Alarm Fatigue, Capnography, Patient Monitoring, Patient Safety, Patient Stories, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring, Postoperative Pain

Perspectives on Opioid Safety and Continuous Electronic Monitoring

by Sean Power
March 11, 2014

In honor of Patient Safety Awareness Week last week, the Premier Safety Institute gathered experts on opioid safety to participate in a webinar discussion. The panel, moderated by Gina Pugliese, RN, MS, vice president, Premier Safety Institute, Premier Inc., featured several authorities on opioid safety, including:

  • Michael Wong, JD, executive director, Physician-Patient Alliance for Health and Safety
  • Harold Oglesby, RRT, manager, The Center for Pulmonary Health, Candler Hospital, St. Joseph’s/Candler Health System
  • Joan Speigel, MD, assistant professor, anesthesiology, Harvard Medical School and Beth Israel Deaconess Medical Center
  • Bhavani S. Kodali, MD, associate professor, Department of Anesthesiology, Brigham and Women’s Hospital, Harvard Medical School.

You can listen to the full recording here, download the slides here, and learn more about opioid safety here.

This article is the first of a two-part series. It summarizes the presentations on opioid safety. The second part will recap the question and answer period with the entire panel.

Will continuous monitoring become a standard of care for patients receiving patient controlled analgesia (PCA)?

The Physician-Patient Alliance for Health and Safety teamed up with A Promise to Amanda Foundation to conduct the first-ever national survey on PCA practice.

“Part of the impetus for the survey was the sheer number of respiratory events that occur each year,” says Mr. Wong.

impetus-for-the-survey

Between 20,000 and 676,000 PCA patients will experience opioid-induced respiratory depression every year.

“However for our purposes, and for A Promise to Amanda, the main impetus is the patients,” Mr. Wong continues.

patients-on-pca

The survey was developed with input from a number of patient safety experts including Richard Dutton, MD, MBA, Executive Director of Anesthesia Quality Institute, and Frank Federico, RPh, Executive Director of the Institute for Healthcare Improvement, Patient Safety Advisory Group, The Joint Commission, among others.

Six patient risk factors have been identified by major health care organizations like The Joint Commission and Institute for Safe Medication Practices (ISMP). These risk factors include:

  • Obesity
  • Low body weight
  • Concomitant medications that potentiate sedative effects of opiate PCA
  • Pre-existing conditions (such as asthma, chronic obstructive pulmonary disease, and sleep apnea)
  • Advanced age
  • Opioid naive

“The survey results show great variability in the risk factors being considered by hospitals across the country,” adds Mr. Wong.

According to the survey results, less than 40 percent of hospitals are considering all six patient risk factors.

Almost one out of five hospitals are not assessing patients for being opioid naïve. Three out of ten hospitals do not consider obesity as a patient risk factor. Three out of 20 hospitals do not consider advanced age.

Approximately 70 percent of PCA adverse events are due to errors associated with pump use, according to the Pennsylvania Patient Safety Authority. Double-checks advocated by ISMP and others can prevent errors from happening.

Patient identification, allergies, drug selection and concentration, dose adjustments, PCA pump settings, and line attachments all need to be double-checked.

“There is a great variation between hospitals performing these very simple six double checks. Sadly, only slightly more than half of all hospitals are performing all six double checks,” says Mr. Wong.

The PCA survey, conducted prior to The Joint Commission’s National Patient Safety Goal on alarm safety, found that 95 percent of hospitals are concerned about alarm fatigue. Almost nine in ten hospitals (87.8 percent) believe that a reduction of false alarms would increase the use of patient monitoring devices like an oximeter or capnograph.

“Hospitals also indicated the value of continuously electronically monitoring their patients receiving opioids,” says Mr. Wong. “All those who reported monitoring said that monitoring reduced adverse events and hospital expenditures, or that it was too early to determine the effect of monitoring.”

Moreover, hospitals using smart pumps with integrated end tidal CO2 (EtCO2) monitoring were almost three times more likely to have had a reduction in adverse events or a return on investment in terms of a reduction in costs and expenses.

The challenge of balancing effective analgesia with safety

Mr. Oglesby was involved in implementing continuous electronic monitoring at St. Joseph’s/Candler Hospitals in Savannah, Georgia, and has spoken about being opioid-related event free for eight years, as well as the return on investment that came with the program.

SJ/C is the largest health care system in southeast Georgia with 675 beds and approximately 25,000 annual discharges. In the two years preceding the implementation of continuous electronic monitoring, SJ/C experienced three opioid-related events with serious outcomes.

“We made sure that we used smart pumps to address the appropriate programming of our pumps. We also wanted to assess what would be the best way of monitoring our patients,” says Mr. Oglesby.

The team that drove the continuous monitoring program was initially comprised of pharmacy and nursing staff. Respiratory therapy was called in to address monitoring options early on in the decision making process.

According to Mr. Oglesby:

“We were specifically asked that question: as respiratory therapists, what did we think would be the earliest indicator of problems with ventilation versus saturation? We quickly said that capnography would be the earliest indicator of ventilatory problems.”

Since the nursing team was new to capnography, and since respiratory therapists were new to pain scales, education was central to the success at SJ/C.

Patient education was equally central.

“We put respiratory therapy in the role of being bedside educators,” says Mr. Oglesby, since respiratory therapists have a good foundational understanding of EtCO2 and its limitations.

“There were times when we would get calls to the bedside from the nursing staff who would say that this patient’s alarm was going off, and going off for no reason,” says Mr. Oglesby. “When you get to the bedside you would go back and review the patient’s trends and look at the waveforms. You would actually see that the patient had good reason for the alarms going off.”

The respiratory therapists found that patients often experienced undiagnosed sleep apnea and that the patients were having moments of apnea.

According to Mr. Oglesby:

“The education at the bedside resulted in the nursing staff becoming really good at using end tidal CO2 to the point that they would take monitors and put them on other patients that weren’t receiving PCA just to do an assessment of those patients.”

Capnography also provided the earliest indication of respiratory depression for patients receiving PCA treatment.

pca-monitoring-trend-data

These screens from an actual patient highlight a few key points about the effectiveness of capnography at providing the earliest indication of respiratory compromise.

“You can see on that monitor that it gives you the time,” explains Mr. Oglesby. “Highlighted on both is 10:00 AM. At 10:00 AM you see the patient’s morphine dose was 2.5 milligrams. The patient’s [oxygen] saturation was 97 percent. Pulse ox was 88. The end tidal CO2 was 43 and the respiratory rate was 20.”

Mr. Oglesby explains that at 10:30 AM, the screens show, EtCO2 rose to 50, which was outside of the established range, and an alarm sounded. The pulse oximeter alarm did not sound until 11:30.

“This was typical,” says Mr. Oglesby. “We were finding that the end tidal CO2 gave us at least that hour window—gave us an hour earlier indication that something was changing with the patient’s status. So if we just had pulse oximetry, we wouldn’t have known until an hour later that something was really going on with that patient.”

According to Mr. Oglesby:

“We truly believe that end tidal CO2 provides us with the earliest indicator of a decline in our patient’s respiratory function.”.

Monitoring patients receiving PCA with capnography at SJ/C resulted in an increased likelihood of better-sustained pain control, faster recovery and discharge, a better patient experience, and eight years of event free usage of PCA therapy.

Alarm Fatigue, Capnography, Patient Monitoring, Patient Safety, Patient Stories, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring, Postoperative Pain

The Intertwined Stories of Amanda Abbiehl and Continuous Electronic Monitoring

In the recent article, “Silent Danger: PCA Pumps and the Case for Continuous Monitoring” published by Association for the Advancement of Medical Instrumentation in Biomedical Instrumentation & Technology, the story of 18-year old Amanda Abbiehl is told as a powerful reminder of the need for continuous electronic monitoring.

Amanda was admitted to hospital for “severe strep throat”, placed on a patient-controlled analgesia pump to manage her pain, and passed away – most likely because of opioid-induced respiratory depression.

In this slide share, this article has been adapted and retold.

The Physician-Patient Alliance for Health and Safety wishes you the best for this holiday season. Our New Year’s Resolution is to do everything we can to eliminate tragedies like Amanda’s. Join us in making a #promise to Amanda to achieve zero preventable deaths associated with opioid-respiratory depression at your hospital.

Alarm Fatigue, Capnography, Patient Monitoring, Patient Safety, Patient Stories, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

3 Questions About Patient Safety and PCA with Brian and Cindy Abbiehl from A Promise to Amanda Foundation

by Sean Power
December 12, 2013

The Physician-Patient Alliance for Health and Safety released their findings from the First National Survey on Patient-Controlled Analgesia (PCA) Safety Practices.

The report on the National Survey on Patient Safety with PCA is available to download for free here. It asked pharmacists, doctors, nurses, respiratory therapists, and administrators at hospitals from 40 states about their safety measures for PCA.

Brian and Cindy Abbiehl, founders of A Promise to Amanda Foundation (which co-sponsored the research), recently shared their thoughts on some of the findings on the patient risk factors being considered at hospitals during the administration of PCA.

The Abbiehls founded A Promise to Amanda Foundation to raise awareness about respiratory depression after the death of their 18 year-old daughter Amanda. Amanda was admitted to a hospital for an infection and was hooked up to a PCA pump to manage her pain. Less than twelve hours after Amanda was put on a PCA using Delaudid she was found unresponsive. Amanda’s parents believe that, had Amanda been monitored with capnography and pulse oximetry, nurses would have been alerted that she was in trouble and been able to intervene.

You can find a copy of the survey results here.

SP: The survey asked respondents about which risk factors they consider before patients initiate PCA. Was there anything in the results that surprised you?

Cindy Abbiehl: I don’t think we had any expectations going into the survey so I wouldn’t say we were surprised by any of the findings.

I think it’s more accurate to say that the results disappointed us in the sense that, for PCA to be administered safely, every risk factor included in the survey should be considered for every patient before initiating PCA. Not all hospitals consider every factor. That needs to change.

The risk factors include obesity, low body weight, concomitant medications that potentiate sedative effects of opiate PCA, pre-existing conditions such as asthma and sleep apnea, advanced age, and opioid naïve.

These risk factors were identified in the Physician-Patient Alliance’s PCA Safety Checklist last year, which was assembled by a number of well-respected health care professionals. The impact of not considering these risk factors can be tragic.

Brian Abbiehl: Cindy and I are talking from experience when we use the word “tragic.” Our daughter, Amanda, was administered PCA to manage pain despite Amanda being opioid naïve. The PCA survey reveals that around 1 in 5 hospitals do not consider whether the patient is opioid naïve before initiating PCA.

Checking if patients are opioid naïve will raise a red flag to health care providers and can prevent tragic outcomes. The Food and Drug Administration associated PCA with 56,000 adverse events and 700 patient deaths between 2005 and 2009. Considering all risk factors can help to prevent these tragic outcomes.

CA: The survey showed that non-pharmacists were about four times less likely than pharmacists to say that they consider opioid naïve as a patient risk factor. As the front line professionals interacting with patients, this reality needs to change. Pharmacists, physicians, nurses, respiratory therapists, and other health care professionals all need to be on the same page when administering PCA.

SP: You two have spoken about Amanda’s death many times in the past. What would you like to see come out of the findings of the survey?

BA: We’re hopeful that the survey will bring attention to the fact that PCA can be dangerous without the proper safety measures in place.

One of the survey’s key findings is that there exists a great lack of consistency in safety procedures being followed by hospitals across the country. Indicated by the survey are a number of safety recommendations for health care providers.

For instance, the survey provides a list of patient risk factors to consider when initiating PCA. It outlines when to perform double-checks, and what to double-check. It highlights the use of capnography, pulse oximetry, and “smart pumps” to keep patients safe. There are a number of other safety practices that can be followed.

CA: When you ask what we’d like to see from the survey, the ultimate answer is better patient outcomes. Safer care. Fewer adverse events. Zero preventable deaths associated with PCA.

Implementing some of the safety practices asked about in the survey, partnered with a culture of safety at hospitals in the United States, will save lives.

SP: Are there any safety practices you believe are particularly important for the administration of PCA?

CA: They’re all critical—especially those contained in the PCA Safety Checklist I mentioned earlier.

A Promise to Amanda Foundation focuses on the continuous electronic monitoring of all patients every time a patient is placed on a PCA pump, is sedated, requires a stay in the PACU following general anesthetic, or requires a stay in the PACU following sedation.

Continuously monitoring with capnography and pulse oximetry is key because it provides a technological safety net. For instance, “smart pumps” with forcing functions monitor trends in the quality of breath. Should these trends indicate that the patient is experiencing respiratory depression, it stops infusing medicine and alerts nurses to intervene.

Without smart pumps, the nurse might not be aware that the patient is experiencing respiratory depression until the nurse’s next “spot check”, which could occur as far as four hours from the time of respiratory depression at some hospitals.

For these reasons, A Promise to Amanda Foundation focuses on making continuous electronic monitoring mandatory in the administration of PCA. It enables health care professionals to prevent adverse events and clinically intervene.

Even if health care professionals miss a double-check, or fail to consider every risk factor, or overlook any other critical safety practice, capnography and pulse oximetry will help to prevent respiratory depression by notifying caregivers before the patient’s condition deteriorates to Code Blue levels.

BA: We understand that alarm fatigue continues to be a main obstacle to implementing the patient monitoring with capnography and pulse oximetry. The survey found that 9 out of 10 hospitals believe reducing false alarms would increase the use of such devices.

In addition to using capnography and pulse oximetry, then, we would insist that reducing the incidence of false alarms is a safety practice that is particularly important for safer PCA use.

The Joint Commission is expected to announce a National Patient Safety Goal on alarm management in 2014. We hope that health care professionals will rally behind them and make PCA safety a priority by improving alarm safety at their hospital.

Capnography, PCA, Post-Operative Monitoring

PPAHS Speaks at A Promise to Amanda Foundation Fundraiser

by Sean Power
August 21, 2013

On behalf of the Physician-Patient Alliance for Health and Safety I would like to congratulate A Promise to Amanda Foundation on a successful fundraiser and awareness campaign.

I would also like to thank Brian and Cindy Abbiehl for inviting PPAHS to speak about the four essentials for safety. The Physician-Patient Alliance hopes that the nearly 400 audience members will share with their doctors and nurses the four essentials for safety while using patient-controlled analgesia pain pumps (PCA):

  1. Ensure patients/families are provided information on proper use of the PCA pump, so they understand
    1. Pump delivers a powerful narcotic
    2. No PCA by proxy
  2. Make sure patients/families understand why they must be monitored for safety reasons:
    1. Oximetry clip on finger
    2. Capnography cannula on nose
  3. Save yourself some trouble and educate patients and families about monitor readouts.
  4. Educate patients why alarms sound and what to do when they do sound.

As promised, I’ve made these slides available on the PPAHS website for download in PDF format here.

The Physician-Patient Alliance is excited by the progress on PCA safety and we hope Amanda’s friends, family, and the South Bend community will join us in making a #promise to Amanda. As Dr. Cheryl Wibbens, Chief Medical Officer at Memorial Hospital in South Bend has stated:

“Monitoring patients for how much carbon dioxide they are breathing out with capnography provides us with the earliest possible indicator to detect the onset of opioid-induced respiratory depression.”

Memorial Hospital joins many hospitals across the country now monitoring with capnography – for some of these hospitals, please view this interactive map.

As Dr. Wibbens further explains:

“Every patient at Memorial that has opioids is a little safer now. Continuously electronically monitoring with capnography will save lives.”

The motto of A Promise to Amanda Foundation is “Capnography saves lives”. Let’s make it a priority at hospitals across the country to save lives.

The lines of communication between healthcare professionals and their patients need to be open for safety to become a priority. These slides can help break the ice for the conversation about patient safety.

Please give these slides to your doctors, nurses, and respiratory therapists and make sure they know that your safety is important. You can play a central role in your own safety. Insist that your healthcare team follows these four essentials the next time you or a loved one are treated with PCA.

To view the local NBC affiliate’s coverage of the event, please click here.

IARS 2013
Capnography, Patient Safety, Patient Stories, Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

PPAHS Presents PCA Safety Checklist at IARS Annual Meeting

by Sean Power

The Physician-Patient Alliance for Health & Safety presented at the International Anesthesia Research Society’s Annual Meeting in San Diego, California to discuss the latest advances in research and best practices in anesthesia clinical care. For a handout version of the poster presentation, please click here.

In its August 2012 Sentinel Event Alert, The Joint Commission warned:

“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 Physician-Patient Alliance recently released a PCA Safety Checklist to assist healthcare professionals prescribe, administer, and monitor patients in need of opioid pain management.

The Problem: Preventable Deaths Caused by Opioid Induced Respiratory Depression Occur Every Year in American Hospitals

According to Frank Overdyk, M.D., M.S., Marieke Niesters, M.D., Ph.D., and Albert Dahan, M.D., Ph.D. at Hofstra University School of Medicine, Hemstead, New York:

“Preventable deaths in hospitals remain a major public health hazard worldwide.”

The research by Dr. Overdyk et. al. shows that unrecognized opioid induced respiratory depression is often a common fatal pathway for “non fatal” conditions. By preventing respiratory depression hospitals can reduce or eliminate the risk of death for patients on opioid pain management plans.

Fifty percent of Code Blue events involve patients receiving opioid analgesia. Unrecognized respiratory failure after surgery that results in cardiopulmonary arrest is a daily occurrence at hospitals in the United States. In the majority of cases these events result in death or anoxic brain injury and have been termed “failure to rescue (FTR)” by Dr. Overdyk.

The Scope of the Problem: Statistics About PCA-Related Adverse Events

It may be helpful to define the scope of the problem posed by opioid analgesia (and in particular patients using PCA pumps) in numeric terms.

  • FTR is the first and third most common cause of patient safety related adverse events and accounts for 113 events per 1,000 at-risk patient admissions, according to an article in Health Grades.
  • More than 56,000 adverse events and 700 patient deaths were linked to PCA pumps in reports to the Food and Drug Administration (FDA) between 2005 and 2009.
  • This information provides context to data collected by Pennsylvania Patient Safety Authority, which revealed that approximately 4,500 adverse events took place in hospitals in the state between 2004 and 2010.
  • The FDA’s Manufacturer and User Device Experience (MAUDE) database demonstrates that PCA-related device events are three times as likely to result in injury or death as reports of device events involving general-purpose infusion pumps.

The Scope of the Problem: Victims of Tragedy

Even more useful in defining the scope of the problem is looking at it in terms of the lives of the victims of inadequate safety measures for patients on PCA pumps.

  • Amanda Abbiehl, 18, died on a general care floor in 2010 after being put on a PCA pump to manage her pain following surgery.
  • Leah Coufal, 11, died after having an epidural anesthesia left in place to manage her postoperative pain.
  • Louise Batz died after being put on a PCA pump to manage her pain after knee surgery.
  • Justin Micalizzi, 11, died after cardiac arrest following surgery.

Part of the Solution: Utilizing a PCA Safety Checklist at Your Hospital

The PCA Safety Checklist was developed in collaboration with patient safety experts across the country. The checklist:

  • Summarizes information about the characteristics of patients at higher risk for over sedation and respiratory depression;
  • Helps to ensure that patients have been appropriately educated about their pain management before using a PCA pump
  • Reminds healthcare providers of potential red flags
  • Makes sure the patient is electronically monitored with both pulse oximetry and capnography, and
  • Provides guidance on assessment and pump settings verification at shift change.

Patient safety experts agree with the direction of the PCA Safety Checklist.

“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.”

-Frank Federico, RPh, Patient Safety Advisory Group at The Joint Commission and executive director at the Institute for Healthcare Improvement

“The Joint Commission recognizes there is an opportunity to improve care for patients by improving the safety of opioid use in acute care settings given that data show opioids are among the top three drugs in which medication-related adverse events are reported. Opioids are necessary to prevent suffering, but there are risks related to potency, route of administration, and patient history. By engaging in a comprehensive approach to assessment, monitoring, and patient education, opioid overuse and associated harm can be prevented.”

-Ana Pujols McKee, MD, executive vice president and chief medical officer at The Joint Commission

The PCA Safety Checklist is available in Microsoft Word check-able format here and can be downloaded as a PDF here.

The PCA Safety Checklist offers a technical solution to technical problems. Hospitals and other healthcare facilities should consider the role of checklists in the context of broader patient safety initiatives.

Has your hospital begun to use the PCA Safety Checklist? Tell us about your experiences with the tool in the comment below.

Patient Safety, Patient-Controlled Analgesics, PCA

Physician-Patient Alliance for Health & Safety Announces Four Essentials for Safety for Patients Receiving Opioids

The Physician-Patient Alliance for Health & Safety (PPAHS), an advocacy group of physicians, nurses, respiratory therapists, healthcare organizations and patient safety advocacy groups, recently released four essentials for patient safety.

These four essentials for patient safety were recently discussed on a webinar on reducing adverse drug events and harm associated with postoperative opioid pain management programs. Premier Safety Institute, an organization dedicated to coordinating safety-related activities among national organizations to help improve safety, hosted the webinar.

The four essentials help improve patient safety by making patients and their families a partner with their healthcare providers:

1. Ensure patients/families are provided information on proper use of the PCA pump, so they understand:

  • Pump delivers a powerful narcotic
  • No PCA by proxy

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

  • oximetry on finger
  • capnography cannula on nose

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

4. Why alarms sound and what to do when they do sound.

Michael Wong, founder and executive director of PPAHS, explains, “Caregivers are encouraged to make patients and their families partners in patient safety. Taking a brief moment to explain these four essentials will improve patient safety.”

As Cindy Abbiehl, who with her husband established A Promise to Amanda Foundation following the tragic death of their 18-year daughter who passed away in 2010 because she was not adequately monitored with EtCO2, said on the webinar

“Basically what we’re looking at is the essentials for safety. Ensure patients and families are provided information on proper use of PCA [patient-controlled analgesia] pumps. A lot of people don’t realize that these pumps do deliver a powerful narcotic. It tends to be an issue if the patient is administering it or if somebody else pushes the button for the patient.”

Proper patient education about the devices with which they manage their pain is therefore essential to safe care. “That’s why we need to make sure that patients and families understand why they must be monitored for safety reasons,” Ms. Abbhiel continues. She explains that oximetry on the finger and a capnography cannula on the nose will prevent adverse drug events for patients using PCA pumps to manage pain.

Educating patients and families about how to interpret monitor readouts helps frontline staff monitor patients. “Brian and I both have discussed how we wished that we could have seen some warning sign. With capnography, it pretty much puts the warning sign on the machine and alerts the nurses without them having to come in.”

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

Memorial Hospital Makes a Promise to Amanda to Continuously Electronically Monitor Opioid Patients with Capnography

NBC-affiliate WNDU recently reported that Memorial Hospital of South Bend in Indiana has fulfilled A Promise to Amanda.  Starting this month, every patient who receives opioids or sedation on every floor at Memorial Hospital will be continuously electronically monitored with capnography.

Maureen McFadden of Abc-affiiliate WNDU discusses why Memorial Hospital is continuously monitoring with capnography

Maureen McFadden of Abc-affiiliate WNDU discusses why Memorial Hospital is continuously monitoring with capnography

Eighteen-year-old Amanda Abbiehl tragically died in 2010 when connected to a patient-controlled analgesia (PCA) pump to manage her pain. Since then, Amanda’s parents, Brian and Cindy, have advocated that patients using PCA pain pumps are monitored with capnography through the Promise to Amanda Foundation, a foundation focused on monitoring CO2. Brian and Cindy have been calling on all hospitals to make a Promise to Amanda by implementing continuous electronic monitoring for every patient on a pain pump.

Capnography provides the earliest possible indicator to detect the onset of opioid-induced respiratory depression.

“Monitoring patients for how much carbon dioxide they are breathing out with capnography provides us with the earliest possible indicator to detect the onset of opioid-induced respiratory depression,” says Dr. Cheryl Wibbens, Chief Medical Officer at Memorial Hospital. “Together with Elkhart General Hospital, Memorial is pleased to provide this level of protection for our patients receiving opioids.”

The Promise to Amanda Foundation applauds Memorial Hospital of South Bend for doing their part in preventing patient deaths associated with pain pumps at its facility. Amanda’s parents, Brian and Cindy Abbiehl, say, “On the day our daughter passed away, we made Amanda a promise that we would help make sure this did not happen to another person. Our daughter passed away and we believe that had she been on a CO2 monitor her caregivers would have been alerted and she may still be with us today. We would like to thank Memorial Hospital for helping to fulfill this promise to Amanda.”

Capnography will save lives.

As Dr. Wibbens further explains, “Every patient at Memorial that has opioids is a little safer now. Continuously electronically monitoring with capnography will save lives.”

The Physician-Patient Alliance for Health & Safety encourages all healthcare professionals to join Memorial Hospital in making a Promise to Amanda to achieve zero preventable deaths.

As Dr. Peter Pronovost (PhD, FCCM, Professor, Departments of Anesthesiology/Critical Care Medicine and Surgery, The Johns Hopkins University School of Medicine and Medical Director, Center for Innovation in Quality Patient) said recently on the Katie Couric Show on “Shocking Medical Mistakes”:

Frame the size of your problem. I suspect that all of your viewers either have been touched by or a family member has been harmed by mistakes. It is the third leading cause of death in this country. More people die from medical mistakes each year than died per year in the civil war.

View the WNDU coverage here.

Capnography, Monitoring Liability and Costs, Patient-Controlled Analgesics, PCA

5 Questions Answered about Never Events and Patient-Controlled Analgesia Pumps

by Sean Power

What are Never Events?

Never Events are 28 preventable actions or mistakes that should never happen in a health care setting, which include:

  • Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration)
  • Intraoperative or immediately post-operative death in an ASA Class I patient (which includes a normal healthy patient)
  • Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended

Wikipedia maintains a list all 28 Never Events.

The National Quality Forum in the United States initially compiled the list. Never Events are quite rare, although the consequences of Never Events can be devastating. How often do Never Events happen?

Some states such as Minnesota have mandatory public reporting laws. Many hospitals are not mandated by their states to report Never Events, though, making it difficult to collect precise numbers. According to The Leapfrog Group, Minnesota has averaged around 100 reported Never Events per year.

Researchers from John Hopkins University School of Medicine in Baltimore conducted the first study to calculate a national rate for Never Events, identifying a total of 9,744 paid malpractice settlement and judgment claims for surgical Never Events between 1990 and 2010.

What is being done to prevent Never Events at health care facilities?

The Centers for Medicare and Medicaid Services (CMS) announced in 2007 that Medicare would no longer pay for additional costs associated with Never Events.

In addition, many hospitals voluntarily publicly report Never Events to increase accountability.

According to Lippincott’s Nursing Center, hospitals that successfully prevent Never Events have established cultures of safety. In other words, hospitals act in the safest manner possible regardless of the degree of regulatory supervision—both management and frontline staff adopt high-reliability behavior such as preoccupation with failure, reluctance to simplify interpretation, and deference to expertise, among other acts.

Which Never Events are associated with Patient-Controlled Analgesia Pumps?

Patient-Controlled Analgesia (PCA) pumps were developed to address under-medication problems for patients requiring pain management. PCA pumps permit the patient to self-administer small doses of narcotics after surgery as a method of pain control.

The risk of respiratory depression can be too great for “opioid naïve” patients—patients who have never experienced prior opioid use—and PCA pumps are now only used for patients who have previously used opioids. Despite these (and other) preventative measures, respiratory depression still occurs too frequently, resulting in serious adverse events and negative patient outcomes.

Of the Never Events listed by the National Quality Forum, PCA pumps might be at risk of contributing to patient death or serious disability associated with a medication error (e.g. incorrectly programming the pump) and with the use or function of a device in patient care in which the device is used or functions other than intended (e.g. a patient’s relative administers medication through the PCA pump on behalf of the patient).

Should dead-in-bed syndrome while on PCA pumps be added to the list of Never Events?

Never Events have two common characteristics: they are totally preventable and they result in serious adverse events. Patient deaths caused by respiratory depression while using PCA pumps share these traits. Therefore, dead-in-bed syndrome needs to be added to the list of Never Events.

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

The PPAHS has also advocated elsewhere on this website that healthcare facilities adopt a PCA safety checklist. Doing so will minimize the likelihood for adverse events to occur.

With continuous end tidal CO2 monitoring of the adequacy of ventilation with capnography and pulse oximetry for oxygenation, nurses are alerted and can intervene before respiratory depression causes serious adverse events. Dead-in-bed syndrome is thus totally preventable and shares the first characteristic of the Never Events list.

Dead-in-bed syndrome can also have devastating or drastic effects, thus sharing the second common trait with the Never Events list. By failing to monitor patients with capnography and pulse oximetry, patients like Amanda Abbiehl and Leah Coufal would not have been found unresponsive and dead-in-bed. These stories prove that respiratory depression can cause serious adverse events with negative patient outcomes, therefore sharing the second characteristic of the Never Events list.

It necessarily follows that dead-in-bed syndrome while on PCA pumps should be added to the list of Never Events, for they share the two key traits that are common to all other Never Events.

Where can I go to learn more about Never Events?

The PPAHS has compiled the following list of resources about Never Events:

AHRQ Patient Safety Network – Never Events

The Agency for Healthcare Research and Quality published a backgrounder on Never Events. People looking for an introduction to the topic will find this AHRQ article helpful.

Preventing Never Events: What Frontline Nurses Need to Know

Lippincott’s Nursing Center explains Never Events and their consequences. The article targets an audience with a nursing background; however, anybody working in the space can benefit from the frontline perspective.

Surgical never events in the United States

The journal Surgery published an article that examines the frequency of Never Events, their costs to the health care system, the outcomes of patients, and the characteristics of providers involved in adverse events. The results of the study may help health care providers create prevention strategies for patients post-op.

What do you think? Should dead in bed syndrome be added to the list of Never Events? Leave your comments below.

Capnography, Patient Stories, Patient-Controlled Analgesics, PCA

Physician-Patient Alliance for Health & Safety (PPAHS) Adds Voice to Physicians and Patient Advocates Warning Patient-Controlled Analgesia (PCA) Pain Pumps Need Better Monitoring

The Physician-Patient Alliance for Health & Safety (PPAHS), an advocacy group devoted to improving patient health and safety, added its voice to a growing number of physicians and patient advocates warning that patient-controlled analgesia (PCA) pain pumps need to be continuously electronically monitored with oximetry for oxygenation and capnography for adequacy of ventilation.

In a recent article, Everyday Health reports on one case involving a pain pump was that of 18-year old Amanda Abbiehl of Granger, Ind., who was looking forward to high school graduation when she came down with a throat infection so severe it landed her in the hospital. Her parents were relieved when a patient-controlled analgesia (PCA) pain pump delivering powerful opioids finally seemed to relieve their daughter’s blistering throat pain.

18-year old Amanda Abbiehl recently died in a PCA-related incident

The Everyday Health article interviewed Amanda’s parents, Brian and Cindy Abbiehl:

“She was feeling much, much better…” says Cindy Abbiehl. “So I kissed her goodnight, told her we loved her…”

Recounting the night in July 2010, Cindy breaks down sobbing. It was the last time she would see Amanda alive. A coroner’s report found the “probable cause of death” was a viral infection, and due to a legal settlement, Brian and Cindy Abbiehl cannot discuss specific details of Amanda’s medical treatment. But the Abbiehls believe the pain pump may have played a role in her death. In her honor, they have set up a foundation (promisetoamanda.org) to educate health care professionals and patients about the potential risks of PCA pumps, and to provide safety checklists for those using pain pumps.

Michael Wong, executive director of the PPAHS, says, “Continuous electronic monitoring with oximetry for oxygenation and capnography for the adequacy of ventilation that the Promise to Amanda Foundation is creating awareness of provides a much needed technological safety net for patients. Had Amanda been monitored with capnography, perhaps her caregivers would have been alerted in time and she would still be alive today.”

Patient controlled analgesia (PCA) pain pumps are commonly used medical devices that allow patients to self-administer pain medication with the push of a button. “PCA is an effective way and a desirable way to give patients pain medicine,” says Frank J. Overdyk, MD, an anesthesiologist at North Shore University Hospital. “Yet it needs some safety mechanisms.”

According to the FDA, between 2005 and 2009, more than 500 patient deaths and 56,000 adverse events have been linked to PCA pain pumps.

Dr. Overdyk, who has been an expert in a number of legal cases involving PCA pain pumps, advocates for continuous electronic monitoring of pain pumps through technologies such as capnography, which monitors CO2 levels and alerts medical staff when there is a potential problem. As. Dr. Overdyk explains, one of the reasons why this  issue “has not come to the forefront more is because it is difficult to pinpoint the opioid affect.”

Says Dr. Overdyk, “Patients are typically told don’t worry you can hit the buttons as many times as you like. Unfortunately, it is not as simple as that.”

The PPAHS recently released a safety 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.

This safety checklist targeting PCA can be viewed and downloaded for free at www.ppahs.org

Capnography, Patient Safety, Patient-Controlled Analgesics, PCA

The Path to a Safer PCA Pump: Improving Patient Safety with Integrated Capnography

By Timothy L.V. Wong (college intern with A Promise to Amanda Foundation, a non-profit working to ensure – “Monitor ALL PCA patients using Capnography – It Saves Lives”)

Patient Controlled Analgesia is the most common and effective form of pain treatment because it offers consistent and continuous pain relief. However, faults in current PCA technology are putting patients at risk everyday.

Before the 1960’s, personal pain control consisted of large doses of medication. These were administered bedside by nurses on a regular, but not frequent schedule or on demand if one felt pain. Dr. Benson B. Roe was the first to discover that smaller and more regular doses treated pain more effectively.

In the late 1960’s, Dr. Phillip H. Sechzer began to develop machines that could take the place of bedside nurses to provide pain relief through an IV anytime a patient experienced pain.  This new technology was called Patient Controlled Analgesia or PCA. In 1976, the first PCA pump, Cardiff Palliator, was released and used commercially.

The “Smart” Pump was introduced next – a PCA pump that can be programmed by a healthcare professional. This mechanic limits the dose delivered each time the patient requires it and is meant to reduce the risk of overdose. Yet, there are fatal errors that still occur with “smart” pumps.

The tragic story of Amanda Abbiehl is a powerful example of the dangers of PCA use. On July 15, 2010, Amanda, an 18 year old girl, was admitted to a local hospital for treatment of a virus that was causing mouth and throat pain. She was placed on a PCA pump to allow her to control when the pain medication was administered. The next morning Amanda was found unresponsive and died.

The most recent PCA pump in its evolution allows safer use through the use of Capnography and Pulse Oximetry. Capnography is a device that monitors a patient’s CO2 output. Unlike its predecessor, a drop in the adequacy of ventilation immediately shuts off the PCA pump and an alarm is also sounded to alert nearby nurses of the patient’s declining health. This “forcing function” does not allow the prescribed sedative to be administered until the patient has been assessed by a healthcare professional.

As Bryanne Patail, biomedical engineer at the U.S. Department of Veterans Affairs (VHA), National Center for Patient Safety explains:

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.

The VHA says using PCA pumps with integrated capnography “could prevent more than 60 percent of adverse events related to PCA pumps”.

If adverse events and deaths still occur with “smart” pumps, like that of Amanda, how smart is the “smart” pump really?

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