Pediatric Cancer Drug Shortage Update

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Date: July 12, 2020 7:13 AM

Asparaginase Erwinia

Asparaginase Erwinia: The U.S. Food and Drug Administration’s most recent list of drug availabilities says it is out of stock. Many major hospitals are reporting shortages. If the drug, manufactured by Jazz Pharmaceuticals (800 520-5568), is missed, it can’t simply be given when it is available. It can only be resumed later, depending on the other drugs that are part of the child’s treatment plan. The shortages have persisted across North America. For over two years there have been supply problems with this drug used to treat certain children with ALL who are not able to take the E. coli bacterium version of asparaginase used in most patients. “A recent study suggests that certain children with acute lymphoblastic leukemia who skip even one treatment of erwinia asparaginase may have lower survival rates than those who didn’t miss a treatment”.

Here is an article from November 2019 covering the shortages in Ottawa then: https://ottawacitizen.com/…/two-children-miss-cancer-treatm…

FDA Guidance:  Out of stock. For further information and to sign up for supply alerts by Jazz Pharmaceuticals please visit Erwinazesupply.com  https://erwinazesupply.com/

Jazz Pharmaceuticals states “the earliest we expect having product available for ordering is the week of August 3, 2020.”


Senators Susan Collins, R-ME and Tina Smith D-MN, in addressing drug shortages, have introduced S. 2723 Mitigating Emergency Drug Shortages Act. Vincristine was also in short supply from September 2019 until January 2020. Information on the bill is available here: https://wp.me/P2TETU-1LK 





Date: February 1, 2020 7:30 am   FDA reports that vincristine shortage has been resolved.


Date: November 18, 2019, 7:30am

DrugShortagesSML_edited-1The MEDS Act, S. 2723, introduced two weeks ago by Senators Susan Collins, and Tina Smith will provide additional authority to the FDA to help mitigate drug shortages and develop incentives to help ensure stable supplies of such vital medications as vincristine. Children can not afford to be without life-saving meds. Information on the Act, details, text, and endorsement form  are all available here: S. 2723


November 18, 2019: Teva announced that it intends to resume manufacturing vincristine in one of it’s US locations. It is anticipated supplies will be available in early 2020.

Teva


October 31, 2019:  FDA issued a report on drug shoartages:   Report | Drug Shortages: Root Causes and Potential Solutions

FDA DrugShortage ReportThe report examines the underlying factors responsible for drug shortages and recommends enduring solutions. It identifies three root causes for drug shortages and also recommends three enduring solutions to address drug shortages. In addition, the report describes legislative proposals in the President’s FY2020 Budget and planned FDA initiatives to prevent and mitigate shortages in the future.

 


10/24/19: Information from Children’s Oncology Group on Vincristine. Dr. Peter Adamson, Chair of the Children’s Oncology Group (COG) stated in a special Webinar, October 23, 2019 on Vincristine shortages stated that any child that is not getting vincristine who needs it, would be able to receive it. Pfizer has a supply for emergency shipment to those in need. A special phone number has been created and is being distributed to all 200+ COG hospitals. The special Pfizer phone number will be restricted to hospitals use only.  COG hospitals treat over 90% of children who receive vincristine and other chemotherapies.  All oncologists who are treating children in a non-COG affiliated hospital and do not have vincristine available will be able to contact Pfizer by contacting the Children’s Oncology Group. 

If you would like to see the Webinar that took place on 10/23/2019 CLICK HERE


Webinar on Vincristine and childhood cancer drug shortages, attended by over 400 interested people, was held on October 23, 3:00pm.  The Alliance for Childhood Cancer and the Coalition Against Childhood Cancer invited members of the two coalitions and the general public to an informational webinar presented by Dr. Peter Adamson, Chair of the Children’s Oncology Group. Dr. Adamson shared information the COG has received along with a perspective on childhood cancer drug shortages, including the current situation with vincristine. This webinar was held so that the community will have a better understanding of the shortage, how to work with care providers, how to contact the FDA when problems arise from the shortage, and advocacy steps being taken.


Letter to Childhood Cancer Community regarding vincristine shortage from Pfizer Inc. Hospital Division

Shipments of vincristine will be arriving late October, 2019 for both sizes.   Product short supply period expected to be over by January 2020 for 1 mg/mL Single Dose Glass Fliptop Vial (NDC 61703-0309-06)  and December, 2019 for 2 mg/2 mL (1 mg/mL) Single Dose Glass Fliptop Vial (NDC 61703-0309-16)

From the FDA

“New Availability information for vincristine is posted on the FDA Drug Shortage website and will be updated as additional information becomes available. Please know that we understand how critical this drug product is and we will do all that we can, within our authority, to help the manufacturer have product more readily available. Thank you.”

Click here to be directed to the FDA Drug Shortage Website


Letter to Childhood Cancer Community regarding vincristine shortage from Children’s Oncology Associates


October 15, 2019: Sound Off

Would you like to tweet members of the government to let them know how big this problem is for you and your family? Here’s a sample tweet. There is enough room at the bottom to add your Representative and Senators.

We need to solve the #VincristineShortage at once. #ChildhoodCancer kids need it now! @SecAzar @FDACommissioner @NIHDirector @NCIDrDougLowy @POTUS @SpeakerPelosi @GOPLeader @senatemajldr @SenSchumer @FrankPallone  @RepGregWalden  @SenAlexander @PattyMurray