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Patient Safety Tip of the Week   

August 11, 2020 

Above-Door Alarms to Prevent Suicides

In our September 3, 2019 Patient Safety Tip of the Week “Lessons from an Inpatient Suicide” we discussed an unfortunate suicide in which a patient used as an anchor the top of a corridor door to hang himself (OIG 2019), We noted that case was particularly ironic, because it occurred at a VA hospital. The VA system has produced so many valuable resources on suicide prevention that we now use in hospitals world-wide.

We summarized lessons learned from that case:

• Use a tool like the VA Mental Health Environment of Care Checklist (MHEOCC) to guide your environment of care rounds on your behavioral health units.
• Make sure all relevant staff are appropriately trained on the MHEOCC.
• Strongly consider use of over-the-door alarms on your corridor doors on behavioral health units.
• Make sure your responsible staff understand their role in your 15-minute (or other designated interval) observations and that they are not multi-tasking during those responsibilities. Audit compliance with these protocols.
• When your security cameras malfunction for any reason, make sure the reasons for such malfunctions are promptly addressed and corrected.
• Your leadership needs to take an active role in oversight of your inpatient behavioral health units.

Subsequently, VA researchers undertook a study of all VA medical centers having behavioral health units. Mills et al. (Mills 2020) searched VHA databases for reports of suicide deaths and attempts on inpatient mental health units from January 2008 (when VHA began using over-the-door alarms) to June 2019.

Of 389 suicide attempt and suicide death events, 179 (46.0%) were due to hanging, including 6 deaths. Of those 179 reports of hanging, 127 (71.0%) used doors as the anchor point, including 4 of the deaths.

Of the 127 RCA and safety reports of hanging on a door, 44 (34.6%) cases involved an over-the-door alarm. And in every case involving an over-the-door alarm, the patient did not die. In 2 cases the patients were contemplating hanging but did not because they were aware of the over-the-door alarms. In 2 other cases the alarm did not go off.

The authors conclude that, though the association is not proof, the findings suggest that many deaths were likely averted by over-the-door alarms.

Perhaps just as importantly, there were lessons learned from those alarms that failed to go off. They illustrate the importance of testing and checking the alarms on a regular basis, and of continuing regular rounds and checks on the unit even with the alarms. Note that some over-the-door alarms apparently are capable of triggering an alert when the alarm needs maintenance. We’d still recommend manually checking those alarms regularly.

The data reviewed by Mills and colleagues also included information about the materials used as lanyards/nooses for the attempted hangings. Sheets as the lanyard material to form the noose in 69.3% of the reports and clothing or pajamas in 19.6%. The authors admit it would be difficult to eliminate all the lanyard material on a mental health unit as patients will have some type of bedding and pajamas or other clothes. But they do describe anti-ligature bedding that uses a one-piece bed cover that is too thick to use as a lanyard for hanging. They suggest that, coupled with the use of over-the-door alarms help to mitigate the risk of a suicide death by hanging.

Two of the root causes identified in the RCA’s of all the cases were:

• access to anchor points
• lack of visibility of patients in private areas.

The authors note that over-the-door alarm technology helps eliminate these hazards by removing a reliable anchor point, and alerting staff to patient attempts when out of view.

Environmental hazards are root causes or contributing factors in most suicide attempts. You’ll, of course, recognize the lead author Peter Mills as the architect of the widely used VA Mental Health Environment of Care Checklist (MHEOCC) that we’ve discussed in many of our columns. That checklist is available online on the VA Patient Safety website, as is an excellent video narrated by Peter Mills, MD. In our February 14, 2017 Patient Safety Tip of the Week “Yet More Jumps from Hospital Windows” we mentioned 2 publications (Watts 2016, Mills 2016) showing sustained results from implementation of the Mental Health Environment of Care Checklist (MHEOCC). The checklist and program became mandated at all VA hospitals in 2007. Inpatient suicide rates in VA hospitals dropped from 4.2 per 100,000 admissions to 0.74 per 100,000 admissions from 2000 to 2015. The reduction in suicides coincided with introduction of the MHEOCC and has been sustained since implementation in 2007. The authors stress that the physical changes brought about by the MHEOCC likely have a bigger impact on inpatient suicide reduction than the numerous other interventions used.

While you probably should install over-the-door alarms on all doors in your behavioral health units, keep in mind there are other situations in which that is not practical:

• the suicidal patient who must be housed on a non-behavioral health unit because of concomitant medical problems
• the behavioral health patient who is on an intrahospital transport (for example, to radiology)

We’ve certainly seen attempted suicides by hanging on general med/surg units or in bathrooms in the Radiology suite. In fact, most of our columns on hospital suicides address suicides in those non-behavioral health parts of hospitals.

We don’t know if any of the over-the-door alarms are “portable” and might be moved to non-behavioral health units as needed. But we have previously recommended that general hospitals which often have to house potentially suicidal patients on their non-behavioral health units consider dedicating one or two rooms to have special design similar to rooms on behavioral health units. That could easily include ligature-resistant doors and over-the-door alarms.

Some of our prior columns on preventing hospital suicides:

• January 6, 2009 “Preventing Inpatient Suicides”
• February 9, 2010 “More on Preventing Inpatient Suicides”
• March 16, 2010 “A Patient Safety Scavenger Hunt”
• December 2010 “Joint Commission Sentinel Event Alert on Suicide Risk Outside Psych Units”
• September 27, 2011 “The Canadian Suicide Risk Assessment Guide”
• December 2011 “Columbia Suicide Severity Rating Scale”
• July 2012 “VA Checklist Reduces Suicide Risk”
• August 2013 “Suicide Attempts on Med/Surg Units”
• August 25, 2015 “Checklist for Intrahospital Transport”
• October 6, 2015 “Suicide and Other Violent Inpatient Deaths”
• March 2016 “TJC Sentinel Event Alert on Preventing Suicide”
• April 12, 2016 “Falls from Hospital Windows”
• February 14, 2017 “Yet More Jumps from Hospital Windows”
• August 29, 2017 “Suicide in the Bathroom”
• December 12, 2017 “Joint Commission on Suicide Prevention”
• July 10, 2018 “Another Jump from a Hospital Window”
• September 18, 2018 “More on Hospital Suicides”
• January 22, 2019 “Wandering Patients”
• January 29, 2019 “National Patient Safety Goal for Suicide Prevention”
• July 30, 2019 “Lessons from Hospital Suicide Attempts”

• September 3, 2019 “Lessons from an Inpatient Suicide”

References:

OIG (Office of Inspector General). Department of Veterans Affairs. VHA (Veterans Health Administration). Patient Suicide on a Locked Mental Health Unit at the West Palm Beach VA Medical Center Florida. Healthcare Inspection Report #19-07429-195; August 22, 2019

https://www.va.gov/oig/pubs/VAOIG-19-07429-195.pdf

Mills PD, Soncrant C, Bender J, Gunnar W. Impact of over-the-door alarms: Root cause analysis review of suicide attempts and deaths on veterans health administration mental health units. General Hospital Psychiatry 2020; 64: 41-45

https://www.sciencedirect.com/science/article/abs/pii/S0163834320300219

Mental Health Environment of Care Checklist (VA)

http://www.patientsafety.va.gov/docs/MHEOCCed092016508.xlsx

video

http://www.patientsafety.va.gov/professionals/onthejob/mentalhealth.asp

Watts BV, Shiner B, Young-Xu Y, Mills PD. Sustained Effectiveness of the Mental Health Environment of Care Checklist to Decrease Inpatient Suicide. Psychiatric Services 2016; Published Online Ahead of Print: November 15, 2016

http://ps.psychiatryonline.org/doi/full/10.1176/appi.ps.201600080

Mills PD. Use of the Mental Health Environment of Care Checklist to Reduce the Rate of Inpatient Suicide in VHA. TIPS (Topics in Patient Safety) 2016; 16(3):  3-4 July/August/September 2016

http://www.patientsafety.va.gov/professionals/publications/newsletter.asp

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What's New in the Patient Safety World?

August 2020

·New Twist on Resident Work Hours and Patient Safety

·Fentanyl Patches in the Crosshairs Again

·Pulse Oximetry in Children

·Surgical Site Infections and Laparoscopy

New Twist on Resident Work Hours and Patient Safety

Over the years, we’ve done many columns on the question about the impact of resident work hours on patient safety. The debate has always been “Would you rather be cared for by a tired resident who knows you or a wide awake one who doesn’t know much about you?”. Of course, at this time we don’t have an unassailable answer to that question. Studies to date have had mixed results, some showing fewer errors in residents with more restricted work hours and others showing no change or even more errors.

It is indisputable that physiological changes and circadian rhythm disturbances in healthcare providers, such as fatigue and inattention, make errors more likely. There are plenty of studies now demonstrating deterioration in cognitive and physical skills with sleep deprivation or extended work shifts. For example, one recent study (Persico 2018) evaluated the cognitive performance (processing speed, working memory capacity, perceptual reasoning, and cognitive flexibility) of emergency physicians after a night shift of 14 hours (H14) and after a work shift of 24 hours (H24) and to compare it with tests performed after a rest night at home (H0). No cognitive ability was significantly altered after H14 compared with H0. But three of 4 cognitive abilities performance (processing speed, working memory capacity, and perceptual reasoning) were impaired at H24 compared with H0. Cognitive abilities were not different between residents and staff physicians (except for perceptual reasoning) and were not affected by the amount of sleep during the night shift.

Studies like these showing cognitive and performance deterioration with long shifts, and some well publicized incidents such as the Libby Zion case, led to the restriction of work hours for physicians in training. The Bell Commission, which developed the original residency workhour restrictions in New York State in the 1980’s, cited the more frequent occurrence of hospital incidents at night and on weekends as a sign of work-related fatigue. Back then, we pointed out to that commission that those are also times when there is more cross-coverage of patients and the covering physicians generally have less knowledge about the patients they cover. So the debate has ensued as to which is worse: errors related to fatigue or errors related to handoffs. It is fairly clear we must avoid fatigue as much as possible by adherence to workhour restriction rules. And we also need to focus on improvement of handoffs and other communication issues to improve patient safety.

Following the Bell Commission report in New York State, some states placed restrictions on the total number of work hours per week and number of consecutive work hours residents could work. Later, the ACGME developed similar guidelines restricting resident work hours to no more than 80 hours per week and no more than 16 consecutive hours. Then, in 2017, ACGME did backpeddle somewhat and allowed more flexible hours (shift of 24-28 consecutive hours were allowed).

In prior columns, we expressed our hope that 2 trials, the FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees) trial and the iCOMPARE (Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education) trial would provide clear cut answers to the fundamental question as to whether more restricted resident work hours had an impact one way or the other on patient safety and patient outcomes. Of course, the other important outcome anticipated from these studies was the impact on resident well-being.

We discussed the iCOMPARE trial in our April 2019 What's New in the Patient Safety World column “iCOMPARE Study on Resident Work Hour Rules”. iCOMPARE involved 63 internal-medicine residency programs that were randomized to a group with standard ACGME duty hours or to a group with more flexible duty-hour rules that did not specify limits on shift length or mandatory time off between shifts (but still complied with the 80 hour per week restriction). The primary outcome measure, change in 30-day mortality, was not significantly different between the two groups (Silber 2019). Differences in changes between the flexible programs and the standard programs in the unadjusted rate of readmission at 7 days, patient safety indicators, and Medicare payments were also not significantly different.

A companion paper from the iCOMPARE trial looked at the effects of flexible scheduling vs. strict scheduling on sleep, sleepiness, and alertness of medical trainees (Basner 2019). The researchers found no significant difference between the groups in total sleep duration (as measured by actigraphy) or sleepiness (as measured by the Karolinska Sleepiness Scale). But noninferiority of the flexible group for alertness (as measured by the brief computerized Psychomotor Vigilance Test) was not established.

They concluded that there was no more chronic sleep loss or sleepiness across trial days among interns in flexible programs than among those in standard programs. But both those measures were averages over time. Those in flexible-hour programs averaged 2.23 hours less sleep during night calls and the average was increased by sleeping more hours on days off. Also, those in flexible programs reported less alertness and more sleepiness after extended night shifts than during day shifts.

A third paper from the iCOMPARE trial (Desai 2018) found no significant between-group differences in the mean percentages of time that interns spent in direct patient care and education nor in trainees’ perceptions of an appropriate balance between clinical demands and education. Scores on in-training examinations also did not differ significantly between groups. But a survey of interns revealed that those in flexible programs were more likely to report dissatisfaction with multiple aspects of training, including educational quality (odds ratio 1.67), overall well-being (OR 2.47), and how the program affects their personal lives with friends and family (OR, 6.11).

We discussed the FIRST trial in our March 2016 What's New in the Patient Safety World column “Does the Surgical Resident Hours Study Answer Anything?”. In the FIRST trial (Bilimoria 2016), more flexible resident work hours were not associated with an increased rate of death or serious complications or residents’ perception of educational value but residents had more negative feelings about the impact on their personal lives with the more flexible hours

The FIRST (Flexibility in Duty Hour Requirements for Surgical Trainees) trial had found no significant difference in resident satisfaction with overall well-being and education between flexible and standard duty-hour policies after 1 year. Followup analysis in 2017 showed a decrease in negative perception of flexible duty-hour policies a year later. A survey of residents participating in the FIRST trial (Yang 2017) found that as PGY level increased, residents had increasing concerns about patient care and resident education and training under standard duty hour policies, but they had decreasing concerns about well-being under flexible policies. When given the choice between training under standard or flexible duty hour policies, only 14% of residents expressed a preference for standard policies. Khorfan et al. (Khorfan 2020) recently reported 4 year follow up to the FIRST trial. They found that, over time, there was a trend toward fewer 80-hour work week violations in the flexible arm (19.8% vs. 17.0%) and increased satisfaction with flexible duty-hours. Well-being decreased over time but this was seen in both arms. Residents in flexible duty-hour programs reported significantly fewer lapses in continuity than standard policy residents until all programs transitioned to flexibility in 2018.

So, did we have answers to our fundamental questions? Both the FIRST and iCOMPARE trials showed flexible resident work-hour policies have similar patient outcomes and resident educational values compared to the strict ACGME policies. That’s reassuring. It pretty much answers the question that we raised from the beginning: the issue of fatigue vs. increased handoffs/discontinuity appears to be a wash.

But, wait a minute! A new study (Landrigan 2020) compared two schedules for pediatric resident physicians during their intensive care unit (ICU) rotations: extended-duration work schedules that included shifts of 24 hours or more (control schedules) and schedules that eliminated extended shifts and cycled resident physicians through day and night shifts of 16 hours or less (intervention schedules). Resident physicians made more serious errors during the intervention schedules than during the control schedules (97.1 vs. 79.0 per 1000 patient-days; relative risk, 1.53). The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56). Those results are contrary to what the researchers would expect.

Aha, you say! Those who espouse the less knowledge/more handoffs theory will say this supports their position. But not so fast! There was considerable variation between results at participating hospitals. The patient demographics and complexity of illness could not explain the differences. Though the characteristics of the patient population were similar in the 2 arms of the study, the number of patients per resident was not. Those hospitals with the highest resident physician workloads had the most negative results with the intervention. In fact, residents in the intervention (limited hours) group had more ICU patients per resident than those in the control (24 or more hours) group (mean 8.8 vs. 6.7). Once the results were adjusted for the number of patients per resident physician as a potential confounder, intervention schedules were no longer associated with an increase in errors.

And, of course, we can’t discuss resident work hours without mention of handoffs. But we’ll simply refer you to our many columns listed below. The researchers in the Landrigan study did discuss the possibility that an increase in handoffs may have played a role in producing more errors. Handoffs did increase in number at all participating hospitals. However, only three sites had worse patient safety outcomes with the intervention schedule than with the extended-shift schedule, and one had substantially better safety outcomes with the intervention. The authors felt that suggests that the increase in handoffs overall was unlikely to account for the results.

The Landrigan study shows us 3 important things:

• bigger patient workloads likely lead to more errors
• we need to focus not just on work hours, but also on workload
• studies to address this critical question are very difficult to design

Finding the “sweet spot” between resident fatigue and well-being vs. patient safety and patient outcomes probably still requires further tweaking of both scheduling and workload. And, as John Birkmeyer pointed out in an editorial accompanying the FIRST trial results, we also need to factor in that much of the work formerly done primarily by residents is now done by others (Birkmeyer 2016). There has been increased involvement of intensivists, attending physicians and mid-level providers as part of interdisciplinary teams, and hospitalists often attend to many of the non-surgical aspects of patient care in surgical patients.

Some of our other columns on housestaff workhour restrictions:

December 2008           “IOM Report on Resident Work Hours”

February 26, 2008       “Nightmares: The Hospital at Night”

January 2010               “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 2011               “No Improvement in Patient Safety: Why Not?”

November 2011          “Restricted Housestaff Work Hours and Patient Handoffs”

January 3, 2012           “Unintended Consequences of Restricted Housestaff Hours”

June 2012                    “Surgeon Fatigue”

November 2012          “The Mid-Day Nap”

December 10, 2013     “Better Handoffs, Better Results”

April 22, 2014             “Impact of Resident Workhour Restrictions”

January 2015               “More Data on Effect of Resident Workhour Restrictions”

August 2015               “Surgical Resident Duty Reform and Postoperative Outcomes”

September 2015          “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”

March 2016                 “Does the Surgical Resident Hours Study Answer Anything?”

April 2019                   “iCOMPARE Study on Resident Work Hour Rules”

Read about many other handoff issues (in both healthcare and other industries) in some of our previous columns:

May 15, 2007              “Communication, Hearback and Other Lessons from Aviation”

May 22, 2007              “More on TeamSTEPPS™”

August 28, 2007         “Lessons Learned from Transportation Accidents”

December 11, 2007     “Communication…Communication…Communication”

February 26, 2008       “Nightmares….The Hospital at Night”

September 30, 2008     “Hot Topic: Handoffs”

November 18, 2008     “Ticket to Ride: Checklist, Form, or Decision Scorecard?”

December 2008            “Another Good Paper on Handoffs”.

June 30, 2009               “iSoBAR: Australian Clinical Handoffs/Handovers”

April 25, 2009             “Interruptions, Distractions, Inattention…Oops!”

April 13, 2010             “Update on Handoffs”

July 12, 2011              “Psst! Pass it on…How a kid’s game can mold good handoffs”

July 19, 2011              “Communication Across Professions”

November 2011           “Restricted Housestaff Work Hours and Patient Handoffs”

December 2011            “AORN Perioperative Handoff Toolkit”

February 14, 2012       “Handoffs – More Than Battle of the Mnemonics”

March 2012                 “More on Perioperative Handoffs”

June 2012                    “I-PASS Results and Resources Now Available”

August 2012               “New Joint Commission Tools for Improving Handoffs”

August 2012                “Review of Postoperative Handoffs”

January 29, 2013         “A Flurry of Activity on Handoffs”

December 10, 2013     “Better Handoffs, Better Results”

February 11, 2014       “Another Perioperative Handoff Tool: SWITCH”

March 2014                  “The “Reverse” Perioperative Handoff: ICU to OR”

September 9, 2014      “The Handback”

December 2014            “I-PASS Passes the Test”

January 6, 2015            “Yet Another Handoff: The Intraoperative Handoff”

March 2017                 “Adding Structure to Multidisciplinary Rounds”

August 22, 2017         “OR to ICU Handoff Success”

October 2017              “Joint Commission Sentinel Event Alert on Handoffs”

October 30, 2018        “Interhospital Transfers”

April 9, 2019               “Handoffs for Every Occasion”

November 2019          “I-PASS Delivers Again”

References:

Persico N, Maltese F, Ferrigno C, et al. Influence of Shift Duration on Cognitive Performance of Emergency Physicians: A Prospective Cross-Sectional Study. Ann Emerg Med 2018; 72(2): 171-180

https://www.annemergmed.com/article/S0196-0644(17)31769-9/fulltext?code=ymem-site

Silber JH, Bellini LM, Shea JA, et al. Patient Safety Outcomes under Flexible and Standard Resident Duty-Hour Rules. N Engl J Med 2019; 380: 905-914

https://www.nejm.org/doi/full/10.1056/NEJMoa1810642

Basner M, Asch DA, Shea JA, et al. Sleep and Alertness in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med 2019; 380: 915-923

https://www.nejm.org/doi/full/10.1056/NEJMoa1810641

Desai SV, Asch DA, Bellini LM, et al. Education Outcomes in a Duty-Hour Flexibility Trial in Internal Medicine. N Engl J Med 2018; 378: 1494-1508

https://www.nejm.org/doi/full/10.1056/NEJMoa1800965

Bilimoria KY, Chung JW, Hedges LV, et al. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training. N Engl J Med 2016; 374: 713=727 published online first February 2, 2016

https://www.nejm.org/doi/full/10.1056/NEJMoa1515724?query=TOC

Yang AD, Chung JW, Dahlke AR, et al. Differences in Resident Perceptions by Postgraduate Year of Duty Hour Policies: An Analysis from the Flexibility in Duty hour Requirement for Surgical Trainees (FIRST) Trial. Journal of the American College of Surgeons 2017; 224(2): 103-112 Published online November 4, 2016

https://www.journalacs.org/article/S1072-7515(16)31591-5/abstract

Khorfan R, Yuce TK, Love R, et al. Cumulative Effect of Flexible Duty-hour Policies on Resident Outcomes, Annals of Surgery 2020; 271(5): 791-798

https://journals.lww.com/annalsofsurgery/Fulltext/2020/05000/Cumulative_Effect_of_Flexible_Duty_hour_Policies.1.aspx

Landrigan CP, Rahman SA, Sullivan JP, et al. Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts. N Engl J Med 2020; 382: 2514-2523

https://www.nejm.org/doi/full/10.1056/NEJMoa1900669?query=TOC

Birkmeyer JD. Surgical Resident Duty-Hour Rules - Weighing the New Evidence (editorial). N Engl J Med 2016; 374:783-784 published online first February 2, 2016

https://www.nejm.org/doi/full/10.1056/NEJMe1516572?query=TOC

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Fentanyl Patches in the Crosshairs Again

In multiple columns we have highlighted the dangers of long-acting and/or extended-release opioids. These formulations are not intended for use as first-line agents in opioid-naïve patients. The newer opiate formulations are either more potent or designed to produce a longer peak action, two characteristics that lead to some of the greatest dangers. These have been designed to be used in patients who are opioid-tolerant and have pain of a chronic nature that has not been controlled with more conventional opiates. They were not intended to be used for treatment of acute pain nor to be used as first line agents in patients with pain. But in practice they are often being (mis)used in that way. And, unfortunately, these preparations became a prime driver of the opioid epidemic in the US.

One of those extended release opioid preparations is the fentaNYL patch. We’ve discussed problems with these patches in our Patient Safety Tip of the Week for September 13, 2011 “Do You Use Fentanyl Transdermal Patches Safely?” and our What's New in the Patient Safety World columns for May 2012 “Another Fentanyl Patch Warning from FDA”, March 2013 “Try Googling Fentanyl Accidents”, September 2013 “ISMP Outreach on Fentanyl Patch Safety”, and February 2020 “The FDA and Long-Acting Opioids”.

ISMP recently reported on a bothersome potential trend (ISMP 2020). They noted an uptick in prescriptions for fentaNYL patches in elderly opioid-naïve patients discharged from hospitals or emergency departments. ISMP, of course, reiterates that fentaNYL patches, like other long-acting or extended release opioids, are not appropriate for opioid-naïve patients. They do note some factors that may have contributed to physicians inappropriately prescribing these. One obvious one is not understanding they should not be used in opioid-naïve patients. But another was physicians not understanding what the terms “opioid-naïve” or “opioid-tolerant” mean. ISMP provides a definition of “opioid-tolerant” from the prescribing information for fentaNYL patches. Another contributing factor was mistaking an opioid side effect as evidence of an allergy to a specific opioid, which apparently led at least one prescriber to think a fentaNYL patch was the only option. Lastly, a patient request for an opioid patch may have also played a role in one case.

ISMP has some suggestions to help prevent such inappropriate prescribing of fentaNYL patches. They recommend interactive alerts requiring confirmation that the patient is opioid-tolerant and experiencing chronic pain at the time healthcare professionals are entering orders or prescribing fentaNYL patches (and this should include the emergency department). Hard stops could be used if the patient does not meet criteria for being “opioid-tolerant”. They also recommend creating a daily list of discharge prescriptions and transfer orders for fentaNYL patches generated from the order entry system. Hospital pharmacists should then review the orders and prescriptions to verify that the patient is opioid-tolerant and has chronic pain. 

ISMP’s second recommendation has to do with distinguishing between true allergies and drug intolerances. (You’ll recall we just discussed this issue in our July 21, 2020 Patient Safety Tip of the Week “Is This Patient Allergic to Penicillin?”). ISMP recommends that, when allergy information is collected, include prompts to obtain and document in a standardized manner the reaction type (e.g., side effect, intolerance, toxicity, immune response) and description (e.g., rash, pruritus, swelling, anaphylaxis). Before prescribing medications, allergy information without a documented reaction type and description should be reconciled with the patient or caregiver so crucial medications are not avoided simply due to mild intolerances.

Of course, there are lots of other issues associated with opioid transdermal patches.

They are also now frequent causes of accidental overdoses, including those for whom they were not prescribed such as children and pets that are attracted to the shiny wraps. And transdermal patches can lead to burns if a patient wearing one undergoes an MRI scan. Another problem is failure to remove the old patch when a new one is put on, resulting in excessive fentanyl levels.

Now is a good time for all hospitals (and other healthcare organizations) to review their clinical decision support (CDSS) tools to see if they can help avoid inappropriate use of fentanyl patches or other long-acting or extended release opioid formulations. A very bothersome occurrence was noted recently in which a vendor included in an EHR CDSS alerts that actually steered providers to inappropriately order certain extended-release opioids (Taitsman 2020).

Our prior articles pertaining to long-acting and/or extended release preparations of opioids:

• April 2010                   “RCA: Epidural Solution Infused Intravenously”
• July 13, 2010              “Postoperative Opioid-Induced Respiratory Depression”
• January 18, 2011         “More on Medication Errors in Long Term Care”
• April 12, 2011             “Medication Issues in the Ambulatory Setting”
• June 28, 2011              “Long-Acting and Extended-Release Opioid Dangers”
• September 13, 2011    “Do You Use Fentanyl Transdermal Patches Safely?”
• November 8, 2011      “WHO’s Multi-Professional Patient Safety Curriculum Guide”
• May 2012                    “Another Fentanyl Patch Warning from FDA”
• July 24, 2012              “FDA and Extended-Release/Long-Acting Opioids”
• September 2012          “Joint Commission Sentinel Event Alert on Opioids”
• March 2013                 “Try Googling Fentanyl Accidents”
• September 2013          “ISMP Outreach on Fentanyl Patch Safety”
• October 2013              “Opioid Safety Actions and Resources”
• February 24, 2015       “More Risks with Long-Acting Opioids”
• February 2017             “FDA Approves Even More Long-Acting Opioids”
• February 12, 2019       “2 ER Drug Studies: Reassurances and Reservations”
• February 2020             “The FDA and Long-Acting Opioids”

References:

ISMP (Institute for Safe Medication Practices). Inappropriate FentaNYL Patch Prescriptions at Discharge for Opioid-Naïve, Elderly Patients. IMSP Medication Safety Alert! Acute Care Edition 2020; July 2, 2020

https://www.ismp.org/resources/inappropriate-fentanyl-patch-prescriptions-discharge-opioid-naive-elderly-patients

Taitsman JK, VanLandingham A, Grimm CA. Commercial Influences on Electronic Health Records and Adverse Effects on Clinical Decision-making. JAMA Intern Med 2020; 180(7): 925-926

https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2764862?resultClick=1

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Pulse Oximetry in Children

Anything we can do to reduce the risk of alarm fatigue is welcome. The most obvious one we’ve discussed is eliminating unnecessary telemetry monitoring. But, perhaps the next most obvious one is reducing pulse oximetry alarms that are not clinically important.

Continuous pulse oximetry monitoring is commonly performed in hospitalized children. An expert panel, utilizing the best evidence in the literature plus their own experience, recently utilized a modified Delphi Method to evaluate the need for continuous vs. intermittent pulse oximetry monitoring in a variety of conditions in hospitalized children outside the ICU (Schondelmeyer 2020).

For children with mild or moderate asthma, croup, pneumonia, and bronchiolitis, the panel recommended intermittent vital sign or oximetry measurement only. For those with severe disease in each respiratory condition as well as for a new or increased dose of intravenous opiate or benzodiazepine, the panel recommended continuous monitoring.

Children receiving supplemental oxygen should have continuous oximetry monitoring, but they should be transitioned from continuous monitoring to intermittent monitoring within 1 hour of achieving stable oxygen saturation levels of at least 90%.

We’ve, of course, done many columns on the dangers of respiratory depression by opioids or sedating agents. The panel recommends that intravenous opioid or benzodiazepine therapy requires continuous cardiorespiratory and oximetry monitoring only when there is a new medication or an increased dose of a current medication. Intermittent monitoring is otherwise sufficient.

We’re not so sure about the latter recommendation. Hypoxemia is a relatively late manifestation of drug-induced respiratory depression. Hypercapnia occurs before there is a significant reduction in oxygen saturation in most instances. It’s probably more appropriate to be using capnography to monitor patients receiving drugs that may depress respiration, such as opioids and benzodiazepines. We’ve certainly seen patients become obtunded while they still had good oxygen saturations, even on continuous pulse oximetry monitoring. If capnography is not available in such circumstances, we’d still feel more comfortable using continuous rather than intermittent pulse oximetry.

The panel did acknowledge there is a relative dearth of high quality evidence in the literature, which consists primarily of observational study designs, and that there was little or no evidence for some of the respiratory conditions.

Overall, the panel recommended that intermittent vital sign assessment is appropriate for most mild-moderate forms of childhood respiratory illnesses. For patients weaned from oxygen, transitioning to intermittent oximetry within one hour is appropriate.

There’s no question these new guidelines would significantly reduce alarms on pediatric units and, thus, reduce the risk of alarm fatigue.

Some of our previous columns on opioid safety issues in children:

• September 2012 “FDA Warning on Codeine Use in Children Following Tonsillectomy”
• March 2013 “Further Warning on Codeine in Children Following Tonsillectomy”
• May 2014 “Pediatric Codeine Prescriptions in the ER”
• November 2015 “FDA Safety Communication on Tramadol in Children”
• January 2016 “FDA Gets Even Tougher on Codeine in Kids”
• October 2016 “Another Codeine Warning for Children”
• May 2017 “FDA Finally Restricts Codeine in Kids; Tramadol, Too”
• February 2018 “FDA Warning on Cough Meds”

Prior Patient Safety Tips of the Week pertaining to alarm-related issues:

• March 5, 2007 “Disabled Alarms”
• March 26, 2007 “Alarms Should Point to the Problem”
• April 2, 2007 “More Alarm Issues”
• June 19, 2007 “Unintended Consequences of Technological Solutons”
• April 1, 2008 “Pennsylvania PSA’s FMEA on Telemetry Alarm Interventions”
• February 23, 2010 “Alarm Issues in the News Again”
• March 2, 2010 “Alarm Sensitivity: Early Detection vs. Alarm Fatigue”
• March 16, 2010 “A Patient Safety Scavenger Hunt”
• November 2010 “Alarms in the Operating Room”
• February 22, 2011 “Rethinking Alarms”
• February 2013 “Joint Commission Proposes New 2014 National Patient Safety Goal”
• May 2013 “Joint Commission Sentinel Event Alert: Alarm Safety”
• July 2, 2013 “Issues in Alarm Management”
• August 2013 “Joint Commission Formalizes 2014 NPSG on Alarm Management”
• February 4, 2014 “But What If the Battery Runs Low?”
• October 2014 “Alarm Fatigue: Reducing Unnecessary Telemetry Monitoring”
• December 15, 2015 “Vital Sign Monitoring at Night”
• February 9, 2016 “It was just a matter of time…”
• August 16, 2016 “How Is Your Alarm Management Initiative Going?”
• February 21, 2017 “Alarm Fatigue in the ED”
• April 18, 2017 “Alarm Response and Nurse Shift Duration”
• April 25, 2017 “Dialysis and Alarm Fatigue”
• October 17, 2017 “Progress on Alarm Management”
• November 21, 2017 “OSA, Oxygen, and Alarm Fatigue”
• May 1 2018  “Refrigerator Alarms”
• April 16, 2019 “AACN Practice Alert on Alarm Management”
• September 2019 “Alarm Fatigue in the Emergency Room”
• October 8, 2019 “Another Freezer Accident”
• June 23, 2020 “Telemetry Incidents”

Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:

• January 4, 2011           “Safer Use of PCA”
• July 13, 2010              “Postoperative Opioid-Induced Respiratory Depression”
• May 12, 2009              “Errors With PCA Pumps”
• September 21, 2010    “Dilaudid Dangers”
• November 2010          “More on Preoperative Screening for Obstructive Sleep Apnea”
• February 22, 2011       “Rethinking Alarms”
• May 17, 2011              “Opioid-Induced Respiratory Depression – Again!”
• September 6, 2011      “More Tips on PCA Safety”
• December 6, 2011       “Why You Need to Beware of Oxygen Therapy”

• February 21, 2012       “Improving PCA Safety with Capnography”

• September 2012          “Joint Commission Sentinel Event Alert on Opioids”
• September 2012          “FDA Warning on Codeine Use in Children Following Tonsillectomy”
• July 3, 2012                “Recycling an Old Column: Dilaudid Dangers”
• February 12, 2013       “CDPH: Lessons Learned from PCA Incident”
• February 19, 2013       “Practical Postoperative Pain Management”
• May 6, 2014                “Monitoring for Opioid-induced Sedation and Respiratory Depression”
• March 3, 2015             “Factors Related to Postoperative Respiratory Depression”
• June 2, 2015                “Reminders of Dilaudid Dangers”
• August 11, 2015         “New Oxygen Guidelines: Thoracic Society of Australia and NZ”
• August 18, 2015         “Missing Obstructive Sleep Apnea”
• December 2015           “Opioid Alert Fatigue”
• March 2016                 “Guideline for Management of Postoperative Pain”
• June 14, 2016              “Nursing Monitoring of Patients on Opioids”
• October 11, 2016        “New Guideline on Preop Screening and Assessment for OSA”
• December 6, 2016       “Postoperative Pulmonary Complications”
• May 2017                    “Another Twist in Opioid-Induced Respiratory Depression”
• June 2017                    “Masterpiece: Monitoring for Opioid-Induced Respiratory Depression”
• June 20, 2017              “Dilaudid Dangers #4”
• October 3, 2017           “Respiratory Compromise: One Size Does Not Fit All”
• November 2017          “Bad Combination: Gabapentin and Opioids”
• November 21, 2017    “OSA, Oxygen, and Alarm Fatigue”
• July 31, 2018              “Surgery and the Opioid-Tolerant Patient”
• February 12, 2019       “2 ER Drug Studies: Reassurances and Reservations”
• March 2019                 “Gabapentin and Pregabalin on the Radar Screen”
• June 18, 2019              “Found Dead in a Bed”
• January 2020               “FDA Warning on Gabapentinoids”
• January 2020               “Opioids and Apnea: Not Just Surgical Patients”

• Tools:                          PCA Pump Audit Tool and the PCA Pump Criteria
  

References:

Schondelmeyer AC, Dewan ML, Brady PW, et al. Cardiorespiratory and Pulse Oximetry Monitoring in Hospitalized Children: A Delphi Process. Pediatrics 2020; e20193336

https://pediatrics.aappublications.org/content/early/2020/07/15/peds.2019-3336

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Surgical Site Infections and Laparoscopy

Most of us have always thought about laparoscopic procedures for non-malignant gynecological conditions to be relatively benign procedures. But data from a recent randomized controlled trial at a tertiary university-affiliated center showed some surprising results (Dior 2020). Surgical site infections (SSI’s) occurred in 16.3% of cases, with organ or space infection in 6.6% and port-site infection in 10.2%.

The study was actually a randomized controlled trial (RCT) looking to see if there was a difference in SSI rates when using different skin disinfectants. 221 patients were randomized to have their skin prepared preoperatively with water-based povidone-iodine, 220 were randomized to alcohol-based povidone-iodine, and 220 were randomized to alcohol-based chlorhexidine. Patients were blinded to the solution used to clean their skin. The researchers found that no skin preparation solution provided an advantage compared with the other solutions in reducing infection rates. But the somewhat surprising finding was the relatively high rates of SSI’s regardless of the skin preparation used. The authors conclude that further research efforts are needed to find ways to reduce these SSI rates.

We wonder how many hospitals even know what their SSI rates are for these laparoscopic procedures. Do you know your rates?

References:

Dior UP, Kathurusinghe S, Cheng C, et al. Effect of Surgical Skin Antisepsis on Surgical Site Infections in Patients Undergoing Gynecological Laparoscopic Surgery: A Double-Blind Randomized Clinical Trial. JAMA Surg 2020; Published online July 08, 2020

https://jamanetwork.com/journals/jamasurgery/article-abstract/2768004?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamasurg.2020.1953

Print “August 2020 Surgical Site Infections and Laparoscopy”

Print “August 2020 What's New in the Patient Safety World (full column)”

Print “August 2020 New Twist on Resident Work Hours and Patient Safety”

Print “August 2020 Fentanyl Patches in the Crosshairs Again”

Print “August 2020 Pulse Oximetry in Children”

Print “August 2020 Surgical Site Infections and Laparoscopy”



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