Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. William Churchill Date/Time 2002-07-12 13:14:18
Organization Brigham and Women's Hospital
Category Health Professional

Comments for FDA General
1. General Comments I am in support of the FDA's proposal to promlogate regulations that will require pharmaceutical manufacturers to provide bar code labelling on of their products. We have checked all of the proiducts that we use at Brigahm and Women's Hospital and find that only 50% of our products are br coded at the unit of use product. This means when we implement or bar code scanning program next year we will need to repackage approximately 2.5 million doses. This is clearly unacceptable and needs to be done at the manufacturer level. My suggests are as follows: Bar codes should be 2 dimensional and include the NDC number, lot number and expiration date of the products. This will help to improve in identifying patients that received drugs or blood products they may have been recalled. It can also help us to chekc expiration dating of the drugs. The format for the bar code should be a univeral standardized format. As things stand now drug manufacturers that do bar code their products are using several different formats which makes it difficult to read this in a standard way. Some consideration should be given to RSS symbology and use of stacked bar codes. This is a critical step that healthcare institutions need to know which format is selected as early as possible so we can purchase the correct scanners. Manufacturers should be prohibited from pulling products from the market that are currently available in unit dose packaging because they do not want to go to the additional expense to comply with the bar codeing requirements. This would be counter to our efforts in healthcare for improving patient safety. Bar codes on medical devises would also be beneficial. A case in point that Iv pumps or individual channels on multi channel pumps should have a bar code. That way a nurse could scan the pump or device and have that info logged into the patient's record so that we could follow-up much more easilyn on device filures and malfunctions. We are in support of this proposal as well. Thank you for the opportunity to comment. William W. Churchill MS, R.Ph. Director of Pharmacy Services Brigham and Women's Hsopital Boston, Ma

EC -2