Drug safety; subdiscipline of pharmacy relating to prevention of adverse effects of drugs
"Drug safety" redirects here. For the peer-reviewed journal, see Drug Safety.
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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.[1]: 7 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, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation).[2] Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.[3]
Information received from patients and healthcare providers via pharmacovigilance agreements, as well as other sources such as the medical literature, plays 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 local 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 worldwide laws, regulations, and guidance.[4]
^The Importance of Pharmacovigilance (Report). World Health Organization. 2002. ISBN 9241590157. Retrieved December 31, 2020.
^"DIRECTIVE 2010/84/EU, Article 101" (PDF). ec.europa.eu. Retrieved October 26, 2015.
^"International Drug Monitoring : The Role of National Centers" (PDF). Who-umc.org. Retrieved February 27, 2015.
^"Preparing for a Safety Inspection" (PDF). Steve Jolley. 2011. Archived from the original (PDF) on January 9, 2016. Retrieved January 4, 2016.
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring...
In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company...
the Pharmacovigilance Risk Assessment Committee (PRAC) has come into function in 2012 with the implementation of the new EU pharmacovigilance legislation...
The International Society of Pharmacovigilance (ISoP), previously the European Society of Pharmacovigilance (ESOP), is an international non-profit scientific...
The Pharmacovigilance Programme of India (PvPI) is an Indian government organization which identifies and responds to drug safety problems. Its activities...
Veterinary pharmacovigilance in the United Kingdom is overseen by the Veterinary Medicines Directorate (VMD). The Pharmacovigilance Unit at the VMD monitors...
Atosiban, sold under the brand name Tractocile among others, is an inhibitor of the hormones oxytocin and vasopressin. It is used as an intravenous medication...
assessing and communicating information from member countries' national pharmacovigilance centres in regard to the benefits, harm, effectiveness and risks of...
poisonous. The Indian Journal of Pharmacology notes: According to WHO, "Pharmacovigilance activities are done to monitor detection, assessment, understanding...
commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real world evidence. CROs are designed to...
of misuse or dependence with etifoxine were identified in a French pharmacovigilance survey, which is also in contrast to benzodiazepines. Etifoxine has...
that are altogether unique to pharmacoepidemiology, e.g., pharmacovigilance. Pharmacovigilance is a type of continual monitoring of unwanted effects and...
deaths from drug overdose and intoxication Adverse drug reaction Pharmacovigilance James Montgomery (June 21, 2007). "Hawthorne Heights Guitarist Casey...
(2004). "A Case Report on Nimesulide and its Relation with Angina". J Pharmacovigilance Drug Safety. 1: 19–21. Khan RA, Rahman SZ (2004). "Nimesulide Induced...
Solutions India, a provider of outsourced safety management solutions (pharmacovigilance) with approximately 1500 employees. February 2016: Parexel acquires...
January 2022. Retrieved 25 March 2022. Urmila, T.; Supriya, B. (2008). "Pharmacovigilance of ayurvedic medicines in India". Indian Journal of Pharmacology....
Syndrome". medsafe.govt.nz (Prescriber Update 28(1) ed.). New Zealand Pharmacovigilance Centre, Dunedin: New Zealand Medicines and Medical Devices Safety...
Medical College, Aligarh, Elected Secretary of IAOMC and Society of Pharmacovigilance, India (SoPI). Syed Ziaur Rahman's father Hakim Syed Zillur Rahman...
domperidone-containing medicines. It also approved earlier published suggestions by Pharmacovigilance Risk Assessment Committee (PRAC) to use domperidone only for treating...
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