suspected adverse reactions, that is, the undesirable experiences that occur in patients with pharmacological treatment when the health professional considers that there could be a causal association with the drug. However, if in doubt, please notify.
Medicines are considered: prescription drugs, advertising drugs, vaccines, radiopharmaceuticals, medicinal plants, master formulas, homeopathic medicines and medicinal gases.
From the program it is stimulated particularly the notice of:
- With recently marketed drugs:
- Any suspected adverse reaction.
- With all medications:
- Suspected clinically significant or serious adverse reactions, that is, those that have determined or in which there has been a risk of death, that have been the cause of admission to a hospital or prolonged the period of hospitalization or that have produced permanent or significant disability .
- Suspected adverse reactions not described in the drug information.
- Congenital malformations suspected to have been caused by a drug.
El Spontaneous Notification Program of Suspected Adverse Drug Reactions It encompasses all activities aimed at the identification, quantification, evaluation and prevention of the risks associated with medicines in the population once they are marketed.
Its objective is to identify early the possible risks associated with the use of medicines. For this, the collaboration of health professionals contributing their clinical cases is essential.
The notifications that are received are evaluated and registered in technical pharmacological surveillance units. With the information received, a signal or working hypothesis can be generated that will need to be analyzed with other working methods.
In 1983, Spain joined the International Collaborative Program that has been in operation since 1970 and in which more than 50 countries participate. The Spanish Pharmacovigilance System develops this program that integrates the activities of the Autonomous Pharmacovigilance Centers and a Coordinating Center, dependent on the Spanish Agency for Medicines and Health Products.