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 December 1, a announced the ANSM this Thursday.
“In 2022, of around 2,600 falsified prescriptions, 457 concerned tramadol. »
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 micro-letters, weight minimum 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,” specified Philippe Vella. Prescriptions established before December 1 will remain valid until their end.
Overdoses and addiction
“We must restrict the use of these powerfully addictive medications as much as possible,” added 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 This measure goes “in the right direction” according to him, even if “we are going to use an outdated means of verification since we should already have moved into the new era of digital ordering, which would avoid any problem of falsification”.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 Thursday: the maximum prescription duration of codeine will be reduced to 12 weeks from December 1. Beyond that, a new ordinance will be necessary. The drug agency has already been trying for years to control the risks surrounding these drugs which have notably 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. 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. In 2022, tramadol abuse led to 14 deaths in France, codeine abuse led to 6 deaths the same year.
