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Pharmacovigilance
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products.
The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended. That definition includes lack of efficacy: that means that the doses normally used for prevention, diagnosis, or treatment of a disease—or, especially in the case of device, for the modification of physiological disorder function. In 2010, the European Union expanded PV to include medication errors such as overdose, misuse, and abuse of a drug as well as drug exposure during pregnancy and breastfeeding. These are monitored even in the absence of an adverse event, because they may result in an adverse drug reaction. The US FDA has long considered such criteria to conform to reportable and collectible PV standards.
Patient and healthcare provider reports (via pharmacovigilance agreements or national mandated reporting laws), as well as other sources such as cases reported in medical literature, play a critical role in providing the data necessary for pharmacovigilance to take place. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the national drug regulatory authority. (See Adverse event reporting below.)
Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with local, regional, national, or international laws and regulations. This includes ongoing collection of safety data after a product is approved for marketing.
Pharmacovigilance uses unique terminology. Below are most of the terms used within this article. They are particular to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well.
The European Medicines Agency defines terms in its Guideline on good pharmacovigilance practices (GVP):
The activity that is most commonly associated with pharmacovigilance (PV), and which consumes a significant number of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entry, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports from healthcare professionals or patients (or other intermediaries); solicited reports from patient support programs; reports from clinical or post-marketing studies; reports from literature sources; reports from the media (including social media and websites); and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The following are several facets of AE reporting:
One of the fundamental principles of adverse event reporting is the determination of what constitutes an individual case safety report. During the triage phase of a potential adverse event report, it is important to determine if the "four elements" of a valid individual case safety report are present: (1) an identifiable patient, (2) an identifiable reporter, (3) a suspect drug, and (4) an adverse event.
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Pharmacovigilance
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products.
The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended. That definition includes lack of efficacy: that means that the doses normally used for prevention, diagnosis, or treatment of a disease—or, especially in the case of device, for the modification of physiological disorder function. In 2010, the European Union expanded PV to include medication errors such as overdose, misuse, and abuse of a drug as well as drug exposure during pregnancy and breastfeeding. These are monitored even in the absence of an adverse event, because they may result in an adverse drug reaction. The US FDA has long considered such criteria to conform to reportable and collectible PV standards.
Patient and healthcare provider reports (via pharmacovigilance agreements or national mandated reporting laws), as well as other sources such as cases reported in medical literature, play a critical role in providing the data necessary for pharmacovigilance to take place. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the national drug regulatory authority. (See Adverse event reporting below.)
Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with local, regional, national, or international laws and regulations. This includes ongoing collection of safety data after a product is approved for marketing.
Pharmacovigilance uses unique terminology. Below are most of the terms used within this article. They are particular to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well.
The European Medicines Agency defines terms in its Guideline on good pharmacovigilance practices (GVP):
The activity that is most commonly associated with pharmacovigilance (PV), and which consumes a significant number of resources for drug regulatory authorities (or similar government agencies) and drug safety departments in pharmaceutical companies, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entry, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports from healthcare professionals or patients (or other intermediaries); solicited reports from patient support programs; reports from clinical or post-marketing studies; reports from literature sources; reports from the media (including social media and websites); and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing the risk-benefit profile of a given drug. The following are several facets of AE reporting:
One of the fundamental principles of adverse event reporting is the determination of what constitutes an individual case safety report. During the triage phase of a potential adverse event report, it is important to determine if the "four elements" of a valid individual case safety report are present: (1) an identifiable patient, (2) an identifiable reporter, (3) a suspect drug, and (4) an adverse event.