Health Services and Outcomes Research Methodology

, Volume 13, Issue 1, pp 58-67

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

Applying standardized drug terminologies to observational healthcare databases: a case study on opioid exposure

  • Frank J. DeFalcoAffiliated withJanssen Pharmaceutical Research & Development Email author 
  • , Patrick B. RyanAffiliated withJanssen Pharmaceutical Research & Development
  • , M. Soledad CepedaAffiliated withJanssen Pharmaceutical Research & Development


Observational healthcare databases represent a valuable resource for health economics, outcomes research, quality of care, drug safety, epidemiology and comparative effectiveness research. The methods used to identify a population for study in an observational healthcare database with the desired drug exposures of interest are complex and not consistent nor apparent in the published literature. Our research evaluates three drug classification systems and their impact on prevalence in the analysis of observational healthcare databases using opioids as a case in point. The standard terminologies compiled in the Observational Medical Outcomes Partnership’s Common Data Model vocabulary were used to facilitate the identification of populations with opioid exposures. This study analyzed three distinct observational healthcare databases and identified patients with at least one exposure to an opioid as defined by drug codes derived through the application of three classification systems. Opioid code sets were created for each of the three classification systems and the number of identified codes was summarized. We estimated the prevalence of opioid exposure in three observational healthcare databases using the three defined code sets. In addition we compared the number of drug codes and distinct ingredients that were identified using these classification systems. We found substantial variation in the prevalence of opioid exposure identified using an individual classification system versus a composite method using multiple classification systems. To ensure transparent and reproducible research publications should include a description of the process used to develop code sets and the complete code set used in studies.


Observational databases Classification systems Coding standards Drug exposures OMOP