Patient Monitoring, Patient Safety

Podcast on Continuous Electronic Monitoring

In this podcast AAMI Foundation’s Healthcare Technology Safety Institute, Frank Overdyk, MD, professor of anesthesiology at Hofstra North Shore-LIJ School of Medicine and executive director for research at North American Partners in Anesthesia, and Tim Vanderveen, vice president of CareFusion’s Center for Safety and Clinical Excellence, make the case for continuous electronic monitoring and address the challenges stakeholders face in trying to bring about this change.

Dr. Overdyk is an advisor to the Physician-Patient Alliance for Health & Safety and, with Mr. Vanderveen, is a co-chair of the National Coalition to Promote Continuous Monitoring of Patients on Opioids.

opioids partner

To listen to the podcast, please see “Episode 7” by clicking here.

Patient Monitoring

Campaign to Promote Continuous Monitoring of Patients Receiving Opioids

The Physician-Patient Alliance for Health & Safety enthusiastically applauds the Association for the Advancement of Medical Instrumentation (AAMI) Foundation’s newly launched campaign to promote continuous monitoring of all patients receiving opioid analgesics to manage their pain.

opioids partner

To exemplify its support for the AAMI Foundation’s National Coalition to Promote Continuous Monitoring of Patients on Opioids Campaign, Physician-Patient Alliance is co-convening with AAMI a by-invitation campaign kick-off event in Chicago on November 14, 2014.

Respiratory compromise is the second-most frequently occurring preventable patient safety issue. Along with higher mortality rates and longer hospital and ICU stays, respiratory compromise costs millions of healthcare dollars every year,” said Physician-Patient Alliance Executive Director and Founder Michael Wong, JD. “We look forward to partnering with physicians, patients and families, nurses, hospital administrators, and industry partners to build the case for saving lives through continuous monitoring for all patients on opioids.”

Opioid-induced respiratory compromise is a life-threatening condition that can be prevented with the use of continuous electronic monitoring. Such monitoring, Mr. Wong added, might have saved the life of 18-year-old Amanda Abbiehl. Amanda’s tragic story leads off the cover story, which originally published in the November/December 2013 issue of BI&T (Biomedical Instrumentation & Technology), a bimonthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation, www.aami.org.

At the campaign kick-off event, Amanda’s story will be shared by her father, Brian Abbiehl, who is on the board of directors for Physician-Patient Alliance and who, along with his wife, Cindy, founded A Promise to Amanda Foundation as a tribute to their daughter and to educate patients and their loved ones about the need for continuous monitoring of patients receiving opioids.

Retired Michigan State Trooper Matt Whitman will also share his own experience with opioid-induced respiratory compromise that could have ended in tragedy but “by the grace of God.”

The Physician-Patient Alliance and its Board of Advisors will be well represented at the campaign kick-off event:

  • Frank Overdyk, MSEE, MD (Executive Director for Research, North American Partners in Anesthesiology; Professor of Anesthesiology, Hofstra North Shore-LIJ School of Medicine) will co-moderate the event.
  • Kenneth P. Rothfield, M.D., M.B.A. (Chairman, Department of Anesthesiology, Saint Agnes Hospital (Baltimore, MD) will present “From Engagement to Implementation: Initiation of Continuous Pulse Oximetry in a Community Teaching Hospital.”
  • Gina Pugliese, RN, MS, FSHEA (Vice President, Premier Safety Institute) will moderate the break-out session “Clinician & Patient Acceptance.”
Capnography, Patient Safety, Post-Operative Monitoring, Postoperative Pain

Respiratory Therapy Magazine Highlights Flawed Monitoring Practices, Features PPAHS Article on Opioid Safety

by Sean Power

Volume 8 Number 1 February-March 2013 of Respiratory Therapy Magazine features an article by the Physician-Patient Alliance for Health & Safety that summarizes the points of view of four experts.

The magazine calls attention to four flawed monitoring practices discussed at a webinar involving Dr. Frank Overdyk, Professor of Anesthesiology at Hofstra North Shore-LIJ School of Medicine; Ray Maddox, Director of Clinical Pharmacy, Research and Pulmonary Medicine at St. Joseph Candler; Tammy Haslar, Oncology Clinical Nurse Specialist at the Franciscan Alliance at St. Francis Health, and Debbie Fox, Director of Respiratory Care at Wesley Medical Center.

Let’s recap those flawed practices:

  1. Trusting that intermittent spot checks of vital signs are sufficient for assessing respiratory rate and CO2 levels.
  2. Continuously monitoring only “high risk” patients.
  3. Relying on pulse oximetry alone to detect respiratory depression.
  4. Implementing a monitoring program without creating an education plan.

The article present solutions for each problem highlighting that safer patient care is within reach of hospitals. The Respiratory Therapy Magazine feature comes on the heels of Patient Safety Awareness Week during which the PPAHS re-announced our PCA Safety checklist.

To hear a replay of the webinar, please click here.

What other flawed monitoring practices have you encountered? What solutions work?

Patient Safety

Patient Safety Checklist Helps Address Opioid Warnings from TJC: Physician-Patient Alliance for Health & Safety checklist supports Sentinel Event Alert on opioid hazards

By Sean Power and Michael Wong

This article is reprinted with the permission of Patient Safety & Quality Healthcare (PSQH).  Improving patient safety is one of the most urgent issues facing healthcare today. PSQH is written for and by people who are involved directly in improving patient safety and the quality of care.

On August 8, The Joint Commission issued a Sentinel Event Alert on the safe use of opioids in hospitals. The Alert discussed the significance of accurate pain assessment and effective pain management plans. Tips offered by The Joint Commission included:

  • Screen patients for respiratory depression risk factors.
  • Assess any history of analgesic use or abuse, duration, and possible side effects to identify potential opioid tolerance or intolerance.
  • Individualize the treatment and adopt a multimodal approach. Such an approach combines strategies including psychosocial support, the coordination of care, and the promotion of healthy behavior, among others.
  • Not all pain will go away. Focus on managing pain rather than eliminating it.

The Physician-Patient Alliance for Health & Safety (PPAHS) is an advocacy group dedicated to improving patient health and safety. Doing so involves many facets. Hospitals need to leverage technology to provide necessary monitoring of patient vital signs. Management needs to enable healthcare providers to reduce safety risks by implementing procedures centered on patient safety. Physicians and patients alike need access to information on patient safety and must take an active role in preventing adverse events.

The PPAHS recently released a safety checklist that supports hospitals, management, physicians, and patients in their mission to improve patient safety. The checklist is specifically designed for patient-controlled analgesia (PCA) pumps. Focusing on essential steps that increase patient safety for individuals using PCA pumps, the PCA Safety Checklist will help hospital staff achieve better clinical patient safety outcomes. The PCA Safety Checklist can be viewed and downloaded for free by clicking here.

Below we present four takeaways from The Joint Commission’s Sentinel Event Alert. Following these takeaways will likewise lead to better clinical outcomes that involve the use of opioids for pain management.

1. Implement effective processes when dealing with opioids.

Ongoing clinical monitoring requires policies and procedures that assess the adequacy of respiration and the depth of sedation. In addition to monitoring respiration adequacy and sedation depth, be sure to observe oxygenation and ventilation by using pulse oximetry and capnography. As The Joint Commission Alert advises, it is important to educate staff not to rely on pulse oximetry alone because it can suggest adequate oxygen saturation in patients who are actively experiencing respiratory depression. Pulse oximetry does not detect changes in respiratory rate, depth of breathing, or pauses in breathing. As the Sentinel Event Alert points out, using capnography to monitor ventilation is a valuable addition to pulse oximetry, especially when supplemental oxygen is being used.

Policies and procedures should allow for a second-level review by a pain management specialist. A good policies portfolio will also include procedures for tracking and analyzing opioid-related incidents for quality improvement purposes.

Frank Federico, RPh (Patient Safety Advisory Group at The Joint Commission and executive director at the Institute for Healthcare Improvement) commented on the Alert, saying, “Even with well-developed procedures in place, adverse events with PCA pumps can occur even without a healthcare professional ever committing an error. Moreover, pulse oximetry and capnography are essential risk prevention tools in any pain management plan.”

2. Leverage safe technology when managing pain with opioids.

The Sentinel Event Alert observes that separating sound-alike and look-alike opioids reduces the risk of human error. Further, by building red flags into e-prescribing systems, medical staff can ensure patient adherence to dosing limits. These measures, coupled with the PCA checklist discussed above, can help staff properly oversee of the use of patient-controlled analgesia (PCA) pumps and reduce the risk of over-sedation.

According to Frank Overdyk, MD (executive director for research, North American Partners in Anesthesiology, and professor of anesthesiology at Hofstra University School of Medicine), “PCA pumps provide optimum patient controlled analgesia and high patient satisfaction, yet despite their built-in safety mechanisms, can result in dangerous levels of over-sedation and respiratory depression. These pumps are safest in tandem with continuous electronic monitoring, a combination of pulse oximetry and/or capnography. We need to avoid unrecognized, critical respiratory depression, which can cause tragedies like that of Amanda Abbiehl.”

Amanda Abbiehl was an 18-year old, who tragically died in a PCA-related incident. For more on her story, please visit www.promisetoamanda.org

3. Introduce appropriate education and training on opioid use.

Advise clinicians who prescribe pain medication on the risks of PCA pumps and provide them with a diverse pain management toolset. Such a toolset, says the Alert, includes physical therapy, acupuncture, manipulation or massage, ice, music therapy, and non-narcotic analgesics.

“Even with alternative treatment plans,” cautioned Dr. Overdyk, “you need to consider all of the risks associated with these alternatives and select the best solution for the individual patient. Educate staff on the tell-tale signs and symptoms of opioid over-sedation and respiratory depression and the importance of frequent patient assessments. Show them how to develop a risk management plan for patients. In addition, teach patients about the risks and side effects of opioids and the importance of safe and secure storage of opioid analgesics at home.”

4. Use standardized tools to reduce opioid risk factors.

Standardized tools such as the Pasero Opioid-Induced Sedation Scale and the Richmond Agitation-Sedation Scale can help screen patients for risk factors associated with over sedation and respiratory depression.

“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,” says Ana Pujols McKee, MD, executive vice president and chief medical officer, The Joint Commission. “By engaging in a comprehensive approach to assessment, monitoring, and patient education, opioid overuse and associated harm can be prevented.”

Mr. Federico encourages the use of standard protocols like the PPAHS 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.”

Patient-Controlled Analgesics

Errors with patient-controlled analgesia (PCA): just the tip of the iceberg

by Michael Wong

Many readers emailed studies, suggestions, and comments regarding the estimate of 600,000 to 2 million PCA errors each year. These readers not only indicated the magnitude of the problem, but also a way to detect respiratory depression. Here are these further studies and thoughts.

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.”

First, regarding Professor Rodney Hicks’ rule of thumb that for every reported error, there are 300-1000 unreported instances, thank you Professor Hicks for supplying your unpublished dissertation, from which sources for his rule of thumb were given.

Although there have been a lot of studies on error reporting, probably the best two that support this estimate are:

  • On the lower end of 300, the study Kellier, N., Fitzpatrick, M., & Barach, P., “Analysis of adverse event reporting systems and geospatial mapping of Florida AHCA Code 15 data” Miami: Miami Center for Patient Safety (2004) provides that “near misses” reported to voluntary systems they studied “occur up to 300 times more often than events resulting in injury”.
  • On the upper end of 1,000, the study Flynn, E. A., “A brief history of medication errors” concluded that observation found 1,422 times the number of errors identified by spontaneous reports.

Second, corroborating studies provided by many readers shows how widespread is the usage of PCA. 0.1-1.0% of patients receiving PCA have serious respiratory depression, according to Dr. Richard Moon (Professor of Anesthesiology and Associate Professor of Medicine, Duke University Medical Center). In his presentation at the Anesthesia Patient Safety Foundation (APSF) workshop in 2006, Dr. Moon presented a talk entitled “Postoperative Pain Control and Respiratory Depression”, “Dr. Moon described how the fractal analysis of inter-breath intervals of these patients correlated with mean end-tidal CO2. He recommended that strategies to prevent opioid-induced respiratory depression should include patient triage, appropriate dosing, genetic screening (in the future), and bedside monitoring.”

When looking at the incidence of respiratory depression, Dr. Moon’s analysis is supported by the study by Dr Frank Overdyk (Professor of Anesthesiology and Perioperative Medicine at the Medical University of South Carolina) and his colleagues. This study found that when postsurgical patients undergoing PCA therapy were monitored with continuous oximetry and capnography, respiratory depression was identified in 41% of the patients. Moreover, as this study concluded:

Our incidence of RD by bradypnea is significantly higher than the 1%–2% incidence in the literature, using the same threshold criteria but more stringent duration criteria, while our incidence of RD based on desaturation is consistent with previous estimates. We conclude that continuous respiratory monitoring is optimal for the safe administration of PCA, because any RD event can progress to respiratory arrest if undetected.

Moreover, unfortunately, respiratory depression may be occurring with more frequency than most think. As Rob Hutchison (Associate Professor, Department of Pharmacy Practice, Texas A&M Health Science Center) says: “Respiratory depression occurs more often than most clinicians think with PCA.”

In a study led by Professor Hutchison, more instances of respiratory depression were detected in the capnography monitored patient group than the group without such monitoring:

In total, 146 episodes of respiratory depression were detected during the 36 hours on the general care nursing unit: 140 in the capnography group and six in the control group. All of these episodes were detected because the patient either took six or fewer breaths per minute or had an episode of apnea lasting longer than 20 seconds. Seventeen patients (15 in the capnography group and two in the control group) accounted for all episodes of respiratory depression. Pauses in breathing while sleeping, an indicator of OSA [obstructive sleep apnea] risk, were detected in the capnography group at twice the rate as in the control group (48% and 24%, respectively).

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

How often do errors with patient-controlled analgesia (PCA) occur?

by Michael Wong

Many readers of this website have asked, how often do errors with patient-controlled analgesia (PCA) occur?

In a retrospective analysis lead by Rodney Hicks (who at the time of the study was Manager, Patient Safety Research and Practice, United States Pharmacopeia), the magnitude, frequency, and nature of non-harmful and harmful medication errors associated with PCA were studied. (Professor Hicks is now Professor, Western University College of Graduate Nursing, Pomona, California).

Over the five-year review period, of the 919,241 medication errors records from the 801 reporting healthcare facilities, just 1% (or 9,571) were associated with PCA. Although 1% may seem insignificant, this analysis was based on the voluntary medication error reporting program, MedMarx.

“Although generalization of voluntary reported findings to the general population should be done cautiously,” as Professor Hicks points out, “The general rule of thumb is that for every reported event, there can be between 300-1,000 unreported events.”

Using this rule of thumb, based on 9,571 reported events, this would mean that between 2.8 million and 9.6 million total events (unreported & reported) occurred over the five-year period from July 1, 2000 to June 30, 2005. On an annualized basis, this would mean that about 600,000 to 2 million events per year could involve PCA.

“A further study would need to be done to ascertain the total number of PCA events,” explains Professor Hicks, “but the problem is extensive in my opinion.”

Moreover, when the study looked at the number of events that caused harm, there were 624 records of PCA associated with harm, corresponding to 6.5% of the patients. Again, while 6.5% may seem small, as the study found, “By comparison, during the same period, only 1.5% of all other errors reported to MedMarx led to harm. This represents a fourfold higher relative risk of harm for PCA events.”

“All health care disciplines were implicated in the errors, including physicians, pharmacists, and nurses” Hicks reported.  “Therefore, it will take an inter-disciplinary team to resolve the problems”.

As Professor Hicks concludes:

Our analysis was in no means trying to discourage the use of PCA pumps. Many studies have shown the benefits of using PCA, including improved pain management, better utilization of nursing resources, increased patient satisfaction, and improved pulmonary function.

However, this is clearly an area that standardization needs to occur and organizations need to invest in training and policies and procedures as well as equipment – all areas to promote safety.

Moreover, although elimination of error is critical, studies have shown even a correctly programmed PCA pump poses patient safety risks. In their study, “Continuous Oximetry/Capnometry Monitoring Reveals Frequent Desaturation and Bradypnea During Patient-Controlled Analgesia”, Dr. Frank Overdyke and his colleagues point out, “The most serious complication of patient-controlled analgesia (PCA) is respiratory depression (RD).” They found that:

continuous respiratory monitoring is optimal for the safe administration of PCA, because any RD event can progress to respiratory arrest if undetected.

As Ray Maddox and his colleagues point out in their study “Intravenous Infusion Safety Initiative: Collaboration, Evidence-Based Best Practices, and ‘Smart’ Technology Help Avert High-Risk Adverse Drug Events and Improve Patient Outcomes”:

Even correctly programmed, appropriate doses of opiates can suppress respiration and decrease heart rate and blood pressure. Episodes of bradypnea and desaturation can escalate to respiratory depression (RD) requiring rescue. The success rate for in-hospital cardiopulmonary resuscitation remains less than one in five patients. If detected early, most cases of opioid-induced respiratory depression can be treated with naloxone. However, severe cases can be fatal.The risk of patient harm due to medication errors with PCA pumps is 3.5-times the risk from any other type of medication administration error.

These researchers therefore recommend:

Capnographic monitoring—measurements of ventilation using respiration and exhaled carbon dioxide (EtCO2)—is particularly important because it can provide an earlier warning of respiratory depression than pulse oximetry (SpO2) in some patient populations.

What do you think? Are you aware of any other studies that have looked at PCA error incidence rates?

Patient-Controlled Analgesics, PCA, Post-Operative Monitoring

Post-Surgical Patients Require Better Monitoring

by Michael Wong

PPAHS encourages the adoption of the Anesthesia Patient Safety Foundation (APSF) recently released recommendations to improve the safety of patients by continuously monitoring patients following surgery.

According to the HealthGrades study of patient safety in American hospitals, “failure to rescue” and postoperative respiratory failure (also known as “Code Blue”) are the first and third most common patient safety related adverse events affecting Medicare patients accounting for 113 events per 1,000 at-risk patient admissions.

“These adverse events which affect both Medicare and non-Medicare patients result in death or anoxic brain injury in the majority of cases,” observes Dr. Daniel Sessler, who is Professor and Chair of the Department of Outcomes Research at the Cleveland Clinic, and Director of the Outcomes Research Consortium which is anesthesia’s largest academic research organization. The Consortium conducts research in anesthesia, critical care, and comprehensive pain management.

“Continuous respiratory monitoring, including the use of both capnography and pulse oximetry, is essential for the safe administration of patient-controlled analgesics,” explains Professor Sessler. “A patient experiencing respiratory depression, if undetected, can easily progress to respiratory arrest and consequent brain damage or death.”

A capnograph is a monitoring device that measures the concentration of carbon dioxide” that a person breathes out in exhaled air and displays on a numerical readout and waveform tracing; and a pulse oximeter is a device for measuring the amount of oxygen in blood.

To improve patient safety and health outcomes, the Anesthesia Patient Safety Foundation recently released recommendations calling for continuous electronic monitoring of oxygenation and ventilation.

As Dr Robert Stoelting (President, Anesthesia Patient Safety Foundation) explains, “Clinically significant drug-induced respiratory depression (oxygenation and/or ventilation) in the postoperative period remains a serious patient safety risk that continues to be associated with significant morbidity and mortality.”

How monitoring is currently conducted on postoperative patients may not be enough. As the APSF recommendations state, “Intermittent ‘spot checks’ of oxygenation (pulse oximetry) and ventilation (nursing assessment) are not adequate for reliably recognizing clinically significant evolving drug-induced respiratory depression in the postoperative period.” In other words, better monitoring for patient safety is needed and APSF recommends that use of current technology to improve patient safety.

Just ask Carly Ann Pritchard who suffered an ankle injury and then underwent surgery to reduce lingering pain from her ankle injury. Unfortunately, although she survived surgery, she suffered brain damage because of an accidental overdose from a morphine-filled pain pump — after surgery. A California appeals court recently upheld a jury’s award of about $9.9 million in damages.

Moreover, as the APSF guidelines provide, using capnography and oximetry monitoring on all postoperative patients is recommended, and not just for patients who may have an obvious increased risk of postoperative respiratory insufficiency (such as those with obstructive sleep apnea, obesity, or chronic opioid therapy).

Observes Dr. Frank Overdyk (Professor of Anesthesiology and Perioperative Medicine at the Medical University of South Carolina), “Serious postoperative adverse events such as deaths and anoxic brain injuries due to opioid acute pain management are a significant and preventable threat to patients, for which all institutions and healthcare providers must have zero tolerance”.

However, waiting for future technology to manage this issue is not acceptable. As Dr Stoelting explains, “Future technology developments may improve the ability to more effectively utilize continuous electronic monitoring of oxygenation and ventilation in the postoperative period.  However, maintaining the status quo while awaiting newer technology is not acceptable” [Dr Stoelting’s emphasis].