opinion
This is the first in our series of opinion pieces highlighting the research undertaken by the School of Healthcare. Contributions from colleagues are encouraged, please send to n.howson@leeds.ac.uk
DK (Theo) Raynor is a graduate of the University of Nottingham and worked for the first 20 years of his career in hospital pharmacy practice. During this time, he gained his PhD at the University of Bradford, with work on medicines information for patients. In 1995 he moved into academia, to head the newly formed Pharmacy Practice Unit at Leeds. He became the inaugural Professor of Pharmacy Practice at Leeds in 2000. He is leading a spin-out company of the University of Leeds, which provides a user-testing service for the pharmaceutical industry for their patient information leaflets (www.luto.co.uk).
Medication literacy - meeting patients half way
Prof DK Theo Raynor
We hear a lot about health literacy but, what about "medication literacy"? After all medicines are the most common treatment in healthcare. I had this idea last year when asked to write an editorial for the Mayo Clinic Proceedings.[1] This editorial examined the issues raised by 2 US papers. The first showed that, after a hospital stay for acute coronary syndrome (for example a heart attack), over 20% of people hadn't filled their prescriptions and the same number had some difficulty understanding the purpose of their medicines. The second study also followed people up after discharge, and found that 14% weren't aware they had been given a new medicine and over one-third didn't know the name of the medicine or its purpose. 
After sales service for medicines?
Looking wider than just hospital admissions, there also appears to be a significant deficiency in the communication of information to people who get their medicines in the community - both from the pharmacist and their general practitioner. This has been my own personal experience - whenever I collect a prescription for myself or a family member from a pharmacy, I am never asked a question nor offered any advice, simply handed the medicine in a stapled or taped down bag. This is unfortunate, as our recent systematic review for the Health Technology Assessment programme showed that spoken information about medicines is a priority for patients. They would like written information as back-up, but spoken remains the priority.[2]
We need to, therefore, think closely about the "after sales service" that we give to people after we have given them a medicine. With most other goods that you receive there is a well defined process for after sales service - whether this would be through a telephone helpline or a "how to" instruction booklet. In the UK and across the European Union, the current mainstay for medicines information is the mandated leaflet which comes inside all medicine packs. Manufacturers providing such leaflets are legally required (since 2005) to test the readability of these leaflets on patients.
It is interesting that one of the studies mentioned earlier in the United States found that after discharge, about one-third of people didn't know who they would ask if they had any questions about their medicines. I wonder how we let this happen, whichever country is involved?
Golden moment?
It seems likely to me that there might be a "golden moment" after a new long-term medicine is started (a new medicine a person might then have to take for many years), when patients might be most receptive to information about that medicine - and might indeed have questions formulated in their mind. It is unclear when this moment occurs, but it is unlikely to be at the point when the medicine is very first prescribed, dispensed or administered. Maybe it is two or three days later when the patient is becoming familiar with the medicine, and their questions and concerns start to emerge. It is worth researching the role of an expert in medicines (most obviously a pharmacist) who would talk to a patient two or three days after they have had a significant medicine change. This could reinforce important information and give the patient an opportunity to ask questions. For many patients a phone call might be most convenient.
There is also a role for a formal medication review later on - to give people an opportunity to talk about their long-term medicines. Straightforward medication review is often simply someone going through a patient's list of medicines to check that there are no interactions or problems with the doses. Clinical medication review, first described and tested by our Leeds Medicines Management research team[3], involves actually talking to patients about the medicines they are taking, with the opportunity to improve their understanding and them able to ask questions.
Testing, testing
Going back to the written information people are given, if you are thinking about assessing the readability of any document, then I would caution against using what are called "readability formulae". These have names like the FOG or SMOG Index and they are, indeed, mathematical formulae which are based on the length of words and the number of words in sentences in a piece of text. The problem is that word length and sentence length are only two of very many things that impact on the readability of a document. When a piece of information is written backwards it has the same readability score as when written forwards: the words and sentence lengths are the same. Equally there are many short sentences with short words which are not easy to read, such as the phrase legally required on some UK medicine packs "Do not exceed the stated dose". Rather than such 'content-based testing', the European Union and Australian health regulators require 'performance based testing' of medicine leaflets. This means finding out if potential users of the medicines can find and understand the information they need to take the medicine safely and effectively.[4] This 'user-testing' is transforming the medicine information leaflets that are supplied with packs to patients in the UK and in the wider European Union. One of the main providers of such testing is Luto Research Ltd which spun out of the University of Leeds and was based on our research in this area (www.luto.co.uk).
"Poor responders"?
To return to the issue of health and medication literacy, we know that people with low literacy are more likely to be admitted to hospital, stay there longer when they are admitted and are less likely to take their medicines properly when back in the community. It is striking that, according to UK Department of Health figures, over half of UK adults don't have enough literacy skills to discuss their illness two-way with a doctor. I think we need to address health literacy from two angles. One of the US papers described above stated that there was "limited comprehension and understanding of medications; thus, functional health literacy of the study population was poor". I don't think we can say this - unless we are sure that the information presented to them (spoken and written) was worded, designed and delivered in a way such that they were able to access and take-in that information. You can't simply say that their health literacy was poor; rather their health knowledge was poor, but not necessarily their health literacy. We need to know if the information used simple words - or did it use official sounding words like "sought" and "interaction". By the way, I have never heard a patient talk about a medicine interacting with another medicine. They always talk about a medicine affecting another medicine, so that's the word we should use. We also need to use words that are respectful to patients. We recently tested for readability a clinical trial patient information sheet, for women who had undergone IVF. The trial was of second line therapy for people who had not responded well to the first therapy and was called the "Poor responders trial" in the protocol and information sheet for patients. It's vital that we don't talk about patients in such an unsympathetic way.
The systematic review I mentioned earlier included a review of principles to apply in good writing and information design when preparing medicines information for patients. [5] But it's not just about how information is written and designed, but did the actual content meet patients' needs? Did it include a balance of benefit and harm information? Information often just contains harm information - what might go wrong; what people shouldn't do, and so on. Our systematic review for the UK Department of Health mentioned above showed that people would prefer more information about the benefits of a medicine - to be balanced against the harm information.
So, considering whether people have so called "high or low health literacy" in isolation misses the point. The information given to them must be usable. In a recent editorial in the International Journal of Pharmacy Practice I noted that medicines are the most frequent intervention in the majority of health systems and without effective medicines use, most health systems would be largely impotent. This is why medication literacy is so important. [6] We need to meet patients half way by applying good practice in spoken and written information and then, crucially, applying performance based testing to make sure what is supplied actually meets patients' needs.
Open the box?
Of course, with our medicine leaflets, they are supplied inside each medicine pack. What would be great would be for pharmacists to "open the box", when they supply a long-term medicine to a patient for the first time. Using the leaflet as a guide would help the pharmacist to remember the important points to get across and at the same time demonstrate to patients that these leaflets are relevant to them and can be useful.
[1] Raynor DK. Mayo Clinic Proc 2008 Raynor, DK Theo, Medication Literacy Is a 2-Way Street.
Mayo Clinic Proceedings, 83(5), pp520-522, 2008
[2] Raynor, DK; Blenkinsopp, A; Knapp, P et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines.Health Technol Assess, 11(5), pp1-160, 2007
[3] Zermansky, A; Petty, D; Raynor, DK et al. Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice. British Medical Journal, 323(7325), pp1340-1343, 2001
[4] Raynor reference to add Raynor, DK Theo, Testing, Testing: The Benefits of User-testing Package Leaflets Regulatory Affairs Focus, pp16-19, 2008
[5] Raynor DK, Dickinson D. Annals of Pharmacotherapy 2009 Raynor, DK; Dickinson, D, Key principles to guide development of consumer medicine information--content analysis of information design texts. Ann Pharmacother, 43(4), pp700-706, 2009
[6] Raynor, D K, Addressing medication literacy - a pharmacy practice priorityInternational Journal of Pharmacy Practice, 17, pp257-259, 2009
