2011-12629. Call for Participation in Pillbox Patient-Safety Initiative

ACTION:

Notice.

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 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 [e-mail]. 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 [e-mail].

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 [e-mail]. Any questions regarding submission of the file to FDA should be sent to [e-mail].

Dated: May 16, 2011.

Todd Danielson,

Executive Officer, National Library of Medicine, National Institutes of Health.