Patient information leaflet
From Ganfyd
See patient information booklet for general case, not connected with drugs.
The patient information leaflet (PIL) is part of the package that makes up a licensed drug or medicine. It is a regulatory requirement in the EU that a licensed drug or medicine should have a PIL. The PIL lists the doses and the recognised indications and adverse effects of the product. It is required to be "simple information in the national language"'
Require performance-based user testing of leaflets in an electronically based format that is printed on demand.
The patient information leaflets (PiLs) required by the FDA presently provide all legally required data on the drug so are so technical that they provide an excellent resource for those interested in the important clinical trials, the chemistry of the drug etc.
Much research has gone into designing these over the years. The guidance for what goes into a new drug PIL is extensive. There is evidence, from Canada however that about a third do not adhere to typeface legibility[1]. Pubmed does not identify however any attempt to ask a random sample of the public in the USA and EU what they think of each others PILs. However the FDA apears to be considering moving to written Consumer Medication Information (CMI) along the Australasian and EU lines and an FDA document makes the points that best practice requires: [2]
- Input of patient representatives and patient organisations in developing design policy (eg details like manufacturer and excipients should be at end of leaflet not beginning)
- Input of researchers and information designers critical (eg consumers do not like the package insert method of delivery)
- Test what patients understand by wordings recommended (eg Patients grossly over-estimating the risk of side effects occuring if words like “very common”, “common“, “rare” are used[3])
- Infra-structure for delivery to the patient is in place, appropriate and resourced
See also
- The Internet resources page includes links to sites providing information for patients.
External links
- electronic Data Sheets, Summaries of Product Characteristics (SPCs) and Patient Information Leaflets (PILs) are available from the electronic Medicines Compendium.
- EU regulations EMEA web site
- FDA guidanceHuman drugs section FDA web site
References
- ↑ Chubaty A, Sadowski CA, Carrie AG. Typeface legibility of patient information leaflets intended for community-dwelling seniors. Age and ageing. 2009 Jul; 38(4):441-7.(Link to article – subscription may be required.)
- ↑ Raynor DKT. Docket: 2005D-0169 - Draft Guidance - Components of Useful Written Consumer Medication Information (CMI) FDA website accessed 7/11/06
- ↑ Knapp P, Raynor DK, Berry DC. Comparison of two methods of presenting risk information to patients about the side effects of medicines. Quality & safety in health care. 2004;13:176-80. (Direct link – subscription may be required.)
