F 329 Unnecessary Medications: Geriatric Principles Meets Regulations Charles Crecelius MD PhD FACP CMD

F-tag 329 Unnecessary Medications Updated, consolidated Incorporates newest geriatric principles Written by CMS with advise of leading geriatricians, pharmacists, nurses Associated pharmacy tags F428 Medication Regiment Review Sets guidance for all – physicians, pharmacists, homes, surveyors

F 329 Unnecessary Meds Intent Meds clinically required to treat a condition Non-pharmacologic measures used Medication promotes highest well-being Avoid actual or potential negative outcome Negative outcome promptly found / treated Doesn’t empower surveyor to practice medicine - should investigate the basis for decisions and interventions

Key Definitions Adverse consequences & ADR Behavior interventions Distressed behavior Gradual dose reduction Monitoring Non-pharmacologic intervention Psychopharmacological medication

Basic Pharmacologic Principles Promote non-pharmacologic interventions Indication for use Select based on individual risk / benefit Appropriate dose / duration Avoid duplicative therapy Monitor efficacy & side effects Prevention, identification, and response to adverse consequences GDR (gradual dose reduction)

Non-pharmacologic Interventions Require: assessing and understanding causes for need of medication reduction/elimination of impediments, triggers and causes: Examples Modification of environment Modification/elimination of psychological stressors Accommodation of previous lifelong activities or roles Modification of staff/resident interactions Behavioral Interventions

Individual Risk & Benefit Distinct / unique review of needs & goals Informed choice Condition, options, risk / benefit, outcomes Effects refusing treatment Regular review Can’t refuse physician directed treatment to treat imminent danger Advance directives don’t preclude other treatment (no code is not no care)

Monitoring Criteria Identify essential information who collects, how recorded Determine frequency of monitoring Condition, risk ADR Define communication and analysis Interdisciplinary team, goal Re-evaluate & update plan Change meds/conditions/diet

When to Evaluate Medication for Benefit / Adverse Consequences Admit / readmit Clinically significant change in status New symptom / problem Worsening existing problem Unexpected decline function / cognition Non specific symptom without cause New med, review of med, med irregularity MMRR

Special Considerations New Admits Justify each med, consider ADR New med order as an emergency Address underlying cause Re-evaluate after acute phase over Psychiatric disorder or distressed behavior Appropriate diagnosis, seek cause Multiple prescribers

GDR All Medication Potential Candidates When condition stable or improved, causes target symptoms resolved, non-pharmacologic tx success Opportunities MMR Quarterly MDS Review Practitioner review Psychopharmacologic medication Review & document risk/benefit q 3 months

GDR Antipsychotics / non-anxiolytic/sedatives Sedatives / Hypnotics 1st year – 2 separate quarters, at least 1 month between Annually thereafter Unless clinically contraindicated Sedatives / Hypnotics If used more than 3 times a week Attempt taper at least quarterly, 3 out of 4 quarters

Medications of Particular Relevance to Long-Term Care Broad list of medications with potential concerns in the elderly & long term care Replaces revised “Beer’s list” Lists medication class, then specific names Ask to consider various factors Indication Dosage / duration Monitoring Adverse consequences Documentation Documentation proportional to degree risk/benefit

Surveyor Investigative Protocol Unnecessary Medications Non-compliance Inadequate indication for use Inadequate monitoring Excessive dose Excessive duration Adverse consequences Antipsychotic Absence of specific condition Without behavior intervention & GDR

Deficiency Categorization Examples Level 4 Immediate Jeopardy INR > 9 with failure to assess / act Failure to monitor INR without care plan, staff knowledge potential problems Failure to monitor or dose reduce for antipsychotic in presence of side effect Failure to do non-contraindicated GDR with resulting tardive dyskinesia while on prolonged antipsychotics Failure to recognize, assess or respond to meds that caused a GI bleed

Deficiency Categorization Examples Level 3 Actual Harm that is not Immediate Jeopardy INR 4-9 with failure to act with bleeding Failure to evaluate seizure as a result of other meds, adding potentially unneeded AED Failure to perform GDR resulting in continued antipsychotic use with decline, adverse effect

Deficiency Categorization Examples Level 2 No actual harm with potential for more than minimal harm INR 3.5-9 with failure to act and no bleeding Failure to monitor INR, prior stable INR, no bleeding Failure to identify med as cause of rash Failure to monitor potential med adverse effect (e.g. no TSH & on thyroid Rx)

Deficiency Categorization Examples Level 1 No actual harm with potential for minimal harm Failure to provide appropriate care & services to avoid unnecessary meds / minimize adverse outcomes place residents at risk for more than minimal harm No level 1 severity

The Medical Director & F329 Reducing Medication Related Problems Individualize approach depending on problematic areas facility Education of Staff & Attendings Improve systems which impact medication management Monitor performance & provide feedback

Educational Efforts for Staff Non-pharmacological Interventions Top offending medications GDR Requirements Monitoring tools / requirements Targeting frail / declining residents Common ADR (serotonin syndrome, EPS, TD, NMS anticholinergic side-effect)

Educational Efforts for Staff Signs, Symptoms & Conditions Possibly Associated w/ Medications Anorexia, unplanned weight loss or gain Behavioral changes, unusual behavior patterns Bleeding / bruising, spontaneous / unexplained Bowel dysfunction Dehydration, fluid/electrolyte imbalance Depression, mood disturbance Dysphagia, swallowing difficulty Falls, dizziness, impaired coordination

Educational Efforts for Staff Signs, Symptoms & Conditions Possibly Associated w/ Medications Gastrointestinal bleeding Headaches, muscle pain, general nonspecific aching or pain Mental status changes, (new, worsening, delirium) Rash, pruritus Respiratory difficulty or changes Sedation (excess), insomnia, disturbed sleep Seizure activity Urinary retention or incontinence

System Improvements Utilization Monitoring Tools Physiological, cognitive functional Vital signs Labs, EKGs, blood sugars, Hgb A1C RAI, FAST, IADL, PSMS MMSE, CAM, AIMS, FAST Mood/Affect (MDS / QI) GDS, Cornell DDS, Mania Rating Scale Behavior (MDS / QI) Behave AD, CMAI, NPI-NH

System Improvements Protime / INR Monitoring System-wide use coumadin flow sheets Pulled when labs drawn Sent to physician for fax adjustment or read to physician if called Contains default orders for common situations Set standard protime draw days CMT “signs off” new order Recap orders require check last protime

Auditing Medication Management Monitor Indication with Consulting Pharmacist Do target symptoms / causes warrant therapy Could non-Rx interventions be relevant Is a particular medication pertinent to managing symptoms or condition Is risk worth benefit If prn are circumstances for use clearly delineated

Auditing Medication Management Review GDR & Psychopharmacologics Triggered with new order; tickler system for old orders Special form of MRR using pharmacist & medical director Placed in front of order section Lists requirements of F329, offers tapering suggestions Results audited, presented to attendings

Always consider medication as a possible problem, and not just as the solution Any symptom in an elderly patient should be considered a drug side effect until proved otherwise (Gurwitz) A medication is a poison with a desirable side-effect (Osler)

Appendix F329 Unnecessary Medications Medications of Particular Interest in Long Term care

Medication Issues of Particular Relevance to Long-Term Care Analgesics Acetaminophen NSAIDs (Traditional, COX-2) Opioids (esp. meperidine) Pentazocine Propoxyphene (and combinations) Antibiotics (all) Vancomycin / aminoglycosides Nitrofuration Fluoroquinolones

Medication Issues of Particular Relevance to Long-Term Care Anticoagulants Warfarin Anticonvulsants All Seizure or mood stabalizer Antidepressants All (class listings) MAO inhibitors Tricyclics

Medication Issues of Particular Relevance to Long-Term Care Anti-diabetic Medication Metformin Glitazones Chlorpropamide & glyburide Antifungals Imidazoles Anti-manic medications Lithium

Medication Issues of Particular Relevance to Long-Term Care Anti-Parkinson medication (all) Antipsychotics Conventionals Atypicals Anxiolytics Short-acting benzodiazepines Long-acting benzodiazepines Buspirone Diphenhydramine / hydroxyzine Meprobamate

Medication Issues of Particular Relevance to Long-Term Care Cardiovascular medications Antiarrhythmics (amiodarone, disopyramide) Antihypertensives - All Methyldopa Digoxin Diuretics Nitrates

Medication Issues of Particular Relevance to Long-Term Care Cholesterol lowering medicines Statins cholestyramine Cognitive enhancers Cold, cough and allergy medication All H1 blockers Oral decongestants

Medication Issues of Particular Relevance to Long-Term Care Gastrointestinal medications GI antispasmotics Phenothiazines, trimethobenzamide Metoclopramide Proton pump inhibitors Glucocorticoids Hematinics Erythropoiesis stimulants Iron

Medication Issues of Particular Relevance to Long-Term Care Laxatives Muscle relaxants Orexigenics (appetite stimulants) Osteoporosis medications (biphosphonates) Platelet inhibitors Salicylates Ticlopidine Clopidogrel

Medication Issues of Particular Relevance to Long-Term Care Respiratory medication Theophylline Inhalants Sedative / hypnotics All Barbituates Thyroid medication OAB medication All

Medications with Significant Anticholinergic Properties Antihistamines Respiratory (ipratropium) GI drugs Tricyclic antideressants Trazedone Muscle relaxants Urinary antispasmodics Antiparkinson Antipsychotics