6 months ago, the ANSM gave the green light to the RTU of baclofen for alcohol addicts. With 3,700 patients registered on the Internet patient monitoring portal, the figures are not taking off.
Almost 5 million French people have problems with alcohol. And when they consult, their doctor is often deadlocked. This is why the authorization to prescribe baclofen in alcohol dependence was more than expected. More than six months after launching a temporary recommendation for the use (RTU) of baclofen for alcoholic patients, the enthusiasm is not yet at the rendezvous. The Medicines Safety Agency (ANSM) made a progress report, at the microphone of why actor, on the implementation of its electronic patient monitoring portal (www.rtubaclofene.org). “It’s rather a success,” said François Hébert, deputy director general of the ANSM. “Especially since the curve of doctors and patients adhering to the RTU, and registered on the site continues to increase” reasonably “,” he added. But the Agency does not hide that it hopes that the number of doctors and patients will increase soon. Because today, it is clear that it is trampling.
A goal of 300,000 patients in 3 years!
Indeed, to date (September 17), only 1,100 doctors prescribing baclofen have already registered on this Internet portal. This is little compared to the more than 90,000 GPs in France, who most certainly have alcohol-dependent patients in their patients. In addition, just under half of these practitioners have yet to register patients on the site. For the other half, these doctors follow an average of 4 alcohol-dependent patients, says the Agency.
In the end, on the patient side, the ANSM database now has 3,700 patients.
Compared to the last report, it should therefore be noted that the increase is slight. At the end of June, 2,200 patients had signed up for patient monitoring via this portal on the net.
According to a source familiar with the matter, the various actors of this portal hoped for around 15,000 patients registered after 6 months of launch. The objective of 100,000 doctors and 300,000 patients on the portal within three years therefore seems difficult to achieve.
Faced with these figures, the Agency wishes to launch an appeal to the address of the doctors so that they continue to register with their patients on this electronic portal. Asked by why actor, François Hébert, Deputy Director General of the ANSM, reminds that the RTU aims to ensure a much better follow-up of patients through this portal. “A more secure framework than that of off-label prescription (1)”, he adds.
Listen to François Hébert, Deputy Director General of ANSM: ” It is important to remind physicians that this RTU exists. It allows better reporting of any adverse effects that could be observed with this treatment.. “
RTU: maximum secure delivery
In addition, the ANSM specifies that this RTU is an assurance for the patients to have a reinforced follow-up, in particular with dosages validated by the Agency. This in order to avoid as much as possible the undesirable side effects known (epileptic seizure, depression …)
As a reminder, the ANSM has planned 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 (2) or a hospital addiction service. Regardless, the RTU does not cover daily dosages over 300 mg.
So, to convince doctors who are still reluctant to join this RTU, the ANSM insists on the simplicity of the device. “It’s really not very complicated and registering a patient only takes a few minutes. In addition, when the patient returns for consultation, it is even simpler, ”claims François Hébert. A point of view that does not share some field doctors for whom the electronic portal is too complicated.
A portal too complicated according to pro-baclofen doctors
Also contacted by why actor, Prof. Philippe Jaury, coordinator of the Bacloville clinical trial conducted among private doctors, confides that these results are not surprising. According to him, this portal is an additional administrative constraint for doctors. “It is not at all in their operation to go on the Internet to enter the identity of their patient (only the initials of the name and the first name are noted, Editor’s note). In addition, this portal is not as simple as the ANSM says. You have to enter a whole bunch of data (previous treatments, results of blood tests, etc.). “
In addition, this general practitioner and addictologist emphasizes that this device does not reassure patients. “Some people simply refuse it because they don’t want their file to be entered on a portal. I have a lot of patients who are against even when they are told it is anonymous and secure. There is a certain paranoia around these databases on the Internet which can be hacked, ”he admits.
Listen to Prof. Philippe Jaury, coordinator of the bacloville trial: ” Doctors had to be better informed and trained beforehand. Communication on this site was not very well done. “
Finally, for the future, Professor Philippe Jaury thinks that the Agency will still struggle to convince health professionals to proceed with this registration. “And it is not the reimbursement of the product for those who fall within the scope of the RTU that will change the situation,” he explains. Because patients who receive prescriptions outside the AMM, and outside the portal, are also reimbursed. There is currently no control, ”says this specialist in baclofen.
According to him, the training in the prescription of baclofen should have been entrusted to field doctors who have long campaigned for the marketing of this drug. “It is up to them to transmit and train, without going through a portal which is more complicated,” he concludes.
According to health insurance, since 2008, more than 50,000 patients have been treated with baclofen, and 7,000 doctors have prescribed it outside of a real legal framework.
(1) Excluding marketing authorization
(2) Support and Prevention Care Centers in Addictology
.