Only 30% of the bleeding disorders community is registered for the Patient Notification System (PNS).
Recalls and withdrawals for medical products and the associated ancillary supplies do occur.
When a recall or withdrawal is announced, each manufacturer and supplier has their own internal process for notifying pharmacies, clinicians, and patients. However, for patients with bleeding disorders, there is another resource that will alert you directly in the event of a product recall or withdrawal: the Patient Notification System (PNS).
HFA believes the PNS is a valuable resource for patients and families with bleeding disorders.
What is PNS?
PNS is a fast, free, and confidential program that alerts patients with hemophilia, von Willebrand Disease, and other bleeding disorders of a withdrawal or recall of therapy products. All major plasma-derived and recombinant analog therapy manufacturers participate in this system.
If a therapy is withdrawn or recalled, the system notifies those registered for the therapy in question within 24 hours. Patients can choose to be contacted via email, telephone, or fax, and are also sent a letter via first-class mail to ensure receipt of the notice.
Why Should I Register?
Whether you use plasma-derived or recombinant therapies, there are many reasons that your therapy might be recalled.
Past recalls and withdrawals include:
- Defective sterile water vials
- Improperly packaged alcohol wipes
- Problems with the product potency and shelf life
- Mislabeled products
- Factor contamination
- And many more.
How to Register
Patients, caregivers, parents, and spouses can register at the PNS website.
Any provider, such as clinicians, pharmacies, and others who provide services and care to people in the bleeding disorders community can also register for the PNS.
The Plasma Protein Therapeutics Association (PPTA) leads the PNS. PPTA contracts with Stericycle Inc. a firm who specializes in these types of pharmaceutical notifications for their expertise and in recognition of the concerns for patient privacy. All registrant information will be held in strict confidence by Stericycle, Inc.
It is the responsibility of the registrant to ensure that their contact and medical information is up to date in the system. If a patient begins taking a new therapy, or moves, changes their email address, or their phone number, they will need to amend this information with the system.
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
Withdrawals are a firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA, or which involves no violation.
- For more information on FDA recalls or withdrawals for biologic products, click here.
- For more information on FDA recalls or withdrawals for other drugs, click here.
Recalls and withdrawals of clotting factor therapies are also listed on the PNS website, and at their toll-free number (1888-UPDATE-U).