Healthcare Consulting Services
April 2, 2013
Absconding from Behavioral Health Services
We’ve participated in several root cause analyses (RCA’s) pertaining to patient absconds or elopements from behavioral health units. One question we always ask is “Is there a validated abscond risk assessment tool?” While behavioral health has risk assessment tools for suicide, falls, substance abuse and others, we have yet to find a risk assessment tool for absconding.
While most patients who abscond from behavioral health units return without any adverse consequences, some may commit suicide, others may commit violent acts, and others may be the victims of violent acts. In addition, absconding may lead to delays in treatment and even have economic consequences (Muir-Cochrane 2008). Patients may be vulnerable if they are drowsy from medications or may miss medication doses and there are also emotional responses felt by staff when patients abscond (Muir-Cochrane 2012a). Patient absconds may also reflect poorly on the hospital’s reputation in the community. So it is important to understand who is at high risk for absconding (note that we will use the terms abscond and elopement interchangeably in this column) and what circumstances may lead to absconding so that we might takes steps to minimize the risks.
A new review (Brumbles 2013) examines the reasons for patient elopement, how they do it, and what might be done to prevent it. The authors rely heavily on previous work done by Dr. Len Bowers and colleagues a decade ago (Bowers 1999a, Bowers 1999b, Bowers 1999c) and a previous excellent review done by Muir-Cochrane and Mosel (Muir-Cochrane 2008). They note that patient level factors are important but that environmental and situational factors are equally important. The review provides a table of reasons patients give for eloping.
Early studies indicated that those who abscond are often young, male, single and from a disadvantaged group. But the environment is important, too. Some patients are simply bored in the hospital and don’t have enough activities. Others feel confined. But a big factor is how the patient perceives safety of the unit. Patients may feel intimidated by other patients or even by staff. One study (Muir-Cochrane 2012b) found that the perception of the psychiatric unit as an unsafe place by patients increased the probability of absconding. The perception of safety was a complex interaction of physical, social, individual and symbolic aspects of the unit. Familiarity with the unit, comfortable environment, formed therapeutic relationship with staff, and positive experiences with other patients helped develop a perception that the unit was safe, reducing risk of absconding.
Other patients feel they need to look after their belongings at home or have responsibilities to family or others at home and abscond to attend to these.
Patients with dual diagnoses may have substance abuse desires, physiological (withdrawal) or psychological and may abscond because they feel these needs are not being attended to.
One potential risk factor we found to be glaringly absent in the literature is smoking. Due to Joint Commission and other regulatory reasons (as well as health reasons) hospitals today are tobacco-free. That includes the behavioral health units in most hospitals. In our December 2012 What’s New in the Patient Safety World column “Just Went to Have a Smoke” we noted a study (Regan 2012) showing that 18.4% of general hospital patients who smoke will smoke at some time during their inpatient hospitalization. Rates of smoking are 70% higher among people with mental illness, with 36 percent of adults with a mental illness being cigarette smokers, compared with only 21 percent of adults who do not have a mental illness (CDC 2013). So it shouldn’t be surprising to see behavioral health patients leave the unit or the hospital to smoke. Hospitals usually do a good job of identifying smokers on admission and offering them nicotine replacement products and counseling on smoking cessation. But it often stops there. Just assessing tobacco cessation issues and offering nicotine replacement therapy and counseling on admission is not enough. It is really incumbent upon hospitals to incorporate continued assessment, perhaps even daily, of tobacco issues into their care plans.
Another review of absconding from a psychiatric hospital in Australia (Mosel 2010) noted an absconding rate of 13.3%. Though males were more likely to abscond the gender difference between absconders did not reach statistical significance. Most absconders were in the age range 20-29 and schizophrenia was the predominant diagnosis. Absconding around the time bad news is to be delivered, such as extension of an involuntary admission, was also noted frequently. About half the absconders had also absconded previously. Of particular interest was that the time of day of absconding had two peaks, between 1900 and 2059 and between 1500 and 1559. These time periods corresponded to nursing handovers or nursing breaks at this hospital. The earlier study by Bowers et al. (Bowers 1999b) had also shown that nursing shift handovers were a favorite time for patients to abscond.
Though some patients abscond when on leave with permission or during planned (supervised) outings, most simply leave via doors on the units. Some leave through doors unintentionally left unlocked. Some use unattended or stolen keys to open doors. Others leave via windows. In an interesting article outlining the pros and cons of locking doors on psychiatric units, Muir-Cochrane and colleagues (Muir-Cochrane 2012a) many patients and visitors noted they felt that if a patient really wanted to get out of a locked ward they could.
An intervention to prevent elopements resulted in a 25% decrease in elopements (Bowers 2003, Bowers 2005). Key components were a host of staff educational materials, posters, and laminated cards with risk factors. These stressed 6 key elements: rule clarity with a sign out/sign in book, identification of those at high risk for absconding, targeted nursing time for those at high risk, careful breaking of bad news, post-incident debriefing, and multi-disciplinary review after 2 elopements. The 25% reduction in absconds was achieved both in the original 5-unit pilot and the larger 15-unit multiple hospital study.
What do you do after an abscond or elopement takes place? As noted in the intervention above, debriefing and review of each case is important. The Brumbles review provides a table with common questions to ask post-event. They are obviously aimed at identifying factors that may have led to the abscond and identify unfulfilled patient needs or interventions that might be important in preventing another abscond. To that we’d add that the debriefing should also address concerns and anxieties that the staff (i.e. the “second victim”) may have.
The literature has wide variation in reporting adverse outcomes of absconds or elopements. The Brumbles review notes rates of suicide as high as 20-30%. However, Bowers et al. (Bowers 1999c) note that many facilities do not report all absconds so that statistics may be biased. In their own study they found 2.4% of patients harmed themselves during absconds, 1.6% harmed others, and the other 96% had benign outcomes. The vast majority actually went home and did typical day-to-day activities. Nevertheless, the potential for suicide or other harm or harm to others is there during absconds and it is important to prevent them. The Bowers group also points out that even when patients return unharmed a considerable amount of staff anxiety has occurred plus a large amount of work on the part of staff and police in many cases. And confidence in the hospital may decline amongst patients, families, and the community.
We hope that some of the learnings from these studies may prove useful to those hospitals having behavioral health units. All would agree that simply locking the doors or using other physical constraints is not enough. It is important to understand why patients abscond and make the behavioral health environment feel safe to the patient. The human interactions are far more important than the physical ones.
Muir-Cochrane E, Mosel KA. Absconding: A review of the literature 1996-2008. Int J Ment Health Nurs 2008; 17(5): 370-378
Muir-Cochrane E, van der Merwe M, Nijman H, Haglund K, Simpson A, Bowers L. Investigation into the acceptability of door locking to staff, patients, and visitors on acute psychiatric wards. Int J Ment Health Nurs 2012; 21(1): 41–49
Brumbles D, Meister A. Psychiatric Elopement: Using Evidence to Examine Causative Factors and Preventive Measures. Archives of Psychiatric Nursing 2013; 27(1) 3-9
Bowers L, Jarrett M, Clark N, et al. Absconding: why patients leave. J Psychiatr Ment Health Nurs 1999; 6(3): 199-205
Bowers L, Jarrett M, Clark N, et al. Absconding: how and when patients leave the ward. J Psychiatr Ment Health Nurs 1999; 6(3): 207-211
Bowers L, Jarrett M, Clark N, et al. Absconding: outcome and risk. J Psychiatr Ment Health Nurs 1999; 6(3): 213-218
Muir-Cochrane E, van der Merwe M, Nijman H, Haglund K, Simpson A, Bowers L. Investigation into the acceptability of door locking to staff, patients, and visitors on acute psychiatric wards. Int J Ment Health Nurs 2012; 21(1): 41–49
Muir-Cochrane E, Oster C, Grotto J, Gerace A, Jones J. The inpatient psychiatric unit as both a safe and unsafe place: Implications for absconding. Int J Ment Health Nurs 2012; Article first published online : 25 SEP 2012
Regan S, Viana JC, Reyen M, Rigotti NA. Prevalence and Predictors of Smoking by Inpatients During a Hospital Stay. Arch Intern Med 2012; ():1-5, Published online ahead of print November 5, 2012
CDC. Vital Signs: Current Cigarette Smoking Among Adults Aged ≥18 Years with Mental Illness — United States, 2009–2011. MMWR 2013; 61: 1-7 early release February 5, 2013
Mosel KA, Gerace A, Muir-Cochrane E. Retrospective analysis of absconding behaviour by acute care consumers in one psychiatric hospital campus in Australia
Int J Ment Health Nurs 2010; 19(3): 177–185
Bowers L, Alexander J, Gaskell C. A trail of anti-absconding intervention in acute psychiatry wards. J Psych Ment Health Nurs 2003; 10: 410-416
Bowers L, Simpson A, Alexander J. Real world application of an intervention to reduce absconding. J Psych Ment Health Nurs 2005; 12(5): 598-602
April 9, 2013
Mayo Clinic System
Alerts for QT Interval Prolongation
Torsade de Pointes (see our June 29, 2010 Patient Safety Tip of the Week “Torsade de Pointes: Are Your Patients At Risk?”) is a form of ventricular tachycardia, often fatal, in which the QRS complexes become “twisted” (changing in amplitude and morphology) but is best known for its occurrence in patients with long QT intervals. Though cases of the long QT interval syndrome (LQTS) may be congenital, many are acquired and due to a variety of drugs that we prescribe. The syndrome is more common in females and many have a genetic predisposition. And there are a number of reasons why this syndrome is more likely to both occur and result in death in hospitalized patients. Hospitalized patients have a whole host of other factors that may help precipitate malignant arrhythmias in vulnerable patients. They tend to have underlying heart disease, electrolyte abnormalities (eg. hypokalemia, hypomagnesemia, hypocalcemia), renal or hepatic impairment, and bradycardia, all of which may be precipitating factors. More importantly they may have the sorts of conditions for which we prescribe the drugs that are primarily responsible for prolonging the QT interval (eg. haloperidol, antiarrhythmic agents, etc.). And many of those drugs are given intravenously and in high doses in the hospital as compared to the outpatient arena. Rapid intravenous infusion of such drugs may be more likely to precipitate Torsade de Pointes than slow infusion.
In our Patient Safety Tips of the Week for June 29, 2010 “Torsade de Pointes: Are Your Patients At Risk?” and February 5, 2013 “Antidepressants and QT Interval Prolongation” we recommended development and implementation of CPOE tools and decision support rules and surveillance to generate reminders to appropriate staff regarding QTc (corrected QT interval) prolongation. Now the Mayo Clinic has reported its experience with implementation of just such a system (Haugaa 2013). In addition, they developed a useful scoring tool, the “pro-QTc score” to predict which patients are at risk of increased mortality with prolonged QTc intervals.
There are two key factors to consider that contribute to patients developing prolonged QTc intervals and torsade de pointes or other fatal arrhythmias:
1) Lack of awareness of the risk
2) No one could possibly recall by memory all the drugs that prolong the QT interval
To the first point, the risk for torsade de pointes is generally underappreciated. Cardiologists are more likely to be attuned to the risks for a number of reasons. They are always thinking about potential arrhythmias in the patients they treat. They also generally look at the ECG’s on their own patients and are much more likely to pay attention to the QT interval. On the other hand, physicians on other services usually just look at the ECG report without attending to the QT interval duration. Unfortunately, many of the risk factors (especially the potentially modifiable ones) are seen in patients on services other than cardiology. Certainly the drugs capable of prolonging the QT interval are seen across all services. Some of those services, such as behavioral health, are less sophisticated from the “medical” standpoint unless they also have a dedicated internist or equivalent following each patient while hospitalized. And many of the electrolyte disturbances predisposing to torsade are also common in acutely and chronically ill patients seen on medical and surgical services.
To the second point, the list of drugs that often prolong the QT interval is now at over 100 drugs. For a full list of drugs that commonly cause prolongation of the QT interval and may lead to Torsade de Pointes, go to the CredibleMeds™ website. That site also has a list of drugs that prolong the QT interval and might possibly cause Torsade de Pointes and another list of drugs that have conditional risk (eg. only when combined with other drugs). Some drugs (eg. cisapride/Propulsid, a drug formerly used to promote GI motility) have actually been withdrawn from the market because of serious cardiac side effects, including prolongation of the QT interval and torsade de pointes.
In our June 29, 2010 Patient Safety Tip of the Week “Torsade de Pointes: Are Your Patients At Risk?” we referenced the 2010 AHA/ACCF statement on Torsade de Pointes (Drew et al 2010) which called for increased attention in early identification of patients with prolonged QT intervals who are at risk for torsade de pointes. So in November 2010 the Mayo Clinic developed and implemented a system-wide QT alert system. With some variation based on factors such as heart rate, a corrected QT interval (QTc) 500 msec or greater would trigger a notification alert to the ordering physician as a “semi-urgent finding” with a link to a Mayo website with guidance on management of such cases.
They analyzed over 86,000 ECG’s in over 52,000 patients and sent alerts in 2% of cases. For 470 patients who had an isolated QTc of 500 msec or greater all-cause mortality was 19%, compared to 5% in patients with QTc intervals less than 500 msec. For the population as a whole the QTc was a significant predictor of mortality. For each 10 msec increment in QTc there as a 13% increase in mortality, independent of age and sex. Interestingly, mortality rates were higher in patients with noncardiac diagnoses.
The pro-QTc score included the following: female sex, QT-affecting clinical diagnoses and conditions, QT-prolonging electrolyte disturbances, and QT-prolonging medications (1 point given for each condition or drug). 58% of the 470 patients with isolated QTc of 500 msec or greater had at least one diagnosis associated with QT prolongation and, if female sex were included as a risk factor 99% had at least one risk factor. 53% of these patients had either hypokalemia, hypomagnesemia or hypocalcemia. And 66% of these patients were on a medication known to prolong the QT interval (antidepressants were the most common drugs at 27%, followed by antiarrhythmics at 20% and antibiotics/antifungals at 20%). The mean pro-QTc score for these patients as a whole was 3.1.
The pro-QTc score was a significant predictor of death and did so in a “dose-dependent” manner (i.e. each one-point increment in the pro-QTc score further increased mortality by a factor of 17%). A pro-QTc score of 4 or greater predicted mortality with a hazard ratio of 1.72. On multivariable analysis only the number of QT-prolonging medications and electrolyte abnormalities were significant independent predictors of death. They note that if a patient had a QTc interval of 500 msec or longer and there were at least 4 QT-prolonging medications or QT-prolonging electrolyte disturbances, the mortality was 40%.
The authors describe a typical “perfect storm”: a patient receiving an antidepressant is treated for an infection with an antibiotic having QT-prolonging potential and may have concomitant electrolyte abnormalities.
There are limitations to the study. It was a retrospective study, not a randomized controlled study. A substantial number of patients with congenital long-QT syndrome were included (because the Mayo Clinic is a referral center for such patients) but analysis excluding these patients did not alter their main findings. The authors of the Mayo study and the accompanying editorial (Mizusawa 2013) point out that the cause of death in patients was not known and it is likely that many did not die arrhythmic deaths. They also note that the pro-QTc score gave equal weight to all factors and that future modifications of that score might need to consider giving different weights to different factors (an example given is that the risk of torsade varies considerably for different drugs from the list of potentially QT-prolonging drugs). They also note that what the physicians did when they received an alert was not captured.
Overall, this is really a great contribution and shows that it is feasible to utilize readily available data to identify patients who may be at risk for torsade. We’d ultimately like to see integration of the QTc measurement and a scoring system like the pro-QTc scoring system into the CPOE system. Though we are always mindful of alert fatigue, it would be most valuable at the time of order entry to alert the physician that a drug he/she is about to order will likely further increase the QTc interval and put the patient at further risk of torsade.
Most importantly, it demonstrates that the major risk factors identified are potentially modifiable. Since the electrolyte disturbances may be corrected and medications may be switched there is significant opportunity to reduce the risk of torsade de pointes when prolonged QTc intervals are recognized early.
Also, since our last column on QT interval prolongation and the risk of torsade de pointes the FDA has issued a safety alert regarding QT interval prolongation and arrhythmia risk for azithromycin (FDA 2013). Though it has long been known that azithromycin is one of the drugs that can prolong the QT interval (we noted it in our June 29, 2010 Patient Safety Tip of the Week “Torsade de Pointes: Are Your Patients At Risk?”) the FDA has looked at new information and determined that this risk is significant enough for azithromycin to issue the alert and update the drug labeling to strengthen the Warnings and Precautions section. Much of that new information came from a study published in the New England Journal of Medicine a year ago (Ray 2012). That study demonstrated an increase in cardiovascular deaths and all-cause deaths in patients treated with a 5-day course of azithromycin compared to treatement with amoxicillin, ciprofloxacin, or no drug. Moreover, the duration of the increased risk corresponded to the duration of the azithromycin therapy. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin.
During 5 days of azithromycin therapy there was a small absolute increase in cardiovascular deaths with 47 additional cardiovascular deaths per 1 million courses of azithromycin therapy compared to amoxicillin therapy. For patients in the highest decile of baseline risk of cardiovascular disease there were 245 additional cardiovascular deaths per 1 million courses.
However, the FDA alert appropriately recommends consideration of the potential benefits and risks of antibiotic choice given the context of the situation and also consideration that many of the alternative antibiotics may also prolong the QT interval.
Our June 29, 2010 Patient Safety Tip of the Week “Torsade de Pointes: Are Your Patients At Risk?” also discussed not only inpatient issues but also issues related to QTc prolongation and the emergency department, psychiatry, anesthesia, and surgery and the nuances of measuring the QT interval and the QTc (corrected QT). In all settings it is important to consider not only the potential effect of various drugs but also underlying conditions and other contributing factors such as electrolyte disturbances. We had recommendations on what your hospital facilities should be doing:
To those we obviously now recommend considering a system of alerts similar to that in the Mayo Clinic study and considering using a scoring system like the pro-QTc score.
Since the majority of the risk factors here are potentially modifiable or avoidable it is imperative that we put into place systems that will help early identification of patients at risk.
Haugaa KH, Bos JM, Tarrell RF, et al. Institution-Wide QT Alert System Identifies Patients With a High Risk of Mortality. Mayo Clin Proc 2013; 88(4): 315-325
Drew BJ, Ackerman MJ, Funk M on behalf of the American Heart Association Acute Cardiac Care Committee of the Council on Clinical Cardiology, the Council on Cardiovascular Nursing, and the American College of Cardiology Foundation
Prevention of Torsade de Pointes in Hospital Settings: A Scientific Statement From the American Heart Association and the American College of Cardiology Foundation
Circulation 2010;121;1047-1060; originally published online Feb 8, 2010
Mizusawa Y, Wilde AAM. QT Prolongation and Mortality in Hospital Settings: Identifying Patients at High Risk. Mayo Clin Proc 2013; 88(4): 309-311
FDA. FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms. Safety Announcement. March 12, 2013
Ray WA, Murray KT, Hall K, et al. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012; 366: 1881-1890
April 16, 2013
Distracted While Texting
Long-time readers of our column remember that we often use aviation analogies to illustrate patient safety issues and also that we have often been critical of the medical helicopter industry. Today’s column allows us to do both based on a recent NTSB investigation report on a 2011 medical helicopter accident (NTSB April 9, 2013).
The 2011 accident involved the crash of a medical helicopter that was transporting a patient from a rural community hospital to a larger hospital. Four people (the patient, a nurse, a flight medic, and the pilot) were killed in the crash. After the initial takeoff of the helicopter from its home base the pilot recognized the helicopter did not have enough fuel. After picking up the patient at the community hospital, the pilot decided to continue flying and attempt to land at an alternate site to refuel. The crash occurred about one mile short of that site when the helicopter ran out of fuel and the pilot failed to make the emergency maneuvers that would have allowed the helicopter to glide to a safe landing. The investigation revealed that the pilot had not done the pre-flight evaluation that is routinely performed before such flights, which would likely have identified the fuel shortage before takeoff. The NTSB Board identified as a root cause likely distraction of the pilot due to frequent text messaging throughout his shift and even in-flight. They felt that such very likely contributed to the failure to perform the pre-flight checklist and perhaps also to the failure to perform the emergency maneuvers when the fuel ran out.
The texts sent and received were apparently of a personal nature, unrelated to the pilot’s responsibilities with the helicopter transport company. NTSB notes that these occurred during a period in which the helicopter was being repaired for return to service, during flight, and even during a phone call to his flight communications specialist while he was making a decision about whether to continue the flight. Though they found no evidence of texting at the time of engine failure, they wondered whether the distractions related to the issues involved in the texting might have interfered with his ability to react quickly to the rapidly evolving events.
NTSB also considered it likely that fatigue may have played a role since this occurred near the end of his shift and his sleep the prior night may have been restricted.
They note that the pilot missed three opportunities to detect the condition: 1) before departing on the first leg of the mission as a result of his inadequate preflight inspection, 2) before takeoff by failing to properly complete the before-takeoff confirmation checklist, and 3) after takeoff when he erroneously reported the fuel level. They also felt that self-induced pressure likely caused the pilot to fixate on his intended refueling point and continue the flight rather than make a precautionary landing as the fuel gauge indication approached zero.
NTSB also found inadequate training on how to recover from the sort of malfunction that occurs on fuel exhaustion (i.e. how to successfully perform an “autorotation”).
But, just as we see in medical incidents with adverse consequences, a series of events came together to contribute to this unfortunate accident (see the multiple documents included in the NTSB docket for this accident).
The pilot on the previous shift did sign out to the pilot involved in the accident. He informed the incoming pilot that the helicopter needed servicing and would be in need of refueling after servicing. There apparently was a second helicopter that would be used in the event an emergency transport call came in prior to that servicing being completed. The servicing, however, was completed on the first helicopter (which was the one involved in the actual crash). The helicopter mechanic completed the maintenance logbook entries required to return the helicopter to service but the pilot did not initial the “conform your aircraft” entries as required before flight. The pilot also did not sign the Daily Flight Log/load manifest for after the helicopter was put back into service. The requirement is that the pilot record the preflight/airworthiness check by signing the appropriate section of the Daily Flight Log. The pilot and medical crew transferred the medical gear from standby helicopter back to the actual flight helicopter once it was back in service.
Shortly after takeoff on the first leg of the transport mission the pilot reported to his communications team that he had 2 hours worth of fuel, even though he apparently had never completed the pre-flight checklist. After arrival at the sending hospital he told his communications team that about halfway through the flight he realized he did not have as much fuel as he had reported (the standby helicopter may have had about 2 hours worth of fuel but the fuel level in this helicopter had not been checked). Various options about whether and how to proceed were discussed but the ultimate decision is up to the pilot. After several attempts to locate an airport that had the Jet-A fuel needed for the helicopter, an airport was located about 58 miles away. The pilot indicated he would go to that airport and refuel. When asked whether he would go there first and return to pick up the patient, he indicated he would take the patient and refuel with the patient onboard.
Handoffs may also have played a role. The first conversations about the fuel status occurred with one communications specialist who was going off shift. He did convey the information to the oncoming communications specialist, who handled all further communications. The first communications specialist also went to speak to his supervisor face-to-face to inform him about the situation.
Assumptions also played a role. All the communications people interviewed noted that refueling during a mission was very rare and that refueling with a patient onboard likely even rarer. The supervisor, upon hearing about the possible fuel shortage, noted who would need to be contacted about the situation. Since communications personnel do not make clinical decisions, any question about whether the patient should be onboard for refueling (or could wait for refueling first) would be up to clinical people. However, he noted that the medical director was “on the flight” (?meaning he was in contact with the helicopter personnel) and did not feel he had to call that medical director. He assumed the medical director would address those issues.
As usual, the authority gradient issue also reared its ugly head. Just as in medical incidents with adverse outcomes, someone usually knows that something is wrong but is afraid to speak up or question the authority of others. All the communications specialists and supervisors felt something unusual was happening but all noted that flight decisions are up to the pilot. Interestingly, a good policy at the air transport company was that any flight crew member could cancel any flight any time they felt uncomfortable. And they indicated they had spoken up in cases where, for example, weather conditions were a factor. However, it was apparent in interview with other flight crews that seldom were the other members of the flight crew (nurse or medic) aware of flight operational issues like fuel supply. And staff at the sending hospital said the crew did not mention anything about fuel status. Guidance and advice on the fuel issue could have been available through the company’s Operational Control Center but they were never consulted. Staff noted that the pilot would usually contact the OCC directly or ask the communications specialist to patch him through if the pilot felt assistance was needed.
You’ll recall our “big three” we see in almost every RCA we do on an adverse event with patient harm: communications issues, failure to buck the authority gradient, and failure to heed alarms. We’ve discussed the first two. There likely was also a factor related to alarms. The helicopter did have a low fuel alert light. However, the status of the lighting on the low fuel alert was not known. It was speculated that it may have been on “night mode” which may have rendered it difficult to see during daylight.
Time and monetary pressures are always concerns. Such were not discussed much in the documents. However, apparently this air transport company is the not primary one for that rural hospital but the other one was not available at that time. The helicopter transport industry is very competitive and lucrative (see articles at the end of today’s column) so it is conceivable the pilot may have wanted to demonstrate timely performance. Also, not much was said about day of the week. These events occurred around 5PM on a Friday. We always kidded at our hospitals that typically “all hell broke loose” around 3:30 PM on every Friday. There are lots of staffing issues and availability of services in hospitals and other industries that change for the weekend, often leading to decisions that might be different on another day of the week.
Another good policy at the company was a Just Culture approach. Just about everyone interviewed felt that if the pilot had turned around or delayed to refuel, the company would not have disciplined him but rather would have done an “atta boy”. But that does not mean the pilot may not have put pressures on himself. He might have felt embarrassed that he had left with an inadequate fuel supply. He might have felt he would be denigrated in the minds of others if the flight was delayed even though the Just Culture approach existed. But some of the time pressures may also have been personal. Some of the texts exchanged were about a dinner date to follow the flight.
So can you picture an analogous situation with similar factors contributing to an incident in your hospital? Picture a surgeon who has an emergency case to do on Friday afternoon. He’s busy texting family or friends about their weekend plans that may now have to be altered. The nursing and surgical staff and anesthesiologists are scrambling to see who will start the case (and will they all stay on the case through completion or will they have to switch teams in mid-operation?). A surgical tech mentions to the physician that she thinks they are missing a certain piece of equipment or a specific implant. The surgeon, distracted by his texting or cell phone calls, angrily says “just get me ready to operate”. No pre-op huddle is done. A perfunctory “timeout” is done that verifies the patient, the procedure, and the site are correct but discusses little else about the case. An hour into the procedure the nurse and scrub tech are replaced by new staff. Fifteen minutes later the surgeon asks for that piece of equipment or implant that the first surgical tech was concerned about. They don’t have it. The surgeon decides to proceed anyway and improvises a solution rather than wait for that item to be obtained from a nearby hospital. The patient suffers a complication as a result of the above events and has an unsatisfactory outcome or even death.
Of course, we are simply picking on a surgeon in the above case. The distracted individual in a real case could be an anesthesiologist. Or an ER physician at the end of a shift. Or a PCP in the office. Or any one of a number of providers in various healthcare settings.
The point is that distractions, especially when added to a variety of other latent or active factors, may be paramount in accidents and incidents.
NTSB also pointed out that, although this may have been the first aviation accident where distraction due to electronic devices was an important factor, multiple other transportation accidents have involved texting or other forms of electronic device distractions (NTSB 2012). They do also note a prior aviation incident in which pilots overflew their destination by over 100 miles because they were distracted while doing things on their laptop computers. They state that portable electronic devices that do not directly support the task at hand have no place in vehicles, planes, trains, and vessels. In that communication they cite the literature that shows the cognitive effects of such interactions with electronic devices, rather than the physical interactions, are responsible for the distractions.
Texting has been in the news in many motor vehicle accidents lately. A recent CDC report (Naumann 2013) shows that 68.7% of US adult drivers aged 18-64 years reported they had talked on their cell phone while driving at least once in the past 30 days and 31.2% had read or sent text or e-mail messages while driving at least once in the past 30 days.
About a year ago there was a New York Times article on the potential patient safety issues related to distractions from electronic devices in hospitals (Richtel 2011). It describes things like a neurosurgeon making personal calls on a cell phone via wireless headset during an operation, and a nurse in the OR using an OR computer to check airline prices during an ongoing operation.
The New York Times article quotes an article from the journal Perfusion (Smith 2011) which found that 55 percent of technicians who monitor bypass machines acknowledged to researchers that they had talked on cellphones during heart surgery. Half said they had texted while in surgery. The NYT article also cites an article by anesthesiologist Dr. Peter Papadakos (Papadakos 2011). In that article he quotes an abstract presented at the 2011 annual meeting of the American Society of Anesthesiologists that nurse anesthetists and residents were distracted by something other than patient care in 54% of cases—even when they knew they were being watched! Most of what took their time were pleasure cruises on the Internet (abstract 1726).
Take a look around your healthcare setting some time and see what sort of distractions due to electronic devices are in play.
Then we have our standard complaint about the NTSB root cause analyses in such medical air crashes. Not once do we see the issue of necessity for helicopter transport addressed. Of course, their response will be that such questions are not within their jurisdiction. Technically, they are correct. However, if we do an RCA on a surgical case that had a bad outcome, one of the first questions we always ask it “was the surgery indicated?”. Our previous columns discuss the surprising lack of oversight of the medical air transport industry. Unless there is a local/regional body doing quality assurance on all such transports, no one has any idea of the appropriateness of air transport and whether alternative land ambulance transport might have been as or more appropriate.
Pertaining to the case at hand, Google Maps shows the distance between the two hospitals to be 74 miles and the estimated driving time to be 1 hour and 5 minutes, the route being almost entirely interstate highway. Even if the helicopter had successfully made the trip (62 nautical miles each way), the time elapsed would have been at least the same or longer (from original takeoff to time of crash was roughly 71 minutes and there were still about 7 more miles to go to reach the receiving hospital). Of course, there are other factors to consider which we are not aware of. For example, we don’t know if there were any construction or other delays on that route on that day. We also don’t know whether ground ambulance would have had adequate medical support to accompany the patient on the trip. Though clinical details are lacking in the NTSB reports, apparently the patient was hypotensive so the need for accompanying medical personnel was present. Rural hospitals seldom have extra staff available that they can send on such road trips and many rural ambulance services lack the sort of medically trained personnel needed to accompany a critically ill patient. And we don’t know where the ground ambulance would have been located. Also some ambulance services, particularly those dependent upon volunteers, don’t like long distance transports that are very time consuming.
But the point we have made repeatedly in the past is that hospitals often reflexly call for helicopter transport without recognizing they may actually delay the patient reaching the ultimate destination. We’ve also seen families in rural areas hit with $10,000+ bills for helicopter transport that may not be covered by insurance because of lack of medical necessity.
We’ve done multiple columns pointing out inappropriate use of helicopters (or other air transport) for many medical patients and the dangerous track records of helicopter safety for patients and medical personnel. In our July 8, 2008 Patient Safety Tip of the Week “Medical Helicopter Crashes” and our October 2008 What’s New in the Patient Safety World “More Medical Helicopter Crashes” we discussed the “epidemic” of crashes of helicopters and other medical rescue aircraft in the recent past. We have been very critical that the regulatory agencies involved in oversight of the air medical industry have focused too much on proximate causes and ignored root causes (see our Patient Safety Tips of the Week for February 3, 2009 “NTSB Medical Helicopter Crash Reports: Missing the Big Picture” and September 1, 2009 “The Real Root Causes of Medical Helicopter Crashes” and our November 2010 What’s New in the Patient Safety World column “FAA Safety Guidelines for Medical Helicopters Short-Sighted”). Proposed solutions to these crashes have always focused on proximate causes and recommendations have come out in favor of mandating night vision goggles, terrain warning systems, better weather information, changes in pilot training, etc.
All these solutions ignore some of the most important root causes and failed to ask an important question “Was an air medical evacuation really necessary here or could ground ambulance have been adequate?”. Even the few root cause analyses (RCA’s) we have seen following actual medical helicopter crashes have failed to ask that fundamental question “Was the helicopter transport indicated in the first place?”.
We previously noted a 2006 study done by Dr. Bryan Bledsoe and his colleagues that was a meta-analysis of helicopter transport of trauma patients (Bledsoe 2006). Using several widely-used injury severity or trauma scores, they showed that almost 2/3 of trauma patients brought by helicopter to a trauma center had minor or non-life-threatening injuries and that 25% were discharged from the hospital within 24 hours. Another new study (Delgado 2013) questions the cost-effectiveness of helicopter transport (vs. ground emergency services) for trauma scene transport.
In our March 2012 What’s New in the Patient Safety World column “Helicopter Transport and Stroke” we discussed some relevant issues related to timing and mode of transport of transfers of stroke patients and MI/ACS patients, noting on how transport issues become important
In our November 2010 What’s New in the Patient Safety World column “FAA Safety Guidelines for Medical Helicopters Short-Sighted” we highlighted some questions you should ask before sending your patients (and staff) off on medical helicopter transports.
So you really do need to take a hard look at the types of patient you are sending out to tertiary centers, make sure that they get the best evidence-based treatments available within a realistic timeframe, and make good decisions about mode of transport for those that do need transfer.
Our prior columns dealing with medical helicopter issues:
July 8, 2008 “Medical Helicopter Crashes”
October 2008 “More Medical Helicopter Crashes”
February 3, 2009 “NTSB Medical Helicopter Crash Reports: Missing the Big Picture”
September 1, 2009 “The Real Root Causes of Medical Helicopter Crashes”
November 2010 “FAA Safety Guidelines for Medical Helicopters Short-Sighted”
March 2012 “Helicopter Transport and Stroke”
NTSB (National Transportation Safety Board). Public Meeting of April 9, 2013
(Information subject to editing). Medical Helicopter Operated by LifeNet Crash
Near Midwest National Airport Mosby, Missouri, August 26, 2011 NTSB/AAR-13/02
NTSB (National Transportation Safety Board). Docket Table of Contents. Accident Investigation CEN11FA599. Medical Helicopter Crash. Date of occurrence: August 26, 2011 near Mosby, Missouri
NTSB. NTSB Most Wanted List. Eliminate Distraction in Transportation. Modified December 11, 2012
Naumann RB, Dellinger AM. Mobile Device Use While Driving. United States and Seven European Countries 2011. MMWR 2013; 62(10): 177-182
Richtel M. As Doctors Use More Devices, Potential for Distraction Grows.,New York Times, December 14, 2011
Papadakos PJ. Electronic Distraction: An Unmeasured Variable in Modern Medicine. Anesthesiology News 2011; 37:11 November 2011
Smith T, Darling E, Searles B. 2010 Survey on cell phone use while performing cardiopulmonary bypass. Perfusion 2011; 26(5): 375-380
Papadakos PJ. Electronic Distraction: An Unmeasured Variable in Modern Medicine. Anesthesiology News 2011; 37:11 November 2011
Bledsoe BE. Wesley AK. Eckstein M. Dunn TM. O'Keefe MF. Helicopter scene transport of trauma patients with nonlife-threatening injuries: a meta-analysis. Journal of Trauma-Injury Infection & Critical Care 2006; 60(6): 1257-65 http://www.jtrauma.com/pt/re/jtrauma/abstract.00005373-200606000-00015.htm;jsessionid=LzvDYgJNbkdJpBhDDCFtr3VBPJJ6WwQ1bvdXstQHvMNQ7Lk0Mygl!447927974!181195628!8091!-1?index=1&database=ppvovft&results=1&count=10&searchid=1&nav=search
Delgado MK, Staudenmayer KL, Wang NE, et al. Cost-Effectiveness of Helicopter Versus Ground Emergency Medical Services for Trauma Scene Transport in the United States. Ann Emerg Med 2013; xx: xx (In Press Corrected Proof) April 11, 2013
Print “Distracted While Texting”
April 23, 2013
Plethora of Medication Safety Studies
For the past several months we had been collecting some recently published studies on medication safety to include in our What’s New in the Patient Safety World column. However, there have been so many of them that are clinically relevant that we thought we needed to include them in one of our Patient Safety Tips of the Week where we discuss them in more detail. Hence, today’s column.
A study from the UK (Seden 2012) looked at prescribing errors in admission and discharge prescriptions. One or more errors was found in 43.8% of prescriptions, over half of which were considered significant. They found no significant difference in error rates by level of experience of the prescribing physician. The strongest predictor of error was the number of items per prescription. The risk of error increased 14% for each additional item in the prescription. Medication omission errors accounted for 26.9% of errors, followed by writing errors and dosing errors at 20.7% and 20.6%, respectively. Medication omissions were very common in patients acutely admitted. The authors recommend early use of clinical pharmacists in the medication reconciliation process and better use of IT systems.
IT systems, however, are not the full answer. Another recent study (Linsky 2013) looked at medication discrepancies in the electronic medical record system of ambulatory care patients in the VA system in Boston. They found 60% of patients had at least one medication discrepancy. Prevalence rates of commissions were 36%, omissions 27%, alterations 19%, and duplications 11%. Interestingly, they found an increased number of medications correlated with more commissions and duplications but fewer omissions. The authors conclude that relying on EHR’s alone will not ensure an accurate medication list.
Dose omission incidents may potentially lead to patient harm. A study from ISMP Canada’s reporting database found 159 incidents of patient harm from dose omissions across different hospital settings over a 2.5-year period (ISMP Canada 2013). Most involved mild or moderate harm and there were no cases of severe harm or death. As you might expect, drugs we consider high-alert medications were most frequently involved. Insulin was involved in 18.9% of incidents and heparin in 13.2%. Other drugs frequently involved were potassium chloride, metoprolol, aspirin, HYDROmorphone, metformin, and warfarin. The authors did qualitative analysis of 79 incidents and found several themes:
They provide multiple examples of system-based factors contributing to harmful dose omission incidents, such as delivery of medications to a prior area after a patient had been transferred, misplacement of the MAR, lack of understanding of nomograms, etc. But they also identified several themes of at-risk patient care processes:
When we do an introduction to patient safety during incoming residents’ week for all the new residents in the Buffalo academic consortium of hospitals we especially focus on medication errors. One of the patient safety practices we strongly encourage them to use is including the indication for the medication any time they order a medication. We provide them numerous examples of look-alike sound-alike (LASA) medication errors that might have been prevented had the prescriber included the indication for the medication. Unfortunately, many CPOE systems do not include a field for indication. A recent paper (Wei 2013) showed how a publicly available, computable resource that links medications with their indications as represented by concepts and billing codes might be used to benefit clinical EMR applications. Another recently published study looked at use of indications tied to the patient’s problem list during CPOE (Galanter 2013). Over a 6-year period over 100,000 alerts fired and resulted in 32 intercepted wrong-patient errors (an interception rate of 0.25 per 1000 alerts). They were able to determine that the prescriber had both patient charts open in almost 60% of those instances (see our comments below about the problem of having multiple charts open simultaneously).
Speaking of wrong-patient medication errors, the Pennsylvania Patient Safety Authority (PPSA) has just put out an analysis of 813 such occurrences over a 6-month period from their data base (Yang 2013). Almost 30% were associated with high-alert medications (insulin, opioids, anticoagulants, etc.). Fortunately, few of these errors resulted in patient harm. But such errors occurred in multiple healthcare settings and involved every phase of the medication process, though the majority occurred during the medication administration phase. Inadequate patient identification checks were common contributory factors. Sometimes nurses (incorrectly) relied on the patient or family’s confirmation of the patient’s name to verify identity. In other cases room numbers (which you’ll recall from the Joint Commission NPSG’s should not be used as a patient identifier) were involved or the medications of two patients in a room were confused. Failure to correctly use the MAR was another contributory factor identified. Transcription errors were also noted, such as transcribing an order into the wrong chart or affixing the wrong patient label to an order. Verbal orders were also identified as contributing factors. Prescribing errors were also common, with the prescriber entering the order on the wrong chart or giving verbal orders on the wrong patient. Errors during the dispensing phase included both filling and delivery errors. Errors in the monitoring phase most often related to laboratory values.
The most common contributing factor they identified was the same medication being ordered (but different doses for each of the two patients). This was considered a factor in 6.4% of the events. Verbal orders and similar patient names were considered factors in about 3% each. And 1.4% were related to confusion with a discharged patient (eg. a medication intended for a patient who had previously been in that bed).
The PPSA article offers several risk reduction strategies. Following the Joint Commission NPSG for accurate patient identification (at least 2 identifiers, which are not to include the patient’s room number or location) is an obvious one. So is limited use of verbal orders. Proper storage of medications needs to be addressed (eg. correct labeling of bins, ensuring that medications are removed from beens and ADC’s when patients are discharged, etc.). Empowering the patient and family, encouraging them to question and speak up, are important as well since many such potential errors were intercepted by patients or families.
Technology may be important. Proper use of barcoding systems is important. Similarly, using all the capabilities of automated dispensing cabinets (ADC’s) is important. Transitioning from paper to CPOE is recommended, though they appropriately point out that such errors may occur during CPOE as well (see also our Patient Safety Tips of the Week May 20, 2008 “CPOE Unintended Consequences: Are Wrong Patient Errors More Common?”, June 26, 2012 “Using Patient Photos to Reduce CPOE Errors”, and July 17, 2012 “More on Wrong-Patient CPOE”).
Despite the numerous examples of errors introduced by CPOE, the overall effect of CPOE on medication errors has been beneficial. A recent systematic review and meta-analysis (Radley 2013) estimates that processing a prescription drug order through a CPOE system decreases the likelihood of error on that order by 48% and that, given this effect size and the degree of CPOE adoption and use in hospitals in 2008, an overall 12.5% reduction in medication errors in the US annually. The authors do, however, acknowledge that it remains unknown whether this error reduction results in a reduction in harm to patients or not.
Another recent study demonstrates the value of the Leapfrog CPOE evaluation tool in monitoring and reducing the occurrence of preventable adverse drug events (Leung 2013). A 43% relative reduction in the rate of preventable ADE was predicted for every 5% increase in Leapfrog scores. We previously described use of the Leapfrog tool in our July 27, 2010 Patient Safety Tip of the Week “EMR’s Still Have a Long Way to Go” and our June 2012 What’s New in the Patient Safety World column “Leapfrog CPOE Simulation: Improvement But Still Shortfalls”.
Many of the drugs noted in several of the studies noted above and another recent review of factors associated with preventable adverse events (Beckett 2012) were high-alert medications. These are drugs associated with a high likelihood of patient harm if given incorrectly or omitted incorrectly. So timely is a new ISMP Medication Safety Alert that points out that many hospitals have high-alert medication lists that are ineffective because they don’t have associated risk-reduction strategies in place (ISMP 2013). It has a great list of key strategies for organizations to implement at multiple levels to reduce the risks of harm from drugs on those high-alert medication lists.
One of those recommendations is doing a FMEA (failure mode and effects analysis). A good example of how to do a FMEA related to medications was also recently published (Lago 2012). They did a FMEA on medication prescribing and administration on pediatric wards and found 37 higher-priority potential failure modes and 71 associated causes and effects. So they were able to identify multiple targets for improvement from a safety perspective.
It is important to recognize that medication errors may vary across different settings. For example, in the pediatric study noted above errors in calculating drug doses and concentrations had the highest risk priority numbers (RPN’s). Similarly, in adults there are differences in medication errors between ICU and non-ICU settings (Latif 2013). The authors, reviewing data from the MEDMARX database found ICU medication errors to be more likely associated with patient harm compared to those in non-ICU settings. While errors occurred most often in the administration phase in both settings, administration errors were more frequent in ICU settings. Leading sources of errors identified in the ICU were deficits in both knowledge and performance, procedure or protocol not being followed, communication, and dispensing device errors. Sources in non-ICU settings were similar except that inaccurate or omitted transcription was more frequent than dispensing device errors. The authors ascribe the greater risk of harm in ICU patients to a variety of factors, including patients being older and sicker with more comorbidities, more medications, more potent drugs, more infusions, more necessary dose calculations, and others.
Also, somewhat surprising in an era of disclosure and apology, when medication errors did occur patients and families were apparently seldom informed about them. This was also seen more often in ICU patients.
Another striking finding in the Latif study was that the staff member responsible for the error was informed of the error a third of the time or less. While feedback should be done in a constructive rather than punitive manner in most circumstances, such feedback is critical if we really expect to reduce errors. A recent study providing feedback regarding prescribing errors to prescribers in a NICU demonstrated a significant improvement in narcotic prescribing errors but not in antibiotic prescribing errors (Sullivan 2013). The authors in the NICU study speculate that narcotic prescribing errors were more likely due to “slips” and “lapses” and were more amenable to feedback than antibiotic prescribing errors, which were much more complex. The best part of the Sullivan study, however, is a great description of the barriers encountered and development of the best way to deliver the feedback. They found that delivering the feedback via carefully structured emails that were short, personal, informative and constructive worked best. They were more likely to be read when the message was in the body of the email rather than in an attachment. And the inclusion of a disclaimer reinforcing the non-punitive nature of the feedback was felt to be very important.
Another study (Eijsbroek 2013) from the Netherlands looked at medication related problems occurring in patients that had been in an ICU during a hospitalization. While the overall occurrence of such problems was relatively infrequent, they did identify cases where chronic medications had not been continued and others where medications intended for short-term use had been inadvertently continued. Our August 30, 2011 Patient Safety Tip of the Week “Unintentional Discontinuation of Medications After Hospitalization” discussed a Canadian study (Bell 2011) showing quite similar issues. The Netherlands study attributed the relatively infrequent occurrence of problems to good medication reconciliation in hospital and to use of a followup clinic that specifically addressed medication issues.
Lastly, the issue of dissemination of medication safety alerts arose again. In our February 26, 2013 Patient Safety Tip of the Week “Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?” we focused on the problem of providers not seeing important safety alerts. However, our focus was primarily at the institutional level. Of course, failure to see (or heed) such alerts is just as important at the individual provider level. An abstract just presented at the American Academy of Neurology annual meeting showed just how widespread and significant that problem may be (Bell 2013). The authors surveyed U.S. neurologists on their knowledge of four recently announced safety risks regarding antiepileptic drugs and determined whether they altered patient care as a result. They found approximately 20% of neurologists were not aware of four major drug safety risks. Many others were aware of such alerts but had not altered their practices as a result of those alerts. Though neurologists learned about drug safety risks from many sources only notifications from specialty organizations were associated with an accurate knowledge of safety risks.
Alerts come from multiple authoritative sources (FDA, ISMP, CDC) and are often also noted in resources like Medscape, specialty journals, trade publications, manufacturers and others. But that may actually also be part of the problem. The alerts come from so many sources, are often duplicative, and may be included with many other alerts that are not relevant to all providers. Often when we get an email from the FDA it has alerts on medications, foods, and devices all interspersed. There are often so many that we miss the important ones as we rapidly scroll through the document(s). Having the alerts come through in a filtered manner would obviously be helpful. Neurologists receive drug safety information non-systematically from multiple sources. Most would prefer implementing "a formal warning process via specialty organizations" and emails with updated product insert warnings directed to specialists.
Seden K, Kirkham JJ, Kennedy T, et al. Cross-sectional study of prescribing errors in patients admitted to nine hospitals across North West England. BMJ Open 2013; 3: 1-14 e002036 doi:10.1136/bmjopen-2012-002036
Linsky A, Simon SR. Medication discrepancies in integrated electronic health records. BMJ Qual Saf 2013; 22(2): 103-109 Published Online First: 25 October 2012 doi:10.1136/bmjqs-2012-001301
ISMP Canada. Aggregate Analysis of Dose Omission Incidents Reported as Causing Harm. ISMP Canada Safety Bulletin 2013; 13(2): 1-6 March 27, 2013
Wei W-Q, Cronin RM, Xu H, et al. Development and evaluation of an ensemble resource linking medications to their indications. J Am Med Inform Assoc 2013; Published Online First: 10 April 2013 doi:10.1136/amiajnl-2012-001431
Galanter W, Falck S, Burns M, et al. Indication-based prescribing prevents wrong-patient medication errors in computerized provider order entry (CPOE). J Am Med Inform Assoc 2013; 20(3): 477-481 Published Online First: 9 February 2013 doi:10.1136/amiajnl-2012-001555
Yang A, Grissinger M. Wrong-Patient Medication Errors: An Analysis of Event Reports in Pennsylvania and Strategies for Prevention. Pa Patient Saf Advis 2013 [prepublication]
Radley DC, Wasserman MR, Olsho LEW, et al. Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems. J Am Med Inform Assoc 2013; Published Online First 20 February 2013 doi:10.1136/amiajnl-2012-001241
Leung AA, Keohane C, Lipsitz S, et al. Relationship between medication event rates and the Leapfrog computerized physician order entry evaluation tool. J Am Med Inform Assoc 2013; Published Online First 18 April 2013 doi:10.1136/amiajnl-2012-001549
Beckett RD, Sheehan, AH, Reddan JG. Factors Associated with Reported Preventable Adverse Drug Events: A Retrospective, Case-Control Study. Ann Pharmacother 2012; 46: 634-641; published ahead of print April 17, 2012, doi:10.1345/aph.1Q785
ISMP (Institute for Safe Medication Practices). Your high-alert medication list—Relatively useless without associated risk-reduction strategies. ISMP Medication Safety Alert! Acute Care Edition 2013; April 4, 2013
Lago P, Bizzarri G, Scalzotto F, et al. Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report. BMJ Open 2012; 2:6 Published 18 December 2012 e001249 doi:10.1136/bmjopen-2012-001249
Latif A, Rawaat N, Pustavoitau A, et al. National Study on the Distribution, Causes, and Consequences of Voluntarily Reported Medication Errors Between the ICU and Non-ICU Settings. Crit Care Med. 2013; 41(2): 389-398
Sullivan KM, Suh S, Monk H, Chuo J. Personalised performance feedback reduces narcotic prescription errors in a NICU. BMJ Qual Saf 2013; 22(3): 256-262 Published Online First: 4 October 2012 doi:10.1136/bmjqs-2012-001089
Eijsbroek H, Howell DCJ, Smith F, Shulman R. Medication issues experienced by patients and carers after discharge from the intensive care unit. Journal of Critical Care 2013; 28(1): 46-50
Bell CM, Brener SS, Gunraj N, et al. Association of ICU or Hospital Admission With Unintentional Discontinuation of Medications for Chronic Diseases. JAMA 2011; 306(8): 840-847
Bell S, Matsumoto M, Shaw S, et al. (Abstract) Evaluating U.S. Neurologists' Knowledge of New Anti-Epileptic Drug Safety Risks (S48.005). Neurology February 12, 2013; 80(Meeting Abstracts 1): S48.005
April 30, 2013
Photographic Identification to Prevent Errors
When we first got involved in CPOE implementation back in 2008 we speculated that an unintended consequence might be that wrong-patient errors might actually become more common for a variety of reasons (see our May 20, 2008 Patient Safety Tip of the Week “CPOE Unintended Consequences - Are Wrong Patient Errors More Common?”). We wondered why HIT vendors had not made it easy to incorporate patient photographs into their EHR’s.
In our December 2008 What’s New in the Patient Safety World “Patient Photographs Improve Radiologists’ Performance” we noted a paper presented at the Radiological Society of North America’s annual meeting showing that inclusion of photographs of patients improved accuracy of radiologists’ reports (Turner 2008). Putting a photograph of the patient aside their images on a PACS screen resulted not only in the radiologists feeling more empathy toward the patient but they also identified more incidental findings (the files were chosen because of incidental findings in this randomized study) without taking more time to review the images.
A few weeks ago a study was presented as an abstract at the American Roentgen Ray Society (ARRS) 2013 Annual Meeting (Tridandapani 2013) that demonstrated how integration of patient photos with imaging studies can be used to identify wrong-patient cases. The researchers at Emory University gave 20 pairs of x-rays to reviewers for interpretation and purposely included mismatched pairs in 2-4 cases. They found that radiologists identified the patient mismatch in 12.5% of cases when no photograph was included. But when patient photographs were included they identified the mismatch in 64% of cases. And when radiologists were told to use the photos in rendering their interpretations they identified 94% of mismatches. Including the photographs did not increase the time required for interpretation. In fact, the time was actually shorter when photographs were included (though not statistically significantly so). Nevertheless the researchers speculated that clinical clues provided by the patient photos may have actually made interpretation more efficient (see below).
The same group from Emory recently described in detail the system they had developed for integration of patient photographs with imaging studies (Ramamurthy 2013). The authors describe the system, which is simple, uses readily available technology and software and widely used standards, and is relatively inexpensive. But the biggest value of this paper is the description of the anticipated advantages of such systems. In addition to increasing the detection of mislabeled or mismatched studies, they felt it would actually improve radiologists’ efficiency and throughput. For example, they might need less time looking for anatomical landmarks and also improve diagnostic capabilities. An example they give is the portable chest X-ray on the patient with multiple lines and tubes. With a patient photograph the radiologist might more readily determine what artifacts are due to such external devices.
They also note that facial recognition software capabilities are rapidly improving and such is likely to perform even better than humans at recognizing mismatched studies.
The authors note that the photographs are not used as one of the two identifiers required for patient identification but rather are used to supplement the other identifiers. But they do note that the photos are sometimes helpful in emergency trauma patients in whom the other identifiers may not be readily available. They also address the potential privacy and HIPAA concerns in the article. They also note circumstances where facial recognition may not be possible (eg. trauma patients with significant bandages, etc.). And they note that for the patient’s first imaging study at the facility any comparison photo would have to come from another source, such as the EHR. They also note that the system works better with color monitors.
But they also recognize there could be unintended consequences. They might distract the reader or provide some information that is conflicting relative to the medical images and the readings might become more subjective. (They note that the study we cited above which showed radiologists were more empathetic when photos were included also showed the radiology reports were longer and contained more incidental findings). And they quote a survey of radiologists that found 67% were not in favor of including photographs.
We think this technology is exciting and really has the potential to reduce wrong-patient errors. Any gains in efficiency or accuracy would be bonuses.
Of course, there are multiple other potential applications of patient photographs in promoting patient safety. In our July 28, 2009 Patient Safety Tip of the Week “Wandering, Elopements, and Missing Patients” we briefly mentioned using photographs of patients when broadcasting an alert for a missing patient. We recommend that you include in your IT system a digital photograph of patients you identify as being at risk for wandering and elopement. Many communities, often in conjunction with their local chapter of the Alzheimer Association, have programs where families provide photos of their relatives with Alzheimer’s Disease or other dementia to the local police department to facilitate searches when such individuals go missing.
In our January 12, 2010 Patient Safety Tip of the Week “Patient Photos in Patient Safety” we noted programs that have used patient photographs to reduce the risk of patient misidentification during medication administration (AHRQ Health Care Innovations Exchange). The JPS Health Network in Fort Worth, Texas implemented such a system on its psychiatry units. They first implemented it on adolescent psychiatry in 2000 then, based on success of that program, extended it to their adult psychiatry service in 2006. They noted that this additional method of correct patient identification is especially needed on psychiatry because patients frequently remove their wristband identifications and may be unable or unwilling to respond to questions at the time of medication administration. In the year after implementation on the adult unit, there were no misidentification errors on either unit. Reappearance of misidentification errors a year later led to a reeducation effort and such errors again fell to almost zero.
The AHRQ document nicely describes how JPS went about implementing the program. The resources needed for the program basically amount to a few digital cameras and some staff training. The cameras should be easy-to-use digital cameras. Nurses take a digital photograph of each patient at the time of admission and print one copy for the chart and a second for a 3x5 inch index card that includes the patient label (with patient’s name, date of birth, medical record number, and barcode). That index card then gets clipped to the patient’s MAR (medication administration record). Nurses then use the photograph as a second means of identifying the patient during medication administration (or other nursing activities). The first means of patient identification remains the more standard multiple-identifier method (they use verifying the patient’s name, date of birth and match on the barcode). Other healthcare workers, including physicians and phlebotomists, also use the photographs for patient identification.
On admission, the nurse taking the photograph explains to the patient the reason for the photography (i.e. to avoid patient misidentification) and assures them it will only be used for that purpose. The process is simple and inexpensive and has become a routine part of the admission process on the psychiatry units at JPS.
The American Association for Clinical Chemistry (AACC April 2009) reported some healthcare organizations are attaching patient photos to requisitions for Pap smears or other specimens that are being examined.
Our June 26, 2012 Patient Safety Tip of the Week “Using Patient Photos to Reduce CPOE Errors” highlighted a Children’s Hospital of Colorado study showing their successful implementation of patient photographs to reduce CPOE errors (Hyman 2012). Beginning with a nice review of the literature on patient-note mismatches, they implemented tools to help avoid such mismatches during CPOE. First they modified their CPOE workflow to include a verification screen asking the provider to verify that this is the patient on whom he/she intends to enter orders. They then began taking photographs of patients at admission or registration and including these on the above noted verification screen. They found a dramatic reduction in the number of events of actual ordering on the wrong patient or near misses. And when such events or near misses did occur, it was usually in charts that did not have a photograph of the patient. While they could not separate out the impact of the verification screen from that of the photograph, they felt that the photographs played a large role in reducing the number of orders placed in the records of wrong patients.
They note that, unlike other CPOE alerts that have a high likelihood of being ignored, the presence of the large centrally placed photograph is effective in capturing the attention of the CPOE user. They do note that photographs have limitations, particularly for newborns and when pictures are poorly exposed. And they note that photographs need to be updated at appropriate times.
Patient photographs might also be used on patient identification cards issued by a healthcare system. This might help avoid “medical identify theft” or other fraudulent use of identification. Also, you’d be surprised at how issuing identity cards for your health system fosters loyalty to your system. We recall many years ago when our health system stopped issuing patient cards. The patients complained! They liked having them to carry around. It gave them a measure of security and sense of belonging. So don’t underestimate the potential value of such cards!
But are there downsides to using patient photographs? Though there is a paucity of literature on use of patient photographs for patient safety, we can certainly anticipate there might be unintended consequences. Just like many other examples we have seen, it could happen that photographs of two patients get mixed up. For example, one might anticipate two patients being admitted around the same time. Each would get photographed. It is conceivable that someone might print out both photographs and erroneously transpose them into the charts or IT system. That is one reason you should never do anything intended for more than one patient simultaneously.
And what about those patients (eg. trauma patients) whose faces may not be recognizeable on admission? And all those babies in the nursery look the same to me! And some patients, particularly those with long stays, may have considerable changes in appearance over time. In a FMEA performed on a radiation therapy program (Scorsetti et al 2010) it was found that photos were often not representative of the patient’s appearance at the time of treatment so staff tended not to rely on the photographs. In another FMEA (Skibinski et al 2007) it was found that in those patients with a wristband present and checked, a second form of patient verification (photograph, verification of birthdate, positive response to stated name, etc.) was not checked 30% of the time. So not only is training and reinforcement necessary but some audit function would be appropriate.
One other common scenario where we think having patient photographs may be very important is the multiple applications/multiple windows scenario. Most health systems still do not have full integration of all their HIT systems. For example, you may be viewing the hospital electronic record for most patient data but may be viewing a radiologic image on the separate PACS system. Particularly if you have been looking through records on multiple patients it is easy to lose synchronization between the two applications so that you may be viewing the EHR on one patient and the PACS images of a different patient. We suspect that having patient photographs, rather than simply name and DOB, on every page in both systems would help avoid this mismatch.
Do you use patient photographs in your organization? Do any of you use them during handoffs? Let us know how you use them.
Turner Y, Hadas-Halpern I. The effects of including a patient’s photograph in the radiographic examination. Abstract presented at: annual meeting of the RSNA; December 3, 2008; Chicago, IL (As reported in RSNA press release: Patient Photos Spur Radiologist Empathy and Eye for Detail. December 2 2008)
Tridandapani S, Ramamurthy S, Galgano SJ, Provenzale JM. Increasing Rate of Detection of Wrong-Patient Radiographs: Use of Photographs Obtained at Time of Radiography. American Journal of Roentgenology 2013; 200(4): W345-W352
Ramamurthy S, Bhatti P, Arepalli CD, et al. Integrating Patient Digital Photographs with Medical Imaging Examinations. Journal of Digital Imaging 2013; Published online: 14 February 2013 10.1007/s10278-013-9579-6
AHRQ Health Care. Innovations Exchange. Innovation Profile: Use of Photographs as Second Means of Identifying Patients on Psychiatry Units Virtually Eliminates Medication Errors Related to Misidentification.
AACC. Clinical Laboratory News. April 2009. Patient Safety Focus: Disconnection from Patients and Care Providers. A Latent Error in Pathology and Laboratory Medicine. An Interview with Stephen Raab, MD
Hyman D, Laire M, Redmond D, Kaplan DW. The Use of Patient Pictures and Verification Screens to Reduce Computerized Provider Order Entry Errors. Pediatrics 2012; 130: 1-9 Published online June 4, 2012 (10.1542/peds.2011-2984)
Scorsetti M, Signori C, Lattuada P, Urso G, Bignardi M, Navarria P, Castiglioni S, Mancosu P, Trucco P. Applying failure mode effects and criticality analysis in radiotherapy: Lessons learned and perspectives of enhancement.
Radiother Oncol. 2010 Jan 27. [Epub ahead of print]
Skibinski KA, White BA, Lin LI, et al. Effects of technological interventions on the safety of a medication-use system. Am. J. Health Syst. Pharm., Jan 2007; 64: 90 – 96
May 7, 2013
Drug Errors in the Home
Probably the four most common safety issues in ambulatory care are (1) diagnostic errors (2) medication errors (3) failure to follow up on test results and (4) missed opportunities to prepare patients for hospitalizations. We’ve often discussed diagnostic errors and failure to follow up on test results and done several columns on the changing nature of the pre-surgical evaluation. But what about medication issues?
Our April 12, 2011 Patient Safety Tip of the Week “Medication Issues in the Ambulatory Setting” discussed a wide variety of medication errors and other medication issues occurring in patients being followed in the ambulatory setting. But most of the studies we noted relied upon chart review, patient surveys, or data on hospitalizations and ED visits resulting from medication issues. None though really addressed how often medication errors actually occur in the home.
A new study in a pediatric population should open eyes about how often medication errors occur in the home in all patients, pediatric and adult. Walsh and colleagues (Walsh 2013) used review of medical records and prescription orders but added direct observational methods to determine how often medication errors occurred at home in patients who were followed in 3 pediatric oncology clinics. They found an overall error rate of 70.2 per 100 patients. The error rate with potential to cause harm was 36.3 per 100 patients and actual harm was seen in 3.6 per 100 patients. These error rates are higher than those typically seen in comparable hospitalized patients. Importantly, nonchemotherapy agents were more often involved in errors than chemotherapy agents.
The group had previously done a multisite study that demonstrated high outpatient medication error rates in both children and adults with cancer but children were particularly vulnerable to home medication errors (Walsh 2009). This prior study was a chart review study and did not employ the direct observation methodology used in the more recent study. Hence it likely underreported medication errors. The overall medication error rate was 8.1 per 100 clinic visits and over half had the potential to cause harm. The rate in adults was 7.1 per 100 visits, with 61% having potential to cause harm. In children the rate was 18.8 errors per 100 visits, with 41% having potential to cause harm. However, for children over half the errors that had the potential to cause harm or actually caused harm occurred at home.
So what are the implications of this study for patients other than pediatric oncology patients? Though the current Walsh study was done in a pediatric oncology population and they caution that the results might not be generalizable to other populations, we think that many of their findings are highly likely to apply to adults as well. Below are some of the issues we think are take-home lessons that might apply equally well to all patients.
The number of medications may be important. The children in the current study by Walsh et al. were on a median of 10 medications at home. That is similar to many adult patients with chronic diseases. A prospective cohort study (Gandhi 2003) in ambulatory practices which found 25% of outpatients had adverse drug events, 13% of which were serious, noted the number of medications was significantly associated with adverse events.
A frequent root cause of errors in both Walsh studies was a change in the dose or frequency between the time the medication was first ordered and the day it was administered. For example, a chemotherapy regimen might be ordered at the start of the treatment plan but typically gets altered along the way due to changes in clinical or laboratory parameters. So a label on a medication container may tell the patient (or parent or other caregiver) to take it differently than the physician intends it to be administered that particular day. In fact, one of the suggested potential interventions in the 2009 Walsh paper was simply not writing the orders until the day of administration after all lab data has been reviewed. In adults there are a variety of medications (eg warfarin, insulin, anticonvulsants) where we are frequently making changes to the regimens that will not be reflected on the label. There is also often a disparity between what the physician thinks the patient is taking and what the patient is actually taking. In one study (Schillinger 2005) 50% of patients reported taking warfarin doses that were discordant with what the physician reported, often resulting in either over- or under-anticoagulation.
The parents in the current Walsh study were particularly well educated and 97% scored adequately on a test of health literacy. But health literacy has often been a factor in home medication errors. Moreover, there is often a disparity between parents’ reading abilities and their numerical literacy (also known as numeracy). Parents with low numeracy may be especially prone to make errors in tasks requiring dose measurement or measurement conversions (see our June 2012 What’s New in the Patient Safety World column “Parents' Math Ability Matters”). This highlights the need to address numeracy skills of parents when communicating medication instructions (we suspect the same is likely to apply to adult medication errors as well).
Language may also be a contributing factor to medication errors in the home. One of the earliest studies on the frequency and impact of drug complications in outpatients (Gandhi 2000) found that number of medical problems, failure to explain side effects, and language other than English or Spanish were factors associated with drug complications.
The complexity of the medication regimen is also an important contributory factor. Particularly for pediatric oncology patients many regimens require dose calculations based on weight or body surface area or are altered dependent upon results of white cell counts or other laboratory parameters. Also some drugs are given on very irregular schedules. But adults are also impacted by the complexity of their prescribed regimens. One study (Wolf 2011) gave well-educated volunteers prescriptions for seven drugs and watched them try to figure out how and when to take them all. They could theoretically be consolidated to be taken in 4 dosing sets per day. Yet only 15% were able to consolidate the regimen to 4 times daily or less. Most ended up with regimens taking medications 6 or 7 times daily. Even the instructions “twice daily” and “every 12 hours” resulted in medications being taken at different times. Another study (Choudhry 2011) extended findings in the literature on the negative impact that regimen complexity has on medication adherence.
Drugs that may be prescribed differently for different conditions are also an issue. One of the potentially life-threatening errors in the current Walsh study involved a label on methotrexate to give 8 tablets daily rather than weekly. That error with methotrexate, by the way, is a serious error that we’ve encountered multiple times (see our July 2010 What’s New in the Patient Safety World column “Methotrexate Overdose Due to Prescribing Error”).
The perceived importance of the medications may also be important. In the current Walsh study 2 of the errors resulting in harm had to do with underdosing or failure to fill prescriptions for antacids. Unfortunately, we as providers often do a poor job of emphasizing the importance of certain OTC drugs. Best example is the patient being discharged after an MI. We given them a sheaf of prescriptions for medications and then also say at the end “By the way, take an aspirin daily.” Guess which medication they are most likely to forget!
Handoffs may also be factors in home medication errors. Intervening hospital admissions, emergency department visits, appointments with multiple physicians, and other transitions of care are all opportunities where medication reconciliation may fail. And we are not just talking about provider-to-provider handoffs. Rather handoffs from one parent to another parent or from a parent to another caregiver are also opportunities for miscommunication and consequent errors in the home.
Perhaps a very important contributory factor is lack of feedback about the errors. That applies to both the providers ordering and the parents administering the medications. Most of the errors in the current study were uncovered by direct observation by the study nurse. Neither the prescriber nor the parent would have known about the errors otherwise. We discussed the issue of lack of feedback in recent columns, both in relation to medication errors (April 23, 2013 “Plethora of Medication Safety Studies”) and diagnostic errors (May 2013 “Scope and Consequences of Diagnostic Errors”).
In both Walsh studies, the administration phase was most often associated with medication errors. Most prior studies of ambulatory medication errors (eg. Gandhi 2003, Gurwitz 2003) found problems in the prescribing and monitoring phases were most common. But those studies did not utilize the direct observational methods used in the current Walsh study.
So what are the potential solutions? Most of the articles emphasize patient/parent education and good medication reconciliation. But we all know that the impact of both to date has been suboptimal.
One simple strategy mentioned by Walsh and colleagues (Walsh 2009) was not to write orders for medications until the actual day of administration after all clinical and laboratory parameters have been reviewed. While that may be reasonable for chemotherapy agents, it is not very practical for the vast majority of medications our adult patients are taking at home.
Pharmacist involvement is one potential solution. Quite a few years ago CMS initiated its Medication Therapy Management (MTM) program for Medicare patients. It involved someone (usually a pharmacist or a specially trained nurse) to interview Medicare patients, often in their homes, about their medications and how they were taking them and doing medication reconciliation. Patients were usually chosen based upon their taking a specified number of medications or meeting a specified dollar threshold for spending on medications. We’ve used MTM programs in several other settings (an ACO setting, an Alzhiemer’s Disease assistance program, a managed care organization) and found such to be extremely useful. Whether done by pharmacists or nurses they almost always discover potentially useful changes in the medication regimen that they then take to the provider for potential action. Most often they find therapeutic duplications, medications that were originally begun as temporary prophylaxis but never discontinued (proton pump inhibitors being the biggest offenders), medications meeting Beers’ criteria for potentially inappropriate medication use in older persons, or use of brand medications when an equally effective but less expensive generic formulation is available. Our experience is that almost every such visit identifies an average of two such potential changes. Patients are usually quite happy – they end up with fewer medications and lower copays. Though MTM was likely originally developed with financial goals in mind, its potential impact for quality and patient safety is probably much higher. When we implemented such in an Alzheimer’s disease population many of the recommended medication changes were for medications that were potentially leading to increased confusion or falls. It you look at the costs of potential complications avoided by such programs the cost of program implementation is probably fully recovered. So as we move to new reimbursement systems (ACO’s, global budgets, etc.) more frequent use of such programs makes sense.
Where are the IT solutions? Barcoding has arguably been the most successful patient safety intervention on the inpatient level but has not been adopted in most outpatient settings, let alone the home. But why not? If we can use our iPhones to scan barcodes of products and have them register at the cashier’s station why hasn’t someone figured out how to integrate barcoding with medication administration in the home?
In our October 16, 2012 Patient Safety Tip of the Week “What is the Evidence on Double Checks?” we noted an interesting application of the double check in a homecare setting via televideo monitoring (Bradford 2012). Basically, with a desktop PC and a webcam one can verify the drug name, dose, and gradations on syringes greater than 1 unit with close to 100% accuracy. However, reading expiration dates on vials proved more difficult, with rates of 63%. We suspect that much of the direct observation in the home done in the current Walsh study could be done via such televideo monitoring.
We can’t continue to think we are responsible for our patients only when they come in to our offices and clinics. We need to use a combination of technology and old-fashioned face-to-face visits in the home to help reduce the errors occurring in the home that we are currently not even aware of.
Some of our prior columns on medication errors in other ambulatory settings:
June 12, 2007 “Medication-Related Issues in Ambulatory Surgery”
August 14, 2007 “More Medication-Related Issues in Ambulatory Surgery”
March 24, 2009 “Medication Errors in the OR”
October 16, 2007 “Radiology as a Site at High-Risk for Medication Errors”
January 15, 2008 “Managing Dangerous Medications in the Elderly”
April 2010 “Medication Incidents Related to Cancer Chemotherapy”
September 2010 “Beers List and CPOE”
October 19, 2010 “Optimizing Medications in the Elderly”
April 12, 2011 “Medication Issues in the Ambulatory Setting”
June 2012 “Parents' Math Ability Matters”
Walsh KE, Roblin DW, Weingart SN, et al. Medication Errors in the Home: A Multisite Study of Children With Cancer. Pediatrics 2013; 131: e1405-e1414
Walsh KE, Dodd KS, Seetharaman K, et al. Medication errors among adults and children with cancer in the outpatient setting. J Clin Oncol. 2009; 27(6): 891–896
Gandhi TK, Weingart SN, Borus J, et al. Adverse Drug Events in Ambulatory Care.
N Engl J Med 2003; 348: 1556-1564
Schillinger D, Machtinger E, Wang F, Rodriguez M, Bindman A. Preventing medication errors in ambulatory care: the importance of establishing regimen concordance. In: Henriksen K, Battles J, Lewin DI, Marks E, eds. AHRQ Peer-Reviewed Publication: Advances in Patient Safety: From Research to Implementation, Vol. 2. Rockville, MD; 2005.
Gandhi TK, Burstin HR, Cook EF, et al. Drug complications in outpatients.
J Gen Intern Med. 2000; 15(3): 149-154
Wolf MS, Curtis LM, Waite K, et al. Helping Patients Simplify and Safely Use Complex Prescription Regimens. Arch Intern Med. 2011; 171(4): 300-305
Choudhry NK, Fischer MA, Avorn J, et al. The Implications of Therapeutic Complexity on Adherence to Cardiovascular Medications. Arch Intern Med. 2011; 171(9): 814-822
Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug
events among older persons in the ambulatory setting. JAMA 2003;289:1107-16
Bradford N, Armfield NR, Young J, Smith AC. Feasibility and accuracy of medication checks via Internet video. Journal of Telemedicine & Telecare 2012; 18(3): 128-132
Print “Drug Errors in the Home”
May 14, 2013
Acute Colonic Pseudo-Obstruction (Ogilvie's Syndrome)
We’ve had a longstanding interest in the autonomic nervous system and at one time ran a clinical autonomic assessment service. So we’ve known about Ogilvie’s Syndrome for many years. This condition was first described by Ogilivie in 1948 (Ogilvie 1948) and the term “acute colonic pseudo-obstruction” was later used for it by Dudley et al (Dudley 1958). We’ll refer to it as ACPO in the rest of today’s column. Because Ogilvie reported colonic pseudo-obstruction in 2 patients with retroperitoneal tumors invading the sphlancnic plexus he felt that disordered autonomic function was the underlying pathophysiology. The relationship to the autonomic nervous system, however, remains controversial and the true underlying pathophysiology remains speculative.
But we’re not writing about acute colonic pseudo-obstruction today out of academic interest. We’re writing about it as a patient safety issue, prompted by the deaths of two friends last year who developed colonic pseuo-obstruction after orthopedic surgery. Because the condition typically develops around the anticipated time of discharge after many orthopedic procedures and the early symptoms may be subtle, it is extremely important to recognize the syndrome. Unrecognized or untreated, the condition may lead to colonic ischemia and/or perforation with consequent sepsis and potential death. Mortality rates have been reported to be 40-50% once ischemia or perforation have occurred (De Giorgio 2009).
The condition, of course, is not unique to patients undergoing orthopedic surgery (see below for other associated conditions and/or contributing factors) but it is common enough after orthopedic procedures that any facility performing lots of total joint arthroplasties is likely to encounter cases. One study (Nelson 2006) retrospectively studied over 1100 total hip and knee arthroplasties over a 7 year period and found 18 cases of ACPO postoperatively. The incidence was 1.6% for hips and 1.5% for knees. Another study (Norwood 2005) found an incidence of ACPO of 1.3% in hip replacements, 0.65% in knee replacements, and 1.19% in spinal surgeries. And a more recent study from China (Zhang 2011) found an overall ACPO incidence of 1.4% for total hip or knee arthroplasties. So if you are a high volume joint arthroplasty facility, expect to see a few cases every year. Even if you are a small volume facility you are likely to see a case or two over a several year period.
There are several good reviews of ACPO (Batke 2008, De Giorgio 2009, Nelson 2006, Tenofsky 2000). For those interested in the potential pathophysiological mechanisms involved in ACPO we refer you to reviews by Batke and Capell (Batke 2008), DeGeorgio and Knowles (De Giorgio 2009), and Jain and Vargas (Jain 2012).
Compared to acute mechanical colonic obstruction, the pain in ACPO may be variable. Actually the most common symptom is likely to be abdominal distension, with or without pain. While pain does eventually occur in most patients with ACPO it is usually less severe than that seen with mechanical large bowel obstruction. Severe pain is usually an indication that colonic ischemia or perforation have occurred. Failure to pass stool or flatus is seen in about half of patients with ACPO, though some may have paradoxical diarrhea. Over half also have nausea and vomiting.
The most salient feature on physical examination is usually abdominal distension. Abdominal tenderness, if present at all, tends to be mild and diffuse unless colonic ischemia or perforation have intervened. There is usually tympany to abdominal percussion. Bowel sounds are variable. They may be reduced or absent and one might hear the high-pitched tinkling sounds we associate with bowel obstruction but in cases where the small bowel is functioning normally there may be normal bowel sounds. Significantly, many patients with early ACPO don’t “look sick”, giving rise to a false sense of security. Fever is uncommon unless colonic ischemia or perforation has occurred or it may be due to other concomitant conditions.
Radiologic imaging is critical to diagnosis and differentiation from mechanical large bowel obstruction. Plain films of the abdomen show massive colonic dilatation. While some degree of small bowel dilatation is also commonly seen, the degree of colonic dilatation is disproportionate. This helps distinguish ACPO from the far more common postoperative ileus. The proximal colon is typically more distended than the distal colon and there may be cut-off points or transition zones beyond which the colon appears normal. While some have said such cut-off points favor ACPO over mechanical large bowel obstruction, those are not specific enough to reliably differentiate the two conditions. Therefore additional imaging studies are usually needed. Abdominal CT is said to have both sensitivity and specificity over 90% for ACPO (Batke 2008) and is typically the modality most often used in diagnosis of ACPO. Some have used contrast enemas but barium enemas carry a risk of colonic perforation and water-soluble contrast enemas carry a risk of dehydration. Colonoscopy (see below for the therapeutic use of colonoscopy in ACPO) may also have some diagnostic value but also carries risks of perforation.
Other laboratory tests are done to look for potential contributing factors (eg. fluid and electrolyte disturbances, hypothyroidism, etc.) or complications (eg. leukocytosis in sepsis or colonic ischemia). A high serum lactate level would also suggest either colonic ischemia or sepsis. Appropriate testing for C.diff infection is also indicated in those cases where diarrhea is present.
Management of ACPO is dependent upon multiple factors. Most important is monitoring the patient both clinically and radiologically. The greatest dangers of ACPO are colonic ischemia and colonic perforation. If you remember the Law of LaPlace the wall tension in a tubular structure is greatest where the diameter is greatest. That corresponds in the colon to the cecum and that is where most perforations occur in ACPO. Hence, close monitoring of cecal diameter is a cornerstone of management in ACPO. That can be done by plain radiographs or abdominal CT scanning. One study emphasizing the presence of transitional zones (Choi 2008) had a patient population which probably had mostly patients with chronic colonic pseudo-obstruction rather than ACPO. That article, however, makes the point that CT may be more helpful than plain abdominal radiography for accurate measurement of cecal diameter because fluid or fecal material can obscure the margins of the cecum on plain radiographs.
Because most perforations occur in patients with cecal diameters of 12 cm. or greater, that parameter (i.e. cecal diameter = 12 cm.) is generally used as the point where conservative management should be replaced by more interventional management.
Conservative management usually consists of keeping the patient NPO and correcting any contributing factors like fluid and electrolyte disturbances. Nasogastric tubes and suction are probably of limited efficacy. Rectal tubes have been used but probably don’t do much to decompress the proximal colon. Ambulation and frequent patient repositioning are thought to help propel colonic gas more distally. It probably also makes sense to discontinue any drugs that may inhibit GI motility (eg. opiates, anticholinergics).
Most cases of ACPO resolve spontaneously with conservative therapy in a median of 4 days (Batke 2008). However, interventions (pharmacotherapy or therapeutic colonoscopy) may be necessary in those who do not respond to conservative therapy. Management algorithms are proposed by several authors (Batke 2008, De Giorgio 2009, Jain 2012, Nelson 2006). The usual first intervention is such cases is a trial of intravenous neostigmine. See any of those 3 articles for details about the dose of neostigmine, the parameters that need to be monitored, the potential side effects and contraindications, and the potential need for repeat doses. The article by Jain and Vargas (Jain 2012) also discusses some of the novel potential pharmacological interventions. In those failing to respond to either conservative treatment or neostigmine, colonoscopic decompression may be recommended. Because colonoscopy does carry a risk of perforation, it should only be done by an experienced endoscopist, with as little air insufflation as possible, and should be discontinued if signs of colonic ischemia are seen. Some have also utilized tube placement in the right colon, though the evidence base is not substantial at this time. Colonoscopic decompression is said to be effective in up to 80% of cases though randomized controlled trials have not been done and some patients require a repeat procedure. The above reviews also discuss the potential use of percutaneous transperitoneal cecostomy. Because of the very high mortality rates associated with surgery, surgery is usually reserved for those with evidence of colonic ischemia, perforation or peritonitis.
That part of the proposed algorithms suggesting a trial of neostigmine prior to decompressive colonoscopy has recently been challenged (Tsirline 2012). Those authors did a retrospective review of 100 patients with ACPO over a 10-year period and found that colonoscopy was significantly more successful than neostigmine after one intervention (75% vs. 35%) or two interventions (85% vs. 56%) with little difference in procedural morbidity. In addition, cecal diameters decreased more significantly with colonoscopy. Though this was not a randomized controlled trial and it was not clear why certain patients got neostigmine first and others got decompressive colonoscopy first, the authors suggest that colonoscopy should be considered first line therapy for ACPO.
Though we’ve emphasized ACPO following orthopedic procedures, the condition has been reported in association with a variety of other disorders. Overall, a majority occur following surgery or trauma (Tenofsky 2000) but it has also been associated with burns, myocardial infarction, neurological disorders, severe infections, metabolic and electrolyte disturbances, pediatric hematologic malignancies, herpes zoster, and others. There is a male preponderance of ACPO in the literature and the condition is more frequent in older patients. However, this may well reflect the underlying medical conditions and surgical procedures in this patient population. The condition, of course, may be seen at any age and certainly occurs in women as well. In fact, one of the most common antecedent surgeries is cesarean section (Mainguy Le Gallou 2011). So we are not picking on orthopedic surgeons! It just turns out that ACPO is probably more commonly seen after orthopedic procedures.
Clearly, recognition of ACPO is crucial. That is where the timing of onset is important from a patient safety perspective. In the study done by Nelson and colleagues (Nelson 2006) on ACPO after lower extremity arthroplasties the onset of symptoms occurred at an average of 3.4 days after the day of surgery (in patients who were on PCA the median onset of symptoms was 2.2 days). In the Chinese study (Zhang 2011) the onset of ACPO after total knee or hip arthroplasty was 2.5 days. In the study done by Tenofsky and colleagues (Tenofsky 2000), which included not only orthopedic cases but multiple other types of surgery, the mean interval from operation to diagnosis of ACPO was 5.1 days. As we have ratcheted down hospital lengths of stay over the years, the time frame of 3-4 days is one in which decisions are often made for discharging such patients either to home or a subacute setting. As above, since the major early symptom is abdominal distension and pain may be minimal and the patients don’t look particularly “toxic”, one can readily see how such patients might get transitioned to that next level of care before a diagnosis of ACPO is made. Add to that the fact that, in academic settings, the least experienced member of the team may be the one doing most of the discharge interactions. That individual may never have even yet seen a case of ACPO.
Maybe we need to add a blurb about abdominal distension as a possible warning sign in our discharge materials for patients after surgery. More importantly, if the patient tells you he can’t buckle his pants because his abdomen is so distended, don’t send him home!
Ogilvie H. Large-intestine colic due to sympathetic deprivation; a new clinical syndrome. Br Med J 1948; 2: 671–673
Dudley HAF, Sinclair ISR, McLaren IF, NcNair TJ, Newsam JE. Intestinal pseudo-obstruction. J R Coll Surg Edinb 1958; 3: 206–217
De Giorgio R, Knowles CH. Acute colonic pseudo‐obstruction. British Journal of Surgery 2009; 96(3): 229-239
Nelson JD, Urban JA, Salsbury TL, et al. Acute Colonic Pseudo-Obstruction (Ogilvie Syndrome) After Arthroplasty in the Lower Extremity. J Bone Joint Surg Am 2006; 88(3): 604-610
Norwood MG, Lykostratis H, Garcea G, Berry DP. Acute colonic pseudo-obstruction following major orthopaedic surgery. Colorectal Dis. 2005;7(5): 496-499
Zhang JH, Ling J, Liu H, et al. Case-control study on acute colonic pseudo-obstruction after total hip or knee arthroplasty. [Article in Chinese] Zhongguo Gu Shang 2011; 24(6): 456-458
Batke M, Cappell MS. Adynamic ileus and acute colonic pseudo-obstruction. Med Clin North Am 2008; 92(3): 649–670
Tenofsky PL, Beamer RL, Smith RS. Ogilvie Syndrome as a Postoperative Complication. Arch Surg 2000; 135(6): 682-687
Jain A, Vargas HD. Advances and Challenges in the Management of Acute Colonic Pseudo-Obstruction (Ogilvie Syndrome). Clin Colon Rectal Surg 2012; 25(1): 37–45
Choi JS, Lim JS, Kim H, et al. Colonic Pseudoobstruction: CT Findings. American Journal of Roentgenology 2008; 190: 1521-1526
Tsirline VB, Zemlyak AY, Avery MJ, et al. Colonoscopy is superior to neostigmine in the treatment of Ogilvie's syndrome. The American Journal of Surgery 2012; 204(6): 849-855
Mainguy Le Gallou C, Eboué C, Vardon D, et al. Ogilvie's syndrome following cesarean section: Just think! Report of two cases and review of the literature. J Gynecol Obstet Biol Reprod (Paris) 2011; 40(6): 557-563
May 21, 2013
Distractions and interruptions are frequent contributing factors to errors in all healthcare settings. But in the perioperative setting they are especially prone to result in errors that impact patient outcomes. Several recent papers have highlighted the many issues involved in producing interruptions and distractions in the perioperative setting.
Jacqueline Ross (Ross 2013) recently highlighted in an editorial those interruptions and distractions that often take place in the preoperative holding area, the OR, the PACU, and the several handoffs that take place among these areas. She correctly points out that many of these are likely not preventable but others are preventable. Two of the areas in which distractions might be prevented are OR traffic and use of wireless devices in these areas. She appropriately invokes the aviation concept of the “sterile cockpit” that we have used so often. During crucial portions of a procedure (eg. pre-op huddle, surgical timeout, induction, surgical incision, closure, debriefing, anesthesia emergence, etc.) there should be no extraneous conversations and all should focus on the task at hand. She suggests limiting the number of people entering or leaving the OR during those critical tasks.
She then reopens the controversial debate about cellphones (or other mobile electronic devices) in the OR (or other perioperative areas). That debate has been ongoing for quite some time now and, unfortunately, has so many pros and cons that resolution has been slow.
Shortly after the incident where 2 airline pilots overflew their destination because they had become so engrossed in their laptop computers, Dean raised the question of the need to ban personal computer use in the OR (Dean 2010). He cited the statistics on how reaction times are considerably longer while reading an e-mail or sending a text message than they would be if legally drunk. In our April 16, 2013 Patient Safety Tip of the Week “Distracted While Texting” we discussed the New York Times article on the potential patient safety issues related to distractions from electronic devices in hospitals (Richtel 2011). It describes things like a neurosurgeon making personal calls on a cell phone via wireless headset during an operation, and a nurse in the OR using an OR computer to check airline prices during an ongoing operation. It quoted an article from the journal Perfusion (Smith 2011) which found that 55 percent of technicians who monitor bypass machines acknowledged to researchers that they had talked on cellphones during heart surgery. Half said they had texted while in surgery. The NYT article also cites an article by anesthesiologist Dr. Peter Papadakos (Papadakos 2011). In that article he quotes an abstract presented at the 2011 annual meeting of the American Society of Anesthesiologists that nurse anesthetists and residents were distracted by something other than patient care in 54% of cases—even when they knew they were being watched! Most of what took their time were pleasure cruises on the Internet (abstract 1726).
Now a new study has looked at how background noise in the OR might interfere with surgical team communication (Way 2013). This study got quite a bit of press, probably because one of the background noises considered was music in the OR. In a simulated OR setting the investigators looked at the ability of 15 surgeons (who had normal hearing sensitivity) to understand and repeat words against a varying background of noises whether or not they were performing tasks. They found that the impact of noise is considerably greater when the participant is tasked. Moreover, the performance was poorer when the sentences were low in predictability. One can readily see from their results how background noise could interfere with the surgeon’s ability to understand communications during a critical task, particularly if the communication is not a predictable one. The authors conclude that to avoid possible miscommunication in the OR, attempts should be made to reduce ambient noise levels. The authors plan on extending the study to include other members of the surgical team and to also assess the impact in surgeons who have some hearing impairment to start with.
Our July 31, 2012 Patient Safety Tip of the Week “Surgical Case Duration and Miscommunications” highlighted a study (Feuerbacher 2012) of surgical residents in an OR simulator environment that clearly demonstrated the impact of OR distractions and interruptions (ORDI’s) in producing surgical errors. Eight of eighteen participants committed significant surgical errors during simulated laparoscopic cholecystectomy when distracted or interrupted, compared to only one of eighteen who were not interrupted or distracted.
Interruptions increase the likelihood of errors because we must refocus to resume where we had left off in our task prior to the interruption. It turns out that even very brief interruptions can have a marked impact on our ability to resume those tasks. Altmann and colleagues recently studied the effect of short interruptions on performance of a task that required participants to maintain their place in a sequence of steps (Altmann 2013). Interruptions averaging just 2.8 s long doubled the rate of sequence errors and interruptions averaging 4.4 s long tripled the rate of sequence errors on post-interruption trials relative to baseline trials.
Think of all the interruptions that occur during a surgical procedure. Even those short interruptions, especially if they occur during critical parts of procedures or when novel or unexpected events have occurred, could profoundly increase the odds of errors and untoward patient outcomes.
Ironically, most of us don’t even recognize when and how often we are being distracted. There are a couple ways to get a better handle on that, though both are resource-intensive. One is to do video/audio recording in the OR (or other perioperative setting) and then play it back for all parties in a constructive fashion so they can see how well (or not so well) they communicated and how distractions interfered with their communications.
The other is to use the direct observational methodology that we mentioned recently in several columns. That method relies on having specially trained observers within the perioperative setting to observe and record all events taking place (and it usually requires more than one observer at a time). In our November 27, 2012 Patient Safety Tip of the Week “Dealing with Distractions” we noted a study that used direct observation of anesthetists and anesthesiologists as they cared for patients from the time the anesthetist and patient entered the anesthetic room until recovery (Campbell 2012). They found an average of 0.23 interruptions per minute overall but the interruption rate differed during various stages of the overall process. Interruptions came from a variety of sources (internal team members, external team members, equipment-related issues, workspace design issues, noise, teaching responsibilities, patient-related problems, and items such as pagers and mobile phones). The authors did note that not all interruptions have negative impact. In fact, 3.3% had a positive impact (i.e. the distraction or interruption facilitated either the procedure or the safety of the patient). They went on to discuss strategies used by the anesthesia personnel for coping with distractions and interruptions. We also noted the utility of the direct observational methodology in our October 23, 2012 Patient Safety Tip of the Week “Latent Factors Lurking in the OR”.
We’ve done a number of columns on the deleterious effects of interruptions and distractions for physicians, nurses, pharmacists and others:
Ross J. Distractions and Interruptions in the Perianesthesia Environment: A Real Threat to Patient Safety. J Perianesth Nursing 2013; 28(1): 38-39
Dean S. Distractions in the Operating Room: Should the Use of Personal Computers Be Banned during the Administration of Anesthesia? APSF Newletter 2010; 25(1): 19 Spring 2010
Richtel M. As Doctors Use More Devices, Potential for Distraction Grows.,New York Times, December 14, 2011
Smith T, Darling E, Searles B. 2010 Survey on cell phone use while performing cardiopulmonary bypass. Perfusion 2011; 26(5): 375-380
Papadakos PJ. Electronic Distraction: An Unmeasured Variable in Modern Medicine. Anesthesiology News 2011; 37:11 November 2011
Way TJ, Long A, Weihing J, et al. Effect of Noise on Auditory Processing in the Operating Room. J Am Coll Surg 2013; 216(5): 933-938
Feuerbacher RL, Funk KH, Spight DH, et al. Realistic Distractions and Interruptions That Impair Simulated Surgical Performance by Novice Surgeons. Arch Surg 2012; (): 1-5 published online first July 2012
Altmann EM, Trafton JG, Hambrick DZ. Momentary Interruptions Can Derail the Train of Thought. Journal of Experimental Psychology: General, Jan 7 , 2013
Campbell G, Arfanis K, Smith AF. Distraction and interruption in anaesthetic practice.
Br. J. Anaesth 2012; 109(5): 707-715
Print “Perioperative Distractions”
May 28, 2013
The Neglected Medications:
For years we have pointed out that we often neglect to consider some interventions as “medications”. These include oxygen, heparin flushes, and IV fluids. We’ve often written about the issues with oxygen therapy and heparin flushes but we really haven’t done much with IV fluids.
So what’s the big deal about IV fluids? Well, NICE (UK’s National Institute for Health and Care Excellence) has pointed out that the quality and patient safety issues surrounding IV fluid therapy are so significant that they have just issued new draft guidelines for managing IV fluids (NICE 2013). They note that a study done in 1999 (NCEPOD 1999) had called attention to inadequacies in IV fluid management but that little progress has been made since (Findlay 2011).
Think about your own organization. You probably don’t consider IV fluid mismanagement as a “medication error” and therefore probably have no way of tracking how often such occur. But think about your RCA’s, case reviews, peer reviews, and M&M rounds. How often have you seen cases where your colorectal surgery patients go into pulmonary edema on POD 3 or 4? Or patients who become profoundly dehydrated during hospitalization because of inadequate attention to fluid balance? Or sepsis patients who get inadequate or untimely fluid resuscitation? Or patients who fall because of orthostatic hypotension where dehydration is a contributing factor? Or patients who develop electrolyte disturbances or aggravation of renal insufficiency? We’ll also bet that the majority of discharge summaries on your CHF patients fail to mention the “dry weight” (presumably representing the optimal fluid balance state for that patient). Get the picture? The problems with fluid management are fairly widespread but, because we don’t measure and track them, we continue to ignore them.
Quoting the NICE guideline: “Errors in prescribing IV fluids and electrolytes are particularly likely in emergency departments, acute admission units, and general medical and surgical wards because staff in these areas often have less relevant expertise than those in operating theatres and critical care units. Surveys have shown that many staff who prescribe IV fluids know neither the likely fluid and electrolyte needs of individual patients, nor the specific composition of the many choices of IV fluids available to them. Standards of recording and monitoring IV fluid and electrolyte therapy may also be poor in these settings. IV fluid management in hospital is often delegated to the most junior medical staff who frequently lack the relevant experience and may have received little or no specific training on the subject.”
The 1999 NCEPOD (National Confidential Enquiry into Perioperative Deaths) report noted that as many as one in five patients on IV fluid/electrolyte therapy suffer complications or morbidity due to their inappropriate administration (NCEPOD 1999). That report recommended that fluid prescribing be elevated to the same status as drug prescribing. A more recent NCEPOD report (Findlay 2011) showed that the 30 day mortality in those patients in whom the with inadequate pre-operative fluid management was 20.5% compared to 4.7% mortality in those with adequate pre-operative fluid therapy, reinforcing previous evidence of the beneficial effects of optimisation of fluid status prior to surgery.
We continue to see wide variation in the types of IV fluids used, rates, parameters, and indications and rationales for IV fluid regimens in our hospitals. Development of standardized order sets, whether paper-based or CPOE-based, had helped reduce the variation somewhat but considerable variation in practice patterns persists. Fluid management often appears to be an afterthought.
The NICE draft guideline has a short version, full version, and a document with evidence and appendices. They appropriately point out that many IV fluid therapy practices were historically seldom evidence-based nor subject to the randomized controlled clinical trials we expect for drug therapies. They do grade the strength of the recommendations they make in the guideline.
The guideline stresses the “5 R’s”: Resuscitation, Routine maintenance, Replacement, Redistribution, and Reassessment. It offers separate algorithms for: (1) assessing a patient’s fluid and electrolyte needs, (2) resuscitation with fluids, (3) routine fluid maintenance, and (4) addressing existing deficits or excesses or ongoing abnormal losses. It provides a nice diagram demonstrating sources of ongoing fluid losses and discusses monitoring parameters and frequencies. It also recommends that your organization adopt reporting of critical incidents resulting from fluid mismanagement (it actually includes a table listing which consequences of fluid management should be considered for reporting).
The guideline has lots of recommendations regarding education, training, inservicing, and competency assessment for fluid management. It recommends that each organization or facility designate a lead person to oversee, audit and review IV fluid prescribing and patient outcomes.
It begins with the logical statement that you should only prescribe IV fluids where a patient’s needs cannot be met by oral or enteral routes and you should stop them as soon as possible. We often see patients in our hospitals receiving IV fluids when they don’t really need them. Note that in the US we often see inappropriate initiation of IV fluids to meet the criteria of utilization management guidelines! For example, the “criteria” for admission or continued hospitalization might “require” IV fluids at least at a certain rate. So we see lots of orders written for patients not really needing rates that high or not even needing IV fluids at all.
The algorithm for assessment and reassessment is quite good and includes many parameters and clinical and laboratory signs that might suggest the need for more aggressive fluid resuscitation, such as the NEWS score (see our September 11, 2012 Patient Safety Tip of the Week “In Search of the Ideal Early Warning Score” for links to all our previous columns on early warning scores). The guideline also offers advice on when to assess things like urine sodium or look for hyperchloremic acidosis, etc.
It has good recommendations into consideration of various clinical and laboratory parameters in determing the best compostion of the IV fluids. It has good information about what to include in IV fluids (eg. including some glucose in maintenance IV fluids helps limit starvation ketosis) and what not to include (eg. recent large randomised controlled trials suggest that crystalloids are superior to 6% hydroxyethyl starch for resuscitation and the latter increases mortality and complication rates).
The guideline also stresses that when patients are transferred to another service or location, a review of their fluid status and management should be part of the handoff.
We have some of our own comments about the guideline and about fluid management in general.
First, we are delighted to see one specific clinical test included in the assessment algorithm of the NICE guideline. That is the passive leg raising test. Back in the late 1970’s, armed with just a little knowledge about baroreceptor physiology, we used to challenge our colleagues who relied upon pulmonary capillary wedge pressure measurements via invasive Swan-Ganz catheters vs. our using the simple bedside passive leg raising maneuver. We were usually able to predict better than the Swan-Ganz which patients needed more fluid vs. which ones already had too much! It’s great to see this simple useful bedside test make its way into these protocols.
We're also happy to see they have included assessment for postural hypotension in their assessment algorithm. We can’t tell you how many patients with syncope or dizziness we have seen over the years where no one had bothered to check for postural hypotension. And even in those rare patients in whom the physician has ordered monitoring for postural hypotension, it is rarely assessed in the proper manner. For the proper technique you can go to one of our many tirades on the topic of orthostatic hypotension (the most recent being in our January 15, 2013 Patient Safety Tip of the Week “Falls on Inpatient Psychiatry”).
The NICE guideline makes almost no mention of use of technology. We actually suspect that problems managing fluid status may have actually worsened as an unintended consequence of technology. In the old days, the first thing we saw when we opened a patient’s chart or walked into their room was a flow sheet that had their vital signs, their I&O’s (input and output), and their weight all represented in graphic form. It was pretty easy to spot bothersome trends. Many of today’s EHR’s, however, don’t provide such graphically displayed data (or at least don’t make it easy to get to such displays in just a click). Theoretically, computers should make it easier to track fluid status. The computer should be able to be programmed to compare the fluid input to the measured output and perform a calculation of the estimated insensible losses, then display the net fluid deficit or excess in a graphic form along with the patient’s weight. You could even program in alerts when deficits or excesses are above whatever limit you set (or at least display those unwanted values in red), keeping in mind we want to avoid alert fatigue. So IT vendors get with it!!!
Another somewhat surprising barrier to accurate I&O recording has been the change in the nature of the nursing shift. Traditionally we have been used to ordering “Intake and Output qShift” and were used to seeing the values recorded every 8 hours. Now that 12-hour shifts (and other alternatives) have appeared, the recordings are less frequent and it is more difficult to promptly see any trends. For example, if we round on our patients at 7AM and 5PM we might now see only one I&O recording for the current day and not recognize until the following morning that there is a disparity.
Not everyone needs I&O’s measured every day. It is time-consuming for nurses to do these measurements. So, while it may be important to order I&O’s when a patient is first begun on IV fluids, their fluid status and the need for frequent continued measurements should be reassessed daily. As they stabilize, particularly when they get to the routine maintenance stage, you should consider whether the monitoring frequency can be reduced.
Note that the currently issued NICE guideline is a “draft” and might change prior to final implementation. So you should check back with the NICE website in a few months (anticipated publication date is November 2013) to see if any substance changes have been made. But the draft document is an excellent start and should get you thinking about ways to improve fluid management in hospitalized patients in your organization. We think you’ll find the algorithms and recommendations very helpful. It’s a nuts and bolts type document that takes a very practical approach to an area of patient safety that we have all overlooked for far too long.
NICE (UK’s National Institute for Health and Care Excellence). Intravenous fluid therapy: guideline consultation. (draft guideline) May 21, 2013
evidence and appendices
NCEPOD (National Confidential Enquiry into Perioperative Deaths). Extremes of age: the 1999 report of the National Confidential Enquiry into Perioperative Deaths, 1999
Findlay GP, Goodwin APL, Protopapa K, et al. Knowing the Risk: A review of the peri-operative care of surgical patients. A report by the National Confidential Enquiry into
Patient Outcome and Death (2011)
June 4, 2013
For many years scientists have warned of the risk of radiation-induced cancers that might develop after exposure to radiation doses involved in medical tests such as CT scans. Those risks have been largely theoretical and based upon cancer rates in Japan following the nuclear bomb explosions in World War II.
In our April 2013 What’s New in the Patient Safety World column “Radiation Risk of CT Scans: Debate Continues” we discussed two recent studies that had somewhat conflicting views of the risks of radiation at least as regards cancer risks.
One of the first studies to actually demonstrate such an increased risk attributable to CT scanning (Pearce 2012) showed that use of CT scans in children was associated with increased risks of leukemia and brain cancer. But the cumulative absolute risks were actually relatively small. In the 10 years after the first scan for patients younger than 10 years, one excess case of leukaemia and one excess case of brain tumor per 10 000 head CT scans were estimated to occur. The authors concluded that, although clinical benefits should outweigh the small absolute risks, radiation doses from CT scans ought to be kept as low as possible and alternative procedures, which do not involve ionizing radiation, should be considered if appropriate.
The other study (Zondervan 2013) showed the risk of death from underlying morbidity is more than an order of magnitude greater than death from long-term radiation-induced cancer. They looked at the reasons for CT scans and the mortality rates of the underlying medical conditions. They found that young adults who have had 1 or more computed tomography (CT) scans earlier in life are at significantly greater risk of dying from underlying medical conditions than from radiation-induced cancer.
Now a third study adds even more to the debate. Mathews and colleagues (Mathews 2013) reviewed data from an Australian database of over 11 million patients and analyzed the incidence of cancer in 680,000 young patients exposed to CT scans. Mean followup in these patients was almost 10 years. Compared to those not exposed to CT scans the incidence of cancer in those exposed to CT scans was 24% higher. Brain cancer had the highest risk but the risk for almost all cancers was increased (note that the previous study by Pearce et al. was not powered enough to determine whether cancers other than brain cancer and leukemia were associated with CT scans). The risks were highest for those children having their first CT scan before age 5 years. Moreover, the risk of cancer increased further with each subsequent CT scan.
But two considerations are important in analyzing this study. First, the absolute increased risk of cancer associated with CT scans was still small overall (9.38 per 100,000 patients for all cancers). Secondly, the study did not have full data on reasons for the CT scans. Many of the patients may have had CT scans ordered because of symptoms or underlying conditions known to be associated with cancers.
So the debate about the magnitude of the problem of unnecessary exposure to ionizing radiations continues. Nevertheless, our continued efforts to reduce patient exposure to unnecessary ionizing radition, particularly in the youngest patients, makes sense.
There are several potential ways in which the collective dose of radiation might be reduced:
While we still have not seen a national system for tracking cumulative radiation doses, there appears to have been a slight reduction in the rate of growth of CT scanning in the past couple years. Whether that is due to the Image Gently or Image Wisely campaigns or due primarily to the economic slowdown remains unclear.
While the bulk of our efforts should really be directed at avoiding unnecessary scans it also makes sense to minimize the exposure to ionizing radiation when a scan is really necessary. Since the series of incidents in which patients undergoing CT scanning were exposed to extremely high radiation doses (see our February 2, 2010 Patient Safety Tip of the Week “The Hazards of Radiation”) most hospitals have reviewed their CT scanning protocols and many have successfully reduced the radiation doses without reducing the clinical quality of the scans. So the radiation dosage from a single CT scan today may be considerably less than those done even 3 or 4 years ago.
One group used a multidisciplinary committee in a community hospital setting to reduce patient radiation dose, repeat rate, and variability in image quality (Siegelman 2013). The committee included radiologists, technologists, consultant medical physicists, and an administrator. This was really a proof-of-concept study that demonstrates it is possible to produce such improvements in quality and patient safety.
But our primary strategy to reduce the risks of radiation is still reducing the inappropriate use of imaging studies that use ionizing radiation. On several occasions we have talked about the Image Gently or Image Wisely campaigns, the purpose of which is to minimize the unnecessary exposure of patients to radiation (see our February 2, 2010 Patient Safety Tips of the Week “The Hazards of Radiation” and November 23, 2010 “Focus on Cumulative Radiation Exposure” and our What’s New in the Patient Safety World columns for March 2010 “More on Radiation Safety” and June 2011 “Progress in Reducing Radiation from CT Scans”).
We don’t do a particularly good job of explaining the potential risks and benefits of CT scans to patients. A recent survey of patients undergoing CT scans showed that only 17% of patients said that the risks and benefits were explained and they were given the opportunity to participate in the decision with their physician about whether to order the scan (Caverly 2013). 62% felt that the decision to order the scan was mainly the physician’s. Only a small percentage were able to state what the risks of radiation were. Also, notably absent in the discussions before the exams were the potential risks that might be associated with incidental findings.
Audit and feedback may be helpful in reducing unnecessary CT scans. We’ve seen several emergency departments that significantly reduced the variation in CT ordering rates by individual physicians simply by providing the individual statistics at their monthly departmental meetings.
In our November 23, 2010 Patient Safety Tip of the Week “Focus on Cumulative Radiation Exposure” we noted that use of clinical decision support rules is a good way to minimize the number of unnecessary CT scans as well as reduce costs. We noted the multitude of such rules available for determining when to perform head CT scanning in patients with minor head injuries. Recently, a promising clinical decision support rule for deciding whether to perform abdominal CT scans in children presenting to the emergency department with blunt abdominal trauma was developed (Holmes 2013).
Conditional imaging strategies (see our August 2009 What’s New in the Patient Safety World column “Imaging for Acute Abdominal Pain”), such as performing ultrasound first in children with acute abdominal pain and only doing CT scans if the ultrasound does not provide a diagnosis, may help reduce unnecessary CT scans. However, a shortage of ultrasound techs has left many community and rural hospitals without ultrasound coverage at night. There remains great variation across hospitals in the rates of abdominal CT scans in children with abdominal pain. More and more we will see that appearing as a measurement parameter of quality and patient safety.
Use of clinical decision support tools at the time an imaging study is being ordered is a logical opportunity to improve appropriateness of studies ordered. Previous studies looking at the impact of computer-generated alerts on test ordering in general have had mixed results. But several recent studies have demonstrated some promising results. Researchers at Brigham and Women’s Hospital in Boston examined the impact of providing decision support alerts regarding potential duplicate studies to providers ordering CT scans (Wasser 2013). The alerts noted any CT scans done on the same body part within the past 90 days and provided links to images and radiology reports. Such alerts for a potentially duplicate CT scan appeared for a third of CT orders. Those who received the alerts cancelled their CT scan order 6.0% of the time compared to only 0.9% in a control group of providers not receiving the alerts. The cancellation rates varied considerably by site, being 19.3% in primary care clinics.
Another study, done as a simulated exercise, looked at the impact of alerts about radiation dose or imaging costs on test ordering (Gimbel 2013). In this exercise 112 family physicians (about 2/3 of whom were residents) were presented with a hypothetical case of a 22 y.o. woman who had previous detection of a renal mass. They were asked what imaging study they would order next. They would make their choice. Then appropriateness criteria from the ACR were shown and they could change their choice. Then they were presented with a decision support alert regarding either radiation dose or test cost (randomly assigned to which type of information was presented first) and allowed to change their choice again. Seeing the ACR appropriateness criteria caused only slight changes in imaging choices. But in the group presented with radiation dose information first (65 physicians), the number of CT scans ordered dropped from 32 to 14. Information about cost of the CT did not further reduce CT orders. However, ultrasound orders increased from 25 to 36 after radiation dose information was presented and then further increased to 45 after cost information was provided. MRI’s dropped to none. The group that received cost information first (47 physicians) increased ordering a CT scan from 26 to 29 after seeing the ACR criteria but this was reduced to 16 after cost information was presented and then 15 after radiation dose was provided. The authors conclude that information about radiation dose and cost can influence physicians’ ordering patterns for imaging studies. But they also note that the order in which the information is presented is important. Those given radiation dose information first changed their ordering to ultrasound at the expense of CT or MRI. Those given cost information first significantly reduced their CT ordering in favor of ultrasound but did not further modify their choices when presented with radiation dose information.
Admittedly, this was a simulated exercise in a hypothetical patient. We don’t know if we’d see the same impact in a real-life setting. However, the results are very promising and certainly suggest that clinical decision support (CDS) might help us reduce both radiation dose and cost.
And don’t forget that CT scanning is not the only imaging study where radiation dose is a significant consideration. Cardiac imaging is another significant source for radiation to patients. Fortunately, such cardiac imaging is seldom done in the childhood and early adult patients in whom the cumulative risks of radiation of most concern. But recent evidence suggests we can also reduce the number of such cardiac imaging studies by using clinical decision support tools (Lin 2013). The authors studied the impact of an automated multimodality point-of-order decision support tool on appropriateness. They found that inappropriate testing decreased from 22% to 6% and appropriate testing increased from 49% to 61% after implementation of the tool. Intended changes in medical therapy also increased from 11% to 32%.
Managed care organizations have for many years utilized prior authorization for expensive studies like CT and MRI imaging. These have been successful at reducing overall rates for both types of imaging. But they have also led to more appropriate choice of the initial imaging study and reduced the “layering” of studies. Such programs may steer the ordering physician to a more expensive MRI scan rather than a CT scan when the MRI is the more appropriate study. They use algorithms similar to the ones underlying the clinical decision support tools noted above in the Lin study. However, compared to the inefficiencies of using the prior authorization phone calls, the tool used by Lin et al. took only about 2 minutes to complete.
But don’t be so overly concerned about the risk of the radiation dose that you forgo imaging studies that will truly add to the clinical management process. One of the studies noted above (Zondervan 2013) showed the risk of death from underlying morbidity is more than an order of magnitude greater than death from long-term radiation-induced cancer. Another study in this month’s American Journal of Roentgenology (Pandharipande 2013) shows that even radiologists may be confused about the risk of radiation dose. That study used a survey of physicians (residents, fellows, and attendings) presented with a hypothetical patient who had a history of multiple CT scans and now was being considered for another abdominal CT scan. The authors make the case that the “linear, no-threshold model” (for cancer risk from radiation) actually should lead to consideration only of the current examination, not the previous ones. Yet 92% of the respondents admitted that the prior history of radiation exposure influenced their decision even though most (61%) reported accepting the “linear, no-threshold model”. The authors caution that such concerns could lead to decisions to use other imaging modalities that might not provide the most appropriate information.
The Mayo Clinic has a good 5-minute video presentation on YouTube on talking points you can use with your patients regarding the radiation risk of imaging studies. It compares radiation dosages in today’s studies (where reduced dosages are now commonplace) to ambient radiation exposure. It appropriately acknowledges the two sides of the CT radiation dose/cancer risk debate and puts it in perspective for both physicians and patients.
Some of our previous columns on the issue of radiation risk:
Pearce MS, Salotti JA, Little MP, et al. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. The Lancet 2012; 380(9840): 499-505, 4 August 2012
Zondervan RL, Hahn PF, Sadow CA, et al. Body CT Scanning in Young Adults: Examination Indications, Patient Outcomes, and Risk of Radiation-induced Cancer. Radiology 2013; Published online February 5, 2013
Mathews JD, Forsythe AV, Brady Z, et al. Cancer risk in 680 000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians. BMJ 2013; 346: f2360 (Published 21 May 2013)
Siegelman JRQW, Gress DA. Radiology Stewardship and Quality Improvement: The Process and Costs of Implementing a CT Radiation Dose Optimization Committee in a Medium-Sized Community Hospital System.
Journal of the American College of Radiology 2013; published online March 13, 2013
Caverly TJ, Prochazka AV, Cook-Shimanek M. Weighing the Potential Harms of Computed Tomography: Patient Survey (Research Letter). JAMA Intern Med 2013; (): 1-2. published online first March 4, 2013
Holmes JF, Lillis K, Monroe D, et al. Identifying Children at Very Low Risk of Clinically Important Blunt Abdominal Injuries. Ann Emerg Med 2013; DOI: 10.1016/j.annemergmed.2012.11.009; Published online February 4, 2013
Wasser EJ, Prevedello LM, Sodickson A, Mar W, Khorasani R. Impact of a real-time computerized duplicate alert system on the utilization of computed tomography. JAMA Intern Med 2013; published online 22 Apr
Gimbel RW, Fontelo P, Stephens MB, et al. Radiation Exposure and Cost Influence Physician Medical Image Decision Making: A Randomized Controlled Trial. Medical Care 2013; POST AUTHOR CORRECTIONS, 17 April 2013
Lin FY, Dunning AM, Narula J, et al. Impact of an Automated Multimodality Point-of-Order Decision Support Tool on Rates of Appropriate Testing and Clinical Decision Making for Individuals with Suspected Coronary Artery Disease: A Prospective Multicenter Study. J Am Coll Cardiol. 2013; (): Online First doi:10.1016/j.jacc.2013.04.059
Pandharipande PV, Eisenberg JD, Avery LL, et al. Original Research. JOURNAL CLUB: How Radiation Exposure Histories Influence Physician Imaging Decisions: A Multicenter Radiologist Survey Study. American Journal of Roentgenology 2013; 200: 1275-1283 June 2013
Mayo Clinic video “Doing More with Less: Radiation Doses Dropping”
Print “Reducing Unnecessary CT Scans”
June 11, 2013
Amphotericin Mixups Continue
The California Department of Public Health has just issued its latest round of hospital fines for medical errors. We always review these because the root cause analyses and plans of correction included with them usually describe events that could occur at your hospital as well. So they usually have many lessons learned. This round had the typical series of retained foreign bodies, medication errors, and falls with injury. The case that caught our eye, however, was one in which a mixup of amphotericin B formulations led to the death of a pediatric patient (CDPH 2011). This is not a new problem. It has been encountered on multiple occasions and receives attention about every 5 years. There have been excellent reviews and recommendations about this from both ISMP (ISMP 1998, ISMP 2007) and ISMP Canada (ISMP Canada 2002, Koczmara 2011).
While most such incidents have occurred in acute care hospitals, they have also been reported in the home care setting (ISMP 1998).
The problem entails confusion between conventional amphotericin B and the liposomal formulation of amphotericin B, which have different dose ranges. In the California case a physician intended to order the liposomal formulation of amphotericin B (Ambisome) to treat a fungal infection in a pediatric patient with acute myeloblastic leukemia and a bone marrow transplant. The actual order, however, was for “amphotericin B, conventional” 375 mg IV every 24 hours. The maximum limit for a single daily dose of conventional amphotericin B is 1.5 mg per kg. For this particular patient, based on weight, the ordered dose was more than three times the maximum limit.
The inappropriately high dose was not picked up during review by a pharmacist nor by the nurse who administered the dose. The patient received the erroneous dose at 10:15 AM and subsequently experienced a cardiac arrest and died at 1:15 PM.
As is usual in cases with adverse patient outcomes, a cascade of errors and enabling factors combined to lead to the adverse outcome:
The plan of correction in the California case focused fairly heavily on education. While it is extremely important to bring this issue to the attention of all your clinical staff (that’s why were are doing this column!) we also need to be practical. For relatively rare events like this it is very likely that the education will no longer be remembered the next time the opportunity for the error arises. Therefore, it is imperative that we put system interventions in place to reduce the chance such events will occur (see our March 27, 2012 Patient Safety Tip of the Week “Action Plan Strength in RCA’s” and click here to see some slides we put together to help remember them. Remember: images are more likely to be remembered than words!)
On the CPOE screen for choosing drugs the conventional formulation of amphotericin B appeared as the first choice in a list. One problem we’ve encountered in some CPOE systems is that there are circumstances when multiple preparations of a drug may not appear on the screen at the same time. You may have to scroll down further even in an alphabetical list to see all preparations of a drug. It could be possible for a provider to just see the conventional preparation and not scroll down to see that there was also a liposomal preparation.
One of the interventions put in place in the California case was to eliminate the ability to order conventional amphotericin B for intravenous use from the CPOE system.
Today’s CPOE systems have, or should have, the capability to go much further in preventing overdosing with many drugs. Most require that a patient’s weight be input into the system. So rather than just having an alert pop up asking the provider to verify that the dose does not exceed 1.5 mg/kg (an alert that can be dismissed with the click of a mouse) the computer should be capable of doing the calculation, determining that the dose does exceed the maximum limit and forcing the provider to contact the pharmacist before that dose is authorized. That sort of “hard” alert should be used in cases where the action could be potentially fatal or lead to other very serious consequences.
The approach by the hospital in the California case was eliminating the ability to order conventional amphotericin B for intravenous use from the CPOE system. We are not told whether conventional amphotericin B was removed from the hospital formulary. We suspect it was not removed because there may still be indications for use of the conventional rather than the liposomal preparation. So essentially the California hospital accomplished what we were recommending above as a “hard” alert by instituting a constraint or a forcing function, i.e. the provider would have to call the pharmacy if he/she actually wanted the conventional amphotericin B preparation. We don’t know at this time which of these two approaches might be best. Both might have unintended consequences, such as the provider using the liposomal formulation when the conventional formulation was really indicated.
One recommendation for CPOE from both ISMP and ISMP Canada is to include the complete generic and brand names on the computer entry screens.
That same recommendation applies if you are writing an order for the drug. You should include both the complete generic and brand name for the drug. And use of both the generic and brand names should appear on the MAR (Medication Administration Record) and other places, such as ADC’s (automated dispensing cabinets) if these drugs are allowed in ADC’s (note below that both ISMP and ISMP Canada strongly discourage storage of amphotericin B products in ADC’s).
Use of standardized order sets is also very helpful, not just for frequently used regimens but also for less commonly used but high alert medications (like desmopresin or argatroban mentioned below). For amphotericin B your standardized order set can be constructed in a way to clearly differentiate the two drug formulations and help the provider in determining which formulation is used for which indication. On the standardized order set you might also be able to include orders for any ancillary studies you might want in monitoring treatment (eg. you might want to assess renal and hepatic function in a patient on amphotericin B) or interventions to minimize risk of side effects (eg. hydration recommendations). Such standardized order sets can be either paper-based or computer-based.
One recommendation for written orders or standardized order sets is to both write out the formula and the total dose for weight-based dosing (ISMP's guidelines for standard order sets). That, of course, helps the pharmacist or the dispensing nurse to perform a double check by redoing the calculation to verify that the total dose is correct.
Speaking of the double check, both ISMP and ISMP Canada recommend independent double checks for dispensing and administering amphotericin B. We’ve often written about the pros and cons of the double check (see our October 16, 2012 Patient Safety Tip of the Week “What is the Evidence on Double Checks?”) but we do recommend a true independent double check for high alert medications and would include amphotericin B formulations in that recommendation.
There are some particularly important lessons learned in the 2011 paper written by staff from ISMP Canada (Koczmara 2011). They reported on incidents reported to ISMP Canada involving amphotericin B and noted that 4 of the 5 incidents involved giving conventional amphotericin B when liposomal amphotericin B was intended, thus resulting in doses that were too high.
They really emphasize the storage issue. In one case described, conventional amphotericin B was obtained from an automated dispensing cabinet (ADC) by a nurse after an order to “continue amphotericin B” in a patient who had been receiving liposomal amphotericin B. As a result, the authors discourage storage of amphotericin B products in patient care areas or automated dispensing cabinets (ADC’s). They recommend that all amphotericin B products be restricted to preparing, labeling and dispensing by the pharmacy where there are built-in checking processes. However, they recognize that in circumstances where there might not be night availability of a pharmacist it may be necessary to have some product available elsewhere. In such cases the recommend the following:
Storage in the pharmacy needs to ensure that the different products are well differentiated (by labels, warnings, etc.).
Both ISMP and ISMP Canada have also noted the difference in appearance of the IV solutions for the two products. The conventional product has a clear amber appearance, whereas the liposomal product has a milky amber appearance. So pay particular attention if staff, patients or families note a change in appearance of the solution from one dose to another.
The ISMP Canada papers (ISMP Canada 2002, Koczmara 2011) also highlight another important, but often violated, practice: when renewing orders always write out the full order. They cite a case in which a patient was receiving liposomal amphotericin B and an order was given to “continue amphotericin B”. A copy of the order was not sent to the pharmacy and for 2 days nurses retrieved conventional amphotericin B from the ADC and administered it before the error was identified.
ISMP Canada also notes you should always question the need to add more than 2 vials to any IV solution (ISMP Canada 2002). Adding more than 2 vials should always be considered a “warning flag” and prompt staff to perform extra checks to verify the order. You would be surprised how often we encounter incidents of medication overdoses where we say “didn’t they get suspicious when they needed so many vials?” (see our December 14, 2010 Patient Safety Tip of the Week “NPSA (UK): Preventing Fatalities from Medication Loading Doses” for a case where 32 vials of phenytoin were erroneously used to make up an IV loading dose that was 10-fold higher than the intended dose).
Regarding the educational piece, it is also recommended that warnings that the two products are NOT interchangeable and have different dosage ranges be included at every opportunity (inservices, CPOE screens, standardized order sets, pharmacy storage and preparation areas, labels, ADC machines, MAR’s, etc.). It’s also important to ensure that detailed, technical drug information is easily and readily accessible in those clinical areas that use amphotericin products.
Including a clinical pharmacist as part of your multidisciplinary rounding team is a huge advantage for those hospitals that can afford it (we often argue that hospitals cannot afford not to include them). For those that cannot put a pharmacist with each and every physician or service, periodic review of orders with a pharmacist may be valuable. The California hospital began having weekly meetings of a pharmacist with pediatric residents to review errors in orders written and all housestaff now participate in a medication error awareness workshop three times a year.
Don’t forget to educate the patient and family (or other caregivers) as well. Since the duration of amphotericin B treatment often exceeds the period of acute hospitalization, patients may have continuation of treatment at home or in alternative settings.
The FDA also has a very good patient safety video “Avoiding Mixups between Amphotericin B Formulations”, done in conjunction with ISMP.
Most hospitals’ high alert medication lists focus on insulin, opiates, anticoagulants, chemotherapy agents, neuromuscular blocking agents and others that might be used frequently at their facilities. However, we often recommend that you include on your list of high alert medications those that are seldom used but, often for that very reason, may be used inappropriately. We’ve previously talked about argatroban and desmopressin (see our March 18, 2008 Patient Safety Tip of the Week “Is Desmopressin on Your List of Hi Alert Medications?”). Methotrexate might be another (see our July 2010 What’s New in the Patient Safety World column “Methotrexate Overdose Due to Prescribing Error” and our May 7, 2013 Patient Safety Tip of the Week “Drug Errors in the Home”). Those drugs that are used infrequently but have a narrow therapeutic index or possible severe adverse side effects are good ones to put on your high alert medication list. These are the ones where development of standardized order sets and hard-stop CPOE alerts may be indicated. Amphotericin B is another obvious inclusion for your high alert medication list.
California Health and Human Services Agency Department of Public Health (CDPH).
State of Deficiencies and Plan of Correction. 2011
ISMP (Institute for Safe Medication Practices). Worth Repeating...Preventing mix-ups between various formulations of amphotericin B. ISMP Medication Safety Alert! Acute Care Edition 2007. September 6, 2007
ISMP Canada. Warning: prevent mix-ups between conventional amphotericin B (Fungizone) and lipid based amphotericin B products (Ambisome and Abelcet). ISMP Canada Safety Bulletin 2002; 2(6): 1-2 June 2002
ISMP (Institute for Safe Medication Practices). Another ampho-terrible mix-up. ISMP Medication Safety Alert! Acute Care Edition 1998. July 15, 1998
Koczmara C, Richardson H, Hyland S, et al. ALERT: Mix-ups between conventional and lipid formulations of amphotericin B can be extremely dangerous. Dynamics (Journal of the Canadian Association of Critical Care Nurses) 2011; 22(1): 24-26
ISMP (Institute for Safe Medication Practices). ISMP’s Guidelines for Standard Order Sets.
FDA Patient Safety Video. Avoiding Mixups between Amphotericin B Formulations. January 28, 2008
Print “Amphotericin Mixups Continue”
June 18, 2013
DVT Prevention in Stroke - CLOTS 3
Patients with acute stroke present us with a number of difficult decisions. In addition to investigations on the underlying pathophysiology of the stroke and treatment aimed toward that pathophysiology, much of the care of the stroke patient is aimed at preventing complications such as aspiration, decubiti, urinary tract infections, and venous thromboembolism (DVT and pulmonary embolism). Patient with acute stroke, particularly those with significant lower extremity weakness, are at very high risk for DVT and pulmonary embolism. This applies to both acute ischemic infarcts and intracerebral hemorrhages. And in both types there is either significant risk of hemorrhagic transformation or worsening of hemorrhage when pharmacological prophylaxis is used.
So we have long faced this dilemma in determining the best course of action to prevent VTE in stroke patients. Guidelines have suggested use of pharmacoprophylaxis in patients at high risk for VTE who are low risk for bleeding. Yet identification of such patients is almost impossible. Potential mechanical alternatives or adjuncts include graduated compression stockings and intermittent pneumatic compression devices (IPC’s).
Our What’s New in the Patient Safety World column for July 2009 “Unintended Consequences of a DVT Prevention Strategy” reported on a study (CLOTS trial 1) which showed that not only do thigh-high graduated stockings not prevent DVT in stroke patients, they actually cause harm. Skin breaks, ulcers, blisters, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use.
But then the CLOTS Trial 2 published results that confused the issue (see our October 2010 What’s New in the Patient Safety World column “Graduated Compression Stockings: CLOTS Confuses Clinicians”). Clots Trial 2 compared thigh-length graduated compression stockings to below-knee stockings and found fewer cases of VTE with the thigh-length stockings. The study populations and protocols for the two trials were the same, though the sites differed. The CLOTS Trial 2 was discontinued early because of the results of CLOTS Trial 1 but had already reached its predetermined enrollment goal. Proximal DVT, the primary study outcome, had an absolute risk reduction in the thigh-length group of 2.5% and the relative risk reduction was 31%. There were no differences in distal DVT, pulmonary emboli or deaths between the 2 groups. There were more cases with skin problems in the thigh-length group but these were relatively mild.
The controversy continued with a series of papers highlighted in our April 19, 2011 Patient Safety Tip of the Week “DVT Prophylaxis in Acute Stroke: Controversy Reappears”. These discussed the issues associated as much with pharmacoprophylaxis as with mechanical prophylaxis. We ended that column by stating that, in the interim, we’d probably advocate for use of pneumatic compression stockings pending the results of the CLOTS-3 Trial, which is looking at both the efficacy and safety of pneumatic compression stockings in stroke patients.
Well, the results of the CLOTS-3 Trial have now been published. That prospective randomized single-blind controlled trial demonstrates a significant reduction in DVT in immobile hospitalized stroke patients treated with intermittent pneumatic compression devices (IPC’s). The primary end point, DVT in a proximal vein, occurred in 8.5% of patients in the IPC group, compared to 12.1% in the no-IPC group. That 3.6% absolute difference in the primary end point translates to a number need to treat (NNT) of 28 to prevent one proximal DVT.
The study also showed a trend toward lower mortality at 30 days in those in the IPC group (11% vs. 13%), though this was not statistically significant (the study was not powered to demonstrate a mortality benefit).
As somewhat anticipated there more skin complications in the IPC group (3% vs. 1% in the no-IPC group). There was no difference in falls with injury between the two groups.
As pointed out in the accompanying editorial (Stevens 2013) one of the biggest problems with IPC’s is adherence to their use. Only about a third of the patients in CLOTS-3 were able to keep the IPC’s on for the entire intended duration.
While IPC’s had been shown to reduce VTE in several surgical populations, this is really the first study to demonstrate such an effect in medical patients. While it is tempting to extrapolate these results to other medical patients, stroke patients may differ enough to make such extrapolation unwise. Stroke patients are particularly at risk for DVT. Their paralysis may differentiate them from other medical patients who are immobile but may still have the capability of muscular contraction in their legs.
Many stroke centers have already begun to utilize IPC’s as their primary VTE prevention intervention. It’s nice to know that there is now an evidence base to back up that practice.
Some of our previous columns on patient safety issues in stroke:
October 2010 “Graduated Compression Stockings: CLOTS Confuses Clinicians”
April 19, 2011 “DVT Prophylaxis in Acute Stroke: Controversy Reappears”
June 26, 2007 “Pneumonia in the Stroke Patient”
June 15, 2010 “Dysphagia in the Stroke Patient: the Scottish Guideline”
April 2011 “Harm from NPO Orders”
February 2012 “Swallowing Evaluation in Stroke”
July 2012 “Progress on Swallowing Testing in Stroke”
November 6, 2012 “Using LEAN to Improe Stroke Care”
March 2012 “Helicopter Transport and Stroke”
September 2012 “Obstructive Sleep Apnea in Stroke Patients”
December 21, 2010 “More Bad News About Off-Hours Care”
October 7, 2008 “Lessons from Falls from Rehab Medicine”
June 2013 “Barriers to CAUTI Prevention”
The CLOTS Trials Collaboration. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial. The Lancet 2009; 373:1958 - 1965, 6 June 2009
The CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration. Thigh-Length Versus Below-Knee Stockings for Deep Venous Thrombosis Prophylaxis After Stroke
A Randomized Trial. (CLOTS 2) Annals of Internal Medicine 2010. Published early on line September 21, 2010
CLOTS Trials Collaboration. Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): a multicentre randomised controlled trial. The Lancet 2013; Early Online Publication
31 May 2013 doi:10.1016/S0140-6736(13)61050-8
Stevens SM, Woller SC. Intermittent pneumatic compression in patients with stroke. The Lancet 2013; The Lancet, Early Online Publication, 31 May 2013
June 25, 2013
Update on Surgical Fires
Just about every year we find ourselves doing a column on surgical fires. Despite all the efforts at prevention of these disastrous events they continue to occur.
The most recent case in the news involved a 55 y.o. woman who was undergoing a procedure in her temporal region (the report says temporal lobe biopsy but we wonder if it was a temporal artery biopsy) in whom electrocautery ignited a fire in the presence of oxygen, resulting in third degree facial burns to the patient (Breslow 2013a, Breslow 2013b). Details were not provided in the articles but the patient refers to “oxygen in my nose, and then a big sound and they met, right in my face and it set my face on fire”.
A recent review by the Pennsylvania Patient Safety Authority (Clarke 2012) found rates of surgical/OR fires to range from 0.90 per 100,000 patients to 0.33 per 100,000 patients. Though there has been a downward trend in the incidence of these over the last few years in the Pennsylvania database, this did not reach statistical significance.
An analysis of closed malpractice claims involving surgical fires provides a considerable amount of insight (Mehta 2013). Though data from a closed claims database significantly underestimates the total occurrence of OR/surgical fires, it does provide insight into trends and contributing factors. Claims more often involved older outpatients, compared to other types of claims. 99% involved procedures known to be high risk for fires (head, neck, or upper chest surgery). Electrocautery was the ignition source in 90% of claims and oxygen was the oxidizer in 95% of claims. Alchohol-containing prep solutions and volatile compounds were identified in only 15% of OR fires during monitored anesthesia care. Importantly, the vast majority of claims were for fires that occurred during monitored anesthesia care rather than general anesthesia. That highlights the importance of oxygen. In the vast majority of claims involving monitored anesthesia care the oxygen was delivered by an open delivery system.
On the other hand, the OR fires during general anesthesia more often the airway and leaks surrounding endotracheal tubes were a major factor.
So it certainly seems that there has been a trend for surgical/OR fires to be seen more often in relatively minor surgery (eg. plastic procedures removal of skin lesions, temporal artery biopsies, etc.), done under sedation or monitored anesthesia care where there is open delivery of oxygen.
The first component of the “fire triad” is an oxidizer. In most cases that is oxygen (nitrous oxide is the other potential oxidizer). In our November 2009 What’s New in the Patient Safety World column “ECRI: Update to Surgical Fire Prevention” we discussed the 2009 ECRI update of its “New Clinical Guide to Surgical Fire Prevention”. The 2009 key change in clinical practice is discontinuing the open delivery of 100% oxygen during procedures done during sedation and where high concentrations of oxygen are needed the airway should be secured. They discuss ways to minimize the concentration of oxygen being used in a variety of scenarios. The APSF recently highlighted the importance of this in their Winter 2012 newsletter (Stoelting 2012) and provide an algorithm regarding use of oxygen. Perhaps the most important question to ask is: does the patient need supplemental oxygen? Most probably do not, in which case room air should be used. But if greater than 30% oxygen concentration is needed to maintain oxygenation, the airway should be secured with an endotracheal tube or supraglottic device. In cases where supplemental oxygen at less than 30% is medically necessary they recommend use of a delivery device such as a blender or common gas outlet to maintain concentration below 30%.
However, just as important is timely communication between the surgeon and the anesthesiologist. As the surgeon plans to use the Bovie (or other potential heat source) he/she needs to let the anesthesiologist know and then the oxygen flow may be reduced or stopped temporarily. A period of time for allowing dispersal of oxygen should then pass before the surgeon uses the Bovie.
The second component of the “fire triad” is the heat source and, as in the closed claims study (Mehta 2013), electrocautery is the most common heat source for surgery/OR fires. While electrocautery was still the most common igniting mechanism in the PPSA study (Clarke 2012), they also noted fiberoptic light cords and lasers as responsible in some cases.
The third component is the fuel. While that can be anything that burns (clothing, drapes, cotton balls or sponges, gauze, skin, etc.) we have focused most often on alcohol-based skin preps or other volatile substances. In our April 24, 2012 Patient Safety Tip of the Week “Fire Hazard of Skin Preps Oxygen” we discussed a UK National Patient Safety Agency (NPSA) “signal” regarding the risk of alcohol-based skin preps in contributing to surgical fires (NPSA 2012). This Signal addresses the risk of a patient being burned when diathermy is used in the presence of alcohol-based skin preparation solutions. They identified 23 incidents of fire in which the involvement of skin prep was clearly stated and another ten incidents where diathermy was used and the involvement of skin prep was likely but not stated. Four of these incidents were reported as resulting in death or severe harm to the patient. Key contributing factors found include:
• insufficient time for drying of the skin prep solutions before commencement of surgery
• pooling of the skin preparations
In two cases, the volume of skin prep used was an issue. Common to several of the reports of fires (including an example given in the UK NPSA “signal”), additional skin prep was applied after the initial prep. The volume is important because the amount of run-off is important. It is the run-off that often saturates drapes, etc. and ultimately serves as the fuel for the fire.
The importance of the applicator becomes apparent when we discuss the volume issue. In one case the hospital had switched from using a forceps to the sponge applicator because the latter allowed for speedier application of the skin prep. But the amount of run-off is considerably higher with the sponge applicator. We’ve seen a similar case occur shortly after a hospital changed from a 10.5 ml sponge applicator to the same prep with a 26 ml applicator.
Allowing sufficient time for the skin prep to dry and any alcohol vapors to disperse is critical. We know of some hospitals that use a timer to ensure that sufficient time is allowed for that drying to occur. Search for the ideal skin disinfectant that prevents surgical site infections but is not flammable is still ongoing. Several studies now seem to show that chlorhexadine/alcohol is a better disinfectant than providone-iodine (see our April 2013 What’s New in the Patient Safety World column “Chlorhexidine in the News”). Unfortunately, the fire risk is much higher for the chlorhexadine/alcohol preparation. So careful attention to the drying time remains most important.
And while we haven’t yet seen a surgery/OR fire where it has contributed, hand sanitizers may also be flammable (see our April 2013 What’s New in the Patient Safety World column “Reminder: Hand Sanitizers Are Flammable”).
Take note of other potentially flammable fuels, too. The recently updated ASA Practice Advisory for the Prevention and Management of Operating Room Fires (Apfelbaum 2013) notes that the flammability of sponges, cottonoids, or packing material is reduced when wet rather than dry or partially dry. So it is recommended such materials be moistened when they will be in close proximity to heat sources.
We have long advocated that the surgical fire risk be discussed as part of the pre-op huddle (or pre-op briefing) and, if the case is considered high-risk, respective roles of all OR participants are called out during the surgical timeout. As part of an effort to promote fire safety in the OR (Murphy 2010), the San Francisco VA has developed a checklist “The Surgical Fire Assessment Protocol”. This checklist/protocol is actually printed on the reverse side of their larger preoperative checklist. This is really a very good tool! The fire risk is assessed by a simple numerical scale. If the score is 3 (high risk) the rest of the form is filled out, which basically delineates the respective roles of all those participants. That’s a really good way to remind all about their responsibilities if a fire occurred. We’ve also seen several hospitals incorporate questions about the fire risk into their modifications of the Surgical Safety Checklist. The Christiana Care Health System also has some good examples of incorporating the fire risk into Universal Protocol plus many other great tools in their Surgical Fire Risk Assessment resources.
While head, neck and upper chest surgeries have been considered to be at greatest risk for surgical fires, don’t forget that they can occur in almost any surgery. Our January 2011 What’s New in the Patient Safety World column “Surgical Fires Not Just in High-Risk Cases” pooling of the alcohol-based skin prep under the buttocks of a patient having a C-section in Israel was a key element in producing a surgical fire. And our April 24, 2012 Patient Safety Tip of the Week “Fire Hazard of Skin Preps Oxygen” described another ob/gyn case with a fire.
As you’ll recall, some great resources on surgical/OR fires have been made available in recent years, through organizations like ECRI Institute, the Anesthesia Patient Safety Foundation (APSF), the American Society of Anesthesiologists (ASA), AORN, the VA medical system, Christiana Care Health System, and the FDA. Links to those resources can be found in our many previous columns on surgery/OR fires listed below. The FDA collaborative initiative began in late 2011 and provides a whole host of valuable resources on surgical/OR fires. The APSF recently updated its algorithm into poster formats that can be downloaded (APSF poster). We previously mentioned the excellent APSF Fire Safety video (see our March 2011 What’s New in the Patient Safety World column “APSF Fire Safety Video”). And the ASA just recently updated its Practice Advisory for the Prevention and Management of Operating Room Fires (Apfelbaum 2013).
The ASA Practice Advisory for the Prevention and Management of Operating Room Fires (Apfelbaum 2013) has a good discussion of the steps and responsibilities of each OR team member if a fire does occur. As we’ve noted often in the past, there are some rare events that arise so suddenly that you can’t go to any resources to see how to handle them. The only way to know how to respond to a surgery/OR fire is to do drills or simulations so everyone knows what to do.
Our prior columns on surgical fires:
Patient Safety Tips of the Week:
What’s New in the Patient Safety World columns:
Breslow J. Family Says Hospital Patient's Face Caught Fire During Surgery. LEX18.com Apr 24, 2013
Breslow J. Hospital Patient Who Says Face Caught Fire During Procedure Talks To LEX 18. LEX18.com Apr 25, 2013
Clarke JR, Bruely ME. Surgical Fires: Trends Associated with Prevention Efforts. Pa Patient Saf Adv 2012; 9(4): 130-135
Mehta SP, Bhananker SM, Posner KL, Domino KB. Operating Room Fires: A Closed Claims Analysis. Anesthesiology 2013; 118(5): 1133-1139, May 2013
ECRI Institute. New clinical guide to surgical fire prevention. Health Devices.
ECRI Institute. October 2009: 314-332 (www.ecri.org).
Stoelting RK, Feldman JM, Cowles CE, Bruley ME. Surgical Fire Injuries Continue to Occur. Prevention May Require More Cautious Use of Oxygen. Anesthesia Patient Safety Foundation (APSF). APSF Newsletter 2012; 26(3): 41,43 Winter 2012
NPSA (UK). Risk of skin-prep related fire in operating theatres | Signal. 28 February 2012
Apfelbaum JL, Caplan RA, Barker SJ, et al. and the Committee on Standards and Practice Parameters. Practice Advisory for the Prevention and Management of Operating Room Fires: An Updated Report by the American Society of Anesthesiologists Task Force on Operating Room Fires. Anesthesiology 2013; 118(2): 271-290, February 2013
Murphy J. A New Effort to Promote Fire Safety in the OR.
Topics In Patient Safety (TIPS) 2010; 10(6): 3
SF VAMC Surgical Fire Risk Assessment Protocol
Christiana Care Health System. Surgical Fire Risk Assessment.
FDA. Preventing Surgical Fires.
FDA. Resources and Tools for Preventing Surgical Fires.
APSF (Anesthesia Patient Safety Foundation). Fire Prevention Algorhithm (poster).
Print “Update on Surgical Fires”
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