Sherry Boschert

Major Finding: The rate of reactive nonstress tests in pregnant women with chronic hypertension was not significantly different in 76 patients treated with labetalol (84%), compared with 36 treated with methyldopa (81%).

Data Source: Retrospective study of all pregnant women treated for chronic hypertension at one institution from January 2003 to September 2007.

Disclosures: None was reported.

SAN FRANCISCO — Results of nonstress tests in 112 pregnant women being treated for chronic hypertension from January 2003 to September 2007 did not differ significantly in patients on labetalol, compared with those on methyldopa, results of a retrospective study found.

“Attending physicians should feel comfortable using labetalol or methyldopa for pregnant patients with hypertension. Those medications have no effect on the baby,” Dr. Ramata Niang said in an interview at her prize-winning poster presentation at the meeting.

She and her associates had hypothesized that treatment with labetalol would increase the rate of nonreactive nonstress tests, but found no evidence of that.

Nonstress tests were reactive in 84% of 76 patients on labetalol and in 81% of 36 patients on methyldopa, a difference that was not statistically significant, reported Dr. Niang, an ob.gyn. at the University of Illinois at Chicago.

Among U.S. pregnant women, 10% have hypertension, which has been associated with an increased risk for perinatal morbidity and mortality. Traditionally, methyldopa has been used to treat hypertension during pregnancy, but in recent years more physicians have begun using beta-blockers or other medications. Labetalol is both a selective alpha-blocker and a nonselective beta-blocker that decreases systemic vascular resistance without changing maternal cardiac output.

Investigators used the average of nonstress test results for each patient to categorize results as reactive or nonreactive. The study started with charts on 188 women treated for hypertension during pregnancy and excluded women with multiple-gestation pregnancies, other antihypertensive treatment, or incomplete prenatal testing charts, to focus on the remaining 112 patients.

There were no significant differences between the two treatment groups in maternal age (29 years for women on labetalol and 31 years for those on methyldopa), gestational age at delivery (37 and 38 weeks), birth weight (2,823 g and 3,048 g), or the rate of preeclampsia (less than 1% in both groups).

Black patients made up 74% of the labetalol group and 53% of the methyldopa group, while white patients made up 12% and 23% of the two groups, respectively; Hispanics made up 6% of the labetalol group and 15% of the methyldopa group, with other races/ethnicities accounting for the remainder.

'Attending physicians should feel comfortable using labetalol or methyldopa.'

Source DR. NIANG

Major Finding: The rate of reactive nonstress tests in pregnant women with chronic hypertension was not significantly different in 76 patients treated with labetalol (84%), compared with 36 treated with methyldopa (81%).

Data Source: Retrospective study of all pregnant women treated for chronic hypertension at one institution from January 2003 to September 2007.

Disclosures: None was reported.

SAN FRANCISCO — Results of nonstress tests in 112 pregnant women being treated for chronic hypertension from January 2003 to September 2007 did not differ significantly in patients on labetalol, compared with those on methyldopa, results of a retrospective study found.

“Attending physicians should feel comfortable using labetalol or methyldopa for pregnant patients with hypertension. Those medications have no effect on the baby,” Dr. Ramata Niang said in an interview at her prize-winning poster presentation at the meeting.

She and her associates had hypothesized that treatment with labetalol would increase the rate of nonreactive nonstress tests, but found no evidence of that.

Nonstress tests were reactive in 84% of 76 patients on labetalol and in 81% of 36 patients on methyldopa, a difference that was not statistically significant, reported Dr. Niang, an ob.gyn. at the University of Illinois at Chicago.

Among U.S. pregnant women, 10% have hypertension, which has been associated with an increased risk for perinatal morbidity and mortality. Traditionally, methyldopa has been used to treat hypertension during pregnancy, but in recent years more physicians have begun using beta-blockers or other medications. Labetalol is both a selective alpha-blocker and a nonselective beta-blocker that decreases systemic vascular resistance without changing maternal cardiac output.

Investigators used the average of nonstress test results for each patient to categorize results as reactive or nonreactive. The study started with charts on 188 women treated for hypertension during pregnancy and excluded women with multiple-gestation pregnancies, other antihypertensive treatment, or incomplete prenatal testing charts, to focus on the remaining 112 patients.

There were no significant differences between the two treatment groups in maternal age (29 years for women on labetalol and 31 years for those on methyldopa), gestational age at delivery (37 and 38 weeks), birth weight (2,823 g and 3,048 g), or the rate of preeclampsia (less than 1% in both groups).

Black patients made up 74% of the labetalol group and 53% of the methyldopa group, while white patients made up 12% and 23% of the two groups, respectively; Hispanics made up 6% of the labetalol group and 15% of the methyldopa group, with other races/ethnicities accounting for the remainder.

'Attending physicians should feel comfortable using labetalol or methyldopa.'

Source DR. NIANG

Major Finding: The rate of reactive nonstress tests in pregnant women with chronic hypertension was not significantly different in 76 patients treated with labetalol (84%), compared with 36 treated with methyldopa (81%).

Data Source: Retrospective study of all pregnant women treated for chronic hypertension at one institution from January 2003 to September 2007.

Disclosures: None was reported.

SAN FRANCISCO — Results of nonstress tests in 112 pregnant women being treated for chronic hypertension from January 2003 to September 2007 did not differ significantly in patients on labetalol, compared with those on methyldopa, results of a retrospective study found.

“Attending physicians should feel comfortable using labetalol or methyldopa for pregnant patients with hypertension. Those medications have no effect on the baby,” Dr. Ramata Niang said in an interview at her prize-winning poster presentation at the meeting.

She and her associates had hypothesized that treatment with labetalol would increase the rate of nonreactive nonstress tests, but found no evidence of that.

Nonstress tests were reactive in 84% of 76 patients on labetalol and in 81% of 36 patients on methyldopa, a difference that was not statistically significant, reported Dr. Niang, an ob.gyn. at the University of Illinois at Chicago.

Among U.S. pregnant women, 10% have hypertension, which has been associated with an increased risk for perinatal morbidity and mortality. Traditionally, methyldopa has been used to treat hypertension during pregnancy, but in recent years more physicians have begun using beta-blockers or other medications. Labetalol is both a selective alpha-blocker and a nonselective beta-blocker that decreases systemic vascular resistance without changing maternal cardiac output.

Investigators used the average of nonstress test results for each patient to categorize results as reactive or nonreactive. The study started with charts on 188 women treated for hypertension during pregnancy and excluded women with multiple-gestation pregnancies, other antihypertensive treatment, or incomplete prenatal testing charts, to focus on the remaining 112 patients.

There were no significant differences between the two treatment groups in maternal age (29 years for women on labetalol and 31 years for those on methyldopa), gestational age at delivery (37 and 38 weeks), birth weight (2,823 g and 3,048 g), or the rate of preeclampsia (less than 1% in both groups).

Black patients made up 74% of the labetalol group and 53% of the methyldopa group, while white patients made up 12% and 23% of the two groups, respectively; Hispanics made up 6% of the labetalol group and 15% of the methyldopa group, with other races/ethnicities accounting for the remainder.

'Attending physicians should feel comfortable using labetalol or methyldopa.'

Source DR. NIANG

LOS ANGELES — The experimental drug telcagepant for acute migraine therapy appears to be tolerated by patients with stable coronary artery disease and to be consistently effective in various subgroups of patients, according to several analyses of randomized, double-blind, placebo- or active-controlled studies.

Previous studies have shown that telcagepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, is effective in acute treatment of migraine (Neurology 2009;73:970-7; Lancet 2008;372:2115-23; Neurology 2008;70:1304-12).

The new analyses were led by employees of Merck, which is developing telcagepant and which funded the studies. Merck also had been developing the drug for migraine prophylaxis, but stopped those trials when some patients taking twice-daily doses for 3 months developed elevated liver enzyme levels, a company spokeswoman said in an e-mail interview after the meeting. Following discussions with the Food and Drug Administration at the end of 2009, Merck is conducting an additional safety study this year before regulators consider the drug further—a 6-month study of 4,500 females with menstrually associated migraine who will take 140 mg of telcagepant or placebo once daily for 7 consecutive days on a monthly basis.

No Cardiovascular Problems Noted

A double-blind, crossover study randomized patients with migraines and stable coronary artery disease to one of two treatment groups. Patients in the first group treated up to 12 moderate to severe migraines with telcagepant in a 280-mg tablet plus a 300-mg capsule during a 6-week period, then treated 12 more migraines in the next 6-week period with acetaminophen 1,000 mg. Patients in the second group got placebo for the first moderate to severe migraine attack, then acetaminophen for up to 11 more migraines in the first 6-week period; in the second 6 weeks, up to 12 migraines were treated with the telcagepant regimen.

Final data were available to analyze safety in 184 patients and efficacy in 105 patients.

Adverse events were reported within 48 hours of treatment by 17 of 98 patients on telcagepant (17%) and 9 of 86 patients on acetaminophen (10%), reported Dr. Tony Ho, senior director of clinical research at Merck Research Laboratories, North Wales, Penn., and his associates. Drug-related adverse events were reported by eight patients (8%) on telcagepant and four (5%) on acetaminophen. No patients stopped treatment because of adverse events.

Three serious vascular events—two reports of chest pain after telcagepant and one report of renal artery stenosis after acetaminophen—were sent for adjudication by a blinded independent expert committee. The committee declared all to be non-thromboembolic events, and each occurred longer than 48 hours after migraine treatment. No patients had transaminase elevations three times the upper limit of normal or higher.

The study did not find significant differences in efficacy, perhaps because of the small number of patients, the investigators suggested. No pain was reported in 13 (25%) of 52 patients 2 hours after taking telcagepant, compared with 10 (19%) of 53 patients on placebo.

The apparent lack of a significant risk of using telcagepant in patients with coronary artery disease is a huge plus. The drug could be an alternative for patients who can't take triptans, Dr. Leslie Kelman, medical director of the private practice Headache Center of Atlanta, said in an interview. He was not involved in the telcagepant studies.

Efficacy in Migraine Subgroups

A pooled analysis of single-attack data from three randomized, double-blind, placebo-controlled studies involving a total of 3,829 patients compared the efficacy of 140 mg or 150 mg of telcagepant, 280 mg or 300 mg of the drug, or placebo.

For migraine with aura, 21% of 230 patients on the lower doses of telcagepant and 28% of 222 patients on the higher doses were pain-free 2 hours after treatment, compared with 10% of 233 patients on placebo. For migraine without aura, 21% of 1,020 patients on lower-dose telcagepant, 24% of 1,019 patients on higher doses, and 10% of 996 patients on placebo were pain-free after 2 hours. Rates were higher for pain relief at 2 hours but similar between aura and no-aura subgroups.

For menstrually associated migraines, 52% of 216 patients on lower doses and 56% of 209 on higher doses were pain-free after 2 hours, compared with 29% of 221 patients on placebo. For non-menstrual migraines, 54% of 571 patients on lower doses, 60% of 557 on higher doses, and 33% of 557 on placebo were pain-free at 2 hours, Dr. Ho and his associates reported.

Among patients who reported that previous migraine treatment with a triptan was of “no use,” 62% of 343 patients on the lower doses of telcagepant and 56% of 339 on the higher doses were pain-free after 2 hours, compared with 39% of 346 patients on placebo.

The footprint of efficacy of telcagepant may be a little different from the footprint of efficacy of the triptans, which would be a great thing if it were so, said Dr. Kelman, who has been a speaker for Merck and other companies that manufacture migraine drugs.

Among patients who reported that previous treatment with a non-steroidal anti-inflammatory drug was of “no use,” 53% of 443 patients on lower-dose telcagepant, 57% of 418 on higher doses, and 26% of 484 patients on placebo were free of pain after 2 hours.

Response After Prior Opioid Use

A post-hoc analysis of data from a randomized, double-blind placebo-controlled trial suggests that patients with or without a prior response to opioid treatment for migraines might respond similarly to telcagepant. Among 111 patients who reported at least a 75% response to prior opioid therapy, 64% of those who took telcagepant 140 mg for a migraine attack and 69% on 280 mg were pain-free after 2 hours, compared with 54% on placebo.

Among 243 patients who reported less than a 75% response to prior opioid therapy, telcagepant brought pain relief at 2 hours in 54% of patients who received 140 mg and in 55% of patients on 280 mg, compared with 26% of patients on placebo. Among 1,163 patients with no history of opioid use for migraine, freedom from pain at 2 hours was reported by 60% on 140-mg telcagepant, 56% on 280-mg telcagepant, and 32% on placebo, Dr. Ho and his associates reported.

Signals of Low Abuse Potential

Thirty-six healthy recreational polydrug users were randomized in a double-blind, six-period crossover study to evaluate their liking for single doses of placebo or telcagepant 280 mg, 560 mg, 1,120 mg, or 1.5 mg or 3 mg of alprazolam as a positive control known to have abuse potential. Patient ratings on a Drug Liking visual analogue scale showed no significant differences between telcagepant and placebo, while alprazolam was ranked significantly higher than telcagepant or placebo, reported Rebecca Blanchard, Ph.D., also of Merck Research Laboratories, and her associates.

Efficacy Unchanged in Combination

Combining telcagepant with ibuprofen or acetaminophen did not significantly change efficacy in a pilot randomized, double-blind, placebo-controlled study, reported Dr. David J. Hewitt of Merck Research Laboratories and his associates.

Pain freedom at 2 hours was reported by 35% of 145 patients who took telcagepant 280 mg plus ibuprofen 400 mg, 38% of 133 patients who took the same telcagepant dose plus acetaminophen 1,000 mg, 31% who got telcagepant alone, and 11% who received placebo.

The footprint of efficacy of telcagepant may be a little different from the footprint of efficacy of the triptans.

Source DR. KELMAN

LOS ANGELES — The experimental drug telcagepant for acute migraine therapy appears to be tolerated by patients with stable coronary artery disease and to be consistently effective in various subgroups of patients, according to several analyses of randomized, double-blind, placebo- or active-controlled studies.

Previous studies have shown that telcagepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, is effective in acute treatment of migraine (Neurology 2009;73:970-7; Lancet 2008;372:2115-23; Neurology 2008;70:1304-12).

The new analyses were led by employees of Merck, which is developing telcagepant and which funded the studies. Merck also had been developing the drug for migraine prophylaxis, but stopped those trials when some patients taking twice-daily doses for 3 months developed elevated liver enzyme levels, a company spokeswoman said in an e-mail interview after the meeting. Following discussions with the Food and Drug Administration at the end of 2009, Merck is conducting an additional safety study this year before regulators consider the drug further—a 6-month study of 4,500 females with menstrually associated migraine who will take 140 mg of telcagepant or placebo once daily for 7 consecutive days on a monthly basis.

No Cardiovascular Problems Noted

A double-blind, crossover study randomized patients with migraines and stable coronary artery disease to one of two treatment groups. Patients in the first group treated up to 12 moderate to severe migraines with telcagepant in a 280-mg tablet plus a 300-mg capsule during a 6-week period, then treated 12 more migraines in the next 6-week period with acetaminophen 1,000 mg. Patients in the second group got placebo for the first moderate to severe migraine attack, then acetaminophen for up to 11 more migraines in the first 6-week period; in the second 6 weeks, up to 12 migraines were treated with the telcagepant regimen.

Final data were available to analyze safety in 184 patients and efficacy in 105 patients.

Adverse events were reported within 48 hours of treatment by 17 of 98 patients on telcagepant (17%) and 9 of 86 patients on acetaminophen (10%), reported Dr. Tony Ho, senior director of clinical research at Merck Research Laboratories, North Wales, Penn., and his associates. Drug-related adverse events were reported by eight patients (8%) on telcagepant and four (5%) on acetaminophen. No patients stopped treatment because of adverse events.

Three serious vascular events—two reports of chest pain after telcagepant and one report of renal artery stenosis after acetaminophen—were sent for adjudication by a blinded independent expert committee. The committee declared all to be non-thromboembolic events, and each occurred longer than 48 hours after migraine treatment. No patients had transaminase elevations three times the upper limit of normal or higher.

The study did not find significant differences in efficacy, perhaps because of the small number of patients, the investigators suggested. No pain was reported in 13 (25%) of 52 patients 2 hours after taking telcagepant, compared with 10 (19%) of 53 patients on placebo.

The apparent lack of a significant risk of using telcagepant in patients with coronary artery disease is a huge plus. The drug could be an alternative for patients who can't take triptans, Dr. Leslie Kelman, medical director of the private practice Headache Center of Atlanta, said in an interview. He was not involved in the telcagepant studies.

Efficacy in Migraine Subgroups

A pooled analysis of single-attack data from three randomized, double-blind, placebo-controlled studies involving a total of 3,829 patients compared the efficacy of 140 mg or 150 mg of telcagepant, 280 mg or 300 mg of the drug, or placebo.

For migraine with aura, 21% of 230 patients on the lower doses of telcagepant and 28% of 222 patients on the higher doses were pain-free 2 hours after treatment, compared with 10% of 233 patients on placebo. For migraine without aura, 21% of 1,020 patients on lower-dose telcagepant, 24% of 1,019 patients on higher doses, and 10% of 996 patients on placebo were pain-free after 2 hours. Rates were higher for pain relief at 2 hours but similar between aura and no-aura subgroups.

For menstrually associated migraines, 52% of 216 patients on lower doses and 56% of 209 on higher doses were pain-free after 2 hours, compared with 29% of 221 patients on placebo. For non-menstrual migraines, 54% of 571 patients on lower doses, 60% of 557 on higher doses, and 33% of 557 on placebo were pain-free at 2 hours, Dr. Ho and his associates reported.

Among patients who reported that previous migraine treatment with a triptan was of “no use,” 62% of 343 patients on the lower doses of telcagepant and 56% of 339 on the higher doses were pain-free after 2 hours, compared with 39% of 346 patients on placebo.

The footprint of efficacy of telcagepant may be a little different from the footprint of efficacy of the triptans, which would be a great thing if it were so, said Dr. Kelman, who has been a speaker for Merck and other companies that manufacture migraine drugs.

Among patients who reported that previous treatment with a non-steroidal anti-inflammatory drug was of “no use,” 53% of 443 patients on lower-dose telcagepant, 57% of 418 on higher doses, and 26% of 484 patients on placebo were free of pain after 2 hours.

Response After Prior Opioid Use

A post-hoc analysis of data from a randomized, double-blind placebo-controlled trial suggests that patients with or without a prior response to opioid treatment for migraines might respond similarly to telcagepant. Among 111 patients who reported at least a 75% response to prior opioid therapy, 64% of those who took telcagepant 140 mg for a migraine attack and 69% on 280 mg were pain-free after 2 hours, compared with 54% on placebo.

Among 243 patients who reported less than a 75% response to prior opioid therapy, telcagepant brought pain relief at 2 hours in 54% of patients who received 140 mg and in 55% of patients on 280 mg, compared with 26% of patients on placebo. Among 1,163 patients with no history of opioid use for migraine, freedom from pain at 2 hours was reported by 60% on 140-mg telcagepant, 56% on 280-mg telcagepant, and 32% on placebo, Dr. Ho and his associates reported.

Signals of Low Abuse Potential

Thirty-six healthy recreational polydrug users were randomized in a double-blind, six-period crossover study to evaluate their liking for single doses of placebo or telcagepant 280 mg, 560 mg, 1,120 mg, or 1.5 mg or 3 mg of alprazolam as a positive control known to have abuse potential. Patient ratings on a Drug Liking visual analogue scale showed no significant differences between telcagepant and placebo, while alprazolam was ranked significantly higher than telcagepant or placebo, reported Rebecca Blanchard, Ph.D., also of Merck Research Laboratories, and her associates.

Efficacy Unchanged in Combination

Combining telcagepant with ibuprofen or acetaminophen did not significantly change efficacy in a pilot randomized, double-blind, placebo-controlled study, reported Dr. David J. Hewitt of Merck Research Laboratories and his associates.

Pain freedom at 2 hours was reported by 35% of 145 patients who took telcagepant 280 mg plus ibuprofen 400 mg, 38% of 133 patients who took the same telcagepant dose plus acetaminophen 1,000 mg, 31% who got telcagepant alone, and 11% who received placebo.

The footprint of efficacy of telcagepant may be a little different from the footprint of efficacy of the triptans.

Source DR. KELMAN

LOS ANGELES — The experimental drug telcagepant for acute migraine therapy appears to be tolerated by patients with stable coronary artery disease and to be consistently effective in various subgroups of patients, according to several analyses of randomized, double-blind, placebo- or active-controlled studies.

Previous studies have shown that telcagepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, is effective in acute treatment of migraine (Neurology 2009;73:970-7; Lancet 2008;372:2115-23; Neurology 2008;70:1304-12).

The new analyses were led by employees of Merck, which is developing telcagepant and which funded the studies. Merck also had been developing the drug for migraine prophylaxis, but stopped those trials when some patients taking twice-daily doses for 3 months developed elevated liver enzyme levels, a company spokeswoman said in an e-mail interview after the meeting. Following discussions with the Food and Drug Administration at the end of 2009, Merck is conducting an additional safety study this year before regulators consider the drug further—a 6-month study of 4,500 females with menstrually associated migraine who will take 140 mg of telcagepant or placebo once daily for 7 consecutive days on a monthly basis.

No Cardiovascular Problems Noted

A double-blind, crossover study randomized patients with migraines and stable coronary artery disease to one of two treatment groups. Patients in the first group treated up to 12 moderate to severe migraines with telcagepant in a 280-mg tablet plus a 300-mg capsule during a 6-week period, then treated 12 more migraines in the next 6-week period with acetaminophen 1,000 mg. Patients in the second group got placebo for the first moderate to severe migraine attack, then acetaminophen for up to 11 more migraines in the first 6-week period; in the second 6 weeks, up to 12 migraines were treated with the telcagepant regimen.

Final data were available to analyze safety in 184 patients and efficacy in 105 patients.

Adverse events were reported within 48 hours of treatment by 17 of 98 patients on telcagepant (17%) and 9 of 86 patients on acetaminophen (10%), reported Dr. Tony Ho, senior director of clinical research at Merck Research Laboratories, North Wales, Penn., and his associates. Drug-related adverse events were reported by eight patients (8%) on telcagepant and four (5%) on acetaminophen. No patients stopped treatment because of adverse events.

Three serious vascular events—two reports of chest pain after telcagepant and one report of renal artery stenosis after acetaminophen—were sent for adjudication by a blinded independent expert committee. The committee declared all to be non-thromboembolic events, and each occurred longer than 48 hours after migraine treatment. No patients had transaminase elevations three times the upper limit of normal or higher.

The study did not find significant differences in efficacy, perhaps because of the small number of patients, the investigators suggested. No pain was reported in 13 (25%) of 52 patients 2 hours after taking telcagepant, compared with 10 (19%) of 53 patients on placebo.

The apparent lack of a significant risk of using telcagepant in patients with coronary artery disease is a huge plus. The drug could be an alternative for patients who can't take triptans, Dr. Leslie Kelman, medical director of the private practice Headache Center of Atlanta, said in an interview. He was not involved in the telcagepant studies.

Efficacy in Migraine Subgroups

A pooled analysis of single-attack data from three randomized, double-blind, placebo-controlled studies involving a total of 3,829 patients compared the efficacy of 140 mg or 150 mg of telcagepant, 280 mg or 300 mg of the drug, or placebo.

For migraine with aura, 21% of 230 patients on the lower doses of telcagepant and 28% of 222 patients on the higher doses were pain-free 2 hours after treatment, compared with 10% of 233 patients on placebo. For migraine without aura, 21% of 1,020 patients on lower-dose telcagepant, 24% of 1,019 patients on higher doses, and 10% of 996 patients on placebo were pain-free after 2 hours. Rates were higher for pain relief at 2 hours but similar between aura and no-aura subgroups.

For menstrually associated migraines, 52% of 216 patients on lower doses and 56% of 209 on higher doses were pain-free after 2 hours, compared with 29% of 221 patients on placebo. For non-menstrual migraines, 54% of 571 patients on lower doses, 60% of 557 on higher doses, and 33% of 557 on placebo were pain-free at 2 hours, Dr. Ho and his associates reported.

Among patients who reported that previous migraine treatment with a triptan was of “no use,” 62% of 343 patients on the lower doses of telcagepant and 56% of 339 on the higher doses were pain-free after 2 hours, compared with 39% of 346 patients on placebo.

The footprint of efficacy of telcagepant may be a little different from the footprint of efficacy of the triptans, which would be a great thing if it were so, said Dr. Kelman, who has been a speaker for Merck and other companies that manufacture migraine drugs.

Among patients who reported that previous treatment with a non-steroidal anti-inflammatory drug was of “no use,” 53% of 443 patients on lower-dose telcagepant, 57% of 418 on higher doses, and 26% of 484 patients on placebo were free of pain after 2 hours.

Response After Prior Opioid Use

A post-hoc analysis of data from a randomized, double-blind placebo-controlled trial suggests that patients with or without a prior response to opioid treatment for migraines might respond similarly to telcagepant. Among 111 patients who reported at least a 75% response to prior opioid therapy, 64% of those who took telcagepant 140 mg for a migraine attack and 69% on 280 mg were pain-free after 2 hours, compared with 54% on placebo.

Among 243 patients who reported less than a 75% response to prior opioid therapy, telcagepant brought pain relief at 2 hours in 54% of patients who received 140 mg and in 55% of patients on 280 mg, compared with 26% of patients on placebo. Among 1,163 patients with no history of opioid use for migraine, freedom from pain at 2 hours was reported by 60% on 140-mg telcagepant, 56% on 280-mg telcagepant, and 32% on placebo, Dr. Ho and his associates reported.

Signals of Low Abuse Potential

Thirty-six healthy recreational polydrug users were randomized in a double-blind, six-period crossover study to evaluate their liking for single doses of placebo or telcagepant 280 mg, 560 mg, 1,120 mg, or 1.5 mg or 3 mg of alprazolam as a positive control known to have abuse potential. Patient ratings on a Drug Liking visual analogue scale showed no significant differences between telcagepant and placebo, while alprazolam was ranked significantly higher than telcagepant or placebo, reported Rebecca Blanchard, Ph.D., also of Merck Research Laboratories, and her associates.

Efficacy Unchanged in Combination

Combining telcagepant with ibuprofen or acetaminophen did not significantly change efficacy in a pilot randomized, double-blind, placebo-controlled study, reported Dr. David J. Hewitt of Merck Research Laboratories and his associates.

Pain freedom at 2 hours was reported by 35% of 145 patients who took telcagepant 280 mg plus ibuprofen 400 mg, 38% of 133 patients who took the same telcagepant dose plus acetaminophen 1,000 mg, 31% who got telcagepant alone, and 11% who received placebo.

The footprint of efficacy of telcagepant may be a little different from the footprint of efficacy of the triptans.

Source DR. KELMAN

Major Finding: Adults with migraines who had cardiovascular risk factors were 39%-83% more likely to report abuse or neglect during childhood, compared with migraineurs without cardiovascular problems.

Data Source: Cross-sectional study of 1,348 adult migraine patients at 11 U.S. and Canadian headache centers.

Disclosures: Dr. Tietjen has received research grants from GlaxoSmithKline, and consulting fees and honoraria from MAP Pharmaceuticals.

LOS ANGELES — Adults with migraines who also had cardiovascular risk factors were 39%-83% more likely to report having been abused or neglected as children compared with migraineurs without cardiovascular problems in a study of 1,348 patients.

In addition, a linear relationship was found between the risk of stroke/transient ischemic attack (TIA), myocardial infarction, or both and the total number of types of abuse reported by patients, Dr. Gretchen E. Tietjen reported at the meeting.

“This certainly suggests that childhood maltreatment may adversely influence cardiovascular status—both disease and risk factors—in adulthood,” she said.

Previous studies have identified associations between childhood maltreatment and adult morbidities, including cardiovascular disease. But this is the first study to look at those associations in migraineurs.

Headache specialists determined the migraine diagnosis and attack frequency for the patients at 11 U.S. and Canadian headache centers. Patients reported whether they had been told by a physician that they have cardiovascular disease, specific cardiovascular risk factors, or other comorbidities while completing a self-administered electronic questionnaire, which included the Childhood Trauma Questionnaire to identify childhood maltreatment.

One or more cardiovascular risk factors was reported by 71% of patients, including hypertension, hyperlipidemia, obesity, obstructive sleep apnea, or ever having smoked. A small percentage of patients reported a history of stroke or TIA (5%) or prior MI (4%).

The questionnaire asked about physical, sexual, or emotional abuse and about physical or emotional neglect. Migraineurs with cardiovascular disease were more likely to report childhood abuse rather than less-severe neglect, compared with migraineurs without cardiovascular disease, reported Dr. Tietjen and her associates in the American Headache Society's Women's Issues Research Consortium.

Patients with one or more cardiovascular risk factors said they had experienced more types of abuse as children compared with migraineurs without cardiovascular risk factors, said Dr. Tietjen, professor and chair of neurology at the University of Toledo, Ohio. (See chart.)

Because the analysis was controlled for age, race, gender, income, education, and each of the other individual risk factors, “those are pretty significant differences,” she said. “I certainly think that abuse is related to migraine in some way, but how well it fits in” remains to be determined in future studies of better databases.

“I'd really like to look at young people—people that are in the 18-to-24 range, where maybe migraine is all they have, but if they have a history of abuse it may mean that they are predisposed to develop some of these other conditions,” Dr. Tietjen said in an interview at the meeting. Cognitive-behavioral therapy might help these young people change their response to stressful stimuli.

A separate analysis of the study's data identified three constellations of comorbidities in migraineurs with distinct demographic, headache, and psychosocial profiles, Dr. Tietjen reported in a separate presentation at the meeting.

One group of 231 patients reported a relative absence of comorbid conditions. Another 669 patients fit into a group of “pain conditions,” including irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, interstitial cystitis, uterine fibroids, and arthritis. The remaining 448 patients were grouped in “metabolic and psychiatric conditions,” including hypertension, diabetes, hyperlipidemia, depression, and anxiety.

Compared with the group without comorbidities, the pain and metabolic/psychiatric groups were older, more likely to be white, had more headaches per month, were more likely to have chronic migraine, and had higher disability scores on the six-item Headache Impact Test. The two comorbidity groups were associated with a doubling or tripling in risk for childhood maltreatment, especially emotional abuse, in an adjusted logistic regression analysis, Dr. Tietjen said.

Patients in the pain or metabolic/psychiatric comorbidity groups were three times as likely as the no-comorbidity group to report childhood emotional abuse or emotional neglect and twice as likely to report physical or sexual abuse. Reports of physical neglect were twice as likely in the pain group and three times as likely in the metabolic/psychiatric group, compared with the control group.

Future studies of general populations with headache should carefully classify them by headache criteria, Dr. Tietjen and her associates suggested. A better understanding of the link between adverse childhood experiences and migraine might improve understanding of the pathophysiology and lead to better therapies, she said.

'This certainly suggests that childhood maltreatment may adversely influence cardiovascular status.'

Source DR. TIETJEN

Source Elsevier Global Medical News

Major Finding: Adults with migraines who had cardiovascular risk factors were 39%-83% more likely to report abuse or neglect during childhood, compared with migraineurs without cardiovascular problems.

Data Source: Cross-sectional study of 1,348 adult migraine patients at 11 U.S. and Canadian headache centers.

Disclosures: Dr. Tietjen has received research grants from GlaxoSmithKline, and consulting fees and honoraria from MAP Pharmaceuticals.

LOS ANGELES — Adults with migraines who also had cardiovascular risk factors were 39%-83% more likely to report having been abused or neglected as children compared with migraineurs without cardiovascular problems in a study of 1,348 patients.

In addition, a linear relationship was found between the risk of stroke/transient ischemic attack (TIA), myocardial infarction, or both and the total number of types of abuse reported by patients, Dr. Gretchen E. Tietjen reported at the meeting.

“This certainly suggests that childhood maltreatment may adversely influence cardiovascular status—both disease and risk factors—in adulthood,” she said.

Previous studies have identified associations between childhood maltreatment and adult morbidities, including cardiovascular disease. But this is the first study to look at those associations in migraineurs.

Headache specialists determined the migraine diagnosis and attack frequency for the patients at 11 U.S. and Canadian headache centers. Patients reported whether they had been told by a physician that they have cardiovascular disease, specific cardiovascular risk factors, or other comorbidities while completing a self-administered electronic questionnaire, which included the Childhood Trauma Questionnaire to identify childhood maltreatment.

One or more cardiovascular risk factors was reported by 71% of patients, including hypertension, hyperlipidemia, obesity, obstructive sleep apnea, or ever having smoked. A small percentage of patients reported a history of stroke or TIA (5%) or prior MI (4%).

The questionnaire asked about physical, sexual, or emotional abuse and about physical or emotional neglect. Migraineurs with cardiovascular disease were more likely to report childhood abuse rather than less-severe neglect, compared with migraineurs without cardiovascular disease, reported Dr. Tietjen and her associates in the American Headache Society's Women's Issues Research Consortium.

Patients with one or more cardiovascular risk factors said they had experienced more types of abuse as children compared with migraineurs without cardiovascular risk factors, said Dr. Tietjen, professor and chair of neurology at the University of Toledo, Ohio. (See chart.)

Because the analysis was controlled for age, race, gender, income, education, and each of the other individual risk factors, “those are pretty significant differences,” she said. “I certainly think that abuse is related to migraine in some way, but how well it fits in” remains to be determined in future studies of better databases.

“I'd really like to look at young people—people that are in the 18-to-24 range, where maybe migraine is all they have, but if they have a history of abuse it may mean that they are predisposed to develop some of these other conditions,” Dr. Tietjen said in an interview at the meeting. Cognitive-behavioral therapy might help these young people change their response to stressful stimuli.

A separate analysis of the study's data identified three constellations of comorbidities in migraineurs with distinct demographic, headache, and psychosocial profiles, Dr. Tietjen reported in a separate presentation at the meeting.

One group of 231 patients reported a relative absence of comorbid conditions. Another 669 patients fit into a group of “pain conditions,” including irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, interstitial cystitis, uterine fibroids, and arthritis. The remaining 448 patients were grouped in “metabolic and psychiatric conditions,” including hypertension, diabetes, hyperlipidemia, depression, and anxiety.

Compared with the group without comorbidities, the pain and metabolic/psychiatric groups were older, more likely to be white, had more headaches per month, were more likely to have chronic migraine, and had higher disability scores on the six-item Headache Impact Test. The two comorbidity groups were associated with a doubling or tripling in risk for childhood maltreatment, especially emotional abuse, in an adjusted logistic regression analysis, Dr. Tietjen said.

Patients in the pain or metabolic/psychiatric comorbidity groups were three times as likely as the no-comorbidity group to report childhood emotional abuse or emotional neglect and twice as likely to report physical or sexual abuse. Reports of physical neglect were twice as likely in the pain group and three times as likely in the metabolic/psychiatric group, compared with the control group.

Future studies of general populations with headache should carefully classify them by headache criteria, Dr. Tietjen and her associates suggested. A better understanding of the link between adverse childhood experiences and migraine might improve understanding of the pathophysiology and lead to better therapies, she said.

'This certainly suggests that childhood maltreatment may adversely influence cardiovascular status.'

Source DR. TIETJEN

Source Elsevier Global Medical News

Major Finding: Adults with migraines who had cardiovascular risk factors were 39%-83% more likely to report abuse or neglect during childhood, compared with migraineurs without cardiovascular problems.

Data Source: Cross-sectional study of 1,348 adult migraine patients at 11 U.S. and Canadian headache centers.

Disclosures: Dr. Tietjen has received research grants from GlaxoSmithKline, and consulting fees and honoraria from MAP Pharmaceuticals.

LOS ANGELES — Adults with migraines who also had cardiovascular risk factors were 39%-83% more likely to report having been abused or neglected as children compared with migraineurs without cardiovascular problems in a study of 1,348 patients.

In addition, a linear relationship was found between the risk of stroke/transient ischemic attack (TIA), myocardial infarction, or both and the total number of types of abuse reported by patients, Dr. Gretchen E. Tietjen reported at the meeting.

“This certainly suggests that childhood maltreatment may adversely influence cardiovascular status—both disease and risk factors—in adulthood,” she said.

Previous studies have identified associations between childhood maltreatment and adult morbidities, including cardiovascular disease. But this is the first study to look at those associations in migraineurs.

Headache specialists determined the migraine diagnosis and attack frequency for the patients at 11 U.S. and Canadian headache centers. Patients reported whether they had been told by a physician that they have cardiovascular disease, specific cardiovascular risk factors, or other comorbidities while completing a self-administered electronic questionnaire, which included the Childhood Trauma Questionnaire to identify childhood maltreatment.

One or more cardiovascular risk factors was reported by 71% of patients, including hypertension, hyperlipidemia, obesity, obstructive sleep apnea, or ever having smoked. A small percentage of patients reported a history of stroke or TIA (5%) or prior MI (4%).

The questionnaire asked about physical, sexual, or emotional abuse and about physical or emotional neglect. Migraineurs with cardiovascular disease were more likely to report childhood abuse rather than less-severe neglect, compared with migraineurs without cardiovascular disease, reported Dr. Tietjen and her associates in the American Headache Society's Women's Issues Research Consortium.

Patients with one or more cardiovascular risk factors said they had experienced more types of abuse as children compared with migraineurs without cardiovascular risk factors, said Dr. Tietjen, professor and chair of neurology at the University of Toledo, Ohio. (See chart.)

Because the analysis was controlled for age, race, gender, income, education, and each of the other individual risk factors, “those are pretty significant differences,” she said. “I certainly think that abuse is related to migraine in some way, but how well it fits in” remains to be determined in future studies of better databases.

“I'd really like to look at young people—people that are in the 18-to-24 range, where maybe migraine is all they have, but if they have a history of abuse it may mean that they are predisposed to develop some of these other conditions,” Dr. Tietjen said in an interview at the meeting. Cognitive-behavioral therapy might help these young people change their response to stressful stimuli.

A separate analysis of the study's data identified three constellations of comorbidities in migraineurs with distinct demographic, headache, and psychosocial profiles, Dr. Tietjen reported in a separate presentation at the meeting.

One group of 231 patients reported a relative absence of comorbid conditions. Another 669 patients fit into a group of “pain conditions,” including irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, interstitial cystitis, uterine fibroids, and arthritis. The remaining 448 patients were grouped in “metabolic and psychiatric conditions,” including hypertension, diabetes, hyperlipidemia, depression, and anxiety.

Compared with the group without comorbidities, the pain and metabolic/psychiatric groups were older, more likely to be white, had more headaches per month, were more likely to have chronic migraine, and had higher disability scores on the six-item Headache Impact Test. The two comorbidity groups were associated with a doubling or tripling in risk for childhood maltreatment, especially emotional abuse, in an adjusted logistic regression analysis, Dr. Tietjen said.

Patients in the pain or metabolic/psychiatric comorbidity groups were three times as likely as the no-comorbidity group to report childhood emotional abuse or emotional neglect and twice as likely to report physical or sexual abuse. Reports of physical neglect were twice as likely in the pain group and three times as likely in the metabolic/psychiatric group, compared with the control group.

Future studies of general populations with headache should carefully classify them by headache criteria, Dr. Tietjen and her associates suggested. A better understanding of the link between adverse childhood experiences and migraine might improve understanding of the pathophysiology and lead to better therapies, she said.

'This certainly suggests that childhood maltreatment may adversely influence cardiovascular status.'

Source DR. TIETJEN

Source Elsevier Global Medical News

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing the adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

In 2009, the Centers for Medicare and Medicaid Services began offering to Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009–2010. The bonus for early adopters of e-prescribing will drop to 1% in 2011–2012 and to 0.5% in 2013, Rachelle F. Spiro said.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, but on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas.

“We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said.

Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component, or to stand-alone e-prescribing systems if they come from an entity on the CMS list of qualified EHR vendors, she advised.

She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said.

Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs, and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same HITECH (Health Information Technology for Economic and Clinical Health) Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing.

“Actually, those incentives are a lot better” than Medicare incentives, she said.

Physicians who work in long-term care settings and who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro.

Disclosures: Ms. Spiro reported having no relevant conflicts of interest.

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing the adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

In 2009, the Centers for Medicare and Medicaid Services began offering to Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009–2010. The bonus for early adopters of e-prescribing will drop to 1% in 2011–2012 and to 0.5% in 2013, Rachelle F. Spiro said.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, but on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas.

“We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said.

Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component, or to stand-alone e-prescribing systems if they come from an entity on the CMS list of qualified EHR vendors, she advised.

She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said.

Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs, and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same HITECH (Health Information Technology for Economic and Clinical Health) Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing.

“Actually, those incentives are a lot better” than Medicare incentives, she said.

Physicians who work in long-term care settings and who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro.

Disclosures: Ms. Spiro reported having no relevant conflicts of interest.

LONG BEACH, CALIF. — The inability to prescribe controlled substances electronically is slowing the adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

In 2009, the Centers for Medicare and Medicaid Services began offering to Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009–2010. The bonus for early adopters of e-prescribing will drop to 1% in 2011–2012 and to 0.5% in 2013, Rachelle F. Spiro said.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, but on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas.

“We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said.

Only a few days after she spoke, the agency published a proposed rule to that effect.

A pilot program for e-prescribing of controlled substances was conducted in Massachusetts, but not in long-term care settings.

Physicians do not need to preregister for the CMS e-prescribing incentive program and do not need to participate in the Physician Quality Reporting Initiative to participate, Ms. Spiro said.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available on the CMS Web site at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component, or to stand-alone e-prescribing systems if they come from an entity on the CMS list of qualified EHR vendors, she advised.

She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said.

Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs, and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same HITECH (Health Information Technology for Economic and Clinical Health) Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing.

“Actually, those incentives are a lot better” than Medicare incentives, she said.

Physicians who work in long-term care settings and who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro.

Disclosures: Ms. Spiro reported having no relevant conflicts of interest.

LONG BEACH, CALIF. – The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009-2010. The bonus for early adopters of e-prescribing drops to 1% in 2011-2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available from CMS at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro. She reported having no relevant conflicts of interest.

LONG BEACH, CALIF. – The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009-2010. The bonus for early adopters of e-prescribing drops to 1% in 2011-2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available from CMS at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro. She reported having no relevant conflicts of interest.

LONG BEACH, CALIF. – The inability to prescribe controlled substances electronically is slowing adoption of electronic prescribing, but financial incentives could make it worthwhile for physicians who see patients covered by Medicare to start “e-prescribing” now if they can, a consultant said.

The Centers for Medicare and Medicaid Services in 2009 began offering Medicare physicians, nurse practitioners, and physician assistants a 2% bonus in payments for participation in its electronic prescribing incentives program for 2009-2010. The bonus for early adopters of e-prescribing drops to 1% in 2011-2012 and 0.5% in 2013, Rachelle F. Spiro said at the annual meeting of the American Medical Directors Association.

The early e-prescriber incentives were extended to long-term care settings this year. The incentives are not yet available for non-Medicare e-prescribers.

“Here's the hard part,” she added: Physicians who do not successfully adopt e-prescribing by 2012 will see a 1% reduction in Medicare payments for that year, a 1.5% drop for 2013, and a 2% reduction for 2014 and each subsequent year. The Department of Health and Human Services may exempt physicians with hardships, on a case-by-case basis only.

The Drug Enforcement Agency (DEA) does not allow controlled substances to be electronically prescribed, however, which “has hindered the adoption of electronic prescribing,” said Ms. Spiro, a pharmacist and consultant based in Las Vegas. “We've been told that CMS will be working with the DEA to put out final rules for electronic prescribing” of controlled substances, she said. Only a few days after she spoke, the agency published a proposed rule to that effect.

Instructions and examples of how to submit claims under the e-prescribing incentive program are available from CMS at www.cms.hhs.gov/ERxIncentiveqnetsupport@sdps.org

Physicians can use their facility's electronic health records (EHR) system to send a prescription and to document it in the medical record, then bill for the incentive in much the same way they already handle billing.

Or physicians can turn to certified practice management systems that have an e-prescribing component or to stand-alone e-prescribing systems, if they come from an entity on the CMS list of qualified EHR vendors, she advised. She warned that prescriptions from these two types of systems generally go directly to the pharmacy and not necessarily to the nursing home, “so you're going to have to work out some other mechanism to get that communication to the facility.”

To file claims in the e-prescribing incentives program, report the e-prescribing numerator G-code G8553 to denote that at least one prescription was created during the patient encounter that was transmitted using a qualified e-prescribing system. Report the G-code on the same claim as the denominator billing code for the same beneficiary and the same date of service. Submit the e-prescribing G-code with a line-item charge of zero dollars ($0.00).

Denominator billing codes for e-prescribing include codes for services in nursing facilities (99304-99310 and 99315-99316), home visits (99341-99350), and others including domiciliary codes (99324-99328, 99334-99337, and 99346).

As of 2011, Medicare will be offering incentives for physicians in hospitals and ambulatory settings to switch all of their records to EHR, but these incentives won't be available to long-term and post–acute care settings until 2013, Ms. Spiro said. Physicians must choose between the Medicare e-prescribing incentives and complete EHR incentives programs and cannot participate in both (because presumably the EHR would include an e-prescribing component).

However, the same Health Information Technology for Economic and Clinical Health Act that established the EHR incentives included a provision for state Medicaid programs to incentivize early adoption of e-prescribing. “Actually, those incentives are a lot better” than Medicare incentives, she said. Physicians in long-term care settings who see patients covered by Medicare and Medicaid may want to participate in both e-prescribing early-adopter programs rather than wait for the 2013 EHR incentives under Medicare.

For the long-term care setting, that's “probably a better value,” said Ms. Spiro. She reported having no relevant conflicts of interest.

Major Finding: Starting marijuana use in the preteen years instead of the teen years was associated with a significantly greater likelihood of current posttraumatic stress disorder (16% vs. 6%) and a history of suicide attempts (32% vs. 19%).

Data Source: Retrospective study of 139 teenagers in residential treatment for substance dependence disorder.

Disclosures: Dr. Mahfoud said the investigators have no pertinent conflicts of interest. The study was funded by the National Institute on Alcohol Abuse and Alcoholism and the John Templeton Foundation.

SAN FRANCISCO – Substance-dependent young people who started smoking marijuana in their preteen years entered treatment with greater impairments than did those who started using marijuana as teenagers in a study of 136 patients in residential treatment.

Among the cohort of 14- to 18-year-olds, 57 (42%) began smoking marijuana before age 13 and 79 (58%) started marijuana use during their teenage years. Those whose marijuana use started before age 13 were more likely to have comorbid posttraumatic stress disorder (PTSD)–9 patients (16%) vs. 5 patients (6%)–and to have a history of suicide attempts–18 patients(32%) vs. 15 patients (19%)–at the time they entered treatment for substance dependence.

Preteen initiation of marijuana use also was associated with a history of past traffic violations, in four patients (7%) compared with one patient (1%), Dr. Youssef Mahfoud and his associates reported at the annual conference of the American Society of Addiction Medicine.

Marijuana dependence was significantly more likely in preteen users than in later users–54 patients (95%) vs. 61 (77%). Hallucinogen dependence also was more common in those who started marijuana as preteens: 25 patients (44%) vs. 21 patients (27%), said Dr. Mahfoud, a fellow in the psychiatry department of Case Western Reserve University, Cleveland.

In general, those young people who began using marijuana as preteens were more likely to be dependent on more than one substance.

The preteen marijuana users smoked more cigarettes per day (11 per patient) compared with the teen marijuana group (8 per patient) and were younger when they entered treatment (15.9 years vs. 16.5 years).

The associations between preteen marijuana use and more problems at the time youths enter treatment are not necessarily causal, Dr. Mahfoud noted. Preteens with PTSD, for example, might be using marijuana to self-medicate.

The increased rate of suicide attempts in preteen marijuana users might be attributable to a potentially increased rate of comorbid depression, but the study did not assess depression rates, he added.

“Marijuana, the most commonly used illicit substance in the United States, is perceived by many youths to be harmless,” but it might pose special risks for preteen users, whose adolescent brain growth peaks around age 12, he said.

Previous studies have shown that marijuana use commonly is associated with increased rates of anxiety, legal problems, dropping out of school, and cognitive impairment with long-term use, he noted.

Dr. Mahfoud and his associates retrospectively studied data from semistructured interviews of patients, medical charts, and reports by the youths, parents, and clinicians. Because these were treatment-seeking patients, the findings might not be representative of other populations.

The cohort was 66% white. Preteen marijuana use was more common among Hispanics (8 patients, or 14%) than among non-Hispanics (2 patients, or 3%) and among patients with less-educated parents.

Overall, 57% of patients had a parent with a substance dependence disorder, and 57% came from single-parent households.

The study is the largest of substance-dependent young people that contained a generally gender-balanced cohort–47% male, 53% female, Dr. Mahfoud said.

Future research should investigate the way in which preteen marijuana might interfere with the brain's major growth spurt at age 12, Dr. Mahfoud suggested.

Marijuana might pose special risks for preteen users, whose adolescent brain growth peaks around age 12.

Source DR. MAHFOUD

Major Finding: Starting marijuana use in the preteen years instead of the teen years was associated with a significantly greater likelihood of current posttraumatic stress disorder (16% vs. 6%) and a history of suicide attempts (32% vs. 19%).

Data Source: Retrospective study of 139 teenagers in residential treatment for substance dependence disorder.

Disclosures: Dr. Mahfoud said the investigators have no pertinent conflicts of interest. The study was funded by the National Institute on Alcohol Abuse and Alcoholism and the John Templeton Foundation.

SAN FRANCISCO – Substance-dependent young people who started smoking marijuana in their preteen years entered treatment with greater impairments than did those who started using marijuana as teenagers in a study of 136 patients in residential treatment.

Among the cohort of 14- to 18-year-olds, 57 (42%) began smoking marijuana before age 13 and 79 (58%) started marijuana use during their teenage years. Those whose marijuana use started before age 13 were more likely to have comorbid posttraumatic stress disorder (PTSD)–9 patients (16%) vs. 5 patients (6%)–and to have a history of suicide attempts–18 patients(32%) vs. 15 patients (19%)–at the time they entered treatment for substance dependence.

Preteen initiation of marijuana use also was associated with a history of past traffic violations, in four patients (7%) compared with one patient (1%), Dr. Youssef Mahfoud and his associates reported at the annual conference of the American Society of Addiction Medicine.

Marijuana dependence was significantly more likely in preteen users than in later users–54 patients (95%) vs. 61 (77%). Hallucinogen dependence also was more common in those who started marijuana as preteens: 25 patients (44%) vs. 21 patients (27%), said Dr. Mahfoud, a fellow in the psychiatry department of Case Western Reserve University, Cleveland.

In general, those young people who began using marijuana as preteens were more likely to be dependent on more than one substance.

The preteen marijuana users smoked more cigarettes per day (11 per patient) compared with the teen marijuana group (8 per patient) and were younger when they entered treatment (15.9 years vs. 16.5 years).

The associations between preteen marijuana use and more problems at the time youths enter treatment are not necessarily causal, Dr. Mahfoud noted. Preteens with PTSD, for example, might be using marijuana to self-medicate.

The increased rate of suicide attempts in preteen marijuana users might be attributable to a potentially increased rate of comorbid depression, but the study did not assess depression rates, he added.

“Marijuana, the most commonly used illicit substance in the United States, is perceived by many youths to be harmless,” but it might pose special risks for preteen users, whose adolescent brain growth peaks around age 12, he said.

Previous studies have shown that marijuana use commonly is associated with increased rates of anxiety, legal problems, dropping out of school, and cognitive impairment with long-term use, he noted.

Dr. Mahfoud and his associates retrospectively studied data from semistructured interviews of patients, medical charts, and reports by the youths, parents, and clinicians. Because these were treatment-seeking patients, the findings might not be representative of other populations.

The cohort was 66% white. Preteen marijuana use was more common among Hispanics (8 patients, or 14%) than among non-Hispanics (2 patients, or 3%) and among patients with less-educated parents.

Overall, 57% of patients had a parent with a substance dependence disorder, and 57% came from single-parent households.

The study is the largest of substance-dependent young people that contained a generally gender-balanced cohort–47% male, 53% female, Dr. Mahfoud said.

Future research should investigate the way in which preteen marijuana might interfere with the brain's major growth spurt at age 12, Dr. Mahfoud suggested.

Marijuana might pose special risks for preteen users, whose adolescent brain growth peaks around age 12.

Source DR. MAHFOUD

Major Finding: Starting marijuana use in the preteen years instead of the teen years was associated with a significantly greater likelihood of current posttraumatic stress disorder (16% vs. 6%) and a history of suicide attempts (32% vs. 19%).

Data Source: Retrospective study of 139 teenagers in residential treatment for substance dependence disorder.

Disclosures: Dr. Mahfoud said the investigators have no pertinent conflicts of interest. The study was funded by the National Institute on Alcohol Abuse and Alcoholism and the John Templeton Foundation.

SAN FRANCISCO – Substance-dependent young people who started smoking marijuana in their preteen years entered treatment with greater impairments than did those who started using marijuana as teenagers in a study of 136 patients in residential treatment.

Among the cohort of 14- to 18-year-olds, 57 (42%) began smoking marijuana before age 13 and 79 (58%) started marijuana use during their teenage years. Those whose marijuana use started before age 13 were more likely to have comorbid posttraumatic stress disorder (PTSD)–9 patients (16%) vs. 5 patients (6%)–and to have a history of suicide attempts–18 patients(32%) vs. 15 patients (19%)–at the time they entered treatment for substance dependence.

Preteen initiation of marijuana use also was associated with a history of past traffic violations, in four patients (7%) compared with one patient (1%), Dr. Youssef Mahfoud and his associates reported at the annual conference of the American Society of Addiction Medicine.

Marijuana dependence was significantly more likely in preteen users than in later users–54 patients (95%) vs. 61 (77%). Hallucinogen dependence also was more common in those who started marijuana as preteens: 25 patients (44%) vs. 21 patients (27%), said Dr. Mahfoud, a fellow in the psychiatry department of Case Western Reserve University, Cleveland.

In general, those young people who began using marijuana as preteens were more likely to be dependent on more than one substance.

The preteen marijuana users smoked more cigarettes per day (11 per patient) compared with the teen marijuana group (8 per patient) and were younger when they entered treatment (15.9 years vs. 16.5 years).

The associations between preteen marijuana use and more problems at the time youths enter treatment are not necessarily causal, Dr. Mahfoud noted. Preteens with PTSD, for example, might be using marijuana to self-medicate.

The increased rate of suicide attempts in preteen marijuana users might be attributable to a potentially increased rate of comorbid depression, but the study did not assess depression rates, he added.

“Marijuana, the most commonly used illicit substance in the United States, is perceived by many youths to be harmless,” but it might pose special risks for preteen users, whose adolescent brain growth peaks around age 12, he said.

Previous studies have shown that marijuana use commonly is associated with increased rates of anxiety, legal problems, dropping out of school, and cognitive impairment with long-term use, he noted.

Dr. Mahfoud and his associates retrospectively studied data from semistructured interviews of patients, medical charts, and reports by the youths, parents, and clinicians. Because these were treatment-seeking patients, the findings might not be representative of other populations.

The cohort was 66% white. Preteen marijuana use was more common among Hispanics (8 patients, or 14%) than among non-Hispanics (2 patients, or 3%) and among patients with less-educated parents.

Overall, 57% of patients had a parent with a substance dependence disorder, and 57% came from single-parent households.

The study is the largest of substance-dependent young people that contained a generally gender-balanced cohort–47% male, 53% female, Dr. Mahfoud said.

Future research should investigate the way in which preteen marijuana might interfere with the brain's major growth spurt at age 12, Dr. Mahfoud suggested.

Marijuana might pose special risks for preteen users, whose adolescent brain growth peaks around age 12.

Source DR. MAHFOUD

SAN FRANCISCO — Fifty years after the introduction of oral contraceptives, physicians are looking to long-acting removable contraceptives to provide the next leap forward in preventing unintended pregnancy.

Three themes emerged in interviews with multiple physicians who gave separate presentations on contraception in sessions at the meeting.

First, nothing in the future of contraception is likely to match the revolutionary impact of oral contraception. Second, the great advances in contraception over the past half-decade still are accompanied by an unacceptably high rate of unintended pregnancies. And third, when asked to imagine what contraception might look like 50 years from now, most physicians looked to greater use of long-acting removable contraception (LARC) such as intrauterine devices (IUDs) or implants.

Long-acting removable contraception is the wave of the future, said Dr. Sarah Prager of the University of Washington, Seattle. sheeir advantage is that once the devices are inserted, they don't require patient participation in contraception, which has been one of the major stumbling blocks in contraceptive failures.

Not that physicians haven't kept trying new ways to get patients to remember to take their daily contraceptive pill. One prize-winning poster at the meeting reported on a randomized study that sent reminders by text messages on cell phones. It didn't help, reported Dr. Melody Y. Hou of Boston University and her associates. Among the 82 women, objective pill counts showed an average of five pills missed per cycle in both groups randomized to get or not get text messages.

The next 50 years probably will see improvements in long-acting removable contraceptives, Dr. Prager added. “Our longest-acting LARC method only lasts for 10-12 years,” she noted.

Dr. Joseph Anthony Ogburn of the University of New Mexico, Albuquerque, shared the same vision for the future. Approximately half of U.S. pregnancies are unintended, giving the United States the worst unintended pregnancy rate among developed countries, he noted.

Only about 1%-2% of U.S. women on contraception use an IUD, and less than 1% have a contraceptive implant. “If we could increase those numbers significantly, I think we could have a dramatic impact on the unintended pregnancy rate,” he said. Advances in the next 50 years probably will entail tweaking existing long-acting removable contraceptives to make them more acceptable.

Dr. Pouru Bhiwandi was more enthusiastic. “It's a very, very exciting time for all of contraception,” said Dr. Bhiwandi, an ob.gyn. in Raleigh, N.C., and an international consultant in women's health. “We have so many choices today, which we've never had before.”

Since the first oral contraceptive was approved in 1960, women's options grew with approval of more than 40 birth control pills and the development of other forms of hormonal contraception in transdermal patches, the vaginal ring, implants, and intrauterine devices (IUDs).

Modifications in dosing since the first oral contraceptives, which contained nearly four times the amount of estrogen and nearly 10 times the amount of progestin as today's formulations, have made the Pill safer and more acceptable, as has the development of newer estrogens and progesterones, she added. Newer regimens mean women no longer have to bleed while on hormonal contraception.

On the horizon are “exciting possibilities” for new products in barrier contraception that are both spermicidal and microbicidal to prevent sexually transmitted infections, plus “a whole range of new IUDs, a 1-year vaginal ring with a new progestin, and other products,” Dr. Bhiwandi said.

The U.S. should emulate Europe, where longer-acting methods of birth control, including IUDs and contraceptives are much more prevalent, said Dr. Andrew Kaunitz, professor of ob.gyn. at the University of Florida, Jacksonville.

Although U.S. clinical trials report a failure rate of 1%-2% with oral contraceptive use, in “typical practice” it's much higher, Dr. Kaunitz said—around nine women per 100 couples annually have unintended pregnancies on the Pill. “That's too high,” he said.

Dr. Bliss Kaneshiro of the University of Hawaii, Honolulu, noted that long-acting contraceptive devices are expensive and not always covered by insurance. “One of the big challenges, I think, is cost,” she said. “Our challenge for the next 50 years is improving access to those good contraceptive methods.”

Dr. David Plourd of the Naval Medical Center, San Diego, said he hopes to see more options in long-acting removable contraceptives in the next 50 years, such as “a flexible IUD, not the semi-rigid T-shaped ones we have currently.”

The development and use of contraception methods targeted to men should play more of a significant role, he added. “For decades, there's been ongoing research developing hormonal, testosterone-based, [gonadotropin-releasing hormone-based] preparations that are very effective at inhibiting spermatogenesis,” Dr. Plourd noted.

“That said, there seems to be some barriers to its acceptance in this country. I hope that in the next 50 years that is another option on the table for contraception.”

Dr. Kaunitz disclosed financial relationships with Teva Pharmaceuticals, Bayer, Ortho (Johnson & Johnson), Merck, Procter & Gamble, Becton Dickinson, Sanofi-Aventis, and Medical Diagnostic Laboratories. Dr. Ogburn has been a consultant for Organon/Schering-Plough. Dr. Bhiwandi disclosed financial relationships with Teva Pharmaceuticals, Warner Chilcott, Boehringer Ingelheim, and Watson Pharmaceuticals. Dr. Plourd has been a speaker for Merck, Novartis, Sanofi-Aventis, Graceway, and Warner Chilcott.

Dr. Prager and Dr. Kaneshiro said they have no conflicts of interest.

SAN FRANCISCO — Fifty years after the introduction of oral contraceptives, physicians are looking to long-acting removable contraceptives to provide the next leap forward in preventing unintended pregnancy.

Three themes emerged in interviews with multiple physicians who gave separate presentations on contraception in sessions at the meeting.

First, nothing in the future of contraception is likely to match the revolutionary impact of oral contraception. Second, the great advances in contraception over the past half-decade still are accompanied by an unacceptably high rate of unintended pregnancies. And third, when asked to imagine what contraception might look like 50 years from now, most physicians looked to greater use of long-acting removable contraception (LARC) such as intrauterine devices (IUDs) or implants.

Long-acting removable contraception is the wave of the future, said Dr. Sarah Prager of the University of Washington, Seattle. sheeir advantage is that once the devices are inserted, they don't require patient participation in contraception, which has been one of the major stumbling blocks in contraceptive failures.

Not that physicians haven't kept trying new ways to get patients to remember to take their daily contraceptive pill. One prize-winning poster at the meeting reported on a randomized study that sent reminders by text messages on cell phones. It didn't help, reported Dr. Melody Y. Hou of Boston University and her associates. Among the 82 women, objective pill counts showed an average of five pills missed per cycle in both groups randomized to get or not get text messages.

The next 50 years probably will see improvements in long-acting removable contraceptives, Dr. Prager added. “Our longest-acting LARC method only lasts for 10-12 years,” she noted.

Dr. Joseph Anthony Ogburn of the University of New Mexico, Albuquerque, shared the same vision for the future. Approximately half of U.S. pregnancies are unintended, giving the United States the worst unintended pregnancy rate among developed countries, he noted.

Only about 1%-2% of U.S. women on contraception use an IUD, and less than 1% have a contraceptive implant. “If we could increase those numbers significantly, I think we could have a dramatic impact on the unintended pregnancy rate,” he said. Advances in the next 50 years probably will entail tweaking existing long-acting removable contraceptives to make them more acceptable.

Dr. Pouru Bhiwandi was more enthusiastic. “It's a very, very exciting time for all of contraception,” said Dr. Bhiwandi, an ob.gyn. in Raleigh, N.C., and an international consultant in women's health. “We have so many choices today, which we've never had before.”

Since the first oral contraceptive was approved in 1960, women's options grew with approval of more than 40 birth control pills and the development of other forms of hormonal contraception in transdermal patches, the vaginal ring, implants, and intrauterine devices (IUDs).

Modifications in dosing since the first oral contraceptives, which contained nearly four times the amount of estrogen and nearly 10 times the amount of progestin as today's formulations, have made the Pill safer and more acceptable, as has the development of newer estrogens and progesterones, she added. Newer regimens mean women no longer have to bleed while on hormonal contraception.

On the horizon are “exciting possibilities” for new products in barrier contraception that are both spermicidal and microbicidal to prevent sexually transmitted infections, plus “a whole range of new IUDs, a 1-year vaginal ring with a new progestin, and other products,” Dr. Bhiwandi said.

The U.S. should emulate Europe, where longer-acting methods of birth control, including IUDs and contraceptives are much more prevalent, said Dr. Andrew Kaunitz, professor of ob.gyn. at the University of Florida, Jacksonville.

Although U.S. clinical trials report a failure rate of 1%-2% with oral contraceptive use, in “typical practice” it's much higher, Dr. Kaunitz said—around nine women per 100 couples annually have unintended pregnancies on the Pill. “That's too high,” he said.

Dr. Bliss Kaneshiro of the University of Hawaii, Honolulu, noted that long-acting contraceptive devices are expensive and not always covered by insurance. “One of the big challenges, I think, is cost,” she said. “Our challenge for the next 50 years is improving access to those good contraceptive methods.”

Dr. David Plourd of the Naval Medical Center, San Diego, said he hopes to see more options in long-acting removable contraceptives in the next 50 years, such as “a flexible IUD, not the semi-rigid T-shaped ones we have currently.”

The development and use of contraception methods targeted to men should play more of a significant role, he added. “For decades, there's been ongoing research developing hormonal, testosterone-based, [gonadotropin-releasing hormone-based] preparations that are very effective at inhibiting spermatogenesis,” Dr. Plourd noted.

“That said, there seems to be some barriers to its acceptance in this country. I hope that in the next 50 years that is another option on the table for contraception.”

Dr. Kaunitz disclosed financial relationships with Teva Pharmaceuticals, Bayer, Ortho (Johnson & Johnson), Merck, Procter & Gamble, Becton Dickinson, Sanofi-Aventis, and Medical Diagnostic Laboratories. Dr. Ogburn has been a consultant for Organon/Schering-Plough. Dr. Bhiwandi disclosed financial relationships with Teva Pharmaceuticals, Warner Chilcott, Boehringer Ingelheim, and Watson Pharmaceuticals. Dr. Plourd has been a speaker for Merck, Novartis, Sanofi-Aventis, Graceway, and Warner Chilcott.

Dr. Prager and Dr. Kaneshiro said they have no conflicts of interest.

SAN FRANCISCO — Fifty years after the introduction of oral contraceptives, physicians are looking to long-acting removable contraceptives to provide the next leap forward in preventing unintended pregnancy.

Three themes emerged in interviews with multiple physicians who gave separate presentations on contraception in sessions at the meeting.

First, nothing in the future of contraception is likely to match the revolutionary impact of oral contraception. Second, the great advances in contraception over the past half-decade still are accompanied by an unacceptably high rate of unintended pregnancies. And third, when asked to imagine what contraception might look like 50 years from now, most physicians looked to greater use of long-acting removable contraception (LARC) such as intrauterine devices (IUDs) or implants.

Long-acting removable contraception is the wave of the future, said Dr. Sarah Prager of the University of Washington, Seattle. sheeir advantage is that once the devices are inserted, they don't require patient participation in contraception, which has been one of the major stumbling blocks in contraceptive failures.

Not that physicians haven't kept trying new ways to get patients to remember to take their daily contraceptive pill. One prize-winning poster at the meeting reported on a randomized study that sent reminders by text messages on cell phones. It didn't help, reported Dr. Melody Y. Hou of Boston University and her associates. Among the 82 women, objective pill counts showed an average of five pills missed per cycle in both groups randomized to get or not get text messages.

The next 50 years probably will see improvements in long-acting removable contraceptives, Dr. Prager added. “Our longest-acting LARC method only lasts for 10-12 years,” she noted.

Dr. Joseph Anthony Ogburn of the University of New Mexico, Albuquerque, shared the same vision for the future. Approximately half of U.S. pregnancies are unintended, giving the United States the worst unintended pregnancy rate among developed countries, he noted.

Only about 1%-2% of U.S. women on contraception use an IUD, and less than 1% have a contraceptive implant. “If we could increase those numbers significantly, I think we could have a dramatic impact on the unintended pregnancy rate,” he said. Advances in the next 50 years probably will entail tweaking existing long-acting removable contraceptives to make them more acceptable.

Dr. Pouru Bhiwandi was more enthusiastic. “It's a very, very exciting time for all of contraception,” said Dr. Bhiwandi, an ob.gyn. in Raleigh, N.C., and an international consultant in women's health. “We have so many choices today, which we've never had before.”

Since the first oral contraceptive was approved in 1960, women's options grew with approval of more than 40 birth control pills and the development of other forms of hormonal contraception in transdermal patches, the vaginal ring, implants, and intrauterine devices (IUDs).

Modifications in dosing since the first oral contraceptives, which contained nearly four times the amount of estrogen and nearly 10 times the amount of progestin as today's formulations, have made the Pill safer and more acceptable, as has the development of newer estrogens and progesterones, she added. Newer regimens mean women no longer have to bleed while on hormonal contraception.

On the horizon are “exciting possibilities” for new products in barrier contraception that are both spermicidal and microbicidal to prevent sexually transmitted infections, plus “a whole range of new IUDs, a 1-year vaginal ring with a new progestin, and other products,” Dr. Bhiwandi said.

The U.S. should emulate Europe, where longer-acting methods of birth control, including IUDs and contraceptives are much more prevalent, said Dr. Andrew Kaunitz, professor of ob.gyn. at the University of Florida, Jacksonville.

Although U.S. clinical trials report a failure rate of 1%-2% with oral contraceptive use, in “typical practice” it's much higher, Dr. Kaunitz said—around nine women per 100 couples annually have unintended pregnancies on the Pill. “That's too high,” he said.

Dr. Bliss Kaneshiro of the University of Hawaii, Honolulu, noted that long-acting contraceptive devices are expensive and not always covered by insurance. “One of the big challenges, I think, is cost,” she said. “Our challenge for the next 50 years is improving access to those good contraceptive methods.”

Dr. David Plourd of the Naval Medical Center, San Diego, said he hopes to see more options in long-acting removable contraceptives in the next 50 years, such as “a flexible IUD, not the semi-rigid T-shaped ones we have currently.”

The development and use of contraception methods targeted to men should play more of a significant role, he added. “For decades, there's been ongoing research developing hormonal, testosterone-based, [gonadotropin-releasing hormone-based] preparations that are very effective at inhibiting spermatogenesis,” Dr. Plourd noted.

“That said, there seems to be some barriers to its acceptance in this country. I hope that in the next 50 years that is another option on the table for contraception.”

Dr. Kaunitz disclosed financial relationships with Teva Pharmaceuticals, Bayer, Ortho (Johnson & Johnson), Merck, Procter & Gamble, Becton Dickinson, Sanofi-Aventis, and Medical Diagnostic Laboratories. Dr. Ogburn has been a consultant for Organon/Schering-Plough. Dr. Bhiwandi disclosed financial relationships with Teva Pharmaceuticals, Warner Chilcott, Boehringer Ingelheim, and Watson Pharmaceuticals. Dr. Plourd has been a speaker for Merck, Novartis, Sanofi-Aventis, Graceway, and Warner Chilcott.

Dr. Prager and Dr. Kaneshiro said they have no conflicts of interest.

LONG BEACH, CALIF. — Disease-specific tools for management of the most common reasons that patients move back and forth between such facilities and hospitals reduced short-term rehospitalizations among 3,255 residents of 10 skilled nursing facilities, according to the company that developed the tools.

The automated “care guides” to skilled nursing facility (SNF) management of patients reduced rehospitalizations within 30 days of discharge from 24% before the study to 14% over a year's time. However, rates of rehospitalization more than 30 days after discharge increased from 4% to 6%, Dr. Thomas Riemenschneider and his associates reported in a poster at the annual meeting of the American Medical Directors Association (AMDA).

The guides focus on disease management, standardized nursing processes, outcomes measurement, and performance improvement to stabilize recently hospitalized residents. Most SNF residents who bounce back to hospitals within 30 days of discharge do so multiple times, noted Dr. Riemenschneider, chief medical officer of the company that developed and is marketing the management tools, Clinical Outcomes Management Solutions (COMS) Interactive, Hudson, Ohio.

Avoiding rehospitalization was better for patients, who were less likely to die by the end of the study (3%) than before (6%), he reported.

For each hospitalization avoided, an SNF gained an average $4,000 in reimbursements for a longer resident stay.

More information about the care guides can be found on the company's Web site, www.comsllc.com

Dr. Riemenschneider and his associates in the study hold stock in COMS Interactive.

To view a video interview of Dr. Riemenschneider, go to youtube.com/ElsGlobalMedicalNews

LONG BEACH, CALIF. — Disease-specific tools for management of the most common reasons that patients move back and forth between such facilities and hospitals reduced short-term rehospitalizations among 3,255 residents of 10 skilled nursing facilities, according to the company that developed the tools.

The automated “care guides” to skilled nursing facility (SNF) management of patients reduced rehospitalizations within 30 days of discharge from 24% before the study to 14% over a year's time. However, rates of rehospitalization more than 30 days after discharge increased from 4% to 6%, Dr. Thomas Riemenschneider and his associates reported in a poster at the annual meeting of the American Medical Directors Association (AMDA).

The guides focus on disease management, standardized nursing processes, outcomes measurement, and performance improvement to stabilize recently hospitalized residents. Most SNF residents who bounce back to hospitals within 30 days of discharge do so multiple times, noted Dr. Riemenschneider, chief medical officer of the company that developed and is marketing the management tools, Clinical Outcomes Management Solutions (COMS) Interactive, Hudson, Ohio.

Avoiding rehospitalization was better for patients, who were less likely to die by the end of the study (3%) than before (6%), he reported.

For each hospitalization avoided, an SNF gained an average $4,000 in reimbursements for a longer resident stay.

More information about the care guides can be found on the company's Web site, www.comsllc.com

Dr. Riemenschneider and his associates in the study hold stock in COMS Interactive.

To view a video interview of Dr. Riemenschneider, go to youtube.com/ElsGlobalMedicalNews

LONG BEACH, CALIF. — Disease-specific tools for management of the most common reasons that patients move back and forth between such facilities and hospitals reduced short-term rehospitalizations among 3,255 residents of 10 skilled nursing facilities, according to the company that developed the tools.

The automated “care guides” to skilled nursing facility (SNF) management of patients reduced rehospitalizations within 30 days of discharge from 24% before the study to 14% over a year's time. However, rates of rehospitalization more than 30 days after discharge increased from 4% to 6%, Dr. Thomas Riemenschneider and his associates reported in a poster at the annual meeting of the American Medical Directors Association (AMDA).

The guides focus on disease management, standardized nursing processes, outcomes measurement, and performance improvement to stabilize recently hospitalized residents. Most SNF residents who bounce back to hospitals within 30 days of discharge do so multiple times, noted Dr. Riemenschneider, chief medical officer of the company that developed and is marketing the management tools, Clinical Outcomes Management Solutions (COMS) Interactive, Hudson, Ohio.

Avoiding rehospitalization was better for patients, who were less likely to die by the end of the study (3%) than before (6%), he reported.

For each hospitalization avoided, an SNF gained an average $4,000 in reimbursements for a longer resident stay.

More information about the care guides can be found on the company's Web site, www.comsllc.com

Dr. Riemenschneider and his associates in the study hold stock in COMS Interactive.

To view a video interview of Dr. Riemenschneider, go to youtube.com/ElsGlobalMedicalNews

LONG BEACH, CALIF. — Using interdisciplinary teams in a systematic way can help nursing homes meet requirements that they stop excessive use of psychoactive medications in residents.

Three reports from the meeting showed how facilities are using interdisciplinary teams to comply with Federal Health Regulations for Long-Term Care Facilities rule 329 (F-Tag 329), which mandates that “each resident's medication regimen must be free from unnecessary drugs,” and to comply with state regulations such as California's State Operations Manual Appendix PP, which requires consideration of gradual dose reductions to avoid unnecessary medications.

At a 230-bed long-term care facility in San Antonio, an interdisciplinary team approach reduced antipsychotic use by 74%, anxiolytic use by 23%, and stimulant use by 13% within 6 months, Dr. Kunle Adedeji and associates reported in a poster presentation.

The facility had been contracting with a psychiatry group to provide mental health services and collaborate with the medical director on all psychoactive prescriptions. The new interdisciplinary team included the facility's medical director, consulting pharmacist, director of nursing, nurse manager, Minimum Data Set coordinator, two social service representatives, and the consulting psychiatry group's nurse practitioner.

The team met monthly to review the cases of all residents who were prescribed psychoactive drugs within the preceding month. Members discussed concerns about each patient, made recommendations for reducing or discontinuing medications, and made sure that each psychoactive drug prescription had a specific diagnosis linked to it.

The use of antipsychotics had been slightly higher in the facility than state and national averages before the multidisciplinary team formed. But 6 months later, usage was down to 6% of residents, far below those averages, reported Dr. Adedeji of the University of Texas Health Science Center, San Antonio.

The team's efforts were supplemented by systematic implementation of nonpharmacologic treatments such as offering residents “busy boxes” or gardening to reduce agitation. The team implemented protocols for discontinuation of “as needed” medications for anxiety and sleep management. Floor staff underwent training in managing residents with dementia and behavioral problems.

The facility now plans to apply an interdisciplinary team approach to other areas, such as the use of physical restraints when dealing with behavioral problems.

Psychoactive Drug Doses Reduced

At a 150-bed skilled nursing facility in Hendersonville, N.C., 6 months of an interdisciplinary team approach reduced the use of antipsychotics by 54%, reduced anxiolytic use by 54%, decreased the use of hypnotics more than twice per week by 64%, and lowered psychiatric discharges to hospitals by 72%, Mark Coggins, Pharm.D., and his associates reported in a separate poster presentation.

The interdisciplinary team included a consultant pharmacist, nurse, social worker, dietician, therapy staff, and activity staff. They met twice weekly to discuss individual needs and interventions for residents who were on psychoactive drugs or whom staff identified as having weight loss, disruptive behaviors, pressure ulcers, or falls.

Each resident in those categories was reviewed every 4 weeks, and the team gave the attending physician its recommendations on gradual dose reduction of psychoactive drugs, pain management, depression treatment, therapy referrals, individualized activities, and nutritional interventions.

The attending physicians accepted the team's recommendations 93% of the time, said Dr. Coggins of Golden Living Centers, Inman, S.C. The incidence of untreated depression dropped by 47%, and the proportion of residents experiencing increased symptoms of depression or anxiety fell by 10%.

Rates of pressure ulcers declined by 66%, falls in high-risk residents were reduced by 25%, hospitalizations for falls declined by 23%, and fractures fell by 17%.

Better Documentation, Better Surveys

Even without measuring outcomes, using a multidisciplinary team approach can help nursing homes stay in compliance with requirements for regular consideration of gradual dose reductions, geriatrician Dr. Jay S. Luxenberg said in an oral presentation.

At the 430-bed Jewish Home, San Francisco, where he is medical director, an interdisciplinary team doing weekly “drug rounds” reviews residents on psychoactive drugs, so that each of those residents is reviewed at least every 6 months.

The team—consisting of the medical director, two psychiatrists, a nurse practitioner, a pharmacist, and usually representatives of the floor unit's social workers or nurses—assesses drug indications, documentation, consent, efficacy parameters, side effects, nonpharmacologic strategies, and previous or ongoing gradual dose reductions. It then presents recommendations to the attending physician about whether a gradual dose reduction would be appropriate, and the attending must document agreement or give a rationale for not accepting the recommendation.

“So far, that has helped us tremendously” in improving documentation and avoiding deficiencies on annual surveys by regulators, Dr. Luxenberg said. “Surveyors are very generous when you have documented well,” he noted.

“We need to step away from the defense that the person is doing well, so we don't want to change anything. A lot of our physicians have that as a gut feeling,” Dr. Luxenberg said.

The speakers and investigators in this article said they have no conflicts of interest related to these topics.

To view a video interview of Dr. Luxenberg, go to

youtube.com/ElsGlobalMedicalNews

A team approach can help nursing homes comply with requirements for regular consideration of dose reductions.

Source DR. LUXENBURG

LONG BEACH, CALIF. — Using interdisciplinary teams in a systematic way can help nursing homes meet requirements that they stop excessive use of psychoactive medications in residents.

Three reports from the meeting showed how facilities are using interdisciplinary teams to comply with Federal Health Regulations for Long-Term Care Facilities rule 329 (F-Tag 329), which mandates that “each resident's medication regimen must be free from unnecessary drugs,” and to comply with state regulations such as California's State Operations Manual Appendix PP, which requires consideration of gradual dose reductions to avoid unnecessary medications.

At a 230-bed long-term care facility in San Antonio, an interdisciplinary team approach reduced antipsychotic use by 74%, anxiolytic use by 23%, and stimulant use by 13% within 6 months, Dr. Kunle Adedeji and associates reported in a poster presentation.

The facility had been contracting with a psychiatry group to provide mental health services and collaborate with the medical director on all psychoactive prescriptions. The new interdisciplinary team included the facility's medical director, consulting pharmacist, director of nursing, nurse manager, Minimum Data Set coordinator, two social service representatives, and the consulting psychiatry group's nurse practitioner.

The team met monthly to review the cases of all residents who were prescribed psychoactive drugs within the preceding month. Members discussed concerns about each patient, made recommendations for reducing or discontinuing medications, and made sure that each psychoactive drug prescription had a specific diagnosis linked to it.

The use of antipsychotics had been slightly higher in the facility than state and national averages before the multidisciplinary team formed. But 6 months later, usage was down to 6% of residents, far below those averages, reported Dr. Adedeji of the University of Texas Health Science Center, San Antonio.

The team's efforts were supplemented by systematic implementation of nonpharmacologic treatments such as offering residents “busy boxes” or gardening to reduce agitation. The team implemented protocols for discontinuation of “as needed” medications for anxiety and sleep management. Floor staff underwent training in managing residents with dementia and behavioral problems.

The facility now plans to apply an interdisciplinary team approach to other areas, such as the use of physical restraints when dealing with behavioral problems.

Psychoactive Drug Doses Reduced

At a 150-bed skilled nursing facility in Hendersonville, N.C., 6 months of an interdisciplinary team approach reduced the use of antipsychotics by 54%, reduced anxiolytic use by 54%, decreased the use of hypnotics more than twice per week by 64%, and lowered psychiatric discharges to hospitals by 72%, Mark Coggins, Pharm.D., and his associates reported in a separate poster presentation.

The interdisciplinary team included a consultant pharmacist, nurse, social worker, dietician, therapy staff, and activity staff. They met twice weekly to discuss individual needs and interventions for residents who were on psychoactive drugs or whom staff identified as having weight loss, disruptive behaviors, pressure ulcers, or falls.

Each resident in those categories was reviewed every 4 weeks, and the team gave the attending physician its recommendations on gradual dose reduction of psychoactive drugs, pain management, depression treatment, therapy referrals, individualized activities, and nutritional interventions.

The attending physicians accepted the team's recommendations 93% of the time, said Dr. Coggins of Golden Living Centers, Inman, S.C. The incidence of untreated depression dropped by 47%, and the proportion of residents experiencing increased symptoms of depression or anxiety fell by 10%.

Rates of pressure ulcers declined by 66%, falls in high-risk residents were reduced by 25%, hospitalizations for falls declined by 23%, and fractures fell by 17%.

Better Documentation, Better Surveys

Even without measuring outcomes, using a multidisciplinary team approach can help nursing homes stay in compliance with requirements for regular consideration of gradual dose reductions, geriatrician Dr. Jay S. Luxenberg said in an oral presentation.

At the 430-bed Jewish Home, San Francisco, where he is medical director, an interdisciplinary team doing weekly “drug rounds” reviews residents on psychoactive drugs, so that each of those residents is reviewed at least every 6 months.

The team—consisting of the medical director, two psychiatrists, a nurse practitioner, a pharmacist, and usually representatives of the floor unit's social workers or nurses—assesses drug indications, documentation, consent, efficacy parameters, side effects, nonpharmacologic strategies, and previous or ongoing gradual dose reductions. It then presents recommendations to the attending physician about whether a gradual dose reduction would be appropriate, and the attending must document agreement or give a rationale for not accepting the recommendation.

“So far, that has helped us tremendously” in improving documentation and avoiding deficiencies on annual surveys by regulators, Dr. Luxenberg said. “Surveyors are very generous when you have documented well,” he noted.

“We need to step away from the defense that the person is doing well, so we don't want to change anything. A lot of our physicians have that as a gut feeling,” Dr. Luxenberg said.

The speakers and investigators in this article said they have no conflicts of interest related to these topics.

To view a video interview of Dr. Luxenberg, go to

youtube.com/ElsGlobalMedicalNews

A team approach can help nursing homes comply with requirements for regular consideration of dose reductions.

Source DR. LUXENBURG

LONG BEACH, CALIF. — Using interdisciplinary teams in a systematic way can help nursing homes meet requirements that they stop excessive use of psychoactive medications in residents.

Three reports from the meeting showed how facilities are using interdisciplinary teams to comply with Federal Health Regulations for Long-Term Care Facilities rule 329 (F-Tag 329), which mandates that “each resident's medication regimen must be free from unnecessary drugs,” and to comply with state regulations such as California's State Operations Manual Appendix PP, which requires consideration of gradual dose reductions to avoid unnecessary medications.

At a 230-bed long-term care facility in San Antonio, an interdisciplinary team approach reduced antipsychotic use by 74%, anxiolytic use by 23%, and stimulant use by 13% within 6 months, Dr. Kunle Adedeji and associates reported in a poster presentation.

The facility had been contracting with a psychiatry group to provide mental health services and collaborate with the medical director on all psychoactive prescriptions. The new interdisciplinary team included the facility's medical director, consulting pharmacist, director of nursing, nurse manager, Minimum Data Set coordinator, two social service representatives, and the consulting psychiatry group's nurse practitioner.

The team met monthly to review the cases of all residents who were prescribed psychoactive drugs within the preceding month. Members discussed concerns about each patient, made recommendations for reducing or discontinuing medications, and made sure that each psychoactive drug prescription had a specific diagnosis linked to it.

The use of antipsychotics had been slightly higher in the facility than state and national averages before the multidisciplinary team formed. But 6 months later, usage was down to 6% of residents, far below those averages, reported Dr. Adedeji of the University of Texas Health Science Center, San Antonio.

The team's efforts were supplemented by systematic implementation of nonpharmacologic treatments such as offering residents “busy boxes” or gardening to reduce agitation. The team implemented protocols for discontinuation of “as needed” medications for anxiety and sleep management. Floor staff underwent training in managing residents with dementia and behavioral problems.

The facility now plans to apply an interdisciplinary team approach to other areas, such as the use of physical restraints when dealing with behavioral problems.

Psychoactive Drug Doses Reduced

At a 150-bed skilled nursing facility in Hendersonville, N.C., 6 months of an interdisciplinary team approach reduced the use of antipsychotics by 54%, reduced anxiolytic use by 54%, decreased the use of hypnotics more than twice per week by 64%, and lowered psychiatric discharges to hospitals by 72%, Mark Coggins, Pharm.D., and his associates reported in a separate poster presentation.

The interdisciplinary team included a consultant pharmacist, nurse, social worker, dietician, therapy staff, and activity staff. They met twice weekly to discuss individual needs and interventions for residents who were on psychoactive drugs or whom staff identified as having weight loss, disruptive behaviors, pressure ulcers, or falls.

Each resident in those categories was reviewed every 4 weeks, and the team gave the attending physician its recommendations on gradual dose reduction of psychoactive drugs, pain management, depression treatment, therapy referrals, individualized activities, and nutritional interventions.

The attending physicians accepted the team's recommendations 93% of the time, said Dr. Coggins of Golden Living Centers, Inman, S.C. The incidence of untreated depression dropped by 47%, and the proportion of residents experiencing increased symptoms of depression or anxiety fell by 10%.

Rates of pressure ulcers declined by 66%, falls in high-risk residents were reduced by 25%, hospitalizations for falls declined by 23%, and fractures fell by 17%.

Better Documentation, Better Surveys

Even without measuring outcomes, using a multidisciplinary team approach can help nursing homes stay in compliance with requirements for regular consideration of gradual dose reductions, geriatrician Dr. Jay S. Luxenberg said in an oral presentation.

At the 430-bed Jewish Home, San Francisco, where he is medical director, an interdisciplinary team doing weekly “drug rounds” reviews residents on psychoactive drugs, so that each of those residents is reviewed at least every 6 months.

The team—consisting of the medical director, two psychiatrists, a nurse practitioner, a pharmacist, and usually representatives of the floor unit's social workers or nurses—assesses drug indications, documentation, consent, efficacy parameters, side effects, nonpharmacologic strategies, and previous or ongoing gradual dose reductions. It then presents recommendations to the attending physician about whether a gradual dose reduction would be appropriate, and the attending must document agreement or give a rationale for not accepting the recommendation.

“So far, that has helped us tremendously” in improving documentation and avoiding deficiencies on annual surveys by regulators, Dr. Luxenberg said. “Surveyors are very generous when you have documented well,” he noted.

“We need to step away from the defense that the person is doing well, so we don't want to change anything. A lot of our physicians have that as a gut feeling,” Dr. Luxenberg said.

The speakers and investigators in this article said they have no conflicts of interest related to these topics.

To view a video interview of Dr. Luxenberg, go to

youtube.com/ElsGlobalMedicalNews

A team approach can help nursing homes comply with requirements for regular consideration of dose reductions.

Source DR. LUXENBURG

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with an NSAID, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 had comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee.

One 80-year-old woman with hypertension and diabetes, among the 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and his associates reported in a poster presentation.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo gel, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif.

NSAIDs are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. In the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 on diclofenac and in 2 (13%) of 15 on placebo, though none developed an adverse cardiovascular event.

Dr. Barthel conducted the study under a research contract for Novartis, which makes Voltaren. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the drug.

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with an NSAID, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 had comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee.

One 80-year-old woman with hypertension and diabetes, among the 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and his associates reported in a poster presentation.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo gel, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif.

NSAIDs are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. In the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 on diclofenac and in 2 (13%) of 15 on placebo, though none developed an adverse cardiovascular event.

Dr. Barthel conducted the study under a research contract for Novartis, which makes Voltaren. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the drug.

LONG BEACH, CALIF. — A higher rate of adverse events in older patients with knee osteoarthritis treated topically for 12 weeks with an NSAID, compared with placebo, was caused mainly by application-site reactions but included one serious cardiovascular event that might have been related to the drug treatment, a post hoc analysis of data on 538 patients found.

The investigators analyzed data on people aged 65 years and older with symptomatic knee osteoarthritis (433 had comorbid hypertension, diabetes, or cardiovascular disease). Their source was three larger randomized, double-blind trials—two unpublished—that had looked at broader populations. Patients applied 4 g/day of either diclofenac sodium 1% gel (Voltaren) or the drug's vehicle to one painful knee.

One 80-year-old woman with hypertension and diabetes, among the 274 patients on diclofenac sodium 1% gel, developed deep vein thrombosis and pulmonary embolism that possibly was related to treatment, Dr. H. Richard Barthel and his associates reported in a poster presentation.

Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo gel, added Dr. Barthel, a rheumatologist in Santa Barbara, Calif.

NSAIDs are known to increase risk for cardiovascular or renal problems in a dose-related fashion, especially in older patients and people with hypertension, diabetes, or cardiovascular disease. Topical formulations may reduce this risk by reducing systemic exposure to NSAIDs compared with oral formulations. The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs. placebo.

Application-site reactions occurred in 8.8% on diclofenac gel and 1.1% on placebo. Serious adverse events occurred in 2.6% on diclofenac and 1.1% on placebo. Adverse cardiovascular events were seen in 2.6% on diclofenac and 1.1% on placebo. Adverse renal events were seen in 1.1% on diclofenac and 0.4% on placebo.

Among more common adverse events, 11% of subjects on diclofenac and 10% on placebo reported headache, 8% on diclofenac and 7% on placebo reported arthralgia, and 8% on diclofenac and 6% on placebo reported back pain.

The analysis included 307 patients with hypertension, 84 with diabetes, and 42 with cardiovascular disease. In the hypertension subgroup, adverse events were seen in 54% of 159 people randomized to diclofenac gel, compared with 45% of 148 people using placebo. In the diabetes subgroup, adverse events occurred in 19 (51%) of 37 patients treated with diclofenac and in 21 (48%) of 47 treated with placebo. In the subgroup with cardiovascular disease, adverse events occurred in 15 (56%) of 27 on diclofenac and in 2 (13%) of 15 on placebo, though none developed an adverse cardiovascular event.

Dr. Barthel conducted the study under a research contract for Novartis, which makes Voltaren. His associates in the study were employees of Novartis or of Endo Pharmaceuticals, which markets the drug.