User login
FDA issues new REMS for immediate-release opioids
Opioid prescribers will need to be mindful of a new, expanded Risk Evaluation and Mitigation Strategy issued Sept. 18 by the Food and Drug Administration, covering immediate-release opioid analgesics used in the outpatient setting. The strategy also applies to extended-release and long-acting opioids, which have been subject to REMS since 2012.
The new REMS program requires for the first time that training be made available to health care providers who are involved in pain management. For the purposes of this REMS program, the training is not limited to just the prescriber, but includes nurses and pharmacists.
, including alternatives to opioids for pain management.
The FDA said it is in the process of approving a new label for opioids that will contain information about health care provider education that is now a part of the REMS.
“Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Appropriate prescribing practices and education are important steps that we are prioritizing to help address the human and financial toll of this crisis.”
Dr. Gottlieb added that the goal of the new REMS is to help prescribers with the latest evidence on the appropriate amount of doses that should be prescribed for a given condition and that the “aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”
The FDA also approved a new guidance document that includes updated educational content.
Opioid prescribers will need to be mindful of a new, expanded Risk Evaluation and Mitigation Strategy issued Sept. 18 by the Food and Drug Administration, covering immediate-release opioid analgesics used in the outpatient setting. The strategy also applies to extended-release and long-acting opioids, which have been subject to REMS since 2012.
The new REMS program requires for the first time that training be made available to health care providers who are involved in pain management. For the purposes of this REMS program, the training is not limited to just the prescriber, but includes nurses and pharmacists.
, including alternatives to opioids for pain management.
The FDA said it is in the process of approving a new label for opioids that will contain information about health care provider education that is now a part of the REMS.
“Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Appropriate prescribing practices and education are important steps that we are prioritizing to help address the human and financial toll of this crisis.”
Dr. Gottlieb added that the goal of the new REMS is to help prescribers with the latest evidence on the appropriate amount of doses that should be prescribed for a given condition and that the “aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”
The FDA also approved a new guidance document that includes updated educational content.
Opioid prescribers will need to be mindful of a new, expanded Risk Evaluation and Mitigation Strategy issued Sept. 18 by the Food and Drug Administration, covering immediate-release opioid analgesics used in the outpatient setting. The strategy also applies to extended-release and long-acting opioids, which have been subject to REMS since 2012.
The new REMS program requires for the first time that training be made available to health care providers who are involved in pain management. For the purposes of this REMS program, the training is not limited to just the prescriber, but includes nurses and pharmacists.
, including alternatives to opioids for pain management.
The FDA said it is in the process of approving a new label for opioids that will contain information about health care provider education that is now a part of the REMS.
“Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Appropriate prescribing practices and education are important steps that we are prioritizing to help address the human and financial toll of this crisis.”
Dr. Gottlieb added that the goal of the new REMS is to help prescribers with the latest evidence on the appropriate amount of doses that should be prescribed for a given condition and that the “aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines.”
The FDA also approved a new guidance document that includes updated educational content.
Expert panel updates guidelines on antithrombotic therapy for AF
For patients with , experts said in a comprehensive, updated guideline.
The 113-page guideline, published in the journal CHEST®, provides antithrombotic treatment recommendations for atrial fibrillation based on different levels of risk for stroke and in a variety of clinical presentations.
Altogether, the new guidelines highlight 60 key recommendations from the 12-person expert panel, chaired by Gregory Y.H. Lip, MD, of the Institute of Cardiovascular Sciences, University of Birmingham (England).
To develop the guidelines, the panel conducted a systematic literature review of relevant articles released since the 2012 publication of Thrombolytic Therapy: American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines (9th Edition).
Since that time, “there have been substantial developments in atrial fibrillation thromboprophylaxis, whether with regard to risk assessment, antithrombotic drugs, or non-drug approaches,” panelists said in their report.
The panel graded the quality of the new evidence found in the literature review, and then undertook a consensus development process. Each recommendation and statement required at least 80% consensus to pass.
Their treatment recommendations in the report are focused on three topic areas: stroke and bleeding risk assessment, antithrombotic therapy in general, and antithrombotic therapy in special situations, such as acute coronary syndrome and stenting, chronic atrial flutter, pregnancy, and chronic kidney disease.
Stroke prevention is the main priority in a “holistic approach” to management of atrial fibrillation, the panelists said in the report.
“Many of the risk factors leading to incident AF are also risk factors for ischemic stroke, and the promotion of an integrated or holistic approach to AF management is needed, incorporating stroke prevention, addressing symptoms and risk factor management,” they said.
No antithrombotic therapy is needed for patients who have atrial fibrillation without valvular heart disease, the panelists concluded.
For patients with at least one nongender CHA2DS2-VASc stroke risk factor, oral anticoagulation is recommended over aspirin, aspirin and clopidogrel, or no therapy, they said.
In high-risk patients, including males with two or more CHA2DS2-VASc risk factors and females with three or more, novel oral anticoagulants are recommended over adjusted-dose warfarin, they added.
At each patient contact, patients with atrial fibrillation should receive bleeding risk assessment starting with potentially modifiable risk factors such as uncontrolled blood pressure or excessive alcohol intake, according to the expert panel.
High-risk patients, as indicated by a HAS-BLED score of 3 or greater, should have more frequent and regular follow-up, they said.
The expert panel report concludes with a discussion on practical and patient-centered issues.
“Patient education is essential to provide patients with sufficient information to enable them to make an informed decision about whether or not they wish to take oral anticoagulants, and if they do, which oral anticoagulant they would prefer,” Dr. Lip and his colleagues said in their report.
Dr. Lip disclosed a potential conflict of interest with Boehringer Ingelheim. Expert panel members reported disclosures related to Boston Scientific, Medtronic, St. Jude Medical, Biotronik, MSD, Novartis, Pfizer, Bayer, Servier, Gilead, Bristol-Myers Squibb, AstraZeneca, and others.
SOURCE: Lip GYH et al. CHEST. 2018 Aug 21. pii: S0012-3692(18)32244-X.
For patients with , experts said in a comprehensive, updated guideline.
The 113-page guideline, published in the journal CHEST®, provides antithrombotic treatment recommendations for atrial fibrillation based on different levels of risk for stroke and in a variety of clinical presentations.
Altogether, the new guidelines highlight 60 key recommendations from the 12-person expert panel, chaired by Gregory Y.H. Lip, MD, of the Institute of Cardiovascular Sciences, University of Birmingham (England).
To develop the guidelines, the panel conducted a systematic literature review of relevant articles released since the 2012 publication of Thrombolytic Therapy: American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines (9th Edition).
Since that time, “there have been substantial developments in atrial fibrillation thromboprophylaxis, whether with regard to risk assessment, antithrombotic drugs, or non-drug approaches,” panelists said in their report.
The panel graded the quality of the new evidence found in the literature review, and then undertook a consensus development process. Each recommendation and statement required at least 80% consensus to pass.
Their treatment recommendations in the report are focused on three topic areas: stroke and bleeding risk assessment, antithrombotic therapy in general, and antithrombotic therapy in special situations, such as acute coronary syndrome and stenting, chronic atrial flutter, pregnancy, and chronic kidney disease.
Stroke prevention is the main priority in a “holistic approach” to management of atrial fibrillation, the panelists said in the report.
“Many of the risk factors leading to incident AF are also risk factors for ischemic stroke, and the promotion of an integrated or holistic approach to AF management is needed, incorporating stroke prevention, addressing symptoms and risk factor management,” they said.
No antithrombotic therapy is needed for patients who have atrial fibrillation without valvular heart disease, the panelists concluded.
For patients with at least one nongender CHA2DS2-VASc stroke risk factor, oral anticoagulation is recommended over aspirin, aspirin and clopidogrel, or no therapy, they said.
In high-risk patients, including males with two or more CHA2DS2-VASc risk factors and females with three or more, novel oral anticoagulants are recommended over adjusted-dose warfarin, they added.
At each patient contact, patients with atrial fibrillation should receive bleeding risk assessment starting with potentially modifiable risk factors such as uncontrolled blood pressure or excessive alcohol intake, according to the expert panel.
High-risk patients, as indicated by a HAS-BLED score of 3 or greater, should have more frequent and regular follow-up, they said.
The expert panel report concludes with a discussion on practical and patient-centered issues.
“Patient education is essential to provide patients with sufficient information to enable them to make an informed decision about whether or not they wish to take oral anticoagulants, and if they do, which oral anticoagulant they would prefer,” Dr. Lip and his colleagues said in their report.
Dr. Lip disclosed a potential conflict of interest with Boehringer Ingelheim. Expert panel members reported disclosures related to Boston Scientific, Medtronic, St. Jude Medical, Biotronik, MSD, Novartis, Pfizer, Bayer, Servier, Gilead, Bristol-Myers Squibb, AstraZeneca, and others.
SOURCE: Lip GYH et al. CHEST. 2018 Aug 21. pii: S0012-3692(18)32244-X.
For patients with , experts said in a comprehensive, updated guideline.
The 113-page guideline, published in the journal CHEST®, provides antithrombotic treatment recommendations for atrial fibrillation based on different levels of risk for stroke and in a variety of clinical presentations.
Altogether, the new guidelines highlight 60 key recommendations from the 12-person expert panel, chaired by Gregory Y.H. Lip, MD, of the Institute of Cardiovascular Sciences, University of Birmingham (England).
To develop the guidelines, the panel conducted a systematic literature review of relevant articles released since the 2012 publication of Thrombolytic Therapy: American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines (9th Edition).
Since that time, “there have been substantial developments in atrial fibrillation thromboprophylaxis, whether with regard to risk assessment, antithrombotic drugs, or non-drug approaches,” panelists said in their report.
The panel graded the quality of the new evidence found in the literature review, and then undertook a consensus development process. Each recommendation and statement required at least 80% consensus to pass.
Their treatment recommendations in the report are focused on three topic areas: stroke and bleeding risk assessment, antithrombotic therapy in general, and antithrombotic therapy in special situations, such as acute coronary syndrome and stenting, chronic atrial flutter, pregnancy, and chronic kidney disease.
Stroke prevention is the main priority in a “holistic approach” to management of atrial fibrillation, the panelists said in the report.
“Many of the risk factors leading to incident AF are also risk factors for ischemic stroke, and the promotion of an integrated or holistic approach to AF management is needed, incorporating stroke prevention, addressing symptoms and risk factor management,” they said.
No antithrombotic therapy is needed for patients who have atrial fibrillation without valvular heart disease, the panelists concluded.
For patients with at least one nongender CHA2DS2-VASc stroke risk factor, oral anticoagulation is recommended over aspirin, aspirin and clopidogrel, or no therapy, they said.
In high-risk patients, including males with two or more CHA2DS2-VASc risk factors and females with three or more, novel oral anticoagulants are recommended over adjusted-dose warfarin, they added.
At each patient contact, patients with atrial fibrillation should receive bleeding risk assessment starting with potentially modifiable risk factors such as uncontrolled blood pressure or excessive alcohol intake, according to the expert panel.
High-risk patients, as indicated by a HAS-BLED score of 3 or greater, should have more frequent and regular follow-up, they said.
The expert panel report concludes with a discussion on practical and patient-centered issues.
“Patient education is essential to provide patients with sufficient information to enable them to make an informed decision about whether or not they wish to take oral anticoagulants, and if they do, which oral anticoagulant they would prefer,” Dr. Lip and his colleagues said in their report.
Dr. Lip disclosed a potential conflict of interest with Boehringer Ingelheim. Expert panel members reported disclosures related to Boston Scientific, Medtronic, St. Jude Medical, Biotronik, MSD, Novartis, Pfizer, Bayer, Servier, Gilead, Bristol-Myers Squibb, AstraZeneca, and others.
SOURCE: Lip GYH et al. CHEST. 2018 Aug 21. pii: S0012-3692(18)32244-X.
FROM CHEST
Azithromycin for COPD exacerbations may reduce treatment failure
PARIS – In patients with a chronic obstructive pulmonary disease (provided improvement in a variety of outcomes at 90 days, including risk of death, according to a placebo-controlled trial presented as a late-breaker at the annual congress of the European Respiratory Society.
In patients with COPD, “azithromycin initiated in the acute setting and continued for 3 months appears to be safe and potentially effective,” reported Wim Janssens, MD, PhD, division of respiratory medicine, University Hospital, Leuven, Belgium.
The phrase “potentially effective” was used because the primary endpoint, which was time to treatment failure, fell just short of statistical significance (P = .053), but the rate of treatment failures, which was a coprimary endpoint (P = .04), and all of the secondary endpoints, including mortality at 90 days (P = .027), need for treatment intensification (P = .02) and need for an intensive care unit (ICU) admission (P = .003), were significantly lower in the group receiving azithromycin rather than placebo.
In a previous trial, chronic azithromycin therapy on top of usual care in patients frequently hospitalized for COPD was associated with a reduction in the risk of exacerbations and an improvement in quality of life (N Engl J Med. 2011;365:689-98). However, Dr. Janssens explained that this strategy is not commonly used because it was associated with a variety of adverse events, not least of which was QTc prolongation.
The study at the meeting, called the BACE trial, was designed to test whether azithromycin could be employed in a more targeted approach to control exacerbations. In the study, 301 COPD patients hospitalized with an acute exacerbation were randomized within 48 hours of admission to azithromycin or placebo. For the first 3 days, azithromycin was administered in a 500-mg dose. Thereafter, the dose was 250 mg every second day. Treatment was stopped at 90 days.
The primary outcome was time to treatment failure, a novel composite endpoint of any of three events: the need for treatment intensification, the need for step-up hospital care (either ICU admission or hospital readmission), or death by any cause. The two treatment arms were also compared for safety, including QTc prolongation.
The treatment failure rates were 49% in the azithromycin arm and 60% in the placebo arm, producing a hazard ratio (HR) of 0.73. Although this outcome fell short of significance, Dr. Janssens suggested that benefits over the 90 days of treatment are supported by the secondary outcomes. However, he also cautioned that most relative advantages for azithromycin over placebo were found to dissipate over time.
“The maximum separation between the azithromycin and placebo arms [for the primary outcome] occurred at 120 days or 30 days after the medication was stopped,” Dr. Janssens reported. After this point, the two arms converged and eventually overlapped.
However, the acute benefits appeared to be substantial. For example, average hospital stay over the 90-day treatment period was reduced from 40 to 10 days (P = .0061), and the ICU days fell from 11 days to 3 days in the azithromycin relative to the placebo group. According to Dr. Janssens, the difference in hospital stay carries “important health economic potential that deserves further attention.”
Of the three QTc events that occurred during the course of the study, one was observed in the placebo group. There was no significant difference in this or other adverse events, according to Dr. Janssens.
It is notable that the design for the BACE trial called for 500 patients. When enrollment was slow, the design was changed on the basis of power calculations indicating that 300 patients would be sufficient to demonstrate a difference. It is unclear whether a larger study would have permitted the difference in the primary endpoint to advance from a trend.
Dr. Janssens reports no conflicts of interest relevant to this study.
PARIS – In patients with a chronic obstructive pulmonary disease (provided improvement in a variety of outcomes at 90 days, including risk of death, according to a placebo-controlled trial presented as a late-breaker at the annual congress of the European Respiratory Society.
In patients with COPD, “azithromycin initiated in the acute setting and continued for 3 months appears to be safe and potentially effective,” reported Wim Janssens, MD, PhD, division of respiratory medicine, University Hospital, Leuven, Belgium.
The phrase “potentially effective” was used because the primary endpoint, which was time to treatment failure, fell just short of statistical significance (P = .053), but the rate of treatment failures, which was a coprimary endpoint (P = .04), and all of the secondary endpoints, including mortality at 90 days (P = .027), need for treatment intensification (P = .02) and need for an intensive care unit (ICU) admission (P = .003), were significantly lower in the group receiving azithromycin rather than placebo.
In a previous trial, chronic azithromycin therapy on top of usual care in patients frequently hospitalized for COPD was associated with a reduction in the risk of exacerbations and an improvement in quality of life (N Engl J Med. 2011;365:689-98). However, Dr. Janssens explained that this strategy is not commonly used because it was associated with a variety of adverse events, not least of which was QTc prolongation.
The study at the meeting, called the BACE trial, was designed to test whether azithromycin could be employed in a more targeted approach to control exacerbations. In the study, 301 COPD patients hospitalized with an acute exacerbation were randomized within 48 hours of admission to azithromycin or placebo. For the first 3 days, azithromycin was administered in a 500-mg dose. Thereafter, the dose was 250 mg every second day. Treatment was stopped at 90 days.
The primary outcome was time to treatment failure, a novel composite endpoint of any of three events: the need for treatment intensification, the need for step-up hospital care (either ICU admission or hospital readmission), or death by any cause. The two treatment arms were also compared for safety, including QTc prolongation.
The treatment failure rates were 49% in the azithromycin arm and 60% in the placebo arm, producing a hazard ratio (HR) of 0.73. Although this outcome fell short of significance, Dr. Janssens suggested that benefits over the 90 days of treatment are supported by the secondary outcomes. However, he also cautioned that most relative advantages for azithromycin over placebo were found to dissipate over time.
“The maximum separation between the azithromycin and placebo arms [for the primary outcome] occurred at 120 days or 30 days after the medication was stopped,” Dr. Janssens reported. After this point, the two arms converged and eventually overlapped.
However, the acute benefits appeared to be substantial. For example, average hospital stay over the 90-day treatment period was reduced from 40 to 10 days (P = .0061), and the ICU days fell from 11 days to 3 days in the azithromycin relative to the placebo group. According to Dr. Janssens, the difference in hospital stay carries “important health economic potential that deserves further attention.”
Of the three QTc events that occurred during the course of the study, one was observed in the placebo group. There was no significant difference in this or other adverse events, according to Dr. Janssens.
It is notable that the design for the BACE trial called for 500 patients. When enrollment was slow, the design was changed on the basis of power calculations indicating that 300 patients would be sufficient to demonstrate a difference. It is unclear whether a larger study would have permitted the difference in the primary endpoint to advance from a trend.
Dr. Janssens reports no conflicts of interest relevant to this study.
PARIS – In patients with a chronic obstructive pulmonary disease (provided improvement in a variety of outcomes at 90 days, including risk of death, according to a placebo-controlled trial presented as a late-breaker at the annual congress of the European Respiratory Society.
In patients with COPD, “azithromycin initiated in the acute setting and continued for 3 months appears to be safe and potentially effective,” reported Wim Janssens, MD, PhD, division of respiratory medicine, University Hospital, Leuven, Belgium.
The phrase “potentially effective” was used because the primary endpoint, which was time to treatment failure, fell just short of statistical significance (P = .053), but the rate of treatment failures, which was a coprimary endpoint (P = .04), and all of the secondary endpoints, including mortality at 90 days (P = .027), need for treatment intensification (P = .02) and need for an intensive care unit (ICU) admission (P = .003), were significantly lower in the group receiving azithromycin rather than placebo.
In a previous trial, chronic azithromycin therapy on top of usual care in patients frequently hospitalized for COPD was associated with a reduction in the risk of exacerbations and an improvement in quality of life (N Engl J Med. 2011;365:689-98). However, Dr. Janssens explained that this strategy is not commonly used because it was associated with a variety of adverse events, not least of which was QTc prolongation.
The study at the meeting, called the BACE trial, was designed to test whether azithromycin could be employed in a more targeted approach to control exacerbations. In the study, 301 COPD patients hospitalized with an acute exacerbation were randomized within 48 hours of admission to azithromycin or placebo. For the first 3 days, azithromycin was administered in a 500-mg dose. Thereafter, the dose was 250 mg every second day. Treatment was stopped at 90 days.
The primary outcome was time to treatment failure, a novel composite endpoint of any of three events: the need for treatment intensification, the need for step-up hospital care (either ICU admission or hospital readmission), or death by any cause. The two treatment arms were also compared for safety, including QTc prolongation.
The treatment failure rates were 49% in the azithromycin arm and 60% in the placebo arm, producing a hazard ratio (HR) of 0.73. Although this outcome fell short of significance, Dr. Janssens suggested that benefits over the 90 days of treatment are supported by the secondary outcomes. However, he also cautioned that most relative advantages for azithromycin over placebo were found to dissipate over time.
“The maximum separation between the azithromycin and placebo arms [for the primary outcome] occurred at 120 days or 30 days after the medication was stopped,” Dr. Janssens reported. After this point, the two arms converged and eventually overlapped.
However, the acute benefits appeared to be substantial. For example, average hospital stay over the 90-day treatment period was reduced from 40 to 10 days (P = .0061), and the ICU days fell from 11 days to 3 days in the azithromycin relative to the placebo group. According to Dr. Janssens, the difference in hospital stay carries “important health economic potential that deserves further attention.”
Of the three QTc events that occurred during the course of the study, one was observed in the placebo group. There was no significant difference in this or other adverse events, according to Dr. Janssens.
It is notable that the design for the BACE trial called for 500 patients. When enrollment was slow, the design was changed on the basis of power calculations indicating that 300 patients would be sufficient to demonstrate a difference. It is unclear whether a larger study would have permitted the difference in the primary endpoint to advance from a trend.
Dr. Janssens reports no conflicts of interest relevant to this study.
REPORTING FROM THE ERS CONGRESS 2018
Key clinical point: Initiating azithromycin in patients with COPD exacerbation at the time of hospitalization improves short-term outcomes.
Major finding: Relative to placebo, azithromycin provided a borderline reduction in treatment failure (P = .053) while reducing mortality (P = .027).
Study details: Multicenter, placebo-controlled trial.
Disclosures: Dr. Janssens reports no conflicts of interest relevant to this study.
AAP guidelines emphasize gender-affirmative care
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
FROM PEDATRICS
Risk factors for postop cardiac events differ between vascular and general surgery
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
FROM ANNALS OF MEDICINE AND SURGERY
Key clinical point: There was a significant difference in predictive risk factors for postoperative cardiac events between vascular and general surgery.
Major finding: The 1.9% incidence of cardiac events following general or vascular surgery was associated with a mortality rate of 55%.
Study details: Retrospective study of 8,441 patients who underwent vascular or general surgery during 2013-2015.
Disclosures: The authors reported having no disclosures.
Source: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
FDA attacks antibiotic resistance with new strategy
WASHINGTON – A strategy combining stewardship and science is needed to help combat antimicrobial resistance, and updated plans from the U.S. Food and Drug Administration include four key components to address all aspects of product development and use, FDA commissioner Scott Gottlieb, MD, said in a press briefing in Washington on Sept. 14.
“The FDA plays a unique role in advancing human and animal health” that provides a unique vantage point for coordinating all aspects of product development and application, he said.
The FDA’s comprehensive approach to the challenge of antimicrobial resistance (AMR) includes:
- Facilitating product development.
- Promoting antimicrobial stewardship.
- Supporting the development of new tools for surveillance.
- Advancing scientific initiatives, including research for the development of alternative treatments.
The FDA’s product development plan to combat AMR includes the creation of incentives for companies to develop new antibiotic products and create a robust pipeline, which is a challenge because of the lack of immediate economic gain, Dr. Gottlieb said.
“It necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains,” he emphasized.
Strategies to incentivize companies include fast track designation, priority review, and breakthrough therapy designation. In addition, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) is designed to promote development of antimicrobial drugs for limited and underserved populations, Dr. Gottlieb said. The FDA plan also calls for pursuing reimbursement options with the Centers for Medicare & Medicaid Services.
Promoting antimicrobial stewardship remains an ongoing element of the FDA’s plan to reduce AMR. In conjunction with the release of the FDA’s updated approach to AMR, the FDA’s Center for Veterinary Medicine CVM released a 5-year action plan to promote and support antimicrobial stewardship in not only the agricultural arena, but in companion animals as well.
The FDA plans to bring all antimicrobials of medical importance that are approved for use in animals under the oversight of CVM, which will pursue the improve labeling on antimicrobial drugs used in the feed and water of food-producing animals, including defining durations of use, Dr. Gottlieb noted.
Supporting the development and improvement of surveillance tools is “essential to understanding the drivers of resistance in human and veterinary settings and formulating appropriate responses” to outbreaks, Dr. Gottlieb said.
To help meet this goal, the FDA will expand sampling via the National Antimicrobial Resistance Monitoring System (NARMS) database, he said. Other surveillance goals include supporting genomics research and expanding AMR monitoring to include pathogens associated with animal feed and companion animals, he added.
As part of the final component of the FDA’s AMR strategy to advance scientific initiatives, the FDA has released a new Request for Information “to obtain additional, external input on how best to develop an annual list of regulatory science initiatives specific for antimicrobial products,” Dr. Gottlieb announced. The FDA intends to use the information gained from clinicians and others in its creation of guidance documents and recommendations to streamline the antibiotic development process. He also cited the FDA’s ongoing support of partnerships with public and private organizations such as the Clinical Trials Transformation Initiative, which focuses on drug development for severe bacterial infections with current unmet medical need.
“We need to harness science and policy to help our public health systems and researchers become nimbler in the battle against drug-resistant pathogens,” Dr. Gottlieb concluded.
In a panel discussion following the briefing, several experts offered perspective on the FDA’s goals and on the challenges of AMR.
William Flynn, DVM, deputy director of science policy for the Center of Veterinary Medicine, noted some goals for reducing the use of antibiotics in the veterinary arena.
“We are trying to focus on the driver: What are the disease conditions that drive use of the product,” he said. Ideally, better management of disease conditions can reduce reliance on antibiotics, he added.
Also in the panel discussion, Steven Gitterman, MD, deputy director of the division of microbiology devices at the Center for Devices and Radiological Health, emphasized the value of sustainable trial databases so AMR research can continue on an ongoing basis. Finally, Carolyn Wilson, PhD, associate director of research at the Center for Biologics Evaluation and Research, noted that the FDA’s research and development efforts include antibiotic alternatives, including live biotherapeutic products, fecal microbiota transplantation, and bacteriophage therapy.
Visit www.fda.gov for a transcript of Dr. Gottlieb’s talk, and for the updated FDA website page with more details on the agency’s plans to combat antimicrobial resistance.
Dr. Gottlieb and the panelists had no financial conflicts to disclose.
WASHINGTON – A strategy combining stewardship and science is needed to help combat antimicrobial resistance, and updated plans from the U.S. Food and Drug Administration include four key components to address all aspects of product development and use, FDA commissioner Scott Gottlieb, MD, said in a press briefing in Washington on Sept. 14.
“The FDA plays a unique role in advancing human and animal health” that provides a unique vantage point for coordinating all aspects of product development and application, he said.
The FDA’s comprehensive approach to the challenge of antimicrobial resistance (AMR) includes:
- Facilitating product development.
- Promoting antimicrobial stewardship.
- Supporting the development of new tools for surveillance.
- Advancing scientific initiatives, including research for the development of alternative treatments.
The FDA’s product development plan to combat AMR includes the creation of incentives for companies to develop new antibiotic products and create a robust pipeline, which is a challenge because of the lack of immediate economic gain, Dr. Gottlieb said.
“It necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains,” he emphasized.
Strategies to incentivize companies include fast track designation, priority review, and breakthrough therapy designation. In addition, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) is designed to promote development of antimicrobial drugs for limited and underserved populations, Dr. Gottlieb said. The FDA plan also calls for pursuing reimbursement options with the Centers for Medicare & Medicaid Services.
Promoting antimicrobial stewardship remains an ongoing element of the FDA’s plan to reduce AMR. In conjunction with the release of the FDA’s updated approach to AMR, the FDA’s Center for Veterinary Medicine CVM released a 5-year action plan to promote and support antimicrobial stewardship in not only the agricultural arena, but in companion animals as well.
The FDA plans to bring all antimicrobials of medical importance that are approved for use in animals under the oversight of CVM, which will pursue the improve labeling on antimicrobial drugs used in the feed and water of food-producing animals, including defining durations of use, Dr. Gottlieb noted.
Supporting the development and improvement of surveillance tools is “essential to understanding the drivers of resistance in human and veterinary settings and formulating appropriate responses” to outbreaks, Dr. Gottlieb said.
To help meet this goal, the FDA will expand sampling via the National Antimicrobial Resistance Monitoring System (NARMS) database, he said. Other surveillance goals include supporting genomics research and expanding AMR monitoring to include pathogens associated with animal feed and companion animals, he added.
As part of the final component of the FDA’s AMR strategy to advance scientific initiatives, the FDA has released a new Request for Information “to obtain additional, external input on how best to develop an annual list of regulatory science initiatives specific for antimicrobial products,” Dr. Gottlieb announced. The FDA intends to use the information gained from clinicians and others in its creation of guidance documents and recommendations to streamline the antibiotic development process. He also cited the FDA’s ongoing support of partnerships with public and private organizations such as the Clinical Trials Transformation Initiative, which focuses on drug development for severe bacterial infections with current unmet medical need.
“We need to harness science and policy to help our public health systems and researchers become nimbler in the battle against drug-resistant pathogens,” Dr. Gottlieb concluded.
In a panel discussion following the briefing, several experts offered perspective on the FDA’s goals and on the challenges of AMR.
William Flynn, DVM, deputy director of science policy for the Center of Veterinary Medicine, noted some goals for reducing the use of antibiotics in the veterinary arena.
“We are trying to focus on the driver: What are the disease conditions that drive use of the product,” he said. Ideally, better management of disease conditions can reduce reliance on antibiotics, he added.
Also in the panel discussion, Steven Gitterman, MD, deputy director of the division of microbiology devices at the Center for Devices and Radiological Health, emphasized the value of sustainable trial databases so AMR research can continue on an ongoing basis. Finally, Carolyn Wilson, PhD, associate director of research at the Center for Biologics Evaluation and Research, noted that the FDA’s research and development efforts include antibiotic alternatives, including live biotherapeutic products, fecal microbiota transplantation, and bacteriophage therapy.
Visit www.fda.gov for a transcript of Dr. Gottlieb’s talk, and for the updated FDA website page with more details on the agency’s plans to combat antimicrobial resistance.
Dr. Gottlieb and the panelists had no financial conflicts to disclose.
WASHINGTON – A strategy combining stewardship and science is needed to help combat antimicrobial resistance, and updated plans from the U.S. Food and Drug Administration include four key components to address all aspects of product development and use, FDA commissioner Scott Gottlieb, MD, said in a press briefing in Washington on Sept. 14.
“The FDA plays a unique role in advancing human and animal health” that provides a unique vantage point for coordinating all aspects of product development and application, he said.
The FDA’s comprehensive approach to the challenge of antimicrobial resistance (AMR) includes:
- Facilitating product development.
- Promoting antimicrobial stewardship.
- Supporting the development of new tools for surveillance.
- Advancing scientific initiatives, including research for the development of alternative treatments.
The FDA’s product development plan to combat AMR includes the creation of incentives for companies to develop new antibiotic products and create a robust pipeline, which is a challenge because of the lack of immediate economic gain, Dr. Gottlieb said.
“It necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains,” he emphasized.
Strategies to incentivize companies include fast track designation, priority review, and breakthrough therapy designation. In addition, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) is designed to promote development of antimicrobial drugs for limited and underserved populations, Dr. Gottlieb said. The FDA plan also calls for pursuing reimbursement options with the Centers for Medicare & Medicaid Services.
Promoting antimicrobial stewardship remains an ongoing element of the FDA’s plan to reduce AMR. In conjunction with the release of the FDA’s updated approach to AMR, the FDA’s Center for Veterinary Medicine CVM released a 5-year action plan to promote and support antimicrobial stewardship in not only the agricultural arena, but in companion animals as well.
The FDA plans to bring all antimicrobials of medical importance that are approved for use in animals under the oversight of CVM, which will pursue the improve labeling on antimicrobial drugs used in the feed and water of food-producing animals, including defining durations of use, Dr. Gottlieb noted.
Supporting the development and improvement of surveillance tools is “essential to understanding the drivers of resistance in human and veterinary settings and formulating appropriate responses” to outbreaks, Dr. Gottlieb said.
To help meet this goal, the FDA will expand sampling via the National Antimicrobial Resistance Monitoring System (NARMS) database, he said. Other surveillance goals include supporting genomics research and expanding AMR monitoring to include pathogens associated with animal feed and companion animals, he added.
As part of the final component of the FDA’s AMR strategy to advance scientific initiatives, the FDA has released a new Request for Information “to obtain additional, external input on how best to develop an annual list of regulatory science initiatives specific for antimicrobial products,” Dr. Gottlieb announced. The FDA intends to use the information gained from clinicians and others in its creation of guidance documents and recommendations to streamline the antibiotic development process. He also cited the FDA’s ongoing support of partnerships with public and private organizations such as the Clinical Trials Transformation Initiative, which focuses on drug development for severe bacterial infections with current unmet medical need.
“We need to harness science and policy to help our public health systems and researchers become nimbler in the battle against drug-resistant pathogens,” Dr. Gottlieb concluded.
In a panel discussion following the briefing, several experts offered perspective on the FDA’s goals and on the challenges of AMR.
William Flynn, DVM, deputy director of science policy for the Center of Veterinary Medicine, noted some goals for reducing the use of antibiotics in the veterinary arena.
“We are trying to focus on the driver: What are the disease conditions that drive use of the product,” he said. Ideally, better management of disease conditions can reduce reliance on antibiotics, he added.
Also in the panel discussion, Steven Gitterman, MD, deputy director of the division of microbiology devices at the Center for Devices and Radiological Health, emphasized the value of sustainable trial databases so AMR research can continue on an ongoing basis. Finally, Carolyn Wilson, PhD, associate director of research at the Center for Biologics Evaluation and Research, noted that the FDA’s research and development efforts include antibiotic alternatives, including live biotherapeutic products, fecal microbiota transplantation, and bacteriophage therapy.
Visit www.fda.gov for a transcript of Dr. Gottlieb’s talk, and for the updated FDA website page with more details on the agency’s plans to combat antimicrobial resistance.
Dr. Gottlieb and the panelists had no financial conflicts to disclose.
More than half of urine drug screens showed improper medication use
LAS VEGAS –
Of almost 4 million urine screens examined, 52% were discordant for the screen-ordered drugs, Jeffrey Gudin, MD, said at the annual PAINWeek. Most common was the combination of opioids and benzodiazepines, which accounted for 21% of the discordant samples – and, in 64% of these cases, at least one of the drugs was not prescribed.
“Drug testing is a standard of care in pain management, and it’s the only objective way to know what patients are really taking,” said Dr. Gudin, director of pain and palliative care at Englewood (N.J.) Hospital and Medical Center. “What this tells us is that, if we just ask our patients, half the time they won’t tell you the whole story. More than 50% of the time things don’t match up. To me this is just unbelievable.”
Quest Diagnostics compiled these data, and many more, in its “Health Trends Report: Drug Misuse in America 2018.”
The report examines 3.9 million routine drug screens ordered by primary care and pain physicians during 2011-2017. It not only looks at prescription drug use and misuse but also tracks illicit drugs in both general and substance abuse patient populations. The findings reported at PAINWeek were based on 456,675 screens from 276,953 patients conducted in 2017. These results were included in the Quest Diagnostics medMATCH reports, which indicated what tested drugs were prescribed and whether these drugs were detected in the specimen.
The following were found among the discordant screens identified in 2017:
- 45% were positive for nonprescribed or illicit drugs in addition to all the prescribed drugs.
- 34% did not show all the drugs they had been prescribed, or any other tested drug.
- 22% did not show all the drugs they had been prescribed but were positive for other illicit or nonprescribed drugs.
The tests were ordered as a part of routine care – an important point, Dr. Gudin said in an interview. “These are not ‘gotcha tests,’ ” intended to catch patients unawares. “These are regularly ordered screens that are standard of care in pain management.”
The report found that men and women were equally likely to misuse medications (52% each). There were some age-related differences, with misuse peaking in young adulthood: 60% of 18- to 24-year-olds and 56% of 25- to 45-year-olds. Misuse dropped off in those aged 55-64 years (52%) and in those 65 years and older (43%). But even children showed evidence of medication misuse, with about 41% of samples from children aged 10 years and younger being discordant.
The rates of misuse were about 50% in Medicare and private pay patients, but around 65% in Medicaid patients.
There was some good news: In the general patient population, opioid use was down by 12% from 2016 – the largest annual decrease Quest has noted since 2012. Several factors probably contributed to that decline, including shifts in clinical care and payer reimbursement, as well as regulatory and legislative restrictions.
“This shows that we’re doing better on the pain management front,” Dr. Gudin said. “But in substance use disorder settings, we saw 400% increases for both fentanyl and heroin. The addiction front it out of control.”
More than 27% of all specimens that came from substance abuse treatment centers were positive for nonprescribed fentanyl and 10% were positive for heroin. “We also saw that, in 2016, 45% of those heroin-positive samples had fentanyl in them, and in 2017, 83% did.”
Although not discussed at PAINWeek, the report also noted a rise in gabapentin misuse. The antiepileptic is now the 10th most commonly prescribed drug in the United States, the report noted, with 68 million prescriptions dispensed last year. The report found that 9.5% of tests showed nonprescription gabapentin. In the subset of samples obtained from substance abuse treatment centers, gabapentin misuse increased by 800% from 2016 – the most dramatic increase of any of the tracked drugs.
The combination of gabapentin and opioids is risky, the report noted. Opioid-related deaths are 49% more common among those taking both than those taking opioids only.
SOURCE: Gudin J et al. PAINWeek 2018, abstract 44.
LAS VEGAS –
Of almost 4 million urine screens examined, 52% were discordant for the screen-ordered drugs, Jeffrey Gudin, MD, said at the annual PAINWeek. Most common was the combination of opioids and benzodiazepines, which accounted for 21% of the discordant samples – and, in 64% of these cases, at least one of the drugs was not prescribed.
“Drug testing is a standard of care in pain management, and it’s the only objective way to know what patients are really taking,” said Dr. Gudin, director of pain and palliative care at Englewood (N.J.) Hospital and Medical Center. “What this tells us is that, if we just ask our patients, half the time they won’t tell you the whole story. More than 50% of the time things don’t match up. To me this is just unbelievable.”
Quest Diagnostics compiled these data, and many more, in its “Health Trends Report: Drug Misuse in America 2018.”
The report examines 3.9 million routine drug screens ordered by primary care and pain physicians during 2011-2017. It not only looks at prescription drug use and misuse but also tracks illicit drugs in both general and substance abuse patient populations. The findings reported at PAINWeek were based on 456,675 screens from 276,953 patients conducted in 2017. These results were included in the Quest Diagnostics medMATCH reports, which indicated what tested drugs were prescribed and whether these drugs were detected in the specimen.
The following were found among the discordant screens identified in 2017:
- 45% were positive for nonprescribed or illicit drugs in addition to all the prescribed drugs.
- 34% did not show all the drugs they had been prescribed, or any other tested drug.
- 22% did not show all the drugs they had been prescribed but were positive for other illicit or nonprescribed drugs.
The tests were ordered as a part of routine care – an important point, Dr. Gudin said in an interview. “These are not ‘gotcha tests,’ ” intended to catch patients unawares. “These are regularly ordered screens that are standard of care in pain management.”
The report found that men and women were equally likely to misuse medications (52% each). There were some age-related differences, with misuse peaking in young adulthood: 60% of 18- to 24-year-olds and 56% of 25- to 45-year-olds. Misuse dropped off in those aged 55-64 years (52%) and in those 65 years and older (43%). But even children showed evidence of medication misuse, with about 41% of samples from children aged 10 years and younger being discordant.
The rates of misuse were about 50% in Medicare and private pay patients, but around 65% in Medicaid patients.
There was some good news: In the general patient population, opioid use was down by 12% from 2016 – the largest annual decrease Quest has noted since 2012. Several factors probably contributed to that decline, including shifts in clinical care and payer reimbursement, as well as regulatory and legislative restrictions.
“This shows that we’re doing better on the pain management front,” Dr. Gudin said. “But in substance use disorder settings, we saw 400% increases for both fentanyl and heroin. The addiction front it out of control.”
More than 27% of all specimens that came from substance abuse treatment centers were positive for nonprescribed fentanyl and 10% were positive for heroin. “We also saw that, in 2016, 45% of those heroin-positive samples had fentanyl in them, and in 2017, 83% did.”
Although not discussed at PAINWeek, the report also noted a rise in gabapentin misuse. The antiepileptic is now the 10th most commonly prescribed drug in the United States, the report noted, with 68 million prescriptions dispensed last year. The report found that 9.5% of tests showed nonprescription gabapentin. In the subset of samples obtained from substance abuse treatment centers, gabapentin misuse increased by 800% from 2016 – the most dramatic increase of any of the tracked drugs.
The combination of gabapentin and opioids is risky, the report noted. Opioid-related deaths are 49% more common among those taking both than those taking opioids only.
SOURCE: Gudin J et al. PAINWeek 2018, abstract 44.
LAS VEGAS –
Of almost 4 million urine screens examined, 52% were discordant for the screen-ordered drugs, Jeffrey Gudin, MD, said at the annual PAINWeek. Most common was the combination of opioids and benzodiazepines, which accounted for 21% of the discordant samples – and, in 64% of these cases, at least one of the drugs was not prescribed.
“Drug testing is a standard of care in pain management, and it’s the only objective way to know what patients are really taking,” said Dr. Gudin, director of pain and palliative care at Englewood (N.J.) Hospital and Medical Center. “What this tells us is that, if we just ask our patients, half the time they won’t tell you the whole story. More than 50% of the time things don’t match up. To me this is just unbelievable.”
Quest Diagnostics compiled these data, and many more, in its “Health Trends Report: Drug Misuse in America 2018.”
The report examines 3.9 million routine drug screens ordered by primary care and pain physicians during 2011-2017. It not only looks at prescription drug use and misuse but also tracks illicit drugs in both general and substance abuse patient populations. The findings reported at PAINWeek were based on 456,675 screens from 276,953 patients conducted in 2017. These results were included in the Quest Diagnostics medMATCH reports, which indicated what tested drugs were prescribed and whether these drugs were detected in the specimen.
The following were found among the discordant screens identified in 2017:
- 45% were positive for nonprescribed or illicit drugs in addition to all the prescribed drugs.
- 34% did not show all the drugs they had been prescribed, or any other tested drug.
- 22% did not show all the drugs they had been prescribed but were positive for other illicit or nonprescribed drugs.
The tests were ordered as a part of routine care – an important point, Dr. Gudin said in an interview. “These are not ‘gotcha tests,’ ” intended to catch patients unawares. “These are regularly ordered screens that are standard of care in pain management.”
The report found that men and women were equally likely to misuse medications (52% each). There were some age-related differences, with misuse peaking in young adulthood: 60% of 18- to 24-year-olds and 56% of 25- to 45-year-olds. Misuse dropped off in those aged 55-64 years (52%) and in those 65 years and older (43%). But even children showed evidence of medication misuse, with about 41% of samples from children aged 10 years and younger being discordant.
The rates of misuse were about 50% in Medicare and private pay patients, but around 65% in Medicaid patients.
There was some good news: In the general patient population, opioid use was down by 12% from 2016 – the largest annual decrease Quest has noted since 2012. Several factors probably contributed to that decline, including shifts in clinical care and payer reimbursement, as well as regulatory and legislative restrictions.
“This shows that we’re doing better on the pain management front,” Dr. Gudin said. “But in substance use disorder settings, we saw 400% increases for both fentanyl and heroin. The addiction front it out of control.”
More than 27% of all specimens that came from substance abuse treatment centers were positive for nonprescribed fentanyl and 10% were positive for heroin. “We also saw that, in 2016, 45% of those heroin-positive samples had fentanyl in them, and in 2017, 83% did.”
Although not discussed at PAINWeek, the report also noted a rise in gabapentin misuse. The antiepileptic is now the 10th most commonly prescribed drug in the United States, the report noted, with 68 million prescriptions dispensed last year. The report found that 9.5% of tests showed nonprescription gabapentin. In the subset of samples obtained from substance abuse treatment centers, gabapentin misuse increased by 800% from 2016 – the most dramatic increase of any of the tracked drugs.
The combination of gabapentin and opioids is risky, the report noted. Opioid-related deaths are 49% more common among those taking both than those taking opioids only.
SOURCE: Gudin J et al. PAINWeek 2018, abstract 44.
REPORTING FROM PAINWEEK 2018
Key clinical point: More than half of patients undergoing urine drug screens were misusing medications.
Major finding: The samples were discordant for the queried drug in 52% of samples.
Study details: The study was based on 3.9 million drug screens ordered during 2011-2017.
Disclosures: The findings were included in Quest Diagnostics’ “Health Trends Report: Drug Misuse in America 2018.”
Source: Gudin J et al. PAINWeek, Abstract 44.
Zika virus infection: Novel assay extends diagnostic window
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
REPORTING FROM ICEID 2018
Key clinical point: A novel assay extends the time frame for diagnosing Zika virus infection.
Major finding: The PSQ assay detected and sequence confirmed Zika virus in all 60 samples; 40 negative control samples all tested negative.
Study details: An analysis of 60 tissue samples using a novel assay.
Disclosures: Dr. Bhatnagar reported having no disclosures.
Source: Bhatnagar J et al. ICEID 2018, Abstract O1.
New stroke intervention guidelines stress volume
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
A consensus working group from numerous international societies has published new guidelines for standards of practice in the treatment of acute ischemic stroke (AIS). The new guidelines differ somewhat from the Joint Commission guideline, released in 2015, primarily by raising the bar for the number of mechanical thrombectomy (MT) procedures that level 1 and level 2 stroke centers should perform annually in order to maintain a minimum safety threshold.
Previous studies have shown lower mortality in high-volume centers, but setting minimum standards can be a challenge, especially in under-served countries and localities. The authors, led by first author Laurent Pierot, MD, PhD, of University Hospital Reims (France), acknowledge that newly established level 2 centers may struggle to meet the minimum requirement for MT procedures, but that this is acceptable as long as the volume is expected to meet the minimum within 12-24 months.
The guidelines were created by a working group of delegates from 13 international societies, including the American Society of Neuroradiology, European Stroke Organization, World Stroke Organization, and the Society of NeuroInterventional Surgery.
The publication in 2015 of studies showing the efficacy of MT in anterior circulation emergent large-vessel occlusion (ELVO) stroke patients reverberated through the stroke care community, but posed a challenge in delivering this therapy to populations in diverse localities that have no access to level 1 stroke centers.
The guidelines, published online in the Journal of NeuroInterventional Surgery, aim to ensure that facilities can handle not only the MT procedure, but also the medical management before, during, and after the procedure.
According to the new guidelines, level 2 centers should handle cases when a level 1 center cannot be reached within 2 hours. Level 2 centers should care for at least 100 AIS patients per year and should also have a relationship with a level 1 center to maintain staff training, teleconsultations, referrals, and other collaborations.
Previous studies have identified 35 or 36 MT procedures annually as a threshold to be considered “high volume,” a category that led to lower mortality. The new recommendations fall below that threshold because they are intended to apply broadly, to regions that may be under-served. In highly developed countries, stroke centers should follow regional or national guidelines that have higher limits.
Level 2 centers should perform at least 50 intracranial thrombectomy procedures for ELVO, and a total of 120 diagnostic or interventional neuroendovascular procedures per year. Individual interventionists should conduct at least 15 intracranial thrombectomy and 50 interventional neuroendovascular procedures per year.
Other recommendations cover additional details about personnel, as well as community and emergency medical services outreach.
In many ways, the recommendations are in line with the Joint Commission (TJC), according to David Tirschwell, MD, who is the medical director for the UW Medicine* Comprehensive Stroke Center at Harborview Medical Center, Seattle. He was not involved in the development of the new guidelines.
Dr. Tirschwell noted one key difference with respect to the number of MT procedures required to qualify. TJC offered no minimum annual procedures for Comprehensive Stroke Centers (equivalent to level 1), and only 15 for Thrombectomy Capable Stroke Centers (level 2), versus 50 in the new guidelines. The minimum procedure numbers are also higher for individual clinicians.
The guidelines also recommend that level 2 centers have at least three interventionalists on staff available at all times, while TJC does not address this element of staffing.
“The higher minimum number of procedures in the new international recommendations is a substantial difference and would make it harder for many hospitals to qualify, compared to the TJC requirements. As such, a lower number of hospitals may qualify, and such a barrier could prevent access to mechanical thrombectomy for many patients. On the other hand, the higher minimum number may ensure a higher quality of care, which can be seen as a strong positive feature,” Dr. Tirschwell said.
A spokesman for the Joint Commission and the American Heart Association indicated that they will review the new guidelines and consider whether to make changes to their 2015 guidelines.
SOURCE: Pierot Laurent et al. J Neurointervent Surg. 2018 Aug 28. doi: 10.1136/neurintsurg-2018-014287.
*Updated Sept. 14, 2018.
FROM THE JOURNAL OF NEUROINTERVENTIONAL SURGERY
NYC outbreak of Candida auris linked to 45% mortality
Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.
Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.
“Intensive infection prevention and control efforts continue; the goals are delaying endemicity, preventing outbreaks within facilities, reducing transmission and geographic spread, and blunting the effect of C. auris in New York and the rest of the United States,” Eleanor Adams, MD, of the New York Health Department, and her colleagues wrote. “Among medically fragile patients in NYC who had a history of extensive contact with health care facilities, clinicians should include C. auris in the differential diagnosis for patients with symptoms compatible with bloodstream infection.”
In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.
Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.
Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.
The work was supported by the CDC. No disclosures were reported.
SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.
Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.
Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.
“Intensive infection prevention and control efforts continue; the goals are delaying endemicity, preventing outbreaks within facilities, reducing transmission and geographic spread, and blunting the effect of C. auris in New York and the rest of the United States,” Eleanor Adams, MD, of the New York Health Department, and her colleagues wrote. “Among medically fragile patients in NYC who had a history of extensive contact with health care facilities, clinicians should include C. auris in the differential diagnosis for patients with symptoms compatible with bloodstream infection.”
In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.
Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.
Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.
The work was supported by the CDC. No disclosures were reported.
SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.
Mortality within 90 days of infection was 45% among 51 patients diagnosed with antibiotic-resistant Candida auris infections in a multihospital outbreak in New York City from 2012 to 2017.
Transmission is ongoing in health care facilities, primarily among patients with extensive health care exposures, according to a report published in Emerging Infectious Diseases.
“Intensive infection prevention and control efforts continue; the goals are delaying endemicity, preventing outbreaks within facilities, reducing transmission and geographic spread, and blunting the effect of C. auris in New York and the rest of the United States,” Eleanor Adams, MD, of the New York Health Department, and her colleagues wrote. “Among medically fragile patients in NYC who had a history of extensive contact with health care facilities, clinicians should include C. auris in the differential diagnosis for patients with symptoms compatible with bloodstream infection.”
In the intensive case-patient analysis conducted by the New York State Health Department, 21 cases were from seven hospitals in Brooklyn, 16 were from three hospitals and one private medical office in Queens, 12 were from five hospitals and one long-term acute care hospital in Manhattan, and 1 was from a hospital in the Bronx. The remaining clinical case was identified in a western New York hospital in a patient who had recently been admitted to an involved Brooklyn hospital.
Among these patients, 31 (61%) had resided in long-term care facilities immediately before being admitted to the hospital in which their infection was diagnosed, and 19 of these 31 resided in skilled nursing facilities with ventilator beds; 1 (2%) resided in a long-term acute care hospital; 5 (10%) had been transferred from another hospital; and 4 (8%) had traveled internationally within 5 years before diagnosis, according to the investigators.
Isolates from 50 patients (98%) were resistant to fluconazole and 13 (25%) were resistant to fluconazole and amphotericin B. No initial isolates were resistant to echinocandins, although subsequent isolates obtained from 3 persons who had received an echinocandin acquired resistance to it, according to the researchers. Whole-genome sequencing performed at The Centers for Disease Control and Prevention indicated that 50 of 51 isolates belonged to a South Asia clade; the remaining isolate was the only one susceptible to fluconazole.
The work was supported by the CDC. No disclosures were reported.
SOURCE: Adams E et al. Emerg Infect Dis. 2018 Sep 12; 24(10); ID: 18-0649.
FROM EMERGING INFECTIOUS DISEASES