Tramadol is the main treatment in the opioid family. These are generally used as painkillers, but have a high risk of addiction with significant health risks. Codeine is also an opioid medication used to relieve coughs and mild to moderate pain, which can be addictive when used in high doses and over a long period of time.
Overdoses, addiction and… presentation of falsified prescriptions
These drugs can only be dispensed upon presentation of a prescription. Despite several measures already taken to reduce the risks of misuse, various investigations have shown the persistence of cases of abuse, overdoses, dependence and presentation of falsified prescriptions for these treatments. "In 2022, out of approximately 2,600 falsified prescriptions, 457 concerned tramadol, 416 codeine for its antitussive specialties and 293 for indications against pain", Philippe Vella, medical director at the National Agency for the Safety of Medicines (ANSM), told AFP.
In order to further reduce the risks, the ANSM announces that from December 1, medicines containing tramadol or of the codeine, alone or in combination with other substances (paracetamol, ibuprofen, etc.) will only be dispensed upon presentation of a secure prescription.
This type of prescription must meet criteria to make it tamper-proof: mention of mandatory information pre-printed in blue to identify the prescribing healthcare professional, appearance of a watermark representing a caduceus, presence of micro-letter squares to make falsification difficult, minimum weight fixed at 77 g/m2, etc. The dosage, the dose and the duration of the treatment must be written in full.
Some types of medication are already subject to this type of prescription: Opioids (such as morphine), psychotropic drugs (certain antidepressants and antipsychotics) or narcotics.
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Maximum prescription duration of codeine reduced to 12 weeks
Another measure announced on September 26: as for tramadol, the maximum prescription period for codeine will be reduced to 12 weeks from December 1. Beyond this, continuing treatment with codeine will require a new prescription.
These two measures also concern dihydrocodeine, an analgesic used to relieve moderate to severe pain. Opioids, prescribed and consumed in a largely uncontrolled manner in the United States, have caused a massive health crisis in recent decades, particularly with fentanyl.
Read alsoOpioids and opiates: what are these painkillers that can cause dangerous addiction?
In France, the situation is not comparable, but many health professionals are concerned about an increase in cases of misuse of opioids such as tramadol, particularly used as a sedative.
Since 2017, all medicines containing codeine have been subject to a medical prescription. In 2020, the maximum prescription period for medicines containing tramadol was reduced to 12 weeks.
The ANSM has also asked manufacturers to market tramadol boxes containing fewer tablets, suitable for short-term treatments. Despite these efforts, various surveys have shown the persistence of cases of abuse, overdoses or dependence, hence the need for new measures.
The ANSM is now considering how to better inform patients about the risks associated with these drugs. For example, it is considering asking laboratories to put warning notices on boxes containing tramadol or codeine.
In 2022, tramadol abuse led to 14 deaths in France
Some 10 million French people received at least one prescription for opioid painkillers in 2015, according to the latest report drawn up by the ANSM in 2019. In 2022, tramadol abuse led to 14 deaths in France, and codeine abuse led to 6 deaths in the same year.
"Last year, the number of tramadol tablets prescribed decreased by 6% compared to 2022: fewer are prescribed, now they need to be used better", pleaded Philippe Vella.