Patient Monitoring, Patient Safety

Top 10 Opioid Safety Articles in 2014

Of the more than 125 articles we posted in 2014, below are 10 of the most read and most discussed articles on opioid safety (order is by publication date).

As you read through these articles, please ask yourself – has a new standard of care been established requiring continuous electronic monitoring by hospitals of all patients receiving opioids?

  1. PPAHS Joins Anesthesia Patient Safety Foundation in Call for a “Paradigm Shift” in Opioid Safety (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.”To view the APSF video, please click on the image below:APSF Video
  2. Opioid Safety Experts Say Continuous Monitoring of Post-Surgical Patients Receiving Opioids Should Be Universal Standard (May 14, 2014)

Continuous electronic monitoring of patients receiving opioids to manage their pain after surgery should be a universal standard of care, leading opioid safety experts said during a recent webinar hosted by Premier Safety Institute as part of their Advisor Live series.

“There is no doubt that patients who have either sedation or postoperative pain management do require some sort of monitoring,” said Bhavani S. Kodali, MD, Associate Professor, Department of Anesthesiology, Brigham and Women’s Hospital, Harvard Medical School.

  1. Identifying Patients at Risk for Postsurgical Opioid-Related Adverse Events (June 3, 2014)

What if there existed a way for perioperative nurses to identify patients at high risk of experiencing opioid-related adverse events?

This was the question and research answer that Laura Menditto, MPH, MBA (Independent Health Outcomes Research Consultant, Laura A Menditto LLC ) and her colleagues presented at the annual conference of Association of periOperative Registered Nurses (AORN).

  1. What Does New CMS Guidance on Monitoring Post-Operative Patients Receiving Opioids Mean for Hospital Practice? (July 15, 2014)

New guidance from the Centers for Medicare & Medicaid Services (CMS) recommends “monitoring of patients receiving opioids … [this is] a signal that CMS is perhaps moving towards a future quality measure calling for continuous electronic monitoring of patients receiving opioids. If so, because of the time, expense, and training involved in implementing technology, hospitals should take heed and prepare themselves for being so measured.”

  1. “Keep It On” Campaign: 8 Tips for Ensuring Children are Monitored Safely (September 25, 2014)

Although Lynn Razzano, clinical nurse consultant, wrote this article in memory of a one-year old boy who suffered from leukemia, there are lessons for caring for all patients – not just children – in the “Keep It On” Campaign.

  1. Monitoring for Respiratory Compromise to Detect Cardiac Arrest (October 7, 2014)

In his op-ed, Lakshmipathi Chelluri, MD, MPH (Professor, Department of Critical Care Medicine, Co-chair, P&T Committee, UPMC Presbyterian, University of Pittsburgh School of Medicine), asks a great question “Preventable In-Hospital Cardiac Arrests―Are We Monitoring the Wrong Organ?”

To help prevent the onset of cardiac arrest, Dr. Chelluri suggests that clinicians should be monitoring for respiratory compromise as a key trigger or potential alert for cardiac arrest.

  1. Sleep Apnea + Opiods = Post-Surgical Preventable Death (October 14, 2014)

Patricia LaChance, whose husband died after routine shoulder surgery, poignantly discusses this frightful formula – Sleep Apnea + Opiods = Post-Surgical Preventable Death

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

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

Kenneth P. Rothfield, M.D., M.B.A. echoes the dangers of risk stratification of patients with sleep apnea (which Patricia’s husband was) in his article, “Risk Stratification of Sleep Apnea Patients – A Recipe for Death?

And, for another story of medical error, Annette Smith looks for answers about her father’s death – “Medical Error Takes a Father’s Life: A Daughter’s Plea for Answers”.

  1. A Decade of Excellence: Hospital Celebrates 10 “Event Free” Years of Patient Safety (October 14, 2014)

In a testament to the efficacy of monitoring patients receiving opioids, St. Joseph’s/Candler Hospital celebrated 10 “event free” years of patient safety.

Thank you to Harold Oglesby (Registered Respiratory Therapist (RRT), Manager, The Center for Pulmonary Health, Candler Hospital, and St. Joseph’s/Candler Health System), who is on our advisory board, and his team for this incredible achievement!

  1. Medical standards of care and the Joan Rivers death (November 7, 2014)

When medical tragedies occur, such as the death of Joan Rivers, one of the very first questions asked by patients, families, the legal system, the press, and the public is: “were appropriate care standards met?”

Joan Rivers - she made us laugh

Joan Rivers – she made us laugh

This article by Michael Wong, JD (Executive Director, Physician-Patient Alliance for Health & Safety), Frank Overdyk, MSEE, MD  (Professor of Anesthesiology, Hofstra North Shore-LIJ School of Medicine), Lynn Razzano, RN, MSN, ONCC (Clinical Nurse Consultant, Physician-Patient Alliance for Health & Safety), Kenneth P. Rothfield, MD, MBA (System Chief Medical Officer, St. Vincent’s Healthcare) looks the different standards of medical organizations for monitoring patients receiving opioids.

  1. Patient Stories Shared at First Meeting of National Coalition to Promote Continuous Monitoring of Patients on Opioids (November 26, 2014)

Was a new standard of care set at the first meeting of the National Coalition to Promote Continuous Monitoring of Patients on Opioids?

This meeting was convened by 17 leading national healthcare organizations and patient safety advocacies including The Joint Commission, which accredits and certifies more than 20,500 health care organizations and programs in the United States, and attended by more than 50 key health organizations.

Alarm Fatigue, Patient Monitoring, Weekly Must Reads in Patient Safety

Weekly Must Reads in Patient Safety (Oct 17, 2014)

Monitoring is the catch word for this week’s must reads. It keeps patients safe and prevents avoidable patient harm. While St Joseph/Candler Hospital just celebrated 10 years of being “event free”, each year an estimated 20,800 to 678,000 patients managing their pain with patient-controlled analgesia will experience life-threatening, opioid-induced respiratory depression. If you are scared about asking your caregivers about monitoring, just say Dr. Robert Stoelting (President, Anesthesia Patient Safety Foundation) told you to.

But, in monitoring, be mindful of alarm alerts and alarm fatigue. We offer advice from members of our advisory board.

Monitor to Stay Safe

St. Joseph/Candler just celebrated 10 years of being “event free”. Starting with capnography monitoring for patients using patient-controlled analgesia, “monitoring technology is now utilized for both non-intubated and intubated patients, in the ICU, on the general floor wherever patients are receiving opioids, in the emergency room and for patients who are having procedural sedation”, says Harold Oglesby, Registered Respiratory Therapist (RRT), Manager, The Center for Pulmonary Health, Candler Hospital, and St. Joseph’s/Candler Health System.

All hospitals should follow the best practice example of St. Joseph’s/Candler.

So, the next time you are going to receive a sedative, opioid or analgesic, just say Dr. Stoelting told you to ask about monitoring in your pre-procedure discussion with your physician before receiving the dose.

Dr. Robert Stoelting (President, Anesthesia Patient Safety Foundation) says that patients about to go undergo endoscopies or colonoscopies might consider asking three questions:

  • How will I be monitored?
  • Who will be responsible for my monitoring, and will that person have other responsibilities?
  • What are the qualifications/training for the person responsible for my monitoring?

Helping Hospitals Fight The Battle Against Alarm Fatigue

However, monitoring may result in alarm fatigue. Hats off to @BN3WS, @rohitnnayak, @thebigbusman, @androworldnews and many others for tweeting about this.

According to Robert J. Szczerba at Forbes, “One of the top technologies hazards in the healthcare system is the problem of alarm fatigue, in which the sheer number, variety, and frequency of machine alarms in a hospital room leads to many of them being ignored or muted. The negative results range from annoyance to patient deaths.”

To help reduce alarm fatigue, we offer advice from members of our advisory board:

Capnography, Patient Monitoring

Open Letter for Patient Safety and Use of Continuous Electronic Monitoring

In the story, “Hypoxia After Surgery Much More Common Than Previously Believed — Study finds high rate of prolonged bouts of desaturation on wards” (Anesthesiology News, March), Daniel Sessler, MD (Michael Cudahy Professor & Chair, Department of Outcomes Research, The Cleveland Clinic; Director, Outcomes Research Consortium) who helped conduct the study, described its results as “sobering.”

This research found that a large fraction of patients experiences prolonged periods of hypoxemia while recovering from surgery – approximately 21 percent of patients averaged at least 10 minutes per hour with SpO2 values below 90 percent, approximately 8 percent of patients averaged at least 20 minutes per hour, and approximately 8 percent of patients averaged at least 5 minutes per hour with SpO2 less than 85 percent. As Dr. Sessler noted, most health experts agree that long periods of oxygen desaturation are not good for patients. Dr. Sessler also pointed out that physicians need an early warning sign for respiratory distress, which is currently only possible through continuous electronic monitoring.

We couldn’t agree more with his description. A recent research report from HealthGrades confirms the seriousness of these findings. HealthGrades examined nearly 288,000 life-threatening events that occurred among Medicare patients in U.S. hospitals from 2009 through 2011. According to HealthGrades, three patient safety-indicators accounted for two-thirds (66.7 percent) of these adverse events: respiratory failure after surgery; deep blood clots in the lungs or legs following surgery; and accidental punctures or lacerations during a procedure. A more relevant fact was that respiratory failure represented 60,632 (22 percent) of the 287,630 adverse events listed in the HealthGrades report.

Dr. Sessler states that because hypoxia is so common, he believes continuous pulse oximetry will become a standard of care in the next five to 10 years. However, five to 10 years is too long to wait, according to the Anesthesia Patient Safety Foundation (APSF).

Referring to a recent released video by the APSF, Robert Steolting, MD (President, APSF) believes that there must be a paradigm shift in the way that we monitor receiving opioids. As he says:

“It’s time for a change in how we monitor postoperative patients receiving opioids. We need a complete paradigm shift in how we approach safer care for postoperative patients receiving opioids.”

Continuous electronic monitoring of all patients receiving opioids with pulse oximetry for oxygenation and capnography for adequacy of ventilation, as recommended by the APSF, would be the “alert” that we need to intervene in a timely manner for better patient safety and outcomes.

Although we fervently concur that continuous electronic monitoring needs to be a national patient-safety standard, we sincerely hope this occurs far sooner than Dr. Sessler predicts. Why? Because patients’ lives are literally at stake. We can’t afford to wait any longer. Having lost our otherwise healthy loved ones — Amanda, John, and Leah — to undetected respiratory depression, we know this all too well.

Sincerely,

Cindy and Brian Abbieh (Founders, A Promise to Amanda Foundation)

Patricia LaChance (Wife of John Michael LaChance)

Lenore Alexander (Founder & Executive Director, LeahsLegacy)

Michael Wong, JD (Founder & Executive Director, Physician-Patient Alliance for Health & Safety) – for all patients – and their families – who have suffered an adverse event or death due to undetected respiratory depression

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.

Capnography, Patient Stories, PCA, Post-Operative Monitoring

Woman’s Death After Knee Surgery Calls Attention to Need for Better Monitoring

by Sean Power

The recent death of Helen Bousquet after what is being described by her son, Brian Evans, as “a basic routine procedure” at a hospital 40 minutes north of Boston highlights the need for better monitoring of patients after surgery. Mr. Evans is accusing the hospital of criminal negligence, according to an exclusive interview with Valley Patriot, as a result of how his mother’s visit to the hospital was handled by staff.

I spoke with Michael Wong, Executive Director here at the Physician-Patient Alliance for Health & Safety. He offered comments on the interview.

“Although the hospital never did an autopsy, Helen Bousquet’s sleep apnea has been listed as one of the causes of death on her death certificate,” says Mr. Wong. “Brian Evans’ interview with Valley Patriot makes it clear that his mother was on morphine and that her breathing was not continuously monitored. This combination is disastrous.”

Warned By Hospital Accreditation Body The Joint Commission

In August 2012, The Joint Commission, the regulatory body that oversees hospital accreditation, issued a Sentinel Event Alert regarding the safe use of opioids like morphine in hospitals.

“Sleep apnea is the very first characteristic of patients who are at higher risk for oversedation and respiratory depression listed in The Joint Commission’s Sentinel Event Alert,” says Mr. Wong. “The Alert’s list also includes patients who are post-surgery and patients with preexisting pulmonary or cardiac disease. Mr. Evans has stated his mother had a heart condition and just had knee surgery. There is no way Ms. Bousquet should have received morphine pain management without adequate monitoring.”

The PPAHS has had patient safety experts comment on PCA safety in the past. While we haven’t reached out for comment on this specific case, I found some pieces of insight that might be applicable.

Frank Overdyk, MD, Professor of Anesthesiology at Hofstra North Shore-LIJ School of Medicine, in an earlier discussion about The Joint Commission’s list of high-risk characteristics:

“To be honest, I look at this list, I can’t remember a patient in recent history who did not have one or more of these conditions.”

Robert Stoelting, MD, president of the Anesthesia Patient Safety Foundation (APSF), in earlier comments on preventing opioid-induced respiratory depression:

“APSF recommends that monitoring be continuous and not intermittent, and that continuous electronic monitoring with both pulse oximetry for oxygenation and capnography for the adequacy of ventilation be considered for all patients.”

Dr. Peter Pronovost, PhD, FCCM (Professor, Departments of Anesthesiology/Critical Care Medicine and Surgery, The Johns Hopkins University School of Medicine and Medical Director, Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality) , has previously explained:

“We have a healthcare system that relies on the heroism of our clinicians rather than designing safe systems. There is technology right now that can monitor someone.”

Peter Corsale, a lawyer with Gallop, Johnson, & Neuman, L.C., in St. Louis, Missouri, on the liability implications of the availability of technology that monitors breathing:

“Simply put, capnography is now becoming standard practice outside of the tertiary care setting.”

As I mentioned, I haven’t asked any of these experts to comment on this specific case. But it is easy to see how following these recommendations might have prevented respiratory arrest in Ms. Bousquet’s death.

Mr. Wong concludes:

“Ms. Bousquet’s death from inadequate monitoring after a routine procedure is not the first. 18 year-old Amanda Abbiehl died after being admitted to a hospital for strep throat. 11 year-old Leah Coufal died after elective surgery. 11 Year-old Justin Micalizzi died after seeing doctors about a swollen ankle. Louis Batz, a mother and grandmother herself, died from a lack of monitoring after her own knee surgery. Helen Bousquet tragically joins these other victims of inadequate monitoring.”

The Physician-Patient Alliance for Health & Safety recently released a concise checklist that reminds caregivers of the essential steps needed to be taken to initiate Patient-Controlled Analgesia (PCA) with a patient and to continue to assess that patient’s use of PCA. It is available in Microsoft Word check-able format here and can be downloaded as a PDF here.

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.

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

Reducing Errors by More than 60 Percent: PPAHS Presents at the Northern Regional Respiratory Care Conference

by Sean Power

Last week, the Physician-Patient Alliance for Health & Safety presented two cases in which health care facilities reduced PCA-related adverse drug events with continuous electronic monitoring.

Experts estimate that anywhere from 600,000 to 2,000,000 PCA errors occur each year. As Dr. Richard Dutton, Executive Director of the Anesthesia Quality Institute, states, “PCA errors certainly occur, both in programming and in delivery, but any published estimate is likely to be only the tip of the iceberg.”

PCA errors certainly occur, both in programming and in delivery, but any published estimate is likely to be only the tip of the iceberg.” Dr Richard Dutton Executive Director Anesthesia Quality Institute

PCA errors certainly occur, both in programming and in delivery, but any published estimate is likely to be only the tip of the iceberg.”
Dr Richard Dutton
Executive Director
Anesthesia Quality Institute

Two hospital systems have implemented solutions to reduce the number of PCA errors.

The Veterans Health Affairs Solution: Implement Strong Fixes

The Physician-Patient Alliance discussed an interview conducting by our executive director Michael Wong with Bryanne Patail, Biomedical Engineer with the U.S. Department of Veterans Affairs, National Center for Patient Safety.

In that interview, Mr. Patail explained how fixing processes leads to better patient outcomes: “In looking at fixes, they can be categorized as strong, intermediate, or weak fixes. The strongest fix for PCA pumps is a forcing function, such as an integrated end tidal CO2 monitor that will pause the pump if a possible over infusion occurred. So, healthcare providers should first look at these strong fixes. There they will see the most impact on reducing errors and improving patient safety.”

Mr. Patail estimates that using capnography, which measures in real-time the adequacy of ventilation, could prevent more than 60 percent of adverse events related to PCA pumps.

The St. Joseph’s/Candler Hospitals Story: Entering Their 8th “Event Free” Year

The Physician-Patient Alliance also discussed how St. Joseph/Candler has been opioid adverse event free for more than 8 years.

St. Joseph’s/Candler’s Hospitals is the largest healthcare system in southeast Georgia with 675 beds and approximately 25,000 annual discharges. In less than a two-year period, they witnessed three significant adverse drug events. To address the problem, in 2002, SJCHS began to replace its existing traditional IV pumps with “smart” IV safety systems—PCA pumps with integrated capnography.

SJCHS estimates that at least 471 adverse drug events have been prevented in eight years since implementing capnography. Equally impressive, the hospital estimates it has prevented $4 million in expenses, not including potential litigation costs. This money can go toward other areas of patient care.

After five years, SJCHS saw $2.5 million return on investment. As Ray Maddox and Carolyn Williams reminds audiences in their paper, “Clinical Experience with Capnography Monitoring for PCA Patients” (APSF Newsletter Winter 2012), there can never exist an adequate monetary valuation of a life saved from preventing an adverse drug event.

Preventing PCA Errors at Your Hospital

The Physician-Patient Alliance, in collaboration with clinical professionals, developed a PCA Safety Checklist that reminds caregivers of the essential steps to take to initiate and assess the use of PCA pumps. While the PCA Safety Checklist is not a comprehensive guideline, the document summarizes evidence-based research that helps decision makers reach solutions.

The PCA Safety Checklist has received some praise by healthcare professionals:

Frank Federico, RPh (Patient Safety Advisory Group at The Joint Commission and Executive Director at the Institute for Healthcare Improvement):

Use and adherence with standardized processes for eligible patients leads to better clinical outcomes. The PPAHS PCA checklist lays out essential steps to be taken to initiate patient-controlled analgesia (PCA) with a patient and to continue to assess that patient’s use of PCA. Following these steps will help to increase patient safety and save lives.

“A checklist would help avoid many things that could go wrong with PCA.” –Dr. Elliot Krane, Director, Pediatric Pain Management, Lucile Packard Children’s Hospital at Stanford.

“A checklist would help to avoid simple but recurrent errors in packaging and programming the PCA.” –Dr. Richard Dutton, Executive Director, Anesthesia Quality Institute.

“In practice, checklists serve as a mental reminder of critical steps that we may or may not remember. Therefore, the value of a checklist with regards to PCAs would be to remind us/double check a critical step in the process.” –Dr. Julius Cuong Pham, Department of Emergency Medicine, Department of Anesthesia and Critical Care Medicine, Armstrong Institute for Patient Safety and Quality at Johns Hopkins University School of Medicine.

“The use of a well-constructed checklist that ensures proper procedures are followed in patient-controlled analgesia would enhance patient safety.” –Dr. Andrew Kofke, Co-Director Hospital of the University of Pennsylvania Neurocritical Care Program.

You can download the free pdf version of PCA Safety Checklist here or a “checkable” and changeable word version of the PCA Safety Checklist by going to the top right hand corner of our website http://www.ppahs.org

Capnography, Post-Operative Monitoring

US Representative Keith Ellison Calls for Elimination of Preventable Deaths and Continuous Electronic Monitoring of All Post-Operative Patients Receiving Opioids

US Representative Keith Ellison (D-MN), Co-Chair of the Congressional Progressive Caucus and Chief Deputy Whip, recently urged the US House of Representatives to work to prevent patient deaths. To view the CSPAN video, please click here.

Rep. Keith Ellison Calls for Continuous Monitoring

98,000 people died from preventable deaths in 1998.

“In 1998, statistics show that about 98,000 people a year died from preventable deaths”, says Mr. Ellison.

Unfortunately, the number of preventable patient deaths has gone up since that time. Explains Mr. Ellison, “That number has grown. We are now at about 200,000 people a year who die in hospitals because of preventable death. That’s about 3,800 people every week. Basically, about two jumbo passenger airplanes crashing and killing all of the passengers.”

Mr. Ellison calls for coordination, saying that “it is possible to eliminate these deaths. It is possible through a series of measures to even eliminate them completely.”

In making this call, he cites the case of 11-year old Leah Coufal. Following 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 in considerable pain and her doses of fentanyl were repeatedly increased to the point that it took three adults to hold her up. Tragically, Leah was not hooked up to any monitors following her successful surgery, and she was found by her mother in the early hours of the morning dead in her hospital bed.

Continuous electronic monitoring would have saved Leah.

To help eliminate preventable deaths, Mr. Ellison calls for continuous electronic monitoring of post-operative patients receiving opioids. As Mr. Ellison concludes, if Leah ”had been monitored continuously after surgery, hospital staff would have been alerted and Leah probably would have been rescued.”

As recently stated by Robert Stoelting, MD, president of the Anesthesia Patient Safety Foundation (APSF), to prevent opioid-induced respiratory depression, “APSF recommends that monitoring be continuous and not intermittent, and that continuous electronic monitoring with both pulse oximetry for oxygenation and capnography for the adequacy of ventilation be considered for all patients.”

Eliminating preventable deaths is “something that we as a nation need to step forward and do something about,” says Mr. Ellison.

The Physician-Patient Alliance for Health & Safety applauds Mr. Ellison’s call for coordination to eliminate preventable deaths and continuous electronic monitoring of all post-operative patients receiving opioids.

Alarm Fatigue, Patient Safety, Post-Operative Monitoring

Recent Death of 17-Year Old From Unmonitored Tonsillectomy Should Never Have Happened

In Willow Grove, PA, 17-year old Mariah Edwards went into a surgical center to remove her tonsils and died.

ABC News recently reported that the outpatient tonsillectomy was a success. Following the procedure she was moved to a recovery room. In the lawsuit filed on behalf of the Edwards family, it provides that nurses administered a dose of the painkiller fentanyl, a potent, synthetic narcotic analgesic with a rapid onset and short duration of action.

The Edwards’ attorney, Joel Feller of Ross Feller Casey, LLP, a medical malpractice firm in Philadelphia, says that the narcotic threw Mariah into opioid-induced respiratory depression. However, the nurse who was supposed to be watching the teenager was busy tending to another patient.

Moreover, in discovery, a nurse for the surgical center admitted that the monitors attached to Mariah had been muted for sound.

“Tragedies like this should never happen,” says Michael Wong, founder and executive director of the Physician-Patient Alliance for Health & Safety (PPAHS), an advocacy group that is pushing for higher standards of care for patients receiving opioids. “A young girl died from a common procedure that hundreds of patients undergo every year because her caregivers choose to ignore the very monitors that were there to protect her life.”

According to ECRI Institute, an independent, nonprofit organization that researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care, alarm hazards are again the number one health technology hazard for 2013. In its report, “2013 Top 10 Health Technology Hazards”, ECRI stated:

Many medical devices in the hospital, such as physiologic monitors (including telemetry monitors), ventilators, infusion pumps, and dialysis units, rely on alarms to help protect patients. But the alarm systems on these devices can also be the source of problems, and there are times when alarms actually contribute to the occurrence of adverse events.

Dr. Robert Stoelting (President, Anesthesia Patient Safety Foundation) explains the impact of false alarms on patient care, “APSF recommends that continuous electronic monitoring of oxygenation and ventilation be available and considered for all patients. This would reduce the likelihood of unrecognized clinically significant opioid-induced depression of ventilation in the postoperative period. However, continuous electronic monitoring may result in threshold-based alarms sounding frequently and the unfortunate consequence that the caregiver fails to recognize early signs of progressive hypoventilation by either being too sensitive (excess false alarms) or insufficiently sensitive.”

Reducing alarm fatigue and making alarms more actionable is a critical patient safety issue. Mr. Wong encourages the adoption of best practices, “There are hospitals that have been able to successfully address alarm fatigue, which might prevent what tragically happened to 17-year old Mariah Edwards. A recent study at The Johns Hopkins Hospital, for example, was able to reduce the number of alarms that sounded by 43 percent.”

Patient Safety, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

Preventing “Dead In Bed Syndrome” with Patients After Surgery

by Michael Wong

In our recently conducted survey among healthcare providers, almost all the respondents (85%) favor the development and use of safety checklists.

Because of this strong desire of healthcare professionals to have a checklist, PPAHS is putting together a working group to create a checklist targeted towards patient-controlled analgesia. This checklist would reinforce the need for continuous electronic monitoring for oxygenation and ventilation. For studies and Anesthesia Patient Safety Foundation recommendations on patient-controlled analgesia, please click here.

“We should stop the found dead in bed syndrome,” says Dr. Andrew Kofke (Co-Director at Hospital of the University of Pennsylvania Neurocritical Care Program). “The use of a well-constructed checklist that ensures proper procedures are followed in patient-controlled analgesia would enhance patient safety.”

An example of a checklist is the surgical checklist that was created and is being promoted by the World Health Organization and through the efforts of Dr. Atul Gawande (Associate Professor of Surgery at Harvard Medical School and General and Endocrine Surgeon at Brigham and Women’s Hospital).

“Avoidable failures are common and persistent, not to mention demoralizing and frustrating,” Dr. Gawande says. “And the reason is increasingly evident: the volume and complexity of what we know has exceeded our individual ability to deliver its benefits correct, safely, or reliably.”

“A checklist would help ensure that necessary procedures are followed when a patient is provided with a PCA pump,” explains Dr. Elliot Krane (Director, Pediatric Pain Management at Lucile Packard Children’s Hospital at Stanford).

“When there is a handoff of a patient from team to team, or location to location (such as OR to PACU, OR to ICU, ICU to OR, etc.), I have been impressed that there are times in which things fall through the cracks, from relatively minor things like missed doses of antibiotics, to critical things like ventilators not being properly connected, potentially resulting in hypoxia,” says Dr. Krane.

Do you think that a succinct checklist (5 or 6 key items) targeted at patient-controlled analgesia would enhance patient safety?

If you may be interested in assisting to develop such a checklist, please email PPAHS at mike.ppahs@gmail.com