Most patients do not value the patient information leaflets (PILs) inserted in medicine packs, according to a NHS R&D Health Technology Assessment report published this week. The report is likely to prove influential: the authors presented their findings to the Commission on Human Medicines' Expert Advisory Group on Patient Information.

The report reviewed 64 papers reporting 70 studies and gathered opinions from experts in information design and stakeholder workshops, which included patients and patient groups. Based on this, they conclude that most people do not value written information about medicines and prefer verbal communication.

The report criticises PILs’ content and layout. Patients, for example, expressed concerns about “complex language and poor visual presentation." Patient’s value tailored information “set in the context of the particular illness of the individual patient." Patients also believed that the leaflets should also contain a balance of information about potential benefits and harm.

Perhaps inevitably, some patients questioned the credibility of pharmaceutical industry information. “Leaflets inserted in the medicine’s package may not be seen as trustworthy by patients when they are written by the pharmaceutical industry,” the report remarks. Patients in stakeholder workshops supported this view. The authors suggest that increasing patient involvement in the development of leaflets would help transparency.

Do PILs change behaviour?

The report also questions whether PILs change behaviour. For example, they comment that “more often than not” providing information did not increase knowledge. The authors failed to find any “robust evidence” that the information influenced patient satisfaction or compliance. Indeed, patients do not regard one of the PILs’ roles as improving compliance. This contrasts with some professionals who regard improved compliance one of the main roles of PILs. The study also revealed that some health professionals thought that patient information “should be brief and simple." Some professionals were ambivalent about written information and did not always actively recommend leaflets. Doctors admitted sometimes being reluctant to provide certain information, particularly about side-effects.

The authors called for more research into the value of the on-line Medicine Guides. In the pilot phase, guides for epilepsy, influenza and cholesterol, were available with a separate electronic leaflet for each medicine and hyperlinks to NHS Direct Online. A revised format is available for asthma medicines. “The findings of this review could be used to assess and develop further the existing format and content of Medicine Guides,” the authors suggest. “Studies of the levels of usage, role and value of this new source of patient information will be important while the programme is being extended to other treatment areas." Again, the report emphasises the importance of ensuring patients’ input throughout the development of web-based information.

All UK medicines must comply with new regulations to ensure that patient information is legible, clear and easy to use by 1 July next year. The authors suggest that “manufacturers should take full advantage of the new requirement to test such leaflets with target patient groups, to meet patients’ needs better."

In the meantime, the report suggests that health professionals should encourage patients to use written information and “welcome the questions this may raise." However, they stress that health professionals should ensure that written information is not a “substitute for discussion."

Reference:

Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess 2007;11(5).