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Side Effects >  Shortages of Vital Blood Cancer Drugs!

Reporting Adverse Drug Reactions

Last Update: 12/02/2013

Shortages of Vital Blood Cancer Drugs

Reasons Cited | Proposed Solutions
 

NEWS

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The ASCO Post, 2013:
FDA Announces Strategic Plan to Prevent Drug Shortages http://bit.ly/1bDrzXR 

snip:

The strategic plan, which was required by FDASIA and has been sent to Congress, describes actions the FDA will undertake to improve its current efforts to respond to early notifications of a potential shortage. These include improving the FDA’s communications about shortages, clarifying manufacturers’ roles and responsibilities by encouraging them to engage in certain practices that will reduce the likelihood of a shortage, updating the FDA’s internal procedures for responding to early notifications of potential shortages.

The plan also describes efforts the FDA is considering to address the manufacturing and quality issues that are most often the root cause of drug shortages. These include broader use of manufacturing metrics to assist in the evaluation of manufacturing quality, as well as incentives for high-quality manufacturing; internal organization improvements to focus on quality; and risk-based approaches to identify early warning signals for manufacturing and quality problems.

 
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Shortages - Dr Len's Cancer Blog: FDA: The Quality Problems Causing The Drug Shortage Were Not News To Those Making The Medicines
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Shortages - Medscape: Stopgaps Avert Methotrexate and Doxil Shortages -- For Now
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Shortages - NYTimes: Shipments From Abroad to Help Ease Shortage of Two Cancer Drugs
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Denialism blog: Drug Shortages Reveal the Free Market is Failing Our Sickest Patients
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Shortage - ASH: American Society of Hematology statement on critical methotrexate drug shortage
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Shortages - Dr Len's Cancer Blog: The Cancer Drug Shortage: Patients And Families Deserve Better
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Shortages - Medscape: Methotrexate Crisis: Rationing of Resources is 'Unacceptable'
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Shortages - MSNBC: Amid shortages, rules force hospitals to trash scarce drugs
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Shortages - PBS News Hour: What's Causing a Shortage of Pediatric Cancer Drugs?
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Shortages - WSJ:  Sebelius Says Leukemia-Drug Shortage Will Be Resolved Within Two Weeks  

Good news on this drug, but we wonder about shortages of other critical cancer drugs.
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MSNBC: Drug Shortages hits all time high
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ASCO Post - Chemotherapy Drug Shortages: A Preventable Human Disaster

"In the United States, the solution is simple: Revise the Medicare rule so that generic drugs could be priced at 10% to 20% of the price of the brand-name equivalent, depending on the price of the brand name, and allow for price adjustments of 10% to 20% every 6 months based on changes in the average sales price. This ensures manufacturers a reliable profit margin and offers an incentive to continue producing the drug."
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NEJM: The Shortage of Essential Chemotherapy Drugs in the United States
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NY Times: Obama Tries to Speed Response to Shortages in Vital Medicines
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The Marietta Daily Journal: The cruelest cut: Cancer practice says lower reimbursement would devastate patient care
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Medscape: Private Oncology Practices Blamed for Ongoing Drug Shortages
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Washington Post: Cancer treatment costs can be prohibitive, even with insurance
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PharmaTimes: US drug shortages soar, Congressman probes "grey" marketeers
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PharmaTimes: US drug shortages soar, Congressman probes "grey" marketeers
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NPR transcript and audio: Shortages Lead Doctors To Ration Critical Drugs
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USA Today: A life and death wait for cancer medications in short supply
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Science-Based Medicine:
Who’s to Blame for Drug Shortages?
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Fixing the Drug Shortage:
 

It’s About Time By Derek Raghavan, MD, PhD
"Frankly, I don’t know how the hematologists who treat blood cancers can sleep at night."
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Cancer Drug Shortages Are Placing Patients at Risk - Shortages are approaching crisis point  Medscape.com
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Oncology drugs currently experiencing shortages: NCCN.org
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Oncology Times:  
Oncology Drug Shortages Worsening, Threatening Patient Care
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NY Times:  
U.S. Scrambling to Ease Shortage of Vital Medicine
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Comprehensive list of drug shortages johalimedical.com
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NY Times:
Shortchanging Cancer Patients
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Susan Krivacic's Letter to
Senator Kay Bailey Hutchison

Actions You Can Take:

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Shortages - LLS: Take action against drug shortages
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Call and Write your Senator to urge support for:  Preserving Access to Life Saving Medications Act (S. 296)
 
Details: www.ashpintersections.org
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Call and Write your Congressional representative to urge support for:
H.R.2245 -- Preserving Access to Life-Saving Medications Act


Details: http://thomas.loc.gov

Where is the sense
of urgency?

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NEWS: Cancer Care Advocates Urge Deficit Committee to Oppose $3 Billion Medicare Cut to Life-Saving Cancer Drugs

See also How to Report Drug Shortages

Bleomycin | Daunorubicin | Doxorubicin | Etoposide | Thiotepa | Vincristine

Reasons for shortages cited by advisors to PAL:

Special thanks to Susan Krivacic (advisor to PAL) for sharing her informed perspectives and research who also wrote:

"I would favor the incentive for the generics industry as they have always struggled and now there mode of operation is to go for revenue and profits so that they can just stay in business. We need to give them the carrot not the stick-if that is new legislation to increase the cost of generics by cents or just $1 dollar, I am all for that so that people's lives will be saved."

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Temporary shortages appear to be related to:
 
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Manufacturing problems,

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Distribution disruptions,

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Difficulties obtaining raw materials,

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Regulation issues and even natural disasters.

But the above tend to be temporary.

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Longer-lasting shortages appear to be related to drug manufacturer’s business decisions to:
 
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discontinue or cut back production,

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consolidation of manufacturers, particularly generic manufacturers, and
 

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Current Medicare regulation and reimbursement (Part D)-
See NY Times: Shortchanging Cancer Patients

Susan writes:  "The generic drug manufacturer is a low margin business and with many of the highly marketable compounds having come off patent over the past several years, their focus has turned to quickly doing bioequivalence studies (e.g. clinical trial studies) so as to manufacture more high demand drugs."
 

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The need to notify the FDA of impending discontinuations or shortages.

Proposed solutions to protect patients ...
that have NOT yet gained traction.

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Allow companies to achieve profitability, especially generic manufacturers of medically necessary and life-saving medications. 

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Create financial incentive such as a tax credit to manufacturers that produce life-saving drugs, increasing some of the prices for generic life-saving drugs.

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Build statewide stockpiles of necessary and life-saving drugs.

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Expedite approval for raw material suppliers that can step in when needed.

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Streamline regulatory processes and expediting approval of changes to manufacturing lines.

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Provide tax incentives for the construction of new facilities and generic manufacturers. 

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Provide incentives to manufacturers for training and educating the workforce that is needed for the industry’s future. 

bullet Support current legislation to require advance notification of the discontinuations of vital drugs:
 
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Call and Write your Senator to urge support for:
Preserving Access to Life Saving Medications Act (S. 296)
 
Details: www.ashpintersections.org
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Call and Write your Congressional representative to urge support for:
H.R.2245 -- Preserving Access to Life-Saving Medications Act


Details: http://thomas.loc.gov

 


Information on Blood Cancer drugs
copied 6/10/2011 from FDA.gov


Bleomycin Injection (updated 6/3/2011)
Company/Products Reason Related Information
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)
Product discontinued Bedford currently has all presentations discontinued.
Hospira Inc. Customer Service:
1-877-946-7747

15 unit vial (NDC 61703-0332-18)
30 unit vial (NDC 61703-0323-22)
Higher than anticipated market demand.

Products 15 unit vial (NDC 61703-332-18) and 30 unit vial (NDC 61703-323-22):  next release in June.

 

Please check with your wholesaler for available inventory.

 

Daunorubicin hydrochloride solution for injection  (updated 5/10/2011)
Company/Products Reason Related Information
Teva Pharmaceuticals
1-800-545-8800

5 mg/mL, 4 mL single-dose vial (NDC 00703-5233-13)
Manufacturing issues Teva has daunorubicin solution for injection on back order and estimates a release date of August, 2011.
Bedford Customer Service
1-800-562-4797

5 mg/mL, 4 mL single-dose vial (NDC 55390-0108-10), 10 mL single-dose vial (NDC 55390-0108-01) Cerubidine lyophilized powder for injection, 20 mg single-dose vial, package of 10 (NDC 55390-0281-10)
Manufacturing delays Bedford will release 20 mg lyophilized powder for injection in early May. Bedford will release daunorubicin solution for injection, 20 mg and 50 mg, in the next 3-months.

 

Doxorubicin (adriamycin) lyophilized powder (updated 5/10/2011)
Company/Products Reason Related Information
Bedford

10 mg vials (NDC 55390-0231-01)

20 mg vials (NDC 55390-0232-10)

50 mg vial (NDC 55390-0233-01)
Manufacturing delays Bedford anticipates release of all presentations in the next 6-months.

 

Doxorubicin Solution for Injection (updated 5/10/2011)
Company/Products Reason Related Information
APP
1-888-386-1300
APP Product Availability Information8disclaimer icon9
Increased demand APP is releasing the 2mg/ml 100 ml vials (NDC 63323-0101-61), the 2mg/ml 25 ml vials (NDC 63323-0883-30), and the 2mg/ml 5 ml vials (NDC 63323-0883-05) as it becomes available.
Teva Pharmaceuticals
1-800-545-8800
Manufacturing delays Teva is releasing all strengths on allocation: Doxorubicin solution for injection, 2 mg/mL 5 mL vial (NDC 00703-5043-03) 25 mL vial (NDC 00703-5046-01) 100 mL vial (NDC 00703-5040-01).
Bedford
1-800-562-4797
Manufacturing delays Bedford anticipates release of the 50mg presentation in the next 3months and release of the 10 mg, 25 mg, and 100 mg solutions in the next 6-months.

 

Etoposide solution for injection (updated 5/10/2011)
Company/Products Reason Related Information
Bedford
1-800-562-4797
Increased demand Bedford anticipates release of 500 mg product in early May, 1g in the next 3-months, and 100 mg in the next 6-months.
Teva Pharmaceuticals
1-800-545-8800
Manufacturing delays Teva has Toposar 20 mg/mL solution for injection 5 mL vials (NDC 00703-5653-01) vials availalbe. The 25 mL and 50 mL vials are on back order.
APP
1-888-386-1300
Manufacturing delays APP is releasing all etoposide solution for injection 20 mg/mL presentations as they become available.
BMS Customer Service
1-800-426-7644
Increased demand BMS has available Etopophos 100 mg powder for injection (NDC 00015-3404-20).

 

Thiotepa for Injection (updated 5/13/2011)
Company/Products Reason Related Information
Bedford Laboratories
Customer Service
1-800-562-4797


15 mg/mL vial (NDC 55390-0030-10)
Manufacturing delays Bedford anticipates release mid-May.
Adienne   Adienne, in conjunction with the FDA, is initiating a temporary importation of Thiotepa for injection, to the United States market. Please see the Dear Healthcare Professional Letter (PDF - 1MB)25 for information about emergency supplies that are now available to help address the shortage.

 

Vincristine Sulfate Injection (updated 6/3/2011)
Company/Products Reason Related Information
Hospira Inc. Customer Service: 1-877-946-7747

 

1 mg/mL; 1 mL vial

(NDC 61703-309-06)
1 mg/mL; 2 mL vial

(NDC 61703-309-16)
 


 
Higher than anticipated market demand.

Product 1 mg/mL; 1 mL vial (NDC 61703-309-06): ample levels of inventory to support market demand.

 

Product 1 mg/mL; 2 mL vial (NDC 61703-309-16):  next release in June, with ample levels of inventory to support market demand achieved by July.

 

Please check with your wholesaler for available inventory.

Teva Pharmaceuticals
1-800-545-8800
  Teva has 1 mg/mL 1 mL vial (NDC 00703-4402-11) and 2 mL vial (NDC 00703-4412-11) now available and is shipping to wholesalers.

 


How to Report a Drug Shortage

Non-biologic - call FDA: (888) 463-6332
Biologic - call FDA: (301) 827-4239 | EMAIL:
CBERshortages@fda.hhs.gov

(biologic drugs include blood, vaccines, tissue, allergenics),

ALERT - DRUG SHORTAGES!

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Updates from FDA on Current Drug  Shortages
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ASCO in Action Alert:  Dr. Michael Link, ASCO President-Elect, on the Ongoing Drug Shortage Crisis http://bit.ly/ePzQT4 

MORE ON REPORTING A DRUG SHORTAGE:

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To report a CDER product by EMAIL to FDA: drugshortages@fda.hhs.gov
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To report a non-biologic (CDER) product by PHONE to FDA:
CDER Drug Information (888) INFOFDA or (888) 463-6332, or (301) 796-3400
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To report a biologic (CBER) product shortage to FDA (biological and related products including blood, vaccines, tissue, allergenics), by EMAIL: CBERshortages@fda.hhs.gov
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To report a biologic (CBER) product shortage to FDA by PHONE

(biological and related products including blood, vaccines, tissue, allergenics),

biological product manufacturers and healthcare personnel may report a real or suspected biological product shortage by calling
(301) 827-4239.
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To report shortage to ASHP

use the Drug Product Shortages Report form1 (non-FDA site) available from the American Society of Health-Systems Pharmacists (ASHP)2 web page.

When you use this form, you are reporting a drug shortage to ASHP, not FDA. CDER partners with ASHP to minimize drug shortages and report rapid accurate drug shortage information.


Reporting Adverse Drug Reactions

Note: The FDA encourages consumers to help report adverse drug reactions (ADRs):   

"MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions and problems with medical products, such as drugs and medical devices.

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MedWatch Adverse Event Reporting ~ Home page FDA
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Go directly to FORM for adverse event reporting PDF
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MedWatch Safety Information  FDA

Safety Alerts for Drugs, Biologics, Devices, and Dietary Supplements 
Medical product safety alerts, Class I recalls, market withdrawals, public health advisories
 

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Mandatory Reporting Form 3500 - PDF 
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Voluntary Reporting Form 3500A -  PDF 

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help us evaluate your report.

However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself via the internet."  - FDA.

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For all medical concerns,  you should always consult your doctor. 
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