Critical Care Commentary Conscience Rights, Medical Training, and Critical Care Editor’s Note:

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Tue, 10/23/2018 - 16:10
A Medical Student Perspective

 

When I invited Dr. Wes Ely – the coauthor of a recent article regarding physician-assisted suicide – to write a Critical Care Commentary on said topic, an interesting thing happened: he declined and suggested that I invite a group of students from medical schools across the country to write the piece instead. The idea was brilliant, and the resulting piece was so insightful that the CHEST® journal editorial leadership suggested submission to the journal, and the accepted article will appear in the September issue. Out of that effort, the idea for the present piece was born. The result is an opportunity to hear the students’ voices, not only to stimulate discussion on conscientious objection in medicine but also to remind the ICU community that our learners have their own opinions and that through dialogues such as this, we might all learn from one another.

Lee Morrow, MD, FCCP

“No provision in our Constitution ought to be dearer to man than that which protects the rights of conscience against the enterprises of the civil authority.” – Thomas Jefferson

(Washington HA. The Writings of Thomas Jefferson. New York: Biker, Thorne, & Co. 1854,; Vol 3:147.)

What is the proper role of conscience in medicine? A recent article in the New England Journal of Medicine (Stahl & Emmanuel. N Engl J Med. 2017; 376(14):1380) is the latest to address this question. It is often argued that physicians who cite conscience in refusing to perform requested procedures or treatments necessarily infringe upon patients’ rights. However, we feel that these concerns stem from a fundamental misunderstanding of what conscience is, why it ought to be respected as an indispensable part of medical judgment (Genuis & Lipp . Int J Family Med. 2013; Epub 2013 Dec 12), and how conscience is oriented toward the end goal of health, which we pursue in medicine.

By failing to define “conscience,” the crux of the argument against conscience rights is built on the basis of an implied diminution of conscience from an imperative moral judgment down to mere personal preference. If conscience represents only personal preference – if it is limited to a set of choices of the same moral equivalent as the selection of an ice cream flavor, with no need for technical expertise—then it would follow that a physician ought to simply comply with the patient’s decisions in any given medical situation. However, we know intuitively that this line of reasoning cannot hold, if followed to its conclusion. For example, if a patient presenting with symptoms of clear rhinorrhea and dry cough in December asks for an antibiotic, through this patient-sovereignty model, the physician surely ought to provide the prescription to honor the patient’s request. The patient would have every right to insist on the antibiotic, and the physician would be obliged to prescribe accordingly. We, as students, are trained, however, that it would be morally and professionally fitting, even obligatory, for the physician to refuse this request, precisely through exercise of his/her professional conscience.

If conscience, then, is not simply a subject of one’s personal preferences, how are we to properly understand it? Conscience is “a person’s moral sense of right and wrong, viewed as acting as a guide to one’s behavior” (Conscience. Oxford Dictionary. Oxford, Oxford University Press. 2017). It exhibits the commitment to engage in a “self-conscience activity, integrating reason, emotion, and will, in self-committed decisions about right and wrong, good and evil” (Sulmasy. Theor Med Bioeth. 2008; 29(3):135). Whether or not a person intentionally seeks to form his/her conscience, it continues to be molded through the regular actions of daily life. The actions we perform – and those we omit – constantly shape our individual consciences. One’s conscience can indeed err due to emotional imbalance or faulty reasoning, but, even in these instances, it is essential to invest in the proper shaping of conscience in accordance with truth and goodness, rather than to reject the place of conscience altogether.

By attributing appropriate value to an individual’s conscience, we thereby recognize the centrality of conscience to identity and personal integrity. Consequently, we see that forcing an individual to impinge on his/her conscience through coercive means incidentally violates that person’s autonomy and dignity as a human being capable of moral decision-making.

In the practice of medicine, the free exercise of conscience is especially relevant. When patients and physicians meet to act in the pursuit of the patient’s health, they begin the process of conscience-mediated shared decision-making, rife with the potential for disagreement. Throughout this process, a physician should not violate a patient’s conscience rights by forcing medical treatment where it is unwanted, but neither should a patient violate a physician’s conscience rights by demanding a procedure or treatment that the physician cannot perform in good conscience. Moreover, to insert an external arbiter (eg, a professional society) to resolve the situation by means of contradiction of conscience would have the same violating effect on one or both parties.

One common debate as to the application of conscience in the setting of critical care focuses on the issue of physician-assisted suicide and euthanasia (PAS/E) (Rhee J, et al. Chest. 2017;152[3]. Accepted for Sept 2017 publication). Those who would deny physicians the right to conscientiously object to PAS/E depict this as merely an issue of the physician’s personal preference. Given the distinction between preference and conscience, however, we recognize that much more is at play. For students and practitioners who hold that health signifies the “well-working of the organism as a whole,” (Kass L. Public Interest. 1975; 40(summer):11-42) and feel that the killing of a patient is an action that goes directly against the health of the patient, the obligation to participate in PAS/E represents not only a violation of our decision-making dignity, but also subverts the critical component of clinical judgment inherent to our profession. The conscientiously practicing doctor who follows what they believe to be their professional obligations, acting in accordance with the health of the patient, may reasonably conclude that PAS/E directly contradicts their obligations to pursue the best health interests of the patient. As such, their refusal to participate can hardly be deemed a simple personal preference, as the refusal is both reasoned and reasonable. Indeed, experts have concluded that regardless of the legality of PAS/E, physicians must be allowed to conscientiously object to participate (Goligher et al. Crit Care Med. 2017; 45(2):149).

As medical students who have recently gone through the arduous medical school application process, we are particularly concerned with the claim that if one sees fit to exercise conscientious objection as a practitioner, they should leave medicine, or choose a field in medicine with few ethical dilemmas. To crassly exclude students from the pursuit of medicine on the basis of the shape of their conscience would be to unjustly discriminate by assigning different values to genuinely held beliefs. A direct consequence of this exclusion would be to decrease the diversity of thought, which is central to medical innovation and medical progress. History has taught us that the frontiers of medical advancement are most ardently pursued by those who think deeply and then dare to act creatively, seeking to bring to fruition what others deemed impossible. Without conscience rights, physicians are not free to think for themselves. We find it hard to believe that many physicians would feel comfortable jettisoning conscience in all instances where it may go against the wishes of their patients or the consensus opinion of the profession.

Furthermore, as medical students, we are acutely aware of the importance of conscientious objection due to the extant hierarchical nature of medical training. Evaluations are often performed by residents and physicians in places of authority, so students will readily subjugate everything from bodily needs to conscience in order to appease their attending physicians. Evidence indicates that medical students will even fail to object when they recognize medical errors performed by their superiors (Madigosky WS, et al. Acad Med. 2006; 81(1):94).

It is, therefore, crucial to the proper formation of medical students that our exercise of conscience be safeguarded during our training. A student who is free to exercise conscience is a student who is learning to think independently, as well as to shoulder the responsibility that comes as a consequence of free choices.

Ultimately, we must ask ourselves: how is the role of the physician altered if we choose to minimize the role of conscience in medicine? And do patients truly want physicians who forfeit their consciences even in matters of life and death? If we take the demands of those who dismiss conscience to their end – that only those willing to put their conscience aside should enter medicine – we would be left with practitioners whose group think training would stifle discussion between physicians and patients, and whose role would be reduced to simply acquiescing to any and all demands of the patient, even to their own detriment. Such a group of people, in our view, would fail to be physicians.

 

 

Author Affiliations: Geisel School of Medicine at Dartmouth, Hanover, NH (Dr. Dumitru); University of North Carolina School of Medicine, Chapel Hill, NC (Mr. Frush); Ohio University Heritage College of Osteopathic Medicine, Athens, OH (Mr. Radlicz); Columbia University College of Physicians and Surgeons, New York, NY (Mr. Allen); Thomas Jefferson School of Medicine, Philadelphia, PA (Mr. Brown); Faculty of Medicine & Dentistry, University of Alberta School, Edmonton, AB, Canada (Mr. Bannon); Icahn School of Medicine at Mount Sinai, New York, NY (Mr. Rhee).

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A Medical Student Perspective

 

When I invited Dr. Wes Ely – the coauthor of a recent article regarding physician-assisted suicide – to write a Critical Care Commentary on said topic, an interesting thing happened: he declined and suggested that I invite a group of students from medical schools across the country to write the piece instead. The idea was brilliant, and the resulting piece was so insightful that the CHEST® journal editorial leadership suggested submission to the journal, and the accepted article will appear in the September issue. Out of that effort, the idea for the present piece was born. The result is an opportunity to hear the students’ voices, not only to stimulate discussion on conscientious objection in medicine but also to remind the ICU community that our learners have their own opinions and that through dialogues such as this, we might all learn from one another.

Lee Morrow, MD, FCCP

“No provision in our Constitution ought to be dearer to man than that which protects the rights of conscience against the enterprises of the civil authority.” – Thomas Jefferson

(Washington HA. The Writings of Thomas Jefferson. New York: Biker, Thorne, & Co. 1854,; Vol 3:147.)

What is the proper role of conscience in medicine? A recent article in the New England Journal of Medicine (Stahl & Emmanuel. N Engl J Med. 2017; 376(14):1380) is the latest to address this question. It is often argued that physicians who cite conscience in refusing to perform requested procedures or treatments necessarily infringe upon patients’ rights. However, we feel that these concerns stem from a fundamental misunderstanding of what conscience is, why it ought to be respected as an indispensable part of medical judgment (Genuis & Lipp . Int J Family Med. 2013; Epub 2013 Dec 12), and how conscience is oriented toward the end goal of health, which we pursue in medicine.

By failing to define “conscience,” the crux of the argument against conscience rights is built on the basis of an implied diminution of conscience from an imperative moral judgment down to mere personal preference. If conscience represents only personal preference – if it is limited to a set of choices of the same moral equivalent as the selection of an ice cream flavor, with no need for technical expertise—then it would follow that a physician ought to simply comply with the patient’s decisions in any given medical situation. However, we know intuitively that this line of reasoning cannot hold, if followed to its conclusion. For example, if a patient presenting with symptoms of clear rhinorrhea and dry cough in December asks for an antibiotic, through this patient-sovereignty model, the physician surely ought to provide the prescription to honor the patient’s request. The patient would have every right to insist on the antibiotic, and the physician would be obliged to prescribe accordingly. We, as students, are trained, however, that it would be morally and professionally fitting, even obligatory, for the physician to refuse this request, precisely through exercise of his/her professional conscience.

If conscience, then, is not simply a subject of one’s personal preferences, how are we to properly understand it? Conscience is “a person’s moral sense of right and wrong, viewed as acting as a guide to one’s behavior” (Conscience. Oxford Dictionary. Oxford, Oxford University Press. 2017). It exhibits the commitment to engage in a “self-conscience activity, integrating reason, emotion, and will, in self-committed decisions about right and wrong, good and evil” (Sulmasy. Theor Med Bioeth. 2008; 29(3):135). Whether or not a person intentionally seeks to form his/her conscience, it continues to be molded through the regular actions of daily life. The actions we perform – and those we omit – constantly shape our individual consciences. One’s conscience can indeed err due to emotional imbalance or faulty reasoning, but, even in these instances, it is essential to invest in the proper shaping of conscience in accordance with truth and goodness, rather than to reject the place of conscience altogether.

By attributing appropriate value to an individual’s conscience, we thereby recognize the centrality of conscience to identity and personal integrity. Consequently, we see that forcing an individual to impinge on his/her conscience through coercive means incidentally violates that person’s autonomy and dignity as a human being capable of moral decision-making.

In the practice of medicine, the free exercise of conscience is especially relevant. When patients and physicians meet to act in the pursuit of the patient’s health, they begin the process of conscience-mediated shared decision-making, rife with the potential for disagreement. Throughout this process, a physician should not violate a patient’s conscience rights by forcing medical treatment where it is unwanted, but neither should a patient violate a physician’s conscience rights by demanding a procedure or treatment that the physician cannot perform in good conscience. Moreover, to insert an external arbiter (eg, a professional society) to resolve the situation by means of contradiction of conscience would have the same violating effect on one or both parties.

One common debate as to the application of conscience in the setting of critical care focuses on the issue of physician-assisted suicide and euthanasia (PAS/E) (Rhee J, et al. Chest. 2017;152[3]. Accepted for Sept 2017 publication). Those who would deny physicians the right to conscientiously object to PAS/E depict this as merely an issue of the physician’s personal preference. Given the distinction between preference and conscience, however, we recognize that much more is at play. For students and practitioners who hold that health signifies the “well-working of the organism as a whole,” (Kass L. Public Interest. 1975; 40(summer):11-42) and feel that the killing of a patient is an action that goes directly against the health of the patient, the obligation to participate in PAS/E represents not only a violation of our decision-making dignity, but also subverts the critical component of clinical judgment inherent to our profession. The conscientiously practicing doctor who follows what they believe to be their professional obligations, acting in accordance with the health of the patient, may reasonably conclude that PAS/E directly contradicts their obligations to pursue the best health interests of the patient. As such, their refusal to participate can hardly be deemed a simple personal preference, as the refusal is both reasoned and reasonable. Indeed, experts have concluded that regardless of the legality of PAS/E, physicians must be allowed to conscientiously object to participate (Goligher et al. Crit Care Med. 2017; 45(2):149).

As medical students who have recently gone through the arduous medical school application process, we are particularly concerned with the claim that if one sees fit to exercise conscientious objection as a practitioner, they should leave medicine, or choose a field in medicine with few ethical dilemmas. To crassly exclude students from the pursuit of medicine on the basis of the shape of their conscience would be to unjustly discriminate by assigning different values to genuinely held beliefs. A direct consequence of this exclusion would be to decrease the diversity of thought, which is central to medical innovation and medical progress. History has taught us that the frontiers of medical advancement are most ardently pursued by those who think deeply and then dare to act creatively, seeking to bring to fruition what others deemed impossible. Without conscience rights, physicians are not free to think for themselves. We find it hard to believe that many physicians would feel comfortable jettisoning conscience in all instances where it may go against the wishes of their patients or the consensus opinion of the profession.

Furthermore, as medical students, we are acutely aware of the importance of conscientious objection due to the extant hierarchical nature of medical training. Evaluations are often performed by residents and physicians in places of authority, so students will readily subjugate everything from bodily needs to conscience in order to appease their attending physicians. Evidence indicates that medical students will even fail to object when they recognize medical errors performed by their superiors (Madigosky WS, et al. Acad Med. 2006; 81(1):94).

It is, therefore, crucial to the proper formation of medical students that our exercise of conscience be safeguarded during our training. A student who is free to exercise conscience is a student who is learning to think independently, as well as to shoulder the responsibility that comes as a consequence of free choices.

Ultimately, we must ask ourselves: how is the role of the physician altered if we choose to minimize the role of conscience in medicine? And do patients truly want physicians who forfeit their consciences even in matters of life and death? If we take the demands of those who dismiss conscience to their end – that only those willing to put their conscience aside should enter medicine – we would be left with practitioners whose group think training would stifle discussion between physicians and patients, and whose role would be reduced to simply acquiescing to any and all demands of the patient, even to their own detriment. Such a group of people, in our view, would fail to be physicians.

 

 

Author Affiliations: Geisel School of Medicine at Dartmouth, Hanover, NH (Dr. Dumitru); University of North Carolina School of Medicine, Chapel Hill, NC (Mr. Frush); Ohio University Heritage College of Osteopathic Medicine, Athens, OH (Mr. Radlicz); Columbia University College of Physicians and Surgeons, New York, NY (Mr. Allen); Thomas Jefferson School of Medicine, Philadelphia, PA (Mr. Brown); Faculty of Medicine & Dentistry, University of Alberta School, Edmonton, AB, Canada (Mr. Bannon); Icahn School of Medicine at Mount Sinai, New York, NY (Mr. Rhee).

 

When I invited Dr. Wes Ely – the coauthor of a recent article regarding physician-assisted suicide – to write a Critical Care Commentary on said topic, an interesting thing happened: he declined and suggested that I invite a group of students from medical schools across the country to write the piece instead. The idea was brilliant, and the resulting piece was so insightful that the CHEST® journal editorial leadership suggested submission to the journal, and the accepted article will appear in the September issue. Out of that effort, the idea for the present piece was born. The result is an opportunity to hear the students’ voices, not only to stimulate discussion on conscientious objection in medicine but also to remind the ICU community that our learners have their own opinions and that through dialogues such as this, we might all learn from one another.

Lee Morrow, MD, FCCP

“No provision in our Constitution ought to be dearer to man than that which protects the rights of conscience against the enterprises of the civil authority.” – Thomas Jefferson

(Washington HA. The Writings of Thomas Jefferson. New York: Biker, Thorne, & Co. 1854,; Vol 3:147.)

What is the proper role of conscience in medicine? A recent article in the New England Journal of Medicine (Stahl & Emmanuel. N Engl J Med. 2017; 376(14):1380) is the latest to address this question. It is often argued that physicians who cite conscience in refusing to perform requested procedures or treatments necessarily infringe upon patients’ rights. However, we feel that these concerns stem from a fundamental misunderstanding of what conscience is, why it ought to be respected as an indispensable part of medical judgment (Genuis & Lipp . Int J Family Med. 2013; Epub 2013 Dec 12), and how conscience is oriented toward the end goal of health, which we pursue in medicine.

By failing to define “conscience,” the crux of the argument against conscience rights is built on the basis of an implied diminution of conscience from an imperative moral judgment down to mere personal preference. If conscience represents only personal preference – if it is limited to a set of choices of the same moral equivalent as the selection of an ice cream flavor, with no need for technical expertise—then it would follow that a physician ought to simply comply with the patient’s decisions in any given medical situation. However, we know intuitively that this line of reasoning cannot hold, if followed to its conclusion. For example, if a patient presenting with symptoms of clear rhinorrhea and dry cough in December asks for an antibiotic, through this patient-sovereignty model, the physician surely ought to provide the prescription to honor the patient’s request. The patient would have every right to insist on the antibiotic, and the physician would be obliged to prescribe accordingly. We, as students, are trained, however, that it would be morally and professionally fitting, even obligatory, for the physician to refuse this request, precisely through exercise of his/her professional conscience.

If conscience, then, is not simply a subject of one’s personal preferences, how are we to properly understand it? Conscience is “a person’s moral sense of right and wrong, viewed as acting as a guide to one’s behavior” (Conscience. Oxford Dictionary. Oxford, Oxford University Press. 2017). It exhibits the commitment to engage in a “self-conscience activity, integrating reason, emotion, and will, in self-committed decisions about right and wrong, good and evil” (Sulmasy. Theor Med Bioeth. 2008; 29(3):135). Whether or not a person intentionally seeks to form his/her conscience, it continues to be molded through the regular actions of daily life. The actions we perform – and those we omit – constantly shape our individual consciences. One’s conscience can indeed err due to emotional imbalance or faulty reasoning, but, even in these instances, it is essential to invest in the proper shaping of conscience in accordance with truth and goodness, rather than to reject the place of conscience altogether.

By attributing appropriate value to an individual’s conscience, we thereby recognize the centrality of conscience to identity and personal integrity. Consequently, we see that forcing an individual to impinge on his/her conscience through coercive means incidentally violates that person’s autonomy and dignity as a human being capable of moral decision-making.

In the practice of medicine, the free exercise of conscience is especially relevant. When patients and physicians meet to act in the pursuit of the patient’s health, they begin the process of conscience-mediated shared decision-making, rife with the potential for disagreement. Throughout this process, a physician should not violate a patient’s conscience rights by forcing medical treatment where it is unwanted, but neither should a patient violate a physician’s conscience rights by demanding a procedure or treatment that the physician cannot perform in good conscience. Moreover, to insert an external arbiter (eg, a professional society) to resolve the situation by means of contradiction of conscience would have the same violating effect on one or both parties.

One common debate as to the application of conscience in the setting of critical care focuses on the issue of physician-assisted suicide and euthanasia (PAS/E) (Rhee J, et al. Chest. 2017;152[3]. Accepted for Sept 2017 publication). Those who would deny physicians the right to conscientiously object to PAS/E depict this as merely an issue of the physician’s personal preference. Given the distinction between preference and conscience, however, we recognize that much more is at play. For students and practitioners who hold that health signifies the “well-working of the organism as a whole,” (Kass L. Public Interest. 1975; 40(summer):11-42) and feel that the killing of a patient is an action that goes directly against the health of the patient, the obligation to participate in PAS/E represents not only a violation of our decision-making dignity, but also subverts the critical component of clinical judgment inherent to our profession. The conscientiously practicing doctor who follows what they believe to be their professional obligations, acting in accordance with the health of the patient, may reasonably conclude that PAS/E directly contradicts their obligations to pursue the best health interests of the patient. As such, their refusal to participate can hardly be deemed a simple personal preference, as the refusal is both reasoned and reasonable. Indeed, experts have concluded that regardless of the legality of PAS/E, physicians must be allowed to conscientiously object to participate (Goligher et al. Crit Care Med. 2017; 45(2):149).

As medical students who have recently gone through the arduous medical school application process, we are particularly concerned with the claim that if one sees fit to exercise conscientious objection as a practitioner, they should leave medicine, or choose a field in medicine with few ethical dilemmas. To crassly exclude students from the pursuit of medicine on the basis of the shape of their conscience would be to unjustly discriminate by assigning different values to genuinely held beliefs. A direct consequence of this exclusion would be to decrease the diversity of thought, which is central to medical innovation and medical progress. History has taught us that the frontiers of medical advancement are most ardently pursued by those who think deeply and then dare to act creatively, seeking to bring to fruition what others deemed impossible. Without conscience rights, physicians are not free to think for themselves. We find it hard to believe that many physicians would feel comfortable jettisoning conscience in all instances where it may go against the wishes of their patients or the consensus opinion of the profession.

Furthermore, as medical students, we are acutely aware of the importance of conscientious objection due to the extant hierarchical nature of medical training. Evaluations are often performed by residents and physicians in places of authority, so students will readily subjugate everything from bodily needs to conscience in order to appease their attending physicians. Evidence indicates that medical students will even fail to object when they recognize medical errors performed by their superiors (Madigosky WS, et al. Acad Med. 2006; 81(1):94).

It is, therefore, crucial to the proper formation of medical students that our exercise of conscience be safeguarded during our training. A student who is free to exercise conscience is a student who is learning to think independently, as well as to shoulder the responsibility that comes as a consequence of free choices.

Ultimately, we must ask ourselves: how is the role of the physician altered if we choose to minimize the role of conscience in medicine? And do patients truly want physicians who forfeit their consciences even in matters of life and death? If we take the demands of those who dismiss conscience to their end – that only those willing to put their conscience aside should enter medicine – we would be left with practitioners whose group think training would stifle discussion between physicians and patients, and whose role would be reduced to simply acquiescing to any and all demands of the patient, even to their own detriment. Such a group of people, in our view, would fail to be physicians.

 

 

Author Affiliations: Geisel School of Medicine at Dartmouth, Hanover, NH (Dr. Dumitru); University of North Carolina School of Medicine, Chapel Hill, NC (Mr. Frush); Ohio University Heritage College of Osteopathic Medicine, Athens, OH (Mr. Radlicz); Columbia University College of Physicians and Surgeons, New York, NY (Mr. Allen); Thomas Jefferson School of Medicine, Philadelphia, PA (Mr. Brown); Faculty of Medicine & Dentistry, University of Alberta School, Edmonton, AB, Canada (Mr. Bannon); Icahn School of Medicine at Mount Sinai, New York, NY (Mr. Rhee).

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FDA approves faster, pangenotypic cure for hep C virus

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Mon, 08/07/2017 - 12:00

 



The first pangenotypic treatment for the hepatitis C virus, which also shaves 4 weeks off current regimens, has just been approved by the Food and Drug Administration.

Manufactured by AbbVie, glecaprevir/pibrentasvir (Mavyret) combines a nonstructural protein 3/4A protease inhibitor with a next-generation NS5A protein inhibitor for a once-daily, ribavirin-free treatment for adults with any of the major genotypes of chronic hepatitis C virus (HCV) infection.

“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, Silver Spring, Md., said in a statement.



The 8-week regimen is indicated in patients without cirrhosis or with compensated cirrhosis, who are new to treatment, and those with limited treatment options, such as patients with chronic kidney disease, including those on dialysis. The intervention also is indicated in adults with HCV genotype 1 who have been treated with either of the drugs in the combination, but not both. Glecaprevir/pibrentasvir is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and in those taking the drugs atazanavir and rifampin.

The safety and efficacy of the treatment were evaluated in approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. In the clinical trials, between 92% and 100% of patients treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks had no detectable serum levels of the virus 12 weeks after finishing treatment. The most commonly reported adverse reactions were headache, fatigue, and nausea.

The FDA directs health care professionals to test all patients for current or prior hepatitis B virus (HBV) infection prior to starting this direct-acting antiviral drug combination since HBV reactivation has been reported in adult patients coinfected with both viruses who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy.

The AGA HCV Clinical Service Line provides tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c

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The first pangenotypic treatment for the hepatitis C virus, which also shaves 4 weeks off current regimens, has just been approved by the Food and Drug Administration.

Manufactured by AbbVie, glecaprevir/pibrentasvir (Mavyret) combines a nonstructural protein 3/4A protease inhibitor with a next-generation NS5A protein inhibitor for a once-daily, ribavirin-free treatment for adults with any of the major genotypes of chronic hepatitis C virus (HCV) infection.

“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, Silver Spring, Md., said in a statement.



The 8-week regimen is indicated in patients without cirrhosis or with compensated cirrhosis, who are new to treatment, and those with limited treatment options, such as patients with chronic kidney disease, including those on dialysis. The intervention also is indicated in adults with HCV genotype 1 who have been treated with either of the drugs in the combination, but not both. Glecaprevir/pibrentasvir is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and in those taking the drugs atazanavir and rifampin.

The safety and efficacy of the treatment were evaluated in approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. In the clinical trials, between 92% and 100% of patients treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks had no detectable serum levels of the virus 12 weeks after finishing treatment. The most commonly reported adverse reactions were headache, fatigue, and nausea.

The FDA directs health care professionals to test all patients for current or prior hepatitis B virus (HBV) infection prior to starting this direct-acting antiviral drug combination since HBV reactivation has been reported in adult patients coinfected with both viruses who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy.

The AGA HCV Clinical Service Line provides tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c

 



The first pangenotypic treatment for the hepatitis C virus, which also shaves 4 weeks off current regimens, has just been approved by the Food and Drug Administration.

Manufactured by AbbVie, glecaprevir/pibrentasvir (Mavyret) combines a nonstructural protein 3/4A protease inhibitor with a next-generation NS5A protein inhibitor for a once-daily, ribavirin-free treatment for adults with any of the major genotypes of chronic hepatitis C virus (HCV) infection.

“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research, Silver Spring, Md., said in a statement.



The 8-week regimen is indicated in patients without cirrhosis or with compensated cirrhosis, who are new to treatment, and those with limited treatment options, such as patients with chronic kidney disease, including those on dialysis. The intervention also is indicated in adults with HCV genotype 1 who have been treated with either of the drugs in the combination, but not both. Glecaprevir/pibrentasvir is not recommended in patients with moderate cirrhosis and is contraindicated in patients with severe cirrhosis and in those taking the drugs atazanavir and rifampin.

The safety and efficacy of the treatment were evaluated in approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. In the clinical trials, between 92% and 100% of patients treated with glecaprevir/pibrentasvir for 8, 12, or 16 weeks had no detectable serum levels of the virus 12 weeks after finishing treatment. The most commonly reported adverse reactions were headache, fatigue, and nausea.

The FDA directs health care professionals to test all patients for current or prior hepatitis B virus (HBV) infection prior to starting this direct-acting antiviral drug combination since HBV reactivation has been reported in adult patients coinfected with both viruses who were undergoing or had completed treatment with HCV direct-acting antivirals and who were not receiving HBV antiviral therapy.

The AGA HCV Clinical Service Line provides tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c

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Here There Be Dragons …

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Wed, 04/03/2019 - 10:26

For the public, navigating the complex world of vascular care must seem like being adrift on the high seas, with brigands and pirates galore. Vascular surgeons, cardiac surgeons, interventional radiologists, and interventional cardiologists all raise their friendly flags to lure patients. How about vascular medicine, interventional nephrology, and other specialties that sound like a Medical Mad Libs game gone bad? Where to go for care? What is a Heart and Vascular Center? And what about those freestanding labs? You can practically hear the sweet sound of unindicated atherectomies from the streets outside. 

Renal stents, EVAR, SFA interventions, EVLT. The question is not who can do them, but who should? When I was a child, I assumed adults were smart. Adults must always have a plan. Now, faced with daily incontrovertible evidence to the contrary, I am ready to cede these points. There is no plan, but there should be.

Dr. Sheahan

In the mid-2000s, interventional cardiologists, faced with declining coronary interventions, expanded their interest in other vascular territories. Somehow, despite every metric showing a reduction in their case volume, interventional cardiologists grew their workforce in historic fashion. Between 2008 and 2013, the U.S. workforce of interventional cardiologists nearly doubled, the largest expansion of any medical or surgical specialty. Number two on the list? Interventional Radiology.

I believe the crux of this matter lies in the training of physicians. In the United States, the Accreditation Council for Graduate Medical Education (ACGME) sets standards and accredits residency and fellowship programs. Let us review their educational requirements and expectations for these programs with regard to peripheral vascular disease and treatment. First, throw out Vascular Medicine and Interventional Nephrology. The ACGME recognizes 150 specialties and subspecialties, but not these 2. Similarly, the American Board of Medical Specialties offers no certification in these self-designated fields.

Interventional cardiology, according to the ACGME, is “the practice of techniques that improve coronary circulation, alleviate valvular stenosis and regurgitation, and treat other structural heart disease.” Sounds good to me. Looking through the 33-page document that details the requirements for training in interventional cardiology, how often does the word carotid appear? Never. Venous? Zero. Aortic aneurysm? Nada. Any reference to peripheral vascular disease at all? Nope. Indeed the only requirement for knowledge of the peripheral vascular anatomy is in reference to percutaneous approaches to the heart. There is, however, a prerequisite for “application of evidence to patient care and advocacy for quality of care.”  It seems the ACGME has my back here. 

For other specialties, the training requirements have a tenuous, at best, relationship with vascular interventions. Thoracic Surgery trainees are required to have knowledge of abnormalities of the great vessels and thoracic aorta, but nothing beyond. Interventional radiology trainees must learn to perform “arterial and venous interventions;” but no specific vascular regions are given. Dermatologists need knowledge of vein therapies but neither performance of these procedures nor even direct observation are required. 
What then of the trainee case logs? Evidence of their clinical experience? Trainees in interventional cardiology and interventional radiology are not required to use the ACGME case logs. Interventional cardiology fellows only use self-reported case logs and the sole requirement is 250 coronary interventions. In fact, of all the germane specialties, only vascular surgery requires detailed reporting with minimum requirements in multiple vascular trees. Vascular surgery is also the only relevant specialty to report the national averages of the graduates’ case volumes on the public ACGME website.

Education is a process; we acquire competence from the competent. The treatment of peripheral vascular disease is a vocation, not a hobby. “Interest” or even “experience” does not translate to aptitude and proficiency. Whatever one’s issues with the ACGME, they have laid out the most rigorous standards for medical training that exist. Vascular surgery is the only specialty requiring and documenting comprehensive vascular training in all six competencies mandated by the ACGME. Who will tell my trainees, after years of residency, that someone doing a series of unregulated extracurricular activities has had an “equivalent experience”? 

Technical teaching without cognitive instruction often results in inappropriate application of treatments. Costs rise and quality falls. Repeated exposure to a technique without consequence or accountability is not training. My 5 year old likes to sit on my lap and steer the car around the parking lot but I do not recommend you let him take you to the airport. What-to-do takes longer to learn than how-to-do-it. In the early years after your training finished, when you called your mentor about a case, what did you ask? In most instances, the question was not how to technically perform a task, but rather what task to do. 

The public’s trust in our training and motivation is implicit and necessary. But even doctors have difficulty determining the legitimacy of other specialties’ training in vascular pathology. To say nothing of the public or credentialing committees. Institutions like the ACGME should condemn physicians who chose to practice medicine that bears little resemblance to their intended training. 

Peter Lawrence, MD, commenting on this issue in a letter to the New York Times (Feb. 12, 2015), wrote “Vascular Specialists need an in-depth understanding of vascular disease, as well as technical skill, but they also need the ethics to treat patients like a brother or sister, not the source of a payment for a new car.” Allowing so many practitioners to use unregulated pathways to gain credentialing in vascular interventions is folly. Vascular surgeons are the only specialists who have undergone comprehensive accredited training in the care of the vascular patient. We have more than seen it. We have more than done it. We have understood it. 

Marriage, and 13 years working for a state institution, have taught me that it is far easier to change one’s own behavior than another’s. As a specialty, we share in the blame for this quagmire. We have been slow to grow our training programs thereby creating a shortage of vascular surgeons. Where we do not exist, others are happy to take up the slack. We cannot make the argument that these are our cases if we cannot cover them. Secondly, we have little public identity. Many medical students do not even understand the role of the vascular surgeon. 
We have seemingly failed to brand ourselves to anyone but ourselves. The public must know who we are, where we are, and what we do. This is essential.

Dr. Sheahan is a professor of surgery and Program Director, Vascular Surgery Residency and Fellowship Programs, Louisiana State University Health Sciences Center, School of Medicine, New Orleans. He is also the Deputy Medical Editor of Vascular Specialist.

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For the public, navigating the complex world of vascular care must seem like being adrift on the high seas, with brigands and pirates galore. Vascular surgeons, cardiac surgeons, interventional radiologists, and interventional cardiologists all raise their friendly flags to lure patients. How about vascular medicine, interventional nephrology, and other specialties that sound like a Medical Mad Libs game gone bad? Where to go for care? What is a Heart and Vascular Center? And what about those freestanding labs? You can practically hear the sweet sound of unindicated atherectomies from the streets outside. 

Renal stents, EVAR, SFA interventions, EVLT. The question is not who can do them, but who should? When I was a child, I assumed adults were smart. Adults must always have a plan. Now, faced with daily incontrovertible evidence to the contrary, I am ready to cede these points. There is no plan, but there should be.

Dr. Sheahan

In the mid-2000s, interventional cardiologists, faced with declining coronary interventions, expanded their interest in other vascular territories. Somehow, despite every metric showing a reduction in their case volume, interventional cardiologists grew their workforce in historic fashion. Between 2008 and 2013, the U.S. workforce of interventional cardiologists nearly doubled, the largest expansion of any medical or surgical specialty. Number two on the list? Interventional Radiology.

I believe the crux of this matter lies in the training of physicians. In the United States, the Accreditation Council for Graduate Medical Education (ACGME) sets standards and accredits residency and fellowship programs. Let us review their educational requirements and expectations for these programs with regard to peripheral vascular disease and treatment. First, throw out Vascular Medicine and Interventional Nephrology. The ACGME recognizes 150 specialties and subspecialties, but not these 2. Similarly, the American Board of Medical Specialties offers no certification in these self-designated fields.

Interventional cardiology, according to the ACGME, is “the practice of techniques that improve coronary circulation, alleviate valvular stenosis and regurgitation, and treat other structural heart disease.” Sounds good to me. Looking through the 33-page document that details the requirements for training in interventional cardiology, how often does the word carotid appear? Never. Venous? Zero. Aortic aneurysm? Nada. Any reference to peripheral vascular disease at all? Nope. Indeed the only requirement for knowledge of the peripheral vascular anatomy is in reference to percutaneous approaches to the heart. There is, however, a prerequisite for “application of evidence to patient care and advocacy for quality of care.”  It seems the ACGME has my back here. 

For other specialties, the training requirements have a tenuous, at best, relationship with vascular interventions. Thoracic Surgery trainees are required to have knowledge of abnormalities of the great vessels and thoracic aorta, but nothing beyond. Interventional radiology trainees must learn to perform “arterial and venous interventions;” but no specific vascular regions are given. Dermatologists need knowledge of vein therapies but neither performance of these procedures nor even direct observation are required. 
What then of the trainee case logs? Evidence of their clinical experience? Trainees in interventional cardiology and interventional radiology are not required to use the ACGME case logs. Interventional cardiology fellows only use self-reported case logs and the sole requirement is 250 coronary interventions. In fact, of all the germane specialties, only vascular surgery requires detailed reporting with minimum requirements in multiple vascular trees. Vascular surgery is also the only relevant specialty to report the national averages of the graduates’ case volumes on the public ACGME website.

Education is a process; we acquire competence from the competent. The treatment of peripheral vascular disease is a vocation, not a hobby. “Interest” or even “experience” does not translate to aptitude and proficiency. Whatever one’s issues with the ACGME, they have laid out the most rigorous standards for medical training that exist. Vascular surgery is the only specialty requiring and documenting comprehensive vascular training in all six competencies mandated by the ACGME. Who will tell my trainees, after years of residency, that someone doing a series of unregulated extracurricular activities has had an “equivalent experience”? 

Technical teaching without cognitive instruction often results in inappropriate application of treatments. Costs rise and quality falls. Repeated exposure to a technique without consequence or accountability is not training. My 5 year old likes to sit on my lap and steer the car around the parking lot but I do not recommend you let him take you to the airport. What-to-do takes longer to learn than how-to-do-it. In the early years after your training finished, when you called your mentor about a case, what did you ask? In most instances, the question was not how to technically perform a task, but rather what task to do. 

The public’s trust in our training and motivation is implicit and necessary. But even doctors have difficulty determining the legitimacy of other specialties’ training in vascular pathology. To say nothing of the public or credentialing committees. Institutions like the ACGME should condemn physicians who chose to practice medicine that bears little resemblance to their intended training. 

Peter Lawrence, MD, commenting on this issue in a letter to the New York Times (Feb. 12, 2015), wrote “Vascular Specialists need an in-depth understanding of vascular disease, as well as technical skill, but they also need the ethics to treat patients like a brother or sister, not the source of a payment for a new car.” Allowing so many practitioners to use unregulated pathways to gain credentialing in vascular interventions is folly. Vascular surgeons are the only specialists who have undergone comprehensive accredited training in the care of the vascular patient. We have more than seen it. We have more than done it. We have understood it. 

Marriage, and 13 years working for a state institution, have taught me that it is far easier to change one’s own behavior than another’s. As a specialty, we share in the blame for this quagmire. We have been slow to grow our training programs thereby creating a shortage of vascular surgeons. Where we do not exist, others are happy to take up the slack. We cannot make the argument that these are our cases if we cannot cover them. Secondly, we have little public identity. Many medical students do not even understand the role of the vascular surgeon. 
We have seemingly failed to brand ourselves to anyone but ourselves. The public must know who we are, where we are, and what we do. This is essential.

Dr. Sheahan is a professor of surgery and Program Director, Vascular Surgery Residency and Fellowship Programs, Louisiana State University Health Sciences Center, School of Medicine, New Orleans. He is also the Deputy Medical Editor of Vascular Specialist.

For the public, navigating the complex world of vascular care must seem like being adrift on the high seas, with brigands and pirates galore. Vascular surgeons, cardiac surgeons, interventional radiologists, and interventional cardiologists all raise their friendly flags to lure patients. How about vascular medicine, interventional nephrology, and other specialties that sound like a Medical Mad Libs game gone bad? Where to go for care? What is a Heart and Vascular Center? And what about those freestanding labs? You can practically hear the sweet sound of unindicated atherectomies from the streets outside. 

Renal stents, EVAR, SFA interventions, EVLT. The question is not who can do them, but who should? When I was a child, I assumed adults were smart. Adults must always have a plan. Now, faced with daily incontrovertible evidence to the contrary, I am ready to cede these points. There is no plan, but there should be.

Dr. Sheahan

In the mid-2000s, interventional cardiologists, faced with declining coronary interventions, expanded their interest in other vascular territories. Somehow, despite every metric showing a reduction in their case volume, interventional cardiologists grew their workforce in historic fashion. Between 2008 and 2013, the U.S. workforce of interventional cardiologists nearly doubled, the largest expansion of any medical or surgical specialty. Number two on the list? Interventional Radiology.

I believe the crux of this matter lies in the training of physicians. In the United States, the Accreditation Council for Graduate Medical Education (ACGME) sets standards and accredits residency and fellowship programs. Let us review their educational requirements and expectations for these programs with regard to peripheral vascular disease and treatment. First, throw out Vascular Medicine and Interventional Nephrology. The ACGME recognizes 150 specialties and subspecialties, but not these 2. Similarly, the American Board of Medical Specialties offers no certification in these self-designated fields.

Interventional cardiology, according to the ACGME, is “the practice of techniques that improve coronary circulation, alleviate valvular stenosis and regurgitation, and treat other structural heart disease.” Sounds good to me. Looking through the 33-page document that details the requirements for training in interventional cardiology, how often does the word carotid appear? Never. Venous? Zero. Aortic aneurysm? Nada. Any reference to peripheral vascular disease at all? Nope. Indeed the only requirement for knowledge of the peripheral vascular anatomy is in reference to percutaneous approaches to the heart. There is, however, a prerequisite for “application of evidence to patient care and advocacy for quality of care.”  It seems the ACGME has my back here. 

For other specialties, the training requirements have a tenuous, at best, relationship with vascular interventions. Thoracic Surgery trainees are required to have knowledge of abnormalities of the great vessels and thoracic aorta, but nothing beyond. Interventional radiology trainees must learn to perform “arterial and venous interventions;” but no specific vascular regions are given. Dermatologists need knowledge of vein therapies but neither performance of these procedures nor even direct observation are required. 
What then of the trainee case logs? Evidence of their clinical experience? Trainees in interventional cardiology and interventional radiology are not required to use the ACGME case logs. Interventional cardiology fellows only use self-reported case logs and the sole requirement is 250 coronary interventions. In fact, of all the germane specialties, only vascular surgery requires detailed reporting with minimum requirements in multiple vascular trees. Vascular surgery is also the only relevant specialty to report the national averages of the graduates’ case volumes on the public ACGME website.

Education is a process; we acquire competence from the competent. The treatment of peripheral vascular disease is a vocation, not a hobby. “Interest” or even “experience” does not translate to aptitude and proficiency. Whatever one’s issues with the ACGME, they have laid out the most rigorous standards for medical training that exist. Vascular surgery is the only specialty requiring and documenting comprehensive vascular training in all six competencies mandated by the ACGME. Who will tell my trainees, after years of residency, that someone doing a series of unregulated extracurricular activities has had an “equivalent experience”? 

Technical teaching without cognitive instruction often results in inappropriate application of treatments. Costs rise and quality falls. Repeated exposure to a technique without consequence or accountability is not training. My 5 year old likes to sit on my lap and steer the car around the parking lot but I do not recommend you let him take you to the airport. What-to-do takes longer to learn than how-to-do-it. In the early years after your training finished, when you called your mentor about a case, what did you ask? In most instances, the question was not how to technically perform a task, but rather what task to do. 

The public’s trust in our training and motivation is implicit and necessary. But even doctors have difficulty determining the legitimacy of other specialties’ training in vascular pathology. To say nothing of the public or credentialing committees. Institutions like the ACGME should condemn physicians who chose to practice medicine that bears little resemblance to their intended training. 

Peter Lawrence, MD, commenting on this issue in a letter to the New York Times (Feb. 12, 2015), wrote “Vascular Specialists need an in-depth understanding of vascular disease, as well as technical skill, but they also need the ethics to treat patients like a brother or sister, not the source of a payment for a new car.” Allowing so many practitioners to use unregulated pathways to gain credentialing in vascular interventions is folly. Vascular surgeons are the only specialists who have undergone comprehensive accredited training in the care of the vascular patient. We have more than seen it. We have more than done it. We have understood it. 

Marriage, and 13 years working for a state institution, have taught me that it is far easier to change one’s own behavior than another’s. As a specialty, we share in the blame for this quagmire. We have been slow to grow our training programs thereby creating a shortage of vascular surgeons. Where we do not exist, others are happy to take up the slack. We cannot make the argument that these are our cases if we cannot cover them. Secondly, we have little public identity. Many medical students do not even understand the role of the vascular surgeon. 
We have seemingly failed to brand ourselves to anyone but ourselves. The public must know who we are, where we are, and what we do. This is essential.

Dr. Sheahan is a professor of surgery and Program Director, Vascular Surgery Residency and Fellowship Programs, Louisiana State University Health Sciences Center, School of Medicine, New Orleans. He is also the Deputy Medical Editor of Vascular Specialist.

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Vaccination: An Important Step in Protecting Health

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Patients with chronic lung conditions, like COPD and asthma, need to take extra steps to manage their condition and ensure the healthiest possible future. One important step that may not always be top of mind is vaccination, which can protect against common preventable diseases that may be very serious for those with respiratory conditions. CDC recommends adults with COPD, asthma, and other lung diseases get an annual flu vaccine, as well as stay up to date with pneumococcal and other recommended vaccines. Additional vaccines may be indicated based on age, job, travel locations, and lifestyle.

COPD and asthma cause airways to swell and become blocked with mucus, making it hard to breathe. Certain vaccine-preventable diseases can make this even worse. Adults with COPD and asthma are at increased risk of complications from influenza, including pneumonia and hospitalization. They are also at higher risk for invasive pneumococcal disease and more likely to develop infections including bacteremia and meningitis. Each year, thousands of adults needlessly suffer, are hospitalized, and even die of diseases that could be prevented by vaccines. Despite increased risks, less than half of adults under 65 years with COPD and asthma have received influenza and pneumococcal vaccination (National Health Information Survey 2015).

Find the latest recommended adult immunization schedule at www.cdc.gov/vaccines/hcp/adults.

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Patients with chronic lung conditions, like COPD and asthma, need to take extra steps to manage their condition and ensure the healthiest possible future. One important step that may not always be top of mind is vaccination, which can protect against common preventable diseases that may be very serious for those with respiratory conditions. CDC recommends adults with COPD, asthma, and other lung diseases get an annual flu vaccine, as well as stay up to date with pneumococcal and other recommended vaccines. Additional vaccines may be indicated based on age, job, travel locations, and lifestyle.

COPD and asthma cause airways to swell and become blocked with mucus, making it hard to breathe. Certain vaccine-preventable diseases can make this even worse. Adults with COPD and asthma are at increased risk of complications from influenza, including pneumonia and hospitalization. They are also at higher risk for invasive pneumococcal disease and more likely to develop infections including bacteremia and meningitis. Each year, thousands of adults needlessly suffer, are hospitalized, and even die of diseases that could be prevented by vaccines. Despite increased risks, less than half of adults under 65 years with COPD and asthma have received influenza and pneumococcal vaccination (National Health Information Survey 2015).

Find the latest recommended adult immunization schedule at www.cdc.gov/vaccines/hcp/adults.

 

Patients with chronic lung conditions, like COPD and asthma, need to take extra steps to manage their condition and ensure the healthiest possible future. One important step that may not always be top of mind is vaccination, which can protect against common preventable diseases that may be very serious for those with respiratory conditions. CDC recommends adults with COPD, asthma, and other lung diseases get an annual flu vaccine, as well as stay up to date with pneumococcal and other recommended vaccines. Additional vaccines may be indicated based on age, job, travel locations, and lifestyle.

COPD and asthma cause airways to swell and become blocked with mucus, making it hard to breathe. Certain vaccine-preventable diseases can make this even worse. Adults with COPD and asthma are at increased risk of complications from influenza, including pneumonia and hospitalization. They are also at higher risk for invasive pneumococcal disease and more likely to develop infections including bacteremia and meningitis. Each year, thousands of adults needlessly suffer, are hospitalized, and even die of diseases that could be prevented by vaccines. Despite increased risks, less than half of adults under 65 years with COPD and asthma have received influenza and pneumococcal vaccination (National Health Information Survey 2015).

Find the latest recommended adult immunization schedule at www.cdc.gov/vaccines/hcp/adults.

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NETWORKS Health-care weaponization, PTSD, depression in caregivers Disaster Response Practice Operations Transplant Women’s Health

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The tragic weaponization of health care

The Syrian conflict has highlighted the dangers to health-care workers (HCWs) in humanitarian crises. The Lancet-American University of Beirut Commission on Syria reports on the weaponization of health care in Syria – a strategy of depriving people of their health-care needs. Targeting of HCWs was recognized early in the Syrian war with targeting of health-care facilities being frequently reported throughout the conflict. HCWs facing extreme supply shortages have been reported to resort to desperate measures: using urine bags with added anticoagulants for blood collection and crafting homemade external fixators for fractures. Sadly, the Syrian conflict is not unique. The International Committee of the Red Cross (ICRC) documented 2,398 episodes of violence directed at health facilities in 11 countries affected by armed conflict between 2012 and 2014 alone. In Syria and elsewhere, the exodus of trained medical personnel, due to lack of medical training in trauma, emergency medicine, and intensive care, puts populations at further risk in these regions. The Inte

rnational Red Cross and Red Crescent Movement has started the Health Care in Danger (http://http://healthcareindanger.org) initiative to highlight this weaponization of health, supporting efforts by HCWs to advocate for their rights and their patients’ rights at a global level. This highlights the needs for CHEST members responding to humanitarian crises to ensure they have appropriate training to work in these environments and deploy with an organization that can provide adequate safeguards.

Dr. Maves is a military service member. The opinions expressed herein are his own and do not necessarily reflect the official opinions of the Department of the Navy, Department of Defense, or the US Government.

Rashmi Mishra, MD

Fellow-in-Training Member

Ryan Maves, MD, FCCP


Steering Committee Member

The House AHCA /Senate BCRA compared with ACA (Affordable Care Act)

Health-care costs are a fundamental driver of insurance costs, which leads to challenges to coverage affordability for millions of families. There is ongoing debate whether the current law (Affordable Care Act [ACA/Obamacare]) and the republican alternatives (American Healthcare Act [AHCA] and Better Care Reconciliation Act [BCRA]) do enough to address the cost challenges. Here is a brief summary of the key similarities and differences.

Similarities: (1) Children will be covered up to age 26. (2) Coverage of pre-existing conditions continues (high risk pools will be subsidized by a state government but premiums are up to twice as much as individual coverage). (3) Tax credit (based on age and family size rather than income level). (4) Insurance can charge older customers more than younger (up to 3X under ACA, 5X under AHCA/BCRA). (5) No annual or lifetime payout limit (but states may apply waivers allowing insurers to apply limits).

Differences: (1) Insurance will no longer be mandatory (no individual or employer mandates, but there is a 30% increase in premiums for 1 year for not maintaining individual continuous coverage). (2) Medicaid expansion (expanded under ACA to 133% of po

verty level income) will stop in 2020. (3) Restriction on “Abortion Funding” (any facility that offers abortion will not receive federal funding) for 1 year. (4) Taxes on health care will be removed (including taxes on prescription drugs, OTC, premiums, and medical devices). (5) Allowing policies for major illness or injury (with elimination of the requirement to cover ten essential health benefits, allowing states to modify).

Health-care reform undoubtedly is complicated, and there are a lot of questions in the air about the future of health care under the Trump Administration. Few certainties: change is coming, MACRA is here to stay.

Adel Bassily-Marcus, MD, FCCP

NetWork Chair

Posttraumatic Stress Disorder Post-Lung Transplant

The majority of transplant physicians are mainly concerned with issues posttransplant that are focused on the graft function. But recently, neurocognition and posttransplant posttraumatic stress disorder have been found to have significant impact on quality of life and mortality after transplantation. Posttraumatic stress disorder (PTSD) is described as re-experiencing a traumatic event in addition to having avoidant and hyperarousal symptoms, which last for a period of at least 1 month. Studies of PTSD in solid organ transplant recipients have revealed a significantly higher prevalence of PTSD symptoms (10% to 17%) compared with the general population (prevalence of 3.5% to 6%). In one study of heart transplant recipients, patients who met the criteria for PTSD in the first year posttransplant had a higher risk for 3-year mortality (OR=13.74) [Dew et al. J Heart Lung Transplant. 1999;18[6]:549-562].

Lung transplant recipients are at a high risk for developing PTSD due to exposure to several traumatic events, such as a life-threatening exacerbation of the underlying lung disease, undergoing transplant surgery, intensive care unit stay, delirium and episodes of infection, and acute and chronic rejection. However, data regarding the prevalence and risk factors for PTSD post-lung transplant are limited.

The prevalence of PTSD post lung transplantation has been reported to be 12.6% to 15.8%. In lung transplant recipients with clinically significant PTSD symptomatology; the presence of symptoms of re-experiencing (29.5%) and arousal (33.8%) were more common than avoidant symptoms (18.4%) [Gries et al. J Heart Lung Transplant. 2013; 32[5]: 525-532]. In another study by Dew et al, in 178 lung transplant recipients, all PTSD occurred in the early months posttransplant with a median duration of symptoms of 12 months (IQR 7.2 to 18.5 months) [Dew et al. Gen. Hosp Psychiatry. 2012;34:127-138]. A higher burden of PTSD is noted in patients who are younger, have a lo

wer income, have a previous history of a traumatic event, and have bronchiolitis obliterans (Gries et al. J Heart Lung Transplant. 2013;32[5]:525-532).

The challenges that remain include determining the true prevalence of PTSD in the lung transplant recipient in the LAS era using standard diagnostic criteria, documenting the adverse effects of PTSD on medical compliance, morbidity, and mortality; and developing interventions to mitigate the adverse effects of PTSD through well-designed multicenter prospective studies.

 

 

Vivek Ahya, MD

Steering Committee Member

Caregiver Burden in the ICU and Beyond

Family members of patients in the ICU who transition to the role of caregivers following discharge are at high risk for psychosocial distress. Post-intensive care syndrome-family (PICS-F) describes the symptoms of depression, posttraumatic stress, and anxiety commonly found in this population (Davidson et al. Crit Care Med. 2012;4(2):618-624). Women are more commonly called upon to adopt the role of caregiver for family members with chronic medical conditions or mental illnesses. Worldwide estimates indicate that 57% to 81% of all caregivers are women (Sharma et al. World J Psych. 2016;6[2]:7-17).

Family burden begins during the acute phase of critical illness. As surrogate decision-makers, they frequently face decisional conflict and decisional regret, especially in scenarios that limit life-sustaining therapies (Long et al. Curr Opin Crit Care. 2016;22:613-620). The prevalence of PICS-F is high as family members attempt to balance their role in the ICU with personal obligations (Choi et al. J Korean Acad Nurs. 2016;[46]2:159-167). Those who perceive that they are not receiving complete information from the medical team, and who do not find their physician comforting, have been shown to suffer a greater symptom burden (Davidson et al).

With the growing older adult population, and increased ICU survival, family members are often called upon to serve as caretakers to the chronically critically ill (Choi et al.). These caregivers have more depressive symptoms, worse health outcomes, and significant professional and personal lifestyle disruptions (Cameron, et al. N Engl J Med. 2016;[374]19:1831-1841). In many caregivers, depressive symptoms persist at 1 year after ICU admission, with rates comparable to caretakers of patients with dementia (Haines et al. Crit Care Med. 2015;(43)5:1112-1120). Caregivers who are younger, female, minorities, and those with pre-existing depression are at especially high risk for worse mental health outcomes (Davidson et al; Cameron et al).


Caregivers of ICU survivors are vulnerable and undersupported. Interventions such as ICU diaries, telephone-based mindfulness exercises, and stress management strategies have shown promise in alleviating PICS-F symptoms (Choi et al.). During the acute ICU stay, how medical providers communicate, and how we help family members make sense of what has happened and their new roles as caregivers have an impact (Davidson et al.). From an individual in a study of psychosocial morbidity in caregivers of ICU survivors: “Leaving the hospital is not the end for some people. The next place is just as hard, sometimes worse” (Haines et al. Further studies are needed to identify interventions that will truly address this population’s unique needs.

Margaret Pisani, MD, FCCP

Steering Committee Member

Nicole Bournival, MD

Fellow-in-Training Member

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The tragic weaponization of health care

The Syrian conflict has highlighted the dangers to health-care workers (HCWs) in humanitarian crises. The Lancet-American University of Beirut Commission on Syria reports on the weaponization of health care in Syria – a strategy of depriving people of their health-care needs. Targeting of HCWs was recognized early in the Syrian war with targeting of health-care facilities being frequently reported throughout the conflict. HCWs facing extreme supply shortages have been reported to resort to desperate measures: using urine bags with added anticoagulants for blood collection and crafting homemade external fixators for fractures. Sadly, the Syrian conflict is not unique. The International Committee of the Red Cross (ICRC) documented 2,398 episodes of violence directed at health facilities in 11 countries affected by armed conflict between 2012 and 2014 alone. In Syria and elsewhere, the exodus of trained medical personnel, due to lack of medical training in trauma, emergency medicine, and intensive care, puts populations at further risk in these regions. The Inte

rnational Red Cross and Red Crescent Movement has started the Health Care in Danger (http://http://healthcareindanger.org) initiative to highlight this weaponization of health, supporting efforts by HCWs to advocate for their rights and their patients’ rights at a global level. This highlights the needs for CHEST members responding to humanitarian crises to ensure they have appropriate training to work in these environments and deploy with an organization that can provide adequate safeguards.

Dr. Maves is a military service member. The opinions expressed herein are his own and do not necessarily reflect the official opinions of the Department of the Navy, Department of Defense, or the US Government.

Rashmi Mishra, MD

Fellow-in-Training Member

Ryan Maves, MD, FCCP


Steering Committee Member

The House AHCA /Senate BCRA compared with ACA (Affordable Care Act)

Health-care costs are a fundamental driver of insurance costs, which leads to challenges to coverage affordability for millions of families. There is ongoing debate whether the current law (Affordable Care Act [ACA/Obamacare]) and the republican alternatives (American Healthcare Act [AHCA] and Better Care Reconciliation Act [BCRA]) do enough to address the cost challenges. Here is a brief summary of the key similarities and differences.

Similarities: (1) Children will be covered up to age 26. (2) Coverage of pre-existing conditions continues (high risk pools will be subsidized by a state government but premiums are up to twice as much as individual coverage). (3) Tax credit (based on age and family size rather than income level). (4) Insurance can charge older customers more than younger (up to 3X under ACA, 5X under AHCA/BCRA). (5) No annual or lifetime payout limit (but states may apply waivers allowing insurers to apply limits).

Differences: (1) Insurance will no longer be mandatory (no individual or employer mandates, but there is a 30% increase in premiums for 1 year for not maintaining individual continuous coverage). (2) Medicaid expansion (expanded under ACA to 133% of po

verty level income) will stop in 2020. (3) Restriction on “Abortion Funding” (any facility that offers abortion will not receive federal funding) for 1 year. (4) Taxes on health care will be removed (including taxes on prescription drugs, OTC, premiums, and medical devices). (5) Allowing policies for major illness or injury (with elimination of the requirement to cover ten essential health benefits, allowing states to modify).

Health-care reform undoubtedly is complicated, and there are a lot of questions in the air about the future of health care under the Trump Administration. Few certainties: change is coming, MACRA is here to stay.

Adel Bassily-Marcus, MD, FCCP

NetWork Chair

Posttraumatic Stress Disorder Post-Lung Transplant

The majority of transplant physicians are mainly concerned with issues posttransplant that are focused on the graft function. But recently, neurocognition and posttransplant posttraumatic stress disorder have been found to have significant impact on quality of life and mortality after transplantation. Posttraumatic stress disorder (PTSD) is described as re-experiencing a traumatic event in addition to having avoidant and hyperarousal symptoms, which last for a period of at least 1 month. Studies of PTSD in solid organ transplant recipients have revealed a significantly higher prevalence of PTSD symptoms (10% to 17%) compared with the general population (prevalence of 3.5% to 6%). In one study of heart transplant recipients, patients who met the criteria for PTSD in the first year posttransplant had a higher risk for 3-year mortality (OR=13.74) [Dew et al. J Heart Lung Transplant. 1999;18[6]:549-562].

Lung transplant recipients are at a high risk for developing PTSD due to exposure to several traumatic events, such as a life-threatening exacerbation of the underlying lung disease, undergoing transplant surgery, intensive care unit stay, delirium and episodes of infection, and acute and chronic rejection. However, data regarding the prevalence and risk factors for PTSD post-lung transplant are limited.

The prevalence of PTSD post lung transplantation has been reported to be 12.6% to 15.8%. In lung transplant recipients with clinically significant PTSD symptomatology; the presence of symptoms of re-experiencing (29.5%) and arousal (33.8%) were more common than avoidant symptoms (18.4%) [Gries et al. J Heart Lung Transplant. 2013; 32[5]: 525-532]. In another study by Dew et al, in 178 lung transplant recipients, all PTSD occurred in the early months posttransplant with a median duration of symptoms of 12 months (IQR 7.2 to 18.5 months) [Dew et al. Gen. Hosp Psychiatry. 2012;34:127-138]. A higher burden of PTSD is noted in patients who are younger, have a lo

wer income, have a previous history of a traumatic event, and have bronchiolitis obliterans (Gries et al. J Heart Lung Transplant. 2013;32[5]:525-532).

The challenges that remain include determining the true prevalence of PTSD in the lung transplant recipient in the LAS era using standard diagnostic criteria, documenting the adverse effects of PTSD on medical compliance, morbidity, and mortality; and developing interventions to mitigate the adverse effects of PTSD through well-designed multicenter prospective studies.

 

 

Vivek Ahya, MD

Steering Committee Member

Caregiver Burden in the ICU and Beyond

Family members of patients in the ICU who transition to the role of caregivers following discharge are at high risk for psychosocial distress. Post-intensive care syndrome-family (PICS-F) describes the symptoms of depression, posttraumatic stress, and anxiety commonly found in this population (Davidson et al. Crit Care Med. 2012;4(2):618-624). Women are more commonly called upon to adopt the role of caregiver for family members with chronic medical conditions or mental illnesses. Worldwide estimates indicate that 57% to 81% of all caregivers are women (Sharma et al. World J Psych. 2016;6[2]:7-17).

Family burden begins during the acute phase of critical illness. As surrogate decision-makers, they frequently face decisional conflict and decisional regret, especially in scenarios that limit life-sustaining therapies (Long et al. Curr Opin Crit Care. 2016;22:613-620). The prevalence of PICS-F is high as family members attempt to balance their role in the ICU with personal obligations (Choi et al. J Korean Acad Nurs. 2016;[46]2:159-167). Those who perceive that they are not receiving complete information from the medical team, and who do not find their physician comforting, have been shown to suffer a greater symptom burden (Davidson et al).

With the growing older adult population, and increased ICU survival, family members are often called upon to serve as caretakers to the chronically critically ill (Choi et al.). These caregivers have more depressive symptoms, worse health outcomes, and significant professional and personal lifestyle disruptions (Cameron, et al. N Engl J Med. 2016;[374]19:1831-1841). In many caregivers, depressive symptoms persist at 1 year after ICU admission, with rates comparable to caretakers of patients with dementia (Haines et al. Crit Care Med. 2015;(43)5:1112-1120). Caregivers who are younger, female, minorities, and those with pre-existing depression are at especially high risk for worse mental health outcomes (Davidson et al; Cameron et al).


Caregivers of ICU survivors are vulnerable and undersupported. Interventions such as ICU diaries, telephone-based mindfulness exercises, and stress management strategies have shown promise in alleviating PICS-F symptoms (Choi et al.). During the acute ICU stay, how medical providers communicate, and how we help family members make sense of what has happened and their new roles as caregivers have an impact (Davidson et al.). From an individual in a study of psychosocial morbidity in caregivers of ICU survivors: “Leaving the hospital is not the end for some people. The next place is just as hard, sometimes worse” (Haines et al. Further studies are needed to identify interventions that will truly address this population’s unique needs.

Margaret Pisani, MD, FCCP

Steering Committee Member

Nicole Bournival, MD

Fellow-in-Training Member

 

The tragic weaponization of health care

The Syrian conflict has highlighted the dangers to health-care workers (HCWs) in humanitarian crises. The Lancet-American University of Beirut Commission on Syria reports on the weaponization of health care in Syria – a strategy of depriving people of their health-care needs. Targeting of HCWs was recognized early in the Syrian war with targeting of health-care facilities being frequently reported throughout the conflict. HCWs facing extreme supply shortages have been reported to resort to desperate measures: using urine bags with added anticoagulants for blood collection and crafting homemade external fixators for fractures. Sadly, the Syrian conflict is not unique. The International Committee of the Red Cross (ICRC) documented 2,398 episodes of violence directed at health facilities in 11 countries affected by armed conflict between 2012 and 2014 alone. In Syria and elsewhere, the exodus of trained medical personnel, due to lack of medical training in trauma, emergency medicine, and intensive care, puts populations at further risk in these regions. The Inte

rnational Red Cross and Red Crescent Movement has started the Health Care in Danger (http://http://healthcareindanger.org) initiative to highlight this weaponization of health, supporting efforts by HCWs to advocate for their rights and their patients’ rights at a global level. This highlights the needs for CHEST members responding to humanitarian crises to ensure they have appropriate training to work in these environments and deploy with an organization that can provide adequate safeguards.

Dr. Maves is a military service member. The opinions expressed herein are his own and do not necessarily reflect the official opinions of the Department of the Navy, Department of Defense, or the US Government.

Rashmi Mishra, MD

Fellow-in-Training Member

Ryan Maves, MD, FCCP


Steering Committee Member

The House AHCA /Senate BCRA compared with ACA (Affordable Care Act)

Health-care costs are a fundamental driver of insurance costs, which leads to challenges to coverage affordability for millions of families. There is ongoing debate whether the current law (Affordable Care Act [ACA/Obamacare]) and the republican alternatives (American Healthcare Act [AHCA] and Better Care Reconciliation Act [BCRA]) do enough to address the cost challenges. Here is a brief summary of the key similarities and differences.

Similarities: (1) Children will be covered up to age 26. (2) Coverage of pre-existing conditions continues (high risk pools will be subsidized by a state government but premiums are up to twice as much as individual coverage). (3) Tax credit (based on age and family size rather than income level). (4) Insurance can charge older customers more than younger (up to 3X under ACA, 5X under AHCA/BCRA). (5) No annual or lifetime payout limit (but states may apply waivers allowing insurers to apply limits).

Differences: (1) Insurance will no longer be mandatory (no individual or employer mandates, but there is a 30% increase in premiums for 1 year for not maintaining individual continuous coverage). (2) Medicaid expansion (expanded under ACA to 133% of po

verty level income) will stop in 2020. (3) Restriction on “Abortion Funding” (any facility that offers abortion will not receive federal funding) for 1 year. (4) Taxes on health care will be removed (including taxes on prescription drugs, OTC, premiums, and medical devices). (5) Allowing policies for major illness or injury (with elimination of the requirement to cover ten essential health benefits, allowing states to modify).

Health-care reform undoubtedly is complicated, and there are a lot of questions in the air about the future of health care under the Trump Administration. Few certainties: change is coming, MACRA is here to stay.

Adel Bassily-Marcus, MD, FCCP

NetWork Chair

Posttraumatic Stress Disorder Post-Lung Transplant

The majority of transplant physicians are mainly concerned with issues posttransplant that are focused on the graft function. But recently, neurocognition and posttransplant posttraumatic stress disorder have been found to have significant impact on quality of life and mortality after transplantation. Posttraumatic stress disorder (PTSD) is described as re-experiencing a traumatic event in addition to having avoidant and hyperarousal symptoms, which last for a period of at least 1 month. Studies of PTSD in solid organ transplant recipients have revealed a significantly higher prevalence of PTSD symptoms (10% to 17%) compared with the general population (prevalence of 3.5% to 6%). In one study of heart transplant recipients, patients who met the criteria for PTSD in the first year posttransplant had a higher risk for 3-year mortality (OR=13.74) [Dew et al. J Heart Lung Transplant. 1999;18[6]:549-562].

Lung transplant recipients are at a high risk for developing PTSD due to exposure to several traumatic events, such as a life-threatening exacerbation of the underlying lung disease, undergoing transplant surgery, intensive care unit stay, delirium and episodes of infection, and acute and chronic rejection. However, data regarding the prevalence and risk factors for PTSD post-lung transplant are limited.

The prevalence of PTSD post lung transplantation has been reported to be 12.6% to 15.8%. In lung transplant recipients with clinically significant PTSD symptomatology; the presence of symptoms of re-experiencing (29.5%) and arousal (33.8%) were more common than avoidant symptoms (18.4%) [Gries et al. J Heart Lung Transplant. 2013; 32[5]: 525-532]. In another study by Dew et al, in 178 lung transplant recipients, all PTSD occurred in the early months posttransplant with a median duration of symptoms of 12 months (IQR 7.2 to 18.5 months) [Dew et al. Gen. Hosp Psychiatry. 2012;34:127-138]. A higher burden of PTSD is noted in patients who are younger, have a lo

wer income, have a previous history of a traumatic event, and have bronchiolitis obliterans (Gries et al. J Heart Lung Transplant. 2013;32[5]:525-532).

The challenges that remain include determining the true prevalence of PTSD in the lung transplant recipient in the LAS era using standard diagnostic criteria, documenting the adverse effects of PTSD on medical compliance, morbidity, and mortality; and developing interventions to mitigate the adverse effects of PTSD through well-designed multicenter prospective studies.

 

 

Vivek Ahya, MD

Steering Committee Member

Caregiver Burden in the ICU and Beyond

Family members of patients in the ICU who transition to the role of caregivers following discharge are at high risk for psychosocial distress. Post-intensive care syndrome-family (PICS-F) describes the symptoms of depression, posttraumatic stress, and anxiety commonly found in this population (Davidson et al. Crit Care Med. 2012;4(2):618-624). Women are more commonly called upon to adopt the role of caregiver for family members with chronic medical conditions or mental illnesses. Worldwide estimates indicate that 57% to 81% of all caregivers are women (Sharma et al. World J Psych. 2016;6[2]:7-17).

Family burden begins during the acute phase of critical illness. As surrogate decision-makers, they frequently face decisional conflict and decisional regret, especially in scenarios that limit life-sustaining therapies (Long et al. Curr Opin Crit Care. 2016;22:613-620). The prevalence of PICS-F is high as family members attempt to balance their role in the ICU with personal obligations (Choi et al. J Korean Acad Nurs. 2016;[46]2:159-167). Those who perceive that they are not receiving complete information from the medical team, and who do not find their physician comforting, have been shown to suffer a greater symptom burden (Davidson et al).

With the growing older adult population, and increased ICU survival, family members are often called upon to serve as caretakers to the chronically critically ill (Choi et al.). These caregivers have more depressive symptoms, worse health outcomes, and significant professional and personal lifestyle disruptions (Cameron, et al. N Engl J Med. 2016;[374]19:1831-1841). In many caregivers, depressive symptoms persist at 1 year after ICU admission, with rates comparable to caretakers of patients with dementia (Haines et al. Crit Care Med. 2015;(43)5:1112-1120). Caregivers who are younger, female, minorities, and those with pre-existing depression are at especially high risk for worse mental health outcomes (Davidson et al; Cameron et al).


Caregivers of ICU survivors are vulnerable and undersupported. Interventions such as ICU diaries, telephone-based mindfulness exercises, and stress management strategies have shown promise in alleviating PICS-F symptoms (Choi et al.). During the acute ICU stay, how medical providers communicate, and how we help family members make sense of what has happened and their new roles as caregivers have an impact (Davidson et al.). From an individual in a study of psychosocial morbidity in caregivers of ICU survivors: “Leaving the hospital is not the end for some people. The next place is just as hard, sometimes worse” (Haines et al. Further studies are needed to identify interventions that will truly address this population’s unique needs.

Margaret Pisani, MD, FCCP

Steering Committee Member

Nicole Bournival, MD

Fellow-in-Training Member

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High-flow nasal cannula safe outside of pediatric ICU, but may up length of stay

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– Young children with acute bronchiolitis do not need to be admitted to the pediatric ICU for high-flow nasal cannula treatment of up to 6 L/min and 50% oxygen; it is safe to administer it on the floor, according to a review of 6,804 acute bronchiolitis cases in children younger than 2 years treated at the University of Texas Southwestern Medical Center, Dallas.

Use of high-flow nasal cannulas (HFNC) has increased dramatically in recent years at UT Southwestern and elsewhere. It soothes children and can rapidly improve breathing without the nasal edema and nose bleeds common with cooler, drier, 100% oxygen. At Southwestern, HFNC use on the pediatric wards increased from 5% of acute bronchiolitis cases in the September 2010 to April 2011 season to 60% in the 2015-2016 season. Use for bronchiolitis in the PICU increased from 82% to 98% over the same period.

Dr. Vineeta Mittal


The increase correlated with a drop in intubation for acute bronchiolitis from 14% of children in 2010-2011 to just 2% in 2015-2016. The only HFNC adverse events were minor air leaks in two children.

As HFNC became more common, however, the Dallas team found that length of stay for acute bronchiolitis increased from 1.8 days in 2011-2012 to 2.4 days in 2015-2016, perhaps because the use of HFNC gives providers the impression that children are sicker than they actually are.

To counter the problem, lead investigator Vineeta Mittal, MD, associate professor of pediatrics, and her colleagues created an HFNC weaning protocol that gradually steps down treatment based on blood oxygen saturation levels and breathing effort, leading ultimately to a room-air challenge. It helped; the mean length of stay as of November 2016 was 1.7 days.

There’s been pushback in some places about giving HFNC on the floor: Intensivists sometimes consider it a form of ventilation that should be administered in the PICU. At levels up to 6 L/min and 50% oxygen, though, HFNC is “safe to give on the floor, because there’s no pneumothorax risk,” Dr. Mittal explained. HFNC “is not a ventilator; it’s an effective form of noninvasive respiratory support in children with moderate to severe respiratory distress from bronchiolitis.”

At Southwestern, “we are managing 80% of cases on the floor” with the help of HFNC, Dr. Mittal said at Pediatric Hospital Medicine.

At least for now, children at Southwestern go to the PICU if they need higher flow rates, but Dr. Mittal said it’s not clear if that’s necessary. “We said [6 L/min] is safe,” but maybe “we could even use 8 L/min or even 12 L/min” – the maximum delivered in the PICU over the study period – “because we know it’s safe,” she said. In addition, keeping kids on the floor also saves money, she noted at the meeting, which was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Dr. Mittal is concerned HFNC might be overused. “We have gotten so used to this machine that the moment we see distress, we put the kid on high flow,” rather than observing them for a bit to see if they recover on their own. More data are needed to determine when HFNC should be initiated, and when to pull the plug on HFNC and intubate, she said.

Dr. Mittal had no disclosures.

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– Young children with acute bronchiolitis do not need to be admitted to the pediatric ICU for high-flow nasal cannula treatment of up to 6 L/min and 50% oxygen; it is safe to administer it on the floor, according to a review of 6,804 acute bronchiolitis cases in children younger than 2 years treated at the University of Texas Southwestern Medical Center, Dallas.

Use of high-flow nasal cannulas (HFNC) has increased dramatically in recent years at UT Southwestern and elsewhere. It soothes children and can rapidly improve breathing without the nasal edema and nose bleeds common with cooler, drier, 100% oxygen. At Southwestern, HFNC use on the pediatric wards increased from 5% of acute bronchiolitis cases in the September 2010 to April 2011 season to 60% in the 2015-2016 season. Use for bronchiolitis in the PICU increased from 82% to 98% over the same period.

Dr. Vineeta Mittal


The increase correlated with a drop in intubation for acute bronchiolitis from 14% of children in 2010-2011 to just 2% in 2015-2016. The only HFNC adverse events were minor air leaks in two children.

As HFNC became more common, however, the Dallas team found that length of stay for acute bronchiolitis increased from 1.8 days in 2011-2012 to 2.4 days in 2015-2016, perhaps because the use of HFNC gives providers the impression that children are sicker than they actually are.

To counter the problem, lead investigator Vineeta Mittal, MD, associate professor of pediatrics, and her colleagues created an HFNC weaning protocol that gradually steps down treatment based on blood oxygen saturation levels and breathing effort, leading ultimately to a room-air challenge. It helped; the mean length of stay as of November 2016 was 1.7 days.

There’s been pushback in some places about giving HFNC on the floor: Intensivists sometimes consider it a form of ventilation that should be administered in the PICU. At levels up to 6 L/min and 50% oxygen, though, HFNC is “safe to give on the floor, because there’s no pneumothorax risk,” Dr. Mittal explained. HFNC “is not a ventilator; it’s an effective form of noninvasive respiratory support in children with moderate to severe respiratory distress from bronchiolitis.”

At Southwestern, “we are managing 80% of cases on the floor” with the help of HFNC, Dr. Mittal said at Pediatric Hospital Medicine.

At least for now, children at Southwestern go to the PICU if they need higher flow rates, but Dr. Mittal said it’s not clear if that’s necessary. “We said [6 L/min] is safe,” but maybe “we could even use 8 L/min or even 12 L/min” – the maximum delivered in the PICU over the study period – “because we know it’s safe,” she said. In addition, keeping kids on the floor also saves money, she noted at the meeting, which was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Dr. Mittal is concerned HFNC might be overused. “We have gotten so used to this machine that the moment we see distress, we put the kid on high flow,” rather than observing them for a bit to see if they recover on their own. More data are needed to determine when HFNC should be initiated, and when to pull the plug on HFNC and intubate, she said.

Dr. Mittal had no disclosures.

 

– Young children with acute bronchiolitis do not need to be admitted to the pediatric ICU for high-flow nasal cannula treatment of up to 6 L/min and 50% oxygen; it is safe to administer it on the floor, according to a review of 6,804 acute bronchiolitis cases in children younger than 2 years treated at the University of Texas Southwestern Medical Center, Dallas.

Use of high-flow nasal cannulas (HFNC) has increased dramatically in recent years at UT Southwestern and elsewhere. It soothes children and can rapidly improve breathing without the nasal edema and nose bleeds common with cooler, drier, 100% oxygen. At Southwestern, HFNC use on the pediatric wards increased from 5% of acute bronchiolitis cases in the September 2010 to April 2011 season to 60% in the 2015-2016 season. Use for bronchiolitis in the PICU increased from 82% to 98% over the same period.

Dr. Vineeta Mittal


The increase correlated with a drop in intubation for acute bronchiolitis from 14% of children in 2010-2011 to just 2% in 2015-2016. The only HFNC adverse events were minor air leaks in two children.

As HFNC became more common, however, the Dallas team found that length of stay for acute bronchiolitis increased from 1.8 days in 2011-2012 to 2.4 days in 2015-2016, perhaps because the use of HFNC gives providers the impression that children are sicker than they actually are.

To counter the problem, lead investigator Vineeta Mittal, MD, associate professor of pediatrics, and her colleagues created an HFNC weaning protocol that gradually steps down treatment based on blood oxygen saturation levels and breathing effort, leading ultimately to a room-air challenge. It helped; the mean length of stay as of November 2016 was 1.7 days.

There’s been pushback in some places about giving HFNC on the floor: Intensivists sometimes consider it a form of ventilation that should be administered in the PICU. At levels up to 6 L/min and 50% oxygen, though, HFNC is “safe to give on the floor, because there’s no pneumothorax risk,” Dr. Mittal explained. HFNC “is not a ventilator; it’s an effective form of noninvasive respiratory support in children with moderate to severe respiratory distress from bronchiolitis.”

At Southwestern, “we are managing 80% of cases on the floor” with the help of HFNC, Dr. Mittal said at Pediatric Hospital Medicine.

At least for now, children at Southwestern go to the PICU if they need higher flow rates, but Dr. Mittal said it’s not clear if that’s necessary. “We said [6 L/min] is safe,” but maybe “we could even use 8 L/min or even 12 L/min” – the maximum delivered in the PICU over the study period – “because we know it’s safe,” she said. In addition, keeping kids on the floor also saves money, she noted at the meeting, which was sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

Dr. Mittal is concerned HFNC might be overused. “We have gotten so used to this machine that the moment we see distress, we put the kid on high flow,” rather than observing them for a bit to see if they recover on their own. More data are needed to determine when HFNC should be initiated, and when to pull the plug on HFNC and intubate, she said.

Dr. Mittal had no disclosures.

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Key clinical point: Children don’t need to be in the PICU for high-flow nasal cannula treatment, at least up to a certain level – but it’s probably necessary to establish a weaning protocol so they don’t stay on it too long.

Major finding: The increased use of HFNC corresponded with an increase in length of stay for acute bronchiolitis, from 1.8 days in the 2011-2012 season to 2.4 days in the 2015-2016 season.

Data source: A single-center review of almost 7,000 acute bronchiolitis cases.

Disclosures: The lead investigator had no disclosures.

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Learn What's New in Billing, Coding

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Learn the latest in billing, coding and reimbursement at the 2017 Coding and Reimbursement Workshop for vascular surgeons, Oct. 13-14 in Chicago.

Cost is $880 for SVS members or staff; $955 for non-members and $250 for residents and trainees.

The program will address and review 2018 updates and include information about the global surgical package and how it impacts billing and reimbursement, along with the application of modifiers for streamlined reimbursement.

An optional workshop on Evaluation and Management (E&M) coding will be held from 9 a.m. to noon Oct. 13.

Learn more and register here

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Learn the latest in billing, coding and reimbursement at the 2017 Coding and Reimbursement Workshop for vascular surgeons, Oct. 13-14 in Chicago.

Cost is $880 for SVS members or staff; $955 for non-members and $250 for residents and trainees.

The program will address and review 2018 updates and include information about the global surgical package and how it impacts billing and reimbursement, along with the application of modifiers for streamlined reimbursement.

An optional workshop on Evaluation and Management (E&M) coding will be held from 9 a.m. to noon Oct. 13.

Learn more and register here

Learn the latest in billing, coding and reimbursement at the 2017 Coding and Reimbursement Workshop for vascular surgeons, Oct. 13-14 in Chicago.

Cost is $880 for SVS members or staff; $955 for non-members and $250 for residents and trainees.

The program will address and review 2018 updates and include information about the global surgical package and how it impacts billing and reimbursement, along with the application of modifiers for streamlined reimbursement.

An optional workshop on Evaluation and Management (E&M) coding will be held from 9 a.m. to noon Oct. 13.

Learn more and register here

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Impact of Displaying Inpatient Pharmaceutical Costs at the Time of Order Entry: Lessons From a Tertiary Care Center

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Impact of Displaying Inpatient Pharmaceutical Costs at the Time of Order Entry: Lessons From a Tertiary Care Center

Secondary to rising healthcare costs in the United States, broad efforts are underway to identify and reduce waste in the health system.1,2 A recent systematic review exhibited that many physicians inaccurately estimate the cost of medications.3 Raising awareness of medication costs among prescribers is one potential way to promote high-value care.

Some evidence suggests that cost transparency may help prescribers understand how medication orders drive costs. In a previous study carried out at the Johns Hopkins Hospital, fee data were displayed to providers for diagnostic laboratory tests.4 An 8.6% decrease (95% confidence interval [CI], –8.99% to –8.19%) in test ordering was observed when costs were displayed vs a 5.6% increase (95% CI, 4.90% to 6.39%) in ordering when costs were not displayed during a 6-month intervention period (P < 0.001). Conversely, a similar study that investigated the impact of cost transparency on inpatient imaging utilization did not demonstrate a significant influence of cost display.5 This suggests that cost transparency may work in some areas of care but not in others. A systematic review that investigated price-display interventions for imaging, laboratory studies, and medications reported 10 studies that demonstrated a statistically significant decrease in expenditures without an effect on patient safety.6

Informing prescribers of institution-specific medication costs within and between drug classes may enable the selection of less expensive, therapeutically equivalent drugs. Prior studies investigating the effect of medication cost display were conducted in a variety of patient care settings, including ambulatory clinics,7 urgent care centers,8 and operating rooms,9,10 with some yielding positive results in terms of ordering and cost11,12 and others having no impact.13,14 Currently, there is little evidence specifically addressing the effect of cost display for medications in the inpatient setting.

As part of an institutional initiative to control pharmaceutical expenditures, informational messaging for several high-cost drugs was initiated at our tertiary care hospital in April 2015. The goal of our study was to assess the effect of these medication cost messages on ordering practices. We hypothesized that the display of inpatient pharmaceutical costs at the time of order entry would result in a reduction in ordering.

METHODS

Setting, Intervention, and Participants

As part of an effort to educate prescribers about the high cost of medications, 9 intravenous (IV) medications were selected by the Johns Hopkins Hospital Pharmacy and Therapeutics Committee as targets for drug cost messaging. The intention of the committee was to implement a rapid, low-cost, proof-of-concept, quality-improvement project that was not designed as prospective research. Representatives from the pharmacy and clinicians from relevant clinical areas participated in preimplementation discussions to help identify medications that were subjectively felt to be overused at our institution and potentially modifiable through provider education. The criteria for selecting drug targets included a variety of factors, such as medications infrequently ordered but representing a significant cost per dose (eg, eculizumab and ribavirin), frequently ordered medications with less expensive substitutes (eg, linezolid and voriconazole), and high-cost medications without direct therapeutic alternatives (eg, calcitonin). From April 10, 2015, to October 5, 2015, the computerized Provider Order Entry System (cPOE), Sunrise Clinical Manager (Allscripts Corporation, Chicago, IL), displayed the cost for targeted medications. Seven of the medication alerts also included a reasonable therapeutic alternative and its cost. There were no restrictions placed on ordering; prescribers were able to choose the high-cost medications at their discretion.

Despite the fact that this initiative was not designed as a research project, we felt it was important to formally evaluate the impact of the drug cost messaging effort to inform future quality-improvement interventions. Each medication was compared to its preintervention baseline utilization dating back to January 1, 2013. For the 7 medications with alternatives offered, we also analyzed use of the suggested alternative during these time periods.

Data Sources and Measurement

Our study utilized data obtained from the pharmacy order verification system and the cPOE database. Data were collected over a period of 143 weeks from January 1, 2013, to October 5, 2015, to allow for a baseline period (January 1, 2013, to April 9, 2015) and an intervention period (April 10, 2015, to October 5, 2015). Data elements extracted included drug characteristics (dosage form, route, cost, strength, name, and quantity), patient characteristics (race, gender, and age), clinical setting (facility location, inpatient or outpatient), and billing information (provider name, doses dispensed from pharmacy, order number, revenue or procedure code, record number, date of service, and unique billing number) for each admission. Using these elements, we generated the following 8 variables to use in our analyses: week, month, period identifier, drug name, dosage form, weekly orders, weekly patient days, and number of weekly orders per 10,000 patient days. Average wholesale price (AWP), referred to as medication cost in this manuscript, was used to report all drug costs in all associated cost calculations. While the actual cost of acquisition and price charged to the patient may vary based on several factors, including manufacturer and payer, we chose to use AWP as a generalizable estimate of the cost of acquisition of the drug for the hospital.

 

 

Variables

“Week” and “month” were defined as the week and month of our study, respectively. The “period identifier” was a binary variable that identified the time period before and after the intervention. “Weekly orders” was defined as the total number of new orders placed per week for each specified drug included in our study. For example, if a patient received 2 discrete, new orders for a medication in a given week, 2 orders would be counted toward the “weekly orders” variable. “Patient days,” defined as the total number of patients treated at our facility, was summated for each week of our study to yield “weekly patient days.” To derive the “number of weekly orders per 10,000 patient days,” we divided weekly orders by weekly patient days and multiplied the resultant figure by 10,000.

Statistical Analysis

Segmented regression, a form of interrupted time series analysis, is a quasi-experimental design that was used to determine the immediate and sustained effects of the drug cost messages on the rate of medication ordering.15-17 The model enabled the use of comparison groups (alternative medications, as described above) to enhance internal validity.

In time series data, outcomes may not be independent over time. Autocorrelation of the error terms can arise when outcomes are more similar at time points closer together than outcomes at time points further apart. Failure to account for autocorrelation of the error terms may lead to underestimated standard errors. The presence of autocorrelation, assessed by calculating the Durbin-Watson statistic, was significant among our data. To adjust for this, we employed a Prais-Winsten estimation to adjust the error term (εt) calculated in our models.

Two segmented linear regression models were used to estimate trends in ordering before and after the intervention. The presence or absence of a comparator drug determined which model was to be used. When only single medications were under study, as in the case of eculizumab and calcitonin, our regression model was as follows:

Yt = (β0) + (β1)(Timet) + (β2)(Interventiont) + (β3)(Post-Intervention Timet) + (εt)

In our single-drug model, Yt denoted the number of orders per 10,000 patient days at week “t”; Timet was a continuous variable that indicated the number of weeks prior to or after the study intervention (April 10, 2015) and ranged from –116 to 27 weeks. Post-Intervention Timet was a continuous variable that denoted the number of weeks since the start of the intervention and is coded as zero for all time periods prior to the intervention. β0 was the estimated baseline number of orders per 10,000 patient days at the beginning of the study. β1 is the trend of orders per 10,000 patient days per week during the preintervention period; β2 represents an estimate of the change in the number of orders per 10,000 patient days immediately after the intervention; β3 denotes the difference between preintervention and postintervention slopes; and εt is the “error term,” which represents autocorrelation and random variability of the data.

As mentioned previously, alternative dosage forms of 7 medications included in our study were utilized as comparison groups. In these instances (when multiple drugs were included in our analyses), the following regression model was applied:

Y t = ( β 0 ) + ( β 1 )(Time t ) + ( β 2 )(Intervention t ) + ( β 3 )(Post-Intervention Time t ) + ( β 4 )(Cohort) + ( β 5 )(Cohort)(Time t ) + ( β 6 )(Cohort)(Intervention t ) + ( β 7 )(Cohort)(Post-Intervention Time t ) + ( ε t )

 

 

Here, 3 coefficients were added (β4-β7) to describe an additional cohort of orders. Cohort, a binary indicator variable, held a value of either 0 or 1 when the model was used to describe the treatment or comparison group, respectively. The coefficients β4-β7 described the treatment group, and β0-β3 described the comparison group. β4 was the difference in the number of baseline orders per 10,000 patient days between treatment and comparison groups; Β5 represented the difference between the estimated ordering trends of treatment and comparison groups; and Β6 indicated the difference in immediate changes in the number of orders per 10,000 patient days in the 2 groups following the intervention.

The number of orders per week was recorded for each medicine, which enabled a large number of data points to be included in our analyses. This allowed for more accurate and stable estimates to be made in our regression model. A total of 143 data points were collected for each study group, 116 before and 27 following each intervention.

All analyses were conducted by using STATA version 13.1 (StataCorp LP, College Station, TX).

RESULTS

Initial results pertaining to 9 IV medications were examined (Table). Following the implementation of cost messaging, no significant changes were observed in order frequency or trend for IV formulations of eculizumab, calcitonin, levetiracetam, linezolid, mycophenolate, ribavirin, voriconazole, and levothyroxine (Figures 1 and 2). However, a significant decrease in the number of oral ribavirin orders (Figure 2), the control group for the IV form, was observed (–16.3 orders per 10,000 patient days; P = .004; 95% CI, –27.2 to –5.31).

From March 26, 2015, to January 21, 2016, the use of IV pantoprazole was restricted at our facility due to a national shortage, requiring clinical pharmacy review and approval. Additionally, on September 15, 2014, oncology order sets that allowed antibiotic prescribing without an infectious disease provider’s approval replaced oral voriconazole with oral posaconazole. Consequently, both IV pantoprazole and oral voriconazole exhibited a sharp, sustained decrease in ordering following these policy changes (Figure 3). Although an apparent difference in ordering followed the policy changes, no significant change was noted in IV pantoprazole and oral voriconazole following our intervention.

DISCUSSION

Our results suggest that the passive strategy of displaying cost alone was not effective in altering prescriber ordering patterns for the selected medications. This may be due to a lack of awareness regarding direct financial impact on the patient, importance of costs in medical decision-making, or a perceived lack of alternatives or suitability of recommended alternatives. These results may prove valuable to hospital and pharmacy leadership as they develop strategies to curb medication expense.

Changes observed in IV pantoprazole ordering are instructive. Due to a national shortage, the IV form of this medication underwent a restriction, which required approval by the pharmacy prior to dispensing. This restriction was instituted independently of our study and led to a 73% decrease from usage rates prior to policy implementation (Figure 3). Ordering was restricted according to defined criteria for IV use. The restriction did not apply to oral pantoprazole, and no significant change in ordering of the oral formulation was noted during the evaluated period (Figure 3).

Oral voriconazole also exhibited a marked reduction in ordering of 46% following a change in hospital formulary that occurred independent of our study. The change in formulary involved a replacement of oral voriconazole with oral posaconazole in several oncology order sets, allowing antifungal administration without authorization by an infectious disease clinician. A dramatic reduction in ordering resulted from the removal of oral voriconazole from these order sets. Figure 3 represents the effect of the policy change on ordering. The frequency of orders for IV voriconazole, which was the target of our study intervention, did not change during this period (Figure 3).

The dramatic effect of policy changes, as observed with pantoprazole and voriconazole, suggests that a more active strategy may have a greater impact on prescriber behavior when it comes to medication ordering in the inpatient setting. It also highlights several potential sources of confounding that may introduce bias to cost-transparency studies.

This study has multiple limitations. First, as with all observational study designs, causation cannot be drawn with certainty from our results. While we were able to compare medications to their preintervention baselines, the data could have been impacted by longitudinal or seasonal trends in medication ordering, which may have been impacted by seasonal variability in disease prevalence, changes in resistance patterns, and annual cycling of house staff in an academic medical center. While there appear to be potential seasonal patterns regarding prescribing patterns for some of the medications included in this analysis, we also believe the linear regressions capture the overall trends in prescribing adequately. Nonstationarity, or trends in the mean and variance of the outcome that are not related to the intervention, may introduce bias in the interpretation of our findings. However, we believe the parameters included in our models, namely the immediate change in the intercept following the intervention and the change in the trend of the rate of prescribing over time from pre- to postintervention, provide substantial protections from faulty interpretation. Our models are limited to the extent that these parameters do not account for nonstationarity. Additionally, we did not collect data on dosing frequency or duration of treatment, which would have been dependent on factors that are not readily quantified, such as indication, clinical rationale, or patient response. Thus, we were not able to evaluate the impact of the intervention on these factors.

Although intended to enhance internal validity, comparison groups were also subject to external influence. For example, we observed a significant, short-lived rise in oral ribavirin (a control medication) ordering during the preintervention baseline period that appeared to be independent of our intervention and may speak to the unaccounted-for longitudinal variability detailed above.

Finally, the clinical indication and setting may be important. Previous studies performed at the same hospital with price displays showed a reduction in laboratory ordering but no change in imaging.18,19 One might speculate that ordering fewer laboratory tests is viewed by providers as eliminating waste rather than choosing a less expensive option to accomplish the same diagnostic task at hand. Therapeutics may be more similar to radiology tests, because patients presumably need the treatment and often do not have the option of simply not ordering without a concerted effort to reevaluate the treatment plan. Additionally, in a tertiary care teaching center such as ours, a junior clinician, oftentimes at the behest of a more senior colleague, enters most orders. In an environment in which the ordering prescriber has more autonomy or when the order is driven by a junior practitioner rather than an attending (such as daily laboratories), results may be different. Additionally, institutions that incentivize prescribers directly to practice cost-conscious care may experience different results from similar interventions.

We conclude that, in the case of medication cost messaging, a strategy of displaying cost information alone was insufficient to affect prescriber ordering behavior. Coupling cost transparency with educational interventions and active stewardship to impact clinical practice is worthy of further study.

 

 

Disclosures: The authors state that there were no external sponsors for this work. The Johns Hopkins Hospital and University “funded” this work by paying the salaries of the authors. The author team maintained independence and made all decisions regarding the study design, data collection, data analysis, interpretation of results, writing of the research report, and decision to submit it for publication. Dr. Shermock had full access to all the study data and takes responsibility for the integrity of the data and accuracy of the data analysis.

References

1. Berwick DM, Hackbarth AD. Eliminating Waste in US Health Care. JAMA. 2012;307(14):1513-1516. PubMed
2. PricewaterhouseCoopers’ Health Research Institute. The Price of Excess: Identifying Waste in Healthcare Spending. http://www.pwc.com/us/en/healthcare/publications/the-price-of-excess.html. Accessed June 17, 2015.
3. Allan GM, Lexchin J, Wiebe N. Physician awareness of drug cost: a systematic review. PLoS Med. 2007;4(9):e283. PubMed
4. Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908. PubMed
5. Durand DJ, Feldman LS, Lewin JS, Brotman DJ. Provider cost transparency alone has no impact on inpatient imaging utilization. J Am Coll Radiol. 2013;10(2):108-113. PubMed
6. Silvestri MT, Bongiovanni TR, Glover JG, Gross CP. Impact of price display on provider ordering: A systematic review. J Hosp Med. 2016;11(1):65-76. PubMed
7. Ornstein SM, MacFarlane LL, Jenkins RG, Pan Q, Wager KA. Medication cost information in a computer-based patient record system. Impact on prescribing in a family medicine clinical practice. Arch Fam Med. 1999;8(2):118-121. PubMed
8. Guterman JJ, Chernof BA, Mares B, Gross-Schulman SG, Gan PG, Thomas D. Modifying provider behavior: A low-tech approach to pharmaceutical ordering. J Gen Intern Med. 2002;17(10):792-796. PubMed
9. McNitt JD, Bode ET, Nelson RE. Long-term pharmaceutical cost reduction using a data management system. Anesth Analg. 1998;87(4):837-842. PubMed
10. Horrow JC, Rosenberg H. Price stickers do not alter drug usage. Can J Anaesth. 1994;41(11):1047-1052. PubMed
11. Guterman JJ, Chernof BA, Mares B, Gross-Schulman SG, Gan PG, Thomas D. Modifying provider behavior: A low-tech approach to pharmaceutical ordering. J Gen Intern Med. 2002;17(10):792-796. PubMed
12. McNitt JD, Bode ET, Nelson RE. Long-term pharmaceutical cost reduction using a data management system. Anesth Analg. 1998;87(4):837-842. PubMed
13. Ornstein SM, MacFarlane LL, Jenkins RG, Pan Q, Wager KA. Medication cost information in a computer-based patient record system. Impact on prescribing in a family medicine clinical practice. Arch Fam Med. 1999;8(2):118-121. PubMed
14. Horrow JC, Rosenberg H. Price stickers do not alter drug usage. Can J Anaesth. 1994;41(11):1047-1052. PubMed
15. Jandoc R, Burden AM, Mamdani M, Levesque LE, Cadarette SM. Interrupted time series analysis in drug utilization research is increasing: Systematic review and recommendations. J Clin Epidemiol. 2015;68(8):950-56. PubMed
16. Linden A. Conducting interrupted time-series analysis for single- and multiple-group comparisons. Stata J. 2015;15(2):480-500. 
17. Linden A, Adams JL. Applying a propensity score-based weighting model to interrupted time series data: improving causal inference in programme evaluation. J Eval Clin Pract. 2011;17(6):1231-1238. PubMed
18. Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908. PubMed
19. Durand DJ, Feldman LS, Lewin JS, Brotman DJ. Provider cost transparency alone has no impact on inpatient imaging utilization. J Am Coll Radiol. 2013;10(2):108-113. PubMed

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Secondary to rising healthcare costs in the United States, broad efforts are underway to identify and reduce waste in the health system.1,2 A recent systematic review exhibited that many physicians inaccurately estimate the cost of medications.3 Raising awareness of medication costs among prescribers is one potential way to promote high-value care.

Some evidence suggests that cost transparency may help prescribers understand how medication orders drive costs. In a previous study carried out at the Johns Hopkins Hospital, fee data were displayed to providers for diagnostic laboratory tests.4 An 8.6% decrease (95% confidence interval [CI], –8.99% to –8.19%) in test ordering was observed when costs were displayed vs a 5.6% increase (95% CI, 4.90% to 6.39%) in ordering when costs were not displayed during a 6-month intervention period (P < 0.001). Conversely, a similar study that investigated the impact of cost transparency on inpatient imaging utilization did not demonstrate a significant influence of cost display.5 This suggests that cost transparency may work in some areas of care but not in others. A systematic review that investigated price-display interventions for imaging, laboratory studies, and medications reported 10 studies that demonstrated a statistically significant decrease in expenditures without an effect on patient safety.6

Informing prescribers of institution-specific medication costs within and between drug classes may enable the selection of less expensive, therapeutically equivalent drugs. Prior studies investigating the effect of medication cost display were conducted in a variety of patient care settings, including ambulatory clinics,7 urgent care centers,8 and operating rooms,9,10 with some yielding positive results in terms of ordering and cost11,12 and others having no impact.13,14 Currently, there is little evidence specifically addressing the effect of cost display for medications in the inpatient setting.

As part of an institutional initiative to control pharmaceutical expenditures, informational messaging for several high-cost drugs was initiated at our tertiary care hospital in April 2015. The goal of our study was to assess the effect of these medication cost messages on ordering practices. We hypothesized that the display of inpatient pharmaceutical costs at the time of order entry would result in a reduction in ordering.

METHODS

Setting, Intervention, and Participants

As part of an effort to educate prescribers about the high cost of medications, 9 intravenous (IV) medications were selected by the Johns Hopkins Hospital Pharmacy and Therapeutics Committee as targets for drug cost messaging. The intention of the committee was to implement a rapid, low-cost, proof-of-concept, quality-improvement project that was not designed as prospective research. Representatives from the pharmacy and clinicians from relevant clinical areas participated in preimplementation discussions to help identify medications that were subjectively felt to be overused at our institution and potentially modifiable through provider education. The criteria for selecting drug targets included a variety of factors, such as medications infrequently ordered but representing a significant cost per dose (eg, eculizumab and ribavirin), frequently ordered medications with less expensive substitutes (eg, linezolid and voriconazole), and high-cost medications without direct therapeutic alternatives (eg, calcitonin). From April 10, 2015, to October 5, 2015, the computerized Provider Order Entry System (cPOE), Sunrise Clinical Manager (Allscripts Corporation, Chicago, IL), displayed the cost for targeted medications. Seven of the medication alerts also included a reasonable therapeutic alternative and its cost. There were no restrictions placed on ordering; prescribers were able to choose the high-cost medications at their discretion.

Despite the fact that this initiative was not designed as a research project, we felt it was important to formally evaluate the impact of the drug cost messaging effort to inform future quality-improvement interventions. Each medication was compared to its preintervention baseline utilization dating back to January 1, 2013. For the 7 medications with alternatives offered, we also analyzed use of the suggested alternative during these time periods.

Data Sources and Measurement

Our study utilized data obtained from the pharmacy order verification system and the cPOE database. Data were collected over a period of 143 weeks from January 1, 2013, to October 5, 2015, to allow for a baseline period (January 1, 2013, to April 9, 2015) and an intervention period (April 10, 2015, to October 5, 2015). Data elements extracted included drug characteristics (dosage form, route, cost, strength, name, and quantity), patient characteristics (race, gender, and age), clinical setting (facility location, inpatient or outpatient), and billing information (provider name, doses dispensed from pharmacy, order number, revenue or procedure code, record number, date of service, and unique billing number) for each admission. Using these elements, we generated the following 8 variables to use in our analyses: week, month, period identifier, drug name, dosage form, weekly orders, weekly patient days, and number of weekly orders per 10,000 patient days. Average wholesale price (AWP), referred to as medication cost in this manuscript, was used to report all drug costs in all associated cost calculations. While the actual cost of acquisition and price charged to the patient may vary based on several factors, including manufacturer and payer, we chose to use AWP as a generalizable estimate of the cost of acquisition of the drug for the hospital.

 

 

Variables

“Week” and “month” were defined as the week and month of our study, respectively. The “period identifier” was a binary variable that identified the time period before and after the intervention. “Weekly orders” was defined as the total number of new orders placed per week for each specified drug included in our study. For example, if a patient received 2 discrete, new orders for a medication in a given week, 2 orders would be counted toward the “weekly orders” variable. “Patient days,” defined as the total number of patients treated at our facility, was summated for each week of our study to yield “weekly patient days.” To derive the “number of weekly orders per 10,000 patient days,” we divided weekly orders by weekly patient days and multiplied the resultant figure by 10,000.

Statistical Analysis

Segmented regression, a form of interrupted time series analysis, is a quasi-experimental design that was used to determine the immediate and sustained effects of the drug cost messages on the rate of medication ordering.15-17 The model enabled the use of comparison groups (alternative medications, as described above) to enhance internal validity.

In time series data, outcomes may not be independent over time. Autocorrelation of the error terms can arise when outcomes are more similar at time points closer together than outcomes at time points further apart. Failure to account for autocorrelation of the error terms may lead to underestimated standard errors. The presence of autocorrelation, assessed by calculating the Durbin-Watson statistic, was significant among our data. To adjust for this, we employed a Prais-Winsten estimation to adjust the error term (εt) calculated in our models.

Two segmented linear regression models were used to estimate trends in ordering before and after the intervention. The presence or absence of a comparator drug determined which model was to be used. When only single medications were under study, as in the case of eculizumab and calcitonin, our regression model was as follows:

Yt = (β0) + (β1)(Timet) + (β2)(Interventiont) + (β3)(Post-Intervention Timet) + (εt)

In our single-drug model, Yt denoted the number of orders per 10,000 patient days at week “t”; Timet was a continuous variable that indicated the number of weeks prior to or after the study intervention (April 10, 2015) and ranged from –116 to 27 weeks. Post-Intervention Timet was a continuous variable that denoted the number of weeks since the start of the intervention and is coded as zero for all time periods prior to the intervention. β0 was the estimated baseline number of orders per 10,000 patient days at the beginning of the study. β1 is the trend of orders per 10,000 patient days per week during the preintervention period; β2 represents an estimate of the change in the number of orders per 10,000 patient days immediately after the intervention; β3 denotes the difference between preintervention and postintervention slopes; and εt is the “error term,” which represents autocorrelation and random variability of the data.

As mentioned previously, alternative dosage forms of 7 medications included in our study were utilized as comparison groups. In these instances (when multiple drugs were included in our analyses), the following regression model was applied:

Y t = ( β 0 ) + ( β 1 )(Time t ) + ( β 2 )(Intervention t ) + ( β 3 )(Post-Intervention Time t ) + ( β 4 )(Cohort) + ( β 5 )(Cohort)(Time t ) + ( β 6 )(Cohort)(Intervention t ) + ( β 7 )(Cohort)(Post-Intervention Time t ) + ( ε t )

 

 

Here, 3 coefficients were added (β4-β7) to describe an additional cohort of orders. Cohort, a binary indicator variable, held a value of either 0 or 1 when the model was used to describe the treatment or comparison group, respectively. The coefficients β4-β7 described the treatment group, and β0-β3 described the comparison group. β4 was the difference in the number of baseline orders per 10,000 patient days between treatment and comparison groups; Β5 represented the difference between the estimated ordering trends of treatment and comparison groups; and Β6 indicated the difference in immediate changes in the number of orders per 10,000 patient days in the 2 groups following the intervention.

The number of orders per week was recorded for each medicine, which enabled a large number of data points to be included in our analyses. This allowed for more accurate and stable estimates to be made in our regression model. A total of 143 data points were collected for each study group, 116 before and 27 following each intervention.

All analyses were conducted by using STATA version 13.1 (StataCorp LP, College Station, TX).

RESULTS

Initial results pertaining to 9 IV medications were examined (Table). Following the implementation of cost messaging, no significant changes were observed in order frequency or trend for IV formulations of eculizumab, calcitonin, levetiracetam, linezolid, mycophenolate, ribavirin, voriconazole, and levothyroxine (Figures 1 and 2). However, a significant decrease in the number of oral ribavirin orders (Figure 2), the control group for the IV form, was observed (–16.3 orders per 10,000 patient days; P = .004; 95% CI, –27.2 to –5.31).

From March 26, 2015, to January 21, 2016, the use of IV pantoprazole was restricted at our facility due to a national shortage, requiring clinical pharmacy review and approval. Additionally, on September 15, 2014, oncology order sets that allowed antibiotic prescribing without an infectious disease provider’s approval replaced oral voriconazole with oral posaconazole. Consequently, both IV pantoprazole and oral voriconazole exhibited a sharp, sustained decrease in ordering following these policy changes (Figure 3). Although an apparent difference in ordering followed the policy changes, no significant change was noted in IV pantoprazole and oral voriconazole following our intervention.

DISCUSSION

Our results suggest that the passive strategy of displaying cost alone was not effective in altering prescriber ordering patterns for the selected medications. This may be due to a lack of awareness regarding direct financial impact on the patient, importance of costs in medical decision-making, or a perceived lack of alternatives or suitability of recommended alternatives. These results may prove valuable to hospital and pharmacy leadership as they develop strategies to curb medication expense.

Changes observed in IV pantoprazole ordering are instructive. Due to a national shortage, the IV form of this medication underwent a restriction, which required approval by the pharmacy prior to dispensing. This restriction was instituted independently of our study and led to a 73% decrease from usage rates prior to policy implementation (Figure 3). Ordering was restricted according to defined criteria for IV use. The restriction did not apply to oral pantoprazole, and no significant change in ordering of the oral formulation was noted during the evaluated period (Figure 3).

Oral voriconazole also exhibited a marked reduction in ordering of 46% following a change in hospital formulary that occurred independent of our study. The change in formulary involved a replacement of oral voriconazole with oral posaconazole in several oncology order sets, allowing antifungal administration without authorization by an infectious disease clinician. A dramatic reduction in ordering resulted from the removal of oral voriconazole from these order sets. Figure 3 represents the effect of the policy change on ordering. The frequency of orders for IV voriconazole, which was the target of our study intervention, did not change during this period (Figure 3).

The dramatic effect of policy changes, as observed with pantoprazole and voriconazole, suggests that a more active strategy may have a greater impact on prescriber behavior when it comes to medication ordering in the inpatient setting. It also highlights several potential sources of confounding that may introduce bias to cost-transparency studies.

This study has multiple limitations. First, as with all observational study designs, causation cannot be drawn with certainty from our results. While we were able to compare medications to their preintervention baselines, the data could have been impacted by longitudinal or seasonal trends in medication ordering, which may have been impacted by seasonal variability in disease prevalence, changes in resistance patterns, and annual cycling of house staff in an academic medical center. While there appear to be potential seasonal patterns regarding prescribing patterns for some of the medications included in this analysis, we also believe the linear regressions capture the overall trends in prescribing adequately. Nonstationarity, or trends in the mean and variance of the outcome that are not related to the intervention, may introduce bias in the interpretation of our findings. However, we believe the parameters included in our models, namely the immediate change in the intercept following the intervention and the change in the trend of the rate of prescribing over time from pre- to postintervention, provide substantial protections from faulty interpretation. Our models are limited to the extent that these parameters do not account for nonstationarity. Additionally, we did not collect data on dosing frequency or duration of treatment, which would have been dependent on factors that are not readily quantified, such as indication, clinical rationale, or patient response. Thus, we were not able to evaluate the impact of the intervention on these factors.

Although intended to enhance internal validity, comparison groups were also subject to external influence. For example, we observed a significant, short-lived rise in oral ribavirin (a control medication) ordering during the preintervention baseline period that appeared to be independent of our intervention and may speak to the unaccounted-for longitudinal variability detailed above.

Finally, the clinical indication and setting may be important. Previous studies performed at the same hospital with price displays showed a reduction in laboratory ordering but no change in imaging.18,19 One might speculate that ordering fewer laboratory tests is viewed by providers as eliminating waste rather than choosing a less expensive option to accomplish the same diagnostic task at hand. Therapeutics may be more similar to radiology tests, because patients presumably need the treatment and often do not have the option of simply not ordering without a concerted effort to reevaluate the treatment plan. Additionally, in a tertiary care teaching center such as ours, a junior clinician, oftentimes at the behest of a more senior colleague, enters most orders. In an environment in which the ordering prescriber has more autonomy or when the order is driven by a junior practitioner rather than an attending (such as daily laboratories), results may be different. Additionally, institutions that incentivize prescribers directly to practice cost-conscious care may experience different results from similar interventions.

We conclude that, in the case of medication cost messaging, a strategy of displaying cost information alone was insufficient to affect prescriber ordering behavior. Coupling cost transparency with educational interventions and active stewardship to impact clinical practice is worthy of further study.

 

 

Disclosures: The authors state that there were no external sponsors for this work. The Johns Hopkins Hospital and University “funded” this work by paying the salaries of the authors. The author team maintained independence and made all decisions regarding the study design, data collection, data analysis, interpretation of results, writing of the research report, and decision to submit it for publication. Dr. Shermock had full access to all the study data and takes responsibility for the integrity of the data and accuracy of the data analysis.

Secondary to rising healthcare costs in the United States, broad efforts are underway to identify and reduce waste in the health system.1,2 A recent systematic review exhibited that many physicians inaccurately estimate the cost of medications.3 Raising awareness of medication costs among prescribers is one potential way to promote high-value care.

Some evidence suggests that cost transparency may help prescribers understand how medication orders drive costs. In a previous study carried out at the Johns Hopkins Hospital, fee data were displayed to providers for diagnostic laboratory tests.4 An 8.6% decrease (95% confidence interval [CI], –8.99% to –8.19%) in test ordering was observed when costs were displayed vs a 5.6% increase (95% CI, 4.90% to 6.39%) in ordering when costs were not displayed during a 6-month intervention period (P < 0.001). Conversely, a similar study that investigated the impact of cost transparency on inpatient imaging utilization did not demonstrate a significant influence of cost display.5 This suggests that cost transparency may work in some areas of care but not in others. A systematic review that investigated price-display interventions for imaging, laboratory studies, and medications reported 10 studies that demonstrated a statistically significant decrease in expenditures without an effect on patient safety.6

Informing prescribers of institution-specific medication costs within and between drug classes may enable the selection of less expensive, therapeutically equivalent drugs. Prior studies investigating the effect of medication cost display were conducted in a variety of patient care settings, including ambulatory clinics,7 urgent care centers,8 and operating rooms,9,10 with some yielding positive results in terms of ordering and cost11,12 and others having no impact.13,14 Currently, there is little evidence specifically addressing the effect of cost display for medications in the inpatient setting.

As part of an institutional initiative to control pharmaceutical expenditures, informational messaging for several high-cost drugs was initiated at our tertiary care hospital in April 2015. The goal of our study was to assess the effect of these medication cost messages on ordering practices. We hypothesized that the display of inpatient pharmaceutical costs at the time of order entry would result in a reduction in ordering.

METHODS

Setting, Intervention, and Participants

As part of an effort to educate prescribers about the high cost of medications, 9 intravenous (IV) medications were selected by the Johns Hopkins Hospital Pharmacy and Therapeutics Committee as targets for drug cost messaging. The intention of the committee was to implement a rapid, low-cost, proof-of-concept, quality-improvement project that was not designed as prospective research. Representatives from the pharmacy and clinicians from relevant clinical areas participated in preimplementation discussions to help identify medications that were subjectively felt to be overused at our institution and potentially modifiable through provider education. The criteria for selecting drug targets included a variety of factors, such as medications infrequently ordered but representing a significant cost per dose (eg, eculizumab and ribavirin), frequently ordered medications with less expensive substitutes (eg, linezolid and voriconazole), and high-cost medications without direct therapeutic alternatives (eg, calcitonin). From April 10, 2015, to October 5, 2015, the computerized Provider Order Entry System (cPOE), Sunrise Clinical Manager (Allscripts Corporation, Chicago, IL), displayed the cost for targeted medications. Seven of the medication alerts also included a reasonable therapeutic alternative and its cost. There were no restrictions placed on ordering; prescribers were able to choose the high-cost medications at their discretion.

Despite the fact that this initiative was not designed as a research project, we felt it was important to formally evaluate the impact of the drug cost messaging effort to inform future quality-improvement interventions. Each medication was compared to its preintervention baseline utilization dating back to January 1, 2013. For the 7 medications with alternatives offered, we also analyzed use of the suggested alternative during these time periods.

Data Sources and Measurement

Our study utilized data obtained from the pharmacy order verification system and the cPOE database. Data were collected over a period of 143 weeks from January 1, 2013, to October 5, 2015, to allow for a baseline period (January 1, 2013, to April 9, 2015) and an intervention period (April 10, 2015, to October 5, 2015). Data elements extracted included drug characteristics (dosage form, route, cost, strength, name, and quantity), patient characteristics (race, gender, and age), clinical setting (facility location, inpatient or outpatient), and billing information (provider name, doses dispensed from pharmacy, order number, revenue or procedure code, record number, date of service, and unique billing number) for each admission. Using these elements, we generated the following 8 variables to use in our analyses: week, month, period identifier, drug name, dosage form, weekly orders, weekly patient days, and number of weekly orders per 10,000 patient days. Average wholesale price (AWP), referred to as medication cost in this manuscript, was used to report all drug costs in all associated cost calculations. While the actual cost of acquisition and price charged to the patient may vary based on several factors, including manufacturer and payer, we chose to use AWP as a generalizable estimate of the cost of acquisition of the drug for the hospital.

 

 

Variables

“Week” and “month” were defined as the week and month of our study, respectively. The “period identifier” was a binary variable that identified the time period before and after the intervention. “Weekly orders” was defined as the total number of new orders placed per week for each specified drug included in our study. For example, if a patient received 2 discrete, new orders for a medication in a given week, 2 orders would be counted toward the “weekly orders” variable. “Patient days,” defined as the total number of patients treated at our facility, was summated for each week of our study to yield “weekly patient days.” To derive the “number of weekly orders per 10,000 patient days,” we divided weekly orders by weekly patient days and multiplied the resultant figure by 10,000.

Statistical Analysis

Segmented regression, a form of interrupted time series analysis, is a quasi-experimental design that was used to determine the immediate and sustained effects of the drug cost messages on the rate of medication ordering.15-17 The model enabled the use of comparison groups (alternative medications, as described above) to enhance internal validity.

In time series data, outcomes may not be independent over time. Autocorrelation of the error terms can arise when outcomes are more similar at time points closer together than outcomes at time points further apart. Failure to account for autocorrelation of the error terms may lead to underestimated standard errors. The presence of autocorrelation, assessed by calculating the Durbin-Watson statistic, was significant among our data. To adjust for this, we employed a Prais-Winsten estimation to adjust the error term (εt) calculated in our models.

Two segmented linear regression models were used to estimate trends in ordering before and after the intervention. The presence or absence of a comparator drug determined which model was to be used. When only single medications were under study, as in the case of eculizumab and calcitonin, our regression model was as follows:

Yt = (β0) + (β1)(Timet) + (β2)(Interventiont) + (β3)(Post-Intervention Timet) + (εt)

In our single-drug model, Yt denoted the number of orders per 10,000 patient days at week “t”; Timet was a continuous variable that indicated the number of weeks prior to or after the study intervention (April 10, 2015) and ranged from –116 to 27 weeks. Post-Intervention Timet was a continuous variable that denoted the number of weeks since the start of the intervention and is coded as zero for all time periods prior to the intervention. β0 was the estimated baseline number of orders per 10,000 patient days at the beginning of the study. β1 is the trend of orders per 10,000 patient days per week during the preintervention period; β2 represents an estimate of the change in the number of orders per 10,000 patient days immediately after the intervention; β3 denotes the difference between preintervention and postintervention slopes; and εt is the “error term,” which represents autocorrelation and random variability of the data.

As mentioned previously, alternative dosage forms of 7 medications included in our study were utilized as comparison groups. In these instances (when multiple drugs were included in our analyses), the following regression model was applied:

Y t = ( β 0 ) + ( β 1 )(Time t ) + ( β 2 )(Intervention t ) + ( β 3 )(Post-Intervention Time t ) + ( β 4 )(Cohort) + ( β 5 )(Cohort)(Time t ) + ( β 6 )(Cohort)(Intervention t ) + ( β 7 )(Cohort)(Post-Intervention Time t ) + ( ε t )

 

 

Here, 3 coefficients were added (β4-β7) to describe an additional cohort of orders. Cohort, a binary indicator variable, held a value of either 0 or 1 when the model was used to describe the treatment or comparison group, respectively. The coefficients β4-β7 described the treatment group, and β0-β3 described the comparison group. β4 was the difference in the number of baseline orders per 10,000 patient days between treatment and comparison groups; Β5 represented the difference between the estimated ordering trends of treatment and comparison groups; and Β6 indicated the difference in immediate changes in the number of orders per 10,000 patient days in the 2 groups following the intervention.

The number of orders per week was recorded for each medicine, which enabled a large number of data points to be included in our analyses. This allowed for more accurate and stable estimates to be made in our regression model. A total of 143 data points were collected for each study group, 116 before and 27 following each intervention.

All analyses were conducted by using STATA version 13.1 (StataCorp LP, College Station, TX).

RESULTS

Initial results pertaining to 9 IV medications were examined (Table). Following the implementation of cost messaging, no significant changes were observed in order frequency or trend for IV formulations of eculizumab, calcitonin, levetiracetam, linezolid, mycophenolate, ribavirin, voriconazole, and levothyroxine (Figures 1 and 2). However, a significant decrease in the number of oral ribavirin orders (Figure 2), the control group for the IV form, was observed (–16.3 orders per 10,000 patient days; P = .004; 95% CI, –27.2 to –5.31).

From March 26, 2015, to January 21, 2016, the use of IV pantoprazole was restricted at our facility due to a national shortage, requiring clinical pharmacy review and approval. Additionally, on September 15, 2014, oncology order sets that allowed antibiotic prescribing without an infectious disease provider’s approval replaced oral voriconazole with oral posaconazole. Consequently, both IV pantoprazole and oral voriconazole exhibited a sharp, sustained decrease in ordering following these policy changes (Figure 3). Although an apparent difference in ordering followed the policy changes, no significant change was noted in IV pantoprazole and oral voriconazole following our intervention.

DISCUSSION

Our results suggest that the passive strategy of displaying cost alone was not effective in altering prescriber ordering patterns for the selected medications. This may be due to a lack of awareness regarding direct financial impact on the patient, importance of costs in medical decision-making, or a perceived lack of alternatives or suitability of recommended alternatives. These results may prove valuable to hospital and pharmacy leadership as they develop strategies to curb medication expense.

Changes observed in IV pantoprazole ordering are instructive. Due to a national shortage, the IV form of this medication underwent a restriction, which required approval by the pharmacy prior to dispensing. This restriction was instituted independently of our study and led to a 73% decrease from usage rates prior to policy implementation (Figure 3). Ordering was restricted according to defined criteria for IV use. The restriction did not apply to oral pantoprazole, and no significant change in ordering of the oral formulation was noted during the evaluated period (Figure 3).

Oral voriconazole also exhibited a marked reduction in ordering of 46% following a change in hospital formulary that occurred independent of our study. The change in formulary involved a replacement of oral voriconazole with oral posaconazole in several oncology order sets, allowing antifungal administration without authorization by an infectious disease clinician. A dramatic reduction in ordering resulted from the removal of oral voriconazole from these order sets. Figure 3 represents the effect of the policy change on ordering. The frequency of orders for IV voriconazole, which was the target of our study intervention, did not change during this period (Figure 3).

The dramatic effect of policy changes, as observed with pantoprazole and voriconazole, suggests that a more active strategy may have a greater impact on prescriber behavior when it comes to medication ordering in the inpatient setting. It also highlights several potential sources of confounding that may introduce bias to cost-transparency studies.

This study has multiple limitations. First, as with all observational study designs, causation cannot be drawn with certainty from our results. While we were able to compare medications to their preintervention baselines, the data could have been impacted by longitudinal or seasonal trends in medication ordering, which may have been impacted by seasonal variability in disease prevalence, changes in resistance patterns, and annual cycling of house staff in an academic medical center. While there appear to be potential seasonal patterns regarding prescribing patterns for some of the medications included in this analysis, we also believe the linear regressions capture the overall trends in prescribing adequately. Nonstationarity, or trends in the mean and variance of the outcome that are not related to the intervention, may introduce bias in the interpretation of our findings. However, we believe the parameters included in our models, namely the immediate change in the intercept following the intervention and the change in the trend of the rate of prescribing over time from pre- to postintervention, provide substantial protections from faulty interpretation. Our models are limited to the extent that these parameters do not account for nonstationarity. Additionally, we did not collect data on dosing frequency or duration of treatment, which would have been dependent on factors that are not readily quantified, such as indication, clinical rationale, or patient response. Thus, we were not able to evaluate the impact of the intervention on these factors.

Although intended to enhance internal validity, comparison groups were also subject to external influence. For example, we observed a significant, short-lived rise in oral ribavirin (a control medication) ordering during the preintervention baseline period that appeared to be independent of our intervention and may speak to the unaccounted-for longitudinal variability detailed above.

Finally, the clinical indication and setting may be important. Previous studies performed at the same hospital with price displays showed a reduction in laboratory ordering but no change in imaging.18,19 One might speculate that ordering fewer laboratory tests is viewed by providers as eliminating waste rather than choosing a less expensive option to accomplish the same diagnostic task at hand. Therapeutics may be more similar to radiology tests, because patients presumably need the treatment and often do not have the option of simply not ordering without a concerted effort to reevaluate the treatment plan. Additionally, in a tertiary care teaching center such as ours, a junior clinician, oftentimes at the behest of a more senior colleague, enters most orders. In an environment in which the ordering prescriber has more autonomy or when the order is driven by a junior practitioner rather than an attending (such as daily laboratories), results may be different. Additionally, institutions that incentivize prescribers directly to practice cost-conscious care may experience different results from similar interventions.

We conclude that, in the case of medication cost messaging, a strategy of displaying cost information alone was insufficient to affect prescriber ordering behavior. Coupling cost transparency with educational interventions and active stewardship to impact clinical practice is worthy of further study.

 

 

Disclosures: The authors state that there were no external sponsors for this work. The Johns Hopkins Hospital and University “funded” this work by paying the salaries of the authors. The author team maintained independence and made all decisions regarding the study design, data collection, data analysis, interpretation of results, writing of the research report, and decision to submit it for publication. Dr. Shermock had full access to all the study data and takes responsibility for the integrity of the data and accuracy of the data analysis.

References

1. Berwick DM, Hackbarth AD. Eliminating Waste in US Health Care. JAMA. 2012;307(14):1513-1516. PubMed
2. PricewaterhouseCoopers’ Health Research Institute. The Price of Excess: Identifying Waste in Healthcare Spending. http://www.pwc.com/us/en/healthcare/publications/the-price-of-excess.html. Accessed June 17, 2015.
3. Allan GM, Lexchin J, Wiebe N. Physician awareness of drug cost: a systematic review. PLoS Med. 2007;4(9):e283. PubMed
4. Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908. PubMed
5. Durand DJ, Feldman LS, Lewin JS, Brotman DJ. Provider cost transparency alone has no impact on inpatient imaging utilization. J Am Coll Radiol. 2013;10(2):108-113. PubMed
6. Silvestri MT, Bongiovanni TR, Glover JG, Gross CP. Impact of price display on provider ordering: A systematic review. J Hosp Med. 2016;11(1):65-76. PubMed
7. Ornstein SM, MacFarlane LL, Jenkins RG, Pan Q, Wager KA. Medication cost information in a computer-based patient record system. Impact on prescribing in a family medicine clinical practice. Arch Fam Med. 1999;8(2):118-121. PubMed
8. Guterman JJ, Chernof BA, Mares B, Gross-Schulman SG, Gan PG, Thomas D. Modifying provider behavior: A low-tech approach to pharmaceutical ordering. J Gen Intern Med. 2002;17(10):792-796. PubMed
9. McNitt JD, Bode ET, Nelson RE. Long-term pharmaceutical cost reduction using a data management system. Anesth Analg. 1998;87(4):837-842. PubMed
10. Horrow JC, Rosenberg H. Price stickers do not alter drug usage. Can J Anaesth. 1994;41(11):1047-1052. PubMed
11. Guterman JJ, Chernof BA, Mares B, Gross-Schulman SG, Gan PG, Thomas D. Modifying provider behavior: A low-tech approach to pharmaceutical ordering. J Gen Intern Med. 2002;17(10):792-796. PubMed
12. McNitt JD, Bode ET, Nelson RE. Long-term pharmaceutical cost reduction using a data management system. Anesth Analg. 1998;87(4):837-842. PubMed
13. Ornstein SM, MacFarlane LL, Jenkins RG, Pan Q, Wager KA. Medication cost information in a computer-based patient record system. Impact on prescribing in a family medicine clinical practice. Arch Fam Med. 1999;8(2):118-121. PubMed
14. Horrow JC, Rosenberg H. Price stickers do not alter drug usage. Can J Anaesth. 1994;41(11):1047-1052. PubMed
15. Jandoc R, Burden AM, Mamdani M, Levesque LE, Cadarette SM. Interrupted time series analysis in drug utilization research is increasing: Systematic review and recommendations. J Clin Epidemiol. 2015;68(8):950-56. PubMed
16. Linden A. Conducting interrupted time-series analysis for single- and multiple-group comparisons. Stata J. 2015;15(2):480-500. 
17. Linden A, Adams JL. Applying a propensity score-based weighting model to interrupted time series data: improving causal inference in programme evaluation. J Eval Clin Pract. 2011;17(6):1231-1238. PubMed
18. Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908. PubMed
19. Durand DJ, Feldman LS, Lewin JS, Brotman DJ. Provider cost transparency alone has no impact on inpatient imaging utilization. J Am Coll Radiol. 2013;10(2):108-113. PubMed

References

1. Berwick DM, Hackbarth AD. Eliminating Waste in US Health Care. JAMA. 2012;307(14):1513-1516. PubMed
2. PricewaterhouseCoopers’ Health Research Institute. The Price of Excess: Identifying Waste in Healthcare Spending. http://www.pwc.com/us/en/healthcare/publications/the-price-of-excess.html. Accessed June 17, 2015.
3. Allan GM, Lexchin J, Wiebe N. Physician awareness of drug cost: a systematic review. PLoS Med. 2007;4(9):e283. PubMed
4. Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908. PubMed
5. Durand DJ, Feldman LS, Lewin JS, Brotman DJ. Provider cost transparency alone has no impact on inpatient imaging utilization. J Am Coll Radiol. 2013;10(2):108-113. PubMed
6. Silvestri MT, Bongiovanni TR, Glover JG, Gross CP. Impact of price display on provider ordering: A systematic review. J Hosp Med. 2016;11(1):65-76. PubMed
7. Ornstein SM, MacFarlane LL, Jenkins RG, Pan Q, Wager KA. Medication cost information in a computer-based patient record system. Impact on prescribing in a family medicine clinical practice. Arch Fam Med. 1999;8(2):118-121. PubMed
8. Guterman JJ, Chernof BA, Mares B, Gross-Schulman SG, Gan PG, Thomas D. Modifying provider behavior: A low-tech approach to pharmaceutical ordering. J Gen Intern Med. 2002;17(10):792-796. PubMed
9. McNitt JD, Bode ET, Nelson RE. Long-term pharmaceutical cost reduction using a data management system. Anesth Analg. 1998;87(4):837-842. PubMed
10. Horrow JC, Rosenberg H. Price stickers do not alter drug usage. Can J Anaesth. 1994;41(11):1047-1052. PubMed
11. Guterman JJ, Chernof BA, Mares B, Gross-Schulman SG, Gan PG, Thomas D. Modifying provider behavior: A low-tech approach to pharmaceutical ordering. J Gen Intern Med. 2002;17(10):792-796. PubMed
12. McNitt JD, Bode ET, Nelson RE. Long-term pharmaceutical cost reduction using a data management system. Anesth Analg. 1998;87(4):837-842. PubMed
13. Ornstein SM, MacFarlane LL, Jenkins RG, Pan Q, Wager KA. Medication cost information in a computer-based patient record system. Impact on prescribing in a family medicine clinical practice. Arch Fam Med. 1999;8(2):118-121. PubMed
14. Horrow JC, Rosenberg H. Price stickers do not alter drug usage. Can J Anaesth. 1994;41(11):1047-1052. PubMed
15. Jandoc R, Burden AM, Mamdani M, Levesque LE, Cadarette SM. Interrupted time series analysis in drug utilization research is increasing: Systematic review and recommendations. J Clin Epidemiol. 2015;68(8):950-56. PubMed
16. Linden A. Conducting interrupted time-series analysis for single- and multiple-group comparisons. Stata J. 2015;15(2):480-500. 
17. Linden A, Adams JL. Applying a propensity score-based weighting model to interrupted time series data: improving causal inference in programme evaluation. J Eval Clin Pract. 2011;17(6):1231-1238. PubMed
18. Feldman LS, Shihab HM, Thiemann D, et al. Impact of providing fee data on laboratory test ordering: a controlled clinical trial. JAMA Intern Med. 2013;173(10):903-908. PubMed
19. Durand DJ, Feldman LS, Lewin JS, Brotman DJ. Provider cost transparency alone has no impact on inpatient imaging utilization. J Am Coll Radiol. 2013;10(2):108-113. PubMed

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The Long-Term Effect of Bacille Calmette-Guérin Vaccination on Tuberculin Skin Testing: A 55-Year Follow-Up Study By Dr. J. D. Mancuso, et al.

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Precision Medicine Urgency: The Case of Inhaled Corticosteroids in COPD By Drs. S. Suissa and P. Ernst

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Physician Assessment of Pretest Probability of Malignancy and Adherence With Guidelines for Pulmonary Nodule Evaluation By Dr. N. T. Tanner, et al.

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Members can now earn 10, 20, or 30 points for participating in eligible activities such as attending CHEST Annual Meeting, submitting abstracts, participating in a CHEST Twitter chat, becoming a Fellow of the American College of Chest Physicians (FCCP), and more!

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