F0757

D

Use of High-Risk Sedating Drug Combination Without Required Assessment or Monitoring

Weaverville, California Survey Completed on 03-24-2026

Penalty

No penalty information released

Summary

The deficiency involves the facility’s failure to ensure a resident’s drug regimen was free from unnecessary medications when a combination of three drugs—intramuscular haloperidol 5 mg, lorazepam 2 mg, and diphenhydramine 50 mg—was ordered and administered nearly simultaneously for agitation. The resident was an older adult with a diagnosis including depression and a BIMS score of 15/15, indicating intact decision-making ability. On the identified night, the Medication Administration Record showed that diphenhydramine and lorazepam were given at 1:01 a.m. and haloperidol at 1:02 a.m. The DON confirmed this was a "B52" combination commonly used in emergency room settings for severe agitation and acknowledged she had never seen it used in this skilled nursing facility. The facility pharmacist stated that this combination should generally be avoided in the skilled nursing setting.

The facility’s own policies and nationally recognized clinical resources highlighted concerns with this medication regimen. The AGS 2023 Beers Criteria listed haloperidol, lorazepam, and diphenhydramine as medications best avoided in most older adults, with haloperidol associated with increased stroke risk, lorazepam with increased falls and fractures, and diphenhydramine with increased confusion and falls. Epocrates indicated that using these three medications together should be avoided due to risks of respiratory depression and psychomotor impairment. Facility policies on psychotropic medication use and behavioral assessment required that pertinent non-pharmacological interventions be attempted and documented, that staff observe and document the effectiveness and adverse consequences of psychotropic medications, and that physicians change or stop problematic medications or clearly document why benefits outweigh risks.

Despite these requirements, the resident’s record lacked documentation of behaviors in the days immediately before or after the medication administration, and there was no documentation of non-pharmacological interventions attempted prior to giving the three medications. The progress note from the night of administration described the resident screaming, yelling, blocking the room entrance with his wheelchair, wheeling to the nursing station, and glaring at staff and other residents, and stated that the medications were effective, but there was no further monitoring documented for the remainder of the night. There was no care plan addressing behavior monitoring or the use of haloperidol, lorazepam, or diphenhydramine, and no documentation of an IDT meeting to discuss this medication use. Informed consent forms for each of the three medications listed only "Severe Agitation" as the diagnosis or signs and symptoms, without specifying behaviors to be monitored or alternative treatments and risks as required by the facility’s informed consent policy. The DON also acknowledged that a change in condition assessment was not completed following the resident’s behaviors and the administration of the three medications, contrary to the facility’s policy requiring documentation and comprehensive assessment when there is a significant change in a resident’s physical or mental condition.

The Medical Director stated that the combination of haloperidol, lorazepam, and diphenhydramine is standard for enforced sedation for people who are out of control and confirmed that it was intentionally used in this case in the skilled nursing setting rather than transferring the resident to the emergency room. A subsequent progress note by the Medical Director several days later documented that the resident had been administered the three medications once that night and "has been fine ever since." However, there was no contemporaneous documentation of monitoring for efficacy and adverse consequences as required by the facility’s behavioral and psychotropic medication policies, and no evidence in the record that the physician documented why the benefits of this high-risk combination outweighed the known risks in an older adult. Collectively, these omissions and the use of a high-risk drug combination without required assessments, non-pharmacologic attempts, monitoring, care planning, and complete informed consent constituted the deficiency in ensuring the resident’s drug regimen was free from unnecessary drugs.