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1. Result of concerns about the use of psychotropic medications for people with MR/DD.
2. Represents a coming together of seven professional disciplines: neurology, nursing, pharmacy, pediatrics, psychiatry, psychology, and special education from 11 nations as well as consumers and families
3. Intended uses include:•Consumers-to help formulate questions to physicians and service providers•Agencies-to provide a copy of the book to consulting physicians as a means of strengthening the information on which decisions are made•Physicians-to learn about the observations and opinions of the consensus panel and various committees that wrote the book.
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Chapter 4Guidelines for the Use of Psychotropic Medication
John E. Kalachnik, Bennett L. Leventhal, David H. James, Robert Sovner, Theodore A. Kastner, Kevin Walsh, Steven A. Weisblatt, Margaret G.
Klitzke
11-16-09 Updates via personal contact with John E. Kalachnik
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#1-Psychotropic Medication Definition
A psychotropic medication is any drug
prescribed tostabilize or improve mood,
mental status, or behavior.
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#1-Psychotropic Medication Definition
This includes medications typically classified as
•antipsychotic, •anti-anxiety,
•anti-depressant, •anti-mania, •stimulant, or
•sedative-hypnotic,
but only if they are prescribed to improve mood, mental status, or behavior.
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#1-Psychotropic Medication Definition
This includes other medications not typically classified as psychotropic when such medication is prescribed to improve or stabilize mood, mental
status, or behavior, e.g. Benadryl for sleep
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#1-Psychotropic Medication Definition
This includes herbal or nutritional substances when such substances are used to stabilize or improve mood, mental
status, or behavior.
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#2-Inappropriate Use
Psychotropic medication shall not be usedexcessively, as punishment, for staff convenience, as a substitute for meaningful
psychosocial services, or in quantities that interfere with an
individual’s quality of life.
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#2-Inappropriate Use
When this guideline is not followed, psychotropic
medication becomes chemical restraint or is not being used
in the best interest of the individual.
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#2-Inappropriate Use
Excessive includes: inappropriately high doses or inappropriately long periods of time relative to the
diagnosis or condition of concern.
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#2-Inappropriate UsePunishment includes the use of psychotropic
medication in response to an individual who is exercising his or her legal rights or appropriately responding to inappropriate staff
or peer behavior
(e.g. striking out at a staff member who is improperly confiscating the
individual’s possessions or fighting with a peer who is attempting to assault the
individual).
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#2-Inappropriate Use
Staff convenience includes the use of psychotropic
medication to compensate for poorly trained staff, staff
shortages, poor environmental conditions, or non addressed medical or health concerns.
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#2-Inappropriate Use
Substitute for meaningful psychosocial services
includes the use of psychotropic medication to replace more appropriate or necessary
therapeutic, behavioral, or educational interventions.
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#2-Inappropriate UseInterference with quality of
life
Means that while a specific behavior or condition may be
improved, a decline in functional status or learning
ability compromises the individual to a greater degree
than does the behavior or condition.
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#3-Multidisciplinary Care Plan
Psychotropic medication must be used within a
coordinated multidisciplinary care plan
designed to improve the individual’s quality of life.
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#3-Multidisciplinary Care PlanPsychotropic medication alone
is not a care plan.
A number of professional and responsible parties may be involved in an overall plan
to:•teach skills
•alter environmental stressors•provide other therapy
•provide patient and family education
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#3-Multidisciplinary Care Plan
Multidisciplinary care members must not work in isolation.
Med changes must be communicated to
other team members and coordinated with changes in
life activity or therapy.
Similarly, these changes should be coordinated with med changes.
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#3-Multidisciplinary Care Plan
This does not include stat
orders that by definition constitute emergency
intervention.
This guideline applies to PRN
orders.
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#4-Diagnostic and Functional Assessment
The use of psychotropic medication must be based on:
1) a psychiatric diagnosis, or
2)a specific hypothesis if a psychiatric diagnosis is unclear at the time
resulting from a diagnostic and functional assessment.
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#4-Diagnostic and Functional Assessment
A diagnostic & functional assessment address:
1)Organic and medical pathology2)Psychosocial & environmental conditions3)Health status4)Current medications5)Presence of a psychiatric condition6)History, previous interventions/results7)Functional analysis of behavior
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#4-Diagnostic and Functional Assessment
Functional analysis of behavior addresses:
1)what, if any, antecedents or consequences affect/control a behavior,2)whether behavior represents a deficit or excess, or is situationally inappropriate,3)whether different patterns occur in different situations,4)possible schedule of reinforcement effects.
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Functional Assessment
Functional Assessment examples:
Systematic Manipulation of Variables:Functional Analysis of Behavior
Interviews:Functional Assessment InterviewContextual Assessment Inventory
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#5-Informed Consent
Written informed consent (or documented verbal consent
until written consent can be obtained) must be obtained
from the individual, if competent, or the individual’s guardian
before the use of any psychotropic medication and must be periodically renewed.
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#5-Informed Consent
Information must be presented orally, in
writing, in layperson’s terms, in an
educational manner, and in a manner
ensuring communication.
If not competen
t, the individual must be included
to the degree
possible.
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#5-Informed Consent
Informed consent does not have to be obtained before
the emergency use of psychotropic medication, provided the facility has
obtained general consent for medical emergencies.
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#5-Informed Consent
As long as the guardian has provided written informed consent, the appropriate use of
psychotropic medication should not be affected by a guardian who will not return telephone calls or
attend properly announced reviews.
The time interval for renewing informed consent depends on the individual treatment
phase, but is at least once per year or anytime the risk:benefit ratio changes.
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#5-Informed Consent
Information provided to the person/guardian includes:
1)Diagnosis or hypothesis2)Signs or symptoms expected to be changed 3)How they will be monitored4)Proposed medication5)Risks and side effects (get website)6)An explanation of right to refuse treatment7)An explanation of right to change one’s mind8)Identity of the medication prescriber and how to
contact them.
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#6-Index Behaviors and Empirical Measurement
Index behaviors & quality of life outcomes must be:
1)objectively defined 2)and tracked
using an empirical measurement method(s) in order to evaluate and monitor psychotropic medication efficacy.
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#6-Index Behaviors and Empirical Measurement
Index behaviors are also referred
to as “target behaviors,” “signs,”
(observable evidence) or
“symptoms”
(subjective sensations reported by
the patient).
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#6-Index Behaviors and Empirical Measurement
Recognized empirical measurement methods include one or more of the following: •frequency count, •duration recording, •time sample, •interval recording, •permanent products, and •rating scales as well as •other information and the •subjective observations of an individual who has the ability to provide such information.
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#6-Index Behaviors and Empirical Measurement
A baseline quantification must occur before the non
emergency initiation or addition of any psychotropic medication.
Although a baseline period will vary
depending on the severity of the situation, a reasonable period is 2 to
4 weeks.
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#6-Index Behaviors and Empirical Measurement
Measurement must occur on an ongoing (not necessarily daily)
and consistent basis after the initiation of any
psychotropic medication, especially before and after any dose or drug
change.
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#7-Side Effects Monitoring
The individual must be monitored for side effects on a regular and systematic basis using an accepted methodology
which includes a standardized assessment
instrument.
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#7-Side Effects MonitoringRegular basis
means every person receiving drug
therapy must be assessed:
•at least once every 3-6 months and •after initiation of a new psychotropic medication.
Systematic basis means
some coordinated procedure to
conduct, review, record,
and act on assessment information.
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#7-Side Effects MonitoringA standardized
assessment instrument is used in
addition to any recommended physiological
laboratory assessment, e.g.
lithium level, white blood cell count, etc.
A direct examination should accompany the use of the assessment instrument.
Standardized assessment
instruments mean:
1)A published or recognized scale2)A checklist constructed from standard pharmaceutical or medical references.
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#8-Tardive Dyskinesia Monitoring
If antipsychotic medication or other dopamine-blocking drugs
are prescribed, the individual must be monitored
for tardive dyskinesia on a regular and systematic basis using a standardized assessment
instrument.
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#8-Tardive Dyskinesia Monitoring
Tardive dyskinesia (TD) is a side effect of
antipsychotic medication and metoclopramide
(Reglan). The early detection of TD is critical
to maximize the chances for reversal and to
minimize its impact for individuals for whom
long-term antipsychotic medications
continues to be necessary.
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#8-Tardive Dyskinesia Monitoring
A standardized assessment instrument
means:
the use of a published or recognized
scale, such as the AIMS,
DISCUS, TDRS, or TRIMS.
•Monitoring on a regular basis means at least one every 6 months.
•Systematic basis mean some coordinated procedure to conduct, review, record, and act on assessment information.
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#8-Tardive Dyskinesia Monitoring
If a TD causing drug is discontinued, assessments
should occur 1 and 2 months after
discontinuation to check for withdrawal TD.
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#9-Regular and Systematic Review
Psychotropic Medication must be reviewed
on a regular and systematic basis.
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#9-Regular and Systematic Review
Regular means at
least once
every 3 months
and within 1 month of drug or
dose changes.
Systematic review means a coordinated
procedure between all parties to:
1)share, review, document, and act on information such as index behavior, quality of life, and side effects data and 2)communicate drug, dose, and
non-pharmacological changes.
The review schedul
e should
be outline
d in the care plan.
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#9-Regular and Systematic Review
Data Reviews: Appropriate team
members may vary depending on factors
such as the setting, case, and type of review.
May be done via telephone, reports, etc.
Clinical Review:
The prescribe
r must see the
individual at each clinical review.
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#10-Lowest Optimal Effective Dose
Psychotropic medication must be reviewed on a
periodic and systematic basis to determine whether it is still necessary
or, if it is, whether the lowest optimal effective dose
is prescribed.
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#10-Lowest Optimal Effective Dose
Lowest optimal effective dose (OED)
means the least amount of medication required to improve or stabilize
the problem.
If several psychotropic medications
are prescribed, it
may be possible to reduce the number of
drugs, although a medication-free status is not possible.
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#10-Lowest Optimal Effective DoseSystematic
means a review of variables such as the
1) views of the individual/guardian 2) pattern of index behavior and quality of life data, 3) results of previous properly conducted reductions, 4) comparison of current drugs and dose levels to norms appropriate for the age group, population, diagnosis and treatment phase, 5) new variables since drug initiation or last reduction attempt, 6) current drugs and dose levels compared to previous levels.
Periodic means every
medication review with in-depth
risk:benefit
analysis provided at least
once per year
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#10-Lowest Optimal Effective DoseAlthough there are exceptions, most reductions to determine
the lowest OED must be gradual in nature including the dose
amount and the length of time at dose level.
An annual reduction does NOT need to occur, but review and justification as to the reasons
must occur.
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#11-Frequent Changes
Frequent drug and dose changes
should be avoided.
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#11-Frequent Changes
Medications can take varying
times to work, e.g.
antidepressant drugs may take
2-8 weeks before the full effect is
seen.
Drugs and doses should not be changed in a
reactive manner to index behavior
fluctuation, without
consideration of the disorder being treated, or simply for change’s sake.
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#13-Practices to MinimizeLong-term use of PRN
orders.
Long-term is more than a
few weeks.
PRN orders should be
reserved for behavior
that occurs sporadically
, or unpredictably and does not abate quickly.
This does not mean
the practice may not help a
specific individual
.
Regular use of a
PRN beyond a
few weeks indicates a
need to consider an environmental cause or to review
the treatment
plan.
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#13-Practices to Minimize
Long-term use of
benzodiazepine anti anxiety
medications, such as
diazepam (Valium).
Long-term is more than
3 month
s.
Long-term use of these may lead to diminishing
effectiveness, tolerance,
and pronounced withdrawal reactions.
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#13-Practices to MinimizeUse of
long-acting sedative hypnotic medications, such as chloral
hydrate.
These are associated with behavioral disinhibition
(sudden worsening of behavior) in persons with developmental disabilities.
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#13-Practices to MinimizeLong-
term use of
shorter-acting
sedative-hypnotics, such as temazepa
m (Restoril)
Long-term is more than 14 days.
This does not mean longer use may not be necessary in some cases.
Although preferred over longer-acting
sedative hypnotics, it is
generally recommended to avoid the
long-term use of any sedative
hypnotic medication if
possible.
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#13-Practices to Minimize
Anticholinergic use, such
as benztropine (Cogentin),
without signs of extra
pyramidal side effects (EPSE).
Anticholinergic medication is associated with unpleasant
side effects such as dry mouth, constipation,
blurred vision, and urinary retention; memory loss; and other disadvantages such as
cognitive disturbance.
Although, prophylactic use may be necessary in some
cases.
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#13-Practices to MinimizeLong-term
use of anticholiner
gic medication.
Long-term is more than 3-6 months.
Long-term may be necessary in some cases.
Anticholinergic medication may
no longer be required
•as the body adapts to EPSE or
•when lower antipsychotic medication maintenance levels are reached.
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#13-Practices to Minimize
Use of antipsychotic medication at high doses, e.g. above typical package insert maintenance dose
range.
This does not mean some persons may not respond to high doses, however, this
must be empirically demonstrated.
Individuals who require high-dose
therapy should not be under
medicated, but close review of
such cases should occur because high doses are generally not required on a
long-term basis and may increase
the risk of side effects.
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#12-Polypharmacy
Keep psychotropic medication regimens
as simple as possible in order to enhance compliance
and minimize side effects.
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#12-Polypharmacy
Intraclass polypharmacy(the use of two psychotropic medications
from the same therapeutic class at the same time)
should be avoided.
There may be infrequent exceptions.
Is also referred to as
“duplicate therapy.”
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#12-Polypharmacy
Interclass polypharmacy(the use of 3 or more psychotropic medications from different therapeutic classes at the same
time).
There may be
exceptions…
…such as during the period when a new drug
is being added and a prior
one is being eliminated.
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Intraclass PolypharmacyAnti
AnxietyAnti
Psychotic
AntiDepressa
ntStimulant
Sedative/Hypnotic
BuSpar Abilify Celexa Adderall Lunesta
Ativan HaldolCymbalt
aConcerta Rozerem
Klonopin Zyprexa LexaproMetadat
eRestoril
Vistaril Seroquel Paxil Focalin Sonata
NiravamRisperda
lDesyrel
Dexedrine
Ambien
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Intraclass Polypharmacy
AntiAnxiety
AntiPsychotic
AntiDepressa
ntStimulant
Sedative/Hypnotic
BuSpar Abilify Celexa Adderall Lunesta
Ativan HaldolCymbalt
aConcerta Rozerem
Klonopin Zyprexa LexaproMetadat
eRestoril
Vistaril Seroquel Paxil Focalin Sonata
NiravamRisperd
alDesyrel
Dexedrine
Ambien
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Interclass PolypharmacyAnti
AnxietyAnti
Psychotic
AntiDepressa
ntStimulant
Sedative/Hypnotic
BuSpar Abilify Celexa Adderall Lunesta
Ativan HaldolCymbalt
aConcerta Rozerem
Klonopin Zyprexa LexaproMetadat
eRestoril
Vistaril Seroquel Paxil Focalin Sonata
NiravamRisperda
lDesyrel
Dexedrine
Ambien
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Interclass PolypharmacyAnti
AnxietyAnti
Psychotic
AntiDepressa
ntStimulant
Sedative/Hypnotic
BuSpar Abilify Celexa Adderall Lunesta
Ativan HaldolCymbalt
aConcerta Rozerem
Klonopin
Zyprexa LexaproMetadat
eRestoril
Vistaril Seroquel Paxil Focalin Sonata
NiravamRisperda
lDesyrel
Dexedrine
Ambien
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Chapter VIPathways
to and from Polypharmacy
“…major clinical pitfalls that contribute to
unnecessary psychiatric polypharmacy….”
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#1-Failure to Determine Efficacy
“In my experience, a primary contributor to
the
use of multiple psychopharmacological
agents in individuals with ID is the failure to
empirically determine the efficacy for
existing medication
before adding additional agents.”
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#1-Failure to Determine Efficacy“It is difficult to imagine
how an individual could
be receiving 4, 5, or
more psychotropic
medications and still be
exhibiting high rates of
aggression and/or self-
injurious behavior if they
were all effective for the
individual’s underlying
disorder.”
Chapter 3 identifies statistical methods to go
about challenging the efficacy of medication.
These methods are beyond the scope of this
presentation.
However, advocates can easily inquire from the
prescriber, about how this may apply to any person(s)
to which services are being provided.
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#2-Reluctance to Accept a Partial Response
“In most cases, the symptoms of
major mental illness
will diminish
when the appropriate
psychotropic medication is utilized,
but the symptoms
will NOT entirely disappear.”
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#2-Reluctance to Accept a Partial Response
“…clinical teams often do not appreciate the
chronicity of these disorders and may
advocate for additional medications in the
belief that the total eradication of symptoms
is possible.”
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#3-Bipolar
“The diagnostic hallmark of bipolar disorder is a significant change in mental status
involving periods of euthymia, depression, and mania or hypomania. This fluctuating
course can easily contribute to polypharmacy.”
“…manic-depressive illness …rarely goes into complete remission as a result of
pharmacological treatment.”
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#3-Bipolar
“If an individual with this diagnosis
ceases to manifest any symptoms
of their cyclical disorder, it is probably
more likely
that there has been a
spontaneous remission of the disorder.”
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#3-Failure to Distinguish Between Signal and Noise
“…a failure to distinguish between signal and noise can lead the clinical team to
respond to “blips” and “clusters” of behavior as if they represented a
significant trend that could represent a change in the underlying disorder.“
Signal (trend) = steady increase or decrease in the frequency of a monitored
symptomatic behavior that occurs over a period of
several weeks or months.
Noise (blips) = a noticeable change in
frequency which occurs for no observable reason and is
transient.
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#3-Failure to Distinguish Between Signal and Noise
Mikkelsen’s remedy for this type of
error
is to develop a data collection system
that provides a lengthy historical
perspective, specifically one that
identifies the degree of variation
that has occurred in the past.
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#4-Failure to Address Environmental Issues
“Turning a blind eye to environment
factors and/or failing to fully
investigate them before prescribing
psychotropic medication will only
perpetuate the problem.”
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#4-Failure to Address Environmental Issues
“You cannot solve fundamentally flawed
environmentally precipitated behavior problems
with psychotropic medications.”
What the prescriber should know:
•Number of housemates with which that the person lives •Characteristics of those people•Size and/or configuration of the person’s home•Staff ratios and rate of staff turnover
Is a team member who knows the person well present?
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#5-Failure to Reassess the Psychiatric Diagnosis
…physicians frequently formulate their diagnosis quickly and on relatively little clinical information.
A cognitive bias is then formed.
This leads to the exclusion or minimization of symptoms and other data that would contraindicate the original diagnosis.
This process contributes to polypharmacy, as it leads to the implementation of psychopharmacological
interventions that may not be effective.
The problem is then compounded by the
addition of subsequent multiple medications from the same class, rather than
a re-evaluation of the validity of the psychiatric
diagnosis.
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#6 Inaccurate or Biased Reporting of Data
“If a clear, concise visual presentation
of the behavioral data is not available,
the prescriber may default to an
acceptance of the subjective opinion
of whichever staff member happens to
accompany the patient on that day.”
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#5 Inaccurate or Biased Reporting of Data
Provide the medication prescriber the
information she needs in a straight
forward manner that is easy to interpret:
Medication History Chart
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Joe Blow – Medication History Chart5/2005 – 7/2007 Page 1 of 3
DateMedication
Mg/day
AggAvg/
monthComments
ABC Score
5/2005 Clozapine 600 - 5/25/05 Admitted to WRC 5/25: 154
6/2005 Clozapine 650 124 6/25 Clozapine increase 6/25: 148
7/2005 Clozapine 650 143 7/22: 162
8/2005 Clozapine 700 310 8/23 Clozapine increase 8/23: 152
9/2005 Clozapine 700 337 9/25: 167
10/2006 Clozapine 700 366
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Joe Blow – Medication History Chart5/2005 – 7/2007 - Page 2 of 3
DateMedication
Mg/day
AggAvg/
monthComments
ABC Score
11/2005Clozapine 700Depakote 2000
440 11/5/05 Depakote initiated11/05:
172
12/2005Clozapine 700Depakote 2500
220 12/20 Depakote increase12/08:
181
1/2006Clozapine 700Depakote 2500
118 1/14: 177
2/2006Clozapine 700Depakote 2500
67 Cataract Surgery
3/2006Clozapine 700Depakote 2500
22
4/2006Clozapine 700Depakote 2000
13 4/13 Depakote decrease 4/12:88
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Joe Blow – Medication History Chart5/2005 – 7/2007 - Page 3 of 3
DateMedication
Mg/day
AggAvg/
monthComments ABC Score
5/2007Clozapine 700Depakote 2000
17 5/12: 62
6/2007Clozapine 700Depakote 2000
536/7/07 Urinary Track
Infection
7/2007Clozapine 700Depakote 2000
3Most optimal data
period in recent history7/23: 42
*ABC Aberrant Behavior Checklist assessment, to be completed at the time of drug changes, 30 days later, or quarterly in the absence of any drug changes.
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Take Home Message:
Be familiar with these guidelines.
Consider how they apply to
the persons you serve.
Provide the prescriber
with information
that will allow
him/her to make data
based decisions..