Patient information leaflets on over-the-counter (OTC) medicines: the manufacturer's perspective

A survey was undertaken to assess the views of the manufacturers of over-the-counter (OTC) products about (i) the value of patient information leaflets (PILs), (ii) the recent European Community directive relating to PILs and (iii) the procedures which are in place for producing and testing PILs. Although approximately half (15/31) of the respondents (response rate 31/58) thought that PILs were more important for OTC than prescription only medicines, this view was not unanimous. A majority (18/28) thought that the new EC directive would provide too much information to patients although only a small number (2/27) thought that the regulations were unnecessary. Indication for the product was thought to be the most important information for the immediate outer packaging. Only about one-third (35%) of patients are thought to read PILs, in contrast to the majority who read the outer packaging. A wide variety of departments contribute to preparing PILs. The marketing department had a major input particularly with respect to layout and testing of leaflets. On the whole the design and production of PILs involves considerable effort but their testing appears less structured and thorough.