Safe Use Initiative; Availability of Information

This Notice document was issued by the Food and Drug Administration (FDA)

For related information, Open Docket Folder  Docket folder icon

Food and Drug Administration
[Docket No. FDA-2009-N-0526]

Food and Drug Administration's Safe Use Initiative; Availability of Information


Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing the launch of its Safe Use Initiative with the release of a report titled “FDA's Safe Use Initiative—Collaborating to Reduce Preventable Harm from Medicines.” FDA is opening a docket to enable the public to comment on the report and the initiative. In addition, a safe use Web site has been created to facilitate transparency as the initiative moves forward. The initiative proposes a series of next steps, including working with interested partners—patients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, and other Federal agencies—to select specific candidate cases of preventable, drug-related harm for analysis, intervention proposals, and evaluation metrics. The report identifies some specific areas of concern that could benefit from Safe Use Initiative partnerships.


Submit electronic or written comments at any time.


Submit written comments on the information in this docket to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. Submit electronic comments to See theSUPPLEMENTARY INFORMATIONsection for electronic access to the information.

For Further Information Contact

Karen Weiss, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 51, rm. 6122, Silver Spring, MD 20993, 301-796-5400.

Supplementary Information

I. Background

Tens of millions of people in the United States depend on prescriptionand over-the-counter (OTC) medications to stay healthy. Yet it is widely known that too many people incur preventable injury and even die from medication errors or misuse. Preventable injuries can result from a variety of sources, including informational errors (mistakes made in prescribing or using a medicine because of inadequate information); unintended, or accidental exposure; intentional drug misuse and abuse; and rarely because of manufacturing and/or distribution defects. The Institute of Medicine (IOM) estimates that 1.5 million preventable injuries, or adverse drug events, occur in the United States healthcare system each year, 1,2 at a cost exceeding $4 billion annually. Additionally, incorrect use of OTC medications results in thousands of preventable injuries. Furthermore, unintended exposure to medications causes a significant number of injuries and deaths, mainly in children. Between 2003 and 2006 alone, more than 9,000 children were accidentally exposed to prescription opioid drugs. 3

These potentially avoidable injuries and deaths represent our society's collective failure to adequately manage medication risks. Because the shortcomings in the healthcare system have been broadly acknowledged, FDA and many other healthcare stakeholders have been working hard to improve the way in which the nation's healthcare system manages medication risks. However, much more needs to be done, and coordinated cross-sector efforts, involving all stakeholders, would have the greatest impact.

To this end, FDA is launching the Safe Use Initiative, through which it will collaborate with stakeholders—including patients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, and Federal agencies—to identify specific candidate cases associated with important, measurable amounts of preventable harm. In the coming months, FDA plans to develop, through extensive consultation with all interested public and private stakeholders, a general list of candidate cases for collaborative analysis and intervention. FDA also intends to work with federal partners to develop population-based national estimates of preventable harm from medications, categorized by drug, drug classes, and therapeutic situations. In addition to opening a docket to receive public input, FDA plans to hold a series of public meetings to gather broad public feedback as the candidate list is being developed. It is FDA's goal to implement a small number of interventions during the next 12 months.

For more information, see FDA's Safe Use Web page at

II. Submission of Feedback on the Contents of This Docket

Interested parties may submit to the Division of Dockets Management (seeADDRESSES) electronic or written comments on this information. Submit a single copy of electronic comments or two paper copies of any mailed comments. Individuals may submit one paper copy. Comments should be identified with the docket number found in brackets in this document's heading. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will accept electronic comments or submissions only at

Dated: October 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26530 Filed 11-4-09; 8:45 am]


(1) Institute of Medicine of the National Academies, Preventing Medication Errors, National Academies Press, p. 124, 2007.

(2) Ibid, p. 4. The IOM defines an adverse drug event (ADE) as any injury due to medication. Examples include a wrong dosage leading to injury (e.g., rash, confusion, or loss of function) or an allergic reaction occurring in a patient not known to be allergic to a given medication.

(3) Bailey, J.E., E. Campagna, R.C. Dart, “The Underrecognized Toll of Prescription Opioid Abuse on Young Children,”Annals of Emergency Medicine, 53:4129-24, 2009.

ID: FDA-2009-N-0526-0001
View original printed format:

Document Information

Date Posted: Nov 5, 2009
Federal Register Number: E9-26530
Show More Details  


Comments Received*
I am writing this comment in hopes to have the drug DEXTROMETHORPHAN removed from the shelves and put up with the PSEUDOPHEDRINE. The dollar stores and 99 cent...
I have a huge concern about the patient's I deal with at an Addiction Research Treatment clinic. We treat people with opiate addictions. We prescribe and dose...
Please require that all medicines be made gluten free, whenever possible. Require that medicines be clearly labeled "Gluten free," or "contains gluten."

Docket Information

This document is contained in
Related Dockets: None
Related RINs: None
Related Documents: None
Related Comments:

* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.

Document text and images courtesy of the
Federal Register