DIAZEPAM AUTO-INJECTOR

File: aaavo_01.txt
Page: 01
Total Pages: 1
SUBJECT:  DIAZEPAM AUTO-INJECTOR

			INFORMATION PAPER
								SGPS-PSP
								15 AUGUST 1990

SUBJECT:  Diazapam Autoinjector

1. Purpose. To inform Army Surgeon General of Air Force intent to obtain
Army support for procuring diazepam autoinjectors.

2. Facts.

a. The Air Force Tactical Command Surgeon has asked the Air Force
Surgeon General to assist in getting the Army Surgeon General's support for
mass procurement of diazepam autoinjectors.  Army TSG support is required
because the Army holds the Investigational New Drug (IND) application for the 
product.

b.  This Investigational product is known as conversant antidote for
nerve agent(CANA) and is under study by the USAMRDC to treat nerve agent
casualties unresponsive to 3 doses of Atropine + 2-Pam Chloride.

c. The FDA must approve the Army's proposal to mass produce and issue
this product.  In view of national crisis, FDA appears to support the use of
this product for military use.  Their General Counsel is reviewing the 
proposal.

d.  Pending approval of Army TSG and FDA's General Counsel, USAMMDA will
contract for production of the autoinjectors.

e.  If manufactured under urgent circumstance, the autoinjector "blank"
to be filled with diazepam,  will be the identical type used to make the  2-Pam
Chloride autoinjector.  Theoretically, in the dark, these two could be
mixed-up, but there are practical ways to avoid that problem.  The
autoinjector prototype under study has a phalange along its side which helps
to distinguish it from 2-Pam chloride but there is no way to quickly mass
produce this prototype.

f.  The Air Force and Navy want to procure this product ASAP and are
currently submitting their requirements to USAMMDA.  Initial input is Air
Force 30,000 autoinjectors and Navy 45,000 autoinjectors.  Army requirements
are estimated to be 83,000 autoinjectors.  It is estimated that the
manufacturer can provide 30,000 units within four weeks.

g.  Unit issue is 1 per soldier and 4 additional per unit aidman and
combat lifesaver.  Current Army doctrine is to administer diazepam by needle
and syringe. Soldiers are more familiar with autoinjectors:  they can be used
by their "buddy", and they are easier to use while wearing MOPP gear than
needle and syringe.

h.   COL Dunn, the Chemical Casualty Care Consultant, supports this
initiative and recommends Army TSG approve production and fielding of this
autoinjector for the three Services as long as the requirements for informed
consent normally required under IND protocol be waived as in the current case
with pyridostigmine.

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