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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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
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	
  
What	
  might	
  EPR	
  for	
  Pharmaceu#cals	
  	
  
           Really	
  Look	
  Like?	
  




   Extended	
  
   Producer	
  
 Responsibility	
  
     (EPR)	
  




                        16	
  
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	
  
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	
  
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	
  
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	
  
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	
  
Contact	
  




                 Scob	
  Cassel	
  
PSI	
  Chief	
  Execu#ve	
  Officer	
  &	
  Founder	
  
                  	
  617-­‐236-­‐4822	
  
       sco=@productstewardship.us	
  
        www.productstewardship.us	
  


                         22	
  
Pharmaceu)cal	
  Take-­‐Back	
  and	
  
the	
  Proposed	
  DEA	
  Regula)ons	
  
           April	
  2	
  –	
  4,	
  2013	
  
         Omni	
  Orlando	
  Resort	
  	
  
          at	
  ChampionsGate	
  
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	
  
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	
  
1. 	
  
The dea regulations_final
The dea regulations_final
The dea regulations_final
The dea regulations_final
The dea regulations_final
Clean	
  Water	
  	
  
               Safe	
  Communi#es	
  

Environmental	
  Reasons………	
  
Substance	
  Abuse	
  Preven#on	
  Reasons……	
  
Law	
  Enforcement	
  Reasons…..	
  
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	
  
Yellow	
  Jug	
  Old	
  Drugs	
  
 Program	
  Overview	
  
                   Non	
  Profit	
  Model	
  

                   Pharmacy	
  based	
  

                   Area	
  Served	
  

                   Number	
  of	
  par#cipa#ng	
  
                   Pharmacies	
  

                   55,000	
  pounds	
  collected	
  
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	
  
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”	
  
Substance	
  Abuse	
  Preven#on	
  Partners	
  
                Michigan	
  	
  
Rx	
  Be	
  the	
  Solu#on	
  Campaign	
  NMSAS	
  
www.drugfreenorthernmichigan.com/disposal.htmlaign	
  

h=p://www.barrycountysa}.com	
  

Royal	
  Oak	
  Community	
  Coali#on	
  

The	
  Alliance	
  of	
  Coali#ons	
  for	
  Healthy	
  Communi#es	
  
(ACHC)	
  
Links-­‐Website,	
  Map,	
  PSA’s	
  
•  h=p://www.greatlakescleanwater.org	
  

•  Par#cipa#ng	
  Pharmacy	
  Map	
  	
  


•  h=p://www.youtube.com/user/GreatLakesCleanWater	
  
Contact	
  Info	
  

Chris	
  Angel	
  
President,	
  Volunteer	
  Board	
  of	
  Directors	
  
Great	
  Lakes	
  Clean	
  Water	
  Organiza#on	
  
info@greatlakescleanwater.org	
  
www.greatlakescleanwater.org	
  
989-­‐736-­‐8179	
  
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	
  
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.	
  
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.	
  
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.
Societal Impacts
When Drugs Get Into the Wrong Hands


Easy access to prescription drugs has led to a growing
number of teens whom the Partnership for a Drug-Free
America refers to as Generation Rx.

Nationwide, 1.5 Million kids say they have abused
prescription drugs. The 2010 National Survey on Drug Use
and Health indicates that over 70 percent of Americans 12
and older who used pain relievers non-medically in the
previous year obtained the drugs from a friend or relative.

Emergency room visits are greater for prescription drugs
than marijuana and heroin COMBINED, according to the
Drug Abuse Warning Network.
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.	
  
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.

                   www.p2d2program.org
Disposal Options




                   Minnesota s Take it to The Box
                   program at participating police
                   stations.

                   Similar grassroots efforts are popping
                   up nation-wide.
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 www.disposemymeds.org
•    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.
The dea regulations_final
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.”	
  
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.	
  
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.	
  
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.	
  

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The dea regulations_final

  • 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   sco=@productstewardship.us   www.productstewardship.us   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.  
  • 32. Clean  Water     Safe  Communi#es   Environmental  Reasons………   Substance  Abuse  Preven#on  Reasons……   Law  Enforcement  Reasons…..  
  • 33. 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  
  • 34. Yellow  Jug  Old  Drugs   Program  Overview   Non  Profit  Model   Pharmacy  based   Area  Served   Number  of  par#cipa#ng   Pharmacies   55,000  pounds  collected  
  • 35. 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  
  • 36. 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”  
  • 37. Substance  Abuse  Preven#on  Partners   Michigan     Rx  Be  the  Solu#on  Campaign  NMSAS   www.drugfreenorthernmichigan.com/disposal.htmlaign   h=p://www.barrycountysa}.com   Royal  Oak  Community  Coali#on   The  Alliance  of  Coali#ons  for  Healthy  Communi#es   (ACHC)  
  • 38. Links-­‐Website,  Map,  PSA’s   •  h=p://www.greatlakescleanwater.org   •  Par#cipa#ng  Pharmacy  Map     •  h=p://www.youtube.com/user/GreatLakesCleanWater  
  • 39. Contact  Info   Chris  Angel   President,  Volunteer  Board  of  Directors   Great  Lakes  Clean  Water  Organiza#on   info@greatlakescleanwater.org   www.greatlakescleanwater.org   989-­‐736-­‐8179  
  • 40. 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  
  • 41. 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.  
  • 42. 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.  
  • 43. 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.
  • 44. Societal Impacts When Drugs Get Into the Wrong Hands Easy access to prescription drugs has led to a growing number of teens whom the Partnership for a Drug-Free America refers to as Generation Rx. Nationwide, 1.5 Million kids say they have abused prescription drugs. The 2010 National Survey on Drug Use and Health indicates that over 70 percent of Americans 12 and older who used pain relievers non-medically in the previous year obtained the drugs from a friend or relative. Emergency room visits are greater for prescription drugs than marijuana and heroin COMBINED, according to the Drug Abuse Warning Network.
  • 45. 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.  
  • 46. 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. www.p2d2program.org
  • 47. Disposal Options Minnesota s Take it to The Box program at participating police stations. Similar grassroots efforts are popping up nation-wide.
  • 48. 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 www.disposemymeds.org •  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.
  • 50. 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.”  
  • 51. 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.  
  • 52. 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.  
  • 53. 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.