Hospital Harm - Opioid-Related Adverse Events

HH-ORAE

This measure defines the indication of a harm for an opioid-related adverse event by assessing administration of an opioid antagonist.

Inpatient hospitalizations: Includes time in the emergency department and observation when the transition between these encounters (if they exist) and the inpatient encounter are within an hour or less of each other.

To calculate the hospital-level measure result, divide the total numerator events by the total number of qualifying encounters (denominator).

Qualifying encounters (denominator) include all patients 18 years of age or older with at least one opioid medication administered outside of the operating room.

To create the numerator:

1. First, start with those encounters meeting denominator criteria.

2. Next, remove all events where an opioid or opioid antagonist was only administered in the operating room.

Opioid antagonist administrations in the operating room are excluded because they could be part of the sedation plan as administered by an anesthesiologist. Encounters that include use of opioid antagonists for procedures and recovery outside of the operating room (e.g., bone marrow biopsy and PACU) are included in the numerator, as it would indicate the patient was over-sedated. Note that should a facility not utilize temporary patient locations, alternative times may be used to determine whether a patient is in the operating room during opioid antagonist administration. Since anesthesia end time could represent the time the anesthesiologist signed off, and thus may include the patient’s time in the PACU, this should be avoided.

3. Next, remove all events where the opioid antagonist was administered via an enteral route. Only opioid antagonists given by a non-enteral (i.e., intravenous, intramuscular, subcutaneous, intranasal, inhalation) route are considered.

4. Finally, remove all administrations of opioid antagonist that were given greater than 12 hours following hospital administration of an opioid medication.

This eCQM is an episode-based measure. An episode is defined as each inpatient hospitalization or encounter that ends during the measurement period.

This version of the eCQM uses QDM version 5.6. Please refer to the eCQI resource center https://ecqi.healthit.gov/qdm) for more information on the QDM.

Opioids are often the foundation for sedation and pain relief. Opioid-based analgesia continues to be the most commonly used treatment in postoperative pain management, with more than 95% of surgical patients receiving opioids during their hospitalization (Baker et al., 2020). However, use of opioids can also lead to serious adverse events, including constipation, over sedation, delirium, and respiratory depression (Urman, 2022). Opioid-related adverse events (ORADE) have both patient-level and financial implications. The presence of an ORADE was associated with a 55% longer postoperative length of stay, 29% lower odds of discharge home, and 2.9 times the odds of death (Urman, 2021). Patients who experience this event have been noted to have 55% longer lengths of stay (LOS), 47% higher costs, 36% higher risk of 30-day readmission, and 3.4 times higher payments than patients without these adverse events (Kessler et al., 2013). For surgical patients, occurrence of opioid-related adverse events was associated with an increase of 1.6 days in LOS and $8225 more in cost for the index hospitalization (Shafi et al., 2018). Numerous studies report the additive (risk-adjusted) hospitalization cost burden of surgical patients with ORADEs to be between $4350–$8225, representing a 27–47% increase in (risk-adjusted) admission costs (Khanna, 2021).

Most opioid-related adverse events are preventable. Each year, adverse drug events (ADE) account for nearly 700,000 emergency department visits and 100,000 hospitalizations. Nearly 5% of hospitalized patients experience an ADE, making them one of the most common types of inpatient errors (https://psnet.ahrq.gov/primer/medication-errors-and-adverse-drug-events, 2019). Additionally, in a closed-claims analysis, 97% of adverse events were judged preventable with better monitoring and response (Lee et al., 2015). Naloxone administration is often used as an indicator of a severe opioid-related adverse event, and implementation of this measure can advance safe use of opioids in hospitals and prevent these serious and potentially lethal adverse drug events.

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Naloxone is an opioid reversal agent typically used for severe opioid-related adverse events. Naloxone administration has been used in a number of studies as an indicator of opioid-related adverse events (Lynn et al., 2017, Nwulu et al., 2013).

From Section 10 of the 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Lavonas et al., 2015), the following recommendation is listed for use of Naloxone:

Naloxone is a potent opioid receptor antagonist in the brain, spinal cord, and gastrointestinal system. Naloxone has an excellent safety profile and can rapidly reverse central nervous system (CNS) and respiratory depression in a patient with an opioid-associated resuscitative emergency.

In February 2022, FDA approved its abbreviated new drug application for Nalmefene hydrochloride injection, 2mg/2mL (1mg/1mL). Nalmefene is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids, and in the management of known or suspected opioid overdose (FDA, 2022). In contrast to Naloxone, the long half-life of Nalmefene is similar to or greater than that of many opioid receptor agonists (Britch et al., 2022), which could decrease the need for repeat drug administration. Data are lacking on use of Nalmefene for reversal of overdose due to fentanyl or its analogues. For emergent reversal of opioid overdose, Naloxone is a safer choice (Med Lett Drugs Ther, 2022).

2020 American Heart Association guidelines update for cardiopulmonary resuscitation continue to recommend Naloxone for a patient with suspected opioid overdose who has a definite pulse but no normal breathing or only gasping (i.e., a respiratory arrest), in addition to providing standard Pediatric Basic Life Support (PBLS) or Pediatric Advanced Life Support (PALS), it is reasonable for responders to administer intramuscular or intranasal naloxone. These recommendations are

identical for adults (https://cpr.heart.org/-/media/cpr-files/cpr-guidelines-files/highlights/hghlghts_2020_ecc_guidelines_english.pdf).