MHEI transcript 3 screening for suicide risk

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The Mental Health Educational Initiative is an interactive program that utilizes a combination of formal and non-formal learning to provide a multidisciplinary group of health care providers with a unique model for the understanding, identification, and management of actual vs. perceived risk for suicidal ideation and related adverse events.

This is the third in a series of 4 podcasts & transcripts presented by David Neubauer, M.D.
Associate Professor
Psychiatry and Behavioral Sciences
Johns Hopkins Bayview Medical Center

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MHEI transcript 3 screening for suicide risk

  1. 1. PODCAST TRANSCRIPT 3: SCREENING FOR SUICIDE RISKNeubauer, David N., M.D.Associate ProfessorPsychiatry and Behavioral SciencesJohns Hopkins Bayview Medical CenterHello, this is David Neubauer and I would like to welcome you back to this podcast seriesfocusing on the issues surrounding the suicide risk associated with the use ofmedications, particularly antidepressant and antiepileptic agents, and particularlyamong children, adolescents, and young adults. This is the 3rd of four podcasts. The firstinstallment examined the history of the concern about medications possibly increasingsuicidality – meaning suicidal ideation, as well as suicide attempts and completedsuicides – especially following the 2004 FDA Black Box warning for antidepressantsprescribed for children and adolescents and the subsequent extension to young adultsand to the warnings about antiepileptic agents. The first podcast dealt primarily withantidepressants and the second with antiepileptics.There has been considerable discussion about the suicidality risk warnings due to theconcern that they could lead to the under treatment of patients resulting in overallworse outcomes than the slight increase in suicidality risk, especially given the fact thatthere were no actual suicides in the clinical trials that stimulated the warnings in thefirst place. But most commentators agree that the suicidality signal in the data from theclinical trials warrants the education and monitoring suggested in the FDA warnings.Now, in this third podcast, we’ll focus on a recent update on this subject from the FDA.In August, 2012 the FDA issued a document entitled, “Guidance for Industry: SuicidalIdeation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.” Register here to earn credit for this activity: http://my.mediklu.com/pg/reg/mhei Presented by The Johns Hopkins University School of Medicine Developed through a strategic educational facilitation by Medikly, LLC. Supported by an educational grant from Lilly USA, LLC.
  2. 2. This document is described as a draft guidance representing the FDA’s current thinkingon the topic and at this point contains nonbinding recommendations. As the titlesuggests, the focus is identifying suicidal ideation and behaviors in subjects participatingin clinical trials, which in recent years has been required for these studies with selectedmedications. The document cites two key reasons for requiring the assessments: 1) identifying clinical trial participants who might develop treatment-emergent suicidalideation and behavior so that they can receive appropriate evaluation and treatment,2) so that data regarding potential suicidal ideation and behavior can be collected andorganized in a manner that will allow further assessment of the risks associated withparticular medications.The FDA reiterated the importance of systematically and prospectively collecting dataon the presence or absence of suicidal thoughts or actions in clinical trials, rather thanrelying on the process in past years when these were noted only when spontaneouslyreported.While this recent FDA Guidance document deals entirely with clinical trials, in manyways the discussion is relevant to monitoring in clinical practice settings where ongoingassessment for suicidality previously was recommended.Here are some of the highlights of this 2012 document, which may continue to berevised over time.One of the most obvious changes is in the realm of language. They have dropped thatproblematic word, suicidality, in favor of the more precise phrase, “suicidal ideation andbehavior.” This is welcome, since “suicidality” always needed further explanation.The 2012 Guidance also clarified the categorization that the FDA required for theongoing assessment of suicidal ideation and behavior. This classification system includes11 options made up of 5 suicidal ideation descriptions, 5 suicidal behavior possibilities,and a single category of self-injurious behavior with no suicidal intent. This is theclassification system that also has been adopted by the Center for Disease Control andPrevention. Register here to earn credit for this activity: http://my.mediklu.com/pg/reg/mhei Presented by The Johns Hopkins University School of Medicine Developed through a strategic educational facilitation by Medikly, LLC. Supported by an educational grant from Lilly USA, LLC.
  3. 3. The 5 suicidal ideation options are: 1. Passive suicidal ideation – or a wish to be dead or go to sleep and not wake up 2. Active suicidal ideation: Nonspecific - that is, with no method, intent or plan 3. Active suicidal ideation: Method, but no intent or plan. Those in this category have contemplated how they might end their lives, but have no specific plan and may even feel that they would never do it. 4. Active suicidal ideation: Method and intent, but no plan. Here the individual admits to actually considering the act, but there is no specific plan to do it. 5. Active suicidal ideation: (You guessed it) Method, intent, AND plan.The 5 suicidal behavior options are: 1. Completed suicide – self-injurious act with at least some intention to die leading to the person’s death. 2. Suicide attempt – Here there has been a potentially self-injurious act with some intent to die, although the act does not necessarily lead to injury. 3. Interrupted suicide – People classed here would have attempted suicide had they not been interrupted by outside circumstances. 4. Aborted suicide – Here people, on their own, stop after initiating steps toward engaging in self-injurious behaviors. 5. Preparatory acts toward imminent suicidal behaviors – With this category, people do not initiate a suicide attempt, but do demonstrate actions consistent with preparing for suicidal behavior, such as acquiring pills or a gun, or perhaps giving away possessions or writing a suicide note.The 11th category, self-injurious behavior without suicidal intent, is important indistinguishing these actions where there is injury but no intent or desire to die.In the recent Guidance on Suicidal Ideation and Behavior, the FDA stated that theseexact categories should be employed in clinical trials where the assessments arerequired. These are the basic definitions and exact categories in the Columbia – SuicideSeverity Rating Scale (C-SSRS), which evolved from the Columbia – ClassificationAlgorithm of Suicide Assessment (C-CASA) that we reviewed in the our first podcast. TheFDA does not require that investigators use the C-SSRS instrument, but the assessmentsmust use the same classification system. Register here to earn credit for this activity: http://my.mediklu.com/pg/reg/mhei Presented by The Johns Hopkins University School of Medicine Developed through a strategic educational facilitation by Medikly, LLC. Supported by an educational grant from Lilly USA, LLC.
  4. 4. We’ll come back around to the C-SSRS in the final podcast when we explore practicalstrategies for assessing suicide risk in clinical settings. I will note here that the C-SSRSdoes incorporate probing questions to assess subjects’ thoughts and actions, and thattraining in the use of the C-SSRS instrument is recommended.Another focus of the 2012 FDA Guidance document is the burden involved in doinginitial visit and follow up assessments of suicidal ideation and behavior. The conclusionis that it really isn’t a great burden at all. With no positive responses to the screeningquestions, the C-SSRS can be completed in just one to two minutes. Even when positiveresponses are present, the detailed interview almost always is completed in less thanten minutes. Although the C-SSRS is primarily an interview assessment, it does allowintegration of data from other sources, such as family and friends, care providers,medical records, and death certificates or medical examiner reports.The Guidance document also states that an electronic self-report version has beentested and would be considered an acceptable alternative – further decreasing theburden in the screening process, and perhaps allowing the subjects greater comfort indescribing their thoughts and actions. Of course, the responses would have to bereviewed by the investigators and appropriate steps taken when indicated.One interesting element of the 2012 FDA Guidance supporting the C-SSRS relates to theimportance of any lifetime history of suicidal thoughts or behaviors in relation topredicting future suicide risk. At least in clinical trials, the baseline C-SSRS rates thelifetime occurrence of any suicidal thoughts or behaviors. Recent research hasdemonstrated that this lifetime history is an especially powerful predictor of futuresuicide thought and behavior risk.Until now the FDA primarily has targeted antidepressants and antiepileptic agents forthe warnings and for strict requirements for assessments during clinical trials. Therecent FDA Guidance suggested that several other types of medications also may haveelevated risks for suicidal thoughts and behaviors, and therefore perhaps also shouldincorporate the same assessments during clinical trials and perhaps may need warnings Register here to earn credit for this activity: http://my.mediklu.com/pg/reg/mhei Presented by The Johns Hopkins University School of Medicine Developed through a strategic educational facilitation by Medikly, LLC. Supported by an educational grant from Lilly USA, LLC.
  5. 5. for prescribers and patients. The Guidance notes that concerns for increased suicidalthoughts and behaviors have been reported with reserpine, certain beta blockers,smoking cessation drugs, some weight loss drugs, as well as isotretinoin and othertretinoins.This recent FDA Guidance for Industry regarding treatment emergent suicidal thoughtsand behaviors just deals with the development and administration of clinical trials. So,how does it relate to clinical practice and the warnings of potential increased suicide riskwith selected medications, and the recommendation for education and ongoing patientassessment? The answer is that the highly systemized and controlled and welldocumented assessments in the clinical trials provide testable models so that efficientand reliable methods can be used in clinical settings. We are being provided withconstructs for suicidal thought and behavior categories and evidence-based scales andassessment instruments that readily can be applied in private offices, clinics, and evenonline.So, stay tuned for the 4th and final podcast in this series when we will consider practicalaspects of suicide risk screening in patients taking medications having the potential fortreatment-emergent increases in suicidal thoughts and behavior.Thank you for joining us today. Register here to earn credit for this activity: http://my.mediklu.com/pg/reg/mhei Presented by The Johns Hopkins University School of Medicine Developed through a strategic educational facilitation by Medikly, LLC. Supported by an educational grant from Lilly USA, LLC.

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