Monografías de Medicamentos : Vidal Política Editorial

The Vidal Medication Monographs provide pharmacological and therapeutic information about medicinal products to health professionals; this is offered in addition to the published regulatory information.

The Medication Monographs describe the therapeutic properties as presented by a medicinal product represented by its active ingredient substance(s), their strength(s) and the pharmaceutical dose form that contains them.

The Vidal Medication Monographs provide consolidated information gathered from various sources including the official information of the appropriate group of marketed products and as such represents a non-proprietary view of a medication. Therefore, the Vidal Medication Monograph does not include characteristics specific to individual marketed products, such as excipient information or economic information. This information must be sourced from individual products directly.

Editorial Policy

The Vidal team conducts daily monitoring of medication information coming from official sources and international scientific publications (see the Appendix for a list) and from this maintains and updates the information in the Vidal Medication Monographs accordingly. The Vidal multidisciplinary team of healthcare professionals (doctors, pharmacists) assesses the information coming from the various sources and synthesises it into the monograph. If there is conflicting information, this team works systematically to reach a consensus view. The source information is international, but the monograph is written in French then translated into other languages as required for the locations of monograph users.

Versioning

There are potentially two dates present on a Vidal Medication Monograph:

Revision date: the date that the full set of monograph information has been reviewed and validated by the Vidal team. This date may not be present on some monographs, since this date has been recently introduced (2022). If there is no Revision date present, the monograph may not fully reflect current therapeutic knowledge.
Modification date: the date of the last update of one or more sections within the Medication Monograph

Healthcare professional user feedback

Comments and requests for additional information, especially in relation to quality and safety are systematically evaluated by the Vidal team.

Content of the Medication Monograph

The name of the medication described by its
- Therapeutic substance(s) with their strength
- Pharmaceutical dose form
- Route of administration
ATC classification(s)
Risks in pregnancy, lactation and for fertility
Anti-doping information
Risks associated with driving a vehicle or operating machinery
Indications – these reflect the main indications for use in France and Europe and more widely in other countries as described in the source information available
Dosage information, both in text and as structured data
Physico-chemical incompatibilities
Patient information
Instructions for patient care during treatment
Methods for administration of the medication
Specific risks of the treatment, highlighting to healthcare professionals the potential occurrence of frequent or severe or newly reported adverse events
Patient monitoring requirements, before initiating treatment, during treatment or after stopping treatment
Any situations which require permanent discontinuation of treatment
Interactions with other medications or with foods
Contraindications
Precautions for use
Undesirable effects, organised by body system and by frequency of occurrence

Annex

Non-exhaustive list of information sources used to author Vidal Medication Monographs

From medicines regulatory agencies:

Europe:

European Medicines Agency
Agence Nationale de Sécurité du Médicament et des Produits de Santé (France)
Agencia Española de Medicamentos y Productos Sanitarios (Spain)
The Health Products Regulatory Authority (Ireland)
Agenzia Italiana del Farmaco (Italy)
Agence Fédérale des Médicaments et des Produits de Santé (Belgium)
Medicines and Healthcare products Regulatory Agency (United Kingdom)

The Americas:

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (Argentina)

Other reference sources:

DailyMed (USA)
Infomed (Portugal)
Compendium Suisse (Switzerland)
Gelbe Liste (Germany)
Colegio farmaceutico (Chile)
Actuamed (Mexico)
Therapeutic Goods Administration (Australia)
Centre de Référence sur les Agents Tératogènes (France)
Micromedex (USA)
WADA – World Anti-Doping Agency
World Health Organization
Stockley's Drug Interactions (United Kingdom)