Online Program

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

Monday, November 2, 2015

Sarah McCord, MLIS, MCPHS Libraries, MCPHS, Boston, MA
Enrique Seoane-Vazquez, Ph.D., International Center of Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences, Boston, MA
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.

Learning Areas:

Clinical medicine applied in public health
Communication and informatics
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy

Learning Objectives:
Differentiate between the eight types of drug indications currently discussed in the clinical literature. Explain the technological and workflow challenges of designing a data management system to track the occurrence of the eight types of drug indications relevant to the U.S. healthcare system.

Keyword(s): Decision-Making, Information Technology

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: This session does discuss unlabeled or investigational uses in general, but only to illustrate the presence of these uses in the clinical literature.

Qualified on the content I am responsible for because: I am the primary investigator on the Drug Indications Knowledge Management Pilot Project grant used to fund the project discussed in the abstract. I also teach courses in biomedical informatics and chemical information.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.