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What are
Unnecessary Medications?
ďą Excessive doses
ďą Excessive duration
ďą Without adequate monitoring
ďą Without adequate indications for use
ďą Presence of adverse consequences
indicating dose should be reduced or
discontinued.
6. There are 5 questions to consider to prevent
connecting these F-tags to one another
1. Do the target symptoms warrant
medications?
2. Are non-pharmacological interventions in
place and relevant?
3. Is medication appropriate to manage the
symptoms or condition?
4. Do the intended or actual benefits justify
the risk of use?
5. Is there a system in place to insure these
criteria are adhered to?
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Key Terms
Linked to Unnecessary Med Use
1. ADE: Adverse Drug Effect
2. ADR: Adverse Drug Reaction
3. Poly-pharmacy
4. Predictability
5. Medication Errors
6. Beers List
7. Immediate Jeopardy
8. Professional standards of practice
8. Defining Key Terms
ADVERSE DRUG EFFECT:
Basket term that captures med
errors and ADRâs.
⢠ADEs can have different
outcomes: worsening of existing
condition, or lack of expected
improvement.
⢠Statistically: 2 ADEâs /100 residents
More than half of adverse drug
events may be preventable.
ADVERSE DRUG REACTION:
⢠Any unintended response to a drug
that is Harmful / noxious in doses
for diagnosis, prophylaxis, or
therapy.
⢠High risk med categories:
Psycho tropics, analgesics,
anticoagulants, antibiotics,
cardiovascular
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9. Key Terms contâ
⢠Polypharmacy : lots of meds
⢠Predicatblitiy: primary concern
⢠MEDICATION ERRORS
Any preventable event that can
cause or lead to inappropriate
medication use or patient harm
while the medication is in control of
the health professional.
DAMP: mistakes are related to
dispensing, administering, or
monitoring , prescribing,
5 errors / 100 residents
⢠BEERS LIST: medication with high
risk side effects that outweigh
benefits of use; meds that are
inappropriate at any dose; specific
meds used at low with caution.
⢠Immediate Jeopardy: scope
H I L K L
⢠STANDARDS of PRACTICE:
The various practice regulations in
each State, and commonly
accepted health standards
established by national
organizations, boards and councils.
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Failure to protect from undue adverse med
consequences or failure to provide med as prescribed.
1. Administration of medication to an individual with a
known history of allergic reaction to that medication.
2. Lack of monitoring and identification of potential serious
drug interaction, side effects and adverse reactions.
3. Administration of contraindicated medications.
4. Pattern of repeated medication errors without
intervention.
5. Lack of timely and appropriate monitoring required for
drug titration.
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Degree of the
Problem
Isolated Pattern Wide-
spread
Immediate
Jeopardy J K L
Actual
Harm G H I
Potential for
Harm D E F
No harm
likely A B C
From a
citation
perspective,
what are the
potential
scope and
severity of
slide 10
failures
and why?
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Adverse Drug Events
⢠Pharmacodynamics:
drugs with similar or
opposing effects
⢠Pharmacokinetics:
what the body does to
a drug
AD ME
⢠Absorption
⢠Distribution
⢠Metabolism
⢠Elimination
13. Pharmacokinetics: ADME
What the body does to a drug
⢠ABSORPTION: bowel surface
decreases with age and gastric
juices increase.
⢠DISTRIBUTION: Total body
water decreases 10 to 15%
with aging. Results in possible
higher blood concentrations of
some water-soluble drugs;
⢠Body weight that is body fat
increases from 18 to 36% in
men and from 33 to 45% in
women. Result is fat soluble
drugs take longer to eliminate.
⢠METABOLISM: liver mass and
blood flow decrease = harder
to breakdown and eliminate
⢠ELIMINATION: renal mass
and blood flow decrease =
reduced elimination of drug.
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Preventable Adverse Drug Effects
Occur at Ordering
ďą Wrong drug choice
ďą Failure to consider drug interactions
ďą Transcription errors
Occur at Monitoring
ďą Failure to order specific monitoring needs
ďą Delayed response or failure to respond to signs &
symptoms of toxicity or lab evidence of toxicity
15. An adverse drug reaction is any unexpected,
unintended, undesired, or excessive response to a
drug that requires
⢠Discontinuing the drug (therapeutic or diagnostic)
⢠Changing the drug therapy
⢠Modifying the dose (except for minor dosage adjustments)
⢠Necessitates admission to a hospital
⢠Prolongs the stay in a health care facility
⢠Necessitates supportive treatment
⢠Significantly complicates diagnosis
⢠Negatively affects prognosis
⢠Results in temporary or permanent harm, disability, or death
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Surveyor Assessment
1. Indications / reasons for use.
2. Effectiveness, dose.
3. Monitoring: drug regimen, response to
irregularities.
4. Duplication of drug therapy.
5. Presence of Adverse Drug Events
6. Weight history of note.
7. Hydration / intake records of note.
18. Surveyors assessing for
1. Indications / reasons for use: Assessment and rationale
2. Effectiveness, dose: Baseline, dose range, expected outcome and
time line to see it.
3. Monitoring: drug regimen, response to irregularities: MUST
ESTABILISH BASELINE, Gatekeepers are: direct care, charge
nurse, physician, pharmacist.
4. Duplication of drug therapy: same class, similar side effects.
5. Presence of Adverse Drug Events: predictable v. unpredictable
6. Weight history of note: gain or loss, anorexia, dysphagia /
swallowing problems.
7. Hydration / intake records of note: evaluation of change in
hydration, fluid, electrolyte balance.
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Regulatorâs Looking For:
⢠Comprehensive Assessment
Condition, risk, needs, behaviors
⢠Quality of Care
Lethargy, sedation, bowel problems, sleep disturbance, increased pain
⢠ADL decline
NEW or rapid decline; decline in function or tolerance
⢠Urinary Incontinence
Change in function or status
⢠Mental and Psychosocial function
Change in behavior, depression, mood, agitation, restlessness, confusion, delirium
⢠Physician Services and Visits
⢠Medical Director
Procedures in place to resolve concerns
⢠Pharmacy Services
Medical Regimen Review
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Predictability
Reactions can be immediate as in anaphylaxis, but generally
requires 5 days of treatment, most show by 12 weeks
PREDICTABLE
⢠Usually dose dependent.
⢠Most identified prior to
marketing.
⢠Can be due to
concomitment disease,
drug/drug, and food/drug
interactions.
⢠Rarely life threatening
but can produce
significant disability.
UNPREDICTABLE
⢠Usually not an extension
of the known drug
properties.
⢠Generally independent of
dose and route of
administration.
⢠Includes idiosyncratic
reactions, immunologic or
allergic reactions.
⢠Tend to concentrate in
liver, kidneys, and
nervous system.
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Types of Adverse Drug Reactions
1. Drug / Drug Interactions
2. Drug / Nutrient Interactions
3. Allergic Reactions / Hypersensitivity
4. Drug Toxicity
5. Idiosyncratic Reaction
6. Complications
7. DRUG / DISEASE INTERACTIONS
22. Prevalence of ADR-related Hospitalizations
ranges from 5% to 35%. ADEs are estimated to cost the health care
system $75 billion to $85 billion annually.
⢠Drug / Drug Interactions: PHARMACOKINETICS AND DYNAMICS
40% elderly at risk
⢠Drug / Nutrient Interactions:
⢠Allergic Reactions / Hypersensitivity
⢠Drug Toxicity: concurrent use of different drugs with same toxicity
side effects
⢠Idiosyncratic Reaction
⢠Complications
⢠DRUG / DISEASE INTERACTIONS: exacerbation of the disease by
the drug (i.e. anti-cholinergic are the most common cause:
glaucoma, BPH, ALTZ, dry eye)
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23. Minimizing Occurrence
⢠Understand
pharmacokinetic and
pharmacodynamics.
⢠Monitor drugs with narrow
therapeutic range.
⢠Avoid polypharmacy.
⢠Know, convey, and
document baseline
status.
⢠The pharmacist is the
primary gatekeeper:
Monthly or more often
(worsening status first 30 days).
⢠MRR (medication
record review) is
designed to:
â Prevent
â Identify
â Report
â Resolve MRPâs
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Factors that Produce/ Contribute to
Inappropriate Drug Use
1. Under use of medications
2. Over use of medications
3. Poly pharmacy
4. Excessive dose or duration
5. Lack of assessment
6. Lack of monitoring
7. Lack of recognition of ADRâs
8. Lack of adherence to drug therapy
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Assessing a Possible ADR
1. Review the current medications in use for
associations with symptoms or condition
change.
2. Assess other possible causes for signs and
symptoms.
3. Validate the drug ordered is the drug given.
4. Verify that the onset of the event was AFTER
drug administration initiated.
5. Determine the time interval between the
beginning of drug treatment and the onset of
the event.
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Safeguards
Prevention of Adverse Drug Reactions
1. Consider any new symptom as a possible ADE before
requesting/ administering new medication for the
symptom.
2. Monitor medication orders for wrong drug choices (high-
risk inappropriate medications, drugâdisease and drugâ
drug interactions), wrong dosages, or admin errors.
3. Improve prescribing practices by documenting:
+ indication for initiation of new drug therapy
+ maintaining a current medication list
+ documenting response to therapy.
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Polypharmacy
⢠Concomitant use of multiple drugs, done by
simply drug counting.
⢠Administration of more medications than is
clinically-indicated.
⢠34% of all drugs prescribed in the United States
are considered unnecessary.
References:
Stewarb RB. Polypharmacy in elderly: a fair accompli? DICP 1990; 24; 321-323. Montamat SC,
Cusack B. Overcome the problems with polypharmacy and drug misuse. Clin Geriatr Med 1992; 8:
143-158. LeSage J. Polypharmacy in the geriatric patient. Nurs Clin North Am 1991; 26: 273-287.
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Possible Impacts of Polypharmacy
⢠Adverse drug reactions
⢠Drug-drug interactions
⢠Medication errors made up of non-
compliance
⢠Link to 5% of hospital admission
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Preventing Polypharmacy
Gather information
⢠Determine all medications being used.
⢠Identify meds by generic name & drug class.
⢠Identify the clinical indication of each
medication.
⢠Know the side effect profile of each
medication.
⢠Identify risk factors for an adverse drug
reaction.
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Preventing Polypharmacy
Eliminate, Substitute and Simplify
⢠Eliminate medication with no therapeutic benefit.
⢠Eliminate medication with no clinical indication.
⢠Substitute a safer medication.
⢠Avoid treating an adverse drug reaction with a
drug.
⢠Use a single drug with an infrequent dosing
schedule.
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Treatment Principles
Psychoactive Medications
1. Rule out and/or stabilize
medical problems
2. Check critical lab work
3. Create a list of behavior
disturbances that need
to be improved.
4. Augment therapy if
needed.
5. Set realistic goals
6. Establish routine
7. Provide physical clues
8. Talk before touch
9. 1 step commands
10. Allow adequate time for
medications trial
11. Specify and quantify
improvement
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Behavior Questions
1. What is the behavior;
how long does it lasts?
2. Are psychoactive
medications used?
3. Is behavior creating care
resistance or is care
creating behavior
problem?
4. What do you believe are
the potential causes or
contributors to the
behavior problem?
5. Can the behavior be
easily altered?
6. If not, why not?
7. Has the use of
medication been
considered?
8. Have you evaluated the
triggered RAPs and
triggered Quality
Indicators?
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Questions for Behavior & PA Meds
ďŠ What are the
symptoms?
ďŠ What is the
frequency?
ďŠ What is the
severity?
ďŠ What is the ease
of alterability?
If easily altered
⢠Are they receiving psychoactive
meds?
⢠How long?
⢠Are side effects present?
⢠Is a reduction program needed or
underway?
If not easily altered
⢠Have physical causes been ruled
out?
⢠Might there be drug interactions
creating the problem? How do you
know?
⢠Are they receiving Psych meds? How
long? Has behavior improved? If not,
why not? What now?
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Questions for Depression & PA Meds
ďŠ What are the symptoms ?
ďŠ If you donât think these
symptoms are mood
related, why?
ďŠ How have you come to
this decision?
ďŠ How pervasive?
ďŠ How serious?
ďŠ How easily altered?
ďŠ Are psychoactive, anti-
anxiety, hypnotics in use?
ď§ If easily altered & receiving
antidepressant are they a
candidate for reduction?
⢠If NOT easily altered and
receiving antidepressant
how long has med been
given?
ď§ If NOT easily altered and
NOT receiving
antidepressant are they a
candidate?
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Antipsychotic Meds
Can you justify use?
High Risk: Cognitive Impairment
Criteria: Harm to self or others; symptoms
so distressing impacts ability to function
Low Risk: major mental illness, psychosis,
schizophrenia, manic depression
Criteria: Supporting Diagnosis
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Anti-Anxiety Med Questions
ď§ Is this a resident demand or clinical need?
ď§ What attempts have been made to address this?
ď§ Is there a risk plan in place?
ď§ Are there adverse effects that can be tied to other
problems?
ď§ Is it clinically indicated? If so what are risks, concerns?
ď§ Is documentation in place?
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Minimize Unnecessary Drug Use
⢠Drug protocols
⢠Quality assurance
⢠Communication
⢠Initial and ongoing
assessment
⢠Care Plan
development and
implementation
⢠Gait keeper
⢠Staff training:
ď§ meds used, dose
ranges, side effects,
potential complications
ď§ implication of cognitive
compromise
ď§ catastrophic
responses leading to
unnecessary med
orders.
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Assessment Tools for Benchmarking Behavior
⢠Behavior Pathology in Alzheimer's Disease Rating
Scale (BEHAVE-AD), Measures agitation/anxiety,
psychosis, aggression, depression, and activity
disturbance.
⢠Cohen-Mansfield Agitation Inventory (CMAI), a
questionnaire evaluating agitation.
⢠Clinical Global Impressions (CGI), a rating system
used to evaluate the overall and severity of clinical
change in a patient with various diseases affecting the
brain.
⢠Functional Assessment Staging (FAST), a diagnosis
tool for determining the stage of dementia
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Assessment Tools for Benchmarking Behavior Contâ
⢠AIMS abnormal involuntary movements
associated with antipsychotic drugs.
⢠NPI neuropsychiatric inventory assessment of
psychopathology for dementia and other neuro-
psychiatric disorders.
⢠CAM: screens for overall cognitive impairment.
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REASONS FOR MEDICATION USE
⢠Cure acute illness
⢠Arrest or slow disease process.
⢠Decrease or eliminate symptoms.
⢠Prevent a disease or symptom.
⢠Therapeutic or enabling for a resident
with chronic mental or physical problems.
The FUNDAMENTAL ISSUES to be addressed in
the CMS guidelines is the lack of clear,
solid clinical rational for use of the specific medication identified.
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Best Practice
Behavior Management
Psychoactive Drugs, Physical Restraints,
Editor's Notes
Meds are a key component in the clinical process. The guidelines are intended to insure medication use is of value and necessary. T Significant emphasis is placed on preventing and recognizing adverse drug reactions ASAP. Consequently, surveyors will expect to see: Rationale for use Parameters for monitoring Prompt recognition and evaluation of new onset problems and conditions worsening Consideration for dose reduction and discontinuance as appropriate.
Excessive doses : given at one time or over a period of time Excessive duration : longer than required or needed Without adequate monitoring : not paying attention to changes or outcomes occurring Without adequate indications for use : failure to establish rationale for use Presence of adverse consequences indicating dose should be reduced or discontinued : Failure to recognize change and / or take action as indicated or needed.
In your facility what might you consider as unnecessary and why? UNNECESSARY MEDS ARE D 2 UM
There are 5 questions to consider to prevent connecting these tags to one another Do the target symptoms warrant medications? Are non-pharmacological interventions in place and relevant? Is medication appropriate to manage the symptoms or condition? Do the intended or actual benefits justify the risk of use? Is there a system in place and to insure these processes are adhered to?
Group exercise: From a citation perspective, what are the potential scope and severity of these and why?
Pharmacodynamics : The response of the body to the drug ; It is the time course and effect of the drugs on cellular and organ function. With aging there is increased sensitivity R/I > ADRâs and toxcity. Problems tend to occur when two or more drugs together can âadd upâ to increase effect, magnify or inhibit the effect of the other med. Pharmacokinetics : what the body does to a drug ABSORPTION: bowel surface decreases with age and gastric juices increase. DISTRIBUTION: Total body water decreases 10 to 15% with aging. Results in possible higher blood concentrations of some water-soluble drugs Body weight that is body fat increases from 18 to 36% in men and from 33 to 45% in women. Result is fat soluble drugs take longer to eliminate. METABOLISM: liver mass and blood flow decrease = harder to breakdown and eliminate ELIMINATION: renal mass and blood flow decrease = reduced elimination of drug. BOTTOM LINE : Long Term and Maintenance therapy requires dose adjusted reviews especially with acute illness and dehydration.
An adverse drug reaction is any unexpected, unintended, undesired, or excessive response to a drug that: Requires discontinuing the drug (therapeutic or diagnostic) Requires changing the drug therapy Requires modifying the dose (except for minor dosage adjustments) Necessitates admission to a hospital Prolongs stay in a health care facility Necessitates supportive treatment Significantly complicates diagnosis Negatively affects prognosis Results in temporary or permanent harm, disability, or death System issues at the facility are a key concern of regulators which gives as pause to determine how Preventable Adverse Drug Effects come about. Occur at Ordering Wrong drug choice PA v. pain med Failure to consider drug interactions pharm v diet Transcription errors Nsg, md, pharm Occurr at Monitoring Failure to order specific monitoring needs: blood test md, pharm, nsg Delayed response or failure to respond to signs & symptoms of toxicity or lab evidence of toxicity: NF system issues, oversight, FU day to day, and qa DRUG CLASSES OF CONCERN; Diuretics, ANTIâs, Hypnotics
Start low and go slow. Monitor for potential side effects i.e. mental status changes
Use as a key to keep surveyors on track and as response criteria on 2567âs . Reactions can be immediate as in anaphylaxis, but generally requires 5 days of treatment, most show by 12 weeks
Prevalence of ADR-related hospitalizations ranges from 5% to 35%. ADEs are estimated to cost the health care system $75 billion to $85 billion annually Drug / Drug Interactions: PHARMACOKINETICS AND DYNAMICS 40% elderly at risk Drug / Nutrient Interactions: Allergic Reactions / Hypersensitivity Drug Toxicity: concurrent use of different drugs with same toxcity side effects Idiosyncratic Reaction Complications DRUG / DISEASE INTERACTIONS: exacerbation of the disease by the drug (i.e. anti-cholinergic are the MOSY common cause: glaucoma, BPH, ALTZ, dry eye
Resolve MRPâs
1. Underuse of medications Untreated indications . The patient has a medical problem that requires drug therapy but is not receiving a drug for that indication. Subtherapeutic dosage . The patient has a medical problem that is being treated with too little of the correct medication. 2 . Overuse of medications Drug use without indication . The patient is taking a medication for no medically valid indication. Overdosage . The patient has a medical problem that is being treated with too much of the correct medication. 3. Use of inappropriate medications Improper drug selection . The patient has a drug indication but is taking the wrong drug, or is taking a drug that is not the most appropriate for the special needs of the patient. 4. Adverse drug reactions, including drug interactions Adverse drug reactions . The patient has a medical problem that is the result of an adverse drug reaction or adverse effect. Drug interactions. The patient has a medical problem that is the result of a drug-drug, drug-food, or drug-laboratory test interaction. 5. Lack of assessment 6. Lack of monitoring 7. Lack of recognition of ADRâs 8. Lack of adherence to drug therapy (patient noncompliance) Failure to receive medication. The patient has a medical problem that is the result of not receiving a medication due to economic, psychological, sociological, or pharmaceutical reasons.
Review the current medications : CALL PHARMACIST and ask!. 2. Assess other possible causes for signs and symptoms: PMS/E 3. Validate the drug ordered is the drug given: ck drug, dose, freq against MAR and order 4. Verify that the onset of the event was AFTER drug administration initiated. 5d-12wk 5.Determine the time interval between the beginning of drug treatment and the onset of the event. Does it fit with pharmocdynamics?
AVOID the prescribing cascade (example in context).
What medications does the resident really need and why?
Know and report the meds/dosages resident is taking when requesting orders.
Go to next slide for group exercise
Altered cognition : Delirium, dementia, catastrophic reactions/task failure, schizophrenia, and mental illness/retardation. Altered emotions: There are different types of depression. Reactive, the most common; Affective, a recurrent mood disorder; Symptomatic/Secondary, related to neurological disease. Disturbances of mood: Emotional labiality precipitated by thoughts, and/or circumstances; or pathological, related to disease processes such as multiple sclerosis or strokes. Physical Illness altering level of consciousness, infection, pain or disfigurement can create behavioral disturbances. The key question: Is the behavior change consistent with physical illness? Drug toxicity: Is the behavior drug induced? Can you make a correlation with drug use and onset of behavior? Donât be fooled by a lab test that indicates drug is within therapeutic range. Drug toxicity can be present in the elderly despite ânormalâ lab reports.
Aggression offensive = ASSUALTIVE defensive = RESISTIVE Stimulus internal = delusion / hallucination external = environment, light, noise, certain people
Amnesia: inability to learn new information. Aphasia: Difficult comprehension; unable to follow instructions; unable to participate in conversation; unable to express need. Apraxia: Loss of ability to do learned motor skills Agnosia: Loss of ability to recognize objects
Is there supporting criteria for the drug category being used? If so, Is behavior a threat, distressing or harmful to self or others?
Are they high risk Cognitively impaired, psychotic, manic depressive Are they low risk? What are the symptoms? Verbal abuse, physical; abuse, socially inappropriate What is the frequency? What is the severity? What is the ease of alterability?
If easily altered and receiving antidepressant are they a candidate for reduction? If not, why not? If so, what is the plan and what are the potential risk? If NOT easily altered and receiving antidepressant how long has med been given? Is there a need to adjustment or change? If not, why? If NOT easily altered and NOT receiving antidepressant are they a candidate? If not why not and what are the risk and concerns? What is the plan for managing?
Continued Use? Drug Reduction attempted? If contraindicated record clearly demonstrates why. Are symptoms easily altered? If so, consider length of use & possible reduction program. If not , how long on med? Has there been any improvement? If not new drug is higher dose indicated OR reassess cause factors? Are other psychoactives in use? Has ADR presence / potential investigated?
If Use is PRN Is it given pro-actively to facilitate treatment or calm in anticipation of predicable reaction? Is there a care plan in place for this? Is effectiveness noted? Is med used in response to behavior outburst or mood problem? Could that outburst have been anticipated and dealt with non-medically and/or proactively with medication? Is care plan in place? Is there documentation of need and interventions tried prior to administration? Is effectiveness noted? Is there monitoring for adverse effects?
Staff training on implication of cognitive loss & CATASTROPHIC RESPONSES. Sensitizing staff to resident perspective. Quality assurance oversight. Drug usage Relationship of functional status to drug use Accuracy of assessment Effectiveness of care plan Staff comprehension of cognitive loss, mood and behavior problems. Develop drug protocols. Effective communication with physician. Accurate assessment and ongoing evaluation. Consistent implementation of the care plan.