Patient info leaflets found lacking

By Anna Lewcock

- Last updated on GMT

Related tags: Pharmacology

A study into the effectiveness of written information supplied with
drugs in patient information leaflets (PILs) has found the inserts
wanting, with complicated language, bad design and a lack of
appreciation for the end-user's concerns.

The study, conducted by a number of UK-based researchers and published in the journal Health Technology Assessment​, surveyed a variety of reports and involved patient groups to establish the effectiveness and value of the information leaflets. "Most people do not value the written medicines information they receive,"​ said the report, headed by Prof. Theo Raynor at the University of Leeds. "The poor quality of many leaflets tested, in terms of content and layout, may reflect the finding that provision, more often than not, did not increase knowledge." ​ The group found that there was little evidence to suggest that the information in the PILs affected compliance, seen as a key purpose of the inserts by professionals but not considered a primary function by patients. Indeed, some patients were reported to have seen PILs as merely serving to fulfil legal and regulatory requirements and protect manufacturers from medico-legal actions, rather than give any benefit to the consumers themselves. Despite the strict regulations and approvals involved in producing the written information in patient leaflets, some subjects in the study also questioned the credibility of the information from the pharmaceutical industry included in the inserts. While the researchers identified a clear gap between what patients ideally want in an informational leaflet and what is currently provided by the pharmaceutical industry, the researchers highlighted several measures that could be taken to address patient gripes with the existing products. For example, the team suggest using short, familiar words and sentences (instead of more obscure medical jargon), short headings that stand out, as large a font as is possible, bullet points rather than continuous text, and using a conversational tone of voice in the text. The study also noted that pictures or diagrams don't necessarily improve the document, and that cramming all available space on the page with information is another mistake - leave as much white space as possible on the PIL. The inclusion of PILs with prescribed medicines only became a statutory requirement in the EU in 1999, so it could be claimed that the industry is still getting to grips with communicating to patients all the necessary detail in an accessible way. Despite the fact the alternative media, such as the Internet, have opened up a whole host of doors for patients to access alternative sources of information about their medication, the research team state that "standardised package inserts remain one of the most important, and probably often the sole, source of written information about medicines available to patients." ​A number of parties with a variety of different (and possibly diverging) motives and agendas have a stake in the development of more effective written patient information, ranging from patients and professionals to government and the pharmaceutical industry. As far as the pharma industry goes, the research team warns that at present, PILs are a source of distrust in the eyes of patients, with the independence and reliability of information supplied by the drug manufacturers questioned. Potentially threatening to taint the industry as a whole, this suspicion on the part of consumers could seem to be addressed by a more open and 'human' approach to the production of PILs: "Pharmaceutical companies have a statutory responsibility to produce PILs in their current format and increased patient involvement in the development of leaflets would be one way in which the process could be made more transparent,"​ the study said. If manufacturers started to produce patient information inserts that were more consumer-friendly in terms of appearance, content and written style, it could conceivably follow that medical professionals and patients would be more likely to opt for those products over others with more complicated or intimidating written information - thus possibly securing the manufacturer a subtle edge in the market.

Related topics: Drug Delivery

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