What’s New in the Patient Safety World

September 2012



·        Obstructive Sleep Apnea in Stroke Patients

·        Canadian Paediatric Adverse Events Study

·        Good News on Medication Reconciliation

·        Joint Commission Sentinel Event Alert on Opioids

·        FDA Warning on Codeine Use in Children Following Tonsillectomy




Obstructive Sleep Apnea in Stroke Patients



A variety of complications may occur in patients with acute stroke. Aspriation pneumonia, UTI, decubiti, contractures, DVT and pulmonary embolism are some of the more common complications. Because patients with stroke also share numerous risk factors for coronary artery disease, they may also be susceptible to myocardial ischemia and arrhythmias. But we also see some patients who unexpectedly die suddenly after stroke without good explanation. Some have speculated on the possible role of sleep apnea in such cases.


A new study (Aaronson 2012) assessed use of nocturnal pulse oximetry to screen for sleep apnea in stroke patients in an acute rehabilitation setting. They performed both nocturnal oximetry and polysomnography on 56 stroke patients and found a 46% prevalence of sleep apnea syndrome in those patients. Patients with sleep apnea were older, more likely to be male, and had higher BMI’s than those without sleep apnea. But subtype of stroke, stroke location, and degree of disability did not correlate with sleep apnea.


The oxygen desaturation index (ODI) on nocturnal pulse oximetry did correlate very well with the apnea-hypopnea index (AHI) on polysomnography. And the sensitivity, specificity, and positive and negative predictive values of nocturnal oximetry for sleep apnea were quite good. In fact, in a multiple regression model the ODI was the sole predictor of sleep apnea. For an ODI cutoff of 15 or more the sensitivity of nocturnal oximetry was 77%, specificity 100%, and positive predictive value 100% for sleep apnea. A negative result lowered the chance of sleep apnea to 17%.


Since polysomnography may not be readily available or convenient in many settings rendering care for stroke patients, nocturnal oximetry seems to be a reasonable way of identifying patients with likely sleep apnea. Even if such patients are not begun on treatments such as CPAP, knowing they likely have sleep apnea should lead to avoidance of certain medications (opioids, sedative/hypnotics, etc.) that may exacerbate sleep apnea. It might also have implications for positioning of patients during sleep (since many sleep apnea patients do worse when supine).


Obviously, more work needs to be done in determining best practices for handling sleep apnea in stroke patients. But this study certainly highlights the scope of the problem and should spur such further work.






Aaronson JA, van Bezeij T, van den Aardweg jg, et al. Diagnostic Accuracy of Nocturnal Oximetry for Detection of Sleep Apnea Syndrome in Stroke Rehabilitation. Stroke 2012; first published on July 19 2012 as doi:10.1161/STROKEAHA.112.665414






Print “September 2012 Obstructive Sleep Apnea in Stroke Patients





Canadian Paediatric Adverse Events Study



Estimates of rates of adverse events in hospitals depend on the methodology used. Manual chart reviews are cumbersome, time-consuming and labor-intense and grossly underestimate actual rates of adverse events. Use of trigger tools may help the process by identifying charts likely to have associated adverse events. The IHI Global Trigger Tool methodology is “doable” with limited resources and provides a more reliable comparison of adverse events over time. See our October 30, 2007 Patient Safety Tip of the Week “Using IHI's Global Trigger Tool” and our April 15, 2008 Patient Safety Tip of the Week Computerizing Trigger Tools” for more details on how to use it.


Our May 2011 What’s New in the Patient Safety World column “Just How Frequent Are Hospital Medical Errors?” highlighted a study using IHI’s Global Trigger Tool to identify hospital adverse events (Classen 2011) that found that the rates of adverse events may be 10-fold higher than what was noted in the IOM report


Now a new study using a similar trigger tool assessed rates of adverse events in hospitalized pediatric patients in Canada (Matlow 2012). They used the Canadian Paediatric Trigger Tool, a validated tool similar to the IHI Global Trigger tool to identify charts for review in 8 academic pediatric medical centers and 14 community hospitals. The overall rate of adverse events was 9.2%. The overall rate of adverse events was almost 3 times higher in the academic centers but this was largely driven by a higher rate of non-preventable adverse events. Preventable adverse events occurred with roughly the same frequency in both settings. Surgery-related events predominated overall and were more common in the academic centers, whereas diagnostic errors were less frequent in academic centers.


The authors conclude that there are many opportunities to reduce harm affecting children in hospitals, particularly related to surgery, intensive care and diagnostic error.






Classen D, Resar R, Griffin F, et al. ‘Global Trigger Tool’ Shows That Adverse Events In Hospitals May Be Ten Times Greater Than Previously Measured. Health Affairs 2011; 30(4): 581-589




Matlow AG, Baker GR, Flintoft V, et al. Adverse events among children in Canadian hospitals: the Canadian Paediatric Adverse Events Study. CMAJ 2012; July 30, 2012 First published July 30, 2012, doi: 10.1503/cmaj.112153

July 30, 2012






Print “September 2012 Canadian Paediatric Adverse Events Study





Good News on Medication Reconciliation



After a series of articles with not-so-good conclusions regarding medication reconiciliation, we’ve finally seen some good news. First, a recent large randomized clinical trial (Kripalani 2012) showed that over 50% of patients with cardiac conditions discharged from hospitals had one or more clinically significant medication errors and that a health-literacy–sensitive, pharmacist-delivered intervention did not reduce post-discharge medication error rates. Then a recent systematic review of medication reconciliation practices in hospitals (Mueller 2012) highlighted the relative paucity of high quality evidence supporting best practices for medication reconciliation. They concluded that the best evidence supports use of pharmacy staff in the medication reconciliation process and targeting high-risk patients. But for most other approaches, there is a relative paucity of evidence demonstrating desired outcomes.


But a new study from Johns Hopkins (Feldman 2012) has more promising news using a nurse-pharmacist team to do medication reconciliation. They found that a dedicated nurse interviewing the patient and/or contacting the patient’s PCP or pharmacy or reviewing the EMR was able to identify unintended discrepancies from the home medication list compiled by the physician on admission in almost 50% of patients. The nurse would then discuss those discrepancies with a consulting pharmacist and the physician to come up with the best medication list. Such discrepancies were slightly less common on discharge but those found on discharge had higher risk of causing harm to the patient. They provided a cost analysis of the program and concluded that it cost about $32 per patient or $114 to uncover one potentially harmful discrepancy. Using a figure from the literature of $9300 to manage each case with harmful events, they conclude that the program justifies itself financially many times over.


An editorial accompanying the Mueller review (Kaboli 2012) reinforces that targeted interventions are probably most cost-effective.  They advocate for targeting highest-risk patients for medication reconciliation but note the need to balance this against the need to provide safe medication practices for all patients.


There is more to medication reconciliation that just identifying what medications the patient is taking at home. One field we commonly see missing on medication reconciliation forms is “time last dose taken”. While that may be less relevant for drugs like daily statins, it is very relevant for drugs like insulin, anticoagulants, or cardiovascular medications that affect blood pressure or heart rate. Add to that the nuances of various hospital pharmacy dispensing systems that relate time of the order to time a medication may be given. For example, some hospitals might dispense/administer their “once daily” medications every morning at 8:00 AM. In such cases, a patient admitted at 8:30 AM may not get his/her dose of that medication until 8:00 AM the following morning. In the old days a physician would handwrite orders and given them to a nurse who would often ask “do you want the patient to get a dose today?”. Nowdays, with CPOE that step is often lost and there may be no warning on the CPOE system that such medications won’t be given until the next morning.






Feldman LS, Costa LL, Feroli ER, et al. Nurse-pharmacist collaboration on medication reconciliation prevents potential harm. J Hosp Med 2012; 7(5): 396-401




Mueller SK, Sponsler KC, Kripalani S, Schnipper JL. Hospital-Based Medication Reconciliation PracticesA Systematic Review. Arch Intern Med. 2012; 172(14): 1057-1069




Kaboli PJ, Fernandes O. Medication ReconciliationComment on “Hospital-Based Medication Reconciliation Practices”. Arch Intern Med. 2012; 172(14): 1069-1070




Kripalani S, Roumie CL, Dalal AK, et al. Effect of a Pharmacist Intervention on Clinically Important Medication Errors After Hospital Discharge: A Randomized Trial

Ann Intern Med 2012; 157(1): 1-10






Print “September 2012 Good News on Medication Reconciliation






Joint Commission Sentinel Event Alert on Opioids



The Joint Commission has just released Sentinel Event Alert Issue 49: Safe use of opioids in hospitals. In their review of sentinel events related to opioids 47% were due to wrong doses and 29% to improper monitoring. They note that the risk of respiratory depression due to opioids is likely greater than reported, that higher opioid doses are often involved, and that there are various risk factors that predispose certain patients to the respiratory depressant effects of opioids. We’ve outlined the latter in our numerous articles on opioids and respiratory depression (see list at end of today’s column) but the new alert provides a nice table of those risk factors.


Recommendations include:

·        Screening for respiratory depression risk factors

·        Assess prior history of use and abuse, tolerance or intolerance, etc.

·        Do full body search for fentanyl patches or other opioid delivery devices

·        Use multimodal treatment when possible to minimize use of opioids

·        Be very wary in opioid-naïve patients; consider starting with low doses and titrating

·        Use pharmacists or pain management staff when converting between drugs or switching mode of delivery

·        Be particularly careful during transitions of care or patient transport

·        Both pulse oximetry and capnography monitoring should be continuous rather than intermittent

·        Build red flags into CPOE and e-prescribing systems (dose limits, verifications, etc.)

·        Use tall-man lettering for look-alike/sound-alike (LASA) drugs

·        Use dose conversion support systems to help with changes in drug or route of administration

·        Use of PCA with smart pump technology may be helpful


They have good recommendations for staff and patient/family education on opioid use. They also have good recommendations on various tools.



See also our September 2012 What’s New in the Patient Safety World column “FDA Warning on Codeine Use in Children Following Tonsillectomy



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





And we think you’ll learn a lot from our prior articles pertaining to long-acting and/or extended release preparations of opioids:

June 28, 2011              Long-Acting and Extended-Release Opioid Dangers

September 13, 2011     Do You Use Fentanyl Transdermal Patches Safely?

May 2012                    Another Fentanyl Patch Warning from FDA

July 24, 2012               FDA and Extended-Release/Long-Acting Opioids







The Joint Commission. Sentinel Event Alert Issue 49: Safe use of opioids in hospitals. August 8, 2012






Print “September 2012 Joint Commission Sentinel Event Alert on Opioids






FDA Warning on Codeine Use in Children Following Tonsillectomy



The FDA has just issued a safety alert warning on use of codeine in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnea (FDA 2012). This is both timely and very informative and contains some very important information we had not been previously aware of (though many pediatricians may have known).


They issued the alert after reviewing reports in the literature of 3 deaths and one near-miss case of respiratory depression in young children (ages 2-5) following tonsillectomy and/or adenoidectomy for obstructive sleep apnea (Ciszkowski 2009, Kelly 2012). The most interesting facet is the data presented on unusual metabolism of codeine as a root cause. Ingested codeine is converted into morphine in the liver by cytochrome P450 2D6 (CYP2D6). It turns out there are genetic variations that cause some people to be “ultra-rapid metabolizers” which leads to higher concentrations of morphine earlier. Apparently all the children in the above reports were “ultra-rapid metabolizers”.


In the reported cases obstructive sleep apnea (OSA) was the reason for tonsillectomy and/or adenoidectomy. The potiential for a variety of opioids to cause adverse effects in patients with OSA is well known. Ciszkowski et al. point out that as many as a third of young children with obstructive sleep apnea remain symptomatic after adenotonsillectomy (Ciszkowski 2009).


The FDA alert estimates the number of “ultra-rapid metabolizers” as generally 1 to 7 per 100 people, but may be as high as 28 per 100 people in some ethnic groups (the FDA site has a table of these rates by ethnic group). The FDA recommendations for healthcare professionals are:

·        If prescribing codeine-containing drugs, use the lowest effective dose for the shortest period of time on an as-needed basis

·        Counsel parents and caregivers on how to recognize the signs of morphine toxicity, and advise them to stop giving the child codeine and to seek medical attention immediately if their child is exhibiting these signs.

·        Consider prescribing alternative analgesics for children undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome.


The FDA notes there are FDA-cleared tests are available for determining a patient’s CYP2D6 genotype.


The FDA is also investigating whether similar adverse events have been related to codeine use in children having other surgeries or other types of pain.







FDA. FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. 8/15/12




Ciszkowski C, Madadi P, Phillips MS, Lauwers AE, Koren G. Codeine, ultrarapid-metabolism genotype, and postoperative death. N Engl J Med 2009; 361(8): 827-828




Kelly LE, Rieder M, van den Anker J, Malkin B, Ross C, Neely MN, et al. More codeine fatalities after tonsillectomy in North American children. Pediatrics 2012; 129:5 e1343-e1347; published ahead of print April 9, 2012







Print “September 2012 FDA Warning on Codeine Use in Children Following Tonsillectomy











Print “September 2012 What's New in the Patient Safety World (full column)

Print “September 2012 Obstructive Sleep Apnea in Stroke Patients

Print “September 2012 Canadian Paediatric Adverse Events Study

Print “September 2012 Good News on Medication Reconciliation

Print “September 2012 Joint Commission Sentinel Event Alert on Opioids

Print “September 2012 FDA Warning on Codeine Use in Children Following Tonsillectomy













Tip of the Week Archive


What’s New in the Patient Safety World Archive