Five weeks ago, the ANSM gave the green light to the temporary recommendation for the use of baclofen for alcohol addicts. Since then, 1,400 patients have signed up for patient monitoring via a portal on the net.
Five weeks after launching a temporary recommendation for the use (RTU) of baclofen for alcoholic patients, the Medicines Safety Agency (ANSM) made an initial assessment of the implementation of its electronic patient monitoring portal (www.rtubaclofene.org). “It’s rather a success”, confided this morning during a press briefing Dominique Maraninchi, director general of the Agency. Especially since the curve of doctors and patients adhering to the RTU, and registered on the site, is constantly increasing. “An increase that we hope to confirm and amplify soon as patients already treated with baclofen register on the RTU portal,” said for his part the Dr Florent Perin-Dureau, head of the central nervous system drugs division of the agency contacted by why actor.
Listen to Dr Florent Perin-Dureau, director of the ANSM: ” The increase in registrations on the portal is continuous and regular. “
1400 patients enrolled in five weeks
For the moment, 600 doctors prescribing baclofen have already registered on this Internet portal. However, half of these practitioners have not yet registered patients on the site. For the other half, these doctors follow an average of 4 alcohol-dependent patients.
On the patient side, the ANSM database now has 1,400 registered alcohol patients. Another interesting figure, almost a third of them (30%) have been started treatment since the issuance of the RTU. Only 5 patients have stopped treatment since their registration. In the end, the Agency recognizes that it is still struggling to convince health professionals to proceed with this rapid registration (2min) on its site since, according to health insurance, since 2008, more than 50,000 patients have had recourse. baclofen and 7,000 doctors have prescribed it outside of a real legal framework.
Maximum secure delivery conditions
Furthermore, regarding requests easing of the conditions for the delivery of baclofen, in particular those emanating from psychiatrists, the ANSM once again repeated that it had tried to set up a framework for delivery “as secure” as possible. This in order to avoid as much as possible the undesirable side effects of the known product (epileptic seizure, depression, etc.)
For this, the ANSM has in fact provided for a prescription in stages: from 120 mg / day, the doctor must seek a colleague more experienced in the management of alcohol dependence. From 180 mg / day or 120 in patients over 65, he will need the collegial opinion of a CSAPA or a hospital addiction service. And no matter what, RTU does not cover daily dosages over 300 mg.
Listen to Dr Florent Perin-Dureau : ” Our goal is not to please prescribers, but to ensure patient safety. “
In addition, to go even further in monitoring patients, the ANSM indicates that it will, in the future, do more to promote this electronic portal. Finally, the Agency also hopes that health insurance will be more severe towards patients and doctors who do not respect the legal framework. In particular by penalizing the reimbursement of prescriptions without marketing authorization (AMM).
Listen to Dr Florent Perin-Dureau : ” A certain number of prescribers are not yet aware of the existence of this portal. But, excluding AMM and RTU, baclofen should not be reimbursed. “
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