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Adverse Effects
In medicine, an adverse effect is an undesired harmful 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. If it results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not a complication. Adverse effects are sometimes referred to as "iatrogenic" because they are generated by a physician/treatment. Some adverse effects occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated may increase the risk of adverse effects. Adverse effects may cause complications of a disease or procedure and negatively affect its prognosis. They may also lead to non-compliance with a treatment regimen
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International Statistical Classification Of Diseases And Related Health Problems
The International Classification of Diseases (ICD) is the international "standard diagnostic tool for epidemiology, health management and clinical purposes". Its full official name is International Statistical Classification of Diseases and Related Health Problems.[1] The ICD is maintained by the World Health Organization
World Health Organization
(WHO), the directing and coordinating authority for health within the United Nations System.[2] The ICD is designed as a health care classification system, providing a system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. This system is designed to map health conditions to corresponding generic categories together with specific variations, assigning for these a designated code, up to six characters long
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Committee On Safety Of Medicines
The Committee on Safety of Medicines (CSM) was an independent advisory committee that advised the UK Licensing Authority on the quality, efficacy and safety of medicines. Following the thalidomide tragedy of 1957 to 1961, in 1963 the government asked Sir Derrick Dunlop to set up a committee to investigate the control and introduction of new medicines in the United Kingdom. In June 1963 the Committee on Safety of Drugs (CSD) was established. As a result of the subsequent report to the Department of Health, which reinforced the need for specially trained doctors in the pharmaceutical industry and academic departments of medicine, Dunlop became the first chairman of the Committee
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Serious Adverse Event
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any doseresults in death, is life-threatening requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.[1]The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.[2] Adverse events are further defined as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”[2]Contents1 Research 2 Related Terms 3 Footnotes 4 See also 5 External
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Congenital Disorder
A birth defect, also known as a congenital disorder, is a condition present at birth regardless of its cause.[3] Birth
Birth
defects may result in disabilities that may be physical, intellectual, or developmental.[3] The disabilities can range from mild to severe.[7] Birth
Birth
defects are divided into two main types: structural disorders in which there are problems with t
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Hospital
A hospital is a health care institution providing patient treatment with specialized medical and nursing staff and medical equipment.[1] The best-known type of hospital is the general hospital, which typically has an emergency department to treat urgent health problems ranging from fire and accident victims to a heart attack. A district hospital typically is the major health care facility in its region, with large numbers of beds for intensive care and additional beds for patients who need long-term care. Specialised hospitals include trauma centres, rehabilitation hospitals, children's hospitals, seniors' (geriatric) hospitals, and hospitals for dealing with specific medical needs such as psychiatric treatment (see psychiatric hospital) and certain disease categories. Specialised hospitals can help reduce health care costs compared to general hospitals.[2] A teaching hospital combines assistance to people with teaching to medical students and nurses
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Medical Device
A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of:Diagnosis, prevention, monitoring, treatment, or alleviation of disease; Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap; Investigation, replacement, or modification of the anatomy or of a physiological process; Control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such meansMedical devices vary according to their intended use and indications. Examples range from simple devices such as tongue depressors, medical thermometers, and
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Drug
A drug is any substance (other than food that provides nutritional support) that, when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue causes a temporary physiological (and often psychological) change in the body.[2][3] In pharmacology, a pharmaceutical drug, also called a medication or medicine, is a chemical substance used to treat, cure, prevent, or diagnose a disease or to promote well-being.[2] Traditionally drugs were obtained through extraction from medicinal plants, but more recently also by organic synthesis.[4] Pharmaceutical drugs may be used for a limited duration, or on a regular basis for chronic disorders.[5] Pharmaceutical drugs are often classified into drug classes—groups of related drugs that have similar chemical structures, the same mechanism of action (binding to the same biological target), a related mode of action, and that are used to treat the same disease.[6][verification needed][7] The Anatomical Therape
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Clinical Study Report
In medicine, a clinical study report (CSR) on a clinical trial is a very long and detailed document giving much detail about the methods and results of a trial
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Yellow Card Scheme
The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.[1] The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman. It is run by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM). Suspected ADRs are collected on all licensed medicines and vaccines, from those issued on prescription to medicines bought over the counter from a pharmacist or supermarket. The Scheme also includes all herbal preparations and unlicensed medicines
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United Kingdom
The United Kingdom
United Kingdom
of Great Britain
Great Britain
and Northern Ireland, commonly known as the United Kingdom
United Kingdom
(UK) or Britain, is a sovereign country in western Europe
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Medicines And Healthcare Products Regulatory Agency
The Medicines
Medicines
and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom
United Kingdom
which is responsible for ensuring that medicines and medical devices work and are acceptably safe. MHRA was formed in 2003 with the merger of the Medicines
Medicines
Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with MHRA identity being used solely for the regulatory centre within the group
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Prescription Drug
A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug. "Rx" (℞) is often used as a short form for prescription drug in North America- a contraction of the Latin word "recipe" (an imperative form of "recipere") meaning "take".[1] Prescription drugs
Prescription drugs
are often dispensed together with a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug. The use of prescription drugs has been increasing since the 1960s
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ICD-10
ICD-10 is the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD), a medical classification list by the World Health Organization
World Health Organization
(WHO). It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases.[1] Work on ICD-10 began in 1983 and was completed in 1992.[1] The code set in the base classification allows for more than 14,400 different codes,[citation needed] and permits the tracking of many new diagnoses compared to ICD-9)
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Over-the-counter Drug
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription from a healthcare professional,[1] as opposed to prescription drugs, which may only be sold to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.[2] The term over-the-counter may be somewhat counterintuitive, since, in many countries, these drugs are often placed on shelves in self-service areas of stores, like any other packaged products.[1] In contrast, prescription drugs are almost always passed over a counter from the pharmacist to the customer
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Pharmacist
Pharmacists, also known as chemists (Commonwealth English) or druggists (North American and, archaically, Commonwealth English), are healthcare professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use. A pharmacist is a member of the health care team directly involved with patient care.[1][2] Pharmacists undergo university-level education to understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. This is mated to anatomy, physiology, and pathophysiology
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