INDICES> Package inserts & Patient Information Leaflets

[Carlos Vidotti <vidotti@cff.org.br>]

INDICES> Package inserts & Patient Information Leaflets
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Dear colleagues,

The Ministry of Health of Brazil / Health Agency has published a
public
consultation about a new proposal of drugs package inserts. This
proposal
include "similar" information to patients and to health professionals,
that
means, we will have two texts: a package insert itself (for patients)
and a
drug monography (to health professionals). The ensemble of drug
monographies will  be published in a formulary (like PDR).
I understand that drug monography has excellent models.

My question is related to the package inserts (for patients). So I'm
asking
for help regarding the information that should be included in package
inserts (for patients): contents, extent, language, order of
information
(e.g.: warnings first), pictograms, etc.

In addition, I would like to receive suggestions about scientific
literature in this matter and, if possible, country/local experiences
(right and wrong).

Thank you very much for your attention and help.

Best regards,

Carlos Vidotti

----------------------------------------------------------------------
----
Mr. Carlos Cézar Flores Vidotti
Pharmacist  MSc  <vidotti@cff.org.br>
Federal Council of Pharmacy  - CFF
Brazilian Drug Information Center  - Cebrim
Brazilian Drug Information System - Sismed
SBS Q. 1 Bl. K Ed. Seguradoras 8º andar- Brasília-DF - 70.093-900 -
Brazil
Phone: (55 61) 321-0555 / 321-0691  Fax: (55 61) 321-0819
Home-page: www.cff.org.br/cebrim  E-mail: cebrim@cff.org.br



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