This press release was updated on July 21, 2006, to reflect
the correct estimate of product labels that will be available.
FDA Statement
| FOR IMMEDIATE RELEASE
Statement
July 20, 2006 |
Media Inquiries:
FDA Press Office,301-827-6242
Consumer Inquiries:
888-INFO-FDA |
FDA Statement on Institute of Medicine's Report on Preventing Medication Errors
The Food and Drug Administration (FDA) believes the Institute of Medicine report released today provides a much needed perspective on the frequency, severity and preventable nature of medication errors. We find that many of the recommendations outlined in the report are supported by efforts already underway at FDA in the areas of medication error prevention, patient education and label comprehension. We look forward to using the occasion of this report to continue to work with stakeholders and partners to build on these efforts.
- In January, FDA announced a major revision to the format of prescription drug information, commonly called the package insert or physician labeling, to give healthcare professionals clear and concise prescribing information. In an effort to manage the risks of medication use and reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws attention to the most important pieces of drug information before a product is prescribed.
- FDA this week released guidance to industry aimed at making Consumer Medication Information more useful for consumers. While the agency generally does not regulate this information, it is taking steps to provide guidance to improve their usefulness.
- FDA is actively working with the National Council on Patient Information and Education (NCPIE), an organization that has convened interested stakeholders in an effort to improve consumer medication information.
FDA recognizes the importance that good drug naming, labeling and packaging practices have on minimizing medication errors. Prior to approval, we assess the risks associated with a proposed drug name and determine whether it raises any safety concerns. Once drugs are on the market, we monitor the risks that drug names pose if they sound or look similar to those of other drugs as well as how the use of certain abbreviations, acronyms and dose designations contribute to medication errors.
- We are partnering with the Institute on Safe Medication Practices to further refine our review of look-alike, sound-alike drug names, and will continue to evaluate our process before a drug is approved in which a proposed drug name along with its labels and labeling are evaluated for their potential to cause medication errors.
- We plan to issue guidance for industry on drug naming, labeling and packaging as recommended in this report.
In addition, FDA continues to encourage widespread use of technologies that can help healthcare providers avoid medication errors. As part of the President's and Secretary of Health and Human Services Mike Leavitt's commitment, we have worked to advance the federal health effort to create electronic health records for Americans within the next decade by making it easier to share drug information electronically. Further, in support of Secretary Leavitt's priority to reduce debilitating and costly health events, FDA is engaged in a number of activities to provide consumers with information to make sound healthcare decisions.
- In November 2005, FDA began requiring prescription drug labeling information
be submitted in a new searchable electronic format that will allow healthcare
providers and the general public to more easily access drug information.
By the end of this summer, there will be more than 1,000 sets of new electronic
product labeling accessible through the National Library of Medicine (http://dailymed.nlm.nih.gov/dailymed/about.cfm).
- Within the past two years, FDA has been implementing a new rule requiring bar codes on the labels of thousands of human drugs and biological products—an action that could prevent more than 12 million medication errors each year.
- For more than a decade, the agency has been forming partnerships with other federal agencies, professional associations and industry to establish a standard framework for sharing important safety information electronically.
- FDA and AdvaMed, the medical device trade association, are holding risk communication workshops to discuss device safety and what information should be provided to health professionals and patients for informed health care decisionmaking.
- FDA has renewed its collaboration with health professional organizations to improve communications about risk/benefit information.
- This year, FDA convened an internal Bioinformatics Board, a multi-disciplinary panel that will set data and technology standards to automate the communication of important drug safety information across a variety of public and private systems. Current projects include:
- A web-based adverse event reporting system that consolidates adverse event reporting across the agency;
- A standard computerized medical vocabulary system to electronically code important terms, which will provide healthcare professionals with electronic access to health and treatment information; and
- An enhanced fully electronic drug listing system that will give FDA electronic access to information about drug products and manufacturing centers as well as provide the agency with the most up-to-date safety information.
FDA is committed to working with other government agencies, professional and patient groups and industry to continue to reduce the incidence of medication errors through better consumer medical information, improved drug labeling and naming, and through an enhanced electronic health information architecture to ensure that safety information is communicated efficiently and effectively.
####
IOM report: Preventing Medication Errors
RSS Feed for FDA News Releases [what's this?]
Get free weekly updates about FDA press releases, recalls, speeches, testimony and more.
