What medications?
The tramadol and the codeine will be subject to new measures introduced by the French health authorities.
These two medicines are dispensed only on prescription.
What risks?
Tramadol is the main treatment in the family of opioids. These are generally used as painkillers, but have a high risk of addiction.
Codeine is also an opioid medication used to relieve cough and mild or moderate painwhich can be addictive when used in high doses and over a long period of time.
In 2022, tramadol abuse led to 14 deaths in France, and 6 for codeine.
Some 10 million French people received at least one prescription for opioid painkillers in 2015, according to the latest inventory drawn up by the National Agency for the Safety of Medicines and Health Products (ANSM) in 2019.
What measures?
Medicines containing tramadol or codeine, alone or in combination with other substances (paracetamol, ibuprofen, etc.) will be dispensed only upon presentation of a secure order from December 1stannounced the ANSM this Thursday.
This type of order must meet criteria aimed at 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 squares in micro-letters, minimum weight set at 77 g/m2… The dosage, the dosage and duration of treatment must be written in full.
Prescriptions established before December 1 will remain valid until their end.
Certain types of medications are already subject to this type of prescription: opioids (such as morphine), psychotropic drugs (certain antidepressants and antipsychotics) or narcotics.
Another measure announced Thursday: the maximum prescription duration of codeine will be reduced to 12 weeks starting December 1st. Beyond that, a new ordinance will be necessary.
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.
For what?
The medicines 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 there in a largely uncontrolled manner, particularly fentanyl.
In France, the situation is out of all proportion, but many health professionals are concerned about a increase in cases of misuse opioids.
“These are very good medications to relieve pain but given the potential risks they present, it is important to reinforce their proper use”summarized Philippe Vella, medical director at ANSM, to AFP.
“In 2022, out of approximately 2,600 falsified prescriptions457 concerned tramadol, 416 codeine for its antitussive specialties and 293 for indications against pain.he clarified.
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 surveys have shown the persistence of cases of abuse, overdose or dependencehence the need for new measures.
“We must restrict the use of these powerfully addictive drugs“added Philippe Besset, president of the FSPF, the main pharmacists’ union, to AFP.
This measure will “in a good way” 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 prescriptions, which would avoid any problem of falsification”. More “there is a real delay on this subject”he regretted.
