Pharmacovigilance (PV) is the pharmacological Pharmacology is the study of drug action. More specifically it is the study of the interactions that occur between a living organism and exogenous chemicals that alter normal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals. The field encompasses drug composition and properties, interactions, science Science refers to any systematic knowledge-base or prescriptive practice that is capable of resulting in a prediction or predictable type of outcome. In this sense, science may refer to a highly skilled technique or practice relating to the detection, assessment, understanding and prevention of adverse effects In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect, and may result from an unsuitable or incorrect dosage or procedure, which could be due to medical, particularly long term and short term side effects of medicines Medicine is the art and science of healing. It encompasses a range of health care practices evolved to maintain and restore health by the prevention and treatment of illness.[1] Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications A pharmaceutical drug, also referred to as medicine or medicament, can be loosely defined as any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Other synonyms include pharmacotherapy, pharmacotherapeutics, and drug treatment, biological products, herbalism Herbalism is a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Herbalism is also known as botanical medicine, medical herbalism, herbal medicine, herbology, and phytotherapy. The scope of herbal medicine is sometimes extended to include fungal and bee products, as well as minerals, shells and certain and traditional medicines Traditional medicine comprises medical knowledge systems that developed over centuries within various societies before the era of modern medicine. Practices known as traditional medicines include herbal, Ayurvedic, Unani, Ancient Iranian, Siddha, Islamic and traditional Chinese medicine, acupuncture, Muti, Ifá, and other medical knowledge and with a view to:
- identifying new information about hazards associated with medicines
- preventing harm to patients.
The etymological For languages with a long written history, etymologists make use of texts in these languages, and texts about the languages, to gather knowledge about how words were used at earlier stages, and when they entered the languages in question. Etymologists also apply the methods of comparative linguistics to reconstruct information about languages that roots are: pharmakon (Greek), “drug;” and vigilare (Latin), “to keep awake or alert, to keep watch.”
Pharmacovigilance is particularly concerned with adverse drug reactions An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dose. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as, or ADRs, which are officially described as: "A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function."[2]
Pharmacovigilance is gaining importance for doctors A physician, medical practitioner, doctor of medicine, doctor of osteopathic medicine, or medical doctor practices medicine, and is concerned with maintaining or restoring human health through the study, diagnosis, and treatment of disease and injury. This is accomplished through a detailed knowledge of anatomy, physiology, diseases and treatment and scientists as the number of stories in the mass media Mass media is a term used to denote a section of the media specifically designed to reach a very large audience such as the population of a nation state. It was coined in the 1920s with the advent of nationwide radio networks, mass-circulation newspapers and magazines, although mass media were present centuries before the term became common. The of drug recalls increases.[citation needed]
Because clinical trials involve several thousand patients at most; less common side effects and ADRs are often unknown at the time a drug enters the market. Even very severe ADRs, such as liver damage, are often undetected because study populations are small. Postmarketing pharmacovigilance uses tools such as data mining Data mining is the process of extracting hidden patterns from data. As more data is gathered, with the amount of data doubling every three years, data mining is becoming an increasingly important tool to transform this data into information. It is commonly used in a wide range of profiling practices, such as marketing, surveillance, fraud and investigation of case reports to identify the relationships between drugs and ADRs.
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Challenges in Ensuring Drug Safety
