PTSD Policy and Pharmacology Update. Disclosures/Conflicts

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1 PTSD Policy and Pharmacology Update Maryland Pharmacists Association 134th Annual Convention Ocean City, MD June 12, 2016 Marsden McGuire, M.D., M.B.A. Deputy Chief Consultant, Mental Health Services Office of Patient Care Services Department of Veterans Affairs Washington, DC None Disclosures/Conflicts 1

2 Background: Political Structure Constitution Executive Branch (Legislative oversight) Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Office of Policy and Planning Office of Patient Care Services Mental Health Services Veteran Integrated Service Network (VISN) Facility Background: Process and Environment Politics VA Care continuum Government health care especially vulnerable socialized medicine election year politics Multiple feedback loops => may lead to policy changes (improvement?) 2

3 Policy: Definition A course or principle of action adopted or proposed by a government, party, business, or individual. Ideally informed by wisdom, experience and a sense of the greater good Example: VA Handbook (2008) A.k.a. Uniform Mental Health Services Handbook (UMHSH) conveys general principles, minimum requirements (including for PTSD) revision in concurrence Evidence Based CPGs Informs policy Aim to improve care by reducing variation in practice and systematizing best practices Cornerstones for accountability and facilitate learning and the conduct of research Represent the best current amalgam of research and expert opinion Trade off between sensitivity and specificity 3

4 All Guidelines are Not Created Equal VA/DoD CPG is 1 of 6 CPGs for PTSD Methodology of the 6 CPGs and the IOM report varied, however, there is a high level of consensus in recommendations for PTSD treatment among them VA/DoD guideline is unique in having primary care serve as point of entry For more information, see Forbes et al., 2010 review of the guidelines in Journal of Traumatic Stress 2010 VA/DoD Clinical Practice Guidelines for PTSD: Coding Quality of Evidence: Good, Fair, or Poor Net Benefit: Substantial, Moderate, Small, or None Quality of the Evidence + Net Benefit = Strength of the Recommendation (A, B, C, I or D) 8 4

5 Strength of Recommendations A B C I D A strong recommendation to provide Good evidence benefits substantially outweigh harm A recommendation to provide Fair evidence benefits outweigh harm No recommendation for or against. Fair evidence but balance of benefits and harms is too close to justify a general recommendation Evidence is insufficient to recommend for or against Balance of benefits and harms can not be determined Recommendation against Fair evidence that intervention is ineffective or that harms > benefits Psychotherapy for PTSD: Summary Balance = Benefit - Harm SR SUBSTANTIAL SOMEWHAT UNKNOWN A Trauma-focused psychotherapy that includes components of exposure and/or cognitive restructuring and Eye Movement Desensitization and Reprocessing; OR Stress inoculation training C Patient Education, Imagery Rehearsal Therapy, Psychodynamic Therapy, Hypnosis, Relaxation Techniques, Group Therapy I Family Therapy Web-Based CBT, Dialectical Behavior Therapy, Acceptance & Commitment Therapy 5

6 Strongly Recommended PTSD Psychotherapies (Level A) The strongest evidence supports trauma focused cognitivebehavioral therapy Cognitive Processing Therapy (CPT) is the most well researched cognitive therapy treatment package Prolonged Exposure (PE) is the most well researched exposure therapy treatment package CPT and PE work for patients with PTSD and comorbid problems such as TBI, depression, and substance abuse VA has trained over 6,000 therapists in PE or CPT Eye Movement Desensitization and Reprocessing (EMDR) Stress Inoculation Training 11 What is Cognitive Processing Therapy (CPT)? Psychotherapy that helps patients understand how the trauma changed the way they think Standard protocol is 12 weekly 60 minue sessions Components: Learning about PTSD symptoms Becoming aware of thoughts and feelings Learning skills to challenge unhelpful thoughts and feelings (cognitive restructuring) Changing unhelpful beliefs Can include a written account of traumatic event(s) 12 6

7 What is Prolonged Exposure (PE)? Psychotherapy that helps patients process a trauma through repeated exposure to avoided feelings, thoughts, and situations until distress decreases Helps patients learn that reminders of the trauma do not have to be avoided Standard protocol is 10 weekly 90 minute sessions Components: Education Breathing retraining for relaxation Engagement in avoided activities (in vivo exposure) Talking through the trauma (imaginal exposure) 13 Group Treatment (Level C) No recommendation for or against Group therapy is more effective than no treatment No evidence comparing group to individual therapy Emerging evidence (published after the VA Guideline) shows effectiveness of group Cognitive Processing Therapy 14 7

8 Family Considerations (Level I) Insufficient evidence to recommend for or against family or couples therapies as first line treatments for PTSD (Level I), but... Useful for managing PTSD related conflict, increasing support or improving communication Significant others should be advised to consider assistance to address problems related to patient s PTSD In 2010, the VA expanded services in order to provide mental health, marriage and family counseling, and other services to members of a Veteran s immediate family, the legal guardian of a Veteran, or other live in significant other 15 Pharmacotherapy Recommendations SSRI (Selective Serotonin Reuptake Inhibitor) Sertraline* Paroxetine Fluoxetine SNRI (Serotonin Norepinephrine Reuptake Inhibitor) Venlafaxine* Other Mirtazapine Nefazodone* (Caution: liver injury) Tricyclic Antidepressants (TCAs) Amitriptyline, imipramine *Outperformed others in new meta analysis Lee et al,

9 Useful Add on Therapies in PTSD Trauma nightmares Prazosin titrating to the right dose (Alexander 2016) SSRI partial responder Add Prolonged exposure therapy (Rothbaum 2006) Resistant Depression SSRI + Mirtazapine (Schneier 2015) Alcohol Use Disorder Topiramate (Batki 2014) Chronic Pain plus Substance Use Disorder Buprenorphine (Seal 2016) Benzodiazepines (BZDs) No Benefit in PTSD Evidence of harm has grown since VA/DoD PTSD CPG recommendation in 2010 Should particularly be avoided in PTSD subgroups: History of TBI or Substance Use Disorder 65 years and older Concurrent sedatives such as opioids Pulmonary disease and sleep apnea Women of child bearing age Clinicians should avoid new BZD starts, educate patients taking BZDs about risks (and discuss starting slow taper) 18 9

10 Academic Detailing The sharp point of the CPG spear Best tool we have for managing variation through education (especially in combination with practice measurement) Caveats Guidelines may be wrong, incomplete or outdated Less variation is not always better Threat to providers sense of autonomy, and willingness to care for challenging patients Measurement Based Care: Making Informed Choices SSRI, SNRI Assess Adherence, Side Effects, and Increase dose as necessary Switch to another SSRI or SNRI Switch to or add mirtazapine Switch to nefazodone or TCA Refer to Psychotherapy Refer to Specialty Care Add Prazosin for nightmares 10

11 PTSD Consultation Program Originally launched in 2011 to support VA providers and now available to providers outside of the VA who are treating Veterans with PTSD. Services are free. Callers can speak directly with experts from the National Center for PTSD about: Evidence based treatment Clinical management Resources Assessment Promotional & Informational Materials are available Future Trends New VA/DoD PTSD CPG Measurement Based Care Technology VA partnerships with the community Continue training, research and clinical missions with some changes 11

12 Rothbaum (2006) Forbes (2010) VA PTSD CPG (2010) Batki (2014) Schneier (2015) Seal (2016) Alexander (2016) Lee et al. (2016) References Questions? 12

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