Due to the strong supply tensions in Quétiapine, the ANSM asks the prescribers to reserve this drug for patients with bipolar disorders and obliges pharmacists to use unit dispensation.
- The production difficulties of the manufacturer Pharmathen International lead to strong tensions of supply of Quétiapine in France.
- Faced with this situation, the ANSM asks doctors to prescribe a therapeutic alternative to quetiapine, for the initiation of treatment and for patients under treatment.
- On the pharmacists’ side, the ANSM forces them, now, to resort to unit dispensation (DAU) for the tablets of Quétiapine LP (prolonged liberation) 50 mg.
In recent weeks, Quétiapine is missing in France. Manufacturer’s production difficulties Pharmathen International lead to strong supply tensions on this antipsychotic, sold under the name Xeroquel or other generics.
Change the prescription of Quetiapine
Normally, quetiapine is prescribed for the treatment of schizophrenia, bipolar disorders and major depression. But faced with strong supply tensions, the National Agency for the Safety of Medicines and Health Products (ANSM) asks doctors to prescribe a “Therapeutic alternative to initiation of treatment and now also for patients under treatment, as soon as possible, for all indications except in the event of a depressed episode characterized within the framework of a bipolar disorder”, Can we read in a press release.
On January 30, the ANSM was already alerted to the quetiapine supply tensions on “All dosages“Available of the prolonged release form (LP). The body asked doctors to no longer initiate treatment with Quétiapine LP, except in cases of characterized depressive episodes linked to a bipolar disorder. Now, this recommendation is therefore also valid for patients under treatment.
Unit dispensation made compulsory by the ANSM
On the pharmacist side, the ANSM obliges them, as of now, to “Use unit dispensation (DAU) for Quétiapine LP 50 mg tablets, especially during treatment initiations”. It is also specified that the DAU is possible for the LP 300 mg and LP 400 mg dosages. The goal is, as for the Dau of antibioticsto deliver exactly the dose that the patient needs, to avoid storage or waste.
From February 17, another solution will be implemented: the possibility of using masterful preparations from Quétiapine to immediate Liberation (LI) “in the form of 100 mg and 150 mg capsules”. According to theHealth insurancewhich takes up the definition of the public health code, a masterful preparation is a “drug prepared given the prescription intended for a determined patient …”. In other words, it is a drug made in one of the pharmacies authorized to do so in France.
“” “If the Quetiapine LP initially prescribed is not available, you will be able to provide a masterful preparation to replace, exceptionally and temporary, without modification of prescription, specifies the ANSM. This replacement must be made on the basis of the equivalence table of LP and Li of Quétiapine forms. When you provide masterful preparations of Quétiapine Li in application of the recommendation, you must imperatively and by all possible means, prevent the doctor from this change”.
For patients, the ANSM warns that the transition from Quétiapine LP to Li can cause drowsiness and dizziness. In the event of a change, the pharmacist will accompany you by explaining the possible side effects and the changes in dosage.
