2024-12-10 06:39:00
The over-the-counter sale of eight cold medicines in pharmacies is now a thing of the past. Starting this Wednesday, December 11, patients will have to have a prescription to obtain these treatments in French pharmacies, the National Agency for the Safety of Medicines and Health Products (ANSM) announced on Tuesday, December 10.
The drug cop believes these treatments using pseudoephedrine, a vasoconstrictor used to relieve cold symptoms (runny nose, stuffy nose), pose too great a risk given this temporary benign condition. In very rare cases, pseudoephedrine can cause serious side effects, including stroke, myocardial infarction, angioedema, and even anaphylactic shock.
With the approach of the winter season, the period in which these products are most consumed, the health authority has thus decided to limit access by making delivery subject to a medical prescription. “We ask prescribers to carefully evaluate the risk/benefit ratio for each patient before prescribing any of these drugs”indicates the ANSM.
A decision is expected
Eight drugs are affected by this measure: Actifed Cold, Actifed Cold day and night, Dolirhume Paracetamol and Pseudoephedrine, dolirhumepro Paracetamol Pseudoephedrine and Doxylamine, Humex Cold, Nurofen Cold, RhinAdvil Cold Ibuprofen/Pseudoephedrine and RhinAdvilcaps Cold. Ibuprofen/Pseudoephedrine.
This decision, acclaimed by numerous scientific societies and of which the professional organizations representing pharmacists had been previously informed, was expected. In 2023, concerned following new data regarding a small number of cases of posterior reversible encephalopathy syndromes and reversible cerebral vasoconstriction syndromes in patients using drugs containing pseudoephedrine, the Italian health authority had seized the European Medicines Agency, hoping that he would revoke the marketing authorization for these products. At the end of a revaluation,the latter still retained the right to sell on the European market,judging the risks too rare to prohibit thier use. It did, though, require laboratories to strengthen the list of warnings and contraindications on the instructions.
What implications will the new prescription requirement for cold medicines in France have on patient access to these treatments?
Q&A: The New Prescription Requirement for Cold Medicines in France
Editor: Thank you for joining us today. We’re hear to discuss a significant change in the pharmaceutical landscape in france, which requires patients to have a prescription to obtain eight popular cold medicines starting December 11. Can you elaborate on why the National Agency for the Safety of medicines and Health Products (ANSM) made this decision?
Expert: Absolutely. The ANSM’s primary concern centers around the risks associated with pseudoephedrine, a common ingredient in manny cold treatments. While these medications are typically used for temporary, benign conditions like colds, they have been linked to serious side effects. The decision aims to safeguard public health by ensuring thorough evaluation of these risks by medical professionals before prescribing these products.
Editor: That’s an important consideration.can you detail which specific medications are impacted by this new regulation?
Expert: Certainly. The eight cold medications affected include actifed Cold, Actifed Cold day and night, Dolirhume Paracetamol and Pseudoephedrine, Dolirhumepro Paracetamol Pseudoephedrine and Doxylamine, Humex Cold, Nurofen Cold, RhinAdvil Cold Ibuprofen/Pseudoephedrine, and RhinAdvilcaps Cold Ibuprofen/Pseudoephedrine. Starting December 11, these will only be available through a prescription in pharmacies.
Editor: What prompted this action at this particular time, especially with winter approaching when these products are most consumed?
Expert: With the winter season, there’s usually a significant surge in cold cases. the health authority has recognized that the risks associated with pseudoephedrine might not be justifiable for treating mild symptoms. By requiring prescriptions, they ensure that healthcare providers evaluate the risk-to-benefit ratio, which is essential given the potential severe side effects such as stroke or allergic reactions that can occur in rare circumstances.
Editor: It sounds like a proactive measure for public safety. How do you see this change impacting both patients and healthcare professionals in France?
Expert: For patients, this means they’ll need to consult with their healthcare providers before obtaining these medications, which could delay treatment for cold symptoms. However, it ensures they receive appropriate medical advice tailored to their health background. For healthcare professionals, this regulation emphasizes the importance of a detailed patient assessment, ultimately encouraging a more cautious and responsible approach to prescribing medications known for their risks.
Editor: Given the increased scrutiny and the potential for delays in treatment, what advice would you offer to patients looking for relief from cold symptoms?
Expert: Patients should consult their healthcare providers if they experience cold symptoms, even if they feel mild. There are numerous safe alternatives and over-the-counter medications without pseudoephedrine available. Also,engaging in preventive measures,such as maintaining good hygiene and getting vaccinated against seasonal flu,can help reduce the likelihood of contracting colds.
Editor: As we close this discussion, what long-term implications do you foresee for the pharmaceutical industry following this change?
Expert: this could initiate a broader trend where more medications are evaluated under stringent scrutiny, particularly those containing ingredients with potential risks. It’s also probable that pharmaceutical companies may need to invest more in research to develop safer alternatives. this shift could enhance patient safety but may also require adjustment in the pharmaceutical industry’s approach to marketing and distributing certain medications.
Editor: Thank you for your insights! It’s clear that while the new prescription requirement for cold medicines may present challenges, the primary goal is to prioritize patient safety and well-informed healthcare decisions.
Expert: Thank you for having me! It’s an essential conversation that affects us all.