DDS MEDICAL ADVISORY # 91-1

NEUROLEPTIC DOSE REDUCTION PROTOCOL
June 1999

Purpose:

The purpose of this advisory is to assure appropriate and safe neuroleptic dose reduction planning in order to promote optimal health of individuals who are on a neuroleptic regimen.

Applicability:

This advisory applies to all individuals who receives supports and services from the Department of Developmental Services regardless of the facility or region in which they are served.

The department recognized the special need to work with facilities, which it does not fund or license to ensure the thorough understanding and implementation of departmental policies and regulations.

Definitions:

Individual: 

An individual of the department regardless of the facility or region in which he or she is served.

Interdisciplinary Team (IDT): 

A group of people that includes the individual being served, his or her family, guardian or advocate, prescribing physician and consulting psychiatrist, those people who work most directly with the individual in each of the professions, disciplines or service areas that provide service to the individual, including direct care staff, and any other people whose participation is relevant to identifying the needs of the individual, devising ways to meet them, writing an overall plan of services and reviewing the plan for effectiveness.

Neuroleptic/Antipsychotic: 

Antipsychotic agents, also referred to as "neuroleptics", are used to treat psychotic symptoms such as hallucinations, delusions, thought disorders, bizarre behavior, and other conditions of equal severity. Usually when antipsychotic medications are prescribed for extended periods of time, i.e., greater than six months, the individual has a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, organic brain disorder, organic brain syndrome with psychotic features, affective disorder with psychotic features, and other conditions of equal severity. Commonly prescribed antipsychotic agents include (trade names) Thorazine, Mellaril, Haldol, Prolixin, Navane, Trilafon, Stelazine, Moban, Loxitane and Clozaril.

Risk/Benefit Ratio: 

Weighing the benefits of continued use of a medication, as measure by improved thought processes, behaviors, feelings, mental activity or mood with the potential risks inherent in the medication; some of which are: decreased mental alertness, decreased occupational or living skills, and the potential with extended us for the development of abnormal involuntary movements or other physical impairments.

Taper: 

to gradually diminish the dosage of medication in amounts and frequencies determined by the individual's changing mental, psychological, and physical reactions to current as well as previous reductions.

Neuroleptic Withdrawal: 

Neuroleptic withdrawal can result in several syndromes:

  1. physiological withdrawal symptoms such as nausea, sweating, increased heart rate, jitteriness.
  2. motor disorders such as dyskinesias (withdrawal TD) or become exacerbated (withdrawal exacerbated TD)

In people with developmental disabilities, it is easy to mistake physiological withdrawal for psychosis. There is no easy or definite way to make the distinction and a physician's advice should be sought if there is any uncertainty.

Reduced Dose Regimen: 

The lowered dose the individual had maintained for the most recent period of the plan, i.e., not the original dose. For example, the original dose was 100 mg QD, the lowered dose was 90 mg QD.

Psychotic Relapse: 

Psychosis, which is a result of neuroleptic withdrawal and may occur from hours to months following neuroleptic reduction or withdrawal. Psychotic signs or symptoms may include hallucinations, delusions, thought disorder or bizarre behavior.

Guidelines:

  1. Identifying Individuals for Dose Reduction
  1. DDS suggests the following protocol to help identify individuals for dose reduction if the physician and consulting psychiatrist have not identified a cause contraindicating a reduction plan in individuals having:
  1. no attempt at dose reduction in two years or more;
  2. a diagnosis not consistent with neuroleptic prescription (e.g. schizophrenia, organic brain syndrome with psychotic features, bipolar disorder, major depression with psychotic features, etc.);
  3. the presence of side effect such as tardive dyskinesia, extrapyramidal symptoms, or Parkinsonism; or
  4. inadequate demonstration of the benefit of antipsychotic medication over the last two years.

These guidelines would not apply to cases in which the physician and consulting psychiatrist have clearly documented within the past two years a reason to avoid dose reduction. Such documentation should extend beyond a written opinion, i.e., it should state the basis and reason(s) for that opinion in clear descriptive terms.

  1. Information needed for determining appropriateness of dose reduction by determining the risk/benefit ratio include:
  1. a comprehensive medical history;
  2. a behavioral history with both behavioral data and medication dose data documented;
  3. documentation and quantification of data illustrating the efficacy of the medication in reducing or eliminating target behaviors; and
  4. documentation of a relationship between dose reduction or medication discontinuation and emergence or increase in target behaviors.
  1. Preparing for Neuroleptic Dose Reduction

For dose reduction to succeed everyone must understand what is happening. The interdisciplinary team (IDT0 including staff, the individual and his or her family or guardian, and the physician understand all aspects and implications of a dose reduction.

  1. Preparation of staff
  1. Staff discussion should focus on:
  1. the risks of continuing the dose of neuroleptics, e.g., tardive dyskinesia (TD) and other unwanted side effects;
  2. fears of the consequences of dose reduction in the particular individual such as aggressive or self-injurious behaviors;
  3. identification of resources necessary to support the medication reduction plan;
  1. The IDT should participate in the development of behavioral plans, which address any initial medical or behavioral responses anticipated as a result of reduction. Such plans should be developed by persons with expertise in behavioral management, including physicians where appropriate and possible.

Neuroleptic dose reductions should not proceed until fears are resolved or contingency plans are in place. Technical assistance from persons with expertise in behavioral management may be essential.

  1. Preparation of the individual, family, guardian or advocate

The individual should be involved in all discussions and planning regarding the potential drug reduction when possible. This discussion should be tailored to the extent of his or her ability to understand. Such planning may include:

  1. Discussion of:
  1. risks of continued usage
  2. possible reactions to dose reduction
  3. identification and discussion of the individual's fears about possible reactions to dose reductions
  4. discussion of dose change
  5. date taper regimen to begin.
  1. Training of all involved individuals should include:
  1. changes in the appearance of the medication dosage
  2. change in the medication schedule
  3. examples of successful reduction plans for other individuals
  1. If the person expresses extreme anxiety or apprehension toward the medication reduction plan, we suggest an actual administration of the proposed reduced dose on day a week for several weeks or months prior to the actual dose reduction. This process may help to alleviate the individual's fears surrounding dose reduction.
  1. Neuroleptic Taper Protocol
  1. Documentation

    "Baseline" identification of target behaviors should be established which includes the frequency and duration of those specific behaviors over a four week period prior to neuroleptic taper. IDTs may wish to access appropriate professionals for methods of tracking and analyzing behavioral data.

  2. Reduction

    Reduce the dose by no more than 10 to 25 percent of the current regimen. Individual dose reduction schedules should be based on criteria such as age, duration of exposure to neuroleptics, severity of target behaviors, outcomes from previous reduction trials, and the presence of TD.

  3. Evaluation

    If the reduction is successful over a three to six month period, consider another reduction of 10 to 25 percent of the reduced dose regimen.

  4. Early Warning Signs of Psychotic Relapse

Early warning signs are behaviors or symptoms that occur prior to a severe psychotic relapse. If such behaviors can be recognized and the medication dose increased, a severe exacerbation can be avoided. These signs are listed in Appendix A, with a suggested checklist for documentation in Appendix B.

Sometimes, following a dose reduction, behavioral changes may occur that do not actually constitute early warning signs of relapse. We have no good way to distinguish such behaviors, so careful assessment and judgment by a knowledgeable physician is essential. As a guideline, the persistence of behavioral changes following a dose reduction for three or more days should be considered an indication of early warning signs. This is only a guideline and may be waived if the judgment of the team or physician determine a shorter or longer trial to be more appropriate.

  1. If early warning signs of relapse occur for three consecutive days, neuroleptic dose may need to be increased. It is crucial that behavioral strategies have been implemented and that the frequency and intensity of target behaviors be documented.
  2. If early warning signs disappear after three to five weeks' treatment with increased dose, revise the behavioral plan as necessary, implement contingency plans if appropriate, return to the reduced dose, and continue to observe.
  3. If early warning signs occur for more than five weeks with increased dose, do not consider dose reduction again for at least six months.
  4. If situation "3" above should recur, the IDT should refer to the selection criteria above to determine the appropriateness of further reduction attempts.
  1. Neuroleptic Withdrawal syndromes to watch for during taper and suggested responses:
  1. Physiological reactions that may occur within days or weeks following a dose reduction may include the following:
  1. body changes including jitteriness, sweating, agitation, palpitations, flushing, nausea, and weight loss;
  2. movement disorders including TD and/or restlessness (akathesia).
  1. The suggested response to neuroleptic withdrawal is as follows:
  1. unless excessively severe, document signs for three or more days prior to increasing dose;
  2. reinstitute the dose that the individual was receiving just prior to the most recent reduction;
  3. attempt a smaller dose reduction when the individual is stabilized at the dose that he or she was receiving just prior to the most recent reduction.

NOTE: The emergence of physiological withdrawal signs is not a reason to maintain the individual on antipsychotic medication. Rather, it means that the percentage of dose reduction needs to be smaller for that individual. In these cases, it is not necessary to wait for three to six months before re-attempting a dose reduction.

NOTE: When early warning signs of psychotic relapse cannot be distinguished from physiological neuroleptic withdrawal reaction, the safest and most appropriate course of action may be to return to the original dose of neuroleptic. Careful documentation of behaviors may be helpful in distinguishing between these two responses. The prescribing physician can/or the consulting psychiatrist will carefully evaluate the individual's status, including the collected data to distinguish between these two responses. The ultimate decision to return to the original dose must be carefully made based on the physician's and psychiatrist's reviews.

  1. Implications or an Overly Aggressive Dose Reduction Schedule:

When neuroleptic medications are reduced and/or discontinued in an overly aggressive manner both physiological and psychological reactions may occur. The time required for physiological equilibrium to be reached after a dose change may be several months. Thus frequent dose reductions may result in physiological withdrawal symptoms. These in turn may cause psychological decompensation or relapse.

  1. Probable causes

    1. reductions in excess of 10 percent to 25 percent
    2. reductions more frequently than every three to six months

  2. Common effects
  1. physiological withdrawal syndromes
  2. relapse because dosage falls below minimum optimal maintenance dose
  3. fear of change on behalf of individual, staff or relative

The neuroleptic dose reduction protocol detailed in this advisory may be utilized by interdisciplinary teams as a framework for evaluating and planning safe and appropriate neuroleptic reduction plans.

 Prepared for DMR by: William M. Glazer, M.D.


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