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European Pharmaceutical Contractor

Mind the Gap

For many years, patients’ sole source of knowledge was their trusted GP, and thus what they recommended, went. As long as pharmaceutical companies could convince prescribers that their drugs were the best to prescribe, they were rewarded with sales. However, the explosion in publicly available information has changed the pharma/prescriber relationship for good. Doctors are now faced with ‘informed’ patients, who visit them armed with printouts taken from hours surfing the internet. Some 80 per cent of internet users look for health info online, making it the third most popular online pursuit, following email and using a search engine (1).

Furthermore, a survey of 178 cancer listserv users showed that 35 per cent chose the internet as their preferred source of health information – even ahead of their oncologist (2). However, these ‘facts’ that patients take from the internet are gleaned from a disparate array of sources, from the very general Wikipedia and Google to specialised sites aimed at healthcare professionals. Their quality and authenticity vary as widely as the internet itself. It is little surprise that doctors become exasperated by patients who have selfdiagnosed and appear only to demand the course of treatment they have ‘chosen’.

In response to this, the Association of the British Pharmaceutical Industry (ABPI) has attempted to protect the public and stem the flow of unregulated information through social media by issuing advice to pharmaceutical companies on appropriate and responsible behaviour. However, it is hard to imagine how regulatory agencies could police everything provided by these companies on the internet (even if they had the power to do so). In addition, a large amount of online information is not from pharmaceutical companies, but from private groups or individuals who are not bound by such advice. This leaves regulators facing an ever increasing tide of often inaccurate and potentially dangerous information aimed at patients, which is not regulated or approved.

Recognising Obstacles

The EMA has responded to this challenge by recognising the importance of patient information in its latest Risk Management Plan (RMP) update (3). The RMP is a complex document, but in brief it sets out what a product is and does, what is known about its safety, and what has been found in clinical trials, along with what has been found once the product is on the market (if applicable). The RMP also outlines all of the safety concerns, the company’s pharmacovigilance plan and risk minimisation measures (for example, what the company plans to do to monitor safety problems and how it plans to minimise them).

RMPs can be very large, complex documents and require a significant level of medical understanding to be able to navigate them. However, they are of crucial importance in the assessment of any medicine. In recognition of this, the EMA has included a specific annex aimed at patients. It comprises a ‘Patient Summary of the RMP’ and is intended to explain in lay terms the main points of the plan. This summary, aimed specifically at patients, has been made part of legislation, and so is part of the law.

In doing this, the EMA hopes to provide a patient-friendly document that explains in simplified medical and scientific language the risks that their medicine carries, along with the benefits it can provide. This strategy carries an added bonus. Not only will a repository of regulated and assessed information on medicines be accessible to patients, but by explaining to them clearly what their side-effects might be, and why it is important to take their medicines in the way they are designed to be taken, it is hoped that patient compliance rates will increase. Currently, 50 per cent of people do not take their medications as prescribed, and this is responsible for 10 per cent of all hospitalisations and over 125,000 deaths annually in the cardiovascular area alone (4). Additionally, it is hoped that such transparency will increase patient confidence in the pharmaceutical industry, and reduce the incidence of adverse effects caused by poor communication or misunderstanding of medicines – approximately 10 per cent of adverse drug reactions can be attributed to a communication failure between provider and patient (5).

In 2005, a Medicines and Healthcare Products Regulatory Agency survey that showed that the general public want far more information about their medicines than is currently available. The RMP summary for lay readers will certainly help to address that need if companies can indeed write them in patient-friendly language. The biggest problem with patient-intended documents written by pharmaceutical companies is that they continue to read like regulatory documents, and patients do not always understand the information they receive because it is often written at an excessively high reading level (6). After decades of having healthcare professionals and regulatory assessors as their primary target audience, the skills needed to write for patients are not always easily found in the pharmaceutical industry.

Importance of the Written Word

The need for appropriately written patient information is underlined by the fact that some 1.1 million people in England are functionally illiterate, and around 16 per cent of adults have lower literacy skills than those of an average 11 year old (7). This means that converting complex medical information into a form that can be understood by ‘average’ adults with no medical training is challenging. This is even more challenging when numeracy is considered – 1.7 million people are functionally innumerate – which is essential for understanding the risks and benefits of drug safety information (7). For example, it is known that people with a lower numeracy level make larger errors in interpreting side-effect risk information.

To ensure that these RMP patient summaries serve their purpose, the industry needs to focus on making sure they communicate at a level that the general public understands. It will be important to use medical writers who are trained to explain complex information to patients in a way that is understandable and easily accessible. It would be a shame to lose the momentum that the EMA is trying to create with these new summaries by continuing to just write a document full of regulatory jargon and hoping it will ‘do the job’. If pharmaceutical companies take up the challenge that the EMA has given them, and work with professional communicators to produce documents that truly improve the quality of the patient information being produced, the industry as a whole will benefit. This is a very important step towards closing the gap between pharma/doctor information and patient information, but however difficult, the rewards will certainly be worth the effort.


1. Visit: reports/2011/healthtopics.aspx
2. Tustin N, The role of patient satisfaction in online health information seeking, J Health Commun 15(1): pp3-17, 2010
3. Guideline on good pharmacovigilance practices (GVP), Module V – Risk management systems, EMA/838713/2011, issued 20th February 2012
4. Deshmukh PR and Wasankar SW, Medical expert system, Advances in Medical Informatics (2), pp10-13, 2012
5. Institute of Medicine, To err is human: building a safer health system (executive summary), Committee of Quality of Healthcare in America, 2000. Visit: php?record_id=9728
6. Davis TC, Ann Intern Med 145, pp887-894, Taylor J et al, Eur Respir J 2005, pp26:57
7. Skills for Life Survey 2003

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Lisa Chamberlain James is a Senior Partner and CEO of Trilogy Writing and Consulting Ltd, a specialised medical writing company founded in 2002. After receiving her PhD in Pathology, Lisa began her medical writing career in Cambridge in 2000. Since then she has also been involved in the European Medical Writers Association (EMWA); she is a member of its Educational Committee, a leader and assessor of workshops, has helped to produce the EMWA conference programme from 2010 onwards, and holds an EMWA personal development certificate. Lisa is also a member of TOPRA and a Fellow of the Royal Society of Medicine.
Lisa Chamberlain James
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