alexa Abstract | Starting-Up A Pharmacovigilance Network from Scratch: A Brief Plan

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Before releasing a drug in market, international drug regulatory agencies follow a common system to assess the safety and efficacy of a drug through preclinical and clinical trials. However, these pre-market evaluations are regarded as incomplete, which is the reason why post-market surveillances are constantly conducted to monitor the safety aspects of drugs as well as to detect adverse drug events. Pharmacovigilance (PV) is primarily concerned with the identification of adverse drug reactions (ADRs) and reduction of the associated risks. The detection of ADRs mainly depends on spontaneous reporting, stimulated post-marketing surveillance, and case-control studies. Detecting and reporting ADRs can make the trend of prescribing of medicines much safer and realize its aims. These are only possible if the pharmaceutical companies and patients from different places of a particular region report regularly on their adverse drug reactions. A PV network can harness these data by a systematic fashion from different levels of a social health care environment. Building-up an effective network calls for synchronization of different criteria, which again requires a perfect plan to set-up from early on. Basic steps in setting up a PV network include: creating guidelines, setting up of PV centers and capacitating its performance, data acquisition through ADR reporting form, creating public awareness for ADR reporting, detecting signals on an adverse drug events, and keeping connected with higher authorities. This article shortly reviews on these essentials, which a robust PV system demands for.

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Author(s): Partha S. Saha

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