What’s New in the Patient Safety World

November 2012

 

·        CAUTI Conundrum

·        More on Retained Surgical Items

·        The Mid-Day Nap

·        Beta Blockers Losing Their Luster?

·        More on Safety of Sleep Meds

 

 

 

 

 

CAUTI Conundrum

 

 

Data was recently published regarding the impact of implementation of CMS’ nonpayment policy for hospital-acquired conditions in 2008 (Lee 2012). The authors concluded that the financial disincentive did not lead to lower rates of certain hospital-acquired conditions. Rates for these complications were already declining prior to CMS’ implementation of its reimbursement policy. Specifically, for CLABSI’s there had been a significant 4.8% decline per quarter prior to implementation and 4.7% afterward. For CAUTI’s the preimplementation decline was 3.9% per quarter and only 0.9% per quarter afterward.

 

There are many possible explanations for the slowing of the decline in CAUTI rates. Yes, there may have been some game playing and undoubtedly many patients were getting urinalyses and urine cultures on admission to demonstrate that the UTI was already present on admission. That, of course, means a whole lot of patients also likely received unnecessary treatment for asymptomatic bacteruria. But we think that it simply reflects that we were already targeting CAUTI’s long before CMS implemented their policy.

 

We have long focused on preventing CAUTI’s (see the list below of our multiple prior CAUTI columns) and many organizations had preventive programs in place well before 2008 (though Sanjay Saint and others have noted previously the absence of good programs and practices in many hospitals).

 

But, to complicate matters, Owen et al. (Owen 2012) recently reviewed the relationship between compliance with SCIP measure Inf-9 and CAUTI rates. SCIP Inf-9 is the measure for discontinuation of indwelling urinary catheters within 48 hours in patients undergoing surgery. They found that compliance with SCIP Inf-9 increased substantially over time, reaching about 90%, but that there was no correlation with improved monthly UTI rates. In their analysis they found that CAUTI rates were actually very low in patients in whom the catheter was removed in less than 48 hours. However, most of the UTI’s occurred in patients “exempted” from the measure. In fact, the odds ratio of developing a postoperative UTI was 8 times higher for patients exempted from SCIP Inf-9. While there are a number of reasons a surgeon can specify to qualify for such exemptions, the most common one in this study was presence of an epidural catheter.

 

The authors conclude that the high rate of CAUTI’s in “exempt” patients actually supports continuation of the SCIP Inf-9 measure but that the exemptions need to be modified.

 

While there are undoubtedly some surgeons (and some CFO’s!) who will use these studies to call for elimination of the SCIP Inf-9 measure, we think that continued focus on preventing CAUTI’s is still of great importance from both a patient quality perspective and healthcare cost perspective.

 

When we implement “evidence-based” quality pay-for-performance metrics we sometimes find out later that the evidence was not so strong and we often get unintended consequences. Remember the metric of antibiotics within 4 hours of arrival in the ER for pneumonia patients? That led to numerous patients who turned out not to have pneumonia getting unnecessary antibiotics. It would be interesting to see how many patients got unnecessary antibiotics for asymptomatic bacteruria because of the CMS nonpayment policy for CAUTI’s. If the latter rate is high that might be a reason to change the metric. But continued focus to avoid CAUTI’s is the right thing to do regardless of whether nonpayment policies are in effect or not.

 

But surgeons may not be the only ones paying less attention to CAUTI prevention. Another new study has found that a surprising lack of attention to CAUTI prevention policies and procedures in many ICU’s (Conway 2012). Less than a quarter of ICU’s responding to a survey had policies regarding use of bladder ultrasound or condom catheters. Even fewer used catheter removal reminders or nurse-initiated catheter removal protocols. Ironically, smaller hospitals generally did better than large hospitals in adopting at least one CAUTI prevention strategy.

 

 

 

Our other columns on urinary catheter-associated UTI’s:

 

 

 

 

References:

 

 

Lee GM, Kleinman K, Soumerai SB, et al. Effect of Nonpayment for Preventable Infections in U.S. Hospitals. N Engl J Med 2012; 367: 1428-1437

http://www.nejm.org/doi/full/10.1056/NEJMsa1202419

 

 

Rachel M. Owen RM, Perez SD, Bornstein WA, Sweeney JF. Impact of Surgical Care Improvement Project Inf-9 on Postoperative Urinary Tract InfectionsDo Exemptions Interfere With Quality Patient Care? Arch Surg. 2012; 147(10): 946-953

http://archsurg.jamanetwork.com/article.aspx?articleid=1380450

 

 

Conway LJ, Pogorzelska M, Larson E, Stone PW.  Adoption of policies to prevent catheter-associated urinary tract infections in United States intensive care units. Amer J Inf Control 2012; 40(8): 705-710, October 2012

http://www.ajicjournal.org/article/S0196-6553%2811%2901256-9/abstract

 

 

 

 

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More on Retained Surgical Items

 

 

In our June 12, 2012 Patient Safety Tip of the Week “Lessons Learned from the CDPH: Retained Foreign Bodies” we noted that existing guidelines all stress that the count is not the only important thing. We noted that the count may be correct in 88% of cases of retained surgical items (RSI’s). A recent update by the Pennsylvania Patient Safety Authority (Martindell 2012) also noted that only 22.8% of the RSI’s reported to them in 2011 had an incorrect count.

 

Therefore, it remains critical that the surgeon perform a thorough methodical wound exam in each and every case. It’s also the reason for the ongoing search for technological solutions that might better help prevent retained surgical items.

 

One of the problems in looking at any interventions or technological solutions is how to measure the impact of such in preventing RSI’s. Given the relative rarity of RSI’s, a randomized controlled trial (RCT) using the absolute number of RSI’s as a primary endpoint would require a huge population to demonstrate statistical significance. Such is not likely to be performed. More likely studies will need to look at surrogate measures such as detection rates in cases of discrepant sponge counts

 

Using X-rays to detect potential RSI’s has been used. Using them in all cases would likely be too costly and time consuming. However, many hospitals do use them selectively, requiring them in all high-risk cases (i.e. those cases with many of the risk factors we mentioned in our June 12, 2012 Patient Safety Tip of the Week “Lessons Learned from the CDPH: Retained Foreign Bodies”). But even X-rays are not infallible. Some of the items retained may not be radiopaque. In some cases X-rays may fail to include sufficient exposure or coverage and can miss some RSI’s. A recent case presentation in CMAJ (Grant-Orser 2012) demonstrated an instance where conventional X-ray failed to identify a retained sponge but CT scan did. They go as far as to say that in cases where a discrepant count has occurred and a diaphragm-to-pubis plain radiograph fails to show an RSI, further imaging with CT should be considered.

 

Atul Gawande, who had done some of the seminal work documenting risk factors for RSI’s, and colleagues (Greenberg 2008) did perform an RCT of a system of barcoding surgical sponges. Sponge count discrepancies were detected approximately twice as often using the barcoded technology. The barcoded system did help with things like alerting staff that a sponge had already been accounted for so that it would not get double counted. However, the amount of time required to reconcile discrepant counts and the likelihood of needing an X-ray were unchanged. Some relatively minor technological issues did arise in that study and the total time spent counting sponges was higher in the barcoded arm. Staff satisfaction with the barcoded system was mixed but overall positive. The authors concluded that the barcoded system has the potential to meaningfully reduce the risk of retained sponges but cautioned that the effects on workflow and potential introduction of some new technology related problems must be taken into consideration.

 

And just within the last month a couple new studies were published assessing the usefulness of radiofrequency detection systems to help prevent retained sponges. One was a prospective trial involving almost 2300 patients undergoing a variety of surgical procedures (Rupp 2012). Though they had no RSI’s during the study, the radiofrequency system did assist in the resolution of one near-miss not detected by manual counting and it assisted in the resolution of 35 sponge miscounts.

 

The other study (Steelman 2012) compared a standard radiofrequency detection system with a new radiofrequency “mat”. In a conventional RF detection system an RF chip is embedded in the fabric of the sponges and a wand is passed over the patient, triggering an alarm if a sponge with a chip is detected. The process is somewhat dependent upon good technique by the person passing the wand. The other system involves using a special RF mat that is placed beneath the patient on the operating table. When you want to see if there is a retained sponge in the patient you push a button and the mat does the scanning. The concept is that it takes away the potential human variability in scanning. They studied both systems in 203 patients, of whom 55 (27%) were morbidly obese (BMI greater than 50). They placed tagged sponges on top of the patients, one sponge over each abdominal quadrant. Overall, the RF mat detected 98.1% of the sponges. The only sponges not detected were in morbidly obese patients (i.e. the mat detected 100% of sponges in patients with BMI’s less than 50). Of morbidly obese patients, the mat still detected 96.9% of sponges. There were no false positives. Then, in a subset of patients, they repeated the testing using the hand-held wand and found the sponges in 100% of cases. Thus the RF wand system outperformed the RF mat system, even in the very obese patients. The study also confirmed that a variety of objects on patients, like jewelry and adornments, did not cause false positive detections.

 

Keep in mind that these systems do not detect all potential RSI’s. While the barcoding and RFID systems could track and identify those items that have an appropriate barcode or RFID chip, such as sponges, they would not detect things like needles and broken pieces of equipment or tools. Whole tools could be either barcoded or radiofrequency labeled. However, the issues of how durable such would be when these tools must undergo repeated sterilization procedures remain unanswered.

 

The CMAJ paper (Grant-Orser 2012) has a table listing the published sensitivities of the various detection methods. They note the sensitivity of manual counting is 62-88%, selective radiographic screening 85.8%, universal radiographic screening 95.5%, CT scanning 61%, barcoded sponges 97.5%, and radiofrequency-tagged sponges 100%. Note that those sensitivities were all obtained in different scenarios so they may not actually be apples-to-apples comparisons. They reinforce some of the issues we mentioned above such as increased time involved, introduction of new technological issues, etc.

 

The bottom line: we don’t yet know what the best technological solution is to the retained surgical item problem. None is yet perfect and each has its own set of problems. So for the time being you are stuck with well-done manual counts and perhaps using one of the other technologies as an adjunct. But you can certainly expect refinements to these technologies going forward that may improve our ability to better prevent RSI’s.

 

 

References:

 

 

Martindell D. Update on the Prevention of Retained Surgical Items. Pa Patient Saf Advis 2012; 9(3): 106-110

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Sep;9%283%29/Pages/106.aspx

 

 

Greenberg CC, Diaz-Flores R, Lipsitz SR, et al. Bar-coding Surgical Sponges to Improve Safety: A Randomized Controlled Trial. Annals of Surgery 2008; 247(4): 612-616, April 2008

http://journals.lww.com/annalsofsurgery/Abstract/2008/04000/Bar_coding_Surgical_Sponges_To_Improve_Safety__A.7.aspx

 

 

Grant-Orser A, Davies P, Singh SS. Cases: The lost sponge: patient safety in the operating room. CMAJ 2012; 184: 1275-1278 August 7, 2012

http://www.cmaj.ca/content/184/11/1275.full

 

 

Rupp CC, Kagarise MJ, Nelson SM, et al. Effectiveness of a Radiofrequency Detection System as an Adjunct to Manual Counting Protocols for Tracking Surgical Sponges: A Prospective Trial of 2,285 Patients. J Am Coll Surg 2012; 215: 524-533

http://www.journalacs.org/article/S1072-7515%2812%2900489-9/abstract

 

 

Steelman VM, Alasagheirin MH. Assessment of Radiofrequency Device Sensitivity for the Detection of Retained Surgical Sponges in Patients With Morbid Obesity. Arch Surg. 2012; 147(10): 955-960

http://archsurg.jamanetwork.com/article.aspx?articleid=1380459

 

 

Macario A, Morris D, Morris S. Initial Clinical Evaluation of a Handheld Device for Detecting Retained Surgical Gauze Sponges Using Radiofrequency Identification Technology. Arch Surg 2006; 141(7): 659-662

http://archsurg.jamanetwork.com/article.aspx?articleid=398733

 

 

 

 

 

 

 

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The Mid-Day Nap

 

 

We’ve done multiple prior columns on the impact of fatigue, shiftwork, etc. on both patient outcomes and adverse personal events for workers themselves (see our November 9, 2010 Patient Safety Tip of the Week “12-Hour Nursing Shifts and Patient Safety” and our April 26, 2011 Patient Safety Tip of the Week “Sleeping Air Traffic Controllers: What About Healthcare?”).

 

In those 2 columns and our January 2012 What’s New in the Patient Safety World column “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety” we had extensive discussions about the value of naps and “power naps” as strategies to minimize the effects of healthcare worker fatigue in those working long shifts or night shifts.

 

Now a new study (Amin 2012) has looked at the potential impact of a short mid-day nap on alertness and cognitive functioning in internal medicine housestaff. They hooked up the residents to portable sleep monitoring devices as they arrived for a shift at 8 AM. Slow eye movements (SEM’s), a measure of attention failure, were recorded throughout the day. At about 1 PM residents returned to a quiet room where they were given a test measuring cognitive functioning (Conner’s Continuous Performance Test) and then were either allowed to take a 20-minute (maximum) nap or simply rest without sleeping for 20 minutes. The CPT test was repeated after the 20-minute period and the residents returned to work and their SEM’s continued to be recorded until about 4:30 PM. The group that took the naps had fewer attention failures later in the day and performed better on the cognitive test than the group that just rested without actually napping. This was a very small study (29 residents in total) and did not control for potential confounders like caffeine use or patient load. It also did not have any measure of patient care or safety. Nevertheless, it does lend further credence to the concept of the power nap as a strategy to reduce the potential impact of fatigue in healthcare workers.

 

The Amin article also nicely summarizes some of the known and hypothesized physiology of sleep that may be involved, including mechanisms that might explain why such a short nap would result in improved alertness and cognition. Short naps also are typically not associated with the phenomenon of “sleep inertia” that is often seen after one wakens from a long nap.

 

So it is fairly clear that multiple different types of healthcare workers can benefit from short naps or power naps. The Joint Commission Sentinel Event Alert on Healthcare Worker Fatigue and Patient Safety reminds us we must provide the proper environment (including ensuring staff are truly going to be allowed to nap without interruptions) for naps or sleep breaks. In two of our prior columns we highlighted the work of Geiger-Brown and colleagues (Geiger-Brown 2010) and Fallis and colleagues (Fallis 2011) related to napping strategies for nurses and noted that putting systems in place to allow napping on the night shift is not easy. First, you have to provide adequate “relief” staffing to ensure full coverage of your units at all times. You already must do this for other breaks (meal breaks, bathroom breaks, etc.) that nurses need on any shift. Most nurses will tell you they often work shifts with no breaks at all because of staffing shortages or mismatches between staffing and patient acuity. Second, you need to provide an appropriate physical environment conducive to taking a brief nap (quiet and comfortable, free from interruptions, yet close enough for the nurse to be aroused to respond to patient care emergencies). Third, you need to have in place a system of prioritization in which naps would be allowed only if all preset criteria are met. And lastly you need to have in place a management culture that recognizes the problem as real and is supportive of efforts to address the problem rather than approach it in a punitive manner.

 

Many (or most) nurses and physicians also have difficulty napping if they have one or more patients who are unstable. One other barrier mentioned by several nurses in the Fallis study was fear of what the public would think about nurses “napping on the job”. It is clear that raising public awareness about the dangers of fatigue and the benefits of napping under appropriate circumstances is very important.

 

In the study by Fallis et al. the impact of napping could be positive or negative. Most of the regular nappers noted a positive impact, such as awakening refreshed and able to think more clearly. But naps are not for everyone. One of the downsides of naps is occasionally awakening and temporarily feeling disoriented and slow to respond or the phenomenon of “sleep inertia”. Almost a quarter of the interviewees in the Fallis study mentioned this and it was the primary reason that several of them had become “non-nappers”. The current study by Amin et al. provided some reasonable physiological explanations as to why the 20-minute nap might avoid “sleep inertia”. The Amin study also describes characteristics of the room in which the residents were allowed to sleep and the mechanisms for ensuring they were wakened within the 20-minute timeframe.

 

We are learning more and more about how to use napping strategies to help minimize healthcare worker fatigue and hopefully improve patient safety and patient care.

 

 

 

Some of our other columns on the role of fatigue in Patient Safety:

 

November 9, 2010       12-Hour Nursing Shifts and Patient Safety

April 26, 2011 Sleeping Air Traffic Controllers: What About Healthcare?

February 2011             Update on 12-hour Nursing Shifts

September 2011           Shiftwork and Patient Safety

November 2011           Restricted Housestaff Work Hours and Patient Handoffs

January 2010                Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety

January 3, 2012            Unintended Consequences of Restricted Housestaff Hours

June 2012                    June 2012 Surgeon Fatigue

November 2012           The Mid-Day Nap

 

 

 

 

References:

 

 

Amin MM, Graber M, Ahmad K, et al. The Effects of a Mid-Day Nap on the Neurocognitive Performance of First-Year Medical Residents: A Controlled Interventional Pilot Study. Academic Medicine 2012; 87(10): 1428-1433, October 2012.

http://journals.lww.com/academicmedicine/Abstract/2012/10000/The_Effects_of_a_Mid_Day_Nap_on_the_Neurocognitive.31.aspx

 

 

The Joint Commission. Sentinel Event Alert. Health care worker fatigue and patient safety. Issue #48. December 14, 2011

http://www.jointcommission.org/assets/1/18/SEA_48.pdf

 

 

Geiger-Brown J. Trinkoff AM. Is It Time to Pull the Plug on 12-Hour Shifts? Part 3. harm reduction strategies if keeping 12-Hour Shifts. Journal of Nursing Administration 2010;  40(9): 357-9, 2010 Sep

http://journals.lww.com/jonajournal/Abstract/2010/09000/Is_It_Time_to_Pull_the_Plug_on_12_Hour_Shifts__.4.aspx

 

 

Fallis, WM, McMillan DE, Edwards MP. Napping During Night Shift: Practices, Preferences, and Perceptions of Critical Care and Emergency Department Nurses

Crit Care Nurse March 31, 2011 vol. 31 no. 2 e1-e11

http://ccn.aacnjournals.org/content/31/2/e1.full

 

 

 

 

 

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Beta Blockers Losing Their Luster?

 

 

Many of you have been following the interesting series of articles explaining why some things in medicine sound too good to be true and eventually turn out not to be true or at least not as good as initially thought (Pereira 2012, Ioannidis 2005, Lehrer 2007). Most such studies initially had relatively small numbers and were subject to a number of biases. With time and further attempts at replication the results become much less impressive.

 

Use of beta blockers probably exemplifies that concept as well as anything else in medicine. Back in the 1980’s a number of randomized controlled trials showed that patients suffering acute myocardial infarction (AMI) had a substantial reduction in mortality if they were treated with beta blockers. The mean duration of followup in those studies was a little more than a year. From those studies we extrapolated and began to recommend such patients be continued on beta blockers ad infinitum. Moreover, we also extrapolated the need for beta blockers to patients with coronary artery disease (CAD) but no known MI and even to patients just having multiple risk factors for coronary artery disease.

 

Now researchers using the REACH registry (patients with or at high risk of coronary artery disease followed longitudinally for several years) have looked retrospectively at outcomes of patients in some of the above categories to determine whether beta blockers had an impact (Bangalore 2012). In fact, there was no significant difference in outcomes in the MI cohort for those taking beta blockers and those not taking them. In the CAD without MI cohort there also was no difference. And in the cohort just having risk factors for CAD there was actually a higher rate of adverse events in those patients taking beta blockers. Admittedly this is just an observational study and there are many unanswered questions but these results certainly challenge some longstanding practices. The results support the most recent AHA recommendations for use of beta blockers in patients with acute MI, acute coronary syndrome, and congestive heart failure. But they certainly suggest that many other patients may be inappropriately taking beta blockers.

 

The other controversial area, one which we have addressed on many occasions, is perioperative use of beta blockers. The controversy over perioperative use of beta blockers just won’t go away. We’ve addressed the issue in multiple columns (see Patient Safety Tips of the Week for November 20, 2007 “New Evidence Questions Perioperative Beta Blocker Use” and November 4, 2008 “Beta Blockers Take More Hits”, our December 2009 What’s New in the Patient Safety World column “Updated Perioperative Beta Blocker Guidelines” and our November 2010 What’s New in the Patient Safety World column “More Perioperative Beta Blocker Controversy).

 

After several years in which we pushed for almost universal use of beta blockers perioperatively, publication of the POISE trial significantly changed things. You’ll recall that the POISE trial showed that, though preoperative beta blockers prevented 15 MI’s for every 1000 patients treated, there was an increased risk of stroke and an excess of 8 deaths per 1000 patients treated.

 

Recent revelations regarding potential irregularities in the published works of one of the most prolific researchers in the perioperative beta blocker field have further challenged the perioperative beta blocker picture (Chopra 2012).

 

But there are some studies that demonstrate a continued need to continue beta blockers in patients previously taking them. Our November 2010 What’s New in the Patient Safety World column “More Perioperative Beta Blocker Controversy noted some observational data (Wallace 2010) suggesting that perioperative beta blockade reduces mortality at both 30 days and one year. And that data reinforces that perioperative withdrawal of beta blockers increases mortality. In fact, the Wallace paper showed that beta blocker withdrawal almost quadrupled the 30-day mortality rate and almost doubled the 1-year mortality rate. 

 

Another recent observational study supports the current practice of continuing beta blockers perioperatively in patients who had been taking them prior to their surgery (Kwon 2012). This study, part of a collaborative quality improvement project in Washington state, found that failure to continue beta blockers in patients previously on them almost doubled their rate of adverse events within 90 days after noncardiac surgery.

 

And, to complicate matters even more, another recent study suggests that mortality is reduced in ICU patients with sepsis who had previously been on beta blockers (Macchia 2012).

 

We often joke that one pro-beta-blocker article always engenders another anti-beta-blocker article and vice versa! This year has been no different. Lots of still unanswered questions but these serve as a reminder that sometimes evidence-based medicine turns out to be not so evidence-based.

 

 

 

References:

 

 

Pereira TV, Horwitz RI, Ioannidis JP. Empirical Evaluation of Very Large Treatment Effects of Medical Interventions. JAMA 2012; 308(16): 1676-1684

http://jama.jamanetwork.com/article.aspx?articleid=1386610

 

 

Ioannidis JP. Why Most Published Research Findings Are False. PLoS Medicine 2005; 2(8): e124

http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020124

 

 

Lehrer J. The Truth Wears Off. The New Yorker. December 13, 2007

http://www.newyorker.com/reporting/2010/12/13/101213fa_fact_lehrer

 

 

Bangalore S, Steg G, Deedwania P, et al. β-Blocker Use and Clinical Outcomes in Stable Outpatients With and Without Coronary Artery Disease. JAMA 2012; 308(13): 1340-1349

http://jama.jamanetwork.com/article.aspx?articleid=1367524

 

Chopra V, Eagle KA. Perioperative Mischief: The Price of Academic Misconduct. Amer J Med 2012; 125(10): 953-955

http://www.amjmed.com/article/S0002-9343%2812%2900386-5/abstract

 

 

Wallace AW, Au S, Cason BA. Association of the Pattern of Use of Perioperative ß-Blockade and Postoperative Mortality. Anesthesiology 2010; 113(4): 794-805

http://journals.lww.com/anesthesiology/Fulltext/2010/10000/Association_of_the_Pattern_of_Use_of_Perioperative.11.aspx

 

 

Kwon S, Thompson R, Florencem M, et al. β-Blocker Continuation After Noncardiac SurgeryA Report From the Surgical Care and Outcomes Assessment Program

Arch Surg. 2012; 147(5): 467-473

http://archsurg.jamanetwork.com/article.aspx?articleid=1150110

 

 

Macchia A, Romero M, Comignani PD, et al. Previous prescription of β-blockers is associated with reduced mortality among patients hospitalized in intensive care units for sepsis. Critical Care Medicine 2012; 40(10): 2768-2772, October 2012.

http://journals.lww.com/ccmjournal/Abstract/2012/10000/Previous_prescription_of___blockers_is_associated.4.aspx

 

 

 

 

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More on Safety of Sleep Meds

 

 

In our May 2012 What’s New in the Patient Safety World column “Safety of Hypnotic Drugs” we discussed many of the safety issues related to sedative/hypnotic drugs. They frequently are contributing factors to patient falls, delirium, and opioid-related respiratory depression. Sometimes we’ll see withdrawal syndromes in patients who have been receiving such drugs chronically. They may also play a role in predisposing some patients to aspiration. And they are a frequent contributor to events occurring in patients with sleep apnea. They appear on Beers’ List or other lists of drugs potentially contraindicated in the elderly. Some facilities have made concerted efforts to avoid use of sedative/hypnotics (see our August 2009 What’s New in the Patient Safety World column “Bold Experiment: Hospitals Saying No to Sleep Meds”). And we actively discourage including checkboxes for sleep meds on standardized order sets, whether they are paper-based or electronic (see our March 23, 2010 Patient Safety Tip of the Week “ISMP Guidelines for Standard Order Sets”).

 

And we also discussed a series of papers using data from a large integrated health system documenting an association between hypnotic drugs and mortality. The first paper (Kripke 2012) found the risk for death was about 4.5 times higher in those patients who had been prescribed hypnotics. They found a dose-response relationship where the risk increased with increasing numbers of sleep pills taken. A second paper by the same group and same database found that the risk of death was even higher in the subset of patients having obesity (Langer 2012). The authors speculate about the role of sleep apnea and its interaction with the sleep meds in this population. While these two studies have uncovered an association between mortality and use of hypnotics, they do not confirm a cause-effect relationship.

 

But a new study has challenged the strength of the association between hypnotic use and mortality (Hartz 2012). One key question unanswered in previous studies showing a higher mortality in patients using hypotics was whether sicker or higher risk patients were more likely to use these drugs. The new study used data from the well-known long-term Women’s Health Initiative (WHI) and was able to adjust for a host of other clinical factors. They did note that those women using almost daily hypnotic drugs had a 62% increased risk of mortality. However, after adjusting for a variety of risk factors associated with poor health there was a great attenuation of the relationship between hypnotic use and mortality (adjusted odds ratio 1.14) for those using hypnotics almost daily and the relationship disappeared entirely for those using them less frequently. However, since the study period for the WHI ended in 1998 most women in the study did not take any of the currently used sedative/hypnotic agents that may have been used in the more recent studies.

 

Since our last column there has also been a new study linking hypnotic use with hip fractures in nursing home patients (Berry 2012). This study found that nursing home residents taking the newer non-benzodiazepine hypnotics were 70% more likely to suffer hip fractures. The risks were higher for new users of these drugs and, somewhat surprisingly, were actually higher for those patients with little or no cognitive impairment.

 

Regardless of the strength of the association between hypnotics and these adverse events this should make us all think twice before prescribing hypnotics to anyone. There are multiple non-pharmacologic approaches that should be considered before you would use pharmacologic interventions for insomnia. We need to be doing much more on the outpatient side to reduce use of such drugs. You do, of course, need to consider the possibility of psychiatric conditions (particularly depression and anxiety) as causes for chronic insomnia. But in most cases you need to help patients adopt practices that promote good nocturnal sleep. That includes things like counseling them about eating and drinking habits in relation to time of day (eg. avoiding caffeinated beverages at night or avoiding large volumes of fluid that will lead to awakening to void). And you need to make sure that noise and light levels are not barriers to sleep and that the ambient temperature is conducive to sleep. Similarly, activities earlier in the day may be important. Getting some exercise, particularly outdoors, may benefit sleep as well as overall health. Attention to patterns of any naps may also identify why a patient has trouble sleeping at night.

 

Given the time pressures of outpatient medicine, it’s all too easy to simply write a prescription for a sleep med for your patient. But you’re probably not doing them any favors. The new studies suggest even the occasional use of sleep meds may be harmful. If you don’t have your own program for helping patients adopt non-pharmacological measures to improve their sleep, consider referring them to a sleep medicine specialist. Those specialists do a lot more than treat obstructive sleep apnea. They do comprehensive evaluations of a patient’s sleep and waking patterns and habits and first promote good sleep hygiene habits when approaching the patient with chronic insomnia.

 

 

 

References:

 

 

Kripke DF, Langer RD, Kline LE. Hypnotics' association with mortality or cancer: a matched cohort study. BMJ Open 2012; 2: e000850 doi:10.1136/bmjopen-2012-000850

Published 27 February 2012

http://bmjopen.bmj.com/content/2/1/e000850.full.pdf+html

 

 

Langer RD, Kripke DF, Kline LE. Abstract 052: Short-acting Hypnotic Drugs Increase Mortality and Obese Patients are Particularly Vulnerable. Circulation. 2012; 125: A052

http://circ.ahajournals.org/cgi/content/meeting_abstract/125/10_MeetingAbstracts/A052?sid=6e7368de-3c9c-4a15-8e8d-6baf4b1e1d0b

 

 

Hartz A, Ross JJ. Cohort study of the association of hypnotic use with mortality in postmenopausal women. BMJ Open 2012; 2(5). pii: e001413. http://bmjopen.bmj.com/content/2/5/e001413.long

 

 

Berry S, et al "Risk of hip fracture associated with non-benzodiazepine hypnotics in subgroups of nursing home residents" American Society for Bone and Mineral Research ASBMR 2012; Abstract 1056 as reported by Walsh N. Hip Fractures High with Newer Sleeping Pills. MedPage Today 2012; October 15, 2012

http://www.medpagetoday.com/MeetingCoverage/ASBMR/35311

 

 

 

 

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

Print “November 2012 CAUTI Conundrum

Print “November 2012 More on Retained Surgical Items

Print “November 2012 The Mid-Day Nap

Print “November 2012 Beta Blockers Losing Their Luster?

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