Pharmacovigilance and Beyond

Forensic pharmacovigilance.

Active pharmacovigilance and healthcare utilization.

OBJECTIVES While active surveillance for adverse drug events using electronic medical records (EMRs) and claims data is expanding, these data do not fully capture patient experiences with medication-related symptoms. Our objective was to describe adherence and outcomes associated with an automated pharmacovigilance call. STUDY DESIGN/METHODS Prospective cohort of patients receiving a prescrip...

[Pharmacovigilance in clinical trials].

Prema definiciji Svetske zdravstvene organizacije farmakovigilanca je nauka ili skup aktivnosti povezanih sa detekcijom, procenom, razumevanjem i prevencijom neželjenih efekata ili bilo kojih drugih problema povezanih sa upotrebom lekova . Pod farmakovigilancom se, generalno, smatralo postmarketinško praćenje neželjenih efekata lekova u četvrtoj fazi kliničkih istraživanja lekova . Međutim, sa ...

Pharmacovigilance in perspective.

Pharmacovigilance is more than spontaneous reporting alone, and the evaluation of marketed medicines is more than just pharmacovigilance. The positioning of a drug usually takes place during the years following introduction, when worldwide experience has accumulated. Originally a modest appendix of drug regulation, pharmacovigilance has become a major activity. The provision of the information ...

Pharmacovigilance of Oncology Biosimilars

Biologicals are critical in cancer medicine. Four of the top ten biological blockbusters worldwide are oncology drugs used for therapeutic or supportive care. The global market for biologic cancer therapies approximately totalled US$ 51.2 billion in 2014 and is expected to reach US$ 66.4 billion in 2019. The patents of most of these top-selling agents will expire by the year 2020 attracting ind...