The WHO (World Health Organization) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Main objectives of Pharmacovigilance 

  • Early detection of adverse effects and unknown interactions.
  • Detection of increases in the frequency of adverse reactions (known).
  • Identification of risk factors and the possible underlying mechanisms of adverse reactions.
  • Estimation of the quantitative aspects of the benefit / risk ratio and dissemination of the necessary information to improve the regulation and drugs prescriptions.

Wich are the final goals of Pharmacovigilance?

  • A rational and safe use of drugs.
  • The assessment and communication of risks and benefits of commercialized drugs.
  • The education and information to patients.

What is an adverse event?

  • Known event (Prospect)
  • Unknown event
  • Result of laboratory tests
  • Pregnancy/Congenital abnormalities
  • Death/Fatal result
  • Lack of effectiveness
  • Worsening of the underlying disease
  • Overdose
  • Drug interaction
  • Abuse / Misuse
  • Dependency
  • Poor administration of medication

Unid of Pharmacovigilance

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