What’s New in the Patient Safety World

July 2010

·        More on Probiotics for VAP

·        JCAHO Sentinel Event Alert on Violence in the Healthcare Setting

·        Obstructive Sleep Apnea in the General Inpatient Population

·        Methotrexate Overdose Due to Prescribing Error

·        Cochrane Review: Oxygen in MI





More on Probiotics for VAP



In our November 11, 2008 Patient Safety Tip of the Week “Probiotics and VAP Prevention” we noted a study that investigated the possible role of a novel therapy in the prevention of ventilator-associated pneumonia (VAP). Klarin and colleagues published this study on use of probiotics in intubated ICU patients in the online journal Critical Care. This was a randomized controlled trial in intubated, mechanically ventilated patients. Half received oral application of the probiotic lactobacillus Lp299 and the other half (control group) received chlorhexidine oral decontamination. Subsequent bacteriologic cultures of oropharyngeal or tracheal specimens failed to show any difference in potentially pathogenic bacteria between the probiotic group and the chlorhexidine group. No adverse effects were seen in the probiotic group. Note that this was a pilot study, intended to determine the power needed to study possible use of such probiotic therapy to prevent VAP.


Earlier this year a meta-analysis of randomized controlled trials of probiotics to prevent VAP (Siempos 2010a) concluded that they reduced the incidence of VAP and respiratory tract colonization but did not impact ICU or in-hospital mortality, duration of mechanical ventilation, or occurrence of diarrhea. Those conclusions were further debated in letters to the editor (van Silvestri 2010; Siempos 2010b) but both agreed further RCT’s were needed.


Now a new randomized controlled trial (Morrow 2010) showed that the probiotic Lactobacillus rhamnosus GG reduced VAP by 50% in a highly select ICU population at high risk for VAP. It also reduced the frequency of C. difficile associated diarrhea. No significant adverse effects were attributable to the probiotic treatment.


The authors caution against generalizing their results to all ICU patients because this was a highly select patient population. However, the potential implications are enormous. The probiotics cost only a few dollars a day and do not promote antibiotic resistance in the ICU. Look for further RCT’s looking at probiotics in a more diverse ICU population in the future. 






Klarin B, Goran Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Critical Care 2008, 12:R136 (6 November 2008)




Siempos, Ilias I.; Ntaidou, Theodora K.; Falagas, Matthew E.

Impact of the administration of probiotics on the incidence of ventilator-associated pneumonia: A meta-analysis of randomized controlled trials *

Critical Care Medicine. 38(3):954-962, March 2010




van Silvestri L, van Saene HK.; Gregori D. Probiotics to prevent ventilator-associated pneumonia: No robust evidence from randomized controlled trials.

Critical Care Medicine. 38(7): 1616-1617, July 2010.




Siempos II, Ntaidou TK, Falagas ME. Probiotics to prevent ventilator-associated pneumonia: No robust evidence from randomized controlled trials.

Critical Care Medicine. 38(7): 1617, July 2010




Morrow LE, Kollef MH, Casale TB.  Probiotic Prophylaxis of Ventilator-associated Pneumonia: A Blinded, Randomized, Controlled Trial.
Am. J. Respir. Crit. Care Med. 2010; published ahead of print on June 3, 2010 as doi:10.1164/rccm.200912-1853OC.






Print “July 2010 More on Probiotics for VAP





JCAHO Sentinel Event Alert On Violence in the Healthcare Setting



Joint Commission’s most recent Sentinel Event Alert is on Preventing Violence in the Health Care Setting. When we first read through it we weren’t overly impressed that it added a whole lot to just using common sense. However, when we actually walked through their checklist at one facility, it really did open our eyes. You’d be surprised how many of those “common sense” recommendations have not been implemented!


Many organizations provide training on de-escalation techniques for their behavioral health and emergency department staffs. However, how many of you provide it to your HR staff? And to your med/surg staff, who often have to deal with angry family members. Or your peds/ob staffs who may have to deal with broken families, custody disputes, etc. One can readily see there are a whole host of healthcare workers in our facilities who could benefit from such training in de-escalation techniques.


Most hospitals, particularly those with behavioral health units, have codes for summoning help in the event of an unruly patient. But how many have one dealing with a weapon situation or hostage situation? In the simple unruly patient scenario the code is usually calling for people to respond in person to the unit. But in the weapon/hostage situation you usually do not want additional physical presence of responders. In fact, the code tells them to stay away. When we asked staff about the latter, many were unaware that such a code even existed.


We found especially valuable their reference to ECRI’s “Violence in Healthcare Facilities”. When we did a hospital walk-thru and talked about where we might add additional surveillance cameras, almost everyone made the statement “just having dummy cameras is valuable”. However, ECRI actually discourages that, stating that “the false sense of security imparted by dummy cameras or unmonitored/malfunctioning real cameras has been the basis of many lawsuits.”


The ECRI paper also talks about a hospital developing a formal “family triage team”. That team responds to potentially violent situations and uses a 4-tiered tool to tie the response to the nature of the aggressive or agitated behavior being exhibited.


One area we particularly struggle with is the employee who is the victim of domestic violence or spousal abuse. Staff need to be well-trained to identify the signs and symptoms of domestic violence. While referring suspected victims to EAP programs should be done, there are also dangers to the facility if the abuser seeks out the victim in the workplace. The ECRI paper gives some practical advice on steps the healthcare facility can do in such circumstances.


In most cases where a worker in a healthcare facility perpetrates a violent act, there were warning signs that someone had notice beforehand but failed to pass that information on (just as with many serious adverse medical events someone knows something is wrong but does nothing about it for various reasons). There is, of course, a dilemma in that lawsuits have also often resulted from actions taken before violence has actually occurred.


The ECRI paper also has a good section on hostage situations.


In the event you have to evacuate your facility because of a violent event, you may find useful a couple guides just released in June by AHRQ. The Hospital Evacuation Decision Guide helps hospitals plan for an orderly evacuation both before an anticipated event (like a hurricane) and after the event in disasters to the hospital or surrounding community. The Hospital Assessment and Recovery Guide provides guidance on assessing the hospital for return and other issues related to recovery.






The Joint Commission. Sentinel Event Alert. Preventing violence in the health care setting. Sentinel Event Alert 2010; Issue 45 June 3, 2010




ECRI Institute. Healthcare Risk Control System.Violence in Healthcare Facilities. Health Care Risk Control. September 2005




AHRQ. Hospital Evacuation Decision Guide.




AHRQ. Hospital Assessment and Recovery Guide.





Print “July 2010 JCAHO Sentinel Event Alert on Violence in the Healthcare Setting




Obstructive Sleep Apnea in the General Inpatient Population


We’ve talked previously about some of the dangers of obstructive sleep apnea (OSA) in the postoperative period (see June 10, 2008 Patient Safety Tip of the Week “Monitoring the Postoperative COPD Patient” and our August 18, 2009 Patient Safety Tip of the Week “Obstructive Sleep Apnea in the Perioperative Period”.)


And we’ve talked about some of the screening tools for identifying potential cases of obstructive sleep apnea (see our May 6, 2008 Patient Safety Tip of the Week “Preoperative Screening for Obstructive Sleep Apnea”). That study highlighted use of the STOP questionnaire, based on the following the four questions:

  S   “Do you snore loudly?”

  T   “Do you often feel tired, fatigued or sleep during daytime?”

  O   “Has anyone ever observed you stop breathing during your sleep?”

  P   “Do you have or are you being treated for high blood pressure?”


A new study using the STOP and Berlin questionnaires found a potential 60% prevalence of obstructive sleep apnea in patients admitted to general medicine units in an urban academic hospital, most of whom had never been diagnosed with OSA. Many of the patients were obese and most had comorbidities. A high percentage of these patients received intravenous narcotics or were prescribed benzodiazepines or both and none of these received any supplemental respiratory monitoring. The study highlights the risk of using such medications in potentially high risk patients and also highlights the potential benefits of using simple tools like STOP in identifying potential OSA candidates.



Update: See our November 2010 What’s New in the Patient Safety World column “More on Preoperative Screening for Obstructive Sleep Apnea





Obstructive Sleep Apnea Prevalent in the Hospital Setting

Jim Kling. Medscape June 15, 2010





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




Methotrexate Overdose Due to Prescribing Error


A recent lawsuit alleges that an elderly patient with rheumatoid arthritis was erroneously prescribed a methotrexate dose on a daily basis instead of the weekly basis for which it was intended. The erroneous dosage was apparently also then continued when the patient was transferred to a longer term care facility. This is not the first time we have seen this scenario. And, in fact, ISMP did a Medication Safety Alert on this issue back in 2002 and another alert in 2009.


Methotrexate is used for treating a variety of conditions. In some, for example oncology conditions, it might be used daily. But for others, such as rheumatoid arthritis where it is used as an immunomodulating agent, it is usually given weekly. The errors often occur during the medication reconciliation process. Typically, methotrexate is initially prescribed by a specialist. But the patient is then admitted to either an acute care hospital or a long-term care facility and the dose is mistakenly written as a daily rather than weekly dose.


ISMP had some good recommendations in their 2002 alert. They recommend use of alerts in electronic prescribing systems and pharmacy computer systems to flag orders written for daily methotrexate to be reviewed for correctness. (This, by the way, is a great example where systems mandating entry of the indication for a drug could be very useful.). They also caution that computer systems should avoid default daily regimens for methotrexate. They recommend the pharmacist should do a prospective review before the medication is dispensed, including checking the indication for the drug, the dosage, the dosing schedule, the appropriate monitoring, and the appropriate education of the patient and caregivers. They also recommend that there be outpatient counseling of patients and that outpatient pharmacies should flag the medication so that this counseling takes place when the patient comes in to pick it up. They also recommend that the instructions on the label specify which day of the week the patient should take the methotrexate and the patient should be educated about what to do in the event of a missed dose. Be especially careful that any printed materials provided for patients have the correct weekly wording. Be particularly careful in cognitively impaired patients. Using dose packs may also reinforce the weekly dosing regimen. For those patients discharged from the hospital on methotrexate, ISMP recommends a followup phone call a day or two after discharge to ensure the patient is taking the methotrexate (and other medications) correctly.





Roche WF. Lawsuit claims dosage error at UPMC Passavant led to death. Pittsburgh Tribune-Review. June 10, 2010



ISMP. Beware of erroneous daily oral methotrexate dosing. ISMP Medication Safety Alert. Acute Care Edition. April 3, 2002 issue



ISMP. Methotrexate Overdose. ISMP Medication Safety Alert. Acute Care Edition. April 23, 2009 issue





Print “July 2010 Methotrexate Overdose Due to Prescribing Error





Cochrane Review: Oxygen in MI


In several of our prior columns on use of oxygen (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!”) we have commented that in the past we often routinely gave oxygen to patients with myocardial infarction or stroke. But such use was more reflexive in nature and not necessarily evidence-based.


Now a new Cochrane Review suggests that not only is oxygen not likely beneficial in acute MI patients, it may even cause harm. They reviewed the literature but could find only 3 randomized trials of oxygen vs. room air in MI patients. Only 387 patients were included in these 3 trials and only 14 patients died. The pooled relative risk for death was almost 3.00 in the oxygen group but the confidence interval was wide. The authors conclude that there is no evidence to support the routine use of oxygen in the acute MI patient. They suggest that the issue of whether oxygen is harmful could only be answered in a more definitive randomized trial.


This Cochrane Review certainly challenges many existing clinical guidelines for management of acute MI. Many standardized order sets for MI include routine use of oxygen. We concur with the authors that a definitive randomized trial is needed. But will it get done? We doubt it. Since there is no potentially lucrative drug patent here there won’t be pharmaceutical funding for such a trial. And the suppliers of oxygen are unlikely to fund a trial that has the potential to significantly reduce use of oxygen. This, however, is a good candidate for funding under the “comparative effectiveness” parts of the healthcare reform bill.


So what do we do in the interim? At least one editorialist (Atar 2010) argues that the quality of the studies included in the Cochrane review was poor and that the study did not conclusively demonstrate increased mortality from oxygen. He states that what we know about the physiology of myocardial ischemia, with no strong current evidence of a deleterious effect of oxygen, still merits treatment of MI patients with oxygen. Of course a similar argument has been used for the use of hi-dose oxygen in post-cardiac arrest patients and recent studies have now demonstrated a deleterious effect of oxygen in that setting (Kilgannon 2010). So stay tuned.





Cabello JB, Burls A, Emparanza JI, Bayliss S, Quinn T.

Oxygen therapy for acute myocardial infarction. Cochrane Reviews 2010; Published online June 16, 2010




Atar D. Should oxygen be given in myocardial infarction? BMJ  2010; 340: c3287 (Published 17 June 2010)




Kilgannon JH, Jones AE, Shapiro NI et al. Association Between Arterial Hyperoxia Following Resuscitation From Cardiac Arrest and In-Hospital Mortality
JAMA. 2010; 303(21): 2165-2171





Print “July 2010 Cochrane Review: Oxygen in MI








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

Print “July 2010 More on Probiotics for VAP

Print “July 2010 JCAHO Sentinel Event Alert on Violence in the Healthcare Setting

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

Print “July 2010 Methotrexate Overdose Due to Prescribing Error

Print “July 2010 Cochrane Review: Oxygen in MI














Patient Safety Tip of the Week Archive


What’s New in the Patient Safety World Archive