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Pharmacovigilance (PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.〔Source: The Importance of Pharmacovigilance, WHO 2002〕 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, or ADRs, 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). 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. Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), 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 fact, 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. ==Terms commonly used in drug safety== Pharmacovigilance has its own unique terminology that is important to understand. Most of the following terms are used within this article and are peculiar to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well. * ''Adverse Drug Reaction '' is a side effect (non intended reaction to the drug) occurring with a drug where a positive (direct) causal relationship between the event and the drug is thought, or has been proven, to exist. * ''Adverse event (AE)'' is a side effect occurring with a drug. By definition, the causal relationship between the AE and the drug is unknown. * ''Benefits'' are commonly expressed as the proven therapeutic good of a product but should also include the patient’s subjective assessment of its effects. * ''Causal relationship'' is said to exist when a drug is thought to have caused or contributed to the occurrence of an adverse drug reaction. * ''Clinical trial'' (or study) refers to an organised program to determine the safety and/or efficacy of a drug (or drugs) in patients. The design of a clinical trial will depend on the drug and the phase of its development. * ''Control group'' is a group (or cohort) of individual patients that is used as a standard of comparison within a clinical trial. The control group may be taking a placebo (where no active drug is given) or where a different active drug is given as a comparator. * ''Dechallenge'' and ''Rechallenge'' refer to a drug being stopped and restarted in a patient, respectively. A positive dechallenge has occurred, for example, when an adverse event abates or resolves completely following the drug's discontinuation. A positive rechallenge has occurred when the adverse event re-occurs after the drug is restarted. Dechallenge and rechallenge play an important role in determining whether a causal relationship between an event and a drug exists. * ''Effectiveness'' is the extent to which a drug works under real world circumstances, i.e., clinical practice. * ''Efficacy'' is the extent to which a drug works under ideal circumstances, i.e., in clinical trials. * ''Event'' refers to an adverse event (AE). * ''Harm'' is the nature and extent of the actual damage that could be or has been caused. * ''Implied causality'' refers to spontaneously reported AE cases where the causality is always presumed to be positive unless the reporter states otherwise. * ''Individual Case Study Report (ICSR)'' is an adverse event report for an individual patient. * ''Life-threatening'' refers to an adverse event that places a patient at the ''immediate'' risk of death. * ''Phase'' refers to the four phases of development: I - small safety trials early on in a drug's development; II - medium-sized trials for both safety and efficacy; III - large trials, which includes key (or so-called "pivotal") trials; IV - large, post-marketing trials, typically for safety reasons. There are also intermediate phases designated by an "a" or "b", e.g. Phase IIb. * ''Risk'' is the probability of harm being caused, usually expressed as a percent or ratio of the treated population. * ''Risk factor'' is an attribute of a patient that may predispose, or increase the risk, of that patient developing an event that may or may not be drug-related. For instance, obesity is considered a risk factor for a number of different diseases and, potentially, ADRs. Others would be high blood pressure, diabetes, possessing a specific mutated gene, for example, mutations in the BRCA1 and BRCA2 genes increase propensity to develop breast cancer. * ''Signal'' is a new safety finding within safety data that requires further investigation. There are three categories of signals: ''confirmed signals'' where the data indicate that there is a causal relationship between the drug and the AE; ''refuted (or false) signals'' where after investigation the data indicate that no causal relationship exists; and ''unconfirmed signals'' which require further investigation (more data) such as the conducting of a post-marketing trial to study the issue. * ''Temporal relationship'' is said to exist when an adverse event occurs when a patient is taking a given drug. Although a temporal relationship is absolutely necessary in order to establish a causal relationship between the drug and the AE, a temporal relationship does not necessarily in and of itself prove that the event was caused by the drug. * ''Triage'' refers to the process of placing a potential adverse event report into one of three categories: 1) non-serious case; 2) serious case; or 3) no case (minimum criteria for an AE case are not fulfilled). 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Pharmacovigilance」の詳細全文を読む スポンサード リンク
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