tramadol,-codeine-:-why-france-is-delaying-its-new-measures-against-opioids

Tramadol, codeine: why France is delaying its new measures against opioids

December 15, 2024

For years, the French National Agency for the Safety of Medicines (ANSM) has been concerned about the increasing consumption of opioids, a phenomenon that affects millions of French people. These treatments are painkillers with a different and potentially stronger action than the classics such as paracetamol or aspirin. But they present risks of dependence and overdose, which can sometimes be fatal.

The ANSM regularly expresses its concern and, over the years, has taken increasingly restrictive measures to reduce their consumption, with the catastrophic opioid crisis in the United States as a counter-model, which has caused hundreds of thousands of deaths since the 1990s.

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According to the ANSM, the use of tramadol increased by 68% between 2006 and 2017

The latest measures were to concern two emblematic opioids: codeine and tramadol, the consumption of which accelerated from the end of the 2000s. According to one of the latest ANSM reference studies, the use of tramadol increased by 68% between 2006 and 2017.

The new measures, including the introduction of tamper-proof prescriptions, were due to come into force at the beginning of December. But at the last minute, the ANSM discreetly postponed them: they are now scheduled for the beginning of March. Why delay? The agency explains its choice by the need to "facilitate the transition to these new measures for health professionals and ensure patients have access to their treatments."

Because many professionals have judged these measures to be hasty. For some, such as pharmacists, it is a matter of practical concerns: the time needed, for example, to acquire the tools required to read the digital version of the unforgeable prescriptions. But for others, the criticism is more substantive. This is the case of the French Society for the Study and Treatment of Pain (SEFTD), which, at the end of November, expressed its fear that these measures would lead to a "opiophobia" that would be harmful to patients.

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You can also find out more about "delicate balance"

This society – which brings together doctors, pharmacists and nurses – warned "on the risks associated with potential interruptions in analgesic prescriptions, the effects of which can be disastrous for pain management". Admitting the risks associated with opioids, she called for finding "a delicate balance", judging the parallels with the American situation to be excessive.

In 2022, France recorded 14 deaths linked to tramadol and six to codeine, dramatic situations but not comparable to the United States, where opioid consumption has long been markedly lacking in rules. Does the temporary postponement of the measures satisfy the SFETD, which was calling for a "moratorium"? Questioned by AFP, the company did not respond, but pain specialists individually criticize the principle of these restrictions, whether delayed or not.

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"The establishment of a secure order seems to me to be disproportionate in relation to the current situation in France", judges rheumatologist Florian Bailly to AFP. "There are certainly some cases of abuse of tramadol or codeine, but the data (...) suggest that their number is limited." The debate remains open, however, because other experts view the firmness of the health authorities favorably. They are less found among pain specialists than in the world of addictology or pharmacovigilance, a discipline that monitors the risks associated with medications.

"I can understand the reluctance that there may be to implement secure prescriptions, but past experiences have so far given rise to very positive results," pharmacologist Antoine Pariente told AFP. Secure prescriptions have, for example, been used for pregabalin, a painkiller and anti-epileptic, without causing a "catastrophe in patient care," he emphasizes, recognizing nevertheless that tramadol and codeine are much more widely used.

The expert is, in any case, not convinced by the fact of minimizing the French situation in relation to the United States. "The argument is strange", Mr. Pariente believes. "We should not wait for a problem to become bigger before taking action."

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