unnecessary medications
DESCRIPTION
Unnecessary Medications. Guidance Training 42 CFR § 483.25(l)(1),(2) F329. Training Objectives. After today’s session, you should be able to: Describe the intent of the regulation Explain the various medication management considerations required by the regulations - PowerPoint PPT PresentationTRANSCRIPT
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Unnecessary Unnecessary MedicationsMedications
Guidance TrainingGuidance Training
42 CFR § 483.25(l)(1),(2)42 CFR § 483.25(l)(1),(2)
F329F329
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Training ObjectivesTraining ObjectivesAfter today’s session, you should be able to: Describe the intent of the regulation Explain the various medication
management considerations required by the regulations
Utilize the components of the investigative protocol
Identify compliance with the regulation Appropriately categorize the severity of
noncompliance
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Discussion QuestionDiscussion Question
What elements are What elements are
included in the care process?included in the care process?
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Regulatory LanguageRegulatory LanguageCFR § 483.25(l)(1) Unnecessary MedicationsCFR § 483.25(l)(1) Unnecessary Medications
(1) General. Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used:
(i) In excessive dose (including duplicate drug therapy); or
(ii) For excessive duration; or (iii) Without adequate monitoring; or
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Regulatory LanguageRegulatory LanguageCFR § 483.25(l)(1) Unnecessary CFR § 483.25(l)(1) Unnecessary MedicationsMedications
(Cont’d)
(iv) Without adequate indications for its use; or
(v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
(vi) Any combinations of the reasons above.
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Regulatory LanguageRegulatory LanguageCFR § 483.25(l)(2) Unnecessary CFR § 483.25(l)(2) Unnecessary MedicationsMedications
(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
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Regulatory LanguageRegulatory LanguageCFR § 483.25(l)(2) Unnecessary CFR § 483.25(l)(2) Unnecessary MedicationsMedications
(ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.
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Unnecessary MedicationsUnnecessary Medications
Interpretive GuidelinesInterpretive Guidelines
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Intent Definitions Overview Medication Management Medication Tables Investigative Protocol Determination of Compliance Deficiency Categorization
Unnecessary MedicationsUnnecessary Medications Components of the Interpretive Components of the Interpretive Guidelines Guidelines
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Interpretive GuidelinesInterpretive GuidelinesIntentIntent
Medication Regimen is managed to: Promote/maintain highest practicable well-
being Limit medications, doses and duration to
clinically indicated Consider non-pharmacological interventions Minimize adverse consequences Recognize condition change/decline, evaluate
role of medications and modify regimen if needed.
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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
Adverse Consequences Behavioral Interventions Clinically Significant Distressed Behavior Indications for Use Monitoring Psychopharmacological Medication
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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
Adverse consequenceAdverse consequence - is an unpleasant symptom or event that is due to or associated with a medication, such as impairment or decline in an individual’s mental or physical condition or functional or psychosocial status. It may include various types of adverse drug reactions and interactions (e.g., medication-medication, medication-food, and medication-disease).
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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
Behavioral Interventions –Behavioral Interventions – 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.
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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
Clinically significantClinically significant – refers to effects, results, or consequences that materially affect or are likely to affect an individual’s mental, physical, or psychosocial well-being either positively by preventing, stabilizing, or improving a condition or reducing a risk, or negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in status.
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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
Distressed behavior - is behavior that reflects individual discomfort or emotional strain. It may present as crying, apathetic or withdrawn behavior, or as verbal or physical actions such as: pacing, cursing, hitting, kicking, pushing, scratching, tearing things, or grabbing others.
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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
Indications for useIndications for use – is the identified, documented clinical rationale for administering a medication that is based upon an assessment of the resident’s condition and therapeutic goals and is consistent with manufacturer’s recommendations and/or clinical practice guidelines, clinical standards of practice, medication references, clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals.
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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
MonitoringMonitoring – is the ongoing collection and analysis of information (such as observations and diagnostic test results) and comparison to baseline data in order to: Ascertain the individual’s response to treatment
and care, including progress or lack of progress toward a therapeutic goal;
Detect any complications or adverse consequences of the condition or of the treatments; and
Support decisions about modifying, discontinuing, or continuing any interventions.
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Interpretive GuidelinesInterpretive GuidelinesDefinitionsDefinitions
Psychopharmacologic medicationsPsychopharmacologic medications – any medication used for managing behavior, stabilizing mood, or treating psychiatric disorders.
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Interpretive GuidelinesInterpretive GuidelinesOverview Overview
Goals for Medication Use:Goals for Medication Use: Maintain or improve function and
wellbeing
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Interpretive GuidelinesInterpretive GuidelinesOverview Overview
Non-pharmacological approaches require assessing and understanding causes for need of medication
Approaches involve reduction/elimination of impediments, triggers and causes
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Interpretive GuidelinesInterpretive GuidelinesOverview Overview
Examples of Non-Pharmacological Interventions:
Modification of environment Modification/elimination of psychological
stressors Accommodation of previous lifelong activities
or roles Modification of staff/resident interactions Behavioral Interventions
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Interpretive GuidelinesInterpretive GuidelinesMedication ManagementMedication Management
Resident Choice & Advance Directives Indications for Use Monitoring Dose Duration Tapering/ Gradual Dose Reduction Adverse Consequences
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Medication ManagementMedication ManagementResident ChoiceResident Choice
Right to make informed choices about care
Physician and staff facilitate resident’s decisions
Safety of residents is considered
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Medication Management Medication Management Advance DirectivesAdvance Directives
Care provided consistent with the resident’s condition and care instructions
Do Not Resuscitate (DNR) refers only to CPR
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Medication Management Medication Management Indications for Use of MedicationIndications for Use of Medication
Indications require evaluation of information such as:
Comorbid conditions, signs, and symptoms Goals and preferences Allergies, potential interactions Past and current medications and
interventions Recognition of need for end-of-life or palliative
care Refusal of care and treatment Assessment instruments and diagnostic tools
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Medication Management Medication Management Indications for Use of MedicationIndications for Use of Medication
Analysis is used to: Rule out other causes of symptoms Identify whether signs/symptoms are
significant/persistent to warrant medication
Determine if the medication addresses symptom/condition
Identify whether the benefits outweigh risks
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Medication Management Medication Management Indications for Use of MedicationIndications for Use of Medication
Indications for Use of PRN Circumstances for use are evaluated
and defined Frequency of administration defined
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Medication Management Medication Management Indications for Use of MedicationIndications for Use of Medication
What do these 5 circumstances have in common?
A clinically significant change in condition/status
A new or recurrent clinically significant symptom
A worsening of an existing problem or condition
An unexplained decline in function or cognition Psychiatric disorders or distressed behavior
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Medication ManagementMedication Management Monitoring for Efficacy & Adverse Monitoring for Efficacy & Adverse ConsequencesConsequences
Effective Monitoring: Understand indications and goals for
use Identify baseline information/resident
condition Understand characteristics of
medication Ongoing vigilance Periodic re-evaluation
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Medication ManagementMedication Management Monitoring for Efficacy & Adverse Monitoring for Efficacy & Adverse ConsequencesConsequences
Steps in Monitoring Identify information and how it will be
obtained and reported Determine frequency Define method to communicate,
analyze and act Re-evaluate and updating approaches
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Medication Management Medication Management Monitoring for Efficacy & Adverse ConsequencesMonitoring for Efficacy & Adverse Consequences
Sources may help to define monitoring criteria:
• Manufacturers’ package inserts, black-box warnings
• Facility policies and procedures• Pharmacists• Clinical guidelines or standards of practice• Medication references• Published clinical studies or articles
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Medication ManagementMedication Management Monitoring for Efficacy & Adverse Monitoring for Efficacy & Adverse ConsequencesConsequences
Review Psychopharmacological and Sedative/Hypnotic medications quarterly
Documentation must include: Resident’s target symptoms and
effect of medication Changes in resident’s function Medication-related side effects or
adverse consequences
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Medication ManagementMedication ManagementDoseDose
Dose influenced by: Clinical response Possible adverse consequences Other resident- and medication-related
variables Route of administration
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Medication ManagementMedication Management DoseDose
• Duplicate therapy generally not indicated• Examples of potentially problematic
duplicate therapy: Use of more than one product containing
same medication Concomitant use of multiple benzodiazepines Use of medications from different therapeutic
categories that have similar effects/properties
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Medication ManagementMedication ManagementDurationDuration
Common considerations for appropriate duration:• Enduring condition• Time-limited condition • Facility stop order or prescriber’s order
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Medication ManagementMedication Management Tapering and GDRTapering and GDR
Goals of tapering or Gradual Dose Reduction (GDR):• Use lowest effective dose• Discontinue medication that no longer
benefits the resident• Minimize exposure to increased risk
of adverse consequences
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Medication ManagementMedication Management Tapering and GDR (Cont’d)Tapering and GDR (Cont’d)
When would the interdisciplinary When would the interdisciplinary team evaluate the resident’s team evaluate the resident’s response to medications and response to medications and
consider reduction or consider reduction or discontinuation of medications?discontinuation of medications?
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Medication ManagementMedication Management Tapering and GDR (Cont’d)Tapering and GDR (Cont’d)
Antipsychotics & Psychopharmacological Attempt GDR during two separate quarters initially;
then attempt GDR annually
Contraindications to GDR: Symptoms return or worsen
Sedatives/Hypnotics If used routinely, attempt GDR quarterly
Contraindications to GDR: Physician documents rationale re: impaired function or
exacerbation of disorder
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Medication ManagementMedication ManagementAdverse ConsequencesAdverse Consequences
Increased Adverse Consequence Risk:• Number of medications• Certain pharmacological classes
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Medication ManagementMedication ManagementAdverse Consequences (Cont’d)Adverse Consequences (Cont’d)
Delirium Common medication-related adverse
consequence Individuals who have dementia may
be at greater risk for delirium Delirium is associated with higher
morbidity and mortality
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Interpretive GuidelinesInterpretive GuidelinesTable I: Medication Issues of Particular Table I: Medication Issues of Particular RelevanceRelevance
Examples of categories of medications that:• Have potential to cause clinically
significant adverse consequences• Have limited indications for use• Require precautions in selection or
use• Require specific monitoring
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Interpretive GuidelinesInterpretive GuidelinesTable I: Medication Issues of Particular Table I: Medication Issues of Particular RelevanceRelevance
Examples of Medications/groups of Medications provided in Table I Warfarin Antipsychotics Hypnotics
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Interpretive GuidelinesInterpretive GuidelinesTable II: Medications with Significant Table II: Medications with Significant Anticholinergic PropertiesAnticholinergic Properties
Anticholinergic side effects are common
Medications in many categories have anticholinergic properties
Use of multiple medications with anticholinergic properties may be particularly problematic
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Unnecessary MedicationsUnnecessary Medications
Investigative ProtocolInvestigative Protocol
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Investigative ProtocolInvestigative Protocol
Components• Objectives• Use• Procedures
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Investigative ProtocolInvestigative ProtocolObjectivesObjectives
To determine whether the resident receives:
Only medications clinically indicated in the dose and duration to meet the resident’s needs
Non-pharmacological interventions when clinically indicated
GDR attempts for antipsychotics unless clinically contraindicated and tapering for other medications
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Investigative ProtocolInvestigative ProtocolObjectives (Cont’d)Objectives (Cont’d)
To determine if the facility and the prescriber:
Monitor medication for effectiveness and emergence of adverse consequences
Recognize, evaluate, followup on medication related adverse consequences
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Investigative ProtocolInvestigative ProtocolObjectives (Cont’d)Objectives (Cont’d)
To determine if the pharmacist:
Performed MRR monthly and identified existing irregularities
Reported any identified irregularities to attending physician and DON
To determine whether facility and/or practitioner acted upon report of irregularity
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Investigative ProtocolInvestigative ProtocolUseUse
Each sampled resident Standard survey Initial survey As necessary for:
Revisits Abbreviated survey
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Investigative ProtocolInvestigative ProtocolProceduresProcedures
Investigation involves: Observation and record review Interviews
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Investigative ProtocolInvestigative ProtocolProceduresProcedures
Observation and Record Review
The table in the Protocol describes:
Medication related signs and symptoms
Expectations for review of all medications
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Investigative ProtocolInvestigative ProtocolProceduresProcedures
Interview resident and responsible party to determine:
Participation in care planning and decision making
Consideration of non-pharmacological interventions
Results/effectiveness of the medication therapy and non-pharmacological approaches
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Investigative ProtocolInvestigative ProtocolProceduresProcedures
Interview knowledgeable staff to determine:
Impact of medication upon resident
Clinical rationale for medication
Awareness that signs and symptoms may be adverse consequences related to the medication regimen
Communication with attending physician to discuss symptoms
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Investigative ProtocolInvestigative ProtocolProceduresProcedures
Interview knowledgeable staff to determine:
Physician response to notification of suspected adverse medication consequences
MRR identification of related signs and symptoms of suspected adverse medication consequences
Staff notification of pharmacist
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Investigative ProtocolInvestigative ProtocolProceduresProcedures
Interview physician to determine:
Staff notification regarding medication-related issues
Assessment of the significance of medication-related issues and concerns
Clinical rationale for management of resident’s medications
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Investigative ProtocolInvestigative ProtocolProceduresProcedures
Medication Regimen Review – Determine:
Whether the pharmacist reported any irregularities with the medication regimen
Whether the attending physician or DON acted on identified irregularities
Whether the pharmacist identified a suspected adverse consequence to which the attending physician did not respond, but the staff followed up
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Unnecessary MedicationsUnnecessary Medications
Determination of Determination of ComplianceCompliance
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Determination of ComplianceDetermination of Compliance
Synopsis of Regulation Synopsis of Regulation 1. An adequate indication for use2. Use of the appropriate dose3. Provision of behavioral interventions and gradual
dose reduction, unless clinically contraindicated, for those on antipsychotic medications
4. Use for the appropriate duration5. Monitoring to determine progress towards goals
and emergence of adverse consequences 6. Reduction of dose or discontinuation of
medication in presence of adverse consequences
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Determination of ComplianceDetermination of ComplianceCriteria for ComplianceCriteria for Compliance
The facility is in compliance if they, along with the prescriber:• Assessed the resident• Determined that medication therapy was
indicated and identified the therapeutic goals• Utilized appropriate doses and duration• Implemented GDR and behavioral
interventions, unless clinically contraindicated, for residents receiving antipsychotic medications
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Determination of ComplianceDetermination of ComplianceCriteria for ComplianceCriteria for Compliance
(Cont’d)• Monitored for progress towards the
therapeutic goal(s) and emergence of adverse consequences
• Adjusted/discontinued dose in response to adverse consequences
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F329 Unnecessary MedicationsDetermination of Determination of ComplianceComplianceNoncompliance for F329Noncompliance for F329
Aspects of the unnecessary medication requirement leading to noncompliance:
Inadequate indications for use including antipsychotics
Inadequate Monitoring Excessive Dose Excessive Duration Adverse Consequences Antipsychotic Medications without GDR and
Behavioral Interventions unless clinically contraindicated
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Additional InvestigationAdditional Investigation
Potential Tags for Additional Potential Tags for Additional InvestigationInvestigation
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Unnecessary MedicationsUnnecessary Medications
Deficiency CategorizationDeficiency Categorization
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Deficiency CategorizationDeficiency Categorization
Components• Severity determination• Deficiency categorizations
• Levels 4 through 1
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Unnecessary MedicationsUnnecessary MedicationsSeverity DeterminationSeverity Determination
The key elements for severity determination are: Presence of harm or potential for negative
outcomes Degree of harm or potential harm related to
noncompliance Immediacy of correction required
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Deficiency CategorizationDeficiency CategorizationSeverity Determination LevelsSeverity Determination Levels
Level 4Level 4: Immediate Jeopardy to resident health or safety
Level 3Level 3: Actual harm that is not immediate jeopardy
Level 2Level 2: No actual harm with potential for more than minimal harm that is not immediate jeopardy
Level 1Level 1: No actual harm with potential for minimal harm
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Deficiency CategorizationDeficiency CategorizationSeverity Level 4: Immediate Severity Level 4: Immediate JeopardyJeopardy
Level 4Level 4: Immediate Jeopardy to resident health or safety
Noncompliance with one or more requirements of participation: Has resulted in or is likely to result in
serious injury, harm, impairment, or death to a resident; and
Requires immediate correction
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Deficiency CategorizationDeficiency CategorizationSeverity Level 3: Actual HarmSeverity Level 3: Actual Harm
Level 3Level 3: Actual harm that is not immediate jeopardy
Noncompliance resulted in actual harm
May include clinical compromise, decline, or resident’s inability to maintain and/or reach his/her highest practicable level of well-being
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Deficiency CategorizationDeficiency CategorizationSeverity Level 2: Potential for HarmSeverity Level 2: Potential for Harm
Level 2Level 2: No actual harm with potential for more than minimal harm that is not immediate jeopardy
Noncompliance resulted in: No more than minimal discomfort to resident; and/or Has potential to compromise resident’s ability to
maintain or reach his/her highest practicable level of well-being
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Deficiency CategorizationDeficiency CategorizationSeverity Level 1: Potential for Minimal Severity Level 1: Potential for Minimal HarmHarm
Level 1Level 1: No actual harm with potential for minimal harm
Noncompliance with F329 places resident at risk for more than minimal harm
Severity Level 1 does not apply for F329