Metastatic melanoma is a highly challenging cancer to treat. Like other solid tumors, it is a very heterogeneous disease both clinically and biologically. Consequently, the first decision point in its management is to assess the severity of an individual patient’s disease. This can be done based on the patient’s symptoms and how they have evolved over the preceding 1-2 months, performance status, the extent of disease as determined by physical examination, and staging workup, which should include either computed tomography scans of the body or a positron emission tomography/CT study as well as a brain magnetic resonance imaging scan. Patients with brain metastases as a subset (which is sizable – 20%-25% have brain metastases) require special attention because they may not respond to systemic therapies and will thus have to be managed with brain-targeted treatment options. Tumor testing for BRAF mutations is necessary in all patients with metastatic melanoma because the BRAF inhibitors (vemurafenib or dabrafenib) are a preferred choice of targeted therapy for this subset of patients, which constitutes about 50% of all melanoma patients. Immunotherapy plays an important role in nearly all patients with metastatic melanoma including those who have progressed after anti-BRAF therapy. Chemotherapy still has a significant (yet diminishing) role for patients who are no longer suitable for immunotherapy.

Metastatic melanoma is a highly challenging cancer to treat. Like other solid tumors, it is a very heterogeneous disease both clinically and biologically. Consequently, the first decision point in its management is to assess the severity of an individual patient’s disease. This can be done based on the patient’s symptoms and how they have evolved over the preceding 1-2 months, performance status, the extent of disease as determined by physical examination, and staging workup, which should include either computed tomography scans of the body or a positron emission tomography/CT study as well as a brain magnetic resonance imaging scan. Patients with brain metastases as a subset (which is sizable – 20%-25% have brain metastases) require special attention because they may not respond to systemic therapies and will thus have to be managed with brain-targeted treatment options. Tumor testing for BRAF mutations is necessary in all patients with metastatic melanoma because the BRAF inhibitors (vemurafenib or dabrafenib) are a preferred choice of targeted therapy for this subset of patients, which constitutes about 50% of all melanoma patients. Immunotherapy plays an important role in nearly all patients with metastatic melanoma including those who have progressed after anti-BRAF therapy. Chemotherapy still has a significant (yet diminishing) role for patients who are no longer suitable for immunotherapy.

Metastatic melanoma is a highly challenging cancer to treat. Like other solid tumors, it is a very heterogeneous disease both clinically and biologically. Consequently, the first decision point in its management is to assess the severity of an individual patient’s disease. This can be done based on the patient’s symptoms and how they have evolved over the preceding 1-2 months, performance status, the extent of disease as determined by physical examination, and staging workup, which should include either computed tomography scans of the body or a positron emission tomography/CT study as well as a brain magnetic resonance imaging scan. Patients with brain metastases as a subset (which is sizable – 20%-25% have brain metastases) require special attention because they may not respond to systemic therapies and will thus have to be managed with brain-targeted treatment options. Tumor testing for BRAF mutations is necessary in all patients with metastatic melanoma because the BRAF inhibitors (vemurafenib or dabrafenib) are a preferred choice of targeted therapy for this subset of patients, which constitutes about 50% of all melanoma patients. Immunotherapy plays an important role in nearly all patients with metastatic melanoma including those who have progressed after anti-BRAF therapy. Chemotherapy still has a significant (yet diminishing) role for patients who are no longer suitable for immunotherapy.

Prescriptions
Credit: CDC

NEW ORLEANS—New data indicate a trend for longer overall survival and event-free survival in newly diagnosed chronic myeloid leukemia (CML) patients on nilotinib versus imatinib.

Five-year data from the phase 3 ENESTnd study demonstrate higher rates of early and deeper molecular response in newly diagnosed CML patients taking nilotinib, as well as a reduced risk of progression compared to imatinib.

These results were presented at the 2013 ASH Annual Meeting as abstract 92.

“These new, updated data reaffirm the superiority of nilotinib over imatinib at achieving deeper molecular responses and provide even more evidence supporting nilotinib as an appropriate treatment of choice in newly diagnosed patients,” said Giuseppe Saglio, MD, of the University of Turin in Italy.

“Now, we are looking at how deeper molecular responses may help guide our approach towards how we treat CML in the future.”

The 5-year ENESTnd data showed that nilotinib can produce superior responses across various Philadelphia chromosome-positive CML patient populations, including newly diagnosed patients. Results showed higher rates of early and deeper sustained molecular response, known as MR4.5.

The difference in the rates of MR4.5 continued to be higher when nilotinib was given at 300 mg or 400 mg twice daily, when compared to imatinib (MR4.5: 6%-10% difference by 1 year, 21%-23% difference by 5 years).

“The most important endpoint is cumulative incidence of MR4.5,” Dr Saglio said. “At 5 years, this is achieved by 54% of those in nilotinib-300-mg group, 52% in the nilotinib-400-mg group, and 31% in the imatinib group. And the curves are still diverging.” 

The data also indicate a trend for higher overall survival and event-free survival rates in patients treated with nilotinib.

Fifteen patients treated with imatinib had CML-related deaths, compared to 6 patients in the arm receiving nilotinib at 300 mg twice daily and 4 patients in the arm receiving nilotinib at 400 mg twice daily.

Few new adverse events and laboratory abnormalities were observed between year 4 and year 5. Rates of patients with adverse events leading to discontinuation were 11.1% in the 300-mg nilotinib group, 17.7% in the 400-mg nilotinib group, and 13.2% in the imatinib group.

Dr Saglio noted that select cardiac and vascular events are slightly more frequent on nilotinib versus imatinib. But there has been no increase in the annual incidence of these events over time.

Therefore, Dr Saglio concluded, “Nilotinib, a standard-of-care frontline therapy option for newly diagnosed, chronic-phase CML patients, affords superior efficacy compared with imatinib, including higher rates of early molecular response (which is associated with improved long-term outcomes), higher rates of deep molecular response, and a lower risk of disease progression. Nilotinib continues to show good tolerability with long-term follow-up.”

Prescriptions
Credit: CDC

NEW ORLEANS—New data indicate a trend for longer overall survival and event-free survival in newly diagnosed chronic myeloid leukemia (CML) patients on nilotinib versus imatinib.

Five-year data from the phase 3 ENESTnd study demonstrate higher rates of early and deeper molecular response in newly diagnosed CML patients taking nilotinib, as well as a reduced risk of progression compared to imatinib.

These results were presented at the 2013 ASH Annual Meeting as abstract 92.

“These new, updated data reaffirm the superiority of nilotinib over imatinib at achieving deeper molecular responses and provide even more evidence supporting nilotinib as an appropriate treatment of choice in newly diagnosed patients,” said Giuseppe Saglio, MD, of the University of Turin in Italy.

“Now, we are looking at how deeper molecular responses may help guide our approach towards how we treat CML in the future.”

The 5-year ENESTnd data showed that nilotinib can produce superior responses across various Philadelphia chromosome-positive CML patient populations, including newly diagnosed patients. Results showed higher rates of early and deeper sustained molecular response, known as MR4.5.

The difference in the rates of MR4.5 continued to be higher when nilotinib was given at 300 mg or 400 mg twice daily, when compared to imatinib (MR4.5: 6%-10% difference by 1 year, 21%-23% difference by 5 years).

“The most important endpoint is cumulative incidence of MR4.5,” Dr Saglio said. “At 5 years, this is achieved by 54% of those in nilotinib-300-mg group, 52% in the nilotinib-400-mg group, and 31% in the imatinib group. And the curves are still diverging.” 

The data also indicate a trend for higher overall survival and event-free survival rates in patients treated with nilotinib.

Fifteen patients treated with imatinib had CML-related deaths, compared to 6 patients in the arm receiving nilotinib at 300 mg twice daily and 4 patients in the arm receiving nilotinib at 400 mg twice daily.

Few new adverse events and laboratory abnormalities were observed between year 4 and year 5. Rates of patients with adverse events leading to discontinuation were 11.1% in the 300-mg nilotinib group, 17.7% in the 400-mg nilotinib group, and 13.2% in the imatinib group.

Dr Saglio noted that select cardiac and vascular events are slightly more frequent on nilotinib versus imatinib. But there has been no increase in the annual incidence of these events over time.

Therefore, Dr Saglio concluded, “Nilotinib, a standard-of-care frontline therapy option for newly diagnosed, chronic-phase CML patients, affords superior efficacy compared with imatinib, including higher rates of early molecular response (which is associated with improved long-term outcomes), higher rates of deep molecular response, and a lower risk of disease progression. Nilotinib continues to show good tolerability with long-term follow-up.”

Prescriptions
Credit: CDC

NEW ORLEANS—New data indicate a trend for longer overall survival and event-free survival in newly diagnosed chronic myeloid leukemia (CML) patients on nilotinib versus imatinib.

Five-year data from the phase 3 ENESTnd study demonstrate higher rates of early and deeper molecular response in newly diagnosed CML patients taking nilotinib, as well as a reduced risk of progression compared to imatinib.

These results were presented at the 2013 ASH Annual Meeting as abstract 92.

“These new, updated data reaffirm the superiority of nilotinib over imatinib at achieving deeper molecular responses and provide even more evidence supporting nilotinib as an appropriate treatment of choice in newly diagnosed patients,” said Giuseppe Saglio, MD, of the University of Turin in Italy.

“Now, we are looking at how deeper molecular responses may help guide our approach towards how we treat CML in the future.”

The 5-year ENESTnd data showed that nilotinib can produce superior responses across various Philadelphia chromosome-positive CML patient populations, including newly diagnosed patients. Results showed higher rates of early and deeper sustained molecular response, known as MR4.5.

The difference in the rates of MR4.5 continued to be higher when nilotinib was given at 300 mg or 400 mg twice daily, when compared to imatinib (MR4.5: 6%-10% difference by 1 year, 21%-23% difference by 5 years).

“The most important endpoint is cumulative incidence of MR4.5,” Dr Saglio said. “At 5 years, this is achieved by 54% of those in nilotinib-300-mg group, 52% in the nilotinib-400-mg group, and 31% in the imatinib group. And the curves are still diverging.” 

The data also indicate a trend for higher overall survival and event-free survival rates in patients treated with nilotinib.

Fifteen patients treated with imatinib had CML-related deaths, compared to 6 patients in the arm receiving nilotinib at 300 mg twice daily and 4 patients in the arm receiving nilotinib at 400 mg twice daily.

Few new adverse events and laboratory abnormalities were observed between year 4 and year 5. Rates of patients with adverse events leading to discontinuation were 11.1% in the 300-mg nilotinib group, 17.7% in the 400-mg nilotinib group, and 13.2% in the imatinib group.

Dr Saglio noted that select cardiac and vascular events are slightly more frequent on nilotinib versus imatinib. But there has been no increase in the annual incidence of these events over time.

Therefore, Dr Saglio concluded, “Nilotinib, a standard-of-care frontline therapy option for newly diagnosed, chronic-phase CML patients, affords superior efficacy compared with imatinib, including higher rates of early molecular response (which is associated with improved long-term outcomes), higher rates of deep molecular response, and a lower risk of disease progression. Nilotinib continues to show good tolerability with long-term follow-up.”

Clinical question

What type of venous access -- central or peripheral -- is better for patients in the intensive care unit who have no absolute indication for central access?

Bottom line

As compared with central venous catheters (CVCs), the initial use of peripheral venous catheters (PVCs) in patients in the intensive care unit (ICU) leads to more complications, primarily related to the difficulty in inserting of these catheters. Furthermore, the majority of patients in the PVC group may eventually require a CVC because of an increase in the rate of venotoxic drug infusions or because they have difficulty maintaining the PVC. (LOE = 1b-)

Reference

Ricard J, Salomon L, Boyer A, et al. Central or peripheral catheters for initial venous access of ICU patients. Crit Care Med 2013;41(9):2108-2115.

Study design

Randomized controlled trial (nonblinded)

Funding source

Government

Allocation

Concealed

Setting

Inpatient (ICU only)

Synopsis

Using concealed allocation, these investigators randomized ICU patients requiring venous access to receive either a CVC or PVC. Only patients without any absolute indications for CVCs were included. CVCs could be inserted into jugular, subclavian, or femoral sites at the discretion of the clinician. PVCs were 18-gauge or 20-gauge short catheters. Patients with a predefined increase in the rate of venotoxic drug infusions or those with difficulty maintaining a PVC were able to cross-over to the CVC group. More than half the patients in the PVC group ultimately received a CVC. Baseline characteristics were comparable between the 2 groups, with a mean age of 64 years, similar predicted mortality scores, and the majority of patients requiring mechanical ventilation. The primary outcome was the number of catheter-related complications defined as major mechanical, maintenance-related, infectious, or thrombotic complications. The determination of what constituted a major or minor complication was made a priori by the investigators. They also used a validated classification system of adverse events that rated the complications from grade 1 (minimal symptoms) to grade 5 (death). For example, one major mechanical CVC complication was the need to change insertion site, whereas a major mechanical PVC complication was needing more than 5 attempts to place a PVC. Overall, the PVC group had a greater number of major complications (133 vs 87; P = .02), the majority of which were PVC insertion difficulties (n = 56), erythema at insertion site (n = 20), and subcutaneous diffusion (n = 19). None were life threatening. When the complications were categorized using the grading classification, there were again more complications per patient in the PVC group (1.54 vs 0.89; P = .0001), mainly due to a larger number of grade 1 and grade 2 complications. Finally, more time was spent by doctors and nurses in managing catheters in the PVC group.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

What type of venous access -- central or peripheral -- is better for patients in the intensive care unit who have no absolute indication for central access?

Bottom line

As compared with central venous catheters (CVCs), the initial use of peripheral venous catheters (PVCs) in patients in the intensive care unit (ICU) leads to more complications, primarily related to the difficulty in inserting of these catheters. Furthermore, the majority of patients in the PVC group may eventually require a CVC because of an increase in the rate of venotoxic drug infusions or because they have difficulty maintaining the PVC. (LOE = 1b-)

Reference

Ricard J, Salomon L, Boyer A, et al. Central or peripheral catheters for initial venous access of ICU patients. Crit Care Med 2013;41(9):2108-2115.

Study design

Randomized controlled trial (nonblinded)

Funding source

Government

Allocation

Concealed

Setting

Inpatient (ICU only)

Synopsis

Using concealed allocation, these investigators randomized ICU patients requiring venous access to receive either a CVC or PVC. Only patients without any absolute indications for CVCs were included. CVCs could be inserted into jugular, subclavian, or femoral sites at the discretion of the clinician. PVCs were 18-gauge or 20-gauge short catheters. Patients with a predefined increase in the rate of venotoxic drug infusions or those with difficulty maintaining a PVC were able to cross-over to the CVC group. More than half the patients in the PVC group ultimately received a CVC. Baseline characteristics were comparable between the 2 groups, with a mean age of 64 years, similar predicted mortality scores, and the majority of patients requiring mechanical ventilation. The primary outcome was the number of catheter-related complications defined as major mechanical, maintenance-related, infectious, or thrombotic complications. The determination of what constituted a major or minor complication was made a priori by the investigators. They also used a validated classification system of adverse events that rated the complications from grade 1 (minimal symptoms) to grade 5 (death). For example, one major mechanical CVC complication was the need to change insertion site, whereas a major mechanical PVC complication was needing more than 5 attempts to place a PVC. Overall, the PVC group had a greater number of major complications (133 vs 87; P = .02), the majority of which were PVC insertion difficulties (n = 56), erythema at insertion site (n = 20), and subcutaneous diffusion (n = 19). None were life threatening. When the complications were categorized using the grading classification, there were again more complications per patient in the PVC group (1.54 vs 0.89; P = .0001), mainly due to a larger number of grade 1 and grade 2 complications. Finally, more time was spent by doctors and nurses in managing catheters in the PVC group.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

What type of venous access -- central or peripheral -- is better for patients in the intensive care unit who have no absolute indication for central access?

Bottom line

As compared with central venous catheters (CVCs), the initial use of peripheral venous catheters (PVCs) in patients in the intensive care unit (ICU) leads to more complications, primarily related to the difficulty in inserting of these catheters. Furthermore, the majority of patients in the PVC group may eventually require a CVC because of an increase in the rate of venotoxic drug infusions or because they have difficulty maintaining the PVC. (LOE = 1b-)

Reference

Ricard J, Salomon L, Boyer A, et al. Central or peripheral catheters for initial venous access of ICU patients. Crit Care Med 2013;41(9):2108-2115.

Study design

Randomized controlled trial (nonblinded)

Funding source

Government

Allocation

Concealed

Setting

Inpatient (ICU only)

Synopsis

Using concealed allocation, these investigators randomized ICU patients requiring venous access to receive either a CVC or PVC. Only patients without any absolute indications for CVCs were included. CVCs could be inserted into jugular, subclavian, or femoral sites at the discretion of the clinician. PVCs were 18-gauge or 20-gauge short catheters. Patients with a predefined increase in the rate of venotoxic drug infusions or those with difficulty maintaining a PVC were able to cross-over to the CVC group. More than half the patients in the PVC group ultimately received a CVC. Baseline characteristics were comparable between the 2 groups, with a mean age of 64 years, similar predicted mortality scores, and the majority of patients requiring mechanical ventilation. The primary outcome was the number of catheter-related complications defined as major mechanical, maintenance-related, infectious, or thrombotic complications. The determination of what constituted a major or minor complication was made a priori by the investigators. They also used a validated classification system of adverse events that rated the complications from grade 1 (minimal symptoms) to grade 5 (death). For example, one major mechanical CVC complication was the need to change insertion site, whereas a major mechanical PVC complication was needing more than 5 attempts to place a PVC. Overall, the PVC group had a greater number of major complications (133 vs 87; P = .02), the majority of which were PVC insertion difficulties (n = 56), erythema at insertion site (n = 20), and subcutaneous diffusion (n = 19). None were life threatening. When the complications were categorized using the grading classification, there were again more complications per patient in the PVC group (1.54 vs 0.89; P = .0001), mainly due to a larger number of grade 1 and grade 2 complications. Finally, more time was spent by doctors and nurses in managing catheters in the PVC group.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

Does the addition of colchicine improve outcomes in the treatment of an initial episode of acute pericarditis?

Bottom line

When used in addition to conventional anti-inflammatory therapy, colchicine decreases the rate of incessant or recurrent pericarditis. You would need to treat 4 patients with colchicine to prevent one such episode. (LOE = 1b)

Reference

Imazio M, Brucato A, Cemin R, et al, for the ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med 2013;369(16):1522-1528.

Study design

Randomized controlled trial (double-blinded)

Funding source

Government

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

Colchicine has been previously shown effective in the prevention of recurrent pericarditis (Daily POEM 12-16-2011). In this study, patients with a first episode of acute pericarditis were randomized to receive either colchicine (0.5 mg - 1 mg daily for 3 months; n = 120) or matching placebo (n = 120). All patients also received conventional treatment for acute pericarditis, either aspirin 800 mg or ibuprofen 600 mg every 8 hours for 7 to 10 days, followed by a taper, or (for those with contraindications to aspirin or ibuprofen) glucorticoid therapy for 2 weeks, followed by a taper. Baseline characteristics in the 2 groups were similar: mean age was 52 years, 60% were male, and the most common cause of pericarditis was idiopathic. The majority of patients received aspirin rather than ibuprofen or glucocorticoids as concomitant therapy. Adherence to the study drug was higher than 95% and did not differ between the 2 groups. Patients were followed up for a mean of 22 months and none were lost to follow-up. Analysis was by intention to treat. The primary outcome of incessant or recurrent pericarditis was decreased in the colchicine group as compared with the placebo group (16.7% vs 37.5%; relative risk = 0.56; 95% CI, 0.30-0.72; P < .001). In addition, the colchicine group had significantly better outcomes with regard to the number of patients with persistent symptoms at 72 hours (19% vs 40%), rate of remission within 1 week (85% vs 58%), time to first recurrence (25 weeks vs 18 weeks), and rate of percarditis-related hospitalizations (5% vs 14%). There was no difference in either overall side effects or gastrointestinal side effects between the 2 groups.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

Does the addition of colchicine improve outcomes in the treatment of an initial episode of acute pericarditis?

Bottom line

When used in addition to conventional anti-inflammatory therapy, colchicine decreases the rate of incessant or recurrent pericarditis. You would need to treat 4 patients with colchicine to prevent one such episode. (LOE = 1b)

Reference

Imazio M, Brucato A, Cemin R, et al, for the ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med 2013;369(16):1522-1528.

Study design

Randomized controlled trial (double-blinded)

Funding source

Government

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

Colchicine has been previously shown effective in the prevention of recurrent pericarditis (Daily POEM 12-16-2011). In this study, patients with a first episode of acute pericarditis were randomized to receive either colchicine (0.5 mg - 1 mg daily for 3 months; n = 120) or matching placebo (n = 120). All patients also received conventional treatment for acute pericarditis, either aspirin 800 mg or ibuprofen 600 mg every 8 hours for 7 to 10 days, followed by a taper, or (for those with contraindications to aspirin or ibuprofen) glucorticoid therapy for 2 weeks, followed by a taper. Baseline characteristics in the 2 groups were similar: mean age was 52 years, 60% were male, and the most common cause of pericarditis was idiopathic. The majority of patients received aspirin rather than ibuprofen or glucocorticoids as concomitant therapy. Adherence to the study drug was higher than 95% and did not differ between the 2 groups. Patients were followed up for a mean of 22 months and none were lost to follow-up. Analysis was by intention to treat. The primary outcome of incessant or recurrent pericarditis was decreased in the colchicine group as compared with the placebo group (16.7% vs 37.5%; relative risk = 0.56; 95% CI, 0.30-0.72; P < .001). In addition, the colchicine group had significantly better outcomes with regard to the number of patients with persistent symptoms at 72 hours (19% vs 40%), rate of remission within 1 week (85% vs 58%), time to first recurrence (25 weeks vs 18 weeks), and rate of percarditis-related hospitalizations (5% vs 14%). There was no difference in either overall side effects or gastrointestinal side effects between the 2 groups.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

Clinical question

Does the addition of colchicine improve outcomes in the treatment of an initial episode of acute pericarditis?

Bottom line

When used in addition to conventional anti-inflammatory therapy, colchicine decreases the rate of incessant or recurrent pericarditis. You would need to treat 4 patients with colchicine to prevent one such episode. (LOE = 1b)

Reference

Imazio M, Brucato A, Cemin R, et al, for the ICAP Investigators. A randomized trial of colchicine for acute pericarditis. N Engl J Med 2013;369(16):1522-1528.

Study design

Randomized controlled trial (double-blinded)

Funding source

Government

Concealed

Setting

Inpatient (any location) with outpatient follow-up

Synopsis

Colchicine has been previously shown effective in the prevention of recurrent pericarditis (Daily POEM 12-16-2011). In this study, patients with a first episode of acute pericarditis were randomized to receive either colchicine (0.5 mg - 1 mg daily for 3 months; n = 120) or matching placebo (n = 120). All patients also received conventional treatment for acute pericarditis, either aspirin 800 mg or ibuprofen 600 mg every 8 hours for 7 to 10 days, followed by a taper, or (for those with contraindications to aspirin or ibuprofen) glucorticoid therapy for 2 weeks, followed by a taper. Baseline characteristics in the 2 groups were similar: mean age was 52 years, 60% were male, and the most common cause of pericarditis was idiopathic. The majority of patients received aspirin rather than ibuprofen or glucocorticoids as concomitant therapy. Adherence to the study drug was higher than 95% and did not differ between the 2 groups. Patients were followed up for a mean of 22 months and none were lost to follow-up. Analysis was by intention to treat. The primary outcome of incessant or recurrent pericarditis was decreased in the colchicine group as compared with the placebo group (16.7% vs 37.5%; relative risk = 0.56; 95% CI, 0.30-0.72; P < .001). In addition, the colchicine group had significantly better outcomes with regard to the number of patients with persistent symptoms at 72 hours (19% vs 40%), rate of remission within 1 week (85% vs 58%), time to first recurrence (25 weeks vs 18 weeks), and rate of percarditis-related hospitalizations (5% vs 14%). There was no difference in either overall side effects or gastrointestinal side effects between the 2 groups.

Dr. Kulkarni is an assistant professor of hospital medicine at Northwestern University in Chicago.

First the good news: According to a study commissioned by the Centers for Disease Control and Prevention and published in JAMA Pediatrics on Dec. 5, measles was officially eliminated in the United States in 2000, and that elimination persisted until 2011. This shows that the vaccine, first approved in 1963, has been effective at "eliminating" the disease, defined as the absence of endemic disease transmission.

This is no small feat. Measles is highly contagious, and prior to 1963, resulted in about 500 deaths per year in the United States, and tens of thousands of hospitalizations. Because it’s so highly contagious, vaccinating a large chunk of susceptible patients was the only way to effectively combat the disease. The "elimination" of the disease marks the success of vaccination strategies. Globally, there are now 500,000 fewer deaths per year from measles than there were a decade ago. If we continue with vaccination programs as we do, there is a chance we can eradicate the disease (JAMA Pediatrics 2013 [doi:10.1001/jamapediatrics.2013.4342]).

Now the bad news: This year, according to a statement that the CDC put out on Dec. 5, there have been 175 cases of measles. This is three times the annual median number of about 60. These cases have been concentrated in communities that are against vaccination, usually brought in from other places where antivaccination sentiments are also high, like Europe, or where vaccination strategies are lagging, like the developing world.

In a well-publicized outbreak in Texas in August, 21 unvaccinated people belonging to the Eagle Mountain International Church contracted the disease when an unvaccinated man travelled to Indonesia and came back ill. The pastor, Terri Copeland Pearsons, daughter of a televangelist Kenneth Copeland, clarifies that she is not against vaccinations but she has reservations about them. "The concerns we have had are primarily with very young children who have family history of autism and with bundling too many immunizations at one time."

Ms. Pearsons further says: "the facts are the facts, but then we know the truth. That always overcomes facts." When did fact become the enemy? How does faith trump science? Why do people treat science with such skepticism, and yet take anecdotes as gospel truth? How is it that despite the best efforts of infectious disease and pediatric societies to dispel such mistaken notions, these ideas survive?

In studies exploring the psychology of vaccine refusal, the factors that parents take into consideration include, but are not limited to, the perceptions of vulnerability of the children, severity of the disease, and safety of the vaccine.

People have forgotten just how severe measles can be. In addition, the unfounded belief that the vaccine can cause autism has just taken on a life of its own, given credibility by celebrities.

I understand that for some people anecdotes often tell a more powerful story than data does. So here’s one anecdote from the personal anecdote library of a doctor from a developing country.

I knew Albert through mutual friends. He played bass in a rock band, belonged to a fraternity in medical school, was involved in intramural basketball, and was in a loving relationship. By the time we graduated from medical school, he was the proud father of a baby girl.

But then things seemed to fall out of place. He failed the medical boards. He uncharacteristically sank into a deep depression that was so severe that he required inpatient treatment, and even then the treatments were not working. Still the assumption was that he had depression from his life’s circumstances.

And then he had a seizure.

That was when the diagnosis of subacute sclerosing panencephalitis, or SSPE, was made. It explained the personality change, intellectual difficulty, and seizures. He had contracted measles 10 years earlier, and this is a known complication of measles, one that hospitals in the Philippines are unfortunately all too familiar with. He died within a few weeks of diagnosis.

Society has forgotten how severe measles can be. We have an effective vaccine and effective global vaccination programs. We therefore have a chance to eradicate this disease altogether, like we did with smallpox and like we’re trying to do with polio. One parent’s strongly held but erroneous beliefs can cause trouble for large segments of the population. Ignoring the antivaccination rhetoric won’t make it go away.

Dr. Chan practices rheumatology in Pawtucket, R.I.

First the good news: According to a study commissioned by the Centers for Disease Control and Prevention and published in JAMA Pediatrics on Dec. 5, measles was officially eliminated in the United States in 2000, and that elimination persisted until 2011. This shows that the vaccine, first approved in 1963, has been effective at "eliminating" the disease, defined as the absence of endemic disease transmission.

This is no small feat. Measles is highly contagious, and prior to 1963, resulted in about 500 deaths per year in the United States, and tens of thousands of hospitalizations. Because it’s so highly contagious, vaccinating a large chunk of susceptible patients was the only way to effectively combat the disease. The "elimination" of the disease marks the success of vaccination strategies. Globally, there are now 500,000 fewer deaths per year from measles than there were a decade ago. If we continue with vaccination programs as we do, there is a chance we can eradicate the disease (JAMA Pediatrics 2013 [doi:10.1001/jamapediatrics.2013.4342]).

Now the bad news: This year, according to a statement that the CDC put out on Dec. 5, there have been 175 cases of measles. This is three times the annual median number of about 60. These cases have been concentrated in communities that are against vaccination, usually brought in from other places where antivaccination sentiments are also high, like Europe, or where vaccination strategies are lagging, like the developing world.

In a well-publicized outbreak in Texas in August, 21 unvaccinated people belonging to the Eagle Mountain International Church contracted the disease when an unvaccinated man travelled to Indonesia and came back ill. The pastor, Terri Copeland Pearsons, daughter of a televangelist Kenneth Copeland, clarifies that she is not against vaccinations but she has reservations about them. "The concerns we have had are primarily with very young children who have family history of autism and with bundling too many immunizations at one time."

Ms. Pearsons further says: "the facts are the facts, but then we know the truth. That always overcomes facts." When did fact become the enemy? How does faith trump science? Why do people treat science with such skepticism, and yet take anecdotes as gospel truth? How is it that despite the best efforts of infectious disease and pediatric societies to dispel such mistaken notions, these ideas survive?

In studies exploring the psychology of vaccine refusal, the factors that parents take into consideration include, but are not limited to, the perceptions of vulnerability of the children, severity of the disease, and safety of the vaccine.

People have forgotten just how severe measles can be. In addition, the unfounded belief that the vaccine can cause autism has just taken on a life of its own, given credibility by celebrities.

I understand that for some people anecdotes often tell a more powerful story than data does. So here’s one anecdote from the personal anecdote library of a doctor from a developing country.

I knew Albert through mutual friends. He played bass in a rock band, belonged to a fraternity in medical school, was involved in intramural basketball, and was in a loving relationship. By the time we graduated from medical school, he was the proud father of a baby girl.

But then things seemed to fall out of place. He failed the medical boards. He uncharacteristically sank into a deep depression that was so severe that he required inpatient treatment, and even then the treatments were not working. Still the assumption was that he had depression from his life’s circumstances.

And then he had a seizure.

That was when the diagnosis of subacute sclerosing panencephalitis, or SSPE, was made. It explained the personality change, intellectual difficulty, and seizures. He had contracted measles 10 years earlier, and this is a known complication of measles, one that hospitals in the Philippines are unfortunately all too familiar with. He died within a few weeks of diagnosis.

Society has forgotten how severe measles can be. We have an effective vaccine and effective global vaccination programs. We therefore have a chance to eradicate this disease altogether, like we did with smallpox and like we’re trying to do with polio. One parent’s strongly held but erroneous beliefs can cause trouble for large segments of the population. Ignoring the antivaccination rhetoric won’t make it go away.

Dr. Chan practices rheumatology in Pawtucket, R.I.

First the good news: According to a study commissioned by the Centers for Disease Control and Prevention and published in JAMA Pediatrics on Dec. 5, measles was officially eliminated in the United States in 2000, and that elimination persisted until 2011. This shows that the vaccine, first approved in 1963, has been effective at "eliminating" the disease, defined as the absence of endemic disease transmission.

This is no small feat. Measles is highly contagious, and prior to 1963, resulted in about 500 deaths per year in the United States, and tens of thousands of hospitalizations. Because it’s so highly contagious, vaccinating a large chunk of susceptible patients was the only way to effectively combat the disease. The "elimination" of the disease marks the success of vaccination strategies. Globally, there are now 500,000 fewer deaths per year from measles than there were a decade ago. If we continue with vaccination programs as we do, there is a chance we can eradicate the disease (JAMA Pediatrics 2013 [doi:10.1001/jamapediatrics.2013.4342]).

Now the bad news: This year, according to a statement that the CDC put out on Dec. 5, there have been 175 cases of measles. This is three times the annual median number of about 60. These cases have been concentrated in communities that are against vaccination, usually brought in from other places where antivaccination sentiments are also high, like Europe, or where vaccination strategies are lagging, like the developing world.

In a well-publicized outbreak in Texas in August, 21 unvaccinated people belonging to the Eagle Mountain International Church contracted the disease when an unvaccinated man travelled to Indonesia and came back ill. The pastor, Terri Copeland Pearsons, daughter of a televangelist Kenneth Copeland, clarifies that she is not against vaccinations but she has reservations about them. "The concerns we have had are primarily with very young children who have family history of autism and with bundling too many immunizations at one time."

Ms. Pearsons further says: "the facts are the facts, but then we know the truth. That always overcomes facts." When did fact become the enemy? How does faith trump science? Why do people treat science with such skepticism, and yet take anecdotes as gospel truth? How is it that despite the best efforts of infectious disease and pediatric societies to dispel such mistaken notions, these ideas survive?

In studies exploring the psychology of vaccine refusal, the factors that parents take into consideration include, but are not limited to, the perceptions of vulnerability of the children, severity of the disease, and safety of the vaccine.

People have forgotten just how severe measles can be. In addition, the unfounded belief that the vaccine can cause autism has just taken on a life of its own, given credibility by celebrities.

I understand that for some people anecdotes often tell a more powerful story than data does. So here’s one anecdote from the personal anecdote library of a doctor from a developing country.

I knew Albert through mutual friends. He played bass in a rock band, belonged to a fraternity in medical school, was involved in intramural basketball, and was in a loving relationship. By the time we graduated from medical school, he was the proud father of a baby girl.

But then things seemed to fall out of place. He failed the medical boards. He uncharacteristically sank into a deep depression that was so severe that he required inpatient treatment, and even then the treatments were not working. Still the assumption was that he had depression from his life’s circumstances.

And then he had a seizure.

That was when the diagnosis of subacute sclerosing panencephalitis, or SSPE, was made. It explained the personality change, intellectual difficulty, and seizures. He had contracted measles 10 years earlier, and this is a known complication of measles, one that hospitals in the Philippines are unfortunately all too familiar with. He died within a few weeks of diagnosis.

Society has forgotten how severe measles can be. We have an effective vaccine and effective global vaccination programs. We therefore have a chance to eradicate this disease altogether, like we did with smallpox and like we’re trying to do with polio. One parent’s strongly held but erroneous beliefs can cause trouble for large segments of the population. Ignoring the antivaccination rhetoric won’t make it go away.

Dr. Chan practices rheumatology in Pawtucket, R.I.

Over the last 2 decades, abundant data on the reproductive safety of medications used to treat psychiatric disorders have become available, filling in many gaps with respect to our knowledge about the safety of commonly used psychiatric medications during pregnancy. But the availability of such safety data with respect to the use of these agents during breastfeeding is less complete.

Because of fears of potential adverse effects on infants associated with psychotropic drug use during lactation, many women with a psychiatric disorder who are treated with a range of psychiatric medications are advised not to breastfeed; or if they choose to breastfeed, they are counseled to avoid taking the essential medication that has made them well. This has been a somewhat intuitive, cautious approach. However, in my 25 years of clinical experience taking care of pregnant and postpartum women with a range of psychiatric disorders, one sad scenario I have frequently witnessed is the woman who decides to defer pharmacologic treatment for severe postpartum psychiatric illness after being counseled to defer treatment given a wish to breastfeed. Those women often have been psychiatrically ill for months while breastfeeding after having decided to defer their own treatment because they do not want to expose the baby to even scant amounts of medication secreted into breast milk associated with use of a needed medicine during lactation.

In a recently published clinical report from the American Academy of Pediatrics committee on drugs, authors suggest that advice not to breastfeed or to uniformly avoid medications while nursing because of possible adverse effects in the infant is often not evidence based and may not be necessary in many cases. The committee states that most drugs do not pose a risk to the mother or infant who is nursing, and that "the benefits of breastfeeding outweigh the risks of exposure to most therapeutic agents via human breast milk" (Pediatrics 2013;132:e796-e809).

The report points out that for certain drugs, a careful risk-benefit analysis is needed, especially for drugs that are concentrated in human milk, those with unproven benefits, and those with long half-lives. Importantly, the report notes say that decisions about the use of medications during lactation have to be made on a case-by-case basis. A concrete example would be exercising appropriate vigilance about the use of these medicines in premature infants with immature metabolism.

The report, published on-line in Pediatrics in August 2013, includes a section on antidepressants, anxiolytics, and antipsychotics. As a resource for clinicians, the report highlights LactMed, part of the National Library of Medicine’s toxicology data network (TOXNET), which provides real-time updated scientific information on the excretion of drugs into breast milk.

The report makes the important distinction regarding the range of clinical decisions that get made in the context of different clinical situations. For example, at our center, patients frequently present with questions about whether to use psychiatric medications while breastfeeding when these women have already been taking the medication during pregnancy for treatment of underlying psychiatric disorder. Others make queries about introduction of pharmacologic therapy in the early postpartum period in the context, for example, of new-onset postpartum depression. Specifically, a woman with a history of psychiatric disorder who is treated with antidepressant during pregnancy may continue that medication across the postpartum period to attenuate risk for postpartum depression, particularly if she has a history of recurrent disease, or depressive relapse when medication has been discontinued. That is clinical scenario differs from that of a woman who develops new onset of depression during the postpartum period.

One part of the AAP report addresses use of certain psychiatric medications in the context of available information from the literature regarding extent of excretion of these medications into breast milk. This section states that many antianxiety drugs, antidepressants, and mood stabilizers are excreted in low concentrations into human milk, with the estimated infant doses under 2% of the weight-adjusted maternal dose. However, the authors also cite small series or case reports where infant plasma levels of some drugs were reported to exceed 10% of maternal plasma concentrations. They list 13 such drugs, which include selective serotonin reuptake inhibitors (SSRIs), antipsychotics, anxiolytics, and mood stabilizers. It is important to keep in mind that the number of these cases is small and represent a very small proportion of cases, when the total denominator of reports in the literature of psychotropic drug use during lactation is considered. For example, olanzapine, a second generation antipsychotic is highlighted as an agent of concern based on one case report (J. Psychopharmacol. 2010;24:121-3).

The take-home message for the clinician is that all psychotropics are excreted into breast milk, even if quantification of the agents in breast milk or infant plasma reveals relatively scant concentration (J. Clin. Psychiatry 2003;64:73-80). If mom takes the medicine coincident with lactation, baby is exposed. At our center, we are usually reluctant to discontinue a medication such as an atypical antipsychotic to treat bipolar disorder in the postpartum period even if the mom chooses to breastfeed considering the extent to which women with bipolar disorder are at a high risk for relapse during the puerperium.

Ironically, we probably have more information regarding the excretion of antidepressants and drugs such as lamotrigine, used as a mood stabilizer, into breast milk than most medicines women take during the postpartum period, with data over the past 15 years suggesting that these medications, like other medications, are excreted into breast milk and are present in infant plasma in extremely sparse concentrations. It is noteworthy that cases of frank newborn toxicity directly associated with mothers who breastfeed on psychiatric medications are extremely few and far between, and are anecdotal at best. For some context, the literature on the effects of SSRI use during pregnancy is vast and prevalence of use of these medications during pregnancy and the postpartum period is substantial; that being said, reports of adverse effects reported in the babies of women who breastfeed while taking an SSRI are scant and thus at least somewhat reassuring.

And yet, consistently, I have witnessed that psychiatric medications are highlighted in the literature as particular agents of concern when it comes to lactation, compared with other medicines, for which only sparse data are available. Whether this reflects a bias about the necessity of treating psychiatric disorders during the postpartum period is unknown. Certainly, the long-term implications for the infant of exposure to low concentrations of psychiatric and nonpsychiatric medications in the context of breastfeeding exposure have yet to be clarified.

Whether a woman treated with a psychiatric medication during the post partum should breastfeed is a prime example of a clinical scenario in which there is no perfect decision, and we need to make the best decision possible, taking into account the available data, and the mother’s psychiatric disorder and her wishes. Some women may be extremely committed to breastfeeding and may choose to breastfeed, acknowledging some of the unknowns regarding these medications during lactation, while other women consider some of the ambiguity associated with the long-term effects of exposure while lactating and may choose not to breastfeed.

It is noteworthy that the AAP committee on drugs concluded the benefits of breastfeeding outweigh the risk of exposure to most therapeutic agents via human milk. And those at our center would certainly suggest that this is the case for psychiatric medications, particularly those used to sustain postpartum maternal psychiatric well-being, which is so critical. As is the case with any clinical decision, and certainly with respect to the use of psychiatric medications during pregnancy and lactation, the decision to treat is contingent on a careful risk-benefit analysis, where the risks of exposure to a medicine is weighed against the risk of untreated psychiatric illness. Even with the well-documented benefits of breastfeeding, nothing should trump the treatment of postpartum psychiatric illness, even if the cost is deferring breastfeeding. Treatment cannot be deferred because of the impact of untreated maternal psychiatric illness on maternal morbidity and on the development of children.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information about reproductive mental health at www.womensmentalhealth.org. To comment, e-mail him at [email protected]. Dr. Cohen has been a consultant to manufacturers of antidepressants and antipsychotic medications.

Over the last 2 decades, abundant data on the reproductive safety of medications used to treat psychiatric disorders have become available, filling in many gaps with respect to our knowledge about the safety of commonly used psychiatric medications during pregnancy. But the availability of such safety data with respect to the use of these agents during breastfeeding is less complete.

Because of fears of potential adverse effects on infants associated with psychotropic drug use during lactation, many women with a psychiatric disorder who are treated with a range of psychiatric medications are advised not to breastfeed; or if they choose to breastfeed, they are counseled to avoid taking the essential medication that has made them well. This has been a somewhat intuitive, cautious approach. However, in my 25 years of clinical experience taking care of pregnant and postpartum women with a range of psychiatric disorders, one sad scenario I have frequently witnessed is the woman who decides to defer pharmacologic treatment for severe postpartum psychiatric illness after being counseled to defer treatment given a wish to breastfeed. Those women often have been psychiatrically ill for months while breastfeeding after having decided to defer their own treatment because they do not want to expose the baby to even scant amounts of medication secreted into breast milk associated with use of a needed medicine during lactation.

In a recently published clinical report from the American Academy of Pediatrics committee on drugs, authors suggest that advice not to breastfeed or to uniformly avoid medications while nursing because of possible adverse effects in the infant is often not evidence based and may not be necessary in many cases. The committee states that most drugs do not pose a risk to the mother or infant who is nursing, and that "the benefits of breastfeeding outweigh the risks of exposure to most therapeutic agents via human breast milk" (Pediatrics 2013;132:e796-e809).

The report points out that for certain drugs, a careful risk-benefit analysis is needed, especially for drugs that are concentrated in human milk, those with unproven benefits, and those with long half-lives. Importantly, the report notes say that decisions about the use of medications during lactation have to be made on a case-by-case basis. A concrete example would be exercising appropriate vigilance about the use of these medicines in premature infants with immature metabolism.

The report, published on-line in Pediatrics in August 2013, includes a section on antidepressants, anxiolytics, and antipsychotics. As a resource for clinicians, the report highlights LactMed, part of the National Library of Medicine’s toxicology data network (TOXNET), which provides real-time updated scientific information on the excretion of drugs into breast milk.

The report makes the important distinction regarding the range of clinical decisions that get made in the context of different clinical situations. For example, at our center, patients frequently present with questions about whether to use psychiatric medications while breastfeeding when these women have already been taking the medication during pregnancy for treatment of underlying psychiatric disorder. Others make queries about introduction of pharmacologic therapy in the early postpartum period in the context, for example, of new-onset postpartum depression. Specifically, a woman with a history of psychiatric disorder who is treated with antidepressant during pregnancy may continue that medication across the postpartum period to attenuate risk for postpartum depression, particularly if she has a history of recurrent disease, or depressive relapse when medication has been discontinued. That is clinical scenario differs from that of a woman who develops new onset of depression during the postpartum period.

One part of the AAP report addresses use of certain psychiatric medications in the context of available information from the literature regarding extent of excretion of these medications into breast milk. This section states that many antianxiety drugs, antidepressants, and mood stabilizers are excreted in low concentrations into human milk, with the estimated infant doses under 2% of the weight-adjusted maternal dose. However, the authors also cite small series or case reports where infant plasma levels of some drugs were reported to exceed 10% of maternal plasma concentrations. They list 13 such drugs, which include selective serotonin reuptake inhibitors (SSRIs), antipsychotics, anxiolytics, and mood stabilizers. It is important to keep in mind that the number of these cases is small and represent a very small proportion of cases, when the total denominator of reports in the literature of psychotropic drug use during lactation is considered. For example, olanzapine, a second generation antipsychotic is highlighted as an agent of concern based on one case report (J. Psychopharmacol. 2010;24:121-3).

The take-home message for the clinician is that all psychotropics are excreted into breast milk, even if quantification of the agents in breast milk or infant plasma reveals relatively scant concentration (J. Clin. Psychiatry 2003;64:73-80). If mom takes the medicine coincident with lactation, baby is exposed. At our center, we are usually reluctant to discontinue a medication such as an atypical antipsychotic to treat bipolar disorder in the postpartum period even if the mom chooses to breastfeed considering the extent to which women with bipolar disorder are at a high risk for relapse during the puerperium.

Ironically, we probably have more information regarding the excretion of antidepressants and drugs such as lamotrigine, used as a mood stabilizer, into breast milk than most medicines women take during the postpartum period, with data over the past 15 years suggesting that these medications, like other medications, are excreted into breast milk and are present in infant plasma in extremely sparse concentrations. It is noteworthy that cases of frank newborn toxicity directly associated with mothers who breastfeed on psychiatric medications are extremely few and far between, and are anecdotal at best. For some context, the literature on the effects of SSRI use during pregnancy is vast and prevalence of use of these medications during pregnancy and the postpartum period is substantial; that being said, reports of adverse effects reported in the babies of women who breastfeed while taking an SSRI are scant and thus at least somewhat reassuring.

And yet, consistently, I have witnessed that psychiatric medications are highlighted in the literature as particular agents of concern when it comes to lactation, compared with other medicines, for which only sparse data are available. Whether this reflects a bias about the necessity of treating psychiatric disorders during the postpartum period is unknown. Certainly, the long-term implications for the infant of exposure to low concentrations of psychiatric and nonpsychiatric medications in the context of breastfeeding exposure have yet to be clarified.

Whether a woman treated with a psychiatric medication during the post partum should breastfeed is a prime example of a clinical scenario in which there is no perfect decision, and we need to make the best decision possible, taking into account the available data, and the mother’s psychiatric disorder and her wishes. Some women may be extremely committed to breastfeeding and may choose to breastfeed, acknowledging some of the unknowns regarding these medications during lactation, while other women consider some of the ambiguity associated with the long-term effects of exposure while lactating and may choose not to breastfeed.

It is noteworthy that the AAP committee on drugs concluded the benefits of breastfeeding outweigh the risk of exposure to most therapeutic agents via human milk. And those at our center would certainly suggest that this is the case for psychiatric medications, particularly those used to sustain postpartum maternal psychiatric well-being, which is so critical. As is the case with any clinical decision, and certainly with respect to the use of psychiatric medications during pregnancy and lactation, the decision to treat is contingent on a careful risk-benefit analysis, where the risks of exposure to a medicine is weighed against the risk of untreated psychiatric illness. Even with the well-documented benefits of breastfeeding, nothing should trump the treatment of postpartum psychiatric illness, even if the cost is deferring breastfeeding. Treatment cannot be deferred because of the impact of untreated maternal psychiatric illness on maternal morbidity and on the development of children.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information about reproductive mental health at www.womensmentalhealth.org. To comment, e-mail him at [email protected]. Dr. Cohen has been a consultant to manufacturers of antidepressants and antipsychotic medications.

Over the last 2 decades, abundant data on the reproductive safety of medications used to treat psychiatric disorders have become available, filling in many gaps with respect to our knowledge about the safety of commonly used psychiatric medications during pregnancy. But the availability of such safety data with respect to the use of these agents during breastfeeding is less complete.

Because of fears of potential adverse effects on infants associated with psychotropic drug use during lactation, many women with a psychiatric disorder who are treated with a range of psychiatric medications are advised not to breastfeed; or if they choose to breastfeed, they are counseled to avoid taking the essential medication that has made them well. This has been a somewhat intuitive, cautious approach. However, in my 25 years of clinical experience taking care of pregnant and postpartum women with a range of psychiatric disorders, one sad scenario I have frequently witnessed is the woman who decides to defer pharmacologic treatment for severe postpartum psychiatric illness after being counseled to defer treatment given a wish to breastfeed. Those women often have been psychiatrically ill for months while breastfeeding after having decided to defer their own treatment because they do not want to expose the baby to even scant amounts of medication secreted into breast milk associated with use of a needed medicine during lactation.

In a recently published clinical report from the American Academy of Pediatrics committee on drugs, authors suggest that advice not to breastfeed or to uniformly avoid medications while nursing because of possible adverse effects in the infant is often not evidence based and may not be necessary in many cases. The committee states that most drugs do not pose a risk to the mother or infant who is nursing, and that "the benefits of breastfeeding outweigh the risks of exposure to most therapeutic agents via human breast milk" (Pediatrics 2013;132:e796-e809).

The report points out that for certain drugs, a careful risk-benefit analysis is needed, especially for drugs that are concentrated in human milk, those with unproven benefits, and those with long half-lives. Importantly, the report notes say that decisions about the use of medications during lactation have to be made on a case-by-case basis. A concrete example would be exercising appropriate vigilance about the use of these medicines in premature infants with immature metabolism.

The report, published on-line in Pediatrics in August 2013, includes a section on antidepressants, anxiolytics, and antipsychotics. As a resource for clinicians, the report highlights LactMed, part of the National Library of Medicine’s toxicology data network (TOXNET), which provides real-time updated scientific information on the excretion of drugs into breast milk.

The report makes the important distinction regarding the range of clinical decisions that get made in the context of different clinical situations. For example, at our center, patients frequently present with questions about whether to use psychiatric medications while breastfeeding when these women have already been taking the medication during pregnancy for treatment of underlying psychiatric disorder. Others make queries about introduction of pharmacologic therapy in the early postpartum period in the context, for example, of new-onset postpartum depression. Specifically, a woman with a history of psychiatric disorder who is treated with antidepressant during pregnancy may continue that medication across the postpartum period to attenuate risk for postpartum depression, particularly if she has a history of recurrent disease, or depressive relapse when medication has been discontinued. That is clinical scenario differs from that of a woman who develops new onset of depression during the postpartum period.

One part of the AAP report addresses use of certain psychiatric medications in the context of available information from the literature regarding extent of excretion of these medications into breast milk. This section states that many antianxiety drugs, antidepressants, and mood stabilizers are excreted in low concentrations into human milk, with the estimated infant doses under 2% of the weight-adjusted maternal dose. However, the authors also cite small series or case reports where infant plasma levels of some drugs were reported to exceed 10% of maternal plasma concentrations. They list 13 such drugs, which include selective serotonin reuptake inhibitors (SSRIs), antipsychotics, anxiolytics, and mood stabilizers. It is important to keep in mind that the number of these cases is small and represent a very small proportion of cases, when the total denominator of reports in the literature of psychotropic drug use during lactation is considered. For example, olanzapine, a second generation antipsychotic is highlighted as an agent of concern based on one case report (J. Psychopharmacol. 2010;24:121-3).

The take-home message for the clinician is that all psychotropics are excreted into breast milk, even if quantification of the agents in breast milk or infant plasma reveals relatively scant concentration (J. Clin. Psychiatry 2003;64:73-80). If mom takes the medicine coincident with lactation, baby is exposed. At our center, we are usually reluctant to discontinue a medication such as an atypical antipsychotic to treat bipolar disorder in the postpartum period even if the mom chooses to breastfeed considering the extent to which women with bipolar disorder are at a high risk for relapse during the puerperium.

Ironically, we probably have more information regarding the excretion of antidepressants and drugs such as lamotrigine, used as a mood stabilizer, into breast milk than most medicines women take during the postpartum period, with data over the past 15 years suggesting that these medications, like other medications, are excreted into breast milk and are present in infant plasma in extremely sparse concentrations. It is noteworthy that cases of frank newborn toxicity directly associated with mothers who breastfeed on psychiatric medications are extremely few and far between, and are anecdotal at best. For some context, the literature on the effects of SSRI use during pregnancy is vast and prevalence of use of these medications during pregnancy and the postpartum period is substantial; that being said, reports of adverse effects reported in the babies of women who breastfeed while taking an SSRI are scant and thus at least somewhat reassuring.

And yet, consistently, I have witnessed that psychiatric medications are highlighted in the literature as particular agents of concern when it comes to lactation, compared with other medicines, for which only sparse data are available. Whether this reflects a bias about the necessity of treating psychiatric disorders during the postpartum period is unknown. Certainly, the long-term implications for the infant of exposure to low concentrations of psychiatric and nonpsychiatric medications in the context of breastfeeding exposure have yet to be clarified.

Whether a woman treated with a psychiatric medication during the post partum should breastfeed is a prime example of a clinical scenario in which there is no perfect decision, and we need to make the best decision possible, taking into account the available data, and the mother’s psychiatric disorder and her wishes. Some women may be extremely committed to breastfeeding and may choose to breastfeed, acknowledging some of the unknowns regarding these medications during lactation, while other women consider some of the ambiguity associated with the long-term effects of exposure while lactating and may choose not to breastfeed.

It is noteworthy that the AAP committee on drugs concluded the benefits of breastfeeding outweigh the risk of exposure to most therapeutic agents via human milk. And those at our center would certainly suggest that this is the case for psychiatric medications, particularly those used to sustain postpartum maternal psychiatric well-being, which is so critical. As is the case with any clinical decision, and certainly with respect to the use of psychiatric medications during pregnancy and lactation, the decision to treat is contingent on a careful risk-benefit analysis, where the risks of exposure to a medicine is weighed against the risk of untreated psychiatric illness. Even with the well-documented benefits of breastfeeding, nothing should trump the treatment of postpartum psychiatric illness, even if the cost is deferring breastfeeding. Treatment cannot be deferred because of the impact of untreated maternal psychiatric illness on maternal morbidity and on the development of children.

Dr. Cohen is the director of the Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information about reproductive mental health at www.womensmentalhealth.org. To comment, e-mail him at [email protected]. Dr. Cohen has been a consultant to manufacturers of antidepressants and antipsychotic medications.

Hospitalists shouldn't get too excited over the recent decision by the Centers for Medicare & Medicaid Services (CMS) that allows specialty society-run clinical data registries to submit their own quality metrics under the Physician Quality Reporting System (PQRS).

CMS earlier this month agreed to let specialist medical societies draw up their own quality measures, but to qualify, societies must have a certified clinical data registry. SHM’s Public Policy Committee (PPC) and Performance Measurement and Reporting Committee (PMRC) consistently provide feedback to CMS on the current PQRS quality measures and is reviewing the potential value of a clinical data registry for SHM members in the future.

PPC and Team Hospitalist member Joshua Lenchus, DO, RPh, FACP, SFHM, says he and other hospitalist leaders will discuss CMS' decision, but he wonders whether the reporting system's average payment adjustment for foreseeable program years and hospitalist interest is high enough to make establishing a data registry worthwhile. “The question begs,” Dr. Lenchus says, “is the benefit worth the effort?”

The 2014 Medicare physician fee schedule [PDF] reported that 26,515 medical practices with 266,521 eligible professionals participated in PQRS in 2011—or about 27% of eligible providers. SHM has encouraged its members to participate since the system's inception in 2007 to both take advantage of incentive payments that were available and to prepare for upcoming penalties for failure to report. Starting in 2015 and based on 2013 performance, there will be a penalty for not reporting PQRS quality measures.

Dr. Lenchus says PPC members will continue to monitor and advocate for quality metrics that are more in line with daily hospitalist duties. Similarly, SHM's Performance Measurement and Reporting Committee (PMRC) has been working to identify and ensure measures applicable to HM are included in PQRS.

"The committee is deeply concerned about the limited number of PQRS measures broadly applicable to hospitalists, and we are working to change this disparity," wrote Greg Seymann, MD, SFHM, chief of the division of hospital medicine at the University of California at San Diego and chair of SHM’s PMRC, and Josh Boswell, SHM’s senior manager of government relations in The Hospitalist last month.

Dr. Lenchus adds that while SHM and other societies can weigh in on the measures, CMS remains the final arbiter.

"Groups will submit whatever metrics they would like to be assessed against and those metrics will not be taken carte blanche, but rather will require CMS approval," he says.

Visit our website for more information about PQRS.

Hospitalists shouldn't get too excited over the recent decision by the Centers for Medicare & Medicaid Services (CMS) that allows specialty society-run clinical data registries to submit their own quality metrics under the Physician Quality Reporting System (PQRS).

CMS earlier this month agreed to let specialist medical societies draw up their own quality measures, but to qualify, societies must have a certified clinical data registry. SHM’s Public Policy Committee (PPC) and Performance Measurement and Reporting Committee (PMRC) consistently provide feedback to CMS on the current PQRS quality measures and is reviewing the potential value of a clinical data registry for SHM members in the future.

PPC and Team Hospitalist member Joshua Lenchus, DO, RPh, FACP, SFHM, says he and other hospitalist leaders will discuss CMS' decision, but he wonders whether the reporting system's average payment adjustment for foreseeable program years and hospitalist interest is high enough to make establishing a data registry worthwhile. “The question begs,” Dr. Lenchus says, “is the benefit worth the effort?”

The 2014 Medicare physician fee schedule [PDF] reported that 26,515 medical practices with 266,521 eligible professionals participated in PQRS in 2011—or about 27% of eligible providers. SHM has encouraged its members to participate since the system's inception in 2007 to both take advantage of incentive payments that were available and to prepare for upcoming penalties for failure to report. Starting in 2015 and based on 2013 performance, there will be a penalty for not reporting PQRS quality measures.

Dr. Lenchus says PPC members will continue to monitor and advocate for quality metrics that are more in line with daily hospitalist duties. Similarly, SHM's Performance Measurement and Reporting Committee (PMRC) has been working to identify and ensure measures applicable to HM are included in PQRS.

"The committee is deeply concerned about the limited number of PQRS measures broadly applicable to hospitalists, and we are working to change this disparity," wrote Greg Seymann, MD, SFHM, chief of the division of hospital medicine at the University of California at San Diego and chair of SHM’s PMRC, and Josh Boswell, SHM’s senior manager of government relations in The Hospitalist last month.

Dr. Lenchus adds that while SHM and other societies can weigh in on the measures, CMS remains the final arbiter.

"Groups will submit whatever metrics they would like to be assessed against and those metrics will not be taken carte blanche, but rather will require CMS approval," he says.

Visit our website for more information about PQRS.

Hospitalists shouldn't get too excited over the recent decision by the Centers for Medicare & Medicaid Services (CMS) that allows specialty society-run clinical data registries to submit their own quality metrics under the Physician Quality Reporting System (PQRS).

CMS earlier this month agreed to let specialist medical societies draw up their own quality measures, but to qualify, societies must have a certified clinical data registry. SHM’s Public Policy Committee (PPC) and Performance Measurement and Reporting Committee (PMRC) consistently provide feedback to CMS on the current PQRS quality measures and is reviewing the potential value of a clinical data registry for SHM members in the future.

PPC and Team Hospitalist member Joshua Lenchus, DO, RPh, FACP, SFHM, says he and other hospitalist leaders will discuss CMS' decision, but he wonders whether the reporting system's average payment adjustment for foreseeable program years and hospitalist interest is high enough to make establishing a data registry worthwhile. “The question begs,” Dr. Lenchus says, “is the benefit worth the effort?”

The 2014 Medicare physician fee schedule [PDF] reported that 26,515 medical practices with 266,521 eligible professionals participated in PQRS in 2011—or about 27% of eligible providers. SHM has encouraged its members to participate since the system's inception in 2007 to both take advantage of incentive payments that were available and to prepare for upcoming penalties for failure to report. Starting in 2015 and based on 2013 performance, there will be a penalty for not reporting PQRS quality measures.

Dr. Lenchus says PPC members will continue to monitor and advocate for quality metrics that are more in line with daily hospitalist duties. Similarly, SHM's Performance Measurement and Reporting Committee (PMRC) has been working to identify and ensure measures applicable to HM are included in PQRS.

"The committee is deeply concerned about the limited number of PQRS measures broadly applicable to hospitalists, and we are working to change this disparity," wrote Greg Seymann, MD, SFHM, chief of the division of hospital medicine at the University of California at San Diego and chair of SHM’s PMRC, and Josh Boswell, SHM’s senior manager of government relations in The Hospitalist last month.

Dr. Lenchus adds that while SHM and other societies can weigh in on the measures, CMS remains the final arbiter.

"Groups will submit whatever metrics they would like to be assessed against and those metrics will not be taken carte blanche, but rather will require CMS approval," he says.

Visit our website for more information about PQRS.

How would hospitalists feel if patients or families asked them to wash their hands when they entered the hospital room? A new campaign called "Infection Prevention and You," engages patients to help hospitals overcome one of the most persistent barriers to preventing hospital-acquired infections (HAIs)—healthcare professionals failing to practice proper hand hygiene.

Launched by the Association for Professionals in Infection Control and Epidemiology (APIC), the organization"s executives contend that everyone plays a role in infection prevention.

"We know that washing hands is important, and so many things have been tried," says Carol McLay, DrPH, MPH, RN, CIC, infection prevention consultant and chair of APIC's Communications Committee. "Patient empowerment is one of the newer approaches. Studies have shown that patients really like the idea, but often are afraid to speak up."

Dr. McLay says hand-washing advocacy is one piece of a larger campaign for preventing HAIs across settings of care.

"I would hope that physicians, including hospitalists, would view it as an opportunity to do the right thing, to serve as effective role models, and to say to their patients, 'Your health is important to me,'" she says.

"The aspiration of having anyone and everyone speak up and ask providers to apply hand hygiene is laudable," says hospitalist Ethan Cumbler, MD, FACP, who has spearheaded a multidisciplinary hand hygiene initiative at University of Colorado Hospital in Aurora. But he says it is naive to expect all providers to respond positively to being corrected in this way. "At first, we may bristle at being challenged on hand hygiene, but when we consider what kind of physicians we want to be, and what kind of culture we want to work in, I believe it is a challenge we will come to appreciate," Dr. Cumbler says.

Visit our website for more information about hospitalists and infection prevention.

How would hospitalists feel if patients or families asked them to wash their hands when they entered the hospital room? A new campaign called "Infection Prevention and You," engages patients to help hospitals overcome one of the most persistent barriers to preventing hospital-acquired infections (HAIs)—healthcare professionals failing to practice proper hand hygiene.

Launched by the Association for Professionals in Infection Control and Epidemiology (APIC), the organization"s executives contend that everyone plays a role in infection prevention.

"We know that washing hands is important, and so many things have been tried," says Carol McLay, DrPH, MPH, RN, CIC, infection prevention consultant and chair of APIC's Communications Committee. "Patient empowerment is one of the newer approaches. Studies have shown that patients really like the idea, but often are afraid to speak up."

Dr. McLay says hand-washing advocacy is one piece of a larger campaign for preventing HAIs across settings of care.

"I would hope that physicians, including hospitalists, would view it as an opportunity to do the right thing, to serve as effective role models, and to say to their patients, 'Your health is important to me,'" she says.

"The aspiration of having anyone and everyone speak up and ask providers to apply hand hygiene is laudable," says hospitalist Ethan Cumbler, MD, FACP, who has spearheaded a multidisciplinary hand hygiene initiative at University of Colorado Hospital in Aurora. But he says it is naive to expect all providers to respond positively to being corrected in this way. "At first, we may bristle at being challenged on hand hygiene, but when we consider what kind of physicians we want to be, and what kind of culture we want to work in, I believe it is a challenge we will come to appreciate," Dr. Cumbler says.

Visit our website for more information about hospitalists and infection prevention.

How would hospitalists feel if patients or families asked them to wash their hands when they entered the hospital room? A new campaign called "Infection Prevention and You," engages patients to help hospitals overcome one of the most persistent barriers to preventing hospital-acquired infections (HAIs)—healthcare professionals failing to practice proper hand hygiene.

Launched by the Association for Professionals in Infection Control and Epidemiology (APIC), the organization"s executives contend that everyone plays a role in infection prevention.

"We know that washing hands is important, and so many things have been tried," says Carol McLay, DrPH, MPH, RN, CIC, infection prevention consultant and chair of APIC's Communications Committee. "Patient empowerment is one of the newer approaches. Studies have shown that patients really like the idea, but often are afraid to speak up."

Dr. McLay says hand-washing advocacy is one piece of a larger campaign for preventing HAIs across settings of care.

"I would hope that physicians, including hospitalists, would view it as an opportunity to do the right thing, to serve as effective role models, and to say to their patients, 'Your health is important to me,'" she says.

"The aspiration of having anyone and everyone speak up and ask providers to apply hand hygiene is laudable," says hospitalist Ethan Cumbler, MD, FACP, who has spearheaded a multidisciplinary hand hygiene initiative at University of Colorado Hospital in Aurora. But he says it is naive to expect all providers to respond positively to being corrected in this way. "At first, we may bristle at being challenged on hand hygiene, but when we consider what kind of physicians we want to be, and what kind of culture we want to work in, I believe it is a challenge we will come to appreciate," Dr. Cumbler says.

Visit our website for more information about hospitalists and infection prevention.