[Federal Register: May 23, 2007 (Volume 72, Number 99)]
[Notices]
[Page 28976-28977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my07-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Food and Drug Administration
[Docket No. 2007N-0179]
Implementation of Risk Minimization Action Plans (RiskMAPs) to
Support Quality Use of Pharmaceuticals: Opportunities and Challenges;
Public Workshop
AGENCIES: Agency for Healthcare Research and Quality; Food and Drug
Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) and the
Food and Drug Administration (FDA) are announcing a 2-day joint public
workshop entitled ``Implementation of Risk Minimization Action Plans
(RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and
Challenges.'' This public workshop is intended to seek constructive
input from a wide range of stakeholders, including clinicians,
pharmacists, patients, third party payers of care, the pharmaceutical
and biotechnology industries, researchers, and innovators in health
information technology (HIT), to help in the development and
implementation of mechanisms to minimize the risks of pharmaceuticals
with unusual safety and patient monitoring concerns. This meeting is an
initial step that is part of FDA's commitment to monitor the
performance of RiskMAPs consistent with the goal articulated in the
proposed PDUFA IV agreement to undertake regular follow up of these
plans.
DATES: The public workshop will be held on June 25 and 26, 2007, from
8:30 a.m. to 5 p.m. See section III of this document for information on
deadline and on how to register to attend or present at the meeting.
We are opening a docket to receive your written or electronic
comments. Written or electronic comments must be submitted to the
docket by July 31, 2007.
ADDRESSES: The public workshop will be held at the Agency for
Healthcare Research and Quality (AHRQ), 540 Gaither Rd., John M.
Eisenberg Bldg., Rockville, MD 20850. Submit electronic comments to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.
Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. All comments should be identified with
the docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Lee Lemley, Center for Drug Evaluation
and Research, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-5392, FAX: 301-827-4312, e-mail:
Coralee.Lemley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Risk minimization action plans (RiskMAPs) are safety programs
designed to minimize significant risks of a product by using one or
more risk minimization tools. A variety of risk minimization tools have
been used; these tools are broadly categorized as follows: (1)
Education and outreach tools intended to inform patients and healthcare
practitioners (HCPs) about a product's risks and measures that should
be taken to prevent or mitigate the risks; (2) Reminder systems
intended to prompt or guide HCPs and/or patients in prescribing,
dispensing, or
[[Page 28977]]
using a product in ways that minimize risk; and (3) performance-linked
access (PLA) systems that link product access to required laboratory
testing or other documentation. The latter two categories have
exhibited some success in minimizing risk, but may lead to disruptions
in medical and pharmacy practice and unintended consequences, such as
obstructing patient access to a product's benefits. It is the latter
two tool categories (Reminder and PLA systems) that are the primary
focus of this workshop. The following are a few of the products with
Reminder or PLA systems: Isotretinoin (iPLEDGE), Thalidomide (STEPS),
and Tysabri (TOUCH).
The workshop objectives are as follows: (1) Initiate constructive
dialogue and information-sharing among regulators, researchers, and
organizations and individuals affected by RiskMAP programs,
particularly those using Reminder and PLA systems; (2) share key
lessons learned about how to design and implement effective risk
management systems to accommodate and promote quality healthcare and
pharmacy practices; and (3) explore how tools being actively developed
(such as electronic prescribing and integrated electronic health and
medical records) and used to support high-quality, evidence-based
practice may improve the development of RiskMAPs where Reminder and PLA
systems are used or being considered for use.
Panel discussions as well as stakeholder presentations and
testimony will focus on implementation strategies using Reminder and
PLA systems to promote appropriate behavior changes to optimize patient
outcomes, autonomy, access, cost, and logistics while reducing drug
risks. We invite presentations that suggest ways to mitigate drug
safety risks by improving healthcare system processes or emerging
health information technologies. Examples might include linkages of
electronic prescribing to laboratory or to patient electronic health
records designed to improve the effectiveness of risk minimization
efforts.
AHRQ and FDA are working together to refine the conference agenda
and invite speakers. The agenda will be made available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/meeting/riskMAPs.htm
not later than June 15, 2007. We
are seeking broad participation by physicians, pharmacists, patients,
health care quality and safety researchers, health systems officials,
and payers of care. We anticipate issuing a summary of the conference
findings, including a discussion of implications and next steps for
further research or regulatory guidance development.
II. Comments
The agency is interested in hearing comments at the public workshop
or receiving written comments (see ADDRESSES) on the following issues:
(1) Based on the diversity of experiences of different groups in
implementing existing Reminder and PLA system RiskMAPs, what lessons
have been learned that can be applied to future programs in the
following areas:
Minimizing risks;
Maintaining provider and patient access to therapeutic
choices;
Minimizing burdens on the healthcare system;
Being compatible with diverse technologies and settings of
care;
Avoiding adverse unintended consequences.
(2) How can healthcare information technology be used to assist
quality prescribing, dispensing, and patient use to improve the
effectiveness of RiskMAPs for drugs with risks where Reminder and PLA
systems are used or likely to be used? How might HIT solutions be
pursued and applied in light of the underdeveloped use of this
technology in healthcare?
(3) How might professional organizations, third party payers of
care, and others support the appropriate use of medications with
processes or requirements such as those used with Reminder and PLA
system RiskMAPs?
(4) Who are the relevant stakeholders in healthcare to involve in
the design and choice of risk minimization tools? How can these
stakeholders be best engaged in meaningful and productive partnerships
and collaborations?
(5) Which activities and research should be pursued to develop a
strong evidence base of healthcare system approaches, processes, and
tools that support appropriate use of medications with safety problems
where Reminder and PLA RiskMAPs are being used or considered for use?
(6) What partnerships will support evaluations of effectiveness of
RiskMAPs or pilot interventions to minimize risk and promote
appropriate medication prescribing, dispensing, and use?
(7) What future actions should AHRQ and FDA take to promote
continued collaborations and contributions to the high-quality,
appropriate use of medications with RiskMAPs?
III. Registration
The AHRQ Conference Center is a Federal facility with limited
seating and security procedures for entrance. For these reasons, pre-
registration is necessary for all attendees. Registration is available
on a first-come basis. Individuals who wish to speak during the open
public hearing must register on or before June 8, 2007; all other
attendees must register on or before June 15, 2007. To register,
contact register@consolidatedsafety.com or call 703-877-3345.
Ample time will be allowed during the scheduled agenda for
attendees to ask questions of panelists. In addition, we strongly
encourage written comments to the docket.
If you need special accommodations because of disability, please
contact Lee Lemley (see CONTACT FOR FURTHER INFORMATION) at least 7
days before the workshop.
IV. Workshop Transcripts
The workshop will be transcribed. The transcript will be available
for review at the Division of Dockets Management (see ADDRESSES) and on
the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets approximately 30 days
after the workshop.
Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
Dated: May 16, 2007.
Carolyn Clancy,
Director, Agency for Healthcare Research and Quality, Department of
Health and Human Services.
[FR Doc. 07-2574 Filed 5-22-07; 8:45 am]
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