Report from the HAI Seminar on Risk communication with patients 31. May 2006 in London
Andreas Wulf

This seminar was a by-product of HAI Europe’s participation in the Working Group with Patients’ and Consumers’ Groups in the European Medicines Agency (EMEA), the Regulatory Body for registering medicines in the EU, a parallel structure to the Drug Regulatory Agencies (DRA) in every EU Member State1.

One area of work of this Working Group is Pharmacovigilance, information and communication about safety issues, Adverse Drug Reactions (ADR) of medicines and reporting systems for ADR.

The issue of communication with the public and patients about the positive and negative effects of medicines involves both patients’ and consumers’ groups and so HAI Europe arranged an additional seminar in London for the members of this Working Group who came together for the EMEA meeting.

UK Consumers1 Association ['Which?'], who have a long history of working on patient information, generously agreed to host this seminar on 31 May.

12 participants from different patients’ organisations (International Patient Organisation for Primary Immunodeficiencies, International Alliance of Patients Organisations, European Cancer Patient Coalition, International Diabetes Federation) and consumer organizations (Which?, Danish Consumer Council, Health Action International Europe) and the European Public Health Alliance participated.

Three short presentations opened the Seminar:

  1. Andrew Herxheimer from HAI Europe (and also a co-founder of the UK patient information project DIPEx ; www.dipex.org) talked about the necessary interaction of written and spoken information in communication between health professional and patient. He stressed the point that any information has to be “user tested” and will always need to be put into the concrete context of the patient – e.g. side effects that seem tolerable for one patient may not be for another.
    Andrew Herxheimer Presentation
  2. Margrethe Nielsen from the Danish Consumer Council (www.fbr.dk) presented data from a consultation within their membership about information on ADR through General Practitioners. Interestingly, 40% of the DCC members responding to the questionnaire were taking medicines themselves. Most respondents requested information about serious and/or frequent of ADRs to medicines, but only a third of all GPs would always provide it, and a quarter would rarely do so. The short consultation time (7 min average) seems to be part of this problem, but many doctors seem to believe that too much “frightening” information about ADRs and possible harm from the medication could put patients off using what they recommend.
    Margrethe Nielsen Presentation
  3. Hildrun Sundseth from the European Cancer Patient Coalition (www.cancerworld.org) reported the results of a keypad voting session within their coalition of cancer patients groups on a range of questions on patient information. Clearly the problem of finding the appropriate information that exists but may be difficult for cancer patients to access, (e.g. information about ongoing trials with new medicines) came up as well as the role that primarily doctors, and in the second place patients’ groups, play as sources of reliable information. In contrast, only a minority of (cancer) patients so far get information from the internet.
    Hildrun Sundseth Presentation

    4. There followed a lively debate. Views differed on conceptualizing and communicating the potential benefits and harms (side effects, ADRs) of medicines to patients. Most of the Patients’ organisations representatives preferred the customary risk/benefit terminology while others saw risk rather as the probability of harm (which should be compared with the probability of benefit of taking the medicine). was by Some attributed this difference of view to language - in German the word 'harm' [Schaden] feels too strong and may suggest legal liability, while others emphasized that a medicine was always developed with the intention to bring a benefit, though of course the benefit had to be weighed up against the risk of potential side effects. This weighing up depended both on the seriousness of the side effects and the seriousness of the disease to be treated.

    But the group agreed that any positive and negative effects of medicines should be seen in a multidimensional perspective – not only including the probability of such unwanted and potentially damaging events but also realising that particular side effects can differ in importance for different people (e.g. taking a drug that makes driving illegal will matter enormously to a someone who has to drive as part of his/her work, but not someone who has no driving licence).

    Some practical conclusions and suggestions were collected at the end of this fruitful seminar and used in the discussion at the EMEA the next day. The group will consider holding adjunct seminars in the future to further the debates and discussion among the patients’ and consumers’ organisations.

    HAI Europe wants to thank all participants, and especially the presenters and the host for making this seminar successful

    Some Additional links on the issue of risk communication with patients

    1 to date, the EMEA is responsible for registration of only a small number of all drugs in the EU, mainly medicines in the field of oncology, AIDS, diabetes, neurodegenerative diseases and orphan drugs (medicines for rare diseases), this scope will be enhanced by 2008 to medicines for viral and autoimmune diseases. Most other medicines (especially most generics) are still registered via one national Authority and then the other Member States of the EU open their markets for this product through a procedure called “Mutual Recognition”.