1.
Pharmaceutical drug
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A pharmaceutical drug is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy is an important part of the field and relies on the science of pharmacology for continual advancement. Drugs are classified in various ways, one of the key divisions is by level of control, which distinguishes prescription drugs from over-the-counter drugs. Other ways to classify medicines are by mode of action, route of administration, biological system affected, an elaborate and widely used classification system is the Anatomical Therapeutic Chemical Classification System. 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. Governments generally regulate what drugs can be marketed, how drugs are marketed, controversies have arisen over drug pricing and disposal of used drugs. In the US, a drug is, A substance recognized by an official pharmacopoeia or formulary, a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance intended to affect the structure or any function of the body, a substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device. Pharmaceutical or a drug is classified on the basis of their origin, Drug from natural origin, Herbal or plant or mineral origin, some drug substances are of marine origin. Drug from chemical as well as origin, Derived from partial herbal and partial chemical synthesis Chemical. Drug derived from animal origin, For example, hormones, Drug derived from microbial origin, Antibiotics Drug derived by biotechnology genetic-engineering, hybridoma technique for example Drug derived from radioactive substances. An elaborate and widely used system is the Anatomical Therapeutic Chemical Classification System. The World Health Organization keeps a list of essential medicines, the main classes of painkillers are NSAIDs, opioids and Local anesthetics. For consciousness Some anesthetics include Benzodiazepines and Barbiturates, the main categories of drugs for musculoskeletal disorders are, NSAIDs, muscle relaxants, neuromuscular drugs, and anticholinesterases. Euthanasia is not permitted by law in countries, and consequently medicines will not be licensed for this use in those countries. Administration is the process by which a patient takes a medicine, there are three major categories of drug administration, enteral, parenteral, and other. It can be performed in various forms such as pills, tablets. There are many variations in the routes of administration, including intravenous and they can be administered all at once as a bolus, at frequent intervals or continuously
2.
Medical prescription
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A prescription is a health-care program implemented by a physician or other qualified health care practitioner in the form of instructions that govern the plan of care for an individual patient. The term often refers to a health care providers written authorization for a patient to purchase a prescription drug from a pharmacist, Prescriptions may be entered into an electronic medical record system and transmitted electronically to a pharmacy. Alternatively, a prescription may be handwritten on preprinted prescription forms that have been assembled into pads, in some cases, a prescription may be transmitted from the physician to the pharmacist orally by telephone, this practice may increase the risk of medical error. The content of a prescription includes the name and address of the prescribing provider, unique for each prescription is the name of the patient. In the United Kingdom and Ireland, the name and address must also be recorded. Each prescription is dated and some jurisdictions may place a limit on the prescription. Prescriptions also contain directions for the patient to follow when taking the drug and these directions are printed on the label of the pharmaceutical product. ℞ is a symbol meaning prescription and it is sometimes transliterated as Rx or just Rx. This symbol originated in medieval manuscripts as an abbreviation of the Late Latin verb recipe, medieval prescriptions invariably began with the command to take certain materials and compound them in specified ways. Folk theories about the origin of the symbol ℞ note its similarity to the Eye of Horus, or to the ancient symbol for Zeus or Jupiter, gods whose protection may have been sought in medical contexts. The word prescription, from pre- and script, refers to the fact that the prescription is an order that must be written down before a drug can be prepared. Those within the industry will often call prescriptions simply scripts, jurisdictions may adopt a statutory definition of prescription that applies as a term of art only to the operation of that statute, but the general legal definition of the word is this broad one. Many brand name drugs have cheaper generic drug substitutes that are therapeutically and biochemically equivalent, Prescriptions will also contain instructions on whether the prescriber will allow the pharmacist to substitute a generic version of the drug. This instruction is communicated in a number of ways, in some jurisdictions, the preprinted prescription contains two signature lines, one line has dispense as written printed underneath, the other line has substitution permitted underneath. Some have a preprinted box dispense as written for the prescriber to check off, in other jurisdictions they may use completely different languages, never mind a different formula of words. In some jurisdictions, it may be a requirement to include the age of child on the prescription. For pediatric prescriptions some advise the inclusion of the age of the if the patient is less than twelve. Adding the weight of the child is also helpful, Prescriptions often have a label box
3.
Over-the-counter drug
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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 physicians care. OTC drugs are regulated by active pharmaceutical ingredients, 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. The term over-the-counter may be somewhat counterintuitive, since, in many countries, in contrast, prescription drugs are almost always passed over a counter from the pharmacist to the customer. Some drugs may be classified as over-the-counter, but may only be dispensed by a pharmacist after an assessment of the patients needs or the provision of patient education. In many countries, a number of OTC drugs are available in establishments without a pharmacy, such as stores, supermarkets. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, as of 2011, around a third of older adults in the U. S. reportedly use OTC drugs. In Canada, there are four drug schedules, Schedule 1, Schedule 2, Do not require a prescription, but require an assessment by a pharmacist prior to sale. These drugs are kept in an area of the pharmacy where there is no public access, Schedule 3, Do not require a prescription, but must be kept in an area under the supervision of a pharmacist. These drugs are kept in an area of the outlet where self-selection is possible. Unscheduled, Do not require a prescription and may be sold in any retail outlet, all medications outside of Schedule 1 may be considered an OTC drug, as they do not require prescriptions for sale. While the National Association of Pharmacy Regulatory Authorities provides recommendations on the scheduling of drugs for sale in Canada, due to this, the exact drugs found in each schedule may vary from province to province. The drug can be on the shelves like any other product, examples are domperidone,400 mg ibuprofen up to 50 tablets and dextromethorphan. The drugs are usually on the shelves and the store sells items like toys, gadgets, perfumes. The drugs in this category have limited risk and addiction potential, examples are naproxen and diclofenac in small amounts, cinnarizine,400 mg ibuprofen up to 20 tablets and also 500 mg paracetamol up to 50 tablets. In the United States, the manufacture and sale of OTC substances is regulated by the Food, the FDA requires that all new drugs obtain a New Drug Application before entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective from this requirement. Thus, in the United States an OTC drug product is allowed to be marketed either pursuant to an FDA monograph, the Federal Trade Commission regulates advertising of OTC products. This is in contrast to prescription drug advertising, which is regulated by the FDA, the FDA requires that OTC products are labeled with an approved Drug Facts label to educate consumers about their medications
4.
Australia
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Australia, officially the Commonwealth of Australia, is a country comprising the mainland of the Australian continent, the island of Tasmania and numerous smaller islands. It is the worlds sixth-largest country by total area, the neighbouring countries are Papua New Guinea, Indonesia and East Timor to the north, the Solomon Islands and Vanuatu to the north-east, and New Zealand to the south-east. Australias capital is Canberra, and its largest urban area is Sydney, for about 50,000 years before the first British settlement in the late 18th century, Australia was inhabited by indigenous Australians, who spoke languages classifiable into roughly 250 groups. The population grew steadily in subsequent decades, and by the 1850s most of the continent had been explored, on 1 January 1901, the six colonies federated, forming the Commonwealth of Australia. Australia has since maintained a liberal democratic political system that functions as a federal parliamentary constitutional monarchy comprising six states. The population of 24 million is highly urbanised and heavily concentrated on the eastern seaboard, Australia has the worlds 13th-largest economy and ninth-highest per capita income. With the second-highest human development index globally, the country highly in quality of life, health, education, economic freedom. The name Australia is derived from the Latin Terra Australis a name used for putative lands in the southern hemisphere since ancient times, the Dutch adjectival form Australische was used in a Dutch book in Batavia in 1638, to refer to the newly discovered lands to the south. On 12 December 1817, Macquarie recommended to the Colonial Office that it be formally adopted, in 1824, the Admiralty agreed that the continent should be known officially as Australia. The first official published use of the term Australia came with the 1830 publication of The Australia Directory and these first inhabitants may have been ancestors of modern Indigenous Australians. The Torres Strait Islanders, ethnically Melanesian, were originally horticulturists, the northern coasts and waters of Australia were visited sporadically by fishermen from Maritime Southeast Asia. The first recorded European sighting of the Australian mainland, and the first recorded European landfall on the Australian continent, are attributed to the Dutch. The first ship and crew to chart the Australian coast and meet with Aboriginal people was the Duyfken captained by Dutch navigator, Willem Janszoon. He sighted the coast of Cape York Peninsula in early 1606, the Dutch charted the whole of the western and northern coastlines and named the island continent New Holland during the 17th century, but made no attempt at settlement. William Dampier, an English explorer and privateer, landed on the north-west coast of New Holland in 1688, in 1770, James Cook sailed along and mapped the east coast, which he named New South Wales and claimed for Great Britain. The first settlement led to the foundation of Sydney, and the exploration, a British settlement was established in Van Diemens Land, now known as Tasmania, in 1803, and it became a separate colony in 1825. The United Kingdom formally claimed the part of Western Australia in 1828. Separate colonies were carved from parts of New South Wales, South Australia in 1836, Victoria in 1851, the Northern Territory was founded in 1911 when it was excised from South Australia
5.
Health professional
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A health professional may operate within all branches of health care, including medicine, surgery, dentistry, midwifery, pharmacy, psychology, nursing or allied health professions. A health professional may also be a public/community health expert working for the good of the society. They often work in hospitals, healthcare centres, and other service points, but also in academic training, research. Some provide care and treatment services for patients in private homes, many countries have a large number of community health workers who work outside formal healthcare institutions. Managers of healthcare services, health technicians, and other assistive personnel. Healthcare practitioners are commonly grouped into health professions, within each field of expertise, practitioners are often classified according to skill level and skill specialization. In addition, unlicensed assistive personnel assist with providing health services as permitted. A mental health practitioner is a worker who offers services for the purpose of improving the mental health of individuals or treating mental illness. These health care providers often deal with the illnesses, disorders, conditions. The most significant difference across categories of health practitioners is education. A maternal and newborn health practitioner is a worker who deals with the care of women and their children before, during and after pregnancy. Such health practitioners include obstetricians, midwives, obstetrical nurses and many others, one of the main differences between these professions is in the training and authority to provide surgical services and other life-saving interventions. A surgical practitioner is a professional who specializes in the planning and delivery of a patients perioperative care, including during the anaesthetic, surgical. Medical diagnosis providers are health workers responsible for the process of determining which disease or condition explains a persons symptoms and it is most often referred to as diagnosis with the medical context being implicit. This usually involves a team of healthcare providers in various diagnostic units and these include radiographers, radiologists, medical laboratory scientists, pathologists, and related professionals. A dental care practitioner is a worker who provides care and treatment to promote. These include dentists and dental surgeons, dental assistants, dental auxiliaries, dental hygienists, dental nurses, dental technicians, dental therapists, and related professionals. Care and treatment for the foot, ankle, and lower leg may be delivered by podiatrists, pedorthists, foot health practitioners, podiatric medical assistants, podiatric nurse and others
6.
Pharmaceutical Benefits Scheme
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The PBS seeks to ensure that Australian residents have affordable and reliable access to a wide range of necessary medicines. The PBS has faced increased scrutiny as its cost has increased, the scheme assumes responsibility for the cost of drugs to patients in the community setting rather than while in hospital which is the responsibility of each state and territory. Together with Medicare the PBS is a key component of health care in Australia, the scheme was an extension of the similar Repatriation Pharmaceutical Benefits Scheme established in 1919 for Australian servicemen and women who had served in the Boer War and World War I. Though the High Court of Australia ruled that most of Chifleys health care plans were unconstitutional, initially, PBS covered approximately 140 lifesaving and disease-preventing drugs. Medicines on the PBS list were free to the consumer until 1960, by 2003 the number of drugs included under the scheme had expanded to 601 general products which were marketed as 2,602 different brands. The scheme was appealing to policy makers because it required no major capital works program, PBS is governed by the National Health Act 1953 and National Health Regulations 1960. Pharmaceutical benefits under PBS may only be supplied by pharmacists and medical practitioners approved under the Act, applications to list a drug on the PBS are administered by the Department of Health. Pharmaceutical benefits under the PBS are administered by Medicare Australia under the Health Insurance Act 1973, a benefit under PBS is only given on medications which are listed in the Pharmaceutical Benefits Schedule. The medication may be listed for use as an unrestricted benefit. When a PBS medication is dispensed by a pharmacist, the patient pays the patient contribution, the cost of a medication is negotiated between the government, through the Department of Health, and the supplier of the drug. The dispensed price includes the wholesalers markup, pharmacists markup, pharmacies purchase PBS-listed drugs from the wholesaler or supplier, and claim the difference between the dispensed price and the patient co-payment contribution from Medicare Australia. The PBS is separate to its counterpart, the Medical Benefits Schedule, when purchasing a medication under PBS the maximum price a patient pays is the patient contribution, which in 2016 is A$38.30 for general patients. Patient contributions are compulsory and cannot be discounted by pharmacies, the PBS safety net is separate from and in addition to the Medicare safety nets. Under the rule, a repeat prescription supplied within 20 days of a supply of the same medicine will not count towards the PBS safety net threshold. If the patient has reached the safety net threshold, they will be charged the normal patient contribution instead of the reduced safety net amount. In an effort to limit the cost of PBS, the Australian Government introduced Brand Premiums on medications where cheaper generic brands were available, the Brand Premium is usually the price difference between the innovator brand and the generic brand. The patient pays the Brand Premium in addition to the patient contribution if they decline to purchase the generic brand. The Brand Premium paid does not count toward either safety net threshold, the prescribers consent is always assumed to be granted unless brand substitution not permitted is indicated on the prescription
7.
Australian dollar
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Within Australia, it is almost always abbreviated with the dollar sign, with A$ or AU$ sometimes used to distinguish it from other dollar-denominated currencies. It is subdivided into 100 cents, in 2011, the Australian dollar was the fifth most traded currency in the world, accounting for 7. 6% of the worlds daily share. It trades in the foreign exchange markets behind the US dollar, the euro, the yen. The currency is referred to by foreign-exchange traders as the Aussie dollar. With pounds, shillings and pence to be replaced by decimal currency on 14 February 1966, in 1963, the Prime Minister, Sir Robert Menzies, a monarchist, wished to name the currency the royal. Other proposed names included more exotic suggestions such as the austral, the oz, the boomer, the roo, the kanga, the emu, the digger, the quid, the dinkum and the ming. Menzies influence resulted in the selection of the royal, and trial designs were prepared and printed by the Reserve Bank of Australia, the Treasurer, Harold Holt, announced the decision in Parliament on 5 June 1963. The royal would be subdivided into 100 cents, but the existing names shilling, florin, the name royal for the currency proved very unpopular, with Holt and his wife even receiving death threats. On 24 July Holt told the Cabinet the decision had been a terrible mistake, on 18 September Holt advised Parliament that the name was to be the dollar, of 100 cents. The Australian pound, introduced in 1910 and officially distinct in value from the pound sterling since devaluation in 1931, was replaced by the dollar on 14 February 1966. The rate of conversion for the new currency was two dollars per Australian pound, or ten Australian shillings per dollar. The exchange rate was pegged to the pound sterling at a rate of $1 =8 shillings, in 1967, Australia effectively left the sterling area, when the pound sterling was devalued against the US dollar and the Australian dollar did not follow. It maintained its peg to the US dollar at the rate of A$1 = US$1.12, on 27 September 2012, the Reserve Bank of Australia stated that they had ordered work on a project to upgrade the current banknotes. The upgraded banknotes will incorporate a number of new features so that they remain secure into the future, the first new banknotes were issued from the 1st of September 2016, with the remaining denominations to be issued in the coming years. In 1966, coins were introduced in denominations of 1,2,5,10,20 and 50 cents. The initial 50-cent coins contained high silver content and were withdrawn after a year after the value of the silver content was found to exceed the face value of the coins. One-dollar coins were introduced in 1984, followed by two-dollar coins in 1988, the one- and two-cent coins were discontinued in 1991 and withdrawn from circulation. In commemoration of the 40th anniversary of decimal currency, the 2006 mint proof and uncirculated sets included one-, in early 2013, Australias first triangular coin was introduced, to mark the 25th anniversary of the opening of Parliament House
8.
Off-label
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Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs can be used in off-label ways, off-label use is generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers, for example, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability, marketing of pharmaceuticals for off-label use is usually prohibited. For example, aspirin is generally indicated for a headache, when the drugs manufacturer has received a marketing approval from the government agency, then it is allowed to promote the drug for the specific, agreed-upon approved indications in that country. All legally approved indications are listed on the package insert or label. However, healthcare providers are not required to limit prescriptions or recommendations to the approved by their countrys drug regulatory agency. Prescribing a drug for a condition or use that has not been approved by the countrys drug regulatory agency is called off-label use. Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, among use of antipsychotic medications in the United States, a shift occurred from typical agents in 1995 to atypical agents by 2008. Atypical use has grown far beyond substitution for the now infrequently used typical agents, a 2009 study found that 62% of U. S. pediatric office visits from 2001-2004 included off-label prescribing, with younger children having a higher chance of receiving off-label prescriptions. Specialist physicians also prescribed off-label more frequently than general pediatricians, by some estimates, the number of clinical trials performed in children from 2002 -2012 exceeded that in the prior 50 years. In 2014, the American Academy of Pediatrics released a statement regarding off-label use of pharmaceuticals in children, the statement further advocates additional support and additional incentives for clinical testing of drugs in children, and publication of all results irrespective of positive outcome. A study published in 2006 found that use was the most common in anticonvulsants. This study also found that 73% of off-label use had little or no scientific support, a small market and the high risk of medicolegal action, as exemplified by the Bendectin case, may explain the reluctance to develop drugs for approval. Some drugs are used more frequently off-label than for their original, a 1997 survey of 200 cancer physicians by the American Enterprise Institute and the American Cancer Society found that 60% of them prescribed drugs off-label. In some cases, patients may perceive the efficacy of treatments for off-label purposes to be higher than for their indicated purpose, frequently, the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants to treat neuropathic pain, Drug manufacturers market drugs for off-label use in a range of ways. Marketing practices around off-label use have caused various of lawsuits and settlements about inappropriately promoting drugs, some of those lawsuits have ended granting the largest pharmaceutical settlements in the world
9.
United Kingdom
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The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom or Britain, is a sovereign country in western Europe. Lying off the north-western coast of the European mainland, the United Kingdom includes the island of Great Britain, Northern Ireland is the only part of the United Kingdom that shares a land border with another sovereign state—the Republic of Ireland. The Irish Sea lies between Great Britain and Ireland, with an area of 242,500 square kilometres, the United Kingdom is the 78th-largest sovereign state in the world and the 11th-largest in Europe. It is also the 21st-most populous country, with an estimated 65.1 million inhabitants, together, this makes it the fourth-most densely populated country in the European Union. The United Kingdom is a monarchy with a parliamentary system of governance. The monarch is Queen Elizabeth II, who has reigned since 6 February 1952, other major urban areas in the United Kingdom include the regions of Birmingham, Leeds, Glasgow, Liverpool and Manchester. The United Kingdom consists of four countries—England, Scotland, Wales, the last three have devolved administrations, each with varying powers, based in their capitals, Edinburgh, Cardiff and Belfast, respectively. The relationships among the countries of the UK have changed over time, Wales was annexed by the Kingdom of England under the Laws in Wales Acts 1535 and 1542. A treaty between England and Scotland resulted in 1707 in a unified Kingdom of Great Britain, which merged in 1801 with the Kingdom of Ireland to form the United Kingdom of Great Britain and Ireland. Five-sixths of Ireland seceded from the UK in 1922, leaving the present formulation of the United Kingdom of Great Britain, there are fourteen British Overseas Territories. These are the remnants of the British Empire which, at its height in the 1920s, British influence can be observed in the language, culture and legal systems of many of its former colonies. The United Kingdom is a country and has the worlds fifth-largest economy by nominal GDP. The UK is considered to have an economy and is categorised as very high in the Human Development Index. It was the worlds first industrialised country and the worlds foremost power during the 19th, the UK remains a great power with considerable economic, cultural, military, scientific and political influence internationally. It is a nuclear weapons state and its military expenditure ranks fourth or fifth in the world. The UK has been a permanent member of the United Nations Security Council since its first session in 1946 and it has been a leading member state of the EU and its predecessor, the European Economic Community, since 1973. However, on 23 June 2016, a referendum on the UKs membership of the EU resulted in a decision to leave. The Acts of Union 1800 united the Kingdom of Great Britain, Scotland, Wales and Northern Ireland have devolved self-government
10.
Physician
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Both the role of the physician and the meaning of the word itself vary around the world. Degrees and other qualifications vary widely, but there are common elements, such as medical ethics requiring that physicians show consideration, compassion. Around the world the term refers to a specialist in internal medicine or one of its many sub-specialties. This meaning of physician conveys a sense of expertise in treatment by drugs or medications and this term is at least nine hundred years old in English, physicians and surgeons were once members of separate professions, and traditionally were rivals. Henry VIII granted a charter to the London Royal College of Physicians in 1518 and it was not until 1540 that he granted the Company of Barber/Surgeons its separate charter. In the same year, the English monarch established the Regius Professorship of Physic at the University of Cambridge, newer universities would probably describe such an academic as a professor of internal medicine. Hence, in the 16th century, physic meant roughly what internal medicine does now, currently, a specialist physician in the United States may be described as an internist. Another term, hospitalist, was introduced in 1996, to describe US specialists in internal medicine who work largely or exclusively in hospitals, such hospitalists now make up about 19% of all US general internists, who are often called general physicians in Commonwealth countries. In such places, the more general English terms doctor or medical practitioner are prevalent, in Commonwealth countries, specialist pediatricians and geriatricians are also described as specialist physicians who have sub-specialized by age of patient rather than by organ system. Around the world, the term physician and surgeon is used to describe either a general practitioner or any medical practitioner irrespective of specialty. This usage still shows the meaning of physician and preserves the old difference between a physician, as a practitioner of physic, and a surgeon. The term may be used by state medical boards in the United States of America, in modern English, the term physician is used in two main ways, with relatively broad and narrow meanings respectively. This is the result of history and is often confusing and these meanings and variations are explained below. In the United States and Canada, the term physician describes all medical practitioners holding a professional medical degree, the American Medical Association, established in 1847, as well as the American Osteopathic Association, founded in 1897, both currently use the term physician to describe members. However, the American College of Physicians, established in 1915, does not, its title uses physician in its original sense. A physician trained in the United States has either a Doctor of Medicine degree, all boards of certification now require that physicians demonstrate, by examination, continuing mastery of the core knowledge and skills for a chosen specialty. Recertification varies by particular specialty between every seven and every ten years, graduates of osteopathic medical schools in the United States should not be confused with osteopaths, who are trained in the European and Commonwealth nations. Their training is similar to physical therapy and they are not licensed to prescribe medications or perform surgeries, also in the United States, the American Podiatric Medical Association defines podiatrists as physicians and surgeons that fall under the department of surgery in hospitals
11.
Dentist
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A dentist, also known in the U. S. as a dental surgeon, is a surgeon who specializes in dentistry—the diagnosis, prevention, and treatment of diseases and conditions of the oral cavity. The dentists supporting team aids in providing health services. The dental team includes dental assistants, dental hygienists, dental technicians, in China as well as France, the first people to perform dentistry were barbers. They have been categorized into 2 distinct groups, guild of barbers, the first group, the Guild of Barbers, was created to distinguish more educated and qualified dental surgeons from lay barbers. Guild barbers were trained to do complex surgeries, the second group, the lay barbers, were qualified to perform regular hygienic services such as shaving and tooth extraction as well as basic surgery. However, in 1400 France made decrees prohibiting lay barbers from practicing all types of surgery, in Germany as well as France from 1530 to 1575 publications completely devoted to dentistry were being published. Ambrose Pare, often known as the Father of Surgery, published his own work about the proper maintenance, ambrose Pare was a French barber surgeon who performed dental care for multiple French monarchs. He is often credited with having raised the status of barber surgeons, pierre Fauchard of France is often referred to as the father of modern dentistry for being the first to publish a scientific textbook on the techniques and practices of dentistry. Over time, trained dentists immigrated from Europe to the Americas to practice dentistry, newspapers were used at the time to advertise and promote dental services. In America from 1768-1770 the first application of dentistry to verify forensic cases was being pioneered, with the rise of dentists there was also the rise of new methods to improve the quality of dentistry. These new methods included the spinning wheel to rotate a drill, in the 1840s the worlds first dental school and national dental organization were established. Along with the first dental school came the establishment of the Doctor of Dental Surgery degree, in response to the rise in new dentists as well as dentistry techniques, the first dental practice act was established to regulate dentistry. In the United States, the First Dental Practice Act required dentists to pass each specific states medical board exam in order to practice dentistry in particular state. However, because the act was rarely enforced, some dentists did not obey the act. From 1846-1855 new dental techniques were being invented such as the use of anesthesia for surgery. The American Dental Association was established in 1859 after a meeting with 26 dentists, around 1867, the first university associated dental school was established, Harvard Dental School. Lucy Hobbs Taylor was the first woman to earn a dental degree, in the 1880s, tube toothpaste was created which replaced the original forms of powder or liquid toothpaste. New dental boards, such as the National Association of Dental Examiners, were created to establish standards, in 1887 the first dental laboratory was established, dental laborites are used to create dentures and crowns that are specific to each patient
12.
District nurse
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District Nurses work in the United Kingdoms National Health Service, managing care within the community and lead teams of community nurses and support workers. The role requires registered nurses to take a NMC approved specialist practitioner course, duties generally include visiting house-bound patients and providing advice and care such as palliative care, wound management, catheter and continence care and medication support. As well as treatment, a nurse can offer advice and support with health concerns. District Nurses can specialise in different areas such as palliative care, District Nurses, like all qualified nurses, are regulated by the Nursing and Midwifery Council. District nurses can also be known as community nurse specialists, in the UK, training as a district nurse requires registration as a nurse in the adult branch, and consolidation of pre registration nurse education. A degree or postgraduate course is then undertaken which is approved by the Nursing. Organised district nursing in England is considered to have begun in 1859, in 1858 Liverpool philanthropist William Rathbone employed a nurse, Mary Robinson, to take care of his wife at home during her final illness. After his wife’s death in 1859, he engaged Mary to go one of the poorest districts of the City to bring healthcare to people who had no means to pay for it. He spent the rest of his working to build up the service, with assistance from Florence Nightingale. District nursing on the Liverpool model soon sprang up in towns, cities and rural areas. In 1887 Queen Victoria’s Jubilee Institute for Nurses was founded, centralising training for nurses until nursing education became nationalised in 1968. The charity, which became the Queens Nursing Institute, continues to support community nurses to this day, the Institute always needed to raise funds and until the creation of the NHS in 1948, district nurses collected contributions from their patients. The District Nurse TV programme Call the Midwife, TV programme Visiting Nurse Association District Nursing 150 website by Queens Nursing Institute
13.
National Health Service
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The National Health Service is the name of the public health services of England, Scotland and Wales, and is commonly used to refer to those of Northern Ireland. They were established together as one of the social reforms following the Second World War on the founding principles of being comprehensive, universal. Today, each provides a range of health services, the vast majority of which are free for people ordinarily resident in the United Kingdom. Taken together, the four National Health Services in 2015-16 employed around 1.6 million people with a budget of £136.7 billion. For non-residents, the NHS is free at the time of use, for general practitioner, the NHS began on the Appointed Day of 5 July 1948. This put into practice Westminster legislation for England and Wales from 1946 and Scotland from 1947, when Clement Attlees Labour Party won the 1945 election he appointed Aneurin Bevan as Health Minister. Bevan then embarked upon what the historian of the NHS, Charles Webster. Three years after the founding of the NHS, Bevan resigned from the Labour government in opposition to the introduction of charges for the provision of dentures and glasses, the following year, Winston Churchills Conservative government introduced prescription charges. These charges were the first of many controversies over reforms to the NHS throughout its history, each of the UKs four nations have their own separate NHS, each with its own history. From its earliest days, the history of the NHS has shown its place in British society reflected and debated in film, TV, cartoons. However, some functions might be performed by one health service on behalf of another. There have been issues about cross-border payments, taken together, the four National Health Services in 2015-16 employed around 1.6 million people with a combined budget of £136.7 billion. In 2014 the total health sector workforce across the UK was 2,165,043 and this broke down into 1,789,586 in England,198,368 in Scotland,110,292 in Wales and 66,797 in Northern Ireland. The NHS is free at the time of use, for general practitioner and emergency treatment not including admission to hospital, people with the right to medical care in European Economic Area nations are also entitled to free treatment by using the European Health Insurance Card. Those from other countries with which the UK has reciprocal arrangements also qualify for free treatment, people not ordinarily resident in the UK are in general not entitled to free hospital treatment, with some exceptions such as refugees. People not ordinarily resident may be subject to an interview to establish their eligibility, patients who do not qualify for free treatment are asked to pay in advance, or to sign a written undertaking to pay, except for emergency treatment. The provision of treatment to non-UK-residents, formerly interpreted liberally, has been increasingly restricted. As of 2016 the surcharge was £200 per year, with exemptions and reductions in some cases, the systems are 98. 8% funded from general taxation and National Insurance contributions, plus small amounts from patient charges for some services
14.
National Health Service (England)
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The National Health Service is the publicly funded national healthcare system for England and one of the four National Health Services of the United Kingdom. It is the largest and the oldest single-payer healthcare system in the world, Some services, such as emergency treatment and treatment of infectious diseases are free for everyone, including visitors. Free healthcare at the point of use comes from the principles at the founding of the National Health Service by the Labour government in 1948. Some specific NHS services do however require a financial contribution from the patient, for eye tests, dental care, prescriptions. However, these charges are often free to vulnerable or low income groups, the NHS provides the majority of healthcare in England, including primary care, in-patient care, long-term healthcare, ophthalmology, and dentistry. The National Health Service Act 1946 came into effect on 5 July 1948, private health care has continued parallel to the NHS, paid for largely by private insurance, it is used by about 8% of the population, generally as an add-on to NHS services. The NHS is largely funded from taxation with a small amount being contributed by National Insurance payments. The UK government department responsible for the NHS is the Department of Health, the Department of Health had a £110 billion budget in 2013-14, most of this being spent on the NHS. Sources do not always clear if they refer to the whole of the NHS or only to England. There is no unified British NHS, the National Health Service in Scotland and Northern Ireland were always separate, the Health and Social Care Act 2012 came into effect in April 2013, giving GP-led groups responsibility for commissioning most local NHS services. Starting in April 2013 Primary Care Trusts are being replaced by General Practitioner -led organisations called Clinical Commissioning Groups, under the new system, a new NHS Commissioning Board, called NHS England, oversees the NHS from the Department of Health. The Act has also associated with the perception of increased private provision of NHS services. NHS Trusts are responding to the Nicholson challenge which involved making £20 billion in savings across the service by 2015, Some NHS organisations are using referral management centres to help reduce inappropriate referrals in an attempt to save the NHS money. Millions of pounds have been spent for these services, 32% of which are provided by private companies, of the 211 clinical commissioning groups surveyed by the British Medical Journal in 2016,184 responded and 72 of those said they had used such schemes. Of those CCGs using these services, 14% could show savings, 12% showed no overall savings, because these services can prevent GPs from referring patients to hospitals, there are some concerns they may delay diagnosis and compromise patient safety. Dr A. J. Cronins controversial novel The Citadel, published in 1937, had fomented extensive debate about the severe inadequacies of health care. The authors innovative ideas were not only essential to the conception of the NHS, a national health service was one of the fundamental assumptions in the Beveridge Report. The Emergency Hospital Service established in 1939 gave a taste of what a National Health Service might look like, Healthcare prior to the war had been an unsatisfactory mix of private, municipal and charity schemes
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NHS Scotland
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NHS Scotland, sometimes styled NHSScotland is the publicly funded healthcare system in Scotland. Health and social policy and funding are the responsibility of the Health. Scotlands NHS was established in 1948, the current Cabinet Secretary for Health and Sport is Shona Robison and the head of staff is the Director-General Health and Social Care and Chief Executive of NHS Scotland, Paul Gray. NHS Scotland had an budget of £12.2 billion in 2015–16. Health and social care are devolved issues in the United Kingdom, the NHS in Scotland was created as an administratively separate organisation in 1948 under the ministerial oversight of the Scottish Office, before being politically devolved in 1999. This separation of powers and financing is not always apparent to the public due to the co-ordination and co-operation where cross-border emergency care is involved. Descriptions of staff numbers can be expressed as headcount and by Whole-Time Equivalent which is an estimate that helps to account of full. Dentists around 4,000 pharmacists, mostly working in community pharmacy positions, opticians allied health professionals administrators, clerical and domestic staff. The NHS in Scotland was formed on 5 July 1948, the service was founded by the National Health Service Act 1947. Prior to the creation of Scotlands NHS in 1948, the state was involved with the provision of healthcare, though it was not universal. Half of Scotland’s landmass was covered by the Highlands and Islands Medical Service, a state-funded health system run directly from Edinburgh. In addition, there had been a substantial state-funded hospital building programme during the war years, current provision of healthcare is the responsibility of 14 geographically based local NHS Boards and 7 National Special Health Boards. Proposals for the establishment of 15 NHS Boards were announced by the Scottish Executive Health Department in December 2000, further details about the role and function of the unified NHS health boards were provided in May 2001. In April 2004, Scotlands health care became an integrated service under the management of NHS Boards. Local authority nominees were added to Board membership to improve co-ordination of health, the remaining 16 Trusts were dissolved from 1 April 2004. Hospitals are now managed by the division of the NHS Board. By April 2014, there were new joint working arrangements in place between the NHS boards and Local Authorities came into effect that included responsibility for social care. There new organisations, which took over from CHPs are called Health, in January 2008, the Scottish Government announced plans for legislation to bring in direct elections as a way to select people for non-executive positions on Health Boards
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NHS Wales
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NHS Wales is the official corporate name of the Welsh National Health Service, a publicly funded healthcare system which is the responsibility of the devolved Welsh Government. Responsibility for NHS Wales was passed to the Welsh Government under devolution in 1999 and has then been the responsibility of the Welsh Minister for Health. NHS Wales provides emergency services and a range of primary, secondary, district General Hospitals provide outpatient, inpatient, and accident and emergency services, and there is a network of community hospitals run by GPs. Specialist hospitals provide services such as units and plastic and cardiac surgery. NHS Wales also funds GP services, dental services, pharmacies, Community services are also provided which includes district nurses, health visitors, midwives, and community-based speech therapists, physiotherapists, and occupational therapists. There are seven Local Health Boards in Wales and three national NHS Trusts, each LHB is responsible for delivering all NHS healthcare services within a geographical area. Three NHS Trusts, called trusts, operate nationwide agencies and services. These are, the Welsh Ambulance Service, Velindre NHS Trust, the current Health Boards were created on 1 October 2009 following a reorganisation of NHS Wales that saw the abolition of 22 Local Health Boards and seven NHS Trusts that had existed since 2003. Since the reorganisation Health Boards are responsible for delivering all NHS services, rather than the two-tiered Trust, Wales largest teaching hospital, the University Hospital of Wales based in Cardiff is the largest hospital outside London and third largest in the United Kingdom. Five of the health boards paid for spot contracts with private healthcare providers costing a total of more than £6 million between 2013 and 2015 to carry out NHS work on elective surgery, another important organisation in the structure is Health Commission Wales. This is an agency of the Welsh Government whose primary role is to centrally organise and fund all tertiary care. It also provides advice and guidance about specialist services to parts of NHS Wales. The NHS Wales Shared Services Partnership is an independent organisation, owned and directed by NHS Wales, NWSSP supports NHS Wales through the provision of a range of support functions and services. NHS Direct Wales/Galw Iechyd Cymru provides a non-emergency telephone health advice and it operates 24 hours a day every day of the year with callers being given the option of communicating in Welsh or English. NHS Direct Wales is part of the Welsh Ambulance Service NHS Trust, there are eight Community Health Councils in Wales which monitor the quality of the NHS services provided within a Health Board area and provide information about available services to the public. NHS Wales provides public healthcare in Wales and directly employs some 72,000 staff and it employs a wide range of staff such as doctors, nurses, midwives and paramedics as well as allied health professionals such as technicians, microbiologists, radiographers and pharmacists. Staff in its services include administrative staff, estates and management staff, catering. Most staff working for NHS Wales, including staff and GPs, are eligible to join the NHS Pension Scheme which
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Health and Social Care in Northern Ireland
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Health and Social Care in Northern Ireland is the designation of the publicly funded service which provides public health and other social care services in Northern Ireland. It is free of charge to all citizens of Northern Ireland, for services such as A&E, patients simply walk in, state their name and date of birth, are given treatment and then leave. Patients are unaware of costs incurred by them using the service and it is sometimes called the NHS, as in England, Scotland and Wales, but differs from the NHS in England and Wales in that it provides not only health care but social care too. In England and Wales, the NHS services only provide health care, Social services are provided by local councils. The Health and Social Care service was created by the Parliament of Northern Ireland in 1948 after the Beveridge Report, the Health and Social Care Act 2009 led to a reorganisation of health and social care delivery in Northern Ireland, reducing the number of organisations involved. This Act established the Health and Social Care Board and five Health and Social Care Trusts which are responsible for the delivery of primary, secondary, the act also established five local commissioning groups which work in parallel with the health and social care trusts. The Department of Health is now organised under a Permanent Secretary into several groups and these are the Planning and Resources Group, Strategic Planning and Modernisation Group and Primary, Secondary and Community Care Group and the 5 Professional Groups. The Department’s executive agency responsible for the oversight, coordination and overall provision of health, the 19 Health and Social Services Trusts were merged into six Health and Social Care Trusts which became operational on 1 April 2007. There are about 350 GP Practices in the region, in 2016 Michelle O’Neill produced a plan to install a named district nurse, health visitor and social worker in every practice. 54 pharmacists are to start in practices in December 2016 with one in practice by 2021. The number of GP training places is to increase to 111, on 29 September 2008 Health minister Michael McGimpsey announced that Prescription charges were to be phased out by April 2010, being first reduced to £3.00 in January 2009. This was widely accepted by the four parties of the Northern Ireland Executive plus the Alliance Party of Northern Ireland. The move brought Northern Ireland in line with the Scottish and Welsh systems which had already abolished charges and he says that there are various reasons for this. It is difficult to get out of acute care without closing buildings. Information technology systems may not be compatible and patient confidentiality hinders the sharing of information, Health services are free but social care is means tested. But, he says, the greatest difficulties lie in the different cultures and values of health, until 2014 the Kingsbridge private hospital in Belfast was used to reduce waiting lists for routine surgery. The NHS waiting list target in Northern Ireland is 52 weeks, not 18 as in England, 10% of healthcare provided in the region is paid for privately
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Ipsos MORI
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Ipsos MORI is the second largest market research organisation in the United Kingdom, formed by a merger of Ipsos UK and MORI, two of Britains leading survey companies, in October 2005. Ipsos MORI conduct surveys for a range of major organisations as well as other market research agencies. Ipsos MORIs Social Research Institute works extensively for the Government of the United Kingdom, looking at public attitudes to key public services, issues such as identity, social cohesion, physical capital and the impact of place on attitudes are all key themes of the Institutes work. The company also specialises in mass media, brand loyalty, marketing and advertising research, the organisation maintains a freely available archive of opinion polls and public attitude research from 1970 onwards on its UK website. Ipsos MORI has research offices in London, Manchester, Edinburgh and their call center is in Edinburgh. Ipsos is one of the largest survey research organisations in the world, with offices in more than 80 countries, founded in the mid 1970s in France by Didier Truchot and Jean Marc Lech. In 1946, Mark Abrams formed a market Research company called RSL, MORI was founded in 1969 by Robert Worcester, and throughout its existence was the largest independent research organisation in the United Kingdom. MORI was bought by Ipsos in 2005 for £88 million, the company being now known as Ipsos MORI. The same year, Robert Worcester stepped down from chairmanship of MORI, ben Page is now Chief Executive. In 2006, Ipsos MORI were the first research agency in the world to gain ISO20252, Ipsos MORI is a current member of the Market Research Society and are obliged to conduct surveys according to their rules. For example, Ipsos holds the data they collect in the strictest confidence, in May 2013 The Sunday Times reported that Ipsos MORI had negotiated an agreement with the EE mobile phone network to commercialise the data on that company’s 23 million subscribers. The article stated that Ipsos MORI was looking to sell this data to the Metropolitan Police, the data included gender, age, postcode, websites visited, time of day text is sent location of customer when call is made. When confronted by the newspaper, the Metropolitan Police indicated that they would not be taking the discussions any further, Ipsos MORIs research is conducted via a wide range of methodologies, especially computer-assisted telephone interviewing, as well as face-to-face and internet surveys. Telephone surveys use a method called random digit dialing and this system basically uses randomly generated, but area-specific, telephone numbers. This is the method for telephone samples as ex-directory households are included thus not biasing the sample in any way. Ipsos MORI are able to lawfully to use technology as they use it for research purposes as opposed to sales
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Prescription drugs
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A prescription drug 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 meaning take. Prescription drugs are often dispensed together with a monograph that gives detailed information about the drug, the use of prescription drugs has been increasing since the 1960s. In the U. S. 88% of older adults use at least 1 prescription drug, who is able to prescribe the drug. When purchasing a drug under the PBS the maximum price a consumer pays is the patient co-payment contribution and those covered by government entitlements and those covered under the Repatriation Pharmaceutical Benefits Scheme have a reduced co-payment, which is $6.00 in 2014. The table below indicates the changes in co-payments over the years and these co-payments are compulsory and cannot be discounted by pharmacies under any circumstances. Private prescriptions are issued for medicines not covered on the PBS, or being used off-label, the patient pays the pharmacy for medicines privately prescribed. In the United Kingdom the Medicines Act 1968 and Prescription Only Medicines Order 1997 contain regulations that cover the supply of sale, use, prescribing is also covered by this legislation. A patient visits a medical practitioner or dentist authorised to prescribe drugs and certain other medical items, also, suitably qualified and experienced nurses and pharmacists may be independent prescribers. Both can prescribe all POMs but pharmacists are not allowed to prescribe schedule 1 controlled drugs, once issued, a prescription is taken by the patient to a pharmacy, which dispenses the medicine. Most prescriptions in the UK are NHS prescriptions, subject to a standard charge unrelated to what is dispensed, the NHS prescription fee was increased to £8. The pharmacy charges the NHS the actual cost of the medicine, a patient can consolidate prescription charges using a prescription payment certificate, effectively capping costs at £29.10 per quarter or £104.00 per year. Outside the NHS, private prescriptions are issued by private medical practitioners, NHS supply beyond three months worth is not covered, and must be purchased privately. A patient pays the pharmacy the normal price for medicine prescribed outside the NHS, in the United States, the Federal Food, Drug, and Cosmetic Act defines what substances require a prescription in order to be dispensed by a pharmacy. The Controlled Substances Act was enacted into law by the Congress of the United States in 1970, the CSA is the federal U. S. drug law under which the manufacture, importation, possession, use and distribution of certain substances is regulated. The legislation created five schedules with varying qualifications for a substance to be included in each, the safety and effectiveness of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The Food and Drug Administration is charged with implementing this law, misuse or abuse of prescription drugs can lead to adverse drug events, including those due to dangerous drug interactions
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Federal Food, Drug, and Cosmetic Act
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A principal author of this law was Royal S. Copeland, a three-term U. S. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C, the act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and it replaced the earlier Pure Food and Drug Act of 1906. The FDC Act has ten chapters, I, prohibited Acts and Penalties This section contains both civil law and criminal law clauses. Most violations under the act are civil, though repeated, intentional, notably, the FD&C Act uses strict liability due to the Dotterweich and Park Supreme Court cases. It is one of a small number of criminal statutes that does. Food There is a distinction in food adulteration between those that are added and those that are naturally present, general Authority 704 allows inspections of regulated entities. Inspection results are reported on Form 483, tobacco Products X. Miscellaneous The FD&C is perhaps best known by the consumer because of its use in the naming of food coloring additives, such as FD&C Yellow No.6. The Act made the certification of food color additives mandatory. Some food colorings are generally recognized as safe by the FDA, the FDA lists nine FD&C certified color additives for use in foods in the United States, and numerous D&C colorings allowed only in drugs for external application or cosmetics. Color additives derived from sources, such as vegetables, minerals or animals. Both artificial and naturally derived color additives are subject to standards of safety before their approval for use in foods. There are also D&C colors that are approved for use in pharmaceuticals for external application. The FFDCA requires producers of food additives to demonstrate to a certainty that no harm will result from the intended use of an additive. If the FDA finds an additive to be safe the agency issues a regulation specifying the conditions under which the additive may be safely used, the full definition, can be found in Section 201 of the FD&C Act, which provides for any additional exclusions. If no such evidence exists, they must state this fact clearly on their labeling, bottled water is regulated by the FDA as a food. The Agency has published identity standards for types of water, and regulations covering water processing and bottling, water quality, the FDA can and does inspect cosmetics manufacturing facilities to ensure that cosmetics are not adulterated. On May 28,1976, the FD&C Act was amended to include regulation for medical devices, the amendment required that all medical devices be classified into one of three classes, Class I, Devices that do not require premarket approval or clearance but must follow general controls
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Controlled Substances Act
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The Controlled Substances Act is the statute establishing federal U. S. drug policy under which the manufacture, importation, possession, use and distribution of certain substances is regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, the Act also served as the national implementing legislation for the Single Convention on Narcotic Drugs. The legislation created five Schedules, with varying qualifications for a substance to be included in each, classification decisions are required to be made on criteria including potential for abuse, currently accepted medical use in treatment in the United States, and international treaties. The nation first outlawed addictive drugs in the early 1900s and the International Opium Convention helped lead international agreements regulating trade, the Food and Drugs Act of 1906 was the beginning of over 200 laws concerning public health and consumer protections. Others were the Federal Food, Drug, and Cosmetic Act, in 1969, President Richard Nixon announced that the Attorney General, John N. Shafer—to study cannabis abuse in the United States. It implies an overwhelming indictment of the behavior which we believe is not appropriate, the actual and potential harm of use of the drug is not great enough to justify intrusion by the criminal law into private behavior, a step which our society takes only with the greatest reluctance. According to David T. Courtwright, the Act was part of a reform package designed to rationalize. It eliminated mandatory minimum sentences and provided support for drug treatment, king notes that the rehabilitation clauses were added as a compromise to Senator Jim Hughes, who favored a moderate approach. The bill, as introduced by Senator Everett Dirksen, ran to 91 pages, since its enactment in 1970, the Act has been amended several times, The Medical Device Amendments of 1976. The Psychotropic Substances Act of 1978 added provisions implementing the Convention on Psychotropic Substances, the Controlled Substances Penalties Amendments Act of 1984. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 The Electronic Prescriptions for Controlled Substances 2010, the Controlled Substances Act consists of 2 subchapters. Subchapter II describes the laws for exportation and importation of controlled substances, again specifying fines, the Drug Enforcement Administration was established in 1973, combining the Bureau of Narcotics and Dangerous Drugs and Customs drug agents. When a petition is received by the DEA, the agency begins its own investigation of the drug and this request is sent to the Assistant Secretary of Health of HHS. Under certain circumstances, the Government may temporarily schedule a drug without following the normal procedure, an example is when international treaties require control of a substance. In addition,21 U. S. C. §811 allows the Attorney General to temporarily place a substance in Schedule I to avoid an imminent hazard to the public safety, in any case, once these proceedings are complete, the temporary order is automatically vacated. Unlike ordinary scheduling proceedings, such orders are not subject to judicial review. The CSA also creates a system of distribution for those authorized to handle controlled substances. The cornerstone of this system is the registration of all those authorized by the DEA to handle controlled substances
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Prescription Drug Marketing Act
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The Prescription Drug Marketing Act of 1987 is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and its designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market for prescription drugs, the PDMA was modified by the Prescription Drug Amendments of 1992 on August 26,1992. The U. S. Food and Drug Administration issued regulations implementing the PDMA in 1990 and 1999, Food and Drug Administration Good Distribution Practice Inverse benefit law Regulation of therapeutic goods PDMA article FDA page on PDMA law, regulations and guidance
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Hatch-Waxman exemption
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In patent law, the research exemption or safe harbor exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. This exemption allows generic manufacturers to prepare generic drugs in advance of the patent expiration, in the United States, this exemption is also technically called §271 exemption or Hatch-Waxman exemption. In 2005, the U. S. Supreme Court considered the scope of the Hatch-Waxman exemption in Merck v. Integra, in Canada, this exemption is known as the Bolar provision or Roche-Bolar provision, named after the case Roche Products v. Bolar Pharmaceutical. In the European Union, equivalent exemptions are allowed under the terms of EC Directives 2001/82/EC and 2001/83/EC, the common law research exemption is an affirmative defense to infringement where the alleged infringer is using a patented invention for research purposes. The doctrine originated in the 1813 decision by Justice Joseph Story appellate decision Whittemore v. Cutter,29 Fed, subsequent decisions later distinguished between commercial and non-commercial research. In 2002, the Court of Appeals for the Federal Circuit dramatically limited the scope of the exemption in Madey v. Duke University,307 F. 3d 1351,1362. The court did not reject the defense, but left only a narrow and strictly limited experimental use defense for amusement, to satisfy idle curiosity. The court also precludes the defense where, regardless of profit motive, in the case of a research university like Duke University, the court held that the alleged use was in furtherance of its legitimate business, and thus the defense was inapplicable. In Merck KGaA v. Integra Lifesciences I, Ltd.545 U. S.193, the United States Supreme Court held that the use of patented compounds in preclinical studies is protected under 35 U. S
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Marihuana Tax Act of 1937
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The Marihuana Tax Act of 1937, Pub. 238, 75th Congress,50 Stat.551 was a United States Act that placed a tax on the sale of cannabis. The H. R.6385 act was drafted by Harry Anslinger and introduced by Rep. Robert L. Doughton of North Carolina, the seventy-fifth Congress held hearings on April 27,28, 29th, 30th, and May 4,1937. Upon the congressional confirmation, the H. R.6385 act was redrafted as H. R.6906. The Act is now referred to, using the modern spelling. This act was overturned in 1969 in Leary v. United States, regulations and restrictions on the sale of cannabis sativa as a drug began as early as 1906. The head of the Federal Bureau of Narcotics, Harry J. Anslinger, argued that, in the 1930s, the FBN had noticed an increase of reports of people smoking marijuana. He had also, in 1935, received support from president Franklin D. Roosevelt for adoption of the Uniform State Narcotic Act, the total production of hemp fiber in the United States had in 1933 decreased to around 500 tons/year. Cultivation of hemp began to increase in 1934 and 1935 but production remained at low volume compared with other fibers. Some parties have argued that the aim of the Act was to reduce the size of the hemp industry largely as an effort of businessmen Andrew Mellon, Randolph Hearst, and the Du Pont family. The same parties have argued that with the invention of the decorticator and these parties argue that Hearst felt that this was a threat to his extensive timber holdings. Mellon, Secretary of the Treasury and the wealthiest man in the US, had invested heavily in the Du Pont familys new synthetic fiber, nylon, a fiber that was competing with hemp. In 1916, United States Department of Agriculture chief scientists Jason L. Merrill and Lyster H. Dewey created a paper, Dewey and Merrill believed that hemp hurds were a suitable source for paper production. However, later research does not confirm this, the concentration of cellulose in hemp hurds is only between 32% and 38%. In 2003, 95% of the hemp hurds in the EU were used for animal bedding, the DuPont Company and many industrial historians dispute a link between nylon and hemp. They argue that the purpose of developing the nylon was to produce a fiber that could compete with silk, the American Medical Association opposed the act because the tax was imposed on physicians prescribing cannabis, retail pharmacists selling cannabis, and medical cannabis cultivation/manufacturing. The AMA proposed that cannabis instead be added to the Harrison Narcotics Tax Act, the bill was passed over the last-minute objections of the American Medical Association. Dr. Marijuana is not the correct term, yet the burden of this bill is placed heavily on the doctors and pharmacists of this country
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Food and Drug Administration
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The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. As of 2017, 3/4th of the FDA budget is funded by the pharmaceutical companies due to the Prescription drug user fee act and these include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice, the Commissioner reports to the Secretary of Health and Human Services. Dr. Robert M. Califf, MD is the current commissioner, who took over in February 2016 for Dr. Stephen Ostroff, the FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, in 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. The site was renamed from the White Oak Naval Surface Warfare Center to the Federal Research Center at White Oak, the first building, the Life Sciences Laboratory, was dedicated and opened with 104 employees on the campus in December 2003. Only one original building from the facility was kept. All other buildings are new construction, the project is slated to be completed by 2017, assuming future Congressional funding While most of the Centers are located in the Washington, D. C. The Office of Regulatory Affairs is considered the eyes and ears of the agency, the Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. Districts are based roughly on the divisions of the federal court system. Each district comprises a main office and a number of Resident Posts. ORA also includes the Agencys network of laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, the Office of Criminal Investigations was established in 1991 to investigate criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and dont focus on aspects of the regulated industries. In many cases, OCI pursues cases involving Title 18 violations, OCI Special Agents often come from other criminal investigations backgrounds, and work closely with the Federal Bureau of Investigation, Assistant Attorney General, and even Interpol. OCI receives cases from a variety of sources—including ORA, local agencies, OCI is a smaller branch, comprising about 200 agents nationwide. The FDA frequently works with federal agencies, including the Department of Agriculture, Drug Enforcement Administration, Customs and Border Protection. Often local and state government agencies also work with the FDA to provide regulatory inspections, the FDA regulates more than US$1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States
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United States Department of Justice
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The department was formed in 1870 during the Ulysses S. Grant administration. In its early years, the DOJ vigorously prosecuted Ku Klux Klan members, the Department of Justice administers several federal law enforcement agencies including the Federal Bureau of Investigation and the Drug Enforcement Administration. The department has responsibility to investigate instances of fraud, to represent the United States in legal matters such as in the Supreme Court. The department also has responsibilities to review actions of law enforcement conduct by the Violent Crime Control. The Department is headed by the United States Attorney General, who is nominated by the President, the current Attorney General is Jeff Sessions. The U. S. Attorney General was initially a one-person and it was established by the Judiciary Act of 1789, but this grew with the bureaucracy. At one time the Attorney General gave legal advice to the U. S. Congress as well as the President, until March 3,1853, the salary of the Attorney General was set by statute at less than the amount paid to other Cabinet members. Early Attorneys General supplemented their salary by engaging in private practice of law. Following unsuccessful efforts to put the Attorney Generals Office on a footing, in 1869. On February 19,1868, Lawrence introduced a bill in Congress to create the Department of Justice, President Ulysses S. Grant then signed the bill into law on June 22,1870. The Department of Justice officially began operations on July 1,1870, just prior to the Civil War, in February 1861, the Confederate States of America established a Department of Justice. Grant appointed Amos T. Akerman as Attorney General and Benjamin H. Bristow as Americas first Solicitor General, both Akerman and Bristow used the Department of Justice to vigorously prosecute Ku Klux Klan members in the early 1870s. In the first few years of Grants first term in there were 1000 indictments against Klan members with over 550 convictions from the Department of Justice. The result was a decrease in violence in the South. Akerman gave credit to Grant and told a friend that no one was better or stronger then Grant when it came to prosecuting terrorists. Akermans successor, George H. Williams, in December 1871, the law did create a new office, that of Solicitor General, to supervise and conduct government litigation in the Supreme Court of the United States. In 1884, control of federal prisons was transferred to the new department, new facilities were built, including the penitentiary at Leavenworth in 1895, and a facility for women located in West Virginia, at Alderson was established in 1924. The U. S. Department of Justice building was completed in 1935 from a design by Milton Bennett Medary, upon Medarys death in 1929, the other partners of his Philadelphia firm Zantzinger, Borie and Medary took over the project
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Drug Enforcement Administration
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The Drug Enforcement Administration is a United States federal law enforcement agency under the U. S. Department of Justice, tasked with combating drug smuggling and use within the United States. S. It has sole responsibility for coordinating and pursuing U. S. drug investigations both domestic, and abroad, the Drug Enforcement Administration was established on July 1,1973, by Reorganization Plan No.2 of 1973, signed by President Richard Nixon on July 28. It proposed the creation of a federal agency to enforce the federal drug laws as well as consolidate and coordinate the governments drug control activities. Congress accepted the proposal, as they were concerned with the availability of drugs. From the early 1970s, DEA headquarters was located at 1405 I Street NW in downtown Washington, however, then–Attorney General Edwin Meese determined that the headquarters had to be located in close proximity to the Attorney Generals office. Thus, in 1989, the relocated to 600–700 Army-Navy Drive in the Pentagon City area of Arlington, Virginia. On April 19,1995, Timothy McVeigh attacked the Alfred P, security measures include hydraulic steel roadplates to enforce standoff distance from the building, metal detectors, and guard stations. In February 2003, the DEA established a Digital Evidence Laboratory within its Office of Forensic Sciences, the DEA is headed by an Administrator of Drug Enforcement appointed by the President of the United States and confirmed by the U. S. Senate. The Administrator reports to the Attorney General through the Deputy Attorney General, the Administrator is assisted by a Deputy Administrator, the Chief of Operations, the Chief Inspector, and three Assistant Administrators. Other senior staff include the financial officer and the Chief Counsel. The Administrator and Deputy Administrator are the only presidentially-appointed personnel in the DEA, DEAs headquarters is located in Arlington, Virginia across from the Pentagon. It maintains its own DEA Academy located on the United States Marine Corps base at Quantico and it maintains 21 domestic field divisions with 227 field offices and 86 foreign offices in 62 countries. With a budget exceeding 2 billion dollars, DEA employs over 10,800 people, becoming a Special Agent or Intelligence Analyst with the DEA is a competitive process. DEA agents starting salary is $49, 746–$55,483, after four years working as an agent, the salary jumps to above $92,592. Upon graduation, recruits earn themselves the title of DEA Special Agent, the DEA excludes from consideration job-applicants who have a history of any use of narcotics or illicit drugs. Investigation usually includes a polygraph test for special-agent, diversion-investigator, exceptions to this policy may be made for applicants who admit to limited youthful and experimental use of marijuana. The DEAs relatively firm stance on this issue contrasts with that of the Federal Bureau of Investigation, the DEA Aviation Division or Office of Aviation Operations is an airborne division based in Fort Worth Alliance Airport, Texas. The current OA fleet consists of 106 aircraft and 124 DEA pilots, rapid Response Teams was decommissioned by DEA Administrator Chuck Rosenburg on March 2017 via memorandum
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Drug discovery
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In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery, hits from these screens are then tested in cells and then in animals for efficacy. Once a compound that fulfills all of these requirements has been identified, one or more of these steps may, but not necessarily, involve computer-aided drug design. Modern drug discovery is usually a capital-intensive process that involves large investments by pharmaceutical industry corporations as well as national governments. Despite advances in technology and understanding of systems, drug discovery is still a lengthy, expensive, difficult. In 2010, the research and development cost of new molecular entity was about US$1.8 billion. Drug discovery is done by companies, with research assistance from universities. The final product of drug discovery is a patent on the potential drug, the drug requires very expensive Phase I, II and III clinical trials, and most of them fail. Small companies have a role, often then selling the rights to larger companies that have the resources to run the clinical trials. This made for the beginning of the era in pharmacology, as pure chemicals, instead of crude extracts. Examples of drug compounds isolated from crude preparations are morphine, the agent in opium, and digoxin. Organic chemistry also led to the synthesis of many of the natural products isolated from biological sources, historically substances, whether crude extracts or purified chemicals were screened for biological activity without knowledge of the biological target. Only after a substance was identified was an effort made to identify the target. This approach is known as classical pharmacology, forward pharmacology, or phenotypic drug discovery, later, small molecules were synthesized to specifically target a known physiological/pathological pathway, rather than adopt the mass screening of banks of stored compounds. Cloning of human proteins made possible the screening of large libraries of compounds against specific targets thought to be linked to specific diseases and this approach is known as reverse pharmacology and is the most frequently used approach today. The definition of target itself is something argued within the pharmaceutical industry, generally, the target is the naturally existing cellular or molecular structure involved in the pathology of interest that the drug-in-development is meant to act on. However, the distinction between a new and established target can be made without an understanding of just what a target is. This distinction is made by pharmaceutical companies engaged in discovery
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Drug design
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Drug design, often referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target. The drug is most commonly a small molecule that activates or inhibits the function of a biomolecule such as a protein. In the most basic sense, drug design involves the design of molecules that are complementary in shape and charge to the target with which they interact. Drug design frequently but not necessarily relies on computer modeling techniques and this type of modeling is sometimes referred to as computer-aided drug design. Finally, drug design relies on the knowledge of the three-dimensional structure of the biomolecular target is known as structure-based drug design. The phrase drug design is to some extent a misnomer, a more accurate term is ligand design. These other characteristics are difficult to predict with rational design techniques. Furthermore, in vitro experiments complemented with computation methods are used in early drug discovery to select compounds with more favorable ADME. Potential drug targets are not necessarily disease causing but must by definition be disease modifying, in some cases, small molecules will be designed to enhance or inhibit the target function in the specific disease modifying pathway. Small molecules will be designed that are complementary to the site of target. Small molecules can be designed so as not to any other important off-target molecules since drug interactions with off-target molecules may lead to undesirable side effects. Due to similarities in binding sites, closely related targets identified through sequence homology have the highest chance of cross reactivity, most commonly, drugs are organic small molecules produced through chemical synthesis, but biopolymer-based drugs produced through biological processes are becoming increasingly more common. In addition, mRNA-based gene silencing technologies may have therapeutic applications, in order for a biomolecule to be selected as a drug target, two essential pieces of information are required. The first is evidence that modulation of the target will be disease modifying and this knowledge may come from, for example, disease linkage studies that show an association between mutations in the biological target and certain disease states. The second is that the target is druggable and this means that it is capable of binding to a small molecule and that its activity can be modulated by the small molecule. Once a suitable target has been identified, the target is normally cloned and produced and purified, the purified protein is then used to establish a screening assay. In addition, the structure of the target may be determined. The search for molecules that bind to the target is begun by screening libraries of potential drug compounds
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Drug development
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Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. Broadly, the process of development can be divided into pre-clinical and clinical work. New chemical entities are compounds that emerge from the process of drug discovery and these have promising activity against a particular biological target that is important in disease. However, little is known about the safety, toxicity, pharmacokinetics and it is the function of drug development to assess all of these parameters prior to human clinical trials. A further major objective of development is to recommend the dose. In addition, drug development must establish the physicochemical properties of the NCE, its chemical makeup, stability, manufacturers must optimize the process they use to make the chemical so they can scale up from a medicinal chemist producing milligrams, to manufacturing on the kilogram and ton scale. They further examine the product for suitability to package as capsules, tablets, aerosol, intramuscular injectable, subcutaneous injectable, together, these processes are known in preclinical development as chemistry, manufacturing, and control. Many aspects of development focus on satisfying the regulatory requirements of drug licensing authorities. These generally constitute a number of tests designed to determine the major toxicities of a novel compound prior to first use in humans. It is a requirement that an assessment of major organ toxicity be performed. The information is gathered from this testing, as well as information on CMC. If the IND is approved, development moves to the clinical phase, Clinical trials involve three or four steps, Phase I trials, usually in healthy volunteers, determine safety and dosing. Phase II trials are used to get a reading of efficacy. Phase III trials are large, pivotal trials to determine safety, if safety and efficacy are adequately proved, clinical testing may stop at this step and the NCE advances to the new drug application stage. Phase IV trials are post-approval trials that are sometimes a condition attached by the FDA, the process of defining characteristics of the drug does not stop once an NCE begins human clinical trials. They must also test the compound for its potential to cause cancer, in the United States, this process is called a new drug application or NDA. Most NCEs fail during drug development, either because they have unacceptable toxicity or because they simply do not have the effect on the targeted disease as shown in clinical trials. The full cost of bringing a new drug to market – from discovery through clinical trials to approval – is complex, typically, companies spend tens to hundreds of millions of U. S. dollars
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New drug application
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Is the drug’s proposed labeling appropriate, and what should it contain. Are the methods used in manufacturing the drug and the used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality. Exceptions to this process include voter driven initiatives for medical marijuana in certain states, to legally test the drug on human subjects in the U. S. the maker must first obtain an Investigational New Drug designation from FDA. The legal requirement for approval is substantial evidence of effectiveness demonstrated through controlled clinical trials and this standard lies at the heart of the regulatory program for drugs. It means that the experience of doctors, the opinion of experts, or testimonials from patients. Data for the submission must come from rigorous clinical trials, the trials are typically conducted in three phases, Phase 1, The drug is tested in a few healthy volunteers to determine if it is acutely toxic. Phase 2, The drug is tested for efficacy and safety in a larger sample pool. The majority of drugs fail in Phase 2 clinical trials due to the not being as effective as anticipated. Phase 3, The drug is tested in double-blind, placebo controlled trials to demonstrate that it works. Sponsors typically confer with FDA prior to starting these trials to determine what data is needed and these are post-approval trials that are sometimes a condition attached by the FDA to the approval. Many approved medications for serious illnesses have severe and even life-threatening side effects, even relatively safe and well understood OTC drugs such as aspirin can be dangerous if used incorrectly. The results of the program are codified in an FDA-approved public document that is called the product label. The prescribing information is available on the web, from the FDA, drug manufacturers. The main purpose of a label is to provide healthcare providers with adequate information. Currently, the FDA decision process lacks transparency, however, efforts are underway to standardize the benefit-risk assessment of new medicines, once approval of an NDA is obtained, the new drug can be legally marketed starting that day in the U. S. Once the application is submitted, the FDA has 60 days to conduct a preliminary review, a standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months. Of original NDAs submitted in 2009,94 out of 131 were in eCTD format, biologics, such as vaccines and many recombinant proteins used in medical treatments are generally approved by FDA via a Biologic License Application, rather than an NDA. The manufacture of biologics is considered to differ fundamentally from that of less complex chemicals, most biological drugs, including a majority of recombinant proteins are considered ineligible for an ANDA under current US law
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Investigational New Drug
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The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is cleared, the drug usually enters a Phase 1 clinical trial. Regulations are primarily at 21 C. F. R, also included are any previous experience with the drug in humans. The chemical stability and activity of the product must also have been tested and this information is assessed to ensure that the company can adequately produce and supply consistent and active batches of the drug. Clinical Protocols and Investigator Information – Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks. Finally, commitments to obtain informed consent from the subjects, to obtain review of the study by an institutional review board. A physician might submit a research IND to propose studying an unapproved drug, emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND. Experimental drugs under an IND must be labeled, Caution, New Drug – Limited by Federal law to investigational use, the FDA runs a medical marijuana IND program. As of 2011, four patients continue to receive cannabis from the government under the program, investigational New Drug Application Process Center for Drug Evaluation and Research, Food and Drug Administration. ICH Guidance for Industry, E6 Good Clinical Practice, Consolidated Guidance, achieving a Successful US IND Filing The Regulatory Affairs Journal. Achieving a Successful US IND Filing The Regulatory Affairs Journal, OCLC317650570,50016270,163149563 IND Forms and Instructions from the US Food and Drug Administration
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Clinical trial
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Clinical trials are experiments or observations done in clinical research. Clinical trials generate data on safety and efficacy and they are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is safe or effective, only that the trial may be conducted. Clinical trials can vary in size and cost, and they can involve a research center or multiple centers. Clinical study design aims to ensure the validity and reproducibility of the results. Trials can be costly, depending on a number of factors. The sponsor may be an organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, only 10 percent of all drugs started in human clinical trials become an approved drug. Some clinical trials involve healthy subjects with no pre-existing medical conditions, other clinical trials pertain to patients with specific health conditions who are willing to try an experimental treatment. When participants are healthy volunteers who receive financial incentives, the goals are different than when the participants are sick, during dosing periods, study subjects typically remain under supervision for one to 40 nights. Usually pilot experiments are conducted to gain insights for design of the trial to follow. There are two goals to testing medical treatments, to whether they work well enough, called efficacy or effectiveness. The benefits must outweigh the risks, in the US, the elderly constitute only 14 percent of the population, while they consume over one-third of drugs. Women, children and people with unrelated medical conditions are frequently excluded. For women, a reason for exclusion is the possibility of pregnancy. If the sponsor cannot obtain enough test subjects at one location investigators at other locations are recruited to join the study, during the trial, investigators recruit subjects with the predetermined characteristics, administer the treatment and collect data on the subjects health for a defined time period. The researchers send the data to the sponsor, who then analyzes the pooled data using statistical tests. Except for small, single-location trials, the design and objectives are specified in a document called a clinical trial protocol
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Randomized controlled trial
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A randomized controlled trial is a type of scientific experiment which aims to reduce bias when testing a new treatment. The people participating in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving treatment as the control. The RCT is often considered the standard for a clinical trial. RCTs are often used to test the efficacy or effectiveness of various types of intervention and may provide information about adverse effects. Random assignment of intervention is done after subjects have been assessed for eligibility and recruited, random allocation in real trials is complex, but conceptually the process is like tossing a coin. After randomization, the two groups of subjects are followed in exactly the way and the only differences between them is the care they receive. For example, in terms of procedures, tests, outpatient visits, the most important advantage of proper randomization is that it minimizes allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. The term randomized trials omits mention of controls and can describe studies that compare multiple treatment groups with each other, not all randomized clinical trials are randomized controlled trials. The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy, randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce, and in education. Later, randomized experiments appeared in agriculture, due to Jerzy Neyman, fishers experimental research and his writings popularized randomized experiments. The first published RCT in medicine appeared in the 1948 paper entitled Streptomycin treatment of pulmonary tuberculosis, one of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT. By the late 20th century, RCTs were recognized as the method for rational therapeutics in medicine. As of 2004, more than 150,000 RCTs were in the Cochrane Library, randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias. Although the principle of clinical equipoise common to clinical trials has been applied to RCTs, for one, it has been argued that equipoise itself is insufficient to justify RCTs. For another, collective equipoise can conflict with a lack of personal equipoise, further research is necessary to determine the prevalence of and ways to address this therapeutic misconception. The RCT method may also create cultural effects that have not been well understood, for example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful. However, trial registration may still occur late or not at all, Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication. One way to classify RCTs is by study design, crossover – over time, each participant receives an intervention in a random sequence
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Pharmacovigilance
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The etymological roots for the word pharmacovigilance are, pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse reactions, or ADRs. In fact, in order to market or to test a pharmaceutical product in most countries, 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. Companies must conduct a comprehensive safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations. Pharmacovigilance has its own terminology that is important to understand. Most of the terms are used within this article and are peculiar to drug safety. Adverse drug reaction is a side effect occurring with a drug where a positive relationship between the event and the drug is thought, or has been proven, to exist. Adverse event 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, 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 refers to a program to determine the safety and/or efficacy of a drug in patients. The design of a trial will depend on the drug. Control group is a group of patients that is used as a standard of comparison within a clinical trial. The control group may be taking a placebo 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 drugs 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 relationship between an event and a drug exists. Effectiveness is the extent to which a drug works under real world circumstances, efficacy is the extent to which a drug works under ideal circumstances, i. e. in clinical trials. Event refers to an adverse event, 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 states otherwise
. PMID 26998708.
