Instruct: Given a question, retrieve documents that can help answer the question.
Query: What's the difference between generic medication and name brand?
Before a company can market a generic drug, it needs to file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration, seeking to demonstrate therapeutic equivalence to a previously approved "reference-listed drug" and proving that it can manufacture the drug safely and consistently. For an ANDA to be approved, the FDA requires the bioequivalence of a generic drug to be between 80% and 125% of the innovator product. (This range is part of a statistical calculation, and does not mean that generic drugs are allowed to differ from their brand-name counterparts by up to 25 percent.) The FDA evaluated 2,070 studies conducted between 1996 and 2007 that compared the absorption of brand-name and generic drugs into a person's body. The average difference in absorption between the generic and the brand-name drug was 3.5 percent, comparable to the difference between two batches of a brand-name drug. Non-innovator versions of biologic drugs, or biosimilars, require clinical trials for immunogenicity in addition to tests establishing bioequivalency. These products cannot be entirely identical because of batch-to-batch variability and their biological nature, and they are subject to extra rules.
Certain medications listed on the PBS are available only for specific therapeutic indications or to patients meeting specific criteria where the PBAC has deemed that the cost-benefit analysis is favourable only in those indications/patients. These are noted as "restricted benefits" on the Schedule. Medicare Australia places the onus of policing restricted benefits on the prescribers themselves and the pharmacists dispensing (unless the listing is also 'Authority Required'). For example, the COX-2 inhibitor celecoxib is listed on the PBS as a restricted benefit for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. Prescribers using celecoxib for other indications are expected to indicate "non-PBS" on the prescription, and/or the pharmacist dispensing the celecoxib should charge the patient the full cost.
However, Sterling Products did not market "Panadol" in the United States or other countries where "Bayer Aspirin" still dominated the aspirin market. Other firms began selling acetaminophen drugs, most significantly, McNeil Laboratories with liquid "Tylenol" in 1955, and "Tylenol" pills in 1958. By 1967, "Tylenol" was available without a prescription. Because it did not cause gastric irritation, acetaminophen rapidly displaced much of aspirin's sales. Another analgesic, anti-inflammatory drug was introduced in 1962: ibuprofen (sold as "Brufen" in the U.K. and "Motrin" in the U.S.). By the 1970s, aspirin had a relatively small portion of the pain reliever market, and in the 1980s sales decreased even more when ibuprofen became available without prescription.
On January 15, 2010, Johnson & Johnson announced a voluntary recall of several hundred batches of popular medicines, including Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol. The recall was due to complaints of a musty smell suspected to be due to contamination of the packaging with the chemical 2,4,6-tribromoanisole. The full health effects of 2,4,6-tribromoanisole are not known but no serious events have been documented in medical literature. The recall came 20 months after McNeil first began receiving and investigating consumer complaints about moldy-smelling bottles of Tylenol Arthritis Relief caplets, according to the United States Food and Drug Administration (FDA). The recall included 53 million bottles of over-the-counter products including Tylenol, Motrin and Rolaids, Benadryl and St. Joseph's Aspirin, involving lots in the Americas, the United Arab Emirates and Fiji.
Canada (with the exception of the province of Quebec) is one of the few countries with a universal healthcare system that does not include coverage of prescription medication (other such countries are Russia and some of the former USSR republics even though Russia is considering a switch to full coverage of many prescription medications in the near future). Residents of Quebec who are covered by the province's public prescription drug plan pay an annual premium of $0 to $660 when they file their Quebec income tax return. Pharmaceutical medications are covered by public funds in some provinces for the elderly or indigent, or through employment-based private insurance or paid for out-of-pocket. Most drug prices are negotiated with suppliers by each provincial government to control costs but more recently, the Council of the Federation announced an initiative for select provinces to work together to create a larger buying block for more leverage to control costs of pharmaceutical drugs. More than 60 percent of prescription medications are paid for privately in Canada. Family physicians (often known as general practitioners or GPs in Canada) are chosen by individuals. If a patient wishes to see a specialist or is counselled to see a specialist by their GP, a referral is made by a GP in the local community. Preventive care and early detection are considered critical and yearly checkups are recommended for everyone.
On February 3, 2015 New York-based Pfizer's drug Ibrance was approved through the FDA's Breakthrough Therapy designation program as a treatment for advanced breast cancer. It can only be ordered through specialty pharmacies and sells for "$9,850 for a month or $118,200 per year". According to a statement by the New York-based Pfizer the price "is not the cost that most patients or payors pay" since most prescriptions are dispensed through health plans, which negotiate discounts for medicines or get government-mandated price concessions.
As an alternative to taking prescription drugs, some evidence shows that an average person seeking short-term help may find relief by taking over-the-counter antihistamines such as diphenhydramine or doxylamine. Diphenhydramine and doxylamine are widely used in nonprescription sleep aids. They are the most effective over-the-counter sedatives currently available, at least in much of Europe, Canada, Australia, and the United States, and are more sedating than some prescription hypnotics. Antihistamine effectiveness for sleep may decrease over time, and anticholinergic side-effects (such as dry mouth) may also be a drawback with these particular drugs. While addiction does not seem to be an issue with this class of drugs, they can induce dependence and rebound effects upon abrupt cessation of use. However, people whose insomnia is caused by restless legs syndrome may have worsened symptoms with antihistamines.
Many over-the-counter and prescription-only medications contain paracetamol. Because of its wide availability paired with comparably high toxicity, (compared to ibuprofen and aspirin) there is a much higher potential for overdose. Paracetamol toxicity is one of the most common causes of poisoning worldwide. In the United States, the United Kingdom, Australia, and New Zealand, paracetamol is the most common cause of drug overdoses. Additionally, in both the United States and the United Kingdom it is the most common cause of acute liver failure.
There are two major medications derived from methylphenidate's isomers: a racemic mixture of half d-threo-methylphenidate and half l-threo-methylphenidate called methylphenidate (Ritalin, Concerta), and an enantiopure formulation containing just d-threo-methylphenidate called dexmethylphenidate (Focalin).
In 1991 the FDA approved the first version of Genzyme's orphan drug Alglucerase (brand name Ceredase), the only treatment for Gaucher's disease. At that time, according to Genzyme CEO Henri Termeer — a pioneer in the biotechnology industry business model — one treatment of Ceredase for one patient took 22,000 placentas annually to manufacture, a difficult and expensive procedure. A new version of Ceredase, called Cerezyme, Imiglucerase which Genzyme produced in 1994 using genetically modified cells in vitro, was cheaper and easier to produce, was approved in several countries. In 2005 there were only about 4,500 patients on Cerezyme. In marketing imiglucerase, Termeer introduced the innovative and successful business strategy that became a model for the biotechnology or life sciences industry in general and specialty pharmacy in particular. Genzyme's added revenue from profits on the highly priced orphan or specialty drugs like imiglucerase, which had no competition, was used to undertake research and development for other drugs and to allow them to fund programs that distribute a small portion of production for free. In 2005 he then created what would eventually become a feature service of specialty pharmacy, by hiring 34 people to help patients acquire insurance plans that would cover the cost of their drugs. By 2005 although Cerezyme cost the average patient (including babies) $200,000 a year, it could cost a single adult patient as much as $520,000 a year even though it cost Genzyme less than $52,000 to manufacture, because the alternative is severe debilitation and early death. In 2005 there were only about 4,500 patients on Cerezyme.
H-antihistamines are among first-line therapy to treat gastrointestinal conditions including peptic ulcers and gastroesophageal reflux disease. Some formulations are available over the counter. Most side effects are due to cross-reactivity with unintended receptors. Cimetidine, for example, is notorious for antagonizing androgenic testosterone and DHT receptors at high doses.
Estradiol is also widely available in combination with progestogens. It is available in combination with norethisterone acetate under the major brand names Activelle, Cliane, Estalis, Eviana, Evorel Conti, Evorel Sequi, Kliogest, Novofem, Sequidot, and Trisequens; with drospirenone as Angeliq; with dydrogesterone as Femoston, Femoston Conti; and with nomegestrol acetate as Zoely. Estradiol valerate is available with cyproterone acetate as Climen; with dienogest as Climodien and Qlaira; with norgestrel as Cyclo-Progynova and Progyluton; with levonorgestrel as Klimonorm; with medroxyprogesterone acetate as Divina and Indivina; and with norethisterone enantate as Mesigyna and Mesygest. Estradiol cypionate is available with medroxyprogesterone acetate as Cyclo-Provera, Cyclofem, Feminena, Lunelle, and Novafem; estradiol enantate with algestone acetophenide as Deladroxate and Topasel; and estradiol benzoate is marketed with progesterone as Mestrolar and Nomestrol.
Several antiviral drugs are effective for treating herpes, including aciclovir (acyclovir), valaciclovir, famciclovir, and penciclovir. Aciclovir was the first discovered and is now available in generic. Valaciclovir is also available as a generic and is slightly more effective than aciclovir for reducing lesion healing time.
Corticosteroids (cortisone), accutane (isotretinoin) and other vitamin A derivatives, barbiturates, certain antibiotics, propofol, volatile anesthetics, non-depolarizing muscle relaxants, some local anesthetics, statins, fibrates, glitazones, beta blockers, biguanides, amiodarone, some chemotherapies, some neuroleptics, nucleoside reverse transcriptase inhibitors and various other drugs.
As a result of the crisis, all Tylenol capsules were discontinued, as were capsules of other brand names. Retained by McNeil's president, Joseph Chiesa, new product consultant Martin Calle of management strategist Calle & Company conceived the world's first tamper-resistant gelatin-enrobed capsule called "Tylenol Gelcaps", which proved to resuscitate the 92% of capsule-segment sales lost to the recall. The tamper-resistant, triple-sealed safety containers were placed on the shelves of retailers 10 weeks after the withdrawal, and other manufacturers followed suit. The crisis cost the company more than $100 million, but Tylenol regained 100% of the market share it had before the crisis. The Tylenol murderer was never found, and a $100,000 reward offered by Johnson & Johnson remains unclaimed.
Most studies of antihistamines reported on people who are younger, so the effects on people over age 65 are not as well understood. Older people are more likely to experience drowsiness from antihistamine use than younger people. Also, most of the research has been on white people and other ethnicities are not as represented in the research. The evidence does not report how antihistamines affect women differently than men. Different studies have reported on antihistamine use in children, with various studies finding evidence that certain antihistamines could be used by children 2 years of age, and other drugs being safer for younger or older children.
The level of regulation includes Schedule IV Non-Narcotic (depressant) (ACSCN 2285) in the United States under the Controlled Substances Act 1970—but along with a few other barbiturates and at least one benzodiazepine, and codeine, dionine, or dihydrocodeine at low concentrations, it also has exempt prescription and had at least one exempt OTC combination drug now more tightly regulated for its ephedrine content. The phenobarbitone/phenobarbital exists in subtherapeutic doses which add up to an effective dose to counter the overstimulation and possible seizures from a deliberate overdose in ephedrine tablets for asthma, which are now regulated at the federal and state level as: a restricted OTC medicine and/or watched precursor, uncontrolled but watched/restricted prescription drug & watched precursor, a Schedule II, III, IV, or V prescription-only controlled substance & watched precursor, or a Schedule V (which also has possible regulations at the county/parish, town, city, or district as well aside from the fact that the pharmacist can also choose not to sell it, and photo ID and signing a register is required) exempt Non-Narcotic restricted/watched OTC medicine.
Antihistamines are drugs which treat allergic rhinitis and other allergies. Antihistamines can give relief when a person has nasal congestion, sneezing, or hives because of pollen, dust mites, or animal allergy. Typically people take antihistamines as an inexpensive, generic, over-the-counter drug with few side effects. As an alternative to taking an antihistamine, people who suffer from allergies can instead avoid the substance which irritates them. However, this is not always possible as some substances, such as pollen, are carried in the air, thus making allergic reactions caused by them generally unavoidable. Antihistamines are usually for short-term treatment. Chronic allergies increase the risk of health problems which antihistamines might not treat, including asthma, sinusitis, and lower respiratory tract infection. Doctors recommend that people talk to them before any longer term use of antihistamines.
NHS England is supporting initiatives to place pharmacists in GP practices in order to improve the management of medication for patients with long term conditions. About 420 million repeat prescriptions are generated in the UK each year — about 200 for each general practitioner each week. In the practice pharmacists can do more Medicine use reviews. By April 2017 there were plans for 1350 practices in England to have access to clinical pharmacists. It is intended to have 1,500 pharmacists in general practice by 2020. NHS England’s announced funding for 180 pharmacists and 60 technicians to work in care homes in March 2018. The cost of medicines in primary care in England in 2017/2018 was £8.87 billion, slightly less than the previous year.
Not much published research exists which compares the efficacy and safety of the various antihistamines available. The research which does exist are mostly short term studies or studies which look at too few people to make general assumptions. Another gap in the research is in information reporting the health effects for individuals with long term allergies to take antihistamines for a long period of time. Newer antihistamines have been demonstrated to be effective in treating hives. However, there is not research comparing the relative efficacy of these drugs.
Progestins in birth control pills are sometimes grouped by generation. While the 19-nortestosterone progestins are consistently grouped into generations, the pregnane progestins that are or have been used in birth control pills are typically omitted from such classifications or are grouped simply as "miscellaneous" or "pregnanes". In any case, CPA has been described as a "first-generation" progestin similarly to closely related progestins like chlormadinone acetate, medroxyprogesterone acetate, and megestrol acetate.
A rational drug policy is one based on drug use in which patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community. Pharmaceutical companies make considerable money by selling drugs under their trade names, promoting the branded drugs as against those named generically. Doctors often prescribe branded drugs which are more expensive than generic drugs which have the same efficacy.
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 normal patient contribution if they decline to purchase the generic brand. The Brand Premium paid does not count toward either safety net threshold and must still be paid even after the threshold is reached.
Some generic drugs are viewed with suspicion by doctors. For example, warfarin (Coumadin) has a narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in Ontario showed that replacing Coumadin with generic warfarin was safe, but many physicians are not comfortable with their patients taking branded generic equivalents. In some countries (for example, Australia) where a drug is prescribed under more than one brand name, doctors may choose not to allow pharmacists to substitute a brand different from the one prescribed unless the consumer requests it.
Having unambiguous standard names for each drug (standardization of drug nomenclature) is important because a drug may be sold by many different brand names, or a branded medication may contain more than one drug. For example, the branded medications Celexa, Celapram and Citrol all contain the same active ingredient: citalopram; and the branded preparation Lemsip contains two active ingredients: paracetamol and phenylephrine.