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 > ADR’s and toxcity. Problems tend to occur when two or more drugs together can “add up” 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, ANTI’s, 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 2567’s . 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
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 ADR’s 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? Don’t be fooled by a lab test that indicates drug is within therapeutic range. Drug toxicity can be present in the elderly despite “normal” 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.
Standards of Practice
Debbie Ohl RN, NHA, M.Msc., Ph.D
Ohl & Associates
Consultant and Educator
Without adequate monitoring
Without adequate indications for use
Presence of adverse consequences
indicating dose should be reduced or
In your own words, what
do you consider to be
UNNECESSARY MEDS ARE
DOSE, DURATION, USE, & MONITORING
ARE NOT IN PLACE
• Unnecessary Drug Use
• Antipsychotic Drugs
• Medication Errors
• Drug Regimen Review
• Comprehensive assessment
• Care planning
• Professional standards of practice
There are 5 questions to consider to prevent
connecting these F-tags to one another
1. Do the target symptoms warrant
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?
Linked to Unnecessary Med Use
1. ADE: Adverse Drug Effect
2. ADR: Adverse Drug Reaction
5. Medication Errors
6. Beers List
7. Immediate Jeopardy
8. Professional standards of practice
Defining Key Terms
ADVERSE DRUG EFFECT:
Basket term that captures med
errors and ADR’s.
• ADEs can have different
outcomes: worsening of existing
condition, or lack of expected
• Statistically: 2 ADE’s /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
• High risk med categories:
Psycho tropics, analgesics,
Key Terms cont’
• 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.
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
5. Lack of timely and appropriate monitoring required for
Degree of the
Isolated Pattern Wide-
Jeopardy J K L
Harm G H I
Harm D E F
likely A B C
what are the
Adverse Drug Events
drugs with similar or
what the body does to
What the body does to a drug
• ABSORPTION: bowel surface
decreases with age and gastric
• 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.
Preventable Adverse Drug Effects
Occur at Ordering
Wrong drug choice
Failure to consider drug interactions
Occur at Monitoring
Failure to order specific monitoring needs
Delayed response or failure to respond to signs &
symptoms of toxicity or lab evidence of toxicity
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
1. Indications / reasons for use.
2. Effectiveness, dose.
3. Monitoring: drug regimen, response to
4. Duplication of drug therapy.
5. Presence of Adverse Drug Events
6. Weight history of note.
7. Hydration / intake records of note.
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 /
7. Hydration / intake records of note: evaluation of change in
hydration, fluid, electrolyte balance.
Regulator’s 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
Reactions can be immediate as in anaphylaxis, but generally
requires 5 days of treatment, most show by 12 weeks
• Usually dose dependent.
• Most identified prior to
• Can be due to
drug/drug, and food/drug
• Rarely life threatening
but can produce
• Usually not an extension
of the known drug
• Generally independent of
dose and route of
• Includes idiosyncratic
reactions, immunologic or
• Tend to concentrate in
liver, kidneys, and
Types of Adverse Drug Reactions
1. Drug / Drug Interactions
2. Drug / Nutrient Interactions
3. Allergic Reactions / Hypersensitivity
4. Drug Toxicity
5. Idiosyncratic Reaction
7. DRUG / DISEASE INTERACTIONS
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
• Idiosyncratic Reaction
• DRUG / DISEASE INTERACTIONS: exacerbation of the disease by
the drug (i.e. anti-cholinergic are the most common cause:
glaucoma, BPH, ALTZ, dry eye)
• Monitor drugs with narrow
• Avoid polypharmacy.
• Know, convey, and
• The pharmacist is the
Monthly or more often
(worsening status first 30 days).
• MRR (medication
record review) is
– Resolve MRP’s
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 ADR’s
8. Lack of adherence to drug therapy
Assessing a Possible ADR
1. Review the current medications in use for
associations with symptoms or condition
2. Assess other possible causes for signs and
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
Prevention of Adverse Drug Reactions
1. Consider any new symptom as a possible ADE before
requesting/ administering new medication for the
2. Monitor medication orders for wrong drug choices (high-
risk inappropriate medications, drug–disease and drug–
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.
• Concomitant use of multiple drugs, done by
simply drug counting.
• Administration of more medications than is
• 34% of all drugs prescribed in the United States
are considered unnecessary.
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.
Possible Impacts of Polypharmacy
• Adverse drug reactions
• Drug-drug interactions
• Medication errors made up of non-
• Link to 5% of hospital admission
• Determine all medications being used.
• Identify meds by generic name & drug class.
• Identify the clinical indication of each
• Know the side effect profile of each
• Identify risk factors for an adverse drug
Resident Medication Profile
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
• Use a single drug with an infrequent dosing
Any preventable event that may cause or
lead to inappropriate medication use or
patient harm while the medication is in
control of the health professional.
Pharmaceutical Process Where Drug
Errors are Most Likely to Occur
& Reasons For Potential Solutions
• Why are you using them?
– Interpretive guidelines criteria for use
– Potential benefits
– Potential adverse effects
– Impact on other health conditions
1. Rule out and/or stabilize
2. Check critical lab work
3. Create a list of behavior
disturbances that need
to be improved.
4. Augment therapy if
5. Set realistic goals
6. Establish routine
7. Provide physical clues
8. Talk before touch
9. 1 step commands
10. Allow adequate time for
11. Specify and quantify
1. What is the behavior;
how long does it lasts?
2. Are psychoactive
3. Is behavior creating care
resistance or is care
4. What do you believe are
the potential causes or
contributors to the
5. Can the behavior be
6. If not, why not?
7. Has the use of
8. Have you evaluated the
triggered RAPs and
Questions for Behavior & PA Meds
What are the
What is the
What is the
What is the ease
If easily altered
• Are they receiving psychoactive
• How long?
• Are side effects present?
• Is a reduction program needed or
If not easily altered
• Have physical causes been ruled
• Might there be drug interactions
creating the problem? How do you
• Are they receiving Psych meds? How
long? Has behavior improved? If not,
why not? What now?
Questions for Depression & PA Meds
What are the symptoms ?
If you don’t think these
symptoms are mood
How have you come to
How easily altered?
Are psychoactive, anti-
anxiety, hypnotics in use?
If easily altered & receiving
antidepressant are they a
candidate for reduction?
• If NOT easily altered and
how long has med been
If NOT easily altered and
antidepressant are they a
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
Anti-Anxiety Med Questions
Is this a resident demand or clinical need?
What attempts have been made to address this?
Is there a risk plan in place?
Are there adverse effects that can be tied to other
Is it clinically indicated? If so what are risks, concerns?
Is documentation in place?
Minimize Unnecessary Drug Use
• Drug protocols
• Quality assurance
• Initial and ongoing
• Care Plan
• Gait keeper
• Staff training:
meds used, dose
ranges, side effects,
implication of cognitive
responses leading to
Assessment Tools for Benchmarking Behavior
• Behavior Pathology in Alzheimer's Disease Rating
Scale (BEHAVE-AD), Measures agitation/anxiety,
psychosis, aggression, depression, and activity
• 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
• Functional Assessment Staging (FAST), a diagnosis
tool for determining the stage of dementia
Assessment Tools for Benchmarking Behavior Cont’
• AIMS abnormal involuntary movements
associated with antipsychotic drugs.
• NPI neuropsychiatric inventory assessment of
psychopathology for dementia and other neuro-
• CAM: screens for overall cognitive impairment.
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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Psychoactive Drugs, Physical Restraints,