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 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.