Rivotril and Ehpad

Tribune: While the tension on hospital services is increasing, the number of Covid-19 cases in nursing homes remains worrying. In its decree of October 16 establishing the curfew, the government reintroduced the expansion of the use of Rivotril in nursing homes.

“Notwithstanding Article L. 5121-12-1 of the Public Health Code, the pharmaceutical specialty Rivotril® in injectable form can be dispensed with by community pharmacies for the purpose of taking in charge of patients affected or likely to be affected by the SARS-CoV-2 virus whose clinical condition warrants it upon presentation of a medical prescription bearing the words “Prescription Outside Marketing Authorization in the context of Covid-19” ”, indicates this decree signed by Jean Castex, Olivier Véran, Gérald Darmanin and Sébastien Lecornu.

This device, published in the Official Journal on March 29, 2020, which was to remain an exception, was first extended in May (Decree No. 2020-663 of May 31, 2020) until July 10, has therefore reappeared in the decree of October 16 establishing the curfew.

When it was introduced, the decree stipulated that Rivotril (clonazepam) in injectable form could be “dispensed, until April 15, 2020, by dispensing pharmacies for the care of patients with or likely to be affected by the SARS-CoV-2 virus, the clinical condition of which justifies it on presentation of a medical prescription bearing the words “Prescription Outside Marketing Authorization in the context of Covid-19” ”. He specified that in this prescription without marketing authorization (AMM), the doctor must “comply with exceptional and transient protocols relating, on the one hand, to the management of dyspnea and, on the other hand, to the palliative management of respiratory distress, established by the French Society for Support and Palliative Care (SFAP) ”.

This medication belongs to the benzodiazepine family, it has an anxiolytic (calming), sedative (sleep, coma) and anti-convulsant (against epilepsy: its indication for Marketing Authorization). It is contraindicated in severe respiratory failure. What is clearly specified among the contraindications listed in the Vidal “This medication should never be used in the following situations … severe respiratory failure”

The exceptional authorization to prescribe Rivotril® in an outpatient injectable form and off-label very quickly aroused reactions of mistrust, as Rivotril could become the agent of euthanasia which does not speak its name. Affirming that this fear was unfounded; Professor Frédéric Guirimand and Dr Claire Fourcade (National Platform for the End of Life) have published a duly argued update, which can be downloaded. To avoid the feeling of suffocation, sedation (decrease in consciousness) may be necessary and sometimes urgent because the degradation to asphyxia can sometimes be rapid

Therapeutic proposals graded according to the seriousness of the situation and indicating under what circumstances and how to handle these drugs were made by the SFAP (French company for support and palliative care). It is about helping teams to anticipate these situations and be able to react quickly. These clarifications were not enough to defuse the doubt.

This decree casts unbearable doubt on the decisions of doctors who could be suspected of injecting Rivotril to free beds in hospitals or in EHPADS. Or that a doctor alone or an isolated person (I dare not imagine it) makes the decision to inject Rivotril in an EHPAD or related, to end the life of a patient (Atlantico April 6, 2020)

The reactivation of this decree formalizes and perpetuates the state of shortage of equipment, resuscitation beds, respirators … in which France is located, which has not been able to take advantage of the past 6 months to overcome these deficiencies

What is curious is that the Afssaps had decided to modify the conditions of prescription and delivery of Rivotril® (clonazepam) because of its broad prescription outside the indications of its Marketing Authorization, in particular in neurogenic pain at dose spun. In order to promote the correct use of Rivotril® and limit its diversion, this medication indicated in the treatment of epilepsy could no longer be prescribed except on a secure prescription and, from January 2, 2012, the prescription could no longer be prescribed. initiated only by a neurologist or pediatrician. At the same time, as part of the Risk Management Plan (RMP) set up to limit the diversion and the risks of chemical submission linked to clonazepam, the Roche laboratory added a blue dye to the Rivotril® drinkable solution. 2.5 mg / ml. The other ingredients of this medicine are the same. It is above all that Rivotril was one of the drugs most used in cases of “chemical submission” using products administered without the knowledge of the victim for criminal or tortious purposes (theft, violence, rape). ‘where its name of “date rape drug”.

It should therefore be understood that it is for lack of places in hospitals, in intensive care, that the elderly are refused, that they are only entitled to support, sedation (decrease in consciousness) to avoid feeling of suffocation which may occur. Is it worthy of a civilized country?

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