Update on Hematologic Drug Shortages
Important Information Regarding Release of Daunorubicin
Over the past few months, ASH members have reported difficulty in obtaining Daunorubicin hydrochloride solution for injection and in several regions members report that the shortage is significantly impacting clinical trials. The FDA recently announced that limited quantities of Daunorbucin are now available; Bedford Laboratories has limited quantities available of Daunorubicin 5 mg/mL in 4 mL and 10 mL single-dose vials (NDC 55390-0108-10, and NDC 55390-0108-01), and 20 mg cerubidine lyophilized powder for injection (NDC 55390-0281-10). Teva Pharmaceuticals has Daunorubicin 5 mg/mL 4 mL vials (NDC 00703-5233-13) available but the company is reviewing orders prior to release and the product is available through drop shipment only. Pharmacies can order this NDC code from their wholesalers through the drop shipment process. Read more information about the supply of Daunorubicin, ASH's recent statement on FDA action to alleviate drug shortages, and updates on the status of additional hematologic drug shortages, ASH advocacy efforts, and resources for physicians dealing with shortages.
News from Washington
ASH Submits Comments to CMS Re: Proposed Rule on Transparency Reports and Reporting of Physician Ownership or Investment Interests
ASH submitted comments to the Centers for Medicare and Medicaid Services (CMS) urging modifications to the proposed rule, concerning transparency reports and reporting of physician ownership or investment interests. The proposed rule would implement the Physician Payments Sunshine Act ("Sunshine Act"). The Sunshine Act was incorporated into the Patient Protection and Affordable Care Act of 2010, and mandates disclosure of physicians' financial relationships with drug and device manufacturers. Though ASH supports the proposed rule's goal of discouraging inappropriate influence on clinical decision-making by increasing transparency, ASH recommendations focus on reducing the scope of the rule and reducing regulatory burdens on physicians. Specific recommendations included: stating that attending an industry supported educational session is not reportable; excluding from reporting certified CME; stating reprints of peer-reviewed articles intended for physician education meet the educational materials reporting exemption; and delaying reporting until a final rule has been issued. In addition, ASH has signed-on to a letter sent to CMS by a coalition of medical societies concerned that the proposed rule exceeds CMS' statutory authority and places an unreasonable burden on physicians.
ASH Submits Letter to Congress Underscoring the Urgent Need for New Antibiotics
ASH joined over 50 organizations in sending a letter to Congress concerning the serious and growing problems of antimicrobial resistance and the dry pipeline for antibiotic research and development in upcoming Food and Drug Administration (FDA) Prescription Drug User Fee legislation. The letter is part of a larger initiative ASH endorsed in 2010: The Infectious Diseases Society of America's (IDSA) 10 X '20 initiative to bring 10 new, desperately needed antibiotics to market by 2020. Read more.
News from ASH
Register for ASH's March Webinar on Thrombosis and Cancer
Registration is open for the ASH Webinar on Thrombosis and Cancer, scheduled for March 26 at 8:00 p.m. ET. This Webinar is designed to provide a practical approach to the issue of thrombosis and cancer confronted by the busy practitioner on a daily basis. Speakers will discuss risk assessment of VTE in cancer patients, review a practical approach to VTE treatment in cancer patients, and address the specific issues of antithrombotic management in cancer patients with centrally placed venous access. For more information about this and other ASH webinars, visit www.hematology.org/webinars.
Earn CME Credits from Blood
ASH, in partnership with Medscape, provides monthly opportunities to earn Continuing Medical Education (CME) credits by completing an Accreditation Council for Continuing Medical Education (ACCME) accredited activity in Blood. This month's activity is titled "The Strategy for the Diagnosis of IPA Should Depend on Both the Underlying Condition & Leukocyte Count of Patientsts with Hematologic Malignancies."
Take Advantage of ASH's Consult a Colleague Service
Consult a Colleague is a service for ASH members that helps facilitate the exchange of information between hematologists and their peers. The full list of available categories is below:
- Hematopoietic Cell Transplantation
- Lymphoproliferative Disorders
- Multiple Myeloma & Waldenström's Macroglobulinemia
- Myeloproliferative Disorders
- Myelodysplastic Syndromes
To learn more or to submit a request, visit www.hematology.org/consult. Assigned Colleagues will respond to inquiries within two business days either by email or phone.
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