Drug Shortages Rise to Crisis Level (Updated)

2011-04-26

The United States is currently experiencing drug shortages, particularly for generic drugs. Shortages of drugs used to treat patients with hematologic malignancies, including leukemia and lymphoma, have become critical and life-threatening. An increasing number of physicians have been forced to take their patients off therapies mid-treatment, delay treatment, choose alternative therapies that are less effective, and ration their remaining supplies of these therapies. ASH has also heard from several institutions and practices that have instituted stringent protocols and procedures regarding the use of certain drugs that are in short supply, such as BiCNU (Carmustine), Cytarabine (ARA-C), and Thiotepa. For example, one cancer clinic has halted all clinical trials using ARA-C because of the drug shortage, preventing hematologist/oncologists from treating patients with necessary and timely drug therapy.

ASH has taken the following steps to provide our membership and patients they serve with the most up-to-date information to assist them during this critical time while working with policymakers on possible solutions:

  1. Contacted specific drug companies to obtain information about the drugs in short supply, specifically what is causing the delays and when the drugs will become available. Information about specific drug shortages will be posted to the ASH website as it becomes available.
  2. Alerted the Food and Drug Administration (FDA) to the hematology/oncology drug shortages and requested an official response to the matter.
  3. Worked with Senator Amy Klobuchar's office regarding S. 296, The Preserving Access to Life-Saving Medications Act, legislation that would provide the Food and Drug Administration (FDA) with tools to help address and prevent future medication shortages.
  4. Notified congressional committees of the problem and requested a hearing on this issue.

In addition, while there are no evidence-based clinical guidelines or protocols for specific drug therapy in times of drug shortage, the Society is working with clinical experts to try to offer "clinical guidance" to our members on alternative treatment protocols, including alternative drugs that may be substituted, in the face of shortages. If you are experiencing problems with a drug shortage, please contact ASH Government Affairs Manager Stephanie Kaplan at skaplan@hematology.org.

Finally, the Society has also developed an advocacy campaign to encourage congressional support of S. 296. We encourage you to use the ASH Advocacy Center to contact your Senators about this issue and its impact on your patients.

For more information on the following drug shortages and other hematology drug shortages, visit the FDA drug shortage webpage.

Drug Name  Company
Information 		 Reason for Shortage  Related Information 
Cytarabine injection (powder for reconstitution) updated 3/17/2011 (Solution)    Bedford Customer Service
1-800-562-4797
100 mg vial (NDC 55390-0131-10)
500 mg vial (NDC 55390-0132-10)
1 gram vial (NDC 55390-0133-01)
2 gram vial (NDC 55390-0134-01) 		Manufacturing delays

 

 Bedford has all cytarabine presentations on back order.

 
APP
1-888-386-1300
100 mg/mL, 20 mL vial (NDC 63323-0120-20)		 Manufacturing delays Limited supplies available - please see Dear Healthcare Professional Letter (PDF - 43KB)7 for important information. APP has been able to increase production to help address the shortage and estimates additional supplies to be released by end of April.
Hospira Inc. 1-877-946-7747 20 mg/mL; 50 mL PBP (NDC 61703-303-46), 20 mg/mL; 25 mL (NDC 61703-304-36), 20 mg/mL; 5 mL (NDC 61703-305-38), 100 mg/mL 20 mL (NDC 61703-319-22) API shortage/manufacturing delay Hospira will begin releasing additional lots of 100mg/ml 20ml vials on April 11, 2011.

Dear Healthcare Professional Letter (PDF - 75KB)8 
Thiotepa for Injection, Bedford
15 mg/mL vial (NDC 55390-0030-10) 3/29/2011 		Bedford Laboratories Customer Service 1-800-562-4797 unspecified FDA awaiting additional information and will post when available.

Adienne, in conjunction with the FDA, is initiating a temporary importation of Thiotepa for injection, to the United States market. Please see Dear Healthcare Professional Letter (PDF - 1MB) 26for information about emergency supplies that are now available to help address the shortage.
BICNU (carmustine) Injection, Bristol-Myers Squibb
(100 mg, NDC 00015-3012-60) 		 Bristol-Myers Squibb
1-800-332-2056		   BMS has released BiCNU and no further supply issues are anticipated.
Bleomycin Injection APP
1-888-386-1300
15 unit vial (NDC 63323-0136-10), 30 unit vial (NDC 63323-0137-20) 		Increased demand APP is currently back-ordered on all presentations of Bleomycin for Injection at this time. APP is anticipating batch releases to resume in the first quarter of 2011.
Teva Pharmaceuticals
1-800-545-8800		 Manufacturing delays 15 unit vials (NDC 00703-3154-01) and 30 unit vials (NDC 00703-3155-01) are now available and the company is reviewing orders prior to shipping.
Bedford
1-800-562-4797
15 unit vial (NDC 55390-0005-01), 30 unit vial (NDC 55390-0006-01)		 Manufacturing delays Bedford has bleomycin 15 and 30 unit vials on long term back order with no release date.
Hospira
1-877-946-7747
15 unit vial (NDC 61703-0332-18)
30 unit vial (NDC 61703-0323-22) 		Manufacturing delays Backordered until 1Q 2011.

Read a recent Wall Street Journal article and watch a recent ABC News report on this issue.

If you have a question regarding a patient who requires a drug that is in short supply, please utilize the  ASH Consult a Colleague program.

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