Psychotropic Medication Used Without Informed Consent
Summary
The facility failed to ensure that one sampled resident was free from chemical restraint use by not obtaining informed consent for Seroquel and not documenting the indication for its use with the resident or the resident’s responsible party. The resident had diagnoses including unspecified dementia, psychotic disturbance, mood disturbance, and anxiety disorder, and the record showed the resident lacked capacity to understand and make decisions. The resident’s order summary included Seroquel 25 mg via G-tube twice daily, and the facility’s informed consent form indicated that no informed consent had been received for the medication at the time it was reviewed. The resident’s records also showed that the medication was being monitored for behaviors such as unconsolable screaming and yelling, but the monthly behavioral summary was left blank and the nursing administration reports showed no such behaviors during some reviewed periods and only one episode during another period. The care plan identified agitation manifested by yelling and screaming and directed staff to administer medication per physician order. The pharmacist questioned the use of the antipsychotic for dementia-related behaviors and noted that the medication was not FDA approved for that use, while the psychiatrist later disagreed and signed the review form stating the resident had episodes of agitation. Interviews with RN, DON, MD, pharmacist, and MDIR confirmed that Seroquel had been continued after the resident returned from the acute care hospital, that informed consent had not been obtained from the resident or a representative at the time the medication was started, and that the physician signed the informed consent form much later. The DON and RN acknowledged the resident was receiving psychotropic medication without informed consent. The record also showed that no gradual dose reduction had been attempted, and the psychiatrist note did not indicate that dose reduction was clinically contraindicated or that the current dose was the lowest effective dose. The resident was observed lying in bed with both bed rails up and opened eyes when voice prompted.
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