#213 Medication Labeling Errors and Anesthesia for Patients with Concussions

Before we dive into the episode today , we'd like to recognize Eagle Pharmaceuticals , a major corporate supporter of APSF . Eagle Pharmaceuticals has generously provided unrestricted support to further our vision that no one shall be harmed by anesthesia care . Thank you , Eagle Pharmaceuticals . We wouldn't be able to do all that we do without you .

First up , we want to highlight a recent ISMP alert that was published on July 11 , 2024 . Manufacturers' dexmedetomidine pre-mixed IV bags may be packed within an overwrap labeled as acetaminophen . To follow along with us , head over to APSForg and click on the Patient Safety Resources heading . The fifth one down is news and updates .

Then scroll down until you get to our featured article today . I will include a link in the show notes as well . This is a notice about a Hikma product that was packaged with a label for acetaminophen injection 1,000 milligrams in 100 mLs , which may contain dexmedetomidine 400 mLs in 100 mLs infusion bag with Canadian labeling .

A different font and , according to the ISMP , Canada's Tall man Lettering lowercase d-e-x-m-e-d-e , capital T , capital O , capital M and lowercase i-d-i-n-e .

Note that this is different from the Tallman lettering on the ISMP list of lookalike drug names , which recommend Tallman mixed case letters , which reads as lowercase d-e-x-m-e-d-e with capital T-o-m-i-d followed by lowercase i-n-e .

Please see the show notes for the product and lot numbers and expiration dates and check out figure 1 and figure 2 in the article for pictures of these products and figure 2 in the article for pictures of these products .

This is a big threat to patient safety , as evidenced by the case that was reported to ISMP , when a nurse removed what appeared to be acetaminophen 1,000 milligrams in a 100 ml infusion bag from the automated dispensing cabinet , scanned the barcode of the overwrap and administered the infusion to the patient .

15 minutes later , the patient developed bradycardia and bradypnea . Inspection of the empty infusion bag revealed a bag labeled dexmedetomidine 400 mics in 100 mLs . The patient recovered from this event and the nurse notified the clinician .

The FDA and HICMA were notified of this event and HICMA is conducting an immediate investigation with a quarantine of lot 24070381 acetaminophen 1000mg in 100 mL infusion bags . A formal recall is planned as well If your organization has ordered this product .

It is important to check for overwrap labeled acetaminophen with lot number 24070381 and do not use these products until further instructions from the FDA or wholesaler . Keep in mind that the best practice is to scan the barcode directly on the infusion bag , rather than the overwrap , before administering the medication to the patient .

In addition , education should be provided about how to read the infusion bag labels before scanning with the barcode and administering the medication to the patient . It is especially important to check all HICMA's acetaminophen infusion bags , no matter what the lot number , and to report any issues to ISMP , the FDA and the manufacturer .

Check out the show notes for links to all of these organizations . And now it's time to head back into the APSF archives to talk about keeping patients with concussion safe during anesthesia care . This is an article from the APSF Archive Show .

During this episode , we will take a look at a past article that was published in the APSF newsletter that you can find on our website . Keep in mind that things may have changed a lot since the publication of these articles , but they are of interest from our archives . Our next featured article is from the October 2018 newsletter .

It is Is a Concussed Brain , a Vulnerable Brain Anesthesia After Concussion by Arnie Absejo and Jeffrey Pasternak . To follow along with us head over to apsforg and this time click on the newsletter heading . The fourth one down is newsletter archives . Then scroll down to October 2018 newsletter and select our featured article today .

I will include a link in the show notes as well . Has this ever happened to you ? You are interviewing a patient in the preoperative holding area prior to elective surgery and the patient tells you that they've recently sustained a concussion . The patient may ask you is it safe for me to have surgery and anesthesia ?

And you may be asking yourself the same thing Is it safe for this patient to have surgery and anesthesia with a recent concussion ? Does your anesthetic plan need to change when the patient reports having a concussion ? The authors pose some additional questions .

Does the perioperative period represent a time for increased risk for brain injury in patients with recent acute concussion or chronic repeated concussion ? Should elective procedures requiring general anesthesia be delayed and , if so , for how long ? What specific complications may be attributed to anesthesia in patients with concussion ?

Are there any perioperative risk factors that can be modified to help improve patient safety ? Let's dive into the article to find out . We are learning that repeated concussions may lead to long-term cognitive deficits , and even a single concussion can cause serious neurophysiologic changes that may last for days to weeks .

It is not uncommon for patients who sustain a head trauma with and without a formal diagnosis of concussion to then require surgery and anesthesia care . Back in 2018 , there was limited data to help guide perioperative management of patients with acute concussion or chronic repeated concussions , but we definitely have a lot of questions and the APSF is here to help .

We are going to start with some definitions . A concussion involves the functional manifestations of mild traumatic brain injury that may result from any blow , jolt or strike to the cranium , with or without loss of consciousness . Concussions may occur during a sports-related injury , motor vehicle accident , fall or assault .

It may be difficult to determine an accurate prevalence for acute concussion , since patients may not seek medical care . In 2010 , the Centers for Disease Control , or CDC , estimated 2.5 million traumatic brain injuries led to emergency department visits , hospitalizations or death , and about 75 to 95% of these injuries were mild traumatic brain injuries and concussions .

Keep in mind that this data does not include outpatient office-based visits or those who did not seek medical care . Check out the show notes for a link to the CDC website for more information about traumatic brain injury and concussion , including updated data and information .

The CDC points out that mild traumatic brain injuries and concussions are serious and patients need to be seen by their doctor to help with the diagnosis , management and recovery .

With the diagnosis , management and recovery , Newer data suggests that there are about 1.7 million emergency department visits for mild traumatic brain injuries every year and an incidence of between 1.4 and 3.8 million concussions each year , including ED visits and outpatient visits , in the United States .

While we may not know the exact number of concussions every year , it is clear that this is a significant health concern and it is likely that you will need to provide anesthesia care to a patient who has sustained a concussion . Next up , let's talk about how a concussion is diagnosed .

This is a clinical diagnosis , since radiographic imaging is often non-diagnostic , non-predictive nor specific . For concussion , the most common symptom is headache .

Check out Table 1 for a list of other signs and symptoms , which may include the following , and symptoms which may include the following Headache , unsteadiness , difficulty concentrating , confusion , photophobia , nausea , drowsiness , amnesia , sensitivity to noise , tinnitus , irritability and hyper excitability .

Most of these symptoms will resolve in the first week following the injury . No-transcript . The authors describe the persistent pathophysiology of acute concussion . After sustaining a concussion , the brain is in a state of altered physiology and homeostasis . The initial changes are increased cerebral metabolic rate , which may affect consciousness .

Later changes over hours , days and weeks may involve increased blood flow , reduced metabolism and altered vascular responsiveness to changes in systemic blood pressure , arterial carbon dioxide , tension and brain activity . Functional MRI has revealed damage to and dysfunction of , neuronal axons in the brain , which may last for weeks .

Keep in mind that even after symptom resolution , the brain may not have returned to normal cerebral physiology . The first step for treatment includes stopping regular activity and being evaluated by a medical professional . The main treatment is physical and cognitive rest .

In addition , patients will be advised to refrain from activities that could increase the risk for a repeat hand injury , including sports , and to minimize activities that could result in harm , such as driving , operating heavy machinery or making important decisions .

You may have heard the term brain rest before , and this is really important , since cognitive rest helps to minimize physiologic stress on the injured brain . Back in 2018 , there was some data that mild activity after concussion can help speed up recovery .

The overall consensus is a focus on gradual return to physical and cognitive activity , while monitoring for exacerbation of post-concussive symptoms . Let's take a look at figure one in the article for a comparison of cognitive rest versus the perioperative environment On the physical and cognitive rest side .

Here are the goals for concussion therapy Minimize physical activity , Rest at home if possible . Avoid making significant decisions , Minimize activities including reading , social visits and video games , and a gradual return to activities as tolerated .

Now let's look at the anesthesia , surgery and recovery side and the perioperative demands , which include the following Exposure to foreign environments , Meet multiple new people , Meet multiple new people , Answer multiple questions , Ask to make important decisions , Bright lights , Physical transfers and movement , Pain medications and altered sleep .

As you can see , the demands of the perioperative environment conflict with the goals for concussion therapy . Another important related topic is chronic repeated concussion . Let's look at some of the data .

In 2005 and 2006 , Omalou and colleagues described the widespread deposition of beta amyloid and neurofibrillary tangles in the brains of Mike Webster and Terry Long , former professional football players . These findings are also consistent with the post-mortem findings of patients with Alzheimer's disease .

These findings of chronic traumatic encephalopathy were thought to be due to multiple , repeated concussion injuries .

Another study by Mez and colleagues looked at brains donated to the concussion legacy foundation , BrainBank , and found widespread neuropathologic findings , including depositions of beta amyloid and neurofibrillary tangles , with increasing frequency in those with longer football careers .

There were lower rates of these neurohistopathologic findings in high school-only football players and much higher rates in professional football players . When this 2018 APSF article was written , there was no data to describe cerebral physiology changes in patients with suspected chronic traumatic encephalopathy .

We still have more to talk about when it comes to keeping patients safe with concussions during anesthesia care , so we hope that you will tune in next week when we talk about anesthesia after concussion and an updated literature review . If you have any questions or comments from today's show , please email us at podcast at apsforg .

Please keep in mind that the information in this show is provided for informational purposes only and does not constitute medical or legal advice . We hope that you will visit APSForg for detailed information and check out the show notes for links to all the topics we discussed today .

If you have not done so already , we hope that you will rate us and leave a review on iTunes , Spotify or wherever you get your podcasts , and feel free to share this podcast with your friends and colleagues and anyone you know who is interested in anesthesia . Patient safety Plus .

You can let us know that you are listening by tagging us at APSForg using the hashtag hashtag APSF podcast on X . Until next time , stay vigilant so that no one shall be harmed by anesthesia care . Thank you .