Michael J. Gaunt, PharmD

As our nation conducts a large-scale coronavirus disease 2019 (COVID-19) immunization campaign, it is critically important for health care workers who administer the vaccine to understand proper intramuscular (IM) administration technique to avoid a disabling and preventable occurrence known as shoulder injury related to vaccine administration (SIRVA).

This is especially important because health care workers who may not normally give vaccinations may be called upon to help administer the new COVID-19 vaccines.

SIRVA is a shoulder injury triggered by the incorrect injection of a vaccine into the shoulder capsule (joint) rather than the deltoid muscle. It is caused by using an incorrect IM injection technique or improperly landmarking the IM injection site (the deltoid muscle) resulting in the unintended injection of the vaccine and/or trauma from the needle into and around the underlying bursa of the shoulder. The resulting inflammatory process causes injury to the musculoskeletal structures of the shoulder, such as bursae, ligaments, and tendons.

Symptoms of SIRVA include persistent shoulder pain, limited range of motion, and weakness. These typically develop within hours to a few days after receiving a vaccination. These symptoms do not improve with OTC analgesics. The resulting chronic shoulder pain and inability to carry out daily activities that were possible prior to vaccination often lead patients to seek medical intervention. Patients are often diagnosed with inflammatory shoulder injuries, such as adhesive capsulitis, bursitis, frozen shoulder syndrome, and rotator cuff tears. These do not appear any different than routine shoulder injuries, except that the shoulder symptoms started within days of an IM deltoid vaccination.

The key to avoiding SIRVA is to recognize the anatomical landmarks
for identifying the deltoid muscle and to use proper IM administration technique. Proper landmarking of the deltoid muscle requires determining the lower and upper borders of a safe injection zone. First, the patient’s shoulder should be exposed completely. When a shirt cannot be removed, the arm should be removed from the sleeve or the sleeve should be rolled up, rather than pulling the shirt’s neck over the shoulder. To ensure the injection is given below the shoulder capsule, measure 2 to 3 finger widths from the acromion (bony prominence above the deltoid) to identify the upper border of the injection zone. The lower border can be marked by
the armpit to ensure that the injection is not inserted below the deltoid muscle. Eyeballing the injection site is not acceptable. The forefinger and thumb can be used to make a V to outline the deltoid muscle and keep the injection zone visible before injecting the needle at a 90-degree angle. Injections too close to the shoulder capsule can lead to SIRVA. Injections below or too far to the side of the deltoid muscle can hit the radial or axillary nerve, respectively, which can result in neuropathy or paralysis.

Multiple resources related to proper vaccination techniques are provided by the Centers for Disease Control and Prevention and the Immunization Action Coalition.

 Many of these resources, including checklists, e-learning with continuing education credits, and videos, have been recently updated and are applicable to the COVID-19 vaccination campaign. Additionally, the University of Waterloo School of Pharmacy in Ontario, Canada, offers a helpful infographic on proper landmarking to prevent SIRVA. (www.cfp.ca/content/cfp/suppl/2019/01/18/65.1.40.DC1/SIRVA.pdf).

As noted in the fact sheets for the COVID-19 vaccine products available under an emergency use authorization (EUA) from the United States Food and Drug Administration, reporting of adverse events (AEs), including medication errors, is mandatory. Providers or their designees must report all medication errors and serious AEs using the methods noted in the specific product fact sheet and within the specified period. Errors related to the COVID-19 vaccines must be reported to the Vaccine Adverse Event Reporting System (VAERS; https://vaers.hhs.gov/). Consult the specific EUA product’s fact sheet for the required reporting method.

In addition, consider informing the Institute for Safe Medication Practices (ISMP) about any actual or potential errors involving these vaccines via email (ismpinfo@ismp.org) or the ISMP website (www.ismp.org). However, with EUA vaccines, reporting to the ISMP will not replace the need for mandatory reporting to VAERS.

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.

Bancsi A, Houle SKD, Grindrod KA. Shoulder injury related to vaccine administration and other injection site events. 

Wexler D. Prevent shoulder injuries caused by missing the deltoid muscle when injecting vaccines! Immunization Action Coalition. Updated November 19, 2020. Accessed January 10, 2021.

https://www.immunize.org/technically-speaking/20201117.asp

Wexler D. Let’s get it right! how to avoid shoulder injury with deltoid intramuscular injections. Immunization Action Coalition. Updated November 8, 2018. Accessed January 10, 2021. 

https://www.immunize.org/technically-speaking/20181023.asp

Articles

Shoulder injuries are a real concern because some health care workers may be new to administering vaccines.

Safeguard Patients During COVID-19 Immunization Campaigns

Americans have been responding to the advice of medical experts and getting influenza vaccinations in record numbers this flu season,

 which should help reduce the burden on the health care system amid the coronavirus disease 2019 (COVID-19) pandemic.

However, the Institute for Safe Medication Practices (ISMP) has seen a corresponding increase in reported flu vaccine—related errors. Since September 2020, the ISMP has received more than 60 error reports associated with the 2020-2021 flu vaccine.

The analysis of flu vaccine—related errors and other deadly or harmful vaccine mistakes from the past leads to concerns about the COVID-19 campaigns underway. It is evident that many underlying causes of errors related to the flu vaccine could just as easily lead to mistakes regarding the new COVID-19 vaccines. Therefore, it is crucial for health care providers who administer and/or stock COVID-19 vaccines to learn from these prior errors, anticipate that similar mistakes could happen now, and act to mitigate the risk.

Similar container labels, packaging, and/or vaccine names have contributed to numerous 2020-2021 flu vaccine—related errors. Name confusion is common, because most of the brand names begin with flu and the nonproprietary names include influenza. One example of an error due to name confusion involve the administration of Fluzone Quadrivalent instead of the intended Fluzone High-Dose Quadrivalent to patients older than 65 years. Look-alike labeling and packaging have also contributed to flu vaccine–related errors. For example, practitioners recently reported that for 2 consecutive years, Boostrix (tetanus and reduced diphtheria toxoids, acellular pertussis vaccine adsorbed) has been accidentally administered instead of the intended Fluarix Quadrivalent vaccine. Both vaccines, from GlaxoSmithKline, come in a white box with a green stylized arch along the left border of the front panel. 

Storing vaccines with other unsegregated medications or vaccinations in a freezer or refrigerator has led to mix-ups with serious outcomes. For example, vials of insulin have sometimes been mistaken for flu vaccines,

 and neuromuscular blocking agents have been used to reconstitute vaccines or mistaken for the flu vaccine itself.

 Usually, look-alike labeling and packaging are contributing factors in errors, but not always. Numerous 2020-2021 flu vaccine—related errors were caused by selecting the wrong product from a refrigerator. In one case, a nurse reached into the refrigerator and accidentally removed a prefilled syringe from a carton of what she thought was Fluzone Quadrivalent but was instead Prevnar 13 (pneumococcal 13-valent conjugate vaccine), which she did not know was in the refrigerator. Instead of the flu vaccine, she administered Prevnar 13 to a 5-year-old child.

In several other cases during flu vaccination clinics, practitioners mistakenly removed the wrong age-specific flu vaccine from a cooler and administered it.

Flu vaccines are supplied as a single component, typically as a single dose in a prefilled syringe. However, the high incidence of error reports received by ISMP and others involving 2-component vaccines (eg, vaccine and adjuvant, vaccine liquid and powder components)

 warrants mentioning. This is because the Pfizer-BioNTech COVID-19 vaccine requires a diluent, and subsequent COVID-19 vaccines may include 2 components (eg, adjuvant liquid) in separate vials.

The individual components of 2-component vaccines must be mixed properly, a step that introduces opportunity for errors. Mistakes have occurred when only the adjuvant liquid, diluent, or the undiluted vaccine itself was administered. Unique storage requirements exist for some of the 2-component vaccines, including different temperature ranges for each component. If the 2 components of a COVID-19 vaccine must be stored separately or if the labeling on both components looks similar, the risk of an error is heightened.

NOT USING IMMUNIZATION INFORMATION SYSTEMS OR MEDICAL RECORDS 

Several flu vaccine—related errors led to repeated doses that had already been administered to patients. However, the opposite type of error happens more often with vaccines that require more than 1 dose at specific intervals, much like the mRNA COVID-19 vaccines. Either a patient has received a subsequent dose at the wrong interval or failed to receive a subsequent dose as required. The vaccines most frequently involved in wrong interval errors reported to the ISMP have included those that target diphtheria, tetanus, and/or pertussis; hepatitis A; hepatitis B; and the human papillomavirus.

More than three-fourths of these errors were associated with confusing entries in the immunization information system (IIS), lack of prior vaccine documentation in the IIS or patient’s record, or not checking the IIS or patient’s record.

Many of the underlying causative factors associated with the previously reported vaccine errors could also be factors that lead to errors with the COVID-19 vaccines. Pharmacists should use this information to anticipate these risks as they prepare for COVID-19 vaccination campaigns.

, 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.

Blank C. Pharmacy chains report higher than usual demand for flu vaccines. 

. November 4, 2020. Accessed December 10, 2020. https://www. drugtopics.com/view/pharmacy-chains-report-higher-than-usual-demand-for-flu-vaccines

Masson G. Oklahoma pharmacist accidentally gives 10 people insulin instead of flu shot. Becker’s Hospital Review. November 8, 2019. Accessed December 10, 2020. https://www.beckershospitalreview.com/quality/oklahoma-pharmacist-accidentally-gives-10-people-insulin-instead-of-flu-shot.html

Oberholtz C. Teachers seeking flu shots instead given insulin. KCTV5. October 7, 2014. Accessed December 10, 2020. https://www.kctv5.com/news/teachers-seeking-flu-shots-instead-given-insulin/article_7b445c2a9055-5ddf-ac54-3825b2324483.html

Tragic vaccine diluent mix-ups in Syria have also happened here. Institute for Safe Medication Practices. September 25, 2014. Accessed December 10, 2020. https://www.ismp.org/resources/Tragic-Vaccine-Diluent-Mix-Ups-in-Syria-Have-Also-Happened-Here

Samad F, Burton SJ, Kwan D, et al. Strategies to reduce errors associated with 2-component vaccines. 

. Published online November 5, 2020. doi:10.1007/s40290-020-00362-9

Pharmacists can learn from previous mistakes to prepare for COVID-19 vaccination campaigns.

What Factors Contribute to Influenza Vaccine Errors?

The Institute for Safe Medication Practices (ISMP) recently learned about 3 cases of accidental spinal injection of tranexamic acid instead of a local anesthetic intended for regional (spinal) anesthesia.

Container mix-ups were involved in each case. In 1 case, a patient scheduled for knee surgery received tranexamic acid instead of bupivacaine. The anesthesiologist immediately realized the error, but by then, the patient had begun to experience seizures. The patient recovered. In a second case, a patient undergoing hip replacement surgery received tranexamic acid instead of a local anesthetic for spinal anesthesia. The patient survived but experienced seizures and had extreme pain due to arachnoiditis. In a third case, a patient scheduled for bilateral knee replacement also inadvertently received tranexamic acid instead of bupivacaine for spinal anesthesia. The patient experienced seizures, which necessitated placing her into an induced coma for several days.

The ISMP has previously reviewed errors with tranexamic acid and noted that in the United States, bupivacaine, ropivacaine, and tranexamic acid are packaged in vials that may have the same blue color cap.

 Although label colors and vial sizes may be different, when the vials are stored upright near each other, only the blue caps may be visible, making it more difficult to differentiate 1 drug from another. To make matters worse, these drugs are often found in areas where bar code scanning may not have been implemented or is not routinely used, such as the emergency department, labor and delivery, or perioperative areas, so mix-ups are less likely to be detected. Syringe labeling issues may also contribute to such errors. The literature has additional reports of serious patient harm because of wrong-route errors with tranexamic acid.

Tranexamic acid is an antifibrinolytic that prevents the breakdown of fibrin, thus promoting clotting. It is approved for short-term use (2 to 8 days) in patients with hemophilia to reduce the risk of hemorrhage during and following tooth extraction. It is also used off-label in a variety of hemorrhagic conditions to control bleeding, including postpartum hemorrhage. Although tranexamic acid is not indicated for joint surgeries, it is often used intravenously (IV) or topically during these procedures to decrease blood loss. Tranexamic acid is also available as an oral tablet for the treatment of cyclic heavy menstrual bleeding in women.

When given via the spinal route in error, tranexamic acid is a potent neurotoxin that is harmful to patients, with a mortality rate of about 50%. Survivors often experience permanent neurological injury, paraplegia, seizures, and ventricular fibrillation.

Here are some tips for dealing with tranexamic acid:

Consider NRFit syringes and connectors for local anesthetics used for regional anesthesia administered via the neuraxial route. NRFit connectors are incompatible with Luer connectors, thus preventing misconnections with drugs intended for IV use.

Employ bar code scanning before dispensing and when accessing the drug in obstetrical and surgical areas.

Minimize look-alike caps and vials by purchasing these products from different manufacturers.

Purchase labels marked “Contains Tranexamic Acid” to place over the vial caps.

Separate or sequester tranexamic acid in storage locations and avoid storing local anesthetics and tranexamic acid near each other.

To prevent reliance on identifying the drug by viewing only the vial caps, never store injectable drug vials in an upright position, especially in a bin or drawer below eye level. Store them so that their labels are always visible.

Use commercially available or pharmacy- prepared, premixed containers of tranexamic acid, which would be less likely to be confused with local anesthetic vials. Pharmacy preparation and labeling of infusions or syringes would help alleviate these errors. Also, local anesthetics may be available at some locations in premixed containers or prepared by a pharmacy for use in regional anesthesia.

Dangerous wrong-route errors with tranexamic acid—a major cause for concern. Institute for Safe Medication Practices. May 23, 2019. Accessed November 10, 2020. www.ismp.org/resources/dangerous- wrong-route-errors-tranexamic-acid-majorcause- concern

Veisi F, Salimi B, Mohseni G, Golfam P, Kolyaei A. Accidental intrathecal injection of tranexamic acid in cesarean section: a fatal medication error. APSF Newsletter. 2010. Accessed November 10, 2020. https:// www.apsf.org/article/accidental-intrathecal-injection- of-tranexamic-acid-in-cesarean-section-a-fatal- medication-error

Srivastava U, Joshi K, Gupta V, et al. Accidental injection of tranexamic acid into subarachnoid space leading to fatal outcome: case report and review. 

. 2012. Accessed November 10, 2020. http://ispub.com/IJA/30/2/14109

Yeh HM, Lau HP, Lin PL, Sun WZ, Mok MS. Convulsions and refractory ventricular fibrillation after intrathecal injection of a massive dose of tranexamic acid. Anesthesiology. 2003;98(1):270-272. doi:10.1097/00000542-200301000-00042

Garcha PS, Mohan CVR, Sharma RM. Death after an inadvertent intrathecal injection of tranexamic acid. 

. 2007;104(1):241-242. doi:10.1213/01. ane.0000250436.17786.72

Palanisamy A, Kinsella SM. Spinal tranexamic acid—a new killer in town. 

. 2019;74(7):831-833. doi:10.1111/anae.14632

Alert practitioners to key strategies to reduce the risk of significant harm to patients.

Wrong-Route Errors With Tranexamic Acid Can Be Serious

Searching by generic name for rapid-acting insulins may cause prescribing or dispensing errors.

Medication errors have been reported because of mix-ups between Novo Nordisk’s Fiasp and NovoLog, as well as the company’s authorized generic for NovoLog, all of which are insulin aspart. However, Fiasp has niacinamide in the formulation, which makes it even faster acting than NovoLog. We warned about such errors in the April 2020 issue of 

 Now the same problem exists with Eli Lilly and Company’s newly marketed Lyumjev, Humalog, and the company’s authorized generic for Humalog, all of which are insulin lispro. Lyumjev (pronounced LOOM jehv), which officially is insulin lispro-aabc (a 4-letter suffix is given to newly approved biologicals), contains treprostinil and other ingredients that make the product faster acting than Humalog.

These products have different onsets of action after subcutaneous injection and are not substitutable. Fiasp and Lyumjev are injected at the beginning of a meal or within 20 minutes after beginning to eat.

 Other insulin lispro products, such as Humalog, are given within 15 minutes before a meal or immediately after one.

 Other insulin aspart products, such as NovoLog, are given 5 to 10 minutes before a meal.

Computer listings should always include the brand name for these insulins. For Fiasp, Humalog, Lyumjev, and NovoLog, prescribers should use the appropriate brand name on prescriptions, and electronic prescribing systems should communicate that brand name instead of only including the generic one. A pharmacist who recently reported the potential for mix-ups also recommended including niacinamide in parentheses with Fiasp listings and treprostinil in parentheses for Lyumjev listings. Safety would be improved if the FDA and the manufacturers examined ways to better communicate product differences. Also, patients should be made aware of the differences among insulins and be able to identify that the correct insulin has been dispensed by a pharmacist.

Transdermal fentanyl 75-mcg-per-hour patches were dispensed to a patient with directions to apply 1 patch every 48 hours. However, the physician prescribed fentanyl patches 50 mcg per hour. The prescription read, “fentanyl patch 72-hour 50 mcg/hour transdermal, 1 patch to the skin every 48 hours.”

The pharmacy employee who entered the prescription into the pharmacy computer system read “fentanyl patch 72,” which led him to mistakenly select a 75-mcg-per-hour patch instead of a 50-mcg-per-hour patch. The inclusion of the duration of controlled drug delivery, such as 72 hours, in the drug description field contributed to this dispensing error.

To reduce this type of error, the duration of controlled drug delivery should not be included within the product description, which should include the release rate per hour, in this case, 50 mcg/hour. The dosing instructions should communicate the frequency of changing the patch, in this case, every 48 hours.

An oncology clinic reported an unintended consequence of telehealth visits: the inability to document an accurate weight, leading to incorrect dosages of weight-based drugs. In this case, the patient had come into the clinic for her first chemotherapy treatment: protein-bound paclitaxel and gemcitabine. Because of coronavirus disease 2019, the patient had been participating in telehealth visits for several months prior to her first chemo treatment, during which her weight had not been measured or updated for 4 months. When she arrived at the oncology clinic for her first dose of chemo, her weight was obtained.

Unfortunately, the chemo plan was based on the weight measured 4 months prior, and the patient had lost weight. While double checking the chemo dose, the nurse noticed that the patient’s body surface area (BSA) was 7% lower than the BSA listed on her chemo treatment plan. In this organization, a BSA difference of 5% or greater requires a change in the dose. However, it took more than 2 hours to authorize a new dose based on the patient’s BSA, delaying the beginning of chemo administration. The clinic is working on a process to flag weights in the electronic health record that require updating prior to prescribing, dispensing, and/or administering weight-based medications. The clinic employees also are now inquiring about weight gain or loss during all telehealth encounters.

, 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.

Gaunt MJ. High-alert medications require special safeguards. Pharmacy Times®. April 28, 2020. Accessed October 5, 2020. www.pharmacytimes.com/publications/issue/2020/april2020/high-alert-medications-require-special-safeguards

Fiasp. Prescribing information. Novo Nordisk Inc; 2000. Accessed November 13, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208751s000lbl.pdf

Lyumjev. Prescribing information. Eli Lilly and Company; 2020. Accessed October 5, 2020. https://pi.lilly.com/us/lyumjev-uspi.pdf?s=pi

Humalog.Prescribing information. Eli Lilly and Company; 1996. Accessed November 13, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020563s115lbl.pdf

Novolog.Prescribing information. Novo Nordisk Inc; 2019. Accessed October 5, 2020.www.novo-pi.com/novolog.pdf

Reduce the risk of errors with rapid acting–insulins fentanyl patches and weight-based chemotherapy doses.