E9-26530. Food and Drug Administration's Safe Use Initiative; Availability of Information

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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.

DATES:

Submit electronic or written comments at any time.

ADDRESSES:

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 http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section 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 prescription and 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 http://www.fda.gov/​Drugs/​DrugSafety/​ucm187806.htm.

II. Submission of Feedback on the Contents of This Docket

Interested parties may submit to the Division of Dockets Management (see ADDRESSES) 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 http://www.regulations.gov.

Dated: October 30, 2009.

David Horowitz,

Assistant Commissioner for Policy.

Footnotes

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.