A strategic view of adverse event coding.

In April, FDA announced that adverse event concepts represented in the Highlights Section of the Structured Product Label, as part of the new Physicians Labeling Rule, must be "code-able" to a term within a subset of the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT) referred to as the "Problem List Subset".

This announcement generated considerable confusion within the pharmaceutical industry, particularly among data management and labeling departments. Among the concerns generated was the impact this announcement would have on the use of MedDRA, a terminology and dictionary widely used in industry for "coding" of adverse events for regulatory reporting.

Many viewed this action by FDA as a burden on industry, since it was interpreted as suggesting the need to revamp information systems used in adverse event data collection and management. Despite this confusion, this action by FDA provides industry an opportunity to consider its strategy concerning terminology management in its information systems and the role that other standardized coding systems might play in managing safety relevant data.

SNOMED CT is a highly developed and very "fine-grained" medical terminology that has been under intense expert development for many years. It has been viewed as having the potential to serve as the standard medical concept representation system for electronic health records, and has been officially recognized as such in information systems supporting government-sponsored health care activities.

Knowledge and understanding of SNOMED CT and a fresh look at the role and robustness of coding systems would be advantageous for industry. As a first step in understanding how to leverage modern health care coding systems for industry-related needs, one should understand that "coding" systems are not "religion."

The ultimate goal is to leverage each and every coding system based on the business cases and needs that emerge. Interest in and/or use of SNOMED CT does not mean that MedDRA needs to be replaced or that it serves industries less well than SNOMED CT might.

An ideal approach would be to have core set of terminology services and capabilities that enable cross-mapping of multiple terminologies, serving up the code set that represents the intended concept according to business requirements. Hence, for labeling purposes, a terminology support system can mange the representation of concepts within the Structured Product Label while at that same time support MedDRA coding based for other needs.

SNOMED CT has the advantage of fine-grained logical concept representation such that the expressivity is more specific. Each concept in SNOMED CT has a "definition" that is based on the formal relationships between and among the terms within SNOMED CT. This enables more consistent coding across multiple users. Because SNOMED CT has inherent logic it is also suitable for use in technologies that leverage natural language processing for automated coding.

The inherent logic in SNOMED CT also provides the potential for explicit rules that might support auto-coding into MedDRA. SNOMED CT can potentially provide fine-grained coding of concepts within the narrative of adverse event safety reports, enabling more sensitive and specific analytics of those reports.

Industry should begin to gain better understanding of emergence of highly comprehensive, detailed, and logic-based terminologies as part of their forward thinking information management strategies, especially those strategies that involve the leveraging of information for electronic health records.

Alex Ruggieri is the Chief Medical Officer and Senior Director for Safety Solutions with Cerner Corporation in its Cerner Galt division. Dr. Ruggieri has extensive experience in the regulatory and risk management aspects of the therapeutics and device development industry. He has directed and managed a therapeutic area within a large biotechnology company and also served as a director for information management and strategy in safety and regulatory affairs. He has a masters in public health and completed a medical informatics fellowship at Mayo Clinic, where he worked on terminology management in automated systems, text mining and creation of clinical data warehouses to support data mining and hypothesis exploration from electronic medical records. He received his M.D. from Georgetown University and his masters in public health from Johns Hopkins University. Dr. Ruggieri joined Cerner in September of 2006 to join in Cerner initiatives to bring the power of data emerging from robust electronic health information repositories to stakeholders in the therapeutics industry. Dr. Ruggieri leads the Medical and Data Services Division of Cerner Galt and also contributes to technological solutions development in the therapeutics and drug safety arenas. Dr. Ruggieri's main focus is enabling the development and access of clinical data stores to support risk management and safety assessment business cases in the therapeutics development industry.

Dr. Ruggieri will be speaking on SNOMED-CT at a one-hour ExpertBriefings.com audioconference, Wed. May 9, 2 p.m. EDT. To register, call [phone] or visit www.ExpertBriefings.com