster dose (or a third dose for immunocompromised individuals). The   purple-capped EUA vaccine requires dilution prior to use, and the gray-capped EUA vaccine MUST NOT be diluted. So both Comirnaty (purple or gray cap) and the EUA vaccines (purple or gray cap) are simultaneously available. Although we have not received any error reports yet, we worry that these vaccines will be mixed up during preparation, resulting in not diluting the purple-capped vaccine as required, or erroneously diluting the gray-capped vaccine.

To avoid mix-ups between the purple- and gray-capped vaccine vials, do not store them together in the refrigerator during or after thawing (e.g., use separate shelves). To prevent dilution errors, have the pharmacy prepare and dispense predrawn, labeled syringes of the vaccine if feasible within the timeframe for stability at room temperature. If preparing either the purple- or gray-capped vaccine outside of the pharmacy, require an independent double check of the preparation process. When preparing the vaccine syringes, remove syringes from their packaging one at a time, immediately before drawing up diluents or doses; do not open syringe packages ahead of time and/or fill the syringes with air in preparation for later dose or diluent withdrawal. Educate pharmacy and vaccination staff regarding the common types of errors that may occur, including those described above. Provide those who prepare the vaccines with an updated Fact Sheet for the EUA vaccines (gray cap for 12 years and olderpurple cap for 12 years and older) or the package insert for Comirnaty, and verify their competency regarding vaccine preparation.

5. Errors and delays with hypertonic sodium chloride

Using hypertonic sodium chloride has become the standard of care to manage elevated intracranial pressure (ICP) or to reduce cerebral edema (CE) in both adult and pediatric patients with certain neurological brain injuries. During a 2021 Medication Safety Officers Society (MSOS) Briefing, we learned that facilities frequently using hypertonic sodium chloride for treating elevated ICP and CE were experiencing delays in treatment while awaiting pharmacy preparation and dispensing (November 4, 2021). For many years, ISMP has recommended NOT stocking vials/ampules of hypertonic sodium chloride in patient care units, particularly in automated dispensing cabinets (ADCs). However, we suggested that appropriately labeled and sequestered bags of 3% sodium chloride may be stocked in limited quantities in critical care/emergency care units. Nevertheless, since hypertonic sodium chloride, especially 23.4% sodium chloride, is used during an emergency, treatment delays can be significant.

To promote safety and allow for the rapid administration of hypertonic sodium chloride solutions in emergencies, in 2021 we recommended stocking limited quantities of 3% sodium chloride infusions in certain approved critical care/emergency care units after conducting a risk assessment. We also recommended labeling the bags with a customized high-alert medication label and bold warnings to draw attention to the hypertonic solution, storing them in a separate locked-lidded ADC compartment, and not allowing access via override. We also continued to recommend stocking 23.4% sodium chloride only in the pharmacy, defaulting all hypertonic sodium chloride orders to “stat” to speed pharmacy verification, preparing doses in the pharmacy labeled with warnings, and hand-delivering each dose to the practitioner administering the drug. However, for hospitals without 24-hour pharmacy services to accomplish timely dispensing of this emergency drug, we recommended stocking a limited quantity of 23.4% sodium chloride vials or syringes with special labeling and warnings in a single, secure critical care location that only a few trained professionals can access after pharmacy hours for emergencies. Override access for a few trained professionals to obtain 3% sodium chloride infusions from an ADC may also be necessary in facilities without 24-hour pharmacy review of orders. Other recommendations to avoid errors with hypertonic sodium chloride can be found in the November 4, 2021 article.

6. Errors with discontinued or paused infusions

In 2021, ISMP published harmful errors involving discontinued high-alert medication infusions, including infusions of fentaNYL, norepinephrine, and oxytocin, that had not been disconnected from patients and were inadvertently restarted, often requiring medical treatment or causing death. While keeping the same medication bag may save time and resources if a discontinued or paused medication infusion is needed again later, safety comes first.

Discontinued infusions should be immediately disconnected from the patient, removed from the pump, and discarded. Stopped or paused infusions also should be immediately disconnected from the patient, removed from the pump, and discarded within a reasonable timeframe if not restarted. When starting any medication infusion, labels with the drug name and route of administration should be affixed to each access line at the distal end of the tubing closest to the patient and on the tubing above the pump or channel (or visible on the pump screen). Prior to starting or changing the rate of an infusion, the tubing should be traced from the solution container to the pump, and then to the patient for verification. Strive to implement bi-directional smart infusion pump interoperability with the electronic health record to reduce pump programming errors.

7. Infection transmission with shared glucometers, fingerstick devices, and insulin pens

With increasing regularity, unsafe practices have been associated with outbreaks caused by transmission of infectious diseases during assisted blood glucose monitoring (using a shared glucometer for multiple patients) and insulin administration (July 1, 2021CDC article; The Joint Commission article). These unsafe practices are associated with failures in the most basic principles of infection control:

  • Using a fingerstick (lancing) device for more than one person

  • Using a glucometer for multiple patients without cleaning and disinfecting it after every use

  • Failing to change gloves and perform hand hygiene between fingerstick procedures

  • Using an insulin pen for more than one person

Fingerstick devices should never be used for more than one person, even those marketed for multi-patient use. Single-use fingerstick devices are disposable and prevent reuse through an auto-disabling feature. Whenever possible, glucometers should not be shared. If they must be shared, each device should be cleaned and disinfected per the manufacturer’s instructions after every use. The glucometer must be cleaned before it can be disinfected, which might require the repeated application of an approved cleaning agent. If the manufacturer does not specify how the device should be cleaned and disinfected, then the glucometer should not be shared. Insulin pens should never be used for more than one patient, even if the needle has been changed.

8. Adverse glycemic event errors

ECRI and the ISMP Patient Safety Organization (PSO) analyzed 100 harmful glycemic events that led to or occurred during a medical emergency (December 1, 2021). Key contributing factors associated with these events included the following:

  • Omissions or delays in initiating glycemic management protocols

  • Mix-ups caused by look-alike insulin names or vials

  • Insulin administration without consideration of dietary intake

  • Omissions or delays in glucose monitoring and nutritional intake

  • Communication breakdowns

  • Inaccurate home medication lists and untimely medication reconciliation

To minimize adverse glycemic events, establish standardized protocols or order sets to guide the treatment and monitoring of clinically significant hypoglycemia and hyperglycemia. Ensure appropriate rescue agents are readily available and establish protocols or coupled order sets that permit their emergency administration. Avoid close storage of insulin with look-alike names or labeling and use tall man letters to distinguish the unique letters of look-alike insulin brand names. Upon patient admission, capture a thorough medication history, require timely medication reconciliation, and prescribe necessary home medications. Conduct an assessment of patients receiving insulin to identify patients at high risk for developing hypoglycemia or hyperglycemia and target them for preventative interventions. Coordinate meal delivery with glucose monitoring and insulin administration, and assess the patient’s nutritional intake before giving insulin. Use barcode scanning prior to drug administration. Initiate glycemic management protocols/order sets for patients who experience a blood glucose value above or below a specific target value. 

9. Every organization needs a medication safety officer

Despite past achievements in medication safety, continuous changes in healthcare have introduced unintended consequences and new challenges that compromise medication safety. A medication safety officer (MSO) is a dedicated clinical medication safety advocate armed with education, authority, and leadership skills, who serves as the organization’s authoritative expert in safe medication use for the purpose of reducing patient harm. However, as of 2018, only about half of US hospitals had created MSO positions to address ongoing medication safety challenges.

The MSO position is not merely a title change for an existing position, and the role cannot be covered by other practitioners simply by adding “medication safety” to their job description. Quite the opposite, healthcare executives should hire a qualified, dedicated MSO, empower them to act on medication safety concerns, and position the MSO on the organizational chart where it will best enable their ability to affect change. This helps to ensure that the organization will identify and learn from medication risks and errors (both internal and external), and implement high-leverage strategies to reduce or eliminate medication errors (February 25, 2021). For a medication safety program to succeed, it is essential to have an innovative and highly visible MSO to set a vision and direction, identify opportunities for improvement, and coordinate the implementation of error-prevention strategies. Without MSOs, medication safety tasks are rarely prioritized, and those with high impact are infrequently addressed.

10. Increasing error reporting

Error-reporting systems are an important tool for improving patient safety and often represent the primary means of learning about hazards and errors. But encouraging staff to submit reports is not easy given the potential disincentives to reporting, including embarrassment, the perception that reporting is not worth their time, or if reporting is time consuming, confusing, or complex. Furthermore, the workforce is understandably reluctant to report errors if they are worried that the information will get them in trouble, impact their job, or lead to the perception of being careless or incompetent.

Some highly functional error-reporting systems exist today from which best practices that promote error reporting can be identified (August 26, 2021). These best practices fall into nine categories that impact the quantity and quality of reports: 

  • Trustworthiness: Earning reporters’ trust and proving the leaders’ dependability

  • Open, fair, and learning culture: Reporting without fear of being treated unfairly

  • Confidential: Keeping the identity of reporters and involved staff confidential

  • Clear: Defining the types of hazards and errors, including close calls, to be reported

  • Easy: Making the reporting process exceedingly easy and readily accessible

  • Credible and useful: Avoiding inaction and using the report to improve safety

  • Rewarding: Recognizing reporters for playing a positive role in patient safety

  • No severity bias: Not allowing the severity of the outcome to influence the response

  • Reinforced imperative: Mentoring new and existing staff about reporting