We initially reviewed F757 Drug Regimen is Free from Unnecessary Drugs back in 2021, when the Ftag only included regulatory requirements without any real guidance. F757 was revised to only address unnecessary drugs/medications which are not psychotropics, since the psychotropic-specific guidance was incorporated into F605 Free from Chemical Restraints. The remaining requirements have not changed, but there is reorganized guidance to provide more clarity to this regulation. The reorganization included adding definitions to the regulation, which we’ll review first.
Definitions
Several definitions which were already in Appendix PP are making their way around the different regulations, so they appear in several places (including F605, which we’ll review soon in an Ftag of the Week).
“Adequate indication for use” is defined as the identified, documented clinical rationale for use of a medication that is based on the resident assessment, specifically, the resident’s condition and therapeutic goals. Any treatments which could be “safer” than administration of a medication must have been deemed clinically contraindicated as well.
An essential part of this definition is this: adequate indication for use means that the medication ordered and administered is consistent with manufacturer’s recommendations and/or clinical practice guidelines, clinical standards of practice, medication references, clinical studies or evidence-based reviews which have been published in medical/ pharmacy journals.
“Adverse consequence” refers to effects that a drug may have which are dangerous, unintended or unwanted. These effects may impair or cause a decline in a resident’s mental condition, physical condition, functional status or psychosocial status. Adverse drug reactions (ADRs) are a form of adverse consequences and include different types of drug reactions and interactions. Per Appendix PP, “adverse drug reaction” is often used interchangeably with “side effect,” but this is not technically accurate since a side effect is only one of the five categories of ADRs.
“Anticholinergic side effect” is the effect that medications such as antihistamines, antidepressants, antipsychotics, antiemetics, muscle relaxants and certain drugs used to treat Parkinson’s, urinary incontinence, GI issues, cardiovascular conditions or vertigo may cause. The medication inhibits or opposes parasympathetic nervous system activity to such a degree that it causes symptoms such as confusion, delirium, hallucinations, increased blood pressure, tachycardia, dry mouth, blurred vision, constipation and/or urinary retention.
“Serotonin Syndrome” results from overstimulation of serotonin receptors and is commonly related to the use of multiple serotonin-inducing medications concurrently. Symptoms vary and can include restlessness, hallucinations, confusion, loss of coordination, overactive reflexes, rapid changes in blood pressure, fast heartbeat, increased body temperature, nausea/ vomiting and/or diarrhea. Serotonin Syndrome can be a potentially serious clinical condition.
“Neuroleptic Malignant Syndrome (NMS)” is a syndrome which typically presents with a sudden onset of diffuse muscle rigidity, high fever, tremor, labile blood pressure and notable cognitive dysfunction. It is related to the use of medications and can be potentially fatal if not treated immediately. This includes stopping the medications which the syndrome is resulting from.
F757 – Intent & Guidance Overview
The revised Appendix PP includes the intent for F757, which is to ensure that each resident’s medication regimen is managed and monitored to promote or maintain the resident’s highest practicable mental/physical/psychosocial well-being.
The Interpretive Guidance (IG) indicates that medications are an integral part of the care that’s provided in nursing homes and there are several areas of guidance which have been added to this regulation. These include:
- Right to be Informed (F552)
- Comprehensive Assessment
- Necessity of Use Determination
- Dose and Duration
- Monitoring and Adverse Consequences
You can view our February 23, 2018 CMSCG “Ftag of the Week” for F552 Right to be Informed/ Make Treatment Decisions here since the regulatory requirements were not revised for F552. What’s important to be aware of is that the resident’s right to be informed is something that is highly emphasized as part of the revised SOM Appendix PP, particularly as it relates to medications. When we conduct mock surveys or other services where we’re reviewing a medical record, it’s not always possible to validate that informed consent was received prior to the initiation, change or discontinuation of a medication or treatment. Remember – the resident (and/or representative, as appropriate) is supposed to be a key member of the IDT.
In the next part of this Ftag guidance series, we’ll review more of the revised guidance as it relates to the comprehensive assessment and some other key parts of F757.
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