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








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.







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




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






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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 WeekDilaudid 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.







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




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




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




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




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




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




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.




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




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






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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.






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




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




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






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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.





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






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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:









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




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




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




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




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





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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.




Update (June 21, 2012): We and ISMP (ISMP 2012) have received multiple inquiries from hospitals regarding the FDA recommendation to flush used fentanyl patches down the toilet. ISMP recently clarified that the FDA recommendation applies to consumers, not facilities. ISMP believes that in a healthcare setting, if the used fentanyl patch cannot be flushed down the toilet, it may be disposed of in a secure sharps container after folding the patch over on itself. Note that the disposal should be witnessed and documented as per the facility’s narcotic disposal policy. They advise, however, that facilities comply with regulations in individual states.


ISMP. Disposal of fentanyl patches in hospitals. ISMP Medication Safety Alert! Nurse Advise-ERR 2012; 10(6): 1 June 2012










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




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




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





Print “May 2012 Another Fentanyl Patch Warning from FDA






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

Print “May 2012 O2 in STEMI

Print “May 2012 Drug Shortages Taking a Toll

Print “May 2012 Safety of Hypnotic Drugs

Print “May 2012 Post-op Activation of Emergency Response Teams

Print “May 2012 Foley Catheter Hazards

Print “May 2012 Another Fentanyl Patch Warning from FDA













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