Launch of ‘secure medical prescriptions’ in France for certain painkillers - what are new rules?

Stricter rules are being put in place to fight addiction and falsified prescriptions

The rules were originally set to come into effect in December 2024
Published

Certain medicines in France will face stricter rules surrounding their prescription from March 1 in a bid to combat addiction and fraud.

Medicines that include tramadol, codeine or dihydrocodeine which are usually prescribed as painkillers, will require ‘secure prescriptions’ from date onwards.

The prescriptions will include an anti-fraud barcode and additional information. 

In addition, there will be a 12-week limit on prescriptions of drugs including codeine or dihydrocodeine. Such rules have been in place for tramadol since 2020.

These changes were originally set to come into effect from December 1, 2024, but were delayed to give pharmacies more time to prepare for the changes. 

The rules have been championed by France’s medicine watchdog, the Agence nationale de sécurité du médicament et des produits de Santé (ANSM).

Read more: New date set for stricter painkiller prescription rules in France

Prescriptions for other medicines will not be impacted by the changes. 

More than 1,000 prescriptions for the affected drugs were falsified in 2022 – over half of all falsified prescriptions in France. 

The painkillers can become addictive due to their potency. 

Deaths resulting from patients taking tramadol led to restrictions on the number of tablets included in a box.

Read more: Tramadol: fewer pills in boxes in France in bid to reduce addiction

What do these prescriptions look like? 

Secure prescriptions have to meet several criteria, as pointed out by health search tool Doctolib. 

They must: 

  • Contain compulsory information pre-printed in blue enabling the prescribing healthcare professional to be identified, even when he or she belongs to a multidisciplinary structure. This means a secure prescription cannot be blank

  • Leave no space under the prescriber’s signature, and always be signed by the prescriber

  • Include systems to combat fraud, counterfeiting, falsification and theft including an anti-fraud barcode

  • Have a watermark representing a caduceus

  • Not use optical brightener on the paper

  • Have a minimum paper weight of 77 g/m2

The printing companies used to produce these prescriptions’ labels must be approved by the Association Française de Normalisation (AFNOR) body. 

If the prescription is lost, stolen, or falsified, it must immediately be reported to the police by the doctor prescribing the medicine, as article R.5132-4 of France’s Health Code states. 

If you as a recipient lose your prescription, you should immediately contact the doctor who prescribed it to you. 

Advice from the ANSM for patients taking any of the affected medicine includes: 

  • Following the dosage, duration of treatment and interval between doses;

  • Not stopping your treatment abruptly to avoid the side effects associated with withdrawal – your doctor or pharmacist will tell you how to stop gradually

  • Never offering your treatment to someone you know, even if they seem to have similar symptoms to you

  • If someone (child or adult) has ingested tramadol or codeine that was not intended for them, immediately contact a poison control centre or an emergency service

  • For those at risk of overdose who have a naloxone kit (opioid antidote): if the person is drowsy, call the emergency services, administer naloxone and keep them awake until the emergency services arrive

If experiencing any adverse effects associated with these treatments, you should consult your GP immediately. 

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