Eric S. Edwards

Estimating the economic burden of food-induced allergic reactions and anaphylaxis in the United States.

BACKGROUND Food allergy is reported to affect 4% to 6% of children and 1% to 2% of adults in the United States. Every year, allergic reactions result in visits to physicians, emergency departments, and hospitals. However, the economic burden of food-induced allergic reactions is unknown. OBJECTIVE We sought to estimate the direct medical costs and indirect costs of food-induced allergic reactions and anaphylaxis in the United States. METHODS Costs were estimated with a bottom-up approach from a societal perspective: the average cost of illness per patient was calculated and multiplied by reported prevalence estimates. Patients with an inpatient admission, emergency department admission, office-based physician visit, or outpatient visit for a food-induced allergic reaction were identified from a list of federally administered 2006 and 2007 databases by using International Classification of Diseases, ninth revision, codes. Indirect costs were quantified by estimating lost productivity in terms of lost earnings caused by absenteeism and mortality of patients or caregivers. Sensitivity analyses were conducted to measure the robustness of the estimates. RESULTS For 2007, direct medical costs were

Hazards of unintentional injection of epinephrine from autoinjectors : a systematic review

225 million, and indirect costs were

Voluntarily reported unintentional injections from epinephrine auto-injectors

115 million. Office visits accounted for 52.5% of costs, and the remainder was split between emergency visits (20%), inpatient hospitalizations (11.8%), outpatient visits (3.9%), ambulance runs (3%), and epinephrine devices (8.7%). Simulations from probabilistic sensitivity analyses suggested mean direct medical costs were

Design validation and labeling comprehension study for a new epinephrine autoinjector

307 million and indirect costs were

Application of human factors engineering (HFE) to the design of a naloxone auto-injector for the treatment of opioid emergencies

203 million. CONCLUSIONS The economic burden of allergic reactions caused by food and anaphylaxis was an estimated half a billion dollars in 2007. Ambulatory visits accounted for more than half of the costs.

Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering

OBJECTIVES To ascertain the rate of occurrence of unintentional injections from epinephrine autoinjectors used in the first aid treatment of anaphylaxis and to provide information about the resulting needle stick injuries. DATA SOURCES A systematic review was performed. The MEDLINE, Scirus, CINAHL, ISI Web of Science, and Google Scholar databases were searched by title and abstract to identify reports of unintentional injections from epinephrine autoinjectors published in peer-reviewed journals. STUDY SELECTION Publications were selected for inclusion based on predefined strict criteria. RESULTS In 26 reports published during the past 20 years, we identified 69 people with an unintentional injection of epinephrine from an autoinjector. More than 68% of them were reported in the past 6.3 years, 58% were female, 42% were injured in the home, and 91% sustained injury to a finger or thumb. More than 65% of the 69 individuals were evaluated in an emergency department; 13% of the 69 were not treated or were treated only with observation. Warming of the injured part was used in 25%, nitroglycerin paste application in 9%, local injections of phentolamine and/or lidocaine in 22%, and other treatments in 20%; treatment, or lack thereof, was not described in 12%. No permanent sequelae were reported. CONCLUSIONS The true rate of occurrence of unintentional injection of epinephrine from autoinjectors is unknown but is increasing. People at risk for anaphylaxis need regular coaching in how to use epinephrine autoinjectors correctly and safely. Improved autoinjector design will address the safety concerns identified in this review.

Design of a New Epinephrine Auto-Injector to Minimize Use Errors

BACKGROUND Epinephrine auto-injectors provide life-saving prehospital treatment for individuals experiencing anaphylaxis in community settings. OBJECTIVE To determine the number, demographics, and associated circumstances and outcomes of unintentional injections from epinephrine auto-injectors. METHODS We searched the databases of the American Association of Poison Control Centers and the Food and Drug Administrations Safety Information and Adverse Event Report System for these incidents as reported by members of the public and by health care professionals. RESULTS From 1994 to 2007, a total of 15,190 unintentional injections from epinephrine auto-injectors were reported to US Poison Control Centers, 60% of them from 2003 to 2007. Those unintentionally injected had a median age of 14 years (interquartile range, 8-35), 55% were female, and 85% were injected in a home or other residence. Management was documented in only 4101 cases (27%), of whom 53% were observed without intervention, 29% were treated, 13% were neither held for observation nor treated, and 4% refused treatment. In contrast, from 1969 to 2007, only 105 unintentional injections from epinephrine auto-injectors were reported to MedWatch. Forty percent of these occurred during attempts to treat allergic reactions. Injuries resulting in permanent sequelae were rarely reported to either US Poison Control Centers or to MedWatch. CONCLUSION The number of reported unintentional injections from epinephrine auto-injectors increased annually from 1994 to 2007. To prevent these unintentional injections, improved epinephrine auto-injector design is needed, along with increased vigilance in training the trainers and in training and coaching the users, as well as efforts to increase public awareness of the role of epinephrine auto-injectors in the first-aid treatment of anaphylaxis in the community.

Take-home naloxone treatment for opioid emergencies: a comparison of routes of administration and associated delivery systems

BACKGROUND To facilitate the correct use of epinephrine autoinjectors (EAIs) by patients and caregivers, a novel EAI (Auvi-Q) was designed to help minimize use-related hazards. OBJECTIVE To support validation of Auvi-Q final design and assess whether the instructions for use in the patient information leaflet (PIL) are effective in training participants on proper use of Auvi-Q. METHODS Healthy participants, 20 adult and 20 pediatric, were assessed for their ability to complete a simulated injection by following the Auvi-Q instructions for use. Participants relied only on the contents of the PIL and other labeling features (device labeling and its instructions for use, electronic voice instructions and visual prompts). RESULTS The mean ± SD age of the adult and pediatric participants was 39.4 ± 11.6 and 10.9 ± 2.3 years, respectively. In total, 80% of adult and 35% of pediatric participants had prior experience with EAIs. All adults and 95% of pediatric participants completed a simulated injection on the first attempt; 1 pediatric participant required parental training and a second attempt. Three adult and 4 pediatric participants exhibited a noncritical issue while successfully completing the simulated injection. Most participants agreed that the injection steps were easy to follow and the PIL facilitated understanding on using Auvi-Q safely and effectively. CONCLUSION The PIL and other labeling features were effective in communicating instructions for successful use of Auvi-Q. This study provided validation support for the final design and anticipated instructions for use of Auvi-Q.

DEVICES, SYSTEMS, AND METHODS FOR MEDICAMENT DELIVERY

The increased use of opioids for chronic treatment of pain and the resulting epidemic of opioid overdoses have created a major public health challenge. Parenteral naloxone has been used since the 1970’s to treat opioid overdose. Recently, a novel naloxone auto-injector device (EVZIO, kaleo, Inc., Richmond, VA) was approved by the Food and Drug Administration. In this article, we review the Human Factors Engineering (HFE) process used in the development and testing of this novel naloxone auto-injector currently used in nonmedical settings for the emergency treatment of known or suspected opioid overdose. HFE methods were employed throughout the product development process for the naloxone auto-injector including formative and summative studies in order to optimize the auto-injector’s user interface, mitigate use-related hazards and increase reliability during an opioid emergency use scenario. HFE was also used to optimize the product’s design and user interface in order to reduce or prevent user confusion and misuse. The naloxone auto-injector went through a rigorous HFE process that included perceptual, cognitive, and physical action analysis; formative usability evaluations; use error analysis and summative design validation studies. Applying HFE resulted in the development of a product that is safe, fast, easy and predictably reliable to deliver a potentially life-saving dose of naloxone during an opioid overdose emergency. The naloxone auto-injector may be considered as a universal precaution option for at-risk patients prescribed opioids or those who are at increased risk for an opioid overdose emergency.

Medical injector with compliance tracking and monitoring

Introduction: The systematic application of human factors engineering (HFE) principles to the development of drug-device combination products, including epinephrine auto-injectors (EAIs), has the potential to improve the effectiveness and safety of drug administration. Areas covered: A PubMed search was performed to assess the role of HFE in the development of drug-device combination products. The following keywords were used in different combinations: ‘human factors engineering,’ ‘human factors,’ ‘medical products,’ ‘epinephrine/adrenaline auto-injector,’ ‘healthcare’ and ‘patient safety.’ This review provides a summary of HFE principles and their application to the development of drug-device combination products as advised by the US FDA. It also describes the HFE process that was applied to the development of Auvi-Q, a novel EAI, highlighting specific steps that occurred during the product-development program. Expert opinion: For drug-device combination products, device labeling and usability are critical and have the potential to impact clinical outcomes. Application of HFE principles to the development of drug-delivery devices has the potential to improve product quality and reliability, reduce risk and improve patient safety when applied early in the development process. Additional clinical and real-world studies will confirm whether the application of HFE has helped to develop an EAI that better meets the needs of patients at risk of anaphylaxis.