Reviews

Barbara S. Levy, MD, spent 29 years in private practice before accepting an appointment as vice president of health policy at the American College of Obstetricians and Gynecologists (ACOG). Those 29 years in private practice weren’t her only window onto the health-care arena, however. She has served as chair of the Resource Based Relative Value Scale Update Committee for the American Medical Association for 3 years; as medical director of Women’s and Children’s Services at Franciscan Health System in Tacoma, Washington; and as a long-time member of the OBG Management Board of Editors. As a result, she offers an informed and well-rounded perspective on the economics of surgical gynecology—the subject of a keynote address she delivered at the 2012 Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in December.

We sat down with Dr. Levy after her talk to explore some of the issues she raised—the focus of this Q&A. Dr. Levy also summarizes the high points of her talk in a video presentation available at obgmanagement.com.

OBG Management: What prompted you to leave private practice, move across country, and accept the post at ACOG?

Dr. Levy: I had spent the better part of 29 years complaining and feeling reasonably unhappy with what organized medicine was doing—or not doing—for ObGyns and our patients. I felt that the specialty was not really out there in front of the curve, driving the bus, so to speak, but was a victim of broader forces. So when I was given an opportunity to influence the way we approach health-care policy, to enable us to drive our own bus, I decided to take the challenge. I’m not sure I can make a difference, but I’m going to do everything possible to put us in control of our destiny. There are a lot of pitfalls out there, but I think that, given a commitment to doing what is right, we may be able to change the way we deliver health care in this country.

OBG Management: So what’s wrong with the way we deliver health care in the United States?

Dr. Levy: We are spending an inordinate amount of money. I’ve heard it referred to as an “investment,” but I’m not sure that word is accurate. It’s really an expenditure of trillions of dollars—as much as 17% of gross domestic product—but what are we getting in return? We’re not getting what we want or need. There is a lot of innovation out there, but what is it bringing us? Do we have better health care in this country, based on our per capita expenditure, than other developed nations have? The answer is “No.”

OBG Management: Why do you think that is?

Dr. Levy: If you look at the growth in Part B Medicare, and focus on where we’re spending the money, the culprits are pharmaceuticals, a huge increase in testing and imaging, and a sharp rise in office-based procedures. The complexity of services has also increased dramatically. Our population is aging, and obesity is epidemic and driving costs for management of diabetes, hypertension, and chronic heart disease, as well as joint replacements and back surgery. About 85% of Medicare dollars go to the care of 15% to 20% of the Medicare population. Yes, we’re reducing death rates from cardiovascular disease and cancer, but now we have a larger population of patients who have chronic, active disease.

OBG Management: Who’s responsible for this problem?

Dr. Levy: Our health-care systems have created this mess in many ways. We spend $98 billion annually on hospitalization for pregnancy and childbirth, but our mortality rate is increasing. We rank 50th in the world in maternal mortality despite a cesarean delivery rate over 30%, despite all the money that we’re spending—with maternal mortality higher here than in almost every European country, as well as several nations in Asia and the Middle East.¹

OBG Management: Why are we spending so much money?

Dr. Levy: We have become so fearful—of poor outcomes, of litigation, and our patients are coming to us with demands for tests and treatment that cost them little or nothing—that we intervene with tests and procedures that increase the cost of care without providing any true benefit in terms of outcome.

We’ve also made some poor choices. We’ve allowed ourselves to be the victims of legislation, of rule-making, because we don’t sit down and read the 1,300 or so pages in the Federal Register from the Centers for Medicare and Medicaid Services (CMS) on proposed rule-making every year. Things happen to us that we aren’t aware of. We have allowed ourselves to be drawn in by innovation, by testing, and by fear until we have begun to do things that may not have any real benefit for our patients.

Both physicians and hospitals have driven volume to increase reimbursement. And industry has been drawn into the mix because the medical field is the only one that’s expanding. We have become our own worst enemies. We have not stepped up to the plate to define quality and value, so now others are doing it—and they don’t necessarily use the same definitions we do. We have allowed our fears of liability and misperceptions about the value of procedures to drive our decisions. For example, when we perform robotic hysterectomy in a woman who is a great candidate for the vaginal approach, we quadruple the cost of the surgery. Consider that we perform roughly 500,000 hysterectomies every year, and you can see how costs mount rapidly.

OBG Management: What are some of the other problems afflicting the US health-care system?

Dr. Levy: There are tremendous disparities in quality and cost across the country. Why? How we spend money in health care is cultural. It’s influenced by what we become accustomed to, what our particular environment calls “standard.” Here’s an example: A man who is experiencing knee pain tries to make an appointment with an orthopedic surgeon, but when he telephones the physician’s office, he is told that he can’t make an appointment until he has an MRI. That’s cultural, not medically justified.

Patients also play a role. When the patient comes in with a ream of paper from the Internet, and she wants a CA 125 test because she thinks it’s somehow going to prevent ovarian cancer, we need to explain to her, in a way she can understand, that adding that testing is of no benefit and may actually cause harm. We need quick statements that can help defuse the demand for increased testing.

Role of the government

OBG Management: What role does the government play?

Dr. Levy: The Medicare Resource-Based Relative Value Scale (RBRVS) was enacted into law in 1992. Most payers now follow this scale to determine reimbursement, based on how many resources it requires to perform a service. Resources are defined in the law—we can’t change them. But the American Medical Association did convene the RBRVS Update Committee (RUC), of which I am the chair, to do the best we can to define for the federal government exactly how many of those resources are necessary for a particular intervention. For example, how much time does it really take to perform laparoscopic supracervical hysterectomy—and how does that compare with reading a computed tomography (CT) scan of the abdomen and pelvis or with performing a five-vessel bypass? How many office visits for hypertension does it take to equal an open-heart surgery and 90 days of care? That’s not an easy set of relative intensities to work through, but the RUC does do that and makes recommendations to CMS for the relative value units (RVUs) for the services we provide.

OBG Management: Is it time alone that determines the value of a service?

Dr. Levy: Physician work is defined as the time it takes to perform a procedure—but also as the intensity of that service as compared with other physician services.

There are also practice-expense RVUs, intended to address the cost of clinical staff, medical supplies, and equipment. Right now approximately 52% of reimbursement goes toward the practice-expense component, and less than 50% for the physician’s work.

In 1992, when the RBRVS was enacted, women’s health services were significantly undervalued because ObGyns did not form a large part of the Medicare fee schedule. Over the past 20 years, ACOG and the RUC have worked diligently to correct those initial inequities.

On the RUC, we believe that no physicians are paid at a level that is fair and appropriate, compared with a plumber or electrician. So the shift to a value-based system and away from the volume-based system may be beneficial to us.

Challenges ahead

OBG Management: What challenges do ObGyns face in attempting to overcome these problems?

Dr. Levy: The primary challenge is to face reality as it is—not as it was in the “good old days” or as we wish it to be. We need to become advocates for ourselves and our patients. Advocacy would support and promote our patients’ health-care rights and enhance community health. It would also foster policy initiatives that focus on availability, safety, and quality of care.

In our advocacy, we need to focus first on quality. If we don’t define quality ourselves, others are going to decide that quality is a constant and that the only thing that matters is cost, and they will shift all services to the lowest-cost providers. That is not the way we want things to go.

Some changes are already in play:

• Out-of-pocket costs for patients are increasing, motivating patients to become more discriminating
• Payment models will soon focus on “episodes of care,” with incentives for systems to reduce surgical volumes while preserving the patient’s quality of life
• Surgery will shift from low-volume surgeons to high-volume physicians who have demonstrated excellent outcomes. This is otherwise known as “value-based purchasing,” based on a model from Harvard Business School.²

Bundled payments will become the norm

OBG Management: Can you elaborate a bit on episodes of care?

Dr. Levy: By episode of care, I mean bundled payments. For example, pregnancy services where prenatal care, delivery, and postpartum care are bundled, or management of fibroids where the diagnosis, imaging, medical, and, potentially, surgical management could all be included in a single payment. All interventions in these periods would be grouped together and reimbursed at a set rate. As a result, the clinicians caring for the patient during these episodes have more of an incentive to reduce unnecessary costs. Are a first-trimester ultrasound scan and two second-trimester scans really necessary? Or might there be a less expensive way to ensure the same optimal outcome? Are the fibroids symptomatic or might observation be a more appropriate option for the patient?

OBG Management: Some people might assume you are prescribing “cookbook medicine” by urging a reduction in variations in care.

Dr. Levy: Not at all. I’m talking about reducing significant variations in outcomes, not processes. Physicians should remain free to treat the patient, using whatever approach they deem to be in her best interest. However, cost pressures mean that we will need to become more creative in keeping costs down without impairing outcomes.

OBG Management: What will happen if physicians don’t keep these cost pressures in mind?

Dr. Levy: People are already keeping score. CMS and payers are using ICD-9 diagnoses, married to the CPT code—the intervention, as well as the episode—and including the costs of things we may have no idea are being spent, such as pharmaceuticals, a return to the emergency room, and so on. We need to be aware of what other people are measuring. We need to understand what we are being measured on: patient satisfaction, quality of life, morbidity and mortality, and cost.

What can gynecologic surgeons do?

OBG Management: Here’s the million dollar question: What can gynecologic surgeons do about this problem?

Dr. Levy: We need to step up to the plate. We need to read the literature critically to focus on clinically meaningful outcomes. Although small differences in blood loss, analgesic use, or operating times may be statistically significant, they do not produce outcomes that are apparent and meaningful to our patients.

We also need to encourage comparative effectiveness research, which is essential to ensure the most clinically meaningful and cost-effective care.

Now that “DSH” payments—disproportional share, or the incremental amount of money that hospitals collected to reimburse them for care of the uninsured—are going away, hospitals are going to need to cut expenses 20% to 25% over the next 3 years to survive. You can bet they are going to change the way they look at you. Be prepared for them to limit the “toys” you are allowed to have, and other cuts.

OBG Management: Can you recommend specific steps?

Dr. Levy: Yes, we need to:

• think creatively to contain costs. A good book on this subject is Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care, by Marty Makary, MD.³
• track our own outcomes. Although it is irritating and time-consuming to enter data, it’s a little easier with electronic medical records. We need to document our own long-term outcomes. In fact, ACOG is working with the American Board of Obstetrics and Gynecology to look at ways we can create a structure for us to track our own outcomes as part of the maintenance of certification (MOC) process. When you track data, the Hawthorne effect comes into play: You get better at the activity you’re tracking, simply by writing it down.
• collaborate with others in our communities to improve public health issues such as obesity, smoking, and teenage access to contraception
• question and challenge preconceived notions and beliefs. We have a lot of them in surgery. For example, we tell patients not to lift after hysterectomy, not to have sex after hysteroscopic resection—but we have absolutely no data suggesting that these admonitions are helpful. Bowel prep is another example. Data have demonstrated that it not only does not benefit the patient, mechanical prep causes harm—but the randomized, controlled trials documenting this fact appear in the surgical literature, not the gynecologic literature. And guess how long it takes for us to incorporate definitive data like that into gynecologic practice? 17 years.
• get a seat at every table to participate in data definitions, acquisition, and dissemination to inform our daily clinical decisions
• participate in efforts to define and improve quality of care.

OBG Management: Any last comments?

Dr. Levy: I just want to emphasize how important it is that we take control of our destiny. If we are not at the table, we may be on the menu! But if we step up to the plate and approach these challenges the right way, we can become the premier surgical specialty.

We want to hear from you!  Tell us what you think.

Barbara S. Levy, MD, spent 29 years in private practice before accepting an appointment as vice president of health policy at the American College of Obstetricians and Gynecologists (ACOG). Those 29 years in private practice weren’t her only window onto the health-care arena, however. She has served as chair of the Resource Based Relative Value Scale Update Committee for the American Medical Association for 3 years; as medical director of Women’s and Children’s Services at Franciscan Health System in Tacoma, Washington; and as a long-time member of the OBG Management Board of Editors. As a result, she offers an informed and well-rounded perspective on the economics of surgical gynecology—the subject of a keynote address she delivered at the 2012 Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in December.

We sat down with Dr. Levy after her talk to explore some of the issues she raised—the focus of this Q&A. Dr. Levy also summarizes the high points of her talk in a video presentation available at obgmanagement.com.

OBG Management: What prompted you to leave private practice, move across country, and accept the post at ACOG?

Dr. Levy: I had spent the better part of 29 years complaining and feeling reasonably unhappy with what organized medicine was doing—or not doing—for ObGyns and our patients. I felt that the specialty was not really out there in front of the curve, driving the bus, so to speak, but was a victim of broader forces. So when I was given an opportunity to influence the way we approach health-care policy, to enable us to drive our own bus, I decided to take the challenge. I’m not sure I can make a difference, but I’m going to do everything possible to put us in control of our destiny. There are a lot of pitfalls out there, but I think that, given a commitment to doing what is right, we may be able to change the way we deliver health care in this country.

OBG Management: So what’s wrong with the way we deliver health care in the United States?

Dr. Levy: We are spending an inordinate amount of money. I’ve heard it referred to as an “investment,” but I’m not sure that word is accurate. It’s really an expenditure of trillions of dollars—as much as 17% of gross domestic product—but what are we getting in return? We’re not getting what we want or need. There is a lot of innovation out there, but what is it bringing us? Do we have better health care in this country, based on our per capita expenditure, than other developed nations have? The answer is “No.”

OBG Management: Why do you think that is?

Dr. Levy: If you look at the growth in Part B Medicare, and focus on where we’re spending the money, the culprits are pharmaceuticals, a huge increase in testing and imaging, and a sharp rise in office-based procedures. The complexity of services has also increased dramatically. Our population is aging, and obesity is epidemic and driving costs for management of diabetes, hypertension, and chronic heart disease, as well as joint replacements and back surgery. About 85% of Medicare dollars go to the care of 15% to 20% of the Medicare population. Yes, we’re reducing death rates from cardiovascular disease and cancer, but now we have a larger population of patients who have chronic, active disease.

OBG Management: Who’s responsible for this problem?

Dr. Levy: Our health-care systems have created this mess in many ways. We spend $98 billion annually on hospitalization for pregnancy and childbirth, but our mortality rate is increasing. We rank 50th in the world in maternal mortality despite a cesarean delivery rate over 30%, despite all the money that we’re spending—with maternal mortality higher here than in almost every European country, as well as several nations in Asia and the Middle East.¹

OBG Management: Why are we spending so much money?

Dr. Levy: We have become so fearful—of poor outcomes, of litigation, and our patients are coming to us with demands for tests and treatment that cost them little or nothing—that we intervene with tests and procedures that increase the cost of care without providing any true benefit in terms of outcome.

We’ve also made some poor choices. We’ve allowed ourselves to be the victims of legislation, of rule-making, because we don’t sit down and read the 1,300 or so pages in the Federal Register from the Centers for Medicare and Medicaid Services (CMS) on proposed rule-making every year. Things happen to us that we aren’t aware of. We have allowed ourselves to be drawn in by innovation, by testing, and by fear until we have begun to do things that may not have any real benefit for our patients.

Both physicians and hospitals have driven volume to increase reimbursement. And industry has been drawn into the mix because the medical field is the only one that’s expanding. We have become our own worst enemies. We have not stepped up to the plate to define quality and value, so now others are doing it—and they don’t necessarily use the same definitions we do. We have allowed our fears of liability and misperceptions about the value of procedures to drive our decisions. For example, when we perform robotic hysterectomy in a woman who is a great candidate for the vaginal approach, we quadruple the cost of the surgery. Consider that we perform roughly 500,000 hysterectomies every year, and you can see how costs mount rapidly.

OBG Management: What are some of the other problems afflicting the US health-care system?

Dr. Levy: There are tremendous disparities in quality and cost across the country. Why? How we spend money in health care is cultural. It’s influenced by what we become accustomed to, what our particular environment calls “standard.” Here’s an example: A man who is experiencing knee pain tries to make an appointment with an orthopedic surgeon, but when he telephones the physician’s office, he is told that he can’t make an appointment until he has an MRI. That’s cultural, not medically justified.

Patients also play a role. When the patient comes in with a ream of paper from the Internet, and she wants a CA 125 test because she thinks it’s somehow going to prevent ovarian cancer, we need to explain to her, in a way she can understand, that adding that testing is of no benefit and may actually cause harm. We need quick statements that can help defuse the demand for increased testing.

Role of the government

OBG Management: What role does the government play?

Dr. Levy: The Medicare Resource-Based Relative Value Scale (RBRVS) was enacted into law in 1992. Most payers now follow this scale to determine reimbursement, based on how many resources it requires to perform a service. Resources are defined in the law—we can’t change them. But the American Medical Association did convene the RBRVS Update Committee (RUC), of which I am the chair, to do the best we can to define for the federal government exactly how many of those resources are necessary for a particular intervention. For example, how much time does it really take to perform laparoscopic supracervical hysterectomy—and how does that compare with reading a computed tomography (CT) scan of the abdomen and pelvis or with performing a five-vessel bypass? How many office visits for hypertension does it take to equal an open-heart surgery and 90 days of care? That’s not an easy set of relative intensities to work through, but the RUC does do that and makes recommendations to CMS for the relative value units (RVUs) for the services we provide.

OBG Management: Is it time alone that determines the value of a service?

Dr. Levy: Physician work is defined as the time it takes to perform a procedure—but also as the intensity of that service as compared with other physician services.

There are also practice-expense RVUs, intended to address the cost of clinical staff, medical supplies, and equipment. Right now approximately 52% of reimbursement goes toward the practice-expense component, and less than 50% for the physician’s work.

In 1992, when the RBRVS was enacted, women’s health services were significantly undervalued because ObGyns did not form a large part of the Medicare fee schedule. Over the past 20 years, ACOG and the RUC have worked diligently to correct those initial inequities.

On the RUC, we believe that no physicians are paid at a level that is fair and appropriate, compared with a plumber or electrician. So the shift to a value-based system and away from the volume-based system may be beneficial to us.

Challenges ahead

OBG Management: What challenges do ObGyns face in attempting to overcome these problems?

Dr. Levy: The primary challenge is to face reality as it is—not as it was in the “good old days” or as we wish it to be. We need to become advocates for ourselves and our patients. Advocacy would support and promote our patients’ health-care rights and enhance community health. It would also foster policy initiatives that focus on availability, safety, and quality of care.

In our advocacy, we need to focus first on quality. If we don’t define quality ourselves, others are going to decide that quality is a constant and that the only thing that matters is cost, and they will shift all services to the lowest-cost providers. That is not the way we want things to go.

Some changes are already in play:

• Out-of-pocket costs for patients are increasing, motivating patients to become more discriminating
• Payment models will soon focus on “episodes of care,” with incentives for systems to reduce surgical volumes while preserving the patient’s quality of life
• Surgery will shift from low-volume surgeons to high-volume physicians who have demonstrated excellent outcomes. This is otherwise known as “value-based purchasing,” based on a model from Harvard Business School.²

Bundled payments will become the norm

OBG Management: Can you elaborate a bit on episodes of care?

Dr. Levy: By episode of care, I mean bundled payments. For example, pregnancy services where prenatal care, delivery, and postpartum care are bundled, or management of fibroids where the diagnosis, imaging, medical, and, potentially, surgical management could all be included in a single payment. All interventions in these periods would be grouped together and reimbursed at a set rate. As a result, the clinicians caring for the patient during these episodes have more of an incentive to reduce unnecessary costs. Are a first-trimester ultrasound scan and two second-trimester scans really necessary? Or might there be a less expensive way to ensure the same optimal outcome? Are the fibroids symptomatic or might observation be a more appropriate option for the patient?

OBG Management: Some people might assume you are prescribing “cookbook medicine” by urging a reduction in variations in care.

Dr. Levy: Not at all. I’m talking about reducing significant variations in outcomes, not processes. Physicians should remain free to treat the patient, using whatever approach they deem to be in her best interest. However, cost pressures mean that we will need to become more creative in keeping costs down without impairing outcomes.

OBG Management: What will happen if physicians don’t keep these cost pressures in mind?

Dr. Levy: People are already keeping score. CMS and payers are using ICD-9 diagnoses, married to the CPT code—the intervention, as well as the episode—and including the costs of things we may have no idea are being spent, such as pharmaceuticals, a return to the emergency room, and so on. We need to be aware of what other people are measuring. We need to understand what we are being measured on: patient satisfaction, quality of life, morbidity and mortality, and cost.

What can gynecologic surgeons do?

OBG Management: Here’s the million dollar question: What can gynecologic surgeons do about this problem?

Dr. Levy: We need to step up to the plate. We need to read the literature critically to focus on clinically meaningful outcomes. Although small differences in blood loss, analgesic use, or operating times may be statistically significant, they do not produce outcomes that are apparent and meaningful to our patients.

We also need to encourage comparative effectiveness research, which is essential to ensure the most clinically meaningful and cost-effective care.

Now that “DSH” payments—disproportional share, or the incremental amount of money that hospitals collected to reimburse them for care of the uninsured—are going away, hospitals are going to need to cut expenses 20% to 25% over the next 3 years to survive. You can bet they are going to change the way they look at you. Be prepared for them to limit the “toys” you are allowed to have, and other cuts.

OBG Management: Can you recommend specific steps?

Dr. Levy: Yes, we need to:

• think creatively to contain costs. A good book on this subject is Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care, by Marty Makary, MD.³
• track our own outcomes. Although it is irritating and time-consuming to enter data, it’s a little easier with electronic medical records. We need to document our own long-term outcomes. In fact, ACOG is working with the American Board of Obstetrics and Gynecology to look at ways we can create a structure for us to track our own outcomes as part of the maintenance of certification (MOC) process. When you track data, the Hawthorne effect comes into play: You get better at the activity you’re tracking, simply by writing it down.
• collaborate with others in our communities to improve public health issues such as obesity, smoking, and teenage access to contraception
• question and challenge preconceived notions and beliefs. We have a lot of them in surgery. For example, we tell patients not to lift after hysterectomy, not to have sex after hysteroscopic resection—but we have absolutely no data suggesting that these admonitions are helpful. Bowel prep is another example. Data have demonstrated that it not only does not benefit the patient, mechanical prep causes harm—but the randomized, controlled trials documenting this fact appear in the surgical literature, not the gynecologic literature. And guess how long it takes for us to incorporate definitive data like that into gynecologic practice? 17 years.
• get a seat at every table to participate in data definitions, acquisition, and dissemination to inform our daily clinical decisions
• participate in efforts to define and improve quality of care.

OBG Management: Any last comments?

Dr. Levy: I just want to emphasize how important it is that we take control of our destiny. If we are not at the table, we may be on the menu! But if we step up to the plate and approach these challenges the right way, we can become the premier surgical specialty.

We want to hear from you!  Tell us what you think.

Barbara S. Levy, MD, spent 29 years in private practice before accepting an appointment as vice president of health policy at the American College of Obstetricians and Gynecologists (ACOG). Those 29 years in private practice weren’t her only window onto the health-care arena, however. She has served as chair of the Resource Based Relative Value Scale Update Committee for the American Medical Association for 3 years; as medical director of Women’s and Children’s Services at Franciscan Health System in Tacoma, Washington; and as a long-time member of the OBG Management Board of Editors. As a result, she offers an informed and well-rounded perspective on the economics of surgical gynecology—the subject of a keynote address she delivered at the 2012 Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in December.

We sat down with Dr. Levy after her talk to explore some of the issues she raised—the focus of this Q&A. Dr. Levy also summarizes the high points of her talk in a video presentation available at obgmanagement.com.

OBG Management: What prompted you to leave private practice, move across country, and accept the post at ACOG?

Dr. Levy: I had spent the better part of 29 years complaining and feeling reasonably unhappy with what organized medicine was doing—or not doing—for ObGyns and our patients. I felt that the specialty was not really out there in front of the curve, driving the bus, so to speak, but was a victim of broader forces. So when I was given an opportunity to influence the way we approach health-care policy, to enable us to drive our own bus, I decided to take the challenge. I’m not sure I can make a difference, but I’m going to do everything possible to put us in control of our destiny. There are a lot of pitfalls out there, but I think that, given a commitment to doing what is right, we may be able to change the way we deliver health care in this country.

OBG Management: So what’s wrong with the way we deliver health care in the United States?

Dr. Levy: We are spending an inordinate amount of money. I’ve heard it referred to as an “investment,” but I’m not sure that word is accurate. It’s really an expenditure of trillions of dollars—as much as 17% of gross domestic product—but what are we getting in return? We’re not getting what we want or need. There is a lot of innovation out there, but what is it bringing us? Do we have better health care in this country, based on our per capita expenditure, than other developed nations have? The answer is “No.”

OBG Management: Why do you think that is?

Dr. Levy: If you look at the growth in Part B Medicare, and focus on where we’re spending the money, the culprits are pharmaceuticals, a huge increase in testing and imaging, and a sharp rise in office-based procedures. The complexity of services has also increased dramatically. Our population is aging, and obesity is epidemic and driving costs for management of diabetes, hypertension, and chronic heart disease, as well as joint replacements and back surgery. About 85% of Medicare dollars go to the care of 15% to 20% of the Medicare population. Yes, we’re reducing death rates from cardiovascular disease and cancer, but now we have a larger population of patients who have chronic, active disease.

OBG Management: Who’s responsible for this problem?

Dr. Levy: Our health-care systems have created this mess in many ways. We spend $98 billion annually on hospitalization for pregnancy and childbirth, but our mortality rate is increasing. We rank 50th in the world in maternal mortality despite a cesarean delivery rate over 30%, despite all the money that we’re spending—with maternal mortality higher here than in almost every European country, as well as several nations in Asia and the Middle East.¹

OBG Management: Why are we spending so much money?

Dr. Levy: We have become so fearful—of poor outcomes, of litigation, and our patients are coming to us with demands for tests and treatment that cost them little or nothing—that we intervene with tests and procedures that increase the cost of care without providing any true benefit in terms of outcome.

We’ve also made some poor choices. We’ve allowed ourselves to be the victims of legislation, of rule-making, because we don’t sit down and read the 1,300 or so pages in the Federal Register from the Centers for Medicare and Medicaid Services (CMS) on proposed rule-making every year. Things happen to us that we aren’t aware of. We have allowed ourselves to be drawn in by innovation, by testing, and by fear until we have begun to do things that may not have any real benefit for our patients.

Both physicians and hospitals have driven volume to increase reimbursement. And industry has been drawn into the mix because the medical field is the only one that’s expanding. We have become our own worst enemies. We have not stepped up to the plate to define quality and value, so now others are doing it—and they don’t necessarily use the same definitions we do. We have allowed our fears of liability and misperceptions about the value of procedures to drive our decisions. For example, when we perform robotic hysterectomy in a woman who is a great candidate for the vaginal approach, we quadruple the cost of the surgery. Consider that we perform roughly 500,000 hysterectomies every year, and you can see how costs mount rapidly.

OBG Management: What are some of the other problems afflicting the US health-care system?

Dr. Levy: There are tremendous disparities in quality and cost across the country. Why? How we spend money in health care is cultural. It’s influenced by what we become accustomed to, what our particular environment calls “standard.” Here’s an example: A man who is experiencing knee pain tries to make an appointment with an orthopedic surgeon, but when he telephones the physician’s office, he is told that he can’t make an appointment until he has an MRI. That’s cultural, not medically justified.

Patients also play a role. When the patient comes in with a ream of paper from the Internet, and she wants a CA 125 test because she thinks it’s somehow going to prevent ovarian cancer, we need to explain to her, in a way she can understand, that adding that testing is of no benefit and may actually cause harm. We need quick statements that can help defuse the demand for increased testing.

Role of the government

OBG Management: What role does the government play?

Dr. Levy: The Medicare Resource-Based Relative Value Scale (RBRVS) was enacted into law in 1992. Most payers now follow this scale to determine reimbursement, based on how many resources it requires to perform a service. Resources are defined in the law—we can’t change them. But the American Medical Association did convene the RBRVS Update Committee (RUC), of which I am the chair, to do the best we can to define for the federal government exactly how many of those resources are necessary for a particular intervention. For example, how much time does it really take to perform laparoscopic supracervical hysterectomy—and how does that compare with reading a computed tomography (CT) scan of the abdomen and pelvis or with performing a five-vessel bypass? How many office visits for hypertension does it take to equal an open-heart surgery and 90 days of care? That’s not an easy set of relative intensities to work through, but the RUC does do that and makes recommendations to CMS for the relative value units (RVUs) for the services we provide.

OBG Management: Is it time alone that determines the value of a service?

Dr. Levy: Physician work is defined as the time it takes to perform a procedure—but also as the intensity of that service as compared with other physician services.

There are also practice-expense RVUs, intended to address the cost of clinical staff, medical supplies, and equipment. Right now approximately 52% of reimbursement goes toward the practice-expense component, and less than 50% for the physician’s work.

In 1992, when the RBRVS was enacted, women’s health services were significantly undervalued because ObGyns did not form a large part of the Medicare fee schedule. Over the past 20 years, ACOG and the RUC have worked diligently to correct those initial inequities.

On the RUC, we believe that no physicians are paid at a level that is fair and appropriate, compared with a plumber or electrician. So the shift to a value-based system and away from the volume-based system may be beneficial to us.

Challenges ahead

OBG Management: What challenges do ObGyns face in attempting to overcome these problems?

Dr. Levy: The primary challenge is to face reality as it is—not as it was in the “good old days” or as we wish it to be. We need to become advocates for ourselves and our patients. Advocacy would support and promote our patients’ health-care rights and enhance community health. It would also foster policy initiatives that focus on availability, safety, and quality of care.

In our advocacy, we need to focus first on quality. If we don’t define quality ourselves, others are going to decide that quality is a constant and that the only thing that matters is cost, and they will shift all services to the lowest-cost providers. That is not the way we want things to go.

Some changes are already in play:

• Out-of-pocket costs for patients are increasing, motivating patients to become more discriminating
• Payment models will soon focus on “episodes of care,” with incentives for systems to reduce surgical volumes while preserving the patient’s quality of life
• Surgery will shift from low-volume surgeons to high-volume physicians who have demonstrated excellent outcomes. This is otherwise known as “value-based purchasing,” based on a model from Harvard Business School.²

Bundled payments will become the norm

OBG Management: Can you elaborate a bit on episodes of care?

Dr. Levy: By episode of care, I mean bundled payments. For example, pregnancy services where prenatal care, delivery, and postpartum care are bundled, or management of fibroids where the diagnosis, imaging, medical, and, potentially, surgical management could all be included in a single payment. All interventions in these periods would be grouped together and reimbursed at a set rate. As a result, the clinicians caring for the patient during these episodes have more of an incentive to reduce unnecessary costs. Are a first-trimester ultrasound scan and two second-trimester scans really necessary? Or might there be a less expensive way to ensure the same optimal outcome? Are the fibroids symptomatic or might observation be a more appropriate option for the patient?

OBG Management: Some people might assume you are prescribing “cookbook medicine” by urging a reduction in variations in care.

Dr. Levy: Not at all. I’m talking about reducing significant variations in outcomes, not processes. Physicians should remain free to treat the patient, using whatever approach they deem to be in her best interest. However, cost pressures mean that we will need to become more creative in keeping costs down without impairing outcomes.

OBG Management: What will happen if physicians don’t keep these cost pressures in mind?

Dr. Levy: People are already keeping score. CMS and payers are using ICD-9 diagnoses, married to the CPT code—the intervention, as well as the episode—and including the costs of things we may have no idea are being spent, such as pharmaceuticals, a return to the emergency room, and so on. We need to be aware of what other people are measuring. We need to understand what we are being measured on: patient satisfaction, quality of life, morbidity and mortality, and cost.

What can gynecologic surgeons do?

OBG Management: Here’s the million dollar question: What can gynecologic surgeons do about this problem?

Dr. Levy: We need to step up to the plate. We need to read the literature critically to focus on clinically meaningful outcomes. Although small differences in blood loss, analgesic use, or operating times may be statistically significant, they do not produce outcomes that are apparent and meaningful to our patients.

We also need to encourage comparative effectiveness research, which is essential to ensure the most clinically meaningful and cost-effective care.

Now that “DSH” payments—disproportional share, or the incremental amount of money that hospitals collected to reimburse them for care of the uninsured—are going away, hospitals are going to need to cut expenses 20% to 25% over the next 3 years to survive. You can bet they are going to change the way they look at you. Be prepared for them to limit the “toys” you are allowed to have, and other cuts.

OBG Management: Can you recommend specific steps?

Dr. Levy: Yes, we need to:

• think creatively to contain costs. A good book on this subject is Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care, by Marty Makary, MD.³
• track our own outcomes. Although it is irritating and time-consuming to enter data, it’s a little easier with electronic medical records. We need to document our own long-term outcomes. In fact, ACOG is working with the American Board of Obstetrics and Gynecology to look at ways we can create a structure for us to track our own outcomes as part of the maintenance of certification (MOC) process. When you track data, the Hawthorne effect comes into play: You get better at the activity you’re tracking, simply by writing it down.
• collaborate with others in our communities to improve public health issues such as obesity, smoking, and teenage access to contraception
• question and challenge preconceived notions and beliefs. We have a lot of them in surgery. For example, we tell patients not to lift after hysterectomy, not to have sex after hysteroscopic resection—but we have absolutely no data suggesting that these admonitions are helpful. Bowel prep is another example. Data have demonstrated that it not only does not benefit the patient, mechanical prep causes harm—but the randomized, controlled trials documenting this fact appear in the surgical literature, not the gynecologic literature. And guess how long it takes for us to incorporate definitive data like that into gynecologic practice? 17 years.
• get a seat at every table to participate in data definitions, acquisition, and dissemination to inform our daily clinical decisions
• participate in efforts to define and improve quality of care.

OBG Management: Any last comments?

Dr. Levy: I just want to emphasize how important it is that we take control of our destiny. If we are not at the table, we may be on the menu! But if we step up to the plate and approach these challenges the right way, we can become the premier surgical specialty.

We want to hear from you!  Tell us what you think.

The concept of pathoplasticity—that the presentation of illness varies depending on a patient’s experiences, situation, and background—is not new to psychiatry. Pathoplastic effects of culture on the content manifestation of psychiatric disorders have been documented in the literature.¹ We present a patient with schizophrenia whose hallucinations and delusions incorporated the social networking website Facebook to highlight the role internet culture can play in shaping modern psychiatric phenomena.

Ms. P, age 49, presents to the emergency department with increasing psychosis. At age 20 she was diagnosed with schizophrenia in Puerto Rico, where she was born and raised. One month before her current admission, Ms. P began to have auditory hallucinations of her Facebook “friends,” most of whom live in Puerto Rico. She says she secludes herself in her bedroom with the door closed, but can still hear voices “coming from Facebook.” She describes the voices as emanating from outside her head, from her computer. Ms. P states the voices stop when the computer is off and return as soon as she knows it is back on. The voices sometimes talk to each other, do not provide commentary, and always are derogatory, often commenting on her sexual experiences, mental health, and success as a mother.

Social media and psychiatry

Since the public introduction of the internet in 1991, contemporary culture has become increasingly web-based. Facebook launched in 2004 and now has >1 billion active monthly users, or approximately 14% of the global population.² Previously, patients such as Ms. P would be described as having auditory hallucinations and a dense delusional framework. However, in the setting of Facebook, her story seems less bizarre. Ms. P’s case shows the pathoplastic effect of web-based social media on psychiatric phenomena.

Social media sites could introduce stressful exogenous information and ideas; sudden, intimate relationships with strangers; permeable personal boundaries; and self-exposure to a degree that until recently was unimaginable.³ For psychotic patients, this new form of “real” can multiply the number of imagined enemies and further a perceived conspiracy.

Recognizing pathoplastic changes

As society shifts to an increasingly web-based culture, the role of culturally informed pathoplasticity in psychiatric illness merits renewed focus. The ever-evolving pathoplastic features of mental illness make our work interesting and challenging. Because every patient has a unique life story, no 2 patients will look the same. Taking a history of a patient’s use of web-based technology—including Facebook and other social media—may help explain possible pathoplastic changes in presentation. Ask patients about their use of social networking sites, blogs, and microblogs (eg, Twitter).

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

The concept of pathoplasticity—that the presentation of illness varies depending on a patient’s experiences, situation, and background—is not new to psychiatry. Pathoplastic effects of culture on the content manifestation of psychiatric disorders have been documented in the literature.¹ We present a patient with schizophrenia whose hallucinations and delusions incorporated the social networking website Facebook to highlight the role internet culture can play in shaping modern psychiatric phenomena.

Ms. P, age 49, presents to the emergency department with increasing psychosis. At age 20 she was diagnosed with schizophrenia in Puerto Rico, where she was born and raised. One month before her current admission, Ms. P began to have auditory hallucinations of her Facebook “friends,” most of whom live in Puerto Rico. She says she secludes herself in her bedroom with the door closed, but can still hear voices “coming from Facebook.” She describes the voices as emanating from outside her head, from her computer. Ms. P states the voices stop when the computer is off and return as soon as she knows it is back on. The voices sometimes talk to each other, do not provide commentary, and always are derogatory, often commenting on her sexual experiences, mental health, and success as a mother.

Social media and psychiatry

Since the public introduction of the internet in 1991, contemporary culture has become increasingly web-based. Facebook launched in 2004 and now has >1 billion active monthly users, or approximately 14% of the global population.² Previously, patients such as Ms. P would be described as having auditory hallucinations and a dense delusional framework. However, in the setting of Facebook, her story seems less bizarre. Ms. P’s case shows the pathoplastic effect of web-based social media on psychiatric phenomena.

Social media sites could introduce stressful exogenous information and ideas; sudden, intimate relationships with strangers; permeable personal boundaries; and self-exposure to a degree that until recently was unimaginable.³ For psychotic patients, this new form of “real” can multiply the number of imagined enemies and further a perceived conspiracy.

Recognizing pathoplastic changes

As society shifts to an increasingly web-based culture, the role of culturally informed pathoplasticity in psychiatric illness merits renewed focus. The ever-evolving pathoplastic features of mental illness make our work interesting and challenging. Because every patient has a unique life story, no 2 patients will look the same. Taking a history of a patient’s use of web-based technology—including Facebook and other social media—may help explain possible pathoplastic changes in presentation. Ask patients about their use of social networking sites, blogs, and microblogs (eg, Twitter).

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

The concept of pathoplasticity—that the presentation of illness varies depending on a patient’s experiences, situation, and background—is not new to psychiatry. Pathoplastic effects of culture on the content manifestation of psychiatric disorders have been documented in the literature.¹ We present a patient with schizophrenia whose hallucinations and delusions incorporated the social networking website Facebook to highlight the role internet culture can play in shaping modern psychiatric phenomena.

Ms. P, age 49, presents to the emergency department with increasing psychosis. At age 20 she was diagnosed with schizophrenia in Puerto Rico, where she was born and raised. One month before her current admission, Ms. P began to have auditory hallucinations of her Facebook “friends,” most of whom live in Puerto Rico. She says she secludes herself in her bedroom with the door closed, but can still hear voices “coming from Facebook.” She describes the voices as emanating from outside her head, from her computer. Ms. P states the voices stop when the computer is off and return as soon as she knows it is back on. The voices sometimes talk to each other, do not provide commentary, and always are derogatory, often commenting on her sexual experiences, mental health, and success as a mother.

Social media and psychiatry

Since the public introduction of the internet in 1991, contemporary culture has become increasingly web-based. Facebook launched in 2004 and now has >1 billion active monthly users, or approximately 14% of the global population.² Previously, patients such as Ms. P would be described as having auditory hallucinations and a dense delusional framework. However, in the setting of Facebook, her story seems less bizarre. Ms. P’s case shows the pathoplastic effect of web-based social media on psychiatric phenomena.

Social media sites could introduce stressful exogenous information and ideas; sudden, intimate relationships with strangers; permeable personal boundaries; and self-exposure to a degree that until recently was unimaginable.³ For psychotic patients, this new form of “real” can multiply the number of imagined enemies and further a perceived conspiracy.

Recognizing pathoplastic changes

As society shifts to an increasingly web-based culture, the role of culturally informed pathoplasticity in psychiatric illness merits renewed focus. The ever-evolving pathoplastic features of mental illness make our work interesting and challenging. Because every patient has a unique life story, no 2 patients will look the same. Taking a history of a patient’s use of web-based technology—including Facebook and other social media—may help explain possible pathoplastic changes in presentation. Ask patients about their use of social networking sites, blogs, and microblogs (eg, Twitter).

Disclosure

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

The ever-increasing number of psychiatric visits to emergency room (ER) settings is a daunting clinical challenge.¹ As psychiatrists, we must be prepared for these visits. The mnemonic FIRST can help when you encounter a psychiatric patient in the ER.

Frank conversation about why the patient came to the ER for evaluation and the need for observation or treatment is essential to obtaining an accurate history and providing appropriate care. Address a possible sense of isolation a patient may feel when being in a new environment. Be aware of nonverbal cues because they may lead to an appropriate and well-tailored conversation with your patient.

Individualize care by emphasizing to patients that they have choices in their treatment plan now and after discharge. Listen and communicate with the patient in a manner that decreases stigma because he or she may feel out of control, fearful, angry, or betrayed by loved ones. Doing so will help create a safe environment, can help alleviate the need for chemical or physical restraints, and may enhance treatment adherence.

Reach out to the patient’s family and friends to gather support for him or her and to obtain collateral information to formulate an appropriate course of treatment. Ask about family medical history, financial status, and a social support system because these can aid in diagnosis and optimizing the patient’s short- and long-term prognosis.

Somatic complaints can be used as a springboard to build rapport with patients. Many patients find it easier to talk about physical symptoms than emotional ones, so acknowledge and validate these concerns and explain that many psychiatric symptoms can present as somatic symptoms, such as panic disorder presenting as tachycardia. This also may indicate a need for a prompt, thorough physical examination.

Tease out secondary causes of psychiatric symptoms. Many organic conditions can initially present as psychiatric symptoms; for example, brain tumors or seizures can present with olfactory, gustatory, visual, or auditory hallucinations. Drug toxicology and laboratory testing can rule out medical causes of psychiatric symptoms.¹ Geriatric patients or those with multiple, chronic medical illness can present with agitation, heavy sedation, or delusions. Keep a high index of suspicion to rule out medical conditions.

Discuss this article at www.facebook.com/CurrentPsychiatry

The ever-increasing number of psychiatric visits to emergency room (ER) settings is a daunting clinical challenge.¹ As psychiatrists, we must be prepared for these visits. The mnemonic FIRST can help when you encounter a psychiatric patient in the ER.

Frank conversation about why the patient came to the ER for evaluation and the need for observation or treatment is essential to obtaining an accurate history and providing appropriate care. Address a possible sense of isolation a patient may feel when being in a new environment. Be aware of nonverbal cues because they may lead to an appropriate and well-tailored conversation with your patient.

Individualize care by emphasizing to patients that they have choices in their treatment plan now and after discharge. Listen and communicate with the patient in a manner that decreases stigma because he or she may feel out of control, fearful, angry, or betrayed by loved ones. Doing so will help create a safe environment, can help alleviate the need for chemical or physical restraints, and may enhance treatment adherence.

Reach out to the patient’s family and friends to gather support for him or her and to obtain collateral information to formulate an appropriate course of treatment. Ask about family medical history, financial status, and a social support system because these can aid in diagnosis and optimizing the patient’s short- and long-term prognosis.

Somatic complaints can be used as a springboard to build rapport with patients. Many patients find it easier to talk about physical symptoms than emotional ones, so acknowledge and validate these concerns and explain that many psychiatric symptoms can present as somatic symptoms, such as panic disorder presenting as tachycardia. This also may indicate a need for a prompt, thorough physical examination.

Tease out secondary causes of psychiatric symptoms. Many organic conditions can initially present as psychiatric symptoms; for example, brain tumors or seizures can present with olfactory, gustatory, visual, or auditory hallucinations. Drug toxicology and laboratory testing can rule out medical causes of psychiatric symptoms.¹ Geriatric patients or those with multiple, chronic medical illness can present with agitation, heavy sedation, or delusions. Keep a high index of suspicion to rule out medical conditions.

Discuss this article at www.facebook.com/CurrentPsychiatry

The ever-increasing number of psychiatric visits to emergency room (ER) settings is a daunting clinical challenge.¹ As psychiatrists, we must be prepared for these visits. The mnemonic FIRST can help when you encounter a psychiatric patient in the ER.

Frank conversation about why the patient came to the ER for evaluation and the need for observation or treatment is essential to obtaining an accurate history and providing appropriate care. Address a possible sense of isolation a patient may feel when being in a new environment. Be aware of nonverbal cues because they may lead to an appropriate and well-tailored conversation with your patient.

Individualize care by emphasizing to patients that they have choices in their treatment plan now and after discharge. Listen and communicate with the patient in a manner that decreases stigma because he or she may feel out of control, fearful, angry, or betrayed by loved ones. Doing so will help create a safe environment, can help alleviate the need for chemical or physical restraints, and may enhance treatment adherence.

Reach out to the patient’s family and friends to gather support for him or her and to obtain collateral information to formulate an appropriate course of treatment. Ask about family medical history, financial status, and a social support system because these can aid in diagnosis and optimizing the patient’s short- and long-term prognosis.

Somatic complaints can be used as a springboard to build rapport with patients. Many patients find it easier to talk about physical symptoms than emotional ones, so acknowledge and validate these concerns and explain that many psychiatric symptoms can present as somatic symptoms, such as panic disorder presenting as tachycardia. This also may indicate a need for a prompt, thorough physical examination.

Tease out secondary causes of psychiatric symptoms. Many organic conditions can initially present as psychiatric symptoms; for example, brain tumors or seizures can present with olfactory, gustatory, visual, or auditory hallucinations. Drug toxicology and laboratory testing can rule out medical causes of psychiatric symptoms.¹ Geriatric patients or those with multiple, chronic medical illness can present with agitation, heavy sedation, or delusions. Keep a high index of suspicion to rule out medical conditions.

Most evidence supporting antipsychotics as a treatment for migraine headaches and cluster headaches is based on small studies and chart reviews. Some research suggests antipsychotics may effectively treat nausea but side effects such as akathisia may limit their use.

Migraine headaches

Antipsychotic treatment of migraines is supported by the theory that dopaminergic hyperactivity leads to migraine headaches (Table 1). Antipsychotics have been used off-label in migraine patients who do not tolerate triptans or have status migrainosus—intense, debilitating migraine lasting >72 hours.¹ Primarily a result of D2 receptor blockade, the serotonergic effects of some second-generation antipsychotics (SGAs) may prevent migraine recurrence. The first-generation antipsychotics (FGAs) prochlorperazine, droperidol, haloperidol, and chlorpromazine have been used for migraine headaches (Table 2).^1-27

Prochlorperazine may be an effective treatment of acute headaches⁹ and refractory chronic daily headache.¹⁰ Studies show that buccal prochlorperazine is more effective than oral ergotamine tartrate¹¹ and IV prochlorperazine is more effective than IV ketorolac¹² or valproate²⁸ for treating acute headache.

Evidence suggests that chlorpromazine administered IM² or IV³ is better than placebo for managing migraine pain. In a study comparing IV chlorpromazine, lidocaine, and dihydroergotamine, patients treated with chlorpromazine showed more persistent headache relief 12 to 24 hours post-dose.⁴ In another study, IV chlorpromazine, 25 mg, was as effective as IM ketorolac, 60 mg.⁵

Droperidol has been shown to be effective for managing headache, specifically status migrainosus.⁶ Patients with “benign headache”—headache not caused by an underlying medical disorder—who received droperidol reported greater reduction in visual analog pain scores within 1 hour of dosing compared with those taking prochlorperazine.⁷ In a randomized trial comparing IM droperidol and IM meperidine, patients with an acute migraine who received droperidol had improved scores on the visual pain analog scale and required less “rescue medication” for breakthrough pain.⁸ The FDA has issued a “black-box” warning of QTc prolongation with droperidol.

In a double blind, placebo-controlled trial, IV haloperidol, 5 mg, effectively treated migraine headache in 80% of patients compared with 15% of those who received placebo. However, 16% of patients considered the side effects—mainly sedation and akathisia—intolerable and 7% had symptom relapse.¹³ In an open-label trial of 6 patients with migraine headache, all patients achieved complete or substantial headache relief 25 to 65 minutes after receiving IV haloperidol, 5 mg.¹⁴

SGAs often antagonize 5-HT1D receptors and theoretically can render triptan therapy—which stimulates pre-synaptic 5-HT1D receptors—ineffective. This has not been seen clinically and instead, dose-related, non-specific headaches are a common adverse event with SGAs.^29,30 A retrospective chart review found olanzapine provided relief for refractory headaches in patients who had failed ≥4 preventive medications. Olanzapine significantly decreased headache days, from 27.5±4.9 before treatment to 21.1±10.7 after treatment. Olanzapine also improved headache severity (measured on a 0 to 10 scale) from 8.7±1.6 before treatment to 2.2±2.1 after treatment.¹⁶ Researchers found that 2.5 or 5 mg of olanzapine relieved acute migraines for most patients, with repeat dosing as needed up to 20 mg/d. For prophylactic treatment, 5 or 10 mg of olanzapine was used. Olanzapine’s antinociceptive effect may be related to its action on α-2 adrenoreceptors and to a lesser extent on involvement of opioid and serotonergic receptors.¹⁷

In a case series, 3 migraine patients who met criteria for chronic daily headache and migraines but did not have a psychiatric disorder reported significant and sustained headache improvement when treated with risperidone.¹⁹ In a case series of 3 migraine patients with co-occurring psychiatric disorders, aripiprazole decreased migraine frequency and severity.¹⁵ Although limited data support quetiapine’s efficacy in treating acute migraines, in an open-label, pilot study, patients taking quetiapine, 25 to 75 mg/d, demonstrated a decrease in mean frequency of migraine days from 10.2 to 6.2 and decreased use of rescue medications from 2.3 to 1.2 days per week.¹⁸

Table 1

Possible rationale for antipsychotic use for headaches and nausea

Table 2

Antipsychotics for headache and nausea: Strength of the evidence

Cluster headaches

Subcutaneous sumatriptan and inhaled oxygen are first-line treatments for cluster headaches.³¹ A single, small study²⁰ reported that chlorpromazine may prevent cluster headaches, which suggests that D2 receptor blockade may treat such headaches. However, limited supporting evidence relegates its use to a second- or third-line therapy.

In an open-label study (N = 5), olanzapine provided some relief of pain associated with cluster headache within 20 minutes of administration.²² In another study, patients with schizophrenia and comorbid cluster headaches improved with olanzapine.²¹

Because evidence is limited to small prospective studies, antipsychotic treatment of cluster headache is not well established.^20-22 However, olanzapine may benefit patients with comorbid cluster headaches and schizophrenia.

Nausea

The signaling pathways that mediate emesis involve 5-HT3, D2, muscarinic, and histamine receptors.³² Before 5-HT3 antagonists were available, the FGAs metoclopramide, droperidol, prochlorperazine, and promethazine were used to manage acute emesis in emergency departments.²³ A double-blind, placebo-controlled trial found IV droperidol, 1.25 mg, was more effective than metoclopramide, 10 mg, or prochlorperazine, 10 mg, for relieving moderate to severe nausea in adult patients.²³ However, droperidol and prochlorperazine were associated with akathisia. In addition, this trial did not find a clinically significant difference between groups—including placebo—in anxiety, sedation, or need for rescue medications.²³ Use of droperidol to treat nausea decreased after the drug received a “black-box” warning for QT prolongation and torsades de pointes.

Metoclopramide is effective for treating acute migraine and associated nausea²⁴ and has been used to treat gastroparesis because of its effect on upper GI motility. Phenothiazines have been used to treat nausea and studies have shown prochlorperazine to be more effective than promethazine.²⁵ Some studies of prochlorperazine have reported a 44% incidence of akathisia, which limits the drug’s use in patients who may be sensitive to such effects.³³ Promethazine can cause sedation and risk of tissue necrosis at the injection site.³⁴

Among SGAs, olanzapine effectively prevented acute and delayed chemotherapy-induced nausea and vomiting in a proof-of-concept study of patients receiving high and moderate emetogenic therapies.^26,27 National Comprehensive Cancer Network guidelines cite olanzapine as a potential option for treating refractory and breakthrough emesis.³⁵ In a small study (N = 50), olanzapine showed comparable anti-nausea effect to aprepitant—a neurokinin 1 receptor antagonist—and effectively prevented chemotherapy-induced nausea and vomiting in highly emetogenic chemotherapy.³⁶

Related Resources

• Kelley NE, Tepper DE. Rescue therapy for acute migraine, part 2: neuroleptics, antihistamines, and others. Headache. 2012;52(2):292-306.
• Dusitanond P, Young WB. Neuroleptics and migraine. Cent Nerv Syst Agents Med Chem. 2009;9(1):63-70.

Drug Brand Names

• Aprepitant • Emend
• Aripiprazole • Abilify
• Chlorpromazine • Thorazine
• Dihydroergotamine • D.H.E 45
• Droperidol • Inapsine
• Ergotamine tartrate • Ergostat
• Haloperidol • Haldol
• Ketorolac • Toradol
• Lidocaine • Xylocaine, Lidoderm
• Meperidine • Demerol
• Metoclopramide • Reglan
• Olanzapine • Zyprexa
• Prochlorperazine • Compazine
• Promethazine • Phenergan
• Quetiapine • Seroquel
• Risperidone • Risperdal
• Sumatriptan • Imitrex
• Valproate • Depakote

Disclosures

Dr. Macaluso has received grant or research support from EnVivo Pharmaceuticals, Janssen L.P., and Pfizer, Inc.

Dr. Tripathi reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Most evidence supporting antipsychotics as a treatment for migraine headaches and cluster headaches is based on small studies and chart reviews. Some research suggests antipsychotics may effectively treat nausea but side effects such as akathisia may limit their use.

Migraine headaches

Antipsychotic treatment of migraines is supported by the theory that dopaminergic hyperactivity leads to migraine headaches (Table 1). Antipsychotics have been used off-label in migraine patients who do not tolerate triptans or have status migrainosus—intense, debilitating migraine lasting >72 hours.¹ Primarily a result of D2 receptor blockade, the serotonergic effects of some second-generation antipsychotics (SGAs) may prevent migraine recurrence. The first-generation antipsychotics (FGAs) prochlorperazine, droperidol, haloperidol, and chlorpromazine have been used for migraine headaches (Table 2).^1-27

Prochlorperazine may be an effective treatment of acute headaches⁹ and refractory chronic daily headache.¹⁰ Studies show that buccal prochlorperazine is more effective than oral ergotamine tartrate¹¹ and IV prochlorperazine is more effective than IV ketorolac¹² or valproate²⁸ for treating acute headache.

Evidence suggests that chlorpromazine administered IM² or IV³ is better than placebo for managing migraine pain. In a study comparing IV chlorpromazine, lidocaine, and dihydroergotamine, patients treated with chlorpromazine showed more persistent headache relief 12 to 24 hours post-dose.⁴ In another study, IV chlorpromazine, 25 mg, was as effective as IM ketorolac, 60 mg.⁵

Droperidol has been shown to be effective for managing headache, specifically status migrainosus.⁶ Patients with “benign headache”—headache not caused by an underlying medical disorder—who received droperidol reported greater reduction in visual analog pain scores within 1 hour of dosing compared with those taking prochlorperazine.⁷ In a randomized trial comparing IM droperidol and IM meperidine, patients with an acute migraine who received droperidol had improved scores on the visual pain analog scale and required less “rescue medication” for breakthrough pain.⁸ The FDA has issued a “black-box” warning of QTc prolongation with droperidol.

In a double blind, placebo-controlled trial, IV haloperidol, 5 mg, effectively treated migraine headache in 80% of patients compared with 15% of those who received placebo. However, 16% of patients considered the side effects—mainly sedation and akathisia—intolerable and 7% had symptom relapse.¹³ In an open-label trial of 6 patients with migraine headache, all patients achieved complete or substantial headache relief 25 to 65 minutes after receiving IV haloperidol, 5 mg.¹⁴

SGAs often antagonize 5-HT1D receptors and theoretically can render triptan therapy—which stimulates pre-synaptic 5-HT1D receptors—ineffective. This has not been seen clinically and instead, dose-related, non-specific headaches are a common adverse event with SGAs.^29,30 A retrospective chart review found olanzapine provided relief for refractory headaches in patients who had failed ≥4 preventive medications. Olanzapine significantly decreased headache days, from 27.5±4.9 before treatment to 21.1±10.7 after treatment. Olanzapine also improved headache severity (measured on a 0 to 10 scale) from 8.7±1.6 before treatment to 2.2±2.1 after treatment.¹⁶ Researchers found that 2.5 or 5 mg of olanzapine relieved acute migraines for most patients, with repeat dosing as needed up to 20 mg/d. For prophylactic treatment, 5 or 10 mg of olanzapine was used. Olanzapine’s antinociceptive effect may be related to its action on α-2 adrenoreceptors and to a lesser extent on involvement of opioid and serotonergic receptors.¹⁷

In a case series, 3 migraine patients who met criteria for chronic daily headache and migraines but did not have a psychiatric disorder reported significant and sustained headache improvement when treated with risperidone.¹⁹ In a case series of 3 migraine patients with co-occurring psychiatric disorders, aripiprazole decreased migraine frequency and severity.¹⁵ Although limited data support quetiapine’s efficacy in treating acute migraines, in an open-label, pilot study, patients taking quetiapine, 25 to 75 mg/d, demonstrated a decrease in mean frequency of migraine days from 10.2 to 6.2 and decreased use of rescue medications from 2.3 to 1.2 days per week.¹⁸

Table 1

Possible rationale for antipsychotic use for headaches and nausea

Table 2

Antipsychotics for headache and nausea: Strength of the evidence

Cluster headaches

Subcutaneous sumatriptan and inhaled oxygen are first-line treatments for cluster headaches.³¹ A single, small study²⁰ reported that chlorpromazine may prevent cluster headaches, which suggests that D2 receptor blockade may treat such headaches. However, limited supporting evidence relegates its use to a second- or third-line therapy.

In an open-label study (N = 5), olanzapine provided some relief of pain associated with cluster headache within 20 minutes of administration.²² In another study, patients with schizophrenia and comorbid cluster headaches improved with olanzapine.²¹

Because evidence is limited to small prospective studies, antipsychotic treatment of cluster headache is not well established.^20-22 However, olanzapine may benefit patients with comorbid cluster headaches and schizophrenia.

Nausea

The signaling pathways that mediate emesis involve 5-HT3, D2, muscarinic, and histamine receptors.³² Before 5-HT3 antagonists were available, the FGAs metoclopramide, droperidol, prochlorperazine, and promethazine were used to manage acute emesis in emergency departments.²³ A double-blind, placebo-controlled trial found IV droperidol, 1.25 mg, was more effective than metoclopramide, 10 mg, or prochlorperazine, 10 mg, for relieving moderate to severe nausea in adult patients.²³ However, droperidol and prochlorperazine were associated with akathisia. In addition, this trial did not find a clinically significant difference between groups—including placebo—in anxiety, sedation, or need for rescue medications.²³ Use of droperidol to treat nausea decreased after the drug received a “black-box” warning for QT prolongation and torsades de pointes.

Metoclopramide is effective for treating acute migraine and associated nausea²⁴ and has been used to treat gastroparesis because of its effect on upper GI motility. Phenothiazines have been used to treat nausea and studies have shown prochlorperazine to be more effective than promethazine.²⁵ Some studies of prochlorperazine have reported a 44% incidence of akathisia, which limits the drug’s use in patients who may be sensitive to such effects.³³ Promethazine can cause sedation and risk of tissue necrosis at the injection site.³⁴

Among SGAs, olanzapine effectively prevented acute and delayed chemotherapy-induced nausea and vomiting in a proof-of-concept study of patients receiving high and moderate emetogenic therapies.^26,27 National Comprehensive Cancer Network guidelines cite olanzapine as a potential option for treating refractory and breakthrough emesis.³⁵ In a small study (N = 50), olanzapine showed comparable anti-nausea effect to aprepitant—a neurokinin 1 receptor antagonist—and effectively prevented chemotherapy-induced nausea and vomiting in highly emetogenic chemotherapy.³⁶

Related Resources

• Kelley NE, Tepper DE. Rescue therapy for acute migraine, part 2: neuroleptics, antihistamines, and others. Headache. 2012;52(2):292-306.
• Dusitanond P, Young WB. Neuroleptics and migraine. Cent Nerv Syst Agents Med Chem. 2009;9(1):63-70.

Drug Brand Names

• Aprepitant • Emend
• Aripiprazole • Abilify
• Chlorpromazine • Thorazine
• Dihydroergotamine • D.H.E 45
• Droperidol • Inapsine
• Ergotamine tartrate • Ergostat
• Haloperidol • Haldol
• Ketorolac • Toradol
• Lidocaine • Xylocaine, Lidoderm
• Meperidine • Demerol
• Metoclopramide • Reglan
• Olanzapine • Zyprexa
• Prochlorperazine • Compazine
• Promethazine • Phenergan
• Quetiapine • Seroquel
• Risperidone • Risperdal
• Sumatriptan • Imitrex
• Valproate • Depakote

Disclosures

Dr. Macaluso has received grant or research support from EnVivo Pharmaceuticals, Janssen L.P., and Pfizer, Inc.

Dr. Tripathi reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Most evidence supporting antipsychotics as a treatment for migraine headaches and cluster headaches is based on small studies and chart reviews. Some research suggests antipsychotics may effectively treat nausea but side effects such as akathisia may limit their use.

Migraine headaches

Antipsychotic treatment of migraines is supported by the theory that dopaminergic hyperactivity leads to migraine headaches (Table 1). Antipsychotics have been used off-label in migraine patients who do not tolerate triptans or have status migrainosus—intense, debilitating migraine lasting >72 hours.¹ Primarily a result of D2 receptor blockade, the serotonergic effects of some second-generation antipsychotics (SGAs) may prevent migraine recurrence. The first-generation antipsychotics (FGAs) prochlorperazine, droperidol, haloperidol, and chlorpromazine have been used for migraine headaches (Table 2).^1-27

Prochlorperazine may be an effective treatment of acute headaches⁹ and refractory chronic daily headache.¹⁰ Studies show that buccal prochlorperazine is more effective than oral ergotamine tartrate¹¹ and IV prochlorperazine is more effective than IV ketorolac¹² or valproate²⁸ for treating acute headache.

Evidence suggests that chlorpromazine administered IM² or IV³ is better than placebo for managing migraine pain. In a study comparing IV chlorpromazine, lidocaine, and dihydroergotamine, patients treated with chlorpromazine showed more persistent headache relief 12 to 24 hours post-dose.⁴ In another study, IV chlorpromazine, 25 mg, was as effective as IM ketorolac, 60 mg.⁵

Droperidol has been shown to be effective for managing headache, specifically status migrainosus.⁶ Patients with “benign headache”—headache not caused by an underlying medical disorder—who received droperidol reported greater reduction in visual analog pain scores within 1 hour of dosing compared with those taking prochlorperazine.⁷ In a randomized trial comparing IM droperidol and IM meperidine, patients with an acute migraine who received droperidol had improved scores on the visual pain analog scale and required less “rescue medication” for breakthrough pain.⁸ The FDA has issued a “black-box” warning of QTc prolongation with droperidol.

In a double blind, placebo-controlled trial, IV haloperidol, 5 mg, effectively treated migraine headache in 80% of patients compared with 15% of those who received placebo. However, 16% of patients considered the side effects—mainly sedation and akathisia—intolerable and 7% had symptom relapse.¹³ In an open-label trial of 6 patients with migraine headache, all patients achieved complete or substantial headache relief 25 to 65 minutes after receiving IV haloperidol, 5 mg.¹⁴

SGAs often antagonize 5-HT1D receptors and theoretically can render triptan therapy—which stimulates pre-synaptic 5-HT1D receptors—ineffective. This has not been seen clinically and instead, dose-related, non-specific headaches are a common adverse event with SGAs.^29,30 A retrospective chart review found olanzapine provided relief for refractory headaches in patients who had failed ≥4 preventive medications. Olanzapine significantly decreased headache days, from 27.5±4.9 before treatment to 21.1±10.7 after treatment. Olanzapine also improved headache severity (measured on a 0 to 10 scale) from 8.7±1.6 before treatment to 2.2±2.1 after treatment.¹⁶ Researchers found that 2.5 or 5 mg of olanzapine relieved acute migraines for most patients, with repeat dosing as needed up to 20 mg/d. For prophylactic treatment, 5 or 10 mg of olanzapine was used. Olanzapine’s antinociceptive effect may be related to its action on α-2 adrenoreceptors and to a lesser extent on involvement of opioid and serotonergic receptors.¹⁷

In a case series, 3 migraine patients who met criteria for chronic daily headache and migraines but did not have a psychiatric disorder reported significant and sustained headache improvement when treated with risperidone.¹⁹ In a case series of 3 migraine patients with co-occurring psychiatric disorders, aripiprazole decreased migraine frequency and severity.¹⁵ Although limited data support quetiapine’s efficacy in treating acute migraines, in an open-label, pilot study, patients taking quetiapine, 25 to 75 mg/d, demonstrated a decrease in mean frequency of migraine days from 10.2 to 6.2 and decreased use of rescue medications from 2.3 to 1.2 days per week.¹⁸

Table 1

Possible rationale for antipsychotic use for headaches and nausea

Table 2

Antipsychotics for headache and nausea: Strength of the evidence

Cluster headaches

Subcutaneous sumatriptan and inhaled oxygen are first-line treatments for cluster headaches.³¹ A single, small study²⁰ reported that chlorpromazine may prevent cluster headaches, which suggests that D2 receptor blockade may treat such headaches. However, limited supporting evidence relegates its use to a second- or third-line therapy.

In an open-label study (N = 5), olanzapine provided some relief of pain associated with cluster headache within 20 minutes of administration.²² In another study, patients with schizophrenia and comorbid cluster headaches improved with olanzapine.²¹

Because evidence is limited to small prospective studies, antipsychotic treatment of cluster headache is not well established.^20-22 However, olanzapine may benefit patients with comorbid cluster headaches and schizophrenia.

Nausea

The signaling pathways that mediate emesis involve 5-HT3, D2, muscarinic, and histamine receptors.³² Before 5-HT3 antagonists were available, the FGAs metoclopramide, droperidol, prochlorperazine, and promethazine were used to manage acute emesis in emergency departments.²³ A double-blind, placebo-controlled trial found IV droperidol, 1.25 mg, was more effective than metoclopramide, 10 mg, or prochlorperazine, 10 mg, for relieving moderate to severe nausea in adult patients.²³ However, droperidol and prochlorperazine were associated with akathisia. In addition, this trial did not find a clinically significant difference between groups—including placebo—in anxiety, sedation, or need for rescue medications.²³ Use of droperidol to treat nausea decreased after the drug received a “black-box” warning for QT prolongation and torsades de pointes.

Metoclopramide is effective for treating acute migraine and associated nausea²⁴ and has been used to treat gastroparesis because of its effect on upper GI motility. Phenothiazines have been used to treat nausea and studies have shown prochlorperazine to be more effective than promethazine.²⁵ Some studies of prochlorperazine have reported a 44% incidence of akathisia, which limits the drug’s use in patients who may be sensitive to such effects.³³ Promethazine can cause sedation and risk of tissue necrosis at the injection site.³⁴

Among SGAs, olanzapine effectively prevented acute and delayed chemotherapy-induced nausea and vomiting in a proof-of-concept study of patients receiving high and moderate emetogenic therapies.^26,27 National Comprehensive Cancer Network guidelines cite olanzapine as a potential option for treating refractory and breakthrough emesis.³⁵ In a small study (N = 50), olanzapine showed comparable anti-nausea effect to aprepitant—a neurokinin 1 receptor antagonist—and effectively prevented chemotherapy-induced nausea and vomiting in highly emetogenic chemotherapy.³⁶

Related Resources

• Kelley NE, Tepper DE. Rescue therapy for acute migraine, part 2: neuroleptics, antihistamines, and others. Headache. 2012;52(2):292-306.
• Dusitanond P, Young WB. Neuroleptics and migraine. Cent Nerv Syst Agents Med Chem. 2009;9(1):63-70.

Drug Brand Names

• Aprepitant • Emend
• Aripiprazole • Abilify
• Chlorpromazine • Thorazine
• Dihydroergotamine • D.H.E 45
• Droperidol • Inapsine
• Ergotamine tartrate • Ergostat
• Haloperidol • Haldol
• Ketorolac • Toradol
• Lidocaine • Xylocaine, Lidoderm
• Meperidine • Demerol
• Metoclopramide • Reglan
• Olanzapine • Zyprexa
• Prochlorperazine • Compazine
• Promethazine • Phenergan
• Quetiapine • Seroquel
• Risperidone • Risperdal
• Sumatriptan • Imitrex
• Valproate • Depakote

Disclosures

Dr. Macaluso has received grant or research support from EnVivo Pharmaceuticals, Janssen L.P., and Pfizer, Inc.

Dr. Tripathi reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

In 2000, the American Board of Medical Specialties (ABMS) made a commitment to develop a maintenance of certification (MOC) system for their 24 specialty boards. MOC aims to keep physicians up to date because medical knowledge and practice are rapidly evolving and health care systems expect greater accountability linked with performance and outcomes. Previously, board certification for most specialties was limited to a 1-time board exam; upon passing, a clinician was considered board certified for life. The American Board of Psychiatry and Neurology (ABPN) first issued time-limited certificates for board certification in 1994; 2007 was the first year of initial MOC enrollment for ABPN. Diplomates whose certificates were issued before October 1, 1994 are not required to participate in the MOC program.

The ABPN time-limited certificates are on 10-year cycles and require diplomates to fulfill 4 MOC program components: Professional Standing, Self-Assessment and Continuing Medical Education (CME), Cognitive Expertise, and Performance in Practice (PIP) (Table).¹ Requirement details are available at www.abpn.com.

The ABMS MOC initiative is closely aligned with other initiatives, such as maintenance of licensure (MOL), that will impact all physicians, including those who are not board certified and those who were certified before October 1, 1994 and therefore not required to participate in MOC. Licensure, reimbursement, and institutional credentials are developing required measures based on self-assessment and performance.

Table

Maintenance of certification: 4 components

MOC requirements

The ABMS developed its MOC program around 6 general competencies identified by the Accreditation Council for Graduate Medical Education:

• professionalism
  
• patient care and procedural skills
  
• medical knowledge
  
• practice-based learning and improvement
  
• interpersonal and communications skills
  
• systems-based practice.
  

Physicians with “lifetime” certificates are not required to participate in MOC; there are no consequences for physicians who are not required to participate in MOC and choose not to participate, because MOC is a voluntary system. Physicians with time-limited certificates can choose not to participate, but would forfeit their certification. Physicians with certifications in multiple specialties may consider the value of maintaining all of their certifications because it would require them to participate in multiple MOC programs.

Two of the 4 parts of MOC (Parts I and III) are extensions of existing board certification requirements. Part I stipulates a diplomate hold a valid and unrestricted license in ≥1 states or jurisdictions in the United States, its territories, or Canada. Part III (Cognitive Expertise) requires that he or she must pass a cognitive examination every 10 years. To qualify to take the cognitive exam, a diplomate must meet all current MOC requirements.

Parts II and IV integrate continuing education, self-assessment, and the ability to apply both to practice improvements. Part II requires an average of 8 CME credit hours that include a self-assessment component; this likely would eliminate most traditional CME activities. The ABPN stipulates that feedback from the self-assessment must include a comparison with peers and specific literature recommendations for each question in the self-assessment. A small but growing number of accredited CME providers have developed self-directed CME activities that meet these criteria. As of 2014, only ABPN-approved self-assessment activities can be used to meet Part II requirements.

Part IV, the PIP activity, has raised the most concern. The PIP component focuses on quality improvement in 2 parts: a clinical module and a feedback module. This targets active clinicians, and both modules focus on quality improvement activities. The clinical module consists of a baseline chart review by the physician MOC applicant in which results are compared with best practices or practice guidelines. The practitioner-applicant repeats a second chart review after a period of time to determine if intervening practice improvements had a positive impact.

The feedback module consists of reviews of clinical performance by patients, peers, or other second parties such as other practice staff or administrators. These are repeated after a period of time to determine whether practice improvements have been effective.

The PIP model (assessment, practice improvement, reassessment) parallels requirements for Performance Improvement CME (PICME) activities. The American Medical Association (AMA) developed PICME at approximately the same time ABMS was creating MOC. PICME is aimed at changing physician behavior within the context of their clinical practice and is divided into 3 stages:

• Stage A: learning from current practice performance assessment
  
• Stage B: learning from the application of performance improvement to patient care
  
• Stage C: learning from the evaluation of the PICME effort.
  

For example, a coalition of academic, nonprofit, and business organizations—the NOW Coalition for Bipolar Disorder— developed an online quality improvement activity (see Related Resources), which the ABPN certified for assessment and PIP points. It also is certified for 20 points toward the Self-Evaluation of Practice Performance MOC requirement through the American Board of Internal Medicine’s Approved Quality Improvement Pathway, 20 AMA PRA Category 1 Credits™, and 20 Prescribed Credits by the AAFP. Many physicians hold multiple board certificates, and this kind of activity can simultaneously meet requirements for licensure and several MOC programs.

Merging requirements

• reflective self-assessment
  
• assessment of knowledge and skills
  
• PIP.
  

Effects on reimbursement

In 2012, the Centers for Medicare and Medicaid Services’ Physician Quality Reporting System MOC Program Incentive provided a 0.5% incentive payment to physicians participating in a qualified MOC program.⁵ Other insurers are examining similar reimbursement incentives tied to practice assessment and improvement. Public reporting of quality metrics also is becoming more prevalent in practice and reimbursement incentives.

Related Resources

• Pinals DA. Ready or not, here it comes: maintenance of certification. J Am Acad Psychiatry Law. 2011;39(3):294-296.
  
• American Board of Psychiatry and Neurology, Inc. www.abpn.com.
  
• Maintenance of certification. American Board of Psychiatry and Neurology, Inc. www.abpn.com/moc_products.asp.
  
• NOW coalition performance improvement (PI) CME activity. NOW Coalition for Bipolar Disorder. www.nowbipolar.org/pi-cme.php.
  

Dr. Kues reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

In 2000, the American Board of Medical Specialties (ABMS) made a commitment to develop a maintenance of certification (MOC) system for their 24 specialty boards. MOC aims to keep physicians up to date because medical knowledge and practice are rapidly evolving and health care systems expect greater accountability linked with performance and outcomes. Previously, board certification for most specialties was limited to a 1-time board exam; upon passing, a clinician was considered board certified for life. The American Board of Psychiatry and Neurology (ABPN) first issued time-limited certificates for board certification in 1994; 2007 was the first year of initial MOC enrollment for ABPN. Diplomates whose certificates were issued before October 1, 1994 are not required to participate in the MOC program.

The ABPN time-limited certificates are on 10-year cycles and require diplomates to fulfill 4 MOC program components: Professional Standing, Self-Assessment and Continuing Medical Education (CME), Cognitive Expertise, and Performance in Practice (PIP) (Table).¹ Requirement details are available at www.abpn.com.

The ABMS MOC initiative is closely aligned with other initiatives, such as maintenance of licensure (MOL), that will impact all physicians, including those who are not board certified and those who were certified before October 1, 1994 and therefore not required to participate in MOC. Licensure, reimbursement, and institutional credentials are developing required measures based on self-assessment and performance.

Table

Maintenance of certification: 4 components

MOC requirements

The ABMS developed its MOC program around 6 general competencies identified by the Accreditation Council for Graduate Medical Education:

• professionalism
  
• patient care and procedural skills
  
• medical knowledge
  
• practice-based learning and improvement
  
• interpersonal and communications skills
  
• systems-based practice.
  

Physicians with “lifetime” certificates are not required to participate in MOC; there are no consequences for physicians who are not required to participate in MOC and choose not to participate, because MOC is a voluntary system. Physicians with time-limited certificates can choose not to participate, but would forfeit their certification. Physicians with certifications in multiple specialties may consider the value of maintaining all of their certifications because it would require them to participate in multiple MOC programs.

Two of the 4 parts of MOC (Parts I and III) are extensions of existing board certification requirements. Part I stipulates a diplomate hold a valid and unrestricted license in ≥1 states or jurisdictions in the United States, its territories, or Canada. Part III (Cognitive Expertise) requires that he or she must pass a cognitive examination every 10 years. To qualify to take the cognitive exam, a diplomate must meet all current MOC requirements.

Parts II and IV integrate continuing education, self-assessment, and the ability to apply both to practice improvements. Part II requires an average of 8 CME credit hours that include a self-assessment component; this likely would eliminate most traditional CME activities. The ABPN stipulates that feedback from the self-assessment must include a comparison with peers and specific literature recommendations for each question in the self-assessment. A small but growing number of accredited CME providers have developed self-directed CME activities that meet these criteria. As of 2014, only ABPN-approved self-assessment activities can be used to meet Part II requirements.

Part IV, the PIP activity, has raised the most concern. The PIP component focuses on quality improvement in 2 parts: a clinical module and a feedback module. This targets active clinicians, and both modules focus on quality improvement activities. The clinical module consists of a baseline chart review by the physician MOC applicant in which results are compared with best practices or practice guidelines. The practitioner-applicant repeats a second chart review after a period of time to determine if intervening practice improvements had a positive impact.

The feedback module consists of reviews of clinical performance by patients, peers, or other second parties such as other practice staff or administrators. These are repeated after a period of time to determine whether practice improvements have been effective.

The PIP model (assessment, practice improvement, reassessment) parallels requirements for Performance Improvement CME (PICME) activities. The American Medical Association (AMA) developed PICME at approximately the same time ABMS was creating MOC. PICME is aimed at changing physician behavior within the context of their clinical practice and is divided into 3 stages:

• Stage A: learning from current practice performance assessment
  
• Stage B: learning from the application of performance improvement to patient care
  
• Stage C: learning from the evaluation of the PICME effort.
  

For example, a coalition of academic, nonprofit, and business organizations—the NOW Coalition for Bipolar Disorder— developed an online quality improvement activity (see Related Resources), which the ABPN certified for assessment and PIP points. It also is certified for 20 points toward the Self-Evaluation of Practice Performance MOC requirement through the American Board of Internal Medicine’s Approved Quality Improvement Pathway, 20 AMA PRA Category 1 Credits™, and 20 Prescribed Credits by the AAFP. Many physicians hold multiple board certificates, and this kind of activity can simultaneously meet requirements for licensure and several MOC programs.

Merging requirements

• reflective self-assessment
  
• assessment of knowledge and skills
  
• PIP.
  

Effects on reimbursement

In 2012, the Centers for Medicare and Medicaid Services’ Physician Quality Reporting System MOC Program Incentive provided a 0.5% incentive payment to physicians participating in a qualified MOC program.⁵ Other insurers are examining similar reimbursement incentives tied to practice assessment and improvement. Public reporting of quality metrics also is becoming more prevalent in practice and reimbursement incentives.

Related Resources

• Pinals DA. Ready or not, here it comes: maintenance of certification. J Am Acad Psychiatry Law. 2011;39(3):294-296.
  
• American Board of Psychiatry and Neurology, Inc. www.abpn.com.
  
• Maintenance of certification. American Board of Psychiatry and Neurology, Inc. www.abpn.com/moc_products.asp.
  
• NOW coalition performance improvement (PI) CME activity. NOW Coalition for Bipolar Disorder. www.nowbipolar.org/pi-cme.php.
  

Dr. Kues reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

In 2000, the American Board of Medical Specialties (ABMS) made a commitment to develop a maintenance of certification (MOC) system for their 24 specialty boards. MOC aims to keep physicians up to date because medical knowledge and practice are rapidly evolving and health care systems expect greater accountability linked with performance and outcomes. Previously, board certification for most specialties was limited to a 1-time board exam; upon passing, a clinician was considered board certified for life. The American Board of Psychiatry and Neurology (ABPN) first issued time-limited certificates for board certification in 1994; 2007 was the first year of initial MOC enrollment for ABPN. Diplomates whose certificates were issued before October 1, 1994 are not required to participate in the MOC program.

The ABPN time-limited certificates are on 10-year cycles and require diplomates to fulfill 4 MOC program components: Professional Standing, Self-Assessment and Continuing Medical Education (CME), Cognitive Expertise, and Performance in Practice (PIP) (Table).¹ Requirement details are available at www.abpn.com.

The ABMS MOC initiative is closely aligned with other initiatives, such as maintenance of licensure (MOL), that will impact all physicians, including those who are not board certified and those who were certified before October 1, 1994 and therefore not required to participate in MOC. Licensure, reimbursement, and institutional credentials are developing required measures based on self-assessment and performance.

Table

Maintenance of certification: 4 components

MOC requirements

The ABMS developed its MOC program around 6 general competencies identified by the Accreditation Council for Graduate Medical Education:

• professionalism
  
• patient care and procedural skills
  
• medical knowledge
  
• practice-based learning and improvement
  
• interpersonal and communications skills
  
• systems-based practice.
  

Physicians with “lifetime” certificates are not required to participate in MOC; there are no consequences for physicians who are not required to participate in MOC and choose not to participate, because MOC is a voluntary system. Physicians with time-limited certificates can choose not to participate, but would forfeit their certification. Physicians with certifications in multiple specialties may consider the value of maintaining all of their certifications because it would require them to participate in multiple MOC programs.

Two of the 4 parts of MOC (Parts I and III) are extensions of existing board certification requirements. Part I stipulates a diplomate hold a valid and unrestricted license in ≥1 states or jurisdictions in the United States, its territories, or Canada. Part III (Cognitive Expertise) requires that he or she must pass a cognitive examination every 10 years. To qualify to take the cognitive exam, a diplomate must meet all current MOC requirements.

Parts II and IV integrate continuing education, self-assessment, and the ability to apply both to practice improvements. Part II requires an average of 8 CME credit hours that include a self-assessment component; this likely would eliminate most traditional CME activities. The ABPN stipulates that feedback from the self-assessment must include a comparison with peers and specific literature recommendations for each question in the self-assessment. A small but growing number of accredited CME providers have developed self-directed CME activities that meet these criteria. As of 2014, only ABPN-approved self-assessment activities can be used to meet Part II requirements.

Part IV, the PIP activity, has raised the most concern. The PIP component focuses on quality improvement in 2 parts: a clinical module and a feedback module. This targets active clinicians, and both modules focus on quality improvement activities. The clinical module consists of a baseline chart review by the physician MOC applicant in which results are compared with best practices or practice guidelines. The practitioner-applicant repeats a second chart review after a period of time to determine if intervening practice improvements had a positive impact.

The feedback module consists of reviews of clinical performance by patients, peers, or other second parties such as other practice staff or administrators. These are repeated after a period of time to determine whether practice improvements have been effective.

The PIP model (assessment, practice improvement, reassessment) parallels requirements for Performance Improvement CME (PICME) activities. The American Medical Association (AMA) developed PICME at approximately the same time ABMS was creating MOC. PICME is aimed at changing physician behavior within the context of their clinical practice and is divided into 3 stages:

• Stage A: learning from current practice performance assessment
  
• Stage B: learning from the application of performance improvement to patient care
  
• Stage C: learning from the evaluation of the PICME effort.
  

For example, a coalition of academic, nonprofit, and business organizations—the NOW Coalition for Bipolar Disorder— developed an online quality improvement activity (see Related Resources), which the ABPN certified for assessment and PIP points. It also is certified for 20 points toward the Self-Evaluation of Practice Performance MOC requirement through the American Board of Internal Medicine’s Approved Quality Improvement Pathway, 20 AMA PRA Category 1 Credits™, and 20 Prescribed Credits by the AAFP. Many physicians hold multiple board certificates, and this kind of activity can simultaneously meet requirements for licensure and several MOC programs.

Merging requirements

• reflective self-assessment
  
• assessment of knowledge and skills
  
• PIP.
  

Effects on reimbursement

In 2012, the Centers for Medicare and Medicaid Services’ Physician Quality Reporting System MOC Program Incentive provided a 0.5% incentive payment to physicians participating in a qualified MOC program.⁵ Other insurers are examining similar reimbursement incentives tied to practice assessment and improvement. Public reporting of quality metrics also is becoming more prevalent in practice and reimbursement incentives.

Related Resources

• Pinals DA. Ready or not, here it comes: maintenance of certification. J Am Acad Psychiatry Law. 2011;39(3):294-296.
  
• American Board of Psychiatry and Neurology, Inc. www.abpn.com.
  
• Maintenance of certification. American Board of Psychiatry and Neurology, Inc. www.abpn.com/moc_products.asp.
  
• NOW coalition performance improvement (PI) CME activity. NOW Coalition for Bipolar Disorder. www.nowbipolar.org/pi-cme.php.
  

Dr. Kues reports no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Discuss this article at www.facebook.com/CurrentPsychiatry

Recently there has been an increase in advertising soliciting participants for class-action lawsuits involving birth defects and antidepressants, particularly sertraline. Many psychiatrists are unsure why these ads are running in seemingly every medium because there has been no change in the FDA pregnancy classification for most selective serotonin reuptake inhibitors (SSRIs), except for paroxetine going from a C to a D rating in 2005.¹ Some studies have found SSRIs increase the risk of adverse birth outcomes and others have not, which makes it difficult for clinicians to know what to discuss with patients regarding the risks and benefits of using antidepressants during pregnancy, as well as the risks of untreated major depressive disorder (MDD).

It can be hard to encourage some patients to take necessary medications in the best of circumstances, let alone suggest that a pregnant woman take a medication that has been labeled “dangerous.” This article seeks to alleviate physicians’ fears about being caught in a no-win situation by:

• explaining factors that may have led to this increase in class-action lawsuits
  
• clarifying the risks of using certain medications and not treating depression
  
• suggesting ways physicians can protect themselves and their patients.
  

The FDA’s position

In July 2006, the FDA issued a public health advisory regarding SSRI use during pregnancy and the possibility of persistent pulmonary hypertension (PPHN).² This warning was based on a single study that found the risk of developing PPHN (baseline rate: 1 to 2 per 1,000 births) was 6 times greater for fetuses exposed to SSRIs in late pregnancy.³ Many legal websites highlight this 2006 warning as proof of SSRIs’ danger. However, because subsequent studies have had conflicting results, the FDA’s current position is that the risks of using SSRIs during pregnancy are “unknown” (Box).^1-4

Box

Risks of depression

Although most physicians know the risks of untreated MDD, they tend to minimize or forget these risks when a woman becomes pregnant. Pregnant women with MDD face not only the expected risks of their psychiatric illness but additionally face risks of pre-eclampsia, suicide (20% of deaths in the postpartum period are due to suicide), and infanticide.^5-10 Risks to the fetus include poor prenatal care, increased risk of intrauterine exposure to drugs or alcohol, increased exposure to maternal cortisol with resulting neurodevelopmental changes, preterm delivery, low birth weight, and failure to thrive.^6-8 Later difficulties for the child of a mother with untreated depression may include poor stress adaptation, decreased cognitive performance, and behavioral difficulties because of poor mother-child bonding and other factors.⁶

See Table 1 for key statistics regarding pregnancy and depression.

Table 1

Statistics on pregnancy and depression

Limitations of research

Because of ethical difficulties in studying MDD treatment during pregnancy, most data are retrospective and prone to detection and confounding biases, such as^11-15:

• the risks associated with depression
  
• comorbid conditions such as obesity
  
• maternal age
  
• poor prenatal care
  
• how the baby was delivered (eg, Caesarean sections have higher rates of PPHN)¹³
  
• illicit substance use
  
• effects of other medications (80% of pregnant women use medications, including nonsteroidal anti-inflammatory drugs [NSAIDs], which are associated with PPHN).^11,16
  

There are several potential adverse outcomes to consider when prescribing psychotropics to a pregnant woman, including miscarriage, malformation, preterm delivery, perinatal toxicity, and behavioral teratogenesis (Table 2).^6,7 SSRIs have been implicated in adverse outcomes, but there is no strong evidence that they increase the miscarriage rate, and several studies found no increase in birth defects.^6,13,18-20 Regarding teratogenesis, the FDA switched paroxetine from class C to class D because of a potential 1.5% to 2% risk of fetal cardiac malformation, compared with a 1% baseline rate in the general population.²¹ Drug toxicity or withdrawal in a neonate also is a risk; however, this condition is self-limited and managed supportively by neonatology.²² Behavioral teratogenesis—neurobehavioral problems that develop later in a child’s life—remains a hypothetical concern; research has been conflicting, and studies often used flawed methodology.

• these databases were not designed to answer these types of exposure questions (eg, limitations in data collected, such as other potential causes not recorded)
  
• they have many confounding biases (undocumented illicit substance use, possible minimization of smoking history, publication basis for positive findings, etc.)
  
• individuals who provided the data did not follow a standardized method (eg, variability among individual clinicians).
  

Not to case aspersions on this group’s work, it should be noted that this study had limitations, including that the researchers:

• did not take into account SSRI dosage
  
• did not measure depression severity or remittance
  
• were not able to fully account for potential exposures (eg, over-the-counter NSAIDs)
  
• were unable to confirm that patients took their medications because the variable measured was prescriptions filled
  
• did not interview participants about their medication use or symptoms.
  

In a more recent study,²⁴ 33 of 11,014 infants exposed to SSRIs after gestational week 20 developed PPHN (absolute risk: 3 per 1,000 births, compared with an incidence of 1.2 per 1,000 births in the general population), with an adjusted OR of 2.1 (95% CI 1.5 to 3.0). Although the authors warned that the results suggest a “class effect,” the rate of PPHN also was higher for mothers with a history of a psychiatric hospitalization within the last 10 years who were not taking medication (OR=1.3, 95% CI 1.0 to 1.6) and the OR for escitalopram (1.5, CI 0.2 to 10.5) was not statistically significant. This study did include a control group, but the 10-year window may have been too wide to represent a group with similar comorbid risks. Similar to the previously discussed study, mothers prescribed SSRIs were older, 1.7 times more likely to be smokers, and twice as likely to be prescribed NSAIDs. The study did not analyze the risk factors of smoking and body mass index because of an initial subset analysis (which was not reported) finding that these known risk factors for PPHN “did not confound the results.”²⁴

Table 2

Potential concerns when treating pregnant women with psychotropics

The basis of class-action lawsuits

Interest in class-action lawsuits involving birth defects and antidepressants, particularly sertraline, appears to be increasing. Many websites advertising these lawsuits quote unnamed articles from reputable medical journals to support the claim that the medications are dangerous and cause a wide range of birth defects. Although some of the birth defects mentioned are specific, others (eg, “breathing problems” or “gastrointestinal side effects”) are so broad that any problem or complication could conceivably be attributed to the antidepressant. The degree of causation—if any at all—for many of these conditions has not been determined. A national advertising campaign looking for any problem may be occurring because the exact risks are “unknown.”¹

The 2009 U.S. Supreme Court ruling in Wyeth v Levine²⁵ allows individuals to sue manufacturers of branded medications in state and federal court for lack of proper labeling. However, the 2011 U.S. Supreme Court case of PLIVA, Inc. v Mensing²⁶ prohibits state lawsuits against manufacturers of generic medications over labeling because by federal (superseding) law, generic manufacturers must use the same warnings as the branded medication. This may in part explain why many medications targeted in commercials and websites for class-action lawsuits are branded products, even though generics are available.

Protect your patient and yourself

An estimated 13% of pregnant women take antidepressants; SSRIs are the most commonly used antidepressant during and after pregnancy.⁹ Although not every depressed pregnant woman requires medication, those with moderate to severe depression often do. Rational medication decisions, informed consent, and good documentation are important when treating these women. Discuss the risks of untreated illness as well as the risks of medications to ensure that the patient understands that avoiding medication does not guarantee a safe pregnancy. Suggest psychotherapy and electroconvulsive therapy as options when appropriate. When possible, include the patient’s partner and family in the discussion to help improve compliance and potentially reduce strife.²⁹ The psychiatrist or patient should discuss the medication plan with the patient’s obstetrician or family physician.

Many women become pregnant while being treated for depression. Approximately one-half of all pregnancies are unplanned, so women using antidepressants may unknowingly expose their fetus to medication.³⁰ For this reason, it is important to discuss potential pregnancy and birth control concerns with all women of childbearing age before initiating pharmacotherapy.³¹ If an unintended pregnancy occurs, tell your patient to contact you before stopping any medications. Lawsuits also can occur because of wrongful death by suicide or infanticide because of lack of treatment; risk of untreated illness should not be treated lightly.

Related Resources

• Motherisk. www.motherisk.org.
  
• Organization of Teratology Information Specialists. www.otispregnancy.org.
  
• Massachusetts General Hospital Center for Women’s Mental Health. www.womensmentalhealth.org.
  

• Escitalopram • Lexapro
  
• Paroxetine • Paxil
  
• Sertraline • Zoloft
  

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Acknowledgments

The authors appreciate suggestions on prior versions of the manuscript from Miriam Rosenthal, Jaina Amin, Sarah Nagle-Yang, Sonal Moratschek, J.P. Shand, and Scott R. Miller.

Discuss this article at www.facebook.com/CurrentPsychiatry

Recently there has been an increase in advertising soliciting participants for class-action lawsuits involving birth defects and antidepressants, particularly sertraline. Many psychiatrists are unsure why these ads are running in seemingly every medium because there has been no change in the FDA pregnancy classification for most selective serotonin reuptake inhibitors (SSRIs), except for paroxetine going from a C to a D rating in 2005.¹ Some studies have found SSRIs increase the risk of adverse birth outcomes and others have not, which makes it difficult for clinicians to know what to discuss with patients regarding the risks and benefits of using antidepressants during pregnancy, as well as the risks of untreated major depressive disorder (MDD).

It can be hard to encourage some patients to take necessary medications in the best of circumstances, let alone suggest that a pregnant woman take a medication that has been labeled “dangerous.” This article seeks to alleviate physicians’ fears about being caught in a no-win situation by:

• explaining factors that may have led to this increase in class-action lawsuits
  
• clarifying the risks of using certain medications and not treating depression
  
• suggesting ways physicians can protect themselves and their patients.
  

The FDA’s position

In July 2006, the FDA issued a public health advisory regarding SSRI use during pregnancy and the possibility of persistent pulmonary hypertension (PPHN).² This warning was based on a single study that found the risk of developing PPHN (baseline rate: 1 to 2 per 1,000 births) was 6 times greater for fetuses exposed to SSRIs in late pregnancy.³ Many legal websites highlight this 2006 warning as proof of SSRIs’ danger. However, because subsequent studies have had conflicting results, the FDA’s current position is that the risks of using SSRIs during pregnancy are “unknown” (Box).^1-4

Box

Risks of depression

Although most physicians know the risks of untreated MDD, they tend to minimize or forget these risks when a woman becomes pregnant. Pregnant women with MDD face not only the expected risks of their psychiatric illness but additionally face risks of pre-eclampsia, suicide (20% of deaths in the postpartum period are due to suicide), and infanticide.^5-10 Risks to the fetus include poor prenatal care, increased risk of intrauterine exposure to drugs or alcohol, increased exposure to maternal cortisol with resulting neurodevelopmental changes, preterm delivery, low birth weight, and failure to thrive.^6-8 Later difficulties for the child of a mother with untreated depression may include poor stress adaptation, decreased cognitive performance, and behavioral difficulties because of poor mother-child bonding and other factors.⁶

See Table 1 for key statistics regarding pregnancy and depression.

Table 1

Statistics on pregnancy and depression

Limitations of research

Because of ethical difficulties in studying MDD treatment during pregnancy, most data are retrospective and prone to detection and confounding biases, such as^11-15:

• the risks associated with depression
  
• comorbid conditions such as obesity
  
• maternal age
  
• poor prenatal care
  
• how the baby was delivered (eg, Caesarean sections have higher rates of PPHN)¹³
  
• illicit substance use
  
• effects of other medications (80% of pregnant women use medications, including nonsteroidal anti-inflammatory drugs [NSAIDs], which are associated with PPHN).^11,16
  

There are several potential adverse outcomes to consider when prescribing psychotropics to a pregnant woman, including miscarriage, malformation, preterm delivery, perinatal toxicity, and behavioral teratogenesis (Table 2).^6,7 SSRIs have been implicated in adverse outcomes, but there is no strong evidence that they increase the miscarriage rate, and several studies found no increase in birth defects.^6,13,18-20 Regarding teratogenesis, the FDA switched paroxetine from class C to class D because of a potential 1.5% to 2% risk of fetal cardiac malformation, compared with a 1% baseline rate in the general population.²¹ Drug toxicity or withdrawal in a neonate also is a risk; however, this condition is self-limited and managed supportively by neonatology.²² Behavioral teratogenesis—neurobehavioral problems that develop later in a child’s life—remains a hypothetical concern; research has been conflicting, and studies often used flawed methodology.

• these databases were not designed to answer these types of exposure questions (eg, limitations in data collected, such as other potential causes not recorded)
  
• they have many confounding biases (undocumented illicit substance use, possible minimization of smoking history, publication basis for positive findings, etc.)
  
• individuals who provided the data did not follow a standardized method (eg, variability among individual clinicians).
  

Not to case aspersions on this group’s work, it should be noted that this study had limitations, including that the researchers:

• did not take into account SSRI dosage
  
• did not measure depression severity or remittance
  
• were not able to fully account for potential exposures (eg, over-the-counter NSAIDs)
  
• were unable to confirm that patients took their medications because the variable measured was prescriptions filled
  
• did not interview participants about their medication use or symptoms.
  

In a more recent study,²⁴ 33 of 11,014 infants exposed to SSRIs after gestational week 20 developed PPHN (absolute risk: 3 per 1,000 births, compared with an incidence of 1.2 per 1,000 births in the general population), with an adjusted OR of 2.1 (95% CI 1.5 to 3.0). Although the authors warned that the results suggest a “class effect,” the rate of PPHN also was higher for mothers with a history of a psychiatric hospitalization within the last 10 years who were not taking medication (OR=1.3, 95% CI 1.0 to 1.6) and the OR for escitalopram (1.5, CI 0.2 to 10.5) was not statistically significant. This study did include a control group, but the 10-year window may have been too wide to represent a group with similar comorbid risks. Similar to the previously discussed study, mothers prescribed SSRIs were older, 1.7 times more likely to be smokers, and twice as likely to be prescribed NSAIDs. The study did not analyze the risk factors of smoking and body mass index because of an initial subset analysis (which was not reported) finding that these known risk factors for PPHN “did not confound the results.”²⁴

Table 2

Potential concerns when treating pregnant women with psychotropics

The basis of class-action lawsuits

Interest in class-action lawsuits involving birth defects and antidepressants, particularly sertraline, appears to be increasing. Many websites advertising these lawsuits quote unnamed articles from reputable medical journals to support the claim that the medications are dangerous and cause a wide range of birth defects. Although some of the birth defects mentioned are specific, others (eg, “breathing problems” or “gastrointestinal side effects”) are so broad that any problem or complication could conceivably be attributed to the antidepressant. The degree of causation—if any at all—for many of these conditions has not been determined. A national advertising campaign looking for any problem may be occurring because the exact risks are “unknown.”¹

The 2009 U.S. Supreme Court ruling in Wyeth v Levine²⁵ allows individuals to sue manufacturers of branded medications in state and federal court for lack of proper labeling. However, the 2011 U.S. Supreme Court case of PLIVA, Inc. v Mensing²⁶ prohibits state lawsuits against manufacturers of generic medications over labeling because by federal (superseding) law, generic manufacturers must use the same warnings as the branded medication. This may in part explain why many medications targeted in commercials and websites for class-action lawsuits are branded products, even though generics are available.

Protect your patient and yourself

An estimated 13% of pregnant women take antidepressants; SSRIs are the most commonly used antidepressant during and after pregnancy.⁹ Although not every depressed pregnant woman requires medication, those with moderate to severe depression often do. Rational medication decisions, informed consent, and good documentation are important when treating these women. Discuss the risks of untreated illness as well as the risks of medications to ensure that the patient understands that avoiding medication does not guarantee a safe pregnancy. Suggest psychotherapy and electroconvulsive therapy as options when appropriate. When possible, include the patient’s partner and family in the discussion to help improve compliance and potentially reduce strife.²⁹ The psychiatrist or patient should discuss the medication plan with the patient’s obstetrician or family physician.

Many women become pregnant while being treated for depression. Approximately one-half of all pregnancies are unplanned, so women using antidepressants may unknowingly expose their fetus to medication.³⁰ For this reason, it is important to discuss potential pregnancy and birth control concerns with all women of childbearing age before initiating pharmacotherapy.³¹ If an unintended pregnancy occurs, tell your patient to contact you before stopping any medications. Lawsuits also can occur because of wrongful death by suicide or infanticide because of lack of treatment; risk of untreated illness should not be treated lightly.

Related Resources

• Motherisk. www.motherisk.org.
  
• Organization of Teratology Information Specialists. www.otispregnancy.org.
  
• Massachusetts General Hospital Center for Women’s Mental Health. www.womensmentalhealth.org.
  

• Escitalopram • Lexapro
  
• Paroxetine • Paxil
  
• Sertraline • Zoloft
  

The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Acknowledgments

The authors appreciate suggestions on prior versions of the manuscript from Miriam Rosenthal, Jaina Amin, Sarah Nagle-Yang, Sonal Moratschek, J.P. Shand, and Scott R. Miller.

Discuss this article at www.facebook.com/CurrentPsychiatry

Recently there has been an increase in advertising soliciting participants for class-action lawsuits involving birth defects and antidepressants, particularly sertraline. Many psychiatrists are unsure why these ads are running in seemingly every medium because there has been no change in the FDA pregnancy classification for most selective serotonin reuptake inhibitors (SSRIs), except for paroxetine going from a C to a D rating in 2005.¹ Some studies have found SSRIs increase the risk of adverse birth outcomes and others have not, which makes it difficult for clinicians to know what to discuss with patients regarding the risks and benefits of using antidepressants during pregnancy, as well as the risks of untreated major depressive disorder (MDD).

It can be hard to encourage some patients to take necessary medications in the best of circumstances, let alone suggest that a pregnant woman take a medication that has been labeled “dangerous.” This article seeks to alleviate physicians’ fears about being caught in a no-win situation by:

• explaining factors that may have led to this increase in class-action lawsuits
  
• clarifying the risks of using certain medications and not treating depression
  
• suggesting ways physicians can protect themselves and their patients.
  

The FDA’s position

In July 2006, the FDA issued a public health advisory regarding SSRI use during pregnancy and the possibility of persistent pulmonary hypertension (PPHN).² This warning was based on a single study that found the risk of developing PPHN (baseline rate: 1 to 2 per 1,000 births) was 6 times greater for fetuses exposed to SSRIs in late pregnancy.³ Many legal websites highlight this 2006 warning as proof of SSRIs’ danger. However, because subsequent studies have had conflicting results, the FDA’s current position is that the risks of using SSRIs during pregnancy are “unknown” (Box).^1-4

Box

Risks of depression

Although most physicians know the risks of untreated MDD, they tend to minimize or forget these risks when a woman becomes pregnant. Pregnant women with MDD face not only the expected risks of their psychiatric illness but additionally face risks of pre-eclampsia, suicide (20% of deaths in the postpartum period are due to suicide), and infanticide.^5-10 Risks to the fetus include poor prenatal care, increased risk of intrauterine exposure to drugs or alcohol, increased exposure to maternal cortisol with resulting neurodevelopmental changes, preterm delivery, low birth weight, and failure to thrive.^6-8 Later difficulties for the child of a mother with untreated depression may include poor stress adaptation, decreased cognitive performance, and behavioral difficulties because of poor mother-child bonding and other factors.⁶

See Table 1 for key statistics regarding pregnancy and depression.

Table 1

Statistics on pregnancy and depression