Upadacitinib (Rinvoq) has been approved by the Food and Drug Administration for treatment of adults with moderately to severely active RA, according to a release from its developer. The indication specifies that patients must have shown inadequate response or intolerance to methotrexate.

The approval is based on the SELECT program, which included 4,400 patients across five studies that tested the oral Janus kinase inhibitor in various settings, such as alone or with methotrexate. All primary and secondary endpoints were met in these trials. For example, among patients with inadequate response to methotrexate in one study, 68% of those treated with 15-mg upadacitinib monotherapy achieved 20% improvement in American College of Rheumatology response criteria (ACR20) at week 14 versus 41% of those who had continued on methotrexate. In another study of patients with in adequate response to methotrexate, 71% of those treated with upadacitinib/methotrexate combination therapy achieved ACR20 at week 12 versus 36% of those receiving placebo and methotrexate. Compared with other treatments, better rates of clinical remission and radiographic inhibition were seen with upadacitinib-based therapies, too.

Upadacitinib carries a boxed warning – the most serious warning the FDA issues – for risks of serious infection, malignancy, and thrombosis; these serious risks should be weighed against treatment benefits in any patients with increased risk for these problems or currently experiencing any of them. Concomitant use with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants is not recommended; its use also is not recommended for patients with severe hepatic impairment. The most common adverse reactions are upper respiratory tract infection, nausea, cough, and pyrexia. Live vaccines should be avoided with patients taking this drug, and patients who are breastfeeding should be advised against use of it.

More prescribing information can be found in the drug’s label, which can be found on the FDA’s website.

Upadacitinib is also being evaluated for treatment of other immune-mediated diseases.

[email protected]

Upadacitinib (Rinvoq) has been approved by the Food and Drug Administration for treatment of adults with moderately to severely active RA, according to a release from its developer. The indication specifies that patients must have shown inadequate response or intolerance to methotrexate.

The approval is based on the SELECT program, which included 4,400 patients across five studies that tested the oral Janus kinase inhibitor in various settings, such as alone or with methotrexate. All primary and secondary endpoints were met in these trials. For example, among patients with inadequate response to methotrexate in one study, 68% of those treated with 15-mg upadacitinib monotherapy achieved 20% improvement in American College of Rheumatology response criteria (ACR20) at week 14 versus 41% of those who had continued on methotrexate. In another study of patients with in adequate response to methotrexate, 71% of those treated with upadacitinib/methotrexate combination therapy achieved ACR20 at week 12 versus 36% of those receiving placebo and methotrexate. Compared with other treatments, better rates of clinical remission and radiographic inhibition were seen with upadacitinib-based therapies, too.

Upadacitinib carries a boxed warning – the most serious warning the FDA issues – for risks of serious infection, malignancy, and thrombosis; these serious risks should be weighed against treatment benefits in any patients with increased risk for these problems or currently experiencing any of them. Concomitant use with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants is not recommended; its use also is not recommended for patients with severe hepatic impairment. The most common adverse reactions are upper respiratory tract infection, nausea, cough, and pyrexia. Live vaccines should be avoided with patients taking this drug, and patients who are breastfeeding should be advised against use of it.

More prescribing information can be found in the drug’s label, which can be found on the FDA’s website.

Upadacitinib is also being evaluated for treatment of other immune-mediated diseases.

[email protected]

Upadacitinib (Rinvoq) has been approved by the Food and Drug Administration for treatment of adults with moderately to severely active RA, according to a release from its developer. The indication specifies that patients must have shown inadequate response or intolerance to methotrexate.

The approval is based on the SELECT program, which included 4,400 patients across five studies that tested the oral Janus kinase inhibitor in various settings, such as alone or with methotrexate. All primary and secondary endpoints were met in these trials. For example, among patients with inadequate response to methotrexate in one study, 68% of those treated with 15-mg upadacitinib monotherapy achieved 20% improvement in American College of Rheumatology response criteria (ACR20) at week 14 versus 41% of those who had continued on methotrexate. In another study of patients with in adequate response to methotrexate, 71% of those treated with upadacitinib/methotrexate combination therapy achieved ACR20 at week 12 versus 36% of those receiving placebo and methotrexate. Compared with other treatments, better rates of clinical remission and radiographic inhibition were seen with upadacitinib-based therapies, too.

Upadacitinib carries a boxed warning – the most serious warning the FDA issues – for risks of serious infection, malignancy, and thrombosis; these serious risks should be weighed against treatment benefits in any patients with increased risk for these problems or currently experiencing any of them. Concomitant use with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants is not recommended; its use also is not recommended for patients with severe hepatic impairment. The most common adverse reactions are upper respiratory tract infection, nausea, cough, and pyrexia. Live vaccines should be avoided with patients taking this drug, and patients who are breastfeeding should be advised against use of it.

More prescribing information can be found in the drug’s label, which can be found on the FDA’s website.

Upadacitinib is also being evaluated for treatment of other immune-mediated diseases.

[email protected]

The EHR system at the hospital occasionally argues with me about my orders.

kokouu/iStockphoto

I may order a brain MRI, or CT angiography, or pretty much anything, and when I click to submit it a box pops up, telling me I shouldn’t be ordering that.

Sometimes it’s based on cost, saying that the MRI is more expensive than a CT, and according to some internal algorithm I should do that instead. Other times it says the test isn’t appropriate given the patient’s condition, age, zodiac sign, whatever. It might also say the test is redundant, because the patient just had a brain MRI during an admission last month.

I ignore them. There’s an override button to close the box and order the test, and that’s what I always click.

I have no objection to a reasonable review, but neither the computer nor its algorithms went through medical school, or residency, or read journals regularly, or have 20 years of experience in this field. I’d like to think (or hope) I know what I’m doing.

I don’t take this job lightly. When I order a test it’s because I’m trying to do the right thing for the patient. To find out what’s going on. To see what I can do to treat them. In short, to help as much as I can within the limitations of modern medical practice. Sometimes those things don’t always involve saving the insurance company money, or trying to get by with a previous study’s results.

Medicine is not a cookbook. While guidelines can be useful, every patient is different, and treatment plans have to be adjusted accordingly. It would be nice if this was the one-size-fits-all world the computer algorithms would like, but patient care is anything but.

I’d also rather “overcare” than “undercare.” To me, that’s just good practice. If I follow the computer’s advice and provide less care than needed and miss something, I’m pretty sure “because the computer told me not to” isn’t going to stand up as a defense in court.

I’m going to just keep on practicing medicine using, as one of my past attendings would say, “clinical correlation” and keeping what’s best for the patient in mind. Anything less may be fine for the computer, but not for me, and certainly not for those I’m trying to help.

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

The EHR system at the hospital occasionally argues with me about my orders.

kokouu/iStockphoto

I may order a brain MRI, or CT angiography, or pretty much anything, and when I click to submit it a box pops up, telling me I shouldn’t be ordering that.

Sometimes it’s based on cost, saying that the MRI is more expensive than a CT, and according to some internal algorithm I should do that instead. Other times it says the test isn’t appropriate given the patient’s condition, age, zodiac sign, whatever. It might also say the test is redundant, because the patient just had a brain MRI during an admission last month.

I ignore them. There’s an override button to close the box and order the test, and that’s what I always click.

I have no objection to a reasonable review, but neither the computer nor its algorithms went through medical school, or residency, or read journals regularly, or have 20 years of experience in this field. I’d like to think (or hope) I know what I’m doing.

I don’t take this job lightly. When I order a test it’s because I’m trying to do the right thing for the patient. To find out what’s going on. To see what I can do to treat them. In short, to help as much as I can within the limitations of modern medical practice. Sometimes those things don’t always involve saving the insurance company money, or trying to get by with a previous study’s results.

Medicine is not a cookbook. While guidelines can be useful, every patient is different, and treatment plans have to be adjusted accordingly. It would be nice if this was the one-size-fits-all world the computer algorithms would like, but patient care is anything but.

I’d also rather “overcare” than “undercare.” To me, that’s just good practice. If I follow the computer’s advice and provide less care than needed and miss something, I’m pretty sure “because the computer told me not to” isn’t going to stand up as a defense in court.

I’m going to just keep on practicing medicine using, as one of my past attendings would say, “clinical correlation” and keeping what’s best for the patient in mind. Anything less may be fine for the computer, but not for me, and certainly not for those I’m trying to help.

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

The EHR system at the hospital occasionally argues with me about my orders.

kokouu/iStockphoto

I may order a brain MRI, or CT angiography, or pretty much anything, and when I click to submit it a box pops up, telling me I shouldn’t be ordering that.

Sometimes it’s based on cost, saying that the MRI is more expensive than a CT, and according to some internal algorithm I should do that instead. Other times it says the test isn’t appropriate given the patient’s condition, age, zodiac sign, whatever. It might also say the test is redundant, because the patient just had a brain MRI during an admission last month.

I ignore them. There’s an override button to close the box and order the test, and that’s what I always click.

I have no objection to a reasonable review, but neither the computer nor its algorithms went through medical school, or residency, or read journals regularly, or have 20 years of experience in this field. I’d like to think (or hope) I know what I’m doing.

I don’t take this job lightly. When I order a test it’s because I’m trying to do the right thing for the patient. To find out what’s going on. To see what I can do to treat them. In short, to help as much as I can within the limitations of modern medical practice. Sometimes those things don’t always involve saving the insurance company money, or trying to get by with a previous study’s results.

Medicine is not a cookbook. While guidelines can be useful, every patient is different, and treatment plans have to be adjusted accordingly. It would be nice if this was the one-size-fits-all world the computer algorithms would like, but patient care is anything but.

I’d also rather “overcare” than “undercare.” To me, that’s just good practice. If I follow the computer’s advice and provide less care than needed and miss something, I’m pretty sure “because the computer told me not to” isn’t going to stand up as a defense in court.

I’m going to just keep on practicing medicine using, as one of my past attendings would say, “clinical correlation” and keeping what’s best for the patient in mind. Anything less may be fine for the computer, but not for me, and certainly not for those I’m trying to help.

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

Two new guidelines on the treatment and prevention of migraines in children and adolescents have been released by the American Academy of Neurology and the American Headache Society.

This update to the previous guidelines released by the American Academy of Neurology in 2004 reflects the expansion in pharmacologic and nonpharmacologic approaches during the last 15 years, Andrew D. Hershey, MD, PhD, director of the division of neurology at Cincinnati Children’s Hospital and a fellow of the American Academy of Neurology, said in an interview.

“There has also been an increase in the number of randomized controlled studies, which have allowed for a more robust statement on acute and preventive treatments to be made,” said Dr. Hershey, who is also a senior author for both guidelines.

The two reports focused on separate issues: One guideline outlined the options for treatment of acute migraine, and the second guideline summarized the available studies on the effectiveness of preventive medications for migraine in children and adolescents.

The guidelines recommend a physical examination and history to establish a specific headache diagnosis and afford a treatment that provides fast and complete pain relief. Treatment should be initiated as soon as a patient realizes an attack is occurring. Patients with signs of secondary headache should be evaluated by a neurologist or a headache specialist.

Studies support the use of ibuprofen and acetaminophen for pain relief in cases of acute migraine, but only some triptans (such as almotriptan, rizatriptan, sumatriptan/naproxen, and zolmitriptan nasal spray) are approved for use in adolescents. Specifically, sumatriptan/naproxen was shown to be effective when compared with placebo in studies with adolescents, whose headache symptoms resolved within 2 hours.

It may be necessary to try more than one triptan, the guidelines noted, because patients respond differently to medications. A failure to respond to one triptan does not necessarily mean that treatment with another triptan will be unsuccessful.

The guidelines also focused on patient and family education to improve medication safety and adherence. Lifestyle modification, avoidance of migraine triggers, creating good sleep habits, and staying hydrated can help reduce migraines. While no medications improved associated symptoms of migraines such as nausea or vomiting, triptans did show a benefit in reducing phonophobia and photophobia.

Evidence for pharmacologic prevention of migraines in children and adolescents is limited, according to the guidelines. In the 15 studies included in a literature review, there was not sufficient evidence to show preventive treatments, such as divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, and flunarizine, were more effective than placebo at reducing the frequency of headaches. There was some evidence to show propranolol in children and topiramate and cinnarizine in children and adolescents can reduce headache frequency. Children and adolescents who received cognitive-behavioral therapy together with amitriptyline were more likely to have reduced frequency of headaches than were those who received amitriptyline with patient education.

“The consensus conclusion was that a multidisciplinary approach that combines acute treatments, preventive treatments, and healthy habits is likely to have the best outcomes,” said Dr. Hershey.

Dr. Hershey acknowledged the many gaps between what is clinically observed and what the studies in the guidelines demonstrated.

“One of the biggest questions is how to minimize the expectation response in the controlled studies,” he said. “Additionally, we are moving toward a better recognition of the mechanism by which the various treatments work in a genetic-based disease that is polygenic in nature” with up to 38 different gene polymorphisms identified to date.

The guidelines also do not address newer treatments, such as calcitonin gene–related peptide (CGRP) antibodies, CGRP antagonists, serotonin antagonists, and devices because there are as yet no studies of their effectiveness in children and adolescents.

“They have been studied in adults, so will be prone to the expectation response; but given the large number of diverse therapies, one can hope that many of the gaps can be filled,” said Dr. Hershey.

The American Academy of Neurology provided funding for development of the guidelines and reimbursed authors who served as subcommittee members for travel expenses and in-person meetings. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, grants, honorariums, consultancies, and publishing royalties for pharmaceutical companies and other organizations.

SOURCES: Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008095. Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008105.

Two new guidelines on the treatment and prevention of migraines in children and adolescents have been released by the American Academy of Neurology and the American Headache Society.

This update to the previous guidelines released by the American Academy of Neurology in 2004 reflects the expansion in pharmacologic and nonpharmacologic approaches during the last 15 years, Andrew D. Hershey, MD, PhD, director of the division of neurology at Cincinnati Children’s Hospital and a fellow of the American Academy of Neurology, said in an interview.

“There has also been an increase in the number of randomized controlled studies, which have allowed for a more robust statement on acute and preventive treatments to be made,” said Dr. Hershey, who is also a senior author for both guidelines.

The two reports focused on separate issues: One guideline outlined the options for treatment of acute migraine, and the second guideline summarized the available studies on the effectiveness of preventive medications for migraine in children and adolescents.

The guidelines recommend a physical examination and history to establish a specific headache diagnosis and afford a treatment that provides fast and complete pain relief. Treatment should be initiated as soon as a patient realizes an attack is occurring. Patients with signs of secondary headache should be evaluated by a neurologist or a headache specialist.

Studies support the use of ibuprofen and acetaminophen for pain relief in cases of acute migraine, but only some triptans (such as almotriptan, rizatriptan, sumatriptan/naproxen, and zolmitriptan nasal spray) are approved for use in adolescents. Specifically, sumatriptan/naproxen was shown to be effective when compared with placebo in studies with adolescents, whose headache symptoms resolved within 2 hours.

It may be necessary to try more than one triptan, the guidelines noted, because patients respond differently to medications. A failure to respond to one triptan does not necessarily mean that treatment with another triptan will be unsuccessful.

The guidelines also focused on patient and family education to improve medication safety and adherence. Lifestyle modification, avoidance of migraine triggers, creating good sleep habits, and staying hydrated can help reduce migraines. While no medications improved associated symptoms of migraines such as nausea or vomiting, triptans did show a benefit in reducing phonophobia and photophobia.

Evidence for pharmacologic prevention of migraines in children and adolescents is limited, according to the guidelines. In the 15 studies included in a literature review, there was not sufficient evidence to show preventive treatments, such as divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, and flunarizine, were more effective than placebo at reducing the frequency of headaches. There was some evidence to show propranolol in children and topiramate and cinnarizine in children and adolescents can reduce headache frequency. Children and adolescents who received cognitive-behavioral therapy together with amitriptyline were more likely to have reduced frequency of headaches than were those who received amitriptyline with patient education.

“The consensus conclusion was that a multidisciplinary approach that combines acute treatments, preventive treatments, and healthy habits is likely to have the best outcomes,” said Dr. Hershey.

Dr. Hershey acknowledged the many gaps between what is clinically observed and what the studies in the guidelines demonstrated.

“One of the biggest questions is how to minimize the expectation response in the controlled studies,” he said. “Additionally, we are moving toward a better recognition of the mechanism by which the various treatments work in a genetic-based disease that is polygenic in nature” with up to 38 different gene polymorphisms identified to date.

The guidelines also do not address newer treatments, such as calcitonin gene–related peptide (CGRP) antibodies, CGRP antagonists, serotonin antagonists, and devices because there are as yet no studies of their effectiveness in children and adolescents.

“They have been studied in adults, so will be prone to the expectation response; but given the large number of diverse therapies, one can hope that many of the gaps can be filled,” said Dr. Hershey.

The American Academy of Neurology provided funding for development of the guidelines and reimbursed authors who served as subcommittee members for travel expenses and in-person meetings. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, grants, honorariums, consultancies, and publishing royalties for pharmaceutical companies and other organizations.

SOURCES: Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008095. Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008105.

Two new guidelines on the treatment and prevention of migraines in children and adolescents have been released by the American Academy of Neurology and the American Headache Society.

This update to the previous guidelines released by the American Academy of Neurology in 2004 reflects the expansion in pharmacologic and nonpharmacologic approaches during the last 15 years, Andrew D. Hershey, MD, PhD, director of the division of neurology at Cincinnati Children’s Hospital and a fellow of the American Academy of Neurology, said in an interview.

“There has also been an increase in the number of randomized controlled studies, which have allowed for a more robust statement on acute and preventive treatments to be made,” said Dr. Hershey, who is also a senior author for both guidelines.

The two reports focused on separate issues: One guideline outlined the options for treatment of acute migraine, and the second guideline summarized the available studies on the effectiveness of preventive medications for migraine in children and adolescents.

The guidelines recommend a physical examination and history to establish a specific headache diagnosis and afford a treatment that provides fast and complete pain relief. Treatment should be initiated as soon as a patient realizes an attack is occurring. Patients with signs of secondary headache should be evaluated by a neurologist or a headache specialist.

Studies support the use of ibuprofen and acetaminophen for pain relief in cases of acute migraine, but only some triptans (such as almotriptan, rizatriptan, sumatriptan/naproxen, and zolmitriptan nasal spray) are approved for use in adolescents. Specifically, sumatriptan/naproxen was shown to be effective when compared with placebo in studies with adolescents, whose headache symptoms resolved within 2 hours.

It may be necessary to try more than one triptan, the guidelines noted, because patients respond differently to medications. A failure to respond to one triptan does not necessarily mean that treatment with another triptan will be unsuccessful.

The guidelines also focused on patient and family education to improve medication safety and adherence. Lifestyle modification, avoidance of migraine triggers, creating good sleep habits, and staying hydrated can help reduce migraines. While no medications improved associated symptoms of migraines such as nausea or vomiting, triptans did show a benefit in reducing phonophobia and photophobia.

Evidence for pharmacologic prevention of migraines in children and adolescents is limited, according to the guidelines. In the 15 studies included in a literature review, there was not sufficient evidence to show preventive treatments, such as divalproex, onabotulinumtoxinA, amitriptyline, nimodipine, and flunarizine, were more effective than placebo at reducing the frequency of headaches. There was some evidence to show propranolol in children and topiramate and cinnarizine in children and adolescents can reduce headache frequency. Children and adolescents who received cognitive-behavioral therapy together with amitriptyline were more likely to have reduced frequency of headaches than were those who received amitriptyline with patient education.

“The consensus conclusion was that a multidisciplinary approach that combines acute treatments, preventive treatments, and healthy habits is likely to have the best outcomes,” said Dr. Hershey.

Dr. Hershey acknowledged the many gaps between what is clinically observed and what the studies in the guidelines demonstrated.

“One of the biggest questions is how to minimize the expectation response in the controlled studies,” he said. “Additionally, we are moving toward a better recognition of the mechanism by which the various treatments work in a genetic-based disease that is polygenic in nature” with up to 38 different gene polymorphisms identified to date.

The guidelines also do not address newer treatments, such as calcitonin gene–related peptide (CGRP) antibodies, CGRP antagonists, serotonin antagonists, and devices because there are as yet no studies of their effectiveness in children and adolescents.

“They have been studied in adults, so will be prone to the expectation response; but given the large number of diverse therapies, one can hope that many of the gaps can be filled,” said Dr. Hershey.

The American Academy of Neurology provided funding for development of the guidelines and reimbursed authors who served as subcommittee members for travel expenses and in-person meetings. The authors reported personal and institutional relationships in the form of advisory board memberships, investigator appointments, speakers bureau positions, research support, grants, honorariums, consultancies, and publishing royalties for pharmaceutical companies and other organizations.

SOURCES: Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008095. Oskoui M et al. Neurology. 2019 Aug 14. doi: 10.1212/WNL.0000000000008105.

PHILADELPHIA – The oral, small molecule, calcitonin gene-related peptide receptor antagonist ubrogepant, currently under regulatory review for approval as a treatment for acute migraine headache, was as effective for migraine relief in patients with a history of triptan ineffectiveness as it was in patients for whom triptans had been effective, based on a post hoc analysis of data collected from 1,798 patients enrolled in two phase 3 trials.

Mitchel L. Zoler/MDedge News

In the roughly one-quarter of all patients who had a clinical history consistent with triptan ineffectiveness, one 50-mg dose of ubrogepant led to pain freedom 2 hours after treatment in 16% of patients, compared with a response rate of 8% in placebo-treated patients. Ubrogepant’s effectiveness rate that was about the same as seen in patients with a history of triptan effectiveness, who were about 37% of the study population, Susan Hutchinson, MD, said at the annual meeting of the American Headache Society.

Among those with a history of triptan effectiveness, 20% were pain free after 2 hours, compared with 11% of placebo-treated controls, said Dr. Hutchinson, a family physician and headache specialist who practices in Irvine, Calif. Both of these between-group differences were statistically significant. The remaining patients included in the analysis had no triptan history, and among these patients a single, 50-mg dose of ubrogepant produced pain freedom at 2 hours in 24% of patients, versus an 18% response in placebo-treated controls, a difference that fell short of statistical significance.

The analysis Dr. Hutchinson reported came from data collected in two pivotal trials of ubrogepant for treatment of an acute migraine headache, the ACHIEVE I and ACHIEVE II trials, which together randomized more than 2,600 migraine patients eligible for the study’s modified intention-to-treat analysis, and 1,798 patients from that analysis who received a 50-mg dose of ubrogepant or placebo. In March 2019, the company developing ubrogepant, Allergan, announced that the Food and Drug Administration had accepted the company’s application for marketing approval of ubrogepant as a treatment for acute migraine largely based on data from ACHIEVE I and ACHIEVE II.

The researchers defined a history of triptan ineffectiveness as a patient who never used a triptan because of a warning, precaution, or contraindication, a patient who recently used triptans but did not achieve pain freedom within 2 hours more than half the time taking the drugs, or a patient who no longer used triptans because of adverse effects or lack of efficacy. Patients who had used triptans in the past and had complete pain relief within 2 hours more than half the time were deemed triptan-effective patients.

The analysis also looked at two other endpoints in addition to complete pain freedom: complete relief of the most-bothersome symptom of the migraine headache (photophobia for most patients), which resolved in 39% and 36% of the triptan-effective and triptan-ineffective patients, respectively, compared with placebo response rates of 27% and 23%; both between-group differences were statistically significant. A third measure of efficacy was some degree of pain relief after 2 hours, which occurred in 62% of patients in whom triptans were effective and 55% in those in whom triptans were ineffective, which were again statistically significant higher rates than among patients who received placebo.

Safety findings from the two ubrogepant pivotal trials showed good drug tolerability, with no treatment-related serious adverse events, and a profile of modest numbers of treatment-related and total adverse events similar to what occurred among patients who received placebo.

ACHIEVE I and II were funded by Allergan, the company developing ubrogepant. Dr. Hutchinson has been an adviser to and a speaker on behalf of Allergan and several other companies.

[email protected]

SOURCE: Blumenfeld AM. Headache. 2019 June;59[S1]:1-208, Abstract IOR02.

PHILADELPHIA – The oral, small molecule, calcitonin gene-related peptide receptor antagonist ubrogepant, currently under regulatory review for approval as a treatment for acute migraine headache, was as effective for migraine relief in patients with a history of triptan ineffectiveness as it was in patients for whom triptans had been effective, based on a post hoc analysis of data collected from 1,798 patients enrolled in two phase 3 trials.

Mitchel L. Zoler/MDedge News

In the roughly one-quarter of all patients who had a clinical history consistent with triptan ineffectiveness, one 50-mg dose of ubrogepant led to pain freedom 2 hours after treatment in 16% of patients, compared with a response rate of 8% in placebo-treated patients. Ubrogepant’s effectiveness rate that was about the same as seen in patients with a history of triptan effectiveness, who were about 37% of the study population, Susan Hutchinson, MD, said at the annual meeting of the American Headache Society.

Among those with a history of triptan effectiveness, 20% were pain free after 2 hours, compared with 11% of placebo-treated controls, said Dr. Hutchinson, a family physician and headache specialist who practices in Irvine, Calif. Both of these between-group differences were statistically significant. The remaining patients included in the analysis had no triptan history, and among these patients a single, 50-mg dose of ubrogepant produced pain freedom at 2 hours in 24% of patients, versus an 18% response in placebo-treated controls, a difference that fell short of statistical significance.

The analysis Dr. Hutchinson reported came from data collected in two pivotal trials of ubrogepant for treatment of an acute migraine headache, the ACHIEVE I and ACHIEVE II trials, which together randomized more than 2,600 migraine patients eligible for the study’s modified intention-to-treat analysis, and 1,798 patients from that analysis who received a 50-mg dose of ubrogepant or placebo. In March 2019, the company developing ubrogepant, Allergan, announced that the Food and Drug Administration had accepted the company’s application for marketing approval of ubrogepant as a treatment for acute migraine largely based on data from ACHIEVE I and ACHIEVE II.

The researchers defined a history of triptan ineffectiveness as a patient who never used a triptan because of a warning, precaution, or contraindication, a patient who recently used triptans but did not achieve pain freedom within 2 hours more than half the time taking the drugs, or a patient who no longer used triptans because of adverse effects or lack of efficacy. Patients who had used triptans in the past and had complete pain relief within 2 hours more than half the time were deemed triptan-effective patients.

The analysis also looked at two other endpoints in addition to complete pain freedom: complete relief of the most-bothersome symptom of the migraine headache (photophobia for most patients), which resolved in 39% and 36% of the triptan-effective and triptan-ineffective patients, respectively, compared with placebo response rates of 27% and 23%; both between-group differences were statistically significant. A third measure of efficacy was some degree of pain relief after 2 hours, which occurred in 62% of patients in whom triptans were effective and 55% in those in whom triptans were ineffective, which were again statistically significant higher rates than among patients who received placebo.

Safety findings from the two ubrogepant pivotal trials showed good drug tolerability, with no treatment-related serious adverse events, and a profile of modest numbers of treatment-related and total adverse events similar to what occurred among patients who received placebo.

ACHIEVE I and II were funded by Allergan, the company developing ubrogepant. Dr. Hutchinson has been an adviser to and a speaker on behalf of Allergan and several other companies.

[email protected]

SOURCE: Blumenfeld AM. Headache. 2019 June;59[S1]:1-208, Abstract IOR02.

PHILADELPHIA – The oral, small molecule, calcitonin gene-related peptide receptor antagonist ubrogepant, currently under regulatory review for approval as a treatment for acute migraine headache, was as effective for migraine relief in patients with a history of triptan ineffectiveness as it was in patients for whom triptans had been effective, based on a post hoc analysis of data collected from 1,798 patients enrolled in two phase 3 trials.

Mitchel L. Zoler/MDedge News

In the roughly one-quarter of all patients who had a clinical history consistent with triptan ineffectiveness, one 50-mg dose of ubrogepant led to pain freedom 2 hours after treatment in 16% of patients, compared with a response rate of 8% in placebo-treated patients. Ubrogepant’s effectiveness rate that was about the same as seen in patients with a history of triptan effectiveness, who were about 37% of the study population, Susan Hutchinson, MD, said at the annual meeting of the American Headache Society.

Among those with a history of triptan effectiveness, 20% were pain free after 2 hours, compared with 11% of placebo-treated controls, said Dr. Hutchinson, a family physician and headache specialist who practices in Irvine, Calif. Both of these between-group differences were statistically significant. The remaining patients included in the analysis had no triptan history, and among these patients a single, 50-mg dose of ubrogepant produced pain freedom at 2 hours in 24% of patients, versus an 18% response in placebo-treated controls, a difference that fell short of statistical significance.

The analysis Dr. Hutchinson reported came from data collected in two pivotal trials of ubrogepant for treatment of an acute migraine headache, the ACHIEVE I and ACHIEVE II trials, which together randomized more than 2,600 migraine patients eligible for the study’s modified intention-to-treat analysis, and 1,798 patients from that analysis who received a 50-mg dose of ubrogepant or placebo. In March 2019, the company developing ubrogepant, Allergan, announced that the Food and Drug Administration had accepted the company’s application for marketing approval of ubrogepant as a treatment for acute migraine largely based on data from ACHIEVE I and ACHIEVE II.

The researchers defined a history of triptan ineffectiveness as a patient who never used a triptan because of a warning, precaution, or contraindication, a patient who recently used triptans but did not achieve pain freedom within 2 hours more than half the time taking the drugs, or a patient who no longer used triptans because of adverse effects or lack of efficacy. Patients who had used triptans in the past and had complete pain relief within 2 hours more than half the time were deemed triptan-effective patients.

The analysis also looked at two other endpoints in addition to complete pain freedom: complete relief of the most-bothersome symptom of the migraine headache (photophobia for most patients), which resolved in 39% and 36% of the triptan-effective and triptan-ineffective patients, respectively, compared with placebo response rates of 27% and 23%; both between-group differences were statistically significant. A third measure of efficacy was some degree of pain relief after 2 hours, which occurred in 62% of patients in whom triptans were effective and 55% in those in whom triptans were ineffective, which were again statistically significant higher rates than among patients who received placebo.

Safety findings from the two ubrogepant pivotal trials showed good drug tolerability, with no treatment-related serious adverse events, and a profile of modest numbers of treatment-related and total adverse events similar to what occurred among patients who received placebo.

ACHIEVE I and II were funded by Allergan, the company developing ubrogepant. Dr. Hutchinson has been an adviser to and a speaker on behalf of Allergan and several other companies.

[email protected]

SOURCE: Blumenfeld AM. Headache. 2019 June;59[S1]:1-208, Abstract IOR02.

The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.

Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.

“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.

Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.

“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has expanded the indication for the Sapien 3, Sapien 3 Ultra, CoreValve Evolut R, and CoreValve Evolut PRO transcatheter heart valves to include patients with severe aortic valve stenosis at low risk for death or major complications associated with open-heart surgery.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The announcement was based on results of a pair of clinical trials involving patients with severe aortic valve stenosis. In the first, 1,000 patients were randomly sorted to receive either transcatheter aortic valve replacement (TAVR) with the Edwards Lifescience’s Sapien 3 device or open-heart surgery. In the second, 1,468 patients received either Medtronic’s CoreValve Evolut R or CoreValve Evolut PRO or open heart surgery. In both studies, after an average follow-up time of 15-17 months, outcomes such as all-cause mortality and stroke were similar in patients who underwent open heart surgery and who received the transcatheter heart valve.

Serious adverse events associated with transcatheter heart valves include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. Patients who cannot tolerate blood-thinning medication or have an infection in the heart are contraindicated; in addition, the CoreValve devices should not be used in patients sensitive to titanium or nickel. Because the longevity of transcatheter heart valves, compared with open-heart surgery, has not been established, younger patients should discuss options with their health care provider.

“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the press release.

Find the full press release on the FDA website.

[email protected]

The United States and Canada deliver health care in different ways, and patterns of prescription drug use also vary between the two countries, according to the National Center for Health Statistics.

The populations of the two countries, however, have similar age distributions – adults aged 40-79 years made up 44% of the population in the United States and 48% in Canada in 2016 – so “monitoring the use of prescription drugs provides insights into the health and health care of U.S. and Canadian adults,” the NCHS investigators wrote.

Data from the 2015-2016 National Health and Nutritional Examination Survey show that 15% of Americans aged 40-59 years had used antidepressants in the past 30 days, putting them ahead of lipid-lowering drugs (14%) and ACE inhibitors (11%), the NCHS said in a recent Data Brief.

Analgesics were the leading drug type in Canada, with 10% of adults aged 40-59 years reporting use in the past month, although that’s still lower than in the United States (11%), where they were fourth in popularity. The American top two were second and third among Canadians, while proton pump inhibitors were fourth in Canada but did not crack the top five in the United States, the NCHS reported based on 2016-2017 data from the Canadian Health Measures Survey.

Past 30-day use of the most common prescription drug types

Older adults (60-79 years) in the two countries managed to share some common ground: Lipid-lowering drugs were the most commonly used prescription medication both north and south of the border, although past 30-day use was considerably higher in the United States (45% vs. 34%), the NCHS investigators said.

There were differences to be found, however, in the older age group. Analgesics were the second most commonly used drug type in Canada but did not even reach the top five in the United States, while beta-blockers were third among Americans but missed the Canadian top five, they noted.

Americans aged 40-59 years were significantly more likely than Canadians to have used at least one prescription drug of any type in the past 30 days (60% vs. 53%) and to have used at least five such drugs (15% vs. 10%). The differences among adults aged 60-79 were not significant, although American use was higher for at least one drug (84% vs. 83%) and for at least five (35% vs. 31%), according to the report.

[email protected]

The United States and Canada deliver health care in different ways, and patterns of prescription drug use also vary between the two countries, according to the National Center for Health Statistics.

The populations of the two countries, however, have similar age distributions – adults aged 40-79 years made up 44% of the population in the United States and 48% in Canada in 2016 – so “monitoring the use of prescription drugs provides insights into the health and health care of U.S. and Canadian adults,” the NCHS investigators wrote.

Data from the 2015-2016 National Health and Nutritional Examination Survey show that 15% of Americans aged 40-59 years had used antidepressants in the past 30 days, putting them ahead of lipid-lowering drugs (14%) and ACE inhibitors (11%), the NCHS said in a recent Data Brief.

Analgesics were the leading drug type in Canada, with 10% of adults aged 40-59 years reporting use in the past month, although that’s still lower than in the United States (11%), where they were fourth in popularity. The American top two were second and third among Canadians, while proton pump inhibitors were fourth in Canada but did not crack the top five in the United States, the NCHS reported based on 2016-2017 data from the Canadian Health Measures Survey.

Past 30-day use of the most common prescription drug types

Older adults (60-79 years) in the two countries managed to share some common ground: Lipid-lowering drugs were the most commonly used prescription medication both north and south of the border, although past 30-day use was considerably higher in the United States (45% vs. 34%), the NCHS investigators said.

There were differences to be found, however, in the older age group. Analgesics were the second most commonly used drug type in Canada but did not even reach the top five in the United States, while beta-blockers were third among Americans but missed the Canadian top five, they noted.

Americans aged 40-59 years were significantly more likely than Canadians to have used at least one prescription drug of any type in the past 30 days (60% vs. 53%) and to have used at least five such drugs (15% vs. 10%). The differences among adults aged 60-79 were not significant, although American use was higher for at least one drug (84% vs. 83%) and for at least five (35% vs. 31%), according to the report.

[email protected]

The United States and Canada deliver health care in different ways, and patterns of prescription drug use also vary between the two countries, according to the National Center for Health Statistics.

The populations of the two countries, however, have similar age distributions – adults aged 40-79 years made up 44% of the population in the United States and 48% in Canada in 2016 – so “monitoring the use of prescription drugs provides insights into the health and health care of U.S. and Canadian adults,” the NCHS investigators wrote.

Data from the 2015-2016 National Health and Nutritional Examination Survey show that 15% of Americans aged 40-59 years had used antidepressants in the past 30 days, putting them ahead of lipid-lowering drugs (14%) and ACE inhibitors (11%), the NCHS said in a recent Data Brief.

Analgesics were the leading drug type in Canada, with 10% of adults aged 40-59 years reporting use in the past month, although that’s still lower than in the United States (11%), where they were fourth in popularity. The American top two were second and third among Canadians, while proton pump inhibitors were fourth in Canada but did not crack the top five in the United States, the NCHS reported based on 2016-2017 data from the Canadian Health Measures Survey.

Past 30-day use of the most common prescription drug types

Older adults (60-79 years) in the two countries managed to share some common ground: Lipid-lowering drugs were the most commonly used prescription medication both north and south of the border, although past 30-day use was considerably higher in the United States (45% vs. 34%), the NCHS investigators said.

There were differences to be found, however, in the older age group. Analgesics were the second most commonly used drug type in Canada but did not even reach the top five in the United States, while beta-blockers were third among Americans but missed the Canadian top five, they noted.

Americans aged 40-59 years were significantly more likely than Canadians to have used at least one prescription drug of any type in the past 30 days (60% vs. 53%) and to have used at least five such drugs (15% vs. 10%). The differences among adults aged 60-79 were not significant, although American use was higher for at least one drug (84% vs. 83%) and for at least five (35% vs. 31%), according to the report.

[email protected]

It’s a typically busy Friday and the doctor is running 20 minutes behind schedule. He enters the next exam room and the sight of the patient makes him forget the apology he had prepared.

C5Media/Getty Images

The 10 month old looks miserable. Red eyes. Snot dripping from his nose. A red rash that extends from his face and involves most of the chest, arms, and upper thighs.

“When did this start?” he asks the mother as he searches for a surgical mask in the cabinet next to the exam table.

“Two days after we returned from our vacation in France,” the worried young woman replies. “Do you think it could be measles?”

Between Jan. 1 and Aug. 8, 2019, 1,182 cases of measles had been confirmed in the United States. That’s more than three times the number of cases reported in all of 2018, and the highest number of cases reported in a single year in more than a quarter century. While 75% of the cases this year have been linked to outbreaks in New York, individuals from 30 states have been affected.

Given the widespread nature of the outbreak, it makes sense for every ambulatory office to have a plan for managing exposures to infectious diseases including measles. With measles in particular, time is limited to deliver effective postexposure prophylaxis and prevent the spread of measles in the community, making it difficult to develop a plan on the fly.

Schedule strategically. You don’t want a patient with measles hanging out in your waiting room. According to the American Academy of Pediatrics, measures to prevent the transmission of contagious infectious agents in ambulatory facilities begin at the time the visit is scheduled. When there is measles transmission in the community, consider using a standardized script when scheduling patients that includes questions about fever, rash, other symptoms typical for measles, and possible exposures. Some offices will have procedures in place that can be adapted to care for patients with suspected measles. When a patient presents for suspected chicken pox, do you advise them to come at the end of the day to minimize exposures? Enter through a side door? Perform a car visit?

Triage promptly. Mask patients with fever and rash, move to a private room, and close the door.

Once measles is suspected, only health care personnel who are immune to measles should enter the exam room. According to the Centers for Disease Control and Prevention, presumptive evidence of measles immunity in health care providers is written documentation of vaccination with two doses of live measles or MMR vaccine administered at least 28 days apart, laboratory evidence of immunity (that is, positive measles IgG), laboratory confirmation of disease, or birth before 1957.

Even though health care providers born before 1957 are presumed to have had the disease at some point and have traditionally been considered immune, the CDC suggests that health care facilities consider giving these individuals two doses of MMR vaccine unless they have prior laboratory confirmation of disease immunity. Do you know who in your office is immune or would you need to scramble if you had an exposure?

When measles is suspected, health care personnel should wear an N-95 if they have been fit tested and the appropriate mask is available. Practically, most ambulatory offices do not stock N-95 masks and the next best choice is a regular surgical mask.

Order the recommended tests to confirm the diagnosis, but do not wait for the results to confirm the diagnosis. The CDC recommends testing serum for IgM antibodies and sending a throat or nasopharyngeal swab to look for the virus by polymerase chain reaction testing. Measles virus also is shed in the urine so collecting a urine specimen for testing may increase the chances of finding the virus. Depending on where you practice, the tests may take 3 days or more to result. Contact your local health department as soon as you consider a measles diagnosis.

Discharge patients home or transferred to a higher level of care if this is necessary as quickly as possible. Fortunately, most patients with measles do not require hospitalization. Do not send patients to the hospital simply for the purpose of laboratory testing if this can be accomplished quickly in your office or for evaluation by other providers. This just creates the potential for more exposures. If a patient does require higher-level care, provider-to-provider communication about the suspected diagnosis and the need for airborne isolation should take place.

Keep the door closed. Once a patient with suspected measles is discharged from a regular exam room, the door should remain closed, and it should not be used for at least 1 hour. Remember that infectious virus can remain in the air for 1-2 hours after a patient leaves an area. The same is true for the waiting room.

Develop the exposure list. In general, patients and family members who were in the waiting room at the same time as the index patient and up to 1-2 hours after the index patient left are considered exposed. Measles is highly contagious and 9 out of 10 susceptible people who are exposed will develop disease. How many infants aged less than 1 year might be in your waiting room at any given time? How many immunocompromised patients or family members? Public health authorities can help determine who needs prophylaxis.

Don’t get anxious and start testing everyone for measles, especially patients who lack typical signs and symptoms or exposures. Ordering a test in a patient who has a low likelihood of measles is more likely to result in a false-positive test than a true-positive test. False-positive measles IgM tests can be seen with some viral infections, including parvovirus and Epstein-Barr. Some rheumatologic disorders also can contribute to false-positive tests.

Review your office procedure for vaccine counseling. The 10 month old with measles in the opening vignette should have been given an MMR vaccine before travel. The vaccine is recommended for infants aged 6-11 months who are traveling outside the United States, but it doesn’t count toward the vaccine series. Reimmunize young travelers at 12-15 months and again at 4-6 years. The CDC has developed a toolkit that contains resources for taking to parents about vaccines. It is available at https://www.cdc.gov/measles/toolkit/healthcare-providers.html.

It’s a typically busy Friday and the doctor is running 20 minutes behind schedule. He enters the next exam room and the sight of the patient makes him forget the apology he had prepared.

C5Media/Getty Images

The 10 month old looks miserable. Red eyes. Snot dripping from his nose. A red rash that extends from his face and involves most of the chest, arms, and upper thighs.

“When did this start?” he asks the mother as he searches for a surgical mask in the cabinet next to the exam table.

“Two days after we returned from our vacation in France,” the worried young woman replies. “Do you think it could be measles?”

Between Jan. 1 and Aug. 8, 2019, 1,182 cases of measles had been confirmed in the United States. That’s more than three times the number of cases reported in all of 2018, and the highest number of cases reported in a single year in more than a quarter century. While 75% of the cases this year have been linked to outbreaks in New York, individuals from 30 states have been affected.

Given the widespread nature of the outbreak, it makes sense for every ambulatory office to have a plan for managing exposures to infectious diseases including measles. With measles in particular, time is limited to deliver effective postexposure prophylaxis and prevent the spread of measles in the community, making it difficult to develop a plan on the fly.

Schedule strategically. You don’t want a patient with measles hanging out in your waiting room. According to the American Academy of Pediatrics, measures to prevent the transmission of contagious infectious agents in ambulatory facilities begin at the time the visit is scheduled. When there is measles transmission in the community, consider using a standardized script when scheduling patients that includes questions about fever, rash, other symptoms typical for measles, and possible exposures. Some offices will have procedures in place that can be adapted to care for patients with suspected measles. When a patient presents for suspected chicken pox, do you advise them to come at the end of the day to minimize exposures? Enter through a side door? Perform a car visit?

Triage promptly. Mask patients with fever and rash, move to a private room, and close the door.

Once measles is suspected, only health care personnel who are immune to measles should enter the exam room. According to the Centers for Disease Control and Prevention, presumptive evidence of measles immunity in health care providers is written documentation of vaccination with two doses of live measles or MMR vaccine administered at least 28 days apart, laboratory evidence of immunity (that is, positive measles IgG), laboratory confirmation of disease, or birth before 1957.

Even though health care providers born before 1957 are presumed to have had the disease at some point and have traditionally been considered immune, the CDC suggests that health care facilities consider giving these individuals two doses of MMR vaccine unless they have prior laboratory confirmation of disease immunity. Do you know who in your office is immune or would you need to scramble if you had an exposure?

When measles is suspected, health care personnel should wear an N-95 if they have been fit tested and the appropriate mask is available. Practically, most ambulatory offices do not stock N-95 masks and the next best choice is a regular surgical mask.

Order the recommended tests to confirm the diagnosis, but do not wait for the results to confirm the diagnosis. The CDC recommends testing serum for IgM antibodies and sending a throat or nasopharyngeal swab to look for the virus by polymerase chain reaction testing. Measles virus also is shed in the urine so collecting a urine specimen for testing may increase the chances of finding the virus. Depending on where you practice, the tests may take 3 days or more to result. Contact your local health department as soon as you consider a measles diagnosis.

Discharge patients home or transferred to a higher level of care if this is necessary as quickly as possible. Fortunately, most patients with measles do not require hospitalization. Do not send patients to the hospital simply for the purpose of laboratory testing if this can be accomplished quickly in your office or for evaluation by other providers. This just creates the potential for more exposures. If a patient does require higher-level care, provider-to-provider communication about the suspected diagnosis and the need for airborne isolation should take place.

Keep the door closed. Once a patient with suspected measles is discharged from a regular exam room, the door should remain closed, and it should not be used for at least 1 hour. Remember that infectious virus can remain in the air for 1-2 hours after a patient leaves an area. The same is true for the waiting room.

Develop the exposure list. In general, patients and family members who were in the waiting room at the same time as the index patient and up to 1-2 hours after the index patient left are considered exposed. Measles is highly contagious and 9 out of 10 susceptible people who are exposed will develop disease. How many infants aged less than 1 year might be in your waiting room at any given time? How many immunocompromised patients or family members? Public health authorities can help determine who needs prophylaxis.

Don’t get anxious and start testing everyone for measles, especially patients who lack typical signs and symptoms or exposures. Ordering a test in a patient who has a low likelihood of measles is more likely to result in a false-positive test than a true-positive test. False-positive measles IgM tests can be seen with some viral infections, including parvovirus and Epstein-Barr. Some rheumatologic disorders also can contribute to false-positive tests.

Review your office procedure for vaccine counseling. The 10 month old with measles in the opening vignette should have been given an MMR vaccine before travel. The vaccine is recommended for infants aged 6-11 months who are traveling outside the United States, but it doesn’t count toward the vaccine series. Reimmunize young travelers at 12-15 months and again at 4-6 years. The CDC has developed a toolkit that contains resources for taking to parents about vaccines. It is available at https://www.cdc.gov/measles/toolkit/healthcare-providers.html.

It’s a typically busy Friday and the doctor is running 20 minutes behind schedule. He enters the next exam room and the sight of the patient makes him forget the apology he had prepared.

C5Media/Getty Images

The 10 month old looks miserable. Red eyes. Snot dripping from his nose. A red rash that extends from his face and involves most of the chest, arms, and upper thighs.

“When did this start?” he asks the mother as he searches for a surgical mask in the cabinet next to the exam table.

“Two days after we returned from our vacation in France,” the worried young woman replies. “Do you think it could be measles?”

Between Jan. 1 and Aug. 8, 2019, 1,182 cases of measles had been confirmed in the United States. That’s more than three times the number of cases reported in all of 2018, and the highest number of cases reported in a single year in more than a quarter century. While 75% of the cases this year have been linked to outbreaks in New York, individuals from 30 states have been affected.

Given the widespread nature of the outbreak, it makes sense for every ambulatory office to have a plan for managing exposures to infectious diseases including measles. With measles in particular, time is limited to deliver effective postexposure prophylaxis and prevent the spread of measles in the community, making it difficult to develop a plan on the fly.

Schedule strategically. You don’t want a patient with measles hanging out in your waiting room. According to the American Academy of Pediatrics, measures to prevent the transmission of contagious infectious agents in ambulatory facilities begin at the time the visit is scheduled. When there is measles transmission in the community, consider using a standardized script when scheduling patients that includes questions about fever, rash, other symptoms typical for measles, and possible exposures. Some offices will have procedures in place that can be adapted to care for patients with suspected measles. When a patient presents for suspected chicken pox, do you advise them to come at the end of the day to minimize exposures? Enter through a side door? Perform a car visit?

Triage promptly. Mask patients with fever and rash, move to a private room, and close the door.

Once measles is suspected, only health care personnel who are immune to measles should enter the exam room. According to the Centers for Disease Control and Prevention, presumptive evidence of measles immunity in health care providers is written documentation of vaccination with two doses of live measles or MMR vaccine administered at least 28 days apart, laboratory evidence of immunity (that is, positive measles IgG), laboratory confirmation of disease, or birth before 1957.

Even though health care providers born before 1957 are presumed to have had the disease at some point and have traditionally been considered immune, the CDC suggests that health care facilities consider giving these individuals two doses of MMR vaccine unless they have prior laboratory confirmation of disease immunity. Do you know who in your office is immune or would you need to scramble if you had an exposure?

When measles is suspected, health care personnel should wear an N-95 if they have been fit tested and the appropriate mask is available. Practically, most ambulatory offices do not stock N-95 masks and the next best choice is a regular surgical mask.

Order the recommended tests to confirm the diagnosis, but do not wait for the results to confirm the diagnosis. The CDC recommends testing serum for IgM antibodies and sending a throat or nasopharyngeal swab to look for the virus by polymerase chain reaction testing. Measles virus also is shed in the urine so collecting a urine specimen for testing may increase the chances of finding the virus. Depending on where you practice, the tests may take 3 days or more to result. Contact your local health department as soon as you consider a measles diagnosis.

Discharge patients home or transferred to a higher level of care if this is necessary as quickly as possible. Fortunately, most patients with measles do not require hospitalization. Do not send patients to the hospital simply for the purpose of laboratory testing if this can be accomplished quickly in your office or for evaluation by other providers. This just creates the potential for more exposures. If a patient does require higher-level care, provider-to-provider communication about the suspected diagnosis and the need for airborne isolation should take place.

Keep the door closed. Once a patient with suspected measles is discharged from a regular exam room, the door should remain closed, and it should not be used for at least 1 hour. Remember that infectious virus can remain in the air for 1-2 hours after a patient leaves an area. The same is true for the waiting room.

Develop the exposure list. In general, patients and family members who were in the waiting room at the same time as the index patient and up to 1-2 hours after the index patient left are considered exposed. Measles is highly contagious and 9 out of 10 susceptible people who are exposed will develop disease. How many infants aged less than 1 year might be in your waiting room at any given time? How many immunocompromised patients or family members? Public health authorities can help determine who needs prophylaxis.

Don’t get anxious and start testing everyone for measles, especially patients who lack typical signs and symptoms or exposures. Ordering a test in a patient who has a low likelihood of measles is more likely to result in a false-positive test than a true-positive test. False-positive measles IgM tests can be seen with some viral infections, including parvovirus and Epstein-Barr. Some rheumatologic disorders also can contribute to false-positive tests.

Review your office procedure for vaccine counseling. The 10 month old with measles in the opening vignette should have been given an MMR vaccine before travel. The vaccine is recommended for infants aged 6-11 months who are traveling outside the United States, but it doesn’t count toward the vaccine series. Reimmunize young travelers at 12-15 months and again at 4-6 years. The CDC has developed a toolkit that contains resources for taking to parents about vaccines. It is available at https://www.cdc.gov/measles/toolkit/healthcare-providers.html.

Nebraska’s Department of Education recommended in a guidance that children be allowed to possess and use sunscreen products in school and at school-sponsored events, according to an Aug. 2 release from the American Society for Dermatologic Surgery.

American Society for Dermatologic Surgery Association (ASDSA)

The department’s guidance is based on model legislation developed by the SUNucate Coalition, which was created by the American Society for Dermatologic Surgery Association and “works to address barriers to sunscreen use in school and camps and promote sun-safe behavior.” The coalition was created in 2016 because of reports that some U.S. schools had banned sunscreen products as part of broader medication bans because of these products’ classification as an over-the-counter medication.

Twenty-three other states have moved to lift such bans; these states were joined by Arkansas, Connecticut, Illinois, Maine, Minnesota, Nevada, and now Nebraska in 2019 alone. The District of Columbia, Massachusetts, New Jersey, and Rhode Island are expected to follow suit.

[email protected]

Nebraska’s Department of Education recommended in a guidance that children be allowed to possess and use sunscreen products in school and at school-sponsored events, according to an Aug. 2 release from the American Society for Dermatologic Surgery.

American Society for Dermatologic Surgery Association (ASDSA)

The department’s guidance is based on model legislation developed by the SUNucate Coalition, which was created by the American Society for Dermatologic Surgery Association and “works to address barriers to sunscreen use in school and camps and promote sun-safe behavior.” The coalition was created in 2016 because of reports that some U.S. schools had banned sunscreen products as part of broader medication bans because of these products’ classification as an over-the-counter medication.

Twenty-three other states have moved to lift such bans; these states were joined by Arkansas, Connecticut, Illinois, Maine, Minnesota, Nevada, and now Nebraska in 2019 alone. The District of Columbia, Massachusetts, New Jersey, and Rhode Island are expected to follow suit.

[email protected]

Nebraska’s Department of Education recommended in a guidance that children be allowed to possess and use sunscreen products in school and at school-sponsored events, according to an Aug. 2 release from the American Society for Dermatologic Surgery.

American Society for Dermatologic Surgery Association (ASDSA)

The department’s guidance is based on model legislation developed by the SUNucate Coalition, which was created by the American Society for Dermatologic Surgery Association and “works to address barriers to sunscreen use in school and camps and promote sun-safe behavior.” The coalition was created in 2016 because of reports that some U.S. schools had banned sunscreen products as part of broader medication bans because of these products’ classification as an over-the-counter medication.

Twenty-three other states have moved to lift such bans; these states were joined by Arkansas, Connecticut, Illinois, Maine, Minnesota, Nevada, and now Nebraska in 2019 alone. The District of Columbia, Massachusetts, New Jersey, and Rhode Island are expected to follow suit.

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Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?

A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.

B. The pedestrian can sue Driver D for negligent driving.

C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.

D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.

E. All statements above are correct.
 

Answer: E. A doctor owes a duty of care only to his/her own patients. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.

Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.

The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,¹ pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.² The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.

Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled³ that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.⁴

In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,⁵ a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.

A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,⁶ a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
 

Dr. Tan is professor of medicine and 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. For additional information, readers may contact the author at [email protected].

References

1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.

2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).

3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).

4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).

5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).

Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?

A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.

B. The pedestrian can sue Driver D for negligent driving.

C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.

D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.

E. All statements above are correct.
 

Answer: E. A doctor owes a duty of care only to his/her own patients. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.

Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.

The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,¹ pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.² The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.

Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled³ that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.⁴

In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,⁵ a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.

A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,⁶ a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
 

Dr. Tan is professor of medicine and 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. For additional information, readers may contact the author at [email protected].

References

1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.

2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).

3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).

4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).

5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).

Question: Driver D strikes a pedestrian after losing control of his vehicle from insulin-induced hypoglycemia. Both Driver D and pedestrian were seriously injured. Driver D was recently diagnosed with diabetes, and his physician had started him on insulin, but did not warn of driving risks associated with hypoglycemia. The injured pedestrian is a total stranger to both Driver D and his doctor. Given these facts, which one of the following choices is correct?

A. Driver D can sue his doctor for failure to disclose hypoglycemic risk of insulin therapy under the doctrine of informed consent.

B. The pedestrian can sue Driver D for negligent driving.

C. The pedestrian may succeed in suing Driver D’s doctor for failure to warn of hypoglycemia.

D. The pedestrian’s lawsuit against Driver D’s doctor may fail in a jurisdiction that does not recognize a doctor’s legal duty to an unidentifiable, nonpatient third party.

E. All statements above are correct.
 

Answer: E. A doctor owes a duty of care only to his/her own patients. This legal duty grows out of the doctor-patient relationship, and is normally owed to the patient and to no one else. However, in limited circumstances, it may be extended to other individuals, so-called third parties, who may be total strangers. Injured nonpatient third parties from driving accidents have successfully sued doctors for failing to warn their patients that their medical conditions and/or medications can adversely affect driving ability.

Vizzoni v. Mulford-Dera is a New Jersey malpractice case that is currently before the state’s appellate court. The issue is whether Dr. Lerner, a psychiatrist, can be found negligent for the death of a bicyclist caused by the psychiatrist’s patient, Ms. Mulford-Dera, whose car struck and killed the cyclist. The decedent’s estate alleged that the physician should have warned the patient of the risks of driving while taking psychotropic medications. Dr. Lerner had been treating Ms. Mulford-Dera for psychological conditions, including major depression, panic disorder, and attention deficit disorder. As part of her treatment, Dr. Lerner prescribed several medications, allegedly without disclosing their potential adverse impact on driving. The trial court granted summary judgment and dismissed the case, ruling that the doctor owed no direct or indirect duty to the victim.

The case is currently on appeal. The AMA has filed an amicus brief in support of Dr. Lerner,¹ pointing out that third-party claims had previously been rejected in New Jersey, where the injured victim is not readily identifiable. The brief emphasizes the folly of placing the physician or therapist in the untenable position of serving two potentially competing interests when a physician’s priority should be providing care to the patient. It referenced a similar case in Kansas, where a motorist who had fallen asleep at the wheel struck a bicyclist. The motorist was being treated by a neurologist for a sleep disorder.² The Kansas Supreme Court held that there was no special relationship between the doctor and the cyclist that would impose a duty to warn the motorist about harming a third party.

Other jurisdictions have likewise rejected attempts at “derivative duties” in automobile accident cases. The Connecticut Supreme Court has ruled³ that doctors are immune from third party traffic accident lawsuits, as such litigation would detract from what’s best for the patient (“a physician’s desire to avoid lawsuits may result in far more restrictive advice than necessary for the patient’s well-being”). In that case, the defendant-gastroenterologist, Dr. Troncale, was treating a patient with hepatic encephalopathy and had not warned of the associated risk of driving. And an Illinois court dismissed a third party’s case against a hospital when one of its physicians fell asleep at the wheel after working excessive hours.⁴

In contrast, other jurisdictions have found a legal duty for physicians toward nonpatient victims. For example, in McKenzie v. Hawaii Permanente Medical Group,⁵ a car suddenly veered across five lanes of traffic, striking an 11-year-old girl and crushing her against a cement planter. The driver alleged that the prescription medication, Prazosin, caused him to lose control of the car, and that the treating physician was negligent, first in prescribing an inappropriate type and dose of medication, and second in failing to warn of potential side effects that could affect driving ability. The Hawaii Supreme Court emphasized that the risk of tort liability to an individual physician already discourages negligent prescribing; therefore, a physician does not have a duty to third parties where the alleged negligence involves prescribing decisions, i.e., whether to prescribe medication at all, which medication to prescribe, and what dosage to use. On the other hand, physicians have a duty to their patients to warn of potential adverse effects and this responsibility should therefore extend to third parties. Thus, liability would attach to injuries of innocent third parties as a result of failing to warn of a medication’s effects on driving—unless a reasonable person could be expected to be aware of this risk without the warning.

A foreseeable and unreasonable risk of harm is an important but not the only decisive factor in construing the existence of legal duty. Under some circumstances, the term “special relationship” has been employed based on a consideration of existing social values, customs, and policy considerations. In a Massachusetts case,⁶ a family physician had failed to warn his patient of the risk of diabetes drugs when operating a vehicle. Some 45 minutes after the patient’s discharge from the hospital, he developed hypoglycemia, losing consciousness and injuring a motorcyclist who then sued the doctor. The court invoked the “special relationship” rationale in ruling that the doctor owed a duty to the motorcyclist for public policy reasons.
 

Dr. Tan is professor of medicine and 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. For additional information, readers may contact the author at [email protected].

References

1. Vizzoni v. Mulford-Dera, In the Superior Court of New Jersey Appellate Division, Docket No. A-001255-18T3.

2. Calwell v. Hassan, 925 P.2d 422, 430 (Kan. 1996).

3. Jarmie v. Troncale, 50 A.3d 802 (Conn. 2012).

4. Brewster v. Rush-Presbyterian-St. Luke’s Med. Ctr., 836 N.E.2d 635 (Ill. Ct. App. 2005).

5. McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 (Haw. 2002).

6. Arsenault v. McConarty, 21 Mass. L. Rptr. 500 (2006).

LJUBLJANA, SLOVENIA – A prospective international surveillance study has provided new insights into the surprisingly substantial clinical burden of viral meningitis caused by enteroviruses and human parechoviruses in young infants, Seilesh Kadambari, MBBS, PhD, said in his ESPID Young Investigator Award Lecture at the annual meeting of the European Society for Paediatric Infectious Diseases.

This comprehensive study captured all cases of laboratory-confirmed enterovirus (EV) and human parechovirus (HPeV) meningitis in infants less than 90 days old seen by pediatricians in the United Kingdom and Ireland during a 13-month period starting in July 2014, a time free of outbreaks. Dr. Kadambari, a pediatrician at the University of Oxford (England), was first author of the study. It was for this project, as well as his earlier studies shedding light on congenital viral infections, that he received the Young Investigator honor.

Among the key findings of the U.K./Ireland surveillance study: The incidence of EV/HPeV meningitis was more than twice that of bacterial meningitis in the same age group and more than fivefold higher than that of group B streptococcal meningitis, the No. 1 cause of bacterial meningitis in early infancy. Moreover, more than one-half of infants with EV/HPeV meningitis had low levels of inflammatory markers and no cerebrospinal fluid pleocytosis, which underscores the importance of routinely testing the cerebrospinal fluid for viral causes of meningitis in such patients using modern molecular tools such as multiplex polymerase chain reaction, according to Dr. Kadambari.

“Also, not a single one of the patients with EV/HPeV meningitis had a secondary bacterial infection – and that has important implications for management of our antibiotic stewardship programs,” he observed.

The study (Arch Dis Child. 2019 Jun;104(6):552-7) identified 668 cases of EV meningitis and 35 of HPeV meningitis, for an incidence of 0.79 and 0.04 per 1,000 live births, respectively. The most common clinical presentations were those generally seen in meningitis: fever, irritability, and reduced feeding. Circulatory shock was present in 43% of the infants with HPeV and 27% of the infants with EV infections.

Of infants with EV meningitis, 11% required admission to an intensive care unit, as did 23% of those with HPeV meningitis. Two babies with EV meningitis died and four others had continued neurologic complications at 12 months of follow-up. In contrast, all infants with HPeV survived without long-term sequelae.

Reassuringly, none of the 189 infants who underwent formal hearing testing had sensorineural hearing loss.

The surveillance study data have played an influential role in evidence-based guidelines for EV diagnosis and characterization published by the European Society of Clinical Virology (J Clin Virol. 2018 Apr;101:11-7).

An earlier study led by Dr. Kadambari documented a hefty sevenfold increase in the rate of laboratory-confirmed viral meningo-encephalitis in England and Wales during 2004-2013 across all age groups (J Infect. 2014 Oct;69[4]:326-32).

He attributed this increase to improved diagnosis of viral forms of meningitis through greater use of polymerase chain reaction. The study, based upon National Health Service hospital records, showed that more than 90% of all cases of viral meningo-encephalitis in infants less than 90 days old were caused by EV, a finding that prompted the subsequent prospective U.K./Ireland surveillance study.

Dr. Kadambari closed by noting the past decade had seen a greatly improved ability to diagnose congenital viral infections, but those improvements are not good enough.

“In the decade ahead, we hope to improve the management of this poorly understood group of infections,” the pediatrician promised.

Planned efforts include a cost-effectiveness analysis of a cytomegalovirus vaccine, an ESPID-funded research project aimed at identifying which EV/HPeV strains are most responsible for outbreaks and isolated severe disease, and gaining insight into the host-immunity factors associated with a proclivity to develop EV/HPeV meningitis in early infancy.

Dr. Kadambari reported having no financial conflicts regarding his studies, which was funded largely by Public Health England and university grants.

[email protected]

SOURCE: Kadambari S et al. Arch Dis Child. 2019;104:552-7.

LJUBLJANA, SLOVENIA – A prospective international surveillance study has provided new insights into the surprisingly substantial clinical burden of viral meningitis caused by enteroviruses and human parechoviruses in young infants, Seilesh Kadambari, MBBS, PhD, said in his ESPID Young Investigator Award Lecture at the annual meeting of the European Society for Paediatric Infectious Diseases.

This comprehensive study captured all cases of laboratory-confirmed enterovirus (EV) and human parechovirus (HPeV) meningitis in infants less than 90 days old seen by pediatricians in the United Kingdom and Ireland during a 13-month period starting in July 2014, a time free of outbreaks. Dr. Kadambari, a pediatrician at the University of Oxford (England), was first author of the study. It was for this project, as well as his earlier studies shedding light on congenital viral infections, that he received the Young Investigator honor.

Among the key findings of the U.K./Ireland surveillance study: The incidence of EV/HPeV meningitis was more than twice that of bacterial meningitis in the same age group and more than fivefold higher than that of group B streptococcal meningitis, the No. 1 cause of bacterial meningitis in early infancy. Moreover, more than one-half of infants with EV/HPeV meningitis had low levels of inflammatory markers and no cerebrospinal fluid pleocytosis, which underscores the importance of routinely testing the cerebrospinal fluid for viral causes of meningitis in such patients using modern molecular tools such as multiplex polymerase chain reaction, according to Dr. Kadambari.

“Also, not a single one of the patients with EV/HPeV meningitis had a secondary bacterial infection – and that has important implications for management of our antibiotic stewardship programs,” he observed.

The study (Arch Dis Child. 2019 Jun;104(6):552-7) identified 668 cases of EV meningitis and 35 of HPeV meningitis, for an incidence of 0.79 and 0.04 per 1,000 live births, respectively. The most common clinical presentations were those generally seen in meningitis: fever, irritability, and reduced feeding. Circulatory shock was present in 43% of the infants with HPeV and 27% of the infants with EV infections.

Of infants with EV meningitis, 11% required admission to an intensive care unit, as did 23% of those with HPeV meningitis. Two babies with EV meningitis died and four others had continued neurologic complications at 12 months of follow-up. In contrast, all infants with HPeV survived without long-term sequelae.

Reassuringly, none of the 189 infants who underwent formal hearing testing had sensorineural hearing loss.

The surveillance study data have played an influential role in evidence-based guidelines for EV diagnosis and characterization published by the European Society of Clinical Virology (J Clin Virol. 2018 Apr;101:11-7).

An earlier study led by Dr. Kadambari documented a hefty sevenfold increase in the rate of laboratory-confirmed viral meningo-encephalitis in England and Wales during 2004-2013 across all age groups (J Infect. 2014 Oct;69[4]:326-32).

He attributed this increase to improved diagnosis of viral forms of meningitis through greater use of polymerase chain reaction. The study, based upon National Health Service hospital records, showed that more than 90% of all cases of viral meningo-encephalitis in infants less than 90 days old were caused by EV, a finding that prompted the subsequent prospective U.K./Ireland surveillance study.

Dr. Kadambari closed by noting the past decade had seen a greatly improved ability to diagnose congenital viral infections, but those improvements are not good enough.

“In the decade ahead, we hope to improve the management of this poorly understood group of infections,” the pediatrician promised.

Planned efforts include a cost-effectiveness analysis of a cytomegalovirus vaccine, an ESPID-funded research project aimed at identifying which EV/HPeV strains are most responsible for outbreaks and isolated severe disease, and gaining insight into the host-immunity factors associated with a proclivity to develop EV/HPeV meningitis in early infancy.

Dr. Kadambari reported having no financial conflicts regarding his studies, which was funded largely by Public Health England and university grants.

[email protected]

SOURCE: Kadambari S et al. Arch Dis Child. 2019;104:552-7.

LJUBLJANA, SLOVENIA – A prospective international surveillance study has provided new insights into the surprisingly substantial clinical burden of viral meningitis caused by enteroviruses and human parechoviruses in young infants, Seilesh Kadambari, MBBS, PhD, said in his ESPID Young Investigator Award Lecture at the annual meeting of the European Society for Paediatric Infectious Diseases.

This comprehensive study captured all cases of laboratory-confirmed enterovirus (EV) and human parechovirus (HPeV) meningitis in infants less than 90 days old seen by pediatricians in the United Kingdom and Ireland during a 13-month period starting in July 2014, a time free of outbreaks. Dr. Kadambari, a pediatrician at the University of Oxford (England), was first author of the study. It was for this project, as well as his earlier studies shedding light on congenital viral infections, that he received the Young Investigator honor.

Among the key findings of the U.K./Ireland surveillance study: The incidence of EV/HPeV meningitis was more than twice that of bacterial meningitis in the same age group and more than fivefold higher than that of group B streptococcal meningitis, the No. 1 cause of bacterial meningitis in early infancy. Moreover, more than one-half of infants with EV/HPeV meningitis had low levels of inflammatory markers and no cerebrospinal fluid pleocytosis, which underscores the importance of routinely testing the cerebrospinal fluid for viral causes of meningitis in such patients using modern molecular tools such as multiplex polymerase chain reaction, according to Dr. Kadambari.

“Also, not a single one of the patients with EV/HPeV meningitis had a secondary bacterial infection – and that has important implications for management of our antibiotic stewardship programs,” he observed.

The study (Arch Dis Child. 2019 Jun;104(6):552-7) identified 668 cases of EV meningitis and 35 of HPeV meningitis, for an incidence of 0.79 and 0.04 per 1,000 live births, respectively. The most common clinical presentations were those generally seen in meningitis: fever, irritability, and reduced feeding. Circulatory shock was present in 43% of the infants with HPeV and 27% of the infants with EV infections.

Of infants with EV meningitis, 11% required admission to an intensive care unit, as did 23% of those with HPeV meningitis. Two babies with EV meningitis died and four others had continued neurologic complications at 12 months of follow-up. In contrast, all infants with HPeV survived without long-term sequelae.

Reassuringly, none of the 189 infants who underwent formal hearing testing had sensorineural hearing loss.

The surveillance study data have played an influential role in evidence-based guidelines for EV diagnosis and characterization published by the European Society of Clinical Virology (J Clin Virol. 2018 Apr;101:11-7).

An earlier study led by Dr. Kadambari documented a hefty sevenfold increase in the rate of laboratory-confirmed viral meningo-encephalitis in England and Wales during 2004-2013 across all age groups (J Infect. 2014 Oct;69[4]:326-32).

He attributed this increase to improved diagnosis of viral forms of meningitis through greater use of polymerase chain reaction. The study, based upon National Health Service hospital records, showed that more than 90% of all cases of viral meningo-encephalitis in infants less than 90 days old were caused by EV, a finding that prompted the subsequent prospective U.K./Ireland surveillance study.

Dr. Kadambari closed by noting the past decade had seen a greatly improved ability to diagnose congenital viral infections, but those improvements are not good enough.

“In the decade ahead, we hope to improve the management of this poorly understood group of infections,” the pediatrician promised.

Planned efforts include a cost-effectiveness analysis of a cytomegalovirus vaccine, an ESPID-funded research project aimed at identifying which EV/HPeV strains are most responsible for outbreaks and isolated severe disease, and gaining insight into the host-immunity factors associated with a proclivity to develop EV/HPeV meningitis in early infancy.

Dr. Kadambari reported having no financial conflicts regarding his studies, which was funded largely by Public Health England and university grants.

[email protected]

SOURCE: Kadambari S et al. Arch Dis Child. 2019;104:552-7.