NVOLVING PATIENTS IN PATIENT INFORMATION LEAFLETS
3.4.1 Background
The European Commission Guideline on the Readability of the Label and Package
Leaflet of Medicinal Products for Human Use4
includes within it an example of a
user testing method. In drafting that document, the Commission reflected the
work of Professor David Sless5
and considered that diagnostic testing would best
demonstrate that patients could find, understand and act upon the safety
messages within leaflets. So far very little user testing has been carried out within
the UK, although for products centrally authorised for supply in all member states
across Europe a user test is recommended, but not required, prior to approval of
the leaflet