E-drug: Patient information leaflets (cont'd)
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How to write Patient Information Leaflets, PILs (they have other
names in other countries) depends on whether you are trying to be
informative or to fulfill regulatory demands. It is difficult to achieve
both at the same time.
The EU legal requirement for Patient Information Leaflets is named
Guidelines on the Packaging Information of Medical Products for
Human Use Authorised by the Community, August 2002. From page
8.
http://pharmacos.eudra.org/F2/eudralex/vol-2/C/bluebox_082002.pdf
This is difficult reading. I suggest you do Google-search with Patient
Information and the generic names of the substances. You should
then be able to find examples you can work with, and then compare it
with the regulatory requirements.
The hard part is to write information that is effective. David Sless at
Communication Research Institute of Australia, CRIA,
www.communication.org.au has been a pioneer in developing user
testing of medicine information. Prior to the FIP congress in Sydney
in September there is a two days workshop just on these things.
I have a website on labeling of medicines but it is not so much about
package inserts.
Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
stein@lyftingsmo.no
www.lyftingsmo.no
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