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Pharmaceutical Regulatory Affairs: Open Access

Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access
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Drug Safety Open Access

Pharmacovigilance (PV or PhV), also known as pharmacovigilance, is pharmacological science related to the collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products. The etymological roots of the word 'pharmacovigilance' are: pharmakon (Drug Greek) and vigilare (Latin for watch). As such, pharmacovigilance focuses heavily on adverse drug reactions, or ADRs, defined as any reaction to a drug that is noxious and unintended, including lack of efficacy. Also, of concern are prescription errors such as overdose, misuse and abuse of a drug, as well as drug use during pregnancy and breastfeeding, often without an adverse effect, because they can result in an adverse drug reaction. Information obtained through pharmacovigilance agreements (PVAs) from patients and healthcare professionals, as well as other sources such as medical literature, plays a vital role in providing the evidence required for pharmacovigilance to take effect. In addition, in order to sell or check a pharmaceutical product in most countries, data obtained by the licensee must be submitted on adverse events.

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Citations: 533

Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report

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