Post Marketing Surveillance Methods – USA

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Post Marketing Survelliance Methods – USA

Pharmacovigilance: The science activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug related problems.

Post Marketing Surveillance: It is monitoring the safety of a pharmaceutical drug or a medical device after it has been released in market.

FDA maintains a system of post marketing surveillance and risk assessment programs to identify adverse events such as adverse reactions and poisonings.

FAERS: FDA Adverse Event Reporting System is a computerized information database designed to support the FDA’s post marketing safety surveillance program for all approved drug and therapeutic biological products.

The reports in FAERS are evaluated by multidisciplinary staff safety evaluators, epidemiologists and other scientists in the Center for Drug Evaluation and Research’s (CDER) office of surveillance and epidemiology to detect safety signals and to monitor drug safety.

MedWatch: The program is for health professionals and the public to voluntarily report serious reactions and problems with medical products such as drugs and medical devices. It also ensures that new safety information is communicated to the medical community thereby improving patient care. Al  data contained in medwatch form will be entered into the  AERS database.

Types of Post marketing Surveillance:-

  • Spontaneous/Voluntary reporting of cases
    • National-USA(FDA Med Watch)
    • Local or Regional (Joint commission Requirement)
    • Scientific Literature Publications
  • Post marketing Studies (voluntary or Required)
    • Observational studies
    • Randomised Clinical trial
  • Active Surveillance
    • Drug induced Liver injury Network(DILIN)
    • Sentinel Initiative

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