The Pharmaceutical Journal
Vol 275 No 7356 p12
2 July 2005

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User testing of PILs now mandatory

Legislation implemented this week makes user testing of patient information leaflets mandatory. Dawn Connelly finds out what this involves

Making medicines information easier for patients to understand took a leap forward this week when user testing of patient information leaflets became compulsory in the UK.

A review of European Medicines legislation in 2001 led to the requirement that user testing of all PILs would be mandatory in EU member states from 1 October 2005. The UK chose to introduce the legislation three months early, on 1 July, in order to coincide with the UK assuming the EU presidency.

The concept of user testing was first mooted in Australia in the early 1990s and it has now been mandatory there for over five years. The EU adopted the term “user testing” in its “Guideline on the readability of the label and package leaflet of medicinal products for human use” in 1999 and until now it has been voluntary in EU member states.

This week, the Medicines and Healthcare products Regulatory Agency issued guidance to marketing authorisation holders to help them decide how and when to apply a user test to PILs. The guidance describes user testing as “a performance based, flexible development tool which identifies barriers to people’s ability to understand and use the information presented, and indicates problem areas which should be rectified”. It provides an illustration of one method of user testing (see Panel) but says that other performance-based methods are equally valid and will be judged on a case by case basis.

Initially, pharmaceutical companies will be required to submit the results of user testing of PILs to the MHRA with all marketing authorisation applications for new drugs. However, by 2008 the MHRA will expect all PILs to have been tested, unless the marketing authorisation holder can provide justification for exemption. This will apply to PILs for branded products, generic products, parallel imports and herbal products.

User testing does not only apply to PILs: packaging and promotional material is expected to be tested. Although the legislation only specifies PILs, the MHRA guidance makes it clear that packs that do not contain PILs should be tested on potential users.

Theo Raynor, professor of pharmacy practice and director of research at the University of Leeds and a member of the Committee on Safety of Medicines patient information working group, says that the benefits of user testing are clear. “Patients will have the opportunity to test the leaflets themselves, and that can only mean that the leaflets will meet their needs better,” he explains. He adds that during his research over the past few years he has noticed a consistent message: patients believe the information they get about their medicines is focused on what the manufacturer or health professional thinks they need rather than what they actually need. User testing should resolve this.

The Association of the British Pharmaceutical Industry welcomes the new legislation. A spokesman for the ABPI told The Journal: “We have certainly been working on [improving patient information leaflets] for some time. . . it will help patients understand what the medicine is about and how to take it. That it is an area that we have been getting better at but this will push us into doing even better.”

Cost to the industry

However, the spokesman voiced concerns about the possible costs of user testing to the pharmaceutical industry. “We estimate the average cost to be somewhere in the region of £12,000 to £15,000 per leaflet. If you multiply that by the 20,000 products that are on the market then you are talking in terms of £250m — that is a substantial sum of money.”

Professor Raynor, whose university spin-off company is providing user testing services to the pharmaceutical industry (PJ, 11 June, p702), believes that testing of PILs is relatively cheap compared with testing of the drugs themselves. He says: “The user testing that the MHRA and the rest of the EU is suggesting is an extremely cost-effective method. It involves a minimum of 20 participants . . . and it has been shown to be, even with small numbers of participants, very effective in identifying problems with leaflets and how they might be rectified.”

The MHRA guidance states that, as knowledge and experience grows, it is likely that not all PILs will need to be user tested. Products may be exempt if the PIL for a similar product has already been successfully tested. However, in certain circumstances evidence of successful user testing will always be required. These are product switches, new chemical entities, medicines with a novel presentation or formulation and medicines with particularly critical safety issues.

Professor Raynor explains that the guidance does not say explicitly whether a new user test will be required every time a PIL is amended. However, he anticipates that the need for another user test will depend on the information that is added or deleted. “The key issue is whether the change in question is likely to be one of the 15 points that are most important for the safe and effective use of the medicine.”

The new legislation will ensure that the information provided to patients in PILs is legible, clear and easy to use, and this should hopefully lead to improvements in patient compliance.