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February 14, 2017
Yet More Jumps from Hospital Windows
A patient jumps to his or her death from a hospital window. Think that could never happen at your non-psychiatric hospital? Think again. Last year we described 2 such cases (see our April 12, 2016 Patient Safety Tip of the Week “Falls from Hospital Windows”) and we’ve come across several additional cases since then. We wouldn’t be surprised if there are other cases that we simply have not heard about. There are also many news headlines about patients who have jumped from hospital windows that provide no details.
Suicide on non-behavioral health units has been a topic of several of our columns and also one of Joint Commission’s sentinel event alerts (see our December 2010 What’s New in the Patient Safety World column “Joint Commission Sentinel Event Alert on Suicide Risk Outside Psych Units”). But not all jumps from windows are suicide attempts. In many cases it is a confused patient trying to escape from the hospital. The two cases we described in our April 12, 2016 Patient Safety Tip of the Week “Falls from Hospital Windows” had traumatic brain injuries.
In one of the cases we’ve subsequently come across (Pearson 2016) a 25 y.o. man who had attempted an overdose with aspirin and multivits was on a “crisis stabilization” unit on the third floor (that hospital’s main behavioral health unit is on first floor). The patient “launched” himself off the bed and through the window, even while he was under direct observation. When found, he had “medical wires still connected”.
In another case (Bay Bulletin 2016) a man‚ age 29‚ had been admitted to hospital for alcohol-related issues on a Saturday before the incident the next morning‚ Christmas Day. He ran away from a doctor‚ broke the window and fell from the fifth floor to the ground.” Both his legs were fractured in the fall and he suffered a serious head injury and subsequently died.
In another (Hutton 2014) a 39 y.o. man suffering from alcohol withdrawal threw himself out of a fourth-floor window after he became disorientated and confused while waiting for a psychiatric review. His condition had stabilized over three days but his state of mind went from “jovial and chirpy” to “confused” until the night of his death when he began wandering around the ward incoherently before running away from the two nurses monitoring him, locking himself in a room, breaking the security locks on windows and throwing himself out.
Even the elderly may be at risk. An 80 y.o. man admitted for elderly care was left unattended in day room and broke window with a chair, crawled onto a ledge and fell to his death from second floor (Jolly 2016).
And not all victims are males. A female patient in her 40’s on acute medical unit jumped to death from window (Yorkshire Evening Post 2014). No other details were provided. An older case (Associated Press 2002) again involved a head-injured patient but the patient was female. She was located in the hospital’s head trauma unit on the 11th floor. She apparently was in some sort of restraints. A hospital worker heard a scuffling sound as he tended to the other patient in the room but events transpired so quickly that "by the time he heard the noise and went over, the person had already broken from the restraints" and squeezed through the 18-inch high opening of the large window in her room and fell fatally seven stories before hitting the roof of another building.
And the most recent case, which led to today’s column, comes from another statement of deficiencies/plan of correction from the California Department of Public Health (CDPH 2016). A patient with auditory hallucinations attempted suicide by stabbing himself in the chest and neck, resulting in hospital admission as a trauma patient. He had a hemothorax and needed chest tube insertion. He was under 1:1 observation in a trauma/medical/surgical unit on the hospital’s 10th floor. He suddenly “launched himself” up off his bed and out the window, breaking the window pane and falling 60 feet to his death on a 4th floor roof top. As we usually find with the reports from the CDPH, this case had numerous lessons learned. While several communication issues contributed, there were important lessons about the dangers in the environment that contributed or were otherwise hazardous (discussed below).
Even though we lack details on many of these cases, there clearly is a pattern. Moreover, there are some surprisingly simple issues that are actually very good lessons learned. The typical patient is a young or middle-aged male, but occasionally elderly patients or females have also jumped through or out of windows. The patient is often admitted for an attempted suicide but, again, not always. Typically he/she is confused or hallucinating. It’s not just patients with known psychiatric disorders or a history of suicide attempt that are at risk. Patients with brain injuries or delirium are at risk, particularly those who have demonstrated a tendency to wander or have verbalized their intent to “get out of here” or “go home”. And the incidents have commonly occurred while patients are already on 1:1 continuous observation and the observer is actually in the room.
In patients committing suicide, we often see that a period of greater vulnerability when their depression is improving. The same probably applies to the patient with traumatic brain injury (TBI) and staff need to be aware that the impulsivity often seen after TBI accompanied by the desire to go home can lead to the sort of disastrous consequences unfortunately seen in many of these cases.
Most general acute care hospitals have not installed the type of window used on behavioral health units that is not breakable or subject to manipulation. But perhaps it might be reasonable to designate one or two rooms on acute care floors for housing such patients deemed at risk and install such windows in those rooms. And, given that many such victims have been head trauma patients, perhaps it would be wise to install such windows on any acute head trauma units or other units dealing with TBI patients. But be wary that even windows you may consider “safe” may not be. At one hospital a male patient (no further details) removed a metal grill from a third floor window and fell out (Malloy 2016). The hospital subsequently checked the “safety restrictors” on all their windows.
But at a minimum, every room that is to be used for such patients needs a thorough environemental assessment such as the VA’s Mental Health Environment of Care Checklist. Particularly in a room where medical equipment is being used there will be special dangers. For example, in the CDPH case discussed above the patient’s oxygen had been discontinued but the mask, tubing, etc. were still in the room. These are objects that can be used by a patient to hang himself or otherwise injure himself. So make sure that medical equipment and supplies that are no longer needed are promptly removed from the room. The environmental assessment should also evaluate the immediate surroundings. For example, in that CDPH case there was a stairway exit 15 feet from the patient’s room with a door that was unlocked. (Note that we’ve discussed the VA’s Mental Health Environment of Care Checklist in several columns and will probably do another soon. Recent studies (Watts 2016, Mills 2016) have shown that it has been very successful in reducing suicides, perhaps more important than any other interventions.)
So what are the more subtle lessons learned? First is that several patients were able to stand up on the bed and “launch themselves” through the window from the bed. That implies a proximity of the bed to the window. So one key lesson is to position the patient’s bed in the room at a reasonable distance away from the window so such “launches” are not possible.
Second, positioning of the observer may be important. The observer is usually positioned in the room on the side away from the window and near the door. We suspect that is intentional and may be a consideration for the safety of the observer plus it would allow the observer to easily yell for help if necessary. But that obviously needs to be rethought.
And some other less obvious equipment needs to be removed: the second bed in a 2-bed room should probably be temporarily moved. That can only hinder someone from attempting to rescue a patient who is trying to jump out of a window.
And since the patient often uses an object in the room to break the window, such as a chair or piece of medical equipment, care must be taken to make sure such objects are not in reach for a patient even for a very brief time. For example, if the observer needs to briefly leave the room perhaps the chair should be removed.
We’ve also discussed before the importance of adequate training for the personnel designated as observers. Most people assigned as observers on med/surg floors have never worked in behavioral health units or even worked with behavioral health patients. Often they are not even healthcare personnel (some hospitals have utilized security personnel as observers) and may not have been adequately trained to recognize red flags or trained in de-escalation techniques.
And don’t forget that intrahospital patient transports may also be vulnerable events. You’ve heard us talk on several occasions about the “Ticket to Ride” concept in which a formal checklist is completed for all transports (eg. to radiology). Such checklists typically contain information related to adequacy of any oxygen supplies and medications needed but should also include information about things like suicide risk and wandering/elopement risk. These all need to be conveyed to the caregiver who may be accepting the patient in the new area. Just as we’ve talked about cases where a patient may attempt suicide in a bathroom in the radiology suite that is not suicide-proofed, a patient at risk for wandering or elopement may wander off easily while waiting in the radiology suite if not appropriately supervised. We also hope that you’ve checked those bathrooms in radiology for loopables and other implements that might be used in a suicide attempt (see our March 16, 2010 Patient Safety Tip of the Week “A Patient Safety Scavenger Hunt”).
Staff on med/surg units, ICU’s and rehab units need to be aware of risk factors for wandering, elopement, suicide or other impulsive behavior just as much as staff on behavioral health units do. Doing risk assessments and ensuring that staff caring for at-risk patients are adequately trained in dealing with such patients is important. When high-risk patients are identified it is also important to ensure they are not left alone in rooms with windows that can be opened (or broken) by patients and appropriate environmental assessments done to minimize the chance a patient may harm him/herself.
Some of our prior columns on preventing hospital suicides:
See our previous columns on wandering, eloping, and missing patients:
Pearson K. Investigation continues into man's death by jumping from Winter Haven hospital window. Girlfriend talked to him hours before, said he showed no signs of self-harm. The Ledger 2016; Published: Monday, April 25, 2016
Bay Bulletin. Port Elizabeth - Patient Dies After Jumping From Livingstone Hospital Window. Bay Bulletin 2016; December 28, 2016
Hutton A. Patient died after jumping from hospital window, inquest hears. Camden New Journal (UK) 2014; 14 February 2014
Jolly L. Vulnerable man, aged 80, dies after jumping through third-floor window at Paisley's Royal Alexandra Hospital. Daily Record (UK) 2016; 20 June 2016
Yorkshire Evening Post. Changes ordered following patient’s jump from Leeds hospital window. Yorkshire Evening Post (UK) 2016; 2 June 2014
Associated Press. Patient jumps to her death from 11th story of Miami hospital.
StAugustine.com. April 8, 2002
CDPH (California Department of Public Health). Complaint Intake Number CA00397967; 2016
(suicidal patient in acute care setting)
Malloy T. Patient falls from window at Weston General Hospital after removing safety grill. SomersetLive 2016; August 12, 2016
VA Mental Health Environment of Care Checklist (MHEOCC).
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
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
February 21, 2017
Alarm Fatigue in the ED
Ten years ago in one of our first columns we presented a case resulting in the death of a young patient in the emergency department (ED) because of alarm fatigue (see our April 2, 2007 Patient Safety Tip of the Week “More Alarm Issues”). In the investigation of that case we found that the volume of certain alarms were turned down, not just once but many times. In the root cause analysis of that case two major contributors were faulty ED design and an ED culture that had accepted turning down alarm volumes to avoid distraction. In both the literature and our own subsequent experiences we’ve encountered numerous instances where well intentioned healthcare workers have similarly turned off or volumed down alarms, putting patient safety at risk. While alarm fatigue is a complicated issue, site and equipment design and the culture of safety are only parts of the puzzle. The sheer volume of alarms is a major contributing factor and multiple studies have demonstrated that very large percentages of alarms are triggered for reasons that do not lead to any clinical intervention. So reducing unnecessary use of alarms is one of the key strategies to managing alarms and reducing alarm fatigue.
In our many discussions on alarm fatigue we have noted that a reduction in the number of patients unnecessarily on telemetry or cardiac monitoring is one of the best ways to reduce alarms and thereby reduce alarm fatigue (see our Patient Safety Tips of the Week for July 2, 2013 “Issues in Alarm Management” and August 16, 2016 “How Is Your Alarm Management Initiative Going?” for good summaries). We’ve noted the ACC/AHA Practice Standards for Electrocardiographic Monitoring in Hospital Settings (Drew 2004) and how adherence to those standards has helped many hospitals significantly reduce unnecessary use of telemetry.
Typically it is much harder to get physician buy-in into discontinuing telemetry or cardiac monitoring. We physicians often think “this will be an added measure of safety just in case…” We tend to think there is no downside to our own patient being continued on monitoring, without realizing the impact that unnecessary monitoring has in contributing to alarm fatigue which may adversely affect multiple other patients.
While much of our discussion on alarm fatigue has focused on inpatients and ICU patients, the ED (emergency department) is another area prone to alarm fatigue. Patients being evaluated for chest pain are commonly placed on cardiac monitors while they are being evaluated. In addition to contributing to alarm fatigue, unnecessary cardiac monitoring utilizes valuable resources that could be better used for other patients. Given that the incidence of arrhythmias is actually low in such patients, one group of clinical researchers developed a tool to help physicians determine which patients could have their cardiac monitoring discontinued in the ED (Gatien 2007). The Ottawa Chest Pain Cardiac Monitoring Rule is a very simple rule, based on only two parameters. It states that a patient (in the ED) with chest pain can be removed from cardiac monitoring on initial physician assessment if:
That clinical decision rule was developed from analysis of 992 consecutive chest pain patients were monitored in the ED, of whom 14% and 12% had myocardial infarction and unstable angina, respectively. There were only 17 patients (1.7%) with serious arrhythmias detected in the ED. The rule developed had 100% sensitivity for serious arrhythmias. The authors estimated that applying this rule would have allowed physicians to immediately remove 29% of patients from cardiac monitoring.
We have not seen widespread adoption of the decision rule in practice in ED’s. But now the same group of Canadian researchers has prospectively validated the tool (Syed 2017). A total of 1125 patients with chest pain seen in 2 busy ED’s in Ottawa, Ontario were enrolled in the study, 71% of whom were monitored during their ED stay. Only 15 (1.9%) had an arrhythmia within 8 hours that required intervention. The clinical decision rule detected all 15 for a sensitivity of 100% without missing any patients. Specificity was 36.4% but the negative predictive value was 100%. So their results were almost identical to those found in the original derivation study. The authors note that application of the decision rule would have allowed 36% of all such ED patients to have been removed from cardiac monitoring.
Remember, this rule applies to chest pain patients seen in the ED. It does not apply to patients in other settings, such as inpatient or ICU settings, or to ED patients with other problems. Note also that the rule does not determine which patients should initially be placed on cardiac monitoring. Rather, the rule applies to discontinuation of such monitoring. Also, it does not mean that such patients are ready for discharge from the ED. It simply means they can be moved to a non-monitored part of the ED, freeing up resources for other patients to use.
The authors cannot explain the inordinately long period between the derivation study and this validation study. Also, this current study was performed in the same hospital system that was used for the original study. So validation in other patient populations in other hospitals would be very helpful. So US hospitals – get with it! Do a multi-hospital validation study. Who could argue against a decision rule so simple to administer which has the opportunity to reduce unnecessary utilization of resources and reduce the risk of alarm fatigue?
The ED is relatively neglected in the literature on alarm fatigue. One particularly good article was in Patient Safety and Quality Healthcare by Kathryn Pelczarski of the ECRI Institute (Pelczarski 2013). While that article describes many of the elements we use in alarm management initiatives in general, it does a good job of pointing out some of the issues that are unique to the ED environment. One example is failure to put the bedside monitor in stand-by mode when the monitor is only being used for vital sign spot checks rather than continuous monitoring. Similarly, failure to put the bedside monitor in stand-by mode when ED patients go off to radiology or elsewhere for testing, as they commonly do. And many ED’s have to make use of stand-alone monitors rather than monitors connected to a central monitoring site. Many of these may be in more remote areas in which it is difficult to hear alarms or in isolation rooms where it is also difficult to hear the alarms. The article has good recommendations regarding alarm notification processes, designation of responsibility, and escalating response procedures.
We do have caveats on a couple of the recommendations in the Pelczarski article. One is the recommendation of moving non-networked monitors closer to the nurse’s station or centers of activity so the alarms can be better heard. That was actually a root cause in our 2007 column and several other cases we’ve seen (proximity to the nurse’s station or areas where physicians and nurses are busy writing notes or using computers led to workers turning down the volume of the alarms). Second, though we fully endorse use of technology (eg. pagers, messaging apps, etc.) to send alarm alerts to the people who need to respond, don’t assume nothing can go wrong (see our February 9, 2016 Patient Safety Tip of the Week “It was just a matter of time…”).
Our Patient Safety Tips of the Week for July 2, 2013 “Issues in Alarm Management” and August 16, 2016 “How Is Your Alarm Management Initiative Going?” are good places to start to get recommendations on alarm management.
Prior Patient Safety Tips of the Week pertaining to alarm-related issues:
Drew BJ, Califf RM, Funk M, et al. Practice Standards for Electrocardiographic Monitoring in Hospital Settings. An American Heart Association Scientific Statement from the Councils on Cardiovascular Nursing, Clinical Cardiology, and Cardiovascular Disease in the Young: Endorsed by the International Society of Computerized Electrocardiology and the American Association of Critical-Care Nurses. Circulation 2004; 110: 2721-2746
correction January 25, 2005; Circulation 2005; 111: 378
Gatien M, Perry JJ, Stiell IG, et al. A clinical decision rule to identify which chest pain patients can safely be removed from cardiac monitoring in the emergency department. Ann Emerg Med 2007; 50: 136-143
Syed S, Gatien M, Perry JJ, et al. Prospective validation of a clinical decision rule to identify patients presenting to the emergency department with chest pain who can safely be removed from cardiac monitoring. CMAJ 2017; doi: 10.1503/cmaj.160742, published 30 January 2017
Pelczarski KM. Addressing Alarm Problems in the Emergency Department. Patient Safety & Quality Healthcare 2013; May/June 2013
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In our March 2016 What's New in the Patient Safety World column “Finally…A More Rationale Definition for Sepsis” we welcomed a new consensus definition for sepsis that did away with the SIRS criteria (Singer 2016). For many years we had been on our soapbox about the games played where the patient with pneumonia happily pushing his IV pole up and down the hallway who meets a couple SIRS criteria gets coded as "sepsis", which of course gets a significantly higher reimbursement than pneumonia. The coding games largely skewed the mortality statistics for both “pneumonia” and “sepsis”. So it was with great enthusiasm that we welcomed the new definition that excluded the SIRS criteria.
But the usefulness of this new definition still needed validation in clinical settings. That validation has now come from 2 studies in several settings. Both studies looked at the ability of the Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score and the quick SOFA (qSOFA) to predict mortality (see our March 2016 What's New in the Patient Safety World column “Finally…A More Rationale Definition for Sepsis” for details of the new definitions). One validation study was done retrospectively in the ICU setting, the other prospectively in the emergency department setting.
Freund and colleagues found that among patients presenting to the emergency department with suspected infection, the use of qSOFA resulted in greater prognostic accuracy for in-hospital mortality than did either SIRS or severe sepsis (Freund 2017). These findings provide support for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria as a predictive tool, at least in the emergency department setting. The qSOFA in that setting was as good as the full SOFA in predicting mortality. Those patients with a qSOFA score of 2 or more had an in-hospital mortality rate of 24% whereas those with qSOFA scores <2 had a 3% mortality. Moreover, the addition of serum lactate did not further enhance the predictive value.
The SOFA score also does well at predicting mortality in ICU patients with sepsis but the shorter qSOFA may not fare as well in ICU patients. Raith and colleagues found that among adults with suspected infection admitted to an ICU, an increase in SOFA score of 2 or more had greater prognostic accuracy for in-hospital mortality than SIRS criteria or the qSOFA score (Raith 2017). In that study another more complex tool, the Logistic Organ Dysfunction System, also predicted ICU patient mortality better than the qSOFA. These findings suggest that SIRS criteria and qSOFA have limited utility for predicting mortality in an ICU setting. Note, though, that the qSOFA fared as well or better than Logistic Organ Dysfunction System or the full SOFA in sepsis patients not in the ICU.
In the editorial accompanying these two studies, Lamontagne and colleagues (Lamontagne 2017) stress that early identification of sepsis is still key and that, until future rapid diagnostic tests for sepsis are developed, the qSOFA is a simple tool that appears to be useful.
The Surviving Sepsis Campaign promptly responded to the new definition(s) in March 2016, noting that the implementation of the new definitions and related coding changes would take time for hospitals but reiterating that the new definitions do not change the primary focus of early sepsis identification and initiation of timely treatment (response March 2016).
Howell and colleagues also recently provided a summary of the updated guidelines for managing sepsis (Howell 2017). The highlights include:
There were also recommendations regarding mechanical ventilation parameters for patients with sepsis-related ARDS and a general statement that hospitals and health systems should implement formal programs to improve sepsis care that include sepsis screening. The full updated guideline will be in the March 2017 issue of Critical Care Medicine and is now available online (Rhodes 2017).
Time is of the essence in management of sepsis. We still need to focus on early recognition, timely antibiotics and adequate fluid resuscitation to reduce morbidity and mortality from “sepsis”. It does appear that the new definitions are steps in the right direction and will help us better manage sepsis going forward.
Our other columns on sepsis:
Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016; 315(8): 801-810
Freund Y, Lemachatti N, Krastinova E, et al. for the French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality among Patients with Suspected Infection Presenting to the Emergency Department. JAMA 2017; 317(3): 301-308
Raith EP, Udy AA, Bailey M, et al. Prognostic Accuracy of the SOFA Score, SIRS Criteria, and qSOFA Score for In-Hospital Mortality among Adults with Suspected Infection Admitted to the Intensive Care Unit. JAMA 2017; 317(3): 290-300
Lamontagne F, Harrison DA, Rowan KM. qSOFA for Identifying Sepsis among Patients with Infection. JAMA 2017; 317(3): 267-268
Surviving Sepsis Campaign website.
Surviving Sepsis Campaign. Surviving Sepsis Campaign Responds to Sepsis-3. March 1, 2016
Howell MD, Davis AM. Management of Sepsis and Septic Shock. JAMA 2017; Published online January 19, 2017.
Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Critical Care Medicine 2017; 45(3): 1-67 Published-Ahead-of-Print Post Author Corrections: January 17, 2017
We’re always looking for good tools we can use when we are doing adult learning sessions on patient safety for patients and families. Recently we came across several useful tools from the Manitoba Institute of Patient Safety. Their S.A.F.E. Toolkit – Self Advocacy for Everyone has available both the toolkit and a guide for leaders of structured sessions on the toolkit.
Topics in the toolkit are:
The Leader’s Guide, in particular, has many useful practical tips on how to prepare for your sessions, including checklists to help in such preparation. It includes discussion of timeframes, ground rules, presentation techniques, and even has sample evaluation forms.
The handouts for patients are excellent and comprehensive. Each helps them prepare for their various meetings with members of the healthcare team and provides them with great lists of the questions they (and their advocate) should ask. For example, the one on preparing for surgery has sections on informed consent and deciding whether to undergo surgery, pre-op testing, who will be doing the surgery and providing anesthesia, anesthesia options, preparing for the surgery, what to expect on the day of surgery, what to expect postoperatively, etc. It even has questions to ask if procedures are to be performed in the office.
The section on patient advocates is excellent, describing not only how to choose an advocate but also discussing questions the advocate might ask, access the advocate might have to your medical records, differences between an advocate and a health care proxy, etc. It even provides a sample “My Patient Advocate Agreement”.
While some of the materials are tailored for the Canadian healthcare system(s), they are easily adaptable to those in other countries.
If your healthcare organization offers such educational sessions on patient safety for your patients and their families (as you should!), you’ll find the resources from the Manitoba Institute of Patient Safety very useful.
Manitoba Institute of Patient Safety. S.A.F.E. Toolkit – Self Advocacy for Everyone.
Given the recent holiday shopping season, most of you are familiar with the acronym “BOGO” (Buy One, Get One). It turns out that with critical adverse events, if you have one on a med-surg unit you are also more likely to get another one!
Researchers at the University of Chicago analyzed data from 13 med-surg wards where rapid response teams were used and looked at cardiac arrests and urgent transfers to ICU’s (Volchenboum 2016). They found that in the 6-hour window following a cardiac arrest or urgent transfer to ICU, the likelihood of a second similar event increased 18%. And if 2 events occurred the likelihood of a third event on that ward increased 53%. These results remained statistically significant when the time window was changed to 3 hours or 12 hours after the first event.
The authors explained the findings by likely diversion of resources to critically ill patients, resulting in less attention to other patients on the ward. Anyone who has observed all the events taking place on a ward when a patient has a cardiac arrest or other critical event would not be surprised that less attention gets paid to other patients on the ward. But this is the first time, to our knowledge, that anyone has formally quantified this phenomenon.
The authors stress that although the absolute increased risk was small, these events were associated with high morbidity and mortality.
We don’t know what the best solution for this issue is. Obviously, key personnel from the ward are needed to work with the Rapid Response Team (or equivalent group of people responding to a critical event) but there probably should always be clear designation of someone to maintain surveillance over the remaining patients on the ward. And that should be an element covered in your training for Rapid Response Teams.
Our other columns on rapid response teams:
Volchenboum SL, Mayampurath A, Göksu-Gürsoy G, et al. Association between In-Hospital Critical Illness Events and Outcomes in Patients on the Same Ward (Research Letter). JAMA 2016; Published online December 27, 2016
The FDA has just approved another long-acting opioid (FDA 2017). So we’ll take this opportunity to repeat our warnings and concerns about the use of such drugs. For quite some time now we have highlighted the dangers of long-acting and/or extended-release opioids (see our Patient Safety Tips of the Week for June 28, 2011 “Long-Acting and Extended-Release Opioid Dangers”, July 24, 2012 “FDA and Extended-Release/Long-Acting Opioids” and February 24, 2015 “More Risks with Long-Acting Opioids”).
The newly approved drug, Arymo ER, is an extended-release tablet formulation of morphine sulfate, designed with properties intended to deter abuse based on its physicochemical properties. The proposed indication is the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. It is unique in that it is formulated to give it physicochemical properties expected to make abuse by injection difficult. Apparently the manufacturer had hoped to be allowed to claim the drug deters abuse by snorting or chewing it but the FDA approval did not allow that claim.
One of the elements of the FDA Opioids Action Plan is to expand access to abuse-deterrent formulations to discourage abuse. That is essentially developing formulations that abusers cannot manipulate and use the opioid for intravenous, intranasal, or oral abuse.
But our concerns about the safety of long-acting or extended-release opioid formulations extend well beyond the issue of manipulating the product for abuse. Such preparations have other dangers (well described in our Patient Safety Tips of the Week for June 28, 2011 “Long-Acting and Extended-Release Opioid Dangers”, July 24, 2012 “FDA and Extended-Release/Long-Acting Opioids” and February 24, 2015 “More Risks with Long-Acting Opioids”).
First and foremost is that these long-acting and extended-release opioid 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.
A second significant factor related to the association between long-acting opioids and overdoses is dosage equipotency. The amount of morphine equivalents in these preparations is typically higher than that found in most short-acting formulations and many prescribers are not appreciative of this. Of course, the issue of dose is not unique to the long-acting opioids. We’ve highlighted the same problem with HYDROmorphone in our September 21, 2010 Patient Safety Tip of the Week “Dilaudid Dangers” and the other columns on HYDROmorphone safety issues listed below. It is also problematic that when switching from short-acting opioids to long-acting or extended-release opioids it is very common to see misunderstandings of the relative potencies of the various opiate preparations.
We’ve also seen patients develop delayed-onset coma after attempting suicide. If the specific formulation they took is unknown, they may be evaluated in an ER prior to admission to a behavioral health unit, at which time they lack clinical signs of opioid intoxication and may have very low toxicology levels. They are given “medical clearance” and admitted to the behavioral health unit. Overnight they get further release of the opioid into their bloodstream and the following morning they may be comatose.
Another important issue for these long-acting and extended release opioids is the phenomenon of re-narcotization. The effect of the reversal agent naloxone may wear off long before the effect of the opioid wears off, raising the danger of recurrence of respiratory depression.
We’ve also seen rare cases in which patients on these long-acting opioid formulations have developed acute opioid withdrawal symptoms following naloxone injections.
Note that long-acting opioid formulations (particularly those in transdermal patches) are also now frequent causes of accidental overdoses, including those for whom they were not prescribed such as children and pets (see our September 13, 2011 Patient Safety Tip of the Week “Do You Use Fentanyl Transdermal Patches Safely?” and our May 2012 What’s New in the Patient Safety World column “Another Fentanyl Patch Warning from FDA”).
So even though we appreciate the FDA’s vision of abuse-proof formulations, we are concerned about the ever increasing availability of long-acting or extended-release opioid formulations. Ironically, the following quote from the FDA briefing document (FDA 2016) for the advisory committee meeting that evaluated the new opioid formulation says a lot about the siloed nature of our healthcare system: “There has been much discussion at recent advisory committee meetings about whether any new extended-release opioid analgesics are necessary or should be approved. As long as a product meets the regulatory standards for approval, whether or not there is need for a new version of an opioid is not a criterion for not approving the product.”
And as if that were not enough, as we went to post this column we received word the FDA (FDA 2017b) has just approved yet another extended-release opioid formulation: Vantrela ER (hydrocodone bitartrate)! FDA documents (FDA 2017c) note that “the physical and chemical properties of Vantrela ER are expected to make intravenous (injection) abuse difficult and are expected to reduce, but not eliminate, abuse by nasal and oral routes. However, abuse of Vantrela ER by these routes is still possible.”
Our prior articles pertaining to long-acting and/or extended release preparations of opioids:
Our prior columns on patient safety issues related to Dilaudid/HYDROmorphone:
FDA (US Food & Drug Administration). Impact of Exclusivity on Approval of Arymo ER. FDA 2017; January 9, 2017
FDA (US Food & Drug Administration). Fact Sheet – FDA Opioids Action Plan. Accessed January 23, 2017
FDA (US Food & Drug Administration). FDA Briefing Document. Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee. August 4, 2016
FDA (US Food & Drug Administration). Approval letter for Vantrela ER (hydrocodone bitartrate) extended-release tablets. January 19, 2017
FDA (US Food & Drug Administration). Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse. January 17, 2017
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