The long-term care survey process instructs surveyors to evaluate compliance with §483.45(c) Drug Regimen Review (F756), particularly focusing on how facilities respond to pharmacist-identified irregularities. During the monthly review, the consultant pharmacist must identify and report any irregularities. These findings must be documented in a separate, written report (paper or electronic) that includes, at a minimum, the resident’s name, the medication involved, and the nature of the irregularity. This report must be provided to the attending physician, medical director, and director of nursing, and the pharmacist must also document when no irregularities are identified with a signed and dated statement.
Facilities are expected to ensure that identified irregularities are acted upon. The attending physician must document in the resident’s medical record that the irregularity was reviewed and what action, if any, was taken. If the physician determines no change is necessary, the rationale must be clearly documented in the medical record. Surveyors frequently cite facilities when pharmacist recommendations are present but lack evidence of physician review or response.
Timeliness is also a key area of focus. The urgency of reporting depends on the potential for serious adverse outcomes. For example, immediate notification is expected for issues such as bleeding in a resident receiving anticoagulants or a suspected allergic reaction. Additionally, facilities must develop and maintain policies and procedures for the drug regimen review process, including defined timeframes and steps to be taken when irregularities are identified. The pharmacist’s findings are considered part of the resident’s medical record and must be readily accessible.