For years, the National Medicines Safety Agency (ANSM) has been concerned about the increasing consumption of opioids, a phenomenon that concerns millions of French people.
These treatments are painkillers with a different and, potentially, stronger action than the great classics such as paracetamol or aspirin. But they present risks of dependence and overdose, sometimes fatal.
The ANSM regularly expresses its concern and, over the years, has taken increasingly restrictive measures to reduce their consumption, with the counter-model of the catastrophic opioid crisis in the United States, which has caused hundreds of thousands deaths since the 1990s.
The latest measures to date 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 tramadol increased by 68% between 2006 and 2017.
The new measures, including the implementation of tamper-proof orders, were to come into force at the beginning of December. But, at the last moment, the ANSM discreetly postponed them: they are now scheduled for the beginning of March.
Why procrastinate? The agency explains its choice by the need to “facilitate the transition to these new measures for healthcare professionals and ensure patients have access to their treatments“.
Because many professionals considered these measures hasty. For some, like pharmacists, these are practical concerns: the time required, for example, to acquire the tools required to read the digital version of tamper-proof 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, said it feared that these measures would lead to “opiophobia” which would be harmful to patients.
“Delicate balance”
This company – which brings together doctors, pharmacists and nurses – alerted “on the risks associated with potential interruptions of analgesic prescriptions, the effects of which can be disastrous for pain management“.
Admitting the risks linked to opioids, she called for “a delicate balance” to be found, deeming the parallels with the American situation excessive.
In 2022, France recorded 14 deaths linked to tramadol and six to codeine, dramatic situations but incommensurate with the United States, where the consumption of opioids has long experienced a glaring absence of rules.
Does the temporary postponement of the measures satisfy the SFETD, which requested a “moratorium“? Questioned by AFP, the company did not respond but pain specialists individually criticize the principle of these restrictions, delayed or not.
“The implementation of a secure order seems disproportionate to me compared to the current situation in France“, judges rheumatologist Florian Bailly with AFP. “There are certainly some cases of abuse of tramadol or codeine, but the data (…) suggest that their number is limited“.
The debate, however, remains open because other experts welcome the firmness of the health authorities. They are found less among pain specialists than in the world of addictology or pharmacovigilance, a discipline which monitors the risks associated with medications.
“I can understand the reluctance that there may be regarding the implementation of secure prescriptions, but past experiences have so far given rise to very positive results.“, estimates pharmacologist Antoine Pariente to AFP.
Secure prescriptions have, for example, been used for pregabalin, a painkiller and anti-epileptic drug, without causing “disaster in patient care“, he emphasizes, nevertheless recognizing that tramadol and codeine are used much more.
The expert is, in any case, not convinced by minimizing the French situation in relation to the United States.
“The argument is strange“, believes Mr. Pariente. “We shouldn’t wait for a problem to become bigger before we act on it.”.
