Unnecessary Medications

1
Unnecessary Medications

• Guidance Training
• 42 CFR 483.25(l)(1),(2)
• F329

2
Training Objectives

• After todays 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

3
Discussion Question

• What elements are
• included in the care process?

4
Regulatory LanguageCFR 483.25(l)(1)
Unnecessary Medications

• (1) General. Each residents 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

5
Regulatory LanguageCFR 483.25(l)(1)
Unnecessary Medications

• (Contd)
• (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.

6
Regulatory LanguageCFR 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

7
Regulatory LanguageCFR 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.

8
Unnecessary Medications

• Interpretive Guidelines

9
Unnecessary Medications Components of the
Interpretive Guidelines

• Intent
• Definitions
• Overview
• Medication Management
• Medication Tables
• Investigative Protocol
• Determination of Compliance
• Deficiency Categorization

10
Interpretive GuidelinesIntent

• 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.

11
Interpretive GuidelinesDefinitions

• Adverse Consequences
• Behavioral Interventions
• Clinically Significant
• Distressed Behavior
• Indications for Use
• Monitoring
• Psychopharmacological Medication

12
Interpretive GuidelinesDefinitions

• Adverse consequence - is an unpleasant symptom
  or event that is due to or associated with a
  medication, such as impairment or decline in an
  individuals 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).

13
Interpretive GuidelinesDefinitions

• 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 residents
  distressed behavior.

14
Interpretive GuidelinesDefinitions

• Clinically significant refers to effects,
  results, or consequences that materially affect
  or are likely to affect an individuals 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.

15
Interpretive GuidelinesDefinitions

• 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.

16
Interpretive GuidelinesDefinitions

• Indications for use is the identified,
  documented clinical rationale for administering a
  medication that is based upon an assessment of
  the residents condition and therapeutic goals
  and is consistent with manufacturers
  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.

17
Interpretive GuidelinesDefinitions

• Monitoring 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 individuals 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.

18
Interpretive GuidelinesDefinitions

• Psychopharmacologic medications any medication
  used for managing behavior, stabilizing mood, or
  treating psychiatric disorders.

19
Interpretive GuidelinesOverview

• Goals for Medication Use
• Maintain or improve function and wellbeing

20
Interpretive GuidelinesOverview

• Non-pharmacological approaches require assessing
  and understanding causes for need of medication
• Approaches involve reduction/elimination of
  impediments, triggers and causes

21
Interpretive GuidelinesOverview

• 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

22
Examples of non-pharmacological interventions may
include

• Increasing the amount of resident exercise,
  intake of liquids and dietary fiber in
  conjunction with an individualized bowel regimen
  to prevent or reduce constipation and the use of
  medications (e.g. laxatives and stool softeners)
• Identifying, addressing, and eliminating or
  reducing underlying causes of distressed behavior
  such as boredom and pain
• Using sleep hygiene techniques and individualized
  sleep routines
• OHCA

23
Examples of non-pharmacological interventions may
include

• Individualizing toileting schedules to prevent
  incontinence and avoid the use of incontinence
  medications that may have significant adverse
  consequences (e.g., anticholinergic effects)
• Developing interventions that are specific to
  residents interests, abilities, strengths and
  needs, such as simplifying or segmenting tasks
  for a resident who has trouble following complex
  directions
• Accommodating the residents behavior and needs
  by supporting and encouraging activities
  reminiscent of lifelong work or activity
  patterns, such as providing early morning
  activity for a farmer used to awakening early
  OHCA

24
Examples of non-pharmacological interventions may
include

• Using massage, hot/warm or cold compresses to
  address a residents pain or discomfort or
• Enhancing the taste and presentation of food,
  assisting the resident to eat, addressing food
  preferences, and increasing finger foods and
  snacks for an individual with dementia, to
  improve appetite and avoid the unnecessary use of
  medications intended to stimulate appetite.
• OHCA

25
Interpretive GuidelinesMedication Management

• Resident Choice Advance Directives
• Indications for Use
• Monitoring
• Dose
• Duration
• Tapering/ Gradual Dose Reduction
• Adverse Consequences

26
Medication ManagementResident Choice

• Right to make informed choices about care
• Physician and staff facilitate residents
  decisions
• Safety of residents is considered

27
Medication Management Advance Directives

• Care provided consistent with the residents
  condition and care instructions
• Do Not Resuscitate (DNR) refers only to CPR

28
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

29
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

30
Medication Management Indications for Use of
Medication

• Indications for Use of PRN
• Circumstances for use are evaluated and defined
• Frequency of administration defined

31
Medication Management Indications 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

32
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

33
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

34
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

35
Medication Management Monitoring for Efficacy
Adverse Consequences

• Review Psychopharmacological and
  Sedative/Hypnotic medications quarterly
• Documentation must include
• Residents target symptoms and effect of
  medication
• Changes in residents function
• Medication-related side effects or adverse
  consequences

36
Medication ManagementDose

• Dose influenced by
• Clinical response
• Possible adverse consequences
• Other resident- and medication-related variables
• Route of administration

37
Medication Management Dose

• 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

38
Medication ManagementDuration

• Common considerations for appropriate duration
• Enduring condition
• Time-limited condition
• Facility stop order or prescribers order

39
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

40
Medication Management Tapering and GDR (Contd)

• When would the interdisciplinary team evaluate
  the residents response to medications and
  consider reduction or discontinuation of
  medications?

41
Medication Management Tapering and GDR (Contd)

• 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

42
Medication ManagementAdverse Consequences

• Increased Adverse Consequence Risk
• Number of medications
• Certain pharmacological classes
• anticoagulants, diuretics, antipsychotics,
  anti-infectives, and anticonvulsants.
• Tables I and II - classes of medications that
  are associated with frequent or severe adverse
  consequences
• OHCA add
  last 2 bullets

43
Medication ManagementAdverse Consequences
(Contd)

• 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

44
Interpretive GuidelinesTable 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

45
Interpretive GuidelinesTable I Medication
Issues of Particular Relevance

• Examples of Medications/groups of Medications
  provided in Table I
• Warfarin
• Antipsychotics
• Hypnotics

46
Interpretive GuidelinesTable II Medications
with Significant Anticholinergic Properties

• Anticholinergic side effects are common
• Medications in many categories have
  anticholinergic properties
• Use of multiple medications with anticholinergic
  properties may be particularly problematic

47
Unnecessary Medications

• Investigative Protocol

48
Investigative Protocol

• Components
• Objectives
• Use
• Procedures

49
Investigative ProtocolObjectives

• To determine whether the resident receives
• Only medications clinically indicated in the dose
  and duration to meet the residents needs
• Non-pharmacological interventions when clinically
  indicated
• GDR attempts for antipsychotics unless clinically
  contraindicated and tapering for other medications

50
Investigative ProtocolObjectives (Contd)

• 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

51
Investigative ProtocolObjectives (Contd)

• 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

52
Investigative ProtocolUse

• Each sampled resident
• Standard survey
• Initial survey
• As necessary for
• Revisits
• Abbreviated survey

53
Investigative ProtocolProcedures

• Investigation involves
• Observation and record review
• Interviews

54
Investigative ProtocolProcedures

• Observation and Record Review
• The table in the Protocol describes
• Medication related signs and symptoms
• Expectations for review of all medications

55
Investigative ProtocolProcedures

• 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

56
Investigative ProtocolProcedures

• 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

57
Investigative ProtocolProcedures

• 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

58
Investigative ProtocolProcedures

• 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 residents
  medications

59
Investigative ProtocolProcedures

• 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

60
Unnecessary Medications

• Determination of Compliance

61
Determination of Compliance

• Synopsis of Regulation
• An adequate indication for use
• Use of the appropriate dose
• Provision of behavioral interventions and gradual
  dose reduction, unless clinically
  contraindicated, for those on antipsychotic
  medications
• Use for the appropriate duration
• Monitoring to determine progress towards goals
  and emergence of adverse consequences
• Reduction of dose or discontinuation of
  medication in presence of adverse consequences

62
Determination of 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

63
Determination of ComplianceCriteria for
Compliance

• (Contd)
• Monitored for progress towards the therapeutic
  goal(s) and emergence of adverse consequences
• Adjusted/discontinued dose in response to adverse
  consequences

64
Determination of ComplianceNoncompliance 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

65
Additional Investigation

• Potential Tags for Additional Investigation

66
Unnecessary Medications

• Deficiency Categorization

67
Deficiency Categorization

• Components
• Severity determination
• Deficiency categorizations
• Levels 4 through 1

68
Unnecessary MedicationsSeverity 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

69
Deficiency CategorizationSeverity Determination
Levels

• 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

70
Deficiency CategorizationSeverity Level 4
Immediate Jeopardy

• Level 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

71
Deficiency CategorizationSeverity Level 3
Actual Harm

• Level 3 Actual harm that is not immediate
  jeopardy
• Noncompliance resulted in actual harm
• May include clinical compromise, decline, or
  residents inability to maintain and/or reach
  his/her highest practicable level of well-being

72
Deficiency CategorizationSeverity 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
• No more than minimal discomfort to resident
  and/or
• Has potential to compromise residents ability to
  maintain or reach his/her highest practicable
  level of well-being

73
Deficiency CategorizationSeverity 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
• Severity Level 1 does not apply for F329