Executive Summary Checklist

Opioid  induced  respiratory  depression  is  a  leading  cause  of  totally preventable  patient  death \cite{APSS4Cite2,APSS4Cite1,APSS4Cite3}. It  also  causes serious patient harm. Patients receiving opioids in the hospital have almost twice the incidence of cardiorespiratory arrest  compared  to  other  patients \cite{Overdyk_2016}. Establishing  an  effective  program  to  reduce  opioid-induced  respiratory depression will require full hospital administration support to complete the following actionable steps:

The Performance Gap

Complications are inevitable and they are not always avoidable or the result of errors. However, when a patient dies because  of  a  complication  that  was  not  recognized  in  a  timely  manner  or  treated  appropriately,  that  death  is preventable  and  is  called  "Failure  to  Rescue."  Technology  and  knowledge  now  exist  to  anticipate  and  head  off  a serious  adverse  event  at  a  time  that  it  is  preventable  by  an  intervention.  The  combination  of  training,  technology, notification  and  computerized  data  analysis  will  allow  early  intervention  before  a  patient  reaches  a  critical  life threatening status.
Monitors  now  exist  to  detect  respiratory  depression  as  well  as  sepsis,  hemodynamic  instability,  bleeding,  cardiacthreats,  and  even  the  risk  of  patient  fall  at  a  time  that an  intervention  can  be  made  in  time  to  avert  a  potential disaster.  The  development  of  early  warning  systems  (EWS)  has  been  well  studied  and  validated  in  Europe  and Australia \cite{Alam_2014,Ludikhuize_2012,Fullerton_2012,Smith_2013}. The technology to  support EWS is now robust and can be instituted very  easily into any institution. Even patients that have been discharged home can be monitored remotely.
In-hospital  mortality  after  surgery  is  higher  than  anticipated  and  has  multiple  factors  that  can  be  systematically addressed \cite{Pearse_2012}. Healthcare  leadership  is  largely  unaware  of  significant  improvement  in  technology  that  can  detect  a patient  who  is  deteriorating  and  alert  the  caregivers  prior  to  an  adverse  event  occurring,  such  as  postoperative respiratory depression.
After  the  Institute  of  Medicine  described  failure  to  rescue  as  a  key  issue  in  healthcare  quality  in  2001,  failure to rescue  was  identified  as  a  key  area  for  improvement  in patient  safety \cite{APSS4Cite11}. A  decade  later,  a  study  looked  at  patient safety  indicators  for  40  million  hospitalized  patients  and concluded  that  many  deaths  and  permanent  disabilities could  still  be  avoided  if  healthcare  systems  adopted  safe  practices  and  implemented  systems  that  facilitate  patient safety \cite{APSS4Cite12}. The  following  patient  safety  indicators  accounted  for  68%  of all  failure-to  rescue  patient  safety  events: death  among  surgical  inpatients  with  serious  treatable  complications,  pressure  ulcer,  postoperative  respiratory failure,  postoperative  sepsis.  The  study  further  identified  that  the  cost  associated  with  postoperative  respiratory failure alone in the U.S. Healthcare System is $2 billion.
While opioid use is safe for most patients, opioid analgesics are associated with adverse effects and cause respiratory depression in significant number of post-surgical patients, who often receive them for pain management \cite{Vila_2005,1,APSS4Cite15,Jarzyna_2011,APSS4Cite17}. Of opioid-related adverse drug events – including deaths – that occurred in hospitals and were reported to The Joint Commission’s Sentinel Event database (2004-2011), 47% were wrong dosing medication errors, 29% were related to improper monitoring of the patient, and 11% were related to other factors including excessive dosing, medication interactions, and adverse drug reactions.
Failure to Rescue postoperative respiratory depressions can be prevented through appropriate pain management and dosing  approaches,  surveillance  to  identify  patients  at  risk  for  Failure  to  Rescue,  notification  to  providers  of significant changes in patient condition, and automated decision support to ensure appropriate therapies are initiated in  a  timely  manner.  A  landmark  study  published  in  January  2010 by  Dartmouth-Hitchcock  Medical  Center demonstrated  that  clinicians  using  Masimo  SET®  measure  through  motion  and  low  perfusion  pulse  oximetry  and Patient SafetyNet™ Remote Monitoring and Clinician Notification System identified patient distress earlier, which decreased  rapid  response  team  activations  by  65%,  ICU  transfers by  48%,  and  reduce  ICU  days  by  135  days annually \cite{Taenzer_2010}.  A  follow  up  report  by  Dartmouth  in  2012 reported  that  since  December  2007  no  patients have  died  or had serious brain injuries as a result of respiratory depression from opioids. In addition, expanding monitoring to all general  and  thoracovascular  post-surgical  units  produced  similar  results  to  those  seen  in  the  original  orthopedic unit \cite{APSS4Cite19}. They  also  reported  savings  of  $58,459  saved  per patient  who  was  not  transferred  to  the  ICU  in the  original orthopedic unit ($76,044 vs. $17,585), equating to $1.48 million in annual opportunity cost savings in this one unit alone.
In 2011,  the  Anesthesia  Patient  Safety  Foundation recommended  that all  patients receiving  parenteral narcotics  be monitored  continuously  and  a  notification  system  be  used  to  indicate  to  caregivers  when  alarming  conditions occur \cite{APSS4Cite20}. In  August  2012,  the  Joint  Commission  issued  a  sentinel  event alert,  urging  all  healthcare  systems  to introduce measures to improve safety for patient receiving opioids, including systematic protocols to assess pain and appropriate opioid dosing, as well as continuous monitoring of oxygenation and ventilation \cite{APSS4Cite21}. In 2014 the Center for Medicare  and  Medicaid  Services  (CMS)  clarified  the  surgical  services  CoP  requirement  for  hospitals  to  have adequate  provisions  for  immediate  postoperative  care,  to  emphasize  the  need  for  postoperative  monitoring  for patients receiving IV opioid medications, regardless of where they are in the hospital \cite{APSS4Cite22}.
In spite of the calls to address failure to rescue for postoperative respiratory depression, pain assessment and opioid dosing  approaches  are  variable,  and  a  high  percentage  of  post-surgical  patients  on  parenteral  narcotics  are  not monitored  continuously.  The  lack  of  a  systematic  approach  to  prevent  failure  to  rescue  from  postoperative respiratory   depression   poses   significant   patient   safety, quality,   and   cost   of   care   implications.   Closing   the performance gap will require hospitals and healthcare systems to commit to action in the form of specific leadership, practice, and technology plans.

Leadership Plan

Practice Plan

  • Depending  on the  institution and  patient  populations  within  that institution, lower  alarm limits may be set to be conscious of alarm fatigue. Each institution should set limits to fit their specific patient population.
  • Depending  on the  institution and  patient  populations  within  that institution, lower  alarm limits may be set to be conscious of alarm fatigue. Each institution should set limits to fit their specific patient population.

Technology Plan

Suggested  technologies  are  limited  to  those  proven  to  show  benefit  or  are the  only  known  technologies  with  a particular capability. Other technology options may exist, please send information on any additional technologies, along with appropriate evidence, to info@patientsafetymovement.org.
  • Alternatively,  a  wired  network  can  be  used  which  allows  surveillance  of  patients  while they are in bed but not while they are ambulating.

Metrics

Topic

Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicator (PSI) #11 Postoperative Respiratory Failure RateRate of patients with postoperative respiratory failure per 1,000 elective surgical discharges for patients 18 years and olderas defined by the Agency for Healthcare Quality and Research (AHRQ)

Outcome Measure Formula

Numerator: Discharges, among cases meeting the inclusion and exclusion rules for the denominator, with either:
Denominator: Elective surgical discharges, for patients ages 18 years and older, with any-listed ICD-9-CM or ICD-10-PCS procedure codes for an operating room procedure. Elective surgical discharges are defined by specific DRG or MS-DRG codes with admission type recorded as elective.Exclude cases:
† If day of procedure is not available in the input data file, the rate may be slightly lower than if the information was available.
* Rate is typically displayed as Patients/1000 Elective surgical discharges

Metric Recommendations

Direct Impact: All elective surgical patients
Lives Spared Harm: