postponement of secure prescriptions to March 1, 2025

The National Agency for the Safety of Medicines and Health Products (ANSM) announced the postponement until March 1, 2025 of the new rules governing the prescription of tramadol, codeine and dihydrocodeine. These measures, initially planned for December 1, 2024, include the obligation of a secure prescription and a limitation of the prescription period to 12 weeks. If their objective is to reduce abuse and misuse, several voices, including the French Society for the Study and Treatment of Pain (SFETD), express reservations about their implementation.

Measures to better regulate the use of weak opioids

One objective: to limit the risks of dependence and misuse
Tramadol and codeine, commonly prescribed to relieve moderate to severe pain, are associated with significant risks of misuse, dependence and overdose. According to data from the French Addictovigilance Network, the percentage of suspicious prescriptions for tramadol increased from 6.9% in 2013 to 17% in 2022. Deaths linked to tramadol represented 35% of cases of toxic deaths from analgesics in 2022, or 48 deaths out of 135. These figures underline the urgency of strengthening the rules surrounding their prescription.

The new detailed obligations
From March 1, 2025:

  • Medicines containing tramadol or codeine must be prescribed using a secure prescription. These prescriptions must state in full the dosage, dosage and duration of treatment.
  • The maximum prescription duration will be reduced to three months for codeine and dihydrocodeine, aligning with the rules already in force for tramadol.
  • Any extension of treatment will require a new prescription.

Professionals’ concerns about rushed implementation

The SFETD, through its president, Professor Valéria Martinez, warned of the possible consequences of rapid implementation. According to the association’s press release, several major obstacles make the immediate application of the new measures difficult:

  • THE secure prescriptionsalthough necessary, are not available in sufficient quantities.
  • THE prescription softwarein their current state, do not allow the new requirements to be integrated.
  • THE healthcare professionals have not received adequate training to comply with the new rules.

These shortcomings could lead to interruptions in patient care, with serious repercussions, such as an increase in emergencies for poorly controlled pain or medical wandering, with patients seeking solutions outside secure circuits.

The SFETD highlights a paradox: although these measures aim to secure prescriptions, the increase in the number of paper prescriptions could increase the risk of theft or falsification. Dr Marguerite d’Ussel, deputy general secretary of the SFETD, notes that “theElectronic prescriptions could have offered real security, but their implementation is still too limited“.

Inappropriate comparisons and a necessary balanced vision

A different context of the opioid crisis in the United States

The SFETD insists on the need to adapt public policies to the French context. Unlike the United States, where the opioid crisis is marked by massive misuse of strong opioids (such as oxycodone), is mainly confronted with abuse of weak opioids. With a rate of 0.2 deaths per 100,000 inhabitants linked to opioids in 2022, the French situation is much less critical than that of the United States (20 deaths per 100,000 inhabitants).

We need to be as concerned about the risks of over-prescribing as we are of under-prescribing when opioids are necessary.“, underlines Professor Valéria Martinez, recalling the importance of avoiding “opiophobia” which could deprive patients of essential treatments.

Recommendations for successful application of measures

Better train health professionals

The SFETD recommends strengthening the initial and continuing training of prescribers on pain management and the use of opioids. Educating patients about risks and best practices is also considered crucial.

Integrate digital solutions

The integration of secure electronic prescriptions, already promised within the framework of Ségur de la santé, is seen as a long-term solution. These tools would limit the risks of falsification while facilitating the work of health professionals.

Disseminate existing recommendations

The recommendations published by the HAS in 2022, aimed at promoting the proper use of opioids, have not yet had time to produce their effects. Better dissemination and application of these guides is essential to reduce abuse without restricting patients’ access to necessary treatments.

A postponement, but persistent uncertainties

The postponement until March 1, 2025 allows valuable time to adapt to the new rules. However, logistical and organizational challenges remain numerous. The balance to be found between reducing abuse and preserving access to treatment is at the heart of concerns.

As Professor Eric Serra, vice-president of the SFETD, summarizes: “The scandal with opioids is not prescribing them, it is not prescribing them.” This declaration illustrates the need for balanced policies, respectful of the needs of patients and the realities of health professionals.

See the SFETD press release

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