Expert Consensus Guidelines for Stocking of Antidotes in Hospitals That Provide Emergency Care
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TOXICOLOGY/CONCEPTS Expert Consensus Guidelines for Stocking of Antidotes in Hospitals That Provide Emergency Care Richard C. Dart, MD, PhD From the Rocky Mountain Poison & Drug Center - Denver Health, Denver, CO (Dart, Heard, Schaeffer, Stephen W. Borron, MD, MS Bogdan, Alhelail, Buchanan, Hoppe, Lavonas, Mlynarchek, Phua, Rhyee, Varney, Zosel); Department of E. Martin Caravati, MD, MPH Surgery, University of Texas Health Sciences Center, San Antonio, TX (Borron); Division of Emergency Daniel J. Cobaugh, PharmD Medicine, Utah Poison Control Center, University of Utah Health Sciences Center, Salt Lake City, UT Steven C. Curry, MD (Caravati); ASHP Research and Education Foundation, Bethesda, MD (Cobaugh); Department of Jay L. Falk, MD Medical Toxicology and Banner Poison Control Center, Banner Good Samaritan Medical Center, Lewis Goldfrank, MD Phoenix, AZ (Curry); Department of Emergency Medicine, Orlando Regional Medical Center, University of Susan E. Gorman, PharmD, MS Florida, Orlando, FL (Falk); New York City Poison Center; New York University School of Medicine, New Stephen Groft, PharmD York, NY (Goldfrank); Division of Strategic National Stockpile, Centers for Disease Control and Kennon Heard, MD Prevention, Atlanta, GA (Gorman); Office of Rare Diseases Research, Bethesda, MD (Groft); Division of Ken Miller, MD, PhD Emergency Medicine, School of Medicine (Dart, Heard, Lavonas, Schaeffer) and Department of Kent R. Olson, MD Pharmaceutical Sciences, School of Pharmacy (Bogdan), University of Colorado Denver, Aurora, CO; Gerald O’Malley, DO Orange County Fire Authority and Orange County Health Care Agency Emergency Medical Services, Donna Seger, MD Irvine, CA, and National Association of EMS Physicians, Lenexa, KS, (Miller); University of California, Steven A. Seifert, MD San Francisco, and San Francisco Division, California Poison Control System, San Francisco, CA Marco L. A. Sivilotti, MSc, MD (Olson); Division of Research, Department of Emergency Medicine, Albert Einstein Medical Center, Tammi Schaeffer, DO Philadelphia, PA (O’Malley); Tennessee Poison Center, Division of Clinical Pharmacology, Department of Anthony J. Tomassoni, MD, MS Medicine, Vanderbilt University Medical Center, Nashville, TN (Seger); University of New Mexico School Robert Wise, MD of Medicine & Medical Director, New Mexico Poison and Drug Information Center, Albuquerque, NM Gregory M. Bogdan, PhD (Seifert); Department of Emergency Medicine and Department of Pharmacology & Toxicology, Queen’s Mohammed Alhelail, MD University, Ontario, Canada (Sivilotti); Yale University School of Medicine, Department of Surgery, Jennie Buchanan, MD Section of Emergency Medicine, and Yale-New Haven Center for Emergency Preparedness and Disaster Jason Hoppe, DO Response, New Haven, CT (Tomassoni); Division of Standards and Survey Methods, The Joint Eric Lavonas, MD Commission, Oakbrook Terrace, IL (Wise). Sara Mlynarchek, MPH Dong-Haur Phua, MD Sean Rhyee, MD, MPH Shawn Varney, MD Amy Zosel, MD For the Antidote Summit Authorship Group Study objective: We developed recommendations for antidote stocking at hospitals that provide emergency care. Methods: An expert panel representing diverse perspectives (clinical pharmacology, clinical toxicology, critical care medicine, clinical pharmacy, emergency medicine, internal medicine, pediatrics, poison centers, pulmonary medicine, and hospital accreditation) was formed to create recommendations for antidote stocking. Using a standardized summary of the medical literature, the primary reviewer for each antidote proposed guidelines for antidote stocking to the full panel. The panel used a formal iterative process to reach their recommendation for the quantity of an antidote that should be stocked and the acceptable period for delivery of each antidote. Results: The panel recommended consideration of 24 antidotes for stocking. The panel recommended that 12 of the antidotes be available for immediate administration on patient arrival. In most hospitals, this period requires that the antidote be stocked in the emergency department. Another 9 antidotes were recommended for availability within 1 hour of the decision to administer, allowing the antidote to be stocked in the hospital pharmacy if the hospital has a mechanism for prompt delivery of antidotes. The panel identified additional antidotes that should be stocked by the hospital but are not usually needed within the first hour of treatment. The panel recommended that each hospital perform a formal antidote hazard vulnerability assessment to determine the need for antidote stocking in that hospital. Conclusion: The antidote expert recommendations provide a tool to be used in creating practices for appropriate and adequate antidote stocking in hospitals that provide emergency care. [Ann Emerg Med. 2009;54:386-394.] 0196-0644/$-see front matter Copyright © 2009 by the American College of Emergency Physicians. doi:10.1016/j.annemergmed.2009.01.023 386 Annals of Emergency Medicine Volume , . : September guide.medlive.cn Dart et al Antidote Stocking Guidelines INTRODUCTION relevant guidelines despite an evidence base that is incomplete, Antidotes are a critical component in the care of poisoned we combined a structured analysis of the existing literature with patients. Antidotes such as digoxin immune Fab can be an expert consensus panel. lifesaving; however, an antidote must be available at the appropriate time to be effective. For some poisons, the antidote MATERIALS AND METHODS must be available immediately. The administration of cyanide Overview antidote can resuscitate a patient only if the antidote is Recommendations for antidote stocking were created in 2 administered before irreversible injury develops. For other phases similar to the development of American College of antidotes, there is time to procure the drug from the pharmacy Emergency Physicians (ACEP) clinical policies. First, or from another hospital. The use of a specific antidote was standardized evidence-based summaries of the medical literature reported by US poison centers approximately 80,000 times in were generated for each antidote. Each summary was then 2006.1 Unfortunately, important antidotes often are not independently reviewed and revised by a primary reviewer from stocked at all or are stocked in an insufficient amount. the expert panel. The reviewer presented the summary and the Insufficient stocking of a diverse group of antidotes has been recommendation to the full panel, and an iterative process was documented repeatedly in many countries, including the United used to reach consensus. The panel was instructed to address States and Canada.2-9 specifically the needs of hospitals that provide emergency care in Although national recommendations of an expert panel were the United States. Stocking of antidotes for mass casualty events published in 2000, reports of inadequate stocking persist.10,11 was not addressed by the panel. Details about administration of The causes of this serious problem are unknown but are likely each antidote were not addressed by the panel. related in part to limited awareness, infrequent use, interruptions in supply, and allocation of limited hospital Phase 1 pharmacy resources. Previous studies have found that larger Relevant medical literature was obtained by nonmedical staff hospitals are more likely than smaller or rural hospitals to stock with extensive experience in searching and retrieving medical 4,7 antidotes adequately. Perceived cost of antidotes based on literature. Evidence-based summaries of the medical literature purchase price, as well as pharmacist and physician unfamiliarity for each antidote were created by a group of emergency 4,12 with poisons and their antidotes, may also contribute. physicians and clinical toxicologists not involved in the Changes in the types of antidotes available may also play a role. consensus process. For each antidote, a standardized summary In recent years, new antidotes have become available and others of 5 to 20 pages was created for subsequent assessment by the have been discontinued. primary reviewer. Publications used to create the summary were The Joint Commission (TJC) sets standards for accreditation identified with 3 methods: (1) searches for each antidote and its of hospitals in the United States but does not explicitly address indications, using the National Library of Medicine’s PubMed antidote stocking. TJC standard MM.2.10 states simply that database (http://www.pubmed.gov); limited to “human” and medications available for dispensing or administration be “English” for article types “clinical trials,” “reviews,” or “case selected, listed, and procured according to criteria. Standard reports”; (2) review of chapter bibliographies for each antidote MM.2.30 states that emergency medications or supplies, if any, in 2 textbooks of toxicology15,16; and (3) review of be consistently available, controlled, and secured.13 Individual bibliographies of selected articles from the previous 2 methods state governments also regulate hospitals, although their for additional citations. Each article was classified according to attention in terms of antidotes has primarily been focused on its methodology, using the clinical guideline model of the mass casualty and terrorist events. However, California recently ACEP (class I: good-quality randomized and blinded clinical sanctioned a hospital for violating a regulation requiring trials and good-quality systematic reviews of good-quality “. .availability of prescribed medications 24 hours