Products Affected - Description

Reason for the Shortage

• Bedford has Adriamycin on shortage due to manufacturing delays. Bedford anticipates full availability of each presentation the company reintroduces to market.¹
• Ben Venue voluntarily entered into a consent decree with FDA in late-January 2013 which allows Ben Venue to manufacture over 100 medications as long as they are compliant with the decree. Ben Venue supplies multiple products for Bedford Laboratories, a division of Ben Venue.¹
• Teva had doxorubicin on shortage due to manufacturing issues.²

Available Products

Estimated Resupply Dates

Bedford has all Adriamycin solution for injection and Adriamycin lyophilized powder 20 mg vials on long-term back order. These will not be manufactured until capacity permits.¹

Implications for Patient Care

• Doxorubicin is an anthracycline glycoside agent. It is labeled for use in adults with leukemias, lymphomas, soft tissue and bone sarcomas, and breast, gastric, ovarian, thyroid, small cell lung, and transitional bladder cancers.^6-8
• Doxorubicin is used off-label in adults for treating AIDS-related Kaposi sarcoma, refractory multiple myeloma, Ewing sarcoma, and adrenocortical, endometrial, islet cell, and liver cancers.^6-8
• Doxorubicin is labeled for leukemias, lymphomas, bone and soft tissue sarcomas, neuroblastoma, and Wilms tumor in children.^6-8

Safety

• Chemotherapy agents, such as doxorubicin, pose additional safety risks both for patients and for healthcare workers handling these agents.^6,7
• Use additional caution when processing orders for chemotherapy drugs, especially when switching between chemotherapy agents or when processing orders for chemotherapy agents with which staff may be unfamiliar (eg, those not normally prescribed at a specific institution).^6,7

Alternative Agents & Management

• The choice of an alternative agent must be patient-specific and based on renal function, liver function, and the neoplasm type and location. No single agent can be substituted for doxorubicin.^6-8
• Consider evaluating the health-care system’s total supply of doxorubicin before beginning patients on combination chemotherapy regimens containing doxorubicin. If adequate supplies are not available, select an alternative regimen.
• Consult a Hematology/Oncology specialist for patient- and neoplasm-specific recommendations.
• Refer to the ASHP Guidelines on Managing Drug Product Shortages for more guidance on developing a multidisciplinary plan when the supply must be allocated. 

Related Shortages

• Asparaginase Injection— No Longer Available
• Bendamustine Injection— Resolved
• Bleomycin Injection— Resolved
• Busulfan— Resolved
• Capecitabine Tablets— Resolved
• Carboplatin Solution for Injection
• Carmustine Injection— Resolved
• Cisplatin Injection— Resolved
• Cyclophosphamide Injection— Resolved
• Cytarabine Injection
• Dacarbazine Injection
• Daunorubicin Hydrochloride Injection
• Denileukin Diftitox Injection
• Doxorubicin Liposomal Injection
• Etoposide Injection— Resolved
• Fludarabine Injection
• Fluorouracil Injection
• Gemtuzumab Ozogamicin Injection— No Longer Available
• Idarubicin Hydrochloride Injection— Resolved
• Interferon Alpha-2b, Intron A— Resolved
• Irinotecan Injection— Resolved
• Leuprolide Acetate 14-Day Kit
• Lomustine Capsules
• Mercaptopurine Tablets
• Methotrexate Injection
• Methotrexate Tablets
• Mitomycin Injection
• Paclitaxel Injection
• Pentostatin Injection
• Streptozocin For Injection— Resolved
• Thiotepa for Injection
• Tretinoin Oral Capsules— Resolved
• Vinblastine Injection
• Vincristine Injection— Resolved

1. Bedford (personal communications). May 18, June 22, July 20, August 2, September 2, 13, and 29, October 14 and 22, November 8, 17, and 29, December 17, 2010; January 11, 19, and 21, February 1 and 23, March 1, 22, and 29, April 11 and 18, May 17, June 15, July 20, August 16, September 23, October 24, November 30, 2011; January 3, March 1, April 13, May 9 and 21, June 20, July 11, August 29, September 27, November 26, 2012; January 11, February 6, 11, and 19, March 13 and 28, and April 29, 2013.
2. Teva (personal communications). May 19, June 22, July 20, September 2, 13, and 30, October 14, November 11 and 29, December 16, 2010; January 19 , February 1 and 23, March 22 and 29, April 11, May 19, June 14, August 15, September 22, October 27, November 29, 2011; January 3 and 6, March 12, April 12, May 9 and 21, June 1 and 18, July 12, August 28, October 3, 2012; January 11, February 6, and May 6, 2013.
3. APP (personal communications). May 19, June 22, July 20, September 2, 13, and 29, October 14 and 25, November 12 and 29, December 17, 2010; January 7 and 19, February 1, March 9 and 25, April 11 and 20, May 18, June 8, August 16, September 20, October 25, November 28, 2011; January 4, March 15, April 13, May 9 and 21, June 19, July 9, August 27, October 1, November 26, 2012; January 11, February 4 and 11, March 17 and 29, and April 29, 2013.
4. Caraco (personal communications). May 6, 2013.
5. Pfizer (personal communications). June 20, July 15, August 15, September 20, October 27, November 23, 2011; January 4, March 13, April 11, May 7, June 15, July 12, August 28, November 27, 2012; January 11, February 6, 19, and 22, March 15 and 29, and May 2, 2013.
6. Beckwith MC, Tyler LS, eds. Cancer Chemotherapy Manual. St. Louis, MO: Wolters Kluwer Health Inc. 2010.
7. Antineoplastic agents. In: McEvoy GK, ed. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010: 902-1260.
8. Drug Facts and Comparisons Online. St. Louis, MO: Wolters Kluwer Health Inc. September 2010

Updated

Updated May 6, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist. Created September 21, 2010, by David M. Peterson, PharmD, and M. Christina Beckwith, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.