unnecessary medications

1 2006

F329 Unnecessary Medications

Unnecessary Unnecessary MedicationsMedications

Guidance TrainingGuidance Training

42 CFR § 483.25(l)(1),(2)42 CFR § 483.25(l)(1),(2)

F329F329

2006 2


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?

2006 4


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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(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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(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

2006 9


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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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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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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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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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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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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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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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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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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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

2006 23


Medication ManagementMedication ManagementResident ChoiceResident Choice

Right to make informed choices about care

Physician and staff facilitate resident’s decisions

Safety of residents is considered

2006 24


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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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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Indications for Use of PRN Circumstances for use are evaluated

and defined Frequency of administration defined

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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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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

2006 31


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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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

2006 35


Medication ManagementMedication ManagementDurationDuration

Common considerations for appropriate duration:• Enduring condition• Time-limited condition • Facility stop order or prescriber’s order

2006 36


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

2006 37


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?

2006 38


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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Investigative ProtocolInvestigative Protocol

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Investigative ProtocolInvestigative Protocol

Components• Objectives• Use• Procedures

2006 46


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

2006 47


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

2006 48


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

2006 49


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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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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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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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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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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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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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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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

2006 59


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

2006 60


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

2006 61

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

2006 62


Additional InvestigationAdditional Investigation

Potential Tags for Additional Potential Tags for Additional InvestigationInvestigation

63 2006



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

2006 66


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

2006 67


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

2006 68


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

2006 69


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

2006 70


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

unnecessary medications

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