Capnography, Patient Monitoring, Patient Safety, Patient Stories

Sleep Apnea + Opiods = Post-Surgical Preventable Death

[Editor’s note: This article first appeared in The Doctor Weighs In. The team at Physician-Patient Alliance for Health & Safety thank Pat for her tremendous courage and working with us on this tragic story of what happened to her husband. We hope that in this retelling, hospitals will be encouraged to ensure that similar events become “never events”.]

By Patricia LaChance

After undergoing what most people would consider a routine surgery, my husband John, died. Just as heartbreaking as John’s passing was to me is the fact that his death was entirely preventable.

Please click on the picture to view the video about John.

Please click on the picture to view the video about John.

John died because his medical history was ignored and because he was not properly monitored after he was placed on a strong narcotic to ease the pain from his surgery to repair a torn rotator cuff in his shoulder.

That is the simple version of John’s story, but of course, there’s much more to it than that. Since he left us in March of 2007, I have come to learn a lot about what caused his death, and I want to share my experience so that other families, nurses, doctors and hospitals can prevent what happened to him.

John suffered from sleep apnea, which John and I thought at the time was merely a sleep issue. We had no idea it could also be a fatal issue.

John underwent two surgeries. His first was a same day surgery. After this first procedure, he experienced a great deal of trouble recovering from the anesthesia. He struggled for hours to wake up enough to be able to leave the hospital.  He was very groggy, nauseated and dizzy.

During the months that followed, he struggled with similar side effects from several narcotics that were prescribed for his pain management. He had two severe episodes at work – one he was able to sleep off at home; the other required an ambulance ride to the emergency room.

Six months later, John’s shoulder injury required a second repair. Immediately following this second surgery, John — like millions of Americans who undergo surgery — was placed on patient-controlled analgesia (PCA), commonly known as a “pain pump” that intravenously delivered opioid medication to help him manage his pain. We were familiar with PCA, but unaware of the dangers associated with it.

Prior to and following John’s second shoulder surgery, I discussed his opioid-intolerance and sleep apnea with all of his caregivers, but he was nevertheless placed on PCA. Once again, his body rejected the medication and became extremely ill.

Observing John’s discomfort, a nurse disconnected him from the PCA pump and directly administered Dylaudid, a stronger opioid. With the removal of the PCA pump, the Pulse Oximetry and supplemental oxygen were also removed. Within minutes, he seemed to be comfortable – comfortable to the point that he did not move or speak to me again – he just stared at the ceiling. I was concerned about his condition, but the nurse was not.

Thinking John was finally going to get some much needed rest at the end of a trying day, I kissed him on the forehead, told him that I loved him, and promised to return first thing in the morning to take him home.

But that isn’t what happened. In the early hours of the morning, John passed away.

With all my heart, I wish I had known that night what I have come to understand today: Patients receiving opioids after surgery – especially those with sleep apnea – are at very real risk of fatal respiratory depression.

That’s exactly what happened with John. He fell into a deep sleep, and was not able to awake. Because he was not monitored, his caregivers had no idea that he was in trouble.

This did not need to happen. If the hospital had used technology such as capnography and pulse oximetry to continually monitor John’s respiratory status, he would still be with me today.

John meant the world to me, our children and his family, and many friends. Together, we sincerely hope that other families never have to go through what we did. For that to happen, I strongly believe that there are two critical patient safety issues that our nation’s hospitals must immediately address:

  1. In far too many instances, post-surgical patients are placed on opioid therapy with little or no consideration given to their medical histories, especially as they relate to medication tolerance. When I recently spoke to the Maryland Association of Nurse Anesthetists, one of the points I made was that each individual patient needs to be assessed for medication intolerance. Not all patients can tolerate the same medications. Yet, my observation is that far too often, opioids are automatically the medication of choice, and the patient’s medical history is not taken into consideration. My husband is a prime example.
  1. Continuous monitoring of all post-surgical patients receiving opioids should be a national standard of care. Recently, the Centers for Medicaid Centers for Medicare & Medicaid Services (CMS) issued guidance recommending that patients receiving opioids after surgery should be continuously monitored for signs of respiratory depression.

The CMS guidance perhaps summarizes this best when it states:

Each year, serious adverse events, including fatalities, associated with the use of IV opioid medications occur in hospitals. Opioid-induced respiratory depression has resulted in patient deaths that might have been prevented with appropriate risk assessment for adverse events as well as frequent monitoring of the patient’s respiration rate, oxygen and sedation levels. Hospital patients on IV opioids may be placed in units where vital signs and other monitoring typically is not performed as frequently as in post-anesthesia recovery or intensive care units, increasing the risk that patients may develop respiratory compromise that is not immediately recognized and treated.

 

 

Capnography, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient Stories, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring, Postoperative Pain

PPAHS Mourns the Fourth Anniversary of the Passing of Amanda Abbiehl

by Sean Power
July 24, 2014

This past weekend (July 17) marks the anniversary of the tragic death of 18-year old Amanda Abbiehl, whose story serves as a powerful reminder of the need for continuous electronic monitoring.

Lynn Razzano, Clinical Nurse Consultant with the Physician-Patient Alliance for Health & Safety, offers an appeal to her clinical colleagues:

“On the four year anniversary of the untimely passing away of 18-year old Amanda, hospitals need to think of how this could have been actively prevented. My hope is that this promotes more vigilance in appropriately assessing a patient when opioids are in use and ensuring that all patients receiving opioids are continuously electronically monitored.

“The time is now to prevent death from opioid-induced respiratory depression. It is as easy as ensuring the order is placed for continuous monitoring whenever opioids are ordered. This should be the new current standard of practice and one that proactively prevents opioid deaths from occurring.”

Join us in making a #Promise to Amanda today.

Patient safety champions: Promise to do everything you can to make it mandatory at your hospital for all patients on PCA pumps to be continuously electronically monitored with capnography and pulse oximetry.

Nurses, physicians, and respiratory therapists: Encourage patients and families to share their experiences with respiratory monitoring. Promise to talk to decision makers about capnography and respiratory monitoring every chance you get. Use the PCA Safety Checklist before, during, and after initiating PCA treatment.

Hospital administrators: Build redundancies into the system. Mistakes are going to be made but adverse events are preventable. Monitor every patient and save lives. Tell us if your hospital monitors patients with capnography while they are connected to PCA pumps.

Patients and families: Come forward to share your story about capnography. Write, phone, or email your local congressperson about making zero preventable deaths a policy priority.

Read more about Amanda’s story at promisetoamanda.org or at WNDU’s latest coverage of the Promise to Amanda Foundation.

Capnography, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring, Postoperative Pain

PPAHS Joins Anesthesia Patient Safety Foundation in Call for a “Paradigm Shift” in Opioid Safety

by Sean Power
February 19, 2014

“It’s time for a change in how we monitor postoperative patients receiving opioids,” declares Dr. Robert Stoelting, president of the Anesthesia Patient Safety Foundation (APSF). “We need a complete paradigm shift in how we approach safer care for postoperative patients receiving opioids.”

The APSF recently released a video highlighting the conclusions and recommendations that came out of a 2011 conference on opioid-induced ventilatory impairment. You can find the video here.

In the video, APSF states that continuous electronic monitoring of oxygenation and ventilation, when combined with traditional nursing assessment and vigilance, will greatly decrease the likelihood of unrecognized, life threatening, opioid induced respiratory impairment.

The clinical significance continuous electronic monitoring offers is the opportunity for prompt and predictable improvement in patient safety.

According to Lenore Alexander, founder and executive director of Leah’s Legacy, a patient safety organization focused on safe opioid use:

“A monitor would have saved my child’s life. I have made the goal of continuous postoperative monitoring my commitment.

“All that stands between us and universal post op monitoring is the will to require it.”

In the APSF video, health experts warned of the risks of selectively monitoring some patients.

According to Nikolaus Gravenstein, MD, Professor of Anesthesia, University of Florida School of Medicine, APSF Committee on Technology:

“Who should be monitored electronically? I would say any inpatient but certainly any inpatient prescribed narcotics, because if they are prescribed they can be received.”

According to Michael DeVita, MD, Critical Care Medicine, St. Vincent’s Hospital:

“You need to absolutely require a continuous monitoring system if it’s your goal to prevent every possible death. Who should be monitored? Everyone.”

Mark Montoney, MD, MBA, Executive Vice President and Chief Medical Officer, Vanguard Health Systems, also argued that the costs of continuous electronic monitoring should not be an impediment to saving patients’ lives:

“No matter where you set the thresholds, I think you get too many false negatives and false positives. We either get this sense of security that everything is all right, when in fact it may not be. Or, we have these alarms that are going off that eventually our caregivers get desensitized to.

“I would agree with the notion of continuous monitoring. I don’t see the value of intermittent monitoring. I really stop short at talking about high-risk patients because, while we can define them in a category, we’re going to get burned when we try to differentiate because you don’t always know who’s a high-risk patient.

“One of the questions that’s been asked is, ‘Boy, this is going to cost a lot, isn’t it?’ And I say, ‘Can we not afford to do this?’”

The Physician-Patient Alliance for Health and Safety (PPAHS) applauds the APSF for its goal to prevent every possible death and adverse event associated with opioid induced ventilatory impairment and PCA therapy.

Alarm Fatigue, Patient Monitoring, Patient Safety

PCA Survey Indicates Response to ECRI Institute 2014 Top Ten Safety Technology Hazards and The Joint Commission’s National Patient Safety Goals for 2014

By Lynn Razzano, RN, MSN, ONCC (Clinical Nurse Consultant, Physician-Patient Alliance for Health & Safety) and Michael Wong, JD (Executive Director, Physician-Patient Alliance for Health & Safety)

The ECRI Institute recently released its Top Ten Technology for 2014. At the top of this list – alarm hazards. Although ECRI acknowledges that patient monitors are undoubtedly beneficial, ECRI says that the frequency of alarms can be detrimental:

“Excessive numbers of alarms—particularly alarms for conditions that aren’t clinically significant or that could be prevented from occurring in the first place—can lead to alarm fatigue, and ultimately patient harm. That is:

  • Caregivers can become overwhelmed, unable to respond to all alarms or to distinguish among simultaneously sounding alarms.
  • They can become distracted, with alarms diverting their attention from other important patient care activities.
  • They can become desensitized, possibly missing an important alarm because too many previous alarms proved to be insignificant.”

In the recent survey conducted by A Promise to Amanda Foundation and the Physician-Patient Alliance for Health & Safety, The survey clearly pointed out hospitals views on alarm fatigue as a major clinical concern. Almost 200 hospitals from 40 states confirmed that the issue alarm fatigue was extremely high, with the vast majority (more than 95 percent) concerned.

The decisions clinicians make or are not making as a result of alarm fatigue are potentially detrimental to patient safety and may potentially cause inadequate delivery of care to the patient. The survey also found that almost nine out of ten hospitals (87.8 percent) believe that a reduction of false alarms would increase the use of patient monitoring devices, like an oximeter for oxygenation or capnograph for adequacy of ventilation. This point alone identifies a huge disconnect that jeopardizes patient safety and work flow processes that are essential to safe practices.

Alarm Management and the potential for alarm fatigue has become a national patient safety issue that is preventable and needs to be recognized in order to reduce patient harm and decrease cost expenditures. The results of the PCA Survey suggest two tools that hospitals believe could help manage alarms better.

The first is a single indicator. Seven out of 10 hospitals (70.7 percent) would like “a single indicator that accurately incorporates key vital signs, such as pulse rate, SpO2, respiratory rate, and etCO2.” Moreover, those concerned alarm fatigue is an unmanageable problem were more than twice as likely to want a single-indicator assessment tool (OR=2.278; 95% CI 1.073-4.838). This information helps clinicians reform their practice, re-educate their staff via in-services, develop clinical competencies and hands on communications and observations which would significantly reduce the number of alarms. The adoption and use of the single indicator assessment tool being consistently used by all could promote maximum patient safety. Moreover, from a nursing perspective, such a tool would greatly assist busy staff in quickly evaluating patients.

The second is a recommendation for making patient assessments. Almost half of the respondents (44.6 percent) would like “recommendations on how best to easily make such assessments” of patients, and more than half (52.9 percent) would like to see more clinical training. Moreover, twice as many of those concerned that alarm fatigue is an unmanageable problem would like recommendations for ease of assessment for their nursing staff (OR=2.039; 95% CI 0.992-4.190). Incorporation of such an assessment into the daily care plan could allow for identification of real-time outliers, gaps in care, and the cause of the diversion that resulted in the occurrence of nuisance alarms.

Both of these findings from the survey point to the same issue – how can busy clinicians quickly and easily identify a physiological decline in the patient.

Alarm Fatigue, Capnography, Infographics, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA

INFOGRAPHIC: First National Survey of Patient-Controlled Analgesia Practices

INFOGRAPHIC: First National Survey of Patient-Controlled Analgesia Practices

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Capnography, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

New National Survey Finds Patient Safety at Risk Because of Lack of Consistency in Hospital Patient-Controlled Analgesia Practices

Inconsistency in safe practices most likely accounts for large proportion of adverse events and deaths associated with PCA use, says Physician-Patient Alliance for Health and Safety.

The Physician-Patient Alliance for Health and Safety today released the results from a national survey of United States hospitals on the administration of patient-controlled analgesia (PCA).

According to reports made to the Food and Drug Administration between 2005 and 2009, more than 56,000 adverse events and 700 patient deaths were linked to PCA pumps.

“A national survey of hospitals regarding PCA administration has never been conducted despite PCA pumps being linked to such a high number of adverse events and deaths,” says Michael Wong, JD, founder and executive director of the Physician-Patient Alliance.

“On the negative side, the survey reveals that there is a huge cause for concern for patient safety, as there is a great lack of consistency in safety procedures being followed by hospitals across the country,” says Mr. Wong. “This most likely accounts for a large proportion of adverse events and deaths associated with PCA use.”

Mr. Wong continues: “On the positive side, survey findings also show that adverse events have been averted or costs and expenses reduced by hospitals that are continuously monitoring their patients with pulse oximetry and/or capnography. This demonstrates the critical importance of using continuous monitoring as technological safety nets for patients. As well, it also points to a way hospitals may reduce their costs and expenses.”

A copy of the survey results is available for free on the Physician-Patient Alliance website here.

Capnography, Monitoring Liability and Costs, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

First National Survey of Patient-Controlled Analgesia Hospital Practices Reveals Patient Safety Concerns and Role of Continuous Electronic Monitoring

The Physician-Patient Alliance for Health & Safety (PPAHS) today announced the release of major patient safety findings of the first national survey of patient-controlled analgesia (PCA) practices presented at the recent Society of Anesthesia and Sleep Medicine (SASM) 3rd Annual Conference held October 10-11, 2013.

According to reports made to the Food and Drug Administration between 2005 and 2009, more than 56,000 adverse events and 700 patient deaths were linked to infusion pumps. One out of 378 post-surgical patients were harmed or died from errors related to infusion pumps that help relieve pain after surgical procedures, such as knee or abdominal surgery.

“A national survey of United States hospitals regarding PCA administration has never been conducted,” says Michael Wong, JD, founder and executive director of the Physician-Patient Alliance.

Those involved with the analysis survey and preparation of the survey report were Michael Wong, JD (Executive Director, Physician-Patient Alliance for Health & Safety), Anuj Mabuyi, PhD (Assistant Professor Department of Mathematics, Northeastern Illinois University), and Beverly Gonzalez, ScM (Biostatistician, Johns Hopkins Bloomberg School of Public Health).

On the negative side, the survey shows a huge cause for concern for patient safety, as there is a great lack of consistency in safety procedures being followed by hospitals across the country. “This most likely accounts for a large proportion of adverse events and deaths associated with PCA use,” says Mr. Wong.

On the positive side, survey findings also show that adverse events have been averted and/or costs and expenses reduced by hospitals that are continuously monitoring their patients with pulse oximetry and/or capnography. This demonstrates the critical importance of using continuous monitoring as a technological safety nets for patients. As well, it also points to a way hospitals may reduce their costs and expenses.

“However, when we looked at the type of smart pump being used at the facilities reporting a decline in adverse events or a return on investment, there was a significant correlation with those using smart pumps with integrated end tidal monitoring,” says Mr Wong. “Those using smart pumps with integrated end tidal monitoring were almost three times more likely to have had a reduction in adverse events or a return on investment when measured against costs and expenses (including litigation costs) that might have been incurred.”

For a pdf handout of the poster presentation made at SASM annual conference, please click PPAHS SASM Handout.

Capnography, Patient Monitoring, Patient Safety, Patient-Controlled Analgesics, PCA

Managing Risk with Patient-Controlled Analgesia: Recently Released Safety Checklist Addresses Joint Commission Concerns of Opioid-Related Adverse Events

The Risk Management Quarterly, the peer-reviewed journal for The Association for Healthcare Risk Management of New York, Inc. (the NY chapter of the American Society for Healthcare Risk Management), recently published in its Summer 2013 edition an article by Michael Wong, executive director of the Physician-Patient Alliance for Health & Safety, on managing risk with patient-controlled analgesia (PCA).

Mr. Wong writes:

Use of patient-controlled analgesia to manage patients’ pain is accepted medical practice and is generally considered safe and effective.

Unfortunately, the statistics and the tragic patient stories noted above [please read the article for these patient stories] remind us that without proper protocols and technology in place (such as, using a PCA with integrated capnography), adverse events and patient deaths may occur.

In his recent presentation at a patient safety conference, Dr. Robert Stoelting [president, Anesthesia Patient Safety Foundation] estimated that 13 million patients will use PCA each year. The incidence of opioid-induced respiratory depression ranges from 16% to 5.2%. This means that each year up to 676,000 patients using PCA will experience opioid-induced respiratory depression. This number excludes other forms of opioid administration.

Fortunately, as the experience of St. Joseph/Candler has demonstrated, PCA adverse events can be reduced, if not eliminated, and putting into place proper risk management and patient safety measures can provide a significant return on investment.

Hospitals and healthcare professionals are, therefore, encouraged to use the PCA Safety Checklist as a tool to use to assist with this risk management and reduction.

For a pdf copy of the PCA Safety Checklist referred to in the article, please click here.

To read the article in its entirety, please click Michael Wong article RMQ-Summer 2013.

Capnography, Patient Safety, Patient-Controlled Analgesics, PCA

St. Joseph’s/Candler Hospitals Nominated for Best of Respiratory Care: 8 Years of Event-Free Patient-Controlled Analgesia Monitoring, Improved Patient Safety, and Reduced Healthcare Costs

Physician-Patient Alliance for Health & Safety nominates the respiratory care department of St. Joseph’s/Candler Hospitals in Savannah, Georgia for RT Magazine’s “Best of Care” award.

RT Magazine is looking for nominations for best RT department by July 12, 2013. Please click here.

PPAHS submitted the following nomination and encourages others to also nominate St. Joseph’s/Candler Hospitals:

The respiratory therapy department at St. Joseph’s/Candler Hospitals in Savannah, Georgia, deserves “Best of 2013” for 8 years of event-free use of patient-controlled analgesia (PCA).

St. Joseph’s/Candler Hospitals

in Savannah, Georgia, are two of the oldest continuously operating hospitals in the US. About 10 years ago, SJ/C had three opioid-related events with patient-controlled analgesia (PCA) with serious outcomes over a two-year period.

As was recently described in the RT Magazine article “8 years of Event-Free PCA Monitoring”, these opioid-related adverse events prompted SJC to implement an advanced IV medication safety system. In that interview, Harold Oglesby, RRT, manager of respiratory care at SJ/C, describes how his hospital has had eight years of event-free use of PCA using “smart” PCA pumps with integrated capnography monitoring: “A lot of the information comes from the research that we’ve done that has been focused on PCA patients monitored with capnography and the effectiveness gained in monitoring ventilation versus oxygenation. What we found is that we have an earlier recognition of any patient deterioration using capnography versus using oximetry alone. We also have looked at several case studies of patients, and we noted that by the use of capnography, we’ve recognized deteriorating patients early; so it gives us the leeway to take actions before those patients get into any trouble.”

Moreover, although a human life should never be measures in dollars and cents, St. Joseph’s/Candler Hospitals calculated that their decision made great financial sense:

    • $4 million — estimated potential expenses averted (not including potential litigation costs)
    • $2.5 million — 5-year return on investment

Saving lives and saving money — it sounds exactly what our healthcare system is looking for!

APSF, Capnography, Patient Safety

Adverse Drug Events Discussed at California Hospital Engagement Network

by Sean Power

The Physician-Patient Alliance for Health & Safety recently participated in a webinar hosted through the California Hospital Engagement Network, an organization that brings together hospitals to reduce patient harm by 40% and readmissions by 20% by the end of 2013.

The panel discussion looked at patient stories and best practices for preventing opioid related adverse events. The panelists included:

  • Lenore Alexander, Mothers Against Medical Error;
  • Malinda Loflin, RN, an Oklahoma City medical center
  • Dr. Mark Parmenter, Scripps Health System
  • Debra Fox, Wesley Medical Center, and
  • Michael Wong, Physician-Patient Alliance for Health & Safety.

We’ve summarized the discussion below:

Leah’s Law and Essentials for Safety

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Lenore Alexander shared the story of her daughter, Leah Coufal, who was 11 years old when she died following her successful surgery. Leah underwent surgery to repair a condition called pectus carinatum or ‘pigeon’s chest’, a fairly common condition where the sternum protrudes forward caused by an overgrowth of cartilage.

“Leah was not hooked up to any monitors,” Ms. Alexander recently told Katie Couric on the Katie Couric Show, “Shocking Medical Mistakes”.

Lenore shared Leah’s Four Essentials for Safety as she fights for what she calls Leah’s Law: all patients receiving opioids must be continuously electronically monitored. These four essentials are recommended to be used by caregivers to help make patients and their families to be a partner in patient safety.

1. Ensure patients and families are provided information on proper use of the patient-controlled analgesia (PCA) pump.

Patients need to understand that the patient-controlled analgesia (PCA) device delivers a powerful narcotic. The potency of the drug treating the pain can cause oversedation and it is therefore necessary that families do not administer PCA by proxy.

2. Make sure patients and families understand why they must be monitored for safety reasons.

Oversedation can lead to respiratory depression, which might result in cardiopulmonary arrest that can cause anoxic brain damage or even death.

Pulse oximetry monitors oxygen levels in the blood. Capnography measures ventilation to provide the earliest detection of respiratory depression. Oximetry on the finger and the capnography cannula on the nose provide nurses the opportunity to intervene and prevent respiratory arrest.

3. Save yourself some trouble and educate patients and families about monitor readouts.

Capnography machines display readouts on the device at the patient’s bedside. Make sure patients and families know what a normal capnography waveform looks like and what normal blood oxygen saturation levels fall between. A second set of eyes can prevent adverse events and will engage patients and families in the patient safety process.

4. Educate patients and families why alarms sound and what to do when they do sound.

Educating patients and families about the alarms that help to keep them safe means that they can help nurses identify priority alarms based on condition.

Alarms provide an electronic safety net that supports periodic checks by nurses. Educating patients and families about different alarms can help combat alarm fatigue while increasing the likelihood for a positive patient outcome.

A Nurse’s Perspective on Whether Spot Checks Are Sufficient for Patient Safety

Malinda Loflin, RN, a nurse at an Oklahoma City medical center, shared her expert opinion on intermittent checks for patients on PCA pumps. Ms. Loflin shared the story of her father, Robert Goode, who was nine months away from retirement when he died after a successful surgery with no complications.

Melinda Loflin's father, Robert Goode, who died after a successful surgery with no complications.

Mr. Goode had a history of heart problems and sleep apnea requiring CPAP. Within one day after surgery, Mr. Goode was walking the halls and feeling great. The post-operative orders were for a morphine PCA pump and supplemental oxygen. He was not electronically monitored despite his history of heart problems and sleep apnea.

The deterioration timeline of Mr. Goode.

As Ms. Loflin explained, nursing spot checks met the existing standard of care for Mr. Goode. According to the Lippincott Manual of Nursing Practice, respiratory rate, sedation score, and SpO2 should be checked every hour for twelve hours, then every two hours for twelve hours, then every four hours until the dose is increased or discontinued. In other words, nurses should have checked on Ms. Loflin’s father every 2-4 hours after the first twelve hours.

From Ms. Loflin’s perspective, based on her experience as a nurse and as the daughter of a surgery patient, the prevailing standard of care—2-4 hour nurse checks—are NOT sufficient for ensuring the best patient outcomes.

The Anesthesia Patient Safety Foundation (APSF) and the Institute for Safe Medication Practices (ISMP) agree.

“the conclusions and recommendations of APSF are that intermittent ‘spot checks’ of oxygenation (pulse oximetry) are not adequate for reliably recognizing clinically significant evolving drug-induced respiratory depression in the post-operative period.” -Robert Stoelting, MD, President of the APSF

“One reason why it (periodic spot checks by caregivers and pulse oximetry) is not effective is that a ‘periodic check’ and pulse oximetry would only catch an error, not prevent the error.” -Matthew Grisinger, Director, Error Reporting Programs at the ISMP

Ms. Loflin explains that, from a nurse’s point of view, continuous electronic monitoring with pulse oximetry for oxygenation and capnography for ventilation acts as a nurses’ electronic aid and supplements the 2-4 hour spot checks.

She isn’t the only nurse who holds this perspective, either.

“Human vigilance is required but insufficient, continuous electronic monitoring needs to be there to support and back up nurses, and allow them to visit a patient while monitors are continuously assessing other patients for various physiological parameters (such as, oxygenation with pulse oximeter and adequacy of ventilation with capnography).” -Julianna Morath, RN, MS, Chief Quality and Safety Officer at Vanderbilt University Medical Center

Implementing nursing feedback from individuals like Ms. Loflin and Ms. Morath is integral to achieving better clinical outcomes.

Lessons Learned from Implementing the San Diego Patient Safety Council Toolkit

Mark Parmenter, Pharm.D. (System Director, Clinical Pharmacy Services, Scripps Health System) shared his experience putting into action the San Diego Patient Safety Council Toolkit.

The San Diego Patient Safety Council, who PPAHS readers may remember advocated for continuous monitoring to the CMS proposed quality measure on PCA patient safety, consists of multidisciplinary clinicians and healthcare professionals from acute care facilities across Southern California. It is responsible for offering feedback on best practices, process improvement tools, and obtain consensus on specific topics.

In 2009, Scripps won the Institute for Safe Medication Practices (ISMP) Cheers Award for its PCA toolkit and in 2013 it was the recipient of the AAMI & Becton Dickinson Patient Safety Award.

The San Diego Patient Safety Council offered recommendations for orders, datasets, technology, and monitoring for opioid naïve patients so it created the PCA toolkit which is available for download here.

Impact of Continuous Monitoring

Debra Fox, MBA, RRT-NPS from the Wesley Medical Center in Wichita, KS presented a case study on how continuous electronic monitoring for patients receiving PCA reduced the number and severity of adverse events at the 760-bed facility that handles 150-225 patients per month receiving PCA therapy.

Ms. Fox explained that from 2002 to 2007, Wesley Medical Center increased its emphasis on pain management by using opioid treatments more regularly. They witnessed an increase in opioid related adverse drug events (ADE) during this timeframe. In 2009, the hospital introduced a “smart” pump system that included capnography monitoring.

Wesley also developed policies and procedures to monitor all PCA patients and all high-risk patients receiving IV opioids for the first 48 hours. The goals of the program: effective pain management, fewer severe ADEs, and improved patient safety while receiving PCA.

The hospital observed the percentage of severe ADEs fall from 31% in 2010 before implementing EtCO2 monitoring to 6.8% after implementing it that year. In 2011 and 2012, that percentage continued to drop to 3.6% and 1.4%, respectively.

Wesley Medical Center shares their results after implementing a continuous electronic monitoring program.

Wesley Medical Center won the ISMP Cheers Award in 2012 in recognition for its efforts to improve PCA outcomes.

Recent Recommendations for Reducing Opioid Adverse Events

The Physician-Patient Alliance for Health & Safety discussed a number of recommendations for safe opioid use in hospitals.

The Joint Commission’s Sentinel Event Alert 49 on the safe use of opioids in hospitals states:

“While opioid use is generally safe for most patients, opioid analgesics may be associated with adverse effects, the most serious effect being respiratory depression, which is generally preceded by sedation.”

The Alert cites a study showing that most ADEs were due to drug-drug interactions, most commonly involving opioids, benzodiazepines, or cardiac medications. It cites another study showing that 16% of inpatient adverse drug reactions are attributable to opioids.

The Joint Commission concludes:

“Opioid analgesics rank among the drugs most frequently associated with adverse drug events”

The Physician-Patient Alliance reviewed the causes of opioid-related respiratory depression:

  • Lack of knowledge about potency differences among opioids.
  • Improper prescribing and administration of multiple opioids and modalities of opioid administration (i.e. oral, parenteral, and transdermal patches).
  • Inadequate monitoring of patients on opioids.

The average incidence of opioid-related respiratory depression among patients receiving PCA therapy is around 0.5%. Studies about incidence show that this figure ranges from 0.16% to 5.2%.

Thirteen million patients receive PCA annually, meaning that respiratory depression, using the lower 0.16% figure cited above, occurs in 20,800 patients each year; using the higher 5.2% figure, as many as 676,000 patients experience opioid-induced respiratory depression.

It is estimated that 5,200 potentially preventable episodes of respiratory failure take place in the United States every year. Effective monitoring could reduce this number by half.

To assist hospitals in reducing the number of ADEs for patients on PCA pumps, the Physician-Patient Alliance released a PCA Safety Checklist that is available in Microsoft Word check-able format here and can be downloaded as a PDF here.

What has your hospital done to reduce the number of ADEs in its facilities? Leave a comment below.