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What’s New in the Patient Safety World

January 2020


·       ISMP Canada: Change Management to Prevent Recurrences

·       FDA Warning on Gabapentinoids

·       The Joint Commission on Closing the Loop

·       Opioids and Apnea: Not Just Surgical Patients



ISMP Canada: Change Management to Prevent Recurrences



Lots of work gets done on root cause analyses (RCA’s). But then we often fail to undertake the necessary steps to ensure that any solutions or interventions or strategies we recommended actually take place and are effective.


ISMP Canada recently had a simple, but practical, article on change management (ISMP Canada 2019). They described the steps taken by a hospital in response to two fatal pediatric incidents involving concentrated potassium solutions. One incident involved the inadvertent use of concentrated potassium phosphate solution to flush an intravenous line; the other involved a preparation error that resulted in the patient receiving 10 times the required amount of potassium chloride intravenously.


The key steps in any change management program include:

-        Recognizing the need for change

-        Building a multidisciplinary team to guide change

-        Developing strategies to reinforce change

-        Communicating strategies to promote buy-in

-        Anchoring the change in organizational policies and procedures

-        Incorporating continuous monitoring and assessment



Recognizing the need for change

In the case presented, there was a compelling story that change was needed. But that is not always the case. You’ve heard us over and over stress “stories, not statistics”. People are much more likely to recognize the need to change when they hear a compelling story that makes them say “Wow. That could happen here!” It’s easier to make everyone recognize the need for change when a serious incident occurs at their facility. But telling a heartfelt story about a serious incident at another organization can also make everyone recognize the need for change. We find it particularly helpful when a healthcare worker involved in one of those serious incidents can tell their story about how it affected them as well as the patient or family involved.



Building a multidisciplinary team to guide change

Since change management almost always involves change at every level of your organization, it is key to assemble a multidisciplinary team truly representative of stakeholders. Not only are multiple stakeholders likely to contribute to development of change strategies, but they are also more likely to facilitate buy-in from their respective disciplines once you have developed change strategies.



Developing strategies to reinforce change

Sounds like the obvious next step. But be careful not to jump right in. Those of you involved in quality improvement who use the model espoused in The Improvement Guide (Langley 1996) know that the key question after you identify something you want to change is “How will we know that the change is an improvement?”, i.e. how will we measure the effects (both intended and unintended) of our efforts.


The three fundamental change questions (Langley 1996):

-        What are we trying to accomplish?

-        How will we know that a change is an improvement?

-        What changes can we make that will result in improvement?


Remember also that there is a hierarchy of actions that are likely to help you succeed in fixing your problem. We hope you’ll go back to our March 27, 2012 Patient Safety Tip of the Week “Action Plan Strength in RCA’s” for a discussion of which actions are likely to be successful and which are not. That column includes a link to our more graphic representation of action plan strengths.


At the hospital discussed in the ISMP Canada bulletin, one of the key goals was to reduce individualized prescriptions for intravenous electrolyte solutions (which were necessitating the use of concentrated electrolyte solutions). Strategies developed to support this goal included targeting different aspects of the medication-use process and engaging multiple health care providers. For example, preprinted and computerized order sets were modified to support the safe prescribing of electrolytes by including alternatives to intravenous electrolytes for certain clinical situations.


You should all recognize that the strongest actions are restraints and forcing functions. To prevent accidents with concentrated electrolyte solutions, the strongest action is to remove such solutions from any area that does not have an absolute need for them. That may have prevented the first described incident (where a concentrated potassium solution was inadvertently used to flush an IV line). But in the second incident, the pharmacy would have needed access to the concentrated solutions in order to prepare the prescribed electrolyte solution.


Communicating strategies to promote buy-in

The ISMP Canada bulletin has a really important point here: involvement of direct care providers, as well as managers and administrators, contributes to staff empowerment and promotes buy-in for the change.


It then notes that change strategies should include appropriate education and training for all those involved. Be careful there. If you looked at our slide set mentioned above, you’d have seen that education and training rank as the least effective actions. While education and training are necessary in most change projects, they should never be your sole or most important action. Timely in that regard is an excellent recent editorial by Soong and Shojania “Education as a low-value improvement intervention: often necessary but rarely sufficient” (Soong 2019). It describes several scenarios and how education fits in with each.


Perhaps the real goal of communication strategies is to generate buy-in. As we have stressed over and over, you need to look for noise any time you are promoting a change project. By “noise” we mean sentiment against change. That may be overt or covert. The grumbling in your medical staff lounge is important. We always say “If you do not encounter noise early on, your change project is doomed.” You need to recognize such sentiment and work to make all stakeholders recognize why the change is needed and how the recommended actions will help achieve the desired goals.



Anchoring the change in organizational policies and procedures

The ISMP Canada bulletin notes that change must be anchored within the organizational culture, and the new standard of practice must be sustained through regular reinforcement, which may include celebration of each successful step in the process of change.



Incorporating continuous monitoring and assessment

As we noted above the key question after you identify something you want to change is “How will we know that the change is an improvement?”. So, you should have developed a measurement strategy that will assess your progress toward meeting the new goals. And, equally important, you must be vigilant for unintended consequences. Even the best thought-out strategies often lead to unintended consequences that may be detrimental.


Sometimes it is difficult to measure some undesirable outcomes. For example, in the ISMP Canada scenario, you don’t want to have any incidents related to concentrated electrolyte solutions. So, you may have to look at surrogate measures. The hospital in the ISMP Canada article measured use of vials of concentrated potassium solutions, looking for a reduction in such use.



There’s nothing new and earth-shattering in the ISMP Canada article. But it serves as a good reminder about facilitators and barriers to any change management project.




Some of our prior columns on RCA’s, FMEA’s, response to serious incidents, etc:

July 24, 2007              “Serious Incident Response Checklist

March 30, 2010           “Publicly Released RCA’s: Everyone Learns from Them

April 2010                   “RCA: Epidural Solution Infused Intravenously

March 27, 2012           “Action Plan Strength in RCA’s

March 2014                 “FMEA to Avoid Breastmilk Mixups

July 14, 2015              “NPSF’s RCA2 Guidelines

July 12, 2016              “Forget Brexit – Brits Bash the RCA!

May 23, 2017              “Trolling the RCA

October 2019               “Human Error in Surgical Adverse Events






ISMP Canada. Change Management in Response to Preventable Tragedies. ISMP Canada Safety Bulletin 2019; 19(10): 1-5 December 12, 2019



Langley GJ, Nolan KM, Nolan TW, Norman CL, Provost LP, The Improvement Guide. A Practical Approach to Enhancing Organizational Performance. San Francisco: Jossey-Bass Publishers, 1996



Soong C, Shojania KG. Education as a low-value improvement intervention: often necessary but rarely sufficient. BMJ Quality & Safety 2019; Published Online First: 16 December 2019





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FDA Warning on Gabapentinoids



In the past 2 years we’ve done a couple columns on dangers of gabpentinoids, alone or in combination with opioids (see our What's New in the Patient Safety World columns for November 2017 “Bad Combination: Gabapentin and Opioids” and March 2019 “Gabapentin and Pregabalin on the Radar Screen”). So, it comes as no surprise to us that the FDA has just issued a warning about gabapeninoids (FDA 2019).


The FDA warns that “serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease (COPD) that reduce lung function. The elderly are also at higher risk.”


The FDA notes that gabapentinoids are often being combined with CNS depressants (including opioids, anti-anxiety medicines, antidepressants, and antihistamines), which increases the risk of respiratory depression. It acknowledges that there is less evidence supporting the risk of serious breathing difficulties in healthy individuals taking gabapentinoids alone.


The FDA decision was based upon both reports it received and studies in the medical literature. Of fatal cases involving gabapentinioids reported to the FDA, all had at least one additional risk factor.


They reviewed results of two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals.


The FDA cautions both patients and healthcare professionals that this evidence is “contrary to the widely held belief that gabapentinoids lack drug interactions and have wide therapeutic indices”. It notes that published studies demonstrate these drugs can behave in an additive way to potentiate central nervous system (CNS) and respiratory depression.


Use of gabapentinoids has increased dramatically in recent years. The FDA notes that. between 2012 and 2016, the number of patients who filled a gabapentin prescription increased from 8.3 million to 13.1 million annually, and the number of patients who filled a pregabalin prescription increased from 1.9 million to 2.1 million annually. Also, a 2016 office-based physician survey showed that 14 percent and 19 percent of patient encounters involving gabapentin and pregabalin, respectively, also involved opioids.


Gabapentinoids have been important drugs in managing seizure disorders and chronic pain. But they have also been used for a variety of off-label conditions and a recent systematic review of gabapentinoid (pregabalin and gabapentin) abuse (Evoy 2017) found that increasing numbers of patients are self-administering higher than recommended doses to achieve euphoric highs.


Note that this year’s Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults (AGS 2019) also specifically mentioned the dangers of drug-drug interactions between opioids and gabapentinoids. They noted these drug interactions are problematic in all persons, but are growing increasingly common and may lead to greater harm in vulnerable older adults.


The problems related to gabapentinoids have attracted attention not only in the US, but in other countries as well. Our March 2019 What's New in the Patient Safety World column “Gabapentin and Pregabalin on the Radar Screen” discussed multiple studies from Australia and Sweden. The Medical Council of Ireland has also recently issued a warning about gabapentinoids (Medical Council of Ireland 2019). While that warning focused primarily on benzodiazepines and z-drugs, it also called out Pregabalin. A recent population-based study from Sweden (Molero 2019) suggests that gabapentinoids are associated with an increased risk of suicidal behavior, unintentional overdoses, head/body injuries, and road traffic incidents and offenses. Pregabalin was associated with higher hazards of these outcomes than gabapentin.


In our March 2019 What's New in the Patient Safety World column “Gabapentin and Pregabalin on the Radar Screen” we cautioned that prescribers need to be aware that concomitant use of pregabalin and opioids or sedating agents may be dangerous and that we need to use our CPOE and e-prescribing systems to alert prescribers when such combinations are in play. But keep in mind that IT interoperability issues may be problematic when drugs are prescribed or dispensed by different healthcare professionals.




Our previous columns on dangers of gabpentinoids alone or in combination with opioids:


·       November 2017          “Bad Combination: Gabapentin and Opioids

·       March 2019                  “Gabapentin and Pregabalin on the Radar Screen






FDA (US Food and Drug Administration). FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)When used with CNS depressants or in patients with lung problems12-19-2019



Evoy KE, Morrison MD, Saklad SR. Abuse and misuse of pregabalin and gabapentin. Drugs 2017; 77: 403-426



2019 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults. J Amer Geriatr Soc 2019; First published: 29 January 2019



Medical Council of Ireland. Medical Council Warns Doctors to Reduce Over-Prescribing of Benzodiazepines. Medical Council Warns Doctors to Reduce Over-Prescribing of Benzodiazepines, Z-drugs and Pregabalin or face Potential Investigation. Medical Council of Ireland (press release) 2019; September 19, 2019



Molero Y, Larsson H, D’Onofrio BM, et al. Associations between gabapentinoids and suicidal behaviour, unintentional overdoses, injuries, road traffic incidents, and violent crime: population based cohort study in Sweden. BMJ 2019; 365: l2147






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The Joint Commission on Closing the Loop



The Joint Commission recently issued one of its “Quick Safety” alerts on a topic near and dear to us: failure to close the loop on studies ordered (TJC 2019). Our many columns, listed below, highlight serious patient injuries occurring when significant test or imaging findings are not promptly conveyed to responsible physicians or to patients. There are many reasons, related to both human factors and system issues, that significant results “fall through the cracks”. Responsibility to ensure closing the loop is the responsibility of the ordering physician, the radiologist/imager (or lab for lab test results), the physician primarily responsible for management of the patient, and the patient him/herself.


The new Joint Commission Quick Safety alert (TJC 2019) begins with a case vignette in which a woman undergoes mammography that has suspicious findings. But these slip through the cracks until a year later, at which time her lesion had grown significantly, and she now required surgery, chemotherapy and radiation for advanced breast cancer.


Contributing factors included:

-        Her PCP was not on the same electronic medical record (EMR) as the imaging center

-        There were also front office changes

-        As a result. the PCP missed the notification to follow up

-        The patient was told that the radiologist would contact her if the results were abnormal; otherwise, it was safe to assume that things were normal

-        Since the patient never received a follow-up call, she thought she was okay.

-        The radiologist responsible for making follow-up calls worked from a printed list and had received only Page 1 of the month’s list; Page 2, which included the patient’s name, did not get transmitted to the radiologist.

The Joint Commission Quick Safety alert focuses on a tool to help reduce patient safety incidences during the diagnostic process. That tool, the Improving Diagnosis in Medicine Change Package, is the result of a collaboration between the Health Research & Educational Trust (HRET) Hospital Improvement Innovation Network (HIIN) and the Society to Improve Diagnosis in Medicine (SIDM), with contributions by patients and their families. They also link to the “Health IT Safe Practices for Closing the Loop. Mitigating Delayed, Missed, and Incorrect Diagnoses Related to Diagnostic Testing and Medication Changes Using Health IT” (ECRI 2018) that we discussed in our September 2018 What's New in the Patient Safety World column “ECRI Institute Partnership: Closing the Loop” and the SAFER guidelines (ONC 2016) that we’ve referenced in several columns.


Recommendations in this Quick Safety alert include:

-        Identify workflows that are particularly vulnerable to mishandling of test results, and develop back-up procedures to ensure test results are received by someone responsible for the affected patient's care. These procedures should address handoffs between clinicians and care transitions between clinical settings. 

-        Establish consistent processes to ensure that test results are communicated to a clinician responsible for follow-up care.

-        Notify patients of life-threatening test results through verbal means and ensure positive confirmation of receipt.

-        Forward or escalate to an alternate responsible provider any abnormal test result that remains unacknowledged after a pre-specified time period.

-        Ensure that test results are communicated to a back-up provider in a timely fashion in the event that the ordering provider is not available. The necessary timeliness is dependent on the significance of the test result.

-        Optimize your organization’s health information technology (IT) capabilities to communicate test results. Health IT can be used to automate the abovementioned actions and help measure effectiveness.

-        Improve your organization’s patient portal(s) to help patients access test results and better track their medical histories.

They note that, while many patients find the portals confusing and lacking important context for test results, there are some ways to improve them, including:

-        Ensure the portal is accessible on both large-format computers and hand-held devices.

-        Provide and promote patient access to EHRs, optimally including real time clinical notes and diagnostic testing results.

-        Explain the test results directly in the portal.

-        Provide patients easy access to support services as needed for action and follow up.

-        Give patients personalized or contextual information to help them understand what to do with the results.

-        Create consensus and standards on timing and best practices for the portal’s release of normal and abnormal test results.


However, the Quick Safety alert goes on to caution clinicians not to assume their patients will make use of online portals. It notes that some patients may be uncomfortable or unversed in online portals and would prefer direct person-to-person communication. Clinicians should not rely solely on the portals to communicate abnormal test results and contact their patients directly when action is necessary.


A few of our own additional recommendations:

-        Never, ever, tell a patient they will be contacted if their results are abnormal. No news is not good news! They need to know when to expect the results and what to do if they have not been contacted about those results by that time.

-        Ask your patient what their preferred method of receiving test results is, keeping in mind that there are certain test results you will want to convey to them verbally yourself (either face-to-face or by phone).

-        Make sure you have a system (a “tickler” file) that alerts you to any test results you have not yet seen.

-        Every imaging practice must have a system in place, in which they identify “significant” findings and have a way to ensure the patient is made aware of those findings. Many states may adopt the mandate we described in our November 26, 2019 Patient Safety Tip of the Week “Pennsylvania Law on Notifying Patients of Test Results”.

-        Pay particular attention to high-risk scenarios, like tests pending at hospital discharge (or ER discharge) or tests pending as you go on vacation.



See also our other columns on communicating significant results:






TJC (The Joint Commission). Quick Safety 52: Advancing safety with closed-loop communication of test results. The Joint Commission 2019



“Improving Diagnosis in Medicine” Change Package



HRET (Health Research & Educational Trust). Improving Diagnosis in Medicine. Diagnostic Error Change Package. Health Research & Educational Trust. September 2018



Partnership for Health IT Patient Safety. Health IT Safe Practices for Closing the Loop. Mitigating Delayed, Missed, and Incorrect Diagnoses Related to Diagnostic Testing and Medication Changes Using Health IT. ECRI Institute 2018



ONC (Office of the National Coordinator for Health Information Technology). SAFER GUIDES—Safety Assurance Factors for EHR Resilience. Test Results Reporting and Follow-Up. ONC 2016; September 2016





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Opioids and Apnea: Not Just Surgical Patients



Opioid-induced respiratory depression in patients with obstructive sleep apnea (OSA) has been the topic of many of our columns. But we’ve most often discussed this in relation to patients undergoing surgery. But medical patients are also at risk. In our May 6, 2014 Patient Safety Tip of the Week “Monitoring for Opioid-induced Sedation and Respiratory Depression” we noted a study (Herzig 2014) that showed over half (51%) of non-surgical inpatients receive opioids, often in high doses. And many nonsurgical patients also have a high risk of known or undiagnosed OSA.


Results of the OpiatesHF Study were just published (Niroula 2019). This study looked at a population known to have a high prevalence of sleep disorder breathing (SDB) – those hospitalized with acute heart failure. Notice we said sleep disordered breathing rather than obstructive sleep apnea. That’s because many patients with acute heart failure may have central sleep apnea or Cheyne-Stokes breathing or obstructive sleep apnea.  In the OpiatesHF Study, 54% had predominantly central apnea or Cheyne-Stokes breathing and 46% had predominantly obstructive sleep apnea.


The study looked at a sequential group of over 300 patients hospitalized with acute heart failure, who received a portable sleep study (PSS) after screening for SDB using the STOP-BANG questionnaire. The researchers then did a retrospective review of charts to assess use of opiates, need for escalation of care (defined as transfer to the intensive care unit), 30-day readmission, and length of stay.


Overall, 41.5% received opiates in the hospital, and 49.5% patients had an AHI (apnea/hypopnea index) greater than or equal to 10/h by PSS (high risk of SDB). In this high-risk group, 32% received opiates. Among those with an AHI greater than or equal to 10/h, escalation of care occurred in 26% of those who received opiates versus 4% of those who did not. Readmission within 30 days occurred in 15% of those who received opiates versus 9% of those who did not, though that difference did not meet statistical significance. Mean LOS did not differ significantly between groups.


The key finding of this study is that use of opioids in this patient population can be dangerous and should be avoided but also that careful monitoring is needed when opioids are necessary. As per our usual recommendations, that should include not just pulse oximetry but also apnea monitoring and capnography. The study also notes the utility of screening patients with the STOP-BANG questionnaire and perhaps doing a portable sleep study to further risk-stratify patients.


Apparently, opioids were most often used in these patients for comorbid conditions, like arthritis or back pain, and had often been used prior to admission. Some who were recognized to be at high risk might be considered for discontinuation of outpatient opioids and/or considered for CPAP, where appropriate based on results of a sleep study.


But the study also raises one other important issue. Low-dose opioids are often used in palliative care to reduce the sensation of dyspnea or breathlessness, and more and more patients with heart failure are in palliative care programs. The OpiatesHF Study did not specifically look at the correlation between opioid dose and outcomes, but it is known that the impact of opioids on SDB is dose-dependent. It would be of interest to see whether risk stratification (by presence or absence of SDB) is of benefit in heart failure patients receiving palliative care.


The OpiatesHF Study serves as a reminder that opioid use is common in nonsurgical patients admitted to the hospital and that many, particularly those with acute heart failure, also have sleep disordered breathing that may put them at risk if opioids are given.




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









Herzig SJ, Rothberg MB, Chekung M, et al. Opioid utilization and opioid-related adverse events in nonsurgical patients in US hospitals. Journal of Hospital Medicine 2014; 9(2): 73-81



Niroula A, Garvia V, Rives-Sanchez M, et al. Opiate Use and Escalation of Care in Hospitalized Adults with Acute Heart Failure and Sleep-disordered Breathing (OpiatesHF Study). Ann Am Thorac Soc 2019; 16(9): 1165-1170






Print “January 2020 Opioids and Apnea: Not Just Surgical Patients




Print “January 2020 What's New in the Patient Safety World (full column)

Print “January 2020 ISMP Canada: Change Management to Prevent Recurrences

Print “January 2020 FDA Warning on Gabapentinoids

Print “January 2020 The Joint Commission on Closing the Loop

Print “January 2020 Opioids and Apnea: Not Just Surgical Patients





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