NUTRACEUTICALS

Chia is grown commercially for its seeds rich in α-linolenic acid.

A Nutraceutical is a pharmaceutical-grade and standardized nutrient.^[1] In the US, "nutraceuticals" do not exist as a regulatory category; they are regulated as dietary supplements and food additives by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.

Regulation[edit]

Nutraceuticals are treated differently in different jurisdictions.

Canada[edit]

Under Canadian law, a nutraceutical can either be marketed as a food or as a drug; the terms "nutraceutical" and "functional food" have no legal distinction,^[3] referring to "a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food [and] is demonstrated to have a physiological benefit or provide protection against chronic disease."

United States[edit]

The term "nutraceutical" is not defined by US law.^[4] Depending on its ingredients and the claims with which it is marketed, a product is regulated as a drug, dietary supplement, food ingredient, or food.^[5][6]

International sources[edit]

In the global market, there are significant product quality issues.^[7] Nutraceuticals from the international market may claim to use organic or exotic ingredients, yet the lack of regulation may compromise the safety and effectiveness of products. Companies looking to create a wide profit margin may create unregulated products overseas with low-quality or ineffective ingredients.

Market[edit]

A market research report produced in 2012 projected that the worldwide nutraceuticals market would reach US$250 billion by 2018,^[8] defining that market as "Dietary Supplements (Vitamins, Minerals, Herbals, Non-Herbals, & Others), and Functional Foods & Beverages"^[9]

Classification of nutraceuticals[edit]

Nutraceuticals are products derived from food sources that are purported to provide extra health benefits, in addition to the basic nutritional value found in foods. Depending on the jurisdiction, products may claim to prevent chronic diseases, improve health, delay the aging process, increase life expectancy, or support the structure or function of the body.^[10]

Dietary supplements[edit]

Dietary supplements, such as the vitamin B supplement shown above, are typically sold in pill form.

In the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the term: “A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.”^[11]

Dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before marketing, but companies must register their manufacturing facilities with the FDA and follow current good manufacturing practices (cGMPs). With a few well-defined exceptions, dietary supplements may only be marketed to support the structure or function of the body, and may not claim to treat a disease or condition, and must include a label that says: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The exceptions are when the FDA has reviewed and approved a health claim. In those situations the FDA also stipulates the exact wording allowed.

Functional foods[edit]

Considered a father of Western medicine, Hippocrates advocated the healing effects of food.

Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as vitamin D to milk.

Health Canada defines functional foods as “ordinary food that has components or ingredients added to give it a specific medical or physiologicalbenefit, other than a purely nutritional effect.”^[12] In Japan, all functional foods must meet three established requirements: foods should be (1) present in their naturally occurring form, rather than a capsule, tablet, or powder; (2) consumed in the diet as often as daily; and (3) should regulate a biological process in hopes of preventing or controlling disease.^[13]

History[edit]

The word "nutraceutical" is a portmanteau of the words "nutrition" and "pharmaceutical", was coined in 1989 by Stephen L. DeFelice, founder and chairman of the Foundation of Innovation Medicine.^[14] Indians, Egyptians, Chinese, and Sumerians are just a few civilizations that have used food as medicine.^[15] “Let food be thy medicine.” is a common misquotation ^[16] attributed to Hippocrates, who is considered by some to be the father of Western medicine.

The modern nutraceutical market began to develop in Japan during the 1980s. In contrast to the natural herbs and spices used as folk medicine for centuries throughout Asia, the nutraceutical industry has grown alongside the expansion and exploration of modern technology.^[

pharmaceutical and biopharmaceutical

The primary difference between biopharmaceuticals and traditional pharmaceuticals is the method by which the drugs are produced: The former are manufactured in living organisms such as bacteria, yeast and mammalian cells, whereas the latter are manufactured through a series of chemical synthesis.

Drug & Medicine

Medicine, however, is our term for a drug when that drug is used to cure, mitigate, treat, or prevent a disease. Many people become addicted to drugs even when used as medicine. ... Here is where the lines of addiction and medicine become blurry and begin to come together until the medication is the addiction

Medicotherapeutic approach vs Pharmacotherapeutic approach

Therapeutics: In medicine, the branch that deals specifically with the treatment of disease and the art and science of healing. In pharmacology, therapeutics accordingly refers to the use of drugs and the method of their administration in the treatment of disease.

DEA number

A DEA number (DEA Registration Number) is an identifier assigned to a health care provider (such as a physician, optometrist, ], dentist, or veterinarian) by the United States Drug Enforcement Administration allowing them to write prescriptions for controlled substances.

After completion of Pharm D(PB) in India and after successfully passing entrance exam by CPC in India again, will the indian pharmacist is supposed to appear for entrance exam FPGEE /NAPLEX in USA, so as a DEA number is issued to him by USA ? 

Comedown drugs

Comedown or crashing is the deterioration in mood that happens as a psychoactive drug, typically a stimulant, is either decreasing or is cleared from the blood and thus the cerebral circulation. The improvement and deterioration of mood (euphoria and dysphoria) are represented in the cognitive schema as high and low elevations; thus, after the drug has elevated the mood (a state known as a high), there follows a period of coming back down, which often has a distinct character from withdrawal in stimulants. Generally, a comedown ("down", "low", sometimes "crash") can happen to anyone as a transient symptom, but in people who are dependent on the drug (especially those addicted to it), it is an early symptom of withdrawal and thus can be followed by others. Various drug classes, most especially stimulants and to a lesser degree opioids and sedatives, are subject to comedowns. A milder analogous mood cycle can happen even with blood sugar levels (thus sugar highs and sugar lows), which is especially relevant to people with diabetes mellitusand to parents and teachers managing children's behavior, as well as in adults with ADHD. Stimulant comedowns are unique in that they often appear very abruptly after a period of focus or high, and are typically the more intensely dysphoric phase of withdrawal than that following complete elimination from the bloodstream. Besides general dysphoria, this phase can be marked by frustration, anger, anhedonia, social withdrawal, and other symptoms characteristic to a milder mixed episode in bipolar disorder. Alertness and other general stimulant effects are still present.

prescription drug

A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

"Rx" (℞) is often used as a short form for prescription drug in North America- a contraction of the Latin word "recipe" (an imperative form of "recipere") meaning "take". Prescription drugs are often dispensed together with a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug.

The use of prescription drugs has been increasing since the 1960s. In the U.S., 88% of older adults (62–85 years) use at least 1 prescription drug, while 36% take at least 5 prescription medicines concurrently

Regulation

Australia

In Australia, the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) governs the manufacture and supply of drugs with several categories:

• Schedule 1 – Defunct
• Schedule 2 – Pharmacy Medicine
• Schedule 3 – Pharmacist-Only Medicine
• Schedule 4 – Prescription-Only Medicine/Prescription Animal Remedy
• Schedule 5 – Caution
• Schedule 6 – Poison
• Schedule 7 – Dangerous Poison
• Schedule 8 – Controlled Drug (Possession without authority illegal)
• Schedule 9 – Prohibited Substance
• Unscheduled Substances

Like in the UK, the patient visits a health practitioner, (doctor, nurse, dentist, podiatrist, etc.,), who may prescribe the drug.

Many prescriptions issued by health practitioners in Australia are covered by the Pharmaceutical Benefits Scheme, a scheme that provides subsidised prescription drugs to residents of Australia to ensure that all Australians have affordable and reliable access to a wide range of necessary medicines. When purchasing a drug under the PBS, the consumer pays no more than the patient co-payment contribution, which, as of January 1, 2017, is A$38.80 for general patients. Those covered by government entitlements (low-income earners, welfare recipients, Health Care Card holders, etc.) and or under the Repatriation Pharmaceutical Benefits Scheme (RPBS) have a reduced co-payment, which is $6.30 in 2017. The co-payments are compulsory and cannot be discounted by pharmacies under any circumstances.

Private prescriptions are issued for medicines that are not covered on the PBS or are used off-label, for indications other than those covered by the PBS. The patient pays the pharmacy for medicines that are privately prescribed.

United Kingdom

In the United Kingdom, the Medicines Act 1968 and the Prescription Only Medicines (Human Use) Order 1997 contain regulations that cover the supply of sale, use, prescribing and production of medicines. There are three categories of medicine:

• Prescription-only medicines (POM), which may be sold by a pharmacist if they are prescribed by a prescriber
• Pharmacy medicines (P), which may be sold by a pharmacist without a prescription
• General sales list (GSL) medicines, which may be sold without a prescription in any shop

The possession of a prescription-only medicine without a prescription is legal unless it is covered by the Misuse of Drugs Act 1971.

A patient visits a medical practitioner or dentist, who may prescribe drugs and certain other medical items, such as blood glucose-testing equipment for diabetics. Also, suitably-qualified and experienced nurses and pharmacists may be independent prescribers. Both may prescribe all POMs, but pharmacists may not prescribe Schedule 1 controlled drugs. District nurses and health visitors have had limited prescribing rights since the mid-1990s; until then, prescriptions for dressings and simple medicines had to be signed by a doctor. Once issued, a prescription is taken by the patient to a pharmacy, which dispenses the medicine.

Most prescriptions are NHS prescriptions, subject to a standard charge that is unrelated to what is dispensed. The NHS prescription fee was increased to £8.60 per item in Englandon 1 April 2017; prescriptions are free of charge if prescribed and dispensed in Scotland,Wales and Northern Ireland, and for some patients in England, such as inpatients, children, those over 60s or with certain medical conditions, and claimants of certain benefits.The pharmacy charges the NHS the actual cost of the medicine, which may vary from a few pence to hundreds of pounds. A patient can consolidate prescription charges by using a prescription payment certificate (informally a "season ticket"), effectively capping costs at £29.10 per quarter or £104.00 per year.

Outside the NHS, private prescriptions are issued by private medical practitioner and sometimes under the NHS for medicines that are not covered by the NHS. 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.

Survey results published by Ipsos MORI in 2008 found that around 800,000 people in England were not collecting prescriptions or getting them dispensed because of the cost, the same as in 2001.

United States

Regulation of therapeutic goods in the United States
Prescription drugs Over-the-counter drugs
Law[show]
Government agencies[show]
Process[show]
International coordination[show]
Non-governmental organizations[show]
v t e

In the United States, the Federal Food, Drug, and Cosmetic Act defines what substances require a prescription for them to be dispensed by a pharmacy. The federal government authorizes physicians, psychiatrists, physician assistants, nurse practitioners and other advanced practice nurses, veterinarians, dentists, and optometrists to prescribe any controlled substance. They are then issued unique Drug Enforcement Act numbers; many other mental and physical health technicians, including basic-level registered nurses, medical assistants, emergency medical technicians, most psychologists, and social workers, for example, do not have the authority to prescribe any controlled substance.

The Controlled Substances Act (CSA) was enacted into law by the US Congress of the United States in 1970. It is the federal drug law that regulates manufacture, importation, possession, use, and distribution of certain substances. The legislation classes substances into five schedules, with varying qualifications for each schedule.

The safety and the effectiveness of prescription drugs in the US are regulated by the 1987 Prescription Drug Marketing Act (PDMA). The Food and Drug Administration (FDA) is charged with implementing the law.

Misuse or abuse of prescription drugs can lead to adverse drug events, including those due to dangerous drug interactions. According to one study, as many as 15% of older American adults are at risk of potential major interactions between drugs.

The package insert for a prescription drug contains information about the intended effect of the drug and how it works in the body. It also contains information about side effects, how a patient should take the drug, and cautions for its use, including warnings about allergies.

As a general rule, over-the-counter drugs (OTC) are used to treat a condition that does not need care from a healthcare professional if have been proven to meet higher safety standards for self-medication by patients. Often, a lower strength of a drug will be approved for OTC use, but higher strengths require a prescription to be obtained; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid-1980s, but it is available by prescription in doses up to four times the OTC dose for severe pain that is not adequately controlled by the OTC strength.

Herbal preparations, amino acids, vitamins, minerals, and other food supplements are regulated by the FDA as dietary supplements. Because specific health claims cannot be made, the consumer must make informed decisions when purchasing such products.

By law, American pharmacies operated by "membership clubs" such as Costco and Sam's Club must allow non-members to use their pharmacy services and may not charge more for these services than they charge as their members.

Physicians may legally prescribe drugs for uses other than those specified in the FDA approval, known as off-label use. Drug companies, however, are prohibited from marketing their drugs for off-label uses.

Large US retailers that operate pharmacies and pharmacy chains use inexpensive generic drugs as a way to attract customers into stores. Several chains, including Walmart, Kroger (including subsidiaries such as Dillons), Target, and others, offer $4 monthly prescriptions on select generic drugs as a customer draw.^[16] Publix Supermarkets, which has pharmacies in many of their stores, offers free prescriptions on a few older but still effective medications to their customers. The maximum supply is for 30 days.

Many prescription drugs are commonly abused, particularly those marketed as analgesics, including fentanyl (Duragesic), hydrocodone (Vicodin), oxycodone (OxyContin), oxymorphone (Opana), propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine (Demerol), and diphenoxylate (Lomotil).

Prescription painkillers have been found to be extremely addictive, and unintentional poisoning deaths in the United States have skyrocketed since the 1990s. Prescriber education guidelines as well as patient education, prescription drug monitoring programs and regulation of pain clinics are regulatory tactics which have been used to curtail opioid use and misuse.

Expiration date

The expiration date, required in several countries, specifies the date up to which the manufacturer guarantees the full potency and safety of a drug. In the United States, expiration dates are determined by regulations established by the FDA. The FDA advises consumers not to use products after their expiration dates.

A study conducted by the U.S. Food and Drug Administration covered over 100 drugs, prescription and over-the-counter. The res Joel Davis, a former FDA expiration-date compliance chief, said that with a handful of exceptions—notably nitroglycerin, insulin, some liquid antibiotics; outdated tetracyclines can cause Fanconi syndrome—most expired drugs are probably effective.

The American Medical Association (AMA) issued a report and statement on Pharmaceutical Expiration Dates. The Harvard Medical School Family Health Guide notes that, with rare exceptions, "it's true the effectiveness of a drug may decrease over time, but much of the original potency still remains even a decade after the expiration date".

The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC) and dietary (herbal) supplements. U.S. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing. For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.

Cost

Prices for prescription drugs vary widely around the world. Prescription costs for biosimilar and generic drugs are usually less than brand names, but the cost is different from one pharmacy to another.

Prescription drug prices including generic prices are rising faster than the average rate of inflation. To subsidize prescription drug costs, some patients have decided to buy medicine online.

Environment

Traces of prescription drugs — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been detected in drinking water.

Premedication

Premedication is using medication before some other therapy (usually surgery or chemotherapy) to prepare for that forthcoming therapy. Typical examples include premedicating with a sedative or analgesic before surgery; using prophylactic (preventive) antibiotics before surgery; and using antiemetics or antihistamines before chemotherapy.

Premedication before chemotherapy for cancer often consists of drug regimens (usually 2 or more drugs, e.g. dexamethasone, diphenhydramine and omeprazole) given to a patient minutes to hours before the chemotherapy to avert side effects or hypersensitivity reactions (i.e. allergic reactions).

Melatonin has been found to be effective as a premedication in both adults and children due to its pharmacological properties of hypnotic, antinociceptive and anticonvulsant which produce effective anxiolosis and sedation. Unlike midazolam melatonin does not impair psychomotor skills or adversely affect the quality of recovery. It has a faster recovery time compared to midazolam and has a reduced incidence of post-operative excitement and results in a reduction in dose required of propofol and thiopental.

Midazolam is effective in children in reducing anxiety associated with separation from parents and induction of anesthesia. Sufentanil is also sometimes used as a premedication. Clonidine is becoming increasingly popular as a premedication for children. One drawback of clonidine is that it can take up to 45 minutes to take full effect. In children, clonidine has been found to be equal to and possibly superior to benzodiazepines as a premedication. It has a more favourable side effect profile. It also reduces the need for an inductionagent. It improves post-operative pain relief, is better at inducing sedation at induction, reduces agitated emergence, reduces shivering and post-operative nausea and vomiting and reduces post-operative delirium associated with sevoflurane anaesthesia. Benzodiazepines such as midazolam are more commonly used due largely to a lack of a marketing effort by the pharmaceutical companies. As a result, clonidine is becoming increasingly popular with anesthesiologists  . Dexmedetomidine and atypical antipsychotic agents are other premedications which are used particularly in very uncooperative children.

Non-drug interventions for children include playing relaxing music, massages, reducing noise and controlling light to maintain the sleep wake cycle. Other non-pharmacological options for children who refuse or cannot tolerate premedication include clown doctors; low sensory stimulation and hand-held video games may also help reduce anxiety during induction of general anesthesia.