A year after the revelation of the Dépakine affair, the management of the AP-HP wanted to ensure that its doctors comply with the new recommendations.
A year ago, the Dépakine scandal broke out. Thousands of women exposed to an effective but teratogenic antiepileptic, and hundreds of children suffering from birth defects. Last summer, the state acknowledged that more than 14,000 pregnancies were exposed to sodium valproate. In 30 to
40% of the cases, the children would present neurodevelopmental disorders.
The consequences are such that the National Medicines Safety Agency (ANSM) issued new prescription conditions in May 2015. “Valproate should no longer be prescribed to girls, adolescents, women of childbearing age and pregnant women, except in cases of ineffectiveness or intolerance to drug alternatives”, indicated the health authority.
In those for whom these specialties are essential, the initial prescription is reserved for neurologists, psychiatrists or pediatricians. Doctors are also required to obtain a care agreement from the patient after having informed her of the risks associated with these drugs.
At the Assistance Publique-Hôpitaux de Paris (AP-HP), Martin Hirsch, director general of the Paris institution, wanted to know if his doctors comply with these new prescription rules. An audit was then carried out among the 10,100 physicians corresponding to all the AP-HP practitioners. The evaluation, in which more than 3,500 professionals participated, concerned all physicians regardless of their specialty and whether or not they prescribe valproate-based specialties.
Two-thirds of doctors make at least one mistake
The AP-HP indicates that among the 164 frequent prescribers, 65% declare at least one practice that does not comply with the recommendations. Among these errors, approximately 7% would be “unacceptable”, which “shows that certain recommendations are sometimes complex to implement in the hospital by the medical teams”, notes the audit mission. The latter noted that the main points for improvement concern the issuance of the consent form, and the conditions for the annual reassessment of the prescription.
At the end of this process, information on the rules of good prescribing practice for Depakine and other valproate-based specialties was provided to physicians.
In addition, on the basis of the findings made during this audit, Martin Hirsch and the president of the Establishment Medical Commission (CME) asked all hospitals on October 12 to withdraw any stocks of drugs that might still be present. in the services, the establishment of a nominal dispensation as well as the delivery of a copy of the care agreement.
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