Monitoring for Inappropriate Use of Antipsychotic Medications F428 – Drug Regimen Review Process F329 – Unnecessary Medications Margie Huguet, RN, MCS DHH Health Standards Section Long Term Care Supervisor

10 Steps to Eliminate Off-Label Antipsychotic Use 1. Establish A Leadership Team 2. Review CMS Survey Guidance to Understand Why and How 3. Analyze MDS CASPER Resident Level Quality Measure Report to Identify Target Population and Coding Errors 4. Triage: Review Why Each Resident is Receiving Antipsychotics and Take Care of Easy-to-Act-On Situations 5. Train Staff on Why and How to Reduce Antipsychotics 6. QI Closest to the Resident – Track and Trend and Care Plan 7. Engage Physicians, Prescribers, Consultant Pharmacist 8. Engage Families 9. Update your policies, procedures and forms 10. Sustain and Spread ©B&F Consulting

Objectives: 1. Discuss the Drug Regimen Review (DRR) process (F428) and its role in assisting NHs in monitoring the inappropriate use of antipsychotic medications.

Pharmacy Consultant F425- Pharmacy Services Consultant Pharmacist

F425 - Pharmacy Services in a Nursing Home  Overall Goal is to ensure safe and effective use of medications;  (b)Service Consultation  The Licensed pharmacist:  collaborates with facility leadership and staff to coordinate the services;  helps the facility identify, evaluate, and address/resolve pharmaceutical concerns and issues that affect resident care, medical care or quality of life. F425- Pharmacy Services

The pharmacist is responsible for:  Helping the facility obtain and maintain timely and appropriate pharmaceutical services that support residents’ healthcare needs, that are consistent with current standards of practice, and that meet state and federal requirements.  Participating on the ID Team to address and resolve medication-related needs or problems.  Developing procedures and guidance regarding when to contact a prescriber about a medication issue and/or adverse effects, including what information to gather before contacting the prescriber; F425- Pharmacy Services Consultant Pharmacist

Nursing

Safeguards against Med Issues  The physician providing and reviewing the orders and total program of care on admission and the prescriber reviewing at each visit;  The nurse reviewing medications when transmitting the orders to the pharmacy and/or prior to administering medications;  The interdisciplinary team reviewing the medications as part of the comprehensive assessment for the Resident Assessment Instrument (RAI) and/or care plan;  The pharmacist reviewing the prescriptions prior to dispensing; and  The pharmacist performing the medication regimen review at least monthly. F425- Pharmacy Services

F428 – Drug Regimen Review 1. The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist. 2. The pharmacist must report any irregularities to 1. the attending physician, and 2. the director of nursing, and  these reports must be acted upon F428- Drug Regimen Review

What is a Medication Regimen Review?  A thorough evaluation of the medication regimen of a resident,  with the goal of promoting positive outcomes and minimizing adverse consequences associated with medication.  The review includes  preventing, identifying, reporting, and resolving medication-related problems, medication errors, or other irregularities,  and collaborating with other members of the interdisciplinary team. F428- Drug Regimen Review

What is an irregularity?  Refers to any event  that is inconsistent with usual, proper, accepted, or right approaches to providing pharmaceutical services, or  that impedes or interferes with achieving the intended outcomes of those services. F428- Drug Regimen Review

True or False F428- Drug Regimen Review

Regulatory Language – F329 (I)Drug Regimen must be Free from Unnecessary Drugs Any drug when used: I. In excessive dose (including duplicative therapy); or II. For excessive duration ; or III. Without adequate monitoring ; or IV. Without adequate indication for its use; or V. In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or VI. Any combination of the reasons above. F329- Drug Regimen Free from Unnecessary Drugs

Identification of Irregularities The pharmacist’s review considers factors such as:  Whether the physician and staff have documented objective findings, diagnoses and/or symptom(s) to support indications for use ;  Whether the physician and staff have identified and acted upon, or should be notified about, the resident’s allergies and/or potential side effects and significant medication interactions (such as medication-medication, medication- food, medication-disease, medication-herbal interactions);  Whether the medication dose, frequency, route of administration, and duration are consistent with the resident’s condition, manufacturer’s recommendations, and applicable standards of practice; F428- Drug Regimen Review

Identification of Irregularities  Whether the physician and staff have documented progress towards, or maintenance of, the goal(s) for the medication therapy;  Whether the physician and staff have obtained and acted upon laboratory results, diagnostic studies, or other measurements (such as bowel function, intake and output) as applicable;  Whether medication errors exist or circumstances exist that make them likely to occur; and F428- Drug Regimen Review

Identification of Irregularities  possible medication-related causes of recent or persistent changes F428- Drug Regimen Review

Monitoring  The ongoing collection and analysis of information (such as observations and diagnostic test results) and comparison to baseline date in order to:  Ascertain the response to treatment and care ;  Detect complications /adverse consequences;  Support decisions about modifying, discontinuing, or continuing any interventions. F428- Drug Regimen Review

F329 - Antipsychotic Drugs 2. Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that:  (i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and  (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. F329- Drug Regimen Free from Unnecessary Drugs

GDR – Gradual Dose Reduction  Seeking an appropriate dose and duration and minimizing the risk of adverse consequences;  To find an optimal dose or discontinue dose ;  When clinical condition has improved/ stabilized,  When underlying causes of the original target symptoms have resolved, and/or  When non-pharmacological interventions, including behavioral interventions, have been effective F329- Drug Regimen Free from Unnecessary Drugs

GDR - for Antipsychotics  Within the 1 st year in which a resident is admitted on an antipsychotic medication or after the facility has initiated an antipsychotic medication,  the facility must attempt a GDR in two separate quarters (with at least one month between the attempts),  unless clinically contraindicated  After the first year, a GDR must be attempted annually,  unless clinically contraindicated F329- Drug Regimen Free from Unnecessary Drugs

GDR – Clinically Contraindicated  Continued use is in accordance with relevant current standards of practice and ;  physician documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or increase distressed behavior; or  target symptoms returned or worsened after the most recent attempt at a GDR F329- Drug Regimen Free from Unnecessary Drugs

If we don’t medicate what else can we do?  Non-pharmacological interventions are approaches to care that do not involve medications, generally directed towards stabilizing or improving a resident’s mental, physical or psychosocial well-being.  “Behavioral interventions” are individualized non- pharmacological approaches (including direct care and activities) that are provided as part of a supportive physical and psychosocial environment, and are directed toward preventing, relieving, and/or accommodating a resident’s distressed behavior. F329- Drug Regimen Free from Unnecessary Drugs

Surveyor Triggers- Possible Irregularity

Drug Regimen Review A form of Quality Assurance & Performance Improvement F428- Drug Regimen Review

Drug Regimen Review Findings  The pharmacist is expected to document either that no irregularity was identified or the nature of any identified irregularities.  The pharmacist is responsible for reporting any identified irregularities to the  attending physician and  director of nursing. F428- Drug Regimen Review

Drug Regimen Review Findings  Considered part of each resident’s clinical record.  Maintained within the facility and is readily available for review.  The ID team is encouraged to review the reports and to get the pharmacist’s input on resident problems and issues. F428- Drug Regimen Review

Response to Irregularities  The physician either accepts and acts upon the report and potential recommendations or  rejects all or some of the report and provides a brief explanation of why the recommendation is rejected, such as in a dated progress note. F428- Drug Regimen Review

DON addresses/documents actions taken for:  recommendations that do not require a physician intervention, such as one to monitor vital signs or weights F428- Drug Regimen Review

Think About It

Policy’s and Procedures  Do you have one? Is it consistent with current Standards of Practice?  AMDA Letter to Medical Directors – P&Ps that promote:  a process of person-centered care  learning the story behind each resident  evaluating the behavior changes and excluding potential medical causes of the behavioral symptoms  P&P should  direct the staff to identify resident specific needs, optimize choices, and promote consistent assignments  Foster education of staff to ensure understanding of dementia- related behavior as a form of communication  Use of non-pharmacological interventions to address behaviors  Address proper monitoring Sample Psychotropic Med P/P – Advancing Excellence Website – Under Physician Tools Step 9 Updating Policies, Procedures, and forms

Sample Form: Psychotropic Medication Tracking Tool AHCA/NCAL Quality Initiative – Antipsychotic Management Tool Step 9 Updating Policies, Procedures, and forms