In this day of very safe products, it might be tempting for some to let complacency take over and either not think about product safety at all, or mentally chalk it up as “someone else’s responsibility.” However, products are only safe today because consumers demanded it, and it remains everyone’s responsibility to ensure that blood and products remain safe.
One crucial step that anyone with a bleeding disorder can take is to register for the Universal Data Collection (UDC) project (UDC) of the Centers for Disease Control and Prevention. The UDC collects and monitors important patient data, including information on blood-borne pathogens and joint complications. It is one of the best indicators we have that current products are safe from viral pathogens, and will be an important warning system if a problem emerges in the future. You can learn more about the UDC from the CDC’s Web site. To participate in the UDC, talk to the staff at your local hemophilia treatment center (HTC).
Another basic thing everyone can do, is to register for the Patient Notification System (PNS). PNS was established by the Plasma Protein Therapeutics Association (PPTA), an industry trade group representing manufacturers of plasma-derived therapies and their recombinant analogs, in cooperation with patient organizations that serve on an advisory panel. The system allows any user of these therapies, or any interested party, to sign up for alerts notifying them when a product is either withdrawn or recalled because of a safety concern or other issue. Participants may receive notifications by e-mail, telephone or fax, and they also receive a copy of the notification by first class mail.
Some discussions have taken place about the possibility of adding other notification methods, such as text to phone or PDA. Although PNS is under the auspices of industry, it is operated by an outside contractor and no personal information from those who register is ever shared with PPTA or any of the manufacturers. Patient groups such as NHF and our chapters often redistribute notifications via other means including medical advisories, NHF eNotes and our Web site. However, the best way to insure that you get timely information about a product withdrawal or recall is to register for PNS or call 1.888.873.2838.
While PNS lets you know if there is an actual product withdrawal or recall, it does not provide other types of information about blood safety issues. However, much of this type of information can be found through NHF’ s communication vehicles, our chapters and other community organizations. For example, on NHF’s Web site, visitors can find information on a variety of blood-borne pathogens such as HIV, hepatitis C, West Nile Virus, variant Creutzfeldt-Jakob disease (vCJD) and others, including their potential impact on blood and product safety. Community organizations like the Committee of Ten Thousand (COTT) and the Hemophilia Federation of America (HFA) also discuss blood safety issues on their Web sites. Information about these issues is also available on the Web sites of government agencies that share in the responsibility of ensuring the safety of the nation’s blood supply. For example, a lot of information is available on the Web site of the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA.) Additional information can also be found at the Web site of the U.S. Department of Health and Human Services’ (HHS) Advisory Committee on Blood Safety and Availability (ACBSA). Some very good information is also available on the Web site of the World Federation of Hemophilia.
This article was excerpted from the Fall 2008 issue of Blood & Product Safety News, a new quarterly newsletter published by the National Hemophilia Foundation. It will be distributed via e-mail later this month.