Pharmacovigilance

Pharmacovigilance is a fundamental tool for Patient Safety.

Asofarma maintains documented processes, activities and procedures that ensure the functioning of the Pharmacovigilance System within the organization, in order to:

  • Keep the risk profile of our pharmaceutical products updated.
  • Comply with local regulatory requirements in Pharmacovigilance and with the requirements of our partners.
  • Be one step ahead of the requests from LATAM regulatory agencies and aligned with the EMA and FDA guidelines of Good Pharmacovigilance Practices.
  • Articulate with all stakeholders (internal and external) to add value and contribute to the business, focused on patient safety.

The Pharmacovigilance Department has a structure with personnel dedicated to the Pharmacovigilance System, made up of specifically trained health professionals who are part of the Medical Department.

Asofarma has a Pharmacovigilance manager and their corresponding Back-up, both health professionals, who maintain the Pharmacovigilance System at the local level following the corporate guidelines and at the same time, complying with national regulations.

Report of
Adverse Events

One of the main activities of Pharmacovigilance is the reception, evaluation and communication of Adverse Events, Quality Claims or other safety information of interest associated with the use of our pharmaceutical products.

Adverse Event (AE):

Any adverse medical event in a patient who is administered a medicinal product and that does not necessarily have a causal relationship with this treatment. Therefore, an adverse event can be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with the use of a medicinal product, whether or not it is related to this medicinal product.

(Reference: ICH-E10 “Post-approval Safety Data Management: Definitions and Standard for Expedited Reporting E2D”.

REPORT ADVERSE EVENT

Other security information of interest:

  • Off-label use (outside the prospectus).
  • Report of the usage results of the product during pregnancy.
  • Exposure of the fetus to the product through the father.
  • Report of adverse reactions during breastfeeding.
  • Data report about the use of the product in children and elderly patients.
  • Compassionate/Patient use reporting.
  • Report of lack of efficacy. Report of presumed transmission of infectious agents.
  • Report in relation to overdose, abuse and misuse, with or without adverse event.
  • Report of medication errors (with or without exposure to the patient).
  • Potential medication error.
  • Second Primary Malignant Neoplasm.
  • Report in the event of a public health emergency.
  • Occupational Exposure.
  • Accidental Exposure.
  • Drug interaction.