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What’s New in the Patient Safety World

February 2021

· ISMP: 2 Alerts on NMBA’s

· Top 10 Lists

· Risk from Intrahospital Transfer: Healthcare-Associated Infection

· Under the Radar: Muscle Relaxant Use

ISMP: 2 Alerts on NMBA’s

Fatal errors due to inadvertent administration of neuromuscular blocking agents (NMBA’s) have been problematic. There have been numerous interventions intended to prevent them and no single one is likely to ensure success. But each individual intervention contributes to the defenses.

“Look-alike” vials have been one factor contributing to such errors. So, one important intervention has been labeling of vials containing NMBA’s. Form several years, warnings on the vial caps stating “Paralyzing Agent” have been required. However, ISMP (Institute for Safe Medication Practices) has just published a warning that vials of NMBA’s lacking this warning have again appeared (ISMP 2021a). ISMP notes that, due to drug shortages during the COVID-19 pandemic, the FDA has allowed temporary manufacturing of these drugs without the vial cap (seal) warning statement. The ISMP article names specific products affected.

One important point in the ISMP alert is that the expiration date on several of the products affected is in mid-2022. That means that, even if the shortages are resolved, some of these vials are likely to be in hospital stock for over another year.

Therefore, it is critical that nurses and pharmacists and any others who handle or administer these drugs be made aware of this danger. ISMP recommends having pharmacy affix auxiliary “Warning: Paralyzing Agent” labels to vial caps prior to storage in critical care units, the perioperative setting, and emergency departments.

In our multiple prior columns on NMBA incidents (see full list below), we have also discussed other important interventions to prevent such accidents. Appropriate segregation of NMBA vials from other drugs, especially “look-alike” vials, is critical. NMBA vials should also not be part of “floor stock”. When NMBA’s are included in automated dispensing cabinets (ADC’s), you should require acknowledgement that the patient is mechanically ventilated (or the NMBA is to be used during intubation) before allowing retrieval of the vial from the ADC.

We’d also recommend that, as the drug shortage is resolved and new vials having the appropriate warning on the caps arrive, you remove any of the unlabeled vials from stock.

It’s important you heed this ISMP warning. You don’t want to put your patients in jeopardy. And you don’t want to put any of your staff in jeopardy of being at the sharp end of a tragic error cascade.

But, shortly after that first warning, ISMP issued another alert requiring immediate attention (ISMP 2021b): an extremely hazardous packaging error involving certain cisatracurium products from Meitheal Pharmaceuticals. While the outer carton identifies the vials inside as cisatracurium, the vials contained in the carton are labeled phenylephrine injection. The vials actually contain cisatracurium and have caps appropriate for a paralyzing agent. But, if you don’t notice this cap warning, you may think you are injecting phenylephrine. Results in a non-intubated, non-ventilated patient would be disastrous. ISMP urges facilities to immediately examine any and all cartons of cisatracurium from Meitheal Pharmaceuticals for this serious packaging error and make sure that none of these vials were actually distributed. ISMP has confirmed that both the FDA and the manufacturer are aware of this situation and that a recall is imminent. 

Some of our prior columns on neuromuscular blocking agents (NMBA’s):

June 19, 2007 “Unintended Consequences of Technological Solutions”

July 31, 2007 “Dangers of Neuromuscular Blocking Agents”

November 2007 “FMEA Related to Neuromuscular Blocking Agents”

May 20, 2008 “CPOE Unintended Consequences - Are Wrong Patient Errors More Common?”

January 31, 2012 “Medication Safety in the OR”

February 7, 2012 “Another Neuromuscular Blocking Agent Incident”

October 22, 2013 “How Safe Is Your Radiology Suite?”

December 9, 2014 “More Trouble with NMBA’s”

December 11, 2018 “Another NMBA Accident”

January 1, 2019 “More on Automated Dispensing Cabinet (ADC) Safety”

February 12, 2019 “From Tragedy to Travesty of Justice”

April 2019 “ISMP on Designing Effective Warnings”

References:

ISMP (Institute for Safe Medication Practices). Paralyzing agent vial caps without warnings into 2022. NurseAdvisERR® 2021; 19(1): 3-4 January 2021

https://www.ismp.org/nursing/medication-safety-alert-january-2021

ISMP (Institute for Safe Medication Practices). Hazardous Packaging Error. ISMP Alert 2021; January 26, 2021

https://www.ismp.org/alerts/hazardous-packaging-error

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Top 10 Lists

This time of year is when all the “Top 10” lists on patient safety issues come out. Three big ones have come out from ISMP (Institute for Safe Medication Practices), ECRI Institute, and Becker’s Hospital Review.

ISMP’s “Start the Year Off Right by Preventing These Top 10 Medication Errors and Hazards from 2020” (ISMP 2021) has its list Top 10 Medication Errors and Hazards from 2020:

1. Prescribing, dispensing, and administering extended-release (ER) opioids to opioid-naïve patients
2. Not using smart infusion pumps with dose error-reduction systems (DERS) in perioperative settings
3. Errors with oxytocin
4. Hazards associated with positioning infusion pumps outside of COVID-19 patients’ rooms
5. Errors with the COVID-19 vaccines
6. Use of the retrospective, proxy “syringe pull-back” method of verification during pharmacy sterile compounding
7. Combining or manipulating commercially available sterile products outside the pharmacy
8. Medication loss in the tubing when administering small-volume infusions via a primary administration set
9. Wrong route (intraspinal injection) errors with tranexamic acid
10. Use of error-prone abbreviations, symbols, or dose designations

ECRI Institute’s “Top 10 Health Technology Hazards for 2021” (ECRI 2021)

(ECRI 2021):

1. Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization
2. Fatal Medication Errors Can Result When Drug Entry Fields Populate after Only a Few Letters
3. Rapid Adoption of Telehealth Technologies Can Leave Patients and Data at Risk
4. Imported N95-Style Masks May Fail to Protect Healthcare Workers from Infectious Respiratory Diseases
5. Relying on Consumer-Grade Products Can Lead to Inappropriate Healthcare Decisions
6. Hasty Deployment of UV Disinfection Devices Can Reduce Effectiveness and Increase Exposure Risks
7. Vulnerabilities in Third-Party Software Components Present Cybersecurity Challenges
8. Artificial Intelligence Applications for Diagnostic Imaging May Misrepresent Certain Patient Populations
9. Remote Operation of Medical Devices Designed for Bedside Use Introduces Insidious Risks
10. Insufficient Quality Assurance of 3D-Printed Patient-Specific Medical Devices May Harm Patients

Becker’s 10 top patient safety issues for 2021 (Carbajal 2021):

1. COVID-19
2. Healthcare staffing shortages
3. Missed and delayed diagnoses
4. Drug and medical supply shortages
5. Low vaccination coverage and disease resurgence
6. Clinician burnout
7. Health equity
8. Healthcare-associated infections
9. Surgical mistakes
10. Standardizing safety efforts

Even though the themes of these lists are slightly different for each organization, you can see there is still considerable overlap and issues related to COVID-19, directly or indirectly, dominate the lists. We refer you to the original articles for details of each item on the respective lists.

References:

ISMP (Institute for Safe Medication Practices). Start the Year Off Right by Preventing These Top 10 Medication Errors and Hazards from 2020. ISMP Medication Safety Alert! Acute Care Edition 2011; 26(2): January 27, 2021

https://www.ismp.org/resources/start-year-right-preventing-these-top-10-medication-errors-and-hazards-2020

ECRI Institute. Top 10 Health Technology Hazards for 2021. ECRI Institute 2021; January 2021

https://www.ecri.org/2021-top-10-health-technology-hazards-executive-brief/

Carbajal E, Masson G, Bean M. Becker’s 10 top patient safety issues for 2021; Becker’s Hospital Review 2021; December 30th, 2020

https://www.beckershospitalreview.com/patient-safety-outcomes/10-top-patient-safety-issues-for-2021.html

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Risk from Intrahospital Transfer: Healthcare-Associated Infection

We’ve done many columns on the dangers of intrahospital transports and the need to do careful planning to avoid those dangers. But we’ve focused primarily on temporary transports to areas such as radiology or the OR. But there is a different sort of intrahospital transfer that is also problematic – the transfer of patients from beds on one unit to beds on another unit.

A recent study from the UK (Boncea 2021) found that intrahospital transfers are associated with increased odds of developing a healthcare-associated infection (HAI). The authors suggest that strategies for minimizing intrahospital transfers should be considered, and further research is needed to identify unnecessary transfers. Their reduction may diminish spread of contagious pathogens in the hospital environment.

The frequency of such intrahospital transfers should probably not surprise you. Only 27.8% of patients did not undergo any intrahospital transfers. 44.2% of patients underwent one intrahospital transfer, 17.1% underwent two transfers, and 11.0% underwent three or more transfers. Overall, 11.9% of patients developed an HAI. C. difficile infection accounted for almost a third of the HAI’s, but many other pathogens were implicated as well.

The multivariable logistic regression modelling showed that each additional intrahospital transfer was associated with a 9% increase in the odds of developing an HAI (OR=1.09).

The accompanying editorial (Escobar 2021) notes that cases and controls were well matched, and the statistical modelling provided very compelling results. But it notes the study did not adjust for the indication for transfer (eg, transfer to or from the intensive care unit based on patient acuity, transfer for isolation precautions or transfer due to bed capacity or staffing issues) to determine if the patient care needs, isolation status or hospital strain modify the observed risk. It therefore recommends, as do Boncea et al., that prospective studies are needed to better identify the clinical, administrative and systems factors that contribute to more frequent intrahospital transfers.

Boncea et al. note several factors that could underlie a possible association between HAIs and intrahospital transfers:

• Patients with frequent transfers are exposed to a greater number of environments and contacts in the hospital, increasing their risk of exposure to pathogens from contaminated surfaces, other patients or healthcare workers.
• Transferred patients may also experience delays in receiving care on admission to a new unit, thus extending their hospital stay, which is itself a risk factor for HAIs.
• Extended interactions with hospital staff are known to promote infection spread. They cite that 1.7 nurses are required for conducting a transfer, and 1.9 nurses for receiving one.

Especially in the COVID-19 era, where hospital bed shortages are rampant, we often move patients from one site to another, The Boncea study suggests we not simply act reflexly in such intrahospital transfers, but rather carefully consider the implications before carrying out such transfers. The 9% increased risk of an HAI associated with each transfer is a substantial consideration. There are, of course, other unwanted consequences of intrahospital transfers. For example, one study (Goldberg 2015) found that room transfers amongst hospitalized elderly medical patients substantially increased the risk of development of delirium (OR 9.69).

But one has to weigh the benefits of transfer against the risks. There are risks of keeping a patient on a unit not used to caring for such patients. We cohort patients on floors with special expertise in care for patients with certain conditions. A patient being followed by one service (eg. neurology) who is temporarily housed on a non-neurology floor gets less attention from the neurology staff than he would were he housed on the neurology floor. In addition, the nursing care on the specialty unit is much more attuned to the problems that neurology patient is likely to have. So, decisions about transferring patients from one location in the hospital to another can’t simply be based on the risk of HAI. Nevertheless, the substantial risk of HAI pointed out in the Boncea study should make us recognize that decisions about transfer of patients should not be made rashly.

Some of our prior columns on intrahospital transports and the “Ticket to Ride” concept:

• April 8, 2008 “Oxygen as a Medication”
• November 18, 2008 “Ticket to Ride: Checklist, Form, or Decision Scorecard?”
• August 11, 2009 “The Radiology Suite…Again!”
• March 13, 2012 “Medical Emergency Team Calls to Radiology”
• August 25, 2015 “Checklist for Intrahospital Transport”
• September 1, 2015 “Smarter Checklists”
• November 2016 “Oxygen Tank Monitoring”
• February 2018 “Oxygen Cylinders Back in the News”
• May 22, 2018 “Hazardous Intrahospital Transport”
• October 30, 2018 “Interhospital Transfers”
• March 31, 2020 “Intrahospital Transport Issues in Children”
• June 23, 2020 “Telemetry Incidents”
• July 14, 2020 “A Thesis on Intrahospital Transports”
• August 4, 2020 “Intravenous Issues”

References:

Boncea E, Expert P, Honeyford K. Association between intrahospital transfer and hospital-acquired infection in the elderly: a retrospective case-control study in one urban UK Hospital network. BMJ Qual Saf 2021; Published Online First: 25 January 2021

https://qualitysafety.bmj.com/content/early/2021/01/24/bmjqs-2020-012124

Escobar D, Pegues D. Healthcare-associated infections: where we came from and where we are headed. BMJ Quality & Safety 2021; Published Online First: 08 January 2021

https://qualitysafety.bmj.com/content/early/2021/01/08/bmjqs-2020-012582

Goldberg A, Straus SE, Hamid JS, Wong CL. Room transfers and the risk of delirium incidence amongst hospitalized elderly medical patients: a case-control study. BMC Geriatr 2015; 15: 69. Published 2015 Jun 25

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4478641/pdf/12877_2015_Article_70.pdf

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Under the Radar: Muscle Relaxant Use

We’ve done many columns on potentially inappropriate medications (PIM’s) in older adults (see list below). We’ve often focused on drugs with prominent anticholinergic actions, sedative/hypnotic drugs, benzodiazepines, gabapentinoids, and others. But there is one class of PIM’s that has largely flown “under the radar”: skeletal muscle relaxants. And there has been a disturbing trend in prescribing patterns for drugs in this class.

The 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults (AGS 2019) notes that most muscle relaxants are poorly tolerated by older adults because some have anticholinergic adverse effects, sedation, increased risk of fractures; and their effectiveness at dosages tolerated by older adults questionable. Examples of skeletal muscle relaxants they note are: Carisoprodol, Chlorzoxazone, Cyclobenzaprine, Metaxalone, Methocarbamol, and Orphenadrine.

A recent analysis (Soprano 2020) found that skeletal muscle relaxant (SMR) use increased rapidly between 2005 and 2016. During the study period, office visits with a prescribed SMR nearly doubled. Actually, visits for new SMR prescriptions remained stable, but office visits with continued SMR drug therapy tripled. Older adults accounted for 22.2% of visits with an SMR prescription. Concomitant use of an opioid was recorded in 67.2% of all visits with a continuing SMR prescription.

So, what’s driving this trend? SMR’s have been increasingly used in long-term pain management, despite lack of data on efficacy and safety. It’s likely that the opioid epidemic and the resultant push to reduce opioid prescribing has made clinicians look for alternatives to opioids in management of chronic pain.

The major indication for SMR use is for acute low back pain. There is little evidence of SMR efficacy in managing chronic low back pain. And the use of SMR’s for all other types of chronic pain is “off-label” and based largely on anecdotal data.

That SMR use was associated with concomitant opioid use in 67% of visits is particularly bothersome. One study identified an elevated risk of overdose with concomitant use of opioids and skeletal muscle relaxants (Li 2020).

We, personally, have never been fans of skeletal muscle relaxants, even for acute low back pain. So, we were quite taken aback to see this disturbing trend in SMR prescribing. This is probably a situation in which use of clinical decision support tools in ePrescribing applications or CPOE might be useful. Clinical decision support tools could alert clinicians about dangers prescribing them to older adults, suggest long-term use of SMR’s is not appropriate, and to particularly flag issues with concomitant use of opioids.

Some of our past columns on Beers’ List and Inappropriate Prescribing in the Elderly:

• January 15, 2008 “Managing Dangerous Medications in the Elderly
• June 2008 “Potentially Inappropriate Medication Use in Elderly Hospitalized Patients”
• October 19, 2010 “Optimizing Medications in the Elderly”
• September 22, 2009 “Psychotropic Drugs and Falls in the SNF”
• September 2010 “Beers List and CPOE”
• June 21, 2011 “STOPP Using Beers’ List?”
• December 2011 “Beers’ Criteria Update in the Works”
• May 7, 2013 “Drug Errors in the Home”
• November 12, 2013 “More on Inappropriate Meds in the Elderly”
• January 28, 2014 “Is Polypharmacy Always Bad?”
• March 4, 2014 “Evidence-Based Prescribing and Deprescribing in the Elderly”
• September 30, 2014 “More on Deprescribing”
• February 10, 2015 “The Anticholinergic Burden and Dementia”
• May 2015 “Hospitalization: Missed Opportunity to Deprescribe”
• July 2015 “Tools for Deprescribing”
• November 2015 “Medications Most Likely to Harm the Elderly Are…”
• August 2, 2016 “Drugs in the Elderly: The Goldilocks Story”
• October 31, 2017 “Target Drugs for Deprescribing”
• January 2018 “What Happens After Delirium?”
• May 2018 “Antipsychotic Use in Nursing Homes: Progress or Not?”
• June 2018 “Deprescribing Benzodiazepine Receptor Agonists”
• October 2018 “STOPP/START/STRIP”
• November 27, 2018 “Focus on Deprescribing”
• March 19, 2019 “Updated Beers Criteria”
• March 10, 2020 “Medication Harm in the Elderly”
• June 2020 “The Antipsychotics in Dementia Conundrum”

References:

2019 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults. J Amer Geriatr Soc 2019; First published: 29 January 2019

https://onlinelibrary.wiley.com/doi/abs/10.1111/jgs.15767

Soprano SE, Hennessy S, Bilker WB, Leonard CE. Assessment of Physician Prescribing of Muscle Relaxants in the United States, 2005-2016. JAMA Netw Open 2020; 3(6): e207664

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2767591

Li Y, Delcher C, Wei YJ, et al. Risk of opioid overdose associated with concomitant use of opioids and skeletal muscle relaxants: a population-based cohort study. Clin Pharmacol Ther 2020; Published online February 5, 2020

https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.1807

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Print “February 2021 What's New in the Patient Safety World (full column)”

Print “February 2021 ISMP: 2 Alerts on NMBA’s”

Print “February 2021 Top 10 Lists”

Print “February 2021 Risk from Intrahospital Transfer: Healthcare-Associated Infection”

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