MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Introduction

An alarming report issued recently by the Institute of Medicine (IOM) found that adverse drug events injure an estimated 1.5 million people each year, at a cost of approximately $3.5 billion dollars [1]. If these statistics seem inordinately high, consider that the numbers do not factor in lost wages, productivity, or additional health care costs incurred as a result of these injuries.

The National Academies, deeply concerned about the health implications of IOM's findings, urged government agencies, health care professions, and communities to work together to improve patient– provider partnerships, create new and improved drug information resources, and simplify complicated drug naming and labeling.

Background

Injuries and deaths attributed to medication errors and faulty medical devices occurred long before the Vioxx and Celebrex scandals shook the health care industry a few years ago. As the primary governing agency for pharmaceuticals and medical devices in the United States, the Federal Drug Administration (FDA) has a directive to investigate and make public any information associated with adverse medical events caused by the products they approve for use on the market.

To increase the discovery of adverse events in the general population, the FDA created a safety information and adverse event reporting service (AERS) called MedWatch. This service is freely available on the Internet and serves both health care professionals and the medical product–using public. Making MedWatch open and available on the Internet is crucial, considering most Americans are exposed to the potential risks of medical products. In fact, it is estimated that Americans spend an estimated $200 billion a year just on prescription drugs [2].

Purpose

MedWatch serves two main purposes. It offers AERS tools that allow medical professionals and the public to report medication errors and medical product injuries. MedWatch also provides clinical information about prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products, such as medical foods, dietary supplements, and infant formulas.

Description

MedWatch focuses on drug and medical device reporting. It offers a choice between a voluntary reporting form, designed primarily for health care professionals and the general public, and a mandatory AERS reporting form, available to manufacturers, importers, and medical product user facilities that manage and store medical products. The latter group is required by law to submit the mandatory form immediately upon discovery of a product malfunction. Printable mail-in forms are available as an alternative to the online submission.

Review

The process of filling out and submitting the voluntary form is relatively simple. However, some language seems too advanced for the average user. Terms such as “dose frequency,” “medical pathway,” and “event abated” are unnecessarily complicated and possibly intimidating. However, the forms are brief and the user interface is basic, with big buttons, spacious form fields, and large font sizes. The form takes anywhere from ten to twenty minutes to complete, depending on how much detailed information the user wishes to provide.

The drug information section of MedWatch offers fresh news, medication alerts, recall information, and drug labeling changes conveniently delivered via email, through really simple syndication (RSS) or from the What's New section of the Website.

The Drug Labeling section is well organized, allowing users to view changes by month, going back to 2002. The Labeling Changes page allows an at-a-glance look at modified drug information and the specific section on the label that contains modifications. Clicking on the drug provides more detailed information about changes to warnings and contraindications. Content is cleanly displayed, and the language is easy to understand.

Summary

The MedWatch adverse event and reporting system allows anyone to report to the FDA injuries and/or deaths caused by medical products. Submitting a report is easy for the average user and only an Internet connection is required. Additionally, the MedWatch information service provides comprehensive, current information on drug alerts, recalls, and labeling changes and offers a variety of delivery methods including RSS, email, and a Current News section on the Website, which is updated regularly.