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December 1, 2015
Does It Work?
We’ve long been fans of TALLman lettering to help avoid look-alike sound-alike (LASA) drug errors. We’ve recommended its use (eg. HYDROmorphone) in our numerous columns on the dangers of Dilaudid. In fact, we’ve even sometimes suggested our own TALLman lettering schemes for certain LASA drug pairs (see our prior columns “Ophthalmology: Blue Dye Mixup” and “Another Blue Dye Eye Mixup”).
But does TALLman lettering actually reduce such errors? It is a very simple and logical concept so it makes a lot of sense to use. But, like any other patient safety intervention, we should assess whether it indeed reduces errors and does not introduce unintended consequences.
We were quite surprised when we read in a recent safety bulletin on TALLman lettering from ISMP Canada that there were no published studies demonstrating the effectiveness of TALLman lettering in reducing errors associated with drug name confusion (ISMP Canada 2015). Then about a week later came along a study in pediatric hospitals that showed the introduction of TALLman lettering was not associated with any reduction in potential LASA errors (Zhong 2015).
ISMP Canada, recognizing that overuse of this technique might reduce its effectiveness, recommends that use of TALLman lettering be restricted to drug name pairs associated with significant risk to patient safety (ISMP Canada 2015). Therefore, they embarked on a project that began with analyses of reported incidents from several Canadian databases and did a systematic risk assessment to determine which LASA pairs would benefit most from TALLman lettering. They then sought feedback and ultimately published a list of 33 LASA drug pairs. That list is considerably shorter than the 2011 list published by ISMP US (ISMP 2011).
The pediatric study (Zhong 2015) used pharmacy data for pediatric inpatients from 42 children's hospitals from 2004-2012. The researchers searched within each hospitalization for the occurrence of patterns for a total of 12 LASA drug pairs deemed highly relevant to pediatric inpatients. TALLman lettering was implemented in 2007. They performed segmented regression analyses to look for changes after the implementation. They found no downward trend in potential LASA drug error rates over any time period 2004 onwards. They conclude that whether TALLman lettering is effective in clinical practice warrants further study.
One issue that arises in discussions on TALLman lettering is whether we overuse it and create a “fatigue” similar to alert fatigue or alarm fatigue. That is one of the reasons the recent ISMP Canada list (ISMP Canada 2015) was kept so short.
ISMP (US) and other organizations put together TALLman lettering lists after seeking input from multiple stakeholders. An ISMP survey in 2008 showed that most hospitals were using TALLman lettering in some capacity and the majority felt that it was effective in reducing errors (Grissinger 2012). But those responses were largely subjective and anecdotal.
Experimental results in 2008 and early 2009, just as TALLman lettering was being more widely adopted, showed that TALLman lettering reduced drug name confusion errors in a series of laboratory-based tasks, in both younger and older adults, and healthcare practitioners (Filik 2010).
But even one of the studies used to endorse the implementation of TALLman lettering (Gerrett 2009) was somewhat cautious in its recommendations. It noted that, given the results of their lab experiments, the authors would advocate a pragmatic approach with the implementation of a specific rule-based Tall Man variant for a limited and specified set of look-alike, sound-alike medicines. They felt that this was unlikely to result in any greater harm when compared with the then current standard of lowercase or uppercase.
They noted the finding that error in practice was more likely to occur with dose (LASA errors are more likely to occur when the dose of the two drugs, in mg, is similar), formulation or a combination of these with look-alike medicine name highlights the need for broader research.
So does this mean we should stop using TALLman lettering conventions for high-risk LASA drug pairs? Hardly. But it does tell us that we need to do further research in adult populations to determine which TALLman conventions for which drugs are effective in actually reducing LASA errors. Remember, there are other methods that have been used to try to help us distinguish unique letters in drug names (different color letters, different color backgrounds, italics, underlining, different fonts, etc.). But those methods also have largely escaped systematic review for their effectiveness. Also unanswered is whether use of TALLman lettering is equally effective at the dispensing, preparation, or prescribing phases. Use of TALLman lettering probably does not result in harm. However, we also are unaware of any studies that have addressed unintended consequences of either TALLman lettering or any of the other methods. We’ll bet some are out there. Particularly for hospitals with long lists of LASA pairs you might find a TALLman convention for one pair might include a TALL sequence similar to yet another drug.
There have been so many patient safety initiatives that are so attractive in concept yet prove to be ineffective when we get around to actually measuring their impact. Let’s hope TALLman lettering does not fall into that category. But the Zhong study certainly suggests that we need to do a systematic review of the impact of TALLman lettering in multiple other venues.
While waiting for such future studies, it is probably wisest to reserve your TALLman lettering conventions for those LASA drug pairs with the most potential to have serious patient safety consequences in your organizations.
ISMP Canada. Application of TALLman Lettering for Selected High-Alert Drugs in Canada. ISMP Canada Safety Bulletin 2015; 15(10): 1-3 October 30, 2015
Zhong W, Feinstein JA, Patel NS, et al. Tall Man lettering and potential prescription errors: a time series analysis of 42 children's hospitals in the USA over 9 years. BMJ Qual Saf 2015; published online first November 3, 2015
ISMP. FDA and ISMP Lists of Look-Alike Drug Name Sets with Recommended Tall Man Letters. 2011
Grissinger M. Tall Man Letters Are Gaining Wide Acceptance. P&T® 2012; 37(3): 132-134
Filik R, Price J, Darker I, et al. The influence of tall man lettering on drug name confusion: a laboratory-based investigation in the UK using younger and older adults and healthcare practitioners. Drug Saf 2010; 33(8): 677-687
Gerrett D, Gale AG, Darker IT, et al. Tall man lettering: final report of the use of tall man lettering to minimise selection errors of medicine names in computer prescribing and dispensing systems. Loughborough (UK): National Health Service, NHS Connecting for Health; 2009 http://webarchive.nationalarchives.gov.uk/20130502102046/http://www.connectingforhealth.nhs.uk/systemsandservices/eprescribing/refdocs/tallman.pdf
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The most important interventions in preventing CAUTI’s (catheter-associated urinary tract infections) are (1) avoiding catheters in the first place and (2) minimizing their duration of use. In our multiple prior columns on CAUTI prevention (see the list at the end of today’s column) we’ve noted catheter duration can be reduced by questioning daily whether the catheter is still necessary, by using automatic stop orders, or by having protocols that allow nursing to remove catheters when certain criteria are met.
A recent study demonstrates just how powerful the latter intervention can be. Leis et al. at Sunnybrook Health Center in Toronto, Ontario developed consensus among their general medicine colleagues about criteria that would empower nurses to remove urinary catheters (Leis 2015). Nurses required only about a half hour of training on how to use the algorithm. They then applied it to all patients arriving on their ward with a urinary catheter and every day thereafter on patients with a urinary catheter. They compared catheter usage on wards on which the training and algorithm were implemented to that on wards on which they were not implemented (the “control” wards). Catheter days per patient were similar on the intervention and control wards before the implementation. After implementation of the project, catheter days fell to 8.5% vs. 14.8% on the control wards. The average catheter duration also fell on the intervention wards (2.8 days vs. 3.6 days on the control wards). More importantly, CAUTI’s fell from 1.7 per 1000 patient-days before to 0.2 after the intervention (on the control wards CAUTI rates per 1000 patient-days were 1.4 before and 1.5 after).
Importantly, none of the 8 catheter reinsertions were deemed to be due to inappropriate removal of catheters under the protocol.
The protocol applied only to medical patients and excluded patients with conditions like pre-admission permanent indwelling catheters, known bladder outlet obstruction, continuous bladder irrigation for hematuria, incontinent female patients with sacral decubiti, and patients with profound hyponatremia who were on strict I&O monitoring. Also excluded were patients on end-of-life comfort care (but see our June 30, 2015 Patient Safety Tip of the Week “What Are Appropriate Indications for Urinary Catheters?” regarding whether that is a valid criterion for indwelling catheters). The protocol also called for bladder ultrasound scans as part of the monitoring in patients after catheter removal.
The researchers cited physician consensus and buy-in and engagement of nurse leaders as key success factors.
Meanwhile, AHRQ just released its “Toolkit for Reducing CAUTI in Hospitals” (AHRQ 2015). The toolkit was developed as part of a multi-hospital project in which CUSP (Comprehensive Unit-based Safety Program) principles were used along with evidence-based CAUTI prevention measures. Preliminary results in those hospitals participating in the 4-year AHRQ project show a 15% reduction in CAUTI’s. The toolkit includes multiple tools, including:
It also has links to a host of prior AHRQ webinars on preventing CAUTI’s and using CUSP principles. It also has multiple resources for sustaining change and improvement.
Many of you are aware that AHRQ has recently been a target for elimination or significant budget reductions. It is projects such as this one and dissemination of the lessons learned and tools used that make AHRQ an agency that is very valuable to the health care community. It would be a shame to lose such a valuable asset.
Our other columns on urinary catheter-associated UTI’s:
Leis JA, Corpus C, Rahmani A, et al. Medical Directive for Urinary Catheter Removal by Nurses on General Medical Wards. Ann Intern Med 2015; published online first November 19, 2015
AHRQ (Agency for Healthcare Research and Quality). Toolkit for Reducing CAUTI in Hospitals. 2015
ECRI Institute has just published its annual Top 10 list for health technology hazards for 2016 (ECRI 2015). Our regular readers will not be surprised that alarm issues and opioid-induced respiratory depression are near the top of the list. But this year’s number one hazard is inadequate cleaning of flexible endoscopes before disinfection.
There has been a spate of reports recently of spread of deadly multi-drug-resistant organisms via inadequately cleaned and sterilized endoscopes. In particular, several fatal cases of carbapenem-resistant Enterobacteriaceae (CRE) were traced to inadequate cleaning of duodenoscopes. Disinfection and sterilization cannot eliminate bacteria that are covered with biologic debris. Therefore, adequate cleaning to remove such debris before the disinfection and sterilization steps are crucial. Duodenoscopes and other flexible endoscopes have complex designs that have lots of “nooks and crannies” that are difficult to clean.
As usual, ECRI Institute has done an excellent job of describing the hazards and making recommendations for organizations to address them. Here is the complete ECRI Top 10 list for 2016:
You can download ECRI Institute’s Top 10 Health Technology Hazards for 2016 for free at the ECRI site.
ECRI Institute. Top 10 Health Technology Hazards for 2016. ECRI Institute. November 2015
Far and away the most commonly implicated heat sources in OR/surgical fires have been electrocautery devices (see our December 16, 2014 Patient Safety Tip of the Week “More on Each Element of the Surgical Fire Triad”). But almost any heat source in a hyperoxygenated environment can lead to an OR/surgical fire.
Earlier this year an OR fire related to a cardioversion procedure occurred in Michigan (Counts 2015). Though the hospital apparently did not release details of the incident, news releases (Allen 2015) state that a spark from the cardioverter pad ignited a paper drape and mask covering the patient in an oxygen-rich environment. That resulted in a fire that injured the patient and several staff members.
It’s not the first time that a cardioverter or defibrillator has served as the heat source for an OR fire. In 2012 an OR fire in North Carolina that was fatal to a patient was triggered by a defibrillator (WRAL 2012). And in June 25, 2013 Patient Safety Tip of the Week “Update on Surgical Fires” we discussed a study from a closed claims database (Mehta 2013) in which there was one case where a defibrillator was the heat source.
The 2008 ASA Practice Advisory for the Prevention and Management of Operating Room Fires (ASA 2008) also mentions defibrillator paddles or pad as potential heat sources. Other heat sources mentioned in that advisory include electrosurgical or electrocautery devices, lasers, heated probes, drills and burrs, argon beam coagulators, and fiberoptic light cables.
And in a recent Web M&M, Mehta and Domino (Mehta 2015) discussed a case where a bag of bladder irrigating solution hanging over anesthesiologist’s accessory “slave” monitor dripped onto the power source, producing sparks and flames and filling the OR with black smoke. While the Mehta case was not an “on-patient” fire, it illustrates the same OR fire safety principles and the importance of discussing fire risk during the timeout and doing fire drills that all OR staff participate in. The staff in that case were very familiar with their roles in OR fires and responded promptly and appropriately.
AORN (AORN 2015) recently had some useful reminders on prevention of surgical/OR fires from Mark Bruley of ECRI Institute:
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. In our January 2011 What's New in the Patient Safety World column “Surgical Fires Not Just in High-Risk Cases” we noted the San Francisco VA checklist “The Surgical Fire Assessment Protocol” (Murphy 2010), 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. Bruley, in the AORN article, notes he has seen some surgical fire risk assessments take far too long and recommends teams tailor their fire risk assessment during Time Out to a model created in an algorithm and video from the Anesthesia Patient Safety Foundation (APSF 2010).
We’ve discussed Bruley’s recommendations on oxygen in several of our prior columns. Perhaps the most important question to ask is “Does the patient need supplemental oxygen at all?”. But if supplemental oxygen is required, Bruley notes it is recommended that it be administered through a secure airway via a tracheal tube or through a laryngeal mask, except for surgical cases where the patient must be able to speak during surgery. In such cases, 30% blended oxygen and air should be used to begin with.
Since the majority of surgical/OR fires in recent years seem to occur during relatively minor procedures, many such patients don’t have secure airways in place and then the need for supplemental oxygen may arise suddenly. The anesthetist then often simply delivers it via a face mask rather than taking time to use a tracheal tube or laryngeal mask. Therefore, it remains crucial that in all cases the surgeon and anesthesiologist communicate clearly, with the surgeon calling out his/her intention to use the electrocautery device (or other potential heat source such as a laser) and the anesthesiologist informing the surgeon to wait until oxygen has been discontinued and allowed to adequately dissipate before the electrocautery device is used.
In the AORN article Bruley also discusses the importance of educating all team members about the fire risk and what to do if a fire occurs. While we have always stressed that each member of the OR team needs to know their specific role in an OR fire (such as the anesthesiologist turning off the oxygen supply), Bruley notes that there should not be specific roles designated for extinguishing a surgical fire because time is of the essence. He stresses that any member of the surgical team should be ready to put out a fire.
The recent AHRQ Web M&M case illustrates the importance of each team member knowing what to do in the event a fire actually occurs. We can’t overemphasize the importance of training and drills for OR fires and planning prior to each case. While such fires are still relatively rare, the consequences can be devastating. The only way to be prepared for responding to such rare events is to have practiced such responses frequently.
Our prior columns on surgical fires:
Counts J. U-M cardiovascular center fire started during operation on patient, spread to curtain. Ann Arbor News 2015; July 7, 2015
Allen J. U-M not releasing report on cardiovascular center fire that burned patient. Ann Arbor News 2015; August 7, 2015
WRAL. Fatal Durham hospital fire may have started during defibrillation. WRAL.com Posted November 6, 2012
Mehta SP, Domino KB. Fire in the Hole!—An OR Fire. AHRQ Web M&M April 2015
ASA (American Society of Anesthesiologists). American Society of Anesthesiologists Task Force on Operating Room Fires. Practice advisory for the prevention and management of operating room fires. Anesthesiology 2008; (108): 786-801
Mehta SP, Bhananker SM, Posner KL, Domino KB. Operating Room Fires: A Closed Claims Analysis. Anesthesiology 2013; 118(5): 1133-1139, May 2013
AORN. 4 actions to improve fire safety. Periop Insider 2015
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
Opioid-induced respiratory depression is a major problem in hospitalized patients and post-operative patients (see our numerous columns listed below). But prescribed opioids are also a major cause of overdoses in outpatients and many patients who become addicted to opioids started with opioids that were prescribed for medical conditions. So careful use of opioids is important for many reasons.
CPOE (computerized physician order entry) and electronic prescribing with clinical decision support offer an important opportunity to reduce inappropriate use of opioids. These technological tools have the ability to alert clinicians to potency issues of the various opioids, remind clinicians of the opioid-naïve vs. opioid-tolerant issues, alert clinicians that a patient may also be taking other medications that can cause respiratory depression, and other issues.
But, just as with all our other clinical decision support interventions, the issue of “alert fatigue” rears its ugly head. Medication-related clinical decision support alerts are often ignored and several studies cite very high override rates ranging between 49% and 96% with a rate of 90% for drug–drug interaction (DDI) alerts specifically (Phansalkar 2013). And a recent study suggests that alert fatigue for opioids may actually be worse than for other drugs. Genco and colleagues (Genco 2015) did a retrospective chart review study assessing adverse drug event occurrences for emergency department (ED) visits in a large urban academic medical center using a commercial electronic health record system with clinical decision support.
Opioid drug alerts were 35% more likely to be overridden than non-opioid alerts. Opioid drug-allergy alerts were twice as likely to be overridden and opioid duplicate therapy alerts were 1.57 times as likely to be overridden.
Of those adverse drug events found in their ED patients, opioids did account for 57% but none of the adverse drug events were preventable by clinical decision support. However, they did identify 46 alerts that averted a potential adverse drug event.
Overall, 98.9% of opioid alerts did not result in an actual or averted adverse drug event, and 96.3% of opioid alerts were overridden. They found that to prevent 1 adverse drug event, providers dealt with more than 123 unnecessary alerts.
So does this surprise you? Probably not. In our March 3, 2009 Patient Safety Tip of the Week “Overriding Alerts…Like Surfin’ the Web” we recommended that you pick a relatively small number of serious things you are trying to prevent and use more interruptive techniques to discourage those things. Having way too many alerts of little consequence makes clinicians simply avoid all alerts just like you ignore all those flashing ads when you are surfing the internet.
Probably the biggest problem with opioids is the “allergy” issue. Every electronic medical record (or paper chart, for that matter) that we’ve ever seen lists all sorts of unwanted reactions to opioids under “allergies”. Typically, things like nausea and vomiting after opioids may lead a patient to state they are “allergic” to that opioid. So it’s no surprise that opioid drug-allergy alerts were overridden more than twice as often in the Genco study than drug-allergy alerts for other drugs. In fact, Genco and colleagues noted that retaining only exact and base ingredient matches as interruptive alerts could eliminate 85% of the interruptive drug-allergy alerts without eliminating those alerts that would prevent an adverse drug event. (They do recommend retaining such opioid intolerances in a “non-interruptive” fashion in the EMR).
Perhaps more surprisingly, however, are their recommendations regarding duplicate drug order or duplicate therapy opioid alerts. They note studies showing that opioid-naïve patients and patients receiving long-term opioid therapy have a 3- to 6-fold increased risk of overdose with a dose of 50 morphine equivalents per day. They, therefore, suggest future research look at using non-interruptive alerts if the morphine equivalent is less than 50 mg in the previous 24 hours and interruptive alerts for those higher than 50 morphine equivalents/day. We’ve seen far too many patients who develop respiratory depression at doses far lower than 50 morphine equivalents/day. Perhaps if you had a complete medical record in which a background search for other conditions predisposing to opioid-induced respiratory depression could be used to convert the alert to an interruptive one that threshold might be reasonable. But most ED EMR systems are not robust enough or comprehensive enough to pick up those conditions and modify the alert. We’d be very hesitant to use that threshold.
Keep in mind that the nature of alerts in the ED or outpatient venues might be different than that for hospital inpatients. For example, in a hospital inpatient having a condition that might predispose to opioid-induced respiratory depression (eg. obstructive sleep apnea) an alert might be used to ensure appropriate monitoring (eg. capnography) is done if any opioid is being prescribed for that patient.
Everyone agrees that the fewer interruptions you cause for physicians, the more they are likely to adopt CPOE. So you need to put your stake in the ground – pick a relatively small number of serious things you are trying to prevent and use more interruptive techniques to discourage those things. One alert we would definitely keep is the interruptive alert that alerts prescribers that HYDROmorphone is at least 7 times more potent on a mg basis than morphine. We also think that alerts flagging relatively high opioid doses in opioid-naïve patients are wise.
The key question is whether the non-interruptive alerts and reminders are of value. We spend a great deal of time developing many of those despite lack of good evidence that they actually change outcomes. They are the ones that are like the internet ads – we’ll bet you never pay attention to them either! The Genco study certainly suggests that we need to take a closer look at the alerts we use, both interruptive and non-interruptive, for opioids.
Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:
Our prior articles pertaining to long-acting and/or extended release preparations of opioids:
Our prior columns on patient safety issues related to Dilaudid/HYDROmorphone:
Some of our previoius columns on opioid safety issues in children:
Genco EK, Forster JE, Flaten H, et al. Clinically Inconsequential Alerts: The Characteristics of Opioid Drug Alerts and Their Utility in Preventing Adverse Drug Events in the Emergency Department. Ann Emerg Med 2015; published online first November 6, 2015
Phansalkar S, van der Sijs H, Tucker AD, et al. Drug–drug interactions that should be non-interruptive in order to reduce alert fatigue in electronic health records. J Am Med Inform Assoc 2013; 20(3): 489-493
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