Transcript Psychosocial

F329 Unnecessary Medications
Unnecessary Medications
Guidance Training
42 CFR § 483.25(l)(1),(2)
F329
2006
1
F329 Unnecessary Medications
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
 Utilize the components of the investigative
protocol
 Identify compliance with the regulation
 Appropriately categorize the severity of
noncompliance
2006
2
F329 Unnecessary Medications
Discussion Question
What elements are
included in the care process?
2006
3
F329 Unnecessary Medications
Regulatory Language
CFR § 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
2006
4
F329 Unnecessary Medications
Regulatory Language
CFR § 483.25(l)(1) Unnecessary Medications
(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.
2006
5
F329 Unnecessary Medications
Regulatory Language
CFR § 483.25(l)(2) Unnecessary Medications
(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
2006
6
F329 Unnecessary Medications
Regulatory Language
CFR § 483.25(l)(2) Unnecessary Medications
(ii) Residents who use antipsychotic drugs
receive gradual dose reductions, and
behavioral interventions, unless clinically
contraindicated, in an effort to discontinue
these drugs.
2006
7
F329 Unnecessary Medications
Unnecessary Medications
Interpretive Guidelines
2006
8
F329 Unnecessary Medications
Unnecessary Medications
Components of the Interpretive Guidelines








2006
Intent
Definitions
Overview
Medication Management
Medication Tables
Investigative Protocol
Determination of Compliance
Deficiency Categorization
9
F329 Unnecessary Medications
Interpretive Guidelines
Intent
Medication Regimen is managed to:


Limit medications, doses and duration to clinically
indicated

Consider non-pharmacological interventions

Minimize adverse consequences

2006
Promote/maintain highest practicable well-being
Recognize condition change/decline, evaluate role of
medications and modify regimen if needed.
10
F329 Unnecessary Medications
Interpretive Guidelines
Definitions







2006
Adverse Consequences
Behavioral Interventions
Clinically Significant
Distressed Behavior
Indications for Use
Monitoring
Psychopharmacological Medication
11
F329 Unnecessary Medications
Interpretive Guidelines
Definitions
Adverse 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., medicationmedication, medication-food, and medicationdisease).
2006
12
F329 Unnecessary Medications
Interpretive Guidelines
Definitions
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.
2006
13
F329 Unnecessary Medications
Interpretive Guidelines
Definitions
Clinically 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.
2006
14
F329 Unnecessary Medications
Interpretive Guidelines
Definitions
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.
2006
15
F329 Unnecessary Medications
Interpretive Guidelines
Definitions
Indications 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.
2006
16
F329 Unnecessary Medications
Interpretive Guidelines
Definitions
Monitoring – is the ongoing collection and
analysis of information (such as observations
and diagnostic test results) and comparison
to baseline data in order to:



2006
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.
17
F329 Unnecessary Medications
Interpretive Guidelines
Definitions
Psychopharmacologic medications –
any medication used for managing behavior,
stabilizing mood, or treating psychiatric
disorders.
2006
18
F329 Unnecessary Medications
Interpretive Guidelines
Overview
Goals for Medication Use:

2006
Maintain or improve function and
wellbeing
19
F329 Unnecessary Medications
Interpretive Guidelines
Overview


2006
Non-pharmacological approaches require
assessing and understanding causes for need
of medication
Approaches involve reduction/elimination of
impediments, triggers and causes
20
F329 Unnecessary Medications
Interpretive Guidelines
Overview
Examples of Non-Pharmacological Interventions:


Modification of environment
Modification/elimination of psychological stressors



2006
Accommodation of previous lifelong activities or
roles
Modification of staff/resident interactions
Behavioral Interventions
21
F329 Unnecessary Medications
Interpretive Guidelines
Medication Management







2006
Resident Choice & Advance Directives
Indications for Use
Monitoring
Dose
Duration
Tapering/ Gradual Dose Reduction
Adverse Consequences
22
F329 Unnecessary Medications
Medication Management
Resident Choice



2006
Right to make informed choices about care
Physician and staff facilitate resident’s
decisions
Safety of residents is considered
23
F329 Unnecessary Medications
Medication Management
Advance Directives


2006
Care provided consistent with the resident’s
condition and care instructions
Do Not Resuscitate (DNR) refers only to
CPR
24
F329 Unnecessary Medications
Medication Management
Indications 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
2006
25
F329 Unnecessary Medications
Medication Management
Indications 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
2006
26
F329 Unnecessary Medications
Medication Management
Indications for Use of Medication
Indications for Use of PRN


2006
Circumstances for use are evaluated and
defined
Frequency of administration defined
27
F329 Unnecessary Medications
Medication Management
Indications for Use of Medication
What do these 5 circumstances have in common?





2006
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
28
F329 Unnecessary Medications
Medication Management
Monitoring for Efficacy & Adverse Consequences
Effective Monitoring:

Understand indications and goals for use

Identify baseline information/resident
condition

Understand characteristics of medication

Ongoing vigilance

Periodic re-evaluation
2006
29
F329 Unnecessary Medications
Medication Management
Monitoring for Efficacy & Adverse Consequences
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
30
F329 Unnecessary Medications
Medication Management
Monitoring 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
2006
31
F329 Unnecessary Medications
Medication Management
Monitoring for Efficacy & Adverse Consequences


2006
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
32
F329 Unnecessary Medications
Medication Management
Dose

Dose influenced by:




2006
Clinical response
Possible adverse consequences
Other resident- and medication-related variables
Route of administration
33
F329 Unnecessary Medications
Medication Management
Dose
•
•
Duplicate therapy generally not indicated
Examples of potentially problematic duplicate
therapy:



2006
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
34
F329 Unnecessary Medications
Medication Management
Duration
Common considerations for appropriate
duration:
•
•
•
2006
Enduring condition
Time-limited condition
Facility stop order or prescriber’s order
35
F329 Unnecessary Medications
Medication Management
Tapering 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
36
F329 Unnecessary Medications
Medication Management
Tapering and GDR (Cont’d)
When would the interdisciplinary team
evaluate the resident’s response to
medications and consider reduction or
discontinuation of medications?
2006
37
F329 Unnecessary Medications
Medication Management
Tapering and GDR (Cont’d)

Antipsychotics & Psychopharmacological

Attempt GDR during two separate quarters initially; then
attempt GDR annually

Contraindications to GDR:


Sedatives/Hypnotics

If used routinely, attempt GDR quarterly

Contraindications to GDR:

2006
Symptoms return or worsen
Physician documents rationale re: impaired function or
exacerbation of disorder
38
F329 Unnecessary Medications
Medication Management
Adverse Consequences
Increased Adverse Consequence Risk:
• Number of medications
• Certain pharmacological classes
2006
39
F329 Unnecessary Medications
Medication Management
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
2006
40
F329 Unnecessary Medications
Interpretive Guidelines
Table I: Medication Issues of Particular Relevance
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
2006
41
F329 Unnecessary Medications
Interpretive Guidelines
Table I: Medication Issues of Particular Relevance
Examples of Medications/groups of
Medications provided in Table I

Warfarin
Antipsychotics

Hypnotics

2006
42
F329 Unnecessary Medications
Interpretive Guidelines
Table II: Medications with Significant
Anticholinergic Properties
2006

Anticholinergic side effects are common

Medications in many categories have
anticholinergic properties

Use of multiple medications with
anticholinergic properties may be particularly
problematic
43
F329 Unnecessary Medications
Unnecessary Medications
Investigative Protocol
2006
44
F329 Unnecessary Medications
Investigative Protocol
Components
•
•
•
2006
Objectives
Use
Procedures
45
F329 Unnecessary Medications
Investigative Protocol
Objectives
To determine whether the resident receives:



2006
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
46
F329 Unnecessary Medications
Investigative Protocol
Objectives (Cont’d)
To determine if the facility and the prescriber:


2006
Monitor medication for effectiveness and
emergence of adverse consequences
Recognize, evaluate, followup on medication
related adverse consequences
47
F329 Unnecessary Medications
Investigative Protocol
Objectives (Cont’d)

To determine if the pharmacist:



2006
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
48
F329 Unnecessary Medications
Investigative Protocol
Use




Each sampled resident
Standard survey
Initial survey
As necessary for:


2006
Revisits
Abbreviated survey
49
F329 Unnecessary Medications
Investigative Protocol
Procedures
Investigation involves:


2006
Observation and record review
Interviews
50
F329 Unnecessary Medications
Investigative Protocol
Procedures
Observation and Record Review
The table in the Protocol describes:
2006

Medication related signs and symptoms

Expectations for review of all medications
51
F329 Unnecessary Medications
Investigative Protocol
Procedures
Interview resident and responsible party to determine:



2006
Participation in care planning and decision making
Consideration of non-pharmacological
interventions
Results/effectiveness of the medication therapy
and non-pharmacological approaches
52
F329 Unnecessary Medications
Investigative Protocol
Procedures
Interview knowledgeable staff to determine:

Impact of medication upon resident

Clinical rationale for medication


2006
Awareness that signs and symptoms may be adverse
consequences related to the medication regimen
Communication with attending physician to discuss
symptoms
53
F329 Unnecessary Medications
Investigative Protocol
Procedures
Interview knowledgeable staff to determine:



2006
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
54
F329 Unnecessary Medications
Investigative Protocol
Procedures
Interview physician to determine:



2006
Staff notification regarding medication-related issues
Assessment of the significance of medication-related
issues and concerns
Clinical rationale for management of resident’s
medications
55
F329 Unnecessary Medications
Investigative Protocol
Procedures
Medication Regimen Review – Determine:



2006
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
56
F329 Unnecessary Medications
Unnecessary Medications
Determination of Compliance
2006
57
F329 Unnecessary Medications
Determination of Compliance
Synopsis of Regulation
1. An adequate indication for use
2. Use of the appropriate dose
3. Provision of behavioral interventions and gradual
dose reduction, unless clinically contraindicated, for
those on antipsychotic medications
4. Use for the appropriate duration
5. 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
58
F329 Unnecessary Medications
Determination of Compliance
Criteria for Compliance
The facility is in compliance if they, along with
the prescriber:
•
•
•
•
2006
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
59
F329 Unnecessary Medications
Determination of Compliance
Criteria for Compliance
(Cont’d)
•
•
2006
Monitored for progress towards the
therapeutic goal(s) and emergence of
adverse consequences
Adjusted/discontinued dose in response to
adverse consequences
60
F329 Unnecessary Medications
Determination of Compliance
Noncompliance for F329
Aspects of the unnecessary medication requirement
leading to noncompliance:






2006
Inadequate indications for use including antipsychotics
Inadequate Monitoring
Excessive Dose
Excessive Duration
Adverse Consequences
Antipsychotic Medications without GDR and Behavioral
Interventions unless clinically contraindicated
61
F329 Unnecessary Medications
Additional Investigation
Potential Tags for Additional
Investigation
2006
62
F329 Unnecessary Medications
Unnecessary Medications
Deficiency Categorization
2006
63
F329 Unnecessary Medications
Deficiency Categorization
Components
• Severity determination
• Deficiency categorizations
•
2006
Levels 4 through 1
64
F329 Unnecessary Medications
Unnecessary Medications
Severity Determination
The key elements for severity determination are:



2006
Presence of harm or potential for negative outcomes
Degree of harm or potential harm related to
noncompliance
Immediacy of correction required
65
F329 Unnecessary Medications
Deficiency Categorization
Severity Determination Levels




2006
Level 4: Immediate Jeopardy to resident
health or safety
Level 3: Actual harm that is not immediate
jeopardy
Level 2: No actual harm with potential for
more than minimal harm that is not immediate
jeopardy
Level 1: No actual harm with potential for
minimal harm
66
F329 Unnecessary Medications
Deficiency Categorization
Severity Level 4: Immediate Jeopardy
Level 4: Immediate Jeopardy to resident
health or safety
 Noncompliance with one or more
requirements of participation:


2006
Has resulted in or is likely to result in serious
injury, harm, impairment, or death to a resident;
and
Requires immediate correction
67
F329 Unnecessary Medications
Deficiency Categorization
Severity Level 3: Actual Harm
Level 3: Actual harm that is not immediate
jeopardy


2006
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
68
F329 Unnecessary Medications
Deficiency Categorization
Severity Level 2: Potential for Harm

Level 2: No actual harm with potential for more than
minimal harm that is not immediate jeopardy
Noncompliance resulted in:


2006
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
69
F329 Unnecessary Medications
Deficiency Categorization
Severity Level 1: Potential for Minimal Harm
Level 1: No actual harm with potential for
minimal harm
 Noncompliance with F329 places resident at
risk for more than minimal harm

2006
Severity Level 1 does not apply for F329
70