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Advantages and Disadvantages of Janssen’s COVID-19 Vaccine Candidate

Moderna COVID Vaccine Effective at 90 Days

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When Disaster Strikes, Hospitals Call in Residents

Alarming Increase Seen in Muscle Relaxant Use as Treatment for Chronic Pain

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EDITORIAL BOARD

ADMINISTRATION

Robert Adamson, PharmD, Livingston, NJ James A. Jorgenson, MS, RPh, St. Paul, MN Indu Lew, PharmD, Livingston, NJ

AMBULATORY CARE

Meghan D. Swarthout, PharmD, MBA, BCPS, Sallston, MD

ANESTHESIOLOGY/PAIN

Julie A. Golembiewski, PharmD, Chicago, IL David S. Craig, PharmD, BCPS, Tampa, FL Robert L. Barkin, MBA, PharmD, Chicago, IL

CARDIOLOGY

C. Michael White, PharmD, Storrs, CT

CNS/PSYCHIATRY

Lawrence Cohen, PharmD, FASHP, FCCP, Fort Worth, TX

COMPLEMENTARY AND ALTERNATIVE MEDICINE

Cathy Rosenbaum, PharmD, Cincinnati, OH

CRITICAL CARE

Judi Jacobi, PharmD, FCCM, Indianapolis, IN

INFECTIOUS DISEASES

Steven J. Martin, PharmD, BCPS, FCCM, Toledo, OH David P. Nicolau, PharmD, Hartford, CT Jason Pogue, PharmD, Detroit, MI

LEADERSHIP

ErnestR. Anderson Jr., MS, RPh, Boston, MA Elaine Strauss, PharmD, MS, Atlanta, GA

NUCLEAR PHARMACY

Jeffrey Norenberg, PharmD, Albuquerque, NM Volume 48 • Number 4 • April 2021 • pharmacypracticenews.com

NUTRITION

Beverly Holcombe, PharmD, BCNSP, FASHP, FASPEN Chapel Hill, NC Vanessa Kumpf, PharmD, BCNSP, Nashville, TN

ONCOLOGY

Cindy O’Bryant, PharmD, Aurora, CO Lisa Holle, PharmD, Farmington, CT Ali McBride, PharmD, MS, BCPS, Phoenix, AZ Sara S. Kim, PharmD, BCOP, New York, NY

ORGAN TRANSPLANT PHARMACY

Eric Tichy, PharmD, BCPS, New Haven, CT

PEDIATRICS

Gretchen Brummel, PharmD, BCPS, Hudson, OH

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Kristin Jannacone, Copy Editor

PHARMACOGENOMICS

Henry “Mark” Dunnenberger, PharmD, Evanston, IL

REIMBURSEMENT

Bonnie E. Kirschenbaum, MS, FASHP, Breckenridge, CO

SPECIALTY PHARMACY

JoAnn Stubbings, BSPharm, MHCA, Chicago, IL

STERILE COMPOUNDING

Kristina N. Bryowsky, PharmD, MBA, BCPS, Fenton, MO

TECHNOLOGY

Thomas Van Hassel, RPh, Yuma, AZ

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ISMP Top 10 Hazards

continued from page 1

recommendations can be found in the full document (bit.ly/3k2IKsD).

Extended-Release (ER)

Opioids

ISMP received three reports in 2020 of inappropriate prescribing of fentaNYL patches to elderly opioid-naive patients, sometimes to treat acute pain rather than chronic pain (ISMP Medication Safety Alert! July 2, 2020; bit.ly/2ZFY0Cs). The patients were documented as having “allergic reactions” to other analgesics, but further investigation by pharmacists or other providers revealed they were only mild intolerances that did not

justify prescribing of these medications. The errors were detected before patients suffered any serious harm, according to ISMP.

“Inappropriate prescribing of these drugs often happens because [clinicians] are not aware of the dangers of this practice, or they don’t understand what constitutes the difference between ‘opioidnaive’ and ‘opioid-tolerant,’” said Mike Cohen, RPh, the president of ISMP.

ISMP Recommendation: Prohibit prescribing of fentaNYL patches to opioid-naive patients and those with acute pain. This requires establishing definitions for opioid naivete and opioid tolerance, and creating a standard process for gathering and documenting opioid status and type of pain. Setting computerized order entry system defaults for extendedrelease opioids to the lowest starting dose and frequency, and creating electronic alerts to confirm opioid use history when prescribing and dispensing these agents also can help prevent inappropriate prescribing.

Not Using Smart

Infusion Pumps With Dose Error Software

Despite the increasing use of smart pumps with dose error reduction systems (DERS), the safety feature has been adopted less widely by anesthesia providers in perioperative settings, ISMP noted (bit.ly/3aKffc9). In one case reported to the organization in 2020, a provider selected dexmedetomidine from the smart pump drug library, erroneously entering “Min” for minutes, delivering an infusion of the drug at a rate of 0.15 mcg/kg per minute, instead of 0.15 mcg/kg per hour. Since the DERS feature was not engaged, the pump did not issue a dose error warning and the infusion continued for several hours before it was detected, and patient harm was averted.

ISMP noted that anesthesia providers may not know these capabilities can be applied to loading and bolus doses, which are commonly administered in these settings. That knowledge gap may explain why DERS sometimes are not used in the perioperative setting. “Also, many organizations use smart pumps in the operating room in anesthesia mode, in which case hard stops are often reduced to soft stops and providers can easily override limits that should never be bypassed,” Cohen said.

ISMP Recommendation: Include anesthesia providers when building a smart pump library. When possible, they should use upper and lower hard limits and employ the bolus feature with hard limits to avoid catastrophic doses being administered. Bolus doses should not be delivered by simply increasing infusion rate.

“We also encourage organizations to analyze their smart pump data to better understand why DERS are not being used in the perioperative setting,” Cohen added.

Errors With Oxytocin

Providing a bolus of oxytocin too rapidly can overstimulate the uterus, potentially causing fetal distress or uterine rupture, and leading to emergency cesarean delivery (ISMP Canada Safety Bulletin 2019;19[8]:1-5; bit.ly/3dF03ia). “This can happen, for example, when flushing IV lines with retained drug,” Cohen said.

A separate joint report by ISMP and ISMP Canada found that oxytocin-related errors have been caused by look-alike mix-ups, with generic oxytocin and brand PITOCIN vials both using the same green caps as a number of ondansetron vials (bit.ly/2NvEnu7). Several prescribing errors also have occurred due to the selection of similarly named drugs on electronic order entry screens. For example, a search for “OXY10” can bring up oxycodone, while searches for “PIT” can yield a result for PITRESSIN. Other errors reported to ISMP were caused by verbal orders being misheard.

In other cases, oxytocin infusions prepared outside the pharmacy and inadequately labeled led to administration errors, with doses up to 10 times higher than intended being administered, or infusion bags being swapped.

ISMP Recommendation: Require prescribers to use at least five letters from a drug’s name when searching an electronic order entry system. Additionally, oxytocin should be mixed only in the pharmacy and dispensed in readyto-administer, clearly labeled bags in standardized concentrations. Once an oxytocin infusion is completed, the IV line should be changed or tubing should be flushed after it is disconnected.

Preparation and Storage Challenges

Product preparation and/or labeling problems

Lack of appropriate safe storage measures

IV AdministrationAssociated Errors

Errors in infusion pump connections or IV line setup

Infusion rate confusion

Communication and Documentation Gaps

Absence of, or deviation from, protocol

Incomplete handoffs at transitions of care

Figure. Main themes identified from oxytocin-associated medication incidents.

Source: ISMP Canada; bit.ly/3dF03ia.

Infusion Pump Hazards

Many hospitals have reported positioning infusion pumps outside of COVID-19 patients’ rooms to conserve personal protective equipment (PPE), limit staff exposure to patients with COVID-19, and ensure pump alarms are heard and responded to promptly (bit.ly/3brCw1z). ISMP noted that this practice requires long extension sets, which often have a smaller diameter than typical tubing.

“This means more fluid is needed to prime the tube, and flow rates might be affected,” Cohen said.

At low flow rates, occlusion alarms might sound due to delays in the time it takes for a medication to reach the patient, or an occlusion alarm might sound at high flow rates, ISMP noted.

Other risks associated with this practice include personnel tripping over extension tubing and electrical cords, and difficulty performing double checks and barcode scanning when the pump is outside the room.

“Because nurses cannot scan the barcode on a patient’s identification band, some hospitals affix the patient’s name, birthdate and a barcode to the pump or IV pole outside the room,” Cohen said, cautioning there is a risk for transferring these IV poles to other patients without removing the labels.

ISMP Recommendation: Follow guidelines issued by ECRI (bit.ly/ 37CZPnY). ECRI suggests conducting periodic infusion pump rounds in the hallway to verify pump settings, and developing temporary processes that include

some elements of barcode scanning or independent double checks prior to medication administration, as Pharmacy Practice News previously reported (bit.ly/ 3os0K1s-PPN).

ISMP recommended not continuing to situate infusion pumps in hallways once the pandemic has abated.

Errors With COVID-19 Vaccines

A number of errors involving COVID-19 vaccines reported to ISMP are included in the 2020 medication errors list (bit.ly/ 3umgwhd). The errors included several reported allergic reactions, dilution errors with the Pfizer/BioNTech vaccine, and vaccines being given to patients outside the current eligibility groups.

ISMP also cautioned against administration errors, citing one incident involving the Moderna COVID-19 vaccine. Instead of receiving the first dose of the vaccine, 44 adults at a West Virginia clinic received IM injections of

casirivimab, one of two new Regeneron monoclonal antibodies recently granted emergency use authorization in the United States to treat adults and children with mild to moderate COVID-19 who are at risk for progressing to severe COVID-19 and/or hospitalization. No serious adverse reactions were reported, and patients were offered the vaccine as soon as possible.

Although ISMP said it did not have a detailed description of why the error happened, “product packaging and labeling issues were likely involved,” the safety group stated in an earlier, more detailed report on the error (bit.ly/ 3umgwhd). ISMP noted that the Moderna vaccine vial has a red cap, similar to the red cap on vials of Regeneron’s monoclonal antibodies, possibly leading to the administration mixup. Further adding to the confusion, both monoclonal antibodies were shipped in cartons that did not include the name of the specific antibody contained within and instead listed a product code number for casirivimab (REGN10933) and imdevimab (REGN10987). Although the vial label contains a barcode, at the time of the errors, the bar code was not functional or associated with a National Drug Code (NDC) number, according to ISMP.

ISMP Recommendation: To limit administration errors, ISMP suggested drawing on cautions it already has issued in response to flu vaccine errors, such as keeping an eye out for lookalike vaccine names and labels and avoiding the unsegregated storage of vaccines and other vials. As for more general errors involving COVID-19 vaccines, ISMP suggested ensuring there is enough space at the site to evaluate patients after an injection for possible allergies and to treat them in case of a reaction, while still following social distancing guidelines and other pandemic measures. ISMP also recommended verifying that vaccinators have competencies in storing, preparing and administering vaccines; assessing patients; identifying the proper vaccine injection site; and providing emergency treatment in case of anaphylaxis.

‘Syringe Pull-back’

Method Still In Use—and Still Deadly

As ISMP previously reported, syringe pull-back verification is associated with an error rate as high as 9% (Am J Hosp Pharm 1997;54:904-912). Failure to detect wrong concentrations, wrong strengths and wrong products or diluents can cause fatal errors, ISMP noted. Using the pull-back method, an ingredient is injected from the syringe into the final container, and then the plunger is pulled back to the amount on the syringe that was injected. It is this “pulled-back” syringe that is checked to determine the accuracy of the amount injected. Errors may not be detected if the syringe does not reflect the actual amount added or if the syringe is not partnered with the correct container, ISMP noted.

ISMP Recommendation: Eliminate use of this method. Instead, have other staff verify the proper ingredients and volumes before they are added to the final container, as ISMP reported in its 2020 “Targeted Medication Safety Best Practices for Hospitals” (bit.ly/3pJa1kX). ISMP also recommended that organizations implement barcode scanning, gravimetric verification, robotics and IV workflow software in the compounding process. But it added a caveat: “When technology is in use, it is important that processes are in place to ensure it is maintained, the software is updated, and that the technology is always used in a manner that maximizes the medication safety features of these systems.”

see TOP 10 HAZARDS, page 6

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TOP 10 HAZARDS

continued from page 5

Dangerous Admixtures Outside of the Pharmacy

A 2020 ISMP survey of 444 nonpharmacist hospital practitioners found that 28% of respondents said they often or always admixed a variety of IV infusion types outside the pharmacy (bit.ly/ 3qL5RdQ). “This is an error-prone practice that happens often during emergency situations, but is sometimes done routinely,” Cohen said. Most survey respondents were nurses (77%, including advanced practice nurses) and anesthesia providers (8% certified registered nurse anesthetists and anesthesiologists). The remaining respondents (15%) included decentralized pharmacists or technicians who prepare admix medications and/or infusions in clinical areas, as well as physicians, supervisors and others.

Nearly half the survey respondents said they had no formal training in admixture, and many said they had to rush preparations, could not label the product appropriately, did the mixing by memory, were interrupted or distracted, and were concerned about the sterility and accuracy of the final product. Roughly one-third said they were aware of errors associated with their outside-of-pharmacy compounding.

ISMP Recommendation: Institutions should conduct their own survey and use the results to hold discussions about this unsafe practice and find ways to increase the use of ready-to-use products prepared by the pharmacy or manufacturers. ISMP included survey questions in the August 2020 ISMP Nurse AdviseERR newsletter (bit.ly/3dCMtMc).

WORKING THROUGH IT, TOGETHER

to help address your patients’ needs

Pfi zer Hospital remains committed to delivering the medications that are needed when it matters most— now and into the future.

Helped meet the acute needs of customers during times of crisis.

Invested in identifying and supplying critical products. Remains committed to achieving a sustainable marketplace.

Medication Loss

When Administering Small-Volume Infusions

Patients can be significantly underdosed when small-volume (50-100 mL) intermittent infusions are given through longer primary administration sets that are connected to a vascular access device, ISMP noted.

“Residual medication may be left in the tubing and this could, of course, have a clinical impact on a patient’s outcomes,” Cohen said.

An ISMP analysis of data from one health system found roughly 360,000 small-volume infusions that were likely administered to patients at significantly lower doses than prescribed due to using a primary administration set (bit.ly/ 3aJcU0R). Based on ISMP’s observations in other organizations and the literature, “the scope of this problem is much larger than only within this health system,” the report noted.

Although flushing the tubing of the intermittent infusion can help ensure the full dose is given, the flush volume needs to be as large as the residual volume left in the primary administration set, and that amount may not always be administered, ISMP added.

ISMP Recommendation: Administer intermittent infusions using a shorter secondary set and embed an appropriate carrier fluid in order sets for smallvolume infusions. The tubing should be flushed with the carrier fluid after the medication has been administered to ensure the full dose has been delivered.

In the case of the health-system cited in the report, several additional steps were taken to reduce the opportunity for small-volume infusion errors: • Health system–engaged nurse educators created an educational docu-

ment on the topic and came up with a catchy slogan: If the bag is the small kind, put it on a secondary line. • They also created a pop-up warning on automated dispensing cabinet screens to administer small-volume intermittent infusions with a secondary set. • The pharmacy also affixed labels to minibags stating, “Infuse via secondary set” for the first few months of the educational program.

Wrong-Route Errors With Tranexamic Acid

ISMP received a number of reports of intraspinal tranexamic acid injections administered instead of intraspinal injections of local anesthetic for epidural or spinal anesthesia, and the mistake has led to seizures (bit.ly/ 3dCRG6I). These errors often are due to mix-ups between bupivacaine, ropivacaine and tranexamic acid, which are packaged in vials with the same blue cap, ISMP noted.

“Particularly when the vials are stored upright, practitioners can pick up a vial based on cap color and not notice it is the wrong vial,” Cohen said.

ISMP Recommendation: Purchase bupivacaine, ropivacaine and tranexamic acid with different colored caps from separate manufacturers, or premix bags and prepare syringes or infusions in the

pharmacy only. It is also recommended to avoid upright storage of the vials to ensure labels are visible, and to store tranexamic acid vials away from other look-alike vials.

Use of Error-Prone

Abbreviations, Symbols or Dose Designations

Given the potential risks related to misunderstanding of abbreviations, symbols and dose designations (Jt Comm J Qual Patient Saf 2007;33[9]:576-583), ISMP continues to emphasize safe use of these practices. “These may be convenient and save time, and using them is one way of fitting a word, phrase or dose into a restricted space, but they can be misunderstood, misread or misinterpreted, and cause patient harm,” Cohen said, adding that they should NEVER be used when communicating medical information verbally, electronically, and/or in handwritten applications.

ISMP Recommendation: Review ISMP’s most recent list of error-prone abbreviations, symbols and dose expressions, and avoid their use. The list was recently updated for 2021 and can be accessed at bit.ly/3cKVot0. “We encourage organizations to review our updated list and to use it to create or update your organization’s ‘Do Not Use’ abbreviation list,” ISMP stated. “Error-prone abbreviations, symbols, and dose designations that are included on the Joint Commission’s ‘Do Not Use’ list (Information Management standard IM.02.02.01) are highlighted in the ISMP list, as are the error-prone abbreviations, symbols and dose designations that are relevant mostly in handwritten communications.”

—David Wild, David Bronstein

The sources reported no relevant fi nancial disclosures.

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