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A drug prescribed for heart rhythm disorders, extended-release flecanaide is experiencing supply constraints worldwide. To avoid leaving patients without a solution, the Medicines Agency has established replacement recommendations.
Who are flecainide medicines for?
Sustained-release flecainide medicines used to improve the symptoms of heart rhythm disorders. Concretely, this antiarrhythmic modifies the transmission of nerve impulses to the heart muscle and fights against anarchic contractions. It is also used in patients who have implantable cardiac defibrillators to reduce electric shocks.
Why are these drugs in short supply?
These drugs are currently in short supply worldwide. Problems that the laboratories explain by difficulties in supplying raw materials and packaging items. According to the ANSM, “A date for a return to normal supplies cannot yet be brought forward although supplies are regularly made..
So that the patients concerned can nevertheless receive appropriate treatment, the ANSM has developed recommendations for pharmacists and prescribing doctors, in consultation with the French Society of Cardiology and its rhythmology and cardiac stimulation group, unions and representatives of pharmacists. , the College of General Medicine and patient associations, including the association of wearers of electrical cardiac devices (Apodec).
The objective is to facilitate the implementation of a replacement treatment adapted to each situation, either directly via the pharmacist, or following medical advice, if another molecule must be used as a replacement.
What are the different alternatives?
The pharmacist must inform the patient when a replacement is necessary and advise him to see his doctor in the event of an adverse effect or symptom that he considers unusual. He also writes the name of the medicine dispensed on the prescription and informs the prescriber of this replacement.
Several solutions are considered depending on the availability of treatments:
First-line solution
If supplies are sufficient, replacement with another specialty flecainide sustained-release (PR), or immediate, should be preferred. For example: a 150 mg LP capsule can be replaced by a 50 mg LP capsule and a 100 mg LP capsule, to be taken once a day;
If prolonged-release forms are unavailable, the pharmacist may replace them with an immediate-release specialty, respecting the same prescribed daily dose, and informing the patient that the dose must be divided into 2 doses per day ( morning and evening). For example: 1 100 mg tablet to take morning and evening, instead of 1 200 mg LP capsule once a day.
2nd intention solution
If the prolonged release (LP) or immediate replacement specialties are out of stock, immediate release form magistral preparations of flecainide can be prepared with a raw material for pharmaceutical use. For example: Flécaine LP 150 mg 1 capsule per day = master preparation of Flécainide acetate 75 mg 1 capsule in the morning and 1 capsule in the evening.
Last solution requiring consultation with a cardiologist
As a last resort, flecainide can be replaced by a drug based on propafenone, after consultation with a cardiologist and upon presentation of a prescription. This consultation is necessary in order to control the patient’s heart rate, due to the bradycardic properties of propafenone (slowing down the heart rate). In addition, this substitution requires close monitoring, in particular by electrocardiogram on D8/D10, in order to check the patient’s heart rate. The dosage must be defined by the doctor on a case-by-case basis.
In summary, patients should know that:
If your treatment is unavailable, your pharmacist can give you another equivalent medication.
- Consult your doctor if:
- your pharmacist was not able to provide you with equivalent treatment, so that your doctor can adapt your care;
- unusual symptoms appear when you change your treatment.