Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 390 - MEDICALLY COMPLEX FOR THE DEVELOPMENTALLY DISABLED FACILITIES CODE › Subpart P - DAY CARE PROGRAMS › Appendix C - Guidelines for the Use of Various Drugs

Current through Register Vol. 48, No. 28, July 12, 2024
A. Long-Acting Benzodiazepine Drugs
Long-acting benzodiazepine drugs should not be
				  used in residents unless an attempt with a shorter-acting drug (i.e., those
				  listed under B. Benzodiazepine or Other Anxiolytic/Sedative Drugs, and under C.
				  Drugs Used for Sleep Induction) has failed.
After an attempt with a shorter-acting
				  benzodiazepine drug has failed, a long-acting benzodiazepine drug should be
				  used only if:
1. Evidence exists that other possible reasons for
				  the resident's distress have been considered and ruled out;
2. Its use results in maintenance or improvement
				  in the resident's functional status;
3. Daily use is less than four continuous months
				  unless an attempt at a gradual dose reduction is unsuccessful; and
4. Its use is less than, or equal to, the
				  following listed total daily doses unless higher doses (as evidenced by the
				  resident's response and/or the resident's clinical record) are necessary for
				  the maintenance or improvement in the resident's functional status.
EXAMPLES OF LONG-ACTING
							 BENZODIAZEPINES (not maximum doses)
Generic
Brand
Daily Oral Dosage
Flurazepam
(Dalmane)
15mg
Chlordiazepoxide
(Librium)
20mg
Clorazepate
(Tranxene)
15mg
Diazepam
(Valium)
5mg
Clonazepam
(Klonopin)
1.5 mg
Quazepam
(Doral)
7.5 mg
Halazepam
(Paxipam)
40mg
NOTES:
When diazepam is used for neuromuscular syndromes
				  (e.g., cerebral palsy, tardive dyskinesia or seizure disorders), this Guideline
				  does not apply.
When long-acting benzodiazepine drugs are being
				  used to withdraw residents from short-acting benzodiazepine drugs, this
				  Guideline does not apply.
When clonazepam is used in bi-polar disorders,
				  management of tardive dyskinesia, nocturnal myoclonus or seizure disorders,
				  this Guideline does not apply.
The daily doses listed under Long-Acting
				  Benzodiazepines are doses (usually administered in divided doses) for
				  "geriatric" or "elderly" residents. The facility is encouraged to initiate
				  therapy with lower doses and when necessary only gradually increase doses. The
				  facility may exceed these doses if it provides evidence to show why it was
				  necessary for the maintenance or improvement in the resident's functional
				  status.
For drugs in this category, a gradual dose
				  reduction should be attempted at least twice within one year before one can
				  conclude that the gradual dose reduction is "clinically
				  contraindicated."
B. Benzodiazepine or other Anxiolytic/Sedative Drugs
Use of the listed Anxiolytic/Sedative drugs for
				  purposes other than sleep induction should only occur if:
1. Evidence exists that other possible reasons for
				  the resident's distress have been considered and ruled out;
2. Use results in a maintenance or improvement in
				  the resident's functional status;
3. Daily use (at any dose) is less than four
				  continuous months unless an attempt at a gradual dose reduction is
				  unsuccessful;
4. Use is for one of the following indications as
				  defined by the Diagnostic and Statistical Manual of Mental Disorders; Fourth
				  Edition (DSM-IV):
Generalized anxiety disorder;
Organic mental syndromes (now called dementia,
				  delirium and amnestic and other "cognitive disorders" by DSM-IV) with
				  associated agitated states which are quantitatively and objectively documented,
				  which are persistent and not due to preventable reasons and which constitute
				  sources of distress or dysfunction to the resident or represent a danger to the
				  resident or others;
Panic disorder;
Symptomatic anxiety that occurs in residents with
				  another diagnosed psychiatric disorder (e.g., depression, adjustment disorder);
				  and
5. Use is equal to or less than the following
				  listed total daily doses, unless higher doses (as evidenced by the resident's
				  response and/or the resident's clinical record) are necessary for the
				  improvement or maintenance in the resident's functional status.
EXAPLES OF SHORT-ACTING BENZODIAZEPINES (not maximum
							 doses)
Generic
Brand
Daily Oral Dosage
Lorazepam
(Ativan)
2mg
Oxazepam
(Serax)
30mg
Alprazolam
(Xanax)
0.75 mg
EXAMPLES OF OTHER ANXIOLYTIC AND SEDATIVE
							 DRUGS
Generic
Brand
Daily Oral Dosage
Diphenhydramine
(Benadryl)
50mg
Hydroxyzine
(Atarax, Vistaril)
50mg
Chloral Hydrate
(Many Brands)
750mg
NOTES:
This documentation is often referred to as
				  "behavioral monitoring charts" and is necessary to assist in: (a) assessing
				  whether the resident's behavioral symptom is in need of some form of
				  intervention, b) determining whether the behavioral symptom is transitory or
				  permanent, (c) relating the behavioral symptom to other events in the
				  resident's life in order to learn about potential causes (e.g., death in the
				  family, not adhering to the resident's customary daily routine), (d) ruling out
				  environmental causes such as excessive heat, noise, overcrowding, etc., (e)
				  ruling out medical causes such as pain, constipation, fever, infection.
The daily doses listed under Short-Acting
				  Benzodiazepines are doses (usually administered in divided doses) for
				  "geriatric" or "elderly" residents. The facility is encouraged to initiate
				  therapy with lower doses and when necessary only gradually increase doses. The
				  facility may exceed these doses if it provides evidence to show why it was
				  necessary for the maintenance or improvement in the resident's functional
				  status.
For drugs in this category, a gradual dose
				  reduction should be attempted at least twice within one year before one can
				  conclude that a gradual dose reduction is "clinically contraindicated."
Diphenhydramine, hydroxyzine and chloral hydrate
				  are not necessarily drugs of choice for treatment of anxiety disorders. They
				  are only listed here in the event of their potential use.
C. Drugs Used for Sleep Induction
Drugs used for sleep induction should only be used
				  if:
1. Evidence exists that other possible reasons for
				  insomnia (e.g., depression, pain, noise, light, caffeine) have been ruled
				  out;
2. The use of a drug to induce sleep results in
				  the maintenance or improvement of the resident's functional status;
3. Daily use of the drug is less than ten
				  continuous days unless an attempt at a gradual dose reduction is
				  unsuccessful;
4. The dose of the drug is equal to or less than
				  the following listed doses unless higher doses (as evidenced by the resident's
				  response and/or the resident's clinical record) are necessary for maintenance
				  or improvement in the resident's functional status.
EXAMPLES OF HYPNOTIC DRUGS (not
							 maximum doses)
Generic
Brand
Oral Dosage
Temazepam
(Restoril)
7.5mg
Triazolam
(Halcion)
0.125 mg
Lorazepam
(Ativan)
1mg
Oxazepam
(Serax)
15mg
Alprazolam
(Xanax)
0.25 mg
Estazolam
(ProSom)
0.5 mg
Diphenhydramine
(Benadryl)
25mg
Hydroxyzine
(Atarax, Vistaril)
50mg
Chloral Hydrate
(Many Brands)
500mg
Zolpiden
(Ambien)
5mg
NOTES:
Diminished sleep in the elderly is not necessarily
				  pathological.
The doses listed are doses for "geriatric" or
				  "elderly" residents. The facility is encouraged to initiate therapy with lower
				  doses and when necessary only gradually increase doses. The facility may exceed
				  these doses if it provides evidence to show why it was necessary for the
				  maintenance or improvement in the resident's functional status.
Diphenhydramine, hydroxyzine, and chloral hydrate
				  are not necessarily drugs of choice for sleep disorders. They are listed here
				  only in the event of their potential use.
For drugs in this category, a gradual dose
				  reduction should be attempted at least three times within six months before one
				  can conclude that a gradual dose reduction is "clinically
				  contraindicated."
D. Miscellaneous Hypnotic/Sedative/Anxiolytic Drugs
The initiation of the following
				  hypnotic/sedative/anxiolytic drugs should not occur in any dose for any
				  resident. (See Notes for exceptions.) Residents currently using these drugs or
				  residents admitted to the facility while using these drugs should receive
				  gradual dose reductions as part of a plan to eliminate or modify the symptoms
				  for which they are prescribed. A gradual dose reduction should be attempted at
				  least twice within one year before one can conclude that the gradual dose
				  reduction is clinically contraindicated. Newly admitted residents using these
				  drugs may have a period of adjustment before a gradual dose reduction is
				  attempted.
(Caution: The rapid withdrawal of these
				  drugs might result in severe physiological withdrawal symptoms.)
EXAMPLES OF BARBITURATES
Generic
Brand
Amobarbital
(Amytal)
Amobarbital-Secobarbital
(Tuinal)
Butabarbital
(Butisol, others)
Pentobarbital
(Nembutal)
Secobarbital
(Seconal)
Phenobarbital
(Many Brands)
Barbiturates with other drugs
(e.g., Fiorinal)
EXAMPLES OF MISCELLANEOUS
							 HYPNOTIC/SEDATIVE/ANXIOLYTICS
Generic
Brand
Ethchlorvynol
(Placidyl)
Glutethimide
(Doriden)
Meprobamate
(Equinal, Miltown)
Methprylon
(Noludar)
Paraldehyde
(Many Brands)
NOTES:
Any sedative drug is excepted from this Guideline
				  when used as a single dose sedative for dental or medical procedures.
Phenobarbital is excepted from this Guideline when
				  used in the treatment of seizure disorders.
When Miscellaneous Hypnotic/Sedative/Anxiolytic
				  Drugs are used outside these Guidelines, they may be unnecessary drugs as a
				  result of inadequate indications for use.
E. Antipsychotic Drugs
The following examples of antipsychotic drugs
				  should not be used in excess of the listed doses for residents with organic
				  mental syndromes (now called dementia, delirium, and amnestic and other
				  "cognitive disorders" by DSM-IV) unless higher doses (as evidenced by the
				  resident's response or the resident's clinical record) are necessary to
				  maintain or improve the resident's functional status.
EXAMPLES OF ANTIPSYCHOTIC DRUGS FOR
							 RESIDENTS WITH ORGANIC MENTAL SYNDROMES (not maximum doses)
Generic
Brand
Daily Oral Dosage
Chlorpromazine
(Thorazine)
75mg
Promazine
(Sparine)
150mg
Triflupromazine
(Vesprin)
20mg
Thioridazine
(Mellaril)
75mg
Mesoridazine
(Serentil)
25mg
Acetophenazine
(Tindal)
20mg
Perpnenazine
(Trilafon)
8mg
Fluphenazine
(Prolixin, Permitil)
4mg
Trifluoperazine
(Stelazine)
8mg
Chlorprothixene
(Taractan)
75mg
Thiothixene
(Navane)
7mg
Haloperidol
(Haldol)
4mg
Molindone
(Moban)
10mg
Loxapine
(Loxitane)
10mg
Clozapine
(Clozaril)
50mg
Prochlorperazine
(Compazine)
10mg
Risperidone
(Resperdal)
4mg
NOTES:
The doses listed are daily doses (usually
				  administered in divided doses) for residents with organic mental syndromes (now
				  called dementia, delirium, and amnestic and other "cognitive disorders" by
				  DSM-IV). The facility is encouraged to initiate therapy with lower doses and
				  when necessary only gradually increase doses. The facility may exceed these
				  doses if it provides evidence to show why it is necessary for the maintenance
				  or improvement in the resident's functional status.
The "specific conditions" for use of antipsychotic
				  drugs are listed under this Guideline under G.
The dose of prochlorperazine may be exceeded for
				  short term (seven day) treatment of nausea and vomiting. Residents with nausea
				  and vomiting secondary to cancer or cancer chemotherapy can also be treated
				  with higher doses for longer periods of time.
When antipsychotic drugs are used outside these
				  Guidelines, they may be deemed unnecessary drugs as a result of excessive
				  doses.
F. Monitoring for Antipsychotic Drug Side Effects
The facility assures that residents who are
				  undergoing antipsychotic drug therapy receive adequate monitoring for
				  significant side effects of such therapy with emphasis on the following:
1. Tardive dyskinesia;
2. Postural (orthostatic) hypotension;
3. Cognitive/behavior impairment;
4. Akathisia; and
5. Parkinsonism.
When antipsychotic drugs are used without
				  monitoring for these side effects, they may be unnecessary drugs because of
				  inadequate monitoring.
G. Use of Antipsychotic Drugs
Antipsychotic drugs should not be used unless the
				  clinical record documents that the resident has one or more of the following
				  "specific conditions":
1. Schizophrenia;
2. Schizo-affective disorder;
3. Delusional disorder;
4. Psychotic mood disorders (including mania and
				  depression with psychotic features);
5. Acute psychotic episodes;
6. Brief reactive psychosis;
7. Schizophreniform disorder;
8. Atypical psychosis;
9. Tourette's disorder;
10. Huntington's disease;
11. Organic mental syndromes (now called dementia,
				  delirium, and amnestic and other "cognitive disorders" by DSM-IV) with
				  associated psychotic and/or agitated behaviors:
Which have been quantitatively (number of
				  episodes) and objectively (e.g., biting, kicking, scratching) documented. This
				  documentation is necessary to assist in: (a) assessing whether the resident's
				  behavioral symptom is in need of some form of intervention, (b) determining
				  whether the behavioral symptom is transitory or permanent, (c) relating the
				  behavioral symptom to other events in the resident's life in order to learn
				  about potential causes (e.g., death in the family, not adhering to the
				  resident's customary daily routine), (d) ruling out environmental causes such
				  as excessive heat, noise, overcrowding, (e) ruling out medical causes such as
				  pain, constipation, fever, infection;
Which are persistent;
Which are not caused by preventable reasons;
				  and
Which are causing the resident to:
Present a danger to her/himself or to
				  others,
Continuously cry, scream, yell, or pace if these
				  specific behaviors cause an impairment in functional capacity, or
Experience psychotic symptoms (hallucinations,
				  paranoia, delusions) not exhibited as dangerous behaviors or as crying,
				  screaming, yelling, or pacing but which cause the resident distress or
				  impairment in functional capacity; or
12. Short term (seven days) symptomatic treatment
				  of hiccups, nausea, vomiting or pruritus. Residents with nausea and vomiting
				  secondary to cancer or cancer chemotherapy can be treated for longer periods of
				  time.
Antipsychotics should not be used if one or more
				  of the following is/are the only indication:
1. Wandering,
2. Poor self care,
3. Restlessness,
4. Impaired memory,
5. Anxiety,
6. Depression (without psychotic features),
7. Insomnia,
8. Unsociability,
9. Indifference to surroundings,
10. Fidgeting,
11. Nervousness,
12. Uncooperativeness, or
13. Agitated behaviors which do not represent
				  danger to the resident or others.
H. Antipsychotic Drug Gradual Dose Reduction
Residents must, unless clinically contraindicated,
				  have gradual dose reductions of the antipsychotic drug. The gradual dose
				  reduction should be under close supervision. If the gradual dose reduction is
				  causing an adverse effect on the resident and the gradual dose reduction is
				  discontinued, documentation of this decision and the reasons for it should be
				  included in the clinical record. Gradual dose reductions consist of tapering
				  the resident's daily dose to determine if the resident's symptoms can be
				  controlled by a lower dose or to determine if the dose can be eliminated
				  altogether.
"Behavioral interventions" means modification of
				  the resident's behavior or the resident's environment, including staff
				  approaches to care, to the largest degree possible to accommodate the
				  resident's behavioral symptoms.
"Clinically contraindicated" means that a resident
				  need not undergo a "gradual dose reduction" or "behavioral intervention" if the
				  resident has a "specific condition" (as listed in these Guidelines under G,
				  1-11) and has a history of recurrence of psychotic symptoms (e.g., delusions,
				  hallucinations) which have been stabilized with a maintenance dose of an
				  antipsychotic drug without incurring significant side effects (e.g., tardive
				  dyskinesia). In residents with organic mental syndromes (now called dementia,
				  delirium, and amnestic and other "cognitive disorders" by DSM-IV), "clinically
				  contraindicated" means that a gradual dose reduction has been attempted twice
				  in one year and that attempt resulted in the return of symptoms for which the
				  drug was prescribed to a degree that a cessation in the gradual dose reduction,
				  or a return to previous dose levels, was necessary. The resident's physician
				  provides a justification why the continued use of the drug and the dose of the
				  drug is clinically appropriate. This justification should include: (a) a
				  diagnosis, but not simply a diagnostic label or code, but the description of
				  symptoms, (b) a discussion of the differential psychiatric and medical
				  diagnosis (e.g., why the resident's behavioral symptom is thought to be a
				  result of a dementia with associated psychosis and/or agitated behaviors, and
				  not the result of an unrecognized painful medical condition or a psychosocial
				  or environmental stressor), (c) a description of the justification for the
				  choice of a particular treatment, or treatments, and (d) a discussion of why
				  the present dose is necessary to manage the symptoms of the resident. This
				  information need not necessarily be in the physician's progress notes, but must
				  be a part of the resident's clinical record.
I. Antidepressant Drugs
The facility is not required to use behavioral
				  monitoring charts when antidepressant drugs are used. "Behavioral monitoring
				  charts" include such records as quantitative evidence (number of episodes) and
				  objective evidence (e.g., withdrawn behavior such as the resident staying in
				  his/her room, refusal to speak, etc.) of patient behavior necessitating the use
				  of the antidepressant drugs. The following is a list of commonly used
				  antidepressant drugs:
EXAMPLES OF ANTIDEPRESSANT
							 DRUGS
Generic
Brand
Amitriptyline
(Elavil)
Amoxapine
(Asendin)
Desipramine
(Norpramin, Pertofrane)
Doxepin
(Sinequan)
Imipramine
(Tofranil)
Maprotiline
(Ludiomil)
Nortriptyline
(Aventyl, Panelor)
Protriptyline
(Vivactil)
Trimipramine
(Surmontil)
Fluoxetine
(Prozac)
Sertaline
(Zoloft)
Trazodone
(Desyrel)
Clomipramine
(Anafranil)
Paroxetine
(Paxil)
Bupropion
(Wellbutrin)
Isocarboxazid
(Marplan)
Phenelzine
(Nardil)
Tranylcypromine
(Parnate)
Venlafaxine
(Effexor)
Nefazadone
(Serzone)
Fluvoxamine
(Luvox)
J. Exceptions to These Guidelines
The facility shall have the opportunity to provide
				  a rationale for the use of drugs prescribed outside these Guidelines. The
				  facility may not justify the use of a drug prescribed outside these Guidelines
				  solely on the basis of "the doctor ordered it." The rationale must be based on
				  sound risk-benefit analysis of the resident's symptoms and potential adverse
				  effects of the drug.
The unnecessary drug criterion of "adequate
				  indications for use" does not simply mean that the physician's order must
				  include a reason for using the drug (although such order writing is
				  encouraged). It means that the resident lacks a valid clinical reason for use
				  of the drug as evidenced by the evaluation of some, but not necessarily all, of
				  the following: resident assessment, plan of care, reports of significant
				  change, progress notes, laboratory reports, professional consults, drug orders,
				  observation and interview of the resident, and other information.
In determining whether an antipsychotic drug is
				  without a "specific condition" or that "gradual dose reduction and behavioral
				  interventions" have not been performed, the facility shall justify why using
				  the drug outside these Guidelines is in the best interest of the
				  resident.
Examples of evidence that would support a
				  justification of why a drug is being used outside these Guidelines but in the
				  best interests of the resident may include, but are not limited to:
1. A physician's note indicating, for example,
				  that the dosage, duration, indication, and monitoring are clinically
				  appropriate, and the reasons why they are clinically appropriate; this note
				  should demonstrate that the physician has carefully considered the risk/benefit
				  to the resident in using drugs outside these Guidelines;
2. A medical or psychiatric consultation or
				  evaluation (e.g., Geriatric Depression Scale) that confirms the physician's
				  judgment that use of a drug outside these Guidelines is in the best interest of
				  the resident;
3. Physician, nursing, or other health
				  professional documentation indicating that the resident is being monitored for
				  adverse consequences or complications of the drug therapy;
4. Documentation confirming that previous attempts
				  at dosage reduction have been unsuccessful;
5. Documentation (such as MDS documentation)
				  showing resident's subjective or objective improvement, or maintenance of
				  function while taking the medication;
6. Documentation showing that a resident's decline
				  or deterioration is evaluated by the interdisciplinary team to determine
				  whether a particular drug, or a particular dose, or duration of therapy, may be
				  the cause;
7. Documentation showing why the resident's age,
				  weight, or other factors would require a unique drug dose or drug duration,
				  indication, monitoring; and
8. Other evidence which may be appropriate.