Common name used to describe the clinical/medical domain or messaging standard requirement that has been examined.

Allergy Information

Describe the specific purpose/primary use of this standard in the federal health care sector (100 words or less)

The standards, as identified in the following section of this document, will be used to set the requirements for exchanging allergy data, across the federal health community to provide the federal health community with a key component needed to enable federal agencies to build interoperable health data systems health vocabulary.

It is anticipated that use of these standards will enable the federal health enterprise to exchange allergy health information across the wide range of federal activities helping to decrease medication errors, identify food and drug incompatibilities and provide consistent allergy data across the federal health community.

Domain/Sub-domain

In-Scope (Y/N)

Allergy

Y

Adverse Reactions

N

Care Management Information

Case Management Information

Clinical Guidelines

Customer Demographic Data

Customer Healthcare Data

Customer Risk Factors

Population Member Health Data

Population Risk Reduction Plan

Tailored Education Information

Name

Agency/Department

Marcia Insley (Colead)

Department of Veterans Affairs, Veterans Health Administration

Lenora Barnes (Colead)

Department of Veterans Affairs, Veterans Health Administration

Siew Lam

Department of Veterans Affairs, Veterans Health Administration

Pradnya Warnekar

Department of Veterans Affairs, Veterans Health Administration

Mike J. Lincoln

Department of Veterans Affairs, Veterans Health Administration

Roger Sigley

Department of Veterans Affairs, Veterans Health Administration

Randy Levin

Department of Health and Human Services, Food and Drug Administration

William A. Hess

Department of Health and Human Services, Food and Drug Administration

Elizabeth C. Smith

Department of Health and Human Services, Food and Drug Administration

Stefano Luccioli

Department of Health and Human Services, Food and Drug Administration

William Pierce

Department of Health and Human Services, Food and Drug Administration

Cheryl Ford

Department of Health and Human Services, Centers for Medicare and Medicaid

Don Reese

Department of Health and Human Services, Centers for Medicare and Medicaid

Fola Parrish

Department of Defense, OASD(HA)/TRICARE Management Activity

Nancy Orvis

Department of Defense, OASD(HA)/TRICARE Management Activity

Mark Charles

Department of Defense, OASD(HA)/TRICARE Management Activity

Ronald Nosek

Department of Defense, OASD(HA)/TRICARE Management Activity

Mathew Garber

Department of Defense, OASD(HA)/TRICARE Management Activity

Michael Datena

Department of Defense, OASD(HA)/TRICARE Management  Activity

John Kilbourne

Department of Health and Human Services, National Library of Medicine

John Harman

Environmental  Protection Agency

Start

End

May 27, 2005

April 30, 2006

Health Level Seven^® (HL7^®), Version 2.4 and higher: Information Exchange Segment

UNII: Allergen Code, Mnemonic, Description

RxNorm, Drug Brand Name (BN): Allergen Code, Mnemonic, Description

NDF-RT™: Allergen Group, Drug Classes (Chemical Structure)

SNOMED CT^®: Allergy Type, Allergy Severity, Allergy Reaction

HL7^®
Headquartered in Ann Arbor, MI, Health Level Seven^® (HL7^®) is a not-for-profit volunteer organization. Its members-- providers, vendors, payers, consultants, government groups and others who have an interest in the development and advancement of clinical and administrative standards for healthcare—develop the standards. Like all ANSI-accredited Standards Development Organizations (SDOs), HL7^® adheres to a strict and well-defined set of operating procedures that ensures consensus, openness and balance of interest.  HL7^® develops specifications; the most widely used being a messaging standard that enables disparate healthcare applications to exchange key sets of clinical and administrative data.  Members of HL7^® are known collectively as the Working Group, which is organized into technical committees and special interest groups. The technical committees are directly responsible for the content of the standards. Special interest groups serve as a test bed for exploring new areas that may need coverage in HL7^®’s published standards.

UNII
Food and Drug Administration Substance Registration System  (FDA SRS)
The FDA SRS generates unique, unambiguous authoritative identifiers for substances in FDA regulated products such as ingredients in drug products.  These non-proprietary Unique Ingredient Identifiers (UNII) are designed to be free for use in health information technology systems worldwide and are one of the core components of the Federal medication terminology.  In addition, AHRQ supports, both conceptually and financially, the development of the UNII to improve patient safety and quality of care.

The UNII is linked to drug products as part of the FDA's Structured Product Labeling (SPL). SPL (including the UNII) will be made available in the DailyMed^®, a web-based distribution of the SPL maintained by NLM.  In addition, FDA UNII codes will be linked to RxNorm clinical drug codes. This will allow the brand name clinical drug to be captured and reported via a UNII code.  The UNII was adopted in May 2004 by the Consolidated Health Informatics initiative as a part of its Medication Domain after being recommended to the DHHS Secretary by the National Committee on Vital and Health Statistics.

The FDA SRS uses chemical structure, names, and descriptions to generate the UNII.  The primary means for defining a substance is by its molecular structure represented on a two-dimensional plane.  When a molecular structure is not available, the UNII is defined by a distinct name, and where necessary, an identifying description. Substances are registered in the FDA SRS following detailed business rules for processing the information. The standard is maintained by the FDA Data Standards Council and is monitored by the FDA SRS Board consisting of experts from the FDA and USP. 

The FDA SRS includes substances used in, or intended to be used in drugs, biologics, devices, cosmetics and foods.

Drug-related substances include both active and inactive ingredients used in drug products, including those for veterinary purposes.  FDA is aggressively working on dramatically increasing the number of UNII codes, through a Cooperative Research and Development Agreement (CRADA) with the United States Pharmacopeia.  FDA’s goal is to load all 8,000 drug-related substances that currently appear in the USP Dictionary of USAN and International Drug Names by September 2006.  The FDA has (1) UNII codes available for 100% of the active ingredients that are in approved and currently marketed prescription human drugs, and these UNII codes are now being incorporated into Structured Product Labeling (SPL), (2) a total of approximately 6,000 drug-related substances in the FDA SRS, and of these, approximately 3,000 have UNIIs, (3) publicly released 972 UNII codes in March 2005, which at that point in time represented approximately 80% of the active ingredients that were in approved and marketed prescription drug products, and (4) these 972 UNII codes that were released in March 2005 have appeared in the National Cancer Institute’s publicly accessible Terminology Browser at http://nciterms.nci.nih.gov/NCIBrowser/Dictionary.do  since August 2005; they have been, and currently are, accessible through both an on-line web-based query and through a public API.  

Biologic substances include both active and inactive ingredients used in biologics, such as blood products, therapeutic products, vaccines, cellular and gene therapy products, allergenic products, tissues, and certain devices (e.g., enzymes in stabilized solutions).  Although not technically always regulated by FDA as a biologic substance, botanical substances (also sometimes known as ‘herbals’) will be available in the FDA SRS.

Device substances include certain components of some devices (e.g. silicon for implants, and chemical reagents for glucose test kits). Cosmetic substances are components of cosmetic products, such as flavors, fragrances, colorants, vitamins, plant- and animal-derived ingredients, and polymers.

Since allergenic extracts are regulated by FDA, they will be included in the FDA SRS.  Similarly, since there are many drugs, biologics, foods, and device components that can result in an allergic response, and since the FDA regulates these substances, they will be included in the FDA SRS.  Therefore, since there are so many substances that can cause an allergic response already in the FDA SRS, it makes sense to expand the scope of the FDA SRS to include other substances that are capable of an allergic response.

Food substances are specific foods or components of food, regardless of whether the food is in conventional food form or a dietary supplement, such as vitamins, minerals, herbs, or other similar nutritional substances. While the SRS will not serve as a classification system, the description of a substance may sometimes be at a high enough level where classification is readily understood.  An example of this is the FALCPA (Food Allergen Labeling and Consumer Protection Act) which identifies eight (8) major food allergen categories that will be entered in the FDA SRS.  

FDA plans to import substances into the FDA SRS from several sources, including but not limited to, the European Agency for the Evaluation of Medicinal Products (EMEA), Environmental Protection Agency Substance Registry System (EPA SRS), Food Allergen Labeling and Consumer Protection Act  (FALCPA), International Nonproprietary Names (INN,) LanguaL (Language of  Foods), VA Non Drug Allergen List, National Cancer Institute (NCI),  National Library of Medicine (NLM), Therapeutic Goods Administration, Australia (TGA), United States Adopted Names (USAN), and United States Pharmacopeia (USP).

Environment Protection Agency Substance Registry System (EPA SRS)
The EPA and the FDA have agreed to create direct linkages between the EPA SRS and the FDA SRS so that users of either system will have access to the data in both.  The EPA SRS will store the UNII for those substances that are common between the two systems; the FDA SRS will store the EPA SRS Internal Tracking Number, which is a unique number assigned to each substance for computer to computer communication.  The EPA SRS is currently the adopted Consolidated Health Informatics (CHI) recommended standard for non drug chemicals terminology.

The EPA SRS is that agency’s authoritative resource for basic information about chemicals, biological organisms and other substances of interest to the Environmental Protection Agency (EPA) and its state and tribal partners.  It relies on standardized fields to ensure that each substance is uniquely identified across all of the Agency’s programs.  As chemicals and biological organisms a primary focus of the EPA, it is fundamental that they are properly cataloged and identified.

EPA created the EPA SRS to provide a central place for identifying substances that are tracked or regulated at the Agency and to catalog basic information about them.  It contains records for more than 95,000 chemicals, biological organisms, viruses and other substances.  The significant work required to maintain the currency of the data, including the CAS names and numbers, benefits the CHI work.

Each record contains standardized agency identifiers, as required by two data standards developed between EPA and its state and tribal partners.  States and tribes now are adopting these identifiers internally.  For chemicals, these standardized identifiers include the Chemical Abstracts Service (CAS) Number, the molecular weight, and the EPA preferred name.  For biological organisms, standardized identifiers include the Taxonomic Serial Number (TSN) and the taxonomic name.  In addition, each record includes synonyms used in the Agency and identifies the statutes, regulations and databases that use those synonyms.  Importantly for the CHI work, there are links to health and safety data developed internally at EPA or externally by states, other federal agencies, or international organizations. 

Although there can be many synonyms for the same substance, SRS makes it possible to determine which EPA program is tracking or regulating a substance and the name used by that program.  SRS therefore is a one-stop resource that enables EPA staff, states, tribes, industry, and the public to discover where to find Agency data about a substance.

RxNorm
RxNorm is a public domain terminology developed by the NLM in conjunction with the VA and the FDA, in consultation with HL7 and supported by AHRQ

The lack of interoperability among the terminologies used in the proprietary pharmaceutical knowledge bases was the primary motivation for RxNorm’s development. A user wishing to use one pharmaceutical knowledge base system for pricing and inventory control, for example, and a different system for interaction checking finds it difficult to merge the two systems into a larger environment.  This issue was discussed at HL7 meetings for several years, with representatives from each of the pharmaceutical knowledge base providers as active participants. It became apparent that interoperability at the clinical drug level might be an achievable goal, if a standard clinical drug nomenclature was developed and the terminologies in the various proprietary systems were mapped to it.  

The NLM initiated the development of the public domain RxNorm vocabulary to achieve this goal – and simultaneously to eliminate the problem of undetected synonymy among proprietary clinical drug names within the UMLS^® Metathesaurus.  RxNorm has a robust information model that also supports ordering of medications.   The VA, the FDA, the NCI, and the DOD are building use of RxNorm into their system development plans.  The NLM continues to add new clinical drugs and links to additional drug terminologies and to refine the model in response to feedback.  RxNorm is currently released on a monthly basis, and the May 2006 release had 31432 current clinical drugs. RxNorm links to more complete information in the VA NDF-RT™, such as drug classes, as well as to other terminologies available from commercial drug database vendors in the USA. RxNorm is being continuously developed and upgraded in conjunction with these various sources as well as with the FDA SPL data, and so represents the best potential for a comprehensive superset of all available drugs and an interlingua between various commercial and governmental drug sources.

NDF-RT™: Drug Classification (Chemical Structure)

The National Drug File Reference Terminology (NDF-RT™) classification scheme has already been endorsed as a CHI Adopted standard for Physiological Effect and Mechanism of Action. NDF-RT™ chemical structure classification is being recommended under the allergy domain for chemical structure classification. NDF-RT™ contains the chemical structures, and makes links to drug ingredients, but the chemical structure concepts come MeSH^® stored in the UMLS^®. This classification scheme will assist in identifying a class of drug that a patient may be allergic to even if a specific drug is not known. If a specific drug is known, a chemical classification standard may assist in identifying a wider potential group of drug allergens.

In addition, the FDA UNII codes are being included in NDF-RT™ as properties of the various drug ingredients. As part of the FDA Structured Product Label (SPL) initiative, UNII codes will be transmitted to NLM’s DailyMed^®  as part of the SPL and will then be loaded into NDF-RT™ through the “New Drug Transaction”.  Thus the percentage of ingredients with UNII will rise progressively.

SNOMED^®

The College of American Pathologists (CAP) is holder of the copyright, trademark and patent rights in SNOMED^®.  The CAP owns the copyright in all editions of SNOMED^®, including the copyright in any allowable adaptations, the trademarks SNOMED^® and SNOMED CT^®, and any and all patent rights in SNOMED^®.  Within the governance structure of the CAP, the SNOMED^® International Authority has the direct responsibility for terminology-related activities. It establishes strategic direction for the CAP’s clinical terminology activities, advises management, monitors division performance, and provides connections to the broader outside world. The SNOMED^® International Authority protects the purpose of SNOMED^® for clinical care and prevents drift of its purpose through its constitution, decision-making criteria, and the expertise of voting members.

The SNOMED^® International Editorial Board is responsible for the scientific direction, editorial processes, and scientific validity of the terminology. The Editorial Board, composed of voting members and organizational liaisons, recommends guidelines for external input and field-testing. It also oversees the quality assurance process.  The Editorial Board consists of both clinical content experts and medical informatics experts, with equal representation from the UK’s National Health Service. In addition, liaisons from numerous associations reflect the vision of an integrated clinical vocabulary useful for dentistry, nursing, veterinary medicine, radiology, ophthalmology, public health, and other clinical specialties, and that is compatible with standards such as HL7^® and DICOM^®. Participation of liaisons ensures scientific input from a range of clinical specialties and government agencies. Chaired by the SNOMED^® Scientific Director, this group provides scientific direction for and supports the work of a multidisciplinary team of modelers and data administrators. 

The approach of this workgroup was as follows:

• Identified previously approved CHI standards applicable to the allergy domain
• Performed comprehensive review of standards and early elimination of any that did not properly meet the immediate allergy requirements for the data elements or concepts identified as allergy related
• Developed checklist of data elements needed for proper allergy descriptions, classifications, types, reactions and severities
• SMEs performed a comparison of each candidate standard
• Selected the standard that best met the overall allergy terminology requirements identified, along with noting obstacles and recommendations for filling any gaps

Allergy Domain

Recommendation

Status

Information Exchange Segment

HL7^® 2.x and above

Allergen Name, Mnemonic, Description for  Brand Name Drugs

RxNorm BN

Allergen Name, Mnemonic, Description,

UNII code from the FDA SRS / EPA SRS

Conditional as noted below and components summarized on Allergy Schematic

Allergen Group, Drug Classes (Chemical structure)

NDF-RT™

Conditional as noted below

Allergy Type, Allergy Severity and Allergy Reaction

SNOMED CT^®

With recommendation for SNOMED^®/HL7^® collaboration and SNOMED CT^® allergy subset consideration

The Work Group recommends the adoption of the proposed allergy standards. For implementation purposes, the following conditions must be met:

• At least 90% of the UNII codes for active ingredients for approved and marketed prescription drugs have been completed by the FDA
• UNII codes are made publicly available through a simple download mechanism
• Updates to UNII codes are made publicly available on at least a quarterly basis.
• The plan for UNII code development and maintenance beyond active ingredients for approved and marketed prescription drugs is documented.
• The updated version of the NDF-RT™, 2006 or later, is made publicly available through a simple download mechanism.

The workgroup identified gaps and areas of needed improvement in the standard that would improve utility, these can be found in the “Gaps” section, Part III.

Approvals
&
Accreditations

Yes/Approved

Applied

Not Approved

Full SDO Ballot

Y

ANSI

Y

Allergy Information Exchange/Models/Initiatives:

HL7^®
SNOMED^®
CHDR
FAET
NCPDP
NEHTA

Terminologies:

Allergen Type:
HL7^®
SNOMED CT^®

Allergy Severity:
HL7^®
SNOMED CT^®

Allergy Reaction:
VA/DOD List
SNOMED CT^®

Allergen Code/Mnemonic/Description:

Drug:  
UNII Codes
RxNorm
SNOMED CT^®
SPL
NDC
USP-NF
INN
IUPAC
CAS

Food:
LanguaL
Food Product Code
Codex Alimentarius^®
EAFUS
USDA List
Allergome
IUIS
VA Non Drug Allergen Lists
FDA SRS
EPA SRS

Environmental:
EPA SRS
FDA SRS
VA Non Drug Allergen Lists

Non Drug/Other:
EPA SRS
FDA SRS
VA Non Drug Allergen Lists

Class of Allergen

Drug Classification:
NDF-RT™
SPL
SNOMED CT^®
NDC
ATC
AHFS
USP
FDB
MeSH
Multum
Micromedex
Medispan

Food Classification:
FALCPA- Food Allergen Labeling and Consumer Protection Act

Summarize the degree of market penetration today; i.e., where is this solution installed today?

HL7^® is used in many places as the messaging standard for health care data.  Furthermore, HL7^® has a great deal of support in the user community and 1999 membership records indicate over 1,600 total members, approximately 739 vendors, 652 healthcare providers, 104 consultants, and 111 general interest/payer agencies. HL7^® standards are also widely implemented, though complete usage statistics are not available. In a survey of 153 chief information officers in 1998, 80% used HL7^® within their institutions, and 13.5% were planning to implement HL7^® in the future. In hospitals with over 400 beds, more than 95% use HL7^®. As an example, one vendor has installed 856 HL7^® standard interfaces as of mid 1996.  It is the proposed message standard for the Claims Attachment transaction of the Administration Simplification section of the Health Insurance Portability and Accountability Act (HIPAA). Anecdotal information indicates that the major vendors of medical software, including Cerner, Misys (Sunquest), McKesson, Siemens (SMS), Eclipsys, AGFA, Logicare, MRS, Tamtron, IDX (Extend and CareCast), and 3M, support HL7^®. The most common use of HL7^® is probably admission/discharge/transfer (ADT) interfaces, followed closely by laboratory results, orders, and then pharmacy. HL7^® is also used by many federal agencies including VHA, DoD and CDC, hence federal implementation time and cost is minimized. The widespread and long-standing use of HL7^® leads to the team conclusion that this is a strong recommendation.

What number or percentage of federal agencies have adopted the standard?

Many federal agencies, several of which are represented within the CHI group, have adopted HL7 for messaging.

Is the standard used in other countries?

Yes, Argentina, Australia, Canada, China, Czech Republic, Finland, Germany, India, Japan, Korea, Lithuania, The Netherlands, New Zealand, Southern Africa, Switzerland, Taiwan, Turkey and the United Kingdom are also part of HL7^® initiatives.

Are there other relevant indicators of market acceptance?

Yes, this standard is so widely accepted and used across the healthcare industry; see the market penetration section for vendor and federal agency use.

Summarize the degree of market penetration today; i.e., where is this solution installed today?

On July 1, 2003, an agreement with the College of American Pathologists (CAP) and HHS was announced that made SNOMED Clinical Terms (SNOMED CT^®) available to U.S. users at no cost through the National Library of Medicine's^® Unified Medical Language System^® (UMLS^®).

Produced by the College of American Pathologists (CAP), SNOMED CT^®  (Systematized Nomenclature of Medicine--Clinical Terms) was formed by the convergence of SNOMED RT^® and the United Kingdom's Clinical Terms Version 3 (formerly known as the Read Codes). With terms for more than 344,000 concepts, SNOMED CT^®  is the most comprehensive clinical terminology available. It is being implemented throughout the National Health Service in the United Kingdom.

The National Library of Medicine (NLM), a component of the National Institutes of Health (NIH), Department of Health and Human Services, has issued a 5-year, $32.4 million contract to the CAP for a perpetual license for the core SNOMED CT^®  (in Spanish and English) and ongoing updates. NLM is paying the annual update fees. Funding for the one-time payment for the perpetual license was provided by:
Department of Health and Human Services
National Institutes of Health (Office of the NIH Director & NLM
Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry
Office of the HHS Assistant Secretary for Planning and Evaluation
Agency for Healthcare Research and Quality
Centers for Medicare & Medicaid Services
Food and Drug Administration
Indian Health Service
Substance Abuse and Mental Health Services Administration
Health Resources and Services Administration
Department of Defense
Department of Veterans Affairs

NLM distributes SNOMED CT^®within the UMLS^®  Metathesaurus under the terms of a revised UMLS^®  license agreement, which includes additional language concerning SNOMED CT^® . U.S. licensees will be able to use SNOMED^® (as distributed by NLM) in the U.S. without charge and without signing a separate license agreement with the CAP. Non-U.S. UMLS^® users will continue to require a separate license agreement with the CAP for production uses of SNOMED CT^®. Current UMLS^® users will have to sign the revised license agreement before receiving SNOMED CT^® within the UMLS^®. With the release of the 2004AA version of the UMLS^®, the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT^®), produced by the CAP, becomes available for free U.S. use under a license agreement concluded last year. Users must register via the Web for a free UMLS^® license before downloading the Metathesaurus or requesting a copy on DVD.

What number or percentage of relevant vendors has adopted the standard?

The state of incorporation into vendor systems varies and is largely dependent on the vendor’s development cycle. Following is a representative list of the vendors who have licensed SNOMED CT^®, it should be noted that license does not equate to adoption.

What number or percentage of healthcare institutions has adopted the standard?

More than 50 commercial healthcare software developers have incorporated SNOMED CT^® into their systems. 

Two examples of the extent of support for SNOMED CT^® are Kaiser Permanente and the National Health Service (NHS) of the United Kingdom. Kaiser Permanente, who provides health care coverage to 3% of the U.S. population, has actively participated in the development of SNOMED CT^® and is actively rolling out SNOMED CT^®-compatible solutions throughout its organization. Kaiser is using SNOMED CT^® within domain-specific standard documentation templates for use throughout the organization.  Also, as of April 1, 2003, the NHS, representing a population of 56 million covered lives, officially stated that: “Subject to successful development and testing of implementability, after April 1, 2003 any computerized information system being developed to support any clinical information system, such as EPRs and EHRs, should use the NHS preferred clinical terminology, SNOMED^® Clinical Terms.” 

Other examples of health care institutions that have adopted SNOMED CT^® are summarized as follows: The University of Nebraska Medical Center is using SNOMED CT^® in the development of problem lists which are then mapped to ICD-9; Cedars Sinai Medical Center used SNOMED CT^® in its web-based order entry system which processed 700,000 orders for over 8,000 patients between October 2002 and January 2003;  HCA is implementing SNOMED CT^® within its laboratory network, consisting of over 200 sites in both the US and Canada, for lab test results and diagnosis;  University of Tennessee used SNOMED CT^® in the lab to improve patient safety by detecting cases for which follow-up intervention did not occur despite abnormal Pap tests;  Barnes Jewish Christian Health Care is using SNOMED CT^® within its perioperative and surgery suites for medical transcription.

What number or percentage of federal agencies have adopted the standard?

Versions of SNOMED CT^® are currently used by: the Centers for Disease Control and Prevention (CDC), Department of Defense (DoD), Indian Health Services (IHS) and the Department of Veterans Affairs (VA) in specific applications.  As SNOMED CT^® was first released in January, 2002, most of the government applications for which SNOMED CT^® has been licensed are in evaluation or developmental stages.

Is the standard used in other countries?

As of April, 2003, the CAP has licensed users of SNOMED CT^® in 31 countries. Earlier editions of SNOMED^® have been licensed in over 40 countries.  Following are the countries in which SNOMED CT^® has been licensed:

As previously noted, the UK’s National Health Service has officially stated that any computerized information system being developed to support any clinical information system, should use the NHS preferred clinical terminology, SNOMED^® Clinical Terms.

In Australia, where the use of electronic health cares systems to support general practice is relatively advanced, a “Coding Jury” had been established to select a single coding system to support GP clinical systems.  Currently, the GP Vocabulary Project is underway, and is designed to assist in the building and support of a standard general practice interface terminology suitable for the management of information collected during the clinical encounter. Phase 2 of this project will include the mapping of a subset of the GP Vocabulary to SNOMED CT^®.

Are there other relevant indicators of market acceptance?

Market share information provided by CAP indicates that 79% of computerized patient record systems and 85% of laboratory systems vendors have made licensing commitment.  Following are other relevant indicators of SNOMED’s^® market acceptance: 

• Both HL7^® and DICOM^® have formally recognized SNOMED^® as a standard code set within their messaging standard. SNOMED^® is embedded in the DICOM^® Structured Reporting Standard for Wave Forms.
• The American Veterinary Medical Association (AVMA) has adopted SNOMED CT^® as the official terminology for veterinary practice in the US. It has been used extensively by the veterinary community in a collaborative product to track health care data on a national basis.
• The American Nurses Association (ANA) has recognized SNOMED CT^® as a terminology that supports nursing practice, specifically: nursing assessments, plans, interventions and outcomes.
• WASPalm, the World Association of Societies of Pathology and Laboratory Medicine, representing 59 member societies throughout the world, has endorsed SNOMED^® as the preferred reference language for laboratory clinicians.

UNII is distributed by FDA and EPA without restriction.

Summarize the degree of market penetration today; i.e., where is this solution installed today?

UNII is part of the CHI medication domain for active ingredient.  As such, it is incorporated into FDA’s Structured Product Labeling (SPL) initiative, which will soon be used worldwide.  In addition, FDA SRS has already made its substance names and their Unique Ingredient Identifier (UNIIs) available to the following:  Department of Veterans Affairs (NDF-RT™), the National Library of Medicine^® (UMLS^®), the National Cancer Institute (NCI EVS), Environmental Protection Agency (EPA SRS) and the United States Pharmacopeia (USP Dictionary of USAN and International Drug Names).  Finally, each of these organizations, as well as the European Medicines Agency and Australian Therapeutics Goods Administration, has expressed a high degree of interest in loading their substance data into the FDA SRS. 

Currently, available UNIIs are accessible for public access and download through the NCI Terminology Browser/NCI_Thesaurus

(see  http://nciterms.nci.nih.gov/NCIBrowser/Dictionary.do).  

UNIIs will also be available as part of the new labeling format will be integrated into FDA's other e-Health efforts through a variety of ongoing initiatives. As prescription information is updated in this new format it will be used to provide medication information for DailyMed^®  – an interagency online health information clearinghouse, sponsored by the National Library of Medicine, which is maintaining the most up-to-date medication information free to consumers, healthcare professionals, and healthcare information providers. The DailyMed^® is making up-to-date information about FDA-regulated products widely available on the Internet at no cost. (http://dailymed.nlm.nih.gov)

 FDA has scheduled a second release of UNIIs by the end of July 2006, and that the dataset will include 100% of the active ingredients of approved and marketed prescription drug products, as well as many inactive ingredients; it may also include the initial portion of the USP work, as well as color additives, 760 botanical substances, vaccine substances, and allergenic food substances.

As noted, UNIIs for all active ingredients and many inactive ingredients are being integrated into SPL, and SPL is being made available through DailyMed^® at NLM.  Therefore, UNIIs are available by accessing DailyMed^®.  Presently, there are only a few SPL submissions in DailyMed^®, but that number is expected to exponentially increase due to a federal regulation that went into affect in October 2005.  The regulation requires that for approved and marketed prescription drugs, (1) all labeling that is included in annual reports shall be submitted in SPL, and (2) all labeling for newly approved drugs shall be submitted in SPL.  This means that by December 2006, all approved and marketed prescription drugs shall have SPL available (with UNIIs) through DailyMed^®.

What number of or percentage of relevant vendors have adopted the standard?

100% of pharmaceutical companies marketing prescription drug products in the United States and Structured Product Labeling vendors must use the UNII standard.  Most likely, a large percentage of healthcare decision support software vendors will seriously consider, if not overtly adopt, the UNIIs that enable healthcare decision support will already be embedded in SPL.

What number or percentage of healthcare institutions have adopted the standard?

None to date, but that is expected to rapidly change.

What number or percentage of federal agencies have adopted the standard?

100% of federal agencies have adopted the UNII as their standard for active ingredient through the White House’s Consolidated Health Informatics initiative.  Many federal agencies are in the process of implementing the UNII as their standard for active ingredient.  Since the UNII plans to also include inactive ingredients, it will soon have much greater utility, and federal agencies have begun to recognize that eventuality.

Is the standard used in other countries?

None to date, but that is expected to rapidly change.  The EMEA, Japan, Health Canada, and TGA are interested in adopting the UNII as their standard, and since the USP will be associating a UNII with each INN, and this adoption would make sense for these and other foreign drug regulatory bodies.

Are there other relevant indicators of market acceptance?

There are no additional relevant indicators of market acceptance.

The need to recommend RxNorm in addition to UNII codes stems from potential situations where data (historical data) may not be coded to the ingredient level. This is identified as a data need within DOD, where allergy information is captured at Brand Name and RxNorm (BN) can be assigned and exchanged.

RxNorm is distributed by without restriction.

Summarize the degree of market penetration today; i.e., where is this solution installed today?

RxNorm is distributed by the NLM without restriction. A listing of current users is not kept.

What number of or percentage of relevant vendors have adopted the standard?

RxNorm is distributed by the NLM without restriction. A listing of current users who are vendors is not kept.

What number or percentage of healthcare institutions have adopted the standard?

RxNorm is distributed by the NLM without restriction. A listing of current users who are healthcare institutions is not kept.

What number or percentage of federal agencies have adopted the standard?

RxNorm is distributed via  by the NLM without restriction. A listing of current users who are federal agencies is not kept.

Is the standard used in other countries?

RxNorm is distributed via by the NLM without restriction. A listing of current users in other countries is not kept.

Are there other relevant indicators of market acceptance?

There are no additional relevant indicators of market acceptance.

Drug classification schemes developed to date meet specific decision support needs that vary across institutions. Content requirements placed on legacy systems and their supporting knowledge bases differ vastly depending on the use cases that the organization has to support. As a result there are structural classes where drugs are grouped together based on their chemistry or there are functional classes where drugs are grouped together based on their mechanism of action or therapeutic intent or physiologic effect.

In the allergy domain, there are two reasons why drugs would need to be grouped. First, to prevent ordering of drugs similar to the ones that the patient is allergic to, and second to simplify patient allergy documentation when it is difficult for a patient to recall the specific drug that (s)he is allergic to. Allergy to any drug is due to the presence of a specific chemical entity in the drug. For example, if a patient is allergic to a sulfonamide containing antimicrobials, then it is very likely that (s)he is also allergic to one of the  thiazide diuretics that are used to lower blood pressure. This illustrates that even though the two drugs have completely different therapeutic uses, they are likely to cause the same allergic reaction in the patient. This is because of similarity in chemical structures between the two classes of drugs. Thus, grouping drugs based on chemistry for patient allergy documentation is critical.

NDF-RT^TM is a reference terminology for medications developed by the VHA. It is based on the VHA’s current production system called VA NDF, but is intended to help separate the specific legacy use cases in VA for drug interactions and checking from the definitional classifications of drug ingredients. As a result, NDF-RT™ supports VA legacy codes (beta lactam antibiotics, opioid analgesics) that support existing VistA use cases. It also supports, in a parallel fashion, a logically decomposed set of attributes for all ingredients like mechanism_of_action, physiologic_effect, chemical_structure, and diseases_treated, etc.

The data in NDF-RT^TM is modeled using various types of relationships to represent the semantics between information at different levels in its hierarchy. NDF-RT^TM is also linked with various external national standards like RxNorm, FDA UNII, MeSH^® and HL7.  NDF-RT^TM classes drugs in a complex web of semantics. Two of the classification schemes (Mechanism of action and Physiological effects) have been adopted as CHI standards as part of CHI Medications sub domain. NDF-RT^TM’s active ingredients hierarchy was initialized from MeSH^® and is synchronized with the same at regular intervals. Concepts in this hierarchy are differentiated from the other concepts by a Ingredient_Kind designation. The following information for Ingredient_Kind concepts is stored in NDF-RT™.

• MeSH^®_Name
• MeSH^®_UI
• MeSH^®_Definition
• FDA_UNII
• RxNorm_CUI
• RxNorm_CODE
• RxNorm_UMLS^® CUI

Medical Subject Headings (MeSH^®)

Benefits- MeSH^® offers several advantages as a drug classification scheme for allergy domain. It offers an unrestricted and open license, a publicly accessible change control board, and a wide acceptance and implementation in information systems. Another important advantage of MeSH^® is the multihierarchical arrangement of concepts. This provides the ability to support different use cases of legacy systems. For example, ampicillin is categorized as a penicillin, beta lactam, 2-ring heterocyclic compound and a bridged ring heterocyclic compound. While the association of ampicillin as a penicillin is useful in allergy checking, the relationship to beta lactams group could support drug resistance checking.

NDF-RT™ is distributed by without restriction.

Summarize the degree of market penetration today; i.e., where is this solution installed today?

None to date

What number of or percentage of relevant vendors have adopted the standard?

None to date

What number or percentage of healthcare institutions have adopted the standard?

None to date

What number or percentage of federal agencies have adopted the standard?

100% of federal agencies have adopted the NDF-RT™ as their standard mechanism of action and physiological effect through the White House’s Consolidated Health Informatics initiative. 

Is the standard used in other countries?

None to date

Are there other relevant indicators of market acceptance?

There are no additional relevant indicators of market acceptance.

Department/Agency

B

C

D

E

F

G

Department of Veterans Affairs (VA)

Y

Y

Y

B

Patient Care

Department of Defense (DOD

Y

Y

Y

B

Patient Care

HHS Office of the Secretary

Administration for Children and Families (ACF)

Administration on Aging (AOA)

Agency for Healthcare Research and Quality (AHRQ)

Agency for Toxic Substances and Disease Registry (ATSDR)

Centers for Disease Control and Prevention (CDC)

Centers for Medicare and Medicaid Services (CMS)

Y

Y

Y

B

Benefits

Food and Drug Administration (FDA)

Y

Y

Y

B

SPL; DARRTS; AERS; SPOTS

Regulation, Research

Health Resources and Services Administration (HRSA)

Indian Health Service (IHS)

Y

Y

Y

B

Patient Care

National Institutes of Health (NIH)

Y

Y

Y

B

Clinical Trials

Substance Abuse and Mental Health Services Administration (SAMHSA)

Social Security Administration (SSA)

Department of Agriculture (DOA)

Department of State (DOS)

US Agency for International Development (USAID)

Department  of Justice (DOJ)

Department of Treasury (DOT)

Department of Education (DOE)

General Services Administration

Environmental Protection Agency

N

Y

N

Information Steward

Department of Housing & Urban Development (HUD)

Department of Transportation (DOT)

Department of Homeland Security (DHS)

Number of Terms

Quantify the number of vocabulary terms, range of terms or other order of magnitude.
Approximate numbers of values per vocabulary:
Allergen Type 20
Allergen Severity 10
Allergen Reaction 330
Drug Substance Codes (active ingredients 2000; active moieties 1000, inactive ingredients 5000)
Non-Drug Substance Codes-607
Vaccine Substance Codes -27
Botanicals Codes -750
Drug Classifications-3753 (includes all concepts from MeSH^® Chemical Structure hierarchy in NDF-RT™ not only drug classes
Food Classification-8

How often are terms updated?

HL7^® v2.x standards are issued every two to three years.  HL7^® V 3 vocabulary tables are updated three times per year.

FDA SRS terms are added daily, and updated as necessary throughout each year.  The terms can be reviewed several times a year as requested.

EPA SRS The data in the SRS is periodically updated with new EPA regulations and program system lists. EPA and FDA are developing process to update each agency’s SRS’.

RxNorm Monthly releases

SNOMED CT^®  Semiannually (January 31^st and July 31^st)

NDF-RT™ updated with MeSH^® annually.

Range of Coverage

Within the recommended vocabulary, what portions of the standard are complete and can be implemented now? (300 words or less)

HL7^® 2.x is currently available for information exchange. The HL7^® v3 Allergy Reference Information Model is in available but not widely tested.

Once the SPL data (including the UNII code portion) has been submitted by the FDA to NLM for distribution in the DailyMed^®, that data will also be incorporated into RxNorm

RxNorm maintains Brand Name information but no vocabulary can be complete.  Drug vocabulary, in particular, is constantly changing, with new ingredients, new dosage forms, and new strengths.  RxNorm contains all the clinical drugs contained in the other vocabularies, and has an update model. With the understanding as stated, it is ready for implementation in its coverage of prescription drugs.  It remains incomplete for multi-ingredient OTC preparations (e.g., multivitamins) and contrast media.

A new version of NDF-RT™, planned for 2006 or later, will be submitted to NLM and included in UMLS^®.

Acquisition

How are the data sets/codes acquired and use licensed?

Standards are available from HL7^®.  HL7^® asserts and retains copyright in all works contributed by members and non-members relating to all versions of the Health Level Seven^® standards and related materials, unless other arrangements are specifically agreed upon in writing. No use restrictions are applied.

Each recommended vocabulary standard is available as noted in the vocabulary standards section.

Cost

What is the direct cost to obtain permission to use the data sets/codes? (licensure, acquisition, other external data sets required, training and education, updates and maintenance, etc.)

HL7^® sells hard and computer readable forms of the various standard versions, cost from $50 - $500 depending on specific standard and member status. Draft versions of standards are available to all from their website. No specific cost is associated with using the standards.

Training is offered through HL7^® and others are varying costs from several hundred to several thousand-dollars/per person. Consultation services are available at standard industry cost for training, update instillation and maintenance.

FDA SRS is available free of charge through SPL and DailyMed^®.  It is then also made public through the NLM and NCI, and incorporated into the USP Dictionary of USAN and International Drug Names (a.k.a., ‘USAN’). RxNorm and SPL is available free of charge through the UMLS^®.

EPA SRS is available free of charge through EPA website. Enhanced capabilities are currently being redesigned to improved access to the EPA SRS.

RxNorm is available free of charge through NLM UMLS^®

NDF-RT™ is available free of charge through NCI

SNOMED CT^®  is available free of charge through NLM UMLS^®

Systems Requirements

Is the standard associated with or limited to a specific hardware or software technology or other protocol?

No

Guidance

What public domain and implementation and user guides, implementation tools or other assistance is available and are they approved by the SDO?

HL7^® is in widespread use and has many implementation guides and tools, some in the public domain and some accessible by authorized personnel or organizations.  Please refer to www.hl7.org for more details.

Full implementation conformance requirements for interoperability will need to be developed between exchanging partner built of the HL7 and additional vocabulary standards being recommended.

Is a conformance standard specified?  Are conformance tools available?

A standard is not specified. Conformance tools are not available through the SDO, but private sector tools do exist.

Maintenance

How do you coordinate inclusion and maintenance with the standards developer/owners?

Voluntary upgrade to new versions of standards, generally by trading partner agreement. Messages are transmitted with version number and use of prior versions is generally supported for a period of time after introduction of a new one.

What is the process for adding new capabilities or fixes?

The process for adding new capabilities or fixes is addressed at the individual Standards Development Organization.

What is the average time between versions?

Various, but approximately annually.

What methods or tools are used to expedite the standards development cycle?

None. The methods or tools used to expedite the standards development cycle is addressed at the individual Standards Development Organization (SDOs). Some SDOs conduct standard development meetings up to three times yearly, as well as in the workgroups between meetings.  The standards development is often a lengthy process. lengthy.

How are local extensions, beyond the scope of the standard, supported if at all?

For HL7, yes, but not encouraged (Z segment)

Customization

Describe known implementations that have been achieved without user customization, if any. 

None.

If user customization is needed or desirable, how is this achieved? (e.g, optional fields, interface engines, etc.) 

Free text fields are available bit not recommended.

Mapping Requirements 

Describe the extent to which user agencies will likely need to perform mapping from internal codes to this standard.

Because implementation of the CHI adopted standards is prospective, user agencies will need to perform mapping from internal codes to the allergy standards only in new systems and systems undergoing major upgrades.

Identify the tools available to user agencies to automate or otherwise simplify mapping from existing codes to this standard.

The NCI has already begun mapping the FDA SRS to its own databases, and it is anticipated that USP and NLM will also do the same.

United States Health Information Knowledgebase (USHIK) is designing a portal to provide access to all CHI Standards. NLM UMLS^® provide information for terminology mapping.

Conformity with other Standards

Yes (100%)

No (0%)

Yes with exception

HIPAA Transaction and Code Set Standards

X

HL7^® 2.4 and higher

X

Implementation Timeframe

Estimate the number of months required to deploy this standard; identify unique considerations that will impact deployment schedules.

Any estimate would differ by agency, due to the legacy systems currently in. In order to determine the compatibility of the standards, use cases need to be done, to look at all intended uses of allergy terminology being addressed. 

If some data sets/code sets are under development, what are the projected dates of completion/deployment?

As of March 2006, the FDA has completed entering 100% of active ingredients for approved and marketed prescription drug products, 60% of over the counter and 99% of vitamins and minerals into the FDA SRS. It is anticipated that by October 2006, all vitamins and minerals will be added into the FDA SRS, as will the most common inactive ingredients that are in approved and marketed prescription drug products.

By August 2006, it is anticipated that active ingredients for common food allergens and botanicals/herbals will be entered into the FDA SRS.

By December 2008, it is anticipated that the FDA SRS will be loaded with

• active ingredients for all over the counter drugs
• active ingredients for biologics, food nutritional supplements
• inactive ingredients (including dyes) for drugs, food (that are known to cause an allergic response) and biologics

Gaps

Identify the gaps in data, vocabulary or interoperability.

Any other required federal standards that should emerge will require a harmonization between HL7^® and the vocabulary recommended standards identified.

Availability of the UNII codes within the FDA SRS for all aspects (active ingredients, inactive ingredients, dyes) of drugs (prescription, OTC, herbals), biologics and food is progressing as noted in deployment schedule above. Since this is the basis of the Allergen recommendation, it is recommended that the FDA SRS UNII code availability be aggressively completed not only for all inactive ingredients that are in approved and marketed prescription drugs, but also for active and inactive ingredients that are in OTC drugs, cosmetics, foods, herbal products, and biologics. The furthest projected completion date at this point in time would be December 2008.

A new version of NDF-RT™ will be submitted to NLM (planned for Summer 2006) to be included in UMLS^® and will be made publicly available through a simple download mechanism.

The Allergy Type codes and descriptions available in SNOMED should be reviewed and refined as necessary. It would be advantageous if all Allergy Reaction codes could hierarchically descend from a common concept. Current Allergy Reaction Codes as identified on the VA/DoD recommended allergen reaction list cross hierarchies, and so must be enumerated individually.

A general approach to specifying and maintaining subsets drawn from SNOMED or other vocabularies has not been fully worked out. Such a process would indicate the organization maintaining the subset, the specific collection of concepts in the subset, the manner of distribution of such a subset and its updates, and other such metadata related to the subset.

Obstacles

What obstacles, if any, have slowed penetration of this standard? (technical, financial, and/or cultural)

To date, there has been no available vocabulary to support standardized Allergy content of the HL7 transaction, particularly as it is related to the allergen code. In addition, this is a complex but crucial areas for patient safety and medical errors. The immaturity of related standards to support this domain is being addressed by involved agencies including FDA and NLM. The VA and DOD as large healthcare providers have piloted efforts to share allergy data. The extent of this sharing is limited by the incomplete status of many of the allergen related vocabulary. To fill this gap, the VA and DOD have compiled allergen related vocabularies which are being pointed to SNOMED^® codes and incorporated into the FDA SRS. The FDA is working to establish a complete set of Unique Ingredient Identifiers for drug, biologics, cosmetics, herbal products, food and non drug/food allergen. This FDA effort has already begun with the expected completion of all common allergen codes by December 06 and all ingredients by December 2008.

With numerous systems currently deployed throughout the government, the cost to convert to a new version of HL7^® is high.  Furthering the difficulties are the legacy issues that still need to be addressed.

While the team supports the use of HL7^® messaging standards for allergy transactions, it notes that a large gap exists between the message standard and the ability to currently code allergen contents of the message. Version 2.x HL7^® messages are currently implemented with a high degree of variability in content of the elements. Some of this difference relates to the use of local codes or non-standard use of publicly available codes and some involves subtle differences in the interpretation of the element’s meaning. The vocabulary standards recommended in this report attempt to address these obstacles.

Version 3 of HL7^® has a goal of increasing the ability to understand a received message by addressing these two broad issues through the use of an XML message structure and a Reference Information Model (RIM), though this has not been demonstrated. The acceptance of the message standard without standardization of code sets between users will not result in increased interoperability and a large gap will exist.

The Allergy Work Group also encourages the continual developmental efforts to improve access tools to the recommended standards.

Information Exchange Requirement

Description of IER

Beneficiary Financial / Demographic Data

Beneficiary financial and demographic data used to support enrollment and eligibility into a Health Insurance Program.

Beneficiary Inquiry Information

Information relating to the inquiries made by beneficiaries as they relate to their interaction with the health organization.

Beneficiary Tracking Information

Information relating to the physical movement or potential movement of patients, beneficiaries, or active duty personnel due to changes in level of care or deployment, etc.

Body of Health Services Knowledge

Federal, state, professional association, or local policies and guidance regarding health services or any other health care information accessible to health care providers through research, journals, medical texts, on-line health care data bases, consultations, and provider expertise. This may include: (1) utilization management standards that monitor health care services and resources used in the delivery of health care to a customer; (2) case management guidelines; (3) clinical protocols based on forensic requirements; (4) clinical pathway guidelines; (5) uniform patient placement criteria, which are used to determine the level of risk for a customer and the level of mental disorders (6) standards set by health care oversight bodies such as the Joint Commission for Accreditation of Health Care Organizations (JCAHO) and Health Plan Employer Data and Information Set (HEDIS); (7) credentialing criteria; (8) privacy act standards; (9) Freedom of Information Act guidelines; and (10) the estimated time needed to perform health care procedures and services.

Care Management Information

Specific clinical information used to record and identify the stratification of Beneficiaries as they are assigned to varying levels of care.

Case Management Information

Specific clinical information used to record and manage the occurrences of high-risk level assignments of patients in the health delivery organization..

Clinical Guidelines

Treatment, screening, and clinical management guidelines used by clinicians in the decision-making processes for providing care and treatment of the beneficiary/patient.

Cost Accounting Information

All clinical and financial data collected for use in the calculation and assignment of costs in the health organization.

Customer Approved Care Plan

The plan of care (or set of intervention options) mutually selected by the provider and the customer (or responsible person).

Customer Demographic Data

Facts about the beneficiary population such as address, phone number, occupation, sex, age, race, mother's maiden name and SSN, father's name, and unit to which Service members are assigned

Customer Health Care Information

All information about customer health data, customer care information, and customer demographic data, and customer insurance information. Selected information is provided to both external and internal customers contingent upon confidentiality restrictions. Information provided includes immunization certifications and reports, birth information, and customer medical and dental readiness status

Customer Risk Factors

Factors in the environment or chemical, psychological, physiological, or genetic elements thought to predispose an individual to the development of a disease or injury. Includes occupational and lifestyle risk factors and risk of acquiring a disease due to travel to certain regions.

Encounter (Administrative) Data

Administrative and Financial data that is collected on patients as they move through the healthcare continuum. This information is largely used for administrative and financial activities such as reporting and billing.

Improvement Strategy

Approach for advancing or changing for the better the business rules or business functions of the health organization. Includes strategies for improving health organization employee performance (including training requirements), utilization management, workplace safety, and customer satisfaction.

Labor Productivity Information

Financial and clinical (acuity, etc.) data used to calculate and measure labor productivity of the workforce supporting the health organization.

health organization Direction

Goals, objectives, strategies, policies, plans, programs, and projects that control and direct health organization business function, including (1) direction derived from DoD policy and guidance and laws and regulations; and (2) health promotion programs.

Patient Satisfaction Information

Survey data gathered from beneficiaries that receive services from providers that the health organization wishes to use to measure satisfaction.

Patient Schedule

Scheduled procedure type, location, and date of service information related to scheduled interactions with the patient.

Population Member Health Data

Facts about the current and historical health conditions of the members of an organization. (Individuals' health data are grouped by the employing organization, with the expectation that the organization's operations pose similar health risks to all the organization's members.)

Population Risk Reduction Plan

Sets of actions proposed to an organization commander for his/her selection to reduce the effect of health risks on the organization's mission effectiveness and member health status. The proposed actions include: (1) resources required to carry out the actions, (2) expected mission impact, and (3) member's health status with and without the actions.

Provider Demographics

Specific demographic information relating to both internal and external providers associated with the health organization including location, credentialing, services, ratings, etc.

Provider Metrics

Key indicators that are used to measure performance of providers (internal and external) associated with the health organization.

Referral Information

Specific clinical and financial information necessary to refer beneficiaries to the appropriate services and level of care.

Resource Availability

The accessibility of all people, equipment, supplies, facilities, and automated systems needed to execute business activities.

Tailored Education Information

Approved TRICARE program education information / materials customized for distribution to existing beneficiaries to provide information on their selected health plan. Can also include risk factors, diseases, individual health care instructions, and driving instructions.

Acronym

Description

ACF

Administration for Children and Families

AERS

Adverse Event Reporting System

AHFS

American Hospital Formulary Service

AHRQ

Agency for Healthcare Research and Quality

ANA

American Nurses Association

ANSI

American National Standards Institute

AOA

Administration on Aging

ATC

Anatomical Therapeutic Chemical Classification

ATSDR

Agency for Toxic Substances and Disease Registry

AVMA

American Veterinary Medical Association

CAP

College of American Pathologists

CAS

Chemical Abstract Service

CDC

Centers for Disease Control and Prevention

CHDR

Clinical Health Data Repository

CMS

Centers for Medicare and Medicaid Services

CRADA

Cooperative Research and Development Agreement

DARRTS

Document Archiving, Reporting and Regulatory Tracking

DHS

Department of Homeland Security

DOA

Department of Agriculture

DOD

Department of Defense

DOE

Department of Education

DOJ

Department  of Justice

DOS

Department of State

DOT

Department of Treasury

DOT

Department of Transportation

DTS

Distributed Terminology System

EAFUS

Everything Added to Foods in the United States

EMEA

European Agency for the Evaluation of Medicinal Products

EVS

Enterprise Vocabulary Services

EPA

Environmental Protection Agency

EPA SRS

Environmental Protection Agency Substance Registry System

FAET

Federal Adverse Events Task Force

FALCPA

Food Allergen Labeling and Consumer Protection Act

FDA

Food and Drug Administration

FDA SRS

Food and Drug Administration Substance Registration  System

FDB

First Data Bank

GCPR

Government Computer-Based Patient Record

GSA

General Services Administration

HEDIS

Health Plan Employer Data and Information Set

HHS/DHSS

Department of Health and Human Services

HIPAA

Health Insurance Portability and Accountability Act

HL7^®

Health Level Seven^® (HL7^®)

HRSA

Health Resources and Services Administration

HUD

Department of Housing & Urban Development

IERs

Information Exchange Requirements

IHS

Indian Health Service

INN

International Nonproprietary Names

IUIS

International Union of International Societies

IUPAC

International Union of Pure and Applied Chemistry

JCAHO

Joint Commission for Accreditation of Health Care Organizations

LanguaL

Langua aLimentaria; Language of Foods

MeSH

Medical Subject Heading

NASA

National Aeronautics and Space Administration

NCI

National Cancer Institute

NCPDP

National Council for Prescription Drug Programs

NDC

National Drug Code

NDF-RT™

National Drug File Reference Terminology

NEHTA

National E-Health Transition Authority, Australia

NIH

National Institutes of Health

NLM

National Library of Medicine

OASD(HA)

Office of the Assistant Secretary of Defense for Health Affairs

RxNorm

National Library of Medicine standardized nomenclature for clinical drugs

SAMHSA

Substance Abuse and Mental Health Services Administration

SDOs

Standards Development Organization

SNOMED^®

Systematized Nomenclature of Medicine

SNOMED CT^®

Systematized Nomenclature of Medicine Clinical Terms

SPL

Structured Product Labeling

SPOTS

Special Products On-Line Tracking System

SSA

Social Security Administration

TGA

Therapeutic Goods Administration (Australia)

TRICARE

Health insurance program for military personnel and their families

UMLS^®

Unified Medical Language System

UNII

Unique Ingredient Identifier

USAID

United States Agency for International Development

USAN

United States Adopted Names

USDA

United States Department of Agriculture

USHIK

United States Health Information Knowledgebase

USP

United States Pharmacopeia

USP-NF

United States Pharmacopeia-National Formulary

VA

Department of Veterans Affairs

VHA

Veterans Health Administration

WASPalm

World Association of Societies of Pathology and Laboratory Medicine