Unnecessary Long-Term Omeprazole Use Without Documented R/B Review
Summary
The facility failed to ensure that Resident 19’s drug regimen was free from an unnecessary medication. Resident 19 was an over-[AGE] year-old resident with diagnoses including age-related osteoporosis and gastro-esophageal reflux disease without esophagitis. Her record showed that GERD was diagnosed on [DATE], and the clinical record indicated she had no active GERD or other bowel disorders. Her MDS dated 2/4/26 showed a BIMS score of 6, indicating severe cognitive impairment. The resident’s physician orders showed she had been receiving alendronate 70 mg weekly for osteoporosis and Prilosec (omeprazole) 20 mg daily for GERD, with the omeprazole order dated 12/28/22. The manufacturer’s prescribing information for omeprazole stated that for GERD it is used for up to 8 weeks to heal acid-related damage to the esophagus, with an additional 4 weeks if needed to maintain healing, and that it is not known to be safe and effective when used longer than 12 months for this purpose. The prescribing information also stated that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, and that patients should use the lowest dose and shortest duration appropriate to the condition being treated. Resident 19 was also receiving three psychotropic medications—quetiapine, escitalopram, and mirtazapine—each of which has the ability to cause falls. During record review and interviews, the DON, ADON, and consultant pharmacist could not find documentation supporting the long-term use of omeprazole or a documented risk-versus-benefit assessment. The consultant pharmacist stated she understood the fracture risk and checked monthly for opportunities, but said she was nervous about reducing the PPI because of the resident’s psych issues and could not find documentation of a clinical rationale. The DON later stated that no recommendation to discontinue omeprazole was made for this resident, reflecting individualized clinical judgment based on her condition and risk profile.
Penalty
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