In medicine Medicine is the science and art of healing. It encompasses a range of health care practices evolved to maintain and restore health by the prevention and treatment of illness. Before scientific medicine, healing arts were practised in accordance with alchemical treatments and ritual practices that developed out of religious and cultural traditions, an adverse effect is a harmful and undesired effect resulting from a medication A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease or other intervention such as surgery Surgery is a medical specialty that uses operative manual and instrumental techniques on a patient to investigate and/or treat a pathological condition such as disease or injury, to help improve bodily function or appearance, and sometimes for religious reasons. An act of performing surgery may be called a surgical procedure, operation, or simply. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect A therapeutic effect is a consequence of a medical treatment of any kind, the results of which are judged to be desirable and beneficial. This is true whether the result was expected, unexpected, or even an unintended consequence of the treatment. An adverse effect, on the other hand, is a harmful and undesired effect, and may result from an unsuitable or incorrect dosage A dose is a quantity of something that may impact an organism biologically; the greater the quantity, the larger the dose. In nutrition, the term is usually applied to how much of a specific nutrient is in a person's diet or in a particular food, meal, or dietary supplement. In medicine, the term is usually applied to the quantity of a drug or or procedure, which could be due to medical error Medical error is an inaccurate or incomplete diagnosis and/or treatment of a disease; injury; syndrome; behavior; infection or other ailment. Adverse effects are sometimes referred to as "iatrogenic The terms iatrogenesis and iatrogenic artifact refer to inadvertent adverse effects or complications caused by or resulting from medical treatment or advice. In addition to harmful consequences of actions by physicians, iatrogenesis can also refer to actions by other healthcare professionals, such as psychologists, therapists, pharmacists, nurses," because they are generated by a physician A physician—also known as doctor of medicine, medical doctor, or simply doctor—practices the ancient profession of medicine, which is concerned with maintaining or restoring human health through the study, diagnosis, and treatment of disease or injury. This properly requires both a detailed knowledge of the academic disciplines underlying/treatment. Some adverse effects only occur only when starting, increasing or discontinuing a treatment. Using a drug or other medical intervention which is contraindicated A contraindication is a condition or factor that speaks against a certain measure. It is mostly used in medicine, with regard to factors that increase the risks involved in using a particular drug, carrying out a medical procedure, or engaging in a particular activity may increase the risk Risk concerns the deviation of one or more results of one or more future events from their expected value. Technically, the value of those results may be positive or negative. However, general usage tends to focus only on potential harm that may arise from a future event, which may accrue either from incurring a cost or by failing to attain some of adverse effects. Adverse effects may cause medical complications Complication, in medicine, is an unfavorable evolution of a disease, a health condition or a medical treatment. The disease can become worse in its severity or show a higher number of signs, symptoms or new pathological changes, become widespread throughout the body or affect other organ systems. A medical treatment, such as drugs or surgery may of a disease A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal disfunctions, such as autoimmune diseases or procedure and negatively affect its prognosis Prognosis is a medical term to describe the likely outcome of an illness. When applied to large populations, prognostic estimates can be very accurate: for example the statement "45% of patients with severe septic shock will die within 28 days" can be made with some confidence, because previous research found that this proportion of. They may also lead to non-compliance Compliance is a medical term that means the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication, or drug compliance, but may also mean use of medical appliances such as compression stockings, chronic wound care, self-directed physiotherapy exercises, or attending counseling or other courses of therapy with a treatment regimen.
The harmful outcome is usually indicated by some result such as morbidity A disease is an abnormal condition affecting the body of an organism. It is often construed to be a medical condition associated with specific symptoms and signs. It may be caused by external factors, such as infectious disease, or it may be caused by internal disfunctions, such as autoimmune diseases, mortality Death is the termination of the biological functions that define a living organism. The word refers both to a particular process and to the condition that results thereby. The nature of the latter has been for millennia a central concern of the world's religious traditions and of philosophical enquiry. Belief in some kind of afterlife or rebirth, alteration in body weight Although some people prefer the less-ambiguous term body mass, the term body weight is overwhelmingly used in daily English speech as well as in the contexts of biological and medical sciences to describe the mass of an organism's body. Body weight is measured in kilograms throughout the world, although in some countries people more often measure, levels of enzymes Enzymes are proteins that catalyze chemical reactions. In enzymatic reactions, the molecules at the beginning of the process are called substrates, and the enzyme converts them into different molecules, called the products. Almost all processes in a biological cell need enzymes to occur at significant rates. Since enzymes are selective for their, loss of function, or as a pathological In medicine, pathology is the study and diagnosis of disease. The related scientific study of disease processes is called "general pathology". Medical pathology is divided into two main branches, anatomical pathology and clinical pathology. Medical pathologists work through examination of organs, tissues, bodily fluids, and whole bodies change detected at the microscopic, macroscopic or physiological level. It may also be indicated by symptoms A symptom is a departure from normal function or feeling which is noticed by a patient, indicating the presence of disease or abnormality. A symptom is subjective, observed by the patient, and not measured reported by a patient. Adverse effects may cause a reversible or irreversible change, including an increase or decrease in the susceptibility of the individual to other chemicals, foods Food is any substance or material eaten to provide nutritional support for the body or for pleasure. It usually consists of plant or animal origin, that contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals, and is ingested and assimilated by an organism to produce energy, stimulate growth, and maintain life, or procedures, such as drug interactions A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect that neither produces on its own. Typically, interaction between drugs come to mind . However, interactions may also exist between drugs & foods (drug-food interactions), as well as.
In clinical trials, a distinction is made between adverse events (AEs) and serious adverse events (SAEs). Generally, any event which causes death, permanent damage, birth defects Congenital disorder involves defects in or damage to a developing fetus. It may be the result of genetic abnormalities, the intrauterine environment, errors of morphogenesis, or a chromosomal abnormality. The outcome of the disorder will further depend on complex interactions between the pre-natal deficit and the post-natal environment. Animal, or requires hospitalization A hospital, in the modern sense of the word, is an institution for health care providing patient treatment by specialized staff and equipment, and often, but not always providing for longer-term patient stays. Its historical meaning, until relatively recent times, was "a place of hospitality", for example the Chelsea Royal Hospital, is considered an SAE. [1] The results of these trials are often included in the labeling of the medication to provide information both for patients and the prescribing physicians.
Contents |
Reporting systems
In many countries, adverse effects are required by law to be reported, researched in clinical trials Clinical Trials are conducted to allow safety and efficacy data to be collected for health interventions . These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place and included into the patient information accompanying medical devices A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery[citation needed]. If applied to the body, the effect of the medical device is primarily physical, in contrast to pharmaceutical drugs, which exert a biochemical effect. Specific regional definitions of medical device vary slightly as and drugs A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage for sale to the public.
United Kingdom
The Yellow Card Scheme This article is about Human Medicines. For Veterinary Medicines, see the Suspected Adverse Reaction Surveillance Scheme is a United Kingdom The United Kingdom of Great Britain and Northern Ireland[note 7] is a sovereign state located off the northwestern coast of continental Europe. It is an island country, spanning an archipelago including Great Britain, the northeastern part of the island of Ireland, and many small islands. Northern Ireland is the only part of the UK with a land initiative run by the Medicines and Healthcare products Regulatory Agency (MHRA) The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe and the Commission on Human Medicines (CHM) The Committee on the Safety of Medicines was an independent advisory committee that for 40 years advised the UK Licensing Authority on the quality, efficacy and safety of medicines. It was replaced on 30 October 2005 by the Commission on Human Medicines which combines the functions of both the former committee and the Medicines Commission to gather information on adverse effects to medicines A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease. This includes all licensed medicines, from medicines issued on prescription A prescription medication is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription. Different jurisdictions have different definitions of what constitutes a prescription drug to medicines bought over the counter Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a health care professional, as compared 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 from a supermarket. The scheme also includes all herbal supplements 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 unlicensed medicines found in cosmetic treatments. Adverse drug reactions (ADRs) can be reported by a number of healthcare professionals including physicians A physician—also known as doctor of medicine, medical doctor, or simply doctor—practices the ancient profession of medicine, which is concerned with maintaining or restoring human health through the study, diagnosis, and treatment of disease or injury. This properly requires both a detailed knowledge of the academic disciplines underlying, pharmacists Pharmacists are health professionals who practice the science of pharmacy. In their traditional role, pharmacists typically take a request for medicines from a prescribing health care provider in the form of a medical prescription, evaluate the appropriateness of the prescription, dispense the medication to the patient and counsel them on the and nurses A nurse is a healthcare professional who, in collaboration with other members of a health care team, is responsible for: treatment, safety, and recovery of acutely or chronically ill individuals; health promotion and maintenance within families, communities and populations; and, treatment of life-threatening emergencies in a wide range of health, as well as patients A patient is any person who receives medical attention, care, or treatment. The person is most often ill or injured and in need of treatment by a physician or other health care professional, although one who is visiting a physician for a routine check-up may also be viewed as a patient. For further information see the Yellow Card Scheme website, or find copies of the Yellow Card in the appedices of a BNF The British National Formulary contains a wide spectrum of information on prescribing and pharmacology, among others indications, side effects and costs of the prescription of all medications available on the National Health Service. It is used by general practitioners and specialist practitioners, and by other prescribers (such as nurses,. To read reports from the UK Yellow Card Scheme you can download here.
United States
In the United States ^ b. English is the de facto language of American government and the sole language spoken at home by 80% of Americans age five and older. Spanish is the second most commonly spoken language several reporting systems have been built, such as the Vaccine Adverse Event Reporting System The Vaccine Adverse Event Reporting System is a United States program for vaccine safety, co-managed by the Centers for Disease Control and Prevention and the Food and Drug Administration (FDA). VAERS is a post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after administration (VAERS), the Manufacturer and User Facility Device Experience Database (MAUDE) and the Special Nutritionals Adverse Event Monitoring System. MedWatch is the main reporting center, operated by the Food and Drug Administration The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter.
Australia
In Australia For at least 40,000 years before European settlement in the late 18th century, Australia was inhabited by indigenous Australians, who belonged to one or more of the roughly 250 language groups. After sporadic visits by fishermen from the immediate north and discovery by Dutch explorers in 1606, Australia's eastern half was claimed by the British, adverse effect reporting is administered by the Adverse Drug Reactions Advisory Committee The Adverse Drug Reactions Advisory Committee or ADRAC is a subcommittee of the Australian Drug Evaluation Committee which monitors the safety of medicines in Australia. ADRAC evaluates reports from the Adverse Drug Reactions Unit of the Therapeutic Goods Administration (TGA), which administers the adverse drug reaction (ADR) reporting system in (ADRAC), a subcommittee of the Australian Drug Evaluation Committee The Australian Drug Evaluation Committee or ADEC, is a committee that provides independent scientific advice to the Australian Government regarding therapeutic drugs. The committee was originally formed in 1963 and more recently authorised under the Therapeutic Goods Act 1989 as part of the Therapeutic Goods Administration (TGA) (ADEC). Reporting is voluntary, and ADRAC requests healthcare professionals to report all adverse reactions to its current drugs of interest, and serious adverse reactions to any drug. ADRAC publishes the Australian Adverse Drug Reactions Bulletin every two months.The Government's Quality Use of Medicines The term Quality use of medicines is used by the Australian government as part of their policies on effective and correct uses of medicine and access to appropriate medicines program is tasked with acting on this reporting to reduce and minimize the number of preventable adverse effects each year.
Adverse effects of medical procedures
Surgery Surgery is a medical specialty that uses operative manual and instrumental techniques on a patient to investigate and/or treat a pathological condition such as disease or injury, to help improve bodily function or appearance, and sometimes for religious reasons. An act of performing surgery may be called a surgical procedure, operation, or simply may have a number of undesirable or harmful effects, such as infection An infection is the detrimental colonization of a host organism by a foreign species. In an infection, the infecting organism seeks to utilize the host's resources to multiply, usually at the expense of the host. The infecting organism, or pathogen, interferes with the normal functioning of the host and can lead to chronic wounds, gangrene, loss, hemorrhage Bleeding, technically known as hemorrhaging or haemorrhaging is the loss of blood or blood escape from the circulatory system. Bleeding can occur internally, where blood leaks from blood vessels inside the body or externally, either through a natural opening such as the vagina, mouth, nose, ear or anus, or through a break in the skin. The complete, inflammation, scarring, loss of function, changes in local blood flow, and so on. They can be reversible or irreversible, and a compromise must be found by the physician and the patient between the beneficial or life-saving consequences of surgery versus its adverse effects. For example, a limb may be lost to amputation in case of untreatable gangrene, but the patient's life is saved. Presently, one of the greatest advantages of minimally invasive surgery, such as laparoscopic surgery is the reduction of adverse effects.
Other non-surgical physical procedures such as high-intensity radiation therapy may cause burns and alterations in the skin. In general, these therapies try to avoid damage to healthy tissues while maximizing the therapeutic effect.
Vaccination may have adverse effects due to the nature of its biological preparation, sometimes using attenuated pathogens and toxins. Common adverse effects may be fever, malaise and local reactions in the vaccination site. Very rarely, there is a serious adverse effect, such as eczema vaccinatum, a severe, sometimes fatal complication which may result in persons who have eczema or atopic dermatitis.
Diagnostic procedures may also have adverse effects, depending much on whether they are invasive, non-invasive or minimally invasive. For example, allergic reactions to radiocontrast material often occur, and a colonoscopy may cause the perforation of the intestine wall.
Adverse effects of drugs
Main article: Adverse drug reactionAdverse effects can occur as a collateral or side effect of many interventions, but they are particularly important in pharmacology, due to its wider, and sometimes uncontrollable, use by way of self-medication. Thus, responsible drug use becomes an important issue here. Adverse effects, like therapeutic effects of drugs, are a function of dosage or drug levels at the target organs, so they may be avoided or decreased by means of careful and precise pharmacokinetics, the change of drug levels in the organism in function of time after administration.
Adverse effects may also be caused by drug interaction. This often occurs when patients fail to inform their physician and pharmacist of all the medications they are taking, including herbal and dietary supplements. The new medication may interact agonistically or antagonistically (potentiate or decrease the intended therapeutic effect). Significant morbidity and mortality is caused around the world because of this. Drug-drug and food-drug interactions may occur, and so-called "natural drugs" used in alternative medicine can have dangerous adverse effects. For example, extracts of St John's wort (Hypericum perforatum), a phytotherapic used for treating mild depression are known to cause an increase in the cytochrome P450 enzymes responsible for the metabolism and elimination of many drugs, so patients taking it are likely to experience a reduction in blood levels of drugs that they are taking for other purposes, such as cancer chemotherapeutic drugs, protease inhibitors for HIV and hormonal contraceptives.
The scientific field of activity associated with drug safety is increasingly government-regulated and is of major concern for the public as well as to drug manufacturers. The distinction between adverse and non-adverse effects is a major undertaking when a new drug is developed and tested before marketing it. This is done in toxicity studies to determine the non-adverse effect level (NOAEL). These studies are used to define the dosage to be used in human testing (phase I) as well as to calculate the maximum admissible daily intake. Imperfections in clinical trials, such as insufficient number of patients or short duration, sometimes lead to public health disasters such as those of fenfluramine (the so-called fen-phen episode), thalidomide and, more recently, of cerivastatin (Baycol, Lipobay) and rofecoxib (Vioxx), where drastic adverse effects were observed, like teratogenesis, pulmonary hypertension, stroke, heart disease, neuropathy, etc., and a significant number of deaths, causing the forced or voluntary withdrawal of the drug from the market.
Most drugs have a large list of non-severe or mild adverse effects which do not rule out the interruption of usage. These effects have widely variable incidence, according to individual sensitivity. They comprise nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.
Controversies
Sometimes, putative medical adverse effects are regarded as controversial and generate heated discussions in society and lawsuits against drug manufacturers. One example is the recent controversy as to whether autism was linked to the MMR vaccine (or by thiomersal, a mercury-based preservative used in some vaccines). No link has been found in several large studies and no change in the rate of autism has occurred when thimerosal was removed from vaccines a decade ago in Canada and Europe.
Another instance is the potential adverse effects of silicone breast implants, which lead to hundreds of thousands of litigations against manufacturers of gel-based implants, due to allegations of damage to the immune system which have not yet been conclusively proven.
Due to the exceedingly high impact on public health of widely used medications, such as hormonal contraception and hormone replacement therapy, which may affect millions of users, even marginal probabilities of adverse effects of a severe nature, such as breast cancer, have led to public outcry and changes in medical therapy, although its benefits largely surpassed the statistical risks.
Limitations of adverse effects reporting
In principle, medical professionals are required to report all adverse effects related to a specific form of therapy. In practice, it is at the discretion of the professional to determine whether a medical event is at all related to the therapy. For example, a leg fracture in a skiing accident in a patient who years before took antibiotics for pneumonia is not likely to get reported.
As a result, routine adverse effects reporting may often not include long-term and subtle effects that may ultimately be attributed to a therapy.
Part of the difficulty is identifying the source of a complaint. A headache in a patient taking medication for influenza may be the underlying disease and may be an adverse effect. In patients with end-stage cancer, death is a very likely outcome and whether the drug is the cause or a bystander is often difficult to discern. (1)
Examples of adverse effects associated with specific medications
- Abortion, miscarriage or uterine hemorrhage associated with misoprostol (Cytotec), a labor-inducing drug (this is a case where the adverse effect has been used legally and illegally for performing abortions)
- Addiction to many sedatives and analgesics, such as diazepam, morphine, etc.
- Birth defects associated with Thalidomide and isotretinoin (Accutane)
- Bleeding of the intestine associated with aspirin therapy
- Cardiovascular disease associated with COX-2 inhibitors (i.e. Vioxx)
- Deafness and kidney failure associated with gentamicin (an antibiotic)
- Death, following sedation in children using propofol (Diprivan)
- Dementia associated with Coronary artery bypass surgery
- Depression or hepatic injury caused by interferon
- Diabetes caused by atypical antipsychotic medications (neuroleptic psychiatric drugs)
- Diarrhea caused by the use of orlistat (Xenical)
- Erectile dysfunction associated with many drugs, such as antidepressants
- Fever associated with vaccination (in the past, imperfectly manufactured vaccines, such as Bacillus Calmette-Guérin (BCG) and poliomyelitis, have caused the very disease they intended to fight)
- Glaucoma associated with corticosteroid-based eye drops
- Hair loss and anemia may be caused by chemotherapy against cancer, leukemia, etc.
- Headache following spinal anaesthesia
- Hypertension in ephedrine users, which prompted FDA to remove the status of dietary supplement of ephedra extracts
- Insomnia caused by stimulants, methylphenidate (Ritalin), Adderall, etc.
- Lactic acidosis associated with the use of stavudine (Zerit, for anti-HIV therapy) or metformin (for diabetes)
- Liver damage from paracetamol
- Melasma and thrombosis associated with use of estrogen-containing hormonal contraception, such as the combined oral contraceptive pill
- Priapism associaded with the use of sildenafil
- Rhabdomyolysis associated with statins (anti-cholesterol drugs)
- Seizures caused by withdrawal from benzodiazepines
- Drowsiness or increase in appetite due to antihistamine use. Some antihistamines are used in sleep aids explicitly because they cause drowsiness.
- Stroke or heart attack associated with sildenafil (Viagra), when used with nitroglycerin
- Suicide, increased tendency associated to the use of fluoxetine and other selective serotonin reuptake inhibitor (SSRI) antidepressants
- Tardive dyskinesia associated with long-term use of metoclopramide and many antipsychotic medications
See also
- Biosafety
- Classification of Pharmaco-Therapeutic Referrals
- Complication (medicine)
- Consultant pharmacist
- Contraindication
- Drug interaction
- EudraVigilance
- Evidence-based medicine
- Food and Drug Administration (United States)
- Iatrogenesis
- List of withdrawn drugs
- Medical algorithm
- Medical error
- Medical prescription
- Nocebo
- Patient safety
- Perioperative mortality
- Pharmacotoxicology
- Pharmacovigilance
- Placebo
- Polypharmacy
- Responsible drug use
- Toxicology
References
External links
- Patient Safety Network - includes a glossary and articles on adverse effects, drug reactions, medical error, iatrogenesis, among others.
- Australian Adverse Drug Reactions Bulletin - published bimonthly
- Medication Errors -- from the U.S. Food and Drug Administration.
- Medical Product Safety Information - MedWatch lists safety alerts for drugs, biologics, devices and dietary supplements, recalls, market withdrawals, public health advisories and links
- Medical Devices Safety National Library of Medicine (Medline Plus, useful lists of conventional drug and medical device articles and websites)
- When Medicine Hurts Instead of Helps - June 1998 report by the Alliance for Aging Research.
Categories: Medical terms | Pharmacology | Patient safety | Effects of external causes
Personal tools
- New features
- Log in / create account
Namespaces
- Article
- Discussion
Variants
Views
- Read
- Edit
- View history
Actions
Navigation
- Main page
- Contents
- Featured content
- Current events
- Random article
Interaction
- About Wikipedia
- Community portal
- Recent changes
- Contact Wikipedia
- Donate to Wikipedia
- Help
Toolbox
- What links here
- Related changes
- Upload file
- Special pages
- Permanent link
- Cite this page
Print/export
- Create a book
- Download as PDF
- Printable version
Languages
- Català
- Dansk
- Deutsch
- Español
- Euskara
- فارسی
- Français
- Galego
- עברית
- Nederlands
- 日本語
- Norsk (bokmål)
- Polski
- Português
- Simple English
- Slovenščina
- Suomi
- Svenska
- Türkçe
- 中文
- Italiano