Could patient safety be further improved by enhancing the readability testing process for PILs, labels, sleevers and extending this to cover packaging and design? By Brian Johnson
“Doubts have been raised by some regulators about the readibility testing process and many remain sceptical over the way it has been implemented”
-Brian Johnson, Head of Product Information, Fulcrum Pharma
The last decade has seen a major change in the content of PILs in Europe. Patients are now better able to understand the key information they need to ensure that they take their medicine safely and correctly. However, doubts have been raised by some regulators about the readability testing process and many remain sceptical over the way it has been implemented. Some argue that the focus on getting a leaflet to pass a test does not necessarily produce a better leaflet and getting people to read the subject matter remains an issue.
European legislation Articles 59(3) and 61(1) of directive 2001/83/EC as amended by Directive 2004/27/EC has been established for a number of years and provides clear guidance for ‘Readability Testing of Patient Information’. This makes it mandatory across the EU to test PILs for new products and others where significant variation to the leaflet is required, with all leaflets to be tested by 2010. The MHRA in the UK went further requesting MA holders to submit tested leaflets for all products by July 2008. This forced MA holders, agencies and testing houses, to evolve an agreed process to test patient leaflets based on the EU Guidance.
While the readability testing of PILs is well defined, there are reasons to consider a review of the current EU guidelines and scope, based partly on the experience of inconsistent feedback on tests received from EU regulators. Experience is generally positive but there are many lessons to be learned that could benefit the process, such as using ‘signposting methods’ when designing a leaflet to help patients with the navigation of a PIL.
Outside Europe patient information is handled in various ways; for example in the USA, patients can receive several leaflets from the packaging, pharmacy and doctor. In an effort to reduce confusion, recent changes mean that a patient will now receive one PIL produced from the pharmacy computer. A similar system has also been implemented in Australia. However, following an evaluation in the UK, USA and Australia where this approach came last and the PIL was found to be less likely to get to the patient, the system is now under review.
Recent research in the USA suggests that approximately 25% of serious medication errors reported to the Institute of Safe Medication Practices (ISMP) were caused by confusion over packaging and labelling instructions. In Spain and France there are similar levels of errors reported, 28% and 33% respectively. It is clear that the same process of readability testing should be strongly considered for packaging and external labelling.
The following is an example where the testing of packaging information, can improve patient safety. A national product licensed in the UK; testing took place to assess the impact of new packaging designs which took into account the recent guidance from the National Patient Safety Agency in addition to feedback from the pharmacist community and patients interviewed. The new designs included better use of colour to differentiate product strengths and sufficient space to allow for pharmacy labels. The focus in this instance was to test if the new design made it easier for pharmacists and patients to distinguish between different strengths.
In summary, to maximise safe use of medicines by patients the process for undertaking readability testing of PILs and Labels needs to be improved across the regions, more iterative and informed and based on practical experience. Additionally to facilitate safer dispensing by minimising ‘picking’ errors, consideration should be given to extending existing regulations to cover packaging and labelling.
Brian Johnson, Head of Product Information, Fulcrum Pharma, has a wealth of readability testing experience working with leading international pharmaceutical companies and successfully delivered projects submitted to the majority of European agencies. These projects were based on a variety of readability tests for patient leaflets, labels and packaging using centralised, decentralised MRP and national submission procedures.