[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43206-43208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17295]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-13-13ZZ]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570
and send comments to LeRoy Richardson, 1600 Clifton Road, MS-D74,
Atlanta, GA 30333 or send an email to [email protected].
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Evaluation of the SAMHSA PDMP Electronic Health Record (EHR)
Integration and Interoperability Expansion Program--New--National
Center for Injury Prevention and Control (NCIPC), Center for Disease
Control and Prevention (CDC).
[[Page 43207]]
Background and Brief Description
In 2009, drug overdose deaths became the leading cause of injury
death in the United States (U.S.), exceeding motor vehicle traffic
crash deaths for the first time, a trend that continued in 2010.
Prescription drugs, particularly opioid pain relievers, have been
identified as the main driver of this increase. The number of overdose
deaths per year involving opioid pain relievers increased more than
four-fold from 1999 to 2010 (from 4,030 to 16,651), outnumbering
overdose deaths involving all illicit drugs combined. Morbidity
associated with opioid pain reliever abuse increased in parallel. The
rate of emergency department visits associated with the misuse or abuse
use of opioid pain relievers increased 153% from 2004 to 2011, while
rates for illicit drugs remained largely stable.
Concurrent to this rise in overdose death rates, the sales of
opioid pain relievers have increased four-fold since 1999. According to
the National Survey of Drug Use and Health, the primary source of
prescription drugs for non-medical use is from prescribed and dispensed
prescriptions; more than 70% of those who reported non-medical use of
pain relievers said they obtained the pain reliever they most recently
used from a friend or relative. Moreover, multiple studies have found
an association between increased opioid prescribing--in the amount
prescribed per prescription, the total days' supply, and the number of
prescriptions per patient--and increased morbidity and mortality in the
U.S. over the last 10 to 15 years.
Prescription Drug Monitoring Programs (PDMPs) are now recognized as
a key tool in federal, state, and local efforts to address prescription
drug abuse and misuse. PDMPs are state databases to which pharmacies
and other dispensers report dispensed outpatient controlled substance
prescription information. Forty-nine states have passed legislation
authorizing a PDMP, and 45 states currently have an operational
program. In the vast majority of these programs, prescribers and
pharmacists (herein referred to collectively as providers) can register
to become an authorized user of the PDMP. Following authorization,
users can then conduct online queries to obtain prescription histories
for their patients, a process that may take up to several minutes. For
many providers, accessing patient prescription histories offers
critical input that can inform their clinical decision-making. This
process has shown promise in preventing prescribing to patients who
appear to be abusing prescription medications or obtaining controlled
substances prescribed by multiple providers without knowledge of the
other prescriptions (referred as doctor shopping) while enabling
appropriate prescribing and dispensing for legitimate patients,
especially for pain medication.
However, for many providers, even the few minutes required to log
on to the PDMP and query a patient's prescription history present a
barrier to regular use. Moreover, gaps in patients' prescription
histories due to limited interstate sharing of PDMP data has
contributed to relatively slow rates of provider registration with and
use of PDMPs. PDMP reports show that it often takes four or more years
following the implementation of online PDMP access for registration in
the state to reach 50% of the prescribers who write controlled
substance prescriptions, thus limiting the potential impact of these
programs. Various strategies have been proposed to increase provider
use of PDMPs. For example, several states have recently passed
legislation mandating provider registration with and use of the PDMP
under certain circumstances. Many states have also initiated efforts to
enroll providers in educational training programs on the value of using
PDMP data to counteract the prescription drug overdose epidemic. The
project described below takes a different approach to increasing
provider use of PDMPs.
In an effort to increase provider utilization of PDMPs and to
effectively reduce prescription drug abuse and overdose, the Substance
Abuse and Mental Health Services Administration (SAMHSA) funded
projects in nine states beginning in fiscal year (FY) 2012 and lasting
for a period of two years through its PDMP Electronic Health Records
(EHRs) Integration and Interoperability Expansion (PEHRIIE) cooperative
agreement program. The goals of this program are to:
(1) Increase provider utilization of their state's PDMP by
improving real-time access to PDMPs via the integration of PDMP data
and/or access thereof within health information technologies (HIT) such
as health information exchanges (HIEs), EHR systems, and/or pharmacy
dispensing software (PDS). Ultimately, when providers access a
patient's EHR, s/he will have automatic access to that patient's up-to-
date prescription history within the course of their normal clinical
workflow, thereby obviating the time and effort otherwise needed to
access the PDMP and obtain this information separately from the
patient's medical record. Similarly, when a pharmacist calls up patient
information via the PDS, the patient's prescription history from the
PDMP will be automatically compiled, allowing for expedited access and
review prior to dispensing.
(2) Increase provider utilization of PDMP data by increasing the
comprehensiveness and quality of PDMP data by increasing the
interoperability of PDMPs across state lines. When providers access a
patient's prescription history from his or her state PDMP (either
directly or via the systems described above), data from other state
PDMPs with which the home state PDMP is interoperable will be
automatically included. By providing a more complete prescription
history, PDMP data is expected to have greater utility in clinical
decision-making, thus offering an inducement for providers to access
and utilize PDMP data more frequently.
Both of these goals are expected to contribute to improving
prescribing and dispensing practices, resulting in decreased
prescription drug abuse and misuse and related health consequences such
as fatal and non-fatal overdoses as well as lead to improvements in
care.
Under the cooperative agreements issued by SAMHSA, the CDC is
responsible for conducting a comprehensive process and outcomes
evaluation of the PEHRIIE program. The evaluation team consists of
health scientists on the Prescription Drug Overdose team within the
Division of Unintentional Injury Prevention, National Center for Injury
Control and Prevention at CDC, and two subject matter experts at the
PDMP Center of Excellence at Brandeis University. The primary goals of
the qualitative evaluation component of this work are:
(1) To understand the processes, challenges, and successes in
implementing and sustaining integration of PDMP data with Health
Information Technology (HIT) systems and interoperability of PDMP
systems across states; and
(2) To understand the experiences of clinical end users with the
systems being upgraded under the PEHRIIE program and to capture their
recommendations, if any, for how the goals of the PEHRIIE could have
been better accomplished.
To achieve these evaluation goals, the CDC evaluation team will
conduct qualitative interviews with those individuals involved in the
planning and implementation of the PEHRIIE projects (i.e., key project
staff and stakeholders) as well as with the clinical end users (i.e.,
prescribers and
[[Page 43208]]
pharmacists) of the PDMPs in the states where these projects are taking
place.
This evaluation is consistent with CDC's strategic goals of
improving surveillance, informing policy, and improving clinical
practice. CDC believes that the most effective interventions in
combating the prescription drug overdose epidemic include those
designed to identify and address high-risk patients at a stage when
their risky behaviors can be most effectively addressed. Strong yet
accessible PDMPs that promote proactive patient interventions are a
critical component of this high-risk focused strategy. By enabling
providers to identify high-risk patients at the point of care, via
improved access to and use of PDMPs and improved comprehensiveness of
PDMP data, providers can intervene with patients and address their
high-risk behaviors, including providing or redirecting patients to
substance abuse treatment as necessary. Through this evaluation, CDC
will better understand the impact of PDMP integration and
interoperability in the funded states.
The total annual estimated burden hours for the planned qualitative
information collection are 235 hours. Total burden time includes the
time to conduct interviews with key project staff/stakeholders and
clinical end users, and the time spent by recruiters at the PEHRIIE
implementation sites to identify potential clinical end user
interviewees.
It will take 79 hours of interviewee time to complete all of the
key project staff/stakeholder interviews necessary for the planned
evaluation of the PEHRIIE program. Interviews will be conducted with 91
key project staff members/stakeholders across the nine PEHRIIE-funded
states (range: 6-16 interviews per state) as well as 14 key project
staff/stakeholders representing five companies working with multiples
states involved in the PEHRIIE program, for a total of 105 key project
staff/stakeholders interviewees. Based on pilot testing with three
individuals, each key project staff/stakeholder interview will take
approximately 45 minutes to complete. Therefore, 105 key project staff/
stakeholder interviews at 45 minutes each will require 79 hours of
interviewee time.
It will take 117 hours of interviewee time to complete all of the
clinical end user interviews necessary for the planned evaluation of
the PEHRIIE program. Each interviewee will be interviewed once. End
user interviews will be conducted at 39 implementation sites
distributed across all nine PEHRIIE states (range: 3-8 sites per
state). Interviews will be conducted with three clinical end users per
implementation site for a total of 117 clinical end user interviews.
Based on pilot testing with three individuals, each clinical end user
interview will take one hour to complete. Therefore, 117 clinical end
users at 1 hour each will require 117 hours of interviewee time.
It will take 39 hours of recruiter time to identify potential
clinical end user interviewees, to collect the contact information from
these clinical end users, and to disseminate this collected information
to the CDC evaluation time. The CDC will work with one recruiter per
implementation site to complete these tasks. Based on the time required
to complete similar tasks during the planning of the clinical end user
pilot interviews, each recruiter is expected to spend approximately one
hour on these tasks. Therefore, 39 recruiters spending one hour each on
this information collection will require 39 hours of recruiter time.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs) (in hrs)
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Key Project Staff/Stakeholders Key Project 105 1 45/60 79
Staff/
Stakeholders
Interview Guide.
Clinical End Users............ Clinical End 117 1 1 117
Users Interview
Guide.
Clinical End User Recruiters.. N/A............. 39 1 1 39
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Total..................... ................ .............. .............. .............. 235
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2013-17295 Filed 7-18-13; 8:45 am]
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