COA Patient Advocacy Network Drug Shortages, Oral Chemotherapy Orlando, Community Oncology Alliance

Drug Shortages as dangerous as a Florida Alligator 2Community Oncology Alliance

Chemotherapy Drug Shortages What? When? Where? Why? Who?

The What? FDA lists 122 drugs in short supply, are used in cancer care All are generic, “low cost” products

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122 Drugs in short supply  Drug Shortages Drug Shortages  Current Drug Shortages Index Current Drug Shortages Index  Current Drug Shortages A - D Current Drug Shortages A - D  Current Drug Shortages E - K Current Drug Shortages E - K  Current Drug Shortages L - N Current Drug Shortages L - N  Current Drug Shortages O - R Current Drug Shortages O - R  Current Drug Shortages S - Z Current Drug Shortages S - Z  Resolved Drug Shortages Resolved Drug Shortages  Drugs to be Discontinued Drugs to be Discontinued  How to Report a Shortage or Supply Issue How to Report a Shortage or Supply Issue  Frequently Asked Questions About Drug Shortages Frequently Asked Questions About Drug Shortages

 A  Acetylcysteine Inhalation Solution1 10/15/2012 Alfentanil Injection2 (initial posting 1/23/2012) Amikacin Injection3 Amino Acid Products4 (initial posting 2/14/2012) 10/15/2012 Ammonium Chloride Injection5 Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%6 (initial posting 9/18/2008) Amphetamine Mixed Salts, ER Capsules7 (initial posting 10/31/2011) Amphetamine Mixed Salts Immediate-Release Tablets8 (initial posting 1/12/2012) Aquasol A9 Atracurium besylate10 (initial posting 2/27/2012) Atropine Sulfate Injection11 Acetylcysteine Inhalation Solution Alfentanil Injection Amikacin Injection Amino Acid Products Ammonium Chloride Injection Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Amphetamine Mixed Salts, ER Capsules Amphetamine Mixed Salts Immediate-Release Tablets Aquasol A Atracurium besylate Atropine Sulfate Injection

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Atropine  Shortage per Manufacturer: American Regent/Luitpold has discontinued manufacturing the ampoules  Product will be made available as it is released.Shortage per Manufacturer: Increase in product demand.  Shortage per Manufacturer: Increase in product demand caused by market supply issues.  Please check with your wholesaler for available inventory. Shortage per Manufacturer: Manufacturing delay

The When? Medicare Modernization Act (MMA) Few if any shortages prior to 2003 Reimbursement set at 6 % of ASP Unintended consequence of legislation

The Where? Community Oncology Clinics Over 80 % of cancer patients treated Hospital/Academic cancer clinics have protection under 340B for pricing but suffer same challenges of drug shortages.

The Why?  Cause of Drug shortages is economic  Majority of drug shortages occur where profitability is low  AWP + 6% can be less than the cost to give the drug  Manufacturing Pressures, Quality, Regulation, Cost  Race to the bottom in cutting costs

WHO? Patients Physician staff Pharma Politicians Brenda

Brenda’s Story

Brenda’s Chemotherapy Shortage Diagnosed in 1996 with Breast Cancer rx’ed lumpectomy and XRT BRCA 1 positive, mother died from breast cancer Stage III ovarian cancer in 5/2006 Carbo, taxotere, gemcitabine, topotecan, cisplatin, Doxil started 11/2010 with good control of disease

Doxil unavailable, 8/2011 Doxil unavailable 8-11 Progressive disease and admitted with bowel obstruction, Liposomal Doxorubicin from India available and rx’ed , with control of disease

Doxil Shortage  Janssen Products, LP (formerly Centocor Ortho Biotech Products, L.P.) (1-800-JANSSEN)Doxil 2 mg/mL, Janssen Products, LP 2 mg/mL, 10 mL (20 mg) vial (NDC ) Please see mber2011.pdf28 29 for additional information. mber2011.pdf  Important Updates on DOXIL Supply Shortage Important Updates on DOXIL Supply Shortage  Shortage per Manufacturer: Manufacturing delays

URGENT – Doxil® (Doxorubicin Hydrochloride Liposome Injection) Shortage Update January 27, 2012 Dear Healthcare Professional  At this time, FDA’s regulatory discretion for the importation and distribution of Sun Pharma’s LipodoxTM (Doxorubicin Hydrochloride Liposome Injection) is limited to Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd, during the critical shortage of Doxil.

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Medical Roller Coaster

Chemotherapy Drug Shortages What? 122 Drugs/12 Cancer When? 2003 Where? Everywhere Why? Economic Who? Brenda

Prognosis of Drug Shortage The condition is serious caused by multiple factors the greatest of which is economic. Low profitability on generic manufactured drugs will to discourage production. Pressure or enticement to ensure adequate drug supply is necessary

Solutions(Or why it isn’t as bad as it seems)  Drugs from India: Doxil  Legislation: FDA Safety and Innovation Act  Robust options for treatment  Health-care professionals have been sharing resources and supplies of various drugs including those used in chemotherapy treatment  Gray Market/Stockpiling fraud control  Obligation by Pharma to produce drugs at reduced margins

Drug Shortages Provisions in Public Law No: , FDA Safety and Innovation Act  On July 9, 2012 President Obama signed into law legislation  Notification Requirements  Expedited Inspections and Reviews  Repackaging guidance  Reports, Strategic Plan and Study

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