The measure will come into force on December 1, 2024, announces the Medicines Agency in a press release.
The risks associated with taking these pain medications continue to grow and the National Medicines Agency (ANSM) recognizes in a press release dated September 26 that the measures taken so far “did not sufficiently reduce misuse”.
They are effective in reducing pain, no doubt about it, but taking them is also associated with risks. “significant dependence, abuse and overdose”. These harms can occur quickly in any patient. Also the ANSM has decided to further restrict the use of these opioids. It had already imposed their prescription by prescription, the reduction of their prescription duration and even asked the manufacturers who market them to put on the market boxes containing fewer tablets.
To further secure their use and reduce the risks of these medications, the ANSM announces that they will have to be prescribed on a “secure” prescription from December 1, 2024. The so-called “secure” prescriptions were created by the decree n°99-249 of March 31, 1999 and meet “technical specifications” that are not found in traditional ordinances. Concretely, a secure prescription cannot be blank. Its pre-printing indicates the nominative identification of the prescribing doctor (with a means of contacting him) and the identity of the recipient of the prescription (who is not the patient but the establishment dispensing the medicine) with his address and their membership in a health profession. The doctor must indicate in full the number of therapeutic units per dose, the number of doses and the dosage. This type of prescription reduces the risk of falsification.
The opioid analgesics targeted by these new decisions are Tramadol and codeine. “We are also aligning the maximum prescription duration of codeine with that of tramadol: these medications cannot be prescribed for more than three months (12 weeks) without requiring a new secure prescription” announces the ANSM. These measures also concern dihydrocodeine. As a reminder, tramadol and codeine can be present in medications alone or in combination with other substances, such as paracetamol or ibuprofen. Medicines containing tramadol or codeine are indicated for the treatment of moderate to severe pain and some medicines containing codeine are indicated for the treatment of bothersome dry coughs. Prescriptions established before December 1 will remain valid until their end.
When using medications containing tramadol or codeine, the dosage, duration of treatment and interval between doses must be strictly followed. Do not stop your treatment suddenly to avoid side effects related to withdrawal. Never offer your treatment to anyone you know, even if they seem to have symptoms similar to yours. If a person (child or adult) has ingested tramadol or codeine that was not intended for them, immediately contact a poison control center or emergency service: 15 (Samu), 18 (fire brigade) or 112. If you experience side effects related to taking these treatments, consult your doctor and report them on the reporting portal.
