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PURPOSE Psychotropic medications are an essential treatment in the management of mental illness and also can be an important support in the management of behavior. Effective use of psychotropic medication requires complex monitoring procedures. The purpose of this policy is to set clear expectations and provide guidelines for the completion of psychotropic medication monitoring requirements. POLICY Recognition of both the benefits of psychotropic medications and the possible risks inherent in the administration of these medications requires specific evaluative procedures to be followed to ensure appropriate and effective use of psychotropic medications. These procedures are specified in the Psychotropic Medication Monitoring Checklist regulations (PMUC). The PMUC is a best practice guide for effective psychotropic medication monitoring. The Psychotropic Medication Use Checklist specifies procedures which must be followed in the event responsibility for psychotropic medication monitoring is assigned to the license holder. Responsibilities for psychotropic medication monitoring vary with the licensure of the service location. Each licensed service location will have specific procedures detailing their responsibilities in the completion of psychotropic medication monitoring requirements. The responsibility for compliance to the Psychotropic Medication Use Checklist will be assumed by the residential license holder when the person served lives in a licensed site. When the person served does not live in a licensed site, the case manager may choose to assign responsibility for psychotropic medication monitoring. Psychotropic medication monitoring procedures will be followed for all psychotropic medications. Psychotropic medications include medications prescribed for the purpose of altering an individual’s behavior and medications prescribed for the treatment of psychiatric symptoms. In general, psychotropic medications are prescribed to stabilize or improve mood, mental status, or behavior. Psychotropic medication monitoring procedures are not required:  When psychotropic medications are prescribed for reasons other than behavior alteration. (i.e. Ativan prescribed for treatment of seizures, Valium prescribed for cerebral palsy, or a nicotine patch or Zyban used for the treatment of smoking cessation).  When psychotropic medications are prescribed prior to medical/dental examinations or treatments.  For metrochlopromide (Reglan), a Tardive Dyskinesia (TD) assessment is required. However, because it is not a psychotropic medication, no other psychotropic monitoring procedures are indicated.  For medications prescribed and administered by health professionals outside the site. (i.e. medications administered during hospitalizations, medications administered in the physician’s office or emergency room).  For acetylcholinesterase inhibitors used for the treatment of dementia. Acetylcholinesterase inhibitors are prescribed to slow the progression of memory deterioration in Alzheimer’s disease and other dementias. Continued use or dose adjustment of these medications is not based on behavioral data. Therefore, psychotropic medication monitoring procedures are not appropriate. However, psychotropic medication monitoring is expected for medications that are prescribed for management of specific behaviors that may occur with dementia. Psychotropic medications will not be used:  For disciplinary purposes.  For convenience of staff.  As a substitute for a behavior/therapeutic program.  In quantities that interfere with daily living activities. OP-P0032
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PROCEDURE A. A Behavior Support Plan will be completed prior to initiation of non-emergency administration of psychotropic medications by the interdisciplinary team (IDT) and will include the following: 1. Identify the behavior or psychiatric symptom presenting the problem. 2. Describe the specific behavior/psychiatric symptom in observable and measurable terms (target 3. Complete a functional assessment on the behavior or psychiatric symptom to determine: a. If a medical evaluation is indicated to rule out a medical cause for the behavior or b. If a psychiatric referral is indicated. 4. Determine a data collection method, and if appropriate, desired alternative behavior, for each target 5. Collect a minimum of two weeks of baseline data on the behavior or psychiatric symptoms. If unable to obtain two weeks of baseline data, staff will document the reasons. 6. Identify environmental situations which may affect data. 7. Document interdisciplinary team involvement in the discussion of: a. Target behaviors b. The need for psychotropic medication c. Data collection methods d. Plans to initiate or continue medication 8. The IDT discussion must be completed and documented in the IDT meeting notes within 30 days of the annual meeting. A copy must be provided to the case manager for inclusion in the Individual Service Plan (ISP). 9. Develop a Behavior Support Plan. a. Determine the frequency of data reviews and document this on the BSP. b. Identify staff training required for data collection, recording of behavioral outcomes, and 10. Annually, the IDT will discuss/review: a. The Behavior Support Plan b. The therapeutic effects from the psychotropic medication c. Medication plans, including whether the psychotropic medication is at the lowest therapeutic dose B. Data collection provides objective behavioral information for the health care prescriber and other members of the interdisciplinary team. 1. An objective data collection method must be used to measure a target behavior or psychiatric symptoms in order to evaluate medication effectiveness. 2. Data collection will occur for the duration of time the psychotropic medication is administered. 3. One or more of the following data collection methods will be used: a. Frequency count b. Duration recording c. Time sampling d. Interval recording e. Permanent product f. Rating scales 4. The data collection method will be identified in the Behavior Support Plan (BSP). 5. A minimum of two weeks of baseline data will be obtained prior to non-emergency initiation of the 6. Identify environmental situations that may be reflected in the data. 7. All staff will be trained on the data collection method and recording of behavioral outcomes. C. To meet prescribing guidelines for psychotropic medication, written justification by the health care prescriber must occur for the following: 1. Intraclass polypharmacy (two medications from the same therapeutic class are prescribed). 2. Interclass polypharmacy (more than two medications from different therapeutic classes are prescribed). OP-P0032
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3. Medication dosages that exceed the FDA maximum. D. Written informed consent for each prescribed psychotropic medication will be obtained. a. Prior to non-emergency initiation. b. Within 30 days of emergency initiation, if the psychotropic medication continues to be prescribed. c. At least annually while psychotropic medication is prescribed (annually is defined as prior to or within the same month of the subsequent calendar year). 2. The written informed consent includes the date and signature of the person served, if competent, or the 3. The written informed consent provides information specific to the individual medication(s) and must include at a minimum: a. Generic and commonly known brand name of the medication(s) b. The purpose(s) of the medication(s) c. The risks and possible side effects (including TD), and their treatment d. The expected benefits of the medication(s) e. The feasible alternatives if a psychotropic medication is not prescribed f. The route of administration g. The estimated duration of psychotropic medication use h. An explanation that consent may be withdrawn at any time i. An explanation that the consent is time limited j. The name, address, and phone number of appropriate personnel to contact should questions or 4. The above information will be provided to the person served and/or legal representative. This information will be provided both orally and in writing. Any exceptions to this must be justified and documented. a. The psychotropic medication is not initiated b. The psychotropic medication is discontinued by the health care prescriber c. A court order is obtained within 45 days to override the refusal 6. The PMUC allows for oral informed consent to be obtained prior to the initiation of psychotropic medication. Generally, oral informed consent is not recommended; however, there may be circumstances where this is indicated. 7. When the health care prescriber determines that a new psychotropic medication must start immediately and written consent cannot be obtained prior to the initiation of the medication, the following must occur: a. Oral information must be given b. Oral consent must be verified by a witness c. The circumstances must be documented and d. Written consent must be obtained within 45 days 8. When written consent is not obtained within 45 days: a. The health care prescriber must be notified to determine if the medication will be discontinued b. A court order must be obtained if a decision is made to continue the medication E. Pro Re Nata (PRN) psychotropic medications are administered on an “as needed” basis. 1. All PRN use of psychotropic medications must have the following: a. Written behavioral criteria b. Written procedural criteria c. The criteria must be approved by the Interdisciplinary Team (IDT) 2. Monitoring for side effects for PRN medication use will occur at the time of administration and will be documented in the person’s record or on the Psychotropic PRN Use form. 3. The following must be documented when a PRN psychotropic medication is used: OP-P0032
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4. PRN psychotropic medications must be reviewed for effectiveness at a frequency determined by IDT and the frequency must be documented in the Behavior Support Plan. 5. The minimum frequency of review is annually for the use of PRN psychotropic medication. However, it is recommended that this review of PRN psychotropic medication use occur more frequently. The IDT may consider which of the following review frequencies is most appropriate to the situation: a. At each use b. On a monthly basis c. On a quarterly basis d. On an annual basis F. Psychotropic medication emergency initiation requirements apply only to those unplanned situations where emergency psychotropic medication is administered by residential staff. 1. Emergency initiation of psychotropic medications will not occur unless an imminent and substantial risk of physical danger to the person served or others is identified and documented. 2. Behavior outcomes resulting from emergency initiation will be documented. 3. The legal representative and case manager will be informed about the emergency use within 72 hours. 4. Written informed consent will be obtained within 30 days if continued use of the psychotropic G. All psychotropic medications will be monitored for the presence of side effects. 1. Laboratory assessments ordered by the health care prescriber will be completed as prescribed. 2. Completion of laboratory assessments will be documented in the individual’s record. 3. Laboratory findings will be maintained by the health care prescriber. 4. On-site information about medication side effects will be available to all staff. 5. At the time of consent, the person served or the legal representative must be informed both orally and in writing about the possible side effects of the medication. 6. Neuroleptic Malignant Syndrome (NMS) is a possible side effect of antipsychotic medication and amoxapine. If these medications are prescribed, specific information on NMS should be provided at the time of consent. 7. Side effects assessments will be completed and documented in the person’s record using one of the following standardized assessment instruments: a. MOSES (recommended) b. SAFTEE c. DOTES d. Or a checklist from a standard pharmaceutical or medical reference. 8. To promote accurate comparison to baseline, one assessment instrument should be consistently used for 9. Side effects assessments will be completed: a. Prior to the non-emergency initiation of psychotropic medications (baseline status) b. Within 30 days after initiation of a new psychotropic medication c. Within 30 days after a dose increase of a psychotropic medication d. Approximately every 6 months (no greater than every 7 months) while a person served is taking 10. In the emergency initiation of a psychotropic medication during a psychiatric crisis it is impossible to do a side effect baseline assessment. Therefore, it is unlikely that a baseline side effect status will be completed for emergency initiation of a psychotropic medication. 11. Adverse reactions to psychotropic medication will be reported to the health care prescriber 12. A licensed health care provider will be notified within five working days of changes from baseline status or the most recent side effects assessment. This further notification is not required when a nurse completes the MOSES. 13. When side effects occur, one of the following situations must be documented: OP-P0032
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a. The side effects do not impair functional status or quality of life. b. The side effects impair functional status or quality of life and the medication is decreased or c. The side effects impair functional status or quality of life and the medication is not decreased or discontinued. In this situation, information must also be documented on how was the decision reached, who was involved in the decision making process, and how this was communicated with the health care prescriber. H. A Tardive Dyskinesia (TD) assessment is required when a person served is prescribed an antipsychotic (neuroleptic) medication. 1. Other medications requiring a TD assessment are: a. Amoxapine (Asendin®) b. Olanzapine/fluoxetine (Symbyax) c. Metrochlopramide (Reglan®) (Use of metrochlopramide requires a TD assessment; however, no other psychotropic medication monitoring procedures are indicated). 2. At the time of consent, the person served or legal representative must be informed both orally and in writing about the possible side effect of Tardive Dyskinesia. 3. TD assessments will be completed and documented in the person’s record using one of the following standardized assessment instruments: a. DISCUS (recommended) b. AIMS c. TDRS d. TRMS 4. To promote accurate comparison to a baseline, one assessment instrument should be consistently used for a person served. Training in the use of the assessment instrument is necessary to accurately screen for TD. a. Every six months (six months is defined as anytime within the calendar month that the TD b. At one, two, and three calendar month intervals after all Tardive Dyskinesia-causing drugs have c. Annually if persistent TD has been diagnosed and the individual does not receive Tardive I. Data reviews will be completed for the monitoring of psychotropic medication. 1. The purpose of the data review is to: a. Bring together relevant information about behavioral data and identified side effects to assist in decision making about continued psychotropic medication use b. Evaluate medication and dose effectiveness c. Determine if the current behavioral data supports the desired outcome d. Determine if an imminent medication evaluation is indicated. 2. Data reviews must occur, at a minimum, on an annual basis. In many instances, a more frequent review 3. The IDT determines the frequency of data reviews and may use the following guidelines in the decision making process: a. Monthly; when there is frequent medication or dose changes b. Quarterly; when medication and doses are stabilized c. Every six months or annually; when there is long-term psychotropic use, with stable behaviors and 4. The frequency of data reviews, as determined by the IDT, will be documented in the BSP. 5. At each data review, the following information will be reviewed and documented: OP-P0032
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b. The comparison of current data to baseline/previous data to determine evidence of therapeutic c. The current Behavior Support Plan d. Environmental factors that may affect data e. The current psychotropic medication, dose, and route of administration J. Specific procedures will be developed for each licensed service location, detailing responsibilities in the completion of psychotropic medication monitoring requirements. K. Good communication with the health care prescriber is required to ensure appropriate and effective use of psychotropic medications. The Referral for Psychotropic Medication Evaluation form may be used to facilitate this communication L. While not required under the PMUC, a medication history is a valuable resource for continuity of care. The Medication/Treatment Summary form can be used to document a history of all medications prescribed. M. Additional information regarding psychotropic medication monitoring is available from the Department of Human Services (DHS) website ator the DHS licensor assigned to the program. ADDITIONAL PROCEDURES In addition to the previously described procedures, when applicable, the following additional procedures will be taken for Intermediate Care Facilities for Persons with Developmental Disabilities (ICF/DD): A. Psychotropic medications will be used only as an integral part of an individual program plan that is approved by the interdisciplinary team (IDT). B. The IDT has discussed the risks and benefits of the psychotropic medications to address the target behaviors/symptoms and has approved the use of the medication as being consistent with the active treatment program. C. The facility must have a specially constituted committee to review, approve, and monitor the use of psychotropic medications. This committee is usually known as the Human Rights Committee. The nurse and program director will communicate to ensure that the Human Rights Committee’s policies are followed prior to and throughout the course of psychotropic medication therapy. This would include committee approval prior to the initiation of a psychotropic medication. D. When psychotropic medication is prescribed prior to medical/dental examinations or treatments, specific psychotropic medication procedures as identified in the PMUC are not required. However, federal guidelines for ICF/DD do require: 1. Legal representative’s consent 2. Review and approval by the Human Rights Committee 3. Incorporating an active treatment program that includes a behavior component that will reduce or prevent the need for pre-appointment sedation E. The PMUC does not have specific requirements for minimal effective dose (MED). Federal guidelines for ICF/DD require that: 1. A gradual withdrawal of psychotropic medications occur annually or sooner if warranted and as 2. Decisions to reduce or eliminate a medication are based on the person’s diagnosis, treatment response, 3. At least annually, the IDT must evaluate whether psychotropic medications are at the lowest therapeutic 4. There is documentation, including justifications, that supports the decisions made regarding minimal OP-P0032
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