CMS Final Rule – §483.45 Pharmacy Services

Post 20 of 108

Implementation Date: Phase 1 – November 28, 2016¹

Section 483.45 incorporates regulations previously contained in §483.60 and was revised to include additional requirements involving pharmacist review of medical records, changes to existing requirements concerning “anti-psychotic” drugs to include “psychotropic” medications, and provisions related to “irregularities” or “unnecessary” use of psychotropic drugs.

Currently, a pharmacist is required to conduct a monthly drug regimen review (DRR). The revised regulation expands the requirements for a pharmacist review of the medical record for each resident’s medical record concurrently with the DRR at least once a month, or when the resident is new to the facility or a prior resident returns or is transferred from a hospital or other facility.

Section (c)(3) defines psychotropic drugs as “any drug that affects brain activities associated with mental processes and behavior. Included under this definition are drugs including: (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic.

Section (c)(4) requires the pharmacist to report any irregularities to the attending physician, the facility’s medical director and director of nursing in a separate, written report. Section (d) defines “Irregularities” to include, but are not limited to, any unnecessary drug when used: (1) In excessive dose (including duplicate drug therapy); or (2) For excessive duration; or (3) Without adequate monitoring; or (4) Without adequate indications for its use; or (5) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or (6) Any combinations of the foregoing reasons. The attending physician must document the resident’s medical record that the irregularity was reviewed and what, if any, action was taken to address it.

Section (e) addresses comprehensive resident assessment for unnecessary use of psychotropic drugs. Prescribing psychotropic drugs is limited to necessary treatment for a specific condition documented in the clinical record. In addition, PRN orders for psychotropic drugs are limited to 14 days and cannot be renewed   unless the attending or prescribing physician evaluates the resident for the appropriateness of that medication.

Facilities will need to establish and maintain policies and procedures addressing the monthly DRR as well as timeframes for the pharmacist to take action needed to avoid potential harm to the resident. The increased responsibilities for a pharmacist to concurrently review the medical record during the monthly DRR coupled with reporting requirements upon identifying “irregularities” will ensure a thorough review of a resident’s drug regimen and give the resident protection from inappropriate drugs. While the oversight of the patient’s medications will increase with the implementation of the regulations, the rule gives facilities specificity on compliance requirements but allows the facilities flexibility in choosing how to comply.

By Denise Bloch

Denise Bloch








¹Section (c)(2) pharmacist review of resident’s medical chart and section (e) Psychotropic drugs will be implemented by November 28, 2017.

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