What’s New in the Patient Safety World

July 2011



·        ECRI Alert on Patient Identification and Cardiac Monitors

·        More Problems With Methotrexate

·        And Digoxin Hasn’t Gone Away Either

·        First Thoughts on Dabigatran

·        NQF Adds 4 Events to Serious Reportable Events List

·        AAP Policy Statement: Principles of Pediatric Patient Safety





ECRI Alert on Patient Identification and Cardiac Monitors



In our June 19, 2007 Patient Safety Tip of the Week “Unintended Consequences of Technological Solutons” we wrote about an unfortunate case in which a patient died as the result of transposition of telemetry units with another patient. One day, right around nursing change of shift, two patients were admitted to the remote floor and telemetry was ordered on both. The nurse took two transmitters with him and hooked the patients up, then called the CCU monitoring nurse to tell her about the two patients just hooked up. About an hour later the CCU monitoring nurse called the remote floor because one of the patients was in ventricular fibrillation. A code was called and the floor staff and code team ran to the patient’s room, only to find him sitting in bed, watching TV and eating a meal. Only after several minutes of fiddling with his EKG leads and talking to the nurse in the CCU did anyone realize that the patient several rooms down the hall was really the one in ventricular fibrillation. The transmitters obviously had been transposed! (This is a variation of the “two in a box” phenomenon we talked about in the April 23, 2007 Patient Safety Tip of the Week “Predictable Errors”.) And, of course, the system was poorly designed in that it allowed the first nurse to take out two remote telemetry transmitters at the same time. We originally presented this case as an example of how a technological solution expected to enhance patient safety actually created a new unintended problem.


Now ECRI has issued a Patient Safety E-lert on the very same issue. They did not provide details of the cases in their database but did discuss contributing factors identified and made several good recommendations. They noted lack of good policies and procedures and lack of orientation and training plus communications failures as important contributory factors. They specifically noted things like change of shift, inexperienced staff, lack of familiarity with procedure, and distractions. They also note technological issues and workflow issues.


They recommend patient identification be verified each time a patient is hooked up to telemetry (and that means verification at both the patient’s end and the remote monitoring site). They stress that the telemetry receivers should incorporate a display with the patient identifiers to reconcile the telemetry transceiver with the correct patient (and to be especially cautious about patients with similar names). That patient identification needs to be done independently at the two sites to avoid confirmation bias.


To their recommendations we would reiterate that your system should also use the constraint function of preventing anyone from taking out two transceivers simultaneously. Allowing more than one at a time to be taken simply increases the probability of such transposition.



See also our April 1, 2008 Patient Safety Tip of the Week “Pennsylvania PSA’s FMEA on Telemetry Alarm Interventions” which discussed the Pennsylvania Patient Safety Authority advisory “Alarm Interventions During Medical Telemetry Monitoring: A Failure Mode and Effects Analysis”.







ECRI PSO. Patient Safety E-Alerts. Patient Identification Prevents Life-Threatening Events. Did you Double-Check the Cardiac Monitor? May 2011




Pennsylvania Patient Safety Authority. Patient Safety Advisory supplement “Alarm Interventions During Medical Telemetry Monitoring: A Failure Mode and Effects Analysis”. March 2008





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More Problems With Methotrexate



A year ago we did a column on dangerous incidents involving methotrexate (see our July 2010 What’s New in the Patient Safety World column Methotrexate Overdose Due to Prescribing Error”). In that column we described a lawsuit alleging that an elderly patient with rheumatoid arthritis was erroneously prescribed a methotrexate dose on a daily basis instead of the weekly basis for which it was intended. The erroneous dosage was apparently also then continued when the patient was transferred to a longer term care facility. We had seen that exact scenario in the past. And, in fact, ISMP did a Medication Safety Alert on this issue back in 2002 and another alert in 2009.


Now the Pennsylvania Patient Safety Authority has reviewed 6 years worth of incidents in Pennsylvania involving methotrexate errors. The PPSA advisory found over 200 reports of incidents involving methotrexate in Pennsylvania. Wrong dosage accounted for about a third of these incidents and of those with overdosage almost 60% involved confusion between daily dosing vs. dosing intended to be given only once or twice a week.


Methotrexate is used for treating a variety of conditions. In some, for example oncology conditions, it might be used daily. But for others, such as rheumatoid arthritis where it is used as an immunomodulating agent, it is usually given weekly. The errors often occur during the medication reconciliation process. Typically, methotrexate is initially prescribed by a specialist. But the patient is then admitted to either an acute care hospital or a long-term care facility and the dose is mistakenly written as a daily rather than weekly dose.


ISMP had some good recommendations in their 2002 alert. They recommend use of alerts in electronic prescribing systems and pharmacy computer systems to flag orders written for daily methotrexate to be reviewed for correctness. (This, by the way, is a great example where systems mandating entry of the indication for a drug could be very useful.). They also caution that computer systems should avoid default daily regimens for methotrexate. They recommend the pharmacist should do a prospective review before the medication is dispensed, including checking the indication for the drug, the dosage, the dosing schedule, the appropriate monitoring, and the appropriate education of the patient and caregivers. They also recommend that there be outpatient counseling of patients and that outpatient pharmacies should flag the medication so that this counseling takes place when the patient comes in to pick it up. They also recommend that the instructions on the label specify which day of the week the patient should take the methotrexate and the patient should be educated about what to do in the event of a missed dose. Be especially careful that any printed materials provided for patients have the correct weekly wording. Be particularly careful in cognitively impaired patients. Using dose packs may also reinforce the weekly dosing regimen. For those patients discharged from the hospital on methotrexate, ISMP recommends a followup phone call a day or two after discharge to ensure the patient is taking the methotrexate (and other medications) correctly.


We also think that the patient in a long-term care facility is especially vulnerable. In such cases, the original order for methotrexate is usually written by a specialist. The patient is then followed in the LTC facility typically by a primary care physician who may be less knowledgeable about the particular use of methotrexate for that condition. Also, the LTC patient may not be seen by a physician for periods as long as a month. So if a medication reconciliation error has occurred and a patient intended for once or twice weekly dosing is now on daily dosing, the opportunity for toxicity is greatly increased.







Roche WF. Lawsuit claims dosage error at UPMC Passavant led to death. Pittsburgh Tribune-Review. June 10, 2010




ISMP. Beware of erroneous daily oral methotrexate dosing. ISMP Medication Safety Alert. Acute Care Edition. April 3, 2002 issue




ISMP. Methotrexate Overdose. ISMP Medication Safety Alert. Acute Care Edition. April 23, 2009 issue




PPSA. Data Snapshot: Errors Involving Methotrexate. Pa Patient Saf Advis 2011; 8(2): 77-9






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And Digoxin Hasn’t Gone Away Either



We don’t use digoxin nearly as much as we did 30 years ago. But there are still a few indications for it. It is still often used for rate control inpatients with rapid atrial fibrillation and there remain a few patients in who its inotropic effect is just enough to produce some symptom relief in intractable heart failure.


Nevertheless, the biggest problem with digoxin has always been its relatively narrow therapeutic window. And changes in renal function make patients, particularly the elderly, more vulnerable to toxic effects of digoxin.


ISMP Canada issued a safety bulletin on digoxin recently. They had 414 reports involving digoxin in the past 10 years. Of these, 7 were associated with death and another 11 with patient harm. Incorrect dose was involved in most of the deaths and many of the cases with harm.


One example they provided was an order for “digoxin 0.25 mg orally daily” in which the “2” was mistaken by the pharmacist as a “7” and the patient was dispensed 0.75 mg daily, eventually developing digoxin toxicity. In the case the pharmacist did apparently consult a drug information resource and saw that a dose of 0.75 mg was used during rapid digitalization so misinterpreted that dose as appropriate for daily use. (Note: we’ve seen similar cases with other drugs in which the pharmacist recognizes an unusually high dose of a drug and assumes that is a loading dose without contacting the physician for clarification. This is an example of confirmatory bias where we use information that confirms our mental model but ignore information that does not conform with our mental model. Or it may be an example of “filling in the gaps” where we often assume things subconsciously that turn out to be incorrect.)


ISMP Canada has several recommendations to help avoid such problems with digoxin. They recommend using clinical decision support tools (alerts) to flag for the prescriber cases in which the ordered dose is outside usually prescribed ranges or to flag cases where impaired renal function may call for a reduced dose. Since digoxin also interacts with a variety of drugs, they recommend computerized order entry systems also provide alerts for such drug-drug interactions. They stress the importance of monitoring in patients on digoxin, not only for digoxin levels but also for hypokalemia, which may lower the threshold for digoxin toxicity. They note that patients on drugs that may promote hypokalemia (diuretics, steroids, etc.) may need more frequent monitoring. They also recommend good patient education, including teaching patients how to monitor their heart rate. And they note that many hospitals already require independent double checks for IV digoxin administration or use in pediatrics.







ISMP Canada. Medication Incidents Involving Digoxin Leading to Harm, Including Death. ISMP Canada Safety Bulletin 2011; 11(3): 1-3 April 30, 2011






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First Thoughts on Dabigatran


For years we have waited for safer anticoagulants to help us manage problems like atrial fibrillation. Warfarin has always been on our Top 10 list of high alert medications. Though the efficacy of warfarin in preventing stroke in patients with atrial fibrillation has been well documented, there is still tremendous underutilization when clearcut indications are present. The reason(s): the hassle for both the patient and physician and the dangers of bleeding complications. So the introduction of newer agents to address those concerns has been widely heralded.


One of the first such drugs to achieve FDA approval has been dabigatran. The FDA approved dabigatran in 2010 for prevention of stroke in patients with atrial fibrillation. The approval was based on results of the RE-LY trial (Connolly 2009), which showed that dabigatran reduced the risk of stroke compared to warfarin and had no higher risk of major bleeding.


But like all newly introduced drugs, there typically follows a number of reports of side effects and other untoward consequences that appear when the drug is used in real world settings as opposed to the relatively controlled environment of clinical trials.


Already some reports are coming in about unexpected consequences. A look-alike/sound-alike (LASA) issue has arisen between the brand name of dabigatran (PRADAXA) and brand name clopidogrel (PLAVIX) (ISMP Canada 2011). In that case report, the patient received Pradax 150 mg. daily instead of the intended Plavix 150 mg. daily. The similarity was further confounded by the fact that the dose prescribed was 150 mg., a dose that could apply to either drug. Fortunately, the error was picked up before any harm came to the patient. But you can bet that this particular LASA error is likely to be repeated many times over. We would certainly anticipate that a TALLman lettering convention will be developed for this LASA pair of drugs but won’t make our own suggestion. Typically, an organization like ISMP will mock up a few potential TALLman solutions and make sure they don’t conflict with other existing ones, then do a survey to see which solution works best.


In RE-LY, the rates of major bleeding overall were similar for dabigatran and warfarin. However, for patients aged 75 and older the rate of intracranial bleeding was lower with dabigatran but the rate of extracranial bleeding was higher (Eikelboom 2011). Since many of the patients at highest risk for stroke from atrial fibrillation are in this age group, we may well see more frequent extracranial hemorrhages (primarily GI bleeds) in the elderly. The major concern is that there is currently no known antidote for reversing the effect of dabigatran (unlike warfarin which can be reversed with vitaimin K).


Also, the dabigatran dose must be adjusted in patients with renal dysfunction. ISMP reported a case in which a patient with stage IV CKD received a standard dose of 150 mg twice daily rather than the recommended 75 mg twice daily and developed a serious GI bleed (ISMP 2011). Having rules-based alerts for renal dosing during CPOE obviously would help avoid this sort of incident.


So we don’t know what the bleeding rates are likely to be in a real-world setting. Also, as pointed out in an editorial (Avorn 2011) on a cost-effectiveness study of dabigatran (Shah 2011), we use the INR to assess whether patients on warfarin are in the therapeutic range or not but with dabigatran we have no test to tell us whether the patient is over- or under-anticoagulated. Avorn also notes it is likely that patient adherence to dabigatran is likely to be lower because of its twice daily dosing and its cost, so the stroke rate is likely to be higher than in RE-LY.


Also, we know that warfarin has always been underutilized for patients with atrial fibrillation. We predict that many physicians previously reluctant to use it (for the reasons noted earlier) may now be less reluctant to prescribe the newer agents. The direct-to-consumer advertising that has already hit the media will also likely increase the number of patients being treated with dabigatran. So you can expect to see complications of treatment more often.







Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-1151




ISMP Canada. Drug Name Alert: Potential for Confusion between Pradax and Plavix.

ISMP Canada Safety Bulletin 2011; 11(4): 1-2 May 27, 2011




Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial Fibrillation. An Analysis of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) Trial. Circulation. 2011;123:2363-2372; published online ahead of print May 16, 2011 and again May 31, 2011




ISMP. Adjust Pradaxa dose for renal impairment. ISMP Medication Safety Alert. Community/Ambulatory Care Edition. February 2011 issue




Avorn J. The relative cost-effectiveness of anticoagulants: Obvious, except for the cost and the effectiveness. Circulation 2011; 123:2519-2521




Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation 2011; 123:2562-2570.






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NQF Adds 4 Events to Serious Reportable Events List



The National Quality Forum (NQF) has just updated its list of serious reportable events. The new list contains updates to the 25 events appearing on previous lists and adds four new events.


The four new events are:

·        Death or serious injury of a neonate associated with labor and delivery in a low-risk pregnancy.

·        Death or serious injury resulting from irretrievable loss of an irreplaceable biological specimen.

·        Death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.

·        Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area.



We are pleased to see the new additions, particularly the third one. We have harped on the issue of test results slipping through the cracks in numerous columns, most recently in our June 14, 2011 Patient Safety Tip of the Week Failure to Follow Up”.  And, in keeping with our mantra “stories, not statistics” we’d be remiss if we didn’t point you to a great case discussion of tests falling through the cracks (Schiff 2011). In that discussion, part of JAMA’s Clinical Crossroads series, Gordon Schiff looks at the case from the perspectives of the patient, physicians, hospitals and especially systems. When you read this article you will find yourself saying “that could have happened to me” (either as a patient or physician!).


Note that the new NQF  list also now better reflects the many different venues in which patients receive care and the fact that adverse events often cross organizational boundries. Whereas historical focus has always been on events taking place in hospitals, it is now clear that serious events often occur in the outpatient setting. A recent analysis (Bishop 2011) of malpractice claims paid showed that about half of all claims paid were for events taking place outside the hospital and that major injury or death were the most common outcomes in both settings in these claims. While surgical events accounted for the most common inpatient events, diagnostic errors or failures were the most common reasons on the outpatient side.






NQF. Press Release: NQF Releases Updated Serious Reportable Events. June 13, 2011





Bishop TF, Ryan AK, Casalino LP. Paid Malpractice Claims for Adverse Events in Inpatient and Outpatient Settings.  JAMA 2011; 305(23): 2427-2431




Schiff GD. Medical Error. A 60-Year-Old Man With Delayed Care for a Renal Mass.

JAMA 2011; 305(18): 1890-1898






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AAP Policy Statement: Principles of Pediatric Patient Safety



The American Academy of Pediatrics (AAP) has just published a policy statement on patient safety: Principles of Pediatric Patient Safety: Reducing Harm Due to Medical Care. It is an update of several prior position statements that focuses on (1) the significance of patient safety (2) the science behind the culture of safety and (3) patient safety strategies.


It points out some of the characteristics of children that make them more prone to things like medication errors and the fact that many of the interventions which have been successful in adults have not always been successful in the pediatric population.


It  begins with a discussion of the epidemiology of pediatric patient harm and cites statistics about medication errors in the NICU and pediatric ED settings.


It then goes on to discuss the culture of patient safety and human factors concepts and to discuss key strategies pediatricians need to take in improving pediatric patient safety. They stress the need for pediatric clinicians to assume leadership roles in developing systems of safety and disseminating best practices and the role of technology in patient safety. They discuss specific patient safety goals and provide a variety of  resources that may helo achieve those goals.





American Academy of Pediatrics Steering Committee On Quality Improvement And Management And Committee On Hospital Care. Policy Statement—Principles of Pediatric Patient Safety: Reducing Harm Due to Medical Care.

Pediatrics 2011; peds.2011-0967; Published online May 29, 2011





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Print “July 2011 What's New in the Patient Safety World (full column)

Print “July 2011 ECRI Alert on Patient Identification and Cardiac Monitors

Print “July 2011 More Problems With Methotrexate

Print “July 2011 And Digoxin Hasn’t Gone Away Either

Print “July 2011 First Thoughts on Dabigatran

Print “July 2011 NQF Adds 4 Events to Serious Reportable Events List

Print “July 2011 AAP Policy Statement: Principles of Pediatric Patient Safety













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