[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29773-29775]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12629]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Call for Participation in Pillbox Patient-Safety Initiative
ACTION: Notice.
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SUMMARY: The National Library of Medicine (NLM) invites the
participation of manufacturers, including repackagers, and private
label distributors of solid oral dosage form medications in the
development of Pillbox, a publicly accessible online repository of
digital images and descriptive information for solid oral dosage form
medications. This project seeks to promote utilization of the SPLIMAGE
element of the Food and Drug Administration (FDA) Structured Product
Label (SPL) through development and use of imaging standards and
methodologies. Through this Call for Participation, NLM seeks to
evaluate the photography methodology and procedures it has developed
for creating standardized high-resolution images of solid oral dosage
form medications that are appropriate for inclusion in the SPL.
Participating organizations will be invited to submit samples of their
solid oral dosage form medications to NLM for imaging. Resulting image
files will be provided to participants, who may choose to voluntarily
include them in their subsequent SPL submissions to FDA. Image files
that are voluntarily submitted to FDA as part of an SPL listing
submission will be included in the publicly accessible, production
version of Pillbox. This initiative is an important element of ongoing
efforts to enhance patient safety, reduce adverse drug events, and
improve the quality and availability of drug information.
SUPPLEMENTARY INFORMATION: NLM has established Pillbox, an initiative
to enhance patient safety, by making available via a publicly
accessible resource (http://pillbox.nlm.nih.gov) digital images and
descriptive data of
[[Page 29774]]
solid oral dosage form medications (e.g., capsules and tablets, also
referred to as ``pills''). NLM intends to create a search system
allowing patients, healthcare providers, and the public to identify and
reference medications using the submitted images and related
descriptive information. Such a resource is intended to have
application in poison control, emergency response, disaster response,
anti-counterfeiting, manufacturer compliance with Federal regulations,
improved prescription filling accuracy, and reduction of medication
errors and adverse drug events.
Images of tablets and capsules that are currently available to the
public from various online resources are of varying quality. There
exists no single, authoritative resource of high-quality images
representative of prescription and non-prescription medications
available in the United States from which a trustworthy resource such
as Pillbox can be constructed. To remedy this situation, NLM, working
with FDA, has developed a standardized methodology for creating digital
images of solid oral dosage form medications. Presently, NLM is testing
a demonstration/beta version of Pillbox that contains SPL information
for listed solid oral dosage form medications and NLM-produced images
for approximately 1,000 solid oral dosage form medications. Because
these images are not part of the SPL and have not been verified by the
manufacturer; the demonstration/beta version of Pillbox contains a
disclaimer indicating that it is a demonstration system that is not
intended for clinical use.
In order to test the imaging methodology in an operational setting
and to begin developing a production version of Pillbox, NLM is
offering, on a time-limited basis, to provide manufacturers, including
repackagers, and private label distributors who send product samples to
NLM, image files suitable for inclusion with their SPL files that are
being submitted to FDA. Manufacturers, including repackagers, and
private label distributors may voluntarily include this standardized
image in the SPL file they submit to FDA as part of the drug listing
process. If a firm includes the image with an SPL submission, that
image will be included in the production version of Pillbox. The
production version of Pillbox will only contain images that have been
verified by manufactures, including repackagers, and private label
distributers. When the production version of Pillbox is launched, the
current demonstration/beta version will be taken offline from public
access and will only be used for agency research and development. NLM
may also use the images it produces to populate the offline version of
Pillbox to further agency research and development.
Photography Facility
NLM, in collaboration with FDA, has set up a photography laboratory
at an FDA facility in Rockville, Maryland for the purpose of generating
standardized images of representative solid oral dosage form
medications for the duration of this project. This facility is
registered with the Drug Enforcement Administration.
NLM will provide to manufacturers, including repackagers, and
private label distributors, at no cost, an image suitable for
submission to FDA as part of drug listing for any actively marketed
solid oral dosage form medication that is sent to them. The image will
encompass visible spectrum only. Ultra-violet and infrared images will
not be captured.
No physical or chemical tests or assays of any nature will be
performed on the submitted products. Once imaging is completed, the
representative solid oral dosage form medications will be destroyed.
Photographs will be provided for the duration of the testing
period, which is anticipated to continue through FY2012. The agency
will provide information about further development of Pillbox, the
production of SPL image files, and the standardized methodology for SPL
images after completion of the testing period.
Participation
We invite manufacturers, including repackagers, and private label
distributors of solid oral dosage form medications to voluntarily
participate in this program.
Procedure for Submitting Applicable Packaged Products for Imaging
Manufacturers, including repackagers, and private label
distributors of prescription and over-the-counter solid oral dosage
form medications may submit products for imaging. The expiration date
on the submitted products' packaging should be the longest available
expiration date. Participants should:
1. Indicate to the agency their intent to participate in this
program via e-mail to pillbox@mail.nih.gov. It is not necessary to
provide any information related to products which will be submitted in
this announcement of intent. This initial communication is strictly to
express intent and to allow for resource allocation planning.
2. Select and ship the smallest volume stock package(s) totaling at
least 8-10 representative solid oral dosage form medications (e.g.,
tablets, capsules) of the same drug product. In order to ensure the
safety of facility staff and compliance with appropriate federal
regulations please include the accompanying prescribing information.
a. Consolidated shipments of multiple packages are permitted.
b. If there is an undue financial burden associated with providing
the smallest volume stock package, please contact NLM via e-mail to
pillbox@mail.nih.gov.
3. Provide contact information for the person(s) submitting the
solid oral dosage form medications and receiving the final images.
Contact information should include:
a. Firm's name and address.
b. Name, e-mail address, and telephone number of the person
submitting the representative solid oral dosage form medications.
c. Name, e-mail address, and telephone number of the person who is
responsible for receiving the final images of the representative solid
oral dosage form medications.
4. Send the representative solid oral dosage form medications to:
a. NLM PILLBOX IMAGING PROJECT, Attn: Staff Pharmacist, 2094
Gaither Rd., Suite 240, Room 245, Rockville, MD 20850.
The final image file will be sent to the specified e-mail address
of the person who is responsible for receiving the final image. The
manufacturer, repackager, or private label distributor may voluntarily
include the provided image in an SPL drug listing submission to FDA, in
the SPLIMAGE data element. Images submitted as part of the SPL will be
included in the production version of Pillbox.
Partnership Acknowledgment
Manufacturers, including repackagers, and private label
distributors who participate in this process will be acknowledged on
the Pillbox Web site and in other communications about the project.
FOR FURTHER INFORMATION CONTACT: Any question regarding this process or
the Pillbox initiative, including alternative methods for receiving the
images, should be sent to pillbox@mail.nih.gov. Any questions regarding
submission of the file to FDA should be sent to spl@fda.hhs.gov.
[[Page 29775]]
Dated: May 16, 2011.
Todd Danielson,
Executive Officer, National Library of Medicine, National Institutes of
Health.
[FR Doc. 2011-12629 Filed 5-20-11; 8:45 am]
BILLING CODE 4140-01-P