New measures to try to reduce opioid abuse in France

French health authorities have announced new measures to limit the risks linked to Tramadol and codeine, painkillers with a high risk of dependence which continue to be abused in the country. In particular, you will need to present a tamper-proof prescription to the pharmacist.

The National Medicines Safety Agency (ANSM) has already been trying for years to control the risks around these drugs, opioids which have caused a massive health crisis in the United States. They were prescribed and consumed in a largely uncontrolled manner, particularly Fentanyl.

In France, the situation is out of proportion, but many health professionals are concerned about an increase in cases of misuse of opioids.

Some 10 million French people received at least one prescription for opioid analgesics in 2015, according to an inventory drawn up by the ANSM in 2019. In 2022, the abuse of Tramadol led to 14 deaths in France, the abuse codeine caused six deaths in the same year.

“These are very good medications for relieving pain, but given the potential risks they present, it is important to reinforce their proper use,” summarizes Philippe Vella, medical director at the ANSM.

Tramadol is the main treatment in the opioid family. These are typically used as painkillers, but carry a high risk of addiction with significant health risks.

Codeine is also an opioid medication used to relieve cough and mild to moderate pain, which can be addictive when used in high doses and over a long period of time.

These medications are available only by prescription.

To reduce the risk of abuse, medications containing Tramadol or codeine, alone or in combination with other substances (paracetamol, ibuprofen, etc.), will be dispensed only on presentation of a secure prescription from 1 December, announced the ANSM.

This type of prescription must meet criteria aimed at making it tamper-proof: mention of mandatory information pre-printed in blue to identify the prescriber, appearance of a watermark representing a caduceus, presence of squares in microletters, minimum weight set at 77 g/m2…

The dosage, posology and duration of treatment must be written in full.

Certain types of medications are already subject to this type of prescription: opioids (such as morphine), psychotropic drugs (certain antidepressants and antipsychotics) or narcotics.

“In 2022, out of approximately 2,600 falsified prescriptions, 457 concerned Tramadol, 416 codeine for its antitussive specialties and 293 for indications against pain,” specifies Philippe Vella.

Prescriptions established before December 1 will remain valid until their end.

Surdosages

“We must restrict the use of these powerfully addictive medications as much as possible,” adds Philippe Besset, president of the FSPF, the main pharmacists’ union.

This measure goes “in the right direction” according to him, even if “we are going to use an outdated means of verification since we should have already moved into the new era of digital ordering, which would avoid any problem of falsification”. But “there is a real delay on this subject”, he regretted.

Another measure announced: the maximum prescription duration of codeine will be reduced to 12 weeks from December 1. Beyond that, a new ordinance will be necessary.

Since 2017, all medications containing codeine are subject to a medical prescription. In 2020, the maximum prescription duration for medicines containing Tramadol was reduced to 12 weeks.

The ANSM also asked manufacturers to place on the market boxes of Tramadol containing fewer tablets, suitable for short-term treatments.

Despite these efforts, various investigations have shown the persistence of cases of abuse, overdose or dependence, hence the need for new measures.

The ANSM is now considering how to better inform patients of the risks associated with these medications. For example, it plans to ask laboratories to put alert notices on boxes containing Tramadol or codeine.

“Last year, the number of Tramadol tablets prescribed decreased by 6% compared to 2022: we prescribe fewer, we must now use them better,” argued Philippe Vella.

Isabelle TOURNÉ/AFP