ATOME  Report:  barriers  in  na3onal  legisla3on  and  how  to  overcome  them    Geneva,  Switzerland,  19th  May  2014  

   

Marie-­‐Hélène  Schutjens,  Marjolein  Vranken,  Aukje  Mantel,    

Utrecht  Ins+tute  for  Pharmaceu+cal  Sciences,  Division  of  Pharmacoepidemiology  &  Clinical  

Pharmacology,  Utrecht  University,  Utrecht,  the  Netherlands      

   The  research  leading  to  these  results  has  received  funding  from  the  European  Community’s  Seventh  Framework  Programme  [FP7/2007-­‐2013]  under  grant  agreement  n°  222994  with  the  overall  aim  to  improve  the  access  to  opioid  medica+on  in  Europe.    

Aims  and  methods      Aims:    

To  iden6fy  legal  barriers  to  accessing    

opioids  in  12  Eastern-­‐European  countries  and    

make  recommenda6ons  for  improvement      

Methods:    

An  external  analysis  on  na6onal  legisla6on    

using  a  template  based  on  the  WHO  Policy  

Guidelines  and  involving  3  reviewers.    

Results:  barriers  iden3fied  in  the  nine  categories  (11  countries)    

Opportuni3es  for  improving  access        Prescribing  

•  authorisa6on  to  prescribe  is  

restricted  /  permit  or  license  needed  

to  prescribe  

•  special  prescrip6on  forms  required  /  

mu6ple  copies  required  

•  limited  validity  of  prescrip6ons  /  

limited  treatment  period  per  

prescrip6on/  limita6ons  on  daily  

dosage  

Dispensing  

•  limita6ons  on  dispensing  privileges:  

special  permit  license  required  /  only  

designated  pharmacies  are  allowed  

to  dispense  opioid  medicines    

•  strict  requirements  for  storage    

•  administra6ve  requirements  for  

dispensing  

Opportuni3es  for  improving  access        Usage  

•  restric6ons  regarding  the  

possession  of  controlled  

medicines  by  pa6ents  

•  strict  requirements  for  

accessing  dependence  

treatment  

•  viola6on  of  privacy  

Language  

•  incorrect  use  of  defini6ons  and  terminology:  

abuse  vs  long  term  medical  use  /  misuse  vs  long  

term  medical  use  /medical  use  vs  abuse  /  

physical  /  psychological  dependence  /  tolerance  

•  s6gma6sing  language:  addicts  /  addic6on  /  

persons  addicted  /narco6c  drugs  vs  opioid  

analgesics  /dangerous  /  addic6ve  drugs,  poisons    

•  unclear  language  

Best  prac3ce  examples  Improvements  that  have  been  made  in  na6onal  legisla6on  during  the  ATOME  project        Estonia  à  legal  requirement  for  pharmacies  to  obtain  a  license/permit  to  be  able  to  

dispense  controlled  medicines  to  pa6ents  has  recently  been  removed.  

 

Lithuania  à  proposal  made  this  year  to:  

1.  allow  for  a  physician  to  have  20  blank  prescrip6ons  for  opioid  medicines  instead  of  10.    

2.  to  significantly  increase  the  amount  of  opioid  medica6ons  which  will  be  allowed  to  be  

stored  in  health  care  facili6es  from  7  to  60  days  of  supplies.    

 

 

 

 

Best  prac3ce  examples      Improvements  that  have  been  made  in  na6onal  legisla6on  during  the  ATOME  project        

 

Serbia  à  December  2013  Government  adopted  a  new  law  on  health  care  which  enables  

NGOs  to  provide  pallia6ve  care  officially  and  prescribe  all  medica6ons  in  the  same  way  as  

in  public  or  private  ins6tu6ons  

 

Hungary  à  December  2013.    The  requirement  to  prescribe  opioid  medicines  in  mul6ple  

copies  was  removed  

Conclusion and discussion  Ø  All  eleven  countries:  poten6al  barriers  iden6fied    

Ø  Research  M.  Vranken:  poten+al  barriers  found  in  the  Netherlands  

Ø  Similar  results  in  your  na6onal  legisla6on?  

Ø  Poten+al  barriers  iden6fied:  impact  in  prac6ce  unknown  

Ø  Difference  between  the  percep6on  of  barriers  between  policy  makers  

and  health  care  professionals?  

Ø  Some  recommenda6ons  for  improvement  have  been  implemented  

during  the  ATOME  project    

Ø  Lessons  learned  and  key  messages