|
||
|
Frequently Asked Questions Is your question not answered in this FAQ? Please send questions to pillbox@mail.nih.gov to be added to the list. Why is Pillbox currently not intended for clinical use? The National Library of Medicine (NLM) has made substantial efforts to accurately connect each image to the appropriate medication. However, the images contained within Pillbox are not part of the Food and Drug Administration-approved Structured Product Label (SPL) (drug label) and have not been verified by each manufacturer. In fall 2009, the NLM and FDA will initiate a pilot program to begin large-scale photography of prescription solid dosage medications, working with manufacturers to have these images submitted for inclusion with the drug label. Once the images in Pillbox have been verified by manufacuturers this warning will be removed. Where are the rest of the pictures? As of September 2010 Pillbox contains 10,562 records. Of those, 912 currently have images. The National Library of Medicine, in collaboration with the Food and Drug Administration, has set up a photography laboratory in Rockville, Maryland for the purpose of generating standardized images of representative solid oral dosage forms. This project is ongoing and will continue to add new images to Pillbox. Why do the colors/shapes I select sometimes not match the pills which are displayed? When color and shape values are entered into the drug label, every effort is made to best match the sample to the selected value. However, this is a subjective decision and thus can create what appear to be inconsistent results when viewing large numbers of pills. Is there a way to standardize the color and shape values? One of the long-term goals of Pillbox is the development of software which creates a unique profile for each image, based on standardized values. While this information will not be a component of the drug label, it may be used to help users more easily identify an unknown pill. Will Pillbox ever allow searching on multiple colors on the same pill? Yes, that feature is currently in development and will be part of a future version of Pillbox. Are the imprint, shape, color, size, and score values in Pillbox 100% accurate? While every effort is made to validate and ensure accuracy, errors may be present. The NLM is working closely with the FDA and manufacturers to identify erroneous values and quickly correct them. If you see a value that appears to not be correct, please send that information to pillbox@mail.nih.gov. What is score? Score is a value which represents the number of equal-sized pieces a pill could be broken into, if it were split using the score lines present on the pill. For example, a round pill with a single score line would be broken into two equal-sized pieces; therefore it has a score value of 2. A square with two score lines in a cross pattern would be broken into four equal-sized pieces; therefore it has a score value of 4. A pill with no score lines has a value of 1. Try searching for the different score values in Pillbox to see examples. The FDA sets the official guidance for score. Where can I learn more about the specifications for the FDA's Structured Product Labeling (SPL) criteria? Structured Product Labeling Resources Imprint Shape Color Size Score |
||