Recommendations have just been issued by the ANSM with the aim of alleviating the global shortage of certain flecainide-based drugs indicated for heart rhythm disorders.
- Sustained-release flecainide, a treatment for cardiac arrhythmias, is experiencing supply constraints globally.
- Recommendations have been issued by the ANSM (National Agency for the Safety of Medicines and Health Products) to compensate for this shortage.
- The pharmacist can substitute the missing medication without medical advice. But the attending physician must be consulted in the event of a problem or adjustment of treatment.
The ANSM (National Agency for the Safety of Medicines and Health Products) announced, on August 31, 2023, compensation measures in the face of global supply tensions for so-called LP drugs (sustained release, i.e. long-acting) containing flecainide, usually prescribed against heart rhythm disorders.
Flecainide: global supply tensions
Already in supply tension since the July 19, 2023, measures aimed at finding effective solutions to this problem have therefore been transmitted to health professionals (doctors and pharmacists) but also to patients. According to the laboratories, these tensions are due to difficulties in supplying raw materials and packaging items (packaging of the drug to protect against shock and allow conservation).
A major role for the pharmacist
As the ANSM indicates, these recommendations have “aims to facilitate the implementation of a replacement treatment adapted to each individual situation, either directly at the level of community pharmacies, or following medical advice, if another molecule must be used as a replacement..
Thus, if the antiarrhythmic drug (Flécainide LP) is unavailable, it can be replaced by other equivalent drugs. This modification can be made directly by the pharmacistwithout medical advice, thanks to a precise reference system.
The pharmacist must then inform the patient of this change. He will also advise him to see his doctor in the event of adverse effects or symptoms that the patient considers unusual.
But be careful, the name of the new medication dispensed must be specified by the pharmacist on the patient’s prescription. And the healthcare professional must also notify the doctor of this modification.
A situation of indefinite duration
It is also necessary to consult your doctor if the pharmacist has not been able to give an equivalent medication. The general practitioner or cardiologist will then be able to adapt the treatment appropriately.
A return to normal is strongly hoped for but no date is known at this time.