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Although we are a long way from having a designated day recognizing acute respiratory infection prevention and awareness, respiratory tract infections come second in the global burden of disease rankings after heart disease and are the second most common cause of morbidity and mortality worldwide. But, unlike heart disease, acute respiratory tract symptoms account for the vast majority of antibiotic prescriptions. Unfortunately, most of these antibiotic scripts are given empirically, without the proper medical evidence, and are thus unnecessary.   To catch up with the spread of antimicrobial resistance, awareness of this critical issue needs to spread as fast as resistance itself. The World Health Organization (WHO) recently issued the most comprehensive global report on antimicrobial resistance to date. Data provided by 114 countries confirmed that antimicrobial resistance is truly a global issue with high levels of resistance found in every region of the world. In September, President Obama signed an Executive Order directing key U.S. departments and agencies to take action to combat the rise of antibiotic-resistant bacteria. In the U.S. alone, antibiotic-resistant bacteria cause approximately 2 million infections and 23,000 deaths annually.   Antibiotic misuse   The WHO estimates that the availability of antibiotics adds an average of 20 years to all of our lives. However, in the 80 years since the discovery of penicillin, our overuse of these medications has put pressure on bacteria to evolve, leading to the emergence of untreatable superbugs that threaten the foundation of modern medicine. However, to truly combat antibiotic resistance, we need to first step back to understand antibiotic misuse and its associated issues, which span well beyond resistance.   First, in a world fractured by discrepancies in both financial resources and access to quality healthcare, the actual medication cost per treatment is one important consideration in the use of antibiotics. While the cost associated with treatment may be justified and even life saving in cases of medical necessity, the costs may be wasted in cases of unnecessary use. Estimates of the annual impact of antibiotic-resistant infections on the U.S. economy alone have ranged as high as $20 billion in excess direct healthcare costs, and as much as $35 billion in lost productivity from hospitalizations and sick days.   Further, there are many adverse events and complications associated with the use of antibiotics. With any treatment, a thoughtful decision has to be made in which the benefits have to outweigh the risks. With antibiotics, the risks of adverse events and complications are significant, including gastrointestinal distress, yeast infection in females, clostridium difficile (a potentially deadly diarrhea-causing bacteria), and allergy. Antibiotic allergies can span a spectrum of illness from life-threating complications including anaphylaxis and Steven-Johnson syndrome to causing rashes and hives that often necessitate emergency room visits, hospitalizations, and costly secondary treatments.   Lastly, antibiotic misuse leads to resistance, which occurs when a microorganism no longer responds to a therapeutic agent that was originally effective for treatment of its infection. Broadly, antimicrobial resistance threatens the prevention and treatment of an increasing range of infections caused by bacteria, parasites, viruses and fungi. Specifically, the misuse of antibiotics accelerates the development of resistant strains of bacteria. Some bacterial infections are now untreatable because the causal agents have acquired resistance to all of the antibiotics available to fight them. Without effective antibiotics, we will no longer be able to treat bacterial infections reliably and rapidly. Antibiotics are critically important for many modern medical interventions, including chemotherapy, complex surgery, and organ transplantation.   Antibiotic resistance   Although leading hospital systems are successfully implementing antimicrobial stewardship programs, these initiatives often are expensive to institute, difficult to coordinate, and represent a minority of the antibiotic prescriptions prescribed each year. Upon reaching an in-patient healthcare setting, patients are often very ill and the antibiotic resistance too pervasive. Overall, while admirable and beneficial, hospital-based antibiotic stewardship programs are reactive. To become truly impactful, change is also needed in the community-based healthcare setting. Inexpensive, rapid point-of-care diagnostic testing may provide clinicians with ability to better identify clinically significant infections and allow for more targeted therapeutic decision-making – essentially bringing antibiotic stewardship to the outpatient setting. It is often just as important to instill confidence for the clinician to pursue a delayed treatment plan, or “watchful waiting” strategy, than it is to recognize those patients requiring immediate intervention.   Detection   Clinicians empirically prescribe broad-spectrum antibiotics before accurate diagnostic information is available because of their perceived risk of misdiagnosis, both clinically and medical-legally. Optimum clinical management outcomes can be achieved only through pathogen-directed therapeutics. To realize this goal, a rapid and accurate diagnosis of the microbial cause of respiratory tract infections should be sought and appropriate patient management instituted. Despite laboratory diagnostic advances, a need for rapid, sensitive, and affordable in-office diagnostics remains. Recognizing this technology gap, the Obama Administration announced a $20 million prize to facilitate the development of rapid, point-of-care diagnostic tests for healthcare providers to identify highly resistant bacterial infections.   One strategy to combat resistance is to detect the presence of biomarkers that can aid in the identification of clinically significant infections and also to differentiate viral from bacterial etiologies – with the biomarker serving as a surrogate endpoint for the presence of an infection. In Europe, C-reactive protein (CRP) is a widely used biomarker to identify bacterial infection. For example, the United Kingdom’s National Institute of Health and Care Excellence (NICE) guidelines recommend consideration of a point-of-care CRP test for patients presenting with symptoms of lower respiratory tract infection. Further, NICE specifically recommends guiding antibiotic prescribing based on the results of the CRP test. Testing for CRP has been shown to lower antibiotic use without significantly increasing complications or adverse events. With the interest of the global community and the backing of governmental agencies, newer biomarkers and technologies are likely to further improve the clinician’s ability to confidently decide to prescribe or withhold antibiotics when faced with acute respiratory symptoms. This ability will empower the clinician to provide the most cost-effective care and thus will help preserve our precious antibiotic resources.

The views presented in this article are the author’s own and do not necessarily represent the views of any other organization.

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Point-of-Care Testing: Bringing Antibiotic Stewardship to the Outpatient Setting

macro of pills
May 18, 2015

Although we are a long way from having a designated day recognizing acute respiratory infection prevention and awareness, respiratory tract infections come second in the global burden of disease rankings after heart disease and are the second most common cause of morbidity and mortality worldwide. But, unlike heart disease, acute respiratory tract symptoms account for the vast majority of antibiotic prescriptions. Unfortunately, most of these antibiotic scripts are given empirically, without the proper medical evidence, and are thus unnecessary.   To catch up with the spread of antimicrobial resistance, awareness of this critical issue needs to spread as fast as resistance itself. The World Health Organization (WHO) recently issued the most comprehensive global report on antimicrobial resistance to date. Data provided by 114 countries confirmed that antimicrobial resistance is truly a global issue with high levels of resistance found in every region of the world. In September, President Obama signed an Executive Order directing key U.S. departments and agencies to take action to combat the rise of antibiotic-resistant bacteria. In the U.S. alone, antibiotic-resistant bacteria cause approximately 2 million infections and 23,000 deaths annually.   Antibiotic misuse   The WHO estimates that the availability of antibiotics adds an average of 20 years to all of our lives. However, in the 80 years since the discovery of penicillin, our overuse of these medications has put pressure on bacteria to evolve, leading to the emergence of untreatable superbugs that threaten the foundation of modern medicine. However, to truly combat antibiotic resistance, we need to first step back to understand antibiotic misuse and its associated issues, which span well beyond resistance.   First, in a world fractured by discrepancies in both financial resources and access to quality healthcare, the actual medication cost per treatment is one important consideration in the use of antibiotics. While the cost associated with treatment may be justified and even life saving in cases of medical necessity, the costs may be wasted in cases of unnecessary use. Estimates of the annual impact of antibiotic-resistant infections on the U.S. economy alone have ranged as high as $20 billion in excess direct healthcare costs, and as much as $35 billion in lost productivity from hospitalizations and sick days.   Further, there are many adverse events and complications associated with the use of antibiotics. With any treatment, a thoughtful decision has to be made in which the benefits have to outweigh the risks. With antibiotics, the risks of adverse events and complications are significant, including gastrointestinal distress, yeast infection in females, clostridium difficile (a potentially deadly diarrhea-causing bacteria), and allergy. Antibiotic allergies can span a spectrum of illness from life-threating complications including anaphylaxis and Steven-Johnson syndrome to causing rashes and hives that often necessitate emergency room visits, hospitalizations, and costly secondary treatments.   Lastly, antibiotic misuse leads to resistance, which occurs when a microorganism no longer responds to a therapeutic agent that was originally effective for treatment of its infection. Broadly, antimicrobial resistance threatens the prevention and treatment of an increasing range of infections caused by bacteria, parasites, viruses and fungi. Specifically, the misuse of antibiotics accelerates the development of resistant strains of bacteria. Some bacterial infections are now untreatable because the causal agents have acquired resistance to all of the antibiotics available to fight them. Without effective antibiotics, we will no longer be able to treat bacterial infections reliably and rapidly. Antibiotics are critically important for many modern medical interventions, including chemotherapy, complex surgery, and organ transplantation.   Antibiotic resistance   Although leading hospital systems are successfully implementing antimicrobial stewardship programs, these initiatives often are expensive to institute, difficult to coordinate, and represent a minority of the antibiotic prescriptions prescribed each year. Upon reaching an in-patient healthcare setting, patients are often very ill and the antibiotic resistance too pervasive. Overall, while admirable and beneficial, hospital-based antibiotic stewardship programs are reactive. To become truly impactful, change is also needed in the community-based healthcare setting. Inexpensive, rapid point-of-care diagnostic testing may provide clinicians with ability to better identify clinically significant infections and allow for more targeted therapeutic decision-making – essentially bringing antibiotic stewardship to the outpatient setting. It is often just as important to instill confidence for the clinician to pursue a delayed treatment plan, or “watchful waiting” strategy, than it is to recognize those patients requiring immediate intervention.   Detection   Clinicians empirically prescribe broad-spectrum antibiotics before accurate diagnostic information is available because of their perceived risk of misdiagnosis, both clinically and medical-legally. Optimum clinical management outcomes can be achieved only through pathogen-directed therapeutics. To realize this goal, a rapid and accurate diagnosis of the microbial cause of respiratory tract infections should be sought and appropriate patient management instituted. Despite laboratory diagnostic advances, a need for rapid, sensitive, and affordable in-office diagnostics remains. Recognizing this technology gap, the Obama Administration announced a $20 million prize to facilitate the development of rapid, point-of-care diagnostic tests for healthcare providers to identify highly resistant bacterial infections.   One strategy to combat resistance is to detect the presence of biomarkers that can aid in the identification of clinically significant infections and also to differentiate viral from bacterial etiologies – with the biomarker serving as a surrogate endpoint for the presence of an infection. In Europe, C-reactive protein (CRP) is a widely used biomarker to identify bacterial infection. For example, the United Kingdom’s National Institute of Health and Care Excellence (NICE) guidelines recommend consideration of a point-of-care CRP test for patients presenting with symptoms of lower respiratory tract infection. Further, NICE specifically recommends guiding antibiotic prescribing based on the results of the CRP test. Testing for CRP has been shown to lower antibiotic use without significantly increasing complications or adverse events. With the interest of the global community and the backing of governmental agencies, newer biomarkers and technologies are likely to further improve the clinician’s ability to confidently decide to prescribe or withhold antibiotics when faced with acute respiratory symptoms. This ability will empower the clinician to provide the most cost-effective care and thus will help preserve our precious antibiotic resources.

The views presented in this article are the author’s own and do not necessarily represent the views of any other organization.