First EFIC® Symposium Societal Impact of Pain - SIP

Daniele Siviero
Paolo Daniele Siviero
Director of the Office for Pharmaceutical Policy
at the Italian Medicines Agency (AIFA).
Department 4 Economic Strategy and Pharmaceutical
policy – Office for pharmaceutical
policy
Therapeutic strategies for the treatment of
pain
In Italy, in recent years, have been approved a
series of rules to make easier the use of analgesic
opiod medicines in pain therapy.
A first step forward was done with the law
12/2001.
The main points of the law 12/2001 were:
1. new prescription pad for opioid medicine in
triplice copy
2. possibility to prescribe 2 opioid medicines
or 2 different dosage of the same medicine
for a therapy (maximum of 30 days)
3. home delivery of medicines included in the
Annex III bis.
The Ministerial Decree April 4 2003 introduces
simplification and modification to law
12/2001, for example prescription of active
ingredients associations one of which included
in the Annex III bis and facilitation of prescription
for doctors.
The Italian Medicine Agency (AIFA) has tried to
simplify prescription abolishing note AIFA number
3 for association codeine/paracetamole,
and since October 2009 it was abolished the
note AIFA number 3 and the medicine, subjected
to note 3, were therefore reimbursed
to the National Health Service without the limitation
provided by note.
Finally, it was adopted on march 2010 a new
very important law for pain therapy that introduce
a further simplification of prescription for
opioid medicines using National Service prescription
pad, but much more important the
creation of a network for treatment of pain
and palliative care on a regional basis.
In Italy the use of analgesic medicine for the
treatment of pain is much less than other EU
countries but there is the will to align Italy to
the rest of the world.
AIFA may reassensing the possibility of eliminating
the distinction beetween acute and
chronic pain, and the class of reimbursement
of such medicines.
In this presentation we have analized hospital
and territorial consumption and expenditure
for opiod medicines, NSAIDs and adjuvant in
recent years.
Is more difficult to estimate social impact and
cost related to pain because pain is the most
cause of absenteism from work, but seems
that treated patients costs to the society much
less than untreated patients.
Paolo D. Siviero
He is also in charge of the coordination of the
Area of the Italian Medicines Agencies related
to “Economic Strategy and Pharmaceutical Policy”.
He has been “intellectual property and knowledge
manager” at the Italian National Research
Council (CNR).
Coming from the private sector, he has been
CEO of companies in various fields.
Most recent publication:
P.Russo, F.S.Mennini, P.D.Siviero, G.Rasi “Annals
of Oncology” March 24 2010
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