Ibuprofen, Ansm: "Abuse is harmful and sales must be mediated by the pharmacist"
LFrench Medicines Agency asked pharmacists to place drugs based on paracetamol and ibuprofen behind the counter so that access by consumers is mediated by the presence of these. In France, in fact, all non-prescription drugs are open to the public. NIn our country things are different because the macro-category that includes non-prescription drugs have two sub-categories: "self-medication" or "over the counter" drugs in the initials OTC (from the English over the counter, "over the counter") and drugs "without prescription" in the initials SOP, or as the association calls them more appropriately Assosalute category, "SP", or "without advertising". And yes, because the only difference between the two categories is whether or not they can advertise directly to the public. Possibility granted to OTCs and denied to SOPs / SPs.
Distinguishing them is not easy because you need to look at the marketing authorization on a case-by-case basis. For example, Tachiprine (based on acetaminophen) is an Otc drug in the 250mg dosage but changes category in the 1000mg dosage. Nurofen, on the other hand, is always an OTC.
Let's go back to France. Why did the ANSM ask to change the position of these drugs? "These are drugs - he explains - widely usedIt is good that patients can access it, but we must do our best to ensure that they are used correctly, ”explains Dr. Philippe Vella, director of analgesic drugs Ansm, stressing the importance of the role of the pharmacist. In high doses, paracetamol can cause severe liver damage, which may require transplants or even death".
The Agency would like this measure to enter into force in January 2020. A "contradictory procedure" is underway in the laboratories concerned, so that they can explain their position. It is at the end of this procedure that the final decision will be made.