Ivermectine, hydroxychloroquine, azithromycin…: What does a doctor risk by prescribing these treatments in the covid?

"Doctors, take care of: it's allowed."This is the reassuring message that the supporters of early treatments are trying to send against the COVVI-19.Like the collective "Let the doctors prescribe", they encourage their colleagues to administer drugs that have not demonstrated their effectiveness in the COVVID according to the health authorities.

Hydroxychloroquine, azithromycin, ivermectine are part of it.Launched a few months ago, an empirical covid treatment protocol continues to circulate on the internet.He associates these drugs with homeopathic products, phytotherapy and acupuncture ... dangerous, estimated the order of doctors last February.And yet, nothing prevents doctors from prescribing it.But in the event of a glitch, they will have to assume all the responsibility before the ordinal justice and the courts.

Freedom of prescription ... supervised

In a practical sheet published on its website, the National Council of the Order of Physicians recall that practitioners benefit from a freedom of prescription (article 8 and 40du code of ethics and article L.162-2 of the social lasecurity code), including for drugs that have not received AMM (marketing authorization) or even ATU (temporary authorization for use) for certain therapeutic indications.This is for example the case of the ivermectin, an antiparasitic therapy."Outside MA is possible," it is even provided for by law, indicates order.

This freedom is however framed.The prescriber must first ensure that no drug alternative drugs are available.To date, this is the case with the COVID-19 for which no treatment has been recognized as effective by the scientific community.

The doctor who prescribes out of AMM is not safe from prosecution.Two cases may arise.

First, if he does not fulfill his reinforced information obligation towards his patient, defined by article L.1111-2 of the Public Health Code (CSP).He has a duty to remind him of the non-compliance of prescription in relation to his MA, the absence of therapeutic alternative to equivalent benefit, the risks incurred and the potential profits and finally the absence of treatment by treatment byhealth insurance.The doctor must also justify his decision in the medical file (article L.5121-12-1 of the CSP).A sprain to this information obligation would open up to compensation.

Unjustified risk

The doctor can also be attacked if he runs an unjustified risk to his patients (article R.4127-40 of the CSP).He "cannot offer patients insufficiently proven therapies (article R.4127-39 CSP), ”recalls the CNAM.This is precisely the case of hydroxychloroquine and the ivermectin in indications against covid, for which there is no consensus of the scientific community on the effectiveness of these drugs in the COVID.

For the first of these treatments, the question no longer really arises since the government prohibited its out -of -MA issuance in the COVVI, in town and in the hospital.In the case of the ivermectin, the liability of the prescriber could be engaged.

In a decision rendered at the beginning of April, the ANSM refused a request for RTU (recommendation of temporary use) in favor of the ivermectin, believing that the lack of available data "does not allow us to presumea favorable benefit/risk ratio, in curative treatment or prevention ”.The agency also pointed out that the High Council of Public Health had concluded that the use of this molecule against the COVVI-19 is given the absence of the use of this molecule, outside a clinical trial.

In March, the European Medicines Agency had spoken."The evidence currently available is not sufficient to support the use of the ivermectin in the COVVI-19 outside the clinical trials," she said in a press release.She believed that the risk of toxicity of higher doses "necessary to obtain ivermectin concentrations in the effective lungs against the virus" could not be excluded.

In the event of a complaint, the doctor implicated must demonstrate that his prescription is not in contradiction with this data established by scientists.