NIDA Par9cipa9on in Major NIH Pain Consor9um Ini9a9ves

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1 NIDA Par9cipa9on in Major NIH Pain Consor9um Ini9a9ves David A. Thomas, Ph.D. Deputy Director, Division of Clinical Neuroscience and Behavioral Research, Na9onal Ins9tute on Drug Abuse NIH Pain Consor9um

2 Richard A. Denisco, MD, MPH

3 HERO Pain Registry Ini2a2ves: Pathways to Preven9on Conference on Opioids for Chronic Pain FDA- mandated post- market safety studies on opioids NIH Pain Consor9um Centers of Excellence in Pain Educa9on Na9onal Pain Strategy

4 Health Electronic Registry of Outcomes (HERO): Open Source PlaUorm for Measuring Health Outcomes Hero Pain Registry

5 Pain HERO: Ini9al and Follow- Up Surveys Demographics Pain Beliefs and Treatments Interac9ve Body Map PROMIS measures: Pain Intensity, Pain Behavior, Pain Interference, Fa9gue, Physical Func9on, Depression, Anxiety, Sleep Disturbance, Sleep Related Impairment Pain Catastrophizing Ques9onnaire (PCS)

6 Clinical Experience Clinical Experience

7 Clinical Pain Trial Control New treatment

8 The Future for HERO: Collabora9ons

9 HERO: The Future Ac9vity monitors Daily Experien9al Sampling Cell phone metadata Gene9cs

10

11 Problem About 100 million people suffer chronic pain in the US. Over 16,000 people die from prescription opioid overdoes in the US each year. There is not a consensus on when opioids are safe and effective. Opioids good!!! Opioids bad!!!

12

13 Pathways to Preven2on Process for Efficacy of Opioids for Chronic Pain NIH Final Report Evalua9on Commi`ee veang, forma9on Evalua9on Commi`ee delibera9on and report Pacific Evidence- based Prac9ce Center of Excellence Review and Report NIH and FDA NIH, FDA, CDC, SAMSA, OASH, AHRQ NIH, FDA, CDC, SAMSA, OASH, AHRQ, Outside Gov t stakeholders Pathways to Preven2on Conference Natcher, NIH Main Campus Sept Jan Aug Sept. 29 and 30th, 2014 Jan., 2015

14 General Topics: Key Ques9on 1: Pa9ent Popula9on Key Ques9on 2: Efficacy Key Ques9on 3: Minimizing Adverse Effects/Curtailing Treatment Key Ques9on 4: Short and Long- Term Benefits and Harm Key Ques9on 5: Risks of Addic9on

15 FDA- mandated post- market safety studies on opioids Purdue Pharma L.P. Mallickcrodt Pfizer Rhodes Endo Watson Zogenix Johnson and Johnson Boehringer- Ingelheim

16 risks of misuse, abuse, addic9on, overdose, and death associated with long- term use of opioid analgesics for management of chronic pain Develop and validate measures of the following opioid- related adverse events Conduct a study to validate coded medical terminologies Conduct a study to define and validate doctor/pharmacy shopping Conduct a clinical trial to es9mate the serious risk for the development of hyperalgesia following use of ER/LA opioid analgesics

17 NIH Pain Consor9um Centers of Excellence in Pain Educa9on

18 Experiences With Pain Ins2tute of Medicine Report Affects 100 Million Americans Indirect/direct medical expenses US $560- $630 Billion/year #1 reason people out of work

19 Education on Pain in Medical Schools Canada (median: 14) USA (median: 8) Canada (median: 14) Number of Schools Veterinarian schools: 87 hours on pain* Number of Hours of Pain Education Lina Mezei, B.S., and Beth Brianna Murinson, M.S., M.D., Ph.D *Watt-Watson J. et al., Pain Res Manag. 2009

20

21

22 Overall Goal: Improve pain treatment though educa9on 1) Develop and include pain educa9on in the CoEPEs curriculum 2) Develop online pain educa9on resource on the Pain Consor9um website (and others) 3) Dissemina9on/Evalua9on

23 Edna

24 Mrs. Farley

25 Ms. Mondragón

26 Tylee

27 Coming soon! 2

28

29

30 Na9onal Pain Strategy

31 Na9onal Pain Strategy Recommendation 2.2: "The Secretary of the Department of Health and Human Services should develop a comprehensive, population health-level strategy for pain prevention, treatment, management, education, reimbursement, and research that includes specific goals, actions, time frames, and resources."

32

33 15 recommenda9ons by June, 2014 Implementa9on star9ng in Fall, 2014

34 PAIN!!! POA!!! Improve Pain Treatment VERSUS Reduce Prescription Opioid Abuse

35 Improve Pain Treatment AND Reduce Prescription Opioid Abuse PAIN!!! POA!!!

36 HERO Pain Registry Ques2ons: Pathways to Preven9on Conference on Opioids for Chronic Pain FDA- mandated post- market safety studies on opioids NIH Pain Consor9um Centers of Excellence in Pain Educa9on Na9onal Pain Strategy

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