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Changes to the SOM Related to the Use of Psychotropic Medications
QSO-25-07-NH, dated 11/18/24, announced significant revisions to the LTC survey process, and includes changes related to the use of psychotropic medications. Per QSO-25-12-NH, dated 01/15/25, surveyors will begin implementing the changes detailed in the memo on 03/24/2025.
1. F758 - This regulation, regarding unnecessary drugs (psychotropics), is no longer in effect. The regulatory requirements for F758 (§483.45(c)(3), and §483.45(e)) have been relocated to F605 (Freedom from chemical restraints imposed for purposes of discipline or convenience and that are not required to treat the resident’s medical symptoms).
2. F605 – This regulation still includes the previous requirement that the facility must ensure that the resident is free from chemical restraints. The definitions note that "Chemical restraint" refers to any drug used for discipline or that makes it more convenient (i.e., less effort) for staff to care for a resident, and not required to treat medical symptoms The SOM guidance clarifies that "Convenience" refers to the unnecessary administration of a medication that causes (intentionally or unintentionally) a change in a resident’s behavior (e.g., sedation) such that the resident is subdued and/or requires less effort from staff.
In addition, requirements related to psychotropic drugs (which are defined as any drug that affects brain activities associated with mental processes and behavior, including but not limited to, anti-psychotics, anti-depressants, anti-anxiety, and hypnotics) which were previously in effect at F758 have been added to F605.
a. The new requirements at F605 stated that, "Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any 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 reasons stated in paragraphs (d)(1) through (5) of this section.
b. F605 now also requires that, based on a comprehensive assessment of a resident, the facility must ensure that:
1. Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;
2. Residents who use psychotropic drugs receive gradual dose reductions (GDR), and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;
3. Residents do not receive psychotropic drugs pursuant to a PRN (as needed) order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record;
4. PRN orders for psychotropic drugs are limited to 14 days. Except as provided in §483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident’s medical record and indicate the duration for the PRN order; and
5. 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.
Psychotropic medications have the potential to create symptoms consistent with sedation, creating convenience for staff, which would be considered a chemical restraint. In order to keep residents free from chemical restraints used for discipline or convenience and that are not required to treat the resident’s medical symptoms, the facility must prevent the unnecessary use of psychotropic medications.
In conclusion, noncompliance with the requirements to keep residents free from chemical restraints and prevent the unnecessary use of psychotropic medications are now both cited at F605. A failure to meet one or more of the requirements listed above can result in a citation at this F-tag. The regulation requires that residents are not given any medications which are not adequately clinically indicated and necessary to treat a specific condition. The medical record must include documentation of the adequate clinical indication and necessity for prescribed psychotropic medications, as well as information on other areas including, but not limited to, informed consent, prior attempts at non-pharmacological interventions (unless clinically contraindicated), evidence of monitoring, and GDR attempts/response to pharmacy recommendations unless there is evidence of a clinical contraindication, such as previous failed attempts. The guidance in the SOM for F605 provides useful information about the documentation that surveyors will review, the observations to be made, and interviews to be conducted while reviewing this care area. Understanding the survey process and implementing the information detailed in the guidance for this regulation can assist the facility to avoid unnecessary deficiencies, and, at the same time, improve the quality of life and care for its residents.
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