In March 2017, the Ministry of Health opened the portal report-health.gouv.fr with a view to allowing users to report online to the health authorities adverse effects related to the use of a medicine, a medical device or another health or cosmetic product.

An initial assessment shows that Signalement-sante.gouv.fr meets the public's expectations.

• Between March 13, 2017, the date of opening to the public, and January 31, 2018, 40,120 reports were received: 34,217 (85%) were from users and only 5,903 (15%) from healthcare professionals, both liberal and institutional.
• There were several spikes in reports over the nine months, including a particularly notable one in late August (up to more than 1,000 reports per day for several weeks), compared to the average of about 100 reports per day.
• This variation in the number of daily reports corresponds to specific cases that have been widely publicized, such as the change in the formula of Levothyrox.
• "The majority of reports from users are concentrated on products for which the patient is aware of the possibility of adverse effects, such as drugs and, to a lesser extent, medical devices.
• 81% of the reports concern drugs (32,649 reports), 6% concern medical devices, 4% concern serious adverse events related to care and 3% concern addictovigilance situations.
• "However, this last percentage must be qualified by the fact that a significant proportion of the reports sent to addictovigilance come from another vigilance (in particular pharmacovigilance and toxicovigilance)",observe the authors of the evaluation.

Low use of the tool by health professionals

• "While users have quickly adopted the reporting portal, health professionals seem to be little aware of its existence and still hardly use it," the authors of the evaluation observe.
• "The number of reports made by health professionals through the portal also fluctuates periodically, but to a lesser extent, around an average of 20 reports per day. One hypothesis would be that they are less sensitive to media trends on this or that health episode.
• At this stage, it is impossible to say whether this is a lack of appropriation of the portal by professionals or whether, more likely, the use of the portal simply does not reflect the lack of "reporting practice" of professionals, particularly doctors.
• It would be interesting to investigate the subject to appreciate the obstacles and, above all, the levers for strengthening the reporting practices of professionals."

Several needs for improvement of the portal were identified

Some of them have since been integrated into the portal. These include the creation of a user account for health professionals to track reports and access pre-filled forms. The other developments will find their place in the next versions of the portal.

See also:

My Health 2022: a collective commitment

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