Seroxat User Group colluding with the enemy MHRA/GSK to agree changes to GSK's patient information leaflet

Seroxat User Group colluding with the enemy MHRA/GSK








Committee on Safety of Medicines
Working Group on Patient Information

Report on a focus group discussion of the Seroxat patient information leaflet

Wednesday 13 October 2004 at 14:30 at Market Towers



Facilitator:
Mary Chambers, Chief Nurse and Professor of Mental Health Nursing at South West London
& St Georges' Mental Health NHS Trust and a member of the SSRI Working Group of the


Committee on Safety of Medicines

Attendees:
Representatives from patient interest and user groups and MHRA Product Information
Unit/Post Licensing Assessment Group.



Aim:

The aim of this focus group was to obtain the views of attendees on a revised patient
information leaflet (PIL) for Seroxat (paroxetine) and whether this meets the needs of users
for written information provided with the medicine.



Methodology:
All sections of the PIL were reviewed to identify any areas where the information needs to be
clarified to ensure that the key messages are understood. Any omissions that need to be
included in the PIL were flagged. Time did not permit consideration of the validity of the
questions asked in the company-sponsored user test undertaken previously on the PIL.



http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con01/9476.pdf