CMS Federal Regulation F605 - Chemical Restraints/Unnecessary Psychotropic Medications

This post is designed to provide nursing home administrators with a clear and comprehensive understanding of CMS Federal Regulation F605, specifically addressing chemical restraints and the unnecessary use of psychotropic medications. This regulation has been revised to incorporate regulations and guidance for unnecessary use of psychotropics and to streamline survey processes. Compliance with this regulation is crucial for ensuring resident rights, safety, and quality of life. Understanding the key requirements and implementing proactive compliance measures are essential for avoiding deficiencies and promoting a resident-centered care environment. It is imperative to stay vigilant in identifying and avoiding the implementation of practices which may be deemed a chemical restraint.

I. Key Requirements of F605: Chemical Restraints/Unnecessary Psychotropic Medications

F605, under §483.10(e) Respect and Dignity, §483.12 Freedom from Abuse, Neglect, and Exploitation, and §483.45(c)(3), (d), and (e) Medication Regimen Review, focuses on the following key areas:

• Freedom from Restraints: Residents have the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident's medical symptoms (§483.10(e)(1), §483.12(a)(2)).

• Definition of Chemical Restraint: A chemical restraint is any medication used for discipline or convenience that is not required to treat the resident's medical symptoms. This includes medications that cause sedation or subdue the resident, making care easier for staff (even unintentionally) and medications to punish or penalize residents. This includes medications used to cause sedation to subdue residents or because the resident requires less effort from staff.

• Convenience: 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. Therefore, if a medication causes symptoms consistent with sedation (e.g., excessive sleeping, drowsiness, withdrawal, decreased activity), it may take less effort to meet a resident’s behavioral needs, which meets the definition of convenience.

• Discipline: Any action, such as the administration of a medication, taken by facility staff for the purpose of punishing or penalizing residents.

  • Example: A resident has been wandering into other resident’s rooms and staff administer a medication to restrict the resident to their room.

  • Example: Staff become upset with a resident who resists receiving a bath and pinches staff. The staff did not assess the resident’s needs or implement non-pharmacological interventions to address their resistance to bathing. Instead, staff administer medication to subdue the resident prior to providing the next bath.

• Definition of Psychotropic Drug: §483.45(c)(3) A psychotropic drug is 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-psychotic;

  • Anti-depressant;

  • Anti-anxiety; and

  • Hypnotic.

  • Other medications can be considered psychotropic medications when used as a substitution for another psychotropic medication or used to treat a mental health disorder instead of the original intent.

• Unnecessary Drugs: Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used (§483.45(d)):

  • In excessive dose (including duplicate drug therapy);

  • For excessive duration;

  • Without adequate monitoring;

  • Without adequate indications for its use;

  • In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or

  • Any combination of the reasons stated above.

• Psychotropic Drug Use Requirements: Based on a comprehensive assessment of a resident, the facility must ensure (§483.45(e)):

  • 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;

  • Residents who use psychotropic drugs receive gradual dose reductions (GDRs), and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;

  • Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and

  • PRN orders for psychotropic drugs are limited to 14 days. With limited exceptions, the attending physician or prescribing practitioner must document the rationale for extending a PRN order beyond 14 days. 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.

• Comprehensive Assessment & Non-Pharmacological Interventions: Facilities must evaluate a resident’s physical, behavioral, mental, and psychosocial signs and symptoms in order to identify and rule out any underlying medical conditions. Before initiating or continuing psychotropic medications, a comprehensive assessment must be conducted to identify underlying causes of behavior and to rule out any underlying medical conditions. Non-pharmacological approaches must be attempted, unless clinically contraindicated, to minimize the need for psychotropic medications, use the lowest possible dose, or discontinue the medications.

• Resident's Right to be Informed: The resident has the right to be fully informed of and participate in or refuse treatment, including the right to accept or decline the medication. Prior to initiating or increasing a psychotropic medication, the resident, family, and/or resident representative must be informed of the benefits, risks, and alternatives for the medication, including any black box warnings for antipsychotic medications, in advance of such initiation or increase.

• Dose and Duration: Dose and duration of medications should be based on the resident's diagnoses, signs and symptoms, current condition, age, coexisting medication regimen, review of lab results, and input from the IDT, including the resident's preferences and goals.

• Gradual Dose Reduction (GDR): The facility must show evidence that a GDR has been attempted unless clinically contraindicated. Within the first year a resident is admitted on a psychotropic medication or after the prescribing practitioner has initiated a psychotropic medication, the facility should attempt a GDR in two separate quarters, with at least one month between the attempts. Medical record documentation should reflect the date of the GDR attempt, the outcome of the dose reduction attempt, and the plan regarding future GDR attempts. Physician documentation should contain the rationale for why GDR attempts are clinically contraindicated for the resident. The MDS assessments should be accurate with the medical record on the dates for GDRs and/or clinical contraindications.

• Monitoring and Adverse Consequences: Monitoring and accurate documentation of the resident’s response to any treatment is essential to evaluate the ongoing effectiveness, benefits as well as risks of non-pharmacological approaches and psychotropic medications. The facility should have a system for monitoring residents for adverse effects of psychotropic medications (e.g., sedation, falls, cognitive decline).

II. Compliance Probes for the Administrator

To verify your facility's compliance with F605, consider these investigative probes:

• Policy & Procedure Review:

  • Does the facility have a written policy and procedure regarding the use of psychotropic medications and chemical restraints?

  • Does it clearly define chemical restraint, discipline, and convenience in the context of medication use?

  • Is there a process outlined for obtaining informed consent from residents or their representatives before initiating or changing psychotropic medications?

  • Are the policies and procedures regularly reviewed and updated based on current guidelines and best practices?

• Medication Regimen Review:

  • Is a comprehensive medication regimen review (MRR) conducted regularly by a qualified pharmacist? (See F756)

  • Does the MRR specifically address the appropriateness of psychotropic medication use, potential adverse effects, drug interactions, and opportunities for dose reduction or discontinuation?

  • Are irregularities identified during the MRR addressed promptly by the prescribing practitioner and documented in the resident's medical record?

  • Is there a process for reviewing all medications initiated in other settings (e.g., hospitals) to ensure ongoing appropriateness and clinical indication?

• Comprehensive Assessment:

  • Are comprehensive assessments conducted upon admission and with significant changes in condition, addressing physical, mental, psychosocial, and behavioral needs?

  • Is there documentation of efforts to identify and address underlying medical conditions or environmental factors contributing to behaviors before initiating psychotropic medications?

  • Is there clear and thorough documentation in the medical record to support the medical necessity for any psychotropic medication prescribed?

  • Are care plans developed collaboratively with the resident, their family, and the interdisciplinary team to address these needs using non-pharmacological interventions whenever possible?

  • Does the documentation include the resident’s, family's, and/or resident representative's preferences and goals?

• Non-Pharmacological Interventions:

  • Is there documentation of attempted non-pharmacological interventions and the rationale for their effectiveness or ineffectiveness prior to the initiation of psychotropic medications, unless clinically contraindicated?

  • Are these interventions individualized and tailored to the resident's specific needs and preferences?

  • Have staff been trained in non-pharmacological behavioral interventions?

  • Where clinical contraindication exists that non-pharmacological interventions cannot be attempted, is there clear documentation to support this?

• Gradual Dose Reduction (GDR):

  • Is there a system in place to ensure GDRs are attempted for residents on psychotropic medications, unless clinically contraindicated?

  • Does the program include regular evaluation of the resident's condition and medication effectiveness by the interdisciplinary team?

  • Is there clear documentation of the GDR attempts, outcomes, and rationale for continuation or discontinuation of the medication?

  • Is the clinical rationale for contraindications to GDR clearly documented by the physician?

  • Are the MDS assessments accurate with the medical record on the dates for GDRs and/or clinical contraindications?

• PRN Medication Orders:

  • Are PRN orders for psychotropic medications limited to 14 days, with appropriate physician documentation for extensions?

  • Is there clear documentation of the specific condition being treated with the PRN medication?

  • Are PRN orders reviewed regularly to assess their continued appropriateness?

  • Is there documentation that the resident’s symptoms have stabilized when evaluating if medications are still relevant?

  • Are PRN orders for antipsychotics reviewed by the prescribing practitioner within 14 days, and is there documentation of this review?

• Monitoring and Adverse Effects:

  • Is there a system for monitoring residents for adverse effects of psychotropic medications (e.g., sedation, falls, cognitive decline)?

  • Are these adverse effects promptly addressed and documented, with appropriate medication adjustments?

  • Does the facility regularly monitor and track the use of psychotropic medications?

  • Is there documentation if the medication has caused symptoms consistent with prolonged sedation?

  • Are incident reports filed and reviewed for any adverse events related to medication use, including potential chemical restraint situations?

• Informed Consent and Resident Rights:

  • Is there documentation that the resident (or representative) has been informed of the risks, benefits, and alternatives to psychotropic medications before initiation or dose changes?

  • Are residents and their families educated about their right to refuse psychotropic medications?

  • Is there evidence that the resident's preferences and goals are considered in the medication decision-making process?

  • Are residents actively involved in decisions about their medication regimens?

• Staff Training:

  • Have staff been trained on the appropriate use of psychotropic medications, the risks of chemical restraints, and non-pharmacological behavioral interventions?

• Documentation:

  • Is all documentation related to medication use and behavioral interventions clear, concise, and readily accessible in the resident's medical record?

• Quality Assurance and Performance Improvement (QAPI):

  • Are you using QAPI to monitor the use of psychotropic medications, identify trends, and implement corrective actions to improve resident outcomes?

• Medical Director Oversight:

  • Is the Medical Director actively involved in overseeing medication use and ensuring compliance with F605?

Conclusion:

Compliance with F605 is paramount to protecting resident rights and ensuring appropriate medication use in your facility. By understanding the key requirements and implementing these compliance probes, administrators can create a culture of resident-centered care and minimize the risk of deficiencies. Regular monitoring, ongoing staff training, and a commitment to quality improvement are essential for maintaining compliance and promoting the well-being of your residents.

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