Featured pharmaceutical scientist
Professor DK Theo Raynor
Professor of Pharmacy Practice, University of Leeds
Communicating information about medicines to patients is an important part of pharmaceutical science - without effective patient communication, the full potential of most medicines will not be realised - so the role of the patient should not be under-estimated. Professor Theo Raynor has pioneered patient-centred research in communicating such medicines information over the past 35 years. This research has informed significant improvements nationally, and internationally, in medicines labelling and wider written information accompanying medicines.
Working first as a pharmacist in hospital practice and then in academia, his goal has remained an informed patient - someone who can make good decisions about their medicines: which medicines are right for them, and how to take them safely and effectively. Theo's work has always retained a patient focus - asking patients about the nature of the information they would like, and then working with lay people to test such information - can they find and understand the information they need?
The most fundamental information is that which pharmacists write on the medicine container – the closest information to the medicine itself, and available each time the patient reaches for the container to take the medicine. Medicine label wordings used by pharmacists in the UK developed haphazardly, with no evidence of their effectiveness. This changed however, due to a collaboration with the widely respected British National Formulary, leading to a revised set of label wordings which are all evidence-based, thanks to testing by Theo and his colleagues.
Research has also influenced international medicines policy – notably the European Union policy on mandated leaflets now supplied in every medicine pack across Europe. The introduction in 2005 of mandatory 'user testing' of such leaflets with lay people resulted in a radical change in how medicines leaflets were regarded. The university spin out company which Theo founded led the way in rigorous application of leaflet 'user testing' - ensuring the leaflets were fit for purpose. This is through testing the leaflets with real people - not expert patients - but the ordinary people who take medicines day-to-day. Key to the process is that it is iterative and developmental – a draft is tested, good practice in information writing and design is applied to rectify the shortcomings identified, and the revised document itself is tested – have the revisions led to an improvement?
In the 10 years since user testing legislation was introduced, that company, Luto Research, has grown to be one of the most influential and largest providers of health information user testing in Europe, with bases in Leeds, UK and Poitiers, France. Luto clients include most of the Top 20 pharma companies internationally. The impact of Theo’s research and that of Luto is not restricted to medicine labels and leaflets. Other notable outputs include the booklet supplied to all patients in the UK taking the medicine Lithium – a very effective medicine for some serious mental health problems – but which can cause a number of problems if not used appropriately by patients. Theo and his Luto team refined and tested the booklet for the National Patient Safety Agency – now in use routinely across the country.
Work also includes making the patient information sheets for clinical trials fit-for-purpose. It is widely acknowledged that many such information sheets do not allow people to make informed decisions about taking part in a trial. The first clinical trial sheet tested was that previously used in the ‘Elephant Man’ clinical trial at Northwick Park Hospital in London – a revised document, developed as part of the testing, led to significant improvements in participants’ ability to find and understand key points of information.
The benefits of user testing are not just confined to when applied to leaflets for patients and the public – it can be used for any form of information, including web-based information (we have tested and improved the European Public Assessment Record (EPAR) Summaries prepared by the European Medicines Agency for patients), and for any target group, such as information for health professionals (we have tested and improved risk management materials to improve the safe use of innovative medicines by health professionals).
Theo’s current focus is the provision of ‘benefit’ information for patients about medicines – how likely is a medicine to benefit an individual patient? This forms part of a Worldwide Universities Network (WUN) collaboration with the Universities of Sydney, Wisconsin and Chapel Hill. He is also working as academic advisor to two European Commission funded research projects looking at the shortcomings of current medicine leaflets for patients, and how they can be improved – continuing his work to improve this crucial information for patients.