From 1is December, medications containing tramadol or codeine must be prescribed using a secure prescription, the Medicines Safety Agency (ANSM) announced Thursday, September 26.
As with tramadol, the maximum prescription duration for codeine cannot exceed 12 weeks. After this period, continued treatment will require a new prescription.
These medications are indicated in the treatment of moderate to severe pain and in the treatment of dry coughs for certain codeine medications.
But tramadol and codeine, belonging to the opioid family, are associated with risks of dependence, overdose, abuse and misuse.
These measures also concern dihydrocodeine, an opioid indicated in the treatment of moderate to severe pain.
Why strengthen regulations?
Although the French situation is incommensurate with the opioid crisis plaguing the United States, the abuse of opioids and their misuse are nevertheless taken very seriously by specialists.
The ANSM has strengthened their regulations several times. Thus, since 2017, all medications containing codeine are subject to a medical prescription.
From April 2020, the maximum prescription duration for medications containing tramadol was reduced to 12 weeks. In addition, manufacturers were asked to manufacture boxes containing fewer tablets, suitable for short-term treatments.
But these measures were not enough. ” THE drug dependence and addictovigilance surveys show the persistence of cases of misuse (abuse, overdoses), dependence and presentation of falsified prescriptions for these drugs”, justifies the ANSM.
What do the surveys say?
According to drug dependence and addictovigilance surveys, for several years, more and more subjects have declared tramadol as 1is product leading to dependence (68 subjects in 2023 versus 4 in 2013).
Codeine comes in fourth position, behind morphine, tramadol, oxycodone and codeine.
In 2022, of the 3,629 prescriptions suspected of falsification, tramadol concerned 17.3% of them, antitussive codeine 15.8%.
“Tramadol alone or in combination with paracetamol is increasing compared to 2022 with 457 mentions”, notes the investigation into suspicious prescriptions from addictovigilance.fr.
What is a secure prescription?
A secure prescription must be tamper-proof. It concerns medications with a high risk of dependence or abuse.
These are narcotics or medications subject to strict regulation.
Secure prescription notebooks must be ordered from Afnor certified printers to meet the requirements of the Health Code:
- natural white watermarked paper without optical brightener (1 complete and 2 incomplete caduceus);
- pre-printed information in blue to identify the prescribing professional;
- a security square made up of micro-letters;
- minimum weight of 77 g/m2;
- presence of square in micro-letters.
The prescriber must write in full the dosage, dosage, and duration of treatment.
What additional recommendations?
The ANSM asks prescribers:
- to prescribe these medications for the shortest possible periods (3 to 14 days for acute pain, treatment reassessed every three months for chronic pain);
- to gradually stop treatments in order to avoid a withdrawal syndrome;
- to use opioids with caution in patients with epilepsy.
To patients, the ANSM asks:
- to respect the dosage and the interval between doses;
- not to suddenly stop treatment;
- never offer the treatment to another person;
- to contact emergency services if a person has ingested tramadol or codeine that was not intended for them
