There is an increasing evidence base on how to effectively communicate information on the risks and benefits of medicines but, with a few exceptions, “the pharmaceutical industry has not kept pace with this in producing product information fit for the 21st century healthcare setting,” says the UK government.

Patients, healthcare professionals and regulators agree that, in an ideal environment, patient information leaflets (PILs) should follow the following principles – high quality, appropriately targeted, timely provision and balanced. However, the current European Union (EU) legislative framework does not enable the optimal application of these principles, Professor Sir Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), has told the European Commission’s Directorate General Health and Consumers (DG Sanco).

“The UK government view is that change is imperative in order to fill the legislative vacuum,” Sir Kent tells the Commission, which is currently reviewing shortcomings in product information for patients.

For some years, the MHRA’s Commission on Human Medicines (CHM) and its predecessor committee have had concerns about the quality of PILs. These are “the public face of the marketing authorisation [MA], and for many patients will be the only information they have about the medicines which they are taking,” but user testing finds that patients consider them to be too long, complex in language and off-putting, he writes.

Another quality issue is that, while signposting of patients to other sources of information is permitted under EU law, this is only a “permissive provision,” not a requirement, so few MA holders use it. But including additional information which is useful for the patient and consistent with the MA can improve the PIL, he says.

Legislative change could also enable information to be targeted, making it more relevant to patients and more likely to be effective as a risk-management tool, he goes on.

Personalised medicine is more likely to be used by patients, who value information which speaks to them about the issues which are important to them. But currently, many patients find that because much of the information – such as interacting medicines and pregnancy information – is not relevant to them, they do not readily see how the rest of it can be of interest, Sir Kent writes. 

Turning to the need for information to be timely, he notes that the current framework requires the leaflet to be made available in the box at the time the medicine is supplied to the patient. But because many patients believe this information is not directed to them as individuals, the PIL often remains unread, so “an opportunity for the medicine-maker to communicate with the medicine-taker” is lost.

There needs to be a requirement for the information to be available electronically as well as written, he says. The current EU legislation “is silent on this, and therefore patients who increasingly operate in the social media space are precluded from accessing the information in a format to suit their preferred means of communication. The legislation should reflect changing lifestyles and communication tools and enable the provision of information in formats and media suited to the individual patient.”

Finally, on the need for balanced information, he says that future legislation should require the possible benefits and the likelihood of harm to be communicated together. “This is essential if patients are to be able to reach a decision about which treatment option is best for them. The risks and benefits should be described quantitatively and any uncertainty should be clearly communicated,” he says.

Currently, some PILs do include information on the rationale for the product’s use, but these are in the minority, says Sir Kent. “Such information will only be included as a matter of course if the legislative framework is amended to require this,” he tells the Commission.
The UK government’s position is that the legislative framework has considerable power in setting out how information must be provided, but this framework relies on MA holders taking responsibility for delivering patient information which meets the four principles outlined, as well as “the letter of the law,” he concludes.

In particular, the UK government says that the EU legislation should:
- enabled personalised information, allowing for information hierarchy, so that users can drill down into detail as it applies to them;
- require the provision of information via new media, to ensure timely access at different points in the user journey;
- require a balance of information in the leaflet so the likelihood of benefit is put in the context of the likelihood of harm; and
- mandate signposting to other sources of information helpful to medicine users.