ON LINE INTERNET PHARMACY OF GENERIC DRUGS

Kay Kay Healthcare Ltd.

Pharmacy and Internet:
Current Advances
Contact Person: Cristina J Buil (cristinajimenez@bootshealthcare.es)

Introduction The importance of Internet as a communication medium in biomedical sciences is a fact due to the amount of information it distributes. The appearance of virtual user communities (CMV) focuses to information classification within current issues of interest for certain groups of people in order to facilitate its search and use.

The UniNet project of Integrated Telematic Services for CMV through other subprojects tries the creation of CMV by mean of integration of various computer machines and Internet resources, as a distribution mailing list, web pages, Internet Relay Chat (IRC), etc.

The IRC is presented as an important scientific tool to the known as a professional real time comunication by Internet among people interested in biomedical sciences.

Within Internet there is information and communication. The interpersonal communication is moved from several ways and with differents velocity. Mode on deffering is: web pages, mailing list, personal e-mail, etc.

So we have to think that the comunication in real time exist and it is the fastest, Internet Relay Chat (IRC).

Videoconference, phonoconference are still on building.

IRC is a very useful tool of interpersonal communication, is very fast and effective. It allows talking with one or more people at the same time and in real time through textual format. Also we can interchange text files, images and sounds inmediately, thereby it gives a sensation of physical proximity. In this way we can speak with people at the same time and in different channels.

The idea is to use this wonderful tool in the Health profesional communities.

Role of IRC in Health Sciences

In Spain UniNet was created as a network based on universities and compatible servers, wich include internet relay chat channels (IRC) on thematic characteristics and scientific content .

UniNet is originated on an altruistic idea, born in the academic sphere, supported by different university institutions and made by means of many people's volunteer work. The contributions are improving to maintain, to growth and diffusion. These contibutions include suggestions, maintenance or creation of new channels, addition of channels, or other kinds of contributions.

UniNet is working continuosly to all the people interested in bioscienctific, cultural and humanistic activities, or Which are based on educational, student views, medical/technical assistance, investigative type etc.

It does not exist any linguistic, racial, ethnic, ideological, cultural or other kind of discrimination.

There are in this moment lot of channels about biosciences as pharmacy channel and biomedicine channel.

Biomedicine channel is the first channel created and the pioneerring for the rest of them.

Till now as much the physicians as pharmaceutics people were updated on the health news through the Bibliography, so it was a good way but sometimes very slow.

Certainly Internet has maked easy the interchange of communications among health professionals, not only the information into web pages and navigators, especially the Internet Relay Chat (IRC).

IRC offers infinites posibilities as interchange of opinions with people from differents and remotes countries, that in other way it would be more difficult, by mail is lower, by phone more expensive. IRC allows to knowing Sanitary Programs from other countries, how is working Health Service and novelties as much about research as about new drugs and overall it makes possible for talk with another foreing counterparts.

Training

IRC has a lot of aplications. For instance UniNet has a Scientific-IRC service by a net of university servers as a physic support with channels to relay chat of thematic charcter for each users groups. Within UniNet is doing trainig courses, I am going to explain the courses that we will able to give and as Inovative Pharmaceutical Company. Boots Healthcare Spain has sponsored this year from May to July a course Entitled: "Metodology in research with drugs". It was be done in colaboration with, European Agency for evaluation of Medicinal Products (E.M.E.A), University of Minnesota, Spanish Ministry of Health. http://bio.hgy.es/ec . Boots Healthcare (BH) collaborates with UniNet due to BH is very interested in biomedical research and all the thinks in relation with Healthcare Sciences.

Boots thinks is very important to give facilities to improve and support the new ways of of communication.

Boots healhcare Spain has a center of information by Internet To profesionals of health and user as well is "El Centro Nurofen del Dolor" http:///www.centronurofen.com Boots Healthcare is working about analgesis products (Boots Companny sintetized IBUPROFEN and this substance was introduced in Clinical practice in 1969).

We would like propose following Courses:
Within pharmacy channel and biomedicine chanel :

Pharmacoeconomy, Pharmacovigilance, Responsible Self-medication, OTC products, Trainning courses to pharmacyst and physicians, Any kind of pain (cephalea, backpain, migrain, dismenorrhea etc.) NAIDs Toxicity.

ASHP Policy Positions: Automation and Information Technology

ELECTRONIC HEALTH AND BUSINESS TECHNOLOGY AND SERVICES

To encourage pharmacists to assume a leadership role in their hospitals and health systems with respect to strategic planning for and implementation of electronic health and business technology and services; further,

To encourage hospital and health-system administrators to provide dedicated resources for pharmacy departments to design, implement, and maintain electronic health and business technology and services; further,

To advocate the inclusion of electronic health technology and telepharmacy issues and applications in college of pharmacy curricula.

ELECTRONIC INFORMATION SYSTEMS

To advocate the use of electronic information systems, with appropriate security controls, that enable the integration of patient-specific data that is accessible in all components of a health system; further,

To support the use of technology that allows the transfer of patient information needed for appropriate medication management across the continuum of care; further,

To urge computer software vendors and pharmaceutical suppliers to provide standards for definition, collection, coding, and exchange of clinical data used in the medication-use process; further,

To pursue formal and informal liaisons with appropriate health care associations to ensure that the interests of patient care and safety in the medication-use process are fully represented in the standardization, integration, and implementation of electronic information systems; further,

To strongly encourage health-system administrators, regulatory bodies, and other appropriate groups to provide health-system pharmacists with full access to patient-specific clinical data.

ONLINE PHARMACY AND INTERNET PRESCRIBING
Source: Council on Legal and Public Affairs

To support collaborative efforts of the Food and Drug Administration, the National Association of Boards of Pharmacy (NABP), and the Federation of State Medical Boards, as stated in the Principles of Understanding on the Sale of Drugs on the Internet, to regulate prescribing and dispensing of medications via the Internet; further,

To support legislation or regulation that requires pharmacy World Wide Web sites to list the states in which the pharmacy and pharmacists are licensed, and, if prescribing services are offered, requires that the sites
(1) ensure that a legitimate patient-prescriber relationship exists (consistent with professional practice standards) and
(2) list the states in which the prescribers are licensed; further,

To support mandatory accreditation by NABP of pharmacy Web sites and appropriate consumer education about the risks and benefits of using Internet pharmacies; further,

To support the principle that any medication distribution or drug therapy management system must provide timely access to, and interaction with, appropriate professional pharmacist patient-care
services.

This policy supersedes ASHP policy 0009.

PHARMACIST'S ROLE IN ELECTRONIC PATIENT INFORMATION AND PRESCRIBING SYSTEMS
Source: Council on Administrative Affairs

To strongly advocate key decision roles of pharmacists in the planning, selection, implementation, and maintenance of electronic patient information systems (including computerized prescriber order-entry systems) to facilitate clinical decision support, data analysis, and education of users for the purpose of ensuring the safe and effective use of medications.

This policy was reviewed in 2006 by the Council on Pharmacy Management and by the Board of Directors and was found to still be appropriate.

COMPUTERIZED PRESCRIBER ORDER ENTRY

Source: Council on Administrative Affairs

To advocate the use of computerized entry of medication orders or prescriptions by the prescriber when
(1) it is planned, implemented, and managed with pharmacists' involvement,
(2) such orders are part of a single, shared database that is fully integrated with the pharmacy information system and other key information system components, especially the patient's medication administration record,
(3) such computerized order entry improves the safety, efficiency, and accuracy of the medication-use process, and
(4) it includes provisions for the pharmacist to review and verify the order's appropriateness before medication administration, except in those instances when review would cause a medically unacceptable delay.

This policy was reviewed in 2005 by the Council on Administrative Affairs and by the Board of Directors and was found to still be appropriate.

TELEPHARMACY

Source: Council on Professional Affairs

To foster among health-system pharmacists and leaders of the telecommunications industry a common vision for the integration of telecommunication technology into the delivery of pharmaceutical care.

This policy was reviewed in 2003 by the Council on Professional Affairs and by the Board of Directors and was found to still be appropriate.

REGULATION OF AUTOMATED DRUG DISTRIBUTION SYSTEMS

Source: Council on Legal and Public Affairs

To work with the Drug Enforcement Administration and other agencies to seek regulatory and policy changes to accommodate automated drug distribution in health systems.

This policy was reviewed in 2007 by the Council on Public Policy and by the Board of Directors and was found to still be appropriate.

Pharmacy Pharmacy derives its name from the Greek root pharmakon, a drug. Pharmacy is concerned with the manufacture, formulation, quality control, and dispensing of medicaments used to treat disease. The majority of modern medicaments consist of tablets, capsules, and injections, all produced under stringent conditions. Usually only a tiny part of the product is active drug, the rest being the ‘excipient’ which provides an appropriate vehicle for delivery to the patient. Many old-fashioned forms of medication — such as mixtures, tinctures, decoctions, elixirs, emulsions, and syrups — have now virtually disappeared, reducing the requirement for extemporaneous manufacture of products by dispensing pharmacists. The Drugstore The nineteenth-century American drugstore carried a full line of simples (mainly crude vegetable drugs) and chemicals with which pharmacists compounded and dispensed medicines, with or without a prescription. They were artisans who spread their own plasters and prepared pills, powders, tinctures, ointments, syrups, conserves, medicated waters, and perfumes. Economic necessity forced them to handle such commodities as confections, tobacco, paints, glass, groceries, spices, and liquor. They were thus commonly also merchants, and pharmacists often differed among themselves as to whether theirs was a trade or a profession.

By the mid-nineteenth century this artisanal role of pharmacists had begun to diminish. A pharmaceutical industry was providing medicines that pharmacists had previously made entirely by hand. There was a burgeoning growth of proprietary ("patent") medicines, flamboyantly advertised, with which pharmacists had to deal. Economic competition from department stores, groceries, and chain stores added to the pressure. Late in the century the competition—including that among pharmacists, for the "cut-rate" pharmacy shop had become ubiquitous—led to a number of plans to fix prices, but both these plans and the fair trade statutes of the mid-twentieth century fell afoul of federal antitrust laws. One peculiarly American development was the drugstore soda fountain, which was an outcome of the pharmacist's knowledge of flavors and carbonated water. The pharmacist Elias Durand operated a soda fountain in his Philadelphia shop as early as 1825. American soft drinks, the colas particularly, had their beginnings in the drugstore. The soda fountain was not to disappear from the drugstore until the mid-twentieth century, when it gave way to more profitable alternative uses for the space.

Science and Technology The great scientific and technological advances in the medical and biological sciences in the late nineteenth century transformed pharmacy in a number of ways. First, the old materia medica—still showing evidence of ancient lineage—increasingly gave way to new medications based on a better scientific understanding of the etiology of diseases and of the mechanisms of drug action. These medications were the products of synthetic and medicinal chemistry, new powerful tools. Second, in the twentieth century these new medications were largely the discoveries and innovations of the rapidly developing pharmaceutical industry and, moreover, were the products of research and manufacture that the individual pharmacist could not duplicate. This meant that the compounding of medicines by the pharmacist gave way to the dispensing of medications completely prepared by industry. By the 1970s only one percent of prescriptions required some combination or manipulation of ingredients. Third, the sciences gave impetus to the separation of pharmaceutical practice from medical practice.

Pharmacy Law The training of the pharmacist was accomplished largely through the apprenticeship system and, in the absence of legal restrictions—a concomitant of Jacksonian democracy—it was possible for any persons to set themselves up as pharmacists. The first laws providing for the examination and licensing of pharmacists in an American jurisdiction were passed in Louisiana, where the Franco-Spanish tradition in pharmacy prevailed in regulations of the Territory of Orleans in 1808 and of the state in 1816. The few other such attempts before the Civil War, in three southern states and a few localities, were, in the prevailing democratic milieu, ineffectual.

Rhode Island passed the first modern state law for the examining and licensing of pharmacists in 1870. Pressure for such laws came from the American Pharmaceutical Association, founded in 1852, and from state and territorial pharmaceutical associations (of which there were forty-five and two, respectively, by 1900). As a consequence, forty-seven states had such laws by the end of the century. This legislation established state boards of pharmacy, composed originally of pharmacists. The boards, among other powers, examined candidates and imposed educational requirements that became more advanced as the colleges of pharmacy increased the depth and length of the pharmacy curricula. Following standards and accreditation requirements developed by the American Association of Colleges of Pharmacy (founded in 1900) and by the American Council on Pharmaceutical Education (founded in 1932), these curricula increased from two and three-year Graduate in Pharmacy (Ph.G.) and Pharmaceutical Chemist (Ph.C.) programs, to four-and five-year baccalaureate programs, and to six–year Doctor of Pharmacy (Pharm.D.) programs. In 1999 over 45 percent of all the pharmacy graduates in the country received the Pharm.D. degree as their first professional degree.

Under the American constitutional system it was state law that regulated pharmacy and imposed restrictions on the sales of poisons and abortifacients. The federal government first became involved in the regulation of pharmacy with the Pure Food and Drug Act of 1906. That legislation and its principal amendments (1912, 1938, 1952, and 1962) and the Harrison Narcotic Act of 1914 set the stage for what became the very close federal involvement in the control of drugs. "Legend drugs, " requiring a physician's prescription, and a list of "controlled dangerous substances" made the pharmacist subject to federal, as well as state, authority. Pharmaceutical Education

Pharmaceutical education began in the United States with the founding of the Philadelphia College of Pharmacy (now the University of the Sciences in Philadelphia) in 1821.

The term"college" was intended at first to suggest only a society rather than a school, but the Philadelphia College offered lectures almost from the start. Local societies of pharmacy, also calling themselves colleges, were formed in Boston, New York City, Baltimore, Cincinnati, Chicago, and St. Louis, and all of them sooner or later engaged in pharmaceutical instruction. By 1900 about sixty programs were or had been in operation. The program of instruction in these institutions, especially in the good number that were private and proprietary, was indeed meager, consisting mainly of a series of lectures in the evening in rented rooms.

In 1868 the University of Michigan embarked upon a full program of scientific training in pharmacy, eventually developing a full-time, day program of two years. The University of Wisconsin followed suit in 1883 and nine years later it pioneered in offering a four-year program leading to a bachelor's degree. As noted, the length and the curricular requirements took off from there, reflecting new developments in the pharmaceutical sciences and the changing professional role of the pharmacist, both in and beyond the drugstore. The curriculum changes demanded by the doctorate included more attention to the humanities and emphasized clinical pharmacy and relatively new sciences like pharmacokinetics and pharmacotherapeutics. Externship programs in community, industrial, hospital, and clinical pharmacy became part of the curriculum.

The Changing Role of the Pharmacist The plethora of new and complex medicines that industry was providing, along with the increasing demands for prescription drugs as the population aged, meant that pharmacists who dealt directly with the patient needed to be more than just artisans who compounded or dispensed drugs. Limited in their freedom of activity by the introduction of Medicaid and Medicare, the new managed care systems, and computerization, pharmacists found that their choice of drugs and their prices were no longer under their control. The pharmacist assumed a new, consultative role in health-care delivery that demanded knowledge of the drugs and their action in the body and the monitoring of the drugregimen of the patients.

The responsibility of the pharmacist in providing correct and effective medication and in preventing errors was evident in the great expansion of pharmacists into the health field beyond the drugstore. Hospital pharmacy goes back in the United States to before the Revolution; by 1942 hospital pharmacists had become so significant a part of the heath-care community that they formed the American Society of Hospital Pharmacists. As the twentieth century progressed, the practice of clinical pharmacy developed. In clinical pharmacy the pharmacist is responsible in a hospital situation for cooperating with the physician in monitoring the prescribed medications. Clinical and consulting pharmacists also are involved in other institutions, such as nursing homes and assisted living quarters. In recognition of the broader role of clinical and consultative pharmacy, the American Society of Hospital Pharmacists became the American Society of Health System Pharmacists in 1995.

Demographics and Infrastructure

The demography of pharmacy personnel changed quite rapidly in the late twentieth century. Beginning in 1985, more than half of each year's pharmaceutical degree recipients were women. In 1999 women graduates made up 63.5 percent of the total. The ethnicity of personnel was also changing. The percentage of white graduates fell from 86 percent in 1979 to 64 percent in 1999, while the percentage of Asian, Native Hawaiian, and Pacific Islanders rose from under 4 percent to over 18 percent in the same period. African Americans rose from 3.6 percent to 5.6 percent; Hispanics and Latinos declined from 3.8 percent to 3.7 percent.

The last decade of the twentieth century saw a drop in the total number of drugstore outlets from 58,642 in 1990 to 53,105 in 1999. The decline, however, was only among independent pharmacies. They went from 31,879 to 20,649, a decrease of 11,230 units in the decade. Chain stores, supermarket units, and mass merchandiser units all increased in number. One factor in the decline of independent pharmacies was the development of Pharmacy Benefit Management organizations (PBMs) and the accompanying growth of mail-order prescription services.

At the end of the twentieth century the National Community Pharmacists Association (founded as the National Association of Retail Druggists in 1898) still had a membership of 25,000. The American Society of Health-System Pharmacists had an equal number of members. Pharmacy had developed in two directions.

Generic Vs. Patented Generic Drugs

A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient.

A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA's use of the word identical is very much a legal interpretation, and is not literal. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

Economics Generic drugs can save patients and insurance companies substantial costs. The principal reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents. Companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them. For example Thailand is going to import millions of doses of the generic version of Plavix, a blood-thinning treatment to prevent heart attacks, at a cost of 3 US cents per dose from India, the leading manufacturer of generic drugs.

Generic manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. (See the Approval and regulation section, below, for more information about the approval process.) It has been estimated that the average cost to brand-name drug companies of discovering and testing a new innovative drug (with a new chemical entity) may be as much as $800 million. However that figure is disputed in Merril Goozner's book the $800 Million Dollar Pill. Goozner estimates that the true cost of bringing a new drug to market is closer to $100-$200 million.

Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples. Many of the drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well-known to patients and providers (although often under their branded name).

For as long as a drug patent lasts, a brand name company enjoys a period of “market exclusivity” or monopoly, in which the company is able to set the price of the drug at a level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development, thus enabling them to fund the research and development of new medicines which most generic companies cannot afford to do. The advantage of generic drugs to consumers comes in the introduction of competition, which prevents any single company from dictating the overall market price of the drug. Competition is also seen between generic and name-brand drugs with similar therapeutic uses when physicians or health plans adopt policies of preferentially prescribing generic drugs as in step therapy. With multiple firms producing the generic version of a drug the profit-maximizing price generally falls to the ongoing cost of producing the drug, which is usually much lower than the monopoly price.

The FDA gives a list of 10 non-proprietary drug names (non IUPAC) for the developing drug company to choose from and 10 brand names for the company to choose from.[citation needed] It is in the best interest of the company to choose a brand name that is easy to remember and a non-proprietary drug name which is difficult to remember. (eg. 7-chloro-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one has a brand name of Valium, and a non-proprietary name of diazepam)

Patent issues When can a generic drug be produced? When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it. Generic drugs can be legally produced for drugs where:
1) the patent has expired,
2) the generic company certifies the brand company's patents are either invalid, unenforceable or will not be infringed,

3) for drugs which have never held patents, or
4) in countries where a patent(s) is/are not in force.[citation needed] The expiration of a patent removes the monopoly of the patent holder on drug sales licensing. Patent lifetime differs from country to country, and typically there is no way to renew a patent after it expires.[citation needed.A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials. In addition, a patent on a changed compound does not prevent sales of the generic versions of the original drug unless regulators take the original drug off the market.

This allows the company to recoup the cost of developing that particular drug. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.

Challenging Patents Brand-name drug companies have used a number of strategies to extend the period of market exclusivity on their drugs, and prevent generic competition. This may involve aggressive litigation to preserve or extend patent protection on their medicines, a process referred to by critics as “evergreening”. Patents are typically issued on novel pharmacological compounds quite early in the drug development process, at which time the ‘clock’ to patent expiration begins ticking.

Later in the process, drug companies may seek new patents on the production of specific forms of these compounds, such as single enantiomers of drugs which can exist in both “left-handed” and “right-handed” forms, different inactive components in a drug salt, or a specific hydrate form of the drug salt. If granted, these patents ‘reset the clock’ on patent expiration. These sorts of patents may later be targeted for invalidation (“paragraph IV certification”) by generic drug manufacturers.

Generic Drug Exclusivity The U.S. Food and Drug Administration offers a 180 day exclusivity period to generic drug manufacturers in specific cases. During this period only one (or sometimes a few) generic manufacturers can produce the generic version of a drug. This exclusivity period is only used when a generic manufacturer argues that a patent is invalid or is not violated in the generic production of a drug, and the period acts as a reward for the generic manufacturer who is willing to risk liability in court and the cost of patent court litigation. There is often contention around these 180 day exclusivity periods because a generic producer does not have to produce the drug during this period and can file an application first to prevent other generic producers from selling the drug.

Recently, the purpose of the exclusivity "bonus" provided for by the Hatch-Waxman Amendments was turned on its head when the original patent holder, Cephalon, instituted patent infringement suit against all companies holding generic exclusivity rights to manufacture modafinil, the generic name for Cephalon's still-profitable stimulant drug, Provigil. "Settlement" of this suit with Cephalon was hardly a risky endeavor for the generic manufacturers, as it was Cephalon which agreed to pay Provigil's alleged infringers in excess of a billion dollars – if they agreed not to market generics for Provigil during their period of exclusivity. In effect, Cephalon was able to extend its exclusive right to manufacture Provigil even though Cephalon's patent for Provigil had already run out.[citation needed]

Large pharmaceutical companies often spend millions of dollars protecting their patents from generic competition.[citation needed] Apart from litigation, companies use other methods such as reformulation or licensing a subsidiary (or another company) to sell generics under the original patent. Generics sold under license from the patent holder are known as authorized generics; they are not affected by the 180 day exclusivity period as they fall under the patent holder's original drug application.

A prime example of how this works is simvastatin (Zocor), a popular drug created and manufactured by U.S. based pharmaceutical Merck & Co., which lost its US patent protection on June 23, 2006. India-based Ranbaxy Laboratories (at the 80 mg strength) and Israel-based Teva Pharmaceutical Industries (at all other strengths) received 180 day exclusivity periods for simvastatin; due to Zocor's popularity, both companies began marketing their products immediately after the patent expired. However, Dr. Reddy's Laboratories also markets an authorized generic version of simvastatin under license from Zocor's manufacturer, Merck & Co.; some packages of Dr. Reddy's simvastatin even show Merck as the actual manufacturer and have Merck's logo on the bottom.

Approval and Regulation Ensuring Bioequivalence Most nations require generic drug manufacturers to prove that their formulation exhibits bioequivalence to the innovator product. In the U.S., the FDA must approve generic drugs just as innovator drugs must be approved.[citation needed] The FDA requires the bioequivalence of the generic product to be between 80% and 125% of that of the innovator product. Bioequivalence, however, does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their innovator product counterparts, as chemical differences may exist (different salt or ester – a “pharmaceutical alternative”).

A physician survey in the US found that only 17% of prescribing physicians correctly identified the USFDA's standards for bioequivalency of generic drugs.A latest development to address this issue enables interested doctors and consumers to check generic drug interactions and outcomes detail to the specific drug and drug company.

The generic equivalent of name-brand warfarin has only been available under the trade name Coumadin in North America until recently. Warfarin (either under the trade name or the generic equivalent) 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 the Canadian province of Ontario showed that replacing Coumadin with generic warfarin was considered safe. In spite of the study, many physicians are not comfortable in allowing their patients to take the branded generic equivalent agents. As such, in countries such as Australia where warfarin is prescribed under more than one brandname (Marevan in 1 mg, 3 mg, 5 mg respectively and Coumadin in 1 mg, 2 mg, 5 mg respectively), the pharmacist may not substitute brandnames.

U.S. Generics Approval Process Enacted in 1984, the U.S. Drug Price Competition and Patent Term Restoration Act, informally known as the “Hatch-Waxman Act”, standardized U.S. procedures for recognition of generic drugs. An applicant files an Abbreviated New Drug Application (or “ANDA”) with the Food and Drug Administration (FDA) and seeks to demonstrate therapeutic equivalence to a specified, previously approved “reference listed drug”. When an ANDA is approved, the FDA adds the drug to its Approved Drug Products list, also known as the “Orange Book”, and annotates the list to show equivalence between the reference listed drug and the approved generic. The FDA also recognizes drugs using the same ingredients with different bioavailability and divides them into therapeutic equivalence groups. For example, as of 2006, diltiazem hydrochloride had four equivalence groups all using the same active ingredient but considered equivalent only within a group.

On October 4, 2007, FDA launched the Generic Initiative for Value and Efficiency, or GIVE. The initiative will use existing resources to help FDA modernize and streamline the generic drug approval process.

GIVE aims to increase the number and variety of generic drug products available. Having more generic-drug options means more cost-savings to consumers, as generic drugs cost about 30 percent to 80 percent less than brand name drugs.

In the United States, generic drug substances are named through review and recommendation of the United States Adopted Names (USAN) Council.