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What’s New in the Patient Safety World

March 2022



·       MedSafer: Glass Half-Empty or Half-Full?

·       Urinary Catheter Reinsertion

·       Predicting C. diff Infection in Just 6 Hours?

·       The Annual Top 10 Lists Begin




MedSafer: Glass Half-Empty or Half-Full?




We’ve done many columns on PIM’s (Potentially Inappropriate Medications) in the elderly and many on deprescribing. But does deprescribing actually translate into fewer adverse drug events (ADE’s)? The MedSafer Study was a study on electronic decision support for deprescribing in hospitalized older adults intended to answer this question.


MedSafer was a cluster randomized clinical trial of older (≥65 years) hospitalized patients with an expected survival of more than 3 months who were admitted to 1 of 11 acute care hospitals in Canada (McDonald 2022). Participants were taking 5 or more medications per day at the time of admission. Reports of deprescribing opportunities generated by MedSafer software were based on patients’ usual home medications and measures of prognosis and frailty.


Almost 6000 patients were enrolled. Deprescribing increased from 29.8% in control patients to 55.4% in intervention participants. There was no difference in adverse drug withdrawal events between groups. However, there was no significant difference in the primary outcome, ADE’s within 30 days of discharge (5.0% in controls vs 4.9% in intervention participants). The incidence of postdischarge falls did decrease but not statistically significantly (odds ratio, 0.76). Sleep and quality of life remained stable before and after hospitalization.


One problem was that, despite cluster randomization, groups were not balanced (participants in the intervention arm were older and had more PIMS prescribed at baseline). But sensitivity analyses, including addressing those imbalances, did not alter study conclusions.


The researchers had used a historical rate of ADE’s in the first 30 days following deprescribing to establish the power of the study. That rate, taken mostly from studies done more than 15 years ago, was 10 to 15%. But the rate of these ADE’s in both arms of the current study was much lower (5% and 4.9%). The authors also note that widespread hospital pharmacist involvement in medication reconciliation has created opportunities to mitigate more worrisome prescribing practices, such as errors of omission, which may lead to clearly identifiable ADE’s.


The authors also note that, while the intervention identified numerous deprescribing opportunities, many were for low-risk nonbeneficial polypharmacy (eg, nonstatin cholesterol-lowering medications or stool softeners) and deprescribing these medications is less likely to impact 30-day ADE’s. But that still has both patient and societal value (avoiding excess cost, waste, pill burden, etc.).


The authors had many suggestions for future studies on the impact of deprescribing on ADE’s (eg. more prolonged duration, focus on more high-risk PIM’s, etc.).


In sum, the study found that providing deprescribing decision support to the acute care medical teams did not impact 30-day ADE rates. But it did effectively stop many PIM’s, and did so safely, with no evidence of increased harm. So, is the glass half empty, or half full?



Some of our past columns on deprescribing:




Some of our past columns on Beers’ List and Inappropriate Prescribing in the Elderly:







McDonald EG, Wu PE, Rashidi B, et al. The MedSafer Study—Electronic Decision Support for Deprescribing in Hospitalized Older Adults: A Cluster Randomized Clinical Trial. JAMA Intern Med 2022; Published online January 18, 2022





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Urinary Catheter Reinsertion



In our many columns on CAUTI’s (catheter-associated urinary tract infections) there is one topic we have seldom discussed – reinsertion of urinary catheters. A recent study by researchers at Henry Ford Hospital (Jamil 2022) brought that issue to our attention.


While we have focused efforts on avoiding urinary catheters that don’t meet criteria, Jamil et al. point out that it is estimated 25%-45% of adult patients will have an indwelling urinary catheter inserted at some point during their hospitalization, with rates as high as 89% for patients within the ICU. And we’ve also focused efforts on prompt removal of those catheters once they no longer meet criteria for continued use. But what happens once we remove those catheters?


The researchers developed a post-catheter removal bladder management protocol referred to as the Urinary Catheter Alleviation Navigator Protocol (UCANP) and piloted this protocol on four units, a neuro-intensive care unit, 2 neurosurgical and/or neurologic step-down units, and a neurosurgical and/or neurologic general practice unit.


The protocol: After catheter removal, a post-void residual (PVR) was obtained if a spontaneous void occurred within the first 4 hours. Patients with a PVR ≤ 100 mL “graduated” from the post-catheter removal management protocol. Patients with a PVR ≥ 400 mL were initiated on the intermittent catherization pathway. Patients with a PVR between 100 and 400 mL were monitored with repeat bladder scans every 4 hours and followed the protocol suggested pathway depending on the repeat bladder scan volumes. Patients who did not spontaneously void within 4 hours or had a PVR ≥ 400 mL were started on the intermittent catherization pathway. Patients would undergo nurse-conducted intermittent catherization for 48 hours. If they were unable to void spontaneously by that time, the primary medical and nursing team would evaluate the patient’s cognitive and physical ability, family support status, post-discharge location (home vs skilled nursing center, long term acute care center, sub-acute rehab center etc.), and ability to continue self or care-assisted intermittent catherization after discharge.


After implementation of the protocol, the reinsertion rate of 16% was compared to 21% and 27% in the pre-pilot cohort and another historical cohort, respectively. The mean number of catheter days was significantly lower during the protocol period (1.4 days) compared to the pre-pilot (5.6 days) and other historical (9.5 days) cohorts (P = .006).  Rates of CAUTI’s were 0.6% during the pilot, compared to 1.2% in the pre-pilot cohort and 1.7% in the other historical cohort. Investigated in a larger patient population would be required to assess statistical significance regarding reduction in CAUTI’s.


Successful implementation of the protocol looks like it drew upon many of the success factors from the Michigan Keystone Project. All medical personnel (physicians, nurses, nursing assistants) were provided educational material and instructions on the outlined protocol. Comprehensive Unit-Based Safety Program (CUSP) principles were used and debriefings were held every 3 weeks by clinical leadership. The EMR was used for both order entry and tracking of patients, with reminders and instructions for nursing staff about next steps in the protocol.


We think this is an exciting study. If it results in reductions in catheter days of this magnitude in other populations and settings, we’d expect a significant reduction in CAUTI’s.



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







Jamil ML, Wurst H, Robinson P, et al. Urinary catheter alleviation navigator protocol (UCANP): Overview of protocol and review of initial experience. AJIC 2022; 50(1): 81-85




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Predicting C. diff Infection in Just 6 Hours?



What if you could accurately predict in a timely fashion which of your hospitalized patients were likely to develop C. diff (Clostridiodes difficile) infection? You could institute prophylactic measures, make the diagnosis earlier, and implement infection control measures in a more timely fashion.


A new study looked at the ability of machine learning algorithms to predict which hospitalized patients will become infected with C. diff (Panchavati  2022). The study used electronic health record data from several hospitals to develop 3 machine learning algorithms and then tested the algorithms using data 1,149,088 inpatient encounters with 7,107 CDI (C. diff infection) encounters at other hospitals. They found that machine learning algorithms can predict future CDI in hospitalized patients using just the first 6 hours of inpatient data!


You’ll have to read the publication itself for details of each of the 3 machine learning algorithms and all the incorporated data elements. Age was one of the most important features in generating predictions in each of the 3 machine learning algorithms. Other data elements that were important predictors were sodium, BMI, white blood cell count, bilirubin, heart rate, diastolic blood pressure, active medication treatment with antibiotics or proton pump inhibitors (PPI’s).


The size and breadth of underlying data was a major strength of the study. The data came from EMR’s at over 700 US hospitals. The development dataset contained 13,664,840 inpatient encounters with 80,046 CDI encounters and the external validation dataset used data on 1,149,088 inpatient encounters with 7,107 CDI (C. diff infection) encounters at other hospitals. And fact that all the data was easily gleaned from the EMR makes potential use of these machine learning algorithms very attractive.


While we’ve always been able to use many of the above risk factors to identify patients at risk of developing CDI, the accuracy of these machine learning algorithms has the potential to significantly impact our approach to CDI.



Some of our prior columns on C. diff infections:

·       August 2021               Updated Guidelines on C. diff

·       October 2021              HAI’s Increase During COVID-19 Pandemic





Panchavati S, Zelin NS, Garikipati A, et al. A comparative analysis of machine learning approaches to predict C. difficile infection in hospitalized patients. AJIC 2022; Published online: January 19, 2022





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The Annual Top 10 Lists Begin



This time of year, many organizations publish their “Top 10” lists of various problems in patient safety. You can go to the primary sources for details of what follows, but here are some of the early lists:



ECRI's Top 10 Health Technology Hazards for 2022 (ECRI 2022) are as follows:

1.     Cybersecurity Attacks Can Disrupt Healthcare Delivery, Impacting Patient Safety     

2.     Supply Chain Shortfalls Pose Risks to Patient Care          

3.     Damaged Infusion Pumps Can Cause Medication Errors                      

4.     Inadequate Emergency Stockpiles Could Disrupt Patient Care during a Public Health Emergency              

5.     Telehealth Workflow and Human Factors Shortcomings Can Cause Poor Outcomes

6.     Failure to Adhere to Syringe Pump Best Practices Can Lead to Dangerous Medication Delivery Errors       

7.     AI-Based Reconstruction Can Distort Images, Threatening Diagnostic Outcomes       

8.     Poor Duodenoscope Reprocessing Ergonomics and Workflows Put Healthcare Workers and Patients at Risk           

9.     Disposable Gowns with Insufficient Barrier Protection Put Wearers at Risk

10.  Wi-Fi Dropouts and Dead Zones Can Lead to Patient Care Delays, Injuries, and Deaths


ISMP’s Top 10 Medication Safety Concerns (ISMP 2022):

1.     Mix-ups between the pediatric and adult formulations of the Pfizer-BioNTech COVID-19 vaccines

2.     Mix-ups between the COVID-19 vaccines or boosters and the 2021-2022 influenza (flu) vaccines

3.     EPINEPHrine administered instead of the COVID-19 vaccine

4.     Preparation errors with the Pfizer-BioNTech purple cap or gray cap COVID-19 vaccines

5.     Errors and delays with hypertonic sodium chloride

6.     Errors with discontinued or paused infusions

7.     Infection transmission with shared glucometers, fingerstick devices, and insulin pens

8.     Adverse glycemic event errors

9.     Every organization needs a medication safety officer

10.  Increasing error reporting


Becker’s (Bean 2022) Top 5 top safety issues for hospitals to address in 2022:

1.     Foundational safety work

2.     Supporting the healthcare workforce

3.     Integrating equity into safety work

4.     Diagnostic harm

5.     Healthcare-associated infections


Leapfrog’s 3 top patient safety concerns right now (Masson 2022):

1.     Hospitals bringing in underqualified physicians because of staffing shortages.

2.     Significant rise in bacterial, fungal infections

3.     Practicing proper hand-hygiene monitoring


ISPOR’s (ISPOR 2022) Top 10 Health Economics and Outcomes Research Trends:

1.     Real-World Evidence

2.     Value Assessment

3.     Health Equity

4.     Healthcare Financing

5.     Patient Engagement

6.     Drug and Healthcare Pricing

7.     Public Health

8.     Health Technology Assessment

9.     Health Data

10.  Artificial Intelligence






ECRI. Top 10 Health Technology Hazards for 2022 Executive Brief. ECRI 2022



ISMP (Institute for Safe Medication Practices). Start the year off right by addressing these Top 10 Medication Safety Concerns from 2021. ISMP 2022; January 27, 2022



Bean M. 5 top safety issues for hospitals to address in 2022. Becker’s Hospital Review 2022; January 3rd, 2022



Masson G. 3 top patient safety concerns right now, per Leapfrog CEO. Becker’s Clinical Leadership & Infection Control 2022; January 25th, 2022



ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR). ISPOR 2022-2023 Top 10 HEOR Trends Report. ISPOR 2022






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Print “March 2022 What's New in the Patient Safety World (full column)

Print “March 2022 MedSafer: Glass Half-Empty or Half-Full?

Print “March 2022 Urinary Catheter Reinsertion

Print “March 2022 Predicting C. diff Infection in Just 6 Hours?

Print “March 2022 The Annual Top 10 Lists Begin



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