We are proud to practice medicine in the modern era: the 21st-century heirs to Hippocrates. Along the way we have abandoned a materia medica of bizarre and unusual therapies like mummy powder and eye of newt. Our pharmaceuticals are lined up in bottles and bags with clearly marked expiration dates. It’s a far cry from the witches in Macbeth, standing around the fire chanting:

Round about the cauldron go;

In the poison’d entrails throw.

Toad, that under cold stone

Days and nights has thirty-one

Swelter’d venom sleeping got,

Boil thou first i’ the charmed pot.

Double, double toil and trouble;

Fire burn and cauldron bubble.

Or have things really changed? We would shake our heads at the remedies of Shakespeare’s son-in-law, Dr. John Hall, who used spider webs, poultry larynx, and animal excreta as part of his materia medica. But wait: Perhaps we should think twice before condemning him. Perhaps we are less different then we think. We just use similar products that have been sanitized.

Some modern medicines retain their strong biotherapeutic flavor. The field of organotherapy led to the extraction of active elements from the glands of mammals and eventually insulin, thyroid extract, growth hormone, testosterone, and adrenaline. The modern forms of these drugs are just a few steps removed from their origins, but somehow don’t strike one as unusual. Read on to see how we use such non-mammalian biotherapeutic exotica as lizard spit, salmon sperm, and leech saliva as part of the most modern pharmaceutical armamentarium.

Lizards

How unlikely would it seem, but all too true, that the newest weapon in the fight against diabetes is derived from lizard spit? The lizards in question are Heloderma horridum and Heloderma suspectum (aka the Mexican beaded lizard and the Gila monster).

This strange tale begins in the Bronx, N.Y., not renowned (aside from the Bronx Zoo) as a home for Sonoran lizards. Cockroaches and rats may be the dominant fauna there. Dr. John Eng, an endocrinologist, was hunting for new hormones. In the venom of the beaded lizard he discovered a vasoactive hormone he named exendin-3. In the venom of the Gila monster he found the less vasoactive exendin-4, which seemed to have an interesting effect on beta cells.

Dr. John Eng eventually patented exendin-4, and now we have the newest drug on the market for the treatment of diabetes. The first of class of incretin mimetics, synthetic exendin-4, is also known as exanatide and marketed as Byetta. Administered as a twice-daily injection, exanatide stimulates beta cells, via a specific receptor, to secrete insulin in a glucose-dependent fashion, suppresses glucagon overproduction, slows gastric emptying, and improves satiety. The net result is that most patients experience improvement of glucose control and weight loss. The most common side effects are nausea, which tends to be moderate, self limited, and a result of hypoglycemia. As with any new drug, side effects may still be determined over time. As of yet there have been no reports of reptilian metamorphosis

Salmon

The sperm of salmon is worth mentioning here as a bridge between diabetes and the treatment of coagulation disorders. An important step in the biotherapy of insulin depended on salmon sperm. Salmon sperm contains protamines, which are small arginine-rich nuclear proteins that stabilize DNA. Salmon sperm was used because it is more easily obtained than some mammalian alternatives.

When we write prescriptions for NPH insulin, how often do we contemplate what those initials represent? The acronym stands for neutral protamine Hagedorn. In 1923 Hans Christian Hagedorn (a Danish physician, 1888-1971) and August Steenberg Krogh (a Nobel-prize winning physiologist, 1874-1949) obtained the rights from Sir Frederick Grant Banting (1891-1941) and Charles Best (1899-1941), who had first isolated insulin, and formed a company called Nordisk Insulinlaboratorium to produce insulin for Scandinavians. Krogh’s wife, Marie, was diabetic.

Ten years later Hagedorn and Jensen discovered that injection of insulin would have a prolonged effect if mixed with protamine-rich salmon sperm. The necessity of a pH of 7 for activation made the handling of insulin difficult. Zinc was added to the mix as a stabilizer. By 1946, an easier-to-use crystallized form was developed, and it was marketed by 1950 as NPH insulin.

When a patient is overdosed with heparin, excessive bleeding can be a problem. Protamine sulfate is a valuable medication used for reversal of heparin. Protamine is a strongly basic substance that combines with the strongly acidic heparin to form a stable complex. The protamine-heparin complex is not an anticoagulant; protamine causes a dissociation of the heparin-antithrombin III complex, resulting in loss of heparin’s anticoagulant activity. Given too quickly it may cause hypotension or anaphylaxis and may cause allergic reactions to patients with fish hypersensitivity.

Leeches

From the anticoagulant effect of salmon sperm, we move to the world of Annelida. More than any other creature, the leech stands out as the epitome of biotherapy. Its name alone, Hirudo medicinalis, emphasizes its medical nature. Used by many ancient societies, the leech reached its zenith in mid-19th century France. Leeches were the fashion, women’s dresses were decorated with faux leeches, and cosmetics were applied to give that “healthy pale look” sometimes attained by being bled with leeches.

In 1833 more than 40 million leeches were imported into France. However, the leech’s days were numbered. The biggest blow was when Pierre Louis made his name as the father of medical statistics by proving leeches led to a worse outcome in treating pneumonia. The death of the leech was the birth of evidence-based medicine.

But all is not lost for the leech lover. The use of the leech as an anticoagulant was recognized in 1884. In its modern chemical form, recombinant leech saliva marketed under names such as lepirudin, is indicated for coronary thrombolysis, unstable angina hemodialysis, heparin-induced thrombocytopenia, and DVT prophylaxis. Recombinant hirudin, a man-made chemical similar to leech saliva, is manufactured in large quantities and is much easier to obtain than “milking” leeches. The mechanism of action is direct inhibition of thrombin. Leeches are making a comeback in the treatment of skin grafts, however. A mechanical leech has also been designed.

The Future

The argument for the protection of our planet’s biodiversity could not be more obvious. A new treatment for diabetes comes from Gila monsters. What novel substances lurk in the ever-shrinking rain forests? Whether from lizard or leech, the day of biotherapy is not yet done. Despite all this, I’m not cornering the market on synthetic eye of newt. TH

Jamie Newman, MD, FACP, is the physician editor of The Hospitalist, consultant, Hospital Internal Medicine, and assistant professor of internal medicine and medical history, Mayo Clinic College of Medicine, Rochester, Minn.

We are proud to practice medicine in the modern era: the 21st-century heirs to Hippocrates. Along the way we have abandoned a materia medica of bizarre and unusual therapies like mummy powder and eye of newt. Our pharmaceuticals are lined up in bottles and bags with clearly marked expiration dates. It’s a far cry from the witches in Macbeth, standing around the fire chanting:

Round about the cauldron go;

In the poison’d entrails throw.

Toad, that under cold stone

Days and nights has thirty-one

Swelter’d venom sleeping got,

Boil thou first i’ the charmed pot.

Double, double toil and trouble;

Fire burn and cauldron bubble.

Or have things really changed? We would shake our heads at the remedies of Shakespeare’s son-in-law, Dr. John Hall, who used spider webs, poultry larynx, and animal excreta as part of his materia medica. But wait: Perhaps we should think twice before condemning him. Perhaps we are less different then we think. We just use similar products that have been sanitized.

Some modern medicines retain their strong biotherapeutic flavor. The field of organotherapy led to the extraction of active elements from the glands of mammals and eventually insulin, thyroid extract, growth hormone, testosterone, and adrenaline. The modern forms of these drugs are just a few steps removed from their origins, but somehow don’t strike one as unusual. Read on to see how we use such non-mammalian biotherapeutic exotica as lizard spit, salmon sperm, and leech saliva as part of the most modern pharmaceutical armamentarium.

Lizards

How unlikely would it seem, but all too true, that the newest weapon in the fight against diabetes is derived from lizard spit? The lizards in question are Heloderma horridum and Heloderma suspectum (aka the Mexican beaded lizard and the Gila monster).

This strange tale begins in the Bronx, N.Y., not renowned (aside from the Bronx Zoo) as a home for Sonoran lizards. Cockroaches and rats may be the dominant fauna there. Dr. John Eng, an endocrinologist, was hunting for new hormones. In the venom of the beaded lizard he discovered a vasoactive hormone he named exendin-3. In the venom of the Gila monster he found the less vasoactive exendin-4, which seemed to have an interesting effect on beta cells.

Dr. John Eng eventually patented exendin-4, and now we have the newest drug on the market for the treatment of diabetes. The first of class of incretin mimetics, synthetic exendin-4, is also known as exanatide and marketed as Byetta. Administered as a twice-daily injection, exanatide stimulates beta cells, via a specific receptor, to secrete insulin in a glucose-dependent fashion, suppresses glucagon overproduction, slows gastric emptying, and improves satiety. The net result is that most patients experience improvement of glucose control and weight loss. The most common side effects are nausea, which tends to be moderate, self limited, and a result of hypoglycemia. As with any new drug, side effects may still be determined over time. As of yet there have been no reports of reptilian metamorphosis

Salmon

The sperm of salmon is worth mentioning here as a bridge between diabetes and the treatment of coagulation disorders. An important step in the biotherapy of insulin depended on salmon sperm. Salmon sperm contains protamines, which are small arginine-rich nuclear proteins that stabilize DNA. Salmon sperm was used because it is more easily obtained than some mammalian alternatives.

When we write prescriptions for NPH insulin, how often do we contemplate what those initials represent? The acronym stands for neutral protamine Hagedorn. In 1923 Hans Christian Hagedorn (a Danish physician, 1888-1971) and August Steenberg Krogh (a Nobel-prize winning physiologist, 1874-1949) obtained the rights from Sir Frederick Grant Banting (1891-1941) and Charles Best (1899-1941), who had first isolated insulin, and formed a company called Nordisk Insulinlaboratorium to produce insulin for Scandinavians. Krogh’s wife, Marie, was diabetic.

Ten years later Hagedorn and Jensen discovered that injection of insulin would have a prolonged effect if mixed with protamine-rich salmon sperm. The necessity of a pH of 7 for activation made the handling of insulin difficult. Zinc was added to the mix as a stabilizer. By 1946, an easier-to-use crystallized form was developed, and it was marketed by 1950 as NPH insulin.

When a patient is overdosed with heparin, excessive bleeding can be a problem. Protamine sulfate is a valuable medication used for reversal of heparin. Protamine is a strongly basic substance that combines with the strongly acidic heparin to form a stable complex. The protamine-heparin complex is not an anticoagulant; protamine causes a dissociation of the heparin-antithrombin III complex, resulting in loss of heparin’s anticoagulant activity. Given too quickly it may cause hypotension or anaphylaxis and may cause allergic reactions to patients with fish hypersensitivity.

Leeches

From the anticoagulant effect of salmon sperm, we move to the world of Annelida. More than any other creature, the leech stands out as the epitome of biotherapy. Its name alone, Hirudo medicinalis, emphasizes its medical nature. Used by many ancient societies, the leech reached its zenith in mid-19th century France. Leeches were the fashion, women’s dresses were decorated with faux leeches, and cosmetics were applied to give that “healthy pale look” sometimes attained by being bled with leeches.

In 1833 more than 40 million leeches were imported into France. However, the leech’s days were numbered. The biggest blow was when Pierre Louis made his name as the father of medical statistics by proving leeches led to a worse outcome in treating pneumonia. The death of the leech was the birth of evidence-based medicine.

But all is not lost for the leech lover. The use of the leech as an anticoagulant was recognized in 1884. In its modern chemical form, recombinant leech saliva marketed under names such as lepirudin, is indicated for coronary thrombolysis, unstable angina hemodialysis, heparin-induced thrombocytopenia, and DVT prophylaxis. Recombinant hirudin, a man-made chemical similar to leech saliva, is manufactured in large quantities and is much easier to obtain than “milking” leeches. The mechanism of action is direct inhibition of thrombin. Leeches are making a comeback in the treatment of skin grafts, however. A mechanical leech has also been designed.

The Future

The argument for the protection of our planet’s biodiversity could not be more obvious. A new treatment for diabetes comes from Gila monsters. What novel substances lurk in the ever-shrinking rain forests? Whether from lizard or leech, the day of biotherapy is not yet done. Despite all this, I’m not cornering the market on synthetic eye of newt. TH

Jamie Newman, MD, FACP, is the physician editor of The Hospitalist, consultant, Hospital Internal Medicine, and assistant professor of internal medicine and medical history, Mayo Clinic College of Medicine, Rochester, Minn.

We are proud to practice medicine in the modern era: the 21st-century heirs to Hippocrates. Along the way we have abandoned a materia medica of bizarre and unusual therapies like mummy powder and eye of newt. Our pharmaceuticals are lined up in bottles and bags with clearly marked expiration dates. It’s a far cry from the witches in Macbeth, standing around the fire chanting:

Round about the cauldron go;

In the poison’d entrails throw.

Toad, that under cold stone

Days and nights has thirty-one

Swelter’d venom sleeping got,

Boil thou first i’ the charmed pot.

Double, double toil and trouble;

Fire burn and cauldron bubble.

Or have things really changed? We would shake our heads at the remedies of Shakespeare’s son-in-law, Dr. John Hall, who used spider webs, poultry larynx, and animal excreta as part of his materia medica. But wait: Perhaps we should think twice before condemning him. Perhaps we are less different then we think. We just use similar products that have been sanitized.

Some modern medicines retain their strong biotherapeutic flavor. The field of organotherapy led to the extraction of active elements from the glands of mammals and eventually insulin, thyroid extract, growth hormone, testosterone, and adrenaline. The modern forms of these drugs are just a few steps removed from their origins, but somehow don’t strike one as unusual. Read on to see how we use such non-mammalian biotherapeutic exotica as lizard spit, salmon sperm, and leech saliva as part of the most modern pharmaceutical armamentarium.

Lizards

How unlikely would it seem, but all too true, that the newest weapon in the fight against diabetes is derived from lizard spit? The lizards in question are Heloderma horridum and Heloderma suspectum (aka the Mexican beaded lizard and the Gila monster).

This strange tale begins in the Bronx, N.Y., not renowned (aside from the Bronx Zoo) as a home for Sonoran lizards. Cockroaches and rats may be the dominant fauna there. Dr. John Eng, an endocrinologist, was hunting for new hormones. In the venom of the beaded lizard he discovered a vasoactive hormone he named exendin-3. In the venom of the Gila monster he found the less vasoactive exendin-4, which seemed to have an interesting effect on beta cells.

Dr. John Eng eventually patented exendin-4, and now we have the newest drug on the market for the treatment of diabetes. The first of class of incretin mimetics, synthetic exendin-4, is also known as exanatide and marketed as Byetta. Administered as a twice-daily injection, exanatide stimulates beta cells, via a specific receptor, to secrete insulin in a glucose-dependent fashion, suppresses glucagon overproduction, slows gastric emptying, and improves satiety. The net result is that most patients experience improvement of glucose control and weight loss. The most common side effects are nausea, which tends to be moderate, self limited, and a result of hypoglycemia. As with any new drug, side effects may still be determined over time. As of yet there have been no reports of reptilian metamorphosis

Salmon

The sperm of salmon is worth mentioning here as a bridge between diabetes and the treatment of coagulation disorders. An important step in the biotherapy of insulin depended on salmon sperm. Salmon sperm contains protamines, which are small arginine-rich nuclear proteins that stabilize DNA. Salmon sperm was used because it is more easily obtained than some mammalian alternatives.

When we write prescriptions for NPH insulin, how often do we contemplate what those initials represent? The acronym stands for neutral protamine Hagedorn. In 1923 Hans Christian Hagedorn (a Danish physician, 1888-1971) and August Steenberg Krogh (a Nobel-prize winning physiologist, 1874-1949) obtained the rights from Sir Frederick Grant Banting (1891-1941) and Charles Best (1899-1941), who had first isolated insulin, and formed a company called Nordisk Insulinlaboratorium to produce insulin for Scandinavians. Krogh’s wife, Marie, was diabetic.

Ten years later Hagedorn and Jensen discovered that injection of insulin would have a prolonged effect if mixed with protamine-rich salmon sperm. The necessity of a pH of 7 for activation made the handling of insulin difficult. Zinc was added to the mix as a stabilizer. By 1946, an easier-to-use crystallized form was developed, and it was marketed by 1950 as NPH insulin.

When a patient is overdosed with heparin, excessive bleeding can be a problem. Protamine sulfate is a valuable medication used for reversal of heparin. Protamine is a strongly basic substance that combines with the strongly acidic heparin to form a stable complex. The protamine-heparin complex is not an anticoagulant; protamine causes a dissociation of the heparin-antithrombin III complex, resulting in loss of heparin’s anticoagulant activity. Given too quickly it may cause hypotension or anaphylaxis and may cause allergic reactions to patients with fish hypersensitivity.

Leeches

From the anticoagulant effect of salmon sperm, we move to the world of Annelida. More than any other creature, the leech stands out as the epitome of biotherapy. Its name alone, Hirudo medicinalis, emphasizes its medical nature. Used by many ancient societies, the leech reached its zenith in mid-19th century France. Leeches were the fashion, women’s dresses were decorated with faux leeches, and cosmetics were applied to give that “healthy pale look” sometimes attained by being bled with leeches.

In 1833 more than 40 million leeches were imported into France. However, the leech’s days were numbered. The biggest blow was when Pierre Louis made his name as the father of medical statistics by proving leeches led to a worse outcome in treating pneumonia. The death of the leech was the birth of evidence-based medicine.

But all is not lost for the leech lover. The use of the leech as an anticoagulant was recognized in 1884. In its modern chemical form, recombinant leech saliva marketed under names such as lepirudin, is indicated for coronary thrombolysis, unstable angina hemodialysis, heparin-induced thrombocytopenia, and DVT prophylaxis. Recombinant hirudin, a man-made chemical similar to leech saliva, is manufactured in large quantities and is much easier to obtain than “milking” leeches. The mechanism of action is direct inhibition of thrombin. Leeches are making a comeback in the treatment of skin grafts, however. A mechanical leech has also been designed.

The Future

The argument for the protection of our planet’s biodiversity could not be more obvious. A new treatment for diabetes comes from Gila monsters. What novel substances lurk in the ever-shrinking rain forests? Whether from lizard or leech, the day of biotherapy is not yet done. Despite all this, I’m not cornering the market on synthetic eye of newt. TH

Jamie Newman, MD, FACP, is the physician editor of The Hospitalist, consultant, Hospital Internal Medicine, and assistant professor of internal medicine and medical history, Mayo Clinic College of Medicine, Rochester, Minn.

Editors’ note: “Alliances” is a series written about the relationships that hospitalists have with members of the clinical care team—from the team members’ points of view. Each installment of “Alliances” provides valuable, revealing feedback that hospitalists can use to continually improve their intrateam relationships and, ultimately, patient care.

Several months ago, a patient with decompensated end-stage liver disease was admitted to the Internal Medicine Hospitalist Service at the University of Texas Medical Branch in Galveston and required a paracentesis. One of the new hospitalist faculty members was taken aback when the physician assistant (PA) on the service volunteered to do the procedure. “He was surprised,” says Karen Kislingbury, PA-C, a member of SHM’s Non-Physician Provider Task Force and a PA with the Internal Medicine Hospitalist Service, “that the scope of practice for the physician assistant included [performing] procedures.”

PAs are not new to the hospital setting, and their inclusion as physician extenders to increase patient access to care will likely increase in the current regulatory environment—especially state-mandated staff/patient ratios and resident work hour limitations. The efficacy of utilizing physician extenders to improve patient care and outcomes has been validated in studies over the past two decades. A recent Journal of Trauma study found statistically significant reductions in floor, ICU, and overall hospital lengths of stay after incorporating physician extenders into their trauma service.1

However, hospitalists unfamiliar with PAs may not understand their colleagues’ roles and scope of practice. As her anecdote illustrated, Kislingbury notes that “although PAs aren’t new to the healthcare delivery system, and physicians have been utilizing us for a long time, our partnership in the unique setting of hospital medicine is kind of new.”

Kislingbury’s colleague Ryan Genzink, PA-C, who works with Hospitalists of West Michigan, a private hospitalists-only group that subcontracts hospitalist services to Spectrum Health of Grand Rapids, Mich., agrees with her assessment.

“There are more and more PAs and [nurse practitioners] working in hospital medicine, and I think there is a lot of curiosity and some apprehension on the part of people who have not worked with these non-physician providers,” says Genzink.

Genzink, also a member of SHM’s Non-Physician Provider Task Force, speculates that the apprehension of physicians who have not worked with PAs may be due to a misunderstanding of the PA’s role. “They’re either underestimating or overestimating exactly what a PA can do or what they are getting when they hire a PA,” he says.

A Short History of the Profession

PA programs officially began in the mid-1960s at Duke University Medical School (Durham, N.C.). Eugene Stead, MD, is credited with developing the concept of the physician assistant as a health professional who would work with physician supervision to extend patient access to care, according to the American Academy of Physician Assistants.

For the first class of PAs in 1965, Dr. Stead selected Navy corpsmen who had received medical training and experience during their service in Vietnam. The curriculum was based on Dr. Stead’s knowledge of fast-track training of physicians during World War II. From this early program, the profession has evolved to more than 130 programs that now adhere to rigorous national accreditation standards set forth by the independent Accreditation Review Commission on Education for the Physician Assistant (ARC-PA). The ARC-PA is sponsored by the American Medical Association and the American College of Surgeons, among many other professional medical organizations (www.aapa.org/geninfo1.html).

Scope of Practice

Prerequisites to PA programs include two years of college courses in basic and behavioral science, as well as prior experience in healthcare. According to a report generated by the Association of Physician Assistant Programs, most PA students have earned a bachelor’s degree and have an average of 38 months of healthcare experience before being admitted to a PA program.2

The first year of PA education comprises a didactic curriculum with coursework in anatomy, physiology, biochemistry, pharmacology, physical diagnosis, pathophysiology, microbiology, clinical laboratory sciences, behavioral sciences, and medical ethics. In the second year, students receive hands-on clinical training through a series of rotations—typically in family and internal medicine, obstetrics and gynecology, pediatrics, general surgery, emergency medicine, and psychiatry. By the time they graduate (typical PA programs last an average of 26 months), PAs will have completed more than 2,000 hours of supervised clinical practice.

PAs work in all areas of medicine. Although hospital bylaws and state regulations often stipulate the PA’s scope of practice, the major determinant of duties is the supervising physician. The relationship between supervising physician and PA, says Kislingbury, is a collaborative one. Duties are “defined on an individual basis, and they are determined based on our [PAs’] experience, the physicians’ experience with us, and then the nuances of the system and the hospital itself.

“The PA who is hired should know what his or her scope of practice is,” she continues. “By the time they have graduated and obtained their license, they should know what their state allows them to do.”

For instance, according to the American Academy of Physician Assistants, 48 of the 50 states, plus the District of Columbia and [the U.S. Territory of] Guam, authorize PAs to prescribe medications. In California, PA prescriptions are referred to as “written prescription transmittal orders.”

“For the most part,” says Genzink, “the supervising physician determines what the PA is capable of doing, within the guidelines of state law.”

Within Genzink’s hospital medicine group (with which he has been affiliated for five years) the physician and PA roles are very similar.

“We see the same type of patients in a team approach. For instance, it’s not uncommon for one of us to order a test early in the day, and then, when results come back, the other person may be discharging that patient or prescribing other treatments, if necessary,” he explains. “In general, the physicians take care of the more complicated patients, while PAs take care of more routine patients.”

Genzink’s group experience aligns with findings of a 1998 University of Pittsburgh School of Nursing Study, which evaluated provider roles and patient outcomes in an acute care setting.3 Compared with acute care nurse practitioners and PAs, residents in that study tended to care for patients who were older and sicker.

Genzink reports that in his group initial histories and physicals, as well as the consultations, are performed exclusively by the PAs and then the physician takes over for treatment. “Based on the acuity of the patient,” says Genzink, “the physician may be right down there to see the patient immediately.”

Areas for Improvement?

Although the two PAs interviewed for this article report positive experiences working with hospitalists, they admit that some physicians continue to hold misperceptions about the PA’s role in caring for patients.

Kislingbury says that hospitalists could improve their delegation of duties to the PAs and recognize their scope of practice. She admits that delegation duties can be improved through gaining experience. “Although the PA profession has been around for a while, there are a surprising number of institutions that do not utilize physician assistants on the wards in routine rounds and bedside-type care,” says Kislingbury.

“I think some of the problems develop when they [physicians] hire a PA and expect to get a physician—and they [don’t],” says Genzink. “The easiest way for me to explain the role is to compare it to a teaching model. All physicians have been through residency programs. They understand the hierarchy that involves training and teaching residents. PAs come out of school ‘green,’ with the assumption that training will go on at the workplace. So, if a physician takes the same stance toward a new PA as they would toward an intern, that is a pretty close comparison.

“You begin by letting PAs or interns do a few simple things, and as they master those, you teach them more,” he continues. “And then, hopefully, over time they’ve been able to master everything that the physician is able to master. [Employing a PA] is a significant investment. And, it takes time. Sometimes, that process can be very easy, depending on the person. Sometimes it can be very slow, and I think that’s sometimes where some of the frustration may come in.”

Genzink adds that in his hospital medicine group, the physicians are familiar with the idea that part of their job as supervising physicians is to train new PAs.

Kislingbury points that out that PAs can also play a role in informing the physician team members about the range of cases they are allowed to treat, thus furthering the collaboration between PAs and hospitalists: “It is merely a matter of educating the team members about what we can and cannot do.”

Accordingly, the SHM Non-Physician Provider Task Force was formed to provide a resource to hospitalists who work with PAs and have questions about scope of practice, reimbursement, and other issues as they pertain to PAs and nurse practitioners. (Visit www.hospitalmedicine.org for more information.) The Task Force is a resource for non-physicians providers, too, offering educational opportunities at SHM meetings, more visibility with the specialty, and a voice for advocacy.

The Positives of the Collaboration

While the PAs report that hospitalists could improve in communicating about their practice roles with PAs, “There are so many things that hospitalists do right!” says Kislingbury. Calling the experience of working with hospitalists a privilege, she says that “where it is a true partnership, we are treated as equals, we are given the responsibility that our experience will allow, and we are truly team members.

“Hospitalists are geared into the efficiencies of the system and the nuances of the hospital. These are subtleties that come with practicing in an area for a long period of time, not just coming in for a month and then leaving and returning,” she says. “Hospitalists know the daily ins and outs, and it is really a pleasure to learn from them.”

Prior to his affiliation with Hospitalists of West Michigan, Genzink was employed directly by a hospital in Grand Rapids. The physicians with whom he now works have been hospitalists almost exclusively throughout their medical careers. “One of the main benefits they offer is availability, simply because we [the group’s practice members] are in the hospital 24/7,” he says. “They also have more experience in dealing with more complex issues, just as do the PAs that are working in our system.”

What about the notion that PAs and nurse practitioners are more skilled or practiced with patient and family communications? One study by Rudy, et al. found that nurse practitioners and PAs were more likely than residents to discuss patients with bedside nurses and to interact with patients’ families.3 Genzink does not find this to be the case in his group’s practice.

“That presumption [that PAs are more communicative with families and patients] may have come about simply because as the demands on hospitalists continue to grow and the workload increases, adding the PA to the team means there are more people to do things like that [handle family communications],” he says. “Certainly, in our group, the PAs do lots of patient education, and we talk to patients about end-of-life issues and other difficult matters as well. But that is not delegated to them; in our group, both the PAs and the physicians participate equally in patient and family communication.”

Daily Learning

Hospitalists and PAs also complement each other in the interdisciplinary care team because, “as a general rule, hospitalists love to teach,” says Kislingbury. “They don’t forget that just because you have your PA degree your learning does not stop there. The PA profession is almost like on-the-job training. You are allowed to choose the specialty that you want, and you gain your experience when you enter that [arena], as opposed to an internship or residency, where you first gain experience and then enter the specialty. We so appreciate the ability of the hospitalist to teach because we are learning while doing, on a day-to-day basis. It’s invaluable to have their teaching.” TH

Gretchen Henkel also writes about dealing with difficult families in this issue.

Resources

1. Christmas AB, Reynolds J, Hodges S, et al. Physician extenders impact trauma systems. J Trauma. 2005 May;58(5):917-920.
2. Nineteenth Annual Report on Physician Assistant Educational Programs in the United States, 2002-2203. Alexandria, Va. Association of Physician Assistant Programs.
3. Rudy EB, Davidson LJ, Daly B, et al. Care activities and outcomes of patients cared for by acute care nurse practitioners, physician assistants, and resident physicians: a comparison. Am J Crit Care. 1998 Jul;7(4):267-281.

Editors’ note: “Alliances” is a series written about the relationships that hospitalists have with members of the clinical care team—from the team members’ points of view. Each installment of “Alliances” provides valuable, revealing feedback that hospitalists can use to continually improve their intrateam relationships and, ultimately, patient care.

Several months ago, a patient with decompensated end-stage liver disease was admitted to the Internal Medicine Hospitalist Service at the University of Texas Medical Branch in Galveston and required a paracentesis. One of the new hospitalist faculty members was taken aback when the physician assistant (PA) on the service volunteered to do the procedure. “He was surprised,” says Karen Kislingbury, PA-C, a member of SHM’s Non-Physician Provider Task Force and a PA with the Internal Medicine Hospitalist Service, “that the scope of practice for the physician assistant included [performing] procedures.”

PAs are not new to the hospital setting, and their inclusion as physician extenders to increase patient access to care will likely increase in the current regulatory environment—especially state-mandated staff/patient ratios and resident work hour limitations. The efficacy of utilizing physician extenders to improve patient care and outcomes has been validated in studies over the past two decades. A recent Journal of Trauma study found statistically significant reductions in floor, ICU, and overall hospital lengths of stay after incorporating physician extenders into their trauma service.1

However, hospitalists unfamiliar with PAs may not understand their colleagues’ roles and scope of practice. As her anecdote illustrated, Kislingbury notes that “although PAs aren’t new to the healthcare delivery system, and physicians have been utilizing us for a long time, our partnership in the unique setting of hospital medicine is kind of new.”

Kislingbury’s colleague Ryan Genzink, PA-C, who works with Hospitalists of West Michigan, a private hospitalists-only group that subcontracts hospitalist services to Spectrum Health of Grand Rapids, Mich., agrees with her assessment.

“There are more and more PAs and [nurse practitioners] working in hospital medicine, and I think there is a lot of curiosity and some apprehension on the part of people who have not worked with these non-physician providers,” says Genzink.

Genzink, also a member of SHM’s Non-Physician Provider Task Force, speculates that the apprehension of physicians who have not worked with PAs may be due to a misunderstanding of the PA’s role. “They’re either underestimating or overestimating exactly what a PA can do or what they are getting when they hire a PA,” he says.

A Short History of the Profession

PA programs officially began in the mid-1960s at Duke University Medical School (Durham, N.C.). Eugene Stead, MD, is credited with developing the concept of the physician assistant as a health professional who would work with physician supervision to extend patient access to care, according to the American Academy of Physician Assistants.

For the first class of PAs in 1965, Dr. Stead selected Navy corpsmen who had received medical training and experience during their service in Vietnam. The curriculum was based on Dr. Stead’s knowledge of fast-track training of physicians during World War II. From this early program, the profession has evolved to more than 130 programs that now adhere to rigorous national accreditation standards set forth by the independent Accreditation Review Commission on Education for the Physician Assistant (ARC-PA). The ARC-PA is sponsored by the American Medical Association and the American College of Surgeons, among many other professional medical organizations (www.aapa.org/geninfo1.html).

Scope of Practice

Prerequisites to PA programs include two years of college courses in basic and behavioral science, as well as prior experience in healthcare. According to a report generated by the Association of Physician Assistant Programs, most PA students have earned a bachelor’s degree and have an average of 38 months of healthcare experience before being admitted to a PA program.2

The first year of PA education comprises a didactic curriculum with coursework in anatomy, physiology, biochemistry, pharmacology, physical diagnosis, pathophysiology, microbiology, clinical laboratory sciences, behavioral sciences, and medical ethics. In the second year, students receive hands-on clinical training through a series of rotations—typically in family and internal medicine, obstetrics and gynecology, pediatrics, general surgery, emergency medicine, and psychiatry. By the time they graduate (typical PA programs last an average of 26 months), PAs will have completed more than 2,000 hours of supervised clinical practice.

PAs work in all areas of medicine. Although hospital bylaws and state regulations often stipulate the PA’s scope of practice, the major determinant of duties is the supervising physician. The relationship between supervising physician and PA, says Kislingbury, is a collaborative one. Duties are “defined on an individual basis, and they are determined based on our [PAs’] experience, the physicians’ experience with us, and then the nuances of the system and the hospital itself.

“The PA who is hired should know what his or her scope of practice is,” she continues. “By the time they have graduated and obtained their license, they should know what their state allows them to do.”

For instance, according to the American Academy of Physician Assistants, 48 of the 50 states, plus the District of Columbia and [the U.S. Territory of] Guam, authorize PAs to prescribe medications. In California, PA prescriptions are referred to as “written prescription transmittal orders.”

“For the most part,” says Genzink, “the supervising physician determines what the PA is capable of doing, within the guidelines of state law.”

Within Genzink’s hospital medicine group (with which he has been affiliated for five years) the physician and PA roles are very similar.

“We see the same type of patients in a team approach. For instance, it’s not uncommon for one of us to order a test early in the day, and then, when results come back, the other person may be discharging that patient or prescribing other treatments, if necessary,” he explains. “In general, the physicians take care of the more complicated patients, while PAs take care of more routine patients.”

Genzink’s group experience aligns with findings of a 1998 University of Pittsburgh School of Nursing Study, which evaluated provider roles and patient outcomes in an acute care setting.3 Compared with acute care nurse practitioners and PAs, residents in that study tended to care for patients who were older and sicker.

Genzink reports that in his group initial histories and physicals, as well as the consultations, are performed exclusively by the PAs and then the physician takes over for treatment. “Based on the acuity of the patient,” says Genzink, “the physician may be right down there to see the patient immediately.”

Areas for Improvement?

Although the two PAs interviewed for this article report positive experiences working with hospitalists, they admit that some physicians continue to hold misperceptions about the PA’s role in caring for patients.

Kislingbury says that hospitalists could improve their delegation of duties to the PAs and recognize their scope of practice. She admits that delegation duties can be improved through gaining experience. “Although the PA profession has been around for a while, there are a surprising number of institutions that do not utilize physician assistants on the wards in routine rounds and bedside-type care,” says Kislingbury.

“I think some of the problems develop when they [physicians] hire a PA and expect to get a physician—and they [don’t],” says Genzink. “The easiest way for me to explain the role is to compare it to a teaching model. All physicians have been through residency programs. They understand the hierarchy that involves training and teaching residents. PAs come out of school ‘green,’ with the assumption that training will go on at the workplace. So, if a physician takes the same stance toward a new PA as they would toward an intern, that is a pretty close comparison.

“You begin by letting PAs or interns do a few simple things, and as they master those, you teach them more,” he continues. “And then, hopefully, over time they’ve been able to master everything that the physician is able to master. [Employing a PA] is a significant investment. And, it takes time. Sometimes, that process can be very easy, depending on the person. Sometimes it can be very slow, and I think that’s sometimes where some of the frustration may come in.”

Genzink adds that in his hospital medicine group, the physicians are familiar with the idea that part of their job as supervising physicians is to train new PAs.

Kislingbury points that out that PAs can also play a role in informing the physician team members about the range of cases they are allowed to treat, thus furthering the collaboration between PAs and hospitalists: “It is merely a matter of educating the team members about what we can and cannot do.”

Accordingly, the SHM Non-Physician Provider Task Force was formed to provide a resource to hospitalists who work with PAs and have questions about scope of practice, reimbursement, and other issues as they pertain to PAs and nurse practitioners. (Visit www.hospitalmedicine.org for more information.) The Task Force is a resource for non-physicians providers, too, offering educational opportunities at SHM meetings, more visibility with the specialty, and a voice for advocacy.

The Positives of the Collaboration

While the PAs report that hospitalists could improve in communicating about their practice roles with PAs, “There are so many things that hospitalists do right!” says Kislingbury. Calling the experience of working with hospitalists a privilege, she says that “where it is a true partnership, we are treated as equals, we are given the responsibility that our experience will allow, and we are truly team members.

“Hospitalists are geared into the efficiencies of the system and the nuances of the hospital. These are subtleties that come with practicing in an area for a long period of time, not just coming in for a month and then leaving and returning,” she says. “Hospitalists know the daily ins and outs, and it is really a pleasure to learn from them.”

Prior to his affiliation with Hospitalists of West Michigan, Genzink was employed directly by a hospital in Grand Rapids. The physicians with whom he now works have been hospitalists almost exclusively throughout their medical careers. “One of the main benefits they offer is availability, simply because we [the group’s practice members] are in the hospital 24/7,” he says. “They also have more experience in dealing with more complex issues, just as do the PAs that are working in our system.”

What about the notion that PAs and nurse practitioners are more skilled or practiced with patient and family communications? One study by Rudy, et al. found that nurse practitioners and PAs were more likely than residents to discuss patients with bedside nurses and to interact with patients’ families.3 Genzink does not find this to be the case in his group’s practice.

“That presumption [that PAs are more communicative with families and patients] may have come about simply because as the demands on hospitalists continue to grow and the workload increases, adding the PA to the team means there are more people to do things like that [handle family communications],” he says. “Certainly, in our group, the PAs do lots of patient education, and we talk to patients about end-of-life issues and other difficult matters as well. But that is not delegated to them; in our group, both the PAs and the physicians participate equally in patient and family communication.”

Daily Learning

Hospitalists and PAs also complement each other in the interdisciplinary care team because, “as a general rule, hospitalists love to teach,” says Kislingbury. “They don’t forget that just because you have your PA degree your learning does not stop there. The PA profession is almost like on-the-job training. You are allowed to choose the specialty that you want, and you gain your experience when you enter that [arena], as opposed to an internship or residency, where you first gain experience and then enter the specialty. We so appreciate the ability of the hospitalist to teach because we are learning while doing, on a day-to-day basis. It’s invaluable to have their teaching.” TH

Gretchen Henkel also writes about dealing with difficult families in this issue.

Resources

1. Christmas AB, Reynolds J, Hodges S, et al. Physician extenders impact trauma systems. J Trauma. 2005 May;58(5):917-920.
2. Nineteenth Annual Report on Physician Assistant Educational Programs in the United States, 2002-2203. Alexandria, Va. Association of Physician Assistant Programs.
3. Rudy EB, Davidson LJ, Daly B, et al. Care activities and outcomes of patients cared for by acute care nurse practitioners, physician assistants, and resident physicians: a comparison. Am J Crit Care. 1998 Jul;7(4):267-281.

Editors’ note: “Alliances” is a series written about the relationships that hospitalists have with members of the clinical care team—from the team members’ points of view. Each installment of “Alliances” provides valuable, revealing feedback that hospitalists can use to continually improve their intrateam relationships and, ultimately, patient care.

Several months ago, a patient with decompensated end-stage liver disease was admitted to the Internal Medicine Hospitalist Service at the University of Texas Medical Branch in Galveston and required a paracentesis. One of the new hospitalist faculty members was taken aback when the physician assistant (PA) on the service volunteered to do the procedure. “He was surprised,” says Karen Kislingbury, PA-C, a member of SHM’s Non-Physician Provider Task Force and a PA with the Internal Medicine Hospitalist Service, “that the scope of practice for the physician assistant included [performing] procedures.”

PAs are not new to the hospital setting, and their inclusion as physician extenders to increase patient access to care will likely increase in the current regulatory environment—especially state-mandated staff/patient ratios and resident work hour limitations. The efficacy of utilizing physician extenders to improve patient care and outcomes has been validated in studies over the past two decades. A recent Journal of Trauma study found statistically significant reductions in floor, ICU, and overall hospital lengths of stay after incorporating physician extenders into their trauma service.1

However, hospitalists unfamiliar with PAs may not understand their colleagues’ roles and scope of practice. As her anecdote illustrated, Kislingbury notes that “although PAs aren’t new to the healthcare delivery system, and physicians have been utilizing us for a long time, our partnership in the unique setting of hospital medicine is kind of new.”

Kislingbury’s colleague Ryan Genzink, PA-C, who works with Hospitalists of West Michigan, a private hospitalists-only group that subcontracts hospitalist services to Spectrum Health of Grand Rapids, Mich., agrees with her assessment.

“There are more and more PAs and [nurse practitioners] working in hospital medicine, and I think there is a lot of curiosity and some apprehension on the part of people who have not worked with these non-physician providers,” says Genzink.

Genzink, also a member of SHM’s Non-Physician Provider Task Force, speculates that the apprehension of physicians who have not worked with PAs may be due to a misunderstanding of the PA’s role. “They’re either underestimating or overestimating exactly what a PA can do or what they are getting when they hire a PA,” he says.

A Short History of the Profession

PA programs officially began in the mid-1960s at Duke University Medical School (Durham, N.C.). Eugene Stead, MD, is credited with developing the concept of the physician assistant as a health professional who would work with physician supervision to extend patient access to care, according to the American Academy of Physician Assistants.

For the first class of PAs in 1965, Dr. Stead selected Navy corpsmen who had received medical training and experience during their service in Vietnam. The curriculum was based on Dr. Stead’s knowledge of fast-track training of physicians during World War II. From this early program, the profession has evolved to more than 130 programs that now adhere to rigorous national accreditation standards set forth by the independent Accreditation Review Commission on Education for the Physician Assistant (ARC-PA). The ARC-PA is sponsored by the American Medical Association and the American College of Surgeons, among many other professional medical organizations (www.aapa.org/geninfo1.html).

Scope of Practice

Prerequisites to PA programs include two years of college courses in basic and behavioral science, as well as prior experience in healthcare. According to a report generated by the Association of Physician Assistant Programs, most PA students have earned a bachelor’s degree and have an average of 38 months of healthcare experience before being admitted to a PA program.2

The first year of PA education comprises a didactic curriculum with coursework in anatomy, physiology, biochemistry, pharmacology, physical diagnosis, pathophysiology, microbiology, clinical laboratory sciences, behavioral sciences, and medical ethics. In the second year, students receive hands-on clinical training through a series of rotations—typically in family and internal medicine, obstetrics and gynecology, pediatrics, general surgery, emergency medicine, and psychiatry. By the time they graduate (typical PA programs last an average of 26 months), PAs will have completed more than 2,000 hours of supervised clinical practice.

PAs work in all areas of medicine. Although hospital bylaws and state regulations often stipulate the PA’s scope of practice, the major determinant of duties is the supervising physician. The relationship between supervising physician and PA, says Kislingbury, is a collaborative one. Duties are “defined on an individual basis, and they are determined based on our [PAs’] experience, the physicians’ experience with us, and then the nuances of the system and the hospital itself.

“The PA who is hired should know what his or her scope of practice is,” she continues. “By the time they have graduated and obtained their license, they should know what their state allows them to do.”

For instance, according to the American Academy of Physician Assistants, 48 of the 50 states, plus the District of Columbia and [the U.S. Territory of] Guam, authorize PAs to prescribe medications. In California, PA prescriptions are referred to as “written prescription transmittal orders.”

“For the most part,” says Genzink, “the supervising physician determines what the PA is capable of doing, within the guidelines of state law.”

Within Genzink’s hospital medicine group (with which he has been affiliated for five years) the physician and PA roles are very similar.

“We see the same type of patients in a team approach. For instance, it’s not uncommon for one of us to order a test early in the day, and then, when results come back, the other person may be discharging that patient or prescribing other treatments, if necessary,” he explains. “In general, the physicians take care of the more complicated patients, while PAs take care of more routine patients.”

Genzink’s group experience aligns with findings of a 1998 University of Pittsburgh School of Nursing Study, which evaluated provider roles and patient outcomes in an acute care setting.3 Compared with acute care nurse practitioners and PAs, residents in that study tended to care for patients who were older and sicker.

Genzink reports that in his group initial histories and physicals, as well as the consultations, are performed exclusively by the PAs and then the physician takes over for treatment. “Based on the acuity of the patient,” says Genzink, “the physician may be right down there to see the patient immediately.”

Areas for Improvement?

Although the two PAs interviewed for this article report positive experiences working with hospitalists, they admit that some physicians continue to hold misperceptions about the PA’s role in caring for patients.

Kislingbury says that hospitalists could improve their delegation of duties to the PAs and recognize their scope of practice. She admits that delegation duties can be improved through gaining experience. “Although the PA profession has been around for a while, there are a surprising number of institutions that do not utilize physician assistants on the wards in routine rounds and bedside-type care,” says Kislingbury.

“I think some of the problems develop when they [physicians] hire a PA and expect to get a physician—and they [don’t],” says Genzink. “The easiest way for me to explain the role is to compare it to a teaching model. All physicians have been through residency programs. They understand the hierarchy that involves training and teaching residents. PAs come out of school ‘green,’ with the assumption that training will go on at the workplace. So, if a physician takes the same stance toward a new PA as they would toward an intern, that is a pretty close comparison.

“You begin by letting PAs or interns do a few simple things, and as they master those, you teach them more,” he continues. “And then, hopefully, over time they’ve been able to master everything that the physician is able to master. [Employing a PA] is a significant investment. And, it takes time. Sometimes, that process can be very easy, depending on the person. Sometimes it can be very slow, and I think that’s sometimes where some of the frustration may come in.”

Genzink adds that in his hospital medicine group, the physicians are familiar with the idea that part of their job as supervising physicians is to train new PAs.

Kislingbury points that out that PAs can also play a role in informing the physician team members about the range of cases they are allowed to treat, thus furthering the collaboration between PAs and hospitalists: “It is merely a matter of educating the team members about what we can and cannot do.”

Accordingly, the SHM Non-Physician Provider Task Force was formed to provide a resource to hospitalists who work with PAs and have questions about scope of practice, reimbursement, and other issues as they pertain to PAs and nurse practitioners. (Visit www.hospitalmedicine.org for more information.) The Task Force is a resource for non-physicians providers, too, offering educational opportunities at SHM meetings, more visibility with the specialty, and a voice for advocacy.

The Positives of the Collaboration

While the PAs report that hospitalists could improve in communicating about their practice roles with PAs, “There are so many things that hospitalists do right!” says Kislingbury. Calling the experience of working with hospitalists a privilege, she says that “where it is a true partnership, we are treated as equals, we are given the responsibility that our experience will allow, and we are truly team members.

“Hospitalists are geared into the efficiencies of the system and the nuances of the hospital. These are subtleties that come with practicing in an area for a long period of time, not just coming in for a month and then leaving and returning,” she says. “Hospitalists know the daily ins and outs, and it is really a pleasure to learn from them.”

Prior to his affiliation with Hospitalists of West Michigan, Genzink was employed directly by a hospital in Grand Rapids. The physicians with whom he now works have been hospitalists almost exclusively throughout their medical careers. “One of the main benefits they offer is availability, simply because we [the group’s practice members] are in the hospital 24/7,” he says. “They also have more experience in dealing with more complex issues, just as do the PAs that are working in our system.”

What about the notion that PAs and nurse practitioners are more skilled or practiced with patient and family communications? One study by Rudy, et al. found that nurse practitioners and PAs were more likely than residents to discuss patients with bedside nurses and to interact with patients’ families.3 Genzink does not find this to be the case in his group’s practice.

“That presumption [that PAs are more communicative with families and patients] may have come about simply because as the demands on hospitalists continue to grow and the workload increases, adding the PA to the team means there are more people to do things like that [handle family communications],” he says. “Certainly, in our group, the PAs do lots of patient education, and we talk to patients about end-of-life issues and other difficult matters as well. But that is not delegated to them; in our group, both the PAs and the physicians participate equally in patient and family communication.”

Daily Learning

Hospitalists and PAs also complement each other in the interdisciplinary care team because, “as a general rule, hospitalists love to teach,” says Kislingbury. “They don’t forget that just because you have your PA degree your learning does not stop there. The PA profession is almost like on-the-job training. You are allowed to choose the specialty that you want, and you gain your experience when you enter that [arena], as opposed to an internship or residency, where you first gain experience and then enter the specialty. We so appreciate the ability of the hospitalist to teach because we are learning while doing, on a day-to-day basis. It’s invaluable to have their teaching.” TH

Gretchen Henkel also writes about dealing with difficult families in this issue.

Resources

1. Christmas AB, Reynolds J, Hodges S, et al. Physician extenders impact trauma systems. J Trauma. 2005 May;58(5):917-920.
2. Nineteenth Annual Report on Physician Assistant Educational Programs in the United States, 2002-2203. Alexandria, Va. Association of Physician Assistant Programs.
3. Rudy EB, Davidson LJ, Daly B, et al. Care activities and outcomes of patients cared for by acute care nurse practitioners, physician assistants, and resident physicians: a comparison. Am J Crit Care. 1998 Jul;7(4):267-281.

Rothschild JM, Landrigan CP, Cronin JW, et al. The critical care safety study: the incidence and nature of adverse events and serious medical errors in intensive care. Crit Care Med. 2005;33:1694-1700.

Background: Critically ill patients require complex, immediate, high-intensity care, potentially placing them at increased risk of iatrogenic injury. The frequency and nature of adverse events and errors in the modern ICU have not been clearly defined.

Methods: Harvard researchers conducted a prospective, one-year, observational study of a MICU and a CCU at a tertiary care medical center. Adverse events and medical errors were identified by a four-pronged approach: direct 24-hour observation of interns, voluntary incident reporting, a computerized adverse drug event monitoring system, and chart abstraction. Two physicians independently assessed the type, severity, and preventability of the incidents.

Results: A total of 391 patients comprising 1,490 patient-days were observed and included. Twenty percent of all patients suffered an adverse event, 45% of which were preventable and 13% of which were felt to be life-threatening. There were 223 serious errors (those that caused harm or had the potential to cause harm) observed of which 11% were life threatening. Medication adverse events and medication errors accounted for a large proportion of the incidents during the study. Slips and lapses in care were much more common than rule-based (such as using the wrong protocol) or knowledge-based mistakes.

Discussion: Since the Institute of Medicine report in 1999, there has been an increasing focus on patient safety in the inpatient setting. Based on the results of this study and others, it appears the high-intensity, fast-paced nature of critical care places patients at substantial risk for iatrogenic injury. Up to 20% of patients admitted to the ICU in this study suffered an adverse event or a medical error, which translates into 0.8 adverse events and 1.5 serious medical errors per day in a 10-bed ICU.

Because failure to carry out intended plans (usually secondary to slips and lapses on the part of healthcare providers) was the most common cause of adverse events and errors, the authors address possible solutions. They propose employing computerized-order entry, clinical pharmacists in the ICU, closed ICU staffing, “smart” intravenous pumps, and improved teamwork and communication among healthcare providers. Hospitalists often manage critically ill patients and should be aware of the high risk of medical errors and should consider implementing specific systems changes to mitigate the risk.

The Value of Obtaining Blood Cultures in Pneumonia Pts

Kennedy M, Bates DW, Wright SB, et al. Do emergency department blood cultures change practice in patients with pneumonia? Ann Emerg Med. 2005 Nov;46(5):393-400.

Background: Previous observational studies in patients hospitalized with community-acquired pneumonia (CAP) have shown obtaining blood cultures may have a mortality benefit. This practice has become expert guideline-recommended, the standard of care, as well as a quality marker in the management of CAP. Several recent studies have questioned the utility and cost-effectiveness of this practice.

Methods: Harvard researchers performed a prospective, observational, cohort study of adults admitted to an urban university medical center. Researchers identified patients who had all of the following: clinical CAP, radiographic CAP, and blood cultures at admission. Blood cultures were classified as positive, negative, or contaminated based on previously established criteria. Data were collected on antimicrobial sensitivities, empiric antibiotic choices, and antibiotic changes.

Results: In one year, 414 patients with clinical and radiographic CAP had blood cultures at the time of admission. Twenty-nine of 414 (7%) of patients had true bacteremia while 25 of 414 (6%) had contaminants. Antibiotic therapy was altered in response to blood culture results in 15 of 414 patients (3.6%), of which 11 (2.7%) had therapy narrowed and four (1.0%) had therapy broadened. Of the 11 patients with bacteremia whose therapy was not changed, culture results supported narrowing therapy in eight cases but this was not done.

Discussion: This well done prospective observational study adds to a growing body of evidence questioning the utility of routine blood cultures on all patients hospitalized with CAP. The argument traditionally has been made that blood cultures allow clinicians to narrow or broaden antibiotics based on sensitivities. Yet, empiric therapy was broadened in response to bacteremia in only a small fraction of patients (1%) and in only 11 of 19 patients was therapy appropriately narrowed based on the blood cultures. The study did not measure the impact of blood cultures on clinical outcomes, but these striking results reveal that routine blood cultures rarely alter our management of hospitalized patients with CAP.

Further, many have argued obtaining routine blood cultures in CAP can have negative consequences. Blood cultures are relatively costly and time intensive, contaminated blood cultures can lead to repeated testing and increased length of stay, and delays in obtaining blood cultures can delay antibiotic administration, another important quality marker in CAP. For now, it remains the standard of care to obtain blood cultures in these patients, but hospitalists should be aware of the limitations of this practice and consider focusing on other clinical interventions and quality measures in CAP.

A Review Study: A Dyspneic Emergency Patient

Wang CS, FitzGerald JM, Schulzer M, et al. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294:944-1956.

Background: Distinguishing CHF from non-cardiac causes of dyspnea is a major challenge for hospitalists and emergency physicians, particularly in patients with a prior history of cardiac disease. Traditionally, clinicians have relied on the history, physical examination, and basic tests (chest X-ray and electrocardiogram) to diagnose CHF, but rapid B-type natriuretic peptide (BNP) testing is now widely incorporated as well.

A previous article in the Rational Clinical Examination series (Can the clinical examination diagnose left-sided heart failure in adults? JAMA. 1997;277(21):1712-1719) found that systolic dysfunction was moderately well predicted by an abnormal apical impulse on physical examination, radiographic cardiomegaly or venous redistribution, or electrocardiographic q waves or left bundle branch block.

Methods: In this review, the authors update and extend previous findings by also assessing the utility of serum BNP testing. The authors identified articles evaluating the diagnostic accuracy of the clinical exam and laboratory testing in diagnosing CHF in patients presenting to the emergency department with undifferentiated dyspnea. The “gold standard” was a clinical diagnosis of CHF made by the treating clinicians after an appropriate diagnostic workup. Summary likelihood ratios (LRs) were calculated using meta-analytic methodology.

Results/discussion: The authors determined that several findings increase the probability of CHF. A prior history of CHF (LR 5.8, CI 4.1-8.0) or myocardial infarction (LR 3.1, 95% CI 2.0-4.9), symptoms of paroxysmal nocturnal dyspnea (LR 2.6, 95% CI 1.5-4.5) and orthopnea (LR 2.2, 95% CI 1.2-3.9) were the most predictive historical factors. On physical examination, the presence of an S3 (LR 11, 95% CI 4.9-25), jugular venous distension (5.1, 95% CI 3.2-7.9), lung rales (LR 2.8, 95% CI 1.9-4.1), and peripheral edema (2.3, 95% CI 1.5-3.7) increased the probability of CHF. In interpreting these results, it is helpful to remember that a likelihood ratio of 2 increases the post-test probability by about 15%, and an LR of 5 increases the post-test probability by about 30%. Thus, a prior history of CHF and presence of an S3 or jugular venous distension are the most useful findings. Interestingly, clinician’s gestalt was equally predictive (LR 4.4, 95% CI 1.8-10.0.)

The most useful radiographic findings were venous congestion (LR 12.0, 95% CI 6.8-21) and the presence of cardiomegaly (LR 3.3; 95% CI 2.4-4.7). The single most predictive ECG finding was atrial fibrillation (LR 3.8; 95% CI 2.7-8.8); any abnormality on ECG had an LR of 2.2 (95% CI 1.6-3.1). Serum BNP levels were not more predictive of CHF than the history or physical examination; a BNP of >250 was associated with an LR of 4.6 (95% CI 2.6-8.0).

Few findings markedly decreased the probability of CHF. Here, it is helpful to remember that an LR of 0.5 decreases the post-test probability by about 15%, and an LR of 0.2 decreases the post-test probability by about 30%. With these in mind, the absence of cardiomegaly on CXR significantly changes the post-test probability (LR 0.33; 95% CI 0.23-0.48). A serum BNP level of less than 100pg/ml strongly argues against CHF, with an LR of 0.11 (95% CI 0.07-0.16); this finding lowers the post-test probability of CHF by about 45% compared to the pre-test probability.

In summary, the most useful findings for ruling in CHF in dyspneic emergency department patients were clinical gestalt, a prior history of CHF, findings of an S3 or jugular venous distension, and radiographic findings of venous congestion or cardiomegaly. Absence of radiographic cardiomegaly and a BNP of less than 100pg/ml argue against CHF. These must be interpreted in the context of the clinical pre-test probability of CHF, as none of the findings had likelihood ratios sufficient to be diagnostic of CHF when used individually.

What Should I Wear Today?

Rehman SU, Nietert PJ, Cope DW, Kilpatrick AO. What to wear today? Effect of doctor’s attire on the trust and confidence of patients. Am J Med. 2005 Nov; 118(11): 1279-1286.

Background: This study addresses the prototypical everyday clinical dilemma: What should I wear to work?

Methods: Patients and visitors to an outpatient Veterans Affairs internal medicine clinic in South Carolina were shown photographs of male and female physicians in four different styles of dress:

1. Professional (male physician wearing white coat with tie, female physician wearing white coat with tailored skirt or trousers);
2. Business (suit and tie for male, tailored trouser or skirt for female);
3. Surgical (surgical scrubs for both male and female): and
4. Casual (jeans and t-shirt or short skirt).

The study was randomized so that male and female respondents viewed photographs of either male or female physicians. Respondents were asked to report how strongly they felt about the importance of their physician’s appearance, and their preference for each style of dress; specifically, respondents were asked which physician was the most trustworthy, which physician they felt most comfortable with for routine examinations and emergencies, and which physician they felt most comfortable discussing psychological, sexual, and social problems with.

Results: Respondents overwhelmingly preferred professional attire for all questions: 76.3% felt most comfortable with a professionally dressed physician for all encounters, with surgical scrubs a distant second (10.2%), ahead of business dress (8.8%). Respondents were also significantly more willing to discuss psychological, sexual, and social problems with a professionally dressed physician. Even for care in an emergency situation, respondents still expressed a significant preference for professional attire over scrubs.

In a logistic regression model, patients who were older, African-American, and had less than a high school education were significantly more likely to prefer professional attire. Interestingly, female respondents who viewed photographs of female physicians placed significantly greater emphasis on physician’s attire than did male respondents.

Discussion: The study is clearly subject to caveats, chiefly that it was conducted at a single VA clinic and that only one aspect of the physician-patient encounter was addressed. Undoubtedly, patient’s preferences were influenced by the popular portrayal of physicians on TV shows. Nevertheless, given that hospitalists typically see older patients with whom they are not familiar, the initial clinical encounter may indeed by influenced by something as simple as wearing a white coat.

UA by Nephrologist Versus Hospital-Based Clinical Labs

Tsai JJ, Yeun JY, Kumar VA, Don BR. Comparison and interpretation of urinalysis performed by a nephrologist versus a hospital-based clinical laboratory. Am J Kidney Dis. 2005 Nov;46(5):820-829.

Background: Distinguishing the correct cause of acute renal failure is a frequent clinical dilemma for hospitalists, particularly diagnosing acute tubular necrosis (ATN), which is the most common cause of in-hospital acute renal failure. Although urinalysis with microscopy is the first test ordered on noting an abnormal serum creatinine, most hospitalists rely on the results generated by a laboratory technician. Anecdotally, many nephrologists have noted significant differences between urinalysis results performed by technicians and results found by nephrologists.

Methods: This study enrolled 26 patients hospitalized with acute renal failure on whom nephrology consultation was obtained. Urinalysis was performed both by laboratory personnel and a nephrologist (nephrologist A) who was blinded to the patient’s clinical information. Both sets of urinalysis results were independently used by nephrologist A and a second nephrologist (nephrologist B) to arrive at a clinical diagnosis for the patient, without having access to any other clinical information. These diagnoses were compared to the final diagnosis determined by the consulting nephrology service, who themselves did not have access to the diagnosis of either nephrologist A or B.

Results: The influence of having a nephrologist perform and interpret the urinalysis was striking. Nephrologist A was able to correctly diagnose 92.3% of cases based solely on his interpretation of the urinalysis. However, when given only the laboratory report of the urinalysis, both nephrologists were unable to diagnose most cases (23.1% for nephrologist A and 19.2% for nephrologist B). The major difference appeared to be in nephrologist A’s ability to find renal tubular epithelial (RTE) cells and RTE casts, which are pathognomonic of ATN. RTE cells and granular casts were frequently misinterpreted as squamous epithelial cells by laboratory personnel. This was particularly important as 81% of patients in the study had ATN as the primary cause of renal failure. Acanthocytes (dysmorphic red blood cells) were also missed by laboratory personnel in all six patients who were subsequently diagnosed with glomerulonephritis; nephrologist A correctly noted acanthocytes in five of these patients, and arrived at the correct diagnosis in all six patients.

Discussion: Microscopic evaluation of urine sediment has become a lost art among physicians, especially since passage of the Clinical Laboratory Improvement Amendments (CLIA) in 1988, which mandated that only CLIA-certified personnel could perform most laboratory tests. While it is probably unrealistic to call for training in microscopic urinalysis for all physicians, hospitalists in particular would benefit from such training, and at the very least should be mindful that laboratory urinalysis results may miss subtle findings that can be invaluable in diagnosing acute renal failure. This study points out the need for greater oversight and training of laboratory personnel, and serves as a reminder to clinicians that laboratory results should not be considered the gold standard. TH

Rothschild JM, Landrigan CP, Cronin JW, et al. The critical care safety study: the incidence and nature of adverse events and serious medical errors in intensive care. Crit Care Med. 2005;33:1694-1700.

Background: Critically ill patients require complex, immediate, high-intensity care, potentially placing them at increased risk of iatrogenic injury. The frequency and nature of adverse events and errors in the modern ICU have not been clearly defined.

Methods: Harvard researchers conducted a prospective, one-year, observational study of a MICU and a CCU at a tertiary care medical center. Adverse events and medical errors were identified by a four-pronged approach: direct 24-hour observation of interns, voluntary incident reporting, a computerized adverse drug event monitoring system, and chart abstraction. Two physicians independently assessed the type, severity, and preventability of the incidents.

Results: A total of 391 patients comprising 1,490 patient-days were observed and included. Twenty percent of all patients suffered an adverse event, 45% of which were preventable and 13% of which were felt to be life-threatening. There were 223 serious errors (those that caused harm or had the potential to cause harm) observed of which 11% were life threatening. Medication adverse events and medication errors accounted for a large proportion of the incidents during the study. Slips and lapses in care were much more common than rule-based (such as using the wrong protocol) or knowledge-based mistakes.

Discussion: Since the Institute of Medicine report in 1999, there has been an increasing focus on patient safety in the inpatient setting. Based on the results of this study and others, it appears the high-intensity, fast-paced nature of critical care places patients at substantial risk for iatrogenic injury. Up to 20% of patients admitted to the ICU in this study suffered an adverse event or a medical error, which translates into 0.8 adverse events and 1.5 serious medical errors per day in a 10-bed ICU.

Because failure to carry out intended plans (usually secondary to slips and lapses on the part of healthcare providers) was the most common cause of adverse events and errors, the authors address possible solutions. They propose employing computerized-order entry, clinical pharmacists in the ICU, closed ICU staffing, “smart” intravenous pumps, and improved teamwork and communication among healthcare providers. Hospitalists often manage critically ill patients and should be aware of the high risk of medical errors and should consider implementing specific systems changes to mitigate the risk.

The Value of Obtaining Blood Cultures in Pneumonia Pts

Kennedy M, Bates DW, Wright SB, et al. Do emergency department blood cultures change practice in patients with pneumonia? Ann Emerg Med. 2005 Nov;46(5):393-400.

Background: Previous observational studies in patients hospitalized with community-acquired pneumonia (CAP) have shown obtaining blood cultures may have a mortality benefit. This practice has become expert guideline-recommended, the standard of care, as well as a quality marker in the management of CAP. Several recent studies have questioned the utility and cost-effectiveness of this practice.

Methods: Harvard researchers performed a prospective, observational, cohort study of adults admitted to an urban university medical center. Researchers identified patients who had all of the following: clinical CAP, radiographic CAP, and blood cultures at admission. Blood cultures were classified as positive, negative, or contaminated based on previously established criteria. Data were collected on antimicrobial sensitivities, empiric antibiotic choices, and antibiotic changes.

Results: In one year, 414 patients with clinical and radiographic CAP had blood cultures at the time of admission. Twenty-nine of 414 (7%) of patients had true bacteremia while 25 of 414 (6%) had contaminants. Antibiotic therapy was altered in response to blood culture results in 15 of 414 patients (3.6%), of which 11 (2.7%) had therapy narrowed and four (1.0%) had therapy broadened. Of the 11 patients with bacteremia whose therapy was not changed, culture results supported narrowing therapy in eight cases but this was not done.

Discussion: This well done prospective observational study adds to a growing body of evidence questioning the utility of routine blood cultures on all patients hospitalized with CAP. The argument traditionally has been made that blood cultures allow clinicians to narrow or broaden antibiotics based on sensitivities. Yet, empiric therapy was broadened in response to bacteremia in only a small fraction of patients (1%) and in only 11 of 19 patients was therapy appropriately narrowed based on the blood cultures. The study did not measure the impact of blood cultures on clinical outcomes, but these striking results reveal that routine blood cultures rarely alter our management of hospitalized patients with CAP.

Further, many have argued obtaining routine blood cultures in CAP can have negative consequences. Blood cultures are relatively costly and time intensive, contaminated blood cultures can lead to repeated testing and increased length of stay, and delays in obtaining blood cultures can delay antibiotic administration, another important quality marker in CAP. For now, it remains the standard of care to obtain blood cultures in these patients, but hospitalists should be aware of the limitations of this practice and consider focusing on other clinical interventions and quality measures in CAP.

A Review Study: A Dyspneic Emergency Patient

Wang CS, FitzGerald JM, Schulzer M, et al. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294:944-1956.

Background: Distinguishing CHF from non-cardiac causes of dyspnea is a major challenge for hospitalists and emergency physicians, particularly in patients with a prior history of cardiac disease. Traditionally, clinicians have relied on the history, physical examination, and basic tests (chest X-ray and electrocardiogram) to diagnose CHF, but rapid B-type natriuretic peptide (BNP) testing is now widely incorporated as well.

A previous article in the Rational Clinical Examination series (Can the clinical examination diagnose left-sided heart failure in adults? JAMA. 1997;277(21):1712-1719) found that systolic dysfunction was moderately well predicted by an abnormal apical impulse on physical examination, radiographic cardiomegaly or venous redistribution, or electrocardiographic q waves or left bundle branch block.

Methods: In this review, the authors update and extend previous findings by also assessing the utility of serum BNP testing. The authors identified articles evaluating the diagnostic accuracy of the clinical exam and laboratory testing in diagnosing CHF in patients presenting to the emergency department with undifferentiated dyspnea. The “gold standard” was a clinical diagnosis of CHF made by the treating clinicians after an appropriate diagnostic workup. Summary likelihood ratios (LRs) were calculated using meta-analytic methodology.

Results/discussion: The authors determined that several findings increase the probability of CHF. A prior history of CHF (LR 5.8, CI 4.1-8.0) or myocardial infarction (LR 3.1, 95% CI 2.0-4.9), symptoms of paroxysmal nocturnal dyspnea (LR 2.6, 95% CI 1.5-4.5) and orthopnea (LR 2.2, 95% CI 1.2-3.9) were the most predictive historical factors. On physical examination, the presence of an S3 (LR 11, 95% CI 4.9-25), jugular venous distension (5.1, 95% CI 3.2-7.9), lung rales (LR 2.8, 95% CI 1.9-4.1), and peripheral edema (2.3, 95% CI 1.5-3.7) increased the probability of CHF. In interpreting these results, it is helpful to remember that a likelihood ratio of 2 increases the post-test probability by about 15%, and an LR of 5 increases the post-test probability by about 30%. Thus, a prior history of CHF and presence of an S3 or jugular venous distension are the most useful findings. Interestingly, clinician’s gestalt was equally predictive (LR 4.4, 95% CI 1.8-10.0.)

The most useful radiographic findings were venous congestion (LR 12.0, 95% CI 6.8-21) and the presence of cardiomegaly (LR 3.3; 95% CI 2.4-4.7). The single most predictive ECG finding was atrial fibrillation (LR 3.8; 95% CI 2.7-8.8); any abnormality on ECG had an LR of 2.2 (95% CI 1.6-3.1). Serum BNP levels were not more predictive of CHF than the history or physical examination; a BNP of >250 was associated with an LR of 4.6 (95% CI 2.6-8.0).

Few findings markedly decreased the probability of CHF. Here, it is helpful to remember that an LR of 0.5 decreases the post-test probability by about 15%, and an LR of 0.2 decreases the post-test probability by about 30%. With these in mind, the absence of cardiomegaly on CXR significantly changes the post-test probability (LR 0.33; 95% CI 0.23-0.48). A serum BNP level of less than 100pg/ml strongly argues against CHF, with an LR of 0.11 (95% CI 0.07-0.16); this finding lowers the post-test probability of CHF by about 45% compared to the pre-test probability.

In summary, the most useful findings for ruling in CHF in dyspneic emergency department patients were clinical gestalt, a prior history of CHF, findings of an S3 or jugular venous distension, and radiographic findings of venous congestion or cardiomegaly. Absence of radiographic cardiomegaly and a BNP of less than 100pg/ml argue against CHF. These must be interpreted in the context of the clinical pre-test probability of CHF, as none of the findings had likelihood ratios sufficient to be diagnostic of CHF when used individually.

What Should I Wear Today?

Rehman SU, Nietert PJ, Cope DW, Kilpatrick AO. What to wear today? Effect of doctor’s attire on the trust and confidence of patients. Am J Med. 2005 Nov; 118(11): 1279-1286.

Background: This study addresses the prototypical everyday clinical dilemma: What should I wear to work?

Methods: Patients and visitors to an outpatient Veterans Affairs internal medicine clinic in South Carolina were shown photographs of male and female physicians in four different styles of dress:

1. Professional (male physician wearing white coat with tie, female physician wearing white coat with tailored skirt or trousers);
2. Business (suit and tie for male, tailored trouser or skirt for female);
3. Surgical (surgical scrubs for both male and female): and
4. Casual (jeans and t-shirt or short skirt).

The study was randomized so that male and female respondents viewed photographs of either male or female physicians. Respondents were asked to report how strongly they felt about the importance of their physician’s appearance, and their preference for each style of dress; specifically, respondents were asked which physician was the most trustworthy, which physician they felt most comfortable with for routine examinations and emergencies, and which physician they felt most comfortable discussing psychological, sexual, and social problems with.

Results: Respondents overwhelmingly preferred professional attire for all questions: 76.3% felt most comfortable with a professionally dressed physician for all encounters, with surgical scrubs a distant second (10.2%), ahead of business dress (8.8%). Respondents were also significantly more willing to discuss psychological, sexual, and social problems with a professionally dressed physician. Even for care in an emergency situation, respondents still expressed a significant preference for professional attire over scrubs.

In a logistic regression model, patients who were older, African-American, and had less than a high school education were significantly more likely to prefer professional attire. Interestingly, female respondents who viewed photographs of female physicians placed significantly greater emphasis on physician’s attire than did male respondents.

Discussion: The study is clearly subject to caveats, chiefly that it was conducted at a single VA clinic and that only one aspect of the physician-patient encounter was addressed. Undoubtedly, patient’s preferences were influenced by the popular portrayal of physicians on TV shows. Nevertheless, given that hospitalists typically see older patients with whom they are not familiar, the initial clinical encounter may indeed by influenced by something as simple as wearing a white coat.

UA by Nephrologist Versus Hospital-Based Clinical Labs

Tsai JJ, Yeun JY, Kumar VA, Don BR. Comparison and interpretation of urinalysis performed by a nephrologist versus a hospital-based clinical laboratory. Am J Kidney Dis. 2005 Nov;46(5):820-829.

Background: Distinguishing the correct cause of acute renal failure is a frequent clinical dilemma for hospitalists, particularly diagnosing acute tubular necrosis (ATN), which is the most common cause of in-hospital acute renal failure. Although urinalysis with microscopy is the first test ordered on noting an abnormal serum creatinine, most hospitalists rely on the results generated by a laboratory technician. Anecdotally, many nephrologists have noted significant differences between urinalysis results performed by technicians and results found by nephrologists.

Methods: This study enrolled 26 patients hospitalized with acute renal failure on whom nephrology consultation was obtained. Urinalysis was performed both by laboratory personnel and a nephrologist (nephrologist A) who was blinded to the patient’s clinical information. Both sets of urinalysis results were independently used by nephrologist A and a second nephrologist (nephrologist B) to arrive at a clinical diagnosis for the patient, without having access to any other clinical information. These diagnoses were compared to the final diagnosis determined by the consulting nephrology service, who themselves did not have access to the diagnosis of either nephrologist A or B.

Results: The influence of having a nephrologist perform and interpret the urinalysis was striking. Nephrologist A was able to correctly diagnose 92.3% of cases based solely on his interpretation of the urinalysis. However, when given only the laboratory report of the urinalysis, both nephrologists were unable to diagnose most cases (23.1% for nephrologist A and 19.2% for nephrologist B). The major difference appeared to be in nephrologist A’s ability to find renal tubular epithelial (RTE) cells and RTE casts, which are pathognomonic of ATN. RTE cells and granular casts were frequently misinterpreted as squamous epithelial cells by laboratory personnel. This was particularly important as 81% of patients in the study had ATN as the primary cause of renal failure. Acanthocytes (dysmorphic red blood cells) were also missed by laboratory personnel in all six patients who were subsequently diagnosed with glomerulonephritis; nephrologist A correctly noted acanthocytes in five of these patients, and arrived at the correct diagnosis in all six patients.

Discussion: Microscopic evaluation of urine sediment has become a lost art among physicians, especially since passage of the Clinical Laboratory Improvement Amendments (CLIA) in 1988, which mandated that only CLIA-certified personnel could perform most laboratory tests. While it is probably unrealistic to call for training in microscopic urinalysis for all physicians, hospitalists in particular would benefit from such training, and at the very least should be mindful that laboratory urinalysis results may miss subtle findings that can be invaluable in diagnosing acute renal failure. This study points out the need for greater oversight and training of laboratory personnel, and serves as a reminder to clinicians that laboratory results should not be considered the gold standard. TH

Rothschild JM, Landrigan CP, Cronin JW, et al. The critical care safety study: the incidence and nature of adverse events and serious medical errors in intensive care. Crit Care Med. 2005;33:1694-1700.

Background: Critically ill patients require complex, immediate, high-intensity care, potentially placing them at increased risk of iatrogenic injury. The frequency and nature of adverse events and errors in the modern ICU have not been clearly defined.

Methods: Harvard researchers conducted a prospective, one-year, observational study of a MICU and a CCU at a tertiary care medical center. Adverse events and medical errors were identified by a four-pronged approach: direct 24-hour observation of interns, voluntary incident reporting, a computerized adverse drug event monitoring system, and chart abstraction. Two physicians independently assessed the type, severity, and preventability of the incidents.

Results: A total of 391 patients comprising 1,490 patient-days were observed and included. Twenty percent of all patients suffered an adverse event, 45% of which were preventable and 13% of which were felt to be life-threatening. There were 223 serious errors (those that caused harm or had the potential to cause harm) observed of which 11% were life threatening. Medication adverse events and medication errors accounted for a large proportion of the incidents during the study. Slips and lapses in care were much more common than rule-based (such as using the wrong protocol) or knowledge-based mistakes.

Discussion: Since the Institute of Medicine report in 1999, there has been an increasing focus on patient safety in the inpatient setting. Based on the results of this study and others, it appears the high-intensity, fast-paced nature of critical care places patients at substantial risk for iatrogenic injury. Up to 20% of patients admitted to the ICU in this study suffered an adverse event or a medical error, which translates into 0.8 adverse events and 1.5 serious medical errors per day in a 10-bed ICU.

Because failure to carry out intended plans (usually secondary to slips and lapses on the part of healthcare providers) was the most common cause of adverse events and errors, the authors address possible solutions. They propose employing computerized-order entry, clinical pharmacists in the ICU, closed ICU staffing, “smart” intravenous pumps, and improved teamwork and communication among healthcare providers. Hospitalists often manage critically ill patients and should be aware of the high risk of medical errors and should consider implementing specific systems changes to mitigate the risk.

The Value of Obtaining Blood Cultures in Pneumonia Pts

Kennedy M, Bates DW, Wright SB, et al. Do emergency department blood cultures change practice in patients with pneumonia? Ann Emerg Med. 2005 Nov;46(5):393-400.

Background: Previous observational studies in patients hospitalized with community-acquired pneumonia (CAP) have shown obtaining blood cultures may have a mortality benefit. This practice has become expert guideline-recommended, the standard of care, as well as a quality marker in the management of CAP. Several recent studies have questioned the utility and cost-effectiveness of this practice.

Methods: Harvard researchers performed a prospective, observational, cohort study of adults admitted to an urban university medical center. Researchers identified patients who had all of the following: clinical CAP, radiographic CAP, and blood cultures at admission. Blood cultures were classified as positive, negative, or contaminated based on previously established criteria. Data were collected on antimicrobial sensitivities, empiric antibiotic choices, and antibiotic changes.

Results: In one year, 414 patients with clinical and radiographic CAP had blood cultures at the time of admission. Twenty-nine of 414 (7%) of patients had true bacteremia while 25 of 414 (6%) had contaminants. Antibiotic therapy was altered in response to blood culture results in 15 of 414 patients (3.6%), of which 11 (2.7%) had therapy narrowed and four (1.0%) had therapy broadened. Of the 11 patients with bacteremia whose therapy was not changed, culture results supported narrowing therapy in eight cases but this was not done.

Discussion: This well done prospective observational study adds to a growing body of evidence questioning the utility of routine blood cultures on all patients hospitalized with CAP. The argument traditionally has been made that blood cultures allow clinicians to narrow or broaden antibiotics based on sensitivities. Yet, empiric therapy was broadened in response to bacteremia in only a small fraction of patients (1%) and in only 11 of 19 patients was therapy appropriately narrowed based on the blood cultures. The study did not measure the impact of blood cultures on clinical outcomes, but these striking results reveal that routine blood cultures rarely alter our management of hospitalized patients with CAP.

Further, many have argued obtaining routine blood cultures in CAP can have negative consequences. Blood cultures are relatively costly and time intensive, contaminated blood cultures can lead to repeated testing and increased length of stay, and delays in obtaining blood cultures can delay antibiotic administration, another important quality marker in CAP. For now, it remains the standard of care to obtain blood cultures in these patients, but hospitalists should be aware of the limitations of this practice and consider focusing on other clinical interventions and quality measures in CAP.

A Review Study: A Dyspneic Emergency Patient

Wang CS, FitzGerald JM, Schulzer M, et al. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294:944-1956.

Background: Distinguishing CHF from non-cardiac causes of dyspnea is a major challenge for hospitalists and emergency physicians, particularly in patients with a prior history of cardiac disease. Traditionally, clinicians have relied on the history, physical examination, and basic tests (chest X-ray and electrocardiogram) to diagnose CHF, but rapid B-type natriuretic peptide (BNP) testing is now widely incorporated as well.

A previous article in the Rational Clinical Examination series (Can the clinical examination diagnose left-sided heart failure in adults? JAMA. 1997;277(21):1712-1719) found that systolic dysfunction was moderately well predicted by an abnormal apical impulse on physical examination, radiographic cardiomegaly or venous redistribution, or electrocardiographic q waves or left bundle branch block.

Methods: In this review, the authors update and extend previous findings by also assessing the utility of serum BNP testing. The authors identified articles evaluating the diagnostic accuracy of the clinical exam and laboratory testing in diagnosing CHF in patients presenting to the emergency department with undifferentiated dyspnea. The “gold standard” was a clinical diagnosis of CHF made by the treating clinicians after an appropriate diagnostic workup. Summary likelihood ratios (LRs) were calculated using meta-analytic methodology.

Results/discussion: The authors determined that several findings increase the probability of CHF. A prior history of CHF (LR 5.8, CI 4.1-8.0) or myocardial infarction (LR 3.1, 95% CI 2.0-4.9), symptoms of paroxysmal nocturnal dyspnea (LR 2.6, 95% CI 1.5-4.5) and orthopnea (LR 2.2, 95% CI 1.2-3.9) were the most predictive historical factors. On physical examination, the presence of an S3 (LR 11, 95% CI 4.9-25), jugular venous distension (5.1, 95% CI 3.2-7.9), lung rales (LR 2.8, 95% CI 1.9-4.1), and peripheral edema (2.3, 95% CI 1.5-3.7) increased the probability of CHF. In interpreting these results, it is helpful to remember that a likelihood ratio of 2 increases the post-test probability by about 15%, and an LR of 5 increases the post-test probability by about 30%. Thus, a prior history of CHF and presence of an S3 or jugular venous distension are the most useful findings. Interestingly, clinician’s gestalt was equally predictive (LR 4.4, 95% CI 1.8-10.0.)

The most useful radiographic findings were venous congestion (LR 12.0, 95% CI 6.8-21) and the presence of cardiomegaly (LR 3.3; 95% CI 2.4-4.7). The single most predictive ECG finding was atrial fibrillation (LR 3.8; 95% CI 2.7-8.8); any abnormality on ECG had an LR of 2.2 (95% CI 1.6-3.1). Serum BNP levels were not more predictive of CHF than the history or physical examination; a BNP of >250 was associated with an LR of 4.6 (95% CI 2.6-8.0).

Few findings markedly decreased the probability of CHF. Here, it is helpful to remember that an LR of 0.5 decreases the post-test probability by about 15%, and an LR of 0.2 decreases the post-test probability by about 30%. With these in mind, the absence of cardiomegaly on CXR significantly changes the post-test probability (LR 0.33; 95% CI 0.23-0.48). A serum BNP level of less than 100pg/ml strongly argues against CHF, with an LR of 0.11 (95% CI 0.07-0.16); this finding lowers the post-test probability of CHF by about 45% compared to the pre-test probability.

In summary, the most useful findings for ruling in CHF in dyspneic emergency department patients were clinical gestalt, a prior history of CHF, findings of an S3 or jugular venous distension, and radiographic findings of venous congestion or cardiomegaly. Absence of radiographic cardiomegaly and a BNP of less than 100pg/ml argue against CHF. These must be interpreted in the context of the clinical pre-test probability of CHF, as none of the findings had likelihood ratios sufficient to be diagnostic of CHF when used individually.

What Should I Wear Today?

Rehman SU, Nietert PJ, Cope DW, Kilpatrick AO. What to wear today? Effect of doctor’s attire on the trust and confidence of patients. Am J Med. 2005 Nov; 118(11): 1279-1286.

Background: This study addresses the prototypical everyday clinical dilemma: What should I wear to work?

Methods: Patients and visitors to an outpatient Veterans Affairs internal medicine clinic in South Carolina were shown photographs of male and female physicians in four different styles of dress:

1. Professional (male physician wearing white coat with tie, female physician wearing white coat with tailored skirt or trousers);
2. Business (suit and tie for male, tailored trouser or skirt for female);
3. Surgical (surgical scrubs for both male and female): and
4. Casual (jeans and t-shirt or short skirt).

The study was randomized so that male and female respondents viewed photographs of either male or female physicians. Respondents were asked to report how strongly they felt about the importance of their physician’s appearance, and their preference for each style of dress; specifically, respondents were asked which physician was the most trustworthy, which physician they felt most comfortable with for routine examinations and emergencies, and which physician they felt most comfortable discussing psychological, sexual, and social problems with.

Results: Respondents overwhelmingly preferred professional attire for all questions: 76.3% felt most comfortable with a professionally dressed physician for all encounters, with surgical scrubs a distant second (10.2%), ahead of business dress (8.8%). Respondents were also significantly more willing to discuss psychological, sexual, and social problems with a professionally dressed physician. Even for care in an emergency situation, respondents still expressed a significant preference for professional attire over scrubs.

In a logistic regression model, patients who were older, African-American, and had less than a high school education were significantly more likely to prefer professional attire. Interestingly, female respondents who viewed photographs of female physicians placed significantly greater emphasis on physician’s attire than did male respondents.

Discussion: The study is clearly subject to caveats, chiefly that it was conducted at a single VA clinic and that only one aspect of the physician-patient encounter was addressed. Undoubtedly, patient’s preferences were influenced by the popular portrayal of physicians on TV shows. Nevertheless, given that hospitalists typically see older patients with whom they are not familiar, the initial clinical encounter may indeed by influenced by something as simple as wearing a white coat.

UA by Nephrologist Versus Hospital-Based Clinical Labs

Tsai JJ, Yeun JY, Kumar VA, Don BR. Comparison and interpretation of urinalysis performed by a nephrologist versus a hospital-based clinical laboratory. Am J Kidney Dis. 2005 Nov;46(5):820-829.

Background: Distinguishing the correct cause of acute renal failure is a frequent clinical dilemma for hospitalists, particularly diagnosing acute tubular necrosis (ATN), which is the most common cause of in-hospital acute renal failure. Although urinalysis with microscopy is the first test ordered on noting an abnormal serum creatinine, most hospitalists rely on the results generated by a laboratory technician. Anecdotally, many nephrologists have noted significant differences between urinalysis results performed by technicians and results found by nephrologists.

Methods: This study enrolled 26 patients hospitalized with acute renal failure on whom nephrology consultation was obtained. Urinalysis was performed both by laboratory personnel and a nephrologist (nephrologist A) who was blinded to the patient’s clinical information. Both sets of urinalysis results were independently used by nephrologist A and a second nephrologist (nephrologist B) to arrive at a clinical diagnosis for the patient, without having access to any other clinical information. These diagnoses were compared to the final diagnosis determined by the consulting nephrology service, who themselves did not have access to the diagnosis of either nephrologist A or B.

Results: The influence of having a nephrologist perform and interpret the urinalysis was striking. Nephrologist A was able to correctly diagnose 92.3% of cases based solely on his interpretation of the urinalysis. However, when given only the laboratory report of the urinalysis, both nephrologists were unable to diagnose most cases (23.1% for nephrologist A and 19.2% for nephrologist B). The major difference appeared to be in nephrologist A’s ability to find renal tubular epithelial (RTE) cells and RTE casts, which are pathognomonic of ATN. RTE cells and granular casts were frequently misinterpreted as squamous epithelial cells by laboratory personnel. This was particularly important as 81% of patients in the study had ATN as the primary cause of renal failure. Acanthocytes (dysmorphic red blood cells) were also missed by laboratory personnel in all six patients who were subsequently diagnosed with glomerulonephritis; nephrologist A correctly noted acanthocytes in five of these patients, and arrived at the correct diagnosis in all six patients.

Discussion: Microscopic evaluation of urine sediment has become a lost art among physicians, especially since passage of the Clinical Laboratory Improvement Amendments (CLIA) in 1988, which mandated that only CLIA-certified personnel could perform most laboratory tests. While it is probably unrealistic to call for training in microscopic urinalysis for all physicians, hospitalists in particular would benefit from such training, and at the very least should be mindful that laboratory urinalysis results may miss subtle findings that can be invaluable in diagnosing acute renal failure. This study points out the need for greater oversight and training of laboratory personnel, and serves as a reminder to clinicians that laboratory results should not be considered the gold standard. TH

Major Jason Stamm

Editors’ note: During 2006 we will publish coverage of hospital practices in other countries. This and the article on Africa (p. 26) are the third and fourth articles in that effort.

The sound of helicopters, the sight of concrete blast barriers and of sandbags, and the smell of smoke were the first impressions I had upon arriving at Balad Air Base, Iraq. I am a military physician used to working in a clean, safe, predictable hospital environment when I arrived in Iraq on my first deployment to a combat zone. Few military doctors arrive at Balad with extensive training in combat medicine even though that is our primary mission. Through teamwork and the varied talents of different backgrounds, we provide excellent care to American, coalition, and Iraqi patients. An internist by training and practice, I share my experiences as a member of that combat medicine team.

At one time the Iraqi Air Force Academy, Balad Air Base is approximately 40 miles north of Baghdad near the Tigris River in the heart of the “Sunni Triangle.” The Air Force Theater Hospital (AFTH)—one of several expeditionary hospitals in the Iraqi theater—is located at Balad Air Base. Although Air Force in name, the hospital is truly a joint mission, with medical staff from both the U.S Army and Air Force working side by side. The hospital is robust in capability, but is not permanent in nature.

Hospital Structure

The hospital functions out of a multitude of large tents joined in tandem. Although climate controlled, the tents provide only a minimal barrier to dust and noise, and keeping the area clean and speaking in normal tones is a constant struggle. Like hospitals in the United States, there are distinct units within the AFTH: an emergency department, operating rooms, an ICU, a general medicine and surgical ward unit, a pharmacy, a clinical laboratory, and a radiology section.

The Patients

Patients arrive at AFTH either directly from the field or, after initial triage and stabilization, or from smaller treatment facilities. AFTH is primarily a trauma center, and the majority of patients arrive via helicopter given the need for rapid movement and the danger inherent in vehicular transport. The sound of helicopter rotors is omnipresent at AFTH. The proximity of the landing pad to the hospital results in one of the impressions of Balad that I will not soon forget: that of the conversation-deafening and air-reverberating arrival of new patients.

The majority of patients who arrive at AFTH have sustained some type of combat-related injury, usually gunshot or improvised-explosive device (IED) wounds. These patients are initially assessed by emergency medicine physicians and surgeons. Many of the patients go immediately to the operating room for wound management, and those who require a higher level of care (either pre- or post-operatively) are moved to the ICU.

As an internist, my role is as a member of the ICU team of physicians that cares for these critically ill patients. The physicians who comprise the ICU team have different backgrounds, including general surgery, internal medicine, anesthesiology, emergency medicine, and subspecialties (currently a general internist, a medicine intensivist, a cardiologist, and an infectious disease doctor).

The goal of the ICU team is to provide for continuity of care of these critically ill patients during their ICU stay and to ensure that other AFTH staff members—most notably surgeons—can concentrate on new patients as they arrive. In addition to caring for critically ill trauma patients, my fellow internists and I also function much as we do at home: evaluating and admitting patients from the emergency department whose conditions are traditionally managed by internal medicine, including acute coronary syndromes, diabetic ketoacidosis, syncope, and gastrointestinal bleeding, to name a recent few.

Major Jason Stamm

How I Spend My Time

Apart from the caring for the occasional internal medicine patient, I spend the majority of my time working outside of the usual realm of the internist. In the noisy combat hospital, conventional internal medicine patient evaluations are impossible. The history is often limited by the patient’s physical condition and, for many of the Iraqi soldiers, a language barrier. Physical exams are done more with sight and touch than with a stethoscope. The past medical and surgical history is uncertain. The knowledge and skills required to care for these trauma patients are also a departure from routine internal medicine practice.

Fortunately, I discovered that, although little used since residency, my ability to manage ventilators and to perform invasive procedures was quick to return and was immediately put into practice. I have learned aspects of critical care as practiced in the theater hospital ICU that I was unfamiliar with initially—such as the intricacies of post-operative and trauma care—on the job. I have become familiar with dressings, drains, and the concepts of resuscitation and of “secondary survey.” I have acquired a working knowledge of the various types of surgical procedures performed, and the subsequent care required thereof, in trauma patients. I have become familiar with treating elevated intracranial pressure in patients who have had craniotomies for penetrating brain injuries, with monitoring airway pressures and oxygenation in patients with blast-related pulmonary contusions, with following bladder pressures and serial exams in patients with abdominal trauma, and with managing chest tubes in patients with penetrating thoracic injuries.

I have even overcome a reluctance shared by many in internal medicine and have learned to look under surgical bandages—a feat that may undermine the truth that gives rise to the joke about hiding something from internists. Perhaps the most important concept I have learned in caring for combat trauma patients in the ICU is vigilance.

The primary survey, completed by the emergency medicine and trauma surgeons, usually discovers and addresses the large or obvious wounds that bring patients to our facility. When the patients arrive in the ICU after having their initial resuscitation and “damage control” operative intervention, it falls to the intensive care physician to both continue resuscitation and to look for as yet undiagnosed or delayed injury presentations. This constitutes the secondary survey and is an ongoing process. Patients often arrive in the ICU still recovering from their injuries; they require close attention to physiologic parameters such as temperature, heart rate, arterial pressure, and urine output. Their laboratory measurements, including oxygenation and ventilation, acid-base status (e.g., a reliance on the base excess, a tool more familiar to those in surgery than in medicine), hemoglobin concentration, and indices of coagulation, require constant attention.

In addition, patients often come to the ICU with vascular lines that were placed in the field under less than sterile conditions and require replacement. While major wounds have usually been addressed, minor wounds (such as missed fragments of shrapnel and subtle vascular injuries) or delayed presentations (including blast injuries and compartment syndromes) must be identified in the ICU and mandate constant awareness.

Specific Challenges

There are challenges, both personally and professionally, to working in a combat zone. Like everyone here, I am away from family and home for an extended time. Although fairly secure, one’s personal safety from ongoing mortar attacks is also an emotional burden. The hours are long and the recreational opportunities are limited on base. Traveling off base is strictly limited for obvious security reasons and most hospital personnel spend their entire tour in Iraq within the confines of the base perimeter.

Professionally, the biggest challenge to working at the AFTH is our location and resultant long supply train. Almost every item needed to stock a modern hospital comes not from the local economy but from outside the country and must be either flown or trucked in. This logistic trail requires constant attention to efficiency and inventory and when supplies are out or equipment is down, sometimes we must resort to ingenuity. We try to do the best we can for every individual yet, akin to the concept of military triage, we must use our medical resources with the utilitarian philosophy of “the greatest good for the greatest number.”

Final Thoughts

Practicing medicine at AFTH has been, for me, the opportunity of a lifetime. I work with very talented people, learn an amazing amount, and—most importantly—help care for our men and women in uniform. Although we practice medicine much differently from the way we do at home, the adjustment to the combat hospital is facilitated by the close teamwork among physicians here. This is exemplified in the ICU, where twice daily ICU rounds are led by a surgical intensivist and are attended by general surgeons, surgical subspecialists, and the ICU team, including internists and medicine subspecialists. In how many medical facilities do surgeons and internists, caring for the same patients, perform bedside rounds together as a matter of routine?

I believe this sense of teamwork exists in the combat zone for several reasons, including necessity, in which efficient use of time and manpower is critical, and of fluidity, in which the constant mixing and turnover of hospital staff prevents departmental barriers from developing. Perhaps the most important reason teamwork flourishes at AFTH is the overarching sense of mission in an austere environment. We are at Balad Air Base primarily to care for wounded American and Iraqi military members, and that responsibility under these conditions requires a resourceful and collaborative approach to the practice of medicine. TH

The views expressed herein are those of the author and do not represent the opinions of the U.S. Government, the U.S. Department of Defense, or the U.S. Air Force.

Major Jason Stamm

Editors’ note: During 2006 we will publish coverage of hospital practices in other countries. This and the article on Africa (p. 26) are the third and fourth articles in that effort.

The sound of helicopters, the sight of concrete blast barriers and of sandbags, and the smell of smoke were the first impressions I had upon arriving at Balad Air Base, Iraq. I am a military physician used to working in a clean, safe, predictable hospital environment when I arrived in Iraq on my first deployment to a combat zone. Few military doctors arrive at Balad with extensive training in combat medicine even though that is our primary mission. Through teamwork and the varied talents of different backgrounds, we provide excellent care to American, coalition, and Iraqi patients. An internist by training and practice, I share my experiences as a member of that combat medicine team.

At one time the Iraqi Air Force Academy, Balad Air Base is approximately 40 miles north of Baghdad near the Tigris River in the heart of the “Sunni Triangle.” The Air Force Theater Hospital (AFTH)—one of several expeditionary hospitals in the Iraqi theater—is located at Balad Air Base. Although Air Force in name, the hospital is truly a joint mission, with medical staff from both the U.S Army and Air Force working side by side. The hospital is robust in capability, but is not permanent in nature.

Hospital Structure

The hospital functions out of a multitude of large tents joined in tandem. Although climate controlled, the tents provide only a minimal barrier to dust and noise, and keeping the area clean and speaking in normal tones is a constant struggle. Like hospitals in the United States, there are distinct units within the AFTH: an emergency department, operating rooms, an ICU, a general medicine and surgical ward unit, a pharmacy, a clinical laboratory, and a radiology section.

The Patients

Patients arrive at AFTH either directly from the field or, after initial triage and stabilization, or from smaller treatment facilities. AFTH is primarily a trauma center, and the majority of patients arrive via helicopter given the need for rapid movement and the danger inherent in vehicular transport. The sound of helicopter rotors is omnipresent at AFTH. The proximity of the landing pad to the hospital results in one of the impressions of Balad that I will not soon forget: that of the conversation-deafening and air-reverberating arrival of new patients.

The majority of patients who arrive at AFTH have sustained some type of combat-related injury, usually gunshot or improvised-explosive device (IED) wounds. These patients are initially assessed by emergency medicine physicians and surgeons. Many of the patients go immediately to the operating room for wound management, and those who require a higher level of care (either pre- or post-operatively) are moved to the ICU.

As an internist, my role is as a member of the ICU team of physicians that cares for these critically ill patients. The physicians who comprise the ICU team have different backgrounds, including general surgery, internal medicine, anesthesiology, emergency medicine, and subspecialties (currently a general internist, a medicine intensivist, a cardiologist, and an infectious disease doctor).

The goal of the ICU team is to provide for continuity of care of these critically ill patients during their ICU stay and to ensure that other AFTH staff members—most notably surgeons—can concentrate on new patients as they arrive. In addition to caring for critically ill trauma patients, my fellow internists and I also function much as we do at home: evaluating and admitting patients from the emergency department whose conditions are traditionally managed by internal medicine, including acute coronary syndromes, diabetic ketoacidosis, syncope, and gastrointestinal bleeding, to name a recent few.

Major Jason Stamm

How I Spend My Time

Apart from the caring for the occasional internal medicine patient, I spend the majority of my time working outside of the usual realm of the internist. In the noisy combat hospital, conventional internal medicine patient evaluations are impossible. The history is often limited by the patient’s physical condition and, for many of the Iraqi soldiers, a language barrier. Physical exams are done more with sight and touch than with a stethoscope. The past medical and surgical history is uncertain. The knowledge and skills required to care for these trauma patients are also a departure from routine internal medicine practice.

Fortunately, I discovered that, although little used since residency, my ability to manage ventilators and to perform invasive procedures was quick to return and was immediately put into practice. I have learned aspects of critical care as practiced in the theater hospital ICU that I was unfamiliar with initially—such as the intricacies of post-operative and trauma care—on the job. I have become familiar with dressings, drains, and the concepts of resuscitation and of “secondary survey.” I have acquired a working knowledge of the various types of surgical procedures performed, and the subsequent care required thereof, in trauma patients. I have become familiar with treating elevated intracranial pressure in patients who have had craniotomies for penetrating brain injuries, with monitoring airway pressures and oxygenation in patients with blast-related pulmonary contusions, with following bladder pressures and serial exams in patients with abdominal trauma, and with managing chest tubes in patients with penetrating thoracic injuries.

I have even overcome a reluctance shared by many in internal medicine and have learned to look under surgical bandages—a feat that may undermine the truth that gives rise to the joke about hiding something from internists. Perhaps the most important concept I have learned in caring for combat trauma patients in the ICU is vigilance.

The primary survey, completed by the emergency medicine and trauma surgeons, usually discovers and addresses the large or obvious wounds that bring patients to our facility. When the patients arrive in the ICU after having their initial resuscitation and “damage control” operative intervention, it falls to the intensive care physician to both continue resuscitation and to look for as yet undiagnosed or delayed injury presentations. This constitutes the secondary survey and is an ongoing process. Patients often arrive in the ICU still recovering from their injuries; they require close attention to physiologic parameters such as temperature, heart rate, arterial pressure, and urine output. Their laboratory measurements, including oxygenation and ventilation, acid-base status (e.g., a reliance on the base excess, a tool more familiar to those in surgery than in medicine), hemoglobin concentration, and indices of coagulation, require constant attention.

In addition, patients often come to the ICU with vascular lines that were placed in the field under less than sterile conditions and require replacement. While major wounds have usually been addressed, minor wounds (such as missed fragments of shrapnel and subtle vascular injuries) or delayed presentations (including blast injuries and compartment syndromes) must be identified in the ICU and mandate constant awareness.

Specific Challenges

There are challenges, both personally and professionally, to working in a combat zone. Like everyone here, I am away from family and home for an extended time. Although fairly secure, one’s personal safety from ongoing mortar attacks is also an emotional burden. The hours are long and the recreational opportunities are limited on base. Traveling off base is strictly limited for obvious security reasons and most hospital personnel spend their entire tour in Iraq within the confines of the base perimeter.

Professionally, the biggest challenge to working at the AFTH is our location and resultant long supply train. Almost every item needed to stock a modern hospital comes not from the local economy but from outside the country and must be either flown or trucked in. This logistic trail requires constant attention to efficiency and inventory and when supplies are out or equipment is down, sometimes we must resort to ingenuity. We try to do the best we can for every individual yet, akin to the concept of military triage, we must use our medical resources with the utilitarian philosophy of “the greatest good for the greatest number.”

Final Thoughts

Practicing medicine at AFTH has been, for me, the opportunity of a lifetime. I work with very talented people, learn an amazing amount, and—most importantly—help care for our men and women in uniform. Although we practice medicine much differently from the way we do at home, the adjustment to the combat hospital is facilitated by the close teamwork among physicians here. This is exemplified in the ICU, where twice daily ICU rounds are led by a surgical intensivist and are attended by general surgeons, surgical subspecialists, and the ICU team, including internists and medicine subspecialists. In how many medical facilities do surgeons and internists, caring for the same patients, perform bedside rounds together as a matter of routine?

I believe this sense of teamwork exists in the combat zone for several reasons, including necessity, in which efficient use of time and manpower is critical, and of fluidity, in which the constant mixing and turnover of hospital staff prevents departmental barriers from developing. Perhaps the most important reason teamwork flourishes at AFTH is the overarching sense of mission in an austere environment. We are at Balad Air Base primarily to care for wounded American and Iraqi military members, and that responsibility under these conditions requires a resourceful and collaborative approach to the practice of medicine. TH

The views expressed herein are those of the author and do not represent the opinions of the U.S. Government, the U.S. Department of Defense, or the U.S. Air Force.

Major Jason Stamm

Editors’ note: During 2006 we will publish coverage of hospital practices in other countries. This and the article on Africa (p. 26) are the third and fourth articles in that effort.

The sound of helicopters, the sight of concrete blast barriers and of sandbags, and the smell of smoke were the first impressions I had upon arriving at Balad Air Base, Iraq. I am a military physician used to working in a clean, safe, predictable hospital environment when I arrived in Iraq on my first deployment to a combat zone. Few military doctors arrive at Balad with extensive training in combat medicine even though that is our primary mission. Through teamwork and the varied talents of different backgrounds, we provide excellent care to American, coalition, and Iraqi patients. An internist by training and practice, I share my experiences as a member of that combat medicine team.

At one time the Iraqi Air Force Academy, Balad Air Base is approximately 40 miles north of Baghdad near the Tigris River in the heart of the “Sunni Triangle.” The Air Force Theater Hospital (AFTH)—one of several expeditionary hospitals in the Iraqi theater—is located at Balad Air Base. Although Air Force in name, the hospital is truly a joint mission, with medical staff from both the U.S Army and Air Force working side by side. The hospital is robust in capability, but is not permanent in nature.

Hospital Structure

The hospital functions out of a multitude of large tents joined in tandem. Although climate controlled, the tents provide only a minimal barrier to dust and noise, and keeping the area clean and speaking in normal tones is a constant struggle. Like hospitals in the United States, there are distinct units within the AFTH: an emergency department, operating rooms, an ICU, a general medicine and surgical ward unit, a pharmacy, a clinical laboratory, and a radiology section.

The Patients

Patients arrive at AFTH either directly from the field or, after initial triage and stabilization, or from smaller treatment facilities. AFTH is primarily a trauma center, and the majority of patients arrive via helicopter given the need for rapid movement and the danger inherent in vehicular transport. The sound of helicopter rotors is omnipresent at AFTH. The proximity of the landing pad to the hospital results in one of the impressions of Balad that I will not soon forget: that of the conversation-deafening and air-reverberating arrival of new patients.

The majority of patients who arrive at AFTH have sustained some type of combat-related injury, usually gunshot or improvised-explosive device (IED) wounds. These patients are initially assessed by emergency medicine physicians and surgeons. Many of the patients go immediately to the operating room for wound management, and those who require a higher level of care (either pre- or post-operatively) are moved to the ICU.

As an internist, my role is as a member of the ICU team of physicians that cares for these critically ill patients. The physicians who comprise the ICU team have different backgrounds, including general surgery, internal medicine, anesthesiology, emergency medicine, and subspecialties (currently a general internist, a medicine intensivist, a cardiologist, and an infectious disease doctor).

The goal of the ICU team is to provide for continuity of care of these critically ill patients during their ICU stay and to ensure that other AFTH staff members—most notably surgeons—can concentrate on new patients as they arrive. In addition to caring for critically ill trauma patients, my fellow internists and I also function much as we do at home: evaluating and admitting patients from the emergency department whose conditions are traditionally managed by internal medicine, including acute coronary syndromes, diabetic ketoacidosis, syncope, and gastrointestinal bleeding, to name a recent few.

Major Jason Stamm

How I Spend My Time

Apart from the caring for the occasional internal medicine patient, I spend the majority of my time working outside of the usual realm of the internist. In the noisy combat hospital, conventional internal medicine patient evaluations are impossible. The history is often limited by the patient’s physical condition and, for many of the Iraqi soldiers, a language barrier. Physical exams are done more with sight and touch than with a stethoscope. The past medical and surgical history is uncertain. The knowledge and skills required to care for these trauma patients are also a departure from routine internal medicine practice.

Fortunately, I discovered that, although little used since residency, my ability to manage ventilators and to perform invasive procedures was quick to return and was immediately put into practice. I have learned aspects of critical care as practiced in the theater hospital ICU that I was unfamiliar with initially—such as the intricacies of post-operative and trauma care—on the job. I have become familiar with dressings, drains, and the concepts of resuscitation and of “secondary survey.” I have acquired a working knowledge of the various types of surgical procedures performed, and the subsequent care required thereof, in trauma patients. I have become familiar with treating elevated intracranial pressure in patients who have had craniotomies for penetrating brain injuries, with monitoring airway pressures and oxygenation in patients with blast-related pulmonary contusions, with following bladder pressures and serial exams in patients with abdominal trauma, and with managing chest tubes in patients with penetrating thoracic injuries.

I have even overcome a reluctance shared by many in internal medicine and have learned to look under surgical bandages—a feat that may undermine the truth that gives rise to the joke about hiding something from internists. Perhaps the most important concept I have learned in caring for combat trauma patients in the ICU is vigilance.

The primary survey, completed by the emergency medicine and trauma surgeons, usually discovers and addresses the large or obvious wounds that bring patients to our facility. When the patients arrive in the ICU after having their initial resuscitation and “damage control” operative intervention, it falls to the intensive care physician to both continue resuscitation and to look for as yet undiagnosed or delayed injury presentations. This constitutes the secondary survey and is an ongoing process. Patients often arrive in the ICU still recovering from their injuries; they require close attention to physiologic parameters such as temperature, heart rate, arterial pressure, and urine output. Their laboratory measurements, including oxygenation and ventilation, acid-base status (e.g., a reliance on the base excess, a tool more familiar to those in surgery than in medicine), hemoglobin concentration, and indices of coagulation, require constant attention.

In addition, patients often come to the ICU with vascular lines that were placed in the field under less than sterile conditions and require replacement. While major wounds have usually been addressed, minor wounds (such as missed fragments of shrapnel and subtle vascular injuries) or delayed presentations (including blast injuries and compartment syndromes) must be identified in the ICU and mandate constant awareness.

Specific Challenges

There are challenges, both personally and professionally, to working in a combat zone. Like everyone here, I am away from family and home for an extended time. Although fairly secure, one’s personal safety from ongoing mortar attacks is also an emotional burden. The hours are long and the recreational opportunities are limited on base. Traveling off base is strictly limited for obvious security reasons and most hospital personnel spend their entire tour in Iraq within the confines of the base perimeter.

Professionally, the biggest challenge to working at the AFTH is our location and resultant long supply train. Almost every item needed to stock a modern hospital comes not from the local economy but from outside the country and must be either flown or trucked in. This logistic trail requires constant attention to efficiency and inventory and when supplies are out or equipment is down, sometimes we must resort to ingenuity. We try to do the best we can for every individual yet, akin to the concept of military triage, we must use our medical resources with the utilitarian philosophy of “the greatest good for the greatest number.”

Final Thoughts

Practicing medicine at AFTH has been, for me, the opportunity of a lifetime. I work with very talented people, learn an amazing amount, and—most importantly—help care for our men and women in uniform. Although we practice medicine much differently from the way we do at home, the adjustment to the combat hospital is facilitated by the close teamwork among physicians here. This is exemplified in the ICU, where twice daily ICU rounds are led by a surgical intensivist and are attended by general surgeons, surgical subspecialists, and the ICU team, including internists and medicine subspecialists. In how many medical facilities do surgeons and internists, caring for the same patients, perform bedside rounds together as a matter of routine?

I believe this sense of teamwork exists in the combat zone for several reasons, including necessity, in which efficient use of time and manpower is critical, and of fluidity, in which the constant mixing and turnover of hospital staff prevents departmental barriers from developing. Perhaps the most important reason teamwork flourishes at AFTH is the overarching sense of mission in an austere environment. We are at Balad Air Base primarily to care for wounded American and Iraqi military members, and that responsibility under these conditions requires a resourceful and collaborative approach to the practice of medicine. TH

The views expressed herein are those of the author and do not represent the opinions of the U.S. Government, the U.S. Department of Defense, or the U.S. Air Force.

Editors’ note: During 2006 we will publish coverage of hospital practices in other countries. This and the article on Iraq (p. 28) are the third and fourth articles in that effort.

At the Ontario Hospital Association’s (OHA) CEO Forum in September 2003, Stephen Lewis, the United Nations Secretary General’s Special Envoy for HIV/AIDS in Africa, challenged Ontario’s hospital leaders to take a leadership role in the fight to treat and prevent the spread of HIV/AIDS in sub-Saharan Africa. Lewis’ compelling words evoked an outpouring of interest on the part of Ontario’s healthcare and hospital community, culminating in the launch of the OHAfrica Project in 2004 by the OHA and its affiliated health research foundation, The Change Foundation.

OHAfrica supports a small team of Ontario healthcare professionals working at the first public HIV/AIDS treatment center in the southern African country of Lesotho. The Tsepong “Place of Hope” Clinic is located in the town of Leribe. The Canadian team includes two physicians, one nurse practitioner, one registered nurse, one pharmacist, and one program administrator—all working alongside a small number of local staff.

The landlocked country of Lesotho was chosen at Lewis’ recommendation. The southern African Kingdom of Lesotho was selected as the focus of the OHAfrica project. Close to 30% of all Basotho people between ages 15 and 49 are infected with HIV, and Lesotho has the fourth-highest HIV prevalence rate in the world. More than 100,000 children have been orphaned by HIV/AIDS, and approximately 29,000 people in Lesotho die of AIDS every year.

Since OHAfrica was launched on World AIDS Day in December 2004 the project has accomplished a great deal. The Tsepong Clinic has become the largest antiretroviral (ARV) treatment center in the country, and the clinic enrolls more than half of all new patients put on ARVs in Lesotho each month.

Until recently, antiretroviral drugs were beyond the means of most people in Africa, costing between $12,000 and $15,000 per year. With newly available generic drugs, the cost to provide one person in Lesotho with ARV treatment for one year is now approximately $140—less than .40 cents per day.

The ARV drugs available at the Tsepong Clinic are provided to patients free of charge, thanks to an agreement between the government of Lesotho and the Global Fund to Fight AIDS, Tuberculosis and Malaria. In 2006 children on ARVs at Tsepong will benefit from a guaranteed pediatric drug supply for the entire year, thanks to generous support from The Clinton Foundation, created by former President Bill Clinton. The Clinton Foundation was instrumental in negotiating the deal with pharmaceuticals companies to allow for the sale of generic antiretroviral drugs, which in turn allowed third-world countries access to life-saving treatment. The Clinton Foundation has a particular focus on ensuring that children get access to antiretroviral drugs and has been supportive of pediatric drug supply in Lesotho.

When the OHAfrica team arrived at Tsepong in December 2004, there were only nine patients enrolled on ARVs and 116 patients registered at the clinic. By the end of December 2005, the Tsepong Clinic had enrolled 1,151 patients on ARV treatment and 3,649 HIV-positive clients were registered at the clinic.

The impact of the OHAfrica project and the work of the Tsepong Clinic is seen in the lives of individuals, in the atmosphere of the community, and in the growing support for programs assisting people living with HIV/AIDS in the region. Patients at Tsepong have a new sense of hope and optimism for their future. Since life-saving treatment became more readily available, more people are willing to be tested for HIV, and steps are being taken to help break the stigma and fear surrounding HIV/AIDS within the surrounding community and throughout Lesotho.

The primary goal of OHAfrica is to help Lesotho build a locally sustainable HIV/AIDS treatment program. This is a big challenge in a country where the healthcare system is overburdened and there is a shortage of medical professionals. In recent months, the OHAfrica team has been working with community-based primary care clinics in outlying areas to start the process of rolling out ARV treatment at the local level.

The first year of the OHAfrica project has been marked by many challenges, and ultimately many rewards. OHAfrica has brought together healthcare stakeholders from Ontario and Lesotho to address a health issue of global urgency.

The OHA staff marvels at the impact OHAfrica has made in such a short time. “We took a leap of faith, and we are all proud and grateful that our commitment has been met, through the significant efforts of so many people,” says Hilary Short, OHA president and CEO. TH

Homer is the manager for OHAfrica, The Change Foundation & the Ontario Hospital Association.

OHA is a voluntary organization representing approximately 157 public hospital corporations across 225 sites in Ontario. Founded in 1924 as an independent, non-profit organization, the OHA is the voice of Ontario’s hospitals. For more information about OHAfrica and how you can get involved, visit www.ohafrica.ca or call (416) 205-1463

Editors’ note: During 2006 we will publish coverage of hospital practices in other countries. This and the article on Iraq (p. 28) are the third and fourth articles in that effort.

At the Ontario Hospital Association’s (OHA) CEO Forum in September 2003, Stephen Lewis, the United Nations Secretary General’s Special Envoy for HIV/AIDS in Africa, challenged Ontario’s hospital leaders to take a leadership role in the fight to treat and prevent the spread of HIV/AIDS in sub-Saharan Africa. Lewis’ compelling words evoked an outpouring of interest on the part of Ontario’s healthcare and hospital community, culminating in the launch of the OHAfrica Project in 2004 by the OHA and its affiliated health research foundation, The Change Foundation.

OHAfrica supports a small team of Ontario healthcare professionals working at the first public HIV/AIDS treatment center in the southern African country of Lesotho. The Tsepong “Place of Hope” Clinic is located in the town of Leribe. The Canadian team includes two physicians, one nurse practitioner, one registered nurse, one pharmacist, and one program administrator—all working alongside a small number of local staff.

The landlocked country of Lesotho was chosen at Lewis’ recommendation. The southern African Kingdom of Lesotho was selected as the focus of the OHAfrica project. Close to 30% of all Basotho people between ages 15 and 49 are infected with HIV, and Lesotho has the fourth-highest HIV prevalence rate in the world. More than 100,000 children have been orphaned by HIV/AIDS, and approximately 29,000 people in Lesotho die of AIDS every year.

Since OHAfrica was launched on World AIDS Day in December 2004 the project has accomplished a great deal. The Tsepong Clinic has become the largest antiretroviral (ARV) treatment center in the country, and the clinic enrolls more than half of all new patients put on ARVs in Lesotho each month.

Until recently, antiretroviral drugs were beyond the means of most people in Africa, costing between $12,000 and $15,000 per year. With newly available generic drugs, the cost to provide one person in Lesotho with ARV treatment for one year is now approximately $140—less than .40 cents per day.

The ARV drugs available at the Tsepong Clinic are provided to patients free of charge, thanks to an agreement between the government of Lesotho and the Global Fund to Fight AIDS, Tuberculosis and Malaria. In 2006 children on ARVs at Tsepong will benefit from a guaranteed pediatric drug supply for the entire year, thanks to generous support from The Clinton Foundation, created by former President Bill Clinton. The Clinton Foundation was instrumental in negotiating the deal with pharmaceuticals companies to allow for the sale of generic antiretroviral drugs, which in turn allowed third-world countries access to life-saving treatment. The Clinton Foundation has a particular focus on ensuring that children get access to antiretroviral drugs and has been supportive of pediatric drug supply in Lesotho.

When the OHAfrica team arrived at Tsepong in December 2004, there were only nine patients enrolled on ARVs and 116 patients registered at the clinic. By the end of December 2005, the Tsepong Clinic had enrolled 1,151 patients on ARV treatment and 3,649 HIV-positive clients were registered at the clinic.

The impact of the OHAfrica project and the work of the Tsepong Clinic is seen in the lives of individuals, in the atmosphere of the community, and in the growing support for programs assisting people living with HIV/AIDS in the region. Patients at Tsepong have a new sense of hope and optimism for their future. Since life-saving treatment became more readily available, more people are willing to be tested for HIV, and steps are being taken to help break the stigma and fear surrounding HIV/AIDS within the surrounding community and throughout Lesotho.

The primary goal of OHAfrica is to help Lesotho build a locally sustainable HIV/AIDS treatment program. This is a big challenge in a country where the healthcare system is overburdened and there is a shortage of medical professionals. In recent months, the OHAfrica team has been working with community-based primary care clinics in outlying areas to start the process of rolling out ARV treatment at the local level.

The first year of the OHAfrica project has been marked by many challenges, and ultimately many rewards. OHAfrica has brought together healthcare stakeholders from Ontario and Lesotho to address a health issue of global urgency.

The OHA staff marvels at the impact OHAfrica has made in such a short time. “We took a leap of faith, and we are all proud and grateful that our commitment has been met, through the significant efforts of so many people,” says Hilary Short, OHA president and CEO. TH

Homer is the manager for OHAfrica, The Change Foundation & the Ontario Hospital Association.

OHA is a voluntary organization representing approximately 157 public hospital corporations across 225 sites in Ontario. Founded in 1924 as an independent, non-profit organization, the OHA is the voice of Ontario’s hospitals. For more information about OHAfrica and how you can get involved, visit www.ohafrica.ca or call (416) 205-1463

Editors’ note: During 2006 we will publish coverage of hospital practices in other countries. This and the article on Iraq (p. 28) are the third and fourth articles in that effort.

At the Ontario Hospital Association’s (OHA) CEO Forum in September 2003, Stephen Lewis, the United Nations Secretary General’s Special Envoy for HIV/AIDS in Africa, challenged Ontario’s hospital leaders to take a leadership role in the fight to treat and prevent the spread of HIV/AIDS in sub-Saharan Africa. Lewis’ compelling words evoked an outpouring of interest on the part of Ontario’s healthcare and hospital community, culminating in the launch of the OHAfrica Project in 2004 by the OHA and its affiliated health research foundation, The Change Foundation.

OHAfrica supports a small team of Ontario healthcare professionals working at the first public HIV/AIDS treatment center in the southern African country of Lesotho. The Tsepong “Place of Hope” Clinic is located in the town of Leribe. The Canadian team includes two physicians, one nurse practitioner, one registered nurse, one pharmacist, and one program administrator—all working alongside a small number of local staff.

The landlocked country of Lesotho was chosen at Lewis’ recommendation. The southern African Kingdom of Lesotho was selected as the focus of the OHAfrica project. Close to 30% of all Basotho people between ages 15 and 49 are infected with HIV, and Lesotho has the fourth-highest HIV prevalence rate in the world. More than 100,000 children have been orphaned by HIV/AIDS, and approximately 29,000 people in Lesotho die of AIDS every year.

Since OHAfrica was launched on World AIDS Day in December 2004 the project has accomplished a great deal. The Tsepong Clinic has become the largest antiretroviral (ARV) treatment center in the country, and the clinic enrolls more than half of all new patients put on ARVs in Lesotho each month.

Until recently, antiretroviral drugs were beyond the means of most people in Africa, costing between $12,000 and $15,000 per year. With newly available generic drugs, the cost to provide one person in Lesotho with ARV treatment for one year is now approximately $140—less than .40 cents per day.

The ARV drugs available at the Tsepong Clinic are provided to patients free of charge, thanks to an agreement between the government of Lesotho and the Global Fund to Fight AIDS, Tuberculosis and Malaria. In 2006 children on ARVs at Tsepong will benefit from a guaranteed pediatric drug supply for the entire year, thanks to generous support from The Clinton Foundation, created by former President Bill Clinton. The Clinton Foundation was instrumental in negotiating the deal with pharmaceuticals companies to allow for the sale of generic antiretroviral drugs, which in turn allowed third-world countries access to life-saving treatment. The Clinton Foundation has a particular focus on ensuring that children get access to antiretroviral drugs and has been supportive of pediatric drug supply in Lesotho.

When the OHAfrica team arrived at Tsepong in December 2004, there were only nine patients enrolled on ARVs and 116 patients registered at the clinic. By the end of December 2005, the Tsepong Clinic had enrolled 1,151 patients on ARV treatment and 3,649 HIV-positive clients were registered at the clinic.

The impact of the OHAfrica project and the work of the Tsepong Clinic is seen in the lives of individuals, in the atmosphere of the community, and in the growing support for programs assisting people living with HIV/AIDS in the region. Patients at Tsepong have a new sense of hope and optimism for their future. Since life-saving treatment became more readily available, more people are willing to be tested for HIV, and steps are being taken to help break the stigma and fear surrounding HIV/AIDS within the surrounding community and throughout Lesotho.

The primary goal of OHAfrica is to help Lesotho build a locally sustainable HIV/AIDS treatment program. This is a big challenge in a country where the healthcare system is overburdened and there is a shortage of medical professionals. In recent months, the OHAfrica team has been working with community-based primary care clinics in outlying areas to start the process of rolling out ARV treatment at the local level.

The first year of the OHAfrica project has been marked by many challenges, and ultimately many rewards. OHAfrica has brought together healthcare stakeholders from Ontario and Lesotho to address a health issue of global urgency.

The OHA staff marvels at the impact OHAfrica has made in such a short time. “We took a leap of faith, and we are all proud and grateful that our commitment has been met, through the significant efforts of so many people,” says Hilary Short, OHA president and CEO. TH

Homer is the manager for OHAfrica, The Change Foundation & the Ontario Hospital Association.

OHA is a voluntary organization representing approximately 157 public hospital corporations across 225 sites in Ontario. Founded in 1924 as an independent, non-profit organization, the OHA is the voice of Ontario’s hospitals. For more information about OHAfrica and how you can get involved, visit www.ohafrica.ca or call (416) 205-1463

It’s extremely hard being in a room with a family that is angry, confrontational, and hostile,” says clinical social worker Jane B. Hawgood, MSW, who often works with the hospitalist group on the General Medicine Service at the University of California at San Francisco Medical Center. “When you read about these cases in a textbook, it seems so clean and neat.”

Hospitalists have all encountered them: family members who, because of their behavior toward providers, come to be labeled as “difficult.” What are the best ways to deal with patients’ family members who are unresponsive, overbearing, or outright hostile to physicians and the care team? And how do you proceed to a treatment plan that is best for the patient?

The first step, believes Thomas Baudendistel, MD, FACP, associate program director of the Internal Medicine Residency Program at Sutter Health’s California Pacific Medical Center in San Francisco, and chair of SHM’s Ethics Committee, is to avoid using the term “difficult.”

“I think ‘difficult’ is a loaded term and kind of pejorative,” says Dr. Baudendistel. “When their loved ones are in the hospital, families are vulnerable. They don’t really know what to expect. I don’t know that I wouldn’t want my grandmother, or mother described as a ‘difficult patient,’ or a family member described as ‘difficult.’ Rather than saying, ‘this is a difficult family member,’ I would rather phrase it, ‘This is someone who has a lot of worries.’ ”

Hawgood employs a similar approach. “I like to define the situation as ‘a family member who is having difficulty dealing with the patient’s illness,’” she says. “If I hear, during rounds, that this family is difficult, I immediately begin asking myself, ‘Why are they having difficulty? Is this an interpersonal issue? Does this family member have a psychiatric history? Is there a history of a past problem with the medical system? Is it a financial issue?’ I really try not to presume things. I always try and keep an open mind about what a patient’s and family’s goals are, and what I can do to help. You need to clearly understand your goals and have good support from your team to redirect the energy.”

“Unrealistic expectations” might describe some of the encounters for Adrienne Bennett, MD, director for the Division of Hospital Medicine and associate clinical professor of medicine at Ohio State University. In her former post as founder and director of hospitalist services at Newton Wellesley, a community teaching hospital in the western suburbs of Boston, she and colleagues dealt with a relatively affluent patient population. Some of the patients and families, she says, “can sometimes be somewhat demanding and difficult if they feel they aren’t getting what they’re entitled to. In that sense, they can become ‘the angry daughter,’ as my colleague used to say.”

Building Trust

Because they do not have an ongoing history with patients, hospitalists may often be starting at a disadvantage in forming a new relationship. Dr. Baudendistel believes hospitalists can quickly learn the skill of reassuring patients and their families. One way to do that, he says, is to “link with the primary care physician.” He often calls the primary care physician and tells the family of his conversations with the family doctor, thus establishing a level of comfort for them. He makes it clear to the family that he is available to them, giving them phone and pager numbers so they can easily reach him.

Dr. Baudendistel also tries to accommodate family members’ schedules, setting up visits when working family members are able to come to the hospital or making sure to have daily telephone contact if it is not possible to synchronize in-person visits with them.

Most families, he has found, are then willing to listen and work with him. As familiarity with hospitalists increases, family concerns about a “stranger” caring for their loved one slowly diminish. “Patients and families generally accept the idea of seeing a new doctor in the hospital a little bit more easily each year that goes by,” he notes.

Another technique used at California Pacific Medical Center, Dr. Baudendistel adds, is to pair a hospitalist with the same patient if he or she is readmitted. “We really believe in the continuity of the relationship, so we try to preserve that as much as possible,” he says, “because the big obstacle for hospitalists is always handoffs.”

On the Same Page

Intrinsic to forming a relationship with the patient and family is to discuss their goals of care, says Hawgood. Shana Weber, DO, FAAP, a pediatric hospitalist at Alaska Native Medical Center in Anchorage, agrees.

“You need to be on the same page,” she says. “Without knowing what the parents are hoping to get from their child’s stay before discharge, you really cannot help them.”

For instance, says Dr. Weber, some parents may be surprised to learn that their child is going to be sent home with a feeding tube or other nursing care needs.

“It is important to find out what their agenda is and what yours is. Parents’ expectations can be very different from ours,” she explains. “Letting parents know you’re listening—whether or not you agree with what they’re saying—is half the battle. You need to verify their feelings, let them know you’re listening to them, and that you understand their concerns.”

Use Team Resources

Accessing the expertise of other providers may be necessary to complete discharge plans for complicated cases. Dr. Baudendistel recalls a 30-year-old woman with a progressive neurological condition who had previously been living in the community. Her condition had deteriorated to the extent that she would no longer be able to eat safely, and, thus, she would not be able to return home. The team brought in a speech therapist, physical therapist, social worker, and discharge planner to meet with the family and present options.

Hospitalists interviewed for this article agreed that clinical social workers bring a much-needed perspective to dealing with families. One recent case at UCSF Medical Center involved a woman in her late 50s whose cancer, after multiple treatments and treatment complications, had come back very aggressively. One of her daughters, a young woman in her 20s, “had developed a very deep religious faith that she could cure her mother through prayers and faith,” recalls Hawgood. “As her mother deteriorated, the daughter became more angry and hostile to the hospitalists.”

Hawgood approached the daughter and asked if she would sit down and talk with her, and tell her what had gone wrong in the past, and “how we could improve things in the future.” As she listened to the daughter, she realized how much the daughter loved her mother and how desperately frightened she was.

“If I could help you in one way, what would that be?” Hawgood asked the daughter.

After a silence, the daughter replied, “We need a refrigerator.”

It turned out that the family was financially unable to replace a broken refrigerator. To take her mother home, the daughter needed a way to refrigerate enteral feeding supplies. And Hawgood was able to secure a refrigerator for the family, and says that the incident underscored for her the importance of keeping an open mind.

Later, when the mother was dying, Hawgood was again asked by the team to provide support for the daughter so that hospitalists could care for their patient. “She was so angry, and it was directed at the hospitalists,” recalls Hawgood. “It was just her absolute inability to accept that her mother, who was the center in her life, was going to die. You have to give people credit and respect. You have to understand where they’re coming from and what’s going to work for them.”

Training Adequate?

According to a 2003-2004 survey conducted by the American Association of Medical Colleges, 124 out of 125 medical schools included communication skills as required courses for their medical students.1 However, Dr. Baudendistel points out that there are currently no national standards for proficiency in communications skills and that the field is in relative infancy at this time. Inclusion of interpersonal and communication skills as one of the Accreditation Council for Graduate Medical Education’s (ACGME) core competencies will help focus more attention on how to teach communication skills, he believes.2

“Communication is now one of the six core competencies,” he says. “It’s no longer secondary to being a smart doctor: It’s equally important in the view of the ACGME. So I think that will help.”

Beyond standardization of communication skills curricula, it is also necessary, he emphasizes, to verify providers’ proficiency in those skills. In the California Pacific Medical Center’s residency program residents receive 360-degree evaluations. These go beyond the typical evaluations in the past, wherein residents would be evaluated by supervising attending physicians and interns working under them. Now, evaluations of residents are sought from nurses—and from the patients themselves. Obtaining 360-degree feedback from all those who have interacted with the resident functions as a valuable teaching tool.

Experience: the Best Teacher

While most agree that training and required communications courses should be increased, Dr. Bennett points out that some of the hospitalist’s expertise with family communications will simply evolve with time and experience.

“I’ve learned a lot from situations in group meetings with a social worker or a patient ombudsperson, just watching how they manage the situation,” she says. At Newton Wellesley Hospital, social workers and chaplains were sometimes better able to find the right way to phrase something so it came across in a way the family could accept, recalls Dr. Bennett. She raises the a case of a 50-year-old man who came in with cardiac arrest and whom they needed to withdraw from life support. He had been born and raised Catholic, but had converted to Judaism, which was his ex-wife’s religion as well as that of his children. He had an extensive family (he was one of 10 children), who were concerned about his ability to receive Catholic last rites. The chaplain understood the implications for both religions and was able to negotiate a compromise that satisfied both sides and allowed life support to be withdrawn.

Dr. Weber, who completed her residency at DeVos Children’s Hospital in Grand Rapids, Mich., praised the training she received in doctor-patient communications while in medical school. However, once she arrived in Anchorage, she discovered that the cultural norms of Alaska native people required some on-the-job learning.

She once asked an adolescent girl with Crohn’s disease whether she had any belly pain. “She wasn’t answering me, and I thought, ‘Oh great—just another typical teenage girl’” remembers Dr. Weber. “Well, I thought she wasn’t answering me, but she was lifting her eyebrows, which means ‘yes.’ But I didn’t know that.”

Dr. Weber has found nurses and other long-time hospital staff to be very helpful in learning how to communicate with her patient population.

Context and History

Hawgood reminds hospitalists that families often come into hospitals with past histories of things gone wrong.

“The whole healthcare system is so volatile now,” she observes. “People feel rushed, they feel [they are being] rushed out of hospital. They don’t have adequate healthcare insurance; they don’t have adequate care in the community. We send people out with trachs, tube feeds, open wounds, and pain issues. People are dealing with limited money, trying to juggle work, children, and elderly parents. So they have reasons to be angry.”

Families feel frustrated when their loved one is sick, agrees Dr. Baudendistel. “It may be that your role is to just let them vent their frustration.”

Says Hawgood, “I tell the people I train that I have nothing to lose. The patients and their families have everything to lose. So, even if I get off on the wrong foot, I’ll go back and ask, ‘could I start again?’ And usually, people will say, ‘yes.’ It’s up to me to make it work.”

Dr. Weber recalls one family at ANMC with a special needs child who had been in a Seattle hospital, and was readmitted to their facility with kidney stones. He was not getting better and the physicians recommended that the family travel back to Seattle, where a pediatric urologist could remove the stones. The parents were uncomfortable with the recommendation that their son return to Seattle.

“We did need to bring in a mediator, and have several family care conferences with the parents, with social workers and discharge planners, and all involved providers,” says Dr. Weber.

In the course of the conferences, the family revealed that their child’s disabilities were due to a missed diagnosis of meningitis when he was a baby. “They harbored a lot of resentment toward the medical profession in general,” says Dr. Weber. “It was hard to work through that. They couldn’t let it go—and I don’t blame them—and it caused them to always question our motives and our intentions.”

During the care conferences, the team let the family tell their story of the meningitis case again. Just by listening to the family’s history with that event, the team was able to validate the family’s concerns. The parents agreed to take their son to Seattle for the procedure, and later sent a thank you card to the pediatric team at ANMC that had treated him.

Don’t Make Assumptions

Hawgood always cautions physicians to enter the patient’s room with an open mind and to be open to cues and clues about the family’s situation. She praises the UCSF hospitalists’ training of young residents.

“They let them take the lead in patient interviews, then we all discuss how that interview went, and how things could have been done better,” says Hawgood. For instance, she recommends that hospitalists “allow for some silence in the room. You don’t have to fill up every minute with conversation. Look for the non-verbal cues, the things that weren’t said.”

In Dr. Weber’s hospital, pediatric patients come from all over state. It is not unusual for a baby to be in the neonatal intensive care unit for a while before the parents come back to visit. It would be easy to question, she says, whether these people are going to be good parents. “But until you know their social situation, you really have no place saying that,” says Dr. Weber. “You may find that they have six other children at home and cannot be here because they have no other caregivers for their children, and their village is 200 miles away.”

The Best You Can Do

Despite the care team’s best efforts, there will be a few cases, admits Dr. Bennett, where “you just can’t make much headway.” She recalls the case of an elderly man who had had a massive stroke, lived in a nursing home, and had not communicated for years. The man’s daughter was convinced, however, that he communicated with her and was “adamant that everything had to be done. We tried and tried,” explains Dr. Bennett, calling several group meetings and using hospital chaplains as allies, “but she just couldn’t hear it, and couldn’t see it [that her father would not get better]. She was too vested in believing that he did, in fact, communicate with her and that he would get better.”

In such cases the team may have to do the best they can to honor the patient’s and the family member’s value system and help them abide by that.

“There’s one other thing about difficult families and difficult patients: You have such an intense relationship with them that you don’t have with other people,” notes Hawgood. “If you can hang in there, they’re the best relationships you can have. You are so emotionally engaged in trying to make it work. I have chosen to work with hospitalists because of the approach they take. I think it’s the most efficient model you can use in a hospital. We really talk about the goals of care, and what we understand about the patient’s and family’s goals of care. We approach this from the point of view that they deserve care. What can we do to make a difference, so that it works for the patient and the families?” TH

Writer Gretchen Henkel lives in California.

References

• “Number of U.S. Medical Schools Teaching Selected Topics 2003-2004.” Compiled by the American Association of Medical Colleges Institutional Profile System. Available online at: http://services.aamc.org/currdir/section2/03-04hottopics.pdf. Last accessed January 26, 2006.
• General Competencies; ACGME Outcome Project. September, 1999. Available online at: www.acgme.org/outcome/comp/compMin.asp. Last accessed January 27, 2006.

It’s extremely hard being in a room with a family that is angry, confrontational, and hostile,” says clinical social worker Jane B. Hawgood, MSW, who often works with the hospitalist group on the General Medicine Service at the University of California at San Francisco Medical Center. “When you read about these cases in a textbook, it seems so clean and neat.”

Hospitalists have all encountered them: family members who, because of their behavior toward providers, come to be labeled as “difficult.” What are the best ways to deal with patients’ family members who are unresponsive, overbearing, or outright hostile to physicians and the care team? And how do you proceed to a treatment plan that is best for the patient?

The first step, believes Thomas Baudendistel, MD, FACP, associate program director of the Internal Medicine Residency Program at Sutter Health’s California Pacific Medical Center in San Francisco, and chair of SHM’s Ethics Committee, is to avoid using the term “difficult.”

“I think ‘difficult’ is a loaded term and kind of pejorative,” says Dr. Baudendistel. “When their loved ones are in the hospital, families are vulnerable. They don’t really know what to expect. I don’t know that I wouldn’t want my grandmother, or mother described as a ‘difficult patient,’ or a family member described as ‘difficult.’ Rather than saying, ‘this is a difficult family member,’ I would rather phrase it, ‘This is someone who has a lot of worries.’ ”

Hawgood employs a similar approach. “I like to define the situation as ‘a family member who is having difficulty dealing with the patient’s illness,’” she says. “If I hear, during rounds, that this family is difficult, I immediately begin asking myself, ‘Why are they having difficulty? Is this an interpersonal issue? Does this family member have a psychiatric history? Is there a history of a past problem with the medical system? Is it a financial issue?’ I really try not to presume things. I always try and keep an open mind about what a patient’s and family’s goals are, and what I can do to help. You need to clearly understand your goals and have good support from your team to redirect the energy.”

“Unrealistic expectations” might describe some of the encounters for Adrienne Bennett, MD, director for the Division of Hospital Medicine and associate clinical professor of medicine at Ohio State University. In her former post as founder and director of hospitalist services at Newton Wellesley, a community teaching hospital in the western suburbs of Boston, she and colleagues dealt with a relatively affluent patient population. Some of the patients and families, she says, “can sometimes be somewhat demanding and difficult if they feel they aren’t getting what they’re entitled to. In that sense, they can become ‘the angry daughter,’ as my colleague used to say.”

Building Trust

Because they do not have an ongoing history with patients, hospitalists may often be starting at a disadvantage in forming a new relationship. Dr. Baudendistel believes hospitalists can quickly learn the skill of reassuring patients and their families. One way to do that, he says, is to “link with the primary care physician.” He often calls the primary care physician and tells the family of his conversations with the family doctor, thus establishing a level of comfort for them. He makes it clear to the family that he is available to them, giving them phone and pager numbers so they can easily reach him.

Dr. Baudendistel also tries to accommodate family members’ schedules, setting up visits when working family members are able to come to the hospital or making sure to have daily telephone contact if it is not possible to synchronize in-person visits with them.

Most families, he has found, are then willing to listen and work with him. As familiarity with hospitalists increases, family concerns about a “stranger” caring for their loved one slowly diminish. “Patients and families generally accept the idea of seeing a new doctor in the hospital a little bit more easily each year that goes by,” he notes.

Another technique used at California Pacific Medical Center, Dr. Baudendistel adds, is to pair a hospitalist with the same patient if he or she is readmitted. “We really believe in the continuity of the relationship, so we try to preserve that as much as possible,” he says, “because the big obstacle for hospitalists is always handoffs.”

On the Same Page

Intrinsic to forming a relationship with the patient and family is to discuss their goals of care, says Hawgood. Shana Weber, DO, FAAP, a pediatric hospitalist at Alaska Native Medical Center in Anchorage, agrees.

“You need to be on the same page,” she says. “Without knowing what the parents are hoping to get from their child’s stay before discharge, you really cannot help them.”

For instance, says Dr. Weber, some parents may be surprised to learn that their child is going to be sent home with a feeding tube or other nursing care needs.

“It is important to find out what their agenda is and what yours is. Parents’ expectations can be very different from ours,” she explains. “Letting parents know you’re listening—whether or not you agree with what they’re saying—is half the battle. You need to verify their feelings, let them know you’re listening to them, and that you understand their concerns.”

Use Team Resources

Accessing the expertise of other providers may be necessary to complete discharge plans for complicated cases. Dr. Baudendistel recalls a 30-year-old woman with a progressive neurological condition who had previously been living in the community. Her condition had deteriorated to the extent that she would no longer be able to eat safely, and, thus, she would not be able to return home. The team brought in a speech therapist, physical therapist, social worker, and discharge planner to meet with the family and present options.

Hospitalists interviewed for this article agreed that clinical social workers bring a much-needed perspective to dealing with families. One recent case at UCSF Medical Center involved a woman in her late 50s whose cancer, after multiple treatments and treatment complications, had come back very aggressively. One of her daughters, a young woman in her 20s, “had developed a very deep religious faith that she could cure her mother through prayers and faith,” recalls Hawgood. “As her mother deteriorated, the daughter became more angry and hostile to the hospitalists.”

Hawgood approached the daughter and asked if she would sit down and talk with her, and tell her what had gone wrong in the past, and “how we could improve things in the future.” As she listened to the daughter, she realized how much the daughter loved her mother and how desperately frightened she was.

“If I could help you in one way, what would that be?” Hawgood asked the daughter.

After a silence, the daughter replied, “We need a refrigerator.”

It turned out that the family was financially unable to replace a broken refrigerator. To take her mother home, the daughter needed a way to refrigerate enteral feeding supplies. And Hawgood was able to secure a refrigerator for the family, and says that the incident underscored for her the importance of keeping an open mind.

Later, when the mother was dying, Hawgood was again asked by the team to provide support for the daughter so that hospitalists could care for their patient. “She was so angry, and it was directed at the hospitalists,” recalls Hawgood. “It was just her absolute inability to accept that her mother, who was the center in her life, was going to die. You have to give people credit and respect. You have to understand where they’re coming from and what’s going to work for them.”

Training Adequate?

According to a 2003-2004 survey conducted by the American Association of Medical Colleges, 124 out of 125 medical schools included communication skills as required courses for their medical students.1 However, Dr. Baudendistel points out that there are currently no national standards for proficiency in communications skills and that the field is in relative infancy at this time. Inclusion of interpersonal and communication skills as one of the Accreditation Council for Graduate Medical Education’s (ACGME) core competencies will help focus more attention on how to teach communication skills, he believes.2

“Communication is now one of the six core competencies,” he says. “It’s no longer secondary to being a smart doctor: It’s equally important in the view of the ACGME. So I think that will help.”

Beyond standardization of communication skills curricula, it is also necessary, he emphasizes, to verify providers’ proficiency in those skills. In the California Pacific Medical Center’s residency program residents receive 360-degree evaluations. These go beyond the typical evaluations in the past, wherein residents would be evaluated by supervising attending physicians and interns working under them. Now, evaluations of residents are sought from nurses—and from the patients themselves. Obtaining 360-degree feedback from all those who have interacted with the resident functions as a valuable teaching tool.

Experience: the Best Teacher

While most agree that training and required communications courses should be increased, Dr. Bennett points out that some of the hospitalist’s expertise with family communications will simply evolve with time and experience.

“I’ve learned a lot from situations in group meetings with a social worker or a patient ombudsperson, just watching how they manage the situation,” she says. At Newton Wellesley Hospital, social workers and chaplains were sometimes better able to find the right way to phrase something so it came across in a way the family could accept, recalls Dr. Bennett. She raises the a case of a 50-year-old man who came in with cardiac arrest and whom they needed to withdraw from life support. He had been born and raised Catholic, but had converted to Judaism, which was his ex-wife’s religion as well as that of his children. He had an extensive family (he was one of 10 children), who were concerned about his ability to receive Catholic last rites. The chaplain understood the implications for both religions and was able to negotiate a compromise that satisfied both sides and allowed life support to be withdrawn.

Dr. Weber, who completed her residency at DeVos Children’s Hospital in Grand Rapids, Mich., praised the training she received in doctor-patient communications while in medical school. However, once she arrived in Anchorage, she discovered that the cultural norms of Alaska native people required some on-the-job learning.

She once asked an adolescent girl with Crohn’s disease whether she had any belly pain. “She wasn’t answering me, and I thought, ‘Oh great—just another typical teenage girl’” remembers Dr. Weber. “Well, I thought she wasn’t answering me, but she was lifting her eyebrows, which means ‘yes.’ But I didn’t know that.”

Dr. Weber has found nurses and other long-time hospital staff to be very helpful in learning how to communicate with her patient population.

Context and History

Hawgood reminds hospitalists that families often come into hospitals with past histories of things gone wrong.

“The whole healthcare system is so volatile now,” she observes. “People feel rushed, they feel [they are being] rushed out of hospital. They don’t have adequate healthcare insurance; they don’t have adequate care in the community. We send people out with trachs, tube feeds, open wounds, and pain issues. People are dealing with limited money, trying to juggle work, children, and elderly parents. So they have reasons to be angry.”

Families feel frustrated when their loved one is sick, agrees Dr. Baudendistel. “It may be that your role is to just let them vent their frustration.”

Says Hawgood, “I tell the people I train that I have nothing to lose. The patients and their families have everything to lose. So, even if I get off on the wrong foot, I’ll go back and ask, ‘could I start again?’ And usually, people will say, ‘yes.’ It’s up to me to make it work.”

Dr. Weber recalls one family at ANMC with a special needs child who had been in a Seattle hospital, and was readmitted to their facility with kidney stones. He was not getting better and the physicians recommended that the family travel back to Seattle, where a pediatric urologist could remove the stones. The parents were uncomfortable with the recommendation that their son return to Seattle.

“We did need to bring in a mediator, and have several family care conferences with the parents, with social workers and discharge planners, and all involved providers,” says Dr. Weber.

In the course of the conferences, the family revealed that their child’s disabilities were due to a missed diagnosis of meningitis when he was a baby. “They harbored a lot of resentment toward the medical profession in general,” says Dr. Weber. “It was hard to work through that. They couldn’t let it go—and I don’t blame them—and it caused them to always question our motives and our intentions.”

During the care conferences, the team let the family tell their story of the meningitis case again. Just by listening to the family’s history with that event, the team was able to validate the family’s concerns. The parents agreed to take their son to Seattle for the procedure, and later sent a thank you card to the pediatric team at ANMC that had treated him.

Don’t Make Assumptions

Hawgood always cautions physicians to enter the patient’s room with an open mind and to be open to cues and clues about the family’s situation. She praises the UCSF hospitalists’ training of young residents.

“They let them take the lead in patient interviews, then we all discuss how that interview went, and how things could have been done better,” says Hawgood. For instance, she recommends that hospitalists “allow for some silence in the room. You don’t have to fill up every minute with conversation. Look for the non-verbal cues, the things that weren’t said.”

In Dr. Weber’s hospital, pediatric patients come from all over state. It is not unusual for a baby to be in the neonatal intensive care unit for a while before the parents come back to visit. It would be easy to question, she says, whether these people are going to be good parents. “But until you know their social situation, you really have no place saying that,” says Dr. Weber. “You may find that they have six other children at home and cannot be here because they have no other caregivers for their children, and their village is 200 miles away.”

The Best You Can Do

Despite the care team’s best efforts, there will be a few cases, admits Dr. Bennett, where “you just can’t make much headway.” She recalls the case of an elderly man who had had a massive stroke, lived in a nursing home, and had not communicated for years. The man’s daughter was convinced, however, that he communicated with her and was “adamant that everything had to be done. We tried and tried,” explains Dr. Bennett, calling several group meetings and using hospital chaplains as allies, “but she just couldn’t hear it, and couldn’t see it [that her father would not get better]. She was too vested in believing that he did, in fact, communicate with her and that he would get better.”

In such cases the team may have to do the best they can to honor the patient’s and the family member’s value system and help them abide by that.

“There’s one other thing about difficult families and difficult patients: You have such an intense relationship with them that you don’t have with other people,” notes Hawgood. “If you can hang in there, they’re the best relationships you can have. You are so emotionally engaged in trying to make it work. I have chosen to work with hospitalists because of the approach they take. I think it’s the most efficient model you can use in a hospital. We really talk about the goals of care, and what we understand about the patient’s and family’s goals of care. We approach this from the point of view that they deserve care. What can we do to make a difference, so that it works for the patient and the families?” TH

Writer Gretchen Henkel lives in California.

References

• “Number of U.S. Medical Schools Teaching Selected Topics 2003-2004.” Compiled by the American Association of Medical Colleges Institutional Profile System. Available online at: http://services.aamc.org/currdir/section2/03-04hottopics.pdf. Last accessed January 26, 2006.
• General Competencies; ACGME Outcome Project. September, 1999. Available online at: www.acgme.org/outcome/comp/compMin.asp. Last accessed January 27, 2006.

It’s extremely hard being in a room with a family that is angry, confrontational, and hostile,” says clinical social worker Jane B. Hawgood, MSW, who often works with the hospitalist group on the General Medicine Service at the University of California at San Francisco Medical Center. “When you read about these cases in a textbook, it seems so clean and neat.”

Hospitalists have all encountered them: family members who, because of their behavior toward providers, come to be labeled as “difficult.” What are the best ways to deal with patients’ family members who are unresponsive, overbearing, or outright hostile to physicians and the care team? And how do you proceed to a treatment plan that is best for the patient?

The first step, believes Thomas Baudendistel, MD, FACP, associate program director of the Internal Medicine Residency Program at Sutter Health’s California Pacific Medical Center in San Francisco, and chair of SHM’s Ethics Committee, is to avoid using the term “difficult.”

“I think ‘difficult’ is a loaded term and kind of pejorative,” says Dr. Baudendistel. “When their loved ones are in the hospital, families are vulnerable. They don’t really know what to expect. I don’t know that I wouldn’t want my grandmother, or mother described as a ‘difficult patient,’ or a family member described as ‘difficult.’ Rather than saying, ‘this is a difficult family member,’ I would rather phrase it, ‘This is someone who has a lot of worries.’ ”

Hawgood employs a similar approach. “I like to define the situation as ‘a family member who is having difficulty dealing with the patient’s illness,’” she says. “If I hear, during rounds, that this family is difficult, I immediately begin asking myself, ‘Why are they having difficulty? Is this an interpersonal issue? Does this family member have a psychiatric history? Is there a history of a past problem with the medical system? Is it a financial issue?’ I really try not to presume things. I always try and keep an open mind about what a patient’s and family’s goals are, and what I can do to help. You need to clearly understand your goals and have good support from your team to redirect the energy.”

“Unrealistic expectations” might describe some of the encounters for Adrienne Bennett, MD, director for the Division of Hospital Medicine and associate clinical professor of medicine at Ohio State University. In her former post as founder and director of hospitalist services at Newton Wellesley, a community teaching hospital in the western suburbs of Boston, she and colleagues dealt with a relatively affluent patient population. Some of the patients and families, she says, “can sometimes be somewhat demanding and difficult if they feel they aren’t getting what they’re entitled to. In that sense, they can become ‘the angry daughter,’ as my colleague used to say.”

Building Trust

Because they do not have an ongoing history with patients, hospitalists may often be starting at a disadvantage in forming a new relationship. Dr. Baudendistel believes hospitalists can quickly learn the skill of reassuring patients and their families. One way to do that, he says, is to “link with the primary care physician.” He often calls the primary care physician and tells the family of his conversations with the family doctor, thus establishing a level of comfort for them. He makes it clear to the family that he is available to them, giving them phone and pager numbers so they can easily reach him.

Dr. Baudendistel also tries to accommodate family members’ schedules, setting up visits when working family members are able to come to the hospital or making sure to have daily telephone contact if it is not possible to synchronize in-person visits with them.

Most families, he has found, are then willing to listen and work with him. As familiarity with hospitalists increases, family concerns about a “stranger” caring for their loved one slowly diminish. “Patients and families generally accept the idea of seeing a new doctor in the hospital a little bit more easily each year that goes by,” he notes.

Another technique used at California Pacific Medical Center, Dr. Baudendistel adds, is to pair a hospitalist with the same patient if he or she is readmitted. “We really believe in the continuity of the relationship, so we try to preserve that as much as possible,” he says, “because the big obstacle for hospitalists is always handoffs.”

On the Same Page

Intrinsic to forming a relationship with the patient and family is to discuss their goals of care, says Hawgood. Shana Weber, DO, FAAP, a pediatric hospitalist at Alaska Native Medical Center in Anchorage, agrees.

“You need to be on the same page,” she says. “Without knowing what the parents are hoping to get from their child’s stay before discharge, you really cannot help them.”

For instance, says Dr. Weber, some parents may be surprised to learn that their child is going to be sent home with a feeding tube or other nursing care needs.

“It is important to find out what their agenda is and what yours is. Parents’ expectations can be very different from ours,” she explains. “Letting parents know you’re listening—whether or not you agree with what they’re saying—is half the battle. You need to verify their feelings, let them know you’re listening to them, and that you understand their concerns.”

Use Team Resources

Accessing the expertise of other providers may be necessary to complete discharge plans for complicated cases. Dr. Baudendistel recalls a 30-year-old woman with a progressive neurological condition who had previously been living in the community. Her condition had deteriorated to the extent that she would no longer be able to eat safely, and, thus, she would not be able to return home. The team brought in a speech therapist, physical therapist, social worker, and discharge planner to meet with the family and present options.

Hospitalists interviewed for this article agreed that clinical social workers bring a much-needed perspective to dealing with families. One recent case at UCSF Medical Center involved a woman in her late 50s whose cancer, after multiple treatments and treatment complications, had come back very aggressively. One of her daughters, a young woman in her 20s, “had developed a very deep religious faith that she could cure her mother through prayers and faith,” recalls Hawgood. “As her mother deteriorated, the daughter became more angry and hostile to the hospitalists.”

Hawgood approached the daughter and asked if she would sit down and talk with her, and tell her what had gone wrong in the past, and “how we could improve things in the future.” As she listened to the daughter, she realized how much the daughter loved her mother and how desperately frightened she was.

“If I could help you in one way, what would that be?” Hawgood asked the daughter.

After a silence, the daughter replied, “We need a refrigerator.”

It turned out that the family was financially unable to replace a broken refrigerator. To take her mother home, the daughter needed a way to refrigerate enteral feeding supplies. And Hawgood was able to secure a refrigerator for the family, and says that the incident underscored for her the importance of keeping an open mind.

Later, when the mother was dying, Hawgood was again asked by the team to provide support for the daughter so that hospitalists could care for their patient. “She was so angry, and it was directed at the hospitalists,” recalls Hawgood. “It was just her absolute inability to accept that her mother, who was the center in her life, was going to die. You have to give people credit and respect. You have to understand where they’re coming from and what’s going to work for them.”

Training Adequate?

According to a 2003-2004 survey conducted by the American Association of Medical Colleges, 124 out of 125 medical schools included communication skills as required courses for their medical students.1 However, Dr. Baudendistel points out that there are currently no national standards for proficiency in communications skills and that the field is in relative infancy at this time. Inclusion of interpersonal and communication skills as one of the Accreditation Council for Graduate Medical Education’s (ACGME) core competencies will help focus more attention on how to teach communication skills, he believes.2

“Communication is now one of the six core competencies,” he says. “It’s no longer secondary to being a smart doctor: It’s equally important in the view of the ACGME. So I think that will help.”

Beyond standardization of communication skills curricula, it is also necessary, he emphasizes, to verify providers’ proficiency in those skills. In the California Pacific Medical Center’s residency program residents receive 360-degree evaluations. These go beyond the typical evaluations in the past, wherein residents would be evaluated by supervising attending physicians and interns working under them. Now, evaluations of residents are sought from nurses—and from the patients themselves. Obtaining 360-degree feedback from all those who have interacted with the resident functions as a valuable teaching tool.

Experience: the Best Teacher

While most agree that training and required communications courses should be increased, Dr. Bennett points out that some of the hospitalist’s expertise with family communications will simply evolve with time and experience.

“I’ve learned a lot from situations in group meetings with a social worker or a patient ombudsperson, just watching how they manage the situation,” she says. At Newton Wellesley Hospital, social workers and chaplains were sometimes better able to find the right way to phrase something so it came across in a way the family could accept, recalls Dr. Bennett. She raises the a case of a 50-year-old man who came in with cardiac arrest and whom they needed to withdraw from life support. He had been born and raised Catholic, but had converted to Judaism, which was his ex-wife’s religion as well as that of his children. He had an extensive family (he was one of 10 children), who were concerned about his ability to receive Catholic last rites. The chaplain understood the implications for both religions and was able to negotiate a compromise that satisfied both sides and allowed life support to be withdrawn.

Dr. Weber, who completed her residency at DeVos Children’s Hospital in Grand Rapids, Mich., praised the training she received in doctor-patient communications while in medical school. However, once she arrived in Anchorage, she discovered that the cultural norms of Alaska native people required some on-the-job learning.

She once asked an adolescent girl with Crohn’s disease whether she had any belly pain. “She wasn’t answering me, and I thought, ‘Oh great—just another typical teenage girl’” remembers Dr. Weber. “Well, I thought she wasn’t answering me, but she was lifting her eyebrows, which means ‘yes.’ But I didn’t know that.”

Dr. Weber has found nurses and other long-time hospital staff to be very helpful in learning how to communicate with her patient population.

Context and History

Hawgood reminds hospitalists that families often come into hospitals with past histories of things gone wrong.

“The whole healthcare system is so volatile now,” she observes. “People feel rushed, they feel [they are being] rushed out of hospital. They don’t have adequate healthcare insurance; they don’t have adequate care in the community. We send people out with trachs, tube feeds, open wounds, and pain issues. People are dealing with limited money, trying to juggle work, children, and elderly parents. So they have reasons to be angry.”

Families feel frustrated when their loved one is sick, agrees Dr. Baudendistel. “It may be that your role is to just let them vent their frustration.”

Says Hawgood, “I tell the people I train that I have nothing to lose. The patients and their families have everything to lose. So, even if I get off on the wrong foot, I’ll go back and ask, ‘could I start again?’ And usually, people will say, ‘yes.’ It’s up to me to make it work.”

Dr. Weber recalls one family at ANMC with a special needs child who had been in a Seattle hospital, and was readmitted to their facility with kidney stones. He was not getting better and the physicians recommended that the family travel back to Seattle, where a pediatric urologist could remove the stones. The parents were uncomfortable with the recommendation that their son return to Seattle.

“We did need to bring in a mediator, and have several family care conferences with the parents, with social workers and discharge planners, and all involved providers,” says Dr. Weber.

In the course of the conferences, the family revealed that their child’s disabilities were due to a missed diagnosis of meningitis when he was a baby. “They harbored a lot of resentment toward the medical profession in general,” says Dr. Weber. “It was hard to work through that. They couldn’t let it go—and I don’t blame them—and it caused them to always question our motives and our intentions.”

During the care conferences, the team let the family tell their story of the meningitis case again. Just by listening to the family’s history with that event, the team was able to validate the family’s concerns. The parents agreed to take their son to Seattle for the procedure, and later sent a thank you card to the pediatric team at ANMC that had treated him.

Don’t Make Assumptions

Hawgood always cautions physicians to enter the patient’s room with an open mind and to be open to cues and clues about the family’s situation. She praises the UCSF hospitalists’ training of young residents.

“They let them take the lead in patient interviews, then we all discuss how that interview went, and how things could have been done better,” says Hawgood. For instance, she recommends that hospitalists “allow for some silence in the room. You don’t have to fill up every minute with conversation. Look for the non-verbal cues, the things that weren’t said.”

In Dr. Weber’s hospital, pediatric patients come from all over state. It is not unusual for a baby to be in the neonatal intensive care unit for a while before the parents come back to visit. It would be easy to question, she says, whether these people are going to be good parents. “But until you know their social situation, you really have no place saying that,” says Dr. Weber. “You may find that they have six other children at home and cannot be here because they have no other caregivers for their children, and their village is 200 miles away.”

The Best You Can Do

Despite the care team’s best efforts, there will be a few cases, admits Dr. Bennett, where “you just can’t make much headway.” She recalls the case of an elderly man who had had a massive stroke, lived in a nursing home, and had not communicated for years. The man’s daughter was convinced, however, that he communicated with her and was “adamant that everything had to be done. We tried and tried,” explains Dr. Bennett, calling several group meetings and using hospital chaplains as allies, “but she just couldn’t hear it, and couldn’t see it [that her father would not get better]. She was too vested in believing that he did, in fact, communicate with her and that he would get better.”

In such cases the team may have to do the best they can to honor the patient’s and the family member’s value system and help them abide by that.

“There’s one other thing about difficult families and difficult patients: You have such an intense relationship with them that you don’t have with other people,” notes Hawgood. “If you can hang in there, they’re the best relationships you can have. You are so emotionally engaged in trying to make it work. I have chosen to work with hospitalists because of the approach they take. I think it’s the most efficient model you can use in a hospital. We really talk about the goals of care, and what we understand about the patient’s and family’s goals of care. We approach this from the point of view that they deserve care. What can we do to make a difference, so that it works for the patient and the families?” TH

Writer Gretchen Henkel lives in California.

References

• “Number of U.S. Medical Schools Teaching Selected Topics 2003-2004.” Compiled by the American Association of Medical Colleges Institutional Profile System. Available online at: http://services.aamc.org/currdir/section2/03-04hottopics.pdf. Last accessed January 26, 2006.
• General Competencies; ACGME Outcome Project. September, 1999. Available online at: www.acgme.org/outcome/comp/compMin.asp. Last accessed January 27, 2006.

Physician-assisted suicide and euthanasia (PAS/E) are contrary to the 2,500-year-old historic and vitally important professional ethic of caring and healing. The professional ethic of medicine is to care for the patient. Francis Peabody said in 1927, “The secret of caring for the patient is in caring for the patient.”1 This is not a tautology, but a truism. The proper response to a request for physician-assisted suicide or euthanasia is excellent end-of-life care.

The American Medical Association maintains an unequivocal position on this issue: “Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks. Instead of participating in assisted suicide, physicians must aggressively respond to the needs of patients at the end of life ... .”2

In both ancient and modern times some physicians have, on occasion, secretly assisted patients with suicide or have even administered lethal medication themselves when they felt extenuating circumstances justified an exception to the societal standard and the professional rule. Until Jack Kevorkian, MD, it was done in secret because this rule was recognized as valid.

Historically, there have been several periods of time when euthanasia was given serious public debate. But until 1984, when the Royal Dutch Medical Association took the revolutionary position that it was professionally acceptable for a physician to give a lethal injection to a patient under certain clearly defined circumstances, that debate was always silenced by returning to the professional ethic of healing and not killing.

Arguments in Favor of Physician-Assisted Suicide/Euthanasia

In the current debate about the legalization of assisted suicide, supporters offer three major arguments:

1. A patient has a right to self-determination;
2. It is the compassionate thing to do; and
3. It is working in the Netherlands and in Oregon, so we should allow it elsewhere, too.

The first two arguments have remained the same for more than 200 years.3

The right to self-determination: Proponents maintain, correctly, that a patient has a right to accept or refuse any treatment—even if that refusal leads to death. They go on to maintain that the patient should then have the right to request any treatment they want, even medical assistance with bringing about death.

Though a patient has a negative right to be left alone, I believe this does not translate into a positive right (an entitlement) to whatever he or she wants. If that were the case, there would be no need for laws to regulate prescription drugs; a patient could just buy whatever he or she felt was appropriate. Patient autonomy is not absolute any more than is a generic right to personal freedom. The U.S. Supreme Court has found there is no constitutional right to assisted suicide.

Compassion: Supporters of PAS/E often point out that “we shoot horses, don’t we?” implying that our compassionate response to animal suffering should be extended to include human suffering. This is only tenable in a worldview that concludes that there is no moral difference between humans and animals. If you believe, as do most people in Western society, that a) we have a greater obligation to human beings than we do to animals, and that b) human life is special and should be respected and protected whenever possible, then we are obligated to find a better solution to terminal suffering in humans.

Compassion, while perhaps more compelling than self-determination, is still not determinative. As Pellegrino has said, “ ... compassion is a virtue, not a principle. Morally weighty as it is, compassion can become maleficent unless it is constrained by principle.”4 Compassion means “to suffer with.” Compassionate patient care involves coming alongside patients who are suffering, being with them, and doing all we can to alleviate that suffering.

The Dutch example: Other supporters of PAS/E offer a more pragmatic defense of their position, suggesting that the Dutch have proven that regulated euthanasia can work; however, it is not always used as a “last resort.” In nearly 20% of cases available palliative measures were declined by the patient; 60% of cases were not reported truthfully; 50% of cases did not have the required consultation; and—most worrisome of all—25% of patients who were given a lethal injection did not request euthanasia.5

Conversely, only about one-third of patient requests for euthanasia are carried out by Dutch physicians. Thus, two-thirds of patients who request euthanasia are denied it, and one-quarter of patients who are euthanized did not request it, suggesting that it is not patient autonomy that drives the Dutch euthanasia program, but physician autonomy. We must conclude that the Dutch experiment with regulated euthanasia has failed.

Arguments Opposing Physician-Assisted Suicide/Euthanasia

In addition to these rebuttals to those arguments in favor of PAS/E, there are several specific arguments in opposition. These have been well articulated elsewhere.6-8 They will merely be summarized here in two groups:

1. Rule-based arguments: PAS/E goes against longstanding professional virtue and would change the nature of the patient-doctor relationship, perhaps even detracting from efforts at palliative care; and
2. Consequence-based arguments: PAS/E would be bad public policy because regulations cannot prevent abuses and expansions of the “indications” to include coerced “voluntary” PAS/E, surrogate non-voluntary PAS/E for those who have lost decision-making capacity, requests from patients who are suffering (but not terminally ill), and even discriminatory involuntary euthanasia as a cost-control measure.9

The Moral High Ground

If we accept that PAS/E are contrary to physician virtue and moral tradition, and further that legalization of such activities would be bad public policy, what then is the alternative? The alternative is excellent end-of-life care. This requires a commitment to compassion, a willingness to “suffer with” the patient. Good palliative/hospice care has the goal of helping the patient to live each day as well as possible. Patients who receive good end-of-life care rarely request that their physicians hasten death.10

If a terminally ill patient does make such a request, the physician must elicit the reason by saying, “I’m sorry you are suffering. How can I help to make it better?” In addition, the physician should give the patient as much control as possible over treatment options when the patient is ready to shift goals to comfort care. The physician must never say, “There is nothing more I can do for you.” Such a statement represents an immoral abandonment of the patient. Instead the physician should say, “There is nothing more we can do to stop or slow the disease process, but there is a lot more we can do for you.”

All of the patient’s physical needs must be thoroughly addressed. This means intensive symptom control of pain and dyspnea, the two most feared symptoms at the end of life, as well as the multitude of other symptoms experienced by patients as they approach death.

Psychological symptoms are almost universal in dying patients. Anxiety about the future is understandable. Depression is likewise to be expected in a significant percentage of patients. Both need treatment, whether that be drugs, counseling, or someone to sit with the patient. Ramsay has said that people who are dying need only two things, comfort (symptom control) and company (human presence).11

Social issues also need assessment and treatment. Many dying people are lonely. Friends often stop visiting because they are uncomfortable and do not know what to say. Even family members may distance themselves physically and emotionally from a patient who is approaching death. Patients may have “unfinished business” that causes them unspoken distress. Byock has observed that a person who is dying often needs to say one or more of the following five things: “Will you forgive me?” “I forgive you,” “Thank you,” “I love you,” and “Goodbye.”12

The final dimension in whole person care is the spiritual. While this is important in caring for any patient who is seriously ill, it becomes imperative in dying patients. When facing death, patients often ruminate on guilt about how they have lived their lives. Others may develop uncertainty or doubts about even longstanding beliefs. They may have many questions about the meaning of life and the meaning of death.

It is rare indeed that one professional is able to address all of the physical, psychological, social, and spiritual needs of dying patients. It requires a multidisciplinary team including nurses, physicians, therapists, counselors, pastoral care workers, social workers, and lay volunteers. Such a team is usually best mobilized through a formal hospice or palliative care program, but may at times be coordinated through a primary care physician’s office or a community or church organization.

The Imperative for Good Pain Management

In spite of excellent resources too numerous to cite, and in spite of practice guidelines and quality improvement guidelines, pain management is often inadequate.13-15 JCAHO has issued pain management standards that affirm both the patient’s right to appropriate assessment and management of pain and the institution’s responsibilities.16

Perhaps the most commonly asked ethical question about pain management at the end of life is concern about the inadvertent—or even the intentional—suppression of respiration with the use of high doses of opioids that could lead to an earlier death. Experts in pain management maintain that this rarely—if ever—happens because pain is a good respiratory stimulant. Even with good empiric evidence that narcotic use does not hasten death, this myth continues to discourage many physicians from fulfilling their obligation to relieve suffering.17

But let us consider the worst-case scenario: What if a terminally ill patient with overwhelming pain requires rapidly increasing doses of narcotics and does actually suffers from respiratory depression. Is the physician morally obligated to use ventilatory support to overcome this side effect? Thomas Aquinas (1224-1274) answered this question with his “rule of double effect”: It is morally permissible to do an act that has both a good effect and a bad effect if all of the following conditions exist:

1. The act must be inherently good, or at least morally neutral;
2. The bad effect may be anticipated, but not intended;
3. The good effect must not be achieved by means of the bad effect; and
4. There must be a proportionately grave reason for allowing the bad effect.

Using high doses of narcotics to relieve pain fits these criteria.

Terminal Sedation

Because of the continued legal and professional proscription against PAS/E, some have proposed the use of “terminal sedation”: the practice of giving sedation to a patient who is dying, expecting that he or she will die more quickly of dehydration. If the intention is clearly to hasten death, then this is euthanasia and, in my estimation, it is an immoral end-run around the current legal and professional prohibitions. If, however, maximal efforts have failed to adequately relieve the suffering of an imminently dying patient, it would be ethically permissible to render the patient unconscious in order to relieve pain, accepting the unintended side effect of an earlier death from dehydration. This too would be justifiable using the rule of double effect.

Conclusion

PSA/E have been outside the bounds of acceptable behavior for physicians for hundreds of years. The moral, legal, and professional acceptable alternative is excellent end-of-life care. TH

To cure, sometimes; to heal, often; to comfort, always.—15th century French proverb.

Dr. Orr is a clinical ethicist at the Fletcher Allen Health Care in Burlington, Vt.

References

1. Peabody F. The care of the patient. JAMA. 1927;88:877-882.
2. Code of Medical Ethics, AMA (1994). Opinion 2.211 “Physician Assisted Suicide”: 51.
3. Emanuel EJ. The history of euthanasia debates in the United States and Britain. Ann Intern Med. 1994;121(10):793-802.
4. Pellegrino ED. Compassion needs reason too. JAMA. 1993;270(7):870-873.
5. Jochemsen H, Keown J. Voluntary euthanasia under control? Further empirical evidence from the Netherlands. J Med Ethics. 1999;25(1):16-21.
6. Kass LR. Neither for love nor money: why doctors must not kill. The Public Interest. 1989;94:25-46.
7. Callahan D. When self-determination runs amok. Hastings Center Report. 1992;22(2):52-55.
8. Singer PA, Siegler M. Euthanasia—a critique. N Eng J Med. 1990;322(26):1881-1883.
9. Hendin H. Selling death and dignity. Hastings Center Report. 1995;25(3):19-23.
10. Brown JH, Hentelheff P, Barakat S, et al. Is it normal for terminally ill patients to desire death? Am J Psych. 1986;143(2):208-211.
11. Ramsay P. The Patient as Person. New Haven, Conn.: Yale University Press; 1970:113-164.
12. Byock I. The nature of suffering and the nature of opportunity at the end of life. Clin Geriatr Med. 1996;12(2):237-252.
13. Agency for Health Care Policy and Research. Management of Cancer Pain. Rockville, Md.: U.S. Department of Health and Human Services, 1994
14. American Pain Society Quality of Care Committee. Quality improvement guidelines for the treatment of acute pain and cancer pain. JAMA. 1995;274(23):1874-1880.
15. Cleeland CS. Undertreatment of cancer pain in elderly patients. JAMA. 1998;279(23):1914-1915.
16. Phillips DM. JACHO pain management standards are unveiled. JAMA. 2000;284(4):428-429.
17. Thorns A, Sykes N. Opioid use in the last week of life and implications for end-of-life decision making. Lancet. 2000;356:398-399.

Physician-assisted suicide and euthanasia (PAS/E) are contrary to the 2,500-year-old historic and vitally important professional ethic of caring and healing. The professional ethic of medicine is to care for the patient. Francis Peabody said in 1927, “The secret of caring for the patient is in caring for the patient.”1 This is not a tautology, but a truism. The proper response to a request for physician-assisted suicide or euthanasia is excellent end-of-life care.

The American Medical Association maintains an unequivocal position on this issue: “Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks. Instead of participating in assisted suicide, physicians must aggressively respond to the needs of patients at the end of life ... .”2

In both ancient and modern times some physicians have, on occasion, secretly assisted patients with suicide or have even administered lethal medication themselves when they felt extenuating circumstances justified an exception to the societal standard and the professional rule. Until Jack Kevorkian, MD, it was done in secret because this rule was recognized as valid.

Historically, there have been several periods of time when euthanasia was given serious public debate. But until 1984, when the Royal Dutch Medical Association took the revolutionary position that it was professionally acceptable for a physician to give a lethal injection to a patient under certain clearly defined circumstances, that debate was always silenced by returning to the professional ethic of healing and not killing.

Arguments in Favor of Physician-Assisted Suicide/Euthanasia

In the current debate about the legalization of assisted suicide, supporters offer three major arguments:

1. A patient has a right to self-determination;
2. It is the compassionate thing to do; and
3. It is working in the Netherlands and in Oregon, so we should allow it elsewhere, too.

The first two arguments have remained the same for more than 200 years.3

The right to self-determination: Proponents maintain, correctly, that a patient has a right to accept or refuse any treatment—even if that refusal leads to death. They go on to maintain that the patient should then have the right to request any treatment they want, even medical assistance with bringing about death.

Though a patient has a negative right to be left alone, I believe this does not translate into a positive right (an entitlement) to whatever he or she wants. If that were the case, there would be no need for laws to regulate prescription drugs; a patient could just buy whatever he or she felt was appropriate. Patient autonomy is not absolute any more than is a generic right to personal freedom. The U.S. Supreme Court has found there is no constitutional right to assisted suicide.

Compassion: Supporters of PAS/E often point out that “we shoot horses, don’t we?” implying that our compassionate response to animal suffering should be extended to include human suffering. This is only tenable in a worldview that concludes that there is no moral difference between humans and animals. If you believe, as do most people in Western society, that a) we have a greater obligation to human beings than we do to animals, and that b) human life is special and should be respected and protected whenever possible, then we are obligated to find a better solution to terminal suffering in humans.

Compassion, while perhaps more compelling than self-determination, is still not determinative. As Pellegrino has said, “ ... compassion is a virtue, not a principle. Morally weighty as it is, compassion can become maleficent unless it is constrained by principle.”4 Compassion means “to suffer with.” Compassionate patient care involves coming alongside patients who are suffering, being with them, and doing all we can to alleviate that suffering.

The Dutch example: Other supporters of PAS/E offer a more pragmatic defense of their position, suggesting that the Dutch have proven that regulated euthanasia can work; however, it is not always used as a “last resort.” In nearly 20% of cases available palliative measures were declined by the patient; 60% of cases were not reported truthfully; 50% of cases did not have the required consultation; and—most worrisome of all—25% of patients who were given a lethal injection did not request euthanasia.5

Conversely, only about one-third of patient requests for euthanasia are carried out by Dutch physicians. Thus, two-thirds of patients who request euthanasia are denied it, and one-quarter of patients who are euthanized did not request it, suggesting that it is not patient autonomy that drives the Dutch euthanasia program, but physician autonomy. We must conclude that the Dutch experiment with regulated euthanasia has failed.

Arguments Opposing Physician-Assisted Suicide/Euthanasia

In addition to these rebuttals to those arguments in favor of PAS/E, there are several specific arguments in opposition. These have been well articulated elsewhere.6-8 They will merely be summarized here in two groups:

1. Rule-based arguments: PAS/E goes against longstanding professional virtue and would change the nature of the patient-doctor relationship, perhaps even detracting from efforts at palliative care; and
2. Consequence-based arguments: PAS/E would be bad public policy because regulations cannot prevent abuses and expansions of the “indications” to include coerced “voluntary” PAS/E, surrogate non-voluntary PAS/E for those who have lost decision-making capacity, requests from patients who are suffering (but not terminally ill), and even discriminatory involuntary euthanasia as a cost-control measure.9

The Moral High Ground

If we accept that PAS/E are contrary to physician virtue and moral tradition, and further that legalization of such activities would be bad public policy, what then is the alternative? The alternative is excellent end-of-life care. This requires a commitment to compassion, a willingness to “suffer with” the patient. Good palliative/hospice care has the goal of helping the patient to live each day as well as possible. Patients who receive good end-of-life care rarely request that their physicians hasten death.10

If a terminally ill patient does make such a request, the physician must elicit the reason by saying, “I’m sorry you are suffering. How can I help to make it better?” In addition, the physician should give the patient as much control as possible over treatment options when the patient is ready to shift goals to comfort care. The physician must never say, “There is nothing more I can do for you.” Such a statement represents an immoral abandonment of the patient. Instead the physician should say, “There is nothing more we can do to stop or slow the disease process, but there is a lot more we can do for you.”

All of the patient’s physical needs must be thoroughly addressed. This means intensive symptom control of pain and dyspnea, the two most feared symptoms at the end of life, as well as the multitude of other symptoms experienced by patients as they approach death.

Psychological symptoms are almost universal in dying patients. Anxiety about the future is understandable. Depression is likewise to be expected in a significant percentage of patients. Both need treatment, whether that be drugs, counseling, or someone to sit with the patient. Ramsay has said that people who are dying need only two things, comfort (symptom control) and company (human presence).11

Social issues also need assessment and treatment. Many dying people are lonely. Friends often stop visiting because they are uncomfortable and do not know what to say. Even family members may distance themselves physically and emotionally from a patient who is approaching death. Patients may have “unfinished business” that causes them unspoken distress. Byock has observed that a person who is dying often needs to say one or more of the following five things: “Will you forgive me?” “I forgive you,” “Thank you,” “I love you,” and “Goodbye.”12

The final dimension in whole person care is the spiritual. While this is important in caring for any patient who is seriously ill, it becomes imperative in dying patients. When facing death, patients often ruminate on guilt about how they have lived their lives. Others may develop uncertainty or doubts about even longstanding beliefs. They may have many questions about the meaning of life and the meaning of death.

It is rare indeed that one professional is able to address all of the physical, psychological, social, and spiritual needs of dying patients. It requires a multidisciplinary team including nurses, physicians, therapists, counselors, pastoral care workers, social workers, and lay volunteers. Such a team is usually best mobilized through a formal hospice or palliative care program, but may at times be coordinated through a primary care physician’s office or a community or church organization.

The Imperative for Good Pain Management

In spite of excellent resources too numerous to cite, and in spite of practice guidelines and quality improvement guidelines, pain management is often inadequate.13-15 JCAHO has issued pain management standards that affirm both the patient’s right to appropriate assessment and management of pain and the institution’s responsibilities.16

Perhaps the most commonly asked ethical question about pain management at the end of life is concern about the inadvertent—or even the intentional—suppression of respiration with the use of high doses of opioids that could lead to an earlier death. Experts in pain management maintain that this rarely—if ever—happens because pain is a good respiratory stimulant. Even with good empiric evidence that narcotic use does not hasten death, this myth continues to discourage many physicians from fulfilling their obligation to relieve suffering.17

But let us consider the worst-case scenario: What if a terminally ill patient with overwhelming pain requires rapidly increasing doses of narcotics and does actually suffers from respiratory depression. Is the physician morally obligated to use ventilatory support to overcome this side effect? Thomas Aquinas (1224-1274) answered this question with his “rule of double effect”: It is morally permissible to do an act that has both a good effect and a bad effect if all of the following conditions exist:

1. The act must be inherently good, or at least morally neutral;
2. The bad effect may be anticipated, but not intended;
3. The good effect must not be achieved by means of the bad effect; and
4. There must be a proportionately grave reason for allowing the bad effect.

Using high doses of narcotics to relieve pain fits these criteria.

Terminal Sedation

Because of the continued legal and professional proscription against PAS/E, some have proposed the use of “terminal sedation”: the practice of giving sedation to a patient who is dying, expecting that he or she will die more quickly of dehydration. If the intention is clearly to hasten death, then this is euthanasia and, in my estimation, it is an immoral end-run around the current legal and professional prohibitions. If, however, maximal efforts have failed to adequately relieve the suffering of an imminently dying patient, it would be ethically permissible to render the patient unconscious in order to relieve pain, accepting the unintended side effect of an earlier death from dehydration. This too would be justifiable using the rule of double effect.

Conclusion

PSA/E have been outside the bounds of acceptable behavior for physicians for hundreds of years. The moral, legal, and professional acceptable alternative is excellent end-of-life care. TH

To cure, sometimes; to heal, often; to comfort, always.—15th century French proverb.

Dr. Orr is a clinical ethicist at the Fletcher Allen Health Care in Burlington, Vt.

References

1. Peabody F. The care of the patient. JAMA. 1927;88:877-882.
2. Code of Medical Ethics, AMA (1994). Opinion 2.211 “Physician Assisted Suicide”: 51.
3. Emanuel EJ. The history of euthanasia debates in the United States and Britain. Ann Intern Med. 1994;121(10):793-802.
4. Pellegrino ED. Compassion needs reason too. JAMA. 1993;270(7):870-873.
5. Jochemsen H, Keown J. Voluntary euthanasia under control? Further empirical evidence from the Netherlands. J Med Ethics. 1999;25(1):16-21.
6. Kass LR. Neither for love nor money: why doctors must not kill. The Public Interest. 1989;94:25-46.
7. Callahan D. When self-determination runs amok. Hastings Center Report. 1992;22(2):52-55.
8. Singer PA, Siegler M. Euthanasia—a critique. N Eng J Med. 1990;322(26):1881-1883.
9. Hendin H. Selling death and dignity. Hastings Center Report. 1995;25(3):19-23.
10. Brown JH, Hentelheff P, Barakat S, et al. Is it normal for terminally ill patients to desire death? Am J Psych. 1986;143(2):208-211.
11. Ramsay P. The Patient as Person. New Haven, Conn.: Yale University Press; 1970:113-164.
12. Byock I. The nature of suffering and the nature of opportunity at the end of life. Clin Geriatr Med. 1996;12(2):237-252.
13. Agency for Health Care Policy and Research. Management of Cancer Pain. Rockville, Md.: U.S. Department of Health and Human Services, 1994
14. American Pain Society Quality of Care Committee. Quality improvement guidelines for the treatment of acute pain and cancer pain. JAMA. 1995;274(23):1874-1880.
15. Cleeland CS. Undertreatment of cancer pain in elderly patients. JAMA. 1998;279(23):1914-1915.
16. Phillips DM. JACHO pain management standards are unveiled. JAMA. 2000;284(4):428-429.
17. Thorns A, Sykes N. Opioid use in the last week of life and implications for end-of-life decision making. Lancet. 2000;356:398-399.

Physician-assisted suicide and euthanasia (PAS/E) are contrary to the 2,500-year-old historic and vitally important professional ethic of caring and healing. The professional ethic of medicine is to care for the patient. Francis Peabody said in 1927, “The secret of caring for the patient is in caring for the patient.”1 This is not a tautology, but a truism. The proper response to a request for physician-assisted suicide or euthanasia is excellent end-of-life care.

The American Medical Association maintains an unequivocal position on this issue: “Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks. Instead of participating in assisted suicide, physicians must aggressively respond to the needs of patients at the end of life ... .”2

In both ancient and modern times some physicians have, on occasion, secretly assisted patients with suicide or have even administered lethal medication themselves when they felt extenuating circumstances justified an exception to the societal standard and the professional rule. Until Jack Kevorkian, MD, it was done in secret because this rule was recognized as valid.

Historically, there have been several periods of time when euthanasia was given serious public debate. But until 1984, when the Royal Dutch Medical Association took the revolutionary position that it was professionally acceptable for a physician to give a lethal injection to a patient under certain clearly defined circumstances, that debate was always silenced by returning to the professional ethic of healing and not killing.

Arguments in Favor of Physician-Assisted Suicide/Euthanasia

In the current debate about the legalization of assisted suicide, supporters offer three major arguments:

1. A patient has a right to self-determination;
2. It is the compassionate thing to do; and
3. It is working in the Netherlands and in Oregon, so we should allow it elsewhere, too.

The first two arguments have remained the same for more than 200 years.3

The right to self-determination: Proponents maintain, correctly, that a patient has a right to accept or refuse any treatment—even if that refusal leads to death. They go on to maintain that the patient should then have the right to request any treatment they want, even medical assistance with bringing about death.

Though a patient has a negative right to be left alone, I believe this does not translate into a positive right (an entitlement) to whatever he or she wants. If that were the case, there would be no need for laws to regulate prescription drugs; a patient could just buy whatever he or she felt was appropriate. Patient autonomy is not absolute any more than is a generic right to personal freedom. The U.S. Supreme Court has found there is no constitutional right to assisted suicide.

Compassion: Supporters of PAS/E often point out that “we shoot horses, don’t we?” implying that our compassionate response to animal suffering should be extended to include human suffering. This is only tenable in a worldview that concludes that there is no moral difference between humans and animals. If you believe, as do most people in Western society, that a) we have a greater obligation to human beings than we do to animals, and that b) human life is special and should be respected and protected whenever possible, then we are obligated to find a better solution to terminal suffering in humans.

Compassion, while perhaps more compelling than self-determination, is still not determinative. As Pellegrino has said, “ ... compassion is a virtue, not a principle. Morally weighty as it is, compassion can become maleficent unless it is constrained by principle.”4 Compassion means “to suffer with.” Compassionate patient care involves coming alongside patients who are suffering, being with them, and doing all we can to alleviate that suffering.

The Dutch example: Other supporters of PAS/E offer a more pragmatic defense of their position, suggesting that the Dutch have proven that regulated euthanasia can work; however, it is not always used as a “last resort.” In nearly 20% of cases available palliative measures were declined by the patient; 60% of cases were not reported truthfully; 50% of cases did not have the required consultation; and—most worrisome of all—25% of patients who were given a lethal injection did not request euthanasia.5

Conversely, only about one-third of patient requests for euthanasia are carried out by Dutch physicians. Thus, two-thirds of patients who request euthanasia are denied it, and one-quarter of patients who are euthanized did not request it, suggesting that it is not patient autonomy that drives the Dutch euthanasia program, but physician autonomy. We must conclude that the Dutch experiment with regulated euthanasia has failed.

Arguments Opposing Physician-Assisted Suicide/Euthanasia

In addition to these rebuttals to those arguments in favor of PAS/E, there are several specific arguments in opposition. These have been well articulated elsewhere.6-8 They will merely be summarized here in two groups:

1. Rule-based arguments: PAS/E goes against longstanding professional virtue and would change the nature of the patient-doctor relationship, perhaps even detracting from efforts at palliative care; and
2. Consequence-based arguments: PAS/E would be bad public policy because regulations cannot prevent abuses and expansions of the “indications” to include coerced “voluntary” PAS/E, surrogate non-voluntary PAS/E for those who have lost decision-making capacity, requests from patients who are suffering (but not terminally ill), and even discriminatory involuntary euthanasia as a cost-control measure.9

The Moral High Ground

If we accept that PAS/E are contrary to physician virtue and moral tradition, and further that legalization of such activities would be bad public policy, what then is the alternative? The alternative is excellent end-of-life care. This requires a commitment to compassion, a willingness to “suffer with” the patient. Good palliative/hospice care has the goal of helping the patient to live each day as well as possible. Patients who receive good end-of-life care rarely request that their physicians hasten death.10

If a terminally ill patient does make such a request, the physician must elicit the reason by saying, “I’m sorry you are suffering. How can I help to make it better?” In addition, the physician should give the patient as much control as possible over treatment options when the patient is ready to shift goals to comfort care. The physician must never say, “There is nothing more I can do for you.” Such a statement represents an immoral abandonment of the patient. Instead the physician should say, “There is nothing more we can do to stop or slow the disease process, but there is a lot more we can do for you.”

All of the patient’s physical needs must be thoroughly addressed. This means intensive symptom control of pain and dyspnea, the two most feared symptoms at the end of life, as well as the multitude of other symptoms experienced by patients as they approach death.

Psychological symptoms are almost universal in dying patients. Anxiety about the future is understandable. Depression is likewise to be expected in a significant percentage of patients. Both need treatment, whether that be drugs, counseling, or someone to sit with the patient. Ramsay has said that people who are dying need only two things, comfort (symptom control) and company (human presence).11

Social issues also need assessment and treatment. Many dying people are lonely. Friends often stop visiting because they are uncomfortable and do not know what to say. Even family members may distance themselves physically and emotionally from a patient who is approaching death. Patients may have “unfinished business” that causes them unspoken distress. Byock has observed that a person who is dying often needs to say one or more of the following five things: “Will you forgive me?” “I forgive you,” “Thank you,” “I love you,” and “Goodbye.”12

The final dimension in whole person care is the spiritual. While this is important in caring for any patient who is seriously ill, it becomes imperative in dying patients. When facing death, patients often ruminate on guilt about how they have lived their lives. Others may develop uncertainty or doubts about even longstanding beliefs. They may have many questions about the meaning of life and the meaning of death.

It is rare indeed that one professional is able to address all of the physical, psychological, social, and spiritual needs of dying patients. It requires a multidisciplinary team including nurses, physicians, therapists, counselors, pastoral care workers, social workers, and lay volunteers. Such a team is usually best mobilized through a formal hospice or palliative care program, but may at times be coordinated through a primary care physician’s office or a community or church organization.

The Imperative for Good Pain Management

In spite of excellent resources too numerous to cite, and in spite of practice guidelines and quality improvement guidelines, pain management is often inadequate.13-15 JCAHO has issued pain management standards that affirm both the patient’s right to appropriate assessment and management of pain and the institution’s responsibilities.16

Perhaps the most commonly asked ethical question about pain management at the end of life is concern about the inadvertent—or even the intentional—suppression of respiration with the use of high doses of opioids that could lead to an earlier death. Experts in pain management maintain that this rarely—if ever—happens because pain is a good respiratory stimulant. Even with good empiric evidence that narcotic use does not hasten death, this myth continues to discourage many physicians from fulfilling their obligation to relieve suffering.17

But let us consider the worst-case scenario: What if a terminally ill patient with overwhelming pain requires rapidly increasing doses of narcotics and does actually suffers from respiratory depression. Is the physician morally obligated to use ventilatory support to overcome this side effect? Thomas Aquinas (1224-1274) answered this question with his “rule of double effect”: It is morally permissible to do an act that has both a good effect and a bad effect if all of the following conditions exist:

1. The act must be inherently good, or at least morally neutral;
2. The bad effect may be anticipated, but not intended;
3. The good effect must not be achieved by means of the bad effect; and
4. There must be a proportionately grave reason for allowing the bad effect.

Using high doses of narcotics to relieve pain fits these criteria.

Terminal Sedation

Because of the continued legal and professional proscription against PAS/E, some have proposed the use of “terminal sedation”: the practice of giving sedation to a patient who is dying, expecting that he or she will die more quickly of dehydration. If the intention is clearly to hasten death, then this is euthanasia and, in my estimation, it is an immoral end-run around the current legal and professional prohibitions. If, however, maximal efforts have failed to adequately relieve the suffering of an imminently dying patient, it would be ethically permissible to render the patient unconscious in order to relieve pain, accepting the unintended side effect of an earlier death from dehydration. This too would be justifiable using the rule of double effect.

Conclusion

PSA/E have been outside the bounds of acceptable behavior for physicians for hundreds of years. The moral, legal, and professional acceptable alternative is excellent end-of-life care. TH

To cure, sometimes; to heal, often; to comfort, always.—15th century French proverb.

Dr. Orr is a clinical ethicist at the Fletcher Allen Health Care in Burlington, Vt.

References

1. Peabody F. The care of the patient. JAMA. 1927;88:877-882.
2. Code of Medical Ethics, AMA (1994). Opinion 2.211 “Physician Assisted Suicide”: 51.
3. Emanuel EJ. The history of euthanasia debates in the United States and Britain. Ann Intern Med. 1994;121(10):793-802.
4. Pellegrino ED. Compassion needs reason too. JAMA. 1993;270(7):870-873.
5. Jochemsen H, Keown J. Voluntary euthanasia under control? Further empirical evidence from the Netherlands. J Med Ethics. 1999;25(1):16-21.
6. Kass LR. Neither for love nor money: why doctors must not kill. The Public Interest. 1989;94:25-46.
7. Callahan D. When self-determination runs amok. Hastings Center Report. 1992;22(2):52-55.
8. Singer PA, Siegler M. Euthanasia—a critique. N Eng J Med. 1990;322(26):1881-1883.
9. Hendin H. Selling death and dignity. Hastings Center Report. 1995;25(3):19-23.
10. Brown JH, Hentelheff P, Barakat S, et al. Is it normal for terminally ill patients to desire death? Am J Psych. 1986;143(2):208-211.
11. Ramsay P. The Patient as Person. New Haven, Conn.: Yale University Press; 1970:113-164.
12. Byock I. The nature of suffering and the nature of opportunity at the end of life. Clin Geriatr Med. 1996;12(2):237-252.
13. Agency for Health Care Policy and Research. Management of Cancer Pain. Rockville, Md.: U.S. Department of Health and Human Services, 1994
14. American Pain Society Quality of Care Committee. Quality improvement guidelines for the treatment of acute pain and cancer pain. JAMA. 1995;274(23):1874-1880.
15. Cleeland CS. Undertreatment of cancer pain in elderly patients. JAMA. 1998;279(23):1914-1915.
16. Phillips DM. JACHO pain management standards are unveiled. JAMA. 2000;284(4):428-429.
17. Thorns A, Sykes N. Opioid use in the last week of life and implications for end-of-life decision making. Lancet. 2000;356:398-399.

Two new insulin products were recently FDA-approved, Exubera (inhaled human insulin, Pfizer/Nektar) and Levemir (insulin detemir, Novo Nordisk). These new insulins are important to hospitalists because admitted patients may be receiving them, patients may ask about them, and other members of the healthcare team may have questions, as well.

Nektar Therapeutics has been developing noninvasive macromolecules for inhaled delivery systems for many years. To develop Exubera (their first FDA-approved product), they collaborated with Pfizer and Sanofi-Aventis. Other Nektar products are not as far along in the U.S. drug approval process.

Exubera (inhalation powder, insulin human) was FDA-approved on January 27, 2006, and is expected to be on pharmacy shelves in June or July of this year. Exubera was also recently approved in Europe but is not available there yet, either. Exubera is short-acting and was approved for use in Types 1 and 2 diabetes mellitus in conjunction with oral agents, or with a basal insulin for basal/bolus dosing.

Peak Exubera levels occur in ~49 minutes (range 30-90 minutes) compared with regular insulin with a peak in 105 minutes (range, 60-240 minutes). In an open-label, 12-week, randomized, controlled trial Exubera improved glycemic control when substituted for or added to oral combination therapy (n=309) in adult Type 2 diabetes patients. There was a small decrease in HbA1c of ~1.4% in the Exubera-treated monotherapy patients. When Exubera was combined with two oral agents (an insulin sensitizer and a secretagogue), the HbA1c decreased ~1.9%. Patients who used only oral agents had an insignificant decrease in HbA1c (0.2%).

Investigators offered Types 1 and 2 diabetics open-label use of inhaled insulin for up to four years. The patients have maintained long-term glycemic control.

The Exubera inhaler device weighs 4 ounces and is about the size of a closed eyeglass case. Carrying the device may be problematic for some because of its size. Common side effects include cough, shortness of breath, sore throat, dry mouth, and hypoglycemia. Exubera is not recommended for 1) patients who have recently quit smoking (within six months); 2) current smokers; 3) asthmatics; or 4) those with bronchitis or emphysema.

Because Exubera is a new product that has not been available in other countries, its long-term safety is unknown. Pfizer is, however, committed to long-term safety and efficacy studies. Monitoring parameters specific to Exubera include: 1) baseline pulmonary function tests (PFTs); and 2) follow-up PFTs every six-12 months until more is known about the drug’s pulmonary safety.

The Word on the Street

Exubera’s manufacturers will likely target this agent to the population that will provide them with the greatest market potential (largest profit). Likely candidates will be those with poorly controlled diabetes on >2 oral agents; these patients will likely need more than another oral agent to improve their glycemic control. Pfizer may choose to market Exubera against insulin sensitizers such as rosiglitazone or pioglitazone —especially when it comes to pharmacoeconomics because the ‘glitazones are not yet available generically and are thus higher cost items.

Ease of use for Exubera versus injected insulin may be the sole advantage for this new agent. Some say that if Exubera is used as a tool for diabetics to get insulin treatment earlier (versus injected insulin), diabetic complications may be minimized; however, medication compliance will play a large role. The medical literature is full of articles regarding non-compliance/non-adherence with asthma inhalers, including improper inhaler use and non-use of these devices. So unless inhaled insulin can significantly improve outcomes compared with the inexpensive injections and other available therapies (e.g., insulin sensitizers), its place on health-system formularies may be limited at best.

Another Inhaled Option

Novo Nordisk received initial FDA approval for its long-acting, basal insulin analog—insulin detemir—on June 17, 2005. Subsequent approval for use in the pediatric population came on October 20, 2005. Levemir is expected on U.S. pharmacy shelves any day. Levemir has been approved in 53 countries worldwide, and has been available in Europe since March 2004.

Levemir is a basal insulin, similar to Lantus (glargine, Sanofi-Aventis), and is approved for use in adults with Types 1 and 2 diabetes and in children with Type 1 diabetes.

It is recommended that Levemir be dosed once- or twice-daily subcutaneously. Pharmacokinetically Levemir has a relatively flat action profile with a mean duration of action ranging between 5.7–23.2 hours (data from clinical trials). Following subcutaneous administration, insulin detemir has a slower, more prolonged absorption over 24 hours compared with NPH insulin. Maximum serum concentrations occur within six to eight hours following administration.

A common side effect of insulin therapies is hypoglycemia. Other side effects common to human insulins include allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. A beneficial effect obtained in some of the Levemir clinical studies was weight loss (0.2 to 0.3-kg), which occurred in several Type 1 patients. Comparatively, the Type 1 patients who received NPH insulin noted weight gain (0.4 to 1.4-kg) over the six-12 month timeframe.

There are no specific monitoring parameters for insulin detemir, except for general management of the diabetic patient (e.g., fasting blood sugar, glycosylated hemoglobin, eye exam, podiatry).

At its launch, insulin detemir will be available in 10mL vials as well as in the Levemir FlexPen. The FlexPen will require the use of NovoFine 30- or 31-gauge disposable needles. TH

Michele Kaufman is based in New York City.

References—Exubera

• Hollander PA, Blonde L, Rowe R, et al. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with Type 2 diabetes: Results of a 6-month, randomized, comparative trial. Diabetes Care. 2004;27:2356-2362.
• Skyler JS, Weinstock RS, Raskin P, et al. The Inhaled Insulin Phase III Type 1 Diabetes Study Group. Use of inhaled insulin in a basal/bolus insulin regimen in Type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care. 2005 Jul:28(7):1630-1635.
• Rosenstock J, Zinman B, Murphy LJ, et al. Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in Type 2 Diabetes—a randomized, controlled trial. Ann Intern Med. 2005 Oct 18;143(8):549-588.
• The Pink Sheet, February 14, 2006; Volume 68, Number 7.Available at www.fda.gov/bbs/topics/news/2006/NEW01304.html. Last accessed March 8, 2006.

References—Levemir

• Levemir (insulin detemir [rDNA origin] injection) package insert. Novo Nordisk, Inc. Princeton, NJ; October 2005.
• Goldman JD, Lee KW. Insulin detemir—a new basal insulin analog. nn Pharmacother. 2005;39:502-507.
• Home P, Bartley P, Russell-Jones D, et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with Type 1 diabetes—a randomized clinical trial. Diabetes Care. 2004;27:1081-1087. Available at http://press.novonordisk-us.com/internal.aspx?rid=318. Last accessed March 1, 2006.

Two new insulin products were recently FDA-approved, Exubera (inhaled human insulin, Pfizer/Nektar) and Levemir (insulin detemir, Novo Nordisk). These new insulins are important to hospitalists because admitted patients may be receiving them, patients may ask about them, and other members of the healthcare team may have questions, as well.

Nektar Therapeutics has been developing noninvasive macromolecules for inhaled delivery systems for many years. To develop Exubera (their first FDA-approved product), they collaborated with Pfizer and Sanofi-Aventis. Other Nektar products are not as far along in the U.S. drug approval process.

Exubera (inhalation powder, insulin human) was FDA-approved on January 27, 2006, and is expected to be on pharmacy shelves in June or July of this year. Exubera was also recently approved in Europe but is not available there yet, either. Exubera is short-acting and was approved for use in Types 1 and 2 diabetes mellitus in conjunction with oral agents, or with a basal insulin for basal/bolus dosing.

Peak Exubera levels occur in ~49 minutes (range 30-90 minutes) compared with regular insulin with a peak in 105 minutes (range, 60-240 minutes). In an open-label, 12-week, randomized, controlled trial Exubera improved glycemic control when substituted for or added to oral combination therapy (n=309) in adult Type 2 diabetes patients. There was a small decrease in HbA1c of ~1.4% in the Exubera-treated monotherapy patients. When Exubera was combined with two oral agents (an insulin sensitizer and a secretagogue), the HbA1c decreased ~1.9%. Patients who used only oral agents had an insignificant decrease in HbA1c (0.2%).

Investigators offered Types 1 and 2 diabetics open-label use of inhaled insulin for up to four years. The patients have maintained long-term glycemic control.

The Exubera inhaler device weighs 4 ounces and is about the size of a closed eyeglass case. Carrying the device may be problematic for some because of its size. Common side effects include cough, shortness of breath, sore throat, dry mouth, and hypoglycemia. Exubera is not recommended for 1) patients who have recently quit smoking (within six months); 2) current smokers; 3) asthmatics; or 4) those with bronchitis or emphysema.

Because Exubera is a new product that has not been available in other countries, its long-term safety is unknown. Pfizer is, however, committed to long-term safety and efficacy studies. Monitoring parameters specific to Exubera include: 1) baseline pulmonary function tests (PFTs); and 2) follow-up PFTs every six-12 months until more is known about the drug’s pulmonary safety.

The Word on the Street

Exubera’s manufacturers will likely target this agent to the population that will provide them with the greatest market potential (largest profit). Likely candidates will be those with poorly controlled diabetes on >2 oral agents; these patients will likely need more than another oral agent to improve their glycemic control. Pfizer may choose to market Exubera against insulin sensitizers such as rosiglitazone or pioglitazone —especially when it comes to pharmacoeconomics because the ‘glitazones are not yet available generically and are thus higher cost items.

Ease of use for Exubera versus injected insulin may be the sole advantage for this new agent. Some say that if Exubera is used as a tool for diabetics to get insulin treatment earlier (versus injected insulin), diabetic complications may be minimized; however, medication compliance will play a large role. The medical literature is full of articles regarding non-compliance/non-adherence with asthma inhalers, including improper inhaler use and non-use of these devices. So unless inhaled insulin can significantly improve outcomes compared with the inexpensive injections and other available therapies (e.g., insulin sensitizers), its place on health-system formularies may be limited at best.

Another Inhaled Option

Novo Nordisk received initial FDA approval for its long-acting, basal insulin analog—insulin detemir—on June 17, 2005. Subsequent approval for use in the pediatric population came on October 20, 2005. Levemir is expected on U.S. pharmacy shelves any day. Levemir has been approved in 53 countries worldwide, and has been available in Europe since March 2004.

Levemir is a basal insulin, similar to Lantus (glargine, Sanofi-Aventis), and is approved for use in adults with Types 1 and 2 diabetes and in children with Type 1 diabetes.

It is recommended that Levemir be dosed once- or twice-daily subcutaneously. Pharmacokinetically Levemir has a relatively flat action profile with a mean duration of action ranging between 5.7–23.2 hours (data from clinical trials). Following subcutaneous administration, insulin detemir has a slower, more prolonged absorption over 24 hours compared with NPH insulin. Maximum serum concentrations occur within six to eight hours following administration.

A common side effect of insulin therapies is hypoglycemia. Other side effects common to human insulins include allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. A beneficial effect obtained in some of the Levemir clinical studies was weight loss (0.2 to 0.3-kg), which occurred in several Type 1 patients. Comparatively, the Type 1 patients who received NPH insulin noted weight gain (0.4 to 1.4-kg) over the six-12 month timeframe.

There are no specific monitoring parameters for insulin detemir, except for general management of the diabetic patient (e.g., fasting blood sugar, glycosylated hemoglobin, eye exam, podiatry).

At its launch, insulin detemir will be available in 10mL vials as well as in the Levemir FlexPen. The FlexPen will require the use of NovoFine 30- or 31-gauge disposable needles. TH

Michele Kaufman is based in New York City.

References—Exubera

• Hollander PA, Blonde L, Rowe R, et al. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with Type 2 diabetes: Results of a 6-month, randomized, comparative trial. Diabetes Care. 2004;27:2356-2362.
• Skyler JS, Weinstock RS, Raskin P, et al. The Inhaled Insulin Phase III Type 1 Diabetes Study Group. Use of inhaled insulin in a basal/bolus insulin regimen in Type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care. 2005 Jul:28(7):1630-1635.
• Rosenstock J, Zinman B, Murphy LJ, et al. Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in Type 2 Diabetes—a randomized, controlled trial. Ann Intern Med. 2005 Oct 18;143(8):549-588.
• The Pink Sheet, February 14, 2006; Volume 68, Number 7.Available at www.fda.gov/bbs/topics/news/2006/NEW01304.html. Last accessed March 8, 2006.

References—Levemir

• Levemir (insulin detemir [rDNA origin] injection) package insert. Novo Nordisk, Inc. Princeton, NJ; October 2005.
• Goldman JD, Lee KW. Insulin detemir—a new basal insulin analog. nn Pharmacother. 2005;39:502-507.
• Home P, Bartley P, Russell-Jones D, et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with Type 1 diabetes—a randomized clinical trial. Diabetes Care. 2004;27:1081-1087. Available at http://press.novonordisk-us.com/internal.aspx?rid=318. Last accessed March 1, 2006.

Two new insulin products were recently FDA-approved, Exubera (inhaled human insulin, Pfizer/Nektar) and Levemir (insulin detemir, Novo Nordisk). These new insulins are important to hospitalists because admitted patients may be receiving them, patients may ask about them, and other members of the healthcare team may have questions, as well.

Nektar Therapeutics has been developing noninvasive macromolecules for inhaled delivery systems for many years. To develop Exubera (their first FDA-approved product), they collaborated with Pfizer and Sanofi-Aventis. Other Nektar products are not as far along in the U.S. drug approval process.

Exubera (inhalation powder, insulin human) was FDA-approved on January 27, 2006, and is expected to be on pharmacy shelves in June or July of this year. Exubera was also recently approved in Europe but is not available there yet, either. Exubera is short-acting and was approved for use in Types 1 and 2 diabetes mellitus in conjunction with oral agents, or with a basal insulin for basal/bolus dosing.

Peak Exubera levels occur in ~49 minutes (range 30-90 minutes) compared with regular insulin with a peak in 105 minutes (range, 60-240 minutes). In an open-label, 12-week, randomized, controlled trial Exubera improved glycemic control when substituted for or added to oral combination therapy (n=309) in adult Type 2 diabetes patients. There was a small decrease in HbA1c of ~1.4% in the Exubera-treated monotherapy patients. When Exubera was combined with two oral agents (an insulin sensitizer and a secretagogue), the HbA1c decreased ~1.9%. Patients who used only oral agents had an insignificant decrease in HbA1c (0.2%).

Investigators offered Types 1 and 2 diabetics open-label use of inhaled insulin for up to four years. The patients have maintained long-term glycemic control.

The Exubera inhaler device weighs 4 ounces and is about the size of a closed eyeglass case. Carrying the device may be problematic for some because of its size. Common side effects include cough, shortness of breath, sore throat, dry mouth, and hypoglycemia. Exubera is not recommended for 1) patients who have recently quit smoking (within six months); 2) current smokers; 3) asthmatics; or 4) those with bronchitis or emphysema.

Because Exubera is a new product that has not been available in other countries, its long-term safety is unknown. Pfizer is, however, committed to long-term safety and efficacy studies. Monitoring parameters specific to Exubera include: 1) baseline pulmonary function tests (PFTs); and 2) follow-up PFTs every six-12 months until more is known about the drug’s pulmonary safety.

The Word on the Street

Exubera’s manufacturers will likely target this agent to the population that will provide them with the greatest market potential (largest profit). Likely candidates will be those with poorly controlled diabetes on >2 oral agents; these patients will likely need more than another oral agent to improve their glycemic control. Pfizer may choose to market Exubera against insulin sensitizers such as rosiglitazone or pioglitazone —especially when it comes to pharmacoeconomics because the ‘glitazones are not yet available generically and are thus higher cost items.

Ease of use for Exubera versus injected insulin may be the sole advantage for this new agent. Some say that if Exubera is used as a tool for diabetics to get insulin treatment earlier (versus injected insulin), diabetic complications may be minimized; however, medication compliance will play a large role. The medical literature is full of articles regarding non-compliance/non-adherence with asthma inhalers, including improper inhaler use and non-use of these devices. So unless inhaled insulin can significantly improve outcomes compared with the inexpensive injections and other available therapies (e.g., insulin sensitizers), its place on health-system formularies may be limited at best.

Another Inhaled Option

Novo Nordisk received initial FDA approval for its long-acting, basal insulin analog—insulin detemir—on June 17, 2005. Subsequent approval for use in the pediatric population came on October 20, 2005. Levemir is expected on U.S. pharmacy shelves any day. Levemir has been approved in 53 countries worldwide, and has been available in Europe since March 2004.

Levemir is a basal insulin, similar to Lantus (glargine, Sanofi-Aventis), and is approved for use in adults with Types 1 and 2 diabetes and in children with Type 1 diabetes.

It is recommended that Levemir be dosed once- or twice-daily subcutaneously. Pharmacokinetically Levemir has a relatively flat action profile with a mean duration of action ranging between 5.7–23.2 hours (data from clinical trials). Following subcutaneous administration, insulin detemir has a slower, more prolonged absorption over 24 hours compared with NPH insulin. Maximum serum concentrations occur within six to eight hours following administration.

A common side effect of insulin therapies is hypoglycemia. Other side effects common to human insulins include allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. A beneficial effect obtained in some of the Levemir clinical studies was weight loss (0.2 to 0.3-kg), which occurred in several Type 1 patients. Comparatively, the Type 1 patients who received NPH insulin noted weight gain (0.4 to 1.4-kg) over the six-12 month timeframe.

There are no specific monitoring parameters for insulin detemir, except for general management of the diabetic patient (e.g., fasting blood sugar, glycosylated hemoglobin, eye exam, podiatry).

At its launch, insulin detemir will be available in 10mL vials as well as in the Levemir FlexPen. The FlexPen will require the use of NovoFine 30- or 31-gauge disposable needles. TH

Michele Kaufman is based in New York City.

References—Exubera

• Hollander PA, Blonde L, Rowe R, et al. Efficacy and safety of inhaled insulin (Exubera) compared with subcutaneous insulin therapy in patients with Type 2 diabetes: Results of a 6-month, randomized, comparative trial. Diabetes Care. 2004;27:2356-2362.
• Skyler JS, Weinstock RS, Raskin P, et al. The Inhaled Insulin Phase III Type 1 Diabetes Study Group. Use of inhaled insulin in a basal/bolus insulin regimen in Type 1 diabetic subjects: a 6-month, randomized, comparative trial. Diabetes Care. 2005 Jul:28(7):1630-1635.
• Rosenstock J, Zinman B, Murphy LJ, et al. Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in Type 2 Diabetes—a randomized, controlled trial. Ann Intern Med. 2005 Oct 18;143(8):549-588.
• The Pink Sheet, February 14, 2006; Volume 68, Number 7.Available at www.fda.gov/bbs/topics/news/2006/NEW01304.html. Last accessed March 8, 2006.

References—Levemir

• Levemir (insulin detemir [rDNA origin] injection) package insert. Novo Nordisk, Inc. Princeton, NJ; October 2005.
• Goldman JD, Lee KW. Insulin detemir—a new basal insulin analog. nn Pharmacother. 2005;39:502-507.
• Home P, Bartley P, Russell-Jones D, et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with Type 1 diabetes—a randomized clinical trial. Diabetes Care. 2004;27:1081-1087. Available at http://press.novonordisk-us.com/internal.aspx?rid=318. Last accessed March 1, 2006.