Psychotropic Medication Advocacy

1. Psychotropic Medication Advocacy

2. Result of concerns about the use of psychotropic medications for people with MR/DD. 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 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.

3. 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

4. #1-Psychotropic Medication Definition A psychotropic medication is any drug prescribed to stabilize or improve mood, mental status, or behavior.

5. #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.

6. #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

7. #1-Psychotropic Medication Definition This includes herbal or nutritional substances when such substances are used to stabilize or improve mood, mental status, or behavior.

8. #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.

9. #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.

10. #2-Inappropriate Use Excessive includes: inappropriately high doses or inappropriately long periods of time relative to the diagnosis or condition of concern.

11. #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).

12. #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.

13. #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.

14. #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.

15. #3-Multidisciplinary Care Plan Psychotropic medication must be used within a coordinated multidisciplinary care plan designed to improve the individual’s quality of life.

16. #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

17. #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.

18. #3-Multidisciplinary Care Plan This does not include stat orders that by definition constitute emergency intervention. This guideline applies to PRN orders.

19. #4-Diagnostic and Functional Assessment The use of psychotropic medication must be based on: 1) a psychiatric diagnosis, or • a specific hypothesis if a psychiatric diagnosis is unclear at the time resulting from a diagnostic and functional assessment.

20. #4-Diagnostic and Functional Assessment • A diagnostic & functional assessment address: • Organic and medical pathology • Psychosocial & environmental conditions • Health status • Current medications • Presence of a psychiatric condition • History, previous interventions/results • Functional analysis of behavior

21. #4-Diagnostic and Functional Assessment • Functional analysis of behavior addresses: • what, if any, antecedents or consequences affect/control a behavior, • whether behavior represents a deficit or excess, or is situationally inappropriate, • whether different patterns occur in different situations, • possible schedule of reinforcement effects.

22. Functional Assessment Functional Assessment examples: Systematic Manipulation of Variables: Functional Analysis of Behavior Interviews: Functional Assessment Interview Contextual Assessment Inventory

23. #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.

24. #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.

25. #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.

26. #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.

27. #5-Informed Consent Information provided to the person/guardian includes: 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.

28. #6-Index Behaviors and Empirical Measurement Index behaviors & quality of life outcomes must be: • objectively defined • and tracked using an empirical measurement method(s) in order to evaluate and monitor psychotropic medication efficacy.

29. #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).

30. #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.

31. #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.

32. #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.

33. #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.

34. #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.

35. #7-Side Effects Monitoring • Standardized assessment instruments mean: • A published or recognized scale • A checklist constructed from standard pharmaceutical or medical references. A 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.

36. #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.

37. #8-Tardive Dyskinesia Monitoring Tardivedyskinesia (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.

38. #8-Tardive Dyskinesia Monitoring 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.

39. #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.

40. #9-Regular and Systematic Review Psychotropic Medication must be reviewed on a regular and systematic basis.

41. #9-Regular and Systematic Review • Systematic review means a coordinated procedure between all parties to: • share, review, document, and act on information such as index behavior, quality of life, and side effects data and • communicate drug, dose, and • non-pharmacological changes. Regular means at least once every 3 months and within 1 month of drug or dose changes. The review schedule should be outlined in the care plan.

42. #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.

43. #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.

44. #10-Lowest Optimal Effective Dose If several psychotropic medications are prescribed, it may be possible to reduce the number of drugs, although a medication-free status is not possible. Lowest optimal effective dose (OED) means the least amount of medication required to improve or stabilize the problem.

45. #10-Lowest Optimal Effective Dose 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. Periodic means every medication review with in-depth risk:benefit analysis provided at least once per year

46. #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.

47. #11-Frequent Changes Frequent drug and dose changes should be avoided.

48. #11-Frequent Changes 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. Medications can take varying times to work, e.g. antidepressant drugs may take 2-8 weeks before the full effect is seen.

49. #13-Practices to Minimize Long-term use of PRN orders. Long-term is more than a few weeks. Regular use of a PRN beyond a few weeks indicates a need to consider an environmental cause or to review the treatment plan. 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.

50. #13-Practices to Minimize Long-term use of benzodiazepine anti anxiety medications, such as diazepam (Valium). Long-term use of these may lead to diminishing effectiveness, tolerance, and pronounced withdrawal reactions. Long-term is more than 3 months.