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COA Patient Advocacy Network
Drug Shortages, Oral Chemotherapy
Orlando, 3-22-13
Community Oncology Alliance
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Drug Shortages as dangerous as a Florida
Alligator
Community Oncology Alliance
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Chemotherapy Drug Shortages
What?
When?
Where?
Why?
Who?
The What?
FDA lists 122 drugs in
short supply, 3-5-13
12 are used in cancer
care
All are generic, “low
cost” products
Community Oncology Alliance
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122 Drugs in short supply
 Drug Shortages
 Current Drug Shortages Index
 Current Drug Shortages A - D
 Current Drug Shortages E - K
 Current Drug Shortages L - N
 Current Drug Shortages O - R
 Current Drug Shortages S - Z
 Resolved Drug Shortages
 Drugs to be Discontinued
 How to Report a Shortage or Supply Issue
 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

Community Oncology Alliance
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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? 2003
2003 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, 1-17-2012
Liposomal Doxorubicin from India
available and rx’ed 1-30-12, 2-27-12
with control of disease
Doxil Shortage
 Janssen Products, LP (formerly Centocor Ortho
Biotech Products, L.P.)
1-800-526-7736
(1-800-JANSSEN)Doxil 2 mg/mL, Janssen Products,
LP
2 mg/mL, 10 mL (20 mg) vial (NDC 59676-096001) Please see
http://www.doxil.com/sites/default/files/DHCP_septe
mber2011.pdf28 29 for additional information.

Important Updates on DOXIL Supply Shortage 30 31
 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: 112-144, 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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