Tramadol and codeine, opioid drugs that continue to be abused in France, will have to be prescribed on a so-called "secure" prescription, i.e. one that cannot be forged, from December 1, the National Agency for the Safety of Medicines (ANSM) announced on Thursday.
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 medicines can only be dispensed upon presentation of a prescription.
Despite several measures already taken to reduce the risks of misuse, various surveys have shown the persistence of cases of abuse, overdoses, dependence and presentation of falsified prescriptions for these treatments.
In order to further reduce the risks, the ANSM announces that from December 1, 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.
This type of prescription must meet criteria to make it tamper-proof: mention of mandatory information pre-printed in blue to identify the prescribing healthcare professional, appearance of a watermark representing a caduceus, presence of micro-letter squares to make tampering difficult, minimum weight fixed at 77 g/m2, etc.
The dosage, the dose and the duration of the treatment must be written out in full.
Another measure announced on Thursday: as with tramadol, the maximum prescription period for codeine will be reduced to 12 weeks from December 1. Beyond that, continuing treatment with codeine will require a new prescription.
These two measures also concern dihydrocodeine, an analgesic used to relieve moderate to severe pain.
Opioids, prescribed and consumed in a largely uncontrolled manner in the United States, have caused a massive health crisis in recent decades, particularly with fentanyl.
In France, the situation is not comparable, but many health professionals are concerned about an increase in cases of misuse of opioids such as tramadol, particularly used as a sedative.