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News Release

Errors with COVID Vaccines Lead ISMP’s of Medication Safety Concerns from 2021

ISMP has released a list of the top 10 medication errors and hazards covered in its acute care newsletter in 2021. The list focuses on safety problems that are frequently reported, have caused serious harm to patients, and could be avoided or minimized with system and practice changes attainable by all healthcare providers. ISMP believes that these issues merit attention and priority if action has not already been taken to mitigate risk.

Four out of the 10 categories identified involve errors with COVID-19 vaccines. ISMP President Rita K. Jew, Pharm.D., MBA, BCPPS, FASHP, emphasizes the toll that the ongoing pandemic has taken on fatigued healthcare providers and medication safety. “We realize that healthcare organizations are overwhelmed, struggling to cope with COVID surges and related challenges,” she says. “This year’s top ten list provides specific, practical prevention recommendations, especially for COVID-19 vaccine-related errors, and highlights other issues that can be turned to and addressed in the longer term when organizations are more able to devote the time.”

ISMP hopes that the following hazards and errors become part of healthcare organizations’ medication safety improvement plans:

ISMP Top 10 Medication Errors and Hazards List for 2021

  • Mix-ups between different formulations of the Pfizer-BioNTech COVID-19 vaccine. ISMP has received ongoing reports of mix-ups between the age 5-11 formulation and the formulation for individuals 12 years or older or 16 years or older. Although the caps and label borders are different colors, once caps are removed the difference is less apparent and the labels do not prominently indicate age ranges. Other mistakes have been due to syringe mix-ups or healthcare providers mistakenly thinking it was acceptable to administer a smaller or diluted dose of the vaccine for individuals 12 or older to children ages 5 through 11.

  • Mix-ups between COVID-19 vaccines or boosters and influenza (flu) vaccine. Health authorities recommended administering both the flu and COVID-19 vaccines or boosters together at the same visit--unfortunately, this has led to mix-ups, especially in outpatient pharmacies. Mix-ups have been associated with unlabeled syringes, labeled syringes sitting next to each other in the vaccination area, interruptions or distractions during preparation and administration, and staffing shortages.

  • EPINEPHrine administered instead of COVID-19 vaccine. Numerous mix-ups between EPINEPHrine injection and COVID-19 vaccines have been reported, as EPINEPHrine should be readily available to treat anaphylactic reactions. Most mix-ups have occurred between look-alike, pre-drawn syringes, both labeled but within arm’s length of the vaccinator. Also, ADRENALIN vials from Par Pharmaceutical look similar to the Pfizer-BioNTech vaccine with the purple cap and could be easily confused.

  • Preparation errors with Pfizer-BioNTech COVID-19 vaccine. ISMP has published reports of dilution errors with the Pfizer-BioNTech vaccine that resulted in administering too much or too little. In many cases, practitioners used the wrong volume of diluent or diluted the vaccine vial twice. If too much diluent is used, doses may be ineffective; if too little diluent is used, doses may invoke stronger adverse effects. In several cases, the vaccine was administered using the wrong diluent or using air in a syringe to “dilute” it.

  • Errors and delays with hypertonic sodium chloride. Using hypertonic sodium chloride has become the standard of care to manage elevated intracranial pressure or reduce cerebral edema in patients with certain neurological injuries. During 2021, most errors with hypertonic sodium chloride reported to ISMP were associated with mix-ups between 0.9% sodium chloride and hypertonic sodium chloride, often when compounding, stocking, or prescribing, or when programming infusion pumps.

  • Errors with discontinued or paused infusions. In 2021, ISMP published harmful errors involving discontinued high-alert medication infusions that had not been disconnected from patients and were inadvertently restarted, often requiring medical treatment or causing death. While a discontinued or paused medication infusion may be needed again later and keeping the same medication bag may save time and resources, safety should come first.

  • Infection transmission with shared glucometers, fingerstick devices, and insulin pens. Increasingly, unsafe practices such as using devices for more than one person have led to outbreaks caused by transmission of hepatitis B virus, hepatitis C virus, HIV, and other infectious diseases during assisted blood glucose monitoring and insulin administration.

  • Adverse glycemic event errors. ECRI and the ISMP Patient Safety Organization analyzed 100 harmful adverse glycemic events that led to or occurred during a medical emergency and identified key contributing factors, including delays in initiating management protocols or monitoring, mix-ups between insulin names or vials, communication breakdowns, inaccurate home medication lists, and untimely medication reconciliation.  

  • Organizations lacking a medication safety officer. Continuous changes in healthcare constantly introduce new challenges that compromise medication safety. A medication safety officer (MSO) is a dedicated clinical advocate who can serve as an organization’s expert in safe medication use and reduce patient harm. Unfortunately, as of 2018, only about half of U.S. hospitals had created an MSO position to ensure high-leverage strategies are being implemented to reduce risks.

  • Failure to increase error reporting. Error-reporting systems are an important tool for learning about medication hazards, errors, and prevention strategies. But barriers to effective reporting still remain in some healthcare organizations due to leadership inaction, unnecessary complexity, or staff misperceptions that it may lead to punitive action.


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