[Federal Register Volume 78, Number 171 (Wednesday, September 4, 2013)]
[Notices]
[Pages 54469-54470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21434]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Solicitation of Written Comments on Draft National Action Plan 
for Adverse Drug Event Prevention

AGENCY: Office of Disease Prevention and Health Promotion, Office of 
the Assistant Secretary for Health, Office of the Secretary, Department 
of Health and Human Services.

ACTION: Notice.

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SUMMARY: The Office of Disease Prevention and Health Promotion is 
soliciting public comment on the draft National Action Plan for Adverse 
Drug Event Prevention.

DATES: Comments on the draft National Action Plan for Adverse Drug 
Event Prevention must be received no later than 5 p.m. on October 4, 
2013. This document provides an overview of current federal efforts to 
support surveillance, prevention, research, and the use of policy 
levers to reduce adverse drug events across the United States. The 
draft Action Plan reflects the work of many offices across the 
Department of Health and Human Services, Department of Defense, 
Department of Justice, and Department of Veterans Affairs. The draft 
Action Plan also reflects input from national experts.

ADDRESSES: The draft National Action Plan for the Prevention of Adverse 
Drug Events is available at: http://www.hhs.gov/ash/initiatives/ade/ade-action-plan.pdf. Comments are preferred electronically and may be 
addressed to [email protected]. Please use the title ``Draft National ADE 
Action Plan'' when sending comments electronically. Written responses 
should be addressed to the Department of Health and Human Services, 
Office of Disease Prevention and Health Promotion, 1101 Wootton 
Parkway, Suite LL100, Rockville MD 20852, Attention: Draft National ADE 
Action Plan.

FOR FURTHER INFORMATION CONTACT: Yael Harris, Director, Division of 
Health Care Quality, Office of Disease Prevention and Health Promotion, 
240-453-8206, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Adverse drug events (ADEs) have been defined by the Institute of 
Medicine as ``an injury resulting from medical intervention related to 
a drug.'' This broad term encompasses harms that occur during medical 
care that are directly caused by the drug and can include, but are not 
limited to, medication errors, adverse drug reactions, allergic 
reactions, and overdoses. ADEs can occur in any health care setting, 
including both inpatient and outpatient settings and even more likely 
to occur during patient transitions from one health care setting to 
another. ADEs are the single largest contributor to hospital-related 
complications within hospitals and account for over 3.5 million 
physician office visits, approximately 1 million emergency department 
(ED) visits, and an estimated 125,000 hospital admissions every year.
    For these reasons, the reduction of ADEs is a top priority for the 
Department of Health and Human Services (HHS). Multiple Operating and 
Staff Divisions within HHS have been working to reduce the incidence 
and prevalence of adverse drug events for years. To further these 
efforts, in 2012, a Cross-Federal Steering Committee for Adverse Drug 
Event Prevention was established. The Steering Committee was charged 
with developing a comprehensive strategy to significantly reduce 
adverse drug events within the three drug classes which account for a 
significant proportion of all ADEs: anticoagulants, diabetes agents, 
and opioids. The draft Action Plan focuses on four main opportunities 
for federal engagement: surveillance, prevention, incentives and 
oversight, and research.
    The draft Action Plan identifies current federal activity across 
both inpatient and outpatient settings, as well as transitions of care, 
that are related to these four opportunities, with a focus on the three 
drug classes associated with high levels of harm. It also highlights 
opportunities to advance these efforts through cross-federal 
partnerships and coordinated resources.
    The release of the plan is only the beginning of a coordinated 
process that will result in stakeholders who are more engaged, aware, 
and knowledgeable of issues regarding the safe use of prescribed 
medications to prevent ADEs. Although the initial phase of the Action 
Plan reflects primarily the efforts and resources of federal agencies, 
the draft Action Plan was developed with the expectation and 
understanding that outlining ADE prevention goals and, more 
importantly, actually achieving ADE reductions and improving patient 
safety can be considered neither complete nor feasible without further 
engagement of professional organizations representing medical, nursing, 
pharmacy, and other allied health professionals, academia, patient and 
consumer representatives, and other private sector stakeholders. For 
this reason, every opportunity to ensure that feedback of and 
engagement with these entities will be sought through the public 
release of the draft Action Plan. Through coordinated federal 
partnerships, as well as public and private sector collaborations and 
aligned approaches, we can improve the quality and safety of health 
care, reduce health care costs, and improve the health and quality of 
life of millions of people in the United States.

II. Information Request

    The Office of Disease Prevention and Health Promotion, on behalf of 
the HHS Steering Committee for Adverse Drug Event Prevention, requests 
input on the revised draft National Action Plan for Adverse Drug Event 
Prevention.

III. Potential Responders

    HHS invites input from a broad range of individuals and 
organizations that have interests in reducing adverse drug events. Some 
examples of these organizations include, but are not limited to the 
following:
     Caregivers or health system providers (e.g., physicians, 
physician assistants, nurses, pharmacists)
     Collaboratives and consortia
     Foundations
     Health care, professional, and educational organizations/
societies
     Insurers and business groups
     Medicaid- and Medicare-related organizations
     Patients and their advocates
     Pharmaceutical Industry
     Prescription drug monitoring programs
     Public health organizations
     State and local public health agencies.
    When responding, please self-identify with any of the above or 
other categories (include all that apply) and your name. Anonymous 
submissions will not be considered. Written materials submitted for 
consideration should not exceed 10 pages, not including appendices and 
supplemental documents. Responders may submit other forms of electronic 
materials to demonstrate or exhibit concepts of their written 
responses, however, we request that comments are identified by section, 
subsection, and page number so they may be addressed accordingly. All 
comments received

[[Page 54470]]

before the close of the comment period are available for viewing by the 
public, including any personally identifiable or confidential business 
information that is included in a comment.

    Dated: August 28, 2013.
Don Wright,
Deputy Assistant Secretary for Health, Office of Disease Prevention and 
Health Promotion.
[FR Doc. 2013-21434 Filed 9-3-13; 8:45 am]
BILLING CODE 4150-32-P