In my last article, I discussed International Non-proprietary Names (INNs) and their importance for drug nomenclature in the pharmaceutical industry. Here I continue that thread discussing the United States Adopted Names (USAN) system. USAN, like INN, assumes a central role in ensuring clarity, consistency, and precision in the identification of drugs. The USAN name, a nonproprietary designation, serves as a linchpin for effective communication among healthcare professionals, researchers, regulatory bodies, and patients. In this article, I go into further details on the essence of USAN names and outline the process of securing approval for these critical drug identifiers.
The Essence of USAN Names:
The USAN system, managed by the United States Pharmacopeia (USP) in collaboration with the American Medical Association (AMA) and the Food and Drug Administration (FDA), aims to bestow each active substance with a unique, standardized, and scientifically sound name. Unlike proprietary or brand names, which are exclusive to specific manufacturers and often carry commercial connotations, USAN names are neutral, generic, and universally accepted. They play an essential role in ensuring clarity in drug identification, communication, and pharmacovigilance on a national and international scale.
The Significance of USAN Names:
Precision and Scientific Identity: USAN names are meticulously crafted to reflect the scientific characteristics of the drug, encompassing its pharmacological class, mechanism of action, and therapeutic application. This aids healthcare professionals in comprehending a drug's attributes at a glance.
Interchangeability and Generics: In the realm of generic drugs, USAN names are indispensable. Generic drug manufacturers utilize the USAN name to create bioequivalent versions of brand-name drugs. This facilitates the substitution of brand-name medications with generic equivalents, ensuring accessibility and affordability while maintaining therapeutic efficacy.
Pharmacovigilance and Patient Safety: The distinct and standardized nature of USAN names contributes to efficient pharmacovigilance efforts. Medical professionals and regulatory agencies can swiftly recognize drugs by their USAN names, streamlining the reporting and investigation of potential adverse effects.
Global Compatibility: The uniformity of USAN names transcends linguistic and cultural disparities, promoting seamless communication in an increasingly interconnected global healthcare ecosystem.
BUT WAIT, you say, Isn't that just an INN?
USAN names and INN names are both nonproprietary names for drugs. They are assigned by different organizations, but they have similar goals.
- USAN names are assigned by the United States Adopted Names Council (USAN Council). As noted above, the USAN Council is a collaboration between the American Medical Association (AMA), the United States Pharmacopeial Convention (USP), the FDA, and the American Pharmacists Association (APhA).
- INN names are assigned by the World Health Organization (WHO). The WHO is an international organization that sets standards for health care.
Both USAN names and INN names are intended to be:
- Unique: Each name should be used for only one drug.
- Easy to pronounce (ahem...so they say...'cough') and remember: The names should be easy for patients and healthcare professionals to use (uh-huh).
- Neutral: The names should not be offensive or misleading.
In general, USAN names and INN names are the same. However, there are a few exceptions. For example, some drugs have different USAN names and INN names in the United States and in other countries. Additionally, some drugs have different USAN names and INN names for different dosage forms.
Here is a table that summarizes the similarities and differences between USAN names and INN names:
Securing Approval for a USAN Name:
The journey to securing a USAN name is a systematic guided process:
Substantial New Investigational Compound: To qualify for a USAN name, a compound must possess attributes of novelty, scientific merit, and potential therapeutic value. This ensures that only compounds with substantial contributions to medical science are considered.
Sponsorship: Drug manufacturers or developers, referred to as "sponsors," submit requests for USAN names to the USAN Council. The sponsorship showcases the scientific and clinical relevance of the compound.
Scientific Evaluation: The USAN Council comprises experts from various medical disciplines. This council rigorously evaluates the submitted information to ascertain the compound's scientific attributes and its compatibility with existing nomenclature.
Naming Process: The USAN Council formulates a name by adhering to specific naming conventions. This typically involves selecting a stem—indicative of the compound's pharmacological class—and combining it with a prefix or suffix to create a distinct and accurate name.
Avoiding Confusion: The USAN Council diligently avoids names that could lead to confusion with existing proprietary names, trademarks, or established nomenclature.
Balancing Uniformity and Specificity: The USAN name strikes a balance between being specific enough to convey relevant information and being general enough to encompass potential future variations or analogs of the compound.
Approval and Announcement: Once the USAN name is approved, it is officially announced, and the name becomes part of the global pharmaceutical lexicon.
In summary, the United States Adopted Names (USAN) system bestows drugs with standardized, nonproprietary designations, very similar to the INN system. The USAN system enhances communication, fosters scientific integrity, and bolsters patient safety. The process of obtaining approval for a USAN name embodies rigorous evaluation, scientific merit, and dedication to ensuring a uniform and coherent drug nomenclature.
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