Development of a data collection, evaluation, and management plan for tracking drug indications described in journal articles

A drug indication contains information about the intended use of a drug for a disease or condition and a set of contraindications, restrictions, and limitations of its use.  There exist several possible indications for a drug in the U.S. health care system. These include: (1) clinical trial indication, (2) FDA approved indication, (3) other agencies from developed economies approved indication; (4) clinical database indication; (5) post-marketing studies indication; (6) health technology assessment indication; (7) clinical guidelines indication; and (8) formulary indication. 

When defining a drug indication in cases 1-4, each decision-making process may use different safety and efficacy criteria. In cases 5-8, other clinical and economic criteria may also be considered. As a result, indications may vary in terms of the disease or condition, contraindications, restrictions and limitations of use.  The existence of these many different indications make it difficult for clinicians, patients, health care payers, and other health care stakeholders to know which type of indication is described in a journal article.  Specifically, a drug indication described in a journal article may not correspond to the indication approved by the FDA, potentially resulting in efficacy and safety problems for patients using these drugs.

Problems derived from the existence of these multiple indications can be reduced if health care stakeholders are able to link those indications to the indications approved by the FDA.  This session outlines the steps taken to create a plan for data collection, evaluation, and management related to the description of drug indications in journal articles.