Spending five years building a highly communicative, aesthetically beautiful brand name, on the other hand, will only get more difficult in the years ahead. Because the FDA requires all medicine names to be distinct in appearance and sound, each new drug that enters the market diminishes the linguistic space available for the following drug. In this competitive sector, it’s becoming more and more tempting to rely on quick and easy computer-generated names.
Some doctors and pharmacists are concerned that, as drug names get more complicated and less obvious, more drugs are slipping past the FDA’s regulatory cracks.
Despite the fact that the administration has the ability to scare pharmaceutical corporations (and their stockholders), it occasionally lets slip some names that look and sound alike. Consider the pharmaceuticals Zantac and Xanax, Paxil and Plavix, Neulasta and Lunesta. Those three sets of drugs are all on a list of pharmaceuticals that doctors and pharmacists have identified as being interchangeable. The Institute for Safe Medication Practices put together an eight-page list.
Do pharmaceutical businesses thrive during a downturn?
Surprisingly, the stock values of some biopharmaceutical companies, including Amgen, did well during the Great Recession. Other significant corporations, such as Pfizer and Bristol-Myers Squibb, had sales increase by 7% and 8%, respectively, in 2009.
Nonetheless, in 2008 and 2009, the compound annual growth rate of R&D spending in the biopharmaceutical business fell precipitously. In absolute terms, the sector also put less money into research and development.
What process do they use to name prescriptions?
The United States Adopted Names Program has assigned generic (nonproprietary) names to all active pharmaceutical components sold in the United States since the 1960s. Pharmaceutical names are assigned using a system in which specific syllables in the medication name (referred to as stems) transmit information about the medicine’s chemical structure, action, or indication. The name also includes a unique prefix that is euphonious, memorable, and acceptable to the sponsoring pharmaceutical company. The requirements and wishes of many stakeholders (patients, pharmaceutical firms, physicians, pharmacists, other health care professionals, and US and foreign regulators) must be balanced in the development of drug names.
Overview of Generic Naming
The assigning of generic names to pharmaceuticals in development is a necessary step before a drug may be marketed. The United States Adopted Names (USAN) Program, which assigns generic (nonproprietary) names to all active drug ingredients in the US, is the result of a long-standing collaboration between the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), and the American Pharmacists Association (APhA). The sponsoring partners are these three organizations, who get funding from the US Food and Drug Administration (FDA).
The FDA recognizes the USAN as the legal name for the active drug ingredient in the United States, and the USAN appears in the titles of USP monographs that specify the standards, attributes, and features of marketed medications. A medicine cannot be marketed in the United States without a USAN, with a few exceptions (for example, preventive vaccinations and mixes not named by the USAN Council). As a result, assigning a USAN is a mandatory step in drug development before a drug can be brought to the US market, and assigning a USAN is required for a new drug before it can be made available to patients.
The World Health Organization (WHO) publishes suggested International Nonproprietary Names (INN) for active pharmaceutical ingredients outside of the United States, however the INN is not a substitute for a USAN. The USAN and INN programs collaborate to guarantee that generic names are consistent both inside and outside the US. As a result, generic names differ very seldom within and outside the United States, yet these variances might be significant. The compound recognized as acetaminophen in the United States and paracetamol internationally1,2 is an example of a medicine with two names, despite the fact that these two names predate the establishment of the USAN Program.
When a medicine is in phase I or phase II clinical trials, companies normally start the process of obtaining a nonproprietary name by submitting a request to the USAN Program or the WHO. Most people like to finish their generic name assignments before they start writing papers about the drug, so they can use the name instead of a manufacturer code in their publications. Before engaging in premarketing labeling negotiations with the FDA, the USAN must be assigned.
Patient safety, easing communication between health care providers and patients, and access to prescription pharmaceuticals are all priorities for the USAN Council. As a result, the USAN Council recognizes the necessity of coining names that will not be confused with other medication names, threaten patient safety, or mislead health care professionals and patients about a new drug substance’s action or use. When it comes to nomenclature decisions, the USAN Council must balance the likelihood that high drug costs will limit patients’ access to them versus the possibility that pharmaceutical companies will choose not to produce drugs that they believe will not be profitable. Because the USAN name contains information about a medicine’s structure, activity, or intended use, it has the potential to influence how physicians, pharmacists, pharmacy benefit managers, and the investment community interpret the drug. These impressions can have an impact on medicine pricing and the drugs that corporations choose to pursue in clinical trials.
USAN Program History
The USAN Program arose from the American Medical Association’s Council on Pharmacy and Chemistry, which was established in 1905 to assess pharmaceuticals and combat quackery in medicine. 3 The Food, Drug, and Cosmetic Act of 1938 established federal regulatory authority over drugs, including the requirement for proof of safety4, but the American Medical Association’s Council on Pharmacy and Chemistry (renamed the Council on Drugs in 19575) continued to evaluate drugs, and the AMA had laboratory facilities for this purpose. The American Medical Association (AMA) produced an annual volume called New and Nonofficial Remedies (NNR) from 1907 to 1964, which was renamed New and Nonofficial Drugs (NND) in 1958. Between 1907 and 1955, the AMA issued Epitome of the United States Pharmacopeia and National Formulary yearly. 3 Drugs were included by name in both AMA publications, along with information regarding their qualities, use, and efficacy. In the aftermath of the thalidomide catastrophe, the Food, Medicine, and Cosmetic Act was changed in 1962 to give the FDA the ability to approveor not approvea drug based on proof of efficacy as well as safety. 6 Following the passage of this law, the AMA continued to disseminate medication information.
The American Medical Association’s Council on Drugs did not take the view that drugs should be labeled so that patients know what they were taking until 1963, and when it did, it stated that patients should not always be informed what was in their meds.
7 Patients should not know the identification of their medicines in some situations, including when they are taking opioids or barbituates, when they might try to “out-guess the doctor” and make decisions for themselves, or when they regard pharmaceuticals as “magical potions.” The Council advocated for drug labeling as a general practice, but suggested that prescription pads include boxes for “yes” or “no” to indicate whether the drug should be labeled, with labeling as the default.
Meanwhile, the AMA’s eventual USAN partners were working on their own nomenclature projects. The National Formulary was first published in 1888 by the American Pharmaceutical Association, afterwards renamed APhA. 8 The Pure Food and Drug Act of 1906 tasked the USP, which was founded in 1900, with issuing reference standards for strength, quality, and purity. 9,10 The United States Pharmacopeia (USP) released monographs defining these standards, with the drug name as the title of the monograph.
The AMA, the USP, and industry representatives gathered on July 22, 1960 at the USP Conference on Nonproprietary Names for Drugs to examine nonproprietary names for drugs as well as a proposal to consolidate nomenclature. There were concerns that the old system did not require each drug to have a nonproprietary name, that there was no central list of names, and that there was no legal necessity that all companies use the same name for a substance.
The USP named the program that subsequently became USAN a “cooperative program for the selection of non-proprietary names of pharmaceuticals” in a proposal to the AMA dated November 7, 1960. “The American Medical Association will maintain and expand, as necessary, its current facilities for receiving proposals of nonproprietary names from all sources, will process these proposals, and will initiate and conduct such negotiations as may be appropriate to settle upon a tentative name for all new drug entities,” according to the proposal’s draft. The USP promised to use the chosen names as USP monograph titles and to publish a list of them.
The founders opted not to involve the federal government on nomenclature in order to achieve industrial cooperation. “The industry appears to have no specific preference as to which agency operates as a clearing-house,” according to a July 15 memorandum provided to attendees by the USP’s Lloyd Miller just before the USP Conference on Non-Proprietary Names for Drugs. However, there is a desire to keep the name selection program independent from the FDA’s new medication application processing. The FDA hasn’t been particularly concerned with nonproprietary names in the past.”
The AMA-USP Nomenclature Program was founded in June 1961 as a result of these negotiations.
The American Pharmacists Association (APhA) joined the American Medical Association (AMA) and the United States Pharmacopeia (USP) in financing the committee’s nomenclature efforts in 1963. The partners decided that the council would consist of three representatives from each of the sponsoring organizations, as well as a member from the general public. The committee was renamed the USAN Council, and the names chosen were dubbed USAN. The USP agreed to use USAN as a monograph title, and the APhA consented to use USAN as a National Formulary title through its Committee on National Formulary. The agreement was changed again in 1967, and a representative from the Food and Drug Administration was added to the council. It was decided that AMA employees would keep track of all interactions made during the name selection and negotiation process. The USAN Council used to and still does operate independently of the FDA and is not an advisory group to the agency.
What USAN Names
Since the WHO, AMA, USP, and APhA began assigning names to pharmaceuticals, over 10 000 have been given nonproprietary names, which are listed in online databases such as the USP Dictionary of USAN and International Drug Names. 1 The USAN program identified 198 compounds in 2018. The number of USAN adoptions varies from year to year, but has consistently increased over the last two decades.
The anticipated therapeutic indication that the firm specifies when applying for a name on the statement of adoption is published by the USAN Program (see Table 2). In 2018, 71 compounds (36%) were identified as potential antineoplastics (ie, oncology drugs that attack tumors). Neurologic ailments such as Parkinson’s disease (22 compounds, or 11 percent), infectious diseases (18 substances, or 9 percent), and rare, genetic disorders such as Crigler-Najjar syndrome or Fabry disease are also common criteria for novel substances named (24 substances, or 12 percent ). For common illnesses affecting significant numbers of patients, such as diabetes, depression, or high blood pressure, relatively few medications (or none) were named.
It’s difficult to develop new therapies for common ailments for which there are current treatments. Pharmaceutical corporations are profit-driven businesses that aim to maximize profits while minimizing risks, and researching new pharmaceuticals is a high-risk endeavor. Although there has been some controversy about the exact cost of creating a drug, the most generally circulated contemporary estimate is that bringing a drug to market costs around $2.6 billion. 13 Despite the fact that failure rates differ by therapeutic class, the majority of medications that enter clinical trials fail. 14 As a result, discovering novel medications that target existing systems and are clinically meaningfully different from existing products might be difficult. 15 As a result, when there is less competition from low-cost medicines, pharmaceutical corporations may find it more financially viable to create pharmaceuticals.
It’s unclear whether pharmaceutical companies’ focus on oncology and rare diseases, rather than expensive biologic drugspossibly with less emphasis on developing affordable drugs for conditions that affect a large number of people (e.g., diabetes, high blood pressure)restricts access to adequate care. If existing low-cost prescription medications to treat common chronic illnesses are sufficient, new treatments, which are typically more expensive than previous meds, may not be required.
What Names Mean
The most essential factors in naming medications are avoiding drug names that are too similar to current namesthus jeopardizing patient safetyand ensuring that the drug name communicates correct information about the substance’s action or use. The USAN and INN nomenclature schemes have evolved into a mechanism for categorizing novel medications throughout time.
Many of the earliest medications were given names by abbreviating the compound’s systematic chemical name. The AMA-USP Nomenclature Committee rapidly realized that a new approach to naming pharmaceuticals was required, and established a set of guiding principles to standardize nomenclature and move away from names derived from a substance’s chemical name. 16 The AMA-USP Nomenclature Committee highlighted three issues with chemically generated names at the time: (1) the use of chemical syllables resulted in “complex, unmanageable” names for large classes of chemically related drugs; (2) common, chemically derived syllables (e.g., di-, chlor-, meth-) were becoming less distinctive; and (3) some chemical compounds were so complex that names derived from the proper chemical name were not meaningful to physicians.
As a result, most USAN now have a stem. A stem is made up of syllables that represent a chemical structure, indication, or activity at a specific receptor and is usually found at the end of a name. Imatinib’s -tinib stem, for example, relates to the drug’s function as a tyrosine kinase (TYK) inhibitor. A substem is occasionally used to further classify a medication. Thus, -citinib refers to medications that inhibit the Janus kinases, a subfamily of TYK inhibitors. There are currently around 600 stems and substems for drug classes that have been established. 17
Each medicine is distinguished from other members of the same class by a one- or two-syllable prefix at the start of its name. Patient safety is the most crucial consideration when selecting a prefix, specifically lowering the chance of drug errors, which are a significant and long-standing problem in medical practice. 18,19 As a result, the USAN Council discourages using prefixes that may result in new names that are too similar to other drugs in the same stem class or to names from other stem classes that may seem or sound similar to the new name. This entails matching drug names to lists of existing drug names. Prefixes are thoroughly screened by the USAN Program utilizing databases of current medication names1,11 and software called Phonetic and Orthographic Computer Analysis (POCA). 20 The USAN Program also avoids establishing new drug names that share letters with current generic or trade names for drugs or that have been identified to have strong conflicts with other names in the POCA analysis as much as feasible. A study of trade-name pairs that are prone to look-alike-sound-alike pharmaceutical errors discovered that they frequently had similar prefix strings of three or more letters and POCA scores that indicated a conflict. 21
Balancing the Needs of Firms and Patients
There will be conflicts, as there will be in any complex multiparty negotiation. The focus of the USAN Council on patient safety, access to new drugs, and communicating important information about drugs through the generic name sometimes clashes with pharmaceutical companies’ desires to convey a specific message about their drugs or a positive image for their substances through the generic name. While companies’ desires are understandable, the USAN Council places a higher priority on patient safety and affordable drug access.
The class to which a medicine is designated can have an indirect impact on a company’s decision to continue developing it. There are sometimes financial benefits to assigning a medicine to a specific drug class, while assigning a drug to an undesired drug class (often one with safety issues) can have a negative impact on drug development. Pharmaceutical companies produce more medications in classes that they believe are commercially feasible because they are in business to make money for their investors.
Payers and pharmacy benefit managers may be hesitant to put a “me-too” prescription in their formulary, but may accept an expensive drug if it is a first-in-class therapy because it is seen to provide added value that justifies a higher price. A first-in-class medicine may be more valuable to investors or larger, more established pharmaceutical companies wanting to acquire the rights to develop and commercialize new drugs for a tiny biotech company. As a result, companies may request the assignment of a new stem to show that a medicine is the first of its kind. Drugs that are first-in-class have a higher market share, but if the second or third member of a class improves on the first in a clinically significant way, it can be a successful product. 22,23,24
As a result, the USAN Council must consider how companies’ requests for a drug to be labeled a certain manner may affect access to pharmaceuticals and the cost of such medications. A new stem is only assigned when the council determines that a medicine is truly novel and does not belong in any of the existing groups. Unnecessary stem assignment could cause insurers and patients to pay more for treatments that are comparable to older, less expensive versions, impacting patients’ access to drugs indirectly. Similarly, if a company’s choice to stop a developmental drug is influenced by an unfavorable nomenclature decision, patient access may be harmed.
Conclusions
Because a substance cannot be marketed in the United States without a name, assigning a USAN has been a crucial step in the development and marketing of a new active pharmaceutical ingredient for decades. The USAN Council’s main goals are to make medicine usage safer by assigning names that are unlikely to cause medical errors and to guarantee that drug names represent what physicians, pharmacists, and patients need to know about each substance. The USAN has the ability to influence how payers, health-care professionals, patients, and the investing community see a drugand hence patients’ access to pharmaceuticals.
What is drug nomenclature, and what are the two methods for identifying drugs?
-Drugs have a variety of names, including chemical, generic, official, and trade names. -Chemical name identifies the chemical make-up of the medicine. -A generic name indicates a drug’s active ingredient and is the term given to it by the firm who created it initially.
Why are generic names given to drugs?
When pharmaceuticals are prescribed and prescriptions are dispensed, generic and brand names must be distinct to avoid one drug from being confused for another. To avoid any potential confusion, the FDA must approve each proposed brand name.
Why are medicine names so difficult to pronounce?
“What you see today that has been accepted is largely a reflection of the atmosphere in which we work.” That could explain why there are so many strangeor, to borrow Piergrossi’s termdrug brand names “Characteristics of a novel” Drug names, for example, utilize the letter Q three times more frequently than words in the English language.
What is the impact of the economy on the pharmaceutical industry?
First, the pharmaceutical business directly contributes to global GDP and employs a large number of people. Second, because of its reliance on worldwide supply networks, the global pharmaceutical sector supports further value creation and employment through its economic activity.
In a downturn, how does biotech fare?
During the three economic downturns, the biotechnology indexes lost 1% on average, compared to -10% for the pharmaceutical index and -20% for the S&P 500 index. “In terms of relative performance, the biotech and pharmaceutical indices outpaced the S&P 500 by 18% and 10%, respectively,” Porges said.
Is medical sales immune to the downturn?
A position in the medical industry, whether you’re a doctor, physician assistant, nurse, or radiographer, is an excellent location to work during a recession.
What is going on in the economy has no bearing on our physical or emotional wellness. Even in a downturn, people will become unwell. Appendixes will break, babies will be born, and accidents will occur.
If you want the most employment stability, a career at a hospital or clinic is a good option. People will get sick and injured, regardless of what happens in the stock market or with GDP growth. They will require medical attention. Many recession-proof occupations are available in the healthcare business.
When a medicine is granted its official name, what kind of name is given?
There are three names for a marketed drug: a chemical name, a generic name, and a brand name. When a new chemical entity (NCE) is created, it is given a chemical name. The chemical name is a scientific name based on the chemical structure of the compound (e.g., 6-thioguanine) and is almost never used in clinical or marketing situations to identify the medicine. The USAN Council grants the generic name, which is usually used to identify a medicine during its useful clinical life. The brand name is created by the company that owns the patent on the drug (trademark). During the 17 years that the corporation has exclusive rights to create, market, and use the drug under patent law, this name is used to identify it.