L’Supply of the specialties CONCERTA LP 18 mg, LP 36 mg and LP 54 mg prolonged-release tablet (methylphenidate) and their generics (Biogaran, Viatris) remains very disrupted. As of November 4, 2024, the situation reported by the National Agency for the Safety of Medicines and Health Products (ANSM) is as follows: [1] :
- supply tension for CONCERTA LP 18 mg and CONCERTA LP 54 mg dosages: limited distribution in town;
- rupture de stock de CONCERTA LP 36 mg ;
- normal availability indefinitely.
How to replace CONCERTA LP if unavailable?
In this context and to ensure continuity of treatment for patients despite the unavailability of their usual medication, the ANSM has updated its recommendation allowing the replacement by pharmacists of the specialty of methylphenidate prescribed, without presentation of a new prescription by the patient [2].
The first version of this recommendation issued in February 2024 concerned the replacement of the drugs QUASYM LP, RITALINE LP and METHYLPHENIDATE ARROW LP by MEDIKINET (cf. our article of February 29, 2024).
The updated version concerns in particular the replacement of CONCERTA LP or one of its generics by MEDIKINET modified-release capsule or RITALINE LP prolonged-release capsule. But it also deals with the replacement of QUASYM LP and METHYLPHENIDATE ARROW LP (cf. paragraph below).
The specialties RITALINE LP 10 mg, 20 mg and 30 mg are no longer affected by supply tensions and are available again.
Concerning RITALINE LP 40 mg, the tension is persistent (cf. our article on stock shortages from November 5, 2024).
If the prescribed specialty is CONCERTA LP or a generic, and this specialty is unavailable, the replacement instructions issued by the ANSM are as follows:
- replacement of CONCERTA LP 18 mg or its generics by:
- MEDIKINET 10 mg in the morning and MEDIKINET 10 mg at midday (i.e. 5 hours apart between each dose)
- or RITALINE LP 20 mg in the morning
- replacement of CONCERTA LP 36 mg or its generics by:
- MEDIKINET 20 mg in the morning and MEDIKINET 15 mg at midday (corresponding to MEDIKINET 10 mg + MEDIKINET 5 mg) (i.e. 5 hours interval between taking in the morning and at midday)
- or RITALINE LP 20 mg in the morning and RITALINE LP 10 mg at midday
- replacement of CONCERTA LP 54 mg or its generics by:
- MEDIKINET 30 mg in the morning and MEDIKINET 20 mg at midday (i.e. 5 hours apart between each dose)
- RITALINE LP 30 mg in the morning and RITALINE LP 20 mg at midday.
How to replace QUASYM LP and METHYLPHENIDATE ARROW LP if unavailable?
If the prescribed specialties are QUASYM LP 10 mg, 20 mg and 30 mg modified release capsule, and these specialties are unavailable, the instructions issued in the updated version of the ANSM recommend replacement by:
- MEDIKINET 10 mg, 20 mg or 30 mg, modified release capsule;
OR
- RITALINE LP 10 mg, 20 mg or 30 mg, prolonged release capsule.
If the prescribed specialties are METHYLPHENIDATE ARROW LP 10 mg, 20 mg or 30 mg prolonged-release capsule, and these specialties are unavailable, the instructions issued in the updated version of the ANSM recommend replacement by:
- MEDIKINET 10 mg, 20 mg or 30 mg, modified release capsule;
OR
- RITALINE LP 10 mg, 20 mg or 30 mg, prolonged release capsule.
Replacement conditions and information to be given to patients
In the event of a replacement, the community pharmacist must respect the following instructions:
- the dosage delivered as a replacement must correspond to the dosage of the prescribed specialty, in accordance with the recommendations issued by the ANSM;
- the name of the medicine dispensed must be written on the prescription;
- the prescriber must be informed by any means;
- the patient must be warned of the replacement of specialty, and of the possible consequences of this change of specialty, particularly in terms of coverage of symptoms during the day which may be modified taking into account the different release kinetics of methylphenidate between these specialties ;
- if the MEDIKINET specialty is supplied as a replacement: this medication must be taken during or after meals;
- patients who were treated with METHYLPHENIDATE ARROW must be informed that MEDIKINET contains an excipient with a known effect: sucrose (which METHYLPHENIDATE ARROW does not contain);
- The patient should contact their doctor in the event of an adverse effect or the appearance of a symptom that they consider unusual. The dosage can then be adapted by the doctor, depending on the patient’s response.
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