The legislation provides the opportunity for doctors and dentists to prescribe medicines in INN. They can therefore ignore the different names and packages of medicines containing the same active ingredient, the same dose and same route of administration.
In this matter pharmacists give advice about rational use of medicines, price comparison and choice of appropriate packaging. To help them in their mission, the Federal Agency for Medicines and Health Products (FAMHP) wrote a note to set in operation the "INN prescription” law. A file containing the different INN groups, provisionally in pdf format, is available on the website of the Belgian Centre for Pharmacotherapeutic Information (BCPI). An easily searchable database will be shortly developed by the BCPI.
The Royal Decree of 10th August 2005 fixed the terms of prescription for human use, including the INN prescription.
A INN prescription is a prescription where a prescriptive "INN group” is identified and prescribed with or without supplementary specification.
An "INN Group" is a set of drug packs available on the market that share the same active substance (or combination of active substances), the same dosage and same route of administration. This set may be designated by a single formulation of INN prescription (e.g., Ibuprofen 200 mg oral).
At the request of the Federal Public Health Service (Project Be-prescription-II), the Belgian Centre for Pharmacotherapeutic Information (BCIP) in 2007 brought together a group of experts to propose solutions for the practical application of legislation in this matter. In 2008 the recommendations of this panel were discussed in a working group "Proposals for the practical application of the INN prescription” within FAMHP by experts of the FAMHP and the CBIP, later joined by members of the Committee for medicines for human use.Experts from insurance organizations and the “INAMI” have also been consulted.
The discussions led to the drafting of a note (French version) approved by the Commission for medicines for human use on 20/11/2009, laying down the principles for defining groups of medicines that can be grouped under a single INN prescription and any mandatory or optional specifications of this prescription.
Based on this note (French version), a practical process has been established by the BCIP to classify medicines marketed in INN groups with any relevant specifications. This file which can be integrated into the medical and pharmaceutical software, is also available, provisionally in pdf format,on the CBIP website and will be updated monthly. An on line searchable database will be very soon developed by the BCPI for ease of use.
Some important details about "INN groups”
- An "INN Group” is defined by the combination of three major characteristics: active substance (or combination of active substances), dosage and route of administration.
- In some INN groups additional specifications may be important, such as modified release or the different vehicles for dermatological medicines. In these cases, the prescriber is required to make a choice.
For other specifications (e.g. breakable, soluble, gastro-resistant ...), the prescriber must indicate freely his choices and preferences. - For some groups of medicines it is recommended to maintain the initial choice of medicine for continuing the treatment and to avoid shifts. These groups of medicines are designated by the code "NO_SWITCH”.
- Some groups of medicines are not included in the INN prescription system. They are listed in the list of medicines ordered by the INN group with the code "NO DCI" / " NO VOS”.
Other relevant information can be found in the aforementioned note (French version).