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CMS regulations limit PRN use of Psychotropic medications

By Tom Jeter, R.Ph., Director of Clinical Services


On November 28, 2017, CMS adopted new guidelines which included a new interpretation to the appropriate use of As Needed Psychotropic medications in the LTC setting. There continues to be some confusion about these new guidelines and what is required to stay in compliance. I hope to give some clarification of these new guidelines as found in the current State Operations Manual Appendix PP – Guidance to Surveyors for Long Term Care Facilities.

The Regulation:

The guidelines specifically state for PRN Orders for Psychotropic and Antipsychotic Medications:
“In certain situations, psychotropic medications may be prescribed on a PRN basis, such as while the dose is adjusted, to address acute or intermittent symptoms, or in an emergency. However, residents must not have PRN orders for psychotropic medications unless the medication is necessary to treat a diagnosed specific condition. The attending physician or prescribing practitioner must document the diagnosed specific condition and indication for the PRN medication in the medical record.”

The guidelines tends to imply that PRN psychotropic medication can be used as long as its for a specific condition, but further review of the regulations also show additional limitations with regard to categories of (1) PRN Antipsychotic medications and (2) All Other Non-Antipsychotic Psychotropic Medications (Sedatives/Anxiolytics, Hypnotics and Anti-Depressants).

PRN Anti-Psychotic Medications:

The guideline instructs the surveyor that for PRN antipsychotic orders that they are restricted to use only for 14 days with no exception requiring the physician or prescribing practitioner to first evaluate the resident before writing a new order for a PRN antipsychotic. This new order will also be limited to 14 days requiring evaluation again before writing another PRN antipsychotic. There are no exceptions in the regulations for true psychiatric resident i.e. Huntington’s, Schizophrenia. Even in these residents they must all be handled the same way limited to only a 14-day supply. For this reason Gayco has adopted an internal policy to add a 14-day automatic stop order for these PRN antipsychotic orders to decrease facility to burden and to help them stay in compliance when we
receive them. The use of the word “Indefinitely” in these orders would be consider inappropriate and out of compliance with these new regulations.

CMS Guidelines for evaluation of a resident before writing a new PRN Antipsychotic order:

As part of the evaluation, the attending physician or prescribing practitioner should, at a minimum, determine and document the following in the resident’s medical record:

• Is the antipsychotic medication still needed on a PRN basis?
• What is the benefit of the medication to the resident?
• Have the resident’s expressions or indications of distress improved as a result of the PRN medication?

All Other Non-Anti-Psychotic Psychotropic Medications:

(Sedatives/Anxiolytics, Hypnotics and Anti-Depressants)

For PRN orders for psychotropic medications, excluding antipsychotics there remains a 14-day limitation but there is a Surveyor Exception. Orders may be extended without the need for a new order if, the attending physician or prescribing practitioner believes it is appropriate and that the document there rationale in the residents medical record for extending the time period beyond 14- days and they give a specific duration for how long it is to be used.

Guidelines to Surveyors Key Elements of Noncompliance:

• PRN psychotropic medication ordered for longer than 14 days, without a documented rationale for continued use; or
• Failure to implement person-centered, non-pharmacological approaches in the attempt to reduce or discontinue a psychotropic medication; or
• Administering a new PRN antipsychotic medication for which the resident had a previous PRN order (for 14 days) but the medical record does not show that the attending physician or prescribing practitioner evaluated the resident for the appropriateness of the new order for the medication

Concluding remarks:

To further aide your facility to make sure you are compliant in these areas, Gayco has changed its Stop Order Policy to include the use of PRN Psychotropic for only 14 Days and a Facility Notification Form to let you know when an order is not compliant. Please see the policy and form below. If you have any further questions please contact your Gayco Pharmacist or Nurse Consultant.

State Operations Manual Appendix PP – Guidance to Surveyors for Long Term Care Facilities: Pg. 493-6