* Dr Joe Collier is Professor of Medicines Policy, Department of Clinical Pharmacology, St George’s Hospital Medical School, London SW17 ORE, UK.
European Union (EU) legislation (Council Directive 92/97 EEC) stipulates that medicines dispensed in the Union must now be accompanied by printed information written for the patient. The information is generally provided in the form of a Patient Information Leaflet (PIL). A PIL reflects what the EU considers the “responsible” patient needs to know.
A recent commentary in The Lancet1 suggests that PILs are promoting prescriber competence since they serve to standardise the information conveyed during a consultation. In other words, they provide a standard of minimum prescribing competence - in practice if not in law - defined in terms of knowledge of the content of PILs, and of an ability to answer patients’ questions about the information they contain. Publicly available and set by those other than medical academics, this standard can be expected to apply to all teaching about medicines, and equally to doctors, nurses and dentists.
The Standards Committee of the General Medical Council in the UK has agreed that doctors prescribing drugs should be familiar with the information on a PIL and able to explain it. Since PILs contain extensive information, mastering a working knowledge of their contents is no easy task (see box). Implicitly, prescribers will also need to know too about prescribing outside the licensed indications, that is, information not contained in a PIL. The Standards Committee has said that it will support any initiatives to keep doctors informed and up to date, especially through medical education and programmes for professional development and training.
If PILs do become the basis for prescriber competence, ensuring that they are up to date, reliable, consistent, and user-friendly will be especially important. In the UK, PILs are currently drawn up by the licence holder (the drug company), and the Medicines Control Agency. Ideally, however, consumers, patients, prescribers, pharmacists and professional groups should also be involved in the process to ensure that the contents of PILs are appropriate. Indeed, PILs should be reviewed regularly by multidisciplinary teams. Additionally, the source of the various statements and claims made in the PIL could usefully be indicated, perhaps in a reference manual.
In the interest of encouraging consumer awareness and medical transparency, PILs should clearly be welcomed.
A consultation in a clinic in the Netherlands. European Union legislation on patient information leaflets may lead to improved prescriber/patient dialogue (Photo: W Lindwer)
1. Collier J. Patient information leaflets and prescriber competence. Lancet 1998 Nov 28;352:1724.
Mastering the contents of a patient information leaflet
European Union legislation requires that each PIL include:
• a lay-term equivalent of the contents of the summary of product characteristics;
• the product’s ingredient(s);
• dosage regimen(s);
• expected beneficial effects;
• warnings, contraindications and possible unwanted effects;
• interactions with other drugs or food;
• storage requirements;
• advice about what to do when doses are missed or an overdose occurs.
More on patient information...
UK survey shows NSAIDS patient leaflets unclear
* Dr Andrew Herxheimer is Emeritus Fellow at the UK Cochrane Centre.
The commonest serious adverse effect of non steroidal anti-inflammatory drugs (NSAIDs) is upper gastrointestinal bleeding, which results in thousands of hospitalisations a year. The risk varies up to 20-fold with the type and dose of NSAID.
A survey of patient information leaflets for 29 major NSAIDs listed in the British National Formulary shows that the leaflets do not effectively explain their safe use or warn about gastrointestinal side-effects. Specifically the survey asked if the patient information leaflet explained that:
• the NSAID relieves symptoms but does not influence the course of the disease;
• the use of high doses or of the strongest drugs to obtain complete relief increases the risk of serious adverse effects;
• if any stomach symptom occurs, the patient should stop taking the medicine or at least reduce the dose and seek advice.
Incomplete, unclear and inconsistent
Only four of the 29 leaflets clearly explained that the NSAID only relieves symptoms. None of them discouraged efforts by the patient to obtain complete relief with the drug. Thirteen of the 29 did not mention stopping the medicine if stomach symptoms occurred; 10 advised stopping only if serious symptoms occurred, such as bleeding or severe stomach pain; and six advised stopping and seeking advice if any stomach symptom occurred.
The study concludes that information in patient leaflets should be much more complete, clearer, and consistent for all NSAIDs. This requires urgent efforts by the Medicines Control Agency and manufacturers.