What’s New in the Patient Safety World

June 2010

·        The July Effect: Myth or Reality?

·        Critical Care Medicine Supplement on Adverse Events in the ICU

·        Seeing Clearly a Common Sense Intervention

·        WHO Checklist for Radiological Interventions

·        The Frailty Index and Surgical Outcomes




The July Effect: Myth or Reality?


For years many have warned that the most dangerous time to be admitted to hospitals in the US was in July when new housestaff come on board. However, numerous studies in the past have been unable to corroborate that with good evidence. Now a new study published online first in the Journal of General Internal Medicine (Phillips and Barker 2010) provides some evidence to support the reality of the “July effect”. Using data from computerized death certificates from 1979 to 2006, they demonstrated that there was a consistent spike in deaths inside medical institutions coded as being due to fatal medication errors but only within counties having teaching hospitals. Moreover, the July spike was greater in those counties having a greater concentration of teaching hospitals. They found no similar spike for deaths of all causes or for deaths due to adverse medication effects (i.e. those medication-related deaths felt not to be preventable). Though the authors did consider potential alternative explanations (eg. more vacations in July, summer spikes in alcohol use and trauma, etc.) they conclude the most likely explanation for the “July effect” is the influx of new housestaff in teaching institutions. They also did not find evidence of a change in the July spike as new residency work hour rules came into effect.


Though this evidence is indirect and provides us only with an association, not a clearcut causal effect, the data are pretty striking. The authors discuss potential implications such as the need for better defining the responsibilities assigned to new housestaff, increasing supervision, and increasing education about medication safety.


We’d like to see if CPOE (computerized physician order entry) with clinical decision support systems (CDSS) has had any impact on the “July effect”. There is at least some anecdotal evidence that more junior physicians may be more amendable to following the recommendations in various alerts generated by CDSS. Most of the data in the study actually ended in 2004, a time at which a paucity of teaching institutions were using CPOE with good CDSS. So it would be interesting for them to extend their study and see whether the July spike has diminished at all over the last 5 years when the use of CPOE with CDSS has increased substantially.


Keep in mind also that lots of other things happen in hospitals in July. Not only is there an influx of new residents and interns, but housestaff who just completed their internships now take on supervising roles. You may also have new attendings starting in July and you often have new staff in other healthcare fields (nursing, pharmacy, etc.).


Our December 8, 2009 Patient Safety Tip of the Week “Prescribing Errors” mentioned the EQUIP study done in the UK that provided some interesting insights into prescribing errors. Though originally established to look at prescribing errors made by first year residents, the study demonstrated that prescribing errors were both common and made by physicians at all levels. Looking at over 100,000 medication orders across 20 hospital sites, they found an average error rate of 8.9 errors per 100 medication orders. The error rate for first year residents, responsible for about half the orders, was 8.4% - actually lower than that for the entire group. All physician levels, including attendings, made prescribing errors. The highest rate (10.3%) was actually seen for second year residents. Interestingly, nurses and pharmacists who were allowed to order medications, had much lower error rates. That UK study had some good insights and recommendations for improving the medication prescribing process.


So while cause of the “July effect” may not yet be clearly attributable to new housestaff, it is clearly there and needs to be further investigated.






Phillips DP, Barker  GEC. A July Spike in Fatal Medication Errors: A Possible Effect of New Medical Residents. J Gen Intern Med 2010; published online first June 2010




Dornan T, Ashcroft D, Heathfield H et al. An in depth investigation into causes of prescribing errors by foundation trainees in relation to their medical education. EQUIP study. December 2009





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Critical Care Medicine Supplement on Adverse Events in the ICU



This month’s supplement to the journal Critical Care Medicine is a theme issue about adverse events in the intensive care envrironment and has some really excellent patient safety articles.


One paper (Stockwell 2010) describes the various systems and sources of information that can be used for surveillance for adverse events in the ICU setting. These include not only the more historical methods that facilitate trending data over time but also some of the more real-time tools (like trigger tools) that may help lead to immediate interventions that may prevent such adverse events. They stress good systems utilize multiple methods for surveillance and detection. They also stress that you need a system of “just culture” in the ICU to facilitate your quality improvement efforts.


An excellent paper (Kane-Gill et al 2010) describes the risk factors for adverse drug events in the ICU. ICU patients are particularly vulnerable to adverse drug events because of the complexity of the ICU environment, multiple distractions, high risk of the individual patients, rapid changes in pharmacotherapy, complex drug regimens, frequent use of high alert medications, and the modes of medication administration. They discuss the economic impact of such adverse events, with each one costing $6000 to $9000. And they stress the role of the entire ICU team in the prevention of adverse events.


The paper on human factors in medication and patient safety in the ICU (Scanlon 2010) is excellent and provides a comprehensive review of the research done in human factors engineering and understanding a systems approach to medical care. And the article on nursing implications (George 2010) further describes many of the important human factors involved in the ICU.


There is an outstanding article on the common drug interactions leading to adverse events in the ICU (Papadopoulos 2010). Going well beyond the usual discussion of renal and hepatic influences on drugs in ICU patients, this paper discusses effects of gastric pH and gastric motility, disruption of intestinal flora, changes in protein binding, chelators, various cytochrome systems, disease state interactions, coagulopathies, infection, and drug-laboratory interactions among others.


Not surprisingly, given our previous series of articles on delirium and issues of ICU oversedation, our favorite article in this supplement is the one on adverse events associated with use of analgesics, sedatives and antipsychotics in the ICU (Devlin 2010). This article provides excellent discussions about both oversedation in the ICU and delirium and also discusses some of the more unusual problems encountered with specific drugs, such as muscle rigidity with Fentanyl and propofol-related hypertonicity and seizure-like movements, It has a good description of drugs causing hypotension, hypertension, bradycardia, tachycardia, prolongation of the QTc interval, and arrhythmias. It even has a section on the toxicities of some of the other substances in IV formuations, such as propylene glycol, and a thorough discussion of the propofol-related infusion syndrome. And, importantly, it stresses the complications of withdrawal from a variety of agents used.


And, of course, no theme issue on adverse drug events in the ICU would be complete without a paper on using technology to prevent such events (Hassan 2010). This paper is incredibly thoughtful and presents a very balanced view of both the potential benefits of each technology but also the unintended consequences and the complexities of implementation. Among the technologies discussed are automated dispensing devices, robotics dispensing systems, bar-code medication administration systems, CPOE with clinical decision support, smart pump technology, tele-health technology, and a variety of other useful tools.


And there are good articles on drug-induced arrhythmias and drug-related effects on coagulation, thrombocytopenia, renal, hepatic, endocrine, GI and electrolyte systems, antimicrobial resistance and hyperthermia. There’s even one on genetic predisposition to adverse drug events in the ICU.





Critical Care Medicine. June 2010 - Volume 38 - Supplement, Identification and Prevention of Common Adverse Drug Events in the Intensive Care Unit

pp: S83-S264




Stockwell, David C.; Kane-Gill, Sandra L. Developing a patient safety surveillance system to identify adverse events in the intensive care unit. Critical Care Medicine. 38():S117-S125, June 2010




Kane-Gill, Sandra L.; Jacobi, Judith; Rothschild, Jeffrey M.

Adverse drug events in intensive care units: Risk factors, impact, and the role of team care. Critical Care Medicine. 38():S83-S89, June 2010.




Scanlon, Matthew C.; Karsh, Ben-Tzion. Value of human factors to medication and patient safety in the intensive care unit. Critical Care Medicine. 38():S90-S96, June 2010




George, Elisabeth L.; Henneman, Elizabeth A.; Tasota, Frederick J. Nursing implications for prevention of adverse drug events in the intensive care unit. Critical Care Medicine. 38():S136-S144, June 2010




Papadopoulos, John; Smithburger, Pamela L. Common drug interactions leading to adverse drug events in the intensive care unit: Management and pharmacokinetic considerations. Critical Care Medicine. 38():S126-S135, June 2010




Devlin, John W.; Mallow-Corbett, Stephanie; Riker, Richard R. Adverse drug events associated with the use of analgesics, sedatives, and antipsychotics in the intensive care unit. Critical Care Medicine. 38():S231-S243, June 2010




Hassan, Erkan; Badawi, Omar; Weber, Robert J.; Cohen, Henry. Using technology to prevent adverse drug events in the intensive care unit. Critical Care Medicine. 38():S97-S105, June 2010





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Seeing Clearly a Common Sense Intervention



Sometimes solutions to problems are right in front of our eyes. Pun intended or not, sometimes things that are just common sense fail to be utilized in patient safety. Ever try to walk down or up stairs wearing bifocal lenses? Or walk in any area where surfaces may have bumps or depressions? Even the healthiest of people can trip and fall while wearing bifocals. So think about the elderly who need bifocals and those who are already at risk of falling.


A study just published in the British Medical Journal (Haran et al 2010) looked at the effect of replacing multifocal lenses in patients at risk of falls with single distance vision lenses (and providing appropriate counseling about their use when going outside). This was a randomized controlled trial of community-dwelling elderly patients with presbyopia who used multifocal lenses outdoors at least 3 times a week. The intervention resulted in a 40% reduction in falls in those who regularly took part in outside activities. However, the frequency of falls actually increased in the subgroup that had little outside activity. So the seclection of patients for the intervention must be thoughtful. A couple prior studies that failed to show significant reduction in falls with single vision lenses may have had 2 subgroups “cancel each other out”. In the current study that is actually what happened, too. The overall reduction in falls for all intervention subjects was only 8%, not statistically significant. But the pre-planned subgroup analysis was what demonstrated the beneficial effect in patients who regularly do outside activities.


Actually, some previous studies had shown acute ocular interventions might increase the risk of falls and the editorial accompanying the Haran paper (Campbell et al 2010) stresses that changes should be made step-by-step in the elderly with impaired vision. That editorial also provides some thoughtful insight into problems that may arise when patients wearing transitional (polychromatic) lenses when they come inside from being outside. Since there is a delay in the change in tint of such transitional lenses, vision may become impaired when those patients initially come inside.


So a common sense approach may work. But equally importantly it shows that unintended consequences may pop up.







Haran MJ, Cameron ID, Rebecca Q Ivers RQ, et al. Effect on falls of providing single lens distance vision glasses to multifocal glasses wearers: VISIBLE randomised controlled trial. BMJ 2010;340:c2265, doi: 10.1136/bmj.c2265 (Published 25 May 2010)




Campbell AJ, Sanderson G, Robertson C. Poor vision and falls
BMJ 2010;340:c2456, doi: 10.1136/bmj.c2456 (Published 25 May 2010)






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WHO Checklist for Radiological Interventions


Our regular readers know how we stress the need for use of checklists and for a “timeout” for every procedure, whether at the bedside or in the OR. WHO has come out with a modification of its Surgical Safety Checklist just for radiological procedures. The “WHO Surgical Safety Checklist for Radiological Interventions ONLY”, like its predecessor, has three parts: a sign in, a timeout, and a sign out phase.


The sign in phase includes introduction of all team members and agreement on roles of each. It includes confirmation of the patient identification and the procedure to be performed and the consent for that procedure. It also includes whether site marking has been performed and whether all appropriate imaging studies have been reviewed. It includes a precheck of any anesthesiology equipment and medications to be used and addresses whether pre-procedure antibiotics or VTE prophylaxis are indicated. It asks about factors for bleeding or renal risks. Then it asks whether all equipment needed for the procedure is present and ready to go. Lastly, it encourages discussion of things that could potentially complicate the procedure so all the team can anticipate their roles.


During the timeout phase, the patient’s ASA level and airway risk are assessed, equipment presence and readiness, status of monitoring equipment, anticipated problems, and the surgical site infection bundle components.


The sign out phase included documentation of the name and side of the procedure, status and count of all materials, recording any implanted devices, labeling of any specimens, identification of any equipment issues, and instructions for post-procedural care of othe patient.


This is a useful checklist and could be further modified at your individual sites.






NPSA (UK). WHO Surgical Safety Checklist: for radiological interventions only. April 2010






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The Frailty Index and Surgical Outcomes



Predicting outcomes in elderly patients undergoing surgery has not been an easy task and often the elderly have complications and long lengths of hospital stay after surgery. Many lose their ability to function independently and some form of assisted living after surgery. Being able to accurately predict who will not fare well after surgery would greatly assist in the decision to undergo surgery and to plan for likely contingencies in those who need surgery. Current methods of predicting postoperative complications have had limited success.


Now a new study (Makary et al 2010) has demonstrated that use of the frailty index greatly improves the ability to predict post-surgical outcomes much better than existing methods.


The frailty index uses a score of 0 or 1 for each of five domains: weight loss, weakness, low physical activity, exhaustion, and slow walking speed. It takes about 10 minutes to administer the frailty index. Weakness is measured with a hand ergometer. Walking speed is measured by having the patient walk 15 feet and timing them. Weight loss is 10 or more pounds lost unintentionally in the past year. And the other 2 domains are assessed by asking simple questions. Patients scoring 4-5 are classified as being frail, those scoring 2-3 as intermediately frail. The frailty index has been validated and been predictive of outcomes in medical patients. However, the research group at Johns Hopkins assessed the ability of this index done preoperatively to predict certain post-surgical outcomes.


The frailty index turned out to be very good in its ability to predict surgical outcomes. For instance, the odds ratio for frail patients for postoperative complications after major surgery was 2.54, for length of stay 1.69, and for discharge to a skilled nursing facility or assisted living facility 20.48.  Odds ratios for those with intermediate frailty were somewhat lower but still predictive of all the above. And the frailty index was better than other tools used to predict outcomes (ASA score, Lee’s revised cardiac risk index, and the Eagle score). Adding the frailty index to any of those tools significantly improved the predictability of outcomes.


It will be very interesting to see how the frailty index fares in other settings (eg. community hospitals, etc.). This could be an extremely helpful tool in helping to avoid some of the pain and suffering that occurs with surgery in the elderly and at least serve as a tool to help patients and families anticipate what to expect in patients undergoing surgery.





Makary MA, Segeve DL, Pronovost PJ, et al. Frailty as a Predictor of Surgical Outcomes in Older Patients. Journal of the American College of Surgeons 2010;

DOI: 10.1016/j.jamcollsurg.2010.01.028






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Print “June 2010 What's New in the Patient Safety World (full column)

Print “June 2010 The July Effect: Myth or Reality?

Print “June 2010 Critical Care Medicine Supplement on Adverse Events in the ICU

Print “June 2010 Seeing Clearly a Common Sense Intervention

Print “June 2010 WHO Checklist for Radiological Interventions

Print “June 2010 The Frailty Index and Surgical Outcomes















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