Task 5 Information Gathering

1
Task 5 Information Gathering
2
Task 5 Information Gathering

• Title Change Subtask 5E - Medication Pass and
  Pharmacy Services
• Text added for assessment of pharmaceutical
  services

3
Task 5 Information Gathering

• Sub-Task 5A Text revised
• Each surveyor completing a medication pass
  observation will review drug storage on their
  assigned units

4
Task 5 Information Gathering

• Sub-Task 5C Revision
• Text added to use the Investigative Protocol for
  F329 for each Resident Review
• Deleted Adverse Drug Reactions Section 5C, part
  G3
• Resident Review form instruction to record all
  meds in past 7 days remains the same

5
Task 5 Information Gathering

• Title Change Subtask 5E - Medication Pass and
  Pharmacy Services
• Current guidance is entirely replaced
• Medication Pass (includes Labeling)

6
Unnecessary Medications

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

7
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

8
Discussion Question

• What elements are
• included in the care process?

9
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

10
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.

11
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

12
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.

13
Unnecessary Medications

• Interpretive Guidelines

14
Unnecessary Medications Components of the
Interpretive Guidelines

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

15
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.

16
Interpretive GuidelinesDefinitions

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

17
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).

18
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.

19
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.

20
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.

21
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.

22
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.

23
Interpretive GuidelinesDefinitions

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

24
Interpretive GuidelinesOverview

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

25
Interpretive GuidelinesOverview

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

26
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

27
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

28
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

29
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

30
Interpretive GuidelinesMedication Management

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

31
Medication ManagementResident Choice

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

32
Medication Management Advance Directives

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

33
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

34
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

35
Medication Management Indications for Use of
Medication

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

36
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

37
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

38
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

39
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

40
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

41
Medication ManagementDose

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

42
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

43
Medication ManagementDuration

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

44
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

45
Medication Management Tapering and GDR (Contd)

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

46
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

47
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

48
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

49
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

50
Interpretive GuidelinesTable I Medication
Issues of Particular Relevance

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

51
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

52
Unnecessary Medications

• Investigative Protocol

53
Investigative Protocol

• Components
• Objectives
• Use
• Procedures

54
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

55
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

56
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

57
Investigative ProtocolUse

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

58
Investigative ProtocolProcedures

• Investigation involves
• Observation and record review
• Interviews

59
Investigative ProtocolProcedures

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

60
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

61
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

62
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

63
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

64
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

65
Unnecessary Medications

• Determination of Compliance

66
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

67
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

68
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

69
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

70
Additional Investigation

• Potential Tags for Additional Investigation

71
Unnecessary Medications

• Deficiency Categorization

72
Deficiency Categorization

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

73
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

74
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

75
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

76
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

77
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

78
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

79
Pharmaceutical Services

• Guidance Training
• CFR 483.60, 483.60(a)(b)(1)
• F425

80
Training Objectives

• After todays session, you should be able to
• Describe the intent of the regulation
• Explain the regulatory components incorporated
  into F425
• Utilize the components of the investigative
  protocol
• Identify compliance with the regulation
• Appropriately categorize the severity of
  noncompliance

81
Regulatory Language(F425) 42 CFR 483.60

• The facility must provide routine and emergency
  drugs and biologicals to its residents, or obtain
  them under an agreement described in Sec.
  483.75(h) of this part. The facility may permit
  unlicensed personnel to administer drugs if State
  law permits, but only under the general
  supervision of a licensed nurse.

82
Regulatory Language Continued(F425) 42 CFR
483.60(a)(b)(1)

• (a) Procedures. A facility must provide
  pharmaceutical services (including procedures
  that assure the accurate acquiring, receiving,
  dispensing, and administering of all drugs and
  biologicals) to meet the needs of each resident.
  (b) Service consultation.

83
Regulatory Language Cont

• The facility must employ or obtain the services
  of a licensed pharmacist who
• Provides consultation on all aspects of the
  provision of pharmacy services in the facility.
• Establishes system of records of receipt and
  disposition of all controlled drugs in detail
• Determines that drugs are in order and that an
  account of all controlled drugs is maintained and
  periodically reconciled.
  
• 
  OHCA

84
Pharmaceutical Services

• Interpretive Guidelines

85
Interpretive GuidelinesComponents

• Intent
• Definitions
• Overview
• Provision of Routine and/or Emergency Medications
• Services of a Licensed Pharmacist
• Pharmaceutical Services Procedures
• Investigative Protocol (Sub-Task 5E)
• Determination of Compliance
• Deficiency Categorization

86
Interpretive GuidelinesIntent

• Facility provides pharmaceutical services to meet
  the needs to residents
• Medications and biologicals
• Services of licensed pharmacist
• Pharmaceutical services are coordinated within
  the facility
• Procedures developed and implementation evaluated
  
• Pharmaceutical concerns and issues affecting
  residents and care are identified and evaluated
• Only persons authorized under state requirements
  administer medications

87
Interpretive GuidelinesDefinitions

• Acquiring medication
• Administering medication
• Biologicals
• Current standards of practice
• Dispensing
• Disposition
• Pharmaceutical Services
• Pharmacy assistant or technician
• Receiving Medication

88
Interpretive GuidelinesDefinitions

• Dispensing - a process that includes the
  interpretation of a prescription selection,
  measurement, and packaging or repackaging of the
  product (as necessary) and labeling of the
  medication or device pursuant to a
  prescription/order.

89
Interpretive GuidelinesDefinitions

• Biologicals - are products isolated from a
  variety of natural sourceshuman, animal, or
  microorganismor produced by biotechnology
  methods and other cutting-edge technologies.
  They may include a wide range of products such as
  vaccine, blood and blood components, allergenics,
  somatic cells, gene therapy, tissues, and
  recombinant therapeutic proteins.

90
Interpretive Guidelines Definitions (Cont)

• Receiving medications
• Process of accepting medications from the
  facilitys pharmacy or outside pharmacy or an
  outside source (e.g., vending pharmacy delivery
  agent, Veterans Administration, family member

91
Interpretive GuidelinesDefinitions

• What is included in the concept of Pharmaceutical
  Services?

92
Interpretive GuidelinesDefinitions

• Pharmaceutical Services
• The process of receiving and interpreting
  prescribers orders acquiring, receiving,
  storing, controlling, reconciling, compounding
  (e.g., intravenous antibiotics), dispensing,
  packaging, labeling, distributing, administering,
  monitoring responses to, using and/or disposing
  of all medications, biologicals, chemicals
• The provision of medication-related information
  to health care professionals and residents
• The process of identifying, evaluating and
  addressing medication-related issues including
  the prevention and reporting of medication
  errors and
• The provision, monitoring and/or the use of
  medication-related devices.

93
Interpretive GuidelinesOverview

• Overall goal is to ensure safe and effective use
  of medications for each resident
• Risk of adverse consequences increases with
• Complex medication regimens
• Numbers and types of medications used
• Physiological changes associated with aging
• Multiple comorbidities
• Medication-related adverse consequences leading
  to death and serious events are too common and
  are often preventable

94
Interpretive GuidelinesOverview (cont)

• Pharmaceutical consultation is an ongoing,
  interactive process
• Pharmacists can use various methods and resources
  such as technology, additional personnel (e.g.
  dispensing pharmacist, pharmacy technicians, and
  related policies and procedures
• 
  OHCA

95
Interpretive GuidelinesProvision of Routine
and/or Emergency Medications

• Facility must provide or obtain routine and
  emergency medications and biologicals to meet
  needs of each resident
• Meeting needs includes timeliness
• Factors affecting timeliness
• Resident condition and risk factors
• Category of medication
• Ordered start time
• Availability of medications

96
Interpretive GuidelinesServices of a Licensed
Pharmacist

• Facility is responsible for employing or
  contracting pharmacist
• Pharmacist collaborates with staff to
• Provide feedback about medication administration
  practices and medical errors
• Develop, implement, evaluate and revise
  procedures
• Coordinate pharmaceutical services
• Develop intravenous therapy procedures
• Determining contents of supply of medications

97
Interpretive GuidelinesServices of a Licensed
Pharmacist

• Pharmacist collaborates to establish procedures
  for
• Conducting monthly MRR for each resident
• Addressing time frames
• Addressing irregularities
• Documenting and reporting results of review

98
Interpretive GuidelinesServices of Licensed
Pharmacist

• Develop mechanisms for communicating, addressing,
  resolving issues RT Pharmaceutical services
• Strive to assure meds are requested, received,
  administered timely
• Participate in IDT/ resolve med problems
• Develop PP regarding when to contact prescriber
  about med issues
• Recommend types of delivery systems
• Interact with QAA Committees
• Develop implement procedures regarding
  automated medication delivery systems or cabinets
• 
  OHCA

99
Interpretive GuidelinesPharmaceutical Services
Procedures

• Acquiring
• Receiving
• Dispensing
• Administering
• Disposition
• Labeling and storage of medications

100
Interpretive GuidelinesPharmaceutical Services
Procedures

• Pharmacist collaborates with Med Director to
  evaluate implementation of pharm services
• Acquisition of Medications - Examples
• Availability of supply (emergency or otherwise)
• When, how to and who may contact pharmacy
• Verification or clarification of orders
• Actions in response to delayed delivery or
  unavailability of medication
• Transportation of medications to prevent
  contamination, degradation, and diversion of
  medications

101
Interpretive GuidelinesPharmaceutical Services
Procedures

• Receiving Medications - Examples
• Receipt of medication and reconciliation with
  order and requisition for medication
• Staff identified and authorized to receive and
  deliver medication to secured area
• Staff responsible for assuring that medications
  are incorporated into residents specific
  allocation/storage area

102
Interpretive GuidelinesPharmaceutical Services
Procedures

• Dispensing Medications - Examples
• Delivery and receipt
• Labeling
• Types of medication packing

103
Interpretive GuidelinesPharmaceutical Services
Procedures

• Administering Medications Examples
• Preventing unnecessary interruptions during the
  medication pass
• Reporting of errors
• Using only authorized personnel to administer
  medications
• Assuring correct medication and dose given to
  correct person
• Defining schedules for administration
• Defining guidelines for specific monitoring
  related to medications
• Defining techniques and precautions for
  administration

104
Interpretive GuidelinesPharm Services Procedures

• Administering Meds- Examples
• Document administration of meds
• Routine as needed route if other than
  orallocation of administration sites
• Provide current info about medications
• Clarify incomplete orders, illegible, other
  concerns
• Reconcile med orders
• 
  OHCA

105
Interpretive GuidelinesPharmaceutical Services
Procedures

• Disposition of Medications Examples
• Removal of medications for disposition
• Storage method for medications awaiting final
  disposition
• Control and accountability of medications
  awaiting final disposition
• Method of disposition consistent with applicable
  state and federal requirements, local ordinances,
  and standards of practice

106
Interpretive GuidelinesPharmaceutical Services
Procedures

• Labeling Examples
• Requirements for labeling medications not labeled
  by a pharmacy, such as bulk supplies or IV
  solutions prepared or hung by facility staff
• Modifying labels due to changes in the medication
  orders or directions
• Labeling multi-dose vials to assure product
  integrity (e.g., modified expiration dates upon
  opening the multi-dose vial)

107
Interpretive GuidelinesPharmaceutical Services
Procedures

• Storage of Medications Examples
• Location, security (locking), and authorized
  access to the medication rooms, carts and other
  storage areas
• Temperatures and other environmental
  considerations of medication storage area(s)
• Location, access, and security for discontinued
  medications awaiting disposal

108
Interpretive GuidelinesPharmaceutical Services
Procedures

• Controlled Medications Examples
• Location, access, and security for controlled
  medications
• A system of records of receipt and disposition of
  all controlled medications that accounts for all
  controlled medications
• Periodic reconciliation of controlled medications

109
Interpretive GuidelinesPharmaceutical Services
Procedures

• Authorized Personnel Examples
• Assuring ongoing competency of staff
• Training on operation, limitations, monitoring,
  and precautions associated with medication
  administration
• Identifying personnel in addition to the
  pharmacist (e.g., pharmacy technicians,
  pharmacist assistants) who are authorized under
  state and federal requirements to access
  medications and biologicals.

110
Pharmaceutical Services

• Investigative Protocol

111
Pharmaceutical ServicesInvestigative Protocol

• Use Sub-Task 5E Medication Pass and Pharmacy
  Services

112
Use of Sub-Task 5E Medication Pass and
Pharmacy Services

• Services of licensed pharmacist
• Provision of pharmaceutical services

113
Pharmaceutical Services

• Determination of Compliance

114
Determination of Compliance

• Synopsis of Regulation
• Facility must provide routine and or emergency
  medications and biologicals or obtain them
• Facility must have pharmaceutical procedures to
  meet the residents needs
• Facility must have a licensed pharmacist who
  provides consultation and oversees service
• Facility must follow laws about who may
  administer medications

115
Determination of ComplianceCriteria for
Compliance

• The facility is in compliance if they provide
• Medications and/or biologicals for each resident
  as ordered by the prescriber
• Development and implementation of procedures for
  the pharmaceutical services
• A pharmacist who provides consultation regarding
  all aspects of pharmaceutical services
• Personnel to administer medications, consistent
  with applicable state law and regulations

116
Determination of ComplianceNoncompliance for F425

• Noncompliance may include the facility failure
  to
• Utilize the services of a pharmacist
• Ensure that only appropriate personnel administer
  medications
• Provide medications and/or biologicals to meet
  the needs of the resident
• Develop or implement procedures for any of the
  following acquiring, receiving, dispensing or
  accurately administering medications

117
Determination of CompliancePotential Tags for
Additional Investigation

• F353 Sufficient Staff
• F501 Medical Director
• F520 Quality Assessment and Assurance
• F514 Clinical Records

118
Pharmaceutical Services

• Deficiency Categorization

119
Deficiency CategorizationSeverity 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

120
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

121
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 cause serious
  injury, harm, impairment, or death to a resident
• Requires immediate correction

122
Deficiency CategorizationSeverity Level 4 - IJ

• Examples
• Failure to assure availability of pain med for
  new admission resulting in R c/o of excruciating
  pain
• Failure to assure that devices used to administer
  meds are working properly
• Meds being administered without valid prescribers
  order resulting in R incorrectly receiving 3 meds
  over two month
• 
  OHCA

123
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

124
Deficiency CategorySeverity Level 3 Actual Harm

• Examples
• Transcription error led to incorrect dose and the
  Resident experienced spontaneous bruising and
  epistaxis requiring medical intervention
• Staff not trained or competent to use a new
  medical-related device and the R received an
  excessive dose of medication requiring subsequent
  hospitalization or
• R received a sub therapeutic dose causing an
  exacerbation of the condition and subsequent
  decline in function
• 
  
• 
  OHCA

125
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

126
Deficiency CategorizationSeverity Level 2
Potential Harm

• Examples
• As result of not enough meds A R did not
  receive medication for heartburn and had
  difficulty sleeping due to nocturnal heartburn
• Because of a failure to ID meds that should not
  be crushed, R received meds that were crushed. R
  did not experience harm but there was a
  potential for harm

127
Deficiency CategorizationSeverity Level
1Potential for Minimal Harm

• Level 1 No actual harm with potential for
  minimal harm
• Verify that no resident harm or potential for
  more than minimal harm identified at other
  requirements was related to
• Lack of pharmaceutical services
• Absence of or failure to implement pharmaceutical
  procedures
• Absence of or oversight by pharmacist

128
Medication Regimen Review

• Guidance Training
• CFR 483.60(c)(1)(2)
• F428

129
Training Objectives

• After todays session, you should be able to
• Describe the intent of the regulation
• Identify triggers leading to an investigation of
  F428
• Identify and utilize the components of combined
  investigative protocol that address MRR
• Identify compliance with the regulation
• Appropriately categorize the severity of
  noncompliance

130
Regulatory Language(F428) 42 CFR 483.60(c)(1)(2)

• (c) Drug regimen review. (1) The drug regimen of
  each resident must be reviewed at least once a
  month by a licensed pharmacist. (2) The
  pharmacist must report any irregularities to the
  attending physician and the director of nursing,
  and these reports must be acted upon.

131
Medication Regimen Review

• Interpretive Guidelines

132
Interpretive GuidelinesComponents

• Intent
• Definitions
• Overview
• Medication Regimen Review
• Investigative Protocol (Refer to F329)
• Determination of Compliance
• Deficiency Categorization

133
Interpretive GuidelinesIntent

• The facility maintains residents highest level
  of functioning and prevents/ minimizes adverse
  consequences related to medication therapy to the
  extent possible, by providing
• Licensed pharmacists review of each residents
  regimen
• Identification and reporting of irregularities
• Action taken in response to irregularities

134
Interpretive GuidelinesDefinitions

• Adverse consequence
• Clinically significant
• Dose
• Duration
• Irregularity
• Medication interaction
• Medication Regimen Review
• Monitoring
• Pharmacy Assistant/Technician

135
Interpretive GuidelinesDefinitions

• Medication Regimen Review - a thorough evaluation
  of the medication regimen of a resident, with the
  goal of promoting positive outcomes and
  minimizing adverse consequences associated with
  medication. The review includes preventing,
  identifying, reporting, and resolving
  medication-related problems, medication errors,
  or other irregularities, and collaborating with
  other members of the interdisciplinary team

136
Interpretive GuidelinesDefinitions

• Medication Interaction - the impact of another
  substance (such as another medication, herbal
  product, food or substances used in diagnostic
  studies) upon a medication.  The interactions may
  alter absorption, distribution, metabolism, or
  elimination.  These interactions may decrease the
  effectiveness of the medication or increase the
  potential for adverse consequences

137
Interpretive GuidelinesDefinitions

• Irregularity - any event that is inconsistent
  with usual, proper, accepted, or right approaches
  to providing pharmaceutical services (see
  definition in F425), or that impedes or
  interferes with achieving the intended outcomes
  of those services

138
Interpretive GuidelinesDefinitions

• Adverse consequence
• Unpleasant symptom due to or associated with a
  medication
• Monitoring
• Ongoing collection analysis of information
  (e.g. observation/diagnostic test and comparison
  to baseline data
• OHCA

139
Interpretive GuidelinesOverview

• Factors increasing the risk of medication related
  issues
• Multiple medications are often required to
  address conditions, leading to complex medication
  regimens
• Adverse consequences can mimic symptoms of
  chronic conditions (aging process, new
  conditions)
• Transitions, such as a move from hospital to
  nursing home Medications may be added,
  discontinued or changed

140
Interpretive GuidelinesOverview (continued)

• Reviews to help identify issues
• Physician reviews orders and total program of
  care on admission and prescriber reviews at each
  visit
• Nurse reviews medications when sending orders to
  pharmacy and/or prior to administering
  medications
• Interdisciplinary team reviews as part of the
  comprehensive assessment for the RAI and/or care
  plan
• Pharmacist reviews the prescriptions prior to
  dispensing
• Pharmacist performs medication regimen review at
  least monthly

141
Interpretive GuidelinesMedication Regimen Review

• MRR Essential Components
• Conducted At Least Monthly
• Identifies and Reports
• Irregularities such as medication errors, and
• Adverse consequences risks
• Reported Irregularities acted upon

142
Interpretive GuidelinesIdentification of
Irregularities

• Irregularities may be identified through review
  of
• Medication administration records (MAR)
• Prescribers orders
• Progress, nursing and consultants notes
• Resident Assessment Instrument (RAI)
• Laboratory and diagnostic test results
• Behavioral monitoring information

143
Interpretive GuidelinesIdentification of
Irregularities

• Pharmacist considers whether physician and staff
  have
• Documented indications for use
• Identified allergies, potential side effects, and
  medication interactions
• Documented progress towards goals
• Acted upon laboratory results and diagnostic
  studies
• Acted upon possible medication-related causes of
  worsening in the residents condition

144
Interpretive GuidelinesIdentification of
Irregularities

• Examples of changes that may or may not be
  related to medication use include
• Anorexia
• Behavioral changes
• Bowel function changes
• Confusion, cognitive decline
• Dehydration, fluid/electrolyte imbalance
• Depression, mood disturbance
• Dysphagia, swallowing difficulty
• Excessive sedation, sleep disturbance

145
Interpretive GuidelinesIdentification of
Irregularities

• Examples continued
• Evidence of impaired coordination
• Gastrointestinal bleeding
• Generalized aching or pain
• Rash, pruritus
• Seizure activity
• Spontaneous or unexplained bleeding, bruising
• Unexplained decline in functional status (e.g.,
  ADLs, vision)
• Urinary retention or incontinence

146
Interpretive GuidelinesIdentification of
Irregularities

• Additional categories may include
• Use of appropriate medication with lack of
  progress toward therapeutic goal, potentially
  related to
• Sufficiency of dose
• Dosing intervals or timing of administration
• Administration technique
• Use of excessive dose or duration

147
Interpretive GuidelinesIdentification of
Irregularities

• The use of a medication without
• Identifiable evidence of adequate indications for
  use
• Identifiable evidence that safer alternatives or
  more clinically appropriate medications have been
  considered
• Evidence of adequate monitoring
• The presence of an adverse consequence associated
  with the residents current medication regimen
• Presence of medication errors or the risk for
  such errors
• A medication interaction associated with the
  current medication regimen

148
Interpretive GuidelinesLocation and Notification
of MRR Findings

• The Pharmacist must
• Document identification of irregularity
• Report irregularity to attending physician or
  director of nursing
• Timeliness of notification depends on severity
• If no irregularities found, pharmacist signs
  statement indicating such

149
Interpretive GuidelinesResponse to
Irregularities Identified in the MRR

• Physician is not required to order recommended
  treatments unless he/she determines they are
  medically valid/indicated
• If recommendation requires physician
  intervention, then
• Physician accepts and acts upon suggestion
• Or
• Physician rejects and provides explanation for
  disagreeing

150
Interpretive GuidelineResponse to Irregularities
ID in MRR

• If a potential for serious harm exists and
  physician does not concur with or take action
• Facility and pharmacist should contact facility
  medical director for guidance and possible
  intervention
• 
  OHCA

151
Medication Regimen Review

• Investigative Protocol

152
Investigative Protocol

• Objectives
• Use
• Procedures

153
Investigative Protocol

• Objectives
• Determining if the pharmacist
• Performed the monthly MRR
• Identified any irregularities
• Reported any identified irregularities to the
  attending physician and director of nursing
• Determining whether the facility and/or
  practitioner acted on the report of any
  irregularity
• Use the protocol
• On every initial and standard survey
• On revisits or abbreviated survey (complaint
  investigation) as necessary

154
Investigative Protocol

• Procedures
• Implement the Investigative protocol listed at
  F329 to help identify whether there are potential
  issues with regard to MRR
• Conduct observations, interviews and record
  reviews as necessary related to the provision of
  the MRR

155
Investigative Protocol

• Procedures
• Determine if the pharmacist
• Identified irregularities, if any and
• Reported the irregularities to the director of
  nursing and attending physician

156
Investigative Protocol

• Procedures
• Response to the identification of any
  irregularities

157
Medication Regimen Review

• Determination of Compliance

158
Determination of ComplianceSynopsis of Regulation

• A review by the pharmacist of each residents
  medication regimen at least once a month or more
  frequently depending upon the residents
  condition and the risks or adverse consequences
  related to current medication(s)
• The identification of any irregularities
• Reporting irregularities to the attending
  physician and the director of nursing
• Action in response to irregularities reported

159
Determination of ComplianceCriteria for
Compliance

• MRR performed on each resident at least once a
  month or more frequently depending upon the
  residents condition and/or risks or adverse
  consequence associated with the medication
  regimen
• Pharmacist identified any existing irregularities
• Pharmacist reported any identified irregularities
  to the director of nursing and attending
  physician
• Any reported irregularities have been acted upon

160
Determination of ComplianceNoncompliance for F428

• The pharmacist failed to
• Conduct an MRR at least monthly (or more
  frequently, as indicated)
• Identify or report
• the absence of indications for use of a
  medication
• a medication or medication combination with
  significant potential for adverse consequences or
  medication interactions
• medications in a residents regimen that could be
  causing new, worsening, or progressive symptoms

161
Determination of ComplianceNoncompliance for
F428 (cont)

• The facility failed to assure that
• A report of clinically significant risks or
  existing adverse consequences or other
  irregularities was acted upon

162
Determination of CompliancePotential Tags for
Additional Investigation

• F157 Notification of Changes
• F329 Unnecessary Medications
• F385 Physician Supervision
• F386 Physician Visits
• F425 Pharmacy Services
• F501 Medical Director

163
Medication Regimen Review

• Deficiency Categorization

164
Deficiency CategorizationSeverity 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

165
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

166
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 cause serious
  injury, harm, impairment, or death to a resident
• Requires immediate correction

167
Deficiency CategorySeverity Level 4 IJ

• Examples
• Despite identifying irregularities pharmacist
  did not report irregularities to attending
  physician or no action was taken on the
  irregularities report
• Repeated or cumulative failures in multiple areas
  of medication regimen review process (e.g.
  failure to identify, report, or act upon) that
  resulted in the residents experiencing actual or
  potential harm
• 
  OHCA

168
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

169
Deficiency CategorySeverity Level 3 Actual Harm

• Examples
• Pharmacist failed to ID the indication for
  continued use for opioid analgesics that were
  prescribed for a R acute pain, which had resolved
• MRR reflected staff were crushing a med that
  should not have been crushed/ as result, the R
  experienced significant adverse consequences such
  as hypoglycemia or hypotension that required
  medical intervention
• 
  OHCA

170
Deficiency CategorySeverity Level 3 Actual Harm

• Examples (cont)
• Pharmacist ID medics that were not given as