9/19/19
Dear members of the Mast Cell Disease community,
As always, TMS is committed to representing all mast cell diseases including mastocytosis, mast cell activation syndrome, MCA, and HaT in terms of our resources and mission. We have become aware that our physicians are possibly considering incorporating new criteria to the existing proposed consensus criteria (Valent, et.al.) for mast cell activation syndrome. We are concerned that adding anaphylaxis as a criteria for MCAS may not reflect the patient experience that patients report. In addition, we have reservations about the description of symptomatology in MCAS patients as only episodic to the exclusion of daily symptoms. To this end, we are communicating our concerns to the TMS Medical Advisory Board, the AAAAI Mast Cell Disorders Committee, and the European Competence Network in Mastocytosis. As always, TMS is committed to representing all mast cell diseases including mastocytosis, mast cell activation syndrome, MCA, and HaT in terms of our resources and mission. We look forward to updating you on the response as soon as we receive it.
From the TMS Board of Directors and Committee Chairs
11/12/18
Diphenhydramine Shortage – We need your help!
The Mastocytosis Society, Inc. is continuing to work with pharmaceutical companies and the FDA to help patients during this life-threatening intravenous and injectable diphenhydramine shortage. That said, the fact remains that currently, of the five companies listed on the FDA website, only two are making products that may be available in 2018 but with no guarantee.
We know that many in our patient community rely on this medication to manage and prevent life-threatening mast cell reactions. We are particularly concerned for those most critically-ill.
While our work will continue with the pharmaceutical companies we know that there must be a broader community awareness effort.
Please join us in contacting the FDA and your elected officials letting them know about the impact this shortage is having on you and your community. An email template that can be used and personalized to send to the FDA and your elected officials is below.
Please feel free to also ask others to join us in our outreach as we know we will be stronger together. Thank you for your efforts to help bring attention to this drug shortage crisis.
For Affected Patients
If you are currently affected by this shortage and unstable please email nurses@tmsforacure.org. Please include your name, the name of your physician who prescribes it, your dose mg/hr, vials/day for CDI and any extras for rescue boluses, your email address and phone number, your pharmacy or infusion company and phone numbers and the statement: “On [month] [day], 2019, I agree to let the TMS nurses share this information with pharmaceutical companies who make IV diphenhydramine.”
Please send Letters to the FDA and Elected Officials – Templates Below
FDA Template
Please personalize and send the below letter to the FDA Commissioner, Dr. Scott Gottlieb. Please email him at CommissionerFDA@fda.hhs.gov.
Dear Dr. Scott Gottlieb,
As an advocate of The Mastocytosis Society, Inc. and for all patients living with Mast Cell Diseases, I am writing today in regards to the documented FDA Shortage of intravenous and injectable diphenhydramine solution. It is critical that the agency understand how dangerous this shortage is to me and all mast cell disease patients.
This medication is used during an emergency or as a continuous diphenhydramine infusion (CDI) to prevent and treat life-threatening mast cell attacks which can include anaphylaxis.
We are asking that you help facilitate the increased production of this product to ensure its availability this year, in 2018. Additionally, we urge you to consider accessing the drug from safe sources outside the United States until the supply is replenished.
We thank you in advance for your attention to this matter and immediate action towards a solution.
We know of many patients already in critical care due to this shortage. Without immediate assistance, we face an inevitable and unacceptable loss of life.
Please contact The Mastocytosis Society, Inc.’s Drug Shortage Committee at chairman@tmsforacure.org at your earliest convenience.
Thank you,
Insert name
—
Elected Official Template
Please use the template below to personalize and send to your state’s elected officials.
For a listing of contact information for your senator please visit: https://www.senate.gov/general/contact_information/senators_cfm.cfm
For a listing of contact information for your representative please visit:
https://www.house.gov/representatives
Dear (Insert your elected official)
As an advocate of The Mastocytosis Society, Inc. and for all patients living with Mast Cell Diseases, I am writing today in regards to the documented FDA Shortage of intravenous and injectable diphenhydramine solution. It is critical that you understand how dangerous this shortage is to me and all mast cell disease patients.
This medication is used during an emergency or as a continuous diphenhydramine infusion (CDI) to prevent and treat life-threatening mast cell attacks which can include anaphylaxis.
We are asking that you reach out to the FDA and urge them to help facilitate the increased production of this product to ensure its availability this year, in 2018. Additionally, we ask that you please also urge them to consider accessing the drug from safe sources outside the United States until the supply is replenished.
We thank you in advance for your attention to this matter and immediate action towards a solution.
We know of many patients already in critical care due to this shortage. Without immediate assistance, we face an inevitable and unacceptable loss of life.
Please contact The Mastocytosis Society, Inc.’s Drug Shortage Committee at chairman@tmsforacure.org at your earliest convenience.
Thank you,
Insert name
