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  • Stephen Boulanger

Phase Two CMS Pharmacy Requirements: Part One

Are you ready for the next roll out of CMS updates? Mark your calendars for November 28th. This is when Phase 2 of the regulation changes go in to affect. To help you prepare, we will be highlighting any changes that impact the way medications are handled, documented, stored, etc. Some of the new information surrounding medications is easy to locate, like §438.45 Pharmacy Services, but other guidelines are co-mingled within different sections and can be overlooked.

F-tag 425 §483.45 Pharmacy Services: Psychotropic Drugs and PRN use:

Definition of psychotropic drug – any drug that affects brain activities associated with mental processes and behavior.

These drugs include but are not limited to drugs in the following categories: ‒ Anti-psychotics ‒ Anti-depressants ‒ Anti-anxiety ‒ Hypnotics • Please note that the finalized definition does not include opioid analgesics or other drugs with similar effects.

Limitation on As Needed (PRN) Orders of Psychotropic Drugs: • General rule – PRN orders of psychotropic drugs are limited to 14 days and must be used to treat a condition that is documented in the clinical record. • Two exceptions: 1. If the attending physician or prescribing practitioner believes it is appropriate for the PRN order to be extended beyond the 14 days, he or she should document their rationale in the resident’s medical record and indicate the duration for the order. 2. PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication and documents clinical rationale.


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