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The dea regulations_final


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Pharmacy Track, National Rx Drug Abuse Summit, April 2-4, 2013. The DEA Regulations presentation by Scott Cassel, Chris Angel and Phil Burgess.

Pharmacy Track, National Rx Drug Abuse Summit, April 2-4, 2013. The DEA Regulations presentation by Scott Cassel, Chris Angel and Phil Burgess.

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  • 1. Na#onal  Rx  Drug  Abuse  Summit   Pharmaceu)cal  Take-­‐Back  and  the   Proposed  DEA  Regula)ons   Pharmacy  Track  –  April  3,  2013   Sco=  Cassel,  CEO  and  Founder   The  Product  Stewardship  Ins#tute   1  
  • 2. Disclosure  Statement  Sco=  Cassel  has  no  has  no  financial  rela#onships  with  proprietary  en##es  that  produce  health  care  goods  and  services.    Chris  Angel  has  no  financial  rela#onships  with  proprietary  en##es  that  produce  health  care  goods  and  services.    Phil  Burgess  has  no  financial  rela#onships  with  proprietary  en##es  that  produce  health  care  goods  and  services.     2  
  • 3. Session  Learning  Objec#ves  1.  Iden#fy  the  basis  and  effects  of  the  proposed  DEA   regula#ons.  2.    Lay  out  the  impact  of  the  proposed  regula#ons.  3.    Construct  a  plan  of  ac#on  to  implement  the  DEA    regula#ons  and  pill  take-­‐back  programs  in  the  a=endee’s    community.   3  
  • 4. Topics  I  will  cover  today  •  The  Problem  –  Improper  Disposal  of  Pharmaceu)cals   •  Safety  issues   •  Environmental  concerns  •   The  Solu)on:  Pharmaceu)cal  Take-­‐Back  programs   •  Support  for  Take-­‐Back   •  Trends    -­‐  U.S.  and  interna#onal   •  Why  exis#ng  efforts  are  not  solving  the  problem  •  Overview  of  Product  Stewardship  and  Extended  Producer   Responsibility  (EPR)  for  Managing  Waste  Pharmaceu)cals   •  Legisla#ve  ac#vity  at  local,  state,  and  federal  levels  •  Overview  of  DEA’s  Proposed  Regula)ons  Regarding  the  Disposal  of   Controlled  Substances   4  
  • 5. Who  is  the     Product  Stewardship  Ins#tute?   •   Non-­‐profit  founded  in  2000   •  Memberships     47  States     200+  Local  governments   •  Partnerships  (95+)     Companies     Organiza#ons       Universi#es     Non-­‐US  Governments   •  Board  of  Directors:  7  states,    Global  Product  Stewardship  Council    4  local  agencies  (PSI  represented  on  Board  of  Directors)   •  Advisory  Council:  Mul)-­‐ stakeholder  (14  members)   5  
  • 6. The  Problem:  Drug-­‐induced  deaths  second  only   to  motor  vehicle  fatali#es  (1999–2007)   Source:  Na#onal  Center  for  Health   Sta#s#cs,  Centers  for  Disease  Control   and  Preven#on.  Na#onal  Vital   Sta#s#cs  Reports  Deaths:    Final  Data   for  the  years  1999  to  2007  (2001  to   2010).   6  
  • 7. The  Problem:  Prescrip#on  Drug  Abuse   Classified  as  an   “epidemic”  by  the   Centers  for  Disease   Control  and  Preven#on   7  out  of  10  prescrip#on   drug  abusers  obtained   their  drugs  from  friends   or  rela#ves   7  
  • 8. The  Problem:   Accidental  Poisonings  •  Startling  facts  from  the  Centers  for  Disease  Control  and  Preven)on:   •  In  2009,  76%  of  poisoning  deaths  in  the  U.S.  were  uninten#onal   •  In  2009,  91%  of  all  uninten#onal  poisoning  deaths  were  caused  by   drugs.   •  Among  children,  emergency  room  visits  for  drug  poisonings  (excluding   misuse  or  abuse)  are  twice  as  common  as  poisonings  from  other   household  products  (e.g.,  cleaning  solu#ons)  1   •  Between  2004  and  2005,  an  es#mated  71,000  children  (<18  years  of   age)  were  seen  in  emergency  rooms  due  to  drug  poisonings  (excluding   abuse  and  recrea#onal  drug  use).     •  Over  80%  were  because  an  unsupervised  child  found  and   consumed  medica#ons.  1   1Schillie  SF,  Shehab,  N,  Thomas,  KE,  Budnitz   DS.  Medica#on  overdoses  leading  to   emergency  department  visits  among   children.  Am  J  Prev  Med  2009;37:181-­‐187.   8  
  • 9. The  Problem:   Environmental  Concerns    •  Medicines  enter  our  waterways  via  a  number  of   channels:   •  Agricultural  run-­‐off   •  Human  excre#on   •  Improper  disposal  •  Effects  in  the  environment:   •  Aqua#c  impacts   •  Poten#al  contamina#on  of  drinking  water  •  Current  wastewater  treatment  plants  not  designed   to  remove  pharmaceu#cal  compounds     9  
  • 10. Pharmaceu#cal  Take-­‐Back  Programs  •  One-­‐day  “ Take-­‐Back”  events  operated  by:   •  Law  enforcement  (can  accept  controlled  substances)   •  Local  governments/Household  Hazardous  Waste  collec#ons   •  Community  organiza#ons  and  other  NGOs  •  Permanent  collec)ons  located  at:   •  Police  departments  (can  accept  controlled  substances)   •  Retail  pharmacies   •  Healthcare  facili#es,  community  centers,  etc.  •  Mail-­‐back  programs     •  Law  enforcement   •  Retail  pharmacies  (partnering  with  reverse  distributors)  –  for  a  fee   •  University  pilots  (e.g.,  University  of  Maine,  University  of  Wisconsin   Extension)   10  
  • 11. Support  for  Drug  Take-­‐Back  •  Drug  Enforcement  Administra)on  (DEA)   •  Held  5  Na#onal  Prescrip#on  Drug  Take-­‐Back  Days  since  2010     next  event  scheduled  for  April  27,  2013  •  Office  of  Na)onal  Drug  Control  Policy  (ONDCP)   •  Supports  drug  take-­‐back  as  part  of  its  Na#onal  Drug  Control  Strategy  •  Food  and  Drug  Administra)on  (FDA)   •  Worked  with  ONDCP  to  develop  guidelines  for  drug  disposal       recommends  disposal  via  drug  take-­‐back  programs  •  Environmental  Protec)on  Agency  (EPA)   •  Encourages  the  public  to  take  advantage  of  drug  take-­‐back  programs  •  43  states  directly  promote  drug  take-­‐back     •  Agency  websites  provide  informa#on  either  on  their  own  state  programs  and/ or  federal  DEA  Take-­‐Back  Days     11  
  • 12. Status  of  Pharmaceu#cal  Take-­‐Back  Programs  •  Over  500  take-­‐back  programs  currently  opera#ng  across  the  country,  but  the   majority  of  Americans  do  not  have  access  to  a  convenient  take-­‐back  loca#on   Results  from  Community  Medical  Founda:on  for  Pa:ent  Safety’s    Survey  of  Drug  Take-­‐Back  and  Disposal  Programs  (2009  ,  2010)   Collec)on  Method  of  Drug  Take-­‐Back   Primary  Funding  Mechanism  of  Drug  Take-­‐ Programs   Back  Programs     3%   Drop-­‐off  (Pharmacy),   53%   Self-­‐funded,  43%   8%   Drop-­‐off  (Police   9%   Sta#on),  19%   Sponsors,  26%   17%   22%   43%   One-­‐Day  Events,  17%   53%   Grants,  22%   19%   Other,  8%   26%   Other,  9%   Direct  Mail  Back,  3%   N=  562  (some  respondents   N=  926  (some  respondents  selected   selected  mul:ple  methods)   mul:ple  sources)   12  
  • 13. Why  aren’t  exis#ng  efforts     solving  the  problem?  PSI  developed  Key  Elements  of  Pharmaceu)cal  Collec)on  and  Disposal  Programs:  A  Vision  for  the  Great  Lakes  Region  •  In  order  to  protect  public  health  and  the  environment,  programs  should  be:   •  On-­‐going   •  Free  at  the  point  of  delivery  for  disposal   •  Convenient   •  Secure   •  Able  to  accept  all  drugs  from   •  Widely  promoted   households  •  Programs  should  minimize  impact  on  the  environment  by  ensuring  collected   medicines  are  properly  destroyed  according  to  exis#ng  regula#ons.  •  Programs  must  be  sustainably  and  adequately  funded.  •  Programs  should  iden#fy  and  address  the  underlying  drivers  that  contribute  to   pharmaceu#cal  waste.   13  
  • 14. What  is  Product  Stewardship?  A  policy  approach  that…  • Minimizes  health,  safety,  environmental,  and  social  impacts  • Maximizes  economic  benefits  of  a  product  and  its  packaging  • Considers  all  lifecycle  stages,  from  design  to  end-­‐of-­‐life  • Is  either  voluntary  or  required  by  law     14  
  • 15. What  is  Extended  Producer  Responsibility  (EPR)?   • Mandatory  product   stewardship   Product   Stewardship   • Producers  hold  financial   and  managerial   responsibility  for  post-­‐ Extended   consumer  products  and   Producer   packaging   Responsibility   (EPR)   • Central  tenet  of  product   stewardship   15  
  • 16. What  might  EPR  for  Pharmaceu#cals     Really  Look  Like?   Extended   Producer   Responsibility   (EPR)   16  
  • 17. Federal  Pharmaceu#cal  Stewardship  Legisla#on  Pharmaceu)cal  Stewardship  Act  of  2011    •  Introduced  by  Congresswoman  Louise  Slaughter  (NY)  •  First  federal  EPR  bill  on  any  product  •  Would  create  “Na#onal  Pharmaceu#cal  Stewardship   Organiza#on,”  with  Directors  appointed  by  EPA,  to   implement  a  na#onal  EPR  program  •  Rep.  Slaughter  plans  to  re-­‐introduce  in  2013   17  
  • 18. Pharmaceu#cal  Stewardship  Legisla#on   State  Level  Bills  introduced:       California  (2013)           Florida  (2009)       Maine  (2010)       Maryland  (2010)       Minnesota  (2010)       New  York  (2011;  2013)       Oregon  (2009)       Pennsylvania  (2012)       Washington  (2011)   18  
  • 19. Local  Approach  to  Pharmaceu#cal  Stewardship  •  Na#on’s  first  local  EPR  law,  first   pharmaceu#cals  EPR  law  •  Requires  pharmaceu#cal   manufacturers  to  finance  and   manage  a  take-­‐back  program   for  unused  and  expired   medica#ons  •  Industry  lawsuit  claiming  law   violates  the  Interstate   Commerce  Clause    pending   19  
  • 20. Secure  and  Responsible  Drug  Disposal  Act  •  Passed  by  Congress  in  October  2010  to  provide  a  framework   for  allowing  the  public  (i.e.,  ul#mate  users)  to  dispose  of   their  lesover  and  expired  controlled  substances  safely  and   securely  (more  flexibility  &  less  costly)   •  Amends  the  Controlled  Substances  Act    •  Drug  Enforcement  Administra#on  (DEA)  to  develop   regula#ons  regarding  the  disposal  of  controlled  substances   •  January  2011  –  public  hearing  held  in  Washington,  D.C.   •  December  2012  –  DEA  issued  proposed  rule  [Docket  No.   DEA  -­‐316];  comment  period  closed  February  19,  2013   20  
  • 21. DEA  Proposed  Rule     Disposal  of  Controlled  Substances   DEA  proposed  to  expand  collec#on  op#ons  for  the  disposal  of     controlled  substances  to  include:  1.  Take-­‐back  events  –  conducted  by  law  enforcement  agencies  only.  2.  Permanent  collec)on  sites  –  operated  by  DEA-­‐authorized  retail  pharmacies,   distributors,  reverse  distributors,  law  enforcement  agencies,  or   manufacturers.  Retail  pharmacies  may  also  operate  collec#on  receptacles   at  long–term  care  facili#es  (“LTCFs”).  3.  Mail-­‐back  programs  –  operated  by  DEA-­‐authorized  manufacturers,   distributors,  reverse  distributors,  retail  pharmacies,  or  law  enforcement   agencies.   21  
  • 22. Contact   Scob  Cassel  PSI  Chief  Execu#ve  Officer  &  Founder    617-­‐236-­‐4822   22  
  • 23. Pharmaceu)cal  Take-­‐Back  and  the  Proposed  DEA  Regula)ons   April  2  –  4,  2013   Omni  Orlando  Resort     at  ChampionsGate  
  • 24. Topics  I  will  cover  today  1.  Understand  the  importance  of  drug  take-­‐back  programs  and  the  poten#al  role  for  pharmaceu#cal  stewardship  in  addressing  drug  abuse.  2.    Iden#fy  the  basics  of  DEA’s  proposed  rule  and  the  implica#ons  for  retail  pharmacies.    3.    Construct  a  plan  of  ac#on  to  par#cipate  in  a  drug  take-­‐back  program  in  the  a=endees’  community  following  requirements  proposed  by  the  DEA  
  • 25. The  Problem  •  Flushing  unwanted/unused  medica#ons  •  Associated  Press  Study  •  US  Geological  Study  •  DEQ  –  Michigan  Department  of  Environmental   Quality-­‐Other  State  Regulatory  Agencies  •  Prescrip#on  Drug  Abuse  •  DEA  –Controlled  Substances  
  • 26. 1.  
  • 27. Clean  Water     Safe  Communi#es  Environmental  Reasons………  Substance  Abuse  Preven#on  Reasons……  Law  Enforcement  Reasons…..  
  • 28. Clean  Water   Safe  Communi#es  We  Agree  on  that!  Let’s  Work  Together!  What  will  you  do  when  you  get  home  from  the  Rx  Drug  Abuse  Summit?  Yellow  Jug  Old  Drugs  Program  working  in  many  communi#es  to  provide  clean  water  and  safe  communi#es  
  • 29. Yellow  Jug  Old  Drugs   Program  Overview   Non  Profit  Model   Pharmacy  based   Area  Served   Number  of  par#cipa#ng   Pharmacies   55,000  pounds  collected  
  • 30. Yellow  Jug  Old  Drugs     Advantages  •  Pharmacy  based  and  easily  recognizable  •  Well  thought  out,  strict  protocol  •  Leverage  grant  funds-­‐Sustainable  aser  grants  •  Low  opera#onal  cost  /  Volunteers      •       Professional  Customer  Service  •  Free  publicity  –  News  stories,  Radio  and  Video  public  service   announcements  (PSAs)  •  More  a=en#on  on  collec#on  of  controlled  substances  in   communi#es  that  have  YJOD  •  New  DEA  Regs  to  allow  retail  pharmacies  to  accept  controlled   substances  
  • 31. Proposed  DEA    Regs  allow  Retail  Pharmacies  to  collect   controlled  Substances  •   Page  8  of  the  proposed  regula#ons     “authorized  registrants  that  choose  to   maintain  collec:on  receptacles  may  be   enhanced  by  increased  consumer  presence  at   their  registered  loca:ons  and  the  goodwill   that  develops  from  providing  a  valuable   community  service””  Page  86  “A  pharmacy   may  derive  tangible  benefits  such  as   addi:onal  revenue  from  increased  retail  traffic   to  the  pharmacy”  
  • 32. Substance  Abuse  Preven#on  Partners   Michigan    Rx  Be  the  Solu#on  Campaign  NMSAS  h=p://www.barrycountysa}.com  Royal  Oak  Community  Coali#on  The  Alliance  of  Coali#ons  for  Healthy  Communi#es  (ACHC)  
  • 33. Links-­‐Website,  Map,  PSA’s  •  h=p://  •  Par#cipa#ng  Pharmacy  Map    •  h=p://  
  • 34. Contact  Info  Chris  Angel  President,  Volunteer  Board  of  Directors  Great  Lakes  Clean  Water  Organiza#on  989-­‐736-­‐8179  
  • 35. Pharmaceu)cal  Take-­‐Back  and  the   Proposed  DEA  Regula)ons   Philip  P.  Burgess,  RPh,  DPh,  MBA  Chairman,  Illinois  State  Board  of  Pharmacy   April  2  –  4,  2013   Omni  Orlando  Resort     at  ChampionsGate  
  • 36. Topics  I  will  cover  today  •  1.              Understand  the  importance  of  drug  take-­‐ back  programs  and  the  poten#al  role  for   pharmaceu#cal  stewardship  in  addressing  drug   abuse.  •  2.              Iden#fy  the  basics  of  DEA’s  proposed  rule   and  the  implica#ons  for  retail  pharmacies.  •  3.              Construct  a  plan  of  ac#on  to  par#cipate  in  a   drug  take-­‐back  program  in  the  a=endees’   community  following  requirements  proposed  by   the  DEA.  
  • 37. Role  of  State  Boards  of  Pharmacy    •  Protect  the  health  and  welfare  of  the  ci#zens   of  their  respec#ve  state.  •  Ac#ve  involvement  in  drug  disposal  programs   by  pharmacists  can  have  significant  posi#ve   impact  on  pa#ent  safety  and  improve  pa#ent   care  •  Delicate  “balancing  act”  to  decrease  drug   diversion  while  improving  pa#ent  safety.  
  • 38. Unused patient medication in the U.S.•  Approximately 4 billion prescriptions are filled in the United States annually with an estimated 35%, or 200 million pounds go unused.•  Improper disposal of unused medications can adversely effect the environment•  Improper disposal or diversion of unused medications increases the risk of accidental poisoning and drug abuse.
  • 39. Societal ImpactsWhen Drugs Get Into the Wrong HandsEasy access to prescription drugs has led to a growingnumber of teens whom the Partnership for a Drug-FreeAmerica refers to as Generation Rx.Nationwide, 1.5 Million kids say they have abusedprescription drugs. The 2010 National Survey on Drug Useand Health indicates that over 70 percent of Americans 12and older who used pain relievers non-medically in theprevious year obtained the drugs from a friend or relative.Emergency room visits are greater for prescription drugsthan marijuana and heroin COMBINED, according to theDrug Abuse Warning Network.
  • 40. Why Pharmacists Should be Involved Pharmacists  are  posi#oned  to  play  a  huge  role   in  helping  properly  dispose  of  unused   medica#ons.   The  most  readily  available  health  care   professional  in  the  community.   It  makes  sense  to  return  the  drugs  from   where  they  were  ini#ally  purchased.  
  • 41. Disposal Options The Prescription Pill & Drug Disposal Program is a multi-state, collaborative effort between communities, local pharmacies, police departments, hospitals and city officials. Locations such as pharmacies and police stations can participate by setting up drop-boxes for the public to drop off their old or unused prescription drugs.
  • 42. Disposal Options Minnesota s Take it to The Box program at participating police stations. Similar grassroots efforts are popping up nation-wide.
  • 43. NCPA Dispose My Meds•  In 2010, National Community Pharmacy Association developed a program to promote pharmacists involvement with drug disposal.•  Pilot program in conjunction with the Iowa Pharmacy Association and the Iowa Board of Pharmacy.•  Participating NCPA members listed on•  To date: –  1,400 pharmacies participating –  70,000 lbs of drugs collected for safe disposal –  The Secure and Responsible Drug Disposal Act (S. 3397), legislation backed by NCPA will improve and encourage voluntary prescription drug disposal programs like the Dispose My Meds program.
  • 44. Impact  of  Proposed  DEA  Regula#ons    “These  regula#ons  propose  to  allow  authorized  manufacturers,  distributors,  reverse  distributors  and  retail  pharmacies  to  voluntarily  administer  mail-­‐back  programs  and  maintain  collec#on  receptacles.  In  addi#on,  this  proposed  rule  expands  the  authority  of  authorized  retail  pharmacies  to  voluntarily  maintain  collec#on  receptacles  at  long  term  care  facili#es.”  
  • 45. Impact  of  Proposed  DEA  Regula#ons    •  Allows  pharmacies  to  par#cipate  in  taking   back  controlled  substance  prescrip#ons  from   pa#ents  without  the  requirement  of  direct  law   enforcement  involvement.  •  Increased  access  to  pa#ents  for  the  proper   disposal  through  drop-­‐off  kiosks  in  pharmacies   or  use  of  various  mail-­‐back  programs.  •  Extensive  record-­‐keeping  requirements.  
  • 46. Impact  of  Proposed  DEA  Regula#ons    •  Although  most  state  pharmacy  regula#ons   mirror  DEA,  there  will  be  selected  states  that   will  require  changes  to  either  their  Pharmacy   Prac#ce  Acts  or  their  Rules  to  allow  the  taking   back  of  medica#ons  in  the  pharmacies.  •  Un#l  those  changes  are  enacted,  the  use  of   the  mail-­‐back  provisions  will  be  the  only   op#on  in  those  states.  
  • 47. Impact  of  Proposed  DEA  Regula#ons    •  Con#nues  to  allow  law  enforcement  agencies   to  voluntarily  conduct  take-­‐back  events,   administer  mail-­‐back  programs,  and  maintain   collec#on  receptacles.  •  NOT  ADDRESSED  in  the  regula#ons  is  the  need   to  be=er  educate  the  prescribers  to  minimize   the  quan##es  that  are  prescribed.