Patrice Wendling

AUSTIN, TEX. — Most palliative care patients will suffer delirium at the end of life, yet the condition is often misdiagnosed and underrecognized.

The prevalence of delirium reaches 56% in hospitalized elderly patients, 87% in the ICU, and 88% in advanced cancer patients—and may be as high as 100% in patients receiving palliative care at death, palliative care pharmacist Rosene Pirrello said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Delirium develops quickly, may fluctuate throughout the day, and presents with a variety of symptoms, including inattention, confusion, agitation, delusions, lethargy, stupor, and coma.

The consequences of delirium can be significant, said Ms. Pirrello, of the Institute for Palliative Medicine at San Diego Hospice. The condition can increase mortality and morbidity, result in prolonged hospitalizations, and reduce quality of life. In 99 terminally ill cancer patients who recovered from delirium, 73 (74%) remembered the episode, and of those, 59 reported the experience as distressing (Cancer 2009 Feb. 24 [doi:10.1002/cncr.24215]). Caregivers and spouses reported similar levels of distress.

How often is delirium overlooked? In 107 patients with terminal cancer who had all experienced delirium, the overall detection rate was 47%; just 20.5% of the cases of hypoactive delirium, the most prevalent and underrecognized subtype, were detected (Jpn. J. Clin. Oncol. 2008;38:56–63), said psychiatrist Scott Irwin, director of psychiatry programs at the San Diego institute. In his own review of 2,716 hospice patients at the institute, delirium was documented in 18% of home care patients and in 28% of inpatients.

“This is grossly underrecognized, not only in our setting, but in all settings,” he said.

Delirium management should ensure patient safety, assess causes, and address environmental issues, Dr. Irwin said. Delirium has many causes, with medications at the top of the list. Environmental interventions can include providing materials that orient patients to the surroundings, adequate but soft lighting, and sensory aids; maintaining caregiver consistency; limiting stimulation; and having companions at the bedside for safety.

Treatment is radically different depending on the context and goals of care. “Benzodiazepines are the medication of choice for settling patients at the end of life, but they are completely contraindicated in our mind in the management of potentially reversible delirium,” said Dr. Frank Ferris, director of international programs at the institute.

Because of the neurologic and physiologic changes that occur when a patient is dying, it is probably impossible to do anything more than settle an agitated patient, he said.

“How many of you have had patients and families say to you in the agitation and confusion of dying, 'Please, simply settle the patient; we can't stand to watch it'?” Dr. Ferris asked his audience.

Benzodiazepines such as lorazepam and midazolam are sedatives that can decrease agitation and relax skeletal muscles. But more important, they are amnesics, Dr. Ferris said.

“If you actually ask patients who are approaching the end of their lives—and I do this with virtually everybody—'If you get to a place where you are agitated and confused, do you want to experience that or not?' virtually everyone says, 'I don't want to experience it or remember it,' ” he said.

Neuroleptics are a better choice for potentially reversible delirium, in part because they may not cause sedation to the same degree that benzodiazepines do, they are not amnesics, and they may decrease the seizure threshold. Evidence suggests that older neuroleptics such as haloperidol are as safe and effective as newer agents, and they are cheaper and have more routes of administration.

All of the speakers stressed that delirium is not the same as dementia, although the two are often confused. Cognitive impairment is present in both, but rapid onset is unique to delirium. The differential diagnosis for delirium also includes depression, anxiety, and akathisia, Dr. Irwin said.

Tools that can help improve delirium recognition include the Confusion Assessment Method, which asks four simple questions and has a robust sensitivity of 94%–100% and specificity of 90%–95%, Dr. Irwin said.

Etiology is important because delirium is reversible in about 50% of cases, Ms. Pirrello said. An acronym that can bring to mind the many causes of delirium is I WATCH DEATH O, she said. The letters stand for Infection, Withdrawal, Acute metabolic changes, Trauma, CNS pathology, Hypoxia, Deficiencies, Endocrinopathies, Acute vascular events, Toxins or drugs, Heavy metals, and Other.

The speakers reported no relevant conflicts of interest.

AUSTIN, TEX. — Most palliative care patients will suffer delirium at the end of life, yet the condition is often misdiagnosed and underrecognized.

The prevalence of delirium reaches 56% in hospitalized elderly patients, 87% in the ICU, and 88% in advanced cancer patients—and may be as high as 100% in patients receiving palliative care at death, palliative care pharmacist Rosene Pirrello said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Delirium develops quickly, may fluctuate throughout the day, and presents with a variety of symptoms, including inattention, confusion, agitation, delusions, lethargy, stupor, and coma.

The consequences of delirium can be significant, said Ms. Pirrello, of the Institute for Palliative Medicine at San Diego Hospice. The condition can increase mortality and morbidity, result in prolonged hospitalizations, and reduce quality of life. In 99 terminally ill cancer patients who recovered from delirium, 73 (74%) remembered the episode, and of those, 59 reported the experience as distressing (Cancer 2009 Feb. 24 [doi:10.1002/cncr.24215]). Caregivers and spouses reported similar levels of distress.

How often is delirium overlooked? In 107 patients with terminal cancer who had all experienced delirium, the overall detection rate was 47%; just 20.5% of the cases of hypoactive delirium, the most prevalent and underrecognized subtype, were detected (Jpn. J. Clin. Oncol. 2008;38:56–63), said psychiatrist Scott Irwin, director of psychiatry programs at the San Diego institute. In his own review of 2,716 hospice patients at the institute, delirium was documented in 18% of home care patients and in 28% of inpatients.

“This is grossly underrecognized, not only in our setting, but in all settings,” he said.

Delirium management should ensure patient safety, assess causes, and address environmental issues, Dr. Irwin said. Delirium has many causes, with medications at the top of the list. Environmental interventions can include providing materials that orient patients to the surroundings, adequate but soft lighting, and sensory aids; maintaining caregiver consistency; limiting stimulation; and having companions at the bedside for safety.

Treatment is radically different depending on the context and goals of care. “Benzodiazepines are the medication of choice for settling patients at the end of life, but they are completely contraindicated in our mind in the management of potentially reversible delirium,” said Dr. Frank Ferris, director of international programs at the institute.

Because of the neurologic and physiologic changes that occur when a patient is dying, it is probably impossible to do anything more than settle an agitated patient, he said.

“How many of you have had patients and families say to you in the agitation and confusion of dying, 'Please, simply settle the patient; we can't stand to watch it'?” Dr. Ferris asked his audience.

Benzodiazepines such as lorazepam and midazolam are sedatives that can decrease agitation and relax skeletal muscles. But more important, they are amnesics, Dr. Ferris said.

“If you actually ask patients who are approaching the end of their lives—and I do this with virtually everybody—'If you get to a place where you are agitated and confused, do you want to experience that or not?' virtually everyone says, 'I don't want to experience it or remember it,' ” he said.

Neuroleptics are a better choice for potentially reversible delirium, in part because they may not cause sedation to the same degree that benzodiazepines do, they are not amnesics, and they may decrease the seizure threshold. Evidence suggests that older neuroleptics such as haloperidol are as safe and effective as newer agents, and they are cheaper and have more routes of administration.

All of the speakers stressed that delirium is not the same as dementia, although the two are often confused. Cognitive impairment is present in both, but rapid onset is unique to delirium. The differential diagnosis for delirium also includes depression, anxiety, and akathisia, Dr. Irwin said.

Tools that can help improve delirium recognition include the Confusion Assessment Method, which asks four simple questions and has a robust sensitivity of 94%–100% and specificity of 90%–95%, Dr. Irwin said.

Etiology is important because delirium is reversible in about 50% of cases, Ms. Pirrello said. An acronym that can bring to mind the many causes of delirium is I WATCH DEATH O, she said. The letters stand for Infection, Withdrawal, Acute metabolic changes, Trauma, CNS pathology, Hypoxia, Deficiencies, Endocrinopathies, Acute vascular events, Toxins or drugs, Heavy metals, and Other.

The speakers reported no relevant conflicts of interest.

AUSTIN, TEX. — Most palliative care patients will suffer delirium at the end of life, yet the condition is often misdiagnosed and underrecognized.

The prevalence of delirium reaches 56% in hospitalized elderly patients, 87% in the ICU, and 88% in advanced cancer patients—and may be as high as 100% in patients receiving palliative care at death, palliative care pharmacist Rosene Pirrello said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

Delirium develops quickly, may fluctuate throughout the day, and presents with a variety of symptoms, including inattention, confusion, agitation, delusions, lethargy, stupor, and coma.

The consequences of delirium can be significant, said Ms. Pirrello, of the Institute for Palliative Medicine at San Diego Hospice. The condition can increase mortality and morbidity, result in prolonged hospitalizations, and reduce quality of life. In 99 terminally ill cancer patients who recovered from delirium, 73 (74%) remembered the episode, and of those, 59 reported the experience as distressing (Cancer 2009 Feb. 24 [doi:10.1002/cncr.24215]). Caregivers and spouses reported similar levels of distress.

How often is delirium overlooked? In 107 patients with terminal cancer who had all experienced delirium, the overall detection rate was 47%; just 20.5% of the cases of hypoactive delirium, the most prevalent and underrecognized subtype, were detected (Jpn. J. Clin. Oncol. 2008;38:56–63), said psychiatrist Scott Irwin, director of psychiatry programs at the San Diego institute. In his own review of 2,716 hospice patients at the institute, delirium was documented in 18% of home care patients and in 28% of inpatients.

“This is grossly underrecognized, not only in our setting, but in all settings,” he said.

Delirium management should ensure patient safety, assess causes, and address environmental issues, Dr. Irwin said. Delirium has many causes, with medications at the top of the list. Environmental interventions can include providing materials that orient patients to the surroundings, adequate but soft lighting, and sensory aids; maintaining caregiver consistency; limiting stimulation; and having companions at the bedside for safety.

Treatment is radically different depending on the context and goals of care. “Benzodiazepines are the medication of choice for settling patients at the end of life, but they are completely contraindicated in our mind in the management of potentially reversible delirium,” said Dr. Frank Ferris, director of international programs at the institute.

Because of the neurologic and physiologic changes that occur when a patient is dying, it is probably impossible to do anything more than settle an agitated patient, he said.

“How many of you have had patients and families say to you in the agitation and confusion of dying, 'Please, simply settle the patient; we can't stand to watch it'?” Dr. Ferris asked his audience.

Benzodiazepines such as lorazepam and midazolam are sedatives that can decrease agitation and relax skeletal muscles. But more important, they are amnesics, Dr. Ferris said.

“If you actually ask patients who are approaching the end of their lives—and I do this with virtually everybody—'If you get to a place where you are agitated and confused, do you want to experience that or not?' virtually everyone says, 'I don't want to experience it or remember it,' ” he said.

Neuroleptics are a better choice for potentially reversible delirium, in part because they may not cause sedation to the same degree that benzodiazepines do, they are not amnesics, and they may decrease the seizure threshold. Evidence suggests that older neuroleptics such as haloperidol are as safe and effective as newer agents, and they are cheaper and have more routes of administration.

All of the speakers stressed that delirium is not the same as dementia, although the two are often confused. Cognitive impairment is present in both, but rapid onset is unique to delirium. The differential diagnosis for delirium also includes depression, anxiety, and akathisia, Dr. Irwin said.

Tools that can help improve delirium recognition include the Confusion Assessment Method, which asks four simple questions and has a robust sensitivity of 94%–100% and specificity of 90%–95%, Dr. Irwin said.

Etiology is important because delirium is reversible in about 50% of cases, Ms. Pirrello said. An acronym that can bring to mind the many causes of delirium is I WATCH DEATH O, she said. The letters stand for Infection, Withdrawal, Acute metabolic changes, Trauma, CNS pathology, Hypoxia, Deficiencies, Endocrinopathies, Acute vascular events, Toxins or drugs, Heavy metals, and Other.

The speakers reported no relevant conflicts of interest.

ORLANDO — Estrogen patches produce a similar fall in testosterone and prostate-specific antigen levels when compared with luteinizing hormone-releasing hormone analogues in locally advanced and metastatic prostate cancer, according to interim results from the phase II, multicenter PATCH trial.

Intention-to-treat data from the first 100 patients show that castration was achieved at 4 weeks in 67% of 30 men who started treatment with three patches that were changed twice weekly. This increased to 91% of 33 men who started with four patches changed twice weekly. In comparison, 64% of 33 men who were treated with LHRH analogues achieved castration by that time point.

At 12 weeks, castration rates were 72%, 87%, and 93%, respectively, coauthors Dr. Ruth Langley and Dr. Paul Abel reported in a poster at a symposium on genitourinary cancers. Castration was defined as a testosterone level of 50 ng/dL or less.

PSA responses were observed in all three groups at 6 months. Levels fell from a baseline median of 51 ng/mL in both patch groups to 1.3 ng/mL with four patches changed twice weekly and 3.2 ng/mL with three patches changed twice weekly. They went from a median of 35 ng/mL at baseline to 0.9 ng/mL at 6 months in the control group.

“Providing [that these data] continue to look promising, we are aiming to extend this to a phase III study,” Dr. Langley of the U.K. Medical Research Council Clinical Trials Unit said in an interview.

The hypothesis behind the PATCH (Prostate Adenocarcinoma: Transcutaneous Hormones) trial is that the application of estrogen to the skin will avoid first-pass hepatic metabolism (that is, the hepatic metabolism of a drug when it is absorbed from the gut and delivered to the liver via the portal vein), and therefore will not be associated with the same cardiovascular toxicity previously shown by oral estrogen.

Prolonged use of LHRH analogues has also raised concerns about long-term toxicity, particularly osteoporosis and metabolic syndrome.

Estrogen has been shown in previous studies to protect against bone mineral density loss in women, and pilot data from a study in 20 men with prostate cancer show that transdermal estrogen improved bone density at 1 year (J. Urol. 2004;172:2203-7).

“The mechanism underlying this is not clear, but it has been postulated that androgens are converted by aromatase to estradiol in bone, and thus some of the protective effects of androgens on bone are mediated through local production of estrogen,” Dr. Langley said.

As of mid-February 2009, 172 men had been randomized to three arms: three estrogen patches changed twice weekly for 4 weeks, followed by two patches changed twice weekly for an indefinite time; four patches changed twice weekly for 4 weeks, followed by three patches changed indefinitely; or a control arm of LHRH analogues, as per local practice. The primary end point is cardiovascular mortality and morbidity.

A Gleason score greater than 7 was reported in 44% of control patients and in 49% of patch patients. Their median age was 75 years and 73 years, respectively.

Four patients have stopped using patches because they were falling off, and two stopped by choice.

Noncardiovascular toxicity has been as expected, and includes gynecomastia and some erythema, the authors reported at the meeting, which was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology. One patient developed erythema nodosum, which started approximately 4 weeks after the patches were placed, and resolved when they were discontinued.

The PATCH trial is sponsored by the Imperial College London and funded by Cancer Research U.K. Dr. Abel, of Imperial College London, disclosed consultancy with Ascend Pharmaceuticals, which makes an estrogen gel.

ORLANDO — Estrogen patches produce a similar fall in testosterone and prostate-specific antigen levels when compared with luteinizing hormone-releasing hormone analogues in locally advanced and metastatic prostate cancer, according to interim results from the phase II, multicenter PATCH trial.

Intention-to-treat data from the first 100 patients show that castration was achieved at 4 weeks in 67% of 30 men who started treatment with three patches that were changed twice weekly. This increased to 91% of 33 men who started with four patches changed twice weekly. In comparison, 64% of 33 men who were treated with LHRH analogues achieved castration by that time point.

At 12 weeks, castration rates were 72%, 87%, and 93%, respectively, coauthors Dr. Ruth Langley and Dr. Paul Abel reported in a poster at a symposium on genitourinary cancers. Castration was defined as a testosterone level of 50 ng/dL or less.

PSA responses were observed in all three groups at 6 months. Levels fell from a baseline median of 51 ng/mL in both patch groups to 1.3 ng/mL with four patches changed twice weekly and 3.2 ng/mL with three patches changed twice weekly. They went from a median of 35 ng/mL at baseline to 0.9 ng/mL at 6 months in the control group.

“Providing [that these data] continue to look promising, we are aiming to extend this to a phase III study,” Dr. Langley of the U.K. Medical Research Council Clinical Trials Unit said in an interview.

The hypothesis behind the PATCH (Prostate Adenocarcinoma: Transcutaneous Hormones) trial is that the application of estrogen to the skin will avoid first-pass hepatic metabolism (that is, the hepatic metabolism of a drug when it is absorbed from the gut and delivered to the liver via the portal vein), and therefore will not be associated with the same cardiovascular toxicity previously shown by oral estrogen.

Prolonged use of LHRH analogues has also raised concerns about long-term toxicity, particularly osteoporosis and metabolic syndrome.

Estrogen has been shown in previous studies to protect against bone mineral density loss in women, and pilot data from a study in 20 men with prostate cancer show that transdermal estrogen improved bone density at 1 year (J. Urol. 2004;172:2203-7).

“The mechanism underlying this is not clear, but it has been postulated that androgens are converted by aromatase to estradiol in bone, and thus some of the protective effects of androgens on bone are mediated through local production of estrogen,” Dr. Langley said.

As of mid-February 2009, 172 men had been randomized to three arms: three estrogen patches changed twice weekly for 4 weeks, followed by two patches changed twice weekly for an indefinite time; four patches changed twice weekly for 4 weeks, followed by three patches changed indefinitely; or a control arm of LHRH analogues, as per local practice. The primary end point is cardiovascular mortality and morbidity.

A Gleason score greater than 7 was reported in 44% of control patients and in 49% of patch patients. Their median age was 75 years and 73 years, respectively.

Four patients have stopped using patches because they were falling off, and two stopped by choice.

Noncardiovascular toxicity has been as expected, and includes gynecomastia and some erythema, the authors reported at the meeting, which was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology. One patient developed erythema nodosum, which started approximately 4 weeks after the patches were placed, and resolved when they were discontinued.

The PATCH trial is sponsored by the Imperial College London and funded by Cancer Research U.K. Dr. Abel, of Imperial College London, disclosed consultancy with Ascend Pharmaceuticals, which makes an estrogen gel.

ORLANDO — Estrogen patches produce a similar fall in testosterone and prostate-specific antigen levels when compared with luteinizing hormone-releasing hormone analogues in locally advanced and metastatic prostate cancer, according to interim results from the phase II, multicenter PATCH trial.

Intention-to-treat data from the first 100 patients show that castration was achieved at 4 weeks in 67% of 30 men who started treatment with three patches that were changed twice weekly. This increased to 91% of 33 men who started with four patches changed twice weekly. In comparison, 64% of 33 men who were treated with LHRH analogues achieved castration by that time point.

At 12 weeks, castration rates were 72%, 87%, and 93%, respectively, coauthors Dr. Ruth Langley and Dr. Paul Abel reported in a poster at a symposium on genitourinary cancers. Castration was defined as a testosterone level of 50 ng/dL or less.

PSA responses were observed in all three groups at 6 months. Levels fell from a baseline median of 51 ng/mL in both patch groups to 1.3 ng/mL with four patches changed twice weekly and 3.2 ng/mL with three patches changed twice weekly. They went from a median of 35 ng/mL at baseline to 0.9 ng/mL at 6 months in the control group.

“Providing [that these data] continue to look promising, we are aiming to extend this to a phase III study,” Dr. Langley of the U.K. Medical Research Council Clinical Trials Unit said in an interview.

The hypothesis behind the PATCH (Prostate Adenocarcinoma: Transcutaneous Hormones) trial is that the application of estrogen to the skin will avoid first-pass hepatic metabolism (that is, the hepatic metabolism of a drug when it is absorbed from the gut and delivered to the liver via the portal vein), and therefore will not be associated with the same cardiovascular toxicity previously shown by oral estrogen.

Prolonged use of LHRH analogues has also raised concerns about long-term toxicity, particularly osteoporosis and metabolic syndrome.

Estrogen has been shown in previous studies to protect against bone mineral density loss in women, and pilot data from a study in 20 men with prostate cancer show that transdermal estrogen improved bone density at 1 year (J. Urol. 2004;172:2203-7).

“The mechanism underlying this is not clear, but it has been postulated that androgens are converted by aromatase to estradiol in bone, and thus some of the protective effects of androgens on bone are mediated through local production of estrogen,” Dr. Langley said.

As of mid-February 2009, 172 men had been randomized to three arms: three estrogen patches changed twice weekly for 4 weeks, followed by two patches changed twice weekly for an indefinite time; four patches changed twice weekly for 4 weeks, followed by three patches changed indefinitely; or a control arm of LHRH analogues, as per local practice. The primary end point is cardiovascular mortality and morbidity.

A Gleason score greater than 7 was reported in 44% of control patients and in 49% of patch patients. Their median age was 75 years and 73 years, respectively.

Four patients have stopped using patches because they were falling off, and two stopped by choice.

Noncardiovascular toxicity has been as expected, and includes gynecomastia and some erythema, the authors reported at the meeting, which was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology. One patient developed erythema nodosum, which started approximately 4 weeks after the patches were placed, and resolved when they were discontinued.

The PATCH trial is sponsored by the Imperial College London and funded by Cancer Research U.K. Dr. Abel, of Imperial College London, disclosed consultancy with Ascend Pharmaceuticals, which makes an estrogen gel.

Mistrust of the health care system was linked to lower use of breast cancer screening among black, Hispanic, and Arab American women, in a prospective study of 341 patients from these ethnic groups.

Using the previously validated seven-item Medical Mistrust Index, community health workers found that more than 40% of the women in these three racial-ethnic groups agreed or strongly agreed with all of the mistrust statements in the index.

For example, 49% of surveyed women agreed with the statement that “Patients have sometimes been deceived or misled by health care organizations.”

Black, Hispanic, and Arab American women with higher levels of mistrust were less likely to adhere to appropriately timed breast cancer screening, Dr. Karen Patricia Williams and her associates reported at the American Association for Cancer Research conference on the science of cancer health disparities.

Overall, 44% of these women who had never had a clinical breast exam agreed with the statement that “Health care organizations have sometimes done harmful experiments on patients without their knowledge,” compared with 38% of women who had ever received a clinical breast exam. The difference between groups was significant.

Significantly more women who had not received a clinical breast exam in the previous 12 months (49%) also agreed with this same statement, compared with women who had had a breast exam in the previous 12 months (33%), the investigators reported.

In addition, 64% of women who had no history of an exam in the previous 12 months agreed with the statement “Sometimes I wonder if health care organizations really know what they are doing,” compared with 47% of those who had received an exam in the past year—a significant difference.

“Typically, what we have done is intellectualize the problem; that the problem is that blacks have a memory of the Tuskegee Experiment,” Dr. Williams said in an interview. “But this shows that medical mistrust goes beyond Tuskegee to where we are today in 2009,” and that it's not just blacks, but also Arabs and Hispanics.

“That says something about the system and that we need to work on the system itself,” she said.

Black women were found to have the highest level of medical mistrust.

More than one-third (39%) of black women strongly agreed with the statement that “Health care organizations don't always keep your information totally private,” compared with 15% of Hispanic women and 9% of Arab American.

Hispanic and Arab American women may have demonstrated less distrust because many were newly immigrated and may have had limited experience with the health care system, according to Dr. Williams of the departments of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

The Medical Mistrust Index was orally administered by community health workers in English, Spanish, or Arabic to 116 black women, 113 Hispanic women, and 112 Arab American women.

Their median age was 44 years (range 21–87 years). Annual income was $40,000 or more for 14% of black women and 8% of Hispanic and Arab women.

Insurance was in place for 94% of blacks, 45% of Hispanics, and 43% of Arabs.

During a press conference at the meeting, Dr. Williams acknowledged that insurance coverage plays a large role in the use of cancer screenings but said that the role of medical mistrust cannot be ignored.

She urged health care organizations to tailor prevention interventions to individual ethnic groups, rather than adopting a “one size fits all” approach.

All of the women in the study were marginalized, she said, citing racial discrimination for blacks, immigration concerns for Hispanics, and anger toward Arabs over Sept. 11.

When asked specifically how this played out in the patient-physician interaction, Dr. Williams said they had only anecdotal information and it was directed at the health care system as a whole.

She also noted that women in the study used various health care systems in southeast Michigan, suggesting that mistrust is not with one problematic clinic, but rather is systemwide.

“Our medical systems in general have some work to do to build trust with racial [minorities] and ethnic women,” she said.

It is unclear how the level of medical mistrust observed in these three ethnic groups compares with mistrust among whites, Dr. Williams said.

The next step is to study the issue in a larger, national population as it relates to the use of breast and cervical screening and other medical services.

The study was funded by Susan G. Komen for the Cure.

The investigators reported no conflicts of interest.

Mistrust of the health care system was linked to lower use of breast cancer screening among black, Hispanic, and Arab American women, in a prospective study of 341 patients from these ethnic groups.

Using the previously validated seven-item Medical Mistrust Index, community health workers found that more than 40% of the women in these three racial-ethnic groups agreed or strongly agreed with all of the mistrust statements in the index.

For example, 49% of surveyed women agreed with the statement that “Patients have sometimes been deceived or misled by health care organizations.”

Black, Hispanic, and Arab American women with higher levels of mistrust were less likely to adhere to appropriately timed breast cancer screening, Dr. Karen Patricia Williams and her associates reported at the American Association for Cancer Research conference on the science of cancer health disparities.

Overall, 44% of these women who had never had a clinical breast exam agreed with the statement that “Health care organizations have sometimes done harmful experiments on patients without their knowledge,” compared with 38% of women who had ever received a clinical breast exam. The difference between groups was significant.

Significantly more women who had not received a clinical breast exam in the previous 12 months (49%) also agreed with this same statement, compared with women who had had a breast exam in the previous 12 months (33%), the investigators reported.

In addition, 64% of women who had no history of an exam in the previous 12 months agreed with the statement “Sometimes I wonder if health care organizations really know what they are doing,” compared with 47% of those who had received an exam in the past year—a significant difference.

“Typically, what we have done is intellectualize the problem; that the problem is that blacks have a memory of the Tuskegee Experiment,” Dr. Williams said in an interview. “But this shows that medical mistrust goes beyond Tuskegee to where we are today in 2009,” and that it's not just blacks, but also Arabs and Hispanics.

“That says something about the system and that we need to work on the system itself,” she said.

Black women were found to have the highest level of medical mistrust.

More than one-third (39%) of black women strongly agreed with the statement that “Health care organizations don't always keep your information totally private,” compared with 15% of Hispanic women and 9% of Arab American.

Hispanic and Arab American women may have demonstrated less distrust because many were newly immigrated and may have had limited experience with the health care system, according to Dr. Williams of the departments of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

The Medical Mistrust Index was orally administered by community health workers in English, Spanish, or Arabic to 116 black women, 113 Hispanic women, and 112 Arab American women.

Their median age was 44 years (range 21–87 years). Annual income was $40,000 or more for 14% of black women and 8% of Hispanic and Arab women.

Insurance was in place for 94% of blacks, 45% of Hispanics, and 43% of Arabs.

During a press conference at the meeting, Dr. Williams acknowledged that insurance coverage plays a large role in the use of cancer screenings but said that the role of medical mistrust cannot be ignored.

She urged health care organizations to tailor prevention interventions to individual ethnic groups, rather than adopting a “one size fits all” approach.

All of the women in the study were marginalized, she said, citing racial discrimination for blacks, immigration concerns for Hispanics, and anger toward Arabs over Sept. 11.

When asked specifically how this played out in the patient-physician interaction, Dr. Williams said they had only anecdotal information and it was directed at the health care system as a whole.

She also noted that women in the study used various health care systems in southeast Michigan, suggesting that mistrust is not with one problematic clinic, but rather is systemwide.

“Our medical systems in general have some work to do to build trust with racial [minorities] and ethnic women,” she said.

It is unclear how the level of medical mistrust observed in these three ethnic groups compares with mistrust among whites, Dr. Williams said.

The next step is to study the issue in a larger, national population as it relates to the use of breast and cervical screening and other medical services.

The study was funded by Susan G. Komen for the Cure.

The investigators reported no conflicts of interest.

Mistrust of the health care system was linked to lower use of breast cancer screening among black, Hispanic, and Arab American women, in a prospective study of 341 patients from these ethnic groups.

Using the previously validated seven-item Medical Mistrust Index, community health workers found that more than 40% of the women in these three racial-ethnic groups agreed or strongly agreed with all of the mistrust statements in the index.

For example, 49% of surveyed women agreed with the statement that “Patients have sometimes been deceived or misled by health care organizations.”

Black, Hispanic, and Arab American women with higher levels of mistrust were less likely to adhere to appropriately timed breast cancer screening, Dr. Karen Patricia Williams and her associates reported at the American Association for Cancer Research conference on the science of cancer health disparities.

Overall, 44% of these women who had never had a clinical breast exam agreed with the statement that “Health care organizations have sometimes done harmful experiments on patients without their knowledge,” compared with 38% of women who had ever received a clinical breast exam. The difference between groups was significant.

Significantly more women who had not received a clinical breast exam in the previous 12 months (49%) also agreed with this same statement, compared with women who had had a breast exam in the previous 12 months (33%), the investigators reported.

In addition, 64% of women who had no history of an exam in the previous 12 months agreed with the statement “Sometimes I wonder if health care organizations really know what they are doing,” compared with 47% of those who had received an exam in the past year—a significant difference.

“Typically, what we have done is intellectualize the problem; that the problem is that blacks have a memory of the Tuskegee Experiment,” Dr. Williams said in an interview. “But this shows that medical mistrust goes beyond Tuskegee to where we are today in 2009,” and that it's not just blacks, but also Arabs and Hispanics.

“That says something about the system and that we need to work on the system itself,” she said.

Black women were found to have the highest level of medical mistrust.

More than one-third (39%) of black women strongly agreed with the statement that “Health care organizations don't always keep your information totally private,” compared with 15% of Hispanic women and 9% of Arab American.

Hispanic and Arab American women may have demonstrated less distrust because many were newly immigrated and may have had limited experience with the health care system, according to Dr. Williams of the departments of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

The Medical Mistrust Index was orally administered by community health workers in English, Spanish, or Arabic to 116 black women, 113 Hispanic women, and 112 Arab American women.

Their median age was 44 years (range 21–87 years). Annual income was $40,000 or more for 14% of black women and 8% of Hispanic and Arab women.

Insurance was in place for 94% of blacks, 45% of Hispanics, and 43% of Arabs.

During a press conference at the meeting, Dr. Williams acknowledged that insurance coverage plays a large role in the use of cancer screenings but said that the role of medical mistrust cannot be ignored.

She urged health care organizations to tailor prevention interventions to individual ethnic groups, rather than adopting a “one size fits all” approach.

All of the women in the study were marginalized, she said, citing racial discrimination for blacks, immigration concerns for Hispanics, and anger toward Arabs over Sept. 11.

When asked specifically how this played out in the patient-physician interaction, Dr. Williams said they had only anecdotal information and it was directed at the health care system as a whole.

She also noted that women in the study used various health care systems in southeast Michigan, suggesting that mistrust is not with one problematic clinic, but rather is systemwide.

“Our medical systems in general have some work to do to build trust with racial [minorities] and ethnic women,” she said.

It is unclear how the level of medical mistrust observed in these three ethnic groups compares with mistrust among whites, Dr. Williams said.

The next step is to study the issue in a larger, national population as it relates to the use of breast and cervical screening and other medical services.

The study was funded by Susan G. Komen for the Cure.

The investigators reported no conflicts of interest.

CHICAGO — Clinicians need to step up their use of vaccinations as part of an overall plan to reduce the risk of infection in patients with rheumatic disease who receive tumor necrosis factor inhibitors, Dr. John J. Cush said at a symposium sponsored by the American College of Rheumatology.

“We are not as good as we should be [about vaccinations], and they can really have a big impact by preventing serious infections, especially in our immunosuppressed patients,” he said.

Data from pivotal trials show that the risk of serious infectious events with the biologics is two times that with placebo. This trend did not reach statistical significance in many of the studies, but in the real world it becomes significant, said Dr. Cush, director of clinical rheumatology for the Baylor Research Institute and a professor of medicine and rheumatology at Baylor College of Medicine in Dallas.

He suggests that patients with rheumatoid arthritis (RA) should receive the yearly influenza vaccine, and that pneumococcal vaccinations should be given once, with a second dose 5 years later.

Vaccines for meningococcal disease, human papillomavirus, and hepatitis B are needed where exposure is likely, but it is important to avoid live attenuated vaccines.

The package inserts for several TNF inhibitors were also revised in 2007-2008, warning that tuberculosis has been observed with their use. Data from the British Society for Rheumatology Biologics Register on 10,403 patients taking anti-TNF agents and 3,106 patients taking only disease-modifying anti-rheumatic drugs identified 35 cases of tuberculosis, all occurring in patients on anti-TNF agents. The TB rate was 110 per 100,000 patient-years in anti-TNF-treated patients, putting them above the rate for the general U.K. and U.S. populations (6 per 100,000 patient-years) and on par with alcoholics and patients with HIV, Dr. Cush said.

Manufacturers of anti-TNF agents advise clinicians to employ tuberculosis skin testing (purified protein derivative tuberculin) prior to initiating therapy; to monitor for signs and symptoms of TB, even if the initial PPD was negative; and to initiate latent tuberculosis infection (LTBI) treatment prior to TNF therapy.

Dr. Cush suggested that patients with a positive skin test (5 mm or more) or a history of LTBI can be treated with TNF inhibitors immediately after TB therapy with isoniazid is initiated. Moreover, this practice is routine in some RA clinical trials.

Arguments for suspending anti-TNF therapy could include the belief that TB treatment confers protection, or that anti-TNF therapy may increase the potential for toxicity or may cause worsening of latent TB infection before treatment with isoniazid can start working. Dr. Cush contends that there are no data to support waiting, and although toxicity may be an issue, it can be identified early on by lab testing and physician observation. Reactivation of LTBI has not been shown to occur in anti-TNF-treated patients.

To drive home his point, Dr. Cush highlighted a study among Africans with HIV-associated TB in which eight doses of etanercept (25 mg) administered twice weekly beginning on day 4 of TB therapy actually improved TB killing and overall responses, compared with control therapy (AIDS 2004;18:257-64).

Dr. Cush acknowledged that he would not use TNF inhibitors in RA patients who have invasive fungal disease or chronic hepatitis B, or in those infected with atypical mycobacteria. Clinicians should have safeguards and reminders in place to do PPD skin tests in all RA patients prior to TNF-inhibitor therapy and during year 2 (or when TNF-inhibitor therapy is changed), as this will occasionally pick up patients with latent TB who were initially anergic, he said.

There is no added yield to further annual testing, but the PPD skin test can be repeated if the patient has had a recent exposure, has traveled to a high-risk or endemic area, or has signs or symptoms of a mycobacterial infection.

PPD results are notoriously variable depending on who conducts the test, but results are good for 1-2 weeks, Dr. Cush said.

“It's better to have a patient come back late than not at all,” he said. “The best PPD is the one done by you and read by you.”

As an alternative—or in addition—to conventional skin tests, clinicians may want to consider using the QuantiFERON TB test, which was approved by the Food and Drug Administration in 2001 and measures the release of interferon-gamma in whole blood in response to stimulation by a purified protein derivative. Roughly 10% of QuantiFERON testing is indeterminate, but in general, clinicians can “hang their hat on the results,” he said, noting that PPD tests may be positive in those with a history of bacille Calmette-Guérin (BCG) vaccination, whereas QuantiFERON is unaffected by BCG and more truly reflects the likelihood of latent TB infection.

There is no evidence to support the practice of suspending TNF-inhibitor use in the setting of nonserious infections, unless the symptoms or signs are suggestive of a more serious infection, Dr. Cush said.

In a meta-analysis to be presented by colleague Dr. Kathryn Dao at the upcoming European League Against Rheumatism meeting in Copenhagen, the risk for nonserious infections was increased in patients with RA who received adalimumab (odds ratio, 1.39) or infliximab (OR, 1.53), but not etanercept (OR, 0.99).

“The magnitude is small, but we have to be mindful of these very common events and how they can be properly managed in patients receiving biologics,” he said.

Dr. Cush disclosed that he has been an adviser, consultant, or lecturer for Abbott Laboratories, Centocor Inc., Pfizer Inc., Roche, UCB SA, and Wyeth.

He noted he has been a clinical investigator for or received research support from Celgene Corp., Genentech Inc., Pfizer, Roche, UCB, and the Consortium of Rheumatology Researchers of North America.

While patients need flu shots and other regular immunizations, attenuated vaccines should be avoided. DR. CUSH

CHICAGO — Clinicians need to step up their use of vaccinations as part of an overall plan to reduce the risk of infection in patients with rheumatic disease who receive tumor necrosis factor inhibitors, Dr. John J. Cush said at a symposium sponsored by the American College of Rheumatology.

“We are not as good as we should be [about vaccinations], and they can really have a big impact by preventing serious infections, especially in our immunosuppressed patients,” he said.

Data from pivotal trials show that the risk of serious infectious events with the biologics is two times that with placebo. This trend did not reach statistical significance in many of the studies, but in the real world it becomes significant, said Dr. Cush, director of clinical rheumatology for the Baylor Research Institute and a professor of medicine and rheumatology at Baylor College of Medicine in Dallas.

He suggests that patients with rheumatoid arthritis (RA) should receive the yearly influenza vaccine, and that pneumococcal vaccinations should be given once, with a second dose 5 years later.

Vaccines for meningococcal disease, human papillomavirus, and hepatitis B are needed where exposure is likely, but it is important to avoid live attenuated vaccines.

The package inserts for several TNF inhibitors were also revised in 2007-2008, warning that tuberculosis has been observed with their use. Data from the British Society for Rheumatology Biologics Register on 10,403 patients taking anti-TNF agents and 3,106 patients taking only disease-modifying anti-rheumatic drugs identified 35 cases of tuberculosis, all occurring in patients on anti-TNF agents. The TB rate was 110 per 100,000 patient-years in anti-TNF-treated patients, putting them above the rate for the general U.K. and U.S. populations (6 per 100,000 patient-years) and on par with alcoholics and patients with HIV, Dr. Cush said.

Manufacturers of anti-TNF agents advise clinicians to employ tuberculosis skin testing (purified protein derivative tuberculin) prior to initiating therapy; to monitor for signs and symptoms of TB, even if the initial PPD was negative; and to initiate latent tuberculosis infection (LTBI) treatment prior to TNF therapy.

Dr. Cush suggested that patients with a positive skin test (5 mm or more) or a history of LTBI can be treated with TNF inhibitors immediately after TB therapy with isoniazid is initiated. Moreover, this practice is routine in some RA clinical trials.

Arguments for suspending anti-TNF therapy could include the belief that TB treatment confers protection, or that anti-TNF therapy may increase the potential for toxicity or may cause worsening of latent TB infection before treatment with isoniazid can start working. Dr. Cush contends that there are no data to support waiting, and although toxicity may be an issue, it can be identified early on by lab testing and physician observation. Reactivation of LTBI has not been shown to occur in anti-TNF-treated patients.

To drive home his point, Dr. Cush highlighted a study among Africans with HIV-associated TB in which eight doses of etanercept (25 mg) administered twice weekly beginning on day 4 of TB therapy actually improved TB killing and overall responses, compared with control therapy (AIDS 2004;18:257-64).

Dr. Cush acknowledged that he would not use TNF inhibitors in RA patients who have invasive fungal disease or chronic hepatitis B, or in those infected with atypical mycobacteria. Clinicians should have safeguards and reminders in place to do PPD skin tests in all RA patients prior to TNF-inhibitor therapy and during year 2 (or when TNF-inhibitor therapy is changed), as this will occasionally pick up patients with latent TB who were initially anergic, he said.

There is no added yield to further annual testing, but the PPD skin test can be repeated if the patient has had a recent exposure, has traveled to a high-risk or endemic area, or has signs or symptoms of a mycobacterial infection.

PPD results are notoriously variable depending on who conducts the test, but results are good for 1-2 weeks, Dr. Cush said.

“It's better to have a patient come back late than not at all,” he said. “The best PPD is the one done by you and read by you.”

As an alternative—or in addition—to conventional skin tests, clinicians may want to consider using the QuantiFERON TB test, which was approved by the Food and Drug Administration in 2001 and measures the release of interferon-gamma in whole blood in response to stimulation by a purified protein derivative. Roughly 10% of QuantiFERON testing is indeterminate, but in general, clinicians can “hang their hat on the results,” he said, noting that PPD tests may be positive in those with a history of bacille Calmette-Guérin (BCG) vaccination, whereas QuantiFERON is unaffected by BCG and more truly reflects the likelihood of latent TB infection.

There is no evidence to support the practice of suspending TNF-inhibitor use in the setting of nonserious infections, unless the symptoms or signs are suggestive of a more serious infection, Dr. Cush said.

In a meta-analysis to be presented by colleague Dr. Kathryn Dao at the upcoming European League Against Rheumatism meeting in Copenhagen, the risk for nonserious infections was increased in patients with RA who received adalimumab (odds ratio, 1.39) or infliximab (OR, 1.53), but not etanercept (OR, 0.99).

“The magnitude is small, but we have to be mindful of these very common events and how they can be properly managed in patients receiving biologics,” he said.

Dr. Cush disclosed that he has been an adviser, consultant, or lecturer for Abbott Laboratories, Centocor Inc., Pfizer Inc., Roche, UCB SA, and Wyeth.

He noted he has been a clinical investigator for or received research support from Celgene Corp., Genentech Inc., Pfizer, Roche, UCB, and the Consortium of Rheumatology Researchers of North America.

While patients need flu shots and other regular immunizations, attenuated vaccines should be avoided. DR. CUSH

CHICAGO — Clinicians need to step up their use of vaccinations as part of an overall plan to reduce the risk of infection in patients with rheumatic disease who receive tumor necrosis factor inhibitors, Dr. John J. Cush said at a symposium sponsored by the American College of Rheumatology.

“We are not as good as we should be [about vaccinations], and they can really have a big impact by preventing serious infections, especially in our immunosuppressed patients,” he said.

Data from pivotal trials show that the risk of serious infectious events with the biologics is two times that with placebo. This trend did not reach statistical significance in many of the studies, but in the real world it becomes significant, said Dr. Cush, director of clinical rheumatology for the Baylor Research Institute and a professor of medicine and rheumatology at Baylor College of Medicine in Dallas.

He suggests that patients with rheumatoid arthritis (RA) should receive the yearly influenza vaccine, and that pneumococcal vaccinations should be given once, with a second dose 5 years later.

Vaccines for meningococcal disease, human papillomavirus, and hepatitis B are needed where exposure is likely, but it is important to avoid live attenuated vaccines.

The package inserts for several TNF inhibitors were also revised in 2007-2008, warning that tuberculosis has been observed with their use. Data from the British Society for Rheumatology Biologics Register on 10,403 patients taking anti-TNF agents and 3,106 patients taking only disease-modifying anti-rheumatic drugs identified 35 cases of tuberculosis, all occurring in patients on anti-TNF agents. The TB rate was 110 per 100,000 patient-years in anti-TNF-treated patients, putting them above the rate for the general U.K. and U.S. populations (6 per 100,000 patient-years) and on par with alcoholics and patients with HIV, Dr. Cush said.

Manufacturers of anti-TNF agents advise clinicians to employ tuberculosis skin testing (purified protein derivative tuberculin) prior to initiating therapy; to monitor for signs and symptoms of TB, even if the initial PPD was negative; and to initiate latent tuberculosis infection (LTBI) treatment prior to TNF therapy.

Dr. Cush suggested that patients with a positive skin test (5 mm or more) or a history of LTBI can be treated with TNF inhibitors immediately after TB therapy with isoniazid is initiated. Moreover, this practice is routine in some RA clinical trials.

Arguments for suspending anti-TNF therapy could include the belief that TB treatment confers protection, or that anti-TNF therapy may increase the potential for toxicity or may cause worsening of latent TB infection before treatment with isoniazid can start working. Dr. Cush contends that there are no data to support waiting, and although toxicity may be an issue, it can be identified early on by lab testing and physician observation. Reactivation of LTBI has not been shown to occur in anti-TNF-treated patients.

To drive home his point, Dr. Cush highlighted a study among Africans with HIV-associated TB in which eight doses of etanercept (25 mg) administered twice weekly beginning on day 4 of TB therapy actually improved TB killing and overall responses, compared with control therapy (AIDS 2004;18:257-64).

Dr. Cush acknowledged that he would not use TNF inhibitors in RA patients who have invasive fungal disease or chronic hepatitis B, or in those infected with atypical mycobacteria. Clinicians should have safeguards and reminders in place to do PPD skin tests in all RA patients prior to TNF-inhibitor therapy and during year 2 (or when TNF-inhibitor therapy is changed), as this will occasionally pick up patients with latent TB who were initially anergic, he said.

There is no added yield to further annual testing, but the PPD skin test can be repeated if the patient has had a recent exposure, has traveled to a high-risk or endemic area, or has signs or symptoms of a mycobacterial infection.

PPD results are notoriously variable depending on who conducts the test, but results are good for 1-2 weeks, Dr. Cush said.

“It's better to have a patient come back late than not at all,” he said. “The best PPD is the one done by you and read by you.”

As an alternative—or in addition—to conventional skin tests, clinicians may want to consider using the QuantiFERON TB test, which was approved by the Food and Drug Administration in 2001 and measures the release of interferon-gamma in whole blood in response to stimulation by a purified protein derivative. Roughly 10% of QuantiFERON testing is indeterminate, but in general, clinicians can “hang their hat on the results,” he said, noting that PPD tests may be positive in those with a history of bacille Calmette-Guérin (BCG) vaccination, whereas QuantiFERON is unaffected by BCG and more truly reflects the likelihood of latent TB infection.

There is no evidence to support the practice of suspending TNF-inhibitor use in the setting of nonserious infections, unless the symptoms or signs are suggestive of a more serious infection, Dr. Cush said.

In a meta-analysis to be presented by colleague Dr. Kathryn Dao at the upcoming European League Against Rheumatism meeting in Copenhagen, the risk for nonserious infections was increased in patients with RA who received adalimumab (odds ratio, 1.39) or infliximab (OR, 1.53), but not etanercept (OR, 0.99).

“The magnitude is small, but we have to be mindful of these very common events and how they can be properly managed in patients receiving biologics,” he said.

Dr. Cush disclosed that he has been an adviser, consultant, or lecturer for Abbott Laboratories, Centocor Inc., Pfizer Inc., Roche, UCB SA, and Wyeth.

He noted he has been a clinical investigator for or received research support from Celgene Corp., Genentech Inc., Pfizer, Roche, UCB, and the Consortium of Rheumatology Researchers of North America.

While patients need flu shots and other regular immunizations, attenuated vaccines should be avoided. DR. CUSH

CHICAGO — Fracture risk increases in arthritis patients within about 3 months of starting corticosteroids and remains high, according to Dr. Nelson Watts.

“How much of this is steroids and how much of this is the underlying disease is unanswered,” said Dr. Watts, director of the bone health and osteoporosis center at the University of Cincinnati.

Glucocorticoid-induced osteoporosis results from a variety of systemic effects of corticosteroids, but it's the combination of reduced bone formation and increased bone resorption that causes a “double whammy” for patients—a troubling aspect for rheumatologists, who regularly dispense corticosteroids for their patients, Dr. Watts said at a symposium sponsored by the American College of Rheumatology.

The exact dose at which corticosteroids increase fracture risk is also difficult to tease out because of the underlying disease. One study observed that fracture risk was dose dependent and significantly higher with 2.5 mg/day or more of oral prednisone, with increases of 61% in hip and 160% in vertebral fractures (J. Bone Miner. Res. 2000;15:993-1000).

“It may well be that people who need 2.5 [mg]/day of prednisone are at increased risk for fracture not because of prednisone, but because of their rheumatoid arthritis; … clearly, as the dose goes up, the risk increases,” he said.

The American College of Rheumatology just began the process of revising its 2001 guidelines for the prevention and treatment of glucocorticoid-induced osteoporosis. The current guidelines highlight lifestyle modifications, such as calcium and vitamin D supplementation, weight-bearing exercise, and minimization of alcohol intake.

There is at least one supportive trial for virtually all therapies, but several intervention trials have produced conflicting results for some agents, according to a recent review of glucocorticoids and the risk of osteoporosis (Expert Opin. Drug Saf. 2009;8:33-47).

The value of calcium and vitamin D supplementation is unclear, Dr. Watts said. In a relatively small trial in 96 RA patients on prednisone, daily supplementation with 500 IU of vitamin D and 1,000 mg of calcium carbonate per day significantly improved bone mineral density, at a rate of 0.72% in the lumbar spine and 0.85% in the trochanter per year, compared with losses of 2% and 0.9%, respectively, among patients on placebo (Ann. Intern. Med. 1996;125:961-8).

In four prospective studies in 173 patients who recently started corticosteroid therapy, however, bone loss occurred at a rate of 3%-5% per year, despite daily supplementation with 500-800 mg of calcium.

Two other studies that Dr. Watts highlighted reported no bone loss in patients who were given up to 1,000 mg per day of calcium and up to 500 IU per day of vitamin D, although he noted that these patients had been on corticosteroid therapy for at least 1 year and in most cases almost 5 years.

“It's not clear to me how much of a role vitamin D and calcium will play in preventing bone loss,” he said.

Studies show that the risk for spinal fracture falls within a year or two of stopping therapy, although hip fracture risk remains increased over baseline.

Dr. Watts disclosed that he has relationships with Amgen Inc., Eli Lilly & Co., Procter & Gamble Co., Sanofi-Aventis, Novo Nordisk Inc., and Novartis Pharmaceuticals Corp., which manufactures Reclast.

CHICAGO — Fracture risk increases in arthritis patients within about 3 months of starting corticosteroids and remains high, according to Dr. Nelson Watts.

“How much of this is steroids and how much of this is the underlying disease is unanswered,” said Dr. Watts, director of the bone health and osteoporosis center at the University of Cincinnati.

Glucocorticoid-induced osteoporosis results from a variety of systemic effects of corticosteroids, but it's the combination of reduced bone formation and increased bone resorption that causes a “double whammy” for patients—a troubling aspect for rheumatologists, who regularly dispense corticosteroids for their patients, Dr. Watts said at a symposium sponsored by the American College of Rheumatology.

The exact dose at which corticosteroids increase fracture risk is also difficult to tease out because of the underlying disease. One study observed that fracture risk was dose dependent and significantly higher with 2.5 mg/day or more of oral prednisone, with increases of 61% in hip and 160% in vertebral fractures (J. Bone Miner. Res. 2000;15:993-1000).

“It may well be that people who need 2.5 [mg]/day of prednisone are at increased risk for fracture not because of prednisone, but because of their rheumatoid arthritis; … clearly, as the dose goes up, the risk increases,” he said.

The American College of Rheumatology just began the process of revising its 2001 guidelines for the prevention and treatment of glucocorticoid-induced osteoporosis. The current guidelines highlight lifestyle modifications, such as calcium and vitamin D supplementation, weight-bearing exercise, and minimization of alcohol intake.

There is at least one supportive trial for virtually all therapies, but several intervention trials have produced conflicting results for some agents, according to a recent review of glucocorticoids and the risk of osteoporosis (Expert Opin. Drug Saf. 2009;8:33-47).

The value of calcium and vitamin D supplementation is unclear, Dr. Watts said. In a relatively small trial in 96 RA patients on prednisone, daily supplementation with 500 IU of vitamin D and 1,000 mg of calcium carbonate per day significantly improved bone mineral density, at a rate of 0.72% in the lumbar spine and 0.85% in the trochanter per year, compared with losses of 2% and 0.9%, respectively, among patients on placebo (Ann. Intern. Med. 1996;125:961-8).

In four prospective studies in 173 patients who recently started corticosteroid therapy, however, bone loss occurred at a rate of 3%-5% per year, despite daily supplementation with 500-800 mg of calcium.

Two other studies that Dr. Watts highlighted reported no bone loss in patients who were given up to 1,000 mg per day of calcium and up to 500 IU per day of vitamin D, although he noted that these patients had been on corticosteroid therapy for at least 1 year and in most cases almost 5 years.

“It's not clear to me how much of a role vitamin D and calcium will play in preventing bone loss,” he said.

Studies show that the risk for spinal fracture falls within a year or two of stopping therapy, although hip fracture risk remains increased over baseline.

Dr. Watts disclosed that he has relationships with Amgen Inc., Eli Lilly & Co., Procter & Gamble Co., Sanofi-Aventis, Novo Nordisk Inc., and Novartis Pharmaceuticals Corp., which manufactures Reclast.

CHICAGO — Fracture risk increases in arthritis patients within about 3 months of starting corticosteroids and remains high, according to Dr. Nelson Watts.

“How much of this is steroids and how much of this is the underlying disease is unanswered,” said Dr. Watts, director of the bone health and osteoporosis center at the University of Cincinnati.

Glucocorticoid-induced osteoporosis results from a variety of systemic effects of corticosteroids, but it's the combination of reduced bone formation and increased bone resorption that causes a “double whammy” for patients—a troubling aspect for rheumatologists, who regularly dispense corticosteroids for their patients, Dr. Watts said at a symposium sponsored by the American College of Rheumatology.

The exact dose at which corticosteroids increase fracture risk is also difficult to tease out because of the underlying disease. One study observed that fracture risk was dose dependent and significantly higher with 2.5 mg/day or more of oral prednisone, with increases of 61% in hip and 160% in vertebral fractures (J. Bone Miner. Res. 2000;15:993-1000).

“It may well be that people who need 2.5 [mg]/day of prednisone are at increased risk for fracture not because of prednisone, but because of their rheumatoid arthritis; … clearly, as the dose goes up, the risk increases,” he said.

The American College of Rheumatology just began the process of revising its 2001 guidelines for the prevention and treatment of glucocorticoid-induced osteoporosis. The current guidelines highlight lifestyle modifications, such as calcium and vitamin D supplementation, weight-bearing exercise, and minimization of alcohol intake.

There is at least one supportive trial for virtually all therapies, but several intervention trials have produced conflicting results for some agents, according to a recent review of glucocorticoids and the risk of osteoporosis (Expert Opin. Drug Saf. 2009;8:33-47).

The value of calcium and vitamin D supplementation is unclear, Dr. Watts said. In a relatively small trial in 96 RA patients on prednisone, daily supplementation with 500 IU of vitamin D and 1,000 mg of calcium carbonate per day significantly improved bone mineral density, at a rate of 0.72% in the lumbar spine and 0.85% in the trochanter per year, compared with losses of 2% and 0.9%, respectively, among patients on placebo (Ann. Intern. Med. 1996;125:961-8).

In four prospective studies in 173 patients who recently started corticosteroid therapy, however, bone loss occurred at a rate of 3%-5% per year, despite daily supplementation with 500-800 mg of calcium.

Two other studies that Dr. Watts highlighted reported no bone loss in patients who were given up to 1,000 mg per day of calcium and up to 500 IU per day of vitamin D, although he noted that these patients had been on corticosteroid therapy for at least 1 year and in most cases almost 5 years.

“It's not clear to me how much of a role vitamin D and calcium will play in preventing bone loss,” he said.

Studies show that the risk for spinal fracture falls within a year or two of stopping therapy, although hip fracture risk remains increased over baseline.

Dr. Watts disclosed that he has relationships with Amgen Inc., Eli Lilly & Co., Procter & Gamble Co., Sanofi-Aventis, Novo Nordisk Inc., and Novartis Pharmaceuticals Corp., which manufactures Reclast.

After participating in education and focus groups, poor, at-risk African American adolescent girls and their parents or caregivers had favorable opinions about the girls' receiving the human papillomavirus vaccine, study results suggest.

The study also found that these teens were most focused on the HPV vaccine as a way to reduce their risk for sexually transmitted diseases, rather than as a way to reduce their risk for cervical cancer.

“For this group, talking about this as an STD vaccine is going to be what hits home for them,” said Amy Leader, Dr.P.H., who presented the results on behalf of principal investigator Dr. Ian Frank. Both researchers are with the University of Pennsylvania, Philadelphia.

The study is part of a larger project that is designed to raise awareness about HPV and cervical cancer and to increase vaccination rates in five inner-city neighborhoods in Philadelphia and in communities in northeast Pennsylvania, explained Dr. Leader, research director at the Center of Excellence in Cancer Communication Research at the university.

“This is an underserved population of girls at very high risk of HPV due to their behavior, and they have low access and awareness of the vaccine,” Dr. Leader said in an interview. “These are exactly the type of girls who will benefit most from this vaccine.”

Among 71 teens who were recruited from inner-city recreation centers and community nonprofit groups in Philadelphia, 40% reported having started the HPV vaccine series; 44% of those who had not yet started indicated they were “very likely” or “likely” to do so soon.

The 40% one-time vaccination rate in the study may be an overestimation, she said, because many of the girls were unsure if they had specifically received the HPV vaccine or if they had completed the series. Recent data show that only 25% of American adolescents received at least one dose of the HPV vaccine (MMWR 2008;57:1100-3).

The girls' average age was 15 years, and roughly 60% had their first sexual encounter when they were 14 years old. Overall, 94% were black, 3% were white, and 3% were identified as “other.”

Regardless of vaccination status, a majority (79%) felt that getting the HPV vaccine was either a “very good” or “good” idea. One person said that starting the vaccine would be “bad,” Dr. Leader reported at the American Association for Cancer Research conference on the science of cancer health disparities.

Most (93%) of the parents and caregivers were female; they reported an annual household income of $20,000 or less (66%) and had some form of insurance coverage for their daughters (85%).

In the study, the girls were given a brief description of the vaccine prior to participating in focus groups. In general, they had a low understanding of both HPV and the vaccine. (Gardasil was approved in June 2006 for girls and women aged 9-26 years, and is given in three shots over 6 months.)

Although many of the girls could recall Gardasil ads on television and could easily list more than a dozen STDs off the top of their head, HPV was typically not among them, she said. The girls were, however, extremely concerned about protecting themselves from STDs and the social stigma that is associated with having an STD. A majority of girls believed that starting the vaccine would be a safe (76%) and wise (81%) decision. Parents and other caregivers also exhibited limited knowledge of HPV and the vaccine, but were largely receptive to its use.

Despite its strong advertising campaign, widespread utilization of Gardasil has been slow for a variety of reasons, including Merck & Co.'s initial call for mandatory vaccination, involving a roughly $375 price tag for the series; concerns about long-term efficacy and possible side effects; and the belief by some that adolescents would be more likely to engage in sexual relations if they were inoculated against the human papillomavirus, which is spread through sexual contact.

The study was funded by the Pennsylvania Department of Health. The investigators reported no conflicts of interest.

After participating in education and focus groups, poor, at-risk African American adolescent girls and their parents or caregivers had favorable opinions about the girls' receiving the human papillomavirus vaccine, study results suggest.

The study also found that these teens were most focused on the HPV vaccine as a way to reduce their risk for sexually transmitted diseases, rather than as a way to reduce their risk for cervical cancer.

“For this group, talking about this as an STD vaccine is going to be what hits home for them,” said Amy Leader, Dr.P.H., who presented the results on behalf of principal investigator Dr. Ian Frank. Both researchers are with the University of Pennsylvania, Philadelphia.

The study is part of a larger project that is designed to raise awareness about HPV and cervical cancer and to increase vaccination rates in five inner-city neighborhoods in Philadelphia and in communities in northeast Pennsylvania, explained Dr. Leader, research director at the Center of Excellence in Cancer Communication Research at the university.

“This is an underserved population of girls at very high risk of HPV due to their behavior, and they have low access and awareness of the vaccine,” Dr. Leader said in an interview. “These are exactly the type of girls who will benefit most from this vaccine.”

Among 71 teens who were recruited from inner-city recreation centers and community nonprofit groups in Philadelphia, 40% reported having started the HPV vaccine series; 44% of those who had not yet started indicated they were “very likely” or “likely” to do so soon.

The 40% one-time vaccination rate in the study may be an overestimation, she said, because many of the girls were unsure if they had specifically received the HPV vaccine or if they had completed the series. Recent data show that only 25% of American adolescents received at least one dose of the HPV vaccine (MMWR 2008;57:1100-3).

The girls' average age was 15 years, and roughly 60% had their first sexual encounter when they were 14 years old. Overall, 94% were black, 3% were white, and 3% were identified as “other.”

Regardless of vaccination status, a majority (79%) felt that getting the HPV vaccine was either a “very good” or “good” idea. One person said that starting the vaccine would be “bad,” Dr. Leader reported at the American Association for Cancer Research conference on the science of cancer health disparities.

Most (93%) of the parents and caregivers were female; they reported an annual household income of $20,000 or less (66%) and had some form of insurance coverage for their daughters (85%).

In the study, the girls were given a brief description of the vaccine prior to participating in focus groups. In general, they had a low understanding of both HPV and the vaccine. (Gardasil was approved in June 2006 for girls and women aged 9-26 years, and is given in three shots over 6 months.)

Although many of the girls could recall Gardasil ads on television and could easily list more than a dozen STDs off the top of their head, HPV was typically not among them, she said. The girls were, however, extremely concerned about protecting themselves from STDs and the social stigma that is associated with having an STD. A majority of girls believed that starting the vaccine would be a safe (76%) and wise (81%) decision. Parents and other caregivers also exhibited limited knowledge of HPV and the vaccine, but were largely receptive to its use.

Despite its strong advertising campaign, widespread utilization of Gardasil has been slow for a variety of reasons, including Merck & Co.'s initial call for mandatory vaccination, involving a roughly $375 price tag for the series; concerns about long-term efficacy and possible side effects; and the belief by some that adolescents would be more likely to engage in sexual relations if they were inoculated against the human papillomavirus, which is spread through sexual contact.

The study was funded by the Pennsylvania Department of Health. The investigators reported no conflicts of interest.

After participating in education and focus groups, poor, at-risk African American adolescent girls and their parents or caregivers had favorable opinions about the girls' receiving the human papillomavirus vaccine, study results suggest.

The study also found that these teens were most focused on the HPV vaccine as a way to reduce their risk for sexually transmitted diseases, rather than as a way to reduce their risk for cervical cancer.

“For this group, talking about this as an STD vaccine is going to be what hits home for them,” said Amy Leader, Dr.P.H., who presented the results on behalf of principal investigator Dr. Ian Frank. Both researchers are with the University of Pennsylvania, Philadelphia.

The study is part of a larger project that is designed to raise awareness about HPV and cervical cancer and to increase vaccination rates in five inner-city neighborhoods in Philadelphia and in communities in northeast Pennsylvania, explained Dr. Leader, research director at the Center of Excellence in Cancer Communication Research at the university.

“This is an underserved population of girls at very high risk of HPV due to their behavior, and they have low access and awareness of the vaccine,” Dr. Leader said in an interview. “These are exactly the type of girls who will benefit most from this vaccine.”

Among 71 teens who were recruited from inner-city recreation centers and community nonprofit groups in Philadelphia, 40% reported having started the HPV vaccine series; 44% of those who had not yet started indicated they were “very likely” or “likely” to do so soon.

The 40% one-time vaccination rate in the study may be an overestimation, she said, because many of the girls were unsure if they had specifically received the HPV vaccine or if they had completed the series. Recent data show that only 25% of American adolescents received at least one dose of the HPV vaccine (MMWR 2008;57:1100-3).

The girls' average age was 15 years, and roughly 60% had their first sexual encounter when they were 14 years old. Overall, 94% were black, 3% were white, and 3% were identified as “other.”

Regardless of vaccination status, a majority (79%) felt that getting the HPV vaccine was either a “very good” or “good” idea. One person said that starting the vaccine would be “bad,” Dr. Leader reported at the American Association for Cancer Research conference on the science of cancer health disparities.

Most (93%) of the parents and caregivers were female; they reported an annual household income of $20,000 or less (66%) and had some form of insurance coverage for their daughters (85%).

In the study, the girls were given a brief description of the vaccine prior to participating in focus groups. In general, they had a low understanding of both HPV and the vaccine. (Gardasil was approved in June 2006 for girls and women aged 9-26 years, and is given in three shots over 6 months.)

Although many of the girls could recall Gardasil ads on television and could easily list more than a dozen STDs off the top of their head, HPV was typically not among them, she said. The girls were, however, extremely concerned about protecting themselves from STDs and the social stigma that is associated with having an STD. A majority of girls believed that starting the vaccine would be a safe (76%) and wise (81%) decision. Parents and other caregivers also exhibited limited knowledge of HPV and the vaccine, but were largely receptive to its use.

Despite its strong advertising campaign, widespread utilization of Gardasil has been slow for a variety of reasons, including Merck & Co.'s initial call for mandatory vaccination, involving a roughly $375 price tag for the series; concerns about long-term efficacy and possible side effects; and the belief by some that adolescents would be more likely to engage in sexual relations if they were inoculated against the human papillomavirus, which is spread through sexual contact.

The study was funded by the Pennsylvania Department of Health. The investigators reported no conflicts of interest.

AUSTIN, TEX. — The release of the long-awaited Joint Commission-sponsored palliative care certificate program has been put on hold in order to complete a strategic planning process, Dr. Diane Meier said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

The certificate program was expected in August 2008 after the Joint Commission announced it would release a new certificate for hospital palliative care programs. The commission convened an expert panel to establish quality standards and conducted market research showing strong interest in the program.

But that research was conducted before the economy began to tank, said Charles Mowll, executive vice president for business development, government, and external relations at the Joint Commission.

“Because of the change in the economic environment, we want to proceed carefully,” he said in an interview. “Unfortunately, it's sometimes difficult to convert that enthusiasm to spending the resources and energy to pursue and obtain certification. The next steps for us are to refresh that market research and get a more contemporary view of the world and interest in the program. But it's a clear message that we have a significant collective investment in palliative care certification.”

The fate of the program should be decided sometime this summer, he said.

In the meantime, the Center to Advance Palliative Care (CAPC) at the Mount Sinai School of Medicine in New York has agreed to advertise the program and raise funds to help offset costs to the Joint Commission to develop it, said Dr. Meier, director of CAPC and professor of geriatrics and internal medicine at Mount Sinai.

“Development of a quality assessment program to ensure high standards for the nation's 1,300 hospital palliative care programs is of the highest priority,” she said in an interview.

P Low-hanging fruit. Cash-strapped states are eyeing the nursing home Medicaid Hospice Benefit as a way to shore up their budgets.

“There are a lot of hospices making a very large profit on stable long-term nursing home patients that are tarring the entire industry,” Dr. Meier said. “The problem is that rather than identify and censor the bad actors, they [state and federal policy makers] just want to eliminate the benefit.”

In late 2008, Florida proposed eliminating reimbursement for hospice in nursing homes, claiming that it would save the state $343 million. The effort was defeated after a statewide group, Florida Hospices and Palliative Care, hired its own research firm, arguing that the move would actually boost state health care costs by $3.7 million.

President Obama provided some breathing room by imposing a 1-year moratorium on hospice rate cuts through Sept. 30, 2009, as part of the economic stimulus plan. The National Hospice and Palliative Care Organization (NHPCO) is urging members to push for a permanent freeze.

“We're not expecting that this will completely go away,” said audience member Judy Lund Person, NHPCO vice president of regulatory and state leadership. “There have been lots of discussions about whether it's double-dipping. … We don't believe that that's true, but it's an area where we have to be extraordinarily careful.”

P Part of the solution. In other circles, hospice and palliative care are being viewed as part of the solution to the health care crisis. The National Priorities Partnership, convened by the National Quality Forum in 2008, named palliative and end-of-life care as one of six national priorities for transforming the nation's health care system.

Dr. Meier noted that another benchmarking group, HealthGrades, is getting increasing inquiries for help in starting palliative care programs, a sign that health care quality assessment organizations are seeing these programs as a way to get a handle on costs.

P Coding conundrum. Although the Centers for Medicare and Medicaid Services began recognizing hospice and palliative care as a new physician specialty as of 2009, a specific specialty code won't be assigned until this fall, said copresenter Lynn Hill Spragens, CEO and president of the consulting firm Spragens & Associates, Durham, N.C. A delay in implementation is not unusual, but in the meantime reimbursement denials continue.

Core causes of denials include a lack of professional preparation to do Part B billing, misinformed or underinformed billing specialists, and an increasing number of providers from different core specialties delivering palliative care services in the same hospital.

Many programs are staffed by specialists with primary credentialing in a specialty such as geriatrics or hospital medicine, who are also board certified in hospice and palliative medicine, Ms. Spragens said. Pending the assignment of the new CMS specialty code, when they receive referrals from physicians in their primary specialty, there is a high potential for bill denial, unless there is very careful documentation by the provider and the billing office.

Until the new specialty code is in place, she advises providers to use the 77 modifier to report a repeat procedure by another physician, include notation about palliative care on the bill, and follow up thoroughly with denials to identify acceptable documentation with payers. After the specialty code is assigned, providers will need to revise their credentialing information, she said.

Dr. Meier and Ms. Spragens reported no conflicts of interest.

Health care quality assessment organizations are seeing palliative care as a way to control costs. DR. MEIER

AUSTIN, TEX. — The release of the long-awaited Joint Commission-sponsored palliative care certificate program has been put on hold in order to complete a strategic planning process, Dr. Diane Meier said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

The certificate program was expected in August 2008 after the Joint Commission announced it would release a new certificate for hospital palliative care programs. The commission convened an expert panel to establish quality standards and conducted market research showing strong interest in the program.

But that research was conducted before the economy began to tank, said Charles Mowll, executive vice president for business development, government, and external relations at the Joint Commission.

“Because of the change in the economic environment, we want to proceed carefully,” he said in an interview. “Unfortunately, it's sometimes difficult to convert that enthusiasm to spending the resources and energy to pursue and obtain certification. The next steps for us are to refresh that market research and get a more contemporary view of the world and interest in the program. But it's a clear message that we have a significant collective investment in palliative care certification.”

The fate of the program should be decided sometime this summer, he said.

In the meantime, the Center to Advance Palliative Care (CAPC) at the Mount Sinai School of Medicine in New York has agreed to advertise the program and raise funds to help offset costs to the Joint Commission to develop it, said Dr. Meier, director of CAPC and professor of geriatrics and internal medicine at Mount Sinai.

“Development of a quality assessment program to ensure high standards for the nation's 1,300 hospital palliative care programs is of the highest priority,” she said in an interview.

P Low-hanging fruit. Cash-strapped states are eyeing the nursing home Medicaid Hospice Benefit as a way to shore up their budgets.

“There are a lot of hospices making a very large profit on stable long-term nursing home patients that are tarring the entire industry,” Dr. Meier said. “The problem is that rather than identify and censor the bad actors, they [state and federal policy makers] just want to eliminate the benefit.”

In late 2008, Florida proposed eliminating reimbursement for hospice in nursing homes, claiming that it would save the state $343 million. The effort was defeated after a statewide group, Florida Hospices and Palliative Care, hired its own research firm, arguing that the move would actually boost state health care costs by $3.7 million.

President Obama provided some breathing room by imposing a 1-year moratorium on hospice rate cuts through Sept. 30, 2009, as part of the economic stimulus plan. The National Hospice and Palliative Care Organization (NHPCO) is urging members to push for a permanent freeze.

“We're not expecting that this will completely go away,” said audience member Judy Lund Person, NHPCO vice president of regulatory and state leadership. “There have been lots of discussions about whether it's double-dipping. … We don't believe that that's true, but it's an area where we have to be extraordinarily careful.”

P Part of the solution. In other circles, hospice and palliative care are being viewed as part of the solution to the health care crisis. The National Priorities Partnership, convened by the National Quality Forum in 2008, named palliative and end-of-life care as one of six national priorities for transforming the nation's health care system.

Dr. Meier noted that another benchmarking group, HealthGrades, is getting increasing inquiries for help in starting palliative care programs, a sign that health care quality assessment organizations are seeing these programs as a way to get a handle on costs.

P Coding conundrum. Although the Centers for Medicare and Medicaid Services began recognizing hospice and palliative care as a new physician specialty as of 2009, a specific specialty code won't be assigned until this fall, said copresenter Lynn Hill Spragens, CEO and president of the consulting firm Spragens & Associates, Durham, N.C. A delay in implementation is not unusual, but in the meantime reimbursement denials continue.

Core causes of denials include a lack of professional preparation to do Part B billing, misinformed or underinformed billing specialists, and an increasing number of providers from different core specialties delivering palliative care services in the same hospital.

Many programs are staffed by specialists with primary credentialing in a specialty such as geriatrics or hospital medicine, who are also board certified in hospice and palliative medicine, Ms. Spragens said. Pending the assignment of the new CMS specialty code, when they receive referrals from physicians in their primary specialty, there is a high potential for bill denial, unless there is very careful documentation by the provider and the billing office.

Until the new specialty code is in place, she advises providers to use the 77 modifier to report a repeat procedure by another physician, include notation about palliative care on the bill, and follow up thoroughly with denials to identify acceptable documentation with payers. After the specialty code is assigned, providers will need to revise their credentialing information, she said.

Dr. Meier and Ms. Spragens reported no conflicts of interest.

Health care quality assessment organizations are seeing palliative care as a way to control costs. DR. MEIER

AUSTIN, TEX. — The release of the long-awaited Joint Commission-sponsored palliative care certificate program has been put on hold in order to complete a strategic planning process, Dr. Diane Meier said at the annual meeting of the American Academy of Hospice and Palliative Medicine.

The certificate program was expected in August 2008 after the Joint Commission announced it would release a new certificate for hospital palliative care programs. The commission convened an expert panel to establish quality standards and conducted market research showing strong interest in the program.

But that research was conducted before the economy began to tank, said Charles Mowll, executive vice president for business development, government, and external relations at the Joint Commission.

“Because of the change in the economic environment, we want to proceed carefully,” he said in an interview. “Unfortunately, it's sometimes difficult to convert that enthusiasm to spending the resources and energy to pursue and obtain certification. The next steps for us are to refresh that market research and get a more contemporary view of the world and interest in the program. But it's a clear message that we have a significant collective investment in palliative care certification.”

The fate of the program should be decided sometime this summer, he said.

In the meantime, the Center to Advance Palliative Care (CAPC) at the Mount Sinai School of Medicine in New York has agreed to advertise the program and raise funds to help offset costs to the Joint Commission to develop it, said Dr. Meier, director of CAPC and professor of geriatrics and internal medicine at Mount Sinai.

“Development of a quality assessment program to ensure high standards for the nation's 1,300 hospital palliative care programs is of the highest priority,” she said in an interview.

P Low-hanging fruit. Cash-strapped states are eyeing the nursing home Medicaid Hospice Benefit as a way to shore up their budgets.

“There are a lot of hospices making a very large profit on stable long-term nursing home patients that are tarring the entire industry,” Dr. Meier said. “The problem is that rather than identify and censor the bad actors, they [state and federal policy makers] just want to eliminate the benefit.”

In late 2008, Florida proposed eliminating reimbursement for hospice in nursing homes, claiming that it would save the state $343 million. The effort was defeated after a statewide group, Florida Hospices and Palliative Care, hired its own research firm, arguing that the move would actually boost state health care costs by $3.7 million.

President Obama provided some breathing room by imposing a 1-year moratorium on hospice rate cuts through Sept. 30, 2009, as part of the economic stimulus plan. The National Hospice and Palliative Care Organization (NHPCO) is urging members to push for a permanent freeze.

“We're not expecting that this will completely go away,” said audience member Judy Lund Person, NHPCO vice president of regulatory and state leadership. “There have been lots of discussions about whether it's double-dipping. … We don't believe that that's true, but it's an area where we have to be extraordinarily careful.”

P Part of the solution. In other circles, hospice and palliative care are being viewed as part of the solution to the health care crisis. The National Priorities Partnership, convened by the National Quality Forum in 2008, named palliative and end-of-life care as one of six national priorities for transforming the nation's health care system.

Dr. Meier noted that another benchmarking group, HealthGrades, is getting increasing inquiries for help in starting palliative care programs, a sign that health care quality assessment organizations are seeing these programs as a way to get a handle on costs.

P Coding conundrum. Although the Centers for Medicare and Medicaid Services began recognizing hospice and palliative care as a new physician specialty as of 2009, a specific specialty code won't be assigned until this fall, said copresenter Lynn Hill Spragens, CEO and president of the consulting firm Spragens & Associates, Durham, N.C. A delay in implementation is not unusual, but in the meantime reimbursement denials continue.

Core causes of denials include a lack of professional preparation to do Part B billing, misinformed or underinformed billing specialists, and an increasing number of providers from different core specialties delivering palliative care services in the same hospital.

Many programs are staffed by specialists with primary credentialing in a specialty such as geriatrics or hospital medicine, who are also board certified in hospice and palliative medicine, Ms. Spragens said. Pending the assignment of the new CMS specialty code, when they receive referrals from physicians in their primary specialty, there is a high potential for bill denial, unless there is very careful documentation by the provider and the billing office.

Until the new specialty code is in place, she advises providers to use the 77 modifier to report a repeat procedure by another physician, include notation about palliative care on the bill, and follow up thoroughly with denials to identify acceptable documentation with payers. After the specialty code is assigned, providers will need to revise their credentialing information, she said.

Dr. Meier and Ms. Spragens reported no conflicts of interest.

Health care quality assessment organizations are seeing palliative care as a way to control costs. DR. MEIER

AUSTIN, TEX. — Some palliative chemotherapy regimens can cost up to $100,000 a year for end-of-life care. Yet oncologists and their patients often do not discuss less costly, alternative advanced-care options.

“This is going to come to the fore over the next year or two, as fewer and fewer people have insurance,” Dr. Thomas Smith said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine. “We spend twice as much as any other country for the same cancer results.”

He noted that some insurance companies may soon be asking patients to pay more for third-line treatments because of their reduced possibility of benefit. If hospice is introduced early in treatment as an end-of-life option, moreover, patients tend to switch earlier and spend more time in hospice, thereby reducing patient and hospital costs. Currently, one-third of patients with cancer spend fewer than 7 days in hospice, he said.

A sea change may already be underway. Kaiser Permanente has put hospice and palliative care teams in all of its major markets, and many insurers (such as UnitedHealthcare) are expected to roll out their plans for concurrent oncology and palliative care later this year, said Dr. Smith, professor of palliative care research at Virginia Commonwealth University in Richmond.

Part of the problem is that neither oncologists nor patients want to talk about death. A recent study showed that oncologists discussed prognosis 39% of the time and impending death only 37% of the time (JAMA 2008;300:1665–73). Of 111 inpatients with cancer, only 23 said they wished to discuss their advanced-care preferences with their oncologists, and 64 said they would prefer to do so with an admitting doctor (J. Palliat. Med. 2000;3:27–35).

Reimbursement is also a thorny issue. The Medicare reimbursement for hospice and palliative care hasn't kept pace with inflation or current oncology practice trends, even though patients with cancer account for about 40% of Medicare drug costs, Dr. Smith said. Oncologists are reimbursed far more for administering chemotherapeutic agents than for having discussions about prognosis and palliative care options.

It's also hard to find good “bad” news, Dr. Smith said. He noted that treatment options for recurrent pancreatic cancer on the National Cancer Institute's Web site (www.cancer.gov

“How about putting on there [that] in fact 95% of people are going to be dead within a year … and suggest hospice and palliative care?” he asked. “I've been beating on the NCI for 15 years on this, and will probably die before it happens.”

For those who say patients can't handle the truth, Dr. Smith said it is nearly impossible to take away hope. Most cancer patients are overly optimistic about their prognosis and are willing to take a phase I drug, even if it has a 10% chance of killing them.

New data suggest that one of the biggest fears of the terminally ill is abandonment by their physician or nurse when disease-modifying therapy is no longer an option (Arch. Intern. Med. 2009;169:474–9).

Written treatment plans offer patients truthful information about prognosis and treatment effectiveness, Dr. Smith said. He has been using them in his practice for years, and noted that the American Society of Clinical Oncology now makes these plans available online (www.asco.org

During the same presentation, Dr. Sarah E. Harrington offered suggestions for what oncologists should say about illness and patient options. They include being realistic about the goals of therapy; defining cure, remission, response, and what is likely to happen; and being negative, if appropriate.

“Language is important. Patients can easily mistake a 20% chance of response for a 20% chance of cure,” said Dr. Harrington, also at Virginia Commonwealth.

The subject of hospice should be brought up early as part of routine oncologic care, rather than delayed until death is imminent. Oncologists should be especially realistic about nth-line chemotherapy. If no proof of benefit is available, don't offer it, she said. To avoid feelings of abandonment, oncologists should tell their patients they will not abandon them if they enroll in hospice.

Dr. Harrington and Dr. Smith referred the audience to a recent article in which they discussed questions patients should consider when asking about palliative chemotherapy, and what oncologists should or should not do or say about chemotherapy for advanced cancer (JAMA 2008;299:2667–78).

They reported no financial disclosures.

AUSTIN, TEX. — Some palliative chemotherapy regimens can cost up to $100,000 a year for end-of-life care. Yet oncologists and their patients often do not discuss less costly, alternative advanced-care options.

“This is going to come to the fore over the next year or two, as fewer and fewer people have insurance,” Dr. Thomas Smith said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine. “We spend twice as much as any other country for the same cancer results.”

He noted that some insurance companies may soon be asking patients to pay more for third-line treatments because of their reduced possibility of benefit. If hospice is introduced early in treatment as an end-of-life option, moreover, patients tend to switch earlier and spend more time in hospice, thereby reducing patient and hospital costs. Currently, one-third of patients with cancer spend fewer than 7 days in hospice, he said.

A sea change may already be underway. Kaiser Permanente has put hospice and palliative care teams in all of its major markets, and many insurers (such as UnitedHealthcare) are expected to roll out their plans for concurrent oncology and palliative care later this year, said Dr. Smith, professor of palliative care research at Virginia Commonwealth University in Richmond.

Part of the problem is that neither oncologists nor patients want to talk about death. A recent study showed that oncologists discussed prognosis 39% of the time and impending death only 37% of the time (JAMA 2008;300:1665–73). Of 111 inpatients with cancer, only 23 said they wished to discuss their advanced-care preferences with their oncologists, and 64 said they would prefer to do so with an admitting doctor (J. Palliat. Med. 2000;3:27–35).

Reimbursement is also a thorny issue. The Medicare reimbursement for hospice and palliative care hasn't kept pace with inflation or current oncology practice trends, even though patients with cancer account for about 40% of Medicare drug costs, Dr. Smith said. Oncologists are reimbursed far more for administering chemotherapeutic agents than for having discussions about prognosis and palliative care options.

It's also hard to find good “bad” news, Dr. Smith said. He noted that treatment options for recurrent pancreatic cancer on the National Cancer Institute's Web site (www.cancer.gov

“How about putting on there [that] in fact 95% of people are going to be dead within a year … and suggest hospice and palliative care?” he asked. “I've been beating on the NCI for 15 years on this, and will probably die before it happens.”

For those who say patients can't handle the truth, Dr. Smith said it is nearly impossible to take away hope. Most cancer patients are overly optimistic about their prognosis and are willing to take a phase I drug, even if it has a 10% chance of killing them.

New data suggest that one of the biggest fears of the terminally ill is abandonment by their physician or nurse when disease-modifying therapy is no longer an option (Arch. Intern. Med. 2009;169:474–9).

Written treatment plans offer patients truthful information about prognosis and treatment effectiveness, Dr. Smith said. He has been using them in his practice for years, and noted that the American Society of Clinical Oncology now makes these plans available online (www.asco.org

During the same presentation, Dr. Sarah E. Harrington offered suggestions for what oncologists should say about illness and patient options. They include being realistic about the goals of therapy; defining cure, remission, response, and what is likely to happen; and being negative, if appropriate.

“Language is important. Patients can easily mistake a 20% chance of response for a 20% chance of cure,” said Dr. Harrington, also at Virginia Commonwealth.

The subject of hospice should be brought up early as part of routine oncologic care, rather than delayed until death is imminent. Oncologists should be especially realistic about nth-line chemotherapy. If no proof of benefit is available, don't offer it, she said. To avoid feelings of abandonment, oncologists should tell their patients they will not abandon them if they enroll in hospice.

Dr. Harrington and Dr. Smith referred the audience to a recent article in which they discussed questions patients should consider when asking about palliative chemotherapy, and what oncologists should or should not do or say about chemotherapy for advanced cancer (JAMA 2008;299:2667–78).

They reported no financial disclosures.

AUSTIN, TEX. — Some palliative chemotherapy regimens can cost up to $100,000 a year for end-of-life care. Yet oncologists and their patients often do not discuss less costly, alternative advanced-care options.

“This is going to come to the fore over the next year or two, as fewer and fewer people have insurance,” Dr. Thomas Smith said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine. “We spend twice as much as any other country for the same cancer results.”

He noted that some insurance companies may soon be asking patients to pay more for third-line treatments because of their reduced possibility of benefit. If hospice is introduced early in treatment as an end-of-life option, moreover, patients tend to switch earlier and spend more time in hospice, thereby reducing patient and hospital costs. Currently, one-third of patients with cancer spend fewer than 7 days in hospice, he said.

A sea change may already be underway. Kaiser Permanente has put hospice and palliative care teams in all of its major markets, and many insurers (such as UnitedHealthcare) are expected to roll out their plans for concurrent oncology and palliative care later this year, said Dr. Smith, professor of palliative care research at Virginia Commonwealth University in Richmond.

Part of the problem is that neither oncologists nor patients want to talk about death. A recent study showed that oncologists discussed prognosis 39% of the time and impending death only 37% of the time (JAMA 2008;300:1665–73). Of 111 inpatients with cancer, only 23 said they wished to discuss their advanced-care preferences with their oncologists, and 64 said they would prefer to do so with an admitting doctor (J. Palliat. Med. 2000;3:27–35).

Reimbursement is also a thorny issue. The Medicare reimbursement for hospice and palliative care hasn't kept pace with inflation or current oncology practice trends, even though patients with cancer account for about 40% of Medicare drug costs, Dr. Smith said. Oncologists are reimbursed far more for administering chemotherapeutic agents than for having discussions about prognosis and palliative care options.

It's also hard to find good “bad” news, Dr. Smith said. He noted that treatment options for recurrent pancreatic cancer on the National Cancer Institute's Web site (www.cancer.gov

“How about putting on there [that] in fact 95% of people are going to be dead within a year … and suggest hospice and palliative care?” he asked. “I've been beating on the NCI for 15 years on this, and will probably die before it happens.”

For those who say patients can't handle the truth, Dr. Smith said it is nearly impossible to take away hope. Most cancer patients are overly optimistic about their prognosis and are willing to take a phase I drug, even if it has a 10% chance of killing them.

New data suggest that one of the biggest fears of the terminally ill is abandonment by their physician or nurse when disease-modifying therapy is no longer an option (Arch. Intern. Med. 2009;169:474–9).

Written treatment plans offer patients truthful information about prognosis and treatment effectiveness, Dr. Smith said. He has been using them in his practice for years, and noted that the American Society of Clinical Oncology now makes these plans available online (www.asco.org

During the same presentation, Dr. Sarah E. Harrington offered suggestions for what oncologists should say about illness and patient options. They include being realistic about the goals of therapy; defining cure, remission, response, and what is likely to happen; and being negative, if appropriate.

“Language is important. Patients can easily mistake a 20% chance of response for a 20% chance of cure,” said Dr. Harrington, also at Virginia Commonwealth.

The subject of hospice should be brought up early as part of routine oncologic care, rather than delayed until death is imminent. Oncologists should be especially realistic about nth-line chemotherapy. If no proof of benefit is available, don't offer it, she said. To avoid feelings of abandonment, oncologists should tell their patients they will not abandon them if they enroll in hospice.

Dr. Harrington and Dr. Smith referred the audience to a recent article in which they discussed questions patients should consider when asking about palliative chemotherapy, and what oncologists should or should not do or say about chemotherapy for advanced cancer (JAMA 2008;299:2667–78).

They reported no financial disclosures.

AUSTIN, TEX. — Many new medications relevant to palliative care have come on the market recently or are about to, hospital pharmacist Mary Lynn McPherson, Pharm.D., said at the American Academy of Hospice and Palliative Medicine annual meeting.

Dr. McPherson described several new prescription drugs and over-the-counter therapies that may often be given to patients at the end of life.

Dr. McPherson commented on the following products:

▸ Dexlansoprazole (Kapidex) delayed-release capsules were approved in late January for the treatment of heartburn associated with gastroesophageal reflux disease. This R-isomer of lansoprazole (Prevacid) comes to market just as Prevacid is expected to go generic. Dexlansoprazole is the first proton pump inhibitor (PPI) with a dual delayed-release formulation, allowing doses of 30–60 mg a day, versus 15–30 mg a day for Prevacid. Costs per month are $150 for dexlansoprazole and $168 for Prevacid.

“We get the patient frequently in my practice in a hospice on a PPI they don't even need that's been advertised to death,” said Dr. McPherson, a professor of pharmacy at the University of Maryland, Baltimore. “You know, the purple pill, [but] it doesn't work any better than the 80 cents a day over-the-counter omeprazole [Prilosec]. We only provide a PPI if the patient is on a steroid or nonsteroidal that we are also providing.”

▸ Sancuso is a transdermal patch designed to deliver 3.1 mg of granisetron over 24 hours to prevent emesis caused by moderate- and high-risk emetogenic drugs. Approved by the Food and Drug Administration last fall, the patch is applied to the upper arm at least 24 hours before the first chemotherapy session and can be worn for up to 7 days. In clinical trials, it has been shown to have equal efficacy to 2 mg oral granisetron per day, Dr. McPherson said. Cost is $287 per patch.

The patch may be a better option for inpatient palliative care than for home-based hospice, where Haldol (haloperidol) is the mainstay for nausea, she said.

▸ Zolpidem (ZolpiMist) 5-mg and 10-mg oral spray was approved in late December 2008 for the short-term treatment of difficulties getting to sleep. The spray acts quickly, reaching therapeutic levels within the body in 15 minutes. Patients should be prepared to spend 7–8 hours in bed after receiving the drug.

▸ Metoclopramide products, which include Reglan (metoclopramide) tablets and injections, received a black box warning in February because chronic use has been linked to tardive dyskinesia. Patients at the end of life typically are treated with up to 40 mg a day of metoclopramide for less than 3 months, but caution should be used in elderly patients, especially women, and in those receiving both Reglan and Haldol because the combination doubles the risk of tardive dyskinesia, Dr. McPherson said.

▸ Tapentadol, a centrally acting analgesic with potency between those of morphine and tramadol, was approved at the end of 2008 for relief of moderate to severe acute pain in adults. Although not approved for chronic pain, it may be of use in hospice and palliative care, Dr. McPherson said. Tapentadol is under review by the Drug Enforcement Administration and is expected to be a scheduled drug.

P Tramadol is not a controlled substance at the federal level, but it may be heading that way, Dr. McPherson said. Arkansas and Kentucky have made it a schedule IV drug, and authorities in North Dakota, Ohio, and Wyoming are tracking tramadol usage through their prescription drug monitoring program as if it were controlled.

▸ Propoxyphene may be on the chopping block after two FDA advisory committees narrowly voted on Jan. 30 to recommend discontinued marketing of Darvon and Darvocet for mild to moderate pain. Propoxyphene is banned in the United Kingdom and is rarely used in Canada, but it is among the top 25 most prescribed drugs in the United States, Dr. McPherson said. She added that physicians like it because it causes less stomach upset than other opioids and can be taken by patients allergic to morphine and hydrocodone.

Propoxyphene is far from benign, Dr. McPherson said, noting that both the drug and its metabolite are cardiotoxic. Propoxyphene was a factor in 5.6% of drug-related deaths in the United States from 1981 to 1999, she said.

▸ OTC products. Emuprofen is a topically administered analgesic that contains ibuprofen and oil from the fat of the emu. It's being marketed as an anti-inflammatory and an alternative to systemic NSAID therapy for various painful conditions. Cost is about $35 for a small jar. The cream is about 10% ibuprofen. Rash and itching at the application site have been reported in up to 15% of patients.

Rain Dry Mouth Spray may be another therapeutic option for xerostomia, which affects 20% of the U.S. population and is common in people with head and neck cancer. The active ingredient is xylitol, a sugar alcohol, which can raise blood glucose if overused. Cost is about $14 for 4.5 ounces.

Tums QuickPak is a calcium carbonate powder that dissolves instantly on the tongue without the need for water and is the equivalent of two regular-strength Tums. It can be used as a daily calcium source, and for patients who can no longer swallow, she said.

Dr. McPherson disclosed that she is a consultant for Alpharma Inc.

AUSTIN, TEX. — Many new medications relevant to palliative care have come on the market recently or are about to, hospital pharmacist Mary Lynn McPherson, Pharm.D., said at the American Academy of Hospice and Palliative Medicine annual meeting.

Dr. McPherson described several new prescription drugs and over-the-counter therapies that may often be given to patients at the end of life.

Dr. McPherson commented on the following products:

▸ Dexlansoprazole (Kapidex) delayed-release capsules were approved in late January for the treatment of heartburn associated with gastroesophageal reflux disease. This R-isomer of lansoprazole (Prevacid) comes to market just as Prevacid is expected to go generic. Dexlansoprazole is the first proton pump inhibitor (PPI) with a dual delayed-release formulation, allowing doses of 30–60 mg a day, versus 15–30 mg a day for Prevacid. Costs per month are $150 for dexlansoprazole and $168 for Prevacid.

“We get the patient frequently in my practice in a hospice on a PPI they don't even need that's been advertised to death,” said Dr. McPherson, a professor of pharmacy at the University of Maryland, Baltimore. “You know, the purple pill, [but] it doesn't work any better than the 80 cents a day over-the-counter omeprazole [Prilosec]. We only provide a PPI if the patient is on a steroid or nonsteroidal that we are also providing.”

▸ Sancuso is a transdermal patch designed to deliver 3.1 mg of granisetron over 24 hours to prevent emesis caused by moderate- and high-risk emetogenic drugs. Approved by the Food and Drug Administration last fall, the patch is applied to the upper arm at least 24 hours before the first chemotherapy session and can be worn for up to 7 days. In clinical trials, it has been shown to have equal efficacy to 2 mg oral granisetron per day, Dr. McPherson said. Cost is $287 per patch.

The patch may be a better option for inpatient palliative care than for home-based hospice, where Haldol (haloperidol) is the mainstay for nausea, she said.

▸ Zolpidem (ZolpiMist) 5-mg and 10-mg oral spray was approved in late December 2008 for the short-term treatment of difficulties getting to sleep. The spray acts quickly, reaching therapeutic levels within the body in 15 minutes. Patients should be prepared to spend 7–8 hours in bed after receiving the drug.

▸ Metoclopramide products, which include Reglan (metoclopramide) tablets and injections, received a black box warning in February because chronic use has been linked to tardive dyskinesia. Patients at the end of life typically are treated with up to 40 mg a day of metoclopramide for less than 3 months, but caution should be used in elderly patients, especially women, and in those receiving both Reglan and Haldol because the combination doubles the risk of tardive dyskinesia, Dr. McPherson said.

▸ Tapentadol, a centrally acting analgesic with potency between those of morphine and tramadol, was approved at the end of 2008 for relief of moderate to severe acute pain in adults. Although not approved for chronic pain, it may be of use in hospice and palliative care, Dr. McPherson said. Tapentadol is under review by the Drug Enforcement Administration and is expected to be a scheduled drug.

P Tramadol is not a controlled substance at the federal level, but it may be heading that way, Dr. McPherson said. Arkansas and Kentucky have made it a schedule IV drug, and authorities in North Dakota, Ohio, and Wyoming are tracking tramadol usage through their prescription drug monitoring program as if it were controlled.

▸ Propoxyphene may be on the chopping block after two FDA advisory committees narrowly voted on Jan. 30 to recommend discontinued marketing of Darvon and Darvocet for mild to moderate pain. Propoxyphene is banned in the United Kingdom and is rarely used in Canada, but it is among the top 25 most prescribed drugs in the United States, Dr. McPherson said. She added that physicians like it because it causes less stomach upset than other opioids and can be taken by patients allergic to morphine and hydrocodone.

Propoxyphene is far from benign, Dr. McPherson said, noting that both the drug and its metabolite are cardiotoxic. Propoxyphene was a factor in 5.6% of drug-related deaths in the United States from 1981 to 1999, she said.

▸ OTC products. Emuprofen is a topically administered analgesic that contains ibuprofen and oil from the fat of the emu. It's being marketed as an anti-inflammatory and an alternative to systemic NSAID therapy for various painful conditions. Cost is about $35 for a small jar. The cream is about 10% ibuprofen. Rash and itching at the application site have been reported in up to 15% of patients.

Rain Dry Mouth Spray may be another therapeutic option for xerostomia, which affects 20% of the U.S. population and is common in people with head and neck cancer. The active ingredient is xylitol, a sugar alcohol, which can raise blood glucose if overused. Cost is about $14 for 4.5 ounces.

Tums QuickPak is a calcium carbonate powder that dissolves instantly on the tongue without the need for water and is the equivalent of two regular-strength Tums. It can be used as a daily calcium source, and for patients who can no longer swallow, she said.

Dr. McPherson disclosed that she is a consultant for Alpharma Inc.

AUSTIN, TEX. — Many new medications relevant to palliative care have come on the market recently or are about to, hospital pharmacist Mary Lynn McPherson, Pharm.D., said at the American Academy of Hospice and Palliative Medicine annual meeting.

Dr. McPherson described several new prescription drugs and over-the-counter therapies that may often be given to patients at the end of life.

Dr. McPherson commented on the following products:

▸ Dexlansoprazole (Kapidex) delayed-release capsules were approved in late January for the treatment of heartburn associated with gastroesophageal reflux disease. This R-isomer of lansoprazole (Prevacid) comes to market just as Prevacid is expected to go generic. Dexlansoprazole is the first proton pump inhibitor (PPI) with a dual delayed-release formulation, allowing doses of 30–60 mg a day, versus 15–30 mg a day for Prevacid. Costs per month are $150 for dexlansoprazole and $168 for Prevacid.

“We get the patient frequently in my practice in a hospice on a PPI they don't even need that's been advertised to death,” said Dr. McPherson, a professor of pharmacy at the University of Maryland, Baltimore. “You know, the purple pill, [but] it doesn't work any better than the 80 cents a day over-the-counter omeprazole [Prilosec]. We only provide a PPI if the patient is on a steroid or nonsteroidal that we are also providing.”

▸ Sancuso is a transdermal patch designed to deliver 3.1 mg of granisetron over 24 hours to prevent emesis caused by moderate- and high-risk emetogenic drugs. Approved by the Food and Drug Administration last fall, the patch is applied to the upper arm at least 24 hours before the first chemotherapy session and can be worn for up to 7 days. In clinical trials, it has been shown to have equal efficacy to 2 mg oral granisetron per day, Dr. McPherson said. Cost is $287 per patch.

The patch may be a better option for inpatient palliative care than for home-based hospice, where Haldol (haloperidol) is the mainstay for nausea, she said.

▸ Zolpidem (ZolpiMist) 5-mg and 10-mg oral spray was approved in late December 2008 for the short-term treatment of difficulties getting to sleep. The spray acts quickly, reaching therapeutic levels within the body in 15 minutes. Patients should be prepared to spend 7–8 hours in bed after receiving the drug.

▸ Metoclopramide products, which include Reglan (metoclopramide) tablets and injections, received a black box warning in February because chronic use has been linked to tardive dyskinesia. Patients at the end of life typically are treated with up to 40 mg a day of metoclopramide for less than 3 months, but caution should be used in elderly patients, especially women, and in those receiving both Reglan and Haldol because the combination doubles the risk of tardive dyskinesia, Dr. McPherson said.

▸ Tapentadol, a centrally acting analgesic with potency between those of morphine and tramadol, was approved at the end of 2008 for relief of moderate to severe acute pain in adults. Although not approved for chronic pain, it may be of use in hospice and palliative care, Dr. McPherson said. Tapentadol is under review by the Drug Enforcement Administration and is expected to be a scheduled drug.

P Tramadol is not a controlled substance at the federal level, but it may be heading that way, Dr. McPherson said. Arkansas and Kentucky have made it a schedule IV drug, and authorities in North Dakota, Ohio, and Wyoming are tracking tramadol usage through their prescription drug monitoring program as if it were controlled.

▸ Propoxyphene may be on the chopping block after two FDA advisory committees narrowly voted on Jan. 30 to recommend discontinued marketing of Darvon and Darvocet for mild to moderate pain. Propoxyphene is banned in the United Kingdom and is rarely used in Canada, but it is among the top 25 most prescribed drugs in the United States, Dr. McPherson said. She added that physicians like it because it causes less stomach upset than other opioids and can be taken by patients allergic to morphine and hydrocodone.

Propoxyphene is far from benign, Dr. McPherson said, noting that both the drug and its metabolite are cardiotoxic. Propoxyphene was a factor in 5.6% of drug-related deaths in the United States from 1981 to 1999, she said.

▸ OTC products. Emuprofen is a topically administered analgesic that contains ibuprofen and oil from the fat of the emu. It's being marketed as an anti-inflammatory and an alternative to systemic NSAID therapy for various painful conditions. Cost is about $35 for a small jar. The cream is about 10% ibuprofen. Rash and itching at the application site have been reported in up to 15% of patients.

Rain Dry Mouth Spray may be another therapeutic option for xerostomia, which affects 20% of the U.S. population and is common in people with head and neck cancer. The active ingredient is xylitol, a sugar alcohol, which can raise blood glucose if overused. Cost is about $14 for 4.5 ounces.

Tums QuickPak is a calcium carbonate powder that dissolves instantly on the tongue without the need for water and is the equivalent of two regular-strength Tums. It can be used as a daily calcium source, and for patients who can no longer swallow, she said.

Dr. McPherson disclosed that she is a consultant for Alpharma Inc.

AUSTIN, TEX. — Americans can get almost anything delivered to their homes, but it might not be so easy to get the doorbell to ring when you're most in need.

“There are more than 1,000 hospital-based palliative care teams in the United States, and a lot of inpatient-dedicated palliative care units and outpatient clinics, but what we don't have enough of is community-based mobile palliative care teams,” Dr. Bernie Lee said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine.

Metropolitan Jewish Health System created a home-based palliative care consultation team in September 2005 that now serves patients at home and in three nursing homes in New York City and Long Island. The Brooklyn-based program has an average census of 180 patients, with 90% residing at home.

The main focus of the team is to provide palliative care assessments and to establish patient goals in collaboration with the patient's other physicians, Dr. Lee said. Buy-in from the primary care physician is vital, but often there is no primary care physician to refer to. One-time consultations do occur, but most patients need frequent visits for pain and symptom management or psychosocial support.

Last year, 213 patients converted to hospice care after about 19 months of in-home palliative care, and 66 patients died on the program because they didn't want to go on to hospice—or couldn't, because they were still undergoing aggressive treatment. Most patients are older and are dealing with multiple comorbidities, with the primary diagnosis being cancer in 59% of patients, cardiovascular disease in 12%, and a neurologic disorder in 6%.

Palliative care differs from hospice in that it can be initiated earlier in the course of a serious or end-stage illness, can be utilized with conventional or curative care, can be accessed in conjunction with other health care providers, and does not require a 6-month prognosis for admission, said Dr. Lee, who is medical director of hospice at Metropolitan.

Referrals to the palliative care team come from a variety of sources including physician offices (55%), hospitals and oncology practices (34%), and certified home health aides (9%). As community awareness of the program increased, referrals to the palliative care team jumped from 20 referrals in its first year to more than 500 in 2008—almost as many as the health system's hospice referrals.

As the only community-based palliative care program, Metropolitan has also had to demonstrate its outcomes to HMO providers, who are slowly coming around to working with the program.

The team has only six full-time employees and reimbursement has been challenging, particularly since home-based palliative care is not regulated, Dr. Lee said. When grant funding for the program ran dry, Metropolitan had to step up and provide institutional support.

It's taken about 2 years, but the program is building other lines of revenue, primarily through Medicare and Medicaid, Dr. David Wollner, director of palliative medicine at Metropolitan, said in an interview. It is also seeking philanthropic support from within the organization and externally by applying for grants, and is developing products such as a palliative care consultation model it's selling to a large HMO in New York City, he said.

“There are many reasons why we're surviving, but the key element is having a core of committed, seasoned professionals who are willing to go the extra mile during the early years,” he said. “The other thing is that there is never [just] one element of support.”

Dr. Wollner credits the program's success to understanding and respecting their clients' ethnic and cultural diversity. “Each referral is unique,” he said. “We serve the old, the young, the rich, the homeless—and part of our success is being sensitive to the diversity of our population.”

Brian Mandel, a certified palliative care social worker with the team, said that on the same day he might visit an 89-year-old Orthodox Jew with advanced prostate cancer, a 55-year-old Catholic with colorectal cancer, and a 38-year-old Jehovah's Witness from the Caribbean with amyotrophic lateral sclerosis.

Translators are used and patient literature is translated into various languages, but Mr. Mandel agreed that cultural differences must be understood and respected. For example, Hasidic Jews will not touch the body when someone is actively dying because doing so is thought to possibly hasten death, whereas Asians believe it is bad luck to have a person die in the house, he said.

Patients and families may also lack a full understanding of the diagnosis, proposed interventions, or prognosis. They may be angry or in denial, or may not be ready to discuss end-of-life practical tasks such as choosing a funeral home or burial/cremation services.

Anne Walsh, one of three certified palliative care nurse practitioners on the team, said that patients often get overwhelmed with multiple providers in their home, and there can be a real or perceived duplication in services. Many patients with life-limiting illness receive the services of a 24-hour home health aide through Medicaid, but the registration process can be lengthy.

Ms. Walsh highlighted one of the program's success stories: a 77-year-old man with stage IV lung cancer who was undergoing daily radiation and was referred to the team for pain and symptom management as well as psychosocial support. Despite being on 10 different medications (including 10 Percocets per day), the patient rated his pain at 10 on a 10-point scale. He refused to contact relatives despite being unable to care for himself. “He was very proud of his independence,” she said.

The team changed his pain management regimen so that his pain score dropped to 3, and and worked with his insurance plan to get home care. They had him fill out a health care proxy form, and contacted his daughter. Ultimately, he moved to an inpatient hospice unit.

Ms. Walsh noted that a recent systematic literature review of 33 studies showed that although most patients with terminal cancer prefer home palliative care, most die in an institution (Oncol. Nurs. Forum 2009;36:69–77).

None of the speakers disclosed any relevant financial relationships.

“Each referral is unique,” said Dr. David Wollner, head of palliative medicine for Metropolitan Jewish Health System, New York. © NORMAN Y. LONO, 2009

AUSTIN, TEX. — Americans can get almost anything delivered to their homes, but it might not be so easy to get the doorbell to ring when you're most in need.

“There are more than 1,000 hospital-based palliative care teams in the United States, and a lot of inpatient-dedicated palliative care units and outpatient clinics, but what we don't have enough of is community-based mobile palliative care teams,” Dr. Bernie Lee said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine.

Metropolitan Jewish Health System created a home-based palliative care consultation team in September 2005 that now serves patients at home and in three nursing homes in New York City and Long Island. The Brooklyn-based program has an average census of 180 patients, with 90% residing at home.

The main focus of the team is to provide palliative care assessments and to establish patient goals in collaboration with the patient's other physicians, Dr. Lee said. Buy-in from the primary care physician is vital, but often there is no primary care physician to refer to. One-time consultations do occur, but most patients need frequent visits for pain and symptom management or psychosocial support.

Last year, 213 patients converted to hospice care after about 19 months of in-home palliative care, and 66 patients died on the program because they didn't want to go on to hospice—or couldn't, because they were still undergoing aggressive treatment. Most patients are older and are dealing with multiple comorbidities, with the primary diagnosis being cancer in 59% of patients, cardiovascular disease in 12%, and a neurologic disorder in 6%.

Palliative care differs from hospice in that it can be initiated earlier in the course of a serious or end-stage illness, can be utilized with conventional or curative care, can be accessed in conjunction with other health care providers, and does not require a 6-month prognosis for admission, said Dr. Lee, who is medical director of hospice at Metropolitan.

Referrals to the palliative care team come from a variety of sources including physician offices (55%), hospitals and oncology practices (34%), and certified home health aides (9%). As community awareness of the program increased, referrals to the palliative care team jumped from 20 referrals in its first year to more than 500 in 2008—almost as many as the health system's hospice referrals.

As the only community-based palliative care program, Metropolitan has also had to demonstrate its outcomes to HMO providers, who are slowly coming around to working with the program.

The team has only six full-time employees and reimbursement has been challenging, particularly since home-based palliative care is not regulated, Dr. Lee said. When grant funding for the program ran dry, Metropolitan had to step up and provide institutional support.

It's taken about 2 years, but the program is building other lines of revenue, primarily through Medicare and Medicaid, Dr. David Wollner, director of palliative medicine at Metropolitan, said in an interview. It is also seeking philanthropic support from within the organization and externally by applying for grants, and is developing products such as a palliative care consultation model it's selling to a large HMO in New York City, he said.

“There are many reasons why we're surviving, but the key element is having a core of committed, seasoned professionals who are willing to go the extra mile during the early years,” he said. “The other thing is that there is never [just] one element of support.”

Dr. Wollner credits the program's success to understanding and respecting their clients' ethnic and cultural diversity. “Each referral is unique,” he said. “We serve the old, the young, the rich, the homeless—and part of our success is being sensitive to the diversity of our population.”

Brian Mandel, a certified palliative care social worker with the team, said that on the same day he might visit an 89-year-old Orthodox Jew with advanced prostate cancer, a 55-year-old Catholic with colorectal cancer, and a 38-year-old Jehovah's Witness from the Caribbean with amyotrophic lateral sclerosis.

Translators are used and patient literature is translated into various languages, but Mr. Mandel agreed that cultural differences must be understood and respected. For example, Hasidic Jews will not touch the body when someone is actively dying because doing so is thought to possibly hasten death, whereas Asians believe it is bad luck to have a person die in the house, he said.

Patients and families may also lack a full understanding of the diagnosis, proposed interventions, or prognosis. They may be angry or in denial, or may not be ready to discuss end-of-life practical tasks such as choosing a funeral home or burial/cremation services.

Anne Walsh, one of three certified palliative care nurse practitioners on the team, said that patients often get overwhelmed with multiple providers in their home, and there can be a real or perceived duplication in services. Many patients with life-limiting illness receive the services of a 24-hour home health aide through Medicaid, but the registration process can be lengthy.

Ms. Walsh highlighted one of the program's success stories: a 77-year-old man with stage IV lung cancer who was undergoing daily radiation and was referred to the team for pain and symptom management as well as psychosocial support. Despite being on 10 different medications (including 10 Percocets per day), the patient rated his pain at 10 on a 10-point scale. He refused to contact relatives despite being unable to care for himself. “He was very proud of his independence,” she said.

The team changed his pain management regimen so that his pain score dropped to 3, and and worked with his insurance plan to get home care. They had him fill out a health care proxy form, and contacted his daughter. Ultimately, he moved to an inpatient hospice unit.

Ms. Walsh noted that a recent systematic literature review of 33 studies showed that although most patients with terminal cancer prefer home palliative care, most die in an institution (Oncol. Nurs. Forum 2009;36:69–77).

None of the speakers disclosed any relevant financial relationships.

“Each referral is unique,” said Dr. David Wollner, head of palliative medicine for Metropolitan Jewish Health System, New York. © NORMAN Y. LONO, 2009

AUSTIN, TEX. — Americans can get almost anything delivered to their homes, but it might not be so easy to get the doorbell to ring when you're most in need.

“There are more than 1,000 hospital-based palliative care teams in the United States, and a lot of inpatient-dedicated palliative care units and outpatient clinics, but what we don't have enough of is community-based mobile palliative care teams,” Dr. Bernie Lee said at the annual meeting of the American Academy of Hospice and Palliative Care Medicine.

Metropolitan Jewish Health System created a home-based palliative care consultation team in September 2005 that now serves patients at home and in three nursing homes in New York City and Long Island. The Brooklyn-based program has an average census of 180 patients, with 90% residing at home.

The main focus of the team is to provide palliative care assessments and to establish patient goals in collaboration with the patient's other physicians, Dr. Lee said. Buy-in from the primary care physician is vital, but often there is no primary care physician to refer to. One-time consultations do occur, but most patients need frequent visits for pain and symptom management or psychosocial support.

Last year, 213 patients converted to hospice care after about 19 months of in-home palliative care, and 66 patients died on the program because they didn't want to go on to hospice—or couldn't, because they were still undergoing aggressive treatment. Most patients are older and are dealing with multiple comorbidities, with the primary diagnosis being cancer in 59% of patients, cardiovascular disease in 12%, and a neurologic disorder in 6%.

Palliative care differs from hospice in that it can be initiated earlier in the course of a serious or end-stage illness, can be utilized with conventional or curative care, can be accessed in conjunction with other health care providers, and does not require a 6-month prognosis for admission, said Dr. Lee, who is medical director of hospice at Metropolitan.

Referrals to the palliative care team come from a variety of sources including physician offices (55%), hospitals and oncology practices (34%), and certified home health aides (9%). As community awareness of the program increased, referrals to the palliative care team jumped from 20 referrals in its first year to more than 500 in 2008—almost as many as the health system's hospice referrals.

As the only community-based palliative care program, Metropolitan has also had to demonstrate its outcomes to HMO providers, who are slowly coming around to working with the program.

The team has only six full-time employees and reimbursement has been challenging, particularly since home-based palliative care is not regulated, Dr. Lee said. When grant funding for the program ran dry, Metropolitan had to step up and provide institutional support.

It's taken about 2 years, but the program is building other lines of revenue, primarily through Medicare and Medicaid, Dr. David Wollner, director of palliative medicine at Metropolitan, said in an interview. It is also seeking philanthropic support from within the organization and externally by applying for grants, and is developing products such as a palliative care consultation model it's selling to a large HMO in New York City, he said.

“There are many reasons why we're surviving, but the key element is having a core of committed, seasoned professionals who are willing to go the extra mile during the early years,” he said. “The other thing is that there is never [just] one element of support.”

Dr. Wollner credits the program's success to understanding and respecting their clients' ethnic and cultural diversity. “Each referral is unique,” he said. “We serve the old, the young, the rich, the homeless—and part of our success is being sensitive to the diversity of our population.”

Brian Mandel, a certified palliative care social worker with the team, said that on the same day he might visit an 89-year-old Orthodox Jew with advanced prostate cancer, a 55-year-old Catholic with colorectal cancer, and a 38-year-old Jehovah's Witness from the Caribbean with amyotrophic lateral sclerosis.

Translators are used and patient literature is translated into various languages, but Mr. Mandel agreed that cultural differences must be understood and respected. For example, Hasidic Jews will not touch the body when someone is actively dying because doing so is thought to possibly hasten death, whereas Asians believe it is bad luck to have a person die in the house, he said.

Patients and families may also lack a full understanding of the diagnosis, proposed interventions, or prognosis. They may be angry or in denial, or may not be ready to discuss end-of-life practical tasks such as choosing a funeral home or burial/cremation services.

Anne Walsh, one of three certified palliative care nurse practitioners on the team, said that patients often get overwhelmed with multiple providers in their home, and there can be a real or perceived duplication in services. Many patients with life-limiting illness receive the services of a 24-hour home health aide through Medicaid, but the registration process can be lengthy.

Ms. Walsh highlighted one of the program's success stories: a 77-year-old man with stage IV lung cancer who was undergoing daily radiation and was referred to the team for pain and symptom management as well as psychosocial support. Despite being on 10 different medications (including 10 Percocets per day), the patient rated his pain at 10 on a 10-point scale. He refused to contact relatives despite being unable to care for himself. “He was very proud of his independence,” she said.

The team changed his pain management regimen so that his pain score dropped to 3, and and worked with his insurance plan to get home care. They had him fill out a health care proxy form, and contacted his daughter. Ultimately, he moved to an inpatient hospice unit.

Ms. Walsh noted that a recent systematic literature review of 33 studies showed that although most patients with terminal cancer prefer home palliative care, most die in an institution (Oncol. Nurs. Forum 2009;36:69–77).

None of the speakers disclosed any relevant financial relationships.

“Each referral is unique,” said Dr. David Wollner, head of palliative medicine for Metropolitan Jewish Health System, New York. © NORMAN Y. LONO, 2009