81 FR 72594 - Request for Comments on the Proposed Measures and 2020 Targets for the National Action Plan for Adverse Drug Event Prevention: Inpatient and Outpatient Measures for Reduction of Adverse Drug Events From Anticoagulants, Diabetes Agents, and Opioid Analgesics

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 203 (October 20, 2016)

Page Range		72594-72595
FR Document		2016-25424

The Office of Disease Prevention and Health Promotion (ODPHP), on behalf of the U.S. Department of Health and Human Services (HHS) Federal Interagency Steering Committee for Adverse Drug Events, proposes new measures and targets for adverse drug events (ADEs) from anticoagulants, diabetes agents, and opioid analgesics for the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). Based on input from the Federal Interagency Workgroups for Adverse Drug Events, six national measures and targets for the reduction of ADEs are being proposed. Each drug class highlighted in the ADE Action Plan (anticoagulants, diabetes agents, and opioid analgesics) includes a proposed inpatient and outpatient measure to track national progress in reduction of ADEs from these drug classes. The proposed targets will reflect improvement efforts over a four to six year period since the release of the ADE Action Plan in August 2014. As such, HHS is proposing a baseline year of 2014 for five of the measures and 2016 for one measure. All targets are to be achieved by 2020. HHS invites interested public and private professionals, organizations, and consumer representatives to submit written comments on the proposed 2020 ADE targets, found at https://health.gov/hcq/ade-measures.asp.

Federal Register, Volume 81 Issue 203 (Thursday, October 20, 2016)

[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72594-72595]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25424]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on the Proposed Measures and 2020 Targets 
for the National Action Plan for Adverse Drug Event Prevention: 
Inpatient and Outpatient Measures for Reduction of Adverse Drug Events 
From Anticoagulants, Diabetes Agents, and Opioid Analgesics

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 (ODPHP), 
on behalf of the U.S. Department of Health and Human Services (HHS) 
Federal Interagency Steering Committee for Adverse Drug Events, 
proposes new measures and targets for adverse drug events (ADEs) from 
anticoagulants, diabetes agents, and opioid analgesics for the National 
Action Plan for Adverse Drug Event Prevention (ADE Action Plan). Based 
on input from the Federal Interagency Workgroups for Adverse Drug 
Events, six national measures and targets for the reduction of ADEs are 
being proposed. Each drug class highlighted in the ADE Action Plan 
(anticoagulants, diabetes agents, and opioid analgesics) includes a 
proposed inpatient and outpatient measure to track national progress in 
reduction of ADEs from these drug classes. The proposed targets will 
reflect improvement efforts over a four to six year period since the 
release of the ADE Action Plan in August 2014. As such, HHS is 
proposing a baseline year of 2014 for five of the measures and 2016 for 
one measure. All targets are to be achieved by 2020. HHS invites 
interested public and private professionals, organizations, and 
consumer representatives to submit written comments on the proposed 
2020 ADE targets, found at https://health.gov/hcq/ade-measures.asp.

DATES: Comments on the proposed ADE 2020 measures and targets must be 
received no later than 5 p.m. on November 21, 2016.

ADDRESSES: Interested persons or organizations are invited to submit 
written comments by any of the following methods:
     Email: [email protected] (please indicate in the subject line: 
Proposed ADE Measures and Targets)
     Mail/Courier: Office of Disease Prevention and Health 
Promotion, Attn: Division of Health Care Quality, Department of Health 
and Human Services, 1101 Wootton Parkway, Suite LL100, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT: Anna Gribble, Health Policy Fellow, 
Office of Disease Prevention and Health Promotion, via email at 
[email protected].

SUPPLEMENTARY INFORMATION: In September 2012, in response to heightened 
awareness of the contribution of ADEs to the burden of health care-
related harm and costs, the Office of the Assistant Secretary for 
Health (OASH) marshaled the wide-ranging and diverse resources of 
federal partners to form an extensive interagency partnership, the 
Federal Interagency Steering Committee and Workgroups for Adverse Drug 
Events, whose goals would be to develop the ADE Action Plan, as well as 
identify measures to track national progress in reducing ADEs and 
targets to meet based on those measures.
    ODPHP, in conjunction with the Federal Interagency Steering 
Committee and three Federal Interagency Workgroups, developed and 
released the final ADE Action Plan in 2014. The ADE Action Plan seeks 
to engage all stakeholders in a coordinated, aligned, and multi-sector 
effort to reduce ADEs that are clinically significant, account for the 
greatest number of measurable harms as identified by existing 
surveillance systems, and are largely preventable; these were 
identified as ADEs resulting from inpatient and outpatient use of 
anticoagulants, diabetes agents, and opioid analgesics (with specific 
focus on ADEs from therapeutic use of opioids). The ADE Action Plan 
identifies the federal government's highest priority strategies and 
opportunities for advancement, which will have the greatest impact on 
reducing ADEs. Implementation of these strategies is expected to result 
in safer and higher quality health care services, reduced health care 
costs, informed and engaged consumers and ultimately, improved health 
outcomes. The reduction of ADEs subsequent to implementation of these 
strategies will be tracked by the proposed measures and will aim to 
meet the targeted reduction rate by 2020.
    The six proposed measures use data from the Agency for Healthcare 
Research and Quality (AHRQ), the Centers for Disease Control and 
Prevention (CDC), and the Food and Drug Administration (FDA). The 
inpatient and outpatient measures for anticoagulants and diabetes 
agents and the outpatient measure for opioids will set baseline rates 
using data from 2014 and establish targets to be achieved by 2020. The 
inpatient opioids measure will have a 2016 baseline and a 2020 target 
year. The inpatient opioids measure will use data from AHRQ's Quality 
Safety Review System (QSRS) which will begin collecting data in 2016. 
The inpatient measures for anticoagulants and diabetes agents will use 
AHRQ's Medicare Patient Monitoring System (MPSMS) for 2015

[[Page 72595]]

and QSRS for 2016-2020 and data will be adjusted accordingly. MPSMS did 
not include an opioids specific measure and QSRS now allows AHRQ to now 
track inpatient opioids adverse drug events.
    Descriptions of the surveillance systems, measures, and targets can 
be found here: https://health.gov/hcq/ade-measures.asp.
    Interested persons or organizations are invited to submit written 
comments in response to the proposed measures and targets. Written 
comments should not exceed more than two pages per ADE measure. The 
comments should reference the specific measure or target to which 
feedback refers. To be considered, the person or representative from an 
organization must self-identify and submit the written comments by 
close of business on November 21, 2016.

    Dated: September 30, 2016.
Don Wright,
Deputy Assistant Secretary for Health, Director, Office of Disease 
Prevention and Health Promotion Office of the Assistant Secretary for 
Health.
[FR Doc. 2016-25424 Filed 10-19-16; 8:45 am]
 BILLING CODE 4150-32-P

72594 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
Number of Total annual Hours per
FDA center frequency per Total hours
respondents responses response
response

CDRH ................................................................................... 2,465 1 2,465 137 337,705
CBER ................................................................................... 79 1 79 137 10,823

Total .............................................................................. ........................ ........................ ........................ ........................ 348,528
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Respondents are medical device a proposed inpatient and outpatient reducing ADEs and targets to meet
manufacturers subject to FDA’s laws measure to track national progress in based on those measures.
and regulations. FDA’s annual estimate reduction of ADEs from these drug ODPHP, in conjunction with the
of 2,544 submissions is based on classes. The proposed targets will reflect Federal Interagency Steering Committee
experienced trends over the past several improvement efforts over a four to six and three Federal Interagency
years. FDA’s administrative and year period since the release of the ADE Workgroups, developed and released
technical staffs, who are familiar with Action Plan in August 2014. As such, the final ADE Action Plan in 2014. The
the requirements for current Pre- HHS is proposing a baseline year of ADE Action Plan seeks to engage all
Submissions, estimate that an average of 2014 for five of the measures and 2016 stakeholders in a coordinated, aligned,
137 hours is required to prepare a Pre- for one measure. All targets are to be and multi-sector effort to reduce ADEs
Submission. achieved by 2020. HHS invites that are clinically significant, account
Dated: October 13, 2016. interested public and private for the greatest number of measurable
Leslie Kux,
professionals, organizations, and harms as identified by existing
consumer representatives to submit surveillance systems, and are largely
Associate Commissioner for Policy.
written comments on the proposed 2020 preventable; these were identified as
[FR Doc. 2016–25359 Filed 10–19–16; 8:45 am]
ADE targets, found at https://health.gov/ ADEs resulting from inpatient and
BILLING CODE 4164–01–P hcq/ade-measures.asp. outpatient use of anticoagulants,
DATES: Comments on the proposed ADE diabetes agents, and opioid analgesics
2020 measures and targets must be (with specific focus on ADEs from
DEPARTMENT OF HEALTH AND
received no later than 5 p.m. on therapeutic use of opioids). The ADE
HUMAN SERVICES
November 21, 2016. Action Plan identifies the federal
Request for Comments on the government’s highest priority strategies
ADDRESSES: Interested persons or and opportunities for advancement,
Proposed Measures and 2020 Targets organizations are invited to submit
for the National Action Plan for which will have the greatest impact on
written comments by any of the reducing ADEs. Implementation of these
Adverse Drug Event Prevention: following methods:
Inpatient and Outpatient Measures for strategies is expected to result in safer
Reduction of Adverse Drug Events • Email: OHQ@hhs.gov (please and higher quality health care services,
From Anticoagulants, Diabetes Agents, indicate in the subject line: Proposed reduced health care costs, informed and
and Opioid Analgesics ADE Measures and Targets) engaged consumers and ultimately,
• Mail/Courier: Office of Disease improved health outcomes. The
AGENCY: Office of Disease Prevention Prevention and Health Promotion, Attn: reduction of ADEs subsequent to
and Health Promotion, Office of the Division of Health Care Quality, implementation of these strategies will
Assistant Secretary for Health, Office of Department of Health and Human be tracked by the proposed measures
the Secretary, Department of Health and Services, 1101 Wootton Parkway, Suite and will aim to meet the targeted
Human Services. LL100, Rockville, MD 20852. reduction rate by 2020.
ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
The six proposed measures use data
Anna Gribble, Health Policy Fellow, from the Agency for Healthcare
SUMMARY: The Office of Disease Research and Quality (AHRQ), the
Office of Disease Prevention and Health
Prevention and Health Promotion Promotion, via email at anna.gribble@ Centers for Disease Control and
(ODPHP), on behalf of the U.S. hhs.gov. Prevention (CDC), and the Food and
Department of Health and Human Drug Administration (FDA). The
Services (HHS) Federal Interagency SUPPLEMENTARY INFORMATION: In inpatient and outpatient measures for
Steering Committee for Adverse Drug September 2012, in response to anticoagulants and diabetes agents and
Events, proposes new measures and heightened awareness of the the outpatient measure for opioids will
targets for adverse drug events (ADEs) contribution of ADEs to the burden of set baseline rates using data from 2014
from anticoagulants, diabetes agents, health care-related harm and costs, the and establish targets to be achieved by
and opioid analgesics for the National Office of the Assistant Secretary for 2020. The inpatient opioids measure
Action Plan for Adverse Drug Event Health (OASH) marshaled the wide- will have a 2016 baseline and a 2020
Prevention (ADE Action Plan). Based on ranging and diverse resources of federal target year. The inpatient opioids
mstockstill on DSK3G9T082PROD with NOTICES

input from the Federal Interagency partners to form an extensive measure will use data from AHRQ’s
Workgroups for Adverse Drug Events, interagency partnership, the Federal Quality Safety Review System (QSRS)
six national measures and targets for the Interagency Steering Committee and which will begin collecting data in
reduction of ADEs are being proposed. Workgroups for Adverse Drug Events, 2016. The inpatient measures for
Each drug class highlighted in the ADE whose goals would be to develop the anticoagulants and diabetes agents will
Action Plan (anticoagulants, diabetes ADE Action Plan, as well as identify use AHRQ’s Medicare Patient
agents, and opioid analgesics) includes measures to track national progress in Monitoring System (MPSMS) for 2015

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Document Created: 2016-10-21 09:59:27
Document Modified: 2016-10-21 09:59:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on the proposed ADE 2020 measures and targets must be received no later than 5 p.m. on November 21, 2016.
Contact		Anna Gribble, Health Policy Fellow, Office of Disease Prevention and Health Promotion, via email at [email protected]
FR Citation		81 FR 72594