What’s New in the Patient Safety World

May 2017

 

 

·         Another Success for the Safe Surgery Checklist

·         Another Twist in Opioid-Induced Respiratory Depression

·         The Concurrent Surgery Debate Continues

·         FDA Finally Restricts Codeine in Kids; Tramadol, Too

 

 

 

Another Success for the Safe Surgery Checklist

 

 

Among our numerous columns dealing with use of checklists in healthcare and other industries the WHO Surgical Safety Checklist has probably attracted the most attention. Our July 1, 2008 Patient Safety Tip of the Week “WHO’s New Surgical Safety Checklist” described the tool and provided the link to download the checklist tool and instructions how to use it. We also discussed checklist design and use in our September 23, 2008 Patient Safety Tip of the Week “Checklists and Wrong Site Surgery”.

 

In our January 20, 2009 Patient Safety Tip of the Week “The WHO Surgical Safety Checklist Delivers the Outcomes” we discussed the striking improvements in patient outcomes following implementation of the WHO Surgical Safety Checklist at hospitals in eight different countries. Haynes and colleagues (Haynes 2009) demonstrated that mortality at 30-days post-op decreased from 1.5% before introduction of the checklist to 0.8% after. Rate of any complication decreased from 11% to 7%. Both these outcomes were highly statistically significant. That’s a relative risk reduction of approximately 36% for mortality and major morbidity!

 

That striking improvement in outcomes occurred even without complete adherence to all items on the checklist. We discussed the debate as to whether the striking improvement was attributable to use of the checklist per se or to the change in “culture” that accompanied use of the checklist.

 

But in our April 2014 What's New in the Patient Safety World column “Checklists Don’t Always Lead to Improvement” we found that widespread adoption of a surgical checklist in over 100 hospitals in Ontario, Canada failed to demonstrate significant reductions in adjusted rates for mortality or complications (Urbach 2014). The rate of any complication decreased from 3.86% to 3.82% and mortality at 30-days post-op decreased from 0.71% to 0.65% in Canadian study, neither being statistically significant. There was also no significant changes in rates of hospital readmission and emergency department visits within 30 days after discharge. This result was surprising, especially since self-reported compliance with the checklist was over 90% at almost all participating hospitals.

 

Now a new study again demonstrates a striking improvement in mortality rates after implementation of a safe surgery checklist program (Haynes 2017). The South Carolina Hospital Association partnered with Ariadne Labs to establish a state-wide hospital collaborative to facilitate voluntary implementation of the surgical safety program. Hospitals generally followed a comprehensive 12-step implementation program that included active engagement of and buy-in by staff in roll out and adoption of the checklist. Their baseline period was January 2008 through December 2010 and then January 2011 through November 2013 was considered the post-implementation period.

 

Fourteen hospitals completed the program by December 2013. Risk-adjusted 30-day mortality among completers was 3.38% in 2010 and 2.84% in 2013, whereas mortality among other hospitals not participating in the project was 3.50% in 2010 and 3.71% in 2013. That represents a 22% difference between the groups.

 

In an interview in the Charleston, SC Post and Courier (Sausser 2017) Atul Gawande, a co-author of the study and well-known guru on checklists, was quoted “This is a big deal. There isn’t a drug or device that’s been discovered that can reduce mortality in surgery by that magnitude.”

 

In our April 2014 What's New in the Patient Safety World column “Checklists Don’t Always Lead to Improvement” we discussed several possible reasons that the Ontario study failed to show improvement but we also noted multiple other projects that did demonstrate improvement following implementation of checklist programs. Improvements of a magnitude similar to that of the original Haynes study were seen after implementation of the SURPASS checklist (de Vries 2010). That checklist is a very comprehensive checklist that deals with the entire surgical pathway, including pre- and post-operative care as well as events within the OR (see our November 30, 2010 Patient Safety Tip of the Week “SURPASS: The Mother of All Checklists”). After implementation of SURPASS the number of complications per 100 patients dropped from 27.3 to 16.7 and in-hospital mortality dropped from 1.5% to 0.8%. Note that outcomes at several comparable hospitals considered “control” hospitals did not change. And no other significant programs were introduced at the time, further suggesting that the improvements were due to implementation of the checklist. Moreover, complication rates were significantly lower in those patients for whom 80% or more of the checklist items were completed. But the authors are quick to note that the benefits of the checklist implementation are not just due to the checklist but also due to the development of a “culture of safety” that results from such implementation. Also of note was that these improvements occurred at hospitals which already had relatively high levels of quality of care.

 

Another study (van Klei 2012) demonstrated a 15% reduction in adjusted mortality rates after implementation of WHO’s Surgical Safety Checklist and showed outcomes were better in those with full checklist completion compared to those with partial completion or noncompliance.

 

Another group implemented both team training and a comprehensive surgical checklist and demonstrated significant reduction of 30-day morbidity (Bliss 2012). Overall adverse event rates decreased from 23.60% for historical control cases and 15.90% in cases with only team training, to 8.20% in cases with checklist use.

 

A systematic review of the impact of surgical checklists (Treadwell 2014) noted that 10 of 21 studies on implementation of surgical checklists included data on outcomes. Outcomes from those reporting were generally favorable, showing decreases in both inhospital mortality and complication rates.

 

The systematic review by Treadwell et al. (Treadwell 2014) cautions that the association between checklists and improved outcomes does not necessarily imply causation. First, they note that checklists are often implemented as part of a multifaceted strategy to improve care. They also note there may be reporting bias (i.e. perhaps only those with positive outcomes reported outcome data). And, third, it’s possible that not all surgical checklists are beneficial.

 

It’s important to keep in mind that none of these studies was a randomized controlled trial (RCT) and there are several practical barriers to ever doing such an RCT. They all have before/after observational designs and it is conceivable that factors other than just the checklist are important. Indeed, we have always strongly suspected that the change in culture is probably more important than the checklist per se. Developing checklists is not enough. You need to involve your staff in development of those checklists and educate all staff in their importance and implementation. The South Carolina project provides good guidance in how to implement such programs. You also need to audit the use of and adherence to the checklists you develop. The audit should be done for anything you develop a checklist for, not just a safe surgery checklist.

 

Checklists are some of the most valuable tools we have available in quality improvement and patient safety. They are simple and save time in the long run. Most take only minutes to complete. They are also the least expensive of all tools. Though they are simple and can be completed in minutes, the implementation and adoption process is much more complicated. The South Carolina project illustrates that well.

 

 

Some of our prior columns on checklists:

 

 

References:

 

 

WHO Surgical Safety Checklist

http://www.who.int/entity/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf

 

 

Haynes AB, Weiser TG, Berry WR, et al. for the Safe Surgery Saves Lives Study Group. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. N Engl J Med. Online First January 14, 2009 (DOI: 10.1056/NEJMsa0810119), in Print January 29, 2009

http://content.nejm.org/cgi/content/full/NEJMsa0810119

 

 

Urbach DR, Govindarajan A, Saskin R, et al. Introduction of Surgical Safety Checklists in Ontario, Canada. N Engl J Med 2014; 370: 1029-1038

http://www.nejm.org/doi/full/10.1056/NEJMsa1308261

 

 

Haynes AB, Edmondson L, Lipsitz SR, et al. Mortality Trends After a Voluntary Checklist-based Surgical Safety Collaborative. Annals of Surgery 2017; Published Ahead of Print Post Author Corrections: April 6, 2017

http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Mortality_Trends_After_a_Voluntary_Checklist_based.96150.aspx

 

 

Sausser L. New study shows surgery checklists in South Carolina saved patients' lives. Post and Courier (Charleston, SC) 2017; Apr 17, 2017

http://www.postandcourier.com/features/your_health/new-study-shows-surgery-checklists-in-south-carolina-saved-patients/article_26d19324-236c-11e7-ae90-5742fdc34d09.html

 

 

de Vries EN,  Prins HA, Crolla RMPH, et al. for the SURPASS Collaborative Group. Effect of a Comprehensive Surgical Safety System on Patient Outcomes. N Engl J Med 2010; 363: 1928-1937

http://www.nejm.org/doi/pdf/10.1056/NEJMsa0911535

 

 

van Klei WA, Hoff RG van Aarnhem EEH et al. Effects of the Introduction of the WHO “Surgical Safety Checklist” on In-Hospital Mortality: A Cohort Study. Ann Surg 2012; 255: 44-49

http://journals.lww.com/annalsofsurgery/Abstract/2012/01000/Effects_of_the_Introduction_of_the_WHO__Surgical.8.aspx

 

 

Bliss LA, Ross-Richardson CB, Sanzar LJ, et al. Thirty-Day Outcomes Support Implementation of a Surgical Safety Checklist. J Am Coll Surg 2012; 215: 766-776

http://www.journalacs.org/article/S1072-7515%2812%2900965-9/abstract

 

 

Treadwell JR, Lucas S, Tsou ay. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf 2014; 23: 299-31

http://qualitysafety.bmj.com/content/23/4/299.full.pdf+html

 

 

 

 

 

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Another Twist in Opioid-Induced Respiratory Depression

 

 

We’ve done lots of columns focusing on obstructive sleep apnea as a factor contributing to opioid-induced respiratory depression. But there are other factors predisposing to opioid-induced respiratory depression. These include not only chronic pulmonary disorders but also neuromuscular disorders that might be associated with diaphragmatic paralysis and/or pharyngeal paresis (eg. Guillain-Barre syndrome, myasthenia gravis, various muscular dystrophies, etc.).

 

Now a very interesting new contributing factor has been identified: nasal obstructive disorders. A study presented at the PAINWeek 2016 conference found that in an insurance database 11.6% of over 7000 patients who had opioid-induced respiratory depression had codes for nasal obstruction, compared to 6.7% in those who did not experience a serious OIRD event (Weiner 2016). Some of the conditions coded for were deviated nasal septum, nasal polyps, hypertrophy of the turbinates, or other nasal/sinus pathology. In the multivariable analysis, the adjusted odds ratio for patients who experienced serious OIRD having concurrent nasal obstructive pathology was 1.28.

 

In an interview (Kronemyer 2017), the lead author of that study noted that this finding has dual relevance. Not only is it important to identify as a risk factor but it also has therapeutic implications. One of the routes that the rescue drug naloxone is administered is the intranasal route. And those with nasal obstruction may not respond well to intranasal naloxone. The article notes that some patients do not seem to respond well to intranasal naloxone so the lesson is to consider other routes of naloxone administration if a patient is not responding well to intranasal naloxone and has nasal pathology.

 

 

 

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

 

 

 

 

 

References:

 

 

Weiner SG, Joyce A, Thomson H. The Prevalence of Nasal Obstruction as a Consideration in the Treatment of Opioid Overdose (Abstract 128). PAINWeek 2016

http://www.tandfonline.com/doi/full/10.1080/00325481.2016.1224633?src=recsys&

 

 

Kronemyer B. Nasal Obstructions Tied to Serious Opioid-Induced Respiratory Depression. Anesthesiology News 2017; April 14, 2017

http://www.anesthesiologynews.com/Clinical-Anesthesiology/Article/04-17/Nasal-Obstructions-Tied-to-Serious-Opioid-Induced-Respiratory-Depression/40908/ses=ogst?enl=true

 

 

 

 

 

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The Concurrent Surgery Debate Continues

 

 

The Boston Globe’s Spotlight Team, which thrust double-booked or concurrent/ overlapping surgery into the headlines back in 2015 (see our November 10, 2015 Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery”), has again focused attention on this practice. In the new investigation, the Spotlight Team (Saltzman 2017) noted that a urologist routinely performed overlapping surgery in up to 70% of his cases. The Spotlight investigation notes that state regulatory agencies and the ACGME (Accreditation Council for Graduate Medical Education) are reviewing this as well.

 

The Globe report, of course, again raises the issue of informed consent and whether patients understand that their surgeon may not be physically present for portions of their surgery. A recent survey (Kent 2017) looked at knowledge of overlapping surgery, expectations on disclosure during the informed consent process, and their willingness to participate in such a procedure. That survey found that only 3.9% of respondents had any knowledge of the practice of overlapping surgery. Interestingly, though the majority of respondents were not supportive of the practice, 31% supported or strongly supported this practice. But 94.7% believed that the attending surgeon should inform them in advance of overlapping surgery and 95.6% would want definition of the critical components of the operation. And 91.5% felt that the surgeon should document what portion of the operation he or she was present for.

 

We’ve previously noted the paucity of evidence in the literature for or against the practice of double-booked surgery. In our December 13, 2016 Patient Safety Tip of the Week “More on Double-Booked Surgery” we alluded to an unpublished Canadian study that showed increased frequency of complications with overlapping surgery. That study has now been presented in abstract form (Ravi 2017). The researchers defined concurrent hip fracture cases as those that overlapped in time with any other orthopedic case performed by the same attending surgeon. These were matched to hip fractures that were managed non-concurrently on the age and sex of the patient, the type of procedure, the primary surgeon and the hospital. Comparing almost 1000 patients each in concurrent vs. non-concurrent surgery, they found that concurrent patients were at increased risk for surgical complications at 90 days (7% vs. 4.7%) and at one year (8.6% vs. 6%) and that increasing duration of overlap was associated with an increased risk for complication (adjusted OR 1.08 per 10 minutes of overlap).

 

This contrasts with three previous reviews that concluded there was no increase in complications with overlapping surgery. In our November 10, 2015 Patient Safety Tip of the Week “Weighing in on Double-Booked Surgery” we noted Massachusetts General Hospital’s review of its own cases. And in our November 29, 2016 Patient Safety Tip of the Week “Doubling Down on Double-Booked Surgery” we highlighted the study done by Zhang and colleagues at UCSF comparing overlapping cases with non-overlapping cases for a variety of orthopedic surgical procedures performed in an academic ambulatory surgery setting (Zhang 2016). The latter found no difference in patient operating room time, procedure time, and 30-day complication rates between overlapping and non-overlapping surgery. And our December 13, 2016 Patient Safety Tip of the Week “More on Double-Booked Surgery” noted the retrospective review comparing overlapping surgery with non-overlapping surgery at the Mayo Clinic (Hyder 2016). Over 10,000 cases of overlapping surgery were matched to a similar number of non-overlapping surgeries. Adjusted odds ratio for inpatient mortality was greater for non-overlapping procedures (adjusted odds ratio, OR = 2.14 vs overlapping procedures) and length of stay and morbidity were no different.

 

Also, a just released abstract presented at the 2017 American Association of Neurological Surgeons (AANS) Annual Meeting (Bohl 2017, Melville 2017) found better, not worse, outcomes with overlapping surgery. The better outcome measures included hospital length of stay, return to the operating room, and disposition status.

 

Though the Ravi study has only been presented in abstract form and not yet subject to peer review, the findings do raise further concern about overlapping surgery. In our previous columns we noted that the absolute frequency of adverse events related to concurrent surgery is likely relatively small and, hence, such adverse events are likely to be “buried” in large series.

 

As before, we personally would not consent to any form of double-booked surgery and expect our attending surgeon to be present at our procedure even when portions of the surgery are being performed by residents, fellows, or other personnel. We hope that you’ll see our prior columns (listed below) to see our arguments against overlapping surgery and our recommendations for those of you who do allow it. For those of you who plan to allow overlapping surgery at your institution, we refer you to our “Overlapping Surgery Checklist” to help you plan for safe implementation.

 

 

 

See our previous columns on double-booked, concurrent, or overlapping surgery:

 

 

 

References:

 

 

Saltzman J, Abelson J. Star surgeon is scrutinized on concurrent procedures. Boston Globe 2017; March 12, 2017

https://www.bostonglobe.com/metro/2017/03/12/star-surgeon-scrutinized-concurrent-procedures/YgyMjLLbxHjIZIbWCNtOMO/story.html

 

 

Kent M, Whyte R, Fleishman A, et al. Public Perceptions of Overlapping Surgery. Journal of the American College of Surgeons 2017; Published online: February 11, 2017

http://www.journalacs.org/article/S1072-7515(17)30163-1/fulltext

 

 

Ravi B, Pincus D, Wasserstein D, et al. Concurrent Surgery for Hip Fractures is Associated with an Increased Risk for Postoperative Complications. AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting 2017

http://submissions.mirasmart.com/Verify/AAOS2017/submission/temp/radFBEA3.pdf

 

 

Zhang AL, Sing DC, Dang DY, et al. Overlapping Surgery in the Ambulatory Orthopaedic Setting. J Bone Joint Surg Am, 2016; 98 (22): 1859-1867

http://jbjs.org/content/98/22/1859.full

 

 

Hyder JA, Hanson KT, Storlie CB, et al. Safety of Overlapping Surgery at a High-volume Referral Center. Annals of Surgery 2016; Published ahead of print (Post Author Corrections): December 5, 2016

http://journals.lww.com/annalsofsurgery/Abstract/publishahead/Safety_of_Overlapping_Surgery_at_a_High_volume.96310.aspx

 

 

Bohl M. Overlapping Surgeries are not Associated with Worse Patient Outcomes: Retrospective Multivariate Analysis of 14,872 Neurosurgical Cases Performed at a Single Institutiion. American Association of Neurological Surgeons (AANS) 2017 Annual Meeting. Abstract 917. Presented April 26, 2017

http://www.aans.org/flippingbook/QuickPlanner/index.html#100/z

and summarized in:

Melville NA. Outcomes Better, Not Worse, in Overlapping Neurosurgeries. Medscape Medical News 2017; April 28, 2017

http://www.medscape.com/viewarticle/879253

 

 

Our own “Overlapping Surgery Checklist”.

http://www.patientsafetysolutions.com/docs/Overlapping_Surgery_Checklist.htm

 

 

 

 

 

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FDA Finally Restricts Codeine in Kids; Tramadol, Too

 

 

After almost 5 years of warnings about the safety of codeine in children (and more recent warnings about the safety of tramadol) the FDA (FDA 2017) is finally issuing its strongest warning, a Contraindication, alerting that codeine and tramadol should not be used to treat pain in children younger than 12 years, and codeine should not be used to relieve cough in these children. And it added a new Contraindication to the tramadol label to restrict its use in children younger than 18 years to treat pain after a tonsillectomy and/or adenoidectomy.

 

The FDA also issued a new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or compromised respiratory function that may increase the risk of serious breathing problems. And it strengthened the Warning to patients that breastfeeding is not recommended during treatment with codeine or tramadol due to the potential for serious adverse reactions in a breastfed infant, such as excess sedation, respiratory depression, and death.

 

It also cautions healthcare professionals who determine that a codeine-or tramadol-containing product is appropriate for an adolescent patient to counsel parents and caregivers on how to recognize the signs of opioid toxicity, and advise them to stop giving the adolescent codeine or tramadol and seek medical attention immediately if their adolescent is exhibiting these signs.

 

The FDA safety announcement also has a list of prescription codeine and tramadol pain and cough medicines.

 

Our previous 6 columns on the dangers of codeine in children discussed the multiple prior safety alerts from the FDA (FDA 2012, FDA 2013, FDA 2015). These columns described cases of death and serious adverse effects in children treated with codeine following adenotonsillectomy for obstructive sleep apnea. The problem originally noted for codeine was that there are genetic variations that cause some people to be “ultra-rapid metabolizers” of codeine, which leads to higher concentrations of morphine in the blood earlier.

 

In our January 2016 What's New in the Patient Safety World column “FDA Gets Even Tougher on Codeine in Kids” we noted that an advisory committee to the FDA recommended that codeine be contraindicated for pain and cough management in children and adolescents (Firth 2015). They also recommended restricting codeine's over-the-counter availability for this group. Of 29 voting members, 20 voted to contraindicate use of the drug for pain and cough in children younger than 18 years old. Most of the others voted to restrict its use only in younger children. However, the FDA did not take formal action on those recommendations until now.

 

While the initial warnings focused on avoiding codeine in children who were undergoing adenotonsillectomy for obstructive sleep apnea (OSA), the dangers apply more globally to children. Perhaps influencing the FDA was the American Academy of Pediatrics in a statement “Codeine: Time to Say ‘No’ ” (Tobias 2016) that we discussed in our October 2016 What's New in the Patient Safety World column “Another Codeine Warning for Children”. That paper reiterated the evidence of adverse effects of codeine in children and their mechanisms. It noted that codeine is still available in over-the-counter cough formulas in 28 states and the District of Columbia without a prescription. The Tobias paper also discussed the pros and cons of alternatives to codeine in the pediatric population, noting that almost all of them also have some potential downsides.

 

Our May 2014 What's New in the Patient Safety World column “Pediatric Codeine Prescriptions in the ER” noted the continued frequent prescription of codeine-containing products in children despite the previous warnings about adverse reactions. In our November 2015 What's New in the Patient Safety World column “FDA Safety Communication on Tramadol in Children” we noted that education does not seem to have reduced prescription of codeine-containing products. We therefore advocated incorporating “hard stops” (alerts requiring acknowledgement of the warnings about codeine or other opioid in children) into CPOE and e-prescribing systems.

 

We are pleased that the FDA has finally taken this action to restrict the use of codeine and tramadol in the pediatric population.

 

 

 

Some of our previous columns on opioid safety issues in children:

 

 

 

References:

 

 

FDA (US Food & Drug Administration). FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. FDA Safety Announcement 2017; April 20, 2017

https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

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

http://www.fda.gov/Drugs/DrugSafety/ucm313631.htm

 

 

FDA. FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy. Update February 20, 2013

http://www.fda.gov/Drugs/DrugSafety/ucm339112.htm

 

 

FDA (Food and Drug Administration) Briefing Document: The safety of codeine in children 18 years of age and younger. Joint Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Meeting . December 10, 2015

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM475975.pdf

 

 

Firth S. FDA Panel Urges Stronger Regulation of Codeine. An FDA advisory committee voted 28-0 to remove the drug from its OTC monograph for cough and cold. MedPage Today 2015; December 11, 2015

http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/55159

 

 

Tobias JD, Green TP, Cotι CJ, Section on Anesthesiology and Pain Medicine, Committee on Drugs. Codeine: Time to Say “No”. Pediatrics 2016; Originally published online September 19, 2016

http://pediatrics.aappublications.org/content/early/2016/09/15/peds.2016-2396

 

 

 

 

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Print “May 2017 What's New in the Patient Safety World (full column)”

Print “May 2017 Another Success for the Safe Surgery Checklist”

Print “May 2017 Another Twist in Opioid-Induced Respiratory Depression”

Print “May 2017 The Concurrent Surgery Debate Continues”

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