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Eleven on a scale of 1 to 10
I literally rode into the sunset recently as I finished my tour of duty as one of the Director examiners for the American Board of Surgery. I was heading out of St. Louis westward toward my home in Kansas. It was a 9-hour drive, which gave me plenty of time to reflect on the 6 years I shared the responsibility of administering the certifying exam known by most surgeons as “the oral exam.”
Over the last dozen years, Directors V. Suzanne Klimberg and Karen J. Brasel, along with former Executive Director Frank Lewis, a team of psychometricians at the Board, and members of the certification committee of the Board, worked tirelessly to create a testing instrument as fair and statistically sound as possible given the inherently qualitative exam. I believe they did a magnificent job. Gone are the legends of yesteryear where candidates were subjected to the whims of whatever crossed the mind of the examiners, including their prejudices about the “right” answer. The oral exam now represents a well-constructed survey of surgical judgment issues that have been thoroughly vetted.
Being an examiner for the orals means you arrive Sunday afternoon before the exams that are given over the next two and a half days. Each examiner undergoes an overview briefing on Sunday afternoon and then studies “the book” for that test’s content usually until late into the night. This book is an impressive document.
We arise around 0530 to attend a breakfast meeting, which includes breaking into our six-person teams and going over each question that will be given that day. At 0800, the first candidates for the first session walk into a room and meet the two surgeons who will make some of the most important decisions affecting that candidate’s career. If you rate the intensity of this moment on a scale of 1 to 10, this is an 11 for both candidates and examiners. No one in the room knows how it will turn out because every session has its own twists and turns. Everyone there wants to see a passing score, but the two examiners know that they must make a decision that is safe for the public and fair for the candidate.
Twelve exams are given per team per day except for the final day which has only six. So, each team examines 30 candidates over 3 days. I’ve opened a door and shaken the moist hand of 438 candidates. I’ve seen every sort of emotion during those sessions. I’ve had moments of great joy and times of profound sadness as candidates respond to the questions. I’ve always tried to be friendly, but just like surgery, it is a serious business and decisions have to be made. That means ignoring one’s hopes and acting on the best facts available at the moment. Most surgeons remember their oral examiners and what they were asked for a lifetime. I know I do.
I could write a book on this experience (I won’t, though). But as I reflect on my time as a Director, what stands out in my mind are the associate examiners with whom I’ve worked. These surgeons are invited to participate and receive no compensation. It’s 3 days out of their lives, and because they don’t give the exam as frequently as the Directors do, the amount of study and effort is greater for them. Each is selected because he or she is considered to be a thoughtful surgeon with high standards. These surgeons do this job because they care about quality in our profession.
Most of the associates I have worked with are far more accomplished than I. I was once paired with a renowned breast surgeon (okay, it was Kelly K. Hunt). My ego was at great risk because I knew how accomplished she was. But like all the other associates, she was gracious and hard working. We rarely work with another Director, but Anne G. Rizzo, who later became a Director, and I did an exam together. She was a dazzling questioner with very high standards. In other words, she was typical of the people I met. My first associate (also later a Director) was Reid Adams. He was great; I was nervous. My last associate was Marc L. Melcher, a transplant surgeon who asked penetrating questions in a calm manner. I wish I could name each of my associates and thank them for making my work so much better, for teaching me things I didn’t know, for deepening my own knowledge, and serving in a hard job with grace. This column can’t be that long, but you all know who you are. Thank you.
At the end of the day, I believe the oral exam to be a great thing for our profession. When you think about the number of patients potentially affected throughout a surgeon’s career, the impact of decisions made on the day of the exam can be enormous. Given that, over a 20-year career, a surgeon may operate on 25,000 patients, a summative check on a surgeon’s judgment and knowledge is important. Each year, the ABS adjudicates on some 1,100 surgeons. A single year’s set of surgeons over the following 20-year period translates into 27.5 million patients. I hope we never stop doing the orals because of cost, time, or convenience. The exam is just too important to our profession to risk forgoing this last, big step before a surgeon is presented to the world as “certified.”
I literally rode into the sunset recently as I finished my tour of duty as one of the Director examiners for the American Board of Surgery. I was heading out of St. Louis westward toward my home in Kansas. It was a 9-hour drive, which gave me plenty of time to reflect on the 6 years I shared the responsibility of administering the certifying exam known by most surgeons as “the oral exam.”
Over the last dozen years, Directors V. Suzanne Klimberg and Karen J. Brasel, along with former Executive Director Frank Lewis, a team of psychometricians at the Board, and members of the certification committee of the Board, worked tirelessly to create a testing instrument as fair and statistically sound as possible given the inherently qualitative exam. I believe they did a magnificent job. Gone are the legends of yesteryear where candidates were subjected to the whims of whatever crossed the mind of the examiners, including their prejudices about the “right” answer. The oral exam now represents a well-constructed survey of surgical judgment issues that have been thoroughly vetted.
Being an examiner for the orals means you arrive Sunday afternoon before the exams that are given over the next two and a half days. Each examiner undergoes an overview briefing on Sunday afternoon and then studies “the book” for that test’s content usually until late into the night. This book is an impressive document.
We arise around 0530 to attend a breakfast meeting, which includes breaking into our six-person teams and going over each question that will be given that day. At 0800, the first candidates for the first session walk into a room and meet the two surgeons who will make some of the most important decisions affecting that candidate’s career. If you rate the intensity of this moment on a scale of 1 to 10, this is an 11 for both candidates and examiners. No one in the room knows how it will turn out because every session has its own twists and turns. Everyone there wants to see a passing score, but the two examiners know that they must make a decision that is safe for the public and fair for the candidate.
Twelve exams are given per team per day except for the final day which has only six. So, each team examines 30 candidates over 3 days. I’ve opened a door and shaken the moist hand of 438 candidates. I’ve seen every sort of emotion during those sessions. I’ve had moments of great joy and times of profound sadness as candidates respond to the questions. I’ve always tried to be friendly, but just like surgery, it is a serious business and decisions have to be made. That means ignoring one’s hopes and acting on the best facts available at the moment. Most surgeons remember their oral examiners and what they were asked for a lifetime. I know I do.
I could write a book on this experience (I won’t, though). But as I reflect on my time as a Director, what stands out in my mind are the associate examiners with whom I’ve worked. These surgeons are invited to participate and receive no compensation. It’s 3 days out of their lives, and because they don’t give the exam as frequently as the Directors do, the amount of study and effort is greater for them. Each is selected because he or she is considered to be a thoughtful surgeon with high standards. These surgeons do this job because they care about quality in our profession.
Most of the associates I have worked with are far more accomplished than I. I was once paired with a renowned breast surgeon (okay, it was Kelly K. Hunt). My ego was at great risk because I knew how accomplished she was. But like all the other associates, she was gracious and hard working. We rarely work with another Director, but Anne G. Rizzo, who later became a Director, and I did an exam together. She was a dazzling questioner with very high standards. In other words, she was typical of the people I met. My first associate (also later a Director) was Reid Adams. He was great; I was nervous. My last associate was Marc L. Melcher, a transplant surgeon who asked penetrating questions in a calm manner. I wish I could name each of my associates and thank them for making my work so much better, for teaching me things I didn’t know, for deepening my own knowledge, and serving in a hard job with grace. This column can’t be that long, but you all know who you are. Thank you.
At the end of the day, I believe the oral exam to be a great thing for our profession. When you think about the number of patients potentially affected throughout a surgeon’s career, the impact of decisions made on the day of the exam can be enormous. Given that, over a 20-year career, a surgeon may operate on 25,000 patients, a summative check on a surgeon’s judgment and knowledge is important. Each year, the ABS adjudicates on some 1,100 surgeons. A single year’s set of surgeons over the following 20-year period translates into 27.5 million patients. I hope we never stop doing the orals because of cost, time, or convenience. The exam is just too important to our profession to risk forgoing this last, big step before a surgeon is presented to the world as “certified.”
I literally rode into the sunset recently as I finished my tour of duty as one of the Director examiners for the American Board of Surgery. I was heading out of St. Louis westward toward my home in Kansas. It was a 9-hour drive, which gave me plenty of time to reflect on the 6 years I shared the responsibility of administering the certifying exam known by most surgeons as “the oral exam.”
Over the last dozen years, Directors V. Suzanne Klimberg and Karen J. Brasel, along with former Executive Director Frank Lewis, a team of psychometricians at the Board, and members of the certification committee of the Board, worked tirelessly to create a testing instrument as fair and statistically sound as possible given the inherently qualitative exam. I believe they did a magnificent job. Gone are the legends of yesteryear where candidates were subjected to the whims of whatever crossed the mind of the examiners, including their prejudices about the “right” answer. The oral exam now represents a well-constructed survey of surgical judgment issues that have been thoroughly vetted.
Being an examiner for the orals means you arrive Sunday afternoon before the exams that are given over the next two and a half days. Each examiner undergoes an overview briefing on Sunday afternoon and then studies “the book” for that test’s content usually until late into the night. This book is an impressive document.
We arise around 0530 to attend a breakfast meeting, which includes breaking into our six-person teams and going over each question that will be given that day. At 0800, the first candidates for the first session walk into a room and meet the two surgeons who will make some of the most important decisions affecting that candidate’s career. If you rate the intensity of this moment on a scale of 1 to 10, this is an 11 for both candidates and examiners. No one in the room knows how it will turn out because every session has its own twists and turns. Everyone there wants to see a passing score, but the two examiners know that they must make a decision that is safe for the public and fair for the candidate.
Twelve exams are given per team per day except for the final day which has only six. So, each team examines 30 candidates over 3 days. I’ve opened a door and shaken the moist hand of 438 candidates. I’ve seen every sort of emotion during those sessions. I’ve had moments of great joy and times of profound sadness as candidates respond to the questions. I’ve always tried to be friendly, but just like surgery, it is a serious business and decisions have to be made. That means ignoring one’s hopes and acting on the best facts available at the moment. Most surgeons remember their oral examiners and what they were asked for a lifetime. I know I do.
I could write a book on this experience (I won’t, though). But as I reflect on my time as a Director, what stands out in my mind are the associate examiners with whom I’ve worked. These surgeons are invited to participate and receive no compensation. It’s 3 days out of their lives, and because they don’t give the exam as frequently as the Directors do, the amount of study and effort is greater for them. Each is selected because he or she is considered to be a thoughtful surgeon with high standards. These surgeons do this job because they care about quality in our profession.
Most of the associates I have worked with are far more accomplished than I. I was once paired with a renowned breast surgeon (okay, it was Kelly K. Hunt). My ego was at great risk because I knew how accomplished she was. But like all the other associates, she was gracious and hard working. We rarely work with another Director, but Anne G. Rizzo, who later became a Director, and I did an exam together. She was a dazzling questioner with very high standards. In other words, she was typical of the people I met. My first associate (also later a Director) was Reid Adams. He was great; I was nervous. My last associate was Marc L. Melcher, a transplant surgeon who asked penetrating questions in a calm manner. I wish I could name each of my associates and thank them for making my work so much better, for teaching me things I didn’t know, for deepening my own knowledge, and serving in a hard job with grace. This column can’t be that long, but you all know who you are. Thank you.
At the end of the day, I believe the oral exam to be a great thing for our profession. When you think about the number of patients potentially affected throughout a surgeon’s career, the impact of decisions made on the day of the exam can be enormous. Given that, over a 20-year career, a surgeon may operate on 25,000 patients, a summative check on a surgeon’s judgment and knowledge is important. Each year, the ABS adjudicates on some 1,100 surgeons. A single year’s set of surgeons over the following 20-year period translates into 27.5 million patients. I hope we never stop doing the orals because of cost, time, or convenience. The exam is just too important to our profession to risk forgoing this last, big step before a surgeon is presented to the world as “certified.”
June 2018 Question 2
Correct answer: C
Rationale
This patient has long-standing diabetes with associated complications from prolonged hyperglycemia, with symptoms of delayed gastric emptying. The next best step would be to perform a gastric-emptying study or scintigraphy to confirm the diagnosis of diabetic gastroparesis. A dietitian consult will be necessary once gastroparesis is confirmed, since dietary modifications are the mainstay of treatment. Strict blood glucose control is necessary to prevent worsening gastrointestinal symptoms, and an evaluation by an endocrinologist is reasonable if gastroparesis is confirmed. A trial of metoclopramide may be necessary if gastroparesis symptoms are not controlled with dietary modifications, but it would not be first-line treatment in diabetic gastroparesis.
References
1. Camilleri M. Advances in diabetic gastroparesis. Rev Gastroenterol Disord. 2002;2:47-56.
2. Camilleri M, Vazquez-Roque MI. Gastric dysmotility at the organ level in gastroparesis. In: Parkman H, McCallum R. Gastroparesis: Pathophysiology, presentation, diagnosis, and treatment. New York: Springer; 2011. p. 37-46.
Correct answer: C
Rationale
This patient has long-standing diabetes with associated complications from prolonged hyperglycemia, with symptoms of delayed gastric emptying. The next best step would be to perform a gastric-emptying study or scintigraphy to confirm the diagnosis of diabetic gastroparesis. A dietitian consult will be necessary once gastroparesis is confirmed, since dietary modifications are the mainstay of treatment. Strict blood glucose control is necessary to prevent worsening gastrointestinal symptoms, and an evaluation by an endocrinologist is reasonable if gastroparesis is confirmed. A trial of metoclopramide may be necessary if gastroparesis symptoms are not controlled with dietary modifications, but it would not be first-line treatment in diabetic gastroparesis.
References
1. Camilleri M. Advances in diabetic gastroparesis. Rev Gastroenterol Disord. 2002;2:47-56.
2. Camilleri M, Vazquez-Roque MI. Gastric dysmotility at the organ level in gastroparesis. In: Parkman H, McCallum R. Gastroparesis: Pathophysiology, presentation, diagnosis, and treatment. New York: Springer; 2011. p. 37-46.
Correct answer: C
Rationale
This patient has long-standing diabetes with associated complications from prolonged hyperglycemia, with symptoms of delayed gastric emptying. The next best step would be to perform a gastric-emptying study or scintigraphy to confirm the diagnosis of diabetic gastroparesis. A dietitian consult will be necessary once gastroparesis is confirmed, since dietary modifications are the mainstay of treatment. Strict blood glucose control is necessary to prevent worsening gastrointestinal symptoms, and an evaluation by an endocrinologist is reasonable if gastroparesis is confirmed. A trial of metoclopramide may be necessary if gastroparesis symptoms are not controlled with dietary modifications, but it would not be first-line treatment in diabetic gastroparesis.
References
1. Camilleri M. Advances in diabetic gastroparesis. Rev Gastroenterol Disord. 2002;2:47-56.
2. Camilleri M, Vazquez-Roque MI. Gastric dysmotility at the organ level in gastroparesis. In: Parkman H, McCallum R. Gastroparesis: Pathophysiology, presentation, diagnosis, and treatment. New York: Springer; 2011. p. 37-46.
A 55-year-old obese man with long-standing type 2 diabetes mellitus complains of nausea and early satiety for over a year. His medical history is significant for retinopathy, neuropathy, and nephropathy. His diabetes is treated with subcutaneous insulin and an oral hypoglycemic agent, but his recent glycosylated hemoglobin was 11.2%. Since the onset of symptoms, he has lost approximately 30 pounds. Recent upper endoscopy was normal.
June 2018 Question 1
Correct answer: C
Rationale
This patient is presenting early post-liver transplant with severe hepatic dysfunction. This severity of enzyme elevation is concerning for an underlying hepatic artery thrombosis. The next appropriate diagnostic test for this patient is a hepatic ultrasound with Dopplers to assess hepatic artery patency. CMV infection does not typically occur within the first month post-liver transplant and would not be expected to cause this degree of elevation in the liver enzymes. Performance of liver biopsy, MRCP, or ERCP would not reveal the underlying etiology and may result in delay in diagnosis.
Reference
1. Stange BJ, Glanemann M, Nuessler NC, et al. Hepatic artery thrombosis after adult liver transplantation. Liver Transplantation 2003;9:612-20.
Correct answer: C
Rationale
This patient is presenting early post-liver transplant with severe hepatic dysfunction. This severity of enzyme elevation is concerning for an underlying hepatic artery thrombosis. The next appropriate diagnostic test for this patient is a hepatic ultrasound with Dopplers to assess hepatic artery patency. CMV infection does not typically occur within the first month post-liver transplant and would not be expected to cause this degree of elevation in the liver enzymes. Performance of liver biopsy, MRCP, or ERCP would not reveal the underlying etiology and may result in delay in diagnosis.
Reference
1. Stange BJ, Glanemann M, Nuessler NC, et al. Hepatic artery thrombosis after adult liver transplantation. Liver Transplantation 2003;9:612-20.
Correct answer: C
Rationale
This patient is presenting early post-liver transplant with severe hepatic dysfunction. This severity of enzyme elevation is concerning for an underlying hepatic artery thrombosis. The next appropriate diagnostic test for this patient is a hepatic ultrasound with Dopplers to assess hepatic artery patency. CMV infection does not typically occur within the first month post-liver transplant and would not be expected to cause this degree of elevation in the liver enzymes. Performance of liver biopsy, MRCP, or ERCP would not reveal the underlying etiology and may result in delay in diagnosis.
Reference
1. Stange BJ, Glanemann M, Nuessler NC, et al. Hepatic artery thrombosis after adult liver transplantation. Liver Transplantation 2003;9:612-20.
A 62-year-old man underwent deceased-donor liver transplant 36 hours ago for decompensated chronic hepatitis C cirrhosis. He did well initially posttransplant with a steady decline in his transaminases and improvement in hepatic synthetic function. But he has had a rapidly progressive decline in his clinical status over the past 12 hours. On physical exam, his mental status is notable for new confusion. His temperature is 38.9 ºC. Laboratory data reveal the following:
AST 10,300 U/L
ALT 14,550 U/L
total bilirubin 9.6 mg/dL
alkaline phosphatase 693 IU/L
INR 3.6
creatinine 4.6 mg/dL with oliguria.
I’M NOT A PROVIDER
I am not sure when it occurred. I don’t know how it happened. I don’t think anyone took a vote on it. It happened gradually over the last decade. I think it happened when the administrative staff became larger than the medical staff. In order to include everyone under the same umbrella, everyone became a provider.
All those patients in our waiting room suddenly became consumers or clients. My grandfather ran a grocery store and had a lot of customers, and my father was a lawyer and had a lot of clients. None of those customers or clients would come to see me as their doctor with their illnesses today if I were a provider. The use of the terminology of “providers” and “customers” lowers all health care staff to the lowest common denominator and demeans the concerns of my patients.
I do not mean to diminish the role of the auto mechanic and salesperson, but they know and I know that our roles and are different and we are not just providers of a medical commodity. They do not expect me to deal with them as though they were coming to buy a car. They understand that we are actually trying to cure and treat worried patients and not to sell to customers in a show room.
This change in nomenclature that has permeated health care has had significant effects on how medical care is provided. Hospital care has been depersonalized in order to expedite hospital stays and maximize reimbursement. Gone is the hospital visit of your doctors when you need them the most.
Part of it is the complexity of contemporary care that requires the input from varying levels of expertise. Patients are often shuttled from one doctor to another. Communication is carried out through the web and rarely doctor to doctor. Often doctors are dealt with both at the patient level and the administrative level as commodities off the shelf, like buying a pair of shoes. And doctors in the hospital and in the clinic can be replaced by another one as the shift changes or the schedule dictates with little regard to the patient’s – or customer’s – choice.
Can we return to the days of yore? Probably not. All we can do now is try to inject some level of humanity and empathy as we see our patients in today’s world of mechanized medicine.
Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and the division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
I am not sure when it occurred. I don’t know how it happened. I don’t think anyone took a vote on it. It happened gradually over the last decade. I think it happened when the administrative staff became larger than the medical staff. In order to include everyone under the same umbrella, everyone became a provider.
All those patients in our waiting room suddenly became consumers or clients. My grandfather ran a grocery store and had a lot of customers, and my father was a lawyer and had a lot of clients. None of those customers or clients would come to see me as their doctor with their illnesses today if I were a provider. The use of the terminology of “providers” and “customers” lowers all health care staff to the lowest common denominator and demeans the concerns of my patients.
I do not mean to diminish the role of the auto mechanic and salesperson, but they know and I know that our roles and are different and we are not just providers of a medical commodity. They do not expect me to deal with them as though they were coming to buy a car. They understand that we are actually trying to cure and treat worried patients and not to sell to customers in a show room.
This change in nomenclature that has permeated health care has had significant effects on how medical care is provided. Hospital care has been depersonalized in order to expedite hospital stays and maximize reimbursement. Gone is the hospital visit of your doctors when you need them the most.
Part of it is the complexity of contemporary care that requires the input from varying levels of expertise. Patients are often shuttled from one doctor to another. Communication is carried out through the web and rarely doctor to doctor. Often doctors are dealt with both at the patient level and the administrative level as commodities off the shelf, like buying a pair of shoes. And doctors in the hospital and in the clinic can be replaced by another one as the shift changes or the schedule dictates with little regard to the patient’s – or customer’s – choice.
Can we return to the days of yore? Probably not. All we can do now is try to inject some level of humanity and empathy as we see our patients in today’s world of mechanized medicine.
Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and the division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
I am not sure when it occurred. I don’t know how it happened. I don’t think anyone took a vote on it. It happened gradually over the last decade. I think it happened when the administrative staff became larger than the medical staff. In order to include everyone under the same umbrella, everyone became a provider.
All those patients in our waiting room suddenly became consumers or clients. My grandfather ran a grocery store and had a lot of customers, and my father was a lawyer and had a lot of clients. None of those customers or clients would come to see me as their doctor with their illnesses today if I were a provider. The use of the terminology of “providers” and “customers” lowers all health care staff to the lowest common denominator and demeans the concerns of my patients.
I do not mean to diminish the role of the auto mechanic and salesperson, but they know and I know that our roles and are different and we are not just providers of a medical commodity. They do not expect me to deal with them as though they were coming to buy a car. They understand that we are actually trying to cure and treat worried patients and not to sell to customers in a show room.
This change in nomenclature that has permeated health care has had significant effects on how medical care is provided. Hospital care has been depersonalized in order to expedite hospital stays and maximize reimbursement. Gone is the hospital visit of your doctors when you need them the most.
Part of it is the complexity of contemporary care that requires the input from varying levels of expertise. Patients are often shuttled from one doctor to another. Communication is carried out through the web and rarely doctor to doctor. Often doctors are dealt with both at the patient level and the administrative level as commodities off the shelf, like buying a pair of shoes. And doctors in the hospital and in the clinic can be replaced by another one as the shift changes or the schedule dictates with little regard to the patient’s – or customer’s – choice.
Can we return to the days of yore? Probably not. All we can do now is try to inject some level of humanity and empathy as we see our patients in today’s world of mechanized medicine.
Dr. Goldstein, medical editor of Cardiology News, is a professor of medicine at Wayne State University and the division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.
Fake medical news: The black salve and the black arts
Jake clearly needed a biopsy.
When I suggested that we find out what that new growth on his cheek was, he responded with fear. “Do you really need to test it?” he asked. Then he proposed an alternative.
“I had another spot last year,” he said. “This European doctor I saw in somebody’s home put a special black salve on it, and it went away.”
“Who was this doctor?” I asked.
“At the time, I was a raw vegan,” he said. “One of our group members gave me the doctor’s name. He has a big reputation in Europe. He treated people locally in people’s living rooms.”
“Do you recall his name?” I asked him.
Jake didn’t. But I did.
Three years ago, a frightened, middle-aged woman named Josie came to see me with ugly scarring all over her face.
Josie’s story was similar to Jake’s: A famous European doctor. Somebody’s living room.
“He had me lie on the floor,” she recalled, “and he put on some kind of salve. It burned horribly. I was screaming in pain. He washed it off, but it still burned for a long time. This is what it left,” she said, pointing to denting and discoloration on her cheeks and upper lip. She remembered the man’s name.
It took just a few clicks to find him. He wasn’t a licensed doctor and had fled his home country ahead of fraud charges for illegal and harmful practice.
I couldn’t offer Josie much, beyond advising her to avoid getting treated on living room floors by strange practitioners with painful salves.
If you don’t know about the treatment Josie and Jake underwent – it’s called “escharotic treatment” – you can look it up on Wikipedia. It’s also the topic of a case study in the May issue of JAMA Dermatology (2018;154[5]:618-9).
Escharotic treatment has been around a long time. It is used for cancers of the skin and cervix, among others. The principle behind The idea behind both is to apply something that blisters the skin and raises a scab. The eschar is supposed to draw the evil out of the body and bring cure.
Smile if you want, but this idea has been around forever and will likely outlast many treatments we now use. Fake news is old news, and does not need social media to spread (though Facebook helps).
Apparently ordinary people believe strange, irrational, harmful things. Why? Why on earth would Jake and Josie let somebody they don’t know put black goop that hurts like hell on their faces as they lie on a stranger’s carpet? Some thoughts:
- Fear. They think they have cancer and are afraid to find out.
- Suspicion. They don’t trust doctors.
- People they hang with tell them to. Some groups harbor a suspicious, even hostile stance toward conventional medicine, convinced that its principles are unnatural and its practitioners are more concerned with profit and prestige than with the good of their patients.
Those who hold such beliefs, like various conspiracy theorists, span the political and social spectrum, from left to right, and they’ve been around forever.
I don’t plan to try convincing them otherwise. No one can convince them. Citing facts and authority gets you nowhere. As Jonathan Swift said, “You cannot reason someone out of something they did not reason themselves into.”
Fake political news is a problem for society. Fake medical news can be a problem for doctors. A pediatrician confronting an antivaxer family must decide whether to try negotiating (giving their kid vaccines a little at a time) or to give up and send them elsewhere.
It takes effort for physicians to have patience with people who let unscrupulous strangers etch and mutilate their faces. As professionals, however, we doctors are obligated to care even for people we don’t like or agree with. We should therefore try to understand why people who undertake dangerous and irrational treatments think the way they do.
Often, what such patients mainly are is afraid. Still, the ones who actually show up in our offices are willing to at least consider medical opinion. Those who aren’t would never show up.
Jake had enough faith in me to let me calm him down enough to do the biopsy.
It was benign.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
Jake clearly needed a biopsy.
When I suggested that we find out what that new growth on his cheek was, he responded with fear. “Do you really need to test it?” he asked. Then he proposed an alternative.
“I had another spot last year,” he said. “This European doctor I saw in somebody’s home put a special black salve on it, and it went away.”
“Who was this doctor?” I asked.
“At the time, I was a raw vegan,” he said. “One of our group members gave me the doctor’s name. He has a big reputation in Europe. He treated people locally in people’s living rooms.”
“Do you recall his name?” I asked him.
Jake didn’t. But I did.
Three years ago, a frightened, middle-aged woman named Josie came to see me with ugly scarring all over her face.
Josie’s story was similar to Jake’s: A famous European doctor. Somebody’s living room.
“He had me lie on the floor,” she recalled, “and he put on some kind of salve. It burned horribly. I was screaming in pain. He washed it off, but it still burned for a long time. This is what it left,” she said, pointing to denting and discoloration on her cheeks and upper lip. She remembered the man’s name.
It took just a few clicks to find him. He wasn’t a licensed doctor and had fled his home country ahead of fraud charges for illegal and harmful practice.
I couldn’t offer Josie much, beyond advising her to avoid getting treated on living room floors by strange practitioners with painful salves.
If you don’t know about the treatment Josie and Jake underwent – it’s called “escharotic treatment” – you can look it up on Wikipedia. It’s also the topic of a case study in the May issue of JAMA Dermatology (2018;154[5]:618-9).
Escharotic treatment has been around a long time. It is used for cancers of the skin and cervix, among others. The principle behind The idea behind both is to apply something that blisters the skin and raises a scab. The eschar is supposed to draw the evil out of the body and bring cure.
Smile if you want, but this idea has been around forever and will likely outlast many treatments we now use. Fake news is old news, and does not need social media to spread (though Facebook helps).
Apparently ordinary people believe strange, irrational, harmful things. Why? Why on earth would Jake and Josie let somebody they don’t know put black goop that hurts like hell on their faces as they lie on a stranger’s carpet? Some thoughts:
- Fear. They think they have cancer and are afraid to find out.
- Suspicion. They don’t trust doctors.
- People they hang with tell them to. Some groups harbor a suspicious, even hostile stance toward conventional medicine, convinced that its principles are unnatural and its practitioners are more concerned with profit and prestige than with the good of their patients.
Those who hold such beliefs, like various conspiracy theorists, span the political and social spectrum, from left to right, and they’ve been around forever.
I don’t plan to try convincing them otherwise. No one can convince them. Citing facts and authority gets you nowhere. As Jonathan Swift said, “You cannot reason someone out of something they did not reason themselves into.”
Fake political news is a problem for society. Fake medical news can be a problem for doctors. A pediatrician confronting an antivaxer family must decide whether to try negotiating (giving their kid vaccines a little at a time) or to give up and send them elsewhere.
It takes effort for physicians to have patience with people who let unscrupulous strangers etch and mutilate their faces. As professionals, however, we doctors are obligated to care even for people we don’t like or agree with. We should therefore try to understand why people who undertake dangerous and irrational treatments think the way they do.
Often, what such patients mainly are is afraid. Still, the ones who actually show up in our offices are willing to at least consider medical opinion. Those who aren’t would never show up.
Jake had enough faith in me to let me calm him down enough to do the biopsy.
It was benign.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
Jake clearly needed a biopsy.
When I suggested that we find out what that new growth on his cheek was, he responded with fear. “Do you really need to test it?” he asked. Then he proposed an alternative.
“I had another spot last year,” he said. “This European doctor I saw in somebody’s home put a special black salve on it, and it went away.”
“Who was this doctor?” I asked.
“At the time, I was a raw vegan,” he said. “One of our group members gave me the doctor’s name. He has a big reputation in Europe. He treated people locally in people’s living rooms.”
“Do you recall his name?” I asked him.
Jake didn’t. But I did.
Three years ago, a frightened, middle-aged woman named Josie came to see me with ugly scarring all over her face.
Josie’s story was similar to Jake’s: A famous European doctor. Somebody’s living room.
“He had me lie on the floor,” she recalled, “and he put on some kind of salve. It burned horribly. I was screaming in pain. He washed it off, but it still burned for a long time. This is what it left,” she said, pointing to denting and discoloration on her cheeks and upper lip. She remembered the man’s name.
It took just a few clicks to find him. He wasn’t a licensed doctor and had fled his home country ahead of fraud charges for illegal and harmful practice.
I couldn’t offer Josie much, beyond advising her to avoid getting treated on living room floors by strange practitioners with painful salves.
If you don’t know about the treatment Josie and Jake underwent – it’s called “escharotic treatment” – you can look it up on Wikipedia. It’s also the topic of a case study in the May issue of JAMA Dermatology (2018;154[5]:618-9).
Escharotic treatment has been around a long time. It is used for cancers of the skin and cervix, among others. The principle behind The idea behind both is to apply something that blisters the skin and raises a scab. The eschar is supposed to draw the evil out of the body and bring cure.
Smile if you want, but this idea has been around forever and will likely outlast many treatments we now use. Fake news is old news, and does not need social media to spread (though Facebook helps).
Apparently ordinary people believe strange, irrational, harmful things. Why? Why on earth would Jake and Josie let somebody they don’t know put black goop that hurts like hell on their faces as they lie on a stranger’s carpet? Some thoughts:
- Fear. They think they have cancer and are afraid to find out.
- Suspicion. They don’t trust doctors.
- People they hang with tell them to. Some groups harbor a suspicious, even hostile stance toward conventional medicine, convinced that its principles are unnatural and its practitioners are more concerned with profit and prestige than with the good of their patients.
Those who hold such beliefs, like various conspiracy theorists, span the political and social spectrum, from left to right, and they’ve been around forever.
I don’t plan to try convincing them otherwise. No one can convince them. Citing facts and authority gets you nowhere. As Jonathan Swift said, “You cannot reason someone out of something they did not reason themselves into.”
Fake political news is a problem for society. Fake medical news can be a problem for doctors. A pediatrician confronting an antivaxer family must decide whether to try negotiating (giving their kid vaccines a little at a time) or to give up and send them elsewhere.
It takes effort for physicians to have patience with people who let unscrupulous strangers etch and mutilate their faces. As professionals, however, we doctors are obligated to care even for people we don’t like or agree with. We should therefore try to understand why people who undertake dangerous and irrational treatments think the way they do.
Often, what such patients mainly are is afraid. Still, the ones who actually show up in our offices are willing to at least consider medical opinion. Those who aren’t would never show up.
Jake had enough faith in me to let me calm him down enough to do the biopsy.
It was benign.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
The diagnosis and treatment of ureteral injury
A gynecologic surgeon learns very early in his/her career to respect the ureter. Whether from the procedure being performed (endometriosis surgery, hysterectomy, myomectomy for ligamentous fibroids, salpingo-oophorectomy, excision of ovarian remnants, adhesiolysis), blood loss that obscures visualization and must be controlled, or use of energy for cutting, desiccation, and coagulation leading to potential lateral tissue damage, ureteral injury is a well-known complication. Even normal anatomic variations may put some women at greater risk; according to Hurd et al. (Am J Obstet Gynecol. 2001;184:336-9). In a small subset of women, the distance between the cervix and the ureter may be less than 0.5 cm.
As a practicing minimally invasive gynecologic surgeon for the past 30 years, and an early adapter to laparoscopic hysterectomy, I remember quite well the recommendation to always dissect out ureters at time of the procedure. At present, most will agree that selective dissection is safe and thus, more desirable, as bleeding, damage secondary to desiccation, and ureter devascularization with subsequent necrosis are all increased with ureterolysis.
I agree with Dr. Kenton and Dr. Mueller that ureteral stenting has not been shown to significantly decrease ureteral injury rates. Often times, with loss of peristalsis secondary to stent placement, locating the ureter may be even more difficult. Recent advances using lighted stents or indocyanine green, which fluoresces in response to near-infrared laser and can be injected into the ureter via the ureteral catheter tip, are still in the feasibility phase of evaluation and can be costly.
As most urogenital fistulae are secondary to unrecognized injuries at time of surgery, and due to the fact that intraoperative recognition of the injury allows for primary repair, thus, decreasing the rate of secondary surgery and the associated increased morbidity, I recommend cystoscopy to check for ureteral jets (ureteral efflux) be performed when there is concern regarding ureter compromise.
Currently, I utilize a 70° cystoscope to visualize the ureters. While in the past, I have used intravenous indigo carmine, methylene blue, or fluorescein sodium, I currently use Pyridium (phenazopyridine) 200 mg taken by mouth 1 hour prior to the procedure.
Unfortunately, ureteral jetting still may be noted despite partial ligation, laceration, or desiccation of the ureter.
If ureteral injury is not recognized at time of surgery, it can lead to various postoperative symptoms. If there is a ureteral defect, the patient may note profuse wound leakage, increased abdominal fluid, or a urinoma, ileus, fever, peritonitis, or hematuria. With ureteral obstruction, flank or abdominal pain or anuria can be noted; while, with fistula formation, the patient will likely present with urinary incontinence or watery vaginal discharge.
Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL.
A gynecologic surgeon learns very early in his/her career to respect the ureter. Whether from the procedure being performed (endometriosis surgery, hysterectomy, myomectomy for ligamentous fibroids, salpingo-oophorectomy, excision of ovarian remnants, adhesiolysis), blood loss that obscures visualization and must be controlled, or use of energy for cutting, desiccation, and coagulation leading to potential lateral tissue damage, ureteral injury is a well-known complication. Even normal anatomic variations may put some women at greater risk; according to Hurd et al. (Am J Obstet Gynecol. 2001;184:336-9). In a small subset of women, the distance between the cervix and the ureter may be less than 0.5 cm.
As a practicing minimally invasive gynecologic surgeon for the past 30 years, and an early adapter to laparoscopic hysterectomy, I remember quite well the recommendation to always dissect out ureters at time of the procedure. At present, most will agree that selective dissection is safe and thus, more desirable, as bleeding, damage secondary to desiccation, and ureter devascularization with subsequent necrosis are all increased with ureterolysis.
I agree with Dr. Kenton and Dr. Mueller that ureteral stenting has not been shown to significantly decrease ureteral injury rates. Often times, with loss of peristalsis secondary to stent placement, locating the ureter may be even more difficult. Recent advances using lighted stents or indocyanine green, which fluoresces in response to near-infrared laser and can be injected into the ureter via the ureteral catheter tip, are still in the feasibility phase of evaluation and can be costly.
As most urogenital fistulae are secondary to unrecognized injuries at time of surgery, and due to the fact that intraoperative recognition of the injury allows for primary repair, thus, decreasing the rate of secondary surgery and the associated increased morbidity, I recommend cystoscopy to check for ureteral jets (ureteral efflux) be performed when there is concern regarding ureter compromise.
Currently, I utilize a 70° cystoscope to visualize the ureters. While in the past, I have used intravenous indigo carmine, methylene blue, or fluorescein sodium, I currently use Pyridium (phenazopyridine) 200 mg taken by mouth 1 hour prior to the procedure.
Unfortunately, ureteral jetting still may be noted despite partial ligation, laceration, or desiccation of the ureter.
If ureteral injury is not recognized at time of surgery, it can lead to various postoperative symptoms. If there is a ureteral defect, the patient may note profuse wound leakage, increased abdominal fluid, or a urinoma, ileus, fever, peritonitis, or hematuria. With ureteral obstruction, flank or abdominal pain or anuria can be noted; while, with fistula formation, the patient will likely present with urinary incontinence or watery vaginal discharge.
Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL.
A gynecologic surgeon learns very early in his/her career to respect the ureter. Whether from the procedure being performed (endometriosis surgery, hysterectomy, myomectomy for ligamentous fibroids, salpingo-oophorectomy, excision of ovarian remnants, adhesiolysis), blood loss that obscures visualization and must be controlled, or use of energy for cutting, desiccation, and coagulation leading to potential lateral tissue damage, ureteral injury is a well-known complication. Even normal anatomic variations may put some women at greater risk; according to Hurd et al. (Am J Obstet Gynecol. 2001;184:336-9). In a small subset of women, the distance between the cervix and the ureter may be less than 0.5 cm.
As a practicing minimally invasive gynecologic surgeon for the past 30 years, and an early adapter to laparoscopic hysterectomy, I remember quite well the recommendation to always dissect out ureters at time of the procedure. At present, most will agree that selective dissection is safe and thus, more desirable, as bleeding, damage secondary to desiccation, and ureter devascularization with subsequent necrosis are all increased with ureterolysis.
I agree with Dr. Kenton and Dr. Mueller that ureteral stenting has not been shown to significantly decrease ureteral injury rates. Often times, with loss of peristalsis secondary to stent placement, locating the ureter may be even more difficult. Recent advances using lighted stents or indocyanine green, which fluoresces in response to near-infrared laser and can be injected into the ureter via the ureteral catheter tip, are still in the feasibility phase of evaluation and can be costly.
As most urogenital fistulae are secondary to unrecognized injuries at time of surgery, and due to the fact that intraoperative recognition of the injury allows for primary repair, thus, decreasing the rate of secondary surgery and the associated increased morbidity, I recommend cystoscopy to check for ureteral jets (ureteral efflux) be performed when there is concern regarding ureter compromise.
Currently, I utilize a 70° cystoscope to visualize the ureters. While in the past, I have used intravenous indigo carmine, methylene blue, or fluorescein sodium, I currently use Pyridium (phenazopyridine) 200 mg taken by mouth 1 hour prior to the procedure.
Unfortunately, ureteral jetting still may be noted despite partial ligation, laceration, or desiccation of the ureter.
If ureteral injury is not recognized at time of surgery, it can lead to various postoperative symptoms. If there is a ureteral defect, the patient may note profuse wound leakage, increased abdominal fluid, or a urinoma, ileus, fever, peritonitis, or hematuria. With ureteral obstruction, flank or abdominal pain or anuria can be noted; while, with fistula formation, the patient will likely present with urinary incontinence or watery vaginal discharge.
Dr. Miller is a minimally invasive gynecologic surgeon in Naperville, Ill., and a past president of the AAGL.
USPSTF: Fall prevention in the elderly? Think exercise
The United States Preventive Services Task Force (USPSTF) commissioned a systematic evidence review of 62 randomized clinical trials with a total of 35,058 patients to gather evidence on the effectiveness and harms of primary care–relevant interventions to prevent falls in community-dwelling adults 65 years or older.1 It thereby has updated its 2012 statement, in which exercise or physical therapy and vitamin D supplementation were recommended to prevent falls.
Importance
Scope of review
Out of the 62 randomized clinical trials, 65% of intervention studies targeted patients at high risk of falls; they were most commonly identified by history of prior falls, but mobility, gait, and balance impairment were often also considered. Specific medical diagnoses that could affect fall-related outcomes (osteoporosis, visual impairment, neurocognitive disorders) were excluded. This review did not look at the outcome of studies in populations who were vitamin D deficient because, in this population, vitamin D supplementation would be considered treatment rather than prevention. Of note, women constituted the majority in most studies.
Exercise interventions
USPSTF found five good-quality and 16 fair-quality studies, which altogether included a total of 7,297 patients, that reported on various exercise interventions to prevent falls; altogether, these studies included a total of 7,297 patients. Of the studies, 57% recruited populations at high risk for falls with a mean age ranging from 68 to 88 years. Exercise interventions included supervised individual classes, group classes, and physical therapy. The most common exercise component was gait, balance, and functional training; other common components included, in order of frequency, were resistance training, flexibility training, and endurance training. Most common frequency and duration were three sessions per week for 12 months. Exercise interventions reduced the number of persons experiencing a fall (relative risk 0.89; 95% confidence interval, 0.81-0.97), reduced the number of injurious falls (incidence rate ratio, 0.81; 95% CI, 0.73-0.90), and revealed a statistically insignificant reduction in the number of falls. Reported adverse events were minor and most commonly included pain or bruising related to exercise.
Multifactorial interventions
USPSTF found seven good-quality and 19 fair-quality studies that reported on multifactorial interventions; altogether, these studies included a total of 15,506 patients. Of the studies, 73% recruited populations at high risk for falls, and the mean age ranged from 71.9 to 85 years. Multifactorial interventions had two components:
- Initial assessment to screen for modifiable risk factors for falls (multidisciplinary comprehensive geriatric assessment or specific assessment that evaluated various factors, such as balance, gait, vision, cardiovascular health, medication, environment, cognition, and psychological health).
- Subsequent customized interventions (group or individual exercise, cognitive-behavioral therapy, nutrition, environmental modification, physical or occupational therapy, social or community services, and referral to specialists).
While studies found that multifactorial interventions reduced the number of falls (IRR, 0.79; 95% CI, 0.68-0.91), they did not reduce the number of people who experienced a fall (RR, 0.95; 95% CI, 0.89-1.01) or an injurious fall (RR, 0.94; 95% CI, 0.85-1.03). Four studies reported minor harm, mostly bruising, from exercise. Therefore, USPSTF has recommended that clinicians take into consideration patient’s medical history (including prior falls and comorbidities) to selectively offer multifactorial interventions.
Vitamin D supplementation
USPSTF found four good-quality and three fair-quality studies that reported on the effect of vitamin D supplementation on the prevention of falls; altogether, these studies included a total of 7,531 patients. Of the studies, 43% recruited populations at high risk for falls. The mean age ranged from 71 to 76.8 years, and mean serum 25-OH vitamin D levels ranged from 26.4 to 31.8 ng/mL. Vitamin D formulations and dosages varied among trials from 700 IU/day to 150,000 IU/3 months to 500,000 IU/year. Pooled analyses did not show a significant reduction in falls (IRR, 0.97; 95% CI, 0.79-1.20) or the number of persons experiencing a fall (RR, 0.97; 95% CI, 0.88-1.08). Only two trials reported on injurious falls; one reported an increase and the other reported no statistically significant difference. One study using high doses of Vitamin D supplementation (500,000 IU per year) showed statistically significant increase in all three endpoints.
Recommendation of others for fall prevention
The National Institution of Aging has emphasized exercise for strength and balance, monitoring for environmental hazards, and hearing and vision care, as well as medication management. The American Geriatric Society (AGS) has recommended asking about prior falls annually and assessing gait and balance on those who have experienced a fall. The AGS also has recommended strength and gait training, environmental modification, medication management, and vitamin D supplementation of at least 800 IU/day for those vitamin D deficient or at increased risk of falls. The Center for Disease Control and Prevention recommends STEADI (Stopping Elderly Accidents, Deaths & Injuries), a coordinated approach to implement the AGS’s clinical practice guidelines. The American Academy of Family Physicians recommends exercise or physical therapy and vitamin D supplementation.
The bottom line
Regarding reduction of falls, the USPSTF found adequate evidence that exercise interventions confer a moderate net benefit, multifactorial interventions have a small net benefit, and vitamin D supplementation offers no net benefit in preventing falls.
References
1. Guirquis-Blake JM et al. JAMA. 2018 Apr 24;319(16):1705-16.
2. U.S. Preventive Services Task Force et al. JAMA. 2018 Apr 24;319(16):1696-1704.
Dr. Shrestha is a first-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
.
The United States Preventive Services Task Force (USPSTF) commissioned a systematic evidence review of 62 randomized clinical trials with a total of 35,058 patients to gather evidence on the effectiveness and harms of primary care–relevant interventions to prevent falls in community-dwelling adults 65 years or older.1 It thereby has updated its 2012 statement, in which exercise or physical therapy and vitamin D supplementation were recommended to prevent falls.
Importance
Scope of review
Out of the 62 randomized clinical trials, 65% of intervention studies targeted patients at high risk of falls; they were most commonly identified by history of prior falls, but mobility, gait, and balance impairment were often also considered. Specific medical diagnoses that could affect fall-related outcomes (osteoporosis, visual impairment, neurocognitive disorders) were excluded. This review did not look at the outcome of studies in populations who were vitamin D deficient because, in this population, vitamin D supplementation would be considered treatment rather than prevention. Of note, women constituted the majority in most studies.
Exercise interventions
USPSTF found five good-quality and 16 fair-quality studies, which altogether included a total of 7,297 patients, that reported on various exercise interventions to prevent falls; altogether, these studies included a total of 7,297 patients. Of the studies, 57% recruited populations at high risk for falls with a mean age ranging from 68 to 88 years. Exercise interventions included supervised individual classes, group classes, and physical therapy. The most common exercise component was gait, balance, and functional training; other common components included, in order of frequency, were resistance training, flexibility training, and endurance training. Most common frequency and duration were three sessions per week for 12 months. Exercise interventions reduced the number of persons experiencing a fall (relative risk 0.89; 95% confidence interval, 0.81-0.97), reduced the number of injurious falls (incidence rate ratio, 0.81; 95% CI, 0.73-0.90), and revealed a statistically insignificant reduction in the number of falls. Reported adverse events were minor and most commonly included pain or bruising related to exercise.
Multifactorial interventions
USPSTF found seven good-quality and 19 fair-quality studies that reported on multifactorial interventions; altogether, these studies included a total of 15,506 patients. Of the studies, 73% recruited populations at high risk for falls, and the mean age ranged from 71.9 to 85 years. Multifactorial interventions had two components:
- Initial assessment to screen for modifiable risk factors for falls (multidisciplinary comprehensive geriatric assessment or specific assessment that evaluated various factors, such as balance, gait, vision, cardiovascular health, medication, environment, cognition, and psychological health).
- Subsequent customized interventions (group or individual exercise, cognitive-behavioral therapy, nutrition, environmental modification, physical or occupational therapy, social or community services, and referral to specialists).
While studies found that multifactorial interventions reduced the number of falls (IRR, 0.79; 95% CI, 0.68-0.91), they did not reduce the number of people who experienced a fall (RR, 0.95; 95% CI, 0.89-1.01) or an injurious fall (RR, 0.94; 95% CI, 0.85-1.03). Four studies reported minor harm, mostly bruising, from exercise. Therefore, USPSTF has recommended that clinicians take into consideration patient’s medical history (including prior falls and comorbidities) to selectively offer multifactorial interventions.
Vitamin D supplementation
USPSTF found four good-quality and three fair-quality studies that reported on the effect of vitamin D supplementation on the prevention of falls; altogether, these studies included a total of 7,531 patients. Of the studies, 43% recruited populations at high risk for falls. The mean age ranged from 71 to 76.8 years, and mean serum 25-OH vitamin D levels ranged from 26.4 to 31.8 ng/mL. Vitamin D formulations and dosages varied among trials from 700 IU/day to 150,000 IU/3 months to 500,000 IU/year. Pooled analyses did not show a significant reduction in falls (IRR, 0.97; 95% CI, 0.79-1.20) or the number of persons experiencing a fall (RR, 0.97; 95% CI, 0.88-1.08). Only two trials reported on injurious falls; one reported an increase and the other reported no statistically significant difference. One study using high doses of Vitamin D supplementation (500,000 IU per year) showed statistically significant increase in all three endpoints.
Recommendation of others for fall prevention
The National Institution of Aging has emphasized exercise for strength and balance, monitoring for environmental hazards, and hearing and vision care, as well as medication management. The American Geriatric Society (AGS) has recommended asking about prior falls annually and assessing gait and balance on those who have experienced a fall. The AGS also has recommended strength and gait training, environmental modification, medication management, and vitamin D supplementation of at least 800 IU/day for those vitamin D deficient or at increased risk of falls. The Center for Disease Control and Prevention recommends STEADI (Stopping Elderly Accidents, Deaths & Injuries), a coordinated approach to implement the AGS’s clinical practice guidelines. The American Academy of Family Physicians recommends exercise or physical therapy and vitamin D supplementation.
The bottom line
Regarding reduction of falls, the USPSTF found adequate evidence that exercise interventions confer a moderate net benefit, multifactorial interventions have a small net benefit, and vitamin D supplementation offers no net benefit in preventing falls.
References
1. Guirquis-Blake JM et al. JAMA. 2018 Apr 24;319(16):1705-16.
2. U.S. Preventive Services Task Force et al. JAMA. 2018 Apr 24;319(16):1696-1704.
Dr. Shrestha is a first-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
.
The United States Preventive Services Task Force (USPSTF) commissioned a systematic evidence review of 62 randomized clinical trials with a total of 35,058 patients to gather evidence on the effectiveness and harms of primary care–relevant interventions to prevent falls in community-dwelling adults 65 years or older.1 It thereby has updated its 2012 statement, in which exercise or physical therapy and vitamin D supplementation were recommended to prevent falls.
Importance
Scope of review
Out of the 62 randomized clinical trials, 65% of intervention studies targeted patients at high risk of falls; they were most commonly identified by history of prior falls, but mobility, gait, and balance impairment were often also considered. Specific medical diagnoses that could affect fall-related outcomes (osteoporosis, visual impairment, neurocognitive disorders) were excluded. This review did not look at the outcome of studies in populations who were vitamin D deficient because, in this population, vitamin D supplementation would be considered treatment rather than prevention. Of note, women constituted the majority in most studies.
Exercise interventions
USPSTF found five good-quality and 16 fair-quality studies, which altogether included a total of 7,297 patients, that reported on various exercise interventions to prevent falls; altogether, these studies included a total of 7,297 patients. Of the studies, 57% recruited populations at high risk for falls with a mean age ranging from 68 to 88 years. Exercise interventions included supervised individual classes, group classes, and physical therapy. The most common exercise component was gait, balance, and functional training; other common components included, in order of frequency, were resistance training, flexibility training, and endurance training. Most common frequency and duration were three sessions per week for 12 months. Exercise interventions reduced the number of persons experiencing a fall (relative risk 0.89; 95% confidence interval, 0.81-0.97), reduced the number of injurious falls (incidence rate ratio, 0.81; 95% CI, 0.73-0.90), and revealed a statistically insignificant reduction in the number of falls. Reported adverse events were minor and most commonly included pain or bruising related to exercise.
Multifactorial interventions
USPSTF found seven good-quality and 19 fair-quality studies that reported on multifactorial interventions; altogether, these studies included a total of 15,506 patients. Of the studies, 73% recruited populations at high risk for falls, and the mean age ranged from 71.9 to 85 years. Multifactorial interventions had two components:
- Initial assessment to screen for modifiable risk factors for falls (multidisciplinary comprehensive geriatric assessment or specific assessment that evaluated various factors, such as balance, gait, vision, cardiovascular health, medication, environment, cognition, and psychological health).
- Subsequent customized interventions (group or individual exercise, cognitive-behavioral therapy, nutrition, environmental modification, physical or occupational therapy, social or community services, and referral to specialists).
While studies found that multifactorial interventions reduced the number of falls (IRR, 0.79; 95% CI, 0.68-0.91), they did not reduce the number of people who experienced a fall (RR, 0.95; 95% CI, 0.89-1.01) or an injurious fall (RR, 0.94; 95% CI, 0.85-1.03). Four studies reported minor harm, mostly bruising, from exercise. Therefore, USPSTF has recommended that clinicians take into consideration patient’s medical history (including prior falls and comorbidities) to selectively offer multifactorial interventions.
Vitamin D supplementation
USPSTF found four good-quality and three fair-quality studies that reported on the effect of vitamin D supplementation on the prevention of falls; altogether, these studies included a total of 7,531 patients. Of the studies, 43% recruited populations at high risk for falls. The mean age ranged from 71 to 76.8 years, and mean serum 25-OH vitamin D levels ranged from 26.4 to 31.8 ng/mL. Vitamin D formulations and dosages varied among trials from 700 IU/day to 150,000 IU/3 months to 500,000 IU/year. Pooled analyses did not show a significant reduction in falls (IRR, 0.97; 95% CI, 0.79-1.20) or the number of persons experiencing a fall (RR, 0.97; 95% CI, 0.88-1.08). Only two trials reported on injurious falls; one reported an increase and the other reported no statistically significant difference. One study using high doses of Vitamin D supplementation (500,000 IU per year) showed statistically significant increase in all three endpoints.
Recommendation of others for fall prevention
The National Institution of Aging has emphasized exercise for strength and balance, monitoring for environmental hazards, and hearing and vision care, as well as medication management. The American Geriatric Society (AGS) has recommended asking about prior falls annually and assessing gait and balance on those who have experienced a fall. The AGS also has recommended strength and gait training, environmental modification, medication management, and vitamin D supplementation of at least 800 IU/day for those vitamin D deficient or at increased risk of falls. The Center for Disease Control and Prevention recommends STEADI (Stopping Elderly Accidents, Deaths & Injuries), a coordinated approach to implement the AGS’s clinical practice guidelines. The American Academy of Family Physicians recommends exercise or physical therapy and vitamin D supplementation.
The bottom line
Regarding reduction of falls, the USPSTF found adequate evidence that exercise interventions confer a moderate net benefit, multifactorial interventions have a small net benefit, and vitamin D supplementation offers no net benefit in preventing falls.
References
1. Guirquis-Blake JM et al. JAMA. 2018 Apr 24;319(16):1705-16.
2. U.S. Preventive Services Task Force et al. JAMA. 2018 Apr 24;319(16):1696-1704.
Dr. Shrestha is a first-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
.
Doctors’ pay involves a lot of unseen work
“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.
Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.
The whole thing takes me about 2 hours every 3 months. I suppose I could hire an accountant or office manager to deal with that stuff, but in solo practice, you do everything you can to keep the overhead low. So I do it myself.
Eight hours a year doesn’t sound too bad, but it got me thinking about all the other ways that work creeps into my home time.
I’m usually at the office around 5:00 a.m., when I start with reviewing charts, doing paperwork, and catching up on dictations until patients start at 8:00 a.m. From then on, they’re a steady stream until 4:00 p.m., when we close up and head home.
I get home and then have 1-2 hours of time paying bills, sorting mail, and catching up on phone calls and other unresolved issues.
On weekends, there’s always other stuff. Payroll for the coming weeks, office bills, and credit card statements I didn’t get to during the week, CME, forms, licensing paperwork, etc.
I’d guess about 15 hours/week goes into nonpatient-related stuff. Each year that’s more than 700 hours (or a little over a month) of extra time. Tack that on to the roughly 60 hours that I spend seeing patients between the office and hospital.
People say we make “a lot” (whatever that is), but they don’t see everything behind it. The 7-12 years of post-college training. The student loans of $200,000 and dating back to when I was 26 years old. The rising costs of overhead and dropping rates of reimbursement. The denied payments in disputes over claims. And, as mentioned above, the huge amount of time this job takes for stuff beyond just seeing patients.
We don’t get paid by the hour, but if we did, the rate would probably be a lot lower than what most would expect.
I suppose I could become employed, and let someone else worry about those things. But the financial impact doesn’t go away. Someone else still has to be doing those things, and since doctors are the ones who generate income in the majority of medical practices, the salaries for everyone else come out of ours. Plus, as I’ve previously written about, I’ve been employed before and got sick of the meetings and memos about cost-sharing, productivity numbers, and dollars earned per square foot.
But whenever I hear the refrain about our field being overpaid, I think about the actual hours the public doesn’t see (or care about). This isn’t a job for slackers, and
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.
Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.
The whole thing takes me about 2 hours every 3 months. I suppose I could hire an accountant or office manager to deal with that stuff, but in solo practice, you do everything you can to keep the overhead low. So I do it myself.
Eight hours a year doesn’t sound too bad, but it got me thinking about all the other ways that work creeps into my home time.
I’m usually at the office around 5:00 a.m., when I start with reviewing charts, doing paperwork, and catching up on dictations until patients start at 8:00 a.m. From then on, they’re a steady stream until 4:00 p.m., when we close up and head home.
I get home and then have 1-2 hours of time paying bills, sorting mail, and catching up on phone calls and other unresolved issues.
On weekends, there’s always other stuff. Payroll for the coming weeks, office bills, and credit card statements I didn’t get to during the week, CME, forms, licensing paperwork, etc.
I’d guess about 15 hours/week goes into nonpatient-related stuff. Each year that’s more than 700 hours (or a little over a month) of extra time. Tack that on to the roughly 60 hours that I spend seeing patients between the office and hospital.
People say we make “a lot” (whatever that is), but they don’t see everything behind it. The 7-12 years of post-college training. The student loans of $200,000 and dating back to when I was 26 years old. The rising costs of overhead and dropping rates of reimbursement. The denied payments in disputes over claims. And, as mentioned above, the huge amount of time this job takes for stuff beyond just seeing patients.
We don’t get paid by the hour, but if we did, the rate would probably be a lot lower than what most would expect.
I suppose I could become employed, and let someone else worry about those things. But the financial impact doesn’t go away. Someone else still has to be doing those things, and since doctors are the ones who generate income in the majority of medical practices, the salaries for everyone else come out of ours. Plus, as I’ve previously written about, I’ve been employed before and got sick of the meetings and memos about cost-sharing, productivity numbers, and dollars earned per square foot.
But whenever I hear the refrain about our field being overpaid, I think about the actual hours the public doesn’t see (or care about). This isn’t a job for slackers, and
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
“Doctors make a lot of money.” We hear that a lot, always from people who aren’t part of the profession.
Last month, I had to do my tax forms. Not my annual forms, but the quarterly withholding ones for the IRS, and for the state, along with the Arizona Department of Economic Security forms.
The whole thing takes me about 2 hours every 3 months. I suppose I could hire an accountant or office manager to deal with that stuff, but in solo practice, you do everything you can to keep the overhead low. So I do it myself.
Eight hours a year doesn’t sound too bad, but it got me thinking about all the other ways that work creeps into my home time.
I’m usually at the office around 5:00 a.m., when I start with reviewing charts, doing paperwork, and catching up on dictations until patients start at 8:00 a.m. From then on, they’re a steady stream until 4:00 p.m., when we close up and head home.
I get home and then have 1-2 hours of time paying bills, sorting mail, and catching up on phone calls and other unresolved issues.
On weekends, there’s always other stuff. Payroll for the coming weeks, office bills, and credit card statements I didn’t get to during the week, CME, forms, licensing paperwork, etc.
I’d guess about 15 hours/week goes into nonpatient-related stuff. Each year that’s more than 700 hours (or a little over a month) of extra time. Tack that on to the roughly 60 hours that I spend seeing patients between the office and hospital.
People say we make “a lot” (whatever that is), but they don’t see everything behind it. The 7-12 years of post-college training. The student loans of $200,000 and dating back to when I was 26 years old. The rising costs of overhead and dropping rates of reimbursement. The denied payments in disputes over claims. And, as mentioned above, the huge amount of time this job takes for stuff beyond just seeing patients.
We don’t get paid by the hour, but if we did, the rate would probably be a lot lower than what most would expect.
I suppose I could become employed, and let someone else worry about those things. But the financial impact doesn’t go away. Someone else still has to be doing those things, and since doctors are the ones who generate income in the majority of medical practices, the salaries for everyone else come out of ours. Plus, as I’ve previously written about, I’ve been employed before and got sick of the meetings and memos about cost-sharing, productivity numbers, and dollars earned per square foot.
But whenever I hear the refrain about our field being overpaid, I think about the actual hours the public doesn’t see (or care about). This isn’t a job for slackers, and
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
The FDA’s novel drugs approved in 2017
Novel drugs are innovative new products that have never before been used in clinical practice. Among the 46 that the Food and Drug Administration approved in 2017, 45 could be used in pregnancy. One, cerliponase alfa (Brineura), is indicated for pediatric patients 3 years of age or older, for treatment of late infantile neuronal ceroid lipofuscinosis type 2. It is doubtful that this drug would be used in pregnancy or during breastfeeding.
With the two exceptions noted below, there are no human pregnancy data for these drugs. It is important to consider that although high molecular weight (MW) drugs (for example, greater than 1,000) probably do not usually cross the placenta in the first half of pregnancy, they may do so in late pregnancy. The cited MWs are shown as the nearest whole number. Animal reproductive data are also cited because, although not definitive, they can provide some measure of the human embryo-fetal risk.
Anti-infectives
Benznidazole (same trade name) (MW 441), given orally, is indicated for pediatric patients aged 2-12 years for treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. However, there are international reports describing its use in pregnancy and breastfeeding. No fetal harm from these exposures were noted. Nevertheless, because of the low MW and the reported animal risk, avoiding the drug during the first half of pregnancy appears to be the best choice. Delafloxacin (Baxdela) (MW 441), a fluoroquinolone antimicrobial given intravenously or orally, is indicated for acute bacterial skin infections. The animal data suggest low risk. However, like other fluoroquinolones, it is contraindicated in pregnancy and should be used only if there are no other alternatives.
Sofosbuvir/velpatasvir /voxilaprevir (Vosevi) (MWs 529, 883, 869), a fixed oral dose combination of three antivirals, is indicated for the treatment of hepatitis C virus infection. The MWs suggest that all three will cross the human placenta. The animal data suggest low risk. Secnidazole (Solosec) (MW 185), given orally, is indicated for the treatment of bacterial vaginosis. It is closely related to metronidazole. No evidence of embryo-fetal toxicity was observed in rats and rabbits, suggesting that the human risk is low. In a report from Brazil, 134 pregnant women with bacterial vaginosis were treated with secnidazole, metronidazole, or tinidazole in the second and third trimesters. Treatment significantly decreased the incidence of premature rupture of membranes, preterm labor, preterm birth, and low birth weight. No fetal harm was reported.
Antineoplastics
[Note: All of the drugs in this category are best avoided, if possible, in pregnancy and breastfeeding.]
Abemaciclib (Verzenio) (MW 507), an oral inhibitor of cyclin-dependent kinases, is indicated for the treatment of breast cancer. The drug is teratogenic in rats. Acalabrutinib (Calquence) (MW 466) is an oral kinase inhibitor indicated for mantle cell lymphoma. The drug had no effect on the rat embryo-fetus but caused decreased fetal body weights and delayed skeletal ossification in rabbits. Avelumab (Bavencio) (MW 147,000) is given intravenously for the treatment of metastatic Merkel cell carcinoma and metastatic urothelial carcinoma. Animal reproduction studies have not been conducted. However, based on its mechanism of action, fetal exposure may increase the risk of developing immune-related disorders or altering the normal immune response.
Brigatinib (Alunbrig) (MW 584) is given orally for the treatment of metastatic non–small-cell lung cancer. In rats, doses less than or slightly above the human exposure caused multiple anomalies in the fetuses of pregnant rats. Copanlisib (Aliqopa) (MW 553) is a kinase inhibitor that is given intravenously for relapsed follicular lymphoma. In rats during organogenesis, doses based on body surface area that were a fraction of the human dose caused embryo-fetal death and fetal defects. Durvalumab (Imfinzi) (MW 146,000), given intravenously, is indicated for the treatment of metastatic urothelial carcinoma and non–small-cell lung cancer. Monkeys given the drug from organogenesis through delivery experienced increased premature birth, fetal loss, and premature neonatal death. Women of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose.
Enasidenib (Idhifa) (MW 569), given orally, is indicated for the treatment of myeloid leukemia. The drug caused maternal toxicity and adverse embryo-fetal effects (postimplantation loss, resorptions, decrease viable fetuses, lower fetal birth weights, and skeletal variations) in rats and spontaneous abortions in rabbits. Inotuzumab ozogamicin (Besponsa) (MW 160,000), given intravenously, is indicated for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The drug caused fetal harm in rats but not in rabbits. Midostaurin (Rydapt) (MW 571) is an oral kinase inhibitor indicated for myeloid leukemia. In rats, a dose given during the first week of pregnancy that was a small fraction of the human exposure caused pre- and postimplantation loss. When very small doses were given during organogenesis to rats and rabbits there was significant maternal and fetal toxicity.
Neratinib (Nerlynx) (MW 673) is an oral kinase inhibitor for breast cancer. Although the drug did not cause embryo-fetal toxicity in rats, it did cause this toxicity in rabbits. Doses that resulted in exposures that were less than the human exposure caused maternal toxicity, abortions, and embryo-fetal death. Lower doses caused multiple fetal anomalies. Niraparib (Zejula) (MW 511) is indicated for treatment of epithelial ovarian, fallopian, or peritoneal cancer. Because of the potential human embryo-fetal risk based on its mechanism of action, pregnant animal studies were not conducted. Women with reproductive potential should use effective contraception during treatment and for 6 months after the last dose. Ribociclib (Kisqali) (MW 553) is an oral kinase inhibitor indicated for postmenopausal women with breast cancer. In rats, the drug cause reduced fetal weights and skeletal changes. Increased incidences of fetal abnormalities and lower fetal weights were observed in rabbits.
Cardiovascular
Angiotensin II (Giapreza) (MW 1,046) is a naturally occurring peptide hormone given as an intravenous infusion. It is indicated as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. Animal reproduction studies have not been conducted. Because septic or other distributive shock is a medical emergency that can be fatal, the use of this agent in pregnancy should not be withheld.
Central nervous system
Deutetrabenazine (Austedo) (MW 324) is an oral drug indicated for the treatment of chorea associated with Huntington’s disease and for tardive dyskinesia. When given to rats during organogenesis there was no clear effect on embryo-fetal development.
Edaravone (Radicava) (MW 174), given as an intravenous infusion, is indicated for the treatment of amyotrophic lateral sclerosis. Doses that were not maternal toxic did not cause embryo-fetal toxicity in rats and rabbits. However, the no-effect dose for developmental toxicity was less than the recommended human dose. Naldemedine (Symproic) (MW 743) is an opioid antagonist indicated for the treatment of opioid-induced constipation. The drug crosses the human placenta and may precipitate opioid withdrawal in the fetus. The drug caused no embryo-fetal adverse effects, even at high doses, in pregnant rats and rabbits.
Ocrelizumab (Ocrevus) (MW 145,000), an intravenous agent, is used to treat patients with multiple sclerosis. The MW is high but immunoglobulins are known to cross the placenta. When given to monkeys at doses similar to or greater than the human dose, there was increased perinatal mortality, depletion of B-cell populations, and renal, bone marrow, and testicular toxicity in the offspring in the absence of maternal toxicity. Safinamide (Xadago) (MW 399) is an oral drug indicated as adjunctive treatment to levodopa/carbidopa in Parkinson’s disease. In rats, the drug was teratogenic (mainly urogenital defects) at all doses. When it was combined with levodopa/carbidopa or used alone, increased rates of fetal visceral and skeletal defects occurred at all doses studied. In rabbits, given the combination throughout organogenesis, there was an increased incidence of embryo-fetal death and cardiac and skeletal defects. Based on these data, avoiding the drug in pregnancy appears to be the best course.
Valbenazine (Ingrezza) (MW 419) is indicated for the treatment of tardive dyskinesia. The drug caused no malformations in rats and rabbits. However, in rats given the drug during organogenesis through lactation, an increase in the number of stillborn pups and postnatal pup mortalities was observed.
Dermatologic
Brodalumab (Siliq) (MW 144,000), given subcutaneously, is indicated for the treatment of moderate to severe plaque psoriasis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In monkeys, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from mothers given weekly subcutaneous doses of the drug. Dupilumab (Dupixent) (MW 144,000) is given subcutaneously for the treatment of atopic dermatitis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In pregnant monkeys given subcutaneous doses of the drug, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from birth to 6 months of age.
Guselkumab (Tremfya) (MW 143,600) is given subcutaneously for the treatment of moderate to severe plaque psoriasis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In pregnant monkeys given subcutaneous doses of the drug, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from birth to 6 months of age. However, neonatal deaths were observed in three monkeys given six times the maximum recommended human dose.
Endocrine/metabolic
Deflazacort (Emflaza) (MW 442) is an oral corticosteroid prodrug indicated for the treatment of Duchenne muscular dystrophy. The drug is converted in vivo to an active metabolite. The drug readily crosses the placenta. Although animal reproduction studies have not been conducted, such studies with other corticosteroids in various animal species have shown an increased incidence of cleft palate. In some species, there was an increase in embryo-fetal death, intrauterine growth restriction, and constriction of the ductus arteriosus.
Ertugliflozin (Steglatro) (MW 566) is an oral drug indicated to improve glycemic control in adults with type 2 diabetes mellitus. In juvenile rats, doses that were about 13 times the human dose caused increased kidney weight, renal tubule and renal pelvis dilatation, and renal mineralization. These effects occurred during periods of rat renal development that correspond to the late second and third trimester of human renal development, and did not fully reverse within a 1-month recovery period. Etelcalcetide (Parsabiv) (MW 1,048), an intravenous calcium-sensing receptor agonist, is indicated for patients on hemodialysis who have secondary hyperparathyroidism. In rats and rabbits given the drug during organogenesis, there was reduced fetal growth. In rats given the drug during organogenesis through birth and weaning, there was a slight increase in pup mortality, delay in parturition, and transient effects on pup growth, but there were no effects on sexual maturation, neurobehavioral, or reproductive function. Macimorelin (Macrilen) (MW 535) is an oral growth hormone secretagogue receptor agonist. It is indicated for adult growth hormone deficiency. Animal reproduction studies have not been conducted.
Semaglutide (Ozempic) (MW 4,114), given subcutaneously, is a glucagon-like peptide indicated to improve glycemic control in type 2 diabetes mellitus. In rats given the drug during organogenesis, embryo-fetal death, structural defects, and alterations in growth were observed. In rabbits and monkeys given the drug during organogenesis, there were early pregnancy losses and structural abnormalities. In addition, there was marked maternal body weight loss in both animal species. Vestronidase alfa-vjbk (Mepsevii) is given intravenously. It is indicated for the treatment of Mucopolysaccharidosis VII (Sly syndrome). The calculated average MW of each nonglycosylated peptide chain is 72,562. In rats and rabbits given the drug during organogenesis, there was no maternal toxicity or adverse developmental outcomes.
Gastrointestinal
Plecanatide (Trulance) (MW 1,682) is an oral drug indicated for the treatment of constipation. The drug and its active metabolite are negligibly absorbed systemically and fetal exposure to the drug is not expected. In mice and rabbits given the oral drug during organogenesis, no effects on embryo-fetal development were observed. Telotristat ethyl (Xermelo) (MW 754) is an oral drug indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (MW not specified) therapy in adults not controlled by somatostatin analog. When given during organogenesis in rats, there was no effect on embryo-fetal development at doses that were about nine times the recommended human dose. However, an increased incidence of mortality in rat offspring was observed when the drug was given from organogenesis through lactation. During organogenesis in rabbits, the drug had no embryo-fetal effects at doses that were 10 or more times the human dose.
Hematologics
Betrixaban (Bevyxxa) (MW 568) is an oral factor Xa inhibitor indicated for the prophylaxis of venous thromboembolism. The drug was not associated with adverse developmental fetal outcomes in rats and rabbits. However, maternal hemorrhage did occur. In humans, there is an increased risk of hemorrhage during pregnancy and delivery. Emicizumab (Hemlibra) (MW 145,600), given subcutaneously, is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding in patients with hemophilia A with factor VIII inhibitors. Animal reproduction studies have not been conducted. It is a human monoclonal IgG antibody and, though the MW is high, IgG antibodies are known to cross the placenta.
Immunologic
Sarilumab (Kevzara) (MW 150,000) is given subcutaneously. It is indicated for patients with moderate to severe rheumatoid arthritis. Reproduction studies were conducted in pregnant monkeys. There was no evidence of embryo toxicity or fetal malformations. Based on this data, the human pregnancy risk is low.
Ophthalmic
Latanoprostene bunod (Vyzulta) (MW 508) is a prostaglandin analog that is indicated to reduce intraocular pressure. No quantifiable plasma concentrations of latanoprostene bunod were detected in nonpregnant patients. However, very low levels of latanoprost acid (51-59 pg/mL), the active metabolite, were detected with the maximal plasma concentration occurring 5 minutes after administration. When given intravenously to pregnant rabbits, the drug was shown to be abortifacient and teratogenic, but these effects were not observed in pregnant rats. Netarsudil (Rhopressa) (MW 454) is a kinase inhibitor indicated to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. No quantifiable plasma concentrations of netarsudil were detected in 18 subjects. For the active metabolite, a plasma level of 0.11 ng/mL was found in one subject. Intravenous doses to pregnant rats and rabbits during organogenesis did not cause embryo-fetal adverse effects at clinically relevant systemic exposures.
Parathyroid hormone
Abaloparatide (Tymlos) (MW 3,961), given subcutaneously, is a human parathyroid hormone related peptide analog that is indicated for postmenopausal women with osteoporosis at high risk for fracture. Reproduction studies in animals have not been conducted. Because of the indication, it is doubtful if the agent will be used in pregnancy or during breastfeeding.
Respiratory
Benralizumab (Fasenra) (MW 150,000), given subcutaneously, is indicated for the add-on maintenance treatment of severe eosinophilic asthma. It is a human monoclonal IgG antibody and, though the MW is high, IgG antibodies are known to cross the placenta. Studies in monkeys found no evidence of fetal harm with intravenous doses throughout pregnancy that produced exposures up to about 310 times the exposure at the maximum recommended human dose.
The potential adverse effects in an infant when the mother is taking one of the above drugs while breastfeeding will be covered in my next column.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.
Novel drugs are innovative new products that have never before been used in clinical practice. Among the 46 that the Food and Drug Administration approved in 2017, 45 could be used in pregnancy. One, cerliponase alfa (Brineura), is indicated for pediatric patients 3 years of age or older, for treatment of late infantile neuronal ceroid lipofuscinosis type 2. It is doubtful that this drug would be used in pregnancy or during breastfeeding.
With the two exceptions noted below, there are no human pregnancy data for these drugs. It is important to consider that although high molecular weight (MW) drugs (for example, greater than 1,000) probably do not usually cross the placenta in the first half of pregnancy, they may do so in late pregnancy. The cited MWs are shown as the nearest whole number. Animal reproductive data are also cited because, although not definitive, they can provide some measure of the human embryo-fetal risk.
Anti-infectives
Benznidazole (same trade name) (MW 441), given orally, is indicated for pediatric patients aged 2-12 years for treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. However, there are international reports describing its use in pregnancy and breastfeeding. No fetal harm from these exposures were noted. Nevertheless, because of the low MW and the reported animal risk, avoiding the drug during the first half of pregnancy appears to be the best choice. Delafloxacin (Baxdela) (MW 441), a fluoroquinolone antimicrobial given intravenously or orally, is indicated for acute bacterial skin infections. The animal data suggest low risk. However, like other fluoroquinolones, it is contraindicated in pregnancy and should be used only if there are no other alternatives.
Sofosbuvir/velpatasvir /voxilaprevir (Vosevi) (MWs 529, 883, 869), a fixed oral dose combination of three antivirals, is indicated for the treatment of hepatitis C virus infection. The MWs suggest that all three will cross the human placenta. The animal data suggest low risk. Secnidazole (Solosec) (MW 185), given orally, is indicated for the treatment of bacterial vaginosis. It is closely related to metronidazole. No evidence of embryo-fetal toxicity was observed in rats and rabbits, suggesting that the human risk is low. In a report from Brazil, 134 pregnant women with bacterial vaginosis were treated with secnidazole, metronidazole, or tinidazole in the second and third trimesters. Treatment significantly decreased the incidence of premature rupture of membranes, preterm labor, preterm birth, and low birth weight. No fetal harm was reported.
Antineoplastics
[Note: All of the drugs in this category are best avoided, if possible, in pregnancy and breastfeeding.]
Abemaciclib (Verzenio) (MW 507), an oral inhibitor of cyclin-dependent kinases, is indicated for the treatment of breast cancer. The drug is teratogenic in rats. Acalabrutinib (Calquence) (MW 466) is an oral kinase inhibitor indicated for mantle cell lymphoma. The drug had no effect on the rat embryo-fetus but caused decreased fetal body weights and delayed skeletal ossification in rabbits. Avelumab (Bavencio) (MW 147,000) is given intravenously for the treatment of metastatic Merkel cell carcinoma and metastatic urothelial carcinoma. Animal reproduction studies have not been conducted. However, based on its mechanism of action, fetal exposure may increase the risk of developing immune-related disorders or altering the normal immune response.
Brigatinib (Alunbrig) (MW 584) is given orally for the treatment of metastatic non–small-cell lung cancer. In rats, doses less than or slightly above the human exposure caused multiple anomalies in the fetuses of pregnant rats. Copanlisib (Aliqopa) (MW 553) is a kinase inhibitor that is given intravenously for relapsed follicular lymphoma. In rats during organogenesis, doses based on body surface area that were a fraction of the human dose caused embryo-fetal death and fetal defects. Durvalumab (Imfinzi) (MW 146,000), given intravenously, is indicated for the treatment of metastatic urothelial carcinoma and non–small-cell lung cancer. Monkeys given the drug from organogenesis through delivery experienced increased premature birth, fetal loss, and premature neonatal death. Women of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose.
Enasidenib (Idhifa) (MW 569), given orally, is indicated for the treatment of myeloid leukemia. The drug caused maternal toxicity and adverse embryo-fetal effects (postimplantation loss, resorptions, decrease viable fetuses, lower fetal birth weights, and skeletal variations) in rats and spontaneous abortions in rabbits. Inotuzumab ozogamicin (Besponsa) (MW 160,000), given intravenously, is indicated for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The drug caused fetal harm in rats but not in rabbits. Midostaurin (Rydapt) (MW 571) is an oral kinase inhibitor indicated for myeloid leukemia. In rats, a dose given during the first week of pregnancy that was a small fraction of the human exposure caused pre- and postimplantation loss. When very small doses were given during organogenesis to rats and rabbits there was significant maternal and fetal toxicity.
Neratinib (Nerlynx) (MW 673) is an oral kinase inhibitor for breast cancer. Although the drug did not cause embryo-fetal toxicity in rats, it did cause this toxicity in rabbits. Doses that resulted in exposures that were less than the human exposure caused maternal toxicity, abortions, and embryo-fetal death. Lower doses caused multiple fetal anomalies. Niraparib (Zejula) (MW 511) is indicated for treatment of epithelial ovarian, fallopian, or peritoneal cancer. Because of the potential human embryo-fetal risk based on its mechanism of action, pregnant animal studies were not conducted. Women with reproductive potential should use effective contraception during treatment and for 6 months after the last dose. Ribociclib (Kisqali) (MW 553) is an oral kinase inhibitor indicated for postmenopausal women with breast cancer. In rats, the drug cause reduced fetal weights and skeletal changes. Increased incidences of fetal abnormalities and lower fetal weights were observed in rabbits.
Cardiovascular
Angiotensin II (Giapreza) (MW 1,046) is a naturally occurring peptide hormone given as an intravenous infusion. It is indicated as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. Animal reproduction studies have not been conducted. Because septic or other distributive shock is a medical emergency that can be fatal, the use of this agent in pregnancy should not be withheld.
Central nervous system
Deutetrabenazine (Austedo) (MW 324) is an oral drug indicated for the treatment of chorea associated with Huntington’s disease and for tardive dyskinesia. When given to rats during organogenesis there was no clear effect on embryo-fetal development.
Edaravone (Radicava) (MW 174), given as an intravenous infusion, is indicated for the treatment of amyotrophic lateral sclerosis. Doses that were not maternal toxic did not cause embryo-fetal toxicity in rats and rabbits. However, the no-effect dose for developmental toxicity was less than the recommended human dose. Naldemedine (Symproic) (MW 743) is an opioid antagonist indicated for the treatment of opioid-induced constipation. The drug crosses the human placenta and may precipitate opioid withdrawal in the fetus. The drug caused no embryo-fetal adverse effects, even at high doses, in pregnant rats and rabbits.
Ocrelizumab (Ocrevus) (MW 145,000), an intravenous agent, is used to treat patients with multiple sclerosis. The MW is high but immunoglobulins are known to cross the placenta. When given to monkeys at doses similar to or greater than the human dose, there was increased perinatal mortality, depletion of B-cell populations, and renal, bone marrow, and testicular toxicity in the offspring in the absence of maternal toxicity. Safinamide (Xadago) (MW 399) is an oral drug indicated as adjunctive treatment to levodopa/carbidopa in Parkinson’s disease. In rats, the drug was teratogenic (mainly urogenital defects) at all doses. When it was combined with levodopa/carbidopa or used alone, increased rates of fetal visceral and skeletal defects occurred at all doses studied. In rabbits, given the combination throughout organogenesis, there was an increased incidence of embryo-fetal death and cardiac and skeletal defects. Based on these data, avoiding the drug in pregnancy appears to be the best course.
Valbenazine (Ingrezza) (MW 419) is indicated for the treatment of tardive dyskinesia. The drug caused no malformations in rats and rabbits. However, in rats given the drug during organogenesis through lactation, an increase in the number of stillborn pups and postnatal pup mortalities was observed.
Dermatologic
Brodalumab (Siliq) (MW 144,000), given subcutaneously, is indicated for the treatment of moderate to severe plaque psoriasis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In monkeys, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from mothers given weekly subcutaneous doses of the drug. Dupilumab (Dupixent) (MW 144,000) is given subcutaneously for the treatment of atopic dermatitis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In pregnant monkeys given subcutaneous doses of the drug, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from birth to 6 months of age.
Guselkumab (Tremfya) (MW 143,600) is given subcutaneously for the treatment of moderate to severe plaque psoriasis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In pregnant monkeys given subcutaneous doses of the drug, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from birth to 6 months of age. However, neonatal deaths were observed in three monkeys given six times the maximum recommended human dose.
Endocrine/metabolic
Deflazacort (Emflaza) (MW 442) is an oral corticosteroid prodrug indicated for the treatment of Duchenne muscular dystrophy. The drug is converted in vivo to an active metabolite. The drug readily crosses the placenta. Although animal reproduction studies have not been conducted, such studies with other corticosteroids in various animal species have shown an increased incidence of cleft palate. In some species, there was an increase in embryo-fetal death, intrauterine growth restriction, and constriction of the ductus arteriosus.
Ertugliflozin (Steglatro) (MW 566) is an oral drug indicated to improve glycemic control in adults with type 2 diabetes mellitus. In juvenile rats, doses that were about 13 times the human dose caused increased kidney weight, renal tubule and renal pelvis dilatation, and renal mineralization. These effects occurred during periods of rat renal development that correspond to the late second and third trimester of human renal development, and did not fully reverse within a 1-month recovery period. Etelcalcetide (Parsabiv) (MW 1,048), an intravenous calcium-sensing receptor agonist, is indicated for patients on hemodialysis who have secondary hyperparathyroidism. In rats and rabbits given the drug during organogenesis, there was reduced fetal growth. In rats given the drug during organogenesis through birth and weaning, there was a slight increase in pup mortality, delay in parturition, and transient effects on pup growth, but there were no effects on sexual maturation, neurobehavioral, or reproductive function. Macimorelin (Macrilen) (MW 535) is an oral growth hormone secretagogue receptor agonist. It is indicated for adult growth hormone deficiency. Animal reproduction studies have not been conducted.
Semaglutide (Ozempic) (MW 4,114), given subcutaneously, is a glucagon-like peptide indicated to improve glycemic control in type 2 diabetes mellitus. In rats given the drug during organogenesis, embryo-fetal death, structural defects, and alterations in growth were observed. In rabbits and monkeys given the drug during organogenesis, there were early pregnancy losses and structural abnormalities. In addition, there was marked maternal body weight loss in both animal species. Vestronidase alfa-vjbk (Mepsevii) is given intravenously. It is indicated for the treatment of Mucopolysaccharidosis VII (Sly syndrome). The calculated average MW of each nonglycosylated peptide chain is 72,562. In rats and rabbits given the drug during organogenesis, there was no maternal toxicity or adverse developmental outcomes.
Gastrointestinal
Plecanatide (Trulance) (MW 1,682) is an oral drug indicated for the treatment of constipation. The drug and its active metabolite are negligibly absorbed systemically and fetal exposure to the drug is not expected. In mice and rabbits given the oral drug during organogenesis, no effects on embryo-fetal development were observed. Telotristat ethyl (Xermelo) (MW 754) is an oral drug indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (MW not specified) therapy in adults not controlled by somatostatin analog. When given during organogenesis in rats, there was no effect on embryo-fetal development at doses that were about nine times the recommended human dose. However, an increased incidence of mortality in rat offspring was observed when the drug was given from organogenesis through lactation. During organogenesis in rabbits, the drug had no embryo-fetal effects at doses that were 10 or more times the human dose.
Hematologics
Betrixaban (Bevyxxa) (MW 568) is an oral factor Xa inhibitor indicated for the prophylaxis of venous thromboembolism. The drug was not associated with adverse developmental fetal outcomes in rats and rabbits. However, maternal hemorrhage did occur. In humans, there is an increased risk of hemorrhage during pregnancy and delivery. Emicizumab (Hemlibra) (MW 145,600), given subcutaneously, is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding in patients with hemophilia A with factor VIII inhibitors. Animal reproduction studies have not been conducted. It is a human monoclonal IgG antibody and, though the MW is high, IgG antibodies are known to cross the placenta.
Immunologic
Sarilumab (Kevzara) (MW 150,000) is given subcutaneously. It is indicated for patients with moderate to severe rheumatoid arthritis. Reproduction studies were conducted in pregnant monkeys. There was no evidence of embryo toxicity or fetal malformations. Based on this data, the human pregnancy risk is low.
Ophthalmic
Latanoprostene bunod (Vyzulta) (MW 508) is a prostaglandin analog that is indicated to reduce intraocular pressure. No quantifiable plasma concentrations of latanoprostene bunod were detected in nonpregnant patients. However, very low levels of latanoprost acid (51-59 pg/mL), the active metabolite, were detected with the maximal plasma concentration occurring 5 minutes after administration. When given intravenously to pregnant rabbits, the drug was shown to be abortifacient and teratogenic, but these effects were not observed in pregnant rats. Netarsudil (Rhopressa) (MW 454) is a kinase inhibitor indicated to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. No quantifiable plasma concentrations of netarsudil were detected in 18 subjects. For the active metabolite, a plasma level of 0.11 ng/mL was found in one subject. Intravenous doses to pregnant rats and rabbits during organogenesis did not cause embryo-fetal adverse effects at clinically relevant systemic exposures.
Parathyroid hormone
Abaloparatide (Tymlos) (MW 3,961), given subcutaneously, is a human parathyroid hormone related peptide analog that is indicated for postmenopausal women with osteoporosis at high risk for fracture. Reproduction studies in animals have not been conducted. Because of the indication, it is doubtful if the agent will be used in pregnancy or during breastfeeding.
Respiratory
Benralizumab (Fasenra) (MW 150,000), given subcutaneously, is indicated for the add-on maintenance treatment of severe eosinophilic asthma. It is a human monoclonal IgG antibody and, though the MW is high, IgG antibodies are known to cross the placenta. Studies in monkeys found no evidence of fetal harm with intravenous doses throughout pregnancy that produced exposures up to about 310 times the exposure at the maximum recommended human dose.
The potential adverse effects in an infant when the mother is taking one of the above drugs while breastfeeding will be covered in my next column.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.
Novel drugs are innovative new products that have never before been used in clinical practice. Among the 46 that the Food and Drug Administration approved in 2017, 45 could be used in pregnancy. One, cerliponase alfa (Brineura), is indicated for pediatric patients 3 years of age or older, for treatment of late infantile neuronal ceroid lipofuscinosis type 2. It is doubtful that this drug would be used in pregnancy or during breastfeeding.
With the two exceptions noted below, there are no human pregnancy data for these drugs. It is important to consider that although high molecular weight (MW) drugs (for example, greater than 1,000) probably do not usually cross the placenta in the first half of pregnancy, they may do so in late pregnancy. The cited MWs are shown as the nearest whole number. Animal reproductive data are also cited because, although not definitive, they can provide some measure of the human embryo-fetal risk.
Anti-infectives
Benznidazole (same trade name) (MW 441), given orally, is indicated for pediatric patients aged 2-12 years for treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. However, there are international reports describing its use in pregnancy and breastfeeding. No fetal harm from these exposures were noted. Nevertheless, because of the low MW and the reported animal risk, avoiding the drug during the first half of pregnancy appears to be the best choice. Delafloxacin (Baxdela) (MW 441), a fluoroquinolone antimicrobial given intravenously or orally, is indicated for acute bacterial skin infections. The animal data suggest low risk. However, like other fluoroquinolones, it is contraindicated in pregnancy and should be used only if there are no other alternatives.
Sofosbuvir/velpatasvir /voxilaprevir (Vosevi) (MWs 529, 883, 869), a fixed oral dose combination of three antivirals, is indicated for the treatment of hepatitis C virus infection. The MWs suggest that all three will cross the human placenta. The animal data suggest low risk. Secnidazole (Solosec) (MW 185), given orally, is indicated for the treatment of bacterial vaginosis. It is closely related to metronidazole. No evidence of embryo-fetal toxicity was observed in rats and rabbits, suggesting that the human risk is low. In a report from Brazil, 134 pregnant women with bacterial vaginosis were treated with secnidazole, metronidazole, or tinidazole in the second and third trimesters. Treatment significantly decreased the incidence of premature rupture of membranes, preterm labor, preterm birth, and low birth weight. No fetal harm was reported.
Antineoplastics
[Note: All of the drugs in this category are best avoided, if possible, in pregnancy and breastfeeding.]
Abemaciclib (Verzenio) (MW 507), an oral inhibitor of cyclin-dependent kinases, is indicated for the treatment of breast cancer. The drug is teratogenic in rats. Acalabrutinib (Calquence) (MW 466) is an oral kinase inhibitor indicated for mantle cell lymphoma. The drug had no effect on the rat embryo-fetus but caused decreased fetal body weights and delayed skeletal ossification in rabbits. Avelumab (Bavencio) (MW 147,000) is given intravenously for the treatment of metastatic Merkel cell carcinoma and metastatic urothelial carcinoma. Animal reproduction studies have not been conducted. However, based on its mechanism of action, fetal exposure may increase the risk of developing immune-related disorders or altering the normal immune response.
Brigatinib (Alunbrig) (MW 584) is given orally for the treatment of metastatic non–small-cell lung cancer. In rats, doses less than or slightly above the human exposure caused multiple anomalies in the fetuses of pregnant rats. Copanlisib (Aliqopa) (MW 553) is a kinase inhibitor that is given intravenously for relapsed follicular lymphoma. In rats during organogenesis, doses based on body surface area that were a fraction of the human dose caused embryo-fetal death and fetal defects. Durvalumab (Imfinzi) (MW 146,000), given intravenously, is indicated for the treatment of metastatic urothelial carcinoma and non–small-cell lung cancer. Monkeys given the drug from organogenesis through delivery experienced increased premature birth, fetal loss, and premature neonatal death. Women of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose.
Enasidenib (Idhifa) (MW 569), given orally, is indicated for the treatment of myeloid leukemia. The drug caused maternal toxicity and adverse embryo-fetal effects (postimplantation loss, resorptions, decrease viable fetuses, lower fetal birth weights, and skeletal variations) in rats and spontaneous abortions in rabbits. Inotuzumab ozogamicin (Besponsa) (MW 160,000), given intravenously, is indicated for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The drug caused fetal harm in rats but not in rabbits. Midostaurin (Rydapt) (MW 571) is an oral kinase inhibitor indicated for myeloid leukemia. In rats, a dose given during the first week of pregnancy that was a small fraction of the human exposure caused pre- and postimplantation loss. When very small doses were given during organogenesis to rats and rabbits there was significant maternal and fetal toxicity.
Neratinib (Nerlynx) (MW 673) is an oral kinase inhibitor for breast cancer. Although the drug did not cause embryo-fetal toxicity in rats, it did cause this toxicity in rabbits. Doses that resulted in exposures that were less than the human exposure caused maternal toxicity, abortions, and embryo-fetal death. Lower doses caused multiple fetal anomalies. Niraparib (Zejula) (MW 511) is indicated for treatment of epithelial ovarian, fallopian, or peritoneal cancer. Because of the potential human embryo-fetal risk based on its mechanism of action, pregnant animal studies were not conducted. Women with reproductive potential should use effective contraception during treatment and for 6 months after the last dose. Ribociclib (Kisqali) (MW 553) is an oral kinase inhibitor indicated for postmenopausal women with breast cancer. In rats, the drug cause reduced fetal weights and skeletal changes. Increased incidences of fetal abnormalities and lower fetal weights were observed in rabbits.
Cardiovascular
Angiotensin II (Giapreza) (MW 1,046) is a naturally occurring peptide hormone given as an intravenous infusion. It is indicated as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. Animal reproduction studies have not been conducted. Because septic or other distributive shock is a medical emergency that can be fatal, the use of this agent in pregnancy should not be withheld.
Central nervous system
Deutetrabenazine (Austedo) (MW 324) is an oral drug indicated for the treatment of chorea associated with Huntington’s disease and for tardive dyskinesia. When given to rats during organogenesis there was no clear effect on embryo-fetal development.
Edaravone (Radicava) (MW 174), given as an intravenous infusion, is indicated for the treatment of amyotrophic lateral sclerosis. Doses that were not maternal toxic did not cause embryo-fetal toxicity in rats and rabbits. However, the no-effect dose for developmental toxicity was less than the recommended human dose. Naldemedine (Symproic) (MW 743) is an opioid antagonist indicated for the treatment of opioid-induced constipation. The drug crosses the human placenta and may precipitate opioid withdrawal in the fetus. The drug caused no embryo-fetal adverse effects, even at high doses, in pregnant rats and rabbits.
Ocrelizumab (Ocrevus) (MW 145,000), an intravenous agent, is used to treat patients with multiple sclerosis. The MW is high but immunoglobulins are known to cross the placenta. When given to monkeys at doses similar to or greater than the human dose, there was increased perinatal mortality, depletion of B-cell populations, and renal, bone marrow, and testicular toxicity in the offspring in the absence of maternal toxicity. Safinamide (Xadago) (MW 399) is an oral drug indicated as adjunctive treatment to levodopa/carbidopa in Parkinson’s disease. In rats, the drug was teratogenic (mainly urogenital defects) at all doses. When it was combined with levodopa/carbidopa or used alone, increased rates of fetal visceral and skeletal defects occurred at all doses studied. In rabbits, given the combination throughout organogenesis, there was an increased incidence of embryo-fetal death and cardiac and skeletal defects. Based on these data, avoiding the drug in pregnancy appears to be the best course.
Valbenazine (Ingrezza) (MW 419) is indicated for the treatment of tardive dyskinesia. The drug caused no malformations in rats and rabbits. However, in rats given the drug during organogenesis through lactation, an increase in the number of stillborn pups and postnatal pup mortalities was observed.
Dermatologic
Brodalumab (Siliq) (MW 144,000), given subcutaneously, is indicated for the treatment of moderate to severe plaque psoriasis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In monkeys, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from mothers given weekly subcutaneous doses of the drug. Dupilumab (Dupixent) (MW 144,000) is given subcutaneously for the treatment of atopic dermatitis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In pregnant monkeys given subcutaneous doses of the drug, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from birth to 6 months of age.
Guselkumab (Tremfya) (MW 143,600) is given subcutaneously for the treatment of moderate to severe plaque psoriasis. It is a human monoclonal IgG antibody and, even though the MW is high, IgG antibodies are known to cross the placenta. In pregnant monkeys given subcutaneous doses of the drug, no drug-related effects on embryo-fetal toxicity or malformations, or on morphological, functional, or immunological development were observed in infants from birth to 6 months of age. However, neonatal deaths were observed in three monkeys given six times the maximum recommended human dose.
Endocrine/metabolic
Deflazacort (Emflaza) (MW 442) is an oral corticosteroid prodrug indicated for the treatment of Duchenne muscular dystrophy. The drug is converted in vivo to an active metabolite. The drug readily crosses the placenta. Although animal reproduction studies have not been conducted, such studies with other corticosteroids in various animal species have shown an increased incidence of cleft palate. In some species, there was an increase in embryo-fetal death, intrauterine growth restriction, and constriction of the ductus arteriosus.
Ertugliflozin (Steglatro) (MW 566) is an oral drug indicated to improve glycemic control in adults with type 2 diabetes mellitus. In juvenile rats, doses that were about 13 times the human dose caused increased kidney weight, renal tubule and renal pelvis dilatation, and renal mineralization. These effects occurred during periods of rat renal development that correspond to the late second and third trimester of human renal development, and did not fully reverse within a 1-month recovery period. Etelcalcetide (Parsabiv) (MW 1,048), an intravenous calcium-sensing receptor agonist, is indicated for patients on hemodialysis who have secondary hyperparathyroidism. In rats and rabbits given the drug during organogenesis, there was reduced fetal growth. In rats given the drug during organogenesis through birth and weaning, there was a slight increase in pup mortality, delay in parturition, and transient effects on pup growth, but there were no effects on sexual maturation, neurobehavioral, or reproductive function. Macimorelin (Macrilen) (MW 535) is an oral growth hormone secretagogue receptor agonist. It is indicated for adult growth hormone deficiency. Animal reproduction studies have not been conducted.
Semaglutide (Ozempic) (MW 4,114), given subcutaneously, is a glucagon-like peptide indicated to improve glycemic control in type 2 diabetes mellitus. In rats given the drug during organogenesis, embryo-fetal death, structural defects, and alterations in growth were observed. In rabbits and monkeys given the drug during organogenesis, there were early pregnancy losses and structural abnormalities. In addition, there was marked maternal body weight loss in both animal species. Vestronidase alfa-vjbk (Mepsevii) is given intravenously. It is indicated for the treatment of Mucopolysaccharidosis VII (Sly syndrome). The calculated average MW of each nonglycosylated peptide chain is 72,562. In rats and rabbits given the drug during organogenesis, there was no maternal toxicity or adverse developmental outcomes.
Gastrointestinal
Plecanatide (Trulance) (MW 1,682) is an oral drug indicated for the treatment of constipation. The drug and its active metabolite are negligibly absorbed systemically and fetal exposure to the drug is not expected. In mice and rabbits given the oral drug during organogenesis, no effects on embryo-fetal development were observed. Telotristat ethyl (Xermelo) (MW 754) is an oral drug indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (MW not specified) therapy in adults not controlled by somatostatin analog. When given during organogenesis in rats, there was no effect on embryo-fetal development at doses that were about nine times the recommended human dose. However, an increased incidence of mortality in rat offspring was observed when the drug was given from organogenesis through lactation. During organogenesis in rabbits, the drug had no embryo-fetal effects at doses that were 10 or more times the human dose.
Hematologics
Betrixaban (Bevyxxa) (MW 568) is an oral factor Xa inhibitor indicated for the prophylaxis of venous thromboembolism. The drug was not associated with adverse developmental fetal outcomes in rats and rabbits. However, maternal hemorrhage did occur. In humans, there is an increased risk of hemorrhage during pregnancy and delivery. Emicizumab (Hemlibra) (MW 145,600), given subcutaneously, is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding in patients with hemophilia A with factor VIII inhibitors. Animal reproduction studies have not been conducted. It is a human monoclonal IgG antibody and, though the MW is high, IgG antibodies are known to cross the placenta.
Immunologic
Sarilumab (Kevzara) (MW 150,000) is given subcutaneously. It is indicated for patients with moderate to severe rheumatoid arthritis. Reproduction studies were conducted in pregnant monkeys. There was no evidence of embryo toxicity or fetal malformations. Based on this data, the human pregnancy risk is low.
Ophthalmic
Latanoprostene bunod (Vyzulta) (MW 508) is a prostaglandin analog that is indicated to reduce intraocular pressure. No quantifiable plasma concentrations of latanoprostene bunod were detected in nonpregnant patients. However, very low levels of latanoprost acid (51-59 pg/mL), the active metabolite, were detected with the maximal plasma concentration occurring 5 minutes after administration. When given intravenously to pregnant rabbits, the drug was shown to be abortifacient and teratogenic, but these effects were not observed in pregnant rats. Netarsudil (Rhopressa) (MW 454) is a kinase inhibitor indicated to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension. No quantifiable plasma concentrations of netarsudil were detected in 18 subjects. For the active metabolite, a plasma level of 0.11 ng/mL was found in one subject. Intravenous doses to pregnant rats and rabbits during organogenesis did not cause embryo-fetal adverse effects at clinically relevant systemic exposures.
Parathyroid hormone
Abaloparatide (Tymlos) (MW 3,961), given subcutaneously, is a human parathyroid hormone related peptide analog that is indicated for postmenopausal women with osteoporosis at high risk for fracture. Reproduction studies in animals have not been conducted. Because of the indication, it is doubtful if the agent will be used in pregnancy or during breastfeeding.
Respiratory
Benralizumab (Fasenra) (MW 150,000), given subcutaneously, is indicated for the add-on maintenance treatment of severe eosinophilic asthma. It is a human monoclonal IgG antibody and, though the MW is high, IgG antibodies are known to cross the placenta. Studies in monkeys found no evidence of fetal harm with intravenous doses throughout pregnancy that produced exposures up to about 310 times the exposure at the maximum recommended human dose.
The potential adverse effects in an infant when the mother is taking one of the above drugs while breastfeeding will be covered in my next column.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. He coauthored “Drugs in Pregnancy and Lactation” and coedited “Diseases, Complications, and Drug Therapy in Obstetrics.” He reported having no relevant financial disclosures.
Reflections on providing on-call overnight care for psychiatric patients
A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.
In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.
As part of yearlong monitoring research, I’ve asked my fellow residents at George Washington University, in Washington, to participate in a quality improvement survey. It collects information on the number of patients evaluated overnight while on call and also asks residents to rate their on-call experiences on an “emotional pain scale” with space for a qualitative comment. The emotional pain scale is a simple visual analog scale for pain, with a smiley face representing 0 pain and the sad face with tears representing the 10 out of 10, worst pain imaginable. Initially, the emotional pain scale seemed a lighthearted and somewhat silly way for residents to vent about their on-call experience. A year of data collection later, I consider the emotional pain scale an important acknowledgment to my fellow residents that being on call is physically and emotionally taxing.
At the 2018 American Psychiatric Association meeting in New York, I presented findings from this survey data, examining the quantitative information showing that sheer volume of patients correlates with higher emotional pain scores. But while compiling and analyzing the data for my presentation, I also found myself reading and rereading the comments left by my colleagues about their hardest nights. As I read, I reflected on my own 60 nights on call, and my personal experiences between the highs and lows of emotional pain.
As an homage to the educational and emotional power of being on call, I’d like to share a few vignettes from my years of overnight calls from across the emotional pain scale. (Key demographic details have been omitted to protect patients’ privacy.):
- 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.
- 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
- 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.
Dr. Jacqueline Posada - 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
- 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.
- 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.
Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.
A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.
In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.
As part of yearlong monitoring research, I’ve asked my fellow residents at George Washington University, in Washington, to participate in a quality improvement survey. It collects information on the number of patients evaluated overnight while on call and also asks residents to rate their on-call experiences on an “emotional pain scale” with space for a qualitative comment. The emotional pain scale is a simple visual analog scale for pain, with a smiley face representing 0 pain and the sad face with tears representing the 10 out of 10, worst pain imaginable. Initially, the emotional pain scale seemed a lighthearted and somewhat silly way for residents to vent about their on-call experience. A year of data collection later, I consider the emotional pain scale an important acknowledgment to my fellow residents that being on call is physically and emotionally taxing.
At the 2018 American Psychiatric Association meeting in New York, I presented findings from this survey data, examining the quantitative information showing that sheer volume of patients correlates with higher emotional pain scores. But while compiling and analyzing the data for my presentation, I also found myself reading and rereading the comments left by my colleagues about their hardest nights. As I read, I reflected on my own 60 nights on call, and my personal experiences between the highs and lows of emotional pain.
As an homage to the educational and emotional power of being on call, I’d like to share a few vignettes from my years of overnight calls from across the emotional pain scale. (Key demographic details have been omitted to protect patients’ privacy.):
- 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.
- 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
- 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.
Dr. Jacqueline Posada - 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
- 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.
- 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.
Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.
A transition is coming. My fourth and final year of residency starts soon – meaning that from July 1, 2018, I’ll never again be on call overnight as a psychiatry resident. July 1 marks the end of 2 years as a PGY2 and PGY3, during which I’ve worked 60 overnight shifts.
In our residency program, the on-call shift is a continuation of daytime duties, and the experience is a formative physician-in-training/quasi-hazing process of care provision for 24 hours straight. Previously, I’ve recounted experiences from my overnight on-call shifts and reflected on the intensity of working with emotionally distressed individuals in the emergency department. I never thought I’d say it, but I will miss working in the middle of the night, particularly in the ED. In the small hours of the morning, the strange aura of hospital existence, and desperation of sickness isn’t washed out by daylight and the inhibitions of business hours.
As part of yearlong monitoring research, I’ve asked my fellow residents at George Washington University, in Washington, to participate in a quality improvement survey. It collects information on the number of patients evaluated overnight while on call and also asks residents to rate their on-call experiences on an “emotional pain scale” with space for a qualitative comment. The emotional pain scale is a simple visual analog scale for pain, with a smiley face representing 0 pain and the sad face with tears representing the 10 out of 10, worst pain imaginable. Initially, the emotional pain scale seemed a lighthearted and somewhat silly way for residents to vent about their on-call experience. A year of data collection later, I consider the emotional pain scale an important acknowledgment to my fellow residents that being on call is physically and emotionally taxing.
At the 2018 American Psychiatric Association meeting in New York, I presented findings from this survey data, examining the quantitative information showing that sheer volume of patients correlates with higher emotional pain scores. But while compiling and analyzing the data for my presentation, I also found myself reading and rereading the comments left by my colleagues about their hardest nights. As I read, I reflected on my own 60 nights on call, and my personal experiences between the highs and lows of emotional pain.
As an homage to the educational and emotional power of being on call, I’d like to share a few vignettes from my years of overnight calls from across the emotional pain scale. (Key demographic details have been omitted to protect patients’ privacy.):
- 0: There is no such thing as 0 emotional pain when asked to stay overnight in the hospital.
- 1: This is a full night of sleep on the uncomfortable bunk beds in the GWU call room. On occasion, I’ve had a night with one consult. Only once in 2 years did I have a night in which not a single consult was called from the ED and all the patients on the psychiatric unit slept as soundly as I did.
- 4: There’s a man I’ve seen in the ED seven times over the last 2 years. That’s more than 10% of my nights on call, so we’re well acquainted – though he has trouble remembering me. He’s an alcoholic, though I know the official diagnosis is alcohol use disorder–severe. His addiction is, indeed, severe; I’ve never seen him sober. Every time, he tells me how his wife is cheating on him, and he’s been depressed since his eldest son was killed in a shooting 10 years ago. He sits under a bridge and drinks liquor until he either goes home or to an ED. I feel for him. Several times, other residents and I have transferred him to a local detoxification unit with discharge to a 30-day drug rehab program. It doesn’t stick. The last time I evaluated him, I sent him home to his wife with a cab voucher. My emotional pain is equal parts pity and frustration over my ineffectual impact on his life. He, and others like him, used to cause me more emotional pain. Eventually, the pain is dulled.
Dr. Jacqueline Posada - 5: The mean pain scale score of a GWU resident on call is 5.13. Analysis of the survey data showed the emotional pain score is correlated with the specific resident on call, and my personal average is 5.04. From the way residents talk about being on call, I expected the mean pain scale to be higher. There is no vignette for the mean score; I think of it as all the unremarkable calls blurred together.
- 8: Emotional pain rises with a fraught clinical scenario. One weeknight, I had to involuntarily commit a young lawyer who was psychotic yet adept at hiding it. The lawyer was brought into the ED by police after his brother in Chicago called them to his apartment. The patient had called the brother while standing on his 10th-floor balcony talking nonsensically about conspiracy theories and why he needed to end his life to save the world. In the ED, the patient denied every single part of the story. When I called the brother for collateral, his distress moved me as a both sibling and psychiatrist. The lawyer denied the story up and down, called his brother a liar and the favorite child, and refused to sign into the psychiatric hospital voluntarily. I felt I had no choice but to place him in an involuntary hold. It was a long and busy night, and I tried to put myself in his position and that of his brother who had called the police. Eight is the emotional pain of involuntarily committing someone whose story isn’t black and white. Eight is the pain of exercising authority and beneficence over patient autonomy.
- 10: I was consulted to evaluate a woman for suicidal ideation whose mother had coded and died in the ED an hour before. When the woman was told of her mother’s death, she crumpled to floor, screaming she wanted to die to join her mother. In the tumult, ED staff thought she was running out of the hospital to jump into traffic. She was held in the ED involuntarily until she could be evaluated for safety by psychiatry – me. When I entered her hospital room, she was quietly weeping, whispering: “I want my mom. I want my mom.” I wanted to cry, too. I sat with her in silence for a few minutes and offered my condolences. Yet, as the consultant, I had a job to do: I needed to complete a risk assessment. My voice caught as I explained that I was here to assess her for suicidal thoughts and plans. She looked at me like I was crazy. I felt crazy. I acknowledged the risk of suicide and her expressed desire to join her mother in death. I asked the questions quickly and gently. She shook her head to all my questions and told me she just wanted to go home. I met her daughters in the waiting room who were caught up in grief over the combination of their grandmother’s death and their mother’s reaction. They seemed certain that their mother had not wanted to die, and we agreed it was a situation of the wrong reaction in the wrong place. The daughters agreed to take her home and watch her all night. This is the only 10 I’ve experienced on the emotional pain scale. I felt shame and confusion as I struggled to reconcile my obligation as a psychiatrist, and my true desire to give that woman a hug and send her home without a battery of questions at perhaps her most vulnerable moment.
Dr. Posada is a third-year resident in the psychiatry and behavioral sciences department at George Washington University, Washington. She completed a bachelor’s degree at GWU. For 2 years after her undergraduate education, she worked at the National Institutes of Allergy and Infectious Diseases studying HIV pathogenesis. Dr. Posada completed her medical degree at the University of Texas Medical Branch in Galveston. Her interests include public psychiatry, health care policy, and health disparities, and she plans to pursue a fellowship in consult liaison psychiatry.