Patient Safety Tip of the Week Archive

Patient Safety Tip of the Week

November 19, 2019

An Astonishing Gap in Medication Safety

We’ve made remarkable progress in preventing medication errors in the hospital setting. Tools include barcoding, CPOE with clinical decision support, double checks, segregation of LASA (look-alike sound-alike) drugs in storage, ADC’s (automated dispensing cabinets) with alerts, “Do Not Disturb” vests to minimize distractions and interruptions during nurse medication rounds, smart pumps, and others. But those valuable tools are not used in multiple other healthcare venues. Recent incidents have highlighted gaps in medication safety in community vaccination programs.

This month ten people at a group home in Oklahoma were to have flu shots but were instead erroneously administered insulin (Watts 2019, Lee 2019, Giles 2019). This followed another incident just weeks earlier in which 16 high school students were erroneously injected with insulin instead of tuberculin testing for TB (Romine 2019, Bradley 2019).

Insulin is not the only dangerous medication erroneously administered in vaccination programs. In several of our columns on NMBA’s (neuromuscular blocking agents) we mentioned a paper (Koczmara 2007) that described an incident where atracurium was administered subcutaneously instead of hepatitis B vaccine to seven infants. The infants developed respiratory distress within 30 minutes. Five infants recovered, one sustained permanent injury, and another died. And in a 2014 incident in Syria, approximately 75 infants received the NMBA atracurium, instead of the measles vaccine and 15 of the infants died as a result (Kroll 2014).

The most recent insulin incident, involving 8 residents of the group home plus 2 staff members, resulted in hospitalization of all 10 people. Emergency responders found multiple unresponsive subjects at the scene. The situation was even more complicated because many of the group home residents were incapable of communicating their symptoms and needs. Apparently, the insulin preparation was a long-acting one, so several people had to be hospitalized for more than a day. The pharmacist who injected the insulin had over 40 years of experience and was a contractor who went to the facility to administer the flu shot to residents and employees.

We don’t have many details of how things went wrong in these two recent incidents, but we’ll comment in general about some of the things that could go wrong in such incidents.

Obviously, look-alike vials probably played a role. It is easy to imagine how a vial of insulin might be mistaken for a vial containing a vaccine. That is why storage of vaccines in proximity to other potentially dangerous medications is problematic. Note that in the first NMBA paper (Koczmara 2007) neuromuscular blocking agents had never been available as floor stock in the nursery. For convenience, an anesthesiologist from a nearby OR had placed the vial of atracurium in the unit refrigerator near vaccine vials of similar appearance. In the current Oklahoma incident, storage may well have played a key role. One individual at the home was apparently on insulin, and it is believed that the pharmacist accidentally grabbed the insulin out of the fridge in the group home's medicine room instead of the flu vaccine that he intended to give (Giles 2019).

In the incident where insulin was mistaken for tuberculin, both the insulin and tuberculin were apparently stored in the school nurse’s office (Bradley 2019). Media reports did not detail if they were stored in proximity or whether they were segregated.

So, a key lesson learned is that, while your own hospital or pharmacy may take steps to segregate insulin or other potentially dangerous medications from vaccines, such may not be the case when some other facility (group home, school, etc.) is storing the vaccine.

The other obvious question in the Oklahoma incident is “Didn’t the pharmacist look at the label?”. Unfortunately, many adverse medication events occur because someone failed to look at labels. That is why barcoding has been such an important contribution to medication safety in hospitals. But in the group home setting there was no electronic medical record or CPOE capability and no barcoding capability so there was no opportunity to warn the pharmacist the wrong drug/substance was about to be used.

While not applicable to the current incident, note that it is conceivable that someone could look at the vial of a vaccine at the time of administration and confirm it is the correct vaccine but still be administering a dangerous product. In the Syrian incident noted above (Kroll 2014), it was suspected that the mix-up with atracurium occurred with the solution used to reconstitute or dilute the measles vaccine. That's usually a sterile saline solution packaged together with the dried vaccine. One could picture how insulin could be mistakenly used as a diluent for any of those vaccines requiring diluents and then the person administering the vaccine would only see the label on the vaccine vial and assume that is correct.

Given that there was no barcoding as a layer of defense, you might fall back on an old technique – the independent double check. We’ve done several columns on double checks, noting that they are not infallible. They are used most often when dealing with high risk medications. But perhaps in settings lacking barcoding it may make sense to have a second person confirm the vaccine/medication being given. It sounds like the pharmacist in the Oklahoma incident was the only healthcare professional present. In hospitals, having a second set of eyes is useful even if independent double checks are not being used. Typically, a pharmacist prepares and dispenses the medication and then a nurse checks it before administering it. In the current incident there was only one person preparing and administering the vaccine.

That the pharmacist was likely solo also raises the question about monitoring after vaccine administration. Was he appropriately trained to respond to any adverse consequence of a “vaccination”? Was his attention diverted from those who had already received the “vaccination”?

In hospitals, we also try to ensure that nurses administering medications are free of distractions and interruptions. That means they are often freed up from other nursing responsibilities during medication administration and they may also use “Do Not Disturb” vests. It’s not known whether there may have been distractions or interruptions in the group home setting.

So, we wondered “Are there guidelines for doing mass vaccination programs?”. There are. The CDC has published “Guidelines for Large-Scale Influenza Vaccination Clinic Planning” (CDC 2015). The CDC guideline also has a link to a valuable skills checklist from Immunize.org for those administering the vaccines. CDC also has a “Vaccine Storage and Handling Toolkit” and Immunize.org also has a nice “Checklist for Safe Vaccine Storage and Handling”. Immunize.org has a wealth of valuable materials for those providing immunizations. One of their resources is a handout “Don’t Be Guilty of These Preventable Error s in Vaccine Administration!”, which describes common mistakes in vaccine administration.

Maybe someday computerized order entry and barcode scanning will be available in all settings. We’ll be using biometric identification, and everyone will have on record a scan of their finger or palm prints or retina or iris so we can avoid patient misidentification and we can barcode to ensure correct medications or vaccines are being given. But until that time, we need to look at how we deliver vaccinations.

If your organization provides vaccinations, what should you be asking, given the lessons in these incidents?

- Do you store your vaccines in a location separate from other medications that might be dangerous?

- Do you ever send your staff to a location that stores its own vaccines and other medications?

- Is any diluent intended for use with each vaccine stored with the vaccine so no one might use a vial of a different solution as a diluent?

- Do you use independent double checks? Prior to administration? Prior to preparation?

- If not true independent double checks, are at least 2 people involved in the process?

- Is the person administering the vaccine ever solo?

- How do you minimize distractions/interruptions at the location?

- What are your routines for monitoring patients after vaccination?

- How do you screen those who have impaired ability to communicate for contraindications?

- How do you monitor those who have impaired ability to communicate?

- Do you use a skill set checklist like the one noted above?

- How do you document vaccinations?

There are obviously many other considerations in vaccine programs. We are only considering some of the safety issues associated with the processes of vaccine programs. We refer you to many other good resources involving all those other vaccination program issues, such as the CDC guidelines, Immunize.org resources, and ACIP (ACIP, Ezeanolue 2019) recommendations.

Fortunately, such serious incidents related to vaccination are very rare, but now is a good time for all organizations that provide vaccinations to review their practices. This is a good topic for a FMEA (Failure Mode and Effects Analysis) to identify potential vulnerabilities.

References:

Watts A, Spells A. 10 hospitalized after insulin administered instead of flu shots. CNN 2019; November 8, 2019

https://www.cnn.com/2019/11/07/us/oklahoma-flu-shot-mix-up/index.html

Lee BY. 10 People Got Insulin Instead Of The Flu Shot. Forbes 2019; November 8, 2019

https://www.forbes.com/sites/brucelee/2019/11/08/10-people-got-insulin-instead-of-the-flu-shot/#365e0bfa2be9

Giles G. Insulin Case Being Handled by Board of Pharmacists. Bartlesville Radio 2019; November 14, 2019

http://www.bartlesvilleradio.com/pages/news/219932019/insulin-case-being-handled-by-board-of-pharmacists

Romine T. 16 students in Indiana were accidentally injected with insulin during a TB test, school district says. CNN 2019; September 30, 2019

https://www.cnn.com/2019/09/30/health/16-students-accident-indiana/index.html

Bradley D, Sánchez R, Ridle C. Student, mother intend to sue after insulin mix-up at McKenzie Center. Theindychannel.com 2019; October 3, 2019

https://www.theindychannel.com/news/working-for-you/lawsuit-being-filed-after-student-has-adverse-reaction-to-insulin-mix-up-at-mckenzie-center

Koczmara C, Jelincic V. Neuromuscular blocking agents: Enhancing safety by reducing the risk of accidental administration. ISMP Canada 2007 in the Spring 2007 publication of the Canadian Association of Critical Care Nurses (CACCN).

http://www.ismp-canada.org/download/CACCN-Spring07.pdf

Kroll D. Vaccine Mix-Up In Syria Not Uncommon In US, Canada. Forbes 2014; September 18, 2014

https://www.forbes.com/sites/davidkroll/2014/09/18/syrian-infant-deaths-vaccine-mixups-with-atracurium-not-uncommon/#35a1048d59a0

CDC. Guidelines for Large-Scale Influenza Vaccination Clinic Planning. CDC 2015; December 16, 2015

https://www.cdc.gov/flu/professionals/vaccination/vax_clinic.htm

Immunize.org

https://www.immunize.org/

(Immunize.org)

Immunize.org. Skills Checklist

https://www.immunize.org/catg.d/p7010.pdf

Immunize.org. Don’t Be Guilty of These Preventable Error s in Vaccine Administration!

https://www.immunize.org/catg.d/p3033.pdf

CDC. Vaccine Storage and Handling Toolkit. CDC

https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

Immunize.org. Checklist for Safe Vaccine Storage and Handling.

https://www.immunize.org/catg.d/p3035.pdf

ACIP (Advisory Committee on Immunization Practices). ACIP Vaccine Recommendations and Guidelines.

https://www.cdc.gov/vaccines/hcp/acip-recs/index.html

Ezeanolue E, Harriman K, Hunter P, Kroger A, Pellegrini C. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Accessed on November 16, 2019.

https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf

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