David  A.  Thomas,  Ph.D.  Deputy  Director,    

Division  of  Clinical  Neuroscience  and  Behavioral  Research,  Na9onal  Ins9tute  on  Drug  Abuse  

 NIH  Pain  Consor9um  

NIDA  Par9cipa9on  in  Major  NIH  Pain  Consor9um  Ini9a9ves  

Richard  A.  Denisco,  MD,  MPH  1954-­‐2014  

 

Ini2a2ves:    HERO  Pain  Registry    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              

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

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)  

Clinical  Experience   Clinical  “Experience”  

“Clinical  Pain  Trial”    

Control  

New  treatment  

The  Future  for  HERO:  Collabora9ons    

HERO:  The  Future  

•  Ac9vity  monitors    •  Daily  Experien9al  Sampling  •  Cell  phone  metadata  •  Gene9cs  

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!!!  

       NIH,  FDA,  CDC,      

SAMSA,      OASH,  AHRQ…  

Pathways  to  Preven2on  Process  for  “Efficacy  of  Opioids  for  Chronic  Pain”  

   

NIH  and  FDA  

         

NIH,  FDA,  CDC,      SAMSA,      OASH,  AHRQ,  Outside  Gov’t  stakeholders  

Sept.  2012   Jan.  2013   Aug.  2013  

         

Pathways  to  Preven2on  Conference  Natcher,  NIH  Main  

Campus  

Jan.,  2015  

Evalua9on  Commi`ee  veang,  forma9on  

Pacific  Evidence-­‐based  Prac9ce  Center  of  Excellence    Review  and  Report  

NIH  Final  Report  

Sept.  29  and  30th,  2014  

Evalua9on  Commi`ee  delibera9on  and  report    

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  

FDA-­‐mandated  post-­‐market  safety  studies  on  opioids  

Purdue  Pharma  L.P.  Mallickcrodt  Pfizer  Rhodes  Endo  Watson  Zogenix  Johnson  and  Johnson  Boehringer-­‐Ingelheim    

2065-­‐1  “…risks  of  misuse,  abuse,  addic9on,  overdose,  and  death  associated  with  long-­‐term  use  of  opioid  analgesics  for  management  of  chronic  pain..”    2065-­‐2  “Develop  and  validate  measures  of  the  following  opioid-­‐related  adverse  events…”      2065-­‐3  “Conduct  a  study  to  validate  coded  medical  terminologies  …”      2065-­‐4  “Conduct  a  study  to  define  and  validate  “doctor/pharmacy  shopping”      2065-­‐5  “Conduct  a  clinical  trial  to  es9mate  the  serious  risk  for  the  development  of  hyperalgesia  following  use  of  ER/LA  opioid  analgesics…”  

NIH  Pain  Consor9um  Centers  of  Excellence  in  Pain  Educa9on  

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  

Education on Pain in Medical Schools

Canada (median: 14)

Num

ber

of S

choo

ls

Number of Hours of Pain Education

Lina Mezei, B.S., and Beth Brianna Murinson, M.S., M.D., Ph.D. 2011

*Watt-Watson J. et al., Pain Res Manag. 2009

Veterinarian  schools:    87  hours  on  pain*  

Canada (median: 14) USA (median: 8)

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    

“Edna”  

Mrs.  Farley  

Ms.  Mondragón    

Tylee  

2  

Coming  soon!  

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."

Na9onal  Pain  Strategy  

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

PAIN!!! POA!!!

Improve Pain Treatment VERSUS Reduce Prescription Opioid Abuse

PAIN!!! POA!!!

Improve Pain Treatment AND Reduce Prescription Opioid Abuse

Ques2ons:    HERO  Pain  Registry    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