Docket Management
Docket: 02N-0204 - Bar Code Label Requirements for Human Drug Products
Comment Number: EC -43

Accepted - Volume 13

Comment Record
Commentor Ms. Anne Paschall Date/Time 2003-04-29 17:10:56
Organization Ohio Department of Mental Health
Category Other

Comments for FDA General
1. General Comments Bar coding is a great idea except for small state mental hospitals, bar coding is going to be very expensive. Not only will the medications be more expensive because the manufacturers will pass that technology cost onto their customers, but having the wireless equipment that will be able to track the administration of the medication to the patient will be even more expensive. Also the packages will increase in size which means that we will have to stock our automated drug dispensing machines (ADMs)much more frequently or start carrying floor stock that is not controlled by the ADMs. Carrying more floor stock items would actually reduce patient safety and should be avoided. We have tried to implement wireless technology in several of our hospitals, and not one vendor's solution has been successful given the age of our buildings and their type of construction. We would love to implement this technology, but short of tearing down and rebuilding, we cannot. We are using bar coding for reordering medication so we do have the sophistication to implement this type of technology. However, we can batch enter that data. Drug distribution must be done interactively at the time of administration or it would be useless. I am concerned that by requiring this technology for all providers regardless of size that these providers will not be able to adapt and that they will lose their accreditation and care levels will drop or they will not staff appropriately in order to cover the costs. However, as the technology improves and becomes less expensive, this approach should be definitely encouraged but not mandated. I am the Chief Information Officer for the Integrated Behavioral Healthcare System, Ohio Department of Mental Health and am responsible for the computerized physician order entry ststem, Pharmacy system and automated drug machine interface as well as all other clinical, billing and operationally supportive systems. I regularly 0travel around the country and am familiar with what other hospitals are doing, and most hospitals would find this requirement to be difficult to conform too especially if you start adding more than the NDC # to the coding. Thank you for considering my comments.

EC -43