[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

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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