Heidi Splete

CHICAGO — Several genetically based periodic fever syndromes have skin signs that may help clinicians identify the syndromes on the rare occasions when they occur, Dr. Kathryn M. Edwards said at the annual meeting of the Society for Pediatric Dermatology.

Although these syndromes, called familial periodic fever syndromes, are rare, knowing something about them will "allow you to think more about how we control fever and inflammatory processes in children," noted Dr. Edwards, professor of pediatrics at Vanderbilt University, Nashville, Tenn.

"Periodic fever is a very specific diagnosis," said Dr. Edwards, an expert vaccinologist who has conducted research for the National Institutes of Health. Periodic fevers are fevers that recur at intervals lasting from a few days to a few weeks separated by totally symptom-free intervals.

"We tend to think that most often fever is due to recurrent infections," Dr. Edwards said. Consequently, many patients with periodic fever syndromes may be told that they have recurrent infections or possibly neoplasia. But a periodic fever syndrome is actually a form of autoinflammatory disorder. "Generally periodic fevers that have been present for more than 2 years are never associated with infection or malignancy," she explained.

Dr. Edwards cited one of the few studies that characterized children with periodic fever syndromes, compared with daily fevers that were associated with other illness. Overall, the 29 children with periodic fevers tended to be younger at the onset of the fever (often less than 1 year of age), had a longer duration of symptoms before they were referred for further evaluation, and had higher maximum fever temperatures, compared with 11 children with daily fevers (J. Pediatr. 1996;129:419-23).

About a quarter of the periodic fever patients had a nonspecific rash, but so did the children with daily fevers. Comorbid rash and fever isn't enough to diagnose a familial periodic fever syndrome. But pharyngitis and oral ulcers or adenopathy were seen much more often in patients with periodic fever during their intervals of fever than in those with daily fevers.

"But by and large when [children with periodic fevers] are not febrile they are totally normal, and the parents say that their kids are the healthiest on the block," Dr. Edwards said. The familial syndromes are characterized by identified genetic defects that inhibit the body's ability to control inflammation, and genetic testing is needed to confirm a diagnosis of these syndromes.

There are distinct patterns of ancestry for familial periodic fever syndromes and the genes have been circulating for generations, said Dr. Edwards. "The familial febrile syndromes are not easy to diagnose, and if you have a patient who you suspect has one of these syndromes, please contact the NIH for genotyping," she said.

Following are the familial periodic fever syndromes she described:

▸ Familial Mediterranean Fever (FMF). FMF is linked to a recessive gene known as MEFV. Many patients experience secondary amyloidosis, in which a protein buildup in various organs and tissues can impede their functions. FMF is common in Jewish families of Spanish, Portuguese, or Middle Eastern descent, but it is rare in Jewish families of European descent, Dr. Edwards noted.

Clinical features include serositis and scrotal swelling, and the periodic attacks of fever often begin in childhood. The most common dermatologic manifestation is a distinctive erysipeloid rash on the lower extremities that occurs in about 15% of children with this syndrome. Studies have shown that about half of these patients also report arthritis in one ankle, knee, or hip.

The fever attacks in FMF patients occur at regular intervals, and they usually respond to treatment within 12-72 hours. Colchicine treatment has been shown to be effective in preventing the fever episodes (and the subsequent rash), although not in treating the acute attacks of fever once they occur. "If you treat people with FMF regularly with colchicine, they don't get attacks of fever and they don't get amyloidosis, so it is important that FMF is diagnosed," Dr. Edwards said.

▸ Hyperimmunoglobulinemia D Syndrome (HIDS). HIDS has an early onset (the median age of onset is 6 months), and recurrent attacks of fever persist throughout the patient's life. Febrile attacks usually last for 3-7 days at irregular intervals ranging from 4 to 8 weeks. Clinical features include cervical adenitis, vomiting, and diarrhea. A patient with HIDS may present to a dermatologist with a maculopapular rash, with petechiae and purpura that appear during a febrile attack. Generalized lymphadenopathy and rash are very common in these patients.

Distinctive laboratory features include an elevated IgD but this elevation is not present in all HIDS patients. The gene for HIDS has been mapped to chromosome 12 and at least 8 different mutations or deletions have been seen, but the syndrome is most likely to occur in people with Dutch or French ancestry, Dr. Edwards said.

▸ Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS). Children with TRAPS may have a lifelong history of febrile episodes that last 2-3 weeks at a time, but the febrile episodes only occur 2-3 times per year.

Conjunctivitis and raised red lesions distinguish TRAPS from other familial periodic fever syndromes. One study of 25 TRAPS patients showed that 21 (84%) had erythematous patches, including both wavy and circular lesions (N. Engl. J. Med. 2001;345:1748-57). Other clinical features of TRAPS include myalgia, arthralgia, and abdominal pain.

Skin manifestations are much more common with TRAPS than with the other familial periodic fever syndromes. "Almost all of these children will have skin lesions that may persist even when the fever is gone," Dr. Edwards noted.

When a febrile episode occurs, TNF receptors are suppressed, which creates an uncontrolled inflammatory response. Consequently, TNF inhibitors can be used to treat these patients, Dr. Edwards said.

▸ Muckle-Wells Syndrome/Familial Cold Urticaria. These two syndromes are both associated with mutations of the CIAS1 gene family. Mutations in these genes lead to autoinflammatory syndromes in which large numbers of cytokines are generated, which means that amyloidosis is very frequent in these individuals.

Patients with Muckle-Wells syndrome (MWS) generally present with urticaria and progressive sensorineural loss and deafness. Because MWS is a disease of dominant genes, the parent may show signs of hearing problems, which should prompt clinicians to include MWS in the differential diagnosis of recurrent urticaria and fever.

By contrast, patients with familial cold urticaria will present not only with urticaria and wheals, but with complaints of painful joints, chills, and fever. Febrile episodes in patients with familial cold urticaria generally occur several hours after exposure to cold. Both syndromes are associated with German, English, French, and North American ancestry.

CHICAGO — Several genetically based periodic fever syndromes have skin signs that may help clinicians identify the syndromes on the rare occasions when they occur, Dr. Kathryn M. Edwards said at the annual meeting of the Society for Pediatric Dermatology.

Although these syndromes, called familial periodic fever syndromes, are rare, knowing something about them will "allow you to think more about how we control fever and inflammatory processes in children," noted Dr. Edwards, professor of pediatrics at Vanderbilt University, Nashville, Tenn.

"Periodic fever is a very specific diagnosis," said Dr. Edwards, an expert vaccinologist who has conducted research for the National Institutes of Health. Periodic fevers are fevers that recur at intervals lasting from a few days to a few weeks separated by totally symptom-free intervals.

"We tend to think that most often fever is due to recurrent infections," Dr. Edwards said. Consequently, many patients with periodic fever syndromes may be told that they have recurrent infections or possibly neoplasia. But a periodic fever syndrome is actually a form of autoinflammatory disorder. "Generally periodic fevers that have been present for more than 2 years are never associated with infection or malignancy," she explained.

Dr. Edwards cited one of the few studies that characterized children with periodic fever syndromes, compared with daily fevers that were associated with other illness. Overall, the 29 children with periodic fevers tended to be younger at the onset of the fever (often less than 1 year of age), had a longer duration of symptoms before they were referred for further evaluation, and had higher maximum fever temperatures, compared with 11 children with daily fevers (J. Pediatr. 1996;129:419-23).

About a quarter of the periodic fever patients had a nonspecific rash, but so did the children with daily fevers. Comorbid rash and fever isn't enough to diagnose a familial periodic fever syndrome. But pharyngitis and oral ulcers or adenopathy were seen much more often in patients with periodic fever during their intervals of fever than in those with daily fevers.

"But by and large when [children with periodic fevers] are not febrile they are totally normal, and the parents say that their kids are the healthiest on the block," Dr. Edwards said. The familial syndromes are characterized by identified genetic defects that inhibit the body's ability to control inflammation, and genetic testing is needed to confirm a diagnosis of these syndromes.

There are distinct patterns of ancestry for familial periodic fever syndromes and the genes have been circulating for generations, said Dr. Edwards. "The familial febrile syndromes are not easy to diagnose, and if you have a patient who you suspect has one of these syndromes, please contact the NIH for genotyping," she said.

Following are the familial periodic fever syndromes she described:

▸ Familial Mediterranean Fever (FMF). FMF is linked to a recessive gene known as MEFV. Many patients experience secondary amyloidosis, in which a protein buildup in various organs and tissues can impede their functions. FMF is common in Jewish families of Spanish, Portuguese, or Middle Eastern descent, but it is rare in Jewish families of European descent, Dr. Edwards noted.

Clinical features include serositis and scrotal swelling, and the periodic attacks of fever often begin in childhood. The most common dermatologic manifestation is a distinctive erysipeloid rash on the lower extremities that occurs in about 15% of children with this syndrome. Studies have shown that about half of these patients also report arthritis in one ankle, knee, or hip.

The fever attacks in FMF patients occur at regular intervals, and they usually respond to treatment within 12-72 hours. Colchicine treatment has been shown to be effective in preventing the fever episodes (and the subsequent rash), although not in treating the acute attacks of fever once they occur. "If you treat people with FMF regularly with colchicine, they don't get attacks of fever and they don't get amyloidosis, so it is important that FMF is diagnosed," Dr. Edwards said.

▸ Hyperimmunoglobulinemia D Syndrome (HIDS). HIDS has an early onset (the median age of onset is 6 months), and recurrent attacks of fever persist throughout the patient's life. Febrile attacks usually last for 3-7 days at irregular intervals ranging from 4 to 8 weeks. Clinical features include cervical adenitis, vomiting, and diarrhea. A patient with HIDS may present to a dermatologist with a maculopapular rash, with petechiae and purpura that appear during a febrile attack. Generalized lymphadenopathy and rash are very common in these patients.

Distinctive laboratory features include an elevated IgD but this elevation is not present in all HIDS patients. The gene for HIDS has been mapped to chromosome 12 and at least 8 different mutations or deletions have been seen, but the syndrome is most likely to occur in people with Dutch or French ancestry, Dr. Edwards said.

▸ Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS). Children with TRAPS may have a lifelong history of febrile episodes that last 2-3 weeks at a time, but the febrile episodes only occur 2-3 times per year.

Conjunctivitis and raised red lesions distinguish TRAPS from other familial periodic fever syndromes. One study of 25 TRAPS patients showed that 21 (84%) had erythematous patches, including both wavy and circular lesions (N. Engl. J. Med. 2001;345:1748-57). Other clinical features of TRAPS include myalgia, arthralgia, and abdominal pain.

Skin manifestations are much more common with TRAPS than with the other familial periodic fever syndromes. "Almost all of these children will have skin lesions that may persist even when the fever is gone," Dr. Edwards noted.

When a febrile episode occurs, TNF receptors are suppressed, which creates an uncontrolled inflammatory response. Consequently, TNF inhibitors can be used to treat these patients, Dr. Edwards said.

▸ Muckle-Wells Syndrome/Familial Cold Urticaria. These two syndromes are both associated with mutations of the CIAS1 gene family. Mutations in these genes lead to autoinflammatory syndromes in which large numbers of cytokines are generated, which means that amyloidosis is very frequent in these individuals.

Patients with Muckle-Wells syndrome (MWS) generally present with urticaria and progressive sensorineural loss and deafness. Because MWS is a disease of dominant genes, the parent may show signs of hearing problems, which should prompt clinicians to include MWS in the differential diagnosis of recurrent urticaria and fever.

By contrast, patients with familial cold urticaria will present not only with urticaria and wheals, but with complaints of painful joints, chills, and fever. Febrile episodes in patients with familial cold urticaria generally occur several hours after exposure to cold. Both syndromes are associated with German, English, French, and North American ancestry.

CHICAGO — Several genetically based periodic fever syndromes have skin signs that may help clinicians identify the syndromes on the rare occasions when they occur, Dr. Kathryn M. Edwards said at the annual meeting of the Society for Pediatric Dermatology.

Although these syndromes, called familial periodic fever syndromes, are rare, knowing something about them will "allow you to think more about how we control fever and inflammatory processes in children," noted Dr. Edwards, professor of pediatrics at Vanderbilt University, Nashville, Tenn.

"Periodic fever is a very specific diagnosis," said Dr. Edwards, an expert vaccinologist who has conducted research for the National Institutes of Health. Periodic fevers are fevers that recur at intervals lasting from a few days to a few weeks separated by totally symptom-free intervals.

"We tend to think that most often fever is due to recurrent infections," Dr. Edwards said. Consequently, many patients with periodic fever syndromes may be told that they have recurrent infections or possibly neoplasia. But a periodic fever syndrome is actually a form of autoinflammatory disorder. "Generally periodic fevers that have been present for more than 2 years are never associated with infection or malignancy," she explained.

Dr. Edwards cited one of the few studies that characterized children with periodic fever syndromes, compared with daily fevers that were associated with other illness. Overall, the 29 children with periodic fevers tended to be younger at the onset of the fever (often less than 1 year of age), had a longer duration of symptoms before they were referred for further evaluation, and had higher maximum fever temperatures, compared with 11 children with daily fevers (J. Pediatr. 1996;129:419-23).

About a quarter of the periodic fever patients had a nonspecific rash, but so did the children with daily fevers. Comorbid rash and fever isn't enough to diagnose a familial periodic fever syndrome. But pharyngitis and oral ulcers or adenopathy were seen much more often in patients with periodic fever during their intervals of fever than in those with daily fevers.

"But by and large when [children with periodic fevers] are not febrile they are totally normal, and the parents say that their kids are the healthiest on the block," Dr. Edwards said. The familial syndromes are characterized by identified genetic defects that inhibit the body's ability to control inflammation, and genetic testing is needed to confirm a diagnosis of these syndromes.

There are distinct patterns of ancestry for familial periodic fever syndromes and the genes have been circulating for generations, said Dr. Edwards. "The familial febrile syndromes are not easy to diagnose, and if you have a patient who you suspect has one of these syndromes, please contact the NIH for genotyping," she said.

Following are the familial periodic fever syndromes she described:

▸ Familial Mediterranean Fever (FMF). FMF is linked to a recessive gene known as MEFV. Many patients experience secondary amyloidosis, in which a protein buildup in various organs and tissues can impede their functions. FMF is common in Jewish families of Spanish, Portuguese, or Middle Eastern descent, but it is rare in Jewish families of European descent, Dr. Edwards noted.

Clinical features include serositis and scrotal swelling, and the periodic attacks of fever often begin in childhood. The most common dermatologic manifestation is a distinctive erysipeloid rash on the lower extremities that occurs in about 15% of children with this syndrome. Studies have shown that about half of these patients also report arthritis in one ankle, knee, or hip.

The fever attacks in FMF patients occur at regular intervals, and they usually respond to treatment within 12-72 hours. Colchicine treatment has been shown to be effective in preventing the fever episodes (and the subsequent rash), although not in treating the acute attacks of fever once they occur. "If you treat people with FMF regularly with colchicine, they don't get attacks of fever and they don't get amyloidosis, so it is important that FMF is diagnosed," Dr. Edwards said.

▸ Hyperimmunoglobulinemia D Syndrome (HIDS). HIDS has an early onset (the median age of onset is 6 months), and recurrent attacks of fever persist throughout the patient's life. Febrile attacks usually last for 3-7 days at irregular intervals ranging from 4 to 8 weeks. Clinical features include cervical adenitis, vomiting, and diarrhea. A patient with HIDS may present to a dermatologist with a maculopapular rash, with petechiae and purpura that appear during a febrile attack. Generalized lymphadenopathy and rash are very common in these patients.

Distinctive laboratory features include an elevated IgD but this elevation is not present in all HIDS patients. The gene for HIDS has been mapped to chromosome 12 and at least 8 different mutations or deletions have been seen, but the syndrome is most likely to occur in people with Dutch or French ancestry, Dr. Edwards said.

▸ Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS). Children with TRAPS may have a lifelong history of febrile episodes that last 2-3 weeks at a time, but the febrile episodes only occur 2-3 times per year.

Conjunctivitis and raised red lesions distinguish TRAPS from other familial periodic fever syndromes. One study of 25 TRAPS patients showed that 21 (84%) had erythematous patches, including both wavy and circular lesions (N. Engl. J. Med. 2001;345:1748-57). Other clinical features of TRAPS include myalgia, arthralgia, and abdominal pain.

Skin manifestations are much more common with TRAPS than with the other familial periodic fever syndromes. "Almost all of these children will have skin lesions that may persist even when the fever is gone," Dr. Edwards noted.

When a febrile episode occurs, TNF receptors are suppressed, which creates an uncontrolled inflammatory response. Consequently, TNF inhibitors can be used to treat these patients, Dr. Edwards said.

▸ Muckle-Wells Syndrome/Familial Cold Urticaria. These two syndromes are both associated with mutations of the CIAS1 gene family. Mutations in these genes lead to autoinflammatory syndromes in which large numbers of cytokines are generated, which means that amyloidosis is very frequent in these individuals.

Patients with Muckle-Wells syndrome (MWS) generally present with urticaria and progressive sensorineural loss and deafness. Because MWS is a disease of dominant genes, the parent may show signs of hearing problems, which should prompt clinicians to include MWS in the differential diagnosis of recurrent urticaria and fever.

By contrast, patients with familial cold urticaria will present not only with urticaria and wheals, but with complaints of painful joints, chills, and fever. Febrile episodes in patients with familial cold urticaria generally occur several hours after exposure to cold. Both syndromes are associated with German, English, French, and North American ancestry.

CHICAGO — Intermittent treatment with tacrolimus ointment kept atopic dermatitis under control with no need for corticosteroids in children and adolescents aged 2-15 years whose conditions had stabilized.

Because concerns persist about the long-term effects of corticosteroid use by children and teens, safe and effective alternatives for the long-term management of atopic dermatitis (AD) are needed. Because the black box warning attached to tacrolimus (Protopic) says that continuous use should be avoided, Dr. Amy S. Paller of Northwestern University, Chicago, and her colleagues designed a plan that involved applying tacrolimus ointment to the affected skin three times weekly for 40 weeks.

The treatment goal was to prevent flares in patients whose AD had stabilized. The trial of the protocol's safety and effectiveness was sponsored by Astellas Pharma US Inc., and the researchers presented their findings in a poster at the annual meeting of the Society for Pediatric Dermatology.

A total of 206 patients were randomized, but 54 discontinued the study. The most common reason for discontinuation was loss to follow-up (15 patients). Ten children dropped out because of uncontrolled rebound exacerbation of their AD, and five dropped out because of an adverse event.

Overall, the patients who received tacrolimus ointment had significantly fewer relapse days (47) than those who received a control ointment containing alclometasone (76 days). In addition, the tacrolimus patients remained stable for significantly more days before their first relapses (116 days vs. 31 days), the investigators reported.

Although there was no difference between the groups in the number of children who relapsed at least once, only 6% of the children in the tacrolimus group relapsed for up to 3 days during the study period. In the control group, 19% of the children relapsed for up to 6 days.

The most common adverse events reported by tacrolimus patients were burning and itching at the application site, which reflects results from previous safety studies. The incidence of adverse events was similar between the two groups. In general, tacrolimus ointment has a safety record similar to that of corticosteroid ointment for the initial treatment of moderate to severe AD in children, Dr. Paller and her associates noted.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Intermittent treatment with tacrolimus ointment kept atopic dermatitis under control with no need for corticosteroids in children and adolescents aged 2-15 years whose conditions had stabilized.

Because concerns persist about the long-term effects of corticosteroid use by children and teens, safe and effective alternatives for the long-term management of atopic dermatitis (AD) are needed. Because the black box warning attached to tacrolimus (Protopic) says that continuous use should be avoided, Dr. Amy S. Paller of Northwestern University, Chicago, and her colleagues designed a plan that involved applying tacrolimus ointment to the affected skin three times weekly for 40 weeks.

The treatment goal was to prevent flares in patients whose AD had stabilized. The trial of the protocol's safety and effectiveness was sponsored by Astellas Pharma US Inc., and the researchers presented their findings in a poster at the annual meeting of the Society for Pediatric Dermatology.

A total of 206 patients were randomized, but 54 discontinued the study. The most common reason for discontinuation was loss to follow-up (15 patients). Ten children dropped out because of uncontrolled rebound exacerbation of their AD, and five dropped out because of an adverse event.

Overall, the patients who received tacrolimus ointment had significantly fewer relapse days (47) than those who received a control ointment containing alclometasone (76 days). In addition, the tacrolimus patients remained stable for significantly more days before their first relapses (116 days vs. 31 days), the investigators reported.

Although there was no difference between the groups in the number of children who relapsed at least once, only 6% of the children in the tacrolimus group relapsed for up to 3 days during the study period. In the control group, 19% of the children relapsed for up to 6 days.

The most common adverse events reported by tacrolimus patients were burning and itching at the application site, which reflects results from previous safety studies. The incidence of adverse events was similar between the two groups. In general, tacrolimus ointment has a safety record similar to that of corticosteroid ointment for the initial treatment of moderate to severe AD in children, Dr. Paller and her associates noted.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Intermittent treatment with tacrolimus ointment kept atopic dermatitis under control with no need for corticosteroids in children and adolescents aged 2-15 years whose conditions had stabilized.

Because concerns persist about the long-term effects of corticosteroid use by children and teens, safe and effective alternatives for the long-term management of atopic dermatitis (AD) are needed. Because the black box warning attached to tacrolimus (Protopic) says that continuous use should be avoided, Dr. Amy S. Paller of Northwestern University, Chicago, and her colleagues designed a plan that involved applying tacrolimus ointment to the affected skin three times weekly for 40 weeks.

The treatment goal was to prevent flares in patients whose AD had stabilized. The trial of the protocol's safety and effectiveness was sponsored by Astellas Pharma US Inc., and the researchers presented their findings in a poster at the annual meeting of the Society for Pediatric Dermatology.

A total of 206 patients were randomized, but 54 discontinued the study. The most common reason for discontinuation was loss to follow-up (15 patients). Ten children dropped out because of uncontrolled rebound exacerbation of their AD, and five dropped out because of an adverse event.

Overall, the patients who received tacrolimus ointment had significantly fewer relapse days (47) than those who received a control ointment containing alclometasone (76 days). In addition, the tacrolimus patients remained stable for significantly more days before their first relapses (116 days vs. 31 days), the investigators reported.

Although there was no difference between the groups in the number of children who relapsed at least once, only 6% of the children in the tacrolimus group relapsed for up to 3 days during the study period. In the control group, 19% of the children relapsed for up to 6 days.

The most common adverse events reported by tacrolimus patients were burning and itching at the application site, which reflects results from previous safety studies. The incidence of adverse events was similar between the two groups. In general, tacrolimus ointment has a safety record similar to that of corticosteroid ointment for the initial treatment of moderate to severe AD in children, Dr. Paller and her associates noted.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — A nonsteroidal cream that contains glycyrrhetinic acid (2%) and hyaluronic acid is a safe, effective therapy for mild to moderate atopic dermatitis in infants and young children, based on data from 142 patients aged 6 months to 12 years presented at the annual meeting of the Society for Pediatric Dermatology.

The nonsteroidal cream MAS063DP, which is marketed as Atopiclair, demonstrated safety and effectiveness in adults aged 18-84 years with mild to moderate AD in a randomized, double-blind, placebo-controlled study of 218 patients (J. Drugs Dermatol. 2006;5:236-44).

To assess the safety and effectiveness of the cream in children, Dr. Mark Boguniewicz, of the National Jewish Medical and Research Center in Denver, and his colleagues randomized 72 patients to application of the test cream three times daily and 70 patients to application of a placebo cream three times a day for 43 days. The study was sponsored by Sinclair Pharmaceuticals Ltd. and Graceway Pharmaceuticals LLC.

After 8 days, 39% of the patients in the test group met criteria for "almost clear," whereas none of the placebo patients met these criteria, based on the Investigator's Global Assessment scale. After 22 days, 77% of the test group met criteria for "clear" or "almost clear," whereas none of the placebo patients met these criteria. By the end of the study at 43 days, 78% of the test patients were "clear" or "almost clear," compared with fewer than 7% of the placebo patients.

Itchiness also decreased significantly in the test group during the study period. The average scores (on a scale of 0-100 mm) on the Visual Analog Scale, which compared the same lesion at baseline and on the last day of the study, dropped from 60 mm to 13 mm in the test group and from 66 mm to 57 mm in the placebo group.

By the study's end, 81% of the patients and caregivers in the test group reported either "good improvement" or "total resolution," compared with 10% of the placebo group. Similarly, 81% of patients and caregivers in the test group said that they would "definitely" or "likely" continue to use the cream. All reported adverse events were defined as mild to moderate. The most common complaints—a burning sensation on the skin and fever—occurred with the same frequency in both the test and placebo groups (6.9% vs. 7.1%, respectively). The 26 patients who needed rescue medication at any time during the study included significantly fewer patients from the test group (6 patients) than from the placebo group (20 patients).

Atopiclair is approved by the Food and Drug Administration for marketing in the United States, a spokesperson for Sinclair Pharmaceuticals said in an interview, and "has no restrictions on age or duration of use," according to the product Web site.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — A nonsteroidal cream that contains glycyrrhetinic acid (2%) and hyaluronic acid is a safe, effective therapy for mild to moderate atopic dermatitis in infants and young children, based on data from 142 patients aged 6 months to 12 years presented at the annual meeting of the Society for Pediatric Dermatology.

The nonsteroidal cream MAS063DP, which is marketed as Atopiclair, demonstrated safety and effectiveness in adults aged 18-84 years with mild to moderate AD in a randomized, double-blind, placebo-controlled study of 218 patients (J. Drugs Dermatol. 2006;5:236-44).

To assess the safety and effectiveness of the cream in children, Dr. Mark Boguniewicz, of the National Jewish Medical and Research Center in Denver, and his colleagues randomized 72 patients to application of the test cream three times daily and 70 patients to application of a placebo cream three times a day for 43 days. The study was sponsored by Sinclair Pharmaceuticals Ltd. and Graceway Pharmaceuticals LLC.

After 8 days, 39% of the patients in the test group met criteria for "almost clear," whereas none of the placebo patients met these criteria, based on the Investigator's Global Assessment scale. After 22 days, 77% of the test group met criteria for "clear" or "almost clear," whereas none of the placebo patients met these criteria. By the end of the study at 43 days, 78% of the test patients were "clear" or "almost clear," compared with fewer than 7% of the placebo patients.

Itchiness also decreased significantly in the test group during the study period. The average scores (on a scale of 0-100 mm) on the Visual Analog Scale, which compared the same lesion at baseline and on the last day of the study, dropped from 60 mm to 13 mm in the test group and from 66 mm to 57 mm in the placebo group.

By the study's end, 81% of the patients and caregivers in the test group reported either "good improvement" or "total resolution," compared with 10% of the placebo group. Similarly, 81% of patients and caregivers in the test group said that they would "definitely" or "likely" continue to use the cream. All reported adverse events were defined as mild to moderate. The most common complaints—a burning sensation on the skin and fever—occurred with the same frequency in both the test and placebo groups (6.9% vs. 7.1%, respectively). The 26 patients who needed rescue medication at any time during the study included significantly fewer patients from the test group (6 patients) than from the placebo group (20 patients).

Atopiclair is approved by the Food and Drug Administration for marketing in the United States, a spokesperson for Sinclair Pharmaceuticals said in an interview, and "has no restrictions on age or duration of use," according to the product Web site.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — A nonsteroidal cream that contains glycyrrhetinic acid (2%) and hyaluronic acid is a safe, effective therapy for mild to moderate atopic dermatitis in infants and young children, based on data from 142 patients aged 6 months to 12 years presented at the annual meeting of the Society for Pediatric Dermatology.

The nonsteroidal cream MAS063DP, which is marketed as Atopiclair, demonstrated safety and effectiveness in adults aged 18-84 years with mild to moderate AD in a randomized, double-blind, placebo-controlled study of 218 patients (J. Drugs Dermatol. 2006;5:236-44).

To assess the safety and effectiveness of the cream in children, Dr. Mark Boguniewicz, of the National Jewish Medical and Research Center in Denver, and his colleagues randomized 72 patients to application of the test cream three times daily and 70 patients to application of a placebo cream three times a day for 43 days. The study was sponsored by Sinclair Pharmaceuticals Ltd. and Graceway Pharmaceuticals LLC.

After 8 days, 39% of the patients in the test group met criteria for "almost clear," whereas none of the placebo patients met these criteria, based on the Investigator's Global Assessment scale. After 22 days, 77% of the test group met criteria for "clear" or "almost clear," whereas none of the placebo patients met these criteria. By the end of the study at 43 days, 78% of the test patients were "clear" or "almost clear," compared with fewer than 7% of the placebo patients.

Itchiness also decreased significantly in the test group during the study period. The average scores (on a scale of 0-100 mm) on the Visual Analog Scale, which compared the same lesion at baseline and on the last day of the study, dropped from 60 mm to 13 mm in the test group and from 66 mm to 57 mm in the placebo group.

By the study's end, 81% of the patients and caregivers in the test group reported either "good improvement" or "total resolution," compared with 10% of the placebo group. Similarly, 81% of patients and caregivers in the test group said that they would "definitely" or "likely" continue to use the cream. All reported adverse events were defined as mild to moderate. The most common complaints—a burning sensation on the skin and fever—occurred with the same frequency in both the test and placebo groups (6.9% vs. 7.1%, respectively). The 26 patients who needed rescue medication at any time during the study included significantly fewer patients from the test group (6 patients) than from the placebo group (20 patients).

Atopiclair is approved by the Food and Drug Administration for marketing in the United States, a spokesperson for Sinclair Pharmaceuticals said in an interview, and "has no restrictions on age or duration of use," according to the product Web site.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Assume noncompliance when treating atopic dermatitis in teenage patients, said Dr. Jon M. Hanifin, a dermatologist at Oregon Health and Science University in Portland.

"Managing atopic dermatitis in teenagers is not for the faint of heart," said Dr. Hanifin, a specialist in atopic dermatitis who has served as a consultant for multiple pharmaceutical companies.

Dr. Hanifin shared some tips on treating atopic dermatitis (AD) in teenagers at the annual meeting of the Society for Pediatric Dermatology, including these:

▸ Keep the parents out of the room except for the start and end of the visit. "You have to get the parents out of the room to find out what's going on," he said.

▸ Ask the teens to call the office if the treatment isn't going well and encourage them to schedule their appointments.

▸ Offer psychiatric consultation. Some of these teens genuinely want some help other than their parents yelling at them.

▸ Don't shy away from systemic medications. Try methotrexate for moderate to severe cases of AD in adolescents because it is less expensive than cyclosporin, Dr. Hanifin said. He often starts teen atopic dermatitis patients with 2.5 mg of methotrexate for 4 of 7 days each week, which has been more effective than a once-weekly dose of 15 mg in many of his teen patients.

But clinicians must remember that making time for consistent AD care is rarely a priority for a busy teenager, he noted.

CHICAGO — Assume noncompliance when treating atopic dermatitis in teenage patients, said Dr. Jon M. Hanifin, a dermatologist at Oregon Health and Science University in Portland.

"Managing atopic dermatitis in teenagers is not for the faint of heart," said Dr. Hanifin, a specialist in atopic dermatitis who has served as a consultant for multiple pharmaceutical companies.

Dr. Hanifin shared some tips on treating atopic dermatitis (AD) in teenagers at the annual meeting of the Society for Pediatric Dermatology, including these:

▸ Keep the parents out of the room except for the start and end of the visit. "You have to get the parents out of the room to find out what's going on," he said.

▸ Ask the teens to call the office if the treatment isn't going well and encourage them to schedule their appointments.

▸ Offer psychiatric consultation. Some of these teens genuinely want some help other than their parents yelling at them.

▸ Don't shy away from systemic medications. Try methotrexate for moderate to severe cases of AD in adolescents because it is less expensive than cyclosporin, Dr. Hanifin said. He often starts teen atopic dermatitis patients with 2.5 mg of methotrexate for 4 of 7 days each week, which has been more effective than a once-weekly dose of 15 mg in many of his teen patients.

But clinicians must remember that making time for consistent AD care is rarely a priority for a busy teenager, he noted.

CHICAGO — Assume noncompliance when treating atopic dermatitis in teenage patients, said Dr. Jon M. Hanifin, a dermatologist at Oregon Health and Science University in Portland.

"Managing atopic dermatitis in teenagers is not for the faint of heart," said Dr. Hanifin, a specialist in atopic dermatitis who has served as a consultant for multiple pharmaceutical companies.

Dr. Hanifin shared some tips on treating atopic dermatitis (AD) in teenagers at the annual meeting of the Society for Pediatric Dermatology, including these:

▸ Keep the parents out of the room except for the start and end of the visit. "You have to get the parents out of the room to find out what's going on," he said.

▸ Ask the teens to call the office if the treatment isn't going well and encourage them to schedule their appointments.

▸ Offer psychiatric consultation. Some of these teens genuinely want some help other than their parents yelling at them.

▸ Don't shy away from systemic medications. Try methotrexate for moderate to severe cases of AD in adolescents because it is less expensive than cyclosporin, Dr. Hanifin said. He often starts teen atopic dermatitis patients with 2.5 mg of methotrexate for 4 of 7 days each week, which has been more effective than a once-weekly dose of 15 mg in many of his teen patients.

But clinicians must remember that making time for consistent AD care is rarely a priority for a busy teenager, he noted.

CHICAGO — Short-term treatment with oral corticosteroids doesn't appear to prevent infants with hemangiomas from achieving normal height, based on data from a study of 44 children with infant hemangiomas who were treated with corticosteroids for an average of 14 months.

All but two children (95%) had grown to within two standard deviations of their predicted normal heights by the time they were approximately 5 years old. The predicted normal heights were based on the average midparental height, which is a formula for predicting a child's normal adult height based on the heights of both parents. For the general population, the expected future height falls within two standard deviations of the midparental height.

"Our research question was whether short-term corticosteroids impacted long-term growth," said Dr. Perla Lansang, who presented the findings at the annual meeting of the Society for Pediatric Dermatology.

The efficacy of treating large infant hemangiomas with oral corticosteroids has been well documented, but short-term growth retardation is a common side effect and the potential for long-term growth retardation remains a concern, said Dr. Lansang, a dermatologist who conducted the study at the Hospital for Sick Children, Toronto, as part of a resident research award from the society.

The study population included 8 boys and 36 girls with hemangiomas who were treated with oral corticosteroids at the hospital between January 2000 and December 2005. Children with other metabolic conditions or those who were taking corticosteroids for other reasons were excluded. The children started taking oral corticosteroids at an average of 3 months of age, and the average dosage was 2.2 mg/kg per day. Although all the children experienced growth retardation while taking the steroids, the steepest drop off the growth curve occurred primarily during the first 3 to 4 months of treatment, Dr. Lansang noted.

The children's growth resumed after an average of 8 months of treatment, but the most rapid increase in catch-up growth occurred during the first 2 years after the children stopped taking corticosteroids. The mechanism of action for growth velocity patterns after the discontinuation of steroid use is not well understood, but by the end of the study most of the children were on track to achieve their normal height based on midparental height, Dr. Lansang said. The findings may ease clinicians' and parents' concerns about long-term growth outcomes for these children.

CHICAGO — Short-term treatment with oral corticosteroids doesn't appear to prevent infants with hemangiomas from achieving normal height, based on data from a study of 44 children with infant hemangiomas who were treated with corticosteroids for an average of 14 months.

All but two children (95%) had grown to within two standard deviations of their predicted normal heights by the time they were approximately 5 years old. The predicted normal heights were based on the average midparental height, which is a formula for predicting a child's normal adult height based on the heights of both parents. For the general population, the expected future height falls within two standard deviations of the midparental height.

"Our research question was whether short-term corticosteroids impacted long-term growth," said Dr. Perla Lansang, who presented the findings at the annual meeting of the Society for Pediatric Dermatology.

The efficacy of treating large infant hemangiomas with oral corticosteroids has been well documented, but short-term growth retardation is a common side effect and the potential for long-term growth retardation remains a concern, said Dr. Lansang, a dermatologist who conducted the study at the Hospital for Sick Children, Toronto, as part of a resident research award from the society.

The study population included 8 boys and 36 girls with hemangiomas who were treated with oral corticosteroids at the hospital between January 2000 and December 2005. Children with other metabolic conditions or those who were taking corticosteroids for other reasons were excluded. The children started taking oral corticosteroids at an average of 3 months of age, and the average dosage was 2.2 mg/kg per day. Although all the children experienced growth retardation while taking the steroids, the steepest drop off the growth curve occurred primarily during the first 3 to 4 months of treatment, Dr. Lansang noted.

The children's growth resumed after an average of 8 months of treatment, but the most rapid increase in catch-up growth occurred during the first 2 years after the children stopped taking corticosteroids. The mechanism of action for growth velocity patterns after the discontinuation of steroid use is not well understood, but by the end of the study most of the children were on track to achieve their normal height based on midparental height, Dr. Lansang said. The findings may ease clinicians' and parents' concerns about long-term growth outcomes for these children.

CHICAGO — Short-term treatment with oral corticosteroids doesn't appear to prevent infants with hemangiomas from achieving normal height, based on data from a study of 44 children with infant hemangiomas who were treated with corticosteroids for an average of 14 months.

All but two children (95%) had grown to within two standard deviations of their predicted normal heights by the time they were approximately 5 years old. The predicted normal heights were based on the average midparental height, which is a formula for predicting a child's normal adult height based on the heights of both parents. For the general population, the expected future height falls within two standard deviations of the midparental height.

"Our research question was whether short-term corticosteroids impacted long-term growth," said Dr. Perla Lansang, who presented the findings at the annual meeting of the Society for Pediatric Dermatology.

The efficacy of treating large infant hemangiomas with oral corticosteroids has been well documented, but short-term growth retardation is a common side effect and the potential for long-term growth retardation remains a concern, said Dr. Lansang, a dermatologist who conducted the study at the Hospital for Sick Children, Toronto, as part of a resident research award from the society.

The study population included 8 boys and 36 girls with hemangiomas who were treated with oral corticosteroids at the hospital between January 2000 and December 2005. Children with other metabolic conditions or those who were taking corticosteroids for other reasons were excluded. The children started taking oral corticosteroids at an average of 3 months of age, and the average dosage was 2.2 mg/kg per day. Although all the children experienced growth retardation while taking the steroids, the steepest drop off the growth curve occurred primarily during the first 3 to 4 months of treatment, Dr. Lansang noted.

The children's growth resumed after an average of 8 months of treatment, but the most rapid increase in catch-up growth occurred during the first 2 years after the children stopped taking corticosteroids. The mechanism of action for growth velocity patterns after the discontinuation of steroid use is not well understood, but by the end of the study most of the children were on track to achieve their normal height based on midparental height, Dr. Lansang said. The findings may ease clinicians' and parents' concerns about long-term growth outcomes for these children.

The Centers for Disease Control and Prevention's updated recommendations for the 2007-2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007-2008 flu season in Morbidity and Mortality Weekly Report (MMWR 2007;56RR-6:1-40). New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from all health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6-10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions.

The LAIV is currently approved only for healthy, nonpregnant individuals aged 5-49 years. The influenza vaccine for the 2007-2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for complications from influenza.

▸ Individuals in nursing homes or chronic care facilities.

Any updates to the 2007-2008 flu season vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

The Centers for Disease Control and Prevention's updated recommendations for the 2007-2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007-2008 flu season in Morbidity and Mortality Weekly Report (MMWR 2007;56RR-6:1-40). New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from all health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6-10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions.

The LAIV is currently approved only for healthy, nonpregnant individuals aged 5-49 years. The influenza vaccine for the 2007-2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for complications from influenza.

▸ Individuals in nursing homes or chronic care facilities.

Any updates to the 2007-2008 flu season vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

The Centers for Disease Control and Prevention's updated recommendations for the 2007-2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007-2008 flu season in Morbidity and Mortality Weekly Report (MMWR 2007;56RR-6:1-40). New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from all health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6-10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions.

The LAIV is currently approved only for healthy, nonpregnant individuals aged 5-49 years. The influenza vaccine for the 2007-2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for complications from influenza.

▸ Individuals in nursing homes or chronic care facilities.

Any updates to the 2007-2008 flu season vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

ATLANTA — The safety profile for Zostavax, the herpes zoster vaccine manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

"Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials," said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1 to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths.

Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available; the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines, sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of Varivax, inasmuch as each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

Merck has agreed to conduct postlicensure studies to further assess the rates of serious adverse events.

ATLANTA — The safety profile for Zostavax, the herpes zoster vaccine manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

"Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials," said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1 to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths.

Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available; the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines, sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of Varivax, inasmuch as each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

Merck has agreed to conduct postlicensure studies to further assess the rates of serious adverse events.

ATLANTA — The safety profile for Zostavax, the herpes zoster vaccine manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

"Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials," said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1 to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths.

Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available; the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines, sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of Varivax, inasmuch as each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

Merck has agreed to conduct postlicensure studies to further assess the rates of serious adverse events.

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

"Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention," said Dr. John Iskander, who presented the postlicensure data at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two surveillance mechanisms supported by the CDC.

"The data encompass the first 11 months of the U.S. experience with Gardasil," said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

"Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine," Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9-26 years (the age range used in prelicensure clinical trials).

"A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination," Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), and fever, nausea, and headache (all 11%). The most common symptoms reported with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13-16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. "Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope," Dr. Iskander noted. Many of the frequently reported adverse events, such as syncope, are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general, he said.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, and no claims alleging injuries as a result of HPV4 had been filed as of June 7, Dr. Iskander said. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006, and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline.

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

"Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention," said Dr. John Iskander, who presented the postlicensure data at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two surveillance mechanisms supported by the CDC.

"The data encompass the first 11 months of the U.S. experience with Gardasil," said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

"Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine," Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9-26 years (the age range used in prelicensure clinical trials).

"A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination," Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), and fever, nausea, and headache (all 11%). The most common symptoms reported with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13-16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. "Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope," Dr. Iskander noted. Many of the frequently reported adverse events, such as syncope, are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general, he said.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, and no claims alleging injuries as a result of HPV4 had been filed as of June 7, Dr. Iskander said. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006, and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline.

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

"Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention," said Dr. John Iskander, who presented the postlicensure data at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two surveillance mechanisms supported by the CDC.

"The data encompass the first 11 months of the U.S. experience with Gardasil," said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

"Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine," Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9-26 years (the age range used in prelicensure clinical trials).

"A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination," Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), and fever, nausea, and headache (all 11%). The most common symptoms reported with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13-16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. "Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope," Dr. Iskander noted. Many of the frequently reported adverse events, such as syncope, are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general, he said.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, and no claims alleging injuries as a result of HPV4 had been filed as of June 7, Dr. Iskander said. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006, and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline.

WASHINGTON – A 99% majority of emergency department staff said that a clinical emergency pharmacist in the ED improved the quality of patient care, based on data presented at a conference sponsored by the National Patient Safety Foundation.

Drug-related adverse events in the ED remain a significant public health problem. Reports of the success of clinical pharmacists in other hospital areas suggest that the ED-based clinical pharmacists could improve the quality of patient care; however, ED-based pharmacy programs are relatively rare, and their impact has not been well studied.

To assess the ED staff's perception of their facility's emergency clinical pharmacists, Dr. Roger J. Fairbanks and colleagues at the University of Rochester (N.Y.) surveyed a random sample of ED staff members in a tertiary care academic medical center and trauma center that included an emergency medicine residency program.

Anecdotal reports suggest that ED staff members value clinical pharmacists, but no previous studies had addressed the question, the researchers said in a poster.

They collected responses from 33 doctors and other health care providers and 42 nurses as part of a research program supported by the Agency for Healthcare Research and Quality.

A total of 96% of the respondents said that the emergency pharmacist was an integral part of the ED team. In addition, 93% of the respondents said that they regularly consulted the emergency pharmacist, and 93% reported using the pharmacist more in the ED location than in the pharmacist's previous location.

Overall, 47% of the ED staff (55% of physicians and other providers and 40% of nurses) said that immediate availability for consultation was the most valuable role of a clinical pharmacist. By contrast, slightly more nurses than doctors or other providers reported that attending medical and trauma resuscitations was the most valuable role of an emergency pharmacist (38% vs. 22%, 36% overall). Another 7% of the respondents said that the emergency pharmacist's most important role was reviewing orders, and 8% said that the emergency pharmacist's most important role was staff education.

A Web site hosted by the University of Rochester (www.emergencypharmacist.org

WASHINGTON – A 99% majority of emergency department staff said that a clinical emergency pharmacist in the ED improved the quality of patient care, based on data presented at a conference sponsored by the National Patient Safety Foundation.

Drug-related adverse events in the ED remain a significant public health problem. Reports of the success of clinical pharmacists in other hospital areas suggest that the ED-based clinical pharmacists could improve the quality of patient care; however, ED-based pharmacy programs are relatively rare, and their impact has not been well studied.

To assess the ED staff's perception of their facility's emergency clinical pharmacists, Dr. Roger J. Fairbanks and colleagues at the University of Rochester (N.Y.) surveyed a random sample of ED staff members in a tertiary care academic medical center and trauma center that included an emergency medicine residency program.

Anecdotal reports suggest that ED staff members value clinical pharmacists, but no previous studies had addressed the question, the researchers said in a poster.

They collected responses from 33 doctors and other health care providers and 42 nurses as part of a research program supported by the Agency for Healthcare Research and Quality.

A total of 96% of the respondents said that the emergency pharmacist was an integral part of the ED team. In addition, 93% of the respondents said that they regularly consulted the emergency pharmacist, and 93% reported using the pharmacist more in the ED location than in the pharmacist's previous location.

Overall, 47% of the ED staff (55% of physicians and other providers and 40% of nurses) said that immediate availability for consultation was the most valuable role of a clinical pharmacist. By contrast, slightly more nurses than doctors or other providers reported that attending medical and trauma resuscitations was the most valuable role of an emergency pharmacist (38% vs. 22%, 36% overall). Another 7% of the respondents said that the emergency pharmacist's most important role was reviewing orders, and 8% said that the emergency pharmacist's most important role was staff education.

A Web site hosted by the University of Rochester (www.emergencypharmacist.org

WASHINGTON – A 99% majority of emergency department staff said that a clinical emergency pharmacist in the ED improved the quality of patient care, based on data presented at a conference sponsored by the National Patient Safety Foundation.

Drug-related adverse events in the ED remain a significant public health problem. Reports of the success of clinical pharmacists in other hospital areas suggest that the ED-based clinical pharmacists could improve the quality of patient care; however, ED-based pharmacy programs are relatively rare, and their impact has not been well studied.

To assess the ED staff's perception of their facility's emergency clinical pharmacists, Dr. Roger J. Fairbanks and colleagues at the University of Rochester (N.Y.) surveyed a random sample of ED staff members in a tertiary care academic medical center and trauma center that included an emergency medicine residency program.

Anecdotal reports suggest that ED staff members value clinical pharmacists, but no previous studies had addressed the question, the researchers said in a poster.

They collected responses from 33 doctors and other health care providers and 42 nurses as part of a research program supported by the Agency for Healthcare Research and Quality.

A total of 96% of the respondents said that the emergency pharmacist was an integral part of the ED team. In addition, 93% of the respondents said that they regularly consulted the emergency pharmacist, and 93% reported using the pharmacist more in the ED location than in the pharmacist's previous location.

Overall, 47% of the ED staff (55% of physicians and other providers and 40% of nurses) said that immediate availability for consultation was the most valuable role of a clinical pharmacist. By contrast, slightly more nurses than doctors or other providers reported that attending medical and trauma resuscitations was the most valuable role of an emergency pharmacist (38% vs. 22%, 36% overall). Another 7% of the respondents said that the emergency pharmacist's most important role was reviewing orders, and 8% said that the emergency pharmacist's most important role was staff education.

A Web site hosted by the University of Rochester (www.emergencypharmacist.org

MINNEAPOLIS – Women with no history of sleep disorders often report sleep problems–especially difficulty falling asleep–as they undergo menopause. Their complaints were validated by a sleep study of more than 700 women presented at the annual meeting of the Associated Professional Sleep Societies.

“These data provide, for the first time, objective findings to support this common sleep complaint in postmenopausal women,” said Edward O. Bixler, Ph.D., vice chair of the sleep research division at Pennsylvania State University, Hershey.

To confirm the association between menopause and poor sleep and to seek a possible mechanism for this connection, Dr. Bixler and his colleagues conducted single-night polysomnographies on 715 women with a mean age of 49 years. Of these, 400 women were premenopausal, 120 were postmenopausal and using hormone therapy (HT), and 195 were postmenopausal but not using HT.

Women sleep as well as or better than men until they reach menopause, but sleep needs change with age, Dr. Bixler noted. With this fact in mind, the researchers used a group of 609 men who were at least 45 years old (with an average age of 49 years) as controls for the study. The average body mass index for both genders was 26.9 kg/m

The results of the single-night sleep test showed that the postmenopausal women who were not on hormone therapy took an average of 15 minutes longer to fall asleep compared with women on HT, and an average of 10 minutes longer to fall asleep compared with the men. These differences were statistically significant. The average time it took for the male controls to fall asleep was not significantly different from that of premenopausal women (a difference of 1.6 minutes) or of postmenopausal women who were taking hormone therapy (a difference of 5.6 minutes).

“What was unexpected was that we didn't find an increase in daytime sleepiness,” Dr. Bixler noted. He proposed that the lack of daytime sleepiness might be a result of the reduced need for sleep that is a natural part of aging. “As you age, you are less likely to be sleepy during the day even though you are sleeping less at night,” he said.

When the researchers looked at short-wave sleep, which is associated with the brain's ability to recharge, think, and remember, they found no differences between premenopausal women and male controls.

But postmenopausal women who didn't use HT were twice as likely to have slow-wave sleep as were male controls, and postmenopausal women who used HT were four times as likely to have slow-wave sleep as were male controls. Therefore, postmenopausal women who used HT were twice as likely to have short-wave sleep as were women who didn't use HT.

The data suggest that sleep latency is a valid symptom among menopausal women without a history of sleep disorders, especially among those who are not using HT. Based on these findings, menopausal women may be at increased risk for developing chronic insomnia that may require treatment, Dr. Bixler added.

“We would speculate that [menopausal changes] may be triggers for the onset of primary insomnia in vulnerable women,” he said.

MINNEAPOLIS – Women with no history of sleep disorders often report sleep problems–especially difficulty falling asleep–as they undergo menopause. Their complaints were validated by a sleep study of more than 700 women presented at the annual meeting of the Associated Professional Sleep Societies.

“These data provide, for the first time, objective findings to support this common sleep complaint in postmenopausal women,” said Edward O. Bixler, Ph.D., vice chair of the sleep research division at Pennsylvania State University, Hershey.

To confirm the association between menopause and poor sleep and to seek a possible mechanism for this connection, Dr. Bixler and his colleagues conducted single-night polysomnographies on 715 women with a mean age of 49 years. Of these, 400 women were premenopausal, 120 were postmenopausal and using hormone therapy (HT), and 195 were postmenopausal but not using HT.

Women sleep as well as or better than men until they reach menopause, but sleep needs change with age, Dr. Bixler noted. With this fact in mind, the researchers used a group of 609 men who were at least 45 years old (with an average age of 49 years) as controls for the study. The average body mass index for both genders was 26.9 kg/m

The results of the single-night sleep test showed that the postmenopausal women who were not on hormone therapy took an average of 15 minutes longer to fall asleep compared with women on HT, and an average of 10 minutes longer to fall asleep compared with the men. These differences were statistically significant. The average time it took for the male controls to fall asleep was not significantly different from that of premenopausal women (a difference of 1.6 minutes) or of postmenopausal women who were taking hormone therapy (a difference of 5.6 minutes).

“What was unexpected was that we didn't find an increase in daytime sleepiness,” Dr. Bixler noted. He proposed that the lack of daytime sleepiness might be a result of the reduced need for sleep that is a natural part of aging. “As you age, you are less likely to be sleepy during the day even though you are sleeping less at night,” he said.

When the researchers looked at short-wave sleep, which is associated with the brain's ability to recharge, think, and remember, they found no differences between premenopausal women and male controls.

But postmenopausal women who didn't use HT were twice as likely to have slow-wave sleep as were male controls, and postmenopausal women who used HT were four times as likely to have slow-wave sleep as were male controls. Therefore, postmenopausal women who used HT were twice as likely to have short-wave sleep as were women who didn't use HT.

The data suggest that sleep latency is a valid symptom among menopausal women without a history of sleep disorders, especially among those who are not using HT. Based on these findings, menopausal women may be at increased risk for developing chronic insomnia that may require treatment, Dr. Bixler added.

“We would speculate that [menopausal changes] may be triggers for the onset of primary insomnia in vulnerable women,” he said.

MINNEAPOLIS – Women with no history of sleep disorders often report sleep problems–especially difficulty falling asleep–as they undergo menopause. Their complaints were validated by a sleep study of more than 700 women presented at the annual meeting of the Associated Professional Sleep Societies.

“These data provide, for the first time, objective findings to support this common sleep complaint in postmenopausal women,” said Edward O. Bixler, Ph.D., vice chair of the sleep research division at Pennsylvania State University, Hershey.

To confirm the association between menopause and poor sleep and to seek a possible mechanism for this connection, Dr. Bixler and his colleagues conducted single-night polysomnographies on 715 women with a mean age of 49 years. Of these, 400 women were premenopausal, 120 were postmenopausal and using hormone therapy (HT), and 195 were postmenopausal but not using HT.

Women sleep as well as or better than men until they reach menopause, but sleep needs change with age, Dr. Bixler noted. With this fact in mind, the researchers used a group of 609 men who were at least 45 years old (with an average age of 49 years) as controls for the study. The average body mass index for both genders was 26.9 kg/m

The results of the single-night sleep test showed that the postmenopausal women who were not on hormone therapy took an average of 15 minutes longer to fall asleep compared with women on HT, and an average of 10 minutes longer to fall asleep compared with the men. These differences were statistically significant. The average time it took for the male controls to fall asleep was not significantly different from that of premenopausal women (a difference of 1.6 minutes) or of postmenopausal women who were taking hormone therapy (a difference of 5.6 minutes).

“What was unexpected was that we didn't find an increase in daytime sleepiness,” Dr. Bixler noted. He proposed that the lack of daytime sleepiness might be a result of the reduced need for sleep that is a natural part of aging. “As you age, you are less likely to be sleepy during the day even though you are sleeping less at night,” he said.

When the researchers looked at short-wave sleep, which is associated with the brain's ability to recharge, think, and remember, they found no differences between premenopausal women and male controls.

But postmenopausal women who didn't use HT were twice as likely to have slow-wave sleep as were male controls, and postmenopausal women who used HT were four times as likely to have slow-wave sleep as were male controls. Therefore, postmenopausal women who used HT were twice as likely to have short-wave sleep as were women who didn't use HT.

The data suggest that sleep latency is a valid symptom among menopausal women without a history of sleep disorders, especially among those who are not using HT. Based on these findings, menopausal women may be at increased risk for developing chronic insomnia that may require treatment, Dr. Bixler added.

“We would speculate that [menopausal changes] may be triggers for the onset of primary insomnia in vulnerable women,” he said.