# \[e-drug\] Patient information leaflets (cont'd) **URL:** https://talk.edrugplus.org/t/e-drug-patient-information-leaflets-contd/16911 **Category:** e-drug **Created:** [June 3, 2003, 5:40am UTC](https://talk.edrugplus.org/t/e-drug-patient-information-leaflets-contd/16911 "2003-06-03T05:40:03Z") **Posts on this page:** 1 **Page:** 1
### Author: ![stein](https://avatars.discourse-cdn.com/v4/letter/s/5f8ce5/32.png) [@stein](https://talk.edrugplus.org/u/stein) #### Post date: [June 3, 2003, 5:40am UTC](https://talk.edrugplus.org/t/e-drug-patient-information-leaflets-contd/16911/1 "2003-06-03T05:40:03Z")
E-drug: Patient information leaflets (cont'd) ------------------------------------------------------------------------- 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](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 -- To send a message to E-Drug, write to: e-drug@healthnet.org To subscribe or unsubscribe, write to: majordomo@healthnet.org in the body of the message type: subscribe e-drug OR unsubscribe e-drug To contact a person, send a message to: e-drug-help@healthnet.org Information and archives: [http://www.essentialdrugs.org/edrug](http://www.essentialdrugs.org/edrug)