It is a discreet, but important measure which has just come into force in the French health system. Drugs containing tramadol, codeine, dihydrocodeine, or any other astounding substance (morphine for example) can now be issued in pharmacy only on presentation of a very specific secure prescription. This regulatory development, initially scheduled for December 2024 and then postponed at the beginning of this year, aims to fight against the abuse of this type of drug with high dependence. For the millions of French people concerned, we will have to be vigilant.
New regulations for opioid analgesics
The drugs concerned by this new text, usually used to treat moderate to severe pain, can be delivered in pharmacies only on presentation of a secure prescription. This change concerns all forms of these substances, whether prescribed alone or in association with other active ingredients such as paracetamol or ibuprofen. The regulations also apply to drugs for veterinary use.
This is a significant development for patients under chronic treatment, but also for prescribers who will have to adapt their practices. On these new secure prescriptions, the doctor must register in all letters (and not in figures) the dosage of the drug, the exact dosage and the precise duration of the treatment. This obligation aims to limit the risks of falsification of the most at risk.
In parallel, the maximum duration of validity of a codeine and dihydrocodeine prescription is now aligned with that of tramadol, 12 weeks. Beyond this period, a new medical consultation and a new prescription will be necessary to continue treatment, even for long-term treatment patients.
The National Agency for Drug Safety and Health Products (ANSM), however, intends to grant patients and caregivers a transitional period. The edited orders Until next March 31as well as their renewal, can be accepted by pharmacies, even without meeting the security criteria.
What is a secure prescription and how to recognize it?
The secure prescription, also called “protected order“, Can arise in two forms: paper or digital. To be valid, it must meet strict criteria defined by the French Normalization Association (AFNOR) which theoretically makes it infalcilable.
In its paper version, a secure prescription has several distinctive characteristics: compulsory information pre-printed in blue allowing to identify the prescribing health professional, a watermark representing a visible caduceus by transparency, the absence of optical azurant in the paper, and a minimum grammage of 77 g/m². Manufactured by printers certified by AFNOR, which must Respect rigorous specifications, These prescriptions will be sold to block doctors of 50 or 100 copies and delivered directly to the medical office by secure transport. To order it, the health professional must have an RPPS number (shared directory of health professionals) and an AM number (health insurance).
Regarding digital prescriptions, the doctor writes the prescription in his business software, which generates a unique identifier associated with a QR code. The pharmacist can then scan this QR code to access the prescription data stored in a secure database hosted in France.
What changes for patients?
Patients treated with Tramadol, Codeine or Dihydrocodeine will have to ensure that their doctor transmits them a secure prescription (paper or digital) for these drugs. Without this type of prescription, the release in pharmacy will not be possible. Do not expect to get out of it with a scan of the paper version.
Another notable change for patients, they will now have to be followed more regularly for a long -term condition, at least every 12 weeks to renew their prescription. As we said, the orders established between March 1 and 31225, however, remain valid (in theory). Same thing for those prior to March 1, 2025. A means of ensuring a gentle transitionavoiding treatment breaks. The fact remains that the transition period is not respected by all pharmacies. From the beginning of the month, some refused to issue us the drugs on the list.
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