Fatal Methotrexate Dosing Error and Ignored Medication Alert
Summary
The deficiency involves the facility’s failure to ensure a resident was free from significant medication errors by not following its Medication Administration policy regarding right dose, right time, and appropriate response to medication alerts. A resident with rheumatoid arthritis was discharged from an acute hospital to the facility with an order for methotrexate 20 mg by mouth every Friday, as documented in the hospital discharge instructions. The resident’s diagnoses included rheumatoid arthritis, shortness of breath, and difficulty walking, and the Minimum Data Set also reflected an active diagnosis of rheumatoid arthritis. Despite this, when the orders were entered into the facility’s system, the Physician’s Order Sheet showed methotrexate 20 mg by mouth every day instead of weekly. When the methotrexate order was entered into the facility’s computer system, a medication alert was generated stating that the order was outside the recommended dose or frequency, specifying that the dosing regimen of 2 tablets daily exceeded the usual dosing regimen of 0.25 mg to 2.5 mg tablets every 7 days and that the daily frequency exceeded the usual weekly frequency. Facility staff interviews indicated that nurses understood medication alerts to mean there was a contraindication or concern requiring contact with the pharmacy or physician to clarify safety, but there was no evidence this alert was acted upon. The Medication Administration Record for November and December showed that the resident received methotrexate 20 mg by mouth daily on multiple dates over several weeks, consistent with the incorrect daily order. The care plan identified methotrexate as a black box warning medication with potential for bone marrow suppression and called for monthly drug regimen review by a pharmacist, yet the pharmacist’s order history and drug regimen review documents showed the methotrexate 20 mg daily order was reviewed on two dates in November with no recommendations and was listed as reviewed without requiring any recommendations. Progress notes documented that in mid-December the resident developed sore throat, difficulty swallowing, epistaxis, lip and chin swelling, and bloody stool. Nursing staff notified the physician, obtained orders including nasal spray, and the resident was sent to the hospital for further evaluation due to ongoing nosebleeds. Hospital emergency documentation recorded that the resident presented with life-threatening cytopenias, critical neutropenia, thrombocytopenia, anemia, acute bleeding, and organ dysfunction, with a diagnosis of methotrexate toxicity with multi-organ involvement and sepsis, and confirmed with the nursing home that the resident had been receiving methotrexate daily, with suspected overdose. The hospital history and physical also documented confirmation from the nursing home that methotrexate was being given daily. The hospital discharge summary described a prolonged course for methotrexate toxicity with severe thrombocytopenia, pancytopenia, septic shock, acute renal failure requiring dialysis, and respiratory failure, after which the resident was transitioned to comfort care and hospice. The death certificate listed acute renal failure, methotrexate toxicity, and rheumatoid arthritis, and stated that the resident ingested a toxic amount of methotrexate. The facility’s Medication Administration policy required medications to be administered as ordered by the physician, in accordance with professional standards, ensuring the six rights including right dosage and right time, use of drug reference material if unfamiliar, special handling of immunosuppressant medications, and reporting and correcting discrepancies, which were not followed in this case. Interviews with facility staff further clarified the actions and inactions leading to the deficiency. The DON stated that the resident was admitted in November and began having swallowing problems and nosebleeds around the middle of December, and that the resident was sent to the hospital due to continued nosebleeds. The DON reported that near the end of December a hospital case manager informed her that the resident appeared to have been receiving methotrexate daily instead of weekly. Upon comparing the facility MAR with the hospital discharge orders, the DON confirmed the resident had been given 20 mg methotrexate daily instead of 20 mg weekly, and that the pharmacy-supplied bubble pack was labeled for daily administration. The nurse who admitted the resident and entered the discharge orders into the facility system stated she entered the orders but could not recall how or why the methotrexate frequency was changed from weekly to daily. The ADON stated that this error could have been caught and was unsure why the system failed. The manufacturer’s black box warning for methotrexate, reviewed by surveyors, emphasized that methotrexate can cause serious, potentially fatal toxic reactions and should only be used by physicians experienced with antimetabolite therapy, underscoring the high-risk nature of the medication that was not properly managed according to facility policy and system alerts.
Penalty
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