From April 15, tramadol, the most consumed opioid in France, will no longer be prescribed for one year but for three months.
“We have the backdrop of the opioid crisis in the United States”. Fearing that a phenomenon which killed 70,000 across the Atlantic might occur in France, the National Medicines Safety Agency (ANSM) announced Wednesday January 15 that it was going to modify the duration of prescription of the tramadol. From April 15, 2020, it will go from one year to three months. The painkiller, derived from opium, is the most prescribed opioid in France (12 million boxes sold each year) and has already been monitored by health authorities since 2014.
“Various surveillance reports have drawn our attention in recent months to a number of misuses, abuses and addictions involving tramadol. Addiction that can develop even over a short period of time and respecting the doses”, explains Nathalie Richard, deputy director of analgesic and narcotic drugs at theANSMto justify this decision.
This phenomenon is all the more worrying since overdoses and addictions do not only concern drug users but also people suffering from chronic pain. Thus, following a car accident or a painful operation, a patient may be prescribed tramadol and become dependent.
Limit misuse
The proof is: it is the opioid most implicated in deaths linked to analgesics. “A specific investigation into deaths with analgesics in 2016 revealed that out of 84 deaths, 37 concerned patients who consumed tramadol”, specifies Nathalie Richard. What’s more, this drug is the second most frequently found analgesic on falsified prescriptions presented in pharmacies, behind codeine.
Despite everything, the ANSM preferred not to withdraw it from sale and not to limit its access. “Tramadol maintains a favorable risk/benefit balance. There should therefore be no transfer to other analgesics”, explains Nathalie Richard.
Thus, today, the goal of health authorities is to limit misuse. “The doctor can reassess the interest of the treatment for the patient every three months [et non plus une fois pas an] but also carry out a good tolerance assessment to be sure that there is no risk of abuse”. Unfortunately, seeing the effect of the drug diminish as the body gets used to it, some patients increase the doses on their own initiative.
Do not stop your treatment along the way
Health professionals must therefore further inform patients of the potential side effects (constipation, vomiting, headaches and convulsions and possibly hypoglycaemia, etc.) and risks of addiction.
“Doctors have a role to play in identifying patients who are beginning to show signs of addiction, in directing them to structures that treat addiction,” insists Nathalie Richard. As before, the patient will have to buy the drug every month from the pharmacy.
But if you have been prescribed tramadol, do not stop your treatment, assures the ANSM. “The patient must respect the prescribed doses, not increase the dosage on his own, respect the duration of the treatment, and not stop his treatment suddenly, but gradually. Because as with all opioids, the patient may experience a withdrawal syndrome. Finally, if the pain is not relieved, he must go see his doctor”, concludes Nathalie Richard.
An official roadmap to prevent and act on overdoses
Regarding other opioids, the prescription for fentanyl, morphine and oxycodone, three opioids classified as narcotics, is only valid for one month. As for codeine, since 2017, all medicines containing it must now be delivered on doctor’s prescription.
“Problematic opioid use spans a diversity of people and situations, often complicated by associated illnesses and vulnerabilities. People suffering from chronic or acute pain and people dependent on opioids must be able to benefit from comprehensive care adapted to their situation”, wrote the Ministry of Health in July in a roadmap to prevent and act. against overdoses. “Developed in conjunction with the actors concerned, institutions, health professionals and civil society, this roadmap has 5 objectives: improve professional practices, ensure wide distribution of ready-to-use naloxone (antidote, editor’s note), involve users and their families, network all players at the territorial level and promote coordinated actions proximity, strengthen the vigilance, alert and response system”, it is specified.
If France is still far from the American epidemic, the number of hospitalizations in France linked to an overdose of opioids increased by 167% between 2000 and 2017 and the number of deaths between 2000 and 2015 by 146%. . What deeply worry the experts.
.
