registrant confidentiality was one of the primary considerations
in developing the system. An advisory panel
made up of representatives from patient groups, the FDA, and manufacturers helped design
the system to safeguard sensitive registrant information. To ensure
confidentiality, the Patient Notification System is operated
by Stericycle, Inc., an independent
organization that specializes in pharmaceutical notifications.
All registrant information will be held in strict confidence by Stericycle, Inc.
Free to Registrants
There is no fee to participate in the Patient Notification System. The system is funded by the manufacturers of plasma-derived and recombinant analog therapies and is free to all registrants.
Cooperative Effort Between Industry and Stakeholders
| Founding Partners:
These stakeholders worked closely with the plasma protein therapeutics industry in designing
the Patient Notification System in 1998.
- Alpha-1 Foundation
- Committee of Ten Thousand
- Hemophilia Federation of America
- Immune Deficiency Foundation
- National Hemophilia Foundation
The system is administered
by PPTA and is supported and funded by all major plasma-derived
and recombinant analog therapy manufacturers.
- Baxalta US Inc.
- Bayer Healthcare LLC
- Biogen Inc.
(now Bioverativ U.S., LLC)
- Biotest Pharmaceuticals Corporation
- Bioverativ U.S., LLC
- Cangene Corporation dba Emergent BioSolutions
- CSL Behring
- CSL Behring Canada
- Grifols USA Inc.
- Kedrion Biopharmaceuticals
- Novo Nordisk
- Octapharma USA Inc.
- Octapharma Canada Inc.
- Pfizer Inc.
An advisory panel made up of patient groups, the FDA, and industry representatives provides input
on the system and makes additional recommendations for future
How the System Works
|Anyone interested in participating registers with the Patient
Notification System and provides general contact information,
including their preferred method of notification. Registrants
have the opportunity of being notified by email, telephone, or fax,
whichever is most convenient for them. Please consider email as your
method of notification for the following reasons: instantaneous,
trackable, accessable, even on travel.
If a therapy is withdrawn or recalled, the company involved immediately
contacts Stericycle, Inc. which then directly notifies the registrant.
Every effort will be made to notify registrants within
24 hours. Each registrant will also receive a letter by first-class mail
to ensure receipt of the information.
In addition, consumers can go online to www.PatientNotificationSystem.org or call a 24-hour,
toll-free number 1-888-UPDATE-U (1-888-873-2838) for current information on
therapy recalls or withdrawals. To maximize the usefulness of the system, it is
important for consumers to keep accurate infusion logs and record the
lot number, therapy name, and manufacturer for all therapies used.
"The Patient Notification System is a model for cooperation and communication between industry and consumers."
Kimberly Haugstad, MBA
Hemophilia Federation of America
"The Patient Notification System was the first activity of a newly formed coalition of patient advocates. Alpha-1 is proud to have been a founding member of this group that worked with industry to ensure that patients received direct notification in the event of a product recall or withdrawal. It is good to know that 20 years later this system is still in place to notify patients directly."