2005D-0385 Guidance for Industry on Using Electronic Means to Distribute Certain Product Information
FDA Comment Number : EC8
Submitter : Mr. David Luce Date & Time: 12/05/2005 05:12:25
Organization : Mr. David Luce
Category : Drug Industry
Issue Areas/Comments
Using electronic means to distribute urgent safety information will save lives. The method chosen will make the difference in both effectiveness and the ability to measure results.

Using an open system method of email delivery, while convenient, is really not the best possible solution. From a hardware perspective, routers make no distintinction between packets whose message when combined can equally communicate pornography, viruses or life saving information. Server software many times can not detect SPAM versus trusted email and can either let unwanted email overwhelm inboxes or suppress needed communications. Open systems can also be more easily compromised with false information.

A closed system method with computer MAC addresses, computer names and individual users registered, as in a secure, healthcare professional registry, will provide the needed level of security to ensure and track the communication of life saving information.

As well, all healthcare professionals need to log into the site at the beginning of their shift to confirm receipt of each day?s content. Using this type of homepage, portal or dashboard approach will ensure measurable results.

In the future, all healthcare professionals could enter prescription information as part of treatment for diagnosed conditions. If CPOE (computer physician order entry) is available then all the better for patient, physician and tracking of public safety.

Special mention needs to be made on behalf of physicians that either do not have a computer, broadband access or the time or background to use this type of electronic solution and closed method. Traditional paper communications will need to continue provided every physician registers and indicates they do not have broadband Internet access in their area. And yes, lack of access should be confirmed.

For physicians that do not have the time due to the medical practice structure or underserved conditions, officers of the medical practice will need to provide a date when trained support staff can support physicians? needs. The clear message we need to send is that all medical practices will be responsible to confirming acknowledgement of life saving information - 100K adverse reactions resulting in death is why the proper use of technology will be our saving grace in preserving the good name of healthcare, clinical research and the public management of health.

Interruption of service needs to be handled from a business continuity, disaster recovery perspective. After a period of time, perhaps 6 hours, the medical practice will need to call or fax their status so that a contingency method can be used such as fax, telephone and postal service. There are any number of automated support methods that can bolster communication for any given crisis.

Lastly, we need to establish the healthcare user base as being more than just 800K MDs and 2000K RNs. Additional first responders and identified rural support staff also need to be registered.

Sure, it is easier to broadcast emails or use the NIH listserve method to somewhat qualify intended recipients. However, just imagine being able to track the communication confirmation and compliance rates with undisputed precision. A secure, closed system homepage or portal or dashboard with a healthcare registry is a clear and hopefully concise solution.

Feel free to contact me regarding any details. I think you will find agreement on the above suggestions from the technology, security as well as the emergency management communities. If there are dissenting opinions that either question the method or ability to support today, please let me know. Dialog and debate are healthy and necessary to yield the best results.

Best regards,
David Luce