Transcript Day 2 Psychotropic Medication

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.
Chapter 4
Guidelines 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
#1-Psychotropic Medication Definition
A psychotropic medication
is any drug
prescribed to
stabilize or improve mood,
mental status,
or behavior.
#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.
#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
#1-Psychotropic Medication Definition
This includes herbal or
nutritional substances when
such substances are used to
stabilize or improve mood,
mental status, or behavior.
#2-Inappropriate Use
Psychotropic medication shall not be used
 excessively,
 as punishment,
 for staff convenience,
 as a substitute for meaningful psychosocial
services,
 or in quantities that interfere with an individual’s
quality of life.
#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.
#2-Inappropriate Use
Excessive
includes: inappropriately high doses
or inappropriately long periods of
time relative to the diagnosis or
condition of concern.
#2-Inappropriate Use
Punishment
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).
#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.
#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.
#2-Inappropriate Use
Interference 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.
#3-Multidisciplinary Care Plan
Psychotropic medication
must be used within a
coordinated multidisciplinary care plan
designed to improve
the individual’s quality of life.
#3-Multidisciplinary Care Plan
Psychotropic 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
#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.
#3-Multidisciplinary Care Plan
This does not
include stat
orders that by
definition
constitute
emergency
intervention.
This guideline
applies to PRN
orders.
#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.
#4-Diagnostic and Functional Assessment
A diagnostic & functional assessment
address:
1) Organic and medical pathology
2) Psychosocial & environmental conditions
3) Health status
4)Current medications
5) Presence of a psychiatric condition
6)History, previous interventions/results
7) Functional analysis of behavior
#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.
Functional Assessment
Functional Assessment examples:
Systematic Manipulation of Variables:
Functional Analysis of Behavior
Interviews:
Functional Assessment Interview
Contextual Assessment Inventory
#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.
#5-Informed Consent
If not
competent,
the
individual
must be
included to
the degree
possible.
Information must be
presented orally, in
writing, in layperson’s
terms, in an educational
manner, and in a manner
ensuring communication.
#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.
#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.
#5-Informed Consent
Information provided to the person/guardian includes:
1)
2)
3)
4)
5)
6)
7)
8)
Diagnosis or hypothesis
Signs or symptoms expected to be changed
How they will be monitored
Proposed medication
Risks and side effects (get website)
An explanation of right to refuse treatment
An explanation of right to change one’s mind
Identity of the medication prescriber and how to contact
them.
#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.
#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).
#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.
#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.
#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.
#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.
#7-Side Effects Monitoring
Regular 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.
#7-Side Effects Monitoring
A standardized
assessment instrument is
used in addition to any
recommended
physiological laboratory
assessment, e.g. lithium
level, white blood cell
count, etc.
Standardized assessment
instruments mean:
1) A published or
recognized scale
2) A checklist constructed
from standard
pharmaceutical or
medical references.
A direct examination should accompany the
use of the assessment instrument.
#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.
#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.
#8-Tardive Dyskinesia Monitoring
A standardized
assessment
instrument
means:
•Monitoring on a
regular basis means at
least one every 6
months.
the use of a
published or
recognized scale,
such as the AIMS,
DISCUS, TDRS, or
TRIMS.
•Systematic basis mean
some coordinated
procedure to conduct,
review, record, and act
on assessment
information.
#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.
#9-Regular and Systematic Review
Psychotropic Medication
must be reviewed
on a regular and systematic basis.
#9-Regular and Systematic Review
The
review
schedule
should
be
outlined
in the
care plan.
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.
#9-Regular and Systematic Review
Clinical
Review:
The
prescriber
must see
the
individual
at each
clinical
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.
#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.
#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 medicationfree status is not
possible.
#10-Lowest Optimal Effective Dose
Periodic
means
every
medication
review with
in-depth
risk:benefit
analysis
provided at
least once
per year
Systematic
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.
#10-Lowest Optimal Effective Dose
Although 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.
#11-Frequent Changes
Frequent
drug and dose changes
should be avoided.
#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.
#13-Practices to Minimize
Longterm 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.
Regular use
of a PRN
beyond a few
weeks
indicates a
need to
consider an
environment
al cause or to
review the
treatment
plan.
This does
not mean
the practice
may not
help a
specific
individual.
#13-Practices to Minimize
Long-term
use of
benzodiazepine
anti anxiety
medications,
such as diazepam
(Valium).
Longterm is
more
than
3
months.
Long-term use
of these may
lead to
diminishing
effectiveness,
tolerance, and
pronounced
withdrawal
reactions.
#13-Practices to Minimize
Use 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.
#13-Practices to Minimize
Long-term
use of
shorteracting
sedativehypnotics,
such as
temazepam
(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 longterm use of any
sedative hypnotic
medication if
possible.
#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.
#13-Practices to Minimize
Long-term
use of
anticholinergic
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.
#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 longterm basis and may
increase the risk of
side effects.
#12-Polypharmacy
Keep psychotropic medication regimens
as simple as possible
in order to enhance compliance
and minimize side effects.
#12-Polypharmacy
Intraclass polypharmacy
(the use of two psychotropic medications from the
same therapeutic class at the same time)
should be avoided.
Is also referred to as
“duplicate therapy.”
There may be
infrequent
exceptions.
#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.
Let’s look at
some examples of
each.
Intraclass Polypharmacy
Anti
Anxiety
Anti
Psychotic
Anti
Depressant
Stimulant
Sedative/
Hypnotic
BuSpar
Abilify
Celexa
Adderall
Lunesta
Ativan
Haldol
Cymbalta
Concerta
Rozerem
Klonopin
Zyprexa
Lexapro
Metadate
Restoril
Vistaril
Seroquel
Paxil
Focalin
Sonata
Niravam
Risperdal
Desyrel
Dexedrine
Ambien
Intraclass Polypharmacy
Anti
Anxiety
Anti
Psychotic
Anti
Depressant
Stimulant
Sedative/
Hypnotic
BuSpar
Abilify
Celexa
Adderall
Lunesta
Ativan
Haldol
Cymbalta
Concerta
Rozerem
Klonopin
Zyprexa
Lexapro
Metadate
Restoril
Vistaril
Seroquel
Paxil
Focalin
Sonata
Niravam
Risperdal
Desyrel
Dexedrine
Ambien
Interclass Polypharmacy
Anti
Anxiety
Anti
Psychotic
Anti
Depressant
Stimulant
Sedative/
Hypnotic
BuSpar
Abilify
Celexa
Adderall
Lunesta
Ativan
Haldol
Cymbalta
Concerta
Rozerem
Klonopin
Zyprexa
Lexapro
Metadate
Restoril
Vistaril
Seroquel
Paxil
Focalin
Sonata
Niravam
Risperdal
Desyrel
Dexedrine
Ambien
Interclass Polypharmacy
Anti
Anxiety
Anti
Psychotic
Anti
Depressant
Stimulant
Sedative/
Hypnotic
BuSpar
Abilify
Celexa
Adderall
Lunesta
Ativan
Haldol
Cymbalta
Concerta
Rozerem
Klonopin
Zyprexa
Lexapro
Metadate
Restoril
Vistaril
Seroquel
Paxil
Focalin
Sonata
Niravam
Risperdal
Desyrel
Dexedrine
Ambien
Chapter VI
Pathways
to and from
Polypharmacy
“…major clinical pitfalls
that contribute to
unnecessary psychiatric
polypharmacy….”
#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.”
#1-Failure to Determine Efficacy
10
600
9
Behavior Rate
7
400
6
5
300
4
200
3
2
100
1
0
0
Jan
Feb
Behavior
Mar
Apr
Drug #1
May
Drug #2
June
Drug #3
July
Drug Dose
500
8
#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 selfinjurious 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.
#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.”
#2 - Reluctance to Accept Partial Response
10
600
9
Behavior Rate
7
400
6
5
300
4
200
3
2
100
1
0
0
Jan
Feb
Mar
Behavior
Apr
Drug #1
May
Drug #2
June
Drug Dose
500
8
#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.”
#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.”
Medications Added During Manic States
10
600
9
Behavior Rate
7
400
6
5
300
4
200
3
2
100
1
0
0
Jan
Feb
Mar
April
Behavior
May
Drug #1
June
July
Drug #2
Aug
Drug Dose
500
8
#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.”
#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.
Failure to Distinguish Noise from Signal
10
600
9
Behavior Rate
7
400
6
5
300
4
200
3
2
100
1
0
0
Jan
Feb
Mar
Behavior
Apr
Drug #1
May
June
Drug Dose
500
8
#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.
#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.”
#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?
#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 reevaluation of the validity of the
psychiatric diagnosis.
#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.”
#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
Joe Blow – Medication History Chart
5/2005 – 7/2007 Page 1 of 3
Date
Medication
Mg/day
Agg
Avg/
month
Comments
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
8/2005
Clozapine 700
310
9/2005
Clozapine 700
337
10/2006
Clozapine 700
366
7/22: 162
8/23 Clozapine increase
8/23: 152
9/25: 167
Joe Blow – Medication History Chart
5/2005 – 7/2007 - Page 2 of 3
Date
Medication
Mg/day
Agg
Avg/
month
Comments
ABC Score
11/2005
Clozapine 700
Depakote 2000
440
11/5/05 Depakote initiated
11/05: 172
12/2005
Clozapine 700
Depakote 2500
220
12/20 Depakote increase
12/08: 181
1/2006
Clozapine 700
Depakote 2500
118
2/2006
Clozapine 700
Depakote 2500
67
3/2006
Clozapine 700
Depakote 2500
22
4/2006
Clozapine 700
Depakote 2000
13
1/14: 177
Cataract Surgery
4/13 Depakote decrease
4/12:88
Joe Blow – Medication History Chart
5/2005 – 7/2007 - Page 3 of 3
Date
Medication
Mg/day
Agg
Avg/
month
5/2007
Clozapine 700
Depakote 2000
17
6/2007
Clozapine 700
Depakote 2000
53
6/7/07 Urinary Track
Infection
7/2007
Clozapine 700
Depakote 2000
3
Most optimal data period in
recent history
Comments
ABC Score
5/12: 62
7/23: 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.
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..