Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it to gtwachtman@mdedge.com.

Physicians will soon start having an easier time – and perhaps get paid more money – when they code for evaluation and management (E/M) services, thanks to the American Medical Association.

The first major changes to the definitions for E/M services will be in effect as of Jan. 1, 2021, with all payers expected to adopt these new guidelines. In particular, the AMA has revised the definitions for E/M codes 99202-99215 in the Current Procedural Terminology (CPT) 2021 codebook. The existing guidelines were developed in 1995 and 1997 and remain in effect for all other E/M services determined by history, exam, and medical decision-making (MDM).

What do the new changes mean to you? In 2021, for new and established office and other outpatient services reported with codes 99202-99215, a clinician may select the code on the basis of time or MDM.

There are three elements in MDM, and two of three are required. These elements are the number and complexity of problems addressed, amount and/or complexity of data to be reviewed and analyzed, and risk of complications and/or morbidity or mortality of patient management.

Make sure you familiarize yourself with these six big changes. It may take a bit of time to integrate these new processes into your daily routine, but wrapping your head around them as soon as possible can help boost your bottom line:
 

1. History and exam don’t count toward level of service

Physicians, advanced practice registered nurses, and physician assistants won’t use history or exam to select what level of code to bill for office visits 99202-99215, as they did in the past. They need only document a medically appropriate history and exam. The history may be obtained by staff members and reviewed by the billing practitioner.

While specific history and exam requirements disappear for office visit codes, they remain for all other types of visits, selected on the basis of history, exam, and MDM, such as hospital services, nursing facility services, and home and domiciliary care. So, say goodbye to “all other systems reviewed and negative” in office notes, but keep it handy for those other E/M codes.

2. All time spent caring for the patient on a particular day counts

This includes all time spent on the day of service, including preparing to see the patient, seeing the patient, phone calls or other work done after the visit (if not billed with a care management or other CPT code), and documenting in the medical record. The AMA developed new guidelines for using time for office and other outpatient services. For codes 99202-99215, count all of the face-to-face and non–face-to-face time spent by the billing clinician on the day of the visit. Counseling does not need to be more than 50% of the total time.

Do not include any staff time or time spent on any days before or after the visit. This allows clinicians to capture the work when a significant amount of it takes place before or after the visit with the patient, and to bill for it on the day of the visit.

According to the 2021 CPT codebook, physician or other qualified health care professional time includes the following activities:

• Preparing to see the patient (e.g., review of tests).
• Obtaining and/or reviewing separately obtained history.
• Performing a medically appropriate examination and/or evaluation.
• Counseling and educating the patient/family/caregiver.
• Ordering medications, tests, or procedures.
• Referring and communicating with other health care professionals (when not separately reported).
• Documenting clinical information in the electronic or other health record.
• Independently interpreting results (not separately reported) and communicating results to the patient/family/caregiver.
• Care coordination (not separately reported).

3. Soon to be gone: ‘new to the examiner’ and ‘workup planned’

The current guidelines don’t differentiate between a new problem to the clinician or an established problem to the clinician. So it doesn’t matter whether you’re hearing about a particular problem for the first time or the fifth time. The new office and outpatient services guidelines define problems only as they relate to the patient. For example, when selecting a level of service, a chronic problem with a mild exacerbation is the same level whether it’s the primary care physician seeing the patient for the 10th time to help manage her diabetes or the endocrinologist seeing the patient for the first time.

In the current guidelines (1995 and 1997), additional weight is given in selecting the level of MDM for a problem that’s new to the examiner with a workup planned, yet when the diagnostic test couldn’t be completed at the visit. This concept is gone from element of number and complexity of new problems. Ordering diagnostic tests is part of the second element, the amount and/or complexity of data to be reviewed.

4. Different guidelines if you need a history from a parent or other source

The new guidelines recognize the additional work required by the clinician when the patient is unable to give a history or when the practitioner doesn’t find the history to be reliable.

For example, in the case of a baby or child who is unable to give a history, the parent counts as an “independent historian,” according to the new guidelines. Likewise, for a patient with dementia, the caregiver counts as a historian. Note, however, that the criteria is not met simply because the patient is accompanied by another person. The additional weight in selecting the level of service is based on the patient being unable to give a reliable history.

Bottom line: In cases where patients are unable to communicate clearly, physicians or other providers should document the necessity of getting a complete history and who provided it.

5. A new spin on social determinants of health (SDoH)

In the risk of morbidity and/or mortality element, conditions described as “social determinants of health” are considered moderate complexity. SDoH are social and environmental factors that affect a patient’s health and medical outcomes. These include homelessness, inability to afford medications, food insecurity, and occupational exposure to risk factors. These circumstances are reported with codes in categories Z55-Z65.

In the past, physicians often documented this information in their office notes but rarely added a diagnosis code that described the patient’s situation. The ICD-10-CM code set includes codes that describe these factors. Using them allows the practice to track patients who have increased needs, and it communicates to payers the complexity of caring for these patients.

6. Risks related to surgery are defined

The current guidelines assign different levels of risk to minor and major surgery. They also include differentiation for “minor surgery with no identified risk factors,” “minor surgery with identified risk factors,” “elective major surgery with no identified risk factors,” and “elective major surgery with identified risk factors.” The old guidelines didn’t state whether the risk factors pertained to the patient – such as smoking, heart disease, or high body mass index – or to the procedure itself.

The new guidelines specifically say that it’s both. In the risk column, “decision regarding minor surgery with identified patient or procedure risk factors” and “decision regarding elective major surgery without patient or procedure risk factors” are both considered moderate. “Decision regarding elective major surgery with identified patient or procedure risk factors” and “decision regarding emergency major surgery” are in the high complexity column for risk.

Keep in mind that two of three elements are required: the number and complexity of problems, amount of data, and morbidity/mortality risk. Risk of morbidity/mortality alone doesn’t count as the basis for selecting the code. Of course, when surgeons see this, they ask, “What major procedures don’t have identified risk factors?”

Note, too, that these new CPT guidelines do not define the terms “minor” and “major” surgery. For payment reasons related to the postop period, the Centers for Medicare & Medicaid Services defines minor surgery as a procedure with 0-10 global days and a major surgery as a procedure with 90 global days. However, there are many procedures with 0 global days (endoscopy, cardiac catheterization) that are not minor procedures. Hopefully, the AMA will clarify this in 2021.
 

What’s the take-away for clinicians?

There are sure to be shifts in coding patterns based on these new guidelines. Some specialties will find that not being able to select a service based on history and exam alone will lower the level of service for which they can bill. Some practices, on the other hand, will be able to code for more high-level visits, without the need for a complete review of systems or a comprehensive exam.

The biggest challenge will be for practices that provide services both in the hospital and in the office, because they’ll have to use both sets of guidelines, depending on which type of service they’re performing.

For more details on what’s coming your way beginning on New Year’s Day, you may want to read the 16-page AMA document .
 

A version of this article first appeared on Medscape.com.

Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it to gtwachtman@mdedge.com.

Physicians will soon start having an easier time – and perhaps get paid more money – when they code for evaluation and management (E/M) services, thanks to the American Medical Association.

The first major changes to the definitions for E/M services will be in effect as of Jan. 1, 2021, with all payers expected to adopt these new guidelines. In particular, the AMA has revised the definitions for E/M codes 99202-99215 in the Current Procedural Terminology (CPT) 2021 codebook. The existing guidelines were developed in 1995 and 1997 and remain in effect for all other E/M services determined by history, exam, and medical decision-making (MDM).

What do the new changes mean to you? In 2021, for new and established office and other outpatient services reported with codes 99202-99215, a clinician may select the code on the basis of time or MDM.

There are three elements in MDM, and two of three are required. These elements are the number and complexity of problems addressed, amount and/or complexity of data to be reviewed and analyzed, and risk of complications and/or morbidity or mortality of patient management.

Make sure you familiarize yourself with these six big changes. It may take a bit of time to integrate these new processes into your daily routine, but wrapping your head around them as soon as possible can help boost your bottom line:
 

1. History and exam don’t count toward level of service

Physicians, advanced practice registered nurses, and physician assistants won’t use history or exam to select what level of code to bill for office visits 99202-99215, as they did in the past. They need only document a medically appropriate history and exam. The history may be obtained by staff members and reviewed by the billing practitioner.

While specific history and exam requirements disappear for office visit codes, they remain for all other types of visits, selected on the basis of history, exam, and MDM, such as hospital services, nursing facility services, and home and domiciliary care. So, say goodbye to “all other systems reviewed and negative” in office notes, but keep it handy for those other E/M codes.

2. All time spent caring for the patient on a particular day counts

This includes all time spent on the day of service, including preparing to see the patient, seeing the patient, phone calls or other work done after the visit (if not billed with a care management or other CPT code), and documenting in the medical record. The AMA developed new guidelines for using time for office and other outpatient services. For codes 99202-99215, count all of the face-to-face and non–face-to-face time spent by the billing clinician on the day of the visit. Counseling does not need to be more than 50% of the total time.

Do not include any staff time or time spent on any days before or after the visit. This allows clinicians to capture the work when a significant amount of it takes place before or after the visit with the patient, and to bill for it on the day of the visit.

According to the 2021 CPT codebook, physician or other qualified health care professional time includes the following activities:

• Preparing to see the patient (e.g., review of tests).
• Obtaining and/or reviewing separately obtained history.
• Performing a medically appropriate examination and/or evaluation.
• Counseling and educating the patient/family/caregiver.
• Ordering medications, tests, or procedures.
• Referring and communicating with other health care professionals (when not separately reported).
• Documenting clinical information in the electronic or other health record.
• Independently interpreting results (not separately reported) and communicating results to the patient/family/caregiver.
• Care coordination (not separately reported).

3. Soon to be gone: ‘new to the examiner’ and ‘workup planned’

The current guidelines don’t differentiate between a new problem to the clinician or an established problem to the clinician. So it doesn’t matter whether you’re hearing about a particular problem for the first time or the fifth time. The new office and outpatient services guidelines define problems only as they relate to the patient. For example, when selecting a level of service, a chronic problem with a mild exacerbation is the same level whether it’s the primary care physician seeing the patient for the 10th time to help manage her diabetes or the endocrinologist seeing the patient for the first time.

In the current guidelines (1995 and 1997), additional weight is given in selecting the level of MDM for a problem that’s new to the examiner with a workup planned, yet when the diagnostic test couldn’t be completed at the visit. This concept is gone from element of number and complexity of new problems. Ordering diagnostic tests is part of the second element, the amount and/or complexity of data to be reviewed.

4. Different guidelines if you need a history from a parent or other source

The new guidelines recognize the additional work required by the clinician when the patient is unable to give a history or when the practitioner doesn’t find the history to be reliable.

For example, in the case of a baby or child who is unable to give a history, the parent counts as an “independent historian,” according to the new guidelines. Likewise, for a patient with dementia, the caregiver counts as a historian. Note, however, that the criteria is not met simply because the patient is accompanied by another person. The additional weight in selecting the level of service is based on the patient being unable to give a reliable history.

Bottom line: In cases where patients are unable to communicate clearly, physicians or other providers should document the necessity of getting a complete history and who provided it.

5. A new spin on social determinants of health (SDoH)

In the risk of morbidity and/or mortality element, conditions described as “social determinants of health” are considered moderate complexity. SDoH are social and environmental factors that affect a patient’s health and medical outcomes. These include homelessness, inability to afford medications, food insecurity, and occupational exposure to risk factors. These circumstances are reported with codes in categories Z55-Z65.

In the past, physicians often documented this information in their office notes but rarely added a diagnosis code that described the patient’s situation. The ICD-10-CM code set includes codes that describe these factors. Using them allows the practice to track patients who have increased needs, and it communicates to payers the complexity of caring for these patients.

6. Risks related to surgery are defined

The current guidelines assign different levels of risk to minor and major surgery. They also include differentiation for “minor surgery with no identified risk factors,” “minor surgery with identified risk factors,” “elective major surgery with no identified risk factors,” and “elective major surgery with identified risk factors.” The old guidelines didn’t state whether the risk factors pertained to the patient – such as smoking, heart disease, or high body mass index – or to the procedure itself.

The new guidelines specifically say that it’s both. In the risk column, “decision regarding minor surgery with identified patient or procedure risk factors” and “decision regarding elective major surgery without patient or procedure risk factors” are both considered moderate. “Decision regarding elective major surgery with identified patient or procedure risk factors” and “decision regarding emergency major surgery” are in the high complexity column for risk.

Keep in mind that two of three elements are required: the number and complexity of problems, amount of data, and morbidity/mortality risk. Risk of morbidity/mortality alone doesn’t count as the basis for selecting the code. Of course, when surgeons see this, they ask, “What major procedures don’t have identified risk factors?”

Note, too, that these new CPT guidelines do not define the terms “minor” and “major” surgery. For payment reasons related to the postop period, the Centers for Medicare & Medicaid Services defines minor surgery as a procedure with 0-10 global days and a major surgery as a procedure with 90 global days. However, there are many procedures with 0 global days (endoscopy, cardiac catheterization) that are not minor procedures. Hopefully, the AMA will clarify this in 2021.
 

What’s the take-away for clinicians?

There are sure to be shifts in coding patterns based on these new guidelines. Some specialties will find that not being able to select a service based on history and exam alone will lower the level of service for which they can bill. Some practices, on the other hand, will be able to code for more high-level visits, without the need for a complete review of systems or a comprehensive exam.

The biggest challenge will be for practices that provide services both in the hospital and in the office, because they’ll have to use both sets of guidelines, depending on which type of service they’re performing.

For more details on what’s coming your way beginning on New Year’s Day, you may want to read the 16-page AMA document .
 

A version of this article first appeared on Medscape.com.

Betsy Nicoletti, MS, a nationally recognized coding expert, will take your coding questions via email and provide guidance on how to code properly to maximize reimbursement. Have a question about coding? Send it to gtwachtman@mdedge.com.

Physicians will soon start having an easier time – and perhaps get paid more money – when they code for evaluation and management (E/M) services, thanks to the American Medical Association.

The first major changes to the definitions for E/M services will be in effect as of Jan. 1, 2021, with all payers expected to adopt these new guidelines. In particular, the AMA has revised the definitions for E/M codes 99202-99215 in the Current Procedural Terminology (CPT) 2021 codebook. The existing guidelines were developed in 1995 and 1997 and remain in effect for all other E/M services determined by history, exam, and medical decision-making (MDM).

What do the new changes mean to you? In 2021, for new and established office and other outpatient services reported with codes 99202-99215, a clinician may select the code on the basis of time or MDM.

There are three elements in MDM, and two of three are required. These elements are the number and complexity of problems addressed, amount and/or complexity of data to be reviewed and analyzed, and risk of complications and/or morbidity or mortality of patient management.

Make sure you familiarize yourself with these six big changes. It may take a bit of time to integrate these new processes into your daily routine, but wrapping your head around them as soon as possible can help boost your bottom line:
 

1. History and exam don’t count toward level of service

Physicians, advanced practice registered nurses, and physician assistants won’t use history or exam to select what level of code to bill for office visits 99202-99215, as they did in the past. They need only document a medically appropriate history and exam. The history may be obtained by staff members and reviewed by the billing practitioner.

While specific history and exam requirements disappear for office visit codes, they remain for all other types of visits, selected on the basis of history, exam, and MDM, such as hospital services, nursing facility services, and home and domiciliary care. So, say goodbye to “all other systems reviewed and negative” in office notes, but keep it handy for those other E/M codes.

2. All time spent caring for the patient on a particular day counts

This includes all time spent on the day of service, including preparing to see the patient, seeing the patient, phone calls or other work done after the visit (if not billed with a care management or other CPT code), and documenting in the medical record. The AMA developed new guidelines for using time for office and other outpatient services. For codes 99202-99215, count all of the face-to-face and non–face-to-face time spent by the billing clinician on the day of the visit. Counseling does not need to be more than 50% of the total time.

Do not include any staff time or time spent on any days before or after the visit. This allows clinicians to capture the work when a significant amount of it takes place before or after the visit with the patient, and to bill for it on the day of the visit.

According to the 2021 CPT codebook, physician or other qualified health care professional time includes the following activities:

• Preparing to see the patient (e.g., review of tests).
• Obtaining and/or reviewing separately obtained history.
• Performing a medically appropriate examination and/or evaluation.
• Counseling and educating the patient/family/caregiver.
• Ordering medications, tests, or procedures.
• Referring and communicating with other health care professionals (when not separately reported).
• Documenting clinical information in the electronic or other health record.
• Independently interpreting results (not separately reported) and communicating results to the patient/family/caregiver.
• Care coordination (not separately reported).

3. Soon to be gone: ‘new to the examiner’ and ‘workup planned’

The current guidelines don’t differentiate between a new problem to the clinician or an established problem to the clinician. So it doesn’t matter whether you’re hearing about a particular problem for the first time or the fifth time. The new office and outpatient services guidelines define problems only as they relate to the patient. For example, when selecting a level of service, a chronic problem with a mild exacerbation is the same level whether it’s the primary care physician seeing the patient for the 10th time to help manage her diabetes or the endocrinologist seeing the patient for the first time.

In the current guidelines (1995 and 1997), additional weight is given in selecting the level of MDM for a problem that’s new to the examiner with a workup planned, yet when the diagnostic test couldn’t be completed at the visit. This concept is gone from element of number and complexity of new problems. Ordering diagnostic tests is part of the second element, the amount and/or complexity of data to be reviewed.

4. Different guidelines if you need a history from a parent or other source

The new guidelines recognize the additional work required by the clinician when the patient is unable to give a history or when the practitioner doesn’t find the history to be reliable.

For example, in the case of a baby or child who is unable to give a history, the parent counts as an “independent historian,” according to the new guidelines. Likewise, for a patient with dementia, the caregiver counts as a historian. Note, however, that the criteria is not met simply because the patient is accompanied by another person. The additional weight in selecting the level of service is based on the patient being unable to give a reliable history.

Bottom line: In cases where patients are unable to communicate clearly, physicians or other providers should document the necessity of getting a complete history and who provided it.

5. A new spin on social determinants of health (SDoH)

In the risk of morbidity and/or mortality element, conditions described as “social determinants of health” are considered moderate complexity. SDoH are social and environmental factors that affect a patient’s health and medical outcomes. These include homelessness, inability to afford medications, food insecurity, and occupational exposure to risk factors. These circumstances are reported with codes in categories Z55-Z65.

In the past, physicians often documented this information in their office notes but rarely added a diagnosis code that described the patient’s situation. The ICD-10-CM code set includes codes that describe these factors. Using them allows the practice to track patients who have increased needs, and it communicates to payers the complexity of caring for these patients.

6. Risks related to surgery are defined

The current guidelines assign different levels of risk to minor and major surgery. They also include differentiation for “minor surgery with no identified risk factors,” “minor surgery with identified risk factors,” “elective major surgery with no identified risk factors,” and “elective major surgery with identified risk factors.” The old guidelines didn’t state whether the risk factors pertained to the patient – such as smoking, heart disease, or high body mass index – or to the procedure itself.

The new guidelines specifically say that it’s both. In the risk column, “decision regarding minor surgery with identified patient or procedure risk factors” and “decision regarding elective major surgery without patient or procedure risk factors” are both considered moderate. “Decision regarding elective major surgery with identified patient or procedure risk factors” and “decision regarding emergency major surgery” are in the high complexity column for risk.

Keep in mind that two of three elements are required: the number and complexity of problems, amount of data, and morbidity/mortality risk. Risk of morbidity/mortality alone doesn’t count as the basis for selecting the code. Of course, when surgeons see this, they ask, “What major procedures don’t have identified risk factors?”

Note, too, that these new CPT guidelines do not define the terms “minor” and “major” surgery. For payment reasons related to the postop period, the Centers for Medicare & Medicaid Services defines minor surgery as a procedure with 0-10 global days and a major surgery as a procedure with 90 global days. However, there are many procedures with 0 global days (endoscopy, cardiac catheterization) that are not minor procedures. Hopefully, the AMA will clarify this in 2021.
 

What’s the take-away for clinicians?

There are sure to be shifts in coding patterns based on these new guidelines. Some specialties will find that not being able to select a service based on history and exam alone will lower the level of service for which they can bill. Some practices, on the other hand, will be able to code for more high-level visits, without the need for a complete review of systems or a comprehensive exam.

The biggest challenge will be for practices that provide services both in the hospital and in the office, because they’ll have to use both sets of guidelines, depending on which type of service they’re performing.

For more details on what’s coming your way beginning on New Year’s Day, you may want to read the 16-page AMA document .
 

A version of this article first appeared on Medscape.com.

UPDATED DECEMBER 17

A panel of federal advisers on Tuesday effectively backed a bid to expand approval of sacubitril/valsartan for use in a form of heart failure for which there is not yet an approved medication.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The U.S. Food and Drug Administration asked its Cardiovascular and Renal Drugs Advisory Committee to broadly consider whether new analyses of data from the PARAGON-HF trial, combined with other information, could support use of sacubitril/valsartan (Entresto, Novartis) in heart failure with preserved ejection fraction (HFpEF).

The advisory committee voted 12-1 on this question, which can be seen as a marker for an expanded approval: “Does PARAGON-HF, perhaps supported by previous studies, provide sufficient evidence to support any indication?”

The dissenting vote was cast by the panel’s chairperson, Julia B. Lewis, MD, a professor of medicine from Vanderbilt University. In explaining her vote, Dr. Lewis cited concerns about expanding use of the drug, which has a potential for hypotension. But she noted that the rest of the panelists were “impressed by the totality of the evidence” presented, including a willingness to take a new look at the PARAGON-HF trial. This study was perceived at first pass as having failed to prove a benefit for people with HFpEF.

The 2019 initial unveiling of the PARAGON-HF results had dampened hopes for an evidence-based drug therapy for HFpEF. Patients treated with the first-of-its-kind renin-angiotensin system (RAS) inhibitor, compared with those who received standard valsartan, had 13% fewer heart failure hospitalizations or cardiovascular (CV) deaths over an average of about 3 years, but the difference missed significance at a P value of .059.

“Everybody agreed that the P value of .05 was not written in stone,” Dr. Lewis said in summarizing the panelists’ views on the voting question.

At the FDA’s request, the panel also addressed several other questions without voting on them. The agency asked the panel to describe the patient population for whom an expanded approval would be appropriate. The FDA initially approved sacubitril/valsartan in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Novartis in April submitted an application to the FDA, seeking to expand the use of sacubitril/valsartan from the currently approved indication for the treatment of chronic heart failure (CHF) patients with reduced ejection fraction (HFrEF) to include what the company terms “the adjacent population of patients with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) below normal.” The American Society of Echocardiography and European Association of Cardiovascular Imaging define normal LVEF and normal range (±2 standard deviations) as 62% (range, 52%-72%) in men and 64% (range, 54%-74%) in women, Novartis said in its briefing materials for the meeting.

FDA panelist Christopher M. O’Connor, MD, for example, suggested that an expanded approval could allow for use of sacubitril/valsartan for the reduction of heart failure or hospitalization in patients with mildly reduced ejection fraction as defined by greater than 45% through 55%. FDA panelist C. Noel Bairey Merz, MD, director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles, suggested extending this to 57% to acknowledge the higher threshold for women.

Another FDA panelist, Steven E. Nissen, MD, of the Cleveland Clinic, argued against use of imprecise terms in defining an expanded patient population for sacubitril/valsartan. If used in the right patient population, the drug could provide a benefit for people who have active heart failure with symptoms, including preventing hospitalizations and renal disease, he said.

“If you are symptomatic with a syndrome that’s consistent with heart failure and you have an ejection fraction below the lower limits of normal, I believe it’s in the public interest for you to get sacubitril/valsartan,” Dr. Nissen said.

The FDA usually follows the advice of its panels, but is not obligated to. But in this case, the agency staff were clearly seeking a path for an expanded approval of sacubitril/valsartan.


 

Challenging a standard

The FDA had encouraged Novartis to submit the supplementary application for the HFpEF indication and even suggested some of the post-hoc analyses, the agency staff said in a briefing document for the meeting.

PARAGON-HF illustrated some of the agency’s concerns about missed opportunities in general in large research trials. Some events of interest in studies may be miscounted due to a lack of information such as a requirement for the presence of physical examination findings that are not documented in the patient’s dossier, the FDA staff said.

“We would like to consider giving ‘partial credit’ to events based on the level of evidence provided, e.g., use of an ordinal variable rather than a dichotomous ‘yes’ or ‘no,’ ” the staff said in the briefing document.

At the panel meeting, Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, told the panelists there is no basis in law for setting a P value of .05 as the benchmark on whether to declare a trial a success or failure.

“I wanted to take a few minutes and make sure that you on the committee understands what flexibility you have in addressing the case study in question,” Dr. Stockbridge said at the start of the meeting.

He then reviewed cases where the FDA had approved claims for cardiac medicines that had not shown desired results in key tests. These include approval of enalapril for use in asymptomatic left ventricular dysfunction on the basis of the SOLVD-Prevention trial, approval of digoxin for heart failure on the basis of the DIG study, and approval of carvedilol for reduced ejection fraction following myocardial infarction on

the basis of the CAPRICORN study, Dr. Stockbridge said.

In reviewing the data for sacubitril/valsartan, FDA staff noted a similarity between investigator-reported and adjudicated results, Stockbridge said.

“This suggested that there were events that did not need all evidentiary criteria as qualified events, but likely were nonetheless,” he said. “This is an example of dichotomization of events being wasteful of information.”

Post-hoc exploratory analyses in PARAGON-HF were able to meet the commonly used standard, according to the FDA briefing document. Among the key findings of these analyses were:

• An analysis of investigator-reported events for the primary composite endpoint of total hospitalizations for heart failure (HHF) and cardiovascular (CV) death demonstrated a rate ratio (RR) of 0.84 (95% confidence interval 0.74- 0.97; P = .01).
• Investigator-reported events added 226 and 290 HHF events but decreased CV death by 56 and 58 events in the sacubitril/valsartan and valsartan arms, respectively. Hence, a net 170 and 232 events were added to the clinical endpoint committee–reported primary composite endpoint leading to a P value of .01, without a significant change in RR.
• Analysis of investigator-reported expanded primary composite endpoint events including total HHF, urgent HF visits, and CV death demonstrated a RR of 0.83 (95% CI, 0.73-0.95; P = .006. There were 136 and 173 investigator-reported urgent HF events in sacubitril/valsartan and valsartan arms, respectively.

Opening a floodgate?

Cynthia L. Chauhan, MSW, of Wichita, Kansas, who served as the consumer representative on the panel, questioned whether a decision to revisit the data on PARAGON-HF might lead drugmakers to seek to repurpose other failed trials.

“Are we opening any kind of floodgate for other researchers to go back and see this is an invitation to try to, for want of a better term, back-door their way into some approvals?” Ms. Chauhan asked.

Dr. Nissen assured her that this concern was valid and would be considered. The goal would be to allow some flexibility in cases that merit further consideration, while preventing companies from data mining until they find some evidence to support an FDA application, he said.

Re-analyzing trials “should be done carefully, conservatively, and only when it really is compelling that the public interest supports it,” Dr. Nissen stressed.

Panelists reported no conflicts of interest related to the topic of the meeting.
 

UPDATED DECEMBER 17

A panel of federal advisers on Tuesday effectively backed a bid to expand approval of sacubitril/valsartan for use in a form of heart failure for which there is not yet an approved medication.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The U.S. Food and Drug Administration asked its Cardiovascular and Renal Drugs Advisory Committee to broadly consider whether new analyses of data from the PARAGON-HF trial, combined with other information, could support use of sacubitril/valsartan (Entresto, Novartis) in heart failure with preserved ejection fraction (HFpEF).

The advisory committee voted 12-1 on this question, which can be seen as a marker for an expanded approval: “Does PARAGON-HF, perhaps supported by previous studies, provide sufficient evidence to support any indication?”

The dissenting vote was cast by the panel’s chairperson, Julia B. Lewis, MD, a professor of medicine from Vanderbilt University. In explaining her vote, Dr. Lewis cited concerns about expanding use of the drug, which has a potential for hypotension. But she noted that the rest of the panelists were “impressed by the totality of the evidence” presented, including a willingness to take a new look at the PARAGON-HF trial. This study was perceived at first pass as having failed to prove a benefit for people with HFpEF.

The 2019 initial unveiling of the PARAGON-HF results had dampened hopes for an evidence-based drug therapy for HFpEF. Patients treated with the first-of-its-kind renin-angiotensin system (RAS) inhibitor, compared with those who received standard valsartan, had 13% fewer heart failure hospitalizations or cardiovascular (CV) deaths over an average of about 3 years, but the difference missed significance at a P value of .059.

“Everybody agreed that the P value of .05 was not written in stone,” Dr. Lewis said in summarizing the panelists’ views on the voting question.

At the FDA’s request, the panel also addressed several other questions without voting on them. The agency asked the panel to describe the patient population for whom an expanded approval would be appropriate. The FDA initially approved sacubitril/valsartan in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Novartis in April submitted an application to the FDA, seeking to expand the use of sacubitril/valsartan from the currently approved indication for the treatment of chronic heart failure (CHF) patients with reduced ejection fraction (HFrEF) to include what the company terms “the adjacent population of patients with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) below normal.” The American Society of Echocardiography and European Association of Cardiovascular Imaging define normal LVEF and normal range (±2 standard deviations) as 62% (range, 52%-72%) in men and 64% (range, 54%-74%) in women, Novartis said in its briefing materials for the meeting.

FDA panelist Christopher M. O’Connor, MD, for example, suggested that an expanded approval could allow for use of sacubitril/valsartan for the reduction of heart failure or hospitalization in patients with mildly reduced ejection fraction as defined by greater than 45% through 55%. FDA panelist C. Noel Bairey Merz, MD, director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles, suggested extending this to 57% to acknowledge the higher threshold for women.

Another FDA panelist, Steven E. Nissen, MD, of the Cleveland Clinic, argued against use of imprecise terms in defining an expanded patient population for sacubitril/valsartan. If used in the right patient population, the drug could provide a benefit for people who have active heart failure with symptoms, including preventing hospitalizations and renal disease, he said.

“If you are symptomatic with a syndrome that’s consistent with heart failure and you have an ejection fraction below the lower limits of normal, I believe it’s in the public interest for you to get sacubitril/valsartan,” Dr. Nissen said.

The FDA usually follows the advice of its panels, but is not obligated to. But in this case, the agency staff were clearly seeking a path for an expanded approval of sacubitril/valsartan.


 

Challenging a standard

The FDA had encouraged Novartis to submit the supplementary application for the HFpEF indication and even suggested some of the post-hoc analyses, the agency staff said in a briefing document for the meeting.

PARAGON-HF illustrated some of the agency’s concerns about missed opportunities in general in large research trials. Some events of interest in studies may be miscounted due to a lack of information such as a requirement for the presence of physical examination findings that are not documented in the patient’s dossier, the FDA staff said.

“We would like to consider giving ‘partial credit’ to events based on the level of evidence provided, e.g., use of an ordinal variable rather than a dichotomous ‘yes’ or ‘no,’ ” the staff said in the briefing document.

At the panel meeting, Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, told the panelists there is no basis in law for setting a P value of .05 as the benchmark on whether to declare a trial a success or failure.

“I wanted to take a few minutes and make sure that you on the committee understands what flexibility you have in addressing the case study in question,” Dr. Stockbridge said at the start of the meeting.

He then reviewed cases where the FDA had approved claims for cardiac medicines that had not shown desired results in key tests. These include approval of enalapril for use in asymptomatic left ventricular dysfunction on the basis of the SOLVD-Prevention trial, approval of digoxin for heart failure on the basis of the DIG study, and approval of carvedilol for reduced ejection fraction following myocardial infarction on

the basis of the CAPRICORN study, Dr. Stockbridge said.

In reviewing the data for sacubitril/valsartan, FDA staff noted a similarity between investigator-reported and adjudicated results, Stockbridge said.

“This suggested that there were events that did not need all evidentiary criteria as qualified events, but likely were nonetheless,” he said. “This is an example of dichotomization of events being wasteful of information.”

Post-hoc exploratory analyses in PARAGON-HF were able to meet the commonly used standard, according to the FDA briefing document. Among the key findings of these analyses were:

• An analysis of investigator-reported events for the primary composite endpoint of total hospitalizations for heart failure (HHF) and cardiovascular (CV) death demonstrated a rate ratio (RR) of 0.84 (95% confidence interval 0.74- 0.97; P = .01).
• Investigator-reported events added 226 and 290 HHF events but decreased CV death by 56 and 58 events in the sacubitril/valsartan and valsartan arms, respectively. Hence, a net 170 and 232 events were added to the clinical endpoint committee–reported primary composite endpoint leading to a P value of .01, without a significant change in RR.
• Analysis of investigator-reported expanded primary composite endpoint events including total HHF, urgent HF visits, and CV death demonstrated a RR of 0.83 (95% CI, 0.73-0.95; P = .006. There were 136 and 173 investigator-reported urgent HF events in sacubitril/valsartan and valsartan arms, respectively.

Opening a floodgate?

Cynthia L. Chauhan, MSW, of Wichita, Kansas, who served as the consumer representative on the panel, questioned whether a decision to revisit the data on PARAGON-HF might lead drugmakers to seek to repurpose other failed trials.

“Are we opening any kind of floodgate for other researchers to go back and see this is an invitation to try to, for want of a better term, back-door their way into some approvals?” Ms. Chauhan asked.

Dr. Nissen assured her that this concern was valid and would be considered. The goal would be to allow some flexibility in cases that merit further consideration, while preventing companies from data mining until they find some evidence to support an FDA application, he said.

Re-analyzing trials “should be done carefully, conservatively, and only when it really is compelling that the public interest supports it,” Dr. Nissen stressed.

Panelists reported no conflicts of interest related to the topic of the meeting.
 

UPDATED DECEMBER 17

A panel of federal advisers on Tuesday effectively backed a bid to expand approval of sacubitril/valsartan for use in a form of heart failure for which there is not yet an approved medication.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The U.S. Food and Drug Administration asked its Cardiovascular and Renal Drugs Advisory Committee to broadly consider whether new analyses of data from the PARAGON-HF trial, combined with other information, could support use of sacubitril/valsartan (Entresto, Novartis) in heart failure with preserved ejection fraction (HFpEF).

The advisory committee voted 12-1 on this question, which can be seen as a marker for an expanded approval: “Does PARAGON-HF, perhaps supported by previous studies, provide sufficient evidence to support any indication?”

The dissenting vote was cast by the panel’s chairperson, Julia B. Lewis, MD, a professor of medicine from Vanderbilt University. In explaining her vote, Dr. Lewis cited concerns about expanding use of the drug, which has a potential for hypotension. But she noted that the rest of the panelists were “impressed by the totality of the evidence” presented, including a willingness to take a new look at the PARAGON-HF trial. This study was perceived at first pass as having failed to prove a benefit for people with HFpEF.

The 2019 initial unveiling of the PARAGON-HF results had dampened hopes for an evidence-based drug therapy for HFpEF. Patients treated with the first-of-its-kind renin-angiotensin system (RAS) inhibitor, compared with those who received standard valsartan, had 13% fewer heart failure hospitalizations or cardiovascular (CV) deaths over an average of about 3 years, but the difference missed significance at a P value of .059.

“Everybody agreed that the P value of .05 was not written in stone,” Dr. Lewis said in summarizing the panelists’ views on the voting question.

At the FDA’s request, the panel also addressed several other questions without voting on them. The agency asked the panel to describe the patient population for whom an expanded approval would be appropriate. The FDA initially approved sacubitril/valsartan in 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.

Novartis in April submitted an application to the FDA, seeking to expand the use of sacubitril/valsartan from the currently approved indication for the treatment of chronic heart failure (CHF) patients with reduced ejection fraction (HFrEF) to include what the company terms “the adjacent population of patients with preserved ejection fraction (HFpEF) who have a left ventricular ejection fraction (LVEF) below normal.” The American Society of Echocardiography and European Association of Cardiovascular Imaging define normal LVEF and normal range (±2 standard deviations) as 62% (range, 52%-72%) in men and 64% (range, 54%-74%) in women, Novartis said in its briefing materials for the meeting.

FDA panelist Christopher M. O’Connor, MD, for example, suggested that an expanded approval could allow for use of sacubitril/valsartan for the reduction of heart failure or hospitalization in patients with mildly reduced ejection fraction as defined by greater than 45% through 55%. FDA panelist C. Noel Bairey Merz, MD, director of the Barbra Streisand Women’s Heart Center at Cedars-Sinai Medical Center in Los Angeles, suggested extending this to 57% to acknowledge the higher threshold for women.

Another FDA panelist, Steven E. Nissen, MD, of the Cleveland Clinic, argued against use of imprecise terms in defining an expanded patient population for sacubitril/valsartan. If used in the right patient population, the drug could provide a benefit for people who have active heart failure with symptoms, including preventing hospitalizations and renal disease, he said.

“If you are symptomatic with a syndrome that’s consistent with heart failure and you have an ejection fraction below the lower limits of normal, I believe it’s in the public interest for you to get sacubitril/valsartan,” Dr. Nissen said.

The FDA usually follows the advice of its panels, but is not obligated to. But in this case, the agency staff were clearly seeking a path for an expanded approval of sacubitril/valsartan.


 

Challenging a standard

The FDA had encouraged Novartis to submit the supplementary application for the HFpEF indication and even suggested some of the post-hoc analyses, the agency staff said in a briefing document for the meeting.

PARAGON-HF illustrated some of the agency’s concerns about missed opportunities in general in large research trials. Some events of interest in studies may be miscounted due to a lack of information such as a requirement for the presence of physical examination findings that are not documented in the patient’s dossier, the FDA staff said.

“We would like to consider giving ‘partial credit’ to events based on the level of evidence provided, e.g., use of an ordinal variable rather than a dichotomous ‘yes’ or ‘no,’ ” the staff said in the briefing document.

At the panel meeting, Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, told the panelists there is no basis in law for setting a P value of .05 as the benchmark on whether to declare a trial a success or failure.

“I wanted to take a few minutes and make sure that you on the committee understands what flexibility you have in addressing the case study in question,” Dr. Stockbridge said at the start of the meeting.

He then reviewed cases where the FDA had approved claims for cardiac medicines that had not shown desired results in key tests. These include approval of enalapril for use in asymptomatic left ventricular dysfunction on the basis of the SOLVD-Prevention trial, approval of digoxin for heart failure on the basis of the DIG study, and approval of carvedilol for reduced ejection fraction following myocardial infarction on

the basis of the CAPRICORN study, Dr. Stockbridge said.

In reviewing the data for sacubitril/valsartan, FDA staff noted a similarity between investigator-reported and adjudicated results, Stockbridge said.

“This suggested that there were events that did not need all evidentiary criteria as qualified events, but likely were nonetheless,” he said. “This is an example of dichotomization of events being wasteful of information.”

Post-hoc exploratory analyses in PARAGON-HF were able to meet the commonly used standard, according to the FDA briefing document. Among the key findings of these analyses were:

• An analysis of investigator-reported events for the primary composite endpoint of total hospitalizations for heart failure (HHF) and cardiovascular (CV) death demonstrated a rate ratio (RR) of 0.84 (95% confidence interval 0.74- 0.97; P = .01).
• Investigator-reported events added 226 and 290 HHF events but decreased CV death by 56 and 58 events in the sacubitril/valsartan and valsartan arms, respectively. Hence, a net 170 and 232 events were added to the clinical endpoint committee–reported primary composite endpoint leading to a P value of .01, without a significant change in RR.
• Analysis of investigator-reported expanded primary composite endpoint events including total HHF, urgent HF visits, and CV death demonstrated a RR of 0.83 (95% CI, 0.73-0.95; P = .006. There were 136 and 173 investigator-reported urgent HF events in sacubitril/valsartan and valsartan arms, respectively.

Opening a floodgate?

Cynthia L. Chauhan, MSW, of Wichita, Kansas, who served as the consumer representative on the panel, questioned whether a decision to revisit the data on PARAGON-HF might lead drugmakers to seek to repurpose other failed trials.

“Are we opening any kind of floodgate for other researchers to go back and see this is an invitation to try to, for want of a better term, back-door their way into some approvals?” Ms. Chauhan asked.

Dr. Nissen assured her that this concern was valid and would be considered. The goal would be to allow some flexibility in cases that merit further consideration, while preventing companies from data mining until they find some evidence to support an FDA application, he said.

Re-analyzing trials “should be done carefully, conservatively, and only when it really is compelling that the public interest supports it,” Dr. Nissen stressed.

Panelists reported no conflicts of interest related to the topic of the meeting.
 

Many types of plastics pose an unrecognized threat to human health by leaching endocrine-disrupting chemicals, and a new report from the Endocrine Society and the International Pollutants Elimination Network presents their dangers and risks.

curtoicurto/Getty Images

Written in a consumer-friendly form designed to guide public interest groups and policy makers, the report also can be used by clinicians to inform discussions with patients about the potential dangers of plastics and how they can reduce their exposure to endocrine-disrupting chemicals.

The report, Plastics, EDCs, & Health, defines endocrine-disrupting chemicals (EDCs) as “an exogenous chemical, or mixture of chemicals, that interferes with any aspect of hormone action.” Hormones in the body must be released at specific times, and therefore interference with their normal activity can have profound effects on health in areas including growth and reproductive development, according to the report.

The available data show “more and more information about the different chemicals and the different effects they are having,” said lead author, Jodi Flaws, PhD, of the University of Illinois at Urbana-Champaign, in a virtual press conference accompanying the release of the report.

Although numerous EDCs have been identified, a recent study suggested that many potentially dangerous chemical additives remain unknown because they are identified as confidential or simply not well described, the report authors said. In addition, creation of more plastic products will likely lead to increased exposure to EDCs and make health problems worse, said report coauthor Pauliina Damdimopoulou, PhD, of the Karolinska Institutet in Stockholm.
 

Lesser-known EDCs populate consumer products

Most consumers are aware of bisphenol A and phthalates as known EDCs, said Dr. Flaws, but the report identifies other lesser-known EDCs including per- and polyfluoroalkyl substances (PFAS), dioxins, flame retardants, and UV stabilizers.

For example, PFAS have been used for decades in a range of consumer products including stain resistant clothes, fast food wrappers, carpet and furniture treatments, cookware, and firefighting foams, according to the report. Consequently, PFAS have become common in many water sources including surface water, drinking water, and ground water because of how they are disposed. “Consumption of fish and other aquatic creatures caught in waterways contaminated with PFAS also poses heightened risks due to bioaccumulation of persistent chemicals in these animals,” the report authors noted. Human exposures to PFAS have been documented in urine, serum, plasma, placenta, umbilical cord, breast milk, and fetal tissues, they added.

Brominated flame retardants are another lesser-known EDC highlighted in the report. These chemical additives are used in plastics such as electronics cases to reduce the spread of fire, as well as in furniture foam and other building materials, the authors wrote. UV stabilizers, which also have been linked to health problems, often are used in manufacturing cars and other machinery.

Microplastics create large risk

Microplastics, defined as plastic particles less than 5 mm in diameter, are another source of exposure to EDCs that is not well publicized, according to the report. Plastic waste disposal often leads to the release of microplastics, which can infiltrate soil and water. Plastic waste is often dumped or burned; outdoor burning of plastic causes emission of dioxins into the air and ground.

“Not only do microplastics contain endogenous chemical additives, which are not bound to the microplastic and can leach out of the microplastic and expose the population, they can also bind and accumulate toxic chemicals from the surrounding environment such as sea water and sediment,” the report authors said.

Recycling is not an easy answer, either. Often more chemicals are created and released during the process of using plastics to make other plastics, according to the report.

Overall, more awareness of the potential for increased exposure to EDCs and support of strategies to seek out alternatives to hazardous chemicals is needed at the global level, the authors wrote. For example, the European Union has proposed a chemicals strategy that includes improved classification of EDCs and banning identified EDCs in consumer products.

New data support ongoing dangers

“It was important to produce the report at this time because several new studies came out on the effects of EDCs from plastics on human health,” Dr. Flaws said in an interview. “Further, there was not previously a single source that brought together all the information in a manner that was targeted towards the public, policy makers, and others,” she said.

Dr. Flaws said that what has surprised her most in the recent research is the fact that plastics contain such a range of chemicals and EDCs.

“A good take-home message [from the report] is that plastics can contain endocrine-disrupting chemicals that can interfere with normal hormones and lead to adverse health outcomes,” she said. “I suggest limiting the use of plastics as much as possible. I know this is very hard to do, so if someone needs to use plastic, they should not heat food or drink in plastic containers,” she emphasized. Individuals also can limit reuse of plastics over and over,” she said. “Heating and repeated use/washing often causes plastics to leach EDCs into food and drink that we then get into our bodies.”

Additional research is needed to understand the mechanisms by which EDCs from plastics cause damage, Dr. Flaws emphasized. “Given that it is not possible to eliminate plastics at this time, if we understood mechanisms of action, we could develop ways to prevent toxicity or treat EDC-induced adverse health outcomes,” she said. “We also need research designed to develop plastics or ‘green materials’ that do not contain endocrine disruptors and do not cause health problems or damage the environment,” she noted.

The report was produced as a joint effort of the Endocrine Society and International Pollutants Elimination Network. The report authors had no financial conflicts to disclose.

Many types of plastics pose an unrecognized threat to human health by leaching endocrine-disrupting chemicals, and a new report from the Endocrine Society and the International Pollutants Elimination Network presents their dangers and risks.

curtoicurto/Getty Images

Written in a consumer-friendly form designed to guide public interest groups and policy makers, the report also can be used by clinicians to inform discussions with patients about the potential dangers of plastics and how they can reduce their exposure to endocrine-disrupting chemicals.

The report, Plastics, EDCs, & Health, defines endocrine-disrupting chemicals (EDCs) as “an exogenous chemical, or mixture of chemicals, that interferes with any aspect of hormone action.” Hormones in the body must be released at specific times, and therefore interference with their normal activity can have profound effects on health in areas including growth and reproductive development, according to the report.

The available data show “more and more information about the different chemicals and the different effects they are having,” said lead author, Jodi Flaws, PhD, of the University of Illinois at Urbana-Champaign, in a virtual press conference accompanying the release of the report.

Although numerous EDCs have been identified, a recent study suggested that many potentially dangerous chemical additives remain unknown because they are identified as confidential or simply not well described, the report authors said. In addition, creation of more plastic products will likely lead to increased exposure to EDCs and make health problems worse, said report coauthor Pauliina Damdimopoulou, PhD, of the Karolinska Institutet in Stockholm.
 

Lesser-known EDCs populate consumer products

Most consumers are aware of bisphenol A and phthalates as known EDCs, said Dr. Flaws, but the report identifies other lesser-known EDCs including per- and polyfluoroalkyl substances (PFAS), dioxins, flame retardants, and UV stabilizers.

For example, PFAS have been used for decades in a range of consumer products including stain resistant clothes, fast food wrappers, carpet and furniture treatments, cookware, and firefighting foams, according to the report. Consequently, PFAS have become common in many water sources including surface water, drinking water, and ground water because of how they are disposed. “Consumption of fish and other aquatic creatures caught in waterways contaminated with PFAS also poses heightened risks due to bioaccumulation of persistent chemicals in these animals,” the report authors noted. Human exposures to PFAS have been documented in urine, serum, plasma, placenta, umbilical cord, breast milk, and fetal tissues, they added.

Brominated flame retardants are another lesser-known EDC highlighted in the report. These chemical additives are used in plastics such as electronics cases to reduce the spread of fire, as well as in furniture foam and other building materials, the authors wrote. UV stabilizers, which also have been linked to health problems, often are used in manufacturing cars and other machinery.

Microplastics create large risk

Microplastics, defined as plastic particles less than 5 mm in diameter, are another source of exposure to EDCs that is not well publicized, according to the report. Plastic waste disposal often leads to the release of microplastics, which can infiltrate soil and water. Plastic waste is often dumped or burned; outdoor burning of plastic causes emission of dioxins into the air and ground.

“Not only do microplastics contain endogenous chemical additives, which are not bound to the microplastic and can leach out of the microplastic and expose the population, they can also bind and accumulate toxic chemicals from the surrounding environment such as sea water and sediment,” the report authors said.

Recycling is not an easy answer, either. Often more chemicals are created and released during the process of using plastics to make other plastics, according to the report.

Overall, more awareness of the potential for increased exposure to EDCs and support of strategies to seek out alternatives to hazardous chemicals is needed at the global level, the authors wrote. For example, the European Union has proposed a chemicals strategy that includes improved classification of EDCs and banning identified EDCs in consumer products.

New data support ongoing dangers

“It was important to produce the report at this time because several new studies came out on the effects of EDCs from plastics on human health,” Dr. Flaws said in an interview. “Further, there was not previously a single source that brought together all the information in a manner that was targeted towards the public, policy makers, and others,” she said.

Dr. Flaws said that what has surprised her most in the recent research is the fact that plastics contain such a range of chemicals and EDCs.

“A good take-home message [from the report] is that plastics can contain endocrine-disrupting chemicals that can interfere with normal hormones and lead to adverse health outcomes,” she said. “I suggest limiting the use of plastics as much as possible. I know this is very hard to do, so if someone needs to use plastic, they should not heat food or drink in plastic containers,” she emphasized. Individuals also can limit reuse of plastics over and over,” she said. “Heating and repeated use/washing often causes plastics to leach EDCs into food and drink that we then get into our bodies.”

Additional research is needed to understand the mechanisms by which EDCs from plastics cause damage, Dr. Flaws emphasized. “Given that it is not possible to eliminate plastics at this time, if we understood mechanisms of action, we could develop ways to prevent toxicity or treat EDC-induced adverse health outcomes,” she said. “We also need research designed to develop plastics or ‘green materials’ that do not contain endocrine disruptors and do not cause health problems or damage the environment,” she noted.

The report was produced as a joint effort of the Endocrine Society and International Pollutants Elimination Network. The report authors had no financial conflicts to disclose.

Many types of plastics pose an unrecognized threat to human health by leaching endocrine-disrupting chemicals, and a new report from the Endocrine Society and the International Pollutants Elimination Network presents their dangers and risks.

curtoicurto/Getty Images

Written in a consumer-friendly form designed to guide public interest groups and policy makers, the report also can be used by clinicians to inform discussions with patients about the potential dangers of plastics and how they can reduce their exposure to endocrine-disrupting chemicals.

The report, Plastics, EDCs, & Health, defines endocrine-disrupting chemicals (EDCs) as “an exogenous chemical, or mixture of chemicals, that interferes with any aspect of hormone action.” Hormones in the body must be released at specific times, and therefore interference with their normal activity can have profound effects on health in areas including growth and reproductive development, according to the report.

The available data show “more and more information about the different chemicals and the different effects they are having,” said lead author, Jodi Flaws, PhD, of the University of Illinois at Urbana-Champaign, in a virtual press conference accompanying the release of the report.

Although numerous EDCs have been identified, a recent study suggested that many potentially dangerous chemical additives remain unknown because they are identified as confidential or simply not well described, the report authors said. In addition, creation of more plastic products will likely lead to increased exposure to EDCs and make health problems worse, said report coauthor Pauliina Damdimopoulou, PhD, of the Karolinska Institutet in Stockholm.
 

Lesser-known EDCs populate consumer products

Most consumers are aware of bisphenol A and phthalates as known EDCs, said Dr. Flaws, but the report identifies other lesser-known EDCs including per- and polyfluoroalkyl substances (PFAS), dioxins, flame retardants, and UV stabilizers.

For example, PFAS have been used for decades in a range of consumer products including stain resistant clothes, fast food wrappers, carpet and furniture treatments, cookware, and firefighting foams, according to the report. Consequently, PFAS have become common in many water sources including surface water, drinking water, and ground water because of how they are disposed. “Consumption of fish and other aquatic creatures caught in waterways contaminated with PFAS also poses heightened risks due to bioaccumulation of persistent chemicals in these animals,” the report authors noted. Human exposures to PFAS have been documented in urine, serum, plasma, placenta, umbilical cord, breast milk, and fetal tissues, they added.

Brominated flame retardants are another lesser-known EDC highlighted in the report. These chemical additives are used in plastics such as electronics cases to reduce the spread of fire, as well as in furniture foam and other building materials, the authors wrote. UV stabilizers, which also have been linked to health problems, often are used in manufacturing cars and other machinery.

Microplastics create large risk

Microplastics, defined as plastic particles less than 5 mm in diameter, are another source of exposure to EDCs that is not well publicized, according to the report. Plastic waste disposal often leads to the release of microplastics, which can infiltrate soil and water. Plastic waste is often dumped or burned; outdoor burning of plastic causes emission of dioxins into the air and ground.

“Not only do microplastics contain endogenous chemical additives, which are not bound to the microplastic and can leach out of the microplastic and expose the population, they can also bind and accumulate toxic chemicals from the surrounding environment such as sea water and sediment,” the report authors said.

Recycling is not an easy answer, either. Often more chemicals are created and released during the process of using plastics to make other plastics, according to the report.

Overall, more awareness of the potential for increased exposure to EDCs and support of strategies to seek out alternatives to hazardous chemicals is needed at the global level, the authors wrote. For example, the European Union has proposed a chemicals strategy that includes improved classification of EDCs and banning identified EDCs in consumer products.

New data support ongoing dangers

“It was important to produce the report at this time because several new studies came out on the effects of EDCs from plastics on human health,” Dr. Flaws said in an interview. “Further, there was not previously a single source that brought together all the information in a manner that was targeted towards the public, policy makers, and others,” she said.

Dr. Flaws said that what has surprised her most in the recent research is the fact that plastics contain such a range of chemicals and EDCs.

“A good take-home message [from the report] is that plastics can contain endocrine-disrupting chemicals that can interfere with normal hormones and lead to adverse health outcomes,” she said. “I suggest limiting the use of plastics as much as possible. I know this is very hard to do, so if someone needs to use plastic, they should not heat food or drink in plastic containers,” she emphasized. Individuals also can limit reuse of plastics over and over,” she said. “Heating and repeated use/washing often causes plastics to leach EDCs into food and drink that we then get into our bodies.”

Additional research is needed to understand the mechanisms by which EDCs from plastics cause damage, Dr. Flaws emphasized. “Given that it is not possible to eliminate plastics at this time, if we understood mechanisms of action, we could develop ways to prevent toxicity or treat EDC-induced adverse health outcomes,” she said. “We also need research designed to develop plastics or ‘green materials’ that do not contain endocrine disruptors and do not cause health problems or damage the environment,” she noted.

The report was produced as a joint effort of the Endocrine Society and International Pollutants Elimination Network. The report authors had no financial conflicts to disclose.

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

A version of this article originally appeared on Medscape.com.

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

A version of this article originally appeared on Medscape.com.

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

A version of this article originally appeared on Medscape.com.

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

A version of this article originally appeared on Medscape.com.

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

A version of this article originally appeared on Medscape.com.

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

A version of this article originally appeared on Medscape.com.

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.

Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.

Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.

Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.

The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.

Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”

Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.

The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.

Dr. Ananthakrishnan said he would check vitamin B_₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.

He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.

The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.

Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.

“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.

The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.

Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”

He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.

“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.

Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.

“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.

Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”

“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

In 2017, Global Pediatric Health published a case report series associated with the use of long-acting reversible contraceptives, specifically the etonogestrel implant. The cases highlighted challenging removals of the etonogestrel implants because of migration, fracture, or a bent device, and served as a caution to providers.

In November 2020, the makers of the etonogestrel implant (Merck) recommended a change in practice with the release of a notice to health care providers certified in the training of this product. This mass marketing blast included an updated warning and cautions for prescribers as well as patient information on the potential risks of migration, fracture, and bent devices attributable to trauma or sports. “Broken or Bent Implant (Section 5.16). The addition of the following underlined language: “There have been reports of broken or bent implants, which may be related to external forces (e.g., manipulation of the implant or contact sports) while in the patient’s arm. There have also been reports of migration of a broken implant fragment within the arm.”

Clearly the etonogestrel subdermal hormonal implant is an effective form of contraception and particularly beneficial in nonadherent sexually active teens who struggle to remember oral contraceptives. But it is important to be aware of this alert. Little is known about the type of trauma or rate of external force required to cause migration, fracture, or bend implants. This update requires adequate counseling of potential risks and complications of the etonogestrel implant, including the risk of migration, fracture, or bent devices specifically in the event of contact sports and trauma.
 

Ms. Thew is medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She had no relevant financial disclosures. Email Ms. Thew at pdnews@mdedge.com.

In 2017, Global Pediatric Health published a case report series associated with the use of long-acting reversible contraceptives, specifically the etonogestrel implant. The cases highlighted challenging removals of the etonogestrel implants because of migration, fracture, or a bent device, and served as a caution to providers.

In November 2020, the makers of the etonogestrel implant (Merck) recommended a change in practice with the release of a notice to health care providers certified in the training of this product. This mass marketing blast included an updated warning and cautions for prescribers as well as patient information on the potential risks of migration, fracture, and bent devices attributable to trauma or sports. “Broken or Bent Implant (Section 5.16). The addition of the following underlined language: “There have been reports of broken or bent implants, which may be related to external forces (e.g., manipulation of the implant or contact sports) while in the patient’s arm. There have also been reports of migration of a broken implant fragment within the arm.”

Clearly the etonogestrel subdermal hormonal implant is an effective form of contraception and particularly beneficial in nonadherent sexually active teens who struggle to remember oral contraceptives. But it is important to be aware of this alert. Little is known about the type of trauma or rate of external force required to cause migration, fracture, or bend implants. This update requires adequate counseling of potential risks and complications of the etonogestrel implant, including the risk of migration, fracture, or bent devices specifically in the event of contact sports and trauma.
 

Ms. Thew is medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She had no relevant financial disclosures. Email Ms. Thew at pdnews@mdedge.com.

In 2017, Global Pediatric Health published a case report series associated with the use of long-acting reversible contraceptives, specifically the etonogestrel implant. The cases highlighted challenging removals of the etonogestrel implants because of migration, fracture, or a bent device, and served as a caution to providers.

In November 2020, the makers of the etonogestrel implant (Merck) recommended a change in practice with the release of a notice to health care providers certified in the training of this product. This mass marketing blast included an updated warning and cautions for prescribers as well as patient information on the potential risks of migration, fracture, and bent devices attributable to trauma or sports. “Broken or Bent Implant (Section 5.16). The addition of the following underlined language: “There have been reports of broken or bent implants, which may be related to external forces (e.g., manipulation of the implant or contact sports) while in the patient’s arm. There have also been reports of migration of a broken implant fragment within the arm.”

Clearly the etonogestrel subdermal hormonal implant is an effective form of contraception and particularly beneficial in nonadherent sexually active teens who struggle to remember oral contraceptives. But it is important to be aware of this alert. Little is known about the type of trauma or rate of external force required to cause migration, fracture, or bend implants. This update requires adequate counseling of potential risks and complications of the etonogestrel implant, including the risk of migration, fracture, or bent devices specifically in the event of contact sports and trauma.
 

Ms. Thew is medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She had no relevant financial disclosures. Email Ms. Thew at pdnews@mdedge.com.

All pediatricians are relieved that the rates of children smoking cigarettes has dropped steadily since 2011. This decline seems to be associated with education on the dangers of cigarettes and fewer parents smoking. Perhaps less modeling of cigarette use in movies (although it increased again from 2010 to 2019) and lawsuits against advertisements targeting children also has helped.

licsiren/iStock/Getty Images

Vaping increases the risk of severe COVID-19 disease

While EVALI deaths dropped in months after being explained, the COVID-19 epidemic is now a much greater threat to vapers. Vaping, smoking, and even second-hand smoke are associated with a greater likelihood of infection with COVID-19. Vaping increases risk of severe COVID-19 disease because of its immediate paralysis of lung cilia. Sharing vape devices and touching one’s lips while using also increase the risk of virus transmission. Vaping and smoking increase the number of ACE2 receptors to which the SARS-CoV-2 virus attaches causing the characteristic cell damage, and suppresses macrophages and neutrophils, resulting in more smokers testing positive, being twice as likely to develop a severe illness and get hospitalized because of pneumonia from COVID-19, and being less likely to recover. Unfortunately, addressing this new threat to the immediate and long-term health of our patients appears to be more complicated than for addressing smoking tobacco. First of all, vaping is much more difficult to detect than smelly cigarettes sending smoke signals from behind the garage or in the school bathrooms. Many, if not most, adults do not recognize the vaping devices when they see them, as many are tiny and some look like computer thumb drives. The aerosol emitted when in use, while containing dangerous toxins, has less odor than tobacco smoke. Vaping equipment and ads have been designed to attract youth, including linking them to sports and music events. Vaping has been advertised as a way to wean off nicotine addiction, a claim that has some scientific evidence in adults, but at a lower dose of nicotine. Warning children about the dangers of marijuana vaping has been made less credible by the rapid expansion of legalization of marijuana around the United States, eliciting “I told you it was fine” reactions from youth. And the person vaping does not know what or how much of the psychoactive components are being delivered into their bodies. One Juul pod, for example, has the equivalent in nicotine of an entire pack of 20 cigarettes. They are highly addictive, especially to the developing brain, such that youth who vape are more likely to become addicted and to smoke cigarettes in the future.

Help from federal regulation has been weak

While all 50 states ban sales to youth, adults can still buy. Food and Drug Administration limitations on kid-friendly ads, and use of sweet, fruity, and mint flavorings that are most preferred by children, apply only to new producers. The FDA does not yet regulate content of vaping solutions.

So we pediatricians are on the front line for this new threat to prevent vaping or convince youth to cut down or quit. The first step in addressing vaping is being knowledgeable about its many known and emerging health risks. It may seem obvious that the dangers of vaping microscopic particles depends on the contents. Water vapor alone is not dangerous; in fact, we prescribe it in nebulizers. Unfortunately, the contents of different vaping products vary and are not well defined in different vape products. The process of using an electric current to vaporize a substance can make it more toxic than the precursor, and teens have little idea about the substances they are inhaling. The psychoactive components vary from nicotine to tetrahydrocannabinol in varying amounts. These have the well known effects of stimulation or a high, but also the potential adverse effects of poor concentration, agitation, and even psychosis. Most e-cigarettes contain nicotine, which is highly addictive and can harm adolescent brain development, which continues into the early- to mid-20s. About two-thirds of Juul users aged 15-24 years did not know that it always contains nicotine, as do 99% of all vape solutions (Centers for Disease Control and Prevention, 2020). Earlier use of nicotine is more highly associated with later addiction to tobacco products that cause lung damage, acid reflux, insulin resistance, harm to the testes, harm to fetuses, cancer, and heart disease.

E-cigarette aerosols also contain dozens of other harmful substances besides nicotine ranging from acetone, propylene glycol, and metals to formaldehyde and ethyl benzene. These same chemicals are part of familiar toxic substances such as antifreeze, paint thinner, and pesticides. These cause ear, eye and throat irritation, and impairments in the cardiovascular system reducing athletic ability – at the least. Some flavorings in vape fluids also are toxic. Even the residual left on furniture and floors is harmful to those coming in contact, including pets.
 

How to encourage teens not to vaping

Trying to scare youth about health hazards is not generally effective in stopping risk behaviors since adolescence is a time of perceived singularity (it does not apply to me) and even a sense of immortality. Teens also see peers who vape as being unaffected and decide on using based on this small personal sample instead of valid statistics.

But teens do pay some attention to peer models or influencers saying why they do not use. One source of such testimony you can refer to is videos of inspiring athletes, musicians, and other “cool” young adults found on the naturalhigh.org website. You may know other examples of community teens desisting you can reference.

Parent rules, and less so advice, against smoking have been shown to be effective in deterring youth cigarette smoking. Because parents are less aware of vaping and its dangers, another step we can take is educating parents in our practices about vaping, its variable forms, its effects, and dangers, supplying authoritative materials, and advising them to talk with their children. Other steps the American Academy of Pediatrics recommends regarding smoking is for parents to be a role model of not using or try to quit, designate the house and car as smoking free, avoid children viewing smoking in media, tell their children about the side effects, and encourage their children who use to quit. Parents also can encourage schools to teach and have rules about smoking and vaping (e.g., med.stanford.edu/tobaccopreventiontoolkit.html).

Another approach we have been using is to not only screen for all substance use, but also to gather information about the teen’s strengths, activities, and life goals both to enhance rapport and to reference during motivational interviewing as reasons to avoid, reduce, or quit vaping. Motivational interviewing has been shown to help patients make healthier lifestyle choices by nonjudgmentally exploring their pros and cons in a conversation that takes into account readiness to change. This fits well with the stage of developing autonomy when teens want above all to make their own decisions. The cons of using can be discussed as including the effects and side effects of vaping interfering with their favored activities and moving towards their identified goals. Praising abstinence and asking them to show you how they could decline offers to vape are valuable reinforcement you can provide.

Finally, we all know that teens hate being manipulated. Vaping education we provide can make it clear that youth are being tricked by companies – most being large cigarette producers who know the dangers of vaping – into getting addicted so these companies can get rich on their money.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

All pediatricians are relieved that the rates of children smoking cigarettes has dropped steadily since 2011. This decline seems to be associated with education on the dangers of cigarettes and fewer parents smoking. Perhaps less modeling of cigarette use in movies (although it increased again from 2010 to 2019) and lawsuits against advertisements targeting children also has helped.

licsiren/iStock/Getty Images

Vaping increases the risk of severe COVID-19 disease

While EVALI deaths dropped in months after being explained, the COVID-19 epidemic is now a much greater threat to vapers. Vaping, smoking, and even second-hand smoke are associated with a greater likelihood of infection with COVID-19. Vaping increases risk of severe COVID-19 disease because of its immediate paralysis of lung cilia. Sharing vape devices and touching one’s lips while using also increase the risk of virus transmission. Vaping and smoking increase the number of ACE2 receptors to which the SARS-CoV-2 virus attaches causing the characteristic cell damage, and suppresses macrophages and neutrophils, resulting in more smokers testing positive, being twice as likely to develop a severe illness and get hospitalized because of pneumonia from COVID-19, and being less likely to recover. Unfortunately, addressing this new threat to the immediate and long-term health of our patients appears to be more complicated than for addressing smoking tobacco. First of all, vaping is much more difficult to detect than smelly cigarettes sending smoke signals from behind the garage or in the school bathrooms. Many, if not most, adults do not recognize the vaping devices when they see them, as many are tiny and some look like computer thumb drives. The aerosol emitted when in use, while containing dangerous toxins, has less odor than tobacco smoke. Vaping equipment and ads have been designed to attract youth, including linking them to sports and music events. Vaping has been advertised as a way to wean off nicotine addiction, a claim that has some scientific evidence in adults, but at a lower dose of nicotine. Warning children about the dangers of marijuana vaping has been made less credible by the rapid expansion of legalization of marijuana around the United States, eliciting “I told you it was fine” reactions from youth. And the person vaping does not know what or how much of the psychoactive components are being delivered into their bodies. One Juul pod, for example, has the equivalent in nicotine of an entire pack of 20 cigarettes. They are highly addictive, especially to the developing brain, such that youth who vape are more likely to become addicted and to smoke cigarettes in the future.

Help from federal regulation has been weak

While all 50 states ban sales to youth, adults can still buy. Food and Drug Administration limitations on kid-friendly ads, and use of sweet, fruity, and mint flavorings that are most preferred by children, apply only to new producers. The FDA does not yet regulate content of vaping solutions.

So we pediatricians are on the front line for this new threat to prevent vaping or convince youth to cut down or quit. The first step in addressing vaping is being knowledgeable about its many known and emerging health risks. It may seem obvious that the dangers of vaping microscopic particles depends on the contents. Water vapor alone is not dangerous; in fact, we prescribe it in nebulizers. Unfortunately, the contents of different vaping products vary and are not well defined in different vape products. The process of using an electric current to vaporize a substance can make it more toxic than the precursor, and teens have little idea about the substances they are inhaling. The psychoactive components vary from nicotine to tetrahydrocannabinol in varying amounts. These have the well known effects of stimulation or a high, but also the potential adverse effects of poor concentration, agitation, and even psychosis. Most e-cigarettes contain nicotine, which is highly addictive and can harm adolescent brain development, which continues into the early- to mid-20s. About two-thirds of Juul users aged 15-24 years did not know that it always contains nicotine, as do 99% of all vape solutions (Centers for Disease Control and Prevention, 2020). Earlier use of nicotine is more highly associated with later addiction to tobacco products that cause lung damage, acid reflux, insulin resistance, harm to the testes, harm to fetuses, cancer, and heart disease.

E-cigarette aerosols also contain dozens of other harmful substances besides nicotine ranging from acetone, propylene glycol, and metals to formaldehyde and ethyl benzene. These same chemicals are part of familiar toxic substances such as antifreeze, paint thinner, and pesticides. These cause ear, eye and throat irritation, and impairments in the cardiovascular system reducing athletic ability – at the least. Some flavorings in vape fluids also are toxic. Even the residual left on furniture and floors is harmful to those coming in contact, including pets.
 

How to encourage teens not to vaping

Trying to scare youth about health hazards is not generally effective in stopping risk behaviors since adolescence is a time of perceived singularity (it does not apply to me) and even a sense of immortality. Teens also see peers who vape as being unaffected and decide on using based on this small personal sample instead of valid statistics.

But teens do pay some attention to peer models or influencers saying why they do not use. One source of such testimony you can refer to is videos of inspiring athletes, musicians, and other “cool” young adults found on the naturalhigh.org website. You may know other examples of community teens desisting you can reference.

Parent rules, and less so advice, against smoking have been shown to be effective in deterring youth cigarette smoking. Because parents are less aware of vaping and its dangers, another step we can take is educating parents in our practices about vaping, its variable forms, its effects, and dangers, supplying authoritative materials, and advising them to talk with their children. Other steps the American Academy of Pediatrics recommends regarding smoking is for parents to be a role model of not using or try to quit, designate the house and car as smoking free, avoid children viewing smoking in media, tell their children about the side effects, and encourage their children who use to quit. Parents also can encourage schools to teach and have rules about smoking and vaping (e.g., med.stanford.edu/tobaccopreventiontoolkit.html).

Another approach we have been using is to not only screen for all substance use, but also to gather information about the teen’s strengths, activities, and life goals both to enhance rapport and to reference during motivational interviewing as reasons to avoid, reduce, or quit vaping. Motivational interviewing has been shown to help patients make healthier lifestyle choices by nonjudgmentally exploring their pros and cons in a conversation that takes into account readiness to change. This fits well with the stage of developing autonomy when teens want above all to make their own decisions. The cons of using can be discussed as including the effects and side effects of vaping interfering with their favored activities and moving towards their identified goals. Praising abstinence and asking them to show you how they could decline offers to vape are valuable reinforcement you can provide.

Finally, we all know that teens hate being manipulated. Vaping education we provide can make it clear that youth are being tricked by companies – most being large cigarette producers who know the dangers of vaping – into getting addicted so these companies can get rich on their money.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

All pediatricians are relieved that the rates of children smoking cigarettes has dropped steadily since 2011. This decline seems to be associated with education on the dangers of cigarettes and fewer parents smoking. Perhaps less modeling of cigarette use in movies (although it increased again from 2010 to 2019) and lawsuits against advertisements targeting children also has helped.

licsiren/iStock/Getty Images

Vaping increases the risk of severe COVID-19 disease

While EVALI deaths dropped in months after being explained, the COVID-19 epidemic is now a much greater threat to vapers. Vaping, smoking, and even second-hand smoke are associated with a greater likelihood of infection with COVID-19. Vaping increases risk of severe COVID-19 disease because of its immediate paralysis of lung cilia. Sharing vape devices and touching one’s lips while using also increase the risk of virus transmission. Vaping and smoking increase the number of ACE2 receptors to which the SARS-CoV-2 virus attaches causing the characteristic cell damage, and suppresses macrophages and neutrophils, resulting in more smokers testing positive, being twice as likely to develop a severe illness and get hospitalized because of pneumonia from COVID-19, and being less likely to recover. Unfortunately, addressing this new threat to the immediate and long-term health of our patients appears to be more complicated than for addressing smoking tobacco. First of all, vaping is much more difficult to detect than smelly cigarettes sending smoke signals from behind the garage or in the school bathrooms. Many, if not most, adults do not recognize the vaping devices when they see them, as many are tiny and some look like computer thumb drives. The aerosol emitted when in use, while containing dangerous toxins, has less odor than tobacco smoke. Vaping equipment and ads have been designed to attract youth, including linking them to sports and music events. Vaping has been advertised as a way to wean off nicotine addiction, a claim that has some scientific evidence in adults, but at a lower dose of nicotine. Warning children about the dangers of marijuana vaping has been made less credible by the rapid expansion of legalization of marijuana around the United States, eliciting “I told you it was fine” reactions from youth. And the person vaping does not know what or how much of the psychoactive components are being delivered into their bodies. One Juul pod, for example, has the equivalent in nicotine of an entire pack of 20 cigarettes. They are highly addictive, especially to the developing brain, such that youth who vape are more likely to become addicted and to smoke cigarettes in the future.

Help from federal regulation has been weak

While all 50 states ban sales to youth, adults can still buy. Food and Drug Administration limitations on kid-friendly ads, and use of sweet, fruity, and mint flavorings that are most preferred by children, apply only to new producers. The FDA does not yet regulate content of vaping solutions.

So we pediatricians are on the front line for this new threat to prevent vaping or convince youth to cut down or quit. The first step in addressing vaping is being knowledgeable about its many known and emerging health risks. It may seem obvious that the dangers of vaping microscopic particles depends on the contents. Water vapor alone is not dangerous; in fact, we prescribe it in nebulizers. Unfortunately, the contents of different vaping products vary and are not well defined in different vape products. The process of using an electric current to vaporize a substance can make it more toxic than the precursor, and teens have little idea about the substances they are inhaling. The psychoactive components vary from nicotine to tetrahydrocannabinol in varying amounts. These have the well known effects of stimulation or a high, but also the potential adverse effects of poor concentration, agitation, and even psychosis. Most e-cigarettes contain nicotine, which is highly addictive and can harm adolescent brain development, which continues into the early- to mid-20s. About two-thirds of Juul users aged 15-24 years did not know that it always contains nicotine, as do 99% of all vape solutions (Centers for Disease Control and Prevention, 2020). Earlier use of nicotine is more highly associated with later addiction to tobacco products that cause lung damage, acid reflux, insulin resistance, harm to the testes, harm to fetuses, cancer, and heart disease.

E-cigarette aerosols also contain dozens of other harmful substances besides nicotine ranging from acetone, propylene glycol, and metals to formaldehyde and ethyl benzene. These same chemicals are part of familiar toxic substances such as antifreeze, paint thinner, and pesticides. These cause ear, eye and throat irritation, and impairments in the cardiovascular system reducing athletic ability – at the least. Some flavorings in vape fluids also are toxic. Even the residual left on furniture and floors is harmful to those coming in contact, including pets.
 

How to encourage teens not to vaping

Trying to scare youth about health hazards is not generally effective in stopping risk behaviors since adolescence is a time of perceived singularity (it does not apply to me) and even a sense of immortality. Teens also see peers who vape as being unaffected and decide on using based on this small personal sample instead of valid statistics.

But teens do pay some attention to peer models or influencers saying why they do not use. One source of such testimony you can refer to is videos of inspiring athletes, musicians, and other “cool” young adults found on the naturalhigh.org website. You may know other examples of community teens desisting you can reference.

Parent rules, and less so advice, against smoking have been shown to be effective in deterring youth cigarette smoking. Because parents are less aware of vaping and its dangers, another step we can take is educating parents in our practices about vaping, its variable forms, its effects, and dangers, supplying authoritative materials, and advising them to talk with their children. Other steps the American Academy of Pediatrics recommends regarding smoking is for parents to be a role model of not using or try to quit, designate the house and car as smoking free, avoid children viewing smoking in media, tell their children about the side effects, and encourage their children who use to quit. Parents also can encourage schools to teach and have rules about smoking and vaping (e.g., med.stanford.edu/tobaccopreventiontoolkit.html).

Another approach we have been using is to not only screen for all substance use, but also to gather information about the teen’s strengths, activities, and life goals both to enhance rapport and to reference during motivational interviewing as reasons to avoid, reduce, or quit vaping. Motivational interviewing has been shown to help patients make healthier lifestyle choices by nonjudgmentally exploring their pros and cons in a conversation that takes into account readiness to change. This fits well with the stage of developing autonomy when teens want above all to make their own decisions. The cons of using can be discussed as including the effects and side effects of vaping interfering with their favored activities and moving towards their identified goals. Praising abstinence and asking them to show you how they could decline offers to vape are valuable reinforcement you can provide.

Finally, we all know that teens hate being manipulated. Vaping education we provide can make it clear that youth are being tricked by companies – most being large cigarette producers who know the dangers of vaping – into getting addicted so these companies can get rich on their money.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

A version of this article originally appeared on Medscape.com.

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

A version of this article originally appeared on Medscape.com.

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID. 

A version of this article originally appeared on Medscape.com.