The prescription of tramadol and codeine by secure prescription is postponed until March 1, 2025

In order to better regulate the delivery of medicines containing tramadol and codeinethe National Agency for the Safety of Medicines and Health Products (ANSM) has decided to make the prescription of these two opioids via a secure prescription.

The stated objective: to better understand exposure to danger when using tramadol and codeine.

The measure was to come into force from 1^is December 2024, it will finally be postponed to 1^is mars 2025.

Preventing the risks of addiction and trafficking

In a decision rendered on September 24, 2024, the National Agency for the Safety of Medicines and Health Products (ANSM) recommended secure the use of codeine and tramadol, to prevent the risk of dependence, misuse and prescription falsification linked to these opioids.

She announced the following measures:

• Medicines containing tramadol, codeine and dihydrocodeine, alone or in combination with other substances (paracetamol, ibuprofen, etc.), will be dispensed only on presentation of a secure prescription. The prescriber must have written in full: the dosage, dosage and duration of treatment.
• Limit the maximum prescription duration of codeine to 12 weeks (3 months), as is the case for tramadol. Beyond this period, continued treatment with codeine will require a new prescription.

These two provisions, which were to come into force from 1^is December 2024, have been postponed to 1^is mars 2025.

What is a secure prescription?

A secure prescription, also called a “protected prescription”, must meet the criteria intended to make it tamper-proof. These criteria are defined by the French Standardization Association (AFNOR) :

• On the prescription, mention of mandatory information pre-printed in blue to identify the prescribing healthcare professional, even when he or she belongs to a multidisciplinary structure (a secure prescription cannot be blank);
• Presence of systems to combat fraud, counterfeiting, falsification and theft;
• Recognition immediately possible by the pharmacist, without having to have specific means;
• Appearance of a watermark representing a caduceus;
• Absence of optical brightener on the paper;
• Minimum weight set at 77 g/m2.

In order to reduce the risk of misuse, it is planned that the prescription of these two opioids will be done via a tamper-proof prescription.