Medical Aspects of Chemical Warfare (2008) - The Black Vault

Medical Aspects of Chemical Warfarewhere protective suits and masks are not required.MANAA was intended to allow a medic to supervisea group of casualties who were capable of assistingwith their own care. Theoretically, MANAA could freeup medical personnel to treat more severely poisonedor injured casualties in a mass casualty situation. Noother aerosolized treatment for nerve agent poisoninghas been licensed by the FDA. MANAA was approvedby the FDA in 1990.MANAA is approaching the end of its shelf life.The manufacturer no longer maintains the cGMPmanufacturing line required to produce MANAA.Under the Montreal Protocol, an international treatycreated to phase out ozone-depleting substances,aerosolized products such as MANAA must be discontinuedbecause they contain chlorofluorocarbons.A congressionally-funded program for a dry powderinhaler atropine (DPIA) seeks to develop a product thatwill replace the MANAA. DPIA is being developedjointly by a team that includes MicroDose Technologies,Inc, the University of Pittsburgh, and the MITSJPMO. DPIA is anticipated to be FDA approved in 2009,with fielding anticipated the following year.ATNAA is a product developed to replace andimprove upon the Mark I. It is a dual-chambered autoinjectorthat delivers 2.1 mg atropine (as comparedto the 2 mg atropine in the Mark I) and 600 mg 2-PAMCl through a single needle. ATNAA was approved bythe FDA in January 2002 and fielding began in 2003.ATNAA delivers antidotes faster than Mark I becauseit uses a single autoinjector rather than two, cutting thetime needed to administer life-saving treatment to anerve agent casualty in half. ATNAA is also smaller,easier to use, and less expensive than the Mark I.Sustainment ProgramsOther products carry FDA approval but requirePhase 4 (post-marketing) studies as mandated by theFDA. For example, the Skin Exposure Reduction PasteAgainst Chemical Warfare Agents (SERPACWA; FisherBioservices, Rockville, Md) is a perfluorohydrocarbonbasedbarrier cream intended to pretreat vulnerableskin areas (such as the groin, neck, wrists, armpits,waistline, and boot tops) prior to donning protectiveovergarments. SERPACWA provides a passive barrierthat protects the skin from liquid chemical agentexposure for over 8 hours. While SERPACWA is meantto be used in conjunction with mission-oriented protectiveposture, some Special Forces units have inquiredabout its use without full mission-oriented protectiveposture protection. The FDA approved SERPACWA inFebruary 2000 and the US Army has purchased initialquantities. SERPACWA also protects against manynatural toxins as well, including poison ivy, suggestinga possible use in civilian medicine. However, SER-PACWA is currently only approved for military use.Studies are ongoing to determine the compatibilityof SERPACWA with the M291 skin decontaminationkit, a pouch containing six individual decontaminationpackets that can provide a total of three completeskin decontaminations. SERPACWA currently has anFDA-approved, 3-year shelf life, and is included in theFDA/DoD shelf life extension program.Another FDA-approved product awaiting Phase 4trials is soman nerve agent pretreatment pyridostigmine,which is distributed as 30 mg pyridostigminebromide tablets. In February 2003, this pretreatmentbecame the first drug to be approved by the FDA viathe animal rule.The FDA has mandated the following post-marketingstudies for this product:• a human serum study to correlate dose responsebetween pyridostigmine bromideblood levels and red cell acetylcholinesteraseinhibition;• a guinea pig study to correlate blood pyridostigminebromide levels, red cell acetylcholinesteraseinhibition, tissue acetylcholinesteraseinhibition, and the direct effects uponthe diaphragm;• a nonhuman primate study to look at the samequestions as in the guinea pig; and• an in vitro human intercostal muscle study todetermine if pretreatment can provide partialprotection to soman exposure of the muscle.The first two studies are complete, the remainingstudies are ongoing.Products in Advanced DevelopmentThe joint service personnel/skin decontaminationsystem (JSPDS) program is tasked with developing animproved skin decontamination capability throughopen competition between commercially availableproducts. The current skin decontamination kit, M291,which has been fielded since 1989, is based on theAmbergard resin (Rohm and Haas, LLC, Philadelphia,Pa) that adsorbs and slowly detoxifies chemical agents.The JSPDS program is under the purview of the JointProject Management Office for Decontamination, withmedical consultation from MITS JPMO. The JointProject Management Office for Decontamination competitivelychose Reactive Skin Decontamination Lotion(RSDL; E-Z-EM, Inc, Lake Success, NY), developed bythe Canadian Department of National Defence under652