Chapter SC1: Principles of Antidote Stocking

INTRODUCTION

Most patients with xenobiotic exposures do well with supportive care and close attention to vital physiology. However, one of the fundamental principles of managing an acutely poisoned patient is appropriate and timely antidotal administration when indicated. According to the last available US Poison Control Center data, a therapeutic intervention which includes specific antidotes was used in 18.5% of all poisoning exposures (Chap. 130).^16,41

Sufficient antidote stocking is a best practice; failure to do so presents a clear and present danger to patient safety. Death and serious harm resulted from the delay to administer appropriate antidotes, reversal agents, and rescue agents.²⁸ Many poisonings are acute unanticipated emergencies, which would presumably invoke the protections of the Emergency Medical Treatment and Labor Act of 1986, which mandates public access to emergency services regardless of ability to pay. The Joint Commission (TJC) is the accrediting body for hospitals. The Joint Commission’s elements of performance require that “emergency medications and their associated supplies are readily available,” as well as written criteria determining which medications are available for dispensing or administering to patients.^55,56 The Joint Commission also recognizes the difficulties presented by medication shortages and requires staff communication, written medication substitution protocols approved by leadership and the medical staff, and review of the impact of substitutions (eg, medication errors and adverse drug events).⁵⁷ It is an Institute for Safe Medication Practices best practice to “ensure all appropriate antidotes, reversal agents, and rescue agents are readily available.”²⁸ The World Health Organization devotes an entire section to antidotes and other substances used in poisonings that are considered of paramount importance in its model list of essential medicines.⁶⁵ Because many antidotes are used in practice to reverse potential medication errors, overdoses, or adverse clinical conditions, the Department of Veterans Affairs (VA) National Center for Patient Safety considers it mandatory that reversal agents such as flumazenil, naloxone, protamine, and others are available in the clinical setting.⁶⁰ Antidotes are a fundamental aspect of response (as medical countermeasures) to chemical, biological, and radiologic terrorism. As such, provisioning and antidotal administration are Critical Target Capabilities in the US National Preparedness Guidelines.⁵⁹ These national Preparedness Measures include quarterly updates to the federal government on the status of critical items; memoranda of understanding to determine collective inventory accessibility and to ramp up manufacturing capability; and maintenance by pharmaceutical manufacturers and distributors of increased inventory amounts of critical items.⁵⁹ Many professional organizations such as the American Heart Association, American Hospital Association, American Medical Association, American College of Medical Toxicology, and American Academy of Clinical Toxicology consider drug and antidote shortages a significant threat to public health and patient outcomes.^5,6,8,9

LOCAL AVAILABILITY

Decades of research have consistently documented inadequate stocking of antidotes, which are required at critical instances. In 1986, the lack of any antidotal ...