Treating the psychological consequences of epilepsy can help improve patients’ health-related quality of life according to a recent Cochrane Library review.

• To arrive at that conclusion, researchers analyzed 24 randomized controlled trials that included 2439 patients, and narrowed down the review to 9 studies and 468 patients that included outcomes for quality of life.
• The 9 studies specifically looked at Quality of Life in Epilepsy-31 (QOLIE-31) outcomes, which were combined into a meta-analysis.
• Total scores for QOLIE-31 improved by 5.68 points (P<.0001), and subscores, which included metrics for emotional well being, energy/fatigue, and overall quality of life, improved as well.
• Reviewers categorized the quality of evidence supporting psychological treatment for patients with epilepsy as moderate, taking into account possible bias in 8 of 9 studies.

Michaelis R, Tang V, Wagner JL, et al. Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life. Epilepsia. 2018;59(2):315-332.

Treating the psychological consequences of epilepsy can help improve patients’ health-related quality of life according to a recent Cochrane Library review.

• To arrive at that conclusion, researchers analyzed 24 randomized controlled trials that included 2439 patients, and narrowed down the review to 9 studies and 468 patients that included outcomes for quality of life.
• The 9 studies specifically looked at Quality of Life in Epilepsy-31 (QOLIE-31) outcomes, which were combined into a meta-analysis.
• Total scores for QOLIE-31 improved by 5.68 points (P<.0001), and subscores, which included metrics for emotional well being, energy/fatigue, and overall quality of life, improved as well.
• Reviewers categorized the quality of evidence supporting psychological treatment for patients with epilepsy as moderate, taking into account possible bias in 8 of 9 studies.

Michaelis R, Tang V, Wagner JL, et al. Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life. Epilepsia. 2018;59(2):315-332.

Treating the psychological consequences of epilepsy can help improve patients’ health-related quality of life according to a recent Cochrane Library review.

• To arrive at that conclusion, researchers analyzed 24 randomized controlled trials that included 2439 patients, and narrowed down the review to 9 studies and 468 patients that included outcomes for quality of life.
• The 9 studies specifically looked at Quality of Life in Epilepsy-31 (QOLIE-31) outcomes, which were combined into a meta-analysis.
• Total scores for QOLIE-31 improved by 5.68 points (P<.0001), and subscores, which included metrics for emotional well being, energy/fatigue, and overall quality of life, improved as well.
• Reviewers categorized the quality of evidence supporting psychological treatment for patients with epilepsy as moderate, taking into account possible bias in 8 of 9 studies.

Michaelis R, Tang V, Wagner JL, et al. Cochrane systematic review and meta-analysis of the impact of psychological treatments for people with epilepsy on health-related quality of life. Epilepsia. 2018;59(2):315-332.

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. For complete FDA Drug Safety Labeling changes, please visit http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges.

CODEINE SULFATE: EPIVIR-HBV (LAMIVUDINE)

• Added to warning September 2017

WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, EXACERBATIONS OF HEPATITIS B, and RISK OF HIV-1 RESISTANCE IF EPIVIR-HBV IS USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue EPIVIR-HBV if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including EPIVIR-HBV). Hepatic function should be monitored closely with both clinical and laboratory followup for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

EPIVIR-HBV is not approved for the treatment of HIV-1 infection because the lamivudine dosage in EPIVIR-HBV is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with EPIVIR-HBV and periodically during treatment.

INVOKANA (CANAGLIFLOZIN)

• Added section to warning July 2017

WARNING: LOWER LIMB AMPUTATION

• An approximately 2-fold increased risk of lower limb amputations associated with INVOKANA use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
• Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
• Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.

Monitor patients receiving INVOKANA for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

INVOKAMET (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)

• Edited warning August 2017

WARNING: LACTIC ACIDOSIS and LOWER LIMB AMPUTATION

Lactic Acidosis

• Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Risk of Lower Limb Amputation

• In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, canagliflozin, a component of INVOKAMET, has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg.

INVOKAMET XR (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)

• Edited warning August 2017

WARNING: LACTIC ACIDOSIS and LOWER LIMB AMPUTATION

Lactic Acidosis

• Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as
  malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/ pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
• Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, cationic drugs such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
• Steps to reduce the risk of and manage metforminassociated lactic acidosis in these high risk groups are provided in the full prescribing information.
• If metformin-associated lactic acidosis is suspected, immediately discontinue INVOKAMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Risk of Lower Limb Amputation

• An approximately 2-fold increased risk of lower limb amputations associated with canagliflozin, a component of INVOKAMET, was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
• Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
• Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving INVOKAMET for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

JEVTANA KIT (CABAZITAXEL)

• Edited warning September 2017

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

Neutropenia: Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of less than or equal to 1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.

THYRO-TABS (LEVOTHYROXINE SODIUM)

• Added section to warning August 2017

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including THYRO-TABS, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.

Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)

• Edited warning August 2017

WARNING: TARDIVE DYSKINESIA

• Reglan can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.
• Discontinue Reglan in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after Reglan is stopped.
• Avoid treatment with Reglan for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. For complete FDA Drug Safety Labeling changes, please visit http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges.

CODEINE SULFATE: EPIVIR-HBV (LAMIVUDINE)

• Added to warning September 2017

WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, EXACERBATIONS OF HEPATITIS B, and RISK OF HIV-1 RESISTANCE IF EPIVIR-HBV IS USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue EPIVIR-HBV if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including EPIVIR-HBV). Hepatic function should be monitored closely with both clinical and laboratory followup for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

EPIVIR-HBV is not approved for the treatment of HIV-1 infection because the lamivudine dosage in EPIVIR-HBV is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with EPIVIR-HBV and periodically during treatment.

INVOKANA (CANAGLIFLOZIN)

• Added section to warning July 2017

WARNING: LOWER LIMB AMPUTATION

• An approximately 2-fold increased risk of lower limb amputations associated with INVOKANA use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
• Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
• Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.

Monitor patients receiving INVOKANA for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

INVOKAMET (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)

• Edited warning August 2017

WARNING: LACTIC ACIDOSIS and LOWER LIMB AMPUTATION

Lactic Acidosis

• Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Risk of Lower Limb Amputation

• In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, canagliflozin, a component of INVOKAMET, has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg.

INVOKAMET XR (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)

• Edited warning August 2017

WARNING: LACTIC ACIDOSIS and LOWER LIMB AMPUTATION

Lactic Acidosis

• Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as
  malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/ pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
• Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, cationic drugs such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
• Steps to reduce the risk of and manage metforminassociated lactic acidosis in these high risk groups are provided in the full prescribing information.
• If metformin-associated lactic acidosis is suspected, immediately discontinue INVOKAMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Risk of Lower Limb Amputation

• An approximately 2-fold increased risk of lower limb amputations associated with canagliflozin, a component of INVOKAMET, was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
• Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
• Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving INVOKAMET for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

JEVTANA KIT (CABAZITAXEL)

• Edited warning September 2017

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

Neutropenia: Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of less than or equal to 1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.

THYRO-TABS (LEVOTHYROXINE SODIUM)

• Added section to warning August 2017

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including THYRO-TABS, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.

Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)

• Edited warning August 2017

WARNING: TARDIVE DYSKINESIA

• Reglan can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.
• Discontinue Reglan in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after Reglan is stopped.
• Avoid treatment with Reglan for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted. For complete FDA Drug Safety Labeling changes, please visit http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges.

CODEINE SULFATE: EPIVIR-HBV (LAMIVUDINE)

• Added to warning September 2017

WARNING: LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, EXACERBATIONS OF HEPATITIS B, and RISK OF HIV-1 RESISTANCE IF EPIVIR-HBV IS USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue EPIVIR-HBV if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including EPIVIR-HBV). Hepatic function should be monitored closely with both clinical and laboratory followup for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

EPIVIR-HBV is not approved for the treatment of HIV-1 infection because the lamivudine dosage in EPIVIR-HBV is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with EPIVIR-HBV and periodically during treatment.

INVOKANA (CANAGLIFLOZIN)

• Added section to warning July 2017

WARNING: LOWER LIMB AMPUTATION

• An approximately 2-fold increased risk of lower limb amputations associated with INVOKANA use was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
• Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
• Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.

Monitor patients receiving INVOKANA for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

INVOKAMET (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)

• Edited warning August 2017

WARNING: LACTIC ACIDOSIS and LOWER LIMB AMPUTATION

Lactic Acidosis

• Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

Risk of Lower Limb Amputation

• In patients with type 2 diabetes who have established cardiovascular disease (CVD) or at risk for CVD, canagliflozin, a component of INVOKAMET, has been associated with lower limb amputations, most frequently of the toe and midfoot; some also involved the leg.

INVOKAMET XR (CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE)

• Edited warning August 2017

WARNING: LACTIC ACIDOSIS and LOWER LIMB AMPUTATION

Lactic Acidosis

• Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as
  malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/ pyruvate ratio; and metformin plasma levels generally >5 mcg/mL.
• Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, cationic drugs such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
• Steps to reduce the risk of and manage metforminassociated lactic acidosis in these high risk groups are provided in the full prescribing information.
• If metformin-associated lactic acidosis is suspected, immediately discontinue INVOKAMET and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Risk of Lower Limb Amputation

• An approximately 2-fold increased risk of lower limb amputations associated with canagliflozin, a component of INVOKAMET, was observed in CANVAS and CANVAS-R, two large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
• Amputations of the toe and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
• Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving INVOKAMET for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

JEVTANA KIT (CABAZITAXEL)

• Edited warning September 2017

WARNING: NEUTROPENIA AND HYPERSENSITIVITY

Neutropenia: Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. JEVTANA is contraindicated in patients with neutrophil counts of less than or equal to 1,500 cells/mm3. Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.

THYRO-TABS (LEVOTHYROXINE SODIUM)

• Added section to warning August 2017

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including THYRO-TABS, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.

Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

REGLAN (METOCLOPRAMIDE HYDROCHLORIDE)

• Edited warning August 2017

WARNING: TARDIVE DYSKINESIA

• Reglan can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.
• Discontinue Reglan in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after Reglan is stopped.
• Avoid treatment with Reglan for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

LOS ANGELES – The benefits seen early after placement of stem cells near the damaged brain site of chronic stroke patients continued during 2 years of follow-up, Gary K. Steinberg, MD, said at the International Stroke Conference, sponsored by the American Heart Association.

Seeing sustained benefit out to 2 years was “quite surprising. We thought we’d lose the benefit,” Dr. Steinberg said in a video interview.

The findings “change our notion of what happens after a stroke. The damaged circuits can be resurrected,” said Dr. Steinberg, professor and chair of neurosurgery at Stanford (Calif.) University.

He reported long-term follow-up data for 18 chronic stroke patients who had received transplantation of allogeneic bone marrow–derived stem cells. The study’s primary efficacy endpoint, at 6 months after treatment, showed clinically meaningful improvements in several measures of stroke disability and function in 13 of the 18 patients (72%), including a rise of at least 10 points in the Fugl-Meyer total motor function score.

His new report on 2-year follow-up showed that these 6-month improvements continued. The average increase in Fugl-Meyer score over baseline was about 18 points at 6, 12, and 24 months of follow-up.

Based on the promise shown in this pilot study, Dr. Steinberg and his associates are running a randomized study with 156 patients. Enrollment recently completed, and the results should be available during the second half of 2019, Dr. Steinberg said.

SanBio funded the study. Dr. Steinberg has been a consultant or advisor to Qool Therapeutics, Peter Lazic US, and NeuroSave.

[email protected]

SOURCE: Steinberg K et al. International Stroke Conference 2018, Abstract LB14.

LOS ANGELES – The benefits seen early after placement of stem cells near the damaged brain site of chronic stroke patients continued during 2 years of follow-up, Gary K. Steinberg, MD, said at the International Stroke Conference, sponsored by the American Heart Association.

Seeing sustained benefit out to 2 years was “quite surprising. We thought we’d lose the benefit,” Dr. Steinberg said in a video interview.

The findings “change our notion of what happens after a stroke. The damaged circuits can be resurrected,” said Dr. Steinberg, professor and chair of neurosurgery at Stanford (Calif.) University.

He reported long-term follow-up data for 18 chronic stroke patients who had received transplantation of allogeneic bone marrow–derived stem cells. The study’s primary efficacy endpoint, at 6 months after treatment, showed clinically meaningful improvements in several measures of stroke disability and function in 13 of the 18 patients (72%), including a rise of at least 10 points in the Fugl-Meyer total motor function score.

His new report on 2-year follow-up showed that these 6-month improvements continued. The average increase in Fugl-Meyer score over baseline was about 18 points at 6, 12, and 24 months of follow-up.

Based on the promise shown in this pilot study, Dr. Steinberg and his associates are running a randomized study with 156 patients. Enrollment recently completed, and the results should be available during the second half of 2019, Dr. Steinberg said.

SanBio funded the study. Dr. Steinberg has been a consultant or advisor to Qool Therapeutics, Peter Lazic US, and NeuroSave.

[email protected]

SOURCE: Steinberg K et al. International Stroke Conference 2018, Abstract LB14.

LOS ANGELES – The benefits seen early after placement of stem cells near the damaged brain site of chronic stroke patients continued during 2 years of follow-up, Gary K. Steinberg, MD, said at the International Stroke Conference, sponsored by the American Heart Association.

Seeing sustained benefit out to 2 years was “quite surprising. We thought we’d lose the benefit,” Dr. Steinberg said in a video interview.

The findings “change our notion of what happens after a stroke. The damaged circuits can be resurrected,” said Dr. Steinberg, professor and chair of neurosurgery at Stanford (Calif.) University.

He reported long-term follow-up data for 18 chronic stroke patients who had received transplantation of allogeneic bone marrow–derived stem cells. The study’s primary efficacy endpoint, at 6 months after treatment, showed clinically meaningful improvements in several measures of stroke disability and function in 13 of the 18 patients (72%), including a rise of at least 10 points in the Fugl-Meyer total motor function score.

His new report on 2-year follow-up showed that these 6-month improvements continued. The average increase in Fugl-Meyer score over baseline was about 18 points at 6, 12, and 24 months of follow-up.

Based on the promise shown in this pilot study, Dr. Steinberg and his associates are running a randomized study with 156 patients. Enrollment recently completed, and the results should be available during the second half of 2019, Dr. Steinberg said.

SanBio funded the study. Dr. Steinberg has been a consultant or advisor to Qool Therapeutics, Peter Lazic US, and NeuroSave.

[email protected]

SOURCE: Steinberg K et al. International Stroke Conference 2018, Abstract LB14.

Adding metronomic oral cyclophosphamide to trastuzumab and pertuzumab in frail elderly women with human epidermal growth factor receptor 2–positive metastatic breast cancer improved median progression-free survival by 7 months – with acceptable toxicity – vs. dual HER2 blockade alone in a randomized, open-label, phase 2 trial.

After a median follow-up of 20.7 months, the median progression-free survival (PFS) among 41 women who received trastuzumab and pertuzumab plus metronomic oral cyclophosphamide was 12.7 months, compared with 5.6 months among 39 women who received only trastuzumab and pertuzumab. Estimated PFS at 6 months was 73.4% and 46.2% in the groups, respectively (hazard ratio, 0.65), Hans Wildiers, MD, PhD, of University Hospitals Leuven, Belgium, and his colleagues reported in Lancet Oncology.

The most frequent grade 3-4 adverse events occurring in each group, respectively, were hypertension (12% and 15%), diarrhea (12% and 10%), dyspnea (10% and 5%), fatigue (5% and 8%), and pain (5% in each group). Thromboembolic events occurred in four patients (10%) receiving cyclophosphamide, while none occurred in the dual HER2 blockade-only group. Severe cardiac toxicities were occasionally observed in both groups.

Study subjects were women aged at least 70 years, or at least 60 years with confirmed functional restrictions. All had confirmed HER2-positive metastatic breast cancer and no prior chemotherapy for metastatic disease. They received either intravenous trastuzumab at a loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks, and intravenous pertuzumab at a loading dose of 840 mg followed by 420 mg every 3 weeks (median of 6 cycles), or those same doses of trastuzumab and pertuzumab plus metronomic oral cyclophosphamide at a dose of 50 mg daily (median of 13 cycles). Subsequent treatment with trastuzumab emtansine in 29 patients who progressed during the study was active and well tolerated; the overall PFS at 6 months in this group of patients was 49.5% and median PFS was 5 months after starting trastuzumab emtansine.

“The results of this study indicate that the benefit of avoiding the side effects of chemotherapy with the use of dual anti–HER2 blockade only does not compensate for an important loss of activity in the metastatic setting,” the investigators wrote, concluding that “trastuzumab and pertuzumab plus metronomic oral cyclophosphamide, potentially followed by trastuzumab emtansine after progression, might delay the need for, or supersede, the use of taxane-based chemotherapy in this population.”

Further evaluation of this combination in a randomized phase 3 study is warranted, as the phase 2 findings do not provide “robust justification for a change in practice.” They do, however, provide a scientific framework for supporting more specific trials in older patients, who compromise nearly a third of breast cancer patients worldwide, and up to 50% in high-income countries, they said.

This study was funded by F Hoffmann-La Roche. Dr. Wildiers has received research grants from Roche, and personal fees to his institute from Roche, Amgen, Novartis, Pfizer, Puma, and Celldex. Other authors also reported receiving research or other support from Roche Products, Eisai, Novartis Pharmaceuticals UK, Astellas/Medivation, Astra Zeneca, Celgene, Daiichi-Sankyo, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Merck Sharp & Dohme, Merus BV, Mylan, Novartis, Pfizer, Pierre Fabre, Sanofi, and Teva.

[email protected]

SOURCE: Wildiers H et al. Lancet Oncol. 2018 Feb 9. doi: 10.1016/S1470-2045(18)30083-4.

Adding metronomic oral cyclophosphamide to trastuzumab and pertuzumab in frail elderly women with human epidermal growth factor receptor 2–positive metastatic breast cancer improved median progression-free survival by 7 months – with acceptable toxicity – vs. dual HER2 blockade alone in a randomized, open-label, phase 2 trial.

After a median follow-up of 20.7 months, the median progression-free survival (PFS) among 41 women who received trastuzumab and pertuzumab plus metronomic oral cyclophosphamide was 12.7 months, compared with 5.6 months among 39 women who received only trastuzumab and pertuzumab. Estimated PFS at 6 months was 73.4% and 46.2% in the groups, respectively (hazard ratio, 0.65), Hans Wildiers, MD, PhD, of University Hospitals Leuven, Belgium, and his colleagues reported in Lancet Oncology.

The most frequent grade 3-4 adverse events occurring in each group, respectively, were hypertension (12% and 15%), diarrhea (12% and 10%), dyspnea (10% and 5%), fatigue (5% and 8%), and pain (5% in each group). Thromboembolic events occurred in four patients (10%) receiving cyclophosphamide, while none occurred in the dual HER2 blockade-only group. Severe cardiac toxicities were occasionally observed in both groups.

Study subjects were women aged at least 70 years, or at least 60 years with confirmed functional restrictions. All had confirmed HER2-positive metastatic breast cancer and no prior chemotherapy for metastatic disease. They received either intravenous trastuzumab at a loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks, and intravenous pertuzumab at a loading dose of 840 mg followed by 420 mg every 3 weeks (median of 6 cycles), or those same doses of trastuzumab and pertuzumab plus metronomic oral cyclophosphamide at a dose of 50 mg daily (median of 13 cycles). Subsequent treatment with trastuzumab emtansine in 29 patients who progressed during the study was active and well tolerated; the overall PFS at 6 months in this group of patients was 49.5% and median PFS was 5 months after starting trastuzumab emtansine.

“The results of this study indicate that the benefit of avoiding the side effects of chemotherapy with the use of dual anti–HER2 blockade only does not compensate for an important loss of activity in the metastatic setting,” the investigators wrote, concluding that “trastuzumab and pertuzumab plus metronomic oral cyclophosphamide, potentially followed by trastuzumab emtansine after progression, might delay the need for, or supersede, the use of taxane-based chemotherapy in this population.”

Further evaluation of this combination in a randomized phase 3 study is warranted, as the phase 2 findings do not provide “robust justification for a change in practice.” They do, however, provide a scientific framework for supporting more specific trials in older patients, who compromise nearly a third of breast cancer patients worldwide, and up to 50% in high-income countries, they said.

This study was funded by F Hoffmann-La Roche. Dr. Wildiers has received research grants from Roche, and personal fees to his institute from Roche, Amgen, Novartis, Pfizer, Puma, and Celldex. Other authors also reported receiving research or other support from Roche Products, Eisai, Novartis Pharmaceuticals UK, Astellas/Medivation, Astra Zeneca, Celgene, Daiichi-Sankyo, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Merck Sharp & Dohme, Merus BV, Mylan, Novartis, Pfizer, Pierre Fabre, Sanofi, and Teva.

[email protected]

SOURCE: Wildiers H et al. Lancet Oncol. 2018 Feb 9. doi: 10.1016/S1470-2045(18)30083-4.

Adding metronomic oral cyclophosphamide to trastuzumab and pertuzumab in frail elderly women with human epidermal growth factor receptor 2–positive metastatic breast cancer improved median progression-free survival by 7 months – with acceptable toxicity – vs. dual HER2 blockade alone in a randomized, open-label, phase 2 trial.

After a median follow-up of 20.7 months, the median progression-free survival (PFS) among 41 women who received trastuzumab and pertuzumab plus metronomic oral cyclophosphamide was 12.7 months, compared with 5.6 months among 39 women who received only trastuzumab and pertuzumab. Estimated PFS at 6 months was 73.4% and 46.2% in the groups, respectively (hazard ratio, 0.65), Hans Wildiers, MD, PhD, of University Hospitals Leuven, Belgium, and his colleagues reported in Lancet Oncology.

The most frequent grade 3-4 adverse events occurring in each group, respectively, were hypertension (12% and 15%), diarrhea (12% and 10%), dyspnea (10% and 5%), fatigue (5% and 8%), and pain (5% in each group). Thromboembolic events occurred in four patients (10%) receiving cyclophosphamide, while none occurred in the dual HER2 blockade-only group. Severe cardiac toxicities were occasionally observed in both groups.

Study subjects were women aged at least 70 years, or at least 60 years with confirmed functional restrictions. All had confirmed HER2-positive metastatic breast cancer and no prior chemotherapy for metastatic disease. They received either intravenous trastuzumab at a loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks, and intravenous pertuzumab at a loading dose of 840 mg followed by 420 mg every 3 weeks (median of 6 cycles), or those same doses of trastuzumab and pertuzumab plus metronomic oral cyclophosphamide at a dose of 50 mg daily (median of 13 cycles). Subsequent treatment with trastuzumab emtansine in 29 patients who progressed during the study was active and well tolerated; the overall PFS at 6 months in this group of patients was 49.5% and median PFS was 5 months after starting trastuzumab emtansine.

“The results of this study indicate that the benefit of avoiding the side effects of chemotherapy with the use of dual anti–HER2 blockade only does not compensate for an important loss of activity in the metastatic setting,” the investigators wrote, concluding that “trastuzumab and pertuzumab plus metronomic oral cyclophosphamide, potentially followed by trastuzumab emtansine after progression, might delay the need for, or supersede, the use of taxane-based chemotherapy in this population.”

Further evaluation of this combination in a randomized phase 3 study is warranted, as the phase 2 findings do not provide “robust justification for a change in practice.” They do, however, provide a scientific framework for supporting more specific trials in older patients, who compromise nearly a third of breast cancer patients worldwide, and up to 50% in high-income countries, they said.

This study was funded by F Hoffmann-La Roche. Dr. Wildiers has received research grants from Roche, and personal fees to his institute from Roche, Amgen, Novartis, Pfizer, Puma, and Celldex. Other authors also reported receiving research or other support from Roche Products, Eisai, Novartis Pharmaceuticals UK, Astellas/Medivation, Astra Zeneca, Celgene, Daiichi-Sankyo, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Merck Sharp & Dohme, Merus BV, Mylan, Novartis, Pfizer, Pierre Fabre, Sanofi, and Teva.

[email protected]

SOURCE: Wildiers H et al. Lancet Oncol. 2018 Feb 9. doi: 10.1016/S1470-2045(18)30083-4.

How much is $9 worth? Not much. Probably less than most people spend on coffee in a given week.

And yet, that $9 is really irritating to me.

For the last few weeks, when signing into Allscripts to send and refill prescriptions, I’ve encountered this:

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

How much is $9 worth? Not much. Probably less than most people spend on coffee in a given week.

And yet, that $9 is really irritating to me.

For the last few weeks, when signing into Allscripts to send and refill prescriptions, I’ve encountered this:

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

How much is $9 worth? Not much. Probably less than most people spend on coffee in a given week.

And yet, that $9 is really irritating to me.

For the last few weeks, when signing into Allscripts to send and refill prescriptions, I’ve encountered this:

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The Food and Drug Administration approved a new blood test on Feb. 14 – the Banyan Brain Trauma Indicator – for assessing patients with mild traumatic brain injuries, also known as concussions.

Most traumatic brain injuries are classified as “mild,” and the majority of patients have negative CT scans, according to an FDA announcement. Within a matter of hours, this test can help predict which patients will have negative scans by measuring certain proteins released by brain tissue, thereby potentially eliminating unnecessary imaging – and the costs and radiation exposure that would go along with it.

[email protected]

The Food and Drug Administration approved a new blood test on Feb. 14 – the Banyan Brain Trauma Indicator – for assessing patients with mild traumatic brain injuries, also known as concussions.

Most traumatic brain injuries are classified as “mild,” and the majority of patients have negative CT scans, according to an FDA announcement. Within a matter of hours, this test can help predict which patients will have negative scans by measuring certain proteins released by brain tissue, thereby potentially eliminating unnecessary imaging – and the costs and radiation exposure that would go along with it.

[email protected]

The Food and Drug Administration approved a new blood test on Feb. 14 – the Banyan Brain Trauma Indicator – for assessing patients with mild traumatic brain injuries, also known as concussions.

Most traumatic brain injuries are classified as “mild,” and the majority of patients have negative CT scans, according to an FDA announcement. Within a matter of hours, this test can help predict which patients will have negative scans by measuring certain proteins released by brain tissue, thereby potentially eliminating unnecessary imaging – and the costs and radiation exposure that would go along with it.

[email protected]

The influenza vaccine is only about 36% effective this year, preventing infections in just over a third of people who receive it, according to the Feb. 16 issue of Morbidity and Mortality Weekly Report.

The elderly are not among them. Although the vaccine was somewhat protective in children and adults up to 49 years old, “no statistically significant protection was observed in other age groups,” including people 65 years and older, reported investigators led by Brendan Flannery, PhD, of the Centers for Disease Control and Prevention influenza division.

Pradit_Ph/thinkstock

On a related note, on Feb. 18, Senators Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), and Amy Klobuchar (D-Minn.) held a press conference to announce they were introducing the Flu Vaccine Bill to dedicate $1 billion over a 5-year period in order to develop a flu vaccine that could provide lifetime protection. 

The investigators had no conflicts of interest.

[email protected]

SOURCE: Flannery B. et al. MMWR. 2018 Feb 16;67(6):180-5; Budd A. et al. MMWR. 2018 Feb 16;67(6):169-79.

The influenza vaccine is only about 36% effective this year, preventing infections in just over a third of people who receive it, according to the Feb. 16 issue of Morbidity and Mortality Weekly Report.

The elderly are not among them. Although the vaccine was somewhat protective in children and adults up to 49 years old, “no statistically significant protection was observed in other age groups,” including people 65 years and older, reported investigators led by Brendan Flannery, PhD, of the Centers for Disease Control and Prevention influenza division.

Pradit_Ph/thinkstock

On a related note, on Feb. 18, Senators Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), and Amy Klobuchar (D-Minn.) held a press conference to announce they were introducing the Flu Vaccine Bill to dedicate $1 billion over a 5-year period in order to develop a flu vaccine that could provide lifetime protection. 

The investigators had no conflicts of interest.

[email protected]

SOURCE: Flannery B. et al. MMWR. 2018 Feb 16;67(6):180-5; Budd A. et al. MMWR. 2018 Feb 16;67(6):169-79.

The influenza vaccine is only about 36% effective this year, preventing infections in just over a third of people who receive it, according to the Feb. 16 issue of Morbidity and Mortality Weekly Report.

The elderly are not among them. Although the vaccine was somewhat protective in children and adults up to 49 years old, “no statistically significant protection was observed in other age groups,” including people 65 years and older, reported investigators led by Brendan Flannery, PhD, of the Centers for Disease Control and Prevention influenza division.

Pradit_Ph/thinkstock

On a related note, on Feb. 18, Senators Edward J. Markey (D-Mass.), Richard Blumenthal (D-Conn.), and Amy Klobuchar (D-Minn.) held a press conference to announce they were introducing the Flu Vaccine Bill to dedicate $1 billion over a 5-year period in order to develop a flu vaccine that could provide lifetime protection. 

The investigators had no conflicts of interest.

[email protected]

SOURCE: Flannery B. et al. MMWR. 2018 Feb 16;67(6):180-5; Budd A. et al. MMWR. 2018 Feb 16;67(6):169-79.

I recently attended a local Charleston (S.C.) Medical Society meeting, the theme of which was the opioid crisis. Although at the time I did not see a perfect relevance of this crisis to hospital medicine, I attended anyway, hoping to gain some pearls of wisdom regarding what my role in this epidemic could be.

I was already certainly aware of the extent of the opioid epidemic, including some startling statistics. For example, the burden of the crisis totaled $95 billion in the United States in 2016 from lost productivity and health care and criminal justice system expenses.¹ But I was still not certain what my specific role could be in doing something about it.

The main speaker at the meeting was Nanci Steadman Shipman, the mother of a 19-year-old college student who had accidentally overdosed on heroin the year prior. She told the story of his upbringing, which was in an upper-middle-class suburban neighborhood, full of family, friends, and loving support. When her son was 15 years old, he suffered a leg injury during his lacrosse season, which led to a hospital stay, a surgery, and a prolonged recovery. It was during this period of time that, unbeknownst to his family, he became addicted to opioids.

Over the years, Nanci’s son found ever more creative mechanisms to procure various opioids, eventually resorting to heroin, which was remarkably cheap and easy to find. All the while in high school, he maintained good grades, remained active in sports, and had a normal social circle of friends. It was not until his first year of college that his mother started to worry that something might be wrong. In less than a year, her son quit sports, and his grades spiraled. Despite ongoing family support and extensive rehab, he suffered more than one setback and accidentally overdosed.

After her son’s death, Nanci started a nonprofit organization, Wake Up Carolina.² Its mission is to fight drug abuse among adolescents and young adults. They use a combination of education, awareness, prevention, and recovery tactics to achieve their task. In the meantime, they try to diminish the shame and secrecy among families suffering from opioid addiction. During Nanci’s presentation at the medical society meeting, the message she conveyed to us – an audience full of physicians – was simple: We can either be part of the problem or part of the solution; we all have a duty to help and a role to play in this crisis. Whether a patient is exposed first inside the hospital or outside of it, for a short period of time or for a long one, every opioid exposure comes with a risk. Nanci’s story was incredibly affecting and made me rethink my personal role in this epidemic; how might I have contributed to this, and what could I do differently?

Shortly after her son died, her younger son suffered a femur fracture during a football game. You can imagine the horror her family felt knowing that he would need some pain medication for his acute injury. Nanci and her family were able to work with the medical and surgical teams, and through multimodal pain regimens, her son received little to no opioids during the hospital stay and was able to recover from the fracture with reasonable pain levels. She expressed gratitude that the hospital teams were willing to listen to her and her family’s concerns and offer both pharmacological and nonpharmacological therapies for her son’s recovery, which allayed their fears about opioids.

From this incredibly powerful and moving story of one family’s experience, I was able to gather some very meaningful, evidence-based, and tangible practices that I could implement in my own organization. These might even help other hospitalists take an active role in stemming this sadly growing epidemic.



As hospitalists, we should work on the following:

• Improve our personal knowledge of and skills in utilizing multimodal pain therapies regardless of the etiology of the pain. These should include both pharmacologic and nonpharmacologic interventions.
• Use consultants to assist us with difficult cases. Depending on our practice setting, we should utilize consultants who can give us good advice on nonopioid pain management regimens, such as palliative care.
• Try to influence the practice of surgeons and other specialties that consult us, to help shape prescribing patterns that include nonopioid medical regimens, and to get doctors used to entertaining nonpharmacologic pain-reducing interventions.
• Limit the volume of prescription opioids written to our patients at the time of hospital discharge. There is mounting literature that suggests leftover prescriptions can be the start of an opioid addiction for a family member.
• Educate ourselves and our patients about any local “take back” programs that allow for safe, secure, and anonymous drops of prescription medications. This may reduce opioids getting into the hands of someone who might later become addicted.
• Find out whether our hospitals or health systems have a pain or opioid oversight group or team, and if not, see whether there is interest in starting one.
• Look into local community activist programs to partner with for education, awareness, prevention, or treatment options (such as Wake Up Carolina).
• Work with local resources (for example, case management, social workers, psychiatrists) to learn about and utilize local options for rehabilitation. We should actively and openly discuss these options with any patients known or suspected to be addicted.
• Make a valiant attempt to remove any unconscious bias against people who have become addicted to opioids. Continuing the social stigma of addiction only spurs the shame and secrecy.

Please share other ideas or suggestions you may have regarding the role hospitalists can have in curbing this growing epidemic.
 

References

1. “Burden of opioid crisis reached $95 billion in 2016; private sector hit hardest.” Altarum press release. Nov 16, 2017.

2. Wake Up Carolina website.








 

I recently attended a local Charleston (S.C.) Medical Society meeting, the theme of which was the opioid crisis. Although at the time I did not see a perfect relevance of this crisis to hospital medicine, I attended anyway, hoping to gain some pearls of wisdom regarding what my role in this epidemic could be.

I was already certainly aware of the extent of the opioid epidemic, including some startling statistics. For example, the burden of the crisis totaled $95 billion in the United States in 2016 from lost productivity and health care and criminal justice system expenses.¹ But I was still not certain what my specific role could be in doing something about it.

The main speaker at the meeting was Nanci Steadman Shipman, the mother of a 19-year-old college student who had accidentally overdosed on heroin the year prior. She told the story of his upbringing, which was in an upper-middle-class suburban neighborhood, full of family, friends, and loving support. When her son was 15 years old, he suffered a leg injury during his lacrosse season, which led to a hospital stay, a surgery, and a prolonged recovery. It was during this period of time that, unbeknownst to his family, he became addicted to opioids.

Over the years, Nanci’s son found ever more creative mechanisms to procure various opioids, eventually resorting to heroin, which was remarkably cheap and easy to find. All the while in high school, he maintained good grades, remained active in sports, and had a normal social circle of friends. It was not until his first year of college that his mother started to worry that something might be wrong. In less than a year, her son quit sports, and his grades spiraled. Despite ongoing family support and extensive rehab, he suffered more than one setback and accidentally overdosed.

After her son’s death, Nanci started a nonprofit organization, Wake Up Carolina.² Its mission is to fight drug abuse among adolescents and young adults. They use a combination of education, awareness, prevention, and recovery tactics to achieve their task. In the meantime, they try to diminish the shame and secrecy among families suffering from opioid addiction. During Nanci’s presentation at the medical society meeting, the message she conveyed to us – an audience full of physicians – was simple: We can either be part of the problem or part of the solution; we all have a duty to help and a role to play in this crisis. Whether a patient is exposed first inside the hospital or outside of it, for a short period of time or for a long one, every opioid exposure comes with a risk. Nanci’s story was incredibly affecting and made me rethink my personal role in this epidemic; how might I have contributed to this, and what could I do differently?

Shortly after her son died, her younger son suffered a femur fracture during a football game. You can imagine the horror her family felt knowing that he would need some pain medication for his acute injury. Nanci and her family were able to work with the medical and surgical teams, and through multimodal pain regimens, her son received little to no opioids during the hospital stay and was able to recover from the fracture with reasonable pain levels. She expressed gratitude that the hospital teams were willing to listen to her and her family’s concerns and offer both pharmacological and nonpharmacological therapies for her son’s recovery, which allayed their fears about opioids.

From this incredibly powerful and moving story of one family’s experience, I was able to gather some very meaningful, evidence-based, and tangible practices that I could implement in my own organization. These might even help other hospitalists take an active role in stemming this sadly growing epidemic.



As hospitalists, we should work on the following:

• Improve our personal knowledge of and skills in utilizing multimodal pain therapies regardless of the etiology of the pain. These should include both pharmacologic and nonpharmacologic interventions.
• Use consultants to assist us with difficult cases. Depending on our practice setting, we should utilize consultants who can give us good advice on nonopioid pain management regimens, such as palliative care.
• Try to influence the practice of surgeons and other specialties that consult us, to help shape prescribing patterns that include nonopioid medical regimens, and to get doctors used to entertaining nonpharmacologic pain-reducing interventions.
• Limit the volume of prescription opioids written to our patients at the time of hospital discharge. There is mounting literature that suggests leftover prescriptions can be the start of an opioid addiction for a family member.
• Educate ourselves and our patients about any local “take back” programs that allow for safe, secure, and anonymous drops of prescription medications. This may reduce opioids getting into the hands of someone who might later become addicted.
• Find out whether our hospitals or health systems have a pain or opioid oversight group or team, and if not, see whether there is interest in starting one.
• Look into local community activist programs to partner with for education, awareness, prevention, or treatment options (such as Wake Up Carolina).
• Work with local resources (for example, case management, social workers, psychiatrists) to learn about and utilize local options for rehabilitation. We should actively and openly discuss these options with any patients known or suspected to be addicted.
• Make a valiant attempt to remove any unconscious bias against people who have become addicted to opioids. Continuing the social stigma of addiction only spurs the shame and secrecy.

Please share other ideas or suggestions you may have regarding the role hospitalists can have in curbing this growing epidemic.
 

References

1. “Burden of opioid crisis reached $95 billion in 2016; private sector hit hardest.” Altarum press release. Nov 16, 2017.

2. Wake Up Carolina website.








 

I recently attended a local Charleston (S.C.) Medical Society meeting, the theme of which was the opioid crisis. Although at the time I did not see a perfect relevance of this crisis to hospital medicine, I attended anyway, hoping to gain some pearls of wisdom regarding what my role in this epidemic could be.

I was already certainly aware of the extent of the opioid epidemic, including some startling statistics. For example, the burden of the crisis totaled $95 billion in the United States in 2016 from lost productivity and health care and criminal justice system expenses.¹ But I was still not certain what my specific role could be in doing something about it.

The main speaker at the meeting was Nanci Steadman Shipman, the mother of a 19-year-old college student who had accidentally overdosed on heroin the year prior. She told the story of his upbringing, which was in an upper-middle-class suburban neighborhood, full of family, friends, and loving support. When her son was 15 years old, he suffered a leg injury during his lacrosse season, which led to a hospital stay, a surgery, and a prolonged recovery. It was during this period of time that, unbeknownst to his family, he became addicted to opioids.

Over the years, Nanci’s son found ever more creative mechanisms to procure various opioids, eventually resorting to heroin, which was remarkably cheap and easy to find. All the while in high school, he maintained good grades, remained active in sports, and had a normal social circle of friends. It was not until his first year of college that his mother started to worry that something might be wrong. In less than a year, her son quit sports, and his grades spiraled. Despite ongoing family support and extensive rehab, he suffered more than one setback and accidentally overdosed.

After her son’s death, Nanci started a nonprofit organization, Wake Up Carolina.² Its mission is to fight drug abuse among adolescents and young adults. They use a combination of education, awareness, prevention, and recovery tactics to achieve their task. In the meantime, they try to diminish the shame and secrecy among families suffering from opioid addiction. During Nanci’s presentation at the medical society meeting, the message she conveyed to us – an audience full of physicians – was simple: We can either be part of the problem or part of the solution; we all have a duty to help and a role to play in this crisis. Whether a patient is exposed first inside the hospital or outside of it, for a short period of time or for a long one, every opioid exposure comes with a risk. Nanci’s story was incredibly affecting and made me rethink my personal role in this epidemic; how might I have contributed to this, and what could I do differently?

Shortly after her son died, her younger son suffered a femur fracture during a football game. You can imagine the horror her family felt knowing that he would need some pain medication for his acute injury. Nanci and her family were able to work with the medical and surgical teams, and through multimodal pain regimens, her son received little to no opioids during the hospital stay and was able to recover from the fracture with reasonable pain levels. She expressed gratitude that the hospital teams were willing to listen to her and her family’s concerns and offer both pharmacological and nonpharmacological therapies for her son’s recovery, which allayed their fears about opioids.

From this incredibly powerful and moving story of one family’s experience, I was able to gather some very meaningful, evidence-based, and tangible practices that I could implement in my own organization. These might even help other hospitalists take an active role in stemming this sadly growing epidemic.



As hospitalists, we should work on the following:

• Improve our personal knowledge of and skills in utilizing multimodal pain therapies regardless of the etiology of the pain. These should include both pharmacologic and nonpharmacologic interventions.
• Use consultants to assist us with difficult cases. Depending on our practice setting, we should utilize consultants who can give us good advice on nonopioid pain management regimens, such as palliative care.
• Try to influence the practice of surgeons and other specialties that consult us, to help shape prescribing patterns that include nonopioid medical regimens, and to get doctors used to entertaining nonpharmacologic pain-reducing interventions.
• Limit the volume of prescription opioids written to our patients at the time of hospital discharge. There is mounting literature that suggests leftover prescriptions can be the start of an opioid addiction for a family member.
• Educate ourselves and our patients about any local “take back” programs that allow for safe, secure, and anonymous drops of prescription medications. This may reduce opioids getting into the hands of someone who might later become addicted.
• Find out whether our hospitals or health systems have a pain or opioid oversight group or team, and if not, see whether there is interest in starting one.
• Look into local community activist programs to partner with for education, awareness, prevention, or treatment options (such as Wake Up Carolina).
• Work with local resources (for example, case management, social workers, psychiatrists) to learn about and utilize local options for rehabilitation. We should actively and openly discuss these options with any patients known or suspected to be addicted.
• Make a valiant attempt to remove any unconscious bias against people who have become addicted to opioids. Continuing the social stigma of addiction only spurs the shame and secrecy.

Please share other ideas or suggestions you may have regarding the role hospitalists can have in curbing this growing epidemic.
 

References

1. “Burden of opioid crisis reached $95 billion in 2016; private sector hit hardest.” Altarum press release. Nov 16, 2017.

2. Wake Up Carolina website.








 

The American College of Surgeons (ACS) Division of Education is offering fellowships in surgical ethics with the MacLean Center for Clinical Medical Ethics, University of Chicago, IL. The MacLean Center will prepare two surgeons for careers that combine clinical surgery with scholarly studies in surgical ethics, beginning with a five-week, full-time course in Chicago in July and August 2018. From September 2018 to June 2019, fellowship recipients will meet weekly for a structured ethics curriculum. In addition, fellows will participate in an ethics consultation service and complete a research project.

For additional information about this fellowship, contact Patrice Gabler Blair, MPH, Associate Director, ACS Division of Education, at [email protected]. Application materials are now due March 15.

The American College of Surgeons (ACS) Division of Education is offering fellowships in surgical ethics with the MacLean Center for Clinical Medical Ethics, University of Chicago, IL. The MacLean Center will prepare two surgeons for careers that combine clinical surgery with scholarly studies in surgical ethics, beginning with a five-week, full-time course in Chicago in July and August 2018. From September 2018 to June 2019, fellowship recipients will meet weekly for a structured ethics curriculum. In addition, fellows will participate in an ethics consultation service and complete a research project.

For additional information about this fellowship, contact Patrice Gabler Blair, MPH, Associate Director, ACS Division of Education, at [email protected]. Application materials are now due March 15.

The American College of Surgeons (ACS) Division of Education is offering fellowships in surgical ethics with the MacLean Center for Clinical Medical Ethics, University of Chicago, IL. The MacLean Center will prepare two surgeons for careers that combine clinical surgery with scholarly studies in surgical ethics, beginning with a five-week, full-time course in Chicago in July and August 2018. From September 2018 to June 2019, fellowship recipients will meet weekly for a structured ethics curriculum. In addition, fellows will participate in an ethics consultation service and complete a research project.

For additional information about this fellowship, contact Patrice Gabler Blair, MPH, Associate Director, ACS Division of Education, at [email protected]. Application materials are now due March 15.

Registration is open for the 12th annual Residents as Teachers and Leaders Course hosted by the American College of Surgeons (ACS) Division of Education. The 2018 program, April 13−15 at the ACS headquarters in Chicago, IL, is designed specifically for surgery residents and will address the essential nonclinical skills—teaching and leading—that are required for success as surgeons and members of the health care team.

The course faculty, all experts in resident education, will provide an interactive learning environment. Residents will learn to lead a team more effectively, resolve conflict, be better teachers, give constructive feedback, and apply these skills during and after residency. The number of participants is limited to allow ample interaction with faculty and to facilitate networking. This course is targeted at mid- to senior-level residents, but all are welcome to attend.

Registration information and a brochure are available on the course web page at www.facs.org/education/division-of-education/courses/residents-as-teachers; the advance registration discount ends March 16. Note that last year’s course was oversubscribed, so register soon if you are interested in attending. Contact Kim Echert at [email protected] or at 312-202-5488 with any questions.








 

Registration is open for the 12th annual Residents as Teachers and Leaders Course hosted by the American College of Surgeons (ACS) Division of Education. The 2018 program, April 13−15 at the ACS headquarters in Chicago, IL, is designed specifically for surgery residents and will address the essential nonclinical skills—teaching and leading—that are required for success as surgeons and members of the health care team.

The course faculty, all experts in resident education, will provide an interactive learning environment. Residents will learn to lead a team more effectively, resolve conflict, be better teachers, give constructive feedback, and apply these skills during and after residency. The number of participants is limited to allow ample interaction with faculty and to facilitate networking. This course is targeted at mid- to senior-level residents, but all are welcome to attend.

Registration information and a brochure are available on the course web page at www.facs.org/education/division-of-education/courses/residents-as-teachers; the advance registration discount ends March 16. Note that last year’s course was oversubscribed, so register soon if you are interested in attending. Contact Kim Echert at [email protected] or at 312-202-5488 with any questions.








 

Registration is open for the 12th annual Residents as Teachers and Leaders Course hosted by the American College of Surgeons (ACS) Division of Education. The 2018 program, April 13−15 at the ACS headquarters in Chicago, IL, is designed specifically for surgery residents and will address the essential nonclinical skills—teaching and leading—that are required for success as surgeons and members of the health care team.

The course faculty, all experts in resident education, will provide an interactive learning environment. Residents will learn to lead a team more effectively, resolve conflict, be better teachers, give constructive feedback, and apply these skills during and after residency. The number of participants is limited to allow ample interaction with faculty and to facilitate networking. This course is targeted at mid- to senior-level residents, but all are welcome to attend.

Registration information and a brochure are available on the course web page at www.facs.org/education/division-of-education/courses/residents-as-teachers; the advance registration discount ends March 16. Note that last year’s course was oversubscribed, so register soon if you are interested in attending. Contact Kim Echert at [email protected] or at 312-202-5488 with any questions.