Modern medicine … certainly as it should be practiced by hospitalists, is the most information-intensive activity that human beings ever engaged in,” says Kenneth W. Kizer, MD, MPH, CEO and chairman of the board of Medsphere Systems Corporation in Aliso Viejo, Calif.

He should know. From his first healthcare-related position in 1969 as a hospital orderly at Stanford University Hospital, he rose to become the Under Secretary for Health in the Department of Veterans Affairs (VA)—the CEO of the largest healthcare system in the nation. He is widely credited as being the chief architect and driving force behind the successful transformation of VA healthcare in the 1990s.

The VA’s 154 hospitals and 875 clinics, which serve 5.4 million patients, have been rated “best in class” by a number of independent groups since it implemented the changes in the 1990s.1 In a study conducted by the Rand Corporation, the VA scored higher compared with the U.S. private sector hospitals in every category except acute care, in which “the numbers ran neck and neck,” says Dr. Kizer. “Where the VA has done much better [than private sector hospitals] is in managing chronic disease and integrating prevention and health maintenance into the acute care program.”

Differences between a VA facility and one in the private sector are mostly “cosmetic and in the financing,” says Dr. Kizer. “The VA takes care of a particular patient population—veterans of military service—but it is a civilian practice that happens to be run by the federal government.”

According to a July 17, 2006, article in BusinessWeek, “The Best Medical Care in the U.S.,” the VA system provides about two-thirds of the care protocols recommended by organizations such as the Agency for Healthcare Research and Quality, compared with 50% provided in private sector hospitals.1 Also, as many as 8% of the prescriptions filled in private sector hospitals contain errors, but the VA’s prescription-related accuracy is greater than 99.997%. In addition, the VA spends an average of $5,000 per patient compared with the national average of $6,300.

Dr. Kizer’s focus on quality improvement at the VA should not be surprising in view of his long-time focus on improving the quality of healthcare. In his mind, an essential element in improving the quality of American healthcare is the widespread adoption of electronic health records (EHR).

When he arrived at his post at the VA in 1994, Dr. Kizer was pleasantly surprised to find advanced automated information management in place. The VA had been working on developing an EHR since 1978. As part Kizer’s transformation of the VA, all of the VA’s information systems were integrated, and VistA (an acronym for Veterans Health Information Systems and Technology Architecture) was launched in 1997. VistA is often the first thing that VA-affiliated hospitalists mention when they are asked what distinguishes VA hospitals from non-VA hospitals.

Key Features and Benefits of the VA

Sanjay Saint, MD, knows a great deal about academically affiliated VAs. He was a resident (July 1993-June 1995) and then chief medical resident at the San Francisco VA (June 1995-June 1996), an affiliate of the University of California at San Francisco. He was also a fellow at the University of Washington-affiliated Seattle VA (July 1996-June 1998), and for more than eight years he has been on the faculty at the University of Michigan as a professor of internal medicine (1998-2006). Dr. Saint is currently a hospitalist at the University of Michigan-affiliated Ann Arbor VA Hospital. He was also recently the acting chief of medicine there for six months (Dec. 2005-May 2006) while the permanent chief was on sabbatical.

The instant availability of the EHR system is a key benefit of practicing in a VA hospital, says Dr. Saint. “It involves not only being able to get up-to-date, relevant patient information at our VA but also the information obtained if the patient has been seen at other VAs.”

“One of the reasons why [the VA’s EHR] is so good is that it is fully integrated,” says Dr. Kizer. “Everything was made to fit together to begin with—in contrast to essentially all commercial products, which have been melded together from pieces that come from a variety of origins. Being fully integrated certainly increases the speed and efficiency of operations. The second reason why VistA is so good is that it was developed by clinicians for clinicians … .”

A key feature operating as part of the EHR is the focus on computer-based provider order entry (CPOE). CPOE can help physicians make correct clinical decisions, says Dr. Saint. He cites the example of a pilot test he and co-workers conducted at the Seattle VA: After 72 hours of urinary catheterization in a patient, an alert reminded physicians to remove the catheter. From that simple type of quality improvement experiment, the data revealed that those patients for whom the reminder had been used had a significantly reduced rate of infection compared with those for whom it had not.

One particularly good, but perhaps underutilized, aspect of the computerized system is the use of care protocols or models that can be used across the VA, says Peter Kaboli, MD, MS, hospitalist at the Iowa City VA Hospital, an affiliate of the University of Iowa. “And we could probably … have more available electronically [that] could be modified for the local care environment,” he says, adding that insulin protocols come to mind first.

Another key EHR feature is an extensive adverse event reporting system, including registering near misses. About 96% of prescriptions and physician orders are entered with the system; in private sector hospitals, the rough estimate is 8%. There is also a bar-coding system for verification of medications and identification of patients. The VA “has done a great job of changing the culture to foster systems-based care and to address errors and adverse patient outcomes straightforward[ly] and deal with them up front.”

Another distinguishing feature of the VA, says Dr. Saint, is its heavy investment in quality improvement and health services research (HSR). The VA has large repositories of administrative and clinical data for performing research with hospitalized patients. Dr. Saint also points out that a lot of the academic centers benefit from having a VA as an affiliate. “The house staff, medical students, and physicians often will be at the VA [and can] see the state-of-the-art electronic medical records and CPOE system and inquire, ‘Why can’t we have that at the university hospital?’ ”

Discharge: Seamless Transition

Dr. Kaboli can point to another advantage for hospital medicine in the VA: a concerted interest in developing hospitalists. Two-thirds of VA medical centers (VAMCs) use hospitalists, and two-thirds of inpatients are cared for by hospitalists. In total, approximately 400 hospitalists are employed by the VA, making it the largest single employer of hospitalists in the United States. Within two years, 75% of VAMCs will use hospitalists.2

Dr. Kaboli has also become well versed on the advantages of the VA’s EHR in the area of patient discharge. The greatest benefit to hospitalists of having a fully integrated medical record with CPOE and all inpatient and outpatient notes available in all the VA facilities across the country, he says, “is the almost seamless transition of these records both from the clinic side to the hospital and from the hospital back to the clinic.”

One “great luxury” of having that integrated system, Dr. Kaboli adds, is that a hospitalist can hand patients their discharge summaries and advise them to pass the information on in the next doctor’s visit. “Even though you’re going to send it via e-mail, [in a] fax, or by mail, you have that as another option to translate that information to other docs,” he explains. Hospitalists can also “alert other providers by making them co-signers to notes so that when it comes into their inbox, they know that a patient was discharged, and they get the discharge summary immediately.”

There is no connection electronically with non-VA providers, however, which is the same situation that exists in any other non-VA healthcare system. “We know [that] a fairly large percentage of veterans receive care, both within and outside the VA, who are what we call co-managed,” says Dr. Kaboli. “If a patient doesn’t live near a VA hospital or clinic, he may have to travel an hour or two, so that person might as well have a local doctor. Without that [EHR system], if [the patient is] speaking to a primary care physician in a local community, [that physician is] up against the same challenges as [someone who works] outside the VA.”

Get on the EHR Bandwagon

“The federal government has a crucial leadership role in promoting a national health information infrastructure,” said Dr. Kizer in his June 17, 2004 testimony to Congress. When asked about that statement, Dr. Saint (who is also director of the VA/University of Michigan Patient Safety Enhancement Program) has one piece of advice for his hospitalist colleagues. “You don’t want perfect to become the enemy of the very good,” he says. “Rather than waiting until there is a national technology information infrastructure, which may be years—if not decades—away, you can at least advocate for change in your own hospital.”

Use the VA as a model, he says. “You don’t have to use the exact same system, but at least you can point to some of the quality advantages that electronic medical records and CPOE can provide. You can also point out some of the advantages that investment in quality improvement and health services research can bring to an organization and say, ‘We can adapt—not necessarily adopt—what the VA has done.’ ”

How can hospitalists best do that? Many publications in the peer-reviewed literature address the quality improvement focus of the VA. There is also a VA Web site that discusses the focus on HSR and development (www1. va.gov/health). A VA-sponsored national health services research and development (HSR&D) meeting, at which investigators from all over the country present their latest findings, is held annually in Washington, D.C., usually in February.

For the young hospitalist who wants to pursue additional training, Dr. Saint says, there are VA-funded fellowships, HSR&D, a quality scholars program, and other career development opportunities within the VA that promote leadership roles both in and outside the VA.

Dr. Kaboli suggests identifying networks of hospitalists within and outside of your own healthcare system that you can work with and learn from. Hospitalists can also collaborate in developing protocols that incorporate local modifications. Also, he suggests, “there are a lot of questions that come up in the day-to-day care of patients. If you have colleagues as interested as you are, as hospitalists, in the quality of care for hospitalized medical patients, you can tap into that passion. The SHM listservs are a great way to connect; one for VA hospitalists has just been organized.

Anyone interested in the OpenVista Electronic Health Record, Medsphere’s commercial product (which, Dr. Kizer says, “is VistA at the core” and is being marketed to hospitals and large clinics) can learn more at www.medsphere.com.

Dr. Kizer says hospitalists will need to understand the needs of future healthcare and help prepare for and welcome it. “For example, performance measurement is an absolute part of the future of healthcare,” he says. “I think, by and large, hospitalists understand that better and are more accepting of that than certainly most docs in private practice.”

He believes hospitalists “can help promote that understanding among their peers and their hospitals and keep moving things forward as opposed to resisting it.” This is just one aspect of the “openness and transparency that we want to see in so many areas,” says Dr. Kizer, and hospitalists can be “pushing for the tools to make it happen. The hospitalists, I would think, should be leading the charge for electronic health records.”

Now and Tomorrow

Dr. Kizer, who is one of nine experts on veterans’ issues named to the newly formed Commission on the Future for America’s Veterans and is board certified in six medical specialties, also has a personal view on the work of hospital medicine. Recently, his wife was hospitalized in the ICU at the University of California at Davis Medical Center for a number of months, and Dr. Kizer says that a succession of hospitalists have served as her principal providers. It’s given him a more intimate view of what matters, beyond strictly clinical care, to patients and their families.

“By and large, I’ve always supported the hospitalist notion,” he says, “because it … supports my view [that] keeping up to date on all the science and technology and running an office practice [at the same time] is just more than you can reasonably expect anyone to do.” What he has especially noticed now, as a family caregiver visiting a hospital, “is that there is tremendous variability in how much [hospitalists] communicate with the patient and his or her family and how they view the episode of care within the context of the family and their community.”

Dr. Kizer, who has studied communications for a long time and in myriad ways, notes that a lot of the hospitalists he has met during this recent experience “think they’re communicating, but they often don’t take the time to determine if they are actually connecting with the family or addressing the issues that are important to the patient and family.”

In the same vein, he agrees that the better the electronic communication systems of a healthcare system—including proficiency in identifying medical errors—the more minutes can be freed up for a physician to pull up a chair and talk with a patient. “It is also a powerful tool to educate and to help inform,” he says. “For example, when [a hospitalist] can just quickly graph out where the patient’s blood pressure … or blood sugars or … creatinine has been, you can use the display of data to quickly educate the patient and/or the family about what has happened and where you need to go. One picture can save you 10 minutes of explaining.”

Conclusion

The VA has taken a lead in addressing the issues that have been brought up over the years by organizations such as the Institute of Medicine and the Institute for Healthcare Improvement. Their integrated electronic health records system can serve as a model for non-VA hospitals. Until there is a national integration of computerized technology, hospitalists can become advocates for improving their own hospital technology systems. “Electronic health records and hospitalists should go hand in glove,” concludes Dr. Kizer. “It’s potentially a great marriage of technology and the human element.” TH

Andrea Sattinger is a regular contributor to The Hospitalist.

References

1. Arnst C. The best medical care in the U.S.: How Veterans Affairs transformed itself—and what it means for the rest of us. BusinessWeek online. July 17, 2006. Available at www.businessweek.com/magazine/content/06_29/b3993061.htm?chan=top+news_top+news. Last accessed October 20, 2006.
2. Kaboli PJ, Barrett T, Vazirani S, et al. Growth of hospitalists in the Veterans Administration (VA) healthcare system: 1997-2005. Hosp Med. Abstract. 2006;1(S2):1-30.
3. Lurie JD, Merrens EJ, Lee J, et al. An approach to hospital quality improvement. Med Clin North Am. 2002 Jul;86(4):825-845.

A Hospitalist Revolutionizes UCSD’s Online Clinical Systems

Josh Lee, MD, is a hospitalist. But Dr. Lee is also a computer geek, and the combination has served him and patient care well.

As medical director of Information Services at the University of California at San Diego (UCSD), Dr. Lee has oversight over all online clinical systems, and that is no small task. With Dr. Lee’s guidance, UCSD is now a leader in the medical informatics movement. With the exception of physician documentation, the system has comprehensive electronic records; that is, some physicians still prefer to “wet-sign” their notes. Lab results at UCSD are 100% electronic, as is order entry for adult inpatients. “We have now completed what we call the entire order life cycle: physician orders, direct integrations through our pharmacy, pharmacy validation, and bar-coded administration at bedside,” he says.

As opposed to the VA’s homegrown EHR, UCSD did what many healthcare systems do: They bought an off-the-shelf product—this one was Invision from Siemens—but UCSD calls their product PCIS, for Patient Care Information Services.

“A lot of people are able to do cool stuff [with medical informatics],” says Dr. Lee, “but they have done it with a proprietary product, so it’s different than VA, where they are using something they have total control over.”

He says many people are now focused on order entry, “but I think the newest area of research and integration [involves the question], how do we communicate key clinical issues and follow-up for discharge?” (See Figure 1, above.) At UCSD Medical Center, these screens can be printed and the pages given directly to the patient upon discharge.) “We have leveraged our electronic system to ensure that, at the moment of discharge, not only is the patient informed about [his or her] care, but it is clear to anybody on our side, or from the side of the receiving physician, what is supposed to happen next.”

As any hospitalist knows, there can be a huge “voltage drop” in this area, as Robert Wachter, MD, professor and associate chairman at UCSF’s Department of Medicine, San Francisco, refers to it. Dr. Wachter is

And the great advantages of the VA’s electronic products are not available to the “99% of American hospitalists who don’t practice in closed systems,” says Dr. Lee.

Because most hospitalists don’t have that advantage, careful and complete discharge communications are imperative. That’s why UCSD built screens that can accommodate the specific information patients need, he says. “It’s different from the classic discharge summary, which is usually a lengthy, unwieldy, dictated document that is mostly [composed] after the patient leaves the hospital. This is done in real time … and these print-outs are immediately available for the patient.”

Before Dr. Lee came to UCSD, he worked with Drs. Jon Lurie, Mark Splaine, and Ed Merrens, all members of the general internal medicine division at Dartmouth-Hitchcock Medical Center in Hanover, N.H.3 As part of the team’s exploration of quality improvement and medical informatics, they particularly looked at how to adapt products to be workflow sensitive.

And one of the most important things Dr. Lee says he would tell his counterparts at other institutions is “to ensure that computerized solutions for safety and documentation are appropriately matched to the work flow.” He thinks that when these initiatives fail it is often due to an underappreciation of the impact that these changes and enhancements have on actual provision of care. “Do those things that are [the] most highly successful, leverage moments that you’re going to do anyway, but then automate it, make it safer, make it more comprehensive,” he says. “That’s my challenge to my colleagues.”—AS

Modern medicine … certainly as it should be practiced by hospitalists, is the most information-intensive activity that human beings ever engaged in,” says Kenneth W. Kizer, MD, MPH, CEO and chairman of the board of Medsphere Systems Corporation in Aliso Viejo, Calif.

He should know. From his first healthcare-related position in 1969 as a hospital orderly at Stanford University Hospital, he rose to become the Under Secretary for Health in the Department of Veterans Affairs (VA)—the CEO of the largest healthcare system in the nation. He is widely credited as being the chief architect and driving force behind the successful transformation of VA healthcare in the 1990s.

The VA’s 154 hospitals and 875 clinics, which serve 5.4 million patients, have been rated “best in class” by a number of independent groups since it implemented the changes in the 1990s.1 In a study conducted by the Rand Corporation, the VA scored higher compared with the U.S. private sector hospitals in every category except acute care, in which “the numbers ran neck and neck,” says Dr. Kizer. “Where the VA has done much better [than private sector hospitals] is in managing chronic disease and integrating prevention and health maintenance into the acute care program.”

Differences between a VA facility and one in the private sector are mostly “cosmetic and in the financing,” says Dr. Kizer. “The VA takes care of a particular patient population—veterans of military service—but it is a civilian practice that happens to be run by the federal government.”

According to a July 17, 2006, article in BusinessWeek, “The Best Medical Care in the U.S.,” the VA system provides about two-thirds of the care protocols recommended by organizations such as the Agency for Healthcare Research and Quality, compared with 50% provided in private sector hospitals.1 Also, as many as 8% of the prescriptions filled in private sector hospitals contain errors, but the VA’s prescription-related accuracy is greater than 99.997%. In addition, the VA spends an average of $5,000 per patient compared with the national average of $6,300.

Dr. Kizer’s focus on quality improvement at the VA should not be surprising in view of his long-time focus on improving the quality of healthcare. In his mind, an essential element in improving the quality of American healthcare is the widespread adoption of electronic health records (EHR).

When he arrived at his post at the VA in 1994, Dr. Kizer was pleasantly surprised to find advanced automated information management in place. The VA had been working on developing an EHR since 1978. As part Kizer’s transformation of the VA, all of the VA’s information systems were integrated, and VistA (an acronym for Veterans Health Information Systems and Technology Architecture) was launched in 1997. VistA is often the first thing that VA-affiliated hospitalists mention when they are asked what distinguishes VA hospitals from non-VA hospitals.

Key Features and Benefits of the VA

Sanjay Saint, MD, knows a great deal about academically affiliated VAs. He was a resident (July 1993-June 1995) and then chief medical resident at the San Francisco VA (June 1995-June 1996), an affiliate of the University of California at San Francisco. He was also a fellow at the University of Washington-affiliated Seattle VA (July 1996-June 1998), and for more than eight years he has been on the faculty at the University of Michigan as a professor of internal medicine (1998-2006). Dr. Saint is currently a hospitalist at the University of Michigan-affiliated Ann Arbor VA Hospital. He was also recently the acting chief of medicine there for six months (Dec. 2005-May 2006) while the permanent chief was on sabbatical.

The instant availability of the EHR system is a key benefit of practicing in a VA hospital, says Dr. Saint. “It involves not only being able to get up-to-date, relevant patient information at our VA but also the information obtained if the patient has been seen at other VAs.”

“One of the reasons why [the VA’s EHR] is so good is that it is fully integrated,” says Dr. Kizer. “Everything was made to fit together to begin with—in contrast to essentially all commercial products, which have been melded together from pieces that come from a variety of origins. Being fully integrated certainly increases the speed and efficiency of operations. The second reason why VistA is so good is that it was developed by clinicians for clinicians … .”

A key feature operating as part of the EHR is the focus on computer-based provider order entry (CPOE). CPOE can help physicians make correct clinical decisions, says Dr. Saint. He cites the example of a pilot test he and co-workers conducted at the Seattle VA: After 72 hours of urinary catheterization in a patient, an alert reminded physicians to remove the catheter. From that simple type of quality improvement experiment, the data revealed that those patients for whom the reminder had been used had a significantly reduced rate of infection compared with those for whom it had not.

One particularly good, but perhaps underutilized, aspect of the computerized system is the use of care protocols or models that can be used across the VA, says Peter Kaboli, MD, MS, hospitalist at the Iowa City VA Hospital, an affiliate of the University of Iowa. “And we could probably … have more available electronically [that] could be modified for the local care environment,” he says, adding that insulin protocols come to mind first.

Another key EHR feature is an extensive adverse event reporting system, including registering near misses. About 96% of prescriptions and physician orders are entered with the system; in private sector hospitals, the rough estimate is 8%. There is also a bar-coding system for verification of medications and identification of patients. The VA “has done a great job of changing the culture to foster systems-based care and to address errors and adverse patient outcomes straightforward[ly] and deal with them up front.”

Another distinguishing feature of the VA, says Dr. Saint, is its heavy investment in quality improvement and health services research (HSR). The VA has large repositories of administrative and clinical data for performing research with hospitalized patients. Dr. Saint also points out that a lot of the academic centers benefit from having a VA as an affiliate. “The house staff, medical students, and physicians often will be at the VA [and can] see the state-of-the-art electronic medical records and CPOE system and inquire, ‘Why can’t we have that at the university hospital?’ ”

Discharge: Seamless Transition

Dr. Kaboli can point to another advantage for hospital medicine in the VA: a concerted interest in developing hospitalists. Two-thirds of VA medical centers (VAMCs) use hospitalists, and two-thirds of inpatients are cared for by hospitalists. In total, approximately 400 hospitalists are employed by the VA, making it the largest single employer of hospitalists in the United States. Within two years, 75% of VAMCs will use hospitalists.2

Dr. Kaboli has also become well versed on the advantages of the VA’s EHR in the area of patient discharge. The greatest benefit to hospitalists of having a fully integrated medical record with CPOE and all inpatient and outpatient notes available in all the VA facilities across the country, he says, “is the almost seamless transition of these records both from the clinic side to the hospital and from the hospital back to the clinic.”

One “great luxury” of having that integrated system, Dr. Kaboli adds, is that a hospitalist can hand patients their discharge summaries and advise them to pass the information on in the next doctor’s visit. “Even though you’re going to send it via e-mail, [in a] fax, or by mail, you have that as another option to translate that information to other docs,” he explains. Hospitalists can also “alert other providers by making them co-signers to notes so that when it comes into their inbox, they know that a patient was discharged, and they get the discharge summary immediately.”

There is no connection electronically with non-VA providers, however, which is the same situation that exists in any other non-VA healthcare system. “We know [that] a fairly large percentage of veterans receive care, both within and outside the VA, who are what we call co-managed,” says Dr. Kaboli. “If a patient doesn’t live near a VA hospital or clinic, he may have to travel an hour or two, so that person might as well have a local doctor. Without that [EHR system], if [the patient is] speaking to a primary care physician in a local community, [that physician is] up against the same challenges as [someone who works] outside the VA.”

Get on the EHR Bandwagon

“The federal government has a crucial leadership role in promoting a national health information infrastructure,” said Dr. Kizer in his June 17, 2004 testimony to Congress. When asked about that statement, Dr. Saint (who is also director of the VA/University of Michigan Patient Safety Enhancement Program) has one piece of advice for his hospitalist colleagues. “You don’t want perfect to become the enemy of the very good,” he says. “Rather than waiting until there is a national technology information infrastructure, which may be years—if not decades—away, you can at least advocate for change in your own hospital.”

Use the VA as a model, he says. “You don’t have to use the exact same system, but at least you can point to some of the quality advantages that electronic medical records and CPOE can provide. You can also point out some of the advantages that investment in quality improvement and health services research can bring to an organization and say, ‘We can adapt—not necessarily adopt—what the VA has done.’ ”

How can hospitalists best do that? Many publications in the peer-reviewed literature address the quality improvement focus of the VA. There is also a VA Web site that discusses the focus on HSR and development (www1. va.gov/health). A VA-sponsored national health services research and development (HSR&D) meeting, at which investigators from all over the country present their latest findings, is held annually in Washington, D.C., usually in February.

For the young hospitalist who wants to pursue additional training, Dr. Saint says, there are VA-funded fellowships, HSR&D, a quality scholars program, and other career development opportunities within the VA that promote leadership roles both in and outside the VA.

Dr. Kaboli suggests identifying networks of hospitalists within and outside of your own healthcare system that you can work with and learn from. Hospitalists can also collaborate in developing protocols that incorporate local modifications. Also, he suggests, “there are a lot of questions that come up in the day-to-day care of patients. If you have colleagues as interested as you are, as hospitalists, in the quality of care for hospitalized medical patients, you can tap into that passion. The SHM listservs are a great way to connect; one for VA hospitalists has just been organized.

Anyone interested in the OpenVista Electronic Health Record, Medsphere’s commercial product (which, Dr. Kizer says, “is VistA at the core” and is being marketed to hospitals and large clinics) can learn more at www.medsphere.com.

Dr. Kizer says hospitalists will need to understand the needs of future healthcare and help prepare for and welcome it. “For example, performance measurement is an absolute part of the future of healthcare,” he says. “I think, by and large, hospitalists understand that better and are more accepting of that than certainly most docs in private practice.”

He believes hospitalists “can help promote that understanding among their peers and their hospitals and keep moving things forward as opposed to resisting it.” This is just one aspect of the “openness and transparency that we want to see in so many areas,” says Dr. Kizer, and hospitalists can be “pushing for the tools to make it happen. The hospitalists, I would think, should be leading the charge for electronic health records.”

Now and Tomorrow

Dr. Kizer, who is one of nine experts on veterans’ issues named to the newly formed Commission on the Future for America’s Veterans and is board certified in six medical specialties, also has a personal view on the work of hospital medicine. Recently, his wife was hospitalized in the ICU at the University of California at Davis Medical Center for a number of months, and Dr. Kizer says that a succession of hospitalists have served as her principal providers. It’s given him a more intimate view of what matters, beyond strictly clinical care, to patients and their families.

“By and large, I’ve always supported the hospitalist notion,” he says, “because it … supports my view [that] keeping up to date on all the science and technology and running an office practice [at the same time] is just more than you can reasonably expect anyone to do.” What he has especially noticed now, as a family caregiver visiting a hospital, “is that there is tremendous variability in how much [hospitalists] communicate with the patient and his or her family and how they view the episode of care within the context of the family and their community.”

Dr. Kizer, who has studied communications for a long time and in myriad ways, notes that a lot of the hospitalists he has met during this recent experience “think they’re communicating, but they often don’t take the time to determine if they are actually connecting with the family or addressing the issues that are important to the patient and family.”

In the same vein, he agrees that the better the electronic communication systems of a healthcare system—including proficiency in identifying medical errors—the more minutes can be freed up for a physician to pull up a chair and talk with a patient. “It is also a powerful tool to educate and to help inform,” he says. “For example, when [a hospitalist] can just quickly graph out where the patient’s blood pressure … or blood sugars or … creatinine has been, you can use the display of data to quickly educate the patient and/or the family about what has happened and where you need to go. One picture can save you 10 minutes of explaining.”

Conclusion

The VA has taken a lead in addressing the issues that have been brought up over the years by organizations such as the Institute of Medicine and the Institute for Healthcare Improvement. Their integrated electronic health records system can serve as a model for non-VA hospitals. Until there is a national integration of computerized technology, hospitalists can become advocates for improving their own hospital technology systems. “Electronic health records and hospitalists should go hand in glove,” concludes Dr. Kizer. “It’s potentially a great marriage of technology and the human element.” TH

Andrea Sattinger is a regular contributor to The Hospitalist.

References

1. Arnst C. The best medical care in the U.S.: How Veterans Affairs transformed itself—and what it means for the rest of us. BusinessWeek online. July 17, 2006. Available at www.businessweek.com/magazine/content/06_29/b3993061.htm?chan=top+news_top+news. Last accessed October 20, 2006.
2. Kaboli PJ, Barrett T, Vazirani S, et al. Growth of hospitalists in the Veterans Administration (VA) healthcare system: 1997-2005. Hosp Med. Abstract. 2006;1(S2):1-30.
3. Lurie JD, Merrens EJ, Lee J, et al. An approach to hospital quality improvement. Med Clin North Am. 2002 Jul;86(4):825-845.

A Hospitalist Revolutionizes UCSD’s Online Clinical Systems

Josh Lee, MD, is a hospitalist. But Dr. Lee is also a computer geek, and the combination has served him and patient care well.

As medical director of Information Services at the University of California at San Diego (UCSD), Dr. Lee has oversight over all online clinical systems, and that is no small task. With Dr. Lee’s guidance, UCSD is now a leader in the medical informatics movement. With the exception of physician documentation, the system has comprehensive electronic records; that is, some physicians still prefer to “wet-sign” their notes. Lab results at UCSD are 100% electronic, as is order entry for adult inpatients. “We have now completed what we call the entire order life cycle: physician orders, direct integrations through our pharmacy, pharmacy validation, and bar-coded administration at bedside,” he says.

As opposed to the VA’s homegrown EHR, UCSD did what many healthcare systems do: They bought an off-the-shelf product—this one was Invision from Siemens—but UCSD calls their product PCIS, for Patient Care Information Services.

“A lot of people are able to do cool stuff [with medical informatics],” says Dr. Lee, “but they have done it with a proprietary product, so it’s different than VA, where they are using something they have total control over.”

He says many people are now focused on order entry, “but I think the newest area of research and integration [involves the question], how do we communicate key clinical issues and follow-up for discharge?” (See Figure 1, above.) At UCSD Medical Center, these screens can be printed and the pages given directly to the patient upon discharge.) “We have leveraged our electronic system to ensure that, at the moment of discharge, not only is the patient informed about [his or her] care, but it is clear to anybody on our side, or from the side of the receiving physician, what is supposed to happen next.”

As any hospitalist knows, there can be a huge “voltage drop” in this area, as Robert Wachter, MD, professor and associate chairman at UCSF’s Department of Medicine, San Francisco, refers to it. Dr. Wachter is

And the great advantages of the VA’s electronic products are not available to the “99% of American hospitalists who don’t practice in closed systems,” says Dr. Lee.

Because most hospitalists don’t have that advantage, careful and complete discharge communications are imperative. That’s why UCSD built screens that can accommodate the specific information patients need, he says. “It’s different from the classic discharge summary, which is usually a lengthy, unwieldy, dictated document that is mostly [composed] after the patient leaves the hospital. This is done in real time … and these print-outs are immediately available for the patient.”

Before Dr. Lee came to UCSD, he worked with Drs. Jon Lurie, Mark Splaine, and Ed Merrens, all members of the general internal medicine division at Dartmouth-Hitchcock Medical Center in Hanover, N.H.3 As part of the team’s exploration of quality improvement and medical informatics, they particularly looked at how to adapt products to be workflow sensitive.

And one of the most important things Dr. Lee says he would tell his counterparts at other institutions is “to ensure that computerized solutions for safety and documentation are appropriately matched to the work flow.” He thinks that when these initiatives fail it is often due to an underappreciation of the impact that these changes and enhancements have on actual provision of care. “Do those things that are [the] most highly successful, leverage moments that you’re going to do anyway, but then automate it, make it safer, make it more comprehensive,” he says. “That’s my challenge to my colleagues.”—AS

Modern medicine … certainly as it should be practiced by hospitalists, is the most information-intensive activity that human beings ever engaged in,” says Kenneth W. Kizer, MD, MPH, CEO and chairman of the board of Medsphere Systems Corporation in Aliso Viejo, Calif.

He should know. From his first healthcare-related position in 1969 as a hospital orderly at Stanford University Hospital, he rose to become the Under Secretary for Health in the Department of Veterans Affairs (VA)—the CEO of the largest healthcare system in the nation. He is widely credited as being the chief architect and driving force behind the successful transformation of VA healthcare in the 1990s.

The VA’s 154 hospitals and 875 clinics, which serve 5.4 million patients, have been rated “best in class” by a number of independent groups since it implemented the changes in the 1990s.1 In a study conducted by the Rand Corporation, the VA scored higher compared with the U.S. private sector hospitals in every category except acute care, in which “the numbers ran neck and neck,” says Dr. Kizer. “Where the VA has done much better [than private sector hospitals] is in managing chronic disease and integrating prevention and health maintenance into the acute care program.”

Differences between a VA facility and one in the private sector are mostly “cosmetic and in the financing,” says Dr. Kizer. “The VA takes care of a particular patient population—veterans of military service—but it is a civilian practice that happens to be run by the federal government.”

According to a July 17, 2006, article in BusinessWeek, “The Best Medical Care in the U.S.,” the VA system provides about two-thirds of the care protocols recommended by organizations such as the Agency for Healthcare Research and Quality, compared with 50% provided in private sector hospitals.1 Also, as many as 8% of the prescriptions filled in private sector hospitals contain errors, but the VA’s prescription-related accuracy is greater than 99.997%. In addition, the VA spends an average of $5,000 per patient compared with the national average of $6,300.

Dr. Kizer’s focus on quality improvement at the VA should not be surprising in view of his long-time focus on improving the quality of healthcare. In his mind, an essential element in improving the quality of American healthcare is the widespread adoption of electronic health records (EHR).

When he arrived at his post at the VA in 1994, Dr. Kizer was pleasantly surprised to find advanced automated information management in place. The VA had been working on developing an EHR since 1978. As part Kizer’s transformation of the VA, all of the VA’s information systems were integrated, and VistA (an acronym for Veterans Health Information Systems and Technology Architecture) was launched in 1997. VistA is often the first thing that VA-affiliated hospitalists mention when they are asked what distinguishes VA hospitals from non-VA hospitals.

Key Features and Benefits of the VA

Sanjay Saint, MD, knows a great deal about academically affiliated VAs. He was a resident (July 1993-June 1995) and then chief medical resident at the San Francisco VA (June 1995-June 1996), an affiliate of the University of California at San Francisco. He was also a fellow at the University of Washington-affiliated Seattle VA (July 1996-June 1998), and for more than eight years he has been on the faculty at the University of Michigan as a professor of internal medicine (1998-2006). Dr. Saint is currently a hospitalist at the University of Michigan-affiliated Ann Arbor VA Hospital. He was also recently the acting chief of medicine there for six months (Dec. 2005-May 2006) while the permanent chief was on sabbatical.

The instant availability of the EHR system is a key benefit of practicing in a VA hospital, says Dr. Saint. “It involves not only being able to get up-to-date, relevant patient information at our VA but also the information obtained if the patient has been seen at other VAs.”

“One of the reasons why [the VA’s EHR] is so good is that it is fully integrated,” says Dr. Kizer. “Everything was made to fit together to begin with—in contrast to essentially all commercial products, which have been melded together from pieces that come from a variety of origins. Being fully integrated certainly increases the speed and efficiency of operations. The second reason why VistA is so good is that it was developed by clinicians for clinicians … .”

A key feature operating as part of the EHR is the focus on computer-based provider order entry (CPOE). CPOE can help physicians make correct clinical decisions, says Dr. Saint. He cites the example of a pilot test he and co-workers conducted at the Seattle VA: After 72 hours of urinary catheterization in a patient, an alert reminded physicians to remove the catheter. From that simple type of quality improvement experiment, the data revealed that those patients for whom the reminder had been used had a significantly reduced rate of infection compared with those for whom it had not.

One particularly good, but perhaps underutilized, aspect of the computerized system is the use of care protocols or models that can be used across the VA, says Peter Kaboli, MD, MS, hospitalist at the Iowa City VA Hospital, an affiliate of the University of Iowa. “And we could probably … have more available electronically [that] could be modified for the local care environment,” he says, adding that insulin protocols come to mind first.

Another key EHR feature is an extensive adverse event reporting system, including registering near misses. About 96% of prescriptions and physician orders are entered with the system; in private sector hospitals, the rough estimate is 8%. There is also a bar-coding system for verification of medications and identification of patients. The VA “has done a great job of changing the culture to foster systems-based care and to address errors and adverse patient outcomes straightforward[ly] and deal with them up front.”

Another distinguishing feature of the VA, says Dr. Saint, is its heavy investment in quality improvement and health services research (HSR). The VA has large repositories of administrative and clinical data for performing research with hospitalized patients. Dr. Saint also points out that a lot of the academic centers benefit from having a VA as an affiliate. “The house staff, medical students, and physicians often will be at the VA [and can] see the state-of-the-art electronic medical records and CPOE system and inquire, ‘Why can’t we have that at the university hospital?’ ”

Discharge: Seamless Transition

Dr. Kaboli can point to another advantage for hospital medicine in the VA: a concerted interest in developing hospitalists. Two-thirds of VA medical centers (VAMCs) use hospitalists, and two-thirds of inpatients are cared for by hospitalists. In total, approximately 400 hospitalists are employed by the VA, making it the largest single employer of hospitalists in the United States. Within two years, 75% of VAMCs will use hospitalists.2

Dr. Kaboli has also become well versed on the advantages of the VA’s EHR in the area of patient discharge. The greatest benefit to hospitalists of having a fully integrated medical record with CPOE and all inpatient and outpatient notes available in all the VA facilities across the country, he says, “is the almost seamless transition of these records both from the clinic side to the hospital and from the hospital back to the clinic.”

One “great luxury” of having that integrated system, Dr. Kaboli adds, is that a hospitalist can hand patients their discharge summaries and advise them to pass the information on in the next doctor’s visit. “Even though you’re going to send it via e-mail, [in a] fax, or by mail, you have that as another option to translate that information to other docs,” he explains. Hospitalists can also “alert other providers by making them co-signers to notes so that when it comes into their inbox, they know that a patient was discharged, and they get the discharge summary immediately.”

There is no connection electronically with non-VA providers, however, which is the same situation that exists in any other non-VA healthcare system. “We know [that] a fairly large percentage of veterans receive care, both within and outside the VA, who are what we call co-managed,” says Dr. Kaboli. “If a patient doesn’t live near a VA hospital or clinic, he may have to travel an hour or two, so that person might as well have a local doctor. Without that [EHR system], if [the patient is] speaking to a primary care physician in a local community, [that physician is] up against the same challenges as [someone who works] outside the VA.”

Get on the EHR Bandwagon

“The federal government has a crucial leadership role in promoting a national health information infrastructure,” said Dr. Kizer in his June 17, 2004 testimony to Congress. When asked about that statement, Dr. Saint (who is also director of the VA/University of Michigan Patient Safety Enhancement Program) has one piece of advice for his hospitalist colleagues. “You don’t want perfect to become the enemy of the very good,” he says. “Rather than waiting until there is a national technology information infrastructure, which may be years—if not decades—away, you can at least advocate for change in your own hospital.”

Use the VA as a model, he says. “You don’t have to use the exact same system, but at least you can point to some of the quality advantages that electronic medical records and CPOE can provide. You can also point out some of the advantages that investment in quality improvement and health services research can bring to an organization and say, ‘We can adapt—not necessarily adopt—what the VA has done.’ ”

How can hospitalists best do that? Many publications in the peer-reviewed literature address the quality improvement focus of the VA. There is also a VA Web site that discusses the focus on HSR and development (www1. va.gov/health). A VA-sponsored national health services research and development (HSR&D) meeting, at which investigators from all over the country present their latest findings, is held annually in Washington, D.C., usually in February.

For the young hospitalist who wants to pursue additional training, Dr. Saint says, there are VA-funded fellowships, HSR&D, a quality scholars program, and other career development opportunities within the VA that promote leadership roles both in and outside the VA.

Dr. Kaboli suggests identifying networks of hospitalists within and outside of your own healthcare system that you can work with and learn from. Hospitalists can also collaborate in developing protocols that incorporate local modifications. Also, he suggests, “there are a lot of questions that come up in the day-to-day care of patients. If you have colleagues as interested as you are, as hospitalists, in the quality of care for hospitalized medical patients, you can tap into that passion. The SHM listservs are a great way to connect; one for VA hospitalists has just been organized.

Anyone interested in the OpenVista Electronic Health Record, Medsphere’s commercial product (which, Dr. Kizer says, “is VistA at the core” and is being marketed to hospitals and large clinics) can learn more at www.medsphere.com.

Dr. Kizer says hospitalists will need to understand the needs of future healthcare and help prepare for and welcome it. “For example, performance measurement is an absolute part of the future of healthcare,” he says. “I think, by and large, hospitalists understand that better and are more accepting of that than certainly most docs in private practice.”

He believes hospitalists “can help promote that understanding among their peers and their hospitals and keep moving things forward as opposed to resisting it.” This is just one aspect of the “openness and transparency that we want to see in so many areas,” says Dr. Kizer, and hospitalists can be “pushing for the tools to make it happen. The hospitalists, I would think, should be leading the charge for electronic health records.”

Now and Tomorrow

Dr. Kizer, who is one of nine experts on veterans’ issues named to the newly formed Commission on the Future for America’s Veterans and is board certified in six medical specialties, also has a personal view on the work of hospital medicine. Recently, his wife was hospitalized in the ICU at the University of California at Davis Medical Center for a number of months, and Dr. Kizer says that a succession of hospitalists have served as her principal providers. It’s given him a more intimate view of what matters, beyond strictly clinical care, to patients and their families.

“By and large, I’ve always supported the hospitalist notion,” he says, “because it … supports my view [that] keeping up to date on all the science and technology and running an office practice [at the same time] is just more than you can reasonably expect anyone to do.” What he has especially noticed now, as a family caregiver visiting a hospital, “is that there is tremendous variability in how much [hospitalists] communicate with the patient and his or her family and how they view the episode of care within the context of the family and their community.”

Dr. Kizer, who has studied communications for a long time and in myriad ways, notes that a lot of the hospitalists he has met during this recent experience “think they’re communicating, but they often don’t take the time to determine if they are actually connecting with the family or addressing the issues that are important to the patient and family.”

In the same vein, he agrees that the better the electronic communication systems of a healthcare system—including proficiency in identifying medical errors—the more minutes can be freed up for a physician to pull up a chair and talk with a patient. “It is also a powerful tool to educate and to help inform,” he says. “For example, when [a hospitalist] can just quickly graph out where the patient’s blood pressure … or blood sugars or … creatinine has been, you can use the display of data to quickly educate the patient and/or the family about what has happened and where you need to go. One picture can save you 10 minutes of explaining.”

Conclusion

The VA has taken a lead in addressing the issues that have been brought up over the years by organizations such as the Institute of Medicine and the Institute for Healthcare Improvement. Their integrated electronic health records system can serve as a model for non-VA hospitals. Until there is a national integration of computerized technology, hospitalists can become advocates for improving their own hospital technology systems. “Electronic health records and hospitalists should go hand in glove,” concludes Dr. Kizer. “It’s potentially a great marriage of technology and the human element.” TH

Andrea Sattinger is a regular contributor to The Hospitalist.

References

1. Arnst C. The best medical care in the U.S.: How Veterans Affairs transformed itself—and what it means for the rest of us. BusinessWeek online. July 17, 2006. Available at www.businessweek.com/magazine/content/06_29/b3993061.htm?chan=top+news_top+news. Last accessed October 20, 2006.
2. Kaboli PJ, Barrett T, Vazirani S, et al. Growth of hospitalists in the Veterans Administration (VA) healthcare system: 1997-2005. Hosp Med. Abstract. 2006;1(S2):1-30.
3. Lurie JD, Merrens EJ, Lee J, et al. An approach to hospital quality improvement. Med Clin North Am. 2002 Jul;86(4):825-845.

A Hospitalist Revolutionizes UCSD’s Online Clinical Systems

Josh Lee, MD, is a hospitalist. But Dr. Lee is also a computer geek, and the combination has served him and patient care well.

As medical director of Information Services at the University of California at San Diego (UCSD), Dr. Lee has oversight over all online clinical systems, and that is no small task. With Dr. Lee’s guidance, UCSD is now a leader in the medical informatics movement. With the exception of physician documentation, the system has comprehensive electronic records; that is, some physicians still prefer to “wet-sign” their notes. Lab results at UCSD are 100% electronic, as is order entry for adult inpatients. “We have now completed what we call the entire order life cycle: physician orders, direct integrations through our pharmacy, pharmacy validation, and bar-coded administration at bedside,” he says.

As opposed to the VA’s homegrown EHR, UCSD did what many healthcare systems do: They bought an off-the-shelf product—this one was Invision from Siemens—but UCSD calls their product PCIS, for Patient Care Information Services.

“A lot of people are able to do cool stuff [with medical informatics],” says Dr. Lee, “but they have done it with a proprietary product, so it’s different than VA, where they are using something they have total control over.”

He says many people are now focused on order entry, “but I think the newest area of research and integration [involves the question], how do we communicate key clinical issues and follow-up for discharge?” (See Figure 1, above.) At UCSD Medical Center, these screens can be printed and the pages given directly to the patient upon discharge.) “We have leveraged our electronic system to ensure that, at the moment of discharge, not only is the patient informed about [his or her] care, but it is clear to anybody on our side, or from the side of the receiving physician, what is supposed to happen next.”

As any hospitalist knows, there can be a huge “voltage drop” in this area, as Robert Wachter, MD, professor and associate chairman at UCSF’s Department of Medicine, San Francisco, refers to it. Dr. Wachter is

And the great advantages of the VA’s electronic products are not available to the “99% of American hospitalists who don’t practice in closed systems,” says Dr. Lee.

Because most hospitalists don’t have that advantage, careful and complete discharge communications are imperative. That’s why UCSD built screens that can accommodate the specific information patients need, he says. “It’s different from the classic discharge summary, which is usually a lengthy, unwieldy, dictated document that is mostly [composed] after the patient leaves the hospital. This is done in real time … and these print-outs are immediately available for the patient.”

Before Dr. Lee came to UCSD, he worked with Drs. Jon Lurie, Mark Splaine, and Ed Merrens, all members of the general internal medicine division at Dartmouth-Hitchcock Medical Center in Hanover, N.H.3 As part of the team’s exploration of quality improvement and medical informatics, they particularly looked at how to adapt products to be workflow sensitive.

And one of the most important things Dr. Lee says he would tell his counterparts at other institutions is “to ensure that computerized solutions for safety and documentation are appropriately matched to the work flow.” He thinks that when these initiatives fail it is often due to an underappreciation of the impact that these changes and enhancements have on actual provision of care. “Do those things that are [the] most highly successful, leverage moments that you’re going to do anyway, but then automate it, make it safer, make it more comprehensive,” he says. “That’s my challenge to my colleagues.”—AS

Patient discharged from group therapy kills psychiatrist, patient, and himself

Oakland County (MI) Circuit Court

The plaintiff, age 57, attended regular group therapy with a psychiatrist. Another patient, Mr. B, was dismissed from group therapy by the psychiatrist, but returned to the office with a gun during one of the regular sessions. Mr. B shot and killed the psychiatrist then entered the group meeting room and discharged his gun, fatally injuring another patient and wounding the plaintiff. Mr. B then turned the gun on himself and committed suicide. The plaintiff suffered gunshot wounds to the lower leg, foot, and hand and was away from work for 6 weeks.

The plaintiff alleged that the psychiatrist, his associates, and his daughter—who is also a psychiatrist at the office—knew Mr. B was dangerous and should not have been included in group therapy. The plaintiff claimed that Mr. B had a history of questionable psychotic behavior and other patients should not have been exposed to him. The psychiatrist’s associates contended that they had no way to anticipate this event and had used due care and caution in their practice.

• A $2 million verdict was returned
  

Dr. Grant’s observations

Warn and protect

In this case, several unavailable facts may have supported the successful negligence claim. For example, why was Mr. B dismissed from the group? Did he threaten someone in the group? Did he tell the group or the group leader about thoughts of violence or homicide? If so, perhaps a violent event was foreseeable.

Was Mr. B dismissed because of delusional or paranoid thoughts? What was done to help him, and were appropriate referrals in place? Instituting the right interventions requires clinicians to walk a fine line between preserving doctor-patient confidentiality and protecting other patients and the general public.

Doctor-patient confidentiality is deeply rooted in medical ethics and protected by law—in various forms—in all jurisdictions. Directives requiring a physician to reveal information without a patient’s consent are either legislated—and tend to be clear—or are based on court precedent, which is more open to interpretation. These mandated exceptions are purpose-specific and intended to preserve overall doctor-patient confidentiality.^{“Is this patient dangerous?” by John Battaglia, MD, and “Protect yourself from patient assault”, an interview between Dr. Battaglia and Lois E. Krahn, MD.}

Patient discharged from group therapy kills psychiatrist, patient, and himself

Oakland County (MI) Circuit Court

The plaintiff, age 57, attended regular group therapy with a psychiatrist. Another patient, Mr. B, was dismissed from group therapy by the psychiatrist, but returned to the office with a gun during one of the regular sessions. Mr. B shot and killed the psychiatrist then entered the group meeting room and discharged his gun, fatally injuring another patient and wounding the plaintiff. Mr. B then turned the gun on himself and committed suicide. The plaintiff suffered gunshot wounds to the lower leg, foot, and hand and was away from work for 6 weeks.

The plaintiff alleged that the psychiatrist, his associates, and his daughter—who is also a psychiatrist at the office—knew Mr. B was dangerous and should not have been included in group therapy. The plaintiff claimed that Mr. B had a history of questionable psychotic behavior and other patients should not have been exposed to him. The psychiatrist’s associates contended that they had no way to anticipate this event and had used due care and caution in their practice.

• A $2 million verdict was returned
  

Dr. Grant’s observations

Warn and protect

In this case, several unavailable facts may have supported the successful negligence claim. For example, why was Mr. B dismissed from the group? Did he threaten someone in the group? Did he tell the group or the group leader about thoughts of violence or homicide? If so, perhaps a violent event was foreseeable.

Was Mr. B dismissed because of delusional or paranoid thoughts? What was done to help him, and were appropriate referrals in place? Instituting the right interventions requires clinicians to walk a fine line between preserving doctor-patient confidentiality and protecting other patients and the general public.

Doctor-patient confidentiality is deeply rooted in medical ethics and protected by law—in various forms—in all jurisdictions. Directives requiring a physician to reveal information without a patient’s consent are either legislated—and tend to be clear—or are based on court precedent, which is more open to interpretation. These mandated exceptions are purpose-specific and intended to preserve overall doctor-patient confidentiality.^{“Is this patient dangerous?” by John Battaglia, MD, and “Protect yourself from patient assault”, an interview between Dr. Battaglia and Lois E. Krahn, MD.}

Patient discharged from group therapy kills psychiatrist, patient, and himself

Oakland County (MI) Circuit Court

The plaintiff, age 57, attended regular group therapy with a psychiatrist. Another patient, Mr. B, was dismissed from group therapy by the psychiatrist, but returned to the office with a gun during one of the regular sessions. Mr. B shot and killed the psychiatrist then entered the group meeting room and discharged his gun, fatally injuring another patient and wounding the plaintiff. Mr. B then turned the gun on himself and committed suicide. The plaintiff suffered gunshot wounds to the lower leg, foot, and hand and was away from work for 6 weeks.

The plaintiff alleged that the psychiatrist, his associates, and his daughter—who is also a psychiatrist at the office—knew Mr. B was dangerous and should not have been included in group therapy. The plaintiff claimed that Mr. B had a history of questionable psychotic behavior and other patients should not have been exposed to him. The psychiatrist’s associates contended that they had no way to anticipate this event and had used due care and caution in their practice.

• A $2 million verdict was returned
  

Dr. Grant’s observations

Warn and protect

In this case, several unavailable facts may have supported the successful negligence claim. For example, why was Mr. B dismissed from the group? Did he threaten someone in the group? Did he tell the group or the group leader about thoughts of violence or homicide? If so, perhaps a violent event was foreseeable.

Was Mr. B dismissed because of delusional or paranoid thoughts? What was done to help him, and were appropriate referrals in place? Instituting the right interventions requires clinicians to walk a fine line between preserving doctor-patient confidentiality and protecting other patients and the general public.

Doctor-patient confidentiality is deeply rooted in medical ethics and protected by law—in various forms—in all jurisdictions. Directives requiring a physician to reveal information without a patient’s consent are either legislated—and tend to be clear—or are based on court precedent, which is more open to interpretation. These mandated exceptions are purpose-specific and intended to preserve overall doctor-patient confidentiality.^{“Is this patient dangerous?” by John Battaglia, MD, and “Protect yourself from patient assault”, an interview between Dr. Battaglia and Lois E. Krahn, MD.}

New findings questioning the value of second-generation antipsychotics (SGAs) for treating acute behaviors in patients with Alzheimer’s disease have raised more questions on when and how to use these agents in the elderly.

The National Institute of Mental Health-sponsored Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer’s disease (CATIE-AD) concluded that SGAs offer no overall advantage over placebo. Although SGAs helped some trial patients, the medications were discontinued for approximately 8 in 10 patients because of intolerable side effects or ineffectiveness.

CATIE-AD’s principal investigator says the findings—published in the October 12 New England Journal of Medicine¹—will guide clinicians in adjusting SGA dosages and durations for older patients with dementia.

But other psychiatrists argue that the study—led by prominent researchers and published in a prestigious medical journal—will deter clinicians from trying SGAs for older patients with dementia-related psychosis, aggression, or agitation.

“These drugs are not FDA-approved for dementia. They may cause diabetes. They cause weight gain. They carry boxed warnings that they could increase risk of stroke and—in patients over age 85—can increase risk of dying,” says Sumer Verma, MD, director of the geriatric psychiatry education program at McLean Hospital (Belmont, MA). “Doctors already were reluctant to use SGAs, and now these researchers publish this study in one of the country’s most respected journals and make an unqualified statement to the effect that [SGAs] are no better than placebo. How many clinicians will be comfortable prescribing them?”

Box

‘Discouraging’ discontinuation

CATIE-AD—a double-blind, multicenter, randomized trial (Box)—followed 421 ambulatory outpatients with Alzheimer’s disease and psychosis, aggression, or agitation. Patients received the SGAs olanzapine (mean dosage, 5.5 mg/d), quetiapine (mean 56.5 mg/d), risperidone (mean 1 mg/d), or placebo. Dosages were adjusted as needed.

After 36 weeks, times to discontinuation because of lack of efficacy were longest for olanza-pine and risperidone, but these drugs also had the highest rates of discontinuation because of intolerability (24% and 18%, respectively). Quetiapine’s rate of discontinuation because of intolerability was 16%.

SGAs were stopped because of lack of efficacy or intolerable side effects—such as parkinsonism, extrapyramidal symptoms, sedation, or weight gain—in:

• 63% of treatment and placebo group patients within 12 weeks
• 82% of all patients within 36 weeks.

Lon Schneider, MD, principal investigator for CATIE-AD, acknowledged that the findings could discourage psychiatrists from prescribing SGAs for acute dementia-related behaviors, specifically in patients with Alzheimer’s disease.

But although discontinuation because of intolerability was most prevalent among patients taking risperidone or olanzapine, both SGAs were more effective than placebo for treating problem behaviors in some participants, Dr. Schneider notes. He adds that the patient population and most SGA dosages in CATIE-AD reflected typical geriatric psychiatric practice in the community.

An editorial in the October 12 New England Journal of Medicine² praised CATIE-AD for allowing physicians to titrate and stop SGA regimens as needed while maintaining the double-blind design. Results of fixed-dose trials with prespecified time points are more difficult to apply to clinical practice because the course of Alzheimer’s disease and patients’ ability to tolerate specific drugs change over time.²

“This study can inform clinicians that they should not be prescribing medication and then not following up or maintaining it indefinitely,” says Dr. Schneider, who is professor of psychiatry, neurology and gerontology, University of Southern California, Los Angeles.

‘Black box’ fears?

Dr. Verma, however, reports that many clinicians have been hesitant to prescribe SGAs to older patients since last year—when the FDA ordered that SGAs carry “black box” warnings of a possible increased mortality risk in that population.

“CATIE-AD will intensify clinicians’ fears of litigation by implying that the risks of using SGAs outweigh their benefits, especially when SGAs are reported to be no better than placebo,” Dr. Verma predicts. “A lawyer could say to a clinician, ‘You used an SGA on Mr. Smith despite the risks, and he developed XYZ complication?’ Try to work yourself out of that one.

“A paper like this will be snapped up by pharmacy and therapeutics committees around the country, as well as Medicare, Medicaid, and other insurers,” Dr. Verma adds. “They’ll say, ‘These expensive drugs are no better than placebo. Why bother covering them?’”

Echoing Dr. Verma’s fears, the American Association for Geriatric Psychiatry (AAGP) responded to CATIE-AD by urging regulatory agencies not to overreact to the findings or “prevent physicians from exercising clinical judgment.”³ AAGP also is calling for more research “based on clinical and evidence-based protocols designed to help physicians know when and how to start, continue, and discontinue psychotropics” for older patients.³

Another problem with generalizing the CATIE-AD findings, Dr. Verma says, is that many Alzheimer’s patients are more severely impaired than those who participated in CATIE-AD.

“These are people who cannot be managed,” adds Barbara Kamholz, MD, clinical associate professor, University of Michigan, and staff psychiatrist, VA Medical Center, Ann Arbor. “They can’t get through the day. They can’t eat or use the bathroom properly. You can’t treat their medical problems if you can’t manage grossly abusive or violent behaviors.”

Dr. Schneider, however, notes that the outpatients in CATIE-AD were nearly as symptomatic as patients in nursing homes—as suggested by CATIE-AD patients’ mean Brief Psychiatric Rating Scale and Neuropsychiatric Inventory scores (28 and 37, respectively).

Also, Dr. Schneider says, most trials of SGAs conducted among nursing home patients have not yielded statistically significant results.⁴

‘Informing’ practice

Dr. Schneider warns against drastic interpretation of CATIE-AD, saying the trial should guide clinical practice, not radically alter it. He says he will keep prescribing SGAs for short-term acute treatment of older patients whose behavioral problems do not respond to psychosocial interventions, distraction, redirection, environmental manipulation, or other treatments.

“I’m not sure this study has changed my use of [SGAs],” Dr. Schneider says. “What it has done is better inform my considerations in prescribing. But I use [SGAs] in patients with significant behavioral problems—and especially with delusions, paranoia and aggression—who can’t be otherwise treated.”

Studies show that despite their risks, SGAs:

• are associated with one-tenth the risk of tardive dyskinesia compared with first-generation antipsychotics (FGAs) such as haloperidol⁵
• are less likely to cause extrapyramidal symptoms than FGAs.⁶

Dr. Verma notes that the cardiac, cerebrovascular, and cardiopulmonary side effects described in the “black box” warnings on SGAs are prevalent conditions in the elderly, independent of medication.

“Despite the side effects, 20% to 30% of patients [in CATIE-AD] continued to take [SGAs] for the entire study,”

Dr. Verma adds. “[SGAs] are not perfect drugs, but they’re the best we’ve got right now and better than what we had.”

Dr. Schneider acknowledges that no evidence supports use of other drug classes to treat problem behaviors in the elderly. “Antidepressants have their own adverse effects, and you wouldn’t expect them to work for delusions or aggression. And benzodiazepines are strongly associated with falling and oversedation.”

Dr. Kamholz fears that some psychiatrists might eschew SGAs in older patients and prescribe another type of medication that carries a greater side-effect risk.

“If they’re not using [SGAs], they might be using something more dangerous,” Dr. Kamholz says. “For example, haloperidol is an old standby, but very few studies address its global effects. So we’re groping around in the dark. I’ve also seen some bad deliriums caused by benzodiazepines.”

When to prescribe SGAs

At what point does the need to manage psychosis, aggression, or agitation in Alzheimer’s disease outweigh SGAs’ risks?

“Frankly, I’d rather not use medications unless I have to—and then only enough to preserve function while treating the behavioral disturbance,” Dr. Verma says. “I don’t want to anesthetize these patients. I just want to maintain their function, dignity, and quality of life.”

Seeking other causes of acute behaviors is essential before prescribing an SGA, Drs. Verma and Schneider say. Psychotic disorientation, for example, can occur with underlying psychiatric problems (such as delirium), hearing and sight deficits, disrupted schedules, poor sleep and appetite, incontinence, pain, unrelated medical complications, or environmental stressors.

For many older patients with problem behaviors, SGAs are worth the risk after other interventions have failed, Dr. Kamholz says. Weighing behavioral against pharmacologic risks is key, Dr. Schneider adds.

“What are the consequences of the behavior or paranoid ideation?” Dr. Schneider asks. “What about when the patient is refusing food? Or when caregivers cannot approach the patient, or the behavior creates a rift between family members so that the patient’s basic needs cannot be met? If psychosocial and environmental interventions haven’t worked, [SGAs] are worth a try.”

Because acute behavior hastens caregiver burnout—a major cause of nursing home admission⁶—appropriate SGA use also can help older patients remain at home, Drs. Schneider, Kamholz, and Verma say.

Practical applications

Drs. Schneider, Verma, and Kamholz agree that SGAs are a short-term intervention for problem behaviors in dementia. Because Alzheimer’s symptoms wax and wane as the disease progresses, patients need to be monitored continually, and medication regimens should be modified as needed and discontinued if possible.

Dr. Verma advises starting risperidone, olanza-pine, or quetiapine at low dosages, titrating slowly, and monitoring the patient carefully (Table).

Dr. Schneider suggests discontinuing the SGA after 12 to 20 weeks in patients who have responded. If behavior worsens after an SGA is discontinued, restart the medication, he says.

“If patients have adverse events with SGAs, do not try to tough it out,” Dr. Schneider adds. “Either adjust medications to eliminate adverse events or change the medication. If patients have been tolerating the medication for, say, 12 weeks, that doesn’t mean adverse reactions cannot develop later, so be ready to make adjustments.”

To guard against medicolegal risk when prescribing SGAs to older patients, Dr. Verma suggests that you clearly document:

• the reason you are prescribing the SGA
• your understanding of the risk/benefit ratio in using SGAs and that, in your clinical judgment, using an SGA in this patient is warranted because the benefits outweigh the risks
• that you considered other medications and the reasons those medications are inappropriate (for example, “I opted against a benzodiazepine because it could be too sedating and could increase the risk of falls and consequent injury”).

Also, get updates from the patient’s primary care physician on the patient’s cardiopulmonary and cerebrovascular health. Finally, provide extensive information about SGAs’ risks to family members, and keep signed documentation that you provided these warnings.

Table

Recommended second-generation antipsychotic dosing for older patients

Related resources

• American Association for Geriatric Psychiatry. AAGP position statement: Principles of care for patients with dementia resulting from Alzheimer disease.www.aagponline.org/prof/position_caredmnalz.asp.

Drug brand names

• Haloperidol • Haldol
• Olanzapine • Zyprexa
• Quetiapine • Seroquel
• Risperidone • Risperdal

Acknowledgment

Peter A. Kelly is senior editor, Current Psychiatry.

Lynn Waltz, a medical writer and editor in Norfolk, VA, helped prepare this article from transcripts of interviews with Drs. Kamholz, Schneider, and Verma.

New findings questioning the value of second-generation antipsychotics (SGAs) for treating acute behaviors in patients with Alzheimer’s disease have raised more questions on when and how to use these agents in the elderly.

The National Institute of Mental Health-sponsored Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer’s disease (CATIE-AD) concluded that SGAs offer no overall advantage over placebo. Although SGAs helped some trial patients, the medications were discontinued for approximately 8 in 10 patients because of intolerable side effects or ineffectiveness.

CATIE-AD’s principal investigator says the findings—published in the October 12 New England Journal of Medicine¹—will guide clinicians in adjusting SGA dosages and durations for older patients with dementia.

But other psychiatrists argue that the study—led by prominent researchers and published in a prestigious medical journal—will deter clinicians from trying SGAs for older patients with dementia-related psychosis, aggression, or agitation.

“These drugs are not FDA-approved for dementia. They may cause diabetes. They cause weight gain. They carry boxed warnings that they could increase risk of stroke and—in patients over age 85—can increase risk of dying,” says Sumer Verma, MD, director of the geriatric psychiatry education program at McLean Hospital (Belmont, MA). “Doctors already were reluctant to use SGAs, and now these researchers publish this study in one of the country’s most respected journals and make an unqualified statement to the effect that [SGAs] are no better than placebo. How many clinicians will be comfortable prescribing them?”

Box

‘Discouraging’ discontinuation

CATIE-AD—a double-blind, multicenter, randomized trial (Box)—followed 421 ambulatory outpatients with Alzheimer’s disease and psychosis, aggression, or agitation. Patients received the SGAs olanzapine (mean dosage, 5.5 mg/d), quetiapine (mean 56.5 mg/d), risperidone (mean 1 mg/d), or placebo. Dosages were adjusted as needed.

After 36 weeks, times to discontinuation because of lack of efficacy were longest for olanza-pine and risperidone, but these drugs also had the highest rates of discontinuation because of intolerability (24% and 18%, respectively). Quetiapine’s rate of discontinuation because of intolerability was 16%.

SGAs were stopped because of lack of efficacy or intolerable side effects—such as parkinsonism, extrapyramidal symptoms, sedation, or weight gain—in:

• 63% of treatment and placebo group patients within 12 weeks
• 82% of all patients within 36 weeks.

Lon Schneider, MD, principal investigator for CATIE-AD, acknowledged that the findings could discourage psychiatrists from prescribing SGAs for acute dementia-related behaviors, specifically in patients with Alzheimer’s disease.

But although discontinuation because of intolerability was most prevalent among patients taking risperidone or olanzapine, both SGAs were more effective than placebo for treating problem behaviors in some participants, Dr. Schneider notes. He adds that the patient population and most SGA dosages in CATIE-AD reflected typical geriatric psychiatric practice in the community.

An editorial in the October 12 New England Journal of Medicine² praised CATIE-AD for allowing physicians to titrate and stop SGA regimens as needed while maintaining the double-blind design. Results of fixed-dose trials with prespecified time points are more difficult to apply to clinical practice because the course of Alzheimer’s disease and patients’ ability to tolerate specific drugs change over time.²

“This study can inform clinicians that they should not be prescribing medication and then not following up or maintaining it indefinitely,” says Dr. Schneider, who is professor of psychiatry, neurology and gerontology, University of Southern California, Los Angeles.

‘Black box’ fears?

Dr. Verma, however, reports that many clinicians have been hesitant to prescribe SGAs to older patients since last year—when the FDA ordered that SGAs carry “black box” warnings of a possible increased mortality risk in that population.

“CATIE-AD will intensify clinicians’ fears of litigation by implying that the risks of using SGAs outweigh their benefits, especially when SGAs are reported to be no better than placebo,” Dr. Verma predicts. “A lawyer could say to a clinician, ‘You used an SGA on Mr. Smith despite the risks, and he developed XYZ complication?’ Try to work yourself out of that one.

“A paper like this will be snapped up by pharmacy and therapeutics committees around the country, as well as Medicare, Medicaid, and other insurers,” Dr. Verma adds. “They’ll say, ‘These expensive drugs are no better than placebo. Why bother covering them?’”

Echoing Dr. Verma’s fears, the American Association for Geriatric Psychiatry (AAGP) responded to CATIE-AD by urging regulatory agencies not to overreact to the findings or “prevent physicians from exercising clinical judgment.”³ AAGP also is calling for more research “based on clinical and evidence-based protocols designed to help physicians know when and how to start, continue, and discontinue psychotropics” for older patients.³

Another problem with generalizing the CATIE-AD findings, Dr. Verma says, is that many Alzheimer’s patients are more severely impaired than those who participated in CATIE-AD.

“These are people who cannot be managed,” adds Barbara Kamholz, MD, clinical associate professor, University of Michigan, and staff psychiatrist, VA Medical Center, Ann Arbor. “They can’t get through the day. They can’t eat or use the bathroom properly. You can’t treat their medical problems if you can’t manage grossly abusive or violent behaviors.”

Dr. Schneider, however, notes that the outpatients in CATIE-AD were nearly as symptomatic as patients in nursing homes—as suggested by CATIE-AD patients’ mean Brief Psychiatric Rating Scale and Neuropsychiatric Inventory scores (28 and 37, respectively).

Also, Dr. Schneider says, most trials of SGAs conducted among nursing home patients have not yielded statistically significant results.⁴

‘Informing’ practice

Dr. Schneider warns against drastic interpretation of CATIE-AD, saying the trial should guide clinical practice, not radically alter it. He says he will keep prescribing SGAs for short-term acute treatment of older patients whose behavioral problems do not respond to psychosocial interventions, distraction, redirection, environmental manipulation, or other treatments.

“I’m not sure this study has changed my use of [SGAs],” Dr. Schneider says. “What it has done is better inform my considerations in prescribing. But I use [SGAs] in patients with significant behavioral problems—and especially with delusions, paranoia and aggression—who can’t be otherwise treated.”

Studies show that despite their risks, SGAs:

• are associated with one-tenth the risk of tardive dyskinesia compared with first-generation antipsychotics (FGAs) such as haloperidol⁵
• are less likely to cause extrapyramidal symptoms than FGAs.⁶

Dr. Verma notes that the cardiac, cerebrovascular, and cardiopulmonary side effects described in the “black box” warnings on SGAs are prevalent conditions in the elderly, independent of medication.

“Despite the side effects, 20% to 30% of patients [in CATIE-AD] continued to take [SGAs] for the entire study,”

Dr. Verma adds. “[SGAs] are not perfect drugs, but they’re the best we’ve got right now and better than what we had.”

Dr. Schneider acknowledges that no evidence supports use of other drug classes to treat problem behaviors in the elderly. “Antidepressants have their own adverse effects, and you wouldn’t expect them to work for delusions or aggression. And benzodiazepines are strongly associated with falling and oversedation.”

Dr. Kamholz fears that some psychiatrists might eschew SGAs in older patients and prescribe another type of medication that carries a greater side-effect risk.

“If they’re not using [SGAs], they might be using something more dangerous,” Dr. Kamholz says. “For example, haloperidol is an old standby, but very few studies address its global effects. So we’re groping around in the dark. I’ve also seen some bad deliriums caused by benzodiazepines.”

When to prescribe SGAs

At what point does the need to manage psychosis, aggression, or agitation in Alzheimer’s disease outweigh SGAs’ risks?

“Frankly, I’d rather not use medications unless I have to—and then only enough to preserve function while treating the behavioral disturbance,” Dr. Verma says. “I don’t want to anesthetize these patients. I just want to maintain their function, dignity, and quality of life.”

Seeking other causes of acute behaviors is essential before prescribing an SGA, Drs. Verma and Schneider say. Psychotic disorientation, for example, can occur with underlying psychiatric problems (such as delirium), hearing and sight deficits, disrupted schedules, poor sleep and appetite, incontinence, pain, unrelated medical complications, or environmental stressors.

For many older patients with problem behaviors, SGAs are worth the risk after other interventions have failed, Dr. Kamholz says. Weighing behavioral against pharmacologic risks is key, Dr. Schneider adds.

“What are the consequences of the behavior or paranoid ideation?” Dr. Schneider asks. “What about when the patient is refusing food? Or when caregivers cannot approach the patient, or the behavior creates a rift between family members so that the patient’s basic needs cannot be met? If psychosocial and environmental interventions haven’t worked, [SGAs] are worth a try.”

Because acute behavior hastens caregiver burnout—a major cause of nursing home admission⁶—appropriate SGA use also can help older patients remain at home, Drs. Schneider, Kamholz, and Verma say.

Practical applications

Drs. Schneider, Verma, and Kamholz agree that SGAs are a short-term intervention for problem behaviors in dementia. Because Alzheimer’s symptoms wax and wane as the disease progresses, patients need to be monitored continually, and medication regimens should be modified as needed and discontinued if possible.

Dr. Verma advises starting risperidone, olanza-pine, or quetiapine at low dosages, titrating slowly, and monitoring the patient carefully (Table).

Dr. Schneider suggests discontinuing the SGA after 12 to 20 weeks in patients who have responded. If behavior worsens after an SGA is discontinued, restart the medication, he says.

“If patients have adverse events with SGAs, do not try to tough it out,” Dr. Schneider adds. “Either adjust medications to eliminate adverse events or change the medication. If patients have been tolerating the medication for, say, 12 weeks, that doesn’t mean adverse reactions cannot develop later, so be ready to make adjustments.”

To guard against medicolegal risk when prescribing SGAs to older patients, Dr. Verma suggests that you clearly document:

• the reason you are prescribing the SGA
• your understanding of the risk/benefit ratio in using SGAs and that, in your clinical judgment, using an SGA in this patient is warranted because the benefits outweigh the risks
• that you considered other medications and the reasons those medications are inappropriate (for example, “I opted against a benzodiazepine because it could be too sedating and could increase the risk of falls and consequent injury”).

Also, get updates from the patient’s primary care physician on the patient’s cardiopulmonary and cerebrovascular health. Finally, provide extensive information about SGAs’ risks to family members, and keep signed documentation that you provided these warnings.

Table

Recommended second-generation antipsychotic dosing for older patients

Related resources

• American Association for Geriatric Psychiatry. AAGP position statement: Principles of care for patients with dementia resulting from Alzheimer disease.www.aagponline.org/prof/position_caredmnalz.asp.

Drug brand names

• Haloperidol • Haldol
• Olanzapine • Zyprexa
• Quetiapine • Seroquel
• Risperidone • Risperdal

Acknowledgment

Peter A. Kelly is senior editor, Current Psychiatry.

Lynn Waltz, a medical writer and editor in Norfolk, VA, helped prepare this article from transcripts of interviews with Drs. Kamholz, Schneider, and Verma.

New findings questioning the value of second-generation antipsychotics (SGAs) for treating acute behaviors in patients with Alzheimer’s disease have raised more questions on when and how to use these agents in the elderly.

The National Institute of Mental Health-sponsored Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer’s disease (CATIE-AD) concluded that SGAs offer no overall advantage over placebo. Although SGAs helped some trial patients, the medications were discontinued for approximately 8 in 10 patients because of intolerable side effects or ineffectiveness.

CATIE-AD’s principal investigator says the findings—published in the October 12 New England Journal of Medicine¹—will guide clinicians in adjusting SGA dosages and durations for older patients with dementia.

But other psychiatrists argue that the study—led by prominent researchers and published in a prestigious medical journal—will deter clinicians from trying SGAs for older patients with dementia-related psychosis, aggression, or agitation.

“These drugs are not FDA-approved for dementia. They may cause diabetes. They cause weight gain. They carry boxed warnings that they could increase risk of stroke and—in patients over age 85—can increase risk of dying,” says Sumer Verma, MD, director of the geriatric psychiatry education program at McLean Hospital (Belmont, MA). “Doctors already were reluctant to use SGAs, and now these researchers publish this study in one of the country’s most respected journals and make an unqualified statement to the effect that [SGAs] are no better than placebo. How many clinicians will be comfortable prescribing them?”

Box

‘Discouraging’ discontinuation

CATIE-AD—a double-blind, multicenter, randomized trial (Box)—followed 421 ambulatory outpatients with Alzheimer’s disease and psychosis, aggression, or agitation. Patients received the SGAs olanzapine (mean dosage, 5.5 mg/d), quetiapine (mean 56.5 mg/d), risperidone (mean 1 mg/d), or placebo. Dosages were adjusted as needed.

After 36 weeks, times to discontinuation because of lack of efficacy were longest for olanza-pine and risperidone, but these drugs also had the highest rates of discontinuation because of intolerability (24% and 18%, respectively). Quetiapine’s rate of discontinuation because of intolerability was 16%.

SGAs were stopped because of lack of efficacy or intolerable side effects—such as parkinsonism, extrapyramidal symptoms, sedation, or weight gain—in:

• 63% of treatment and placebo group patients within 12 weeks
• 82% of all patients within 36 weeks.

Lon Schneider, MD, principal investigator for CATIE-AD, acknowledged that the findings could discourage psychiatrists from prescribing SGAs for acute dementia-related behaviors, specifically in patients with Alzheimer’s disease.

But although discontinuation because of intolerability was most prevalent among patients taking risperidone or olanzapine, both SGAs were more effective than placebo for treating problem behaviors in some participants, Dr. Schneider notes. He adds that the patient population and most SGA dosages in CATIE-AD reflected typical geriatric psychiatric practice in the community.

An editorial in the October 12 New England Journal of Medicine² praised CATIE-AD for allowing physicians to titrate and stop SGA regimens as needed while maintaining the double-blind design. Results of fixed-dose trials with prespecified time points are more difficult to apply to clinical practice because the course of Alzheimer’s disease and patients’ ability to tolerate specific drugs change over time.²

“This study can inform clinicians that they should not be prescribing medication and then not following up or maintaining it indefinitely,” says Dr. Schneider, who is professor of psychiatry, neurology and gerontology, University of Southern California, Los Angeles.

‘Black box’ fears?

Dr. Verma, however, reports that many clinicians have been hesitant to prescribe SGAs to older patients since last year—when the FDA ordered that SGAs carry “black box” warnings of a possible increased mortality risk in that population.

“CATIE-AD will intensify clinicians’ fears of litigation by implying that the risks of using SGAs outweigh their benefits, especially when SGAs are reported to be no better than placebo,” Dr. Verma predicts. “A lawyer could say to a clinician, ‘You used an SGA on Mr. Smith despite the risks, and he developed XYZ complication?’ Try to work yourself out of that one.

“A paper like this will be snapped up by pharmacy and therapeutics committees around the country, as well as Medicare, Medicaid, and other insurers,” Dr. Verma adds. “They’ll say, ‘These expensive drugs are no better than placebo. Why bother covering them?’”

Echoing Dr. Verma’s fears, the American Association for Geriatric Psychiatry (AAGP) responded to CATIE-AD by urging regulatory agencies not to overreact to the findings or “prevent physicians from exercising clinical judgment.”³ AAGP also is calling for more research “based on clinical and evidence-based protocols designed to help physicians know when and how to start, continue, and discontinue psychotropics” for older patients.³

Another problem with generalizing the CATIE-AD findings, Dr. Verma says, is that many Alzheimer’s patients are more severely impaired than those who participated in CATIE-AD.

“These are people who cannot be managed,” adds Barbara Kamholz, MD, clinical associate professor, University of Michigan, and staff psychiatrist, VA Medical Center, Ann Arbor. “They can’t get through the day. They can’t eat or use the bathroom properly. You can’t treat their medical problems if you can’t manage grossly abusive or violent behaviors.”

Dr. Schneider, however, notes that the outpatients in CATIE-AD were nearly as symptomatic as patients in nursing homes—as suggested by CATIE-AD patients’ mean Brief Psychiatric Rating Scale and Neuropsychiatric Inventory scores (28 and 37, respectively).

Also, Dr. Schneider says, most trials of SGAs conducted among nursing home patients have not yielded statistically significant results.⁴

‘Informing’ practice

Dr. Schneider warns against drastic interpretation of CATIE-AD, saying the trial should guide clinical practice, not radically alter it. He says he will keep prescribing SGAs for short-term acute treatment of older patients whose behavioral problems do not respond to psychosocial interventions, distraction, redirection, environmental manipulation, or other treatments.

“I’m not sure this study has changed my use of [SGAs],” Dr. Schneider says. “What it has done is better inform my considerations in prescribing. But I use [SGAs] in patients with significant behavioral problems—and especially with delusions, paranoia and aggression—who can’t be otherwise treated.”

Studies show that despite their risks, SGAs:

• are associated with one-tenth the risk of tardive dyskinesia compared with first-generation antipsychotics (FGAs) such as haloperidol⁵
• are less likely to cause extrapyramidal symptoms than FGAs.⁶

Dr. Verma notes that the cardiac, cerebrovascular, and cardiopulmonary side effects described in the “black box” warnings on SGAs are prevalent conditions in the elderly, independent of medication.

“Despite the side effects, 20% to 30% of patients [in CATIE-AD] continued to take [SGAs] for the entire study,”

Dr. Verma adds. “[SGAs] are not perfect drugs, but they’re the best we’ve got right now and better than what we had.”

Dr. Schneider acknowledges that no evidence supports use of other drug classes to treat problem behaviors in the elderly. “Antidepressants have their own adverse effects, and you wouldn’t expect them to work for delusions or aggression. And benzodiazepines are strongly associated with falling and oversedation.”

Dr. Kamholz fears that some psychiatrists might eschew SGAs in older patients and prescribe another type of medication that carries a greater side-effect risk.

“If they’re not using [SGAs], they might be using something more dangerous,” Dr. Kamholz says. “For example, haloperidol is an old standby, but very few studies address its global effects. So we’re groping around in the dark. I’ve also seen some bad deliriums caused by benzodiazepines.”

When to prescribe SGAs

At what point does the need to manage psychosis, aggression, or agitation in Alzheimer’s disease outweigh SGAs’ risks?

“Frankly, I’d rather not use medications unless I have to—and then only enough to preserve function while treating the behavioral disturbance,” Dr. Verma says. “I don’t want to anesthetize these patients. I just want to maintain their function, dignity, and quality of life.”

Seeking other causes of acute behaviors is essential before prescribing an SGA, Drs. Verma and Schneider say. Psychotic disorientation, for example, can occur with underlying psychiatric problems (such as delirium), hearing and sight deficits, disrupted schedules, poor sleep and appetite, incontinence, pain, unrelated medical complications, or environmental stressors.

For many older patients with problem behaviors, SGAs are worth the risk after other interventions have failed, Dr. Kamholz says. Weighing behavioral against pharmacologic risks is key, Dr. Schneider adds.

“What are the consequences of the behavior or paranoid ideation?” Dr. Schneider asks. “What about when the patient is refusing food? Or when caregivers cannot approach the patient, or the behavior creates a rift between family members so that the patient’s basic needs cannot be met? If psychosocial and environmental interventions haven’t worked, [SGAs] are worth a try.”

Because acute behavior hastens caregiver burnout—a major cause of nursing home admission⁶—appropriate SGA use also can help older patients remain at home, Drs. Schneider, Kamholz, and Verma say.

Practical applications

Drs. Schneider, Verma, and Kamholz agree that SGAs are a short-term intervention for problem behaviors in dementia. Because Alzheimer’s symptoms wax and wane as the disease progresses, patients need to be monitored continually, and medication regimens should be modified as needed and discontinued if possible.

Dr. Verma advises starting risperidone, olanza-pine, or quetiapine at low dosages, titrating slowly, and monitoring the patient carefully (Table).

Dr. Schneider suggests discontinuing the SGA after 12 to 20 weeks in patients who have responded. If behavior worsens after an SGA is discontinued, restart the medication, he says.

“If patients have adverse events with SGAs, do not try to tough it out,” Dr. Schneider adds. “Either adjust medications to eliminate adverse events or change the medication. If patients have been tolerating the medication for, say, 12 weeks, that doesn’t mean adverse reactions cannot develop later, so be ready to make adjustments.”

To guard against medicolegal risk when prescribing SGAs to older patients, Dr. Verma suggests that you clearly document:

• the reason you are prescribing the SGA
• your understanding of the risk/benefit ratio in using SGAs and that, in your clinical judgment, using an SGA in this patient is warranted because the benefits outweigh the risks
• that you considered other medications and the reasons those medications are inappropriate (for example, “I opted against a benzodiazepine because it could be too sedating and could increase the risk of falls and consequent injury”).

Also, get updates from the patient’s primary care physician on the patient’s cardiopulmonary and cerebrovascular health. Finally, provide extensive information about SGAs’ risks to family members, and keep signed documentation that you provided these warnings.

Table

Recommended second-generation antipsychotic dosing for older patients

Related resources

• American Association for Geriatric Psychiatry. AAGP position statement: Principles of care for patients with dementia resulting from Alzheimer disease.www.aagponline.org/prof/position_caredmnalz.asp.

Drug brand names

• Haloperidol • Haldol
• Olanzapine • Zyprexa
• Quetiapine • Seroquel
• Risperidone • Risperdal

Acknowledgment

Peter A. Kelly is senior editor, Current Psychiatry.

Lynn Waltz, a medical writer and editor in Norfolk, VA, helped prepare this article from transcripts of interviews with Drs. Kamholz, Schneider, and Verma.

Ms. A experienced an anxiety attack while driving home from work, with cardiac palpitations, tingling of the face, and fear of impending doom. Over the following 3 months she endured a “living hell,” consisting of basal anxiety, intermittent panic attacks, and agoraphobia, with exceptional difficulty even going to the grocery store.

A high-functioning career woman in her 30s, Ms. A also developed insomnia, depressed mood, and intrusive ego-dystonic thoughts. These symptoms emerged 10 years after a subtotal thyroidectomy for hyperthyroidism (Graves’ disease).

Hyperthyroidism’s association with psychiatric-spectrum symptoms is well-recognized (Box 1).^1-4 Hyperthyroid patients are significantly more likely than controls to report feelings of isolation, impaired social functioning, anxiety, and mood disturbances⁵ and are more likely to be hospitalized with an affective disorder.⁶

Other individuals with subclinical or overt biochemical hyperthyroidism self-report above-average mood and lower-than-average anxiety.⁷

Ms. A’s is the first of three cases presented here to help you screen for and identify thyrotoxicosis (thyroid and nonthyroid causes of excessive thyroid hormone). Cases include:

• recurrent Graves’ disease with panic disorder and residual obsessive-compulsive disorder (Ms. A)
• undetected Graves’ hyperthyroidism in a bipolar-like mood syndrome with severe anxiety and cognitive decline (Ms. B)
• occult hyperthyroidism with occult anxiety (Mr. C).

These cases show that even when biochemical euthyroidism is restored, many formerly hyperthyroid patients with severe mood, anxiety, and/or cognitive symptoms continue to have significant residual symptoms that require ongoing psychiatric attention.⁶

Ms. A: Anxiety and thyrotoxicosis

Ms. A was greatly troubled by her intrusive ego-dystonic thoughts, which involved:

• violence to her beloved young children (for example, what would happen if someone started shooting her children with a gun)
• bizarre sexual ideations (for example, during dinner with an elderly woman she could not stop imagining her naked)
• paranoid ideations (for example, “Is my husband poisoning me?”).

Without thyroid supplementation or replacement, she became biochemically euthyroid, with TSH 1.47 mIU/L and triiodothyronine (T3) and T4 in mid-normal range. Her panic anxiety resolved and her mood and sleep normalized, but the bizarre thoughts remained. The endocrinologist referred her to a psychiatrist, who diagnosed obsessive-compulsive disorder. Ms. A was effectively treated with fluvoxamine, 125 mg/d.

Discussion. Many patients with hyperthyroidism suffer from anxiety syndromes,^8-10 including generalized anxiety disorder and social phobia (Table 1). “Nervousness” (including “feelings of apprehension and inability to concentrate”) is almost invariably present in the thyrotoxicosis of Graves’ disease.¹¹

Hyperthyroidism-related anxiety syndromes are typically complicated by major depression and cognitive decline, such as in memory and attention.⁹ Thus, a pituitary-thyroid workup is an important step in the psychiatric evaluation of any patient with clinically significant anxiety (Box 2).³

Box 1

CNS hypersensitivity to low-grade hyperthyroidism can manifest as an anxiety disorder before other Graves’ disease stigmata emerge. Panic disorder, for example, has been reported to precede Graves’ hyperthyroidism by 4 to 5 years in some cases,¹² although how frequently this occurs is not known. Therefore, re-evaluate the thyroid status of any patient with severe anxiety who is biochemically euthyroid. Check yearly, for example, if anxiety is incompletely resolved.

Table 1

Psychiatric symptoms seen with hyperthyroidism

Causes of hyperthyroidism

Approximately 20 causes of thyrotoxicosis and hyperthyroxinemia have been characterized (see Related resources).^11,13-15 The most common causes of hyperthyroidism are Graves’ disease, toxic multinodular goiter, and toxic thyroid adenoma. Another is thyroiditis, such as from lithium or iodine excess (such as from the cardiac drug amiodarone). A TSH-secreting pituitary adenoma is a rare cause of hyperthyroidism.¹⁶

A drug-induced thyrotoxic state can be seen with excess administration of exogenous thyroid hormone. This condition usually occurs inadvertently but is sometimes intentional, as in factitious disorder or malingering.

Graves’ disease is an autoimmune disorder that occurs when antibodies (thyroid-stimulating hormone immunoglobulins) stimulate thyroid TSH receptors, increasing thyroid hormone synthesis and secretion. Graves’ disease—seen in 60% to 85% of patients with thyrotoxicosis—is the most common cause of hyperthyroidism.¹⁵

Patients most often are women of childbearing years to middle age. Exophthalmos and other eye changes are common, along with diffuse goiter. Encephalopathy can be seen in Graves’ disease and Hashimoto’s thyroiditis because the brain can become an antibody target in autoimmune disorders.

Toxic multinodular goiter consists of autonomously functioning, circumscribed thyroid nodules with an enlarged (goitrous) thyroid, that typically emerge at length from simple (nontoxic) goiter—characterized by enlarged thyroid but normal thyroid-related biochemistry. Onset is typically later in life than Graves’ disease.^11,17

Thyrotoxicosis is often relatively mild in toxic multinodular goiter, with marginal elevations in T4 and/or T3. Unlike in Graves’ disease, ophthalmologic changes are unusual. Tachycardia and weakness are common (Table 2).

Table 2

Nonpsychiatric symptoms seen with hyperthyroidism

Adenomas. Toxic thyroid adenoma is a hyperfunctioning (“toxic”) benign tumor of the thyroid follicular cell. A TSH-secreting pituitary adenoma is a rare cause of hyperthyroidism.¹⁶

Thyroid storm is a rare, life-threatening thyrotoxicosis, usually seen in medical or surgical patients. Symptoms include fever, tachycardia, hypotension, irritability and restlessness, nausea and vomiting, delirium, and possibly coma.

Psychiatrists rarely see these cases, but propranolol (40 mg initial dose), fluids, and swift transport to an emergency room or critical care unit are indicated. Antithyroid agents and glucocorticoids are the usual treatment.

Thyrotoxic symptoms from thyroid hormone therapy. Thyroid hormone has been used in psychiatric patients as an antidepressant supplement,¹⁸ with therapeutic benefit reported to range from highly valuable¹⁹ to modestly helpful or no effect.²⁰ In some patients thyroid hormone causes thyrotoxic symptoms such as tachycardia, gross tremulousness, restlessness, anxiety, inability to sleep, and impaired concentration.

Patients newly diagnosed with hypothyroidism can be exquisitely sensitive to exogenous thyroid hormone and develop acute thyrotoxic symptoms. When this occurs, a more measured titration of thyroid dose is indicated, rather than discontinuing hormone therapy. For example, patients whose optimal maintenance levothyroxine dosage proves to be >100 mcg/d might do better by first adapting to 75 mcg/d.

Thyroid hormone replacement can increase demand on the adrenal glands of chronically hypothyroid patients. For those who develop thyrotoxic-like symptoms, a pulse of glucocorticoids—such as a single 20-mg dose of prednisone (2 to 3 times the typical daily glucocorticoid maintenance requirement)—is sometimes very helpful. Severe eye pain and periorbital edema has been reported to respond to prednisone doses of 120 mg/d.¹³

Box 2

Ms. B: Hyperthyroidism and mood

Ms. B, age 35, an energetic clerical worker and fitness devotee, developed severe insomnia. She slept no more than 1 hour per night, with irritability, verbal explosiveness, “hot flashes,” and depressed mood. “Everything pisses me off violently,” she said.

She consulted a psychiatrist and was diagnosed with major depression. Over a period of years, she was serially prescribed selective serotonin reuptake inhibitors, serotonin/norepinephrine reuptake inhibitors, and older-generation sedating agents including trazodone and amitriptyline. She tolerated none of these because of side effects, including dysphoric hyperarousal and cognitive disruption.

“They all made me stupid,” she complained.

Zolpidem, 20 mg at night, helped temporarily as a hypnotic, but insomnia recurred within weeks. Diazepam was effective at high dosages but also dulled her cognition. The psychiatrist did not suspect a thyroid abnormality and did not perform a pituitary-thyroid laboratory evaluation.

Ms. B consulted a gynecologist, who prescribed estrogen for borderline low estradiol levels and with the hope that Ms. B’s symptoms represented early menopause. This partially ameliorated her irritability, possibly because estradiol binding of circulating T4 reduced free thyroid hormone levels.

Ms. B tried to continue working and exercising, but within 4 years her symptoms progressed to severe depression with frequent crying spells, feelings of general malaise, excessive sweating, occasional panic attacks, fatigue, sleepiness, deteriorating vision, and cognitive impairment. She struggled to read printed words and eventually took sick leave while consulting with physicians.

Finally, a routine thyroid screen before minor surgery revealed an undetectable TSH concentration. Further testing showed elevated thyroxine consistent with thyrotoxicosis. Graves’ disease was diagnosed, and euthyroidism was established with antithyroid medication.

Residual mood and anxiety symptoms persisted 1 year after euthyroidism was restored, and Ms. B sought psychiatric consultation.

Discussion. Hyperthyroidism can trigger or present as a hypomania or manic-like state, characterized by increased energy, hyperactivity, racing thoughts, hair-trigger verbal explosiveness, and decreased need for sleep.

Hypertalkativeness is common, even without pressured speech, as is irritability. Mood may be elevated, depressed, mixed, or cycling. A hyperthyroidism-related mixed syndrome of depression and hypomania can be confounding.

Mr. C: Occult hyperthyroidism

Mr. C, age 26, was apparently healthy when he was admitted into a neuroendocrine research protocol as a volunteer. His job performance was excellent, and his interactions with others were good; he was in good general health and taking no medication.

Formal psychiatric screening found no history of psychiatric disorders in Mr. C nor his family. His mental status was within normal limits. Physical exam revealed no significant abnormality. He was afebrile, normotensive, and had a resting pulse of 81 bpm.

His neurologic status was unremarkable, and laboratory screening tests showed normal CBC, liver and renal profiles, glucose, platelets and clotting times. Tests during the study, however, showed frankly elevated T4, free thyroxine (FT4), and T3 concentrations, along with undetectable TSH. Mr. C was informed of these results and referred to an endocrinologist.

Graves’ disease was diagnosed, and Mr. C received partial thyroid ablation therapy. He later reported that he had never felt better. In retrospect, he realized he had been anxious before he was treated for hyperthyroidism because he felt much more relaxed and able to concentrate after treatment.

Discussion. Subjective well-being in a patient with occult biochemical thyrotoxicosis can be misleading. Mr. C was much less anxious and able to concentrate after his return to euthyroidism.

Treatment

Refer your hyperthyroid patients to an endocrinologist for further workup and, in most cases, management. Hyperthyroidism is usually easy to treat using a form of ablation (antithyroid drugs, radioactive iodine, or partial thyroidectomy).

Remain involved in the patient’s care when psychiatric symptoms are prominent, however, as they are likely to persist even after thyrotoxicosis is corrected.⁶ Reasonable interventions include:

• control of acute thyrotoxic symptoms such as palpitations and tremulousness with propranolol, 20 to 40 mg as needed, or a 20-mg bolus of prednisone (especially if thyroiditis is present)
• address mood cycling, depression, edginess, anxiety, lability, insomnia, and/or irritability with lithium³
• oversee smoking cessation in patients with Graves’ disease (smoking exacerbates the autoimmune pathology).

Address and correct hyperthyroidism that is artifactual (caused by overuse or secret use by a patient) or iatrogenic (related to excessive prescribed hormone dosages).

Subclinical hyperthyroidism can be transient and resolve without treatment. Lithium can be helpful when a mood disorder coexists with sub clinical hyperthyroidism. Start with 300 to 600 mg every evening with dinner. If the mood disorder is mild, even as little as 300 to 450 mg of lithium may elevate a depressed mood and remove edginess and irritability.

Lithium is antithyroid, decreases thyroid hormone output, and increases serum TSH within 24 hours of initiation, but it can provoke autoimmune hyperthyroidism in some individuals.²¹

Related resources

• For comprehensive tables of hyperthyroidism’s causes, refer to Pearce EN. Diagnosis and management of thyrotoxicosis. BMJ 2006;332:1369-73, or Lazarus JH. Hyperthyroidism. Lancet 1997;349:339-43.
• Geracioti TD Jr. Identifying hypothyroidism’s psychiatric presentations. Current Psychiatry 2006;5(11):98-117.
• Bauer M, Heinz A, Whybrow PC. Thyroid hormones, serotonin and mood: of synergy and significance in the adult brain. Molecular Psychiatry 2002;7:140-56.

Drug brand names

• Fluvoxamine • Luvox
• Lithium • Lithobid, others
• Levothyroxine • Synthroid, others
• Prednisone • Various brands
• Propranolol • Inderal
• Zolpidem • Ambien

Disclosures

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

Ms. A experienced an anxiety attack while driving home from work, with cardiac palpitations, tingling of the face, and fear of impending doom. Over the following 3 months she endured a “living hell,” consisting of basal anxiety, intermittent panic attacks, and agoraphobia, with exceptional difficulty even going to the grocery store.

A high-functioning career woman in her 30s, Ms. A also developed insomnia, depressed mood, and intrusive ego-dystonic thoughts. These symptoms emerged 10 years after a subtotal thyroidectomy for hyperthyroidism (Graves’ disease).

Hyperthyroidism’s association with psychiatric-spectrum symptoms is well-recognized (Box 1).^1-4 Hyperthyroid patients are significantly more likely than controls to report feelings of isolation, impaired social functioning, anxiety, and mood disturbances⁵ and are more likely to be hospitalized with an affective disorder.⁶

Other individuals with subclinical or overt biochemical hyperthyroidism self-report above-average mood and lower-than-average anxiety.⁷

Ms. A’s is the first of three cases presented here to help you screen for and identify thyrotoxicosis (thyroid and nonthyroid causes of excessive thyroid hormone). Cases include:

• recurrent Graves’ disease with panic disorder and residual obsessive-compulsive disorder (Ms. A)
• undetected Graves’ hyperthyroidism in a bipolar-like mood syndrome with severe anxiety and cognitive decline (Ms. B)
• occult hyperthyroidism with occult anxiety (Mr. C).

These cases show that even when biochemical euthyroidism is restored, many formerly hyperthyroid patients with severe mood, anxiety, and/or cognitive symptoms continue to have significant residual symptoms that require ongoing psychiatric attention.⁶

Ms. A: Anxiety and thyrotoxicosis

Ms. A was greatly troubled by her intrusive ego-dystonic thoughts, which involved:

• violence to her beloved young children (for example, what would happen if someone started shooting her children with a gun)
• bizarre sexual ideations (for example, during dinner with an elderly woman she could not stop imagining her naked)
• paranoid ideations (for example, “Is my husband poisoning me?”).

Without thyroid supplementation or replacement, she became biochemically euthyroid, with TSH 1.47 mIU/L and triiodothyronine (T3) and T4 in mid-normal range. Her panic anxiety resolved and her mood and sleep normalized, but the bizarre thoughts remained. The endocrinologist referred her to a psychiatrist, who diagnosed obsessive-compulsive disorder. Ms. A was effectively treated with fluvoxamine, 125 mg/d.

Discussion. Many patients with hyperthyroidism suffer from anxiety syndromes,^8-10 including generalized anxiety disorder and social phobia (Table 1). “Nervousness” (including “feelings of apprehension and inability to concentrate”) is almost invariably present in the thyrotoxicosis of Graves’ disease.¹¹

Hyperthyroidism-related anxiety syndromes are typically complicated by major depression and cognitive decline, such as in memory and attention.⁹ Thus, a pituitary-thyroid workup is an important step in the psychiatric evaluation of any patient with clinically significant anxiety (Box 2).³

Box 1

CNS hypersensitivity to low-grade hyperthyroidism can manifest as an anxiety disorder before other Graves’ disease stigmata emerge. Panic disorder, for example, has been reported to precede Graves’ hyperthyroidism by 4 to 5 years in some cases,¹² although how frequently this occurs is not known. Therefore, re-evaluate the thyroid status of any patient with severe anxiety who is biochemically euthyroid. Check yearly, for example, if anxiety is incompletely resolved.

Table 1

Psychiatric symptoms seen with hyperthyroidism

Causes of hyperthyroidism

Approximately 20 causes of thyrotoxicosis and hyperthyroxinemia have been characterized (see Related resources).^11,13-15 The most common causes of hyperthyroidism are Graves’ disease, toxic multinodular goiter, and toxic thyroid adenoma. Another is thyroiditis, such as from lithium or iodine excess (such as from the cardiac drug amiodarone). A TSH-secreting pituitary adenoma is a rare cause of hyperthyroidism.¹⁶

A drug-induced thyrotoxic state can be seen with excess administration of exogenous thyroid hormone. This condition usually occurs inadvertently but is sometimes intentional, as in factitious disorder or malingering.

Graves’ disease is an autoimmune disorder that occurs when antibodies (thyroid-stimulating hormone immunoglobulins) stimulate thyroid TSH receptors, increasing thyroid hormone synthesis and secretion. Graves’ disease—seen in 60% to 85% of patients with thyrotoxicosis—is the most common cause of hyperthyroidism.¹⁵

Patients most often are women of childbearing years to middle age. Exophthalmos and other eye changes are common, along with diffuse goiter. Encephalopathy can be seen in Graves’ disease and Hashimoto’s thyroiditis because the brain can become an antibody target in autoimmune disorders.

Toxic multinodular goiter consists of autonomously functioning, circumscribed thyroid nodules with an enlarged (goitrous) thyroid, that typically emerge at length from simple (nontoxic) goiter—characterized by enlarged thyroid but normal thyroid-related biochemistry. Onset is typically later in life than Graves’ disease.^11,17

Thyrotoxicosis is often relatively mild in toxic multinodular goiter, with marginal elevations in T4 and/or T3. Unlike in Graves’ disease, ophthalmologic changes are unusual. Tachycardia and weakness are common (Table 2).

Table 2

Nonpsychiatric symptoms seen with hyperthyroidism

Adenomas. Toxic thyroid adenoma is a hyperfunctioning (“toxic”) benign tumor of the thyroid follicular cell. A TSH-secreting pituitary adenoma is a rare cause of hyperthyroidism.¹⁶

Thyroid storm is a rare, life-threatening thyrotoxicosis, usually seen in medical or surgical patients. Symptoms include fever, tachycardia, hypotension, irritability and restlessness, nausea and vomiting, delirium, and possibly coma.

Psychiatrists rarely see these cases, but propranolol (40 mg initial dose), fluids, and swift transport to an emergency room or critical care unit are indicated. Antithyroid agents and glucocorticoids are the usual treatment.

Thyrotoxic symptoms from thyroid hormone therapy. Thyroid hormone has been used in psychiatric patients as an antidepressant supplement,¹⁸ with therapeutic benefit reported to range from highly valuable¹⁹ to modestly helpful or no effect.²⁰ In some patients thyroid hormone causes thyrotoxic symptoms such as tachycardia, gross tremulousness, restlessness, anxiety, inability to sleep, and impaired concentration.

Patients newly diagnosed with hypothyroidism can be exquisitely sensitive to exogenous thyroid hormone and develop acute thyrotoxic symptoms. When this occurs, a more measured titration of thyroid dose is indicated, rather than discontinuing hormone therapy. For example, patients whose optimal maintenance levothyroxine dosage proves to be >100 mcg/d might do better by first adapting to 75 mcg/d.

Thyroid hormone replacement can increase demand on the adrenal glands of chronically hypothyroid patients. For those who develop thyrotoxic-like symptoms, a pulse of glucocorticoids—such as a single 20-mg dose of prednisone (2 to 3 times the typical daily glucocorticoid maintenance requirement)—is sometimes very helpful. Severe eye pain and periorbital edema has been reported to respond to prednisone doses of 120 mg/d.¹³

Box 2

Ms. B: Hyperthyroidism and mood

Ms. B, age 35, an energetic clerical worker and fitness devotee, developed severe insomnia. She slept no more than 1 hour per night, with irritability, verbal explosiveness, “hot flashes,” and depressed mood. “Everything pisses me off violently,” she said.

She consulted a psychiatrist and was diagnosed with major depression. Over a period of years, she was serially prescribed selective serotonin reuptake inhibitors, serotonin/norepinephrine reuptake inhibitors, and older-generation sedating agents including trazodone and amitriptyline. She tolerated none of these because of side effects, including dysphoric hyperarousal and cognitive disruption.

“They all made me stupid,” she complained.

Zolpidem, 20 mg at night, helped temporarily as a hypnotic, but insomnia recurred within weeks. Diazepam was effective at high dosages but also dulled her cognition. The psychiatrist did not suspect a thyroid abnormality and did not perform a pituitary-thyroid laboratory evaluation.

Ms. B consulted a gynecologist, who prescribed estrogen for borderline low estradiol levels and with the hope that Ms. B’s symptoms represented early menopause. This partially ameliorated her irritability, possibly because estradiol binding of circulating T4 reduced free thyroid hormone levels.

Ms. B tried to continue working and exercising, but within 4 years her symptoms progressed to severe depression with frequent crying spells, feelings of general malaise, excessive sweating, occasional panic attacks, fatigue, sleepiness, deteriorating vision, and cognitive impairment. She struggled to read printed words and eventually took sick leave while consulting with physicians.

Finally, a routine thyroid screen before minor surgery revealed an undetectable TSH concentration. Further testing showed elevated thyroxine consistent with thyrotoxicosis. Graves’ disease was diagnosed, and euthyroidism was established with antithyroid medication.

Residual mood and anxiety symptoms persisted 1 year after euthyroidism was restored, and Ms. B sought psychiatric consultation.

Discussion. Hyperthyroidism can trigger or present as a hypomania or manic-like state, characterized by increased energy, hyperactivity, racing thoughts, hair-trigger verbal explosiveness, and decreased need for sleep.

Hypertalkativeness is common, even without pressured speech, as is irritability. Mood may be elevated, depressed, mixed, or cycling. A hyperthyroidism-related mixed syndrome of depression and hypomania can be confounding.

Mr. C: Occult hyperthyroidism

Mr. C, age 26, was apparently healthy when he was admitted into a neuroendocrine research protocol as a volunteer. His job performance was excellent, and his interactions with others were good; he was in good general health and taking no medication.

Formal psychiatric screening found no history of psychiatric disorders in Mr. C nor his family. His mental status was within normal limits. Physical exam revealed no significant abnormality. He was afebrile, normotensive, and had a resting pulse of 81 bpm.

His neurologic status was unremarkable, and laboratory screening tests showed normal CBC, liver and renal profiles, glucose, platelets and clotting times. Tests during the study, however, showed frankly elevated T4, free thyroxine (FT4), and T3 concentrations, along with undetectable TSH. Mr. C was informed of these results and referred to an endocrinologist.

Graves’ disease was diagnosed, and Mr. C received partial thyroid ablation therapy. He later reported that he had never felt better. In retrospect, he realized he had been anxious before he was treated for hyperthyroidism because he felt much more relaxed and able to concentrate after treatment.

Discussion. Subjective well-being in a patient with occult biochemical thyrotoxicosis can be misleading. Mr. C was much less anxious and able to concentrate after his return to euthyroidism.

Treatment

Refer your hyperthyroid patients to an endocrinologist for further workup and, in most cases, management. Hyperthyroidism is usually easy to treat using a form of ablation (antithyroid drugs, radioactive iodine, or partial thyroidectomy).

Remain involved in the patient’s care when psychiatric symptoms are prominent, however, as they are likely to persist even after thyrotoxicosis is corrected.⁶ Reasonable interventions include:

• control of acute thyrotoxic symptoms such as palpitations and tremulousness with propranolol, 20 to 40 mg as needed, or a 20-mg bolus of prednisone (especially if thyroiditis is present)
• address mood cycling, depression, edginess, anxiety, lability, insomnia, and/or irritability with lithium³
• oversee smoking cessation in patients with Graves’ disease (smoking exacerbates the autoimmune pathology).

Address and correct hyperthyroidism that is artifactual (caused by overuse or secret use by a patient) or iatrogenic (related to excessive prescribed hormone dosages).

Subclinical hyperthyroidism can be transient and resolve without treatment. Lithium can be helpful when a mood disorder coexists with sub clinical hyperthyroidism. Start with 300 to 600 mg every evening with dinner. If the mood disorder is mild, even as little as 300 to 450 mg of lithium may elevate a depressed mood and remove edginess and irritability.

Lithium is antithyroid, decreases thyroid hormone output, and increases serum TSH within 24 hours of initiation, but it can provoke autoimmune hyperthyroidism in some individuals.²¹

Related resources

• For comprehensive tables of hyperthyroidism’s causes, refer to Pearce EN. Diagnosis and management of thyrotoxicosis. BMJ 2006;332:1369-73, or Lazarus JH. Hyperthyroidism. Lancet 1997;349:339-43.
• Geracioti TD Jr. Identifying hypothyroidism’s psychiatric presentations. Current Psychiatry 2006;5(11):98-117.
• Bauer M, Heinz A, Whybrow PC. Thyroid hormones, serotonin and mood: of synergy and significance in the adult brain. Molecular Psychiatry 2002;7:140-56.

Drug brand names

• Fluvoxamine • Luvox
• Lithium • Lithobid, others
• Levothyroxine • Synthroid, others
• Prednisone • Various brands
• Propranolol • Inderal
• Zolpidem • Ambien

Disclosures

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

Ms. A experienced an anxiety attack while driving home from work, with cardiac palpitations, tingling of the face, and fear of impending doom. Over the following 3 months she endured a “living hell,” consisting of basal anxiety, intermittent panic attacks, and agoraphobia, with exceptional difficulty even going to the grocery store.

A high-functioning career woman in her 30s, Ms. A also developed insomnia, depressed mood, and intrusive ego-dystonic thoughts. These symptoms emerged 10 years after a subtotal thyroidectomy for hyperthyroidism (Graves’ disease).

Hyperthyroidism’s association with psychiatric-spectrum symptoms is well-recognized (Box 1).^1-4 Hyperthyroid patients are significantly more likely than controls to report feelings of isolation, impaired social functioning, anxiety, and mood disturbances⁵ and are more likely to be hospitalized with an affective disorder.⁶

Other individuals with subclinical or overt biochemical hyperthyroidism self-report above-average mood and lower-than-average anxiety.⁷

Ms. A’s is the first of three cases presented here to help you screen for and identify thyrotoxicosis (thyroid and nonthyroid causes of excessive thyroid hormone). Cases include:

• recurrent Graves’ disease with panic disorder and residual obsessive-compulsive disorder (Ms. A)
• undetected Graves’ hyperthyroidism in a bipolar-like mood syndrome with severe anxiety and cognitive decline (Ms. B)
• occult hyperthyroidism with occult anxiety (Mr. C).

These cases show that even when biochemical euthyroidism is restored, many formerly hyperthyroid patients with severe mood, anxiety, and/or cognitive symptoms continue to have significant residual symptoms that require ongoing psychiatric attention.⁶

Ms. A: Anxiety and thyrotoxicosis

Ms. A was greatly troubled by her intrusive ego-dystonic thoughts, which involved:

• violence to her beloved young children (for example, what would happen if someone started shooting her children with a gun)
• bizarre sexual ideations (for example, during dinner with an elderly woman she could not stop imagining her naked)
• paranoid ideations (for example, “Is my husband poisoning me?”).

Without thyroid supplementation or replacement, she became biochemically euthyroid, with TSH 1.47 mIU/L and triiodothyronine (T3) and T4 in mid-normal range. Her panic anxiety resolved and her mood and sleep normalized, but the bizarre thoughts remained. The endocrinologist referred her to a psychiatrist, who diagnosed obsessive-compulsive disorder. Ms. A was effectively treated with fluvoxamine, 125 mg/d.

Discussion. Many patients with hyperthyroidism suffer from anxiety syndromes,^8-10 including generalized anxiety disorder and social phobia (Table 1). “Nervousness” (including “feelings of apprehension and inability to concentrate”) is almost invariably present in the thyrotoxicosis of Graves’ disease.¹¹

Hyperthyroidism-related anxiety syndromes are typically complicated by major depression and cognitive decline, such as in memory and attention.⁹ Thus, a pituitary-thyroid workup is an important step in the psychiatric evaluation of any patient with clinically significant anxiety (Box 2).³

Box 1

CNS hypersensitivity to low-grade hyperthyroidism can manifest as an anxiety disorder before other Graves’ disease stigmata emerge. Panic disorder, for example, has been reported to precede Graves’ hyperthyroidism by 4 to 5 years in some cases,¹² although how frequently this occurs is not known. Therefore, re-evaluate the thyroid status of any patient with severe anxiety who is biochemically euthyroid. Check yearly, for example, if anxiety is incompletely resolved.

Table 1

Psychiatric symptoms seen with hyperthyroidism

Causes of hyperthyroidism

Approximately 20 causes of thyrotoxicosis and hyperthyroxinemia have been characterized (see Related resources).^11,13-15 The most common causes of hyperthyroidism are Graves’ disease, toxic multinodular goiter, and toxic thyroid adenoma. Another is thyroiditis, such as from lithium or iodine excess (such as from the cardiac drug amiodarone). A TSH-secreting pituitary adenoma is a rare cause of hyperthyroidism.¹⁶

A drug-induced thyrotoxic state can be seen with excess administration of exogenous thyroid hormone. This condition usually occurs inadvertently but is sometimes intentional, as in factitious disorder or malingering.

Graves’ disease is an autoimmune disorder that occurs when antibodies (thyroid-stimulating hormone immunoglobulins) stimulate thyroid TSH receptors, increasing thyroid hormone synthesis and secretion. Graves’ disease—seen in 60% to 85% of patients with thyrotoxicosis—is the most common cause of hyperthyroidism.¹⁵

Patients most often are women of childbearing years to middle age. Exophthalmos and other eye changes are common, along with diffuse goiter. Encephalopathy can be seen in Graves’ disease and Hashimoto’s thyroiditis because the brain can become an antibody target in autoimmune disorders.

Toxic multinodular goiter consists of autonomously functioning, circumscribed thyroid nodules with an enlarged (goitrous) thyroid, that typically emerge at length from simple (nontoxic) goiter—characterized by enlarged thyroid but normal thyroid-related biochemistry. Onset is typically later in life than Graves’ disease.^11,17

Thyrotoxicosis is often relatively mild in toxic multinodular goiter, with marginal elevations in T4 and/or T3. Unlike in Graves’ disease, ophthalmologic changes are unusual. Tachycardia and weakness are common (Table 2).

Table 2

Nonpsychiatric symptoms seen with hyperthyroidism

Adenomas. Toxic thyroid adenoma is a hyperfunctioning (“toxic”) benign tumor of the thyroid follicular cell. A TSH-secreting pituitary adenoma is a rare cause of hyperthyroidism.¹⁶

Thyroid storm is a rare, life-threatening thyrotoxicosis, usually seen in medical or surgical patients. Symptoms include fever, tachycardia, hypotension, irritability and restlessness, nausea and vomiting, delirium, and possibly coma.

Psychiatrists rarely see these cases, but propranolol (40 mg initial dose), fluids, and swift transport to an emergency room or critical care unit are indicated. Antithyroid agents and glucocorticoids are the usual treatment.

Thyrotoxic symptoms from thyroid hormone therapy. Thyroid hormone has been used in psychiatric patients as an antidepressant supplement,¹⁸ with therapeutic benefit reported to range from highly valuable¹⁹ to modestly helpful or no effect.²⁰ In some patients thyroid hormone causes thyrotoxic symptoms such as tachycardia, gross tremulousness, restlessness, anxiety, inability to sleep, and impaired concentration.

Patients newly diagnosed with hypothyroidism can be exquisitely sensitive to exogenous thyroid hormone and develop acute thyrotoxic symptoms. When this occurs, a more measured titration of thyroid dose is indicated, rather than discontinuing hormone therapy. For example, patients whose optimal maintenance levothyroxine dosage proves to be >100 mcg/d might do better by first adapting to 75 mcg/d.

Thyroid hormone replacement can increase demand on the adrenal glands of chronically hypothyroid patients. For those who develop thyrotoxic-like symptoms, a pulse of glucocorticoids—such as a single 20-mg dose of prednisone (2 to 3 times the typical daily glucocorticoid maintenance requirement)—is sometimes very helpful. Severe eye pain and periorbital edema has been reported to respond to prednisone doses of 120 mg/d.¹³

Box 2

Ms. B: Hyperthyroidism and mood

Ms. B, age 35, an energetic clerical worker and fitness devotee, developed severe insomnia. She slept no more than 1 hour per night, with irritability, verbal explosiveness, “hot flashes,” and depressed mood. “Everything pisses me off violently,” she said.

She consulted a psychiatrist and was diagnosed with major depression. Over a period of years, she was serially prescribed selective serotonin reuptake inhibitors, serotonin/norepinephrine reuptake inhibitors, and older-generation sedating agents including trazodone and amitriptyline. She tolerated none of these because of side effects, including dysphoric hyperarousal and cognitive disruption.

“They all made me stupid,” she complained.

Zolpidem, 20 mg at night, helped temporarily as a hypnotic, but insomnia recurred within weeks. Diazepam was effective at high dosages but also dulled her cognition. The psychiatrist did not suspect a thyroid abnormality and did not perform a pituitary-thyroid laboratory evaluation.

Ms. B consulted a gynecologist, who prescribed estrogen for borderline low estradiol levels and with the hope that Ms. B’s symptoms represented early menopause. This partially ameliorated her irritability, possibly because estradiol binding of circulating T4 reduced free thyroid hormone levels.

Ms. B tried to continue working and exercising, but within 4 years her symptoms progressed to severe depression with frequent crying spells, feelings of general malaise, excessive sweating, occasional panic attacks, fatigue, sleepiness, deteriorating vision, and cognitive impairment. She struggled to read printed words and eventually took sick leave while consulting with physicians.

Finally, a routine thyroid screen before minor surgery revealed an undetectable TSH concentration. Further testing showed elevated thyroxine consistent with thyrotoxicosis. Graves’ disease was diagnosed, and euthyroidism was established with antithyroid medication.

Residual mood and anxiety symptoms persisted 1 year after euthyroidism was restored, and Ms. B sought psychiatric consultation.

Discussion. Hyperthyroidism can trigger or present as a hypomania or manic-like state, characterized by increased energy, hyperactivity, racing thoughts, hair-trigger verbal explosiveness, and decreased need for sleep.

Hypertalkativeness is common, even without pressured speech, as is irritability. Mood may be elevated, depressed, mixed, or cycling. A hyperthyroidism-related mixed syndrome of depression and hypomania can be confounding.

Mr. C: Occult hyperthyroidism

Mr. C, age 26, was apparently healthy when he was admitted into a neuroendocrine research protocol as a volunteer. His job performance was excellent, and his interactions with others were good; he was in good general health and taking no medication.

Formal psychiatric screening found no history of psychiatric disorders in Mr. C nor his family. His mental status was within normal limits. Physical exam revealed no significant abnormality. He was afebrile, normotensive, and had a resting pulse of 81 bpm.

His neurologic status was unremarkable, and laboratory screening tests showed normal CBC, liver and renal profiles, glucose, platelets and clotting times. Tests during the study, however, showed frankly elevated T4, free thyroxine (FT4), and T3 concentrations, along with undetectable TSH. Mr. C was informed of these results and referred to an endocrinologist.

Graves’ disease was diagnosed, and Mr. C received partial thyroid ablation therapy. He later reported that he had never felt better. In retrospect, he realized he had been anxious before he was treated for hyperthyroidism because he felt much more relaxed and able to concentrate after treatment.

Discussion. Subjective well-being in a patient with occult biochemical thyrotoxicosis can be misleading. Mr. C was much less anxious and able to concentrate after his return to euthyroidism.

Treatment

Refer your hyperthyroid patients to an endocrinologist for further workup and, in most cases, management. Hyperthyroidism is usually easy to treat using a form of ablation (antithyroid drugs, radioactive iodine, or partial thyroidectomy).

Remain involved in the patient’s care when psychiatric symptoms are prominent, however, as they are likely to persist even after thyrotoxicosis is corrected.⁶ Reasonable interventions include:

• control of acute thyrotoxic symptoms such as palpitations and tremulousness with propranolol, 20 to 40 mg as needed, or a 20-mg bolus of prednisone (especially if thyroiditis is present)
• address mood cycling, depression, edginess, anxiety, lability, insomnia, and/or irritability with lithium³
• oversee smoking cessation in patients with Graves’ disease (smoking exacerbates the autoimmune pathology).

Address and correct hyperthyroidism that is artifactual (caused by overuse or secret use by a patient) or iatrogenic (related to excessive prescribed hormone dosages).

Subclinical hyperthyroidism can be transient and resolve without treatment. Lithium can be helpful when a mood disorder coexists with sub clinical hyperthyroidism. Start with 300 to 600 mg every evening with dinner. If the mood disorder is mild, even as little as 300 to 450 mg of lithium may elevate a depressed mood and remove edginess and irritability.

Lithium is antithyroid, decreases thyroid hormone output, and increases serum TSH within 24 hours of initiation, but it can provoke autoimmune hyperthyroidism in some individuals.²¹

Related resources

• For comprehensive tables of hyperthyroidism’s causes, refer to Pearce EN. Diagnosis and management of thyrotoxicosis. BMJ 2006;332:1369-73, or Lazarus JH. Hyperthyroidism. Lancet 1997;349:339-43.
• Geracioti TD Jr. Identifying hypothyroidism’s psychiatric presentations. Current Psychiatry 2006;5(11):98-117.
• Bauer M, Heinz A, Whybrow PC. Thyroid hormones, serotonin and mood: of synergy and significance in the adult brain. Molecular Psychiatry 2002;7:140-56.

Drug brand names

• Fluvoxamine • Luvox
• Lithium • Lithobid, others
• Levothyroxine • Synthroid, others
• Prednisone • Various brands
• Propranolol • Inderal
• Zolpidem • Ambien

Disclosures

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