A majority of pertussis cases in the United States may go undetected in people under the age of 50, particularly in adults, results of a retrospective database cohort study suggest.

“The incidence of pertussis in adolescents and adults is very difficult to quantify,” wrote Chi-Chang Chen, MD, of IMS Health, Plymouth Meeting, Pa., and associates. Symptoms may be misdiagnosed as other respiratory illnesses, infected individuals may not seek treatment, and pertussis may not be considered as a possible diagnosis in adults, they noted.

©Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

To project the possible range of pertussis incidence in this population, the investigator used three different models to analyze information from private insurance and laboratory databases as well as data from the Centers for Disease Control and Prevention for a 6-year period. The first method, which used medical claims for ICD-9 diagnosed pertussis, found an annual incidence rate of 9/100,000 population. The second used a proxy pertussis model that was based on symptoms that could indicate undiagnosed pertussis, showing an incidence rate of 21/100,000. The third method used pathogen data to estimate the fraction of cough illness statistically attributable to pertussis, resulting in an incidence rate of 649/100,000 population, which is 58-93 times higher than the ICD-9 estimated incidence.

These estimates “highlight the need for improved preventive measures – such as increased vaccination – against pertussis,” the investigators said, noting that immunization recommendations for additional age groups and research involving strategies to reduce waning immunity after vaccination should be considered.

The study was funded by GlaxoSmithKline Vaccines.

Read the full study in Human Vaccines & Immunotherapeutics (2016 May. doi: 10.1080/21645515.2016.1186313).

[email protected]

A majority of pertussis cases in the United States may go undetected in people under the age of 50, particularly in adults, results of a retrospective database cohort study suggest.

“The incidence of pertussis in adolescents and adults is very difficult to quantify,” wrote Chi-Chang Chen, MD, of IMS Health, Plymouth Meeting, Pa., and associates. Symptoms may be misdiagnosed as other respiratory illnesses, infected individuals may not seek treatment, and pertussis may not be considered as a possible diagnosis in adults, they noted.

©Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

To project the possible range of pertussis incidence in this population, the investigator used three different models to analyze information from private insurance and laboratory databases as well as data from the Centers for Disease Control and Prevention for a 6-year period. The first method, which used medical claims for ICD-9 diagnosed pertussis, found an annual incidence rate of 9/100,000 population. The second used a proxy pertussis model that was based on symptoms that could indicate undiagnosed pertussis, showing an incidence rate of 21/100,000. The third method used pathogen data to estimate the fraction of cough illness statistically attributable to pertussis, resulting in an incidence rate of 649/100,000 population, which is 58-93 times higher than the ICD-9 estimated incidence.

These estimates “highlight the need for improved preventive measures – such as increased vaccination – against pertussis,” the investigators said, noting that immunization recommendations for additional age groups and research involving strategies to reduce waning immunity after vaccination should be considered.

The study was funded by GlaxoSmithKline Vaccines.

Read the full study in Human Vaccines & Immunotherapeutics (2016 May. doi: 10.1080/21645515.2016.1186313).

[email protected]

A majority of pertussis cases in the United States may go undetected in people under the age of 50, particularly in adults, results of a retrospective database cohort study suggest.

“The incidence of pertussis in adolescents and adults is very difficult to quantify,” wrote Chi-Chang Chen, MD, of IMS Health, Plymouth Meeting, Pa., and associates. Symptoms may be misdiagnosed as other respiratory illnesses, infected individuals may not seek treatment, and pertussis may not be considered as a possible diagnosis in adults, they noted.

©Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

To project the possible range of pertussis incidence in this population, the investigator used three different models to analyze information from private insurance and laboratory databases as well as data from the Centers for Disease Control and Prevention for a 6-year period. The first method, which used medical claims for ICD-9 diagnosed pertussis, found an annual incidence rate of 9/100,000 population. The second used a proxy pertussis model that was based on symptoms that could indicate undiagnosed pertussis, showing an incidence rate of 21/100,000. The third method used pathogen data to estimate the fraction of cough illness statistically attributable to pertussis, resulting in an incidence rate of 649/100,000 population, which is 58-93 times higher than the ICD-9 estimated incidence.

These estimates “highlight the need for improved preventive measures – such as increased vaccination – against pertussis,” the investigators said, noting that immunization recommendations for additional age groups and research involving strategies to reduce waning immunity after vaccination should be considered.

The study was funded by GlaxoSmithKline Vaccines.

Read the full study in Human Vaccines & Immunotherapeutics (2016 May. doi: 10.1080/21645515.2016.1186313).

[email protected]

Something new is being tried to improve gout outcomes in the United States: Pharmacists are being recruited to help manage patients.

People with too-high serum urate levels who agree to extra help are being referred to pharmacists empowered to order blood tests and allopurinol. Pharmacists contact patients by mail or phone, at first, and then maybe automated messages or emails, and educate them about why they need to lower their urate and how to do it. Pharmacists monitor lab results and titrate allopurinol as needed to hit serum urate levels of 6 mg/dL or less. The tune-up usually takes a year, at which point physicians resume ongoing management. The referring doctor is in the background to make sure everything goes okay.

It’s a simple, inexpensive approach that seems to help patients with a serious but notoriously undertreated condition. “It gives them the extra personal attention they might need. They appreciate the extra nudge most of the time,” said Kimberly Low, PharmD, the ambulatory pharmacist in an ongoing study of the approach at Kaiser Permanente Southern California in Pasadena (Contemp Clin Trials. 2016 Jul 20;50:106-15. doi: 10.1016/j.cct.2016.07.019).

“We need to deliver gout care in a more efficient way that doesn’t put it all on primary care,” where almost all gout is managed. “Pharmacy is a possible way to do that,” said Ted Mikuls, MD, a rheumatology professor at the University of Nebraska in Omaha, and senior investigator on the project. Results will be published soon.

The only randomized trial so far was published recently by Kaiser Permanente Northern California. The chance of hitting the 6-mg/dL mark at 6 months almost tripled when a pharmacist was involved. “The next step is to try to get a large-scale program funded using this model” at Kaiser, said lead investigator Robert Goldfien, MD, chair of the Chiefs of Rheumatology for the Permanente Medical Group in Richmond, Calif (Perm J. 2016 Jul 1;20[3]. doi: 10.7812/TPP/15-234).

Other places are turning to pharmacists, too, even when there isn’t a study involved. One of them is the San Diego Veterans Affairs Medical Center. It’s a “huge help; otherwise our clinic would be flooded with gout patients,” said rheumatologist Robert Terkeltaub, MD, who oversees the program.

Patients there are happy to have fewer flares and not to have to drive to the San Diego VA for blood draws; they go to a nearby clinic instead, and “we mail them their medications. We’ve had tremendous success” with pharmacists, and their “charges are affordable. We have treated hundreds of patients this way,” Dr. Terkeltaub said.

There doesn’t seem to be a downside. The only issue is how reimbursements will work. That’s not much of a problem when everyone is in the same health system and on the same electronic health record, with paychecks coming from the same place. Perhaps not surprisingly, large health systems are where the model is taking hold. How it could work with smaller practices and community pharmacists is unclear.

An obvious need

It’s no secret that gout care isn’t very good in the United States, or, really, anywhere else. Gout is a curable or at least imminently manageable condition with the right drugs for flares and lowering urate, but emergency department visits are up; hospitalizations for gout attacks have surpassed rheumatoid arthritis; and allopurinol dosing is routinely too low, if it’s prescribed at all.

Meanwhile, hyperuricemia has been linked to cardiovascular disease and other problems. Some now consider it part of the metabolic syndrome.

There are a lot of reasons why gout care is subpar, but one of them is that primary care providers are just too busy managing diabetes, hypertension, and other problems that seem more important in 10-minute office visits; that’s where pharmacists come in.

“They understand medications, drug-drug, and drug-herb interactions in a way that I don’t,” and also “have access, hopefully, to a more accurate picture of what patients take. I am all thumbs up for any involvement with pharmacists,” said Reid Blackwelder, MD, a recent president of the American Academy of Family Physicians and a family practice professor at East Tennessee State University in Mountain Home, where pharmacists are embedded in primary care.

Gout is a natural fit for pharmacy. Although the pharmacy-gout literature is thin, there have been plenty of reports about pharmacists improving outcomes, saving money, and increasing patient satisfaction when they help family practice and other doctors manage chronic problems. That’s one of the reasons why pharmacists are part of the primary care team in Mountain Home and other places that can afford them. Pharmacist-managed Coumadin clinics are the precedent.

“I think pharmacy is really excited about providing these types of services. Pharmacists managing gout patients is perfectly in line with what is going on now” in the field. “I can’t imagine how” outcomes “are not going to be positive,” said pharmacist Jan Hirsch, PhD, a professor of clinical pharmacy at the University of California, San Diego, where pharmacists are also on primary care teams.

Who’s going to pay?

No one wants a zero-sum game; physicians and pharmacists both need to be paid fairly for their services. The goal is collaborative care, not stealing patients.

Even so, the issue for a lot of primary care providers “will be who pays for this, and who doesn’t get paid when other people do this,” Dr. Blackwelder said.

One option outside of large health systems is for primary care practices to contract with a trusted local pharmacist to come in every few weeks to help with gout and other chronic problems.

Since they would be in the same office as the physician, family doctors could bill under their own name and split the payment with the pharmacist. “I would just contract with [pharmacists] personally,” Dr. Blackwelder said. “That way you don’t have to worry if the pharmacist” is considered “a provider or not” under Medicare Part B.

Meanwhile, Medicare Part D and some commercial plans reimburse for medication management, which is another option for pharmacist payments.

Additional options are likely to emerge, as well. “Payment models are evolving for pharmacists,” Dr. Hirsch said.

Dr. Mikuls disclosed pending research funding from AstraZeneca. Dr. Terkeltaub is a consultant for AstraZeneca, CymaBay, Revive, Relburn, and other companies.

[email protected]

Something new is being tried to improve gout outcomes in the United States: Pharmacists are being recruited to help manage patients.

People with too-high serum urate levels who agree to extra help are being referred to pharmacists empowered to order blood tests and allopurinol. Pharmacists contact patients by mail or phone, at first, and then maybe automated messages or emails, and educate them about why they need to lower their urate and how to do it. Pharmacists monitor lab results and titrate allopurinol as needed to hit serum urate levels of 6 mg/dL or less. The tune-up usually takes a year, at which point physicians resume ongoing management. The referring doctor is in the background to make sure everything goes okay.

It’s a simple, inexpensive approach that seems to help patients with a serious but notoriously undertreated condition. “It gives them the extra personal attention they might need. They appreciate the extra nudge most of the time,” said Kimberly Low, PharmD, the ambulatory pharmacist in an ongoing study of the approach at Kaiser Permanente Southern California in Pasadena (Contemp Clin Trials. 2016 Jul 20;50:106-15. doi: 10.1016/j.cct.2016.07.019).

“We need to deliver gout care in a more efficient way that doesn’t put it all on primary care,” where almost all gout is managed. “Pharmacy is a possible way to do that,” said Ted Mikuls, MD, a rheumatology professor at the University of Nebraska in Omaha, and senior investigator on the project. Results will be published soon.

The only randomized trial so far was published recently by Kaiser Permanente Northern California. The chance of hitting the 6-mg/dL mark at 6 months almost tripled when a pharmacist was involved. “The next step is to try to get a large-scale program funded using this model” at Kaiser, said lead investigator Robert Goldfien, MD, chair of the Chiefs of Rheumatology for the Permanente Medical Group in Richmond, Calif (Perm J. 2016 Jul 1;20[3]. doi: 10.7812/TPP/15-234).

Other places are turning to pharmacists, too, even when there isn’t a study involved. One of them is the San Diego Veterans Affairs Medical Center. It’s a “huge help; otherwise our clinic would be flooded with gout patients,” said rheumatologist Robert Terkeltaub, MD, who oversees the program.

Patients there are happy to have fewer flares and not to have to drive to the San Diego VA for blood draws; they go to a nearby clinic instead, and “we mail them their medications. We’ve had tremendous success” with pharmacists, and their “charges are affordable. We have treated hundreds of patients this way,” Dr. Terkeltaub said.

There doesn’t seem to be a downside. The only issue is how reimbursements will work. That’s not much of a problem when everyone is in the same health system and on the same electronic health record, with paychecks coming from the same place. Perhaps not surprisingly, large health systems are where the model is taking hold. How it could work with smaller practices and community pharmacists is unclear.

An obvious need

It’s no secret that gout care isn’t very good in the United States, or, really, anywhere else. Gout is a curable or at least imminently manageable condition with the right drugs for flares and lowering urate, but emergency department visits are up; hospitalizations for gout attacks have surpassed rheumatoid arthritis; and allopurinol dosing is routinely too low, if it’s prescribed at all.

Meanwhile, hyperuricemia has been linked to cardiovascular disease and other problems. Some now consider it part of the metabolic syndrome.

There are a lot of reasons why gout care is subpar, but one of them is that primary care providers are just too busy managing diabetes, hypertension, and other problems that seem more important in 10-minute office visits; that’s where pharmacists come in.

“They understand medications, drug-drug, and drug-herb interactions in a way that I don’t,” and also “have access, hopefully, to a more accurate picture of what patients take. I am all thumbs up for any involvement with pharmacists,” said Reid Blackwelder, MD, a recent president of the American Academy of Family Physicians and a family practice professor at East Tennessee State University in Mountain Home, where pharmacists are embedded in primary care.

Gout is a natural fit for pharmacy. Although the pharmacy-gout literature is thin, there have been plenty of reports about pharmacists improving outcomes, saving money, and increasing patient satisfaction when they help family practice and other doctors manage chronic problems. That’s one of the reasons why pharmacists are part of the primary care team in Mountain Home and other places that can afford them. Pharmacist-managed Coumadin clinics are the precedent.

“I think pharmacy is really excited about providing these types of services. Pharmacists managing gout patients is perfectly in line with what is going on now” in the field. “I can’t imagine how” outcomes “are not going to be positive,” said pharmacist Jan Hirsch, PhD, a professor of clinical pharmacy at the University of California, San Diego, where pharmacists are also on primary care teams.

Who’s going to pay?

No one wants a zero-sum game; physicians and pharmacists both need to be paid fairly for their services. The goal is collaborative care, not stealing patients.

Even so, the issue for a lot of primary care providers “will be who pays for this, and who doesn’t get paid when other people do this,” Dr. Blackwelder said.

One option outside of large health systems is for primary care practices to contract with a trusted local pharmacist to come in every few weeks to help with gout and other chronic problems.

Since they would be in the same office as the physician, family doctors could bill under their own name and split the payment with the pharmacist. “I would just contract with [pharmacists] personally,” Dr. Blackwelder said. “That way you don’t have to worry if the pharmacist” is considered “a provider or not” under Medicare Part B.

Meanwhile, Medicare Part D and some commercial plans reimburse for medication management, which is another option for pharmacist payments.

Additional options are likely to emerge, as well. “Payment models are evolving for pharmacists,” Dr. Hirsch said.

Dr. Mikuls disclosed pending research funding from AstraZeneca. Dr. Terkeltaub is a consultant for AstraZeneca, CymaBay, Revive, Relburn, and other companies.

[email protected]

Something new is being tried to improve gout outcomes in the United States: Pharmacists are being recruited to help manage patients.

People with too-high serum urate levels who agree to extra help are being referred to pharmacists empowered to order blood tests and allopurinol. Pharmacists contact patients by mail or phone, at first, and then maybe automated messages or emails, and educate them about why they need to lower their urate and how to do it. Pharmacists monitor lab results and titrate allopurinol as needed to hit serum urate levels of 6 mg/dL or less. The tune-up usually takes a year, at which point physicians resume ongoing management. The referring doctor is in the background to make sure everything goes okay.

It’s a simple, inexpensive approach that seems to help patients with a serious but notoriously undertreated condition. “It gives them the extra personal attention they might need. They appreciate the extra nudge most of the time,” said Kimberly Low, PharmD, the ambulatory pharmacist in an ongoing study of the approach at Kaiser Permanente Southern California in Pasadena (Contemp Clin Trials. 2016 Jul 20;50:106-15. doi: 10.1016/j.cct.2016.07.019).

“We need to deliver gout care in a more efficient way that doesn’t put it all on primary care,” where almost all gout is managed. “Pharmacy is a possible way to do that,” said Ted Mikuls, MD, a rheumatology professor at the University of Nebraska in Omaha, and senior investigator on the project. Results will be published soon.

The only randomized trial so far was published recently by Kaiser Permanente Northern California. The chance of hitting the 6-mg/dL mark at 6 months almost tripled when a pharmacist was involved. “The next step is to try to get a large-scale program funded using this model” at Kaiser, said lead investigator Robert Goldfien, MD, chair of the Chiefs of Rheumatology for the Permanente Medical Group in Richmond, Calif (Perm J. 2016 Jul 1;20[3]. doi: 10.7812/TPP/15-234).

Other places are turning to pharmacists, too, even when there isn’t a study involved. One of them is the San Diego Veterans Affairs Medical Center. It’s a “huge help; otherwise our clinic would be flooded with gout patients,” said rheumatologist Robert Terkeltaub, MD, who oversees the program.

Patients there are happy to have fewer flares and not to have to drive to the San Diego VA for blood draws; they go to a nearby clinic instead, and “we mail them their medications. We’ve had tremendous success” with pharmacists, and their “charges are affordable. We have treated hundreds of patients this way,” Dr. Terkeltaub said.

There doesn’t seem to be a downside. The only issue is how reimbursements will work. That’s not much of a problem when everyone is in the same health system and on the same electronic health record, with paychecks coming from the same place. Perhaps not surprisingly, large health systems are where the model is taking hold. How it could work with smaller practices and community pharmacists is unclear.

An obvious need

It’s no secret that gout care isn’t very good in the United States, or, really, anywhere else. Gout is a curable or at least imminently manageable condition with the right drugs for flares and lowering urate, but emergency department visits are up; hospitalizations for gout attacks have surpassed rheumatoid arthritis; and allopurinol dosing is routinely too low, if it’s prescribed at all.

Meanwhile, hyperuricemia has been linked to cardiovascular disease and other problems. Some now consider it part of the metabolic syndrome.

There are a lot of reasons why gout care is subpar, but one of them is that primary care providers are just too busy managing diabetes, hypertension, and other problems that seem more important in 10-minute office visits; that’s where pharmacists come in.

“They understand medications, drug-drug, and drug-herb interactions in a way that I don’t,” and also “have access, hopefully, to a more accurate picture of what patients take. I am all thumbs up for any involvement with pharmacists,” said Reid Blackwelder, MD, a recent president of the American Academy of Family Physicians and a family practice professor at East Tennessee State University in Mountain Home, where pharmacists are embedded in primary care.

Gout is a natural fit for pharmacy. Although the pharmacy-gout literature is thin, there have been plenty of reports about pharmacists improving outcomes, saving money, and increasing patient satisfaction when they help family practice and other doctors manage chronic problems. That’s one of the reasons why pharmacists are part of the primary care team in Mountain Home and other places that can afford them. Pharmacist-managed Coumadin clinics are the precedent.

“I think pharmacy is really excited about providing these types of services. Pharmacists managing gout patients is perfectly in line with what is going on now” in the field. “I can’t imagine how” outcomes “are not going to be positive,” said pharmacist Jan Hirsch, PhD, a professor of clinical pharmacy at the University of California, San Diego, where pharmacists are also on primary care teams.

Who’s going to pay?

No one wants a zero-sum game; physicians and pharmacists both need to be paid fairly for their services. The goal is collaborative care, not stealing patients.

Even so, the issue for a lot of primary care providers “will be who pays for this, and who doesn’t get paid when other people do this,” Dr. Blackwelder said.

One option outside of large health systems is for primary care practices to contract with a trusted local pharmacist to come in every few weeks to help with gout and other chronic problems.

Since they would be in the same office as the physician, family doctors could bill under their own name and split the payment with the pharmacist. “I would just contract with [pharmacists] personally,” Dr. Blackwelder said. “That way you don’t have to worry if the pharmacist” is considered “a provider or not” under Medicare Part B.

Meanwhile, Medicare Part D and some commercial plans reimburse for medication management, which is another option for pharmacist payments.

Additional options are likely to emerge, as well. “Payment models are evolving for pharmacists,” Dr. Hirsch said.

Dr. Mikuls disclosed pending research funding from AstraZeneca. Dr. Terkeltaub is a consultant for AstraZeneca, CymaBay, Revive, Relburn, and other companies.

[email protected]

BOSTON – Insect repellents containing DEET or picaridin are safe when used properly, and are important for bite protection in children, according to Mercedes E. Gonzalez, MD.

Insect bite reactions are common in children aged 2-10 years, and the emergence of Zika virus raises new concerns about the dangers of mosquito bites, in particular; the World Health Organization has declared Zika-related effects – namely microcephaly and Guillain-Barré syndrome – to be a “public health emergency of international concern.”

Thinkstock/Thinkstock.com

In children, illness associated with Zika virus is generally mild, but can include fever, rash, conjunctivitis, and/or arthralgia, Dr. Gonzalez said at the American Academy of Dermatology summer meeting.

DEET, used since 1957, is effective against mosquitoes, black flies, ticks, mites, and land leeches. It works by forming a vapor barrier that deters insects from coming into contact with the skin. The barrier extends about 4 cm from the skin. DEET can also be used on clothing but may cause damage to spandex, rayon, acetate, and leather, and can dissolve plastic and vinyl.

Although it is available in concentrations of 5%-100%, concentrations of 10%-35% provide adequate protection in most situations, said Dr. Gonzalez of the University of Miami.

Animal studies using large doses have shown that DEET is not a specific neurotoxin, and while there have been case reports of central nervous system toxicity in humans, there is no link to DEET dose or mechanistic pathway. Reported deaths have involved intentional ingestion and overuse or incorrect use of products, she said.

In fact, safety concerns are so minimal that the Environmental Protection Agency removed labels indicating caution in children, and the American Academy of Pediatrics recommends the use of DEET for preventing insect bites in children older than age 2 months, and in pregnant and lactating women.

One DEET safety concern, however, is flammability. Both DEET and the aerosol vehicle used in some DEET-containing products, are flammable, so caution is warranted, she said. Occlusion following use of DEET should also be avoided as it can increase absorption, and the product should be washed off after use.

Picaridin is another insect repellent that, like DEET, forms a vapor barrier to deter insects from getting close to the skin and biting, and can be used on both the skin and clothing, but it does not damage plastics or fabrics.

It has similar efficacy as DEET, and has a number of advantages over DEET in that it is odorless and does not feel sticky or greasy when applied. It has not been reported to cause any serious toxicity or mutagenesis.

Picaridin – which is effective against mosquitoes, dog and deer ticks, chiggers, and flies – has been used in Australia since 1998, and in the United States since 2005. That year, the Centers for Disease Control and Prevention recommended that it be used to protect against West Nile virus, and the World Health Organization said it was the best agent for preventing malaria, Dr. Gonzalez noted.

“So when [patients] ask about the best insect repellent, for most situations I do recommend DEET or picaridin, at 10%-25% for DEET, or 7%-15% for picaridin,” she said. She encourages people to read labels, noting that the EPA is encouraging the use of “repellency awareness” labels on insect repellents to inform the consumer whether it prevents against mosquitoes and/or ticks, and for how long.

It helps to provide specific recommendations, providing pictures and circling those that are recommended. Selling the products in the office is also a good idea to make sure patients “leave with the right product,” she said.

Also, advise patients about what to avoid, such as products that contain blends of natural plant oils, which have been shown to be ineffective, providing less than an hour of protection, she said.

Dr. Gonzalez also advises against the use of combination insect repellent/sunscreen products. One reason is that sunscreen needs frequent reapplication, while insect repellent does not. Further, studies have demonstrated that using sunscreen over insect repellent dramatically increases the percutaneous absorption of DEET, and reduces the SPF of the sunscreen. If both are needed, sunscreen should be applied first to reduce transdermal penetration of the active insect repellent ingredient, and should be reapplied every 2 hours, she said.

“Proper insect repellent use is just one part of protection,” she added.

Other measures that should be encouraged include the use of protective clothing, such as light cotton long sleeves and pants; avoidance of clothing with bright colors or flowery prints; avoidance of scented soaps, perfumes, or hair spray; removal of mosquito habitats by eliminating any standing water, covering gaps in doors, using screens and nets; and, if possible, staying indoors at sunrise, sunset, and early evening when mosquitoes are most active.

Dr. Gonzalez noted that many free resources are available online, including a tool at the epa.gov site that helps in selection of an appropriate product for one’s specific needs.

Dr. Gonzalez reported serving as a speaker and/or advisory board member and receiving honoraria from Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

[email protected]

BOSTON – Insect repellents containing DEET or picaridin are safe when used properly, and are important for bite protection in children, according to Mercedes E. Gonzalez, MD.

Insect bite reactions are common in children aged 2-10 years, and the emergence of Zika virus raises new concerns about the dangers of mosquito bites, in particular; the World Health Organization has declared Zika-related effects – namely microcephaly and Guillain-Barré syndrome – to be a “public health emergency of international concern.”

Thinkstock/Thinkstock.com

In children, illness associated with Zika virus is generally mild, but can include fever, rash, conjunctivitis, and/or arthralgia, Dr. Gonzalez said at the American Academy of Dermatology summer meeting.

DEET, used since 1957, is effective against mosquitoes, black flies, ticks, mites, and land leeches. It works by forming a vapor barrier that deters insects from coming into contact with the skin. The barrier extends about 4 cm from the skin. DEET can also be used on clothing but may cause damage to spandex, rayon, acetate, and leather, and can dissolve plastic and vinyl.

Although it is available in concentrations of 5%-100%, concentrations of 10%-35% provide adequate protection in most situations, said Dr. Gonzalez of the University of Miami.

Animal studies using large doses have shown that DEET is not a specific neurotoxin, and while there have been case reports of central nervous system toxicity in humans, there is no link to DEET dose or mechanistic pathway. Reported deaths have involved intentional ingestion and overuse or incorrect use of products, she said.

In fact, safety concerns are so minimal that the Environmental Protection Agency removed labels indicating caution in children, and the American Academy of Pediatrics recommends the use of DEET for preventing insect bites in children older than age 2 months, and in pregnant and lactating women.

One DEET safety concern, however, is flammability. Both DEET and the aerosol vehicle used in some DEET-containing products, are flammable, so caution is warranted, she said. Occlusion following use of DEET should also be avoided as it can increase absorption, and the product should be washed off after use.

Picaridin is another insect repellent that, like DEET, forms a vapor barrier to deter insects from getting close to the skin and biting, and can be used on both the skin and clothing, but it does not damage plastics or fabrics.

It has similar efficacy as DEET, and has a number of advantages over DEET in that it is odorless and does not feel sticky or greasy when applied. It has not been reported to cause any serious toxicity or mutagenesis.

Picaridin – which is effective against mosquitoes, dog and deer ticks, chiggers, and flies – has been used in Australia since 1998, and in the United States since 2005. That year, the Centers for Disease Control and Prevention recommended that it be used to protect against West Nile virus, and the World Health Organization said it was the best agent for preventing malaria, Dr. Gonzalez noted.

“So when [patients] ask about the best insect repellent, for most situations I do recommend DEET or picaridin, at 10%-25% for DEET, or 7%-15% for picaridin,” she said. She encourages people to read labels, noting that the EPA is encouraging the use of “repellency awareness” labels on insect repellents to inform the consumer whether it prevents against mosquitoes and/or ticks, and for how long.

It helps to provide specific recommendations, providing pictures and circling those that are recommended. Selling the products in the office is also a good idea to make sure patients “leave with the right product,” she said.

Also, advise patients about what to avoid, such as products that contain blends of natural plant oils, which have been shown to be ineffective, providing less than an hour of protection, she said.

Dr. Gonzalez also advises against the use of combination insect repellent/sunscreen products. One reason is that sunscreen needs frequent reapplication, while insect repellent does not. Further, studies have demonstrated that using sunscreen over insect repellent dramatically increases the percutaneous absorption of DEET, and reduces the SPF of the sunscreen. If both are needed, sunscreen should be applied first to reduce transdermal penetration of the active insect repellent ingredient, and should be reapplied every 2 hours, she said.

“Proper insect repellent use is just one part of protection,” she added.

Other measures that should be encouraged include the use of protective clothing, such as light cotton long sleeves and pants; avoidance of clothing with bright colors or flowery prints; avoidance of scented soaps, perfumes, or hair spray; removal of mosquito habitats by eliminating any standing water, covering gaps in doors, using screens and nets; and, if possible, staying indoors at sunrise, sunset, and early evening when mosquitoes are most active.

Dr. Gonzalez noted that many free resources are available online, including a tool at the epa.gov site that helps in selection of an appropriate product for one’s specific needs.

Dr. Gonzalez reported serving as a speaker and/or advisory board member and receiving honoraria from Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

[email protected]

BOSTON – Insect repellents containing DEET or picaridin are safe when used properly, and are important for bite protection in children, according to Mercedes E. Gonzalez, MD.

Insect bite reactions are common in children aged 2-10 years, and the emergence of Zika virus raises new concerns about the dangers of mosquito bites, in particular; the World Health Organization has declared Zika-related effects – namely microcephaly and Guillain-Barré syndrome – to be a “public health emergency of international concern.”

Thinkstock/Thinkstock.com

In children, illness associated with Zika virus is generally mild, but can include fever, rash, conjunctivitis, and/or arthralgia, Dr. Gonzalez said at the American Academy of Dermatology summer meeting.

DEET, used since 1957, is effective against mosquitoes, black flies, ticks, mites, and land leeches. It works by forming a vapor barrier that deters insects from coming into contact with the skin. The barrier extends about 4 cm from the skin. DEET can also be used on clothing but may cause damage to spandex, rayon, acetate, and leather, and can dissolve plastic and vinyl.

Although it is available in concentrations of 5%-100%, concentrations of 10%-35% provide adequate protection in most situations, said Dr. Gonzalez of the University of Miami.

Animal studies using large doses have shown that DEET is not a specific neurotoxin, and while there have been case reports of central nervous system toxicity in humans, there is no link to DEET dose or mechanistic pathway. Reported deaths have involved intentional ingestion and overuse or incorrect use of products, she said.

In fact, safety concerns are so minimal that the Environmental Protection Agency removed labels indicating caution in children, and the American Academy of Pediatrics recommends the use of DEET for preventing insect bites in children older than age 2 months, and in pregnant and lactating women.

One DEET safety concern, however, is flammability. Both DEET and the aerosol vehicle used in some DEET-containing products, are flammable, so caution is warranted, she said. Occlusion following use of DEET should also be avoided as it can increase absorption, and the product should be washed off after use.

Picaridin is another insect repellent that, like DEET, forms a vapor barrier to deter insects from getting close to the skin and biting, and can be used on both the skin and clothing, but it does not damage plastics or fabrics.

It has similar efficacy as DEET, and has a number of advantages over DEET in that it is odorless and does not feel sticky or greasy when applied. It has not been reported to cause any serious toxicity or mutagenesis.

Picaridin – which is effective against mosquitoes, dog and deer ticks, chiggers, and flies – has been used in Australia since 1998, and in the United States since 2005. That year, the Centers for Disease Control and Prevention recommended that it be used to protect against West Nile virus, and the World Health Organization said it was the best agent for preventing malaria, Dr. Gonzalez noted.

“So when [patients] ask about the best insect repellent, for most situations I do recommend DEET or picaridin, at 10%-25% for DEET, or 7%-15% for picaridin,” she said. She encourages people to read labels, noting that the EPA is encouraging the use of “repellency awareness” labels on insect repellents to inform the consumer whether it prevents against mosquitoes and/or ticks, and for how long.

It helps to provide specific recommendations, providing pictures and circling those that are recommended. Selling the products in the office is also a good idea to make sure patients “leave with the right product,” she said.

Also, advise patients about what to avoid, such as products that contain blends of natural plant oils, which have been shown to be ineffective, providing less than an hour of protection, she said.

Dr. Gonzalez also advises against the use of combination insect repellent/sunscreen products. One reason is that sunscreen needs frequent reapplication, while insect repellent does not. Further, studies have demonstrated that using sunscreen over insect repellent dramatically increases the percutaneous absorption of DEET, and reduces the SPF of the sunscreen. If both are needed, sunscreen should be applied first to reduce transdermal penetration of the active insect repellent ingredient, and should be reapplied every 2 hours, she said.

“Proper insect repellent use is just one part of protection,” she added.

Other measures that should be encouraged include the use of protective clothing, such as light cotton long sleeves and pants; avoidance of clothing with bright colors or flowery prints; avoidance of scented soaps, perfumes, or hair spray; removal of mosquito habitats by eliminating any standing water, covering gaps in doors, using screens and nets; and, if possible, staying indoors at sunrise, sunset, and early evening when mosquitoes are most active.

Dr. Gonzalez noted that many free resources are available online, including a tool at the epa.gov site that helps in selection of an appropriate product for one’s specific needs.

Dr. Gonzalez reported serving as a speaker and/or advisory board member and receiving honoraria from Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

[email protected]

SEATTLE – Additional resection to clear positive frozen tumor bed margins in oral cavity squamous cell carcinoma – a common practice in head and neck surgery – does not improve outcomes, investigators report.

In a retrospective review of 406 patients treated with oral cavity squamous cell carcinoma resection, the difference in local recurrence between patients with positive intraoperative frozen tumor bed margins cleared by additional resection (local recurrence in 27%) and those with positive frozen margins that were not cleared (local recurrence in 34%) was not statistically significant.

The team assessed local recurrence rates after dividing their review subjects – 61 years old on average and over half men – into those with negative tumor and tumor bed margins; patients with one positive and the other negative; and patients with both margins positive. Tumor beds were cleared to negative when possible.

The various configurations mattered for prognosis. Local recurrence ranged from 7% when both margins were negative to 65% when both were positive. Cancer recurred in 19% of patients with negative tumor but positive bed margins, and 35% of patients with positive tumor but negative bed margins. “Combining margin groups provides additional prognostic information, [but] the main specimen margin was the strongest predictor of recurrence. Positive margins on the main specimen carry a poor prognosis,” said lead investigator Marisa Buchakjian, MD, at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The study “should influence the use and interpretation of margin data in oral cavity squamous cell carcinoma surgery,” she said, since the majority of head and neck surgeons rely on tumor bed margins for prognosis, and consider positive tumor beds resected to clear pretty much the same as ones that are initially negative.

That approach is probably too simple. Intraoperative frozen tumor bed margins “were unreliable tests of main specimen margins, and would in fact be expected to miss approximately 50%” that are positive, said Dr. Buchakjian of University of Iowa Hospitals and Clinics, Iowa City.

She and her associates concluded that “the concordance between tumor bed and tumor specimen margins is not good ... Cases of main specimen margin involvement with no corresponding findings in tumor bed frozen sections are common; conversely, frozen sections may show involvement, while the main specimen margins are negative. Prognostic information is contained within findings from both the frozen and specimen margins,” and neither should be considered the “true” margin. The tumor margin is an important predictor, even if margins are taken from the tumor bed.

However, “we do not believe that this provides evidence that a known positive margin should not be pursued with additional excision. We emphasize that this study highlights the prognostic importance of margin status and that an involved margin, either on the initial tumor bed frozen sections or the tumor specimen, is associated with worse outcomes regardless of the final margin result,” they said.

The authors had no conflicts of interest, and didn’t report external funding.

[email protected]

SEATTLE – Additional resection to clear positive frozen tumor bed margins in oral cavity squamous cell carcinoma – a common practice in head and neck surgery – does not improve outcomes, investigators report.

In a retrospective review of 406 patients treated with oral cavity squamous cell carcinoma resection, the difference in local recurrence between patients with positive intraoperative frozen tumor bed margins cleared by additional resection (local recurrence in 27%) and those with positive frozen margins that were not cleared (local recurrence in 34%) was not statistically significant.

The team assessed local recurrence rates after dividing their review subjects – 61 years old on average and over half men – into those with negative tumor and tumor bed margins; patients with one positive and the other negative; and patients with both margins positive. Tumor beds were cleared to negative when possible.

The various configurations mattered for prognosis. Local recurrence ranged from 7% when both margins were negative to 65% when both were positive. Cancer recurred in 19% of patients with negative tumor but positive bed margins, and 35% of patients with positive tumor but negative bed margins. “Combining margin groups provides additional prognostic information, [but] the main specimen margin was the strongest predictor of recurrence. Positive margins on the main specimen carry a poor prognosis,” said lead investigator Marisa Buchakjian, MD, at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The study “should influence the use and interpretation of margin data in oral cavity squamous cell carcinoma surgery,” she said, since the majority of head and neck surgeons rely on tumor bed margins for prognosis, and consider positive tumor beds resected to clear pretty much the same as ones that are initially negative.

That approach is probably too simple. Intraoperative frozen tumor bed margins “were unreliable tests of main specimen margins, and would in fact be expected to miss approximately 50%” that are positive, said Dr. Buchakjian of University of Iowa Hospitals and Clinics, Iowa City.

She and her associates concluded that “the concordance between tumor bed and tumor specimen margins is not good ... Cases of main specimen margin involvement with no corresponding findings in tumor bed frozen sections are common; conversely, frozen sections may show involvement, while the main specimen margins are negative. Prognostic information is contained within findings from both the frozen and specimen margins,” and neither should be considered the “true” margin. The tumor margin is an important predictor, even if margins are taken from the tumor bed.

However, “we do not believe that this provides evidence that a known positive margin should not be pursued with additional excision. We emphasize that this study highlights the prognostic importance of margin status and that an involved margin, either on the initial tumor bed frozen sections or the tumor specimen, is associated with worse outcomes regardless of the final margin result,” they said.

The authors had no conflicts of interest, and didn’t report external funding.

[email protected]

SEATTLE – Additional resection to clear positive frozen tumor bed margins in oral cavity squamous cell carcinoma – a common practice in head and neck surgery – does not improve outcomes, investigators report.

In a retrospective review of 406 patients treated with oral cavity squamous cell carcinoma resection, the difference in local recurrence between patients with positive intraoperative frozen tumor bed margins cleared by additional resection (local recurrence in 27%) and those with positive frozen margins that were not cleared (local recurrence in 34%) was not statistically significant.

The team assessed local recurrence rates after dividing their review subjects – 61 years old on average and over half men – into those with negative tumor and tumor bed margins; patients with one positive and the other negative; and patients with both margins positive. Tumor beds were cleared to negative when possible.

The various configurations mattered for prognosis. Local recurrence ranged from 7% when both margins were negative to 65% when both were positive. Cancer recurred in 19% of patients with negative tumor but positive bed margins, and 35% of patients with positive tumor but negative bed margins. “Combining margin groups provides additional prognostic information, [but] the main specimen margin was the strongest predictor of recurrence. Positive margins on the main specimen carry a poor prognosis,” said lead investigator Marisa Buchakjian, MD, at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

The study “should influence the use and interpretation of margin data in oral cavity squamous cell carcinoma surgery,” she said, since the majority of head and neck surgeons rely on tumor bed margins for prognosis, and consider positive tumor beds resected to clear pretty much the same as ones that are initially negative.

That approach is probably too simple. Intraoperative frozen tumor bed margins “were unreliable tests of main specimen margins, and would in fact be expected to miss approximately 50%” that are positive, said Dr. Buchakjian of University of Iowa Hospitals and Clinics, Iowa City.

She and her associates concluded that “the concordance between tumor bed and tumor specimen margins is not good ... Cases of main specimen margin involvement with no corresponding findings in tumor bed frozen sections are common; conversely, frozen sections may show involvement, while the main specimen margins are negative. Prognostic information is contained within findings from both the frozen and specimen margins,” and neither should be considered the “true” margin. The tumor margin is an important predictor, even if margins are taken from the tumor bed.

However, “we do not believe that this provides evidence that a known positive margin should not be pursued with additional excision. We emphasize that this study highlights the prognostic importance of margin status and that an involved margin, either on the initial tumor bed frozen sections or the tumor specimen, is associated with worse outcomes regardless of the final margin result,” they said.

The authors had no conflicts of interest, and didn’t report external funding.

[email protected]

Junior-level residents are getting less operative experience in some common general surgery procedures, a large case review study has found.

The rise in laparoscopic surgery and the decline of open procedures have been accompanied by a reduction in junior resident participation in what previously would have been considered junior-level cases, reported Matthew Mullen, MD, and his associates at the department of surgery, University of Virginia, Charlottesville (J Surg Educ. 2016 August. doi: 10.1016/j.jsurg.2016.02.010).

©Comstock/Thinkstock

“The general response from the surgical community has been that this issue would correct over time, and the distribution of cases to junior residents would normalize,” the investigators explained. In the present study, the investigators “sought to evaluate continuing trends in case distribution among junior and senior residents.”

A total of 185,335 surgical cases performed between 2005 and 2012, identified through a query of the Participant Use Data File, were analyzed. Junior residents were defined as PGY1-3. Of the surgical cases reviewed, 30.2% were appendectomies, 21.9% were inguinal herniorrhaphies, 14.2% were colectomies, and 33.8% were cholecystectomy.

Over the 8-year period, 66% of those procedures were laparoscopic, and each year the likelihood of surgery being performed laparoscopically increased steadily for appendectomy, inguinal herniorrhaphy, and colectomy but remained the same for cholecystectomies.

In the same 8-year period, the likelihood of junior resident participation across all of these procedures decreased by an average of 5.3% per year. This decrease was most drastic for laparoscopic cholecystectomy at 6.2% per year while participation did not change for laparoscopic inguinal herniorrhaphy and increased by 3.9% for partial colectomy.

Junior level participation in open surgeries over the 8 years also decreased by 9.4% for appendectomy, 10% for inguinal herniorrhaphy, 2.9% for partial colectomy, and 4.1% for cholecystectomy.

Among the limitations of the study, the data did not show whether the lack of operative experience among junior residents was compensated for in their senior year or if these patterns differed between academic and community training environments.

“The reason for diminishing junior resident case volume for the basic general surgery procedures we examined is not truly known. It is possible that these common and technically straightforward cases, traditionally the training ground for junior residents, now require advanced laparoscopic skills and therefore are no longer appropriate for junior-level residents,” Dr. Mullen and his associates wrote.

Nonetheless, the decline of junior resident participation in these procedures will have significant implications for general surgery resident education, the investigators concluded.

This study was funded by the National Institutes of Health. Author disclosures were not reported.

Junior-level residents are getting less operative experience in some common general surgery procedures, a large case review study has found.

The rise in laparoscopic surgery and the decline of open procedures have been accompanied by a reduction in junior resident participation in what previously would have been considered junior-level cases, reported Matthew Mullen, MD, and his associates at the department of surgery, University of Virginia, Charlottesville (J Surg Educ. 2016 August. doi: 10.1016/j.jsurg.2016.02.010).

©Comstock/Thinkstock

“The general response from the surgical community has been that this issue would correct over time, and the distribution of cases to junior residents would normalize,” the investigators explained. In the present study, the investigators “sought to evaluate continuing trends in case distribution among junior and senior residents.”

A total of 185,335 surgical cases performed between 2005 and 2012, identified through a query of the Participant Use Data File, were analyzed. Junior residents were defined as PGY1-3. Of the surgical cases reviewed, 30.2% were appendectomies, 21.9% were inguinal herniorrhaphies, 14.2% were colectomies, and 33.8% were cholecystectomy.

Over the 8-year period, 66% of those procedures were laparoscopic, and each year the likelihood of surgery being performed laparoscopically increased steadily for appendectomy, inguinal herniorrhaphy, and colectomy but remained the same for cholecystectomies.

In the same 8-year period, the likelihood of junior resident participation across all of these procedures decreased by an average of 5.3% per year. This decrease was most drastic for laparoscopic cholecystectomy at 6.2% per year while participation did not change for laparoscopic inguinal herniorrhaphy and increased by 3.9% for partial colectomy.

Junior level participation in open surgeries over the 8 years also decreased by 9.4% for appendectomy, 10% for inguinal herniorrhaphy, 2.9% for partial colectomy, and 4.1% for cholecystectomy.

Among the limitations of the study, the data did not show whether the lack of operative experience among junior residents was compensated for in their senior year or if these patterns differed between academic and community training environments.

“The reason for diminishing junior resident case volume for the basic general surgery procedures we examined is not truly known. It is possible that these common and technically straightforward cases, traditionally the training ground for junior residents, now require advanced laparoscopic skills and therefore are no longer appropriate for junior-level residents,” Dr. Mullen and his associates wrote.

Nonetheless, the decline of junior resident participation in these procedures will have significant implications for general surgery resident education, the investigators concluded.

This study was funded by the National Institutes of Health. Author disclosures were not reported.

Junior-level residents are getting less operative experience in some common general surgery procedures, a large case review study has found.

The rise in laparoscopic surgery and the decline of open procedures have been accompanied by a reduction in junior resident participation in what previously would have been considered junior-level cases, reported Matthew Mullen, MD, and his associates at the department of surgery, University of Virginia, Charlottesville (J Surg Educ. 2016 August. doi: 10.1016/j.jsurg.2016.02.010).

©Comstock/Thinkstock

“The general response from the surgical community has been that this issue would correct over time, and the distribution of cases to junior residents would normalize,” the investigators explained. In the present study, the investigators “sought to evaluate continuing trends in case distribution among junior and senior residents.”

A total of 185,335 surgical cases performed between 2005 and 2012, identified through a query of the Participant Use Data File, were analyzed. Junior residents were defined as PGY1-3. Of the surgical cases reviewed, 30.2% were appendectomies, 21.9% were inguinal herniorrhaphies, 14.2% were colectomies, and 33.8% were cholecystectomy.

Over the 8-year period, 66% of those procedures were laparoscopic, and each year the likelihood of surgery being performed laparoscopically increased steadily for appendectomy, inguinal herniorrhaphy, and colectomy but remained the same for cholecystectomies.

In the same 8-year period, the likelihood of junior resident participation across all of these procedures decreased by an average of 5.3% per year. This decrease was most drastic for laparoscopic cholecystectomy at 6.2% per year while participation did not change for laparoscopic inguinal herniorrhaphy and increased by 3.9% for partial colectomy.

Junior level participation in open surgeries over the 8 years also decreased by 9.4% for appendectomy, 10% for inguinal herniorrhaphy, 2.9% for partial colectomy, and 4.1% for cholecystectomy.

Among the limitations of the study, the data did not show whether the lack of operative experience among junior residents was compensated for in their senior year or if these patterns differed between academic and community training environments.

“The reason for diminishing junior resident case volume for the basic general surgery procedures we examined is not truly known. It is possible that these common and technically straightforward cases, traditionally the training ground for junior residents, now require advanced laparoscopic skills and therefore are no longer appropriate for junior-level residents,” Dr. Mullen and his associates wrote.

Nonetheless, the decline of junior resident participation in these procedures will have significant implications for general surgery resident education, the investigators concluded.

This study was funded by the National Institutes of Health. Author disclosures were not reported.

(This column is the first in a three-part series.)

Question: Which of the following statements about state medical boards is best?

A. They are made up exclusively of doctors.

B. Disciplinary actions are on the rise.

C. They investigate narrowly defined areas of clinical practice.

D. They usually end with physician suspension.

E. They are insufficiently vigilant, according to critics.

Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.

All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.

Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.¹

State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.

There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.

In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.

On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.

However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.

For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.² Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.

The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”

Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.³ In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.

The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.

For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.

Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”⁴

The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.⁵

To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.

For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.

In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.

The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.

To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.

Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.

Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.

All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.

Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.⁶

These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.

References

1. U.S. Medical Regulatory Trends and Actions, May 2014.

2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).

3. In Re Kindschi, 52 Wn.2d 8 (1958).

4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.

5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.

6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

(This column is the first in a three-part series.)

Question: Which of the following statements about state medical boards is best?

A. They are made up exclusively of doctors.

B. Disciplinary actions are on the rise.

C. They investigate narrowly defined areas of clinical practice.

D. They usually end with physician suspension.

E. They are insufficiently vigilant, according to critics.

Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.

All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.

Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.¹

State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.

There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.

In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.

On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.

However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.

For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.² Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.

The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”

Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.³ In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.

The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.

For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.

Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”⁴

The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.⁵

To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.

For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.

In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.

The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.

To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.

Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.

Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.

All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.

Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.⁶

These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.

References

1. U.S. Medical Regulatory Trends and Actions, May 2014.

2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).

3. In Re Kindschi, 52 Wn.2d 8 (1958).

4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.

5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.

6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

(This column is the first in a three-part series.)

Question: Which of the following statements about state medical boards is best?

A. They are made up exclusively of doctors.

B. Disciplinary actions are on the rise.

C. They investigate narrowly defined areas of clinical practice.

D. They usually end with physician suspension.

E. They are insufficiently vigilant, according to critics.

Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.

All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.

Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.¹

State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.

There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.

In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.

On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.

However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.

For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.² Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.

The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”

Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.³ In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.

The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.

For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.

Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”⁴

The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.⁵

To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.

For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.

In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.

The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.

To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.

Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.

Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.

All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.

Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.⁶

These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.

References

1. U.S. Medical Regulatory Trends and Actions, May 2014.

2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).

3. In Re Kindschi, 52 Wn.2d 8 (1958).

4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.

5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.

6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

This month’s issue features coverage of a presentation by John Morton, MD, FACS, at the ACS National Surgical Quality Improvement Project annual meeting on the remarkable progress made over the past decade on bariatric surgery safety and patient satisfaction. The work in this area of quality improvement continues with the DROP project currently underway. See p

In this month’s From the Washington Office column, Patrick V. Bailey, MD, FACS, keeps the Fellows informed on the advocacy efforts to make sure the 2017 proposed Medicare Physician Fee Schedule does not impose unreasonable data collection burdens on surgeons. See p. 7

Meet our new co-Editors of ACS Surgery News, Karen E. Deveney, MD, FACS and Tyler G. Hughes, MD, FACS! These two surgeons are teaming up to oversee the content and direction of ACS Surgery News, replacing our esteemed former Editor-in-Chief, Layton F. Rikkers, MD, FACS. Dr. Rikkers is a tough act to follow, but our two new Editors are up to the challenge and I hope you will join me in welcoming them both. See p. 8

Use the mobile app to download or view as a pdf.

This month’s issue features coverage of a presentation by John Morton, MD, FACS, at the ACS National Surgical Quality Improvement Project annual meeting on the remarkable progress made over the past decade on bariatric surgery safety and patient satisfaction. The work in this area of quality improvement continues with the DROP project currently underway. See p

In this month’s From the Washington Office column, Patrick V. Bailey, MD, FACS, keeps the Fellows informed on the advocacy efforts to make sure the 2017 proposed Medicare Physician Fee Schedule does not impose unreasonable data collection burdens on surgeons. See p. 7

Meet our new co-Editors of ACS Surgery News, Karen E. Deveney, MD, FACS and Tyler G. Hughes, MD, FACS! These two surgeons are teaming up to oversee the content and direction of ACS Surgery News, replacing our esteemed former Editor-in-Chief, Layton F. Rikkers, MD, FACS. Dr. Rikkers is a tough act to follow, but our two new Editors are up to the challenge and I hope you will join me in welcoming them both. See p. 8

Use the mobile app to download or view as a pdf.

This month’s issue features coverage of a presentation by John Morton, MD, FACS, at the ACS National Surgical Quality Improvement Project annual meeting on the remarkable progress made over the past decade on bariatric surgery safety and patient satisfaction. The work in this area of quality improvement continues with the DROP project currently underway. See p

In this month’s From the Washington Office column, Patrick V. Bailey, MD, FACS, keeps the Fellows informed on the advocacy efforts to make sure the 2017 proposed Medicare Physician Fee Schedule does not impose unreasonable data collection burdens on surgeons. See p. 7

Meet our new co-Editors of ACS Surgery News, Karen E. Deveney, MD, FACS and Tyler G. Hughes, MD, FACS! These two surgeons are teaming up to oversee the content and direction of ACS Surgery News, replacing our esteemed former Editor-in-Chief, Layton F. Rikkers, MD, FACS. Dr. Rikkers is a tough act to follow, but our two new Editors are up to the challenge and I hope you will join me in welcoming them both. See p. 8

Use the mobile app to download or view as a pdf.

SAN DIEGO – A Food and Drug Administration official told diabetes educators that her agency is carefully monitoring the growth of an unusual development in diabetes care: the do-it-yourself artificial pancreas.

While the homemade insulin pumps are serving a need that has been unmet by manufacturers, the unregulated devices can be dangerous, according to Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices, who spoke at the annual meeting of the American Association of Diabetes Educators. “As they go toward a larger community, we see that the risk is raised.”

Still, “people are doing this because they feel this is the best way for them to help themselves or their children. We understand why people are doing it, but we want to make sure they do it safely,” Dr. Lias said.

At issue: The need for a “closed loop” artificial pancreas that needs little or no human intervention to measure blood sugar levels and deliver insulin as needed.

While current insulin pumps can deliver basal insulin continuously, users must program them to deliver an insulin bolus after meals or to address high blood sugar. Manufacturers are trying to develop a closed-loop artificial pancreas (also known as a bionic pancreas) that will simplify the process.

On their own, computer experts have been experimenting with jury-rigged homemade do-it-yourself (DIY) systems. “We recognize that for many PWDs [people with diabetes] the available help is not yet enough, so we are not waiting,” according to Dana Lewis and Scott Leibrand, two bloggers on a site called DIYPS.org.

In May 2016, The Wall Street Journal profiled a San Diego third-grader who uses a homemade “robotic pancreas” designed by his software engineer father. “More than 50 people have soldered, tinkered, and written software to make such devices for themselves or their children,” according to the Wall Street Journal report.

In her talk at the American Association of Diabetes Educators meeting, Dr. Lias noted that “there are a lot of questions about whether this is something that should be done.”

The algorithm behind a homemade device is one of area of concern, she said. “Who developed it and who’s responsible for having developed it? You may not understand how the algorithm is developed and what information is behind it. If something goes wrong, there’s no recourse.”

There are also questions about quality control, she noted: “Is there a responsible party for understanding things, for collecting information and making corrections?”

Dr. Lias said physicians should ask these questions if patients say they are using a DIY artificial pancreas: Do you understand exactly what algorithm is being used? Is it right for you? Have you checked the code to ensure it implements the algorithm correctly? Have you double-checked? When new, modified versions of code are shared, have you re-validated your entire system before implementing it?

It’s also important, she said, to note that these devices have not been determined to be safe and effective.

As the FDA monitors these DIY devices, Dr. Lias said, it’s also working to be ready to consider the work of manufacturers who are trying to develop the first commercial artificial pancreas device.

“Artificial pancreas devices do not have to be perfect with zero risk to be beneficial,” she says. “The approval decision is a benefit/risk decision. We make this decision in the context of the high risks that people with diabetes face every day.”

For now, she says, one focus is to make it easier for companies to work together to create the components of an artificial pancreas device.

The FDA is also concerned about what newly diagnosed people with diabetes will do if their devices break down, and they don’t know how to give themselves an insulin injection. “That’s a scenario that we will need to work out,” she said. “We’re talking with manufacturers about how they plan to work with that.”

SAN DIEGO – A Food and Drug Administration official told diabetes educators that her agency is carefully monitoring the growth of an unusual development in diabetes care: the do-it-yourself artificial pancreas.

While the homemade insulin pumps are serving a need that has been unmet by manufacturers, the unregulated devices can be dangerous, according to Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices, who spoke at the annual meeting of the American Association of Diabetes Educators. “As they go toward a larger community, we see that the risk is raised.”

Still, “people are doing this because they feel this is the best way for them to help themselves or their children. We understand why people are doing it, but we want to make sure they do it safely,” Dr. Lias said.

At issue: The need for a “closed loop” artificial pancreas that needs little or no human intervention to measure blood sugar levels and deliver insulin as needed.

While current insulin pumps can deliver basal insulin continuously, users must program them to deliver an insulin bolus after meals or to address high blood sugar. Manufacturers are trying to develop a closed-loop artificial pancreas (also known as a bionic pancreas) that will simplify the process.

On their own, computer experts have been experimenting with jury-rigged homemade do-it-yourself (DIY) systems. “We recognize that for many PWDs [people with diabetes] the available help is not yet enough, so we are not waiting,” according to Dana Lewis and Scott Leibrand, two bloggers on a site called DIYPS.org.

In May 2016, The Wall Street Journal profiled a San Diego third-grader who uses a homemade “robotic pancreas” designed by his software engineer father. “More than 50 people have soldered, tinkered, and written software to make such devices for themselves or their children,” according to the Wall Street Journal report.

In her talk at the American Association of Diabetes Educators meeting, Dr. Lias noted that “there are a lot of questions about whether this is something that should be done.”

The algorithm behind a homemade device is one of area of concern, she said. “Who developed it and who’s responsible for having developed it? You may not understand how the algorithm is developed and what information is behind it. If something goes wrong, there’s no recourse.”

There are also questions about quality control, she noted: “Is there a responsible party for understanding things, for collecting information and making corrections?”

Dr. Lias said physicians should ask these questions if patients say they are using a DIY artificial pancreas: Do you understand exactly what algorithm is being used? Is it right for you? Have you checked the code to ensure it implements the algorithm correctly? Have you double-checked? When new, modified versions of code are shared, have you re-validated your entire system before implementing it?

It’s also important, she said, to note that these devices have not been determined to be safe and effective.

As the FDA monitors these DIY devices, Dr. Lias said, it’s also working to be ready to consider the work of manufacturers who are trying to develop the first commercial artificial pancreas device.

“Artificial pancreas devices do not have to be perfect with zero risk to be beneficial,” she says. “The approval decision is a benefit/risk decision. We make this decision in the context of the high risks that people with diabetes face every day.”

For now, she says, one focus is to make it easier for companies to work together to create the components of an artificial pancreas device.

The FDA is also concerned about what newly diagnosed people with diabetes will do if their devices break down, and they don’t know how to give themselves an insulin injection. “That’s a scenario that we will need to work out,” she said. “We’re talking with manufacturers about how they plan to work with that.”

SAN DIEGO – A Food and Drug Administration official told diabetes educators that her agency is carefully monitoring the growth of an unusual development in diabetes care: the do-it-yourself artificial pancreas.

While the homemade insulin pumps are serving a need that has been unmet by manufacturers, the unregulated devices can be dangerous, according to Courtney Lias, PhD, director of the FDA’s Division of Chemistry and Toxicology Devices, who spoke at the annual meeting of the American Association of Diabetes Educators. “As they go toward a larger community, we see that the risk is raised.”

Still, “people are doing this because they feel this is the best way for them to help themselves or their children. We understand why people are doing it, but we want to make sure they do it safely,” Dr. Lias said.

At issue: The need for a “closed loop” artificial pancreas that needs little or no human intervention to measure blood sugar levels and deliver insulin as needed.

While current insulin pumps can deliver basal insulin continuously, users must program them to deliver an insulin bolus after meals or to address high blood sugar. Manufacturers are trying to develop a closed-loop artificial pancreas (also known as a bionic pancreas) that will simplify the process.

On their own, computer experts have been experimenting with jury-rigged homemade do-it-yourself (DIY) systems. “We recognize that for many PWDs [people with diabetes] the available help is not yet enough, so we are not waiting,” according to Dana Lewis and Scott Leibrand, two bloggers on a site called DIYPS.org.

In May 2016, The Wall Street Journal profiled a San Diego third-grader who uses a homemade “robotic pancreas” designed by his software engineer father. “More than 50 people have soldered, tinkered, and written software to make such devices for themselves or their children,” according to the Wall Street Journal report.

In her talk at the American Association of Diabetes Educators meeting, Dr. Lias noted that “there are a lot of questions about whether this is something that should be done.”

The algorithm behind a homemade device is one of area of concern, she said. “Who developed it and who’s responsible for having developed it? You may not understand how the algorithm is developed and what information is behind it. If something goes wrong, there’s no recourse.”

There are also questions about quality control, she noted: “Is there a responsible party for understanding things, for collecting information and making corrections?”

Dr. Lias said physicians should ask these questions if patients say they are using a DIY artificial pancreas: Do you understand exactly what algorithm is being used? Is it right for you? Have you checked the code to ensure it implements the algorithm correctly? Have you double-checked? When new, modified versions of code are shared, have you re-validated your entire system before implementing it?

It’s also important, she said, to note that these devices have not been determined to be safe and effective.

As the FDA monitors these DIY devices, Dr. Lias said, it’s also working to be ready to consider the work of manufacturers who are trying to develop the first commercial artificial pancreas device.

“Artificial pancreas devices do not have to be perfect with zero risk to be beneficial,” she says. “The approval decision is a benefit/risk decision. We make this decision in the context of the high risks that people with diabetes face every day.”

For now, she says, one focus is to make it easier for companies to work together to create the components of an artificial pancreas device.

The FDA is also concerned about what newly diagnosed people with diabetes will do if their devices break down, and they don’t know how to give themselves an insulin injection. “That’s a scenario that we will need to work out,” she said. “We’re talking with manufacturers about how they plan to work with that.”

April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA

President & Annual Meeting Chair
Thoralf M. Sundt, III

Annual Meeting Co-Chairs
Robert D. Jaquiss
Bryan F. Meyers

Reflecting on the Past. Building Our Future. Always Learning.

Please join us in Boston to celebrate the AATS Centennial.

Attendees will commemorate the first 100 years of the AATS and cardiothoracic surgery by enjoying activities and events, as well as viewing historical artifacts and memorabilia.

Celebrate How Far We Have Come: The Centennial officially begins with the Welcome Reception in the Exhibit Hall.

Celebrate Our Leadership: “In the Words of the Presidents” — a commemorative text containing personal reminiscences from most recent AATS past presidents — will be provided to all professional attendees.

Celebrate Our Specialty: The once-in-a-lifetime Centennial Gala will be held at the famed Wang Theatre in the heart of Boston. This black tie affair will include a cocktail reception, sit-down dinner on the stage, and performances from local musicians from prestigious Boston institutes.

Celebrate Our History: “In the Beginning” is a documentary film providing an in-depth look at the formative years of and challenges faced by cardiothoracic surgery. The film includes interviews with past presidents and members of the Centennial Committee.

April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA

President & Annual Meeting Chair
Thoralf M. Sundt, III

Annual Meeting Co-Chairs
Robert D. Jaquiss
Bryan F. Meyers

Reflecting on the Past. Building Our Future. Always Learning.

Please join us in Boston to celebrate the AATS Centennial.

Attendees will commemorate the first 100 years of the AATS and cardiothoracic surgery by enjoying activities and events, as well as viewing historical artifacts and memorabilia.

Celebrate How Far We Have Come: The Centennial officially begins with the Welcome Reception in the Exhibit Hall.

Celebrate Our Leadership: “In the Words of the Presidents” — a commemorative text containing personal reminiscences from most recent AATS past presidents — will be provided to all professional attendees.

Celebrate Our Specialty: The once-in-a-lifetime Centennial Gala will be held at the famed Wang Theatre in the heart of Boston. This black tie affair will include a cocktail reception, sit-down dinner on the stage, and performances from local musicians from prestigious Boston institutes.

Celebrate Our History: “In the Beginning” is a documentary film providing an in-depth look at the formative years of and challenges faced by cardiothoracic surgery. The film includes interviews with past presidents and members of the Centennial Committee.

April 29 – May 3, 2017
Boston Hynes Convention Center
Boston, MA

President & Annual Meeting Chair
Thoralf M. Sundt, III

Annual Meeting Co-Chairs
Robert D. Jaquiss
Bryan F. Meyers

Reflecting on the Past. Building Our Future. Always Learning.

Please join us in Boston to celebrate the AATS Centennial.

Attendees will commemorate the first 100 years of the AATS and cardiothoracic surgery by enjoying activities and events, as well as viewing historical artifacts and memorabilia.

Celebrate How Far We Have Come: The Centennial officially begins with the Welcome Reception in the Exhibit Hall.

Celebrate Our Leadership: “In the Words of the Presidents” — a commemorative text containing personal reminiscences from most recent AATS past presidents — will be provided to all professional attendees.

Celebrate Our Specialty: The once-in-a-lifetime Centennial Gala will be held at the famed Wang Theatre in the heart of Boston. This black tie affair will include a cocktail reception, sit-down dinner on the stage, and performances from local musicians from prestigious Boston institutes.

Celebrate Our History: “In the Beginning” is a documentary film providing an in-depth look at the formative years of and challenges faced by cardiothoracic surgery. The film includes interviews with past presidents and members of the Centennial Committee.