Failure to Monitor Seizure Medication Levels Leads to Toxicity
Penalty
Summary
The facility failed to ensure that monthly pharmacy reviews and laboratory monitoring for seizure medications were conducted in a timely manner for a resident with multiple diagnoses, including epilepsy and hemiplegia. The resident was prescribed several anticonvulsant medications, such as Phenobarbital, Levetiracetam (Keppra), Carbamazepine (Tegretol), Gabapentin, Dilantin, and Divalproex Sodium (Depakote). Despite being on these medications, there was a significant lapse in laboratory monitoring, with the last documented lab for seizure medication levels occurring in January. Pharmacy recommendations for ongoing lab monitoring were not addressed by the attending physician, and the pharmacist did not identify the need for additional lab tests during monthly reviews over several months. The resident experienced a decline in condition, including decreased food and fluid intake, functional decline, and increased dependence on staff for care. This change in condition led to the resident being sent to the hospital, where laboratory results revealed a critically high Phenobarbital level, well above the normal therapeutic range. Hospital records indicated that the elevated Phenobarbital level required immediate medical intervention, and neurology held the medication for a period due to toxicity concerns. The facility's documentation confirmed that no labs had been ordered to monitor the resident's seizure medications in the months leading up to the hospitalization. Interviews with facility staff, including the DON, corporate nurse, pharmacist, and physician, confirmed that appropriate laboratory monitoring for seizure medications had not been performed as required. The facility's policy stated that pharmacists should report medication irregularities and that these should be addressed in a timely manner, but this process was not followed. The pharmacy recommendation form requesting regular lab monitoring was not completed or signed by the physician, and the DON acknowledged the oversight. This deficiency was substantiated through record review, interviews, and policy review.