2011 NOS Upcoming Event

Membership Conference: Tuesday, October 11
The Peppermill, Reno

For more information, go to www.nos-nevada.com.

NOS Board of Directors

President
Shamoon Ahmad, MD, FACP
Cancer Therapy & Integrative Medicine Institute

Vice President
Lawrence Dardick, MD
Renown Medical Center

Secretary
Tejvir Singh, MD
Reno Oncology Consultants

Treasurer
Annabel Barber, MD, FACS
University of Nevada, School of Medicine

Trustee/Immediate Past President
Dan L. Curtis, MD
Nevada Radiation Oncology Comprehensive Center West

Trustees

Souzan E. El-Eid, MD, FACS
Comprehensive Cancer Centers of Nevada

Sowjanya Reganti, MD
Alpine Hematology–Oncology

NOS Corporate Partners

(as of 6/30/11)

Platinum
Celgene Corporation

Gold
Genentech, Inc.
Lilly Oncology
Merck & Co.
Novartis Pharmaceutical Corp.

Thank you for the value you add to NOS!

New Logo, New Look!

We hope you enjoy our newly redesigned NOS NewsLine. Please email us if you have any questions, comments, or news you'd like to see appear in the next NewsLine.

— Summer 2011 —

President's Message: Drug Shortages–No End in Sight
Shamoon Ahmad, MD, FACP

Many physician practices and hospitals across the United States have struggled with drug shortages for the past two years. The situation is especially dire for small rural hospitals and small practices that lack volume and buying advantage, which allows larger purchasers to receive drugs on a preferential basis from distributors.

The number of drugs in shortage jumped from 67 in 2005 to 178 in 2010, according to the Food and Drug Administration (FDA), which said, "FDA is doing everything within its regulatory authority to address these shortages when they occur. The FDA has taken the unusual steps in this regard. In some situations, FDA uses its regulatory discretion for a foreign ver¬sion of a product to be imported on a limited basis until U.S. needs can be met by an FDA-approved version of the drug." It is interesting to note that half of all medical devices used in this country are imported, while 80 percent of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere. (Source: FDA Special Report 2011)

How to Deal with Shortages: Please refer to an informative article by the American Society of Health-System Pharmacists (ASHSP) at www.ashp.org, which talks about actions and thoughts for dealing with drug shortages. Some recommendations and comments are as follows:

• Having more than one distributor is recommended as each distributor may have access to different items and might offer preferential pricing for difficult to obtain drugs.
• Keep a larger inventory of scarce drugs.
• Be cautious of new distributors and the drugs shipped by them. There are reports of vendors importing and shipping drugs using non-FDA approved importation channels. Be careful of foreign language labels. FDA's decision to allow importation of foreign versions of drugs will blur any label distinctions that may currently exist.

In addition to ASHSP's website, you may find out about drug shortages by going to the FDA's website, and you may report any shortages your practices are experiencing to the FDA at drugshortages@fda.hhs.gov. I encourage you to do so.

I also encourage all NOS members to write their elected representatives in Washington, DC in support of S 296/HR 2245, Preserving Access to Life-Saving Medications Act, and to share with them the problems these shortages are causing you in planning the most effective treatment regimens for your patients. Although these bills, which require manufacturers to report impending manufacturing stoppages to the FDA, is not perfect, it is a step in the right direction. The legislation is supported by such organizations as ACCC, ASCO, COA, and ONS, which are collaborating to provide a briefing on this subject on Capitol Hill on July 13 for Members of Congress and their staff. Make sure your federal officials hear from you, too!

In other news, NOS sponsored a well-attended Spring Membership Conference in Las Vegas in April. Please plan on attending the Fall Membership Conference in Reno on Tuesday, October 11.

Summer temperatures are closing in quickly so enjoy the mild weather we have had recently. I hope everyone has a wonderful summer!

Drugs in the News from NOS Corporate Partners

NOVARTIS PHARMACEUTICALS CORPORATION (www.novartis.com) announced that the FDA has approved Afinitor® (everolimus) tablets for patients with subependymal giant cell astrocytoma (SEGA), a benign brain tumor associated with tuberous sclerosis (TS), who require therapeutic intervention but are not candidates for curative surgical resection. (Oncology Issues, January/February 2011)

GENENTECH, a member of the Roche Group, and Biogen Idec (www.gene.com) announced that the FDA has approved Rituxan® (rituximab) as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy (induction treatment). This approval was based on data from the Phase III PRIMA study, which showed continuing Rituxan administration every two months for two years in patients who responded to initial treatment with Rituxan plus chemotherapy, nearly doubled the likelihood of them living without the disease worsening (progression-free survival) compared to those who stopped treatment. (Oncology Issues, March/April 2011)

The FDA approved SCHERING CORPORATION'S (www.merck.com) Sylatron™ (peginterferonalfa-2b) for the treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection, including complete lymphadenectomy. The approval was based on a single trial, EORTC18991, an open label, multi-center trial enrolling 1,256 patients. The recommended dose and schedule for Sylatron is 6 mcg/kg/week, subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously. The maximum treatment period is 5 years (260 weeks). Sylatron is contraindicated in patients with a history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b, in patients with autoimmune hepatitis, and in patients with hepatic decompensation (Child-Pugh score >6 [class B and C]). (Oncology Issues, May/June 2011)

The FDA approved Afinitor® (everolimus) Tablets (NOVARTIS PHARMACEUTICALS CORPORATION, www.novartis.com) for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. (Oncology Issues, July/August 2011, in press)

CELGENE CORPORATION (www.celgene.com) announced that the FDA has granted accelerated approval for its supplemental new drug application (sNDA) for an additional indication for Istodax (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy. Istodax is also approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. (Celgene Corporation, Press Release, June 16, 2011).

Welcome New NOS Members!

Cheryl Martin, MSN
Nevada Cancer Institute, Las Vegas, Nev.

John Ruckdeschel, MD
Nevada Cancer Institute, Las Vegas, Nev.

Navneet Sharda, MD
Cancer Care Centers, Las Vegas, Nev.

For more information about Nevada Oncology Society (NOS)
go to www.nos-nevada.com or call 301.984.9496, ext. 218

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