Standardizing Data Coding in Healthcare

¶ … Coding: Comparing Different Systems

Standardized comparisons are essential when evaluating a new drug. To understand the drug's efficacy relative to other drugs on the market and to place any adverse events in perspective requires an effective and uniform system of comparative analysis. "Coding of patient data is critical in the grouping, analysis, and reporting of data. Coding decisions directly impact submissions for New Drug Applications (NDAs), safety surveillance, and product labeling" (Troung & Li, 2007, p.1). This paper will review a number of the most popular methods of coding data, specifically MedDRA and WHO Drug, and will examine their unique and specific uses. It will also assess attempts to provide greater standardization to the system of conducting research trials.

MedDRA (Medical Dictionary for Regulatory Activities) is the "globally accepted, clinically validated medical terminology used within all phases of the drug development process, including classification of medical events for clinical trials and drug safety" ("Frequently Asked Questions -- MedDRA," 2016). It has been translated into a wide variety of international languages and allows for relatively standardized comparisons between a variety of potential issues which may arise pre-testing, during clinical trials, and after a drug has been approved to the marketplace. MedDRA is specifically designed to facilitate analysis of and comparison of drugs currently under testing or in their nascent stages of acceptance when adverse events may occur.

In contrast, WHO Drug coding is primarily used as a classification system of existing drugs and other pertinent medical treatments. "WHO Drug is a dictionary of medicinal product information. It is used to identify drug names and provides information about a drug's active ingredients and its therapeutic use(s)" ("Frequently Asked Questions -- WHO Drug," 2016). WHO Drug has the ability to classify drugs but is more limited that MedDRA in terms of classifying adverse events and thus is of less utility in coding a drug trial. However, as a dictionary of drug information, "WHO Drug is the de-facto standard within the biopharmaceutical industry for classifying drugs, including prescription drugs, over-the-counter (OTC) medicines, herbal remedies, blood products, diagnostic substances, and biotech products" ("Frequently Asked Questions -- WHO Drug," 2016).

The ability to classify non-pharmaceutical remedies is essential given that these additional treatments can still interact with drugs and impact care. During a clinical trial, MedDRA would be used to monitor incoming results while after a drug had been approved WHO Drug would be used for the coding itself. WHO might also be used to code for specific non-pharmaceutical treatments a patient was taking during a trial (such as patients also taking herbal medications during a drug trial of an antidepressant, versus using MedDRA to classify reported side effectives). Coding for MedDRA overall can be used throughout the development process (Troung & Li, 2007, p.7).