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Adverse Event
In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medication directly caused the problem. These events can include any unfavorable symptoms, signs, or medical conditions that appear during medical treatment, regardless of whether they are definitively linked to the specific medication being studied. AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceuticals
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in many ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the medical prescription) from over-the-counter drugs (those that consumers can order for themselves). Medicines may be classified by mode of action, route of administration, biological system affected, or therapeutic effects. The World Health Organization keeps a list of essential medicines. Drug discovery and drug development are complex and expensive endeavors undertaken by pharmaceutical companies, academic scientists, and governments. As a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Kaiser Family Foundation
KFF, which was formerly known as The Kaiser Family Foundation or The Henry J. Kaiser Family Foundation, is an American non-profit organization, non-profit organization, headquartered in San Francisco, San Francisco, California. It prefers KFF, which is its business operating name, to reduce confusion because it is not affiliated with Kaiser Permanente and it is no longer a Foundation (nonprofit), foundation. KFF states that it is a Nonpartisanism, non-partisan organization focused on health policy. It conducts its own research, polling, journalism, and specialized public health information campaigns. Its website has been praised for having the "most up-to-date and accurate information on health policy" and as a "must-read for healthcare devotees." Current activities Policy analysis and polling KFF publishes analysis, polling and journalism about health-care issues, and states that much of its work especially concerns persons with low income or those who are otherwise especially ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Event Reporting System
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery (such as need for retraining to prevent prescribing errors). The system interacts with several related systems including MedWatch and the Vaccine Adverse Event Reporting System. FAERS replaced legacy AERS system in Sep 2012. Background Reporting of adverse events from the point of care is voluntary in the United States. The FDA receives some adverse event and medica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vaccine-associated Enhanced Respiratory Disease
Vaccine-associated enhanced respiratory disease (VAERD), or simply enhanced respiratory disease (ERD), is an adverse event where an exacerbated course of respiratory disease occurs with higher incidence in the vaccinated population than in the control group. It is a barrier against vaccine development that can lead to its failure. Immunologically, VAERD is characterized with an exaggerated Th2 response and eosinophilic pulmonary infiltrations. It may result from antibody-mediated complement activation followed by weak neutralization. Historical instances of the phenomenon were seen in vaccine candidates for respiratory syncytial virus (RSV), SARS-CoV, Middle East Respiratory Syndrome (MERS), and some influenza strains. Thus, COVID-19 vaccine clinical research involved monitoring for VAERD because the vaccine target, SARS-CoV-2, belongs to the same viral subfamily as SARS-CoV and MERS. The effect was not shown in phase III clinical trials for Tozinameran or for the Mod ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials Directive
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use) is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure. The Member States of the European Union had to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions necessary to comply with this Directive. The Member States had to apply these provisions at the latest with effect from 1 May 2004. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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: (Greek for drug) and (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 adve ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Antibody-dependent Enhancement
Antibody-dependent enhancement (ADE), sometimes less precisely called immune enhancement or disease enhancement, is a phenomenon in which binding of a virus to suboptimal antibodies enhances its entry into host cells, followed by its replication. The suboptimal antibodies can result from natural infection or from vaccination. ADE may cause enhanced respiratory disease, but is not limited to respiratory disease. It has been observed in HIV, RSV, and Dengue virus and is monitored for in vaccine development. Technical description In ADE, antiviral antibodies promote viral infection of target immune cells by exploiting the phagocytic FcγR or complement pathway. After interaction with a virus, the antibodies bind Fc receptors (FcR) expressed on certain immune cells or complement proteins. FcγRs bind antibodies via their fragment crystallizable region (Fc). The process of phagocytosis is accompanied by virus degradation, but if the virus is not neutralized (either due to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Outcome Pathway
An adverse outcome pathway (AOP) is structured representation of biological events leading to adverse effects and is considered relevant to risk assessment. The AOP links in a linear way existing knowledge along one or more series of causally connected key events (KE) between two points — a molecular initiating event (MIE) and an adverse outcome (AO) that occur at a level of biological organization relevant to risk assessment. The linkage between the events is described by key event relationships (KER) that describe the causal relationships between the key events. AOPs are important for expanding the use of mechanistic toxicological data for risk assessment and regulatory applications with recent applications in further disciplines such as climate science. Background In 2012, the Organisation for Economic Co-operation and Development (OECD) launched a new programme on the development of adverse outcome pathways. A guidance document describes in detail how AOPs are to be d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Vaccine Event
A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event believed to have been caused by vaccination. The World Health Organization (WHO) refers to Adverse Events Following Immunization (AEFI). AEFIs can be related to the vaccine itself (product or quality defects), to the vaccination process (administration error or stress related reactions) or can occur independently from vaccination (coincidental). Most vaccine adverse events are mild. Serious injuries and deaths caused by vaccines are very rare, and the idea that severe events are common has been classed as a "common misconception about immunization" by the WHO. Some claimed vaccine injuries are not, in fact, caused by vaccines; for example, there is a subculture of advocates who attribute their children's autism to vaccine injury, despite the fact that vaccines do not cause autism. Claims of vaccine injuries appeared in litigation in the United States in the latter part of the 20th cent ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Drug Reaction
An adverse drug reaction (ADR) is a harmful, unintended result caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or may result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as ''pharmacovigilance''. An adverse event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. An ADR is a special type of AE in which a causative relationship can be shown. ADRs are only one type of medication-related harm. Another type of medication-related harm type includes not taking prescribed medications, known as non-adherence. Non-adherence to medications can lead to death and other negative outcomes. Adverse drug reactions require the use of a medication. Classific ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Effect
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. The term complication is similar to adverse effect, but the latter is typically used in pharmacological contexts, or when the negative effect is expected or common. If the negative effect results from an unsuitable or incorrect dosage or procedure, this is called a medical error and not an adverse effect. 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 wi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Monitoring Committee
A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. Need for a DMC Many randomized clinical trials are double-blind – no one involved with the trial knows what treatment is to be given to each trial participant. Blinding includes the participant, their doctor, and even the study personnel at the company or organization sponsoring the trial. Blinding is breached and true assignments disclosed only after the trial database is finalized and locked against edits (i.e., until it is read-only for statistical analysis). On rare occasions a single participant's treating physician may be unblinded to the participant's study treatment assignment if that information is critical to the participant's immediate health care. Clinical trials may test an unknown procedure or may continue for years, and there is justifiable ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
