[Federal Register Volume 74, Number 213 (Thursday, November 5, 2009)]
[Notices]
[Pages 57319-57320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0526]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

[[Page 57320]]

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\
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    \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.
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    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.
[FR Doc. E9-26530 Filed 11-4-09; 8:45 am]
BILLING CODE 4160-01-S