1. result of concerns about the use of psychotropic medications for people with mr/dd. 2. represents...

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 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

#1-Psychotropic Medication Definition

A psychotropic medication is any drug

prescribed tostabilize or improve mood,

mental status, or behavior.


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.


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


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 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.


When this guideline is not followed, psychotropic

medication becomes chemical restraint or is not being used

in the best interest of the individual.


Excessive includes: inappropriately high doses or inappropriately long periods of time relative to the

diagnosis or condition of concern.

#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).


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.


Substitute for meaningful psychosocial services

includes the use of psychotropic medication to replace more appropriate or necessary

therapeutic, behavioral, or educational interventions.

#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.

#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 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


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.


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.


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


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 InterviewContextual 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

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.

#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)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.

#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.


Index behaviors are also referred

to as “target behaviors,” “signs,”

(observable evidence) or

“symptoms”

(subjective sensations reported by

the patient).


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.


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.


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 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.

#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.

#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.


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.


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.


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.


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.


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.

#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 medication-free status is not possible.

#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

#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.

#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 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.

#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.

#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.

#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.


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 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.


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.

#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.

There may be infrequent exceptions.

Is also referred to as

“duplicate therapy.”

#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.

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

Intraclass Polypharmacy

AntiAnxiety

AntiPsychotic

AntiDepressa

ntStimulant

Sedative/Hypnotic



aConcerta Rozerem


eRestoril


NiravamRisperd

alDesyrel

Dexedrine

Ambien

Interclass PolypharmacyAnti

AnxietyAnti

Psychotic

AntiDepressa

ntStimulant

Sedative/Hypnotic



aConcerta Rozerem


eRestoril


NiravamRisperda

lDesyrel

Dexedrine

Ambien

Interclass PolypharmacyAnti

AnxietyAnti

Psychotic

AntiDepressa

ntStimulant

Sedative/Hypnotic



aConcerta Rozerem

Klonopin

Zyprexa LexaproMetadat

eRestoril


NiravamRisperda

lDesyrel

Dexedrine

Ambien

Chapter VIPathways

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“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.

#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 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.”

#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.

#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 re-evaluation 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 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

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


220 12/20 Depakote increase12/08:

181


118 1/14: 177


67 Cataract Surgery


22


13 4/13 Depakote decrease 4/12:88

Joe Blow – Medication History Chart5/2005 – 7/2007 - Page 3 of 3

DateMedication

Mg/day

AggAvg/

monthComments ABC Score


17 5/12: 62


536/7/07 Urinary Track

Infection


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.

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..

1. result of concerns about the use of psychotropic medications for people with mr/dd. 2. represents...

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inappropriate staff

inappropriate usesubstitute

inappropriate usepunishment

inappropriate useexcessive

inappropriate useinterference

inappropriate usewhen

mental status

peer behavior