Testimony

Terri C. Meredith, R.Ph.
Multum Information Services
A Cerner Company
3200 Cherry Creek Drive South, Suite 300
Denver, Colorado 80209
303-733-4447 extension 2032

My name is Terri Meredith. I am the Director of Clinical Vocabularies at Multum Information Services, a subsidiary of the Cerner Corporation. My responsibilities for Multum and Cerner include codifying terms for drug vocabularies for clinical drug information systems. I represent both Cerner and Multum today. We appreciate this opportunity to testify and to provide our views as the National Committee on Vital and Health Statistics prepares its report on the development of uniform data standards for patient medical record information and its electronic transmission.

The Cerner Corporation is a leading supplier of clinical and management information and knowledge systems for healthcare organizations in the United States and abroad. We service more than 1,000 clients in the U.S. and around the world. These clients include integrated health delivery systems, community hospitals, ambulatory clinics, physician practices, health management organizations, blood banks, laboratories, and home health agencies.

Multum Information Services focuses on the creation, maintenance, and distribution of drug information. Multum’s clients include the Cerner Corporation and many other private and public organizations. Over 2000 organizations, including electronic medical record system providers, physician offices, hospitals, insurance companies, and government organizations, license drug and drug product information from us. Multum’s drug terminology is a referenced vocabulary in standards produced by the National Council on Prescription Drug Programs (NCPDP) and is being incorporated into the Unified Medical Language System of the National Library of Medicine.

Multum provides drug product information at multiple levels of granularity to address the business needs of our clients.

As you know, in the United States, even the most general term used to describe a drug, its generic name, has not been codified in a way that promotes interoperability. In a healthcare setting, use of the generic name can provide information to clinicians about the pharmacological properties of a drug. This information includes interactions with other drugs, detection of allergies, recognition of therapeutic duplication, and facts about the drug’s pharmacology, dosing, side effects, and warnings. Such general terms are not appropriate, however, for describing a drug that is to be ordered, prescribed, or included in an electronic patient medical record. The generic drug name must be paired with strength, dose form, and route to provide enough information to match the drug with a drug product that can be administered.

We, like many organizations in our industry, have faced significant business challenges in the area of medical vocabularies. The problem is not necessarily the absence of standards, but more often, the proliferation of numerous, disparate, and incomplete “pseudo-standards” that lack either the clinical depth or industry-wide acceptance needed to facilitate interoperability.

Current drug information available from non-commercial sources is based only on National Drug Codes (NDCs), a system of drug product nomenclature that has serious deficienies. Information based on National Drug Codes is so unreliable and inconsistent from one NDC “source” to another that standard message formats like NCPDP generally require an indication of the source of the NDC used in the message. Other shortcomings of the National Drug Code System include:

While NDCs may be an appropriate system of nomenclature (even given their deficiencies) for certain types of uses like the manufacture, sale, and regulation of bulk and packaged drug products, NDCs are not an appropriate nomenclature for clinical practice. For example, when a physician prescribes a drug for a patient, and that information is placed into either a printed or electronic medical record, the information concerning the prescribed drug is conveyed at a general level. An example of this information is “penicillin VK 250 mg oral tablet”. This level of drug description is very similar to the description of a drug product used by the Health Care Financing Administration to publish Federal Upper Limit Pricing for Drugs. This general information about a drug that is prescribed currently is not interoperable with any other terminology and can only be sent as a coded message to systems that utilize the same drug vocabulary provider. Any other type of messaging must be conveyed as text. Since the dispensing pharmacist ultimately determines the actual product that will be used to fill the prescription order, an accurate representation of the NDC-based drug terminology can be produced only at that point.

We believe that the healthcare informatics community needs a reference terminology for drugs-a “Drug-RT”, in the words of one of our industry counterparts. A Drug-RT should contain generic drug name information, as well as modifiers for strength, dose form, and route of administration. Most drug information providers and standards organizations generally agree that this set of terms provides a basis for interoperability.

The principal impediment towards the development of a drug reference terminology is not what should be done, but how and by whom this terminology should be developed.

The establishment of a federally supported set of drug reference terminology would provide a level playing field where all standards organizations and drug vocabulary providers could guarantee interoperability.

We believe that establishment of a Drug-RT is achievable in the short term, over one to four years. Maintenance and update of the drug reference terminology is not a labor-intensive undertaking. As an example, a survey of new drug approvals by the FDA in all of 1998 showed that only thirty new generic entities and three new dose forms would require an addition to the drug reference terminology. If the need exists, development of additional terminology, such as a drug categorization scheme or inclusion of billing codes can be developed over the long term.

The Federal Government can approach the development of a standardized drug reference terminology in several ways:

  1. The Federal Government could encourage the medical informatics community to create a drug reference terminology. After years of work, this has not come to fruition. If this course of action is pursued, the Federal Government should provide a leadership role.
  2. The Federal Government could create and maintain this terminology. By creating a drug reference terminology and requiring its use in messages sent to government agencies, a standard for representing drug nomenclature would be created.
  3. The Federal Government can create a partnership with the drug informatics community to create the drug reference terminology using collaborative efforts. This method may be preferable, because it provides for input from many sources and may produce a “well-rounded” terminology that takes into account the needs and views of many users and providers of drug-related terminology.

We believe that establishment of a standard drug terminology is essential to the successful deployment of electronic patient records.

We believe that there is no “code set problem” posed by HIPAA that would benefit more from strong governmental leadership. We urge this committee and all Federal agencies involved in the implementation of HIPAA to work toward the selection or creation of a standard reference terminology for drugs for the benefit of all drug-consuming Americans.