Health authorities announced new measures on Thursday to limit the risks associated with tramadol and codeine, opioid drugs that continue to be abused in France. In particular, it will be necessary to present the pharmacist with a tamper-proof prescription.
"These are very good drugs for relieving pain, but given the potential risks they present, it is important to reinforce their proper use," Philippe Vella, medical director at the National Agency for the Safety of Medicines (ANSM), told AFP.
Tramadol is the main treatment in the opioid family. These are generally used as painkillers, but have a high risk of addiction with significant health risks.
Codeine is also an opioid medication used to relieve coughs 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 on prescription.
To reduce the risk of abuse, medicines containing tramadol or codeine, alone or in combination with other substances (paracetamol, ibuprofen, etc.) will only be dispensed upon presentation of a secure prescription from December 1, the ANSM announced on Thursday.
This type of prescription must meet criteria to make it tamper-proof: mention of mandatory information pre-printed in blue to identify the prescriber, appearance of a watermark representing a caduceus, presence of micro-letter squares, minimum weight fixed at 77 g/m2, etc.
The dosage, the dose and the duration of the treatment must be written out in full.
Some types of medication 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," Philippe Vella told AFP.
Prescriptions established before December 1 will remain valid until their expiry date.
– Overdoses –
"We must restrict the use of these highly addictive drugs as much as possible," Philippe Besset, president of the FSPF, the main pharmacists' union, told AFP.
This measure is "a step in the right direction" according to him, even if "we are going to use an outdated means of verification since we should already have moved into the new era of digital ordinance, which would avoid any problem of falsification". But "there is a real delay on this subject", he regretted.
Another measure announced on Thursday: the maximum prescription period for codeine will be reduced to 12 weeks from December 1. Beyond that, a new prescription will be necessary.
The drug agency has been trying for years to control the risks surrounding these drugs, which have caused a massive health crisis in the United States. They have been prescribed and consumed in a largely uncontrolled manner, particularly fentanyl.
In France, the situation is not comparable, but many health professionals are concerned about an increase in cases of misuse of opioids.
Since 2017, all medicines containing codeine have been subject to a medical prescription. In 2020, the maximum prescription period for medicines containing tramadol was reduced to 12 weeks.
The ANSM has also asked manufacturers to 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, overdoses or dependence, hence the need for new measures.
The ANSM is now considering how to better inform patients about the risks associated with these drugs. For example, it is considering asking laboratories to put warning notices on boxes containing tramadol or codeine.
Some 10 million French people received at least one prescription for opioid painkillers in 2015, according to the latest report drawn up by the ANSM in 2019.
In 2022, tramadol abuse led to 14 deaths in France, codeine abuse led to 6 deaths the same year.
"Last year, the number of tramadol tablets prescribed decreased by 6% compared to 2022: fewer are being prescribed, we now need to use them better," argued Philippe Vella.
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