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Patient Safety Tip of the Week 

May 22, 2012

Update on Preoperative Screening for Sleep Apnea

We have been advocates for screening for obstructive sleep apnea (OSA) preoperatively (see links to prior columns listed below). This month there are 2 new papers on this topic from Frances Chung and her group in Toronto. One is further validation of the utility of the STOP-Bang questionnaire in predicting OSA. The other is one that looked at simple nocturnal oximetry and found that an oxygen desaturation index (ODI) >10 would predict most cases of moderate and severe OSA (though not good at picking up central apnea). Since delaying surgery to get formal polysomnographic studies might not be feasible in many cases, having alternative means of identifying high-risk patients is very desirable.

The first paper (Chung 2012a) extended their previous work on using the STOP-Bang questionnaire to predict OSA. 746 patients scheduled for inpatient surgery underwent both the STOP-Bang questionnaire and polysomnography (lab-based or home-based). Overall, OSA was present in 68.4% of patients (note that it is highly likely that patients having symptoms of OSA may have been more likely to consent to this study). They then looked at the sensitivities and specificities and positive and negative predictive values of various STOP-Bang scores to predict moderate or severe OSA and concluded that a STOP-Bang score of 5-8 identified a population with a high probability of moderate/severe OSA.

In the second study (Chung 2012b) 475 patients scheduled for inpatient surgery underwent home-base polysomnography and nocturnal oximetry with a wristwatch-based oximeter. Compared to those patients having an oxygen desaturation index (ODI) less than 5, those with an ODI greater than 5 had a significant increase in frequency of sleep disordered breathing. Using a cutoff ODI >10 had a sensitivity of 93% to detect moderate or severe OSA. The nocturnal ODI was not as sensitive in identifying central apnea.

Taking the two studies together leads to a potential strategy for identifying patients with OSA preoperatively without having to do a formal polysomnogram, that is using the STOP-Bang questionnaire followed by nocturnal oximetry in appropriate cases.

Though we don’t know whether CPAP is effective perioperatively in this population (the only study showed no benefit), knowing that someone has OSA has perioperative implications in airway management, opiate and other drug selection, post-op monitoring, pulmonary complications, overall complications and LOS. A previous study (Kaw 2012) found that patients with OSA undergoing cardiac surgery were almost 7 times more likely to have overall complications, 8 times more likely to have postoperative hypoxemia, and over 4 times more likely to require transfer to an ICU. They also had longer lengths of stay. Another study (Memtsoudis 2011) had also shown about a 5-fold increase in respiratory failure in patients with OSA undergoing noncardiac surgery. The latter study showed patients with OSA developed pulmonary complications more frequently than their matched controls after both orthopedic and general surgical procedures.

However, what we need to do now is demonstrate that outcomes can be improved by doing such preoperative screening and then implementing care management programs for this high-risk population.

A recent review of sleep disorders in hospitalized patients (Venkateshiah 2012) describes the physiology of sleep disturbances in this population and the factors contributing to disturbed sleep in the hospital. It also summarizes the ASA recommendations for perioperative management of OSA. Pain is the most common cause of disturbed sleep. One of the key occurrences in the immediate post-surgical period is a suppression of REM (rapid eye movement) sleep. This may be related to factors such as catecholamine levels and treatment with opioids. Then, on the second and third post-op days there is a REM rebound. During this period there is a significant increase in episodic oxygen desaturations due to disordered breathing.

Venkateshiah and Collop go on to summarize the American Society of Anesthesiologists (ASA) practice guidelines for the perioperative management of patients with OSA (ASA 2006). Like other reviews of the perioperative management of patients with OSA (Chung 2008, Adesanya 2010) they readily admit there is a paucity of evidence-based recommendations for care of surgical patients with suspected or known OSA.

There are obviously many reasons to identify patients preoperatively who are at high risk for OSA. Such patients are at greater risk for difficult intubation and are at risk for multiple post-operative complications. Anesthesiologists would like to use local anesthesia or peripheral nerve blocks where appropriate or otherwise use short-acting anesthetic agents in such patients and completely reverse the effects of neuromuscular blocking agents. Avoidance of the supine position as much as possible is recommended since some OSA is position-dependent.

Monitoring of the patient with OSA is obviously a key consideration. But Venkateshiah and Collop are quick to point out that there is a lack of an evidence base that monitoring with either pulse oximetry or capnography improves outcomes in this population.

Our February 22, 2011 Patient Safety Tip of the Week “Rethinking Alarms” highlighted an excellent study by Lynn and Curry (Lynn 2011) who describe 3 patterns of unexpected in-hospital deaths and demonstrate the problems with threshold-based alarms (almost all currently used alarm systems use threshold-based principles) in detecting early deterioration. Indeed, they posit that threshold-based alarms themselves often cause us to miss signs of early deterioration. Even systems using continuous pulse oximetry and end-tidal CO2 monitoring may fail to adequately identify these patients. Nevertheless, we recommend monitoring with oximetry, capnography, and a rate/apnea monitor post-operatively. And while the first 12-hours post-operatively is a vulnerable period, the REM rebound and REM-associated hypoxemic events may increase 3-fold on the second and third postoperative nights, with associated risk of complications. Thus, monitoring should not be stopped before this period

Similarly, most of the recommendations for management of OSA in the post-op patient are consensus recommendations, as there has been a paucity of evidence. So most recommendations remain based on consensus opinion.

In patients with known OSA who are on CPAP at home, it is usually recommended that you have the patient bring in their CPAP machine from home. But in patients with suspected OSA or just recently diagnosed OSA who have not yet been on CPAP the effectiveness of CPAP in the hospital has not been demonstrated. In our November 22, 2011 Patient Safety Tip of the Week “Perioperative Management of Sleep Apnea Disappointing” we noted one of the few randomized controlled studies of surgical patients deemed at high risk of OSA had disappointing results (O’Gorman 2011). That study showed that autotitrating positive airway pressure (APAP) failed to prevent obstructive apnea in surgical patients deemed high risk for the disorder. They did find that patients deemed to be at high risk for OSA had longer lengths of stay and more complications than those deemed to be at low risk. They randomized 85 patients deemed at high risk for OSA to standard postoperative care or standard care plus APAP but found no significant difference in LOS or complications between the two groups. Admittedly, the number of patients studied was small and further research is needed. But it leaves one more gap of evidence-based recommendations.

Many of the recommendations are to minimize the use of opioids. These would include using regional analgesic techniques or use of NSAID’s where possible. Most also recommend avoiding continuous background opioid infusions in patients on PCA pumps.

The guidelines recommend continuous oxygen supplementation until the patient has been shown to maintain adequate baseline oxygen saturation on room air. When to stop oxygem supplementation is less clear. We’ve cautioned on numerous occasions the possibility that oxygen supplementation in patients receiving systemic opioids may actually mask impending respiratory failure.

So, once again, we recommend you consider setting up a screening program for likely OSA prior to scheduled surgery. The STOP-Bang questionnaire is easy to administer in a few minutes and could be done at the time of surgical booking or other time the surgical team contacts the patient. Having a clinical guideline for dealing with those who score high on the STOP-Bang would be wise, keeping in mind that most of those recommendations will be consensus-based rather than evidence-based.

Our prior columns on obstructive sleep apnea in the perioperative period:

Patient Safety Tips of the Week:

June 10, 2008              “Monitoring the Postoperative COPD Patient”

August 18, 2009         “Obstructive Sleep Apnea in the Perioperative Period”

August 17, 2010         “Preoperative Consultation – Time to Change”

July 13, 2010               “Postoperative Opioid-Induced Respiratory Depression”

February 22, 2011       “Rethinking Alarms”

November 22, 2011    “Perioperative Management of Sleep Apnea Disappointing”

What’s New in the Patient Safety World columns:

July 2010                     “Obstructive Sleep Apnea in the General Inpatient Population”

November 2010          “More on Preoperative Screening for Obstructive Sleep Apnea”

March 2012                 “Postoperative Complications with Obstructive Sleep Apnea”

References:

Chung F, Subramanyam R,  Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. British Journal of Anaesthesia 2012; 108 (5): 768–75 (2012)

http://bja.oxfordjournals.org/content/108/5/768.full.pdf+html

Chung F, Liao P, Elsaid H, et al. Oxygen Desaturation Index from Nocturnal Oximetry: A Sensitive and Specific Tool to Detect Sleep-Disordered Breathing in Surgical Patients. Anesthesia & Analgesia 2012; 114(5): 993-1000 Published online before print February 24, 2012

http://www.anesthesia-analgesia.org/content/114/5/993

Venkateshiah SB, Collop NA. Sleep and Sleep Disorders in the Hospital. CHEST 2012; 141(5): 1337-1345

http://chestjournal.chestpubs.org/content/141/5/1337.abstract

American Society of Anesthesiologists. Practice Guidelines for the Perioperative Management of Patients with Obstructive Sleep Apnea. A Report by the American Society of Anesthesiologists Task Force on Perioperative Management of Patients with Obstructive Sleep Apnea. Anesthesiology 2006; 104: 1081–93

http://journals.lww.com/anesthesiology/Fulltext/2006/05000/Practice_Guidelines_for_the_Perioperative.26.aspx

Chung SA, Yuan H, Chung F. A Systemic Review of Obstructive Sleep Apnea and Its Implications for Anesthesiologists. Anesthesia & Analgesia 2008; 107(5): 1543-1563

http://www.anesthesia-analgesia.org/content/107/5/1543.short

Adesanya AO, Lee W, Greilich NB, Joshi GP. Perioperative Management of Obstructive Sleep Apnea. Chest December 2010; 138(6): 1489-1498

http://chestjournal.chestpubs.org/content/138/6/1489.abstract

Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11 February 2011)

http://www.pssjournal.com/content/pdf/1754-9493-5-3.pdf

O'Gorman S, Horlocker T, Huddleston J, et al. Does Self-Titrating CPAP Therapy Improve Postoperative Outcome in Patients at Risk for Obstructive Sleep Apnea Syndrome? A Randomized Controlled Clinical Trial. Chest 2011; 140: 4 Meeting Abstracts 1071A; doi:10.1378/chest.1119434

http://chestjournal.chestpubs.org/cgi/content/meeting_abstract/140/4_MeetingAbstracts/1071A?sid=e35e54ff-eb15-4866-98e9-66e6df8a7583

also reported in: Harrison L. Postop APAP Fails in High-Risk Sleep Apnea Patients. Medscape Medical News. November 3, 2011

http://www.medscape.com/viewarticle/752859

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What's New in the Patient Safety World?

May 2012

·O2 in STEMI

·Drug Shortages Taking a Toll

·Safety of Hypnotic Drugs

·Post-op Activation of Emergency Response Teams

·Foley Catheter Hazards

·Another Fentanyl Patch Warning from FDA

O2 in STEMI

Over the past several years there have been an increasing number of studies challenging the time-honored practice of administering oxygen to patients with acute MI regardless of their oxygenation status (see our Patient Safety Tips of the Week April 8, 2008 “Oxygen as a Medication” and January 27, 2009 “Oxygen Therapy: Everything You Wanted to Know and More!” and our What’s New in the Patient Safety World columns for July 2010 “Cochrane Review: Oxygen in MI” and February 2012 “More Evidence of Harm from Oxygen”).

A new pilot randomized controlled trial (Ranchord 2012) found no evidence of benefit or harm from oxygen administration in patients with acute ST-elevation myocardial infarction (STEMI). However, patients were not randomized until they reached the hospital so some had already received oxygen in transit to the hospital. The study results also had wide confidence intervals. So further studies are still needed.

Hopefully answers may be forthcoming in the near future. The AVOID Trial (Stub 2012) is an Australian randomized controlled trial of oxygen therapy beginning in the prehospital phase in patients with acute STEMI who are not hypoxemic. The article details the clinical trial that is about to begin and also notes two other ongoing trials that may provide answers.

In the interim, think twice before you begin oxygen on the non-hypoxemic patient.

References:

Ranchord AM, Argyle R, Beynon R, Perrin K, et al. High-concentration versus titrated oxygen therapy in ST-elevation myocardial infarction: A pilot randomized controlled trial. Am Heart J 2012; 163(2): 168-175

http://www.ahjonline.com/article/S0002-8703%2811%2900773-3/abstract

Stub D, Smith K, Bernard S, et al. A randomized controlled trial of oxygen therapy in acute myocardial infarction Air Verses Oxygen In myocarDial infarction study (AVOID Study).  Am Heart J 2012; 163: 339-345

http://download.journals.elsevierhealth.com/pdfs/journals/0002-8703/PIIS0002870311008271.pdf

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Drug Shortages Taking a Toll

At our Patient Safety Committee or Medication Safety Committee or P&T Committee meetings we used to spend a fair amount of time discussing drugs recalled. Now we spend a much greater amount of time discussing drug shortages. The number of drug shortages has escalated dramatically over the past 5 years. Not only are the drug shortages causing problems in healthcare facility operations and budgets, but they are also now clearly impacting on patient safety.

Anesthesiology, an area especially hit hard by drug shortages, recently responded to a survey put out by the American Society of Anesthesiologists (ASA). Almost 98% of the respondents said they had been impacted by the shortage of at least one drug (Clark 2012, ASA 2012). This has resulted in use of less than preferred drugs, altered procedures, delays, canceled cases and, regrettably, some deaths. In addition, use of the alternative drugs has tended to lengthen postoperative stays and increase costs of care.

ISMP (Institute for Safe Medication Practices) did its own survey recently and identified frequent occurrences of patient harm as a result of drug shortages (ISMP 2012).

Lack of treatment or delayed treatment are the most well-known consequences of the drug shortage problem. In fact, it was largely the shortages of cancer chemotherapeutic agents that initially raised this issue to the public level. But there are many other consequences as well.

Problems with use of alternative medications or alternative preparations were the biggest issues identified in the ISMP survery. The alternative drug may simply be less adequate than the preferred drug (35% of the cases with harm in the ISMP survey). But errors made in the dose or form of the alternative medication are also problematic (27% of the cases with harm in the ISMP survey). Providers may be less knowledgeable about the use of those alternatives. The recent shortage of morphine in Canada (ISMP Canada 2012b) has probably led to more use of HYDROmorphone (Dilaudid) and we’ve previously discussed the fact that many physicians do not understand that Dilaudid is much more potent than morphine on a mg basis (see our September 21, 2010 Patient Safety Tip of the Week “Dilaudid Dangers”). Similarly, in facilities accustomed to using IV lorazepam in status epilepticus, a shortage of IV lorazepam might lead to use of IV diazepam and providers may be less familiar with dosing, half-lifes, etc.

Alternative preparations may be problematic in other ways. In the recent ISMP newsletter a shortage of the multivitamin prep used with parenteral nutrition led to use of a different multivitamin in an oral form. The patient developed Wernicke’s encephalopathy and only then was it recognized that the alternative prep did not contain thiamine.

Shortages of local anesthetics have given rise to providers using unusual concentrations of those agents (or the concentrations of other agents mixed in with the anesthetic such as epinephrine), thereby increasing the likelihood of misuse in some circumstances.

The ISMP survey provides numerous specific examples of adverse effects caused by switching to alternative agents.

Both ISMP (ISMP 2012, ISMP 2010) and ISMP Canada (ISMP Canada 2012a) have provided useful guidance for facilities in dealing with and preparing for such drug shortages. The American Society of Hospital-System Pharmacists (Fox 2009) and a previous ISMP newsletter (ISMP 2010) made a number of recommendations on planning and contingencies for drug shortages.

First and foremost, you need to be aware of potential impending shortages. As before, such discussions should be a priority at your regular meetings of your P&T Committee (or your Patient Safety or Medication Safety Committees if applicable). Use your collaborative networks, formal or informal, to learn about impending shortages and potential solutions. Hopefully your group purchasing organization is out there doing some of this for you but use your hospital associations, your specialty societies, the Internet and social media networks as well.

While you may be unable to plan in advance for drug shortages of a specific drug, you can put in place the infrastructure and contingency plan to deal with shortages as they arise. One solid recommendation is doing a failure mode and effects analysis (FMEA) on drug shortages. This is a good way to get a handle on how you would develop and implement contingency plans in the event of a significant drug shortage. The 2010 ISMP newsletter (ISMP 2010) contains a sample FMEA from OhioHealth Pharmacy Systems that can serve as a good starting point for your own FMEA.

ASHP (Fox 2009) recommends an approach to planning for drug shortages in three phases: identification and assessment, preparation, contingency. In the assessment phase you would do things like identify the potential shortage, assess your current inventories, determine what potential outside sources and supplies might be available, and estimate the expected duration of the shortage if possible. You also would assess your supplies of any likely alternative agents. Remember also that a shortage of one drug may also lead to a shortage of the alternative drugs as well. A good “threat analysis” here would take into account patient care, patient safety, and cost issues as well.

The preparation stage is where you identify who will be impacted by the expected shortage (both patients and staff), what alternatives are available, how you will prioritize use of that drug and the alternatives, and how you will educate staff (and patients, if necessary) about options.

Prioritization can be complicated. Take parenteral lorazepam, one of the drugs for which there has been a recent shortage, as an example. You would first go through your pharmacy and purchasing/billing information to determine where and for what conditions this drug has been used historically. You might identify areas of use as the ICU’s, OR, procedure room, ER, behavioral health, and med/surg nursing units. You need to do a similar analysis for any agents you might be considering as alternatives. In your analysis you might note that ER use is infrequent but you might also identify that having it available for treatment of status epilepticus is a priority. So you might end up with a prioritization that says you’d like to restrict use to the ER and ICU, especially if the alternative agents are more readily usable in the other locations.

The ISMP Canada bulletin (ISMP Canada 2012a) also recommends you have plans in place to minimize wastage of the drug in potential shortage. However, they are careful to note this must be done in a safe manner. They have particularly good recommendations about precautions that must be taken any time that a product is divided up into multiple doses.

During this phase you should also be firming up your relationships with collaborative partners. For example, planning with neighboring hospitals about the ability to borrow medication for emergency cases (or transfer patients to a facility that has the necessary agent).

ASHP also cautions against hoarding, stockpiling, and speculative purchasing because these practices may inadvertently exacerbate the shortages.

The education and communication components of the preparation phase are crucial. You should have a formal process by which therapeutic alternatives are identified. This should include not only pharmacists but also nurses and physicians (and other providers as necessary). You might do this through your formal medical staff committee structure. However, given the typical delays in wending through the medical staff bureaucratic and committee layers, a better plan might include delegation by the medical staff to an ad hoc group having appropriate medical staff representation. You will have to educate physicians and nursing staff about the alternative agents (different doses, half-lifes, side effect profiles, monitoring parameters, look-alike/sound-alike issues, product segregation, alerts, warnings, independent double checks, etc.). You may also have to make changes to your pharmacy IT systems, EMR/CPOE, order sets, standing protocols, clinical decision support systems, barcoding, automated dispensing machines, and maybe even your smart pump drug libraries. You have to figure out what are the best ways to communicate to your various staff and how often. Communication in this setting is not a one-time deal. It must be sustained.

The contingency phase includes decisions about whether drug products might be purchased from “gray market” sources or from compounding pharmacies, knowing that there may be risks to both these sources. These decisions should be based on a philosophy adopted by the organization well before the pressures and emotions generated by the acute shortage occur. Budgetary concerns must also be addressed and additional funds may need to be requested not only for higher drug costs but for additional staffing and overtime needs for all the other things involved in dealing with these issues. And Risk Management should be involved, particularly if you will be prioritizing which patients will get the drug in shortage and which will not. You should also have a strong communication plan, not only for your providers and staff but also for the patients likely to be affected by the shortage.

After implementation it is critical that you monitor carefully for both adverse consequences of the shortage and adverse consequences of the alternative therapies implemented. And, once the shortage has been resolved, close the loop and go back and garner all the lessons learned in dealing with that particular shortage. You’ll need to know what worked and what didn’t because you’ll need to know these when, not if, the next drug shortage arises.

Reasons for the shortages are myriad. A GAO report (GAO 2011) noted that the cause of shortages of 12 of 15 drug shortages were primarily due to manufacturing problems. The 2009 ASHP report (Fox 2009) provides a good compilation of the multiple factors contributing to drug shortages. But it is not only manufacturing problems that have led to shortages. Problems that make marketing of some generic drugs non-competitive and especially problems with our current reimbursement system (Gatesman 2011) are also root causes. Whatever the root causes, this problem has clearly escalated to the point that it is now a significant patient safety hazard. With pressure coming from state and national healthcare associations, medical societies, ISMP, ASHP (American Society of Health-System Pharmacists) patient advocacy groups and others, Congress is looking at a number of potential bills aimed at alleviating the problems of drug shortages.

In the interim, you have to be ready to deal with drug shortages. Make awareness of drug shortages a priority for your system and make sure that you have contingency plans to deal with them even before they occur.

References:

Clark C. Nearly All Anesthesiologists Report Drug Shortages. HealthLeaders Media 2012; April 19, 2012

http://www.healthleadersmedia.com/content/PHY-279127/Drug-Shortages-Taking-Tremendous-Toll

ASA (American Society of Anesthesiologists). Drug Shortage Survey. 2012

http://www.asahq.org/For-Members/Advocacy/Federal-Legislative-and-Regulatory-Activities/Drug-Shortages.aspx#Drug%20Shortages%20Survey

ISMP (Institute for Safe Medication Practices). A shortage of everything except errors: Harm associated with drug shortages. ISMP Medication Safety Alert. Acute Care Edition 2012; April 19, 2012

http://www.ismp.org/Newsletters/acutecare/showarticle.asp?id=20

ISMP Canada. Drug Shortages and Medication Safety Concerns. ISMP Canada Safety Bulletin 2012; 12(3): 1-4 March 20, 2012

http://www.ismp-canada.org/download/safetyBulletins/2012/ISMPCSB2012-03_Drug_Shortages.pdf

ISMP Canada. Recall of Morphine 2 mg/mL (1 mL Ampoules) and Medication Safety Strategies in a Drug Shortage Situation. ISMP Canada Safety Bulletin 2012; 12(4): 1-2 March 26, 2012

http://www.ismp-canada.org/download/safetyBulletins/2012/ISMPCSB2012-04_MorphineRecall_and_MedSafetyStrategies.pdf

ISMP (Institute for Safe Medication Practices). Weathering the storm: Managing the drug shortage crisis. ISMP Medication Safety Alert. Acute Care Edition 2010; October 7, 2010

http://www.ismp.org/Newsletters/acutecare/articles/20101007.asp

Fox RE, Birt A, Janes KB, Kokko H, et al. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009; 66: 1399-1406.

www.ashp.org/DocLibrary/BestPractices/ProcureGdlShortages.aspx

US Government Accountability Office (GAO). Drug Shortages. FDA's Ability to Respond Should Be Strengthened. GAO-12-315T, Dec 15, 2011

http://www.gao.gov/products/GAO-12-315T

Gatesman ML, Smith TJ. The Shortage of Essential Chemotherapy Drugs in the United States. N Engl J Med 2011; 365: 1653-1655

http://www.nejm.org/doi/full/10.1056/nejmp1109772

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Safety of Hypnotic Drugs

Those who work in hospital or long-term care settings are familiar with 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”).

But for the most part we have been paying attention to the adverse effects in a very narrow timeframe. And, other than hearing anecdotal stories about someone doing bizarre things at night and having no recall while on sleep meds, we haven’t paid as much attention to the long-term adverse effects of such drugs. But that seems to be changing.

A series of papers using data from a large integrated health system has documented an association between hypnotic drugs and mortality. The first paper (Kripke 2012) compared mortality rates in patients prescribed any hypnotics compared to a matched cohort that was not prescribed such drugs. Even after adjustment for potential confounding factors they found the risk for death was about 4.5 times higher in those who had been prescribed hypnotics. This applied to all hypnotics, including new agents that have long been felt to be “safer” than the older hypnotics. It also applied to all age groups and the hazard ratio was highest in the 18-55 year old age group. They did find a dose-response relationship where the risk increased with increasing numbers of sleep pills taken. However, even for the group taking 1-18 doses per year the hazard ratio for death was 3.60. For those taking over 132 doses per year, the hazard ratio was 5.32.  Patients in the latter category also had an association with an increased incidence of new cancer. The causes of death were not known but the authors speculate about multiple potential mechanisms by which hypnotic drugs might increase the risk of death.

A second paper by the same group and same database, presented in abstract form at the American Heart Association annual scientific sessions, found that the risk of death was even higher in the subset of patients having obesity (Langer 2012). Those in the highest tertile of sleep med use had a risk of death 9.3 times higher than those not taking sleep meds. Even those taking only 1-18 doses a year had a risk of death 8 times higher than similar patients not prescribed any sleep meds. And in this group men were about twice as likely as women to die. 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. Nevertheless, the association is significant and 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.

Be especially wary of using these drugs even temporarily in the hospital. It is amazing how often drugs begun in the hospital end up being continued indefinitely after the patient is discharged (see our March 2011 What’s New in the Patient Safety World column “Inappropriate Medications Often Start in the ICU”).

In our August 2009 What’s New in the Patient Safety World column “Bold Experiment: Hospitals Saying No to Sleep Meds” we noted Doylestown Hospital had already implemented a significant noise reduction program and were trying to make the inpatient environment conducive to sleep by lowering the lights, closing doors, allowing masks or earplugs, using more private rooms, and allowing personal stereos to be used. Hospital noise levels are unacceptably high and can lead to significant sleep loss for patients (Yoder 2012).

But the new studies suggesting a link between sedative/hypnotic drugs and mortality tell us 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

Yoder JC, Staisiunas PG, Meltzer DO, et al. Noise and Sleep Among Adult Medical Inpatients: Far From a Quiet Night. Arch Intern Med 2012; 172: 68 - 70

http://archinte.ama-assn.org/cgi/content/extract/172/1/68?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=yoder&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

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Post-op Activation of Emergency Response Teams

A recent Mayo Clinic study (Weingarten 2012) identified risk factors for activation of emergency response teams (ERT) for patients discharged from PACU’s (post-op anesthesia care units) to regular nursing units. The overall rate of such ERT activation in the first 48 hours was 2 in 1000 cases and 62% of these occurred within the first 12 hours. They found that 3 factors predicted such ERT activation: (1) preoperative central nervous system comorbidity (2) preoperative opioid use and (3) intraoperative use of phenylephrine infusion or increased intraoperative fluid administration (used as proxies for intraoperative hemodynamic instability). Hypotension, changes in mental status, and respiratory problems were the leading reasons for ERT activation. Patients needing ERT activation had longer lengths of stay and more severe in-hospital complications, including higher 30-day mortality rates. They suggest that patients with these risk factors might be considered for discharge to higher levels of care (ICU’s or step-down units).

Of the 30% of ERT patients who used opioids, 13% received naloxone as an ERT intervention. They have a good discussion about other studies showing patients receiving opioids (via PCA or other routes) have higher rates of ERT activation for respiratory depression and that opioid-tolerant patients are particularly problematic.

Note that most of their patients discharged from the PACU to the floor were on supplemental oxygen (61% for their ERT patients and 50% for their controls). We’ve discussed on numerous occasions that supplemental oxygen therapy may mask respiratory depression and delay its recognition if there is only pulse oximetry monitoring and no concomitant capnographic monitoring. Note that it is an extremely common anesthesia practice to use supplemental oxygen post-op. We strongly recommend that before beginning PCA or other IV opioids the patient should be carefully assessed for legitimate indication for supplemental oxygen. If that need is indeed present special monitoring for respiratory depression should be added (monitoring CO2 and monitoring for respiratory rate and apnea).

By the way, the article also has a good discussion on published outcomes of ERT’s on surgical patients vs. medical patients. Long-standing debates over the success (or lack thereof) of ERT’s (also known as rapid response teams or RRT’s) usually focus on whole hospital populations. This article notes that studies of ERT’s in surgical populations tend to have more favorable outcomes and that there may be more reversible causes of deterioration in the surgical population that are amenable to ERT interventions.

References:

Weingarten TN, Venus SJ, Whalen FX, et al. Postoperative Emergency Response Team Activation at a Large Tertiary Medical Center. Mayo Clinic Proc 2012; 87(1): 41-49, January 2012

http://www.mayoclinicproceedings.org/article/S0025-6196%2811%2900005-X/fulltext

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Foley Catheter Hazards

We’ve done a host of columns on prevention of CAUTI’s and have always focused foremost on avoiding Foley catheters in the first place. In the last few months there have been several good articles focusing on eliminating unnecessary use of indwelling catheters.

While most studies have focused on catheter-association urinary tract infections (CAUTI’s) as the most undesirable outcome of catheterization, there are other untoward effects as well. We’ve previously mentioned other adverse effects, including GU trauma, reduced mobility (the “one-point restraint”), falls, and delirium. Recently a study (Leuck 2012) found that catheter-related GU trauma was as common as symptomatic UTI and also that catheterization led to frequent antibiotic treatment for asymptomatic bacteruria despite guidelines to the contrary.

The Michigan Keystone Project (Fakih 2012), a state-wide effort to reduce inappropriate urinary catheter use in Michigan, resulted in a 28% reduction in catheter use (from 18.1% at baseline to 13.8% after two years). In addition, the rates for appropriate catheter indications increased from 44.3% to 57.6%. Improvement began as soon as two weeks after initiation of the intervention(s) and continued to progress for two years. The intervention included buy-in from leadership, formation of improvement teams (with a nursing and physician champion, infection preventionist, and other stakeholders), dissemination of information about appropriate indications for catheters, various webinars, daily catheter rounds, proper insertion and maintenance techniques, data collection and feedback. However, the authors and the accompanying editorial (Mourad 2012) point out that there was substantial variability across the participating hospitals and some hospitals did not provide benchmarking data for the entire period. This highlights the need for continuing involvement of key stakeholders and champions.

Another recent article (Shimoni 2012) demonstrated that use of guidelines restricting catheter use to certain indications combined with daily chart rounds was successful in an Israeli hospital at reducing the overall rate of catheterization from 17.5% to 6.6%. The biggest reduction in catheter use was in 3 categories: (1) incontinent patients unable to provide a urine sample for culture (2) patients with CHF and (3) patients hospitalized for palliative care.

A comprehensive review (Bernard 2012) of various strategies to reduce the duration of indwelling catheter use and CAUTI’s was also just published. This summarizes the literature and highlights the successes of both nurse-led interventions and informatics-led interventions (alerts, stop orders, etc.) to reduce inappropriate catheter use and CAUTI’s.

In our prior columns we have stressed that in addition to strong leadership and buy-in from key stakeholders, the system you put in place should have both a pre-emptive component and a surveillance component. The pre-emptive component can be either low-tech or hi-tech. The simple colored sticker alert shown in our January 8, 2008 Patient Safety Tip of the Week “Urinary Catheter-Associated Infections” has given way to computerized physician order entry (CPOE) order entry screens that request indication and expected duration any time someone orders a Foley catheter. Adding lines for indication and duration to standardized order sets or pre-printed order sheets can also be effective. Alternatives to Foley catheters may include condom catheters in males or intermittent catheterization and use of portable bladder scanners may reduce the need for any kind of catheter in the first place.

The second component of your system is the surveillance component. That means assessing all patients with urinary catheters to see if they still need them. We routinely look for unnecessary catheters during patient safety “walk rounds” and so should you. However, you need a system in place so they are looked for on a daily basis. Make this activity a “checklist” item on nursing rounds or teaching rounds. Also, if your hospital uses a barcode system to track inventory, adapt that system to alert you to every patient to whom a catheter was attached. Educating your patients to question why they need or still need a catheter should be part of your patient-oriented patient safety program.

And, of course, good nursing care for those catheters that are indicated is also crucial.

Be sure to include monitoring and measuring in your QI activities because the initial Hawthorne effect of implementing such a system often fades with time. Posters and screensavers about preventing CAUTI’s may generate some enthusiasm for your program early on but you need more to ensure durability of your program long-term. Feedback and celebrating success are important in that regard.

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

• May 8, 2007 Tip of the Week “Doctor, when do I get this red rubber hose removed?”
• January 8, 2008 Tip of the Week “Urinary Catheter-Associated Infections”
• April 2008 What’s New in the Patient Safety World column “More on Nosocomial UTI’s”
• June 24, 2008 Tip of the Week “Urinary Catheter-Related UTI’s: Bladder Bundles”
• April 21, 2009 Tip of the Week “Still Futzing with Foleys?”
• June 9, 2009 Tip of the Week “CDC Update to the Guideline for Prevention of CAUTI”
• March 2010 “IDSA CAUTI Guidelines”
• February 2011 What’s New in the Patient Safety World column “Catheters Not Needed in C-Sections?”
• January 2012 “CAUTI’s Still Get No Respect”
• May 2012 “Foley Catheter Hazards”

References:

Leuck A-M, Wright D, Ellingson L, Kraeme L, et al. Complications of Foley Catheters—Is Infection the Greatest Risk? Jour Urol 2012; 187: 1662-1666

http://www.jurology.com/article/S0022-5347%2811%2906062-9/abstract

Fakih MG, Watson SR, Greene MT, et al. Reducing Inappropriate Urinary Catheter Use: A Statewide Effort. Arch Intern Med 2012; 172(3): 255-260

http://archinte.ama-assn.org/cgi/content/abstract/172/3/255

Mourad M, Auerbach A. Improving Use of the "Other" Catheter: Comment on "Reducing Inappropriate Urinary Catheter Use". Arch Intern Med 2012; 172(3): 260-261

http://archinte.ama-assn.org/cgi/content/extract/172/3/260

Shimoni Z, Rodrig J, Kamma N, Froom P. Will more restrictive indications decrease rates of urinary catheterisation? An historical comparative study. BMJ Open 2012; 2: 2 e000473 doi:10.1136/bmjopen-2011-000473

http://bmjopen.bmj.com/content/2/2/e000473.full.pdf+html?sid=605d25af-aebb-4885-8263-deef86e875b9

Bernard MS, Hunter KF, Moore KN. A Review of Strategies to Decrease the Duration of Indwelling Urethral Catheters and Potentially Reduce the Incidence of Catheter-associated Urinary Tract Infections. Urol Nurs 2012; 32(1): 29-37

http://www.medscape.com/viewarticle/759922

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Another Fentanyl Patch Warning from FDA

In our June 28, 2011 Patient Safety Tip of the Week “Long-Acting and Extended-Release Opioid Dangers” we discussed potential dangers of a number of long-acting opiates, including fentanyl patches. Then in our September 13, 2011 Patient Safety Tip of the Week “Do You Use Fentanyl Transdermal Patches Safely?” we provided numerous recommendations to improve the safety of fentanyl patches. We stressed the importance of appropriate disposal of such patches because of potential dangers to children and pets. We highlighted the dangers pointed out by Michael Cohen and ISMP that children may mistake such transdermal patches for Band-Aids, tattoos or stickers and may put them on their skin with devastating, even fatal, outcomes (Cohen 2011).

Now the FDA has issued another warning about fentanyl patch dangers (FDA 2012). This one particularly highlights the risk to small children. They noted 26 cases of pediatric accidental exposures to fentanyl patches reported over the past 15 years, ten of which resulted in death and 12 in hospitalization. Sixteen of the 26 cases occurred in children two years old or younger. They note that the mobility and curiosity of such young children provide opportunities for them to find lost patches, take improperly discarded patches from the trash, or find improperly stored patches, all of which may result in patches being placed in their mouths or sticking to their skin.

Another possibility we had not previously considered was exposure when a child is being held by someone wearing a partially detached patch which can then transfer to the child.

FDA actually recommends that for appropriate disposal the adhesive side of the patch should be folded together and then the patch should be flushed down the toilet. They also published a list in 2011 of all the medications that should be disposed of by flushing down the toilet (FDA 2011) to avoid accidental exposure for people or pets.

Whether you are a healthcare facility or a physician practice, you need to be very wary about the dangers of fentanyl patches, not only to your patients but to their families, neighbors and pets and perhaps even to your own staff. The two prior Patient Safety Tips of the Week we mentioned above have many useful tips.

Reference:

Cohen M. Warning! Kids may mistake drug patches as Band-Aids, tattoos or stickers. Philly.com January 3, 2011

http://www.philly.com/philly/blogs/healthcare/Warning_Kids_may_mistake_drug_patches_as_Band-Aids_tattoos_or_stickers_.html

FDA. FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (“Patches”). April 18, 2012

http://www.fda.gov/Drugs/DrugSafety/ucm300747.htm

FDA. Disposal of Unused Medicines: What You Should Know. List of Medicines Recommended for Disposal by Flushing. 2011

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#MEDICINES

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