Research published in the August 2009 issue of the Journal of Emergency Medicine found the use of auto-injectors shortens the response time for administering antidotes to organophosphorous poisoning. The Saint Louis University (SLU) study (http://www.jem-journal.com/article/S0736-4679(08)00041-3/abstract) found that a single-needled, dual-chambered auto-injector containing both atropine and pralidoxime chloride—called Antidote Treatment Nerve Agent Auto-Injector (ATNAA)—can actually cut the administration time in half when compared with a single injection using a needle and syringe or two auto-injectors using the Mark I™ Nerve Agent Antidote Kit (atropine injection and pralidoxime chloride injection). The study also found there was no difference in time to administer the Mark I Kit versus one injection with traditional needle and syringe.1
The ATNAA is the U.S. military’s version of the DuoDote Auto-Injector (atropine and pralidoxime chloride injection), both manufactured by Meridian Medical Technologies™, Inc., a wholly owned subsidiary of King Pharmaceuticals®, Inc. The DuoDote Auto-Injector is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorous insecticides,2 and is approved by the U.S. Food and Drug Administration for use by emergency medical services (EMS) personnel.3
The above-mentioned randomized, unblinded study was conducted at the Saint Louis University School of Public Health’s Institute for Biosecurity and was intended to quantify and compare the time required to administer organophosphorous antidotes using traditional equipment versus auto-injectors in two different treatment conditions (either with or without wearing personal protective equipment). Investigators concluded that theuse of ATNAA auto-injectors shortens response time for administering organophosphorous antidote treatment. An ATNAA can be administered in less than half the time it takes to administer a single injection using a needle and syringe or two auto-injectors using a Mark I Kit. Since participants only administered one injection (atropine) with traditional needle and syringe, investigators concluded that the recorded times would have been at least twice as long if two injections (both atropine and pralidoxime chloride) were administered in the same manner.1
“Speed is essential when responding to an organophosphorous poisoning incident, whether it be accidental through exposure to certain insecticides or the intentional release via chemical weapon. The preferred treatment protocol involves the immediate injection of antidotes, followed by evacuation, decontamination and transportation to the hospital,” said Will Chapleau, EMT-P, RN, chairman, Prehospital Trauma Life Support, National Association of Emergency Medical Technicians. “Antidotes need to be readily accessible to EMS providers and easy to use in the field. First responders will have only minutes to administer antidotes to victims exhibiting symptoms. This study demonstrates these auto-injectors meet this need.”
This study was partially funded by a grant from Meridian Medical Technologies, Inc., the manufacturer of DuoDote, ATNAA and the Mark I Kit. DuoDote has replaced the Mark I Kit, and is accessible through federal homeland security and emergency preparedness grants.
“We obviously are pleased with the results of the SLU study,” said Tom Handel, senior vice president of Commercial Pharmaceuticals for Meridian Medical Technologies, Inc. “We are hopeful that these data will further validate DuoDote as a significant advancement in chemical preparedness technology.”
About “Organophosphate Antidote Auto-Injectors Vs. Traditional Administration: A Time Motion Study”
The fifty-six participants who completed the study were assigned to one of three groups: traditional needle/syringe (N=18), Mark I Kit (N=20) and ATNAA (N=18). Participants administered the injections into an injection trainer. Injection episodes were videotaped and the data transferred to a DVD from which a video-viewing software clock was used to time the duration of the simulated treatment administrations. Injection time (in seconds) for each injection device were as follows: ATNAA (Mean 16.9 ± 8.7; range 5 – 41); Mark I Kit (Mean 27.1 ± 6.9; range 13 – 43); traditional needle/syringe of a single injection (Mean 31.2 ± 7.6; range 18 – 51). The ATNAA required significantly less time to administer than the Mark I Kit or the traditional needle/syringe devices (P=.001). Following successful injection, participants also completed a 14-item survey containing demographic questions, perceived ease of injection, perceived importance of training, receipt of prior training and preferred training format for organophosphorous treatment. Approximately half of the participants (N=29, 51.8%) were emergency medical technicians; the remainder were healthcare providers such as nurses or physicians.1
About Chemical Nerve Agent Poisoning
When introduced into the body, chemical nerve agents (and organophosphorous insecticides) bind to enzymes (primarily acetylcholinesterase, or AChE) blocking their activity and causing an excess build up of acetylcholine (ACh), a neurotransmitter in the body that stimulates nerve pathways.4
This affects respiratory, gastrointestinal and vascular function, as well as muscle movement. In the event of a chemical nerve agent attack, individuals who have been poisoned may have only minutes to receive treatment, depending upon the route and concentration of exposure. If left untreated, muscle paralysis, combined with the build up of mucus in the respiratory tract, can lead to suffocation and death.4,5
Atropine competes with the excess ACh, blocking its effect by reducing secretions in the mouth and respiratory passages, relieving airway constriction and eventually increasing heart rate. Meanwhile, the pralidoxime chloride reactivates AChE, allowing it to resume its function of moderating the activity of ACh; this results in relieving respiratory muscle paralysis and, to some degree, reducing muscle weakness throughout the body.2
About DuoDote
Indication
DuoDote® Auto-Injector (atropine and pralidoxime chloride injection) is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.
DuoDote® Auto-Injector should be administered by emergency medical services personnel who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication. DuoDote® Auto-Injector is intended as an initial treatment of the symptoms of organophosphorous insecticide or nerve agent poisoning; definitive medical care should be sought immediately.
Important Safety Information
Individuals should not rely solely upon agents such as atropine and pralidoxime to provide complete protection from chemical nerve agents and insecticide poisoning. Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use. Evacuation and decontamination procedures should be undertaken as soon as possible. Medical personnel assisting evacuated victims of nerve agent poisoning should avoid contaminating themselves by exposure to the victim’s clothing.
In the presence of life-threatening poisoning by organophosphorous nerve agents or insecticides, there are no absolute contraindications to the use of DuoDote® Auto-Injector. When symptoms of poisoning are not severe, DuoDote® Auto-Injector should be used with extreme caution in people with heart disease, arrhythmias, recent myocardial infarction, severe narrow angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal insufficiency, chronic pulmonary disease, or hypersensitivity to any component of the product. Elderly people and children may be more susceptible to the effects of atropine. DuoDote® Auto-Injector is Pregnancy Category C and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Safety and effectiveness in children have not been established.
Muscle tightness and sometimes pain may occur at the injection site. The most common side effects of atropine can be attributed to its antimuscarinic action. Pralidoxime chloride can cause changes in vision, dizziness, headache, drowsiness, nausea, tachycardia, increased blood pressure, muscular weakness, dry mouth, emesis, rash, dry skin, hyperventilation, decreased renal function, excitement, manic behavior, and transient elevation of liver enzymes and creatine phosphokinase. When atropine and pralidoxime are used together, the signs of atropinization may occur earlier than might be expected when atropine is used alone.
The DuoDote Auto-Injector is the latest advancement at Meridian Medical Technologies in chemical nerve agent antidote technology—a single-needled, pre-filled, dual-chambered auto-injector containing two separate chemical nerve agent antidotes widely known and trusted by the medical community and clinically accepted worldwide—atropine and pralidoxime chloride. DuoDote delivers 2.1 mg/0.7 mL of atropine and 600 mg/2 mL of pralidoxime chloride, two separate chemical nerve agent antidotes, in one unit.The auto-injector is designed to be a compact, quick, efficient and reliable antidote delivery system. The DuoDote Auto-Injector can inject through clothing. The auto-injector requires no preparation prior to use, and the technology is proven.2
DuoDote was approved by the U.S. Food and Drug Administration for use by EMS personnel in late 2006.3
For more information, please visit www.DuoDote.com.
About AtroPen
Indication
AtroPen® Auto-Injector (atropine injection) is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides. Pralidoxime chloride may serve as an important adjunct to atropine therapy.
Important Safety Information
AtroPen Auto-Injector is intended as an initial treatment of the muscarinic symptoms of insecticides or nerve agent poisonings; definitive medical care should be sought immediately. AtroPen Auto-Injector should be administered by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication.
Individuals should not rely solely upon agents such as atropine and pralidoxime to provide complete protection from chemical nerve agents and insecticide poisoning. Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use. Evacuation and decontamination procedures should be undertaken as soon as possible. Medical personnel assisting evacuated victims of nerve agent poisoning should avoid contaminating themselves by exposure to the victim’s clothing.
In the presence of life-threatening poisoning by organophosphorus nerve agents and insecticides, there are no absolute contraindications to the use of AtroPen Auto-Injector. When symptoms of poisoning are less severe AtroPen Auto-Injector should be used with extreme caution in people with arrhythmias, recent myocardial infarction, severe narrow angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal insufficiency, or hypersensitivity to any component of the product. Giving additional injections in the absence of actual nerve agent or insecticide poisoning may cause an overdose of atropine which could result in temporary incapacitation and patients with cardiac disease may be at risk for serious adverse events, including death. AtroPen Auto-Injector is Pregnancy Category C and should be administered to a pregnant woman only if clearly needed.
Mild to moderate pain may be experienced at the site of injection. The major and most common side effects of atropine can be attributed to its antimuscarinic action and may occur earlier when used with pralidoxime.
Please see accompanying full Prescribing Information.
About Pralidoxime Chloride
Indication
Pralidoxime chloride injection (auto-injector) is specifically indicated for intramuscular use as an adjunct to atropine in the treatment of poisoning by nerve agents having anticholinesterase activity.
Important Safety Information
The pralidoxime chloride in the auto-injector is intended as an initial treatment of the symptoms of nerve agent poisonings; definitive medical care should be sought immediately. The pralidoxime chloride in the auto-injector should be administered by persons who have had adequate training in the recognition and treatment of nerve agent intoxication.
Individuals should not rely solely upon agents such as atropine and pralidoxime chloride to provide complete protection from chemical nerve agents and insecticide poisoning. Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use. Evacuation and decontamination procedures should be undertaken as soon as possible. Medical personnel assisting evacuated victims of nerve agent poisoning should avoid contaminating themselves by exposure to the victim’s clothing.
The pralidoxime chloride auto-injector is contraindicated in the patients who are hypersensitive to any component of the product. Pralidoxime chloride is not effective in the treatment of poisoning due to phosphorus, inorganic phosphates or organophosphates not having anticholinesterase activity. Pralidoxime chloride is Pregnancy Category C and should be administered to a pregnant woman only if clearly needed. Safety and effectiveness in children have not been established.
Mild to moderate pain may be experienced at the site of injection. Pralidoxime chloride may cause changes in vision, dizziness, headache, drowsiness, nausea, tachycardia, increased blood pressure, hyperventilation, muscular weakness, and transient elevation of liver enzymes and creatine phosphokinase. When atropine and pralidoxime chloride are used together, the signs of atropinization may occur earlier.
Please see accompanying full Prescribing Information.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company’s focus in specialty-driven markets, particularly neuroscience and hospital. King’s wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacture and marketing of pharmaceutical products for food producing animals.
