In Biotoscana Group we believe in patient’s safety and to guarantee it we work constantly in detecting, evaluating, understanding and preventing adverse effects and other problems related to medicines. With your help and the collaboration of our partners, we seek to ease the report of adverse events. To report an adverse event, please contact us in: farmacovigilancia.chile@grupobiotoscana.com.
An adverse event is defined as any unwanted medical incidents related, temporarily, to the use of a medicine, or an unfavorable signal (including, for example, an unusual exam result), symptom or disease presented by a patient that has used the medicine, and that, not necessarily has a causal relation with the treatment, including:
- Adverse events related to quality complains
- Adverse events related to non-approved use of the medicine
- Drug interactions
- Treatment’s inefficiency
- Poisoning related to the medicine
- Overdose, improper use or medication errors
- Errors in the medication
- Pregnancy/ nursing while using the medicine (related or not to na adverse effect)
- Suspected transmission of an infectious agent through a medicine
- Adverse Drug Reaction (ADR) is defined as “a response to a drug which is noxious
- and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function” (WHO)
Serious adverse events:
The following are considered serious adverse events:
- Death
- Life threat
- Permanent invalidity or disability
- Congenital anomalies/ defects
- That has as a consequence hospitalization or extension of hospitalization
The informations about adverse events can come from:
- Healthcare professionals
- Medical research
- Patients, relatives or caregivers
- Biotoscana Group Employees