Update : 220831_SGU
Source :https://www.medicabase.fr/
Presentation:
Medicabase is a non-profit association of drug database editors. Its purpose is to build and make available semantic repositories contributing to the interoperability of the medication circuit. It also plays a role in the e-health sector through its expertise and analysis work with players in this field.
Medicabase intends to disseminate widely and in a non-commercial manner the reference materials it produces.
Medicabase Virtual Drug Repository
The virtual drug repository is intended to enable the interoperability of virtual drugs in the context of DC prescribing. The repository is mainly intended to be used through professional software for prescribing or dispensing.
The repository is available for download under licence. By accessing and downloading the content, the user acknowledges that he/she has read the terms of this licence and accepts them unconditionally.
To facilitate integration into business software, the repository will also be disseminated to Medicabase member drug databases according to their own timetable.
The list of databases integrating this repository to date are
- Claude Bernard
- Theriaque
- Thesorimed
- VIDAL
Technical Annex :
The Medicabase virtual drug repository is based on a unique alphanumeric identifier (MV + 8 digits) and a descriptive label of the interoperable virtual drug.
This wording consists of the name of the active substance(s) in common name, the respective strength of each substance and the pharmaceutical form.
The repository is updated monthly.
Detailed description of the virtual medicine interoperability repository.
Scope of the interoperability framework :
It includes all the specialities that are or have been marketed in France for the last three years, with the exception of
- specialities for which the Common Name is not required for an electronic prescription
- specialities that the working group decided to exclude due to the nature of their composition (medical gases, Prodrogue...)
Model of the repository :
The virtual drug is defined by 3 components.
Active substance(s), strength(s) and pharmaceutical form
These three components are derived from recognised benchmarks.
- Substances :
The reference used to describe the substances is the list(1) of substances published by the EMA: eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD).
The substances in this repository are managed according to the ISO 11238:2012 IDMP2 standard (it has been implemented in particular to fill in the data for the "Article 57(2)" database)
(1)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04/WC500142231.xlsx
(2)IDMP: identification of medicinal products
- Pharmaceutical form
The standard used to describe the shapes is the Standard Terms published by the EDQM*.
In the framework of the interoperability repository, terms relating to pharmaceutical forms and combined terms relating to pharmaceutical forms were retained.
* https://standardterms.edqm.eu/
- Units
The standard used to describe the units of substance dosages is the UCUM*.
Grammar with implementation of a set of characters, symbols and lexical and syntactic rules
* Unified Code for Units of Measure (http://unitsofmeasure.org)
Rules of constitution :
-> Dosage
The dosage is accompanied by a "base" indicator (Boolean) to indicate its mode of expression (base or salt)
The numerical value is expressed as a figure
The unit is expressed according to the UCUM reference system
Rule of writing: above 1000 mg: the unit "g" is used.
. Unitary" form
The expression of the dosage is the amount of substance contained in the unit under consideration
Example: Indometacin 25 mg capsule
. Multi-dose form
The dosage can be expressed as a concentration or as a percentage, in the latter case with the precision of the concentration
Examples:
Pamidronic acid disodium salt 15 mg/ml solution for infusion
Acetylcysteine 2% (20 mg/ml) oral solution
. Transdermal devices
3 rules can be applied depending on the type of device
24-hour device (most common case):
the expression of the dose is indicated by 24h
Example: Nicotine 14 mg/24h transdermal device
a device that can be administered over a period other than 24 hours
the expression of the dose takes the period as indicated
Example: Nicotine 15 mg/16 h transdermal device
drugs
the dose expression is given per hour
ExampleFentanyl 12 µg/h transdermal device
-Information missing from the core repositories
Creation after collegial agreement of the group managing the repository with allocation of a provisional internal identifier.
Application to the competent authorities for establishment.
.Substances
Assignment of a temporary internal identifier code starting with the key letters TS followed by 6 digits (e.g. TS000010)
Application to the EMA for establishment
.Units
Application to the body that manages this repository
. Pharmaceutical forms
Assignment of a temporary internal identifier code starting with the key letters TS followed by 6 digits (example TF000025)
Application to the ANSM (EDQM contact person)
Naming and writing rules
. The wording of a virtual medicine starts with a capital letter
. The order of the substances is alphabetical
. The wording of the substances(1) is in accented lower case
.Dosage
It is placed immediately after the substance
The "substance - dosage" pairs are separated by a "+" sign preceded and followed by a space
If the dosage is expressed as a base, the salt is put in brackets.
A zero precedes the decimal separator for numbers displayed below 1
No comma or full stop is used as a thousand separator but a space
. Pharmaceutical form
French wording of the Standard terms
In full and accented lower case
Preceded by a space, it follows the list of "substance-dosage" pairs
(1) INN recommended by the WHO, failing which, the name of the European or French pharmacopoeia or, failing that, the usual common name (Article R.5121-1 of the Public Health Code)
Principles of repository maintenance
Management is collaborative.
