UpToDate, a leading clinical decision support resource for physicians, in July added palliative care as the newest of its 22 medical specialties. The palliative care section covers a variety of topics focused on improving symptoms and providing best quality of life for patients with serious illnesses. The new service resulted from two years of extensive collaboration by a team of 100 leading palliative care specialists from around the world, led by Harvard Medical School palliative care physicians J. Andrew Billings, MD, and Susan D. Block, MD, reviewing and grading the body of research and scientific literature on palliative care.

UpToDate, a leading clinical decision support resource for physicians, in July added palliative care as the newest of its 22 medical specialties. The palliative care section covers a variety of topics focused on improving symptoms and providing best quality of life for patients with serious illnesses. The new service resulted from two years of extensive collaboration by a team of 100 leading palliative care specialists from around the world, led by Harvard Medical School palliative care physicians J. Andrew Billings, MD, and Susan D. Block, MD, reviewing and grading the body of research and scientific literature on palliative care.

UpToDate, a leading clinical decision support resource for physicians, in July added palliative care as the newest of its 22 medical specialties. The palliative care section covers a variety of topics focused on improving symptoms and providing best quality of life for patients with serious illnesses. The new service resulted from two years of extensive collaboration by a team of 100 leading palliative care specialists from around the world, led by Harvard Medical School palliative care physicians J. Andrew Billings, MD, and Susan D. Block, MD, reviewing and grading the body of research and scientific literature on palliative care.

A frequent referral to our pediatric infectious disease outpatient program at Boston Medical Center is the child with recurrent skin and soft tissue infection. Most often, the child is an infant, toddler, or adolescent; the child is otherwise well but has had two or three prior episodes of skin infection; the infections are typically peri-inguinal including the buttocks, but may involve the face, back, thighs, or scalp. The families are often frustrated and hoping for a solution. Are there effective strategies for reducing recurrences?

Several recent studies provide insights and can be helpful in forming an evidence-based approach that offers modest benefit for reducing the risk of recurrence. Most recently, Kaplan et al. (Clin. Inf. Dis. 2014;58:679-82) reported on a clinical trial of sodium hypochlorite bleach baths combined with hygienic measures (frequent hand washing with soap, cutting fingernails short, using towels or washcloths and clothing without sharing, and daily bathing or showering), compared with hygienic measures alone. The treatment group received twice-weekly hypochlorite baths with 5 mL household bleach (Clorox-Regular 6.0% hypochlorite) per gallon of bath water, followed by moisturizer. Most children were colonized with methicillin-resistant Staphylococcus aureus (MRSA)(approximately 70%) or methicillin-susceptible S. aureus (MSSA)(approximately 30%). In the 12-month follow-up, 20% of children had recurrent skin or soft tissue infection (SSTI). Risk factors for recurrence were young age (<6 years) and burden of colonization (number of colonized sites). A small, nonstatistically significant benefit was observed in the treatment group with a 17% incidence of SSTI, compared with 20.9% in controls (P = 0.15). The authors concluded a bleach bath plus hygiene measures was associated with about a 20% nonstatistically significant decrease in recurrent community-acquired SSTI. No adverse effects of bleach baths were identified.

A second open-label, randomized study by Fritz et al. (Clin. Inf. Dis. 2012;54:743-51) evaluated the value of individual decolonization, compared with household decolonization, in children 6 months through 20 years of age with prior community-acquired SSTI. Cases were randomized to individual decolonization regimens (hygiene, 2% mupirocin for 5 days and 4% chlorhexidine daily body washes) or to household decolonization. Staphylococcal colonization was evaluated at 1, 3, 6, and 12 months. No differences in the rate of eradication of S. aureus were observed between the two strategies, except at 3 months where a greater proportion of children randomized to household decolonization were culture negative. Despite the lack of impact on colonization, SSTI documented by a physician was less common in children where decolonization was householdwide. After 12 months, 36% of children in the household decolonization sites had recurrent SSTI, compared with 55% in the individual decolonization stratum (P = .03). The authors concluded that household decolonization reduces SSTI in both the individual and household contacts.

Another approach to decolonization has been the use of oral antibiotics in combination with mupirocin and hexachloradine. Although data are limited, Miller et al. (Antimicrob. Agents Chemother. 2012;56:1084-6) reported on a small cohort of 31 prospectively evaluated patients with recurrent community-acquired MRSA skin infections. Individuals received nasal mupirocin, topical hexachlorophene body wash, and an oral antibiotic based on susceptibility testing (doxycycline, minocycline, or trimethoprim-sulfamethoxazole). In the 6 months prior to enrollment, the mean rate of SSTI was three infections per person (range, 2-30). The mean number of MRSA infections after the intervention decreased significantly from 0.84 infections per month to 0.03 infections per month during the 5.2-month follow-up. In general, the regimens were well tolerated with minor gastrointestinal complaints. The authors concluded that the combination of systemic and topical antimicrobials was associated with subsequent decreases in community-acquired MRSA SSTI; however, they acknowledged that without a control group, they were unable to be certain that the decrease was due to the prescribed regimen.

Our current approach for children referred with recurrent SSTI is household decolonization with nasal mupirocin and daily hexachloradine baths or showers or hypochlorite baths. The mupirocin is prescribed for 5-10 days; the hexachloradine/hypochlorite baths, for several months. We also stress the need for hygiene, including washing towels and linens in hot water, and cleaning surfaces and items such as remote controls with hypochlorite solutions. Although the value of environmental decontamination is unknown, studies by Uhlemann et al. (PLOS ONE 2011;6: e22407) demonstrated excess contamination of household surfaces in homes of SSTI cases. If recurrences continue, the addition of an antimicrobial agent is considered. We reserve doxycycline for children over 8 years of age and prescribe trimethoprim-sulfamethoxazole for those younger than 8 years. We also will ask about pets although we are aware of only anecdotal reports where treating the family dog or cat has aborted recurrent disease in the patients.

 

In summary, recurrent SSTI is common, especially among young children. The burden of colonization appears related to both the risk for recurrent disease and the risk for transmission within the household. Reducing colonization is valuable for decreasing the incidence of recurrent SSTI both for the individual as well as the household members. The current strategies demonstrate modest success, but as many as 30%-40% of patients will continue to have recurrent SSTI. Education about the early signs of infection, early evaluation of SSTI, and appropriate management (topical treatment, incision and drainage, or systemic antibiotics) are successful strategies for limiting progression to invasive staphylococcal disease.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center. Dr. Yildirim is a fellow in pediatric infectious disease and an epidemiologist, at Boston Medical Center. To comment, e-mail Dr. Pelton and Dr. Yildirim at pdnews@frontlinemedcom.com.

A frequent referral to our pediatric infectious disease outpatient program at Boston Medical Center is the child with recurrent skin and soft tissue infection. Most often, the child is an infant, toddler, or adolescent; the child is otherwise well but has had two or three prior episodes of skin infection; the infections are typically peri-inguinal including the buttocks, but may involve the face, back, thighs, or scalp. The families are often frustrated and hoping for a solution. Are there effective strategies for reducing recurrences?

Several recent studies provide insights and can be helpful in forming an evidence-based approach that offers modest benefit for reducing the risk of recurrence. Most recently, Kaplan et al. (Clin. Inf. Dis. 2014;58:679-82) reported on a clinical trial of sodium hypochlorite bleach baths combined with hygienic measures (frequent hand washing with soap, cutting fingernails short, using towels or washcloths and clothing without sharing, and daily bathing or showering), compared with hygienic measures alone. The treatment group received twice-weekly hypochlorite baths with 5 mL household bleach (Clorox-Regular 6.0% hypochlorite) per gallon of bath water, followed by moisturizer. Most children were colonized with methicillin-resistant Staphylococcus aureus (MRSA)(approximately 70%) or methicillin-susceptible S. aureus (MSSA)(approximately 30%). In the 12-month follow-up, 20% of children had recurrent skin or soft tissue infection (SSTI). Risk factors for recurrence were young age (<6 years) and burden of colonization (number of colonized sites). A small, nonstatistically significant benefit was observed in the treatment group with a 17% incidence of SSTI, compared with 20.9% in controls (P = 0.15). The authors concluded a bleach bath plus hygiene measures was associated with about a 20% nonstatistically significant decrease in recurrent community-acquired SSTI. No adverse effects of bleach baths were identified.

A second open-label, randomized study by Fritz et al. (Clin. Inf. Dis. 2012;54:743-51) evaluated the value of individual decolonization, compared with household decolonization, in children 6 months through 20 years of age with prior community-acquired SSTI. Cases were randomized to individual decolonization regimens (hygiene, 2% mupirocin for 5 days and 4% chlorhexidine daily body washes) or to household decolonization. Staphylococcal colonization was evaluated at 1, 3, 6, and 12 months. No differences in the rate of eradication of S. aureus were observed between the two strategies, except at 3 months where a greater proportion of children randomized to household decolonization were culture negative. Despite the lack of impact on colonization, SSTI documented by a physician was less common in children where decolonization was householdwide. After 12 months, 36% of children in the household decolonization sites had recurrent SSTI, compared with 55% in the individual decolonization stratum (P = .03). The authors concluded that household decolonization reduces SSTI in both the individual and household contacts.

Another approach to decolonization has been the use of oral antibiotics in combination with mupirocin and hexachloradine. Although data are limited, Miller et al. (Antimicrob. Agents Chemother. 2012;56:1084-6) reported on a small cohort of 31 prospectively evaluated patients with recurrent community-acquired MRSA skin infections. Individuals received nasal mupirocin, topical hexachlorophene body wash, and an oral antibiotic based on susceptibility testing (doxycycline, minocycline, or trimethoprim-sulfamethoxazole). In the 6 months prior to enrollment, the mean rate of SSTI was three infections per person (range, 2-30). The mean number of MRSA infections after the intervention decreased significantly from 0.84 infections per month to 0.03 infections per month during the 5.2-month follow-up. In general, the regimens were well tolerated with minor gastrointestinal complaints. The authors concluded that the combination of systemic and topical antimicrobials was associated with subsequent decreases in community-acquired MRSA SSTI; however, they acknowledged that without a control group, they were unable to be certain that the decrease was due to the prescribed regimen.

Our current approach for children referred with recurrent SSTI is household decolonization with nasal mupirocin and daily hexachloradine baths or showers or hypochlorite baths. The mupirocin is prescribed for 5-10 days; the hexachloradine/hypochlorite baths, for several months. We also stress the need for hygiene, including washing towels and linens in hot water, and cleaning surfaces and items such as remote controls with hypochlorite solutions. Although the value of environmental decontamination is unknown, studies by Uhlemann et al. (PLOS ONE 2011;6: e22407) demonstrated excess contamination of household surfaces in homes of SSTI cases. If recurrences continue, the addition of an antimicrobial agent is considered. We reserve doxycycline for children over 8 years of age and prescribe trimethoprim-sulfamethoxazole for those younger than 8 years. We also will ask about pets although we are aware of only anecdotal reports where treating the family dog or cat has aborted recurrent disease in the patients.

 

In summary, recurrent SSTI is common, especially among young children. The burden of colonization appears related to both the risk for recurrent disease and the risk for transmission within the household. Reducing colonization is valuable for decreasing the incidence of recurrent SSTI both for the individual as well as the household members. The current strategies demonstrate modest success, but as many as 30%-40% of patients will continue to have recurrent SSTI. Education about the early signs of infection, early evaluation of SSTI, and appropriate management (topical treatment, incision and drainage, or systemic antibiotics) are successful strategies for limiting progression to invasive staphylococcal disease.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center. Dr. Yildirim is a fellow in pediatric infectious disease and an epidemiologist, at Boston Medical Center. To comment, e-mail Dr. Pelton and Dr. Yildirim at pdnews@frontlinemedcom.com.

A frequent referral to our pediatric infectious disease outpatient program at Boston Medical Center is the child with recurrent skin and soft tissue infection. Most often, the child is an infant, toddler, or adolescent; the child is otherwise well but has had two or three prior episodes of skin infection; the infections are typically peri-inguinal including the buttocks, but may involve the face, back, thighs, or scalp. The families are often frustrated and hoping for a solution. Are there effective strategies for reducing recurrences?

Several recent studies provide insights and can be helpful in forming an evidence-based approach that offers modest benefit for reducing the risk of recurrence. Most recently, Kaplan et al. (Clin. Inf. Dis. 2014;58:679-82) reported on a clinical trial of sodium hypochlorite bleach baths combined with hygienic measures (frequent hand washing with soap, cutting fingernails short, using towels or washcloths and clothing without sharing, and daily bathing or showering), compared with hygienic measures alone. The treatment group received twice-weekly hypochlorite baths with 5 mL household bleach (Clorox-Regular 6.0% hypochlorite) per gallon of bath water, followed by moisturizer. Most children were colonized with methicillin-resistant Staphylococcus aureus (MRSA)(approximately 70%) or methicillin-susceptible S. aureus (MSSA)(approximately 30%). In the 12-month follow-up, 20% of children had recurrent skin or soft tissue infection (SSTI). Risk factors for recurrence were young age (<6 years) and burden of colonization (number of colonized sites). A small, nonstatistically significant benefit was observed in the treatment group with a 17% incidence of SSTI, compared with 20.9% in controls (P = 0.15). The authors concluded a bleach bath plus hygiene measures was associated with about a 20% nonstatistically significant decrease in recurrent community-acquired SSTI. No adverse effects of bleach baths were identified.

A second open-label, randomized study by Fritz et al. (Clin. Inf. Dis. 2012;54:743-51) evaluated the value of individual decolonization, compared with household decolonization, in children 6 months through 20 years of age with prior community-acquired SSTI. Cases were randomized to individual decolonization regimens (hygiene, 2% mupirocin for 5 days and 4% chlorhexidine daily body washes) or to household decolonization. Staphylococcal colonization was evaluated at 1, 3, 6, and 12 months. No differences in the rate of eradication of S. aureus were observed between the two strategies, except at 3 months where a greater proportion of children randomized to household decolonization were culture negative. Despite the lack of impact on colonization, SSTI documented by a physician was less common in children where decolonization was householdwide. After 12 months, 36% of children in the household decolonization sites had recurrent SSTI, compared with 55% in the individual decolonization stratum (P = .03). The authors concluded that household decolonization reduces SSTI in both the individual and household contacts.

Another approach to decolonization has been the use of oral antibiotics in combination with mupirocin and hexachloradine. Although data are limited, Miller et al. (Antimicrob. Agents Chemother. 2012;56:1084-6) reported on a small cohort of 31 prospectively evaluated patients with recurrent community-acquired MRSA skin infections. Individuals received nasal mupirocin, topical hexachlorophene body wash, and an oral antibiotic based on susceptibility testing (doxycycline, minocycline, or trimethoprim-sulfamethoxazole). In the 6 months prior to enrollment, the mean rate of SSTI was three infections per person (range, 2-30). The mean number of MRSA infections after the intervention decreased significantly from 0.84 infections per month to 0.03 infections per month during the 5.2-month follow-up. In general, the regimens were well tolerated with minor gastrointestinal complaints. The authors concluded that the combination of systemic and topical antimicrobials was associated with subsequent decreases in community-acquired MRSA SSTI; however, they acknowledged that without a control group, they were unable to be certain that the decrease was due to the prescribed regimen.

Our current approach for children referred with recurrent SSTI is household decolonization with nasal mupirocin and daily hexachloradine baths or showers or hypochlorite baths. The mupirocin is prescribed for 5-10 days; the hexachloradine/hypochlorite baths, for several months. We also stress the need for hygiene, including washing towels and linens in hot water, and cleaning surfaces and items such as remote controls with hypochlorite solutions. Although the value of environmental decontamination is unknown, studies by Uhlemann et al. (PLOS ONE 2011;6: e22407) demonstrated excess contamination of household surfaces in homes of SSTI cases. If recurrences continue, the addition of an antimicrobial agent is considered. We reserve doxycycline for children over 8 years of age and prescribe trimethoprim-sulfamethoxazole for those younger than 8 years. We also will ask about pets although we are aware of only anecdotal reports where treating the family dog or cat has aborted recurrent disease in the patients.

 

In summary, recurrent SSTI is common, especially among young children. The burden of colonization appears related to both the risk for recurrent disease and the risk for transmission within the household. Reducing colonization is valuable for decreasing the incidence of recurrent SSTI both for the individual as well as the household members. The current strategies demonstrate modest success, but as many as 30%-40% of patients will continue to have recurrent SSTI. Education about the early signs of infection, early evaluation of SSTI, and appropriate management (topical treatment, incision and drainage, or systemic antibiotics) are successful strategies for limiting progression to invasive staphylococcal disease.

Dr. Pelton is chief of pediatric infectious disease and coordinator of the maternal-child HIV program at Boston Medical Center. Dr. Yildirim is a fellow in pediatric infectious disease and an epidemiologist, at Boston Medical Center. To comment, e-mail Dr. Pelton and Dr. Yildirim at pdnews@frontlinemedcom.com.

Hospitals and Health Networks in July presented its 16^th annual list of Most Wired Hospitals and Health Systems. Rigorous criteria were used to identify 375 hospitals that use technology to link up disparate care providers and patients. "Most Wired" hospitals are more likely to share critical information electronically with specialists, to use bar codes for matching medications to patients at the bedside, to use IT to reduce the likelihood of medical errors, to better manage care transitions, and to adopt and meaningfully use certified electronic health records.

Meanwhile, Eric Wicklund, editor of mHealth News, called for nominations of the best wireless hospitals, which are moving toward a wireless landscape for mobile health technology and engaging an ever more connected consumer population.

“I’ve already got a few on my own list,” he writes, asking his readers to submit examples of programs and projects that are doing it right and using mobile health to make a difference.

MHADegree.org, a resource for students and professionals in health administration, named the top 50 most social media-friendly hospitals for 2013, led by Mayo Clinic in Rochester, Minn., and Cleveland Clinic in Cleveland, Ohio.

Hospitals and Health Networks in July presented its 16^th annual list of Most Wired Hospitals and Health Systems. Rigorous criteria were used to identify 375 hospitals that use technology to link up disparate care providers and patients. "Most Wired" hospitals are more likely to share critical information electronically with specialists, to use bar codes for matching medications to patients at the bedside, to use IT to reduce the likelihood of medical errors, to better manage care transitions, and to adopt and meaningfully use certified electronic health records.

Meanwhile, Eric Wicklund, editor of mHealth News, called for nominations of the best wireless hospitals, which are moving toward a wireless landscape for mobile health technology and engaging an ever more connected consumer population.

“I’ve already got a few on my own list,” he writes, asking his readers to submit examples of programs and projects that are doing it right and using mobile health to make a difference.

MHADegree.org, a resource for students and professionals in health administration, named the top 50 most social media-friendly hospitals for 2013, led by Mayo Clinic in Rochester, Minn., and Cleveland Clinic in Cleveland, Ohio.

Hospitals and Health Networks in July presented its 16^th annual list of Most Wired Hospitals and Health Systems. Rigorous criteria were used to identify 375 hospitals that use technology to link up disparate care providers and patients. "Most Wired" hospitals are more likely to share critical information electronically with specialists, to use bar codes for matching medications to patients at the bedside, to use IT to reduce the likelihood of medical errors, to better manage care transitions, and to adopt and meaningfully use certified electronic health records.

Meanwhile, Eric Wicklund, editor of mHealth News, called for nominations of the best wireless hospitals, which are moving toward a wireless landscape for mobile health technology and engaging an ever more connected consumer population.

“I’ve already got a few on my own list,” he writes, asking his readers to submit examples of programs and projects that are doing it right and using mobile health to make a difference.

MHADegree.org, a resource for students and professionals in health administration, named the top 50 most social media-friendly hospitals for 2013, led by Mayo Clinic in Rochester, Minn., and Cleveland Clinic in Cleveland, Ohio.

So it’s your first day on the service. Mrs. Jones has been there for 21 days and has a long list of consultants to address her numerous complications. You see her twice before it’s time to pull it all together and package her up for an 11 a.m. transfer to rehab the next morning. But how do you effectively weed through weeks of documentation to come up with the salient points of the hospital stay, and do so in a reasonable amount of time considering you have 20 other patients (and a few inquisitive family members) who require your undivided attention that day as well?

A preliminary discharge summary, prepared the day before anticipated discharge, can make life a lot easier. If your EMR allows you to sort notes by author or service, you can dictate the hospital course by problem more seamlessly than by reviewing the hospitalization on a day-by-day basis, especially if there are multiple notes from PT/OT, pharmacy, and other ancillary services intermingled in the providers’ documentation.

If your EMR allows you to auto-populate diagnostic test results, discharge medications, and instructions directly into a note, you can create this note on the day of actual discharge, and then copy and paste the dictation of the hospital course into the body of the final discharge summary.

Alternatively, if the provider who is better acquainted with the patient does a discharge summary prior to going off service, the upcoming provider need only add an addendum to this summary on the day of discharge. When partners do these summaries for each other, it can be a tremendous time saver. Instead of spending 45-60 minutes drudging through every progress note and consultation on an unfamiliar patient, you are able to review the preliminary discharge summary and pick up the hospital course as you would for a patient admitted the day before who already has an H&P. The doctor going off service may only need to spend 5-10 minutes dictating the summary.

Of course, different groups have different practice styles. Some groups may consistently dictate summaries prior to going off service, while others may not choose this option. There may be other ways to streamline complicated discharge summaries within groups as well, but experimenting with new and innovative ways to improve care and make our lives more efficient in the process may prove to be a win-win for all.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at healthsavvy@aol.com.

So it’s your first day on the service. Mrs. Jones has been there for 21 days and has a long list of consultants to address her numerous complications. You see her twice before it’s time to pull it all together and package her up for an 11 a.m. transfer to rehab the next morning. But how do you effectively weed through weeks of documentation to come up with the salient points of the hospital stay, and do so in a reasonable amount of time considering you have 20 other patients (and a few inquisitive family members) who require your undivided attention that day as well?

A preliminary discharge summary, prepared the day before anticipated discharge, can make life a lot easier. If your EMR allows you to sort notes by author or service, you can dictate the hospital course by problem more seamlessly than by reviewing the hospitalization on a day-by-day basis, especially if there are multiple notes from PT/OT, pharmacy, and other ancillary services intermingled in the providers’ documentation.

If your EMR allows you to auto-populate diagnostic test results, discharge medications, and instructions directly into a note, you can create this note on the day of actual discharge, and then copy and paste the dictation of the hospital course into the body of the final discharge summary.

Alternatively, if the provider who is better acquainted with the patient does a discharge summary prior to going off service, the upcoming provider need only add an addendum to this summary on the day of discharge. When partners do these summaries for each other, it can be a tremendous time saver. Instead of spending 45-60 minutes drudging through every progress note and consultation on an unfamiliar patient, you are able to review the preliminary discharge summary and pick up the hospital course as you would for a patient admitted the day before who already has an H&P. The doctor going off service may only need to spend 5-10 minutes dictating the summary.

Of course, different groups have different practice styles. Some groups may consistently dictate summaries prior to going off service, while others may not choose this option. There may be other ways to streamline complicated discharge summaries within groups as well, but experimenting with new and innovative ways to improve care and make our lives more efficient in the process may prove to be a win-win for all.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at healthsavvy@aol.com.

So it’s your first day on the service. Mrs. Jones has been there for 21 days and has a long list of consultants to address her numerous complications. You see her twice before it’s time to pull it all together and package her up for an 11 a.m. transfer to rehab the next morning. But how do you effectively weed through weeks of documentation to come up with the salient points of the hospital stay, and do so in a reasonable amount of time considering you have 20 other patients (and a few inquisitive family members) who require your undivided attention that day as well?

A preliminary discharge summary, prepared the day before anticipated discharge, can make life a lot easier. If your EMR allows you to sort notes by author or service, you can dictate the hospital course by problem more seamlessly than by reviewing the hospitalization on a day-by-day basis, especially if there are multiple notes from PT/OT, pharmacy, and other ancillary services intermingled in the providers’ documentation.

If your EMR allows you to auto-populate diagnostic test results, discharge medications, and instructions directly into a note, you can create this note on the day of actual discharge, and then copy and paste the dictation of the hospital course into the body of the final discharge summary.

Alternatively, if the provider who is better acquainted with the patient does a discharge summary prior to going off service, the upcoming provider need only add an addendum to this summary on the day of discharge. When partners do these summaries for each other, it can be a tremendous time saver. Instead of spending 45-60 minutes drudging through every progress note and consultation on an unfamiliar patient, you are able to review the preliminary discharge summary and pick up the hospital course as you would for a patient admitted the day before who already has an H&P. The doctor going off service may only need to spend 5-10 minutes dictating the summary.

Of course, different groups have different practice styles. Some groups may consistently dictate summaries prior to going off service, while others may not choose this option. There may be other ways to streamline complicated discharge summaries within groups as well, but experimenting with new and innovative ways to improve care and make our lives more efficient in the process may prove to be a win-win for all.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at healthsavvy@aol.com.

Steven Z. Pantilat, MD, SFHM, medical director of the University of California San Francisco School of Medicine palliative care service, explains palliative care is not end-of-life care, and the role hospitalists should play in palliative cases.

 

 

Steven Z. Pantilat, MD, SFHM, medical director of the University of California San Francisco School of Medicine palliative care service, explains palliative care is not end-of-life care, and the role hospitalists should play in palliative cases.

 

 

Steven Z. Pantilat, MD, SFHM, medical director of the University of California San Francisco School of Medicine palliative care service, explains palliative care is not end-of-life care, and the role hospitalists should play in palliative cases.

 

 

Josiah Halm, MD, and Sahitya Gadiraju, DO, assistant professors of general internal medicine at M.D. Anderson Cancer Center in Houston, discuss the breadth of care provided to cancer patients, a risk assessment being developed there on readmission risk, and factors in care that go beyond the medical.

Josiah Halm, MD, and Sahitya Gadiraju, DO, assistant professors of general internal medicine at M.D. Anderson Cancer Center in Houston, discuss the breadth of care provided to cancer patients, a risk assessment being developed there on readmission risk, and factors in care that go beyond the medical.

Josiah Halm, MD, and Sahitya Gadiraju, DO, assistant professors of general internal medicine at M.D. Anderson Cancer Center in Houston, discuss the breadth of care provided to cancer patients, a risk assessment being developed there on readmission risk, and factors in care that go beyond the medical.

Tough economic times and the unpredictable consequences of health care reform are making a growing number of solo practitioners and small private groups very nervous. I’ve received many inquiries about protective options, such as joining a multispecialty group, or merging two or more small practices into larger entities.

If becoming an employee of a large corporation does not appeal to you, a merger can offer significant advantages in stabilization of income and expenses; but careful planning, and a written agreement, are essential.

If you are considering this option, here are some things to think about:

What is the compensation formula? Will everyone be paid only for what they do individually, or will revenue be shared equally? I favor a combination; productivity is rewarded, but your income doesn’t drop to zero when you take time off.

Who will be in charge, and what percentage vote will be needed to approve important decisions? Typically, the majority rules, but you may wish to create a list of pivotal moves that will require unanimous approval, such as purchasing expensive equipment, borrowing money, or adding new partners.

Will you keep your retirement plans separate, or combine them? If the latter, you will have to agree on the terms of the new plan, which can be the same or different from any of the existing plans. You’ll probably need some legal guidance to ensure that assets from existing plans can be transferred into a new plan without tax issues.

Since most private practices are incorporated, there are two basic options for combining them: Corporation A can simply absorb corporation B; the latter ceases to exist, and corporation A, the so-called “surviving entity,” assumes all assets and liabilities of both old corporations. Corporation B shareholders exchange shares of its stock for shares of corporation A, with adjustments for any inequalities in stock value.

The second option is to start a completely new corporation. Both separate entities dissolve and distribute their equipment and charts to their shareholders, who then transfer the assets to the new corporation.

Option 2 is popular, but I am not a fan. It is billed as an opportunity to start fresh, shielding everyone from exposure to malpractice suits and other liabilities. However, the reality is that anyone looking to sue either old corporation will simply sue the new entity as the so-called “successor” corporation, on the grounds that it has assumed responsibility for its predecessors’ liabilities. You also will need new provider numbers, which may impede cash flow for months. Plus, the IRS treats corporate liquidations, even for merger purposes, as sales of assets, and taxes them.

In general, most experts that I’ve talked with favor outright merger of the corporations. This option is tax neutral, and while it may theoretically be less satisfactory liability-wise, you can minimize risk by examining financial and legal records, and by identifying any glaring flaws in charting or coding. Your lawyers can add “hold harmless” clauses to the merger agreement, indemnifying each party against the others’ liabilities. This area in particular is where you need experienced, competent legal advice.

Another common sticking point is known as “equalization.” Ideally, each party brings an equal amount of assets to the table, but in the real world that is rarely the case. One party may contribute more equipment, for example, and the others are often asked to make up the difference (“equalize”) with something else, usually cash.

An alternative is to agree that any inequalities will be compensated at the other end, in the form of buyout value; that is, physicians contributing more assets will receive larger buyouts when they leave or retire than those contributing less.

Non-compete provisions are always a difficult issue, mostly because they are so hard (and expensive) to enforce. An increasingly popular alternative is, once again, to deal with it at the other end, with a buyout penalty. An unhappy partner can leave, and compete, but at the cost of a substantially reduced buyout. This permits competition, but discourages it; and it compensates the remaining partners.

These are only some of the pivotal business and legal issues that must be settled in advance. A little planning and negotiation can prevent a lot of grief, regret, and legal expenses in the future. I’ll mention some other, more complicated merger options in a future column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Skin & Allergy News. Additional columns are available online at edermatologynews.com.

Tough economic times and the unpredictable consequences of health care reform are making a growing number of solo practitioners and small private groups very nervous. I’ve received many inquiries about protective options, such as joining a multispecialty group, or merging two or more small practices into larger entities.

If becoming an employee of a large corporation does not appeal to you, a merger can offer significant advantages in stabilization of income and expenses; but careful planning, and a written agreement, are essential.

If you are considering this option, here are some things to think about:

What is the compensation formula? Will everyone be paid only for what they do individually, or will revenue be shared equally? I favor a combination; productivity is rewarded, but your income doesn’t drop to zero when you take time off.

Who will be in charge, and what percentage vote will be needed to approve important decisions? Typically, the majority rules, but you may wish to create a list of pivotal moves that will require unanimous approval, such as purchasing expensive equipment, borrowing money, or adding new partners.

Will you keep your retirement plans separate, or combine them? If the latter, you will have to agree on the terms of the new plan, which can be the same or different from any of the existing plans. You’ll probably need some legal guidance to ensure that assets from existing plans can be transferred into a new plan without tax issues.

Since most private practices are incorporated, there are two basic options for combining them: Corporation A can simply absorb corporation B; the latter ceases to exist, and corporation A, the so-called “surviving entity,” assumes all assets and liabilities of both old corporations. Corporation B shareholders exchange shares of its stock for shares of corporation A, with adjustments for any inequalities in stock value.

The second option is to start a completely new corporation. Both separate entities dissolve and distribute their equipment and charts to their shareholders, who then transfer the assets to the new corporation.

Option 2 is popular, but I am not a fan. It is billed as an opportunity to start fresh, shielding everyone from exposure to malpractice suits and other liabilities. However, the reality is that anyone looking to sue either old corporation will simply sue the new entity as the so-called “successor” corporation, on the grounds that it has assumed responsibility for its predecessors’ liabilities. You also will need new provider numbers, which may impede cash flow for months. Plus, the IRS treats corporate liquidations, even for merger purposes, as sales of assets, and taxes them.

In general, most experts that I’ve talked with favor outright merger of the corporations. This option is tax neutral, and while it may theoretically be less satisfactory liability-wise, you can minimize risk by examining financial and legal records, and by identifying any glaring flaws in charting or coding. Your lawyers can add “hold harmless” clauses to the merger agreement, indemnifying each party against the others’ liabilities. This area in particular is where you need experienced, competent legal advice.

Another common sticking point is known as “equalization.” Ideally, each party brings an equal amount of assets to the table, but in the real world that is rarely the case. One party may contribute more equipment, for example, and the others are often asked to make up the difference (“equalize”) with something else, usually cash.

An alternative is to agree that any inequalities will be compensated at the other end, in the form of buyout value; that is, physicians contributing more assets will receive larger buyouts when they leave or retire than those contributing less.

Non-compete provisions are always a difficult issue, mostly because they are so hard (and expensive) to enforce. An increasingly popular alternative is, once again, to deal with it at the other end, with a buyout penalty. An unhappy partner can leave, and compete, but at the cost of a substantially reduced buyout. This permits competition, but discourages it; and it compensates the remaining partners.

These are only some of the pivotal business and legal issues that must be settled in advance. A little planning and negotiation can prevent a lot of grief, regret, and legal expenses in the future. I’ll mention some other, more complicated merger options in a future column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Skin & Allergy News. Additional columns are available online at edermatologynews.com.

Tough economic times and the unpredictable consequences of health care reform are making a growing number of solo practitioners and small private groups very nervous. I’ve received many inquiries about protective options, such as joining a multispecialty group, or merging two or more small practices into larger entities.

If becoming an employee of a large corporation does not appeal to you, a merger can offer significant advantages in stabilization of income and expenses; but careful planning, and a written agreement, are essential.

If you are considering this option, here are some things to think about:

What is the compensation formula? Will everyone be paid only for what they do individually, or will revenue be shared equally? I favor a combination; productivity is rewarded, but your income doesn’t drop to zero when you take time off.

Who will be in charge, and what percentage vote will be needed to approve important decisions? Typically, the majority rules, but you may wish to create a list of pivotal moves that will require unanimous approval, such as purchasing expensive equipment, borrowing money, or adding new partners.

Will you keep your retirement plans separate, or combine them? If the latter, you will have to agree on the terms of the new plan, which can be the same or different from any of the existing plans. You’ll probably need some legal guidance to ensure that assets from existing plans can be transferred into a new plan without tax issues.

Since most private practices are incorporated, there are two basic options for combining them: Corporation A can simply absorb corporation B; the latter ceases to exist, and corporation A, the so-called “surviving entity,” assumes all assets and liabilities of both old corporations. Corporation B shareholders exchange shares of its stock for shares of corporation A, with adjustments for any inequalities in stock value.

The second option is to start a completely new corporation. Both separate entities dissolve and distribute their equipment and charts to their shareholders, who then transfer the assets to the new corporation.

Option 2 is popular, but I am not a fan. It is billed as an opportunity to start fresh, shielding everyone from exposure to malpractice suits and other liabilities. However, the reality is that anyone looking to sue either old corporation will simply sue the new entity as the so-called “successor” corporation, on the grounds that it has assumed responsibility for its predecessors’ liabilities. You also will need new provider numbers, which may impede cash flow for months. Plus, the IRS treats corporate liquidations, even for merger purposes, as sales of assets, and taxes them.

In general, most experts that I’ve talked with favor outright merger of the corporations. This option is tax neutral, and while it may theoretically be less satisfactory liability-wise, you can minimize risk by examining financial and legal records, and by identifying any glaring flaws in charting or coding. Your lawyers can add “hold harmless” clauses to the merger agreement, indemnifying each party against the others’ liabilities. This area in particular is where you need experienced, competent legal advice.

Another common sticking point is known as “equalization.” Ideally, each party brings an equal amount of assets to the table, but in the real world that is rarely the case. One party may contribute more equipment, for example, and the others are often asked to make up the difference (“equalize”) with something else, usually cash.

An alternative is to agree that any inequalities will be compensated at the other end, in the form of buyout value; that is, physicians contributing more assets will receive larger buyouts when they leave or retire than those contributing less.

Non-compete provisions are always a difficult issue, mostly because they are so hard (and expensive) to enforce. An increasingly popular alternative is, once again, to deal with it at the other end, with a buyout penalty. An unhappy partner can leave, and compete, but at the cost of a substantially reduced buyout. This permits competition, but discourages it; and it compensates the remaining partners.

These are only some of the pivotal business and legal issues that must be settled in advance. A little planning and negotiation can prevent a lot of grief, regret, and legal expenses in the future. I’ll mention some other, more complicated merger options in a future column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Skin & Allergy News. Additional columns are available online at edermatologynews.com.

A new study suggests that half of all people recently diagnosed with cancer in England and Wales should survive their disease for at least 10 years, whereas, 40 years ago, only about a quarter of cancer patients could expect the same.

The research, published in The Lancet, showed significant improvements in long-term cancer survival rates from 1971 to 2011, particularly among patients with hematologic malignancies.

Unfortunately, the outlook for some malignancies remained extremely poor over the period studied.

“Although survival for some cancers has improved dramatically over the past 40 years, others are lagging far behind,” said Manuela Quaresma, of the London School of Hygiene & Tropical Medicine in the UK.

“More investment is urgently needed to improve early diagnosis and provide the best treatment, including more specialist surgeons for poor-prognosis cancers like lung cancer, which have shown little or no evidence of improvement in long-term survival (5 and 10 years after diagnosis) over the past 40 years.”

Quaresma and her colleagues analyzed survival trends for more than 7 million adults (aged 15 to 99 years) diagnosed with one of 21 common cancers in England and Wales between 1971 and 2011, and followed up to the end of 2012.

The researchers observed an increase in 10-year survival for all cancers combined. Twenty-four percent of patients diagnosed in 1971-1972 survived at least 10 years. And 49.8% of patients diagnosed in 2010-2011 are expected to survive at least 10 years.

The data revealed substantial improvements for patients with hematologic malignancies as well. For Hodgkin lymphoma, the 10-year survival rate rose from 47.7% for patients diagnosed in 1971-1972 to 80% for those diagnosed in 2010-2011.

For non-Hodgkin lymphoma, the 10-year survival rate increased from 22% to 63.1%. For multiple myeloma, it rose from 6.2% to 32.6%. And for leukemia, it rose from 6.9% to 46.1%.

The researchers noted that the most recent 10-year survival estimates are above 70% for cancers of the breast, prostate, testis, and uterus, as well as for melanoma and Hodgkin lymphoma. Furthermore, improvements in survival are greatest for these cancers.

Unfortunately, several other malignancies continue to have poor long-term survival. For cancers of the brain, stomach, lung, esophagus, and pancreas, 10-year survival after diagnosis is still below 15% for patients diagnosed in 2010-2011.

“These 5 cancers impose a huge public health burden, both because they are common and because they are often diagnosed at a late stage, when they are much harder to treat,” said study author Bernard Rachet, MD, PhD, of the London School of Hygiene & Tropical Medicine.

Dr Rachet also noted that this research confirms a persistent “age gap” in survival between younger and older patients for all cancers.

“Even after we have adjusted for the fact that older people have much higher death rates from other diseases than younger people, elderly cancer patients are doing worse for all cancers,” he said.

“This problem is particularly marked in the UK. In other countries, the age gap in cancer survival has become much narrower over the last 15 to 20 years than in England and Wales.”

A new study suggests that half of all people recently diagnosed with cancer in England and Wales should survive their disease for at least 10 years, whereas, 40 years ago, only about a quarter of cancer patients could expect the same.

The research, published in The Lancet, showed significant improvements in long-term cancer survival rates from 1971 to 2011, particularly among patients with hematologic malignancies.

Unfortunately, the outlook for some malignancies remained extremely poor over the period studied.

“Although survival for some cancers has improved dramatically over the past 40 years, others are lagging far behind,” said Manuela Quaresma, of the London School of Hygiene & Tropical Medicine in the UK.

“More investment is urgently needed to improve early diagnosis and provide the best treatment, including more specialist surgeons for poor-prognosis cancers like lung cancer, which have shown little or no evidence of improvement in long-term survival (5 and 10 years after diagnosis) over the past 40 years.”

Quaresma and her colleagues analyzed survival trends for more than 7 million adults (aged 15 to 99 years) diagnosed with one of 21 common cancers in England and Wales between 1971 and 2011, and followed up to the end of 2012.

The researchers observed an increase in 10-year survival for all cancers combined. Twenty-four percent of patients diagnosed in 1971-1972 survived at least 10 years. And 49.8% of patients diagnosed in 2010-2011 are expected to survive at least 10 years.

The data revealed substantial improvements for patients with hematologic malignancies as well. For Hodgkin lymphoma, the 10-year survival rate rose from 47.7% for patients diagnosed in 1971-1972 to 80% for those diagnosed in 2010-2011.

For non-Hodgkin lymphoma, the 10-year survival rate increased from 22% to 63.1%. For multiple myeloma, it rose from 6.2% to 32.6%. And for leukemia, it rose from 6.9% to 46.1%.

The researchers noted that the most recent 10-year survival estimates are above 70% for cancers of the breast, prostate, testis, and uterus, as well as for melanoma and Hodgkin lymphoma. Furthermore, improvements in survival are greatest for these cancers.

Unfortunately, several other malignancies continue to have poor long-term survival. For cancers of the brain, stomach, lung, esophagus, and pancreas, 10-year survival after diagnosis is still below 15% for patients diagnosed in 2010-2011.

“These 5 cancers impose a huge public health burden, both because they are common and because they are often diagnosed at a late stage, when they are much harder to treat,” said study author Bernard Rachet, MD, PhD, of the London School of Hygiene & Tropical Medicine.

Dr Rachet also noted that this research confirms a persistent “age gap” in survival between younger and older patients for all cancers.

“Even after we have adjusted for the fact that older people have much higher death rates from other diseases than younger people, elderly cancer patients are doing worse for all cancers,” he said.

“This problem is particularly marked in the UK. In other countries, the age gap in cancer survival has become much narrower over the last 15 to 20 years than in England and Wales.”

A new study suggests that half of all people recently diagnosed with cancer in England and Wales should survive their disease for at least 10 years, whereas, 40 years ago, only about a quarter of cancer patients could expect the same.

The research, published in The Lancet, showed significant improvements in long-term cancer survival rates from 1971 to 2011, particularly among patients with hematologic malignancies.

Unfortunately, the outlook for some malignancies remained extremely poor over the period studied.

“Although survival for some cancers has improved dramatically over the past 40 years, others are lagging far behind,” said Manuela Quaresma, of the London School of Hygiene & Tropical Medicine in the UK.

“More investment is urgently needed to improve early diagnosis and provide the best treatment, including more specialist surgeons for poor-prognosis cancers like lung cancer, which have shown little or no evidence of improvement in long-term survival (5 and 10 years after diagnosis) over the past 40 years.”

Quaresma and her colleagues analyzed survival trends for more than 7 million adults (aged 15 to 99 years) diagnosed with one of 21 common cancers in England and Wales between 1971 and 2011, and followed up to the end of 2012.

The researchers observed an increase in 10-year survival for all cancers combined. Twenty-four percent of patients diagnosed in 1971-1972 survived at least 10 years. And 49.8% of patients diagnosed in 2010-2011 are expected to survive at least 10 years.

The data revealed substantial improvements for patients with hematologic malignancies as well. For Hodgkin lymphoma, the 10-year survival rate rose from 47.7% for patients diagnosed in 1971-1972 to 80% for those diagnosed in 2010-2011.

For non-Hodgkin lymphoma, the 10-year survival rate increased from 22% to 63.1%. For multiple myeloma, it rose from 6.2% to 32.6%. And for leukemia, it rose from 6.9% to 46.1%.

The researchers noted that the most recent 10-year survival estimates are above 70% for cancers of the breast, prostate, testis, and uterus, as well as for melanoma and Hodgkin lymphoma. Furthermore, improvements in survival are greatest for these cancers.

Unfortunately, several other malignancies continue to have poor long-term survival. For cancers of the brain, stomach, lung, esophagus, and pancreas, 10-year survival after diagnosis is still below 15% for patients diagnosed in 2010-2011.

“These 5 cancers impose a huge public health burden, both because they are common and because they are often diagnosed at a late stage, when they are much harder to treat,” said study author Bernard Rachet, MD, PhD, of the London School of Hygiene & Tropical Medicine.

Dr Rachet also noted that this research confirms a persistent “age gap” in survival between younger and older patients for all cancers.

“Even after we have adjusted for the fact that older people have much higher death rates from other diseases than younger people, elderly cancer patients are doing worse for all cancers,” he said.

“This problem is particularly marked in the UK. In other countries, the age gap in cancer survival has become much narrower over the last 15 to 20 years than in England and Wales.”

 

The European Medicines Agency (EMA) has granted orphan drug designation for selinexor (KPT-330) to treat multiple myeloma (MM) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), including Richter’s transformation.

 

Selinexor previously received orphan designation from both the EMA and the US Food and Drug Administration to treat patients with acute myeloid leukemia and those with diffuse large B-cell lymphoma.

 

Orphan designation is granted to promote the development of drugs that target rare, life-threatening or debilitating conditions and are expected to provide a significant therapeutic advantage over existing treatments.

 

Orphan designation qualifies a company—in this case, Karyopharm Therapeutics Inc.—for benefits that include targeted scientific advice from the EMA regarding drug development and 10 years of market exclusivity following the drug’s approval.

 

About selinexor

 

Selinexor (KPT-330) is a first-in-class, oral selective inhibitor of nuclear export (SINE) compound. Selinexor functions by inhibiting the nuclear export protein XPO1 (also called CRM1).

 

This leads to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function. This is thought to prompt apoptosis in cancer cells while largely sparing normal cells.

 

Selinexor has shown promise in an ongoing phase 1 study of patients with a range of hematologic malignancies. Results of this trial were presented at the 2014 ASCO Annual Meeting.

 

At that point, the study included 51 patients who had received selinexor across 8 dose levels, ranging from 3 mg/m² to 60 mg/m².

 

Among the 43 patients evaluable for response, the overall response rate was 28%, and the complete response rate was 5%.

 

Most adverse events were gastrointestinal in nature, and most of them were grade 1 or 2. The most common adverse events were nausea, anorexia, and fatigue.

 

There were 3 dose-limiting toxicities, including 1 MM patient with grade 4 thrombocytopenia, 1 follicular lymphoma patient with grade 4 thrombocytopenia, and 1 CLL patient with grade 2 fatigue.

 

The European Medicines Agency (EMA) has granted orphan drug designation for selinexor (KPT-330) to treat multiple myeloma (MM) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), including Richter’s transformation.

 

Selinexor previously received orphan designation from both the EMA and the US Food and Drug Administration to treat patients with acute myeloid leukemia and those with diffuse large B-cell lymphoma.

 

Orphan designation is granted to promote the development of drugs that target rare, life-threatening or debilitating conditions and are expected to provide a significant therapeutic advantage over existing treatments.

 

Orphan designation qualifies a company—in this case, Karyopharm Therapeutics Inc.—for benefits that include targeted scientific advice from the EMA regarding drug development and 10 years of market exclusivity following the drug’s approval.

 

About selinexor

 

Selinexor (KPT-330) is a first-in-class, oral selective inhibitor of nuclear export (SINE) compound. Selinexor functions by inhibiting the nuclear export protein XPO1 (also called CRM1).

 

This leads to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function. This is thought to prompt apoptosis in cancer cells while largely sparing normal cells.

 

Selinexor has shown promise in an ongoing phase 1 study of patients with a range of hematologic malignancies. Results of this trial were presented at the 2014 ASCO Annual Meeting.

 

At that point, the study included 51 patients who had received selinexor across 8 dose levels, ranging from 3 mg/m² to 60 mg/m².

 

Among the 43 patients evaluable for response, the overall response rate was 28%, and the complete response rate was 5%.

 

Most adverse events were gastrointestinal in nature, and most of them were grade 1 or 2. The most common adverse events were nausea, anorexia, and fatigue.

 

There were 3 dose-limiting toxicities, including 1 MM patient with grade 4 thrombocytopenia, 1 follicular lymphoma patient with grade 4 thrombocytopenia, and 1 CLL patient with grade 2 fatigue.

 

The European Medicines Agency (EMA) has granted orphan drug designation for selinexor (KPT-330) to treat multiple myeloma (MM) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), including Richter’s transformation.

 

Selinexor previously received orphan designation from both the EMA and the US Food and Drug Administration to treat patients with acute myeloid leukemia and those with diffuse large B-cell lymphoma.

 

Orphan designation is granted to promote the development of drugs that target rare, life-threatening or debilitating conditions and are expected to provide a significant therapeutic advantage over existing treatments.

 

Orphan designation qualifies a company—in this case, Karyopharm Therapeutics Inc.—for benefits that include targeted scientific advice from the EMA regarding drug development and 10 years of market exclusivity following the drug’s approval.

 

About selinexor

 

Selinexor (KPT-330) is a first-in-class, oral selective inhibitor of nuclear export (SINE) compound. Selinexor functions by inhibiting the nuclear export protein XPO1 (also called CRM1).

 

This leads to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function. This is thought to prompt apoptosis in cancer cells while largely sparing normal cells.

 

Selinexor has shown promise in an ongoing phase 1 study of patients with a range of hematologic malignancies. Results of this trial were presented at the 2014 ASCO Annual Meeting.

 

At that point, the study included 51 patients who had received selinexor across 8 dose levels, ranging from 3 mg/m² to 60 mg/m².

 

Among the 43 patients evaluable for response, the overall response rate was 28%, and the complete response rate was 5%.

 

Most adverse events were gastrointestinal in nature, and most of them were grade 1 or 2. The most common adverse events were nausea, anorexia, and fatigue.

 

There were 3 dose-limiting toxicities, including 1 MM patient with grade 4 thrombocytopenia, 1 follicular lymphoma patient with grade 4 thrombocytopenia, and 1 CLL patient with grade 2 fatigue.

The UK’s National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending eculizumab (Soliris) for funding to treat atypical hemolytic uremic syndrome (aHUS).

However, the agency has a few requirements. Eculizumab use must be coordinated through an expert center.

And monitoring systems must record the number of people with aHUS, the number who receive eculizumab, and the dose and duration of treatment.

NICE is also requiring a national protocol for starting and stopping eculizumab for clinical reasons and a research program with robust methods to evaluate when stopping treatment or dose adjustment might occur.

“[A NICE advisory] committee accepted that eculizumab is a step change in the management of aHUS and can be considered a significant innovation for a disease with a high unmet clinical need,” said NICE Chief Executive Sir Andrew Dillon.

“Eculizumab offers people with aHUS the possibility of avoiding end-stage renal failure, dialysis, and kidney transplantation, as well as other organ damage. The drug is, however, very expensive. The committee felt that the budget impact of eculizumab would be lower if the potential for dose adjustment and stopping treatment was explored.”

“This is reflected in the draft guidance, which recommends eculizumab should be funded only if important conditions are met, including the development of rules for starting and stopping treatment for clinical reasons. In the meantime, NHS England and the company [developing the drug, Alexion Pharmaceuticals] should consider what opportunities might exist to reduce the cost of eculizumab to the NHS.”

Eculizumab: Dosing, cost, and benefit

Eculizumab is given intravenously in adults as initial treatment at a dose of 900 mg for 4 weeks, then as maintenance treatment at a dose of 1200 mg on week 5, and then every 12 to 16 days. The summary of product characteristics for eculizumab states that “treatment is recommended to continue for a patient’s lifetime, unless discontinuation of treatment is clinically indicated.”

Eculizumab costs £3150 per 30 ml vial (excluding value-added tax). The net budget impact of eculizumab based on the company’s predicted rate of uptake over a 5-year period is confidential.

However, to allow consultees and commentators to properly engage in the consultation process, NICE has prepared an illustration of the possible budget impact of eculizumab for aHUS, using information available in the public domain.

NICE’s estimate is based on a treatment cost of £340,200 per adult patient in the first year (based on the acquisition cost of the drug and the recommended dosing for an adult), and assumes a patient cohort of 170, as estimated by NHS England in its interim commissioning policy.

If it is assumed that all of these adult patients with aHUS are treated with eculizumab, the budget impact for the first year would be £57.8 million.

If an additional 20 new patients are treated the following year (based on a worldwide incidence of 0.4 per million), the budget impact will rise to £62.5 million in year 2, assuming all new patients are treated and all existing patients continue to be treated at the maintenance cost of £327,600 per year.

Using the same assumptions, the budget impact will rise to £69 million in year 3 (190 existing and 20 new patients), £75 million in year 4 (210 existing and 20 new patients), and £82 million in year 5 (230 existing and 20 new patients).

NHS England has indicated that the amount of the budget allocated for highly specialized services in 2013/2014 was £544 million, and the spending on high-cost drugs was £156 million.

 

The advisory committee acknowledged that the company’s estimate of the incremental cost of eculizumab compared with standard care was considerable and that incremental costs estimated by the evidence review group were higher still (results are confidential).

The company estimated that eculizumab produced 25.22 additional quality-adjusted life-years (QALYs) per patient compared with standard care. Although the QALYs estimated in the evidence review group’s analysis were markedly lower than those calculated by the company, both analyses produced substantial QALY gains of a magnitude that is rarely seen for any new drug treatment.

NICE has not yet issued final guidance on eculizumab in aHUS. The draft guidance is now with consultees, including the company, healthcare professionals, and patient/carer organizations, who have the opportunity to appeal against the draft recommendations.

Final guidance on the use of eculizumab to treat aHUS is expected in January 2015.

The UK’s National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending eculizumab (Soliris) for funding to treat atypical hemolytic uremic syndrome (aHUS).

However, the agency has a few requirements. Eculizumab use must be coordinated through an expert center.

And monitoring systems must record the number of people with aHUS, the number who receive eculizumab, and the dose and duration of treatment.

NICE is also requiring a national protocol for starting and stopping eculizumab for clinical reasons and a research program with robust methods to evaluate when stopping treatment or dose adjustment might occur.

“[A NICE advisory] committee accepted that eculizumab is a step change in the management of aHUS and can be considered a significant innovation for a disease with a high unmet clinical need,” said NICE Chief Executive Sir Andrew Dillon.

“Eculizumab offers people with aHUS the possibility of avoiding end-stage renal failure, dialysis, and kidney transplantation, as well as other organ damage. The drug is, however, very expensive. The committee felt that the budget impact of eculizumab would be lower if the potential for dose adjustment and stopping treatment was explored.”

“This is reflected in the draft guidance, which recommends eculizumab should be funded only if important conditions are met, including the development of rules for starting and stopping treatment for clinical reasons. In the meantime, NHS England and the company [developing the drug, Alexion Pharmaceuticals] should consider what opportunities might exist to reduce the cost of eculizumab to the NHS.”

Eculizumab: Dosing, cost, and benefit

Eculizumab is given intravenously in adults as initial treatment at a dose of 900 mg for 4 weeks, then as maintenance treatment at a dose of 1200 mg on week 5, and then every 12 to 16 days. The summary of product characteristics for eculizumab states that “treatment is recommended to continue for a patient’s lifetime, unless discontinuation of treatment is clinically indicated.”

Eculizumab costs £3150 per 30 ml vial (excluding value-added tax). The net budget impact of eculizumab based on the company’s predicted rate of uptake over a 5-year period is confidential.

However, to allow consultees and commentators to properly engage in the consultation process, NICE has prepared an illustration of the possible budget impact of eculizumab for aHUS, using information available in the public domain.

NICE’s estimate is based on a treatment cost of £340,200 per adult patient in the first year (based on the acquisition cost of the drug and the recommended dosing for an adult), and assumes a patient cohort of 170, as estimated by NHS England in its interim commissioning policy.

If it is assumed that all of these adult patients with aHUS are treated with eculizumab, the budget impact for the first year would be £57.8 million.

If an additional 20 new patients are treated the following year (based on a worldwide incidence of 0.4 per million), the budget impact will rise to £62.5 million in year 2, assuming all new patients are treated and all existing patients continue to be treated at the maintenance cost of £327,600 per year.

Using the same assumptions, the budget impact will rise to £69 million in year 3 (190 existing and 20 new patients), £75 million in year 4 (210 existing and 20 new patients), and £82 million in year 5 (230 existing and 20 new patients).

NHS England has indicated that the amount of the budget allocated for highly specialized services in 2013/2014 was £544 million, and the spending on high-cost drugs was £156 million.

 

The advisory committee acknowledged that the company’s estimate of the incremental cost of eculizumab compared with standard care was considerable and that incremental costs estimated by the evidence review group were higher still (results are confidential).

The company estimated that eculizumab produced 25.22 additional quality-adjusted life-years (QALYs) per patient compared with standard care. Although the QALYs estimated in the evidence review group’s analysis were markedly lower than those calculated by the company, both analyses produced substantial QALY gains of a magnitude that is rarely seen for any new drug treatment.

NICE has not yet issued final guidance on eculizumab in aHUS. The draft guidance is now with consultees, including the company, healthcare professionals, and patient/carer organizations, who have the opportunity to appeal against the draft recommendations.

Final guidance on the use of eculizumab to treat aHUS is expected in January 2015.

The UK’s National Institute for Health and Care Excellence (NICE) has issued a final draft guidance recommending eculizumab (Soliris) for funding to treat atypical hemolytic uremic syndrome (aHUS).

However, the agency has a few requirements. Eculizumab use must be coordinated through an expert center.

And monitoring systems must record the number of people with aHUS, the number who receive eculizumab, and the dose and duration of treatment.

NICE is also requiring a national protocol for starting and stopping eculizumab for clinical reasons and a research program with robust methods to evaluate when stopping treatment or dose adjustment might occur.

“[A NICE advisory] committee accepted that eculizumab is a step change in the management of aHUS and can be considered a significant innovation for a disease with a high unmet clinical need,” said NICE Chief Executive Sir Andrew Dillon.

“Eculizumab offers people with aHUS the possibility of avoiding end-stage renal failure, dialysis, and kidney transplantation, as well as other organ damage. The drug is, however, very expensive. The committee felt that the budget impact of eculizumab would be lower if the potential for dose adjustment and stopping treatment was explored.”

“This is reflected in the draft guidance, which recommends eculizumab should be funded only if important conditions are met, including the development of rules for starting and stopping treatment for clinical reasons. In the meantime, NHS England and the company [developing the drug, Alexion Pharmaceuticals] should consider what opportunities might exist to reduce the cost of eculizumab to the NHS.”

Eculizumab: Dosing, cost, and benefit

Eculizumab is given intravenously in adults as initial treatment at a dose of 900 mg for 4 weeks, then as maintenance treatment at a dose of 1200 mg on week 5, and then every 12 to 16 days. The summary of product characteristics for eculizumab states that “treatment is recommended to continue for a patient’s lifetime, unless discontinuation of treatment is clinically indicated.”

Eculizumab costs £3150 per 30 ml vial (excluding value-added tax). The net budget impact of eculizumab based on the company’s predicted rate of uptake over a 5-year period is confidential.

However, to allow consultees and commentators to properly engage in the consultation process, NICE has prepared an illustration of the possible budget impact of eculizumab for aHUS, using information available in the public domain.

NICE’s estimate is based on a treatment cost of £340,200 per adult patient in the first year (based on the acquisition cost of the drug and the recommended dosing for an adult), and assumes a patient cohort of 170, as estimated by NHS England in its interim commissioning policy.

If it is assumed that all of these adult patients with aHUS are treated with eculizumab, the budget impact for the first year would be £57.8 million.

If an additional 20 new patients are treated the following year (based on a worldwide incidence of 0.4 per million), the budget impact will rise to £62.5 million in year 2, assuming all new patients are treated and all existing patients continue to be treated at the maintenance cost of £327,600 per year.

Using the same assumptions, the budget impact will rise to £69 million in year 3 (190 existing and 20 new patients), £75 million in year 4 (210 existing and 20 new patients), and £82 million in year 5 (230 existing and 20 new patients).

NHS England has indicated that the amount of the budget allocated for highly specialized services in 2013/2014 was £544 million, and the spending on high-cost drugs was £156 million.

 

The advisory committee acknowledged that the company’s estimate of the incremental cost of eculizumab compared with standard care was considerable and that incremental costs estimated by the evidence review group were higher still (results are confidential).

The company estimated that eculizumab produced 25.22 additional quality-adjusted life-years (QALYs) per patient compared with standard care. Although the QALYs estimated in the evidence review group’s analysis were markedly lower than those calculated by the company, both analyses produced substantial QALY gains of a magnitude that is rarely seen for any new drug treatment.

NICE has not yet issued final guidance on eculizumab in aHUS. The draft guidance is now with consultees, including the company, healthcare professionals, and patient/carer organizations, who have the opportunity to appeal against the draft recommendations.

Final guidance on the use of eculizumab to treat aHUS is expected in January 2015.