Download La Presse Medicale September 2011, vol. 40, no. 9, p.790

La Presse Medicale September 2011, vol. 40, no. 9, p.790-792 (Editorial)
One more step towards pharmacovigilance 2.0
Integration of social networking data for more reactive pharmacovigilance
Jean-Arthur Micoulaud-Franchi
Pharmacovigilance, patients and Web 2.0
While pharmacovigilance has been based up to now on a joint monitoring system by, on one hand, the
pharmaceutical industry and, on the other, spontaneous reports from health professionals, [French]
Decree No. 2011-655 of 10 June 2011, relating to means of signalling unwanted effects which may
possibly be associated with medicines, extents access to the pharmacovigilance apparatus to patients
and patient groups [1].
Even though France is in second place among European countries for the number of reports of
unwanted effects (behind the United Kingdom), these reports are still not enough [2]. A number of
ways of improving the rate of reporting have already been suggested. The recommendations of the
‘Report on pharmacovigilance and governance of the medication chain’ of 22 June 2011 recapitulate the
Decree of 10 June 2011 in stating that “patients and patient groups should play a part in the practice of
pharmacovigilance” [1, 3].
Such involvement of patients is, however, often viewed with distrust [4. 5]. In order to check the quality
of the information, filtering by groups of users has thus been put forward [1]. The growth of social use
of the web – referred to as Web 2.0 – in the health field since it started in the 2000s [4-6], would allow
the proposals in the declarations of intent in the report [3] and the Decree [1] to be put into practice
efficiently and on a large scale, and the interest in these would not be limited to calming the media
frenzy aroused by the Mediator ® affair [3]. Integrating social networks into the sources of information
undoubtedly presents a number of problems, but is an essential move towards pharmacovigilance which
combines global improvement with an extended role for patients [1, 6].
The field of Health 2.0 and exploring the grey area
The world of healthcare is not in the forefront of exploring the resources of Web 2.0, which has already
been embraced by various sectors of business. Even if health professionals are not promoting the
collaborative tools of Web 2.0 on a grand scale, patients, for their part, are certainly consumers. The
freely accessible data on searches published by the Pew Internet & American Life Project show that 80%
of Internet users (in the United States) are interested in searching for information on health, and that
this is the third on-line activity after e-mail and using a search engine [7]. Of these Internet users, 24%
are seeking information relating to the safety of medicines [7]. In France, the Doctissimo site hosts
forums with the highest level of use. This model of organising communities of patients on the Internet is
far from being the only one. Other models organise medical information in a more structured way, such
as the iconic American site, PatientsLikeMe [6].
There are two salient characteristics of the use of Web 2.0 in the health field [5]. Firstly, the ease of
taking part (accessibility, anonymity) combined with the obvious benefit of sharing information among
ones peers, favours putting on-line a considerable volume of information generated by users, with clear
effects of scale.
Secondly, this information does not stay dispersed on the forums, but has a tendency to become
organised; it is accessible to search engines, ranked according to the interests of the users, and so on.
This collaborative use of the Web in the field of health thus achieves a sort of empowerment of the users
[6]. It gives access to a grey area of clinical knowledge, which is accessible only with difficulty through
the traditional tools of medicine. Clinical data, not controlled in the first place, are collected in a real-life
situation by the patients themselves [6, 8].
Pharmacovigilance linked to users
Taking into account patients’ reports of secondary effects, in the context of the networks of Health 2.0,
allows the sensitivity and reactivity of pharmacovigilance alerts to be improved, and the Decree of 10
June 2011 to be effectively implemented [1]. The questions concerning a social network focused on
pharmacovigilance relate firstly to the organisation of the social networks on which this
pharmacovigilance 2.0 is based, secondly to the methods to be developed for adequately analysing the
mass of data emerging from these networks, and thirdly the utilisation of these data and their
incorporation into traditional pharmacovigilance networks.
In the first place, patients putting data on to the web is much more widespread than groups, and it is
precisely their volume which increases their importance. Security and regulation of putting these data
on the web are essential, and call for specific software. Government agencies such as the [French]
Haute Autorité de Santé might be involved with these networks, although some examples in the Health
2.0 field show the possibility of effective regulation outside governmental authorities [6]. This
independence allows a multiplicity of platforms and adaptability of user functions, which are essential
characteristics of the social web [5].
Secondly, the example of Google “following the ‘flu” in which Google search data were collected to
provide an estimate, almost in real time, of the spread of the ‘flu epidemic shows the possibility of using
Web data within systems for health surveillance. Specific methodological tools, known as “data mining”
[3], need to be developed [6]. The examples of PatientsLikeMe [6] or of www.MediGuard.org [9] show
that it is possible to obtain high-quality data from this non-traditional source for a medicines
surveillance system. Thus, analysis of data from the www.MediGuard.org site has made it possible to
obtain “ecological” data on the tolerance of antipsychotic medications [9].
Thirdly, data from pharmacovigilance 2.0 must be integrated into the traditional organisations for
surveillance of medicines. “Quantitative health surveillance” which processes these data, for example
under the aegis of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
(ENCePP) [10], might be envisaged for assessing the relevance of these alerts and their distribution. The
model of the Vigibase database, managed by the WHO collaborating centre for international
surveillance of medicines, Uppsala, using methods for automated signal detection, could be taken as an
example [3].
Finally, exchange of information must be bilateral. If data from pharmacovigilance 2.0 are integrated
into traditional pharmacovigilance organisations, it is essential that the latter likewise inform the social
networks and the users in return about the safety of treatments which concern them.
References
[1]
JORF No. 0136 of 12 June 2011. Decree No. 2011-655 of 10 June 2011 related to means of
reporting by patients or approved groups of patients undesirable effects which could be related to
medications.
[2]
Hermange M, Payet A. Conditions of marketing and monitoring medicines – Medicines: restoring
confidence. Senate – Social Affairs Commission.
[3]
Bensadon AC, Marie E, Morelle A. Report on pharmacovigilance and governance of the
medication chain. Inspection general des affaires socials (IGAS); 2011.
[4]
Eysenbach G. Medicine 2.0: social networking, collaboration, participation, apomediation, and
openness. J. Med. Internet Res. 2008;10:e22.
[5]
Silber D. Medicine 2.0: the stakes in the participative medicine game. Presse Medicale
2009;38:1456-1462.
[6]
Brownstein CA, Brownstein JS, Williams DS, et al. The power of social networking in medicine.
Nat. Biotechnol. 2009;27:888-890.
[7]
Fox S. Pew Research Center’s Internet & American Life Project.
http://www.pewinternet.org/Reports/2011/HealthTopics
[8]
Naylor CD. Grey zones of clinical practice: some limits to evidence-based medicine. Lancet
1995;345:840-842.
[9]
Cascade E, Kalali AH, Mehra S, et al. Real-world data on atypical antipsychotic medication side
effects. Psychiatry (Edgmont) 2010;7:9-12.
[10]
Moore N, Begaud B. Improving pharmacovigilance in Europe. BMJ 2010;340:1694.
Translation: Tom Burnham, 30.9.2011