Share/Bookmark

DOWNLOAD THE BELOW LETTER IN WORD DOC FORMAT

Cure JM Logo

April 16, 2020

Jeffrey Mesaros, Pharm.D., J.D.
Chair
Florida State Board of Pharmacy
Department of Health
4052 Bald Cypress Way
Tallahassee, FL 32399-3258

Dear Dr. Mesaros:

Thank you for your dedicated service to the state of Florida as we all work together to reduce and manage the impact of the COVID-19 crisis.  I write you as the Executive Director of the Cure JM Foundation representing our Florida chapters and families across the state with children who live with a debilitating rare autoimmune disease—juvenile myositis.

Many of these children depend on access to drugs that are being tested or stockpiled for COVID-19.  While we applaud the government’s decision to test a wide array of approved drugs to combat COVID-19, we are deeply concerned that juvenile myositis children, as well as millions of other patients with autoimmune diseases, will be denied access to the drug therapies many of them need to survive.  Specifically, we must assure that our JM children have access to hydroxychloroquine (brand name: Plaquenil) through their local pharmacies.

We are especially concerned that the State of Florida has not acted to protect access to hydroxychloroquine for existing patients who depend on their prescriptions.  Earlier this week I spoke with the Florida grandfather of child with juvenile myositis—a child whose daily maintenance depends on a cocktail of drugs including hydroxychloroquine.  This child’s mother visited six pharmacies in Vero Beach before finding a seventh able to dispense a 30-day supply.  Later in the day, this pharmacy ran out of supply.

Juvenile Myositis (JM) is a debilitating autoimmune disease resulting in severe muscle weakness and frequent immobility.  In JM, a child’s immune system is uncontrolled, attacking healthy tissue and often internal organs such as the heart and lungs.  Without question, JM is an underlying condition, and children or adults with JM would be at higher risk should they actually contract COVID-19.

JM is treated by suppressing an overactive immune system, and first-line treatments often include a mix of drugs such as prednisone, methotrexate, and hydroxychloroquine.  As JM is an idiopathic and heterogeneous disease that can present differently across each child, there is no single course of therapy.  Cure JM’s Medical Advisory Board (comprised of the leading JM medical experts in the world) estimates that 70% of JM patents will use hydroxychloroquine in the course of their disease treatmen

A survey taken last week of JM parents presents important information you may find helpful as you provide guidance to pharmacists in Florida:

  • 37% reported difficulty in having hydroxychloroquine prescriptions filled for their children.
  • 28% reported that their pharmacy was out of hydroxychloroquine supply.
  • 49% reported that their pharmacist cautioned that their local supply could run out in the immediate future.

Results were reported from 35 states, Puerto Rico, and the District of Columbia.

We are hopeful that hydroxychloroquine could prove to be helpful in the treatment of COVID-19, and support the clinical trials which will provide the needed scientific proof of its efficacy in such treatment. To date, however, there is no scientific evidence that hydroxychloroquine is effective in either treating or preventing COVID-19.

Despite this lack of evidence, we are all well aware that hydroxychloroquine is being prescribed by doctors for patients outside a hospital setting, often as a possible—but nevertheless unproven—preventative measure.  As a result, we are seeing widespread shortages in Florida

We must protect existing supplies of hydroxychloroquine in pharmacies for JM children - and other autoimmune patients - who rely on this drug for maintenance and survival.  To fail these patients, where hydroxychloroquine is known to be efficacious and is often a first-line approved immunosuppressive treatment, would only add to the tragic outcomes of the COVID-19 pandemic.

Thank you for allowing me to share the concerns of our Florida families.  We are deeply appreciative of any action that you and the Florida Board of Pharmacy can take to assure access to hydroxychloroquine for patients where it is a prescribed and proven therapy.

We look forward to working with you and members of your staff on this critical access issue.

Sincerely,

Jim

James Minow
Executive Director
Cure JM Foundation
(202) 805-2020