International non-proprietary name (INN) prescriptions: version 8 of the “Operational rules for INN prescriptions in medical and pharmaceutical practice and in the electronic medical record”

date: 17/04/2020

The FAMHP's evaluators have finalised version 8 of the note “International non-proprietary name prescriptions – Operational rules for INN prescriptions in medical and pharmaceutical practice and in the electronic medical record”.

This review (version 8 see Dutch or French) concerns the therapeutic class of antiepileptics and was carried out in consultation with internal and external experts from the FAMHP, as well as with members of the Commission for Medicinal Products for Human Use (CMH). The review took place in three stages:

  1. examination of the new scientific data available concerning antiepileptics currently on the market, particularly in relation to their therapeutic index and switching between specialities;
  2. determination of antiepileptics with a narrow therapeutic range;
  3. assessment of the need for more general precautionary measures across the therapeutic class.

After consultation with the FAMHP’s partners and approval from the CMH, the FAMHP’s evaluators have amended the list of molecules with a narrow therapeutic range and/or those that are highly toxic (paragraph 7.1.2.). A new paragraph (7.2.2.) has also been added concerning switching between specialities during an antiepileptic treatment and the importance of dialogue between the patient and the doctor in this context.

Additional information

Contact

info.medicines@fagg-afmps.be

 

Last updated on 04/05/2020