Trac Service's readability testing manager Sophie Hobson looks at patient leaflet readability requirements covered by the new EC Directive and due for implementation in 2008
With less than 24 months before all Patient Information Leaflets (PILs) in the UK have to comply with mandatory readability requirements as set out in Article 59(3) of Directive 2004/27/EC, the question of whether pharmaceutical manufacturers are on target to meet the deadline is one that is being asked more frequently.
Surveys have revealed that people in the UK want more medicines information than they currently get1, and that they value the PIL more highly than any other source except doctors and pharmacists.2
But the reality is that traditionally, the vast majority of PILs, while having content that was factually correct, did not present these facts and guidelines in a way that the patient could easily understand.
With the new regulations already in place for all new applications for Marketing Authorisations, which are affected by The Medicines (Marketing Authorisations and Miscellaneous Amendments) Regulations (SI 2004/3224) and the clock ticking towards the July 1, 2008 deadline for all medicines to comply with the requirements, the steps are in place to deliver improved PILs.
European Law now states: 'The package leaflet shall reflect the results of the consultations with the target patient groups to ensure that it is legible, clear and easy to use.3 The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority.4
But whilst improving PILs is something that the sector is committed to, the cost of achieving this goal is falling firmly at the feet of those involved in the manufacturing and marketing of pharmaceutical products.
It is estimated that there are 15,000 existing PILs in the UK which will have to go through user testing to comply with the regulations, leaving manufacturers facing not only a cost responsibility but a time issue that they simply cannot afford to ignore. With this in mind, whilst the actual compliance deadline is July 1, 2008, the real deadline that manufacturers should be aiming for is December 2007 to allow time for the submission to be assessed by the required authorities (in the UK's case the MHRA) and approval granted.
With the lack of submissions thus far made to the MHRA, there will undoubtedly be a backlog as pharmaceutical manufacturers seek to undertake the testing they need to make a successful submission. But are manufacturers winning the battle? Regulatory affairs specialist Trac Services believes that there is a high percentage of manufacturers that are falling behind.
Trac has set up a readability service for pharmaceutical manufacturers across the UK who have yet to start the process or are in the early stages of testing their PILs.
With the time and cost implications, it is essential that manufacturers establish a successful protocol for user testing that will maximise the chances of success for their submissions, which can then be carried forward through all of their PIL user testing. Trac's readability testing service helps manufacturers to achieve this important aim by adopting a clear process.
At Trac, we have seen some truly awful leaflets as well as a number of good ones. A big problem is the continued use of medical language. Before taking a PIL anywhere near a test group, it is vital that manufacturers look at the existing PIL with fresh eyes and evaluate the literature they are used to seeing constantly - this can be a major problem for pharmaceutical companies reviewing their leaflets.
The use of medical language has traditionally been commonplace and with the guidelines effectively demanding that manufacturers reinvent PILs, making fundamental changes is not always a straightforward process.
It is vital to take a step back and look at existing material critically and start to see where improvements can be made. It is important that the design and layout of the PIL has a natural flow to it, and also should have the following characteristics:
- Short sentences
- Short words
- Simple language
- Easily understood concepts
- Avoidance of unnecessary words
- Use of the active rather than the passive voice
- Emphasizing headings with different colours.
Writing the questionnaire can be the most difficult part of the process. With 90% of the people undertaking the readability test having to be able to understand the questions and find the answer to it within the leaflet, a good questionnaire is critical. Asking a slightly ambiguous question or indeed not asking a question about a key safety issue will not only hamper your chances of achieving the 90% success rate but it will also increase the costs as retesting will be required.
It is vital that when producing the questionnaire all of the key safety features are identified, included and ranked in order of importance. The questionnaire should include up to 15 questions and a set of expected answers should also be produced. Failure to identify a key safety feature at this point is highly likely to result in a failed submission so it is vital to get this process right.
This questionnaire should serve to act as an initial version which, upon completion, is pilot tested against a sample audience to enable any problem questions or ambiguities to be ironed out before the questionnaire goes live.
Demographic panel
With a leaflet ready for review and a questionnaire that covers all of the key safety features, the question of who to recruit and how to recruit them needs to be addressed. When looking at the people who you want to undertake the readability testing, it is essential to look at a demographic in relation to the drug being tested. If you are testing a drug designed for particular age groups - young children or old people - it is important that the readability group reflects the likely users.
Participants who potentially have the most difficulty with written information are extremely valuable within the user testing process, because if they can understand the questionnaire and provide the answers required, it is likely that the PIL will be easily understood by all users. Once the participant types have been identified, the recruitment process needs to begin.
Unlike drug trials where participants are paid, finding volunteers for readability tests is a far more difficult and extremely time-consuming process. In an ideal world pharmaceutical manufacturers would be able to tap into a ready-made pool of volunteers, matching their demographic requirement with the PIL to be tested.
This is where professional organisations such as Trac can help manufacturers save vast amounts of time and money by providing them with access to hundreds of volunteers who they have already sourced, screened and prepared. Without this organisational support, manufacturers should consider where they may get access to test participants and establish a recruitment campaign of their own.
Before diving in head first with a full test, a pilot test of the initial questionnaire with a sample group of the right demographic should be undertaken to ensure any problems with the questionnaire can be identified and dealt with. Once the pilot test generates the results required, the full readability test can be undertaken. Also, if the pilot test is a success then the results can be used for the submission by including them in the first phase of the testing process.
A successful test should be undertaken on a one to one, face to face basis, involving at least 20 participants in two rounds of 10, of whom 90% of are able to find the information displayed in the PIL when asked and are able to explain the information in their own words.
There is an art to volunteer testing and it is essential that those undertaking the testing are experienced and properly trained. One of the key factors is to quickly establish a rapport with the volunteers. It is vital to make them realise that it is the leaflet that is being tested and not them, that it is not a memory test and that they can use the leaflet as a reference at any time to find the answer to the question posed. Also, it should be made clear that there are no trick questions. With only 45 minutes in which to undertake the test, the questioner must be disciplined to keep the volunteers on track.
There is a need to consider how to most effectively convey the information gained to the authorities. Once a test has been concluded, copies of the protocols - including the questions asked, the responses offered, the interviewer's written observations and the different versions of the PIL tested - must be submitted to the MHRA for review. The report should also include an explanation of the choice of population consulted and a summary and discussion of results (subjects' answers, problems identified and revisions made to relevant package leaflet section).
Successful readability testing will save pharmaceutical manufacturers a great deal of time and money. By establishing a good protocol for user testing from the outset, manufacturers will increase their chances of a successful outcome which can then be replicated across the other PILs in the product portfolio that require testing.
However, for many manufacturers the expertise required to achieve this will not be held in house. It is essential therefore that where support is required, the relevant skills and expertise are brought on board to make the PIL testing process as efficient as possible.
With so many PILs requiring testing in the UK, the cost and time implications placed on manufacturers means that the sooner the processes are put in place to successfully achieve the required outcome the better.