Legislation: Shortcomings

Some shortcomings in the European legislation

The current European legislation provides the freedom to apply the principles of good information design. One of the main principles is included in article 63 of Directive 2004/27: ‘enable the users to act appropriately’.

However, there are five issues that might hamper the introduction of information design principles.

1 – Information for patients only? The phrase ‘enable users to act appropriately’ is only applied to package inserts for patients. It would be really beneficial if this phrase is applied to all information about medicines. This includes the SPC, the packaging, brochures, patient education materials, websites, applications, devices and so on.

2 – Sequence? The current Directive dictates a specific order of the information. This predetermined sequence of information is often in conflict with the expectations of users. (‘Why do they put the instructions somewhere halfway down the page?’, ‘Why are the benefits and side effects not placed next to eachother?’). There is a suggestion that a standard sequence of information will be remembered by patients. However, there is no evidence that this ‘learning’ effect exists.

3 – Test patients only? The current legislation makes the involvement of patients in the development of package leaflets obligatory. Article 56 states ‘consultations with target patient groups’ and article 61 adds ‘assessments carried out in cooperation with target patient groups’. This is of course a laudable approach, but it limits the testing to patients. A lot of information about medicines is never seen by patients, for example in hospitals or in care homes. It would be very beneficial to test information about medicines on other users too. Pharmacists, doctors, nurses, elderly care personnel, carers have to deal with this information too, but are not involved in the development. Of course it is not necessary to test ‘everything in all situations’. Only the high risk situations need to be assessed.

4 – Criteria. The legislation mentions criteria that are very hard to quantify. Words like ‘full and comprehensible’, ‘clear and understandable’, ‘easily legible’, ‘clearly comprehensible’, ‘easily comprehensible’, and ‘easy to use’ are too vague to be usable in practice. None of these terms can be used in an assessment of the quality of information because they are dependent on the reader, the action, and the situation. What is understood by a pharmacist is not necessarily understood in a similar way by a patient. And what is easily legible for some might be very hard to read for others. The phrase of article 63 avoids these issues by focusing on the performance: information must enable users to act appropriately.

5 – Format. The legislation makes it obligatory to include a package leaflet, unless all the information can be provided on the outer packaging. And the legislation requires that all the information of the SmPC must be included. The consequence is that some package leaflets become very long. It might be worth considering to provide some information in the package leaflet, and provide the remaining information in a different format and/or in a different medium.

These five issues are very minor. There is very little in the legislation that prevents the development of information that would really ‘enable users to act appropriately’. However, it might be worth to consider:

  • allow alternative formats. Allow that some information is provided in the package leaflet, and other information is provided in different formats such as websites, telephone applications, brochures, and animations. [Of course, not for all medicines in the same standardised manner. The selection of the alternative format depends on the users, the actions, and the performance level that needs to be achieved.]
  • allow performance based criteria. Apply criteria that can be quantified.
  • allow to involve all stakeholders in the development and testing of information. The focus on patients remains very important, but it would be very beneficial to test packaging, information, and devices on pharmacists, nurses, doctors, carers too.
  • allow to change the sequence of the information if this is beneficial for specific users in specific situations.
  • allow information about medicines for patients to be integrated into an information strategy. It seems worthwhile to consider ‘all users of medicines information’ in a similar way and make sure that all users have access to all information that is relevant to them.