Implement Changes to Minimize These 2 Hazards

April 14, 2021
Michael J. Gaunt, PharmD

Pharmacy Times, April 2021, Volume 89, Issue 04
Pages: 34

Errors related to extended-release opioids and COVID-19 vaccines warrant attention and should be a priority.

Even as health care providers and patients continue to battle the coronavirus disease 2019 (COVID-19) pandemic and its accompanying challenges, medication safety issues.

Here we focus on 2 issues that warrant attention and priority to mitigate risks. These are errors and hazards that have been persistent but can be avoided or minimized with system and practice changes.

Extended-Release Opioids

Inappropriate prescribing of extended-release (ER) opioids to opioid-naïve patients has resulted in serious harm and death. The Institute for Safe Medication Practices (ISMP), as well as the FDA, have warned practitioners about this well-known problem for decades. However, inappropriate opioid prescribing continues to occur, often because of a knowledge deficit about the dangers associated with prescribing ER opioids to opioid-naïve patients and/or not understanding the difference between opioid-naïve and opioid-tolerant. For example, in 2020, the ISMP published several new reports related to prescribing fentanyl patches to elderly, opioid-naïve patients, sometimes to treat acute pain or because of a codeine “allergy” that was a minor drug intolerance.1 Fentanyl patches should be prescribed to opioid-tolerant patients only for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. This is so critical to safety that, in 2018, the ISMP called for the elimination of prescribing fentanyl patches to opioid-naïve patients and/or patients
with acute pain in the ISMP Targeted Medication Safety Best Practices for Hospitals.2 In 2020, this best practice was incorporated into a new best practice to verify and document the patient’s opioid status and type of pain before prescribing and dispensing ER opioids. Here are some best practices:

  • Develop and implement a standard process for gathering and documenting each patient’s opioid status and type of pain if pain is present.
  • Distinguish between drug intolerances and true allergies when collecting allergy information.
  • Eliminate the storage of fentanyl patches in automated dispensing cabinets or as unit stock in clinical locations where primarily acute pain is treated, such as in the emergency department, operating room, postanesthesia care unit, or procedural areas.
  • Ensure that order entry systems should default to the lowest initial starting dose and frequency when initiating orders for ER opioids, and interactive alerts should be built to confirm opioid tolerance when pre- scribing and dispensing ER opioids.
  • Establish definitions for opioid-naïve and opioid-tolerant patients.

COVID-19 Vaccines

Findings from the analysis of recent influenza vaccine errors can be used to prevent mistakes during the COVID-19 vaccine campaigns that started in December 2020. Common contributing factors associated with flu vaccine errors that could also be risk factors for COVID-19 vaccinations include dilution or mixing errors; look-alike vaccine names, labels, and packaging; not checking or documenting administration in the immunization information system; and unsegregated freezer or refrigerator/storage.3 Two other vaccine error–related contributing factors often reported to the ISMP are communication barriers with patients and temperature excursions, and they may also affect COVID-19 vaccination efforts.

The ISMP also reviewed early COVID-19 vaccine errors voluntarily reported to its ISMP National Vaccine Errors Reporting Program.4 Numerous dilution errors with the Pfizer-BioNTech vaccine have led to overdoses when too little diluent was used, often 1 mL instead of 1.8 mL. In 2 cases, patients received the entire vial contents without dilution. In a clinic, patients received intramuscular injections of Regeneron’s monoclonal antibody casirivimab instead of the Moderna COVID-19 vaccine because of vague labeling of the monoclonal antibody, which included a product code name, not the established name. Wasted vaccines from inefficient scheduling or no-shows were reported, as was administration of the vaccine to patients younger than indicated.

Here are some things to keep in mind:

  • Arrange vaccination sites to have enough space to assess patients before vaccination, observe them after vaccination, and treat patients who experience a reaction, all while
    maintaining social distancing and other pandemic measures.
  • Ensure the vaccine scheduling process includes a reliable system to confirm appointments.
  • Establish a standard process for dealing with leftover doses at the end of the day.
  • Prepare to immediately treat allergic reaction at all vaccination sites.
  • Provide vaccinators with a fact sheet for the vaccine(s) being used and verify their competency regarding vaccine storage and preparation, patient assessment, identification of the proper vaccine injection site, administration, and emergency treatment of anaphylaxis.


Michael J. Gaunt, PharmD, is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/Ambulatory Care newsletter at the Institute for Safe Medication Practices in Horsham, Pennsylvania.


  1. Inappropriate fentanyl patch prescriptions at discharge for opioid-naïve, elderly patients. Institute for Safe Medication Practices. July 2, 2020. Accessed March 15, 2021. https://ismp. org/resources/inappropriate-fentanyl-patch-prescriptions-discharge-opioid-naive-elderly-patients
  2. Targeted medication safety best practices for hospitals. Institute for Safe Medication Practices. February 21, 2020. Accessed February 10, 2021.
  3. Gaunt MJ. What factors contribute to influenza vaccine errors. Pharmacy Times®. February 16, 2021. Accessed March 15, 2021. ute-to-influenza-vaccine-errors
  4. Learning from errors with the new COVID-19 vaccines. Institute for Safe Medication Practices. January 14, 2021. Accessed March 15, 2021. 19-vaccines