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What’s New in the Patient Safety World

June 2019

 

·       FDA Boxed Warning on Sleep Meds

·       More Spin

·       More on the Time of Day

·       Guidelines for NG Tube Placement

 

 

 

FDA Boxed Warning on Sleep Meds

 

 

We’ve done many columns (see list below) on the unwanted side effects of sleep meds. 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. Some studies have suggested a link between sedative/hypnotic drugs and mortality, hip fractures, and emergency room visits.

 

And that is without going into detail about the anecdotal and sometimes sensationalized stories about someone doing bizarre things at night and having no recall while on sleep meds,

 

But the latter is what finally led to the FDA adding a “boxed warning” to several common prescription insomnia medicines (FDA 2019). While the FDA over the years has included warnings in prescribing information on several sedative/hypnotic drugs, it was these complex sleep behaviors that finally led to the more serious action just taken. Complex sleep behaviors include sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths.

 

According to the FDA, these behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.

 

The FDA notes that serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose. They can also occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.

 

The FDA identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death. Those included 20 cases of death and 46 non-fatal cases (eg, falls, burns, near-drowning, exposure, gunshot wounds, and suicide attempts).

 

In addition to the boxed warning, the FDA will also require a “contraindication”, the agency’s strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.

 

The FDA also repeats its reminder that all medicines taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia medicines, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia medicines can experience decreased mental alertness the morning after use even if they feel fully awake.

 

We hope you’ll take another look at some of our previous columns on safety issues with sleep meds. On the outpatient side, knowing and understanding how to promote good sleep hygiene is extremely important in helping patients avoid the need for such drugs in the first place. 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. And, always try to identify some of the factors that may be causing or contributing to insommia (eg. depression, anxiety, pain, etc.).

 

On the inpatient side, we need to do more to promote sleep but do it more in a non-pharmacological approach and minimize the use of sleep meds. That usually means putting in place various system fixes (eg. removing them from standardized order sets, using clinical decision support tools, etc.) that may help your prescribers use alternatives to sleep meds.

 

And, if your patient is already taking a sleep medication, consider deprescribing it. Our June 2018 What's New in the Patient Safety World column “Deprescribing Benzodiazepine Receptor Agonists” had links to several resources and guidelines on deprescribing these medications.

 

 

Some of our previous columns on safety issues associated with sleep meds and promoting sleep in inpatients:

 

August 2009               “Bold Experiment: Hospitals Saying No to Sleep Meds

March 23, 2010           “ISMP Guidelines for Standard Order Sets

May 2012                    “Safety of Hypnotic Drugs

November 2012          “More on Safety of Sleep Meds

March 2013                 “Sedative/Hypnotics and Falls

June 2013                    “Zolpidem and Emergency Room Visits

August 6, 2013           “Let Me Sleep!

June 3, 2014                 “More on the Risk of Sedative/Hypnotics

May 15, 2018              “Helping Inpatients Sleep

June 2018                    “Deprescribing Benzodiazepine Receptor Agonists

November 6, 2018      “More on Promoting Sleep in Inpatients

 

 

Some of our past columns on deprescribing:

 

·       November 27, 2018 “Focus on Deprescribing

·       March 19, 2019 “Updated Beers Criteria

 

 

References:

 

 

FDA (US Food and Drug Administration). FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines. FDA Drug Safety Communication. FDA 4/30/2019

https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia

 

 

 

 

 

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More Spin

 

 

These results sound too good to be true! Such pronouncements always raise our “hype radar” or “spin radar” (see our February 16, 2010 Patient Safety Tip of the Week “Spin/Hype…Knowing It When You See It”). In that column we noted how results of one clinical trial were “spun” and published in various forms in not one, not two, but three well-respected peer-reviewed medical journals.

 

Khan and colleagues (Khan 2019) recently published a systematic review of published reports of cardiovascular randomized clinical trials (RCT’s) in 6 high-impact medical journals, with a focus on comparing the language in the abstracts, main text, discussion or conclusions against the actual data in the RCT. These were all RCT’s in which the primary outcome of the study failed to reach statistical significance.

 

Spin was identified in 57% of abstracts and 67% of main texts of published articles that met their inclusion criteria. 11% had spin in the title, 38% in the results section, and 54% in the conclusions. Among the abstracts, spin was observed in 41% of results sections 48% of conclusions sections.

 

The authors conclude that, in reports of cardiovascular RCTs with statistically nonsignificant primary outcomes, investigators often manipulate the language of the report to detract from the neutral primary outcomes. They caution all who read such literature be aware that peer review does not always preclude the use of misleading language in scientific articles.

 

There are numerous ways in which the results of a study may be “spun”. Khan and colleagues identified specific spin strategies that were used:

1.     authors pivoted on statistically significant secondary results in the form of focus on within-group comparison, secondary outcomes, subgroup, or per-protocol analyses

2.     authors interpreted statistically nonsignificant results of the primary outcomes to show treatment equivalence or to rule out an adverse event

3.     authors emphasized the beneficial effect of the treatment with or without acknowledging the statistically nonsignificant primary outcome

4.     Strategies of spin that could not be classified under 1 of the 3 schemes were systematically recorded as “other”

 

Perhaps surprisingly, conflicts of interest disclosures of the first authors and last authors did not correlate with spin. Even more surprisingly, it was not associated with industry funding.

 

The accompanying editorial (Fihn 2019) cites the following examples of “spin” in the various sections of a publication as identified by Boutron and Ravaud (Boutron  2018):

Methods misreporting

·       Changing objectives or hypothesis to conform to the results.

·       Not distinguishing prespecified from post hoc analyses.

·       Failing to report protocol deviations.

Results misreporting

·       Selective reporting or focus on outcomes favorable to the study hypothesis, particularly statistically significant results.

·       Disregarding results that contradict initial hypotheses.

Misinterpretation

·       Misleading interpretation (eg, ignoring regression to the mean, confounding, or small effect size).

·       Misinterpreting a significant P value as a measure of effect, or lack of significance as indicative of equivalence or safety.

·       Unfounded extrapolation to a larger population or different setting.

·       Ignoring limitations.

 

In our February 16, 2010 Patient Safety Tip of the Week “Spin/Hype…Knowing It When You See It”) we noted an excellent review on the limitations of randomized controlled trials (RCT’s) that was published in Journal of the American College of Cardiology (Kaul and Diamond 2010). This paper is very good at helping you understand some complicated statistical issues but really emphasizes three points we have often made in the past:

·       Many articles report outcomes that are statistically significant but are of little clinical significance.

·       Post-hoc subgroup analyses are prone to error and inappropriate interpretation and should be used only to generate ideas for futures studies. Otherwise, they may erroneously lead to adoption of practices that are not evidence-based.

·       Use of composite outcomes is especially likely to give rise to inappropriate conclusions when the outcomes are driven by one component of that composite, especially when that component is not as clinically significant as other components.

 

Whenever you read a study published in a journal, even a respected peer-reviewed journal, you must carefully scrutinize the language used and make sure that such language is not at odds with the data presented. And the Khan study, along with the others noted here, put the publishers of all medical journals on notice that it is their responsibility to ensure that results of studies they publish accurately reflect the facts and are not “spun”.

 

 

References:

 

 

Khan MS, Lateef N, Siddiqi J, et al. Level and Prevalence of Spin in Published Cardiovascular Randomized Clinical Trial Reports With Statistically Nonsignificant Primary Outcomes. A Systematic Review. JAMA Netw Open. 2019; 2(5): e192622

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2732330

 

 

Fihn SD. Combating Misrepresentation of Research Findings. JAMA Netw Open 2019; 2(5): e192553 May 3, 2019

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2732324

 

 

Boutron  I, Ravaud  P.  Misrepresentation and distortion of research in biomedical literature.  Proc Natl Acad Sci USA 2018; 115(11): 2613-2619

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5856510/

 

 

Kaul S, Diamond GA. Trial and Error: How to Avoid Commonly Encountered Limitations of Published Clinical Trials. J Am Coll Cardiol 2010; 55: 415-427

http://www.onlinejacc.org/content/55/5/415.abstract

 

 

 

 

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More on the Time of Day

 

 

Most patients try to schedule their medical appointments and elective procedures around times that are convenient for themselves or their families or friends. But does that always result in the best healthcare?

 

Our Patient Safety Tip of the Week for May 3, 2011 “It’s All in the Timing” noted disparities in polyp detection rates for colonoscopies done later in the day. Another study (Kim 2018) Influenza vaccination rates significantly declined as the clinic day progressed. The researchers in that study also developed an active choice intervention in the electronic health record that successfully increased influenza vaccination rates that were similar in magnitude throughout the day. And another study analyzed decisions regarding antibiotic prescribing (Linder 2014). Those researchers found that primary care clinicians’ likelihood of prescribing antibiotics increased throughout the morning and afternoon clinic sessions for antibiotics sometimes indicated and antibiotics never indicated acute respiratory infections. This was consistent with the hypothesis that decision fatigue progressively impairs clinicians’ ability to resist ordering inappropriate treatments. And yet another study found that opioid prescribing for low back pain in primary care increased later in the day (Philpot 2018).

 

Now a new study shows that your chance of receiving cancer screening from your primary care practitioner also depends on what time of day you see him/her. Hsiang et al. (Hsiang 2019) looked at association of primary care clinic appointment time with clinician ordering and patient completion of breast and colorectal cancer screening. They found that clinician ordering of cancer screening tests significantly decreased as the clinic day progressed. Patient completion of cancer screening tests within 1 year of the visit was also lower as the primary care appointment time was later in the day.

 

Screening test order rates for breast cancer were highest at 8 AM at 63.7%, decreased throughout the morning to 48.7% at 11 AM, increased to 56.2% at noon, and then decreased to 47.8% at 5 PM. Trends in screening test completion rates were similar beginning at 33.2% at 8 AM and decreasing to 17.8% at 5 PM.

 

For colorectal cancer screening, test order rates were 36.5% at 8 AM, decreased to 31.3% by 11 AM, increased at noon to 34.4%, and then decreased to 23.4% at 5 PM. Trends in screening test completion rates were similar beginning at 28.0% at 8 AM and decreasing to 17.8% at 5 PM.

 

While fatigue is one obvious explanation for many of these findings, there are other factors that likely contribute. Hsiang et al. noted that, ss each shift progresses, clinicians may fall behind schedule, possibly leading to shorter interactions with the patient at the end of the morning and afternoon shifts. They also note that, if patients earlier in the day decline screening despite the clinician’s recommendation, it could influence how likely the clinician is to bring up the topic later in the day with a different patient. They also note that in this study, and several of the others noted above, behaviors improved slightly after lunch, only to decline again later in the afternoon.

 

In the accompanying editorial (Liss 2019), Liss and Linder note that “decision fatigue” (progressive erosion of ability, self-control, or will power that occurs as people make choices) occurs in several other industries and social situations. But they also note that other factors, like fatigue among ancillary staff (who often are the ones who arrange for preventive care). And there may well be patient factors that come into play. It may be that end-of-the-day patients were less likely to make immediate arrangements for follow-up or remember that they needed follow-up.

 

Whatever the cause(s), it’s important that healthcare organizations institute proper systems to identify such missed opportunities. And it is incumbent upon the astute customer of healthcare to recognize that there are vulnerabilities associated with the time of day they receive their healthcare.

 

 

References:

 

 

Kim RH, Day SC, Small DS, et al.  Variations in influenza vaccination by clinic appointment time and an active choice intervention in the electronic health record to increase influenza vaccination.  JAMA Netw Open 2018; 1(5): e181770

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2702210

 

 

Linder JA, Doctor JN, Friedberg MW, et al. Time of day and the decision to prescribe antibiotics. JAMA Intern Med 2014; 174(12): 2029-2031

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1910546

 

 

Hsiang EY, Mehta SJ, Small DS, et al. Association of Primary Care Clinic Appointment Time With Clinician Ordering and Patient Completion of Breast and Colorectal Cancer Screening. JAMA Netw Open 2019; 2(5): e193403 May 10, 2019

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2733171

 

 

Philpot LM, Khokhar BA, Roellinger DL, et al. Time of day is associated with opioid prescribing for low back pain in primary care. J Gen Intern Med 2018; 33(11): 1828-1830

https://link.springer.com/article/10.1007%2Fs11606-018-4521-8

 

 

Liss DT, Linder JA. Decision Fatigue, Running Late, and Population Health Management—Screening Out of Time. JAMA Netw Open 2019; 2(5): e193402 May 10, 2019

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2733166

 

 

 

 

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Guidelines for NG Tube Placement

 

 

One of our most surprising frequently accessed columns has been our November 1, 2011 Patient Safety Tip of the Week “So What’s the Big Deal About Inserting an NG Tube?”. In that column we noted numerous reports from the UK’s NPSA of incidents and bad outcomes related to NG (nasogastric) tubes and we mentioned some of our own observations.

 

NG tube insertion is viewed by many as a simple and routine procedure. But we have seen NG tubes in patient’s lungs, the pleural space, and even in a cerebral ventricle! So we have a great respect for proper NG tube insertion.

 

Then, our October 2016 What's New in the Patient Safety World column “AACN Alert on Feeding Tube Placement” discussed American Association of Critical-Care Nurses press release (AACN 2016) on their practice alert “Initial and Ongoing Verification of Feeding Tube Placement in Adults”. According to that guideline, the expected practice during the insertion procedure is to use a combination of two or more of the following bedside methods to predict tube location:

But, confirmation by radiography is still the most important element but results of the above elements can be used to determine when it is time to use radiography to confirm tube location and they may also be able to reduce the number of confirming radiographs to one. That alert also stressed that nurses should not use the auscultatory (air bolus) or water bubbling method (holding tube under water) to determine tube location.

 

Now, a new systematic review (Metheny 2019) reviewed guidelines/recommendations to distinguish between gastric and pulmonary placement of nasogastric tubes. The authors identified 14 such guidelines published between 2015 and 2018. Tube placement testing methods included in the review were: radiography, respiratory distress, aspirate appearance, aspirate pH, auscultation, carbon dioxide detection and enteral access devices. All fourteen guidelines agreed that radiography is the most accurate testing method. Of the nonradiographic methods, pH testing was most favored; least favored was auscultation.

 

Regarding the use of radiography for NG tube placement confirmation, recommendations ranged from ‘always required’ to ‘use only when other methods fail’. But they noted that geographical location influenced whether or not radiography was recommended as the first-line method. Whereas US guidelines favor radiographic testing as the first-line method for tube placement determination, those from Europe and Australia often favor radiographic testing only when the pH-method has failed or patients are ‘at risk’.

 

Of course, we always observe the patient for signs of respiratory distress after NG tube placement (eg. coughing, choking, tachypnea, cyanosis, etc.) but that should never be a method of determining tube placement. Patients who are obtunded or neurologically impaired may not have such signs even when the tube is in their lungs.

 

The review discussed that the physical appearance of the NG tube aspirate is not an accurate way of differentiating pulmonary vs. gastric placement. The review then notes considerable variation in the nine guidelines regarding the utility of aspirate pH as a predictor of nonpulmonary placement. Both the reliability of the method and the pH cutoff level vary from guideline to guideline.

 

Five of the guidelines reviewed discussed the efficacy of carbon dioxide detection devices in distinguishing between gastric and pulmonary placement. All five agree that the method is helpful but insufficient as a sole method to distinguish between gastric and pulmonary tube placement.

 

Only one guideline referred to auscultation as being sufficient to determine gastric placement. All the others either said auscultation should not be used at all or was unreliable to be used as the sole method of placement determination.

 

The review also gives little support for use of an enteral access device as a solitary method to distinguish between gastric and pulmonary placement.

 

The report concludes that there is general consensus among the guidelines that a properly obtained and interpreted x-ray is the most accurate method to distinguish between gastric and pulmonary placement of NG tubes.

 

Our 2 previous columns include important considerations for the radiologic confirmation of tube location. Our November 1, 2011 Patient Safety Tip of the Week “So What’s the Big Deal About Inserting an NG Tube?” stressed that particular attention be paid to the x-ray requisition, which should clearly state the x-ray is for determination of tube placement. All too often we still see x-ray requisitions filled out with something like the admission diagnosis rather than the real reason for the x-ray. And you need to make sure that the person doing the interpretation is appropriately credentialed to do so (for example, if someone other than the radiologist is doing the interpretation). And feeding should not be commenced via that tube until the radiologist (or appropriately credentialed person) has documented the tube is in the correct location.

 

Our October 2016 What's New in the Patient Safety World column “AACN Alert on Feeding Tube Placement” noted that correct placement of a blindly inserted small-bore or large-bore tube should be confirmed with a radiograph that visualizes the entire course of the tube prior to its initial use for feedings or medication administration. Once correct tube placement is confirmed, the exit site from the patient’s nose or mouth should be immediately marked and documented to assist in subsequent determinations of tube location. After feedings are started, tube location should be checked at four-hour intervals.

 

Our original column (November 1, 2011 Patient Safety Tip of the Week “So What’s the Big Deal About Inserting an NG Tube?”) had links to the UK’s National Patient Safety Agency reports that detailed many incidents and complications related to improper NG tube placement. It also had links to a video and other resources on proper placement.

 

 

References:

 

 

AACN (American Association of Critical-Care Nurses). Feeding Tubes Require Initial and Ongoing Verification to Minimize Complications. American Association of Critical-Care Nurses updates Practice Alert on feeding tube placement. Press Release 15-Sep-2016

http://www.newswise.com/articles/feeding-tubes-require-initial-and-ongoing-verification-to-minimize-complications

 

 

AACN (American Association of Critical-Care Nurses). AACN Practice Alert: Initial and Ongoing Verification of Feeding Tube Placement in Adults. CriticalCareNurse 2016; 36(2):  e8-e13 April 2016

http://www.aacn.org/wd/practice/content/feeding-tube-practice-alert.pcms?menu=practice

 

 

 

Metheny NA, Krieger MM, Healey F, Meert KL. A review of guidelines to distinguish between gastric and pulmonaryplacement of nasogastric tubes. Heart & Lung 2019; 48(3): 226-235

https://www.heartandlung.org/article/S0147-9563(18)30562-4/fulltext

 

 

 

 

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