Landstuhl, GERMANY – The U.S. Army Medical Materiel Development Activity's Force Health Protection Investigational New Drug branch hosted its 5th annual meeting at the Landstuhl Regional Medical Center, Landstuhl, Germany, from Sep. 21 – 22.
The annual FHP meeting brought together Department of Defense personnel from USAMMDA, U.S. Army Medical Research Institute of Infectious Diseases, U.S. Army Medical Materiel Center Europe and LRMC to facilitate the use of FHP contingency and endemic protocol. The attendees participated in two days of FHP protocol reviews, procedures, current events and training at the Landstuhl Learning Center.
"As director of FHP-IND and attending my first FHP-IND site visit, I am extremely impressed with the knowledge and professionalism provided by our staff," said Col. Isiah Harper, Medical Affairs chief and FHP director.
Harper said there has been tremendous improvement with IND support from when he was the in-patient pharmacy chief at the then 121st Evacuation Hospital in Seoul, Korea in 1985 to 1988. He was responsible for the administration, storage, and accountability of the IND product Ribavirin.
"We addressed many issues via telephone conferences but never had a team that visited us annually to check our records and to see if we were meeting FDA's requirements. It makes a difference having the experts in person to answer questions on an annual basis. This is what our customers want," said Harper.
Product managers presented FHP protocol reviews on various subjects, including, Botulinum Antitoxin for early treatment of Botulism patients; IND IV Ribavirin protocols for the treatment of Hemorrhagic Fever with Renal Syndrome and for the treatment of Crimean-Congo Hemorrhagic Fever and Lassa Fever; and post-exposure prophlaxis treatment for post exposure to anthrax spores and the treatment of Smallpox infection and vaccinia virus complications.
Dr. Janice Rusnak, FHP-IND subject matter expert, provided clinical information on the symptoms and diseases treated by FHP protocols, including a review of the recent case of a Soldier who contracted Crimean-Congo Hemorrhagic Fever while deployed in Afghanistan in support of OEF. The Soldier was air evacuated to the LRMC where he was diagnosed and treated by the LRMC and FHP team.
The issue of "Cold Chain Management and Logistics" was addressed at the meeting. It is the ability to allocate FHP products to their final destination without loss of potency.
"Cold chain management is critical in assuring that FHP products provided to the warfighters have maintained their integrity and quality," said Intisar Abbasi, FHP product manager. "The temperature is tracked from the point of shipment to the final destination and product is released for use only if temperature during shipment stayed within an approved range."
Regulatory compliance for contingency protocols, group and team building exercises were conducted by Shirley Roach, USAMMDA regulatory trainer, in order to facilitate interaction between the FHP staff and the USAMMCE and LRMC staff in Germany.
"We did several group exercises, led by Shirley, including evaluation of 'patients', played by FHP staff, to enroll into an anthrax protocol," said Marianne Erlichman, FHP product manager. "The purpose was to determine if we met inclusion/exclusion criteria for the protocol."
"The training was well received and attended by doctors, pharmacists, nurses and infection control staff from LRMC," said Lt. Col. Max Teehee, FHP deputy director. "It always turns out to be a two-way learning session, with an exchange of ideas and recommendations to make the processes work better for everyone."
Capt. Lyle Kolnik, LRMC pharmacy officer said the event was informative and gave excellent insight into current events. "[It will be] nice to apply research into pharmacy practices."
In addition to the meeting, a regulatory visit of USAMMCE and the LRMC Pharmacy Department was conducted to inspect pharmacy records and IND products.
The FHP-IND team will be travelling to Korea in November to conduct similar training with Korean staff.