ATNAA: Difference between revisions
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== FDA approval == |
== FDA approval == |
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During initial trials and submission to the FDA for approval, the [[United States Department of Defense]] requested that the [[United States Food and Drug Administration|FDA]] waive the requirement for a doctor's prescription for the ATNAA device; the rationale being that it would be issued [[en masse]] to troops. The waiver request was denied.<ref>Pg 59, Bio Pharm PDF document: http://www.fda.gov/cder/foi/nda/2002/21175_Atnaa_biopharmr.pdf</ref> |
During initial trials and submission to the FDA for approval, the [[United States Department of Defense]] requested that the [[United States Food and Drug Administration|FDA]] waive the requirement for a doctor's prescription for the ATNAA device; the rationale being that it would be issued [[en masse]] to troops. The waiver request was denied.<ref>Pg 59, Bio Pharm PDF document: {{cite web|url=http://www.fda.gov/cder/foi/nda/2002/21175_Atnaa_biopharmr.pdf |title=Archived copy |accessdate=2009-05-13 |deadurl=yes |archiveurl=https://web.archive.org/web/20081022205733/http://www.fda.gov/cder/foi/nda/2002/21175_Atnaa_biopharmr.pdf |archivedate=2008-10-22 |df= }}</ref> |
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== Training == |
== Training == |
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Revision as of 11:23, 1 October 2016
An ATNAA (Antidote Treatment Nerve agent autoinjector) is any of a variety of autoinjectors in use with the US Armed Forces. An autoinjector (or auto-injector) is a medical device designed to deliver a single dose of a particular (typically life-saving) drug.
Most autoinjectors are spring-loaded syringes. By design, autoinjectors are easy to use and are intended for self-administration by patients. The site of injection depends on the drug loaded, but it typically is administered into the thigh or the buttocks. The injectors were initially designed to overcome the hesitation associated with self-administration of the needle-based drug delivery device. It is the newer delivery vehicle to be used in lieu of the Mark I NAAK.
Purpose
The ATNAA provides Atropine and Pralidoxime chloride in a single delivery system although the two drugs are separate within the device.[1] The use of the device is only to be administered in the extreme case of organophosphate poisoning. The delivery system is designed for use by military personnel only, and is only issued to DOD personnel that are considered to be in immediate danger of a chemical attack or work in a position (such as ordnance disposal) where there is a high likelihood of nerve agent exposure.[2]
FDA approval
During initial trials and submission to the FDA for approval, the United States Department of Defense requested that the FDA waive the requirement for a doctor's prescription for the ATNAA device; the rationale being that it would be issued en masse to troops. The waiver request was denied.[3]
Training
As a condition of approval, the FDA lists on the device label the precise instructions that are to be given to military personnel on dosage and administration.[4] While each branch of the DoD typically provides their own tailored training, an example of the MK I NAAK and ATNAA are referenced in the United States Air Force Self Aid Buddy Care Training (SABC). SABC encompasses basic life support and limb-saving techniques to help wounded or injured personnel survive in medical emergencies until medical help is available.[5]
References
- ^ ATNAA Factsheet: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf
- ^ FDA approval process http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa.cfm
- ^ Pg 59, Bio Pharm PDF document: "Archived copy" (PDF). Archived from the original (PDF) on 2008-10-22. Retrieved 2009-05-13.
{{cite web}}: Unknown parameter|deadurl=ignored (|url-status=suggested) (help)CS1 maint: archived copy as title (link) - ^ See DOSAGE AND ADMINISTRATION within ATNAA Factsheet: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21175_Atnaa_prntlbl.pdf
- ^ see Training Objectives AFI 36-2238, SABC Training:http://www.e-publishing.af.mil/shared/media/epubs/AFI36-2238.pdf
Further reading
- Meridian Meds: http://www.meridianmeds.com/pdf/ATNAA_Pack_Insert.pdf
- Landauer, W: Cholinomimetic teratogens. V. The effect of oximes and related cholinesterase reactivators. Teratology 15: 33 (Feb) 1977.
- Moller, K.O., Jensen-Holm, J. and Lausen, H.H.: Ugeskrift for Læger. 123: 501,1961.
- Namba, T., Nolte, C.T., Jackrel, J. and Grob, D.: Poisoning due to organophosphate insecticides. Acute and chronic manifestations. Amer. J. Med. 50: 475 (Apr), 1971.
- Arena, J.M.: Poisoning, Toxicology Symptoms, Treatments, ed. 4, Springfield, IL, Charles C. Thomas, 1979, p. 133.
- Brachfeld, J., and Zavon, M.R.: Organic phosphate (Phosdrin) intoxication. Report of a case and the results of treatment with 2-PAM, Arch. Environ. Health 11: 859, 1965.
- Hayes, W.J., Jr.: Toxicology of Pesticides. Baltimore, The Williams & Wilkins Company, 1975, p. 416.